CHEMBIO DIAGNOSTICS, INC. - Quarter Report: 2009 March (Form 10-Q)
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
_______________________________
FORM
10 - Q
_______________________________
QUARTERLY REPORT UNDER
SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT
OF 1934.
For
the quarterly period ended March 31, 2009
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)
(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 X No
_____
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer”,
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.
Large accelerated filer [
]
Accelerated filer [
]
Non-accelerated filer [
]
Smaller reporting company [X]
(Do
not check if a smaller reporting company)
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes ____
No X
As of May
6, 2009, the Registrant had 61,944,901 shares outstanding of its $.01 par value
common stock.
Quarterly
Report on FORM 10-Q For The Period Ended
March
31, 2009
Table
of Contents
Chembio
Diagnostics, Inc.
Page
|
||
Part I.
FINANCIAL INFORMATION:
|
||
Item
1. Financial Statements:
|
||
Condensed
Consolidated Balance Sheets as of March 31, 2009 (unaudited) and December
31, 2008.
|
F-2
|
|
Condensed
Consolidated Statements of Operations (unaudited) for the Three months
ended March 31, 2009 and 2008.
|
F-3
|
|
Condensed
Consolidated Statements of Cash Flows (unaudited) for the Three months
ended March 31, 2009 and 2008.
|
F-4
|
|
Notes
to Condensed Consolidated Financial Statements
(unaudited)
|
F-5 to
F-11
|
|
Item
2. Management's Discussion and Analysis of Financial Condition and Results
of Operations
|
1
|
|
Item
4. Controls and Procedures
|
6
|
|
Part
II. OTHER INFORMATION:
|
||
Item
2. Unregistered Sales Of Equity Securities And Use Of
Proceeds
|
7
|
|
Item
5. Other Information
|
7
|
|
Item
6. Exhibits
|
9
|
|
SIGNATURES
|
10
|
|
EXHIBITS
|
F-1
PART
I
Item
1. FINANCIAL STATEMENTS
CHEMBIO DIAGNOSTICS,
INC. AND SUBSIDIARIES
|
||||||||
CONDENSED CONSOLIDATED
BALANCE SHEETS
|
||||||||
AS
OF
|
||||||||
-
ASSETS -
|
||||||||
March
31, 2009
|
December
31, 2008
|
|||||||
(UNAUDITED)
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 1,292,390 | $ | 1,212,222 | ||||
Accounts
receivable, net of allowance for doubtful accounts of $10,301 for 2009 and
2008
|
622,324 | 809,303 | ||||||
Inventories
|
1,680,424 | 1,819,037 | ||||||
Prepaid
expenses and other current assets
|
236,592 | 225,153 | ||||||
TOTAL
CURRENT ASSETS
|
3,831,730 | 4,065,715 | ||||||
FIXED ASSETS, net of
accumulated depreciation
|
783,198 | 881,406 | ||||||
OTHER
ASSETS:
|
||||||||
License
agreements, net of current portion
|
901,875 | 940,000 | ||||||
Deposits
and other assets
|
179,900 | 27,820 | ||||||
$ | 5,696,703 | $ | 5,914,941 | |||||
-
LIABILITIES AND STOCKHOLDERS’ EQUITY -
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable and accrued liabilities
|
$ | 2,110,946 | $ | 2,383,021 | ||||
Deferred
research and development revenue
|
367,591 | - | ||||||
Current
portion of obligations under capital leases
|
19,433 | 18,780 | ||||||
TOTAL
CURRENT LIABILITIES
|
2,497,970 | 2,401,801 | ||||||
OTHER
LIABILITIES:
|
||||||||
Obligations
under capital leases - net of current portion
|
55,697 | 60,808 | ||||||
License
fee payable - net of current portion
|
875,000 | 875,000 | ||||||
TOTAL
LIABILITIES
|
3,428,667 | 3,337,609 | ||||||
COMMITMENTS
AND CONTINGENCIES
|
||||||||
STOCKHOLDERS’
EQUITY:
|
||||||||
Preferred
stock – 10,000,000 shares authorized, none outstanding
|
- | - | ||||||
Common
stock - $.01 par value; 100,000,000 shares authorized 61,944,901 shares
issued and outstanding as of 2009 and 2008
|
619,449 | 619,449 | ||||||
Additional
paid-in capital
|
39,268,286 | 39,252,350 | ||||||
Accumulated
deficit
|
(37,619,699 | ) | (37,294,467 | ) | ||||
TOTAL
STOCKHOLDERS’ EQUITY
|
2,268,036 | 2,577,332 | ||||||
$ | 5,696,703 | $ | 5,914,941 | |||||
See
accompanying notes
|
F-2
CHEMBIO DIAGNOSTICS,
INC. AND SUBSIDIARIES
|
||||||||
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
|
||||||||
FOR THE THREE MONTHS
ENDED
|
||||||||
(UNAUDITED)
|
||||||||
March
31, 2009
|
March
31, 2008
|
|||||||
REVENUES:
|
||||||||
Net
sales
|
$ | 2,269,417 | $ | 2,237,971 | ||||
Research
grant income
|
276,181 | 126,757 | ||||||
TOTAL
REVENUES
|
2,545,598 | 2,364,728 | ||||||
Cost
of sales
|
1,546,908 | 1,531,560 | ||||||
GROSS
PROFIT
|
998,690 | 833,168 | ||||||
OPERATING
EXPENSES:
|
||||||||
Research
and development expenses
|
647,372 | 626,336 | ||||||
Selling,
general and administrative expenses
|
675,813 | 1,018,400 | ||||||
1,323,185 | 1,644,736 | |||||||
LOSS
FROM OPERATIONS
|
(324,495 | ) | (811,568 | ) | ||||
OTHER
INCOME (EXPENSES):
|
||||||||
Interest
income
|
3,384 | 18,979 | ||||||
Interest
expense
|
(4,121 | ) | (5,593 | ) | ||||
(737 | ) | 13,386 | ||||||
LOSS
BEFORE INCOME TAXES
|
(325,232 | ) | (798,182 | ) | ||||
Provision
for income taxes
|
- | - | ||||||
NET
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$ | (325,232 | ) | $ | (798,182 | ) | ||
Basic
and diluted loss per share
|
$ | (0.01 | ) | $ | (0.01 | ) | ||
Weighted
average number of shares outstanding, basic and diluted
|
61,944,901 | 60,537,534 | ||||||
See
accompanying notes
|
F-3
CHEMBIO DIAGNOSTICS,
INC. AND SUBSIDIARIES
|
||||||||
