☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
|
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Nevada
|
|
88-0425691
|
(State or other jurisdiction of incorporation)
|
|
(IRS Employer Identification Number)
|
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
|
|
Large accelerated filer ☐
|
Accelerated filer ☒
|
|
Non-accelerated filer ☐
|
Smaller reporting company ☒
|
|
Emerging growth company ☐
|
|
Page
|
|
Part I. FINANCIAL INFORMATION:
|
||
4
|
||
5
|
||
6
|
||
7
|
||
9
|
||
10
|
||
25
|
||
34
|
||
Part II. OTHER INFORMATION:
|
||
34
|
||
34
|
||
39
|
||
40
|
|
For the three months ended
|
For the six months ended
|
||||||||||||||
June 30, 2021
|
June 30, 2020
|
June 30, 2021
|
June 30, 2020
|
|||||||||||||
REVENUES:
|
||||||||||||||||
Net product sales
|
$
|
3,931,383
|
$
|
3,791,574
|
$
|
7,956,045
|
$
|
9,508,166
|
||||||||
R&D revenue
|
727
|
1,193,973
|
1,107,366
|
2,101,660
|
||||||||||||
Government grant income
|
2,280,000
|
-
|
5,630,000
|
-
|
||||||||||||
License and royalty revenue
|
250,000
|
125,625
|
493,058
|
360,929
|
||||||||||||
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
|
-
|
-
|
-
|
63,497
|
||||||||||||
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 and diluted loss per share
|
$
|
(0.45
|
)
|
$
|
(0.42
|
)
|
$
|
(0.67
|
)
|
$
|
(0.71
|
)
|
||||
Weighted average number of shares outstanding, basic and diluted
|
20,219,617
|
18,868,144
|
20,191,657
|
18,032,723
|
|
For the three months ended
|
For the six months ended
|
||||||||||||||
|
June 30, 2021
|
June 30, 2020
|
June 30, 2021
|
June 30, 2020
|
||||||||||||
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
|
)
|
|
For the six months ended June 30, 2021
|
|||||||||||||||||||||||||||||||
Common Stock
|
Additional
Paid-in-Capital |
Treasury
Stock
|
Accumulated
Deficit
|
AOCI
|
Total
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
|||||||||||||||||||||||||||||
Balance at December 31, 2020
|
20,223,498
|
$
|
202,235
|
$
|
124,961,514
|
(41,141
|
)
|
$
|
(190,093
|
)
|
$
|
(97,106,331
|
)
|
$
|
(90,916
|
)
|
$
|
27,776,409
|
||||||||||||||
Common Stock:
|
||||||||||||||||||||||||||||||||
Restricted stock issued
|
62,197
|
622
|
58,909
|
-
|
-
|
-
|
-
|
59,531
|
||||||||||||||||||||||||
Restricted stock compensation, net
|
-
|
-
|
309,010
|
-
|
-
|
-
|
-
|
309,010
|
||||||||||||||||||||||||
Shares tendered for withholding taxes
|
-
|
-
|
(115,059
|
)
|
-
|
-
|
-
|
-
|
(115,059
|
)
|
||||||||||||||||||||||
Options:
|
||||||||||||||||||||||||||||||||
Stock option compensation
|
-
|
-
|
211,140
|
-
|
-
|
-
|
-
|
211,140
|
||||||||||||||||||||||||
Comprehensive loss
|
-
|
-
|
-
|
-
|
-
|
-
|
(455,722
|
)
|
(455,722
|
)
|
||||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
-
|
(4,500,163
|
)
|
-
|
(4,500,163
|
)
|
||||||||||||||||||||||
Balance at March 31, 2021
|
20,285,695
|
$
|
202,857
|
$
|
125,425,514
|
(41,141
|
)
|
$
|
(190,093
|
)
|
$
|
(101,606,494
|
)
|
$
|
(546,638
|
)
|
$
|
23,285,146
|
||||||||||||||
Common Stock:
|
||||||||||||||||||||||||||||||||
Restricted stock issued
|
51,677
|
517
|
(517
|
)
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||||||||
Restricted stock compensation, net
|
-
|
-
|
288,053
|
-
|
-
|
-
|
-
|
288,053
|
||||||||||||||||||||||||
Shares tendered for withholding taxes
|
-
|
-
|
(4,454
|
)
|
-
|
-
|
-
|
-
|
(4,454
|
)
|
||||||||||||||||||||||
Options:
|
||||||||||||||||||||||||||||||||
Stock option compensation
|
-
|
-
|
297,791
|
-
|
-
|
-
|
-
|
297,791
|
||||||||||||||||||||||||
Comprehensive loss
|
-
|
-
|
-
|
-
|
-
|
-
|
301,102
|
301,102
|
||||||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
-
|
(9,064,385
|
)
|
-
|
(9,064,385
|
)
|
||||||||||||||||||||||
Balance at June 30, 2021
|
20,337,372
|
$
|
203,374
|
$
|
126,006,387
|
(41,141
|
)
|
$
|
(190,093
|
)
|
$
|
(110,670,879
|
)
|
$
|
(245,536
|
)
|
$
|
15,103,253
|
|
For the six months ended June 30, 2020
|
|||||||||||||||||||||||||||||||
Common Stock
|
Additional
Paid-in-Capital |
Treasury Stock
|
Accumulated
Deficit
|
AOCI
|
Total
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
|||||||||||||||||||||||||||||
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
|
(a) |
Basis of Presentation:
|
•
|
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.
