UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.

For the quarterly period ended September 30, 2020

OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from: ______ to ________

000-30379
(Commission File Number)

GRAPHIC

Chembio Diagnostics, Inc.
(Exact name of registrant as specified in its charter)

Nevada
 
88-0425691
(State or other jurisdiction of incorporation)
 
(IRS Employer Identification Number)

555 Wireless Blvd.
Hauppauge, NY 11788
(Address of principal executive offices including zip code)

(631) 924-1135
(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
 
Trading Symbol
 
Name of each exchange on which registered
Common Stock, $0.01 par value
 
CEMI
 
The NASDAQ Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 
Large accelerated filer ☐
Accelerated filer ☒
 
Non-accelerated filer ☐
Smaller reporting company ☒
 
Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Yes ☐ No ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No ☒

As of November 5, 2020, the registrant had 20,176,131 shares outstanding of its common stock, $.01 par value.


Quarterly Report on Form 10-Q
For The Quarterly Period Ended
September 30, 2020

Table of Contents

Chembio Diagnostics, Inc.

 
 
Page
 
 
 
3
 
 
 
Part I. FINANCIAL INFORMATION:
 
 
 
 
Item 1. Financial Statements:
 
 
 
 
 
4
 
 
 
 
5
 
 
 
 
6
 
 
 
 
7
 
 
 
 
9
 
 
 
 
10
 
 
 
 
30
 
 
 
 
47
 
 
 
Part II. OTHER INFORMATION:
 
 
 
 
 
49
 
 
 
 
51
 
 
 
 
53
 
 
 
54

Unless the context requires otherwise, the words ‘‘we,’’ ‘‘us,’’ ‘‘our,’’ ‘‘our company,’’ ‘‘Chembio’’ and similar terms refer to Chembio Diagnostics, Inc. and its consolidated subsidiaries.

DPP, STAT-PAK, STAT-VIEW and SURE CHECK are our registered trademarks, and CHEMBIO and MICRO READER are our trademarks. For convenience, these trademarks appear in this report without ® and ™ symbols, and that practice does not mean that we will not assert, to the fullest extent under applicable law, our rights to the trademarks.

FORWARD-LOOKING STATEMENTS AND STATISTICAL ESTIMATES

This report contains statements reflecting our views about our future performance that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are generally identified through the inclusion of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “objective,” “outlook,” “plan,” “potential,” “project,” “seek,” “should,” “strategy,” “target,” “will,” “would” or variations of such words or similar expressions. All statements addressing our future operating performance, and statements addressing events and developments that we expect or anticipate will occur in the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based upon currently available information, operating plans, and projections about future events and trends.

This report contains estimates, projections and other data concerning our industry, our business and the markets for our products. Where expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by the World Health Organization, or WHO. We also include data that we have compiled, obtained, identified or otherwise derived from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. Other than WHO, we do not expressly refer to the sources from which this data is derived.

Forward-looking statements and statistical estimates inherently involve risks and uncertainties that could cause actual results to differ materially from those predicted or expressed in this report. These risks and uncertainties include those described in Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as filed with the Securities and Exchange Commission on March 13, 2020, in Part II, Item 1A. "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020, as filed with the Securities and Exchange Commission on May 4, 2020, in Part II, Item 1A. "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020, as filed with the Securities and Exchange Commission on August 7, 2020, and in Part II, Item 1A, “Risk Factors,” of this report. You should interpret many of the risks identified in these reports as being heightened as a result of the ongoing and numerous adverse impacts of the COVID-19 pandemic. Investors are cautioned not to place undue reliance on any forward-looking statements or statistical estimates, which speak only as of the date they are made. We undertake no obligation to update any forward-looking statement or statistical estimate, whether as a result of new information, future events or otherwise.


PART I
Item 1.          FINANCIAL STATEMENTS
 CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
AS OF

  
(Unaudited)
September 30, 2020
    
December 31, 2019
  
- ASSETS -
            
CURRENT ASSETS:
            
Cash and cash equivalents
  
$
28,687,453
    
$
18,271,352
  
Accounts receivable, net of allowance for doubtful accounts of $276,210 and $62,000 as of September 30, 2020 and December 31, 2019, respectively
    
3,522,498
      
3,661,325
  
Inventories, net
    
12,363,486
      
9,598,030
  
Prepaid expenses and other current assets
    
1,007,473
      
693,013
  
TOTAL CURRENT ASSETS
    
45,580,910
      
32,223,720
  
                 
FIXED ASSETS:
                
Property, plant and equipment, net
    
8,033,112
      
5,933,569
  
Finance lease right-of-use asset, net
    
248,892
      
210,350
  
                 
OTHER ASSETS:
                
Operating lease right-of-use assets, net
    
6,316,221
      
7,030,744
  
Intangible assets, net
    
3,648,495
      
3,914,352
  
Goodwill
    
5,696,679
      
5,872,690
  
Deposits and other assets
    
462,664
      
543,539
  
                 
TOTAL ASSETS
  
$
69,986,973
    
$
55,728,964
  
                 
- LIABILITIES AND STOCKHOLDERS’ EQUITY -
                
CURRENT LIABILITIES:
                
Accounts payable and accrued liabilities
  
$
6,558,782
    
$
5,526,243
  
Deferred revenue
    
3,865,754
      
125,000
  
Finance lease liabilities
    
57,715
      
41,894
  
Operating lease liabilities
    
710,535
      
568,294
  
Note payable
    
-
      
180,249
  
TOTAL CURRENT LIABILITIES
    
11,192,786
      
6,441,680
  
                 
OTHER LIABILITIES:
                
Long-term operating lease liabilities
    
6,448,515
      
6,969,603
  
Long-term finance lease liabilities
    
200,397
      
171,953
  
Long-term debt, less current portion, net
    
18,040,427
      
17,644,149
  
Deferred tax liability
    
165,326
      
466,326
  
                 
TOTAL LIABILITIES
    
36,047,451
      
31,693,711
  
                 
COMMITMENTS AND CONTINGENCIES
    
     
 
                 
STOCKHOLDERS’ EQUITY:
                
Preferred stock - 10,000,000 shares authorized; none outstanding
    
-
      
-
  
Common stock - $0.01 par value; 100,000,000 shares authorized; 20,213,956 shares and 17,733,617 shares issued at September 30, 2020 and December 31, 2019, respectively
    
