0001140361-22-017906 | 10-Q | XBRL Viewer

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2022	Apr. 29, 2022
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2022
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q1
Document Transition Report	false
Entity File Number	000-30379
Entity Registrant Name	Chembio Diagnostics, Inc.
Entity Central Index Key	0001092662
Entity Incorporation, State or Country Code	NV
Entity Tax Identification Number	88-0425691
Entity Address, Address Line One	555 Wireless Blvd.
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
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
Title of 12(b) Security	Common Stock, $0.01 par value
Trading Symbol	CEMI
Security Exchange Name	NASDAQ
Entity Common Stock, Shares Outstanding		30,221,859

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)	Mar. 31, 2022	Dec. 31, 2021
CURRENT ASSETS:
Cash and cash equivalents	$ 24,399,388	$ 28,772,892
Accounts receivable, net of allowance for doubtful accounts of $242,981 and $243,042 at March 31, 2022 and December 31, 2021, respectively	9,879,954	11,441,107
Inventories, net	11,844,121	12,920,451
Prepaid expenses and other current assets	2,097,491	2,096,399
TOTAL CURRENT ASSETS	48,220,954	55,230,849
FIXED ASSETS:
Property, plant and equipment, net	8,414,313	8,556,773
Finance lease right-of-use assets, net	190,526	191,870
OTHER ASSETS:
Operating lease right-of-use assets, net	5,693,482	5,891,906
Goodwill	0	3,022,787
Deposits and other assets	370,940	358,010
TOTAL ASSETS	62,890,215	73,252,195
CURRENT LIABILITIES:
Accounts payable and accrued liabilities	10,542,851	13,127,993
Current portion of long-term debt	2,100,000	1,200,000
Operating lease liabilities	916,524	886,294
Finance lease liabilities	72,203	68,176
TOTAL CURRENT LIABILITIES	13,631,578	15,282,463
OTHER LIABILITIES:
Long-term operating lease liabilities	5,733,214	5,976,151
Long-term finance lease liabilities	134,955	139,678
Long-term debt, net	16,855,322	17,589,003
TOTAL LIABILITIES	36,355,069	38,987,295
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY:
Preferred stock - 10,000,000 shares authorized, none outstanding	0	0
Common stock - $0.01 par value; 100,000,000 shares authorized; 30,269,916 shares and 30,104,986 shares issued at March 31, 2022 and December 31, 2021, respectively	302,699	301,050
Additional paid-in capital	166,483,376	165,772,636
Accumulated deficit	(139,800,154)	(131,009,860)
Treasury Stock, 48,057 shares at cost, at March 31, 2022 and December 31, 2021	(206,554)	(206,554)
Accumulated other comprehensive (loss)	(244,221)	(592,372)
TOTAL STOCKHOLDERS' EQUITY	26,535,146	34,264,900
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 62,890,215	$ 73,252,195

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
CURRENT ASSETS:
Accounts receivable, allowance for doubtful accounts	$ 242,981	$ 243,042
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)	30,269,916	30,104,986
Treasury stock, shares (in shares)	48,057	48,057

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
REVENUES:
REVENUES	$ 18,816,611	$ 8,724,359
COSTS AND EXPENSES:
Cost of product revenue	15,223,861	3,548,441
Research and development expenses	1,653,706	2,863,338
Selling, general and administrative expenses	6,946,271	6,085,067
Impairment, restructuring, severance and related costs	3,043,179	83,087
TOTAL COSTS AND EXPENSES	26,867,017	12,579,933
LOSS FROM OPERATIONS	(8,050,406)	(3,855,574)
OTHER EXPENSE:
Interest expense, net	(733,561)	(712,477)
LOSS BEFORE INCOME TAXES	(8,783,967)	(4,568,051)
Income tax (expense)/benefit	(6,327)	67,888
NET LOSS	$ (8,790,294)	$ (4,500,163)
Basic loss per share (in dollars per share)	$ (0.29)	$ (0.22)
Diluted loss per share (in dollars per share)	$ (0.29)	$ (0.22)
Weighted average number of shares outstanding, basic (in shares)	30,090,045	20,163,386
Weighted average number of shares outstanding, diluted (in shares)	30,090,045	20,163,386
Product Revenue [Member]
REVENUES:
REVENUES	$ 18,527,456	$ 4,024,662
R&D Revenue [Member]
REVENUES:
REVENUES	18,173	1,106,639
Government Grant Income [Member]
REVENUES:
REVENUES	0	3,350,000
License and Royalty Revenue [Member]
REVENUES:
REVENUES	$ 270,982	$ 243,058

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS [Abstract]
Net loss	$ (8,790,294)	$ (4,500,163)
Other comprehensive income (loss):
Foreign currency translation adjustments, net of tax	348,151	(455,722)
COMPREHENSIVE LOSS	$ (8,442,143)	$ (4,955,885)

- 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

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($)	Common Stock [Member]	Additional Paid-in-Capital [Member]	Treasury Stock [Member]	Accumulated Deficit [Member]	AOCL [Member]	Total
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)
Common Stock:
Restricted stock issued	$ 622	58,909	$ 0	0	0	59,531
Restricted stock issued (in shares)	62,197		0
Restricted stock compensation, net	$ 0	309,010	$ 0	0	0	309,010
Restricted stock compensation, net (in shares)	0		0
Shares tendered for withholding taxes	$ 0	(115,059)	$ 0	0	0	(115,059)
Shares tendered for withholding taxes (in shares)	0		0
Options:
Stock option compensation	$ 0	211,140	$ 0	0	0	211,140
Comprehensive income (loss)	0	0	0	0	(455,722)	(455,722)
Net loss	0	0	0	(4,500,163)	0	(4,500,163)
Balance at Mar. 31, 2021	$ 202,857	125,425,514	$ (190,093)	(101,606,494)	(546,638)	23,285,146
Balance (in shares) at Mar. 31, 2021	20,285,695		(41,141)
Balance at Dec. 31, 2021	$ 301,050	165,772,636	$ (206,554)	(131,009,860)	(592,372)	34,264,900
Balance (in shares) at Dec. 31, 2021	30,104,986		(48,057)
Common Stock:
Restricted stock issued	$ 1,649	264,437	$ 0	0	0	266,086
Restricted stock issued (in shares)	164,930		0
Restricted stock compensation, net	$ 0	229,563	$ 0	0	0	229,563
Restricted stock compensation, net (in shares)	0		0
Shares tendered for withholding taxes	$ 0	(38,514)	$ 0	0	0	(38,514)
Shares tendered for withholding taxes (in shares)	0		0
Options:
Stock option compensation	$ 0	255,254	$ 0	0	0	255,254
Comprehensive income (loss)	0	0	0	0	348,151	348,151
Net loss	0	0	0	(8,790,294)	0	(8,790,294)
Balance at Mar. 31, 2022	$ 302,699	$ 166,483,376	$ (206,554)	$ (139,800,154)	$ (244,221)	$ 26,535,146
Balance (in shares) at Mar. 31, 2022	30,269,916		(48,057)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Cash received from customers and grants	$ 20,377,703	$ 8,485,683
Cash paid to suppliers and employees	(23,810,426)	(14,830,243)
Cash paid for operating leases	(360,878)	(347,871)
Cash paid for finance leases	(4,686)	(4,944)
Interest and taxes, net	(570,672)	(563,885)
Net cash used in operating activities	(4,368,959)	(7,261,260)
CASH FLOWS FROM INVESTING ACTIVITIES:
Patent application costs	0	(4,130)
Acquisition of and deposits on fixed assets	(286,544)	(1,235,038)
Net cash used in investing activities	(286,544)	(1,239,168)
CASH FLOWS FROM FINANCING ACTIVITIES:
Payments of tax withholdings on stock award	(38,514)	(115,059)
Payments on finance lease	(16,930)	(14,282)
Net cash used in financing activities	(55,444)	(129,341)
Effect of exchange rate changes on cash	337,443	(85,579)
DECREASE IN CASH AND CASH EQUIVALENTS	(4,373,504)	(8,715,348)
Cash and cash equivalents - beginning of the period	28,772,892	23,066,301
Cash and cash equivalents - end of the period	24,399,388	14,350,953
RECONCILIATION OF NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES:
Net loss	(8,790,294)	(4,500,163)
Adjustments:
Depreciation and amortization	598,548	687,227
Share based compensation	750,903	579,789
Benefit from deferred tax liability	0	(69,941)
Provision of (recovery of) doubtful accounts	(61)	57,735
Impairment	3,033,565	0
Changes in assets and liabilities:
Accounts receivable	1,561,214	906,100
Inventories	1,076,330	(2,174,225)
Prepaid expenses and other current assets	(387,297)	(33,955)
Deposits and other assets	373,275	134,480
Accounts payable and accrued liabilities	(2,585,142)	(1,645,796)
Deferred revenue	0	(1,202,511)
Net cash used in operating activities	$ (4,368,959)	$ (7,261,260)

DESCRIPTION OF BUSINESS

3 Months Ended

Mar. 31, 2022

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 diagnostic tests used for the rapid detection and diagnosis of infectious diseases, including sexually transmitted disease, insect vector and tropical disease, COVID-19 and other viral and bacterial infections, enabling expedited treatment.