|
(b) |
Significant Accounting Policies:
|
(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).
|
(d) |
Cash and Cash Equivalents:
|
(e) |
Loss Per Share:
|
(f) |
Income Taxes:
|
(g) |
Recently Issued Accounting Standards Affecting the Company:
|
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
|
|
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
|
|
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
|
(a) |
Common Stock
|
(b) |
Preferred Stock
|
(c) |
Treasury Stock
|
(d) |
Options, Restricted Stock, and Restricted Stock Units
|
(a) |
Concentrations:
|
|
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
|
(b) |
Governmental Regulation:
|
(c) |
Employment Contracts:
|
(d) |
Benefit Plan:
|
(e) |
Leases:
|
|
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
|
|
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
|
|
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
|
%
|
|
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:
|
• |
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.
|
(a) |
Equity Plans:
|
(b) |
Stock Compensation Expense:
|
|
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
|
|
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 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
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
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
|
|
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
|
|
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
|
•
|
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.
|
ITEM 2. |
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
• |
an emergency use authorization, or EUA, from the U.S. Food and Drug Administration, or FDA, as well as 510(k) clearance from the FDA, for the DPP SARS-CoV-2 Antigen test system;
|
• |
an EUA from the FDA for the DPP Respiratory Panel; and
|
• |
a Clinical Laboratory Improvement Amendment, or CLIA, waiver from the FDA for the DPP HIV-Syphilis test system.
|
• |
DPP SARS-CoV-2 Antigen Test System. As we described under “Item 8.01. Other Matters—Business—COVID-19 Antigen Test System—Commercialization” in the July 19 Form 8-K, throughout 2021 we have been actively pursuing sales opportunities for the DPP SARS-CoV-2 Antigen test system with governmental agencies, non-governmental organizations and distributors in countries where the test system is approved and registered. While we believed there continued to be opportunities for business awards in countries where the DPP SARS-CoV-2 Antigen test system is approved and registered, those business awards, including the issuance of purchase orders, had been repeatedly delayed for various reasons, including the impact of periodic COVID-19 lockdowns affecting product registrations and purchasing organization processes. On July 20, 2021, we 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. Bio-Manguinhos, a subsidiary of the Oswaldo Cruz Foundation (known as Fiocruz), is responsible for the development and production of vaccines, diagnostics, and biopharmaceuticals, primarily to meet demands of Brazil’s national public health system. We have a long-standing relationship with Bio-Manguinhos, having supplied multiple products for point-of-care detection of COVID-19 antibodies, HIV and other infectious diseases. Bio-Manguinhos received regulatory approval from Agência Nacional de Vigilância Sanitária, or ANVISA, in March 2021, following ANVISA approval of the DPP SARS-CoV-2 Antigen test system for our Brazilian subsidiary in November 2020. We are taking advantage of investments we made earlier this year in inventory for DPP SARS-CoV-2 Antigen tests in order to provide an initial number of the tests deliverable under the Bio-Manguinhos purchase order.
|
• |
HIV 1/2 STAT-PAK Assay. On July 22, 2021, we 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.