202,139
      
177,335
  
Additional paid-in capital
    
124,622,252
      
95,433,077
  
Accumulated deficit
    
(89,967,147
)
    
(71,585,003
)
Treasury stock - 33,290 and 0 shares at cost, at September 30, 2020 and December 31, 2019, respectively
    
(150,919
)
    
-
  
Accumulated other comprehensive (loss) income
    
(766,803
)
    
9,844
  
TOTAL STOCKHOLDERS’ EQUITY
    
33,939,522
      
24,035,253
  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
  
$
69,986,973
    
$
55,728,964
  

See accompanying notes to condensed consolidated financial statements


CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
 
  
For the Three Months Ended
    
For the Nine Months Ended
  
   
September 30, 2020
    
September 30, 2019
    
September 30, 2020
    
September 30, 2019
  
REVENUES:
                        
Net product sales
  
$
8,406,457
    
$
8,510,629
    
$
17,914,623
    
$
23,381,906
  
R&D and grant revenue
    
1,654,500
      
971,980
      
3,756,161
      
3,528,033
  
License and royalty revenue
    
211,521
      
238,330
      
572,450
      
703,352
  
TOTAL REVENUES
    
10,272,478
      
9,720,939
      
22,243,234
      
27,613,291
  
                                 
COSTS AND EXPENSES:
                                
Cost of product sales
    
7,467,746
      
6,649,114
      
17,512,925
      
18,112,676
  
Research and development expenses
    
2,351,880
      
2,223,939
      
6,233,040
      
6,542,591
  
Selling, general and administrative expenses
    
5,348,958
      
4,455,588
      
13,903,192
      
12,565,601
  
Severance, restructuring and other related costs
    
11,651
      
-
      
1,122,310
      
-
  
Acquisition costs
    
-
      
-
      
63,497
      
395,612
  
     
15,180,235
      
13,328,641
      
38,834,964
      
37,616,480
  
LOSS FROM OPERATIONS
    
(4,907,757
)
    
(3,607,702
)
    
(16,591,730
)
    
(10,003,189
)
                                 
OTHER INCOME:
                                
Interest expense, net
    
(735,819
)
    
(195,970
)
    
(2,110,011
)
    
(183,368
)
                                 
LOSS BEFORE INCOME TAXES
    
(5,643,576
)
    
(3,803,672
)
    
(18,701,741
)
    
(10,186,557
)
                                 
Income tax benefit
    
104,778
      
20,667
      
319,597
      
400,339
  
                                 
NET LOSS
  
$
(5,538,798
)
  
$
(3,783,005
)
  
$
(18,382,144
)
  
$
(9,786,218
)
                                 
Basic loss per share
  
$
(0.28
)
  
$
(0.22
)
  
$
(0.98
)
  
$
(0.58
)
                                 
Diluted loss per share
  
$
(0.28
)
  
$
(0.22
)
  
$
(0.98
)
  
$
(0.58
)
                                 
Weighted average number of shares outstanding, basic
    
20,104,547
      
16,923,695
      
18,728,372
      
16,912,583
  
                                 
Weighted average number of shares outstanding, diluted
    
20,104,547
      
16,923,695
      
18,728,372
      
16,912,583
  

See accompanying notes to condensed consolidated financial statements


CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
 
 
  
For the Three Months Ended
    
For the Nine Months Ended
  
 
  
September 30, 2020
    
September 30, 2019
    
September 30, 2020
    
September 30, 2019
  
Net loss
  
$
(5,538,798
)
  
$
(3,783,005
)
  
$
(18,382,144
)
  
$
(9,786,218
)
Other comprehensive income (loss):
                                
Foreign currency translation adjustments
    
262,094
      
(61,306
)
    
(776,645
)
    
(172,345
)
Comprehensive loss
  
$
(5,276,704
)
  
$
(3,844,311
)
  
$
(19,158,789
)
  
$
(9,958,563
)

See accompanying notes to condensed consolidated financial statements


CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)

  
For The Nine Months Ended September 30, 2020
  
   
Common Stock
    
Additional
Paid-in-
    
Treasury Stock
    
Accumulated
    
Accumulated Other
Comprehensive
        
   
Shares
    
Amount
    
Capital
    
Shares
    
Amount
    
Deficit
    
Income
    
Total
  
Balance at December 31, 2019
    
17,733,617
    
$
177,335
    
$
95,433,077
      
-
    
$
-
    
$
(71,585,003
)
  
$
9,844
    
$
24,035,253
  
                                                                 
Common Stock:
                                                                
Restricted stock issued
    
34,249
      
343
      
117,956
      
-
      
-
      
-
      
-
      
118,299
  
Restricted stock compensation, net 
    
(440,631
)
    
(4,406
)
    
(292,495
)
    
-
      
-
      
-
      
-
      
(296,901
)
Shares tendered for withholding taxes
    
-
      
-
      
145,056
      
(31,486
)
    
(145,056
)
    
-
      
-
      
-
  
                                                                 
Options:
                                                                
Stock option compensation
    
-
      
-
      
139,449
      
-
      
-
      
-
      
-
      
139,449
  
                                                                 
Comprehensive loss
    
-
      
-
      
-
      
-
      
-
      
-
      
(863,294
)
    
(863,294
)
                                                                 
Net loss
    
-
      
-
      
-
      
-
      
-
      
(4,999,549
)
    
-
      
(4,999,549
)
                                                                 
Balance at March 31, 2020
    
17,327,235
    
$
173,272
    
$
95,543,043
      
(31,486
)
  
$
(145,056
)
  
$
(76,584,552
)
  
$
(853,450
)
  
$
18,133,257
  
                                                                 
Common Stock:
                                                                
Issuance of stock, net
    
2,619,593
      
26,196
      
28,410,545
      
-
      
-
      
-
      
-
      
28,436,741
  
Restricted stock issued
    
18,858
      
189
      
(189
)
    
-
      
-
      
-
      
-
      
-
  
Restricted stock compensation, net
    
(29,543
)
    
(296
)
    
262,405
      
-
      
-
      
-
      
-
      
262,109
  
Shares tendered for withholding taxes
    
-
      
-
      
(192,161
)
    
(1,804
)
    
(5,863
)
    
-
      
-
      
(198,024
)
                                                                 
Options:
                                                                
Exercised
    
5,528
      
55
      
(55
)
    
