Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 01, 2019 | Jun. 29, 2018 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | Chembio Diagnostics, Inc. | ||
Entity Central Index Key | 0001092662 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Shell Company | false | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Ex Transition Period | false | ||
Entity Public Float | $ 154,594,062 | ||
Entity Common Stock, Shares Outstanding | 17,166,459 | ||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 12,524,551 | $ 3,790,302 |
Accounts receivable, net of allowance for doubtful accounts of $42,000 at December 31, 2018 and 2017, respectively | 7,373,971 | 2,085,340 |
Inventories, net | 7,851,222 | 4,423,618 |
Prepaid expenses and other current assets | 702,010 | 554,383 |
TOTAL CURRENT ASSETS | 28,451,754 | 10,853,643 |
FIXED ASSETS, net of accumulated depreciation | 2,873,920 | 1,909,232 |
OTHER ASSETS: | ||
Intangible assets, net | 3,884,831 | 1,597,377 |
Goodwill | 4,983,127 | 1,666,610 |
Deposits and other assets | 717,551 | 589,159 |
TOTAL ASSETS | 40,911,183 | 16,616,021 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued liabilities | 5,888,681 | 3,046,303 |
Deferred revenue | 422,905 | 50,000 |
Current portion of note payable | 207,694 | 0 |
TOTAL CURRENT LIABILITIES | 6,519,280 | 3,096,303 |
OTHER LIABILITIES: | ||
Notes payable | 171,821 | 99,480 |
Deferred tax liability | 892,308 | 341,042 |
TOTAL LIABILITIES | 7,583,409 | 3,536,825 |
COMMITMENTS AND CONTINGENCIES (Note 13) | ||
STOCKHOLDERS' EQUITY: | ||
Preferred stock - 10,000,000 shares authorized; none outstanding | 0 | 0 |
Common stock - $.01 par value; 100,000,000 shares authorized, 17,166,459 and 12,318,570 shares issued and outstanding at December 31, 2018 and 2017, respectively | 171,664 | 123,185 |
Additional paid-in capital | 90,953,788 | 62,821,288 |
Accumulated deficit | (57,909,874) | (50,044,225) |
Accumulated other comprehensive income | 112,196 | 178,948 |
TOTAL STOCKHOLDERS' EQUITY | 33,327,774 | 13,079,196 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 40,911,183 | $ 16,616,021 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
CURRENT ASSETS: | ||
Accounts receivable, allowance for doubtful accounts | $ 42,000 | $ 42,000 |
STOCKHOLDERS' EQUITY: | ||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 17,166,459 | 12,318,570 |
Common stock, shares outstanding (in shares) | 17,166,459 | 12,318,570 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
REVENUES: | ||
TOTAL REVENUES | $ 33,409,251 | $ 24,015,427 |
COSTS AND EXPENSES: | ||
Cost of product sales | 21,427,243 | 12,921,157 |
Research and development expenses | 8,526,256 | 8,555,381 |
Selling, general and administrative expenses | 11,100,775 | 8,963,363 |
Acquisition costs | 337,645 | 58,076 |
TOTAL OPERATING EXPENSES | 41,391,919 | 30,497,977 |
LOSS FROM OPERATIONS | (7,982,668) | (6,482,550) |
OTHER INCOME (EXPENSE): | ||
Interest income, net | 49,498 | 22,485 |
LOSS BEFORE INCOME TAXES (BENEFIT) PROVISION | (7,933,170) | (6,460,065) |
Income tax (benefit) provision | (67,521) | (88,305) |
NET LOSS | $ (7,865,649) | $ (6,371,760) |
Basic loss per share (in dollars per share) | $ (0.55) | $ (0.52) |
Diluted loss per share (in dollars per share) | $ (0.55) | $ (0.52) |
Weighted average number of shares outstanding, basic (in shares) | 14,432,505 | 12,300,031 |
Weighted average number of shares outstanding, diluted (in shares) | 14,432,505 | 12,300,031 |
Net Product Sales [Member] | ||
REVENUES: | ||
TOTAL REVENUES | $ 26,741,020 | $ 19,322,302 |
License and Royalty Revenue [Member] | ||
REVENUES: | ||
TOTAL REVENUES | 948,773 | 741,534 |
R&D and Grant Revenue [Member] | ||
REVENUES: | ||
TOTAL REVENUES | $ 5,719,458 | $ 3,951,591 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS [Abstract] | ||
Net loss | $ (7,865,649) | $ (6,371,760) |
Other comprehensive income: | ||
Foreign currency translation adjustments | (66,752) | 178,948 |
COMPREHENSIVE LOSS | $ (7,932,401) | $ (6,192,812) |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) | Common Stock [Member] | Additional Paid-in-Capital [Member] | Accumulated Deficit [Member] | AOCI [Member] | Total |
Balance at Dec. 31, 2016 | $ 120,268 | $ 60,721,783 | $ (43,672,465) | $ 0 | $ 17,169,586 |
Balance (in shares) at Dec. 31, 2016 | 12,026,847 | ||||
Common Stock: | |||||
Purchase of RVR Diagnostics Sdn Bhd | $ 2,692 | 1,680,033 | 0 | 0 | 1,682,725 |
Purchase of RVR Diagnostics Sdn Bhd (in shares) | 269,236 | ||||
Options: | |||||
Exercised | $ 225 | 34,575 | 0 | 0 | $ 34,800 |
Exercised (in shares) | 22,487 | 22,487 | |||
Stock option compensation | $ 0 | 384,897 | 0 | 0 | $ 384,897 |
Comprehensive income (loss) | 0 | 0 | 0 | 178,948 | 178,948 |
Net loss | 0 | 0 | (6,371,760) | 0 | (6,371,760) |
Balance at Dec. 31, 2017 | $ 123,185 | 62,821,288 | (50,044,225) | 178,948 | 13,079,196 |
Balance (in shares) at Dec. 31, 2017 | 12,318,570 | ||||
Common Stock: | |||||
New stock from offerings | $ 45,098 | 27,431,162 | 0 | 0 | 27,476,260 |
New stock from offerings (in shares) | 4,509,760 | ||||
Restricted stock issued | $ 2,668 | (2,668) | 0 | 0 | 0 |
Restricted stock issued (in shares) | 266,839 | ||||
Restricted stock compensation | $ 0 | 281,249 | 0 | 0 | 281,249 |
Options: | |||||
Exercised | $ 713 | 71,201 | 0 | 0 | $ 71,914 |
Exercised (in shares) | 71,290 | 71,290 | |||
Stock option compensation | $ 0 | 351,556 | 0 | 0 | $ 351,556 |
Comprehensive income (loss) | 0 | 0 | 0 | (66,752) | (66,752) |
Net loss | 0 | 0 | (7,865,649) | 0 | (7,865,649) |
Balance at Dec. 31, 2018 | $ 171,664 | $ 90,953,788 | $ (57,909,874) | $ 112,196 | $ 33,327,774 |
Balance (in shares) at Dec. 31, 2018 | 17,166,459 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Cash received from customers and grants | $ 28,632,084 | $ 24,971,299 |
Cash paid to suppliers and employees | (40,452,110) | (30,028,299) |
Income taxes paid | (10,913) | 0 |
Interest received, net | 69,930 | 22,485 |
Interest paid | (20,432) | 0 |
Net cash used in operating activities | (11,781,441) | (5,034,515) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of opTricon GmbH, net of cash acquired | (5,491,204) | 0 |
Purchase of RVR Diagnostics Sdn Bhd, net of cash acquired | 0 | (850,000) |
Acquisition of and deposits on fixed assets | (1,467,192) | (1,026,954) |
Net cash used in investing activities | (6,958,396) | (1,876,954) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from option exercises | 71,914 | 34,800 |
Proceeds from note payable | 0 | 99,480 |
Payments on note payable | (64,481) | 0 |
Proceeds from sale of common stock, net | 27,476,260 | 0 |
Net cash provided by financing activities | 27,483,693 | 134,280 |
Effect of exchange rate changes on cash | (9,607) | 13,027 |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 8,734,249 | (6,764,162) |
Cash and cash equivalents - beginning of the period | 3,790,302 | 10,554,464 |
Cash and cash equivalents - end of the period | 12,524,551 | 3,790,302 |
RECONCILIATION OF NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES | ||
Net loss | (7,865,649) | (6,371,760) |
Adjustments: | ||
Depreciation and amortization | 902,505 | 1,276,963 |
Fair value adjustment to contingent consideration | 0 | (148,000) |
Share based compensation | 632,805 | 384,897 |
Change in deferred tax assets | (78,432) | 0 |
Changes in assets and liabilities, net of effects from purchase of opTricon GmbH: | ||
Accounts receivable | (5,150,072) | 1,298,389 |
Inventories | (3,077,104) | (1,088,430) |
Prepaid expenses and other current assets | (118,293) | 285,762 |
Deposits and other assets | 0 | (512,272) |
Accounts payable and accrued liabilities | 2,599,894 | 182,453 |
Deferred revenue | 372,905 | (342,517) |
Net cash used in operating activities | (11,781,441) | (5,034,515) |
Supplemental disclosures for non-cash investing and financing activities: | ||
Deposits on manufacturing equipment transferred to fixed assets | 257,455 | 174,399 |
Deposits and other assets transferred to intangible assets | 118,899 | 0 |
Seller-financed equipment purchases | 326,110 | 0 |
Accrual of contingent earn-out | 0 | 148,000 |
Issuance of common stock for net assets of business acquired | $ 0 | $ 1,682,725 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 12 Months Ended |
Dec. 31, 2018 | |
DESCRIPTION OF BUSINESS [Abstract] | |
DESCRIPTION OF BUSINESS | NOTE 1 — DESCRIPTION OF BUSINESS: Chembio Diagnostics, Inc. and its subsidiaries (collectively, the “Company” or “Chembio”), develop, manufacture, and commercialize point-of-care diagnostic tests that are used to detect and diagnose diseases. The Company is pursuing three corporate priorities: (1) expand its commercialization, (2) advance its research and development pipeline, and (3) prepare for future growth. All products that are currently being developed are based on the Company’s patented DPP ® The Company’s product commercialization and product development efforts are focused on infectious disease testing and technology collaborations. In infectious disease, the Company is commercializing tests for HIV and Syphilis, Zika virus, and developing tests for malaria, dengue virus, chikungunya virus, ebola, lassa Rickettsia typhi Burkholderia pseudomallei Orientia tsutsugamushi Large and growing markets have been established for these kinds of tests, initially in high prevalence regions where they are indispensable for large scale prevention and treatment programs. More generally, the Company believes there is and will continue to be a growing demand for diagnostic products that can provide accurate, actionable diagnostic information in a rapid, cost-effective manner at the point of care. The Company’s products are sold to medical laboratories and hospitals, governmental and public health entities, non-governmental organizations, medical professionals and retail establishments, both domestically and internationally, under the Company’s STAT PAK ®, ® ® ® The Company routinely enters into arrangements with governmental and non-governmental organizations for the funding of certain research and development efforts. |
ACQUISITIONS
ACQUISITIONS | 12 Months Ended |
Dec. 31, 2018 | |
ACQUISITIONS [Abstract] | |
ACQUISITIONS | NOTE 2 — ACQUISITIONS: opTricon On November 6, 2018, pursuant to a share purchase agreement, the Company acquired all of the outstanding shares of opTricon GmbH (“opTricon”), a privately-held Germany based developer and manufacturer of handheld analyzers for rapid diagnostic tests, for $5.5 million in cash, subject to routine post-closing adjustments. Since 2015, the Company and opTricon have been parties to an agreement under which the Company has collaborated in developing its DPP Micro Reader, a handheld, battery-operated analyzer that uses an innovative image sensor to provide, when combined with the Company’s DPP tests, a quantitative interpretation of diagnostic results. The Company purchased opTricon because it believes it will enable it to promote DPP tests and DPP Micro Reader more actively across global markets. The results of opTricon operations have been reflected in the consolidated financial statements since November 6, 2018. As a result of the consideration paid exceeding the preliminary fair value of the net assets acquired, goodwill in the amount of $3,337,000 was recorded in connection with this acquisition, none of which will be deductible for tax purposes. In addition, the Company recorded $2,260,000 in intangible assets associated with the addition of opTricon’s developed technology and customer base. The Consolidated Statements of Operations for the year ended December 31, 2018 include $337,645 of transaction costs related to the opTricon acquisition. The acquisition was accounted for using the purchase method of accounting. The following table summarizes the preliminary allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed on the closing date of November 6, 2018: Amount Net current assets $ 404,204 Property, plant and equipment 125,000 Goodwill 3,337,000 Deferred tax liability (635,000 ) Other intangible assets (estimated useful life): Developed technology (7 years) 1,900,000 Customer contracts / relationships (10 years) 360,000 Total consideration $ 5,491,204 The Company calculated the fair value of the fixed assets based on the net book value of opTricon as that approximates fair value. The developed technology and customer contracts/relationships were based on discounted cash flows using management estimates. As indicated, the allocation of the purchase price shown above is preliminary, pending completion of an analysis of the deferred tax liability. Therefore, an adjustment may be required. The following represents unaudited pro forma operating results for the year ended December 31, 2018 as if the operations of opTricon had been included in the Company’s Consolidated Statements of Operations as of January 1, 2018: Proforma December 31, 2018 Total revenues $ 35,442,806 Net loss (8,394,074 ) Net loss per common share $ (0.58 ) Diluted net loss per common share $ (0.58 ) The pro forma financial information includes business combination accounting effects from the acquisition including amortization charges from acquired intangible assets of opTricon approximately $351,000 for the year ended December 31, 2018. The unaudited pro forma information as presented above is for informational purposes only and is not indicative of the results of operations that would have been achieved if the acquisition had taken place at the beginning of fiscal 2018. Included in the proforma table above are opTricon's net revenues and pre-tax loss for the year ended December 31, 2018 which were approximately $2,214,000 and $213,000, respectively. opTricon's results of operations from the date of acquisition through December 31, 2018 are immaterial to the Company's Consolidated Statements of Operations. RVR Diagnostics On January 9, 2017, pursuant to a stock purchase agreement (the "Stock Purchase Agreement), the Company acquired all of the outstanding common stock of RVR Diagnostics Sdn Bhd ("RVR"), a privately-held Malaysia based manufacturing company focused on assembly and sales of rapid medical assays, for $3,231,000. The Company acquired RVR, which subsequently changed its name to Chembio Diagnostics Malaysia Sdn Bhd ("CDM"), to have a better presence in Asia, access to lower cost, shorter approval time of in-country regulatory approvals, and a lower cost assembly operation. Total consideration was: (i) a cash payment of $1,400,000, of which $550,000 was paid as a deposit in December 2016; (ii) 269,236 shares of Chembio's common stock, with a value at closing of $1,683,000, of which 7,277 shares were held back to satisfy certain potential claims under the Stock Purchase Agreement and became issuable to the sellers on the one-year anniversary of the closing; and, a contingent $148,000 milestone payment based on the achievement of performance goals related to sales by CDM during the 12 months ended December 31, 2017. The performance goals were not achieved and the related $148,000 accrual was reversed during the fourth quarter of 2017 and recognized in Selling, general, and administrative expenses associated with the change in fair value. As a result of the consideration paid exceeding the preliminary fair value of the net assets acquired, goodwill in the amount of $1,503,361 was recorded in connection with this acquisition, none of which will be deductible for tax purposes. In addition, the Company recorded $1,800,000 in intangible assets associated with the addition of CDM’s intellectual property, customer base and distribution channels, trade names, order backlog, industry reputation, and management talent and workforce. The acquisition was accounted for using the purchase method of accounting. The following table summarizes the allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed on the closing date of January 9, 2017: Amount Property, plant and equipment $ 235,141 Goodwill 1,651,361 Deferred tax liability (307,636 ) Contingent consideration (148,000 ) Other intangible assets (estimated useful life): Intellectual property (10 years) 800,000 Customer contracts / relationships (10 years) 700,000 Order backlog (3 months) 200,134 Trade name (11 years) 100,000 Total consideration $ 3,231,000 The Company calculated the fair value of the fixed assets based on the net book value of CDM as that approximates fair value. The intellectual property, customer contracts and trade names were based on discounted cash flows using management estimates. The order backlog was based on an order that CDM had at the closing that was shipped in the first quarter of 2017, and valued at an estimated net income. CDM's net revenues and pre-tax loss for the year ended December 31, 2017 were approximately $ 1,465,000 and ($406,000), |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2018 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 3 — SIGNIFICANT ACCOUNTING POLICIES: (a) Principles of Consolidation: The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany transactions and balances are eliminated in consolidation. Certain amounts from prior years have been reclassified to conform to the 2018 presentation. (b) Use of Estimates: The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make assumptions and estimates that affect the amounts reported in the consolidated financial statements and accompanying notes. Judgments and estimates of uncertainties are required in applying the Company’s accounting policies in certain areas. Generally, matters subject to estimation and judgment include accounts receivable realization, inventory obsolescence, asset impairments, recognition of revenue persuant to milestones, useful lives of intangible and fixed assets, stock-based compensation, and deferred tax asset valuation allowances. