Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 09, 2022 | Jun. 30, 2021 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Entity File Number | 001-36792 | ||
ICFR Auditor Attestation Flag | true | ||
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, $0.001 par value | ||
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 | 43,505,948 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001175151 | ||
Amendment Flag | false | ||
Entity Public Float | $ 263,355,000 | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | No | ||
Auditor Name | WithumSmith+Brown, PC | ||
Auditor Firm ID | 100 | ||
Auditor Location | East Brunswick, New Jersey |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current Assets: | ||
Cash and cash equivalents | $ 52,137,707 | $ 71,421,601 |
Grants and accounts receivable, net of allowance for doubtful accounts of $60,539 and $46,851 at December 31, 2021 and 2020, respectively | 4,523,430 | 5,159,275 |
Inventories | 4,766,098 | 2,673,799 |
Prepaid expenses and other current assets | 2,871,655 | 3,198,460 |
Total current assets | 64,298,890 | 82,453,135 |
Property and equipment - net | 5,150,886 | 2,119,927 |
Restricted cash | 1,687,459 | 0 |
Right of use asset | 13,423,472 | 1,029,123 |
Other assets | 4,958,575 | 4,348,286 |
Total Assets | 89,519,282 | 89,950,471 |
Current Liabilities: | ||
Accounts payable | 2,805,235 | 1,835,082 |
Accrued expenses and other current liabilities | 10,314,341 | 7,870,687 |
Lease liability - current portion | 570,566 | 447,485 |
Total current liabilities | 13,690,142 | 10,153,254 |
Lease liability, net of current portion | 13,250,943 | 581,638 |
Total liabilities | 26,941,085 | 10,734,892 |
Commitments and Contingencies (Note 6) | ||
Stockholders' Equity: | ||
Preferred Stock, Par Value $0.001, 5,000,000 shares authorized; No shares issued and outstanding at December 31, 2021 and 2020 | 0 | 0 |
Common Stock, Par Value $0.001, 100,000,000 shares authorized; 43,478,487 and 43,221,999 shares issued and outstanding at December 31, 2021 and 2020, respectively | 43,478 | 43,222 |
Additional paid-in capital | 283,194,429 | 277,533,082 |
Accumulated other comprehensive income (loss) | 525,585 | (1,734,078) |
Accumulated deficit | (221,185,295) | (196,626,647) |
Total stockholders' equity | 62,578,197 | 79,215,579 |
Total Liabilities and Stockholders' Equity | $ 89,519,282 | $ 89,950,471 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
CONSOLIDATED BALANCE SHEETS | ||
Allowance for doubtful accounts | $ 60,539 | $ 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 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common Stock, Par Value | $ 0.001 | $ 0.001 |
Number of common stock authorized | 100,000,000 | 100,000,000 |
Common Stock, shares issued | 43,478,487 | 43,221,999 |
Common Stock, shares outstanding | 43,478,487 | 43,221,999 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue: | |||
Total revenue | $ 43,165,527 | $ 41,004,601 | $ 24,949,473 |
Cost of revenue | 11,047,350 | 11,052,409 | 7,363,919 |
Gross profit | 32,118,177 | 29,952,192 | 17,585,554 |
Operating expenses: | |||
Research and development | 16,380,930 | 8,810,561 | 12,091,797 |
Legal, financial and other consulting | 2,731,515 | 3,048,242 | 2,462,151 |
Selling, general and administrative | 35,750,477 | 28,463,723 | 22,005,670 |
Total operating expenses | 54,862,922 | 40,322,526 | 36,559,618 |
Loss from operations | (22,744,745) | (10,370,334) | (18,974,064) |
Other income (expense): | |||
Interest (expense), net | 28,007 | (1,201,067) | (1,033,661) |
Gain/(loss) on foreign currency transactions | (2,577,913) | 2,607,139 | (350,365) |
Total other income (expense), net | (2,549,906) | 1,406,072 | (1,384,026) |
Loss before benefit from income taxes | (25,294,651) | (8,964,262) | (20,358,090) |
Benefit from income taxes | 736,003 | 1,127,074 | 1,092,446 |
Net loss attributable to common shareholders | $ (24,558,648) | $ (7,837,188) | $ (19,265,644) |
Basic net loss per common share | $ (0.57) | $ (0.20) | $ (0.60) |
Diluted net loss per common share | $ (0.57) | $ (0.20) | $ (0.60) |
Weighted average number of shares of common stock outstanding, basic | 43,359,186 | 38,818,990 | 32,255,253 |
Weighted average number of shares of common stock outstanding, diluted | 43,359,186 | 38,818,990 | 32,255,253 |
Comprehensive loss: | |||
Net loss | $ (24,558,648) | $ (7,837,188) | $ (19,265,644) |
Other comprehensive income (loss): | |||
Currency translation adjustment | 2,259,663 | (2,260,056) | 237,803 |
Comprehensive loss | (22,298,985) | (10,097,244) | (19,027,841) |
Product | |||
Revenue: | |||
Total revenue | 40,108,567 | 39,452,502 | 22,765,854 |
Cyto Sorb Sales | |||
Revenue: | |||
Total revenue | 39,996,700 | 39,342,102 | 22,545,754 |
Other Sales | |||
Revenue: | |||
Total revenue | 111,867 | 110,400 | 220,100 |
Grant | |||
Revenue: | |||
Total revenue | $ 3,056,960 | $ 1,552,099 | $ 2,183,619 |
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, 2018 | $ 31,774 | $ 186,138,466 | $ 288,175 | $ (169,523,815) | $ 16,934,600 |
Balance (in shares) at Dec. 31, 2018 | 31,774,139 | ||||
Stock-based compensation - employees, consultants and directors | $ 0 | 1,666,024 | 0 | 0 | 1,666,024 |
Issuance of common stock - offerings, net of fees incurred | $ 192 | 673,461 | 0 | 0 | 673,653 |
Issuance of common stock - offerings, net of fees incurred (in shares) | 191,244 | ||||
Issuance of restricted stock options | $ 84 | 663,284 | 0 | 0 | 663,368 |
Issuance of restricted stock options (in shares) | 84,249 | ||||
Proceeds from exercise of warrants | $ 361 | 1,768,130 | 0 | 0 | 1,768,491 |
Proceeds from exercise of warrants (in shares) | 360,358 | ||||
Cashless exercise of warrants | $ 9 | (9) | 0 | 0 | 0 |
Cashless exercise of warrants (in shares) | 9,029 | ||||
Proceeds from exercise of stock options | $ 174 | 739,573 | 0 | 0 | 739,747 |
Proceeds from exercise of stock options (in shares) | 173,734 | ||||
Cashless exercise of stock options | $ 22 | (22) | 0 | 0 | 0 |
Cashless exercise of stock options (in shares) | 23,354 | ||||
Other comprehensive income, foreign translation adjustment | $ 0 | 0 | 237,803 | 0 | 237,803 |
Net loss | 0 | 0 | 0 | (19,265,644) | (19,265,644) |
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 | 3,513,671 | 0 | 0 | 3,513,671 |
Issuance of common stock - offerings, net of fees incurred | $ 10,162 | 80,203,846 | 0 | 0 | 80,214,008 |
Issuance of common stock - offerings, net of fees incurred (in shares) | 10,163,256 | ||||
Issuance of restricted stock options | $ 88 | 657,692 | 0 | 0 | 657,780 |
Issuance of restricted stock options (in shares) | 87,728 | ||||
Proceeds from exercise of warrants | $ 342 | 1,508,980 | 0 | 0 | 1,509,322 |
Proceeds from exercise of warrants (in shares) | 341,507 | ||||
Cashless exercise of stock options | $ 14 | (14) | 0 | 0 | 0 |
Cashless exercise of stock options (in shares) | 13,401 | ||||
Other comprehensive income, foreign translation adjustment | $ 0 | 0 | (2,260,056) | 0 | (2,260,056) |
Net loss | 0 | 0 | 0 | (7,837,188) | (7,837,188) |
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 | 4,020,819 | 0 | 0 | 4,020,819 |
Issuance of common stock - offerings, net of fees incurred | 0 | (90,000) | 0 | 0 | $ (90,000) |
Issuance of common stock - offerings, net of fees incurred (in shares) | 4,301,869 | ||||
Issuance of restricted stock options | $ 107 | 928,310 | 0 | 0 | $ 928,417 |
Issuance of restricted stock options (in shares) | 106,662 | ||||
Proceeds from exercise of stock options | $ 139 | 805,060 | 0 | 0 | 805,199 |
Proceeds from exercise of stock options (in shares) | 139,102 | ||||
Cashless exercise of stock options | $ 10 | (2,842) | 0 | 0 | (2,832) |
Cashless exercise of stock options (in shares) | 10,724 | ||||
Other comprehensive income, foreign translation adjustment | $ 0 | 0 | 2,259,663 | 0 | 2,259,663 |
Net loss | 0 | 0 | 0 | (24,558,648) | (24,558,648) |
Balance at Dec. 31, 2021 | $ 43,478 | $ 283,194,429 | $ 525,585 | $ (221,185,295) | $ 62,578,197 |
Balance (in shares) at Dec. 31, 2021 | 43,478,487 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | |||
Net loss | $ (24,558,648) | $ (7,837,188) | $ (19,265,644) |
Adjustments to reconcile net loss to net cash used by operating activities: | |||
Non-cash compensation | 2,183,317 | 1,193,949 | 1,173,743 |
Depreciation and amortization | 731,578 | 660,788 | 581,532 |
Amortization of right of use asset | 398,035 | ||
Bad debt expense (recovery) | (512) | (102,310) | 72,429 |
Foreign currency transaction (gains) losses | 2,577,913 | (2,607,139) | 350,365 |
Stock-based compensation | 4,020,819 | 3,513,671 | 1,666,024 |
Amortization of loan acquisition costs | 322,812 | 115,206 | |
Changes in operating assets and liabilities: | |||
Grants and accounts receivable | 420,578 | (326,860) | (642,171) |
Inventories | (2,350,547) | (461,512) | (1,284,848) |
Prepaid expenses and other current assets | 280,915 | (1,076,849) | (953,888) |
Other assets | (135,857) | 0 | 4,030 |
Accounts payable and accrued expenses | 2,426,810 | 1,107,352 | 1,424,440 |
Net cash used by operating activities | (14,005,599) | (5,613,286) | (16,758,782) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (3,641,248) | (708,395) | (698,165) |
Patent costs | (640,013) | (967,823) | (821,952) |
Net cash used by investing activities | (4,281,261) | (1,676,218) | (1,520,117) |
Cash flows from financing activities: | |||
Proceeds from long-term debt | 1,410,900 | 5,000,000 | |
Repayment of long-term debt | (16,410,900) | 0 | |
Final fee on long-term debt | (375,000) | 0 | |
Payment of loan acquisition costs | 0 | (4,212) | |
Equity contributions - net of fees incurred | (90,000) | 80,214,008 | 673,653 |
Proceeds from exercise of stock options | 805,199 | 1,509,322 | 739,747 |
Proceeds from exercise of warrants | 0 | 1,768,491 | |
Net cash provided by financing activities | 715,199 | 66,348,330 | 8,177,679 |
Effect of exchange rates on cash | (24,774) | 130,357 | (35,199) |
Net change in cash and cash equivalents | (17,596,435) | 59,189,183 | (10,136,419) |
Cash and cash equivalents at beginning of year | 71,421,601 | 12,232,418 | 22,368,837 |
Cash and cash equivalents at end of year | 53,825,166 | 71,421,601 | 12,232,418 |
Supplemental disclosure of cash flow information: | |||
Cash paid during the year for interest | 1,127,647 | 1,059,541 | |
Supplemental disclosure of non-cash financing activities: | |||
Settlement of accrued bonuses with restricted stock units | $ 928,417 | $ 657,780 | $ 425,639 |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 12 Months Ended |
Dec. 31, 2021 | |
BASIS OF PRESENTATION | |
BASIS OF PRESENTATION | 1. BASIS OF PRESENTATION: The accompanying consolidated financial statements include the results of CytoSorbents Corporation (the “Parent”), CytoSorbents Medical Inc., its wholly-owned operating subsidiary (the “Subsidiary”), and CytoSorbents Europe GmbH, its wholly-owned European subsidiary (the “European Subsidiary”). 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. These entities are collectively referred to as “the Company”. In years prior to December 31, 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 11. As of December 31, 2021, the Company’s cash, cash equivalents and restricted cash balances were approximately $53.8 million, which the Company expects will fund the Company’s operations well beyond twelve months from the issuance of these financial statements. 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 | 12 Months Ended |
Dec. 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 the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. 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 the Company’s 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 more than 70 countries around the world, as a safe and effective extracorporeal cytokine absorber, designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in critical illnesses that may result in massive inflammation, organ failure and patient death. 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 that can lead to post-operative complications, including multiple organ failure. In January 2020, CytoSorb received EU CE Mark label expansion to include the removal of ticagrelor during cardiopulmonary bypass in patients undergoing cardiothoracic surgery. In May 2020, CytoSorb also received EU CE Mark label expansion to include rivaroxaban removal for the same indication. In April 2020, CytoSorb received United States Food and Drug Administration (“FDA”) Emergency Use Authorization (“EUA”) of CytoSorb for use in adult critically-ill COVID-19 patients with imminent or confirmed respiratory 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 for its DrugSorb-ATR Antithrombotic Removal System 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 CytoSorbents’ technology for the removal of ticagrelor, while maintaining statutory standards of regulatory approval (e.g., 510(k), de novo In August 2021, the Company announced that it was granted a second Breakthrough Device designation for its DrugSorb-ATR Antithrombotic Removal System by the U.S. Food and Drug Administration (FDA). This Breakthrough Device designation covers the removal of the Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding during urgent cardiothoracic surgery. In October 2021, the Company also received full FDA approval of an IDE application to conduct a double-blind, randomized, controlled clinical study for up to 120 patients entitled, “Safe and Timely Antithrombotic Removal – Direct Oral Anticoagulants (STAR-D),” in the United States to support FDA marketing approval. If FDA marketing approval is obtained for either the removal of ticagrelor or direct oral anticoagulants indications, the device would be marketed as DrugSorb-ATR in the United States. The DrugSorb-ATR Antithrombotic Removal System is based on the same polymer technology as CytoSorb. 