Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Oct. 31, 2018 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | Cytosorbents Corp | |
Entity Central Index Key | 1,175,151 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Trading Symbol | CTSO | |
Entity Common Stock, Shares Outstanding | 31,651,821 | |
Entity Emerging Growth Company | false | |
Entity Small Business | true |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Current Assets: | ||
Cash and cash equivalents | $ 24,911,264 | $ 17,321,862 |
Grants and accounts receivable, net of allowance for doubtful accounts of $80,873 at September 30, 2018 and $72,698 at December 31, 2017 | 3,642,510 | 2,205,859 |
Inventories | 779,425 | 795,657 |
Prepaid expenses and other current assets | 617,119 | 415,962 |
Total current assets | 29,950,318 | 20,739,340 |
Property and equipment, net | 1,677,049 | 1,402,782 |
Other assets | 2,622,104 | 1,961,185 |
Total Assets | 34,249,471 | 24,103,307 |
Current Liabilities: | ||
Accounts payable | 1,859,328 | 1,244,411 |
Current maturities of long-term debt | 0 | 4,000,000 |
Accrued expenses and other current liabilities | 2,401,975 | 2,603,920 |
Total current liabilities | 4,261,303 | 7,848,331 |
Long term debt, net of current maturities and debt issuance costs | 9,917,439 | 5,992,141 |
Total Liabilities | 14,178,742 | 13,840,472 |
Commitments and Contingencies (Note 6) | ||
Stockholders' Equity: | ||
Preferred Stock, 5,000,000 shares authorized; -0- shares issued and outstanding at September 30, 2018 and December 31, 2017 | 0 | 0 |
Common Stock, Par Value $0.001, 50,000,000 shares authorized; 31,633,432 and 28,973,679 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively | 31,633 | 28,974 |
Additional paid-in capital | 184,089,635 | 162,907,482 |
Accumulated other comprehensive income (loss) | 70,097 | (360,985) |
Accumulated deficit | (164,120,636) | (152,312,636) |
Total stockholders' equity | 20,070,729 | 10,262,835 |
Total Liabilities and Stockholders' Equity | $ 34,249,471 | $ 24,103,307 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Allowance for doubtful accounts | $ 80,873 | $ 72,698 |
Preferred Stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred Stock, shares issued | 0 | 0 |
Preferred Stock, shares outstanding | 0 | 0 |
Common Stock, Par Value | $ 0.001 | $ 0.001 |
Common Stock, shares authorized | 50,000,000 | 50,000,000 |
Common Stock, shares issued | 31,633,432 | 28,973,679 |
Common Stock, shares outstanding | 31,633,432 | 28,973,679 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenue: | ||||
CytoSorb sales | $ 5,102,748 | $ 3,416,461 | $ 14,693,699 | $ 9,029,606 |
Other sales | 0 | 32,200 | 87,900 | 56,200 |
Total product sales | 5,102,748 | 3,448,661 | 14,781,599 | 9,085,806 |
Grant income | 640,225 | 375,638 | 1,641,464 | 1,418,237 |
Total revenue | 5,742,973 | 3,824,299 | 16,423,063 | 10,504,043 |
Cost of revenue | 2,052,696 | 1,516,864 | 5,406,195 | 4,253,357 |
Gross profit | 3,690,277 | 2,307,435 | 11,016,868 | 6,250,686 |
Other expenses: | ||||
Research and development | 1,943,417 | 643,193 | 5,299,475 | 1,555,491 |
Legal, financial and other consulting | 416,634 | 238,303 | 1,290,783 | 961,444 |
Selling, general and administrative | 4,040,847 | 3,574,984 | 14,426,272 | 9,771,182 |
Total expenses | 6,400,898 | 4,456,480 | 21,016,530 | 12,288,117 |
Loss from operations | (2,710,621) | (2,149,045) | (9,999,662) | (6,037,431) |
Other income/(expense): | ||||
Interest expense, net | (185,238) | (253,780) | (1,264,161) | (497,683) |
Gain (loss) on foreign currency transactions | (108,903) | 348,546 | (544,177) | 1,221,334 |
Total other income (expense), net | (294,141) | 94,766 | (1,808,338) | 723,651 |
Loss before benefit from income taxes | (3,004,762) | (2,054,279) | (11,808,000) | (5,313,780) |
Benefit from income taxes | 0 | 0 | 0 | 0 |
Net loss | (3,004,762) | (2,054,279) | (11,808,000) | (5,313,780) |
Dividend, warrant exercise price adjustment | 0 | 0 | 0 | (335,731) |
Net loss available to common stockholders | $ (3,004,762) | $ (2,054,279) | $ (11,808,000) | $ (5,649,511) |
Basic and diluted net loss per common share | $ (0.10) | $ (0.07) | $ (0.39) | $ (0.21) |
Weighted average number of shares of common stock outstanding | 31,305,620 | 28,206,437 | 30,394,326 | 27,231,145 |
Net loss | $ (3,004,762) | $ (2,054,279) | $ (11,808,000) | $ (5,313,780) |
Other comprehensive income (loss): | ||||
Currency translation adjustment | 99,286 | (280,078) | 431,082 | (1,021,961) |
Comprehensive loss | $ (2,905,476) | $ (2,334,357) | $ (11,376,918) | $ (6,335,741) |
CONSOLIDATED STATEMENT OF CHANG
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY - 9 months ended Sep. 30, 2018 - USD ($) | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2017 | $ 10,262,835 | $ 28,974 | $ 162,907,482 | $ (360,985) | $ (152,312,636) |
Beginning Balance (in shares) at Dec. 31, 2017 | 28,973,679 | ||||
Stock based compensation - employees, consultants and directors | 2,863,739 | $ 0 | 2,863,739 | 0 | 0 |
Issuance of common stock, net of fees | 13,916,963 | $ 1,498 | 13,915,465 | 0 | 0 |
Issuance of common stock, net of fees (in shares) | 1,498,230 | ||||
Other comprehensive income: foreign translation adjustment | 431,082 | $ 0 | 0 | 431,082 | |
Proceeds from exercise of stock options | 1,940,711 | $ 578 | 1,940,133 | 0 | 0 |
Proceeds from exercise of stock options (in shares) | 576,936 | ||||
Cashless exercise of stock options | 0 | $ 49 | (49) | 0 | 0 |
Cashless exercise of stock options (in shares) | 50,032 | ||||
Cashless exercise of warrants | 0 | $ 89 | (89) | 0 | 0 |
Cashless exercise of warrants (in shares) | 89,556 | ||||
Issuance of restricted stock units | 545,693 | $ 62 | 545,631 | 0 | 0 |
Issuance of restricted stock units (in shares) | 62,406 | ||||
Proceeds from exercise of warrants | 1,280,706 | $ 314 | 1,280,392 | 0 | 0 |
Proceeds from exercise of warrants (in shares) | 313,802 | ||||
Success fee – Bridge Bank | 637,000 | $ 69 | 636,931 | 0 | 0 |
Success fee – Bridge Bank (in shares) | 68,791 | ||||
Net loss | (11,808,000) | $ 0 | 0 | 0 | (11,808,000) |
Ending Balance at Sep. 30, 2018 | $ 20,070,729 | $ 31,633 | $ 184,089,635 | $ 70,097 | $ (164,120,636) |
Ending Balance (in shares) at Sep. 30, 2018 | 31,633,432 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (11,808,000) | $ (5,313,780) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-cash interest expense | 637,000 | 0 |
Non-cash compensation | 734,308 | 251,729 |
Depreciation and amortization | 256,794 | 161,688 |
Amortization of debt costs | 73,286 | 56,268 |
Bad debt | 16,722 | 3,897 |
Stock-based compensation | 2,863,739 | 1,851,020 |
Foreign currency transaction loss (gain) | 544,177 | (1,221,334) |
Changes in operating assets and liabilities: | ||
Grants and accounts receivable | (1,518,237) | (803,348) |
Inventories | 14,259 | (227,882) |
Prepaid expenses and other current assets | (209,683) | (8,528) |
Other assets | (6,414) | (15,000) |
Accounts payable and accrued expenses | 269,511 | (785,951) |
Net cash used by operating activities | (8,132,538) | (6,051,221) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (495,526) | (579,944) |
Payments for patent costs | (701,306) | (516,203) |
Net cash used by investing activities | (1,196,832) | (1,096,147) |
Cash flows from financing activities: | ||
Proceeds from long-term debt | 666,667 | 5,000,000 |
Repayment of long-term debt | (666,667) | 0 |
Payment of debt acquisition costs | (147,988) | (1,560) |
Equity contributions - net of fees incurred | 13,916,963 | 11,775,046 |
Proceeds from exercise of stock options | 1,940,711 | 181,480 |
Proceeds from exercise of warrants | 1,280,706 | 260,504 |
Net cash provided by financing activities | 16,990,392 | 17,215,470 |
Effect of exchange rates on cash | (71,620) | 87,068 |
Net change in cash and cash equivalents | 7,589,402 | 10,155,170 |
Cash and cash equivalents - beginning of period | 17,321,862 | 5,245,178 |
Cash and cash equivalents - end of period | 24,911,264 | 15,400,348 |
Supplemental disclosure of cash flow information: | ||
Cash paid during the period for interest | 667,427 | 407,347 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Settlement of accrued bonuses with restricted stock units | 545,693 | 207,608 |
Dividend, warrant exercise price adjustment | 0 | 335,731 |
Proceeds from sale of stock not yet received | 0 | 196,417 |
Settlement of Success Fee with common stock | $ 637,000 | $ 0 |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
BASIS OF PRESENTATION | 1. BASIS OF PRESENTATION The interim financial statements of CytoSorbents Corporation (the “Company”) have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments, for a fair statement of the Company’s financial position and results of operations for the interim periods presented. Certain information and disclosures normally included in the annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These interim financial statements should be read in conjunction with the audited financial statements and accompanying notes for the year ended December 31, 2017 included in the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (the “SEC”) on March 8, 2018. The results for the three and nine months ended September 30, 2018 and 2017 are not necessarily indicative of the results to be expected for a full year, any other interim periods or any future year or period. 