Nevada
|
|
88-0425691
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(State or other jurisdiction of incorporation)
|
|
(IRS Employer Identification Number)
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|
Large accelerated filer □
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Accelerated filer □
|
|
Non-accelerated filer □
|
Smaller reporting company
x
|
|
(Do not check if a smaller reporting company)
|
|
|
Page
|
|
|
|
Part I. FINANCIAL INFORMATION:
|
|
|
|
Item 1. Financial Statements:
|
|
|
Condensed Consolidated Balance Sheets as of June 30, 2014 (unaudited) and December 31,
2013
|
2
|
|
|
|
|
Condensed Consolidated Statements of Operations (unaudited) for the
three and
six
months ended June 30, 2014 and
2013
|
3
|
|
|
|
|
Condensed Consolidated Statements of Cash Flows (unaudited) for the
six
months ended June 30, 2014 and
2013
|
4
|
|
|
|
|
Notes to Condensed Consolidated Financial Statements (unaudited)
|
5
|
|
|
|
|
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
|
13
|
|
|
|
|
Item 4. Controls and Procedures
|
23
|
|
|
|
Part II. OTHER INFORMATION:
|
|
|
|
|
|
|
Item 6. Exhibits
|
24
|
|
|
|
SIGNATURES
|
25
|
|
|
|
|
EXHIBITS
|
|
|
For the three months ended
|
For the six months ended
|
||||||||||||||
|
June 30, 2014
|
June 30, 2013
|
June 30, 2014
|
June 30, 2013
|
||||||||||||
REVENUES:
|
|
|
|
|
||||||||||||
Net product sales
|
$
|
7,248,470
|
$
|
5,061,691
|
$
|
12,152,635
|
$
|
11,374,881
|
||||||||
License and royalty revenue
|
6,971
|
-
|
7,131
|
-
|
||||||||||||
R&D, milestone and grant revenue
|
167,156
|
331,831
|
1,075,904
|
696,794
|
||||||||||||
TOTAL REVENUES
|
7,422,597
|
5,393,522
|
13,235,670
|
12,071,675
|
||||||||||||
|
||||||||||||||||
Cost of product sales
|
4,440,046
|
3,112,347
|
7,980,508
|
7,096,610
|
||||||||||||
|
||||||||||||||||
GROSS MARGIN
|
2,982,551
|
2,281,175
|
5,255,162
|
4,975,065
|
||||||||||||
|
||||||||||||||||
OPERATING EXPENSES:
|
||||||||||||||||
Research and development expenses
|
1,268,653
|
1,500,645
|
2,466,275
|
2,545,904
|
||||||||||||
Selling, general and administrative expenses
|
1,946,763
|
1,160,256
|
3,404,491
|
2,322,336
|
||||||||||||
|
3,215,416
|
2,660,901
|
5,870,766
|
4,868,240
|
||||||||||||
(LOSS) INCOME FROM OPERATIONS
|
(232,865
|
)
|
(379,726
|
)
|
(615,604
|
)
|
106,825
|
|||||||||
|
||||||||||||||||
OTHER INCOME (EXPENSE):
|
||||||||||||||||
(Loss) Gain on sale of fixed asset
|
(5,707
|
)
|
7,500
|
(5,707
|
)
|
7,500
|
||||||||||
Interest income
|
1,561
|
897
|
3,391
|
2,235
|
||||||||||||
Interest expense
|
-
|
-
|
-
|
(335
|
)
|
|||||||||||
|
(4,146
|
)
|
8,397
|
(2,316
|
)
|
9,400
|
||||||||||
|
||||||||||||||||
(LOSS) INCOME BEFORE INCOME TAXES
