Nevada
|
|
88-0425691
|
(State
or other jurisdiction of incorporation)
|
|
(IRS
Employer Identification
Number)
|
|
|
Page
|
Part
I. FINANCIAL INFORMATION:
|
||
|
Item
1. Financial Statements:
|
|
|
Condensed
Consolidated Balance Sheets as of March 31, 2007 (unaudited) and
December
31, 2006.
|
F-2
|
|
|
|
|
Condensed
Consolidated Statements of Operations (unaudited) for the Three Months
ended March 31, 2007 and 2006.
|
F-3
|
|
Condensed
Consolidated Statements of Cash Flows (unaudited) for the Three Months
ended March 31, 2007 and 2006.
|
F-4
|
|
|
|
|
Notes
to Condensed Consolidated Financial Statements (unaudited)
|
F-5
to F-11
|
|
|
|
|
Item
2. Management's Discussion and Analysis and Plan of
Operation
|
1
|
|
|
|
|
Item
3. Controls and Procedures
|
6
|
|
|
|
Part
II. OTHER INFORMATION:
|
||
|
Item
6. Exhibits
|
6
|
|
|
|
SIGNATURES
|
|
8
|
|
|
|
EXHIBITS
|
|
CHEMBIO
DIAGNOSTIC SYSTEMS, INC. AND SUBSIDIARIES
|
|||||||
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|||||||
-
ASSETS -
|
|||||||
|
March
31, 2007
|
December
31, 2006
|
|||||
|
(Unaudited)
|
|
|||||
CURRENT
ASSETS:
|
|
|
|||||
Cash
|
$
|
3,848,665
|
$
|
4,290,386
|
|||
Accounts
receivable, net of allowance for doubtful accounts of $31,980 and
$42,967
for 2007 and 2006, respectively
|
1,051,629
|
1,350,240
|
|||||
Inventories
|
1,301,142
|
1,108,950
|
|||||
Prepaid
expenses and other current assets
|
194,582
|
204,092
|
|||||
TOTAL
CURRENT ASSETS
|
6,396,018
|
6,953,668
|
|||||
FIXED
ASSETS,
net of accumulated depreciation
|
558,515
|
603,603
|
|||||
OTHER
ASSETS:
|
|||||||
Deposits
and other assets
|
337,410
|
349,306
|
|||||
|
$
|
7,291,943
|
$
|
7,906,577
|
|||
|
|||||||
-
LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIENCY)-
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable and accrued liabilities
|
$
|
1,796,970
|
$
|
1,709,939
|
|||
Accrued
interest payable
|
63,160
|
93,160
|
|||||
Current
portion of obligations under capital leases
|
32,445
|
37,336
|
|||||
TOTAL
CURRENT LIABILITIES
|
1,892,575
|
1,840,435
|
|||||
OTHER
LIABILITIES:
|
|||||||
Obligations
under capital leases - net of current portion
|
1,703
|
7,081
|
|||||
Series
C redemption put
|
317,213
|
449,677
|
|||||
TOTAL
LIABILITIES
|
2,211,491
|
2,297,193
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
PREFERRED
STOCK - Series
C 7% Convertible - $.01 par value: 165 shares issued and outstanding
as of
2007 and 2006 - net of derivative liability of $317,213. Liquidation
preference of $8,533,937
|
6,818,010
|
6,549,191
|
|||||
STOCKHOLDERS’
EQUITY (DEFICIENCY):
|
|||||||
Preferred
Stock - 10,000,000 shares authorized:
|
|||||||
Series
A 8% Convertible - $.01 par value: 149.92119 shares issued and outstanding
as of 2007 and 2006. Liquidation preference of $4,647,556
|
2,594,266
|
2,504,313
|
|||||
Series
B 9% Convertible - $.01 par value: 113.18591 and 113.93591 shares
issued
and outstanding as of 2007 and 2006, respectively. Liquidation preference
of $5,791,700
|
3,400,480
|
3,555,786
|
|||||
Common
stock - $.01 par value; 100,000,000 shares authorized 11,754,015
and
11,296,961 shares issued and outstanding as of 2007 and 2006,
respectively
|
117,540
|
112,970
|
|||||
Additional
paid-in capital
|
20,306,434
|
19,960,618
|
|||||
Accumulated
deficit
|
(28,156,278
|
)
|
(27,073,494
|
)
|
|||
TOTAL
STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
(1,737,558
|
)
|
(939,807
|
)
|
|||