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be based upon amounts that differ from those estimates. (c) Fair Value of Financial Instruments: The carrying value for cash and cash equivalents, accounts receivable, and accounts payable, approximate fair value due to the immediate or short-term maturity of these financial instruments. Included in cash and cash equivalents is $4.7 million and $2.1 million as of December 31, 2018 and 2017, respectively, of money market funds that are Level 1 fair value measurements under the hierarchy. The fair value of the Company's notes payable approximates the recorded value as the rate is based upon the current rates offered to the Company for similar financial instruments. Fair value measurements of all financial assets and liabilities that are being measured and reported on a fair value basis are required to be classified and disclosed in one of the following three categories: Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). (d) Cash and Cash Equivalents: Cash and cash equivalents are defined as short-term, highly liquid investments with original maturities of three months or less. (e) Concentrations of Credit Risk: Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of temporary cash investments and trade receivables. The Company places its temporary cash instruments with well-known financial institutions and, at times, may maintain balances in excess of the FDIC insurance limit. The Company monitors the credit ratings of the financial institutions to mitigate this risk. Concentration of credit risk with respect to trade receivables is principally mitigated by the Company’s ability to obtain letters of credit from certain foreign customers and its diverse customer base, both in number of customers and geographic locations. (f) Inventories: Inventories, consisting of material, labor and manufacturing overhead, are stated at the lower of cost and net realizable value. Cost is determined on the first-in, first-out method. The Company’s policy is to periodically evaluate the market value of the inventory and the stage of product life cycle, and record a write-down for any inventory considered slow moving or obsolete. (g) Fixed Assets: Fixed assets are stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets, which range from three to seven years. Leasehold improvements are amortized over the useful life of the asset or the lease term, whichever is shorter. Deposits paid for fixed assets are capitalized and not depreciated until the related asset is placed in service. (h) License Agreements: The Company records up-front payments related to sublicense agreements as prepaids and amortizes them over their respective economic life. As of December 31, 2018 and 2017, total prepaids were $100,000 and $100,000, respectively. Amortization expenses for the licenses above for the years ended December 31, 2018, and 2017 were $0, and $137,500, respectively. (i) Valuation of Long-Lived Assets and Intangible Assets: Long-lived assets to be held and used are analyzed for impairment whenever events or changes in circumstances indicate that the related carrying amounts may not be recoverable. The Company evaluates at each balance sheet date whether events and circumstances have occurred that indicate possible impairment. If there are indications of impairment, the Company uses future undiscounted cash flows of the related asset or asset grouping over the remaining life in measuring whether the assets are recoverable. In the event such cash flows are not expected to be sufficient to recover the recorded asset values, the assets are written down to their estimated fair value. No impairment of long-lived tangible and intangible assets was recorded for the years ended December 31, 2018 and 2017. (j) Revenue Recognition: In May 2014, the Financial Accounting Standards Board (“FASB”) issued converged guidance on recognizing revenue in contracts with customers, Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers The new revenue standards became effective for the Company on January 1, 2018 and were adopted using the modified retrospective method. The adoption of the new revenue standards as of January 1, 2018 did not change the Company’s revenue recognition as its revenues continue to be recognized when the customer takes control of its product. As the Company did not identify any material accounting changes that impacted the amount of reported revenues with respect to its product revenue, license and royalty revenue, and R&D, milestone and grant revenues, no adjustment to retained earnings was required upon adoption. The Company adopted the standards to contracts that were not completed at the date of initial application (January 1, 2018). Under the new revenue standards, the Company recognizes revenues when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. The Company recognizes revenues following the five-step model prescribed under ASU No. 2014-09: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) the Company satisfies the performance obligation. Product Revenues Revenues from product sales are recognized and commissions are accrued when the customer obtains control of the Company’s product, which occurs at a point in time, typically upon tendering to the customer. The Company expenses incremental costs of obtaining a contract as and when incurred because the expected amortization period of the asset that it would have recognized is one year or less or the amount is immaterial. Freight and distribution activities on products are performed after the customer obtains control of the goods. The Company has made an accounting policy election to account for shipping and handling activities that occur either when or after goods are tendered to the customer as a fulfillment activity, and therefore recognizes freight and distribution expenses in Cost of Product Sales. The Company’s payment terms vary by the type and location of the Company’s customer and products or services offered. Payment terms differ by jurisdiction and customer but payment is generally required in a term ranging from 30 to 60 days from date of shipment or satisfaction of the performance obligation. Reserves for Discounts and Allowances Revenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with the Company’s customers. The Company’s process for estimating reserves established for these variable consideration components does not differ materially from its historical practices. Product revenue reserves, which are classified as a reduction in product revenues, are generally related to discounts. Estimates of variable consideration and the determination of whether to include estimated amounts in the transaction price are based on all information (historical, current and forecasted) that is reasonably available to the Company, taking into consideration the type of customer, the type of transaction and the specific facts and circumstances of each arrangement. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from the Company’s estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment. Royalty Revenues The Company receives royalty revenues on sales by its licensees of products covered under patents that it owns. The Company does not have future performance obligations under these license arrangements. The Company records these revenues based on estimates of the sales that occurred during the relevant period as a component of license and royalty revenues. The relevant period estimates of sales are based on interim data provided by licensees and analysis of historical royalties that have been paid to the Company, adjusted for any changes in facts and circumstances, as appropriate. Differences between actual and estimated royalty revenues are adjusted for in the period in which they become known, typically the following quarter. Historically, adjustments have not been material when compared to actual amounts paid by licensees. R&D and grant revenue All such contracts are evaluated under the five-step model described above. For certain contracts that represent grants where the funder does not meet the definition of a customer, the Company recognizes revenue when earned in accordance with ASC 958. Such contracts are further described under Disaggregation of Revenue Disaggregation of Revenue The following tables disaggregate Total Revenues for the year ended December 31, 2018: Exchange Transactions Non-Exchange Transactions Total Net product sales $ 26,741,020 $ - $ 26,741,020 License and royalty revenue 948,773 - 948,773 R&D, milestone and grant revenue 2,687,210 3,032,248 5,719,458 $ 30,377,003 $ 3,032,248 $ 33,409,251 Exchange transactions are recognized in accordance with ASC 606, while non-exchange transactions are recognized in accordance with ASC 985. Total Africa $ 8,605,306 Asia 1,389,120 Europe & Middle East 4,726,691 Latin America 11,722,224 United States 6,965,910 $ 33,409,251 Contract Liabilities Deferred revenue relates to payments received in advance of performance under the contract. Deferred revenue is recognized as revenue as (or when) the Company performs under the contract. At December 31, 2017, the Company reported $50,000 in deferred revenue of which $50,000 was earned and recognized as R&D, milestone and grant revenue during the year ended December 31, 2018. At December 31, 2018, the Company reported $422,905 in deferred revenue which is expected to be recognized during the first quarter of 2019. In April 2017, the Company entered into a $1.0 million agreement with FIND to develop a simple, point-of-care fever panel assay that can identify multiple life-threatening acute febrile illnesses common in the Asia Pacific region. The Company earned $0.1 million and $0.9 million for the year ended December 31, 2018, and from inception through December 31, 2018, respectively as R&D, milestone and grant revenue in the Company’s Consolidated Statements of Operations. In August 2016, the Company was awarded a grant of $5.9 million from BARDA, which is part of the U.S. Department of Health And Human Resources to develop a rapid Zika virus assay. The Company earned $2.6 million and $5.3 million for the year ended December 31, 2018 and from inception through December 31, 2018, respectively, as R&D, milestone and grant revenue in the Company’s Consolidated Statements of Operations. In September 2016, the Company was awarded a $0.7 million contract from the USDA to develop a Bovid TB assay. The Company earned $0.2 million and $0.5 million for the year ended December 31, 2018 and from inception through December 31, 2018, respectively, as R&D, milestone and grant revenue in the Company’s Consolidated Statements of Operations. (k) Research and Development: Research and development (R&D) costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. (l) Stock-Based Compensation: The fair value of restricted stock and restricted stock unit awards are their fair value on the date of grant. Stock-based compensation expense for stock options is calculated using the Black-Scholes valuation model based on awards ultimately expected to vest together with the fair value of restricted stock and restricted stock unit awards, are, reduced for actual forfeitures, and, expensed on a straight-line basis over the requisite service period of the grant. During 2017, the Company adopted ASU 2016-09, "Improvements to Employee Share-Based Payment Accounting". (m) I ncome Taxes: The Company accounts for income taxes under an asset and liability approach that recognizes deferred tax assets and liabilities based on the difference between the financial statement carrying amounts and the tax bases of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. The Company follows a more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. The guidance relates to, among other things, classification, accounting for interest and penalties associated with tax positions, and disclosure requirements. Any interest and penalties accrued related to uncertain tax positions are recorded in tax expense. The Company assesses the realizability of its net deferred tax assets on an annual basis. If, after considering all relevant positive and negative evidence, it is more likely than not that some portion or all of the net deferred tax assets will not be realized, the Company will reduce the net deferred tax assets by a valuation allowance. The realization of net deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of net operating loss carryforwards. (n) Loss Per Share: Basic loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period including outstanding restricted stock that by its terms is includible in the calculation. Diluted loss per share for the years ended December 31, 2018, and 2017 reflects the potential dilution from the exercise or conversion of other securities into common stock, if dilutive. There were 711,968, and 810,670 options outstanding as of December 31, 2018 and 2017, respectively, which were not included in the calculation of diluted income per share for the years ended because their effect would have been anti-dilutive. (o) Goodwill and Intangible Assets: Goodwill represents the excess of the purchase price the Company paid over the fair value of the net tangible and identifiable intangible assets acquired in the Company’s acquisition of opTricon in November 2018 and CDM in January 2017. Goodwill is not amortized but rather is tested annually as of the first day of the fiscal fourth quarter, or sooner if the Company believes that indicators of impairment exist. The Company makes a qualitative evaluation about the likelihood of goodwill impairment, which is based on a number of applicable factors. If the Company concludes that it is more likely than not that the carrying value of the applicable reporting unit is greater than its fair value, then it would recognize an impairment charge for the amount by which the carrying value exceeds the reporting unit’s fair value, provided the impairment charge does not exceed the total amount of goodwill allocated to the reporting unit. For the year ended December 31, 2018 and 2017, there was no impairment of goodwill and other intangible assets. Following is a table that reflects changes in Goodwill: Beginning balance 1/1/18 $ 1,666,610 Acquisition of opTricon 3,337,000 Changes in foreign currency exchange rate (20,483 ) Balance at December 31, 2018 $ 4,983,127 Intangible assets consist of the following at: Weighted Average Remaining Life December 31, 2018 December 31, 2017 Cost Accumulated Amortization Net Book Value Cost Accumulated Amortization Net Book Value Intellectual property 10 $ 1,089,688 $ 173,633 $ 916,055 $ 886,872 $ 88,687 $ 798,185 Developed technology 7 1,910,315 - 1,910,315 - - - Customer contracts/relationships 8 1,121,600 151,929 969,671 776,013 77,601 698,412 Order backlog - 217,187 217,187 - 221,867 221,867 - Trade names 9 108,521 19,731 88,790 110,859 10,079 100,780 $ 4,447,311 $ 562,480 $ 3,884,831 $ 1,995,611 $ 398,234 $ 1,597,377 Amortization expense for the year ended December 31, 2018 and 2017 was $233,734 and $398,234, respectively, and is recorded within Selling, General and Administrative expenses. Amortization expense, subject to changes in currency exchange rates, is expected to be $496,512 per year from 2019 through 2023, and total $1,402,271 for all of the years thereafter. (p) Allowance for Doubtful Accounts: The Company records allowances for doubtful accounts for the estimated probable losses on uncollectible accounts receivable. The allowance is based upon the credit worthiness of the Company’s customers, the Company’s historical experience, the age of the receivable and current market and economic conditions. Receivables are