Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 02, 2020 | Jun. 30, 2019 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Cytosorbents Corp | ||
Entity Central Index Key | 0001175151 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 178,694,000 | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | No | ||
Trading Symbol | CTSO | ||
Entity Common Stock, Shares Outstanding | 35,051,193 | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | true |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Current Assets: | ||
Cash and cash equivalents | $ 12,232,418 | $ 22,368,837 |
Grants and accounts receivable, net of allowance for doubtful accounts of $145,313 and $83,726 at December 31, 2019 and 2018, respectively | 4,467,087 | 3,943,119 |
Inventories | 2,113,897 | 833,133 |
Prepaid expenses and other current assets | 2,088,127 | 1,118,998 |
Total current assets | 20,901,529 | 28,264,087 |
Property and equipment, net | 1,925,325 | 1,729,860 |
Right of use asset | 1,070,762 | 1,449,437 |
Other assets | 3,484,894 | 2,753,379 |
Total Assets | 27,382,510 | 34,196,763 |
Current Liabilities: | ||
Accounts payable | 2,039,222 | 1,485,812 |
Accrued expenses and other current liabilities | 5,802,296 | 4,385,720 |
Current maturities of long-term debt | 1,666,666 | 666,667 |
Lease liability - current portion | 428,083 | 378,675 |
Total current liabilities | 9,936,267 | 6,916,874 |
Lease liability, net of current portion | 642,679 | 1,070,762 |
Long term debt, net of current maturities and debt issuance costs | 13,385,522 | 9,274,527 |
Total Liabilities | 23,964,468 | 17,262,163 |
Commitments and contingencies (Note 10) | ||
Stockholders' Equity: | ||
Common Stock, Par Value $0.001, 100,000,000 shares authorized; 32,616,107 and 31,774,139 shares issued and outstanding at December 31, 2019 and 2018, respectively | 32,616 | 31,774 |
Additional paid-in capital | 191,648,907 | 186,138,466 |
Accumulated other comprehensive income | 525,978 | 288,175 |
Accumulated deficit | (188,789,459) | (169,523,815) |
Total Stockholders' Equity | 3,418,042 | 16,934,600 |
Total Liabilities and Stockholders' Equity | $ 27,382,510 | $ 34,196,763 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
CONSOLIDATED BALANCE SHEETS | ||
Allowance for doubtful accounts | $ 145,313 | $ 83,726 |
Common Stock, Par Value | $ 0.001 | $ 0.001 |
Number of common stock authorized | 100,000,000 | 100,000,000 |
Common Stock, shares issued | 32,616,107 | 31,774,139 |
Common Stock, shares outstanding | 32,616,107 | 31,774,139 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue: | |||
Total revenue | $ 24,949,473 | $ 22,503,908 | $ 15,150,754 |
Cost of revenue | 7,363,919 | 7,489,400 | 5,518,360 |
Gross profit | 17,585,554 | 15,014,508 | 9,632,394 |
Operating expenses: | |||
Research and development | 12,091,797 | 7,723,028 | 3,221,233 |
Legal, financial and other consulting | 2,462,151 | 2,002,032 | 1,339,493 |
Selling, general and administrative | 22,005,670 | 20,874,376 | 14,914,266 |
Total operating expenses | 36,559,618 | 30,599,436 | 19,474,992 |
Loss from operations | (18,974,064) | (15,584,928) | (9,842,598) |
Other income (expense): | |||
Interest expense, net | (1,033,661) | (1,461,045) | (749,076) |
Gain/(loss) on foreign currency transactions | (350,365) | (784,752) | 1,454,136 |
Total other income (expense), net | (1,384,026) | (2,245,797) | 705,060 |
Loss before benefit from income taxes | (20,358,090) | (17,830,725) | (9,137,538) |
Benefit from income taxes | 1,092,446 | 619,546 | 676,739 |
Net loss | (19,265,644) | (17,211,179) | (8,460,799) |
Dividend, warrant exercise price adjustment | (335,731) | ||
Net loss attributable to common shareholders | $ (19,265,644) | $ (17,211,179) | $ (8,796,530) |
Basic and diluted net loss per common share | $ (0.60) | $ (0.56) | $ (0.32) |
Weighted average number of shares of common stock outstanding | 32,255,253 | 30,719,176 | 27,613,911 |
Comprehensive loss: | |||
Net loss | $ (19,265,644) | $ (17,211,179) | $ (8,460,799) |
Other comprehensive income (loss): | |||
Currency translation adjustment | 237,803 | 649,160 | (1,259,669) |
Comprehensive loss | (19,027,841) | (16,562,019) | (9,720,468) |
Product | |||
Revenue: | |||
Total revenue | 22,765,854 | 20,252,383 | 13,381,853 |
Cyto Sorb Sales [Member] | |||
Revenue: | |||
Total revenue | 22,545,754 | 20,143,354 | 13,254,953 |
Other Sales [Member] | |||
Revenue: | |||
Total revenue | 220,100 | 109,029 | 126,900 |
Grant | |||
Revenue: | |||
Total revenue | $ 2,183,619 | $ 2,251,525 | $ 1,768,901 |
CONSOLIDATED STATEMENT OF CHANG
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive (Loss) [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2016 | $ 25,484 | $ 143,929,397 | $ 898,684 | $ (143,516,106) | $ 1,337,459 |
Balance (in shares) at Dec. 31, 2016 | 25,483,966 | ||||
Stock based compensation - employees, consultants and directors | $ 0 | 3,313,603 | 0 | 0 | 3,313,603 |
Issuance of common stock - offerings, net of fees incurred | $ 3,106 | 13,676,624 | 0 | 0 | 13,679,730 |
Issuance of common stock - offerings, net of fees incurred (in shares) | 3,105,555 | ||||
Issuance of restricted stock options | $ 41 | 207,567 | 0 | 0 | 207,608 |
Issuance of restricted stock options (in shares) | 41,390 | ||||
Proceeds from exercise of warrants | $ 192 | 852,812 | 0 | 0 | 853,004 |
Proceeds from exercise of warrants (in shares) | 192,001 | ||||
Cashless exercise of warrants | $ 2 | (2) | 0 | 0 | 0 |
Cashless exercise of warrants (in shares) | 1,516 | ||||
Proceeds from exercise of stock options | $ 146 | 591,753 | 0 | 0 | 591,899 |
Proceeds from exercise of stock options (in shares) | 145,848 | ||||
Cashless exercise of stock options | $ 3 | (3) | 0 | 0 | 0 |
Cashless exercise of stock options (in shares) | 3,403 | ||||
Dividend, warrant exercise price adjustment | $ 0 | 335,731 | 0 | (335,731) | 0 |
Other comprehensive income, foreign translation adjustment | 0 | 0 | (1,259,669) | 0 | (1,259,669) |
Net loss | 0 | 0 | 0 | (8,460,799) | (8,460,799) |
Balance at Dec. 31, 2017 | $ 28,974 | 162,907,482 | (360,985) | (152,312,636) | 10,262,835 |
Balance (in shares) at Dec. 31, 2017 | 28,973,679 | ||||
Stock based compensation - employees, consultants and directors | $ 0 | 4,437,250 | 0 | 0 | 4,437,250 |
Issuance of common stock - offerings, net of fees incurred | $ 1,515 | 14,125,010 | 0 | 0 | 14,126,525 |
Issuance of common stock - offerings, net of fees incurred (in shares) | 1,515,260 | ||||
Issuance of restricted stock options | $ 62 | 545,631 | 0 | 0 | 545,693 |
Issuance of restricted stock options (in shares) | 62,406 | ||||
Proceeds from exercise of warrants | $ 314 | 1,280,142 | 0 | 0 | 1,280,456 |
Proceeds from exercise of warrants (in shares) | 313,802 | ||||
Cashless exercise of warrants | $ 89 | (89) | 0 | 0 | 0 |
Cashless exercise of warrants (in shares) | 89,556 | ||||
Proceeds from exercise of stock options | $ 684 | 2,206,176 | 0 | 0 | 2,206,860 |
Proceeds from exercise of stock options (in shares) | 683,673 | ||||
Cashless exercise of stock options | $ 67 | (67) | 0 | 0 | 0 |
Cashless exercise of stock options (in shares) | 66,972 | ||||
Success fee-Bridge Bank | $ (69) | (636,931) | 0 | 0 | (637,000) |
Success fee-Bridge Bank (in shares) | 68,791 | ||||
Other comprehensive income, foreign translation adjustment | $ 0 | 0 | 649,160 | 0 | 649,160 |
Net loss | 0 | 0 | 0 | (17,211,179) | (17,211,179) |
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 | 2,626,330 | |||
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 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | |||
Net loss | $ (19,265,644) | $ (17,211,179) | $ (8,460,799) |
Adjustments to reconcile net loss to net cash used by operating activities: | |||
Non-cash interest expense | 0 | 637,000 | 0 |
Non-cash compensation | 1,173,743 | 947,910 | 691,480 |
Depreciation and amortization | 581,532 | 390,551 | 218,271 |
Bad debt expense | 72,429 | 14,762 | 904 |
Foreign currency transaction (gains) losses | 350,365 | 784,752 | (1,454,136) |
Stock-based compensation | 1,666,024 | 4,437,250 | 3,313,603 |
Amortization of loan acquisition costs | 115,206 | 97,041 | 82,054 |
Changes in operating assets and liabilities: | |||
Grants and accounts receivable | (642,171) | (1,847,848) | (649,318) |
Inventories | (1,284,848) | (56,751) | 57,320 |
Prepaid expenses and other current assets | (953,888) | (731,672) | (76,981) |
Other assets | 4,030 | (6,345) | (15,000) |
Accounts payable and accrued expenses | 1,424,440 | 1,704,845 | (168,103) |
Net cash used by operating activities | (16,758,782) | (10,839,684) | (6,460,705) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (698,165) | (671,970) | (990,673) |
Patent costs | (821,952) | (848,294) | (687,446) |
Net cash used by investing activities | (1,520,117) | (1,520,264) | (1,678,119) |
Cash flows from financing activities: | |||
Proceeds from long-term debt | 5,000,000 | 666,667 | 5,000,000 |
Repayment of long-term debt | 0 | (666,667) | 0 |
Payment of loan acquisition costs | (4,212) | (147,988) | (1,560) |
Equity contributions - net of fees incurred | 673,653 | 14,126,525 | 13,679,730 |
Proceeds from exercise of stock options | 739,747 | 2,206,860 | 591,899 |
Proceeds from exercise of warrants | 1,768,491 | 1,280,456 | 853,004 |
Net cash provided by financing activities | 8,177,679 | 17,465,853 | 20,123,073 |
Effect of exchange rates on cash | (35,199) | (58,930) | 92,435 |
Net change in cash and cash equivalents | (10,136,419) | 5,046,975 | 12,076,684 |
Cash and cash equivalents - beginning of period | 22,368,837 | 17,321,862 | 5,245,178 |
Cash and cash equivalents - end of period | 12,232,418 | 22,368,837 | 17,321,862 |
Supplemental disclosure of cash flow information: | |||
Cash paid during the period for interest | 1,059,541 | 891,386 | 634,608 |
Supplemental disclosure of non-cash financing activities | |||
Settlement of accrued bonuses with restricted stock units | 425,639 | 545,693 | 207,608 |
Dividend, warrant exercise price adjustment | $ 0 | $ 0 | $ 335,731 |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 12 Months Ended |
Dec. 31, 2019 | |
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”. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Based on its projections, the Company believes it will have to raise additional capital to fund its planned operations over the next twelve-month period. As of December 31, 2019, the Company had an accumulated deficit of $188,789,459, which included net losses of $19,265,644 for the year ended December 31, 2019, $17,211,179 for the year ended December 31, 2018 and $8,460,799 for the year ended December 31, 2017. The Company’s losses have resulted principally from costs incurred in the research and development of the Company’s polymer technology and selling, general and administrative expenses. The Company intends to continue to conduct significant additional research, development, and clinical study activities which, together with expenses incurred for the establishment of manufacturing arrangements and a marketing and distribution presence and other selling, general and administrative expenses, are expected to result in continuing operating losses for the foreseeable future. The amount of future losses and when, if ever, the Company will achieve profitability are uncertain. The Company’s ability to achieve profitability will depend, among other things, on successfully completing the development of its technology and commercial products, obtaining additional requisite regulatory approvals in markets not covered by the CE Mark previously received for the Company’s CytoSorb product and for potential label extensions of the Company’s current CE Mark, establishing manufacturing and sales and marketing arrangements with third parties, and raising sufficient funds to finance the Company’s activities. No assurance can be given that the Company’s product development efforts will be successful, that the Company’s current CE Mark will enable it to achieve profitability, that additional regulatory approvals in other countries will be obtained, that any of the Company’s products will be manufactured at a competitive cost and will be of acceptable quality, or that the Company will be able to achieve profitability or that profitability, if achieved, can be sustained. These matters raise substantial doubt about the Company’s ability to continue as a going concern. These consolidated financial statements do not include any adjustments related to the outcome of this uncertainty. |
PRINCIPAL BUSINESS ACTIVITY AND
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: | 12 Months Ended |
Dec. 31, 2019 | |
