0001092662-17-000075.txt : 20170809 0001092662-17-000075.hdr.sgml : 20170809 20170809160744 ACCESSION NUMBER: 0001092662-17-000075 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 39 CONFORMED PERIOD OF REPORT: 20170630 FILED AS OF DATE: 20170809 DATE AS OF CHANGE: 20170809 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CHEMBIO DIAGNOSTICS, INC. CENTRAL INDEX KEY: 0001092662 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 880425691 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-35569 FILM NUMBER: 171017916 BUSINESS ADDRESS: STREET 1: 3661 HORSEBLOCK ROAD CITY: MEDFORD STATE: NY ZIP: 11763 BUSINESS PHONE: (631) 924-1135 MAIL ADDRESS: STREET 1: 3661 HORSEBLOCK ROAD CITY: MEDFORD STATE: NY ZIP: 11763 FORMER COMPANY: FORMER CONFORMED NAME: Chembio Diagnostics Inc. DATE OF NAME CHANGE: 20040607 FORMER COMPANY: FORMER CONFORMED NAME: TRADING SOLUTIONS COM INC DATE OF NAME CHANGE: 19990805 10-Q 1 form10q.htm FORM 10-Q SECOND QUARTER 2017  
  
 
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
_______________________________
 
FORM 10 - Q
 
_______________________________
 
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
 
For the quarterly period ended June 30, 2017
 
OR
□ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from: ______ to ________

000-30379
(Commission File Number)

Chembio Diagnostics, Inc.
(Exact name of registrant as specified in its charter)

Nevada
  
88-0425691
(State or other jurisdiction of incorporation)
  
(IRS Employer Identification Number)

3661 Horseblock Road
Medford, New York 11763
(Address of principal executive offices including zip code)
(631) 924-1135
(Registrant's telephone number, including area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ☒ No □

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).   Yes ☒  No □

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer", "accelerated filer", "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one):

 
Large accelerated filer □
Accelerated filer ☒
 
Non-accelerated filer □  (Do not check if a smaller reporting company)
Smaller reporting company □
 
   Emerging growth company □

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Yes □ No □

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes □ No ☒

As of August 4, 2017, the Registrant had 12,309,122 shares outstanding of its $.01 par value common stock.

Quarterly Report on FORM 10-Q
For The Quarterly Period Ended
June 30, 2017

Table of Contents

Chembio Diagnostics, Inc.

 
 
Page
 
 
  
Part I. FINANCIAL INFORMATION:
  
 
Item 1. Financial Statements:
  
 
Condensed Consolidated Balance Sheets as of June 30, 2017 (unaudited) and December 31, 2016
2
 
    
 
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) for the for the three and six months ended June 30, 2017 and 2016
3
     
 
Condensed Consolidated Statements of Cash Flows (unaudited) for the six months ended June 30, 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
16
 
    
 
Item 4. Controls and Procedures
31
 
    
Part II. OTHER INFORMATION:
  
     
 
Item 6. Exhibits
32
 
    
SIGNATURES
33
 
    
EXHIBITS 
  



PART I
Item 1. FINANCIAL STATEMENTS
CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
AS OF

   
June 30, 2017
    
December 31, 2016
  
   
(Unaudited)
        
- ASSETS -
            
CURRENT ASSETS:
            
Cash and cash equivalents
  
$
3,691,783
    
$
10,554,464
  
Accounts receivable, net of allowance for doubtful accounts of $52,000 at June 30, 2017 and December 31, 2016, respectively
    
4,671,627
      
3,383,729
  
Inventories, net
    
4,993,951
      
3,335,188
  
Prepaid expenses and other current assets
    
777,688
      
840,145
  
TOTAL CURRENT ASSETS
    
14,135,049
      
18,113,526
  
                 
FIXED ASSETS, net of accumulated depreciation
    
2,093,494
      
1,709,321
  
                 
OTHER ASSETS:
                
Goodwill
    
1,571,104
      
-
  
Intangible assets, net
    
1,588,968
      
-
  
Deposits on manufacturing equipment
    
51,573
      
31,900
  
Deposits and other assets
    
156,088
      
720,489
  
TOTAL ASSETS
  
$
19,596,276
    
$
20,575,236
  
                 
- LIABILITIES AND STOCKHOLDERS' EQUITY -
                
CURRENT LIABILITIES:
                
Accounts payable and accrued liabilities
  
$
3,701,436
    
$
3,013,133
  
Deferred revenue
    
161,356
      
392,517
  
TOTAL CURRENT LIABILITIES
    
3,862,792
      
3,405,650
  
                 
OTHER LIABILITIES:
                
Deferred tax liability
    
335,990
      
-
  
TOTAL LIABILITIES
    
4,198,782
      
3,405,650
  
                 
COMMITMENTS AND CONTINGENCIES
                
                 
STOCKHOLDERS' EQUITY:
                
Preferred stock - 10,000,000 shares authorized; none outstanding
    
-
      
-
  
Common stock - $.01 par value; 100,000,000 shares authorized; 12,299,122 and 12,026,847 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively
    
122,991
      
120,268
  
Additional paid-in capital
    
62,611,394
      
60,721,783
  
Accumulated other comprehensive income
    
124,241
      
-
  
Accumulated deficit
    
(47,461,132
)
    
(43,672,465
)
TOTAL STOCKHOLDERS' EQUITY
    
15,397,494
      
17,169,586
  
                 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
  
$
19,596,276
    
$
20,575,236
  

See accompanying notes to condensed consolidated financial statements

2

CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)

   
For the three months ended
    
For the six months ended
  
   
June 30, 2017
    
June 30, 2016
    
June 30, 2017
    
June 30, 2016
  
REVENUES:
                        
Net product sales
  
$
2,892,942
    
$
2,034,072
    
$
8,320,314
    
$
7,951,091
  
License and royalty revenue
    
227,635
      
33,895
      
327,689
      
56,096
  
R&D, milestone and grant revenue
    
994,237
      
1,198,438
      
1,791,977
      
1,860,317
  
TOTAL REVENUES
    
4,114,814
      
3,266,405
      
10,439,980
      
9,867,504
  
                                 
Cost of product sales
    
2,203,843
      
1,686,100
      
5,423,057
      
5,121,651
  
                                 
GROSS MARGIN
    
1,910,971
      
1,580,305
      
5,016,923
      
4,745,853
  
                                 
OPERATING EXPENSES:
                                
Research and development expenses
    
1,982,426
      
2,367,466
      
4,228,998
      
4,001,764
  
Selling, general and administrative expenses
    
2,109,360
      
1,598,813
      
4,597,696
      
3,598,217
  
     
4,091,786
      
3,966,279
      
8,826,694
      
7,599,981
  
LOSS FROM OPERATIONS
    
(2,180,815
)
    
(2,385,974
)
    
(3,809,771
)
    
(2,854,128
)
                                 
OTHER INCOME:
                                
Interest income
    
7,722
      
1,310
      
21,104
      
3,874
  
     
7,722
      
1,310
      
21,104
      
3,874
  
                                 
LOSS BEFORE INCOME TAXES
    
(2,173,093
)
    
(2,384,664
)
    
(3,788,667
)
    
(2,850,254
)
                                 
Income tax provision
    
-
      
5,962,818
      
-
      
5,800,818
  
                                 
NET LOSS
  
$
(2,173,093
)
  
$
(8,347,482
)
  
$
(3,788,667
)
  
$
(8,651,072
)
                                 
Foreign currency translation adjustments
    
124,241
      
-
      
124,241
      
-
  
                                 
Comprehensive loss
  
$
(2,048,852
)
  
$
(8,347,482
)
  
$
(3,664,426
)
  
$
(8,651,072
)
                                 
                                 
Basic loss per share
  
$
(0.18
)
  
$
(0.86
)
  
$
(0.31
)
  
$
(0.90
)
                                 
Diluted loss per share
  
$
(0.18
)
  
$
(0.86
)
  
$
(0.31
)
  
$
(0.90
)
                                 
Weighted average number of shares outstanding, basic
    
12,299,122
      
9,667,543
      
12,284,979
      
9,649,612
  
                                 
Weighted average number of shares outstanding, diluted
    
12,299,122
      
9,667,543
      
12,284,979
      
9,649,612
  
                                 

See accompanying notes to condensed consolidated financial statements

3
CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE SIX MONTHS ENDED
(Unaudited)

   
June 30, 2017
    
June 30, 2016
  
             
CASH FLOWS FROM OPERATING ACTIVITIES:
            
Cash received from customers and grants
  
$
8,920,921
    
$
8,176,364
  
Cash paid to suppliers and employees
    
(14,398,812
)
    
(12,036,793
)
Interest received
    
21,104
      
3,874
  
Net cash used in operating activities
    
(5,456,787
)
    
(3,856,555
)
                 
CASH FLOWS FROM INVESTING ACTIVITIES:
                
Payment for net assets of business acquired
    
(850,000
)
    
-
  
Acquisition of and deposits on fixed assets
    
(555,894
)
    
(85,877
)
Net cash used in investing activities
    
(1,405,894
)
    
(85,877
)
                 
CASH FLOWS FROM FINANCING ACTIVITIES:
                
Net cash provided by financing activities
    
-
      
5,370
  
                 
DECREASE IN CASH AND CASH EQUIVALENTS
    
(6,862,681
)
    
(3,937,062
)
Cash and cash equivalents - beginning of the period
    
10,554,464
      
5,376,931
  
                 
Cash and cash equivalents - end of the period
  
$
3,691,783
    
$
1,439,869
  
                 
RECONCILIATION OF NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES:
                
                 
Net Loss
  
$
(3,788,667
)
  
$
(8,651,072
)
Adjustments:
                
Depreciation and amortization
    
773,566
      
580,159
  
Deferred taxes
    
-
      
5,800,818
  
Share based compensation
    
209,609
      
146,265
  
Changes in assets and liabilities:
                
Accounts receivable
    
(1,287,898
)
    
(2,156,582
)
Inventories
    
(1,658,763
)
    
96,206
  
Prepaid expenses and other current assets
    
(25,043
)
    
(46,226
)
Deposits and other assets
    
8,729
      
1,505
  
Accounts payable and accrued liabilities
    
542,841
      
(93,070
)
Customer deposits and deferred revenue
    
(231,161
)
    
465,442
  
Net cash used in operating activities
  
$
(5,456,787
)
  
$
(3,856,555
)
                 
Supplemental disclosures for non-cash investing and financing activities:
                
Deposits on manufacturing equipment transferred to fixed assets
  
$
174,399
    
$
43,590
  
Accrual of contingent earn-out
    
148,000
      
-
  
Issuance of common stock for net assets of business acquired
    
1,682,725
      
-
  


See accompanying notes to condensed consolidated financial statements

4
CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
NOTE 1 — DESCRIPTION OF BUSINESS:

Chembio Diagnostics, Inc. (the "Company" or "Chembio") and its wholly-owned subsidiaries, Chembio Diagnostic Systems Inc., and RVR Diagnostics Sdn Bhd ("RVR"), develop, manufacture, and market rapid diagnostic tests that detect infectious diseases. The Company's main lateral flow products are three rapid tests for the detection of HIV antibodies in whole blood, serum and plasma samples, two of which were approved by the FDA in 2006; the third is sold for export only. In addition, the Company has several products based on its patented Dual Path Platform (DPP®) technology, including a HIV test approved by the FDA in 2013 and CLIA-Waived in 2014. Lateral Flow Rapid HIV tests represented 39% of the Company's product revenues in the first six months of 2017. The Company's products based on its DPP® platform represented approximately 41% of the Company's product revenues in the first six months of 2017. The Company also has other rapid tests and components that together represented approximately 20% of product sales in the first six months of 2017. The Company's products are sold to medical laboratories and hospitals, governmental and public health entities, non-governmental organizations, medical professionals and retail establishments, both domestically and internationally. Chembio's products are sold under the Company's STAT PAK®, SURE CHECK®, STAT-VIEW® or DPP® registered trademarks, or under the private labels of its marketing partners. All of the Company's products that are currently being developed are based on its patented DPP®, which is a unique diagnostic point-of-care platform that has certain advantages over lateral flow technology.

NOTE 2 — ACQUISITION OF RVR DIAGNOSTICS SDN BHD:

On January 9, 2017, pursuant to a stock purchase agreement (the "Stock Purchase Agreement), the Company acquired all of the outstanding common stock of RVR Diagnostics Sdn Bhd, a Malaysia corporation ("RVR"), for $3,231,000, utilizing some of the proceeds from the funds raised by the Company in August 2016, the issuance of Chembio's common stock, and a contingent consideration, as described below, related to RVR reaching a milestone based on revenues that was valued at $148,000.  RVR is a privately-held Malaysia based manufacturing company focused on assembly and sales of rapid medical assays.  The Company acquired RVR to have a better presence in Asia, access to lower cost, shorter approval time of in-country regulatory approvals, and a lower cost assembly operation.

Pursuant to the Stock Purchase Agreement, the Company acquired all of the issued and outstanding common stock and other equity interests of RVR for (i) a cash payment of $1,400,000, of which $550,000 was paid as a deposit in December 2016 and (ii) 269,236 shares of Chembio's common stock, with a value at closing of $1,683,000, of which 7,277 shares are being held back to satisfy certain potential claims under the Stock Purchase Agreement and will become issuable to the sellers, if at all, on the one-year anniversary of the closing.

In addition, the Stock Purchase Agreement provides that the sellers may become entitled to receive certain milestone payments based on the achievement of performance goals related to sales by RVR during the 12 months ending December 31, 2017. RVR's actual sales during that period will be used to determine the "Milestone Proration Amount," which is a fraction that (i) the numerator of which is the positive amount, if any, by which actual sales for calendar year 2017 are greater than $2,250,000, up to a maximum overage of $250,000, and (ii) the denominator of which is $250,000. Based on the actual sales achieved by RVR, the Sellers will be entitled to receive (i) a cash milestone payment equal to $100,000 multiplied by the Milestone Proration Amount, for a maximum cash milestone payment of $100,000, and (ii) a stock milestone payment equal to 21,830 shares of Chembio common stock multiplied by the Milestone Proration Amount, with a maximum stock milestone payment of 21,830 shares of Chembio common stock.  As of March 31, 2017 the Company accrued $148,000 for the milestone.  This amount is the estimated value of the common stock of $85,000 based on the assumption of reaching the milestone of 74.5% and discounted by 15%, as well as the cash portion of the milestone payment valued at $63,000.  There was no change in the fair value of this contingent milestone payment through June 30, 2017.

As a result of the consideration paid exceeding the preliminary fair value of the net assets acquired, goodwill in the amount of $1,503,361 was recorded in connection with this acquisition, none of which will be deductible for tax purposes. In addition, the Company recorded $1,800,000 in intangible assets, which results largely from the addition of RVR's intellectual property, customer base and distribution channels, trade names, order backlog, industry reputation, and management talent and workforce. Our Condensed Consolidated Statements of Operations for the six months ended June 30, 2017 include $25,000 of transaction costs related to the RVR acquisition, which are reflected as general and administrative expenses.
 
5
CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
The acquisition was accounted for using the purchase method of accounting.  The following table summarizes the preliminary allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed on the closing date of January 9, 2017:

 
  
PRELIMINARY
  
       
Property, plant and equipment
  
$
235,141
  
Goodwill
    
1,503,361
  
Deferred tax liability
    
(307,636
)
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
  

* Total consideration includes the $1,400,000 paid in cash, $1,683,000 in shares of common stock and $148,000 in contingent consideration.

The Company calculated the fair value of the fixed assets based on the net book value of RVR as those approximate fair value.  The intellectual property, customer contracts and trade names were based on assumption by discounted cash flow using management estimates.  The order backlog was based on an order that RVR had at the closing, which was shipped in the first quarter of 2017, and valued at an estimated net income.

As indicated, the allocation of the purchase price and estimated useful lives of property, plant and equipment, intangible assets and deferred tax liability shown above is preliminary, pending final completion of valuations. Upon completion of this analysis, an adjustment may be required to goodwill.

For the period from January 10, 2017 to June 30, 2017, net sales and loss before income taxes from the acquisition was approximately $1,423,000 and $(150,000), respectively, which have been included in the Condensed Consolidated Statement of Operations for the six months ended June 30, 2017.  The following represents unaudited pro forma operating results as if the operations of RVR had been included in the Company's Condensed Consolidated Statements of Operations as of January 1, 2016:

Proforma table
  
For the six months ended June 30, 2016
  
Total revenues
  
$
10,158,295
  
         
Net loss
  
$
(8,643,841
)
         
Net loss per common share
  
$
(.90
)
         
Diluted net loss per common share
  
$
(.90
)

The pro forma financial information includes business combination accounting effects from the acquisition including amortization charges from acquired intangible assets of approximately $292,000. The unaudited pro forma information as presented above is for informational purposes only and is not indicative of the results of operations that would have been achieved if the acquisition had taken place at the beginning of fiscal 2016.

6
CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
NOTE 3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:

a)
Basis of Presentation:

The preceding (a) condensed consolidated balance sheet as of December 31, 2016, which has been derived from audited financial statements, and (b) the unaudited interim condensed consolidated financial statements as of June 30, 2017 and for the three and six-month periods ended June 30, 2017 and 2016, respectively, have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the "SEC"). Certain information and footnote disclosures, which are normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America, have been condensed or omitted pursuant to such rules and regulations, although we believe that the disclosures made are adequate to provide for fair presentation. The interim financial information should be read in conjunction with the Financial Statements and the notes thereto, included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2016, previously filed with the SEC.

In the opinion of management, all adjustments (which include normal recurring adjustments) necessary to present a fair statement of the Company's condensed consolidated financial position as of June 30, 2017, its condensed consolidated results of operations for the three and six-month periods ended June 30, 2017 and 2016, respectively, and its condensed consolidated cash flows for the six-month periods ended June 30, 2017 and 2016, as applicable, have been made. The interim results of operations are not necessarily indicative of the operating results for the full fiscal year or any future periods.

b)
Revenue Recognition:

The Company recognizes revenue for product sales in accordance with ASC 605, which provides that revenue is recognized when there is persuasive evidence of an arrangement, delivery has occurred or services have been rendered, the sales price is determinable, and collectability is reasonably assured. Revenue typically is recognized at time of shipment. Sales are recorded net of discounts, rebates and returns.

For certain contracts, the Company recognizes revenue from non-milestone payments and grant revenues when earned. Grants are invoiced after expenses are incurred. Revenues from projects or grants funded in advance are deferred until earned. Deferred revenues not earned were $161,356 and $392,517 as of June 30, 2017 and December 31, 2016, respectively.

The Company follows Financial Accounting Standards Board ("FASB") authoritative guidance ("guidance") prospectively for the recognition of revenue under the milestone method. The Company applies the milestone method of revenue recognition for certain collaborative research projects defining milestones at the inception of the agreement.


c)
Inventories:


Inventories consist of the following at:

   
June 30, 2017
    
December 31, 2016
  
Raw materials
  
$
2,134,288
    
$
1,824,248
  
Work in process
    
532,417
      
535,320
  
Finished goods
    
2,327,246
      
975,620
  
   
$
4,993,951
    
$
3,335,188
  

Inventories are stated net of reserves of approximately $245,000 as of June 30, 2017 and December 31, 2016.

7
CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
d)
Earnings Per Share:

Basic earnings per share is computed by dividing net income or loss by the weighted-average number of common shares outstanding for the period. Diluted income per share reflects the potential dilution from the exercise or conversion of other securities into common stock, but only if dilutive. The following securities, presented on a common share equivalent basis for the three- and six-month periods ended June 30, 2017 and 2016, have been included in the earnings per share computations:

 
For the three months ended
  
For the six months ended
 
June 30, 2017
  
June 30, 2016
  
June 30, 2017
  
June 30, 2016
Basic
  
12,299,122
    
9,667,543
    
12,284,979
    
9,649,612
                       
Diluted
  
12,299,122
    
9,667,543
    
12,284,979
    
9,649,612

As there were losses for the three and six months ended June 30, 2017 and 2016, no common share equivalents are included in the diluted per share computations.

There were 674,795 and 667,995 weighted-average number of options outstanding as of June 30, 2017 and 2016, respectively, that were not included in the calculation of diluted per common share equivalent for the three months ended June 30, 2017 and 2016 respectively, because the effect would have been anti-dilutive. There were 674,795 and 708,514 weighted-average number of options outstanding as of June 30, 2017 and 2016, respectively, that were not included in the calculation of diluted per common share equivalent for the six months ended June 30, 2017 and 2016, respectively, because the effect would have been anti-dilutive.

e)
Employee Stock Option Plans and Share-Based Compensation:

Effective June 3, 2008, the Company's stockholders voted to approve the 2008 Stock Incentive Plan ("SIP"), initially with 625,000 shares of Common Stock available to be issued. At the Annual Stockholder meeting on September 22, 2011, the Company's stockholders voted to approve an increase to the shares of Common Stock issuable under the SIP by 125,000 to 750,000. Under the terms of the SIP, the Compensation Committee of the Company's Board has the discretion to select the persons to whom awards are to be granted and the number of shares of common stock to be covered by each grant. Awards can be incentive stock options, restricted stock and/or restricted stock units. The awards become vested at such times and under such conditions as determined by the Compensation Committee at the time of the initial stock option grant. As of June 30, 2017, there were 470,724 options exercised and 264,177 options outstanding under the SIP.

Effective June 19, 2014, the Company's stockholders voted to approve the 2014 Stock Incentive Plan ("2014-SIP"), with 800,000 shares of Common Stock available to be issued. Under the terms of the 2014-SIP, the Compensation Committee of the Company's Board has the discretion to select the persons to whom awards are to be granted and the number of shares of common stock to be covered by each grant. Awards can be incentive stock options, restricted stock and/or restricted stock units. The awards become vested at such times and under such conditions as determined by the Compensation Committee at the time of the initial stock option grant. As of June 30, 2017, there were 12,000 options exercised, 203,750 options outstanding and 584,250 options or shares still available to be issued under the 2014-SIP.

There were 86,000 and 106,875 stock options granted during the six months ended June 30, 2017 and 2016, respectively.  The weighted average estimated fair value, at their respective dates of grant, of stock options granted in the six months ended June 30, 2017 and June 30, 2016, was $2.27 and $2.77 per share, respectively.  The fair value of options at the date of grant was estimated using the Black-Scholes option pricing model. The expected volatility is based upon the historical volatility of our stock. The expected term is based on historical information.


The assumptions made in calculating the fair values of options granted during the periods indicated are as follows:

 
For the three months ended
  
For the six months ended
 
June 30, 2017
  
June 30, 2016
  
June 30, 2017
  
June 30, 2016
Expected term (in years)
n/a
  
4.5
  
5.0
  
4.5 to 5.0
Expected volatility
n/a
  
43.00%
  
44.18%
  
43.00% to 48.66%
Expected dividend yield
n/a
  
0%
  
0%
  
0%
Risk-free interest rate
n/a
  
0.90%
  
1.58%
  
0.90% to 0.97%


8
CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
The Company's results for the three-month periods ended June 30, 2017 and 2016 include share-based compensation expense, consisting solely of stock options, totaling $73,700 and $92,700, respectively. Such amounts have been included in the Condensed Consolidated Statements of Operations within cost of product sales ($12,800 and none), research and development ($12,100 and $27,300, respectively) and selling, general and administrative expenses ($48,800 and $65,400, respectively). The results for the six-month periods ended June 30, 2017 and 2016 include share-based compensation expense, consisting solely of stock options, totaling approximately $209,600 and $146,200, respectively. Such amounts have been included in the Condensed Consolidated Statements of Operations within cost of product sales ($21,400 and none), research and development ($65,200 and $34,700, respectively) and selling, general and administrative expenses ($123,000 and $111,500, respectively). An operating expense, resulting in income tax benefit, has been recognized in the statement of operations for share-based compensation arrangements.

Stock option compensation expense for the three and six months ended June 30, 2017 and 2016 is based on the estimated fair value, at the date of issuance, of options outstanding, which is being amortized on a straight-line basis over the requisite service period for each vesting portion of the award. Accordingly, for stock options that vested immediately, the estimated fair value was expensed immediately.

