Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2021 | May 01, 2021 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2021 | |
Entity File Number | 001-36792 | |
Entity Registrant Name | CYTOSORBENTS CORPORATION | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 98-0373793 | |
Entity Address, Address Line One | 7 Deer Park Drive | |
Entity Address, Address Line Two | Suite K | |
Entity Address, City or Town | Monmouth Junction | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 08852 | |
City Area Code | 732 | |
Local Phone Number | 329-8885 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | CTSO | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 43,319,297 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001175151 | |
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Current Assets: | ||
Cash and cash equivalents | $ 68,468,285 | $ 71,421,601 |
Grants and accounts receivable, net of allowance for doubtful accounts of $65,026 at March 31, 2021 and $46,851 at December 31, 2020 | 5,018,506 | 5,159,275 |
Inventories | 3,108,201 | 2,673,799 |
Prepaid expenses and other current assets | 3,039,722 | 3,198,460 |
Total current assets | 79,634,714 | 82,453,135 |
Property and equipment - net | 2,404,958 | 2,119,927 |
Right of use assets | 923,960 | 1,029,123 |
Other assets | 4,515,420 | 4,348,286 |
Total Assets | 87,479,052 | 89,950,471 |
Current Liabilities: | ||
Accounts payable | 1,677,565 | 1,835,082 |
Lease liability - current portion | 462,896 | 447,485 |
Accrued expenses and other current liabilities | 7,618,726 | 7,870,687 |
Total current liabilities | 9,759,187 | 10,153,254 |
Lease liability, net of current portion | 461,064 | 581,638 |
Total Liabilities | 10,220,251 | 10,734,892 |
Commitments and Contingencies (Note 6) | ||
Stockholders' Equity: | ||
Preferred Stock, Par Value $0.001, 5,000,000 shares authorized; -0- shares issued and outstanding at March 31, 2021 and December 31, 2020 | ||
Common Stock, Par Value $0.001, 100,000,000 shares authorized; 43,272,372 and 43,221,999 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 43,272 | 43,222 |
Additional paid-in capital | 278,586,339 | 277,533,082 |
Accumulated other comprehensive loss | (576,342) | (1,734,078) |
Accumulated deficit | (200,794,468) | (196,626,647) |
Total Stockholders' Equity | 77,258,801 | 79,215,579 |
Total Liabilities and Stockholders' Equity | $ 87,479,052 | $ 89,950,471 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 | Dec. 17, 2014 |
CONSOLIDATED BALANCE SHEETS | |||
Allowance for doubtful accounts | $ 65,026 | $ 46,851 | |
Preferred Stock, Par value | $ 0.001 | $ 0.001 | |
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 | |
Preferred Stock, Shares Issued | 0 | 0 | |
Common Stock, Par Value | $ 0.001 | $ 0.001 | $ 0.001 |
Number of common stock authorized | 100,000,000 | 100,000,000 | |
Common Stock, shares issued | 43,272,372 | 43,221,999 | |
Common Stock, shares outstanding | 43,272,372 | 43,221,999 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Revenue: | ||
Total revenue | $ 10,598,847 | $ 8,707,310 |
Cost of revenue | 2,751,444 | 2,384,842 |
Gross margin | 7,847,403 | 6,322,468 |
Other expenses: | ||
Research and development | 2,282,052 | 1,965,286 |
Legal, financial and other consulting | 707,839 | 519,002 |
Selling, general and administrative | 7,709,703 | 6,316,934 |
Total expenses | 10,699,594 | 8,801,222 |
Loss from operations | (2,852,191) | (2,478,754) |
Other expense: | ||
Interest expense, net | (10,124) | (305,537) |
Loss on foreign currency transactions | (1,305,506) | (668,488) |
Total other expense, net | (1,315,630) | (974,025) |
Loss before benefit from income taxes | (4,167,821) | (3,452,779) |
Benefit from income taxes | 0 | 0 |
Net loss attributable to common shareholders | $ (4,167,821) | $ (3,452,779) |
Basic and diluted net loss per common share | $ (0.10) | $ (0.10) |
Weighted average number of shares of common stock outstanding | 43,242,791 | 33,981,262 |
Net loss | $ (4,167,821) | $ (3,452,779) |
Other comprehensive income: | ||
Currency translation adjustment | 1,157,736 | 609,828 |
Comprehensive loss | (3,010,085) | (2,842,951) |
Product | ||
Revenue: | ||
Total revenue | 10,143,356 | 8,155,969 |
Cyto Sorb Sales | ||
Revenue: | ||
Total revenue | 10,143,356 | 8,155,969 |
Grant | ||
Revenue: | ||
Total revenue | $ 455,491 | $ 551,341 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total |
Balance at Dec. 31, 2019 | $ 32,616 | $ 191,648,907 | $ 525,978 | $ (188,789,459) | $ 3,418,042 |
Balance (in shares) at Dec. 31, 2019 | 32,616,107 | ||||
Stock based compensation - employees, consultants and directors | $ 0 | 729,429 | 0 | 0 | 729,429 |
Other comprehensive income: foreign translation adjustment | 0 | 0 | 609,828 | 0 | 609,828 |
Proceeds from exercise of stock options | $ 38 | 138,392 | 0 | 0 | 138,430 |
Proceeds from exercise of stock options (in shares) | 38,277 | ||||
Issuance of restricted stock options | $ 55 | 328,884 | 0 | 0 | 328,939 |
Issuance of restricted stock options (in shares) | 54,734 | ||||
Issuance of common stock - offerings, net of fees incurred | $ 3,421 | 19,538,200 | 0 | 0 | 19,541,621 |
Issuance of common stock - offerings, net of fees incurred (in shares) | 3,421,237 | ||||
Net loss | $ 0 | 0 | 0 | (3,452,779) | (3,452,779) |
Balance at Mar. 31, 2020 | $ 36,130 | 212,383,812 | 1,135,806 | (192,242,238) | 21,313,510 |
Balance (in shares) at Mar. 31, 2020 | 36,130,355 | ||||
Balance at Dec. 31, 2019 | $ 32,616 | 191,648,907 | 525,978 | (188,789,459) | 3,418,042 |
Balance (in shares) at Dec. 31, 2019 | 32,616,107 | ||||
Balance at Dec. 31, 2020 | $ 43,222 | 277,533,082 | (1,734,078) | (196,626,647) | 79,215,579 |
Balance (in shares) at Dec. 31, 2020 | 43,221,999 | ||||
Stock based compensation - employees, consultants and directors | $ 0 | 667,193 | 0 | 0 | 667,193 |
Other comprehensive income: foreign translation adjustment | 0 | 0 | 1,157,736 | 0 | 1,157,736 |
Proceeds from exercise of stock options | $ 15 | 76,538 | 0 | 0 | 76,553 |
Proceeds from exercise of stock options (in shares) | 15,257 | ||||
Cashless exercise of stock options | $ 2 | (2) | 0 | 0 | 0 |
Cashless exercise of stock options (in shares) | 1,774 | ||||
Issuance of restricted stock options | $ 33 | 309,528 | 0 | 0 | $ 309,561 |
Issuance of restricted stock options (in shares) | 33,342 | ||||
Issuance of common stock - offerings, net of fees incurred (in shares) | 4,301,869 | ||||
Net loss | $ 0 | 0 | 0 | (4,167,821) | $ (4,167,821) |
Balance at Mar. 31, 2021 | $ 43,272 | $ 278,586,339 | $ (576,342) | $ (200,794,468) | $ 77,258,801 |
Balance (in shares) at Mar. 31, 2021 | 43,272,372 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (4,167,821) | $ (3,452,779) |
Adjustments to reconcile net loss to net cash used by operating activities: | ||
Non-cash restricted stock unit compensation | 442,273 | 477,732 |
Depreciation and amortization | 156,322 | 181,368 |
Amortization of debt costs | 0 | 35,868 |
Bad debt expense | 19,720 | 7,862 |
Stock-based compensation | 667,193 | 729,429 |
Foreign currency transaction loss | 1,305,506 | 668,488 |
Changes in operating assets and liabilities: | ||
Grants and accounts receivable | (28,046) | (1,023,329) |
Inventories | (492,815) | 134,270 |
Prepaid expenses and other current assets | 144,489 | 87,107 |
Other assets | (23,501) | 0 |
Accounts payable and accrued expenses | (367,557) | (1,055,356) |
Net cash used by operating activities | (2,344,237) | (3,209,340) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (428,638) | (235,551) |
Payments for patent costs | (177,703) | (273,011) |
Net cash used by investing activities | (606,341) | (508,562) |
Cash flows from financing activities: | ||
Equity contributions - net of fees incurred | 0 | 17,743,226 |
Proceeds from exercise of stock options | 76,553 | 138,430 |
Net cash provided by financing activities | 76,553 | 17,881,656 |
Effect of exchange rates on cash | (79,291) | (7,151) |
Net change in cash and cash equivalents | (2,953,316) | 14,156,603 |
Cash and cash equivalents - beginning of period | 71,421,601 | 12,232,418 |
Cash and cash equivalents - end of period | 68,468,285 | 26,389,021 |