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. As of September 30, 2018, the Company had an accumulated deficit of $164,120,636, which included net losses of $11,808,000 for the nine months ended September 30, 2018 and $5,313,780 for the nine months ended September 30, 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 net 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 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 | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 2. PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Nature of Business The Company is a leader in critical care immunotherapy using blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world. The Company, through its subsidiary CytoSorbents Medical, Inc. (formerly known as CytoSorbents, Inc.), is engaged in the research, development and commercialization of medical devices with its blood purification technology platform which incorporates a proprietary adsorbent, porous polymer technology. The Company, through its wholly owned European subsidiary, CytoSorbents Europe GmbH, conducts sales and marketing related operations for the CytoSorb device. In March 2016, the Company formed CytoSorbents Switzerland GmbH, a wholly-owned subsidiary of CytoSorbents Europe GmbH. This subsidiary, which began operations during the second quarter of 2016, provides marketing and direct sales services in Switzerland. CytoSorb, the Company’s flagship product, was approved in the in March 2011,and is currently being marketed in and distributed in fifty-three countries around the world, as a safe and effective extracorporeal cytokine absorber, designed to reduce the “cytokine storm” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. In May 2018, the Company received a label extension for CytoSorb covering use of the device for the removal of bilirubin and myoglobin which allows for the use of the device in the treatment of liver failure and trauma, respectively. CytoSorb is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. The technology is based upon biocompatible, highly porous polymer sorbent beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface absorption. The Company has numerous products under development based upon this unique blood purification technology, which is protected by 19 issued U.S. patents and multiple international patents, with applications pending both in the U.S. and internationally, including HemoDefend, ContrastSorb, DrugSorb, and others. These patents and patent applications are directed to various compositions and methods of use related to our blood purification technologies and are expected to expire between 2020 and 2035, absent any patent term extensions. Management believes that any near term expiring patents will not have a significant impact on our ongoing business. Stock Market Listing On December 17, 2014 the Company’s common stock, par value $0.001 per share, was approved for listing on the Nasdaq Capital Market (“Nasdaq”), and it began trading on Nasdaq on December 23, 2014 under the symbol “CTSO.” Previously, the Company’s common stock traded in the over-the-counter-market on the OTC Bulletin Board. Basis of Consolidation and Foreign Currency Translation The consolidated financial statements include the accounts of the parent, CytoSorbents Corporation, and its direct and indirect wholly-owned subsidiaries, CytoSorbents Medical, Inc, CytoSorbents Europe GmbH and CytoSorbents Switzerland GmbH. All significant intercompany transactions and balances have been eliminated in consolidation. Translation gains and losses resulting from the process of remeasuring into the U.S. dollar, the foreign currency financial statements of CytoSorbents Europe GmbH, for which the local currency is the functional currency, are included in other comprehensive income. Foreign currency transaction gains (loss) included in net loss amounted to approximately $(109,000) and $349,000 for the three months ended September 30, 2018 and 2017, respectively. Foreign currency transaction gains (loss) included in net loss amounted to approximately $(544,000) and $1,221,000 for the nine months ended September 30, 2018 and 2017, respectively. The Company translates assets and liabilities of CytoSorbents Europe GmbH, 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 stockholders’ equity as a component of accumulated other comprehensive income. Cash and Cash Equivalents The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Grants and Accounts Receivable Grants receivable represent amounts due from U.S. government agencies and are included in Grants and Accounts Receivable. Accounts receivable are unsecured, non-interest bearing customer obligations due under normal trade terms. The Company sells its devices to various hospitals and distributors. The Company performs ongoing credit evaluations of its customers’ financial conditions. Management reviews accounts receivable periodically to determine collectability. Balances that are determined to be uncollectible are written off to the allowance for doubtful accounts. The allowance for doubtful accounts contains a general accrual for estimated bad debts and amounted to approximately $81,000 and $73,000 at September 30, 2018 and December 31, 2017, respectively. Inventories Inventories are valued at the lower of cost or net realizable value under the first in, first out (FIFO) method. At September 30, 2018 and December 31, 2017, the Company’s inventory was comprised of finished goods, which amounted to $159,998 and $151,872, respectively; work in process which amounted to $390,497 and $528,039, respectively; and raw materials, which amounted to $228,930 and $115,746, 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 and successfully defend patents are capitalized. When patents are issued, capitalized costs are amortized on the straight-line method over the related patent term. In the event a patent is abandoned, the net book value of the patent is written off. Impairment or Disposal of Long-Lived Assets The Company assesses the impairment of patents and other long-lived assets under accounting standards for the impairment or disposal of long-lived assets whenever events or changes in circumstances indicate that the carrying value may not be recoverable. For long-lived assets to be held and used, the Company recognizes an impairment loss only if its carrying amount is not recoverable through its undiscounted cash flows and measures the impairment loss based on the difference between the carrying amount and fair value. Revenue Recognition Product Sales : Revenues from sales of products to both direct and distributor/strategic partner customers are recognized at the time when control passes to the customer, in accordance with the terms of their respective contracts. Recognition of revenue occurs as each performance obligation is completed. Grant Income : Revenue from grant income is based on contractual agreements. Certain agreements provide for reimbursement of costs, while other agreements provide for reimbursement of costs and an overhead margin. Revenues are recognized when the associated performance obligation is fulfilled. Costs are recorded as incurred. Costs subject to reimbursement by these grants have been reflected as costs of revenue. Research and Development All research and development costs, payments to laboratories and research consultants are expensed when incurred. Advertising Expenses Advertising expenses are charged to activities when incurred. Advertising expenses amounted to approximately $40,000 and $45,000 for the three months ended September 30, 2018 and 2017, respectively, and approximately $126,000 and $132,000 for the nine months ended September 30, 2018 and 2017, respectively, and are included in selling, general, and administrative expenses on the consolidated statement 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. The Company has provided a valuation allowance against all deferred tax assets. Under Section 382 of the Internal Revenue Code, the net operating losses generated prior to the previously completed reverse merger may be limited due to the change in ownership. Additionally, net operating losses generated subsequent to the reverse merger may be limited in the event of changes in ownership. The Tax Cuts and Job Act was enacted on December 22, 2017 and reduces the U.S. Federal corporate income tax rate from 35% to 21%. The Company follows accounting standards associated with uncertain tax positions. The Company had no unrecognized tax benefits at September 30, 2018 or December 31, 2017. The Company files tax returns in the U.S. federal and state jurisdictions. The Company utilizes the Technology Business Tax Certificate Transfer Program to sell a portion of its New Jersey Net Operating Loss carry forwards to an industrial company. Each of CytoSorbents Europe GmbH and CytoSorbents Switzerland GmbH files an annual corporate tax return, VAT return and a trade tax return in Germany and Switzerland, respectively. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities. Actual results could differ from these estimates. 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 4 for further information relating to the Company’s revenue.) As of September 30, 2018, one distributor accounted for approximately 14% of outstanding grants and accounts receivable. As of September 30, 2017, two distributors accounted for approximately 33% of outstanding grants and accounts receivable. As of December 31, 2017, two distributors accounted for approximately 28% of outstanding grants and accounts receivable. For the three and nine months ended September 30, 2018 and 2017, no agency, distributor, or direct customer represented more than 10% of the Company’s total revenue. Financial Instruments The carrying values of cash and cash equivalents, short-term investments, accounts payable, notes payable, and other debt obligations approximate their fair values due to their short-term nature. Net Loss Per Common Share Basic earnings per share is computed by dividing loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per common share is computed using the treasury stock method on the basis of the weighted-average number of shares of common stock plus the dilutive effect of potential common shares outstanding during the period. Dilutive potential common shares include outstanding warrants, stock options and restricted shares. The computation of diluted earnings per share does not assume conversion, exercise or contingent exercise of securities that would have an anti-dilutive effect on earnings (See Note 7). Stock-Based Compensation The Company accounts for its stock-based compensation under the recognition requirements of accounting standards for accounting for stock-based compensation, for employees and directors whereby each option granted is valued at fair market value on the date of grant. Under these accounting standards, the fair value of each option is estimated on the date of grant using the Black-Scholes option pricing model. The Company also follows the guidance of accounting standards for accounting for equity instruments that are issued to other than employees for acquiring, or in conjunction with selling, goods or services for equity instruments issued to consultants. 