The following table provides stock option activity for the six months ended June 30, 2017:

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
            
Forfeited/expired/cancelled
    
785
      
5.56
            
Outstanding at June 30, 2017
    
674,795
    
$
4.70
  
3.28 years
  
$
1,089,594
  
                           
Exercisable at June 30, 2017
    
383,920
    
$
4.29
  
2.76 years
  
$
727,568
  

As of June 30, 2017, there was $357,109 of net unrecognized compensation cost related to stock options that have not vested, which is expected to be recognized over a weighted average period of approximately 2.17 years. The total fair value of stock options vested during the six-month periods ended June 30, 2017 and 2016 was $128,125 and $206,701, respectively.

f)
Geographic Information:

U.S. GAAP establishes standards for the manner in which business enterprises report information about operating segments in financial statements and requires that those enterprises report selected information. It also establishes standards for related disclosures about products and services, geographic areas, and major customers.  The table below represents product revenues for different geographic regions.

   
For the three months ended
    
For the six months ended
  
   
June 30, 2017
    
June 30, 2016
    
June 30, 2017
    
June 30, 2016
  
Africa
  
$
493,852
    
$
395,231
    
$
862,679
    
$
713,989
  
Asia
    
92,596
      
88,984
      
1,513,018
      
64,005
  
Europe
    
599,435
      
205,667
      
1,040,160
      
123,096
  
North America
    
672,765
      
667,165
      
1,760,104
      
2,389,024
  
South America
    
1,034,294
      
677,025
      
3,144,353
      
4,660,977
  
   
$
2,892,942
    
$
2,034,072
    
$
8,320,314
    
$
7,951,091
  

9
CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
g)
Accounts Payable and Accrued Liabilities:

Accounts payable and accrued liabilities consist of:

   
June 30, 2017
    
December 31, 2016
  
Accounts payable – suppliers
  
$
1,823,896
    
$
1,437,290
  
Accrued commissions
    
498,974
      
221,982
  
Accrued royalties / license fees
    
389,705
      
352,660
  
Accrued payroll
    
198,507
      
167,575
  
Accrued vacation
    
312,431
      
289,587
  
Accrued bonuses
    
-
      
282,500
  
Accrued expenses – other
    
477,923
      
261,539
  
TOTAL
  
$
3,701,436
    
$
3,013,133
  

h)     Goodwill and Intangible Assets:

Goodwill represents the excess of the purchase price we paid over the fair value of the net tangible and identifiable intangible assets acquired in our acquisition of RVR in January 2017. Goodwill is not amortized but rather is tested annually for impairment or more frequently if we believe that indicators of impairment exist. Current U.S. generally accepted accounting principles permit us to make a qualitative evaluation about the likelihood of goodwill impairment. If we conclude that it is more likely than not that the fair value of a reporting unit is greater than its carrying amount, then we would not be required to perform the two-step quantitative impairment test. Otherwise, performing the two-step impairment test is necessary. The first step of the two-step quantitative impairment test involves comparing the fair values of the applicable reporting unit with its aggregate carrying value, including goodwill. If the carrying value of a reporting unit exceeds the reporting unit's fair value, we perform the second step of the test to determine the amount of the impairment loss, if any. The second step involves measuring any impairment by comparing the implied fair values of the affected reporting unit's goodwill and intangible assets with the respective carrying values.

If actual future results are not consistent with management's estimates and assumptions, we may have to take an impairment charge in the future related to our goodwill. Future impairment tests will continue to be performed annually in the fiscal first quarter, or sooner if a triggering event occurs. As of June 30, 2017, we believe no indicators of impairment exist.


Goodwill
Beginning balance 1/1/17
  
$
-
       
Acquisition of RVR
    
1,503,361
       
Changes in foreign currency exchange rate
    
67,743
       
Balance at 6/30/17
  
$
1,571,104


10
CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
In addition, the Company recorded certain intangible assets as part of the RVR acquisition which are as follows as of June 30, 2017.

Cost
    
 Accumulated Amortization 
    
June 30, 2017
Intellectual property
  
$
836,049
    $  41,802    $           794,247
Customer Contracts/relationships
    
731,543
      36,577       694,966
Order Backlog
    
209,152
      209,152       -
Trade names
    
104,506
    
4,751
       99,755
   
$
1,881,250
    $
(292,282)
    $
1,588,968


Amortization expenses for the six months ended June 30, 2017 was approximately $292,000.

i)
Recent Accounting Pronouncements Affecting the Company:

In May 2014, the FASB issued Accounting Standards Update No. 2014-09, "Revenue from Contracts with Customers" ("ASU 2014-09"), which supersedes nearly all existing revenue recognition guidance under accounting principles generally accepted in the United States ("U.S. GAAP"). The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing U.S. GAAP.

The standard is effective for annual periods beginning after December 15, 2017, and interim periods therein, using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients; or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption (which includes additional footnote disclosures). We are currently evaluating the impact of our pending adoption of ASU 2014-09 on our consolidated financial statements and have not yet determined the method by which we will adopt the standard in 2018.  The Company has conducted a preliminary analysis of its sales contracts which are based on the shipment of goods to the customer, and currently this new accounting standard will not have a material impact on its consolidated financial statements for its sales contracts.  The Company has conducted a preliminary analysis of its current R&D contracts which are currently based on an "as expenses are incurred" basis, and currently this new accounting standard will not have a material impact on its consolidated financial statements for current R&D contracts.

In November 2015, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2015-17, Income Taxes (Topic 740) Balance Sheet Classification of Deferred Assets. This ASU is intended to simplify the presentation of deferred taxes on the balance sheet and will require an entity to present all deferred tax assets and deferred tax liabilities as non-current on the balance sheet. Under the current guidance, entities are required to separately present deferred taxes as current or non-current. Netting deferred tax assets and deferred tax liabilities by tax jurisdiction will still be required under the new guidance. This guidance will be effective for Chembio beginning in 2018, with early adoption permitted. The Company does not believe this new accounting standard update will have a material impact on its consolidated financial statements.

In February 2016, the FASB issued Accounting Standards Update ("ASU") 2016-02, which amends the ASC and creates Topic 842, Leases. Topic 842 will require lessees to recognize lease assets and lease liabilities for those leases classified as operating leases under previous US GAAP on the balance sheet. This guidance is effective for annual periods beginning after December 15, 2018 and early adoption is permitted. We are in the initial stages of evaluating the effect of the standard on our financial statements and will continue to evaluate.  While not yet in a position to assess the full impact of the application of the new standard, the Company expects that the impact of recording the lease liabilities and the corresponding right-to-use assets will have a significant impact on its total assets and liabilities with a minimal impact on equity.

11
CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
In March 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2016-09, Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, which will change certain aspects of accounting for share-based payments to employees.  ASU 2016-09 is effective for fiscal years (and interim reporting periods within those years) beginning after December 15, 2016.  The Company adopted the provisions of ASU 2016-09 on January 1, 2017.  The Company evaluated this standard and the adoption of it did not have a material impact on its consolidated financial statement.

In January 2017, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2017-04 Intangibles - Goodwill and Other (Topic 350) which would eliminate the requirement to calculate the implied fair value of goodwill to measure a goodwill impairment charge. Instead, the amount of an impairment charge would be recognized if the carrying amount of a reporting unit is greater than its fair value. ASU 2017-04 is effective for public companies for fiscal years beginning after December 15, 2019.  Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017.  The Company is currently evaluating the impact of the provisions of ASU 2017-04.

NOTE 4 — COLLABORATIVE RESEARCH AND DEVELOPMENT ARRANGEMENTS:

a)
Brain Injury agreement:

In January 2015, the Company entered into a technology development agreement with Perseus Science Group LLC for $946,000 and a follow-on agreement in December 2016 for $350,000. The Company earned $233,000 and $188,000 for the six-month periods ended June 30, 2017 and 2016, respectively, from this agreement. The Company earned $1,000,000 from this grant from inception through June 30, 2017.

b)
Malaria agreement:

In April 2016, the Company was awarded a grant from the Bill & Melinda Gates Foundation for $678,000.  The Company earned  $159,000 for the six-month period ended June 30, 2017 from this agreement.  The Company earned $678,000 from this grant from inception through June 30, 2017.

c)
Fever Panel agreement:

In October 2015, the Company entered into a technology development agreement with the Paul G. Allen Ebola Program for $2,118,000 and a follow-on agreement in February 2016 for $550,000. The Company earned none and $1,560,000 for the six-month periods ended June 30, 2017 and 2016, respectively, from this agreement. The Company earned $2,668,000 from this grant from inception through June 30, 2017.

d)
BARDA Zika agreement:

In August 2016, the Company was awarded a grant for $5,934,000 from BARDA, which is part of the U.S. Department of Health And Human Resources. The Company earned $880,000 for the six-month period ended June 30, 2017 from this agreement. The Company earned $1,353,000 from this grant from inception through June 30, 2017.

e)
USDA Bovid:

In September 2016, the Company entered into a Phase II agreement with the USDA for an additional $600,000 to develop a Bovid TB assay.  The Phase I agreement was for  $100,000.  Revenue for these agreements are being recognized under a proportional performance method. The Company earned $169,000 for the six-month period ended June 30, 2017 from these agreements. The Company earned $290,000 from these agreements from inception through June 30, 2017.

f)
FIND agreement:

In March 2017, the Company entered into a technology development agreement with FIND  for $999,000. The Company earned $339,000 for the six-month period ended June 30, 2017 from this agreement. The Company earned $339,000 from this grant from inception through June 30, 2017.

12
CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
NOTE 5 — RIGHTS AGREEMENT:

In March 2016, the Company entered into a Rights Agreement dated as of March 8, 2016 (the "Rights Agreement") between the Company and Action Stock Transfer Corp., as Rights Agent. Pursuant to the Rights Agreement, the Company declared a dividend of one preferred share purchase right (a "Right") for each outstanding share of common stock, $0.01 par value (the "Common Stock"), of the Company. The Board of Directors set the payment date for the distribution of the Rights as March 8, 2016, and the Rights were distributed to the Company's shareholders of record on that date. The description and terms of the Rights are set forth in the Rights Agreement.

Rights Initially Not Exercisable. The Rights are not exercisable until a Distribution Date, which is defined below. Until a Right is exercised, the holder thereof, in his capacity as a holder of Rights, will have no rights as a shareholder of the Company, including, without limitation, the right to vote or to receive dividends.

Separation and Distribution of Rights. The Rights will be evidenced by the certificates for shares of Common Stock registered in the names of the holders thereof, and not by separate rights certificates until the earlier to occur of (i) the close of business on the tenth business day following a public announcement that an Acquiring Person (as defined in the Rights Agreement) acquired a Combined Ownership (as defined in the Rights Agreement) of 20% or more of the outstanding shares of the Common Stock (the "Shares Acquisition Date") or (ii) the later of (A) the close of business on the tenth business day (or such later date as may be determined by action of the Board of Directors prior to such time as any person or group of affiliated or associated persons becomes an Acquiring Person) after the date that a tender or exchange offer or intention to commence a tender or exchange offer by any person is first published, announced, sent or given within the meaning of Rule 14d-4(A) under the Securities Exchange Act of 1934, as amended, the consummation of which would result in any person having Combined Ownership of 20% or more of the outstanding shares of the Common Stock, or (B) if such a tender or exchange offer has been published, announced, sent or given before the date of the Rights Agreement, then the close of business on the tenth business day after the date the Rights Agreement was entered into (or such later date as may be determined by action of the Board of Directors prior to such time as any person becomes an Acquiring Person); (the earlier of such dates referred to in (i) and (ii), which date may include any such date that is after the date of the Rights Agreement but prior to the issuance of the Rights, being called the "Distribution Date").

NOTE 6 — COMMON STOCK, WARRANTS AND OPTIONS:

During the second quarter of 2017, no options were granted or exercised.

During the first quarter of 2017, options to purchase 10,969 shares of the Company's common stock were exercised on a cashless basis into 3,039 shares of common stock at an exercise price of $4.00 by surrendering options and shares of common stock already owned.

The Company completed the acquisition of RVR Diagnostics Sdn Bhd (RVR) on January 9, 2017.  Pursuant to the Stock Purchase Agreement, the Company acquired all of the issued and outstanding common stock and other equity interests of RVR from the sellers for (i) a cash payment of $1,400,000, (ii) contingent consideration of $148,000 and (iii) 269,236 shares of the Company's common stock, of which 7,277 shares are being held back to satisfy certain potential claims under the Stock Purchase Agreement and will become issuable to the Sellers, if at all, on the one-year anniversary of the closing.  The closing price of our common stock on January 9, 2017 was $6.25.

The Company entered into an employment agreement, effective as of March 13, 2017 (the "CEO Employment Agreement"), with John Sperzel to serve as the Company's Chief Executive Officer, for an additional term of three years through March 13, 2020. Pursuant to the Employment Agreement, the Company issued to Mr. Sperzel incentive and non-qualified stock options to purchase 20,000 shares of the Company's common stock. These options vest on the third anniversary or March 31, 2020. The exercise price for these options was equal to the volume weighted trading price for the Company's common stock on March 31, 2017, which was $5.3666 per share. Each option granted will expire and terminate, if not exercised sooner, upon the earlier to occur of (a) 30 days after termination of Mr. Sperzel's employment with the Company or (b) the seventh anniversary of the effective date of the grant.

During the first quarter of 2017, the Company issued options to purchase 5,000 shares of common stock to each of six members of the executive team.  The options became exercisable on the date of issue.  The options issued have an exercise price of $5.25 per share, which was  the last traded price of the common stock on the day issued.  The options expire five years from date of issue.

13
CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
During the first quarter of 2017, the Company issued options to purchase 36,000 shares of common stock to a newly-hired vice-president of operations. The options are exercisable in three equal annual installments starting on the first anniversary of the date of issue. The options issued have an exercise price of $6.30 per share, which was the last traded price of the common stock on the day issued. The options expire five years from date of issue.

During the year 2016, options to purchase 191,804 shares of the Company's common stock were exercised for cash and on a cashless basis into 125,750 shares of common stock at exercise prices ranging from $2.80 to $5.56 by surrendering options and shares of common stock already owned.

During the fourth quarter of 2016, the Company issued options to purchase 36,000 shares of common stock to a newly-hired president of the EMEA and APAC regions. The options are exercisable in three equal annual installments starting on the first anniversary of the date of issue. The options issued have an exercise price of $7.15 per share, which was the last traded price of the common stock on the day issued. The options expire five years from date of issue.

The Company closed an underwritten public offering of 2,300,000 shares of its common stock on August 3, 2016. The price per share of common stock sold in the offering was $6.00 per share. The net proceeds of the offering, after deducting the underwriters' discounts and other offering expenses payable by the Company, was approximately $12,493,000.  The Company intends to use the net proceeds for business expansion and working capital, including product development, operational improvements, clinical trials, and sales and marketing.

During the second quarter of 2016, the Company issued options to one of its directors pursuant to the Company's compensation policy for directors.  The director was issued options to purchase 46,875 shares of common stock.  The options become exercisable in five equal annual installments starting on the date of issue.  The options issued have an exercise price of $8.86 per share, which was  the last traded price of the common stock on the day issued.  The options expire five years from date of issue.

The Company entered into an employment agreement, effective as of March 5, 2016 (the "Employment Agreement"), with Javan Esfandiari to serve as the Company's Chief Scientific and Technical Officer, for an additional term of three years through March 5, 2019. Pursuant to the Employment Agreement, the Company issued to Mr. Esfandiari incentive and non-qualified stock options to purchase 60,000 shares of the Company's common stock. Of these stock options, options to purchase 20,000 shares vest on each of the first three anniversaries of March 11, 2016 which is the date on which the Employment Agreement was entered into. The exercise price for these options is equal to the trading price for the Company's common stock on March 11, 2016, which was $5.64 per share. Each option granted will expire and terminate, if not exercised sooner, upon the earlier to occur of (a) 30 days after termination of Mr. Esfandiari's employment with the Company or (b) the fifth anniversary of the effective date of the grant.

NOTE 7 — COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS:

a)
Economic Dependency:

The following table discloses product sales and accounts receivable the Company had with respect to each customer that purchased in excess of 10% of the Company's net product sales for the periods indicated:

 
For the three months ended
  
For the six months ended
  
Accounts Receivable as of
 
June 30, 2017
  
June 30, 2016
  
June 30, 2017
  
June 30, 2016
  
June 30, 2017
  
June 30, 2016
 
Sales
  
% of Sales
  
Sales
  
% of Sales
  
Sales
  
% of Sales
  
Sales
  
% of Sales
        
Customer 1
  
$
956,207
  
33
%
  
$
666,765
  
33
%
  
$
2,895,794
  
35
%
  
$
3,256,170
  
41
%
  
$
2,729,804
    
$
3,389,505
Customer 2
    
*
  
*
      
*
  
*
      
*
  
*
      
1,796,477
  
23
%
    
*
      
-
Customer 3
    
*
  
*
      
*
  
*
      
1,326,171
  
16
%
    
*
  
*
      
-
      
*
Customer 4
    
399,482
  
14
%
    
*
  
*
      
754,408
  
9
%
    
*
  
*
      
-
      
*

(*) Product sales did not exceed 10% for the period indicated.

Note that sales include product sales only while accounts receivable reflects the total due from the customer, which includes freight.

14
CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
The following table discloses purchases and accounts payable that the Company had with respect to each vendor that sold to the  Company in excess of 10% of the Company's total purchases for the periods indicated:

 
For the three months ended
  
For the six months ended
  
Accounts Payable as of
 
June 30, 2017
  
June 30, 2016
  
June 30, 2017
  
June 30, 2016
  
June 30, 2017
  
June 30, 2016
 
Purchases
  
% of Purc.
  
Purchases
  
% of Purc.
  
Purchases
  
% of Purc.
  
Purchases
  
% of Purc.
        
Vendor 1
  
$
*
  
*
    
$
203,020
  
12
%
  
$
*
  
*
    
$
425,922
  
13
%
  
$
*
    
$
60,935
Vendor 2
    
698,838
  
32
%
    
*
  
*
      
698,838
  
26
%
    
*
  
*
      
-
      
*
Vendor 3
    
204,781
  
11
%
    
*
  
*
      
*
  
*
      
*
  
*
      
29,613
      
*

(*) Purchases did not exceed 10% for the period indicated

The Company currently buys materials which are purchased under intellectual property rights agreements and are important components in its products. Management believes that other suppliers could provide similar materials on comparable terms as the vendors shown in this table. A change in suppliers, however, could cause a delay in manufacturing, either from the logistics of changing suppliers or from product changes attributable to new components, which could result in a possible loss of sales, and which could adversely affect operating results.

b)
Governmental Regulation:

All of the Company's existing and proposed diagnostic products are regulated by the United States Food and Drug Administration, United States Department of Agriculture, certain U.S., state and local agencies, and/or comparable regulatory bodies in other countries. Most aspects of development, production, and marketing, including product testing, authorizations to market, labeling, promotion, manufacturing, and record keeping, are subject to regulatory review. After marketing approval has been granted, Chembio must continue to comply with governmental regulations. Failure to comply with these regulations can result in significant penalties.

c)
Employment Agreements:

The Company has employment contracts with four key employees: CEO John J. Sperzel III; CSTO Javan Esfandiari; Managing Director of RVR Magentiren Vajuram; Vice-President of RVR Dr. Avijit Roy. The contracts call for salaries presently aggregating $1,000,000 per year. The Sperzel contract expires in March 2020, the Esfandiari contract expires in March 2019, and the Vajuram and Roy contracts expire January 9, 2018. In connection with the Sperzel contract that expires in March 2020, the Company issued, in March 2017, options to purchase 20,000 common shares of stock, which vest on the third anniversary of the grant. In connection with the Esfandiari contract that expires in March 2019, the Company issued, in March 2016, options to purchase 60,000 shares of common stock, with one-third vesting on each of the first, second and third anniversaries of the grant.

15
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The terms "Chembio", "Company", "we", "us", and "our" refer to Chembio Diagnostics, Inc. and its subsidiaries as a consolidated entity, unless the context suggests otherwise.

Overview

This discussion and analysis should be read in conjunction with the accompanying Condensed Consolidated Financial Statements and related notes. The discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States ("U.S. GAAP"). The preparation of financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of any contingent liabilities at the financial statement date, and reported amounts of revenue and expenses during the reporting period. On an ongoing basis, we review our estimates and assumptions. Our estimates are based on our historical experience and other assumptions that we believe to be reasonable under the circumstances. Actual results are likely to differ from those estimates under different assumptions or conditions, but we do not believe such differences will materially affect our financial position or results of operations. Our critical accounting policies, the policies we believe are most important to the presentation of our financial statements and require the most difficult, subjective and complex judgments, are outlined below in ''Critical Accounting Policies,'' and have not changed significantly from December 31, 2016, with the exception of goodwill.

In addition, certain statements made in this report may constitute "forward-looking statements". These forward-looking statements involve known or unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Specifically, 1) our ability to obtain necessary regulatory approvals for our products; and 2) our ability to increase revenues and operating income are dependent upon our ability to develop and sell our products, general economic conditions, and other factors. You can identify forward-looking statements by terminology such as "may," "could", "will," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "potential", "continues" or the negative of these terms, or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Except as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained in this report, as a result of new information or future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business.

All of the Company's future products that are currently being developed are based on its patented Dual Path Platform (DPP®), which is a unique diagnostic point-of-care platform that has certain advantages over lateral flow technology. The Company has completed development of several products that employ the DPP® technology which are currently marketed under Chembio's label (DPP® HIV 1/2 Screening Assay and DPP® HIV 1/2 –Syphilis Assay, which latter assay is not yet approved to be marketed in the U.S.), or which may be marketed pursuant to private label license or distribution agreements such as those with the Oswaldo Cruz Foundation ("FIOCRUZ"), Labtest, RVR and Bio-Rad.

Research and development ("R&D"), milestone, and grant revenues for the six months ended June 30, 2017 decreased to $1.79 million from $1.86 million in the prior-year period, which was primarily the result of decreased R&D project revenues in 2017.

R&D expenses in the six months ended June 30, 2017 were $4.23 million, compared with $4.00 million in the prior-year period. Development work continues on several assays utilizing Chembio's DPP® platform, including the DPP® HIV multiplex tests that are designed to detect various infectious diseases such as Zika, Malaria, Dengue and other fever diseases partially funded by projects and grants.

 
16
Research & Development Activities

Sexually Transmitted Disease
 
●
 
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 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, which are in progress and expected to be complete during the fourth quarter of 2017, in preparation for filing the Premarket Approval Application.
 
 
Fever & Tropical Disease
 
●
 
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 have recently completed the feasibility, and delivered DPP® Malaria Assays to a partner of the Bill & Melinda Gates Foundation for a lab evaluation during the third  quarter of 2017.
 
 
●
 
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 approval by the Brazilian health regulatory authority, Agência Nacional de Vigilância Sanitária (ANVISA), for the DPP® Zika IgM/IgG Assay in November 2016, and for the DPP® Micro Reader in July 2017, in collaboration with Bio-Manguinhos/Fiocruz. 
 
 
●
 
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 commercialization in Southeast Asia, and we initiated sales of our DPP® Dengue Assay in Southeast Asia during the first quarter of 2017.
 
 
17
●
 
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. Also during 2017, we initiated registration to begin initial commercialization in Southeast Asia.
 
 
●
 
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. We estimate completion of these field studies in the 3Q of 2017.
 
 
●
 
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.
 
 
Technology Collaboration
 
●
 
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 and verification of the DPP® Cancer Assay, which are 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.
 
 
18
●
 
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 is 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 is being developed in collaboration with National Animal Disease Center (NADC) and Infectious Disease Research Institute (IDRI). Under the two-year grant, Chembio is using 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 is being designed to provide results within 20 minutes, thereby significantly improving on the time-consuming, tedious and inadequate diagnostic methods currently in use.
 
 
Regulatory Activities
 
●
 
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, which are in progress and expected to be complete during the fourth quarter of 2017, in preparation for filing the Premarket Approval Application.
 
●
 
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, for the DPP® Zika IgM/IgG Assay, and in July 2017, we received ANVISA approval for the DPP® Micro Reader, in collaboration with Bio-Manguinhos.  Additionally, 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.
 
 
There can be no assurance that any of the aforementioned Research & Development and/or regulatory products or activities will result in any product approvals or commercialization, nor that any of the existing research and development activities, or any new potential development programs or collaborations will materialize or that they will meet regulatory or any other technical requirements and specifications, and/or that if continued, will result in completed products, or that such products, if they are successfully completed, can or will be successfully commercialized.

Critical Accounting Policies and Estimates
 
We believe that there are several accounting policies that are critical to understanding our historical and future performance, as these policies affect the reported amounts of revenue and the more significant areas involving management's judgments and estimates. These significant accounting policies relate to revenue recognition, research and development costs, valuation of inventory, valuation of long-lived assets, goodwill, and income taxes. For a summary of our significant accounting policies, which have not changed from December 31, 2016, see our Annual Report on Form 10-K for the twelve months ended December 31, 2016, with the exception of goodwill, which was filed with the SEC on March 7, 2017.