Supplemental disclosure of cash flow information: | ||
Cash paid during the year for interest | 0 | 318,879 |
Supplemental disclosure of non-cash financing activities: | ||
Settlement of accrued bonuses with restricted stock units | 309,561 | 328,939 |
Equity contribution proceeds in transit | $ 0 | $ 1,798,395 |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 3 Months Ended |
Mar. 31, 2021 | |
BASIS OF PRESENTATION | |
BASIS OF PRESENTATION | 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, 2020 included in the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (the “SEC”) on March 9, 2021. The results for the three months ended March 31, 2021 and 2020 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 March 31, 2021, the Company’s cash balance was approximately $68.5 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 substantially mitigated. |
PRINCIPAL BUSINESS ACTIVITY AND
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2021 | |
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 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-seven 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 January 2020, CytoSorb received European Union CE Mark label expansion to include the removal of ticagrelor during cardiopulmonary bypass in patients undergoing cardiothoracic surgery. In May 2020, CytoSorb also received European Union CE Mark label expansion to include rivaroxaban removal for the same indication. 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 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 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 16 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 2021 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, and CytoSorbents UK Limited, a wholly-owned subsidiary of CytoSorbents Medical, Inc. 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 the European subsidiary are included in operations. The Euro is the functional currency of the European Subsidiary. Foreign currency transaction loss included in net loss amounted to approximately $(1,306,000) and $(668,000) for the three months ended March 31, 2021 and 2020, 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 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. Management reviews accounts receivable periodically to determine collectability. Balances that are determined to be uncollectible are written off to the allowance for doubtful accounts. The allowance for doubtful accounts contains a general accrual for estimated bad debts and amounted to approximately $65,000 and $47,000 at March 31, 2021 and December 31, 2020, respectively. Inventories Inventories are valued at the lower of cost or net realizable value under the first in, first out (FIFO) method. At March 31, 2021 and December 31, 2020, the Company’s inventory was comprised of finished goods, which amounted to $1,622,401 and $1,164,635, respectively; work in process which amounted to $1,176,067 and $1,222,062, respectively; and raw materials, which amounted to $309,733 and $287,102, 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. Donated devices are removed from inventory and charged to selling, general and administrative expenses. 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 Grant 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 $154,000 and $31,500 for the three months ended March 31, 2021 and 2020, respectively, and are included in selling, general, and administrative expenses on the consolidated statements of operations and comprehensive loss. 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 March 31, 2021 or December 31, 2020. 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 government agencies in the United States. (See Note 4 for further information relating to the Company’s revenue.) As of March 31, 2021, one distributor accounted for approximately 21% of outstanding grants and accounts receivable. As of December 31, 2020, no agency, distributor/strategic partners or direct customer represented more than 10% of outstanding grants and accounts receivables. For the three months ended March 31, 2021 one distributor accounted for approximately 11% of the Company's total revenue and for the three months ended March 31, 2020, 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, accounts receivable, accounts payable and accrued expenses and other current liabilities 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 are 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 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). 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 $63,000 and $133,000, respectively, for the three months ended March 31, 2021 and 2020. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 3 Months Ended |
Mar. 31, 2021 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | 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 and 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. 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 million 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 year ended December 31, 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 $26.5 million. There were no sales during the three months ended March 31, 2021. 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 $27.2 million. In addition, during the year ended December 31, 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 for the three months ended March 31, 2021 and 2020 amounted to approximately $667,000 and $729,000, respectively. These amounts are included in the statement of operations under general and administrative expenses. The summary of the stock option activity for the three months ended March 31, 2021 is as follows: Weighted Weighted Average Average Remaining Exercise Price Contractual Shares per Share Life (Years) Outstanding, December 31, 2020 5,165,204 $ 6.36 7.26 Granted 65,880 $ 8.66 9.70 Forfeited (47,832) $ 6.25 — Expired — $ — — Exercised (17,031) $ 5.13 — Outstanding, March 31, 2021 5,166,221 $ 6.39 7.03 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 $8.23 to $11.39 per share) and expected life of the stock option (10 years), the current price of the underlying stock and its expected volatility (60.7 percent), expected dividends (-0- percent) on the stock and the risk free interest rate (ranging from 0.47 to 1.03 percent) for the expected term of the stock option. The intrinsic value is calculated as the difference between the market value as of March 31, 2021 of $8.68 and the exercise price of the shares. Options Outstanding Number Weighted Weighted Range of Outstanding at Average Average Aggregate Exercise March 31, Exercise Remaining Intrinsic Price 2021 Price Life (Years) Value $2.65 - $14.50 5,166,221 $ 6.39 7.03 $ 12,154,188 Options Exercisable Number Weighted Exercisable at Average Aggregate March 31, Exercise Intrinsic 2021 Price Value 3,677,482 $ 6.26 $ 9,179,984 The summary of the status of the Company’s non-vested options for the three months ended March 31, 2021 is as follows: Weighted Average Grant Date Shares Fair Value Non-vested, December 31, 2020 1,998,117 $ 4.12 Granted 65,880 $ 5.82 Forfeited (45,906) $ 3.83 Vested (529,352) $ 4.11 Non-vested, March 31, 2021 1,488,739 $ 4.10 As of March 31, 2021, the Company had approximately $5,300,000 of total unrecognized compensation cost related to stock options which will be amortized over approximately 35 months 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 employees of the Company. These restricted stock units will only vest upon a Change in Control of the Company, as defined in the Amended and Restated CytoSorbents Corporation 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, 2020 277,200 724,500 1,445,500 2,447,200 $ 19,504,184 Granted — — 39,000 39,000 Forfeited — — (3,000) (3,000) March 31, 2021 277,200 724,500 1,481,500 2,483,200 $ 21,554,176 Due to the uncertainty over whether these restricted stock units will vest, which only happens upon a Change in Control, no charge for these restricted stock units has been recorded in the consolidated statements of operations for the three months ended March 31, 2021 and 2020. Other Awards of Restricted Stock Units: 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, 2018. 