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 has evaluated the impact of the updated guidance and has determined that the adoption of ASU 2016-02 is not expected to have a significant impact on its consolidated financial statements. Shipping and Handling Costs The cost of shipping product to customers and distributors is typically borne by the customer or distributor. The Company records other shipping and handling costs in cost of revenue. Total freight costs amounted to approximately $67,000 and $50,000, respectively, for the three months ended September 30, 2018 and 2017, and $273,000 and $178,000, respectively, for the nine months ended September 30, 2018 and 2017. Reclassifications Certain reclassifications have been made to the September 30, 2017 financial statements in order to conform to the 2018 financial statement presentation. There was no change in the reported amount of the accumulated deficit as a result of these reclassifications. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2018 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS' EQUITY | 3. STOCKHOLDERS' EQUITY Preferred Stock In December 2014, the Company amended and restated its certificate of incorporation to reduce the total number of authorized shares of preferred stock. The amended and restated certificate of incorporation authorizes the issuance of up to 5,000,000 shares of “blank check” preferred stock, par value $0.001 per share, with such designation rights and preferences as may be determined from time to time by the Board of Directors. Common Stock Shelf Registration On July 29, 2015, the Company’s registration statement on Form S-3, as filed with the SEC on July 23, 2015 (the “2015 Shelf”), was declared effective using a “shelf” registration process. On July 26, 2018, in anticipation of the expiration of the 2015 Shelf, the Company filed a new 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. April 5, 2017 Equity Offering On April 5, 2017, the Company closed on the sale of an aggregate of 2,222,222 shares of common stock pursuant to the Company's 2015 Shelf. The Company received gross proceeds of approximately $10,000,000, from the sale of such shares based on a public offering price of $4.50 per share. On April 11, 2017, the Company closed the sale of an additional 333,333 shares of the Company’s common stock, pursuant to the underwriters’ full exercise of an over-allotment option. The Company received gross proceeds of approximately $1,500,000 from the exercise of the option. As a result, the Company received total gross proceeds of $11,500,000 from the offering, and, after deducting the underwriting discounts and commissions and related expenses, the Company received total net proceeds of approximately $10,300,000. As a result of this offering, the exercise price of the warrants issued in connection with the Company’s March 11, 2014 public offering was reduced to $4.50 in accordance with the pricing provisions of those warrants. There was no change in the number of warrants which were repriced. As a result of the repricing of the warrants which occurred in connection with the April 2017 equity offering, the Company recorded a dividend of $335,731 during the year ended December 31, 2017. November 4, 2015 Controlled Equity Offering On November 4, 2015, the Company entered into a Controlled Equity Offering SM On July 26, 2018, the Company entered into that certain Amendment No. 1 to the Sales Agreement (the “Sales Agreement Amendment”) to extend the term of the Sales Agreement until the expiration of the 2018 Shelf. The other provisions of the Sales Agreement remain unchanged. References herein to “Sales Agreement” shall refer to the Sales Agreement, as amended by the Sales Agreement Amendment. Under the Sales Agreement, Cantor may sell Shares by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act, including sales made directly on Nasdaq, on any existing trading market for the common stock or to or through a market maker. In addition, under the Sales Agreement, Cantor may sell the Shares by any other method permitted by law, including in privately negotiated transactions. The Company may instruct Cantor not to sell Shares if the sales cannot be effected at or above the price designated by the Company from time to time. The Company is not obligated to make any sales of Shares under the Sales Agreement, and if it elects to make any sales, the Company can set a minimum sales price for the Shares. The offering of Shares pursuant to the Sales Agreement will terminate upon the earlier of (a) the expiration of the 2018 Shelf (b) the termination of the Sales Agreement by Cantor or the Company, as permitted therein. From November 4, 2015 through December 31, 2015, the Company sold 28,880 shares, generating net proceeds of approximately $225,000 under the Sales Agreement. There were no sales during the year ended December 31, 2016. During the year ended December 31, 2017, the Company sold 550,000 shares at an average price of $6.31 per share, generating net proceeds of approximately $3,367,000. During the nine months ended September 30, 2018, the Company sold 1,498,320 shares at an average cost of $9.58 per share, generating net proceeds of approximately $13,917,000. From October 1, 2018 through October 31, 2018, the Company sold 17,030 shares at an average cost of $12.69 per share, generating net proceeds of approximately $209,000. In the aggregate, the Company has sold 2,094,230 shares at an average selling price of $8.72 per share, generating net proceeds of approximately $17,718,000 under the terms of the Sales Agreement. The Company pays a commission rate of 3.0% of the aggregate gross proceeds from each sale of Shares and has agreed to provide Cantor with customary indemnification and contribution rights. In 2015, the Company reimbursed Cantor $50,000 for certain specified expenses in connection with the execution of the Sales Agreement. The Company intends to use the net proceeds raised through “at the market” sales to fund clinical studies in the United States and abroad, expand production capacity, support its sales and marketing efforts, further develop its products, and for general working capital purposes. Stock-Based Compensation Total share-based employee, director, and consultant compensation for the three and nine months ended September 30, 2018 and 2017 amounted to approximately $274,000 and $960,000, and $2,864,000 and $1,851,000, respectively. These amounts are included in selling, general and administrative expenses on the consolidated statement of operations. The summary of the stock option activity for the nine months ended September 30, 2018 is as follows: Weighted Weighted Average Average Remaining Exercise Price Contractual Shares per Share Life (Years) Outstanding, December 31, 2017 3,578,538 $ 4.64 6.3 Granted 1,428,175 $ 7.98 9.5 Forfeited (55,324 ) $ 5.57 — Expired (800 ) $ 2.88 — Exercised (719,610 ) $ 3.78 — Outstanding, September 30, 2018 4,230,979 $ 5.90 7.3 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 $6.85 to $14.80 per share) and expected life of the stock option (10 years), the current price of the underlying stock and its expected volatility (61.6 to 66.4 percent), expected dividends (-0- percent) on the stock and the risk free interest rate (ranging from 2.09 to 3.00 percent) for the term of the stock option. The intrinsic value is calculated at the difference between the market value as of September 30, 2018 of $12.90 and the exercise price of the shares. Options Outstanding Number Weighted Weighted Range of Outstanding at Average Average Aggregate Exercise September 30, Exercise Remaining Intrinsic Price 2018 Price Life (Years) Value $2.00 - $14.80 4,230,979 $ 5.90 7.3 $ 29,640,061 Options Exercisable Number Weighted Exercisable at Average Aggregate September 30, Exercise Intrinsic 2018 Price Value 2,501,456 $ 4.82 $ 20,253,186 The summary of the status of the Company’s non-vested options for the nine months ended September 30, 2018 is as follows: Weighted Average Grant Date Shares Fair Value Non-vested, December 31, 2017 1,070,959 $ 0.70 Granted 1,428,175 $ 4.83 Forfeited (35,326 ) $ 2.43 Vested (734,285 ) $ 3.41 Non-vested, September 30, 2018 1,729,523 $ 4.52 As of September 30, 2018, the Company had approximately $926,000 of total unrecognized compensation cost related to stock options which will be amortized over twenty-one months. Awards of Stock Options: 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 $5,635,634. Based upon an assessment by management, which was reviewed by the Board of Directors, as of September 30, 2018, the Company has met 37.5% of these milestones, and accordingly we have recorded approximately $-0- and $2,113,000 of stock option expense related to these options in the three and nine months ended September 30, 2018, respectively. The Company will continue to assess the likelihood of meeting these milestones throughout 2018 and will record additional stock option expense as appropriate. 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: Restricted Stock Units Board of Executive Other Directors Management Employees Total Intrinsic Value December 31, 2017 264,000 675,300 729,200 1,668,500 $ 10,845,250 Granted 13,200 49,200 329,350 391,750 Forfeited — — (42,750 ) (42,750 ) September 30, 2018 277,200 724,500 1,015,800 2,017,500 $ 26,025,750 Due to the uncertainty over whether these restricted stock units will vest, which only happens upon a Change in Control, no charge for these restricted stock units has been recorded in the consolidated statement of operations for the three and nine months ended September 30, 2018. Performance-Based Awards of Restricted Stock Units: Pursuant to a review of the compensation of the senior management of the Company, on June 7, 2016, the Board of Directors granted 80,000 restricted stock units to certain senior managers of the Company. These awards were valued at $375,200 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. These awards are charged to expense over the period which they vest. No charge was required to be charged for the three months ended September 30, 2018, as these restricted stock units became fully vested during the quarter ended June 30, 2018. The Company recorded a charge of approximately $14,000 during the three months ending September 30, 2017 on these restricted stock units. During the nine months ended September 30, 2018 and 2017, respectively, the Company recorded a charge of $240,000 and $77,000, 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 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 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 three and nine months ended September 30, 2018 and 2017, the Company recorded a charge of approximately $58,000 for each period. For the nine months ended September 30, 2018 and 2017, the Company recorded a charge of approximately $271,000 and $175,000, 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 three and nine months ended September 30, 2018, the Company recorded a charge of approximately $96,000 and $223,000 related to these restricted stock unit awards. The following table outlines the restricted stock unit activity for the nine months ended September 30, 2018: Weighted Average Grant Date Shares Fair Value Non-vested, January 1, 2018 110,003 $ 5.38 Granted 146,200 $ 7.85 Vested (117,065 ) $ 6.33 Non-vested, September 30, 2018 139,138 $ 7.18 Warrants: As of September 30, 2018, the Company has the following warrants to purchase common stock outstanding: Number of Shares Warrant Exercise Warrant To be Purchased Price per Share Expiration Date 48,960 $ 7.500 March 11, 2019 351,398 $ 4.500 March 11, 2019 30,000 $ 9.900 January 14, 2020 430,358 |