19
RESULTS OF OPERATIONS FOR THE THREE MONTHS ENDED JUNE 30, 2017 AS COMPARED WITH THE THREE MONTHS ENDED JUNE 30, 2016
 
 
Income:

 
For the three months ended June 30, 2017, Loss before income taxes was $2,173,000 compared to $2,385,000 for the three months ended June 30, 2016. Net Loss for the 2017 period was $2,173,000 as compared to $8,347,000 for 2016. The decrease in Net Loss is primarily attributable to recording of a full valuation of approximately 5,963,000 on our Deferred Tax Asset (DTA) in the 2016 period, an increase in product revenues, an increase in royalty revenues, and increased product gross margin, partially offset by an increase in operating expenses and decreased R&D revenues of $204,000. Product gross margin increased in the three months ended June 30, 2017, as compared with the three months ended June 30, 2016, by $341,000 or 98.03%.

Revenues:

Selected Product Categories:
  
For the three months ended
              
   
June 30, 2017
    
June 30, 2016
    
$ Change
    
% Change
  
                         
Lateral Flow HIV Tests and Components
  
$
1,598,032
    
$
1,168,759
    
$
429,273
      
36.73
%
DPP® Tests and Components
    
1,182,052
      
834,561
      
347,491
      
41.64
%
Other
    
112,858
      
30,752
      
82,106
      
266.99
%
Net Product Sales
    
2,892,942
      
2,034,072
      
858,870
      
42.22
%
License and royalty revenue
    
227,635
      
33,895
      
193,740
      
571.59
%
R&D, milestone and grant revenue
    
994,237
      
1,198,438
      
(204,201
)
    
-17.04
%
Total Revenues
  
$
4,114,814
    
$
3,266,405
    
$
848,409
      
25.97
%

Revenues for our lateral flow HIV (LF-HIV) tests and related components during the three months ended June 30, 2017 increased by approximately $429,000 from the same period in 2016. This was primarily attributable to increased sales to Europe of approximately $386,000, and Africa of approximately $103,000 partially offset by decreased sales to Latin America of approximately $49,000. Revenues for our DPP® products during the three months ended June 30, 2017 increased by approximately $347,000 over the same period in 2016, primarily due to increased sales in Brazil. The decrease in R&D, and in milestone and grant revenue, was primarily due to decreased R&D project revenues in 2017.

20
Management is also focused on sales by region as well as sales by product types.  As a result, we are providing the following table which shows sales by region and by product type.

   
For the three Months ended
           
For the three Months ended
       
Region
  
June 30, 2017
    
June 30, 2016
    
$ Change
  
Part-Type
  
June 30, 2017
    
June 30, 2016
    
$ Change
  
Africa
  
$
462,852
    
$
379,156
    
$
83,696
  
 DPP
  
$
–
    
$
18,500
    
$
(18,500
)
LF-HIV
    
463,852
      
360,636
      
103,216
  
OTHER
    
(1,000
)
    
20
      
(1,020
)
Asia
    
122,342
      
86,644
      
35,698
  
 DPP
    
2,400
      
4,400
      
(2,000
)
LF-HIV
    
88,928
      
76,274
      
12,654
  
OTHER
    
31,014
      
5,970
      
25,044
  
Europe
    
599,435
      
208,817
      
390,618
  
 DPP
    
3,350
      
–
      
3,350
  
LF-HIV
    
572,011
      
186,214
      
385,797
  
OTHER
    
24,074
      
22,603
      
1,471
  
Latin America
    
1,034,994
      
737,088
      
297,906
  
 DPP
    
953,277
      
666,765
      
286,512
  
LF-HIV
    
18,525
      
67,743
      
(49,218
)
OTHER
    
63,192
      
2,580
      
60,612
  
Other
    
1,255
      
691
      
564
  
 DPP
    
1,000
      
750
      
250
  
LF-HIV
    
255
      
(69
)
    
324
  
OTHER
    
–
      
10
      
(10
)
USA
    
672,064
      
621,676
      
50,388
  
 DPP
    
209,025
      
144,146
      
64,879
  
LF-HIV
    
454,461
      
471,910
      
(17,449
)
OTHER
    
8,578
      
5,620
      
2,958
  
TOTALS
  
$
2,892,942
    
$
2,034,072
    
$
858,870
       
$
2,892,942
    
$
2,034,072
    
$
858,870
  

Gross Margin:

 
For the three months ended
              
   
June 30, 2017
    
June 30, 2016
    
$ Change
    
% Change
  
                         
Gross Margin per Statements of Operations
  
$
1,910,971
    
$
1,580,305
    
$
330,666
      
20.92
%
Less: R&D, milestone, grant, license and royalty revenues
    
1,221,872
      
1,232,333
      
(10,461
)
    
-0.85
%
Gross Margin from Net Product Sales
  
$
689,099
    
$
347,972
    
$
341,127
      
98.03
%
Product Gross Margin %
    
23.82
%
    
17.11
%
                

The overall gross margin dollar increase of $331,000 included a $341,000 increase in gross margin from product sales and was partially offset by a $10,000 increase in non-product revenues. The increase in net product sales gross margin of $341,000 is primarily attributable to the increase in sales compared to 2016. The net product sales gross margin increase is primarily affected by two components, one is the increase in product sales of $859,000, which, at the 17.1% margin percentage for June 30, 2016, contributed $147,000 to the increase, and the other is the increased change in margin percentage of 6.71%, which contributed $194,000 to the balance of the increase in our net product sales gross margin.
21
Research and Development:

Research and development expenses include costs incurred for product development, regulatory approvals, clinical trials, and product evaluations.

Selected expense lines:
  
For the three months ended
              
   
June 30, 2017
    
June 30, 2016
    
$ Change
    
% Change
  
Clinical and Regulatory Affairs:
                        
Wages and related costs
  
$
147,692
    
$
131,472
    
$
16,220
      
12.34
%
Consulting
    
3,463
      
12,055
      
(8,592
)
    
-71.27
%
Stock-based compensation
    
-
      
-
      
-
      
100.00
%
Clinical trials
    
313,027
      
106,746
      
206,281
      
193.24
%
Other
    
13,956
      
9,723
      
4,233
      
43.54
%
Total Clinical and Regulatory Affairs
    
478,138
      
259,996
      
218,142
      
83.90
%
                                 
R&D other than Clinical Regulatory Affairs:
                                
Wages and related costs
    
733,083
      
698,385
      
34,698
      
4.97
%
Consulting
    
57,806
      
37,115
      
20,691
      
55.75
%
Stock-based compensation
    
12,101
      
27,263
      
(15,162
)
    
-55.61
%
Materials and supplies
    
492,003
      
1,244,803
      
(752,800
)
    
-60.48
%
Other
    
209,295
      
99,904
      
109,391
      
109.50
%
Total R&D other than Clinical Regulatory Affairs
    
1,504,288
      
2,107,470
      
(603,182
)
    
-28.62
%
                                 
Total Research and Development
  
$
1,982,426
    
$
2,367,466
    
$
(385,040
)
    
-16.26
%

Expenses for Clinical & Regulatory Affairs for the three months ended June 30, 2017 increased by $218,000 as compared to the same period in 2016. This was primarily due to the increase in clinical trial expenses of $206,000.

R&D expenses other than Clinical & Regulatory Affairs decreased by $603,000 in the three months ended June 30, 2017, as compared with the same period in 2016. The decreases were primarily related to an decrease in material and supplies, in order to support the decrease in our sponsored research.

Selling, General and Administrative Expenses:

Selected expense lines:
  
For the three months ended
              
   
June 30, 2017
    
June 30, 2016
    
$ Change
    
% Change
  
                         
Wages and related costs
  
$
942,795
    
$
750,624
    
$
192,171
      
25.60
%
Consulting
    
12,000
      
56,479
      
(44,479
)
    
-78.75
%
Commissions
    
85,791
      
90,299
      
(4,508
)
    
-4.99
%
Stock-based compensation
    
48,753
      
65,414
      
(16,661
)
    
-25.47
%
Marketing materials
    
72,601
      
97,704
      
(25,103
)
    
-25.69
%
Investor relations/investment bankers
    
71,623
      
81,236
      
(9,613
)
    
-11.83
%
Legal, accounting and compliance
    
397,013
      
149,247
      
247,766
      
166.01
%
Travel, entertainment and trade shows
    
173,172
      
116,725
      
56,447
      
48.36
%
Other
    
305,612
      
191,085
      
114,527
      
59.94
%
Total S, G &A
  
$
2,109,360
    
$
1,598,813
    
$
510,547
      
31.93
%

Selling, general and administrative expenses for the three months ended June 30, 2017, increased by $511,000 as compared with the same period in 2016, a 31.9% increase. This increase resulted primarily from increases in professional fees, wages and related costs due to an increase in sales staff, travel, entertainment and trade shows, and other expenses which were partially offset by decreases in stock-based compensation, marketing material, commissions, primarily due to decreased sales to Brazil,  and decreases in consulting.
22
Other Income:

 
For the three months ended
          
 
June 30, 2017
  
June 30, 2016
  
$ Change
  
% Change
  
Interest income
  
$
7,722
    
$
1,310
    
$
6,412
      
489.47
%
Total Other Income
  
$
7,722
    
$
1,310
    
$
6,412
      
489.47
%

Other income for the three months ended June 30, 2017 increased to $7,722, from an income of $1,310 in the same period in 2016, primarily as a result of interest income received as a result of more cash to invest.

Income tax provision:

The Company recorded a full valuation allowance for the three months ended June 30, 2017, on its deferred tax assets.


RESULTS OF OPERATIONS FOR THE SIX MONTHS ENDED JUNE 30, 2017 AS COMPARED WITH THE SIX MONTHS ENDED JUNE 30, 2016
 
Income:
 
For the for the six months ended June 30, 2017, Loss before income taxes was $3,789,000 compared to $2,850,000 for the for the six months ended June 30, 2016. Net Loss for the 2017 period was $3,789,000 as compared to $8,651,000 for 2016. The decrease in Net Loss is primarily attributable to recording of a full valuation of approximately 5,801,000 on our Deferred Tax Asset (DTA) in the 2016 period, an increase in product revenues, an increase in royalty revenues, and increased product gross margin, partially offset by an increase in operating expenses and decreased R&D revenues of $68,000. Product gross margin increased in the for the six months ended June 30, 2017, as compared with the for the six months ended June 30, 2016, by $ 68,000 or 2.40%.

Revenues:

Selected Product Categories:
  
For the six months ended
              
   
June 30, 2017
    
June 30, 2016
    
$ Change
    
% Change
  
                         
Lateral Flow HIV Tests and Components
  
$
3,230,046
    
$
4,225,287
    
$
(995,241
)
    
(23.55
)%
DPP® Tests and Components
    
3,400,670
      
3,492,446
      
(91,776
)
    
(2.63
)%
Other
    
1,689,598
      
233,358
      
1,456,240
      
624.04
%
Net Product Sales
    
8,320,314
      
7,951,091
      
369,223
      
4.64
%
License and royalty revenue
    
327,689
      
56,096
      
271,593
      
484.16
%
R&D, milestone and grant revenue
    
1,791,977
      
1,860,317
      
(68,340
)
    
(3.67
)%
Total Revenues
  
$
10,439,980
    
$
9,867,504
    
$
572,476
      
5.80
%

Revenues for our lateral flow HIV (LF-HIV) tests and related components for the six months ended June 30, 2017 decreased by approximately $ 995,000 from the same period in 2016. This was primarily attributable to decreased sales in the U.S. of approximately $1,257,000, decreased sales to Africa of approximately $334,000, decreased sales to Latin America of approximately $70,000 and Asia of approximately $31,000, and  partially offset by increased sales to Europe of approximately $711,000. Revenues for our DPP® products during the for the six months ended June 30, 2017 decreased by approximately $92,000 over the same period in 2016, primarily due to decreased sales in Brazil, partially offset by increased sales in the U.S.  Revenues for our other products for the six months ended June 30, 2017, increased by approximately $1,456,000, primarily as a result of sales from our Malaysia subsidiary The decrease in R&D, and in milestone and grant revenue, was primarily due to decreased R&D project revenues in 2017.

23
Management is also focused on sales by region as well as sales by product types.  As a result, we are providing the following table which shows sales by region and by product type.


   
For the six months ended
          
For the six months ended
        
Region
  
June 30, 2017
  
June 30, 2016
  
$ Change
  
Part-Type
  
June 30, 2017
    
June 30, 2016
    
$ Change
  
Africa
  
$
831,679
  
$
1,093,145
  
$
(261,466
)
 DPP
  
$
88,380
    
$
18,510
    
$
69,870
  
LF-HIV
    
740,128
      
1,074,615
      
(334,487
)
OTHER
    
3,171
      
20
      
3,151
  
Asia
    
1,542,709
    
147,022
    
1,395,687
  
 DPP
    
7,400
      
4,400
      
3,000
  
LF-HIV
    
105,327
      
136,442
      
(31,115
)
OTHER
    
1,429,982
      
6,180
      
1,423,802
  
Europe
    
1,040,160
    
331,913
    
708,247
  
 DPP
    
3,850
      
250
      
3,600
  
LF-HIV
    
1,010,810
      
299,856
      
710,954
  
OTHER
    
25,500
      
31,807
      
(6,307
)
Latin America
    
3,145,108
    
3,415,993
    
(270,885
)
 DPP
    
2,896,844
      
3,256,170
      
(359,326
)
LF-HIV
    
58,210
      
127,743
      
(69,533
)
OTHER
    
190,054
      
32,080
      
157,974
  
Other
    
1,255
    
4,318
    
(3,063
)
 DPP
    
1,000
      
750
      
250
  
LF-HIV
    
255
      
3,556
      
(3,301
)
OTHER
    
0
      
12
      
(12
)
USA
    
1,759,403
    
2,958,700
    
(1,199,297
)
 DPP
    
390,196
      
212,365
      
177,831
  
LF-HIV
    
1,315,371
      
2,572,611
      
(1,257,240
)
OTHER
    
53,836
      
173,724
      
(119,888
)
TOTALS
  
$
8,320,314
  
$
7,951,091
  
$
369,223
       
$
8,320,314
    
$
7,951,091
    
$
369,223
  

Gross Margin:

 
For the six months ended
              
   
June 30, 2017
    
June 30, 2016
    
$ Change
    
% Change
  
                         
Gross Margin per Statements of Operations
  
$
5,016,923
    
$
4,745,853
    
$
271,070
      
5.71
%
Less: R&D, milestone, grant, license and royalty revenues
    
2,119,666
      
1,916,413
      
203,253
      
10.61
%
Gross Margin from Net Product Sales
  
$
2,897,257
    
$
2,829,440
    
$
67,817
      
2.40
%
Product Gross Margin %
    
34.82
%
    
35.59
%
                

The overall gross margin dollar increase of $271,000 included a $68,000 increase in gross margin from product sales and a $203,000 increase in non-product revenues. The increase in net product sales gross margin of $68,000 is primarily attributable to the increase in sales compared to 2016. The net product sales gross margin increase is primarily affected by two components, one is the increase in product sales of $369,000, which, at the 35.59% margin percentage for June 30, 2016, contributed $131,000 to the increase, and the other is the decreased change in margin percentage of 0.76%, which contributed $64,000 to the balance of the increase in our net product sales gross margin.
 
24
Research and Development:

Research and development expenses include costs incurred for product development, regulatory approvals, clinical trials, and product evaluations.

Selected expense lines:
  
For the six months ended
              
   
June 30, 2017
    
June 30, 2016
    
$ Change
    
% Change
  
Clinical and Regulatory Affairs:
                        
Wages and related costs
  
$
279,805
    
$
264,042
    
$
15,763
      
5.97
%
Consulting
    
3,463
      
16,451
      
(12,988
)
    
(78.95
)%
Stock-based compensation
    
9,652
      
-
      
9,652
      
100.00
%
Clinical trials
    
785,972
      
158,841
      
627,131
      
394.82
%
Other
    
24,614
      
23,423
      
1,191
      
5.08
%
Total Clinical and Regulatory Affairs
    
1,103,506
      
462,757
      
640,749
      
138.46
%
                                 
R&D other than Clinical Regulatory Affairs:
                                
Wages and related costs
    
1,459,405
      
1,438,416
      
20,989
      
1.46
%
Consulting
    
106,814
      
42,775
      
64,039
      
149.71
%
Stock-based compensation
    
55,558
      
34,720
      
20,838
      
60.02
%
Materials and supplies
    
1,166,060
      
1,805,036
      
(638,976
)
    
(35.40
)%
Other
    
337,655
      
218,060
      
119,595
      
54.84
%
Total R&D other than Clinical Regulatory Affairs
    
3,125,492
      
3,539,007
      
(413,515
)
    
(11.68
)%
                                 
Total Research and Development
  
$
4,228,998
    
$
4,001,764
    
$
227,234
      
5.68
%

Expenses for Clinical & Regulatory Affairs for the six months ended June 30, 2017 increased by $641,000 as compared to the same period in 2016. This was primarily due to the increase in clinical trial expenses of $627,000.

R&D expenses other than Clinical & Regulatory Affairs decreased by $414,000 for the six months ended June 30, 2017, as compared with the same period in 2016. The decreases were primarily related to a decrease in material and supplies, in order to support the decrease in our sponsored research.

Selling, General and Administrative Expenses:

Selected expense lines:
  
For the six months ended
              
   
June 30, 2017
    
June 30, 2016
    
$ Change
    
% Change
  
                         
Wages and related costs
  
$
1,863,861
    
$
1,564,873
    
$
298,988
      
19.11
%
Consulting
    
21,425
      
118,223
      
(96,798
)
    
(81.88
)%
Commissions
    
317,515
      
406,279
      
(88,764
)
    
(21.85
)%
Stock-based compensation
    
123,050
      
111,545
      
11,505
      
10.31
%
Marketing materials
    
179,674
      
147,837
      
31,837
      
21.54
%
Investor relations/investment bankers
    
141,245
      
164,162
      
(22,917
)
    
(13.96
)%
Legal, accounting and compliance
    
698,280
      
481,363
      
216,917
      
45.06
%
Travel, entertainment and trade shows
    
341,523
      
207,209
      
134,314
      
64.82
%
Other
    
911,123
      
396,726
      
514,397
      
129.66
%
Total S, G &A
  
$
4,597,696
    
$
3,598,217
    
$
999,479
      
27.78
%

Selling, general and administrative expenses for the six months ended June 30, 2017, increased by $999,000 as compared with the same period in 2016, a 27.78% increase. This increase resulted primarily from increases in wages and related costs due to an increase in sales staff, professional fees, travel, entertainment and trade shows, stock-based compensation, and other expenses, primarily due to expenses from our Malaysian subsidiary, which were partially offset by decreases in commissions, primarily due to decreased sales to Brazil,  and decreases in consulting.
 
25
Other Income:

 
For the six months ended
          
 
June 30, 2017
  
June 30, 2016
  
$ Change
  
% Change
  
Interest income
  
$
21,104
    
$
3,874
    
$
17,230
      
444.76
%
Total Other Income
  
$
21,104
    
$
3,874
    
$
17,230
      
444.76
%

Other income for the six months ended June 30, 2017 increased to $ 21,104, from an income of $ 3,874 in the same period in 2016, primarily as a result of interest income received as a result of more cash to invest.
 
Income tax provision:

The Company recorded a full valuation allowance for the six months ended June 30, 2017, on its deferred tax assets.


MATERIAL CHANGES IN FINANCIAL CONDITION

Selected Changes in Financial Condition
  
As of
              
   
June 30, 2017
    
December 31, 2016
    
$ Change
    
% Change
  
Cash and cash equivalents
  
$
3,691,783
    
$
10,554,464
    
$
(6,862,681
)
    
-65.02
%
Accounts receivable, net of allowance for doubtful accounts of $52,000 at June 30, 2017 and December 31, 2016, respectively
    
4,671,627
      
3,383,729
      
1,287,898
      
38.06
%
Inventories, net
    
4,993,951
      
3,335,188
      
1,658,763
      
49.74
%
Fixed assets, net of accumulated depreciation
    
2,093,494
      
1,709,321
      
384,173
      
22.48
%
Deposits on manufacturing equipment
    
51,573
      
31,900
      
19,673
      
61.67
%
Deposits and other assets
    
156,089
      
720,489
      
(564,400
)
    
-78.34
%
Prepaid expenses and other current assets
    
777,688
      
840,145
      
(62,457
)
    
-7.43
%
Goodwill
    
1,571,104
      
-
      
1,571,104
      
100.00
%
Intangible assets, net
    
1,588,968
      
-
      
1,588,968
      
100.00
%
Accounts payable and accrued liabilities
    
3,701,436
      
3,013,133
      
688,303
      
22.84
%
Deferred revenue
    
161,356
      
392,517
      
(231,161
)
    
-58.89
%

Cash decreased by $6,863,000 from December 31, 2016, primarily due to cash used in operating activities and cash used in investing activities, primarily for the acquisition in RVR, for the six months of 2017. In addition, there were increases in accounts receivable of $1,288,000 (primarily due to a large customer as described under "Liquidity And Capital Resources"), inventories of $1,659,000, net fixed assets of $384,000, deposits on manufacturing equipment of $20,000, an increase in accounts payable and accrued liabilities of $688,000, and increases in goodwill and intangible assets of $1,571,000 and $1,589,000, respectively due to the RVR acquisition.  We experienced a decrease in deposits and other assets of $564,000, primarily from reducing the deposit paid for the RVR acquisition, prepaid expenses, net of amortization, of  $62,000, and a decrease in deferred revenue of $231,000.

26
LIQUIDITY AND CAPITAL RESOURCES

   
For the six months ended
              
   
June 30, 2017
    
June 30, 2016
    
$ Change
    
% Change
  
 
                        
Net cash used in operating activities
  
$
(5,456,787
)
  
$
(3,856,555
)
  
$
(1,600,232
)
    
41.49
%
Net cash used in investing activities
    
(1,405,894
)
    
(85,877
)
    
(1,320,017
)
    
1,537.10
%
Net cash provided by financing activities
    
-
      
5,370
      
(5,370
)
    
-100.00
%
DECREASE IN CASH AND CASH EQUIVALENTS
  
$
(6,862,681
)
  
$
(3,937,062
)
  
$
(2,925,619
)
    
74.31
%

The Company's cash decreased as of June 30, 2017 by $6,863,000 from December 31, 2016, primarily due to cash used in operating activities, and net cash used in investing activities, primarily for the RVR acquisition, for the first six months of 2017.

The cash used in operations in the first six months of 2017 was $5,457,000, which consisted primarily of an increase in accounts receivable of $1,288,000, an increase in prepaid expenses of $25,000 (net of amortization), increase in inventories of $1,659,000, a decrease in deferred revenue of $231,000, and a net loss net of non-cash items of $2,805,000, partially offset by cash provided by an increase in accounts payable and accrued liabilities of $543,000. Net loss net of non-cash items includes loss before income taxes of $3,789,000 reduced by non-cash expenses of $774,000 in depreciation and amortization, and of $210,000 in share-based non-cash compensation. The use of cash from investing activities is primarily due to the acquisition of RVR for $1,400,000 in cash, of which $850,000 was paid in the six months ended June 30, 2017, and partially offset by reduction in deposit for RVR investment of $550,000 for a deposit paid in December of 2016.

The Company currently has positive working capital.  It has used approximately $6.9 million in cash for the six months ended June 30, 2017, primarily due to cash used in operating activities. Approximately $2.7 million of the total $4.7 million of accounts receivable is related to one customer, and the Company has a high degree of confidence that this account receivable is collectible from this customer.

On June 27, 2017, the Company entered into a Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co., as sales agent, pursuant to which the Company may offer and sell, from time to time, through Cantor Fitzgerald, shares of the Company's common stock, par value $0.01 per share, having an aggregate offering price of up to $21.2 million. The Company is not obligated to sell any shares under the Sales Agreement.

Fixed Asset Commitments

As of June 30, 2017, the Company had $51,573 in deposits on equipment, and $61,120 in commitments for additional equipment purchase obligations.
 
27
RECENT DEVELOPMENTS AND CHEMBIO'S PLAN OF OPERATIONS FOR THE NEXT TWELVE MONTHS
 
During the second quarter of 2017, Chembio continued to execute its transition strategy, with a focus in three key areas: 1) strengthening the Company's core sexually transmitted disease business, 2) building a broad tropical and fever disease portfolio, and 3) establishing a global commercial team. 
 