The Company’s product portfolio is based upon our proprietary DPP technology, a diagnostic platform that provides high-quality, cost-effective results in 15 to 20 minutes using fingertip blood, nasal swabs and other sample types. The DPP technology platform addresses the rapid diagnostic test market, which includes infectious diseases such as STIs and HIV, Gastroenterology and Women’s Health. Compared with traditional lateral flow technology, the DPP technology platform can provide:

•

Enhanced sensitivity and specificity: This is achieved via the Company’s proprietary approach to separating the sample path from the buffer path, together with patent and other proprietary strategies, which differ significantly from traditional lateral flow test.

•

Advanced multiplexing capabilities: Through advanced multiplexing, the DPP platform can detect and differentiate up to eight distinct test results from a single patient sample, which can deliver greater clinical value than other rapid tests currently on the market.

•

Objective results: For some diagnostic applications, the Company’s easy-to-use, highly portable, battery-operated DPP Micro Reader optical analyzers can report 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.

The Company targets the market for rapid diagnostic test solutions for infectious diseases, which is driven by the high prevalence of infectious diseases globally, an increase in the geriatric population, growing demand for rapid test results, and advancements in multiplexing. The Company has a broad portfolio of infectious disease products, which prior to 2020 were focused principally on sexually transmitted disease and fever and tropical disease. In February 2020 the Company began the process of shifting substantially all of its resources to seek to leverage the DPP technology platform to address the acute and escalating need for diagnostic testing for COVID-19. The Company is continuing to pursue:

•

an emergency use authorization (“EUA”), from the U.S. Food and Drug Administration (the “FDA”), as well as 510(k) clearance from the FDA, for the DPP SARS-CoV-2 Antigen test system;

•

an EUA from the FDA for the DPP Respiratory Antigen Panel; and

•

a Clinical Laboratory Improvement Amendment (“CLIA”), waiver from the FDA for the DPP HIV-Syphilis test system.

SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Mar. 31, 2022

SIGNIFICANT ACCOUNTING POLICIES [Abstract]

SIGNIFICANT ACCOUNTING POLICIES

NOTE 2 — SIGNIFICANT ACCOUNTING POLICIES:

(a)

Basis of presentation:

The accompanying unaudited condensed consolidated financial statements include the accounts of Chembio and its subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X issued by the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. Certain reclassifications have been made to the unaudited condensed consolidated balance sheet of the prior year to conform to the current year presentation. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in Chembio’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as filed with the SEC.

Going Concern Considerations

The Company continued to experience market, clinical trial and regulatory complications in seeking to develop and commercialize a portfolio of COVID-19 test systems during the continuing, but evolving, uncertainty resulting from COVID‑19. For the three months ended March 31, 2022, the Company continued to incur significant expenses in connection with pending legal matters (see Note 6 – Commitments, Contingencies, and Concentrations: Litigation).

The Company performed an assessment to determine whether there were conditions or events that, considered in the aggregate, raised substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying unaudited condensed consolidated financial statements are being issued. Initially, this assessment did not consider the potential mitigating effect of management’s plans that had not been fully implemented. Because, as described below, substantial doubt was determined to exist as the result of this initial assessment, management then assessed the mitigating effect of its plans to determine if it is probable that the plans (1) would be effectively implemented within one year after the date the accompanying unaudited condensed consolidated financial statements are issued and (2) when implemented, would mitigate the relevant conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern.

The Company achieved significant revenue growth in recent years while profitability has not been at levels as expected. It has taken steps including investments in automation to mitigate headwinds such as labor availability, volatile capacity planning and implementation of operational efficiency targets to proactively monitor production with the overarching goal for profitable growth. During the three months ended March 31, 2022, the Company undertook measures to increase its total revenues and improve its liquidity position by implementing the Global Competitiveness Program. The main pillars of the Global Competitiveness Program include the following:

•	Focus on higher margin business in growth markets

•	Lower manufacturing costs

•	Reduce infrastructure costs

•	Strategic review of non-core businesses and assets:

In addition, the Company will continue to focus on regulatory approvals for its DPP SARS-CoV-2 Antigen test system, DPP Respiratory Antigen Panel, and DPP HIV-Syphilis test system. These measures and other plans and initiatives have been designed to provide the Company with adequate liquidity to meet its obligations for at least the twelve-month period following the date the accompanying unaudited condensed consolidated financial statements are being issued. The Company’s execution of those measures and its other plans and initiative continue to depend, however, on factors and uncertainties that are beyond the Company’s control, or that may not be addressable on terms acceptable to the Company or at all. The Company considered in particular how:

•

The ongoing healthcare and economic impacts of COVID-19 on the global customer base for the Company’s non‑COVID-19 products continue to negatively affect the timing and rate of recovery of the Company’s revenues from those products by, for example, decreasing the allocation of funding for HIV testing, thereby continuing to adversely affect the Company’s liquidity.

•	Although the Company has entered into agreements to distribute third-party COVID-19 products in the United States, its ability to sell those products could be constrained because of staffing and supply chain limitations affecting the suppliers of those products.

The Company further considered how these factors and uncertainties could impact its ability over the next year to meet the obligations specified in the Credit Agreement with the Lender (both as defined in Note 7 – Long-Term Debt). Those obligations include covenants requiring: i) minimum cash balance of $3.0 million and ii) minimum total revenue amounts for the twelve months preceding each quarter end. For the next year, the minimum total revenue requirements range from $43.8 million for the twelve months ending June 30, 2022 to $48.8 million for the twelve months ending March 31, 2023. Upon an event of default under the Credit Agreement, the Lender could elect to declare all amounts outstanding thereunder, together with accrued interest, to be immediately due and payable. In such an event, there can be no assurance that the Company would have sufficient liquidity to fund payment of the amounts that would be due under the Credit Agreement or that, if such liquidity were not available, the Company would be successful in raising additional capital on acceptable terms, or at all, or in completing any other endeavor to continue to be financially viable and continue as a going concern. The Company’s inability to raise additional capital on acceptable terms in the near future, whether for purposes of funding payments required under the Credit Agreement or providing additional liquidity needed for its operations, could have a material adverse effect on its business, prospects, results of operations, liquidity and financial condition.

Accordingly, management determined the Company could not be certain that the Company’s plans and initiatives would be effectively implemented within one year after the date on which the accompanying unaudited condensed consolidated financial statements are being issued. Without giving effect to the prospect of raising additional capital pursuant to the Company’s At the Market Offering Agreement dated July 19, 2021 with Chembio Diagnostics, Inc. and Craig-Hallum Capital Group LLC, increasing product revenue in the near future or executing other mitigating plans, many of which are beyond the Company’s control, it is unlikely that the Company will be able to generate sufficient cash flows to meet its required financial obligations, including its debt service and other obligations due to third parties. The existence of these conditions raises substantial doubt about the Company’s ability to continue as a going concern for the twelve-month period following the date on which the accompanying unaudited condensed consolidated financial statements are being issued.

The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities in the normal course of business for the twelve-month period following the date the accompanying unaudited condensed consolidated financial statements are issued. As such, the accompanying unaudited condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets and their carrying amounts, or the amount and classification of liabilities that may result should the Company be unable to continue as a going concern.

(b)

Significant Accounting Policies:

During the three months ended March 31, 2022, there has been no significant changes to the Company’s summary of significant accounting policies contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC.

(c)

Fair Value of Financial Instruments:

The carrying values for cash and cash equivalents, accounts receivable, accounts payable and 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 were $ 17.1 million and $25.0 million as of March 31, 2022 and December 31, 2021, 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 $20.0 million (carrying value of $18.9 million) and $20.0 million (carrying value of $18.8 million) as of March 31, 2022 and December 31, 2021 respectively, is a Level 2 fair value measurement under the hierarchy and the Company’s debt face value approximates the recorded value, as the rate is based upon the current rates available to the Company for similar financial instruments.

Fair value measurements of all financial assets and liabilities that are 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, such as money market funds, with original maturities of three months or less at date of purchase.

(e)

Loss Per Share:

Basic loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period excluding unvested restricted stock. Diluted loss per share for the three months ended March 31, 2022 and 2021 reflects the potential dilution from the exercise or conversion of other securities into common stock, if dilutive.

There were 3,760,787 and 1,848,286 options outstanding as of March 31, 2022 and 2021, respectively, that were not included in the calculation of diluted per common share equivalents for the three months ended March 31, 2022 and 2021, respectively, because the effect would have been anti-dilutive.

There were 1,739,944 and 847,795 shares of restricted stock outstanding as of March 31, 2022 and 2020, respectively, that were not included in the calculation of diluted per common share equivalents for the three months ended March 31, 2022 and 2021, respectively, because the effect would have been anti-dilutive.

(f)

Income Taxes:

At the end of each interim reporting period, the Company estimates its effective tax rate expected to be applied for the full year. This estimate is used to determine the income tax provision or benefit on a year-to-date basis, and may change in subsequent interim periods. Accordingly, the Company’s effective tax rate for the three months ended March 31, 2022 was (0.1)%, compared to the effective tax rate of 1.6% for the three months ended March 31, 2021. The Company’s effective tax rates for both periods were affected primarily by a full valuation allowance on domestic net deferred tax assets.