-
      
-
      
-
      
-
      
-
  
Stock option compensation
    
-
      
-
      
122,115
      
-
      
-
      
-
      
-
      
122,115
  
                                                                 
Warrants exercised
    
253,161
      
2,532
      
(2,532
)
    
-
      
-
      
-
      
-
      
-
  
                                                                 
Comprehensive loss
    
-
      
-
      
-
      
-
      
-
      
-
      
(175,447
)
    
(175,447
)
                                                                 
Net loss
    
-
      
-
      
-
      
-
      
-
      
(7,843,797
)
    
-
      
(7,843,797
)
                                                                 
Balance at June 30, 2020
    
20,194,832
    
$
201,948
    
$
124,143,171
      
(33,290
)
  
$
(150,919
)
  
$
(84,428,349
)
  
$
(1,028,897
)
  
$
38,736,954
  
                                                                 
Common Stock:
                                                                
Restricted stock issued
    
19,124
      
191
      
105,561
      
-
      
-
      
-
      
-
      
105,752
  
Restricted stock compensation
    
-
      
-
      
275,985
      
-
      
-
      
-
      
-
      
275,985
  
                                                                 
Options:
                                                                
Stock option compensation
    
-
      
-
      
97,535
      
-
      
-
      
-
      
-
      
97,535
  
                                                                 
Comprehensive income
    
-
      
-
      
-
      
-
      
-
      
-
      
262,094
      
262,094
  
                                                                 
Net loss
    
-
      
-
      
-
      
-
      
-
      
(5,538,798
)
    
-
      
(5,538,798
)
                                                                 
Balance at September 30, 2020
    
20,213,956
    
$
202,139
    
$
124,622,252
      
(33,290
)
  
$
(150,919
)
  
$
(89,967,147
)
  
$
(766,803
)
  
$
33,939,522
  

See accompanying notes to condensed consolidated financial statements

CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)

  
For The Nine Months Ended September 30, 2019
  
   
Common Stock
    
Additional
Paid-in-Capital
    
Accumulated
Deficit
    
Accumulated Other
Comprehensive Income
    
Total
  
   
Shares
    
Amount
    
Amount
    
Amount
    
Amount
    
Amount
  
Balance at December 31, 2018
    
17,166,459
    
$
171,664
    
$
90,953,788
    
$
(57,909,874
)
  
$
112,196
    
$
33,327,774
  
                                                 
Common Stock:
                                                
Restricted stock compensation
    
-
      
-
      
281,248
      
-
      
-
      
281,248
  
                                                 
Options:
                                                
Stock option compensation
    
-
      
-
      
66,259
      
-
      
-
      
66,259
  
                                                 
Comprehensive loss
    
-
      
-
      
-
      
-
      
202,186
      
202,186
  
                                                 
Net loss
    
-
      
-
      
-
      
(2,816,533
)
    
-
      
(2,816,533
)
                                                 
Balance at March 31, 2019
    
17,166,459
    
$
171,664
    
$
91,301,295
    
$
(60,726,407
)
  
$
314,382
    
$
31,060,934
  
                                                 
Common Stock:
                                                
Restricted stock issued
    
375,000
      
3,750
      
(3,750
)
    
-
      
-
      
-
  
Restricted stock compensation
    
-
      
-
      
307,774
      
-
      
-
      
307,774
  
                                                 
Options:
                                                
Exercised
    
24,075
      
241
      
(241
)
    
-
      
-
      
-
  
Stock option compensation
    
-
      
-
      
69,097
      
-
      
-
      
69,097
  
                                                 
Comprehensive loss
    
-
      
-
      
-
      
-
      
(313,225
)
    
(313,225
)
                                                 
Net loss
    
-
      
-
      
-
      
(3,186,680
)
    
-
      
(3,186,680
)
                                                 
Balance at June 30, 2019
    
17,565,534
    
$
175,655
    
$
91,674,175
    
$
(63,913,087
)
  
$
1,157
    
$
27,937,900
  
                                                 
Common Stock:
                                                
Restricted stock compensation
    
-
      
-
      
440,396
      
-
      
-
      
440,396
  
                                                 
Options:
                                                
Stock option compensation
    
-
      
-
      
66,192
      
-
      
-
      
66,192
  
                                                 
Warrant on term debt
    
-
      
-
      
1,196,093
      
-
      
-
      
1,196,093
  
                                                 
Foreign currency translation adjustments
    
-
      
-
      
-
      
-
      
(61,306
)
    
(61,306
)
                                                 
Net loss
    
-
      
-
      
-
      
(3,783,005
)
    
-
      
(3,783,005
)
                                                 
Balance at September 30, 2019
    
17,565,534
    
$
175,655
    
$
93,376,856
    
$
(67,696,092
)
  
$
(60,149
)
  
$
25,796,270
  

See accompanying notes to condensed consolidated financial statements


CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE NINE MONTHS ENDED
(Unaudited)

  
September 30,2020
    
September 30, 2019
  
             
CASH FLOWS FROM OPERATING ACTIVITIES:
            
Cash received from customers and grants
  
$
26,122,815
    
$
29,423,872
  
Cash paid to suppliers and employees
    
(37,776,303
)
    
(35,185,776
)
Cash paid for operating leases
    
(797,482
)
    
(474,150
)
Cash paid for finance leases
    
(14,762
)
    
(4,033
)
Interest and taxes, net
    
(1,681,155
)
    
(158,120
)
Net cash used in operating activities
    
(14,146,887
)
    
(6,398,207
)
                 
CASH FLOWS FROM INVESTING ACTIVITIES:
                
Patent application costs
    
(181,417
)
    
(346,663
)
Acquisition of and deposits on fixed assets
    
(3,000,763
)
    
(2,568,244
)
Acquisitions
    
-
      
145,760
  
Net cash used in investing activities
    
(3,182,180
)
    
(2,769,147
)
                 
CASH FLOWS FROM FINANCING ACTIVITIES:
                
Issuance of stock, net
    
28,436,741
      
-
  
Proceeds from issuance of long-term debt, net
    
-
      
18,850,000
  
Stimulus package loan
    
2,978,315
      
-
  
Payment of stimulus package loan
    
(2,978,315
)
    
-
  
Payments of tax withholding on stock award
    
(348,944
)
    
-
  
Payments on debt issuance costs
    
-
      
(186,313
)
Payments on note payable
    
(180,249
)
    
(136,232
)
Payments on finance leases
    
(37,166
)
    
