|
|
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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.
|
Item 9.01 |
Financial Statements and Exhibits.
|
(d)
|
Exhibits.
|
Exhibit No.
|
Description
|
||
Press release of Chembio Diagnostics, Inc., dated May 6, 2021
|
|||
104
|
Cover Page Interactive Data File (embedded within the Inline XBRL document)
|
Chembio Diagnostics, Inc.
|
||
Dated: May 6, 2021
|
By:
|
/s/ Richard L. Eberly
|
Chief Executive Officer and President
|
• |
Launched marketing programs with national distribution partners in the U.S to promote and supply the rapid DPP HIV-Syphilis test system across decentralized healthcare markets
|
• |
Completed registrations in and received initial purchase orders for shipment to multiple countries in Africa and Southeast Asia for the World Health Organization prequalified SURE
CHECK HIV Self-Test
|
• |
Completed milestones resulting in the recognition of $3.4 million of revenue in the first quarter as part of the $12.7 million BARDA award for the development and issuance of an
Emergency Use Authorization (EUA) application for the DPP Respiratory Panel and the development and receipt of 510(k) clearance for the rapid, point-of-care DPP SARS-CoV-2 Antigen test system
|
• |
Continued the close collaboration with BARDA under the $628,000 award in pursuit of an EUA for the DPP SARS-CoV-2 Antigen test system
|
• |
Received regulatory approval for the DPP SARS-CoV-2 Antigen test system from Agência Nacional de Vigilância Sanitária (ANVISA), Brazil’s health regulatory agency, in collaboration
with Bio-Manguinhos, a subsidiary of the Oswaldo Cruz Foundation that is responsible for the development and production of vaccines, diagnostics and biopharmaceuticals,
primarily to meet demands of Brazil’s national public health system
|
• |
Initiated U.S. distribution of the in-licensed rapid, point-of-care, EUA approved Status COVID-19/Flu A&B test that is sourced from a third party
|
For the three months ended
|
||||||||
March 31, 2021
|
March 31, 2020
|
|||||||
REVENUES:
|
||||||||
Product revenue
|
$
|
4,024,662
|
$
|
5,716,593
|
||||
R&D revenue
|
1,106,639
|
907,687
|
||||||
Government grant income
|
3,350,000
|
-
|
||||||
License and royalty revenue
|
243,058
|
235,304
|
||||||
TOTAL REVENUES
|
8,724,359
|
6,859,584
|
||||||
COSTS AND EXPENSES:
|
||||||||
Cost of product revenue
|
3,548,441
|
4,374,442
|
||||||
Research and development expenses
|
2,863,338
|
1,958,853
|
||||||
Selling, general and administrative expenses
|
6,085,067
|
4,156,641
|
||||||
Severance, restructuring and other related costs
|
83,087
|
723,118
|
||||||
Acquisition costs
|
-
|
63,497
|
||||||
12,579,933
|
11,276,551
|
|||||||
LOSS FROM OPERATIONS
|
(3,855,574
|
)
|
(4,416,967
|
)
|
||||
OTHER EXPENSE:
|
||||||||
Interest expense, net
|
(712,477
|
)
|
(662,141
|
)
|
||||
LOSS BEFORE INCOME TAXES
|
(4,568,051
|
)
|
(5,079,108
|
)
|
||||
Income tax benefit
|
67,888
|
79,559
|
||||||
NET LOSS
|
$
|
(4,500,163
|
)
|
$
|
(4,999,549
|
)
|
||
Basic and diluted loss per share
|
$
|
(0.22
|
)
|
$
|
(0.29
|
)
|
||
Weighted average number of shares outstanding, basic and diluted
|