written off against these allowances in the period they are determined to be uncollectible. (q) Acquisition Costs: Acquisition costs include period expenses, primarily professional services, related to acquisition activities. (r) Foreign Currency Translation: The functional currency of a foreign subsidiary is the local currency. Assets and liabilities of foreign subsidiaries that use a currency other than U.S. dollars as their functional currency are translated to U.S. dollars at end of period currency exchange rates. The consolidated statements of operations of foreign subsidiaries are translated to U.S. dollars at average period currency exchange rates. The effect of translation for foreign subsidiaries is generally reported in Other comprehensive income. Foreign transaction gains are immaterial. (s) Recent Accounting Pronouncements Affecting the Company: In May 2014, the Financial Accounting Standards Board (“FASB”) issued converged guidance on recognizing revenue in contracts with customers, Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers The Company has completed its evaluation of the new standard and assessed the impact of adoption on its consolidated financial statements. The Company reviewed significant open contracts with customers for each revenue stream, and based on its evaluation, revenue recognition under the new standard did not have a material impact on the Company’s consolidated financial statements because: i) product sales revenue is recognized when control of the goods is transferred to the customer (i.e., the date of shipment, which is consistent under ASC 605), and ii) R&D and grant revenue historically did not constitute exchange transactions and therefore the new standard did not apply to such revenue upon adoption. The Company also assessed its control framework as a result of adopting the new standard and noted minimal, insignificant changes to its systems and other controls processes. The new standard permitted two adoption methods under ASU 2014-09. The guidance could be adopted through either retrospective application to all periods presented in the consolidated financial statements (full retrospective) or through a cumulative effect adjustment to retained earnings at the effective date (modified retrospective). The Company adopted the new standard effective January 1, 2018 using the modified retrospective transition method. Under that method, the Company applied the rules to all contracts existing as of January 1, 2018. The cumulative effect was not material. In November 2015, the FASB issued ASU 2015-17, Income Taxes (Topic 740) Balance Sheet Classification of Deferred Assets In Leases Codification Improvements to Topic 842, Leases Leases (Topic 842) Targeted Improvements The Company will adopt Topic 842 on January 1, 2019 under the optional transition method and elect the short-term lease exception and available practical expedients. Under the transition method, the Company will not adjust its comparative period financial information or make the new required lease disclosures for periods before the effective date. Upon adoption, the Company expects the consolidated balance sheet to include a right of use asset and liability related to substantially all of the Company’s lease arrangements. While the Company continues to evaluate the effects of adopting the provisions of Topic 842, including the impact that this new guidance will have on its processes and controls, the Company expects most existing operating lease commitments will be recognized as operating lease liabilities and right-of-use assets upon adoption. The adoption is not expected to be material to the consolidated financial statements, and based on the Company’s ongoing assessment, is expected to increase total assets and total liabilities by no more than approximately $1.5 million, on a discounted basis. Please In March 2016, the FASB issued authoritative guidance under ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments The Company adopted ASU 2016-15 in the first quarter of 2018. In January 2017, the FASB issued ASU 2017-04, Intangibles-Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting The Company adopted ASU 2017-09 in the first quarter of 2018. In July 2018, the FASB issued ASU 2018-08 N ot-for-Profit Entities (Topic 958): Clarifying the Scope and the Accounting Guidance for Contributions Received and Contributions Made to clarify the accounting guidance related to contributions made or received. This guidance primarily affects not-for-profit entities, although it also applies to businesses to the extent that they make or receive contributions, including grants. ASU 2018-08 clarifies and improves the scope and accounting guidance for both contributions received and made in order to assist entities in evaluating if those transactions should be accounted for as contributions under the scope of Topic 958, or as an exchange transaction subject to other guidance. Public entities are required to apply the amendments on contributions received and contributions made to annual periods beginning after June 15, 2018, and December 15, 2018, respectively, each including interim periods within those annual periods. Early adoption is permitted, and the Company adopted ASU 2018-08 effective as of January 1, 2018. The impact of adoption was immaterial. |
INVENTORIES
INVENTORIES | 12 Months Ended |
Dec. 31, 2018 | |
INVENTORIES [Abstract] | |
INVENTORIES | NOTE 4 — INVENTORIES: Inventories consist of the following at: December 31, 2018 December 31, 2017 Raw Materials $ 2,803,677 $ 1,767,684 Work in Process 263,043 286,413 Finished Goods 4,784,502 2,369,521 $ 7,851,222 $ 4,423,618 |
FIXED ASSETS
FIXED ASSETS | 12 Months Ended |
Dec. 31, 2018 | |
FIXED ASSETS [Abstract] | |
FIXED ASSETS | NOTE 5 — FIXED ASSETS: Fixed assets consist of the following at: December 31, 2018 December 31, 2017 Machinery and Equipment $ 6,070,137 $ 4,582,759 Furniture and Fixtures 35,287 449,548 Computer Equipment 435,348 422,946 Leasehold Improvements 2,334,512 2,258,779 Enterprise Business Systems 462,420 - Less: Accumulated Depreciation and Amortization (6,463,784 ) (5,804,800 ) $ 2,873,920 $ 1,909,232 There were no capital leases at the end of December 31, 2018. Fixed assets at December 31, 2018 also include $1,866,126 in equipment that is undergoing validation and as such is not yet being depreciated. Depreciation expense for the 2018 and 2017 years totaled $634,261 and $727,563, respectively. As of December 31, 2018 and 2017, the Company had paid deposits on various pieces of equipment classified within Deposits and Other Assets aggregating $428,859 and $257,455, respectively. |
ACCOUNTS PAYABLE AND ACCRUED LI
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES | 12 Months Ended |
Dec. 31, 2018 | |
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract] | |
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES | NOTE 6 — ACCOUNTS PAYABLE AND ACCRUED LIABILITIES: Accounts payable and accrued liabilities consist of the following at: December 31, 2018 December 31, 2017 Accounts Payable - suppliers $ 3,622,765 $ 1,494,759 Accrued Commissions 588,131 126,827 Accrued Royalties / license fees 279,213 429,297 Accrued Payroll 48,867 187,305 Accrued Vacation 264,789 309,767 Accrued Bonuses 494,318 282,500 Accrued Expenses - Other 590,598 215,848 $ 5,888,681 $ 3,046,303 |
DEFERRED RESEARCH AND DEVELOPME
DEFERRED RESEARCH AND DEVELOPMENT REVENUE | 12 Months Ended |
Dec. 31, 2018 | |
DEFERRED RESEARCH AND DEVELOPMENT REVENUE [Abstract] | |
DEFERRED RESEARCH AND DEVELOPMENT REVENUE | NOTE 7 — DEFERRED RESEARCH AND DEVELOPMENT REVENUE: The Company recognizes income from R&D milestones when those milestones are reached and non-milestone contracts and grants when earned. These projects are invoiced after expenses are incurred. Any projects or grants funded in advance are deferred until earned. As of December 31, 2018 and 2017, there were $422,905 and $50,000 unearned advanced revenues, respectively. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2018 | |
INCOME TAXES [Abstract] | |
INCOME TAXES | NOTE 8 The (benefit from) provision for income taxes for the years ended December 31, 2018 and 2017 is comprised of the following: 2018 2017 Current Federal $ - $ (97,339 ) State 10,914 9,034 Foreign - - Total current (benefit) provision 10,914 (88,305 ) Deferred Federal - - State - - Foreign (78,435 ) - Total deferred (benefit) provision (78,435 ) - Total (benefit) provision $ (67,521 ) $ (88,305 ) On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (the “Tax Act”) was signed into law making significant changes to the Internal Revenue Code. Changes include, but are not limited to, a corporate tax rate decrease from 34% to 21% effective for tax years beginning after December 31, 2017, the transition of U.S international taxation from a worldwide tax system to a territorial system, and a one-time transition tax on the mandatory deemed repatriation of cumulative foreign earnings as of December 31, 2017. The Staff of the Securities and Exchange Commission issued Staff Accounting Bulletin No. 118 ("SAB 118") to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Tax Act. As a result of the Tax Act, the Company remeasured its U.S. Federal deferred tax assets and liabilities at the rate they are expected to reverse in the future. The Company recorded a cumulative charge of $3,906,774 ($0 in 2018 and $3,906,774 in 2017), which was fully offset by an equivalent adjustment to the deferred tax valuation allowance. The Company recorded a cumulative benefit of $97,339 ($0 in 2018 and $97,339 in 2017) related to a credit for alternative minimum taxes (AMT) paid in prior years. During 2018, the Company finalized its computation of the impact of the Tax Act with no change to the provisional amount. In January 2018, the FASB released guidance on the accounting for tax on the global intangible low-taxed income ("GILTI") provisions of the Tax Act. The GILTI provisions impose a tax on foreign income in excess of a deemed return on tangible assets of foreign corporations. The guidance allows companies to make an accounting policy election to either (1) account for GILTI as a component of tax expense in the period in which they are subject to the rules (the period cost method), or (ii) account for GILTI in the Company's measurement of deferred taxes (the deferred method). After completing the analysis of the GILTI provisions, the Company elected to account for GILTI using the period cost method. The Company had an ownership change as described in Internal Revenue Code Sec. 382 during 2004 (“2004 change”). As a result, the Company’s net operating losses prior to the 2004 change of $5,832,516 were subject to an annual limitation of $150,608 and for the first five (5) years are entitled to a BIG (Built-In-Gains) of $488,207 per year. These net operating losses expire in 2019 through 2024. The Company had a second ownership change during 2006 (“2006 change”). The net operating losses incurred between the 2004 change and the 2006 change of $8,586,861 were subject to an annual limitation of $1,111,831 and for the first five (5) years are entitled to a BIG of $1,756,842 per year. These net operating losses expire in 2024 through 2026. After applying the above limitations, at December 31, 2018, the Company has post-change net operating loss carry-forwards of approximately $27,303,044 which expire between 2019 and 2037 and $5,432,085 which do not expire. In addition the Company has research and development tax credit carryforwards of approximately $1,696,870 for the year ended December 31, 2018, which expire between 2019 and 2036. The Company has state net operating loss carryforwards of approximately $1,784,554 which expire between 2025 and 2037. The Company has foreign net operating loss carryforwards of approximately $586,206 which do not expire. 2018 2017 Inventory reserves $ 204,206 $ 244,158 Accrued expenses 175,168 102,332 Net operating loss carry-forwards 7,122,576 5,800,144 Research and development credit 1,696,870 1,918,137 Stock-based compensation 215,797 167,522 Depreciation 139,362 91,258 Total deferred tax assets 9,553,979 8,323,551 Intangibles (968,849 ) (341,042 ) Total deferred tax liabilities (968,849 ) (341,042 ) Net deferred tax assets before valuation allowance 8,585,130 7,982,509 Less valuation allowances (9,477,438 ) (8,323,551 ) Net noncurrent deferred tax liabilities $ (892,308 ) $ (341,042 ) The components of (loss) before income taxes consisted of the following: Year Ending December 31, 2018 2017 United States operations $ (7,137,428 ) $ (6,054,002 ) International operations (795,742 ) (406,063 ) (Loss) before taxes $ (7,933,170 ) $ (6,460,065 ) A reconciliation of the Federal statutory rate to the effective rate applicable to loss before income taxes is as follows: Year Ending December 31, 2018 2017 Federal income tax at statutory rates 21.00 % 34.00 % State income taxes, net of federal benefit (.10 )% (0.09 )% Nondeductible expenses (1.58 )% (1.04 )% Foreign rate differential .36 % (2.14 )% Change in valuation allowance (18.44 )% (99.41 )% Impact of Tax Act on valuation allowance - % 60.48 % AMT refund under Tax Act - % 1.51 % Tax credits - % 7.07 % Other (.39 )% 0.99 % Income tax benefit .85 % 1.37 % Interest and penalties, if any, related to income tax liabilities are included in income tax expense. As of December 31, 2018, the Company does not have a liability for uncertain tax positions. The Company files Federal and state income tax returns, opTricon files in Germany and CDM files in Malaysia and has been on tax holiday which expired on December 31, 2018. With few exceptions, tax years for fiscal 2015 through 2018 are open and potentially subject to examination by federal, state and foreign taxing authorities. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2018 | |
STOCKHOLDERS' EQUITY [Abstract] | |
STOCKHOLDERS' EQUITY | NOTE 9 — STOCKHOLDERS’ EQUITY: (a) Common Stock In February 2018, the Company closed on an underwritten registered public offering of 1,783,760 shares of its common stock at $6.75 per share. The net proceeds of the offering, after deducting the underwriter’s discounts and other offering expenses payable by the Company, was approximately $10.9 million. In November 2018, the Company closed on an underwritten public offering of 2,726,000 shares of its common stock, including the underwriter’s exercise of its overallotment of 355,565 shares, at $6.75 per share. The net proceeds of the offering, after deducting the underwriter’s discounts and other offering expenses payable by the Company, was approximately $16.5 million. During 2018, options to purchase 144,947 shares of the Company’s common stock were exercised for 71,290 shares of common stock at exercise prices ranging from $3.48 to $5.64 by surrendering options and shares of common stock already owned . During 2017, options to purchase 56,969 shares of the Company’s common stock were exercised for 22,487 shares of common stock at exercise prices ranging from $3.48 to $4.45 by surrendering options and shares of common stock already owned. (b) Preferred Stock The Company has 10,000,000 shares of preferred stock authorized and none outstanding. These shares can become issuable upon an approved resolution by the board of directors and the filing of a Certificate of Designation with the state of Nevada. (c) Options, Restricted Stock, and Restricted Stock Units The Board of Directors or its Compensation Committee may issue options, restricted stock, and restricted stock units pursuant to employee stock incentive plans that have been approved by the Company's stockholders. (d) Warrants As of December 31, 2018 and 2017, the Company had no warrants outstanding to purchase shares of common stock. |
RIGHTS AGREEMENT
RIGHTS AGREEMENT | 12 Months Ended |
Dec. 31, 2018 | |
RIGHTS AGREEMENT [Abstract] | |
RIGHTS AGREEMENT | NOTE 10 — RIGHTS AGREEMENT: In March 2016, the Company entered into a Rights Agreement (the "Rights Agreement") with Action Stock Transfer Corp., as Rights Agent. The Rights Agreement expired on March 7, 2019. Pursuant to the Rights Agreement, the Company declared a dividend distribution of one preferred share purchase right (a "Right") for each outstanding share of common stock as of March 8, 2016. Rights Initially Not Exercisable. Separation and Distribution of Rights |
STOCK INCENTIVE PLANS
STOCK INCENTIVE PLANS | 12 Months Ended |
Dec. 31, 2018 | |
STOCK INCENTIVE PLANS [Abstract] | |
