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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Chembio Diagnostics Inc | NASDAQ:CEMI | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.455 | 0.44 | 0.46 | 0 | 01:00:00 |
☒ |
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
|
|
|
|
3
|
||
|
|
|
Part I. FINANCIAL INFORMATION:
|
|
|
|
|
|
|
Item 1. Financial Statements:
|
|
|
|
|
|
4
|
|
|
|
|
|
5
|
|
|
|
|
|
6
|
|
|
|
|
|
7
|
|
|
|
|
|
9
|
|
|
|
|
|
10
|
|
|
|
|
|
27
|
|
|
|
|
|
43
|
|
|
|
|
Part II. OTHER INFORMATION:
|
|
|
|
|
|
|
44
|
|
|
|
|
|
45
|
|
|
|
|
|
52
|
|
|
|
|
53
|
Item 1. |
FINANCIAL STATEMENTS
|
|
For the Three Months Ended
|
For the Six Months Ended
|
||||||||||||||
June 30, 2020
|
June 30, 2019
|
June 30, 2020
|
June 30, 2019
|
|||||||||||||
REVENUES:
|
||||||||||||||||
Net product sales
|
$
|
3,791,574
|
$
|
8,785,041
|
$
|
9,508,166
|
$
|
15,409,326
|
||||||||
R&D and grant revenue
|
1,193,973
|
854,264
|
2,101,660
|
2,556,053
|
||||||||||||
License and royalty revenue
|
125,625
|
248,831
|
360,929
|
465,022
|
||||||||||||
TOTAL REVENUES
|
5,111,172
|
9,888,136
|
11,970,755
|
18,430,401
|
||||||||||||
COSTS AND EXPENSES:
|
||||||||||||||||
Cost of product sales
|
5,670,737
|
6,989,975
|
10,045,179
|
12,001,611
|
||||||||||||
Research and development expenses
|
1,922,306
|
2,101,020
|
3,881,159
|
4,318,652
|
||||||||||||
Selling, general and administrative expenses
|
4,397,593
|
4,096,942
|
8,554,234
|
8,110,013
|
||||||||||||
Severance, restructuring and other related costs
|
387,540
|
-
|
1,110,658
|
-
|
||||||||||||
Acquisition costs
|
-
|
-
|
63,497
|
395,612
|
||||||||||||
12,378,176
|
13,187,937
|
23,654,727
|
24,825,888
|
|||||||||||||
LOSS FROM OPERATIONS
|
(7,267,004
|
)
|
(3,299,801
|
)
|
(11,683,972
|
)
|
(6,395,487
|
)
|
||||||||
OTHER INCOME:
|
||||||||||||||||
Interest (expense) income
|
(712,052
|
)
|
5,918
|
(1,374,192
|
)
|
12,602
|
||||||||||
LOSS BEFORE INCOME TAXES
|
(7,979,056
|
)
|
(3,293,883
|
)
|
(13,058,164
|
)
|
(6,382,885
|
)
|
||||||||
Income tax benefit
|
(135,259
|
)
|
(107,203
|
)
|
(214,818
|
)
|
(379,672
|
)
|
||||||||
NET LOSS
|
$
|
(7,843,797
|
)
|
$
|
(3,186,680
|
)
|
$
|
(12,843,346
|
)
|
$
|
(6,003,213
|
)
|
||||
Basic loss per share
|
$
|
(0.42
|
)
|
$
|
(0.19
|
)
|
$
|
(0.71
|
)
|
$
|
(0.36
|
)
|
||||
Diluted loss per share
|
$
|
(0.42
|
)
|
$
|
(0.19
|
)
|
$
|
(0.71
|
)
|
$
|
(0.36
|
)
|
||||
Weighted average number of shares outstanding, basic
|
18,868,144
|
16,914,171
|
18,032,723
|
16,906,936
|
||||||||||||
Weighted average number of shares outstanding, diluted
|
18,868,144
|
16,914,171
|
18,032,723
|
16,906,936
|
|
For the Three Months Ended
|
For the Six Months Ended
|
||||||||||||||
|
June 30, 2020
|
June 30, 2019
|
June 30, 2020
|
June 30, 2019
|
||||||||||||
Net loss
|
$
|
(7,843,797
|
)
|
$
|
(3,186,680
|
)
|
$
|
(12,843,346
|
)
|
$
|
(6,003,213
|
)
|
||||
Other comprehensive loss:
|
||||||||||||||||
Foreign currency translation adjustments
|
(175,447
|
)
|
(313,225
|
)
|
(1,038,741
|
)
|
(111,039
|
)
|
||||||||
Comprehensive loss
|
$
|
(8,019,244
|
)
|
$
|
(3,499,905
|
)
|
$
|
(13,882,087
|
)
|
$
|
(6,114,252
|
)
|
|
For The Six Months Ended June 30, 2020
|
|||||||||||||||||||||||||||||||
Common Stock
|
Additional
Paid-in-Capital |
Treasury
Stock
|
Accumulated
Deficit
|
Accumulated Other
Comprehensive
Income
|
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
|
|
For The Six Months Ended June 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
|
(a) |
Basis of Presentation:
