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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Chembio Diagnostics Inc | NASDAQ:CEMI | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.455 | 0.44 | 0.46 | 0 | 01:00:00 |
Nevada
|
88-0425691
|
|
(State or other jurisdiction of incorporation)
|
(IRS Employer Identification Number)
|
Large accelerated filer □
|
Accelerated filer
☒
|
|
Non-accelerated filer □ (Do not check if a smaller reporting company)
|
Smaller reporting company □
|
|
Emerging growth company □
|
|
|
Page
|
|
|
|
Part I. FINANCIAL INFORMATION:
|
||
|
Item 1. Financial Statements:
|
|
|
Condensed Consolidated Balance Sheets as of March 31, 2017 (unaudited) and December 31, 2016
|
2
|
|
||
|
Condensed Consolidated Statements of Operations (unaudited) for the three months ended March 31, 2017 and 2016
|
3
|
|
Condensed Consolidated Statements of Cash Flows (unaudited) for the three months ended March 31, 2017 and 2016
|
4
|
|
|
|
|
Notes to Condensed Consolidated Financial Statements (unaudited)
|
5
|
|
|
|
|
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
|
15
|
|
|
|
|
Item 4. Controls and Procedures
|
26
|
|
|
|
Part II. OTHER INFORMATION:
|
||
Item 6. Exhibits
|
27
|
|
|
||
SIGNATURES
|
28
|
|
|
||
EXHIBITS
|
For the three Months ended
|
||||||||
March 31, 2017
|
March 31, 2016
|
|||||||
REVENUES:
|
||||||||
Net product sales
|
$
|
5,427,427
|
$
|
5,917,019
|
||||
License and royalty revenue
|
100,000
|
22,201
|
||||||
R&D, milestone and grant revenue
|
797,740
|
661,879
|
||||||
TOTAL REVENUES
|
6,325,167
|
6,601,099
|
||||||
Cost of product sales
|
3,219,215
|
3,435,551
|
||||||
GROSS MARGIN
|
3,105,952
|
3,165,548
|
||||||
OPERATING EXPENSES:
|
||||||||
Research and development expenses
|
2,246,572
|
1,634,298
|
||||||
Selling, general and administrative expenses
|
2,488,337
|
1,999,404
|
||||||
4,734,909
|
3,633,702
|
|||||||
LOSS FROM OPERATIONS
|
(1,628,957
|
)
|
(468,154
|
)
|
||||
OTHER INCOME:
|
||||||||
Interest income
|
13,382
|
2,564
|
||||||
13,382
|
2,564
|
|||||||
LOSS BEFORE INCOME TAXES
|
(1,615,575
|
)
|
(465,590
|
)
|
||||
Income tax provision (benefit)
|
-
|
(162,000
|
)
|
|||||
NET LOSS
|
$
|
(1,615,575
|
)
|
$
|
(303,590
|
)
|
||
Basic loss per share
|
$
|
(0.13
|
)
|
$
|
(0.03
|
)
|
||
Diluted loss per share
|
$
|
(0.13
|
)
|
$
|
(0.03
|
)
|
||
Weighted average number of shares outstanding, basic
|
12,270,679
|
9,631,686
|
||||||
Weighted average number of shares outstanding, diluted
|
12,270,679
|
9,631,686
|
|
PRELIMINARY
|
|||
Property, plant and equipment
|
$
|
268,866
|
||
Goodwill
|
1,162,000
|
|||
Other intangible assets (estimated useful life):
|
||||
Intellectual property (approximate 10 year weighted average)
|
800,000
|
|||
Customer contracts / relationships (approximate 10 year weighted average)
|
700,000
|
|||
Order backlog (3 months)
|
200,134
|
|||
Trade names (approximate 11 year weighted average)
|
100,000
|
|||
Total consideration *
|
$
|
3,231,000
|
Proforma table
|
For the three months ended
March 31, 2016
|
|||
Total revenues
|
$
|
6,686,526
|
||
Net loss
|
$
|
501,288
|
||
Net loss per common share
|
