|
|
|
(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
|
||
|
|
Item 2.02 |
Results of Operations and Financial Condition.
|
Item 9.01 |
Financial Statements and Exhibits.
|
Exhibit No.
|
Description
|
|
Press release of Chembio Diagnostics, Inc., dated March 11, 2021
|
||
104
|
Cover Page Interactive Data File (embedded within the Inline XBRL document)
|
Chembio Diagnostics, Inc.
|
||
Dated: March 11, 2021
|
By:
|
/s/ Richard L. Eberly
|
Chief Executive Officer and President
|
• |
Achieved fourth quarter 2020 total revenue of $10.2 million and product revenue of $6.9 million, representing growth of 62% and 39%, respectively, compared to the prior year period
|
• |
Received FDA Premarket Application (PMA) approval for the DPP HIV-Syphilis test
|
• |
Expanded manufacturing capabilities by validating and implementing automated lines
|
• |
Received notice in January 2021 that the FDA was declining to review the DPP SARS-CoV-2 Antigen test system based on its updated prioritization guidance, under which review of the
system was not a priority. The FDA supplementally advised on the type and nature of information it would need to receive in a subsequent EUA application in order for the DPP SARS-CoV-2 Antigen test system to be prioritized for review.
|
• |
Signed an in-licensing agreement to distribute a, point-of-care, EUA approved, respiratory panel for the detection of SARS-CoV-2 Antigens, Flu A and Flu B in the U.S., which is
scheduled to launch in March.
|
• |
Obtained CE mark for the DPP SARS-CoV-2 Antigen test system and the DPP SARS-CoV-2 IgM/IgG antibody test system.
|
• |
Received ANVISA approval for the DPP SARS-CoV-2 Antigen test system through our subsidiary in Brazil.
|
• |
Awarded $12.7 million by Biomedical Advanced Research and Development Authority (BARDA) for the development and issuance of an Emergency Use Authorization (EUA) application for the
DPP Respiratory Antigen Panel and the preparation and receipt of 510(k) clearance for the rapid DPP SARS-CoV-2 Antigen System.
|
For the three months ended
(Unaudited)
|
For the year ended
|
|||||||||||||||
Dec. 31, 2020
|
Dec. 31, 2019
|
Dec. 31, 2020
|
Dec. 31, 2019
|
|||||||||||||
REVENUES:
|
||||||||||||||||
Net product sales
|
$
|
6,852,526
|
$
|
4,925,043
|
$
|
24,767,149
|
$
|
28,844,997
|
||||||||
R&D
|
1,095,402
|
1,152,249
|
4,851,562
|
4,025,538
|
||||||||||||
Government Grants
|
2,018,924
|
-
|
2,018,924
|
654,744
|
||||||||||||
License and royalty revenue
|
260,112
|
235,401
|
832,562
|
938,753
|
||||||||||||
TOTAL REVENUES
|
10,226,964
|
6,312,693
|
32,470,197
|
34,464,032
|
||||||||||||
COSTS AND EXPENSES:
|
||||||||||||||||
Cost of product sales
|
6,361,480
|
3,743,592
|
23,874,487
|
22,394,317
|
||||||||||||
Research and development expenses
|
3,275,455
|
1,995,826
|
9,508,494
|
8,538,416
|
||||||||||||
Selling, general and administrative expenses
|
7,134,593
|
3,572,823
|
21,037,701
|
16,138,424
|
||||||||||||
Severance, restructuring and other related costs
|
-
|
-
|
1,122,310
|
-
|
||||||||||||
Acquisition Costs
|
-
|
325,852
|
63,497
|
721,465
|
||||||||||||
16,771,528
|
9,638,093
|
55,606,489
|
47,792,622
|
|||||||||||||
LOSS FROM OPERATIONS
|
(6,544,564
|
)
|
