0001140361-21-027453 | 10-Q | XBRL Viewer

Document and Entity Information - shares	6 Months Ended
Document and Entity Information - shares	Jun. 30, 2021	Jul. 31, 2021
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Period End Date	Jun. 30, 2021
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	Q2
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
Title of 12(b) Security	Common Stock, $0.01 par value
Trading Symbol	CEMI
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		28,622,803

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)	Jun. 30, 2021	Dec. 31, 2020
CURRENT ASSETS:
Cash and cash equivalents	$ 5,564,349	$ 23,066,301
Accounts receivable, net of allowance for doubtful accounts of $193,535 and $296,793 at June 30, 2021 and December 31, 2020, respectively	2,977,082	3,377,387
Inventories, net	15,720,292	12,516,402
Prepaid expenses and other current assets	1,064,508	778,683
TOTAL CURRENT ASSETS	25,326,231	39,738,773
FIXED ASSETS:
Property, plant and equipment, net	9,149,460	8,688,403
Finance lease right-of-use asset, net	225,947	233,134
OTHER ASSETS:
Operating lease right-of-use asset, net	6,274,945	6,112,632
Intangible assets, net	2,329,859	3,645,986
Goodwill	5,899,531	5,963,744
Deposits and other assets	370,644	509,342
TOTAL ASSETS	49,576,617	64,892,014
CURRENT LIABILITIES:
Accounts payable and accrued liabilities	8,091,368	10,042,790
Deferred revenue	404,486	1,606,997
Operating lease liabilities	867,154	642,460
Finance lease liabilities	65,435	58,877
TOTAL CURRENT LIABILITIES	9,428,443	12,351,124
OTHER LIABILITIES:
Long-term operating lease liabilities	6,392,531	6,327,143
Long-term finance lease liabilities	174,466	185,239
Long-term debt, net	18,477,924	18,182,158
Deferred tax liability	0	69,941
TOTAL LIABILITIES	34,473,364	37,115,605
COMMITMENTS AND CONTINGENCIES (Note 6)
STOCKHOLDERS' EQUITY:
Preferred stock - 10,000,000 shares authorized; none issued and outstanding	0	0
Common stock - $0.01 par value; 100,000,000 shares authorized; 20,337,372 shares and 20,223,498 shares issued at June 30, 2021 and December 31, 2020, respectively	203,374	202,235
Additional paid-in capital	126,006,387	124,961,514
Accumulated deficit	(110,670,879)	(97,106,331)
Treasury Stock, 41,141 shares at cost, at June 30, 2021 and December 31, 2020	(190,093)	(190,093)
Accumulated other comprehensive loss	(245,536)	(90,916)
TOTAL STOCKHOLDERS' EQUITY	15,103,253	27,776,409
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 49,576,617	$ 64,892,014

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)	Jun. 30, 2021	Dec. 31, 2020
CURRENT ASSETS:
Accounts receivable, allowance for doubtful accounts	$ 193,535	$ 296,793
STOCKHOLDERS' EQUITY:
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized (in shares)	100,000,000	100,000,000
Common stock, shares issued (in shares)	20,337,372	20,223,498
Treasury stock, shares (in shares)	41,141	41,141

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
REVENUES:
TOTAL REVENUES	$ 6,462,110	$ 5,111,172	$ 15,186,469	$ 11,970,755
COSTS AND EXPENSES:
Cost of product sales	4,039,696	5,670,737	7,588,137	10,045,179
Research and development expenses	2,796,981	1,922,306	5,660,319	3,881,159
Selling, general and administrative expenses	6,001,353	4,397,593	12,086,422	8,554,234
Asset impairment, restructuring, severance and related costs	1,961,156	387,540	2,044,243	1,110,658
Acquisition costs	0	0	0	63,497
TOTAL COSTS AND EXPENSES	14,799,186	12,378,176	27,379,121	23,654,727
LOSS FROM OPERATIONS	(8,337,076)	(7,267,004)	(12,192,652)	(11,683,972)
OTHER EXPENSE:
Interest expense, net	(727,374)	(712,052)	(1,439,851)	(1,374,192)
LOSS BEFORE INCOME TAXES	(9,064,450)	(7,979,056)	(13,632,503)	(13,058,164)
Income tax benefit	65	135,259	67,955	214,818
NET LOSS	$ (9,064,385)	$ (7,843,797)	$ (13,564,548)	$ (12,843,346)
Basic loss per share (in dollars per share)	$ (0.45)	$ (0.42)	$ (0.67)	$ (0.71)
Diluted loss per share (in dollars per share)	$ (0.45)	$ (0.42)	$ (0.67)	$ (0.71)
Weighted average number of shares outstanding, basic (in shares)	20,219,617	18,868,144	20,191,657	18,032,723
Weighted average number of shares outstanding, diluted (in shares)	20,219,617	18,868,144	20,191,657	18,032,723
Net Product Sales [Member]
REVENUES:
TOTAL REVENUES	$ 3,931,383	$ 3,791,574	$ 7,956,045	$ 9,508,166
R&D Revenue [Member]
REVENUES:
TOTAL REVENUES	727	1,193,973	1,107,366	2,101,660
Government Grant Income [Member]
REVENUES:
TOTAL REVENUES	2,280,000	0	5,630,000	0
License and Royalty Revenue [Member]
REVENUES:
TOTAL REVENUES	$ 250,000	$ 125,625	$ 493,058	$ 360,929

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS [Abstract]
Net loss	$ (9,064,385)	$ (7,843,797)	$ (13,564,548)	$ (12,843,346)
Other comprehensive loss:
Foreign currency translation adjustments	301,102	(175,447)	(154,620)	(1,038,741)
Comprehensive loss	$ (8,763,283)	$ (8,019,244)	$ (13,719,168)	$ (13,882,087)

- 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]	AOCI [Member]	Total
Balance at Dec. 31, 2019	$ 177,335	$ 95,433,077	$ 0	$ (71,585,003)	$ 9,844	$ 24,035,253
Balance (in shares) at Dec. 31, 2019	17,733,617		0
Common Stock:
Restricted stock issued	$ 343	117,956	$ 0	0	0	118,299
Restricted stock issued (in shares)	34,249		0
Restricted stock compensation, net	$ (4,406)	(292,495)	$ 0	0	0	(296,901)
Restricted stock compensation, net (in shares)	(440,631)		0
Shares tendered for withholding taxes	$ 0	145,056	$ (145,056)	0	0	0
Shares tendered for withholding taxes (in shares)	0		(31,486)
Options:
Stock option compensation	$ 0	139,449	$ 0	0	0	139,449
Comprehensive loss	0	0	0	0	(863,294)	(863,294)
Net loss	0	0	0	(4,999,549)	0	(4,999,549)
Balance at Mar. 31, 2020	$ 173,272	95,543,043	$ (145,056)	(76,584,552)	(853,450)	18,133,257
Balance (in shares) at Mar. 31, 2020	17,327,235		(31,486)
Balance at Dec. 31, 2019	$ 177,335	95,433,077	$ 0	(71,585,003)	9,844	24,035,253
Balance (in shares) at Dec. 31, 2019	17,733,617		0
Options:
Comprehensive loss						(1,038,741)
Net loss						(12,843,346)
Balance at Jun. 30, 2020	$ 201,948	124,143,171	$ (150,919)	(84,428,349)	(1,028,897)	38,736,954
Balance (in shares) at Jun. 30, 2020	20,194,832		(33,290)
Balance at Mar. 31, 2020	$ 173,272	95,543,043	$ (145,056)	(76,584,552)	(853,450)	18,133,257
Balance (in shares) at Mar. 31, 2020	17,327,235		(31,486)
Common Stock:
Issuance of stock, net	$ 26,196	28,410,545				28,436,741
Issuance of stock, net (in shares)	2,619,593
Restricted stock issued	$ 189	(189)				0
Restricted stock issued (in shares)	18,858
Restricted stock compensation, net	$ (296)	262,405				262,109
Restricted stock compensation, net (in shares)	(29,543)
Shares tendered for withholding taxes	$ 0	(192,161)	$ (5,863)			(198,024)
Shares tendered for withholding taxes (in shares)	0		(1,804)
Options:
Exercised	$ 55	(55)				0
Exercised (in shares)	5,528
Stock option compensation	$ 0	122,115				122,115
Warrants exercised	$ 2,532	(2,532)				0
Warrants exercised (in shares)	253,161
Comprehensive loss	$ 0	0	$ 0		(175,447)	(175,447)
Net loss	0	0	0	(7,843,797)	0	(7,843,797)
Balance at Jun. 30, 2020	$ 201,948	124,143,171	$ (150,919)	(84,428,349)	(1,028,897)	38,736,954
Balance (in shares) at Jun. 30, 2020	20,194,832		(33,290)
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 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, 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)
Options:
Comprehensive loss						(154,620)
Net loss						(13,564,548)
Balance at Jun. 30, 2021	$ 203,374	126,006,387	$ (190,093)	(110,670,879)	(245,536)	15,103,253
Balance (in shares) at Jun. 30, 2021	20,337,372		(41,141)
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)
Common Stock:
Restricted stock issued	$ 517	(517)	$ 0	0	0	0
Restricted stock issued (in shares)	51,677		0
Restricted stock compensation, net	$ 0	288,053	$ 0	0	0	288,053
Restricted stock compensation, net (in shares)	0		0
Shares tendered for withholding taxes	$ 0	(4,454)	$ 0	0	0	(4,454)
Shares tendered for withholding taxes (in shares)	0		0
Options:
Stock option compensation	$ 0	297,791	$ 0	0	0	297,791
Comprehensive loss	0	0	0	0	301,102	301,102
Net loss	0	0	0	(9,064,385)	0	(9,064,385)
Balance at Jun. 30, 2021	$ 203,374	$ 126,006,387	$ (190,093)	$ (110,670,879)	$ (245,536)	$ 15,103,253
Balance (in shares) at Jun. 30, 2021	20,337,372		(41,141)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Cash received from customers and grants	$ 14,493,073	$ 16,993,648
Cash paid to suppliers and employees	(28,559,938)	(22,751,210)
Cash paid for operating leases	(696,188)	(457,277)
Cash paid for finance leases	(10,312)	(9,367)
Interest and taxes, net	(1,135,295)	(1,106,778)
Net cash used in operating activities	(15,908,660)	(7,330,984)
CASH FLOWS FROM INVESTING ACTIVITIES:
Patent application costs	(28,023)	(98,186)
Acquisition of and deposits on fixed assets	(1,270,989)	(2,351,160)
Net cash used in investing activities	(1,299,012)	(2,449,346)
CASH FLOWS FROM FINANCING ACTIVITIES:
Issuance of stock, net	0	28,436,741
Stimulus package loan	0	2,978,315
Stimulus package loan payment	0	(2,978,315)
Payments on note payable	0	(104,542)
Payments of tax withholding on stock award	(119,513)	(343,080)
Payments on finance lease	(29,820)	(23,578)
Net cash (used in) provided by financing activities	(149,333)	27,965,541
Effect of exchange rate changes on cash	(144,947)	(29,095)
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS	(17,501,952)	18,156,116
Cash and cash equivalents - beginning of the period	23,066,301	18,271,352
Cash and cash equivalents - end of the period	5,564,349	36,427,468
RECONCILIATION OF NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES:
Net loss	(13,564,548)	(12,843,346)
Adjustments:
Depreciation and amortization	1,390,897	1,441,823
Share based compensation	1,165,632	347,141
Non-cash inventory adjustments	863,612	0
Benefit from deferred tax liability	(69,941)	(216,000)
Impairment of long-lived assets	1,273,945	0
Recovery of (provision of) doubtful accounts	(103,258)	94,262
Changes in assets and liabilities:
Accounts receivable	503,563	1,050,738
Inventories	(4,067,502)	(4,533,511)
Prepaid expenses and other current assets	(285,825)	(49,894)
Deposits and other assets	138,698	113,655
Accounts payable and accrued liabilities	(1,951,422)	3,291,993
Deferred revenue	(1,202,511)	3,972,155
Net cash used in operating activities	(15,908,660)	(7,330,984)
Supplemental disclosures for non-cash investing and financing activities:
Deposits on manufacturing equipment transferred to fixed assets	$ 0	$ 472,651