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
||||||||
FOR THE THREE MONTHS
ENDED
|
||||||||
(UNAUDITED)
|
||||||||
March
31, 2009
|
March
31, 2008
|
|||||||
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS:
|
||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Cash
received from customers
|
$ | 2,732,577 | $ | 2,358,174 | ||||
Cash
paid to suppliers and employees
|
(2,495,973 | ) | (3,245,657 | ) | ||||
Interest
received
|
3,384 | 18,979 | ||||||
Interest
paid
|
(4,121 | ) | (5,593 | ) | ||||
Net
cash provided by (used in) operating activities
|
235,867 | (874,097 | ) | |||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Acquisition
of and deposits on fixed assets
|
(151,241 | ) | (179,272 | ) | ||||
Net
cash used in investing activities
|
(151,241 | ) | (179,272 | ) | ||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Payment
of capital lease obligation
|
(4,458 | ) | (9,265 | ) | ||||
Net
cash used in financing activities
|
(4,458 | ) | (9,265 | ) | ||||
NET
INCREASE (DECREASE) IN CASH AND CASH
EQUIVALENTS
|
80,168 | (1,062,634 | ) | |||||
Cash
and cash equivalents - beginning of the period
|
1,212,222 | 2,827,369 | ||||||
Cash
and cash equivalents - end of the period
|
$ | 1,292,390 | $ | 1,764,735 | ||||
RECONCILIATION
OF NET LOSS TO NET CASH PROVIDED BY (USED IN) OPERATING
ACTIVITIES:
|
||||||||
Net
loss
|
$ | (325,232 | ) | $ | (798,182 | ) | ||
Adjustments:
|
||||||||
Depreciation
and amortization
|
99,449 | 75,854 | ||||||
Provision
for doubtful accounts
|
- | 16,000 | ||||||
Common
stock, options and warrants issued as compensation
|
17,184 | 174,090 | ||||||
Changes
in assets and liabilities:
|
||||||||
Accounts
receivable
|
186,979 | (22,554 | ) | |||||
Inventories
|
138,613 | (51,601 | ) | |||||
Prepaid
expenses and other assets
|
(12,687 | ) | (86,552 | ) | ||||
Other
assets and deposits
|
36,045 | (859,806 | ) | |||||
Deferred
revenue
|
367,591 | (12,501 | ) | |||||
Accounts
payable and accrued expenses
|
(272,075 | ) | (183,845 | ) | ||||
Licenses
fee payable
|
- | 875,000 | ||||||
Net
cash provided by (used in) operating activities
|
$ | 235,867 | $ | (874,097 | ) | |||
Supplemental
disclosures for non-cash investing and financing
activities:
|
||||||||
NONE
|
||||||||
See
accompanying notes
|
F-4
CHEMBIO DIAGNOSTICS, INC.
AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2009
(UNAUDITED)
NOTE
1—DESCRIPTION OF BUSINESS:
Chembio
Diagnostics, Inc. (the “Company” or “Chembio”) and its subsidiaries develop,
manufacture, and market rapid diagnostic tests that detect infectious diseases.
The Company’s main 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. Rapid HIV
tests represented nearly 70% of the Company’s product revenues in the first
quarter of 2009. The Company’s products are sold to medical
laboratories and hospitals, governmental and public health entities,
non-governmental organizations, medical professionals and retail establishments.
Chembio’s products are sold under the Company’s STAT PAK® or SURE CHECK ®
registered trademarks or under the private labels of its marketing partners, for
example the Clearview® label owned by Inverness Medical Innovations, Inc., which
is the Company’s exclusive marketing partner for its rapid HIV lateral flow test
products in the United States. These products employ lateral flow
technologies that are proprietary, including those licensed to the
Company. All of the Company’s 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. In 2008, the Company completed development of its first
two products that employ the DPP® and the Company has a number of additional
products under development that employ the DPP®.
The
accompanying consolidated financial statements have been prepared in conformity
with accounting principles generally accepted in the United States of America,
which contemplate continuation of the Company as a going concern. Although
revenues and gross margins increased in the year ended December 31, 2008 as
compared to the same period in 2007, the Company continues to generate
significant operating losses. At March 31, 2009, the Company had stockholders’
equity of $2,268,000 and working capital of $1,334,000. The Company estimates
that its resources are sufficient to fund its needs through the next twelve
months or that, in the alternative, it could raise additional capital although
the terms under which that capital could be raised would likely be very dilutive
to current shareholders. The Company’s liquidity and cash
requirements will depend on several factors. These factors include (1) the level
of revenues; (2) the extent to which, if any, that revenue level improves
operating cash flows; (3) the Company’s investments in research and development,
facilities, marketing, regulatory approvals, and other investments it may
determine to make; and (4) the investment in capital equipment (including
production equipment of $323,500 that the Company has contracted for) and the
extent to which the Company improves cash flow through operating
efficiencies. There are no assurances that the Company will become profitable or
generate positive cash flow by the end of 2009 or, in the alternative, be
successful in raising sufficient capital to fund its needs through March 31,
2010.