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 21 issued U.S. patents and multiple international patents, with applications pending both in the U.S. and internationally, including HemoDefend, ContrastSorb, DrugSorb, DrugSorb-ATR and others. These patents and patent applications are directed to various compositions and methods of use related to the Company’s blood purification technologies and are expected to expire between 2022 and 2038, absent any patent term extensions. Management believes that any near-term expiring patents will not have a significant impact on the Company’s ongoing business. Stock Market Listing On December 17, 2014 the Company’s common stock 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 of America dollar, the foreign currency financial statements of the European subsidiary, for which the United States of America dollar is the functional currency, are included in operations. Foreign currency transaction gain (loss) included in net loss amounted to approximately $(2,578,000), $2,607,000 and $(350,000) for the years ended December 31, 2021, 2020 and 2019, respectively. The Company translates assets and liabilities of the European subsidiary, whose functional currency is their local currency, at the exchange rate in effect at the balance sheet date. The Company translates revenue and expenses at the daily average exchange rates. The Company includes accumulated net translation adjustments in accumulated other comprehensive income (loss) as a component of stockholders’ equity. Cash and Cash Equivalents The Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. The following table provides a reconciliation of cash and cash equivalents and restricted cash and cash equivalents to amounts shown in the consolidated balance sheets and consolidated statements of cash flows: December 31, 2021 2020 Cash and cash equivalents $ 52,137,707 $ 71,421,601 Restricted cash 1,687,459 — Total cash, cash equivalents and restricted cash $ 53,825,166 $ 71,421,601 Restricted Cash The Company’s total restricted cash in the amount of $1,687,459 consists of cash of $1,467,459 that the Company is obligated to maintain as collateral for the outstanding letter of credit with Bridge Bank that was provided to the landlord of the College Road facility as security and cash of $220,000 that the Company is obligated to maintain as collateral for the credit limit on the Company’s credit card account. 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 customers’ financial condition. Management reviews accounts receivable periodically to determine collectability. Balances that are determined to be uncollectible are reserved in the allowance for doubtful accounts. Inventories Inventories are valued at the lower of cost or net realizable value. Cost is determined using a first-in first-out (“FIFO”) basis. At December 31, 2021 and 2020, the Company’s inventory was comprised of finished goods, which amounted to $3,084,606 and $1,164,635, respectively, work in process which amounted to $1,322,736 and $1,222,062, respectively and raw materials which amounted to $358,756 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. 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 statements of operations in the year of disposal. Repairs and maintenance expenditures are expensed as incurred. Patents Legal costs incurred to establish 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, research consultants and costs related to clinical trials and studies are expensed when incurred. Advertising Expenses Advertising costs are charged to activities when incurred. Advertising expense amounted to approximately $615,000, $285,000 and $314,000 in 2021, 2020 and 2019, respectively, and is 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. 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 Tax Cuts and Jobs Act reduced the U.S. federal corporate tax rate from 35% to 21%. See Note 9 for the impact of the tax rate change on deferred tax assets and liabilities. The Company follows the accounting standards associated with uncertain tax provisions. The Company had no unrecognized tax benefits at December 31, 2021 or 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 tax carryforwards and Research and Development credits to an industrial company. CytoSorbents Europe GmbH, CytoSorbents Switzerland GmbH, CytoSorbents Poland Sp. z.o.o. and CytoSorbents UK Limited files an annual corporate tax return, a 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 accounting principles generally accepted in the United States of America 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 the Company’s revenues are from product sales in Germany. Substantially all of the Company’s grant and other income are from grant agencies in the United States. (See Note 3 for further information relating to the Company’s revenue.) As of December 31, 2021, one distributor accounted for approximately 12% of outstanding grants and accounts receivables. As of December 31, 2020, no agency, distributor/strategic partners or direct customer represented more than 10% of outstanding grants and accounts receivable. For the years ended December 31, 2021, 2020 and 2019 no agency, distributor/strategic partners 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 net loss per share is computed by dividing loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed using the treasury stock method on the basis of the weighted-average number of shares of common stock plus the dilutive effect of potential common shares outstanding during the period. Dilutive potential common shares include outstanding warrants, stock options and restricted shares. The computation of diluted net loss per share does not assume conversion, exercise or contingent exercise of securities that would have an anti-dilutive effect on earnings (See Note 12). 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 non-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 shipping and handling costs in cost of revenue. Total freight costs amounted to approximately $276,000, $560,000 and $476,000 for the years ended December 31, 2021, 2020 and 2019, respectively. Effect of Recent Accounting Pronouncements In November 2021, the Financial Accounting Standards Board (the “FASB”), issued Accounting Standards Update No. 2021-10 entitled “Government Assistance (Topic 832), Disclosures by Business Entities about Government Assistance” (the “ASU”). This ASU will require enhanced disclosures related to the Company’s contracts with the U.S. Government. The ASU is effective for annual periods beginning after December 15, 2021. The Company intends to implement the provisions of this ASU during the first quarter of 2022. |
REVENUE
REVENUE | 12 Months Ended |
Dec. 31, 2021 | |
REVENUE | |
REVENUE | 3. REVENUE: The following table disaggregates the Company’s revenue by customer type and geographic area for the year ended December 31, 2021: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 189,167 $ 1,500,700 $ — $ 1,689,867 Germany 21,006,432 — — 21,006,432 All other countries 5,846,256 11,566,012 — 17,412,268 Total product revenue 27,041,855 13,066,712 — 40,108,567 Grant and other income: United States — — 3,056,960 3,056,960 Total revenue $ 27,041,855 $ 13,066,712 $ 3,056,960 $ 43,165,527 The following table disaggregates the Company’s revenue by customer type and geographic area for the year ended December 31, 2020: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 1,148,300 $ 192,900 $ — $ 1,341,200 Germany 20,257,410 — — 20,257,410 All other countries 5,275,619 12,578,273 — 17,853,892 Total product revenue 26,681,329 12,771,173 — 39,452,502 Grant and other income: United States — — 1,552,099 1,552,099 Total revenue $ 26,681,329 $ 12,771,173 $ 1,552,099 $ 41,004,601 The following table disaggregates the Company’s revenue by customer type and geographic area for the year ended December 31, 2019: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 220,100 $ — $ — $ 220,100 Germany 14,396,418 — — 14,396,418 All other countries 3,147,529 5,001,807 — 8,149,336 Total product revenue 17,764,047 5,001,807 — 22,765,854 Grant and other income: United States — — 2,183,619 2,183,619 Total revenue $ 17,764,047 $ 5,001,807 $ 2,183,619 $ 24,949,473 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: December 31, 2021 December 31, 2020 Contract receivables, which are included in accounts receivable $ 3,000,708 $ 2,996,679 Contract liabilities, which are included in Accrued expenses and other current liabilities $ 2,251,177 $ 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, which amounted to $303,824 and $286,301 at December 31, 2021 and 2020, respectively, and deferred grant revenue related to the billing on fixed price contracts in excess of costs incurred, which amounted to $1,947,353 and $728,351 at December 31, 2021 and 2020, respectively. |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 12 Months Ended |
Dec. 31, 2021 | |
PROPERTY AND EQUIPMENT, NET: | |
PROPERTY AND EQUIPMENT, NET: | 4. PROPERTY AND EQUIPMENT, NET: Property and equipment - net, consist of the following: Depreciation/ Amortization December 31, 2021 2020 Period Furniture and fixtures $ 1,424,476 $ 1,081,366 7 years Equipment and computers 5,863,673 4,318,323 3 to 7 years Leasehold improvements 2,623,356 971,247 Lesser of term of lease or estimated useful life 9,911,505 6,370,936 Less accumulated depreciation and amortization 4,760,619 4,251,009 Property and Equipment, Net $ 5,150,886 $ 2,119,927 Depreciation expense for the years ended December 31, 2021, 2020 and 2019 amounted to $542,689, $553,946 and $495,728 respectively. |
OTHER ASSETS
OTHER ASSETS | 12 Months Ended |
Dec. 31, 2021 | |
OTHER ASSETS: | |
OTHER ASSETS: | 5. OTHER ASSETS: Other assets consist of the following: December 31, 2021 2020 Patent applications pending $ 2,717,701 $ 2,970,354 Patents issued 2,641,603 1,748,938 Less accumulated amortization of patents issued (657,320) (496,898) Patents, net 4,701,984 4,222,394 Security deposits 256,591 125,892 Total $ 4,958,575 $ 4,348,286 Amortization expense amounted to $160,422, $106,842 and $85,804 for the years ended December 31, 2021, 2020 and 2019, respectively. Amortization expense for the next five years will be approximately $192,000 for the year ended December 31, 2022; approximately $189,000 for the year ended December 31, 2023; approximately $189,000 for the year ended December 31, 2024; approximately $189,000 for the year ended December 31, 2025 and approximately $188,000 for the year ended December 31, 2026. |
ACCRUED EXPENSES AND OTHER CURR
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 12 Months Ended |
Dec. 31, 2021 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: | 6. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: Accrued expenses and other current liabilities consist of the following: December 31, 2021 2020 Accrued salaries and commissions $ 3,270,715 $ 2,908,320 Deferred revenue 1,947,353 728,351 Clinical studies 1,767,826 781,041 Accrued accounts payable 1,044,088 631,642 Accrued royalties 769,262 916,695 Professional fees 314,068 317,575 Customer rebates 214,119 305,852 Sales, payroll and income taxes payable 785,818 1,159,215 Travel and entertainment 88,850 24,267 Board of Director fees 71,381 62,140 Congresses 40,861 35,589 $ 10,314,341 $ 7,870,687 |
LONG-TERM DEBT
LONG-TERM DEBT | 12 Months Ended |
Dec. 31, 2021 | |
LONG-TERM DEBT: | |
LONG-TERM DEBT: | 7. LONG-TERM DEBT: 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 “Third Amendment 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, if needed. On January 19, 2022 (the “Fourth Amendment Closing Date”), the Company closed on the Fourth Amendment (the “Fourth Amendment”) of its Amended Loan and Security Agreement with Bridge Bank. Under the terms of the Amendment, the Company received a commitment from Bridge Bank to provide a new term loan of up to $15 million, if needed. The Fourth Amendment provides a tranche of term loans (the “Term C Loans") in the aggregate amount of $15 million, which are available for the Company to draw down at its sole discretion in three tranches of $5 million each at any time during the period commencing on the Fourth Amendment Date and ending on the earlier of (i) December 31, 2022 and (ii) the occurrence of an Event of Default (as defined in the Amended Loan and Security Agreement). The Term C Loans, if taken, 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%. Pursuant to the Fourth Amendment, interest on the Term C Loans is subject to an interest rate cap of 8.00%. The Fourth Amendment, together with the Amended Loan and Security Agreement, provides for a period of interest only payments on the Term C Loan until the amortization date, which is January 1, 2024. The interest-only period may be further extended through July 2024 if the Company maintains compliance with certain conditions as outlined in the Fourth Amendment. Following the interest-only period, the Company will be required to make equal monthly payments of principal and interest until maturity of the Term C Loans. The maturity date of the Term C Loan is December 1, 2025. On the Fourth Amendment Closing Date, the Company was required to pay a non-refundable closing fee of approximately $18,750, which will amortized as a monthly charge to interest expense. On the Third Amendment Closing Date, the Company paid a non-refundable closing fee of $75,000 and the total unamortized loan costs related to the Term Loans amounted to approximately $45,000. These costs were amortized and written off as a charge to interest expense. For the years ended December 31, 2021, 2020, and 2019, the Company recorded interest expense amounting to $75,000, $76,718 and $33,175, respectively related to these costs. In addition, the Amended and Restated Loan and Security Agreement required 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 Third Amendment Closing Date, the Company paid a final fee of $375,000. For the years ended December 31, 2021, 2020 and 2019 the Company recorded interest expense of $0, $246,095, and $82,031, respectively, related to accrual and payment of the final fee. 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 2022 Success Fee Letter: Pursuant to the 2022 Success Fee Letter, the Borrower will pay to the Bank a success fee equal to (i) 1% of $5 million if the Company draws down the first tranche of the Term C Loan and is payable only if the Company’s stock price equals or exceeds $8 for five five five Paycheck Protection Program: On April 13, 2020, the Company received approximately $1,411,000 in loan proceeds from the Paycheck Protection Program (the “PPP”) administered by the Small Business Administration (the “SBA”) of the United States government. This program was established under the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”). On April 29, 2020, following a reassessment of the Company’s financial and operating position, including cash on hand and access to public capital markets, the Company repaid the PPP loan. |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2021 | |
LEASES: | |
