0001140361-21-008210 | 10-K | XBRL Viewer

Document and Entity Information - USD ($)	12 Months Ended
Document and Entity Information - USD ($)	Dec. 31, 2020	Mar. 11, 2021	Jun. 30, 2020
Cover [Abstract]
Entity Registrant Name	CHEMBIO DIAGNOSTICS, INC.
Entity Central Index Key	0001092662
Current Fiscal Year End Date	--12-31
Document Type	10-K
Amendment Flag	false
Document Annual Report	true
Document Period End Date	Dec. 31, 2020
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	FY
Document Transition Report	false
Entity File Number	000-30379
Entity Incorporation, State or Country Code	NV
Entity Tax Identification Number	88-0425691
Entity Address, Address Line One	555 Wireless, Boulevard,
Entity Address, City or Town	Hauppauge
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	11788
City Area Code	631
Local Phone Number	924-1135
Title of 12(b) Security	Common Stock, $0.01 par value
Trading Symbol	CEMI
Security Exchange Name	NASDAQ
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Public Float			$ 0
Entity Common Stock, Shares Outstanding		20,182,357

CONSOLIDATED BALANCE SHEETS - USD ($)	Dec. 31, 2020	Dec. 31, 2019
CURRENT ASSETS:
Cash and cash equivalents	$ 23,066,301	$ 18,271,352
Accounts receivable, net of allowance for doubtful accounts of $296,793 and $62,000 at December 31, 2020 and 2019, respectively	3,377,387	3,661,325
Inventories, net	12,516,402	9,598,030
Prepaid expenses and other current assets	778,683	693,013
TOTAL CURRENT ASSETS	39,738,773	32,223,720
FIXED ASSETS:
Property, plant and equipment, net	8,688,403	5,933,569
Finance lease right-of-use asset, net	233,134	210,350
OTHER ASSETS:
Operating right-of-use assets, net	6,112,632	7,030,744
Intangible assets, net	3,645,986	3,914,352
Goodwill	5,963,744	5,872,690
Deposits and other assets	509,342	543,539
TOTAL ASSETS	64,892,014	55,728,964
CURRENT LIABILITIES:
Accounts payable and accrued liabilities	10,042,790	5,526,243
Deferred revenue	1,606,997	125,000
Notes Payable	0	180,249
Operating lease liabilities	642,460	568,294
Finance lease liabilities	58,877	41,894
TOTAL CURRENT LIABILITIES	12,351,124	6,441,680
OTHER LIABILITIES:
Long-term operating lease liabilities	6,327,143	6,969,603
Long-term finance lease liabilities	185,239	171,953
Long-term debt, less current portion, net	18,182,158	17,644,149
Deferred tax liability	69,941	466,326
TOTAL LIABILITIES	37,115,605	31,693,711
COMMITMENTS AND CONTINGENCIES (Note 12)
STOCKHOLDERS' EQUITY:
Preferred stock - 10,000,000 shares authorized; none outstanding	0	0
Common stock - $.01 par value; 100,000,000 shares authorized, 20,223,498 and 17,733,617 shares issued and outstanding at December 31, 2020 and 2019, respectively	202,235	177,335
Additional paid-in capital	124,961,514	95,433,077
Accumulated deficit	(97,106,331)	(71,585,003)
Treasury stock - 41,141 and 0 shares at cost, at December 31, 2020 and 2019, respectively	(190,093)	0
Accumulated other comprehensive income	(90,916)	9,844
TOTAL STOCKHOLDERS' EQUITY	27,776,409	24,035,253
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 64,892,014	$ 55,728,964

CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
CURRENT ASSETS:
Accounts receivable, allowance for doubtful accounts	$ 296,793	$ 62,000
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)	20,223,498	17,733,617
Common stock, shares outstanding (in shares)	20,223,498	17,733,617
Treasury stock, shares (in shares)	41,141	0

CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	Dec. 31, 2020	Dec. 31, 2019
REVENUES:
REVENUES	$ 32,470,197	$ 34,464,032
COSTS AND EXPENSES:
Cost of product sales	23,874,487	22,394,317
Research and development expenses	9,508,494	8,538,416
Selling, general and administrative expenses	21,037,701	16,138,424
Severance and related costs	1,122,310	0
Acquisition costs	63,497	721,465
TOTAL COSTS AND EXPENSES	55,606,489	47,792,622
LOSS FROM OPERATIONS	(23,136,292)	(13,328,590)
OTHER (EXPENSE) INCOME:
Interest expense, net	(2,841,830)	(846,831)
LOSS BEFORE INCOME TAX BENEFIT	(25,978,122)	(14,175,421)
Income tax benefit	456,794	500,292
NET LOSS	$ (25,521,328)	$ (13,675,129)
Basic and diluted loss per share (in dollars per share)	$ (1.34)	$ (0.81)
Weighted average number of shares outstanding, basic and diluted (in shares)	19,085,691	16,954,142
Product Revenue [Member]
REVENUES:
REVENUES	$ 24,767,149	$ 28,844,997
R&D Revenue [Member]
REVENUES:
REVENUES	4,851,562	4,025,538
Government Grant Income [Member]
REVENUES:
REVENUES	2,018,924	654,744
License and Royalty Revenue [Member]
REVENUES:
REVENUES	$ 832,562	$ 938,753

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($)	Dec. 31, 2020	Dec. 31, 2019
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS [Abstract]
Net loss	$ (25,521,328)	$ (13,675,129)
Other comprehensive loss:
Foreign currency translation adjustments	(100,760)	(102,352)
COMPREHENSIVE LOSS	$ (25,622,088)	$ (13,777,481)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($)	Common Stock [Member]	Additional Paid-in-Capital [Member]	Treasury Stock [Member]	Accumulated Deficit [Member]	Associated Other Comprehensive Income [Member]	Total
Balance at Dec. 31, 2018	$ 171,664	$ 90,953,788	$ 0	$ (57,909,874)	$ 112,196	$ 33,327,774
Balance (in shares) at Dec. 31, 2018	17,166,459		0
Common Stock:
Restricted stock issued	$ 3,819	(128,081)	$ 0	0	0	(124,262)
Restricted stock issued (in shares)	381,908		0
Restricted stock compensation, net	$ 0	1,394,812	$ 0	0	0	1,394,812
Restricted stock compensation, net (in shares)			0
Issuance of common stock for business acquired	$ 1,537	441,754	$ 0	0	0	443,291
Issuance of common stock for business acquired (in shares)	153,707		0
Options:
Exercised	$ 315	32,171	$ 0	0	0	$ 32,486
Exercised (in shares)	31,543		0			31,543
Stock option compensation	$ 0	261,088	$ 0	0	0	$ 261,088
Warrants and Other:
Warrant on Term Debt	0	1,196,093	0	0	0	1,196,093
Contingent Earnout for business acquired	0	1,281,452	0	0	0	1,281,452
Comprehensive loss	0	0	0	0	(102,352)	(102,352)
Net loss	0	0	0	(13,675,129)	0	(13,675,129)
Balance at Dec. 31, 2019	$ 177,335	95,433,077	$ 0	(71,585,003)	9,844	24,035,253
Balance (in shares) at Dec. 31, 2019	17,733,617		0
Common Stock:
Issuance of stock, net	$ 26,196	28,410,544	$ 0	0	0	28,436,740
Issuance of stock, net (in shares)	2,619,593		0
Restricted stock issued	$ 819	128,356	$ 0	0	0	129,175
Restricted stock issued (in shares)	81,773		0
Restricted stock compensation, net	$ (4,702)	617,919	$ 0	0	0	613,217
Restricted stock compensation, net (in shares)	(470,174)		0
Shares tendered for withholding taxes	$ 0	(296,667)	$ 0	0	0	(296,667)
Options:
Exercised	$ 55	(55)				$ 0
Exercised (in shares)	5,528					5,528
Stock option compensation	$ 0	480,779	0	0	0	$ 480,779
Warrants and Other:
Warrants exercised	$ 2,532	(2,532)	0	0	0	0
Warrants exercised (in shares)	253,161
Treasury stock		190,093	$ (190,093)			0
Treasury stock (in shares)			(41,141)
Comprehensive loss		0	$ 0	0	(100,760)	(100,760)
Net loss	$ 0	0	0	(25,521,328)	0	(25,521,328)
Balance at Dec. 31, 2020	$ 202,235	$ 124,961,514	$ (190,093)	$ (97,106,331)	$ (90,916)	$ 27,776,409
Balance (in shares) at Dec. 31, 2020	20,223,498		(41,141)

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	Dec. 31, 2020	Dec. 31, 2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Cash received from customers and grants	$ 34,736,133	$ 37,930,172
Cash paid to suppliers and employees	(50,238,409)	(45,655,562)
Cash paid for operating leases	(1,139,944)	(632,952)
Cash paid for finance leases	(19,987)	(7,892)
Interest and taxes, net	(2,225,031)	(689,272)
Net cash used in operating activities	(18,887,238)	(9,055,506)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of businesses, net of cash acquired	0	(100,000)
Acquisition of and deposits on fixed assets	(3,961,369)	(3,502,540)
Patent application costs	(205,493)	(297,006)
Working capital adjustment related to business combination	0	145,760
Net cash used in investing activities	(4,166,862)	(3,753,786)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from sale of common stock, net	28,436,740	0
Proceeds from option exercises	0	32,486
Principal payments for finance leases	(51,166)	(19,875)
Payments on debt issuance costs	0	(186,313)
Payments on note payable	(180,249)	(181,822)
Proceeds from issuance of long-term debt, net	0	18,850,000
Stimulus package loan	2,978,315	0
Payment of stimulus package loan	(2,978,315)	0
Payments of tax withholding on stock award	(441,723)	0
Net cash provided by financing activities	27,763,602	18,494,476
Effect of exchange rate changes on cash	85,447	61,617
INCREASE IN CASH AND CASH EQUIVALENTS	4,794,949	5,746,801
Cash and cash equivalents - beginning of the period	18,271,352	12,524,551
Cash and cash equivalents - end of the period	23,066,301	18,271,352
RECONCILIATION OF NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES:
Net loss	(25,521,328)	(13,675,129)
Adjustments:
Depreciation and amortization	2,697,126	1,916,194
Share based compensation	1,223,171	1,655,900
Benefit from deferred tax liability	(396,385)	(513,715)
Provision for doubtful accounts	270,193	20,000
Non-cash inventory changes	3,543,515	0
Changes in assets and liabilities, net of effects from acquisitions:
Accounts receivable	283,939	3,764,045
Inventories	(6,461,887)	(1,457,612)
Prepaid expenses and other current assets	(85,670)	64,355
Deposits and other assets	34,195	(90,624)
Accounts payable and accrued liabilities	4,043,896	(441,015)
Deferred revenue	1,481,997	(297,905)
Net cash used in operating activities	(18,887,238)	(9,055,506)
Supplemental disclosures for non-cash investing and financing activities:
Deposits on manufacturing equipment transferred to fixed assets	472,651	430,000
Issuance of common stock for net assets of business acquired	0	443,291
Contingent liability earnout	$ 1,011,261	$ 1,225,000

DESCRIPTION OF BUSINESS	12 Months Ended
DESCRIPTION OF BUSINESS	Dec. 31, 2020
DESCRIPTION OF BUSINESS [Abstract]
DESCRIPTION OF BUSINESS	NOTE 1 — DESCRIPTION OF BUSINESS: Chembio Diagnostics, Inc. (“Chembio”) and its subsidiaries (collectively with Chembio, the “Company”) develop and commercialize point-of-care rapid tests used for the detection and diagnosis of infectious diseases, including COVID-19, sexually transmitted disease, and fever and tropical disease. Coupled with the Company’s extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease. Chembio’s products are sold globally, directly and through distributors, to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers under the Company’s DPP, STAT PAK, SURE CHECK and STAT-VIEW registered trademarks or under the private labels of the Company’s marketing partners. The Company has been expanding its product portfolio based upon its proprietary DPP technology platform that provides high-quality, rapid diagnostic results in 15 to 20 minutes using a small drop of blood from the fingertip or alternative samples. Through advanced multiplexing, the DPP platform can detect up to eight, distinct test results from a single patient sample, which can deliver greater clinical value than other rapid tests. For certain applications, Chembio’s easy-to-use, highly portable, battery-operated DPP Micro Reader optical analyzer then reports accurate results in approximately 15 seconds, making it well-suited for decentralized testing where real-time results enable patients to be clinically assessed while they are still onsite. Objective results produced by the DPP Micro Reader can reduce the possibility of the types of human error that can be experienced in the visual interpretations required by many rapid tests. All DPP tests are developed and manufactured in the United States and are the subject of a range of domestic and global patents and patents pending. During 2020, the Company refocused its business strategy on the development and commercialization of the DPP COVID-19 IgM/IgG System, which consists of a new serological test for COVID-19 and a Micro Reader analyzer. In the twelve months ended December 31, 2020, the Company developed, received regulatory approval in the US, Brazil and Europe, and commercialized the DPP COVID-19 IgM/IgG System, which provided numerical readings for both IgM and IgG levels of antibodies to the virus, and began developing its strategy for a portfolio of products both related to and expanding beyond COVID-19. On June 16, 2020, the U.S. FDA Food and Drug Administration (the “FDA”) revoked the Company’s Emergency Use Authorization (“EUA”) for the DPP COVID-19 System in the U.S., and the Company immediately began developing a revised version. The Company submitted an application for EUA to the FDA for its new rapid antibody test system, DPP SARS-CoV-2 IgM/IgG on September 8, 2020 (the “IgM/IgG EUA”). On December 3, 2020, the Company received from the FDA a letter responding to the IgM/IgG EUA. The response letter stated that, given the volume of EUA requests it has received, the FDA was prioritizing review of EUA requests for tests, taking into account a variety of factors such as the public health need for the product and the availability of the product. The response letter further stated that the FDA determined that review of the IgM/IgG EUA request was not a priority because, for example, authorization of the test would have relatively limited impact on testing accessibility or testing capacity, and therefore the FDA declined to review the IgM/IgG EUA request at that time. On July 6, 2020, the Company received a $628,071 grant from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures (“BARDA”) to assist the Company in developing a COVID-19 point-of-care antigen system using Chembio’s proprietary DPP technology and submitting an application for EUA to the FDA for the system. On October 15, 2020, Chembio submitted the EUA application for the DPP SARS-CoV-2 Antigen test system, which was designed to detect SARS-CoV-2 antigens in only 20 minutes. The DPP SARS-CoV-2 Antigen test system consists of a DPP SARS-CoV-2 Antigen test cartridge, a DPP Micro Reader optical analyzer and a minimally-invasive nasal swab. On December 2, 2020, the Company received a $12,691,726 grant from BARDA to support the development and pursuit of FDA EUA for a rapid, multiplex DPP Respiratory Antigen Panel point-of-care test system. The contract also supports preparation of a submission in pursuit of FDA 510(k) clearance for the Company’s rapid DPP SARS-CoV-2 Antigen test system. The DPP Respiratory Antigen Panel test system is intended to provide simultaneous, discrete, and differential detection of Influenza A, Influenza B, and SARS-CoV-2 antigens from a single patient respiratory specimen, such as a nasal or nasopharyngeal swab. It is expected to provide results in approximately 20 minutes and be run on Chembio’s DPP Micro Reader analyzer. The system is intended to enable appropriate clinical management of patients with suspected respiratory infections and assist in the containment of COVID-19 cases during the flu season. In addition to its DPP COVID-19 rapid test products, the Company has a broad portfolio of infectious disease products, which it expects to generate a diminished amount of revenue for the foreseeable future both due to the impact of the global COVID-19 pandemic and while it focuses on the development, manufacture, and commercialization of DPP COVID-19 products. Through Research & Development (“R&D”) Services, the Company is developing tests in collaboration with Takeda Pharmaceutical Company Limited.