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 months ended March 31, 2021 and 2020, the Company recorded a charge of approximately $11,000 and $9,000 respectively, related to these restricted stock unit awards. 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, 2019. 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 months ended March 31, 2021 and 2020, the Company recorded a charge of approximately $103,000 and $103,000, respectively, related to these restricted stock unit awards. 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, 2020. 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 months ended March 31, 2021 and 2020, the Company recorded a charge of approximately $274,000 and $366,000 respectively, related to these restricted stock unit awards. Additionally, in 2020 certain employees were offered 60,000 restricted stock units as a condition of their employment. These awards were valued at approximately $465,900 at the date of issuance. 30,000 of these restricted stock units vest upon the earlier of a Change in Control or one one one The following table outlines the restricted stock unit activity for the three months ended March 31, 2021: Weighted Average Grant Date Shares Fair Value Non-vested, December 31, 2020 173,972 $ 6.52 Granted 60,000 $ 7.77 Vested (61,902) $ 6.22 Non-vested, March 31, 2021 172,070 $ 7.06 |
REVENUE
REVENUE | 3 Months Ended |
Mar. 31, 2021 | |
REVENUE | |
REVENUE | 4. REVENUE The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended March 31, 2021: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ — $ 303,650 $ — $ 303,650 Germany 5,896,192 — — 5,896,192 All other countries 1,121,033 2,822,481 — 3,943,514 Total product revenue 7,017,225 3,126,131 — 10,143,356 Grant and other income: United States — 455,491 455,491 Total revenue $ 7,017,225 $ 3,126,131 $ 455,491 $ 10,598,847 The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended March 31, 2020: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ — $ — $ — $ — Germany 4,913,588 — — 4,913,588 All other countries 1,495,806 1,746,575 — 3,242,381 Total product revenue 6,409,394 1,746,575 — 8,155,969 Grant and other income: United States — — 551,341 551,341 Total revenue $ 6,409,394 $ 1,746,575 $ 551,341 $ 8,707,310 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. Both of these revenue streams are within the scope of this accounting pronouncement. 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. The majority of sales of the device are outside the United States, as CytoSorb is not yet approved for commercial sale in the United States. However, in April 2020, the Company was granted Emergency Use Authorization (“EUA”) of CytoSorb for use in critically-ill patients infected with COVID-19 by the United States Food and Drug Administration (the “FDA”). Direct sales outside the United States relate to sales to hospitals located in Germany, Switzerland, Austria, Belgium, Luxembourg, Poland, the Netherlands, Sweden, Denmark and Norway. Direct sales are fulfilled from the Company's office in Berlin, Germany. 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 amount in the contract. Most distributor's/strategic partner's contracts have minimum annual purchase requirements in order to maintain exclusivity in their respective territories. There is no additional consideration or monetary penalty that would be required to be paid to CytoSorbents 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. If billings on fixed price contracts exceed the costs incurred, revenue will be deferred to the extent of the excess billings. 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: March 31, 2021 December 31, 2020 Receivables, which are included in grants and accounts receivable $ 2,759,368 $ 2,996,679 Contract liabilities, which are included in accrued expenses and other current liabilities $ 1,313,239 $ 1,014,652 Contract receivables represent balances due from sales to distributors and amounts invoiced on grant contracts. Contract liabilities represent the value of free of charge goods and credit rebates earned in accordance with the terms of certain direct customer agreements and deferred grant revenue related to the billing on fixed price contracts in excess of costs incurred as of March 31, 2021 and December 31, 2020. |
LONG-TERM DEBT, NET
LONG-TERM DEBT, NET | 3 Months Ended |
Mar. 31, 2021 | |
LONG-TERM DEBT, NET | |
LONG-TERM DEBT, NET | 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 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 may be disbursed at the Borrower’s sole request prior to March 31, 2019 provided certain conditions are met (the “Term B Loan” and together with the Term A Loan, the “Term Loans”). On July 31, 2019, 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 million 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. On December 4, 2020 (the “Closing Date”), the Company closed on the Third Amendment (the “Third Amendment”) of its Amended Loan and Security Agreement with Bridge Bank. Under the terms of the Amendment, the Company repaid the outstanding principal balance of its existing $15 million term loans and simultaneously received a commitment from Bridge Bank to provide a new term loan of $15 million (the “New Term Loan”), if needed. Under the terms of the Third Amendment, the Company may, at its sole discretion, draw down the New Term Loan at any time over the next twelve months. The New Term Loan, if drawn, shall bear interest at the Index Rate (defined in the Amendment as the greater of 3.25% or the Prime Rate as published by the Wall Street Journal on the last business date of the month immediately preceding the month in which the interest will accrue) plus 1.25%. In addition, the Company would be required to make payments of interest-only commencing on the first day of the month after the New Term Loan was made until January 2023. The interest-only period may be further extended through July 2023 if the Company maintains compliance with certain conditions as outlined in the Amendment. Following the interest-only period, the Company will be required to make equal monthly payments of principal and interest until maturity of the New Term Loan. The maturity date of the New Term Loan is December 1, 2024. On the Closing Date, the Company was required to pay a non-refundable closing fee of $75,000. As of the Closing Date, the total unamortized loan costs related to the Term Loans amounted to approximately $45,000. These costs were written off on the Closing Date as a charge to interest expense. 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. On the Closing Date, the Company paid a final fee of $375,000. 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 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2021 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 6. COMMITMENTS AND CONTINGENCIES Customs Examination In October 2020, the Company received a notice from the German Customs Authorities that they would be conducting an audit of the Company’s import transactions for the years 2018 through 2020 in order to determine if any import taxes would be due. The audit commenced in early December 2020. The primary import activity of the Company is the importation of CytoSorb devices from the United States. The German Customs Authorities are challenging the Harmonized Code that the Company utilizes to import the CytoSorb devices into Germany. The code that has been utilized by the Company has zero import taxes associated with it. The German Customs Authorities have indicated that the Company’s device might be better classified under a different code which has a 1.7% tax attached to it. As part of the audit process, the Company has provided the German Customs Authorities with extensive information about the CytoSorb device, including data regarding the uses of the device, as well as the instructions for use. In addition, employees of the Company gave the auditors a technical presentation of the scientific properties of the device, focusing on it as an adsorber, as opposed to a filter. On March 15, 2021, based on a review of all the information presented to the German Customs Authority’s technical staff, the German Customs Authority informed us that the Company must use the code that carries the 1.7% tax. The audit process is on-going and the authorities have indicated it is expected to be completed by approximately June 30, 2021. Based on a thorough review of these facts, management has concluded that it is probable that this contingency is likely to occur. Approximately $132,000 of the expense relates to 2018, approximately $229,000 relates to 2019, approximately $371,000 relates to 2020 and approximately $89,000 relates to the three months ended March 31, 2021. Accordingly, an expense and related liability in the amount of approximately $821,000 has been recorded to cost of goods sold in the Company’s March 31, 2021 consolidated financial statements related to this contingency. 