Nevada
|
0-30379
|
88-0425691
|
(State or Other Jurisdiction of Incorporation or Organization)
|
(Commission File Number)
|
(I.R.S. Employer Identification No.)
|
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
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
|
Item 2.02 |
Results of Operations and Financial Condition.
|
Item 9.01 |
Financial Statements and Exhibits.
|
(d)
|
Exhibit
|
Exhibit No.
|
Description
|
||
Press release of Chembio Diagnostics, Inc., dated August 6, 2020
|
Chembio Diagnostics, Inc.
|
||
Dated: August 6, 2020
|
By:
|
/s/ Richard L. Eberly
|
Chief Executive Officer and President
|
• |
Announced plans to seek U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) approval for a revised DPP COVID-19 IgM/IgG System in the third quarter and
subsequently for the DPP COVID-19 Antigen System
|
• |
Awarded BARDA contract for $628,071 to assist in the development of, and an EUA application for, a DPP COVID-19 Antigen System
|
• |
Received FDA 510(k) clearance for DPP Zika IgM System, including the first FDA approval for the company’s Micro Reader
|
• |
Received $1.5 million order from UNICEF for additional multiplex DPP Zika, Chikungunya and Dengue Systems
|
• |
Strengthened the balance sheet with $28.4 million of net proceeds raised in a public offering of common stock
|
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
|
$
|
15,409,336
|
||||||||
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
|
18,430,411
|
||||||||||||
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
|
12,891,187
|
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 and diluted loss per share
|
$
|
(0.42
|
)
|
$
|
(0.19
|
)
|
$
|
(0.71
|
)
|
$
|
(0.36
|
)
|
||||
Weighted average number of shares outstanding, basic and diluted
|
18,868,144
|
16,914,171
|
18,032,723
|
16,906,936
|
(Unaudited)
|
||||||||
June 30, 2020
|
December 31, 2019
|
|||||||
- ASSETS -
|
||||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
$
|
36,427,468
|
$
|
18,271,352
|
||||
Accounts receivable, net of allowance for doubtful accounts of $156,000 and $62,000 as of June 30, 2020
and December 31, 2019, respectively
|
2,610,587
|
3,661,325
|
||||||
Inventories, net
|
14,131,540
|
9,598,030
|
||||||
Prepaid expenses and other current assets
|
742,908
|
693,013
|
||||||
TOTAL CURRENT ASSETS
|
53,912,503
|
32,223,720
|
||||||
FIXED ASSETS:
|
||||||||
Property, Plant and Equipment, net
|
7,705,890
|
5,933,569
|
||||||
Finance lease right-of-use asset, net
|
258,884
|
210,350
|
||||||
TOTAL FIXED ASSETS, net
|
7,964,774
|
6,143,919
|
||||||
OTHER ASSETS:
|
||||||||
Operating lease right-of-use assets, net
|
6,515,282
|
7,030,744
|
||||||
Intangible assets, net
|
3,605,194
|
3,914,352
|
||||||
Goodwill
|
5,534,624
|
5,872,690
|
||||||
Deposits and other assets
|
429,884
|
543,539
|
||||||
TOTAL ASSETS
|
$
|
77,962,261
|
$
|
55,728,964
|
||||
- LIABILITIES AND STOCKHOLDERS’ EQUITY -
|
||||||||
CURRENT LIABILITIES:
|
||||||||
Accounts payable and accrued liabilities
|
$
|
9,290,887
|
$
|
5,526,243
|
||||
Deferred revenue
|
4,097,155
|
125,000
|
||||||
Finance lease liabilities
|
55,712
|
41,894
|
||||||
Operating lease liabilities
|
776,691
|
568,294
|
||||||
Note payable
|
75,708
|
180,249
|
||||||
TOTAL CURRENT LIABILITIES
|
14,296,153
|
6,441,680
|
||||||
OTHER LIABILITIES:
|
||||||||
Long-term operating lease liabilities
|
6,565,019
|
6,969,603
|
||||||
Long-term finance lease liabilities
|
210,408
|
171,953
|
||||||
Long-term debt, less current portion, net
|
17,903,401
|
17,644,149
|
||||||
Deferred tax liability
|
250,326
|
466,326
|
||||||
TOTAL LIABILITIES
|
39,225,307
|
25,252,031
|
||||||
STOCKHOLDERS’ EQUITY:
|
||||||||
Preferred stock – 10,000,000 shares authorized, none outstanding
|
-
|
-
|
||||||
Common stock - $0.01 par value; 100,000,000 shares authorized; 20,194,832 shares and 17,733,617 shares
issued at June 30, 2020 and December 31, 2019, respectively
|
201,948
|
177,335
|
||||||
Additional paid-in capital
|
124,143,171
|
95,433,077
|
||||||
Accumulated deficit
|
(84,428,349
|
)
|
(71,585,003
|
)
|
||||
Treasury stock 33,290 and 0 shares at cost as of June 30, 2020 and December 31, 2019, respectively
|
(150,919
|
)
|
-
|
|||||
Accumulated other comprehensive (loss) income
|
(1,028,897
|
)
|
9,844
|
|||||
TOTAL STOCKHOLDERS’ EQUITY
|
38,736,954
|
24,035,253
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
77,962,261
|
$
|
55,728,964
|
For The Six Months Ended
|
||||||||
June 30, 2020
|
June 30, 2019
|
|||||||
Net cash used in operating activities
|
$
|
(7,330,984
|
)
|
$
|
(7,086,415
|
)
|
||
Net cash used in investing activities
|
(2,449,346
|
)
|
(1,003,738
|
)
|
||||
Net cash provided (used in) by financing activities
|
27,965,541
|
(92,158
|
)
|
|||||
Effect of exchange rate changes on cash
|
(29,095
|
)
|
161,835
|
|||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
18,156,116
|
(8,020,476
|
)
|
|||||
Cash and cash equivalents - beginning of the period
|
18,271,352
|
12,524,551
|
||||||
Cash and cash equivalents - end of the period
|
$
|
36,427,468
|
$
|
4,504,075
|