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 critical care immunotherapy leader commercializing its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world. The Company, through its subsidiary CytoSorbents Medical, Inc. (formerly known as CytoSorbents, Inc.), is engaged in the research, development and commercialization of medical devices with its blood purification technology platform which incorporates a proprietary adsorbent, porous polymer technology. The Company, through its wholly owned European subsidiary, CytoSorbents Europe GmbH, conducts sales and marketing related operations for the Company's flagship product, CytoSorb. In March 2016, the Company formed CytoSorbents Switzerland GmbH, a wholly-owned subsidiary of CytoSorbents Europe GmbH. This subsidiary, which began operations during the second quarter of 2016, provides marketing and direct sales services in Switzerland. In November 2018, the Company formed CytoSorbents Poland Sp. z.o.o., a wholly-owned subsidiary of CytoSorbents Europe GmbH. This subsidiary, which began operations during the first quarter of 2019, provides marketing and direct sales services in Poland. In the third quarter of 2019, the Company formed CytoSorbents UK Limited, a wholly-owned subsidiary of CytoSorbents Medical, Inc. which is responsible for the management of our clinical trial activities in the United Kingdom. CytoSorb was approved in the European Union (“EU”) in March 2011, and is currently being distributed in fifty-eight countries around the world, as a safe and effective extracorporeal cytokine absorber, designed to reduce the “cytokine storm” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. In May 2018, the Company received a label extension for CytoSorb covering use of the device for the removal of bilirubin and myoglobin which allows for the use of the device in the treatment of liver failure and trauma, respectively. In January 2020, the Company received a label extension for CytoSorb covering the use of the device for the removal the anti-platelet agent, ticagrelor, in cardiac patients during surgery requiring cardiopulmonary bypass. CytoSorb is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. The Company's 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 absorption. 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, and others. These patents and patent applications are directed to various compositions and methods of use related to our blood purification technologies. The existing patents are scheduled to expire between 2020 and 2035, absent any patent term extensions. Management believes that any near term expiring patents will not have a significant impact on our ongoing business. Stock Market Listing On December 17, 2014 the Company’s common stock 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 $(350,000), $(785,000) and $1,454,000 for the years ended December 31, 2019, 2018 and 2017, 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 stockholder’s 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. 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 written off to 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, 2019 and 2018, the Company’s inventory was comprised of finished goods, which amounted to $305,452 and $213,839, respectively, work in process which amounted to $1,523,923 and $415,265, respectively and raw materials which amounted to $284,522 and $204,029, 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: Revenues from sales of products to both direct and distributor/strategic partner customers are recognized at the time when control passes to the customer, in accordance with the terms of their respective contracts. Recognition of revenue occurs as each performance obligation is completed. Grant Revenue : Revenue from grant income is based on contractual agreements. Certain agreements provide for reimbursement of costs, other agreements provide for reimbursement of costs and an overhead margin and certain agreements are performance based, where revenue is earned based upon the achievement of milestones outlined in the contract. Revenues are recognized when the associated performance obligation is fulfilled. Costs are recorded as incurred. Costs subject to reimbursement by these grants have been reflected as costs of revenue. Research and Development All research and development costs, payments to laboratories, 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 $314,000, $212,000 and $162,000 in 2019, 2018 and 2017, respectively, and is included in selling, general, and administrative expenses on the consolidated statements of operations. 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 (the “Act”) was enacted on December 22, 2017. The Act reduces 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, 2019 or 2018. 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 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. Significant estimates in these financials are the valuation of options granted and valuation methods used to determine the change in fair value of the down round feature related to certain of the Company’s outstanding warrants. Concentration of Credit Risk The Company maintains cash balances, at times, with financial institutions in excess of amounts insured by the Federal Deposit Insurance Corporation. Management monitors the soundness of these institutions in an effort to minimize its collection risk of these balances. A significant portion of our revenues are from product sales in Germany. Substantially all of our grant and other income are from grant agencies in the United States. (See Note 3 for further information relating to the Company’s revenue.) As of December 31, 2019, no agency, distributor/strategic partners or direct customer represented more than 10% of outstanding grants and accounts receivables. As of December 31, 2018, two distributors/strategic partners accounted for 29 percent of the outstanding grants and accounts receivables. For the years ended December 31, 2019, 2018 and 2017, 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 other debt obligations approximate their fair values due to their short-term nature. Net Loss per Common Share Basic earnings per share is computed by dividing loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per common share is computed using the treasury stock method on the basis of the weighted-average number of shares of common stock plus the dilutive effect of potential common shares outstanding during the period. Dilutive potential common shares include outstanding warrants, stock options and restricted shares. The computation of diluted earnings per share does not assume conversion, exercise or contingent exercise of securities that would have an anti-dilutive effect on earnings (See Note 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. Effects of Recent Accounting Pronouncements In February 2016, the FASB issued ASU 2016‑02, “Leases (Topic 842)”. ASU 2016‑02 outlines reporting requirements for lessees to recognize a right-of-use asset and corresponding liability on the balance sheet for all leases covering a period of greater than 12 months. The liability is to be measured as the present value of the future minimum lease payments, plus any initial direct costs. The minimum payments are discounted using the rate implicit in the lease, or, if not known, the lessee’s incremental borrowing rate. The updated guidance is effective for public entities for fiscal years beginning after December 31, 2018. The Company adopted the updated guidance effective January 1, 2019. See Note 8 for details regarding the Company's leases. S hipping 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 $476,000, $424,000 and $257,000 for the years ended December 31, 2019, 2018 and 2017, respectively. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2019 | |
Revenue | |
Revenue | 3. Revenue On January 1, 2018, the Company adopted the new accounting standard ASC 606, Revenue from Contracts with Customers and all related amendments (the “new revenue standard”) to all contracts with customers using the modified retrospective method. The adoption of the new revenue standard had no impact on retained earnings as of December 31, 2017 and, accordingly, no cumulative adjustment was required. We do not expect the new revenue standard to have a significant impact on our net income on an ongoing basis. 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 following table disaggregates the Company’s revenue by customer type and geographic area for the year ended December 31, 2018: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 95,500 $ — $ — $ 95,500 Germany 11,771,645 — — 11,771,645 All other countries 2,702,689 5,682,549 — 8,385,238 Total product revenue 14,569,834 5,682,549 — 20,252,383 Grant and other income: United States — — 2,251,525 2,251,525 Total revenue $ 14,569,834 $ 5,682,549 $ 2,251,525 $ 22,503,908 The following table disaggregates the Company’s revenue by customer type and geographic area for the year ended December 31, 2017: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 126,900 $ — $ — $ 126,900 Germany 7,906,851 — — 7,906,851 All other countries 1,771,144 3,576,958 — 5,348,102 Total product revenue 9,804,895 3,576,958 — 13,381,853 Grant and other income: United States — — 1,768,901 1,768,901 Total revenue $ 9,804,895 $ 3,576,958 $ 1,768,901 $ 15,150,754 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. All sales of the device are outside the United States, as CytoSorb is not yet approved in the United States. Direct sales are fulfilled from the Company’s office in Berlin, Germany. Direct sales relate to sales to hospitals located in Germany, Switzerland, Austria, Belgium, Luxembourg, Poland, the Netherlands, Sweden, Denmark and Norway. There are no formal sales contracts with any direct customers relating to product price or minimum purchase requirements. However, there are agreements in place with certain direct customers that provide for either free of charge product or rebate credits based upon achieving minimum purchase levels. The Company records the value of these items earned as a reduction of revenue. These customers submit purchase orders and the order is fulfilled and shipped directly to the customer. Prices to all direct customers are based on a standard price list based on the packaged quantity (6 packs vs 12 packs). Distributor and strategic partner sales make up the remaining product sales. These distributors are located in various countries throughout the world. The Company has a formal written contract with each distributor/strategic partner. These contracts have terms ranging from 1-5 years in length, with three years being the typical term. In addition, certain distributors are eligible for volume discount pricing if their unit sales are in excess of the base amount in the contract. Each distributor’s/strategic partner’s contract has 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 contacts fall into one of the following categories: 1. Fixed price – the Company invoices the contract amount in equal installments over the term of the contract without regard to the timing of the costs incurred related to this contract. 2. Cost reimbursement – the Company submits monthly invoices during the term of the contract for the amount of direct costs incurred during that month plus an agreed percentage that relates to allowable overhead and general and administrative expenses. Cumulative amounts invoiced may not exceed the maximum amount of funding stipulated in the contract. 3. Cost plus – this type of contract is similar to a cost reimbursement contract but this type also allows for the Company to additionally invoice for a fee amount that is included in the contract. 4. Performance based - the Company submits invoices only upon the achievement of the milestones listed in the contract. The amount to be invoiced for each milestone is documented in the contract. In summary, the contracts the Company has with customers are the distributor/strategic partner contracts related to CytoSorb product sales, agreements with direct customers related to free-of-charge product and credit rebates based upon achieving minimum purchase levels, and contracts with various government agencies related to the Company’s grants. The Company does not currently incur any outside/third party incremental costs to obtain any of these contracts. The Company does incur internal costs, primarily salary related costs, to obtain the contracts related to the grants. Company employees spend time reviewing the program requirements and developing the budget and related proposal to submit to the grantor agency. There may additionally be travel expenditures involved with meeting with government agency officials during the negotiation of the contract. These internal costs are expensed as incurred. The following table provides information about receivables and contract liabilities from contracts with customers: December 31, 2019 December 31, 2018 Receivables, which are included in grants and accounts receivable $ 2,246,821 $ 2,399,662 Contract liabilities, which are included in accrued expenses and other current liabilities $ 171,842 $ 42,219 Contract liabilities represent the value of free of charge goods and credit rebates earned in accordance with the terms of certain direct customer agreements during the years ended December 31, 2019 and December 31, 2018. |
PROPERTY AND EQUIPMENT, NET_
PROPERTY AND EQUIPMENT, NET: | 12 Months Ended |
Dec. 31, 2019 | |
PROPERTY AND EQUIPMENT, NET: | |
PROPERTY AND EQUIPMENT, NET: | 4. PROPERTY AND EQUIPMENT, NET: Property and equipment - net, consists of the following: Depreciation/ Amortization December 31, 2019 2018 Period Furniture and fixtures $ 795,167 $ 621,702 7 years Equipment and computers 3,861,912 3,340,282 3 to 7 years Leasehold improvements 927,894 942,228 Lesser of term of lease or estimated useful life 5,584,973 4,904,212 Less accumulated depreciation and amortization 3,659,648 3,174,352 Property and Equipment, Net $ 1,925,325 $ 1,729,860 Depreciation expense for the years ended December 31, 2019, 2018 and 2017 amounted to $495,728, $329,469 and $177,776 respectively. |
OTHER ASSETS_
OTHER ASSETS: | 12 Months Ended |
Dec. 31, 2019 | |
OTHER ASSETS: | |
OTHER ASSETS: | 5. OTHER ASSETS: Other assets consist of the following: December 31, 2019 2018 Patents $ 3,751,468 $ 2,929,517 Less accumulated amortization (390,056) (304,252) Patents, net 3,361,412 2,625,265 Security deposits 123,482 128,114 Total $ 3,484,894 $ 2,753,379 Amortization expense amounted to $85,804, $61,082 and $40,495 for the years ended December 31, 2019, 2018 and 2017, respectively. Amortization expense for the next five years will be approximately $94,300 for the year ended December 31, 2020; approximately $92,200 for the year ended December 31, 2021; approximately $88,900 for the year ended December 31, 2022; approximately $85,600 for the year ended December 31, 2023; and approximately $85,600 for the year ended December 31, 2024. |