(9,851
)
Net cash provided by financing activities
    
27,870,382
      
18,517,604
  
                 
Effect of exchange rate changes on cash
    
(125,214
)
    
(6,909
)
INCREASE IN CASH AND CASH EQUIVALENTS
    
10,416,101
      
9,343,341
  
Cash and cash equivalents - beginning of the period
    
18,271,352
      
12,524,551
  
                 
Cash and cash equivalents - end of the period
  
$
28,687,453
    
$
21,867,892
  
                 
RECONCILIATION OF NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES:
                
                 
Net loss
  
$
(18,382,144
)
  
$
(9,786,218
)
Adjustments:
                
Depreciation and amortization
    
2,057,275
      
1,666,675
  
Benefit from deferred tax liability
    
(301,000
)
    
(402,639
)
Provision of doubtful accounts
    
214,210
      
-
  
Non-cash inventory changes
    
2,530,444
      
-
  
Share based compensation
    
824,345
      
1,230,966
  
Changes in assets and liabilities:
                
Accounts receivable
    
138,827
      
1,995,986
  
Inventories
    
(5,295,899
)
    
(558,122
)
Prepaid expenses and other current assets
    
(314,460
)
    
103,883
  
Deposits and other assets
    
80,873
      
(20,608
)
Accounts payable and accrued liabilities
    
559,888
      
(442,725
)
Deferred revenue
    
3,740,754
      
(185,405
)
Net cash used in operating activities
  
$
(14,146,887
)
  
$
(6,398,207
)
                 
Supplemental disclosures for non-cash investing and financing activities:
                
Deposits on manufacturing equipment transferred to fixed assets
  
$
472,651
    
$
430,000
  

See accompanying notes to condensed consolidated financial statements



CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2020
(Unaudited)

NOTE 1 — DESCRIPTION OF BUSINESS:

Chembio Diagnostics, Inc. (“Chembio”) and its subsidiaries (collectively with Chembio, the “Company”) develop and commercialize point-of-care rapid tests used for the detection and diagnosis of infectious diseases, including COVID-19, sexually transmitted disease, and fever and tropical disease. Coupled with the Company's extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease. Chembio’s products are sold globally, directly and through distributors, to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers under the Company’s DPP, STAT PAK, SURE CHECK and STAT-VIEW registered trademarks or under the private labels of the Company’s marketing partners.

The Company has been expanding its product portfolio based upon its proprietary DPP technology platform  that provides high-quality, rapid diagnostic results in 15 to 20 minutes using a small drop of blood from the fingertip or alternative samples. Through advanced multiplexing, the DPP platform can detect up to eight, distinct test results from a single patient sample, which can deliver greater clinical value than other rapid tests. For certain applications, Chembio’s easy-to-use, highly portable, battery-operated DPP Micro Reader optical analyzer then reports accurate results in approximately 15 seconds, making it well-suited for decentralized testing where real-time results enable patients to be clinically assessed while they are still on-site. Objective results produced by the DPP Micro Reader can reduce the possibility of the types of human error that can be experienced in the visual interpretations required by many rapid tests.

All DPP tests are developed and manufactured in the United States and are the subject of a range of domestic and global patents and patents pending.
 
During the nine months ended September 30, 2020, the Company refocused its business strategy on the development and commercialization of the DPP COVID-19 IgM/IgG System, which consists of a new serological test for COVID-19 and a Micro Reader analyzer. In the nine months ended September 30, 2020, the Company developed, received regulatory approval in the US, Brazil and Europe, and commercialized the DPP COVID-19 IgM/IgG System, which provided numerical readings for both IgM and IgG levels of antibodies to the virus, and began developing its strategy for a portfolio of products both related to and expanding beyond COVID-19. On June 16, 2020, the U.S. FDA Food and Drug Administration (the "FDA") revoked the Company’s Emergency Use Authorization ("EUA") for the DPP COVID-19 System in the U.S., and the Company immediately began developing a revised version. The Company submitted an application for EUA to the FDA for its new rapid antibody test system, DPP SARS-CoV-2 IgM/IgG on September 8, 2020.

On July 6, 2020, the Company received a $628,071 grant from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures ("BARDA") to assist the Company in developing a COVID-19 point-of-care antigen system using Chembio’s proprietary DPP technology and submitting an application for EUA to the FDA for the system. On October 15, 2020, Chembio submitted the EUA application for the DPP SARS-CoV-2 Antigen test system, which was designed to detect SARS-CoV-2 antigens in only 20 minutes. The DPP SARS-CoV-2 Antigen test system consists of a DPP SARS-CoV-2 Antigen test cartridge, a DPP Micro Reader optical analyzer and a minimally-invasive nasal swab.

In addition to its DPP COVID-19 rapid test products, the Company has a broad portfolio of infectious disease products, which it expects to generate a diminished amount of revenue for the foreseeable future both due to the impact of the global COVID-19 pandemic and while it focuses on the development, manufacture, and commercialization of DPP COVID-19 products. Through Research & Development (“R&D”) Services, the Company is developing tests in collaboration with Takeda Pharmaceutical Company Limited.

Large and growing markets have been established for these types of tests, initially in high prevalence regions where they are indispensable for large-scale prevention and treatment programs. More generally, the Company believes there is and will continue to be a growing demand for diagnostic products that can provide accurate, actionable diagnostic information in a rapid, cost-effective manner at the point of care.

Through R&D Services, the Company develops tests for third parties using its DPP platform and, in limited cases, other platforms in projects that the Company believes have the potential to create value for the rest of its business. In addition, the Company routinely enters into arrangements with governmental and non-governmental organizations for the funding of certain R&D efforts.

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, 2019, as filed with the SEC.

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

All adjustments contained in the accompanying unaudited condensed consolidated financial statements are of a normal recurring nature and are necessary to present fairly the financial position of the Company as of September 30, 2020. Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year.

(b)
Use of Estimates:

The preparation of the consolidated financial statements in conformity with GAAP requires management to make assumptions and estimates that affect the amounts reported in the accompanying unaudited condensed consolidated financial statements and these notes. Judgments and estimates of uncertainties are required in applying the Company’s accounting policies in certain areas. Generally, matters subject to estimation and judgment include accounts receivable realization, inventory, asset impairments, recognition of revenue including variable consideration and pursuant to milestones, useful lives of intangible and fixed assets, stock-based compensation, business combinations, and deferred tax asset valuation allowances. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be based upon amounts that differ from those estimates.