SIGNIFICANT ACCOUNTING POLICIES

12 Months Ended

Dec. 31, 2020

SIGNIFICANT ACCOUNTING POLICIES [Abstract]

SIGNIFICANT ACCOUNTING POLICIES

NOTE 2 — SIGNIFICANT ACCOUNTING POLICIES:

(a) Basis of Presentation:

The accompanying consolidated financial statements include the accounts of Chembio and its subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.

The Company’s future working capital needs will depend on many factors, including the rate of its business and revenue growth, the timing of its continuing automation of U.S. manufacturing, and the timing of its investment in research and development as well as sales and marketing. If the Company is unable to increase its revenues and manage its expenses in accordance with its operating plan, it may need to reduce the level or slow the timing of the growth plans contemplated by its operating plan, which would likely curtail or delay the growth in its business contemplated by its operating plan and could impair or defer its ability to achieve profitability and generate cash flow, or to seek to raise additional funds through debt or equity financing, strategic relationships, or other arrangements.

Certain amounts related to other government income in the prior period financial statements have been reclassified to conform to the presentation of the current period financial statements.

(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, 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.

The carrying value for cash and cash equivalents, accounts receivable, accounts payable, accrued expenses and other current liabilities approximate fair value due to the immediate or short-term maturity of these financial instruments. Included in cash and cash equivalents is $14.8 million and $16.0 million as of December 31, 2020 and 2019, respectively, of money market funds that are Level 1 fair value measurements under the hierarchy. The fair value of the Company’s total debt of $20 million (carrying value of $18.2 million) and $20 million (carrying value of $17.6 million) as of December 31, 2020 and 2019, respectively, is a Level 2 fair value measurement under the hierarchy, and the carrying value approximates fair value.

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 at date of purchase, and include restricted cash of $1 million and $0 as of December 31, 2020 and 2019, respectively.

The Company is contractually obligated to maintain the restricted cash balance on deposit with a bank as security for the bank’s issuance of a guarantee on behalf of the Company for its performance under purchase orders from which the Company received advance payments by a customer. The Company expects that the restriction will be released within the next twelve months..

(e) Concentrations of Credit Risk:

Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and trade receivables. The Company places its cash 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) Inventory:

Inventories are stated at the lower of cost or net realizable value with cost being determined using a standard cost method, which approximates average cost. Average cost consists primarily of material, labor and manufacturing overhead expenses (including fixed production-overhead costs). The Company analyzes its inventory levels quarterly and writes down, in the applicable period, inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected customer demand. The Company also writes off, in the applicable period, the costs related to expired inventory. Costs of purchased inventories are recorded using weighted-average costing.

(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) 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, 2020 and 2019.

(i) Revenue Recognition:

The Company recognizes revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. The Company recognizes revenue following the five-step model prescribed under Accounting Standards Update (“ASU”) 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 revenue when (or as) the Company satisfies the performance obligation.

Product Revenue

Revenue 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 the product 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 when 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 excludes certain taxes from the transaction price (e.g., sales, value added and some excise taxes).

The Company’s contracts with customers often include promises to transfer products or services to a customer. Determining whether products and services are considered distinct performance obligations that should be accounted for separately versus together may require judgment. Typical products sold are diagnostic tests and typical services performed are R&D studies. Revenues from product sales are recognized at a point-in-time and revenues from R&D studies are recognized ratably, over the period of the agreement, unless the related performance obligations indicate otherwise.

Judgment is required to determine the stand-alone selling price (“SSP”) for each distinct performance obligation. SSP is directly observable and the Company can use a range of amounts to estimate SSP, as it sells products and services separately, and can determine whether there is a discount to be allocated based on the relative SSP of the various products and services, for the various geographies.

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

Revenue 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 revenue, are generally related to discounts and returns. 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, market events and trends, and the specific facts and circumstances of each arrangement. The transaction price, which includes variable consideration reflecting the impact of discounts, allowances and returns 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 revenue 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 revenue and earnings in the period of adjustment.

License and Royalty Revenues

The Company receives royalty revenue on sales by its licensee of products covered under patents that the Company owns. The Company does not have future performance obligations under this license arrangement. The Company records revenue based on estimates of the sales that occurred during the relevant period as a component of license and royalty revenue. The relevant period estimates of sales are based on interim data provided by the licensee 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 revenue 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 Revenue

All contracts with customers are evaluated under the five-step model described above. Such contracts are further described in Note 7 - Revenue. Grants are invoiced and revenue is recognized ratably as that is the depiction of the timing of the transfer of services. The R&D study, which encompasses various phases of product development processes: design feasibility & planning, product development and design optimization, design verification, design validation and process validation, and pivotal studies, is also recognized ratably.

For certain contracts that represent non-governmental grants where the funder does not meet the definition of a customer, the Company recognizes revenue when earned in accordance with Accounting Standards Codification (“ASC”) Topic 958.

Government Grant Income

Chembio often receives government grants in support of R&D activities that are not associated with a customer-vendor relationship and therefore falls outside the scope of ASC 606. Because there is no authoritative guidance under U.S. GAAP on accounting for government grants received, Chembio applies Topic 958 - Not-for-profit entities guidance by analogy. In June 2018, the Financial Accounting Standards Board (the “FASB”) issued ASU 2018-08, Not-for-Profit Entities (Topic 958): Clarifying the Scope and the Accounting Guidance for Contributions Received and Contributions Made. This ASU clarifies the guidance presented in ASC Topic 958, “Not-for-Profit Entities,” for evaluating whether a transaction is reciprocal (i.e., an exchange transaction) or non reciprocal (i.e., a contribution) and for distinguishing between conditional and unconditional contributions. The ASU also clarified the guidance used by entities other than not-for-profits to identify and account for contributions made. Government grants are invoiced and revenue is recognized as milestones are achieved, conditions are removed and approval from grantor is obtained.

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, 2019, the Company reported $0.1 million in deferred revenue of which $0.1 million was earned and recognized as R&D, milestone and grant revenue during the year ended December 31, 2020. At December 31, 2020, the Company reported $1.6 in deferred revenue, in which $0.8 million is expected to be recognized during the three months ending March 31, 2021 and the remainder in the next twelve months.

In July 2020, the Company was awarded a grant of $0.6 million from BARDA to develop a SARS-CoV-2 Ag System. The Company earned $0.4 million for the year ended December 31,2020 and was recorded as government grant income.

In December 2020, the Company was awarded a grant of $12.7 million from BARDA to support the development and pursuit of FDA EUA for a rapid, multiplex DPP Respiratory Antigen Panel point-of-care test system. The Company earned $1.6 million for the year ended December 31,2020 and was recorded as government grant income..

(j) Loss Per Share:

Basic loss per share is computed by dividing net loss by the weighted average number of shares of the Company assumed to be outstanding during the period of computation. Diluted loss per share is computed using the treasury stock method if the additional shares are dilutive. For all periods presented, basic and diluted loss per share are the same as any additional shares would be anti-dilutive.

There were 603,531 and 545,986 restricted shares awards outstanding as of December 31, 2020 and 2019, respectively, that were not included in the calculation of diluted loss per share for the year ended December 31, 2020 and 2019, because their effect would have been anti-dilutive. There were 974,778 and 642,625 options outstanding as of December 31, 2020 and 2019 respectively, that were not included in the calculation of diluted loss per share for the twelve months ended December 31, 2020 and 2019, respectively, because their effect would have been anti-dilutive.

(k) Research and Development:

Research and Development (R&D) include product development, program management, clinical trials and regulatory costs and are expensed when 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 Company grants share options to employees, non-employee members of the Company’s board of directors and non-employee consultants as compensation for services performed. Employee and non-employee members of the board of directors’ awards of share-based compensation are accounted for in accordance with ASC 718, Compensation - Stock Compensation, or ASC 718. ASC 718 requires all share-based payments to employees and non-employee directors, including grants of share options, to be recognized in the consolidated statement of operations and comprehensive loss based on their grant date fair values.

Using this model, fair value is calculated based on assumptions with respect to (i) the fair value of the Company’s common stock on the grant date; (ii) expected volatility of the Company’s common stock price, (iii) the periods of time over which the optionees are expected to hold their options prior to exercise (expected term), (iv) expected dividend yield on the Company’s common stock, and (v) risk-free interest rates.

The grant date fair value of share options is estimated using the Black-Scholes option valuation model. The fair value of restricted stock and performance/restricted stock unit awards are determined on the date of grant or the date of issuance, as applicable.

The expected volatility is calculated based on historical data of the Company’s common stock. The expected dividend yield is zero as the Company has never paid dividends and does not currently anticipate paying any in the foreseeable future. Risk-free interest rates are based on quoted U.S. Treasury rates for securities with maturities approximating the option’s expected term. The expected term of share options granted to the optionees is determined using the expected life of the option.

Stock based compensation is reduced for actual forfeitures in the period in which the forfeiture occurs and generally recognized on a straight-line basis over the service period of the grant.

(m) Income 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) Goodwill and Indefinite-lived 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. 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.

Indefinite-lived intangible assets are tested for impairment annually during the first day of the fiscal fourth quarter of the year, and when events or changes in circumstances indicate the assets might be impaired. Impairment is indicated when the carrying value of the intangible asset exceeds its fair value.

(o) 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.

(p) Acquisition Costs:

Acquisition costs are expensed when incurred and include primarily professional services, related to acquisition activities.

(q) 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/losses are immaterial.

(r) Leases:

The Company accounts for leases in accordance with ASC 842. The Company determines if an arrangement is a lease at contract inception. A lease exists when a contract conveys the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. The definition of a lease embodies two conditions: (1) there is an identified asset in the contract that is land or a depreciable asset (i.e., property, plant, and equipment), and (2) the Company has the right to control the use of the identified asset. The Company accounts for the lease and non-lease components as a single lease component.

From time to time the Company enters into direct financing lease arrangements that include a lessee obligation to purchase the leased asset at the end of the lease term, a bargain purchase option, or provides for minimum lease payments with a present value of 90% or more of the fair value of the leased asset at the date of lease inception.

Operating leases where the Company is the lessee are included in right-of-use (“ROU”) assets and lease obligations are included on the Company’s consolidated balance sheets. The lease obligations are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date and subsequent reporting periods.

Finance leases where the Company is the lessee are included in ROU assets and lease obligations on the Company’s consolidated balance sheets. The lease obligations are initially measured in the same manner as for operating leases and are subsequently measured at amortized cost using the effective interest method.

Key estimates and judgments include how the Company determined (1) the discount rate used to discount the unpaid lease payments to present value, (2) lease term and (3) lease payments. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. As most of the Company’s leases where it is the lessee do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The Company uses the implicit rate when readily determinable.

The lease term for all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either a lessee option to extend (or not to terminate) the lease that is reasonably certain to be exercised, or an option to extend (or not to terminate) the lease controlled by the lessor.

The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, minus any accrued lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term.

For finance leases, the ROU asset is subsequently amortized using the straight-line method from the lease commencement date to the earlier of the end of its useful life or the end of the lease term unless the lease transfers ownership of the underlying asset, or the Company is reasonably certain to exercise an option to purchase the underlying asset. In those cases, the ROU asset is amortized over the useful life of the underlying asset. Amortization of the ROU asset is recognized and presented separately from interest expense on the lease liability.

The Company has elected not to recognize ROU assets and lease liabilities for all short-term leases that have a lease term of 12 months or less at lease commencement. Lease payments associated with short-term leases are recognized as an expense on a straight-line basis over the lease term.

(s) Recent Accounting Pronouncements Affecting the Company:

Recently Adopted

ASU 2020-10, Codification Improvements

In November 2020, the FASB issued ASU 2020-10, which clarifies various topics in the ASC, including the addition of existing disclosure requirements to the relevant disclosure sections. This update improves consistency by amending the ASC to include all disclosure guidance in the appropriate disclosure sections and clarifies application of various provisions in the ASC by amending and adding new headings, cross referencing to other guidance, and refining or correcting terminology. The Company has evaluated the effects of this standard and determined that the adoption did not have a material impact on the Company’s consolidated financial statements.

ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”)

In June 2016, the FASB issued ASU 2016-13. ASU 2016-13 provides guidance on measurement of credit losses on financial instruments that changes the impairment model for most financial assets and certain other instruments, including trade and other receivables, held-to-maturity debt securities and loans, and that requires entities to use a new, forward-looking “expected loss” model that is expected to generally result in the earlier recognition of allowances for losses. The Company adopted the standard effective January 1, 2020 and has evaluated the effects of this standard and determined that the adoption did not have a material impact on the Company’s consolidated financial statements.

ASU 2018-13, Fair Value Measurement - Disclosure Framework (Topic 820) (“ASU 2018-13”)

In August 2018, the FASB issued ASU 2018-13. ASU 2018-13 improves the disclosure requirements on fair value measurements. The updated guidance became effective for fiscal years beginning after December 15, 2019 including interim periods within those years. The Company adopted the standard effective January 1, 2020 and has evaluated the effects of this standard and determined that the adoption did not have a material impact on the Company’s consolidated financial statements.

ASU 2017-4, Intangibles - Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment (“ASU 2017-4”)

In January 2017, the FASB issued ASU 2017-4. ASU 2017-4 simplifies the subsequent measurement of goodwill and eliminates Step 2 from the goodwill impairment test. ASU 2017-4 is effective for annual and interim goodwill tests beginning after December 15, 2019. The Company adopted the standard effective January 1, 2020 and has evaluated the effects of this standard and determined that the adoption did not have a material impact on the Company’s consolidated financial statements.