ACCRUED EXPENSES AND OTHER CURR
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: | 12 Months Ended |
Dec. 31, 2019 | |
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, 2019 2018 Accrued salaries and commissions $ 1,926,167 $ 1,840,457 Clinical studies 1,384,564 822,085 Accrued accounts payable 629,186 479,783 Accrued royalties 525,004 433,589 Sales, payroll and income taxes payable 402,816 182,753 Professional fees 394,088 280,381 Travel and entertainment 214,436 187,047 Customer rebates 157,656 — Interest 108,629 76,726 Board of Director fees 59,750 31,350 Congresses — 51,549 $ 5,802,296 $ 4,385,720 |
LONG-TERM DEBT
LONG-TERM DEBT | 12 Months Ended |
Dec. 31, 2019 | |
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 “Closing Date”), the Original Term Loans were refinanced with the Bank pursuant to an Amended and Restated Loan and Security Agreement by and between the Bank and the Borrower (the “Amended and Restated Loan and Security Agreement”), under which the Bank agreed to loan the Borrower up to an aggregate of $15 million to be disbursed in two tranches (1) one tranche of $10 million (the “Term A Loan”), which was funded on the Closing Date and used to refinance the Original Term Loans, and (2) a second tranche of $5 million which 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 "Settlement Date"), the Borrower entered into the First Amendment to the Amended and Restated Loan and Security Agreement (the "First Amendment") with the Bank, which amended certain provisions of the Amended and Restated Loan and Security Agreement and the 2018 Success Fee Letter (the "2018 Letter"). In connection with the execution of the First Amendment, the draw period for the Term B Loan was extended to August 15, 2019 and the Company drew down the full $5.0 million Term B Loan on the Settlement Date, bringing the total outstanding debt to $15,000,000 at July 31, 2019. The proceeds of Term Loans were used for general business requirements in accordance with the Amended and Restated Loan and Security Agreement. The outstanding balances on Term Loans bear interest at the prime rate reported in the Wall Street Journal plus 3.66%. This rate was 8.41% at December 31, 2019. On the Closing Date, the Company was required to pay a non-refundable closing fee of $25,000, expenses incurred by the Bank related to the Amended and Restated Loan and Security Agreement of $11,000 and a portion of the final fee for the period the Original Term Loans were outstanding of $85,938. In addition, the Company incurred legal expenses related to the Amended and Restated Loan and Security Agreement of $20,050 and $4,212 related to the First Amendment. As of the Settlement Date, the total unamortized loan costs related to the Term Loans amounted to $90,925. These costs have been presented as a direct deduction from the proceeds of the loan on the consolidated balance sheet in accordance with the provisions of ASC 850. These costs are being amortized over the loan period as a charge to interest expense. For the years ended December 31, 2019, 2018 and 2017, the Company recorded interest expense amounting to $33,175, $31,946, and $29,971, respectively related to these costs. After accounting for the various costs outlined above, the effective interest rate on the Term A Loan was 9.1% as of March 29, 2018. Under the terms of the First Amendment, commencing on the first calendar day of the calendar month after Term B Loan was made, the Company is required to make monthly payments of interest-only through April 2020. The interest-only period will be further extended through November 2020 provided the Borrower has been compliant with its obligations under the financial covenant revenue test set forth in the Amended and Restated Loan and Security Agreement for all months from the month immediately after the month in which the Term B Loan is funded through March 2020. Commencing on May 1, 2020, if the Company does not comply with financial covenant revenue test, the Company shall make equal monthly payments of principal of $625,000, together with accrued and unpaid interest. Commencing on November 1, 2020, if the Company complies with the financial covenant revenue test, the Company shall make equal monthly payments of principal of $833,333, together with accrued and unpaid interest. In either event, all unpaid principal and accrued and unpaid interest shall be due and payable in full on April 1, 2022. In addition, the Amended and Restated Loan and Security Agreement requires the Company to pay a non-refundable final fee equal to 2.5% of the principal amount of each Term Loan funded upon the earlier of the (i) April 1, 2022 maturity date or (ii) termination of the Term Loan via acceleration or prepayment. This final fee is being accrued and charged to interest expense over the term of the loan. For the years ended December 31, 2019, 2018 and 2017, the Company recorded interest expense of $82,031, $65,104 and 52,083, respectively, related to the final fee. The Term Loans are evidenced by a secured promissory notes issued to the Bank by the Company. If the Company elects to prepay the Term Loans pursuant to the terms of the Amended and Restated Loan and Security Agreement, it will owe a prepayment fee to the Bank, as follows: (1) for a prepayment made on or after the funding date of a Term Loan through and including the first anniversary of such funding date, an amount equal to 2.0% of the principal amount of such Term Loan prepaid; (2) for a prepayment made after the first anniversary of the funding date of a Term Loan through and including the second anniversary of such funding date, an amount equal to 1.5% of the principal amount of such Term Loan prepaid; and (3) for a prepayment made after the second anniversary of the funding date of a Term Loan through April 1, 2022, an amount equal to 1.0% of the principal amount of such Term Loan prepaid. Events of default which may cause repayment of the Term Loans to be accelerated include, among other customary events of default, (1) non-payment of any obligation when due, (2) the failure to perform any obligation required under the Amended and Restated Loan and Security Agreement and to cure such default within a reasonable time frame, (3) the occurrence of a Material Adverse Event (as defined in the Amended and Restated Loan and Security Agreement), (4) the attachment or seizure of a material portion of the Borrower’s assets if such attachment or seizure is not released, discharged or rescinded within 10 days, and (5) if the Borrower becomes insolvent or starts an insolvency proceeding or if an insolvency proceeding is brought by a third party against the Borrower and such proceeding is not dismissed or stayed within 30 days. The Amended and Restated Loan and Security Agreement includes customary loan conditions, Borrower representations and warranties, Borrower affirmative covenants and Borrower negative covenants for secured transactions of this type. The Company is in substantial compliance with these covenants. The Company’s and CytoSorbents Medical, Inc.’s obligations under the Amended and Restated Loan and Security Agreement are joint and severable and are secured by a first priority security interest in favor of the Bank with respect to the Company’s Shares (as defined in the Amended and Restated Loan and Security Agreement) and the Borrower’s Collateral (as defined in the Amended and Restated Loan and Security Agreement, which definition excludes the Borrower’s intellectual property and other customary exceptions). 2016 Success Fee Letter: Pursuant to that certain Success Fee Letter (the “2016 Letter”) entered into between the Borrower and the Bank in connection with the Original Term Loans, the Borrower agreed to pay to the Bank a success fee in the amount equal to 6.37% of the funded amount of the Original Term Loans (the “2016 Letter 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 Nasdaq being $8.00 (after giving effect to any stock splits or consolidations effected after the date thereof) or more for five successive business days. On May 18, 2018, the 2016 Letter Success Fee became due to the Bank as result of an occurrence of the event described in clause (d) above. The Company elected to satisfy the 2016 Letter Success Fee by issuing shares of its common stock, which was permitted under the terms of the 2016 Letter. On May 23, 2018, the Company issued 68,791 shares of its common stock in full satisfaction of the 2016 Letter Success Fee, and the obligations of the Borrower under the 2016 Letter. The 2016 Letter Success Fee was valued at $637,000 and was charged to interest expense. 2018 Success Fee Letter: Pursuant to the amended 2018 Letter, the Borrower shall pay to the Bank a success fee in the amount equal to 6.37% of the funded amount of the Term B Loan (as defined in the Restated Loan and Security Agreement) (the "Success Fee”) upon the first occurrence of any of the following events: (a) a sale or other disposition by the Borrower of all or substantially all of its assets; (b) a merger or consolidation of the Borrower into or with another person or entity, where the holders of the Borrower’s outstanding voting equity securities as of immediately prior to such merger or consolidation hold less than a majority of the issued and outstanding voting equity securities of the successor or surviving person or entity as of immediately following the consummation of such merger or consolidation; (c) a transaction or a series of related transactions in which any “person” or “group” (within the meaning of Section 13(d) and 14(d)(2) of the Securities Exchange Act of 1934, as amended (the "Exchange Act") becomes the “beneficial owner” (as defined in Rule 13d‑3 under the Exchange Act), directly or indirectly, of a sufficient number of shares of all classes of stock then outstanding of the Borrower ordinarily entitled to vote in the election of directors, empowering such “person” or “group” to elect a majority of the Board of Directors of the Borrower, who did not have such power before such transaction; or (d) the closing price per share for the Company’s common stock on the Nasdaq Capital Market being the greater of (i) 70% or more over $7.05, the closing price of the Company’s common stock on March 29, 2018 (after giving effect to any stock splits or consolidations effected after the date thereof) for five successive business days, or (ii) at least 26.13% more than the average price of Company’s common stock for the 365 day period ending on the date of the funding of the Term B Loan. Long-term debt consists of the following at December 31, 2019 and 2018 as follows: December 31, 2019 2018 Principal amount $ 15,000,000 $ 10,000,000 Less unamortized debt acquisition costs (76,718) (105,681) Plus accrued final fee 128,906 46,875 Subtotal 15,052,188 9,941,194 Less current maturities 1,666,666 666,667 Long-term debt net of current maturities $ 13,385,522 $ 9,274,527 Principal payments of long-term debt are due as follows at December 31, 2019: 2020 $ 1,666,666 2021 10,000,000 2022 3,333,334 Total $ 15,000,000 |
LEASES_
LEASES: | 12 Months Ended |
Dec. 31, 2019 | |
LEASES: | |
LEASES: | 8. LEASES: Effective January 1, 2019, the Company adopted the provisions of Accounting Standards Update ("ASU") 2016-02, Leases (Topic 842). The provisions of this ASU require the Company to record a right-of-use asset and related lease liability related to their leases. Accordingly, the Company has adjusted its December 31, 2018 consolidated balance sheet to properly reflect the provisions of this ASU as discussed below. Description of Leases: The Company leases its operating facilities in both the United States and Germany under operating lease agreements. In the United States, in January 2019, the Company entered into an Eighteenth Amendment to Lease with the landlord which became effective February 1, 2019. This amendment expands the Company's space to 19,920 square feet and extends the term of the lease to May 31, 2020. The Company's base rent is approximately $32,000 per month. In addition, the Company is obligated to pay monthly operating expenses of approximately $29,000 per month. The amendment also includes a one year renewal option. The base rent for the renewal term will increase by the greater of five percent or the increase in the Consumer Price Index. There were no lease incentives and no initial direct costs were incurred related to this lease amendment. In Germany, the Company leases its operating facility under two operating lease agreements. These leases require combined base rent payments amounting to approximately $9,000 per month. The initial lease term of both leases ends August 31, 2021. In addition, the Company is obligated to monthly operating expenses of approximately $2,900 per month. Both leases have a five year option to renew that would extend the lease term to August 31, 2026. There are no provisions in the leases to increase the base rent during the renewal period. There were no lease incentives and no initial direct costs were incurred related to these leases. Initial Measurement of Right-Of-Use Asset and Lease Liability: Under the provisions of this ASU, the Company has adjusted its consolidated balance sheet at December 31, 2018 to reflect the value of the right-of-use asset and related lease liability. This value was calculated based on the present value of the remaining base rent lease payments. The remaining lease payments include the renewal periods for both facilities as the Company has determined that it is probable that the renewal options will be exercised under each of the lease agreements. The discount rate used was the Company's incremental borrowing rate, which is 9.16%, as the Company could not determine the rate implicit in the lease. As a result, the value of the right-of-asset and related lease liability is as follows: Year Ended December 31, 2019 2018 Right-of-use asset $ 1,070,762 $ 1,449,437 Total lease liability $ 1,070,762 $ 1,449,437 Less current portion (428,083) (378,675) Lease liability, net of current portion $ 642,679 $ 1,070,762 The maturities of the lease liabilities are as follows as of December 31, 2019: 2020 $ 428,083 2021 233,683 2022 73,609 2023 80,642 2024 88,347 Thereafter 166,398 Total $ 1,070,762 For the years ended December 31, 2019, 2018 and 2017, operating cash flows paid in connection with operating leases amounted to approximately $906,000, $805,000 and $676,000, respectively. As of December 31, 2019 and 2018, the weighted average remaining lease term was 4.0 years and 4.5 years, respectively. |