|
(237,011
|
)
|
(371,329
|
)
|
(617,920
|
)
|
116,225
|
|||||||||
|
||||||||||||||||
Income tax (benefit) provision
|
(91,030
|
)
|
(130,340
|
)
|
(247,200
|
)
|
40,090
|
|||||||||
|
||||||||||||||||
NET (LOSS) INCOME
|
$
|
(145,981
|
)
|
$
|
(240,989
|
)
|
$
|
(370,720
|
)
|
$
|
76,135
|
|||||
|
||||||||||||||||
Basic (loss) earnings per share
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.04
|
)
|
$
|
0.01
|
|||||
|
||||||||||||||||
Diluted (loss) earnings per share
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.04
|
)
|
$
|
0.01
|
|||||
|
||||||||||||||||
Weighted average number of shares outstanding, basic
|
9,555,944
|
9,259,506
|
9,448,160
|
8,664,478
|
||||||||||||
|
||||||||||||||||
Weighted average number of shares outstanding, diluted
|
9,555,944
|
9,259,506
|
9,448,160
|
9,230,840
|
a)
|
Basis of Presentation:
|
b) | Revenue Recognition |
c) | Inventories: |
|
June 30, 2014
|
December 31, 2013
|
||||||
Raw materials
|
$
|
2,087,691
|
$
|
1,710,627
|
||||
Work in process
|
709,290
|
464,481
|
||||||
Finished goods
|
1,282,225
|
1,013,618
|
||||||
|
$
|
4,079,206
|
$
|
3,188,726
|
d) | Earnings Per Share: |
|
For the three months ended
|
|
For the six months ended
|
||
|
June 30, 2014
|
June 30, 2013
|
|
June 30, 2014
|
June 30, 2013
|
1999, 2008 and 2014 Plan Stock Options
|
-
|
532,523
|
|
-
|
566,362
|
e) | Employee Stock Option Plan: |
|
For the three months ended
|
|
For the six months ended
|
||
|
June 30, 2014
|
June 30, 2013
|
|
June 30, 2014
|
June 30, 2013
|
Expected term (in years)
|
4.5
|
3.5
|
|
5.8
|
3.5
|
Expected volatility
|
61.50%
|
93.80%
|
|
61.50 % -
86.67 %
|
93.80 %-
101.30%
|
Expected dividend yield
|
0%
|
0%
|
|
0 %
|
0 %
|
Risk-free interest rate
|
0.83%
|
0.34%
|
|
0.83 % -
1.33 %
|
0.34 % -
0.40%
|
Stock Options
|
Number of Shares
|
Weighted Average Exercise Price per Share
|
Weighted Average Remaining Contractual Term
|
Aggregate Intrinsic Value
|
|||||||||
Outstanding at
December 31, 2013
|
656,398
|
$
|
2.57
|
1.65 years
|
$
|
801,888
|
|||||||
|
|
||||||||||||
Granted
|
343,750
|
3.43
|
|
||||||||||
Exercised
|
(318,750
|
)
|
1.04
|
|
|||||||||
Forfeited/expired/cancelled
|
(24,903
|
)
|
3.15
|
|
|||||||||
Outstanding at
June 30, 2014
|
656,495
|
$
|
3.62
|
4.42 years
|
$
|
110,112
|
|||||||
|
|
||||||||||||
Exercisable at
June 30, 2014
|
223,495
|
$
|
3.62
|
2.38 years
|
$
|
83,062
|
f) | Geographic Information: |
|
For the three months ended
|
For the six months ended
|
||||||||||||||
|
June 30, 2014
|
June 30, 2013
|
June 30, 2014
|
June 30, 2013
|
||||||||||||
Africa
|
$
|
418,343
|
$
|
1,009,899
|
$
|
1,249,805
|
$
|
1,857,221
|
||||||||
Asia
|
23,711
|
31,353
|
74,757
|
50,619
|
||||||||||||
