Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 29, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Entity Registrant Name | Akers Biosciences, Inc. | ||
Entity Central Index Key | 0001321834 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity a Well-known Seasoned Issuer | No | ||
Entity a Voluntary Filer | No | ||
Entity's Reporting Status Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business Flag | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 36,419,135 | ||
Entity Common Stock, Shares Outstanding | 12,482,708 | ||
Trading symbol | AKER | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2018 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current Assets | ||
Cash | $ 181,755 | $ 438,432 |
Marketable Securities | 5,272,998 | 5,011,607 |
Trade Receivables, net | 176,326 | 964,671 |
Deposits and other receivables | 9,347 | 16,590 |
Inventories, net | 585,267 | 947,612 |
Prepaid expenses | 444,435 | 396,987 |
Total Current Assets | 6,670,128 | 7,775,899 |
Non-Current Assets | ||
Prepaid expenses | 298,256 | 120,118 |
Restricted Cash | 500,000 | |
Property, Plant and Equipment, net | 83,456 | 235,113 |
Intangible Assets, net | 243,411 | 1,130,667 |
Other Assets | 12,002 | 76,093 |
Total Non-Current Assets | 1,137,125 | 1,561,991 |
Total Assets | 7,807,253 | 9,337,890 |
Current Liabilities | ||
Trade and Other Payables | 1,973,500 | 1,785,037 |
Total Liabilities | 1,973,500 | 1,785,037 |
Commitments and Contingencies | ||
SHAREHOLDERS' EQUITY | ||
Convertible Preferred Stock, No par value, 50,000,000 shares authorized, 0 and 1,755 shares issued and outstanding as of December 31, 2018 and 2017 | 1,755,000 | |
Common Stock, No par value, 500,000,000 shares authorized, 12,482,708 and 5,534,692 issued and outstanding as of December 31, 2018 and 2017 | 121,554,547 | 110,647,169 |
Deferred Compensation | (3,469) | |
Comprehensive Loss | (25,913) | |
Accumulated Deficit | (115,694,881) | (104,845,847) |
Total Shareholders' Equity | 5,833,753 | 7,552,853 |
Total Liabilities and Shareholders' Equity | $ 7,807,253 | $ 9,337,890 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | ||
Convertible preferred stock, no par value | ||
Convertible preferred stock, shares authorized | 50,000,000 | 50,000,000 |
Convertible preferred stock, shares issued | 0 | 1,755 |
Convertible preferred stock, shares outstanding | 0 | 1,755 |
Common stock, no par value | ||
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 12,482,708 | 5,534,692 |
Common stock, shares outstanding | 12,482,708 | 5,534,692 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Revenues: | ||
Total Revenues | $ 1,665,570 | $ 3,354,712 |
Cost of Sales: | ||
Product Cost of Sales | (1,538,285) | (2,406,132) |
Gross Income | 127,285 | 948,580 |
Administrative Expenses | 5,666,018 | 4,082,313 |
Sales and Marketing Expenses | 1,782,315 | 2,048,571 |
Research and Development Expenses | 1,063,253 | 1,260,378 |
Litigation Settlement Expenses | 1,505,000 | |
Amortization of Non-Current Assets | 171,108 | 171,108 |
Loss from Operations | (10,060,409) | (6,613,790) |
Other (Income)/Expenses | ||
Impairment of Intangible Assets | 716,148 | |
Impairment of Other Assets | 64,092 | |
Loss on Disposal of Property and Equipment | 156,493 | |
Foreign Currency Transaction (Gain)/Loss | 6,726 | (1,659) |
Other Income | (4,172) | |
Loss on Investments | 15,178 | |
Warrant Modification Expense | 764,932 | |
Interest and Dividend Income | (165,840) | (10,753) |
Total Other Expense | 788,625 | 752,520 |
Loss Before Income Taxes | (10,849,034) | (7,366,310) |
Income Tax Benefit | ||
Net Loss Attributable to Common Shareholders | (10,849,034) | (7,366,310) |
Other Comprehensive Loss | ||
Net Unrealized Loss on Marketable Securities | (25,913) | |
Total Other Comprehensive Loss | (25,913) | |
Comprehensive Loss | $ (10,874,947) | $ (7,366,310) |
Basic and Diluted loss per common share | $ (0.99) | $ (6.29) |
Weighted average basic and diluted common shares outstanding | 10,973,830 | 1,171,683 |
Product Revenue [Member] | ||
Revenues: | ||
Total Revenues | $ 1,665,570 | $ 3,304,712 |
License Fees [Member] | ||
Revenues: | ||
Total Revenues | $ 50,000 |
Consolidated Statement of Chang
Consolidated Statement of Changes in Shareholder's Equity - USD ($) | Preferred Stock [Member] | Common Stock [Member] | Deferred Compensation [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income/(Loss) [Member] | Total |
Balance at Dec. 31, 2016 | $ 100,891,786 | $ (24,572) | $ (97,479,537) | $ 3,387,677 | ||
Balance, shares at Dec. 31, 2016 | 681,569 | |||||
Net loss | (7,366,310) | (7,366,310) | ||||
Public offering of common stock, net of offering costs of $494,406 | $ 1,652,994 | 1,652,994 | ||||
Public offering of common stock, net of offering costs of $494,406, shares | 223,688 | |||||
Private offering of common stock, net of offering costs | $ 1,760,317 | 1,760,317 | ||||
Private offering of common stock, net of offering costs, shares | 181,050 | |||||
Public offering of common and preferred stock, net of offering costs of $834,414 | $ 3,675,000 | $ 2,390,586 | 6,065,586 | |||
Public offering of common and preferred stock, net of offering costs of $834,414, shares | 3,675 | 2,691,962 | ||||
Warrant Modification | $ 764,932 | 764,932 | ||||
Exercise of warrants for common stock | $ 981,948 | 981,948 | ||||
Exercise of warrants for common stock, shares | 115,627 | |||||
Conversion of preferred stock to common stock | $ (1,920,000) | $ 1,920,000 | ||||
Conversion of preferred stock to common stock, shares | (1,920) | 1,602,658 | ||||
Amortization of deferred compensation | 21,103 | 21,103 | ||||
Issuance of stock grants to officers | $ 163,924 | 163,924 | ||||
Issuance of stock grants to officers, shares | 23,284 | |||||
Issuance of stock grants to key employees | $ 95,770 | 95,770 | ||||
Issuance of stock grants to key employees, shares | 13,604 | |||||
Issuance of non-qualified stock options to key employees | $ 17,274 | 17,274 | ||||
Issuance of non-qualified stock options for services to non-employees | 2,183 | 2,183 | ||||
Issuance of restricted stock for services for non-employees | $ 5,455 | 5,455 | ||||
Issuance of restricted stock for services for non-employees, shares | 1,250 | |||||
Balance at Dec. 31, 2017 | $ 1,755,000 | $ 110,647,169 | (3,469) | (104,845,847) | 7,552,853 | |
Balance, shares at Dec. 31, 2017 | 1,755 | 5,534,692 | ||||
Net loss | (10,849,034) | (10,849,034) | ||||
Private offering of common stock, net of offering costs | $ 1,950,000 | 1,950,000 | ||||
Private offering of common stock, net of offering costs, shares | 694,446 | |||||
Exercise of warrants for common stock | $ 7,155,200 | 7,155,200 | ||||
Exercise of warrants for common stock, shares | 4,778,015 | |||||
Conversion of preferred stock to common stock | $ (1,755,000) | $ 1,755,000 | ||||
Conversion of preferred stock to common stock, shares | (1,755) | 1,464,930 | ||||
Amortization of deferred compensation | 3,469 | 3,469 | ||||
Issuance of stock grants to key employees | $ 27,702 | 27,702 | ||||
Issuance of stock grants to key employees, shares | 10,625 | |||||
Stock-based compensation - stock options | $ 6,931 | 6,931 | ||||
Stock-based compensation - restricted stock | 12,545 | 12,545 | ||||
Net unrealized loss on marketable securities | (25,913) | (25,913) | ||||
Balance at Dec. 31, 2018 | $ 121,554,547 | $ (115,694,881) | $ (25,913) | $ 5,833,753 | ||
Balance, shares at Dec. 31, 2018 | 12,482,708 |
Consolidated Statement of Cha_2
Consolidated Statement of Changes in Shareholder's Equity (Parenthetical) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Public Offering [Member] | ||
Net offering cost | $ 494,406 | |
Public Offering [Member] | Preferred Stock [Member] | ||
Net offering cost | 834,414 | |
Private Offering [Member] | ||
Net offering cost | $ 50,000 | $ 267,443 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities | ||
Net loss | $ (10,849,034) | $ (7,366,310) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Accrued income on marketable securities | (11,011) | (1,412) |
Depreciation and amortization | 234,486 | 249,894 |
Disposal of property and equipment (net) | 156,493 | |
Impairment of intangible assets | 716,148 | |
Impairment of other assets | 64,092 | |
Reserve for obsolete inventory | 279,029 | 1,208,522 |
Reserve for doubtful accounts | 156,835 | 450,000 |
Expenses related to modification of warrants | 764,932 | |
Amortization of deferred compensation | 3,469 | 21,103 |
Share based compensation to employees - options | 6,931 | 17,274 |
Share based compensation to employees | 27,702 | 95,770 |
Share based compensation to officers | 163,924 | |
Share based compensation to non-employees - options | 2,183 | |
Share based compensation to non-employees | 12,545 | 5,455 |
Changes in assets and liabilities: | ||
(Increase)/decrease in trade receivables | 631,510 | (781,508) |
Decrease in deposits and other receivables | 7,243 | 7,192 |
(Increase)/decrease in inventories | 83,316 | (119,613) |
(Increase)/decrease in prepaid expenses | (225,586) | 123,855 |
Increase in other assets | (9,280) | |
Increase in trade and other payables | 188,462 | 87,607 |
Net cash used in operating activities | (8,517,370) | (5,080,412) |
Cash flows from investing activities | ||
Purchases of property, plant and equipment | (68,214) | (54,507) |
Purchases of marketable securities | (6,589,623) | (7,709,341) |
Proceeds from sale of marketable securities | 6,313,330 | 2,749,147 |
Net cash consumed by investing activities | (344,507) | (5,014,701) |
Cash flows from financing activities | ||
Net proceeds from issuance of common stock | 1,950,000 | 5,803,897 |
Proceeds from issuance of preferred stock | 3,675,000 | |
Net proceeds from exercise of warrants for common stock | 7,155,200 | 981,948 |
Net cash provided by financing activities | 9,105,200 | 10,460,845 |
Net increase in cash and restricted cash | 243,323 | 365,732 |
Cash and restricted cash at beginning of year | 438,432 | 72,700 |
Cash and restricted cash at end of year | 681,755 | 438,432 |
Cash paid for: | ||
Interest | ||
Income Taxes | 2,070 | 1,706 |
Supplemental Schedule of Non-Cash Financing and Investing Activities | ||
Net unrealized gains/(losses) on marketable securities | (25,913) | |
Conversion of Series B Preferred Stock to common shares | $ 1,755,000 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | Note 1 – Organization and Description of Business Akers Biosciences, Inc. (“Akers”), is a New Jersey corporation. These consolidated financial statements include two wholly owned subsidiaries, Akers Acquisition Sub, Inc. and Bout Time Marketing Corporation, (together, the “Company”). All material intercompany transactions have been eliminated in consolidation. On November 7, 2018, the Company announced its intention to explore strategic alternatives in order to maximize shareholder value. As announced, this process will consider a range of potential strategic alternatives including, but not limited to, business combinations, while simultaneously supporting the Company’s management and employees in the execution of the Company’s current business activities. Furthermore, the Company has undertaken steps to reduce its expenses, including reducing the number of personnel, reducing its office footprint, eliminating services from non-critical vendors and a shareholder initiative to withdraw its shares from registration on the AIM exchange in the United Kingdom. The Company’s medical device business has as its current focus the production and sale of disposable diagnostic testing devices that can be performed in minutes, to facilitate time sensitive therapeutic decisions. The Company’s principal products are a rapid test detecting the antibody causing an allergic reaction to Heparin, breath alcohol detectors used for health and safety and a consumer product used to screen for levels of cholesterols. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Note 2 – Significant Accounting Policies (a) Basis of Presentation The accompanying consolidated financial statements for the years ended December 31, 2018 and 2017 have been prepared in accordance and in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding consolidated financial information. On November 8, 2018, the Company effectuated a reverse stock split of its shares of Common Stock whereby every eight (8) pre-split shares of Common Stock were exchanged for one (1) post-split share of the Company’s Common Stock (“Reverse Stock Split”). No fractional shares were issued in connection with the Reverse Stock Split. Shareholders who would otherwise have held a fractional share of the Common Stock were given one additional full share of the Company’s Common Stock. Numbers presented in these consolidated financial statements have been adjusted to reflect the Reverse Stock Split. (b) Use of Estimates and Judgments The preparation of financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. Information about significant areas of estimation, uncertainty and critical judgments in applying accounting policies that have the most significant effect on the amounts recognized in the financial statements are included in the following notes for revenue recognition, allowances for doubtful accounts, inventory valuations, impairment of intangible assets and valuation of share based payments. (c) Functional and Presentation Currency These consolidated financial statements are presented in U.S. Dollars, which is the Company’s functional currency. All financial information presented in U.S. Dollars has been rounded to the nearest dollar. Foreign Currency Transaction Gains or Losses, resulting from cash balances denominated in Foreign Currencies, are recorded in the consolidated statements of operations and comprehensive loss. (d) Comprehensive Income (Loss) The Company follows Financial Accounting Standards Board Accounting Standards Codification (“FASB ASC”) 220 in reporting comprehensive income (loss). Comprehensive income is a more inclusive financial reporting methodology that includes disclosure of certain financial information that historically has not been recognized in the calculation of net income. (e) Cash and Cash Equivalents The Company considers all highly liquid investments, which include short-term bank deposits (up to 3 months from date of deposit) that are not restricted as to withdrawal date or use, to be cash equivalents. (f) Restricted Cash At December 31, 2018, restricted cash included in non-current assets on the Company’s consolidated balance sheet was $500,000 representing cash in trust for the purpose of funding legal fees for certain litigations. (g) Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, marketable securities, receivables and trade and other payables. The carrying value of cash and cash equivalents, receivables and trade and other payables approximate their fair value because of their short maturities. The framework for measuring fair value provides a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1) and the lowest priority to unobservable inputs (level 3). The three levels of the fair value hierarchy under FASB ASC 820 are described as follows: Level 1 Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company has the ability to access. Level 2 Inputs to the valuation methodology include: ● quoted prices for similar assets or liabilities in active markets; ● quoted prices for identical or similar assets or liabilities in inactive markets; ● inputs other than quoted prices that are observable for the asset or liability; ● inputs that are derived principally from or corroborated by observable market data by correlation or other means If the asset or liability has a specified (contractual) term, the level 2 input must be observable for substantially the full term of the asset or liability. Level 3 Inputs to the valuation methodology are unobservable and significant to the fair value measurement. The asset or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of input that is significant to the fair value measurement. Valuation techniques maximize the use of relevant observable inputs and minimize the use of unobservable inputs. Following is a description of the valuation methodologies used for assets measured at fair value as of December 31, 2018 and 2017. U.S. Agency Securities: Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) Quoted Prices for Similar Assets or Liabilities in Active Markets (Level 2) Significant Unobservable Inputs (Level 3) Marketable securities at December 31, 2018 $ - $ 5,272,998 $ - Marketable securities at December 31, 2017 $ - $ 5,011,607 $ - Marketable securities include U.S. agency securities, which are classified as available for sale. The securities are valued at fair market value. Maturities of the securities are less than one year. Unrealized gains and losses relating to the available for sale investment securities were recorded in the Consolidated Statement of Changes in Shareholders’ Equity as comprehensive (loss) income. These amounts were an increase of $25,913 in unrealized losses for the year ended December 31, 2018 and $0 in unrealized loss for the year ended December 31, 2017. Gross gains and losses, resulting from these sales, amounted to a loss of $15,178 and a gain of $3,375 for the years ended December 31, 2018 and 2017, respectively. (h) Trade Receivables and Allowance for Doubtful Accounts The carrying amounts of current trade receivables is stated at cost, net of allowance for doubtful accounts and approximate their fair value given their short-term nature. The normal credit terms extended to customers ranges between 30 and 90 days. Credit terms longer than these may be extended after considering the credit worthiness of the customers and the business requirements. The Company reviews all receivables that exceed terms and establishes an allowance for doubtful accounts based on management’s assessment of the collectability of trade and other receivables. A considerable amount of judgment is required in assessing the amount of allowance. The Company considers the historical level of credit losses, makes judgments about the credit worthiness of each customer based on ongoing credit evaluations and monitors current economic trends that might impact the level of credit losses in the future. As of December 31, 2018 and 2017, allowances for doubtful accounts for trade receivables were $606,835 and $596,196. Bad debt expenses for trade receivables were $185,335 and $494,436 for the years ended December 31, 2018 and 2017. (i) Concentrations Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash on deposit with financial institutions and accounts receivable. At times, the Company’s cash in banks is in excess of the FDIC insurance limit. The Company has not experienced any loss as a result of these cash deposits. These cash balances are maintained with two banks. Major Customers For the year ended December 31, 2018, two customers generated 57% and 14%, or 71% in the aggregate, of the Company’s revenue. For the year ended December 31, 2017, three customers generated 32%, 26% and 15%, or 73% in the aggregate, of the Company’s revenue. Two customers accounted for 59% and 14%, or 73% in the aggregate, of gross trade receivables, before accounting for allowance for doubtful accounts, as of December 31, 2018. As of December 31, 2018, the Company had $458,902 and $111,037 in trade receivables, respectively, from these customers. These concentrations makes the Company vulnerable to a near-term severe impact should these relationships be terminated. To limit such risks, the Company performs ongoing credit evaluations of its customers’ financial condition. Major Suppliers For the year ended December 