Market research indicates that the Company has significant opportunities in our core sexually transmitted disease business, including the commercialization of a U.S. version of the DPP® HIV-Syphilis Assay, as well as the DPP®HIV Self-Testing kits, outside the U.S., specifically in Africa and Europe. It also supports large market opportunities can be addressed with its fever and tropical disease assays, including DPP® Malaria, DPP® Dengue, DPP® Zika, and the DPP® Fever Assays. Commercially, Chembio now has sales executives in target regions, including the U.S., Latin America, Africa, Europe and Asia Pacific, and this global sales infrastructure is beginning to produce results.
 
Sexually Transmitted Diseases Business
 
To strengthen the Company's core sexually transmitted disease business, Chembio continues to focus on its DPP® HIV-Syphilis Assay in response to the global concerns related to co-infection and mother-to-child transmission of both HIV and syphilis.  The World Health Organization recommends screening all pregnant women for HIV and syphilis at the first antenatal care visit in nearly all countries of the world. Early diagnosis and treatment of both HIV and syphilis in pregnant women have been proven effective in the prevention of both adverse outcomes of pregnancy and mother-to-child transmission.  Additionally, men who have sex with men (MSM), transgender people, injection drug users and sex workers may also benefit from improved HIV and syphilis screening coverage. Chembio's DPP® HIV-Syphilis Assay is currently available in Latin America, Europe and the Caribbean (except for Puerto Rico).
 
In the U.S., Chembio is currently in clinical trials to support its Premarket Approval Application (PMA) with the Food and Drug Administration (FDA) for the DPP® HIV-Syphilis Assay, which the Company expects to complete during the fourth quarter of 2017.
 
Also in the U.S. market, the Company won, during the last two quarters, a number of HIV state and county rapid test awards for the procurement of tests, much of which we expect to realize over the next 18 months.  We believe that an increasing number of customers are turning to Chembio to address their needs for an easy-to-use, high quality, and affordable HIV rapid test, with a minimum of 12-month shelf life.
 
Outside the U.S., Chembio's DPP® Syphilis Screen & Confirm Assay, which is CE Marked, is now available.  The DPP® Syphilis Screen & Confirm Assay has been successfully used in several pilot programs in Africa, and is the only rapid test that can detect both active and past-treated syphilis infections with the same test. We believe this product presents an opportunity for Chembio to create a paradigm shift in syphilis confirmatory testing outside of the U.S.
 
Another important milestone for this business, Chembio recently secured a $5.8 million order to supply, during 2017, test components and intermediate product for the production of DPP® HIV 1/2 Assays, both blood and oral fluid, in Brazil, for the subsequent supply to Brazil's Ministry of Health. The Company shipped $0.9 million of this order during the second quarter of 2017 and anticipates shipping the remaining $4.9 million during the third and fourth quarters of 2017.
 
There also has been significant progress by Chembio in the HIV Self-Testing arena, as evidenced by our strong sales in the EU.  We believe the market for HIV Self-Testing, in Africa and Europe, offers significant growth potential, and we believe our HIV products are well-suited to penetrate these markets.
 
Tropical and Fever Disease Business
 
At the beginning of 2017, Chembio stated the goal of commercializing multiple tropical and fever disease products during the year.  The Company has already initiated sales of its DPP® Dengue Assay and DPP® Zika Assay through a pilot program with the Centers for Disease Control and Prevention (CDC) for the Company's DPP® Dengue/Zika/Chikungunya Assay in India, Peru, Haiti and Guatemala.
 
28
Also during the second quarter, Chembio added to our accomplishments in this business by entering into a new collaboration with FIND and receiving a key regulatory approval for its DPP® Micro Reader from the Brazilian health regulatory agency. 
 
Through the Company's new collaboration with FIND, Chembio will work to develop a POC test that can identify multiple life-threatening acute febrile illnesses common in the Asia Pacific region. Similar to the Company's DPP® Fever Panel developed to simultaneously detect multiple fever diseases prevalent in Africa, the objective of this new panel will be to simultaneously detect multiple serious fever diseases afflicting Asia including four Plasmodium species of Malaria, Dengue, Zika, Chikungunya, Leptospirosis, Rickettsia typhi, Burkholderia pseudomallei, and Orientia tsutsugamushi.  Simultaneous detection, or multiplexing, is critical in these areas as many of these diseases present with similar symptoms, which often complicates and delays a correct diagnosis.  Chembio's DPP® technology is the only rapid, cost-effective, point-of-care diagnostic platform capable of simultaneously detecting multiple diseases from a single, small patient sample, and we both fever panels have the potential to significantly improve patient care in these regions through accurate and early diagnosis. 
 
In July 2017, Chembio received approval for its DPP® Micro Reader from Agência Nacional de Vigilância Sanitária (ANVISA), the Brazilian health regulatory agency, in collaboration with Bio-Manguinhos/Fiocruz. The DPP® Zika Assay detects antibodies using only 10uL of blood from the fingertip and provides quantitative results in 15 minutes, when used with the handheld, battery-operated DPP® Micro Reader.  With this approval, Chembio's DPP® Zika System, which includes the DPP® Zika Assay and DPP® Micro Reader, is now approved for commercial use in Brazil. 
 
The Company continues to pursue additional regulatory approvals for the DPP® Zika Assay, including U.S. FDA Emergency Use Authorization, and World Health Organization Emergency Use Assessment And Listing.  We remain optimistic, given the performance of our DPP® Zika Assay. 
 
It is important to note that nearly all of the Company's fever and tropical disease products are being developed through collaborations and/or funding from world-leading health organizations including, the Bill & Melinda Gates Foundation, the Paul G. Allen Family Foundation, the CDC, FIND, and BARDA.
 
Global Commercialization
 
In mid-2014, Chembio made a strategic decision to transform from a product supply organization to an integrated commercial organization, and began building a sales and marketing team in the U.S. market. At that time, the Company terminated its distribution agreements with a former U.S. distributor, in 2014 and 2016, respectively.
 
During the fourth quarter of 2016, we strengthened the commercial leadership, appointing seasoned executives to lead the Americas region, as well as the European, Middle East and Africa (EMEA) and Asia Pacific regions. And, during the first quarter of 2017, we added experienced diagnostics sales executives in Latin America, Africa and Asia Pacific. We believe this infrastructure positions the Company for commercial success, globally.  
 
Additionally, Chembio has integrated its newly acquired facility in Malaysia, to execute upon our global commercialization strategy, which includes the manufacture of tests locally, in high growth regions where product performance and competitive pricing is key.  The Company is also planning investments in automation of our DPP® manufacturing line to produce high quality, reliable, products that can be scaled rapidly.  As a key part of this strategy and process, the Company hired David Gyorke, Chembio's Vice President of Operations, in January 2017 to drive manufacturing strategy to support growth.
 
Board Appointment
 
In corporate matters, subsequent to the end of the second quarter, Chembio announced the appointment of Gail Page to the Company's Board of Directors. Ms. Page has spent her entire career in health care with a focus on diagnostics and emerging technologies. In January 2013, Ms. Page founded Vineyard Investment Advisors (VIA), through which she works with entrepreneurs, businesses, and universities to transform their ideas into products and services. Prior to VIA, Ms. Page served as the President, CEO and a Director of Vermillion, Inc., a healthcare company focused on developing and commercializing novel diagnostic blood tests. As President and CEO, Ms. Page directed Vermillion's repositioning to highlight the progressive nature of its pipeline, successfully raised over $100M in funding, developed and commercially launched the OVA1® Test, which was the first FDA-cleared blood test to help diagnose ovarian cancer, and engaged Quest Diagnostics as an equity and commercial partner. In the years preceding Vermillion, Ms. Page served as Executive Vice President and Chief Operating Officer at Luminex, and as Sr. Vice President at Roche Biomedical / Laboratory Corporation of America (LabCorp), during which time her team launched approximately 300 innovative tests, including a suite of HIV and infectious disease assays. Ms. Page's current board appointments include Sword Diagnostics, Inc., Consortia Health Holdings (Chair and Co-founder), and NxPrenatal, Inc., for which she serves as Executive Chair. 
29
Overview of Chembio's Global Sales:
 
During the second quarter of 2017, Chembio achieved total revenue of $4.1 million, which represents a 26% increase over the second quarter of 2016.  Product sales during the second quarter of 2017 were $2.9 million, which represents a 42.2% increase over the prior year period.  This increase was driven primarily by significant product sales growth within our target regions compared to the prior year period, including a 187.1% increase in Europe, a 41.2% increase in Asia Pacific, a 40.4% increase in Latin America, a 22.1% increase in Africa, and an 8.1% increase in the U.S.
 
The increase in product revenue during the second quarter can be attributed to the efforts of our expanding sales and marketing organization and the new channels they are opening in our target regions.  In Latin America, we achieved sales in excess of $1.0 million led by strong DPP® sales, including our Chagas STAT-PAK® Assay, which is the only rapid test validated for Chagas and used as part of the algorithm for testing in Bolivia.  In the U.S., the Company achieved over $0.7 million in sales, as we evolve from a product supply organization to direct sales of our three FDA PMA approved, CLIA-waived HIV rapid tests, serving both public health and the professional market.  And in Europe, the Company recognized revenue of approximately $0.6 million, driven primarily by HIV sales for self-testing, followed by Africa with sales of $0.5 million.
 
Conclusion:
 
In conclusion, we believe the achievements during the second quarter of 2017 demonstrate Chembio's commitment and progress toward strengthening its core business in the sexually transmitted disease market, building a broad fever and tropical disease portfolio, and establishing a global commercial team.
 
During the quarter, the Company continued to make progress toward the launch of our DPP® HIV-Syphilis Assay in the U.S. market, secured a significant $5.8 million DPP® HIV order in Brazil, and won a number of HIV tenders in the U.S, which we expect to ship over the next 12-15 months. In addition, the Company has initiated sales of DPP® Tropical and Fever Disease products in multiple new markets, and we believe sales of our Tropical and Fever Disease Assays will continue to grow.   We also have successfully established Chembio commercial teams in the U.S., Latin America, Asia Pacific and Africa, with necessary investments in manufacturing to support growth.


30

 
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 June 30, 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.  On January 9, 2017, the Company acquired all the outstanding stock of RVR Diagnostics Sdn Bhd ("RVR"), which became a wholly-owned subsidiary of the Company as a result of the acquisition.  This report on controls does not include controls and procedures concerning RVR.

(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 six months ended June 30, 2017 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.


31
PART II. OTHER INFORMATION

ITEM 6.  EXHIBITS

EXHIBITS INDEX
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
 
31.1
 
31.2
 
32
 
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 27, 2017.
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.

32

________________________________________________________________________

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.



 
     Chembio Diagnostics, Inc.
     
     
     
Date:
August 9, 2017
By: /s/ Sharon Klugewicz
 
 
Sharon Klugewicz
 
 
acting Chief Executive Officer
(Principal Executive Officer)
 
 
 
     
     
     
Date:
August 9, 2017
By: /s / Richard J. Larkin
 
 
Richard J. Larkin
 
 
Chief Financial Officer
(Principal Financial and Accounting Officer)


33
 EX-31.1 2 ex31_1q.htm CEO CERT  
EXHIBIT 31.1
 
CERTIFICATION
 
 
I, Sharon Klugewicz, certify that:
 
1. I have reviewed this Form 10-Q of Chembio Diagnostics, Inc.;
 
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
 
5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
 
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
 
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
 
 

 
Date: August 9, 2017 /s/ Sharon Klugewicz
Sharon Klugewicz, acting Chief Executive Officer
 EX-31.2 3 ex31_2q.htm CFO CERT  
EXHIBIT 31.2
 
CERTIFICATION
 
I, Richard J. Larkin, certify that:
1. I have reviewed this Form 10-Q of Chembio Diagnostics, Inc.;
 
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
 
5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
 
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
 
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
 
 

 
Date:  August 9, 2017 /s/ Richard J. Larkin
Richard J. Larkin, Chief Financial Officer

 EX-32 4 ex32q.htm SECTION 906 CERT  
EXHIBIT 32

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q (the "Report") of Chembio Diagnostics, Inc. (the "Company") for the quarter ended June 30, 2017, each of the undersigned Sharon Klugewicz, the acting Chief Executive Officer of the Company, and Richard J. Larkin, the Chief Financial Officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of the undersigneds' knowledge and belief:

(1) This Form 10-Q for the quarter ended June 30, 2017 fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in this Form 10-Q for the quarter ended June 30, 2017 fairly presents, in all material respects, the financial condition and results of operations of Chembio Diagnostics, Inc. for the periods presented therein.



Dated:  August 9, 2017 /s/ Sharon Klugewicz
Sharon Klugewicz
Chief Executive Officer


Dated:  August 9, 2017 /s/ Richard J. Larkin
Richard J. Larkin
Chief Financial Officer