Europe
|
34,966
|
69,324
|
71,025
|
76,929
|
||||||||||||
North America
|
2,769,529
|
2,464,060
|
6,532,678
|
5,285,578
|
||||||||||||
South America
|
4,001,921
|
1,487,055
|
4,224,370
|
4,104,534
|
||||||||||||
|
$
|
7,248,470
|
$
|
5,061,691
|
$
|
12,152,635
|
$
|
11,374,881
|
g) | Accounts Payable and Accrued Liabilities |
|
June 30, 2014
|
December 31, 2013
|
||||||
Accounts payable – suppliers
|
$
|
1,861,955
|
$
|
1,815,369
|
||||
Accrued commissions
|
500,220
|
371,905
|
||||||
Accrued royalties / license fees
|
675,932
|
1,028,286
|
||||||
Accrued payroll
|
289,276
|
328,564
|
||||||
Accrued vacation
|
264,168
|
203,444
|
||||||
Accrued bonuses
|
-
|
317,372
|
||||||
Accrued expenses – other
|
204,321
|
244,550
|
||||||
TOTAL
|
$
|
3,795,872
|
$
|
4,309,490
|
NOTE | 3 — COLLABORATIVE RESEARCH AND DEVELOPMENT ARRANGEMENTS: |
a) | National Institutes of Health (NIH) Grant: |
b) | Battelle/CDC DPP® Influenza Immunity Test: |
a) | Economic Dependency: |
|
|
For the three months ended
|
|
For the six months ended
|
|
Accounts Receivable as of
|
||||||||||||||
|
|
June 30, 2014
|
|
June 30, 2013
|
|
June 30, 2014
|
|
June 30, 2013
|
|
June 30, 2014
|
|
June 30, 2013
|
||||||||
|
|
Sales
|
|
% of Sales
|
|
Sales
|
|
% of Sales
|
|
Sales
|
|
% of Sales
|
|
Sales
|
|
% of Sales
|
|
|
|
|
Customer 1
|
$
|
1,462,460
|
|
20
|
$
|
2,305,729
|
|
46
|
$
|
4,165,432
|
|
34
|
$
|
4,895,683
|
|
43
|
$
|
538,934
|
$
|
905,829
|
Customer 2
|
|
1,215,872
|
|
17
|
|
*
|
|
*
|
|
2,217,242
|
|
18
|
|
*
|
|
*
|
|
689,250
|
|
-
|
Customer 3
|
|
3,964,903
|
|
55
|
|
650,221
|
|
13
|
|
4,166,801
|
|
34
|
|
1,869,096
|
|
16
|
|
3,137,726
|
|
712,950
|
|
For the three months ended
|
For the six months ended
|
Accounts Payable as of
|
|||||||||||||||||||||||
|
June 30, 2014
|
June 30, 2013
|
June 30, 2014
|
June 30, 2013
|
June 30, 2014
|
June 30, 2013
|
||||||||||||||||||||
|
Purchases
|
% of Purc.
|
Purchases
|
% of Purc.
|
Purchases
|
% of Purc.
|
Purchases
|
% of Purc.
|
|
|
||||||||||||||||
Vendor 1
|
$
|
341,534
|
13
|
$
|
239,539
|
6
|
$
|
622,220
|
14
|
$
|
565,384
|
9
|
$
|
90,469
|
$
|
67,945
|
||||||||||
Vendor 2
|
496,167
|
18
|
*
|
*
|
731,061
|
17
|
*
|
*
|
-
|
-
|
b) | Governmental Regulation: |
c) | Employment Agreement: |
Selected Product Categories:
|
For the three months ended
|
|
|
|||||||||||||
|
June 30, 2014
|
June 30, 2013
|
$ Change
|
% Change
|
||||||||||||
|
|
|
|
|
||||||||||||
Lateral Flow HIV Tests and Components
|
$
|
1,886,909
|
$
|
4,158,354
|
$
|
(2,271,445
|
)
|
-54.62
|
%
|
|||||||
DPP Tests and Components
|
5,167,025
|
694,816
|
4,472,209
|
643.65
|
%
|
|||||||||||
Other
|
194,536
|
208,521
|
(13,985
|
)
|
-6.71
|
%
|
||||||||||