|
(b) |
Use of Estimates:
|
(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) |
Concentrations of Credit Risk:
|
(f) |
Fixed Assets:
|
(g) |
License Agreements:
|
(h) |
Valuation of Long-Lived Assets and Intangible Assets:
|
(i) |
Revenue Recognition:
|
|
For the Three Months Ended
|
|||||||||||||||||||||||
June 30, 2020
|
June 30, 2019
|
|||||||||||||||||||||||
Exchange
Transactions
|
Non-Exchange
Transactions
|
Total
|
Exchange
Transactions
|
Non-Exchange
Transactions
|
Total
|
|||||||||||||||||||
Net product sales
|
$
|
3,791,574
|
$
|
-
|
$
|
3,791,574
|
$
|
8,785,041
|
$
|
-
|
$
|
8,785,041
|
||||||||||||
R&D and grant revenue
|
1,193,973
|
-
|
1,193,973
|
619,139
|
235,125
|
854,264
|
||||||||||||||||||
License and royalty revenue
|
125,625
|
-
|
125,625
|
248,831
|
-
|
248,831
|
||||||||||||||||||
$
|
5,111,172
|
$
|
-
|
$
|
5,111,172
|
$
|
9,653,011
|
$
|
235,125
|
$
|
9,888,136
|
|
For the Six Months Ended
|
|||||||||||||||||||||||
June 30, 2020
|
June 30, 2019
|
|||||||||||||||||||||||
Exchange
Transactions
|
Non-Exchange
Transactions
|
Total
|
Exchange
Transactions
|
Non-Exchange
Transactions
|
Total
|
|||||||||||||||||||
Net product sales
|
$
|
9,508,167
|
$
|
-
|
$
|
9,508,166
|
$
|
15,409,326
|
$
|
-
|
$
|
15,409,326
|
||||||||||||
R&D and grant revenue
|
2,101,660
|
-
|
2,101,660
|
1,392,204
|
1,163,849
|
2,556,053
|
||||||||||||||||||
License and royalty revenue
|
360,928
|
-
|
360,929
|
465,022
|
-
|
465,022
|
||||||||||||||||||
$
|
11,970,755
|
$
|
-
|
$
|
11,970,755
|
$
|
17,266,552
|
$
|
1,163,849
|
$
|
18,430,401
|
|
For the Three Months Ended
|
For the Six Months Ended
|
||||||||||||||
|
June 30, 2020
|
June 30, 2019
|
June 30, 2020
|
June 30, 2019
|
||||||||||||
Africa
|
$
|
552,570
|
$
|
2,342,740
|
$
|
1,436,085
|
$
|
4,759,040
|
||||||||
Asia
|
119,319
|
119,548
|
482,607
|
240,646
|
||||||||||||
Europe & Middle East
|
1,635,016
|
1,107,558
|
3,811,172
|
3,250,779
|
||||||||||||
Latin America
|
780,567
|
4,897,297
|
2,896,963
|
6,177,770
|
||||||||||||
United States
|
2,023,699
|
1,420,993
|
3,343,928
|
4,002,166
|
||||||||||||
$
|
5,111,172
|
$
|
9,888,136
|
$
|
11,970,755
|
$
|
18,430,401
|
(j) |
Inventories:
|
|
June 30, 2020
|
December 31, 2019
|
||||||
Raw materials
|
$
|
5,136,583
|
$
|
2,901,319
|
||||
Work in process
|
2,609,407
|
793,343
|
||||||
Finished goods
|
6,385,550
|
5,903,368
|
||||||
|
$
|
14,131,540
|
$
|
9,598,030
|
(k) |
Loss Per Share:
|
(l) |
Research and Development:
|
(m) |
Equity Plans:
|
(n) |
Stock-Based Compensation:
|
|
For The Three Months Ended
June 30,
|
For The Six Months Ended
June 30,
|
||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
Cost of product sales
|
$
|
-
|
$
|
2,300
|
$
|
6,300
|
$
|
5,800
|
||||||||
Research and development expenses
|
90,924
|
56,300
|
154,737
|
116,100
|
||||||||||||
Selling, general and administrative expenses
|
293,301
|
318,300
|
610,089
|
602,478
|
||||||||||||
Severance and related costs
|
-
|
-
|
(423,984
|
)
|
-
|
|||||||||||
$
|
384,225
|
$
|
376,900
|
$
|
347,142
|
$
|
724,378
|
|
For the Three and
Six Months Ended June 30, 2020
|
|||
Expected term (in years)
|
6.3
|
|||
Expected volatility
|
45.37
|
%
|
||
Expected dividend yield
|
0.00
|
%
|
||
Risk-free interest rate
|
1.33
|
%
|
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
|
(275,000)
|
3.59
|
||||||||
Outstanding at June 30, 2020
|
1,034,124
|
$
|
4.12
|
6 years
|
$
|
598,628
|
||||
Exercisable at June 30, 2020
|
224,333
|
$
|
7.24
|
3 years
|
$
|
-
|
|