(g)

Recently Issued Accounting Standards Affecting the Company:

Recently Adopted

ASU 2021-10 - Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance

In November 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance, which creates Accounting Standards Codification (“ASC”) 832 and aims to provide increased transparency by requiring business entities to disclose information about certain types of government assistance they receive in the notes to the financial statements. The disclosure requirements in ASC 832 only apply to transactions with a government that are accounted for by analogizing to either a grant model (for example, in International Accounting Standard 20, Accounting for Government Grants and Disclosure of Government Assistance), or a contribution model (for example, in ASC 958-605, Not-for-Profit Entities – Revenue Recognition). The FASB broadly defined “government assistance” in ASC 832 to ensure that assistance received from most types of governmental entities or other related organizations would be disclosed. Entities are required to provide the new disclosures prospectively for all transactions with a government entity that are accounted for under either a grant or a contribution accounting model and are reflected in the financial statements at the date of initially applying the new amendments, and to new transactions entered into after that date. Retrospective application of the guidance is permitted. The Company adopted the standard effective January 1, 2022 and has determined that the adoption did not have a material impact on the Company’s consolidated financial statements.

Not Yet Adopted

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 GAAP. ASU 2020-06 simplifies the guidance in 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 the potential impact of the standard and will disclose the nature and reason for any elections that the Company makes.

ASU 2021-08—Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers

On October 28, 2021, the FASB issued ASU 2021-08,1 which amends ASC 805 to “require acquiring entities to apply Topic 606 to recognize and measure contract assets and contract liabilities in a business combination.” Under current GAAP, an acquirer generally recognizes such items at fair value on the acquisition date. ASU 2021-08 amends ASC 805 to add contract assets and contract liabilities to the list of exceptions to the recognition and measurement principles that apply to business combinations and to “require that an entity (acquirer) recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with Topic 606.” While primarily related to contract assets and contract liabilities that were accounted for by the acquiree in accordance with ASC 606, “the amendments also apply to contract assets and contract liabilities from other contracts to which the provisions of Topic 606 apply, such as contract liabilities from the sale of nonfinancial assets within the scope of Subtopic 610-20.” The ASU’s amendments are effective for public business entities for the fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The amendments should be applied prospectively to business combinations occurring on or after the effective date of the amendments. The Company continues to assess the potential impact of the standard and will disclose the nature and reason for any elections that the Company makes.

REVENUE

3 Months Ended

Mar. 31, 2022

REVENUE [Abstract]

REVENUE

NOTE 3 — REVENUE:

Disaggregation of Revenue

The following table disaggregates Total Revenues by revenue type:

	March 31, 2022						March 31, 2021
	Exchange Transactions		Non-Exchange Transactions		Total		Exchange Transactions		Non-Exchange Transactions		Total
Net product revenue	$	18,527,456	$	-	$	18,527,456	$	4,024,662	$	-	$	4,024,662
R&D Revenue		18,173		-		18,173		1,106,639		-		1,106,639
Government grant revenue		–		–		–		–		3,350,000		3,350,000
License and royalty revenue		270,982		-		270,982		243,058		-		243,058
	$	18,816,611	$	-	$	18,816,611	$	5,374,359	$	3,350,000	$	8,724,359

Exchange transactions are recognized in accordance with ASC 606, while non-exchange transactions are recognized in accordance with ASU No. 2018-08.

The following table disaggregates Total Revenues by geographic location:

	For the three months ended
	March 31, 2022		March 31, 2021
Africa	$	767,352	$	1,344,858
Asia		15,558		216,954
Europe & Middle East		723,745		2,600,274
Latin America		12,557,390		258,019
United States		4,752,566		4,304,254
	$	18,816,611	$	8,724,359

- 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.

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+ Details

INVENTORY

3 Months Ended

Mar. 31, 2022

INVENTORY [Abstract]

INVENTORY

NOTE 4 — INVENTORY:

Inventories are presented net of reserves and consist of the following at:

	March 31, 2022		December 31, 2021
Raw materials	$	7,197,257	$	7,306,095
Work in process		1,932,069		3,556,878
Finished goods		2,714,795		2,057,478
	$	11,844,121	$	12,920,451

STOCKHOLDERS' EQUITY

3 Months Ended

Mar. 31, 2022

STOCKHOLDERS' EQUITY [Abstract]

STOCKHOLDERS' EQUITY

NOTE 5 — STOCKHOLDERS’ EQUITY:

(a)

Common Stock

During the first three months of 2022 and 2021, there were no options exercised.

(b)

Preferred Stock

Chembio 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 of Chembio (the “Board”) and the filing of a Certificate of Designation with the state of Nevada.

(c)

Treasury Stock

Chembio has 48,057 shares of treasury stock acquired upon the vesting of restricted stock awards related to the tax withholding requirements paid on behalf of the employees.

(d)

Options, Restricted Stock, and Restricted Stock Units

The Board or its Compensation Committee may issue options, restricted stock, and restricted stock units pursuant to equity incentive plans that have been approved by Chembio’s stockholders.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

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+ Details

COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS

3 Months Ended

Mar. 31, 2022

COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS [Abstract]

COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS

NOTE 6 — COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS:

Concentrations:

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

	For the three months ended									Accounts Receivable as of
	March 31, 2022					March 31, 2021				March 31, 2022		December 31, 2021
	Product Sales		% of Product Sales			Product Sales		% of Product Sales
Customer 1	$	11,856,024		64	%	$	*		*	$	5,930,162	$	7,672,845

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

The following table discloses purchases the Company had to each vendor that purchased in excess of 10% of the Company’s net purchases for the periods indicated:

	For the three months ended										Accounts Payable as of
	March 31, 2022					March 31, 2021					March 31, 2022		December 31, 2021
	Purchases		% of Purchases			Purchases		% of Purchases
Vendor 1	$	2,323,605		34	%	$	*		*		$	224,500	$	*
Vendor 2		1,088,251		16	%		469,635		11	%		164,983		353,097

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.

Employment Contracts:

The Company has multi-year contracts with three key employees. The contracts call for salaries presently aggregating $1,178,000 per year. The contracts expire in December 2022 and December 31, 2024. The following table is a schedule of future minimum salary commitments:

2022	$	883,500
2023		383,000
2024		383,000

Benefit Plan:

Chembio has a 401(k) plan established for the Company’s employees whereby it matches 40% of the first 5% of salary (or up to 2% of salary) that an employee contributes to the plan. Matching contribution expenses totaled approximately $67,135 and $35,456 for the three months ended March 31, 2022 and 2021, 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 non-lease components for all of the Company’s facility leases.

The components of lease expense were as follows:

	Three Months Ended March 31
	2022		2021
Operating lease expense	$	403,385	$	408,466

Finance lease cost
Amortization of right-of-use assets	$	17,579	$	15,758
Interest on lease liabilities		4,686		4,944
Total finance lease expense	$	22,265	$	20,702

Supplemental cash flow information related to leases was as follows.

	Three Months Ended March 31
	2022		2021
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows for operating leases	$	360,878	$	347,871
Operating cash flows for finance leases		4,686		4,944
Financing cash flows for finance leases		16,930		14,282
Right-of-use assets obtained in exchange for lease obligations:
Finance leases		16,234		-

Supplemental balance sheet information related to leases was as follows:

	March 31, 2022			March 31, 2021
Finance Leases
Finance lease right of use asset	$	356,997		$	315,153
Accumulated depreciation		(166,471	)		(97,777	)
Finance lease right of use asset, net	$	190,526		$	217,376

Weighted Average Remaining Lease Term
Operating leases	7.4 years			8.6 years
Finance leases	2.8 years			3.5 years

Weighted Average Discount Rate
Operating leases		9.32	%		9.30	%
Finance leases		8.56	%		8.18	%

Maturities of lease liabilities were as follows.

	March 31, 2022				March 31, 2021
	Operating Leases		Finance Leases		Operating Leases		Finance Leases
2022	$	1,086,370	$	65,913	$	861,916	$	57,678
2023		1,221,017		87,884		1,057,757		76,904
2024		1,018,875		60,116		1,026,272		76,904
2025		1,049,442		16,731		1,018,875		49,136
2026		1,080,925		5,940		1,049,442		5,751
Thereafter		3,643,521		355		4,724,446		-
Total lease payments	$	9,100,150	$	236,939	$	9,738,708	$	266,373
Less: imputed interest		2,450,412		29,781		2,968,703		36,544
Total	$	6,649,738	$	207,158	$	6,770,005	$	229,829

Litigation:

SEC Investigation

The SEC is conducting a non-public, fact-finding investigation relating to the public offering of common stock that Chembio completed in May 2020 (the “May 2020 Offering”) and to the FDA’s revocation in June 2020 of an emergency use authorization for the DPP COVID-19 IgM/IgG system that was issued by the FDA in April 2020. Chembio received subpoenas from the SEC in July 2020 and April 2021 seeking the production of documents in connection with this investigation. In addition, the SEC delivered subpoenas in April 2021 to five of Chembio’s employees (including its three executive officers, who consist of its Chief Executive Officer and President, its former Executive Vice President and Chief Financial Officer, and its Executive Vice President and Chief Scientific and Technology Officer). An additional subpoena was issued in June 2021 to Chembio’s former Interim Chief Executive Officer and Executive Chair. Each subpoena requested the production of documents relating to the same matters as are the subject of the subpoenas Chembio received. Chembio and the six individuals are cooperating fully in the SEC’s investigation and expect to continue to do so.

The SEC’s letters transmitting the subpoenas expressly provide that the inquiry does not mean that the SEC or its staff have concluded that anyone has violated the federal securities laws or have a negative opinion of any person, entity or security. The Company cannot predict the scope, duration or outcome of the investigation or the impact, if any, of the investigation on its results of operations.