|
•
|
retain the employment of those employees in the light of our liquidity challenges and a highly competitive employment market stemming, in part, from the COVID-19 pandemic (see “—Substantial Doubt as to Going Concern Status” above, “—Liquidity and Capital Resources” below, and “Because of our liquidity limitations, we have concluded there is a substantial doubt about our ability to continue as a going concern and we may require additional capital to fund our operations, which capital may not be available to us on acceptable terms or at all” and “Because of our liquidity and operational limitations, including the availability of staffing and supply chain resources that are necessary but outside of our control, we may not be able to fulfill all of the requirements of customer purchase orders received in July 2021 without additional capital to fund our operations, which capital may not be available to us on acceptable terms, or at all” in “Item 1A. Risk Factors” of Part II of this report);
|
•
|
optimize our potential to deliver tests in accordance with the two significant customer purchase orders received in July 2021, as described under “—Recent Events—Customer Purchase Orders”; and
|
•
|
position our company on a solid path for the future.
|
•
|
20%, or up to $180,000, would be payable to OTIP participants following our receipt of payment for the initial delivery of tests under either order;
|
•
|
30%, or up to $270,000, would be payable to OTIP participants following our receipt of payments under the orders totaling approximately $16.2 million (one-half of the aggregate purchase prices of the two orders); and
|
•
|
50%, or up to $450,000, would be payable to OTIP participants upon our receipt of payment for the total purchase prices of the two orders.
|
• |
We recorded an impairment loss of $1.3 million for the three months ended June 30, 2021 as the result of our write-off of the intangible assets, net, leasehold improvements, net and right-of-use assets for leases, net associated with our Malaysian operations that underwent a retrenchment during the three months ended June 30, 2020. During the three months ended June 30, 2021, we were informed that WHO had prioritized its review of prequalification of the manufacture of our HIV 1/2 STAT-PAK Assay on our U.S. automated manufacturing processes, which would reduce our reliance on manual labor that otherwise could have been performed at our Malaysian facilities had we re-started operations there. During July 2021, WHO approved the change notification. The products produced on our 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, including the timing and mix of products to be delivered pursuant to the customer purchase orders described above under “—Customer Purchase Orders.” See note 12 to the Accompanying Financial Statements.
|
• |
We incurred a loss of $0.9 million for the three months ended June 30, 2021 related to the write-down of inventory for products that were not salable based on our periodic review of the current status and future benefits of inventory.
|
For the three months ended June 30,
|
||||||||||||||||
|
2021
|
2020
|
||||||||||||||
|
||||||||||||||||
TOTAL REVENUES
|
$
|
6,462
|
100
|
%
|
$
|
5,111
|
100
|
%
|
||||||||
|
||||||||||||||||
OPERATING COSTS AND EXPENSES:
|
||||||||||||||||
Cost of product sales
|
4,040
|
63
|
%
|
5,671
|
111
|
%
|
||||||||||
Research and development expenses
|
2,797
|
43
|
%
|
1,922
|
38
|
%
|
||||||||||
Selling, general and administrative expenses
|
6,001
|
93
|
%
|
4,397
|
86
|
%
|
||||||||||
Asset impairment, restructuring, severance and related costs
|
1,961
|
30
|
%
|
388
|
8
|
%
|
||||||||||
|
14,799
|
12,378
|
||||||||||||||
|
||||||||||||||||
LOSS FROM OPERATIONS
|
(8,337
|
)
|
(7,267
|
)
|
||||||||||||
|
||||||||||||||||
OTHER EXPENSE, NET
|
(727
|
)
|
(712
|
)
|
||||||||||||
|
||||||||||||||||
LOSS BEFORE INCOME TAXES
|
(9,064
|
)
|
(140
|
)%
|
(7,979
|
)
|
(156
|
)%
|
||||||||
|
||||||||||||||||
Income tax (expense) benefit
|
-
|
135
|
||||||||||||||
NET LOSS
|
$
|
(9,064
|
)
|
$
|
(7,844
|
)
|
For the three months