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 in 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 legal proceedings. Royalty Agreement Pursuant to an agreement dated August 11, 2003, an existing investor agreed to make a $4 million equity investment in the Company. These amounts were received by the Company in 2003. In connection with this agreement the Company granted the investor a perpetual royalty of 3% on all gross revenues received by the Company from the sale of its CytoSorb device which such rights were assigned to an existing investor in 2017. For the three months ended March 31, 2021 and 2020, the Company recorded royalty expenses of approximately $301,000 and $242,000, respectively. These expenses are included in selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss. License Agreement In an agreement dated September 1, 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 license fees 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 March 31, 2021 and 2020 per the terms of the license agreement, the Company recorded licensing expenses of approximately $501,000 and $404,000, respectively. These expenses are included in selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss. |
LEASES
LEASES | 3 Months Ended |
Mar. 31, 2021 | |
LEASES | |
LEASES | 7. 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. In Germany, the Company leases its operating facility under two operating lease agreements. These leases require combined base rent payments amounting to approximately $9,000 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. 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: March 31, December 31, 2021 2020 Right-of-use asset $ 923,960 $ 1,029,123 Total lease liability $ 923,960 $ 1,029,123 Less current portion (462,896) (447,485) Lease liability, net of current portion $ 461,064 $ 581,638 The maturities of the lease liabilities are as follows during the year ended March 31: 2022 $ 462,896 2023 145,153 2024 82,503 2025 90,386 2026 99,021 Thereafter 44,001 Total $ 923,960 For the three months ended March 31, 2021 and 2020, operating cash flows paid in connection with operating leases amounted to approximately $230,865 and $234,000, respectively. As of March 31, 2021 and December 31, 2020, the weighted average remaining lease term was 4.0 years, respectively. In March 2021, CytoSorbents Medical Inc. entered into a lease agreement for a new operating facility which contains office, laboratory, manufacturing and warehouse space. The commencement date of the lease is the date the landlord receives approval for the construction of certain improvements. The Initial Early Term begins on the commencement date (April 1, 2021) and lasts to June 1, 2021. The Early Term commences on June 1, 2021 and lasts until the date of issuance of the certificate of occupancy for the manufacturing space (expected to be September 30, 2021). The lease also contains two five-year six months liability In January 2021, CytoSorbents Europe GmbH entered into a lease for 1,068 square meters of additional warehouse space. The lease commences on April 1, 2021, requires monthly payments of base rent of $7,784 and other costs of approximately $239 and has a term of five years liability In April 2021, the Company entered into a Twentieth Amendment to Lease with the landlord which will become effective May 31, 2021. This amendment extends the term of the lease for the Company’s existing facility to May 31, 2022. The Company’s base rent will be approximately $35,000 per month. In addition, the Company is obligated to pay monthly operating expenses of approximately $30,000 per month. Under the terms of this amendment, the Company will vacate a portion of the space as of May 31, 2022. The Company will continue to lease the remaining space until December 31, 2022, at which time the Company will vacate the remaining space and the lease will terminate. The Company’s base rent for the remaining space will be approximately $20,000 per month. Monthly operating expenses will be approximately $11,000 per month. In addition, the Company agreed to increase its security deposit by approximately $54,000 to a total of $150,000. At the end of the lease term, the entire security deposit will be paid to the landlord for the purpose of making any needed repairs to the vacated premises, and the Company will have no further obligation to pay for repairs to the vacated premises. Effective April 1, 2021, the Company adjusted its incremental borrowing rate to the incremental borrowing rate used in the College Road lease and recalculated the right of use asset and lease liability under the amended terms of this lease. In addition, the Company also adjusted the incremental borrowing rate and related right of use asset and lease liability on the existing Germany office lease effective April 1, 2021. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 3 Months Ended |
Mar. 31, 2021 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | 8. NET LOSS PER SHARE Basic loss per share and diluted loss per share for the three months ended March 31, 2021 and 2020 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 options and restricted stock awards representing approximately 7,821,000 and 7,891,000 incremental shares at March 31, 2021 and 2020, respectively, have been excluded from the computation of diluted loss per share as they are anti-dilutive. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2021 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | 9. SUBSEQUENT EVENTS On April 28, 2021, the Company entered into a Twentieth Amendment to Lease with the landlord which will become effective May 31, 2021. This amendment extends the term of the lease for the Company’s existing facility to May 31, 2022. The Company’s base rent will be approximately $35,000 per month. Under the terms of this amendment, the Company will vacate a portion of the space as of May 31, 2022. The Company will continue to lease the remaining space until December 31, 2022, at which time the Company will vacate the remaining space and the lease will terminate. The Company’s base rent for the remaining space will be approximately $20,000 per month. In addition, the Company agreed to increase its security deposit by approximately $54,000 to a total of $150,000. At the end of the lease term, the entire security deposit will be paid to the landlord for the purpose of making any needed repairs to the vacated premises, and the Company will have no further obligation to pay for repairs to the vacated premises. On April 19, 2021, the Company received notification that it received a U.S. Army Medical Research Acquisition Activity Award (the “USAMRAAA”) entitled "Investigation of a potassium adsorber for the treatment of hyperkalemia induced by traumatic injury and acute kidney injury in austere medicine." The USAMRAAA Phase II Sequential Award, for up to $1,499,987, was granted to the Company to continue development of two novel and distinct treatment options for life-threatening hyperkalemia. This Award is being funded by the USAMRAAA under Contract No. W81XWH21C0045. On April 12, 2021, the