NOTE
2—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
(a)
|
Basis
of Presentation:
|
The
consolidated interim financial information as of March 31, 2009 and for the
three-month periods ended March 31, 2009 and 2008 have been prepared
without audit, pursuant to the rules and regulations of the Securities and
Exchange Commission (the “SEC”). Certain information and footnote
disclosures 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,
2008, previously filed with the SEC.
In the
opinion of management, all adjustments (which include normal recurring
adjustments) necessary to present a fair statement of consolidated financial
position as of March 31, 2009, and consolidated results of operations, and cash
flows for the three month-periods ended March 31, 2009 and 2008, 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)
|
Inventories:
|
Inventory consists of the following at:
March
31, 2009
|
December
31, 2008
|
|||||||
Raw
materials
|
$ | 775,060 | $ | 836,446 | ||||
Work
in process
|
326,303 | 300,986 | ||||||
Finished
goods
|
579,061 | 681,605 | ||||||
$ | 1,680,424 | $ | 1,819,037 |
F-5
CHEMBIO DIAGNOSTICS, INC.
AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2009
(UNAUDITED)
(c)
|
Earnings
Per Share:
|
The following weighted average number of shares was used for the computation of
basic and diluted loss per share:
For the three months ended
|
||||||||
March
31, 2009
|
March
31, 2008
|
|||||||
Basic
|
61,944,901
|
60,537,534
|
||||||
Diluted
|
61,944,901
|
60,537,534
|
Basic
loss per share is computed by dividing net loss attributable to common
stockholders by the weighted-average number of common shares outstanding for the
period. Diluted loss per share reflects the potential dilution from the exercise
or conversion of other securities into Common Stock, but only if dilutive.
Diluted loss per share for the three-month periods ended March 31, 2009 and 2008
is the same as basic loss per share, since the effects of the calculation were
anti-dilutive due to the fact that the Company incurred losses for all periods
presented. The following securities, presented on a common share equivalent
basis, have been excluded from the per share computations:
For the three months ended
|
||||||||
March
31, 2009
|
March
31, 2008
|
|||||||
1999
& 2008 Plan Stock Options
|
2,377,772
|
2,291,269
|
||||||
Other
Stock Options
|
124,625
|
124,625
|
||||||
Warrants
|
10,163,244
|
19,487,099
|
||||||
12,665,641
|
21,902,993
|
(d)
|
Reclassifications:
|
Certain
reclassifications have been made to conform to the 2009
presentation. For the three months ended March 31, 2008 the Company
reclassified its royalty and license expenses to cost of goods sold, from
selling, general and administrative expenses.
(e)
|
Employee
Stock Option Plan:
|
The
Company has a 1999 Stock Option Plan (“SOP”) that originally covered 1,500,000
shares of Common Stock. Under the terms of the SOP, the Compensation Committee
of the Company’s board is authorized to grant incentive options to key employees
and to grant non-qualified options to key employees and key individuals. The
options become exercisable at such times and under such conditions as determined
by the Compensation Committee. The SOP was amended at the Company’s
2005 stockholders’ meeting. The number of options under the SOP was
increased to cover 3,000,000 shares of Common Stock. It was also
amended to allow independent directors to be eligible for grants under the
portion of the SOP concerning non-qualified options.
Effective
June 3, 2008, the Company’s stockholders voted to approve the 2008 Stock
Incentive Plan (“SIP”). 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. 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.
As a
result of the adoption of FAS 123(R), the Company's results for the three-month
periods ended March 31, 2009 and 2008 include share-based compensation expense
totaling $17,000 and $159,000, respectively. Such amounts have been
included in the Condensed Consolidated Statements of Operations within cost
of goods sold (none and $19,000, respectively), research and development ($7,000
and $59,000, respectively) and selling, general and administrative expenses
($10,000 and $81,000, respectively). No income tax benefit has been
recognized in the income statement for share-based compensation arrangements due
to the history of operating losses.
Stock
option compensation expense in the three-month periods ended March 31, 2009 and
2008 represent the estimated fair value of options outstanding which are
being amortized on a straight-line basis over the requisite vesting period of
the entire award.
F-6
CHEMBIO DIAGNOSTICS, INC.
AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2009
(UNAUDITED)
The
weighted average estimated fair value of stock options granted in the
three-month periods ended March 31, 2009 and 2008 was none and $.42 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 historical volatility of our stock and other
contributing factors. The expected term is determined using the simplified
method as permitted by SAB 107, as the Company has no history of employee
exercise of options to-date.
The
assumptions made in calculating the fair values of options are as
follows:
For the three months
ended
|
||||
March
31, 2009
|
|
March
31, 2008
|
||
Expected
term (in years)
|
n/a
|
1
to 4
|
||
Expected
volatility
|
n/a
|
109.33%
|
||
Expected
dividend yield
|
n/a
|
n/a
|
||
Risk-free
interest rate
|
n/a
|
1.91%
to 2.46%
|
The
Company did not grant options under the Plans (SOP, SIP) during the three months
ended March 31, 2009.