Net Product Sales
|
7,248,470
|
5,061,691
|
2,186,779
|
43.20
|
%
|
|||||||||||
License and royalty revenue
|
6,971
|
-
|
6,971
|
100.00
|
%
|
|||||||||||
R&D, milestone and grant revenue
|
167,156
|
331,831
|
(164,675
|
)
|
-49.63
|
%
|
||||||||||
Total Revenues
|
$
|
7,422,597
|
$
|
5,393,522
|
$
|
2,029,075
|
37.62
|
%
|
For the three months ended
|
|
|
||||||||||||||
Gross Margin related to Net Product Sales:
|
June 30, 2014
|
June 30, 2013
|
$ Change
|
% Change
|
||||||||||||
|
|
|
|
|
||||||||||||
Gross Margin per Statement of Operations
|
$
|
2,982,551
|
$
|
2,281,175
|
$
|
701,376
|
30.75
|
%
|
||||||||
Less: R&D, milestone, grant, license and royalty revenues
|
174,127
|
331,831
|
(157,704
|
)
|
-47.53
|
%
|
||||||||||
Gross Margin from Net Product Sales
|
$
|
2,808,424
|
$
|
1,949,344
|
$
|
859,080
|
44.07
|
%
|
||||||||
Product Gross Margin %
|
38.75
|
%
|
38.51
|
%
|
Selected expense lines:
|
For the three months ended
|
|
|
|||||||||||||
|
June 30, 2014
|
June 30, 2013
|
$ Change
|
% Change
|
||||||||||||
Clinical and Regulatory Affairs:
|
|
|
|
|
||||||||||||
Wages and related costs
|
$
|
106,546
|
$
|
108,466
|
$
|
(1,920
|
)
|
-1.77
|
%
|
|||||||
Consulting
|
22,089
|
7,463
|
14,626
|
195.98
|
%
|
|||||||||||
Stock-based compensation
|
806
|
3,027
|
(2,221
|
)
|
-73.37
|
%
|
||||||||||
Clinical trials
|
29,712
|
421,768
|
(392,056
|
)
|
-92.96
|
%
|
||||||||||
Other
|
21,514
|
24,466
|
(2,952
|
)
|
-12.07
|
%
|
||||||||||
Total Regulatory
|
180,667
|
565,190
|
(384,523
|
)
|
-68.03
|
%
|
||||||||||
|
||||||||||||||||
R&D Other than Regulatory:
|
||||||||||||||||
Wages and related costs
|
614,897
|
538,789
|
76,108
|
14.13
|
%
|
|||||||||||
Consulting
|
68,801
|
42,326
|
26,475
|
62.55
|
%
|
|||||||||||
Stock-based compensation
|
8,631
|
19,334
|
(10,703
|
)
|
-55.36
|
%
|
||||||||||
Materials and supplies
|
288,438
|
251,716
|
36,722
|
14.59
|
%
|
|||||||||||
Other
|
107,219
|
83,290
|
23,929
|
28.73
|
%
|
|||||||||||
Total other than Regulatory
|
1,087,986
|
935,455
|
152,531
|
16.31
|
%
|
|||||||||||
|
||||||||||||||||
Total Research and Development
|
$
|
1,268,653
|
$
|
1,500,645
|
$
|
(231,992
|
)
|
-15.46
|
%
|
Selected expense lines:
|
For the three months ended
|
|
|
|||||||||||||
June 30, 2014
|
June 30, 2013
|
$ Change
|
% Change
|
|||||||||||||
|
|
|
|
|
||||||||||||
Wages and related costs
|
$
|
638,377
|
$
|
452,103
|
$
|
186,274
|
41.20
|
%
|
||||||||
Consulting
|
159,603
|
100,061
|
59,542
|
59.51
|
%
|
|||||||||||
Commissions
|
481,276
|
92,002
|
389,274
|
423.11
|
%
|
|||||||||||
Stock-based compensation
|
137,592
|
34,867
|
102,725
|
294.62
|
%
|
|||||||||||
Marketing materials
|
41,114
|
22,294
|
18,820
|
84.42
|
%
|