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
|
672,616
|
6.71
|
$
|
2.36
|
$
|
598,628
|
-
|
$
|
-
|
$
|
-
|
|||||||
$2.8 to $4.59999
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||
$4.6 to $6.39999
|
106,758
|
2.94
|
5.78
|
-
|
58,125
|
5.77
|
-
|
|||||||||||
$6.4 to $8.19999
|
207,875
|
3.56
|
7.31
|
-
|
147,458
|
7.28
|
-
|
|||||||||||
$8.2 to $12
|
46,875
|
3.10
|
11.45
|
-
|
18,750
|
11.45
|
-
|
|||||||||||
Total
|
1,034,124
|
5.52
|
$
|
4.12
|
$
|
598,628
|
224,333
|
$
|
7.24
|
$
|
-
|
|
Number of
Shares & Units
|
Weighted-
Average
Grant Date
Fair Value
|
||||||
Outstanding at December 31, 2019
|
545,986
|
$
|
7.47
|
|||||
Granted
|
610,301
|
2.57
|
||||||
Vested
|
(66,728
|
)
|
3.62
|
|||||
Forfeited/expired/cancelled
|
(470,174
|
)
|
6.58
|
|||||
Outstanding at June 30, 2020
|
619,385
|
$
|
3.32
|
(o) |
Geographic Information and Economic Dependency
|
|
For The Three Months Ended
June 30,
|
For The Six Months Ended
June 30,
|
||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
Africa
|
$
|
552,570
|
$
|
2,342,740
|
$
|
1,436,085
|
$
|
4,759,040
|
||||||||
Asia
|
119,319
|
119,548
|
482,607
|
240,646
|
||||||||||||
Europe & Middle East
|
734,073
|
741,641
|
1,909,162
|
1,919,666
|
||||||||||||
Latin America
|
780,567
|
4,897,297
|
2,896,963
|
6,177,770
|
||||||||||||
United States
|
1,605,045
|
683,815
|
2,783,349
|
2,312,204
|
||||||||||||
$
|
3,791,574
|
$
|
8,785,041
|
$
|
9,508,166
|
$
|
15,409,326
|
|
June 30, 2020
|
December 31, 2019
|
||||||
Asia
|
$
|
357,921
|
$
|
393,299
|
||||
Europe & Middle East
|
171,767
|
165,029
|
||||||
Latin America
|
43,701
|
60,527
|
||||||
United States
|
7,132,501
|
5,314,714
|
||||||
|
$
|
7,705,890
|
$
|
5,933,569
|
(p) |
Accounts Payable and Accrued Liabilities:
|
|
June 30, 2020
|
December 31, 2019
|
||||||
Accounts payable – suppliers
|
$
|
6,588,598
|
$
|
3,144,098
|
||||
Accrued commissions and royalties
|
486,998
|
931,760
|
||||||
Accrued payroll
|
188,858
|
231,753
|
||||||
Accrued vacation
|
547,307
|
410,199
|
||||||
Accrued bonuses
|
350,479
|
215,000
|
||||||
Accrued severance
|
260,481
|
-
|
||||||
Accrued expenses – other
|
868,166
|
593,433
|
||||||
TOTAL
|
$
|
9,290,887
|
$
|
5,526,243
|
(q) |
Goodwill, Long-Lived Assets and Intangible Assets:
|
Beginning balance at December 31, 2019
|
$
|
5,872,690
|
||
Change in foreign currency exchange rate
|
(338,066
|
)
|
||
Balance at June 30, 2020
|
$
|
5,534,624
|
|
June 30, 2020
|
December 31, 2019
|
||||||||||||||||||
Weighted
Average
Remaining
Useful Life
|
Cost
|
Accumulated
Amortization
|
Net Book
Value
|
Cost
|
Accumulated
Amortization
|
Net Book
Value
|
||||||||||||||
Intellectual property
|
6
|
$
|
1,470,556
|
$
|
366,353
|
$
|
1,104,203
|
$
|
1,418,681
|
$
|
299,232
|
$
|
1,119,449
|
|||||||
Developed technology
|
6
|
1,924,990
|
400,304
|
1,524,686
|
1,922,682
|
266,550
|
1,656,132
|
|||||||||||||
Customer contracts/relationships
|
7
|
1,232,474
|
327,525
|
904,949
|
1,325,521
|
270,902
|
1,054,619
|
|||||||||||||
Trade names
|
8
|
107,796
|
36,440
|
71,356
|
114,946
|
30,794
|
84,152
|
|||||||||||||
$
|
4,735,816
|
$
|
1,130,622
|
$
|
3,605,194
|
$
|
4,781,830
|
$
|
867,478
|
$
|
3,914,352
|
(r) |
Taxes:
|
(s) |
Allowance for Doubtful Accounts:
|
(t) |
Foreign Currency Translation:
|
(u) |
Acquisition Costs:
|
(v) |
Recently Issued Accounting Standards:
|
(w) |
Severance, restructuring and other related costs:
|
● |
$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 product 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.