The
following table provides stock option activity for the three months ended March
31, 2009:
Stock
Options
|
Number
of Shares
|
Weighted
Average Exercise Price per Share
|
Weighted
Average Remaining Contractual Term
|
Aggregate
Intrinsic Value
|
|||||||||
Outstanding
at January 1, 2008
|
2,201,500 | $ | 0.64 | ||||||||||
Impact of re-price
(for accounting purposes treated as a cancelation and
re-issue):
|
|||||||||||||
effect
as if cancelled
|
(1,846,500 | ) | $ | 0.64 | |||||||||
effect
as if re-issiued
|
1,846,500 | $ | 0.48 | ||||||||||
Granted
|
967,650 | $ | 0.18 | ||||||||||
Exercised
|
- | - | |||||||||||
Forfeited/expired
/cancelled
|
(752,500 | ) | $ | 0.58 | |||||||||
Outstanding
at December 31, 2008
|
2,416,650 | $ | 0.36 |
3.23
years
|
$ | - | |||||||
Granted
|
- | - | |||||||||||
Exercised
|
- | - | |||||||||||
Forfeited/expired
|
(62,250 | ) | $ | 0.28 | |||||||||
Outstanding
at March 31, 2009
|
2,354,400 | $ | 0.37 |
2.97
years
|
$ | - | |||||||
Exercisable
at March 31, 2009
|
1,994,400 | $ | 0.38 |
2.86
years
|
$ | - |
As of
March 31, 2009, there was $38,500 of net unrecognized compensation cost related
to stock options that had not vested, which is expected to be recognized over a
weighted average period of approximately 2.12 years. The total fair
value of stock options vested during the three-month periods ended March 31,
2009 and 2008, was approximately $47,000 and $139,000,
respectively.
See Note
5(b) regarding additional options issued to employees and a re-pricing of
existing employee options subsequent to March 31, 2009.
(f)
|
Geographic
Information:
|
SFAS No. 131, “Disclosures about
Segments of an Enterprise and Related Information” establishes
standards for the way that 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 product and services, geographic areas, and major
customers.
F-7
CHEMBIO DIAGNOSTICS, INC.
AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2009
(UNAUDITED)
The
Company produces only one group of similar products known collectively as “rapid
medical tests”. As per the provisions of SFAS 131, management believes that it
operates in a single business segment. Net sales by geographic area are as
follows:
For the three months ended
|
||||||||
March
31, 2009
|
March
31, 2008
|
|||||||
Africa
|
$ | 459,737 | $ | 1,286,762 | ||||
Asia
|
22,141 | 101,009 | ||||||
Europe
|
18,685 | 43,940 | ||||||
Middle
East
|
32,047 | 100,841 | ||||||
North
America
|
919,027 | 635,765 | ||||||
South
America
|
817,780 | 69,654 | ||||||
$ | 2,269,417 | $ | 2,237,971 |
(g)
|
Accounts
payable and accrued liabilities
|
Accounts payable and accrued
liabilities consist of:
March
31, 2009
|
December
31, 2008
|
|||||||
Accounts
payable – suppliers
|
$ | 422,767 | $ | 634,083 | ||||
Accrued
commissions
|
71,721 | 67,857 | ||||||
Accrued
royalties / license fees
|
1,283,318 | 1,400,941 | ||||||
Accrued
payroll
|
139,511 | 95,135 | ||||||
Accrued
vacation
|
113,989 | 91,895 | ||||||
Accrued
legal and accounting
|
30,000 | 18,000 | ||||||
Accrued
expenses – other
|
49,640 | 75,110 | ||||||
TOTAL
|
$ | 2,110,946 | $ | 2,383,021 |
(h)
|
Recent
Accounting Pronouncements affecting the
Company
|
In
September 2006, the Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Accounting Standards (“FAS”) No. 157, Fair Value
Measurements, which defines fair value, establishes a framework for measuring
fair value in generally accepted accounting principles, and expands disclosures
about fair value measurements. This statement does not require any new fair
value measurements, but provides guidance on how to measure fair value by
providing a fair value hierarchy used to classify the source of the information.
FAS No. 157 is effective for fiscal years beginning after November 15,
2007, and all interim periods within those fiscal years. In February 2008, the
FASB released FASB Staff Position (FSP FAS 157-2 – Effective Date of FASB
Statement No. 157) which delays the effective date of FAS No. 157 for
all nonfinancial assets and nonfinancial liabilities, except those that are
recognized or disclosed at fair value in the financial statements on a recurring
basis (at least annually), to fiscal years beginning after November 15, 2008 and
interim periods within those fiscal years. The implementation of FAS
No. 157 for financial assets and liabilities, effective January 1,
2008, did not have an impact on the Company’s financial position and results of
operations. The Company has evaluated the impact of adoption of this
statement on its nonfinancial assets and liabilities and concluded that it did
not have an impact on the Company’s financial position, results of operations,
or cash flows for the first quarter of fiscal 2009.
In
December 2007, the FASB issued FAS No. 141 (revised 2007), Business
Combinations, which replaces FAS No 141. The statement retains the purchase
method of accounting for acquisitions, but requires a number of changes,
including changes in the way assets and liabilities are recognized in the
purchase accounting. It also changes the recognition of assets acquired and
liabilities assumed arising from contingencies, requires the capitalization of
in-process research and development at fair value, and requires the expensing of
acquisition-related costs as incurred. FAS No. 141R is effective
for business combinations for which the acquisition date is on or after the
beginning of the first annual reporting period beginning on or after December
15, 2008. The adoption of FAS 141R has not had an impact on the Company’s
financial statements.
F-8
CHEMBIO DIAGNOSTICS, INC.
AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2009
(UNAUDITED)
In
December 2007, the FASB issued FAS No. 160, “Noncontrolling Interests in
Consolidated Financial Statements – an Amendment of ARB No. 51.” FAS
160 establishes accounting and reporting standards pertaining to ownership
interests in subsidiaries held by parties other than the parent, the amount of
net income attributable to the parent and to the noncontrolling interest,
changes in a parent’s ownership interest, and the valuation of any retained
noncontrolling equity investment when a subsidiary is
deconsolidated. This statement also establishes disclosure
requirements that clearly identify and distinguish between the interests of the
parent and the interests of the noncontrolling owners. FAS 160 is
effective for fiscal years beginning on or after December 15,
2008. The Company has evaluated the impact of adoption of this
statement and concluded that it did not have an impact on the Company’s
financial position, results of operations, or cash flows for the first quarter
of fiscal 2009.
In March
2008, the FASB issued FAS No. 161, “Disclosures about Derivative Instruments and
Hedging Activities – an Amendment of FASB Statement No. 133.” The new standard
is intended to improve financial reporting about derivative instruments and
hedging activities by requiring enhanced disclosures to enable investors to
better understand their effects on an entity’s financial position, financial
performance, and cash flows. It is effective for financial statements issued for
fiscal years and interim periods beginning after November 15, 2008, with early
application encouraged. The Company has evaluated the impact of adoption of this
statement which did not have an impact on the Company’s financial position,
results of operations, or cash flows for the first quarter of fiscal
2009.
In
December 2007, the Emerging Issues Task Force (“EITF”) reached a consensus with
respect to Issue No. 07-1 “Accounting for Collaborative Arrangements”. This EITF
applies to participants in a collaborative arrangement. A collaborative
arrangement is a contractual arrangement that involves a joint operating
activity. These arrangements involve two (or more) parties who are both (a)
active participants in the activity and (b) exposed to significant risks and
rewards dependent on the commercial success of the activity. Many collaborative
arrangements involve licenses of intellectual property, and the participants may
exchange consideration related to the license at the inception of the
arrangement. Participants in a collaborative arrangement shall report costs
incurred and revenue generated from transactions with third parties (that is,
parties that do not participate in the arrangement) in each entity's respective
income statement pursuant to the guidance in EITF No. 99-19. An entity should
not apply the equity method of accounting under APB 18 to activities of
collaborative arrangements. This EITF, which can be applied retrospectively, is
effective for financial statements issued for fiscal years beginning after
December 15, 2008, and interim periods within those fiscal years. The Company
has evaluated the impact of adoption of this statement and concluded that it did
not have an impact on the Company’s financial position, results of operations,
or cash flows for the first quarter of fiscal 2009.
NOTE
3—LICENSE FEE PAYABLE:
In
February 2008, the Company entered into a sublicense agreement (the “Agreement”)
with Bio-Rad Laboratories, Inc. and Bio-Rad Pasteur (collectively,
“Bio-Rad”). Bio-Rad is the exclusive licensee of the HIV-2 patent
portfolio held by Institute Pasteur of Paris, France. Pursuant to the
terms of the Agreement, Bio-Rad sublicensed to the Company patents related to
the manufacture, use or sale of HIV-2 in the Company’s HIV screening
assays. In exchange for global non-exclusive rights to the patents,
the Agreement provides that the Company will pay Bio-Rad a $1,000,000 sublicense
fee, $500,000 payable during 2008, of which $125,000 has been paid and $375,000
was payable by December 31, 2008, with the additional $500,000 being payable by
December 31, 2009. On January 29, 2009, the Company and Bio-Rad
agreed to defer the remaining $875,000 of payments due under the HIV-2
sub-license originally granted by Bio-Rad to Chembio in February 2008 to one
payment due in December 2010. The Company will also pay Bio-Rad a
royalty on net sales in the United States and Canada, if any, of rapid test
immunoassay tests sold under the Company’s brands of Licensed Products as
defined in the Agreement. The Agreement will continue until the expiration of
the last-to-expire of the sublicensed patents, unless otherwise terminated at an
earlier date by the Company or Bio-Rad.
F-9
CHEMBIO DIAGNOSTICS, INC.
AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2009
(UNAUDITED)
NOTE 4—COMMITMENTS AND
CONTINGENCIES:
(a)
Economic Dependency:
The
following table delineates sales the Company had to customers in excess of 10%
of net sales for the periods indicated:
For
the three months ended
|
Accounts
Receivable
|
||||||||||||||||||||||
March
31, 2009
|
March
31, 2008
|
As
of
|
|||||||||||||||||||||
Sales
|
%
of Sales
|
Sales
|
%
of Sales
|
March
31, 2009
|
March
31, 2008
|
||||||||||||||||||
Customer
1
|
$ | 844,208 | 37 | $ | 540,836 | 24 | $ | 297,600 | $ | 317,455 | |||||||||||||
Customer
2
|
$ | 793,200 | 35 | * | * | $ | 119,737 | * | |||||||||||||||
Customer
3
|
$ | 370,278 | 16 | $ | 781,866 | 35 | $ | - | $ | 258,606 | |||||||||||||
Customer
4
|
* | * | $ | 272,045 | 12 | * | - |
In the
table above the asterisk (*) indicates that sales to the customer did not exceed
10% for the period indicated.