REVENUE
REVENUE | 9 Months Ended |
Sep. 30, 2018 | |
Revenue from Contract with Customer [Abstract] | |
REVENUE | 4. 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 three months ended September 30, 2018: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ – $ – $ – $ – Germany 2,766,922 – – 2,766,922 All other countries 613,491 1,722,335 – 2,335,826 Total product revenue 3,380,413 1,722,335 – 5,102,748 Grant and other income: United States – – 640,225 640,225 Total revenue $ 3,380,413 $ 1,722,335 $ 640,225 $ 5,742,973 The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended September 30, 2017: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 32,200 $ – $ – $ 32,200 Germany 2,093,792 – – 2,093,792 All other countries 485,677 836,992 – 1,322,669 Total product revenue 2,611,669 836,992 – 3,448,661 Grant and other income: United States – – 375,638 375,638 Total revenue $ 2,611,669 $ 836,992 $ 375,638 $ 3,824,299 The following table disaggregates the Company’s revenue by customer type and geographic area for the nine months ended September 30, 2018: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 18,900 $ – $ – $ 18,900 Germany 8,686,596 – – 8,686,596 All other countries 2,034,080 4,042,023 – 6,076,103 Total product revenue 10,739,576 4,042,023 – 14,781,599 Grant and other income: United States – – 1,641,464 1,641,464 Total revenue $ 10,739,576 $ 4,042,023 $ 1,641,464 $ 16,423,063 The following table disaggregates the Company’s revenue by customer type and geographic area for the nine months ended September 30, 2017: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 56,200 $ – $ – $ 56,200 Germany 5,433,209 – – 5,433,209 All other countries 1,175,001 2,421,396 – 3,596,397 Total product revenue 6,664,410 2,421,396 – 9,085,806 Grant and other income: United States – – 1,418,237 1,418,237 Total revenue $ 6,664,410 $ 2,421,396 $ 1,418,237 $ 10,504,043 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 and Luxembourg. 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 as 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. Each distributor’s/strategic partner’s contract has minimum annual purchase requirements in order to maintain exclusivity in their respective territories. Except for Fresenius Medical Care (“FMC”), 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 . The FMC agreement provides that FMC must make specific minimum quarterly purchases. In the event that FMC does not meet the minimum quarterly purchase amounts as stipulated in their agreement, FMC would be required to make minimum quarterly payments. If this situation should occur, which is not anticipated, the Company would record these minimum payments as other income in the financial statements. In addition, certain distributors are eligible for volume discount pricing if their unit sales are in excess of the base amount in the contract. 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. In summary, the contracts the Company has with customers are the distributor/strategic partner contracts related to CytoSorb product sales, agreements with direct customers related to free-of-charge product and credit rebates based upon achieving minimum purchase levels, and contracts with various government agencies related to the Company’s grants. The Company does not currently incur any outside/third party incremental costs to obtain any of these contracts. The Company does incur internal costs, primarily salary related costs, to obtain the contracts related to the grants. Company employees spend time reviewing the program requirements and developing the budget and related proposal to submit to the grantor agency. There may additionally be travel expenditures involved with meeting with government agency officials during the negotiation of the contract. These internal costs are expensed as incurred. The following table provides information about receivables and contract liabilities from contracts with customers: September 30, 2018 December 31, 2017 Receivables, which are included in grants and accounts receivable $ 2,381,031 $ 1,267,459 Contract liabilities $ 35,113 $ 30,380 Contract liabilities represent the value of free of charge goods and credit rebates earned in accordance with the terms of certain direct customer agreements during the periods ended September 30, 2018 and December 31, 2017, and deferred revenue on distributor/strategic partner contracts. Deferred revenue is the difference between the average selling price anticipated for the year ended 2018 and the actual price invoiced during the nine months ended September 30, 2018. There was no deferred revenue liability as of December 31, 2017. |
LONG-TERM DEBT, NET
LONG-TERM DEBT, NET | 9 Months Ended |
Sep. 30, 2018 | |
Debt Disclosure [Abstract] | |
LONG-TERM DEBT, NET | 5. LONG-TERM DEBT, NET On June 30, 2016, the Company and its wholly-owned subsidiary, CytoSorbents Medical, Inc. (together, the “Borrower”), entered into a Loan and Security Agreement with Bridge Bank, a division of Western Alliance Bank, (the “Bank”), pursuant to which the Company borrowed $10 million in two equal tranches of $5 million (the “Original Term Loans”). On March 29, 2018 (the “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”). The proceeds of the Term Loans will be used for general business requirements in accordance with the Amended and Restated Loan and Security Agreement. Outstanding balances on the Term Loans bear interest at the prime rate reported in the Wall Street Journal plus 3.66%. This rate was 8.91% at September 30, 2018. 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. As of the Closing Date, the total unamortized loan costs related to the Term Loans amounted to $130,060. These costs have been presented as a direct deduction from the proceeds of the loan on the consolidated balance sheet in accordance with the provisions of ASC 850. These costs are being amortized over the loan period as a charge to interest expense. For the three and nine months ended September 30, 2018 and 2017, the Company recorded interest expense amounting to $8,129 and $7,558, respectively, and $23,807 and $22,413, 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. Commencing on the first calendar day of the calendar month after a Term Loan is made, the Company shall make monthly payments of interest only during the term of each Term Loan. Commencing on November 1, 2019, if the Term B Loan is not made, the Company shall make equal monthly payments of principal of $333,333, together with accrued and unpaid interest. Commencing on May 1, 2020, subject to certain conditions as outlined in the Amended and Restated Loan and Security Agreement, if the Term B Loan is made, which is at the Company’s sole discretion, the Company shall make equal monthly payments of principal of $625,000, 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 three and nine months ended September 30, 2018 and 2017, the Company recorded interest expense of $15,625 and $18,229, respectively, and $49,479 and $33,854, respectively, related to the final fee. The Term Loans shall be evidenced by one or more secured promissory notes issued to the Bank by the Company. If the Company elects to prepay the Term Loan(s) 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’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). Success Fee Letters: 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 in the accompanying Statement of Operations and Comprehensive Loss. In connection with the Amended and Restated Loan and Security Agreement, the Borrower entered into an additional Success Fee Letter (the “2018 Letter”), which will only be effective if the Term B Loan is drawn. Pursuant to the 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 (the “2018 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 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 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 closing price of the Company’s common stock on the date of the funding of the Term B Loan. If the 2018 Letter Success Fee is due pursuant an event described in clause (d) of the two preceding paragraphs, the Company may elect, in lieu of paying the 2018 Letter Success Fee in cash, to issue and sell to the Bank, in exchange for the 2018 Letter Success Fee, such number of shares of the Company’s common stock as would be equal to the quotient (calculated by rounding up the nearest whole number) obtained by dividing (a) the 2018 Letter Success Fee by (b) the volume weighted average price per share of the Company’s common stock for the same five successive business days on which the closing price per share of the Company’s common stock caused the 2016 Letter Success Fee to become payable. The Bank’s right to receive the 2018 Letter Success Fee and the Borrower’s obligation to pay such 2018 Letter Success Fee terminate on the fifth anniversary of the funding of the Term B Loan, and shall survive the termination of the Amended and Restated Loan and Security Agreement and any prepayment of the Term Loans. Long-term debt consists of the following at September 30, 2018: Principal amount $ 10,000,000 Less unamortized debt acquisition costs (113,811 ) Plus accrued final fee 31,250 Subtotal 9,917,439 Less Current maturities – Long-term debt net of current maturities $ 9,917,439 Principal payments of long-term debt are due as follows at September 30, 2018: 2019 $ – 2020 3,666,667 2021 4,000,000 2022 2,333,333 Total $ 10,000,000 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 6. COMMITMENTS AND CONTINGENCIES Employment Agreements On July 14, 2015, CytoSorbents Corporation entered into 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 these agreements has an initial term of three years, and is retroactively effective as of January 1, 2015. After 2017, these employment agreements automatically renew for one year, unless terminated by the Company or the employee. 