(c)
Fair Value of Financial Instruments:

The carrying values for cash and cash equivalents, accounts receivable, accounts payable, accrued expenses and other current liabilities approximate fair value due to the immediate or short-term maturity of these financial instruments. Included in cash and cash equivalents were $21.0 million and $16.0 million as of September 30, 2020 and December 31, 2019, respectively, of money market funds that are Level 1 fair value measurements under the hierarchy. The fair value of the Company’s total debt of $20.0 million (carrying value of $18.0 million) and $20.0 million (carrying value of $17.6 million) as of September 30, 2020 and December 31, 2019, respectively, is a Level 2 fair value measurement under the hierarchy, and the carrying value approximates fair value.

Fair value measurements of all financial assets and liabilities that are 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, and include restricted cash of $2.3 million and $0 as of September 30, 2020 and December 31, 2019, respectively.

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

(e)
Concentrations of Credit Risk:

Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of temporary cash investments and trade receivables. The Company places its temporary cash instruments with well-known financial institutions and, at times, may maintain balances in excess of the Federal Deposit Insurance Corporation insurance limit. The Company monitors the credit ratings of the financial institutions to mitigate this risk. Concentration of credit risk with respect to trade receivables is principally mitigated by the Company’s ability to obtain letters of credit from certain foreign customers and its diverse customer base, both in number of customers and geographic locations.

(f)
Fixed Assets:

Fixed assets are stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets, which range from three to seven years. Leasehold improvements are amortized over the useful life of the asset or the lease term, whichever is shorter. Deposits paid for fixed assets are capitalized and not depreciated until the related asset is placed in service.

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

Long-lived assets to be held and used are analyzed for impairment whenever events or changes in circumstances indicate that the related carrying amounts may not be recoverable. The Company evaluates at each balance sheet date whether events and circumstances have occurred that indicate possible impairment. If there are indications of impairment, the Company uses future undiscounted cash flows of the related asset or asset grouping over the remaining life in measuring whether the assets are recoverable. In the event such cash flows are not expected to be sufficient to recover the recorded asset values, the assets are written down to their estimated fair value. No impairment of long-lived tangible and intangible assets was recorded for the nine months ended September 30, 2020 or 2019.

(h)
Revenue Recognition:

The Company recognizes revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. The Company recognizes revenue following the five-step model prescribed under Accounting Standards Update (“ASU”) 2014-09: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligation.

Product Revenue

Revenues from product sales are recognized and commissions are accrued when the customer obtains control of the Company’s product, which occurs at a point in time, typically upon tendering the product to the customer. The Company expenses incremental costs of obtaining a contract as and when incurred because the expected amortization period of the asset that it would have recognized is one year or less or the amount is immaterial. Freight and distribution activities on products are performed after the customer obtains control of the goods. The Company has made an accounting policy election to account for shipping and handling activities that occur either when or after goods are tendered to the customer as a fulfillment activity, and therefore recognizes freight and distribution expenses in cost of product sales. The Company excludes certain taxes from the transaction price (e.g., sales, value added and some excise taxes).

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

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

The Company’s payment terms vary by the type and location of the Company’s customer and products or services offered. Payment terms differ by jurisdiction and customer, but payment is generally required in a term ranging from 30 to 60 days from date of shipment or satisfaction of the performance obligation.

Reserves for Discounts and Allowances

Revenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with the Company’s customers. The Company’s process for estimating reserves established for these variable consideration components does not differ materially from its historical practices.

Product revenue reserves, which are classified as a reduction in product revenues, are generally related to discounts and returns. Estimates of variable consideration and the determination of whether to include estimated amounts in the transaction price are based on all information (historical, current, and forecasted) that is reasonably available to the Company, taking into consideration the type of customer, the type of transaction, market events and trends, and the specific facts and circumstances of each arrangement. The transaction price, which includes variable consideration reflecting the impact of discounts, allowances and returns may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from the Company’s estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on revenue and earnings in the period of adjustment.

License and Royalty Revenue

The Company receives royalty revenue on sales by its licensee of products covered under patents that the Company owns. The Company does not have future performance obligations under this license arrangement. The Company records revenue based on estimates of the sales that occurred during the relevant period as a component of license and royalty revenue. The relevant period estimates of sales are based on interim data provided by the licensee and analysis of historical royalties that have been paid to the Company, adjusted for any changes in facts and circumstances, as appropriate. Differences between actual and estimated royalty revenue are adjusted for in the period in which they become known, typically the following quarter. Historically, adjustments have not been material when compared to actual amounts paid by licensees.

R&D and Grant Revenue

All contracts with customers are evaluated under the five-step model described above. For certain contracts that represent grants where the funder does not meet the definition of a customer, the Company recognizes revenue when earned in accordance with Accounting Standards Codification (“ASC”) Topic 958. Such contracts are further described under Disaggregation of Revenue below. Grants are invoiced and revenue is recognized ratably as that is the depiction of the timing of the transfer of services. The R&D study, which encompasses various phases of product development processes: design feasibility & planning, product development and design optimization, design verification, design validation and process validation, and pivotal studies, is also recognized ratably.

In June 2018, the Financial Accounting Standards Board (the “FASB”) issued ASU 2018-08, Not-for-Profit Entities (Topic 958): Clarifying the Scope and the Accounting Guidance for Contributions Received and Contributions Made. This ASU clarifies the guidance presented in ASC Topic 958, “Not-for-Profit Entities,” for evaluating whether a transaction is reciprocal (i.e., an exchange transaction) or nonreciprocal (i.e., a contribution) and for distinguishing between conditional and unconditional contributions. The ASU also clarified the guidance used by entities other than not-for-profits to identify and account for contributions made.