DESCRIPTION OF BUSINESS	6 Months Ended
DESCRIPTION OF BUSINESS	Jun. 30, 2021
DESCRIPTION OF BUSINESS [Abstract]
DESCRIPTION OF BUSINESS	NOTE 1 — DESCRIPTION OF BUSINESS: Chembio Diagnostics, Inc. (“Chembio”) and its subsidiaries (collectively with Chembio, the “Company”) develop and commercialize point-of-care rapid tests used for the detection and diagnosis of infectious diseases, including COVID-19, sexually transmitted disease, and fever and tropical disease. Coupled with the Company’s extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease. Chembio’s products are sold globally, directly and through distributors, to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers under the Company’s DPP, STAT-PAK, SURE CHECK and STAT-VIEW registered trademarks or under the private labels of the Company’s marketing partners. The Company’s future working capital needs will depend on many factors, including the rate of its business and revenue growth, the availability and cost of human, material and other resources required to build and deliver products in accordance with its existing or future product orders, the timing of its continuing automation of U.S. manufacturing, and the timing of its investment in research and development as well as sales and marketing. If the Company is unable to increase its revenues and manage its expenses in accordance with its operating plan, it may need to reduce the level or slow the timing of the growth plans contemplated by its operating plan, which would likely curtail or delay the growth in its business contemplated by its operating plan and could impair or defer its ability to achieve profitability and generate cash flow, or to seek to raise additional funds through debt or equity financings, strategic relationships, or other arrangements (see Note 2(a)— Basis of Presentation and Note 12—Subsequent Events). All DPP tests are developed and manufactured in the United States and are the subject of a range of domestic and global patents and patents pending.

SIGNIFICANT ACCOUNTING POLICIES

6 Months Ended

Jun. 30, 2021

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. 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, 2020, as filed with the SEC.

Going Concern Considerations

Revenues during the three months ended June 30, 2021 did not meet the Company’s expectations, and the shortfall in revenues was a principal cause of the Company’s limited cash and cash-equivalents position as of June 30, 2021. The decrease in cash and cash-equivalents over the first two quarters of 2021 reflected market, clinical trial and regulatory complications the Company faced in seeking to develop and commercialize a portfolio of COVID-19 test systems during the continuing, but evolving, uncertainty of the COVID‑19 pandemic. The decrease in cash and cash-equivalents also resulted in part from significant continuing expenses incurred in connection with pending legal matters (see “Note 6(f) – Commitments, Contingencies, and Concentrations: Litigation”); delayed achievement of milestones associated with government grant income; investments in inventory; and, the continuing automation of U.S. manufacturing.

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 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 entity’s ability to continue as a going concern.

Following June 30, 2021, as discussed in Note 16 – Subsequent Events, the Company undertook measures to increase its total revenues and improve its liquidity position:

•	The Company received significant purchase orders from two customers. The Company had pursued the purchase orders for an extended period of time, but did not receive them until July 2021 as follows:

•

On July 20, 2021, the Company received a $28.3 million purchase order from Bio-Manguinhos for the purchase of DPP SARS-CoV-2 Antigen tests for delivery during 2021 to support the urgent needs of Brazil’s Ministry of Health in addressing the COVID-19 pandemic. Bio-Manguinhos, a subsidiary of the Oswaldo Cruz Foundation, is responsible for the development and production of vaccines, diagnostics and biopharmaceuticals, primarily to meet demands of Brazil’s national public health system.

•	On July 22, 2021, the Company received a $4 million purchase order from the Partnership for Supply Chain Management, supported by The Global Fund, for the purchase of HIV 1/2 STAT-PAK Assays for shipment to Ethiopia into early 2022.

•

The Company raised net proceeds of approximately $34.7 million from the issuance and sale of 8,323,242 shares of common stock pursuant to an At the Market Offering Agreement (the “ATM Agreement”) with Craig‑Hallum Capital Group LLC (“Craig-Hallum”), pursuant to which Chembio may sell from time to time, at its option, up to an aggregate of $60,000,000 of shares of common stock through Craig‑Hallum, as sales agent.

These measures and other plans and initiatives of the Company were 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 issued. Such plans and initiatives are dependent, however, on factors that are beyond the Company’s control or that may not be available on terms acceptable to the Company, or at all. The Company considered how the uncertainties around the delivery of the full number of tests covered by the two purchase orders received in July 2021 and other customer orders may be affected by limitations of the Company’s supply chain, staffing and liquidity, uncertainties regarding the achievement of milestones and related recognition of revenue under government grants, and other matters outside the Company’s control. The Company further considered how such uncertainties could impact its ability to meet the obligations specified in the Credit Agreement (as defined in Note 7– Long-Term Debt) over the next twelve months, which include attaining Minimum Total Revenue (as defined) for the twelve-months preceding each quarter end. For the next year, the Minimum Total Revenue requirements range from approximately $37.4 million for the twelve months ending September 30, 2021 to approximately $43.8 million for the twelve months ending June 30, 2022 (see Note 7 – Long-Term Debt). 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, Chembio 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. Chembio’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 by the Company for its operations, could have a material adverse effect on the Company’s business, prospects, results of operations, liquidity and financial condition. Accordingly, management determined the Company could not be certain that its plans and initiatives would be effectively implemented within one year after the date the accompanying unaudited condensed consolidated financial statements are issued.

Without giving effect to the prospect of raising additional capital pursuant to the ATM Agreement, 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 rent, 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 the accompanying unaudited condensed consolidated financial statements are 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 six months ended June 30, 2021, 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, 2020, 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 $0.5 million and $14.8 million as of June 30, 2021 and December 31, 2020, 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 $18.5 million) and $20.0 million (carrying value of $18.2 million) as of June 30, 2021 and December 31, 2020, 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 with original maturities of three months or less at date of purchase, and include restricted cash of $0.4 million and $1.0 million as of June 30, 2021 and December 31, 2020, respectively.

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

(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 and six months ended June 30, 2021 and 2020 reflects the potential dilution from the exercise or conversion of other securities into common stock, if dilutive.

There were 1,867,045 and 1,034,124 options outstanding as of June 30, 2021 and 2020, respectively, that were not included in the calculation of diluted per common share equivalents for the three and six months ended June 30, 2021 and 2020, respectively, because the effect would have been anti-dilutive.

There were 803,062 and 619,385 restricted stock outstanding, each corresponding to one share of common stock, as of June 30, 2021 and 2020, respectively, that were not included in the calculation of diluted per common share equivalents for the three and six months ended June 30, 2021 and 2020, 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 and six months ended June 30, 2021 was (1.11)% and 0.51%, respectively, compared to the effective tax rate of 1.7% for both the three and six months ended June 30, 2020. The Company’s effective tax rates for both periods were affected primarily by a full valuation allowance on domestic net deferred tax assets and a benefit from foreign net operating losses.

(g)

Recently Issued Accounting Standards Affecting the Company:

Recently Adopted

ASU 2020-10, Codification Improvements

In October 2020, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2020-10, which clarifies various topics in the FASB’s Accounting Standards Codification (the “ASC”), including the addition of existing disclosure requirements to the relevant disclosure sections. This update improves consistency by amending the ASC to include all disclosure guidance in the appropriate disclosure sections and clarifies application of various provisions in the ASC by amending and adding new headings, cross referencing to other guidance, and refining or correcting terminology. The Company adopted the standard effective December 31, 2020 and has determined that the adoption did not have a material impact on the Company’s consolidated financial statements.

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

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

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

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

ASU 2021-01—Reference Rate Reform (Topic 848)

In January 2021, the FASB issued ASU 2021-01, which refines the scope of ASC Topic 848 and clarifies some of its guidance as part of the monitoring of global reference rate reform activities by a board of directors. The ASU permits entities to elect certain optional expedients and exceptions when accounting for derivative contracts and certain hedging relationships affected by changes in the interest rates used for discounting cash flows, for computing variation margin settlements, and for calculating price alignment interest (PAI3) in connection with reference rate reform activities under way in global financial markets (the “discounting transition”). ASU 2021-01 expands the scope of ASC Topic 848 to include all affected derivatives and give market participants the ability to apply certain aspects of the contract modification and hedge accounting expedients to derivative contracts affected by the discounting transition. In addition, ASU 2021-01 adds implementation guidance (codified in ASC 848-10-55-1) to clarify which optional expedients in ASC Topic 848 may be applied to derivative instruments that do not reference LIBOR or a reference rate that is expected to be discontinued, but that are being modified as a result of the discounting transition. The Company adopted the standard effective January 1, 2021 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

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

ASU 2021-04 - Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options

On May 3, 2021, the FASB issued ASU 2021-04, which is the final guidance that requires issuers to account for modifications or exchanges of freestanding equity-classified written call options (e.g., warrants) that remain equity classified after the modification or exchange based on the economic substance of the modification or exchange. Under the guidance, an issuer determines the accounting for the modification or exchange based on whether the transaction was done to issue equity, to issue or modify debt, or for other reasons. The guidance is applied prospectively and is effective for all entities for fiscal years beginning after 15 December 2021, and interim periods within those fiscal years. Early adoption is permitted. The Company continues to assess the potential impact of the standard.

REVENUE

6 Months Ended

Jun. 30, 2021

REVENUE [Abstract]

REVENUE

NOTE 3 — REVENUE:

Disaggregation of Revenue

The following table disaggregates Total Revenues:

	For the three months ended
	June 30, 2021						June 30, 2020
	Exchange Transactions		Non-Exchange Transactions		Total		Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	3,931,383	$	-	$	3,931,383	$	3,791,574	$	-	$	3,791,574
R&D revenue		727		-		727		1,193,973		-		1,193,973
Government grant income		-		2,280,000		2,280,000		-		-		-
License and royalty revenue		250,000		-		250,000		125,625		-		125,625
	$	4,182,110	$	2,280,000	$	6,462,110	$	5,111,172	$	-	$	5,111,172

	For the six months ended
	June 30, 2021						June 30, 2020
	Exchange Transactions		Non-Exchange Transactions		Total		Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	7,956,045	$	-	$	7,956,045	$	9,508,166	$	-	$	9,508,166
R&D revenue		1,107,366		-		1,107,366		2,101,660		-		2,101,660
Government grant income		-		5,630,000		5,630,000		-		-		-
License and royalty revenue		493,058		-		493,058		360,929		-		360,929
	$	9,556,469	$	5,630,000	$	15,186,469	$	11,970,755	$	-	$	11,970,755

Exchange transactions are recognized in accordance with ASC Topic 606, Revenue from Contracts with Customers, while non-exchange transactions are recognized in accordance with ASU 2018-08, Not-For-Profit Entities (Topic 958): Clarifying the Scope and Accounting Guidance for Contributions Received and Contributions Made.