LEASES: | 8. LEASES: The Company leases its operating facilities in both the United States and Germany under operating lease agreements. In March 2021, CytoSorbents Medical Inc. entered into a lease agreement for a new operating facility at 305 College Road East, Princeton, New Jersey, which contains office, laboratory, manufacturing and warehouse space. The lease commenced on June 1, 2021. The Early Term commenced on June 1, 2021 and lasted until September 30, 2021. The lease also contains two five-year renewal options; however, the Company has determined that it is not likely that they will exercise these options. Commencing on September 30, 2021, the remaining lease term will last for 15.5 years. The lease requires monthly rental payments of $25,208 for the Initial Early Term, $88,254 for the Early Term and initial monthly payments of approximately $111,171 in the first year of the remaining term. Following the first year of the remaining term, the annual base rent will increase by approximately 2.75% annually over the remaining term. The lease also contains six months of rent abatement (months 1, 2, 3, 25, 26 and 27 of the remaining lease term). In addition to the base rent, payments of operating expenses and real estate taxes will be required. These payments are to be based on actual amounts incurred during 2021 multiplied by the Company’s share of the total building space (92.3%). The landlord will also provide an allowance of approximately $1,455,000 related to certain building improvements as outlined in the lease. In April 2021, the Company provided the landlord with a letter of credit in the amount of approximately $1,334,000 as security. The Company has determined that this lease should be treated as an operating lease in accordance with the provisions of ASC 842. On April 1, 2021, the Company recorded a Right of Use asset and related lease liability In April 2021, the Company entered into a Twentieth Amendment to Lease with the landlord at the existing Monmouth Junction facility which became 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 is 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. In September 2021, the Company extended its two operating leases for its office facility in Germany. These leases require combined base rent payments amounting to approximately $12,100 per month. The initial lease term of both leases ends August 31, 2026. In addition, the Company is obligated to monthly operating expenses of approximately $3,000 per month. Both leases have a five-year option to renew that would extend the lease term to August 31, 2031. 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. In January 2021, CytoSorbents Europe GmbH entered into a lease for 1,068 square meters of additional warehouse space. The lease commenced on April 1, 2021 and requires monthly payments of base rent of $7,784 and other costs of approximately $239 and has a term of five years. The lease also has an option to extend the lease term for an additional five-year period through March 31, 2031. The Company has determined that this lease should be treated as an operating lease in accordance with the provisions of ASC 842. On April 1, 2020, the Company recorded a Right of Use asset and related lease liability 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 all expected renewals for all periods 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 9.8%, 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: December 31, 2021 2020 Right-of-use asset $ 13,423,472 $ 1,029,123 Total lease liability $ 13,821,509 $ 1,029,123 Less current portion (570,566) (447,485) Lease liability, net of current portion $ 13,250,943 $ 581,638 The maturities of the lease liabilities are as follows as of December 31, 2021: 2022 $ 1,896,652 2023 1,266,346 2024 1,656,678 2025 1,695,677 2026 1,735,747 Thereafter 19,009,219 Total lease payments 27,260,319 Present value discount 13,438,810 Total $ 13,821,509 For the years ended December 31, 2021, 2020 and 2019, operating cash flows paid in connection with operating leases amounted to approximately $1,968,000, $937,000 and $906,000, respectively. As of December 31, 2021 and 2020 the weighted average remaining lease term was 14.3 years and 4.0 years, respectively. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2021 | |
INCOME TAXES: | |
INCOME TAXES: | 9. INCOME TAXES: The Company accounts for income taxes under FASB ASC 740 ("ASC 740"). Deferred income tax assets and liabilities are determined based upon differences between financial reporting and tax bases of assets and liabilities, which are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company’s consolidated loss before income taxes for the years ended December 31, 2021, 2020 and 2019 is as follows: Year Ended December 31, 2021 2020 2019 Domestic $ (18,829,797) $ (5,682,628) $ (11,921,799) Foreign (6,464,854) (3,281,634) (8,436,291) Total $ (25,294,651) $ (8,964,262) $ (20,358,090) The benefit from income taxes consists of the following: Year Ended December 31, 2021 2020 2019 State Tax, including sale of New Jersey losses & credits $ 736,003 $ 1,127,074 $ 1,092,446 Foreign tax provision — — — $ 736,003 $ 1,127,074 $ 1,092,446 As of December 31, 2021, the Company had federal net operating loss ("NOL") carryforwards of approximately $83.5 million, state NOL carry forwards of approximately $9.3 million, and foreign NOL carry forwards of approximately $29.9 million, which may be available to offset future taxable income, if any. The federal NOL carryforwards of $83.5 million, if not utilized, will expire between 2022 and 2037. The federal NOL carryforwards of $35.7 million generated since 2018 are subject to an 80% limitation on taxable income, do not expire and will carry forward indefinitely. The state NOL carryforwards of $9.3 million, if not utilized, will begin to expire in 2041. As of December 31, 2021, the Company had Federal and state research and development tax credit carryforwards of approximately $2.7 million and $70,000, respectively, available to reduce future tax liabilities, which will begin to expire at various dates starting in 2022. The NOL carry forwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. The NOLs may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50%, as defined under Section 382 of the Internal Revenue Code of 1986, as amended, as well as similar state tax provisions. In addition to the new provisions enacted under the Tax Cuts and Jobs Act, this could limit the amount of NOLs that the Company can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will generally be determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. U.S. Tax Reform On December 22, 2017, the United States enacted the Tax Cuts and Jobs Act ("Tax Reform Legislation"), which made significant changes to U.S. federal income tax law. The Company expected that certain aspects of the Tax Reform Legislation will positively impact the Company’s future after-tax earnings in the U.S., primarily due to the lower federal statutory tax rate. Set forth below is a discussion of certain provisions of the Tax Reform Legislation and a preliminary assessment of the effect of such provisions on the Company’s results of operations, cash flows and consolidated financial statements. Beginning January 1, 2018, the Company’s U.S. income, if any, is taxed at a 21 percent federal corporate rate. Further, the Company is required to recognize the effect of this rate change on its deferred tax assets and liabilities, and deferred tax asset valuation allowances in the period the tax rate change is enacted. The Company does not expect any material non-cash impact from this rate change, with adjustments to deferred tax balances offset by adjustments to deferred tax valuation allowances. Further, the Tax Reform Legislation provides for a one-time “deemed repatriation” of accumulated foreign earnings for the year ended December 31, 2017. The Company did not pay U.S. federal cash taxes on the deemed repatriation due to an accumulated deficit in foreign earnings for tax purposes. The Company does not expect that its future foreign earnings will be subject to U.S. federal income tax. The Global Intangible Low-Taxed Income ("GILTI") provisions of the Tax Reform Act, enacted on December 22, 2017, require the Company to include in its U.S. income tax return foreign subsidiary earnings in excess of an allowable return on the foreign subsidiary’s tangible assets. An accounting policy election is available to either account for the tax effects of GILTI in the period that is subject to such taxes or to provide deferred taxes for book and tax basis differences that upon reversal may be subject to such taxes. The Company has elected to account for the tax effects of this provision in the period that is subject to such tax. The Company concluded it was not subject to GILTI in 2019 and as such there was no impact from GILTI included in its 2019 provision. The Company does not expect to be subject to GILTI. However, in accordance with FASB guidance, the Company’s policy will be to recognize GILTI in the period it arises and it will not recognize a deferred charge with regard to GILTI. In addition, the Tax Reform Legislation provides for 100 percent bonus depreciation on tangible property expenditures through 2022. The bonus depreciation percentage is phased down from 100 percent beginning in 2023 through 2026. We do not expect this to have a material impact to the Company. Sale of Net Operating Losses (NOLs) The Company may be eligible, from time to time, to receive cash from the sale of its New Jersey Net Operating Losses and R&D tax credits under the State of New Jersey Technology Business Tax Certificate Transfer Program. The Company will receive a net cash amount of approximately $736,000 from the approved sale of the 2020 state NOL and research and development credits in the first half of 2022. The principal components of the Company’s deferred tax assets and liabilities are as follows: Year Ended December 31, 2021 2020 2019 Deferred tax assets: Net operating loss carry forward $ 27,190,654 $ 22,301,154 $ 20,843,902 Stock options 1,203,272 305,982 329,726 Research and development credit carryforward 2,687,591 2,194,211 1,720,558 Accruals and others 232,665 135,330 56,461 Lease liability 3,997,114 289,287 300,991 Gross deferred tax assets 35,311,296 25,225,964 23,251,638 Less valuation allowance (31,242,130) (24,794,474) (22,857,741) 4,069,166 431,490 393,897 Deferred tax liability: Fixed assets (4,069,166) (431,490) (393,897) Net deferred tax assets $ — $ — $ — In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. Based on this assessment, management has established a full valuation allowance against all of the deferred tax assets for each period because it is more likely than not that all of the deferred tax assets will not be realized. The increases in valuation allowance for the years ended December 31, 2021, 2020 and 2019 were $6,447,656, $1,936,732, and $4,623,931, respectively. A reconciliation of income tax (expense) benefit at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows: Year Ended December 31, 2021 2020 2019 Federal statutory rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit (2.0) (9.5) (4.4) Foreign rate differential 2.3 3.3 3.7 Permanent items (6.5) (2.0) (2.0) Rate change and true-up 11.8 17.0 8.0 Change in valuation allowance (25.5) (21.6) (22.7) R&D credit 1.7 4.4 1.8 Effective income tax rate 2.8 % 12.6 % 5.4 % |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2021 | |
COMMITMENTS AND CONTINGENCIES: | |
COMMITMENTS AND CONTINGENCIES: | 10. 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 would be better classified under a different code which has a 1.7% tax associated with 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. The German Customs Authority informed us that the Company must use the code that carries the 1.7% tax. The audit process has been completed and the authorities have issued an assessment of approximately $641,000 for the periods through December 31, 2020. This assessment was paid by the Company in October 2021. Payroll Tax Examination In December 2021, the Company was notified that its European subsidiary, CytoSorbents Europe GmbH, would be subject to an audit of their payroll tax and social cost filings for the four-year period from 2018 through 2021. The Company has determined that payroll taxes and social costs were not paid on certain employee expense reimbursements as is required by German tax rules. Accordingly, the Company has accrued approximately $598,000 as an estimate of this liability. This liability is included in accrued expenses and other current liabilities in the consolidated balance sheet as of December 31, 2021. Approximately $154,000 of this liability relates to 2021, approximately $131,000 relates to 2020, approximately $175,000 relates to 2019 and approximately $138,000 relates to 2018. The audit is on-going and is expected to be completed during the second quarter of 2022. 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. These employment agreements have automatically renewed for an additional 1 year. 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 future royalty of 3% on all gross revenues received by the Company from the sale of its CytoSorb device. For the years ended December 31, 2021, 2020 and 2019, the Company recorded royalty expenses of approximately $1,193,000, $1,172,000, and $675,000, 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 date of the agreement. For the years ended December 31, 2021, 2020 and 2019 per the terms of the license agreement, the Company recorded licensing expenses of approximately $1,988,000 $1,954,000 and $1,125,000, respectively. These expenses are included in selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2021 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | 11. 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, enabled 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. The 2018 Shelf terminated automatically upon the 2021 Shelf (as defined below) being declared effective on July 27, 2021. On July 14, 2021, the Company filed a registration statement on Form S-3 with the SEC, which was amended on July 20, 2021 and declared effective by the SEC on July 27, 2021 (as amended, the “2021 Shelf”). The 2021 Shelf 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 “Sale Agreement”) with Jefferies LLC and B. Riley FBR, Inc. (each an “Agent” and, together, the “Agents”), pursuant to which the Company could 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 Sale Agreement would have been 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 Sale Agreement (the “Amendment”) to provide for an increase in the aggregate offering amount under the Sales Agreement, such that as of April 20, 2020, the Company could offer and sell Shares having an additional aggregate offering price of up to $50 million under the Sale Agreement, as amended by the Amendment (the “Amended Sale Agreement”). Subject to the terms of the Amended Sales Agreement, the Agents were 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 was 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. 