31, 2018, one supplier accounted for 14% of the Company’s purchases. For the year ended December 31, 2017, no suppliers accounted for 10% or more of the Company’s purchases. Two vendors accounted for 14% and 10%, or 24%, in the aggregate, of trade payables as of December 31, 2018. For the year ended December 31, 2017, no vendors accounted for 10% or more of the Company’s trade payables. (j) Property, Plant and Equipment Items of property, plant and equipment are measured at cost less accumulated depreciation and accumulated impairment losses. Costs include expenditures that are directly attributable to the acquisition of the asset. Gains and losses on disposal of an item of property, plant and equipment are determined by comparing the proceeds from disposal with the carrying amount of property, plant and equipment and are recognized within “other (income)/expense” in the consolidated statement of operations and comprehensive loss. Depreciation is recognized in the consolidated statements of operations and comprehensive loss on the accelerated basis over the estimated useful lives of the property, plant and equipment. Leased assets are depreciated over the shorter of the lease term or their useful lives. The estimated useful lives for the current and comparative periods are as follows: Useful Life (in years) Plant and equipment 5-12 Furniture and fixtures 5-10 Computer equipment & software 3-5 Shorter of the Leasehold Improvements remaining lease or estimated useful life Depreciation methods, useful lives and residual values are reviewed at each reporting date. (k) Intangible Assets The Company’s long-lived intangible assets, other than goodwill, are assessed for impairment when events or circumstances indicate there may be an impairment. These assets were initially recorded at their estimated fair value at the time of acquisition and assets not acquired in acquisitions were recorded at historical cost. However, if their estimated fair value is less than the carrying amount, other intangible assets with indefinite life are reduced to their estimated fair value through an impairment charge to the consolidated statements of operations and comprehensive loss. Patents and Trade Secrets The Company has developed or acquired several diagnostic tests that can detect the presence of various substances in a person’s breath, blood, urine and saliva. Propriety protection for the Company’s products, technology and process is important to its competitive position. As of December 31, 2018, the Company has ten patents from the United States Patent Office in effect (9,383,368; 7,896,167; 8,097,171; 8,003,061; 8,425,859; 8,871,521; 8,808,639; D691,056; D691,057 and D691,058). Other patents are in effect in Australia through the Design Registry (348,310; 348,311 and 348,312), European Union Patents 1793906, 2684025, 002216895-0001; 002216895-0002 and 002216895-0003), in Hong Kong (HK11004006) and in Japan (1,515,170; 4,885,134; 4,931,821 5,775,790, and 6023096). Patents are in the national phase of prosecution in many Patent Cooperation Treaty participating countries. Additional proprietary technology consists of numerous different inventions. Management intends to protect all other intellectual property (e.g. copyrights, trademarks and trade secrets) using all legal remedies available to the Company. Patent Costs Costs associated with applying for patents are capitalized as patent costs. Once the patents are approved, the respective costs are amortized over their estimated useful lives (maximum of 17 years) on a straight-line basis and assessed for impairment when necessary. Patent pending costs for patents that are not approved are charged to the consolidated statements of operations and comprehensive loss the year the patent is rejected. In addition, patents may be purchased from third parties. The costs of acquiring the patent are capitalized as patent costs if it represents a future economic benefit to the Company. Once a patent is acquired it is amortized over its remaining useful life and assessed for impairment when necessary. Other Intangible Assets Other intangible assets that are acquired by the Company, which have definite useful lives, are measured at cost less accumulated amortization and accumulated impairment losses. Amortization Amortization is recognized on a straight-line basis over the estimated useful lives of intangible assets, other than goodwill, from the date that they are available for use. The estimated useful lives for the current and comparative periods are as follows: Useful Life (in years) Patents and trademarks 12-17 Customer lists 5 (l) Recoverability of Long Lived Assets In accordance with FASB ASC 360-10-35 “Impairment or Disposal of Long-lived Assets”, long-lived assets to be held and used are analyzed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be fully recoverable or that the useful lives of those assets are no longer appropriate. The Company evaluates at each balance sheet date whether events and circumstances have occurred that indicate possible impairment. The Company determines the existence of such impairment by measuring the expected future cash flows (undiscounted and without interest charges) and comparing such amount to the carrying amount of the assets. An impairment loss, if one exists, is then measured as the amount by which the carrying amount of the asset exceeds the discounted estimated future cash flows. Assets to be disposed of are reported at the lower of the carrying amount or fair value of such assets less costs to sell. Asset impairment charges are recorded to reduce the carrying amount of the long-lived asset that will be sold or disposed of to their estimated fair values. Charges for the asset impairment reduce the carrying amount of the long-lived assets to their estimated salvage value in connection with the decision to dispose of such assets. (m) Investments In accordance with FASB ASC 323, the Company recognizes investments in joint ventures based upon the Company’s ability to significantly influence the operational or financial policies of the joint venture. An objective judgment of the level of influence is made at the time of the investment based upon several factors including, but not limited to the following: a) Representation on the Board of Directors b) Participation in policy-making processes c) Material intra-entity transactions d) Interchange of management personnel e) Technological dependencies f) Extent of ownership and the ability to influence decision making based upon the makeup of other owners when the shareholder group is small. The Company follows the equity method for valuating investments in joint ventures when the existence of significant influence over operational and financial policy has been established, as determined by management; otherwise, the Company will valuate these investments using the cost method. Investments recorded using the cost method will be assessed for any decrease in value that has occurred that is other than temporary and the other than temporary decrease in value shall be recognized. As and when circumstances and facts change, the Company will evaluate the Company’s ability to significantly influence operational and financial policy to establish a basis for converting the investment accounted for using the cost method to the equity method of valuation. (n) Revenue Recognition In accordance with FASB ASC 605, the Company recognizes revenue when (i) persuasive evidence of a customer or distributor arrangement exists, (ii) a retailer, distributor or wholesaler receives the goods and acceptance occurs, (iii) the price is fixed or determinable, and (iv) the collectability of the revenue is reasonably assured. Subject to these criteria, the Company recognizes revenue from product sales when title passes to the customer based on shipping terms. The Company typically does not accept returns nor offer charge backs or rebates except for certain distributors. Revenue recorded is net of any discount, rebate or sales return. The accrual for estimated sales returns was $57,446 and $0 as of December 31, 2018 and 2017, respectively. In cases where the right of return is granted and the Company does not have historical experience to reasonably estimate the sales returns, the revenue is recognized when the return privilege has substantially expired. The Company may provide for rebates to the distributors under limited circumstances. The Company established an accrual of $23,179 and $126,471, which is a reduction of revenue as of December 31, 2018 and 2017. Accounts receivable will be reduced when the rebates are applied by the customer. The Company recognized $105,247 and $296,164 during the years ended December 31, 2018 and 2017 for rebates, which is included as a reduction of product revenue in the Consolidated Statement of Operations and Comprehensive Loss. License fee revenue is recognized on a straight-line basis over the term of the license agreement. When the Company enters into arrangements that contain more than one deliverable, the Company allocates revenue to the separate elements under the arrangement based on their relative selling prices in accordance with FASB ASC 605-25. (o) Income Taxes The Company follows FASB ASC 740 when accounting for income taxes, which requires an asset and liability approach to financial accounting and reporting for income taxes. Deferred income tax assets and liabilities are computed annually for temporary differences between the financial statements and tax bases of assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense or benefit is the tax payable or refundable for the period plus or minus the change during the period in deferred tax assets and liabilities. (p) Shipping and Handling Fees and Costs The Company charges actual shipping costs plus a handling fee to customers, which amounted to $50,518 and $59,985 for the years ended December 31, 2018 and 2017. These fees are classified as part of product revenue in the Consolidated Statement of Operations and Comprehensive Loss. Shipping and other related delivery costs, including those for incoming raw materials are classified as part of the cost of net revenue, which amounted to $93,558 and $136,145 for the years ended December 31, 2018 and 2017, respectively. (q) Research and Development Costs In accordance with FASB ASC 730, research and development costs are expensed when incurred. (r) Stock-based Payments The Company accounts for stock-based compensation under the provisions of FASB ASC 718, “Compensation—Stock Compensation”, which requires the measurement and recognition of compensation expense for all stock-based awards made to employees and directors based on estimated fair values on the grant date. The Company estimates the fair value of stock-based awards on the date of grant using the Black-Scholes model. The value of the portion of the award that is scheduled to vest is recognized as expense over shorter of the period over which services are to be received or the vesting period. The Company accounts for stock-based compensation awards to non-employees in accordance with FASB ASC 505-50, “Equity-Based Payments to Non-Employees”. Under FASB ASC 505-50, the Company determines the fair value of the stock warrants or stock-based compensation awards granted as either the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measurable. The Company estimates the fair value of stock-based awards to non-employees on the date of grant using the Black-Scholes model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the period which services are to be received. At the end of each financial reporting period, prior to vesting or prior to completion of services, the fair value of equity based payments will be re-measured and the non-cash expense recognized during the period will be adjusted accordingly. Since the fair value of equity based payments granted to non-employees is subject to change in the future, the amount of the future expense will include fair value re-measurement until the equity based payments are fully vested or the service is completed. The Company has elected to account for forfeiture of stock based awards as they occur. (s) Basic and Diluted Earnings per Share of Common Stock Basic earnings per common share are based on the weighted average number of shares outstanding during the periods presented. Diluted earnings per share are computed using the weighted average number of common shares plus dilutive common share equivalents outstanding during the period. Potential common shares that would have the effect of increasing diluted earnings per share are considered anti-dilutive, i.e. the exercise prices of the outstanding stock options were greater than the market price of the Common Stock. The calculation of basic and diluted loss per share for the years ended December 31, 2018 and 2017 was based on the loss attributable to common shareholders of $10,849,034 and $7,366,310, respectively. The basic and diluted weighted average number of common shares outstanding for the years ended December 31, 2018 and 2017 was 10,973,830 and 1,171,683, respectively. Diluted net loss per share is computed using the weighted average number of common and dilutive potential common shares outstanding during the period. The following securities are excluded from the calculation of weighted average dilutive common shares because their inclusion would have been anti-dilutive: For the Years Ended December 31, 2018 2017 Incentive and Award Stock Options 10,502 31,875 Unvested Restricted Shares of Common Stock - 1,146 Warrants 2,110,737 6,186,471 Total potentially dilutive shares 2,121,239 6,219,492 (t) Recently Issued Accounting Pronouncements Recently Issued Accounting Pronouncements Adopted As the Company is an emerging growth company, it has elected to adopt recently issued accounting pronouncements based on effective dates applicable to other than public business entities. On March 30, 2016, the FASB issued ASU No. 2016-09, “Compensation – Stock Compensation (Topic 718)”. This update requires that all excess tax benefits and tax deficiencies arising from share-based payment awards should be recognized as income tax expense or benefit on the income statement. The amendment also states that excess tax benefits should be classified along with other income tax cash flows as an operating activity. In addition, an entity can make an entity-wide accounting policy election to either estimate the number of awards expected to vest or account for forfeitures as they occur. The provisions of this update are effective for annual and interim periods beginning after December 15, 2017. The Company adopted this standard effective January 1, 2018. The adoption did not have a material effect on the Company’s consolidated financial statements. In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230), Restricted Cash. The amendments in this Update require that a statement of cash flows explains the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of period and end-of-period total amounts shown on the statement of cash flows. The amendments in this Update do not provide a definition of restricted cash or restricted cash equivalents. The amendments in this Update are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2018, and interim periods within fiscal years beginning after December 15, 2019. Early adoption is permitted. The Company adopted this as of January 1, 2018 (See Note 2(f)). Recently Issued Accounting Pronouncements Not Adopted In May 2014 and April 2016, the FASB issued ASU No. 2014-09 and ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606). The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In August 2015, FASB issued ASU 2015-14 which deferred the effective date of Update 2014-09 to annual reporting periods beginning after December 15, 2018 for entities other than public business entities, and to annual reporting periods beginning after December 15, 2017, including interim reporting periods within that reporting period for public business entities. Early application is permitted as of annual reporting periods beginning after December 15, 2016 including interim reporting periods within that reporting period. The Company is currently evaluating the effect of the amendments, but it does not anticipate a material impact of its financial statements. The Company expects to use the modified retrospective adoption method and will adopt this Update as of January 1, 2019. In February 2016, the FASB issued ASU 2016-02—Leases (Topic 842) (“ASU-2016-02”), which requires an entity to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. ASU 2016-02 offers specific accounting guidance for a lessee, a lessor, and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. ASU 2016-02 is effective for annual reporting periods beginning after December 15, 2019, including interim periods within that reporting period, and requires a modified retrospective adoption, with early adoption permitted. The Company is currently evaluating the effect this guidance will have on its consolidated financial statements and related disclosure, and anticipates the guidance to result in increases in its assets and liabilities as most of its operating lease commitments will be subject to the new standard and recognized as right-of-use assets and lease liabilities. In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The guidance is effective for public business entities, certain not-for-profit entities, and certain employee benefit plans for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. For all other entities, ASU 2018-07 is effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company is evaluating the impact of adopting this pronouncement. In July 2018, the FASB issued ASU No. 2018-09, Codification Improvements, to makes changes to a variety of topics to clarify, correct errors in, or make minor improvements to the Accounting Standards Codification. Certain items of the amendments in ASU 2018-09 will be effective for the Company in annual periods beginning after December 15, 2018. The Company is currently evaluating the effects the adoption of ASU 2018-09 will have on the consolidated financial statements. |
Recent Developments and Managem
Recent Developments and Management's Plans | 12 Months Ended |
Dec. 31, 2018 | |
Recent Developments And Managements Plans | |