STOCK INCENTIVE PLANS | NOTE 11 — STOCK INCENTIVE PLANS: Effective June 3, 2008, the Company’s stockholders voted to approve the 2008 Stock Incentive Plan (“SIP”), with 625,000 shares of common stock available to be issued. At the Annual Stockholder Meeting on September 22, 2011 the Company’s stockholders voted to approve an increase to the shares of common stock issuable under the SIP by 125,000 to 750,000. Under the terms of the SIP, which expired during 2018, the Board of Directors or its Compensation Committee had the discretion to select the persons to whom awards were to be granted. Awards could be stock options, restricted stock and/or restricted stock units ("Equity Award Units"). The awards became vested at such times and under such conditions as determined by the Board or its Compensation Committee. Cumulatively through December 31, 2018, there were 508,889 options exercised, and at December 31, 2018, 99,132 options were outstanding and no Equity Award Units were available to be issued under the SIP. Effective June 19, 2014, the Company’s stockholders voted to approve the 2014 Stock Incentive Plan (“SIP14”), with 800,000 shares of common stock available to be issued. Under the terms of the SIP14, the Board or its Compensation Committee has the discretion to select the persons to whom awards are to be granted. Awards can be in the form of Equity Award Units. The awards become vested at such times and under such conditions as determined by the Board or its Compensation Committee. Cumulatively through December 31, 2018, there were 85,407 options exercised, and at December 31, 2018, 405,968 options were outstanding and 21,061 Equity Award Units were still available to be issued under the SIP14. During 2018, 266,839 shares of restricted stock and 20,725 restricted stock units were awarded under SIP14. The Company's results for the years ended December 31, 2018 and 2017 include stock-based compensation expense totaling $632,805 and $384,897, respectively. Such amounts have been included in the Consolidated Statements of Operations within cost of goods sold ($25,615 and $47,000, respectively), research and development ($78,831 and $89,400, respectively) and selling, general and administrative expenses ($528,360 and $248,497, respectively). Stock option compensation expense in the years ended December 31, 2018 and 2017 represents the estimated fair value of options outstanding which is being amortized on a straight-line basis over the requisite vesting period of the entire award. The weighted average estimated fair value of stock options granted in the years ended December 31, 2018 and 2017 were $3.76 and $2.77 per share, respectively. The fair value of options at the date of grant was estimated using the Black-Scholes option pricing model. The expected volatility is based upon historical volatility of the Company’s stock and other contributing factors. The expected term is based on the Company’s historical experience with similar type options. The weighted-average assumptions made in calculating the fair values of options are as follows for the respective years ended: December 31, 2018 December 31, 2017 Expected term (in years) 4.96 5.48 Expected volatility 39.91 % 43.31 % Expected dividend yield n/a n/a Risk-free interest rate 2.70 % 1.78 % The Company granted 93,750 new options during the year ended December 31, 2018. The following table provides stock option activity for the years ended December 31, 2018 and 2017: Number of Shares Weighted Average Exercise Price per Share Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at December 31, 2016 600,549 4.55 3.43 years $ 1,463,052 Granted 267,875 6.40 Exercised 56,969 4.19 100,018 Forfeited/expired/cancelled 785 5.56 Outstanding at December 31, 2017 810,670 5.18 3.69 years $ 2,477,853 Exercisable at December 31, 2017 371,295 4.44 2.62 years $ 1,409,440 Outstanding at December 31, 2017 810,670 $ 5.18 3.69 years $ 2,477,853 Granted 93,750 $ 9.80 352,220 Exercised 144,947 $ 4.83 523,327 Forfeited/expired/cancelled 47,505 $ 8.82 154,583 Outstanding at December 31, 2018 711,968 $ 5.62 3.33 years $ 687,364 Exercisable at December 31, 2018 396,799 $ 4.70 2.66 years $ 568,956 The following table summarizes information about stock options outstanding at December 31, 2018: Stock Options Outstanding Stock Options Exercisable Range of Exercise Prices Shares Outstanding Average Remaining Contract Life (Year) Weighted Average Exercise Price Aggregate Intrinsic Value Shares Exercisable Weighted Average Exercise Price Aggregate Intrinsic Value 1 to 2.79999 - - $ - $ - - $ - $ - 2.8 to 4.59999 304,343 1.90 3.45 672,896 254,343 3.46 560,711 4.6 to 6.39999 152,875 3.43 5.85 14,468 58,020 5.80 8,245 6.4 to 8.19999 207,875 5.05 7.31 - 75,041 7.21 - 8.2 to 12 46,875 4.60 11.45 - 9,375 11.45 - Total 711,968 3.33 $ 5.62 $ 687,364 396,779 $ 4.70 $ 568,956 As of December 31, 2018, there was $710,376 of net unrecognized compensation cost related to stock options that are not vested, which is expected to be recognized over a weighted average period of approximately 2.45 years. The total fair value of shares vested during the year ended December 31, 2018, was $553,000. The following table summarizes information about restricted stock and restricted stock units outstanding as of December 31, 2018: Number of Shares & Units Weighted Average Grant Date Fair Value Outstanding at December 31, 2017 - $ - Granted 287,564 9.65 Exercised - - Forfeited/expired/cancelled - - Outstanding at December 31, 2018 287,564 9.65 Exercisable at December 31, 2018 - $ - As of December 31, 2018, there was $1,688,746 of net unrecognized compensation cost related to restricted stock and restricted stock units that are not vested, which is expected to be recognized over a weighted average period of approximately 2.5 years. Stock based compensation cost related to restricted stock and restricted stock units recognized during the years ended December 31, 2018 and 2017 was $281,249 and $0, respectively. |
GEOGRAPHIC INFORMATION AND ECON
GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY | 12 Months Ended |
Dec. 31, 2018 | |
GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract] | |
GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY | NOTE 12 — GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY: The Company produces only one group of similar products known collectively as “rapid medical tests,” and it operates in a single business segment. Net product sales by geographic area are as follows: For the years ended December 31, 2018 December 31, 2017 Africa $ 8,605,306 $ 3,568,455 Asia 1,389,120 1,626,750 Europe & Middle East 2,172,031 1,763,274 Latin America 11,722,224 8,476,003 United States 2,852,339 3,887,820 $ 26,741,020 $ 19,322,302 Long-lived assets by geographic area are as follows: 2018 2017 Asia $ 466,185 $ 472,774 Europe & Middle East 123,752 - United States 2,283,983 1,436,458 $ 2,873,920 $ 1,909,232 |
COMMITMENTS, CONTINGENCIES AND
COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS | 12 Months Ended |
Dec. 31, 2018 | |
COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS [Abstract] | |
COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS | NOTE 13 — COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS: Employment Contracts: The Company has multi-year contracts with two key employees. The contracts call for salaries presently aggregating $770,000 per year, and they expire in March 2019 and March 2020. The following table is a schedule of future minimum salary commitments: 2019 $ 485,493 2020 85,000 Pension Plan: The Company has a 401(k) plan established for its employees whereby it matches 40% of the first 5% (or 2% of salary) that an employee contributes to the plan. Matching contribution expenses totaled $94,544 and $91,150 for the years ended December 31, 2018 and 2017, respectively. Obligations Under Operating Leases: The Company leases industrial space used for office, R&D and manufacturing facilities, currently with a monthly rent of $30,140. The current lease expires on April 30, 2019. The lease provides for annual increases of 2.5% percent each year starting May 1, 2016. In February of 2014, the Company entered into a lease for office and warehouse space, effective March 1, 2014, a short distance from its current facility currently with a monthly rent of $16,709. The space is used primarily for warehousing and provides for additional office space. The lease expires on April 30, 2020. The lease provides for annual increases of 3.0% percent each year starting March 1, 2016. The Company also leases office, warehouse, and manufacturing space in a single building in Kuala Lumpur, Malaysia persuant to two separate leases that each expire on April 30, 2020 and have an additional three year renewal option with combined monthly rent of approximately $5,400. The Company also leases space in Germany for offices, manufacturing, and center of excellence for optical technology. The lease will automatically renew annually on May 31. The monthly cost is estimated at $13,445 with yearly increases of 2%. The following is a schedule of future minimum rental commitments for the years ending December 31, 2019 $ 384,308 2020 88,576 2021 - $ 472,884 Rent expense was $653,155 and $586,730 for the years ended December 31, 2018 and 2017, respectively. Economic Dependency: Customers are considered major customers when net sales exceed 10% of the Company's total net sales for period or outstanding trade receivables exceed 10% of accounts receivable. The Company had the following major customers for the respective periods: For the years ended Accounts Receivable December 31, 2018 December 31, 2017 December 31, 2018 December 31, 2017 Sales % of Sales Sales % of Sales Customer 1 $ 11,171,174 42 % $ 8,065,217 42 % $ 3,499,340 $ - Customer 2 4,346,640 16 % - - % 1,033,824 - The following table delineates purchases the Company had with vendors in excess of 10% of total purchases for the periods indicated: For the years ended Accounts Payable December 31, 2018 December 31, 2017 December 31, 2018 December 31, 2017 Purchases % of Purc. Purchases % of Purc. Vendor 1 $ * * $ * * $ * $ * Vendor 2 * * 746,868 12 % * * Vendor 3 * * 849,966 14 % 164,312 * Vendor 4 1,646,614 16 % 884,698 14 % * * In the tables above, an asterisk (*) indicates that purchases from the vendor did not exceed 10% for the period indicated. The Company purchases materials pursuant to intellectual property rights agreements that are important components in its products. Management believes that other suppliers could provide similar materials on comparable terms. A change in suppliers, however, could cause a delay in manufacturing and a possible loss of sales, which could adversely affect operating results. Litigation: From time to time, the Company is involved in certain legal actions arising in the ordinary course of business. The outcomes of such actions, either individually or in the aggregate, are not expected to have a material adverse effect on the Company’s future financial position or results of operations. |
NOTE PAYABLE
NOTE PAYABLE | 12 Months Ended |
Dec. 31, 2018 | |
NOTE PAYABLE [Abstract] | |
NOTE PAYABLE | NOTE 14 — NOTE PAYABLE: In September 2017, the Company entered into an agreement with an equipment vendor to purchase automated assembly equipment for approximately $660,000. The terms call for prepayments of 30% down, 60% at time of factory acceptance testing and 10% after delivery. The vendor agreed to lend the Company 15%, 40%, and 10% of each originally scheduled payment, respectively. The Company will pay interest at an annual rate of 12% until delivery. Beginning in September 2018, the Company began making monthly payments of principal and interest of approximately $20,150, at an annual rate of 12% over a twenty-four month period. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2018 | |
SUBSEQUENT EVENTS [Abstract] | |
SUBSEQUENT EVENTS | NOTE 15 — SUBSEQUENT EVENTS: On February 5, 2019, the Company entered into a commercial real estate lease for a new corporate headquarters comprised of 70,000 square feet of office, research and development, and warehouse space in Hauppauge, New York. The lease has an initial term of eleven years that can be extended, at the Company’s option, for two additional terms of five years each. Rent under the lease, which is payable in monthly installments, totals approximately $900,000 for the initial year and then increases by approximately three percent each succeeding year. Upon lease inception, the Company provided a security deposit and paid four months base rent that together totaled approximately $450,000. The base rent which will be deducted against the rent due following a nine-month free rent period. On February 5, 2019, the Company also entered into an agreement of sublease with an affiliate of the Hauppauge, NY facility landlord to sublet the Company’s warehouse space and supplemental administrative office facility in Holbrook, New York. The sublease has a term that will (a) commence on the later of March 18, 2019 and the date the Company vacates the premises and (b) terminate on April 29, 2020, which is immediately prior to the termination of the Company’s lease for the facility. The sublessee will pay the Company 50% of the Company’s rent and additional rent payments, which will total approximately $100,000 per year during the term of the sublease. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Principles of Consolidation | (a) Principles of Consolidation: The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany transactions and balances are eliminated in consolidation. Certain amounts from prior years have been reclassified to conform to the 2018 presentation. |
Use of Estimates | (b) Use of Estimates: The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make assumptions and estimates that affect the amounts reported in the consolidated financial statements and accompanying notes. Judgments and estimates of uncertainties are required in applying the Company’s accounting policies in certain areas. Generally, matters subject to estimation and judgment include accounts receivable realization, inventory obsolescence, asset impairments, recognition of revenue persuant to milestones, useful lives of intangible and fixed assets, stock-based compensation, and deferred tax asset valuation allowances. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be based upon amounts that differ from those estimates. |
Fair Value of Financial Instruments | The carrying value for cash and cash equivalents, accounts receivable, and accounts payable, approximate fair value due to the immediate or short-term maturity of these financial instruments. Included in cash and cash equivalents is $4.7 million and $2.1 million as of December 31, 2018 and 2017, respectively, of money market funds that are Level 1 fair value measurements under the hierarchy. The fair value of the Company's notes payable approximates the recorded value as the rate is based upon the current rates offered to the Company for similar financial instruments. Fair value measurements of all financial assets and liabilities that are being measured and reported on a fair value basis are required to be classified and disclosed in one of the following three categories: Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). |
Cash and Cash Equivalents | (d) Cash and Cash Equivalents: Cash and cash equivalents are defined as short-term, highly liquid investments with original maturities of three months or less. |
Concentrations of Credit Risk | (e) Concentrations of Credit Risk: Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of temporary cash investments and trade receivables. The Company places its temporary cash instruments with well-known financial institutions and, at times, may maintain balances in excess of the FDIC insurance limit. The Company monitors the credit ratings of the financial institutions to mitigate this risk. Concentration of credit risk with respect to trade receivables is principally mitigated by the Company’s ability to obtain letters of credit from certain foreign customers and its diverse customer base, both in number of customers and geographic locations. |
Inventories | (f) Inventories: Inventories, consisting of material, labor and manufacturing overhead, are stated at the lower of cost and net realizable value. Cost is determined on the first-in, first-out method. The Company’s policy is to periodically evaluate the market value of the inventory and the stage of product life cycle, and record a write-down for any inventory considered slow moving or obsolete. |
Fixed Assets | (g) Fixed Assets: Fixed assets are stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets, which range from three to seven years. Leasehold improvements are amortized over the useful life of the asset or the lease term, whichever is shorter. Deposits paid for fixed assets are capitalized and not depreciated until the related asset is placed in service. |
