Nevada |
0-30379 | 88-0425691 |
(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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☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐
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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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☐
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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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Item 2.02 |
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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Exhibit
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Description
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Press release of Chembio Diagnostics, Inc. dated March 12, 2020 with respect to financial results for the quarter and fiscal year ended December 31, 2019
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Dated: March 13, 2020 |
Chembio Diagnostics, Inc.
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|
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By: | /s/ Neil A. Goldman |
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Neil A. Goldman |
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Executive Vice President and Chief Financial Officer |
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|
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● |
Achieved full year 2019 product revenue of $28.8 million and total revenue of $34.5 million, an increase of 3.3% and decrease of 0.3%, respectively compared to 2018
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● |
Achieved fourth quarter 2019 product revenue of $5.5 million and total revenue of $6.9 million representing a decrease of 5.9% and 11.8%, respectively, compared to the prior year period
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● |
Announced a worldwide strategic partnership with LumiraDx to develop and commercialize COVID-19 tests on the DPP and LumiraDX platforms
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● |
Appointed Richard Eberly as Chief Executive Officer
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● |
Received $1.5 million dollar UNICEF order for Multiplex Zika Systems
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● |
Completed acquisition of Orangelife to diversify and expand our market penetration in Brazil and support Bio-Manguinhos, one of our major customers
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● |
Received WHO Prequalification approval for both the HIV Self-Test and the Malaysia production facility
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● |
Initiated production on our fully automated DPP manufacturing line and took delivery of our second and third automated lines for our other product platforms
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● |
Continued collaborative work with the FDA on reproducibility study requirements for the HIV-Syphilis System PMA following acceptance of the syphilis and pregnant women data
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For the twelve months ended
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||||||||
December 31,
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December 31,
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|||||||
2019
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2018
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|||||||
REVENUES:
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||||||||
Net product sales
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$
|
28,844,997
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$
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27,913,209
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||||
R&D and grant revenue
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4,680,282
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5,719,458
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||||||
License and royalty revenue
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938,753
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948,773
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||||||
TOTAL REVENUES
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34,464,032
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34,581,440
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||||||
COSTS AND EXPENSES:
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||||||||
Cost of product sales
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22,394,317
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22,599,432
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||||||
Research and development expenses
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8,538,416
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8,526,256
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||||||
Selling, general and administrative expenses
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16,138,424
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11,100,775
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||||||
Acquisition costs
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721,465
|
337,645
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||||||
47,792,622
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42,564,108
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|||||||
LOSS FROM OPERATIONS
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(13,328,590
|
)
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(7,982,668
|
)
|
||||
OTHER INCOME:
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||||||||
Interest (expense) income, net
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(846,831
|
)
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49,498
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|||||
LOSS BEFORE INCOME TAXES
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(14,175,421
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)
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(7,933,170
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)
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||||
Income tax benefit
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500,292
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67,521
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||||||
NET LOSS
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$
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(13,675,129
|
)
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$
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(7,865,649
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)
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||
Basic and Diluted loss per share
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$
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(0.81
|
)
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$
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(0.54
|
)
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||
Weighted average number of shares outstanding, basic
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16,954,142
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14,432,505
|
||||||
Weighted average number of shares outstanding, diluted
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16,954,142
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14,432,505
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- ASSETS -
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December 31,
2019
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December 31,
2018
|
||||||
CURRENT ASSETS:
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||||||||
Cash and cash equivalents
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$
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18,271,352
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$
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12,524,551
|
||||
Accounts receivable, net
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3,661,325
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7,373,971
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||||||
Inventories, net
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9,598,030
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7,851,222
|
||||||
Prepaid expenses and other current assets
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693,013
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702,010
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||||||
TOTAL CURRENT ASSETS
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32,223,720
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28,451,754
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||||||
FIXED ASSETS:
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||||||||
Property, plant and equipment, net
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5,933,569
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2,873,920
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||||||
Finance lease right-of-use asset
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210,350
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-
|
||||||
TOTAL FIXED ASSETS, net
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6,143,919
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2,873,920
|
||||||
OTHER ASSETS:
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||||||||
Operating lease right-of-use asset
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7,030,744
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-
|
||||||
Intangible assets, net
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3,914,352
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3,884,831
|
||||||
Goodwill
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5,872,690
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4,983,127
|
||||||
Deposits and other assets
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543,539
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717,551
|
||||||
TOTAL ASSETS
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$
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55,728,964
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$
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40,911,183
|
||||
- LIABILITIES AND STOCKHOLDERS’ EQUITY -
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||||||||
CURRENT LIABILITIES:
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||||||||
Accounts payable and accrued liabilities
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$
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5,526,243
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$
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5,888,681
|
||||
Deferred revenue
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125,000
|
422,905
|
||||||
Note payable
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180,249
|
207,694
|
||||||
Finance lease liability
|
41,894
|
-
|
||||||
Operating lease liability
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568,294
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-
|
||||||
TOTAL CURRENT LIABILITIES
|
6,441,680
|
6,519,280
|
||||||
OTHER LIABILITIES:
|
||||||||
Long-term operating lease liabilities
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6,969,603
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-
|
||||||
Long-term finance lease liabilities
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171,953
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-
|
||||||
Long-Term debt net of debt discount and issuance costs
|
17,644,149
|
171,821
|
||||||
Deferred tax liability
|
466,326
|
892,308
|
||||||
TOTAL LIABILITIES
|
31,693,711
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7,583,409
|
||||||
STOCKHOLDERS’ EQUITY:
|
||||||||
Preferred stock – 10,000,000 shares authorized, none outstanding Common stock - $.01 par value; 100,000,000 shares
|
-
|
-
|
||||||
authorized, 17,733,617 and 17,166,459 shares issued and
|
||||||||
outstanding at December 31, 2019 and 2018, respectively
|
177,335
|
171,664
|
||||||
Additional paid-in capital
|
95,433,077
|
90,953,788
|
||||||
Accumulated deficit
|
(71,585,003
|
)
|
(57,909,874
|
)
|
||||
Accumulated other comprehensive income
|
9,844
|
112,196
|
||||||
TOTAL STOCKHOLDERS’ EQUITY
|
24,035,253
|
33,327,774
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
55,728,964
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$
|
40,911,183
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For the twelve months ended
|
||||||||
December 31,
2019
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December 31,
2018
|
|||||||
Net cash used in operating activities
|
$
|
(9,055,506
|
)
|
$
|
(11,781,441
|
)
|
||
Net cash used in investing activities
|
(3,753,786
|
)
|
(6,958,396
|
)
|
||||
Net cash provided by financing activities
|
18,494,476
|
27,483,693
|
||||||
Effect of exchange rate changes on cash
|
61,617
|
(9,607
|
)
|
|||||
INCREASE IN CASH AND CASH EQUIVALENTS
|
5,746,801
|
8,734,249
|
||||||
Cash and cash equivalents - beginning of the period
|
12,524,551
|
3,790,302
|
||||||
Cash and cash equivalents - end of the period
|
$
|
18,271,352
|
$
|
12,524,551
|