$
|
.05
|
||
Diluted net loss per common share
|
$
|
.05
|
a) |
Basis of Presentation:
|
b) |
Revenue Recognition:
|
c) |
Inventories:
|
March 31, 2017
|
December 31, 2016
|
|||||||
Raw materials
|
$
|
1,849,280
|
$
|
1,824,248
|
||||
Work in process
|
448,130
|
535,320
|
||||||
Finished goods
|
1,457,071
|
975,620
|
||||||
$
|
3,754,481
|
$
|
3,335,188
|
d) |
Earnings Per Share:
|
For the three months ended
|
|||||
March 31, 2017
|
March 31, 2016
|
||||
Basic
|
12,270,679
|
9,631,686
|
|||
Diluted
|
12,270,679
|
9,631,686
|
e) |
Employee Stock Option Plan:
|
For the three months ended
|
|||
March 31, 2017
|
March 31, 2016
|
||
Expected term (in years)
|
5.0
|
5.0
|
|
Expected volatility
|
44.18%
|
48.66 %
|
|
Expected dividend yield
|
0%
|
0 %
|
|
Risk-free interest rate
|
1.58%
|
0.90 %
|
Stock Options
|
Number of Shares
|
Weighted Average Exercise Price per Share
|
Weighted Average Remaining Contractual Term
|
Aggregate Intrinsic Value
|
|||||||
Outstanding at December 31, 2016
|
600,549
|
$
|
4.55
|
3.43 years
|
$
|
1,463,052
|
|||||
Granted
|
86,000
|
5.72
|
|||||||||
Exercised
|
10,969
|
4.00
|
$
|
34,152
|
|||||||
Forfeited/expired/cancelled
|
785
|
5.56
|
|||||||||
Outstanding at March 31, 2017
|
674,795
|
$
|
4.70
|
3.52 years
|
$
|
700,450
|
|||||
Exercisable at March 31, 2017
|
355,795
|
$
|
4.21
|
3.01 years
|
$
|
432,430
|
f) |
Geographic Information:
|
For the three months ended
|
||||||||
March 31, 2017
|
March 31, 2016
|
|||||||
Africa
|
$
|
368,827
|
$
|
713,989
|
||||
Asia
|
1,420,422
|
64,005
|
||||||
Europe
|
440,725
|
123,096
|
||||||
North America
|
1,087,339
|
2,389,024
|
||||||
South America
|
2,110,114
|
2,626,905
|
||||||
$
|
5,427,427
|
$
|
5,917,019
|
g) |
Accounts Payable and Accrued Liabilities:
|
March 31, 2017
|
December 31, 2016
|
|||||||
Accounts payable – suppliers
|
$
|
1,439,170
|
$
|
1,437,290
|
||||
Accrued commissions
|
429,505
|
221,982
|
||||||
Accrued royalties / license fees
|
533,730
|
352,660
|
||||||
Accrued payroll
|
238,134
|
167,575
|
||||||
Accrued vacation
|
280,111
|
289,587
|
||||||
Accrued bonuses
|
-
|
282,500
|
||||||
Accrued expenses – other
|
477,507
|
261,539
|
||||||
TOTAL
|
$
|
3,398,157
|
$
|
3,013,133
|
h) |
Goodwill and Intangible Assets:
|
i) |
Recent Accounting Pronouncements Affecting the Company:
|
a) |
Brain Injury agreement:
|
b) |
Malaria agreement:
|
c) |
Fever Panel agreement:
|
d) |
BARDA Zika agreement:
|
e) |
USDA Bovid:
|
f) |
FIND agreement:
|
a) |
Economic Dependency:
|
For the three months ended
|
Accounts Receivable as of
|
|||||||||||||||||
March 31, 2017
|
March 31, 2016
|
March 31, 2017
|
March 31, 2016
|
|||||||||||||||
Sales
|
% of Sales
|
Sales
|
% of Sales
|
|||||||||||||||
Customer 1
|
$
|
1,939,587
|
36
|
%
|
$
|
2,589,405
|
44
|
%
|
$
|
2,781,266
|
$
|
2,694,495
|
||||||
Customer 2
|
*
|
*
|
1,796,477
|
30
|
%
|
*
|
860,420
|
|||||||||||
Customer 3
|
1,326,171
|
24
|
%
|
*
|
*
|
914,526
|
*
|
For the three months ended
|
Accounts Payable as of
|
||||||||||||||||
March 31, 2017
|
March 31, 2016
|
March 31, 2017
|
March 31, 2016
|
||||||||||||||
Purchases
|
% of Purc.
|
Purchases
|
% of Purc.