|||||||||||
Investor relations/investment bankers
|
41,277
|
39,023
|
2,254
|
5.78
|
%
|
|||||||||||
Legal, accounting and compliance
|
83,450
|
73,587
|
9,863
|
13.40
|
%
|
|||||||||||
Travel, entertainment and trade shows
|
111,914
|
69,554
|
42,360
|
60.90
|
%
|
|||||||||||
Other
|
252,160
|
276,765
|
(24,605
|
)
|
-8.89
|
%
|
||||||||||
Total S, G &A
|
$
|
1,946,763
|
$
|
1,160,256
|
$
|
786,507
|
67.79
|
%
|
|
For the three months ended
|
|
|
|||||||||||||
|
June 30, 2014
|
June 30, 2013
|
$ Change
|
% Change
|
||||||||||||
Other income (expense)
|
$
|
(5,707
|
)
|
$
|
7,500
|
$
|
(13,207
|
)
|
-176.09
|
%
|
||||||
Interest income
|
|
1,561
|
|
897
|
|
664
|
74.02
|
%
|
||||||||
Total Other Income and (Expense)
|
$
|
(4,146
|
)
|
$
|
8,397
|
$
|
(12,543
|
)
|
-149.37
|
%
|
Selected Product Categories:
|
For the six months ended
|
|
|
|||||||||||||
|
June 30, 2014
|
June 30, 2013
|
$ Change
|
% Change
|
||||||||||||
|
|
|
|
|
||||||||||||
Lateral Flow HIV Tests and Components
|
$
|
5,423,608
|
$
|
9,095,215
|
$
|
(3,671,607
|
)
|
-40.37
|
%
|
|||||||
DPP Tests and Components
|
6,335,795
|
1,837,651
|
4,498,144
|
244.78
|
%
|
|||||||||||
Other
|
393,232
|
442,015
|
(48,783
|
)
|
-11.04
|
%
|
||||||||||
Net Product Sales
|
12,152,635
|
11,374,881
|
777,754
|
6.84
|
%
|
|||||||||||
License and royalty revenue
|
7,131
|
-
|
7,131
|
100.00
|
%
|
|||||||||||
R&D, milestone and grant revenue
|
1,075,904
|
696,794
|
379,110
|
54.41
|
%
|
|||||||||||
Total Revenues
|
$
|
13,235,670
|
$
|
12,071,675
|
$
|
1,163,995
|
9.64
|
%
|
For the six months ended
|
|
|
||||||||||||||
Gross Margin related to Net Product Sales:
|
June 30, 2014
|
June 30, 2013
|
$ Change
|
% Change
|
||||||||||||
|
|
|
|
|
||||||||||||
Gross Margin per Statement of Operations
|
$
|
5,255,162
|
$
|
4,975,065
|
$
|
280,097
|
5.63
|
%
|
||||||||
Less: R&D, milestone, grant, license and royalty revenues
|
1,083,035
|
696,794
|
386,241
|
55.43
|
%
|
|||||||||||
Gross Margin from Net Product Sales
|
$
|
4,172,127
|
$
|
4,278,271
|
$
|
(106,144
|
)
|
-2.48
|
%
|
|||||||
Product Gross Margin %
|
34.33
|
%
|
37.61
|
%
|
Selected expense lines:
|
For the six months ended
|
|
|
|||||||||||||
|
June 30, 2014
|
June 30, 2013
|
$ Change
|
% Change
|
||||||||||||
Clinical and Regulatory Affairs:
|
|
|
|
|
||||||||||||
Wages and related costs
|
$
|
212,689
|
$
|
213,957
|
$
|
(1,268
|
)
|
-0.59
|
%
|
|||||||
Consulting
|
24,508
|
25,189
|
(681
|
)
|
-2.70
|
%
|
||||||||||
Stock-based compensation
|
3,231
|
14,632
|
(11,401
|
)
|
-77.92
|
%
|
||||||||||
Clinical trials
|
150,495
|
519,544
|
(369,049
|
)
|
-71.03
|
%
|
||||||||||
Other
|
39,758
|
28,544
|
11,214
|
39.29
|
%
|
|||||||||||
Total Regulatory
|