Not Yet Adopted

ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes

In December 2019, the FASB issued ASU 2019-12. This standard simplifies the accounting for income taxes by eliminating certain exceptions to the guidance in Topic 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill and allocating consolidated income taxes to separate financial statements of entities not subject to income tax. ASU 2019-12 is effective for fiscal years beginning after December 15, 2020, with early adoption permitted. Upon adoption, the Company must apply certain aspects of this standard retrospectively for all periods presented while other aspects are applied on a modified retrospective basis through a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year of adoption. The Company will adopt the standard effective January 1, 2021 and has determined that the adoption will not have a material impact on the Company’s consolidated financial statements.

ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting

In March 2020, the FASB issued ASC Topic 848. ASC Topic 848 provides relief for impacted areas as it relates to impending reference rate reform. ASC Topic 848 contains optional expedients and exceptions for applying GAAP to debt arrangements, contracts, hedging relationships, and other areas or transactions that are impacted by reference rate reform. This guidance is effective upon issuance for all entities and elections of certain optional expedients are required to apply the provisions of the guidance. The Company will adopt the standard effective January 1, 2021 and has determined that the adoption will not have a material impact on the Company’s consolidated financial statements.

ASU 2020-06 - Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity

On August 5, 2020, the FASB issued ASU 2020-06, which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The ASU is part of the FASB’s simplification initiative, which aims to reduce unnecessary complexity in U.S. GAAP. ASU 2020-06 simplifies the guidance in U.S. GAAP on the issuer’s accounting for convertible debt instruments, requires entities to provide expanded disclosures about “the terms and features of convertible instruments” and how the instruments have been reported in the entity’s financial statements. It also removes from ASC 815-40-25-10 certain conditions for equity classification and amends certain guidance in ASC 260 on the computation of EPS for convertible instruments and contracts on an entity’s own equity. An entity can use either a full or modified retrospective approach to adopt the ASU’s guidance. The ASU’s amendments are effective for smaller public business entities fiscal years beginning after December 15, 2023. The Company continues to assess all potential impact of the standard and will disclose the nature and reason for any elections that the Company makes.

ACQUISITIONS

12 Months Ended

Dec. 31, 2020

ACQUISITIONS [Abstract]

ACQUISITIONS

NOTE 3 — ACQUISITIONS:

Orangelife

On November 25, 2019, pursuant to a quota purchase agreement, the Company acquired all of the outstanding shares of Orangelife Comercio e Industria Ltda., or Orangelife, a privately-held Brazilian company, which is an original equipment manufacturer of point-of-care tests approved by the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, or ANVISA) for infectious diseases that include HIV, Hepatitis C, Zika, Chikungunya, and Dengue Fever. Orangelife tests are manufactured in its Rio de Janeiro facility, which is ISO-certified and approved by ANVISA to produce Class II/III/IV medical devices. The purchase price includes the following consideration:

●

$150,000 in cash and 153,707 shares of common stock.

●

Issuance of 316,456 shares of common stock to the founder and former chief executive officer of Orangelife, based on the transfer and approval of registration of certain of the Company’s products in Brazil prior to November 25, 2022. All of the shares may be deliverable in the event of change in control of Chembio. The number of shares issued was subject to adjustments based upon Orangelife’s working capital at closing. The fair value of the shares on the date of the acquisition was recorded in equity and was valued at $1.2 million.

The purchase consideration is subject to routine post-closing adjustments and has been finalized as of December 31, 2020. The acquisition of Orangelife will allow us to expand our commercial presence by offering our products to the state, private, and pharmacy markets in Brazil, in addition to providing local support to our long time customer Bio-Manguinhos, the subsidiary of the Oswaldo Cruz Foundation (Fiocruz) that oversees development and production of vaccines, diagnostics, and biopharmaceuticals, primarily to meet the demands of Brazil’s national public health system. The results of Orangelife’s operations have been reflected in the consolidated financial statements since November 25, 2019.

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 November 25, 2019:

	Amount
Net current assets	$	320,293
Property, plant and equipment and other assets		226,035
Inventory		289,205
Goodwill		986,058
Deferred tax liability		(50,000	)
Other intangible assets (estimated useful life):
Trade name (0.5 years)		5,000
Customer contracts / relationships (5 years)		195,000
Total consideration	$	1,971,591

The Company calculated the fair value of the property, plant and equipment based on the net book value of Orangelife as that approximates fair value. The estimated fair value of the trade name, customer contracts/relationships and contingent earnouts were based on discounted cash flows using management estimates.

As a result of the consideration paid exceeding the fair value of the net assets acquired, goodwill in the amount of $986,058 was recorded in connection with this acquisition, none of which will be deductible for tax purposes. In addition, the Company recorded $200,000 in intangible assets associated with the addition of Orangelife’s trade name and customer base.

The following represents unaudited pro forma operating results for the year ended December 31, 2019 as if the operations of Orangelife had been included in the Company’s Consolidated Statements of Operations as of January 1, 2019. This pro forma financial information is unaudited and presented for illustrative purposes only and is not necessarily indicative of the operating results that would have occurred if the acquisition of Orangelife and the other transactions contemplated by this acquisition had been completed as of January 1, 2019, nor is it necessarily indicative of the future operating results of Chembio Diagnostics and Orangelife on a combined and consolidated basis.

	Unaudited Proforma December 31, 2019
Total revenues	$	35,157,248

Net loss	$	(13,654,001	)

Net loss per common share (basic and diluted)	$	(0.80	)

INVENTORIES

12 Months Ended

Dec. 31, 2020

INVENTORIES [Abstract]

INVENTORIES

NOTE 4 — INVENTORIES:

Net inventories consist of the following at December 31:

	December 31
	2020		2019
Raw Materials	$	5,955,215	$	2,901,319
Work in Process		2,549,516		793,343
Finished Goods		4,011,671		5,903,368
	$	12,516,402	$	9,598,030

FIXED ASSETS

12 Months Ended

Dec. 31, 2020

FIXED ASSETS [Abstract]

FIXED ASSETS

NOTE 5 — FIXED ASSETS:

Fixed assets consist of the following at December 31:

	December 31
	2020			2019
Machinery and Equipment	$	10,996,869		$	7,955,511
Furniture and Fixtures		25,418			21,477
Computer Equipment		446,300			416,359
Leasehold Improvements		3,158,074			3,038,469
Enterprise Business Systems		2,741,806			1,830,925
Subtotal:		17,368,467			13,262,741
Less: Accumulated Depreciation and Amortization		(8,680,064	)		(7,329,172	)
	$	8,688,403		$	5,933,569

Depreciation expense for the 2020 and 2019 years totaled $1,227,860 and $933,558, respectively.

As of December 31, 2020 and 2019, the Company has purchased manufacturing equipment that is not yet in use and therefore has not been depreciated, aggregating $3,011,273 and $1,400,181, respectively.

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

12 Months Ended

Dec. 31, 2020

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:

	December 31
	2020		2019
Accounts Payable - suppliers	$	5,727,781	$	3,144,098
Accrued Commissions & Royalties		807,708		931,760
Accrued Payroll		277,908		231,753
Accrued Vacation		417,238		410,199
Accrued Bonuses		1,193,985		215,000
Accrued Professional Fees		511,681		-
Accrued Expenses - Other		1,106,489		593,433
	$	10,042,790	$	5,526,243

REVENUE

12 Months Ended

Dec. 31, 2020

REVENUE [Abstract]

REVENUE

NOTE 7 — REVENUE:

Deferred 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.

From time to time the Company may receive prepayment from customers for products to be manufactured and shipped at future dates. Customer payments in advance of the applicable performance obligation are deferred and recognized in accordance with ASC 606.

As of December 31, 2020 and 2019, there were $1,606,997 and $125,000 unearned advanced revenues, respectively.

Disaggregation of Revenue

The following tables disaggregates total revenues for the period ending December 31, 2020:

	Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	24,767,149	$	-	$	24,767,149
R&D revenue		4,851,562		-		4,851,562
Government grant income		-		2,018,924		2,018,924
License and royalty revenue		832,562		-		832,562
	$	30,451,273	$	2,018,924	$	32,470,197

Exchange transactions are recognized in accordance with ASC 606, while non-exchange transactions are recognized in accordance with ASU 2018-08.

The following tables disaggregates total revenues for the period ending December 31, 2020 by region:

	Total
Africa	$	4,890,370
Asia		824,488
Europe & Middle East		9,905,437
Latin America		9,841,773
United States		7,008,129
	$	32,470,197

The following tables disaggregates total revenues for the period ending December 31, 2019:

	Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	28,844,997	$	-	$	28,844,997
R&D revenue		3,321,031		704,507		4,025,538
Government grant income		-		654,744		654,744
License and royalty revenue		938,753		-		938,753
	$	33,104,781	$	1,359,251	$	34,464,032

Exchange transactions are recognized in accordance with ASC 606, while non-exchange transactions are recognized in accordance with ASU 2018-08.

The following tables disaggregates total revenues for the period ending December 31, 2019 by region:

	Total
Africa	$	7,564,360
Asia		888,800
Europe & Middle East		6,498,995
Latin America		11,808,768
United States		7,703,109
	$	34,464,032

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-URI http://asc.fasb.org/topic&trid=49130388

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 10
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130551-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Subparagraph (b)
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-Name Accounting Standards Codification
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-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

+ Details

INCOME TAXES

12 Months Ended

Dec. 31, 2020

INCOME TAXES [Abstract]

INCOME TAXES

NOTE 8 — INCOME TAXES:

The components of (loss) before income taxes consisted of the following:

	Year Ending December 31,
	2020			2019
United States operations	$	(23,384,133	)	$	(12,504,780	)
International operations		(2,593,989	)		(1,670,641	)
(Loss) before taxes	$	(25,978,122	)	$	(14,175,421	)

The (benefit from) provision for income taxes for the years ended December 31, 2020 and 2019 is comprised of the following:

	Year Ending December 31,
	2020			2019
Current
Federal	$	(66,906	)	$	-
State		6,497			9,790
Foreign		-			3,633
Total current (benefit) provision		(60,409	)		13,423

Deferred
Federal		-			-
State		-			-
Foreign		(396,385	)		(513,715	)
Total deferred (benefit) provision		(396,385	)		(513,715	)

Total (benefit) provision	$	(456,794	)	$	(500,292	)

A reconciliation of the Federal statutory rate to the effective rate applicable to loss before income taxes is as follows:

	Year Ending December 31,
	2020			2019
Federal income tax at statutory rates		21.00	%		21.00	%
State income taxes, net of federal benefit		(0.02	)%		(0.05	)%
Nondeductible expenses		(0.19	)%		(1.00	)%
Foreign rate differential		0.47	%		0.45	%
Change in valuation allowance		(19.37	)%		(17.51	)%
Other		(0.13	)%		0.64	%
Income tax benefit		1.76	%		3.53	%

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 2020 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, 2020, the Company has post-change net operating loss carry-forwards of approximately $27,001,828 which expire between 2021 and 2037 and $35,840,768 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, 2020, which expire between 2021 and 2036.

The Company has state net operating loss carryforwards of approximately $3,511,090 which generally expire between 2035 and 2039. The Company has foreign net operating loss carryforwards of approximately $5,598,852 which generally expire between 2025 and 2026.

	2020			2019
Inventory reserves	$	461,709		$	196,193
Accrued expenses		130,291			105,323
Net operating loss carry-forwards		14,844,798			10,079,317
Research and development credit		1,696,870			1,679,495
Stock-based compensation		398,900			581,053
		602,187			-
Lease obligations		1,583,814			1,646,584
Depreciation		-			44,993
Total deferred tax assets		19,718,569			14,332,958

Right-of-use assets		(1,340,914	)		(1,538,129	)
Depreciation		(254,366	)		-
Intangibles		(821,363	)		(921,807	)
Total deferred tax liabilities		(2,416,643	)		(2,459,936	)

Net deferred tax assets before valuation allowance		17,301,926			11,873,022
Less valuation allowances		(17,371,867	)		(12,339,348	)
Net noncurrent deferred tax liabilities	$	(69,941	)	$	(466,326	)

The Company does not provide for U.S. income taxes on unremitted earnings of foreign subsidiaries as its present intention is to reinvest the unremitted earnings in the Company’s foreign operations. At December 31, 2020 there were no unremitted earnings of foreign subsidiaries.

Interest and penalties, if any, related to income tax liabilities are included in income tax expense. As of December 31, 2020, the Company does not have a liability for uncertain tax positions.

The Company files Federal and state income tax returns, Chembio Germany files in Germany, Chembio Brazil files in Brazil and Chembio Malaysia files in Malaysia and has been on tax holiday which expired on December 31, 2018. With few exceptions, tax years for fiscal 2017 through 2020 are open and potentially subject to examination by federal, state and foreign taxing authorities.

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act, (“CARES Act”), was enacted in response to the COVID-19 pandemic. The CARES Act, among other things, permits NOL carryovers and carrybacks to offset 100% of taxable income for taxable years beginning before 2021. In addition, the CARES Act allows NOLs incurred in tax years 2018, 2019, and 2020 to be carried back to each of the five preceding taxable years. In addition to the NOL changes, the CARES Act contains modifications on the limitation of business interest for tax years beginning in 2019 and 2020. The modifications to Section 163(j) increase the allowable business interest deduction from 30% of adjusted taxable income to 50% of adjusted taxable income. This modification did not effect the Company’s interest expense limitation. Overall the CARES ACT did not have a significant impact on the Company since it maintains a full valuation allowance.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References + Details

STOCKHOLDERS' EQUITY

12 Months Ended

Dec. 31, 2020

STOCKHOLDERS' EQUITY [Abstract]

STOCKHOLDERS' EQUITY

NOTE 9 — STOCKHOLDERS’ EQUITY:

(a)

Common Stock

During 2020, options to purchase 36,000 shares of the Company’s common stock were exercised for 5,528 shares of common stock, net of tax withholdings, at an exercise prices of $6.30. During 2019, options to purchase 54,343 shares of the Company’s common stock were exercised for 31,543 shares of common stock at an exercise prices ranging from $3.48 to $4.35 in each case by surrendering options or shares of common stock already owned.

In April 2020, the Company closed on an underwritten public offering of 619,593 shares of its common stock, including the underwriter’s exercise of its overallotment of 281,125 shares, at $11.75 per share. The net proceeds of the offering, after deducting the underwriter’s discounts and other offering expenses payable by the Company, was approximately $28.4 million.

(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 authorize the Company’s issuance of options, restricted stock, restricted stock units and other equity awards to officers, employees, directors, consultants and other service providers pursuant to the Company’s 2019 Omnibus Incentive Plan or otherwise.

(d)

Warrants

As of December 31, 2020, the Company has no warrants outstanding to purchase shares of common stock as further discussed in Note 14 – Warrants.