Disaggregation of Revenue

The following table disaggregates total revenues:

  
For the Three Months Ended
  
   
September 30, 2020
    
September 30, 2019
  
   
Exchange
Transactions
    
Non-Exchange
Transactions
    
Total
    
Exchange
Transactions
    
Non-Exchange
Transactions
    
Total
  
Net product sales
  
$
8,406,457
    
$
-
    
$
8,406,457
    
$
8,510,629
    
$
-
    
$
8,510,629
  
R&D and grant revenue
    
1,444,724
      
209,776
      
1,654,500
      
880,458
      
91,522
      
971,980
  
License and royalty revenue
    
211,521
      
-
      
211,521
      
238,330
      
-
      
238,330
  
   
$
10,062,702
    
$
209,776
    
$
10,272,478
    
$
9,629,417
    
$
91,522
    
$
9,720,939
  

 
For the Nine Months Ended
  
   
September 30, 2020
    
September 30, 2019
  
   
Exchange
Transactions
    
Non-Exchange
Transactions
    
Total
    
Exchange
Transactions
    
Non-Exchange
Transactions
    
Total
  
Net product sales
  
$
17,914,623
    
$
-
    
$
17,914,623
    
$
23,381,906
    
$
-
    
$
23,381,906
  
R&D and grant revenue
    
3,546,385
      
209,776
      
3,756,161
      
2,272,454
      
1,255,579
      
3,528,033
  
License and royalty revenue
    
572,450
      
-
      
572,450
      
703,352
      
-
      
703,352
  
   
$
22,033,458
    
$
209,776
    
$
22,243,234
    
$
26,357,712
    
$
1,255,579
    
$
27,613,291
  

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

The following table disaggregates revenues by geographic location of the customer:

 
  
For the Three Months Ended
    
For the Nine Months Ended
  
 
  
September 30, 2020
    
September 30, 2019
    
September 30, 2020
    
September 30, 2019
  
Africa
  
$
1,874,518
    
$
1,250,063
    
$
3,310,603
    
$
6,009,103
  
Asia
    
168,052
      
505,379
      
650,659
      
746,025
  
Europe & Middle East
    
2,887,209
      
1,629,965
      
6,698,382
      
4,880,744
  
Latin America
    
4,618,560
      
4,296,903
      
7,515,523
      
9,981,874
  
United States
    
724,139
      
2,038,629
      
4,068,067
      
5,995,545
  
   
$
10,272,478
    
$
9,720,939
    
$
22,243,234
    
$
27,613,291
  

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 September 30, 2020, the Company reported $3,865,754 in deferred revenue, of which $2.0 million is expected to be recognized during the three months ending December 31, 2020, and the remainder over the next 12 months.

(i)
Inventories:

Inventories consisted of the following at:

 
  
September 30, 2020
    
December 31, 2019
  
Raw materials
  
$
6,633,884
    
$
2,901,319
  
Work in process
    
2,180,108
      
793,343
  
Finished goods
    
3,549,494
      
5,903,368
  
 
  
$
12,363,486
    
$
9,598,030
  

(j)
Loss Per Share:

Basic loss per share is computed by dividing net loss attributable to holders of Chembio’s common stock (“common stock”) by the weighted-average number of shares of common stock outstanding for the period excluding unvested restricted stock. Diluted loss per share for the nine months ended September 30, 2020 and 2019 reflected the potential dilution from the exercise or conversion of other securities into common stock, if dilutive.

There were 634,851 and 650,093 restricted shares awards outstanding as of September 30, 2020 and 2019, respectively, that were not included in the calculation of diluted income per share for the three and nine months ended September 30, 2020 and 2019, because their effect would have been anti-dilutive. There were 950,997 and 672,472 weighted-average options outstanding as of September 30, 2020 and 2019, respectively, that were not included in the calculation of diluted income per share for the three and nine months ended September 30, 2020 and 2019, respectively, because their effect would have been anti-dilutive.

(k)
Research and Development:

R&D costs are expensed as incurred. Advance payments for goods and services that will be used in future R&D activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.

(l)
Equity Plans:

Effective June 3, 2008, Chembio’s stockholders voted to approve the 2008 Stock Incentive Plan (the “SIP”), 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 SIP by 125,000 to 750,000. Under the terms of the SIP, which expired during 2018, the Board of Directors of Chembio (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 September 30, 2020, there were 694,000 options expired, forfeited or exercised, and at September 30, 2020, 56,000 options were outstanding. No Equity Award Units are available to be issued under the SIP.

Effective June 19, 2014, Chembio’s stockholders voted to approve the 2014 Stock Incentive Plan (the “SIP14”), with 800,000 shares of common stock available to be issued. Under the terms of the SIP14, the Board or its Compensation Committee has the discretion to select the persons to whom awards are to be granted. Awards can be in the form of Equity Award Units. The awards vest at such times and under such conditions as determined by the Board or its Compensation Committee. Cumulatively through September 30, 2020, there were 479,375 Equity Award Units expired, forfeited or exercised. At September 30, 2020, 299,564 Equity Award Units were outstanding, and 0 Equity Award Units are available to be issued under the SIP14. Following the approval of the 2019 Plan (defined below), any Equity Award Units outstanding under the SIP14 remain subject to and be paid under the SIP14, and any shares subject to outstanding awards under the SIP14 that expire, terminate, or are surrendered or forfeited for any reason without issuance of shares automatically become available for issuance under the 2019 Plan.

Effective June 18, 2019, 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. 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, are available for the grant of new awards under the 2019 Plan. Under the terms of the 2019 Plan, the Board or its Compensation Committee has the discretion to select the persons to whom awards are to be granted. Awards can be in the form of options, stock appreciation rights, restricted stock, restricted stock units, or other stock-based awards under the 2019 Plan (collectively, “2019 Equity Units”). The 2019 Equity Units become vested at such times and under such conditions as determined by the Board or its Compensation Committee. Cumulatively through September 30, 2020, 489,294 2019 Equity Units has been exercised or forfeited. At September 30, 2020, 1,230,286 2019 Equity Units were outstanding, and 1,311,096 2019 Equity Units were available to be awarded under the 2019 Plan.

(m)
Stock-Based Compensation:

The fair value of restricted stock and performance/restricted stock unit awards are determined on the date of grant or the date of issuance, as applicable. Stock-based compensation expense for stock options is calculated using the Black-Scholes valuation model. Stock based compensation is reduced for actual forfeitures in the period in which the forfeiture occurs and generally recognized on a straight-line basis over the service period of the grant. During the three and nine months ended September 30, 2020, 16,314 and 486,488 shares of restricted stock were forfeited, respectively. During the three and nine months ended September 30, 2020, 83,127 and 123,127 options were forfeited, respectively.