License Agreements | (h) License Agreements: The Company records up-front payments related to sublicense agreements as prepaids and amortizes them over their respective economic life. As of December 31, 2018 and 2017, total prepaids were $100,000 and $100,000, respectively. Amortization expenses for the licenses above for the years ended December 31, 2018, and 2017 were $0, and $137,500, respectively. |
Valuation of Long-Lived Assets and Intangible Assets | (i) Valuation of Long-Lived Assets and Intangible Assets: Long-lived assets to be held and used are analyzed for impairment whenever events or changes in circumstances indicate that the related carrying amounts may not be recoverable. The Company evaluates at each balance sheet date whether events and circumstances have occurred that indicate possible impairment. If there are indications of impairment, the Company uses future undiscounted cash flows of the related asset or asset grouping over the remaining life in measuring whether the assets are recoverable. In the event such cash flows are not expected to be sufficient to recover the recorded asset values, the assets are written down to their estimated fair value. No impairment of long-lived tangible and intangible assets was recorded for the years ended December 31, 2018 and 2017. |
Revenue Recognition | (j) Revenue Recognition: In May 2014, the Financial Accounting Standards Board (“FASB”) issued converged guidance on recognizing revenue in contracts with customers, Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers The new revenue standards became effective for the Company on January 1, 2018 and were adopted using the modified retrospective method. The adoption of the new revenue standards as of January 1, 2018 did not change the Company’s revenue recognition as its revenues continue to be recognized when the customer takes control of its product. As the Company did not identify any material accounting changes that impacted the amount of reported revenues with respect to its product revenue, license and royalty revenue, and R&D, milestone and grant revenues, no adjustment to retained earnings was required upon adoption. The Company adopted the standards to contracts that were not completed at the date of initial application (January 1, 2018). Under the new revenue standards, the Company recognizes revenues when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. The Company recognizes revenues following the five-step model prescribed under ASU No. 2014-09: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) the Company satisfies the performance obligation. Product Revenues Revenues from product sales are recognized and commissions are accrued when the customer obtains control of the Company’s product, which occurs at a point in time, typically upon tendering to the customer. The Company expenses incremental costs of obtaining a contract as and when incurred because the expected amortization period of the asset that it would have recognized is one year or less or the amount is immaterial. Freight and distribution activities on products are performed after the customer obtains control of the goods. The Company has made an accounting policy election to account for shipping and handling activities that occur either when or after goods are tendered to the customer as a fulfillment activity, and therefore recognizes freight and distribution expenses in Cost of Product Sales. The Company’s payment terms vary by the type and location of the Company’s customer and products or services offered. Payment terms differ by jurisdiction and customer but payment is generally required in a term ranging from 30 to 60 days from date of shipment or satisfaction of the performance obligation. Reserves for Discounts and Allowances Revenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with the Company’s customers. The Company’s process for estimating reserves established for these variable consideration components does not differ materially from its historical practices. Product revenue reserves, which are classified as a reduction in product revenues, are generally related to discounts. Estimates of variable consideration and the determination of whether to include estimated amounts in the transaction price are based on all information (historical, current and forecasted) that is reasonably available to the Company, taking into consideration the type of customer, the type of transaction and the specific facts and circumstances of each arrangement. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from the Company’s estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment. Royalty Revenues The Company receives royalty revenues on sales by its licensees of products covered under patents that it owns. The Company does not have future performance obligations under these license arrangements. The Company records these revenues based on estimates of the sales that occurred during the relevant period as a component of license and royalty revenues. The relevant period estimates of sales are based on interim data provided by licensees and analysis of historical royalties that have been paid to the Company, adjusted for any changes in facts and circumstances, as appropriate. Differences between actual and estimated royalty revenues are adjusted for in the period in which they become known, typically the following quarter. Historically, adjustments have not been material when compared to actual amounts paid by licensees. R&D and grant revenue All such contracts are evaluated under the five-step model described above. For certain contracts that represent grants where the funder does not meet the definition of a customer, the Company recognizes revenue when earned in accordance with ASC 958. Such contracts are further described under Disaggregation of Revenue Disaggregation of Revenue The following tables disaggregate Total Revenues for the year ended December 31, 2018: Exchange Transactions Non-Exchange Transactions Total Net product sales $ 26,741,020 $ - $ 26,741,020 License and royalty revenue 948,773 - 948,773 R&D, milestone and grant revenue 2,687,210 3,032,248 5,719,458 $ 30,377,003 $ 3,032,248 $ 33,409,251 Exchange transactions are recognized in accordance with ASC 606, while non-exchange transactions are recognized in accordance with ASC 985. Total Africa $ 8,605,306 Asia 1,389,120 Europe & Middle East 4,726,691 Latin America 11,722,224 United States 6,965,910 $ 33,409,251 Contract Liabilities Deferred revenue relates to payments received in advance of performance under the contract. Deferred revenue is recognized as revenue as (or when) the Company performs under the contract. At December 31, 2017, the Company reported $50,000 in deferred revenue of which $50,000 was earned and recognized as R&D, milestone and grant revenue during the year ended December 31, 2018. At December 31, 2018, the Company reported $422,905 in deferred revenue which is expected to be recognized during the first quarter of 2019. In April 2017, the Company entered into a $1.0 million agreement with FIND to develop a simple, point-of-care fever panel assay that can identify multiple life-threatening acute febrile illnesses common in the Asia Pacific region. The Company earned $0.1 million and $0.9 million for the year ended December 31, 2018, and from inception through December 31, 2018, respectively as R&D, milestone and grant revenue in the Company’s Consolidated Statements of Operations. In August 2016, the Company was awarded a grant of $5.9 million from BARDA, which is part of the U.S. Department of Health And Human Resources to develop a rapid Zika virus assay. The Company earned $2.6 million and $5.3 million for the year ended December 31, 2018 and from inception through December 31, 2018, respectively, as R&D, milestone and grant revenue in the Company’s Consolidated Statements of Operations. In September 2016, the Company was awarded a $0.7 million contract from the USDA to develop a Bovid TB assay. The Company earned $0.2 million and $0.5 million for the year ended December 31, 2018 and from inception through December 31, 2018, respectively, as R&D, milestone and grant revenue in the Company’s Consolidated Statements of Operations. |
Research and Development | (k) Research and Development: Research and development (R&D) costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. |
Stock-Based Compensation | (l) Stock-Based Compensation: The fair value of restricted stock and restricted stock unit awards are their fair value on the date of grant. Stock-based compensation expense for stock options is calculated using the Black-Scholes valuation model based on awards ultimately expected to vest together with the fair value of restricted stock and restricted stock unit awards, are, reduced for actual forfeitures, and, expensed on a straight-line basis over the requisite service period of the grant. During 2017, the Company adopted ASU 2016-09, "Improvements to Employee Share-Based Payment Accounting". |
Income Taxes | (m) I ncome Taxes: The Company accounts for income taxes under an asset and liability approach that recognizes deferred tax assets and liabilities based on the difference between the financial statement carrying amounts and the tax bases of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. The Company follows a more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. The guidance relates to, among other things, classification, accounting for interest and penalties associated with tax positions, and disclosure requirements. Any interest and penalties accrued related to uncertain tax positions are recorded in tax expense. The Company assesses the realizability of its net deferred tax assets on an annual basis. If, after considering all relevant positive and negative evidence, it is more likely than not that some portion or all of the net deferred tax assets will not be realized, the Company will reduce the net deferred tax assets by a valuation allowance. The realization of net deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of net operating loss carryforwards. |
Loss Per Share | (n) Loss Per Share: Basic loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period including outstanding restricted stock that by its terms is includible in the calculation. Diluted loss per share for the years ended December 31, 2018, and 2017 reflects the potential dilution from the exercise or conversion of other securities into common stock, if dilutive. There were 711,968, and 810,670 options outstanding as of December 31, 2018 and 2017, respectively, which were not included in the calculation of diluted income per share for the years ended because their effect would have been anti-dilutive. |
Goodwill and Intangible Assets | (o) Goodwill and Intangible Assets: Goodwill represents the excess of the purchase price the Company paid over the fair value of the net tangible and identifiable intangible assets acquired in the Company’s acquisition of opTricon in November 2018 and CDM in January 2017. Goodwill is not amortized but rather is tested annually as of the first day of the fiscal fourth quarter, or sooner if the Company believes that indicators of impairment exist. The Company makes a qualitative evaluation about the likelihood of goodwill impairment, which is based on a number of applicable factors. If the Company concludes that it is more likely than not that the carrying value of the applicable reporting unit is greater than its fair value, then it would recognize an impairment charge for the amount by which the carrying value exceeds the reporting unit’s fair value, provided the impairment charge does not exceed the total amount of goodwill allocated to the reporting unit. For the year ended December 31, 2018 and 2017, there was no impairment of goodwill and other intangible assets. Following is a table that reflects changes in Goodwill: Beginning balance 1/1/18 $ 1,666,610 Acquisition of opTricon 3,337,000 Changes in foreign currency exchange rate (20,483 ) Balance at December 31, 2018 $ 4,983,127 Intangible assets consist of the following at: Weighted Average Remaining Life December 31, 2018 December 31, 2017 Cost Accumulated Amortization Net Book Value Cost Accumulated Amortization Net Book Value Intellectual property 10 $ 1,089,688 $ 173,633 $ 916,055 $ 886,872 $ 88,687 $ 798,185 Developed technology 7 1,910,315 - 1,910,315 - - - Customer contracts/relationships 8 1,121,600 151,929 969,671 776,013 77,601 698,412 Order backlog - 217,187 217,187 - 221,867 221,867 - Trade names 9 108,521 19,731 88,790 110,859 10,079 100,780 $ 4,447,311 $ 562,480 $ 3,884,831 $ 1,995,611 $ 398,234 $ 1,597,377 Amortization expense for the year ended December 31, 2018 and 2017 was $233,734 and $398,234, respectively, and is recorded within Selling, General and Administrative expenses. Amortization expense, subject to changes in currency exchange rates, is expected to be $496,512 per year from 2019 through 2023, and total $1,402,271 for all of the years thereafter. |
Allowance for Doubtful Accounts | (p) Allowance for Doubtful Accounts: The Company records allowances for doubtful accounts for the estimated probable losses on uncollectible accounts receivable. The allowance is based upon the credit worthiness of the Company’s customers, the Company’s historical experience, the age of the receivable and current market and economic conditions. Receivables are written off against these allowances in the period they are determined to be uncollectible. |
Acquisition Costs | (q) Acquisition Costs: Acquisition costs include period expenses, primarily professional services, related to acquisition activities. |
Foreign Currency Translation | (r) Foreign Currency Translation: The functional currency of a foreign subsidiary is the local currency. Assets and liabilities of foreign subsidiaries that use a currency other than U.S. dollars as their functional currency are translated to U.S. dollars at end of period currency exchange rates. The consolidated statements of operations of foreign subsidiaries are translated to U.S. dollars at average period currency exchange rates. The effect of translation for foreign subsidiaries is generally reported in Other comprehensive income. Foreign transaction gains are immaterial. |
Recent Accounting Pronouncements Affecting the Company | (s) Recent Accounting Pronouncements Affecting the Company: In May 2014, the Financial Accounting Standards Board (“FASB”) issued converged guidance on recognizing revenue in contracts with customers, Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers The Company has completed its evaluation of the new standard and assessed the impact of adoption on its consolidated financial statements. The Company reviewed significant open contracts with customers for each revenue stream, and based on its evaluation, revenue recognition under the new standard did not have a material impact on the Company’s consolidated financial statements because: i) product sales revenue is recognized when control of the goods is transferred to the customer (i.e., the date of shipment, which is consistent under ASC 605), and ii) R&D and grant revenue historically did not constitute exchange transactions and therefore the new standard did not apply to such revenue upon adoption. The Company also assessed its control framework as a result of adopting the new standard and noted minimal, insignificant changes to its systems and other controls processes. The new standard permitted two adoption methods under ASU 2014-09. The guidance could be adopted through either retrospective application to all periods presented in the consolidated financial statements (full retrospective) or through a cumulative effect adjustment to retained earnings at the effective date (modified retrospective). The Company adopted the new standard effective January 1, 2018 using the modified retrospective transition method. Under that method, the Company applied the rules to all contracts existing as of January 1, 2018. The cumulative effect was not material. In November 2015, the FASB issued ASU 2015-17, Income Taxes (Topic 740) Balance Sheet Classification of Deferred Assets In Leases Codification Improvements to Topic 842, Leases Leases (Topic 842) Targeted Improvements The Company will adopt Topic 842 on January 1, 2019 under the optional transition method and elect the short-term lease exception and available practical expedients. Under the transition method, the Company will not adjust its comparative period financial information or make the new required lease disclosures for periods before the effective date. Upon adoption, the Company expects the consolidated balance sheet to include a right of use asset and liability related to substantially all of the Company’s lease arrangements. While the Company continues to evaluate the effects of adopting the provisions of Topic 842, including the impact that this new guidance will have on its processes and controls, the Company expects most existing operating lease commitments will be recognized as operating lease liabilities and right-of-use assets upon adoption. The adoption is not expected to be material to the consolidated financial statements, and based on the Company’s ongoing assessment, is expected to increase total assets and total liabilities by no more than approximately $1.5 million, on a discounted basis. Please In March 2016, the FASB issued authoritative guidance under ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments The Company adopted ASU 2016-15 in the first quarter of 2018. In January 2017, the FASB issued ASU 2017-04, Intangibles-Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting The Company adopted ASU 2017-09 in the first quarter of 2018. In July 2018, the FASB issued ASU 2018-08 N ot-for-Profit Entities (Topic 958): Clarifying the Scope and the Accounting Guidance for Contributions Received and Contributions Made to clarify the accounting guidance related to contributions made or received. This guidance primarily affects not-for-profit entities, although it also applies to businesses to the extent that they make or receive contributions, including grants. ASU 2018-08 clarifies and improves the scope and accounting guidance for both contributions received and made in order to assist entities in evaluating if those transactions should be accounted for as contributions under the scope of Topic 958, or as an exchange transaction subject to other guidance. Public entities are required to apply the amendments on contributions received and contributions made to annual periods beginning after June 15, 2018, and December 15, 2018, respectively, each including interim periods within those annual periods. Early adoption is permitted, and the Company adopted ASU 2018-08 effective as of January 1, 2018. The impact of adoption was immaterial. |