INCOME TAXES_
INCOME TAXES: | 12 Months Ended |
Dec. 31, 2019 | |
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, 2019, 2018 and 2017 is as follows: Year Ended December 31, 2019 2018 2017 Domestic $ (11,291,799) $ (14,105,664) $ (6,071,009) Foreign (8,436,291) (3,725,061) (3,066,529) Total $ (20,358,090) $ (17,830,725) $ (9,137,538) The benefit from income taxes consists of the following: Year Ended December 31, 2019 2018 2017 State Tax, including sale of New Jersey losses & credits $ 1,092,446 $ 619,546 $ 676,739 Foreign tax provision — — — $ 1,092,446 $ 619,546 $ 676,739 As of December 31, 2019, the Company had federal net operating loss ("NOL") carry forwards of approximately $61.4 million, state NOL carry forwards of approximately $10.0 million, and foreign NOL carry forwards of approximately $24.1 million, which may be available to offset future taxable income, if any. The federal net operating loss carryforwards of $41.4 million, if not utilized, will expire between 2021 and 2037. The federal net operating loss carryforwards of $20.0 million generated since 2018 are subject to an 80% limitation on taxable income, do not expire and will carry forward indefinitely. The state net operating loss carryforwards of $10.0 million, if not utilized, will begin to expire in 2039. As of December 31, 2019, the Company had Federal and state research and development tax credit carryforwards of approximately $1,720,000 and $142,000, 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 expects 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 our 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 our 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 our 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 expects to receive a net cash amount of $1,092,446 from the approved sale of the 2018 state NOL and research and development credits in the first quarter of 2020. The principal components of the Company’s deferred tax assets and liabilities are as follows: Year Ended December 31, 2019 2018 2017 Current and long term deferred tax assets: Net operating loss carry forward $ 20,843,902 $ 16,722,801 $ 12,517,356 Stock Options 329,726 349,810 479,033 Research and development credit carryforward 1,720,558 1,210,153 1,096,308 Accruals and others 56,461 (27,098) 74,477 Lease liability 300,991 — — Gross deferred tax assets 23,251,638 18,255,666 14,167,174 Less valuation allowance (22,857,741) (18,233,810) (14,147,354) 393,897 21,856 19,820 Deferred tax liability: Fixed Assets (393,897) (21,856) (19,820) 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 (decreases) in valuation allowance for the years ended December 31, 2019, 2018 and 2017 were $4,623,930, $4,806,456 and $(3,004,712) 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, 2019 2018 2017 Federal statutory rate 21.0 % 21.0 % 34.0 % State taxes, net of federal benefit (4.4) (2.2) (2.6) Foreign rate differential 3.7 1.9 (1.4) Permanent items (2.0) (2.9) (5.1) Rate change and true-up 8.0 7.6 (62.7) Change in valuation allowance (22.7) (22.9) 44.3 R&D credit 1.8 0.7 0.8 Effective income tax rate 5.4 % 3.2 % 7.3 % |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2019 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 10. COMMITMENTS AND CONTINGENCIES: Employment Agreements On July 30, 2019, CytoSorbents Corporation entered into amended and restated executive employment agreements with its principal executives, Dr. Phillip P. Chan, President and Chief Executive Officer, Vincent Capponi, 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. 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. On May 30, 2017, CytoSorbents Corporation announced the appointment of Dr. Eric R. Mortensen as the Company’s Chief Medical Officer, pursuant to the terms of an employment agreement dated May 23, 2017. Dr. Mortensen’s employment agreement provides for an initial term commencing on June 1, 2017 and ending on December 31, 2019. Dr. Mortensen's contract has not been renewed. 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 Agreements 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, 2019, 2018 and 2017, the Company recorded royalty expenses of approximately $675,000, $600,000 and $393,000 respectively. These expenses are included in selling, general and administrative expenses in the consolidated statements of operations. License Agreements In an agreement dated September 1, 2006, the Company entered into a license agreement which provides the Company the exclusive right to use its patented technology and proprietary know how relating to adsorbent polymers for a period of 18 years. Under the terms of the agreement, the Company has agreed to pay license fees of 2.5% to 5% on the sale of certain of its products if and when those products are sold commercially for a term not greater than 18 years commencing with the first sale of such product. For the years ended December 31, 2019, 2018 and 2017 per the terms of the license agreement, the Company recorded licensing expenses of approximately $1,125,000, $1,002,000 and $655,000 respectively. These expenses are included in selling, general and administrative expenses in the consolidated statements of operations. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2019 | |
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 from 50,000,000 shares authorized to be issued to 100,000,000 shares. Shelf Registration On July 26, 2018, the Company filed a registration statement on Form S‑3 with the SEC (as amended, the “2018 Shelf”). The 2018 Shelf, which was declared effective on August 7, 2018, enables the Company to offer and sell, in one or more offerings, any combination of common stock, preferred stock, senior or subordinated debt securities, warrants and units, up to a total dollar amount of $150 million. Termination of Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. On May 31, 2019, the Company delivered to Cantor Fitzgerald & Co. ("Cantor") written notice of termination (the "Termination Notice") of the Controlled Equity Offering Sales Agreement, dated November 4, 2015, by and between the Company and Cantor, as amended by Amendment No. 1 to Sales Agreement, dated July 26, 2018 (collectively, the "Sales Agreement"). In accordance with Section 13(b) thereof, the Sales Agreement terminated on June 10, 2019, ten (10) days after the delivery of the Termination Notice. As provided in the Sales Agreement, the Sales Agreement terminated without liability of any party to any other party, except that certain provisions of the Sales Agreement identified therein shall remain in full force and effect notwithstanding the termination. Pursuant to the Sales Agreement, the Company offered and sold, from time to time through Cantor, shares of the Company's common stock. In the aggregate, the Company sold 2,094,140 shares pursuant to the Sales Agreement, at an average selling price of $8.72 per share, generating net proceeds of approximately $17,718,000 from November 4, 2015 through December 31, 2018. There were no sales during the year ended December 31, 2019. Open Market Sale Agreement with Jefferies LLC and B. Riley FBR, Inc. On July 9, 2019 the Company entered into an Open Market Sale Agreement (the "New Sale Agreement") with Jefferies LLC and B. Riley FBR, Inc. (each an "Agent" and, together, the "Agents"), pursuant to which the Company may sell, from time to time, at its option, up to an aggregate proceeds of $25,000,000 from shares of the Company’s common stock through the Agents, as the Company’s sales agents. Any shares of the Company's common stock to be offered and sold under the New Sale Agreement will be issued and sold pursuant to the Company’s 2018 Shelf by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, in block transactions or if specified by the Company, in privately negotiated transactions. Subject to the terms of the New Sale Agreement, the Agents will 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 will pay the Agents a commission of up to 3.0% of the gross proceeds from the sale of the shares of the Company's common stock sold thereunder, if any. The Company has also agreed to provide the Agents with customary indemnification rights. The offering of the shares of the Company's common stock will terminate upon the earliest of (a) the sale of the maximum number or amount of the shares of the Company's stock permitted to be sold under the New Sale Agreement and (b) the termination of the New Sale Agreement by the parties thereto. During the year ended December 31, 2019, the Company sold 191,244 shares pursuant to the New Sale Agreement, at an average selling price of $4.11 per share, generating net proceeds of approximately $762,000. During the period from January 1, 2020 through March 2, 2020, the Company sold 2,435,086 shares pursuant to the New Sale Agreement, at an average selling price of $5.64 per share, generating net proceeds of approximately $13,322,000. In the aggregate, the Company has sold 2,626,330 shares pursuant to the New Sale Agreement, at an average selling price of $5.53 per share, generating net proceeds of approximately $14,083,000. Stock Option Plans As of December 31, 2019, 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, 2019, there were outstanding options to purchase approximately 6,100,000 and 743,000 shares 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 yet 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, 2019, 2018 and 2017 amounted to approximately $1,666,000, $4,437,000 and $3,314,000, respectively. These amounts are included in selling, general, and administrative expenses on the consolidated statements of operations. The summary of the stock option activity for the years ended December 31, 2019, 2018 and 2017 is as follows: Weighted Weighted Average Average Remaining Exercise Contractual Shares per Share Life (Years) Outstanding January 1, 2017 2,762,177 $ 4.69 6.0 Granted 1,204,950 $ 5.46 9.2 Forfeited (165,720) $ 5.50 — Expired (34,020) $ 34.61 — Exercised (188,849) $ 4.40 — Outstanding, December 31, 2017 3,578,538 $ 4.64 6.3 Granted 1,481,675 $ 8.01 9.2 Forfeited (544,671) $ 7.49 — Expired (800) $ 2.88 — Exercised (856,280) $ 3.65 — Outstanding, December 31, 2018 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 The fair value of each stock option was estimated using the Black Scholes pricing model which takes into account as of the grant date the exercise price (ranging from $3.84 to $8.25 per share in 2019) and expected life of the stock option (10 years in 2019), the current price of the underlying stock and its expected volatility (ranging from 61.9 to 74.3 percent in 2019), expected dividends (-0- percent) on the stock and the risk free interest rate (1.40 to 2.61 percent) for the term of the stock option. 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, 2019 of $3.85 and the exercise price of the shares. Options Exercisable Number Weighted Exercisable at Average Aggregate December 31, Exercise Intrinsic 2019 Price Value 3,034,399 $ 5.74 $ 212,313 Options Outstanding Number Weighted Weighted Range of Outstanding at Average Average Aggregate Exercise December 31, Exercise Remaining Intrinsic Price 2019 Price Life (Years) Value $2.23 - $14.80 4,218,189 $ 6.16 7.0 $ 212,353 The summary of the status of the Company’s non-vested options for the year ended December 31, 2019 is as follows: Weighted Average Grant Date Shares Fair Value Non-vested, January 1, 2019 1,251,617 $ 4.56 Granted 1,557,300 4.51 Forfeited (716,855) 4. 67 Vested (908,272) 4.47 Non-vested, December 31, 2019 1,183,790 $ 4. 49 As of December 31, 2019, the Company had approximately $3,098,000 of total unrecognized compensation cost related to stock options which will, on average, be amortized over four years. In 2020, the Board of Directors intends to grant a pool of options to purchase 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. Since these options relate exclusively to the achievement of 2020 milestones, no charge for these options has been recorded in the consolidated statements of operations for the year ended December 31, 2019. The Company will assess the likelihood of meeting these milestones throughout 2020 and will record stock option expense as appropriate. Awards of Stock Options: 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 we have recorded approximately $315,000 of stock option expense related to these options for the year ended December 31, 2019. On March 15, 2018, the Board of Directors granted options to purchase 531,900 shares of common stock to the Company’s management. On April 23, 2018, the Board of Directors granted options to purchase 668,550 shares of common stock to the Company’s employees. These grants, which total 1,200,450 shares of common stock, will vest upon the achievement of certain specific, predetermined milestones related to the Company’s 2018 operations. The grant date fair value of these unvested options amounted to approximately $5,636,000. On February 19, 2019, based upon the finalization of its review of the Company's progress to meeting the predetermined milestones for 2018, the Board of Directors determined that 726,920 of these options would immediately vest. Accordingly, a charge of approximately $3,381,000 related to these options has been recorded in the consolidated statements of operations for the year ended December 31, 2018. On February 24, 2017, the Board of Directors granted options to purchase 953,200 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 2017 operations. The grant date fair value of these unvested options amounted to approximately $3,284,000. On February 15, 2018, based upon the finalization of its review of the Company’s progress to meeting the predetermined milestones for 2017, the Board of Directors determined that 810,220 of these options would immediately vest. Accordingly, a charge of approximately $2,791,000 related to these options has been recorded in the consolidated statements of operations for the year ended December 31, 2017. 