The following table disaggregates Total Revenues by geographic location:

	For the three months ended				For the six months ended
	June 30, 2021		June 30, 2020		June 30, 2021		June 30, 2020
Africa	$	1,466,356	$	552,570	$	2,811,214	$	1,436,085
Asia		53,592		119,319		270,547		482,607
Europe & Middle East		806,209		1,635,017		3,406,485		3,811,172
Latin America		487,517		780,567		745,536		2,896,963
United States		3,648,436		2,023,699		7,952,687		3,343,928
	$	6,462,110	$	5,111,172	$	15,186,469	$	11,970,755

Contract Liabilities

Deferred revenue relates to payments received in advance of performance under the contract. Deferred revenue is recognized as revenue as (or when) the Company performs under the contract. At March 31, 2021, the Company reported $0.4 million in deferred revenue, none of which was earned and recognized during the three months ended June 30, 2021. At June 30, 2021, the Company reported $0.4 million in deferred revenue that is expected to be recognized in the three months ending September 30, 2021.

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

INVENTORY

6 Months Ended

Jun. 30, 2021

INVENTORY [Abstract]

INVENTORY

NOTE 4 — INVENTORY:

Inventories are presented net of reserves and consisted of the following:

	June 30, 2021		December 31, 2020
Raw materials	$	6,611,511	$	5,955,215
Work in process		6,921,768		2,549,516
Finished goods		2,187,013		4,011,671
	$	15,720,292	$	12,516,402

During the three months ended June 30, 2021 the Company recognized a $0.9 million charge related to the write-down of inventory for products that were not salable, based on its periodic review of the current status and future benefits of inventory.

STOCKHOLDERS' EQUITY

6 Months Ended

Jun. 30, 2021

STOCKHOLDERS' EQUITY [Abstract]

STOCKHOLDERS' EQUITY

NOTE 5 — STOCKHOLDERS’ EQUITY:

(a)

Common Stock

During the three and six months ending June 30, 2021 and 2020, there were no options exercised.

(b)

Preferred Stock

The Company has 10,000,000 shares of preferred stock authorized and none issued or 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

The Company has 41,141 shares of common stock held as treasury stock, which were acquired upon the vesting of restricted stock awards related to the tax withholding requirements paid on behalf of 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 the Company’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.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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-Topic 505
-SubTopic 10
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-Subparagraph (b)
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+ Details

COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS

6 Months Ended

Jun. 30, 2021

COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS [Abstract]

COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS

NOTE 6 – COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS:

(a)

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										For the six months ended										Accounts Receivable as of
	June 30, 2021					June 30, 2020					June 30, 2021					June 30, 2020					June 30, 2021		December. 31, 2020
	Sales		% of Sales			Sales		% of Sales			Sales		% of Sales			Sales		% of Sales
Customer 1	$	1,014,638		25.8	%	$	*		*		$	1,151,615		14.5	%	$	*		*		$	376,075	$	*
Customer 2		*		*			657,304		17.0	%		*		*			2,297,376		24.0	%		*		806,196

In the table above, an asterisk (*) indicates that sales did not exceed 10% for the period indicated.

There were no purchases the Company had from any vendor that totaled in excess of 10% of the Company’s total net purchases for the three or six months ending in June, 30 2021.

The Company currently buys materials that are purchased under intellectual property rights agreements and 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, either from the logistic and regulatory implications of changing suppliers or from product attributable changes to new components, any of which could result in a loss of sales and adversely affect operating results.

(b)

Governmental Regulation:

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

(c)

Employment Contracts:

The Company has multi-year contracts with two key employees. The contracts call for salaries presently aggregating $843,292 per year. The contracts are scheduled to expire on December 2021, and the Company’s minimum salary commitments under the agreements for the last six months of 2021 total $421,646. Under one of those contracts, however, the term of the contract will extend automatically until December 31, 2022 if neither party provides, by October 1, 2021, notice electing to have the contract terminate on December 31, 2021. If no such notice is timely delivered, the Company will have a minimum salary commitment under the contract of $460,000 for the year ending December 31, 2022.

(d)

Benefit Plan:

The Company has a 401(k) plan established for its 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 $29,933 and $35,456 for the three months ended June 30, 2021 and 2020, respectively. Matching contribution expenses totaled $65,388 and $49,407 for the six months ended June 30, 2021 and 2020, respectively.

(e)

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 that renewal period is included in the lease term and the related payments are reflected in the right-of-use asset and lease liability.

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

Effective June 2021, the Company permanently discontinued its operations in Malaysia. Impairment charges for the Malaysian facility right-of-use asset recorded during the three and six months ended June 30, 2021 was $0.1 million.

The components of lease expense were as follows:

	Three months ended June 30,				Six months ended June 30,
	2021		2020		2021		2020
Operating lease expense	$	402,329	$	388,951	$	810,795	$	852,808

Finance lease cost
Amortization of right-of-use assets	$	17,038	$	14,687	$	32,796	$	27,085
Interest on lease liabilities		5,368		5,156		10,312		9,367
Total finance lease expense	$	22,406	$	19,843	$	43,108	$	36,452

Supplemental cash flow information related to leases was as follows:

	Three months ended June 30,				Six months ended June 30,
	2021		2020		2021		2020
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows for operating leases	$	348,317	$	292,058	$	696,188	$	457,277
Operating cash flows for finance leases		5,368		5,156		10,312		9,367
Financing cash flows for finance leases		15,538		12,666		29,820		23,578
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	694,668	$	-	$	694,668	$	-
Finance leases		25,609		47,499		25,609		75,852

Supplemental balance sheet information related to leases was as follows:

	June 30, 2021			June 30, 2020
Finance Leases
Finance lease right-of-use asset	$	340,762		$	309,574
Accumulated depreciation		(114,815	)		(50,690	)
Finance lease right-of-use asset, net	$	225,947		$	258,884

Weighted-Average Remaining Lease Term
Operating leases	7.9 Years			9.0 Years
Finance leases	3.4 Years			4.0 Years

Weighted-Average Discount Rate
Operating leases		8.73	%		8.62	%
Finance leases		8.43	%		9.73	%

Maturities of lease liabilities were as follows:

	June 30, 2021				June 30, 2020
	Operating Leases		Finance Leases		Operating Leases		Finance Leases
2020 and 2021	$	708,344	$	41,812	$	682,667	$	37,720
2022		1,447,249		83,624		1,209,787		75,440
2023		1,221,017		83,624		1,057,757		75,440
2024		1,018,875		55,856		1,026,272		75,440
2025		1,049,442		12,471		1,018,875		47,672
Thereafter		4,724,446		1,680		5,773,887		4,775
Total lease payments	$	10,169,373	$	279,067	$	10,769,245	$	316,487
Less: imputed interest		2,909,688		39,166		3,427,535		50,366
Total	$	7,259,685	$	239,901	$	7,341,710	$	266,121

(f)

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 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 purports to allege claims based on assertedly false and misleading statements and omissions concerning the performance of the DPP COVID-19 IgM/IgG System, as well as an asserted failure to timely disclose that the emergency use authorization that had been granted by the FDA with respect to the DPP COVID-19 IgM/IgG System “was — or was at an increased risk of — being revoked.” The CAC names as defendants Chembio, Richard L. Eberly, Gail S. Page, Neil A. Goldman, Javan Esfandiari, Katherine L. Davis, Mary Lake Polan, John Potthoff and the underwriters for the May 2020 Offering, Robert W. Baird & Co., Inc. and Dougherty & Company LLC.

The CAC purports to assert five counts under the Securities Act and the Exchange Act. Counts I through III are brought under the Securities Act, allegedly on behalf of a purported class consisting of all persons who purchased Chembio common stock directly in or traceable to the 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 purports to allege a claim for violation of Section 11 of the Securities Act against all defendants other than Messrs. Eberly and Esfandiari. Count II purports to allege a claim for violation of Section 12 of the Securities Act against all defendants other than Messrs. Eberly and Esfandiari. Count III purports to allege a claim under Section 15 of the Securities Act against Ms. Davis, Dr. Polan, Dr. Potthoff, Ms. Page and Mr. Goldman.

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

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

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

On March 5, 2021, the Court entered an order in which it advised the parties 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 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 defendants’ motions remain pending before the Court. At this stage in the litigation, the Company is not able to predict the probability of a favorable or unfavorable outcome.

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 in the litigation, the Company is not able to predict the probability of a favorable or unfavorable outcome.

Commercial Litigation

Chembio’s wholly owned subsidiary Chembio Diagnostic Systems Inc. (“Systems”) and BioSure (UK) Ltd. (“BioSure”) entered into the BioSure Sure Check HIV 1/2 Assay OTC Agreement dated April 2, 2014 and as subsequently amended (as so amended, the “Distribution Agreement”). Pursuant to the Distribution Agreement, BioSure acquired the right to sell bundled products in the United Kingdom containing the Company’s Sure Check HIV 1/2 pouched tests. The Distribution Agreement terminated on April 1, 2019. On September 16, 2019, Systems initiated arbitration in the International Arbitration Tribunal of the International Centre for Dispute Resolution in New York, New York. Systems alleges that BioSure (a) breached various provisions of the Distribution Agreement, (b) misappropriated trade secrets of Systems, (c) engaged in deceptive business acts and practices, and (d) breached the implied covenant of good faith and fair dealing. On November 23, 2020, BioSure requested leave to file a counterclaim seeking recession of the Distribution Agreement based on alleged fraudulent concealment by Systems. Systems opposed BioSure’s request for leave to file the counterclaim on procedural and substantive grounds, and on December 11, 2020 the Tribunal denied the request for leave to file the counterclaim. The Tribunal’s denial was without prejudice to BioSure’s ability to assert its claim in a separate proceeding. BioSure continues to deny the relief sought and alleges certain statements Systems made to third parties about the Distribution Agreement were in bad faith and are a defense to Systems’ claims. BioSure also asserts that certain alleged misrepresentations entitle BioSure to “set off” any award Systems might receive from the Tribunal. The parties have completed discovery and submitted their first pre-hearing submissions. Systems intends to vigorously pursue its claims in the arbitration. The final merits hearing took place from April 20, 2021 to April 23, 2021. At this stage in the litigation, the Company is not able to predict the probability of a favorable or unfavorable outcome.

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 assertedly 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 recently served initial disclosures, 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. At this stage in 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	6 Months Ended
LONG-TERM DEBT	Jun. 30, 2021
LONG-TERM DEBT [Abstract]
LONG-TERM DEBT	NOTE 7 — LONG-TERM DEBT: On September 3, 2019, Chembio and certain of its subsidiaries, as guarantors, 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 the Company’s existing indebtedness and (iii) to pay fees, costs and expenses incurred in connection with the Credit Agreement, including the Lender’s closing cost amount of $550,000, which was netted from the proceeds, and a financing fee of $600,000 (3.0% of gross proceeds) payable to Craig-Hallum, 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 June 30, 2021 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. Chembio may prepay outstanding principal from time to time, subject to payment of a premium on the prepaid principal amount equal to 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. The Credit Agreement contains financial covenants requiring that Chembio (i) maintain aggregate unrestricted cash of not less than $3,000,000 at all times and (ii) achieve specified minimum total revenue requirements for twelve months preceding each quarter end. The minimum total revenue amounts, which range from $32.0 million to $50.1 million, were developed for purposes of the Credit Agreement and do not reflect the internal estimates and plans used by Chembio’s management and the Board to understand and evaluate the Company’s operating performance, to establish budgets, and to establish operational goals for managing the Company’s business. As of June 30, 2021, the loan balance, net of unamortized discounts and debt issuance costs, was $18.5 million, and Chembio was in compliance with its loan covenants. See Note 2(a)—Basis of Presentation.