Board of Directors approved the 2021 operating milestones. The Board also granted options to purchase 1,323,400 shares of Common Stock to certain specified Company employees. These options will vest only upon the achievement of certain specific, predetermined milestones related to the Company’s 2021 operating performance. Once awarded, these options will vest in four equal tranches, the first tranche vesting on the date of the award and the remaining tranches vest on each of the three subsequent anniversaries of the Board’s determination. The grant date fair value of these unvested options amounted to approximately $7,111,566 based upon the Black Sholes calculation. On April 12, 2021, the Board granted options to purchase 350,450 shares of Common Stock at an exercise price of $8.99 per share to certain executives of the Company. These options will vest in four equal tranches, the first tranche vesting on the date of the award and the remaining tranches vest on each of the three subsequent anniversaries of the award, subject to applicable executive’s continued service as of applicable vesting date. Additionally, on April 12, 2021, the Board granted 235,765 restricted stock units to certain executives of the Company. These restricted stock unit will vest in three equal tranches, the first tranche vesting on the date of the award and the remaining two tranches vest on the subsequent anniversaries of the award, subject to applicable executive’s continued service as of applicable vesting date and will be settled into Common Stock upon vesting. On April 12, 2021, the Board granted options to purchase 86,250 shares of Common Stock at an exercise price of $8.99 to non-employee members of the Company’s Board of Directors. One quarter of these options vested on April 12, 2021, one quarter will vest on June 30, 2021, one quarter will vest on September 30, 2021 and one quarter will vest on December 31, 2021, subject to the director’s continued service as of the applicable vesting date. |
PRINCIPAL BUSINESS ACTIVITY A_2
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Nature of Business | 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-seven 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 January 2020, CytoSorb received European Union CE Mark label expansion to include the removal of ticagrelor during cardiopulmonary bypass in patients undergoing cardiothoracic surgery. In May 2020, CytoSorb also received European Union CE Mark label expansion to include rivaroxaban removal for the same indication. 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 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 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 16 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 2021 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 | 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 | 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, and CytoSorbents UK Limited, a wholly-owned subsidiary of CytoSorbents Medical, Inc. 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 the European subsidiary are included in operations. The Euro is the functional currency of the European Subsidiary. Foreign currency transaction loss included in net loss amounted to approximately $(1,306,000) and $(668,000) for the three months ended March 31, 2021 and 2020, 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 loss as a component of stockholders’ equity. |
Cash and Cash Equivalents | 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 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. Management reviews accounts receivable periodically to determine collectability. Balances that are determined to be uncollectible are written off to the allowance for doubtful accounts. The allowance for doubtful accounts contains a general accrual for estimated bad debts and amounted to approximately $65,000 and $47,000 at March 31, 2021 and December 31, 2020, respectively. |
Inventories | Inventories Inventories are valued at the lower of cost or net realizable value under the first in, first out (FIFO) method. At March 31, 2021 and December 31, 2020, the Company’s inventory was comprised of finished goods, which amounted to $1,622,401 and $1,164,635, respectively; work in process which amounted to $1,176,067 and $1,222,062, respectively; and raw materials, which amounted to $309,733 and $287,102, 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. Donated devices are removed from inventory and charged to selling, general and administrative expenses. |
Property and Equipment | 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 | 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 | 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 | Revenue Recognition Product Sales Grant Revenue : |
Research and Development | Research and Development All research and development costs, payments to laboratories and research consultants are expensed when incurred. |
Advertising Expenses | Advertising Expenses Advertising expenses are charged to activities when incurred. Advertising expenses amounted to approximately $154,000 and $31,500 for the three months ended March 31, 2021 and 2020, respectively, and are included in selling, general, and administrative expenses on the consolidated statements of operations and comprehensive loss. |
Income Taxes | 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 March 31, 2021 or December 31, 2020. 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 | 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 | 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 government agencies in the United States. (See Note 4 for further information relating to the Company’s revenue.) As of March 31, 2021, one distributor accounted for approximately 21% of outstanding grants and accounts receivable. As of December 31, 2020, no agency, distributor/strategic partners or direct customer represented more than 10% of outstanding grants and accounts receivables. For the three months ended March 31, 2021 one distributor accounted for approximately 11% of the Company's total revenue and for the three months ended March 31, 2020, no agency, distributor, or direct customer represented more than 10% of the Company’s total revenue. |
Financial Instruments | Financial Instruments The carrying values of cash and cash equivalents, accounts receivable, accounts payable and accrued expenses and other current liabilities approximate their fair values due to their short-term nature. |
Net Loss Per Common Share | 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 are 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 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). |
Stock-Based Compensation | 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 | 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 $63,000 and $133,000, respectively, for the three months ended March 31, 2021 and 2020. |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
STOCKHOLDERS' EQUITY | |
Schedule Of Share Based Compensation Stock Options Activity | The summary of the stock option activity for the three months ended March 31, 2021 is as follows: Weighted Weighted Average Average Remaining Exercise Price Contractual Shares per Share Life (Years) Outstanding, December 31, 2020 5,165,204 $ 6.36 7.26 Granted 65,880 $ 8.66 9.70 Forfeited (47,832) $ 6.25 — Expired — $ — — Exercised (17,031) $ 5.13 — Outstanding, March 31, 2021 5,166,221 $ 6.39 7.03 |
Schedule of Share-based Compensation, Shares Authorized under Stock Option Plans, by Exercise Price Range | The intrinsic value is calculated as the difference between the market value as of March 31, 2021 of $8.68 and the exercise price of the shares. Options Outstanding Number Weighted Weighted Range of Outstanding at Average Average Aggregate Exercise March 31, Exercise Remaining Intrinsic Price 2021 Price Life (Years) Value $2.65 - $14.50 5,166,221 $ 6.39 7.03 $ 12,154,188 Options Exercisable Number Weighted Exercisable at Average Aggregate March 31, Exercise Intrinsic 2021 Price Value 3,677,482 $ 6.26 $ 9,179,984 |