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, 2017 264,000 675,300 815,700 1,755,000 Granted 2018 13,200 49,200 256,350 318,750 Forfeited 2018 — (69,750) (69,750) December 31, 2018 277,200 724,500 1,002,300 2,004,000 $ 16,192,320 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 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, 2019. Performance Based Stock Awards: Pursuant to a review of the compensation of the senior management of the Company and managements’ performance in 2016, on February 24, 2017, the Board of Directors granted 125,000 restricted stock units to certain senior managers of the Company in order to settle bonuses accrued as of December 31, 2016. These awards were valued at approximately $700,000 on the date of issuance, based upon the market price of the Company’s common stock at the date of the grant, and vest one third on the date of the grant, one third on the first anniversary of the grant, and one third on the second anniversary of the date of the grant. For the years ended December 31, 2019, 2018 and 2017, the Company recorded a charge of approximately $150,000, $329,000, and $201,000, respectively related to these restricted stock unit awards. Pursuant to a review of the compensation of the senior management of the Company and managements’ performance in 2017, on February 28, 2018, the Board of Directors granted 146,200 restricted stock units to certain senior managers of the Company in order to settle bonuses accrued as of December 31, 2017. These awards were valued at approximately $1,148,000 at the date of issuance, based upon the market price of the Company’s common stock at the date of the grant, and vest one third on the date of the grant, one third on the first anniversary of the grant, and one third on the second anniversary of the date of the grant. For the years ended December 31, 2019, 2018 and 2017, the Company recorded a charge of approximately $363,000, $319,000, and $383,000, respectively related to these restricted stock unit awards. Pursuant to a review of the compensation of the senior management of the Company and managements' performance in 2018, on March 4, 2019 the Board of Directors granted 22,220 restricted stock units to certain senior managers of the Company in order to settle bonuses accrued as of December 31, 2018. These awards were valued at approximately $179,000 at the date of issuance, based upon the market price of the Company's common stock at the date of the grant, and vest one third on the date of the grant, one third on the first anniversary of the date of the grant, and one third on the second anniversary of the date of the grant. For the years ended December 31, 2019, the Company recorded a charge of approximately $39,000 related to these restricted stock unit awards. Pursuant to a review of the compensation of the senior management of the Company and managements' performance in 2019, on July 22, 2019 the Board of Directors granted 180,300 restricted stock units to certain senior managers of the Company. These awards were valued at approximately $1,300,000 at the date of issuance, based upon the market price of the Company's common stock at the date of the grant, and vest one third on the date of the grant, one third on the first anniversary of the date of the grant, and one third on the second anniversary of the date of the grant. For the years ended December 31, 2019, the Company recorded a charge of approximately $621,000 related to these restricted stock unit awards. The following table outlines the restricted stock unit activity for the year ended December 31, 2019: Weighted Average Grant Date Shares Fair Value Non-vested, January 1, 2019 139,138 $ 7.18 Granted 202,520 $ 7.41 Forfeited (15,882) $ 7.62 Vested (157,904) $ 7.07 Non-vested, December 31, 2019 167,872 $ 7.52 Warrants: As of December 31, 2019, the Company has warrants outstanding to purchase 30,000 shares of the Company's common stock. These warrants had an exercise price of $9.90 and expired on January 14, 2020. During the year ended December 31, 2019, warrants representing 369,387 shares of the Company’s common stock were exercised. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 12 Months Ended |
Dec. 31, 2019 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | 12. NET LOSS PER SHARE Basic earnings per share and diluted earnings per share for the years ended December 31, 2019, 2018 and 2017 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 6,503,000, 6,232,000, and 6,326,000 incremental shares at December 31, 2019, 2018 and 2017, respectively, have been excluded from the computation of diluted loss per share as they are anti-dilutive. |
RETIREMENT PLAN
RETIREMENT PLAN | 12 Months Ended |
Dec. 31, 2019 | |
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 full months of employment. Participants may defer up to 100% of their eligible compensation subject to certain IRC limitations. In addition, the Company provides for a matching contribution of twenty percent of the participants’ contribution on a maximum of a five percent compensation contribution. Matching contributions amounted to approximately $43,800, $43,600 and $41,700 for the years ended December 31, 2019, 2018 and 2017, respectively. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2019 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | 14. SUBSEQUENT EVENT During the period from January 1, 2020 through March 2, 2020, the Company sold 2,435,086 shares pursuant to the Open Market Sale Agreement with Jefferies LLC and B. Riley FBR, Inc., at an average selling price of $5.64 per share, generating net proceeds of approximately $13,322,000 (see Note 11). |
QUARTERLY FINANCIAL RESULTS (UN
QUARTERLY FINANCIAL RESULTS (UNAUDITED) | 12 Months Ended |
Dec. 31, 2019 | |
QUARTERLY FINANCIAL RESULTS (UNAUDITED) | |
QUARTERLY FINANCIAL RESULTS (UNAUDITED) | 15. QUARTERLY FINANCIAL RESULTS (UNAUDITED) Summarized quarterly data for 2019, 2018 and 2017 are as follows: For the Quarters Ended March 31 June 30 September 30 December 31 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) 2018: Total revenue $ 4,924,651 5,755,438 5,742,975 6,080,844 Gross margin 3,357,006 3,969,584 3,690,278 3,997,640 Loss from operations (3,101,167) (4,187,875) (2,710,620) (5,585,266) Net loss attributable to common stockholders (2,982,035) (5,821,202) (3,004,764) (5,403,178) Net loss per share, basic and diluted (0.10) (0.19) (0.10) (0.17) 2017: Total revenue $ 3,113,518 3,566,226 3,824,299 4,646,711 Gross margin 1,859,035 2,084,216 2,307,435 3,381,708 Loss from operations (1,557,478) (2,330,908) (2,149,045) (3,805,167) Net loss attributable to common stockholders (1,524,873) (2,070,359) (2,054,279) (3,147,019) Net loss per share, basic and diluted (0.06) (0.07) (0.07) (0.12) |
PRINCIPAL BUSINESS ACTIVITY A_2
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: | |
Nature of Business | Nature of Business The Company is a critical care immunotherapy leader commercializing its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world. The Company, through its subsidiary CytoSorbents Medical, Inc. (formerly known as CytoSorbents, Inc.), is engaged in the research, development and commercialization of medical devices with its blood purification technology platform which incorporates a proprietary adsorbent, porous polymer technology. The Company, through its wholly owned European subsidiary, CytoSorbents Europe GmbH, conducts sales and marketing related operations for the Company's flagship product, CytoSorb. In March 2016, the Company formed CytoSorbents Switzerland GmbH, a wholly-owned subsidiary of CytoSorbents Europe GmbH. This subsidiary, which began operations during the second quarter of 2016, provides marketing and direct sales services in Switzerland. In November 2018, the Company formed CytoSorbents Poland Sp. z.o.o., a wholly-owned subsidiary of CytoSorbents Europe GmbH. This subsidiary, which began operations during the first quarter of 2019, provides marketing and direct sales services in Poland. In the third quarter of 2019, the Company formed CytoSorbents UK Limited, a wholly-owned subsidiary of CytoSorbents Medical, Inc. which is responsible for the management of our clinical trial activities in the United Kingdom. CytoSorb was approved in the European Union (“EU”) in March 2011, and is currently being distributed in fifty-eight countries around the world, as a safe and effective extracorporeal cytokine absorber, designed to reduce the “cytokine storm” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. In May 2018, the Company received a label extension for CytoSorb covering use of the device for the removal of bilirubin and myoglobin which allows for the use of the device in the treatment of liver failure and trauma, respectively. In January 2020, the Company received a label extension for CytoSorb covering the use of the device for the removal the anti-platelet agent, ticagrelor, in cardiac patients during surgery requiring cardiopulmonary bypass. CytoSorb is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. The Company's 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 absorption. 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, and others. These patents and patent applications are directed to various compositions and methods of use related to our blood purification technologies. The existing patents are scheduled to expire between 2020 and 2035, absent any patent term extensions. Management believes that any near term expiring patents will not have a significant impact on our ongoing business. |
Stock Market Listing | 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 $(350,000), $(785,000) and $1,454,000 for the years ended December 31, 2019, 2018 and 2017, 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 stockholder’s 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. |
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 written off to 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, 2019 and 2018, the Company’s inventory was comprised of finished goods, which amounted to $305,452 and $213,839, respectively, work in process which amounted to $1,523,923 and $415,265, respectively and raw materials which amounted to $284,522 and $204,029, 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: Revenues from sales of products to both direct and distributor/strategic partner customers are recognized at the time when control passes to the customer, in accordance with the terms of their respective contracts. Recognition of revenue occurs as each performance obligation is completed. Grant Revenue : Revenue from grant income is based on contractual agreements. Certain agreements provide for reimbursement of costs, other agreements provide for reimbursement of costs and an overhead margin and certain agreements are performance based, where revenue is earned based upon the achievement of milestones outlined in the contract. Revenues are recognized when the associated performance obligation is fulfilled. Costs are recorded as incurred. Costs subject to reimbursement by these grants have been reflected as costs of revenue. |
Research and Development | 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 $314,000, $212,000 and $162,000 in 2019, 2018 and 2017, respectively, and is included in selling, general, and administrative expenses on the consolidated statements of operations. |
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 (the “Act”) was enacted on December 22, 2017. The Act reduces 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, 2019 or 2018. 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 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. Significant estimates in these financials are the valuation of options granted and valuation methods used to determine the change in fair value of the down round feature related to certain of the Company’s outstanding warrants. |
Concentration of Credit Risk | Concentration of Credit Risk The Company maintains cash balances, at times, with financial institutions in excess of amounts insured by the Federal Deposit Insurance Corporation. Management monitors the soundness of these institutions in an effort to minimize its collection risk of these balances. A significant portion of our revenues are from product sales in Germany. Substantially all of our grant and other income are from grant agencies in the United States. (See Note 3 for further information relating to the Company’s revenue.) As of December 31, 2019, no agency, distributor/strategic partners or direct customer represented more than 10% of outstanding grants and accounts receivables. As of December 31, 2018, two distributors/strategic partners accounted for 29 percent of the outstanding grants and accounts receivables. For the years ended December 31, 2019, 2018 and 2017, 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 other debt obligations approximate their fair values due to their short-term nature. |