(3,325,400
|
)
|
(23,136,292
|
)
|
(13,328,590
|
)
|
||||||||
OTHER INCOME:
|
||||||||||||||||
Interest Expense, net
|
(731,818
|
)
|
(663,463
|
)
|
(2,841,830
|
)
|
(846,831
|
)
|
||||||||
LOSS BEFORE INCOME TAXES
|
(7,276,382
|
)
|
(3,988,863
|
)
|
(25,978,122
|
)
|
(14,175,421
|
)
|
||||||||
Income tax benefit
|
137,198
|
99,953
|
456,794
|
500,292
|
||||||||||||
NET LOSS
|
$
|
(7,139,184
|
)
|
$
|
(3,888,910
|
)
|
$
|
(25,521,328
|
)
|
$
|
(13,675,129
|
)
|
||||
Basic and diluted loss per share
|
$
|
(0.35
|
)
|
$
|
(0.23
|
)
|
$
|
(1.34
|
)
|
$
|
(0.81
|
)
|
||||
Weighted average number of shares outstanding, basic and diluted
|
20,150,168
|
17,079,151
|
19,085,691
|
16,954,142
|
December 31, 2020
|
December 31, 2019
|
|||||||
- ASSETS -
|
||||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
$
|
23,066,301
|
$
|
18,271,352
|
||||
Accounts receivable, net of allowance for doubtful accounts of $254,232 and $62,000 as of December 31,
2020 and December 31, 2019, respectively
|
3,377,387
|
3,661,325
|
||||||
Inventories, net
|
12,516,402
|
9,598,030
|
||||||
Prepaid expenses and other current assets
|
778,683
|
693,013
|
||||||
TOTAL CURRENT ASSETS
|
39,738,773
|
32,223,720
|
||||||
FIXED ASSETS:
|
||||||||
Property, Plant and Equipment, net
|
8,688,403
|
5,933,569
|
||||||
Finance lease right-of-use asset, net
|
233,134
|
210,350
|
||||||
TOTAL FIXED ASSETS, net
|
8,921,537
|
6,143,919
|
||||||
OTHER ASSETS:
|
||||||||
Operating lease right-of-use assets, net
|
6,112,632
|
7,030,744
|
||||||
Intangible assets, net
|
3,645,986
|
3,914,352
|
||||||
Goodwill
|
5,963,744
|
5,872,690
|
||||||
Deposits and other assets
|
509,342
|
543,539
|
||||||
TOTAL ASSETS
|
$
|
64,892,014
|
$
|
55,728,964
|
||||
- LIABILITIES AND STOCKHOLDERS’ EQUITY -
|
||||||||
CURRENT LIABILITIES:
|
||||||||
Accounts payable and accrued liabilities
|
$
|
10,042,790
|
$
|
5,526,243
|
||||
Deferred revenue
|
1,606,997
|
125,000
|
||||||
Operating lease liabilities
|
642,460
|
41,894
|
||||||
Finance lease liabilities
|
58,877
|
568,294
|
||||||
Note payable
|
-
|
180,249
|
||||||
TOTAL CURRENT LIABILITIES
|
12,351,124
|
6,441,680
|
||||||
OTHER LIABILITIES:
|
||||||||
Long-term operating lease liabilities
|
6,327,143
|
6,969,603
|
||||||
Long-term finance lease liabilities
|
185,239
|
171,953
|
||||||
Long-term debt, less current portion, net
|
18,182,158
|
17,644,149
|
||||||
Deferred tax liability
|
69,941
|
466,326
|
||||||
TOTAL LIABILITIES
|
37,115,605
|
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; 20,223,498 shares and 17,733,617 shares
issued at December 31, 2020 and December 31, 2019, respectively
|
202,235
|
177,335
|
||||||
Additional paid-in capital
|
124,961,514
|
95,433,077
|
||||||
Accumulated deficit
|
(97,106,331
|
)
|
(71,585,003
|
)
|
||||
Treasury stock 41,141 and 0 shares at cost as of December 31, 2020 and December 31, 2019, respectively
|
(190,093
|
)
|
-
|
|||||
Accumulated other comprehensive (loss) income
|
(90,916
|
)
|
9,844
|
|||||
TOTAL STOCKHOLDERS’ EQUITY
|
27,776,409
|
24,035,253
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
64,892,014
|
$
|
55,728,964
|
December 31,
2020 |
December 31,
2019 |