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Certain information and footnote disclosures, which are normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America, have been condensed or omitted pursuant to such rules and regulations, although we believe that the disclosures made are adequate to provide for fair presentation. 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text-align: justify;">As there were losses for the three and six months ended June 30, 2017 and 2016, no common share equivalents are included in the diluted per share computations.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">There were 674,795 and 667,995 weighted-average number of options outstanding as of June 30, 2017 and 2016, respectively, that were not included in the calculation of diluted per common share equivalent for the three months ended June 30, 2017 and 2016 respectively, because the effect would have been anti-dilutive. There were 674,795 and 708,514 weighted-average number of options outstanding as of June 30, 2017 and 2016, respectively, that were not included in the calculation of diluted per common share equivalent for the six months ended June 30, 2017 and 2016, respectively, because the effect would have been anti-dilutive.</div><div><br /></div><div style="text-align: left;"><table cellpadding="0" cellspacing="0" class="DSPFListTable" style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; width: 100%;"><tr><td style="width: 46.8pt;"></td><td style="font-size: 10pt; font-family: 'Times New Roman'; width: 18pt; vertical-align: top; font-weight: bold; font-style: italic; align: right;">e)</td><td style="width: auto; vertical-align: top; text-align: left;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; font-style: italic;">Employee Stock Option Plans and Share-Based Compensation:</div></td></tr></table></div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">Effective June 3, 2008, the Company's stockholders voted to approve the 2008 Stock Incentive Plan ("SIP"), initially with 625,000 shares of Common Stock available to be issued. At the Annual Stockholder meeting on September 22, 2011, the Company's stockholders voted to approve an increase to the shares of Common Stock issuable under the SIP by 125,000 to 750,000. Under the terms of the SIP, the Compensation Committee of the Company's Board has the discretion to select the persons to whom awards are to be granted and the number of shares of common stock to be covered by each grant. Awards can be incentive stock options, restricted stock and/or restricted stock units. The awards become vested at such times and under such conditions as determined by the Compensation Committee at the time of the initial stock option grant. 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text-align: left;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; font-style: italic;">Recent Accounting Pronouncements Affecting the Company:</div></td></tr></table></div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">In May 2014, the FASB issued Accounting Standards Update No. 2014-09, "Revenue from Contracts with Customers" ("ASU 2014-09"), which supersedes nearly all existing revenue recognition guidance under accounting principles generally accepted in the United States ("U.S. GAAP"). The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. 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We are currently evaluating the impact of our pending adoption of ASU 2014-09 on our consolidated financial statements and have not yet determined the method by which we will adopt the standard in 2018.&#160; The Company has conducted a preliminary analysis of its sales contracts which are based on the shipment of goods to the customer, and currently this new accounting standard will not have a material impact on its consolidated financial statements for its sales contracts.&#160; The Company has conducted a preliminary analysis of its current R&amp;D contracts which are currently based on an "as expenses are incurred" basis, and currently this new accounting standard will not have a material impact on its consolidated financial statements for current R&amp;D contracts.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">In November 2015, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2015-17, Income Taxes (Topic 740) Balance Sheet Classification of Deferred Assets. 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Certain information and footnote disclosures, which are normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America, have been condensed or omitted pursuant to such rules and regulations, although we believe that the disclosures made are adequate to provide for fair presentation. 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font-family: 'Times New Roman'; text-align: justify;">The Company currently buys materials which are purchased under intellectual property rights agreements and are important components in its products. Management believes that other suppliers could provide similar materials on comparable terms as the vendors shown in this table. A change in suppliers, however, could cause a delay in manufacturing, either from the logistics of changing suppliers or from product changes attributable to new components, which could result in a possible loss of sales, and which could adversely affect operating results.</div><div><br /></div><div style="text-align: left;"><table cellpadding="0" cellspacing="0" class="DSPFListTable" style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; width: 100%;"><tr><td style="width: 46.8pt;"></td><td style="font-size: 10pt; font-family: 'Times New Roman'; width: 18pt; vertical-align: top; font-weight: bold; font-style: italic; align: right;">b)</td><td style="width: auto; vertical-align: top; text-align: left;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; font-style: italic;">Governmental Regulation:</div></td></tr></table></div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">All of the Company's existing and proposed diagnostic products are regulated by the United States Food and Drug Administration, United States Department of Agriculture, certain U.S., state and local agencies, and/or comparable regulatory bodies in other countries. Most aspects of development, production, and marketing, including product testing, authorizations to market, labeling, promotion, manufacturing, and record keeping, are subject to regulatory&#160;review. After marketing approval has been granted, Chembio must continue to comply with governmental regulations. 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font-size: 10pt;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: left; margin-right: 36pt;">NOTE 1 &#8212; DESCRIPTION OF BUSINESS:</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">Chembio Diagnostics, Inc. (the "Company" or "Chembio") and its wholly-owned subsidiaries, Chembio Diagnostic Systems Inc., and RVR Diagnostics Sdn Bhd ("RVR"), develop, manufacture, and market rapid diagnostic tests that detect infectious diseases. The Company's main lateral flow products are three rapid tests for the detection of HIV antibodies in whole blood, serum and plasma samples, two of which were approved by the FDA in 2006; the third is sold for export only. In addition, the Company has several products based on its patented Dual Path Platform (DPP&#174;) technology, including a HIV test approved by the FDA in 2013 and CLIA-Waived in 2014. Lateral Flow Rapid HIV tests represented 39% of the Company's product revenues in the first six months of 2017. The Company's products based on its DPP&#174; platform represented approximately 41% of the Company's product revenues in the first six months of 2017. The Company also has other rapid tests and components that together represented approximately 20% of product sales in the first six months of 2017. The Company's products are sold to medical laboratories and hospitals, governmental and public health entities, non-governmental organizations, medical professionals and retail establishments, both domestically and internationally. Chembio's products are sold under the Company's STAT PAK&#174;, SURE CHECK&#174;, STAT-VIEW&#174; or DPP&#174; registered trademarks, or under the private labels of its marketing partners. 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The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing U.S. GAAP.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">The standard is effective for annual periods beginning after December 15, 2017, and interim periods therein, using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients; or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption (which includes additional footnote disclosures). We are currently evaluating the impact of our pending adoption of ASU 2014-09 on our consolidated financial statements and have not yet determined the method by which we will adopt the standard in 2018.&#160; The Company has conducted a preliminary analysis of its sales contracts which are based on the shipment of goods to the customer, and currently this new accounting standard will not have a material impact on its consolidated financial statements for its sales contracts.&#160; The Company has conducted a preliminary analysis of its current R&amp;D contracts which are currently based on an "as expenses are incurred" basis, and currently this new accounting standard will not have a material impact on its consolidated financial statements for current R&amp;D contracts.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">In November 2015, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2015-17, Income Taxes (Topic 740) Balance Sheet Classification of Deferred Assets. This ASU is intended to simplify the presentation of deferred taxes on the balance sheet and will require an entity to present all deferred tax assets and deferred tax liabilities as non-current on the balance sheet. Under the current guidance, entities are required to separately present deferred taxes as current or non-current. Netting deferred tax assets and deferred tax liabilities by tax jurisdiction will still be required under the new guidance. This guidance will be effective for Chembio beginning in 2018, with early adoption permitted. The Company does not believe this new accounting standard update will have a material impact on its consolidated financial statements.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: left;"><font style="font-size: 10pt; font-family: 'Times New Roman';">In February 2016, the FASB issued Accounting Standards Update ("ASU") 2016-02, which amends the ASC and creates Topic 842, Leases. Topic 842 will require lessees to recognize lease assets and lease liabilities for those leases classified as operating leases under previous US GAAP on the balance sheet. This guidance is effective for annual periods beginning after December 15, 2018 and early adoption is permitted. </font><font style="font-size: 10pt; font-family: 'Times New Roman';">We are in the initial stages of evaluating the effect of the standard on our financial statements and will continue to evaluate.&#160; </font><font style="font-size: 10pt; font-family: 'Times New Roman';">While not yet in a position to assess the full impact of the application of the new standard, the Company expects that the impact of recording the lease liabilities and the corresponding right-to-use assets will have a significant impact on its total assets and liabilities with a minimal impact on equity.</font></div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: left;">In March 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2016-09, Compensation &#8211; Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, which will change certain aspects of accounting for share-based payments to employees.&#160; ASU 2016-09 is effective for fiscal years (and interim reporting periods within those years) beginning after December 15, 2016.&#160; The Company adopted the provisions of ASU 2016-09 on January 1, 2017.&#160; The Company evaluated this standard and the adoption of it did not have a material impact on&#160;its consolidated financial statement.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">In January 2017, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2017-04 <font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic;">Intangibles - Goodwill and Other (Topic 350) </font>which would eliminate the requirement to calculate the implied fair value of goodwill to measure a goodwill impairment charge. 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The Company earned $233,000 and $188,000 for the six-month periods ended June 30, 2017 and 2016, respectively, from this agreement. The Company earned $1,000,000 from this grant from inception through June 30, 2017.</div><div><br /></div><div style="text-align: left;"><table cellpadding="0" cellspacing="0" class="DSPFListTable" style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; width: 100%;"><tr><td style="width: 46.8pt;"></td><td style="font-size: 10pt; font-family: 'Times New Roman'; width: 18pt; vertical-align: top; font-weight: bold; font-style: italic; align: right;">b)</td><td style="width: auto; vertical-align: top; text-align: left;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; font-style: italic;">Malaria agreement:</div></td></tr></table></div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">In April 2016, the Company was awarded a grant from the Bill &amp; Melinda Gates Foundation for $678,000.&#160; The Company earned&#160; $159,000 for the six-month period ended June 30, 2017 from this agreement.&#160; The Company earned $678,000 from this grant from inception through June 30, 2017.</div><div><br /></div><div style="text-align: left;"><table cellpadding="0" cellspacing="0" class="DSPFListTable" style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; width: 100%;"><tr><td style="width: 46.8pt;"></td><td style="font-size: 10pt; font-family: 'Times New Roman'; width: 18pt; vertical-align: top; font-weight: bold; font-style: italic; align: right;">c)</td><td style="width: auto; vertical-align: top; text-align: left;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; font-style: italic;">Fever Panel agreement:</div></td></tr></table></div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">In October 2015, the Company entered into a technology development agreement with the Paul G. Allen Ebola Program for $2,118,000 and a follow-on agreement in February 2016 for $550,000. The Company earned none and $1,560,000 for the six-month periods ended June 30, 2017 and 2016, respectively, from this agreement. 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The Company earned $880,000 for the six-month period ended June 30, 2017 from this agreement. 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vertical-align: bottom; text-align: right; background-color: #cceeff;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;">1,463,052</div></td><td nowrap="nowrap" valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #cceeff;">&#160;</td></tr><tr><td valign="bottom" style="width: 24.5%; vertical-align: bottom; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 14%; vertical-align: bottom; text-align: right; background-color: #ffffff;">&#160;</td><td nowrap="nowrap" valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 14%; vertical-align: bottom; text-align: right; background-color: #ffffff;">&#160;</td><td nowrap="nowrap" valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 24.5%; vertical-align: bottom; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 14%; vertical-align: bottom; text-align: right; background-color: #ffffff;">&#160;</td><td nowrap="nowrap" valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td></tr><tr><td valign="bottom" style="width: 24.5%; vertical-align: bottom; background-color: #cceeff;"><div style="font-size: 10pt; 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text-indent: -12pt;">Other intangible assets (estimated useful life):</div></td><td valign="bottom" style="width: 1%; vertical-align: bottom; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 14%; vertical-align: bottom; text-align: right; background-color: #ffffff;">&#160;</td><td nowrap="nowrap" valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td></tr><tr><td valign="bottom" style="width: 83%; vertical-align: top; background-color: #cceeff;"><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: left; margin-left: 60pt; text-indent: -12pt;">Intellectual property (approximate 10 year weighted average)</div></td><td valign="bottom" style="width: 1%; vertical-align: bottom; background-color: #cceeff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; 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font-size: 10pt;"><div style="text-align: left;"><table cellpadding="0" cellspacing="0" class="DSPFListTable" style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; width: 100%;"><tr><td style="width: 46.8pt;"></td><td style="font-size: 10pt; font-family: 'Times New Roman'; width: 18pt; vertical-align: top; font-weight: bold; font-style: italic; align: right;">e)</td><td style="width: auto; vertical-align: top; text-align: left;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; font-style: italic;">Employee Stock Option Plans and Share-Based Compensation:</div></td></tr></table></div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">Effective June 3, 2008, the Company's stockholders voted to approve the 2008 Stock Incentive Plan ("SIP"), initially with 625,000 shares of Common Stock available to be issued. At the Annual Stockholder meeting on September 22, 2011, the Company's stockholders voted to approve an increase to the shares of Common Stock issuable under the SIP by 125,000 to 750,000. Under the terms of the SIP, the Compensation Committee of the Company's Board has the discretion to select the persons to whom awards are to be granted and the number of shares of common stock to be covered by each grant. Awards can be incentive stock options, restricted stock and/or restricted stock units. The awards become vested at such times and under such conditions as determined by the Compensation Committee at the time of the initial stock option grant. 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Pursuant to the Employment Agreement, the Company issued to Mr. Sperzel incentive and non-qualified stock options to purchase 20,000 shares of the Company's common stock. These options vest on the third anniversary or March 31, 2020. The exercise price for these options was equal to the volume weighted trading price for the Company's common stock on March 31, 2017, which was $5.3666 per share. 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Increase (Decrease) in Deposit Assets Changes in assets and liabilities: Prepaid expenses and other current assets Increase (Decrease) in Prepaid Expense and Other Assets Additional stock options (in shares) Incremental Common Shares Attributable to Dilutive Effect of Share-based Payment Arrangements Interest expense Interest Expense Inventories Inventory, Policy [Policy Text Block] Inventories, net Inventories Inventory, Net Finished goods Inventory valuation reserves Inventory Valuation Reserves Inventories [Abstract] Work in process Raw materials Interest income TOTAL LIABILITIES Liabilities TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY Liabilities and Equity LIABILITIES AND STOCKHOLDERS' EQUITY LIABILITIES AND STOCKHOLDERS' EQUITY OTHER LIABILITIES: TOTAL CURRENT LIABILITIES Liabilities, Current CURRENT LIABILITIES: License and Royalty Revenue Major Customers [Axis] Maximum [Member] Minimum [Member] North America [Member] Name of Major Customer [Domain] DESCRIPTION OF BUSINESS Nature 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Title of Individual [Axis] Trade Names [Member] Vice President [Member] Vice President [Member] Weighted average number of shares outstanding, diluted (in shares) Diluted (in shares) Summary of weighted average shares used for computation of basic and diluted earnings per share [Abstract] Summary of common share equivalent basis, used in diluted per share computations [Abstract] Weighted average number of shares outstanding, basic (in shares) Basic (in shares) Carrying value of deposit amounts on manufacturing equipment. Deposits on manufacturing equipment Value of deposits on manufacturing equipment transferred to fixed assets in noncash transactions during the period. Deposits on manufacturing equipment transferred to fixed assets The current portion of money or property received from customers which is either to be returned upon satisfactory contract completion or applied to customer receivables in accordance with the terms of the contract or the understandings. The carrying amount of consideration received or receivable as of the balance sheet date on potential earnings that were not recognized as revenue in conformity with GAAP, and which are expected to be recognized as such within one year or the normal operating cycle, if longer, including sales, license fees, and royalties, but excluding interest income. Customer deposits and deferred revenue of operating activities Customer deposits and deferred revenue Refers to accrual of contingent earn out payment during the period. Accrual Of Contingent Earn Out Payment Accrual of contingent earn-out Revenue earned during the period from research and development milestones when those milestones are reached and non-milestone contracts and grants when earned. R&D, milestone and grant revenue Expiration period of stock option in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Share Based Compensation Arrangement By Share Based Payment Award Award Expiration Period Expiration period of stock option This element represents minimum period after termination of employment to exercise stock options by employees. Minimum Period After Termination Of Employment To Exercise Stock Options By Employees Minimum period after termination of employment to exercise stock options by employees Represents number of equal annual installments with in which options are exercisable. Number of equal annual installments with in which options are exercisable Number of equal annual installments with in which options are exercisable Refers to number of director for whom stock option were issued. Number of Director Stock Option Issued Number of directors, stock option issued Refers to number of executive for whom stock option were issued. Number of Executive for Stock Option Issued Number of executives, stock option issued A business acquisition, which was completed on January 9, 2017. RVR Diagnostics Sdn Bhd [Member] Number of shares held back to satisfy certain potential claims under the stock purchase agreement and can become issuable on the one year anniversary of the closing. Business Acquisition Equity Interests Held Back Number Of Shares Shares held back (in shares) Refers to shares of common stock issued on cashless basis. Common Stock Shares Issued On Cashless Basis Common stock exercised on cashless basis (in shares) Refers to product development for fever panel. Fever Panel [Member] Development Project for USDA Bovid Phase I. USDA Bovid Phase I [Member] USDA Bovid Phase I [Member] Represents maximum amount of development agreement. Maximum amount of development agreement Maximum amount of development agreement Revenue earned from the inception from non-repayable sum of money awarded to an entity to carry out a specific purpose as provided in grant agreements. Revenue from Grants from Inception Revenue from grants from inception Development Project for USDA Bovid Phase II. USDA Bovid Phase II [Member] USDA Bovid Phase II [Member] Development Project for Brain Brain [Member] Refers to development project for malaria. Malaria [Member] Malaria [Member] Development Project for BARDA GRANT. BARDA [Member] Development Project for FIND-Fever. FIND-Fever [Member] FIND [Member] Development Project for USDA Bovid. USDA Bovid [Member] USDA Bovid [Member] Refers to Klugewicz contract, which expires on May 2017. Klugewicz Contract One [Member] Klugewicz Contract Expires on May 2017 [Member] Economic Dependency [Abstract] A customer that accounts for 10 percent or more of the entity's revenues. Customer 2 [Member] A customer that accounts for 10 percent or more of the entity's revenues. Customer 1 [Member] A customer that accounts for 10 percent or more of the entity's revenues. Customer 3 [Member] Employment Agreements [Abstract] Employment Agreement [Abstract] The number of key employees with whom the Company has employment contracts. Number of key employees with whom Company has employment contracts Number of key employees with whom Company has employment contracts A party from whom the goods or services were or are to be received. Supplier 2 [Member] Vendor 2 [Member] A party from whom the goods or services were or are to be received. Supplier 1 [Member] Vendor 1 [Member] Aggregate amount of annual salaries called for by the employment contracts. Aggregate annual salaries of employment contracts Aggregate annual salaries of employment contracts A customer that accounts for 10 percent or more of the entity's revenues. Customer4 [Member] A customer that accounts for 10 percent or more of the entity's revenues. Customer5 [Member] Sperzel contract Sperzel contract [Member] Sperzel Contract [Member] Klugewicz contract Klugewicz contract [Member] Klugewicz Contract [Member] Esfandiari contract Esfandiari contract [Member] Esfandiari Contract [Member] Supplier 3 Supplier3 [Member] Vendor 3 [Member] RIGHTS AGREEMENT [Abstract] The entire disclosure for the reporting entity's rights agreement. RIGHTS AGREEMENT [Text Block] RIGHTS AGREEMENT Other rapid tests that are sold by the Company. Other rapid tests [Member] Other Rapid Tests [Member] Lateral Flow Rapid HIV tests that are sold by the Company. Lateral Flow Rapid HIV tests [Member] Lateral Flow Rapid HIV Tests [Member] Products based on its patented DPP platform that are sold by the Company. Products based on patented DPP platform [Member] Patented DPP Platform [Member] Minimum percentage of the Combined Ownership of the outstanding shares of Common Stock by Acquiring Person for the evidence of the Rights to be the rights certificate. Minimum Combined Ownership of outstanding shares of Common Stock by Acquiring Person Minimum combined ownership of outstanding shares of common stock by acquiring person A stock incentive plan ("SIP14") established on June 19, 2014 by the Company. Under the terms of the SIP14, the Compensation Committee of the Company's Board has the discretion to select the persons to whom awards are to be granted and the number of shares of common stock to covered by each grant. Awards can be incentive stock options, restricted stock and/or restricted stock units. The awards become vested at such times and under such conditions as determined by the Compensation Committee. 2014 Stock Incentive Plan [Member] A stock incentive plan ("SIP") established on June 3, 2008 by the Company. Under the terms of the SIP, the Compensation Committee of the Company's Board has the discretion to select the persons to whom awards are to be granted and the number of shares of common stock to covered by each grant. Awards can be incentive stock options, restricted stock and/or restricted stock units. The awards become vested at such times and under such conditions as determined by the Compensation Committee. Stock Incentive Plan 2008 [Member] 2008 Stock Incentive Plan [Member] Disclosure of accounting policy for accounts payable and accrued liabilities. Accounts Payable and Accrued Liabilities, Policy [Policy Text Block] Accounts Payable and Accrued Liabilities Document and Entity Information [Abstract] Amount of payment that the sellers can receive based upon sales during the annual period. Cash Milestone Payment Cash milestone payment Refers to the discounted percentage of milestone payments during the period. Milestone Payments Discounted percentage Discounted percentage Refers to the amount of maximum overage to actual sales used to determine milestone proration amount. Maximum overage To Actual Sales Maximum overage Refers to the percentage of milestone payments during the period. Percentage Of Milestone Payments Percentage of milestone payments Refers to the cash portion of milestone payments done during the period. Cash Portion Of Milestone Payment Cash portion of milestone payment Refers to the actual sales used to determine milestone proration amount. Actual Sales To Determine Milestone Proration Amount Actual sales to determine Milestone Proration Amount Refers to the accrual amount arising due to the business combination. Business Combination Accrual Amount Amount accrued Amount of stock that the sellers can receive based upon sales during the annual period. Stock Milestone Payment Stock milestone payment (in shares) Refers to purchase price of estimated fair value of common stock. Business Combination Estimated Fair Value Of Common Stock Estimated value of common stock Refers to the actual sales achieved used to determine milestone proration amount. Actual Sales Achieved To Determine Milestone Proration Amount Actual sales achieved Entity's established relationships with its customers through contracts and customer relationship that exists between an entity and its customer, for example, but not limited to, tenant relationships. 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Document and Entity Information - shares
 6 Months Ended
Jun. 30, 2017
Aug. 04, 2017
Document and Entity Information [Abstract]    
Entity Registrant Name Chembio Diagnostics, Inc.  
Entity Central Index Key 0001092662  
Current Fiscal Year End Date --12-31  
Entity Well-known Seasoned Issuer No  
Entity Voluntary Filers No  
Entity Current Reporting Status Yes  
Entity Filer Category Accelerated Filer  
Entity Common Stock, Shares Outstanding   12,309,122
Document Fiscal Year Focus 2017  
Document Fiscal Period Focus Q2  
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Jun. 30, 2017  
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CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) - USD ($)
Jun. 30, 2017
Dec. 31, 2016
CURRENT ASSETS:    
Cash and cash equivalents $ 3,691,783 $ 10,554,464
Accounts receivable, net of allowance for doubtful accounts of $52,000 at June 30, 2017 and December 31, 2016, respectively 4,671,627 3,383,729
Inventories, net 4,993,951 3,335,188
Prepaid expenses and other current assets 777,688 840,145
TOTAL CURRENT ASSETS 14,135,049 18,113,526
FIXED ASSETS, net of accumulated depreciation 2,093,494 1,709,321
OTHER ASSETS:    
Goodwill 1,571,104 0
Intangible assets, net 1,588,968 0
Deposits on manufacturing equipment 51,573 31,900
Deposits and other assets 156,088 720,489
TOTAL ASSETS 19,596,276 20,575,236
CURRENT LIABILITIES:    
Accounts payable and accrued liabilities 3,701,436 3,013,133
Deferred revenue 161,356 392,517
TOTAL CURRENT LIABILITIES 3,862,792 3,405,650
OTHER LIABILITIES:    
Deferred tax liability 335,990 0
TOTAL LIABILITIES 4,198,782 3,405,650
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY:    
Preferred stock - 10,000,000 shares authorized; none outstanding 0 0
Common stock - $.01 par value; 100,000,000 shares authorized; 12,299,122 and 12,026,847 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively 122,991 120,268
Additional paid-in capital 62,611,394 60,721,783
Accumulated other comprehensive loss 124,241 0
Accumulated deficit (47,461,132) (43,672,465)
TOTAL STOCKHOLDERS' EQUITY 15,397,494 17,169,586
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 19,596,276 $ 20,575,236
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CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (Parenthetical) - USD ($)
Jun. 30, 2017
Dec. 31, 2016
CURRENT ASSETS:    
Accounts receivable, allowance for doubtful accounts $ 52,000 $ 52,000
STOCKHOLDERS' EQUITY:    
Preferred stock - shares authorized (in shares) 10,000,000 10,000,000
Preferred stock - shares outstanding (in shares) 0 0
Common stock - par value (in dollars per share) $ 0.01 $ 0.01
Common stock - shares authorized (in shares) 100,000,000 100,000,000
Common stock - shares issued (in shares) 12,299,122 12,026,847
Common stock - shares outstanding (in shares) 12,299,122 12,026,847
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($)
 3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
REVENUES:        
Net product sales $ 2,892,942 $ 2,034,072 $ 8,320,314 $ 7,951,091
License and Royalty Revenue 227,635 33,895 327,689 56,096
R&D, milestone and grant revenue 994,237 1,198,438 1,791,977 1,860,317
TOTAL REVENUES 4,114,814 3,266,405 10,439,980 9,867,504
Cost of product sales 2,203,843 1,686,100 5,423,057 5,121,651
GROSS MARGIN 1,910,971 1,580,305 5,016,923 4,745,853
OPERATING EXPENSES:        
Research and development expenses 1,982,426 2,367,466 4,228,998 4,001,764
Selling, general and administrative expenses 2,109,360 1,598,813 4,597,696 3,598,217
TOTAL OPERATING EXPENSES 4,091,786 3,966,279 8,826,694 7,599,981
LOSS FROM OPERATIONS (2,180,815) (2,385,974) (3,809,771) (2,854,128)
OTHER INCOME:        
Interest income 7,722 1,310 21,104 3,874
TOTAL OTHER INCOME 7,722 1,310 21,104 3,874
LOSS BEFORE INCOME TAXES (2,173,093) (2,384,664) (3,788,667) (2,850,254)
Income tax provision 0 5,962,818 0 5,800,818
NET LOSS $ (2,173,093) $ (8,347,482) $ (3,788,667) $ (8,651,072)
Basic loss per share (in dollars per share) $ (0.18) $ (0.86) $ (0.31) $ (0.90)
Diluted loss per share (in dollars per share) $ (0.18) $ (0.86) $ (0.31) $ (0.90)
Weighted average number of shares outstanding, basic (in shares) 12,299,122 9,667,543 12,284,979 9,649,612
Weighted average number of shares outstanding, diluted (in shares) 12,299,122 9,667,543 12,284,979 9,649,612
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CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (UNAUDITED) - USD ($)
 3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (UNAUDITED) [Abstract]        
Net loss $ (2,173,093) $ (8,347,482) $ (3,788,667) $ (8,651,072)
Foreign currency translation adjustments 124,241 0 124,241 0
Comprehensive income $ (2,048,852) $ (8,347,482) $ (3,664,426) $ (8,651,072)
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)
 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
CASH FLOWS FROM OPERATING ACTIVITIES:    
Cash received from customers and grants $ 8,920,921 $ 8,176,364
Cash paid to suppliers and employees (14,398,812) (12,036,793)
Interest received 21,104 3,874
Net cash used in operating activities (5,456,787) (3,856,555)
CASH FLOWS FROM INVESTING ACTIVITIES:    
Payment for net assets of business acquired (850,000) 0
Acquisition of and deposits on fixed assets (555,894) (85,877)
Net cash used in investing activities (1,405,894) (85,877)
CASH FLOWS FROM FINANCING ACTIVITIES:    
Net cash provided by financing activities 0 5,370
DECREASE IN CASH AND CASH EQUIVALENTS (6,862,681) (3,937,062)
Cash and cash equivalents - beginning of the period 10,554,464 5,376,931
Cash and cash equivalents - end of the period 3,691,783 1,439,869
RECONCILIATION OF NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES:    
Net Loss (3,788,667) (8,651,072)
Adjustments:    
Depreciation and amortization 773,566 580,159
Deferred taxes 0 5,800,818
Share based compensation 209,609 146,265
Changes in assets and liabilities:    
Accounts receivable (1,287,898) (2,156,582)
Inventories (1,658,763) 96,206
Prepaid expenses and other current assets (25,043) (46,226)
Deposits and other assets 8,729 1,505
Accounts payable and accrued liabilities 542,841 (93,070)
Customer deposits and deferred revenue (231,161) 465,442
Net cash used in operating activities (5,456,787) (3,856,555)
Supplemental disclosures for non-cash investing and financing activities:    
Deposits on manufacturing equipment transferred to fixed assets 174,399 43,590
Accrual of contingent earn-out 148,000 0
Issuance of common stock for net assets of business acquired $ 1,682,725 $ 0
XML 17 R7.htm IDEA: XBRL DOCUMENT v3.7.0.1
DESCRIPTION OF BUSINESS
 6 Months Ended
Jun. 30, 2017
DESCRIPTION OF BUSINESS [Abstract]  
DESCRIPTION OF BUSINESS
NOTE 1 — DESCRIPTION OF BUSINESS:

Chembio Diagnostics, Inc. (the "Company" or "Chembio") and its wholly-owned subsidiaries, Chembio Diagnostic Systems Inc., and RVR Diagnostics Sdn Bhd ("RVR"), develop, manufacture, and market rapid diagnostic tests that detect infectious diseases. The Company's main lateral flow products are three rapid tests for the detection of HIV antibodies in whole blood, serum and plasma samples, two of which were approved by the FDA in 2006; the third is sold for export only. In addition, the Company has several products based on its patented Dual Path Platform (DPP®) technology, including a HIV test approved by the FDA in 2013 and CLIA-Waived in 2014. Lateral Flow Rapid HIV tests represented 39% of the Company's product revenues in the first six months of 2017. The Company's products based on its DPP® platform represented approximately 41% of the Company's product revenues in the first six months of 2017. The Company also has other rapid tests and components that together represented approximately 20% of product sales in the first six months of 2017. The Company's products are sold to medical laboratories and hospitals, governmental and public health entities, non-governmental organizations, medical professionals and retail establishments, both domestically and internationally. Chembio's products are sold under the Company's STAT PAK®, SURE CHECK®, STAT-VIEW® or DPP® registered trademarks, or under the private labels of its marketing partners. All of the Company's products that are currently being developed are based on its patented DPP®, which is a unique diagnostic point-of-care platform that has certain advantages over lateral flow technology.
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ACQUISITION OF RVR DIAGNOSTICS SDN BHD
 6 Months Ended
Jun. 30, 2017
ACQUISITION OF RVR DIAGNOSTICS SDN BHD [Abstract]  
ACQUISITION OF RVR DIAGNOSTICS SDN BHD
NOTE 2 — ACQUISITION OF RVR DIAGNOSTICS SDN BHD:

On January 9, 2017, pursuant to a stock purchase agreement (the "Stock Purchase Agreement), the Company acquired all of the outstanding common stock of RVR Diagnostics Sdn Bhd, a Malaysia corporation ("RVR"), for $3,231,000, utilizing some of the proceeds from the funds raised by the Company in August 2016, the issuance of Chembio's common stock, and a contingent consideration, as described below, related to RVR reaching a milestone based on revenues that was valued at $148,000.  RVR is a privately-held Malaysia based manufacturing company focused on assembly and sales of rapid medical assays.  The Company acquired RVR to have a better presence in Asia, access to lower cost, shorter approval time of in-country regulatory approvals, and a lower cost assembly operation.

Pursuant to the Stock Purchase Agreement, the Company acquired all of the issued and outstanding common stock and other equity interests of RVR for (i) a cash payment of $1,400,000, of which $550,000 was paid as a deposit in December 2016 and (ii) 269,236 shares of Chembio's common stock, with a value at closing of $1,683,000, of which 7,277 shares are being held back to satisfy certain potential claims under the Stock Purchase Agreement and will become issuable to the sellers, if at all, on the one-year anniversary of the closing.

In addition, the Stock Purchase Agreement provides that the sellers may become entitled to receive certain milestone payments based on the achievement of performance goals related to sales by RVR during the 12 months ending December 31, 2017. RVR's actual sales during that period will be used to determine the "Milestone Proration Amount," which is a fraction that (i) the numerator of which is the positive amount, if any, by which actual sales for calendar year 2017 are greater than $2,250,000, up to a maximum overage of $250,000, and (ii) the denominator of which is $250,000. Based on the actual sales achieved by RVR, the Sellers will be entitled to receive (i) a cash milestone payment equal to $100,000 multiplied by the Milestone Proration Amount, for a maximum cash milestone payment of $100,000, and (ii) a stock milestone payment equal to 21,830 shares of Chembio common stock multiplied by the Milestone Proration Amount, with a maximum stock milestone payment of 21,830 shares of Chembio common stock.  As of March 31, 2017 the Company accrued $148,000 for the milestone.  This amount is the estimated value of the common stock of $85,000 based on the assumption of reaching the milestone of 74.5% and discounted by 15%, as well as the cash portion of the milestone payment valued at $63,000.  There was no change in the fair value of this contingent milestone payment through June 30, 2017.

As a result of the consideration paid exceeding the preliminary fair value of the net assets acquired, goodwill in the amount of $1,503,361 was recorded in connection with this acquisition, none of which will be deductible for tax purposes. In addition, the Company recorded $1,800,000 in intangible assets, which results largely from the addition of RVR's intellectual property, customer base and distribution channels, trade names, order backlog, industry reputation, and management talent and workforce. Our Condensed Consolidated Statements of Operations for the six months ended June 30, 2017 include $25,000 of transaction costs related to the RVR acquisition, which are reflected as general and administrative expenses.
 
The acquisition was accounted for using the purchase method of accounting.  The following table summarizes the preliminary allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed on the closing date of January 9, 2017:

 
 
PRELIMINARY
 
    
Property, plant and equipment
 
$
235,141
 
Goodwill
  
1,503,361
 
Deferred tax liability
  
(307,636
)
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
 

* Total consideration includes the $1,400,000 paid in cash, $1,683,000 in shares of common stock and $148,000 in contingent consideration.

The Company calculated the fair value of the fixed assets based on the net book value of RVR as those approximate fair value.  The intellectual property, customer contracts and trade names were based on assumption by discounted cash flow using management estimates.  The order backlog was based on an order that RVR had at the closing, which was shipped in the first quarter of 2017, and valued at an estimated net income.

As indicated, the allocation of the purchase price and estimated useful lives of property, plant and equipment, intangible assets and deferred tax liability shown above is preliminary, pending final completion of valuations. Upon completion of this analysis, an adjustment may be required to goodwill.

For the period from January 10, 2017 to June 30, 2017, net sales and loss before income taxes from the acquisition was approximately $1,423,000 and $(150,000), respectively, which have been included in the Condensed Consolidated Statement of Operations for the six months ended June 30, 2017.  The following represents unaudited pro forma operating results as if the operations of RVR had been included in the Company's Condensed Consolidated Statements of Operations as of January 1, 2016:

Proforma table
 
For the six months ended June 30, 2016
 
Total revenues
 
$
10,158,295
 
     
Net loss
 
$
(8,643,841
)
     
Net loss per common share
 
$
(.90
)
     
Diluted net loss per common share
 
$
(.90
)

The pro forma financial information includes business combination accounting effects from the acquisition including amortization charges from acquired intangible assets of approximately $292,000. The unaudited pro forma information as presented above is for informational purposes only and is not indicative of the results of operations that would have been achieved if the acquisition had taken place at the beginning of fiscal 2016.
XML 19 R9.htm IDEA: XBRL DOCUMENT v3.7.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 6 Months Ended
Jun. 30, 2017
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
NOTE 3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:

a)
Basis of Presentation:

The preceding (a) condensed consolidated balance sheet as of December 31, 2016, which has been derived from audited financial statements, and (b) the unaudited interim condensed consolidated financial statements as of June 30, 2017 and for the three and six-month periods ended June 30, 2017 and 2016, respectively, have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the "SEC"). Certain information and footnote disclosures, which are normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America, have been condensed or omitted pursuant to such rules and regulations, although we believe that the disclosures made are adequate to provide for fair presentation. The interim financial information should be read in conjunction with the Financial Statements and the notes thereto, included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2016, previously filed with the SEC.