Recent Developments and Management's Plans | Note 3 – Recent Developments and Management’s Plans By way of a letter dated November 28, 2017, the Listing Qualifications Department of NASDAQ advised the Company that it did not comply with NASDAQ Listing Rule 5550(a)(2) for continued listing, because the Company’s Common Stock did not meet NASDAQ’s minimum $1.00 bid price requirement (the “Price Requirement”). The Company informed Nasdaq that the Company is fully committed to regain compliance with the Price Requirement as quickly as possible and, therefore, proposed to institute a reverse stock split. NASDAQ approved of the Company’s proposal of a reverse stock split and granted the Company until November 26, 2018, for the Company to be in compliance with the Price Requirement. The Company’s stock price did remain priced above $1.00 November 22, 2018, it is expected that Nasdaq, thereafter notified the Company that it had regained compliance with the NASDAQ Price Requirements. On April 25, 2018, the Board of Directors of the Company terminated Dr. Raymond F. Akers from his position as Executive Chairman of the Board and from each of his officer positions as Chief Scientific Director and Secretary of the Company. Dr. Raymond F. Akers continued as a member of the Board of Directors until his resignation on May 27, 2018. On April 25, 2018, the Board appointed Richard Carlyle Tarbox III, a director of the Company as the interim Non-Executive Chairman of the Board, to hold that position until his successor is appointed, and to the position of Secretary of the Company. By way of a letter dated May 22, 2018, the Listing Qualifications Department of NASDAQ advised the Company that it did not comply with NASDAQ Listing Rule 5250(c)(1) for continued listing because NASDAQ has not received the Company’s Quarterly Report. Company filed a Current Report on a Form 8-K with the Securities and Exchange Commission on May 25, 2018, that NASDAQ has informed the Company that the Company is required to submit a plan to regain compliance with NASDAQ’s filing requirements for continued listing within 60 calendar days of the date of the Notice. NASDAQ informed the Company that it is in Compliance with NASDAQ Listing Rule 5250(c)(1) on July 12, 2018. On June 11, 2018, the Company received a letter from the Listing Qualifications Department NASDAQ notifying the Company that it has determined that the Company violated the shareholder approval requirements of Listing Rule 5635(c). Listing Rule 5635(c) requires shareholder approval prior to the issuance of securities when a stock option or purchase plan is to be established or materially amended or other equity compensation arrangement made or materially amended, pursuant to which stock may be acquired by officers, directors, employees or consultants. Prior to the Company’s public offering and listing on NASDAQ, the Company’s 2013 Incentive Stock and Award Plan (the “2013 Plan”) was approved by its Board of Directors. NASDAQ has concluded that the 2013 Plan was materially amended on two occasions after the Company’s public offering and listing on NASDAQ. The first amendment, as approved by the Board on January 9, 2015, increased the number of shares available under the 2013 Plan from 50,000 to 100,000 shares and the second amendment, as approved by the Board on October 5, 2016, increased the number of shares under the 2013 Plan from 100,000 to 103,750 shares (the “2013 Plan Amendments”). During the first quarter of 2018, the Company promptly notified NASDAQ, as required by Listing Rule 5625, when it became aware of its potential non-compliance with Listing Rule 5635(c). On May 4, 2018, the Staff requested additional information from the Company with respect to such non-compliance and on May 31, 2018, the Company responded. On June 25, 2018, the Company submitted a plan to NASDAQ to remediate this matter (the “5635 Compliance Plan”). The 5635 Compliance Plan included that a proposal for shareholders of the Company to ratify the 2013 Plan Amendments be included in the proxy statement for the Company’s 2018 annual meeting of the shareholders of the Company and that the Company shall suspend the trading of each share granted, and each share granted upon the exercise of any option granted, in excess of 50,000 shares under the 2013 Plan (the number of shares properly approved pursuant to the 2013 Plan prior to the 2013 Plan Amendments until shareholder ratification). The 5635 Compliance Plan also proposes to prevent the exercise of any option granted under the 2013 Plan until shareholder ratification. On July 12, 2018, NASDAQ approved of the 5635 Compliance Plan and granted the Company until December 10, 2018, to regain compliance with Listing Rule 5635. The Company intends to have a shareholder meeting on December 7, 2018 to approve the amendments to the 2013 Plan. On December 7, 2018, the Company’s Shareholders approved the 2013 Plan. On or about June 15, 2018, certain parties brought certain class action lawsuits against the Company (See Note 11). On July 26, 2018, the Company implemented a reduction in workforce plan which resulted in the elimination of six staff positions in four operating departments. On September 6, 2018, with the recommendation of the Nominating and Corporate Governance Committee (the “N&G Committee”) of the Board appointed Mr. Joshua Silverman as a Director of the Company for a term that expires at the Company’s 2018 Annual Meeting of Stockholders, or until his earlier death, disability, resignation or removal. On September 17, 2018, the Company reached an amicable resolution by way of a settlement agreement and release (the “Settlement Agreement”) with Pulse Health, LLC, an Oregon limited liability company (the “Plaintiff”) with respect to the lawsuit Plaintiff filed against the Company, in the United States District Court, District of Oregon (the “Court”), Case No.:3:16-CV-01919-HZ (the “Litigation”), effective upon the Court entering a permanent injunction against the Company, which the Court has entered on to the docket on October 4, 2018. Pursuant to the settlement reached between the Plaintiff and the Company, on October 9, 2018 the Company paid $930,000 to the Plaintiff. The Company has also agreed to a permanent injunction and will not make, use, sell or offer to sell the BreathScan OxiChek™ product, any product that detects aldehydes or oxidative stress in exhaled human breath or breath condensate using either basic fuchsin or sodium metabisulfite or any form, analog or equivalent thereof, and the BreathScan Lync device, or any equivalent thereof, as part of a test for aldehydes or oxidative stress in human exhaled breath or breath condensate. The Company does not anticipate a material impact on revenues as a result of the withdrawal of the BreathScan OxiChek™ product from sale. The Settlement Agreement does not contain any admission of liability, wrongdoing, or responsibility by any of the parties. On October 5, 2018, John J. Gormally submitted to the Board his resignation from his position as the Chief Executive Officer of the Company and as a member of the Board, effective immediately. Mr. Gormally’s resignation was voluntary and not a result of any disagreement with the Company or its executive officers on any matter relating to the Company’s operations, policies or practices. In connection with his resignation from the Board, Mr. Gormally entered into a Resignation Agreement with the Company. Effective on October 5, 2018, the Board appointed Howard R. Yeaton, who through Financial Consulting Strategies LLC (“FCS”) served previously as a consultant to the Company, to serve as the Chief Executive Officer and interim Chief Financial Officer of the Company. Mr Yeaton is entitled to receive 3,750 shares per month as part of his compensation and 25,000 shares upon termination due to a change in control. On October 6, 2018, finnCap Ltd, the Company’s Nominated Adviser on the AIM market of the London Stock Exchange (“finnCap”), gave the Company formal three months’ notice of its resignation as the Company’s Nominated Adviser and Broker. Should finnCap cease to act as the Company’s Nominated Adviser and the Company does not appoint a replacement Nominated Adviser, the Company’s shares will be suspended from trading on AIM with immediate effect. The Company would then have one further month to appoint a replacement Nominated Adviser failing which the admission of its AIM securities will be cancelled. On December 19, 2018, the Company announced that finnCap had agreed to extend its notice period to March 31, 2019 so as to allow the Company sufficient time to proceed with a cancellation of its AIM listing. See below discussion of the Company’s withdrawal from AIM. On October 8, 2018, the Board, following a review of the Company’s commercial and product development strategies, determined that it is in the best interests of the Company to focus primarily on the sale of its Particle Immuno-Filtration Assay (PIFA®) Technology platform, which is also utilized in the Company’s core commercialized products, the PIFA® Heparin/PF4 and PIFA® Pluss/PF4 rapid assays, which test for an allergic reaction to Heparin. The Company will continue to manufacture BreathScan Alcohol Detectors (based on the Company’s Micro Particle Catalyzed (MPC®) Biosensor technology platform) and Tri-Cholesterol products (based on the Company’s Rapid Enzymatic Assay (REA™) technology platform. The Company is taking steps to improve its market presence for these products including the use of specialized independent sales representatives and through a program to educate the marketplace through the preparation and publication of additional clinical studies and physician seminars on the risks associated with heparin induced thrombocytopenia. On October 18, 2018, Richard C. Tarbox III submitted to the Board his resignation from his positions as interim Non-Executive Chairman of the Board, as Secretary of the Company, as a member of the Board and as a member of each of the committees of the Board upon which he serves, effective immediately. Mr. Tarbox’s resignation was voluntary and as a result of his other business commitments, and not a result of any disagreement with the Company or its executive officers on any matter relating to the Company’s operations, policies or practices. On October 19, 2018, as a result of Mr. Tarbox’s resignation from the Board and its committees the Board appointed Joshua Silverman to its Audit Committee, Compensation Committee, and Nominating and Corporate Governance Committee, having determined that he satisfies all applicable requirements to serve on such committees, including without limitation the applicable requirements of NASDAQ. On November 2, 2018, the Company entered into a securities purchase agreement with certain investors (the “Purchase Agreement”) pursuant to which the Company agreed to sell shares of Common Stock in addition to warrants to purchase shares of Common Stock (See Note 9). On November 7, 2018, the Company announced that its Board of Directors had initiated a process to evaluate strategic alternatives to maximize shareholder value. This process will consider a range of potential strategic alternatives including, but not limited to, business combinations, while simultaneously supporting the Company’s management and employees in the execution of the Company’s current business activities. There can be no assurance that the exploration of strategic alternatives will result in any transaction or other alternative. On December 19, 2018, the Company announced its intent to delist from the AIM Market of the London Stock Exchange. The Company believes that due to the relatively low liquidity in the Company’s common stock, reaming listed does not merit the ongoing costs and regulatory complexities associated with maintaining the AIM listing. On March 5, 2019, the Company held a special meeting of shareholders who then voted in favor of the Company delisting from the AIM Market. The delisting took effect on March 29, 2019. Historically, the Company has relied upon public offerings and private placements of Common Stock to raise operating capital. During the year ended December 31, 2017, the Company raised $9,478,897, net of expenses, in public and private offerings and an additional $981,948, net of expenses, from the exercise of warrants. During the first quarter of 2018, the Company raised an additional $7,155,200 from the exercise of warrants (Note 8). On November 2, 2018, the Company raised gross proceeds of $2,000,000 through the sale of 694,446 shares of the Company’s Common Stock. Each share includes a warrant to purchase one share of Common Stock at an exercise price of $3.76. As of March 22, 2019, the Company had cash and marketable securities of approximately $4.7 million (excluding restricted cash of $500,000) and working capital of approximately $4.6 million. The Company believes that its current working capital position will be sufficient to meet its obligations as they fall due within one year after these financial statements are issued. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Inventories | Note 4 – Inventories Inventories are measured at the lower of cost or net realizable value. The cost of inventories is based on the weighted-average principle, and includes expenditures incurred in acquiring the inventories, production or conversion costs and other costs incurred in bringing them to their existing location and condition. In the case of manufactured inventories and work in progress, costs include an appropriate share of production overhead based on normal operating capacity. Inventories consist of the following: December 31, 2018 December 31, 2017 Raw Materials $ 542,761 $ 458,441 Sub-Assemblies 711,181 886,274 Finished Goods 635,565 815,505 Reserve for Obsolescence (1,304,240 ) (1,212,608 ) $ 585,267 $ 947,612 Obsolete inventory charged to cost of goods during the years ended December 31, 2018 and 2017 totaled $453,761 and $1,208,522, respectively. For the year ended December 31, 2018, the Company reserved $279,031 of inventory, principally in connection with the removal of OxiChek from the market, which is included in cost of goods sold and wrote-off, against the reserve, $187,399 of inventory, principally the expired BreathScan Alcohol products, resulting in a net increase of $91,632 in the reserve for obsolescence as of December 31, 2018 compared to that as of December 31, 2017. The Company has been actively marketing, on a global basis, the BreathScan Breath Alcohol products that were produced for and/or acquired as part of the ChubeWorkx settlement agreement in August 2016. Unfortunately, the Company has not been successful in securing buyers in sufficient volumes. An extensive analysis of the market opportunity has been performed and it was determined that the on-hand quantity of this group of products exceeded the expected near term demand for the product prior to its expiration. As such, the Company’s management elected to establish a reserve of $1,182,400 for the year ended December 31, 2017. |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Note 5 - Property, Plant and Equipment Property, plant and equipment consists of the following: December 31, 2018 2017 Computer Equipment $ 17,514 $ 114,771 Computer Software 7,806 40,681 Office Equipment 39,959 39,959 Furniture & Fixtures 38,357 38,356 Machinery & Equipment 1,153,830 1,138,134 Molds & Dies 645,272 868,570 Leasehold Improvements 249,960 222,593 2,152,698 2,463,064 Less Accumulated Depreciation 2,069,242 2,227,951 $ 83,456 $ 235,113 Depreciation expense totaled $63,378 and $78,786 for the years ended December 31, 2018 and 2017, respectively. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Note 6 – Intangible Assets Intangible assets as of December 31, 2018 and 2017 are as follows: December 31, 2018 Cost or Accumulated Net Deemed Amortization Book Cost and Impairment Value Patents & Trademarks $ 2,626,996 $ (2,383,585 ) $ 243,411 Distributors & Customer Relationships 1,270,639 (1,270,639 ) - Total $ 3,897,635 $ (3,654,224 ) $ 243,411 December 31, 2017 Cost or Accumulated Net Deemed Amortization Book Cost and Impairment Value Patents & Trademarks $ 2,626,996 $ (1,496,329 ) $ 1,130,667 Distributors & Customer Relationships 1,270,639 (1,270,639 ) - Total $ 3,897,635 $ (2,766,968 ) $ 1,130,667 Intangible assets as of December 31, 2018 and 2017 were $243,411 and $1,130,667, respectively. Intangible assets at December 31, 2018 consisted of patents, trademarks and customer lists of $3,897,635 net of accumulated amortization and impairment of $3,654,224. Effective on October 9, 2018, the Company pulled the OxiChek product line from the market (See Note 3). This served as a triggering event for testing whether or not our intangible assets were impaired. The Company then performed a recoverability analysis and determined that as of December 31, 2018, there was an impairment of $716,148. Amortization is recognized on a straight-line basis over the estimated useful lives of intangible assets, other than goodwill, from the date that they are available for use. Amortization expense was $171,108 and $171,108 for the years ended December 31, 2018 and 2017, respectively. The following is an annual schedule of approximate future amortization of the Company’s intangible assets: Period Amount 2019 41,336 2020 41,336 2021 41,336 2022 41,336 2023 34,696 Thereafter 43,371 Total $ 243,411 |
Trade and Other Payables
Trade and Other Payables | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Trade and Other Payables | Note 7 - Trade and Other Payables Trade and other payables consists of the following: December 31, 2018 2017 Trade Payables $ 686,578 $ 988,772 Accrued Expenses 1,227,172 736,515 Deferred Compensation 59,750 59,750 $ 1,973,500 $ 1,785,037 See also Note 12 for related party information. |
Share-based Payments
Share-based Payments | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-based Payments | Note 8 - Share-based Payments On January 23, 2014, upon effectiveness of the registration statement filed with the SEC, the Company adopted the 2013 Stock Incentive Plan (the “Plan”) which will provide for the issuance of up to 50,000 shares. The purpose of the Plan is to provide additional incentive to those officers, employees, consultants and non-employee directors of the Company and its parents, subsidiaries and affiliates whose contributions are essential to the growth and success of the Company’s business. On January 9, 2015, the Board of Directors of the Company approved, upon recommendation from the Compensation Committee of the Board, by unanimous written consent the Amended and Restated 2013 Incentive Stock and Award Plan (the “Amended Plan”), which increases the number of authorized shares of Common Stock subject to the Plan to 100,000 shares. On September 30, 2016, the Board of Directors increased the number of authorized shares of Common Stock subject to the Amended Plan to 103,750 shares. As of December 31, 2018, grants of restricted stock and options to purchase 78,028 shares of Common Stock have been issued, pursuant to the Amended Plan, and are unvested or unexercised and 25,722 shares of Common Stock remain available for grants under the Amended Plan. On August 7, 2017, the Shareholders approved and the Company adopted the 2017 Equity Incentive Plan (the “2017 Plan”) which will provide for the issuance of up to 168,750 shares. The purpose of the Plan is to provide additional incentive to those officers, employees, consultants and non-employee directors of the Company and its parents, subsidiaries and affiliates whose contributions are essential to the growth and success of the Company’s business. As of December 31, 2018, grants totaling 36,032 shares of restricted Common Stock have been issued pursuant to the 2017 Plan and 132,718 shares of Common Stock remain available for grants under the Plan. On December 7, 2018, the Shareholders approved and the Company adopted the 2018 Equity Incentive Plan (the “2018 Plan”) which provides for the issuance of up to 1,875,000 shares. The purpose of the 2018 Plan is to provide additional incentive to those officers, employees, consultants and non-employee directors of the Company and its parents, subsidiaries and affiliates whose contributions are essential to the growth and success of the Company’s business. As of December 31, 2018, there were no grants under the 2018 Plan and 1,875,000 shares of Common Stock remain available for grants under the Plan. The Plans are administered by the Board or a Board-appointed committee. Eligible recipients of option awards are employees, officers, consultants or directors (including non-employee directors) of the Company or of any parent, subsidiary or affiliate of the Company. The Board has the authority to grant to any eligible recipient any options, restricted stock or other awards valued in whole or in part by reference to, or otherwise based on, the Company’s Common Stock. During the year ended December 31, 2018 the Company issued 10,625 shares of Common Stock under the above plans (See Note 9). Stock Options The following table summarizes the option activities for the year ended December 31, 2018: Weighted Average Weighted Weighted Remaining Number Average Average Contractual Aggregate of Exercise Grant Date Term Intrinsic Shares Price Fair Value (years) Value Balance at December 31, 2017 31,878 $ 33.98 $ 20.49 2.02 $ - Granted - - - - - Exercised - - - - - Forfeited (21,376 ) 35.74 22.00 0.82 - Canceled/Expired - - - - - Balance at December 31, 2018 10,502 $ 30.41 $ 17.42 1.43 $ - Exercisable as of December 31, 2018 10,502 $ 30.41 $ 17.42 1.43 $ - The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the closing stock price of $1.13 for the Company’s common shares on December 31, 2018. As of December 31, 2018, all of the Company’s outstanding stock options were fully vested and exercisable. During the years ended December 31, 2018 and 2017, the Company incurred stock option expenses totaling $6,931 and $19,457, respectively. Stock Warrants The table below summarizes the warrant activity for the year ended December 31, 2018: Average Weighted Remaining Number Average Contractual Aggregate of Exercise Term Intrinsic Warrants Price (years) Value Balance at December 31, 2017 6,186,471 $ 1.79 4.95 $ - Granted 694,446 3.76 - Exercised (4,770,180 ) 1.50 - Forfeited - - - Canceled/Expired - - - Balance at December 31, 2018 2,110,737 $ 3.10 4.21 $ - Exercisable as of December 31, 2018 2,110,737 $ 3.10 4.21 $ - The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the closing stock price of $1.13 for the Company’s common shares on December 31, 2018. All warrants were vested on date of grant. |