|
||||||||||||||
Vendor 1
|
$
|
-
|
0
|
%
|
$ |
222,902
|
14
|
%
|
$
|
*
|
$
|
-
|
|||||
Vendor 2
|
698,838
|
32
|
%
|
*
|
*
|
375,164
|
*
|
b) |
Governmental Regulation:
|
c) |
Employment Agreements:
|
●
|
DPP® HIV-Syphilis Assay
: The DPP® HIV-Syphilis Assay is a rapid, point-of-care (POC), multiplex test for the simultaneous detection of antibodies to HIV and to Treponema Pallidum (TP) bacteria (the causative agent of syphilis). This novel combination assay was developed to address the growing concern among public health officials regarding the rising co-infection rates of HIV and syphilis as well as mother-to-child transmission (MTCT) of HIV and syphilis. The product received approval by the Mexican regulatory agency (Cofepris) in 2014, received approval by the Brazilian regulatory agency, Agência Nacional de Vigilância Sanitária (ANVISA) in 2015, and received CE mark approval in 2017. We are developing a U.S. version of the DPP® HIV-Syphilis Assay, designed to meet the performance requirements for the "reverse" algorithm that is currently in clinical use for syphilis testing in the United States. The clinical trial to support the FDA application for the DPP® HIV-Syphilis Assay, which was initiated during first quarter of 2016, has been completed. In March 2017, the FDA requested further studies in addition to the clinical studies recently completed. As a result, Chembio is in discussion with the FDA regarding the timing of filing the Premarket Approval Application with the FDA.
|
●
|
DPP® Malaria Assay
: The DPP® Malaria Assay is a rapid, POC, multiplex test for the simultaneous detection of plasmodium falciparum, and other plasmodium infections. In January 2015, we received a grant from the Bill & Melinda Gates Foundation to expedite the development and feasibility testing of a POC DPP® Malaria Assay. The Company completed this project, which compared the new DPP
®
Malaria Assay to the world's leading currently-available POC malaria assay with favorable results: a ten-fold improvement in sensitivity. In April 2016, we received a second Malaria grant from the Bill & Melinda Gates Foundation to expedite the feasibility testing and development of the world's first oral fluid/saliva POC diagnostic test to simply and accurately identify individuals infected with all species of malaria. We recently completed the feasibility, and plan to deliver DPP
®
Malaria Assays to a partner of the Bill & Melinda Gates Foundation during the second quarter of 2017, to commence field evaluation.
|
●
|
DPP® Zika Assay
: The DPP® Zika Assay is a rapid POC stand-alone test for the simultaneous detection of IgM/IgG antibodies. In February 2016, we received a grant from The Paul G. Allen Family Foundation to initiate development the DPP® Zika Assay. During 2016, Chembio announced collaborations with Bio-Manguinhos, the unit of the Oswaldo Cruz Foundation (Fiocruz) responsible for the development and production of vaccines, diagnostics, and biopharmaceuticals, primarily to meet the demands of Brazil's national public health system, related to the DPP® Zika Assay. In August 2016, the Company received an award from the U.S. Government (HHS/ASPR/BARDA), granting the Company up to $13.2 million ($5.9 million to develop DPP® Zika Assay and obtain U.S. regulatory approval). The Company filed the following regulatory submissions: U.S. Food And Drug Administration Emergency Use Authorization (EUA), World Health Organization EUA, Brazil's regulatory agency ANVISA, Mexico's regulatory agency Cofepris, and CE mark. The Company obtained CE mark in July 2016, and then began selling in the Caribbean region via its distribution partner, Isla Lab, LLC. In September 2016, the Company received a contract award from CDC, to initiate a Zika surveillance program in India, Peru, Guatemala, and Haiti, and we began selling the DPP® Zika IgM/IgG Assay to CDC for field testing purposes during the first quarter of 2017. The Company received ANVISA approval (Brazil) for the DPP® Zika IgM/IgG Assay in November 2016, and is working with our Brazilian partner, Bio-Manguinhos, to obtain ANVISA approval for the DPP® Micro Reader.
|
●
|
DPP® Dengue Fever Assay
: The DPP® Dengue Fever Assay is a rapid, POC, multiplex test for the simultaneous detection of IgG/IgM and NS1 antigens. During 2016, Chembio announced collaborations with Bio-Manguinhos, the unit of the Oswaldo Cruz Foundation (Fiocruz) responsible for the development and production of vaccines, diagnostics, and biopharmaceuticals, primarily to meet the demands of Brazil's national public health system related to the DPP® Dengue Fever Assay. We completed verification and validation studies, and production of pilot lots, to support preclinical studies. Also during 2016, we initiated registration to begin initial commercialization in Southeast Asia, and we initiated sales of our DPP
®
Dengue Assay in Southeast Asia during Q1 2017.