In the opinion of management, all adjustments (which include normal recurring adjustments) necessary to present a fair statement of the Company's condensed consolidated financial position as of June 30, 2017, its condensed consolidated results of operations for the three and six-month periods ended June 30, 2017 and 2016, respectively, and its condensed consolidated cash flows for the six-month periods ended June 30, 2017 and 2016, as applicable, have been made. The interim results of operations are not necessarily indicative of the operating results for the full fiscal year or any future periods.

b)
Revenue Recognition:

The Company recognizes revenue for product sales in accordance with ASC 605, which provides that revenue is recognized when there is persuasive evidence of an arrangement, delivery has occurred or services have been rendered, the sales price is determinable, and collectability is reasonably assured. Revenue typically is recognized at time of shipment. Sales are recorded net of discounts, rebates and returns.

For certain contracts, the Company recognizes revenue from non-milestone payments and grant revenues when earned. Grants are invoiced after expenses are incurred. Revenues from projects or grants funded in advance are deferred until earned. Deferred revenues not earned were $161,356 and $392,517 as of June 30, 2017 and December 31, 2016, respectively.

The Company follows Financial Accounting Standards Board ("FASB") authoritative guidance ("guidance") prospectively for the recognition of revenue under the milestone method. The Company applies the milestone method of revenue recognition for certain collaborative research projects defining milestones at the inception of the agreement.


c)
Inventories:


Inventories consist of the following at:

  
June 30, 2017
  
December 31, 2016
 
Raw materials
 
$
2,134,288
  
$
1,824,248
 
Work in process
  
532,417
   
535,320
 
Finished goods
  
2,327,246
   
975,620
 
  
$
4,993,951
  
$
3,335,188
 

Inventories are stated net of reserves of approximately $245,000 as of June 30, 2017 and December 31, 2016.

d)
Earnings Per Share:

Basic earnings per share is computed by dividing net income or loss by the weighted-average number of common shares outstanding for the period. Diluted income per share reflects the potential dilution from the exercise or conversion of other securities into common stock, but only if dilutive. The following securities, presented on a common share equivalent basis for the three- and six-month periods ended June 30, 2017 and 2016, have been included in the earnings per share computations:

 
For the three months ended
 
For the six months ended
 
June 30, 2017
 
June 30, 2016
 
June 30, 2017
 
June 30, 2016
Basic
 
12,299,122
  
9,667,543
  
12,284,979
  
9,649,612
            
Diluted
 
12,299,122
  
9,667,543
  
12,284,979
  
9,649,612

As there were losses for the three and six months ended June 30, 2017 and 2016, no common share equivalents are included in the diluted per share computations.

There were 674,795 and 667,995 weighted-average number of options outstanding as of June 30, 2017 and 2016, respectively, that were not included in the calculation of diluted per common share equivalent for the three months ended June 30, 2017 and 2016 respectively, because the effect would have been anti-dilutive. There were 674,795 and 708,514 weighted-average number of options outstanding as of June 30, 2017 and 2016, respectively, that were not included in the calculation of diluted per common share equivalent for the six months ended June 30, 2017 and 2016, respectively, because the effect would have been anti-dilutive.

e)
Employee Stock Option Plans and Share-Based Compensation:

Effective June 3, 2008, the Company's stockholders voted to approve the 2008 Stock Incentive Plan ("SIP"), initially with 625,000 shares of Common Stock available to be issued. At the Annual Stockholder meeting on September 22, 2011, the Company's stockholders voted to approve an increase to the shares of Common Stock issuable under the SIP by 125,000 to 750,000. Under the terms of the SIP, the Compensation Committee of the Company's Board has the discretion to select the persons to whom awards are to be granted and the number of shares of common stock to be covered by each grant. Awards can be incentive stock options, restricted stock and/or restricted stock units. The awards become vested at such times and under such conditions as determined by the Compensation Committee at the time of the initial stock option grant. As of June 30, 2017, there were 470,724 options exercised and 264,177 options outstanding under the SIP.

Effective June 19, 2014, the Company's stockholders voted to approve the 2014 Stock Incentive Plan ("2014-SIP"), with 800,000 shares of Common Stock available to be issued. Under the terms of the 2014-SIP, the Compensation Committee of the Company's Board has the discretion to select the persons to whom awards are to be granted and the number of shares of common stock to be covered by each grant. Awards can be incentive stock options, restricted stock and/or restricted stock units. The awards become vested at such times and under such conditions as determined by the Compensation Committee at the time of the initial stock option grant. As of June 30, 2017, there were 12,000 options exercised, 203,750 options outstanding and 584,250 options or shares still available to be issued under the 2014-SIP.

There were 86,000 and 106,875 stock options granted during the six months ended June 30, 2017 and 2016, respectively.  The weighted average estimated fair value, at their respective dates of grant, of stock options granted in the six months ended June 30, 2017 and June 30, 2016, was $2.27 and $2.77 per share, respectively.  The fair value of options at the date of grant was estimated using the Black-Scholes option pricing model. The expected volatility is based upon the historical volatility of our stock. The expected term is based on historical information.


The assumptions made in calculating the fair values of options granted during the periods indicated are as follows:

 
For the three months ended
 
For the six months ended
 
June 30, 2017
 
June 30, 2016
 
June 30, 2017
 
June 30, 2016
Expected term (in years)
n/a
 
4.5
 
5.0
 
4.5 to 5.0
Expected volatility
n/a
 
43.00%
 
44.18%
 
43.00% to 48.66%
Expected dividend yield
n/a
 
0%
 
0%
 
0%
Risk-free interest rate
n/a
 
0.90%
 
1.58%
 
0.90% to 0.97%


The Company's results for the three-month periods ended June 30, 2017 and 2016 include share-based compensation expense, consisting solely of stock options, totaling $73,700 and $92,700, respectively. Such amounts have been included in the Condensed Consolidated Statements of Operations within cost of product sales ($12,800 and none), research and development ($12,100 and $27,300, respectively) and selling, general and administrative expenses ($48,800 and $65,400, respectively). The results for the six-month periods ended June 30, 2017 and 2016 include share-based compensation expense, consisting solely of stock options, totaling approximately $209,600 and $146,200, respectively. Such amounts have been included in the Condensed Consolidated Statements of Operations within cost of product sales ($21,400 and none), research and development ($65,200 and $34,700, respectively) and selling, general and administrative expenses ($123,000 and $111,500, respectively). An operating expense, resulting in income tax benefit, has been recognized in the statement of operations for share-based compensation arrangements.

Stock option compensation expense for the three and six months ended June 30, 2017 and 2016 is based on the estimated fair value, at the date of issuance, of options outstanding, which is being amortized on a straight-line basis over the requisite service period for each vesting portion of the award. Accordingly, for stock options that vested immediately, the estimated fair value was expensed immediately.

The following table provides stock option activity for the six months ended June 30, 2017:

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
      
Forfeited/expired/cancelled
  
785
   
5.56
      
Outstanding at June 30, 2017
  
674,795
  
$
4.70
 
3.28 years
 
$
1,089,594
 
              
Exercisable at June 30, 2017
  
383,920
  
$
4.29
 
2.76 years
 
$
727,568
 

As of June 30, 2017, there was $357,109 of net unrecognized compensation cost related to stock options that have not vested, which is expected to be recognized over a weighted average period of approximately 2.17 years. The total fair value of stock options vested during the six-month periods ended June 30, 2017 and 2016 was $128,125 and $206,701, respectively.

f)
Geographic Information:

U.S. GAAP establishes standards for the manner in which business enterprises report information about operating segments in financial statements and requires that those enterprises report selected information. It also establishes standards for related disclosures about products and services, geographic areas, and major customers.  The table below represents product revenues for different geographic regions.

  
For the three months ended
  
For the six months ended
 
  
June 30, 2017
  
June 30, 2016
  
June 30, 2017
  
June 30, 2016
 
Africa
 
$
493,852
  
$
395,231
  
$
862,679
  
$
713,989
 
Asia
  
92,596
   
88,984
   
1,513,018
   
64,005
 
Europe
  
599,435
   
205,667
   
1,040,160
   
123,096
 
North America
  
672,765
   
667,165
   
1,760,104
   
2,389,024
 
South America
  
1,034,294
   
677,025
   
3,144,353
   
4,660,977
 
  
$
2,892,942
  
$
2,034,072
  
$
8,320,314
  
$
7,951,091
 

g)
Accounts Payable and Accrued Liabilities:

Accounts payable and accrued liabilities consist of:

  
June 30, 2017
  
December 31, 2016
 
Accounts payable – suppliers
 
$
1,823,896
  
$
1,437,290
 
Accrued commissions
  
498,974
   
221,982
 
Accrued royalties / license fees
  
389,705
   
352,660
 
Accrued payroll
  
198,507
   
167,575
 
Accrued vacation
  
312,431
   
289,587
 
Accrued bonuses
  
-
   
282,500
 
Accrued expenses – other
  
477,923
   
261,539
 
TOTAL
 
$
3,701,436
  
$
3,013,133
 

h)     Goodwill and Intangible Assets:

Goodwill represents the excess of the purchase price we paid over the fair value of the net tangible and identifiable intangible assets acquired in our acquisition of RVR in January 2017. Goodwill is not amortized but rather is tested annually for impairment or more frequently if we believe that indicators of impairment exist. Current U.S. generally accepted accounting principles permit us to make a qualitative evaluation about the likelihood of goodwill impairment. If we conclude that it is more likely than not that the fair value of a reporting unit is greater than its carrying amount, then we would not be required to perform the two-step quantitative impairment test. Otherwise, performing the two-step impairment test is necessary. The first step of the two-step quantitative impairment test involves comparing the fair values of the applicable reporting unit with its aggregate carrying value, including goodwill. If the carrying value of a reporting unit exceeds the reporting unit's fair value, we perform the second step of the test to determine the amount of the impairment loss, if any. The second step involves measuring any impairment by comparing the implied fair values of the affected reporting unit's goodwill and intangible assets with the respective carrying values.

If actual future results are not consistent with management's estimates and assumptions, we may have to take an impairment charge in the future related to our goodwill. Future impairment tests will continue to be performed annually in the fiscal first quarter, or sooner if a triggering event occurs. As of June 30, 2017, we believe no indicators of impairment exist.


Goodwill
Beginning balance 1/1/17
 
$
-
    
Acquisition of RVR
  
1,503,361
    
Changes in foreign currency exchange rate
  
67,743
    
Balance at 6/30/17
 
$
1,571,104


In addition, the Company recorded certain intangible assets as part of the RVR acquisition which are as follows as of June 30, 2017.

Cost
  
 Accumulated Amortization 
  
June 30, 2017
Intellectual property
 
$
836,049
  $ 41,802  $          794,247
Customer Contracts/relationships
  
731,543
   36,577    694,966
Order Backlog
  
209,152
   209,152    -
Trade names
  
104,506
  
4,751
    99,755
  
$
1,881,250
  $
(292,282)
  $
1,588,968


Amortization expenses for the six months ended June 30, 2017 was approximately $292,000.

i)
Recent Accounting Pronouncements Affecting the Company:

In May 2014, the FASB issued Accounting Standards Update No. 2014-09, "Revenue from Contracts with Customers" ("ASU 2014-09"), which supersedes nearly all existing revenue recognition guidance under accounting principles generally accepted in the United States ("U.S. GAAP"). The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing U.S. GAAP.

The standard is effective for annual periods beginning after December 15, 2017, and interim periods therein, using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients; or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption (which includes additional footnote disclosures). We are currently evaluating the impact of our pending adoption of ASU 2014-09 on our consolidated financial statements and have not yet determined the method by which we will adopt the standard in 2018.  The Company has conducted a preliminary analysis of its sales contracts which are based on the shipment of goods to the customer, and currently this new accounting standard will not have a material impact on its consolidated financial statements for its sales contracts.  The Company has conducted a preliminary analysis of its current R&D contracts which are currently based on an "as expenses are incurred" basis, and currently this new accounting standard will not have a material impact on its consolidated financial statements for current R&D contracts.

In November 2015, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2015-17, Income Taxes (Topic 740) Balance Sheet Classification of Deferred Assets. This ASU is intended to simplify the presentation of deferred taxes on the balance sheet and will require an entity to present all deferred tax assets and deferred tax liabilities as non-current on the balance sheet. Under the current guidance, entities are required to separately present deferred taxes as current or non-current. Netting deferred tax assets and deferred tax liabilities by tax jurisdiction will still be required under the new guidance. This guidance will be effective for Chembio beginning in 2018, with early adoption permitted. The Company does not believe this new accounting standard update will have a material impact on its consolidated financial statements.

In February 2016, the FASB issued Accounting Standards Update ("ASU") 2016-02, which amends the ASC and creates Topic 842, Leases. Topic 842 will require lessees to recognize lease assets and lease liabilities for those leases classified as operating leases under previous US GAAP on the balance sheet. This guidance is effective for annual periods beginning after December 15, 2018 and early adoption is permitted. We are in the initial stages of evaluating the effect of the standard on our financial statements and will continue to evaluate.  While not yet in a position to assess the full impact of the application of the new standard, the Company expects that the impact of recording the lease liabilities and the corresponding right-to-use assets will have a significant impact on its total assets and liabilities with a minimal impact on equity.

In March 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2016-09, Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, which will change certain aspects of accounting for share-based payments to employees.  ASU 2016-09 is effective for fiscal years (and interim reporting periods within those years) beginning after December 15, 2016.  The Company adopted the provisions of ASU 2016-09 on January 1, 2017.  The Company evaluated this standard and the adoption of it did not have a material impact on its consolidated financial statement.

In January 2017, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2017-04 Intangibles - Goodwill and Other (Topic 350) which would eliminate the requirement to calculate the implied fair value of goodwill to measure a goodwill impairment charge. Instead, the amount of an impairment charge would be recognized if the carrying amount of a reporting unit is greater than its fair value. ASU 2017-04 is effective for public companies for fiscal years beginning after December 15, 2019.  Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017.  The Company is currently evaluating the impact of the provisions of ASU 2017-04.
XML 20 R10.htm IDEA: XBRL DOCUMENT v3.7.0.1
COLLABORATIVE RESEARCH AND DEVELOPMENT AGREEMENTS
 6 Months Ended
Jun. 30, 2017
COLLABORATIVE RESEARCH AND DEVELOPMENT AGREEMENTS [Abstract]  
COLLABORATIVE RESEARCH AND DEVELOPMENT AGREEMENTS
NOTE 4 — COLLABORATIVE RESEARCH AND DEVELOPMENT ARRANGEMENTS:

a)
Brain Injury agreement:

In January 2015, the Company entered into a technology development agreement with Perseus Science Group LLC for $946,000 and a follow-on agreement in December 2016 for $350,000. The Company earned $233,000 and $188,000 for the six-month periods ended June 30, 2017 and 2016, respectively, from this agreement. The Company earned $1,000,000 from this grant from inception through June 30, 2017.

b)
Malaria agreement:

In April 2016, the Company was awarded a grant from the Bill & Melinda Gates Foundation for $678,000.  The Company earned  $159,000 for the six-month period ended June 30, 2017 from this agreement.  The Company earned $678,000 from this grant from inception through June 30, 2017.

c)
Fever Panel agreement:

In October 2015, the Company entered into a technology development agreement with the Paul G. Allen Ebola Program for $2,118,000 and a follow-on agreement in February 2016 for $550,000. The Company earned none and $1,560,000 for the six-month periods ended June 30, 2017 and 2016, respectively, from this agreement. The Company earned $2,668,000 from this grant from inception through June 30, 2017.

d)
BARDA Zika agreement:

In August 2016, the Company was awarded a grant for $5,934,000 from BARDA, which is part of the U.S. Department of Health And Human Resources. The Company earned $880,000 for the six-month period ended June 30, 2017 from this agreement. The Company earned $1,353,000 from this grant from inception through June 30, 2017.

e)
USDA Bovid:

In September 2016, the Company entered into a Phase II agreement with the USDA for an additional $600,000 to develop a Bovid TB assay.  The Phase I agreement was for  $100,000.  Revenue for these agreements are being recognized under a proportional performance method. The Company earned $169,000 for the six-month period ended June 30, 2017 from these agreements. The Company earned $290,000 from these agreements from inception through June 30, 2017.

f)
FIND agreement:

In March 2017, the Company entered into a technology development agreement with FIND  for $999,000. The Company earned $339,000 for the six-month period ended June 30, 2017 from this agreement. The Company earned $339,000 from this grant from inception through June 30, 2017.
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RIGHTS AGREEMENT
 6 Months Ended
Jun. 30, 2017
RIGHTS AGREEMENT [Abstract]  
RIGHTS AGREEMENT
NOTE 5 — RIGHTS AGREEMENT:

In March 2016, the Company entered into a Rights Agreement dated as of March 8, 2016 (the "Rights Agreement") between the Company and Action Stock Transfer Corp., as Rights Agent. Pursuant to the Rights Agreement, the Company declared a dividend of one preferred share purchase right (a "Right") for each outstanding share of common stock, $0.01 par value (the "Common Stock"), of the Company. The Board of Directors set the payment date for the distribution of the Rights as March 8, 2016, and the Rights were distributed to the Company's shareholders of record on that date. The description and terms of the Rights are set forth in the Rights Agreement.

Rights Initially Not Exercisable. The Rights are not exercisable until a Distribution Date, which is defined below. Until a Right is exercised, the holder thereof, in his capacity as a holder of Rights, will have no rights as a shareholder of the Company, including, without limitation, the right to vote or to receive dividends.

Separation and Distribution of Rights. The Rights will be evidenced by the certificates for shares of Common Stock registered in the names of the holders thereof, and not by separate rights certificates until the earlier to occur of (i) the close of business on the tenth business day following a public announcement that an Acquiring Person (as defined in the Rights Agreement) acquired a Combined Ownership (as defined in the Rights Agreement) of 20% or more of the outstanding shares of the Common Stock (the "Shares Acquisition Date") or (ii) the later of (A) the close of business on the tenth business day (or such later date as may be determined by action of the Board of Directors prior to such time as any person or group of affiliated or associated persons becomes an Acquiring Person) after the date that a tender or exchange offer or intention to commence a tender or exchange offer by any person is first published, announced, sent or given within the meaning of Rule 14d-4(A) under the Securities Exchange Act of 1934, as amended, the consummation of which would result in any person having Combined Ownership of 20% or more of the outstanding shares of the Common Stock, or (B) if such a tender or exchange offer has been published, announced, sent or given before the date of the Rights Agreement, then the close of business on the tenth business day after the date the Rights Agreement was entered into (or such later date as may be determined by action of the Board of Directors prior to such time as any person becomes an Acquiring Person); (the earlier of such dates referred to in (i) and (ii), which date may include any such date that is after the date of the Rights Agreement but prior to the issuance of the Rights, being called the "Distribution Date").
XML 22 R12.htm IDEA: XBRL DOCUMENT v3.7.0.1
COMMON STOCK, WARRANTS AND OPTIONS
 6 Months Ended
Jun. 30, 2017
COMMON STOCK, WARRANTS AND OPTIONS [Abstract]  
COMMON STOCK, WARRANTS AND OPTIONS
NOTE 6 — COMMON STOCK, WARRANTS AND OPTIONS:

During the second quarter of 2017, no options were granted or exercised.

During the first quarter of 2017, options to purchase 10,969 shares of the Company's common stock were exercised on a cashless basis into 3,039 shares of common stock at an exercise price of $4.00 by surrendering options and shares of common stock already owned.

The Company completed the acquisition of RVR Diagnostics Sdn Bhd (RVR) on January 9, 2017.  Pursuant to the Stock Purchase Agreement, the Company acquired all of the issued and outstanding common stock and other equity interests of RVR from the sellers for (i) a cash payment of $1,400,000, (ii) contingent consideration of $148,000 and (iii) 269,236 shares of the Company's common stock, of which 7,277 shares are being held back to satisfy certain potential claims under the Stock Purchase Agreement and will become issuable to the Sellers, if at all, on the one-year anniversary of the closing.  The closing price of our common stock on January 9, 2017 was $6.25.

The Company entered into an employment agreement, effective as of March 13, 2017 (the "CEO Employment Agreement"), with John Sperzel to serve as the Company's Chief Executive Officer, for an additional term of three years through March 13, 2020. Pursuant to the Employment Agreement, the Company issued to Mr. Sperzel incentive and non-qualified stock options to purchase 20,000 shares of the Company's common stock. These options vest on the third anniversary or March 31, 2020. The exercise price for these options was equal to the volume weighted trading price for the Company's common stock on March 31, 2017, which was $5.3666 per share. Each option granted will expire and terminate, if not exercised sooner, upon the earlier to occur of (a) 30 days after termination of Mr. Sperzel's employment with the Company or (b) the seventh anniversary of the effective date of the grant.

During the first quarter of 2017, the Company issued options to purchase 5,000 shares of common stock to each of six members of the executive team.  The options became exercisable on the date of issue.  The options issued have an exercise price of $5.25 per share, which was  the last traded price of the common stock on the day issued.  The options expire five years from date of issue.

During the first quarter of 2017, the Company issued options to purchase 36,000 shares of common stock to a newly-hired vice-president of operations. The options are exercisable in three equal annual installments starting on the first anniversary of the date of issue. The options issued have an exercise price of $6.30 per share, which was the last traded price of the common stock on the day issued. The options expire five years from date of issue.

During the year 2016, options to purchase 191,804 shares of the Company's common stock were exercised for cash and on a cashless basis into 125,750 shares of common stock at exercise prices ranging from $2.80 to $5.56 by surrendering options and shares of common stock already owned.

During the fourth quarter of 2016, the Company issued options to purchase 36,000 shares of common stock to a newly-hired president of the EMEA and APAC regions. The options are exercisable in three equal annual installments starting on the first anniversary of the date of issue. The options issued have an exercise price of $7.15 per share, which was the last traded price of the common stock on the day issued. The options expire five years from date of issue.

The Company closed an underwritten public offering of 2,300,000 shares of its common stock on August 3, 2016. The price per share of common stock sold in the offering was $6.00 per share. The net proceeds of the offering, after deducting the underwriters' discounts and other offering expenses payable by the Company, was approximately $12,493,000.  The Company intends to use the net proceeds for business expansion and working capital, including product development, operational improvements, clinical trials, and sales and marketing.

During the second quarter of 2016, the Company issued options to one of its directors pursuant to the Company's compensation policy for directors.  The director was issued options to purchase 46,875 shares of common stock.  The options become exercisable in five equal annual installments starting on the date of issue.  The options issued have an exercise price of $8.86 per share, which was  the last traded price of the common stock on the day issued.  The options expire five years from date of issue.

The Company entered into an employment agreement, effective as of March 5, 2016 (the "Employment Agreement"), with Javan Esfandiari to serve as the Company's Chief Scientific and Technical Officer, for an additional term of three years through March 5, 2019. Pursuant to the Employment Agreement, the Company issued to Mr. Esfandiari incentive and non-qualified stock options to purchase 60,000 shares of the Company's common stock. Of these stock options, options to purchase 20,000 shares vest on each of the first three anniversaries of March 11, 2016 which is the date on which the Employment Agreement was entered into. The exercise price for these options is equal to the trading price for the Company's common stock on March 11, 2016, which was $5.64 per share. Each option granted will expire and terminate, if not exercised sooner, upon the earlier to occur of (a) 30 days after termination of Mr. Esfandiari's employment with the Company or (b) the fifth anniversary of the effective date of the grant.
XML 23 R13.htm IDEA: XBRL DOCUMENT v3.7.0.1
COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS
 6 Months Ended
Jun. 30, 2017
COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS  
COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS
NOTE 7 — COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS:

a)
Economic Dependency:

The following table discloses product sales and accounts receivable the Company had with respect to each customer that purchased in excess of 10% of the Company's net product sales for the periods indicated:

 
For the three months ended
 
For the six months ended
 
Accounts Receivable as of
 
June 30, 2017
 
June 30, 2016
 
June 30, 2017
 
June 30, 2016
 
June 30, 2017
 
June 30, 2016
 
Sales
 
% of Sales
 
Sales
 
% of Sales
 
Sales
 
% of Sales
 
Sales
 
% of Sales
    
Customer 1
 
$
956,207
 
33
%
 
$
666,765
 
33
%
 
$
2,895,794
 
35
%
 
$
3,256,170
 
41
%
 
$
2,729,804
  
$
3,389,505
Customer 2
  
*
 
*
   
*
 
*
   
*
 
*
   
1,796,477
 
23
%
  
*
   
-
Customer 3
  
*
 
*
   
*
 
*
   
1,326,171
 
16
%
  
*
 
*
   
-
   
*
Customer 4
  
399,482
 
14
%
  
*
 
*
   
754,408
 
9
%
  
*
 
*
   
-
   
*

(*) Product sales did not exceed 10% for the period indicated.