Legal Proceedings

Stockholder Litigation

Putative Stockholder Securities Class-Action Litigation

In 2020 four purported securities class-action lawsuits were filed in the United States District Court for the Eastern District of New York by alleged stockholders of Chembio:

•	Sergey Chernysh v. Chembio Diagnostics, Inc., Richard L. Eberly, and Gail S. Page, filed on June 18, 2020;

•	James Gowen v. Chembio Diagnostics, Inc., Richard L. Eberly, and Gail S. Page, filed on June 22, 2020;

•	Anthony Bailey v. Chembio Diagnostics, Inc. Richard J. Eberly, Gail S. Page, and Neil A. Goldman, filed on July 3, 2020; 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.

The plaintiffs in each of the above 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. (collectively, 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 the May 2020 Offering.

Chembio and the plaintiffs entered into Court-approved stipulations relieving Chembio and the other 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. By order entered December 29, 2020, Magistrate Judge Lindsay consolidated the cases and appointed the Special Situations Funds and Municipal Employees’ Retirement System of Michigan (together, the “Lead Plaintiffs”), 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 Lead Plaintiffs filed their Consolidated Amended Complaint (the “CAC”) on February 12, 2021. In summary, the CAC purported 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 FDA with respect to the DPP COVID-19 IgM/IgG System “was - or was at an increased risk of - being revoked.” The CAC named as defendants Chembio, Richard L. Eberly, Gail S. Page, Neil A. Goldman, Javan Esfandiari, Katherine L. Davis, Mary Lake Polan, John Potthoff (together, the “Chembio Defendants”) and the underwriters for the May 2020 Offering, Robert W. Baird & Co., Inc. and Dougherty & Company LLC (the “Underwriter Defendants”).

The CAC purported to assert five counts under the Securities Act and the Exchange Act. Counts I through III were 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 May 2020 Offering pursuant to Chembio’s shelf registration statement on Form S 3 (File No. 333-227398) and the related prospectus, as supplemented by a prospectus supplement dated May 7, 2020 (the “Securities Act Class”). Count I purported to allege a claim for violation of Section 11 of the Securities Act against all defendants other than Messrs. Eberly and Esfandiari. Count II purported to allege a claim for violation of Section 12 of the Securities Act against all defendants other than Messrs. Eberly and Esfandiari. Count III purported 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 alleged claims under the Exchange Act on behalf of a purported class consisting of all persons who purchased Chembio common stock on the open market from March 12, 2020 through June 16, 2020 (the “Exchange Act Class”). Count IV purported to allege a claim for violation of Section 10(b) of the Exchange Act and Rule 10b-5 thereunder against Chembio, Mr. Eberly, Ms. Page, Mr. Goldman and Mr. Esfandiari. Count V purported to allege a claim under Section 20(a) of the Exchange Act against Mr. Eberly, Ms. Page, Mr. Goldman and Mr. Esfandiari.

In their CAC, the Lead Plaintiffs sought, 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 sought 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 the 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 it advised the parties that it had determined a pre motion conference was not necessary and established a briefing schedule on the defendants’ anticipated motions to dismiss. However, the defendants subsequently agreed with the Lead Plaintiffs’ counsel to a modification of the schedule, which was then approved by the Court. Pursuant to that schedule, defendants’ motions and supporting papers were filed on March 26, 2021, the Lead Plaintiffs’ opposition papers were filed on April 16, 2021, and the defendants’ reply papers were filed on April 30, 2021.

The Court issued its Opinion and Order (the “Order”) on the defendants’ motions to dismiss on February 23, 2022. In its Order, the Court: (i) dismissed Counts I and II without prejudice as to all defendants named in those Counts except the Underwriter Defendants as to which Counts I and II were not dismissed; (ii) dismissed Count III without prejudice as to all defendants named in that Count; and (iii) dismissed Counts IV and V with prejudice as to all defendants named in those Counts. The Court gave Lead Plaintiffs fourteen days within which to attempt to replead their claims under the Securities Act against Chembio, Ms. Page, Mr. Goldman, Ms. Davis, Ms. Polan and Mr. Potthoff.

On March 4, 2022, Lead Plaintiffs filed a letter motion in which they advised the Court that they intended to file an amended complaint, but that they wished to first seek reconsideration of the Court’s February 23 order. They accordingly requested, and the Court granted, an adjournment of the deadline for filing an amended complaint until three business days after the Court’s ruling on Lead Plaintiffs’ anticipated motion for reconsideration. The Court also granted a request by the Underwriter Defendants to extend the time for them to file their answer to the CAC, and set May 2, 2022 as the date for the filing of that answer.

On March 7, 2022, Magistrate Judge John Wicks entered an order requiring that the parties meet and confer regarding the scheduling of discovery in the case, requiring that the parties submit a Proposed Scheduling Order by March 23, and setting a hearing (via zoom) on March 30. The Chembio Defendants filed a letter motion requesting that the Court adjourn the initial conference and suspend the other requirements in the March 7, 2022 order. Magistrate Judge Wicks granted the letter motion on March 14, and further ordered that the initial conference would be rescheduled “following the resolution of all preliminary dispositive issues.”

On March 9, 2022, Lead Plaintiffs filed a motion for partial reconsideration of the Court’s February 23 Order. In their motion, Lead Plaintiffs requested that the Court reconsider and reverse its dismissal of Counts IV and V with prejudice, and its dismissal of Counts I, II and III without prejudice. The Chembio Defendants filed their memorandum in opposition to this motion on March 23, 2022; Lead Plaintiffs filed their reply memorandum in support of the motion on March 30, 2022. The Court has not yet ruled upon the motion for partial reconsideration.

On April 26, 2022, the Court entered an order canceling the previously-set May 2 date by which the Underwriter Defendants were required to file their answer to the CAC, and providing that the Underwriter Defendants’ answer to an amended complaint shall be due within three weeks after such amended complaint has been served.

Putative Stockholder Derivative Litigation

On September 11, 2020, a putative stockholder derivative action 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 (the “Wong complaint”) was filed purportedly on Chembio’s behalf in the United States District Court for the Eastern District of New York. 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 the Company’s rapid COVID-19 antibody test in the proxy statement disseminated in advance of Chembio’s 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 Chembio, 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 Chembio, an award of damages to us, 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 Chembio’s corporate governance and internal procedures regarding compliance with laws. Pursuant to a stipulation by which the individual defendants named in the Wong complaint 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 action relating to the Wong complaint 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. At this stage of the litigation, the Company is not able to predict the probability of a favorable or unfavorable outcome.

On March 31, 2022, a second putative stockholder derivative action captioned Michelle Chen, 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 (the “Chen complaint”) was filed purportedly on behalf of Chembio in the Supreme Court for the State of New York, County of Suffolk. The Chen complaint purports to assert a claim for breach of fiduciary duty against the defendants based on ostensibly false and misleading statements and omissions concerning the Company’s rapid COVID-19 antibody test. The Chen complaint goes on to allege that the misconduct asserted in the complaint gave rise to the filing of the consolidated securities litigation described above.

Counsel for the defendants in the Chen action are engaged in discussions with counsel for Chen concerning a possible stay of the Chen action.

Employee Litigation

On March 19, 2021, John J. Sperzel III, Chembio’s former chief executive officer, filed a fifteen-count complaint in the United States District Court for the Eastern District of New York. The complaint was filed following the dismissal of an action previously filed by Mr. Sperzel in the United States District Court in Maine, which was dismissed for lack of personal jurisdiction over Chembio. In summary, the complaint filed in the Eastern District of New York alleges that Chembio wrongfully refused to allow Mr. Sperzel 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 allegedly vested as of the date of his separation from Chembio, on January 3, 2020. The complaint alleges that under the terms of the applicable stock incentive plans, Mr. Sperzel had thirty days after the date on which he ceased to qualify as an “Eligible Person” under the plans within which to exercise the options, and asserts that by reason of his alleged continued service to us, he remained an “Eligible Person” and ostensibly retained the right to exercise the options. The Compensation Committee of the Board determined that the options expired on February 3, 2020, thirty days after Mr. Sperzel’s separation from Chembio, and that a purported attempt by Mr. Sperzel to exercise the options after that date was not valid.

Count I of the complaint purports to allege that Chembio breached Mr. Sperzel’s separation agreement by refusing to allow him to exercise the stock options. Counts II through XI of the complaint purport to allege claims for breach of each of ten separate stock option agreements, collectively asserting damages of “at least” $3,190,198. Count XII of the complaint alleges a breach of Mr. Sperzel’s separation agreement based on Chembio’s purported failure to pay Mr. Sperzel consulting fees to which he claims to be entitled for consulting services allegedly performed following his separation. Count XIII of the complaint alleges a claim for breach of an implied covenant of good faith and fair dealing under Nevada common law based on the allegation that Chembio prevented Mr. Sperzel from obtaining the benefits of the stock option agreements and separation agreement. Mr. Sperzel alleges that he suffered damages in excess of $3 million as a result of the purported breach of the covenant of good faith and fair dealing. Count XIV of the complaint purports to assert a claim for quantum meruit, alleging that “it is reasonable for Sperzel to expect payment in exchange for ... services” he allegedly provided to us and, based on allegations that upon his separation Mr. Sperzel was not informed as to the pending expiration of the stock options he later sought to exercise, that Chembio has been unjustly enriched. Finally, Count XV of the complaint seeks a declaratory judgment that Mr. Sperzel is relieved from performance under his separation agreement due to asserted material breaches of the agreement based on the allegations summarized above. The complaint seeks compensatory damages in an unspecified amount, a declaration, as described above, and an award of Mr. Sperzel’s costs and expenses in the litigation, including reasonable attorneys’ fees, expert costs and disbursements. The complaint requests a trial by jury. In his initial disclosures served in discovery, Mr. Sperzel claims entitlement to recover damages in a total amount not less than $10 million, together with prejudgment interest at the rate of 9% per annum.