EQUITY INCENTIVE PLANS

12 Months Ended

Dec. 31, 2020

EQUITY INCENTIVE PLANS [Abstract]

EQUITY INCENTIVE PLANS

NOTE 10 — EQUITY 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, 2020, there were 694,000 options expired, forfeited or exercised, and at December 31, 2020, 56,000 options were outstanding. 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, 2020, there were there were 514,782 options expired, forfeited or exercised. At December 31, 2020, 264,157 options were outstanding and 0 Equity Award Units are available to be issued under the SIP14. Following the approval of the 2019 Plan (defined below), any Equity Award Units outstanding under the SIP14 remain subject to and be paid under the SIP14, and any shares subject to outstanding awards under the SIP14 that expire, terminate, or are surrendered or forfeited for any reason without issuance of shares automatically become available for issuance under the 2019 Plan.

Effective June 18, 2019, the Company’s stockholders voted to approve the 2019 Omnibus Incentive Plan (“2019 Plan”), with 2,400,000 shares of common stock available to be issued. In addition, shares of Common Stock underlying any outstanding award granted under the 2019 Plan that, following the effective date of the 2019 Plan, expires, or is terminated, surrendered or forfeited for any reason without issuance of such shares shall be available for the grant of new awards under the 2019 Plan. Under the terms of the 2019 Plan, 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 options, stock appreciation rights, restricted stock, restricted stock units, or other stock-based award’s under the 2019 Plan (collectively, “2019 Equity 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, 2020, 489,294 2019 Equity Units have been exercised or forfeited. At December 31, 2020, 1,024,563 2019 Equity Units were outstanding, and 1,506,226 2019 Equity Units were available to be awarded under the 2019 Plan.

The Company’s results for the years ended December 31, 2020 and 2019 include stock-based compensation expense totaling $1,098,698 and $1,655,900, respectively. Such amounts have been included in the Consolidated Statements of Operations within cost of product sales ($6,300 and $10,806, respectively), research and development ($386,016 and $228,597, respectively) and selling, general and administrative expenses ($706,382 and $1,416,497, respectively).

Stock option compensation expense in the years ended December 31, 2020 and 2019 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 stock compensation expense were $480,779 and $351,556 in December 31, 2020 and 2019, respectively.

The fair value of restricted stock and performance/restricted stock unit awards are determined on the date of grant or the date of issuance, as applicable. Stock-based compensation expense for stock options is calculated using the Black-Scholes valuation model. Stock based compensation is reduced for actual forfeitures in the period in which the forfeiture occurs and generally recognized on a straight-line basis over the service period of the grant. During the year ended December 31, 2020 and 2019, 486,488 and 0 shares of restricted stock were forfeited, respectively. During the year ended December 31, 2020 and 2019, 123,127 and 0 options were forfeited, respectively.

The weighted-average assumptions made in calculating the fair values of options are as follows for the respective years ended December 31:

	2020			2019
Expected term (in years)		6.29			n/a
Expected volatility		46.21	%		n/a
Expected dividend yield		0			n/a
Risk-free interest rate		1.30	%		n/a

The following table provides stock option activity for the years ended December 31, 2020 and 2019:

	Number of Shares	Weighted Average Exercise Price per Share		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value
Outstanding at December 31, 2019	642,625	$	5.79	2.57 years	$	285,925

Granted	726,280	$	2.59			-
Exercised	36,000	$	6.30			95,976
Forfeited/expired/cancelled	358,127	$	2.44			-
Outstanding at December 31, 2020	974,778	$	4.12	5.19 years	$	1,520,910

Exercisable at December 31, 2020	257,211	$	7.42	2.87 years	$	-

The following table summarizes information about stock options outstanding at December 31, 2020:

	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		636,364		6.21	$	2.36	$	1,520,910		-	$	-	$	-
2.8 to 4.59999		-		-		-		-		-		-		-
4.6 to 6.39999		83,664		4.25		5.53		-		39,961		5.53		-
6.4 to 8.19999		207,875		3.05		7.31		-		189,125		7.22		-
8.2 to 12		46,875		2.60		11.45		-		28,125		11.45		-
Total		974,778		5.19	$	4.12	$	1,520,910		257,211	$	7.42	$	-

As of December 31, 2020, there was $736,339 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 2.11 years. The total fair value of shares vested during the year ended December 31, 2020, was $326,630.

The following table summarizes information about restricted stock and restricted stock units outstanding as of December 31, 2020:

	Number of Shares & Units		Weighted Average Grant Date Fair Value
Unvested at December 31, 2019		545,986	$	7.47

Granted		656,759		2.75
Vested		112,726		5.63
Forfeited/expired/cancelled		486,488		6.43
Unvested at December 31, 2020		603,531		3.08

As of December 31, 2020, there was $1,215,441 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 1.8 years. Stock based compensation cost related to restricted stock and restricted stock units recognized during the years ended December 31, 2020 and 2019 was $617,919 and $1,394,814, respectively.

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY

12 Months Ended

Dec. 31, 2020

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract]

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY

NOTE 11 — 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 operating segment. Product revenue by geographic area are as follows:

	Year Ending December 31,
	2020		2019
Africa	$	4,890,370	$	7,564,360
Asia		824,488		888,800
Europe & Middle East		5,274,927		3,781,761
Latin America		9,841,772		11,808,767
United States		3,935,592		4,801,309
	$	24,767,149	$	28,844,997

Long-lived assets by geographic area are as follows:

	2020		2019
Asia	$	326,267	$	393,299
Europe & Middle East		147,692		165,029
Latin America		14,719		60,527
United States		8,199,725		5,314,715
	$	8,688,403	$	5,933,569

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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+ Details

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS

12 Months Ended

Dec. 31, 2020

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS [Abstract]

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS

NOTE 12 — COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS:

Employment Contracts:

The Company has multi-year contracts with two key employees. The contracts call for salaries presently aggregating $843,292 per year, and they expire in December 2021 and December 2022. The following table is a schedule of future minimum salary commitments:

2021	$	843,292
2022		460,000
2023		-

Benefit 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 $87,377 and $93,892 for the years ended December 31, 2020 and 2019, respectively.

Leases:

The Company leases facilities in New York, Germany, Malaysia, and Brazil, and certain equipment.

The Company’s facility leases generally include optional renewal periods. Upon entering into a new facility lease, the Company evaluates the leasehold improvements and regulatory requirements related to its operations in that location. To the extent that the initial lease term of the related facility lease is less than the useful life of the leasehold improvements and potential regulatory costs associated with moving the facility, the Company concludes that it is reasonably certain that a renewal option will be exercised, and thus that renewal period is included in the lease term and the related payments are reflected in the right-of-use asset and lease liability.

The Company’s leases generally include fixed rental payments with defined annual increases. While certain of the Company’s leases are gross leases, the majority of the Company’s leases are net leases in which the Company makes separate payments to the lessor based on the lessor’s property and casualty insurance costs, the property taxes assessed on the property, and a portion of the common area maintenance where applicable. The Company has elected the practical expedient not to separate lease and nonlease components for all of the Company’s facility leases.

The components of lease expense were as follows:

	Year Ended December 31, 2020		Year Ended December 31, 2019
Operating lease expense	$	1,669,105	$	1,655,573

Finance lease cost
Amortization of right-of-use assets	$	58,414	$	23,372
Interest on lease liabilities		19,986		7,892
Total finance lease expense	$	78,400	$	31,264

Supplemental cash flow and other information related to leases were as follows:

	Year Ended December 31, 2020		Year Ended December 31, 2019
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows for operating leases	$	1,139,944	$	632,952
Operating cash flows for finance leases		19,987		7,892
Financing cash flows for finance leases		51,166		19,875
Right-of-use assets obtained in exchange for lease obligations:				7,892
Operating leases	$	-	$	7,030,744
Finance leases		69,528		210,350

Supplemental balance sheet information related to leases was as follows:

	December 31, 2020			December 31, 2019
Finance Leases
Finance lease right of use asset	$	315,154		$	233,722
Accumulated depreciation		(82,020	)		(23,372	)
Finance lease right of use asset, net	$	233,134		$	210,350

Current portion of finance lease liability		58,877			41,894
Finance lease liability		185,239			171,953
Total finance lease liabilities	$	244,116		$	213,847

Weighted Average Remaining Lease Term
Operating leases	9.0 years			9.3 years
Finance leases	3.7 years			4.8 years

Weighted Average Discount Rate
Operating leases		8.58	%		8.67	%
Finance leases		8.18	%		7.00	%

During 2019, the Company executed an operating sublease related to its former Holbrook, New York facility. The sublease ran conterminously with the base lease in Holbrook, for which the Company was primarily responsible until the end of the lease term in April 2020.

Maturities of lease liabilities as of December 31, were as follows.

	December 31, 2020						December 31, 2019
	Operating Leases			Finance Leases			Operating Leases			Finance Leases
2021	$	1,209,787		$	76,904		$	1,205,161		$	55,536
2022		1,057,757			76,904			1,209,787			55,536
2023		1,026,272			76,904			1,057,757			55,536
2024		1,018,875			49,136			1,026,272			55,536
2025		1,049,442			5,755			1,018,875			27,767
Thereafter		4,724,445			-			5,773,887			-
Total lease payments	$	10,086,578		$	285,603		$	11,291,739		$	249,911
Less: imputed interest		(3,116,975	)		(41,487	)		(3,753,842	)		(36,064	)
Total	$	6,969,603		$	244,116		$	7,537,897		$	213,847

Economic Dependency:

The following table discloses product sales the Company had to customers that purchased in excess of 10% of the Company’s net product sales for the periods indicated:

	For The Years Ended										Accounts Receivable
	December 31, 2020					December 31, 2019					December 31, 2020		December 31, 2019
	Net Sales		% of Net Sales			Net Sales		% of Net Sales
Customer 1	$	6,224,737		25.1	%	$	11,263,573		39	%	$	522,218	$	941,962
Customer 2		2,955,312		11.9	%		5,782,543		20	%		1,987		16,033
Customer 3		2,956,945		11.9	%		*		*			*		*

Revenue includes product sales only, while accounts receivable reflects the total due from the customer, including freight.

The following table discloses purchases the Company made form vendors in excess of 10% of the Company’s net purchases for the periods indicated:

For The Years Ended

Accounts Payable

December 31, 2020

December 31, 2019

December

31, 2020

December

31, 2019

Purchases

% of Purc.

Purchases

% of Purc.

Vendor 1

2,222,182

13.0

222,588

In the tables above, an asterisk (*) indicates that indicates that sales, accounts receivable, purchases or accounts payable, as applicable to the tabular column, 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:

Employee Litigation

John J. Sperzel III, our former chief executive officer, filed suit in the United States District Court in Maine asserting a right to exercise certain options to purchase, for an aggregate exercise price of $943,126, a total of 266,666 shares of common stock that were vested when he resigned on January 3, 2020. Under their terms, those options were exercisable for a period of thirty days after his service to our company ended. The compensation committee of the board, acting in its discretion in accordance with the terms of the underlying equity incentive plans, has determined that Sperzel’s attempt to exercise the options following the thirty day period was not valid. The Court has dismissed Sperzel’s lawsuit for lack of personal jurisdiction in Maine. If Sperzel refiles the lawsuit in another jurisdiction, Chembio intends to vigorously defend against any claim by Mr. Sperzel that he continues to have a right to exercise any options.

Stockholder Litigation

Putative Stockholder Securities Class Action Litigation

As we reported previously, four purported securities class action lawsuits were filed by alleged stockholders of our Company in the United States District Court for the Eastern District of New York:

●

Sergey Chernysh v. Chembio Diagnostics, Inc., Richard L. Eberly, and Gail S. Page, filed on June 18, 2020, which we refer to as the Chernysh case;

●

James Gowen v. Chembio Diagnostics, Inc., Richard L. Eberly, and Gail S. Page, filed on June 22, 2020, which we refer to as the Gowen case;

●

Anthony Bailey v. Chembio Diagnostics, Inc. Richard J. Eberly, Gail S. Page, and Neil A. Goldman, filed on July 3, 2020, which we refer to as the Bailey case; and

●

Special Situations Fund III QP, L.P., Special Situations Cayman Fund, L.P., and Special Situations Private Equity Fund, L.P. v. Chembio Diagnostics, Inc., Richard Eberly, Gail S. Page, Robert W. Baird & Co. Inc. and Dougherty & Company LLC, filed August 17, 2020, which we refer to as the Special Situations Funds case.

The plaintiffs in each of the cases alleged claims under Section 10(b) of the Securities Exchange Act of 1934 (the “Exchange Act”), Rule 10b-5 thereunder, and Section 20(a) of the Exchange Act. Special Situations Fund III QP, L.P., Special Situations Cayman Fund, L.P., and Special Situations Private Equity Fund, L.P. (together, the “Special Situations Funds”) also asserted claims under Sections 11, 12(a)(2) and 15 of the Securities Act of 1933 (the “Securities Act”) relating to Chembio’s May 2020 public offering.

We and the plaintiffs entered into court-approved stipulations relieving the defendants of the obligation to respond to the complaints in these cases pending the designation of a lead plaintiff pursuant to the Private Securities Litigation Reform Act of 1995. Eight motions for appointment as lead plaintiff were filed by various prospective lead plaintiffs. However, all but two of these motions were withdrawn or otherwise abandoned, leaving before the Court two motions for appointment as lead plaintiff -- one filed by the Special Situations Funds, and one by Municipal Employees’ Retirement System of Michigan (“MERS”). By Order entered December 29, 2020, Magistrate Judge Lindsay consolidated the cases and appointed the Special Situations Funds and MERS as co-lead plaintiffs, and their respective counsel as co-lead counsel. The consolidated cases are now pending under the caption “In re Chembio Diagnostics, Inc. Securities Litigation.”

The Special Situations Funds and MERS (together “Lead Plaintiffs”) filed their Consolidated Amended Complaint (“CAC”) on February 12, 2021. In summary, the CAC purports to allege claims based on assertedly false and misleading statements and omissions concerning the performance of the DPP COVID-19 IgM/IgG System, as well as an asserted failure to timely disclose that the Emergency Use Authorization that had been granted by the Food and Drug Administration with respect to the System “was -- or was at an increased risk of -- being revoked.” The CAC names as defendants the Company, Richard L. Eberly, Gail S. Page, Neil A. Goldman, Javan Esfandiari, Katherine L. Davis, Dr. Mary Lake Polan, Dr. John Potthoff, and the underwriters for the Company’s May 2020 public offering, Robert W. Baird & Co., Inc. and Dougherty & Company LLC.