Equity
Equity | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Equity | Note 9 - Equity The holders of common shares are entitled to one vote per share at meetings of the Company. Holders of Series B convertible preferred shares had no voting rights at meetings of the Company. A restricted stock award is an award of common shares that are subject to certain restrictions during a specified period. Restricted stock awards are independent of option grants and are generally subject to forfeiture if employment terminates prior to the release of the restrictions. The grantee cannot transfer the shares before the restricted shares vest. Shares on non-vested restricted stock have the same voting rights as Common Stock, are entitled to receive dividends and other distributions thereon and are considered to be currently issued and outstanding. The Company expenses the cost of the restricted stock awards, which is determined to be the fair market value of the shares at the date of grant, straight-line over the period during which the restrictions lapse. For these purposes, the fair market value of the restricted stock is determined based on the closing price of the Company’s Common Stock on the grant date. On January 13, 2017, the Company completed a public offering of 223,688 common shares, raising net proceeds of $1,652,994. In addition to the common shares issued, the Company also issued 111,844 warrants with an exercise price of $12.00 per common share. All of the warrants issued have a five-year term. On March 30, 2017, the Company completed a private placement of 181,050 unregistered shares of Common Stock, raising net proceeds of $1,760,317. The unregistered shares were admitted to trading on September 30, 2017 upon notification from the Securities and Exchange Commission that the Registration Statement, filed April 19, 2017, had been deemed effective. In addition to the common shares issued, the Company also issued 99,578 warrants with an exercise price of $15.68 per common share with a five-year term. On April 11, 2017, the Company issued 1,250 restricted shares to a consultant for services to be rendered during the year ending December 31, 2017. These shares vested on the date of the grant. The fair value of these shares was $18,000 and was based on the share price on the date of the grant. During the year ended December 31, 2017, $5,455 was recognized as stock-based compensation expense. The remaining $12,545 fair value of restricted shares issued was recognized during the three months ended March 31, 2018 as sales and marketing expenses on the Consolidated Statement of Operations and Comprehensive Loss. On October 12, 2017, the Company entered into Warrant Exercise Agreements with the existing holders of 90,525 warrants from the March 2017 private placement with an original exercise price of $15.68 per share to exercise their current warrants at $8.00 per share and receive a new warrant which would be convertible into the same number of common shares as the original warrant. The new warrant has an exercise price of $10.08 and expire five years from the date of issuance. The increase in fair value of the reduction in the exercise price of the warrants from $15.68 to $8.00 was $93,386. The Company used the Black-Scholes option pricing model to calculate the increase in fair value with the following assumptions for the decrease in exercise price: no dividend yield, expected volatility of 97.16%, risk free interest rate of 1.95%, and expected warrant life of 4.47 years. The fair value of the new warrants issued of 90,525 was $671,546. The Company used the Black-Scholes option pricing model to calculate the fair value with the following assumptions for the issuance of the new warrants: no dividend yield, expected volatility of 97.16%, risk free interest rate of 1.95%, and expected warrant life of 5 years. In accordance with FASB ASC 718-20-35, expenses related to the modification and re-issue of the warrants totaled $764,932 which are included as warrant modification expenses on the Consolidated Statement of Operations and Comprehensive Loss. The Company received net proceeds of $680,748 net of a solicitation fee of $43,452 from the exercise of 90,525 warrants. On October 17, 2017, the Board of Directors issued 36,888 restricted shares of Common Stock to key employees and officers of the Company as part of the 2017 Equity Incentive Plan. The restricted stock vested immediately and were valued at the closing stock price of $7.04 per share. The fair value of the restricted shares totaled $259,694 and were expensed immediately. On December 21, 2017, the Company completed a public offering of 2,691,962 common shares and 3,675 Series B convertible preferred shares, raising net proceeds of $6,065,586. In addition to the common shares issued, the Company also issued 5,750,000 warrants with an exercise price of $1.50 per common share in support of the base offering. All the warrants issued have a five-year term. During the year ended December 31, 2017, 1,920 shares of the Company’s Series B Preferred Stock, no par value, were converted into 1,602,658 shares of Common Stock at an exercise price of $1.50 per share. During the year ended December 31, 2017, warrant holders from the January 13, 2017 public offering exercised 25,101 warrants with an exercise price of $12.00 per common share, raising net proceeds of $301,200. During the year ended December 31, 2018, the Company issued 7,500 shares of Common Stock to Mr. Yeaton pursuant to his employment agreement. These shares had a fair value of $16,702 on date of grant. During the year ended December 31, 2018, the Company issued 3,125 shares of Common Stock to a former executive officer of the Company. These shares had a fair value of $11,000 on date of grant. On November 2, 2018, the Company entered into the Purchase Agreement pursuant to which the Company agreed to sell an aggregate of 694,446 shares of Common Stock and warrants to purchase approximately 694,446 shares of Common Stock (the “Warrants”). The combined purchase price for one share of Common Stock and each Warrant was priced at $2.88 (the “Offering”). The Purchase Agreement contains customary representations, warranties, and covenants by the Company. Through the Offering, the Company raised proceeds of $1,950,000, net of offering costs of $50,000. Each Warrant has an initial exercise price of $3.76 per share, will be exercisable immediately after the date of issuance and will expire five years from the date it becomes exercisable. Subject to limited exceptions, a holder of the Warrants will not have the right to exercise any portion of such securities if the holder, together with its affiliates, would beneficially own in excess of 4.99% of the number of shares of the Company’s Common Stock outstanding immediately after the exercise. The exercise price of the Warrants, and in some cases the number of shares of Common Stock issuable upon exercise of the Warrants, will be subject to adjustment in the event of stock splits, stock dividends, combinations, rights offerings and similar events affecting the Common Stock. In addition, the Warrants provide that, in the event of a fundamental transaction (as such term is described in the Warrant), the holder of such Warrant, at the holder’s option, may receive, for each warrant share (as such term is described in the Warrant) that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental transaction, the number of shares of Common Stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration receivable as a result of such fundamental transaction by a holder of the number of shares of Common Stock for which the Warrant is exercisable immediately prior to such fundamental transaction. If holders of Common Stock are given any choice as to the securities, cash or property to be received in a fundamental transaction, then the holder shall be given the same choice as to the alternate consideration it receives upon any exercise of the Warrant following such fundamental transaction. The Company shall cause any successor entity (as such term is described in the Warrant), at the option of the holder, to deliver to the holder in exchange for the Warrant a security of the successor entity evidenced by a written instrument substantially similar in form and substance to the Warrant which is exercisable for a corresponding number of shares of capital stock of such successor entity (or its parent entity) equivalent to the shares of Common Stock acquirable and receivable upon exercise of the Warrant (without regard to any limitations on the exercise of this Warrant) prior to such fundamental transaction, and with an exercise price which applies the exercise price hereunder to such shares of capital stock. The Offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-214214), previously filed with the Securities and Exchange Commission on October 24, 2016 and declared effective on November 16, 2016. Such securities are being offered only by means of a prospectus. On November 7, 2018, effective as of November 8, 2018, the Company filed a Certificate of Amendment (the “Certificate of Amendment”) to its Amended and Restated Certificate of Incorporation with the Secretary of State of the State of New Jersey to effect a reverse stock split of its Common Stock at a ratio of eight-for-one (8-for-1). As a result of the reverse stock split, there are approximately 12,482,708 shares of Common Stock outstanding. The reverse stock split affected all shareholders uniformly and did not alter any shareholder’spercentage interest in the Company’s equity, except to the extent that the reverse stock split would have resulted in a shareholder owning a fractional share. Fractional shares have not been issued as a result of the reverse stock split; instead, the board of directors of the Company determined to effect an issuance of shares to holders that would otherwise have been entitled to a fractional share such that any fractional shares were rounded up to the nearest whole number. During the year ended December 31, 2018, 1,755 shares of the Company’s Series B Preferred Stock, no par value, were converted into 1,464,930 shares of Common Stock. During the year ended December 31, 2018, warrant holders from the December 21, 2017 public offering exercised 4,778,015 warrants with an exercise price of $1.50 per common share, raising net proceeds of $7,155,200. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 10 - Income Taxes The Company’s income tax (benefit)/provision is as follows: Years Ended December 31, 2018 2017 Current $ - $ - Deferred (2,941,000 ) $ (6,003,000 ) Change in Valuation Allowance 2,941,000 $ 6,003,000 Income Tax Benefit $ - $ - The reconciliation of income taxes using the statutory U.S. income tax rate and the benefit from income taxes for the years ended December 31, 2018 and 2017 are as follows: Years Ended December 31, 2018 2017 Statutory U.S. Federal Income Tax Rate (21.0 )% (35.0 )% New Jersey State income taxes, net of U.S. Federal tax effect (5.1 )% (6.0 )% Disallowed research and development expenditures 0.1 % - % True-up for prior year deferred tax assets (0.9 )% - % Research and development tax credit (0.2 )% - % Tax rate change - % 122.0 % Change in Valuation Allowance 27.1 % (81.0 )% Net 0.0 % 0.0 % In December 2017, the Tax Cuts and Jobs Act was enacted, which reduced the U.S. statutory corporate tax rate to 21% for tax years beginning in 2018. This change resulted in a re-measurement of the federal portion of the Company’s deferred tax assets and the valuation allowance as of December 31, 2017 from 35% to the new 21% tax rate. As of December 31, 2018 and 2017, the Company had Federal net operating loss carry forwards of approximately $80,500,000 and $69,001,000, expiring through the year ending December 31, 2038. As of December 31, 2018 and 2017, the Company had New Jersey state net operating loss carry forwards of approximately $29,700,000 and $19,392,000, expiring through the year ending December 31, 2025. The timing and manner in which the Company can utilize operating loss carryforwards in any year may be limited by provisions of the Internal Revenue Code regarding changes in ownership of corporations. Such limitation may have an impact on the ultimate realization of its carryforwards and future tax deductions. The principal components of the deferred tax assets and related valuation allowances as of December 31, 2018 and 2017 are as follows: Years Ended December 31, 2018 2017 Reserves and other $ 523,000 $ 718,000 Net operating loss carry-forwards 18,417,000 15,762,000 Research and development tax credit 481,000 - Valuation Allowance (19,421,000 ) (16,480,000 ) Net $ - $ - The valuation allowance for deferred tax assets as of December 31, 2018 and 2017 was $21,894,000 and $16,480,000. The change in the total valuation for the years ended December 31, 2018 and 2017 was an increase of $2,941,000 and a decrease of $6,003,000, respectively. In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which the net operating losses and temporary differences become deductible. Management considered projected future taxable income and tax planning strategies in making this assessment. The value of the deferred tax assets was fully offset by a valuation allowance, due to the current uncertainty of the future realization of the deferred tax assets. The Company’s policy is to record interest and penalties associated with unrecognized tax benefits as additional income taxes in the statement of operations. As of January 1, 2018, the Company had no unrecognized tax benefits and no charge during 2018, and accordingly, the Company did not recognize any interest or penalties during 2018 related to unrecognized tax benefits. There is no accrual for uncertain tax positions as of December 31, 2018. The Company files U.S. federal income tax returns and a state income tax returns. The U.S. and state income tax returns filed for the tax years ending on December 31, 2015 and thereafter are subject to examination by the relevant taxing authorities. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 11 – Commitments and Contingencies Lease Commitments The Company leases its facility in West Deptford, New Jersey under an operating lease (“Thorofare Lease”) with annual rentals of $132,000 plus common area maintenance (CAM) charges. The lease, which took effect on January 1, 2008, reduced the CAM charges allowing the Company to reach their own agreements with utilities and other maintenance providers. On January 7, 2013, the Company extended its lease agreement for a term of 7 years, expiring December 31, 2019. Rent expense for the Thorofare Lease, including related CAM charges for the years ended December 31, 2018 and 2017 totaled $164,996 and $161,807, respectively. The Company entered into a 24-month lease for a satellite office located in Ramsey, New Jersey (“Ramsey Lease”) with annual rents of $25,980 plus common area maintenance (CAM) charges. The lease took effect on June 1, 2017 and runs through May 31, 2019. Rent expenses for the Ramsey Lease, including related CAM charges totaled $25,980 and $25,980 for the years ended December 31, 2018 and 2017, respectively. The Company posted a security deposit of $4,330 which is included in other assets on the Consolidated Balance Sheet. The Company entered into a 29-month lease for warehouse space located in Pitman, New Jersey (“Pitman Lease”) with annual rents of $39,650. The lease took effect on August 1, 2017 and runs through December 31, 2019. Rent expenses for the Pitman Lease totaled $40,245 and $16,670 for the years ended December 31, 2018 and 2017, respectively. A security deposit of $4,950 is included in other assets on the Consolidated Balance Sheet. The Company entered into a 60-month operating lease for equipment with annual rentals of $6,156 on September 29, 2014. The lease commenced on October 21, 2014 upon the delivery of the equipment. The schedule of lease commitments is as follows: Thorofare Ramsey Pitman Equipment Lease Lease Lease Lease Total Next 12 Months $ 132,000 $ 4,330 $ 39,650 $ 5,130 $ 181,110 ChubeWorkx On August 17, 2016, pursuant to a Settlement Agreement (the “Settlement Agreement”) with ChubeWorkx Guernsey Limited (“ChubeWorkx”), which settled all pending claims between the Company and ChubeWorkx. Specifically, the Company and ChubeWorkx agreed to voluntarily dismiss (i) the action in the United States Federal Court, District of New Jersey brought by the Company against ChubeWorkx for outstanding amounts due to the Company under a promissory note and (ii) the action in The High Court of Justice, Queen’s Bench Division Commercial Court, Royal Courts of Justice, United Kingdom brought by ChubeWorkx against the Company arising from an exclusive licensing agreement between ChubeWorkx and the Company (“Licensing Agreement”). In return for the Company regaining the full rights to sell breath technology products, under the terms of the Settlement Agreement, ChubeWorkx is entitled to receive a royalty of 5% of the Company’s gross revenues (the “ChubeWorkx Royalty”) until ChubeWorkx has earned an aggregate $5,000,000, after which point ChubeWorkx will no longer be entitled to receive any royalties from the Company and the Company shall have no further obligation to ChubeWorkx. The Settlement Agreement further allows the Company to retain 50% of the ChubeWorkx Royalty until the full $549,609 cash component of the monies owed by ChubeWorkx to the Company as described above has been satisfied. The Company recorded royalty expenses of $59,584 and $202,126 for the years ended December 31, 2018 and 2017, respectively, which are included in sales and marketing expenses on the Consolidated Statement of Operations and Comprehensive Loss. As of December 31, 2018, the Company owed ChubeWorkx royalties of $9,083 which is included in trade and other payables. Other terms of the Settlement included: 1) the pledge as security of all earned but