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

 
  
For the Three Months Ended
September 30,
    
For the Nine Months Ended
September 30,
  
 
  
2020
    
2019
    
2020
    
2019
  
Cost of product sales
  
$
-
    
$
2,691
    
$
6,300
    
$
8,479
  
Research and development expenses
    
126,333
      
56,251
      
281,070
      
172,346
  
Selling, general and administrative expenses
    
350,871
      
447,646
      
960,959
      
1,050,141
  
Severance and related costs
    
-
      
-
      
(423,984
)
    
-
  
   
$
477,204
    
$
506,588
    
$
824,345
    
$
1,230,966
  

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

  
For the Nine Months Ended September 30, 2020
  
Expected term (in years)
    
6.3
  
Expected volatility
    
45.37
%
Expected dividend yield
    
0.00
%
Risk-free interest rate
    
1.33
%

The following table provides stock option activity for the nine months ended September 30, 2020:

Stock Options
  
Number of
Shares
  
Weighted
 Average
 Exercise Price
 per Share
  
Weighted
 Average
Remaining
Contract
Term
  
Aggregate
Intrinsic
Value
Outstanding at December 31, 2019
  
642,625
  
$
5.79
  
3 years
  
$
285,925
                     
Granted
  
702,499
    
2.50
        
-
Exercised
  
(36,000)
    
6.30
        
95,976
Forfeited/expired/cancelled
  
(358,127)
    
2.44
        
-
Outstanding at September 30, 2020
  
950,997
  
$
4.09
  
5 years
  
$
-
Exercisable at September 30, 2020
  
205,583
  
$
7.59
  
3 years
  
$
-

The following table summarizes information about stock options outstanding at September 30, 2020:

  
Stock Options Outstanding
  
Stock Options Exercisable
Range of Exercise Prices
  
Number of
Shares
  
Average
Remaining
Contract Term
(Years)
  
Weighted
Average
Exercise
Price
  
Aggregate
Intrinsic
Value
  
Number of
Shares
  
Weighted
Average
Exercise
Price
  
Aggregate
Intrinsic
Value
$1 to $2.79999
  
636,364
  
6.46
  
$
2.36
  
$
-
  
-
  
$
-
  
$
-
$2.8 to $4.59999
  
-
  
-
    
-
    
-
  
-
    
-
    
-
$4.6 to $6.39999
  
59,883
  
3.42
    
5.56
    
-
  
30,000
    
5.51
    
-
$6.4 to $8.19999
  
207,875
  
3.30
    
7.31
    
-
  
147,458
    
7.28
    
-
$8.2 to $12
  
46,875
  
2.85
    
11.45
    
-
  
28,125
    
11.45
    
-
 Total
  
950,997
  
5.40
  
$
4.09
  
$
-
  
205,583
  
$
7.59
  
$
-

As of September 30, 2020, there was $775,947 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 2.35 years. The total fair value of shares vested during the nine months ended September 30, 2020 and 2019 was $172,145 and $295,412, respectively.

The following table summarizes information about restricted stock, restricted stock units and performance stock units outstanding as of September 30, 2020:

  
Number of
Shares & Units
    
Weighted-
Average
Grant Date
Fair Value
  
Outstanding at December 31, 2019
    
545,986
    
$
7.47
  
                 
Granted
    
642,081
      
2.68
  
Vested
    
(66,728
)
    
3.62
  
Forfeited/expired/cancelled
    
(486,488
)
    
6.43
  
Outstanding at September 30, 2020
    
634,851
    
$
3.43
  

As of September 30, 2020, there was $1,391,802 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 1.94 years.

(n)
Geographic Information and Economic Dependency

The Company produces only one group of similar products known collectively as “rapid medical tests,” and it operates in a single operating segment. Net product revenue by geographic area was as follows:

 
  
For the Three Months Ended
September 30,
    
For the Nine Months Ended
September 30,
  
 
  
2020
    
2019
    
2020
    
2019
  
Africa
  
$
1,874,518
    
$
1,250,063
    
$
3,310,603
    
$
6,009,103
  
Asia
    
168,052
      
505,379
      
650,659
      
746,025
  
Europe & Middle East
    
1,451,486
      
1,027,147
      
3,360,648
      
2,946,813
  
Latin America
    
4,618,560
      
4,296,904
      
7,515,523
      
9,981,874
  
United States
    
293,841
      
1,431,136
      
3,077,190
      
3,698,091
  
   
$
8,406,457
    
$
8,510,629
    
$
17,914,623
    
$
23,381,906
  

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

 
  
September 30, 2020
    
December 31, 2019
  
Asia
  
$
342,485
    
$
393,299
  
Europe & Middle East
    
161,173
      
165,029
  
Latin America
    
12,512
      
60,527
  
United States
    
7,516,942
      
5,314,714
  
 
  
$
8,033,112
    
$
5,933,569
  

(o)
Accounts Payable and Accrued Liabilities:

Accounts payable and accrued liabilities consisted of:

 
  
September 30, 2020
    
December 31, 2019
  
Accounts payable – suppliers
  
$
3,586,917
    
$
3,144,098
  
Accrued commissions and royalties
    
511,110
      
931,760
  
Accrued payroll
    
274,218
      
231,753
  
Accrued vacation
    
488,002
      
410,199
  
Accrued bonuses
    
575,479
      
215,000
  
Accrued severance
    
145,096
      
-
  
Accrued expenses – other
    
977,960
      
593,433
  
TOTAL
  
$
6,558,782
    
$
5,526,243
  

(p)
Goodwill, Long-Lived Assets and Intangible Assets:

The following table reflects changes in goodwill:

Beginning balance at December 31, 2019
  
$
5,872,690
  
Change in foreign currency exchange rate
    
(176,011
)
Balance at September 30, 2020
  
$
5,696,679
  

Intangible assets consisted of the following:

  
September 30, 2020
  
December 31, 2019
   
Weighted
Average
Remaining
Useful Life
  
Cost
  
Accumulated
Amortization
  
Net Book
Value
  
Cost
  
Accumulated
Amortization
  
Net Book
Value
Intellectual property
  
5
  
$
1,586,043
  
$
420,818
  
$
1,165,225
  
$
1,418,681
  
$
299,232
  
$
1,119,449
Developed technology
  
5
    
2,009,962
    
487,637
    
1,522,325
    
1,922,682
    
266,550
    
1,656,132
Customer contracts/relationships
  
7
    
1,270,152
    
380,277
    
889,875
    
1,325,521
    
270,902
    
1,054,619
Trade names
  
7
    
111,568
    
40,498
    
71,070
    
114,946
    
30,794
    
84,152
       
$
4,977,725
  
$
1,329,230
  
$
3,648,495
  
$
4,781,830
  
$
867,478
  
$
3,914,352

Intellectual property, developed technology, customer contracts/relationships and trade names are amortized over 10, 7, 10, and 11 years, respectively. Amortization expense for the nine months ended September 30, 2020 and 2019 was $149,222 and $378,691, respectively. Amortization expense, subject to changes in currency exchange rates, is expected to be approximately $598,000 per year from 2020 through 2024, and total $1,107,056 for all remaining years combined.