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. These 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 such terms are defined in each agreement. The agreements also provide for certain benefits in the event of a “Change of Control” of the Company, as such term is defined in each agreement. Litigation The Company is from time to time subject to claims and litigation arising out of the ordinary course of business. The Company intends to defend vigorously against any future claims and litigation. The Company is not currently a party to any 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 three months ended September 30, 2018 and 2017, the Company has recorded royalty costs of approximately $152,000 and $101,000, respectfully. For the nine months ended September 30, 2018 and 2017, the Company has recorded royalty costs of approximately $438,000 and $267,000, respectively. License Agreements In March 2006, the Company entered into a license agreement which provides the Company the exclusive right to use its patented technology and proprietary know how relating to adsorbent polymers for a period of 18 years. Under the terms of the agreement, the Company has agreed to pay royalties of 2.5% to 5% on the sale of certain of its products if and when those products are sold commercially for a term not greater than 18 years commencing with the first sale of such product. For the three months ended September 30, 2018 and 2017, per the terms of the license agreement, the Company has recorded royalty costs of approximately $253,000 and $169,000, respectfully. For the nine months ended September 30, 2018 and 2017, the Company recorded royalty costs of approximately $731,000 and $446,000, respectively. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 9 Months Ended |
Sep. 30, 2018 | |
Earnings Per Share [Abstract] | |
NET LOSS PER SHARE | 7. NET LOSS PER SHARE Basic loss per share and diluted loss per share for the three months ended September 30, 2018 and 2017 have been computed by dividing the net loss for each respective period by the weighted average number of shares outstanding during that period. All outstanding warrants and options and restricted stock awards representing approximately 4,800,000 and 4,949,000 incremental shares at September 30, 2018 and 2017 have been excluded from the computation of diluted loss per share as they are anti-dilutive. |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 9 Months Ended |
Sep. 30, 2018 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENT | 8. SUBSEQUENT EVENT From October 1, 2018 through October 31, 2018, the Company sold 17,030 shares of its common stock at an average cost of $12.69 per share under the terms of its Sales Agreement. The sales of these shares generated net proceeds of approximately $209,000 (See Note 3). |
PRINCIPAL BUSINESS ACTIVITY A_2
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Nature of Business | Nature of Business The Company is a leader in critical care immunotherapy using blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world. The Company, through its subsidiary CytoSorbents Medical, Inc. (formerly known as CytoSorbents, Inc.), is engaged in the research, development and commercialization of medical devices with its blood purification technology platform which incorporates a proprietary adsorbent, porous polymer technology. The Company, through its wholly owned European subsidiary, CytoSorbents Europe GmbH, conducts sales and marketing related operations for the CytoSorb device. In March 2016, the Company formed CytoSorbents Switzerland GmbH, a wholly-owned subsidiary of CytoSorbents Europe GmbH. This subsidiary, which began operations during the second quarter of 2016, provides marketing and direct sales services in Switzerland. CytoSorb, the Company’s flagship product, was approved in the in March 2011,and is currently being marketed in and distributed in fifty-three countries around the world, as a safe and effective extracorporeal cytokine absorber, designed to reduce the “cytokine storm” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. In May 2018, the Company received a label extension for CytoSorb covering use of the device for the removal of bilirubin and myoglobin which allows for the use of the device in the treatment of liver failure and trauma, respectively. CytoSorb is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. The technology is based upon biocompatible, highly porous polymer sorbent beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface absorption. The Company has numerous products under development based upon this unique blood purification technology, which is protected by 19 issued U.S. patents and multiple international patents, with applications pending both in the U.S. and internationally, including HemoDefend, ContrastSorb, DrugSorb, and others. These patents and patent applications are directed to various compositions and methods of use related to our blood purification technologies and are expected to expire between 2020 and 2035, absent any patent term extensions. Management believes that any near term expiring patents will not have a significant impact on our ongoing business. |
Stock Market Listing | Stock Market Listing On December 17, 2014 the Company’s common stock, par value $0.001 per share, was approved for listing on the Nasdaq Capital Market (“Nasdaq”), and it began trading on Nasdaq on December 23, 2014 under the symbol “CTSO.” Previously, the Company’s common stock traded in the over-the-counter-market on the OTC Bulletin Board. |
Basis of Consolidation and Foreign Currency Translation | Basis of Consolidation and Foreign Currency Translation The consolidated financial statements include the accounts of the parent, CytoSorbents Corporation, and its direct and indirect wholly-owned subsidiaries, CytoSorbents Medical, Inc, CytoSorbents Europe GmbH and CytoSorbents Switzerland GmbH. All significant intercompany transactions and balances have been eliminated in consolidation. Translation gains and losses resulting from the process of remeasuring into the U.S. dollar, the foreign currency financial statements of CytoSorbents Europe GmbH, for which the local currency is the functional currency, are included in other comprehensive income. Foreign currency transaction gains (loss) included in net loss amounted to approximately $(109,000) and $349,000 for the three months ended September 30, 2018 and 2017, respectively. Foreign currency transaction gains (loss) included in net loss amounted to approximately $(544,000) and $1,221,000 for the nine months ended September 30, 2018 and 2017, respectively. The Company translates assets and liabilities of CytoSorbents Europe GmbH, 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 stockholders’ equity as a component of accumulated other comprehensive income. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. |
Grants and Accounts Receivable | Grants and Accounts Receivable Grants receivable represent amounts due from U.S. government agencies and are included in Grants and Accounts Receivable. Accounts receivable are unsecured, non-interest bearing customer obligations due under normal trade terms. The Company sells its devices to various hospitals and distributors. The Company performs ongoing credit evaluations of its customers’ financial conditions. Management reviews accounts receivable periodically to determine collectability. Balances that are determined to be uncollectible are written off to the allowance for doubtful accounts. The allowance for doubtful accounts contains a general accrual for estimated bad debts and amounted to approximately $81,000 and $73,000 at September 30, 2018 and December 31, 2017, respectively. |
Inventories | Inventories Inventories are valued at the lower of cost or net realizable value under the first in, first out (FIFO) method. At September 30, 2018 and December 31, 2017, the Company’s inventory was comprised of finished goods, which amounted to $159,998 and $151,872, respectively; work in process which amounted to $390,497 and $528,039, respectively; and raw materials, which amounted to $228,930 and $115,746, 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 and successfully defend patents are capitalized. When patents are issued, capitalized costs are amortized on the straight-line method over the related patent term. In the event a patent is abandoned, the net book value of the patent is written off. |
Impairment or Disposal of Long-Lived Assets | Impairment or Disposal of Long-Lived Assets The Company assesses the impairment of patents and other long-lived assets under accounting standards for the impairment or disposal of long-lived assets whenever events or changes in circumstances indicate that the carrying value may not be recoverable. For long-lived assets to be held and used, the Company recognizes an impairment loss only if its carrying amount is not recoverable through its undiscounted cash flows and measures the impairment loss based on the difference between the carrying amount and fair value. |
Revenue Recognition | Revenue Recognition Product Sales : Revenues from sales of products to both direct and distributor/strategic partner customers are recognized at the time when control passes to the customer, in accordance with the terms of their respective contracts. Recognition of revenue occurs as each performance obligation is completed. Grant Income : Revenue from grant income is based on contractual agreements. Certain agreements provide for reimbursement of costs, while other agreements provide for reimbursement of costs and an overhead margin. 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 and research consultants are expensed when incurred. |