Note that sales include product sales only while accounts receivable reflects the total due from the customer, which includes freight.

The following table discloses purchases and accounts payable that the Company had with respect to each vendor that sold to the  Company in excess of 10% of the Company's total purchases for the periods indicated:

 
For the three months ended
 
For the six months ended
 
Accounts Payable as of
 
June 30, 2017
 
June 30, 2016
 
June 30, 2017
 
June 30, 2016
 
June 30, 2017
 
June 30, 2016
 
Purchases
 
% of Purc.
 
Purchases
 
% of Purc.
 
Purchases
 
% of Purc.
 
Purchases
 
% of Purc.
    
Vendor 1
 
$
*
 
*
  
$
203,020
 
12
%
 
$
*
 
*
  
$
425,922
 
13
%
 
$
*
  
$
60,935
Vendor 2
  
698,838
 
32
%
  
*
 
*
   
698,838
 
26
%
  
*
 
*
   
-
   
*
Vendor 3
  
204,781
 
11
%
  
*
 
*
   
*
 
*
   
*
 
*
   
29,613
   
*

(*) Purchases did not exceed 10% for the period indicated

The Company currently buys materials which are purchased under intellectual property rights agreements and are important components in its products. Management believes that other suppliers could provide similar materials on comparable terms as the vendors shown in this table. A change in suppliers, however, could cause a delay in manufacturing, either from the logistics of changing suppliers or from product changes attributable to new components, which could result in a possible loss of sales, and which could adversely affect operating results.

b)
Governmental Regulation:

All of the Company's existing and proposed diagnostic products are regulated by the United States Food and Drug Administration, United States Department of Agriculture, certain U.S., state and local agencies, and/or comparable regulatory bodies in other countries. Most aspects of development, production, and marketing, including product testing, authorizations to market, labeling, promotion, manufacturing, and record keeping, are subject to regulatory review. After marketing approval has been granted, Chembio must continue to comply with governmental regulations. Failure to comply with these regulations can result in significant penalties.

c)
Employment Agreements:

The Company has employment contracts with four key employees: CEO John J. Sperzel III; CSTO Javan Esfandiari; Managing Director of RVR Magentiren Vajuram; Vice-President of RVR Dr. Avijit Roy. The contracts call for salaries presently aggregating $1,000,000 per year. The Sperzel contract expires in March 2020, the Esfandiari contract expires in March 2019, and the Vajuram and Roy contracts expire January 9, 2018. In connection with the Sperzel contract that expires in March 2020, the Company issued, in March 2017, options to purchase 20,000 common shares of stock, which vest on the third anniversary of the grant. In connection with the Esfandiari contract that expires in March 2019, the Company issued, in March 2016, options to purchase 60,000 shares of common stock, with one-third vesting on each of the first, second and third anniversaries of the grant.
XML 24 R14.htm IDEA: XBRL DOCUMENT v3.7.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
 6 Months Ended
Jun. 30, 2017
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
Basis of Presentation
NOTE 3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:

a)
Basis of Presentation:

The preceding (a) condensed consolidated balance sheet as of December 31, 2016, which has been derived from audited financial statements, and (b) the unaudited interim condensed consolidated financial statements as of June 30, 2017 and for the three and six-month periods ended June 30, 2017 and 2016, respectively, have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the "SEC"). Certain information and footnote disclosures, which are normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America, have been condensed or omitted pursuant to such rules and regulations, although we believe that the disclosures made are adequate to provide for fair presentation. The interim financial information should be read in conjunction with the Financial Statements and the notes thereto, included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2016, previously filed with the SEC.

In the opinion of management, all adjustments (which include normal recurring adjustments) necessary to present a fair statement of the Company's condensed consolidated financial position as of June 30, 2017, its condensed consolidated results of operations for the three and six-month periods ended June 30, 2017 and 2016, respectively, and its condensed consolidated cash flows for the six-month periods ended June 30, 2017 and 2016, as applicable, have been made. The interim results of operations are not necessarily indicative of the operating results for the full fiscal year or any future periods.
Revenue Recognition
b)
Revenue Recognition:

The Company recognizes revenue for product sales in accordance with ASC 605, which provides that revenue is recognized when there is persuasive evidence of an arrangement, delivery has occurred or services have been rendered, the sales price is determinable, and collectability is reasonably assured. Revenue typically is recognized at time of shipment. Sales are recorded net of discounts, rebates and returns.

For certain contracts, the Company recognizes revenue from non-milestone payments and grant revenues when earned. Grants are invoiced after expenses are incurred. Revenues from projects or grants funded in advance are deferred until earned. Deferred revenues not earned were $161,356 and $392,517 as of June 30, 2017 and December 31, 2016, respectively.

The Company follows Financial Accounting Standards Board ("FASB") authoritative guidance ("guidance") prospectively for the recognition of revenue under the milestone method. The Company applies the milestone method of revenue recognition for certain collaborative research projects defining milestones at the inception of the agreement.
Inventories
c)
Inventories:


Inventories consist of the following at:

  
June 30, 2017
  
December 31, 2016
 
Raw materials
 
$
2,134,288
  
$
1,824,248
 
Work in process
  
532,417
   
535,320
 
Finished goods
  
2,327,246
   
975,620
 
  
$
4,993,951
  
$
3,335,188
 

Inventories are stated net of reserves of approximately $245,000 as of June 30, 2017 and December 31, 2016.
Earnings Per Share
d)
Earnings Per Share:

Basic earnings per share is computed by dividing net income or loss by the weighted-average number of common shares outstanding for the period. Diluted income per share reflects the potential dilution from the exercise or conversion of other securities into common stock, but only if dilutive. The following securities, presented on a common share equivalent basis for the three- and six-month periods ended June 30, 2017 and 2016, have been included in the earnings per share computations:

 
For the three months ended
 
For the six months ended
 
June 30, 2017
 
June 30, 2016
 
June 30, 2017
 
June 30, 2016
Basic
 
12,299,122
  
9,667,543
  
12,284,979
  
9,649,612
            
Diluted
 
12,299,122
  
9,667,543
  
12,284,979
  
9,649,612

As there were losses for the three and six months ended June 30, 2017 and 2016, no common share equivalents are included in the diluted per share computations.

There were 674,795 and 667,995 weighted-average number of options outstanding as of June 30, 2017 and 2016, respectively, that were not included in the calculation of diluted per common share equivalent for the three months ended June 30, 2017 and 2016 respectively, because the effect would have been anti-dilutive. There were 674,795 and 708,514 weighted-average number of options outstanding as of June 30, 2017 and 2016, respectively, that were not included in the calculation of diluted per common share equivalent for the six months ended June 30, 2017 and 2016, respectively, because the effect would have been anti-dilutive.
Employee Stock Option Plan
e)
Employee Stock Option Plans and Share-Based Compensation:

Effective June 3, 2008, the Company's stockholders voted to approve the 2008 Stock Incentive Plan ("SIP"), initially with 625,000 shares of Common Stock available to be issued. At the Annual Stockholder meeting on September 22, 2011, the Company's stockholders voted to approve an increase to the shares of Common Stock issuable under the SIP by 125,000 to 750,000. Under the terms of the SIP, the Compensation Committee of the Company's Board has the discretion to select the persons to whom awards are to be granted and the number of shares of common stock to be covered by each grant. Awards can be incentive stock options, restricted stock and/or restricted stock units. The awards become vested at such times and under such conditions as determined by the Compensation Committee at the time of the initial stock option grant. As of June 30, 2017, there were 470,724 options exercised and 264,177 options outstanding under the SIP.

Effective June 19, 2014, the Company's stockholders voted to approve the 2014 Stock Incentive Plan ("2014-SIP"), with 800,000 shares of Common Stock available to be issued. Under the terms of the 2014-SIP, the Compensation Committee of the Company's Board has the discretion to select the persons to whom awards are to be granted and the number of shares of common stock to be covered by each grant. Awards can be incentive stock options, restricted stock and/or restricted stock units. The awards become vested at such times and under such conditions as determined by the Compensation Committee at the time of the initial stock option grant. As of June 30, 2017, there were 12,000 options exercised, 203,750 options outstanding and 584,250 options or shares still available to be issued under the 2014-SIP.

There were 86,000 and 106,875 stock options granted during the six months ended June 30, 2017 and 2016, respectively.  The weighted average estimated fair value, at their respective dates of grant, of stock options granted in the six months ended June 30, 2017 and June 30, 2016, was $2.27 and $2.77 per share, respectively.  The fair value of options at the date of grant was estimated using the Black-Scholes option pricing model. The expected volatility is based upon the historical volatility of our stock. The expected term is based on historical information.


The assumptions made in calculating the fair values of options granted during the periods indicated are as follows:

 
For the three months ended
 
For the six months ended
 
June 30, 2017
 
June 30, 2016
 
June 30, 2017
 
June 30, 2016
Expected term (in years)
n/a
 
4.5
 
5.0
 
4.5 to 5.0
Expected volatility
n/a
 
43.00%
 
44.18%
 
43.00% to 48.66%
Expected dividend yield
n/a
 
0%
 
0%
 
0%
Risk-free interest rate
n/a
 
0.90%
 
1.58%
 
0.90% to 0.97%


The Company's results for the three-month periods ended June 30, 2017 and 2016 include share-based compensation expense, consisting solely of stock options, totaling $73,700 and $92,700, respectively. Such amounts have been included in the Condensed Consolidated Statements of Operations within cost of product sales ($12,800 and none), research and development ($12,100 and $27,300, respectively) and selling, general and administrative expenses ($48,800 and $65,400, respectively). The results for the six-month periods ended June 30, 2017 and 2016 include share-based compensation expense, consisting solely of stock options, totaling approximately $209,600 and $146,200, respectively. Such amounts have been included in the Condensed Consolidated Statements of Operations within cost of product sales ($21,400 and none), research and development ($65,200 and $34,700, respectively) and selling, general and administrative expenses ($123,000 and $111,500, respectively). An operating expense, resulting in income tax benefit, has been recognized in the statement of operations for share-based compensation arrangements.

Stock option compensation expense for the three and six months ended June 30, 2017 and 2016 is based on the estimated fair value, at the date of issuance, of options outstanding, which is being amortized on a straight-line basis over the requisite service period for each vesting portion of the award. Accordingly, for stock options that vested immediately, the estimated fair value was expensed immediately.

The following table provides stock option activity for the six months ended June 30, 2017:

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
      
Forfeited/expired/cancelled
  
785
   
5.56
      
Outstanding at June 30, 2017
  
674,795
  
$
4.70
 
3.28 years
 
$
1,089,594
 
              
Exercisable at June 30, 2017
  
383,920
  
$
4.29
 
2.76 years
 
$
727,568
 

As of June 30, 2017, there was $357,109 of net unrecognized compensation cost related to stock options that have not vested, which is expected to be recognized over a weighted average period of approximately 2.17 years. The total fair value of stock options vested during the six-month periods ended June 30, 2017 and 2016 was $128,125 and $206,701, respectively.
Geographic Information
f)
Geographic Information:

U.S. GAAP establishes standards for the manner in which business enterprises report information about operating segments in financial statements and requires that those enterprises report selected information. It also establishes standards for related disclosures about products and services, geographic areas, and major customers.  The table below represents product revenues for different geographic regions.

  
For the three months ended
  
For the six months ended
 
  
June 30, 2017
  
June 30, 2016
  
June 30, 2017
  
June 30, 2016
 
Africa
 
$
493,852
  
$
395,231
  
$
862,679
  
$
713,989
 
Asia
  
92,596
   
88,984
   
1,513,018
   
64,005
 
Europe
  
599,435
   
205,667
   
1,040,160
   
123,096
 
North America
  
672,765
   
667,165
   
1,760,104
   
2,389,024
 
South America
  
1,034,294
   
677,025
   
3,144,353
   
4,660,977
 
  
$
2,892,942
  
$
2,034,072
  
$
8,320,314
  
$
7,951,091
 
Accounts Payable and Accrued Liabilities
g)
Accounts Payable and Accrued Liabilities:

Accounts payable and accrued liabilities consist of:

  
June 30, 2017
  
December 31, 2016
 
Accounts payable – suppliers
 
$
1,823,896
  
$
1,437,290
 
Accrued commissions
  
498,974
   
221,982
 
Accrued royalties / license fees
  
389,705
   
352,660
 
Accrued payroll
  
198,507
   
167,575
 
Accrued vacation
  
312,431
   
289,587
 
Accrued bonuses
  
-
   
282,500
 
Accrued expenses – other
  
477,923
   
261,539
 
TOTAL
 
$
3,701,436
  
$
3,013,133
 
Goodwill and Intangible Assets, Policy [Policy Text Block]
h)     Goodwill and Intangible Assets:

Goodwill represents the excess of the purchase price we paid over the fair value of the net tangible and identifiable intangible assets acquired in our acquisition of RVR in January 2017. Goodwill is not amortized but rather is tested annually for impairment or more frequently if we believe that indicators of impairment exist. Current U.S. generally accepted accounting principles permit us to make a qualitative evaluation about the likelihood of goodwill impairment. If we conclude that it is more likely than not that the fair value of a reporting unit is greater than its carrying amount, then we would not be required to perform the two-step quantitative impairment test. Otherwise, performing the two-step impairment test is necessary. The first step of the two-step quantitative impairment test involves comparing the fair values of the applicable reporting unit with its aggregate carrying value, including goodwill. If the carrying value of a reporting unit exceeds the reporting unit's fair value, we perform the second step of the test to determine the amount of the impairment loss, if any. The second step involves measuring any impairment by comparing the implied fair values of the affected reporting unit's goodwill and intangible assets with the respective carrying values.

If actual future results are not consistent with management's estimates and assumptions, we may have to take an impairment charge in the future related to our goodwill. Future impairment tests will continue to be performed annually in the fiscal first quarter, or sooner if a triggering event occurs. As of June 30, 2017, we believe no indicators of impairment exist.


Goodwill
Beginning balance 1/1/17
 
$
-
    
Acquisition of RVR
  
1,503,361
    
Changes in foreign currency exchange rate
  
67,743
    
Balance at 6/30/17
 
$
1,571,104


In addition, the Company recorded certain intangible assets as part of the RVR acquisition which are as follows as of June 30, 2017.

Cost
  
 Accumulated Amortization 
  
June 30, 2017
Intellectual property
 
$
836,049
  $ 41,802  $          794,247
Customer Contracts/relationships
  
731,543
   36,577    694,966
Order Backlog
  
209,152
   209,152    -
Trade names
  
104,506
  
4,751
    99,755
  
$
1,881,250
  $
(292,282)
  $
1,588,968


Amortization expenses for the six months ended June 30, 2017 was approximately $292,000.
Recent Accounting Pronouncements Affecting the Company
i)
Recent Accounting Pronouncements Affecting the Company:

In May 2014, the FASB issued Accounting Standards Update No. 2014-09, "Revenue from Contracts with Customers" ("ASU 2014-09"), which supersedes nearly all existing revenue recognition guidance under accounting principles generally accepted in the United States ("U.S. GAAP"). The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing U.S. GAAP.

The standard is effective for annual periods beginning after December 15, 2017, and interim periods therein, using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients; or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption (which includes additional footnote disclosures). We are currently evaluating the impact of our pending adoption of ASU 2014-09 on our consolidated financial statements and have not yet determined the method by which we will adopt the standard in 2018.  The Company has conducted a preliminary analysis of its sales contracts which are based on the shipment of goods to the customer, and currently this new accounting standard will not have a material impact on its consolidated financial statements for its sales contracts.  The Company has conducted a preliminary analysis of its current R&D contracts which are currently based on an "as expenses are incurred" basis, and currently this new accounting standard will not have a material impact on its consolidated financial statements for current R&D contracts.

In November 2015, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2015-17, Income Taxes (Topic 740) Balance Sheet Classification of Deferred Assets. This ASU is intended to simplify the presentation of deferred taxes on the balance sheet and will require an entity to present all deferred tax assets and deferred tax liabilities as non-current on the balance sheet. Under the current guidance, entities are required to separately present deferred taxes as current or non-current. Netting deferred tax assets and deferred tax liabilities by tax jurisdiction will still be required under the new guidance. This guidance will be effective for Chembio beginning in 2018, with early adoption permitted. The Company does not believe this new accounting standard update will have a material impact on its consolidated financial statements.

In February 2016, the FASB issued Accounting Standards Update ("ASU") 2016-02, which amends the ASC and creates Topic 842, Leases. Topic 842 will require lessees to recognize lease assets and lease liabilities for those leases classified as operating leases under previous US GAAP on the balance sheet. This guidance is effective for annual periods beginning after December 15, 2018 and early adoption is permitted. We are in the initial stages of evaluating the effect of the standard on our financial statements and will continue to evaluate.  While not yet in a position to assess the full impact of the application of the new standard, the Company expects that the impact of recording the lease liabilities and the corresponding right-to-use assets will have a significant impact on its total assets and liabilities with a minimal impact on equity.

In March 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2016-09, Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, which will change certain aspects of accounting for share-based payments to employees.  ASU 2016-09 is effective for fiscal years (and interim reporting periods within those years) beginning after December 15, 2016.  The Company adopted the provisions of ASU 2016-09 on January 1, 2017.  The Company evaluated this standard and the adoption of it did not have a material impact on its consolidated financial statement.

In January 2017, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2017-04 Intangibles - Goodwill and Other (Topic 350) which would eliminate the requirement to calculate the implied fair value of goodwill to measure a goodwill impairment charge. Instead, the amount of an impairment charge would be recognized if the carrying amount of a reporting unit is greater than its fair value. ASU 2017-04 is effective for public companies for fiscal years beginning after December 15, 2019.  Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017.  The Company is currently evaluating the impact of the provisions of ASU 2017-04.
XML 25 R15.htm IDEA: XBRL DOCUMENT v3.7.0.1
ACQUISITION OF RVR DIAGNOSTICS SDN BHD (Tables)
 6 Months Ended
Jun. 30, 2017
ACQUISITION OF RVR DIAGNOSTICS SDN BHD [Abstract]  
Fair values of assets acquired and liabilities assumed
The acquisition was accounted for using the purchase method of accounting.  The following table summarizes the preliminary allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed on the closing date of January 9, 2017:

 
 
PRELIMINARY
 
    
Property, plant and equipment
 
$
235,141
 
Goodwill
  
1,503,361
 
Deferred tax liability
  
(307,636
)
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
 

* Total consideration includes the $1,400,000 paid in cash, $1,683,000 in shares of common stock and $148,000 in contingent consideration.
Unaudited pro forma operating results
For the period from January 10, 2017 to June 30, 2017, net sales and loss before income taxes from the acquisition was approximately $1,423,000 and $(150,000), respectively, which have been included in the Condensed Consolidated Statement of Operations for the six months ended June 30, 2017.  The following represents unaudited pro forma operating results as if the operations of RVR had been included in the Company's Condensed Consolidated Statements of Operations as of January 1, 2016:

Proforma table
 
For the six months ended June 30, 2016
 
Total revenues
 
$
10,158,295
 
     
Net loss
 
$
(8,643,841
)
     
Net loss per common share
 
$
(.90
)
     
Diluted net loss per common share
 
$
(.90
)
XML 26 R16.htm IDEA: XBRL DOCUMENT v3.7.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
 6 Months Ended
Jun. 30, 2017
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
Schedule of inventories
Inventories consist of the following at:

  
June 30, 2017
  
December 31, 2016
 
Raw materials
 
$
2,134,288
  
$
1,824,248
 
Work in process
  
532,417
   
535,320
 
Finished goods
  
2,327,246
   
975,620
 
  
$
4,993,951
  
$
3,335,188
 

Inventories are stated net of reserves of approximately $245,000 as of June 30, 2017 and December 31, 2016.
Schedule of weighted average shares used for computation of basic and diluted earnings per share
Basic earnings per share is computed by dividing net income or loss by the weighted-average number of common shares outstanding for the period. Diluted income per share reflects the potential dilution from the exercise or conversion of other securities into common stock, but only if dilutive. The following securities, presented on a common share equivalent basis for the three- and six-month periods ended June 30, 2017 and 2016, have been included in the earnings per share computations:

 
For the three months ended
 
For the six months ended
 
June 30, 2017
 
June 30, 2016
 
June 30, 2017
 
June 30, 2016
Basic
 
12,299,122
  
9,667,543
  
12,284,979
  
9,649,612
            
Diluted
 
12,299,122
  
9,667,543
  
12,284,979
  
9,649,612
Assumptions made in calculating fair values of options
The assumptions made in calculating the fair values of options granted during the periods indicated are as follows:

 
For the three months ended
 
For the six months ended
 
June 30, 2017
 
June 30, 2016
 
June 30, 2017
 
June 30, 2016
Expected term (in years)
n/a
 
4.5
 
5.0
 
4.5 to 5.0
Expected volatility
n/a
 
43.00%
 
44.18%
 
43.00% to 48.66%
Expected dividend yield
n/a
 
0%
 
0%
 
0%
Risk-free interest rate
n/a
 
0.90%
 
1.58%
 
0.90% to 0.97%
Stock option activity
The following table provides stock option activity for the six months ended June 30, 2017:

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
      
Forfeited/expired/cancelled
  
785
   
5.56
      
Outstanding at June 30, 2017
  
674,795
  
$
4.70
 
3.28 years
 
$
1,089,594
 
              
Exercisable at June 30, 2017
  
383,920
  
$
4.29
 
2.76 years
 
$
727,568
 
Net product sales by geographic area
  
For the three months ended
  
For the six months ended
 
  
June 30, 2017
  
June 30, 2016
  
June 30, 2017
  
June 30, 2016
 
Africa
 
$
493,852
  
$
395,231
  
$
862,679
  
$
713,989
 
Asia
  
92,596
   
88,984
   
1,513,018
   
64,005
 
Europe
  
599,435
   
205,667
   
1,040,160
   
123,096
 
North America
  
672,765
   
667,165
   
1,760,104
   
2,389,024
 
South America
  
1,034,294
   
677,025
   
3,144,353
   
4,660,977
 
  
$
2,892,942
  
$
2,034,072
  
$
8,320,314
  
$
7,951,091
 
Schedule of accounts payable and accrued liabilities
Accounts payable and accrued liabilities consist of:

  
June 30, 2017
  
December 31, 2016
 
Accounts payable – suppliers
 
$
1,823,896
  
$
1,437,290
 
Accrued commissions
  
498,974
   
221,982
 
Accrued royalties / license fees
  
389,705
   
352,660
 
Accrued payroll
  
198,507
   
167,575
 
Accrued vacation
  
312,431
   
289,587
 
Accrued bonuses
  
-
   
282,500
 
Accrued expenses – other
  
477,923
   
261,539
 
TOTAL
 
$
3,701,436
  
$
3,013,133
 
XML 27 R17.htm IDEA: XBRL DOCUMENT v3.7.0.1
COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS (Tables)
 6 Months Ended
Jun. 30, 2017
COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS  
Customer and purchase concentration risks
The following table discloses product sales and accounts receivable the Company had with respect to each customer that purchased in excess of 10% of the Company's net product sales for the periods indicated:

 
For the three months ended
 
For the six months ended
 
Accounts Receivable as of
 
June 30, 2017
 
June 30, 2016
 
June 30, 2017
 
June 30, 2016
 
June 30, 2017
 
June 30, 2016
 
Sales
 
% of Sales
 
Sales
 
% of Sales
 
Sales
 
% of Sales
 
Sales
 
% of Sales
    
Customer 1
 
$
956,207
 
33
%
 
$
666,765
 
33
%
 
$
2,895,794
 
35
%
 
$
3,256,170
 
41
%
 
$
2,729,804
  
$
3,389,505
Customer 2
  
*
 
*
   
*
 
*
   
*
 
*
   
1,796,477
 
23
%
  
*
   
-
Customer 3
  
*
 
*
   
*
 
*
   
1,326,171
 
16
%
  
*
 
*
   
-
   
*
Customer 4
  
399,482
 
14
%
  
*
 
*
   
754,408
 
9
%
  
*
 
*
   
-
   
*

(*) Product sales did not exceed 10% for the period indicated.