The CAC purports to assert five counts under the Securities Act and the Exchange Act of 1934. Counts I through III are brought under the Securities Act, allegedly on behalf of a purported class consisting of all persons who purchased Chembio common stock directly in or traceable to the Company’s May 2020 offering pursuant to the Company’s Form S-3 Registration Statement and its Prospectus and Prospectus Supplement dated May 7, 2020 (the “Securities Act Class”). Count I purports to allege a claim for violation of Section 11 of the Securities Act against all defendants other than Messrs. Eberly and Esfandiari. Count II purports to allege a claim for violation of Section 12 of the Securities Act against all defendants other than Messrs. Eberly and Esfandiari. Count III purports to allege a claim under Section 15 of the Securities Act against Ms. Davis, Dr. Polan, Dr. Potthoff, Ms. Page, and Mr. Goldman.

Counts IV and V are alleged claims under the Exchange Act on behalf of a purported class consisting of all persons who purchased Chembio securities on the open market between March 12, 2020 and June 16, 2020, inclusive (the “Exchange Act Class”). Count IV purports to allege a claim for violation of Section 10(b) of the Exchange Act and Rule 10b-5 thereunder against the Company, Mr. Eberly, Ms. Page, Mr. Goldman, and Mr. Esfandiari. Count V purports to allege a claim under Section 20(a) of the Exchange Act against Mr. Eberly, Ms. Page, Mr. Goldman, and Mr. Esfandiari.

Lead Plaintiffs seek, on behalf of the Securities Act Class and the Exchange Act Class, among other things, an award of damages in an amount to be proven at trial, as well as an award of reasonable costs, including attorneys’ fees and expenses, expert fees, pre-judgment and post-judgment interest, and such other relief as the court deems just and proper. The Lead Plaintiffs also seeks rescission “or a rescissory measure of damages” on behalf of the Securities Act Class as to Count II.

Pursuant to an Order entered by the Court on January 29, 2021, any defendant wishing to move against the amended complaint was required to file, by February 18, 2021, a letter requesting a pre-motion conference. On that date, the defendants submitted letters to the Court requesting a pre-motion conference regarding anticipated motions to dismiss the CAC, and Lead Plaintiffs responded on February 24, 2021. In its January 29, 2021 Order, the Court indicated that it would consider a briefing schedule on motions to dismiss after it had received and reviewed the parties’ correspondence.

On March 5, 2021, the Court entered an Order in which the Court advised the parties that it had determined that a pre-motion conference was not necessary and established a briefing schedule on the defendants’ anticipated motions to dismiss. Pursuant to that schedule, defendants’ motions and supporting papers are due to be filed no later than March 19, 2021, the Lead Plaintiffs’ opposition papers are due to be filed no later than April 2, 2021, and the defendants’ reply papers are due to be filed no later than April 9, 2021. We have agreed with Plaintiffs’ counsel to a modification of the schedule such that defendants’ motions and supporting papers would be due to be filed no later than March 26, 2021, the Lead Plaintiffs’ opposition papers would be due to be filed no later than April 16, 2021, and the defendants’ reply papers would be due to be filed no later than April 30, 2021. This schedule modification is subject to the Court’s approval.

Putative Stockholder Derivative Litigation

On September 11, 2020, a putative stockholder derivative action was filed purportedly on our Company’s behalf in the United States District Court for the Eastern District of New York captioned Karen Wong, derivatively on behalf of Chembio Diagnostics, Inc., Plaintiff v. Richard L. Eberly, Gail S. Page, Neil A. Goldman, Javan Esfandiari, Katherine L. Davis, Mary Lake Polan, and John G. Potthoff, Defendants, and Chembio Diagnostics, Inc., Nominal Defendant, which we refer to as the Wong complaint. The Wong complaint purports to assert a claim for violation of Section 14(a) of the Exchange Act and Rule 14a-9 thereunder based on ostensibly false and misleading statements and omissions concerning our rapid COVID-19 antibody test in the proxy statement disseminated in advance of our Annual Meeting of Stockholders held on July 28, 2020. The Wong complaint also asserts claims against the individual defendants for purported breaches of fiduciary duties owed to our Company, as well as unjust enrichment.

The Wong complaint requests a declaration that the individual defendants have breached or aided and abetted the breach of their fiduciary duties to our Company, an award of damages to our Company, restitution, and an award of the plaintiff’s costs and disbursements in the action, including reasonable attorneys’ and experts’ fees, costs and expenses, and improvements to our Company’s corporate governance and internal procedures regarding compliance with laws. Pursuant to a stipulation by which the individual defendants in the Wong action agreed to waive service of process, the Court ordered that the time for defendants to answer or otherwise respond to the complaint be extended to November 19, 2020. The parties subsequently entered into a stipulation for a stay of proceedings in the Wong action pending final disposition of motions to dismiss the pending putative class action litigation, subject to certain conditions. The Court entered an order granting the requested stay on November 3, 2020.

Commercial Litigation

Chembio Diagnostic Systems Inc. (“Chembio”) and BioSure (UK) Ltd (“BioSure”) entered into the BioSure Sure Check® HIV 1/2 Assay OTC Agreement dated April 2, 2014, and as subsequently amended (the “Distribution Agreement”). Pursuant to the Distribution Agreement, BioSure acquired the right to sell bundled products in the UK containing Chembio’s Sure Check® HIV 1/2 pouched tests. The Distribution Agreement terminated on April 1, 2019. On September 16, 2019, Chembio initiated arbitration in New York, USA. Chembio alleges that BioSure (1) breached various provisions of the Distribution Agreement, (2) misappropriated Chembio’s trade secrets, (3) engaged in deceptive business acts and practices, and (4) breached the implied covenant of good faith and fair dealing. On November 23, 2020, BioSure requested leave to file a counterclaim seeking recession of the Distribution Agreement based on alleged fraudulent concealment by Chembio. Chembio opposed BioSure’s request for leave to file the counterclaim on procedural and substantive grounds, and on December 11, 2020 the Tribunal denied the request for leave to file the counterclaim. The Tribunal’s denial was without prejudice to BioSure’s ability to assert its claim in a separate proceeding. BioSure continues to deny the relief sought and alleges certain statements Chembio made to third parties about the Distribution Agreement were in bad faith and are a defense to Chembio’s claims. BioSure also asserts that certain alleged misrepresentations entitle BioSure to “set off” any award Chembio might receive from the Tribunal. The parties have completed discovery, and submitted their first pre-hearing submissions. Chembio intends to vigorously pursue its claims in the arbitration. The final merits hearing is scheduled for April 2021. At this stage in the litigation, we are not able to predict the probability of a favorable or unfavorable outcome.

Governmental Regulation:

All of the Company’s existing and proposed diagnostic products are regulated by the U.S. Food and Drug Administration, U.S. Department of Agriculture, certain U.S., state and local agencies, and/or comparable regulatory bodies in other countries. Most aspects of development, production, and marketing, including product testing, authorizations to market, labeling, promotion, manufacturing, and record keeping, are subject to regulatory review. After marketing approval has been granted, Chembio must continue to comply with governmental regulations. Failure to comply with applicable requirements can lead to sanctions, including withdrawal of products from the market, recalls, refusal to authorize government contracts, product seizures, civil money penalties, injunctions, and criminal prosecution.

LONG-TERM DEBT	12 Months Ended
LONG-TERM DEBT	Dec. 31, 2020
LONG-TERM DEBT [Abstract]
LONG-TERM DEBT	NOTE 13 — LONG-TERM DEBT: 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 payments 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 paid 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. The remaining balance was entirely short-term as of December 31, 2019. This balance was fully paid during 2020. On September 3, 2019, the Company entered into a Credit Agreement and Guaranty (the “Credit Agreement”) with Perceptive Credit Holdings II, LP (the “Lender”). The Credit Agreement provides for a $20,000,000 senior secured term loan credit facility, which was drawn in full on September 4, 2019. Under the terms of the Credit Agreement, the Company may use the proceeds (i) for general working capital purposes and other permitted corporate purposes, (ii) to refinance certain of the Company’s existing indebtedness and (iii) to pay fees, costs and expenses incurred in connection with the Credit Agreement, including the Lender’s closing cost amount of $550,000, which was netted from the proceeds, and a financing fee of $600,000 (3.0% of gross proceeds) payable to Craig-Hallum Capital Group LLC, the Company’s financial advisor for the financing. Principal outstanding under the Credit Agreement bears interest at a rate per annum equal to the sum of (a) the greater of the one-month London Interbank Offered Rate and 2.5% plus (b) 8.75%. At any time at which an event of default has occurred and is continuing, the interest rate will increase by 4.0%. Accrued interest is payable on a monthly basis. On December 31, 2020 the interest rate was 11.25%. No principal repayments are due under the Credit Agreement prior to September 30, 2022, unless the Company elects to prepay principal or principal is accelerated pursuant to an event of default identified in the Credit Agreement. Principal installments in the amount of $300,000 are payable on the last day of each of the eleven months from September 2022 through July 2023, and all remaining principal is payable at maturity on September 3, 2023. The Company may prepay outstanding principal from time to time, subject to payment of a premium on the prepaid principal amount equal to 10% through September 3, 2020, 8% from September 4, 2020 through September 3, 2021, and 4% from September 4, 2021 through September 3, 2022. No premium will be due with respect to any prepayment made on or after September 4, 2022. Chembio’s obligations under the Credit Agreement are secured by a first priority, perfected lien on substantially all of its property and assets, including its equity interests in subsidiaries. As of December 31, 2020, the loan balance, net of unamortized discounts and debt issuance costs, was $18.2 million, and Chembio was in compliance with its loan covenants.

WARRANTS

12 Months Ended

Dec. 31, 2020

WARRANTS [Abstract]

WARRANTS

NOTE 14 — WARRANTS:

In connection with entering into the Credit Agreement, on September 3, 2019, the Company issued to the Lender a seven-year warrant (the “Warrant”) to purchase up to 550,000 shares of the Company’s common stock at a per-share exercise price of $5.22. The Warrant was exercisable for cash or on a net, or “cashless,” basis, and the exercise price of the Warrant was subject to price-based, weighted-average antidilution adjustments for one year after issuance.

The Warrant was evaluated by the Company and classified within stockholder’s equity. Its fair value was estimated using a Black-Scholes option-pricing model using the assumptions below.

Stock price on issuance date	$	5.40
Strike Price	$	5.22
Risk-free interest rate		1.45	%
Volatility		43.65	%
Expected life	7 years

The fair value of the Warrant was determined to be approximately $1.4 million at $2.49 per share.

As of December 31, 2020, the Warrant was fully exercised.

GOODWILL AND INTANGIBLE ASSETS

12 Months Ended

Dec. 31, 2020

GOODWILL AND INTANGIBLE ASSETS [Abstract]

GOODWILL AND INTANGIBLE ASSETS

NOTE 15 - GOODWILL AND INTANGIBLE ASSETS:

For the years ended December 31, 2020 and 2019, there was no impairment of goodwill and other intangible assets.

Following is a table that reflects changes in Goodwill:

Beginning balance January 1, 2020	$	5,872,690
Changes in foreign currency exchange rate		91,054
Balance at December 31, 2020	$	5,963,744

Intangible assets consist of the following at:

		December 31, 2020			December 31, 2019
	Weighted Average Remaining Life	Cost	Accumulated Amortization	Net Book Value	Cost	Accumulated Amortization	Net Book Value
Intellectual property	5	$1,638,699	$472,190	$1,166,509	$1,418,681	$299,232	$1,119,449
Developed technology	5	2,102,526	594,186	1,508,340	1,922,682	266,550	1,656,132
Customer contracts/relationships	6	1,323,424	423,093	900,331	1,325,521	270,902	1,054,619
Trade names	7	115,318	44,512	70,806	114,946	30,794	84,152
		$5,179,967	$1,533,981	$3,645,986	$4,781,830	$867,478	$3,914,352

Amortization expense for the year ended December 31, 2020 and 2019 was $588,962 and $515,263, respectively, and is recorded within COGS, R&D and Selling, General and Administrative expenses. Amortization expense, subject to changes in currency exchange rates, is expected to be approximately $617,000 per year from 2021 through 2025, and total $561,000 million for all of the years thereafter.

SUBSEQUENT EVENTS	12 Months Ended
SUBSEQUENT EVENTS	Dec. 31, 2020
SUBSEQUENT EVENTS [Abstract]
SUBSEQUENT EVENTS	NOTE 16 — SUBSEQUENT EVENTS: Restructuring On January 14, 2021, the Company’s Board of Directors (the “Board”) approved a restructuring plan (“2021 Plan”) to better align its business priorities. The Plan comprises the termination of employees primarily in the manufacturing department. These actions were intended to better align the Company’s cost structure with the skills and resources required to more effectively pursue opportunities in the marketplace and execute the Company’s long-term growth strategy. Costs associated with the 2021 Plan are primarily related to Severance and Legal costs. Severance payouts are expected to be substantially completed by the end of the six months ending June 30, 2021. Under the 2021 Plan, the Company expects to incur pre-tax charges between approximately $0.1 million and $0.2 million.

SIGNIFICANT ACCOUNTING POLICIES (Policies)

12 Months Ended

Dec. 31, 2020

SIGNIFICANT ACCOUNTING POLICIES [Abstract]

Basis of Presentation

(a) Basis of Presentation:

The accompanying consolidated financial statements include the accounts of Chembio and its subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.

Certain amounts related to other government income in the prior period financial statements have been reclassified to conform to the presentation of the current period financial statements.

Use of Estimates

(b) Use of Estimates:

Fair Value of Financial Instruments

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:

Concentrations of Credit Risk

(e) Concentrations of Credit Risk:

Inventory

(f) Inventory:

Fixed Assets

(g) Fixed Assets:

Valuation of Long-Lived Assets and Intangible Assets

(h) Valuation of Long-Lived Assets and Intangible Assets:

Revenue Recognition

(i) Revenue Recognition:

Product Revenue

Reserves for Discounts and Allowances

License and Royalty Revenues

R&D Revenue

Government Grant Income

Contract Liabilities

Loss Per Share

(j) Loss Per Share:

Research and Development

(k) Research and Development:

Stock-Based Compensation

(l) Stock-Based Compensation:

Stock based compensation is reduced for actual forfeitures in the period in which the forfeiture occurs and generally recognized on a straight-line basis over the service period of the grant.

Income Taxes

(m) Income Taxes:

Goodwill and Indefinite-lived Intangible Assets

(n) Goodwill and Indefinite-lived Intangible Assets:

Allowance for Doubtful Accounts

(o) Allowance for Doubtful Accounts:

Acquisition Costs

(p) Acquisition Costs:

Acquisition costs are expensed when incurred and include primarily professional services, related to acquisition activities.