|
$
|
7,291,943
|
$
|
7,906,577
|
CHEMBIO
DIAGNOSTICS, INC. AND SUBSIDIARIES
|
|||||||
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|||||||
(UNAUDITED)
|
|||||||
Three
months ended
|
|||||||
March
31, 2007
|
March
31, 2006
|
||||||
REVENUES:
|
|
|
|||||
Net
sales
|
$
|
2,025,322
|
$
|
1,169,070
|
|||
Research
grant income
|
12,998
|
68,597
|
|||||
TOTAL
REVENUES
|
2,038,320
|
1,237,667
|
|||||
|
|||||||
Cost
of sales
|
1,378,501
|
802,128
|
|||||
|
|||||||
GROSS
PROFIT
|
659,819
|
435,539
|
|||||
|
|||||||
OVERHEAD
COSTS:
|
|||||||
Research
and development expenses
|
318,730
|
392,806
|
|||||
Selling,
general and administrative expenses
|
1,252,226
|
1,297,646
|
|||||
|
1,570,956
|
1,690,452
|
|||||
LOSS
FROM OPERATIONS
|
(911,137
|
)
|
(1,254,913
|
)
|
|||
|
|||||||
OTHER
INCOME (EXPENSES):
|
|||||||
Other
income
|
133,008
|
-
|
|||||
Interest
income
|
52,321
|
597
|
|||||
Interest
expense
|
(2,997
|
)
|
(9,398
|
)
|
|||
|
182,232
|
(8,801
|
)
|
||||
LOSS
BEFORE INCOME TAXES
|
(728,805
|
)
|
(1,263,714
|
)
|
|||
|
|||||||
Income
taxes
|
-
|
-
|
|||||
|
|||||||
NET
LOSS
|
(728,805
|
)
|
(1,263,714
|
)
|
|||
|
|||||||
Dividends
payable in stock to preferred stockholders
|
353,979
|
212,923
|
|||||
Dividend
accreted to preferred stock for associated costs and a beneficial
conversion feature
|
-
|
463,434
|
|||||
|
|||||||
NET
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$
|
(1,082,784
|
)
|
$
|
(1,940,071
|
)
|
|
|
|||||||
Basic
and diluted loss per share
|
$
|
(0.09
|
)
|
$
|
(0.22
|
)
|
|
|
|||||||
Weighted
average number of shares outstanding, basic and
diluted
|
11,717,079
|
9,004,466
|
CHEMBIO
DIAGNOSTICS, INC. AND SUBSIDIARIES
|
|||||||
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|||||||
(UNAUDITED)
|
|||||||
|
Three
months ended
|
||||||
|
March
31, 2007
|
March
31, 2006
|
|||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|||||
Net
loss
|
$
|
(728,805
|
)
|
$
|
(1,263,714
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
67,503
|
37,144
|
|||||
Provision
for doubtful accounts
|
10,987
|
(348
|
)
|
||||
Common
stock, options and warrants issued as compensation
|
16,408
|
136,423
|
|||||
Changes
in:
|
|||||||
Accounts
receivable
|
287,624
|
308,532
|
|||||
Inventories
|
(192,191
|
)
|
(230,181
|
)
|
|||
Prepaid
expenses and other current assets
|
9,510
|
48,454
|
|||||
Other
assets and deposits
|
11,896
|
-
|
|||||
Accounts
payable and accrued expenses
|
107,031
|
949,434
|
|||||
Net
cash used in operating activities
|
(410,037
|
)
|
(14,256
|
)
|
|||
|
|||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Acquisition
of fixed assets
|
(22,415
|
)
|
(183,283
|
)
|
|||
Net
cash used in investing activities
|
(22,415
|
)
|
(183,283
|
)
|
|||
|
|||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Sale of Series B Preferred Stock and associated warrants, net of
cash cost
of financing of $2,750
|
-
|
997,250
|
|||||
Payment
of accrued interest
|
(30,000
|
)
|
-
|
||||
Proceeds
from exercise of options
|
31,000
|
-
|
|||||
Payment
of capital lease obligation
|
(10,269
|
)
|
(9,201
|
)
|
|||
Payment of dividends
|
-
|
(140,226
|
)
|
||||
Net
cash (used in) provided by financing activities
|
(9,269
|
)
|
847,823
|
||||
|
|||||||
NET
(DECREASE) INCREASE IN CASH
|
(441,721
|
)
|
650,284
|
||||
Cash
- beginning of the period
|
4,290,386
|
232,148
|
|||||
|
|||||||
CASH
- end of the period
|
$
|
3,848,665
|