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Cash received from customers and grants
|
$
|
34,736,133
|
$
|
37,930,172
|
||||
Cash paid to suppliers and employees
|
(50,238,409
|
)
|
(45,655,562
|
)
|
||||
Cash paid for operating leases
|
(1,139,944
|
)
|
(632,952
|
)
|
||||
Cash paid for finance leases
|
(19,987
|
)
|
(7,892
|
)
|
||||
Interest and taxes, net
|
(2,225,031
|
)
|
(689,272
|
)
|
||||
Net cash used in operating activities
|
(18,887,238
|
(9,055,506
|
)
|
|||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Purchase of businesses, net of cash acquired
|
-
|
(100,000
|
)
|
|||||
Acquisition of and deposits on fixed assets
|
(3,961,369
|
)
|
(3,502,540
|
)
|
||||
Patent Application Costs
|
(205,493
|
)
|
(297,006
|
)
|
||||
Working capital adjustment related to business combination
|
-
|
145,760
|
||||||
Net cash used in investing activities
|
(4,166,862
|
)
|
(3,753,786
|
)
|
||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds from sale of common stock, net
|
28,436,740
|
-
|
||||||
Proceeds from option exercises
|
-
|
32,486
|
||||||
Principal payments for finance leases
|
(51,166
|
)
|
(19,875
|
)
|
||||
Payments on debt issuance costs
|
-
|
(186,313
|
)
|
|||||
Payments on note payable
|
(180,249
|
)
|
(181,822
|
)
|
||||
Proceeds from issuance of long-term debt, net
|
-
|
18,850,000
|
||||||
Stimulus package loan
|
2,978,315
|
-
|
||||||
Payment of stimulus package loan
|
(2,978,315
|
)
|
-
|
|||||
Payments of tax withholdings on stock award
|
(441,723
|
)
|
-
|
|||||
Net cash provided by financing activities
|
27,763,602
|
18,494,476
|
||||||
Effect of exchange rate changes on cash
|
85,447
|
61,617
|
||||||
INCREASE IN CASH AND CASH EQUIVALENTS
|
4,794,949
|
5,746,801
|
||||||
Cash and cash equivalents - beginning of the period
|
18,271,352
|
12,524,551
|
||||||
Cash and cash equivalents - end of the period
|
$
|
23,066,301
|
$
|
18,271,352
|
||||
RECONCILIATION OF NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES:
|
||||||||
Net Loss
|
$
|
(25,521,328
|
)
|
$
|
(13,675,129
|
)
|
||
Adjustments:
|
||||||||
Depreciation and amortization
|
2,697,126
|
1,916,194
|
||||||
Share based compensation
|
1,223,171
|
1,655,900
|
||||||
Benefit from deferred tax liability
|
(396,385
|
)
|
(513,715
|
)
|
||||
Provision for doubtful accounts
|
270,193
|
20,000
|
||||||
Non-cash inventory changes
|
3,543,515
|
-
|
||||||
Changes in assets and liabilities, net of effects from acquisitions:
|
||||||||
Accounts receivable
|
283,939
|
3,764,045
|
||||||
Inventories
|
(6,461,887
|
)
|
(1,457,612
|
)
|
||||
Prepaid expenses and other current assets
|
(85,670
|
)
|
64,355
|
|||||
Deposits and other assets
|
34,195
|
(90,624
|
)
|
|||||
Accounts payable and accrued liabilities
|
4,043,896
|
(441,015
|
)
|
|||||
Deferred revenue
|
1,481,997
|
(297,905
|
)
|
|||||
Net cash used in operating activities
|
$
|
(18,887,238
|
)
|
$
|
(9,055,506
|
)
|
||
Supplemental disclosures for non-cash investing and financing activities:
|
||||||||
Deposits on manufacturing equipment transferred to fixed assets
|
$
|
472,651
|
$
|
430,000
|
||||
Issuance of common stock for net assets of business acquired
|
–
|
443,291
|
||||||
Contingent liability earnout
|
1,011,261
|
1,225,000
|