The
following table delineates purchases the Company made from vendors in excess of
10% of total purchases for the periods indicated:
For
the three months ended
|
Accounts
Payable
|
||||||||||||||||||||||
March
31, 2009
|
March
31, 2008
|
As
of
|
|||||||||||||||||||||
Purchases
|
%
of Purc.
|
Purchases
|
%
of Purc.
|
March
31, 2009
|
March
31, 2008
|
||||||||||||||||||
Vendor
1
|
$ | 125,062 | 25 | $ | 118,444 | 18 | $ | 1,778 | $ | 10,450 |
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. A change in suppliers,
however, could cause a delay in manufacturing and a possible loss of sales,
which would affect operating results adversely.
(b)
|
Governmental
Regulation:
|
All of
the Company’s existing and proposed diagnostic products are regulated by the
U.S. Food and Drug Administration, U.S. Department of Agriculture, certain 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 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.
F-10
CHEMBIO DIAGNOSTICS, INC.
AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2009
(UNAUDITED)
(c)
|
Nigeria
Algorithm:
|
During
the first quarter of 2008, the Nigerian Ministry of Health published a report
indicating that our designation in Nigeria as one of the screening tests would
be changed to that of a confirmatory and/or tie-breaker test (Many countries use
a serial algorithm with tests from different manufacturers. A serial
algorithm uses a screening test from one manufacturer, and if there is a
positive result from the screening test, a second confirmatory test, from
another manufacturer is used. As a result the number of confirmatory
tests used is equal to the positivity rate in the testing venue. A tie-breaker
test, from a third manufacturer, resolves discrepancies between the screen and
the confirmatory test). This change became effective in the first
quarter of 2009. Consequently ,our sales to Nigeria decreased
significantly in the first quarter of 2009 as compared to the first quarter of
2008 (see Note 2(f)). We anticipate that this trend will continue for
the remainder of the fiscal year.
(d)
|
Equipment
Purchase Commitment:
|
In
January of 2009, the Company entered into an agreement with an equipment
manufacturer to design and build equipment that will be used to automate the
assembling of our tests and lower our production costs. The estimated
cost of $323,500 is being paid in installments. As of March 31, 2009,
$150,000 has been paid and is reflected in deposits and other
assets.
NOTE
5—SUBSEQUENT EVENTS:
(a)
|
Operating
Lease for Facilities:
|
On
May 7, 2009, the Company entered into a new lease, beginning May 1, 2009, for
its administrative offices and research facilities, an 18,160 square foot space
located in Medford, NY. The principal terms of this lease are as
follows: (a) a lease term of five years; (b) an initial rent of
$11,350 per month; (c) the monthly rent for year two of the lease will
increase by the lower of (i) the change in the consumer price index, or
(ii) five percent; and (d) the monthly rent for years three through
five of the lease will increase each year by the lower of (i) the change in
the consumer price index, or (ii) two and one half percent.
(b)
|
Employee
Options:
|
On
May 7, 2009, the Compensation Committee of the Company reduced, to $0.13 per
share, the exercise price of each outstanding employee option that was issued
under the 1999 Equity Incentive Plan (the “1999 Plan”) for which the exercise
price was greater than $0.44 per share of the Company’s common
stock. The greater of 110% of the closing market price of the
Company’s common stock on May 7, 2009 or 110% of the volume weighted average
trading price for the 10 trading days ending May 7, 2009 rounded
to the nearest penny was used to determine the exercise price of
$.13 per share. There was no other change made to the terms of the
stock options other than the reduction in the exercise price.
In
addition, on May 7, 2009 in accordance with the terms of the Company’s 2008
Stock Incentive Plan, the Company granted certain employees of the Company,
options to purchase an aggregate of 2,925,000 shares of the Company’s common
stock. The exercise price for these options is equal to $0.13 per
share, which was the greater of 110% of the closing market price of the
Company’s common stock on May 7, 2009 or 110% of the volume weighted average
trading price for the 10 trading days ending May 7, 2009 rounded to the nearest
penny. The options become exercisable in thirds on the first, second
and third anniversaries of the date of the grant. Each option granted will
expire and terminate, if not exercised sooner, upon the earlier to occur of (a)
30 days after termination of the employee’s employment with the Company or (b)
the fifth anniversary of the date of grant.
(c)
|
Director
Compensation:
|
On
May 7, 2009, the Board of Directors of the Company revised the compensation of
non-employee directors to increase the number of options to be acquired every
five years from 180,000 to 375,000 options to purchase the Company’s common
stock. In addition the exercise price was changed from the closing
market price on the date of the grant to the greater of 110% of the closing
market price of the Company’s common stock on the date of grant or 110% of the
volume weighted average trading price for the 10 trading days ending on the date
of the grant.
To
accommodate the transition as of the June 3, 2009 annual meeting, any
non-employee director who is re-elected will receive the five-year allotment of
options and those options currently granted but not exercisable as of June 3,
2009 will be cancelled.
F-11
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
Overview
This
discussion and analysis should be read in conjunction with the accompanying
Condensed Consolidated Financial Statements and related notes. Our
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 accounting principles generally accepted in the United States.
The preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America 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 were 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,
2008.
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, is 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.
The
following management discussion and analysis relates to the business of the
Company, including its subsidiaries, which develop, manufacture, and market
rapid diagnostic tests that detect infectious diseases. The Company’s main
products presently commercially available are three rapid tests for the
detection of HIV antibodies in whole blood, serum and plasma samples, all of
which employ lateral flow technology and two of which were approved by the FDA
in 2006. In addition, we have a fourth rapid HIV test, more recently
developed on our patented Dual Path Platform (DPP®) technology, for the
detection of antibodies to HIV in oral fluid samples, as well as in whole blood,
serum and plasma samples. The products which employ lateral flow technology are
manufactured and sold under a non-exclusive license we
have from Inverness Medical Innovations, Inc. (“Inverness”), which is
also our exclusive marketing partner for
the FDA-approved products that are sold in the United
States (as well as Europe and Asia for the product that is known as the “barrel”
format product) under Inverness’ Clearview® brand. Inverness launched
its marketing of these products in the United States in February
2007. Chembio’s two HIV STAT-PAK® rapid HIV tests (in cassette and
dipstick formats) are marketed outside the United States through different
partners and channels under our license from Inverness.