Schedule Of Non vested Share Activity | The summary of the status of the Company’s non-vested options for the three months ended March 31, 2021 is as follows: Weighted Average Grant Date Shares Fair Value Non-vested, December 31, 2020 1,998,117 $ 4.12 Granted 65,880 $ 5.82 Forfeited (45,906) $ 3.83 Vested (529,352) $ 4.11 Non-vested, March 31, 2021 1,488,739 $ 4.10 |
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | 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, 2020 277,200 724,500 1,445,500 2,447,200 $ 19,504,184 Granted — — 39,000 39,000 Forfeited — — (3,000) (3,000) March 31, 2021 277,200 724,500 1,481,500 2,483,200 $ 21,554,176 |
Schedule Of Restricted Stock Unit Activity | Weighted Average Grant Date Shares Fair Value Non-vested, December 31, 2020 173,972 $ 6.52 Granted 60,000 $ 7.77 Vested (61,902) $ 6.22 Non-vested, March 31, 2021 172,070 $ 7.06 |
REVENUE (Tables)
REVENUE (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
REVENUE | |
Schedule of disaggregation of Revenue | The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended March 31, 2021: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ — $ 303,650 $ — $ 303,650 Germany 5,896,192 — — 5,896,192 All other countries 1,121,033 2,822,481 — 3,943,514 Total product revenue 7,017,225 3,126,131 — 10,143,356 Grant and other income: United States — 455,491 455,491 Total revenue $ 7,017,225 $ 3,126,131 $ 455,491 $ 10,598,847 The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended March 31, 2020: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ — $ — $ — $ — Germany 4,913,588 — — 4,913,588 All other countries 1,495,806 1,746,575 — 3,242,381 Total product revenue 6,409,394 1,746,575 — 8,155,969 Grant and other income: United States — — 551,341 551,341 Total revenue $ 6,409,394 $ 1,746,575 $ 551,341 $ 8,707,310 |
Schedule of contract with Customer, Asset and Liability | March 31, 2021 December 31, 2020 Receivables, which are included in grants and accounts receivable $ 2,759,368 $ 2,996,679 Contract liabilities, which are included in accrued expenses and other current liabilities $ 1,313,239 $ 1,014,652 Contract receivables represent balances due from sales to distributors and amounts invoiced on grant contracts. |
LEASES (Tables)
LEASES (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
LEASES | |
Schedule Of Right-Of-Asset And Related Lease Liability | March 31, December 31, 2021 2020 Right-of-use asset $ 923,960 $ 1,029,123 Total lease liability $ 923,960 $ 1,029,123 Less current portion (462,896) (447,485) Lease liability, net of current portion $ 461,064 $ 581,638 |
Schedule of Maturities of Lease Liabilities | The maturities of the lease liabilities are as follows during the year ended March 31: 2022 $ 462,896 2023 145,153 2024 82,503 2025 90,386 2026 99,021 Thereafter 44,001 Total $ 923,960 |
BASIS OF PRESENTATION (Details)
BASIS OF PRESENTATION (Details) - USD ($) $ / shares in Units, $ in Millions | Jul. 24, 2020 | Mar. 31, 2021 |
BASIS OF PRESENTATION [Line Items] | ||
Number of shares issued | 4,301,869 | |
Public offering price | $ 6.53 | |
Net proceeds from issuance of stock | $ 27.2 | |
Cash | $ 68.5 | |
Underwritten public offering | ||
BASIS OF PRESENTATION [Line Items] | ||
Number of shares issued | 6,052,631 | |
Public offering price | $ 9.50 | |
Gross Proceeds from issuance of stock | $ 57.5 | |
Net proceeds from issuance of stock | $ 53.8 |
PRINCIPAL BUSINESS ACTIVITY A_3
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021USD ($)countrypatent | Mar. 31, 2020USD ($) | Dec. 31, 2020USD ($) | |
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||
Number of countries where the entity's flagship product is marketed and distributed | country | 67 | ||
Number of patents | patent | 16 | ||
Gain (loss) on foreign currency transactions | $ (1,306,000) | $ (668,000) | |
Allowance for doubtful accounts | 65,000 | $ 47,000 | |
Inventory, Finished Goods, Gross | 1,622,401 | 1,164,635 | |
Inventory, Work in Process, Gross | 1,176,067 | 1,222,062 | |
Inventory, Raw Materials, Gross | 309,733 | 287,102 | |
Advertising expense | 154,000 | 31,500 | |
Cost of revenue | 2,751,444 | 2,384,842 | |
Cargo and Freight | |||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||
Cost of revenue | $ 63,000 | $ 133,000 | |
Accounts Receivable | |||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||
Concentration Risk, Percentage | 10.00% | ||
Accounts Receivable | One Distributor | |||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||
Concentration Risk, Percentage | 21.00% | ||
Sales Revenue, Net | |||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||
Concentration Risk, Percentage | 10.00% | ||
Sales Revenue, Net | One Distributor | |||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||
Concentration Risk, Percentage | 11.00% |
STOCKHOLDERS' EQUITY - Stock op
STOCKHOLDERS' EQUITY - Stock option activity (Details) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2020 | |
Shares | ||
Outstanding | 5,165,204 | |
Granted | 65,880 | |
Forfeited | (47,832) | |
Exercised | (17,031) | |
Outstanding | 5,166,221 | 5,165,204 |
Weighted Average Exercise Price per Share | ||
Outstanding | $ 6.36 | |
Granted | 8.66 | |
Forfeited | 6.25 | |
Exercised | 5.13 | |
Outstanding | $ 6.39 | $ 6.36 |
Weighted Average Remaining Contractual Life (Years) | ||
Outstanding | 7 years 3 months 3 days | |
Granted | 9 years 8 months 12 days | |
Forfeited | 0 years | |
Expired | 0 years | |
Exercised | 0 years | |
Outstanding | 7 years 10 days |
STOCKHOLDERS' EQUITY - Intrinsi
STOCKHOLDERS' EQUITY - Intrinsic value (Details) | 3 Months Ended |
Mar. 31, 2021USD ($)$ / sharesshares | |
Options Exercisable | |
Number Exercisable at March 31, 2021 | shares | 3,677,482 |
Weighted Average Exercise Price | $ 6.26 |
Aggregate Intrinsic Value | $ | $ 9,179,984 |
$2.65 - $14.50 | |
Options Outstanding | |
Range of Exercise Price, Lower Range Limit | $ 2.65 |
Range of Exercise Price, Upper Range Limit | $ 14.50 |
Number Outstanding at March 31, 2021 | shares | 5,166,221 |
Weighted Average Exercise Price | $ 6.39 |
Weighted Average Remaining Life (Years) | 7 years 10 days |
Aggregate Intrinsic Value | $ | $ 12,154,188 |
STOCKHOLDERS' EQUITY - Non-vest
STOCKHOLDERS' EQUITY - Non-vested options (Details) | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Shares | |
Non-vested, December 31, 2020 | shares | 1,998,117 |
Granted | shares | 65,880 |
Forfeited | shares | (45,906) |
Vested | shares | (529,352) |
Non-vested, March 31, 2021 | shares | 1,488,739 |
Weighted Average Grant Date Fair Value | |
Non-vested, December 31, 2020 | $ / shares | $ 4.12 |
Granted | $ / shares | 5.82 |
Forfeited | $ / shares | 3.83 |
Vested | $ / shares | 4.11 |
Non-vested, March 31, 2021 | $ / shares | $ 4.10 |
STOCKHOLDERS' EQUITY - Restrict
STOCKHOLDERS' EQUITY - Restricted stock unit (Details) - Restricted stock | 3 Months Ended |
Mar. 31, 2021USD ($)shares | |
Restricted Stock Units, Beginning Balance | 2,447,200 |
Restricted Stock Units, Intrinsic Value Beginning Balance | $ | $ 19,504,184 |
Restricted Stock Units, Granted | 39,000 |
Restricted Stock Units, Forfeited | (3,000) |
Restricted Stock Units, Ending Balance | 2,483,200 |
Restricted Stock Units, Intrinsic Value Ending Balance | $ | $ 21,554,176 |
Board of Directors | |
Restricted Stock Units, Beginning Balance | 277,200 |
Restricted Stock Units, Granted | 0 |
Restricted Stock Units, Forfeited | 0 |
Restricted Stock Units, Ending Balance | 277,200 |
Executive Management | |
Restricted Stock Units, Beginning Balance | 724,500 |
Restricted Stock Units, Granted | 0 |
Restricted Stock Units, Forfeited | 0 |
Restricted Stock Units, Ending Balance | 724,500 |
Other Employees | |
Restricted Stock Units, Beginning Balance | 1,445,500 |
Restricted Stock Units, Granted | 39,000 |
Restricted Stock Units, Forfeited | (3,000) |
Restricted Stock Units, Ending Balance | 1,481,500 |
STOCKHOLDERS' EQUITY - Restri_2
STOCKHOLDERS' EQUITY - Restricted stock unit activity (Details) - Restricted stock | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Shares | |
Non-vested, December 31, 2020 | shares | 173,972 |
Granted | shares | 60,000 |