$
|
882,432
|
|||
|
|||||||
Supplemental
disclosure of cash flow information:
|
|||||||
Cash
paid during the period for interest
|
$
|
32,997
|
$
|
9,398
|
|||
Supplemental
disclosures for non-cash investing and financing
activities:
|
|||||||
Preferred
B issued as payment for financing fees
|
$
|
-
|
$
|
100,000
|
|||
Value
of warrants issued allocated to additional paid in capital
|
20,000
|
481,470
|
|||||
Accreted
beneficial conversion to preferred stock
|
-
|
463,434
|
|||||
Accreted
dividend to preferred stock
|
353,979
|
676,357
|
|||||
Value
of Common stock issued as payment of dividend
|
262,053
|
-
|
|||||
Value
of Preferred B issued as payment of dividend
|
-
|
89,899
|
|||||
Value
of Preferred A converted to common stock
|
-
|
47,884
|
|||||
Value
of Preferred B converted to common stock
|
20,925
|
202,740
|
NOTE
|
1
|
—
|
Description
of Business:
|
NOTE
|
2
|
—
|
SUMMARY
OF SIGNIFICANT ACCOUNTING
POLICIES:
|
(a) |
Basis
of Presentation:
|
(b) |
Inventories:
|
|
|
March
31, 2007
|
|
December 31, 2006
|
|
||
Raw
Materials
|
|
$
|
668,923
|
|
$
|
629,967
|
|
Work
in Process
|
|
|
268,383
|
|
|
257,208
|
|
Finished
Goods
|
|
|
363,836
|
|
|
221,775
|
|
|
|
$
|
1,301,142
|
|
$
|
1,108,950
|
|
(c) |
Earnings
Per Share
|
|
For
the three months ended
|
||
|
March
31, 2007
|
March
31, 2006
|
|
Basic
|
11,717,079
|
9,004,466
|
|
|
|||
Diluted
|
11,717,079
|
9,004,466
|
|
March
31, 2007
|
March
31, 2006
|
|
1999
Plan Stock Options
|
1,515,750
|
1,601,750
|
|
Other
Stock Options
|
144,625
|
144,625
|
|
Warrants
|
26,196,085
|
23,114,990
|
|
Convertible
Preferred Stock
|
27,086,060
|
17,574,184
|
(d) |
Employee
Stock Option Plan:
|
|
Three
Months Ended
|
||
|
March
31, 2007
|
March
31, 2006
|
|
Expected
term (in years)
|
5
|
5
|
|
Expected
volatility
|
104.80%
|
118.03%
|
|
Expected
dividend yield
|
0%
|
0%
|
|
Risk-free
interest rate
|
4.50%
|
4.66%
|
Stock
Options
|
Number
of Shares
|
Weighted
Average Exercise Price per Share
|
Weighted
Average Remaining Contractual Term
|
Aggregate
Intrinsic Value
|
|||||||||
Outstanding
at January 1, 2007
|
1,529,750
|
$
|
0.70
|
||||||||||
Granted
|
36,000
|
$
|
0.68
|
||||||||||
Exercised
|
(50,000
|
)
|
$
|
0.62
|
|
||||||||
Outstanding
at March 31, 2007
|
1,515,750
|
$
|
0.70
|
3.35
years
|
$
|
36,091
|
|||||||
|
|||||||||||||
Exercisable
at March 31, 2007
|
1,396,750
|
$
|
0.51
|
3.30
years
|
$
|
33,231
|
(e) |
Geographic
Information:
|
For
the three months ended
|
||||||
|
March
31, 2007
|
March
31, 2006
|
||||
Africa
|
$
|
368,624
|
|
$
|
210,464
|
|
Asia
|
|
41,213
|
|
|
42,811
|
|
Europe
|
|
27,011
|
|
|
38,698
|
|
Middle
East
|
|
118,959
|
|
|
675
|
|
North
America
|
|
1,460,925
|
|
|
59,961
|
|
South
America
|
|
8,590
|
|
|
816,461
|
|
|
$
|
2,025,322
|
|
$
|
1,169,070
|
|
(f) |
Accounts
payable and accrued
liabilities
|
March
31, 2007
|
December
31, 2006
|
||||||
Accounts
payable - suppliers
|
$
|
539,536
|
$
|
679,990
|
|||
Accrued
commissions
|
7,096
|
91,920
|
|||||
Accrued
royalties / licenses
|
568,657
|
461,048
|
|||||
Accrued
payroll
|
120,339
|
87,637
|
|||||
Accrued
vacation
|
206,050
|
214,858
|
|||||
Accrued
legal and accounting
|
101,920
|
7,000
|
|||||
Accrued
expenses - other
|
253,372
|
167,486
|
|||||
TOTAL
|
$
|
1,796,970
|
$
|
1,709,939
|
(g) |
Recent
Accounting Pronouncements affecting the
Company
|
NOTE
|
3
|
—
|
LONG-TERM
DEBT:
|
(a) |
Common
Stock
|
(b) |
Warrants
|
(c) |