430,681
|
801,866
|
(371,185
|
)
|
-46.29
|
%
|
||||||||||
|
||||||||||||||||
R&D Other than Regulatory:
|
||||||||||||||||
Wages and related costs
|
1,182,670
|
1,046,583
|
136,087
|
13.00
|
%
|
|||||||||||
Consulting
|
113,351
|
52,163
|
61,188
|
117.30
|
%
|
|||||||||||
Stock-based compensation
|
24,457
|
47,641
|
(23,184
|
)
|
-48.66
|
%
|
||||||||||
Materials and supplies
|
524,596
|
432,896
|
91,700
|
21.18
|
%
|
|||||||||||
Other
|
190,520
|
164,755
|
25,765
|
15.64
|
%
|
|||||||||||
Total other than Regulatory
|
2,035,594
|
1,744,038
|
291,556
|
16.72
|
%
|
|||||||||||
|
||||||||||||||||
Total Research and Development
|
$
|
2,466,275
|
$
|
2,545,904
|
$
|
(79,629
|
)
|
-3.13
|
%
|
Selected expense lines:
|
For the six months ended
|
|
|
|||||||||||||
|
June 30, 2014
|
June 30, 2013
|
$ Change
|
% Change
|
||||||||||||
|
|
|
|
|
||||||||||||
Wages and related costs
|
$
|
1,328,879
|
$
|
893,575
|
$
|
435,304
|
48.71
|
%
|
||||||||
Consulting
|
263,350
|
106,261
|
157,089
|
147.83
|
%
|
|||||||||||
Commissions
|
511,711
|
251,910
|
259,801
|
103.13
|
%
|
|||||||||||
Stock-based compensation
|
186,726
|
103,533
|
83,193
|
80.35
|
%
|
|||||||||||
Marketing materials
|
65,100
|
29,257
|
35,843
|
122.51
|
%
|
|||||||||||
Investor relations/investment bankers
|
88,109
|
113,886
|
(25,777
|
)
|
-22.63
|
%
|
||||||||||
Legal, accounting and compliance
|
296,430
|
313,644
|
(17,214
|
)
|
-5.49
|
%
|
||||||||||
Travel, entertainment and trade shows
|
151,462
|
97,305
|
54,157
|
55.66
|
%
|
|||||||||||
Bad debt allowance (recovery)
|
-
|
(33,450
|
)
|
33,450
|
-100.00
|
%
|
||||||||||
Other
|
512,724
|
446,415
|
66,309
|
14.85
|
%
|
|||||||||||
Total S, G &A
|
$
|
3,404,491
|
$
|
2,322,336
|
$
|
1,082,155
|
46.60
|
%
|
|
For the six months ended
|
|
|
|||||||||||||
|
June 30, 2014
|
June 30, 2013
|
$ Change
|
% Change
|
||||||||||||
Other income (expense)
|
$
|
(5,707
|
)
|
$
|
7,500
|
$
|
(13,207
|
)
|
-176.09
|
%
|
||||||
Interest income
|
3,391
|
2,235
|
1,156
|
51.72
|
%
|
|||||||||||
Interest expense
|
-
|
(335
|
)
|
335
|
-100.00
|
%
|
||||||||||
Total Other Income and (Expense)
|
$
|
(2,316
|
)
|
$
|
9,400
|
$
|
(11,716
|
)
|
-124.64
|
%
|
Selected Changes in Financial Condition
|
As of
|
|
|
|||||||||||||
|
June 30, 2014
|
December 31, 2013
|
$ Change
|
% Change
|
||||||||||||
Cash and cash equivalents
|
$
|
6,835,057
|
$
|
9,650,275
|
$
|
(2,815,218
|
)
|
-29.17
|
%
|
|||||||
Accounts receivable, net of allowance for doubtful accounts of $24,000 at June 30, 2014 and December 31, 2013, respectively
|
5,423,418
|
4,592,121
|
831,297
|
18.10
|
%
|
|||||||||||
Inventories
|
4,079,206
|
3,188,726
|
890,480
|
27.93
|
%
|
|||||||||||