Rapid HIV
tests represented nearly 70% of the Company’s product revenues in the quarter
ended March 31, 2009. The Company’s products are sold to medical laboratories
and hospitals, governmental and public health entities, non-governmental
organizations, medical professionals and retail establishments. Chembio’s
products are sold under the Company’s STAT PAK® or SURE CHECK ® registered
trademarks or under the private labels of its marketing partners, for example
the Clearview® label owned by Inverness Medical Innovations, Inc.
Research
and Development Activities
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. In 2008 the Company completed development of its first
two products that employ the DPP® technology and it has a number of additional
products under development that employ the DPP® technology. These
product development activities are further explained below.
During
the first quarter of 2009 and 2008, $647,000 and $626,000, respectively, were
spent on research and development activities. Substantially all of
our new product development activities involve employment of our Dual Path
Platform (DPP®) technology for which we were awarded a U.S. patent in
2007. We believe that this platform enables us to pursue many new
product development and licensing opportunities. The DPP® technology can provide
improved features on certain tests developed with it that include higher
sensitivity, earlier detection, improved performance with more challenging
sample types (such as oral fluid), and the improved ability to detect multiple
analytes (multiplexing) in one test device.
1
During
the first quarter of 2009 we continued developing a portfolio of products based
on the DPP® technology as are explained below.
o
|
DPP® Oral Fluid HIV Test -
During the first quarter we made further progress on but did not
finalize a term sheet with a large in vitro diagnostics marketing
organization concerning U.S. marketing rights to this product.
|
o
|
DPP® Syphilis Screen and
Confirm Test – Through the use of our DPP® technology, we have
developed the first point of care screen and confirm test that can detect
active syphilis cases. Given this progress, we are developing a plan for
commercialization of this product, including regulatory approval in the
U.S. and internationally
|
o
|
DPP® Agreements with Oswaldo
Cruz Foundation - We have now completed development of the
Leishmaniasis, HIV Confirmatory, and HIV oral fluid screening tests in
connection with the four agreements we signed with Oswaldo Cruz Foundation
in 2008. Based upon the results of testing, we anticipate
approval of the Leishmaniasis test by the Brazilian Ministry of
Agriculture, Livestock and Supply (MAPA) during the second quarter of
2009. Evaluations of the other two products are now in process
and we expect that all of these products will be approved by ANVISA for
distribution by FIOCRUZ in Brazil during 2009, generating initial orders
as well as approximately $1MM in technology transfer fee payments to the
Company in 2009, although there is no certainty that this will
occur. During the first quarter we shipped approximately
$400,000 of the Leishmaniasis product to
FIOCRUZ.
|
o
|
Other Research &
Development Activities -Chembio continues to work with commercial,
governmental and private organizations in order to obtain research grants
and other funding for development projects. In this regard, we
have entered into a development agreement with Bio-Rad, which, subject to
continued achievement of milestones and other conditions, could result in
approximately $200,000 of development funds for Chembio in
2009. We also have DPPÒ grants from
governmental agencies for $55,000 for leprosy research and $110,000 for
Human TB Serology research in 2009. In April we entered into a
Services Agreement with the Infectious Disease Research Institute to
develop DPP® products for Leishmaniasis and Leprosy for which we have
received $125,000 and which, subject to attainment of development
milestones, will additionally provide us with approximately $125,000
within the next twelve months. During the first quarter we
entered into a funded feasibility study agreement with the Foundation for
Innovative and Novel Diagnostics (FIND), a non-profit organization funded
by the Gates Foundation, related to development of serological tests for
Tuberculosis and Malaria using our DPP®. Subject to
achievement of additional milestones, additional funding will be provided
by FIND for this project. The CDC has issued a purchase order to Chembio
for a multiplex test related to pandemic influenza which, if the product
meets certain initial performance expectations, could result in a broader
funded collaboration with CDC in this field. We are also working on a new
product to enter the research animal testing
market.
|
There can
be no assurance that any of these projects will continue, meet regulatory or
other technical requirements and specifications, and/or that if continued, will
result in completed products, or that such products, if successfully completed,
will be successfully commercialized.
Regulatory
Activities
We
continue to make progress on obtaining a Community European (CE) marking for our
products to indicate conformity with European Union health, safety and
environmental requirements. We have submitted the HIV 1/2 STAT-PAK® technical
file to our notified body and should complete all required steps for CE Marking
of this product during the second quarter of 2009. Under
our agreement with Inverness we are to obtain a CE Marking for the Clearview®
Complete HIV 1/2. We are prepared to submit the technical file for
this product on behalf of Inverness once we have received final proposed
labeling from Inverness.
We are
pursuing registrations of our lateral flow and DPP® HIV products in a number of
other jurisdictions, and also pursing registrations with the USDA of additional
claims for our veterinary tuberculosis products.
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, accounting for complex financial
instruments and income taxes. For a summary of our significant accounting
policies, which have not changed from December 31, 2008, see our
annual report on Form 10-K for the period ended December 31, 2008, which was
filed with the SEC on March 18, 2009.