ended June 30,
|
Favorable/(unfavorable)
|
|||||||||||||||
|
2021
|
2020
|
$ Change
|
% Change
|
||||||||||||
Net product sales
|
$
|
3,931
|
$
|
3,792
|
$
|
139
|
3.7
|
%
|
||||||||
Less: Cost of product sales
|
(4,040
|
)
|
(5,671
|
)
|
1,631
|
28.8
|
%
|
|||||||||
Gross product margin
|
$
|
(109
|
)
|
$
|
(1,879
|
)
|
$
|
1,770
|
94.2
|
%
|
||||||
Gross product margin percentage
|
(2.8
|
)%
|
(49.6
|
)%
|
For the three months
ended June 30,
|
Favorable/(unfavorable)
|
|||||||||||||||
|
2021
|
2020
|
$ Change
|
% Change
|
||||||||||||
Clinical and regulatory affairs
|
$
|
871
|
$
|
178
|
$
|
(693
|
)
|
$
|
(389.3
|
)%
|
||||||
Other research and development
|
1,926
|
1,744
|
(182
|
)
|
(10.4
|
)%
|
||||||||||
Total research and development
|
$
|
2,797
|
$
|
1,922
|
$
|
(875
|
)
|
(45.5
|
)%
|
•
|
We recorded an impairment loss of $1.3 million for the three months ended June 30, 2021 as the result of our write-off of the intangible assets, net, leasehold improvements, net and right-of-use assets for leases, net associated with our Malaysian operations, which underwent a retrenchment during the second quarter of 2020. See “—Recent Events—Non-Cash Write-Downs.”
|
•
|
In light of the uncertainty of the timing and receipt of 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 we engaged the services of an independent financial advisory firm. The financial advisory firm worked with management to develop a forecast model to assess the amount and timing of our liquidity needs, assuming various business cases, and together with legal counsel advised us regarding alternative approaches to enhancing our liquidity position, participating in discussions with the Lender, and related matters. During the three months ended June 30, 2021, we incurred $0.7 million related to these restructuring matters.
|
For the six months ending June 30,
|
||||||||||||||||
|
2021
|
2020
|
||||||||||||||
|
||||||||||||||||
TOTAL REVENUES
|
$
|
15,186
|
100
|
%
|
$
|
11,971
|
100
|
%
|
||||||||
|
||||||||||||||||
OPERATING COSTS AND EXPENSES:
|
||||||||||||||||
Cost of product sales
|
7,588
|
50
|
%
|
10,045
|
84
|
%
|
||||||||||
Research and development expenses
|
5,660
|
37
|
%
|
3,881
|
32
|
%
|
||||||||||
Selling, general and administrative expenses
|
12,087
|
80
|
%
|
8,554
|
71
|
%
|
||||||||||
Asset impairment, restructuring, severance and related costs
|
2,044
|
13
|
%
|
1,111
|
9
|
%
|
||||||||||
Acquisition
|
-
|
-
|
64
|
1
|
%
|
|||||||||||
|
27,379
|
23,655
|
||||||||||||||
|
||||||||||||||||
LOSS FROM OPERATIONS
|
(12,193
|
)
|
(11,684
|
)
|
||||||||||||
|
||||||||||||||||
OTHER EXPENSE, NET
|
(1,440
|
)
|
(1,374
|
)
|
||||||||||||
|
||||||||||||||||
LOSS BEFORE INCOME TAXES
|
(13,633
|
)
|
(90
|
)%
|
(13,058
|
)
|
(109
|
)%
|
||||||||
|
||||||||||||||||
Income tax (expense) benefit
|
68
|
215
|
||||||||||||||
NET LOSS
|
$
|
(13,565
|
)
|
$
|
(12,843
|
)
|
For the six months
ended June 30,
|
Favorable/(unfavorable)
|
|||||||||||||||
|
2021
|
2020
|
$ Change
|
% Change
|
||||||||||||
Net product sales
|
$
|
7,956
|
$
|
9,508
|
$
|
(1,552
|
)
|
(16.3
|
)%
|
|||||||
Less: Cost of product sales
|
(7,588
|
)
|
(10,045
|
)
|
2,457
|
24.5
|
%
|
|||||||||
Gross product margin
|
$
|
368
|
$
|
(537
|
)
|
$
|
905
|
168.5
|
%
|
|||||||
Gross product margin percentage
|
4.6
|
%
|
(5.6
|
)%
|
For the six months
ended June 30,
|
Favorable/(unfavorable)
|
|||||||||||||||
|
2021
|
2020
|
$ Change
|
% Change
|
||||||||||||
Clinical and regulatory affairs
|
$
|
1,636
|
$
|
500
|
$
|
(1,136
|
)
|
$
|
(227.2
|
)%
|
||||||
Other research and development
|
4,024
|
3,381
|
(643
|
)
|
(19.0
|
)%
|
||||||||||
Total research and development
|
$
|
5,660
|
$
|
3,881
|
$
|
(1,779
|
)
|
(45.8
|
)%
|
•
|
We recorded an impairment loss of $1.3 million for the six months ended June 30, 2021 as the result of our write-off of the intangible assets, net, leasehold improvements, net and right-of-use assets for leases, net associated with our Malaysian operations, which underwent a retrenchment during the second quarter of 2020. See “—Recent Events—Non-Cash Writedowns.”