Fixed assets, net of accumulated depreciation
|
2,126,956
|
1,978,232
|
148,724
|
7.52
|
%
|
|||||||||||
Deposits and other assets
|
264,381
|
44,367
|
220,014
|
495.90
|
%
|
|||||||||||
Deferred tax asset, net of valuation allowance
|
3,816,007
|
3,590,207
|
225,800
|
6.29
|
%
|
|||||||||||
Accounts payable and accrued liabilities
|
3,795,872
|
4,309,490
|
(513,618
|
)
|
-11.92
|
%
|
|
For the six months ended
|
|
|
|||||||||||||
|
June 30, 2014
|
June 30, 2013
|
$ Change
|
% Change
|
||||||||||||
|
|
|
|
|
||||||||||||
Net cash (used in) provided by operating activities
|
$
|
(2,535,529
|
)
|
$
|
802,771
|
$
|
(3,338,300
|
)
|
-415.85
|
%
|
||||||
Net cash (used in) investing activities
|
(516,869
|
)
|
(415,649
|
)
|
(101,220
|
)
|
24.35
|
%
|
||||||||
Net cash provided by (used in) financing activities
|
237,180
|
5,306,411
|
(5,069,231
|
)
|
-95.53
|
%
|
||||||||||
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
$
|
(2,815,218
|
)
|
$
|
5,693,533
|
$
|
(8,508,751
|
)
|
-149.45
|
%
|
(a) | Disclosure Controls and Procedures . Under the supervision and with the participation of our senior management, consisting of our chief executive officer and our chief 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 (the "Evaluation Date"). Based on that evaluation, the Company's management, including our chief executive officer and chief financial officer, concluded that as of the Evaluation Date our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms. Our disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in our Exchange Act reports is accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate to allow timely decisions regarding required disclosure. |
(b) | Changes in Internal Control over Financial Reporting . There were no changes in our internal control over financial reporting identified in connection with the evaluation required by paragraph (d) of Rule 13a-15 or Rule 15d-15 under the Exchange Act that occurred during the Company's first six months of fiscal 2014 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. |
Number
|
Description
|
|
3.1
|
Articles of Incorporation, as amended. (1)
|
|
3.2
|
Amended and Restated Bylaws. (2)
|
|
4.1*
|
Form of Employee Option Agreement. (3)
|
|
4.2
|
1999 Equity Incentive Plan. (4)
|
|
4.3
|
2008 Stock Incentive Plan. (5)
|
|
4.4
|
Form of Option, for 2008 Stock Incentive Plan.
|
|
4.5
|
Rights Agreement, dated March 8, 2010 (6)
|
|
4.6
|
Form of Warrant (to be filed by amendment) [to be revised]
|
|
4.7
|
Form of Option, for 2014 Stock Incentive Plan.
|
|
10.1*
|
Employment Agreement dated March 13, 2014 with John J. Sperzel III
|
|
10.2*
|
Employment Agreement dated March 5, 2013 with Javan Esfandiari (10).
