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(State or Other Jurisdiction of Incorporation or Organization)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading Symbol
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Name of each exchange on which registered
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Item 2.02 |
Results of Operations and Financial Condition.
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Item 9.01 |
Financial Statements and Exhibits.
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Exhibit No.
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Description
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|
Press Release of Chembio Diagnostics, Inc., dated August 4, 2022
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||
104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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Chembio Diagnostics, Inc.
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||
Dated: August 4, 2022
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By:
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/s/ Richard L. Eberly
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Chief Executive Officer and President
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• |
Achieved second quarter 2022 total revenue of $9.2 million including product revenue of $8.9 million, representing growth of 42% and 125%, respectively, compared to the prior year
period:
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o |
U.S. product revenue of $3.4 million, representing growth of 208% compared to the prior year period
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o |
Africa product revenue of $3.1 million, representing growth of 114% compared to the prior year period
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• |
Completed manufacturing and most of the shipments under the $4 million HIV test purchase order supported by The Global Fund
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• |
Broadened relationship with Reszon Diagnostics International to manufacture HIV1/2 STAT-PAK in the Chembio Diagnostics Malaysia facility and to increase commercial presence in the
Asia-Pacific region
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• |
Expanded Direct-to-Consumer channel for the commercialization of the Sure Check HIV Self-test in Brazil and the United Kingdom, and the third-party SCoV-2 Ag Detect Self-Test in
the United States
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• |
Improved cash usage in the second quarter of 2022 to $1.6 million, from $8.8 million in the prior year period and $4.4 million in the preceding quarter, with a cash and cash
equivalents balance as of June 30, 2022 of $22.8 million
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•
|
Focus on higher margin business in growth markets
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•
|
Lower manufacturing costs
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•
|
Reduce infrastructure costs
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•
|
Strategic review of non-core businesses and assets
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•
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The ongoing healthcare and economic impacts of COVID-19 on the global customer base for the Company’s non‑COVID-19 products continue to
negatively affect the timing and rate of recovery of the Company’s revenues from those products.
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•
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Although the Company has entered into agreements to distribute third-party COVID-19 products in the United States, its ability to sell those
products could be constrained because of staffing and supply chain limitations affecting the suppliers of those products.
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For the three months ended
(Unaudited)
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For the six months ended
(Unaudited)
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|||||||||||||||
June 30, 2022
|
June 30, 2021
|
June 30, 2022
|
June 30, 2021
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|||||||||||||
REVENUES:
|
||||||||||||||||
Product revenue
|
$
|
8,858,146
|
$
|
3,931,383
|
$
|
27,385,602
|
$
|
7,956,045
|
||||||||
R&D revenue
|
8,046
|
727
|
26,219
|
1,107,366
|
||||||||||||
Government grant income
|
-
|
2,280,000
|
-
|
5,630,000
|
||||||||||||
License and royalty revenue
|
295,238
|
250,000
|
566,220
|
493,058
|
||||||||||||
TOTAL REVENUES
|
9,161,430
|
6,462,110
|
27,978,041
|
15,186,469
|
||||||||||||
COSTS AND EXPENSES:
|
||||||||||||||||
Cost of product revenue
|
8,086,849
|
4,039,696
|
23,310,710
|
7,588,137
|
||||||||||||
Research and development expenses
|
2,042,351
|
2,796,981
|
3,696,057
|
5,660,319
|
||||||||||||
Selling, general and administrative expenses
|
5,249,980
|
6,001,353
|
12,196,250
|
12,086,422
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||||||||||||
Impairment, restructuring, severance and related costs
|
-
|
1,961,156
|
3,043,179
|
2,044,243
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||||||||||||
TOTAL COSTS AND EXPENSES
|
15,379,180
|
14,799,186
|
42,246,196
|
27,379,121
|
||||||||||||
LOSS FROM OPERATIONS