EQUITY INCENTIVE PLAN

6 Months Ended

Jun. 30, 2021

EQUITY INCENTIVE PLAN [Abstract]

EQUITY INCENTIVE PLAN

NOTE 8 — EQUITY INCENTIVE PLAN:

(a)

Equity Plans:

Effective June 3, 2008, Chembio’s stockholders voted to approve the 2008 Stock Incentive Plan (the “2008 Plan”), with 625,000 shares of common stock available to be issued. At the Annual Stockholder Meeting on September 22, 2011 Chembio’s stockholders voted to approve an increase to the shares of common stock issuable under the 2008 Plan by 125,000 to 750,000. Under the terms of the 2008 Plan, which expired during 2018, the Board or its Compensation Committee had the discretion to select the persons to whom awards were to be granted. Awards could be stock options, restricted stock and/or restricted stock units (collectively, “Equity Award Units”). The awards became vested at such times and under such conditions as determined by the Board or its Compensation Committee. Cumulatively through June 30, 2021, there were 714,000 options expired, forfeited or exercised, and at June 30, 2021, 36,000 options were outstanding and no Equity Award Units were available to be issued under the 2008 Plan.

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 June 30, 2021, there were 519,782 Equity Award Units expired, forfeited or exercised. At June 30, 2021, 259,157 Equity Award Units were outstanding, 21,061 shares were rolled over into the 2019 Plan, and 0 Equity Award Units remained 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 unit, or other stock-based award 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 June 30, 2021, 440,310 2019 Equity Units have been cancelled or forfeited. At June 30, 2021, 2,219,224 2019 Equity Units were outstanding, and 2,658,522 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 June 30				For the six months ended June 30
	2021		2020		2021		2020
Cost of product sales	$	43,368	$	-	$	72,136	$	6,300
Research and development expenses		139,469		90,924		223,704		154,737
Selling, general and administrative expenses		403,007		293,301		869,792		610,089
Severance and related costs		-		-		-		(423,985	)
	$	585,844	$	384,225	$	1,165,632	$	347,141

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

	For the three months ended June 30, 2021			For the six months ended June 30, 2021
Expected term (in years)		6.0			5.0
Expected volatility		76.42	%		78.23	%
Expected dividend yield		1.01	%		0.81	%
Risk-free interest rate		2.03	%		2.93	%

The following table provides stock option activity for the six months ended June 30, 2021:

Stock Options	Number of Shares	Weighted Average Exercise Price per Share		Weighted Average Remaining Contract Term	Aggregate Intrinsic Value
Outstanding at December 31, 2020	974,778	$	4.12	2.87 years	$	1,520,910

Granted	925,949		4.73			-
Exercised	-		-			-
Forfeited	8,682		5.89			-
Expired	25,000		5.64
Outstanding at June 30, 2021	1,867,045	$	4.40	7.08 years	$	388,182
Exercisable at June 30, 2021	526,210	$	4.79	4.28 years	$	173,621

The following table summarizes information about stock options outstanding at June 30, 2021:

	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		636,364		5.71	$	2.36	$	388,182		284,624	$	2.36	$	173,621
2.8 to 4.59999		27,502		9.92		3.11		-		-		-		-
4.6 to 6.39999		946,514		9.16		4.81		-		14,961		5.49		-
6.4 to 8.19999		209,790		2.62		7.30		-		198,500		7.27		-
8.2 to 12		46,875		2.10		11.45		-		28,125		11.45		-
Total		1,867,045		7.08	$	4.40	$	388,182		526,210	$	4.79	$	173,621

As of June 30, 2021, there was $2,907,843 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 2.89 years. The total fair value of options vested during the six months ended June 30, 2021 and 2020 were $335,579 and $112,311, respectively.

The following table summarizes information about restricted stock, restricted stock units and performance stock units outstanding as of June 30, 2021:

	Number of Shares & Units		Weighted Average Grant Date Fair Value
Outstanding at December 31, 2020		603,531	$	3.08

Granted		334,564		4.66
Vested		130,907		2.36
Forfeited		4,126		5.34
Outstanding at June 30, 2021		803,062	$	3.67

As of June 30, 2021, there was $2,155,021 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 2.51 years.

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY

6 Months Ended

Jun. 30, 2021

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 sales by geographic area were as follows:

	For the three months ended June 30,				For the six months ended June 30,
	2021		2020		2021		2020
Africa	$	1,466,356	$	552,570	$	2,811,215	$	1,436,085
Asia		53,593		119,319		270,547		482,607
Europe & Middle East		805,482		734,073		2,299,216		1,909,162
Latin America		487,517		780,567		745,536		2,896,963
United States		1,118,435		1,605,045		1,829,531		2,783,349
	$	3,931,383	$	3,791,574	$	7,956,045	$	9,508,166

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

	June 30, 2021		December 31, 2020
Asia	$	132,681	$	326,267
Europe & Middle East		130,185		147,692
Latin America		34,014		14,719
United States		8,852,580		8,199,725
	$	9,149,460	$	8,688,403

Effective June 2021, the Company permanently discontinued its operations in Malaysia. Impairment charges recorded for the Malaysian property, plant and equipment during the three months ended June 30, 2021 was $0.2 million.

- 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
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 31
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8924-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
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-Section 50
-Paragraph 34
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8981-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
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-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e9031-108599

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (f)
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8933-108599

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
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-Paragraph 32
-Subparagraph (e)
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8933-108599

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
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-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8933-108599

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

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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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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

6 Months Ended

Jun. 30, 2021

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:

	June 30, 2021		December 31, 2020
Accounts payable – suppliers	$	5,896,027	$	5,727,781
Accrued commissions and royalties		586,341		807,708
Accrued payroll		223,111		277,908
Accrued vacation		525,137		417,238
Accrued bonuses		234,000		1,193,985
Accrued severance		-		511,681
Accrued expenses – other		626,752		1,106,489
TOTAL	$	8,091,368	$	10,042,790

GOODWILL, LONG-LIVED ASSETS and INTANGIBLE ASSETS

6 Months Ended

Jun. 30, 2021

GOODWILL, LONG-LIVED ASSETS and INTANGIBLE ASSETS [Abstract]

GOODWILL AND INTANGIBLE ASSETS

NOTE 11 — GOODWILL, LONG-LIVED ASSETS and INTANGIBLE ASSETS:

The following table reflects changes in goodwill:

Beginning balance at December 31, 2020	$	5,963,744
Change in foreign currency exchange rate		(64,213	)
Balance at June 30, 2021	$	5,899,531

Intangible assets consisted of the following at:

			June 30, 2021						December 31, 2020
	Weighted Average Remaining Useful Life		Cost		Accumulated Amortization		Net Book Value		Cost		Accumulated Amortization		Net Book Value
Intellectual property		7	$	775,801	$	166,366	$	609,435	$	1,638,699	$	472,190	$	1,166,509
Developed technology		5		2,036,368		709,538		1,326,830		2,102,526		594,186		1,508,340
Customer contracts/relationships		6		539,461		145,867		393,594		1,323,424		423,093		900,331
Trade names		7		4,231		4,231		-		115,318		44,512		70,806
			$	3,355,861	$	1,026,002	$	2,329,859	$	5,179,967	$	1,533,981	$	3,645,986

Intellectual property, developed technology, customer contracts/relationships and trade names are amortized over 10, 7, 10 and 11 years, respectively. Amortization expense for the six months ended June 30, 2021 and 2020 was $264,608 and $287,253. Amortization expense, subject to changes in currency exchange rates, is expected to average $389,023 per year from 2021 through 2025, and total $384,745 for all of the years thereafter.

Effective June 2021, the Company permanently discontinued its operations in Malaysia. Impairment charges relating to intangible assets recorded during the three months ended June 30, 2021 were as follows: Intellectual property ($0.5 million), Customer contracts/relationships ($0.4 million) and, Trade names ($0.1 million).

ASSET IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS

6 Months Ended

Jun. 30, 2021

ASSET IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS [Abstract]

ASSET IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS

NOTE 12 — ASSET IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS:

The Company recorded an impairment loss of $1.3 million for the three and six months ended June 30, 2021 as the result of its write-off of the intangible assets, net, leasehold improvements, net and right-of-use assets for leases, net associated with its Malaysian operations that underwent a retrenchment during the second quarter of 2020. During the three months ended June 30, 2021, the Company was informed that the World Health Organization had prioritized its review of prequalification of the manufacture of the Company’s HIV 1/2 STAT-PAK Assay on its U.S. automated manufacturing processes, which would reduce the Company’s reliance on manual labor that otherwise could have been performed at the Malaysian facilities had the Company re-started operations there. During July 2021, the World Health Organization approved the change notification. The products produced on the Company’s automated and manual production lines at any time depend on, among other things, the timing of customer orders and the mix of products being produced.

In light of the uncertainty of the timing and any receipt of those regulatory approvals, the timing of progress on and results of clinical trial programs, and the timing and any receipt of product orders from the commercialization of our COVID-19 and other diagnostic test systems both within and outside the United States, during the second quarter of 2021 the Company engaged the services of an independent financial advisory firm. The independent financial advisory firm worked with management to develop a forecast model to assess the amount and timing of the Company’s liquidity needs, assuming various business cases, and together with legal counsel advised the Company regarding alternative approaches to enhancing its liquidity position, participating in discussions with the Lender, and related matters. During the three months ended June 30, 2021, the Company incurred $0.7 million related to these restructuring matters.

In order to address challenging economic conditions and implement its business strategy, in the first quarter of 2021 the Company continued to execute a program to reduce operating expenses and better align costs with revenues, including by eliminating positions that were no longer aligned with its strategy, and recognized severance charges of $0.1 million.

The table below represents the total costs by category for the periods ending:

	For the three months ended June 30, 2021		For the six months ended June 30, 2021
Severance	$	-	$	83,087
Restructuring costs		687,211		687,211
Asset impairment		1,273,945		1,273,945
	$	1,961,156	$	2,044,243

SUBSEQUENT EVENTS

6 Months Ended

Jun. 30, 2021

SUBSEQUENT EVENTS [Abstract]

SUBSEQUENT EVENTS

NOTE 13 — SUBSEQUENT EVENTS:

(a) At the Market Offering of Common Stock

On July 19, 2021, Chembio entered into the ATM Agreement with Craig‑Hallum, pursuant to which Chembio can sell from time to time, at its option, up to an aggregate of $60,000,000 of shares of common stock (the “Shares”) through Craig‑Hallum, as sales agent. Any sales of Shares made pursuant to the ATM Agreement is to be made pursuant to Chembio’s shelf registration statement on Form S 3 (File No. 333-254261) and the related prospectus previously declared effective by the SEC on May 5, 2021, as supplemented by a prospectus supplement dated July 19, 2021 that Chembio filed with the SEC, pursuant to Rule 424(b)(5) under the Securities Act on July 19, 2021, as such prospectus supplement may be amended or supplemented from time to time.