Vested | shares | (61,902) |
Non-vested, March 31, 2021 | shares | 172,070 |
Weighted Average Grant Date Fair Value | |
Non-vested, December 31, 2020 | $ / shares | $ 6.52 |
Granted | $ / shares | 7.77 |
Vested | $ / shares | 6.22 |
Non-vested, March 31, 2021 | $ / shares | $ 7.06 |
STOCKHOLDERS' EQUITY - Addition
STOCKHOLDERS' EQUITY - Additional information (Details) - USD ($) | Apr. 12, 2021 | Jul. 24, 2020 | Apr. 20, 2020 | Jul. 09, 2019 | Feb. 28, 2020 | Jul. 22, 2019 | Mar. 04, 2019 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Jun. 30, 2019 | May 31, 2019 | Jul. 26, 2018 |
Stockholders Equity [Line Items] | ||||||||||||||
Number of preferred stock authorized | 5,000,000 | 5,000,000 | 5,000,000 | |||||||||||
Number of common stock authorized | 100,000,000 | 100,000,000 | 100,000,000 | 50,000,000 | ||||||||||
Number of shares issued | 4,301,869 | |||||||||||||
Aggregate registered amount for offerings | $ 150,000,000 | |||||||||||||
Average selling price | $ 6.53 | |||||||||||||
Net proceeds from issuance of stock | $ 27,200,000 | |||||||||||||
Expenses incurred | $ 49,000 | |||||||||||||
Number of option granted | 65,880 | |||||||||||||
Allocated share-based compensation expense | $ 667,000 | $ 729,000 | ||||||||||||
Exercise price per share | $ 8.68 | |||||||||||||
Expected life of the stock option | 10 years | |||||||||||||
expected dividends | 0.00% | |||||||||||||
Risk free interest rate, minimum | 0.47% | |||||||||||||
Risk free rate maximum | 1.03% | |||||||||||||
Total unrecognized compensation cost related to stock options | $ 5,300,000 | |||||||||||||
Amortized period | 35 months | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Number of Shares | 529,352 | |||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | $ 309,561 | 328,939 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 5,166,221 | 5,165,204 | ||||||||||||
Underwritten public offering | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Number of shares issued | 6,052,631 | |||||||||||||
Average selling price | $ 9.50 | |||||||||||||
Gross Proceeds from issuance of stock | $ 57,500,000 | |||||||||||||
Net proceeds from issuance of stock | $ 53,800,000 | |||||||||||||
Restricted stock | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 60,000 | |||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ 465,900 | |||||||||||||
Vesting period | 4 years | |||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | $ 54,000 | 0 | ||||||||||||
Restricted stock | First 30,000 restricted stock | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 30,000 | |||||||||||||
Restricted stock | Second 30,000 restricted stock | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 30,000 | |||||||||||||
Restricted stock | Second anniversary of the date of the grant | First 30,000 restricted stock | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Vesting percentage | 33.00% | |||||||||||||
Restricted stock | Third anniversary of the date of the grant | First 30,000 restricted stock | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Vesting percentage | 33.00% | |||||||||||||
Restricted stock | Fourth anniversary of the date of the grant | First 30,000 restricted stock | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Vesting percentage | 33.00% | |||||||||||||
March 4, 2019 Performance-Based Award [Member] | Restricted stock | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 22,220 | |||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ 179,000 | |||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | 11,000 | 9,000 | ||||||||||||
July 24,2020 Offering[Member] | Underwritten public offering | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Number of shares issued | 6,052,631 | |||||||||||||
Average selling price | $ 9.50 | |||||||||||||
Gross Proceeds from issuance of stock | $ 57,500,000 | |||||||||||||
Net proceeds from issuance of stock | $ 53,800,000 | |||||||||||||
July 22, 2019 Performance-Based Award [Member] | Restricted stock | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 180,300 | |||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ 1,300,000 | |||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | 103,000 | 103,000 | ||||||||||||
February 28 2020 Performance Based Award [Member] | Restricted stock | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 168,100 | |||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ 1,014,000 | |||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | $ 274,000 | $ 366,000 | ||||||||||||
Jefferies LLC and B. Riley FBR, Inc [Member] | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Number of shares issued | 4,110,625 | 191,244 | ||||||||||||
aggregate offering price | $ 50,000,000 | $ 25 | ||||||||||||
Average selling price | $ 6.64 | $ 4.11 | ||||||||||||
Net proceeds from issuance of stock | $ 26,500,000 | $ 762,000 | ||||||||||||
Commission rate (as a percent) | 3.00% | |||||||||||||
Exercise Price Ranging From 5.68 To 6.57 [Member] | Maximum | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Exercise price per share | $ 11.39 | |||||||||||||
Expected volatility | 60.70% | |||||||||||||
Exercise Price Ranging From 5.68 To 6.57 [Member] | Minimum | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Exercise price per share | $ 8.23 | |||||||||||||
Subsequent event | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Number of option granted | 1,323,400 |
REVENUE - Revenue by customer t
REVENUE - Revenue by customer type and geographic area (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Product sales: | ||
Total revenue | $ 10,598,847 | $ 8,707,310 |
Product | ||
Product sales: | ||
Total revenue | 10,143,356 | 8,155,969 |
Grant | ||
Product sales: | ||
Total revenue | 455,491 | 551,341 |
United States | Product | ||
Product sales: | ||
Total revenue | 303,650 | 0 |
United States | Grant | ||
Product sales: | ||
Total revenue | 455,491 | 551,341 |
Germany | Product | ||
Product sales: | ||
Total revenue | 5,896,192 | 4,913,588 |
All other countries | Product | ||
Product sales: | ||
Total revenue | 3,943,514 | 3,242,381 |
Direct | ||
Product sales: | ||
Total revenue | 7,017,225 | 6,409,394 |
Direct | Product | ||
Product sales: | ||
Total revenue | 7,017,225 | 6,409,394 |
Direct | United States | Product | ||
Product sales: | ||
Total revenue | 0 | |
Direct | United States | Grant | ||
Product sales: | ||
Total revenue | 0 | |
Direct | Germany | Product | ||
Product sales: | ||
Total revenue | 5,896,192 | 4,913,588 |
Direct | All other countries | Product | ||
Product sales: | ||
Total revenue | 1,121,033 | 1,495,806 |
Distributors/Strategic Partners | ||
Product sales: | ||
Total revenue | 3,126,131 | 1,746,575 |
Distributors/Strategic Partners | Product | ||
Product sales: | ||
Total revenue | 3,126,131 | 1,746,575 |
Distributors/Strategic Partners | United States | Product | ||
Product sales: | ||
Total revenue | 303,650 | 0 |
Distributors/Strategic Partners | United States | Grant | ||
Product sales: | ||
Total revenue | 0 | |
Distributors/Strategic Partners | Germany | Product | ||
Product sales: | ||
Total revenue | 0 | |
Distributors/Strategic Partners | All other countries | Product | ||
Product sales: | ||
Total revenue | 2,822,481 | 1,746,575 |
United States Government Agencies | ||
Product sales: | ||
Total revenue | 455,491 | 551,341 |
United States Government Agencies | Product | ||
Product sales: | ||
Total revenue | 0 | |
United States Government Agencies | United States | Product | ||
Product sales: | ||
Total revenue | 0 | |
United States Government Agencies | United States | Grant | ||
Product sales: | ||
Total revenue | $ 455,491 | 551,341 |
United States Government Agencies | Germany | Product | ||
Product sales: | ||
Total revenue | 0 | |
United States Government Agencies | All other countries | Product | ||
Product sales: | ||
Total revenue | $ 0 |
REVENUE - Receivables and contr
REVENUE - Receivables and contract liabilities (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
REVENUE | ||
Receivables, which are included in grants and accounts receivable | $ 2,759,368 | $ 2,996,679 |