On May 20, 2021, Chembio filed its answer and affirmative defenses denying the material allegations of Mr. Sperzel’s complaint. Chembio and Mr. Sperzel are presently engaged in discovery. Under the present case schedule, all fact discovery was completed on April 28, 2022, and the parties are currently in the midst of an additional period of expert witness discovery, concluding on June 28, 2022. At this stage of the litigation, the Company is not able to predict the probability of a favorable or unfavorable outcome.

Other

From time to time the Company may become involved in legal proceedings or may be subject to claims arising in the ordinary course of its business. Although the results of litigation and claims cannot be predicted with certainty, the Company currently believes that the final outcome of these ordinary course matters will not have a material adverse effect on its business, operating results, financial condition or cash flows. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors.

LONG-TERM DEBT	3 Months Ended
LONG-TERM DEBT	Mar. 31, 2022
LONG-TERM DEBT [Abstract]
LONG-TERM DEBT	NOTE 7 — LONG-TERM DEBT: On September 3, 2019, Chembio 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, Chembio may use the proceeds (i) for general working capital purposes and other permitted corporate purposes, (ii) to refinance certain of Chembio’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, Chembio’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 March 31, 2022 the interest rate was 11.25%. No principal repayments are due under the Credit Agreement prior to September 30, 2022, unless Chembio 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 March 31, 2022, the loan balance, net of unamortized discounts and debt issuance costs, was $18.9 million, and Chembio was in compliance with its loan covenants.

EQUITY INCENTIVE PLAN

3 Months Ended

Mar. 31, 2022

EQUITY INCENTIVE PLAN [Abstract]

EQUITY INCENTIVE PLAN

NOTE 8 — EQUITY INCENTIVE PLAN:

(a)

Equity Plans:

Effective June 19, 2014, Chembio’s stockholders voted to approve the 2014 Stock Incentive Plan (the “2014 Plan”), with 800,000 shares of common stock available to be issued. Under the terms of the 2014 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 Equity Award Units. The awards vest at such times and under such conditions as determined by the Board or its Compensation Committee. Cumulatively through March 31, 2022, there were 732,064 Equity Award Units expired, forfeited or exercised. At March 31, 2022, 46,875 Equity Award Units were outstanding and 21,061 shares were not issued. All shares that expired, forfeited or were not issued rolled over into the 2019 Plan. No Equity Award Units remain available to be issued under the 2014 Plan.

Effective June 18, 2019, Chembio’s stockholders voted to approve the 2019 Omnibus Incentive Plan (the “2019 Plan”), with 2,400,000 shares of common stock available to be issued. At the Annual Stockholder Meeting on June 25, 2021, Chembio’s stockholders voted to approve an increase to the shares of common stock issuable under the SIP by 2,400,000 to 4,800,000. In addition, shares of common stock underlying any outstanding award granted under the 2019 Plan that, following the effective date of the 2019 Plan, expire, or are 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, performance stock units or other stock-based awards under the 2019 Plan (collectively, “2019 Equity Units”). The 2019 Equity Units become vested at such times and under such conditions as determined by the Board or its Compensation Committee. Cumulatively through March 31, 2022, 866,709 2019 Equity Units have been cancelled or forfeited. At March 31, 2022, 4,915,279 2019 Equity Units were outstanding, and 83,234 2019 Equity Units were available to be awarded.

(b)

Stock Compensation Expense:

Stock-based compensation expense (net of recovery) recognized in the condensed consolidated statements of operations was classified as follows:

	For the three months ended March 31
	2022		2021
Cost of product sales	$	54,250	$	28,768
Research and development expenses		91,189		90,920
Selling, general and administrative expenses		605,464		460,101
	$	750,903	$	579,789

The weighted-average assumptions made in calculating the fair values of options are as follows:

	For the three months ended March 31, 2021
Expected term (in years)		6.0
Expected volatility		91.40	%
Expected dividend yield		N/A
Risk-free interest rate		1.91	%

The following table provides stock option activity for the three months ended March 31, 2022:

Stock Options	Number of Shares	Weighted Average Exercise Price per Share		Weighted Average Remaining Contract Term	Aggregate Intrinsic Value
Outstanding at December 31, 2021	1,600,372	$	4.18	6.59 years	$	-

Granted	2,358,539		1.23			-
Exercised	-		-			-
Forfeited	14,883		2.42			-
Expired	183,241		5.63
Outstanding at March 31, 2022	3,760,787	$	2.27	8.65 years	$	-
Exercisable at March 31, 2022	565,215	$	3.68	5.89 years	$	-

The following table summarizes information about stock options outstanding at March 31, 2022:

	Stock Options Outstanding								Stock Options Exercisable
Range of Exercise Prices	Number of Shares		Average Remaining Contract Term (Year)		Weighted Average Exercise Price		Aggregate Intrinsic Value		Number of Shares		Weighted Average Exercise Price		Aggregate Intrinsic Value
_1 to 2.79999		2,863,910		8.83	$	1.44	$	-		317,758	$	2.36	$	-
2.8 to 4.59999		30,795		9.19		3.05		-		-		-		-
4.6 to 6.39999		819,207		8.43		4.81		-		209,957		4.88		-
6.4 to 8.19999		46,875		1.11		8.15		-		37,500		8.15		-
Total		3,760,787		8.65	$	2.27	$	-		565,215	$	3.69	$	-

As of March 31, 2022, there was $3,073,502 of net unrecognized compensation cost related to stock options that had not vested, which is expected to be recognized over a weighted-average period of approximately 3.32 years. The total fair value of shares vested during the three months ended March 31, 2022 and 2021 was $693,290 and $188,179, respectively.

The following table summarizes information about restricted stock, restricted stock units and performance stock units outstanding as of March 31, 2022:

	Number of Shares & Units		Weighted Average Grant Date Fair Value
Outstanding at December 31, 2021		705,325	$	3.34

Granted		1,210,448		0.76
Vested		167,782		3.60
Forfeited		8,047		2.31
Outstanding at March 31, 2022		1,739,944	$	1.52

As of March 31, 2022, there was $2,120,646 of net unrecognized compensation cost related to restricted stock and restricted stock units that had not vested, which is expected to be recognized over a weighted average period of approximately 2.50 years.

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY

3 Months Ended

Mar. 31, 2022

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract]

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY

NOTE 9 — 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. Net product revenue by geographic area were as follows:

	For the three months ended March 31
	2022		2021
Africa	$	767,352	$	1,344,858
Asia		15,558		216,954
Europe & Middle East		717,908		1,493,734
Latin America		12,545,054		258,019
United States		4,481,584		711,097
	$	18,527,456	$	4,024,662

Property, plant and equipment by geographic area were as follows at:

	March 31, 2022		December 31, 2021
Asia	$	85,351	$	86,041
Europe & Middle East		101,231		113,883
Latin America		58,685		36,224
United States		8,169,046		8,320,625
	$	8,414,313	$	8,556,773

- 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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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8933-108599

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8736-108599

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 42
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e9054-108599

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 15
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8657-108599

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 21
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8721-108599

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-URI http://asc.fasb.org/topic&trid=2134510

+ Details

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

3 Months Ended

Mar. 31, 2022

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract]

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

NOTE 10 — ACCOUNTS PAYABLE AND ACCRUED LIABILITIES:

Accounts payable and accrued liabilities consisted of:

	March 31, 2022		December 31, 2021
Accounts payable – suppliers	$	5,622,558	$	7,745,592
Accrued commissions and royalties		1,510,865		1,359,691
Accrued payroll		494,653		494,258
Accrued vacation		657,008		421,416
Accrued bonuses		544,567		1,378,706
Accrued professional fees		893,745		522,935
Accrued expenses – other		819,455		1,205,395
TOTAL	$	10,542,851	$	13,127,993

GOODWILL AND INTANGIBLE ASSETS

3 Months Ended

Mar. 31, 2022

GOODWILL AND INTANGIBLE ASSETS [Abstract]

GOODWILL AND INTANGIBLE ASSETS

NOTE 11 — GOODWILL AND INTANGIBLE ASSETS:

The following table reflects changes in goodwill:

Beginning balance at December 31, 2021	$	3,022,787
Impairment		(3,033,565	)
Change in foreign currency exchange rate		10,778
Balance at March 31, 2022	$	-

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.

The quantitative goodwill impairment test is performed using a one-step process. The process is to compare the fair value of a reporting unit with its carrying amount. If the fair value of a reporting unit exceeds its carrying amount, goodwill of the reporting unit is not impaired. If the carrying amount of a reporting unit exceeds its fair value, goodwill of the reporting unit is impaired, and an impairment loss is recognized in an amount equal to that excess.

The Company operates as a single operating segment and has one reporting unit. As of March 31, 2022, the Company determined indicators of impairment existed. As a result, the Company recognized an impairment loss of its goodwill totaling $3.0 million.

OTHER MATTERS	3 Months Ended
OTHER MATTERS	Mar. 31, 2022
OTHER MATTERS [Abstract]
OTHER MATTERS	NOTE 12 — OTHER MATTERS: On March 28, 2022, Chembio Diagnostics GmbH, Chembio’s German subsidiary formed under the laws of the Federal Republic of Germany, successfully withdrew its petition for insolvency filed in February 2022 in the Charlottenburg District Court (“Amtsgericht Charlottenburg“) in Berlin, Germany. The subsidiary has taken various measures to improve profitability, including a viable business plan, and the Company has provided liquidity and other support to continue the operations.

SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Mar. 31, 2022

SIGNIFICANT ACCOUNTING POLICIES [Abstract]

Basis of Presentation

(a)

Basis of presentation:

Going Concern Considerations

•	Focus on higher margin business in growth markets

•	Lower manufacturing costs

•	Reduce infrastructure costs

•	Strategic review of non-core businesses and assets:

•

•	Although the Company has entered into agreements to distribute third-party COVID-19 products in the United States, its ability to sell those products could be constrained because of staffing and supply chain limitations affecting the suppliers of those products.

Fair Value of Financial Instruments

(c)

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:

Cash and cash equivalents are defined as short-term, highly liquid investments, such as money market funds, with original maturities of three months or less at date of purchase.

Loss Per Share

(e)

Loss Per Share:

Income Taxes

(f)

Income Taxes:

Recently Issued Accounting Standards Affecting the Company

(g)

Recently Issued Accounting Standards Affecting the Company:

Recently Adopted

ASU 2021-10 - Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance

Not Yet Adopted

ASU 2021-08—Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers

- Definition

Disclosure of accounting policy for income taxes, which may include its accounting policies for recognizing and measuring deferred tax assets and liabilities and related valuation allowances, recognizing investment tax credits, operating loss carryforwards, tax credit carryforwards, and other carryforwards, methodologies for determining its effective income tax rate and the characterization of interest and penalties in the financial statements.

+ References + Details

REVENUE (Tables)

3 Months Ended

Mar. 31, 2022

REVENUE [Abstract]

Disaggregation of Revenue

The following table disaggregates Total Revenues by revenue type:

	March 31, 2022						March 31, 2021
	Exchange Transactions		Non-Exchange Transactions		Total		Exchange Transactions		Non-Exchange Transactions		Total
Net product revenue	$	18,527,456	$	-	$	18,527,456	$	4,024,662	$	-	$	4,024,662
R&D Revenue		18,173		-		18,173		1,106,639		-		1,106,639
Government grant revenue		–		–		–		–		3,350,000		3,350,000
License and royalty revenue		270,982		-		270,982		243,058		-		243,058
	$	18,816,611	$	-	$	18,816,611	$	5,374,359	$	3,350,000	$	8,724,359

The following table disaggregates Total Revenues by geographic location:

	For the three months ended
	March 31, 2022		March 31, 2021
Africa	$	767,352	$	1,344,858
Asia		15,558		216,954
Europe & Middle East		723,745		2,600,274
Latin America		12,557,390		258,019
United States		4,752,566		4,304,254
	$	18,816,611	$	8,724,359

INVENTORY (Tables)

3 Months Ended

Mar. 31, 2022

INVENTORY [Abstract]

Inventories

Inventories are presented net of reserves and consist of the following at:

	March 31, 2022		December 31, 2021
Raw materials	$	7,197,257	$	7,306,095
Work in process		1,932,069		3,556,878
Finished goods		2,714,795		2,057,478
	$	11,844,121	$	12,920,451

COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS (Tables)

3 Months Ended

Mar. 31, 2022

COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS [Abstract]

Customer and Purchase Concentration Risks

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

	For the three months ended									Accounts Receivable as of
	March 31, 2022					March 31, 2021				March 31, 2022		December 31, 2021
	Product Sales		% of Product Sales			Product Sales		% of Product Sales
Customer 1	$	11,856,024		64	%	$	*		*	$	5,930,162	$	7,672,845

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

The following table discloses purchases the Company had to each vendor that purchased in excess of 10% of the Company’s net purchases for the periods indicated:

	For the three months ended										Accounts Payable as of
	March 31, 2022					March 31, 2021					March 31, 2022		December 31, 2021
	Purchases		% of Purchases			Purchases		% of Purchases
Vendor 1	$	2,323,605		34	%	$	*		*		$	224,500	$	*
Vendor 2		1,088,251		16	%		469,635		11	%		164,983		353,097

Future Minimum Salary Commitment

The following table is a schedule of future minimum salary commitments:

2022	$	883,500
2023		383,000
2024		383,000

Components of Lease Expense

The components of lease expense were as follows:

	Three Months Ended March 31
	2022		2021
Operating lease expense	$	403,385	$	408,466

Finance lease cost
Amortization of right-of-use assets	$	17,579	$	15,758
Interest on lease liabilities		4,686		4,944
Total finance lease expense	$	22,265	$	20,702

Supplemental Cash Flow Information Related to Leases

Supplemental cash flow information related to leases was as follows.

	Three Months Ended March 31
	2022		2021
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows for operating leases	$	360,878	$	347,871
Operating cash flows for finance leases		4,686		4,944
Financing cash flows for finance leases		16,930		14,282
Right-of-use assets obtained in exchange for lease obligations:
Finance leases		16,234		-

Supplemental Balance Sheet Information Related to Leases

Supplemental balance sheet information related to leases was as follows:

	March 31, 2022			March 31, 2021
Finance Leases
Finance lease right of use asset	$	356,997		$	315,153
Accumulated depreciation		(166,471	)		(97,777	)
Finance lease right of use asset, net	$	190,526		$	217,376

Weighted Average Remaining Lease Term
Operating leases	7.4 years			8.6 years
Finance leases	2.8 years			3.5 years

Weighted Average Discount Rate
Operating leases		9.32	%		9.30	%
Finance leases		8.56	%		8.18	%

Maturities of Lease Liabilities

Maturities of lease liabilities were as follows.

	March 31, 2022				March 31, 2021
	Operating Leases		Finance Leases		Operating Leases		Finance Leases
2022	$	1,086,370	$	65,913	$	861,916	$	57,678
2023		1,221,017		87,884		1,057,757		76,904
2024		1,018,875		60,116		1,026,272		76,904
2025		1,049,442		16,731		1,018,875		49,136
2026		1,080,925		5,940		1,049,442		5,751
Thereafter		3,643,521		355		4,724,446		-
Total lease payments	$	9,100,150	$	236,939	$	9,738,708	$	266,373
Less: imputed interest		2,450,412		29,781		2,968,703		36,544
Total	$	6,649,738	$	207,158	$	6,770,005	$	229,829

EQUITY INCENTIVE PLAN (Tables)

3 Months Ended

Mar. 31, 2022

EQUITY INCENTIVE PLAN [Abstract]

Stock-Based Compensation Expense (Net of Recovery) Recognized

Stock-based compensation expense (net of recovery) recognized in the condensed consolidated statements of operations was classified as follows:

	For the three months ended March 31
	2022		2021
Cost of product sales	$	54,250	$	28,768
Research and development expenses		91,189		90,920
Selling, general and administrative expenses		605,464		460,101
	$	750,903	$	579,789

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 three months ended March 31, 2021
Expected term (in years)		6.0
Expected volatility		91.40	%
Expected dividend yield		N/A
Risk-free interest rate		1.91	%

Stock Option Activity

The following table provides stock option activity for the three months ended March 31, 2022:

Stock Options	Number of Shares	Weighted Average Exercise Price per Share		Weighted Average Remaining Contract Term	Aggregate Intrinsic Value
Outstanding at December 31, 2021	1,600,372	$	4.18	6.59 years	$	-

Granted	2,358,539		1.23			-
Exercised	-		-			-
Forfeited	14,883		2.42			-
Expired	183,241		5.63
Outstanding at March 31, 2022	3,760,787	$	2.27	8.65 years	$	-
Exercisable at March 31, 2022	565,215	$	3.68	5.89 years	$	-

Stock Options Outstanding

The following table summarizes information about stock options outstanding at March 31, 2022:

	Stock Options Outstanding								Stock Options Exercisable
Range of Exercise Prices	Number of Shares		Average Remaining Contract Term (Year)		Weighted Average Exercise Price		Aggregate Intrinsic Value		Number of Shares		Weighted Average Exercise Price		Aggregate Intrinsic Value
_1 to 2.79999		2,863,910		8.83	$	1.44	$	-		317,758	$	2.36	$	-
2.8 to 4.59999		30,795		9.19		3.05		-		-		-		-
4.6 to 6.39999		819,207		8.43		4.81		-		209,957		4.88		-
6.4 to 8.19999		46,875		1.11		8.15		-		37,500		8.15		-
Total		3,760,787		8.65	$	2.27	$	-		565,215	$	3.69	$	-

Summary of Restricted Stock and Restricted Stock Units Outstanding

The following table summarizes information about restricted stock, restricted stock units and performance stock units outstanding as of March 31, 2022:

	Number of Shares & Units		Weighted Average Grant Date Fair Value
Outstanding at December 31, 2021		705,325	$	3.34

Granted		1,210,448		0.76
Vested		167,782		3.60
Forfeited		8,047		2.31
Outstanding at March 31, 2022		1,739,944	$	1.52

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY (Tables)

3 Months Ended

Mar. 31, 2022

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract]

Product Revenue by Geographic Area

	For the three months ended March 31
	2022		2021
Africa	$	767,352	$	1,344,858
Asia		15,558		216,954
Europe & Middle East		717,908		1,493,734
Latin America		12,545,054		258,019
United States		4,481,584		711,097
	$	18,527,456	$	4,024,662

