Nevada
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0-30379
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88-0425691
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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
|
||
Common Stock, $0.01 par value
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CEMI
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The NASDAQ Stock Market LLC
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Item 2.02
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Results of Operations and Financial Condition.
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Item 9.01
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Financial Statements and Exhibits.
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(d)
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Exhibits.
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Exhibit
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Description
|
|
Press release of Chembio Diagnostics, Inc. dated May 4, 2020
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Chembio Diagnostics, Inc.
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||
Dated: May 4, 2020
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By:
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/s/ Neil A. Goldman
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Neil A. Goldman
|
||
Executive Vice President and Chief Financial Officer
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• |
Attained FDA Emergency Use Authorization for the DPP COVID-19 IgM/IgG System serological test
|
o |
Announced the U.S. launch and shipments to customers of the DPP COVID-19 System
|
o |
Selected by Stony Brook Medicine as the testing solution to identify COVID-19 survivors for study on COVID-19 convalescent plasma therapy
|
o |
Received a $4.0 million purchase order from Bio-Manguinhos for our DPP COVID-19 System
|
• |
Completed the reproducibility study and submitted data to the FDA for our DPP HIV-Syphilis test
|
• |
Appointed Richard Eberly as President and Chief Executive Officer and director and appointed Gail Page as Executive Chair of the Board
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• |
Achieved total revenue of $6.9 million and product revenue of $5.7 million
|
For the three months ended
|
||||||||
March 31, 2020
|
March 31, 2019
|
|||||||
REVENUES:
|
||||||||
Net product revenue
|
$
|
5,716,593
|
$
|
6,624,285
|
||||
R&D and grant revenue
|
907,687
|
1,701,789
|
||||||
License and royalty revenue
|
235,304
|
216,191
|
||||||
TOTAL REVENUES
|
6,859,584
|
8,542,265
|
||||||
COSTS AND EXPENSES:
|
||||||||
Cost of product revenue
|
4,374,442
|
5,011,636
|
||||||
Research and development expenses
|
1,958,853
|
2,217,632
|
||||||
Selling, general and administrative expenses
|
4,156,641
|
4,013,071
|
||||||
Severance and related costs
|
723,118
|
-
|
||||||
Acquisition costs
|
63,497
|
395,612
|
||||||
11,276,551
|
11,637,951
|
|||||||
LOSS FROM OPERATIONS
|
(4,416,967
|
)
|
(3,095,686
|
)
|
||||
OTHER INCOME:
|
||||||||
Interest (expense) income, net
|
(662,141
|
)
|
6,684
|
|||||
LOSS BEFORE INCOME TAXES
|
(5,079,108
|
)
|
(3,089,002
|
)
|
||||
Income tax (benefit)
|
(79,559
|
)
|
(272,469
|
)
|
||||
NET LOSS
|
$
|
(4,999,549
|
)
|
$
|
(2,816,533
|
)
|
||
Basic and Diluted loss per share
|
$
|
(0.29
|
)
|
$
|
(0.16
|
)
|
||
Weighted-average number of shares outstanding, basic
|
17,197,301
|
17,166,459
|
||||||
Weighted-average number of shares outstanding, diluted
|
17,197,301
|
17,166,459
|
(Unaudited)
March 31, 2020
|
December 31, 2019
|
|||||||
- ASSETS -
|
||||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
$
|
11,238,017
|
$
|
18,271,352
|
||||
Accounts receivable, net
|
4,877,842
|
3,661,325
|
||||||
Inventories, net
|
10,930,159
|
9,598,030
|
||||||
Prepaid expenses and other current assets
|
798,228
|
693,013
|
||||||
TOTAL CURRENT ASSETS
|
27,844,246
|
32,223,720
|
||||||
FIXED ASSETS:
|
||||||||
Property, plant and equipment, net
|
6,659,279
|
5,933,569
|
||||||
Finance lease right-of-use asset
|
226,305
|
210,350
|
||||||
TOTAL FIXED ASSETS, net
|
6,885,584
|
6,143,919
|
||||||
OTHER ASSETS:
|
||||||||
Operating lease right-of-use asset, net
|
6,785,668
|
7,030,744
|
||||||
Intangible assets, net
|
3,655,858
|
3,914,352
|
||||||
Goodwill
|
5,493,045
|
5,872,690
|
||||||
Deposits and other assets
|
528,261
|
543,539
|
||||||
TOTAL ASSETS
|
$
|
51,192,662
|
$
|
55,728,964
|
||||
- LIABILITIES AND STOCKHOLDERS’ EQUITY -
|
||||||||
CURRENT LIABILITIES:
|
||||||||
Accounts payable and accrued liabilities
|
$
|
6,536,134
|
$
|
5,526,243
|
||||
Deferred revenue
|
543,345
|
125,000
|
||||||
Note payable
|
112,928
|
180,249
|
||||||
Finance lease liabilities
|
47,192
|
41,894
|
||||||
Operating lease liabilities
|
766,896
|
568,294
|
||||||
TOTAL CURRENT LIABILITIES
|
8,006,495
|
6,441,680
|
||||||
OTHER LIABILITIES:
|
||||||||
Long-term operating lease liabilities
|
6,770,005
|
6,969,603
|
||||||
Long-term finance lease liabilities
|
184,095
|
171,953
|
||||||
Long-Term debt, less current portion, and debt discount and issuance costs
|
17,771,268
|
17,644,149
|
||||||
Deferred tax liability
|
327,542
|
466,326
|
||||||
TOTAL LIABILITIES
|
33,059,405
|
31,693,711
|
||||||
STOCKHOLDERS’ EQUITY:
|
||||||||
Preferred stock – 10,000,000 shares authorized, none outstanding
|
-
|
-
|
||||||
Common stock - $0.01 par value; 100,000,000 shares authorized, 17,327,235 shares and 17,733,617 shares issued at March 31, 2020 and December 31, 2019, respectively
|
173,272
|
177,335
|
||||||
Additional paid-in capital
|
95,543,043
|
95,433,077
|
||||||
Accumulated deficit
|
(76,584,552
|
)
|
(71,585,003
|
)
|
||||
Treasury Stock, 31,486 shares at cost
|
(145,056
|
)
|
-
|
|||||
Accumulated other comprehensive (loss) income
|
(853,450
|
)
|
9,844
|
|||||
TOTAL STOCKHOLDERS’ EQUITY
|
18,133,257
|
24,035,253
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
51,192,662
|
$
|
55,728,964
|
||||
For the three months ended
|
||||||||
March 31, 2020
|
March 31, 2019
|
|||||||
Net cash used in operating activities
|
$
|
(5,651,960
|
)
|
$
|
(4,754,878
|
)
|
||
Net cash used in investing activities
|
(1,078,271
|
)
|
(577,472
|
)
|
||||
Net cash provided by financing activities
|
(223,290
|
)
|
(29,930
|
)
|
||||
Effect of exchange rate changes on cash
|
(79,814
|
)
|
208,407
|
|||||
DECREASE IN CASH AND CASH EQUIVALENTS
|
(7,033,335
|
)
|
(5,153,873
|
)
|
||||
Cash and cash equivalents - beginning of the period
|
18,271,352
|
12,524,551
|
||||||
Cash and cash equivalents - end of the period
|
$
|
11,238,017
|
$
|
7,370,678
|