Prior to any sale of Shares under the ATM Agreement, Chembio is to deliver a sales notice to Craig‑Hallum that will set the parameters for such sale, including the number of Shares to be issued and sold, the time period during which such sale is requested to be made, any limitation on the number of Shares that may be sold in any one trading day and any minimum price below which Sales may not be made. Under the ATM Agreement, Craig‑Hallum is required to use commercially reasonable efforts consistent with its normal trading and sales practices to sell Shares in accordance with the terms of the ATM Agreement and any applicable sales notice.

Subject to the terms and conditions of the ATM Agreement, Craig‑Hallum may sell any Shares only by methods deemed to be an “at the market” offering as defined in Rule 415 under the Securities Act, including sales made directly through the Nasdaq Capital Market, by means of ordinary brokers’ transactions, in negotiated transactions, to or through a market maker other than on an exchange or otherwise, at market prices prevailing at the time of sale, at prices related to such prevailing market prices, or at negotiated prices and/or any other method permitted by law. If any sale of Shares pursuant to the ATM Agreement is not made directly on the Nasdaq Capital Market or any other existing trading market for Chembio’s common stock at market prices at the time of sale, including a sale to Craig‑Hallum acting as principal or a sale in a privately negotiated transactions, Chembio must file a prospectus supplement describing the terms of such sale, the number of Shares sold, the price of the Shares, the applicable compensation, and such other information as may be required pursuant to Rules 424 and 430B under the Securities Act, as applicable, within the time required by Rule 424 under the Securities Act.

Under the terms of the ATM Agreement, Chembio is to pay Craig‑Hallum a placement fee of 3.5% of the gross sales price of Shares sold, unless Craig‑Hallum acts as principal, in which case Chembio may sell the Shares to Craig‑Hallum as principal at a price it agrees upon with Craig‑Hallum. Chembio is obligated to reimburse Craig‑Hallum for certain expenses incurred in connection with the ATM Agreement, and it has provided Craig‑Hallum with customary indemnification and contribution rights with respect to certain liabilities, including liabilities under the Securities Act and the Exchange Act.

The offering of Shares pursuant to the ATM Agreement will terminate upon the earliest of (a) the sale of all of the Shares, (b) the mutual written agreement of Craig‑Hallum and Chembio, (c) written notice from Craig‑Hallum, in its sole discretion, to us, and (d) five business days’ prior written notice from Chembio, in its sole discretion, to Craig‑Hallum.

See Note 2(a)—Basis of Presentation.

(b) Issuance of Common Shares

As of the date of the issuance of these financial statements, Chembio had issued and sold pursuant to the ATM Agreement a total of 8,323,242 Shares at a volume-weighted average price of $4.4303 per Share for gross proceeds of approximately $36.9 million and net proceeds, after giving effect to placement fees and other estimated transaction costs, of approximately $34.7 million.

In July 2021 the Company received two customer purchase orders that the Company had been pursuing for an extended period of time. The delivery of the full number of tests covered by each of these purchase orders may be affected by limitations of the Company’s supply chain, staffing and liquidity, including matters that are outside the Company’s control. While the Company has established internal plans for delivery of the tests contemplated by the purchase orders, the number of uncertainties related to third parties — including the availability of required personnel and supplies — currently preclude the Company from accurately estimating the extent to which the Company will be able to fulfill the purchase orders on time and at an acceptable cost or at all.

•	On July 20, 2021, the Company received a $28.3 million purchase order from Bio-Manguinhos for the purchase of DPP SARS-CoV-2 Antigen tests for delivery during 2021 to support the needs of Brazil’s Ministry of Health in addressing the COVID-19 pandemic.

•	On July 22, 2021, the Company received a $4.0 million purchase order from the Partnership for Supply Chain Management, supported by The Global Fund, for the purchase of HIV 1/2 STAT-PAK Assays for shipment to Ethiopia into early 2022.

SIGNIFICANT ACCOUNTING POLICIES (Policies)

6 Months Ended

Jun. 30, 2021

SIGNIFICANT ACCOUNTING POLICIES [Abstract]

Basis of Presentation

(a)

Basis of Presentation:

Going Concern Considerations

Following June 30, 2021, as discussed in Note 16 – Subsequent Events, the Company undertook measures to increase its total revenues and improve its liquidity position:

•	The Company received significant purchase orders from two customers. The Company had pursued the purchase orders for an extended period of time, but did not receive them until July 2021 as follows:

•

•	On July 22, 2021, the Company received a $4 million purchase order from the Partnership for Supply Chain Management, supported by The Global Fund, for the purchase of HIV 1/2 STAT-PAK Assays for shipment to Ethiopia into early 2022.

•

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:

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 2020-10, Codification Improvements

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

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

ASU 2021-01—Reference Rate Reform (Topic 848)

Not Yet Adopted

- 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)

6 Months Ended

Jun. 30, 2021

REVENUE [Abstract]

Disaggregation of Revenue

The following table disaggregates Total Revenues:

	For the three months ended
	June 30, 2021						June 30, 2020
	Exchange Transactions		Non-Exchange Transactions		Total		Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	3,931,383	$	-	$	3,931,383	$	3,791,574	$	-	$	3,791,574
R&D revenue		727		-		727		1,193,973		-		1,193,973
Government grant income		-		2,280,000		2,280,000		-		-		-
License and royalty revenue		250,000		-		250,000		125,625		-		125,625
	$	4,182,110	$	2,280,000	$	6,462,110	$	5,111,172	$	-	$	5,111,172

	For the six months ended
	June 30, 2021						June 30, 2020
	Exchange Transactions		Non-Exchange Transactions		Total		Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	7,956,045	$	-	$	7,956,045	$	9,508,166	$	-	$	9,508,166
R&D revenue		1,107,366		-		1,107,366		2,101,660		-		2,101,660
Government grant income		-		5,630,000		5,630,000		-		-		-
License and royalty revenue		493,058		-		493,058		360,929		-		360,929
	$	9,556,469	$	5,630,000	$	15,186,469	$	11,970,755	$	-	$	11,970,755

The following table disaggregates Total Revenues by geographic location:

	For the three months ended				For the six months ended
	June 30, 2021		June 30, 2020		June 30, 2021		June 30, 2020
Africa	$	1,466,356	$	552,570	$	2,811,214	$	1,436,085
Asia		53,592		119,319		270,547		482,607
Europe & Middle East		806,209		1,635,017		3,406,485		3,811,172
Latin America		487,517		780,567		745,536		2,896,963
United States		3,648,436		2,023,699		7,952,687		3,343,928
	$	6,462,110	$	5,111,172	$	15,186,469	$	11,970,755

INVENTORY (Tables)

6 Months Ended

Jun. 30, 2021

INVENTORY [Abstract]

Inventories

Inventories are presented net of reserves and consisted of the following:

	June 30, 2021		December 31, 2020
Raw materials	$	6,611,511	$	5,955,215
Work in process		6,921,768		2,549,516
Finished goods		2,187,013		4,011,671
	$	15,720,292	$	12,516,402

COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS (Tables)

6 Months Ended

Jun. 30, 2021

COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS [Abstract]

Customer 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										For the six months ended										Accounts Receivable as of
	June 30, 2021					June 30, 2020					June 30, 2021					June 30, 2020					June 30, 2021		December. 31, 2020
	Sales		% of Sales			Sales		% of Sales			Sales		% of Sales			Sales		% of Sales
Customer 1	$	1,014,638		25.8	%	$	*		*		$	1,151,615		14.5	%	$	*		*		$	376,075	$	*
Customer 2		*		*			657,304		17.0	%		*		*			2,297,376		24.0	%		*		806,196

Components of Lease Expense

The components of lease expense were as follows:

	Three months ended June 30,				Six months ended June 30,
	2021		2020		2021		2020
Operating lease expense	$	402,329	$	388,951	$	810,795	$	852,808

Finance lease cost
Amortization of right-of-use assets	$	17,038	$	14,687	$	32,796	$	27,085
Interest on lease liabilities		5,368		5,156		10,312		9,367
Total finance lease expense	$	22,406	$	19,843	$	43,108	$	36,452

Supplemental Cash Flow Information Related to Leases

Supplemental cash flow information related to leases was as follows:

	Three months ended June 30,				Six months ended June 30,
	2021		2020		2021		2020
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows for operating leases	$	348,317	$	292,058	$	696,188	$	457,277
Operating cash flows for finance leases		5,368		5,156		10,312		9,367
Financing cash flows for finance leases		15,538		12,666		29,820		23,578
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	694,668	$	-	$	694,668	$	-
Finance leases		25,609		47,499		25,609		75,852

Supplemental Balance Sheet Information Related to Leases

Supplemental balance sheet information related to leases was as follows:

	June 30, 2021			June 30, 2020
Finance Leases
Finance lease right-of-use asset	$	340,762		$	309,574
Accumulated depreciation		(114,815	)		(50,690	)
Finance lease right-of-use asset, net	$	225,947		$	258,884

Weighted-Average Remaining Lease Term
Operating leases	7.9 Years			9.0 Years
Finance leases	3.4 Years			4.0 Years

Weighted-Average Discount Rate
Operating leases		8.73	%		8.62	%
Finance leases		8.43	%		9.73	%

Maturities of Lease Liabilities

Maturities of lease liabilities were as follows:

	June 30, 2021				June 30, 2020
	Operating Leases		Finance Leases		Operating Leases		Finance Leases
2020 and 2021	$	708,344	$	41,812	$	682,667	$	37,720
2022		1,447,249		83,624		1,209,787		75,440
2023		1,221,017		83,624		1,057,757		75,440
2024		1,018,875		55,856		1,026,272		75,440
2025		1,049,442		12,471		1,018,875		47,672
Thereafter		4,724,446		1,680		5,773,887		4,775
Total lease payments	$	10,169,373	$	279,067	$	10,769,245	$	316,487
Less: imputed interest		2,909,688		39,166		3,427,535		50,366
Total	$	7,259,685	$	239,901	$	7,341,710	$	266,121

EQUITY INCENTIVE PLAN (Tables)

6 Months Ended

Jun. 30, 2021

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 June 30				For the six months ended June 30
	2021		2020		2021		2020
Cost of product sales	$	43,368	$	-	$	72,136	$	6,300
Research and development expenses		139,469		90,924		223,704		154,737
Selling, general and administrative expenses		403,007		293,301		869,792		610,089
Severance and related costs		-		-		-		(423,985	)
	$	585,844	$	384,225	$	1,165,632	$	347,141

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 June 30, 2021			For the six months ended June 30, 2021
Expected term (in years)		6.0			5.0
Expected volatility		76.42	%		78.23	%
Expected dividend yield		1.01	%		0.81	%
Risk-free interest rate		2.03	%		2.93	%

Stock Option Activity

The following table provides stock option activity for the six months ended June 30, 2021:

Stock Options	Number of Shares	Weighted Average Exercise Price per Share		Weighted Average Remaining Contract Term	Aggregate Intrinsic Value
Outstanding at December 31, 2020	974,778	$	4.12	2.87 years	$	1,520,910

Granted	925,949		4.73			-
Exercised	-		-			-
Forfeited	8,682		5.89			-
Expired	25,000		5.64
Outstanding at June 30, 2021	1,867,045	$	4.40	7.08 years	$	388,182
Exercisable at June 30, 2021	526,210	$	4.79	4.28 years	$	173,621