Long-lived Assets by Geographic Area

Property, plant and equipment by geographic area were as follows at:

	March 31, 2022		December 31, 2021
Asia	$	85,351	$	86,041
Europe & Middle East		101,231		113,883
Latin America		58,685		36,224
United States		8,169,046		8,320,625
	$	8,414,313	$	8,556,773

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Tables)

3 Months Ended

Mar. 31, 2022

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract]

Accounts Payable and Accrued Liabilities

Accounts payable and accrued liabilities consisted of:

	March 31, 2022		December 31, 2021
Accounts payable – suppliers	$	5,622,558	$	7,745,592
Accrued commissions and royalties		1,510,865		1,359,691
Accrued payroll		494,653		494,258
Accrued vacation		657,008		421,416
Accrued bonuses		544,567		1,378,706
Accrued professional fees		893,745		522,935
Accrued expenses – other		819,455		1,205,395
TOTAL	$	10,542,851	$	13,127,993

GOODWILL AND INTANGIBLE ASSETS (Tables)

3 Months Ended

Mar. 31, 2022

GOODWILL AND INTANGIBLE ASSETS [Abstract]

Changes in Goodwill

The following table reflects changes in goodwill:

Beginning balance at December 31, 2021	$	3,022,787
Impairment		(3,033,565	)
Change in foreign currency exchange rate		10,778
Balance at March 31, 2022	$	-

SIGNIFICANT ACCOUNTING POLICIES, Going Concern Considerations (Details) - USD ($) $ in Millions	12 Months Ended
	Mar. 31, 2023	Jun. 30, 2022
Forecast [Member]
Credit Agreement [Abstract]
Covenant amount, revenue	$ 48.8	$ 43.8

SIGNIFICANT ACCOUNTING POLICIES, Fair Value of Financial Instruments (Details) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	$ 24,399,388	$ 28,772,892
Level 2 [Member]
Fair Value of Financial Instruments [Abstract]
Fair value of total debt	20,000,000.0	20,000,000.0
Carrying value	18,900,000	18,800,000
Money Market Funds [Member] \| Level 1 [Member]
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	$ 17,100,000	$ 25,000,000.0

- Definition

Amount, after unamortized (discount) premium and debt issuance costs, of long-term debt. Includes, but not limited to, notes payable, bonds payable, debentures, mortgage loans and commercial paper. Excludes capital lease obligations.

+ References + Details

SIGNIFICANT ACCOUNTING POLICIES, Loss Per Share (Details) - shares	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Options [Member]
Loss Per Share [Abstract]
Antidilutive securities excluded from calculation of diluted earnings per share (in shares)	3,760,787	1,848,286
Restricted Stock [Member]
Loss Per Share [Abstract]
Antidilutive securities excluded from calculation of diluted earnings per share (in shares)	1,739,944	847,795

SIGNIFICANT ACCOUNTING POLICIES, Income Taxes (Details)	3 Months Ended
SIGNIFICANT ACCOUNTING POLICIES, Income Taxes (Details)	Mar. 31, 2022	Mar. 31, 2021
Income Taxes [Abstract]
Effective tax rate	0.10%	1.60%

REVENUE (Details) - USD ($)	3 Months Ended
REVENUE (Details) - USD ($)	Mar. 31, 2022	Mar. 31, 2021
Disaggregation of Revenue [Abstract]
Revenues	$ 18,816,611	$ 8,724,359
Africa [Member]
Disaggregation of Revenue [Abstract]
Revenues	767,352	1,344,858
Asia [Member]
Disaggregation of Revenue [Abstract]
Revenues	15,558	216,954
Europe & Middle East [Member]
Disaggregation of Revenue [Abstract]
Revenues	723,745	2,600,274
Latin America [Member]
Disaggregation of Revenue [Abstract]
Revenues	12,557,390	258,019
United States [Member]
Disaggregation of Revenue [Abstract]
Revenues	4,752,566	4,304,254
Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	18,816,611	5,374,359
Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	0	3,350,000
Net Product Revenue [Member]
Disaggregation of Revenue [Abstract]
Revenues	18,527,456	4,024,662
Net Product Revenue [Member] \| Africa [Member]
Disaggregation of Revenue [Abstract]
Revenues	767,352	1,344,858
Net Product Revenue [Member] \| Asia [Member]
Disaggregation of Revenue [Abstract]
Revenues	15,558	216,954
Net Product Revenue [Member] \| Europe & Middle East [Member]
Disaggregation of Revenue [Abstract]
Revenues	717,908	1,493,734
Net Product Revenue [Member] \| Latin America [Member]
Disaggregation of Revenue [Abstract]
Revenues	12,545,054	258,019
Net Product Revenue [Member] \| United States [Member]
Disaggregation of Revenue [Abstract]
Revenues	4,481,584	711,097
Net Product Revenue [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	18,527,456	4,024,662
Net Product Revenue [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	0	0
R&D Revenue [Member]
Disaggregation of Revenue [Abstract]
Revenues	18,173	1,106,639
R&D Revenue [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	18,173	1,106,639
R&D Revenue [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	0	0
Government Grant Revenue [Member]
Disaggregation of Revenue [Abstract]
Revenues	0	3,350,000
Government Grant Revenue [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	0	0
Government Grant Revenue [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	0	3,350,000
License and Royalty Revenue [Member]
Disaggregation of Revenue [Abstract]
Revenues	270,982	243,058
License and Royalty Revenue [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	270,982	243,058
License and Royalty Revenue [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	$ 0	$ 0

INVENTORY (Details) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
INVENTORY [Abstract]
Raw materials	$ 7,197,257	$ 7,306,095
Work in process	1,932,069	3,556,878
Finished goods	2,714,795	2,057,478
Inventories	$ 11,844,121	$ 12,920,451

STOCKHOLDERS' EQUITY (Details) - shares	3 Months Ended
STOCKHOLDERS' EQUITY (Details) - shares	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Common Stock [Abstract]
Number of stock options exercised under the plan (in shares)	0	0
Preferred Stock [Abstract]
Preferred stock - shares authorized (in shares)	10,000,000		10,000,000
Preferred stock - shares outstanding (in shares)	0		0
Treasury Stock [Abstract]
Treasury stock, shares (in shares)	48,057		48,057

COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS (Details)

3 Months Ended

12 Months Ended

Mar. 19, 2021

Claim

Jan. 03, 2020

USD ($)

Mar. 31, 2022

USD ($)

KeyEmployee

Applicants

Claim

Mar. 31, 2021

USD ($)

Dec. 31, 2020

Lawsuit

Dec. 31, 2021

USD ($)

Concentrations [Abstract]

Net product revenue

$ 18,816,611

$ 8,724,359

Accounts Receivable

$ 9,879,954

$ 11,441,107

Employment Contracts [Abstract]

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

Aggregate annual salaries of employment contracts

$ 1,178,000

Contract one, expiration date

Dec. 31, 2022

Contract two expiration date

Dec. 31, 2024

Future minimum salary commitments [Abstract]

2022

$ 883,500

2023

383,000

2024

$ 383,000

Benefit Plan [Abstract]

Percentage of employer's matching contribution

40.00%

$ 67,135

35,456

Components of Lease Expense [Abstract]

Operating lease expense

403,385

408,466

Finance lease cost [Abstract]

Amortization of right-of-use assets

17,579

15,758

Interest on lease liabilities

4,686

4,944

Total finance lease expense

22,265

20,702

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

Operating cash flows for operating leases

360,878

347,871

Operating cash flows for finance leases

4,686

4,944

Financing cash flows for finance leases

16,930

14,282

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

Finance leases

16,234

Finance Leases [Abstract]

Finance lease right-of-use asset

356,997

315,153

Accumulated depreciation

(166,471)

(97,777)

Finance lease right-of-use asset, net

$ 190,526

$ 217,376

191,870

Weighted Average Remaining Lease Term [Abstract]

Operating leases

7 years 4 months 24 days

8 years 7 months 6 days

Finance leases

2 years 9 months 18 days

3 years 6 months

Weighted Average Discount Rate [Abstract]

Operating leases

9.32%

9.30%

Finance leases

8.56%

8.18%

Maturities of Operating Lease Liabilities [Abstract]

2022

$ 1,086,370

$ 861,916

2023

1,221,017

1,057,757

2024

1,018,875

1,026,272

2025

1,049,442

1,018,875

2026

1,080,925

1,049,442

Thereafter

3,643,521

4,724,446

Total lease payments

9,100,150

9,738,708

Less: imputed interest

2,450,412

2,968,703

Total

6,649,738

6,770,005

Maturities of Finance Lease Liabilities [Abstract]

2022

65,913

57,678

2023

87,884

76,904

2024

60,116

76,904

2025

16,731

49,136

2026

5,940

5,751

Thereafter

355

Total lease payments

236,939

266,373

Less: imputed interest

29,781

36,544

Total

$ 207,158

229,829

Stockholder Litigation [Abstract]

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

Period within which lead plaintiffs can replead their claims

14 days

Employee Litigation [Abstract]

Number of filed complaints | Claim

Exercise price of stock options

$ 943,126

Vested shares exercisable (in shares) | shares

266,666

Term to exercise stock options

30 days

Number of complaint purport to allege claims for breach of each of separate stock option agreements | Claim

Loss contingency, asserting damages amount

$ 3,190,198

Loss contingency, asserting damages excess amount

3,000,000

Loss contingency, claims entitlement to recover damages amount

$ 10,000,000

Prejudgment interest rate

9.00%

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

Concentrations [Abstract]