unpaid royalties by the Company to ChubeWorkx all Company assets, worthy to satisfy its obligations, including all inventory and receivables, with the exception of (i) distribution contracts of the Company or any of its affiliates, (ii) customer lists, (iii) manufacturing processes (including all intellectual property required to use those processes and exploit products made thereby), and (iv) all equipment required to perform said manufacturing processes and other equipment; 2) the pledge as security of the settlement sum which remains unpaid by the Company to ChubeWorkx all Company (i) distribution contracts of the Company or any of its affiliates, (ii) customer lists, (iii) manufacturing processes (including all intellectual property required to use those processes and exploit products made thereby), and (iv) all equipment required to perform said manufacturing processes and other equipment; and 3) the grant of voting proxy by ChubeWorkx to the Company which allows the Company to vote ChubeWorkx’s shares for corporate formalities under certain conditions. The pledged assets are only at risk in the event that the Company cannot satisfy any outstanding royalty payment obligations subject to various cure periods and/or through a restructuring and/or liquidation under the United States Bankruptcy laws of the Company in favor of payment of said obligation. Litigation and Settlements Pulse Health On October 17, 2016 the Company was served with a notice that Pulse Health LLC (“Pulse”) filed a lawsuit against the Company on September 30, 2016 in United States Federal District Court, District of Oregon, alleging a breach of contract under the settlement agreement entered into by the Company and Pulse on April 8, 2011 which settled all claims and disputes between the Company and Pulse arising from a previously executed Technology Development Agreement entered into by the Company and Pulse and damages resulting from said alleged breach. Additionally, Pulse alleges false advertising and unlawful trade practices in connection with the Company’s sales activities related to the Company’s OxiChek™ products. The Company filed a series of motions with the Court seeking (1) to dismiss the Pulse complaint for lack of jurisdiction or, in the alternative, transfer the matter to the District Court for the District of New Jersey, Camden Vicinage and (2) to dismiss the unfair competition claims for failure to state a claim on which relief could be granted. Oral arguments on these motions were heard by the Court on March 10, 2017. The Court decided by order dated April 14, 2017 in favor of the Company and has dismissed with prejudice the claims brought by Pulse for unfair competition (both federal and state counts). The court decided against the Company in its motions for transfer of venue and for lack of jurisdiction. As such, the case shall proceed in the District Court of Oregon. The Company filed a Motion for Summary Judgment on January 24, 2018. On June 21, 2018, the Court ruled in favor of the Company on some issues and determined that other issues warranted a trial. As part of its ruling on the Motion for Summary Judgment, the Court held “While it seems likely that Plaintiff did suffer some amount of damages, Plaintiff has so far failed to provide a sufficient evidentiary foundation from which the trier of fact could reasonably calculate the value of its injury.” The Court stated that it was “reasonably certain that Plaintiff suffered some damage” and found that Pulse Health “may be entitled to nominal damages.” The Court further determined that equitable relief, such as an injunction, “may be warranted.” Following such rulings, the Company discovered certain deficiencies in its discovery responses and took the appropriate steps to supplement the record and correct these deficiencies. In addition, the Court had ordered a settlement conference in front of a U.S. magistrate that was held on August 31, 2018. On September 17, 2018, the Company and Pulse entered into a settlement. Pursuant to the settlement reached between the Plaintiff and the Company, the Company accrued $930,000 payable to Pulse as of September 30, 2018, which was paid on October 9, 2018. The Company has also agreed to a permanent injunction and will not make, use, sell or offer to sell the BreathScan OxiChek™ product, any product that detects aldehydes or oxidative stress in exhaled human breath or breath condensate using either basic fuchsin or sodium metabisulfite or any form, analog or equivalent thereof, and the BreathScan Lync device, or any equivalent thereof, as part of a test for aldehydes or oxidative stress in human exhaled breath or breath condensate. The Company does not anticipate a material impact on revenues as a result of the withdrawal of the BreathScan OxiChek™ product from sale. The Settlement Agreement does not contain any admission of liability, wrongdoing, or responsibility by any of the parties. Faulkner v. Akers Biosciences, Inc., No. 2:18-cv-10521 (D.N.J.) and Gleason v. Akers Biosciences, Inc., No. 2:18-cv-10805 (D.N.J.) On June 13, 2018, Plaintiff Tim Faulkner filed a class action complaint alleging securities violations against Akers Biosciences, Inc. (“Akers”), John J. Gormally, and Gary M. Rauch (“Individual Defendants”) (together with Akers, “Defendants”) on behalf of all persons and entities who purchased publicly traded Akers securities from May 15, 2017 through June 5, 2018 (the “Faulkner Action”). The complaint alleges violations of Section 10(b) of the Exchange Act and Rule 10b-5 against all Defendants, and violations of Section 20(a) of the Exchange Act against the Individual Defendants. In particular, the complaint alleges that Defendants made false and/or misleading statements and/or failed to disclose in its first, second, and third quarter 2017 10-Qs and its 2017 10-K that: (1) Akers was improperly recognizing revenue for the fiscal year ended December 31, 2017; and, (2) Akers had downplayed weaknesses in its internal controls over financial reporting and failed to disclose the true extent of those weaknesses. On June 20, 2018, Plaintiff David Gleason filed a class action complaint under the caption Gleason v. Akers Biosciences, Inc., No. 2:18-cv-10805 (D.N.J.) based on the same allegations and causes of action (the “Gleason Action”). On November 21, 2018, the Faulkner and Gleason Actions were consolidated under the Faulkner Action docket. The parties conducted a mediation on January 10, 2019, and agreed to a settlement in principle disposing of the consolidated action as to all Defendants, including the Individual Defendants. On March 8, 2019, the parties signed a settlement agreement, subject to approval by the Court, whereby the Company agreed to pay $2,250,000 in exchange for full releases and discharge of all claims against the Company. On the same day, Lead Plaintiffs filed a motion for preliminary approval of the settlement and to establish notice procedures. That motion remains pending. Watts v. Gormally, et al., No. 2:18-15992 (D.N.J.) On November 9, 2018, Plaintiff Cale Watts filed a verified shareholder derivative complaint alleging violations of the Securities Exchange Act of 1934, breach of fiduciary duty, unjust enrichment, and waste of corporate assets based on alleged material weaknesses in controls, management, and documentation (the “Watts Action”). On January 14, 2019, the parties reached an agreement in principle to settle the Watts Action that included corporate reforms and a payment of attorneys’ fees of $200,000. The parties finalized a Stipulation of Settlement on March 4, 2019. On March 22, 2019, Plaintiffs filed a motion for preliminary approval of the proposed Settlement, approving the proposed form and method of providing notice of the settlement, scheduling a hearing for final approval of the settlement. That motion remains pending. Chan v. Gormally, et al., No. 2:19-cv-4989 (D.N.J.) On February 7, 2019, Tiffany Chan, Jasmine Henderson, and Don Danesh filed a verified shareholder derivative complaint alleging violations of Section 14(a) of the Exchange Act and SEC Rule 14a-9, breach of fiduciary duty, unjust enrichment, and waste of corporate assets based on the same circumstances as the Watts Action. The Chan Action further alleges that the Company should not have settled the Watts Action because the Watts Action plaintiffs lacked standing and the settlement would cause irreparable harm to the Company and its shareholders. Defendants must respond to the Chan Action by April 9, 2019. Faulkner, Gleason, Watts and Chan Matters As of December 31, 2018, with regard to the Faulkner, Gleason, Watts and Chan matters, the Company believes that other than the Company’s retention requirement under its D&O liability insurance coverage of $500,000, the Company has no additional liability. The D&O liability insurance coverage provides insurance coverage to both the Company and the Directors and Officers for covered defense and indemnification. Furthermore, during the year ended December 31, 2018, the Company recorded a charge of $500,000, representing the full amount of such retention requirement. Therefore, assuming that the settlements are approved, as discussed above, the Company believes it has no further liability with respect to these matters. Typenex Medical, LLC v. Akers Biosciences, Inc., JAMS Ref. No. 1450005929 On November 15, 2018, Typenex Medical LLC (“Typenex”), a telemarketing entity with whom the Company had entered into a marketing and commission agreement dated September 30, 2016 (the “Marketing Contract”), filed an arbitration against the Company before JAMS ADR (the “Arbitration”), and an arbiter was appointed to the Arbitration on December 14, 2018. In the Arbitration, Typenex has stated that it seeks “at least” $220,500 based on the allegation that the Marketing Contract entitles Typenex to a commission on sales of certain of the Company’s heparin-related products in the period two years from the Marketing Contract’s expiration, and in the alternative, Typenex seeks relief for breach of the implied covenant of good faith and fair dealing, and/or unjust enrichment. The Company vigorously opposes Typenex’s interpretation of the Marketing Contract and will continue to defend this action in the Arbitration. Other A former executive has threatened to sue the Company and executives over the termination of executive’s employment and for contractual severance pay. The executive asserts that the Company terminated the executive for using sick leave in violation of New Jersey law and that the termination was without cause within the meaning of an employment agreement which provides for severance of one year’s salary in the event of termination without cause. With respect to this matter, the Company believes that the ultimate liability from the settlement of this matter will not be material to the Company’s consolidated financial statements. Subsequent to December 31, 2018, a former executive threatened to sue the Company over the termination of the executive’s employment. The executive contends that the termination was in retaliation for complaints to the employer protected under the California whistleblower protection laws. The executive also contends that the Company failed to pay a bonus in violation of an employment contract. The Company’s management and legal counsel believes it is too early to determine the probable outcome of this matter. The Company intends to establish a rigorous defense of all claims. All legal fees were expensed as and when incurred. |
Related Parties
Related Parties | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Parties | Note 12 – Related Parties Hainan Savvy On March 9, 2015, the Company contributed capital of $64,091 to Hainan Savy Akers Biosciences, Ltd. (“Hainan”), a company incorporated in the People’s Republic of China, resulting in an initial 19.9% ownership interest. On December 31, 2018, the Company recorded a charge of $64,091 for the full impairment of its investment in Hainan. This investment was included in other assets in the Consolidated Balance Sheet as of December 31, 2017 and the investment was accounted for using the cost method. The Company began purchasing manufacturing molds and plastic components through Hainan and its related party during the year ended December 31, 2016. The Company purchased a total of $20,936 and $41,731 in such components during the years ended December 31, 2018 and 2017, respectively. As of December 31, 2018, the Company owed Hainan and its related party $0 which was included in trade and other payables. CEO and Interim CFO Effective on October 5, 2018, the Board appointed Howard R. Yeaton, to serve as the Chief Executive Officer and interim Chief Financial Officer of the Company (See Note 3). Mr. Yeaton is the managing principal of FCS and the Company’s relationship with FCS shall continue, with FCS continuing to provide accounting services to the Company. FCS is considered to be a related party. During the year ended December 31, 2018, the Company expensed $ to FCS in connection with these services. As of December 31, 2018, the Company owed FCS $29,407 |
Revenue Information
Revenue Information | 12 Months Ended |
Dec. 31, 2018 | |
Segment Reporting [Abstract] | |
Revenue Information | Note 13 – Revenue Information Revenue by product lines was as follows: Years Ended December 31, Product Line 2018 2017 MicroParticle Catalyzed Biosensor (“MPC”) $ 123,941 $ 381,228 Particle ImmunoFiltration Assay (“PIFA”) 1,422,361 2,232,684 Rapid Enzymatic Assay (“REA”) 68,750 133,848 Other 50,518 556,952 Product Revenue Total 1,665,570 3,304,712 License Fees - 50,000 Total Revenue $ 1,665,570 $ 3,354,712 The total revenue by geographic area determined based on the location of the customers was as follows: Years Ended December 31, Geographic Region 2018 2017 United States $ 1,576,765 $ 2,679,549 People’s Republic of China - 502,131 Rest of World 88,805 173,032 Total Revenue $ 1,665,570 $ 3,354,712 The Company had long-lived assets totaling $14,294 and $59,830 located in the People’s Republic of China and $312,573 and $1,305,950 located in the United States as of December 31, 2018 and 2017, respectively. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | Note 14 – Employee Benefit Plan The Company maintains a defined contribution benefit plan under section 401(k) of the Internal Revenue Code covering substantially all qualified employees of the Company (the “401(k) Plan”). Under the 401(k) Plan, the Company matches 100% up to a 3% contribution, and 50% over a 3% contribution, up to a maximum of 5%. During the year ended December 31, 2018, the Company made contributions to the 401(k) Plan of $55,360. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 15 – Subsequent Events On March 29, 2019, the Compensation Committee of the Board of Directors was granted 124,827 Restricted Stock Units (“RSU”). Such RSUs shall vest on January 1, 2020, with vesting accelerated upon a change of control. Such RSUs are able to be settled in cash or stock, including on a net tax basis, at the discretion of the holder. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | (a) Basis of Presentation The accompanying consolidated financial statements for the years ended December 31, 2018 and 2017 have been prepared in accordance and in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding consolidated financial information. On November 8, 2018, the Company effectuated a reverse stock split of its shares of Common Stock whereby every eight (8) pre-split shares of Common Stock were exchanged for one (1) post-split share of the Company’s Common Stock (“Reverse Stock Split”). No fractional shares were issued in connection with the Reverse Stock Split. Shareholders who would otherwise have held a fractional share of the Common Stock were given one additional full share of the Company’s Common Stock. Numbers presented in these consolidated financial statements have been adjusted to reflect the Reverse Stock Split. |
Use of Estimates and Judgments | (b) Use of Estimates and Judgments The preparation of financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. Information about significant areas of estimation, uncertainty and critical judgments in applying accounting policies that have the most significant effect on the amounts recognized in the financial statements are included in the following notes for revenue recognition, allowances for doubtful accounts, inventory valuations, impairment of intangible assets and valuation of share based payments. |
Functional and Presentation Currency | (c) Functional and Presentation Currency These consolidated financial statements are presented in U.S. Dollars, which is the Company’s functional currency. All financial information presented in U.S. Dollars has been rounded to the nearest dollar. Foreign Currency Transaction Gains or Losses, resulting from cash balances denominated in Foreign Currencies, are recorded in the consolidated statements of operations and comprehensive loss. |
Comprehensive Income (Loss) | (d) Comprehensive Income (Loss) The Company follows Financial Accounting Standards Board Accounting Standards Codification (“FASB ASC”) 220 in reporting comprehensive income (loss). Comprehensive income is a more inclusive financial reporting methodology that includes disclosure of certain financial information that historically has not been recognized in the calculation of net income. |
Cash and Cash Equivalents | (e) Cash and Cash Equivalents The Company considers all highly liquid investments, which include short-term bank deposits (up to 3 months from date of deposit) that are not restricted as to withdrawal date or use, to be cash equivalents. |
Restricted Cash | (f) Restricted Cash At December 31, 2018, restricted cash included in non-current assets on the Company’s consolidated balance sheet was $500,000 representing cash in trust for the purpose of funding legal fees for certain litigations. |
Fair Value of Financial Instruments | (g) Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, marketable securities, receivables and trade and other payables. The carrying value of cash and cash equivalents, receivables and trade and other payables approximate their fair value because of their short maturities. The framework for measuring fair value provides a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1) and the lowest priority to unobservable inputs (level 3). The three levels of the fair value hierarchy under FASB ASC 820 are described as follows: Level 1 Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company has the ability to access. Level 2 Inputs to the valuation methodology include: ● quoted prices for similar assets or liabilities in active markets; ● quoted prices for identical or similar assets or liabilities in inactive markets; ● inputs other than quoted prices that are observable for the asset or liability; ● inputs that are derived principally from or corroborated by observable market data by correlation or other means If the asset or liability has a specified (contractual) term, the level 2 input must be observable for substantially the full term of the asset or liability. Level 3 Inputs to the valuation methodology are unobservable and significant to the fair value measurement. The asset or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of input that is significant to the fair value measurement. Valuation techniques maximize the use of relevant observable inputs and minimize the use of unobservable inputs. Following is a description of the valuation methodologies used for assets measured at fair value as of December 31, 2018 and 2017. U.S. Agency Securities: Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) Quoted Prices for Similar Assets or Liabilities in Active Markets (Level 2) Significant Unobservable Inputs (Level 3) Marketable securities at December 31, 2018 $ - $ 5,272,998 $ - Marketable securities at December 31, 2017 $ - $ 5,011,607 $ - Marketable securities include U.S. agency securities, which are classified as available for sale. The securities are valued at fair market value. Maturities of the securities are less than one year. Unrealized gains and losses relating to the available for sale investment securities were recorded in the Consolidated Statement of Changes in Shareholders’ Equity as comprehensive (loss) income. These amounts were an increase of $25,913 in unrealized losses for the year ended December 31, 2018 and $0 in unrealized loss for the year ended December 31, 2017. Gross gains and losses, resulting from these sales, amounted to a loss of $15,178 and a gain of $3,375 for the years ended December 31, 2018 and 2017, respectively. |