|
|
Amount
|
|||
Net current assets
|
$
|
320,293
|
||
Property, plant and equipment and other assets
|
226,035
|
|||
Inventory
|
289,205
|
|||
Goodwill
|
986,058
|
|||
Deferred tax liability
|
(50,000
|
)
|
||
Other intangible assets (estimated useful life):
|
||||
Trade name (0.5 years)
|
5,000
|
|||
Customer contracts / relationships (5 years)
|
195,000
|
|||
Total consideration
|
$
|
1,971,591
|
|
Unaudited
Pro Forma
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
|
)
|
(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, 2020
|
June 30, 2019
|
June 30, 2020
|
June 30, 2019
|
June 30, 2020
|
Dec. 31, 2019
|
|||||||||||||||||||||||||||||||||||
Sales
|
% of Sales
|
Sales
|
% of Sales
|
Sales
|
% of Sales
|
Sales
|
% of Sales
|
|||||||||||||||||||||||||||||||||
Customer 1
|
$
|
657,304
|
17.0
|
%
|
$
|
4,573,434
|
54
|
%
|
$
|
2,297,376
|
24.0
|
%
|
$
|
5,615,932
|
38
|
%
|
$
|
806,196
|
$
|
941,962
|
||||||||||||||||||||
Customer 2
|
$
|
-
|
0.0
|
%
|
$
|
1,627,075
|
19
|
%
|
$
|
-
|
0.0
|
%
|
$
|
3,460,666
|
23
|
%
|
$
|
-
|
$
|
-
|
(b) |
Governmental Regulation:
|
(c) |
Employment Contracts:
|
2020
|
$
|
382,500
|
||
2021
|
765,000
|
|||
2022
|
400,000
|
(d) |
Pension Plan:
|
(e) |
Leases:
|
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
Operating lease expense
|
$
|
388,951
|
$
|
400,658
|
$
|
852,808
|
$
|
682,261
|
||||||||
Finance lease cost
|
||||||||||||||||
Amortization of right-of-use assets
|
$
|
14,687
|
$
|
-
|
$
|
27,085
|
$
|
-
|
||||||||
Interest on lease liabilities
|
5,156
|
-
|
9,367
|
-
|
||||||||||||
Total finance lease expense
|
$
|
19,843
|
$
|
-
|
$
|
36,452
|
$
|
-
|
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
Cash paid for amounts included in the measurement of lease liabilities:
|
||||||||||||||||
Operating cash flows for operating leases
|
$
|
292,058
|
$
|
147,107
|
$
|
457,277
|
$
|
305,157
|
||||||||
Operating cash flows for finance leases
|
5,156
|
-
|
9,367
|
-
|
||||||||||||
Financing cash flows for finance leases
|
12,666
|
-
|
23,578
|
-
|
||||||||||||
Right-of-use assets obtained in exchange for lease obligations:
|
||||||||||||||||
Operating leases
|
-
|
-
|
-
|
6,949,611
|
||||||||||||
Finance leases
|
$
|
47,499
|
$
|
233,722
|
$
|
75,852
|
$
|
233,722
|
|
June 30, 2020
|
June 30, 2019
|
||||||
Finance Leases
|
||||||||
Finance lease right of use asset
|
$
|
309,574
|
$
|
233,722
|
||||
Accumulated depreciation
|
(50,690
|
)
|
-
|
|||||
Finance lease right of use asset, net
|
$
|
258,884
|
233,722
|
|||||
|
||||||||
Weighted-Average Remaining Lease Term
|
||||||||
Operating leases
|
9 years
|
10 years
|
||||||
Finance leases
|
4 years
|
5 years
|
||||||
|
||||||||
Weighted-Average Discount Rate
|
||||||||
Operating leases
|
8.62
|
%
|
8.52
|
%
|
||||
Finance leases
|
9.73
|
%
|
7.0
|
%
|
|
June 30, 2020
|
June 30, 2019
|
||||||||||||||
|
Operating
Leases
|
Finance
Leases
|
Operating
Leases
|
Finance
Leases
|
||||||||||||
2019 and 2020
|
$
|
682,667
|
$
|
37,720
|
$
|
1,129,543
|
$
|
27,768
|
||||||||
2021
|
1,209,787
|
75,440
|
998,071
|
55,536
|
||||||||||||
2022
|
1,057,757
|
75,440
|
1,026,044
|
55,536
|
||||||||||||
2023
|
1,026,272
|
75,440
|
1,011,085
|
55,536
|
||||||||||||
2024
|
1,018,875
|
47,672
|
-
|
55,536
|
||||||||||||
Thereafter
|
5,773,887
|
4,774
|
6,792,767
|
27,767
|
||||||||||||
Total lease payments
|
$
|
10,769,245
|
$
|
316,486
|
$
|
10,957,510
|
$
|
277,679
|
||||||||
Less: imputed interest
|
3,427,535
|
50,366
|
3,986,013
|
43,957
|
||||||||||||
Total
|
$
|
7,341,710
|
$
|
266,120
|
$
|
6,971,497
|
$
|
233,722
|
(f) |
Litigation:
|
Stock price on issuance date
|
$
|
5.40
|
||
Strike Price
|
$
|
5.22
|
||
Risk-free interest rate
|
1.45
|
%
|
||
Volatility
|
43.65
|
%
|
||
Expected life
|
7 years
|
• |
We acquired three regulatory approvals of the DPP COVID-19 System in our targeted global testing market: an Emergency Use Authorization, or EUA, granted by the U.S. Food and Drug Administration, or FDA, in April 2020; an approval for emergency use issued by Brazil’s Agência Nacional de Vigilância Sanitária, or ANVISA, in April 2020, and a CE Marking for the European Union obtained in early May 2020.