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 pursuant to the Amended Sale Agreement during the year ended December 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 related to the Amended Sale Agreement. The Company may no longer offer and sell additional shares of the Company’s common stock under the Amended Sale Agreement following the declaration of effectiveness of the 2021 Shelf on July 27, 2021. Open Market Sale Agreement with Jefferies LLC On December 30, 2021, the Company entered into an Open Market Sale Agreement (the “Sale Agreement”) with Jefferies LLC (the “Agent”), pursuant to which the Company could 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 Agent, as the Company’s sales agent. All shares of the Company’s common stock offered and sold, or to be offered and sold under the Sale Agreement would have been issued and sold pursuant to the Company’s 2021 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. Subject to the terms of the Sales Agreement, the Agent is 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 Agent 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. There were no sales pursuant to the Amended Sale Agreement during the year ended December 31, 2021. In addition, during the year ended December 31, 2021, the Company paid approximately $90,000 related to the Amended Sale Agreement. Stock Option Plans As of December 31, 2021, the Company had two Long Term Incentive Plans (the “2014 Plan” and the “2006 Plan”) to attract, retain, and provide incentives to employees, officers, directors, and consultants. The Plans generally provide for the granting of stock, stock options, stock appreciation rights, restricted shares, or any combination of the foregoing to eligible participants. A total of 13,400,000 and 2,400,000 shares of common stock are reserved for issuance under the 2014 Plan and the 2006 Plan, respectively. As of December 31, 2021, there were shares remaining to purchase approximately 6,322,000 and 237,000 units of common stock reserved under the 2014 Plan and the 2006 Plan, respectively. The 2014 and 2006 Plans as well as grants issued outside of the Plan are administered by the Compensation Committee of the Board of Directors (the “Compensation Committee”). The Compensation Committee is authorized to select from among eligible employees, directors, advisors and consultants those individuals to whom incentives are to be granted and to determine the number of shares to be subject to, and the terms and conditions of the options. The Compensation Committee is also authorized to prescribe, amend and rescind terms relating to options granted under the Plans. Generally, the interpretation and construction of any provision of the Plans or any options granted hereunder is within the discretion of the Compensation Committee. The 2014 Plan provides that options may or may not be Incentive Stock Options (ISOs) within the meaning of Section 422 of the Internal Revenue Code. Only employees of the Company are eligible to receive ISOs, while employees and non-employee directors, advisors and consultants are eligible to receive options, which are not ISOs, i.e. “Non-Qualified Options.” Because the Company has not obtained shareholder approval of the 2006 Plan, all options granted thereunder to date are “Non-Qualified Options” and until such shareholder approval is obtained, all future options issued under the 2006 Plan will also be “Non-Qualified Options.” In December 2014, the Company’s received shareholder approval authorizing the Board of Directors to implement the form, terms and provisions of the 2014 Plan. Accordingly, any options issued to employees under the 2014 Plan will be ISOs within the meaning of Section 422 of the Internal Revenue Code. Stock-based Compensation Total share-based employee, director, and consultant compensation for the years ended December 31, 2021, 2020 and 2019 amounted to approximately $4,021,000, $3,514,000, and $1,666,000, respectively. These amounts are included in selling, general, and administrative expenses on the consolidated statements of operations and comprehensive loss. The summary of the stock option activity for the years ended December 31, 2021, 2020 and 2019 is as follows: Weighted Weighted Average Average Remaining Exercise Contractual Shares per Share Life (Years) Outstanding January 1, 2019 3,658,462 $ 5.82 7.0 Granted 1,557,300 $ 7.19 9.5 Forfeited (747,671) $ 7.39 — Expired (16,320) $ 4.16 — Exercised (233,582) $ 4.09 — Outstanding, December 31, 2019 4,218,189 $ 6.16 7.0 Granted 1,579,106 $ 6.37 9.0 Forfeited (34,644) $ 7.50 — Expired (226,440) $ 5.60 — Exercised (371,007) $ 4.46 — Outstanding, December 31, 2020 5,165,204 $ 6.36 7.26 Granted 2,051,980 $ 8.78 9.30 Forfeited (138,037) $ 6.73 — Expired (21,756) $ 7.46 — Exercised (171,413) $ 5.73 — Outstanding, December 31, 2021 6,885,978 $ 7.09 7.15 The fair value of each stock option was estimated using the Black Scholes pricing model which takes the following factors into account. Current Price of the Underlying Stock and its Grant Date Expected Life Expected Risk Free Exercise Price of the Stock Volatility Expected Interest Rate Year - Ended Range Option Range Dividends Range December 31, 2019 $ 3.84 to $8.25 per share 10 years 61.9% to 74.3 % 0 % 1.40% to 2.61 % December 31, 2020 $ 5.00 - $10.58 per share 10 years 61.7% to 69.8 % 0 % 0.28% to 0.96 % December 31, 2021 $ 4.26 - $11.39 per share 10 years 58.2% to 60.7 % 0 % 0.47% to 1.39 % In addition, the Company recognizes forfeitures as they occur. The intrinsic value is calculated at the difference between the market value as of December 31, 2021 of $4.19 and the exercise price of the shares. Options Outstanding Number Weighted Weighted Range of Outstanding at Average Average Aggregate Exercise December 31, Exercise Remaining Intrinsic Price 2021 Price Life (Years) Value $2.65 - $14.50 6,885,978 $ 7.09 7.15 $ 166,383 Options Exercisable Number Weighted Exercisable at Average Aggregate December 31, Exercise Intrinsic 2021 Price Value 3,891,132 $ 6.45 $ 166,383 The summary of the status of the Company’s non-vested options for the year ended December 31, 2021 is as follows: Weighted Average Grant Date Shares Fair Value Non-vested, January 1, 2021 1,998,117 $ 4.12 Granted 2,051,980 5.26 Forfeited (138,037) 4.05 Vested (917,214) 4.34 Non-vested, December 31, 2021 2,994,846 $ 4.68 As of December 31, 2021, the Company had approximately $5,932,000 of total unrecognized compensation cost related to stock options which will, on average, be amortized over 41 months. Awards of Stock Options: On April 12, 2021, the Board of Directors granted options to purchase 1,323,400 shares of common stock to the Company’s employees which will vest upon the achievement of certain specific, predetermined milestones related to the Company’s 2021 operations. Once awarded, these options will vest in four equal tranches, the first tranche vesting on the date of the award. The grant date fair value of these unvested options amounted to approximately $7,042,000. We have recorded approximately $273,000 in stock option expense related to these options for the year ended December 31, 2021 in accordance with the determination made by the Board of Directors on March 1, 2022 On February 28, 2020, the Board of Directors granted options to purchase 1,114,325 shares of common stock to the Company’s employees which will vest upon the achievement of certain specific, predetermined milestones related to the Company’s 2020 operations. The grant date fair value of these unvested options amounted to approximately $3,883,000. On April 12, 2021, Board of Directors determined that the Company met approximately 88% of these milestones, and accordingly we have recorded $1,070,000 and $914,000 in stock option expense related to these options for the year ended December 31, 2021, and 2020, respectively. On July 22, 2019, the Board of Directors granted options to purchase 926,800 shares of common stock to the Company's employees which will vest upon the achievement of certain specific, predetermined milestones related to the Company's 2019 operations. The grant date fair value of these unvested options amounted to approximately $4,294,000. On February 18, 2020, Board of Directors determined that the Company has met 35% of these milestones, and accordingly the Company has recorded approximately $667,000 and $735,000 of stock option expense related to these options for the years ended December 31, 2021, and 2020, respectively. Change in Control-Based Awards of Restricted Stock Units: The Board of Directors has granted restricted stock units to members of the Board of Directors, to the Company’s executive officers, and to employees of the Company. These restricted stock units will only vest upon a Change in Control of the Company, as defined in the Company’s 2014 Long-Term Incentive Plan. The following table is a summary of these restricted stock units: Board of Executive Other Directors Management Employees Total Intrinsic Value December 31, 2018 277,200 724,500 1,002,300 2,004,000 Granted 2019 — — 264,500 264,500 Forfeited 2019 — (120,000) (61,750) (181,750) December 31, 2019 277,200 604,500 1,205,050 2,086,750 $ 8,033,988 Granted 2020 — 120,000 265,700 385,700 Forfeited 2020 — — (25,250) (25,250) December 31, 2020 277,200 724,500 1,445,500 2,447,200 $ 19,504,184 Granted 2021 — — 396,000 396,000 Forfeited 2021 — — (132,000) (132,000) December 31, 2021 277,200 724,500 1,709,500 2,711,200 $ 11,359,928 Due to the uncertainty over whether these restricted stock units will vest, which will only happen upon a Change in Control, no charge for these restricted stock units has been recorded in the consolidated statements of operations and comprehensive loss for the year ended December 31, 2021. Performance-Based Awards of Restricted Stock Units: Pursuant to a review of the compensation of the senior management of the Company and managements’ performance in 2018, on March 4, 2019, the Board of Directors granted 22,220 restricted stock units to certain senior managers of the Company. 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 one one 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. 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 one one Pursuant to a review of the compensation of the senior management of the Company and managements' performance in 2020, on February 28, 2020, the Board of Directors granted 168,100 restricted stock units to certain senior managers of the Company. 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 one one Pursuant to a review of the compensation of the senior management of the Company and management’s performance in 2021, on April 12, 2021, the Board of Directors granted 235,765 restricted stock units to certain senior managers of the Company. These awards were valued at approximately $2,120,000 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 one one Additionally, in 2021 certain employees were offered 91,750 restricted stock units as a condition of their employment. These awards were valued at approximately $713,868 at the date of issuance. 46,750 of these restricted stock units vest upon the earlier of a Change in Control or one third after the second anniversary of the award, one third on the third anniversary of the award, and one third on the fourth anniversary of the award. The other 45,000 of these restricted stock units vest upon the earlier of a Change in Control or four years from the date of the award. For the years ended December 31, 2021, the Company recorded a charge of approximately $178,000 related to these restricted stock unit awards. The following table outlines the restricted stock unit activity for the year ended December 31, 2021: Weighted Average Grant Date Shares Fair Value Non-vested, January 1, 2021 173,972 $ 6.52 Granted 327,515 $ 8.65 Vested (196,525) $ 7.64 Non-vested, December 31, 2021 304,962 $ 8.08 Warrants: As of December 31, 2021, the Company had no warrants outstanding. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 12 Months Ended |
Dec. 31, 2021 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | 12. NET LOSS PER SHARE: Basic net loss per share and diluted net loss per share for the years ended December 31, 2021, 2020 and 2019 have been computed by dividing the net loss attributable to common shareholders for each respective period by the weighted average number of shares outstanding during that period. All outstanding warrants and options and restricted stock awards representing approximately 9,902,000, 7,786,000, and 6,503,000 incremental shares at December 31, 2021, 2020 and 2019, respectively, have been excluded from the computation of diluted net loss per share as they are anti-dilutive. |
RETIREMENT PLAN
RETIREMENT PLAN | 12 Months Ended |
Dec. 31, 2021 | |
RETIREMENT PLAN | |
RETIREMENT PLAN | 13. RETIREMENT PLAN: In June 2014, the Company formed the CytoSorbents 401(k) Plan. The plan is a defined contribution plan as described in section 401(k) of the Internal Revenue Code (“IRC”) covering substantially all full-time employees. Employees are eligible to participate in the plan on the first day of the calendar quarter following three |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2021 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | 14. SUBSEQUENT EVENT: On January 19, 2022, the Company closed on the Fourth Amendment of its Amended Loan and Security Agreement with Bridge Bank. Under the terms of the Amendment, the Company received a commitment from Bridge Bank to provide a new term loan of up to $15 million, if needed. See Note 7. |
QUARTERLY FINANCIAL RESULTS (UN
QUARTERLY FINANCIAL RESULTS (UNAUDITED) | 12 Months Ended |
Dec. 31, 2021 | |
QUARTERLY FINANCIAL RESULTS (UNAUDITED) | |