ACQUISITIONS (Tables)
ACQUISITIONS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Business Acquisition [Line Items] | |
Unaudited Pro forma Operating Results | The following represents unaudited pro forma operating results for the year ended December 31, 2018 as if the operations of opTricon had been included in the Company’s Consolidated Statements of Operations as of January 1, 2018: Proforma December 31, 2018 Total revenues $ 35,442,806 Net loss (8,394,074 ) Net loss per common share $ (0.58 ) Diluted net loss per common share $ (0.58 ) |
op Tricon [Member] | |
Business Acquisition [Line Items] | |
Fair Values of Assets Acquired and Liabilities Assumed | The acquisition was accounted for using the purchase method of accounting. The following table summarizes the preliminary allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed on the closing date of November 6, 2018: Amount Net current assets $ 404,204 Property, plant and equipment 125,000 Goodwill 3,337,000 Deferred tax liability (635,000 ) Other intangible assets (estimated useful life): Developed technology (7 years) 1,900,000 Customer contracts / relationships (10 years) 360,000 Total consideration $ 5,491,204 |
RVR Diagnostics Sdn Bhd [Member] | |
Business Acquisition [Line Items] | |
Fair Values of Assets Acquired and Liabilities Assumed | The acquisition was accounted for using the purchase method of accounting. The following table summarizes the allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed on the closing date of January 9, 2017: Amount Property, plant and equipment $ 235,141 Goodwill 1,651,361 Deferred tax liability (307,636 ) Contingent consideration (148,000 ) Other intangible assets (estimated useful life): Intellectual property (10 years) 800,000 Customer contracts / relationships (10 years) 700,000 Order backlog (3 months) 200,134 Trade name (11 years) 100,000 Total consideration $ 3,231,000 |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Disaggregation of Revenue | The following tables disaggregate Total Revenues for the year ended December 31, 2018: Exchange Transactions Non-Exchange Transactions Total Net product sales $ 26,741,020 $ - $ 26,741,020 License and royalty revenue 948,773 - 948,773 R&D, milestone and grant revenue 2,687,210 3,032,248 5,719,458 $ 30,377,003 $ 3,032,248 $ 33,409,251 Exchange transactions are recognized in accordance with ASC 606, while non-exchange transactions are recognized in accordance with ASC 985. Total Africa $ 8,605,306 Asia 1,389,120 Europe & Middle East 4,726,691 Latin America 11,722,224 United States 6,965,910 $ 33,409,251 |
Changes in Goodwill | Following is a table that reflects changes in Goodwill: Beginning balance 1/1/18 $ 1,666,610 Acquisition of opTricon 3,337,000 Changes in foreign currency exchange rate (20,483 ) Balance at December 31, 2018 $ 4,983,127 |
Intangible Assets | Intangible assets consist of the following at: Weighted Average Remaining Life December 31, 2018 December 31, 2017 Cost Accumulated Amortization Net Book Value Cost Accumulated Amortization Net Book Value Intellectual property 10 $ 1,089,688 $ 173,633 $ 916,055 $ 886,872 $ 88,687 $ 798,185 Developed technology 7 1,910,315 - 1,910,315 - - - Customer contracts/relationships 8 1,121,600 151,929 969,671 776,013 77,601 698,412 Order backlog - 217,187 217,187 - 221,867 221,867 - Trade names 9 108,521 19,731 88,790 110,859 10,079 100,780 $ 4,447,311 $ 562,480 $ 3,884,831 $ 1,995,611 $ 398,234 $ 1,597,377 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
INVENTORIES [Abstract] | |
Inventories | Inventories consist of the following at: December 31, 2018 December 31, 2017 Raw Materials $ 2,803,677 $ 1,767,684 Work in Process 263,043 286,413 Finished Goods 4,784,502 2,369,521 $ 7,851,222 $ 4,423,618 |
FIXED ASSETS (Tables)
FIXED ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
FIXED ASSETS [Abstract] | |
Fixed Assets | Fixed assets consist of the following at: December 31, 2018 December 31, 2017 Machinery and Equipment $ 6,070,137 $ 4,582,759 Furniture and Fixtures 35,287 449,548 Computer Equipment 435,348 422,946 Leasehold Improvements 2,334,512 2,258,779 Enterprise Business Systems 462,420 - Less: Accumulated Depreciation and Amortization (6,463,784 ) (5,804,800 ) $ 2,873,920 $ 1,909,232 |
ACCOUNTS PAYABLE AND ACCRUED _2
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract] | |
Accounts Payable and Accrued Liabilities | Accounts payable and accrued liabilities consist of the following at: December 31, 2018 December 31, 2017 Accounts Payable - suppliers $ 3,622,765 $ 1,494,759 Accrued Commissions 588,131 126,827 Accrued Royalties / license fees 279,213 429,297 Accrued Payroll 48,867 187,305 Accrued Vacation 264,789 309,767 Accrued Bonuses 494,318 282,500 Accrued Expenses - Other 590,598 215,848 $ 5,888,681 $ 3,046,303 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
INCOME TAXES [Abstract] | |
(Benefit) Provision for Income Taxes | The (benefit from) provision for income taxes for the years ended December 31, 2018 and 2017 is comprised of the following: 2018 2017 Current Federal $ - $ (97,339 ) State 10,914 9,034 Foreign - - Total current (benefit) provision 10,914 (88,305 ) Deferred Federal - - State - - Foreign (78,435 ) - Total deferred (benefit) provision (78,435 ) - Total (benefit) provision $ (67,521 ) $ (88,305 ) |
Deferred Tax Assets and Liabilities | 2018 2017 Inventory reserves $ 204,206 $ 244,158 Accrued expenses 175,168 102,332 Net operating loss carry-forwards 7,122,576 5,800,144 Research and development credit 1,696,870 1,918,137 Stock-based compensation 215,797 167,522 Depreciation 139,362 91,258 Total deferred tax assets 9,553,979 8,323,551 Intangibles (968,849 ) (341,042 ) Total deferred tax liabilities (968,849 ) (341,042 ) Net deferred tax assets before valuation allowance 8,585,130 7,982,509 Less valuation allowances (9,477,438 ) (8,323,551 ) Net noncurrent deferred tax liabilities $ (892,308 ) $ (341,042 ) |
Components of (Loss) Before Income Taxes | The components of (loss) before income taxes consisted of the following: Year Ending December 31, 2018 2017 United States operations $ (7,137,428 ) $ (6,054,002 ) International operations (795,742 ) (406,063 ) (Loss) before taxes $ (7,933,170 ) $ (6,460,065 ) |
Reconciliation of Federal Statutory Rate to Effective Rate Applicable to Loss Before Income Taxes | A reconciliation of the Federal statutory rate to the effective rate applicable to loss before income taxes is as follows: Year Ending December 31, 2018 2017 Federal income tax at statutory rates 21.00 % 34.00 % State income taxes, net of federal benefit (.10 )% (0.09 )% Nondeductible expenses (1.58 )% (1.04 )% Foreign rate differential .36 % (2.14 )% Change in valuation allowance (18.44 )% (99.41 )% Impact of Tax Act on valuation allowance - % 60.48 % AMT refund under Tax Act - % 1.51 % Tax credits - % 7.07 % Other (.39 )% 0.99 % Income tax benefit .85 % 1.37 % |
STOCK INCENTIVE PLANS (Tables)
STOCK INCENTIVE PLANS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
STOCK INCENTIVE PLANS [Abstract] | |
Assumptions Made in Calculating Fair Values of Options | The weighted-average assumptions made in calculating the fair values of options are as follows for the respective years ended: December 31, 2018 December 31, 2017 Expected term (in years) 4.96 5.48 Expected volatility 39.91 % 43.31 % Expected dividend yield n/a n/a Risk-free interest rate 2.70 % 1.78 % |
Stock Option Activity | The following table provides stock option activity for the years ended December 31, 2018 and 2017: Number of Shares Weighted Average Exercise Price per Share Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at December 31, 2016 600,549 4.55 3.43 years $ 1,463,052 Granted 267,875 6.40 Exercised 56,969 4.19 100,018 Forfeited/expired/cancelled 785 5.56 Outstanding at December 31, 2017 810,670 5.18 3.69 years $ 2,477,853 Exercisable at December 31, 2017 371,295 4.44 2.62 years $ 1,409,440 Outstanding at December 31, 2017 810,670 $ 5.18 3.69 years $ 2,477,853 Granted 93,750 $ 9.80 352,220 Exercised 144,947 $ 4.83 523,327 Forfeited/expired/cancelled 47,505 $ 8.82 154,583 Outstanding at December 31, 2018 711,968 $ 5.62 3.33 years $ 687,364 Exercisable at December 31, 2018 396,799 $ 4.70 2.66 years $ 568,956 |
Stock Options Outstanding | The following table summarizes information about stock options outstanding at December 31, 2018: Stock Options Outstanding Stock Options Exercisable Range of Exercise Prices Shares Outstanding Average Remaining Contract Life (Year) Weighted Average Exercise Price Aggregate Intrinsic Value Shares Exercisable Weighted Average Exercise Price Aggregate Intrinsic Value 1 to 2.79999 - - $ - $ - - $ - $ - 2.8 to 4.59999 304,343 1.90 3.45 672,896 254,343 3.46 560,711 4.6 to 6.39999 152,875 3.43 5.85 14,468 58,020 5.80 8,245 6.4 to 8.19999 207,875 5.05 7.31 - 75,041 7.21 - 8.2 to 12 46,875 4.60 11.45 - 9,375 11.45 - Total 711,968 3.33 $ 5.62 $ 687,364 396,779 $ 4.70 $ 568,956 |
Summary of Restricted Stock and Restricted Stock Units Outstanding | The following table summarizes information about restricted stock and restricted stock units outstanding as of December 31, 2018: Number of Shares & Units Weighted Average Grant Date Fair Value Outstanding at December 31, 2017 - $ - Granted 287,564 9.65 Exercised - - Forfeited/expired/cancelled - - Outstanding at December 31, 2018 287,564 9.65 Exercisable at December 31, 2018 - $ - |
GEOGRAPHIC INFORMATION AND EC_2
GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract] | |
Net Product Sales by Geographic Area | The Company produces only one group of similar products known collectively as “rapid medical tests,” and it operates in a single business segment. Net product sales by geographic area are as follows: For the years ended December 31, 2018 December 31, 2017 Africa $ 8,605,306 $ 3,568,455 Asia 1,389,120 1,626,750 Europe & Middle East 2,172,031 1,763,274 Latin America 11,722,224 8,476,003 United States 2,852,339 3,887,820 $ 26,741,020 $ 19,322,302 |
Long-lived Assets by Geographic Area | Long-lived assets by geographic area are as follows: 2018 2017 Asia $ 466,185 $ 472,774 Europe & Middle East 123,752 - United States 2,283,983 1,436,458 $ 2,873,920 $ 1,909,232 |
COMMITMENTS, CONTINGENCIES AN_2
COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS [Abstract] | |
Future Minimum Salary Commitment | The following table is a schedule of future minimum salary commitments: 2019 $ 485,493 2020 85,000 |
Future Minimum Rental Commitments | The following is a schedule of future minimum rental commitments for the years ending December 31, 2019 $ 384,308 2020 88,576 2021 - $ 472,884 |
Customer and Purchase Concentration Risks | Customers are considered major customers when net sales exceed 10% of the Company's total net sales for period or outstanding trade receivables exceed 10% of accounts receivable. The Company had the following major customers for the respective periods: For the years ended Accounts Receivable December 31, 2018 December 31, 2017 December 31, 2018 December 31, 2017 Sales % of Sales Sales % of Sales Customer 1 $ 11,171,174 42 % $ 8,065,217 42 % $ 3,499,340 $ - Customer 2 4,346,640 16 % - - % 1,033,824 - The following table delineates purchases the Company had with vendors in excess of 10% of total purchases for the periods indicated: For the years ended Accounts Payable December 31, 2018 December 31, 2017 December 31, 2018 December 31, 2017 Purchases % of Purc. Purchases % of Purc. Vendor 1 $ * * $ * * $ * $ * Vendor 2 * * 746,868 12 % * * Vendor 3 * * 849,966 14 % 164,312 * Vendor 4 1,646,614 16 % 884,698 14 % * * In the tables above, an asterisk (*) indicates that purchases from the vendor did not exceed 10% for the period indicated. |
ACQUISITIONS, opTricon (Details
ACQUISITIONS, opTricon (Details) - USD ($) | Nov. 06, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Business Combination, Consideration Transferred [Abstract] | |||
Acquisition costs | $ 337,645 | $ 58,076 | |
Fair values of Assets Acquired and Liabilities Assumed [Abstract] | |||
Goodwill | 4,983,127 | $ 1,666,610 | |
Unaudited Pro Forma Operating Results [Abstract] | |||
Total revenue | 35,442,806 | ||
Net loss | $ (8,394,074) | ||
Net loss per common share (in dollars per share) | $ (0.58) | ||
Diluted net loss per common share (in dollars per share) | $ (0.58) | ||
op Tricon [Member] | |||
Business Combination, Consideration Transferred [Abstract] | |||
Acquisition costs | $ 337,645 | ||
Fair values of Assets Acquired and Liabilities Assumed [Abstract] | |||
Net current assets | 404,204 | ||
Property, plant and equipment | 125,000 | ||
Goodwill | 3,337,000 | ||
Deferred tax liability | (635,000) | ||
Other intangible assets (estimated useful life): | |||
Other intangible assets | 2,260,000 | ||
Total consideration | 5,491,204 | ||
Unaudited Pro Forma Operating Results [Abstract] | |||
Total revenue | $ 2,214,000 | ||
Net loss | 213,000 | ||
Amortization of Intangible Assets | $ 351,000 | ||
op Tricon [Member] | Developed Technology [Member] | |||
Other intangible assets (estimated useful life): | |||
Other intangible assets | $ 1,900,000 | ||
Weighted average useful life | 7 years | ||
op Tricon [Member] | Customer Contracts / Relationships [Member] | |||
Other intangible assets (estimated useful life): | |||
Other intangible assets | $ 360,000 | ||
Weighted average useful life | 10 years |
ACQUISITIONS, RVR Diagnostics (
ACQUISITIONS, RVR Diagnostics (Details) - USD ($) | Jan. 09, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Business Combination, Consideration Transferred [Abstract] | |||
Deposit for investments | $ 0 | $ 850,000 | |
Fair values of Assets Acquired and Liabilities Assumed [Abstract] | |||
Goodwill | 4,983,127 | 1,666,610 | |
Other intangible assets (estimated useful life): | |||
Total revenue | 35,442,806 | ||
Net loss | $ (8,394,074) | ||
RVR Diagnostics Sdn Bhd [Member] | |||
Business Combination, Consideration Transferred [Abstract] | |||
Cash payment | $ 1,400,000 | ||
Deposit for investments | $ 550,000 | ||
Shares issued (in shares) | 269,236 | ||
Shares issued, value | $ 1,683,000 | ||
Shares held back (in shares) | 7,277 | ||
Business acquisition transaction costs | 25,000 | ||
Fair values of Assets Acquired and Liabilities Assumed [Abstract] | |||
Property, plant and equipment | $ 235,141 | ||
Goodwill | 1,651,361 | ||
Deferred tax liability | (307,636) | ||
Contingent consideration | (148,000) | ||
Other intangible assets (estimated useful life): | |||
Other intangible assets | 1,800,000 | ||
Total consideration | 3,231,000 | ||
Total revenue | 1,465,000 | ||
Net loss | $ (406,000) | ||
RVR Diagnostics Sdn Bhd [Member] | Intellectual Property [Member] | |||