|
• |
Stony Brook Medicine selected the DPP COVID-19 System to help identify persons who have recovered from COVID-19 for use in an FDA-approved investigation to determine if those persons’ convalescent blood plasma can help treat patients with an active COVID-19 infection.
|
• |
We began shipping the DPP COVID-19 System to fulfill a $4 million purchase order from Bio-Manguinhos, a long-standing customer that is a subsidiary of the foundation responsible for the development and production of vaccines, diagnostics and biopharmaceuticals for Brazil’s national public health system.
|
• |
We initiated commercial shipments of the DPP COVID-19 System to customers in the United States.
|
• |
We strengthened our balance sheet by raising $28.4 million in a secondary public offering in May 2020.
|
• |
We stablished a non-exclusive distribution relationship with Thermo Fisher Scientific’s healthcare channel for the distribution of Chembio’s DPP COVID-19 System in the U.S.
|
• |
We stand behind the real-world clinical data, including that which we submitted to the FDA, in connection with the DPP COVID-19 IgM/IgG System EUA, and
|
• |
The FDA’s recent identification of the performance criteria for COVID-19 serology tests clarified our path forward in working to revise the DPP COVID-19 IgM/IgG System to meet or exceed current FDA requirements.
|
• |
We acknowledge the policy change that led the FDA to create performance criteria and rely on the NCI study for those purposes.
|
• |
On April 15, 2020, the DPP COVID-19 IgM/IgG System was granted an EUA. Subsequently, the FDA announced the adoption of a performance review process based in part on a NCI methodology for the evaluation of COVID 19 serology tests. The NCI report acknowledges that this process, which evaluates COVID-19 serology test sensitivity and specificity using a panel of pre-selected samples, may not be indicative of either performance in the real-world or performance of finger stick blood as used in the Chembio system.
|
• |
In addition, the NCI study does not invalidate the real-world clinical data that we submitted to the FDA, including that compiled by Chembio as well as independent evaluators at two university medical centers.
|
• |
The importance of our system’s real-world performance has been highlighted by a number of customers.
|
• |
enhanced sensitivity and specificity;
|
• |
advanced multiplexing; and
|
• |
when used with our Micro Reader, accurate results processed in approximately 15 seconds.
|
Product
|
U.S.
|
International
|
DPP COVID-19 IgM/IgG System
|
✓
|
|
DPP HIV 1/2 Assay
|
✓
|
✓
|
DPP HIV-Syphilis System
|
Pending FDA Approval
|
✓
|
DPP Syphilis Screen & Confirm Assay
|
✓
|
|
DPP ZCD IgM/IgG System
|
✓
|
|
DPP Dengue NS1 Antigen System
|
✓
|
|
DPP Dengue IgM/IgG System
|
✓
|
|
DPP Zika IgM System
|
✓
|
✓
|
DPP Zika IgM/IgG System
|
✓
|
|
DPP Chikungunya System
|
✓
|
|
DPP Ebola Antigen System
|
✓ EUA
|
|
DPP Leishmaniasis Assay
|
✓
|
|
HIV 1/2 STAT-PAK Assay
|
✓
|
✓
|
Chagas STAT-PAK Assay
|
✓
|
|
SURE CHECK HIV 1/2 Assay
|
✓
|
✓
|
SURE CHECK HIV Self-Test
|
✓
|
• |
our registration of existing and new products in unchartered countries and regions, such as selected countries in Latin America and Southeast Asia;
|
• |
our entry into new market segments, such as international HIV self-testing; and
|
• |
advances in our product pipeline in infectious disease with key products, including a multiplex test for HIV and Syphilis targeted for sale in the United States and tests for Chikungunya, Dengue and Zika for sale internationally.
|
• |
HIV has claimed more than 35 million lives, including 770,000 in 2018. Approximately 37.9 million people were living with HIV at the end of 2018, and 1.7 million were newly infected during 2018.
|
• |
There were 18.0 million prevalent cases of Syphilis as of 2012, and 5.6 million new infections were estimated to occur annually.