Trade Receivables and Allowance for Doubtful Accounts | (h) Trade Receivables and Allowance for Doubtful Accounts The carrying amounts of current trade receivables is stated at cost, net of allowance for doubtful accounts and approximate their fair value given their short-term nature. The normal credit terms extended to customers ranges between 30 and 90 days. Credit terms longer than these may be extended after considering the credit worthiness of the customers and the business requirements. The Company reviews all receivables that exceed terms and establishes an allowance for doubtful accounts based on management’s assessment of the collectability of trade and other receivables. A considerable amount of judgment is required in assessing the amount of allowance. The Company considers the historical level of credit losses, makes judgments about the credit worthiness of each customer based on ongoing credit evaluations and monitors current economic trends that might impact the level of credit losses in the future. As of December 31, 2018 and 2017, allowances for doubtful accounts for trade receivables were $606,835 and $596,196. Bad debt expenses for trade receivables were $185,335 and $494,436 for the years ended December 31, 2018 and 2017. |
Concentrations | (i) Concentrations Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash on deposit with financial institutions and accounts receivable. At times, the Company’s cash in banks is in excess of the FDIC insurance limit. The Company has not experienced any loss as a result of these cash deposits. These cash balances are maintained with two banks. Major Customers For the year ended December 31, 2018, two customers generated 57% and 14%, or 71% in the aggregate, of the Company’s revenue. For the year ended December 31, 2017, three customers generated 32%, 26% and 15%, or 73% in the aggregate, of the Company’s revenue. Two customers accounted for 59% and 14%, or 73% in the aggregate, of gross trade receivables, before accounting for allowance for doubtful accounts, as of December 31, 2018. As of December 31, 2018, the Company had $458,902 and $111,037 in trade receivables, respectively, from these customers. These concentrations makes the Company vulnerable to a near-term severe impact should these relationships be terminated. To limit such risks, the Company performs ongoing credit evaluations of its customers’ financial condition. Major Suppliers For the year ended December 31, 2018, one supplier accounted for 14% of the Company’s purchases. For the year ended December 31, 2017, no suppliers accounted for 10% or more of the Company’s purchases. Two vendors accounted for 14% and 10%, or 24%, in the aggregate, of trade payables as of December 31, 2018. For the year ended December 31, 2017, no vendors accounted for 10% or more of the Company’s trade payables. |
Property, Plant and Equipment | (j) Property, Plant and Equipment Items of property, plant and equipment are measured at cost less accumulated depreciation and accumulated impairment losses. Costs include expenditures that are directly attributable to the acquisition of the asset. Gains and losses on disposal of an item of property, plant and equipment are determined by comparing the proceeds from disposal with the carrying amount of property, plant and equipment and are recognized within “other (income)/expense” in the consolidated statement of operations and comprehensive loss. Depreciation is recognized in the consolidated statements of operations and comprehensive loss on the accelerated basis over the estimated useful lives of the property, plant and equipment. Leased assets are depreciated over the shorter of the lease term or their useful lives. The estimated useful lives for the current and comparative periods are as follows: Useful Life (in years) Plant and equipment 5-12 Furniture and fixtures 5-10 Computer equipment & software 3-5 Shorter of the Leasehold Improvements remaining lease or estimated useful life Depreciation methods, useful lives and residual values are reviewed at each reporting date. |
Intangible Assets | (k) Intangible Assets The Company’s long-lived intangible assets, other than goodwill, are assessed for impairment when events or circumstances indicate there may be an impairment. These assets were initially recorded at their estimated fair value at the time of acquisition and assets not acquired in acquisitions were recorded at historical cost. However, if their estimated fair value is less than the carrying amount, other intangible assets with indefinite life are reduced to their estimated fair value through an impairment charge to the consolidated statements of operations and comprehensive loss. Patents and Trade Secrets The Company has developed or acquired several diagnostic tests that can detect the presence of various substances in a person’s breath, blood, urine and saliva. Propriety protection for the Company’s products, technology and process is important to its competitive position. As of December 31, 2018, the Company has ten patents from the United States Patent Office in effect (9,383,368; 7,896,167; 8,097,171; 8,003,061; 8,425,859; 8,871,521; 8,808,639; D691,056; D691,057 and D691,058). Other patents are in effect in Australia through the Design Registry (348,310; 348,311 and 348,312), European Union Patents 1793906, 2684025, 002216895-0001; 002216895-0002 and 002216895-0003), in Hong Kong (HK11004006) and in Japan (1,515,170; 4,885,134; 4,931,821 5,775,790, and 6023096). Patents are in the national phase of prosecution in many Patent Cooperation Treaty participating countries. Additional proprietary technology consists of numerous different inventions. Management intends to protect all other intellectual property (e.g. copyrights, trademarks and trade secrets) using all legal remedies available to the Company. Patent Costs Costs associated with applying for patents are capitalized as patent costs. Once the patents are approved, the respective costs are amortized over their estimated useful lives (maximum of 17 years) on a straight-line basis and assessed for impairment when necessary. Patent pending costs for patents that are not approved are charged to the consolidated statements of operations and comprehensive loss the year the patent is rejected. In addition, patents may be purchased from third parties. The costs of acquiring the patent are capitalized as patent costs if it represents a future economic benefit to the Company. Once a patent is acquired it is amortized over its remaining useful life and assessed for impairment when necessary. Other Intangible Assets Other intangible assets that are acquired by the Company, which have definite useful lives, are measured at cost less accumulated amortization and accumulated impairment losses. Amortization Amortization is recognized on a straight-line basis over the estimated useful lives of intangible assets, other than goodwill, from the date that they are available for use. The estimated useful lives for the current and comparative periods are as follows: Useful Life (in years) Patents and trademarks 12-17 Customer lists 5 |
Recoverability of Long Lived Assets | (l) Recoverability of Long Lived Assets In accordance with FASB ASC 360-10-35 “Impairment or Disposal of Long-lived Assets”, long-lived assets to be held and used are analyzed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be fully recoverable or that the useful lives of those assets are no longer appropriate. The Company evaluates at each balance sheet date whether events and circumstances have occurred that indicate possible impairment. The Company determines the existence of such impairment by measuring the expected future cash flows (undiscounted and without interest charges) and comparing such amount to the carrying amount of the assets. An impairment loss, if one exists, is then measured as the amount by which the carrying amount of the asset exceeds the discounted estimated future cash flows. Assets to be disposed of are reported at the lower of the carrying amount or fair value of such assets less costs to sell. Asset impairment charges are recorded to reduce the carrying amount of the long-lived asset that will be sold or disposed of to their estimated fair values. Charges for the asset impairment reduce the carrying amount of the long-lived assets to their estimated salvage value in connection with the decision to dispose of such assets. |
Investments | (m) Investments In accordance with FASB ASC 323, the Company recognizes investments in joint ventures based upon the Company’s ability to significantly influence the operational or financial policies of the joint venture. An objective judgment of the level of influence is made at the time of the investment based upon several factors including, but not limited to the following: a) Representation on the Board of Directors b) Participation in policy-making processes c) Material intra-entity transactions d) Interchange of management personnel e) Technological dependencies f) Extent of ownership and the ability to influence decision making based upon the makeup of other owners when the shareholder group is small. The Company follows the equity method for valuating investments in joint ventures when the existence of significant influence over operational and financial policy has been established, as determined by management; otherwise, the Company will valuate these investments using the cost method. Investments recorded using the cost method will be assessed for any decrease in value that has occurred that is other than temporary and the other than temporary decrease in value shall be recognized. As and when circumstances and facts change, the Company will evaluate the Company’s ability to significantly influence operational and financial policy to establish a basis for converting the investment accounted for using the cost method to the equity method of valuation. |
Revenue Recognition | (n) Revenue Recognition In accordance with FASB ASC 605, the Company recognizes revenue when (i) persuasive evidence of a customer or distributor arrangement exists, (ii) a retailer, distributor or wholesaler receives the goods and acceptance occurs, (iii) the price is fixed or determinable, and (iv) the collectability of the revenue is reasonably assured. Subject to these criteria, the Company recognizes revenue from product sales when title passes to the customer based on shipping terms. The Company typically does not accept returns nor offer charge backs or rebates except for certain distributors. Revenue recorded is net of any discount, rebate or sales return. The accrual for estimated sales returns was $57,446 and $0 as of December 31, 2018 and 2017, respectively. In cases where the right of return is granted and the Company does not have historical experience to reasonably estimate the sales returns, the revenue is recognized when the return privilege has substantially expired. The Company may provide for rebates to the distributors under limited circumstances. The Company established an accrual of $23,179 and $126,471, which is a reduction of revenue as of December 31, 2018 and 2017. Accounts receivable will be reduced when the rebates are applied by the customer. The Company recognized $105,247 and $296,164 during the years ended December 31, 2018 and 2017 for rebates, which is included as a reduction of product revenue in the Consolidated Statement of Operations and Comprehensive Loss. License fee revenue is recognized on a straight-line basis over the term of the license agreement. When the Company enters into arrangements that contain more than one deliverable, the Company allocates revenue to the separate elements under the arrangement based on their relative selling prices in accordance with FASB ASC 605-25. |
Income Taxes | (o) Income Taxes The Company follows FASB ASC 740 when accounting for income taxes, which requires an asset and liability approach to financial accounting and reporting for income taxes. Deferred income tax assets and liabilities are computed annually for temporary differences between the financial statements and tax bases of assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense or benefit is the tax payable or refundable for the period plus or minus the change during the period in deferred tax assets and liabilities. |
Shipping and Handling Fees and Costs | (p) Shipping and Handling Fees and Costs The Company charges actual shipping costs plus a handling fee to customers, which amounted to $50,518 and $59,985 for the years ended December 31, 2018 and 2017. These fees are classified as part of product revenue in the Consolidated Statement of Operations and Comprehensive Loss. Shipping and other related delivery costs, including those for incoming raw materials are classified as part of the cost of net revenue, which amounted to $93,558 and $136,145 for the years ended December 31, 2018 and 2017, respectively. |
Research and Development Costs | (q) Research and Development Costs In accordance with FASB ASC 730, research and development costs are expensed when incurred. |
Stock-based Payments | (r) Stock-based Payments The Company accounts for stock-based compensation under the provisions of FASB ASC 718, “Compensation—Stock Compensation”, which requires the measurement and recognition of compensation expense for all stock-based awards made to employees and directors based on estimated fair values on the grant date. The Company estimates the fair value of stock-based awards on the date of grant using the Black-Scholes model. The value of the portion of the award that is scheduled to vest is recognized as expense over shorter of the period over which services are to be received or the vesting period. The Company accounts for stock-based compensation awards to non-employees in accordance with FASB ASC 505-50, “Equity-Based Payments to Non-Employees”. Under FASB ASC 505-50, the Company determines the fair value of the stock warrants or stock-based compensation awards granted as either the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measurable. The Company estimates the fair value of stock-based awards to non-employees on the date of grant using the Black-Scholes model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the period which services are to be received. At the end of each financial reporting period, prior to vesting or prior to completion of services, the fair value of equity based payments will be re-measured and the non-cash expense recognized during the period will be adjusted accordingly. Since the fair value of equity based payments granted to non-employees is subject to change in the future, the amount of the future expense will include fair value re-measurement until the equity based payments are fully vested or the service is completed. The Company has elected to account for forfeiture of stock based awards as they occur. |
Basic and Diluted Earnings Per Share of Common Stock | (s) Basic and Diluted Earnings per Share of Common Stock Basic earnings per common share are based on the weighted average number of shares outstanding during the periods presented. Diluted earnings per share are computed using the weighted average number of common shares plus dilutive common share equivalents outstanding during the period. Potential common shares that would have the effect of increasing diluted earnings per share are considered anti-dilutive, i.e. the exercise prices of the outstanding stock options were greater than the market price of the Common Stock. The calculation of basic and diluted loss per share for the years ended December 31, 2018 and 2017 was based on the loss attributable to common shareholders of $10,849,034 and $7,366,310, respectively. The basic and diluted weighted average number of common shares outstanding for the years ended December 31, 2018 and 2017 was 10,973,830 and 1,171,683, respectively. Diluted net loss per share is computed using the weighted average number of common and dilutive potential common shares outstanding during the period. The following securities are excluded from the calculation of weighted average dilutive common shares because their inclusion would have been anti-dilutive: For the Years Ended December 31, 2018 2017 Incentive and Award Stock Options 10,502 31,875 Unvested Restricted Shares of Common Stock - 1,146 Warrants 2,110,737 6,186,471 Total potentially dilutive shares 2,121,239 6,219,492 |