(q)
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 nine months ended September 30, 2020 was 1.9% and 1.7%, compared to the effective tax rate of 0.5% and 3.9% for the three and nine months ended September 30, 2019. 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.

(r)
Allowance for Doubtful Accounts:

The Company records allowances for doubtful accounts for the estimated probable losses on uncollectible accounts receivable. The allowance is based upon the credit worthiness of the Company’s customers, the Company’s historical experience, the age of the receivable and current market and economic conditions. Receivables are written off against these allowances in the period they are determined to be uncollectible.

(s)
Foreign Currency Translation:

The functional currency of a foreign subsidiary is the local currency. Assets and liabilities of foreign subsidiaries that use a currency other than U.S. dollars as their functional currency are translated to U.S. dollars at end of period currency exchange rates. The consolidated statements of operations of foreign subsidiaries are translated to U.S. dollars at average period currency exchange rates. The effect of translation for foreign subsidiaries is generally reported in other comprehensive (loss) income. Foreign transaction gains and losses have been immaterial.

(t)
Acquisition Costs:

Acquisition costs include period expenses, primarily professional services, related to acquisition activities. For the nine months ended September 30, 2020 and 2019, the Company recognized $63,497 and $395,612 in acquisition costs related to its acquisition of Orangelife Comercio e Industria Ltda. ("Orangelife") and opTricon GmbH, respectively.

(u)
Recently Issued Accounting Standards:

Recently Adopted

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

In June 2016, the FASB issued ASU 2016-13. ASU 2016-13 provides guidance on measurement of credit losses on financial instruments that changes the impairment model for most financial assets and certain other instruments, including trade and other receivables, held-to-maturity debt securities and loans, and that requires entities to use a new, forward-looking “expected loss” model that is expected to generally result in the earlier recognition of allowances for losses. The guidance became effective for annual periods beginning after December 15, 2019, including interim periods within those years. The Company has evaluated the effects of this standard and determined that the adoption did not have a material impact on the Company’s consolidated financial statements.

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

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

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

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

Not Yet Adopted

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

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

ASU 2019-12, Simplifications to Accounting for Income Taxes (“ASU 2019-12”)

In December 2019, the FASB issued ASU 2019-12. ASU 2019-12 removes certain exceptions for recognizing deferred taxes for investments, performing intra-period allocation and calculating income taxes in interim periods. The ASU also adds guidance to reduce complexity in certain areas, including deferred taxes for goodwill and allocating taxes for members of a consolidated group. ASU 2019-12 is effective for all entities for fiscal years beginning after December 15, 2020, and earlier adoption is permitted. The Company is currently evaluating the impact of adopting ASU 2019-12 on its consolidated financial statements.

(w)
Severance, restructuring and other related costs:

During the nine months ended September 30, 2020, the Company recognized $0.7 million in net severance expenses related to the departure of Chembio’s former chief executive officer and the elimination of certain positions as part of its multi-faceted expense reduction program to reduce operating expenses. The Company undertook actions to adjust the size and composition of the organization, including by removing positions that were non-essential in light of its new business strategy, and to remove other expenses, all of which the Company expects will provide savings throughout, and after, 2020.

In light of market dynamics, the Company retrenched its Malaysian operations, including the termination of employment of its Malaysian workforce. The Company will maintain its Malaysian subsidiary and sustain the product registrations that were obtained throughout southeast Asia, with the benefit of having that entity and the WHO prequalification certified facility.

Based on these activities, the Company took restructuring actions totaling $0.4 million to realign and resize its production capacity and cost structure. All expenses have been paid as of September 30, 2020.

NOTE 3 – ACQUISITION:

Orangelife

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

●
$150,000 in cash and 153,707 shares of common stock.
●
Issuance of 316,456 shares of common stock to the founder and former chief executive officer of Orangelife, based on the transfer and approval of registration of certain of the Company’s products in Brazil prior to November 25, 2022. All of the shares may be deliverable in the event of change in control of Chembio. The number of shares issued was subject to adjustments based upon Orangelife’s working capital at closing. The fair value of the shares on the date of the acquisition was recorded in equity and was valued at $1.2 million.

The acquisition of Orangelife allowed the Company to expand its commercial presence by offering its products to the state, private and pharmacy markets in Brazil, in addition to providing local support to its long-time customer Bio-Manguinhos, a subsidiary of the Oswaldo Cruz Foundation (Fiocruz), which oversees development and production of vaccines, diagnostics, and biopharmaceuticals to meet the demands of Brazil’s national public health system. The results of Orangelife’s operations have been reflected in the consolidated financial statements since November 25, 2019.

The acquisition was accounted for using the purchase method of accounting. The following table summarizes the allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed on the closing date of November 25, 2019:

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

The Company calculated the estimated fair value of the fixed assets based on the net book value of Orangelife, which approximated fair value. The estimated fair value of the trade name, customer contracts/relationships and contingent earnouts were based on discounted cash flows using management estimates.

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

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

  
Unaudited
Pro Forma
December 31, 2019
  
Total revenues
  
$
35,157,248
  
Net loss
  
$
(13,654,001
)
Net loss per common share
  
$
(0.80
)
Diluted net loss per common share
  
$
(0.80
)


NOTE 4 – COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS:

(a)
Concentrations:

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

  
For the Three Months Ended
    
For the Nine Months Ended
    
Accounts Receivable as of
  
   
September 30, 2020
    
September 30, 2019
    
September 30, 2020
    
September 30, 2019
    
September 30, 2020
    
Dec. 31, 2019
  
   
Sales
    
% of Sales
    
Sales
    
% of Sales
    
Sales
    
% of Sales
    
Sales
    
% of Sales
              
Customer 1
  
$
4,226,040
      
50.3
%
  
$
3,966,142
      
46.6
%
  
$
6,523,416
      
36.4
%
  
$
10,012,644
      
42.8
%
  
$
1,622,866
    
$
941,962
  
Customer 2
  
$
1,071,513
      
12.7
%
  
$
-
      
-
    
$
-
      
-
    
$
-
      
-
    
$
-
    
$