|
●
|
DPP® Chikungunya Assay
: The DPP® Chikungunya Assay is a rapid, POC, multiplex test for the simultaneous detection of IgG/IgM antibodies. During 2016, Chembio announced collaborations with Bio-Manguinhos, the unit of the Oswaldo Cruz Foundation (Fiocruz) responsible for the development and production of vaccines, diagnostics, and biopharmaceuticals, primarily to meet the demands of Brazil's national public health system, related to the DPP® Chikungunya Assay.
|
●
|
DPP® Zika/Dengue/Chikungunya Assay
: The DPP® Zika/Dengue/Chikungunya Assay is a rapid, POC, multiplex test for the simultaneous detection of IgM/IgG antibodies. In February 2016, we received a grant from The Paul G. Allen Family Foundation to initiate development of the DPP® Zika/Dengue/Chikungunya Assay. During 2016, Chembio announced collaborations with Bio-Manguinhos, the unit of the Oswaldo Cruz Foundation (Fiocruz) responsible for the development and production of vaccines, diagnostics and biopharmaceuticals, primarily to meet the demands of Brazil's national public health system, related to the DPP® Zika/Dengue/Chikungunya Assay. In August 2016, the Company received an award from the U.S. Government (HHS/ASPR/BARDA), granting the Company up to $13.2 million (including an option of $7.3 million to develop DPP® Zika/Dengue/Chikungunya Assay and obtain U.S. regulatory approval). In September 2016, the Company received a contract award from CDC, to initiate a Zika, Dengue, and Chikungunya surveillance program in India, Peru, Guatemala, and Haiti, and we began selling the DPP® Zika/Dengue/Chikungunya IgM/IgG Assay to CDC during the first quarter of 2017.
|
●
|
DPP® Fever Panel Assay (1)
: The DPP® Fever Panel Assay is a rapid, POC, multiplex test for the simultaneous detection of Malaria, Dengue, Chikungunya, Zika, Ebola, Lassa, and Marburg. In October 2015, we received a $2.1 million grant from the Paul G. Allen Ebola Program to develop the DPP®
Fever Panel Assay and a $0.55 million follow-on grant to add a test for the detection of Zika virus. We completed the development of the DPP® Fever Panel Assay in 2016, including the addition of Zika, and we supplied 10,000 tests to FIND, which initiated field evaluation in Peru and Nigeria.
|
●
|
DPP® Fever Panel Assay (2)
: The DPP® Fever Panel Assay is a rapid, POC, multiplex test for the simultaneous detection of Malaria, Dengue, Chikungunya, Zika, leptospirosis,
Rickettsia typhi
,
Burkholderia pseudomallei
, and
Orientia tsutsugamushi
. In April 2017, the Company announced collaboration with FIND, to develop the DPP®
Asian Fever Panel Assay.
|
●
|
DPP® Ebola Assay and DPP®
Malaria-Ebola Assay
: The DPP® Ebola Assay is a rapid POC test for the detection of Ebola, and the DPP® Malaria-Ebola Assay is a rapid, POC, multiplex test for the simultaneous detection of Malaria and Ebola. In October 2014, we announced plans to develop, validate, and commercialize POC DPP
®
Assays for Ebola and Febrile Illness. We completed the development of the DPP® Ebola Assay and submitted it for Emergency Use Authorization (EUA) with the Food & Drug Administration (FDA) and World Health Organization (WHO), and we are actively engaged with these regulatory agencies. During the third and fourth quarters of 2015, we sold DPP® Ebola and DPP® Malaria-Ebola Assays to the Centers for Disease Control & Prevention (CDC) for field studies in West Africa, which is ongoing.
|
●
|
DPP® Cancer Assay
: The DPP® Cancer Assay is a rapid, POC, multiplex test for the early detection and monitoring of a specific type of cancer. In October 2014, we entered into collaboration with an international diagnostics company to develop a POC diagnostic test for a specific type of cancer. This program is fully funded by this partner. However, under the terms of the agreement, neither Chembio's partner nor the specific type of cancer is being disclosed. The cancer project represents an application of the DPP® technology outside of the infectious disease field, and the scope of the agreement involves product development of a quantitative, reader-based cancer assay for two cancer markers, utilizing Chembio's DPP® technology and DPP® Micro Reader. During the third quarter of 2015, we completed successful feasibility, and our partner agreed to fund continued development of the DPP® Cancer Assay, which development and verification is ongoing.