20,163,386
|
17,197,301
|
(Unaudited)
March 31, 2021
|
December 31, 2020
|
|||||||
- ASSETS -
|
||||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
$
|
14,350,953
|
$
|
23,066,301
|
||||
Accounts receivable, net of allowance for doubtful accounts of $354,528 and $296,793 as of March 31,
2021 and December 31, 2020, respectively
|
2,413,552
|
3,377,387
|
||||||
Inventories, net
|
14,690,627
|
12,516,402
|
||||||
Prepaid expenses and other current assets
|
812,638
|
778,683
|
||||||
TOTAL CURRENT ASSETS
|
32,267,770
|
39,738,773
|
||||||
FIXED ASSETS:
|
||||||||
Property, plant and equipment, net
|
9,582,872
|
8,688,403
|
||||||
Finance lease right-of-use asset, net
|
217,376
|
233,134
|
||||||
TOTAL FIXED ASSETS, net
|
9,800,248
|
8,921,537
|
||||||
OTHER ASSETS:
|
||||||||
Operating lease right-of-use assets, net
|
5,904,299
|
6,112,632
|
||||||
Intangible assets, net
|
3,377,003
|
3,645,986
|
||||||
Goodwill
|
5,689,315
|
5,963,744
|
||||||
Deposits and other assets
|
374,862
|
509,342
|
||||||
TOTAL ASSETS
|
$
|
57,413,497
|
$
|
64,892,014
|
||||
- LIABILITIES AND STOCKHOLDERS’ EQUITY -
|
||||||||
CURRENT LIABILITIES:
|
||||||||
Accounts payable and accrued liabilities
|
$
|
8,396,994
|
$
|
10,042,790
|
||||
Deferred revenue
|
404,486
|
1,606,997
|
||||||
Operating lease liabilities
|
572,478
|
642,460
|
||||||
Finance lease liabilities
|
60,064
|
58,877
|
||||||
TOTAL CURRENT LIABILITIES
|
9,434,022
|
12,351,124
|
||||||
OTHER LIABILITIES:
|
||||||||
Long-term operating lease liabilities
|
6,197,527
|
6,327,143
|
||||||
Long-term finance lease liabilities
|
169,765
|
185,239
|
||||||
Long-term debt, net
|
18,327,037
|
18,182,158
|
||||||
Deferred tax liability
|
-
|
69,941
|
||||||
TOTAL LIABILITIES
|
34,128,351
|
37,115,605
|
||||||
STOCKHOLDERS’ EQUITY:
|
||||||||
Preferred stock – 10,000,000 shares authorized, none outstanding
|
-
|
-
|
||||||
Common stock - $0.01 par value; 100,000,000 shares authorized; 20,285,695 shares and 20,223,498
shares issued at March 31, 2021 and December 31, 2020, respectively
|
202,857
|
202,235
|
||||||
Additional paid-in capital
|
125,425,514
|
124,961,514
|
||||||
Accumulated deficit
|
(101,606,494
|
)
|
(97,106,331
|
)
|
||||
Treasury stock 41,141 shares at cost as of March 31, 2021 and December 31, 2020, respectively
|
(190,093
|
)
|
(190,093
|
)
|
||||
Accumulated other comprehensive (loss) income
|
(546,638
|
)
|
(90,916
|
)
|
||||
TOTAL STOCKHOLDERS’ EQUITY
|
23,285,146
|
27,776,409
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
57,413,497
|
$
|
64,892,014
|
March 31, 2021
|
March 31, 2020
|
|||||||
Net cash used in operating activities
|
$
|
(7,261,260
|
)
|
$
|
(5,651,960
|
)
|
||
Net cash used in investing activities
|
(1,239,168
|
)
|
(1,078,271
|
)
|
||||
Net cash used by financing activities
|
(129,341
|
)
|
(223,290
|
)
|
||||
Effect of exchange rate changes on cash
|
(85,579
|
)
|
(79,814
|
)
|
||||
INCREASE IN CASH AND CASH EQUIVALENTS
|
(8,715,348
|
)
|
(7,033,335
|
)
|
||||
Cash and cash equivalents - beginning of the period
|
23,066,301
|
18,271,352
|
||||||
Cash and cash equivalents - end of the period
|
$
|
14,350,953
|
$
|
11,238,017
|