Net Loss Per Common Share | Net Loss per Common Share Basic earnings per share is computed by dividing loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per common share is computed using the treasury stock method on the basis of the weighted-average number of shares of common stock plus the dilutive effect of potential common shares outstanding during the period. Dilutive potential common shares include outstanding warrants, stock options and restricted shares. The computation of diluted earnings per share does not assume conversion, exercise or contingent exercise of securities that would have an anti-dilutive effect on earnings (See Note 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 | Effects of Recent Accounting Pronouncements In February 2016, the FASB issued ASU 2016‑02, “Leases (Topic 842)”. ASU 2016‑02 outlines reporting requirements for lessees to recognize a right-of-use asset and corresponding liability on the balance sheet for all leases covering a period of greater than 12 months. The liability is to be measured as the present value of the future minimum lease payments, plus any initial direct costs. The minimum payments are discounted using the rate implicit in the lease, or, if not known, the lessee’s incremental borrowing rate. The updated guidance is effective for public entities for fiscal years beginning after December 31, 2018. The Company adopted the updated guidance effective January 1, 2019. See Note 8 for details regarding the Company's leases. |
Shipping and Handling Costs | S hipping 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 $476,000, $424,000 and $257,000 for the years ended December 31, 2019, 2018 and 2017, respectively. |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
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, 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 following table disaggregates the Company’s revenue by customer type and geographic area for the year ended December 31, 2018: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 95,500 $ — $ — $ 95,500 Germany 11,771,645 — — 11,771,645 All other countries 2,702,689 5,682,549 — 8,385,238 Total product revenue 14,569,834 5,682,549 — 20,252,383 Grant and other income: United States — — 2,251,525 2,251,525 Total revenue $ 14,569,834 $ 5,682,549 $ 2,251,525 $ 22,503,908 The following table disaggregates the Company’s revenue by customer type and geographic area for the year ended December 31, 2017: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 126,900 $ — $ — $ 126,900 Germany 7,906,851 — — 7,906,851 All other countries 1,771,144 3,576,958 — 5,348,102 Total product revenue 9,804,895 3,576,958 — 13,381,853 Grant and other income: United States — — 1,768,901 1,768,901 Total revenue $ 9,804,895 $ 3,576,958 $ 1,768,901 $ 15,150,754 |
Schedule of contract with Customer, Asset and Liability | December 31, 2019 December 31, 2018 Receivables, which are included in grants and accounts receivable $ 2,246,821 $ 2,399,662 Contract liabilities, which are included in accrued expenses and other current liabilities $ 171,842 $ 42,219 |
PROPERTY AND EQUIPMENT, NET_ (T
PROPERTY AND EQUIPMENT, NET: (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
PROPERTY AND EQUIPMENT, NET: | |
Schedule of Property and Equipment, Net | Depreciation/ Amortization December 31, 2019 2018 Period Furniture and fixtures $ 795,167 $ 621,702 7 years Equipment and computers 3,861,912 3,340,282 3 to 7 years Leasehold improvements 927,894 942,228 Lesser of term of lease or estimated useful life 5,584,973 4,904,212 Less accumulated depreciation and amortization 3,659,648 3,174,352 Property and Equipment, Net $ 1,925,325 $ 1,729,860 |
OTHER ASSETS_ (Tables)
OTHER ASSETS: (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
OTHER ASSETS: | |
Schedule of Other Assets | December 31, 2019 2018 Patents $ 3,751,468 $ 2,929,517 Less accumulated amortization (390,056) (304,252) Patents, net 3,361,412 2,625,265 Security deposits 123,482 128,114 Total $ 3,484,894 $ 2,753,379 |
ACCRUED EXPENSES AND OTHER CU_2
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: | |
Schedule of accrued expenses and other current liabilities | December 31, 2019 2018 Accrued salaries and commissions $ 1,926,167 $ 1,840,457 Clinical studies 1,384,564 822,085 Accrued accounts payable 629,186 479,783 Accrued royalties 525,004 433,589 Sales, payroll and income taxes payable 402,816 182,753 Professional fees 394,088 280,381 Travel and entertainment 214,436 187,047 Customer rebates 157,656 — Interest 108,629 76,726 Board of Director fees 59,750 31,350 Congresses — 51,549 $ 5,802,296 $ 4,385,720 |
LONG-TERM DEBT (Tables)
LONG-TERM DEBT (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
LONG-TERM DEBT | |
Schedule of Long-term Debt | December 31, 2019 2018 Principal amount $ 15,000,000 $ 10,000,000 Less unamortized debt acquisition costs (76,718) (105,681) Plus accrued final fee 128,906 46,875 Subtotal 15,052,188 9,941,194 Less current maturities 1,666,666 666,667 Long-term debt net of current maturities $ 13,385,522 $ 9,274,527 |
Schedule of Principal payments of long-term debt | 2020 $ 1,666,666 2021 10,000,000 2022 3,333,334 Total $ 15,000,000 |
LEASES_ (Tables)
LEASES: (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
LEASES: | |
Schedule Of Right-Of-Asset And Related Lease Liability | As a result, the value of the right-of-asset and related lease liability is as follows: Year Ended December 31, 2019 2018 Right-of-use asset $ 1,070,762 $ 1,449,437 Total lease liability $ 1,070,762 $ 1,449,437 Less current portion (428,083) (378,675) Lease liability, net of current portion $ 642,679 $ 1,070,762 |
Schedule of Maturities of Lease Liabilities | The maturities of the lease liabilities are as follows as of December 31, 2019: 2020 $ 428,083 2021 233,683 2022 73,609 2023 80,642 2024 88,347 Thereafter 166,398 Total $ 1,070,762 |
INCOME TAXES_ (Tables)
INCOME TAXES: (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
INCOME TAXES: | |
Schedule of Income before Income Tax, Domestic and Foreign | Year Ended December 31, 2019 2018 2017 Domestic $ (11,291,799) $ (14,105,664) $ (6,071,009) Foreign (8,436,291) (3,725,061) (3,066,529) Total $ (20,358,090) $ (17,830,725) $ (9,137,538) |
Schedule of Components of Income Tax Expense (Benefit) | Year Ended December 31, 2019 2018 2017 State Tax, including sale of New Jersey losses & credits $ 1,092,446 $ 619,546 $ 676,739 Foreign tax provision — — — $ 1,092,446 $ 619,546 $ 676,739 |
Schedule of Deferred Tax Assets and Liabilities | Year Ended December 31, 2019 2018 2017 Current and long term deferred tax assets: Net operating loss carry forward $ 20,843,902 $ 16,722,801 $ 12,517,356 Stock Options 329,726 349,810 479,033 Research and development credit carryforward 1,720,558 1,210,153 1,096,308 Accruals and others 56,461 (27,098) 74,477 Lease liability 300,991 — — Gross deferred tax assets 23,251,638 18,255,666 14,167,174 Less valuation allowance (22,857,741) (18,233,810) (14,147,354) 393,897 21,856 19,820 Deferred tax liability: Fixed Assets (393,897) (21,856) (19,820) Net deferred tax assets $ — $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation | Year Ended December 31, 2019 2018 2017 Federal statutory rate 21.0 % 21.0 % 34.0 % State taxes, net of federal benefit (4.4) (2.2) (2.6) Foreign rate differential 3.7 1.9 (1.4) Permanent items (2.0) (2.9) (5.1) Rate change and true-up 8.0 7.6 (62.7) Change in valuation allowance (22.7) (22.9) 44.3 R&D credit 1.8 0.7 0.8 Effective income tax rate 5.4 % 3.2 % 7.3 % |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
STOCKHOLDERS' EQUITY | |
Schedule Of Share Based Compensation Stock Options Activity | Weighted Weighted Average Average Remaining Exercise Contractual Shares per Share Life (Years) Outstanding January 1, 2017 2,762,177 $ 4.69 6.0 Granted 1,204,950 $ 5.46 9.2 Forfeited (165,720) $ 5.50 — Expired (34,020) $ 34.61 — Exercised (188,849) $ 4.40 — Outstanding, December 31, 2017 3,578,538 $ 4.64 6.3 Granted 1,481,675 $ 8.01 9.2 Forfeited (544,671) $ 7.49 — Expired (800) $ 2.88 — Exercised (856,280) $ 3.65 — Outstanding, December 31, 2018 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 |
Schedule of Share-based Compensation, Shares Authorized under Stock Option Plans, by Exercise Price Range | Options Exercisable Number Weighted Exercisable at Average Aggregate December 31, Exercise Intrinsic 2019 Price Value 3,034,399 $ 5.74 $ 212,313 Options Outstanding Number Weighted Weighted Range of Outstanding at Average Average Aggregate Exercise December 31, Exercise Remaining Intrinsic Price 2019 Price Life (Years) Value $2.23 - $14.80 4,218,189 $ 6.16 7.0 $ 212,353 |
Schedule Of Nonvested Share Activity | Weighted Average Grant Date Shares Fair Value Non-vested, January 1, 2019 1,251,617 $ 4.56 Granted 1,557,300 4.51 Forfeited (716,855) 4. 67 Vested (908,272) 4.47 Non-vested, December 31, 2019 1,183,790 $ 4. 49 |
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | Board of Executive Other Directors Management Employees Total Intrinsic Value December 31, 2017 264,000 675,300 815,700 1,755,000 Granted 2018 13,200 49,200 256,350 318,750 Forfeited 2018 — (69,750) (69,750) December 31, 2018 277,200 724,500 1,002,300 2,004,000 $ 16,192,320 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 |
Schedule Of Restricted Stock Unit Activity | Weighted Average Grant Date Shares Fair Value Non-vested, January 1, 2019 139,138 $ 7.18 Granted 202,520 $ 7.41 Forfeited (15,882) $ 7.62 Vested (157,904) $ 7.07 Non-vested, December 31, 2019 167,872 $ 7.52 |
QUARTERLY FINANCIAL RESULTS (_2
QUARTERLY FINANCIAL RESULTS (UNAUDITED) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
QUARTERLY FINANCIAL RESULTS (UNAUDITED) | |
Summarized quarterly information | For the Quarters Ended March 31 June 30 September 30 December 31 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) 2018: Total revenue $ 4,924,651 5,755,438 5,742,975 6,080,844 Gross margin 3,357,006 3,969,584 3,690,278 3,997,640 Loss from operations (3,101,167) (4,187,875) (2,710,620) (5,585,266) Net loss attributable to common stockholders (2,982,035) (5,821,202) (3,004,764) (5,403,178) Net loss per share, basic and diluted (0.10) (0.19) (0.10) (0.17) 2017: Total revenue $ 3,113,518 3,566,226 3,824,299 4,646,711 Gross margin 1,859,035 2,084,216 2,307,435 3,381,708 Loss from operations (1,557,478) (2,330,908) (2,149,045) (3,805,167) Net loss attributable to common stockholders (1,524,873) (2,070,359) (2,054,279) (3,147,019) Net loss per share, basic and diluted (0.06) (0.07) (0.07) (0.12) |
BASIS OF PRESENTATION (Details)
BASIS OF PRESENTATION (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
BASIS OF PRESENTATION | |||
Accumulated deficit | $ (188,789,459) | $ (169,523,815) | |
Net loss | $ (19,265,644) | $ (17,211,179) | $ (8,460,799) |
PRINCIPAL BUSINESS ACTIVITY A_3
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: - Additional information (Details) | 12 Months Ended | ||
Dec. 31, 2019USD ($)item | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||
Number of Countries Where Flagship Product is Marketed and Distributed | item | 58 | ||
Number of Patents, United States | item | 21 | ||
Inventory, Finished Goods, Gross | $ 305,452 | $ 213,839 | |
Inventory, Work in Process, Gross | 1,523,923 | 415,265 | |
Inventory, Raw Materials, Gross | 284,522 | 204,029 | |
Advertising Expense | $ 314,000 | $ 212,000 | $ 162,000 |
Concentration Risk, Percentage | 0.00% | 0.00% | 0.00% |
Cost of Goods and Services Sold | $ 7,363,919 | $ 7,489,400 | $ 5,518,360 |
Unrecognized Tax Benefits | $ 0 | $ 0 | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 21.00% | 34.00% |
Federal | |||
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 Goods and Services Sold | $ 476,000 | $ 424,000 | $ 257,000 |
Accounts Receivable | |||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||
Concentration Risk, Percentage | 10.00% | ||
Accounts Receivable | two distributors/strategic partners | |||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||
Concentration Risk, Percentage | 29.00% | ||
Sales Revenue, Net | |||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||
Concentration Risk, Percentage | 10.00% | 10.00% | 10.00% |
Revenue - Revenue by customer t
Revenue - Revenue by customer type and geographic area (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Product sales: | |||||||||||||||
Total revenue | $ 7,430,311 | $ 6,095,007 | $ 6,232,526 | $ 5,191,629 | $ 6,080,844 | $ 5,742,975 | $ 5,755,438 | $ 4,924,651 | $ 4,646,711 | $ 3,824,299 | $ 3,566,226 | $ 3,113,518 | $ 24,949,473 | $ 22,503,908 | $ 15,150,754 |
Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 22,765,854 | 20,252,383 | 13,381,853 | ||||||||||||
Grant | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 2,183,619 | 2,251,525 | 1,768,901 | ||||||||||||
United States | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 220,100 | 95,500 | 126,900 | ||||||||||||
United States | Grant | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 2,183,619 | 2,251,525 | 1,768,901 | ||||||||||||
Germany | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 14,396,418 | 11,771,645 | 7,906,851 | ||||||||||||
All Other Countries | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 8,149,336 | 8,385,238 | 5,348,102 | ||||||||||||
Direct | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 17,764,047 | 14,569,834 | 9,804,895 | ||||||||||||
Direct | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 17,764,047 | 14,569,834 | 9,804,895 | ||||||||||||