Foreign Currency Translation

(q) Foreign Currency Translation:

Leases

(r) Leases:

Recent Accounting Pronouncements Affecting the Company

(s) Recent Accounting Pronouncements Affecting the Company:

Recently Adopted

ASU 2020-10, Codification Improvements

ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”)

ASU 2018-13, Fair Value Measurement - Disclosure Framework (Topic 820) (“ASU 2018-13”)

ASU 2017-4, Intangibles - Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment (“ASU 2017-4”)

Not Yet Adopted

ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes

ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting

ACQUISITIONS (Tables) - Orangelife [Member]

12 Months Ended

Dec. 31, 2020

Business Acquisition [Line Items]

Fair Values of Assets Acquired and Liabilities Assumed

	Amount
Net current assets	$	320,293
Property, plant and equipment and other assets		226,035
Inventory		289,205
Goodwill		986,058
Deferred tax liability		(50,000	)
Other intangible assets (estimated useful life):
Trade name (0.5 years)		5,000
Customer contracts / relationships (5 years)		195,000
Total consideration	$	1,971,591

Unaudited Pro forma Operating Results

	Unaudited Proforma December 31, 2019
Total revenues	$	35,157,248

Net loss	$	(13,654,001	)

Net loss per common share (basic and diluted)	$	(0.80	)

INVENTORIES (Tables)

12 Months Ended

Dec. 31, 2020

INVENTORIES [Abstract]

Inventories

Net inventories consist of the following at December 31:

	December 31
	2020		2019
Raw Materials	$	5,955,215	$	2,901,319
Work in Process		2,549,516		793,343
Finished Goods		4,011,671		5,903,368
	$	12,516,402	$	9,598,030

FIXED ASSETS (Tables)

12 Months Ended

Dec. 31, 2020

FIXED ASSETS [Abstract]

Fixed Assets

Fixed assets consist of the following at December 31:

	December 31
	2020			2019
Machinery and Equipment	$	10,996,869		$	7,955,511
Furniture and Fixtures		25,418			21,477
Computer Equipment		446,300			416,359
Leasehold Improvements		3,158,074			3,038,469
Enterprise Business Systems		2,741,806			1,830,925
Subtotal:		17,368,467			13,262,741
Less: Accumulated Depreciation and Amortization		(8,680,064	)		(7,329,172	)
	$	8,688,403		$	5,933,569

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Tables)

12 Months Ended

Dec. 31, 2020

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract]

Accounts Payable and Accrued Liabilities

Accounts payable and accrued liabilities consist of the following at December 31:

	December 31
	2020		2019
Accounts Payable - suppliers	$	5,727,781	$	3,144,098
Accrued Commissions & Royalties		807,708		931,760
Accrued Payroll		277,908		231,753
Accrued Vacation		417,238		410,199
Accrued Bonuses		1,193,985		215,000
Accrued Professional Fees		511,681		-
Accrued Expenses - Other		1,106,489		593,433
	$	10,042,790	$	5,526,243

REVENUE (Tables)

12 Months Ended

Dec. 31, 2020

REVENUE [Abstract]

Disaggregation of Revenue

The following tables disaggregates total revenues for the period ending December 31, 2020:

	Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	24,767,149	$	-	$	24,767,149
R&D revenue		4,851,562		-		4,851,562
Government grant income		-		2,018,924		2,018,924
License and royalty revenue		832,562		-		832,562
	$	30,451,273	$	2,018,924	$	32,470,197

Exchange transactions are recognized in accordance with ASC 606, while non-exchange transactions are recognized in accordance with ASU 2018-08.

The following tables disaggregates total revenues for the period ending December 31, 2020 by region:

	Total
Africa	$	4,890,370
Asia		824,488
Europe & Middle East		9,905,437
Latin America		9,841,773
United States		7,008,129
	$	32,470,197

The following tables disaggregates total revenues for the period ending December 31, 2019:

	Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	28,844,997	$	-	$	28,844,997
R&D revenue		3,321,031		704,507		4,025,538
Government grant income		-		654,744		654,744
License and royalty revenue		938,753		-		938,753
	$	33,104,781	$	1,359,251	$	34,464,032

Exchange transactions are recognized in accordance with ASC 606, while non-exchange transactions are recognized in accordance with ASU 2018-08.

The following tables disaggregates total revenues for the period ending December 31, 2019 by region:

	Total
Africa	$	7,564,360
Asia		888,800
Europe & Middle East		6,498,995
Latin America		11,808,768
United States		7,703,109
	$	34,464,032

INCOME TAXES (Tables)

12 Months Ended

Dec. 31, 2020

INCOME TAXES [Abstract]

Components of (Loss) Before Income Taxes

The components of (loss) before income taxes consisted of the following:

	Year Ending December 31,
	2020			2019
United States operations	$	(23,384,133	)	$	(12,504,780	)
International operations		(2,593,989	)		(1,670,641	)
(Loss) before taxes	$	(25,978,122	)	$	(14,175,421	)

(Benefit) Provision for Income Taxes

The (benefit from) provision for income taxes for the years ended December 31, 2020 and 2019 is comprised of the following:

	Year Ending December 31,
	2020			2019
Current
Federal	$	(66,906	)	$	-
State		6,497			9,790
Foreign		-			3,633
Total current (benefit) provision		(60,409	)		13,423

Deferred
Federal		-			-
State		-			-
Foreign		(396,385	)		(513,715	)
Total deferred (benefit) provision		(396,385	)		(513,715	)

Total (benefit) provision	$	(456,794	)	$	(500,292	)

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,
	2020			2019
Federal income tax at statutory rates		21.00	%		21.00	%
State income taxes, net of federal benefit		(0.02	)%		(0.05	)%
Nondeductible expenses		(0.19	)%		(1.00	)%
Foreign rate differential		0.47	%		0.45	%
Change in valuation allowance		(19.37	)%		(17.51	)%
Other		(0.13	)%		0.64	%
Income tax benefit		1.76	%		3.53	%

Deferred Tax Assets and Liabilities

	2020			2019
Inventory reserves	$	461,709		$	196,193
Accrued expenses		130,291			105,323
Net operating loss carry-forwards		14,844,798			10,079,317
Research and development credit		1,696,870			1,679,495
Stock-based compensation		398,900			581,053
		602,187			-
Lease obligations		1,583,814			1,646,584
Depreciation		-			44,993
Total deferred tax assets		19,718,569			14,332,958

Right-of-use assets		(1,340,914	)		(1,538,129	)
Depreciation		(254,366	)		-
Intangibles		(821,363	)		(921,807	)
Total deferred tax liabilities		(2,416,643	)		(2,459,936	)

Net deferred tax assets before valuation allowance		17,301,926			11,873,022
Less valuation allowances		(17,371,867	)		(12,339,348	)
Net noncurrent deferred tax liabilities	$	(69,941	)	$	(466,326	)

EQUITY INCENTIVE PLANS (Tables)

12 Months Ended

Dec. 31, 2020

EQUITY 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:

	2020			2019
Expected term (in years)		6.29			n/a
Expected volatility		46.21	%		n/a
Expected dividend yield		0			n/a
Risk-free interest rate		1.30	%		n/a

Stock Option Activity

The following table provides stock option activity for the years ended December 31, 2020 and 2019:

	Number of Shares	Weighted Average Exercise Price per Share		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value
Outstanding at December 31, 2019	642,625	$	5.79	2.57 years	$	285,925

Granted	726,280	$	2.59			-
Exercised	36,000	$	6.30			95,976
Forfeited/expired/cancelled	358,127	$	2.44			-
Outstanding at December 31, 2020	974,778	$	4.12	5.19 years	$	1,520,910

Exercisable at December 31, 2020	257,211	$	7.42	2.87 years	$	-

Stock Options Outstanding

The following table summarizes information about stock options outstanding at December 31, 2020:

	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		636,364		6.21	$	2.36	$	1,520,910		-	$	-	$	-
2.8 to 4.59999		-		-		-		-		-		-		-
4.6 to 6.39999		83,664		4.25		5.53		-		39,961		5.53		-
6.4 to 8.19999		207,875		3.05		7.31		-		189,125		7.22		-
8.2 to 12		46,875		2.60		11.45		-		28,125		11.45		-
Total		974,778		5.19	$	4.12	$	1,520,910		257,211	$	7.42	$	-

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, 2020:

	Number of Shares & Units		Weighted Average Grant Date Fair Value
Unvested at December 31, 2019		545,986	$	7.47

Granted		656,759		2.75
Vested		112,726		5.63
Forfeited/expired/cancelled		486,488		6.43
Unvested at December 31, 2020		603,531		3.08

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY (Tables)

12 Months Ended

Dec. 31, 2020

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract]

Product Revenue by Geographic Area

	Year Ending December 31,
	2020		2019
Africa	$	4,890,370	$	7,564,360
Asia		824,488		888,800
Europe & Middle East		5,274,927		3,781,761
Latin America		9,841,772		11,808,767
United States		3,935,592		4,801,309
	$	24,767,149	$	28,844,997

Long-lived Assets by Geographic Area

Long-lived assets by geographic area are as follows:

	2020		2019
Asia	$	326,267	$	393,299
Europe & Middle East		147,692		165,029
Latin America		14,719		60,527
United States		8,199,725		5,314,715
	$	8,688,403	$	5,933,569

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS (Tables)

12 Months Ended

Dec. 31, 2020

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS [Abstract]

Future Minimum Salary Commitment

2021	$	843,292
2022		460,000
2023		-

Components of Lease Expense

The components of lease expense were as follows:

	Year Ended December 31, 2020		Year Ended December 31, 2019
Operating lease expense	$	1,669,105	$	1,655,573

Finance lease cost
Amortization of right-of-use assets	$	58,414	$	23,372
Interest on lease liabilities		19,986		7,892
Total finance lease expense	$	78,400	$	31,264

Supplemental Cash Flow and Other Information Related to Leases

Supplemental cash flow and other information related to leases were as follows:

	Year Ended December 31, 2020		Year Ended December 31, 2019
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows for operating leases	$	1,139,944	$	632,952
Operating cash flows for finance leases		19,987		7,892
Financing cash flows for finance leases		51,166		19,875
Right-of-use assets obtained in exchange for lease obligations:				7,892
Operating leases	$	-	$	7,030,744
Finance leases		69,528		210,350

Supplemental Balance Sheet Information Related to Leases

Supplemental balance sheet information related to leases was as follows:

	December 31, 2020			December 31, 2019
Finance Leases
Finance lease right of use asset	$	315,154		$	233,722
Accumulated depreciation		(82,020	)		(23,372	)
Finance lease right of use asset, net	$	233,134		$	210,350

Current portion of finance lease liability		58,877			41,894
Finance lease liability		185,239			171,953
Total finance lease liabilities	$	244,116		$	213,847

Weighted Average Remaining Lease Term
Operating leases	9.0 years			9.3 years
Finance leases	3.7 years			4.8 years

Weighted Average Discount Rate
Operating leases		8.58	%		8.67	%
Finance leases		8.18	%		7.00	%

Maturities of Lease Liabilities

Maturities of lease liabilities as of December 31, were as follows.

	December 31, 2020						December 31, 2019
	Operating Leases			Finance Leases			Operating Leases			Finance Leases
2021	$	1,209,787		$	76,904		$	1,205,161		$	55,536
2022		1,057,757			76,904			1,209,787			55,536
2023		1,026,272			76,904			1,057,757			55,536
2024		1,018,875			49,136			1,026,272			55,536
2025		1,049,442			5,755			1,018,875			27,767
Thereafter		4,724,445			-			5,773,887			-
Total lease payments	$	10,086,578		$	285,603		$	11,291,739		$	249,911
Less: imputed interest		(3,116,975	)		(41,487	)		(3,753,842	)		(36,064	)
Total	$	6,969,603		$	244,116		$	7,537,897		$	213,847

Customer and Purchase Concentration Risks

The following table discloses product sales the Company had to customers that purchased in excess of 10% of the Company’s net product sales for the periods indicated:

	For The Years Ended										Accounts Receivable
	December 31, 2020					December 31, 2019					December 31, 2020		December 31, 2019
	Net Sales		% of Net Sales			Net Sales		% of Net Sales
Customer 1	$	6,224,737		25.1	%	$	11,263,573		39	%	$	522,218	$	941,962
Customer 2		2,955,312		11.9	%		5,782,543		20	%		1,987		16,033
Customer 3		2,956,945		11.9	%		*		*			*		*

Revenue includes product sales only, while accounts receivable reflects the total due from the customer, including freight.

The following table discloses purchases the Company made form vendors in excess of 10% of the Company’s net purchases for the periods indicated:

For The Years Ended

Accounts Payable

December 31, 2020

December 31, 2019

December

31, 2020

December

31, 2019

Purchases

% of Purc.

Purchases

% of Purc.

Vendor 1

2,222,182

13.0

222,588

WARRANTS (Tables)

12 Months Ended

Dec. 31, 2020

WARRANTS [Abstract]

Warrants Fair Value Assumptions

The Warrant was evaluated by the Company and classified within stockholder’s equity. Its fair value was estimated using a Black-Scholes option-pricing model using the assumptions below.