Advertising Expenses | Advertising Expenses Advertising expenses are charged to activities when incurred. Advertising expenses amounted to approximately $40,000 and $45,000 for the three months ended September 30, 2018 and 2017, respectively, and approximately $126,000 and $132,000 for the nine months ended September 30, 2018 and 2017, respectively, and are included in selling, general, and administrative expenses on the consolidated statement 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. The Company has provided a valuation allowance against all deferred tax assets. Under Section 382 of the Internal Revenue Code, the net operating losses generated prior to the previously completed reverse merger may be limited due to the change in ownership. Additionally, net operating losses generated subsequent to the reverse merger may be limited in the event of changes in ownership. The Tax Cuts and Job Act was enacted on December 22, 2017 and reduces the U.S. Federal corporate income tax rate from 35% to 21%. The Company follows accounting standards associated with uncertain tax positions. The Company had no unrecognized tax benefits at September 30, 2018 or December 31, 2017. The Company files tax returns in the U.S. federal and state jurisdictions. The Company utilizes the Technology Business Tax Certificate Transfer Program to sell a portion of its New Jersey Net Operating Loss carry forwards to an industrial company. Each of CytoSorbents Europe GmbH and CytoSorbents Switzerland GmbH files an annual corporate tax return, VAT return and a trade tax return in Germany and Switzerland, respectively. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities. Actual results could differ from these estimates. 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 4 for further information relating to the Company’s revenue.) As of September 30, 2018, one distributor accounted for approximately 14% of outstanding grants and accounts receivable. As of September 30, 2017, two distributors accounted for approximately 33% of outstanding grants and accounts receivable. As of December 31, 2017, two distributors accounted for approximately 28% of outstanding grants and accounts receivable. For the three and nine months ended September 30, 2018 and 2017, no agency, distributor, or direct customer represented more than 10% of the Company’s total revenue. |
Financial Instruments | Financial Instruments The carrying values of cash and cash equivalents, short-term investments, accounts payable, notes payable, and other debt obligations approximate their fair values due to their short-term nature. |
Net Loss Per Common Share | Net Loss Per Common Share Basic earnings per share is computed by dividing loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per common share is computed using the treasury stock method on the basis of the weighted-average number of shares of common stock plus the dilutive effect of potential common shares outstanding during the period. Dilutive potential common shares include outstanding warrants, stock options and restricted shares. The computation of diluted earnings per share does not assume conversion, exercise or contingent exercise of securities that would have an anti-dilutive effect on earnings (See Note 7). |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for its stock-based compensation under the recognition requirements of accounting standards for accounting for stock-based compensation, for employees and directors whereby each option granted is valued at fair market value on the date of grant. Under these accounting standards, the fair value of each option is estimated on the date of grant using the Black-Scholes option pricing model. The Company also follows the guidance of accounting standards for accounting for equity instruments that are issued to other than employees for acquiring, or in conjunction with selling, goods or services for equity instruments issued to consultants. |
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 has evaluated the impact of the updated guidance and has determined that the adoption of ASU 2016-02 is not expected to have a significant impact on its consolidated financial statements. |
Shipping and Handling Costs | Shipping and Handling Costs The cost of shipping product to customers and distributors is typically borne by the customer or distributor. The Company records other shipping and handling costs in cost of revenue. Total freight costs amounted to approximately $67,000 and $50,000, respectively, for the three months ended September 30, 2018 and 2017, and $273,000 and $178,000, respectively, for the nine months ended September 30, 2018 and 2017. |
Reclassifications | Reclassifications Certain reclassifications have been made to the September 30, 2017 financial statements in order to conform to the 2018 financial statement presentation. There was no change in the reported amount of the accumulated deficit as a result of these reclassifications. |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Stockholders' Equity Note [Abstract] | |
Schedule Of Share Based Compensation Stock Options Activity | The summary of the stock option activity for the nine months ended September 30, 2018 is as follows: Weighted Weighted Average Average Remaining Exercise Price Contractual Shares per Share Life (Years) Outstanding, December 31, 2017 3,578,538 $ 4.64 6.3 Granted 1,428,175 $ 7.98 9.5 Forfeited (55,324 ) $ 5.57 — Expired (800 ) $ 2.88 — Exercised (719,610 ) $ 3.78 — Outstanding, September 30, 2018 4,230,979 $ 5.90 7.3 |
Schedule of Share-based Compensation, Shares Authorized under Stock Option Plans, by Exercise Price Range | The intrinsic value is calculated at the difference between the market value as of September 30, 2018 of $12.90 and the exercise price of the shares. Options Outstanding Number Weighted Weighted Range of Outstanding at Average Average Aggregate Exercise September 30, Exercise Remaining Intrinsic Price 2018 Price Life (Years) Value $2.00 - $14.80 4,230,979 $ 5.90 7.3 $ 29,640,061 Options Exercisable Number Weighted Exercisable at Average Aggregate September 30, Exercise Intrinsic 2018 Price Value 2,501,456 $ 4.82 $ 20,253,186 |
Schedule Of Nonvested Share Activity | The summary of the status of the Company’s non-vested options for the nine months ended September 30, 2018 is as follows: Weighted Average Grant Date Shares Fair Value Non-vested, December 31, 2017 1,070,959 $ 0.70 Granted 1,428,175 $ 4.83 Forfeited (35,326 ) $ 2.43 Vested (734,285 ) $ 3.41 Non-vested, September 30, 2018 1,729,523 $ 4.52 |
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | The following table is a summary of these restricted stock units: Restricted Stock Units Board of Executive Other Directors Management Employees Total Intrinsic Value December 31, 2017 264,000 675,300 729,200 1,668,500 $ 10,845,250 Granted 13,200 49,200 329,350 391,750 Forfeited — — (42,750 ) (42,750 ) September 30, 2018 277,200 724,500 1,015,800 2,017,500 $ 26,025,750 |
Schedule Of Restricted Stock Unit Activity | The following table outlines the restricted stock unit activity for the nine months ended September 30, 2018: Weighted Average Grant Date Shares Fair Value Non-vested, January 1, 2018 110,003 $ 5.38 Granted 146,200 $ 7.85 Vested (117,065 ) $ 6.33 Non-vested, September 30, 2018 139,138 $ 7.18 |
Schedule Of Stockholders Equity Note Warrants and Common Stock Activity | As of September 30, 2018, the Company has the following warrants to purchase common stock outstanding: Number of Shares Warrant Exercise Warrant To be Purchased Price per Share Expiration Date 48,960 $ 7.500 March 11, 2019 351,398 $ 4.500 March 11, 2019 30,000 $ 9.900 January 14, 2020 430,358 |
REVENUE (Tables)
REVENUE (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregation of Revenue | The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended September 30, 2018: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ – $ – $ – $ – Germany 2,766,922 – – 2,766,922 All other countries 613,491 1,722,335 – 2,335,826 Total product revenue 3,380,413 1,722,335 – 5,102,748 Grant and other income: United States – – 640,225 640,225 Total revenue $ 3,380,413 $ 1,722,335 $ 640,225 $ 5,742,973 The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended September 30, 2017: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 32,200 $ – $ – $ 32,200 Germany 2,093,792 – – 2,093,792 All other countries 485,677 836,992 – 1,322,669 Total product revenue 2,611,669 836,992 – 3,448,661 Grant and other income: United States – – 375,638 375,638 Total revenue $ 2,611,669 $ 836,992 $ 375,638 $ 3,824,299 The following table disaggregates the Company’s revenue by customer type and geographic area for the nine months ended September 30, 2018: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 18,900 $ – $ – $ 18,900 Germany 8,686,596 – – 8,686,596 All other countries 2,034,080 4,042,023 – 6,076,103 Total product revenue 10,739,576 4,042,023 – 14,781,599 Grant and other income: United States – – 1,641,464 1,641,464 Total revenue $ 10,739,576 $ 4,042,023 $ 1,641,464 $ 16,423,063 The following table disaggregates the Company’s revenue by customer type and geographic area for the nine months ended September 30, 2017: United States Distributors/ Government Direct Strategic Partners Agencies Total Product sales: United States $ 56,200 $ – $ – $ 56,200 Germany 5,433,209 – – 5,433,209 All other countries 1,175,001 2,421,396 – 3,596,397 Total product revenue 6,664,410 2,421,396 – 9,085,806 Grant and other income: United States – – 1,418,237 1,418,237 Total revenue $ 6,664,410 $ 2,421,396 $ 1,418,237 $ 10,504,043 |
Contract with Customer, Asset and Liability | The following table provides information about receivables and contract liabilities from contracts with customers: September 30, 2018 December 31, 2017 Receivables, which are included in grants and accounts receivable $ 2,381,031 $ 1,267,459 Contract liabilities $ 35,113 $ 30,380 |
LONG-TERM DEBT, NET (Tables)
LONG-TERM DEBT, NET (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | Long-term debt consists of the following at September 30, 2018: Principal amount $ 10,000,000 Less unamortized debt acquisition costs (113,811 ) Plus accrued final fee 31,250 Subtotal 9,917,439 Less Current maturities – Long-term debt net of current maturities $ 9,917,439 |