|
• |
Elimination of mother-to-child transmission, or MTCT, of both HIV and Syphilis is a global health priority. In 2013, 1.9 million pregnant women were infected with Syphilis worldwide. Congenital syphilis contributes significantly to infant mortality, accounting for 305,000 annual perinatal deaths worldwide in 2013. Globally, more than 1.4 million pregnant women were infected with HIV as of 2015, and MTCT of HIV is estimated to have resulted in over 150,000 infant cases in 2015.
|
Product
|
Collaborator
|
Phase I
Feasibility
|
Phase II
Development
|
Phase III
Verification &
Validation
|
Phase IV
Clinical &
Regulatory
|
Phase V
Commercial
Launch
|
DPP HIV-Syphilis System (US)
|
Self-funded
|
✓
|
✓
|
✓
|
✓
|
PMA pending
|
DPP Dengue IgM/IgG System
|
Self-funded
|
✓
|
✓
|
✓
|
✓
|
CE and ANVISA
|
DPP Dengue NS1 Antigen System
|
Self-funded
|
✓
|
✓
|
✓
|
✓
|
CE and ANVISA pending
|
DPP Chikungunya IgM/IgG System
|
Self-funded
|
✓
|
✓
|
✓
|
✓
|
CE and ANVISA
|
DPP Zika Chikungunya Dengue IgM/IgG System
|
Self-funded
|
✓
|
✓
|
✓
|
✓
|
CE and ANVISA
|
DPP Ebola Antigen System
|
CDC
|
✓
|
✓
|
✓
|
✓
|
FDA-EUA
|
DPP Fever Assay Asia
|
FIND
|
✓
|
✓
|
✓
|
✓
|
|
DPP Fever Assay Africa
|
Paul Allen Foundation
|
✓
|
✓
|
✓
|
||
DPP Fever Assay Malaysia
|
Self-funded
|
✓
|
✓
|
✓
|
✓
|
• |
In January 2015 we entered into an agreement with the Concussion Science Group Division of Perseus Science Group LLC, or Perseus, to develop a rapid diagnostic test for traumatic brain injury utilizing both our DPP and optical analyzer technologies.
|
• |
In October 2017 we signed a biomarker development project agreement with AstraZeneca plc, or AstraZeneca, utilizing both our DPP and optical analyzer technologies.
|
• |
In April 2018, we entered into a collaboration agreement with LumiraDx to develop new rapid diagnostic tests for infectious diseases. Under terms of the agreement, we receive funding from LumiraDx, subject to satisfying certain milestones, to develop certain neibiw rapid infectious disease tests. Following the regulatory approval and commercialization of tests in accordance with the agreement, we will both sell reagents to, and receive royalty payments from, LumiraDx on sales of all products developed through this collaboration.
|
• |
In July 2019 we entered into a collaboration agreement with Shire, a subsidiary of Takeda Pharmaceutical to develop a novel rapid diagnostic test to detect an undisclosed biomarker.
|
• |
In March 2020 we completed the technical feasibility phase for a potential companion/compatible diagnostic test being developed in collaboration with Shire. The program is focused within Takeda’s Rare Diseases Therapeutic Area Unit, which aspires to transform the treatment of rare diseases in immunology, hematology, metabolic and lysosomal storage disorders. Based on the progress, in March 2020 Takeda provided the next tranche of funding for the next phase of the program.
|
• |
We entered into agreements with LumiraDx in March 2020 (as amended in April 2020) to, among other things, develop a diagnostic test for the detection of the COVID-19 virus and IgM and IgG antibodies on the LumiraDx platform.
|
• |
In July 2020, we were selected to conduct a second research and development services program for Takeda utilizing our DPP technology and Micro Reader analyzers.
|
Product
|
Collaborator
|
Phase I
Feasibility
|
Phase II
Development
|
Phase III Verification &Validation
|
Phase IV Clinical/
Regulatory
|
Phase V Commercial Launch
|
DPP Rare Disease (undisclosed biomarker)
|
Takeda
|
✓
|
✓
|
|||
DPP (undisclosed biomarker)
|
Takeda
|
✓
|
||||
DPP COVID-19 Antigen System
|
BARDA
|
✓
|
||||
COVID-19 Test
|
LumiraDx
|
✓
|
✓
|
✓
|
||
Infectious Disease Portfolio
|
LumiraDx
|
✓
|
✓
|
|||
DPP Biomarker Development Project
(undisclosed biomarker)
|
AstraZeneca
|
✓
|
✓
|
✓
|
CE Mark*
|
|
DPP TBI
|
Perseus
|
✓
|
✓
|
• |
patent protection;
|
• |
scientific expertise;
|
• |
ability to develop and market products and processes;
|
• |
ability to obtain required regulatory approvals;
|
• |
ability to manufacture cost-effective products that meet applicable regulatory requirements;
|
• |
access to adequate capital; and,
|
• |
ability to attract and retain qualified personnel.