Direct | United States | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 220,100 | 95,500 | 126,900 | ||||||||||||
Direct | United States | Grant | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 0 | 0 | 0 | ||||||||||||
Direct | Germany | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 14,396,418 | 11,771,645 | 7,906,851 | ||||||||||||
Direct | All Other Countries | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 3,147,529 | 2,702,689 | 1,771,144 | ||||||||||||
Distributors/Strategic Partners | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 5,001,807 | 5,682,549 | 3,576,958 | ||||||||||||
Distributors/Strategic Partners | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 5,001,807 | 5,682,549 | 3,576,958 | ||||||||||||
Distributors/Strategic Partners | United States | Product | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 0 | 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 | 5,001,807 | 5,682,549 | 3,576,958 | ||||||||||||
United States Government Agencies | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 2,183,619 | 2,251,525 | 1,768,901 | ||||||||||||
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 | |||||||||||||
United States Government Agencies | United States | Grant | |||||||||||||||
Product sales: | |||||||||||||||
Total revenue | 2,183,619 | 2,251,525 | 1,768,901 | ||||||||||||
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, 2019 | Dec. 31, 2018 |
Revenue | ||
Receivables, which are included in grants and accounts receivable | $ 2,246,821 | $ 2,399,662 |
Contract liabilities, which are included in accrued expenses and other current liabilities | $ 171,842 | $ 42,219 |
Revenue - Additional informatio
Revenue - Additional information (Details) | 12 Months Ended |
Dec. 31, 2019item | |
Number of primary revenue streams | 2 |
Term Of Customer Contracts | 3 years |
Maximum | |
Term Of Customer Contracts | 5 years |
Minimum | |
Term Of Customer Contracts | 1 year |
PROPERTY AND EQUIPMENT, NET_ (D
PROPERTY AND EQUIPMENT, NET: (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment | $ 5,584,973 | $ 4,904,212 |
Less accumulated depreciation and amortization | 3,659,648 | 3,174,352 |
Property, Plant and Equipment, Net, Total | 1,925,325 | 1,729,860 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment | $ 795,167 | 621,702 |
Property, Plant and Equipment, Useful Life | 7 years | |
Equipment and computers | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment | $ 3,861,912 | 3,340,282 |
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 | $ 927,894 | $ 942,228 |
PROPERTY AND EQUIPMENT, NET_ -
PROPERTY AND EQUIPMENT, NET: - Additional information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
PROPERTY AND EQUIPMENT, NET: | |||
Depreciation | $ 495,728 | $ 329,469 | $ 177,776 |
OTHER ASSETS_ (Details)
OTHER ASSETS: (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
OTHER ASSETS: | ||
Patents | $ 3,751,468 | $ 2,929,517 |
Less accumulated amortization | (390,056) | (304,252) |
Patents, net | 3,361,412 | 2,625,265 |
Security deposits | 123,482 | 128,114 |
Other Assets, Noncurrent, Total | $ 3,484,894 | $ 2,753,379 |
OTHER ASSETS_ - Additional info
OTHER ASSETS: - Additional information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
OTHER ASSETS: | |||
2020 | $ 94,300 | ||
2021 | 92,200 | ||
2022 | 88,900 | ||
2023 | 85,600 | ||
2024 | 85,600 | ||
Amortization expense | $ 85,804 | $ 61,082 | $ 40,495 |
ACCRUED EXPENSES AND OTHER CU_3
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: | ||
Accrued salaries and commissions | $ 1,926,167 | $ 1,840,457 |
Clinical studies | 1,384,564 | 822,085 |
Accrued accounts payable | 629,186 | 479,783 |
Accrued royalties | 525,004 | 433,589 |
Sales, payroll and income taxes payable | 402,816 | 182,753 |
Professional fees | 394,088 | 280,381 |
Travel and entertainment | 214,436 | 187,047 |
Customer Rebates | 157,656 | |
Interest | 108,629 | 76,726 |
Board of director fees | 59,750 | 31,350 |
Congresses | 51,549 | |
Accrued Expenses And Other Current Liabilities | $ 5,802,296 | $ 4,385,720 |
LONG-TERM DEBT - Letter success
LONG-TERM DEBT - Letter success fee (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
LONG-TERM DEBT | ||
Principal amount | $ 15,000,000 | $ 10,000,000 |
Less unamortized debt acquisition costs | (76,718) | (105,681) |
Plus accrued final fee | 128,906 | 46,875 |
Subtotal | 15,052,188 | 9,941,194 |
Less Current maturities | (1,666,666) | (666,667) |
Long-term debt net of current maturities | $ 13,385,522 | $ 9,274,527 |
LONG-TERM DEBT - Principal paym
LONG-TERM DEBT - Principal payments (Details) | Dec. 31, 2019USD ($) |
LONG-TERM DEBT | |
2020 | $ 1,666,666 |
2021 | 10,000,000 |
2022 | 3,333,334 |
Total | $ 15,000,000 |
LONG-TERM DEBT - Additional inf
LONG-TERM DEBT - Additional information (Details) - USD ($) | Jul. 31, 2019 | Mar. 29, 2018 | May 23, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Mar. 02, 2020 | Jun. 30, 2016 |
Debt Issuance Costs, Net | $ 76,718 | $ 105,681 | ||||||
Share Price | $ 5.53 | |||||||
Long-term Debt | $ 15,052,188 | 9,941,194 | ||||||
Stock Issued During Period, Shares, Other | 68,791 | |||||||
Other Noncash Expense | $ 637,000 | $ 0 | 637,000 | $ 0 | ||||
Maximum period for release of attachment or seizure of assets per debt agreement | 10 days | |||||||
Maximum period for dismissal or stay of insolvency proceedings per debt agreement | 30 days | |||||||
Term A Loan | ||||||||
Debt Instrument, Interest Rate, Effective Percentage | 9.10% | |||||||
Non refundable Closing Fee | ||||||||
Interest Expense, Debt | $ 33,175 | 31,946 | 29,971 | |||||
Non refundable Final Fee | ||||||||
Non-refundable fee percent | 2.50% | |||||||
Interest Expense, Debt | $ 82,031 | $ 65,104 | $ 52,083 | |||||
Western Alliance Bank | ||||||||
Debt Instrument, Face Amount | $ 15,000,000 | $ 10,000,000 | ||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.41% | |||||||
Debt Issuance Costs, Net | $ 90,925 | |||||||
Term Loan Interest LIBRO Rate Adjusted Monthly | 3.66% | |||||||
Western Alliance Bank | First Anniversary | ||||||||
Debt Instrument, Periodic Payment | $ 833,333 | |||||||
Percentage Of Prepayment Interest | 2.00% | |||||||
Western Alliance Bank | Second Anniversary | ||||||||
Percentage Of Prepayment Interest | 1.50% | |||||||
Western Alliance Bank | Third Anniversary | ||||||||
Percentage Of Prepayment Interest | 1.00% | |||||||
Western Alliance Bank | Closing Fee | ||||||||
Debt Issuance Costs, Net | $ 25,000 | |||||||
Western Alliance Bank | Bank Related Expenses | ||||||||
Debt Issuance Costs, Net | 11,000 | |||||||
Western Alliance Bank | Legal Expenses | ||||||||
Debt Issuance Costs, Net | 20,050 | |||||||
Long-term Debt | 85,938 | |||||||
Western Alliance Bank | Term A Loan | ||||||||
Debt Instrument, Face Amount | 10,000,000 | $ 5,000,000 | ||||||
Western Alliance Bank | Term B Loan | ||||||||
Debt Instrument, Face Amount | $ 5,000,000 | |||||||
Repayments of Debt | $ 5,000,000 | |||||||
Long-term Debt | $ 15,000,000 | |||||||
Western Alliance Bank | Term B Loan | First Anniversary | ||||||||
Debt Instrument, Periodic Payment | $ 625,000 | |||||||
Western Alliance Bank | 2016 Success Fee Letter | ||||||||
Percentage Of Success Fee | 6.37% | |||||||
Share Price | $ 8 | |||||||
Number of days for stock price threshold set in success fee letter | 5 days | |||||||
Western Alliance Bank | 2018 Success Fee Letter | ||||||||
Percentage Of Success Fee | 6.37% | |||||||
Share 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% | |||||||
Western Alliance Bank - First Amendment | Legal Expenses | ||||||||
Debt Issuance Costs, Net | $ 4,212 | |||||||
Subsequent event | ||||||||
Share Price | $ 5.64 |
LEASES_ - ROU and Lease liabili
LEASES: - ROU and Lease liability (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
LEASES: | ||
Right of use asset | $ 1,070,762 | $ 1,449,437 |
Total lease liability | 1,070,762 | 1,449,437 |
Less current portion | (428,083) | (378,675) |
Lease liability, net of current portion | $ 642,679 | $ 1,070,762 |
LEASES_ - Maturities of Lease l
LEASES: - Maturities of Lease liabilities (Details) | Dec. 31, 2019USD ($) |
LEASES: | |
2020 | $ 428,083 |
2021 | 233,683 |
2022 | 73,609 |
2023 | 80,642 |
2024 | 88,347 |
Thereafter | 166,398 |
Total | $ 1,070,762 |
LEASES_ - Additional Informatio
LEASES: - Additional Information (Details) | 12 Months Ended | |||
Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Feb. 01, 2019ft² | |
Lessee, Operating Lease, Discount Rate | 9.16% | |||
Operating Lease, Payments | $ 906,000 | $ 805,000 | $ 676,000 | |
Operating Lease, Weighted Average Remaining Lease Term | 4 years | 4 years 6 months | ||
United States | ||||
Area of Land | ft² | 19,920 | |||
Operating Leases, Rent Expense, Net | $ 32,000 | |||
Additional Operating Leases Rent Expense Net | 29,000 | |||
Germany | ||||
Operating Leases, Rent Expense, Net | 9,000 | |||
Additional Operating Leases Rent Expense Net | $ 2,900 |
INCOME TAXES_ - Consolidated lo
INCOME TAXES: - Consolidated loss before income taxes (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
INCOME TAXES: | |||
Domestic | $ (11,291,799) | $ (14,105,664) | $ (6,071,009) |
Foreign | (8,436,291) | (3,725,061) | (3,066,529) |
Total | $ (20,358,090) | $ (17,830,725) | $ (9,137,538) |
INCOME TAXES_ - The benefit fro
INCOME TAXES: - The benefit from income taxes (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
INCOME TAXES: | |||
State Tax, including sale of New Jersey losses & credits | $ 1,092,446 | $ 619,546 | $ 676,739 |
Income Tax Expenase (Benefit), Total | $ 1,092,446 | $ 619,546 | $ 676,739 |
INCOME TAXES_ - The principal c
INCOME TAXES: - The principal components of the Company's deferred tax assets and liabilities (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Current and long term deferred tax assets: | |||
Net operating loss carryforward | $ 20,843,902 | $ 16,722,801 | $ 12,517,356 |
Research and development credit carryforward | 1,720,558 | 1,210,153 | 1,096,308 |
Accruals and others | 56,461 | (27,098) | 74,477 |
Lease liability | 300,991 | ||
Gross deferred tax assets | 23,251,638 | 18,255,666 | 14,167,174 |
Less valuation allowance | (22,857,741) | (18,233,810) | (14,147,354) |
Deferred Tax Assets, Net of Valuation Allowance | 393,897 | 21,856 | 19,820 |
Deferred tax liability: | |||
Fixed Assets | (393,897) | (21,856) | (19,820) |
Net deferred tax assets | 0 | 0 | 0 |
Option | |||
Current and long term deferred tax assets: | |||
Stock Options | $ 329,726 | $ 349,810 | $ 479,033 |
INCOME TAXES_ - Reconciliation
INCOME TAXES: - Reconciliation of income tax (expense) benefit (Details) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Holiday [Line Items] | |||
Federal statutory rate | 21.00% | 21.00% | 34.00% |
State taxes, net of federal benefit | (4.40%) | (2.20%) | (2.60%) |
Foreign rate differential | 3.70% | 1.90% | (1.40%) |
Permanent items | (2.00%) | (2.90%) | (5.10%) |
Rate change and true-up | 8.00% | 7.60% | (62.70%) |
Change in valuation allowance | (22.70%) | (22.90%) | 44.30% |
R&D credit | 1.80% | 0.70% | 0.80% |
Effective income tax rate | 5.40% | 3.20% | 7.30% |
Federal | |||
Income Tax Holiday [Line Items] | |||
Federal statutory rate | 21.00% | 35.00% |
INCOME TAXES_ - Additional info
INCOME TAXES: - Additional information (Details - USD ($) | 12 Months Ended | ||
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 | $ 1,092,446 | ||
Net operating loss carry forwards | 41,400,000 | ||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | $ 4,623,930 | $ 4,806,456 | $ (3,004,712) |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 21.00% | 34.00% |
Operating Loss Carryforwards, Limitations on Use | 80% limitation on taxable income | ||
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry forwards | $ 61,400,000 | $ 20,000,000 | |
Tax Credit Carryforward, Amount | $ 1,720,000 | ||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 35.00% | |
State | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry forwards | $ 10,000,000 | ||
Tax Credit Carryforward, Amount | 142,000 | ||
Foreign Tax Authority | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry forwards | $ 24,100,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) - USD ($) | Aug. 11, 2003 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
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 | |||
Royalty Agreements [Member] | ||||
Commitments and Contingencies Disclosure [Line Items] | ||||
Future royalty payment percentage on gross revenue | 3.00% | |||
Royalty cost | $ 675,000 | $ 600,000 | $ 393,000 | |
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 | $ 1,125,000 | $ 1,002,000 | $ 655,000 |
STOCKHOLDERS' EQUITY - Stock op
STOCKHOLDERS' EQUITY - Stock option activity (Details) - $ / shares | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Shares | ||||
Outstanding | 3,658,462 | 3,578,538 | 2,762,177 | |
Granted | 1,557,300 | 1,481,675 | 1,204,950 | |
Forfeited | (747,671) | (544,671) | (165,720) | |
Expired | (16,320) | (800) | (34,020) | |
Exercised | (233,582) | (856,280) | (188,849) | |
Outstanding | 4,218,189 | 3,658,462 | 3,578,538 | 2,762,177 |
Weighted Average Exercise Price per Share | ||||
Outstanding | $ 5.82 | $ 4.64 | $ 4.69 | |
Granted | 7.19 | 8.01 | 5.46 | |
Forfeited | 7.39 | 7.49 | 5.50 | |
Expired | 4.16 | 2.88 | 34.61 | |
Exercised | 4.09 | 3.65 | 4.40 | |
Outstanding | $ 6.16 | $ 5.82 | $ 4.64 | $ 4.69 |
Weighted Average Remaining Contractual Life (Years) | ||||
Outstanding | 7 years | 7 years | 6 years 3 months 18 days | 6 years |
Granted | 9 years 6 months | 9 years 2 months 12 days | 0 years | |
Forfeited | 0 years | 0 years | 0 years | |
Expired | 0 years | 0 years | 0 years | |
Exercised | 0 years | 0 years | 0 years |
STOCKHOLDERS' EQUITY - Intrinsi