Accounts Receivable

$ 5,930,162

7,672,845

Supplier Concentration Risk [Member] | Vendor 1 [Member]

Concentrations [Abstract]

Accounts Payable

224,500

^[1]

Supplier Concentration Risk [Member] | Vendor 2 [Member]

Concentrations [Abstract]

Accounts Payable

$ 164,983

$ 353,097

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 product revenue

$ 11,856,024

^[1]

Percentage of product sales

64.00%

^[1]

Purchases [Member] | Supplier Concentration Risk [Member] | Vendor 1 [Member]

Concentrations [Abstract]

Percentage of product sales

34.00%

^[1]

Purchases

$ 2,323,605

^[1]

Purchases [Member] | Supplier Concentration Risk [Member] | Vendor 2 [Member]

Concentrations [Abstract]

Percentage of product sales

16.00%

11.00%

Purchases

$ 1,088,251

$ 469,635

[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) - Senior Secured Term Loan Credit Facility [Member] - USD ($)		3 Months Ended
	Sep. 03, 2019	Mar. 31, 2022
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		$ 18,900,000
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%

EQUITY INCENTIVE PLAN, Summary (Details) - USD ($)		3 Months Ended		12 Months Ended
EQUITY INCENTIVE PLAN, Summary (Details) - USD ($)	Jun. 25, 2021	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021	Jun. 18, 2019	Jun. 19, 2014
Stock Compensation Expense [Abstract]
Allocated share-based compensation expense		$ 750,903	$ 579,789
Stock Options, Additional Disclosure [Abstract]
Outstanding, aggregate intrinsic value, end of period		0
Exercisable, aggregate intrinsic value, end of period		0
Cost of Product Sales [Member]
Stock Compensation Expense [Abstract]
Allocated share-based compensation expense		54,250	28,768
Research and Development Expenses [Member]
Stock Compensation Expense [Abstract]
Allocated share-based compensation expense		91,189	90,920
Selling, General and Administrative Expenses [Member]
Stock Compensation Expense [Abstract]
Allocated share-based compensation expense		$ 605,464	$ 460,101
Stock Options [Member]
Assumptions Made in Calculating Fair Values of Options [Abstract]
Expected term		6 years
Expected volatility		91.40%
Expected dividend yield
Risk-free interest rate		1.91%
Stock Options, Number of Shares [Roll forward]
Outstanding, beginning of period (in shares)		1,600,372
Granted (in shares)		2,358,539
Exercised (in shares)		0
Forfeited (in shares)		14,883
Expired (in shares)		183,241
Outstanding, end of period (in shares)		3,760,787		1,600,372
Exercisable, end of period (in shares)		565,215
Stock Options, Weighted Average Exercise Price per Share [Roll Forward]
Outstanding, beginning of period (in dollars per share)		$ 4.18
Granted (in dollars per share)		1.23
Exercised (in dollars per share)		0
Forfeited (in dollars per share)		2.42
Expired (in dollars per share)		5.63
Outstanding, end of period (in dollars per share)		2.27		$ 4.18
Exercisable, end of period (in dollars per share)		$ 3.68
Stock Options, Additional Disclosure [Abstract]
Outstanding, weighted average remaining contract term		8 years 7 months 24 days		6 years 7 months 2 days
Exercisable, weighted average remaining contract term		5 years 10 months 20 days
Outstanding, aggregate intrinsic value, beginning of period		$ 0
Granted, aggregate intrinsic value		0
Exercised, aggregate intrinsic value		0
Forfeited, aggregate intrinsic value		0
Outstanding, aggregate intrinsic value, end of period		0		$ 0
Exercisable, aggregate intrinsic value, end of period		$ 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)		732,064
Options still available to be issued (in shares)		0
Stock Options, Number of Shares [Roll forward]
Outstanding, end of period (in shares)		46,875
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)	4,800,000				2,400,000
Increase in number of shares authorized (in shares)	2,400,000
Number of stock options expired, forfeited or exercised under the plan (in shares)		866,709
Options still available to be issued (in shares)		83,234
Stock Options, Number of Shares [Roll forward]
Outstanding, end of period (in shares)		4,915,279
2014 & 2019 Stock Incentive Plan [Member] \| Stock Options [Member]
Stock Options, Number of Shares [Roll forward]
Outstanding, end of period (in shares)		21,061

EQUITY INCENTIVE PLAN, Stock Options (Details) - USD ($)		3 Months Ended
	Jan. 03, 2020	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Stock Options Outstanding [Abstract]
Shares outstanding (in shares)		3,760,787
Average remaining contract term		8 years 7 months 24 days
Weighted average exercise price (in dollars per share)		$ 2.27
Aggregate intrinsic value		$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares)		565,215
Weighted average exercise price (in dollars per share)		$ 3.69
Aggregate intrinsic value		$ 0
Total fair value of stock options vested during period	$ 943,126
Stock Options [Member]
Stock Options Outstanding [Abstract]
Aggregate intrinsic value		0		$ 0
Stock Options Exercisable [Abstract]
Aggregate intrinsic value		0
Net unrecognized compensation cost		$ 3,073,502
Weighted average period for recognition of net unrecognized compensation cost		3 years 3 months 25 days
Total fair value of stock options vested during period		$ 693,290	$ 188,179
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)		2,863,910
Average remaining contract term		8 years 9 months 29 days
Weighted average exercise price (in dollars per share)		$ 1.44
Aggregate intrinsic value		$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares)		317,758
Weighted average exercise price (in dollars per share)		$ 2.36
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)		30,795
Average remaining contract term		9 years 2 months 8 days
Weighted average exercise price (in dollars per share)		$ 3.05
Aggregate intrinsic value		$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares)		0
Weighted average exercise price (in dollars per share)		$ 0
Aggregate intrinsic value		$ 0
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)		819,207
Average remaining contract term		8 years 5 months 4 days
Weighted average exercise price (in dollars per share)		$ 4.81
Aggregate intrinsic value		$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares)		209,957
Weighted average exercise price (in dollars per share)		$ 4.88
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)		46,875
Average remaining contract term		1 year 1 month 9 days
Weighted average exercise price (in dollars per share)		$ 8.15
Aggregate intrinsic value		$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares)		37,500
Weighted average exercise price (in dollars per share)		$ 8.15
Aggregate intrinsic value		$ 0

EQUITY INCENTIVE PLAN, Restricted Stock and Restricted Stock Units (Details) - Restricted Stock, Restricted Stock Units, and Performance Stock Units [Member]	3 Months Ended
	Mar. 31, 2022 USD ($) $ / shares shares
Number of Shares & Units [Abstract]
Outstanding, beginning of period (in shares) \| shares	705,325
Granted (in shares) \| shares	1,210,448
Vested (in shares) \| shares	167,782
Forfeited (in shares) \| shares	8,047
Outstanding, end of period (in shares) \| shares	1,739,944
Weighted Average Grant Date Fair Value [Abstract]
Outstanding, beginning of period (in dollars per share) \| $ / shares	$ 3.34
Granted (in dollars per share) \| $ / shares	0.76
Vested (in dollars per share) \| $ / shares	3.60
Forfeited (in dollars per share) \| $ / shares	2.31
Outstanding, end of period (in dollars per share) \| $ / shares	$ 1.52
Net unrecognized compensation cost \| $	$ 2,120,646
Weighted average period for recognition of net unrecognized compensation cost	2 years 6 months

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY (Details)	3 Months Ended
	Mar. 31, 2022 USD ($) Group Segment	Mar. 31, 2021 USD ($)	Dec. 31, 2021 USD ($)
GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract]
Number of groups of similar products \| Group	1
Number of operating segments \| Segment	1
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	$ 18,816,611	$ 8,724,359
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	8,414,313		$ 8,556,773
Net Product Revenue [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	18,527,456	4,024,662
Africa [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	767,352	1,344,858
Africa [Member] \| Net Product Revenue [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	767,352	1,344,858
Asia [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	15,558	216,954
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	85,351		86,041
Asia [Member] \| Net Product Revenue [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	15,558	216,954
Europe & Middle East [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	723,745	2,600,274
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	101,231		113,883
Europe & Middle East [Member] \| Net Product Revenue [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	717,908	1,493,734
Latin America [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	12,557,390	258,019
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	58,685		36,224
Latin America [Member] \| Net Product Revenue [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	12,545,054	258,019
United States [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	4,752,566	4,304,254
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	8,169,046		$ 8,320,625
United States [Member] \| Net Product Revenue [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	$ 4,481,584	$ 711,097

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Details) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract]
Accounts payable - suppliers	$ 5,622,558	$ 7,745,592
Accrued commissions and royalties	1,510,865	1,359,691
Accrued payroll	494,653	494,258
Accrued vacation	657,008	421,416
Accrued bonuses	544,567	1,378,706
Accrued professional fees	893,745	522,935
Accrued expenses - other	819,455	1,205,395
TOTAL	$ 10,542,851	$ 13,127,993

GOODWILL AND INTANGIBLE ASSETS (Details)	3 Months Ended
GOODWILL AND INTANGIBLE ASSETS (Details)	Mar. 31, 2022 USD ($) Segment Unit
Goodwill [Roll Forward]
Goodwill, Beginning balance	$ 3,022,787
Impairment	(3,033,565)
Changes in foreign currency exchange rate	10,778
Goodwill, Ending balance	$ 0
Number of operating segment \| Segment	1
Number of reporting unit \| Unit	1