QUARTERLY FINANCIAL RESULTS (UNAUDITED) | 15. QUARTERLY FINANCIAL RESULTS (UNAUDITED): Summarized quarterly data for 2021, 2020 and 2019 are as follows: For the Quarters Ended March 31 June 30 September 30 December 31 2021: Total revenue $ 10,598,847 $ 12,024,069 $ 9,760,416 $ 10,782,195 Gross margin 7,847,403 9,313,852 7,297,470 7,659,452 Loss from operations (2,852,191) (4,924,733) (5,406,000) (9,561,821) Net loss attributable to common stockholders (4,167,821) (4,677,530) (6,406,285) (9,307,012) Net loss per share, basic and diluted (0.10) (0.11) (0.15) (0.25) 2020 Total revenue $ 8,707,310 $ 9,794,903 $ 10,546,612 $ 11,955,776 Gross margin 6,322,468 6,545,136 7,656,230 9,428,358 Loss from operations (2,478,754) (3,297,667) (1,959,652) (2,634,264) Net loss attributable to common stockholders (3,452,779) (2,866,956) (839,729) (677,724) Net loss per share, basic and diluted (0.10) (0.08) (0.02) 0.00 2019: Total revenue $ 5,191,629 $ 6,232,526 $ 6,095,007 $ 7,430,311 Gross margin 3,453,040 4,398,160 4,398,733 5,335,621 Loss from operations (4,285,193) (3,629,997) (5,627,546) (5,431,328) Net loss attributable to common stockholders (4,883,827) (3,547,405) (6,885,061) (3,949,351) Net loss per share, basic and diluted (0.15) (0.11) (0.21) (0.13) |
PRINCIPAL BUSINESS ACTIVITY A_2
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Nature of Business | Nature of Business The Company is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. 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 the Company’s 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 more than 70 countries around the world, as a safe and effective extracorporeal cytokine absorber, designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in critical illnesses that may result in massive inflammation, organ failure and patient death. 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 that can lead to post-operative complications, including multiple organ failure. In January 2020, CytoSorb received EU CE Mark label expansion to include the removal of ticagrelor during cardiopulmonary bypass in patients undergoing cardiothoracic surgery. In May 2020, CytoSorb also received EU CE Mark label expansion to include rivaroxaban removal for the same indication. In April 2020, CytoSorb received United States Food and Drug Administration (“FDA”) Emergency Use Authorization (“EUA”) of CytoSorb for use in adult critically-ill COVID-19 patients with imminent or confirmed respiratory 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 for its DrugSorb-ATR Antithrombotic Removal System 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 CytoSorbents’ technology for the removal of ticagrelor, while maintaining statutory standards of regulatory approval (e.g., 510(k), de novo In August 2021, the Company announced that it was granted a second Breakthrough Device designation for its DrugSorb-ATR Antithrombotic Removal System by the U.S. Food and Drug Administration (FDA). This Breakthrough Device designation covers the removal of the Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding during urgent cardiothoracic surgery. In October 2021, the Company also received full FDA approval of an IDE application to conduct a double-blind, randomized, controlled clinical study for up to 120 patients entitled, “Safe and Timely Antithrombotic Removal – Direct Oral Anticoagulants (STAR-D),” in the United States to support FDA marketing approval. If FDA marketing approval is obtained for either the removal of ticagrelor or direct oral anticoagulants indications, the device would be marketed as DrugSorb-ATR in the United States. The DrugSorb-ATR Antithrombotic Removal System is based on the same polymer technology as CytoSorb. 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 21 issued U.S. patents and multiple international patents, with applications pending both in the U.S. and internationally, including HemoDefend, ContrastSorb, DrugSorb, DrugSorb-ATR and others. These patents and patent applications are directed to various compositions and methods of use related to the Company’s blood purification technologies and are expected to expire between 2022 and 2038, absent any patent term extensions. Management believes that any near-term expiring patents will not have a significant impact on the Company’s ongoing business. |
Stock Market Listing | Stock Market Listing On December 17, 2014 the Company’s common stock 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 of America dollar, the foreign currency financial statements of the European subsidiary, for which the United States of America dollar is the functional currency, are included in operations. Foreign currency transaction gain (loss) included in net loss amounted to approximately $(2,578,000), $2,607,000 and $(350,000) for the years ended December 31, 2021, 2020 and 2019, respectively. The Company translates assets and liabilities of the European subsidiary, whose functional currency is their local currency, at the exchange rate in effect at the balance sheet date. The Company translates revenue and expenses at the daily average exchange rates. The Company includes accumulated net translation adjustments in accumulated other comprehensive income (loss) as a component of stockholders’ equity. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. The following table provides a reconciliation of cash and cash equivalents and restricted cash and cash equivalents to amounts shown in the consolidated balance sheets and consolidated statements of cash flows: December 31, 2021 2020 Cash and cash equivalents $ 52,137,707 $ 71,421,601 Restricted cash 1,687,459 — Total cash, cash equivalents and restricted cash $ 53,825,166 $ 71,421,601 |
Restricted Cash | Restricted Cash The Company’s total restricted cash in the amount of $1,687,459 consists of cash of $1,467,459 that the Company is obligated to maintain as collateral for the outstanding letter of credit with Bridge Bank that was provided to the landlord of the College Road facility as security and cash of $220,000 that the Company is obligated to maintain as collateral for the credit limit on the Company’s credit card account. |
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 customers’ financial condition. Management reviews accounts receivable periodically to determine collectability. Balances that are determined to be uncollectible are reserved in the allowance for doubtful accounts. |
Inventories | Inventories Inventories are valued at the lower of cost or net realizable value. Cost is determined using a first-in first-out (“FIFO”) basis. At December 31, 2021 and 2020, the Company’s inventory was comprised of finished goods, which amounted to $3,084,606 and $1,164,635, respectively, work in process which amounted to $1,322,736 and $1,222,062, respectively and raw materials which amounted to $358,756 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. |
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 statements of operations in the year of disposal. Repairs and maintenance expenditures are expensed as incurred. |
Patents | Patents Legal costs incurred to establish 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, research consultants and costs related to clinical trials and studies are expensed when incurred. |
Advertising Expenses | Advertising Expenses Advertising costs are charged to activities when incurred. Advertising expense amounted to approximately $615,000, $285,000 and $314,000 in 2021, 2020 and 2019, respectively, and is 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. 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 Tax Cuts and Jobs Act reduced the U.S. federal corporate tax rate from 35% to 21%. See Note 9 for the impact of the tax rate change on deferred tax assets and liabilities. The Company follows the accounting standards associated with uncertain tax provisions. The Company had no unrecognized tax benefits at December 31, 2021 or 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 tax carryforwards and Research and Development credits to an industrial company. CytoSorbents Europe GmbH, CytoSorbents Switzerland GmbH, CytoSorbents Poland Sp. z.o.o. and CytoSorbents UK Limited files an annual corporate tax return, a 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 accounting principles generally accepted in the United States of America 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 the Company’s revenues are from product sales in Germany. Substantially all of the Company’s grant and other income are from grant agencies in the United States. (See Note 3 for further information relating to the Company’s revenue.) As of December 31, 2021, one distributor accounted for approximately 12% of outstanding grants and accounts receivables. As of December 31, 2020, no agency, distributor/strategic partners or direct customer represented more than 10% of outstanding grants and accounts receivable. For the years ended December 31, 2021, 2020 and 2019 no agency, distributor/strategic partners 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 net loss per share is computed by dividing loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed using the treasury stock method on the basis of the weighted-average number of shares of common stock plus the dilutive effect of potential common shares outstanding during the period. Dilutive potential common shares include outstanding warrants, stock options and restricted shares. The computation of diluted net loss per share does not assume conversion, exercise or contingent exercise of securities that would have an anti-dilutive effect on earnings (See Note 12). |
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 non-employees for acquiring, or in conjunction with selling, goods or services for equity instruments issued to consultants. |
Effects of Recent Accounting Pronouncements | Effect of Recent Accounting Pronouncements In November 2021, the Financial Accounting Standards Board (the “FASB”), issued Accounting Standards Update No. 2021-10 entitled “Government Assistance (Topic 832), Disclosures by Business Entities about Government Assistance” (the “ASU”). This ASU will require enhanced disclosures related to the Company’s contracts with the U.S. Government. The ASU is effective for annual periods beginning after December 15, 2021. The Company intends to implement the provisions of this ASU during the first quarter of 2022. |
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 shipping and handling costs in cost of revenue. Total freight costs amounted to approximately $276,000, $560,000 and $476,000 for the years ended December 31, 2021, 2020 and 2019, respectively. |
REVENUE (Tables)
REVENUE (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
REVENUE | |
Schedule of disaggregation of Revenue | The following table disaggregates the Company’s revenue by customer type and geographic area for the year ended December 31, 2021: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 189,167 $ 1,500,700 $ — $ 1,689,867 Germany 21,006,432 — — 21,006,432 All other countries 5,846,256 11,566,012 — 17,412,268 Total product revenue 27,041,855 13,066,712 — 40,108,567 Grant and other income: United States — — 3,056,960 3,056,960 Total revenue $ 27,041,855 $ 13,066,712 $ 3,056,960 $ 43,165,527 The following table disaggregates the Company’s revenue by customer type and geographic area for the year ended December 31, 2020: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 1,148,300 $ 192,900 $ — $ 1,341,200 Germany 20,257,410 — — 20,257,410 All other countries 5,275,619 12,578,273 — 17,853,892 Total product revenue 26,681,329 12,771,173 — 39,452,502 Grant and other income: United States — — 1,552,099 1,552,099 Total revenue $ 26,681,329 $ 12,771,173 $ 1,552,099 $ 41,004,601 The following table disaggregates the Company’s revenue by customer type and geographic area for the year ended December 31, 2019: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 220,100 $ — $ — $ 220,100 Germany 14,396,418 — — 14,396,418 All other countries 3,147,529 5,001,807 — 8,149,336 Total product revenue 17,764,047 5,001,807 — 22,765,854 Grant and other income: United States — — 2,183,619 2,183,619 Total revenue $ 17,764,047 $ 5,001,807 $ 2,183,619 $ 24,949,473 |
Schedule of receivables and contract liabilities from contracts with customers | December 31, 2021 December 31, 2020 Contract receivables, which are included in accounts receivable $ 3,000,708 $ 2,996,679 Contract liabilities, which are included in Accrued expenses and other current liabilities $ 2,251,177 $ 1,014,652 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
PROPERTY AND EQUIPMENT, NET: | |
Schedule of Property and Equipment, Net | Depreciation/ Amortization December 31, 2021 2020 Period Furniture and fixtures $ 1,424,476 $ 1,081,366 7 years Equipment and computers 5,863,673 4,318,323 3 to 7 years Leasehold improvements 2,623,356 971,247 Lesser of term of lease or estimated useful life 9,911,505 6,370,936 Less accumulated depreciation and amortization 4,760,619 4,251,009 Property and Equipment, Net $ 5,150,886 $ 2,119,927 |
OTHER ASSETS (Tables)
OTHER ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
OTHER ASSETS: | |
Schedule of Other Assets | December 31, 2021 2020 Patent applications pending $ 2,717,701 $ 2,970,354 Patents issued 2,641,603 1,748,938 Less accumulated amortization of patents issued (657,320) (496,898) Patents, net 4,701,984 4,222,394 Security deposits 256,591 125,892 Total $ 4,958,575 $ 4,348,286 |
ACCRUED EXPENSES AND OTHER CU_2
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: | |
Schedule of accrued expenses and other current liabilities | December 31, 2021 2020 Accrued salaries and commissions $ 3,270,715 $ 2,908,320 Deferred revenue 1,947,353 728,351 Clinical studies 1,767,826 781,041 Accrued accounts payable 1,044,088 631,642 Accrued royalties 769,262 916,695 Professional fees 314,068 317,575 Customer rebates 214,119 305,852 Sales, payroll and income taxes payable 785,818 1,159,215 Travel and entertainment 88,850 24,267 Board of Director fees 71,381 62,140 Congresses 40,861 35,589 $ 10,314,341 $ 7,870,687 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
LEASES: | |
Schedule Of Right-Of-Asset And Related Lease Liability | December 31, 2021 2020 Right-of-use asset $ 13,423,472 $ 1,029,123 Total lease liability $ 13,821,509 $ 1,029,123 Less current portion (570,566) (447,485) Lease liability, net of current portion $ 13,250,943 $ 581,638 |
Schedule of Maturities of Lease Liabilities | The maturities of the lease liabilities are as follows as of December 31, 2021: 2022 $ 1,896,652 2023 1,266,346 2024 1,656,678 2025 1,695,677 2026 1,735,747 Thereafter 19,009,219 Total lease payments 27,260,319 Present value discount 13,438,810 Total $ 13,821,509 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
INCOME TAXES: | |
Schedule of Income before Income Tax, Domestic and Foreign | Year Ended December 31, 2021 2020 2019 Domestic $ (18,829,797) $ (5,682,628) $ (11,921,799) Foreign (6,464,854) (3,281,634) (8,436,291) Total $ (25,294,651) $ (8,964,262) $ (20,358,090) |
Schedule of Components of Income Tax Expense (Benefit) | Year Ended December 31, 2021 2020 2019 State Tax, including sale of New Jersey losses & credits $ 736,003 $ 1,127,074 $ 1,092,446 Foreign tax provision — — — $ 736,003 $ 1,127,074 $ 1,092,446 |