Other intangible assets (estimated useful life): | |||
Other intangible assets | 800,000 | ||
Weighted average useful life | 10 years | ||
RVR Diagnostics Sdn Bhd [Member] | Customer Contracts / Relationships [Member] | |||
Other intangible assets (estimated useful life): | |||
Other intangible assets | 700,000 | ||
Weighted average useful life | 10 years | ||
RVR Diagnostics Sdn Bhd [Member] | Order Backlog [Member] | |||
Other intangible assets (estimated useful life): | |||
Other intangible assets | 200,134 | ||
Weighted average useful life | 3 months | ||
RVR Diagnostics Sdn Bhd [Member] | Trade Name [Member] | |||
Other intangible assets (estimated useful life): | |||
Other intangible assets | $ 100,000 | ||
Weighted average useful life | 11 years |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Part 1 (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Apr. 30, 2017 | Sep. 30, 2016 | Aug. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash and Cash Equivalents [Abstract] | ||||||
Cash and cash equivalents | $ 12,524,551 | $ 3,790,302 | $ 10,554,464 | |||
License Agreements [Abstract] | ||||||
Prepaid payments for license agreements | 100,000 | 100,000 | ||||
Amortization expenses | 0 | 137,500 | ||||
Valuation of Long-Lived Assets and Intangible Assets [Abstract] | ||||||
Goodwill impairment loss | 0 | 0 | ||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 33,409,251 | 24,015,427 | ||||
Contract Liabilities [Abstract] | ||||||
Deferred revenue | 422,905 | $ 50,000 | ||||
Earned grant revenue | $ 50,000 | |||||
Loss Per Share [Abstract] | ||||||
Options and warrants excluded from computation of earnings per share (in shares) | 711,968 | 810,670 | ||||
Fever Panel [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | $ 100,000 | |||||
Contract Liabilities [Abstract] | ||||||
Maximum amount of development agreement | 1,000,000 | |||||
Revenue from grants from inception | $ 900,000 | |||||
Zika Virus [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | $ 2,600,000 | |||||
Contract Liabilities [Abstract] | ||||||
Maximum amount of development agreement | 5,900,000 | |||||
Revenue from grants from inception | $ 5,300,000 | |||||
Bovid TB [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | $ 200,000 | |||||
Contract Liabilities [Abstract] | ||||||
Maximum amount of development agreement | 700,000 | |||||
Revenue from grants from inception | $ 500,000 | |||||
Exchange Transactions [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | $ 30,377,003 | |||||
Non-Exchange Transactions [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 3,032,248 | |||||
Africa [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 8,605,306 | |||||
Asia [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 1,389,120 | |||||
Europe & Middle East [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 4,726,691 | |||||
Latin America [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 11,722,224 | |||||
United States [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 6,965,910 | |||||
Net Product Sales [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 26,741,020 | $ 19,322,302 | ||||
Net Product Sales [Member] | Exchange Transactions [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 26,741,020 | |||||
Net Product Sales [Member] | Non-Exchange Transactions [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 0 | |||||
Net Product Sales [Member] | Africa [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 8,605,306 | 3,568,455 | ||||
Net Product Sales [Member] | Asia [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 1,389,120 | 1,626,750 | ||||
Net Product Sales [Member] | Europe & Middle East [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 2,172,031 | 1,763,274 | ||||
Net Product Sales [Member] | Latin America [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 11,722,224 | 8,476,003 | ||||
Net Product Sales [Member] | United States [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 2,852,339 | 3,887,820 | ||||
License and Royalty Revenue [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 948,773 | 741,534 | ||||
License and Royalty Revenue [Member] | Exchange Transactions [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 948,773 | |||||
License and Royalty Revenue [Member] | Non-Exchange Transactions [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 0 | |||||
R&D, Milestone and Grant Revenue [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 5,719,458 | |||||
R&D, Milestone and Grant Revenue [Member] | Exchange Transactions [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | 2,687,210 | |||||
R&D, Milestone and Grant Revenue [Member] | Non-Exchange Transactions [Member] | ||||||
Disaggregation of Revenue [Abstract] | ||||||
Total revenues | $ 3,032,248 | |||||
Minimum [Member] | ||||||
Fixed Assets [Abstract] | ||||||
Estimated useful lives of fixed assets | 3 years | |||||
Product Revenue [Abstract] | ||||||
Revenue, payment terms | 30 days | |||||
Maximum [Member] | ||||||
Fixed Assets [Abstract] | ||||||
Estimated useful lives of fixed assets | 7 years | |||||
Product Revenue [Abstract] | ||||||
Revenue, payment terms | 60 days | |||||
Money Market Funds [Member] | Level 1 [Member] | ||||||
Cash and Cash Equivalents [Abstract] | ||||||
Cash and cash equivalents | $ 4,700,000 | $ 2,100,000 |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Part 2 (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Goodwill and Intangible Assets [Assets] | ||
Impairment of intangible assets | $ 0 | $ 0 |
Goodwill [Roll Forward] | ||
Goodwill, Beginning balance | 1,666,610 | |
Acquisition of opTricon | 3,337,000 | |
Changes in foreign currency exchange rate | (20,483) | |
Goodwill, Ending balance | 4,983,127 | 1,666,610 |
Intangible assets [Abstract] | ||
Accumulated Amortization | 0 | 137,500 |
Net Book Value | 3,884,831 | 1,597,377 |
Amortization Expense [Abstract] | ||
Amortization expense | 233,734 | 398,234 |
2019 | 496,512 | |
2020 | 496,512 | |
2021 | 496,512 | |
2022 | 496,512 | |
2023 | 496,512 | |
Thereafter | $ 1,402,271 | |
Intellectual Property [Member] | ||
Intangible assets [Abstract] | ||
Weighted average remaining life of intangible assets | 10 years | |
Developed Technology [Member] | ||
Intangible assets [Abstract] | ||
Weighted average remaining life of intangible assets | 7 years | |
Customer Contracts / Relationships [Member] | ||
Intangible assets [Abstract] | ||
Weighted average remaining life of intangible assets | 8 years | |
Order Backlog [Member] | ||
Intangible assets [Abstract] | ||
Weighted average remaining life of intangible assets | 0 years | |
Trade Name [Member] | ||
Intangible assets [Abstract] | ||
Weighted average remaining life of intangible assets | 9 years | |
Plan [Member] | ||
Recent Accounting Pronouncements Affecting the Company [Abstract] | ||
Operating lease, right-of-use asset | $ 1,500,000 | |
Operating lease, liability | 1,500,000 | |
OpTricon and CDM [Member] | ||
Intangible assets [Abstract] | ||
Cost | 4,447,311 | 1,995,611 |
Accumulated Amortization | 562,480 | 398,234 |
Net Book Value | 3,884,831 | 1,597,377 |
OpTricon and CDM [Member] | Intellectual Property [Member] | ||
Intangible assets [Abstract] | ||
Cost | 1,089,688 | 886,872 |
Accumulated Amortization | 173,633 | 88,687 |
Net Book Value | 916,055 | 798,185 |
OpTricon and CDM [Member] | Developed Technology [Member] | ||
Intangible assets [Abstract] | ||
Cost | 1,910,315 | 0 |
Accumulated Amortization | 0 | 0 |
Net Book Value | 1,910,315 | 0 |
OpTricon and CDM [Member] | Customer Contracts / Relationships [Member] | ||
Intangible assets [Abstract] | ||
Cost | 1,121,600 | 776,013 |
Accumulated Amortization | 151,929 | 77,601 |
Net Book Value | 969,671 | 698,412 |
OpTricon and CDM [Member] | Order Backlog [Member] | ||
Intangible assets [Abstract] | ||
Cost | 217,187 | 221,867 |
Accumulated Amortization | 217,187 | 221,867 |
Net Book Value | 0 | 0 |
OpTricon and CDM [Member] | Trade Name [Member] | ||
Intangible assets [Abstract] | ||
Cost | 108,521 | 110,859 |
Accumulated Amortization | 19,731 | 10,079 |
Net Book Value | $ 88,790 | $ 100,780 |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
INVENTORIES [Abstract] | ||
Raw Materials | $ 2,803,677 | $ 1,767,684 |
Work in Process | 263,043 | 286,413 |
Finished Goods | 4,784,502 | 2,369,521 |
Inventories | $ 7,851,222 | $ 4,423,618 |
FIXED ASSETS (Details)
FIXED ASSETS (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Summary of fixed assets [Abstract] | ||
Less: Accumulated Depreciation and Amortization | $ (6,463,784) | $ (5,804,800) |
Fixed assets, net | 2,873,920 | 1,909,232 |
Depreciation expense | 634,261 | 727,563 |
Deposits on various pieces of equipment | 428,859 | 257,455 |
Machinery and Equipment [Member] | ||
Summary of fixed assets [Abstract] | ||
Fixed assets, gross | 6,070,137 | 4,582,759 |
Furniture and Fixtures [Member] | ||
Summary of fixed assets [Abstract] | ||
Fixed assets, gross | 35,287 | 449,548 |
Computer Equipment [Member] | ||
Summary of fixed assets [Abstract] | ||
Fixed assets, gross | 435,348 | 422,946 |
Leasehold Improvements [Member] | ||
Summary of fixed assets [Abstract] | ||
Fixed assets, gross | 2,334,512 | 2,258,779 |
Enterprise Business Systems [Member] | ||
Summary of fixed assets [Abstract] | ||
Fixed assets, gross | 462,420 | $ 0 |
Capital Leases [Member] | ||
Summary of fixed assets [Abstract] | ||
Fixed assets, net | 0 | |
Equipment Undergoing Validation [Member] | ||
Summary of fixed assets [Abstract] | ||
Fixed assets, gross | $ 1,866,126 |
ACCOUNTS PAYABLE AND ACCRUED _3
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract] | ||
Accounts Payable - suppliers | $ 3,622,765 | $ 1,494,759 |
Accrued Commissions | 588,131 | 126,827 |
Accrued Royalties / license fees | 279,213 | 429,297 |
Accrued Payroll | 48,867 | 187,305 |
Accrued Vacation | 264,789 | 309,767 |
Accrued Bonuses | 494,318 | 282,500 |
Accrued Expenses - Other | 590,598 | 215,848 |
Total | $ 5,888,681 | $ 3,046,303 |
DEFERRED RESEARCH AND DEVELOP_2
DEFERRED RESEARCH AND DEVELOPMENT REVENUE (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
DEFERRED RESEARCH AND DEVELOPMENT REVENUE [Abstract] | ||
Deferred revenue | $ 422,905 | $ 50,000 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | 24 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2003 | Dec. 31, 2005 | |
Current [Abstract] | ||||
Federal | $ 0 | $ (97,339) | ||
State | 10,914 | 9,034 | ||
Foreign | 0 | 0 | ||
Total current (benefit) provision | 10,914 | (88,305) | ||
Deferred [Abstract] | ||||
Federal | 0 | 0 | ||
State | 0 | 0 | ||
Foreign | (78,435) | 0 | ||
Total deferred (benefit) provision | (78,435) | 0 | ||
Total (benefit) provision | (67,521) | (88,305) | ||
Income Taxes [Abstract] | ||||
Cumulative charge was fully offset by an equivalent adjustment to deferred tax valuation allowance | 0 | 3,906,774 | ||
Cumulative benefit related to credit for ATM payment | 0 | (97,339) | ||
Net operating losses | $ 5,832,516 | $ 8,586,861 | ||
Annual limitation | 150,608 | 1,111,831 | ||
Built-in-gains of net operating losses | $ 488,207 | $ 1,756,842 | ||
Tax Credit Carryforward [Abstract] | ||||
Operating loss carryforwards, subject to expiration | 27,303,044 | |||
Operating loss carryforwards, not subject to expiration | 5,432,085 | |||
Components of Deferred Tax Assets and Liabilities [Abstract] [Abstract] | ||||
Inventory reserves | 204,206 | 244,158 | ||
Accrued expenses | 175,168 | 102,332 | ||
Net operating loss carry-forwards | 7,122,576 | 5,800,144 | ||
Research and development credit | 1,696,870 | 1,918,137 | ||
Stock-based compensation | 215,797 | 167,522 | ||
Depreciation | 139,362 | 91,258 | ||
Total deferred tax assets | 9,553,979 | 8,323,551 | ||
Intangible | (968,849) | (341,042) | ||
Total deferred tax liabilities | (968,849) | (341,042) | ||
Net deferred tax assets before valuation allowance | 8,585,130 | 7,982,509 | ||
Less valuation allowances | (9,477,438) | (8,323,551) | ||
Net noncurrent deferred tax liabilities | (892,308) | (341,042) | ||
Components of (loss) before income taxes [Abstract] | ||||
United States operations | (7,137,428) | (6,054,002) | ||
International operations | (795,742) | (406,063) | ||
(Loss) before taxes | $ (7,933,170) | $ (6,460,065) | ||
Taxes [Abstract] | ||||
Federal income tax at statutory rates | 21.00% | 34.00% | ||
State income taxes, net of federal benefit | (0.10%) | (0.09%) | ||
Nondeductible expenses | (1.58%) | (1.04%) | ||
Foreign rate differential | 0.36% | (2.14%) | ||
Change in valuation allowance | (18.44%) | (99.41%) | ||
Impact of Tax Act on valuation allowance | 0.00% | 60.48% | ||
AMT refund under Tax Act | 0.00% | 1.51% | ||
Tax credits | 0.00% | 7.07% | ||
Other | (0.39%) | 0.99% | ||
Income tax benefit | 0.85% | 1.37% | ||
Income Tax Contingencies [Abstract] | ||||
Open tax year | 2015 2016 2017 2018 | |||
State [Member] | ||||
Tax Credit Carryforward [Abstract] | ||||
Operating loss carryforwards, subject to expiration | $ 1,784,554 | |||
Foreign [Member] | ||||
Tax Credit Carryforward [Abstract] | ||||
Operating loss carryforwards, not subject to expiration | $ 586,206 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Nov. 30, 2018 | Feb. 28, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Common Stock [Abstract] | ||||
Underwritten public offering (in shares) | 2,726,000 | 1,783,760 | ||
Underwritten exercise of overallotment (in shares) | 355,565 | |||
Public offering price per share (in dollars per share) | $ 6.75 | $ 6.75 | ||
Net proceeds after underwriting discounts and other offering expenses | $ 16,500,000 | $ 10,900,000 | $ 27,476,260 | $ 0 |
Number of stock options exercised under the plan (in shares) | 144,947 | 56,969 | ||
Exercised (in shares) | 71,290 | 22,487 | ||
Exercise prices of stock option, minimum (in dollars per share) | $ 3.48 | $ 3.48 | ||
Exercise prices of stock option, maximum (in dollars per share) | $ 5.64 | $ 4.45 | ||
Preferred Stock [Abstract] | ||||
Preferred stock - shares authorized (in shares) | 10,000,000 | 10,000,000 | ||
Preferred stock - shares outstanding (in shares) | 0 | 0 | ||
Warrants [Abstract] | ||||
Warrants outstanding (in shares) | 0 | 0 |
RIGHTS AGREEMENT (Details)
RIGHTS AGREEMENT (Details) | 12 Months Ended |
Dec. 31, 2018Right | |
RIGHTS AGREEMENT [Abstract] | |
Number of preferred share purchase rights declared as dividend for each outstanding share of common stock | 1 |
Minimum combined ownership of outstanding shares of common stock by acquiring person | 20.00% |
STOCK INCENTIVE PLANS, Part 1 (
STOCK INCENTIVE PLANS, Part 1 (Details) - USD ($) | Sep. 22, 2011 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2018 | Jun. 19, 2014 | Jun. 03, 2008 |
Stock options, additional disclosure [Abstract] | |||||||
Outstanding, aggregate intrinsic value, end of period | $ 687,364 | ||||||
Exercisable, aggregate intrinsic value, end of period | 568,956 | ||||||
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract] | |||||||
Allocated share-based compensation expense | $ 632,805 | $ 384,897 | |||||
Stock Options [Member] | |||||||
Share-based Arrangements with Employees and Nonemployees [Abstract] | |||||||
Number of stock options exercised under the plan (in shares) | 144,947 | 56,969 | |||||
Number of stock options outstanding under the plan (in shares) | 810,670 | 600,549 | 600,549 | 711,968 | |||
Weighted average estimated grant-date fair value of stock options granted (in dollars per share) | $ 3.76 | $ 2.77 | |||||
Assumptions made in calculating fair values of options [Abstract] | |||||||
Expected term | 4 years 11 months 16 days | 5 years 5 months 23 days | |||||
Expected volatility | 39.91% | 43.31% | |||||
Risk-free interest rate | 2.70% | 1.78% | |||||
Stock options, number of shares [Roll forward] | |||||||
Outstanding, beginning of period (in shares) | 810,670 | 600,549 | |||||
Granted (in shares) | 93,750 | 267,875 | |||||
Exercised (in shares) | 144,947 | 56,969 | |||||
Forfeited/expired/cancelled (in shares) | 47,505 | 785 | |||||
Outstanding, end of period (in shares) | 711,968 | 810,670 | 600,549 | ||||
Exercisable, end of period (in shares) | 396,799 | 371,295 | |||||
Stock options, weighted average exercise price per share [Roll Forward] | |||||||
Outstanding, beginning of period (in dollars per share) | $ 5.18 | $ 4.55 | |||||
Granted (in dollars per share) | 9.80 | 6.40 | |||||
Exercised (in dollars per share) | 4.83 | 4.19 | |||||
Forfeited/expired/cancelled (in dollars per share) | 8.82 | 5.56 | |||||
Outstanding, end of period (in dollars per share) | 5.62 | 5.18 | $ 4.55 | ||||
Exercisable, end of period (in dollars per share) | $ 4.70 | $ 4.44 | |||||
Stock options, additional disclosure [Abstract] | |||||||
Outstanding, weighted average remaining contract term | 3 years 3 months 29 days | 3 years 8 months 8 days | 3 years 5 months 5 days | ||||