|
•
|
In light of the uncertainty of the timing and receipt of 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 we engaged the services of an independent financial advisory firm. The financial advisory firm worked with management to develop a forecast model to assess the amount and timing of our liquidity needs, assuming various business cases, and together with legal counsel advised us regarding alternative approaches to enhancing our liquidity position, participating in discussions with the Lender, and related matters. During the six months ended June 30, 2021, we 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 we 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 during the six months ended June 30, 2021.
|
● |
Principal Amount. 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, we may use the proceeds (a) for general working capital purposes and other permitted corporate purposes, (b) to refinance certain of our existing indebtedness and (c) 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, our financial advisor for the financing.
|
● |
Interest Rate. 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 (as described under “—Default Provisions” below) 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%.
|
● |
Scheduled Repayment. No principal repayments are due prior to September 30, 2022, unless we elect to prepay principal as described under “—Optional Prepayment” below or principal is accelerated pursuant to an event of default as described under “—Default Provisions” below. 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.
|
● |
Optional Prepayment. We may prepay outstanding principal from time to time, subject to payment of a premium on the prepaid principal amount equal to 8% 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.
|
● |
Guaranties. Our subsidiaries Chembio Diagnostic Systems Inc. and Chembio Diagnostics Malaysia Sdn Bhd. have guaranteed, and the Lender from time to time may require our other subsidiaries to guarantee, our obligations under the Credit Agreement.
|
● |
Security. Our obligations under the Credit Agreement are secured by a first priority, perfected lien on substantially all of our property and assets, including our equity interests in our subsidiaries. Our subsidiary Chembio Diagnostic Systems Inc. has secured its guarantee of our Credit Agreement obligations with a lien on substantially all of its assets, and the Lender from time to time may require Chembio Diagnostics Malaysia Sdn Bhd. and any of our other subsidiaries that has guaranteed our Credit Agreement obligations to do the same.
|
● |
Representations and Warranties; Financial and Other Covenants. In the Credit Agreement we made customary representations and warranties as well as customary affirmative and negative covenants, including covenants limiting additional indebtedness, liens, guaranties, mergers and acquisitions, substantial asset sales, investments and loans, sale and leasebacks, transactions with affiliates, and fundamental changes. The Credit Agreement also contains financial covenants requiring that (a) we maintain aggregate unrestricted cash of not less than $3,000,000 at all times and (b) we achieve specified minimum total revenue requirements for the 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 our management and board of directors to understand and evaluate our operating performance, to establish budgets, and to establish operational goals for managing our business. We therefore do not believe that the covenant requirements provide useful information to investors or others in enhancing an understanding of our future prospects. the Credit Agreement for the next twelve months, which include attaining Minimum Total Revenue (as such term is defined in the Credit Agreement) requirements for the twelve months preceding each quarter end. For the next year, the minimum total revenue requirements range from $37.4 million for the twelve months ending September 30, 2021 to $43.8 million for the twelve months ending June 30, 2022 (see Note 7 – Long-Term Debt).
|
● |
Default Provisions. The Credit Agreement provides for customary events of default, including events of default based on non-payment of amounts due under the Credit Agreement, defaults on other debt, misrepresentations, covenant breaches, changes of control, insolvency, bankruptcy and the occurrence of a material adverse effect on our company. Upon an event of default resulting from a voluntary or involuntary proceeding for bankruptcy, insolvency or receivership, the amounts outstanding under the Credit Agreement will become immediately due and payable and the Lender’s commitments will be automatically terminated. Upon the occurrence and continuation of any other event of default, the Lender may accelerate payment of all obligations and terminate its commitments under the Credit Agreement. Upon an acceleration of payment following an event of default occurring prior to September 4, 2021, the amounts due and payable by us will include a prepayment premium on accelerated principal in the amount described under “—Optional Prepayment” above.