Stock Options Outstanding

The following table summarizes information about stock options outstanding at June 30, 2021:

	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		636,364		5.71	$	2.36	$	388,182		284,624	$	2.36	$	173,621
2.8 to 4.59999		27,502		9.92		3.11		-		-		-		-
4.6 to 6.39999		946,514		9.16		4.81		-		14,961		5.49		-
6.4 to 8.19999		209,790		2.62		7.30		-		198,500		7.27		-
8.2 to 12		46,875		2.10		11.45		-		28,125		11.45		-
Total		1,867,045		7.08	$	4.40	$	388,182		526,210	$	4.79	$	173,621

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 June 30, 2021:

	Number of Shares & Units		Weighted Average Grant Date Fair Value
Outstanding at December 31, 2020		603,531	$	3.08

Granted		334,564		4.66
Vested		130,907		2.36
Forfeited		4,126		5.34
Outstanding at June 30, 2021		803,062	$	3.67

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY (Tables)

6 Months Ended

Jun. 30, 2021

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract]

Product Revenue by Geographic Area

	For the three months ended June 30,				For the six months ended June 30,
	2021		2020		2021		2020
Africa	$	1,466,356	$	552,570	$	2,811,215	$	1,436,085
Asia		53,593		119,319		270,547		482,607
Europe & Middle East		805,482		734,073		2,299,216		1,909,162
Latin America		487,517		780,567		745,536		2,896,963
United States		1,118,435		1,605,045		1,829,531		2,783,349
	$	3,931,383	$	3,791,574	$	7,956,045	$	9,508,166

Long-lived Assets by Geographic Area

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

	June 30, 2021		December 31, 2020
Asia	$	132,681	$	326,267
Europe & Middle East		130,185		147,692
Latin America		34,014		14,719
United States		8,852,580		8,199,725
	$	9,149,460	$	8,688,403

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Tables)

6 Months Ended

Jun. 30, 2021

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract]

Accounts Payable and Accrued Liabilities

Accounts payable and accrued liabilities consisted of:

	June 30, 2021		December 31, 2020
Accounts payable – suppliers	$	5,896,027	$	5,727,781
Accrued commissions and royalties		586,341		807,708
Accrued payroll		223,111		277,908
Accrued vacation		525,137		417,238
Accrued bonuses		234,000		1,193,985
Accrued severance		-		511,681
Accrued expenses – other		626,752		1,106,489
TOTAL	$	8,091,368	$	10,042,790

GOODWILL, LONG-LIVED ASSETS and INTANGIBLE ASSETS (Tables)

6 Months Ended

Jun. 30, 2021

GOODWILL, LONG-LIVED ASSETS and INTANGIBLE ASSETS [Abstract]

Changes in Goodwill

The following table reflects changes in goodwill:

Beginning balance at December 31, 2020	$	5,963,744
Change in foreign currency exchange rate		(64,213	)
Balance at June 30, 2021	$	5,899,531

Intangible Assets

Intangible assets consisted of the following at:

			June 30, 2021						December 31, 2020
	Weighted Average Remaining Useful Life		Cost		Accumulated Amortization		Net Book Value		Cost		Accumulated Amortization		Net Book Value
Intellectual property		7	$	775,801	$	166,366	$	609,435	$	1,638,699	$	472,190	$	1,166,509
Developed technology		5		2,036,368		709,538		1,326,830		2,102,526		594,186		1,508,340
Customer contracts/relationships		6		539,461		145,867		393,594		1,323,424		423,093		900,331
Trade names		7		4,231		4,231		-		115,318		44,512		70,806
			$	3,355,861	$	1,026,002	$	2,329,859	$	5,179,967	$	1,533,981	$	3,645,986

ASSET IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS (Tables)

6 Months Ended

Jun. 30, 2021

ASSET IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS [Abstract]

Total Costs

The table below represents the total costs by category for the periods ending:

	For the three months ended June 30, 2021		For the six months ended June 30, 2021
Severance	$	-	$	83,087
Restructuring costs		687,211		687,211
Asset impairment		1,273,945		1,273,945
	$	1,961,156	$	2,044,243

SIGNIFICANT ACCOUNTING POLICIES (Details)		1 Months Ended		3 Months Ended		6 Months Ended		12 Months Ended
SIGNIFICANT ACCOUNTING POLICIES (Details)	Jul. 19, 2021 USD ($)	Aug. 05, 2021 USD ($) shares	Jul. 31, 2021 PurchaseOrder	Jun. 30, 2021 USD ($) shares	Jun. 30, 2020 shares	Jun. 30, 2021 USD ($) shares	Jun. 30, 2020 shares	Jun. 30, 2022 USD ($)	Sep. 30, 2021 USD ($)	Sep. 30, 2020 USD ($)	Jul. 22, 2021 USD ($)	Jul. 20, 2021 USD ($)	Dec. 31, 2020 USD ($)
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents				$ 5,564,349		$ 5,564,349							$ 23,066,301
Cash and Cash Equivalents [Abstract]
Restricted cash				$ 400,000		$ 400,000							1,000,000.0
Income Taxes [Abstract]
Effective tax rate				(1.11%)	1.70%	0.51%	1.70%
Minimum [Member]
Credit Agreement [Abstract]
Covenant amount, revenue										$ 32,000,000.0
Maximum [Member]
Credit Agreement [Abstract]
Covenant amount, revenue										$ 50,100,000
Level 2 [Member]
Fair Value of Financial Instruments [Abstract]
Fair value of total debt				$ 20,000,000.0		$ 20,000,000.0							20,000,000.0
Carrying value				18,500,000		18,500,000							18,200,000
Subsequent Event [Member]
Purchase Order [Abstract]
Number of purchase orders received \| PurchaseOrder			2
Subsequent Event [Member] \| Bio- Manguinhos [Member]
Purchase Order [Abstract]
Amount of purchase order												$ 28,300,000
Subsequent Event [Member] \| Partnership for Supply Chain Management [Member]
Purchase Order [Abstract]
Amount of purchase order											$ 4,000,000.0
Subsequent Event [Member] \| Minimum [Member]
Credit Agreement [Abstract]
Covenant amount, revenue									$ 37,400,000
Subsequent Event [Member] \| Maximum [Member]
Credit Agreement [Abstract]
Covenant amount, revenue								$ 43,800,000
Subsequent Event [Member] \| Common Stock [Member]
Issuance of Common Stock [Abstract]
Gross proceeds from issuance of common stock		$ 34,700,000
Number of shares issued (in shares) \| shares		8,323,242
Net proceeds from issuance of common stock after deduction of placement fee and other transactions costs		$ 34,700,000
Subsequent Event [Member] \| At-the-Market Offering [Member] \| Craig-Hallum Capital Group LLC [Member] \| Maximum [Member]
Issuance of Common Stock [Abstract]
Aggregate shares of common stock sold	$ 60,000,000
Money Market Funds [Member] \| Level 1 [Member]
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents				$ 500,000		$ 500,000							$ 14,800,000
Options [Member]
Loss Per Share [Abstract]
Shares excluded from computation of earnings per share (in shares) \| shares				1,867,045	1,034,124	1,867,045	1,034,124
Restricted Shares [Member]
Loss Per Share [Abstract]
Shares excluded from computation of earnings per share (in shares) \| shares				803,062	619,385	803,062	619,385
Base common stock shares for restricted stock outstanding (in shares) \| shares				1	1	1	1

REVENUE (Details) - USD ($)	3 Months Ended		6 Months Ended
REVENUE (Details) - USD ($)	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020	Mar. 31, 2021	Dec. 31, 2020
Disaggregation of Revenue [Abstract]
Revenues	$ 6,462,110	$ 5,111,172	$ 15,186,469	$ 11,970,755
Deferred revenue	404,486		404,486		$ 400,000	$ 1,606,997
Deferred revenue earned and recognized	0
Deferred revenue expected to be recognized	400,000
Africa [Member]
Disaggregation of Revenue [Abstract]
Revenues	1,466,356	552,570	2,811,214	1,436,085
Asia [Member]
Disaggregation of Revenue [Abstract]
Revenues	53,592	119,319	270,547	482,607
Europe & Middle East [Member]
Disaggregation of Revenue [Abstract]
Revenues	806,209	1,635,017	3,406,485	3,811,172
Latin America [Member]
Disaggregation of Revenue [Abstract]
Revenues	487,517	780,567	745,536	2,896,963
United States [Member]
Disaggregation of Revenue [Abstract]
Revenues	3,648,436	2,023,699	7,952,687	3,343,928
Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	4,182,110	5,111,172	9,556,469	11,970,755
Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	2,280,000	0	5,630,000	0
Net Product Sales [Member]
Disaggregation of Revenue [Abstract]
Revenues	3,931,383	3,791,574	7,956,045	9,508,166
Net Product Sales [Member] \| Africa [Member]
Disaggregation of Revenue [Abstract]
Revenues	1,466,356	552,570	2,811,215	1,436,085
Net Product Sales [Member] \| Asia [Member]
Disaggregation of Revenue [Abstract]
Revenues	53,593	119,319	270,547	482,607
Net Product Sales [Member] \| Europe & Middle East [Member]
Disaggregation of Revenue [Abstract]
Revenues	805,482	734,073	2,299,216	1,909,162
Net Product Sales [Member] \| Latin America [Member]
Disaggregation of Revenue [Abstract]
Revenues	487,517	780,567	745,536	2,896,963
Net Product Sales [Member] \| United States [Member]
Disaggregation of Revenue [Abstract]
Revenues	1,118,435	1,605,045	1,829,531	2,783,349
Net Product Sales [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	3,931,383	3,791,574	7,956,045	9,508,166
Net Product Sales [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	0	0	0	0
R&D Revenue [Member]
Disaggregation of Revenue [Abstract]
Revenues	727	1,193,973	1,107,366	2,101,660
R&D Revenue [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	727	1,193,973	1,107,366	2,101,660
R&D Revenue [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	0	0	0	0
Government Grant Income [Member]
Disaggregation of Revenue [Abstract]
Revenues	2,280,000	0	5,630,000	0
Government Grant Income [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	0	0	0	0
Government Grant Income [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	2,280,000	0	5,630,000	0
License and Royalty Revenue [Member]
Disaggregation of Revenue [Abstract]
Revenues	250,000	125,625	493,058	360,929
License and Royalty Revenue [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	250,000	125,625	493,058	360,929
License and Royalty Revenue [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Revenues	$ 0	$ 0	$ 0	$ 0

INVENTORY (Details) - USD ($)	3 Months Ended	6 Months Ended
INVENTORY (Details) - USD ($)	Jun. 30, 2021	Jun. 30, 2021	Jun. 30, 2020	Dec. 31, 2020
INVENTORY [Abstract]
Raw materials	$ 6,611,511	$ 6,611,511		$ 5,955,215
Work in process	6,921,768	6,921,768		2,549,516
Finished goods	2,187,013	2,187,013		4,011,671
Inventories	15,720,292	15,720,292		$ 12,516,402
Charges [Abstract]
Charge related to write-down of inventory	$ 900,000	$ 863,612	$ 0