Contract liabilities, which are included in accrued expenses and other current liabilities | $ 1,313,239 | $ 1,014,652 |
REVENUE - Additional informatio
REVENUE - Additional information (Details) | 3 Months Ended |
Mar. 31, 2021segment | |
Number of primary revenue streams | 2 |
Maximum | |
Term of customer contracts | 5 years |
Minimum | |
Term of customer contracts | 1 year |
LONG-TERM DEBT, NET - Additiona
LONG-TERM DEBT, NET - Additional information (Details) - USD ($) | Dec. 04, 2020 | Jul. 31, 2019 | Mar. 31, 2021 | Mar. 29, 2018 | Jun. 30, 2016 |
Non-refundable fee percent | 2.50% | ||||
Average selling price | $ 6.53 | ||||
Western Alliance Bank | |||||
Debt Instrument, Face Amount | $ 15,000,000 | $ 10,000,000 | |||
Repayments of debt | $ 15,000,000 | ||||
Debt Issuance Costs, Net | $ 45,000 | ||||
Long-term Debt | 375,000 | ||||
Western Alliance Bank | Closing Fee | |||||
Debt Issuance Costs, Net | $ 75,000 | ||||
Western Alliance Bank | New Term Loan | |||||
Debt Instrument, Face Amount | $ 15,000,000 | ||||
Rate of interest added to reference rate as per debt agreement | 1.25% | ||||
Western Alliance Bank | Term A Loan | |||||
Debt Instrument, Face Amount | 10,000,000 | $ 5,000,000 | |||
Western Alliance Bank | Term B Loan | |||||
Debt Instrument, Face Amount | $ 5,000,000 | ||||
Repayments of debt | $ 5,000,000 | ||||
Long-term Debt | $ 15 | ||||
Western Alliance Bank | 2018 Success Fee Letter | |||||
Percentage Of Success Fee | 6.37% | ||||
Average selling price | $ 7.05 | ||||
Number of days for stock price threshold set in success fee letter | 5 days | ||||
Western Alliance Bank | 2018 Success Fee Letter | Minimum | |||||
Percentage of Closing Price on Common Stock | 26.13% | ||||
Western Alliance Bank | 2018 Success Fee Letter | Maximum | |||||
Percentage of Closing Price on Common Stock | 70.00% |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) - USD ($) | Aug. 11, 2003 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Commitments and Contingencies Disclosure [Line Items] | ||||||
Company's maximum potential exposure | $ 89,000 | |||||
Initial term (in years) | 3 years | |||||
Term of License Agreement | 18 years | |||||
Customs examination | ||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||
Import Tax Rate Based On The Code Utilized By The Company | 0.00% | |||||
Import Tax Rate Based On The Code Suggested By Customs Authorities | 1.70% | |||||
Company's maximum potential exposure | $ 371,000 | $ 229,000 | $ 132,000 | |||
Loss contingency expense | $ 821,000 | |||||
Royalty Agreements [Member] | ||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||
Future royalty payment percentage on gross revenue | 3.00% | |||||
Royalty cost | $ 301,000 | $ 242,000 | ||||
Equity investment by an existing investor | $ 4,000,000 | |||||
License Agreement [Member] | ||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||
Royalty rate, lower limit | 2.50% | |||||
Royalty rate, upper limit | 5.00% | |||||
Royalty cost | $ 501,000 | $ 404,000 |
LEASES - ROU and Lease liabilit
LEASES - ROU and Lease liability (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
LEASES | ||
Right of use asset | $ 923,960 | $ 1,029,123 |
Total lease liability | 923,960 | 1,029,123 |
Less current portion | (462,896) | (447,485) |
Lease liability, net of current portion | $ 461,064 | $ 581,638 |
LEASES - Maturities of Lease li
LEASES - Maturities of Lease liabilities (Details) | Mar. 31, 2021USD ($) |
LEASES | |
2022 | $ 462,896 |
2023 | 145,153 |
2024 | 82,503 |
2025 | 90,386 |
2026 | 99,021 |
Thereafter | 44,001 |
Total | $ 923,960 |
LEASES - Additional Information
LEASES - Additional Information (Details) | May 31, 2022USD ($) | Apr. 28, 2021USD ($) | Apr. 01, 2021USD ($) | Mar. 31, 2021USD ($)item | Mar. 31, 2021USD ($)item | Mar. 31, 2020USD ($) | Apr. 30, 2021USD ($) | Jan. 31, 2021ft² | Dec. 31, 2020USD ($) | May 01, 2020ft² |
Lessee, Operating Lease, Discount Rate | 9.16% | 9.16% | ||||||||
Operating Lease, Payments | $ 230,865 | $ 234,000 | ||||||||
Operating Lease, Weighted Average Remaining Lease Term | 4 years | 4 years | 0 years | |||||||
Right of use asset | $ 923,960 | $ 923,960 | $ 1,029,123 | |||||||
Operating lease lability | $ 923,960 | $ 923,960 | 1,029,123 | |||||||
Twentieth Amendment To lease | ||||||||||
Operating Leases, Rent Expense, Net | $ 11,000 | $ 35,000 | ||||||||
Additional Operating Leases Rent Expense Net | 30,000 | |||||||||
Operating lease base rent for remaining space | $ 20,000 | |||||||||
Security deposit | $ 150,000 | $ 54,000 | ||||||||
CytoSorbents Medical, Inc | ||||||||||
Lessee, Operating Lease, Discount Rate | 9.80% | |||||||||
Number of times lease renewal options available | item | 2 | 2 | ||||||||
Renewal term | 5 years | 5 years | ||||||||
Remaining lease term | 15 years 6 months | 15 years 6 months | ||||||||
Annual rent expense increment rate | 2.75% | |||||||||
Rent abatement term | 6 months | |||||||||
Percentage of total building space occupied | 92.30% | 92.30% | ||||||||
Allowance for building improvement | $ 1,455,000 | $ 1,455,000 | ||||||||
Right of use asset | $ 11,600,000 | |||||||||
Operating lease lability | 11,600,000 | |||||||||
CytoSorbents Europe GmbH | ||||||||||
Area of Land | ft² | 1,068 | |||||||||
Operating Leases, Rent Expense, Net | 7,784 | |||||||||
Right of use asset | 594,000 | |||||||||
Operating lease lability | $ 594,000 | |||||||||
Lease term | 5 years | |||||||||
Other costs | $ 239 | |||||||||
Letter of credit | CytoSorbents Medical, Inc | ||||||||||
Security Amount | $ 1,334,000 | |||||||||
Initial early term | CytoSorbents Medical, Inc | ||||||||||
Operating Leases, Rent Expense, Net | 25,208 | |||||||||
Early term | CytoSorbents Medical, Inc | ||||||||||
Operating Leases, Rent Expense, Net | 88,254 | |||||||||
First year of remaining lease term | CytoSorbents Medical, Inc | ||||||||||
Operating Leases, Rent Expense, Net | $ 111,171 | |||||||||
United States | ||||||||||
Area of Land | ft² | 20,821 | |||||||||
Operating Leases, Rent Expense, Net | 34,000 | |||||||||
Additional Operating Leases Rent Expense Net | 30,000 | |||||||||
Germany | ||||||||||
Operating Leases, Rent Expense, Net | 9,000 | |||||||||
Additional Operating Leases Rent Expense Net | $ 2,900 |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Stock Options and Warrants | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 7,821,000 | 7,891,000 |
SUBSEQUENT EVENTS - Additional
SUBSEQUENT EVENTS - Additional Information (Details) - USD ($) | May 31, 2022 | Apr. 28, 2021 | Apr. 12, 2021 | Mar. 31, 2021 | Apr. 19, 2021 | Dec. 31, 2020 |
SUBSEQUENT EVENTS [Line Items] | ||||||
Number of option granted | 65,880 | |||||
Exercise price | $ 8.66 | |||||
Subsequent event | ||||||
SUBSEQUENT EVENTS [Line Items] | ||||||
Number of option granted | 1,323,400 | |||||
Grant date fair value | $ 7,111,566 | |||||
Phase II Sequential Award | Subsequent event | ||||||
SUBSEQUENT EVENTS [Line Items] | ||||||
Amount of USAMRAAA award granted to company | $ 1,499,987 | |||||
Executive Officers | Subsequent event | ||||||
SUBSEQUENT EVENTS [Line Items] | ||||||
Number of option granted | 350,450 | |||||
Exercise price | $ 8.99 | |||||
Executive Officers | Restricted stock | Subsequent event | ||||||
SUBSEQUENT EVENTS [Line Items] | ||||||
Number of option granted | 235,765 | |||||
Board of Directors | Subsequent event | ||||||
SUBSEQUENT EVENTS [Line Items] | ||||||
Number of option granted | 86,250 | |||||
Exercise price | $ 8.99 | |||||
Twentieth Amendment To lease | ||||||
SUBSEQUENT EVENTS [Line Items] | ||||||
Operating Leases, Rent Expense, Net | $ 11,000 | $ 35,000 | ||||
Additional Operating Leases Rent Expense Net | 30,000 | |||||
Operating lease base rent for remaining space | 20,000 | |||||
Security deposit | 150,000 | $ 54,000 | ||||
Twentieth Amendment To lease | Forecast | ||||||
SUBSEQUENT EVENTS [Line Items] | ||||||
Operating lease base rent for remaining space | $ 20,000 | |||||
Twentieth Amendment To lease | Subsequent event | ||||||
SUBSEQUENT EVENTS [Line Items] | ||||||
Operating Leases, Rent Expense, Net | 35,000 | |||||
Security deposit | $ 150,000 |