|
|
10.3*
|
Employment Agreement dated May 22, 2013 with Sharon Klugewicz (12)
|
|
10.3
|
HIV Barrel License, Marketing and Distribution Agreement, dated as of September 29, 2006, by and among the Registrant, Alere and StatSure. (8)
|
|
10.4
|
HIV Cassette License, Marketing and Distribution Agreement, dated as of September 29, 2006, between the Registrant and Alere. (8)
|
|
10.5
|
Non-Exclusive License, Marketing and Distribution Agreement, dated as of September 29, 2006, between the Registrant and Alere. (8)
|
|
10.6
|
Joint HIV Barrel Product Commercialization Agreement, dated as of September 29, 2006, between the Registrant and StatSure. (8)
|
|
10.8
|
Secured Revolving Demand Note, dated as of April 30, 2013, by and among the Registrant, Chembio Diagnostics Systems, Inc. and HSBC Bank, NA (12)
|
|
10.9
|
Loan and Security Agreement, dated as of April 30, 2013, by and among the Registrant, Chembio Diagnostics Systems, Inc. and HSBC Bank, NA (12)
|
|
14.1
|
Ethics Policy (9)
|
|
31.1
|
Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
32
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101.INS
|
XBRL Instance Document
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF
|
XBRL Taxonomy Definition Linkbase Document
|
|
101.LAB
|
XBRL Taxonomy Label Linkbase Document
|
|
101.PRE
|
XBRL Taxonomy Presentation Linkbase Document
|
|
|
|
|
1
|
Incorporated by reference to the Registrant's annual report on Form 10-KSB filed with the Commission on March 31, 2005.
|
|
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 annual report on Form 10-KSB filed with the Commission on March 12, 2008.
|
|
4
|
Incorporated by reference to the Registrant's definitive proxy statement on Schedule 14A filed with the Commission on May 11, 2005.
|
|
5
|
Incorporated by reference to the Registrant's definitive proxy statement on Schedule 14A filed with the Commission on April 14, 2008.
|
|
6
|
Incorporated by reference to the Registrant's registration statement on Form 8-A filed with the Commission on March 11, 2010.
|
|
7
|
Incorporated by reference to the Registrant's Current Report on Form 8-K filed with the Commission on June 21, 2006.
|
|
8
|
Incorporated by reference to the Registrant's Current Report on Form 8-K filed with the Commission on October 5, 2006.
|
|
9
|
Incorporated by reference to the Registrant's Annual Report on Form 10-KSB filed with the Commission on March 30, 2006.
|
|
10
|
Incorporated by reference to the Registrant's Annual Report on Form 10-K filed with the Commission on March 7, 2013.
|
|
11
|
Incorporated by reference to the Registrant's Current Report on Form 8-K filed with the Commission on April 25, 2013.
|
|
12
|
Incorporated by reference to the Registrant's Quarterly Report on Form 10-Q filed with the Commission on August 8, 2013.
|
|
(*)
|
An asterisk (*) beside an exhibit number indicates the exhibit contains a management contract, compensatory plan or arrangement which is required to be identified in this report.
|
|
||
Chembio Diagnostics, Inc.
|
||
|
|
|
Date:
|
August 7, 2014
|
By:
/s/ John J. Sperzel III
|
|
|
John J. Sperzel III
|
|
|
Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
Date:
|
August 7, 2014
|
By:
/s / Richard J. Larkin
|
|
|
Richard J. Larkin
|
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer)
|
I.
|
NOTICE OF STOCK OPTION GRANT
( The "Grant Notice")
|
Optionee:
|
|
___________________________________
|
Date of Stock Option Agreement:
|
|
___________________________________
|
Date of Grant:
|
|
___________________________________
|
Vesting Commencement Date:
|
|
___________________________________
|
Exercise Price per Share:
|
|
___________________________________
|
Total Number of Shares Granted:
|
|
___________________________________
|
Term/Expiration Date:
|
|
___________________________________
|
Vesting Schedule: | This Option shall become exercisable according to the following schedule of dates and numbers of Option Shares with respect to each date: |
II.
|
AGREEMENT
|
|
|
Date of Grant:
|
|
______________________________
|
Number of Option Shares as to which Option is Exercised:
|
|
|
Exercise Price per Share:
|
|
$____________
|
Total Exercise Price:
|
|
$____________
|
Certificate to be Issued in Name of:
|
|
|
Payment Delivered Herewith:
|
¨
|
$____________
|
Accepted by:
|
Submitted by:
|
CHEMBIO DIAGNOSTICS, INC.
|
OPTIONEE
|
By:
|
|
Name:
|
Name:
|
Its:
|
Address:
|