Exercisable, weighted average remaining contract term | 2 years 7 months 28 days | 2 years 7 months 13 days | |||||
Outstanding, aggregate intrinsic value, beginning of period | $ 2,477,853 | $ 1,463,052 | |||||
Granted, aggregate intrinsic value | 352,220 | ||||||
Exercised, aggregate intrinsic value | 523,327 | 100,018 | |||||
Forfeited/expired/cancelled, aggregate intrinsic value | 154,583 | ||||||
Outstanding, aggregate intrinsic value, end of period | 687,364 | 2,477,853 | $ 1,463,052 | ||||
Exercisable, aggregate intrinsic value, end of period | $ 568,956 | 1,409,440 | |||||
Net unrecognized compensation cost | $ 710,376 | ||||||
Weighted average period for recognition of net unrecognized compensation cost | 2 years 5 months 12 days | ||||||
Total fair value of stock options vested during period | $ 553,000 | ||||||
2008 Stock Incentive Plan [Member] | Stock Options [Member] | |||||||
Share-based Arrangements with Employees and Nonemployees [Abstract] | |||||||
Number of shares authorized under the plan (in shares) | 750,000 | 625,000 | |||||
Increase in number of shares authorized (in shares) | 125,000 | ||||||
Number of stock options exercised under the plan (in shares) | 508,889 | ||||||
Number of stock options outstanding under the plan (in shares) | 99,132 | 99,132 | |||||
Options still available to be issued (in shares) | 0 | ||||||
Stock options, number of shares [Roll forward] | |||||||
Exercised (in shares) | 508,889 | ||||||
Outstanding, end of period (in shares) | 99,132 | ||||||
2014 Stock Incentive Plan [Member] | Stock Options [Member] | |||||||
Share-based Arrangements with Employees and Nonemployees [Abstract] | |||||||
Number of shares authorized under the plan (in shares) | 800,000 | ||||||
Number of stock options exercised under the plan (in shares) | 85,407 | ||||||
Number of stock options outstanding under the plan (in shares) | 405,968 | 405,968 | |||||
Options still available to be issued (in shares) | 21,061 | ||||||
Stock options, number of shares [Roll forward] | |||||||
Exercised (in shares) | 85,407 | ||||||
Outstanding, end of period (in shares) | 405,968 | ||||||
2014 Stock Incentive Plan [Member] | Restricted Stock [Member] | |||||||
Share-based Arrangements with Employees and Nonemployees [Abstract] | |||||||
Number of restricted shares awarded under the plan (in shares) | 266,839 | ||||||
2014 Stock Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member] | |||||||
Share-based Arrangements with Employees and Nonemployees [Abstract] | |||||||
Number of restricted shares awarded under the plan (in shares) | 20,725 | ||||||
Cost of Goods Sold [Member] | |||||||
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract] | |||||||
Allocated share-based compensation expense | $ 25,615 | 47,000 | |||||
Research and Development Expense [Member] | |||||||
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract] | |||||||
Allocated share-based compensation expense | 78,831 | 89,400 | |||||
Selling, General and Administrative Expenses [Member] | |||||||
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract] | |||||||
Allocated share-based compensation expense | $ 528,360 | $ 248,497 |
STOCK INCENTIVE PLANS, Part 2 (
STOCK INCENTIVE PLANS, Part 2 (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Range of Exercise Prices [Abstract] | ||
Range of exercise prices, minimum (in dollars per share) | $ 3.48 | $ 3.48 |
Range of exercise prices, maximum (in dollars per share) | $ 5.64 | $ 4.45 |
Stock Options Outstanding [Abstract] | ||
Shares outstanding (in shares) | 711,968 | |
Average remaining contract life | 3 years 3 months 29 days | |
Weighted average exercise price (in dollars per share) | $ 5.62 | |
Aggregate intrinsic value | $ 687,364 | |
Stock Options Exercisable [Abstract] | ||
Shares exercisable (in shares) | 396,779 | |
Weighted average exercise price (in dollars per share) | $ 4.70 | |
Aggregate intrinsic value | $ 568,956 | |
1 to 2.79999 [Member] | ||
Range of Exercise Prices [Abstract] | ||
Range of exercise prices, minimum (in dollars per share) | $ 1 | |
Range of exercise prices, maximum (in dollars per share) | $ 2.79999 | |
Stock Options Outstanding [Abstract] | ||
Shares outstanding (in shares) | 0 | |
Average remaining contract life | 0 years | |
Weighted average exercise price (in dollars per share) | $ 0 | |
Aggregate intrinsic value | $ 0 | |
Stock Options Exercisable [Abstract] | ||
Shares exercisable (in shares) | 0 | |
Weighted average exercise price (in dollars per share) | $ 0 | |
Aggregate intrinsic value | $ 0 | |
2.8 to 4.59999 [Member] | ||
Range of Exercise Prices [Abstract] | ||
Range of exercise prices, minimum (in dollars per share) | $ 2.8 | |
Range of exercise prices, maximum (in dollars per share) | $ 4.59999 | |
Stock Options Outstanding [Abstract] | ||
Shares outstanding (in shares) | 304,343 | |
Average remaining contract life | 1 year 10 months 24 days | |
Weighted average exercise price (in dollars per share) | $ 3.45 | |
Aggregate intrinsic value | $ 672,896 | |
Stock Options Exercisable [Abstract] | ||
Shares exercisable (in shares) | 254,343 | |
Weighted average exercise price (in dollars per share) | $ 3.46 | |
Aggregate intrinsic value | $ 560,711 | |
4.6 to 6.39999 [Member] | ||
Range of Exercise Prices [Abstract] | ||
Range of exercise prices, minimum (in dollars per share) | $ 4.6 | |
Range of exercise prices, maximum (in dollars per share) | $ 6.39999 | |
Stock Options Outstanding [Abstract] | ||
Shares outstanding (in shares) | 152,875 | |
Average remaining contract life | 3 years 5 months 5 days | |
Weighted average exercise price (in dollars per share) | $ 5.85 | |
Aggregate intrinsic value | $ 14,468 | |
Stock Options Exercisable [Abstract] | ||
Shares exercisable (in shares) | 58,020 | |
Weighted average exercise price (in dollars per share) | $ 5.80 | |
Aggregate intrinsic value | $ 8,245 | |
6.4 to 8.19999 [Member] | ||
Range of Exercise Prices [Abstract] | ||
Range of exercise prices, minimum (in dollars per share) | $ 6.4 | |
Range of exercise prices, maximum (in dollars per share) | $ 8.19999 | |
Stock Options Outstanding [Abstract] | ||
Shares outstanding (in shares) | 207,875 | |
Average remaining contract life | 5 years 18 days | |
Weighted average exercise price (in dollars per share) | $ 7.31 | |
Aggregate intrinsic value | $ 0 | |
Stock Options Exercisable [Abstract] | ||
Shares exercisable (in shares) | 75,041 | |
Weighted average exercise price (in dollars per share) | $ 7.21 | |
Aggregate intrinsic value | $ 0 | |
8.2 to 12 [Member] | ||
Range of Exercise Prices [Abstract] | ||
Range of exercise prices, minimum (in dollars per share) | $ 8.2 | |
Range of exercise prices, maximum (in dollars per share) | $ 12 | |
Stock Options Outstanding [Abstract] | ||
Shares outstanding (in shares) | 46,875 | |
Average remaining contract life | 4 years 7 months 6 days | |
Weighted average exercise price (in dollars per share) | $ 11.45 | |
Aggregate intrinsic value | $ 0 | |
Stock Options Exercisable [Abstract] | ||
Shares exercisable (in shares) | 9,375 | |
Weighted average exercise price (in dollars per share) | $ 11.45 | |
Aggregate intrinsic value | $ 0 |
STOCK INCENTIVE PLANS, Part 3 (
STOCK INCENTIVE PLANS, Part 3 (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Weighted Average Grant Date Fair Value [Abstract] | ||
Allocated share-based compensation expense | $ 632,805 | $ 384,897 |
Restricted Stock and Restricted Stock Units [Member] | ||
Number of Shares & Units [Abstract] | ||
Outstanding, beginning of period (in shares) | 0 | |
Granted (in shares) | 287,564 | |
Exercised (in shares) | 0 | |
Forfeited/expired/cancelled (in shares) | 0 | |
Outstanding, end of period (in shares) | 287,564 | 0 |
Exercisable (in shares) | 0 | |
Weighted Average Grant Date Fair Value [Abstract] | ||
Outstanding, beginning of period (in dollars per share) | $ 0 | |
Granted (in dollars per share) | 9.65 | |
Exercised (in dollars per share) | 0 | |
Forfeited/expired/cancelled (in dollars per share) | 0 | |
Outstanding, end of period (in dollars per share) | 9.65 | $ 0 |
Exercisable (in dollars per share) | $ 0 | |
Net unrecognized compensation cost | $ 1,688,746 | |
Weighted average period for recognition of net unrecognized compensation cost | 2 years 6 months | |
Allocated share-based compensation expense | $ 281,249 | $ 0 |
GEOGRAPHIC INFORMATION AND EC_3
GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Geographic Areas, Revenues from External Customers [Abstract] | ||
Net sales | $ 33,409,251 | $ 24,015,427 |
Geographic Areas, Long-Lived Assets [Abstract] | ||
Long-lived assets | 2,873,920 | 1,909,232 |
Net Product Sales [Member] | ||
Geographic Areas, Revenues from External Customers [Abstract] | ||
Net sales | 26,741,020 | 19,322,302 |
License and Royalty Revenue [Member] | ||
Geographic Areas, Revenues from External Customers [Abstract] | ||
Net sales | 948,773 | 741,534 |
R&D, Milestone and Grant Revenue [Member] | ||
Geographic Areas, Revenues from External Customers [Abstract] | ||
Net sales | 5,719,458 | |
Africa [Member] | ||
Geographic Areas, Revenues from External Customers [Abstract] | ||
Net sales | 8,605,306 | |
Africa [Member] | Net Product Sales [Member] | ||
Geographic Areas, Revenues from External Customers [Abstract] | ||
Net sales | 8,605,306 | 3,568,455 |
Asia [Member] | ||
Geographic Areas, Revenues from External Customers [Abstract] | ||
Net sales | 1,389,120 | |
Geographic Areas, Long-Lived Assets [Abstract] | ||
Long-lived assets | 466,185 | 472,774 |
Asia [Member] | Net Product Sales [Member] | ||
Geographic Areas, Revenues from External Customers [Abstract] | ||
Net sales | 1,389,120 | 1,626,750 |
Europe & Middle East [Member] | ||
Geographic Areas, Revenues from External Customers [Abstract] | ||
Net sales | 4,726,691 | |
Geographic Areas, Long-Lived Assets [Abstract] | ||
Long-lived assets | 123,752 | 0 |
Europe & Middle East [Member] | Net Product Sales [Member] | ||
Geographic Areas, Revenues from External Customers [Abstract] | ||
Net sales | 2,172,031 | 1,763,274 |
Latin America [Member] | ||
Geographic Areas, Revenues from External Customers [Abstract] | ||
Net sales | 11,722,224 | |
Latin America [Member] | Net Product Sales [Member] | ||
Geographic Areas, Revenues from External Customers [Abstract] | ||
Net sales | 11,722,224 | 8,476,003 |
United States [Member] | ||
Geographic Areas, Revenues from External Customers [Abstract] | ||
Net sales | 6,965,910 | |
Geographic Areas, Long-Lived Assets [Abstract] | ||
Long-lived assets | 2,283,983 | 1,436,458 |
United States [Member] | Net Product Sales [Member] | ||
Geographic Areas, Revenues from External Customers [Abstract] | ||
Net sales | $ 2,852,339 | $ 3,887,820 |
COMMITMENTS, CONTINGENCIES AN_3
COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS (Details) | 12 Months Ended | ||||
Dec. 31, 2018USD ($)KeyEmployeeLease | Dec. 31, 2017USD ($) | ||||
Employment Contracts [Abstract] | |||||
Number of key employees with whom Company has employment contracts | KeyEmployee | 2 | ||||
Aggregate annual salaries of employment contracts | $ 770,000 | ||||
Contract one, expiration date | Mar. 31, 2019 | ||||
Contract two, expiration date | Mar. 31, 2020 | ||||
Future minimum salary commitments [Abstract] | |||||
2019 | $ 485,493 | ||||
2020 | $ 85,000 | ||||
Pension Plan [Abstract] | |||||
Percentage of employer's matching contribution | 40.00% | ||||
Expenses related to matching contribution | $ 94,544 | $ 91,150 | |||
Schedule of future minimum rental commitments [Abstract] | |||||
2019 | 384,308 | ||||
2020 | 88,576 | ||||
2021 | 0 | ||||
Total | 472,884 | ||||
Rent expense | 653,155 | 586,730 | |||
Economic Dependency [Abstract] | |||||
Net sales | 33,409,251 | 24,015,427 | |||
Accounts Receivable | 7,373,971 | 2,085,340 | |||
Purchases | 21,427,243 | 12,921,157 | |||
Customer Concentration Risk [Member] | Customer 1 [Member] | |||||
Economic Dependency [Abstract] | |||||
Accounts Receivable | 3,499,340 | 0 | |||
Customer Concentration Risk [Member] | Customer 2 [Member] | |||||
Economic Dependency [Abstract] | |||||
Accounts Receivable | 1,033,824 | 0 | |||
Supplier Concentration Risk [Member] | Vendor 1 [Member] | |||||
Economic Dependency [Abstract] | |||||
Accounts Payable | [1] | ||||
Supplier Concentration Risk [Member] | Vendor 2 [Member] | |||||
Economic Dependency [Abstract] | |||||
Accounts Payable | [1] | ||||
Supplier Concentration Risk [Member] | Vendor 3 [Member] | |||||
Economic Dependency [Abstract] | |||||
Accounts Payable | [1] | ||||
Supplier Concentration Risk [Member] | Vendor 4 [Member] | |||||
Economic Dependency [Abstract] | |||||
Accounts Payable | $ 164,312 | [1] | |||
Maximum [Member] | |||||
Pension Plan [Abstract] | |||||
Employee contribution subject to employer matching contribution | 5.00% | ||||
Employer matching contribution | 2.00% | ||||
Medford [Member] | |||||
Lease, Amount [Abstract] | |||||
Monthly rent | $ 30,140 | ||||
Lease expiration date | Apr. 30, 2019 | ||||
Percentage of monthly rent increase in year three through five | 2.50% | ||||
Holbrook [Member] | |||||
Lease, Amount [Abstract] | |||||
Monthly rent | $ 16,709 | ||||
Lease expiration date | Apr. 30, 2020 | ||||
Percentage of monthly rent increase in year three through five | 3.00% | ||||
Kuala Lumpur [Member] | |||||
Lease, Amount [Abstract] | |||||
Monthly rent | $ 5,400 | ||||
Lease expiration date | Apr. 30, 2020 | ||||
Number of separate leases | Lease | 2 | ||||
Number of additional year of renewal option | 3 years | ||||
Germany [Member] | |||||
Lease, Amount [Abstract] | |||||
Monthly rent | $ 13,445 | ||||
Percentage of monthly rent increase in year three through five | 2.00% | ||||
Sales [Member] | Customer Concentration Risk [Member] | |||||
Economic Dependency [Abstract] | |||||
Concentration risk percentage | 10.00% | ||||
Sales [Member] | Customer Concentration Risk [Member] | Customer 1 [Member] | |||||
Economic Dependency [Abstract] | |||||
Concentration risk percentage | 42.00% | 42.00% | |||
Net sales | $ 11,171,174 | $ 8,065,217 | |||
Sales [Member] | Customer Concentration Risk [Member] | Customer 2 [Member] | |||||
Economic Dependency [Abstract] | |||||
Concentration risk percentage | 16.00% | 0.00% | |||
Net sales | $ 4,346,640 | $ 0 | |||
Purchases [Member] | Supplier Concentration Risk [Member] | |||||
Economic Dependency [Abstract] | |||||
Concentration risk percentage | 10.00% | ||||
Purchases [Member] | Supplier Concentration Risk [Member] | Vendor 1 [Member] | |||||
Economic Dependency [Abstract] | |||||
Concentration risk percentage | [1] | ||||
Purchases | [1] | ||||
Purchases [Member] | Supplier Concentration Risk [Member] | Vendor 2 [Member] | |||||
Economic Dependency [Abstract] | |||||
Concentration risk percentage | [1] | 12.00% | |||
Purchases | [1] | $ 746,868 | |||
Purchases [Member] | Supplier Concentration Risk [Member] | Vendor 3 [Member] | |||||
Economic Dependency [Abstract] | |||||
Concentration risk percentage | [1] | 14.00% | |||
Purchases | [1] | $ 849,966 | |||
Purchases [Member] | Supplier Concentration Risk [Member] | Vendor 4 [Member] | |||||
Economic Dependency [Abstract] | |||||
Concentration risk percentage | 16.00% | 14.00% | |||
Purchases | $ 1,646,614 | $ 884,698 | |||
[1] | Purchases from the vendor did not exceed 10% for the period indicated. |
NOTE PAYABLE (Details)
NOTE PAYABLE (Details) - Note Payable - Equipment Vendor [Member] - USD ($) | 1 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2018 | |
Debt Instruments [Abstract] | ||
Debt instrument, face amount | $ 660,000 | |
Percentage of first prepayment of the term | 30.00% | |
Percentage of second prepayment of the term | 60.00% | |
Percentage of prepayment after delivery | 10.00% | |
Percentage of first prepayment of the term by the vendor | 15.00% | |
Percentage of second prepayment of the term by the vendor | 40.00% | |
Percentage of prepayment after delivery by the vendor | 10.00% | |
Annual interest rate | 12.00% | |
Periodic payment debt instrument, principal and interest | $ 20,150 | |
Term of debt instrument | 24 months |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - Subsequent Event [Member] | Feb. 05, 2019USD ($)ft²Term |
Hauppauge [Member] | |
Leases [Abstract] | |
Lease of office space | ft² | 70,000 |
Initial lease term | 11 years |
Number of additional terms that lease term can be extended | Term | 2 |
Initial lease term extension for each term | 5 years |
Rent under lease | $ 900,000 |
Approximate percentage increase in rent per year | 3.00% |
Security deposit and payment of four months base rent | $ 450,000 |
Free rent period | 9 months |
Holbrook [Member] | |
Leases [Abstract] | |
Percentage of rent receivable from sublessee | 50.00% |
Sublease rent | $ 100,000 |