Schedule of Principal payments of long-term debt | Principal payments of long-term debt are due as follows at September 30, 2018: 2019 $ – 2020 3,666,667 2021 4,000,000 2022 2,333,333 Total $ 10,000,000 |
BASIS OF PRESENTATION (Details
BASIS OF PRESENTATION (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
BASIS OF PRESENTATION [Line Items] | |||||
Accumulated deficit | $ (164,120,636) | $ (164,120,636) | $ (152,312,636) | ||
Net income (loss) | $ (3,004,762) | $ (2,054,279) | $ (11,808,000) | $ (5,313,780) |
PRINCIPAL BUSINESS ACTIVITY A_3
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 17, 2014 | |
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||||||
Common Stock, Par Value | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | |||
Foreign Currency Transaction Gain (Loss), before Tax | $ (108,903) | $ 348,546 | $ (544,177) | $ 1,221,334 | |||
Allowance for Doubtful Accounts Receivable | 80,873 | 80,873 | $ 72,698 | ||||
Inventory, Finished Goods, Gross | 159,998 | 159,998 | 151,872 | ||||
Inventory, Work in Process, Gross | 390,497 | 390,497 | 528,039 | ||||
Inventory, Raw Materials, Gross | 228,930 | 228,930 | $ 115,746 | ||||
Advertising Expense | 40,000 | 45,000 | 126,000 | 132,000 | |||
Cost of Goods and Services Sold | 2,052,696 | 1,516,864 | $ 5,406,195 | 4,253,357 | |||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 35.00% | ||||||
Cargo and Freight [Member] | |||||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||||||
Cost of Goods and Services Sold | $ 67,000 | $ 50,000 | $ 273,000 | $ 178,000 | |||
Scenario, Plan [Member] | |||||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | ||||||
Accounts Receivable [Member] | One Distributor [Member] | |||||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||||||
Concentration Risk, Percentage | 14.00% | ||||||
Accounts Receivable [Member] | Two Distributor [Member] | |||||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||||||
Concentration Risk, Percentage | 33.00% | 28.00% | |||||
Sales Revenue, Goods, Net [Member] | |||||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | |||||||
Concentration Risk, Percentage | 10.00% | 10.00% | 10.00% | 10.00% |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) | 9 Months Ended |
Sep. 30, 2018$ / sharesshares | |
Shares | |
Outstanding | shares | 3,578,538 |
Granted | shares | 1,428,175 |
Forfeited | shares | (55,324) |
Expired | shares | (800) |
Exercised | shares | (719,610) |
Outstanding | shares | 4,230,979 |
Weighted Average Exercise Price per Share | |
Outstanding | $ / shares | $ 4.64 |
Granted | $ / shares | 7.98 |
Forfeited | $ / shares | 5.57 |
Expired | $ / shares | 2.88 |
Exercised | $ / shares | 3.78 |
Outstanding | $ / shares | $ 5.90 |
Weighted Average Remaining Contractual Life (Years) | |
Outstanding | 6 years 3 months 18 days |
Granted | 9 years 6 months |
Forfeited | 0 years |
Expired | 0 years |
Exercised | 0 years |
Outstanding | 7 years 3 months 18 days |
STOCKHOLDERS' EQUITY (Details 1
STOCKHOLDERS' EQUITY (Details 1) | 9 Months Ended |
Sep. 30, 2018USD ($)$ / sharesshares | |
Options Outstanding | |
Number Outstanding at September 30, 2018 | shares | 4,230,979 |
Weighted Average Exercise Price | $ 5.90 |
Weighted Average Remaining Life (Years) | 7 years 3 months 18 days |
Aggregate Intrinsic Value | $ | $ 29,640,061 |
Options Exercisable | |
Number Exercisable at September 30, 2018 | shares | 2,501,456 |
Weighted Average Exercise Price | $ 4.82 |
Aggregate Intrinsic Value | $ | $ 20,253,186 |
$0.88 - $11.70 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Range of Exercise Price, Lower Range Limit | $ 2 |
Range of Exercise Price, Upper Range Limit | $ 14.80 |
STOCKHOLDERS' EQUITY (Details 2
STOCKHOLDERS' EQUITY (Details 2) - $ / shares | 1 Months Ended | 9 Months Ended |
Apr. 23, 2018 | Sep. 30, 2018 | |
Shares | ||
Non-vested, December 31, 2017 | 1,070,959 | |
Granted | 1,428,175 | |
Forfeited | (35,326) | |
Vested | (1,200,450) | (734,285) |
Non-vested, September 30, 2018 | 1,729,523 | |
Weighted Average Grant Date Fair Value | ||
Non-vested, December 31, 2017 | $ 0.70 | |
Granted | 4.83 | |
Forfeited | 2.43 | |
Vested | 3.41 | |
Non-vested, September 30, 2018 | $ 4.52 |
STOCKHOLDERS' EQUITY (Details 3
STOCKHOLDERS' EQUITY (Details 3) | 9 Months Ended |
Sep. 30, 2018USD ($)shares | |
Board of Directors [Member] | |
Restricted Stock Units, Forfeited | 0 |
Executive Management [Member] | |
Restricted Stock Units, Forfeited | 0 |
Restricted Stock Units (RSUs) [Member] | |
Restricted Stock Units, Beginning Balance | 1,668,500 |
Restricted Stock Units, Intrinsic Value Beginning Balance | $ | $ 10,845,250 |
Restricted Stock Units, Granted | 391,750 |
Restricted Stock Units, Forfeited | (42,750) |
Restricted Stock Units Ending Balance | 2,017,500 |
Restricted Stock Units, Intrinsic Value Ending Balance | $ | $ 26,025,750 |
Restricted Stock Units (RSUs) [Member] | Board of Directors [Member] | |
Restricted Stock Units, Beginning Balance | 264,000 |
Restricted Stock Units, Granted | 13,200 |
Restricted Stock Units Ending Balance | 277,200 |
Restricted Stock Units (RSUs) [Member] | Executive Management [Member] | |
Restricted Stock Units, Beginning Balance | 675,300 |
Restricted Stock Units, Granted | 49,200 |
Restricted Stock Units Ending Balance | 724,500 |
Restricted Stock Units (RSUs) [Member] | Other Employees [Member] | |
Restricted Stock Units, Beginning Balance | 729,200 |
Restricted Stock Units, Granted | 329,350 |
Restricted Stock Units, Forfeited | (42,750) |
Restricted Stock Units Ending Balance | 1,015,800 |
STOCKHOLDERS' EQUITY (Details 4
STOCKHOLDERS' EQUITY (Details 4) - Restricted Stock Units (RSUs) [Member] | 9 Months Ended |
Sep. 30, 2018$ / sharesshares | |
Shares | |
Non-vested, January 1, 2018 | shares | 110,003 |
Granted | shares | 146,200 |
Vested | shares | (117,065) |
Non-vested, September 30, 2018 | shares | 139,138 |
Weighted Average Grant Date Fair Value | |
Non-vested, January 1, 2018 | $ / shares | $ 5.38 |
Granted | $ / shares | 7.85 |
Vested | $ / shares | 6.33 |
Non-vested, September 30, 2018 | $ / shares | $ 7.18 |
STOCKHOLDERS' EQUITY (Details 5
STOCKHOLDERS' EQUITY (Details 5) - $ / shares | 9 Months Ended | |
Sep. 30, 2018 | Mar. 11, 2014 | |
Class of Warrant or Right [Line Items] | ||
Number of Shares To be Purchased | 430,358 | |
Warrant Exercise Price per Share | $ 4.50 | |
Warrant 1 | ||
Class of Warrant or Right [Line Items] | ||
Number of Shares To be Purchased | 48,960 | |
Warrant Exercise Price per Share | $ 7.500 | |
Warrant Expiration Date | Mar. 11, 2019 | |
Warrant 2 | ||
Class of Warrant or Right [Line Items] | ||
Number of Shares To be Purchased | 351,398 | |
Warrant Exercise Price per Share | $ 4.500 | |
Warrant Expiration Date | Mar. 11, 2019 | |
Warrant 3 | ||
Class of Warrant or Right [Line Items] | ||
Number of Shares To be Purchased | 30,000 | |
Warrant Exercise Price per Share | $ 9.900 | |
Warrant Expiration Date | Jan. 14, 2020 |
STOCKHOLDERS' EQUITY (Details T
STOCKHOLDERS' EQUITY (Details Textual) - USD ($) | Mar. 15, 2018 | Apr. 11, 2017 | Apr. 05, 2017 | Oct. 31, 2018 | Apr. 23, 2018 | Feb. 28, 2018 | Feb. 24, 2017 | Jun. 07, 2016 | Dec. 31, 2015 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Jul. 29, 2015 | Dec. 31, 2014 | Mar. 11, 2014 |
Stockholders Equity [Line Items] | |||||||||||||||||
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 | 5,000,000 | 5,000,000 | |||||||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | ||||||||||||||||
Stock Issued During Period, Shares, New Issues | 333,333 | ||||||||||||||||
Stock Issued During Period, Value, New Issues | $ 13,916,963 | ||||||||||||||||
Proceeds from Issuance of Common Stock | $ 10,300,000 | ||||||||||||||||
Aggregate registered amount for offerings | $ 150,000,000 | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price | $ 12.90 | $ 12.90 | |||||||||||||||
Shares Issued, Price Per Share | $ 4.50 | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Minimum | 2.09% | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Maximum | 3.00% | ||||||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 926,000 | $ 926,000 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 531,900 | 668,550 | |||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | 545,693 | ||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 4.50 | ||||||||||||||||
Stock or Unit Option Plan Expense | 0 | 2,113,000 | |||||||||||||||
Preferred Stock Dividends and Other Adjustments | 0 | $ 0 | $ 0 | $ 335,731 | $ 335,731 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Number of Shares | 1,200,450 | 734,285 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Aggregate Intrinsic Value, Nonvested | $ 5,635,634 | $ 5,635,634 | |||||||||||||||
Milestones Percentage | 37.50% | 37.50% | |||||||||||||||
Sale of Stock,Period One [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Stock Issued During Period, Shares, New Issues | 28,880 | ||||||||||||||||
Stock Issued During Period, Value, New Issues | $ 225,000 | ||||||||||||||||
Sale of Stock,Period Two [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Stock Issued During Period, Shares, New Issues | 550,000 | ||||||||||||||||
Stock Issued During Period, Value, New Issues | $ 3,367,000 | ||||||||||||||||
Sale of Stock, Price Per Share | $ 6.31 | ||||||||||||||||
Sale of Stock,Period Three [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Stock Issued During Period, Shares, New Issues | 1,498,320 | ||||||||||||||||
Stock Issued During Period, Value, New Issues | $ 13,917,000 | ||||||||||||||||
Sale of Stock, Price Per Share | $ 9.58 | $ 9.58 | |||||||||||||||
Shelf Registration [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Proceeds from Issuance of Common Stock | $ 10,000,000 | ||||||||||||||||
Over-Allotment Option [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Proceeds from Issuance of Common Stock | 1,500,000 | ||||||||||||||||
Common Stock Including Additional Paid in Capital [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Stock Issued During Period, Value, New Issues | $ 11,500,000 | ||||||||||||||||
Common Stock Including Additional Paid in Capital [Member] | Shelf Registration [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Stock Issued During Period, Shares, New Issues | 2,222,222 | ||||||||||||||||