Schedule of Deferred Tax Assets and Liabilities | Year Ended December 31, 2021 2020 2019 Deferred tax assets: Net operating loss carry forward $ 27,190,654 $ 22,301,154 $ 20,843,902 Stock options 1,203,272 305,982 329,726 Research and development credit carryforward 2,687,591 2,194,211 1,720,558 Accruals and others 232,665 135,330 56,461 Lease liability 3,997,114 289,287 300,991 Gross deferred tax assets 35,311,296 25,225,964 23,251,638 Less valuation allowance (31,242,130) (24,794,474) (22,857,741) 4,069,166 431,490 393,897 Deferred tax liability: Fixed assets (4,069,166) (431,490) (393,897) Net deferred tax assets $ — $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation | Year Ended December 31, 2021 2020 2019 Federal statutory rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit (2.0) (9.5) (4.4) Foreign rate differential 2.3 3.3 3.7 Permanent items (6.5) (2.0) (2.0) Rate change and true-up 11.8 17.0 8.0 Change in valuation allowance (25.5) (21.6) (22.7) R&D credit 1.7 4.4 1.8 Effective income tax rate 2.8 % 12.6 % 5.4 % |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
STOCKHOLDERS' EQUITY | |
Schedule Of Share Based Compensation Stock Options Activity | The summary of the stock option activity for the years ended December 31, 2021, 2020 and 2019 is as follows: Weighted Weighted Average Average Remaining Exercise Contractual Shares per Share Life (Years) Outstanding January 1, 2019 3,658,462 $ 5.82 7.0 Granted 1,557,300 $ 7.19 9.5 Forfeited (747,671) $ 7.39 — Expired (16,320) $ 4.16 — Exercised (233,582) $ 4.09 — Outstanding, December 31, 2019 4,218,189 $ 6.16 7.0 Granted 1,579,106 $ 6.37 9.0 Forfeited (34,644) $ 7.50 — Expired (226,440) $ 5.60 — Exercised (371,007) $ 4.46 — Outstanding, December 31, 2020 5,165,204 $ 6.36 7.26 Granted 2,051,980 $ 8.78 9.30 Forfeited (138,037) $ 6.73 — Expired (21,756) $ 7.46 — Exercised (171,413) $ 5.73 — Outstanding, December 31, 2021 6,885,978 $ 7.09 7.15 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | The fair value of each stock option was estimated using the Black Scholes pricing model which takes the following factors into account. Current Price of the Underlying Stock and its Grant Date Expected Life Expected Risk Free Exercise Price of the Stock Volatility Expected Interest Rate Year - Ended Range Option Range Dividends Range December 31, 2019 $ 3.84 to $8.25 per share 10 years 61.9% to 74.3 % 0 % 1.40% to 2.61 % December 31, 2020 $ 5.00 - $10.58 per share 10 years 61.7% to 69.8 % 0 % 0.28% to 0.96 % December 31, 2021 $ 4.26 - $11.39 per share 10 years 58.2% to 60.7 % 0 % 0.47% to 1.39 % |
Schedule of Share-based Compensation, Shares Authorized under Stock Option Plans, by Exercise Price Range | In addition, the Company recognizes forfeitures as they occur. The intrinsic value is calculated at the difference between the market value as of December 31, 2021 of $4.19 and the exercise price of the shares. Options Outstanding Number Weighted Weighted Range of Outstanding at Average Average Aggregate Exercise December 31, Exercise Remaining Intrinsic Price 2021 Price Life (Years) Value $2.65 - $14.50 6,885,978 $ 7.09 7.15 $ 166,383 Options Exercisable Number Weighted Exercisable at Average Aggregate December 31, Exercise Intrinsic 2021 Price Value 3,891,132 $ 6.45 $ 166,383 |
Schedule Of Non vested Share Activity | The summary of the status of the Company’s non-vested options for the year ended December 31, 2021 is as follows: Weighted Average Grant Date Shares Fair Value Non-vested, January 1, 2021 1,998,117 $ 4.12 Granted 2,051,980 5.26 Forfeited (138,037) 4.05 Vested (917,214) 4.34 Non-vested, December 31, 2021 2,994,846 $ 4.68 |
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | The following table is a summary of these restricted stock units: Board of Executive Other Directors Management Employees Total Intrinsic Value December 31, 2018 277,200 724,500 1,002,300 2,004,000 Granted 2019 — — 264,500 264,500 Forfeited 2019 — (120,000) (61,750) (181,750) December 31, 2019 277,200 604,500 1,205,050 2,086,750 $ 8,033,988 Granted 2020 — 120,000 265,700 385,700 Forfeited 2020 — — (25,250) (25,250) December 31, 2020 277,200 724,500 1,445,500 2,447,200 $ 19,504,184 Granted 2021 — — 396,000 396,000 Forfeited 2021 — — (132,000) (132,000) December 31, 2021 277,200 724,500 1,709,500 2,711,200 $ 11,359,928 |
Schedule Of Restricted Stock Unit Activity | The following table outlines the restricted stock unit activity for the year ended December 31, 2021: Weighted Average Grant Date Shares Fair Value Non-vested, January 1, 2021 173,972 $ 6.52 Granted 327,515 $ 8.65 Vested (196,525) $ 7.64 Non-vested, December 31, 2021 304,962 $ 8.08 |
QUARTERLY FINANCIAL RESULTS (_2
QUARTERLY FINANCIAL RESULTS (UNAUDITED) (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
QUARTERLY FINANCIAL RESULTS (UNAUDITED) | |
Summarized quarterly information | For the Quarters Ended March 31 June 30 September 30 December 31 2021: Total revenue $ 10,598,847 $ 12,024,069 $ 9,760,416 $ 10,782,195 Gross margin 7,847,403 9,313,852 7,297,470 7,659,452 Loss from operations (2,852,191) (4,924,733) (5,406,000) (9,561,821) Net loss attributable to common stockholders (4,167,821) (4,677,530) (6,406,285) (9,307,012) Net loss per share, basic and diluted (0.10) (0.11) (0.15) (0.25) 2020 Total revenue $ 8,707,310 $ 9,794,903 $ 10,546,612 $ 11,955,776 Gross margin 6,322,468 6,545,136 7,656,230 9,428,358 Loss from operations (2,478,754) (3,297,667) (1,959,652) (2,634,264) Net loss attributable to common stockholders (3,452,779) (2,866,956) (839,729) (677,724) Net loss per share, basic and diluted (0.10) (0.08) (0.02) 0.00 2019: Total revenue $ 5,191,629 $ 6,232,526 $ 6,095,007 $ 7,430,311 Gross margin 3,453,040 4,398,160 4,398,733 5,335,621 Loss from operations (4,285,193) (3,629,997) (5,627,546) (5,431,328) Net loss attributable to common stockholders (4,883,827) (3,547,405) (6,885,061) (3,949,351) Net loss per share, basic and diluted (0.15) (0.11) (0.21) (0.13) |
BASIS OF PRESENTATION (Details)
BASIS OF PRESENTATION (Details) - USD ($) $ / shares in Units, $ in Millions | Jul. 24, 2020 | Dec. 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 | $ 53.8 | |
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) | 12 Months Ended | ||||
Dec. 31, 2021USD ($)patentitem | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018 | Dec. 31, 2017 | |
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||||
Number of countries where the entity's flagship product is marketed and distributed | item | 70 | ||||
Number of patents | patent | 21 | ||||
Gain (loss) on foreign currency transactions | $ (2,578,000) | $ 2,607,000 | $ (350,000) | ||
Restricted cash | 1,687,459 | 0 | |||
Inventory, Finished Goods, Gross | 3,084,606 | 1,164,635 | |||
Inventory, Work in Process, Gross | 1,322,736 | 1,222,062 | |||
Inventory, Raw Materials, Gross | 358,756 | 287,102 | |||
Advertising expense | $ 615,000 | $ 285,000 | $ 314,000 | ||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 21.00% | 21.00% | ||
Unrecognized Tax Benefits | $ 0 | $ 0 | |||
Cost of revenue | 11,047,350 | 11,052,409 | $ 7,363,919 | ||
Letter of credit | |||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||||
Cash collateral | 1,467,459 | ||||
Credit Card | |||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||||
Cash collateral | 220,000 | ||||
Federal [Member] | |||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 35.00% | |||
Cargo and Freight | |||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||||
Cost of revenue | $ 276,000 | $ 560,000 | $ 476,000 | ||
Accounts Receivable | |||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||||
Concentration Risk, Percentage | 10.00% | ||||
Accounts Receivable | One Distributor/strategic partner | |||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||||
Concentration Risk, Percentage | 12.00% | ||||
Sales Revenue, Net | |||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||||
Concentration Risk, Percentage | 10.00% | 10.00% | 10.00% |
PRINCIPAL BUSINESS ACTIVITY A_4
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Cash and Cash Equivalents (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||
Cash and cash equivalents | $ 52,137,707 | $ 71,421,601 | ||
Restricted cash | 1,687,459 | |||
Total cash, cash equivalents and restricted cash | $ 53,825,166 | $ 71,421,601 | $ 12,232,418 | $ 22,368,837 |
REVENUE - Revenue by customer t
REVENUE - Revenue by customer type and geographic area (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||||||
Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Product sales: | |||||||||||||||
Total revenue | $ 10,782,195 | $ 9,760,416 | $ 12,024,069 | $ 10,598,847 | $ 11,955,776 | $ 10,546,612 | $ 9,794,903 | $ 8,707,310 | $ 7,430,311 | $ 6,095,007 | $ 6,232,526 | $ 5,191,629 | $ 43,165,527 | $ 41,004,601 | $ 24,949,473 |
Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 40,108,567 | 39,452,502 | 22,765,854 | ||||||||||||
Grant | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 3,056,960 | 1,552,099 | 2,183,619 | ||||||||||||
United States | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 1,689,867 | 1,341,200 | 220,100 | ||||||||||||
United States | Grant | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 3,056,960 | 1,552,099 | 2,183,619 | ||||||||||||
Germany | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 21,006,432 | 20,257,410 | 14,396,418 | ||||||||||||
All other countries | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 17,412,268 | 17,853,892 | 8,149,336 | ||||||||||||
Direct | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 27,041,855 | 26,681,329 | 17,764,047 | ||||||||||||
Direct | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 27,041,855 | 26,681,329 | 17,764,047 | ||||||||||||
Direct | United States | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 189,167 | 1,148,300 | 220,100 | ||||||||||||
Direct | United States | Grant | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 0 | 0 | 0 | ||||||||||||
Direct | Germany | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 21,006,432 | 20,257,410 | 14,396,418 | ||||||||||||
Direct | All other countries | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 5,846,256 | 5,275,619 | 3,147,529 | ||||||||||||
Distributors/Strategic Partners | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 13,066,712 | 12,771,173 | 5,001,807 | ||||||||||||
Distributors/Strategic Partners | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 13,066,712 | 12,771,173 | 5,001,807 | ||||||||||||
Distributors/Strategic Partners | United States | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 1,500,700 | 192,900 | 0 | ||||||||||||
Distributors/Strategic Partners | United States | Grant | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 0 | 0 | 0 | ||||||||||||
Distributors/Strategic Partners | Germany | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 0 | 0 | 0 | ||||||||||||
Distributors/Strategic Partners | All other countries | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 11,566,012 | 12,578,273 | 5,001,807 | ||||||||||||
United States Government Agencies | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 3,056,960 | 1,552,099 | 2,183,619 | ||||||||||||
United States Government Agencies | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 0 | 0 | 0 | ||||||||||||
United States Government Agencies | United States | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 0 | 0 | 0 | ||||||||||||
United States Government Agencies | United States | Grant | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 3,056,960 | 1,552,099 | 2,183,619 | ||||||||||||
United States Government Agencies | Germany | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 0 | 0 | 0 | ||||||||||||
United States Government Agencies | All other countries | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | $ 0 | $ 0 | $ 0 |
REVENUE - Receivables and contr
REVENUE - Receivables and contract liabilities (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
REVENUE | ||
Contract receivables, which are included in accounts receivable | $ 3,000,708 | $ 2,996,679 |
Contract liabilities, which are included in Accrued expenses and other current liabilities | $ 2,251,177 | $ 1,014,652 |
REVENUE - Additional informatio
REVENUE - Additional information (Details) | 12 Months Ended | |
Dec. 31, 2021USD ($)item | Dec. 31, 2020USD ($) | |
Number of primary revenue streams | item | 2 | |
Term of customer contracts | 3 years | |
Value of free of charge goods and credit rebates | $ 303,824 | $ 286,301 |
Contract liabilities net of Value of free of charge goods and credit rebates | $ 1,947,353 | $ 728,351 |
Maximum | ||
Term of customer contracts | 5 years | |
Minimum | ||
Term of customer contracts | 1 year |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 9,911,505 | $ 6,370,936 |
Less accumulated depreciation and amortization | 4,760,619 | 4,251,009 |
Property and Equipment, Net | 5,150,886 | 2,119,927 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 1,424,476 | 1,081,366 |
Property, Plant and Equipment, Useful Life | 7 years | |
Equipment and computers | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 5,863,673 | 4,318,323 |
Equipment and computers | Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 7 years | |
Equipment and computers | Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 3 years | |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 2,623,356 | $ 971,247 |
PROPERTY AND EQUIPMENT, NET - A
PROPERTY AND EQUIPMENT, NET - Additional information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
PROPERTY AND EQUIPMENT, NET: | |||
Depreciation | $ 542,689 | $ 553,946 | $ 495,728 |
OTHER ASSETS (Details)
OTHER ASSETS (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Other Assets [Line Items] | ||
Less accumulated amortization of patents issued | $ (657,320) | $ (496,898) |
Patents, net | 4,701,984 | 4,222,394 |
Security deposits | 256,591 | 125,892 |
Total | 4,958,575 | 4,348,286 |
Patent applications pending | ||
Other Assets [Line Items] | ||
Patents | 2,717,701 | 2,970,354 |
Patents issued | ||
Other Assets [Line Items] | ||
Patents | $ 2,641,603 | $ 1,748,938 |
OTHER ASSETS_ - Additional info
OTHER ASSETS: - Additional information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
OTHER ASSETS: | |||
2022 | $ 192,000 | ||
2023 | 189,000 | ||
2024 | 189,000 | ||
2025 | 189,000 | ||
2026 | 188,000 | ||
Amortization expense | $ 160,422 | $ 106,842 | $ 85,804 |
ACCRUED EXPENSES AND OTHER CU_3
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: | ||