|
|
June 30, 2020
|
June 30, 2019
|
||||||||||||||
TOTAL REVENUES
|
$
|
5,111
|
100
|
%
|
$
|
9,888
|
100
|
%
|
||||||||
OPERATING COSTS AND EXPENSES:
|
||||||||||||||||
Cost of product sales
|
5,671
|
111
|
%
|
6,990
|
71
|
%
|
||||||||||
Research and development expenses
|
1,922
|
38
|
%
|
2,101
|
22
|
%
|
||||||||||
Selling, general and administrative expenses
|
4,397
|
41
|
%
|
4,097
|
43
|
%
|
||||||||||
Severance and restructuring costs
|
388
|
0
|
%
|
-
|
0
|
%
|
||||||||||
12,378
|
13,188
|
|||||||||||||||
LOSS FROM OPERATIONS
|
(7,267
|
)
|
(3,300
|
)
|
||||||||||||
OTHER (EXPENSE) INCOME, NET
|
(712
|
)
|
6
|
|||||||||||||
LOSS BEFORE INCOME TAXES
|
(7,979
|
)
|
(156
|
)%
|
(3,294
|
)
|
(36
|
)%
|
||||||||
Income tax benefit
|
(135
|
)
|
(107
|
)
|
||||||||||||
NET LOSS
|
$
|
(7,844
|
)
|
$
|
(3,187
|
)
|
For the Three Months
Ended June 30
|
Favorable/(Unfavorable)
|
|||||||||||||||
2020
|
2019
|
$ Change
|
% Change
|
|||||||||||||
Net product sales
|
$
|
3,792
|
$
|
8,785
|
$
|
(4,993
|
)
|
56.8
|
%
|
|||||||
Less: Cost of product sales
|
(5,671
|
)
|
(6,990
|
)
|
1,319
|
18.9
|
%
|
|||||||||
Gross product margin
|
$
|
(1,879
|
)
|
$
|
1,795
|
$
|
(3,674
|
)
|
204.7
|
%
|
||||||
Gross product margin percentage
|
(49.6
|
)%
|
20.4
|
%
|
• |
$1 million unfavorable product sales volume as described above, together with
|
• |
$2.6 million unfavorable product margins related to the cost of returned product and product shipped outside the U.S.
|
For the Three Months
Ended June 30
|
Favorable/(Unfavorable)
|
|||||||||||||||
2020
|
2019
|
$ Change
|
% Change
|
|||||||||||||
Clinical and regulatory affairs
|
$
|
178
|
$
|
323
|
$
|
145
|
44.9
|
%
|
||||||||
Other research and development
|
1,744
|
1,778
|
34
|
1.9
|
%
|
|||||||||||
Total research and development
|
$
|
1,922
|
$
|
2,101
|
$
|
179
|
8.5
|
%
|
June 30, 2020
|
June 30, 2019
|
|||||||||||||||
TOTAL REVENUES
|
$
|
11,971
|
100
|
%
|
$
|
18,430
|
100
|
%
|
||||||||
OPERATING COSTS AND EXPENSES:
|
||||||||||||||||
Cost of product sales
|
10,045
|
84
|
%
|
12,002
|
65
|
%
|
||||||||||
Research and development expenses
|
3,881
|
32
|
%
|
4,318
|
23
|
%
|
||||||||||
Selling, general and administrative expenses
|
8,554
|
71
|
%
|
8,110
|
44
|
%
|
||||||||||
Severance and restructuring costs
|
1,111
|
9
|
%
|
-
|
0
|
%
|
||||||||||
Acquisition costs
|
64
|
1
|
%
|
396
|
2
|
%
|
||||||||||
23,655
|
24,827
|
|||||||||||||||
LOSS FROM OPERATIONS
|
(11,684
|
)
|
(6,396
|
)
|
||||||||||||
OTHER (EXPENSE) INCOME, NET
|
(1,374
|
)
|
13
|
|||||||||||||
LOSS BEFORE INCOME TAXES
|
(13,058
|
)
|
(109
|
)%
|
(6,383
|
)
|
(35
|
)%
|
||||||||
Income tax benefit
|
(215
|
)
|
(380
|
)
|
||||||||||||
NET LOSS
|
$
|
(12,843
|
)
|
$
|
(6,003
|
)
|
For the Six Months Ended
|
Favorable/(Unfavorable)
|
|||||||||||||||
June 30, 2020
|
June 30, 2019
|
$ Change
|
% Change
|
|||||||||||||
Net product sales
|
$
|
9,508
|
$
|
15,409
|
$
|
(5,901
|
)
|
38.3
|
%
|
|||||||
Less: Cost of product sales
|
10,045
|
(12,002
|
)
|
1,957
|
16.3
|
%
|
||||||||||
Gross product margin
|
$
|
(537
|
)
|
$
|
3,407
|
$
|
(3,944
|
)
|
115.8
|
%
|
||||||
Gross product margin percentage
|
(5.6
|
)%
|
22.1
|
%
|
• |
$1.3 million unfavorable product sales volume as described above, together with
|
• |
$2.6 million unfavorable product margins related to the cost of returned product and product shipped outside the U.S.