STOCKHOLDERS' EQUITY (Details) - shares	3 Months Ended		6 Months Ended
STOCKHOLDERS' EQUITY (Details) - shares	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020	Dec. 31, 2020
Common Stock [Abstract]
Number of stock options exercised under the plan (in shares)	0	0	0	0
Preferred Stock [Abstract]
Preferred stock - shares authorized (in shares)	10,000,000		10,000,000		10,000,000
Preferred stock - shares issued (in shares)	0		0		0
Preferred stock - shares outstanding (in shares)	0		0		0
Treasury Stock [Abstract]
Treasury stock, shares (in shares)	41,141		41,141		41,141

COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS (Details)			3 Months Ended		6 Months Ended		12 Months Ended
	Mar. 19, 2021 Claim	Jan. 03, 2020 USD ($) shares	Jun. 30, 2021 USD ($) KeyEmployee Applicants	Jun. 30, 2020 USD ($)	Jun. 30, 2021 USD ($) KeyEmployee Claim	Jun. 30, 2020 USD ($)	Dec. 31, 2020 USD ($) Lawsuit
Concentrations [Abstract]
Revenues			$ 6,462,110	$ 5,111,172	$ 15,186,469	$ 11,970,755
Accounts Receivable			$ 2,977,082		$ 2,977,082		$ 3,377,387
Employment Contracts [Abstract]
Number of key employees with whom Company has employment contracts \| KeyEmployee			2		2
Aggregate annual salaries of employment contracts					$ 843,292
Contract expiration date					Dec. 31, 2021
Future minimum salary commitments [Abstract]
2021			$ 421,646		$ 421,646
2022			460,000		$ 460,000
Benefit Plan [Abstract]
Percentage of employer's matching contribution					40.00%
Expenses related to matching contribution			29,933	35,456	$ 65,388	49,407
Components of Lease Expense [Abstract]
Operating lease expense			402,329	388,951	810,795	852,808
Finance lease cost [Abstract]
Amortization of right-of-use assets			17,038	14,687	32,796	27,085
Interest on lease liabilities			5,368	5,156	10,312	9,367
Total finance lease expense			22,406	19,843	43,108	36,452
Cash paid for amounts included in the measurement of lease liabilities [Abstract]
Operating cash flows for operating leases			348,317	292,058	696,188	457,277
Operating cash flows for finance leases			5,368	5,156	10,312	9,367
Financing cash flows for finance leases			15,538	12,666	29,820	23,578
Right-of-use assets obtained in exchange for lease obligations [Abstract]
Operating leases			694,668	0	694,668	0
Finance leases			25,609	47,499	25,609	75,852
Finance Leases [Abstract]
Finance lease right-of-use asset			340,762	309,574	340,762	309,574
Accumulated depreciation			(114,815)	(50,690)	(114,815)	(50,690)
Finance lease right-of-use asset, net			$ 225,947	$ 258,884	$ 225,947	$ 258,884	$ 233,134
Weighted Average Remaining Lease Term [Abstract]
Operating leases			7 years 10 months 24 days	9 years	7 years 10 months 24 days	9 years
Finance leases			3 years 4 months 24 days	4 years	3 years 4 months 24 days	4 years
Weighted Average Discount Rate [Abstract]
Operating leases			8.73%	8.62%	8.73%	8.62%
Finance leases			8.43%	9.73%	8.43%	9.73%
Maturities of Operating Lease Liabilities [Abstract]
2020 and 2021			$ 708,344	$ 682,667	$ 708,344	$ 682,667
2022			1,447,249	1,209,787	1,447,249	1,209,787
2023			1,221,017	1,057,757	1,221,017	1,057,757
2024			1,018,875	1,026,272	1,018,875	1,026,272
2025			1,049,442	1,018,875	1,049,442	1,018,875
Thereafter			4,724,446	5,773,887	4,724,446	5,773,887
Total lease payments			10,169,373	10,769,245	10,169,373	10,769,245
Less: imputed interest			2,909,688	3,427,535	2,909,688	3,427,535
Total			7,259,685	7,341,710	7,259,685	7,341,710
Maturities of Finance Lease Liabilities [Abstract]
2020 and 2021			41,812	37,720	41,812	37,720
2022			83,624	75,440	83,624	75,440
2023			83,624	75,440	83,624	75,440
2024			55,856	75,440	55,856	75,440
2025			12,471	47,672	12,471	47,672
Thereafter			1,680	4,775	1,680	4,775
Total lease payments			279,067	316,487	279,067	316,487
Less: imputed interest			39,166	50,366	39,166	50,366
Total			$ 239,901	266,121	$ 239,901	266,121
Stockholder Litigation [Abstract]
Number of class action lawsuits \| Lawsuit							4
Number of motions for appointment as lead plaintiff \| Applicants			8
Number of motions abandoned \| Applicants			2
Number of remaining motions for appointment as lead plaintiff \| Applicants			2
Number of motions filed by special situations funds \| Applicants			1
Number of motions filed by municipal employees retirement system \| Applicants			1
Employee Litigation [Abstract]
Number of filed complaint \| Claim	15
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					10
Loss contingency, asserting damages amount					$ 3,190,198
Loss contingency, asserting damages excess amount					$ 3,000,000
Prejudgment interest rate			9.00%		9.00%
Vendor [Member]
Concentrations [Abstract]
Purchases			$ 0		$ 0
Customer Concentration Risk [Member] \| Customer 1 [Member]
Concentrations [Abstract]
Accounts Receivable			376,075		376,075
Customer Concentration Risk [Member] \| Customer 2 [Member]
Concentrations [Abstract]
Accounts Receivable							$ 806,196
Maximum [Member]
Benefit Plan [Abstract]
Employee contribution subject to employer matching contribution					5.00%
Employer matching contribution					2.00%
Employee Litigation [Abstract]
Loss contingency, claims entitlement to recover damages amount					$ 10,000,000
Malaysia [Member]
Leases [Abstract]
Impairment charges			100,000		100,000
Sales [Member] \| Customer Concentration Risk [Member] \| Customer 1 [Member]
Concentrations [Abstract]
Revenues			$ 1,014,638		$ 1,151,615
Concentration risk, percentage			25.80%		14.50%
Sales [Member] \| Customer Concentration Risk [Member] \| Customer 2 [Member]
Concentrations [Abstract]
Revenues				$ 657,304		$ 2,297,376
Concentration risk, percentage				17.00%		24.00%

LONG-TERM DEBT, Credit Agreement (Details) - USD ($)		6 Months Ended	12 Months Ended
LONG-TERM DEBT, Credit Agreement (Details) - USD ($)	Sep. 03, 2019	Jun. 30, 2021	Sep. 30, 2020	Jun. 30, 2020
Minimum [Member]
Credit Agreement [Abstract]
Covenant amount, unrestricted cash		$ 3,000,000
Covenant amount, revenue			$ 32,000,000.0
Maximum [Member]
Credit Agreement [Abstract]
Covenant amount, revenue			$ 50,100,000
Senior Secured Term Loan Credit Facility [Member]
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		$ 18,500,000
Senior Secured Term Loan Credit Facility [Member] \| LIBOR [Member]
Credit Agreement [Abstract]
Term of variable rate		1 month
Basis spread on variable rate	2.50%
Senior Secured Term Loan Credit Facility [Member] \| September 4, 2020 to September 3 ,2021 [Member]
Credit Agreement [Abstract]
Percentage of prepaid principal as premium	8.00%
Senior Secured Term Loan Credit Facility [Member] \| September 4, 2021 to September 3 ,2022 [Member]
Credit Agreement [Abstract]
Percentage of prepaid principal as premium	4.00%

EQUITY INCENTIVE PLAN, Part 1 (Details) - USD ($)				3 Months Ended		6 Months Ended		12 Months Ended
EQUITY INCENTIVE PLAN, Part 1 (Details) - USD ($)	Jun. 25, 2021	Jan. 03, 2020	Sep. 22, 2011	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020	Dec. 31, 2020	Jun. 18, 2019	Jun. 19, 2014	Jun. 03, 2008
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense				$ 585,844	$ 384,225	$ 1,165,632	$ 347,141
Stock options, additional disclosure [Abstract]
Outstanding, aggregate intrinsic value, end of period				388,182		388,182
Exercisable, aggregate intrinsic value, end of period				$ 173,621		$ 173,621
Total fair value of stock options vested during period		$ 943,126
Stock Options [Member]
Assumptions made in calculating fair values of options [Abstract]
Expected term				6 years		5 years
Expected volatility				76.42%		78.23%
Expected dividend yield				1.01%		0.81%
Risk-free interest rate				2.03%		2.93%
Stock options, number of shares [Roll forward]
Outstanding, beginning of period (in shares)						974,778
Granted (in shares)						925,949
Exercised (in shares)						0
Forfeited (in shares)						8,682
Expired (in shares)						25,000
Outstanding, end of period (in shares)				1,867,045		1,867,045		974,778
Exercisable, end of period (in shares)				526,210		526,210
Stock options, weighted average exercise price per share [Roll Forward]
Outstanding, beginning of period (in dollars per share)						$ 4.12
Granted (in dollars per share)						4.73
Exercised (in dollars per share)						0
Forfeited (in dollars per share)						5.89
Expired (in dollars per share)						5.64
Outstanding, end of period (in dollars per share)				$ 4.40		4.40		$ 4.12
Exercisable, end of period (in dollars per share)				$ 4.79		$ 4.79
Stock options, additional disclosure [Abstract]
Outstanding, weighted average remaining contract term						7 years 29 days		2 years 10 months 13 days
Exercisable, weighted average remaining contract term						4 years 3 months 10 days
Outstanding, aggregate intrinsic value, beginning of period						$ 1,520,910
Granted, aggregate intrinsic value						0
Exercised, aggregate intrinsic value						0
Forfeited, aggregate intrinsic value						0
Outstanding, aggregate intrinsic value, end of period				$ 388,182		388,182		$ 1,520,910
Exercisable, aggregate intrinsic value, end of period				173,621		173,621
Net unrecognized compensation cost				$ 2,907,843		$ 2,907,843
Weighted average period for recognition of net unrecognized compensation cost						2 years 10 months 20 days
Total fair value of stock options vested during period						$ 335,579	112,311
2008 Stock Incentive Plan [Member] \| Stock Options [Member]
Share-based Arrangements with Employees and Nonemployees [Abstract]
Number of shares authorized under the plan (in shares)			750,000								625,000
Increase in number of shares authorized (in shares)			125,000
Number of stock options expired, forfeited or exercised under the plan (in shares)						714,000
Options still available to be issued (in shares)				0		0
Stock options, number of shares [Roll forward]
Outstanding, end of period (in shares)				36,000		36,000
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)						519,782
Options still available to be issued (in shares)				0		0
Stock options, number of shares [Roll forward]
Outstanding, end of period (in shares)				259,157		259,157
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)						440,310
Options still available to be issued (in shares)				2,658,522		2,658,522
Stock options, number of shares [Roll forward]
Outstanding, end of period (in shares)				2,219,224		2,219,224
2014 & 2019 Stock Incentive Plan [Member] \| Stock Options [Member]
Stock options, number of shares [Roll forward]
Outstanding, end of period (in shares)				21,061		21,061
Cost of Product Sales [Member]
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense				$ 43,368	0	$ 72,136	6,300
Research and Development Expenses [Member]
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense				139,469	90,924	223,704	154,737
Selling, General and Administrative Expenses [Member]
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense				403,007	293,301	869,792	610,089
Severance and Related Costs [Member]
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense				$ 0	$ 0	$ 0	$ (423,985)