STOCKHOLDERS' EQUITY - Intrinsic value (Details) | 12 Months Ended |
Dec. 31, 2019USD ($)$ / sharesshares | |
Options Exercisable | |
Number Outstanding at December 31,2019 | shares | 3,034,399 |
Weighted Average Exercise Price | $ 5.74 |
Aggregate Intrinsic Value | $ | $ 212,313 |
$2.23 - $14.80 | |
Options Outstanding | |
Range of Exercise Price, Lower Range Limit | $ 2.23 |
Range of Exercise Price, Upper Range Limit | $ 14.80 |
Number Outstanding at December 31,2019 | shares | 4,218,189 |
Weighted Average Exercise Price | $ 6.16 |
Weighted Average Remaining Life (Years) | 7 years |
Aggregate Intrinsic Value | $ | $ 212,353 |
STOCKHOLDERS' EQUITY - Non-vest
STOCKHOLDERS' EQUITY - Non-vested options (Details) - $ / shares | 1 Months Ended | 12 Months Ended | ||
Apr. 23, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Shares | ||||
Non-vested, January 1, 2019 | 1,251,617 | |||
Granted | 1,557,300 | 1,481,675 | 1,204,950 | |
Forfeited | (716,855) | |||
Vested | (1,200,450) | (908,272) | ||
Non-vested, December 31, 2019 | 1,183,790 | 1,251,617 | ||
Weighted Average Grant Date Fair Value | ||||
Non-vested, January 1, 2019 | $ 4.56 | |||
Granted | 4.51 | |||
Forfeited | 4.67 | |||
Vested | 4.47 | |||
Non-vested, December 31, 2019 | $ 4.49 | $ 4.56 |
STOCKHOLDERS' EQUITY - Restrict
STOCKHOLDERS' EQUITY - Restricted stock unit (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Restricted Stock Units, Intrinsic Value Beginning Balance | $ 16,192,320 | |
Restricted Stock Units, Intrinsic Value Ending Balance | $ 8,033,988 | $ 16,192,320 |
Restricted stock | ||
Restricted Stock Units, Beginning Balance | 2,004,000 | 1,755,000 |
Restricted Stock Units, Granted | 264,500 | 318,750 |
Restricted Stock Units, Forfeited | (181,750) | (69,750) |
Restricted Stock Units, Ending Balance | 2,086,750 | 2,004,000 |
Restricted stock | Board of Directors | ||
Restricted Stock Units, Beginning Balance | 277,200 | 264,000 |
Restricted Stock Units, Granted | 0 | 13,200 |
Restricted Stock Units, Forfeited | 0 | 0 |
Restricted Stock Units, Ending Balance | 277,200 | 277,200 |
Restricted stock | Executive Management | ||
Restricted Stock Units, Beginning Balance | 724,500 | 675,300 |
Restricted Stock Units, Granted | 0 | 49,200 |
Restricted Stock Units, Forfeited | (120,000) | 0 |
Restricted Stock Units, Ending Balance | 604,500 | 724,500 |
Restricted stock | Other Employees | ||
Restricted Stock Units, Beginning Balance | 1,002,300 | 815,700 |
Restricted Stock Units, Granted | 264,500 | 256,350 |
Restricted Stock Units, Forfeited | (61,750) | (69,750) |
Restricted Stock Units, Ending Balance | 1,205,050 | 1,002,300 |
STOCKHOLDERS' EQUITY - Restri_2
STOCKHOLDERS' EQUITY - Restricted stock unit activity (Details) - Restricted stock | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Shares | |
Non-vested, January 1, 2019 | shares | 139,138 |
Granted | shares | 202,520 |
Forfeited | shares | (15,882) |
Vested | shares | (157,904) |
Non-vested, December 31, 2019 | shares | 167,872 |
Weighted Average Grant Date Fair Value | |
Non-vested, January 1, 2019 | $ / shares | $ 7.18 |
Granted | $ / shares | 7.41 |
Forfeited | $ / shares | 7.62 |
Vested | $ / shares | 7.07 |
Non-vested, December 31, 2019 | $ / shares | $ 7.52 |
STOCKHOLDERS' EQUITY - Addition
STOCKHOLDERS' EQUITY - Additional information (Details) | Feb. 18, 2020 | Jul. 22, 2019USD ($)shares | May 31, 2019USD ($)$ / sharesshares | Mar. 04, 2019USD ($)shares | Mar. 15, 2018shares | Jun. 30, 2019shares | Apr. 23, 2018shares | Feb. 28, 2018USD ($)shares | Feb. 24, 2018USD ($)shares | Feb. 24, 2017USD ($)shares | Mar. 02, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)item$ / sharesshares | Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($)shares | Jul. 09, 2019shares | Jul. 26, 2018USD ($) | Feb. 15, 2018shares | Dec. 31, 2016shares |
Stockholders Equity [Line Items] | ||||||||||||||||||
Number of common stock authorized | 50,000,000 | 100,000,000 | 100,000,000 | |||||||||||||||
Number of common stock issued | 32,616,107 | 31,774,139 | ||||||||||||||||
Number of shares issued | 100,000,000 | 2,626,330 | ||||||||||||||||
Aggregate registered amount for offerings | $ | $ 150,000,000 | |||||||||||||||||
Average selling price | $ / shares | $ 5.53 | |||||||||||||||||
Net proceeds from issuance of stock | $ | $ 14,126,525 | |||||||||||||||||
Number of Long Term Incentive Plans | item | 2 | |||||||||||||||||
Outstanding | 4,218,189 | 3,658,462 | 3,578,538 | 2,762,177 | ||||||||||||||
Allocated Share-based Compensation Expense | $ | $ 1,666,000 | $ 4,437,000 | $ 3,314,000 | |||||||||||||||
Exercise price per share | $ / shares | $ 3.85 | |||||||||||||||||
Risk free interest rate, minimum | 1.40% | |||||||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ | $ 3,098,000 | |||||||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 4 years | |||||||||||||||||
Number of option granted | 1,557,300 | 1,481,675 | 1,204,950 | |||||||||||||||
Share based Compensation Option Milestones met By the Company Percentage | 35.00% | |||||||||||||||||
Stock or Unit Option Plan Expense | $ | $ 315,000 | $ 3,381,000 | ||||||||||||||||
Number of options granted | 531,900 | 668,550 | 953,200 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Number of Shares | 1,200,450 | 908,272 | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Aggregate Intrinsic Value, Nonvested | $ | $ 5,636,000 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, NonVested in Period, Fair Value | $ | $ 3,284,000 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number | 726,920 | 810,220 | ||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | $ | $ 663,368 | 545,693 | $ 207,608 | |||||||||||||||
Class of Warrant or Right, Outstanding | 30,000 | |||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 9.90 | |||||||||||||||||
Maximum | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Stock or Unit Option Plan Expense | $ | 2,791,000 | |||||||||||||||||
Accumulated Other Comprehensive (Loss) [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | $ | $ 0 | 0 | 0 | |||||||||||||||
Warrant [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Warrants exercised | 369,387 | |||||||||||||||||
Option | Employees | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Number of option granted | 926,800 | |||||||||||||||||
Grant date fair value of these unvested options | $ | $ 4,294,000 | |||||||||||||||||
Stock Option Plan One [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Common stock reserved for issuance | 2,400,000 | |||||||||||||||||
Outstanding | 743,000 | |||||||||||||||||
Two Thousand Fourteen Stock Option Plan [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Common stock reserved for issuance | 13,400,000 | |||||||||||||||||
Outstanding | 6,100,000 | |||||||||||||||||
February 24, 2017 Performance-Based Award [Member] | Restricted stock | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 125,000 | |||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ | $ 700,000 | |||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | $ | $ 150,000 | 329,000 | 201,000 | |||||||||||||||
February 24, 2017 Performance-Based Award [Member] | Restricted stock | On the date of the grant | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||||
February 24, 2017 Performance-Based Award [Member] | Restricted stock | First anniversary of the date of the grant | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||||
February 24, 2017 Performance-Based Award [Member] | Restricted stock | Second anniversary of the date of the grant | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||||
February 28, 2018 Performance-Based Award [Member] | Restricted stock | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 146,200 | |||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ | $ 1,148,000 | |||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | $ | 363,000 | $ 319,000 | $ 383,000 | |||||||||||||||
February 28, 2018 Performance-Based Award [Member] | Restricted stock | On the date of the grant | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||||
February 28, 2018 Performance-Based Award [Member] | Restricted stock | First anniversary of the date of the grant | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||||
February 28, 2018 Performance-Based Award [Member] | Restricted stock | Second anniversary of the date of the grant | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||||
March 4, 2019 Performance-Based Award [Member] | Restricted stock | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 22,220 | |||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ | $ 179,000 | |||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | $ | $ 39,000 | |||||||||||||||||
March 4, 2019 Performance-Based Award [Member] | Restricted stock | On the date of the grant | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||||
March 4, 2019 Performance-Based Award [Member] | Restricted stock | First anniversary of the date of the grant | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||||
March 4, 2019 Performance-Based Award [Member] | Restricted stock | Second anniversary of the date of the grant | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||||
July 22, 2019 Performance-Based Award [Member] | Restricted stock | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 180,300 | |||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ | $ 1,300,000 | |||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | $ | $ 621,000 | |||||||||||||||||
July 22, 2019 Performance-Based Award [Member] | Restricted stock | On the date of the grant | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||||
July 22, 2019 Performance-Based Award [Member] | Restricted stock | First anniversary of the date of the grant | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||||
July 22, 2019 Performance-Based Award [Member] | Restricted stock | Second anniversary of the date of the grant | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Vesting percentage | 33.30% | |||||||||||||||||
Cantor Fitzgerald and Co. [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Number of shares issued | 2,094,140 | |||||||||||||||||
Average selling price | $ / shares | $ 8.72 | |||||||||||||||||
Net proceeds from issuance of stock | $ | $ 17,718,000 | |||||||||||||||||
Jefferies LLC and B. Riley FBR, Inc [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Number of common stock authorized | 25,000,000 | |||||||||||||||||
Number of shares issued | 191,244 | |||||||||||||||||
Average selling price | $ / shares | $ 4.11 | |||||||||||||||||
Net proceeds from issuance of stock | $ | $ 762,000 | |||||||||||||||||
Commission rate (as a percent) | 3.00% | |||||||||||||||||
Series A Preferred Stock [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Preferred Stock, Shares Authorized | 5,000,000 | |||||||||||||||||
Exercise Price Ranging From 3.84 To 8.25 | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 10 years | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | |||||||||||||||||
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 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 74.30% | |||||||||||||||||
Exercise Price Ranging From 3.84 To 8.25 | Minimum | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Exercise price per share | $ / shares | $ 3.84 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 61.90% | |||||||||||||||||
Subsequent event | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Number of shares issued | 2,435,086 | |||||||||||||||||
Average selling price | $ / shares | $ 5.64 | |||||||||||||||||
Net proceeds from issuance of stock | $ | $ 13,322,000 |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
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 | 6,503,000 | 6,232,000 | 6,326,000 |
RETIREMENT PLAN (Details)
RETIREMENT PLAN (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2014 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
RETIREMENT PLAN | ||||
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 | $ 43,800 | $ 43,600 | $ 41,700 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) | 2 Months Ended | 12 Months Ended |
Mar. 02, 2020 | Dec. 31, 2019 | |
Subsequent Event [Line Items] | ||
Share Price | $ 5.53 | |
Net proceeds from issuance of stock | $ 14,126,525 | |
Subsequent event | ||
Subsequent Event [Line Items] | ||
Operating Leases, Rent Expense | $ 2,435,086 | |
Share Price | $ 5.64 | |
Net proceeds from issuance of stock | $ 13,322,000 |
QUARTERLY FINANCIAL RESULTS (_3
QUARTERLY FINANCIAL RESULTS (UNAUDITED) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
QUARTERLY FINANCIAL RESULTS (UNAUDITED) | |||||||||||||||
Total revenue | $ 7,430,311 | $ 6,095,007 | $ 6,232,526 | $ 5,191,629 | $ 6,080,844 | $ 5,742,975 | $ 5,755,438 | $ 4,924,651 | $ 4,646,711 | $ 3,824,299 | $ 3,566,226 | $ 3,113,518 | $ 24,949,473 | $ 22,503,908 | $ 15,150,754 |
Gross margin | 5,335,621 | 4,398,733 | 4,398,160 | 3,453,040 | 3,997,640 | 3,690,278 | 3,969,584 | 3,357,006 | 3,381,708 | 2,307,435 | 2,084,216 | 1,859,035 | 17,585,554 | 15,014,508 | 9,632,394 |
Loss from operations | (5,431,328) | (5,627,546) | (3,629,997) | (4,285,193) | (5,585,266) | (2,710,620) | (4,187,875) | (3,101,167) | (3,805,167) | (2,149,045) | (2,330,908) | (1,557,478) | (18,974,064) | (15,584,928) | (9,842,598) |
Net loss attributable to common stockholders | $ (3,949,351) | $ (6,885,061) | $ (3,547,405) | $ (4,883,827) | $ (5,403,178) | $ (3,004,764) | $ (5,821,202) | $ (2,982,035) | $ (3,147,019) | $ (2,054,279) | $ (2,070,359) | $ (1,524,873) | $ (19,265,644) | $ (17,211,179) | $ (8,796,530) |
Net loss per share, basic and diluted | $ (0.13) | $ (0.21) | $ (0.11) | $ (0.15) | $ (0.17) | $ (0.10) | $ (0.19) | $ (0.10) | $ (0.12) | $ (0.07) | $ (0.07) | $ (0.06) | $ (0.60) | $ (0.56) | $ (0.32) |