Accrued salaries and commissions | $ 3,270,715 | $ 2,908,320 |
Deferred revenue | 1,947,353 | 728,351 |
Clinical studies | 1,767,826 | 781,041 |
Accrued accounts payable | 1,044,088 | 631,642 |
Accrued royalties | 769,262 | 916,695 |
Professional fees | 314,068 | 317,575 |
Customer rebates | 214,119 | 305,852 |
Sales, payroll and income taxes payable | 785,818 | 1,159,215 |
Travel and entertainment | 88,850 | 24,267 |
Board of Director fees | 71,381 | 62,140 |
Congresses | 40,861 | 35,589 |
Accrued Expenses And Other Current Liabilities | $ 10,314,341 | $ 7,870,687 |
LONG-TERM DEBT_ (Details)
LONG-TERM DEBT: (Details) - USD ($) | Dec. 04, 2020 | Apr. 13, 2020 | Jul. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 19, 2022 | Mar. 29, 2018 | Jun. 30, 2016 |
Non-refundable fee percent | 2.50% | ||||||||
Average selling price | $ 6.53 | ||||||||
Loan Proceeds From Paycheck Protection Program | $ 1,411,000 | ||||||||
Non refundable Closing Fee | |||||||||
Debt Issuance Costs, Net | $ 18,750 | ||||||||
Interest Expense, Debt | 75,000 | $ 76,718 | $ 33,175 | ||||||
Non refundable Final Fee | |||||||||
Interest Expense, Debt | $ 0 | $ 246,095 | $ 82,031 | ||||||
2022 Success Fee Letter | First Tranche | |||||||||
Percentage Of Success Fee | 1.00% | ||||||||
Average selling price | $ 8 | ||||||||
Number of days for stock price threshold set in success fee letter | 5 days | ||||||||
Maximum borrowing capacity | $ 5,000,000 | ||||||||
2022 Success Fee Letter | Second Tranche | |||||||||
Percentage Of Success Fee | 1.50% | ||||||||
Average selling price | $ 10 | ||||||||
Number of days for stock price threshold set in success fee letter | 5 days | ||||||||
Maximum borrowing capacity | $ 5,000,000 | ||||||||
2022 Success Fee Letter | Third Tranche | |||||||||
Percentage Of Success Fee | 2.00% | ||||||||
Average selling price | $ 12 | ||||||||
Number of days for stock price threshold set in success fee letter | 5 days | ||||||||
Maximum borrowing capacity | $ 5,000,000 | ||||||||
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 | $ 15,000,000 | $ 5,000,000 | ||||||
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 | ||||||||
Western Alliance Bank | Term B Loan | |||||||||
Debt Instrument, Face Amount | $ 5,000,000 | ||||||||
Repayments of debt | $ 5,000,000 | ||||||||
Long-term Debt | $ 15,000,000 | ||||||||
Western Alliance Bank | Term C Loan | |||||||||
Maximum borrowing capacity | $ 15,000,000 | ||||||||
Current borrowing capacity | $ 5,000,000 | ||||||||
Interest rate cap | 8.00% | ||||||||
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% |
LEASES_ - ROU and Lease liabili
LEASES: - ROU and Lease liability (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
LEASES: | ||
Right-of-use asset | $ 13,423,472 | $ 1,029,123 |
Total | 13,821,509 | 1,029,123 |
Less current portion | (570,566) | (447,485) |
Lease liability, net of current portion | $ 13,250,943 | $ 581,638 |
LEASES_ - Maturities of Lease l
LEASES: - Maturities of Lease liabilities (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
LEASES: | ||
2022 | $ 1,896,652 | |
2023 | 1,266,346 | |
2024 | 1,656,678 | |
2025 | 1,695,677 | |
2026 | 1,735,747 | |
Thereafter | 19,009,219 | |
Total lease payments | 27,260,319 | |
Present value discount | 13,438,810 | |
Total | $ 13,821,509 | $ 1,029,123 |
LEASES_ - Additional Informatio
LEASES: - Additional Information (Details) | Apr. 01, 2021USD ($) | Sep. 30, 2021USD ($) | Apr. 30, 2021USD ($) | Mar. 31, 2021USD ($)item | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Jan. 31, 2021m² |
Lessee, Operating Lease, Discount Rate | 9.80% | |||||||
Operating Lease, Payments | $ 1,968,000 | $ 937,000 | $ 906,000 | |||||
Operating Lease, Weighted Average Remaining Lease Term | 14 years 3 months 18 days | 4 years | ||||||
Security deposit | $ 256,591 | $ 125,892 | ||||||
Right of use asset | 13,423,472 | 1,029,123 | ||||||
Operating lease lability | $ 13,821,509 | 1,029,123 | ||||||
Twentieth Amendment To lease | ||||||||
Operating Lease, Expense | $ 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 | ||||||
Monthly operating expenses | 11,000 | |||||||
CytoSorbents Medical, Inc | ||||||||
Number of times lease renewal options available | item | 2 | |||||||
Renewal term | 5 years | |||||||
Rent abatement term | 6 months | |||||||
CytoSorbents Europe GmbH | ||||||||
Area of Land | m² | 1,068 | |||||||
Operating Lease, Expense | $ 7,784 | |||||||
Lease term | 5 years | |||||||
Other costs | $ 239 | |||||||
Right of use asset | 594,000 | |||||||
Operating lease lability | $ 594,000 | |||||||
United States | CytoSorbents Medical, Inc | ||||||||
Lessee, Operating Lease, Discount Rate | 9.80% | |||||||
Remaining lease term | 15 years 6 months | |||||||
Annual rent expense increment rate | 2.75% | |||||||
Percentage of total building space occupied | 92.30% | |||||||
Allowance for building improvement | $ 1,455,000 | |||||||
Right of use asset | $ 11,600,000 | |||||||
Operating lease lability | $ 11,600,000 | |||||||
United States | Letter of credit | CytoSorbents Medical, Inc | ||||||||
Security Amount | $ 1,334,000 | |||||||
United States | Initial early term | CytoSorbents Medical, Inc | ||||||||
Operating Lease, Expense | 25,208 | |||||||
United States | Early term | CytoSorbents Medical, Inc | ||||||||
Operating Lease, Expense | 88,254 | |||||||
United States | First year of remaining lease term | CytoSorbents Medical, Inc | ||||||||
Operating Lease, Expense | $ 111,171 | |||||||
Germany | ||||||||
Operating Lease, Expense | $ 12,100 | |||||||
Additional Operating Leases Rent Expense Net | $ 3,000 |
INCOME TAXES_ - Consolidated lo
INCOME TAXES: - Consolidated loss before income taxes (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
INCOME TAXES: | |||
Domestic | $ (18,829,797) | $ (5,682,628) | $ (11,921,799) |
Foreign | (6,464,854) | (3,281,634) | (8,436,291) |
Total | $ (25,294,651) | $ (8,964,262) | $ (20,358,090) |
INCOME TAXES_ - The benefit fro
INCOME TAXES: - The benefit from income taxes (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
INCOME TAXES: | |||
State Tax, including sale of New Jersey losses & credits | $ 736,003 | $ 1,127,074 | $ 1,092,446 |
Foreign tax provision | 0 | 0 | 0 |
Income Tax Expense (Benefit), Total | $ 736,003 | $ 1,127,074 | $ 1,092,446 |
INCOME TAXES_ - The principal c
INCOME TAXES: - The principal components of the Company's deferred tax assets and liabilities (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | |||
Net operating loss carryforward | $ 27,190,654 | $ 22,301,154 | $ 20,843,902 |
Stock Options | 1,203,272 | 305,982 | 329,726 |
Research and development credit carryforward | 2,687,591 | 2,194,211 | 1,720,558 |
Accruals and others | 232,665 | 135,330 | 56,461 |
Lease liability | 3,997,114 | 289,287 | 300,991 |
Gross deferred tax assets | 35,311,296 | 25,225,964 | 23,251,638 |
Less valuation allowance | (31,242,130) | (24,794,474) | (22,857,741) |
Deferred Tax Assets, Net of Valuation Allowance | 4,069,166 | 431,490 | 393,897 |
Deferred tax liability: | |||
Fixed Assets | (4,069,166) | (431,490) | (393,897) |
Net deferred tax assets | $ 0 | $ 0 | $ 0 |
INCOME TAXES_ - Reconciliation
INCOME TAXES: - Reconciliation of income tax (expense) benefit (Details) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
INCOME TAXES: | |||
Federal statutory rate | 21.00% | 21.00% | 21.00% |
State taxes, net of federal benefit | (2.00%) | (9.50%) | (4.40%) |
Foreign rate differential | 2.30% | 3.30% | 3.70% |
Permanent items | (6.50%) | (2.00%) | (2.00%) |
Rate change and true-up | 11.80% | 17.00% | 8.00% |
Change in valuation allowance | (25.50%) | (21.60%) | (22.70%) |
R&D credit | 1.70% | 4.40% | 1.80% |
Effective income tax rate | 2.80% | 12.60% | 5.40% |
INCOME TAXES_ - Additional info
INCOME TAXES: - Additional information (Details) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating Loss Carryforwards [Line Items] | |||||
Proceeds from the sale of prior unused net operating loss carryovers | $ 736,000 | ||||
Net operating loss carry forwards | 83,500,000 | ||||
Valuation Allowance, Deferred Tax Asset, Increase, Amount | $ 6,447,656 | $ 1,936,732 | $ 4,623,931 | ||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 21.00% | 21.00% | ||
Operating Loss Carryforwards, Limitations on Use | 80% limitation on taxable income | ||||
Federal [Member] | |||||
Operating Loss Carryforwards [Line Items] | |||||
Net operating loss carry forwards | $ 83,500,000 | $ 35,700,000 | |||
Tax Credit Carryforward, Amount | 2,700,000 | ||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 35.00% | |||
State [Member] | |||||
Operating Loss Carryforwards [Line Items] | |||||
Net operating loss carry forwards | 9,300,000 | ||||
Tax Credit Carryforward, Amount | 70,000 | ||||
Foreign Tax Authority | |||||
Operating Loss Carryforwards [Line Items] | |||||
Net operating loss carry forwards | $ 29,900,000 |
COMMITMENTS AND CONTINGENCIES_
COMMITMENTS AND CONTINGENCIES: (Details) - USD ($) | Aug. 11, 2003 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Commitments and Contingencies Disclosure [Line Items] | |||||
Initial term (in years) | 3 years | ||||
Term of License Agreement | 18 years | ||||
Automatic renewal period for employment agreements | 1 year | ||||
Additional automatic renewed period for employment agreements | 1 year | ||||
Accrued tax liability | $ 598,000 | ||||
Accrued Expenses and Other Current Liabilities | 10,314,341 | $ 7,870,687 | |||
Employee related liabilities | $ 154,000 | 131,000 | $ 175,000 | $ 138,000 | |
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 | $ 641,000 | ||||
Royalty Agreements [Member] | |||||
Commitments and Contingencies Disclosure [Line Items] | |||||
Future royalty payment percentage on gross revenue | 3.00% | ||||
Royalty cost | $ 1,193,000 | 1,172,000 | 675,000 | ||
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 | $ 1,988,000 | $ 1,954,000 | $ 1,125,000 |
STOCKHOLDERS' EQUITY - Stock op
STOCKHOLDERS' EQUITY - Stock option activity (Details) - $ / shares | Feb. 28, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Shares | |||||
Outstanding | 5,165,204 | 4,218,189 | 3,658,462 | ||
Granted | 1,114,325 | 2,051,980 | 1,579,106 | 1,557,300 | |
Forfeited | (138,037) | (34,644) | (747,671) | ||
Expired | (21,756) | (226,440) | (16,320) | ||
Exercised | (171,413) | (371,007) | (233,582) | ||
Outstanding | 6,885,978 | 5,165,204 | 4,218,189 | 3,658,462 | |
Weighted Average Exercise Price per Share | |||||
Outstanding | $ 6.36 | $ 6.16 | $ 5.82 | ||
Granted | 8.78 | 6.37 | 7.19 | ||
Forfeited | 6.73 | 7.50 | 7.39 | ||
Expired | 7.46 | 5.60 | 4.16 | ||
Exercised | 5.73 | 4.46 | 4.09 | ||
Outstanding | $ 7.09 | $ 6.36 | $ 6.16 | $ 5.82 | |
Weighted Average Remaining Contractual Life (Years) | |||||
Outstanding | 7 years | ||||
Granted | 9 years 3 months 18 days | 9 years | 9 years 6 months | ||
Forfeited | 0 years | 0 years | 0 years | ||
Expired | 0 years | 0 years | 0 years | ||
Exercised | 0 years | 0 years | 0 years | ||
Outstanding | 7 years 1 month 24 days | 7 years 3 months 3 days | 7 years |
STOCKHOLDERS' EQUITY - Intrinsi
STOCKHOLDERS' EQUITY - Intrinsic value (Details) | 12 Months Ended |
Dec. 31, 2021USD ($)$ / sharesshares | |
Options Outstanding | |
Aggregate Intrinsic Value | $ | $ 3,883,000 |
Options Exercisable | |
Number Exercisable at September 30, 2021 | shares | 3,891,132 |
Weighted Average Exercise Price | $ 6.45 |
Aggregate Intrinsic Value | $ | $ 166,383 |
$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 September 30, 2021 | shares | 6,885,978 |
Weighted Average Exercise Price | $ 7.09 |
Weighted Average Remaining Life (Years) | 7 years 1 month 24 days |
Aggregate Intrinsic Value | $ | $ 166,383 |
STOCKHOLDERS' EQUITY - Non-vest
STOCKHOLDERS' EQUITY - Non-vested options (Details) - $ / shares | Feb. 28, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Shares | ||||
Non-vested, December 31, 2020 | 1,998,117 | |||
Granted | 1,114,325 | 2,051,980 | 1,579,106 | 1,557,300 |
Forfeited | (138,037) | |||
Vested | (917,214) | |||
Non-vested, September 30, 2021 | 2,994,846 | 1,998,117 | ||
Weighted Average Grant Date Fair Value | ||||
Non-vested, December 31, 2020 | $ 4.12 | |||
Granted | 5.26 | |||
Forfeited | 4.05 | |||
Vested | 4.34 | |||
Non-vested, September 30, 2021 | $ 4.68 | $ 4.12 |
STOCKHOLDERS' EQUITY - Restrict
STOCKHOLDERS' EQUITY - Restricted stock unit (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Restricted Stock Units, Intrinsic Value Beginning Balance | $ 19,504,184 | $ 8,033,988 | |
Restricted Stock Units, Intrinsic Value Ending Balance | $ 11,359,928 | $ 19,504,184 | $ 8,033,988 |
Restricted stock | |||
Restricted Stock Units, Beginning Balance | 2,447,200 | 2,086,750 | 2,004,000 |
Restricted Stock Units, Granted | 396,000 | 385,700 | 264,500 |
Restricted Stock Units, Forfeited | (132,000) | (25,250) | (181,750) |
Restricted Stock Units, Ending Balance | 2,711,200 | 2,447,200 | 2,086,750 |
Restricted stock | Board of Directors | |||
Restricted Stock Units, Beginning Balance | 277,200 | 277,200 | 277,200 |
Restricted Stock Units, Granted | 0 | 0 | 0 |
Restricted Stock Units, Forfeited | 0 | 0 | 0 |
Restricted Stock Units, Ending Balance | 277,200 | 277,200 | 277,200 |
Restricted stock | Executive Management | |||
Restricted Stock Units, Beginning Balance | 724,500 | 604,500 | 724,500 |
Restricted Stock Units, Granted | 0 | 120,000 | 0 |
Restricted Stock Units, Forfeited | 0 | 0 | (120,000) |
Restricted Stock Units, Ending Balance | 724,500 | 724,500 | 604,500 |
Restricted stock | Other Employees | |||
Restricted Stock Units, Beginning Balance | 1,445,500 | 1,205,050 | 1,002,300 |
Restricted Stock Units, Granted | 396,000 | 265,700 | 264,500 |
Restricted Stock Units, Forfeited | (132,000) | (25,250) | (61,750) |
Restricted Stock Units, Ending Balance | 1,709,500 | 1,445,500 | 1,205,050 |
STOCKHOLDERS' EQUITY - Restri_2
STOCKHOLDERS' EQUITY - Restricted stock unit activity (Details) - Restricted stock | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Shares | |
Non-vested, December 31, 2020 | shares | 173,972 |
Granted | shares | 327,515 |
Vested | shares | (196,525) |
Non-vested, September 30, 2021 | shares | 304,962 |
Weighted Average Grant Date Fair Value | |
Non-vested, December 31, 2020 | $ / shares | $ 6.52 |
Granted | $ / shares | 8.65 |
Vested | $ / shares | 7.64 |
Non-vested, September 30, 2021 | $ / shares | $ 8.08 |
STOCKHOLDERS' EQUITY - Fair val
STOCKHOLDERS' EQUITY - Fair value of stock option (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Stockholders Equity [Line Items] | |||
Exercise price per share | $ 4.19 | ||
Risk free rate maximum | 1.39% | ||