EQUITY INCENTIVE PLANS, Part 2 (Details)	6 Months Ended
EQUITY INCENTIVE PLANS, Part 2 (Details)	Jun. 30, 2021 USD ($) $ / shares shares
Stock Options Outstanding [Abstract]
Shares outstanding (in shares) \| shares	1,867,045
Average remaining contract term	7 years 29 days
Weighted average exercise price (in dollars per share)	$ 4.40
Aggregate intrinsic value \| $	$ 388,182
Stock Options Exercisable [Abstract]
Shares exercisable (in shares) \| shares	526,210
Weighted average exercise price (in dollars per share)	$ 4.79
Aggregate intrinsic value \| $	$ 173,621
1 to 2.79999 [Member]
Range of Exercise Prices [Abstract]
Range of exercise prices, minimum (in dollars per share)	$ 1
Range of exercise prices, maximum (in dollars per share)	$ 2.79999
Stock Options Outstanding [Abstract]
Shares outstanding (in shares) \| shares	636,364
Average remaining contract term	5 years 8 months 15 days
Weighted average exercise price (in dollars per share)	$ 2.36
Aggregate intrinsic value \| $	$ 388,182
Stock Options Exercisable [Abstract]
Shares exercisable (in shares) \| shares	284,624
Weighted average exercise price (in dollars per share)	$ 2.36
Aggregate intrinsic value \| $	$ 173,621
2.8 to 4.59999 [Member]
Range of Exercise Prices [Abstract]
Range of exercise prices, minimum (in dollars per share)	$ 2.8
Range of exercise prices, maximum (in dollars per share)	$ 4.59999
Stock Options Outstanding [Abstract]
Shares outstanding (in shares) \| shares	27,502
Average remaining contract term	9 years 11 months 1 day
Weighted average exercise price (in dollars per share)	$ 3.11
Aggregate intrinsic value \| $	$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares) \| shares	0
Weighted average exercise price (in dollars per share)	$ 0
Aggregate intrinsic value \| $	$ 0
4.6 to 6.39999 [Member]
Range of Exercise Prices [Abstract]
Range of exercise prices, minimum (in dollars per share)	$ 4.6
Range of exercise prices, maximum (in dollars per share)	$ 6.39999
Stock Options Outstanding [Abstract]
Shares outstanding (in shares) \| shares	946,514
Average remaining contract term	9 years 1 month 28 days
Weighted average exercise price (in dollars per share)	$ 4.81
Aggregate intrinsic value \| $	$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares) \| shares	14,961
Weighted average exercise price (in dollars per share)	$ 5.49
Aggregate intrinsic value \| $	$ 0
6.4 to 8.19999 [Member]
Range of Exercise Prices [Abstract]
Range of exercise prices, minimum (in dollars per share)	$ 6.4
Range of exercise prices, maximum (in dollars per share)	$ 8.19999
Stock Options Outstanding [Abstract]
Shares outstanding (in shares) \| shares	209,790
Average remaining contract term	2 years 7 months 13 days
Weighted average exercise price (in dollars per share)	$ 7.30
Aggregate intrinsic value \| $	$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares) \| shares	198,500
Weighted average exercise price (in dollars per share)	$ 7.27
Aggregate intrinsic value \| $	$ 0
8.2 to 12 [Member]
Range of Exercise Prices [Abstract]
Range of exercise prices, minimum (in dollars per share)	$ 8.2
Range of exercise prices, maximum (in dollars per share)	$ 12
Stock Options Outstanding [Abstract]
Shares outstanding (in shares) \| shares	46,875
Average remaining contract term	2 years 1 month 6 days
Weighted average exercise price (in dollars per share)	$ 11.45
Aggregate intrinsic value \| $	$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares) \| shares	28,125
Weighted average exercise price (in dollars per share)	$ 11.45
Aggregate intrinsic value \| $	$ 0

EQUITY INCENTIVE PLAN, Part 3 (Details) - Restricted Stock and Restricted Stock Units [Member]	6 Months Ended
	Jun. 30, 2021 USD ($) $ / shares shares
Number of Shares & Units [Abstract]
Outstanding, beginning of period (in shares) \| shares	603,531
Granted (in shares) \| shares	334,564
Vested (in shares) \| shares	130,907
Forfeited (in shares) \| shares	4,126
Outstanding, end of period (in shares) \| shares	803,062
Weighted Average Grant Date Fair Value [Abstract]
Outstanding, beginning of period (in dollars per share) \| $ / shares	$ 3.08
Granted (in dollars per share) \| $ / shares	4.66
Vested (in dollars per share) \| $ / shares	2.36
Forfeited (in dollars per share) \| $ / shares	5.34
Outstanding, end of period (in dollars per share) \| $ / shares	$ 3.67
Net unrecognized compensation cost \| $	$ 2,155,021
Weighted average period for recognition of net unrecognized compensation cost	2 years 6 months 3 days

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020	Dec. 31, 2020
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	$ 6,462,110	$ 5,111,172	$ 15,186,469	$ 11,970,755
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	9,149,460		9,149,460		$ 8,688,403
Impairment charges	1,273,945		1,273,945
Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	3,931,383	3,791,574	7,956,045	9,508,166
Africa [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	1,466,356	552,570	2,811,214	1,436,085
Africa [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	1,466,356	552,570	2,811,215	1,436,085
Asia [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	53,592	119,319	270,547	482,607
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	132,681		132,681		326,267
Asia [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	53,593	119,319	270,547	482,607
Europe & Middle East [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	806,209	1,635,017	3,406,485	3,811,172
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	130,185		130,185		147,692
Europe & Middle East [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	805,482	734,073	2,299,216	1,909,162
Latin America [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	487,517	780,567	745,536	2,896,963
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	34,014		34,014		14,719
Latin America [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	487,517	780,567	745,536	2,896,963
United States [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	3,648,436	2,023,699	7,952,687	3,343,928
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	8,852,580		8,852,580		$ 8,199,725
United States [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	1,118,435	$ 1,605,045	$ 1,829,531	$ 2,783,349
Malaysia [Member]
Geographic Areas, Long-Lived Assets [Abstract]
Impairment charges	$ 200,000

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Details) - USD ($)	Jun. 30, 2021	Dec. 31, 2020
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract]
Accounts payable - suppliers	$ 5,896,027	$ 5,727,781
Accrued commissions and royalties	586,341	807,708
Accrued payroll	223,111	277,908
Accrued vacation	525,137	417,238
Accrued bonuses	234,000	1,193,985
Accrued severance	0	511,681
Accrued expenses - other	626,752	1,106,489
TOTAL	$ 8,091,368	$ 10,042,790

GOODWILL, LONG-LIVED ASSETS and INTANGIBLE ASSETS (Details) - USD ($)	3 Months Ended	6 Months Ended
	Jun. 30, 2021	Jun. 30, 2021	Jun. 30, 2020	Dec. 31, 2020
Goodwill [Roll Forward]
Goodwill, Beginning balance		$ 5,963,744
Changes in foreign currency exchange rate		(64,213)
Goodwill, Ending balance	$ 5,899,531	5,899,531
Intangible assets [Abstract]
Cost	3,355,861	3,355,861		$ 5,179,967
Accumulated Amortization	1,026,002	1,026,002		1,533,981
Net Book Value	2,329,859	2,329,859		3,645,986
Amortization Expense [Abstract]
Amortization expense		264,608	$ 287,253
Amortization expense 2021	389,023	389,023
Amortization expense 2022	389,023	389,023
Amortization expense 2023	389,023	389,023
Amortization expense 2024	389,023	389,023
Amortization expense 2025	389,023	389,023
Amortization expense, thereafter	384,745	$ 384,745
Intellectual Property [Member]
Intangible assets [Abstract]
Weighted average remaining useful life of intangible assets		7 years
Cost	775,801	$ 775,801		1,638,699
Accumulated Amortization	166,366	166,366		472,190
Net Book Value	609,435	$ 609,435		1,166,509
Amortization Expense [Abstract]
Amortization period		10 years
Intellectual Property [Member] \| Malaysia [Member]
Amortization Expense [Abstract]
Impairment charges	500,000
Developed Technology [Member]
Intangible assets [Abstract]
Weighted average remaining useful life of intangible assets		5 years
Cost	2,036,368	$ 2,036,368		2,102,526
Accumulated Amortization	709,538	709,538		594,186
Net Book Value	1,326,830	$ 1,326,830		1,508,340
Amortization Expense [Abstract]
Amortization period		7 years
Customer Contracts / Relationships [Member]
Intangible assets [Abstract]
Weighted average remaining useful life of intangible assets		6 years
Cost	539,461	$ 539,461		1,323,424
Accumulated Amortization	145,867	145,867		423,093
Net Book Value	393,594	$ 393,594		900,331
Amortization Expense [Abstract]
Amortization period		10 years
Customer Contracts / Relationships [Member] \| Malaysia [Member]
Amortization Expense [Abstract]
Impairment charges	400,000
Trade Name [Member]
Intangible assets [Abstract]
Weighted average remaining useful life of intangible assets		7 years
Cost	4,231	$ 4,231		115,318
Accumulated Amortization	4,231	4,231		44,512
Net Book Value	0	$ 0		$ 70,806
Amortization Expense [Abstract]
Amortization period		11 years
Trade Name [Member] \| Malaysia [Member]
Amortization Expense [Abstract]
Impairment charges	$ 100,000

ASSET IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
ASSET IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS [Abstract]
Severance	$ 0		$ 83,087
Restructuring costs	687,211		687,211
Asset impairment	1,273,945		1,273,945
Total	$ 1,961,156	$ 387,540	$ 2,044,243	$ 1,110,658

SUBSEQUENT EVENTS (Details)		1 Months Ended		6 Months Ended
SUBSEQUENT EVENTS (Details)	Jul. 19, 2021 USD ($)	Aug. 05, 2021 USD ($) $ / shares shares	Jul. 31, 2021 PurchaseOrder	Jun. 30, 2021 USD ($)	Jun. 30, 2020 USD ($)	Jul. 22, 2021 USD ($)	Jul. 20, 2021 USD ($)
Issuance of Common Stock [Abstract]
Gross proceeds from issuance of common stock				$ 0	$ 28,436,741
Subsequent Event [Member]
Purchase Order [Abstract]
Number of purchase orders received \| PurchaseOrder			2
Subsequent Event [Member] \| Bio-Manguinhos [Member]
Purchase Order [Abstract]
Amount of purchase order							$ 28,300,000
Subsequent Event [Member] \| Partnership for Supply Chain Management [Member]
Purchase Order [Abstract]
Amount of purchase order						$ 4,000,000.0
Subsequent Event [Member] \| Common Stock [Member]
Issuance of Common Stock [Abstract]
Number of shares issued (in shares) \| shares		8,323,242
Volume-weighted average price per share \| $ / shares		$ 4.4303
Gross proceeds from issuance of common stock		$ 36,900,000
Net proceeds from issuance of common stock after deduction of placement fee and other transactions costs		$ 34,700,000
Subsequent Event [Member] \| ATM Offering [Member] \| Craig-Hallum [Member]
At the Market Offering of Common Shares [Abstract]
Number of trading days for sales notice	1 day
Percentage of placement fee on gross sales price	3.50%
Number of business days of prior written notice	5 days
Subsequent Event [Member] \| ATM Offering [Member] \| Craig-Hallum [Member] \| Maximum [Member]
At the Market Offering of Common Shares [Abstract]
Aggregate shares of common stock sold	$ 60,000,000