|
●
|
DPP® Traumatic Brain Injury Assay:
The DPP® Traumatic Brain Injury Assay is a rapid POC test for the detection of traumatic brain injury (TBI) and sports-related concussion. In January 2015, we entered into an agreement with the Concussion Science Group (CSG) Division of Perseus Science Group LLC, to combine CSG's patented biomarker with our proprietary DPP® platform and DPP® Micro Reader, to develop a semi-quantitative or quantitative POC test, to diagnose TBI. The DPP® Traumatic Brain Injury Assay is in the feasibility and pre-clinical stage. Under institutional review board (IRB) agreements with multiple hospitals, we are conducting pre-clinical studies of the prototype DPP® Traumatic Brain Injury Assay using patient samples.
|
●
|
DPP® Bovine Tuberculosis
:
The DPP
®
BovidTB Assay is a rapid POC test for the detection of bovine tuberculosis (TB). In September 2016, the Company was awarded a $600,000 grant from the United States Department of Agriculture (USDA) to develop the DPP
®
BovidTB Assay. The grant will be managed by the Small Business Innovation Research Program (SBIR) of the National Institute of Food and Agriculture (NIFA), a federal agency within the USDA, and the assay will be developed in collaboration with National Animal Disease Center (NADC) and Infectious Disease Research Institute (IDRI). Under the two-year grant, Chembio will use its patented DPP
®
technology to undertake to develop a simple, rapid, accurate and cost-effective test for bovine TB in cattle. The DPP
®
BovidTB Assay will be designed to provide results within 20 minutes, thereby significantly improving on the time-consuming, tedious and inadequate diagnostic methods currently in use.
|
●
|
DPP® HIV-Syphilis Assay:
We have developed a U.S. version of the DPP® HIV-Syphilis Assay, designed to meet the performance requirements for the "reverse" algorithm that is currently in clinical use for syphilis testing in the United States. The clinical trial to support the FDA application for the DPP® HIV-Syphilis Assay, which was initiated during first quarter of 2016, has been completed. In March 2017, the FDA requested further studies in addition to the clinical studies recently completed. As a result Chembio is in discussion with the FDA regarding the timing of filing the Premarket Approval Application with the FDA.
|
●
|
DPP® Zika IgM/IgG System
: In July of 2016 Chembio obtained a CE Mark for the DPP® Zika IgM/IgG Assay. The DPP® Zika IgM/IgG System, which includes an assay utilizing the patented DPP® technology as well as a digital reader (DPP® Micro Reader), is now cleared for commercialization in European countries as well as the majority of the Caribbean nations, not including U.S. territories. In November of 2016, we received approval from ANVISA, Brazil's regulatory Agency, and we are working with our Brazilian partner, Bio-Manguinhos, to obtain ANVISA approval for the DPP® Micro Reader. We have also filed regulatory submissions to FDA (Emergency Use Authorization), the World Health Organization (Emergency Use Assessment and Listing), and Cofepris (Mexico), and we are actively engaged with these organizations.
|
Selected Product Categories:
|
For the three Months ended
|
|||||||||||||||
March 31, 2017
|
March 31, 2016
|
$ Change
|
% Change
|
|||||||||||||
Lateral Flow HIV Tests and Components
|
$
|
1,632,014
|
$
|
3,056,531
|
$
|
(1,424,517
|
)
|
-46.61
|
%
|
|||||||
DPP® Tests and Components
|
2,218,618
|
2,657,884
|
(439,266
|
)
|
-16.53
|
%
|
||||||||||
Other
|
1,576,795
|
202,604
|
1,374,191
|
678.26
|
%
|
|||||||||||
Net Product Sales
|
5,427,427
|
5,917,019
|
(489,592
|
)
|