Recently Issued Accounting Pronouncements | (t) Recently Issued Accounting Pronouncements Recently Issued Accounting Pronouncements Adopted As the Company is an emerging growth company, it has elected to adopt recently issued accounting pronouncements based on effective dates applicable to other than public business entities. On March 30, 2016, the FASB issued ASU No. 2016-09, “Compensation – Stock Compensation (Topic 718)”. This update requires that all excess tax benefits and tax deficiencies arising from share-based payment awards should be recognized as income tax expense or benefit on the income statement. The amendment also states that excess tax benefits should be classified along with other income tax cash flows as an operating activity. In addition, an entity can make an entity-wide accounting policy election to either estimate the number of awards expected to vest or account for forfeitures as they occur. The provisions of this update are effective for annual and interim periods beginning after December 15, 2017. The Company adopted this standard effective January 1, 2018. The adoption did not have a material effect on the Company’s consolidated financial statements. In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230), Restricted Cash. The amendments in this Update require that a statement of cash flows explains the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of period and end-of-period total amounts shown on the statement of cash flows. The amendments in this Update do not provide a definition of restricted cash or restricted cash equivalents. The amendments in this Update are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2018, and interim periods within fiscal years beginning after December 15, 2019. Early adoption is permitted. The Company adopted this as of January 1, 2018 (See Note 2(f)). Recently Issued Accounting Pronouncements Not Adopted In May 2014 and April 2016, the FASB issued ASU No. 2014-09 and ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606). The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In August 2015, FASB issued ASU 2015-14 which deferred the effective date of Update 2014-09 to annual reporting periods beginning after December 15, 2018 for entities other than public business entities, and to annual reporting periods beginning after December 15, 2017, including interim reporting periods within that reporting period for public business entities. Early application is permitted as of annual reporting periods beginning after December 15, 2016 including interim reporting periods within that reporting period. The Company is currently evaluating the effect of the amendments, but it does not anticipate a material impact of its financial statements. The Company expects to use the modified retrospective adoption method and will adopt this Update as of January 1, 2019. In February 2016, the FASB issued ASU 2016-02—Leases (Topic 842) (“ASU-2016-02”), which requires an entity to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. ASU 2016-02 offers specific accounting guidance for a lessee, a lessor, and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. ASU 2016-02 is effective for annual reporting periods beginning after December 15, 2019, including interim periods within that reporting period, and requires a modified retrospective adoption, with early adoption permitted. The Company is currently evaluating the effect this guidance will have on its consolidated financial statements and related disclosure, and anticipates the guidance to result in increases in its assets and liabilities as most of its operating lease commitments will be subject to the new standard and recognized as right-of-use assets and lease liabilities. In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The guidance is effective for public business entities, certain not-for-profit entities, and certain employee benefit plans for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. For all other entities, ASU 2018-07 is effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company is evaluating the impact of adopting this pronouncement. In July 2018, the FASB issued ASU No. 2018-09, Codification Improvements, to makes changes to a variety of topics to clarify, correct errors in, or make minor improvements to the Accounting Standards Codification. Certain items of the amendments in ASU 2018-09 will be effective for the Company in annual periods beginning after December 15, 2018. The Company is currently evaluating the effects the adoption of ASU 2018-09 will have on the consolidated financial statements. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Marketable Securities | This includes basing value on yields currently available on comparable securities of issuers with similar credit ratings. Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) Quoted Prices for Similar Assets or Liabilities in Active Markets (Level 2) Significant Unobservable Inputs (Level 3) Marketable securities at December 31, 2018 $ - $ 5,272,998 $ - Marketable securities at December 31, 2017 $ - $ 5,011,607 $ - |
Schedule of Estimated Useful Life of Property Plant and Equipment | The estimated useful lives for the current and comparative periods are as follows: Useful Life (in years) Plant and equipment 5-12 Furniture and fixtures 5-10 Computer equipment & software 3-5 Shorter of the Leasehold Improvements remaining lease or estimated useful life |
Schedule of Estimated Useful Life of Other Intangible Assets | The estimated useful lives for the current and comparative periods are as follows: Useful Life (in years) Patents and trademarks 12-17 Customer lists 5 |
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | The following securities are excluded from the calculation of weighted average dilutive common shares because their inclusion would have been anti-dilutive: For the Years Ended December 31, 2018 2017 Incentive and Award Stock Options 10,502 31,875 Unvested Restricted Shares of Common Stock - 1,146 Warrants 2,110,737 6,186,471 Total potentially dilutive shares 2,121,239 6,219,492 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consist of the following: December 31, 2018 December 31, 2017 Raw Materials $ 542,761 $ 458,441 Sub-Assemblies 711,181 886,274 Finished Goods 635,565 815,505 Reserve for Obsolescence (1,304,240 ) (1,212,608 ) $ 585,267 $ 947,612 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property, plant and equipment consists of the following: December 31, 2018 2017 Computer Equipment $ 17,514 $ 114,771 Computer Software 7,806 40,681 Office Equipment 39,959 39,959 Furniture & Fixtures 38,357 38,356 Machinery & Equipment 1,153,830 1,138,134 Molds & Dies 645,272 868,570 Leasehold Improvements 249,960 222,593 2,152,698 2,463,064 Less Accumulated Depreciation 2,069,242 2,227,951 $ 83,456 $ 235,113 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Finite-Lived Intangible Assets | Intangible assets as of December 31, 2018 and 2017 are as follows: December 31, 2018 Cost or Accumulated Net Deemed Amortization Book Cost and Impairment Value Patents & Trademarks $ 2,626,996 $ (2,383,585 ) $ 243,411 Distributors & Customer Relationships 1,270,639 (1,270,639 ) - Total $ 3,897,635 $ (3,654,224 ) $ 243,411 December 31, 2017 Cost or Accumulated Net Deemed Amortization Book Cost and Impairment Value Patents & Trademarks $ 2,626,996 $ (1,496,329 ) $ 1,130,667 Distributors & Customer Relationships 1,270,639 (1,270,639 ) - Total $ 3,897,635 $ (2,766,968 ) $ 1,130,667 |
Schedule of Estimated Aggregate Amortization Expense of Fiscal Years | The following is an annual schedule of approximate future amortization of the Company’s intangible assets: Period Amount 2019 41,336 2020 41,336 2021 41,336 2022 41,336 2023 34,696 Thereafter 43,371 Total $ 243,411 |
Trade and Other Payables (Table
Trade and Other Payables (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of Trade and Other Payables | Trade and other payables consists of the following: December 31, 2018 2017 Trade Payables $ 686,578 $ 988,772 Accrued Expenses 1,227,172 736,515 Deferred Compensation 59,750 59,750 $ 1,973,500 $ 1,785,037 |
Share-based Payments (Tables)
Share-based Payments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock Options Activity | The following table summarizes the option activities for the year ended December 31, 2018: Weighted Average Weighted Weighted Remaining Number Average Average Contractual Aggregate of Exercise Grant Date Term Intrinsic Shares Price Fair Value (years) Value Balance at December 31, 2017 31,878 $ 33.98 $ 20.49 2.02 $ - Granted - - - - - Exercised - - - - - Forfeited (21,376 ) 35.74 22.00 0.82 - Canceled/Expired - - - - - Balance at December 31, 2018 10,502 $ 30.41 $ 17.42 1.43 $ - Exercisable as of December 31, 2018 10,502 $ 30.41 $ 17.42 1.43 $ - |
Summary of Warrant Activity | The table below summarizes the warrant activity for the year ended December 31, 2018: Average Weighted Remaining Number Average Contractual Aggregate of Exercise Term Intrinsic Warrants Price (years) Value Balance at December 31, 2017 6,186,471 $ 1.79 4.95 $ - Granted 694,446 3.76 - Exercised (4,770,180 ) 1.50 - Forfeited - - - Canceled/Expired - - - Balance at December 31, 2018 2,110,737 $ 3.10 4.21 $ - Exercisable as of December 31, 2018 2,110,737 $ 3.10 4.21 $ - |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income Tax (Benefit)/Provision | The Company’s income tax (benefit)/provision is as follows: Years Ended December 31, 2018 2017 Current $ - $ - Deferred (2,941,000 ) $ (6,003,000 ) Change in Valuation Allowance 2,941,000 $ 6,003,000 Income Tax Benefit $ - $ - |
Schedule of Reconciliation of Income Taxes using Statutory U.S. Income Tax Rate and Benefit from Income Taxes | The reconciliation of income taxes using the statutory U.S. income tax rate and the benefit from income taxes for the years ended December 31, 2018 and 2017 are as follows: Years Ended December 31, 2018 2017 Statutory U.S. Federal Income Tax Rate (21.0 )% (35.0 )% New Jersey State income taxes, net of U.S. Federal tax effect (5.1 )% (6.0 )% Disallowed research and development expenditures 0.1 % - % True-up for prior year deferred tax assets (0.9 )% - % Research and development tax credit (0.2 )% - % Tax rate change - % 122.0 % Change in Valuation Allowance 27.1 % (81.0 )% Net 0.0 % 0.0 % |
Schedule of Deferred Tax Assets and Related Valuation Allowances | The principal components of the deferred tax assets and related valuation allowances as of December 31, 2018 and 2017 are as follows: Years Ended December 31, 2018 2017 Reserves and other $ 523,000 $ 718,000 Net operating loss carry-forwards 18,417,000 15,762,000 Research and development tax credit 481,000 - Valuation Allowance (19,421,000 ) (16,480,000 ) Net $ - $ - |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Lease Commitments | The schedule of lease commitments is as follows: Thorofare Ramsey Pitman Equipment Lease Lease Lease Lease Total Next 12 Months $ 132,000 $ 4,330 $ 39,650 $ 5,130 $ 181,110 |
Revenue Information (Tables)
Revenue Information (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Segment Reporting [Abstract] | |
Schedule of Revenue by Product Lines | Revenue by product lines was as follows: Years Ended December 31, Product Line 2018 2017 MicroParticle Catalyzed Biosensor (“MPC”) $ 123,941 $ 381,228 Particle ImmunoFiltration Assay (“PIFA”) 1,422,361 2,232,684 Rapid Enzymatic Assay (“REA”) 68,750 133,848 Other 50,518 556,952 Product Revenue Total 1,665,570 3,304,712 License Fees - 50,000 Total Revenue $ 1,665,570 $ 3,354,712 |
Schedule of Revenue by Geographic Area Determined Based On Location of Customers | The total revenue by geographic area determined based on the location of the customers was as follows: Years Ended December 31, Geographic Region 2018 2017 United States $ 1,576,765 $ 2,679,549 People’s Republic of China - 502,131 Rest of World 88,805 173,032 Total Revenue $ 1,665,570 $ 3,354,712 |
Significant Accounting Polici_4
Significant Accounting Policies (Details Narrative) | Nov. 08, 2018 | Dec. 31, 2018USD ($)Breathalyzersshares | Dec. 31, 2017USD ($)Breathalyzersshares |
Reverse stock split | On November 8, 2018, the Company effectuated a reverse stock split of its shares of common stock whereby every eight (8) pre-split shares of common stock were exchanged for one (1) post-split share of the Company's common stock ("Reverse Stock Split"). | reverse stock split of its Common Stock at a ratio of eight-for-one (8-for-1). | |
Restricted cash | $ 500,000 | ||
Maturities of securities | less than one year | ||
Unrealized loss on securities | $ 25,913 | 0 | |
Marketable securities, gain | 15,178 | 3,375 | |
Allowances for doubtful accounts for trade receivables | 606,835 | 596,196 | |
Bad debt expenses | 185,335 | 494,436 | |
Trade receivables | 176,326 | 964,671 | |
Accrual for estimated sales returns | 57,446 | 0 | |
Accrued liabilities | 23,179 | 126,471 | |
Deferred revenue, recognized | 105,247 | 296,164 | |
Shipping, handling and transportation costs | 1,538,285 | 2,406,132 | |
Cost of net revenue | 93,558 | 136,145 | |
Net loss attributable to common shareholders | $ 10,849,034 | $ 7,366,310 | |
Weighted average basic and diluted common shares outstanding | shares | 10,973,830 | 1,171,683 | |
Shipping and Handling [Member] | |||
Shipping, handling and transportation costs | $ 50,518 | $ 59,985 | |
One Suppliers [Member] | |||
Concentration risk percentage | 14.00% | ||
No Supplier [Member] | |||
Concentration risk percentage | 10.00% | ||
No Vendor [Member] | |||
Concentration risk percentage | 10.00% | ||
Sales Revenue, Net [Member] | |||
Concentration risk percentage | 71.00% | 73.00% | |
Concentration risk, number of customer | Breathalyzers | 2 | 3 | |
Sales Revenue, Net [Member] | Customer One [Member] | |||
Concentration risk percentage | 57.00% | 32.00% | |
Sales Revenue, Net [Member] | Customer Two [Member] | |||
Concentration risk percentage | 14.00% | 26.00% | |
Sales Revenue, Net [Member] | Customer Three [Member] | |||
Concentration risk percentage | 15.00% | ||
Trade Receivable [Member] | |||
Concentration risk percentage | 73.00% | ||
Concentration risk, number of customer | Breathalyzers | 2 | ||
Trade receivables | $ 458,902 | $ 111,037 | |
Trade Receivable [Member] | Customer One [Member] | |||
Concentration risk percentage | 59.00% | ||
Trade Receivable [Member] | Customer Two [Member] | |||
Concentration risk percentage | 14.00% | ||
Trade Payables [Member] | |||
Concentration risk percentage | 24.00% | ||
Trade Payables [Member] | Vendor One [Member] | |||
Concentration risk percentage | 14.00% | ||
Trade Payables [Member] | Vendor Two [Member] | |||
Concentration risk percentage | 10.00% | ||
Maximum [Member] | |||
Normal credit terms extended to customers | 90 days | ||
Maximum [Member] | Patents [Member] | |||
Amortized over estimated useful life | 17 years | ||
Minimum [Member] | |||
Normal credit terms extended to customers | 30 days |
Significant Accounting Polici_5
Significant Accounting Policies - Schedule of Marketable Securities (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Level 1 [Member] | ||
Marketable securities | ||
Level 2 [Member] | ||
Marketable securities | 5,272,998 | 5,011,607 |
Level 3 [Member] | ||
Marketable securities |
Significant Accounting Polici_6
Significant Accounting Policies - Schedule of Estimated Useful Life of Property Plant and Equipment (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Plant and Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Plant and Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 12 years |
Furniture & Fixtures [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Furniture & Fixtures [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 10 years |
Computer Equipment & Software [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 3 years |
Computer Equipment & Software [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Leasehold Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life Description | Shorter of the remaining lease or estimated useful life |
Significant Accounting Polici_7
Significant Accounting Policies - Schedule of Estimated Useful Life of Other Intangible Assets (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Patents and Trademarks [Member] | Minimum [Member] | |
Amortization of estimated useful life | 12 years |
Patents and Trademarks [Member] | Maximum [Member] | |
Amortization of estimated useful life | 17 years |
Customer Lists [Member] | |
Amortization of estimated useful life | 5 years |
Significant Accounting Polici_8
Significant Accounting Policies - Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Total potentially dilutive shares | 2,121,239 | 6,219,492 |
Incentive and Award Stock Options [Member] | ||
Total potentially dilutive shares | 10,502 | 31,875 |
Unvested Restricted Shares of Common Stock [Member] | ||
Total potentially dilutive shares | 1,146 | |
Warrants [Member] | ||
Total potentially dilutive shares | 2,110,737 | 6,186,471 |
Recent Developments and Manag_2
Recent Developments and Management's Plans (Details Narrative) - USD ($) | Nov. 02, 2018 | Oct. 09, 2018 | Oct. 05, 2018 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Oct. 05, 2016 | Jan. 09, 2015 |
Recent events description | By way of a letter dated November 28, 2017, the Listing Qualifications Department of NASDAQ advised the Company that it did not comply with NASDAQ Listing Rule 5550(a)(2) for continued listing, because the Company's Common Stock did not meet NASDAQ's minimum $1.00 bid price requirement (the "Price Requirement"). The Company informed Nasdaq that the Company is fully committed to regain compliance with the Price Requirement as quickly as possible and, therefore, proposed to institute a reverse stock split. NASDAQ approved of the Company's proposal of a reverse stock split and granted the Company until November 26, 2018, for the Company to be in compliance with the Price Requirement. The Company's stock price did remain priced above $1.00 November 22, 2018, it is expected that Nasdaq, thereafter notified the Company that it had regained compliance with the NASDAQ Price Requirements. | |||||||
Number of shares granted | ||||||||
Settelment amount payment | $ 930,000 | $ 1,505,000 | ||||||
Proceeds from public offering | 9,478,897 | |||||||
Additional expenses from exercise of warrants | $ 7,155,200 | 981,948 | ||||||
Proceeds from issuance of common stock | $ 2,000,000 | $ 1,950,000 | $ 5,803,897 | |||||
Common stock shares sold during period | 694,446 | |||||||
Exercise price of warrant issued to purchase of common stock | $ 3.76 | $ 3.76 | ||||||
March 22, 2019 [Member] | ||||||||
Cash and marketable securities | $ 4,700,000 | |||||||
Restricted cash | 500,000 | |||||||
Working capital | $ 4,600,000 | |||||||
Mr. Yeaton [Member] | ||||||||
Stock issued for compensation | 3,750 | |||||||
Stock issued upon termination | 25,000 | |||||||
2013 Plan [Member] | ||||||||
Number of shares granted | 50,000 | |||||||
2013 Plan [Member] | Minimum [Member] | ||||||||
Number of shares available under stock plan | 100,000 | 50,000 | ||||||
2013 Plan [Member] | Maximum [Member] | ||||||||
Number of shares available under stock plan | 103,750 | 100,000 |
Inventories (Details Narrative)
Inventories (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cost of goods sold for obsolete inventory | $ 453,761 | $ 1,208,522 |
Inventory reserved | 1,304,240 | 1,212,608 |
Established inventory reserves | $ 1,182,400 | |
BreathScan OxiChek [Member] | ||
Cost of goods sold for obsolete inventory | 187,399 | |
Inventory reserved | 279,031 | |
Increase in reserve for obsolescence | $ 91,632 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Raw Materials | $ 542,761 | $ 458,441 |
Sub-Assemblies | 711,181 | 886,274 |
Finished Goods | 635,565 | 815,505 |
Reserve for Obsolescence | (1,304,240) | (1,212,608) |
Total Inventory, Net | $ 585,267 | $ 947,612 |
Property, Plant and Equipment_2
Property, Plant and Equipment (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 63,378 | $ 78,786 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment | $ 2,152,698 | $ 2,463,064 |
Accumulated Depreciation | 2,069,242 | 2,227,951 |
Property, Plant and Equipment, Net | 83,456 | 235,113 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment | 17,514 | 114,771 |
Computer Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment | 7,806 | 40,681 |
Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment | 39,959 | 39,959 |
Furniture & Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment | 38,357 | 38,356 |
Machinery & Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment | 1,153,830 | 1,138,134 |
Molds & Dies [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment | 645,272 | 868,570 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment | $ 249,960 | $ 222,593 |
Intangible Assets (Details Narr
Intangible Assets (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Intangible assets | $ 243,411 | $ 1,130,667 |
Accumulated amortization | (3,654,224) | (2,766,968) |
Impairment of intangible asset | 716,148 | |
Amortization expense | 171,108 | $ 171,108 |
Patents, Trademarks and Customer Lists [Member] | ||
Accumulated amortization | 3,654,224 | |
Impairment of intangible asset | $ 3,897,635 |
Intangible Assets - Schedule o
Intangible Assets - Schedule of Finite-Lived Intangible Assets (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost or Deemed Cost | $ 3,897,635 | $ 3,897,635 |
Accumulated Amortization | (3,654,224) | (2,766,968) |
Net Book Value, Beginning Balance | 243,411 | 1,130,667 |
Patents & Trademarks [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost or Deemed Cost | 2,626,996 | 2,626,996 |
Accumulated Amortization | (2,383,585) | (1,496,329) |
Net Book Value, Beginning Balance | 243,411 | 1,130,667 |
Distributor & Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost or Deemed Cost | 1,270,639 | 1,270,639 |