Note that sales include product sales only while accounts receivable reflects the total due from the customer, which includes freight.

The following table discloses purchases and accounts payable that the Company had with respect to each vendor that sold to the  Company in excess of 10% of the Company's total purchases for the periods indicated:

 
For the three months ended
 
For the six months ended
 
Accounts Payable as of
 
June 30, 2017
 
June 30, 2016
 
June 30, 2017
 
June 30, 2016
 
June 30, 2017
 
June 30, 2016
 
Purchases
 
% of Purc.
 
Purchases
 
% of Purc.
 
Purchases
 
% of Purc.
 
Purchases
 
% of Purc.
    
Vendor 1
 
$
*
 
*
  
$
203,020
 
12
%
 
$
*
 
*
  
$
425,922
 
13
%
 
$
*
  
$
60,935
Vendor 2
  
698,838
 
32
%
  
*
 
*
   
698,838
 
26
%
  
*
 
*
   
-
   
*
Vendor 3
  
204,781
 
11
%
  
*
 
*
   
*
 
*
   
*
 
*
   
29,613
   
*

(*) Purchases did not exceed 10% for the period indicated
XML 28 R18.htm IDEA: XBRL DOCUMENT v3.7.0.1
DESCRIPTION OF BUSINESS (Details) - Net Product Revenue [Member]
 6 Months Ended
Jun. 30, 2017
Lateral Flow Rapid HIV Tests [Member]  
Product Information [Line Items]  
Concentration risk percentage 39.00%
Patented DPP Platform [Member]  
Product Information [Line Items]  
Concentration risk percentage 41.00%
Other Rapid Tests [Member]  
Product Information [Line Items]  
Concentration risk percentage 20.00%
XML 29 R19.htm IDEA: XBRL DOCUMENT v3.7.0.1
ACQUISITION OF RVR DIAGNOSTICS SDN BHD (Details) - USD ($)
 3 Months Ended 6 Months Ended
Jan. 09, 2017
Jun. 30, 2017
Mar. 31, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2017
Jun. 30, 2016
Dec. 31, 2016
Fair values of Assets Acquired and Liabilities Assumed [Abstract]                
Goodwill $ 1,503,361 $ 1,571,104     $ 1,571,104 $ 1,571,104   $ 0
Deferred Income Taxes and Other Tax Liabilities, Noncurrent (307,636)              
Other intangible assets (estimated useful life):                
Other Comprehensive Income (Loss), Foreign Currency Transaction and Translation Gain (Loss), before Reclassification and Tax   67,743            
Finite-Lived Intangible Assets, Gross   1,881,250     1,881,250 1,881,250    
Finite-Lived Intangible Assets, Accumulated Amortization   292,282     292,282 292,282    
Finite-Lived Intangible Assets, Net, Total   1,588,968     1,588,968 1,588,968   $ 0
Net sales   4,114,814   $ 3,266,405   10,439,980 $ 9,867,504  
Income before income taxes   (2,173,093)   $ (2,384,664)   (3,788,667) (2,850,254)  
Intellectual Property [Member]                
Other intangible assets (estimated useful life):                
Finite-Lived Intangible Assets, Gross   836,049     836,049 836,049    
Finite-Lived Intangible Assets, Accumulated Amortization   41,802     41,802 41,802    
Finite-Lived Intangible Assets, Net, Total   794,247     794,247 794,247    
Customer Contracts / Relationships [Member]                
Other intangible assets (estimated useful life):                
Finite-Lived Intangible Assets, Gross   731,543     731,543 731,543    
Finite-Lived Intangible Assets, Accumulated Amortization   36,577     36,577 36,577    
Finite-Lived Intangible Assets, Net, Total   694,966     694,966 694,966    
Order Backlog [Member]                
Other intangible assets (estimated useful life):                
Finite-Lived Intangible Assets, Gross   209,152     209,152 209,152    
Finite-Lived Intangible Assets, Accumulated Amortization   209,152     209,152 209,152    
Finite-Lived Intangible Assets, Net, Total   0     0 0    
Trade Names [Member]                
Other intangible assets (estimated useful life):                
Finite-Lived Intangible Assets, Gross   104,506     104,506 104,506    
Finite-Lived Intangible Assets, Accumulated Amortization   4,751     4,751 4,751    
Finite-Lived Intangible Assets, Net, Total   99,755     99,755 99,755    
RVR Diagnostics Sdn Bhd [Member]                
Business Acquisition [Line Items]                
Deposit for investments $ 550,000              
Shares issued (in shares) 269,236              
Shares issued , value $ 1,683,000              
Shares held back (in shares) 7,277              
Maximum overage $ 250,000              
Actual sales achieved 250,000              
Amount accrued     $ 148,000          
Estimated value of common stock     $ 85,000          
Percentage of milestone payments     74.50%          
Discounted percentage     15.00%          
Cash portion of milestone payment     $ 63,000          
Business acquisition transaction costs   $ 25,000     25,000 25,000    
Fair values of Assets Acquired and Liabilities Assumed [Abstract]                
Property, plant and equipment 235,141              
Goodwill 1,503,361              
Other intangible assets (estimated useful life):                
Other intangible assets 1,800,000              
Total consideration [1] 3,231,000              
Cash payment 1,400,000              
Consideration in common stock value 1,683,000              
Contingent consideration 148,000              
Net sales         1,423,000      
Income before income taxes         (150,000)      
Unaudited Pro Forma Operating Results [Abstract]                
Total Revenue             10,158,295  
Net loss             $ (8,643,841)  
Net loss per common share             $ (0.90)  
Diluted net loss per common share             $ (0.90)  
Amortization of Intangible Assets         $ 292,000 $ 292,000    
RVR Diagnostics Sdn Bhd [Member] | Intellectual Property [Member]                
Other intangible assets (estimated useful life):                
Other intangible assets 800,000              
Weighted average useful life           10 years    
RVR Diagnostics Sdn Bhd [Member] | Customer Contracts / Relationships [Member]                
Other intangible assets (estimated useful life):                
Other intangible assets 700,000              
Weighted average useful life           10 years    
RVR Diagnostics Sdn Bhd [Member] | Order Backlog [Member]                
Other intangible assets (estimated useful life):                
Other intangible assets 200,134              
Weighted average useful life           3 months    
RVR Diagnostics Sdn Bhd [Member] | Trade Names [Member]                
Other intangible assets (estimated useful life):                
Other intangible assets 100,000              
Weighted average useful life           11 years    
RVR Diagnostics Sdn Bhd [Member] | Minimum [Member]                
Business Acquisition [Line Items]                
Actual sales to determine Milestone Proration Amount 2,250,000              
RVR Diagnostics Sdn Bhd [Member] | Maximum [Member]                
Business Acquisition [Line Items]                
Cash milestone payment $ 100,000              
Stock milestone payment (in shares) 21,830              
[1] Total consideration includes the $1,400,000 paid in cash, the $1,683,000 in common stock value and $148,000 in contingent consideration.
XML 30 R20.htm IDEA: XBRL DOCUMENT v3.7.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($)
 3 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2017
Mar. 31, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2017
Jun. 30, 2016
Dec. 31, 2016
Jun. 30, 2017
Jan. 09, 2017
Dec. 31, 2016
Dec. 31, 2008
Revenue Recognition [Abstract]                      
Deferred revenue               $ 161,356   $ 392,517  
Inventories [Abstract]                      
Raw materials               2,134,288   1,824,248  
Work in process               532,417   535,320  
Finished goods               2,327,246   975,620  
Inventories               4,993,951   3,335,188  
Inventory valuation reserves     $ 245,000     $ 245,000       245,000  
Summary of weighted average shares used for computation of basic and diluted earnings per share [Abstract]                      
Basic (in shares) 12,299,122   9,667,543   12,284,979 9,649,612          
Diluted (in shares) 12,299,122   9,667,543   12,284,979 9,649,612          
Summary of common share equivalent basis, used in diluted per share computations [Abstract]                      
Additional stock options (in shares) 0   0   0 0          
Options and warrants excluded from calculation of diluted per common share equivalent because the effect would have been anti-dilutive (in shares) 674,795   667,995   674,795 708,514          
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                      
Number of stock options exercised under the plan (in shares)   10,969         191,804        
Weighted average estimated grant-date fair value of stock options granted (in dollars per share)         $ 2.27 $ 2.77          
Stock options, number of shares [Roll forward]                      
Exercised (in shares)   10,969         191,804        
Stock options, outstanding, weighted average exercise price per share [Roll Forward]                      
Exercised (in dollars per share)   $ 4.00                  
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]                      
Allocated share-based compensation expense $ 73,700   $ 92,700   $ 209,600 $ 146,200          
Revenues from External Customers [Line Items]                      
Net product sales $ 2,892,942   $ 2,034,072   $ 8,320,314 $ 7,951,091          
Summary of accounts payable and accrued liabilities [Abstract]                      
Accounts payable - suppliers               1,823,896   1,437,290  
Accrued commissions               498,974   221,982  
Accrued royalties / license fees               389,705   352,660  
Accrued payroll               198,507   167,575  
Accrued vacation               312,431   289,587  
Accrued bonuses               0   282,500  
Accrued expenses - other               477,923   261,539  
TOTAL               $ 3,701,436   $ 3,013,133  
Minimum [Member]                      
Stock options, outstanding, weighted average exercise price per share [Roll Forward]                      
Exercised (in dollars per share)             $ 2.80        
Maximum [Member]                      
Stock options, outstanding, weighted average exercise price per share [Roll Forward]                      
Exercised (in dollars per share)             $ 5.56        
Stock Options [Member]                      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                      
Number of stock options outstanding under the plan (in shares) 674,795 600,549   674,795 600,549   600,549 674,795   600,549  
Number of stock options exercised under the plan (in shares)         10,969            
Assumptions made in calculating fair values of options [Abstract]                      
Expected term     4 years 6 months   5 years            
Expected volatility     43.00%   44.18%            
Expected dividend yield     0.00%   0.00% 0.00%          
Risk-free interest rate     0.90%   1.58%            
Stock options, number of shares [Roll forward]                      
Outstanding, beginning of period (in shares)   600,549     600,549            
Granted (in shares)         86,000   106,875        
Exercised (in shares)         10,969            
Forfeited/expired/cancelled (in shares)         785            
Outstanding, end of period (in shares) 674,795     674,795 674,795   600,549        
Exercisable, end of period (in shares) 383,920     383,920 383,920            
Stock options, outstanding, weighted average exercise price per share [Roll Forward]                      
Outstanding, beginning of period (in dollars per share)   $ 4.55     $ 4.55            
Granted (in dollars per share)         5.72            
Exercised (in dollars per share)         4.00            
Forfeited/expired/cancelled (in dollars per share)         5.56            
Outstanding, end of period (in dollars per share) $ 4.70     $ 4.70 4.70   $ 4.55        
Exercisable, end of period (in dollars per share) $ 4.29     $ 4.29 $ 4.29            
Stock options, additional disclosure [Abstract]                      
Outstanding, weighted average remaining contractual term         3 years 3 months 11 days   3 years 5 months 5 days        
Exercisable, weighted average remaining contractual term         2 years 9 months 4 days            
Outstanding, aggregate intrinsic value, beginning of period   $ 1,463,052     $ 1,463,052            
Exercised, aggregate intrinsic value         34,152            
Outstanding, aggregate intrinsic value, end of period $ 1,089,594     $ 1,089,594 1,089,594   $ 1,463,052        
Exercisable, aggregate intrinsic value, end of period $ 727,568     $ 727,568 $ 727,568            
Net unrecognized compensation cost               $ 357,109      
Weighted average period for recognition of net unrecognized compensation cost         2 years 2 months 1 day            
Total fair value of stock options vested during period         $ 128,125 $ 206,701          
Stock Options [Member] | Minimum [Member]                      
Assumptions made in calculating fair values of options [Abstract]                      
Expected term           4 years 6 months          
Expected volatility           43.00%          
Risk-free interest rate           0.90%          
Stock Options [Member] | Maximum [Member]                      
Assumptions made in calculating fair values of options [Abstract]                      
Expected term           5 years          
Expected volatility           48.66%          
Risk-free interest rate           0.97%          
2008 Stock Incentive Plan [Member] | Stock Options [Member]                      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                      
Number of shares authorized under the plan (in shares)               750,000     625,000
Number of stock options outstanding under the plan (in shares) 264,177     264,177 264,177     264,177      
Increase in number of shares authorized (in shares)         125,000            
Number of stock options exercised under the plan (in shares)         470,724            
Stock options, number of shares [Roll forward]                      
Exercised (in shares)         470,724            
Outstanding, end of period (in shares) 264,177     264,177 264,177            
2014 Stock Incentive Plan [Member] | Stock Options [Member]                      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                      
Number of shares authorized under the plan (in shares)               800,000      
Number of stock options outstanding under the plan (in shares) 203,750     203,750 203,750     203,750      
Number of stock options exercised under the plan (in shares)         12,000            
Options or shares still available to be issued (in shares)               584,250      
Stock options, number of shares [Roll forward]                      
Exercised (in shares)         12,000            
Outstanding, end of period (in shares) 203,750     203,750 203,750            
Cost of Goods Sold [Member]                      
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]                      
Allocated share-based compensation expense $ 12,800   $ 0   $ 21,400 $ 0          
Research and Development Expense [Member]                      
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]                      
Allocated share-based compensation expense 12,100   27,300   65,200 34,700          
Selling, General and Administrative Expenses [Member]                      
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]                      
Allocated share-based compensation expense 48,800   65,400   123,000 111,500          
Africa [Member]                      
Revenues from External Customers [Line Items]                      
Net product sales 493,852   395,231   862,679 713,989          
Asia [Member]                      
Revenues from External Customers [Line Items]                      
Net product sales 92,596   88,984   1,513,018 64,005          
Europe [Member]                      
Revenues from External Customers [Line Items]                      
Net product sales 599,435   205,667   1,040,160 123,096          
North America [Member]                      
Revenues from External Customers [Line Items]                      
Net product sales 672,765   667,165   1,760,104 2,389,024          
South America [Member]                      
Revenues from External Customers [Line Items]                      
Net product sales $ 1,034,294   $ 677,025   3,144,353 $ 4,660,977          
RVR Diagnostics Sdn Bhd [Member]                      
Intangible assets [Abstract]                      
Intangible assets                 $ 1,800,000    
Amortization of intangible assets       $ 292,000 $ 292,000            
XML 31 R21.htm IDEA: XBRL DOCUMENT v3.7.0.1
COLLABORATIVE RESEARCH AND DEVELOPMENT AGREEMENTS (Details) - USD ($)
 1 Months Ended 6 Months Ended 12 Months Ended
Mar. 31, 2017
Sep. 30, 2016
Aug. 31, 2016
Apr. 30, 2016
Feb. 29, 2016
Oct. 31, 2015
Jan. 31, 2015
Jun. 30, 2017
Jun. 30, 2016
Dec. 31, 2016
Brain [Member]                    
Research and Development Arrangement, Contract to Perform for Others [Line Items]                    
Revenue earned from grant               $ 233,334 $ 188,098  
Revenue from grants from inception               1,000,000    
Maximum amount of development agreement             $ 946,000     $ 350,000
Malaria [Member]                    
Research and Development Arrangement, Contract to Perform for Others [Line Items]                    
Revenue earned from grant               159,000    
Revenue from grants from inception               678,000    
Maximum amount of development agreement       $ 678,000            
Fever Panel [Member]                    
Research and Development Arrangement, Contract to Perform for Others [Line Items]                    
Revenue earned from grant               0 $ 1,559,500  
Revenue from grants from inception               2,668,000    
Maximum amount of development agreement         $ 550,000 $ 2,118,000        
BARDA [Member]                    
Research and Development Arrangement, Contract to Perform for Others [Line Items]                    
Revenue earned from grant               880,000    
Revenue from grants from inception               1,353,000    
Maximum amount of development agreement     $ 5,934,000              
USDA Bovid Phase I [Member]                    
Research and Development Arrangement, Contract to Perform for Others [Line Items]                    
Maximum amount of development agreement   $ 99,646                
USDA Bovid Phase II [Member]                    
Research and Development Arrangement, Contract to Perform for Others [Line Items]                    
Maximum amount of development agreement   $ 600,000                
USDA Bovid [Member]                    
Research and Development Arrangement, Contract to Perform for Others [Line Items]                    
Revenue earned from grant               169,000    
Revenue from grants from inception               290,277    
FIND [Member]                    
Research and Development Arrangement, Contract to Perform for Others [Line Items]                    
Revenue earned from grant               339,000    
Revenue from grants from inception               $ 339,000    
Maximum amount of development agreement $ 999,000                  
XML 32 R22.htm IDEA: XBRL DOCUMENT v3.7.0.1
RIGHTS AGREEMENT (Details) - $ / shares
 6 Months Ended
Jun. 30, 2017
Dec. 31, 2016
RIGHTS AGREEMENT [Abstract]    
Preferred stock dividend declared for each common stock (in shares) 1  
Common stock, par value (in dollars per share) $ 0.01 $ 0.01
Minimum combined ownership of outstanding shares of common stock by acquiring person 20.00%  
XML 33 R23.htm IDEA: XBRL DOCUMENT v3.7.0.1
COMMON STOCK, WARRANTS AND OPTIONS (Details)
 3 Months Ended 6 Months Ended 12 Months Ended
Jan. 09, 2017
USD ($)
$ / shares
shares
Aug. 03, 2016
USD ($)
$ / shares
shares
Mar. 05, 2016
Installment
$ / shares
shares
Mar. 31, 2017
Executive
Installment
$ / shares
shares
Dec. 31, 2016
Installment
$ / shares
shares
Jun. 30, 2016
Director
Installment
$ / shares
shares
Jun. 30, 2017
$ / shares
shares
Dec. 31, 2016
$ / shares
shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                
Shares issued, price per share | $ / shares   $ 6.00            
Proceeds from issuance of common stock | $   $ 12,493,000            
Number of stock options exercised (in shares)       10,969       191,804
Common stock exercised on cashless basis (in shares)       3,039       125,750
Exercise price (in dollars per share) | $ / shares       $ 4.00        
Shares sold in underwritten public offering (in shares)   2,300,000            
Chief Executive Officer [Member]                
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                
Stock options issued to purchase common stock (in shares)             20,000  
Exercise price of stock option (in dollars per share) | $ / shares             $ 5.3666  
Minimum period after termination of employment to exercise stock options by employees             30 days  
Executive Team [Member]                
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                
Number of executives, stock option issued | Executive       6        
Stock options issued to purchase common stock (in shares)       5,000        
Exercise price of stock option (in dollars per share) | $ / shares       $ 5.25        
Expiration period of stock option             5 years  
BOD [Member]                
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                
Number of directors, stock option issued | Director           1    
Stock options issued to purchase common stock (in shares)           46,875    
Exercise price of stock option (in dollars per share) | $ / shares           $ 8.86    
Expiration period of stock option             5 years  
Number of equal annual installments with in which options are exercisable | Installment           5    
EVP [Member]                
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                
Stock options issued to purchase common stock (in shares)     60,000          
Exercise price of stock option (in dollars per share) | $ / shares     $ 5.64          
Options expected to vest in each anniversary (in shares)             20,000  
Number of equal annual installments with in which options are exercisable | Installment     3          
Minimum period after termination of employment to exercise stock options by employees             30 days  
President [Member]                
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                
Stock options issued to purchase common stock (in shares)         36,000      
Exercise price of stock option (in dollars per share) | $ / shares         $ 7.15      
Expiration period of stock option             5 years  
Number of equal annual installments with in which options are exercisable | Installment         3      
Vice President [Member]                
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                
Stock options issued to purchase common stock (in shares)       36,000        
Exercise price of stock option (in dollars per share) | $ / shares       $ 6.30        
Expiration period of stock option             5 years  
Number of equal annual installments with in which options are exercisable | Installment       3        
Minimum [Member]                
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                
Exercise price (in dollars per share) | $ / shares               $ 2.80
Maximum [Member]                
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                
Exercise price (in dollars per share) | $ / shares               $ 5.56
RVR Diagnostics Sdn Bhd [Member]                
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                
Cash payment | $ $ 1,400,000              
Contingent consideration | $ $ 148,000              
Shares issued (in shares) 269,236              
Shares held back (in shares) 7,277              
Share price (in dollars per share) | $ / shares $ 6.25              
XML 34 R24.htm IDEA: XBRL DOCUMENT v3.7.0.1
COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS (Details)
 3 Months Ended 6 Months Ended
Jun. 30, 2017
USD ($)
KeyEmployee
Jun. 30, 2016
USD ($)
Jun. 30, 2017
USD ($)
KeyEmployee
shares
Jun. 30, 2016
USD ($)
Dec. 31, 2016
USD ($)
Economic Dependency [Abstract]          
Sales $ 2,892,942 $ 2,034,072 $ 8,320,314 $ 7,951,091  
Accounts Receivable 4,671,627   4,671,627   $ 3,383,729
Accounts Payable $ 1,823,896   $ 1,823,896   $ 1,437,290
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]          
Number of key employees with whom Company has employment contracts | KeyEmployee 4   4    
Aggregate annual salaries of employment contracts     $ 1,000,000    
Customer Concentration Risk [Member] | Customer 1 [Member]          
Economic Dependency [Abstract]          
Accounts Receivable $ 2,729,804 3,389,505 2,729,804 3,389,505  
Customer Concentration Risk [Member] | Customer 2 [Member]          
Economic Dependency [Abstract]          
Accounts Receivable [1]  
Customer Concentration Risk [Member] | Customer 3 [Member]          
Economic Dependency [Abstract]          
Accounts Receivable [1]  
Customer Concentration Risk [Member] | Customer4 [Member]          
Economic Dependency [Abstract]          
Accounts Receivable [1]  
Supplier Concentration Risk [Member] | Vendor 1 [Member]          
Economic Dependency [Abstract]          
Accounts Payable [2] 60,935 [2] 60,935  
Supplier Concentration Risk [Member] | Vendor 2 [Member]          
Economic Dependency [Abstract]          
Accounts Payable [2]  
Supplier Concentration Risk [Member] | Vendor 3 [Member]          
Economic Dependency [Abstract]          
Accounts Payable 29,613 [2] $ 29,613 [2]  
Sperzel Contract [Member]          
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]          
Stock options issued to purchase common stock (in shares) | shares     20,000    
Esfandiari Contract [Member]          
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]          
Stock options issued to purchase common stock (in shares) | shares     60,000    
Vesting rights percentage of awards     33.33%    
Sales [Member] | Customer Concentration Risk [Member] | Customer 1 [Member]          
Economic Dependency [Abstract]          
Sales $ 956,207 $ 666,765 $ 2,895,794 $ 3,256,170  
Concentration risk, percentage 33.00% 33.00% 35.00% 41.00%  
Sales [Member] | Customer Concentration Risk [Member] | Customer 2 [Member]          
Economic Dependency [Abstract]          
Sales [1] [1] [1] $ 1,796,477  
Concentration risk, percentage [1] [1] [1] 23.00%  
Sales [Member] | Customer Concentration Risk [Member] | Customer 3 [Member]          
Economic Dependency [Abstract]          
Sales [1]   $ 1,326,171    
Concentration risk, percentage [1]   16.00%    
Sales [Member] | Customer Concentration Risk [Member] | Customer4 [Member]          
Economic Dependency [Abstract]          
Sales $ 399,482   $ 754,408    
Concentration risk, percentage 14.00%   9.00%    
Purchases [Member] | Supplier Concentration Risk [Member] | Vendor 1 [Member]          
Economic Dependency [Abstract]          
Concentration risk, percentage [2] 12.00% [2] 13.00%  
Purchases [2] $ 203,020 [2] $ 425,922  
Purchases [Member] | Supplier Concentration Risk [Member] | Vendor 2 [Member]          
Economic Dependency [Abstract]          
Concentration risk, percentage 32.00% [2] 26.00% [2]  
Purchases $ 698,838 [2] $ 698,838 [2]  
Purchases [Member] | Supplier Concentration Risk [Member] | Vendor 3 [Member]          
Economic Dependency [Abstract]          
Concentration risk, percentage 11.00% [2] [2] [2]  
Purchases $ 204,781 [2] [2] [2]  
[1] Product sales did not exceed 10% for the period indicated.
[2] Purchases did not exceed 10% for the period indicated.
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