Restricted Stock Units (RSUs) [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | $ 96,000 | $ 223,000 | |||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 146,200 | 125,000 | 80,000 | ||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ 1,148,000 | $ 700,000 | $ 375,200 | ||||||||||||||
Research and Development Expense [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Allocated Share-based Compensation Expense | 274,000 | 960,000 | 2,864,000 | 1,851,000 | |||||||||||||
Cantor Fitzgerald and Co. [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Commission Rate As Percentage Of Aggregate Gross Proceeds | 3.00% | ||||||||||||||||
Maximum Amount To Be Reimbursed For Expenses In Connection With Agreement | $ 50,000 | ||||||||||||||||
Minimum [Member] | Restricted Stock Units (RSUs) [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | $ 58,000 | $ 58,000 | $ 271,000 | $ 175,000 | |||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Forfeited | 14,000 | 240,000 | 77,000 | ||||||||||||||
Exercise Price Ranging From 6.85 to 11.70 [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 0 years | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | ||||||||||||||||
Exercise Price Ranging From 6.85 to 11.70 [Member] | Maximum [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price | $ 14.80 | $ 14.80 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 66.40% | ||||||||||||||||
Exercise Price Ranging From 6.85 to 11.70 [Member] | Minimum [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price | $ 6.85 | $ 6.85 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 61.60% | ||||||||||||||||
Subsequent Event [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Stock Issued During Period, Value, New Issues | $ 209,000 | ||||||||||||||||
Sale of Stock, Price Per Share | $ 8.72 | ||||||||||||||||
Sale of Stock, Number of Shares Issued in Transaction | 2,094,230 | ||||||||||||||||
Sale of Stock, Consideration Received on Transaction | $ 17,718,000 | ||||||||||||||||
Subsequent Event [Member] | Sale of Stock,Period Four [Member] | |||||||||||||||||
Stockholders Equity [Line Items] | |||||||||||||||||
Stock Issued During Period, Shares, New Issues | 17,030 | ||||||||||||||||
Stock Issued During Period, Value, New Issues | $ 209,000 | ||||||||||||||||
Sale of Stock, Price Per Share | $ 12.69 |
REVENUE (Details)
REVENUE (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | $ 5,102,748 | $ 3,448,661 | $ 14,781,599 | $ 9,085,806 |
Grant and other income: | ||||
Revenue from Grants | 640,225 | 375,638 | 1,641,464 | 1,418,237 |
Total revenue | 5,742,973 | 3,824,299 | 16,423,063 | 10,504,043 |
United States | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | 0 | 32,200 | 18,900 | 56,200 |
Grant and other income: | ||||
Revenue from Grants | 640,225 | 375,638 | 1,641,464 | 1,418,237 |
Germany | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | 2,766,922 | 2,093,792 | 8,686,596 | 5,433,209 |
All other countries | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | 2,335,826 | 1,322,669 | 6,076,103 | 3,596,397 |
Direct [Member] | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | 3,380,413 | 2,611,669 | 10,739,576 | 6,664,410 |
Grant and other income: | ||||
Total revenue | 3,380,413 | 2,611,669 | 10,739,576 | 6,664,410 |
Direct [Member] | United States | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | 0 | 32,200 | 18,900 | 56,200 |
Grant and other income: | ||||
Revenue from Grants | 0 | 0 | 0 | 0 |
Direct [Member] | Germany | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | 2,766,922 | 2,093,792 | 8,686,596 | 5,433,209 |
Direct [Member] | All other countries | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | 613,491 | 485,677 | 2,034,080 | 1,175,001 |
Distributors and Strategic Partners [Member] | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | 1,722,335 | 836,992 | 4,042,023 | 2,421,396 |
Grant and other income: | ||||
Total revenue | 1,722,335 | 836,992 | 4,042,023 | 2,421,396 |
Distributors and Strategic Partners [Member] | United States | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | 0 | 0 | 0 | 0 |
Grant and other income: | ||||
Revenue from Grants | 0 | 0 | 0 | 0 |
Distributors and Strategic Partners [Member] | Germany | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | 0 | 0 | 0 | 0 |
Distributors and Strategic Partners [Member] | All other countries | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | 1,722,335 | 836,992 | 4,042,023 | 2,421,396 |
United States Government Agencies [Member] | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | 0 | 0 | 0 | 0 |
Grant and other income: | ||||
Total revenue | 640,225 | 375,638 | 1,641,464 | 1,418,237 |
United States Government Agencies [Member] | United States | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | 0 | 0 | 0 | 0 |
Grant and other income: | ||||
Revenue from Grants | 640,225 | 375,638 | 1,641,464 | 1,418,237 |
United States Government Agencies [Member] | Germany | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | 0 | 0 | 0 | 0 |
United States Government Agencies [Member] | All other countries | ||||
Product sales: | ||||
Revenue from Contract with Customer, Including Assessed Tax | $ 0 | $ 0 | $ 0 | $ 0 |
REVENUE (Details 1)
REVENUE (Details 1) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Receivables, which are included in grants and accounts receivable | $ 2,381,031 | $ 1,267,459 |
Contract liabilities | $ 35,113 | $ 30,380 |
REVENUE (Details Textual)
REVENUE (Details Textual) | 9 Months Ended |
Sep. 30, 2018 | |
Maximum [Member] | |
Term of Customer Contracts | 5 years |
Minimum [Member] | |
Term of Customer Contracts | 1 year |
LONG-TERM DEBT, NET (Details)
LONG-TERM DEBT, NET (Details) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Principal amount | $ 10,000,000 | |
Less unamortized debt acquisition costs | (113,811) | |
Plus accrued final fee | 31,250 | |
Subtotal | 9,917,439 | |
Less Current maturities | 0 | $ 4,000,000 |
Long-term debt net of current maturities | $ 9,917,439 | $ 5,992,141 |
LONG-TERM DEBT, NET (Details 1)
LONG-TERM DEBT, NET (Details 1) | Sep. 30, 2018USD ($) |
2,019 | $ 0 |
2,020 | 3,666,667 |
2,021 | 4,000,000 |
2,022 | 2,333,333 |
Total | $ 10,000,000 |
LONG-TERM DEBT, NET (Details Te
LONG-TERM DEBT, NET (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
May 23, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Mar. 29, 2018 | Jun. 30, 2016 | |
Debt Issuance Costs, Net | $ 113,811 | $ 113,811 | |||||
Long-term Debt | 9,917,439 | 9,917,439 | |||||
Stock Issued During Period, Shares, Other | 68,791 | ||||||
Other Noncash Expense | $ 637,000 | 637,000 | $ 0 | ||||
Term A Loan [Member] | |||||||
Debt Instrument, Interest Rate, Effective Percentage | 9.10% | ||||||
Non-Refundable Closing Fee [Member] | |||||||
Interest Expense, Debt | 8,129 | $ 7,558 | 23,807 | 22,413 | |||
Non-Refundable Final Fee [Member] | |||||||
Interest Expense, Debt | $ 15,625 | $ 18,229 | $ 49,479 | $ 33,854 | |||
Western Alliance Bank [Member] | |||||||
Debt Instrument, Face Amount | $ 15,000,000 | $ 10,000,000 | |||||
Debt Instrument, Interest Rate, Stated Percentage | 8.91% | 8.91% | |||||
Debt Issuance Costs, Net | $ 130,060 | $ 130,060 | |||||
Percentage Of Success fee | 6.37% | ||||||
Share Price | $ 8 | $ 8 | |||||
Term Loan Interest LIBRO Rate Adjusted Monthly | 3.66% | ||||||
Western Alliance Bank [Member] | First Anniversary [Member] | |||||||
Debt Instrument, Periodic Payment | $ 333,333 | ||||||
Percentage Of Prepayment Interest | 2.00% | 2.00% | |||||
Western Alliance Bank [Member] | Second Anniversary [Member] | |||||||
Percentage Of Prepayment Interest | 1.50% | 1.50% | |||||
Western Alliance Bank [Member] | Third Anniversary [Member] | |||||||
Percentage Of Prepayment Interest | 1.00% | 1.00% | |||||
Western Alliance Bank [Member] | Closing Fee [Member] | |||||||
Debt Issuance Costs, Net | $ 25,000 | $ 25,000 | |||||
Western Alliance Bank [Member] | Bank related Expenses [Member] | |||||||
Debt Issuance Costs, Net | 11,000 | 11,000 | |||||
Western Alliance Bank [Member] | Legal Expenses [Member] | |||||||
Debt Issuance Costs, Net | 20,050 | 20,050 | |||||
Long-term Debt | $ 85,938 | 85,938 | |||||
Western Alliance Bank [Member] | Term A Loan [Member] | |||||||
Debt Instrument, Face Amount | 10,000,000 | $ 5,000,000 | |||||
Western Alliance Bank [Member] | Term B Loan [Member] | |||||||
Debt Instrument, Face Amount | $ 5,000,000 | ||||||
Western Alliance Bank [Member] | Term B Loan [Member] | First Anniversary [Member] | |||||||
Debt Instrument, Periodic Payment | $ 625,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Textual) - USD ($) | Aug. 11, 2003 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 |
Commitments and Contingencies Disclosure [Line Items] | |||||
Term of License Agreement | 18 years | ||||
Royalty Agreements | |||||
Commitments and Contingencies Disclosure [Line Items] | |||||
Future royalty payment percentage on gross revenue | 3.00% | ||||
Royalty cost | $ 152,000 | $ 101,000 | $ 438,000 | $ 267,000 | |
Equity investment by an existing investor | $ 4,000,000 | ||||
License Agreement | |||||
Commitments and Contingencies Disclosure [Line Items] | |||||
Royalty rate, lower limit | 2.50% | 2.50% | |||
Royalty rate, upper limit | 5.00% | 5.00% | |||
Royalty cost | $ 253,000 | $ 169,000 | $ 731,000 | $ 446,000 |
NET LOSS PER SHARE (Details Tex
NET LOSS PER SHARE (Details Textual) - shares | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Stock Options, Warrants And Restricted Stock Awards [Member] | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 4,800,000 | 4,949,000 |
SUBSEQUENT EVENT (Details Textu
SUBSEQUENT EVENT (Details Textual) - USD ($) | Apr. 11, 2017 | Oct. 31, 2018 | Sep. 30, 2018 |
Subsequent Event [Line Items] | |||
Stock Issued During Period, Shares, New Issues | 333,333 | ||
Stock Issued During Period, Value, New Issues | $ 13,916,963 | ||
Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Stock Issued During Period, Value, New Issues | $ 209,000 | ||
Sale of Stock, Price Per Share | $ 8.72 | ||
Subsequent Event [Member] | Sale of Stock,Period Four [Member] | |||
Subsequent Event [Line Items] | |||
Stock Issued During Period, Shares, New Issues | 17,030 | ||
Stock Issued During Period, Value, New Issues | $ 209,000 | ||
Sale of Stock, Price Per Share | $ 12.69 |