Exercise Price Ranging From 3.84 To 8.25 | |||
Stockholders Equity [Line Items] | |||
Expected life of the stock option | 10 years | ||
Expected dividends | 0.00% | ||
Risk free interest rate, minimum | 1.40% | ||
Risk free rate maximum | 2.61% | ||
Exercise Price Ranging From 3.84 To 8.25 | Maximum | |||
Stockholders Equity [Line Items] | |||
Exercise price per share | $ 8.25 | ||
Expected volatility | 74.30% | ||
Exercise Price Ranging From 3.84 To 8.25 | Minimum | |||
Stockholders Equity [Line Items] | |||
Exercise price per share | $ 3.84 | ||
Expected volatility | 61.90% | ||
Exercise Price Ranging from 5.00 to 10.58 | |||
Stockholders Equity [Line Items] | |||
Expected life of the stock option | 10 years | ||
Expected dividends | 0.00% | ||
Risk free interest rate, minimum | 0.28% | ||
Risk free rate maximum | 0.96% | ||
Exercise Price Ranging from 5.00 to 10.58 | Maximum | |||
Stockholders Equity [Line Items] | |||
Exercise price per share | $ 10.58 | ||
Expected volatility | 69.80% | ||
Exercise Price Ranging from 5.00 to 10.58 | Minimum | |||
Stockholders Equity [Line Items] | |||
Exercise price per share | $ 5 | ||
Expected volatility | 61.70% | ||
Exercise Price Ranging From 4.46 To 11.39 | |||
Stockholders Equity [Line Items] | |||
Expected life of the stock option | 10 years | ||
Expected dividends | 0.00% | ||
Risk free interest rate, minimum | 0.47% | ||
Exercise Price Ranging From 4.46 To 11.39 | Maximum | |||
Stockholders Equity [Line Items] | |||
Exercise price per share | $ 11.39 | ||
Expected volatility | 60.70% | ||
Exercise Price Ranging From 4.46 To 11.39 | Minimum | |||
Stockholders Equity [Line Items] | |||
Exercise price per share | $ 4.26 | ||
Expected volatility | 58.20% |
STOCKHOLDERS' EQUITY - Addition
STOCKHOLDERS' EQUITY - Additional information (Details) | Apr. 12, 2021USD ($)shares | Jul. 24, 2020USD ($)$ / sharesshares | Apr. 20, 2020USD ($) | Feb. 28, 2020USD ($)shares | Feb. 18, 2020 | Jul. 22, 2019USD ($)shares | Jul. 09, 2019USD ($) | Mar. 04, 2019USD ($)shares | Dec. 31, 2021USD ($)item$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Jul. 14, 2021USD ($) | Jun. 30, 2019shares | May 31, 2019shares | Dec. 31, 2018shares | Jul. 26, 2018USD ($) |
Stockholders Equity [Line Items] | ||||||||||||||||
Number of preferred stock authorized | shares | 5,000,000 | 5,000,000 | 5,000,000 | |||||||||||||
Number of common stock authorized | shares | 100,000,000 | 100,000,000 | 100,000,000 | 50,000,000 | ||||||||||||
Number of shares issued | shares | 4,301,869 | |||||||||||||||
Aggregate registered amount for offerings | $ 150,000,000 | $ 150,000,000 | ||||||||||||||
Average selling price | $ / shares | $ 6.53 | |||||||||||||||
Net proceeds from issuance of stock | $ 27,200,000 | |||||||||||||||
Expenses incurred | $ 90,000 | $ 49,000 | ||||||||||||||
Number of option granted | shares | 1,114,325 | 2,051,980 | 1,579,106 | 1,557,300 | ||||||||||||
Grant date fair value of these unvested options | $ 3,883,000 | |||||||||||||||
Stock or Unit Option Plan Expense | $ 1,070,000 | $ 914,000 | ||||||||||||||
Percentage of Milestone Activity Met by the Company | 88.00% | |||||||||||||||
Number of Long Term Incentive Plans | item | 2 | |||||||||||||||
Allocated share-based compensation expense | $ 4,021,000 | 3,514,000 | $ 1,666,000 | |||||||||||||
Exercise price per share | $ / shares | $ 4.19 | |||||||||||||||
Risk free rate maximum | 1.39% | |||||||||||||||
Total unrecognized compensation cost related to stock options | $ 5,932,000 | |||||||||||||||
Amortized period | 41 months | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Number of Shares | shares | 917,214 | |||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | $ 928,417 | $ 657,780 | $ 663,368 | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | shares | 6,885,978 | 5,165,204 | 4,218,189 | 3,658,462 | ||||||||||||
Class of Warrant or Right, Outstanding | shares | 0 | |||||||||||||||
Employees | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Number of option granted | shares | 1,323,400 | |||||||||||||||
Grant date fair value of unvested options | $ 7,042,000 | |||||||||||||||
Allocated share-based compensation expense | $ 273,000 | |||||||||||||||
Underwritten public offering | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Number of shares issued | shares | 6,052,631 | |||||||||||||||
Average selling price | $ / shares | $ 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 | shares | 91,750 | |||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ 713,868 | |||||||||||||||
Vesting period | 4 years | |||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | $ 178,000 | |||||||||||||||
Restricted stock | First 43,000 restricted stock | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | shares | 46,750 | |||||||||||||||
Restricted stock | Second 43,000 restricted stock | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | shares | 45,000 | |||||||||||||||
Restricted stock | Second anniversary of the date of the grant | First 43,000 restricted stock | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Vesting percentage | 1.00% | |||||||||||||||
Restricted stock | Third anniversary of the date of the grant | First 43,000 restricted stock | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Vesting percentage | 1.00% | |||||||||||||||
Restricted stock | Fourth anniversary of the date of the grant | First 43,000 restricted stock | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Vesting percentage | 1.00% | |||||||||||||||
Option | Employees | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Number of option granted | shares | 926,800 | |||||||||||||||
Grant date fair value of these unvested options | $ 4,294,000 | |||||||||||||||
Stock or Unit Option Plan Expense | $ 667,000 | $ 735,000 | ||||||||||||||
Percentage of Milestone Activity Met by the Company | 35.00% | |||||||||||||||
Stock Option Plan One [Member] | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Common stock reserved for issuance | shares | 2,400,000 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | shares | 237,000 | |||||||||||||||
Two Thousand Fourteen Stock Option Plan [Member] | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Common stock reserved for issuance | shares | 13,400,000 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | shares | 6,322,000 | |||||||||||||||
March 4, 2019 Performance-Based Award | Restricted stock | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | shares | 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 | 33,000 | ||||||||||||||
March 4, 2019 Performance-Based Award | Restricted stock | On the date of the grant | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||
March 4, 2019 Performance-Based Award | Restricted stock | First anniversary of the date of the grant | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||
March 4, 2019 Performance-Based Award | Restricted stock | Second anniversary of the date of the grant | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||
July 24,2020 Offering | Underwritten public offering | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Number of shares issued | shares | 6,052,631 | |||||||||||||||
Average selling price | $ / shares | $ 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 | Restricted stock | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | shares | 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 | 259,000 | 564,000 | ||||||||||||||
July 22, 2019 Performance-Based Award | Restricted stock | On the date of the grant | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||
July 22, 2019 Performance-Based Award | Restricted stock | First anniversary of the date of the grant | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||
July 22, 2019 Performance-Based Award | Restricted stock | Second anniversary of the date of the grant | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||
February 28 2020 Performance Based Award | Restricted stock | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | shares | 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 | 528,000 | $ 619,000 | ||||||||||||||
February 28 2020 Performance Based Award | Restricted stock | On the date of the grant | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||
February 28 2020 Performance Based Award | Restricted stock | First anniversary of the date of the grant | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||
February 28 2020 Performance Based Award | Restricted stock | Second anniversary of the date of the grant | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||
April 12, 2021 Performance Based Award | Restricted stock | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | shares | 235,765 | |||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ 2,120,000 | |||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | $ 1,207,000 | |||||||||||||||
April 12, 2021 Performance Based Award | Restricted stock | On the date of the grant | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||
April 12, 2021 Performance Based Award | Restricted stock | First anniversary of the date of the grant | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||
Jefferies LLC and B. Riley FBR, Inc | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Number of shares issued | shares | 4,110,625 | 191,244 | ||||||||||||||
aggregate offering price | $ 50,000,000 | $ 25,000,000 | ||||||||||||||
Average selling price | $ / shares | $ 6.64 | $ 4.11 | ||||||||||||||
Net proceeds from issuance of stock | $ 26,500,000 | $ 762,000 | ||||||||||||||
Commission rate (as a percent) | 3.00% | |||||||||||||||
Jefferies Llc | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
aggregate offering price | $ 25,000,000 | |||||||||||||||
Commission rate (as a percent) | 3.00% | |||||||||||||||
Exercise Price Ranging From 3.84 To 8.25 | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Expected life of the stock option | 10 years | |||||||||||||||
Expected dividends | 0.00% | |||||||||||||||
Risk free interest rate, minimum | 1.40% | |||||||||||||||
Risk free rate maximum | 2.61% | |||||||||||||||
Exercise Price Ranging From 3.84 To 8.25 | Maximum | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Exercise price per share | $ / shares | $ 8.25 | |||||||||||||||
Expected volatility | 74.30% | |||||||||||||||
Exercise Price Ranging From 3.84 To 8.25 | Minimum | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Exercise price per share | $ / shares | $ 3.84 | |||||||||||||||
Expected volatility | 61.90% | |||||||||||||||
Exercise Price Ranging from 5.00 to 10.58 | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Expected life of the stock option | 10 years | |||||||||||||||
Expected dividends | 0.00% | |||||||||||||||
Risk free interest rate, minimum | 0.28% | |||||||||||||||
Risk free rate maximum | 0.96% | |||||||||||||||
Exercise Price Ranging from 5.00 to 10.58 | Maximum | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Exercise price per share | $ / shares | $ 10.58 | |||||||||||||||
Expected volatility | 69.80% | |||||||||||||||
Exercise Price Ranging from 5.00 to 10.58 | Minimum | ||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||
Exercise price per share | $ / shares | $ 5 | |||||||||||||||
Expected volatility | 61.70% |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
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 | 9,902,000 | 7,786,000 | 6,503,000 |
RETIREMENT PLAN (Details)
RETIREMENT PLAN (Details) - USD ($) | Jan. 01, 2021 | Jun. 30, 2014 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Defined Contribution Plan Disclosure [Line Items] | |||||
Defined Contribution Plan, Maximum Annual Contributions Per Employee, Percent | 100.00% | ||||
Defined Contribution Plan, Employer Matching Contribution, Percent of Match | 20.00% | ||||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 5.00% | ||||
Term of employment required | 3 months | ||||
Defined Contribution Plan, Cost | $ 355,000 | $ 59,200 | $ 43,800 | ||
Participants contribution up to 3% | |||||
Defined Contribution Plan Disclosure [Line Items] | |||||
Defined Contribution Plan, Employer Matching Contribution, Percent of Match | 100.00% | ||||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 3.00% | ||||
Participants contribution over 3% and maximum 5% | |||||
Defined Contribution Plan Disclosure [Line Items] | |||||
Defined Contribution Plan, Employer Matching Contribution, Percent of Match | 50.00% | ||||
Minimum | Participants contribution over 3% and maximum 5% | |||||
Defined Contribution Plan Disclosure [Line Items] | |||||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 3.00% | ||||
Maximum | Participants contribution over 3% and maximum 5% | |||||
Defined Contribution Plan Disclosure [Line Items] | |||||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 5.00% |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) $ in Millions | Jan. 19, 2022USD ($) |
Subsequent event | Bridge Loan | Fourth Amendment | |
Subsequent Event [Line Items] | |
Other Commitment | $ 15 |
QUARTERLY FINANCIAL RESULTS (_3
QUARTERLY FINANCIAL RESULTS (UNAUDITED) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||||||
Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
QUARTERLY FINANCIAL RESULTS (UNAUDITED) | |||||||||||||||
Total revenue | $ 10,782,195 | $ 9,760,416 | $ 12,024,069 | $ 10,598,847 | $ 11,955,776 | $ 10,546,612 | $ 9,794,903 | $ 8,707,310 | $ 7,430,311 | $ 6,095,007 | $ 6,232,526 | $ 5,191,629 | $ 43,165,527 | $ 41,004,601 | $ 24,949,473 |
Gross margin | 7,659,452 | 7,297,470 | 9,313,852 | 7,847,403 | 9,428,358 | 7,656,230 | 6,545,136 | 6,322,468 | 5,335,621 | 4,398,733 | 4,398,160 | 3,453,040 | 32,118,177 | 29,952,192 | 17,585,554 |
Loss from operations | (9,561,821) | (5,406,000) | (4,924,733) | (2,852,191) | (2,634,264) | (1,959,652) | (3,297,667) | (2,478,754) | (5,431,328) | (5,627,546) | (3,629,997) | (4,285,193) | (22,744,745) | (10,370,334) | (18,974,064) |
Net loss attributable to common stockholders | $ (9,307,012) | $ (6,406,285) | $ (4,677,530) | $ (4,167,821) | $ (677,724) | $ (839,729) | $ (2,866,956) | $ (3,452,779) | $ (3,949,351) | $ (6,885,061) | $ (3,547,405) | $ (4,883,827) | $ (24,558,648) | $ (7,837,188) | $ (19,265,644) |
Basic net loss per common share | $ (0.25) | $ (0.15) | $ (0.11) | $ (0.10) | $ 0 | $ (0.02) | $ (0.08) | $ (0.10) | $ (0.13) | $ (0.21) | $ (0.11) | $ (0.15) | $ (0.57) | $ (0.20) | $ (0.60) |
Diluted net loss per common share | $ (0.18) | $ (0.15) | $ (0.11) | $ (0.10) | $ 0 | $ (0.02) | $ (0.08) | $ (0.10) | $ (0.13) | $ (0.21) | $ (0.11) | $ (0.15) | $ (0.57) | $ (0.20) | $ (0.60) |