|
(6,217,750
|
)
|
(8,337,076
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)
|
(14,268,155
|
)
|
(12,192,652
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)
|
||||||||
OTHER EXPENSE:
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||||||||||||||||
Interest expense, net
|
(728,414
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)
|
(727,374
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)
|
(1,461,976
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)
|
(1,439,851
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)
|
||||||||
LOSS BEFORE INCOME TAXES
|
(6,946,164
|
)
|
(9,064,450
|
)
|
(15,730,131
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)
|
(13,632,503
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)
|
||||||||
Income tax (provision) benefit
|
(279
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)
|
65
|
(6,606
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)
|
67,955
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||||||||||
NET LOSS
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$
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(6,946,443
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)
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$
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(9,064,385
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)
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$
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(15,736,737
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)
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$
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(13,564,548
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)
|
||||
Basic and diluted loss per share
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$
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(0.23
|
)
|
$
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(0.45
|
)
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$
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(0.52
|
)
|
$
|
(0.67
|
)
|
||||
Weighted average number of shares outstanding, basic and diluted
|
30,222,758
|
20,219,617
|
30,156,768
|
20,191,657
|
(Unaudited)
June 30, 2022
|
December 31, 2021
|
|||||||
- ASSETS -
|
||||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
$
|
22,837,453
|
$
|
28,772,892
|
||||
Accounts receivable, net of allowance for doubtful accounts of $242,671 and $243,042 as of June 30, 2022
and December 31, 2021, respectively
|
4,255,944
|
11,441,107
|
||||||
Inventories, net
|
11,308,660
|
12,920,451
|
||||||
Prepaid expenses and other current assets
|
2,498,447
|
2,096,399
|
||||||
TOTAL CURRENT ASSETS
|
40,900,504
|
55,230,849
|
||||||
FIXED ASSETS:
|
||||||||
Property, Plant and Equipment, net
|
8,843,954
|
8,556,773
|
||||||
Finance lease right-of-use asset, net
|
172,676
|
191,870
|
||||||
TOTAL FIXED ASSETS, net
|
9,016,630
|
8,748,643
|
||||||
OTHER ASSETS:
|
||||||||
Operating lease right-of-use assets, net
|
5,841,382
|
5,891,906
|
||||||
Intangible assets, net
|
||||||||
Goodwill
|
3,022,787
|
|||||||
Deposits and other assets
|
297,024
|
358,010
|
||||||
TOTAL ASSETS
|
$
|
56,055,540
|
$
|
73,252,195
|
||||
- LIABILITIES AND STOCKHOLDERS’ EQUITY -
|
||||||||
CURRENT LIABILITIES:
|
||||||||
Accounts payable and accrued liabilities
|
$
|
10,051,649
|
$
|
13,127,993
|
||||
Deferred revenue
|
||||||||
Operating lease liabilities
|
905,516
|
886,294
|
||||||
Finance lease liabilities
|
73,724
|
68,176
|
||||||
Current portion of long-term debt
|
3,000,000
|
1,200,000
|
||||||
TOTAL CURRENT LIABILITIES
|
14,030,889
|
15,282,463
|
||||||
OTHER LIABILITIES:
|
||||||||
Long-term operating lease liabilities
|
5,877,063
|
5,976,151
|
||||||
Long-term finance lease liabilities
|
115,943
|
139,678
|
||||||
Long-term debt, net
|
16,126,833
|
17,589,003
|
||||||
TOTAL LIABILITIES
|
36,150,728
|
38,987,295
|
||||||
STOCKHOLDERS’ EQUITY:
|
||||||||
Preferred stock – 10,000,000 shares authorized, none issued or outstanding
|
-
|
-
|
||||||
Common stock - $0.01 par value; 100,000,000 shares authorized; 30,086,283 shares and 20,223,498 shares
issued at June 30, 2022 and December 31, 2021, respectively
|
302,727
|
301,050
|
||||||
Additional paid-in capital
|
167,041,203
|
165,772,636
|
||||||
Accumulated deficit
|
(146,746,597
|
)
|
(131,009,860
|
)
|
||||
Treasury stock 41,141 shares at cost as of June 30, 2022 and December 31, 2021, respectively
|
(206,554
|
)
|
(206,554
|
)
|
||||
Accumulated other comprehensive loss
|
(485,967
|
)
|
(592,372
|
)
|
||||
TOTAL STOCKHOLDERS’ EQUITY
|
19,904,812
|
34,264,900
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
56,055,540
|
$
|
73,252,195
|
June 30
2022
|
June 30
2021
|
|||||||
Net cash used in operating activities
|
(4,802,145
|
)
|
(15,908,660
|
)
|
||||
Net cash used in investing activities
|
(1,135,332
|
)
|
(1,299,012
|
)
|
||||
Net cash provided by financing activities
|
(74,089
|
)
|
(69,488
|
)
|
||||
Effect of exchange rate changes on cash
|
76,127
|
|
(144,947
|
)
|
||||
DECREASE IN CASH AND CASH EQUIVALENTS
|
(5,935,439
|
)
|
(17,422,107
|
)
|
||||
Cash and cash equivalents - beginning of the period
|
28,772,892
|
23,066,301
|
||||||
Cash and cash equivalents - end of the period
|
$
|
22,837,453
|
$
|
5,644,194
|