Stock price on issuance date	$	5.40
Strike Price	$	5.22
Risk-free interest rate		1.45	%
Volatility		43.65	%
Expected life	7 years

GOODWILL AND INTANGIBLE ASSETS (Tables)

12 Months Ended

Dec. 31, 2020

GOODWILL AND INTANGIBLE ASSETS [Abstract]

Changes in Goodwill

Following is a table that reflects changes in Goodwill:

Beginning balance January 1, 2020	$	5,872,690
Changes in foreign currency exchange rate		91,054
Balance at December 31, 2020	$	5,963,744

Intangible Assets

Intangible assets consist of the following at:

		December 31, 2020			December 31, 2019
	Weighted Average Remaining Life	Cost	Accumulated Amortization	Net Book Value	Cost	Accumulated Amortization	Net Book Value
Intellectual property	5	$1,638,699	$472,190	$1,166,509	$1,418,681	$299,232	$1,119,449
Developed technology	5	2,102,526	594,186	1,508,340	1,922,682	266,550	1,656,132
Customer contracts/relationships	6	1,323,424	423,093	900,331	1,325,521	270,902	1,054,619
Trade names	7	115,318	44,512	70,806	114,946	30,794	84,152
		$5,179,967	$1,533,981	$3,645,986	$4,781,830	$867,478	$3,914,352

DESCRIPTION OF BUSINESS (Details) - USD ($)	Dec. 02, 2020	Jul. 06, 2020
DESCRIPTION OF BUSINESS [Abstract]
Grants received from Department of Health and Human Services		$ 628,071
Grants received from BARDA	$ 12,691,726

SIGNIFICANT ACCOUNTING POLICIES, Part 1 (Details) - USD ($)	1 Months Ended		3 Months Ended	12 Months Ended
	Dec. 31, 2020	Jul. 31, 2020	Mar. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	$ 23,066,301			$ 23,066,301	$ 18,271,352
Cash and Cash Equivalents [Abstract]
Restricted cash	1,000,000			1,000,000	0
Valuation of Long-Lived Assets and Intangible Assets [Abstract]
Goodwill impairment loss				0	0
Disaggregation of Revenue [Abstract]
Total revenues				32,470,197	34,464,032
Contract Liabilities [Abstract]
Deferred revenue	1,606,997			1,606,997	125,000
Earned grant revenue				$ 100,000
Term over which revenue will be recognized				12 months
SARS-CoV-2 Ag System [Member]
Contract Liabilities [Abstract]
Maximum amount of development agreement		$ 600,000
Multiplex DPP Respiratory Antigen Panel Point-of-care Test system [Member]
Contract Liabilities [Abstract]
Maximum amount of development agreement	12,700,000
Forecast [Member]
Contract Liabilities [Abstract]
Earned grant revenue			$ 800,000
Government Grant Income [Member]
Disaggregation of Revenue [Abstract]
Total revenues				$ 2,018,924	654,744
Government Grant Income [Member] \| SARS-CoV-2 Ag System [Member]
Disaggregation of Revenue [Abstract]
Total revenues				400,000
Government Grant Income [Member] \| Multiplex DPP Respiratory Antigen Panel Point-of-care Test system [Member]
Disaggregation of Revenue [Abstract]
Total revenues				1,600,000
Level 2 [Member]
Fair Value of Financial Instruments [Abstract]
Fair value of total debt	20,000,000			20,000,000	20,000,000
Carrying value	18,200,000			18,200,000	17,600,000
Money Market Funds [Member] \| Level 1 [Member]
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	$ 14,800,000			$ 14,800,000	$ 16,000,000.0
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

SIGNIFICANT ACCOUNTING POLICIES, Part 2 (Details) - shares	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Leases [Abstract]
Percentage of minimum lease payment for fair value	90.00%
Lease term	12 months
Options [Member]
Loss Per Share [Abstract]
Antidilutive securities excluded from calculation of diluted earnings per share (in shares)	974,778	642,625
Restricted Stock [Member]
Loss Per Share [Abstract]
Antidilutive securities excluded from calculation of diluted earnings per share (in shares)	603,531	545,986

ACQUISITIONS, Orangelife (Details) - USD ($)		12 Months Ended
ACQUISITIONS, Orangelife (Details) - USD ($)	Nov. 25, 2019	Dec. 31, 2019	Dec. 31, 2020
Fair values of Assets Acquired and Liabilities Assumed [Abstract]
Goodwill		$ 5,872,690	$ 5,963,744
Unaudited Pro Forma Operating Results [Abstract]
Total revenues		35,157,248
Net loss		$ (13,654,001)
Net loss per common share (basic and diluted) (in dollars per share)		$ (0.80)
Orangelife [Member]
Business Combination, Consideration Transferred [Abstract]
Cash payment	$ 150,000
Shares issued (in shares)	153,707
Additional stock payment for acquisition based on approval of product registrations (in shares)	316,456
Fair value amount	$ 1,200,000
Fair values of Assets Acquired and Liabilities Assumed [Abstract]
Net current assets	320,293
Property, plant and equipment and other assets	226,035
Inventory	289,205
Goodwill	986,058
Deferred tax liability	(50,000)
Other intangible assets (estimated useful life) [Abstract]
Other intangible assets	200,000
Total consideration	1,971,591
Orangelife [Member] \| Trade Name [Member]
Other intangible assets (estimated useful life) [Abstract]
Other intangible assets	$ 5,000
Weighted average useful life	6 months
Orangelife [Member] \| Customer Contracts / Relationships [Member]
Other intangible assets (estimated useful life) [Abstract]
Other intangible assets	$ 195,000
Weighted average useful life	5 years

INVENTORIES (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
INVENTORIES [Abstract]
Raw Materials	$ 5,955,215	$ 2,901,319
Work in Process	2,549,516	793,343
Finished Goods	4,011,671	5,903,368
Inventories	$ 12,516,402	$ 9,598,030

FIXED ASSETS (Details) - USD ($)	12 Months Ended
FIXED ASSETS (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
Summary of fixed assets [Abstract]
Fixed assets, gross	$ 17,368,467	$ 13,262,741
Less: Accumulated Depreciation and Amortization	(8,680,064)	(7,329,172)
Fixed assets, net	8,688,403	5,933,569
Depreciation expense	1,227,860	933,558
Machinery and Equipment [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	10,996,869	7,955,511
Furniture and Fixtures [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	25,418	21,477
Computer Equipment [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	446,300	416,359
Leasehold Improvements [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	3,158,074	3,038,469
Enterprise Business Systems [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	2,741,806	1,830,925
Manufacturing Equipment [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	$ 3,011,273	$ 1,400,181

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract]
Accounts Payable - suppliers	$ 5,727,781	$ 3,144,098
Accrued Commissions & Royalties	807,708	931,760
Accrued Payroll	277,908	231,753
Accrued Vacation	417,238	410,199
Accrued Bonuses	1,193,985	215,000
Accrued Professional Fees	511,681	0
Accrued Expenses - Other	1,106,489	593,433
Total	$ 10,042,790	$ 5,526,243

REVENUE (Details) - USD ($)	12 Months Ended
REVENUE (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
REVENUE [Abstract]
Deferred revenue	$ 1,606,997	$ 125,000
Disaggregation of Revenue [Abstract]
Total revenues	32,470,197	34,464,032
Africa [Member]
Disaggregation of Revenue [Abstract]
Total revenues	4,890,370	7,564,360
Asia [Member]
Disaggregation of Revenue [Abstract]
Total revenues	824,488	888,800
Europe & Middle East [Member]
Disaggregation of Revenue [Abstract]
Total revenues	9,905,437	6,498,995
Latin America [Member]
Disaggregation of Revenue [Abstract]
Total revenues	9,841,773	11,808,768
United States [Member]
Disaggregation of Revenue [Abstract]
Total revenues	7,008,129	7,703,109
Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues	30,451,273	33,104,781
Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues	2,018,924	1,359,251
Net Product Revenue [Member]
Disaggregation of Revenue [Abstract]
Total revenues	24,767,149	28,844,997
Net Product Revenue [Member] \| Africa [Member]
Disaggregation of Revenue [Abstract]
Total revenues	4,890,370	7,564,360
Net Product Revenue [Member] \| Asia [Member]
Disaggregation of Revenue [Abstract]
Total revenues	824,488	888,800
Net Product Revenue [Member] \| Europe & Middle East [Member]
Disaggregation of Revenue [Abstract]
Total revenues	5,274,927	3,781,761
Net Product Revenue [Member] \| Latin America [Member]
Disaggregation of Revenue [Abstract]
Total revenues	9,841,772	11,808,767
Net Product Revenue [Member] \| United States [Member]
Disaggregation of Revenue [Abstract]
Total revenues	3,935,592	4,801,309
Net Product Revenue [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues	24,767,149	28,844,997
Net Product Revenue [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues	0	0
R&D Revenue [Member]
Disaggregation of Revenue [Abstract]
Total revenues	4,851,562	4,025,538
R&D Revenue [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues	4,851,562	3,321,031
R&D Revenue [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues	0	704,507
Government Grant Income [Member]
Disaggregation of Revenue [Abstract]
Total revenues	2,018,924	654,744
Government Grant Income [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues	0	0
Government Grant Income [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues	2,018,924	654,744
License and Royalty Revenue [Member]
Disaggregation of Revenue [Abstract]
Total revenues	832,562	938,753
License and Royalty Revenue [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues	832,562	938,753
License and Royalty Revenue [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues	$ 0	$ 0

INCOME TAXES (Details) - USD ($)	12 Months Ended			24 Months Ended
INCOME TAXES (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2003	Dec. 31, 2005
Current [Abstract]
Federal	$ (66,906)	$ 0
State	6,497	9,790
Foreign	0	3,633
Total current (benefit) provision	(60,409)	13,423
Deferred [Abstract]
Federal	0	0
State	0	0
Foreign	(396,385)	(513,715)
Total deferred (benefit) provision	(396,385)	(513,715)
Total (benefit) provision	$ (456,794)	$ (500,292)
Taxes [Abstract]
Federal income tax at statutory rates	21.00%	21.00%
State income taxes, net of federal benefit	(0.02%)	(0.05%)
Nondeductible expenses	(0.19%)	(1.00%)
Foreign rate differential	0.47%	0.45%
Change in valuation allowance	(19.37%)	(17.51%)
Other	(0.13%)	0.64%
Income tax benefit	1.76%	3.53%
Income Taxes [Abstract]
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	$ 27,001,828
Operating loss carryforwards, not subject to expiration	35,840,768
Components of Deferred Tax Assets and Liabilities [Abstract] [Abstract]
Inventory reserves	461,709	$ 196,193
Accrued expenses	130,291	105,323
Net operating loss carry-forwards	14,844,798	10,079,317
Research and development credit	1,696,870	1,679,495
Stock-based compensation	398,900	581,053
Interest Expense	602,187	0
Lease obligations	1,583,814	1,646,584
Depreciation	0	44,993
Total deferred tax assets	19,718,569	14,332,958
Right-of-use assets	(1,340,914)	(1,538,129)
Depreciation	(254,366)	0
Intangible	(821,363)	(921,807)
Total deferred tax liabilities	(2,416,643)	(2,459,936)
Net deferred tax assets before valuation allowance	17,301,926	11,873,022
Less valuation allowances	(17,371,867)	(12,339,348)
Net noncurrent deferred tax liabilities	(69,941)	(466,326)
Components of (loss) before income taxes [Abstract]
United States operations	(23,384,133)	(12,504,780)
International operations	(2,593,989)	(1,670,641)
(Loss) before taxes	(25,978,122)	$ (14,175,421)
Unremitted earnings of foreign subsidiaries	$ 0
Income Tax Contingencies [Abstract]
Open tax year	2017 2018 2019 2020
State [Member]
Tax Credit Carryforward [Abstract]
Operating loss carryforwards, subject to expiration	$ 3,511,090
Foreign [Member]
Tax Credit Carryforward [Abstract]
Operating loss carryforwards, not subject to expiration	$ 5,598,852

STOCKHOLDERS' EQUITY (Details) - USD ($)	1 Months Ended	12 Months Ended
STOCKHOLDERS' EQUITY (Details) - USD ($)	Apr. 30, 2020	Dec. 31, 2020	Dec. 31, 2019
Common Stock [Abstract]
Number of stock options exercised under the plan (in shares)		36,000	54,343
Exercised (in shares)		5,528	31,543
Exercise price of stock option (in dollars per share)		$ 6.30
Exercise price range of stock option (in dollars per share)		7.42
Underwritten public offering (in shares)	619,593
Underwritten exercise of overallotment (in shares)	281,125
Public offering price per share (in dollars per share)	$ 11.75	$ 5.40
Net proceeds after underwriting discounts and other offering expenses	$ 28,400,000	$ 28,436,740	$ 0
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
Minimum [Member]
Common Stock [Abstract]
Exercise price range of stock option (in dollars per share)			$ 3.48
Maximum [Member]
Common Stock [Abstract]
Exercise price range of stock option (in dollars per share)			$ 4.35

EQUITY INCENTIVE PLANS, Part 1 (Details) - USD ($)			12 Months Ended
EQUITY INCENTIVE PLANS, Part 1 (Details) - USD ($)	Jan. 03, 2020	Sep. 22, 2011	Dec. 31, 2020	Dec. 31, 2019	Jun. 19, 2014	Jun. 03, 2008
Stock options, number of shares [Roll forward]
Exercised (in shares)			5,528	31,543
Stock options, weighted average exercise price per share [Roll Forward]
Exercised (in dollars per share)			$ 6.30
Stock options, additional disclosure [Abstract]
Outstanding, aggregate intrinsic value, end of period			$ 1,520,910
Exercisable, aggregate intrinsic value, end of period			$ 0
Total fair value of stock options vested during period	$ 943,126
Stock Options [Member]
Assumptions made in calculating fair values of options [Abstract]
Expected term			6 years 3 months 14 days
Expected volatility			46.21%
Expected dividend yield			0.00%
Risk-free interest rate			1.30%
Stock options, number of shares [Roll forward]
Outstanding, beginning of period (in shares)			642,625
Granted (in shares)			726,280
Exercised (in shares)			36,000
Forfeited/expired/cancelled (in shares)			358,127
Outstanding, end of period (in shares)			974,778	642,625
Exercisable, end of period (in shares)			257,211
Stock options, weighted average exercise price per share [Roll Forward]
Outstanding, beginning of period (in dollars per share)			$ 5.79
Granted (in dollars per share)			2.59
Exercised (in dollars per share)			6.30
Forfeited/expired/cancelled (in dollars per share)			2.44
Outstanding, end of period (in dollars per share)			4.12	$ 5.79
Exercisable, end of period (in dollars per share)			$ 7.42
Stock options, additional disclosure [Abstract]
Outstanding, weighted average remaining contract term			5 years 2 months 8 days	2 years 6 months 25 days
Exercisable, weighted average remaining contract term			2 years 10 months 13 days
Outstanding, aggregate intrinsic value, beginning of period			$ 285,925
Granted, aggregate intrinsic value			0
Exercised, aggregate intrinsic value			95,976
Forfeited/expired/cancelled, aggregate intrinsic value			0
Outstanding, aggregate intrinsic value, end of period			1,520,910	$ 285,925
Exercisable, aggregate intrinsic value, end of period			0
Net unrecognized compensation cost			$ 736,339
Weighted average period for recognition of net unrecognized compensation cost			2 years 1 month 9 days
Total fair value of stock options vested during period			$ 326,630
2008 Stock Incentive Plan [Member]
Share-based Arrangements with Employees and Nonemployees [Abstract]
Number of stock options expired, forfeited or exercised under the plan (in shares)			694,000
Options still available to be issued (in shares)			0
Stock options, number of shares [Roll forward]
Outstanding, end of period (in shares)			56,000
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
2014 Stock Incentive Plan [Member]
Share-based Arrangements with Employees and Nonemployees [Abstract]
Options still available to be issued (in shares)			0
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 expired, forfeited or exercised under the plan (in shares)			514,782
Stock options, number of shares [Roll forward]
Outstanding, end of period (in shares)			264,157
2019 Omnibus Incentive Plan [Member]
Share-based Arrangements with Employees and Nonemployees [Abstract]
Number of stock options expired, forfeited or exercised under the plan (in shares)			489,294
Options still available to be issued (in shares)			1,506,226
Stock options, number of shares [Roll forward]
Outstanding, end of period (in shares)			1,024,563
2019 Omnibus Incentive Plan [Member] \| Stock Options [Member]
Share-based Arrangements with Employees and Nonemployees [Abstract]
Number of shares authorized under the plan (in shares)			2,400,000
Number of stock options forfeited under the plan (in shares)			123,127	0
2019 Omnibus Incentive Plan [Member] \| Restricted Stock [Member]
Share-based Arrangements with Employees and Nonemployees [Abstract]
Number of shares forfeited under the plan (in shares)			486,488	0