|
For the Six Months Ended
|
Favorable/(Unfavorable)
|
|||||||||||||||
June 30, 2020
|
June 30, 2019
|
$ Change
|
% Change
|
|||||||||||||
Clinical and regulatory affairs
|
$
|
500
|
$
|
763
|
$
|
263
|
34.5
|
%
|
||||||||
Other research and development
|
3,381
|
3,555
|
174
|
4.9
|
%
|
|||||||||||
Total Research and Development
|
$
|
3,881
|
$
|
4,318
|
$
|
437
|
10.1
|
%
|
June 30, 2020
|
||||
(in thousands)
|
||||
Cash and cash equivalents
|
$
|
36,427,468
|
||
Accounts receivable, net of allowance for doubtful amounts
|
2,610,587
|
|||
Inventories, net
|
14,131,540
|
|||
Prepaid expenses and other current assets
|
742,908
|
|||
Total current assets
|
53,912,503
|
|||
Less: Total current liabilities
|
14,296,153
|
|||
Working capital
|
$
|
39,616,350
|
ITEM 4. |
CONTROLS AND PROCEDURES
|
(a) |
Disclosure Controls and Procedures. Under the supervision and with the participation of our senior management, consisting of our principal executive officer and our principal financial officer, we conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of the end of the period covered by this report. Based on this evaluation, our management, including our principal executive officer and principal financial officer, concluded that as of June 30, 2020 our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms. Our disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in our Exchange Act reports is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
|
(b) |
Changes in Internal Control over Financial Reporting. There were no changes in our internal control over financial reporting identified in connection with the evaluation required by paragraph (d) of Rule 13a-15 or Rule 15d-15 under the Exchange Act that occurred during the three months ended June 30, 2020, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
|
PART II. |
OTHER INFORMATION
|
ITEM 1. |
LEGAL PROCEEDINGS
|
ITEM 1A. |
RISK FACTORS
|
• |
our ability to compete with companies that are currently in, or may in the future enter, the market for our products;
|
• |
our ability to control costs, including our operating expenses;
|
• |
our ability to successfully expand our business;
|
• |
our ability to meet customer demand;
|
• |
the amount and timing of operating expenses, particularly sales and manufacturing expenses, related to the maintenance and expansion of our business, operations and infrastructure; and
|
• |
general economic and political conditions in our markets.
|
• |
perceptions by members of the health care community, including physicians, about the safety and effectiveness of our products;
|
• |
limitation on use or warnings required by FDA in our product labeling;
|
• |
cost-effectiveness of our products relative to competing products;
|
• |
convenience and ease of administration;
|
• |
potential advantages of alternative treatment methods;
|
• |
availability of reimbursement for our products from government or other healthcare payers; and
|
• |
effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.
|
• |
patent protection;
|
• |
scientific expertise;
|
• |
ability to develop and market products and processes;
|
• |
ability to obtain required regulatory approvals;
|
• |
ability to manufacture cost-effective products that meet applicable regulatory requirements;
|
• |
access to adequate capital; and
|
• |
ability to attract and retain qualified personnel.
|
• |
incur, assume or guarantee additional Indebtedness (as defined in the Credit Agreement);
|
• |
repurchase capital stock;
|
• |
make other restricted payments including, without limitation, 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
|
|
Underwriting Agreement dated May 7, 2020 between Chembio Diagnostics, Inc. and Robert W. Baird & Co. Incorporated, as representative of the several underwriters named therein
|
||
Amendment No. 1, dated June 16, 2020, to the letter agreement dated January 17, 2020 between Chembio Diagnostics, Inc. and Gail S. Page
|
||
Letter agreement dated June 15, 2020 between Chembio Diagnostics, Inc. and Gail S. Page
|
||
Amendment No. 1, dated June 30, 2020, to the letter agreement dated June 15, 2020 between Chembio Diagnostics, Inc. and Gail S. Page
|
||
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
|
Inline XBRL Instance Document
|
|
101.SCH
|
Inline XBRL Taxonomy Extension Schema Document
|
|
101.CAL
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF
|
Inline XBRL Taxonomy Definition Linkbase Document
|
|
101.LAB
|
Inline XBRL Taxonomy Label Linkbase Document
|
|
101.PRE
|
Inline XBRL Taxonomy Presentation Linkbase Document
|
|
104
|
Cover page formatted as Inline XBRL and contained in Exhibit 101
|
† |
Indicates management contract or compensatory plan or arrangement.
|
* |
The certifications attached as Exhibit 32.1 accompany the Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
|
‡ |
Certain sensitive personally identifiable information in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***].
|
|
Chembio Diagnostics, Inc.
|
|
Date: August 7, 2020
|
By: /s/ Richard L. Eberly
|
|
Richard L. Eberly
|
||
Chief Executive Officer and President
|
||
Date: August 7, 2020
|
By: /s / Neil A. Goldman
|
|
Neil A. Goldman
|
||
Chief Financial Officer and Executive Vice President
|
1 Year Chembio Diagnostics Chart |
1 Month Chembio Diagnostics Chart |
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