-8.27
|
%
|
||||||||||
License and royalty revenue
|
100,000
|
22,201
|
77,799
|
350.43
|
%
|
|||||||||||
R&D, milestone and grant revenue
|
797,740
|
661,879
|
135,861
|
20.53
|
%
|
|||||||||||
Total Revenues
|
$
|
6,325,167
|
$
|
6,601,099
|
$
|
(275,932
|
)
|
-4.18
|
%
|
For the three Months ended
|
For the three Months ended | |||||||||||||||||||||
Region
|
March 31, 2017
|
March 31, 2016
|
$ Change
|
Part-Type
|
March 31, 2017
|
March 31, 2016
|
$ Change
|
|||||||||||||||
Africa
|
$ |
368,827
|
$ |
713,989
|
$ |
(345,162
|
)
|
DPP
|
$ |
88,380
|
$ |
10
|
$ |
88,370
|
||||||||
LF-HIV
|
276,276
|
713,979
|
(437,703
|
)
|
||||||||||||||||||
OTHER
|
4,171
|
0
|
4,171
|
|||||||||||||||||||
Asia
|
1,420,422
|
60,378
|
1,360,044
|
DPP
|
5,000
|
0
|
5,000
|
|||||||||||||||
LF-HIV
|
16,399
|
60,168
|
(43,769
|
)
|
||||||||||||||||||
OTHER
|
1,399,023
|
210
|
1,398,813
|
|||||||||||||||||||
Europe
|
440,725
|
123,096
|
317,629
|
DPP
|
500
|
250
|
250
|
|||||||||||||||
LF-HIV
|
438,799
|
113,642
|
325,157
|
|||||||||||||||||||
OTHER
|
1,426
|
9,204
|
(7,778
|
)
|
||||||||||||||||||
Latin America
|
2,110,114
|
2,678,905
|
(568,791
|
)
|
DPP
|
1,943,567
|
2,589,405
|
(645,838
|
)
|
|||||||||||||
LF-HIV
|
39,685
|
60,000
|
(20,315
|
)
|
||||||||||||||||||
OTHER
|
126,862
|
29,500
|
97,362
|
|||||||||||||||||||
Other
|
0
|
3,627
|
(3,627
|
)
|
DPP
|
0
|
0
|
0
|
||||||||||||||
LF-HIV
|
0
|
3,625
|
(3,625
|
)
|
||||||||||||||||||
OTHER
|
0
|
2
|
(2
|
)
|
||||||||||||||||||
USA
|
1,087,339
|
2,337,024
|
(1,249,685
|
)
|
DPP
|
181,171
|
68,219
|
112,952
|
||||||||||||||
LF-HIV
|
860,910
|
2,100,701
|
(1,239,791
|
)
|
||||||||||||||||||
OTHER
|
45,258
|
168,104
|
(122,846
|
)
|
||||||||||||||||||
TOTALS
|
$ |
5,427,427
|
$ |
5,917,019
|
$ |
(489,592
|
)
|
-
|
$ |
5,427,427
|
$ |
5,917,019
|
$ |
(489,592
|
)
|
For the three Months ended
|
||||||||||||||||
March 31, 2017
|
March 31, 2016
|
$ Change
|
% Change
|
|||||||||||||
Gross Margin per Statement of Operations
|
$
|
3,105,952
|
$
|
3,165,548
|
$
|
(59,596
|
)
|
-1.88
|
%
|
|||||||
Less: R&D, milestone, grant, license and royalty revenues
|
897,740
|
684,080
|
213,660
|
31.23
|
%
|
|||||||||||
Gross Margin from Net Product Sales
|
$
|
2,208,212
|
$
|
2,481,468
|
$
|
(273,256
|
)
|
-11.01
|
%
|
|||||||
Product Gross Margin %
|
40.69
|
%
|
41.94
|
%
|
Selected expense lines:
|
For the three Months ended
|
|||||||||||||||
March 31, 2017
|
March 31, 2016
|
$ Change
|
% Change
|
|||||||||||||
Clinical and Regulatory Affairs:
|
||||||||||||||||
Wages and related costs
|
$
|
132,113
|
$
|
132,569
|
$
|
(456
|
)
|
-0.34
|
%
|
|||||||
Consulting
|
-
|
4,396
|
(4,396
|
)
|
-100.00
|
%
|
||||||||||
Stock-based compensation
|
9,652
|
-
|
9,652
|
100.00
|
%
|
|||||||||||
Clinical trials
|
472,945
|
52,095
|
420,850
|
807.85
|
%
|
|||||||||||
Other
|
10,658
|
13,700
|
(3,042
|
)
|
-22.20
|
%
|
||||||||||
Total Regulatory
|
625,368
|
202,760
|
422,608
|
208.43
|
%
|
|||||||||||
R&D Other than Regulatory:
|
||||||||||||||||
Wages and related costs
|
726,322
|
740,031
|
(13,709
|
)
|
-1.85
|
%
|
||||||||||
Consulting
|
49,009
|
5,660
|
43,349
|
765.88
|
%
|
|||||||||||
Stock-based compensation
|
43,457
|
7,457
|
36,000
|
482.77
|
%
|
|||||||||||
Materials and supplies
|
674,057
|
560,232
|
113,825
|
20.32
|
%
|
|||||||||||
Other
|
128,359
|
118,158
|
10,201
|
8.63
|
%
|
|||||||||||
Total other than Regulatory
|
1,621,204
|
1,431,538
|
189,666
|
13.25
|
%
|
|||||||||||
Total Research and Development
|
$
|
2,246,572
|
$
|
1,634,298
|
$
|
612,274
|
37.46
|
%
|
Selected expense lines:
|
For the three Months ended
|
|||||||||||||||
March 31, 2017
|