EQUITY INCENTIVE PLANS, Part 2 (Details) - USD ($)	12 Months Ended
EQUITY INCENTIVE PLANS, Part 2 (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense	$ 1,098,698	$ 1,655,900
Stock Options [Member]
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense	480,779	351,556
Cost of Product Sales [Member]
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense	6,300	10,806
Research and Development Expenses [Member]
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense	386,016	228,597
Selling, General and Administrative Expenses [Member]
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense	$ 706,382	$ 1,416,497

EQUITY INCENTIVE PLANS, Part 3 (Details)	12 Months Ended
EQUITY INCENTIVE PLANS, Part 3 (Details)	Dec. 31, 2020 USD ($) $ / shares shares
Stock Options Outstanding [Abstract]
Shares outstanding (in shares) \| shares	974,778
Average remaining contract life	5 years 2 months 8 days
Weighted average exercise price (in dollars per share)	$ 4.12
Aggregate intrinsic value \| $	$ 1,520,910
Stock Options Exercisable [Abstract]
Shares exercisable (in shares) \| shares	257,211
Weighted average exercise price (in dollars per share)	$ 7.42
Aggregate intrinsic value \| $	$ 0
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) \| shares	636,364
Average remaining contract life	6 years 2 months 15 days
Weighted average exercise price (in dollars per share)	$ 2.36
Aggregate intrinsic value \| $	$ 1,520,910
Stock Options Exercisable [Abstract]
Shares exercisable (in shares) \| 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) \| 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) \| shares	0
Weighted average exercise price (in dollars per share)	$ 0
Aggregate intrinsic value \| $	$ 0
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) \| shares	83,664
Average remaining contract life	4 years 3 months
Weighted average exercise price (in dollars per share)	$ 5.53
Aggregate intrinsic value \| $	$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares) \| shares	39,961
Weighted average exercise price (in dollars per share)	$ 5.53
Aggregate intrinsic value \| $	$ 0
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) \| shares	207,875
Average remaining contract life	3 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) \| shares	189,125
Weighted average exercise price (in dollars per share)	$ 7.22
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) \| shares	46,875
Average remaining contract life	2 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) \| shares	28,125
Weighted average exercise price (in dollars per share)	$ 11.45
Aggregate intrinsic value \| $	$ 0

EQUITY INCENTIVE PLANS, Part 4 (Details) - USD ($)	12 Months Ended
EQUITY INCENTIVE PLANS, Part 4 (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
Weighted Average Grant Date Fair Value [Abstract]
Allocated share-based compensation expense	$ 1,098,698	$ 1,655,900
Restricted Stock and Restricted Stock Units [Member]
Number of Shares & Units [Abstract]
Outstanding, beginning of period (in shares)	545,986
Granted (in shares)	656,759
Vested (in shares)	112,726
Forfeited/expired/cancelled (in shares)	486,488
Outstanding, end of period (in shares)	603,531	545,986
Weighted Average Grant Date Fair Value [Abstract]
Outstanding, beginning of period (in dollars per share)	$ 7.47
Granted (in dollars per share)	2.75
Vested (in dollars per share)	5.63
Forfeited/expired/cancelled (in dollars per share)	6.43
Outstanding, end of period (in dollars per share)	$ 3.08	$ 7.47
Net unrecognized compensation cost	$ 1,215,441
Weighted average period for recognition of net unrecognized compensation cost	1 year 9 months 18 days
Allocated share-based compensation expense	$ 617,919	$ 1,394,814

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY (Details) - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	$ 32,470,197	$ 34,464,032
Geographic Areas, Long-Lived Assets [Abstract]
Long-lived assets	8,688,403	5,933,569
Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	24,767,149	28,844,997
Africa [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	4,890,370	7,564,360
Africa [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	4,890,370	7,564,360
Asia [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	824,488	888,800
Geographic Areas, Long-Lived Assets [Abstract]
Long-lived assets	326,267	393,299
Asia [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	824,488	888,800
Europe & Middle East [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	9,905,437	6,498,995
Geographic Areas, Long-Lived Assets [Abstract]
Long-lived assets	147,692	165,029
Europe & Middle East [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	5,274,927	3,781,761
Latin America [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	9,841,773	11,808,768
Geographic Areas, Long-Lived Assets [Abstract]
Long-lived assets	14,719	60,527
Latin America [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	9,841,772	11,808,767
United States [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	7,008,129	7,703,109
Geographic Areas, Long-Lived Assets [Abstract]
Long-lived assets	8,199,725	5,314,715
United States [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	$ 3,935,592	$ 4,801,309

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS (Details)

12 Months Ended

Jan. 03, 2020

USD ($)

Dec. 31, 2020

USD ($)

KeyEmployee

Lawsuit

Applicants

Dec. 31, 2019

USD ($)

Employment Contracts [Abstract]

Number of key employees with whom Company has employment contracts | KeyEmployee

Aggregate annual salaries of employment contracts

$ 843,292

Contract one, expiration date

Dec. 31, 2021

Contract two, expiration date

Dec. 31, 2022

Future minimum salary commitments [Abstract]

2021

$ 843,292

2022

460,000

2023

$ 0

Benefit Plan [Abstract]

Percentage of employer's matching contribution

40.00%

$ 87,377

$ 93,892

Components of Lease Expense [Abstract]

Operating lease expense

1,669,105

1,655,573

Finance lease cost [Abstract]

Amortization of right-of-use assets

58,414

23,372

Interest on lease liabilities

19,986

7,892

Total finance lease expense

78,400

31,264

Cash paid for amounts included in the measurement of lease liabilities [Abstract]

Operating cash flows for operating leases

1,139,944

632,952

Operating cash flows for finance leases

19,987

7,892

Financing cash flows for finance leases

51,166

19,875

Right-of-use assets obtained in exchange for lease obligations [Abstract]

Right-of-use assets obtained in exchange for lease obligations

7,892

Operating leases

7,030,744

Finance leases

69,528

210,350

Finance Leases [Abstract]

Finance lease right of use asset

315,154

233,722

Accumulated depreciation

(82,020)

(23,372)

Finance lease right of use asset, net

233,134

210,350

Finance Lease Liability [Abstract]

Current portion of finance lease liability

58,877

41,894

Finance lease liability

185,239

171,953

Total finance lease liabilities

$ 244,116

$ 213,847

Weighted Average Remaining Lease Term [Abstract]

Operating leases

9 years

9 years 3 months 18 days

Finance leases

3 years 8 months 12 days

4 years 9 months 18 days

Weighted Average Discount Rate [Abstract]

Operating leases

8.58%

8.67%

Finance leases

8.18%

7.00%

Maturities of Operating Lease Liabilities [Abstract]

2021

$ 1,209,787

$ 1,205,161

2022

1,057,757

1,209,787

2023

1,026,272

1,057,757

2024

1,018,875

1,026,272

2025

1,049,442

1,018,875

Thereafter

4,724,445

5,773,887

Total lease payments

10,086,578

11,291,739

Less: imputed interest

(3,116,975)

(3,753,842)

Total

6,969,603

7,537,897

Maturities of Finance Lease Liabilities [Abstract]

2021

76,904

55,536

2022

76,904

55,536

2023

76,904

55,536

2024

49,136

55,536

2025

5,755

27,767

Thereafter

Total lease payments

285,603

249,911

Less: imputed interest

(41,487)

(36,064)

Total

244,116

213,847

Concentrations [Abstract]

Net sales

32,470,197

34,464,032

Accounts Receivable

$ 3,377,387

3,661,325

Employee Litigation [Abstract]

Exercise price of stock options

$ 943,126

Vested shares exercisable (in shares) | shares

266,666

Term to exercise stock options

30 days

Number of class action lawsuits | Lawsuit

Number of motions for appointment as lead plaintiff | Applicants

Number of motions abandoned | Applicants

Number of remaining motions for appointment as lead plaintiff | Applicants

Number of motions filed by special situations funds | Applicants

Number of motions filed by municipal employees retirement system | Applicants

Vendor 1 [Member]

Concentrations [Abstract]

Purchases

$ 2,222,182

^[1]

Accounts Payable

222,588

^[1]

Customer Concentration Risk [Member] | Customer 1 [Member]

Concentrations [Abstract]

Accounts Receivable

522,218

941,962

Customer Concentration Risk [Member] | Customer 2 [Member]

Concentrations [Abstract]

Accounts Receivable

1,987

16,033

Customer Concentration Risk [Member] | Customer 3 [Member]

Concentrations [Abstract]

Accounts Receivable

^[1]

Maximum [Member]

Benefit Plan [Abstract]

Employee contribution subject to employer matching contribution

5.00%

Employer matching contribution

2.00%

Sales [Member] | Customer Concentration Risk [Member] | Customer 1 [Member]

Concentrations [Abstract]

Net sales

$ 6,224,737

$ 11,263,573

Concentration risk percentage

25.10%

39.00%

Sales [Member] | Customer Concentration Risk [Member] | Customer 2 [Member]

Concentrations [Abstract]

Net sales

$ 2,955,312

$ 5,782,543

Concentration risk percentage

11.90%

20.00%

Sales [Member] | Customer Concentration Risk [Member] | Customer 3 [Member]

Concentrations [Abstract]

Net sales

$ 2,956,945

^[1]

Concentration risk percentage

11.90%

^[1]

Purchases [Member] | Vendor 1 [Member]

Concentrations [Abstract]

Concentration risk percentage

13.00%

^[1]

[1]	In the tables above, an asterisk (*) indicates that indicates that sales, accounts receivable, purchases or accounts payable, as applicable to the tabular column, did not exceed 10% for the period indicated.

LONG-TERM DEBT (Details) - Note Payable - Equipment Vendor [Member] - USD ($)	1 Months Ended	12 Months Ended
	Sep. 30, 2017	Dec. 31, 2020
Debt Instruments [Abstract]
Debt instrument, face amount	$ 660,000
Percentage of first payment of the term	30.00%
Percentage of second payment of the term	60.00%
Percentage of prepayment after delivery	10.00%
Percentage of first payment of the term by the vendor	15.00%
Percentage of second payment of the term by the vendor	40.00%
Percentage of payment 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

LONG-TERM DEBT, Credit Agreement (Details) - Senior Secured Term Loan Credit Facility [Member] - USD ($)		12 Months Ended
	Sep. 03, 2019	Dec. 31, 2020
Credit Agreement [Abstract]
Debt instrument, face amount	$ 20,000,000
Lender's closing cost	550,000
Financing fee	$ 600,000
Percentage of gross proceeds considered as financing fee	3.00%
Interest rate	8.75%	11.25%
Increase in interest rate in event of default	4.00%
Principal installment payable	$ 300,000
Debt instrument maturity date		Sep. 03, 2023
Outstanding loan balance, net		$ 18,200,000
September 4, 2019 to September 3 ,2020 [Member]
Credit Agreement [Abstract]
Percentage of prepaid principal as premium	10.00%
September 4, 2020 to September 3 ,2021 [Member]
Credit Agreement [Abstract]
Percentage of prepaid principal as premium	8.00%
September 4, 2021 to September 3 ,2022 [Member]
Credit Agreement [Abstract]
Percentage of prepaid principal as premium	4.00%
LIBOR [Member]
Credit Agreement [Abstract]
Term of variable rate		1 month
Basis spread on variable rate	2.50%

WARRANTS (Details) $ / shares in Units, $ in Millions	12 Months Ended
WARRANTS (Details) $ / shares in Units, $ in Millions	Dec. 31, 2020 USD ($) $ / shares	Apr. 30, 2020 $ / shares	Sep. 03, 2019 shares
WARRANTS [Abstract]
Warrant term	7 years
Warrants to purchase of common stock (in shares) \| shares			550,000
Estimated Fair Value of Warrant Assumptions [Abstract]
Stock price on issuance date (in dollars per share)	$ 5.40	$ 11.75
Strike Price (in dollars per share)	$ 5.22
Expected life	7 years
Fair value of warrants \| $	$ 1.4
Fair value of warrants (in dollars per share)	$ 2.49
Risk-Free Interest Rate [Member]
Estimated Fair Value of Warrant Assumptions [Abstract]
Measurement input	0.0145
Volatility [Member]
Estimated Fair Value of Warrant Assumptions [Abstract]
Measurement input	0.4365

GOODWILL AND INTANGIBLE ASSETS (Details) - USD ($)	12 Months Ended
GOODWILL AND INTANGIBLE ASSETS (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
Impairment of Intangible Assets [Abstract]
Impairment of intangible assets	$ 0	$ 0
Goodwill [Roll Forward]
Goodwill, Beginning balance	5,872,690
Changes in foreign currency exchange rate	91,054
Goodwill, Ending balance	5,963,744	5,872,690
Intangible assets [Abstract]
Cost	5,179,967	4,781,830
Accumulated Amortization	1,533,981	867,478
Net Book Value	3,645,986	3,914,352
Amortization Expense [Abstract]
Amortization expense	588,962	515,263
Amortization expense 2021	617,000
Amortization expense 2022	617,000
Amortization expense 2023	617,000
Amortization expense 2024	617,000
Amortization expense 2025	617,000
Amortization expense, thereafter	$ 561,000
Intellectual Property [Member]
Intangible assets [Abstract]
Weighted average remaining life of intangible assets	5 years
Cost	$ 1,638,699	1,418,681
Accumulated Amortization	472,190	299,232
Net Book Value	$ 1,166,509	1,119,449
Developed Technology [Member]
Intangible assets [Abstract]
Weighted average remaining life of intangible assets	5 years
Cost	$ 2,102,526	1,922,682
Accumulated Amortization	594,186	266,550
Net Book Value	$ 1,508,340	1,656,132
Customer Contracts / Relationships [Member]
Intangible assets [Abstract]
Weighted average remaining life of intangible assets	6 years
Cost	$ 1,323,424	1,325,521
Accumulated Amortization	423,093	270,902
Net Book Value	$ 900,331	1,054,619
Trade Name [Member]
Intangible assets [Abstract]
Weighted average remaining life of intangible assets	7 years
Cost	$ 115,318	114,946
Accumulated Amortization	44,512	30,794
Net Book Value	$ 70,806	$ 84,152

SUBSEQUENT EVENTS (Details) - Forecast [Member] $ in Millions	6 Months Ended
	Jun. 30, 2021 USD ($)
Minimum [Member]
Restructuring Costs [Abstract]
Pre-tax charges	$ 0.1
Maximum [Member]
Restructuring Costs [Abstract]
Pre-tax charges	$ 0.2