|
June 30, 2021
|
||||
Cash and cash equivalents
|
$
|
5,564
|
||
Accounts receivable, net of allowance for doubtful amounts
|
2,977
|
|||
Inventories, net
|
15,720
|
|||
Prepaid expenses and other current assets
|
1,065
|
|||
Total current assets
|
25,326
|
|||
Less: Total current liabilities
|
9,428
|
|||
Working capital
|
$
|
15,898
|
ITEM 4. |
CONTROLS AND PROCEDURES
|
PART II. |
OTHER INFORMATION
|
ITEM 1. |
LEGAL PROCEEDINGS
|
This information is set forth under “Note 6(f) – Commitments, Contingencies and Concentrations – Litigation – Legal Proceedings” to the Accompanying Financial Statements and is incorporated herein by reference.
|
ITEM 1A. |
RISK FACTORS
|
• |
third parties lose confidence in our ability to continue to operate in the ordinary course, which could impact our ability to execute on our business strategy;
|
• |
it may become more difficult for us to attract, retain or replace employees;
|
• |
employees could be distracted from performance of their duties;
|
• |
we could lose some or a significant portion of our liquidity, either due to stricter credit terms from vendors, or, in the event we undertake a Chapter 11 proceeding and conclude that we need to procure debtor-in-possession financing, an inability to obtain any needed debtor-in-possession financing or to provide adequate protection to certain secured lenders to permit us to access some or all of our cash; and
|
• |
our vendors and service providers could seek to renegotiate the terms of our arrangements, terminate their relationships with us or require financial assurances from us.
|
• |
incur, assume or guarantee additional Indebtedness (as defined in the Credit Agreement);
|
• |
repurchase capital stock;
|
• |
make other restricted payments, including paying dividends and making investments;
|
• |
create liens;
|
• |
sell or otherwise dispose of assets, including capital stock of subsidiaries;
|
• |
enter into agreements that restrict dividends from subsidiaries;
|
• |
enter into mergers or consolidations; and
|
• |
enter into transactions with affiliates.
|
ITEM 6. |
EXHIBITS
|
Number
|
|
Description
|
Amendment No. 1 to Amended and Restated Bylaws of Chembio Diagnostics, Inc.
|
||
|
At the Market Offering Agreement, dated July 19, 2021, between Chembio Diagnostics, Inc. and Craig-Hallum Capital Group LLC (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed on July 19, 2021)
|
|
|
Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
101.INS
|
|
XBRL Instance Document
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF
|
|
XBRL Taxonomy Definition Linkbase Document
|
101.LAB
|
|
XBRL Taxonomy Label Linkbase Document
|
101.PRE
|
|
XBRL Taxonomy Presentation Linkbase Document
|
104
|
Cover page interactive date file (embedded within the XBRL document)
|
|
Chembio Diagnostics, Inc.
|
|
|
Date: August 9, 2021
|
By: /s/ Richard Eberly
|
|
Richard Eberly
|
|
Chief Executive Officer and President
|
|
|
Date: August 9, 2021
|
By: /s / Neil A. Goldman
|
|
Neil A. Goldman
|
|
Chief Financial Officer and Executive Vice President
|
Date: August 9, 2021 |
/s/ Richard L. Eberly
|
|
Richard L. Eberly |
|
Chief Executive Officer and President |
(Principal Executive Officer) |
Date: August 9, 2021
|
/s/ Neil A. Goldman
|
Neil A. Goldman
|
|
Chief Financial Officer and Executive Vice President
|
|
(Principal Financial Officer)
|
Date: August 9, 2021
|
/s/ Richard L. Eberly
|
Richard L. Eberly
|
|
Chief Executive Officer and President
|
|
(Principal Executive Officer)
|
Date: August 9, 2021
|
/s/ Neil A. Goldman
|
Neil A. Goldman
|
|
Chief Financial Officer and Executive Vice President
|
|
(Principal Financial Officer)
|