March 31, 2016
|
$ Change
|
% Change
|
|||||||||||||
Wages and related costs
|
$
|
1,032,194
|
$
|
814,249
|
$
|
217,945
|
26.77
|
%
|
||||||||
Consulting
|
9,425
|
61,744
|
(52,319
|
)
|
-84.74
|
%
|
||||||||||
Commissions
|
231,724
|
315,980
|
(84,256
|
)
|
-26.66
|
%
|
||||||||||
Stock-based compensation
|
74,297
|
46,132
|
28,165
|
61.05
|
%
|
|||||||||||
Marketing materials
|
110,976
|
50,133
|
60,843
|
121.36
|
%
|
|||||||||||
Investor relations/investment bankers
|
69,622
|
82,926
|
(13,304
|
)
|
-16.04
|
%
|
||||||||||
Legal, accounting and compliance
|
301,381
|
332,117
|
(30,736
|
)
|
-9.25
|
%
|
||||||||||
Travel, entertainment and trade shows
|
170,307
|
90,484
|
79,823
|
88.22
|
%
|
|||||||||||
Other
|
488,411
|
205,639
|
282,772
|
137.51
|
%
|
|||||||||||
Total S, G &A
|
$
|
2,488,337
|
$
|
1,999,404
|
$
|
488,933
|
24.45
|
%
|
For the three Months ended
|
||||||||||||||||
March 31, 2017
|
March 31, 2016
|
$ Change
|
% Change
|
|||||||||||||
Interest income
|
$
|
13,382
|
$
|
2,564
|
$
|
10,818
|
421.92
|
%
|
||||||||
Total Other Income
|
$
|
13,382
|
$
|
2,564
|
$
|
10,818
|
421.92
|
%
|
Selected Changes in Financial Condition
|
As of
|
|||||||||||||||
March 31, 2017
|
December 31, 2016
|
$ Change
|
% Change
|
|||||||||||||
Cash and cash equivalents
|
$
|
5,582,482
|
$
|
10,554,464
|
$
|
(4,971,982
|
)
|
-47.11
|
%
|
|||||||
Accounts receivable, net of allowance for doubtful accounts of $52,000 at March 31, 2017 and December 31, 2016, respectively
|
5,681,524
|
3,383,729
|
2,297,795
|
67.91
|
%
|
|||||||||||
Inventories
|
3,754,481
|
3,335,188
|
419,293
|
12.57
|
%
|
|||||||||||
Fixed assets, net of accumulated depreciation
|
1,901,557
|
1,709,321
|
192,236
|
11.25
|
%
|
|||||||||||
Deposits on manufacturing equipment
|
173,499
|
31,900
|
141,599
|
443.88
|
%
|
|||||||||||
Deposits and other assets
|
161,189
|
720,489
|
(559,300
|
)
|
-77.63
|
%
|
||||||||||
Prepaid expenses and other current assets
|
910,413
|
840,145
|
70,268
|
8.36
|
%
|
|||||||||||
Goodwill
|
1,162,000
|
-
|
1,162,000
|
100.00
|
%
|
|||||||||||
Intangible assets, net
|
1,560,361
|
-
|
1,560,361
|
100.00
|
%
|
|||||||||||
Accounts payable and accrued liabilities
|
3,398,157
|
3,013,133
|
385,024
|
12.78
|
%
|
|||||||||||
Deferred revenue
|
116,668
|
392,517
|
(275,849
|
)
|
-70.28
|
%
|
For the three Months ended
|
||||||||||||||||
March 31, 2017
|
March 31, 2016
|
$ Change
|
% Change
|
|||||||||||||
|
||||||||||||||||
Net cash used in operating activities
|
$
|
(3,871,811
|
)
|
$
|
(2,690,610
|
)
|
$
|
(1,181,201
|
)
|
43.90
|
%
|
|||||
Net cash used in investing activities
|
(1,100,171
|
)
|
(28,407
|
)
|
(1,071,764
|
)
|
3,772.89
|
%
|
||||||||
Net cash provided by financing activities
|
-
|
-
|
-
|
N/A
|
||||||||||||
DECREASE IN CASH AND CASH EQUIVALENTS
|
$
|
(4,971,982
|
)
|
$
|
(2,719,017
|
)
|
$
|
(2,252,965
|
)
|
82.86
|
%
|
ITEM 4. |
CONTROLS AND PROCEDURES
|
(a) |
Disclosure Controls and Procedures
. Under the supervision and with the participation of our senior management, consisting of our principal executive officer and our principal financial officer, we conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), as of the end of the period covered by this report. Based on this evaluation, our management, including our principal executive officer and principal financial officer, concluded that as of March 31, 2017 our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms. Our disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in our Exchange Act reports is accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate to allow timely decisions regarding required disclosure.