Accumulated Amortization | (1,270,639) | (1,270,639) |
Net Book Value, Beginning Balance |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Estimated Aggregate Amortization Expense of Fiscal Years (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2019 | $ 41,336 | |
2020 | 41,336 | |
2021 | 41,336 | |
2022 | 41,336 | |
2023 | 34,696 | |
Thereafter | 43,371 | |
Total | $ 243,411 | $ 1,130,667 |
Trade and Other Payables - Sche
Trade and Other Payables - Schedule of Trade and Other Payables (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Trade Payables | $ 686,578 | $ 988,772 |
Accrued Expenses | 1,227,172 | 736,515 |
Deferred Compensation | 59,750 | 59,750 |
Trade and Other Payables, Total | $ 1,973,500 | $ 1,785,037 |
Share-based Payments (Details N
Share-based Payments (Details Narrative) - USD ($) | Dec. 07, 2018 | Nov. 02, 2018 | Aug. 07, 2017 | Jan. 23, 2014 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2016 | Jan. 09, 2015 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of stock option issued | ||||||||
Number of common stock issued, shares | 694,446 | |||||||
Closing stock price per share | $ 1.13 | |||||||
Stock options expenses | $ 6,931 | $ 17,274 | ||||||
Aggregate intrinsic value exercise price of options | $ 1.13 | |||||||
Board of Directors [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of shares authorized during period | 103,750 | |||||||
Amended and Restated 2013 Incentive Stock And Award Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of shares authorized during period | 100,000 | |||||||
Amended Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of available for grants | 25,722 | |||||||
Amended Plan [Member] | Restricted Stock [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of stock option to purchase shares of common stock | 78,028 | |||||||
2017 Equity Incentive Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of available for grants | 132,718 | |||||||
Number of grants totaling shares of restricted common stock | 36,032 | |||||||
2018 Equity Incentive Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of stock option issued | 1,875,000 | |||||||
Number of available for grants | 1,875,000 | |||||||
Number of common stock issued, shares | 10,625 | |||||||
Maximum [Member] | 2013 Stock Incentive Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of stock option issued | 50,000 | |||||||
Maximum [Member] | 2017 Equity Incentive Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of stock option issued | 168,750 |
Share-based Payments - Summary
Share-based Payments - Summary of Stock Options Activity (Details) | 12 Months Ended |
Dec. 31, 2018USD ($)$ / sharesshares | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Number of Shares, Beginning Balance | shares | 31,878 |
Number of Shares, Granted | shares | |
Number of Shares, Exercised | shares | |
Number of Shares, Forfeited | shares | (21,373) |
Number of Shares, Cancelled/Expired | shares | |
Number of Shares, Ending Balance | shares | 10,502 |
Number of Shares, Exercisable | shares | 10,502 |
Weighted Average Exercise Price, Beginning Balance | $ 33.98 |
Weighted Average Exercise Price, Granted | |
Weighted Average Exercise Price, Exercised | |
Weighted Average Exercise Price, Forfeited | 35.74 |
Weighted Average Exercise Price, Cancelled/Expired | |
Weighted Average Exercise Price, Ending Balance | 30.41 |
Weighted Average Exercise Price, Exercisable | 30.41 |
Weighted Average Grant Date Fair Value, Beginning | 20.49 |
Weighted Average Grant Date Fair Value, Granted | |
Weighted Average Grant Date Fair Value, Exercised | |
Weighted Average Grant Date Fair Value, Forfeited | 22 |
Weighted Average Grant Date Fair Value, Cancelled/Expired | |
Weighted Average Grant Date Fair Value, Ending | 17.42 |
Weighted Average Grant Date Fair Value, Exercisable | $ 17.42 |
Weighted Average Remaining Contractual Term (Years), Beginning | 2 years 7 days |
Weighted Average Remaining Contractual Term (Years), Granted | 0 years |
Weighted Average Remaining Contractual Term (Years), Exercised | 0 years |
Weighted Average Remaining Contractual Term (Years), Forfeited | 9 months 25 days |
Weighted Average Remaining Contractual Term (Years), Cancelled/Expired | 0 years |
Weighted Average Remaining Contractual Term (Years), Ending | 1 year 5 months 5 days |
Weighted Average Remaining Contractual Term (Years), Exercisable | 1 year 5 months 5 days |
Aggregate Intrinsic Value, Beginning Balance | $ | |
Aggregate Intrinsic Value, Ending Balance | $ | |
Aggregate Intrinsic Value, Exercisable | $ |
Share-based Payments - Summar_2
Share-based Payments - Summary of Warrant Activity (Details) - Warrants [Member] | 12 Months Ended |
Dec. 31, 2018USD ($)$ / sharesshares | |
Number of Warrants, Beginning Balance | shares | 6,186,471 |
Number of Warrants, Granted | shares | 694,446 |
Number of Warrants, Exercised | shares | (4,770,180) |
Number of Warrants, Forfeited | shares | |
Number of Warrants, Cancelled/Expired | shares | |
Number of Warrants, Ending Balance | shares | 2,110,737 |
Number of Warrants, Exercisable | shares | 2,110,737 |
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 1.79 |
Weighted Average Exercise Price, Granted | $ / shares | 3.76 |
Weighted Average Exercise Price, Exercised | $ / shares | 1.50 |
Weighted Average Exercise Price, Forfeited | $ / shares | |
Weighted Average Exercise Price, Cancelled/Expired | $ / shares | |
Weighted Average Exercise Price, Ending Balance | $ / shares | 3.10 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 3.10 |
Weighted Average Remaining Contractual Term (years), Beginning | 4 years 11 months 12 days |
Weighted Average Remaining Contractual Term (years), Ending | 4 years 2 months 16 days |
Weighted Average Remaining Contractual Term (years), Exercisable | 4 years 2 months 16 days |
Aggregate Intrinsic Value, Beginning | $ | |
Aggregate Intrinsic Value, Ending | $ | |
Aggregate Intrinsic Value, Exercisable | $ |
Equity (Details Narrative)
Equity (Details Narrative) - USD ($) | Nov. 08, 2018 | Nov. 02, 2018 | Dec. 21, 2017 | Oct. 17, 2017 | Oct. 12, 2017 | Apr. 11, 2017 | Mar. 30, 2017 | Jan. 13, 2017 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Number of common stock issued, shares | 694,446 | ||||||||||
Number of common stock issued | $ 1,652,994 | ||||||||||
Warrant exercise price | $ 3.76 | $ 3.76 | |||||||||
Share based compensation expenses | $ 5,455 | ||||||||||
Restricted common shares issued, value | $ 12,545 | $ 12,545 | |||||||||
Preferred stock, par value | |||||||||||
Common stock outstanding percentage | 4.99% | ||||||||||
Reverse stock split | On November 8, 2018, the Company effectuated a reverse stock split of its shares of common stock whereby every eight (8) pre-split shares of common stock were exchanged for one (1) post-split share of the Company's common stock ("Reverse Stock Split"). | reverse stock split of its Common Stock at a ratio of eight-for-one (8-for-1). | |||||||||
Common stock shares outstanding | 12,482,708 | 5,534,692 | |||||||||
Series B Preferred Stock [Member] | |||||||||||
Conversion of stock | 1,755 | ||||||||||
Preferred stock, par value | |||||||||||
Conversion of stock, shares issued | 1,464,930 | ||||||||||
Current Warrant [Member] | |||||||||||
Warrant exercise price | $ 8 | ||||||||||
New Warrant [Member] | |||||||||||
Number of warrant issued during period | 90,525 | ||||||||||
Warrant exercise price | $ 10.08 | ||||||||||
Warrant term | 5 years | ||||||||||
Fair value of warrants | $ 671,546 | ||||||||||
Dividend yield | 0.00% | ||||||||||
Expected volatility | 97.16% | ||||||||||
Risk free interest rate | 1.95% | ||||||||||
Expected life | 5 years | ||||||||||
Warrants [Member] | |||||||||||
Fair value of warrants | $ 93,386 | ||||||||||
Dividend yield | 0.00% | ||||||||||
Expected volatility | 97.16% | ||||||||||
Risk free interest rate | 1.95% | ||||||||||
Expected life | 4 years 5 months 20 days | ||||||||||
Warrants [Member] | Minimum [Member] | |||||||||||
Warrant exercise price | $ 15.68 | ||||||||||
Warrants [Member] | Maximum [Member] | |||||||||||
Warrant exercise price | $ 8 | ||||||||||
Series B Convertible Preferred Shares [Member] | |||||||||||
Number of common stock issued, shares | 3,675 | ||||||||||
Warrant Exercise Agreement [Member] | |||||||||||
Number of warrant issued during period | 90,525 | ||||||||||
Warrant exercise price | $ 15.68 | ||||||||||
Proceeds from issuance of warrants | $ 680,748 | ||||||||||
Other extraordinary expenses | 764,932 | ||||||||||
Proceeds from net of solicitation fee | $ 43,452 | ||||||||||
Purchase Agreement [Member] | |||||||||||
Number of common stock shares sold | 694,446 | ||||||||||
Proceeeds from issuance of offering, net of offering costs | $ 1,950,000 | ||||||||||
Payments to offering costs | $ 50,000 | ||||||||||
Purchase Agreement [Member] | Warrants [Member] | |||||||||||
Number of warrant issued during period | 694,446 | ||||||||||
Warrant exercise price | $ 2.88 | ||||||||||
Mr. Yeaton [Member] | Employment Agreement [Member] | |||||||||||
Number of common stock issued | $ 7,500 | ||||||||||
Fair value of shares based on share price on date of grant | 16,702 | ||||||||||
Former Executive Officer [Member] | |||||||||||
Number of common stock issued | 3,125 | ||||||||||
Fair value of shares based on share price on date of grant | $ 11,000 | ||||||||||
Restricted Stock [Member] | |||||||||||
Shares issued, price per share | $ 7.04 | ||||||||||
Expenses related to the grants | $ 259,694 | ||||||||||
Restricted Stock [Member] | Key Employees and Officers [Member] | |||||||||||
Number of common stock issued, shares | 36,888 | ||||||||||
Restricted Stock [Member] | Consultant [Member] | |||||||||||
Number of shares issued for services | 1,250 | ||||||||||
Fair value of shares based on share price on date of grant | $ 18,000 | ||||||||||
Initial Public Offering [Member] | |||||||||||
Number of common stock issued, shares | 223,688 | ||||||||||
Number of common stock issued | $ 1,652,994 | ||||||||||
Number of warrant issued during period | 111,844 | ||||||||||
Warrant exercise price | $ 12 | ||||||||||
Warrant term | 5 years | ||||||||||
Private Placement [Member] | |||||||||||
Number of warrant issued during period | 99,578 | ||||||||||
Warrant exercise price | $ 15.68 | ||||||||||
Warrant term | 5 years | ||||||||||
Unregistered shares of common stock | 181,050 | ||||||||||
Proceeds from unregistered shares | $ 1,760,317 | ||||||||||
Public Offering [Member] | |||||||||||
Number of common stock issued, shares | 2,691,962 | ||||||||||
Number of common stock issued | $ 6,065,586 | ||||||||||
Number of warrant issued during period | 5,750,000 | ||||||||||
Warrant exercise price | $ 1.50 | ||||||||||
Public Offering [Member] | Series B Preferred Stock [Member] | |||||||||||
Warrant exercise price | $ 1.50 | ||||||||||
Conversion of stock | 1,920 | ||||||||||
Preferred stock, par value | |||||||||||
Conversion of stock, shares issued | 1,602,658 | ||||||||||
Public Offering [Member] | Warrant Holders [Member] | |||||||||||
Number of warrant issued during period | 4,778,015 | 25,101 | |||||||||
Warrant exercise price | $ 1.50 | $ 12 | |||||||||
Proceeds from issuance of warrants | $ 7,155,200 | $ 301,200 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Statutory corporate tax rate | 0.00% | 0.00% |
Valuation allowance for deferred tax assets | $ 21,894,000 | $ 16,480,000 |
Change in valuation allowance | 2,941,000 | 6,003,000 |
Unrecognized tax benefits | ||
Interest or penalties on unrecognized tax benefits | ||
Uncertain tax positions, accrued | ||
Tax Cuts and Jobs Act [Member] | ||
Income tax description | The Tax Cuts and Jobs Act was enacted, which reduced the U.S. statutory corporate tax rate to 21% for tax years beginning in 2018. This change resulted in a re-measurement of the federal portion of the Company's deferred tax assets and the valuation allowance as of December 31, 2017 from 35% to the new 21% tax rate. | |
Statutory corporate tax rate | 21.00% | |
Federal [Member] | ||
Net operating loss carry forwards | $ 80,500,000 | 69,001,000 |
Operating loss carryforwards expiration date | Dec. 31, 2038 | |
New Jersey State [Member] | ||
Net operating loss carry forwards | $ 29,700,000 | $ 19,392,000 |
Operating loss carryforwards expiration date | Dec. 31, 2025 |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax Benefit (Provision) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Current | ||
Deferred | (2,941,000) | (6,003,000) |
Change in Valuation Allowance | 2,941,000 | 6,003,000 |
Income Tax Benefit |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Income Taxes using Statutory U.S. Income Tax Rate and Benefit from Income Taxes (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Statutory U.S. Federal Income Tax Rate | (21.00%) | (35.00%) |
New Jersey State income taxes, net of U.S. Federal tax effect | (5.10%) | (6.00%) |
Disallowed research and development expenditures | 0.10% | 0.00% |
True-up for prior year deferred tax assets | (0.90%) | 0.00% |
Research and development tax credit | (0.20%) | 0.00% |
Tax rate change | 0.00% | 122.00% |
Change in Valuation Allowance | 27.10% | (81.00%) |
Net | 0.00% | 0.00% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Related Valuation Allowances (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Abstract] | ||
Reserves and other | $ 523,000 | $ 718,000 |
Net operating loss carry-forwards | 18,417,000 | 15,762,000 |
Research and development tax credit | 481,000 | |
Valuation Allowance | (19,421,000) | (16,480,000) |
Net |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) - USD ($) | Nov. 15, 2018 | Oct. 09, 2018 | Sep. 29, 2014 | Jan. 07, 2013 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 24, 2014 |
Royalty expenses | $ 59,584 | $ 202,126 | |||||
Settlement amount payment | $ 930,000 | 1,505,000 | |||||
ChubeWorkx [Member] | |||||||
Royalty expenses | 9,083 | ||||||
Thorofare Lease [Member] | |||||||
Operating lease with annual rentals includng common area maintenance | 132,000 | ||||||
Lease agreement, extended term | 7 years | ||||||
Lease agreement, expiration date | Dec. 31, 2019 | ||||||
Rent expense | 164,996 | 161,807 | |||||
Ramsey Lease [Member] | |||||||
Operating lease with annual rentals includng common area maintenance | 25,980 | ||||||
Rent expense | $ 25,980 | 25,980 | |||||
Lease, term of agreement | 24 months | ||||||
Lease agreement, term description | The lease took effect on June 1, 2017 and runs through May 31, 2019. | ||||||
Security deposit | $ 4,330 | ||||||
Pitman Lease [Member] | |||||||
Operating lease with annual rentals includng common area maintenance | 39,650 | ||||||
Rent expense | $ 6,156 | $ 40,245 | $ 16,670 | ||||
Lease, term of agreement | 29 months | 60 months | |||||
Lease agreement, term description | The lease took effect on August 1, 2017 and runs through December 31, 2019. | ||||||
Security deposit | $ 4,950 | ||||||
Settlement Agreement [Member] | |||||||
Insurance coverage amount | 500,000 | ||||||
Charged for retention requirement | 500,000 | ||||||
Settlement Agreement [Member] | March 8, 2019 [Member] | |||||||
Settlement agreed amount | 2,250,000 | ||||||
Settlement Agreement [Member] | January 14, 2019 [Member] | Watts Action [Member] | |||||||
Payment of attorney' fees | $ 200,000 | ||||||
Settlement Agreement [Member] | ChubeWorkx [Member] | |||||||
Percentage of royalty received | 5.00% | ||||||
Percentage of royalty retain | 50.00% | ||||||
Due to related parties owned | $ 549,609 | ||||||
Settlement Agreement [Member] | ChubeWorkx [Member] | Royalty [Member] | |||||||
Royalty revenue | $ 5,000,000 | ||||||
Marketing Contract [Member] | |||||||
Allegations, description | On November 15, 2018, Typenex Medical LLC ("Typenex"), a telemarketing entity with whom the Company had entered into a marketing and commission agreement dated September 30, 2016 (the "Marketing Contract"), filed an arbitration against the Company before JAMS ADR (the "Arbitration"), and an arbiter was appointed to the Arbitration on December 14, 2018. In the Arbitration, Typenex has stated that it seeks "at least" $220,500 based on the allegation that the Marketing Contract entitles Typenex to a commission on sales of certain of the Company's heparin-related products in the period two years from the Marketing Contract's expiration | ||||||
Marketing Contract [Member] | Minimum [Member] | |||||||
Payment of attorney' fees | $ 220,500 |
Schedule of Lease Commitments (
Schedule of Lease Commitments (Details) | Dec. 31, 2018USD ($) |
Lease commitments, Next 12 Months | $ 181,110 |
Thorofare Lease [Member] | |
Lease commitments, Next 12 Months | 132,000 |
Ramsey Lease [Member] | |
Lease commitments, Next 12 Months | 4,330 |
Pitman Lease [Member] | |
Lease commitments, Next 12 Months | 39,650 |
Equipment Operating Lease [Member] | |
Lease commitments, Next 12 Months | $ 5,130 |
Related Parties (Details Narrat
Related Parties (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Impairment of intangible assets | $ 716,148 | |
Financial Consulting Strategies LLC [Member] | ||
Trade and other payables - related Party | 29,407 | |
Paid to related party | 104,749 | |
Hainan Savy Akers Biosciences, Ltd. [Member] | ||
Proceeds from contributed capital | $ 64,091 | |
Ownership percentage | 19.90% | |
Impairment of intangible assets | $ 64,091 | |
Payments to acquire plastic and electronic components | 20,936 | $ 41,731 |
Trade and other payables - related Party | $ 0 |
Revenue Information (Details Na
Revenue Information (Details Narrative) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
People's Republic of China [Member] | ||
Long-lived assets | $ 14,294 | $ 59,830 |
United States [Member] | ||
Long-lived assets | $ 312,573 | $ 1,305,950 |
Revenue Information - Schedule
Revenue Information - Schedule of Revenue by Product Lines (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Total product Revenues | $ 1,665,570 | $ 3,354,712 |
Product Revenue [Member] | ||
Total product Revenues | 1,665,570 | 3,304,712 |
License Fee | 50,000 | |
Total revenue | 1,665,570 | 3,354,712 |
MicroParticle Catalyzed Biosensor ("MPC") [Member] | ||
Total product Revenues | 123,941 | 381,228 |
Particle ImmunoFiltration Assay ("PIFA") [Member] | ||
Total product Revenues | 1,422,361 | 2,232,684 |
Rapid Enzymatic Assay ("REA") [Member] | ||
Total product Revenues | 68,750 | 133,848 |
Other [Member] | ||
Total product Revenues | $ 50,518 | $ 556,952 |
Revenue Information - Schedul_2
Revenue Information - Schedule of Revenue by Geographic Area Determined Based On Location of Customers (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Total Revenues | $ 1,665,570 | $ 3,354,712 |
United States [Member] | ||
Total Revenues | 1,576,765 | 2,679,549 |
People's Republic of China [Member] | ||
Total Revenues | 502,131 | |
Rest of World [Member] | ||
Total Revenues | $ 88,805 | $ 173,032 |
Employee Benefit Plan (Details
Employee Benefit Plan (Details Narrative) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Percentage of matching contribution | 100.00% |
Percentage of employers contribution based upon employee's pay | 3.00% |
Employer contribution amount | $ 55,360 |
401 K Plan Matches 50% [Member] | |
Percentage of matching contribution | 50.00% |
Percentage of employers contribution based upon employee's pay | 3.00% |
401 K Plan Maximum 5% [Member] | |
Percentage of matching contribution | |
Percentage of employers contribution based upon employee's pay | 5.00% |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - shares | Mar. 29, 2019 | Dec. 31, 2018 |
Number of shares granted | ||
Subsequent Event [Member] | Restricted Stock Units (RSUs) [Member] | ||
Number of shares granted | 124,827 |