Series
A 8% Convertible Preferred Stock:
|
(d) |
Series
B 9% Convertible Preferred Stock:
|
(e) |
Series
C
7% Convertible Preferred Stock:
|
(a) |
Economic
Dependency:
|
(b) |
Governmental
Regulation:
|
(a) |
Employment
Contract:
|
(b) |
New
Facility Lease:
|
OBLIGATIONS
|
Total
|
Less
than
1
Year
|
1-3
Years
|
4-5
Years
|
Greater
than
5
Years
|
|||||||||||
Capital
Leases (1)
|
$
|
35,986
|
$
|
34,242
|
$
|
1,744
|
$
|
-
|
$
|
-
|
||||||
Operating
Leases
|
$
|
269,195
|
$
|
127,151
|
$
|
142,044
|
$
|
-
|
$
|
-
|
||||||
Other
Long Term Obligations(2)
|
$
|
1,129,583
|
$
|
509,583
|
$
|
545,000
|
$
|
25,000
|
$
|
50,000
|
||||||
Total
Obligations
|
$
|
1,434,764
|
$
|
670,976
|
$
|
688,788
|
$
|
25,000
|
$
|
50,000
|
(1)
|
This
represents capital leases used to purchase capital
equipment.
|
(2)
|
This
represents contractual obligations for fixed cost licenses and employment
contracts.
|
· |
Inverness
will market the SURE CHECK product under Inverness brands globally
[subject only to certain existing international agreements that each
of
the Company and StatSure may keep in place for up to one year];
|
· |
Inverness
will exclusively market SURE CHECK as well as any new HIV products
in the
“barrel field” that are developed, and may not compete with any products
in the “barrel field” as defined in the agreement worldwide
;
|
· |
The
Company and StatSure have each granted Inverness exclusive rights
to their
intellectual property in the HIV barrel field;
and
|
· |
Inverness
has a first right to negotiate agreements to market and distribute
any of
the Company’s new HIV antibody detection products which it has developed,
including those that may incorporate the Company’s patent-pending Dual
Path Platform (DPP(TM)).
|
· |
Inverness
will market this product in the United States market only, and the
Company
has a non-exclusive license under the Inverness lateral flow patents
to
continue to market the product under the Company’s brand in the rest of
the world;
|
· |
Inverness
may bring a competitive HIV cassette product to the United States
market,
but in that event the Company may expand its lateral flow license
for this
product to the United States and have other options under the agreement;
and
|
· |
The
Company received a non-exclusive license under the Inverness lateral
flow
patents for its HIV 1/2 STAT-PAK cassette for marketing outside the
United
States.
|
· |
The
Company received a non-exclusive license under the Inverness lateral
flow
patents for its HIV 1/2 STAT-PAK Dipstick for marketing outside the
United
States;
|
· |
The
Company received a worldwide non-exclusive license to manufacture
and
market a number of other Company-branded products under the Inverness
lateral flow patents, including all the Company’s rapid tests for human
and veterinary and tuberculosis, Chagas disease, and tests for other
defined emerging and neglected diseases;
and
|
· |
Inverness
has the right to market each of these products (except the HIV 1/2
STAT
PAK Dipstick) under an Inverness brand pursuant to an agreed-upon
pricing
and margin sharing formula similar to the other
agreements.
|
Date:
|
May
11, 2007
|
By:
/s/ Lawrence A. Siebert
|
|
|
Lawrence
A. Siebert
|
|
|
Chief
Executive Officer
(Principal
Executive Officer)
|
|
|
|
Date:
|
May
11, 2007
|
By:
/s / Richard J. Larkin
|
|
|
Richard
J. Larkin
|
|
|
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
|