|
(b) |
Changes in Internal Control over Financial Reporting
. There were no changes in our internal control over financial reporting identified in connection with the evaluation required by paragraph (d) of Rule 13a-15 or Rule 15d-15 under the Exchange Act that occurred during the three months ended March 31, 2017 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
|
Number
|
|
Description
|
3.1
|
|
|
3.2
|
|
Bylaws and Bylaw Amendments. (2)
|
3.3
|
|
|
4.1
|
|
|
4.2
|
|
|
4.3
|
|
|
4.4
|
|
|
4.5
|
|
|
4.6
|
|
Form of Warrant (to be filed by amendment)
|
10.1*
|
|
|
10.2*
|
|
|
10.3*
|
|
|
10.4*
|
||
10.5*
|
||
10.6
|
|
|
10.8
|
|
|
10.9
|
|
|
10.10
|
|
|
10.11
|
|
|
10.12
|
||
14.1
|
|
Ethics Policy
(12)
|
31.1
|
|
Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
31.2
|
|
Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
32
|
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
101.INS
|
|
XBRL Instance Document
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF
|
|
XBRL Taxonomy Definition Linkbase Document
|
101.LAB
|
|
XBRL Taxonomy Label Linkbase Document
|
101.PRE
|
|
XBRL Taxonomy Presentation Linkbase Document
|
1
|
|
Incorporated by reference to the Registrant's Quarterly Report on Form 10-Q filed with the Commission on July 29, 2010.
|
2
|
|
Incorporated by reference to the Registrant's registration statement on
Form SB-2 (File No. 333-85787) filed with the Commission on August 23, 1999
and the Registrant's Forms 8-K filed on
May 14, 2004
,
December 20, 2007
and
April 18, 2008
.
|
3
|
|
Incorporated by reference to the Registrant's definitive proxy statement on Schedule 14A filed with the Commission on August 3, 2012.
|
4
|
|
Incorporated by reference to the Registrant's Quarterly Report on Form 10-Q filed with the Commission on May 8, 2014.
|
5
|
|
Incorporated by reference to the Registrant's definitive proxy statement on Schedule 14A filed with the Commission on April 29, 2014.
|
6
|
|
Incorporated by reference to the Registrant's Quarterly Report on Form 10-Q filed with the Commission on August 7, 2014.
|
7
|
|
Incorporated by reference to the Registrant's registration statement on Form 8-A filed with the Commission on April 7, 2016.
|
8
|
|
Incorporated by reference to the Registrant's Current Report on Form 8-K filed with the Commission on March 14, 2016.
|
9
|
|
Incorporated by reference to the Registrant's Current Report on Form 8-K filed with the Commission on June 17, 2015.
|
10
|
|
Incorporated by reference to the Registrant's Current Report on Form 8-K filed with the Commission on October 5, 2006.
|
11
|
|
Incorporated by reference to the Registrant's Annual Report on Form 10-K filed with the Commission on March 5, 2015.
|
12
|
|
Incorporated by reference to the Registrant's Annual Report on Form 10-KSB filed with the Commission on March 30, 2006.
|
13
|
|
Incorporated by reference to the Registrant's Current Report on Form 8-K filed with the Commission on April 7, 2016.
|
14
|
Incorporated by reference to the Registrant's Current Report on Form 8-K filed with the Commission on January 10, 2017.
|
|
|
|
|
(*)
|
|
An asterisk (*) beside an exhibit number indicates the exhibit contains a management contract, compensatory plan or arrangement which is required to be identified in this report.
|
|
||
Chembio Diagnostics, Inc. | ||
Date:
|
May 9, 2017
|
By:
/s/ John J. Sperzel III
|
|
|
John J. Sperzel III
|
|
|
Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
Date:
|
May 9, 2017
|
By:
/s / Richard J. Larkin
|
|
|
Richard J. Larkin
|
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer)
|
1 Year Chembio Diagnostics Chart |
1 Month Chembio Diagnostics Chart |
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