2
RESULTS
OF OPERATIONS FOR THE THREE MONTHS ENDED MARCH 31, 2009 AS COMPARED WITH THE
THREE MONTHS ENDED MARCH 31, 2008
Revenues:
Selected
Product Categories:
|
For
the three months ended
|
|||||||||||||||
March
31, 2009
|
March
31, 2008
|
$
Change
|
%
Change
|
|||||||||||||
HIV
|
$ | 1,596,795 | $ | 1,920,986 | $ | (324,191 | ) | -16.88 | % | |||||||
DPP
|
415,800 | - | 415,800 | n/a | ||||||||||||
Other
|
256,822 | 316,985 | (60,163 | ) | -18.98 | % | ||||||||||
Net
Product Sales
|
2,269,417 | 2,237,971 | 31,446 | 1.41 | % | |||||||||||
Research
grant income
|
276,181 | 126,757 | 149,424 | 117.88 | % | |||||||||||
Total
Revenues
|
$ | 2,545,598 | $ | 2,364,728 | $ | 180,870 | 7.65 | % |
Revenues
for our HIV tests during the three months ended March 31, 2009 decreased by
approximately $324,000 over the same period in 2008. This was
primarily attributable to decreased sales in Africa, primarily Nigeria, which
decreased in the first quarter of 2009 by approximately $820,000 compared to the
first quarter of 2008 (see Note 2(f) and Note 4(c)), which were partially offset
by increased sales to Inverness of our HIV products which increased by $304,000
to $844,000, and by sales to Brazil of $258,000. During the first
quarter of 2009 we had our first significant sales of product based on our DPP®
technology. The increase in grant and development income was due to
revenue generated from grant and feasibility studies that are related to
potential new products utilizing our patented DPP™ technology.
Gross
Margin:
Gross
Margin related to
|
For
the three months ended
|
|||||||||||||||
Net
Product Sales:
|
March
31, 2009
|
March
31, 2008
|
$
Change
|
%
Change
|
||||||||||||
Gross
Margin per Statement of Operations
|
$ | 998,690 | $ | 833,168 | $ | 165,522 | 19.87 | % | ||||||||
Less:
Research grant income
|
276,181 | 126,757 | 149,424 | 117.88 | % | |||||||||||
Gross
Margin from Net Product Sales
|
$ | 722,509 | $ | 706,411 | $ | 16,098 | 2.28 | % | ||||||||
Gross
Margin %
|
31.84 | % | 31.56 | % |
For the
year ended December 31, 2008, the Company reclassified its royalty and license
expenses to cost of goods sold. For all periods prior to December 31,
2008 these expenses were previously reflected in selling, general and
administrative expenses. Because we were not informed of the
agreement for the past royalties for the HIV-2 license between Inverness and
Bio-Rad until the quarter ended December 31, 2008, the quarterly reports for the
first three quarters of 2008 do not reflect this expense. If such an
expense was reflected in the three-month period ended March 31, 2008, the impact
of the past royalties would have been approximately $75,000 or
3.35%. This would have resulted in changes between the three-month
periods ended March 31, 2009 versus 2008 of approximately $91,000 and an
improved margin percentage of 3.63%. In addition, sales of our
Veterinary TB line of products in the quarter ended March 31, 2009 were
negligible but contributed approximately $72,000 to the gross margin in the
quarter ended March 31, 2008. Finally, an additional $31,000, or
1.37% of product sales, in expense was related to the termination of employees
during the three months ended March 31, 2009, which also reduced the gross
margin for the period ended in 2009.
3
Research and
Development:
This
category includes costs incurred for regulatory approvals, product evaluations
and registrations.
Selected
expense lines:
|
For
the three months ended
|
|||||||||||||||
March
31, 2009
|
March
31, 2008
|
$
Change
|
%
Change
|
|||||||||||||
Clinical &
Regulatory Affairs:
|
||||||||||||||||
Wages
and related costs
|
$ | 65,549 | $ | 66,836 | $ | (1,287 | ) | -1.93 | % | |||||||
Consulting
|
15,181 | 6,435 | 8,746 | 135.91 | % | |||||||||||
Clinical
Trials
|
1,780 | 74,180 | (72,400 | ) | -97.60 | % | ||||||||||
Other
|
7,260 | 21,241 | (13,981 | ) | -65.82 | % | ||||||||||
Total
Regulatory
|
$ | 89,770 | $ | 168,692 | $ | (78,922 | ) | -46.78 | % | |||||||
R&D Other than
Regulatory:
|
||||||||||||||||
Wages
and related costs
|
$ | 354,714 | $ | 279,786 | 74,928 | 26.78 | % | |||||||||
Consulting
|
17,432 | 5,000 | 12,432 | 248.64 | % | |||||||||||
Share-based
compensation
|
7,182 | 53,224 | (46,042 | ) | -86.51 | % | ||||||||||
Materials
and supplies
|
110,782 | 71,197 | 39,585 | 55.60 | % | |||||||||||
Other
|
67,492 | 48,437 | 19,055 | 39.34 | % | |||||||||||
Total
other than Regulatory
|
$ | 557,602 | $ | 457,644 | $ | 99,958 | 21.84 | % | ||||||||
Total
Research and Development
|
$ | 647,372 | $ | 626,336 | $ | 21,036 | 3.36 | % |
Expenses
for Clinical & Regulatory Affairs for the three months ended March 31,
2009 decreased by approximately $79,000 as compared to the same period in
2008. This was primarily due to clinical trial expenses in the first quarter of
2008 related to an amendment of our PMA claims to include the 12 -17 year old
age group.
Expenses
other than Clinical & Regulatory Affairs increased by approximately $100,000
in the three months ended March 31, 2009 as compared with the same period in
2008. These increases were primarily related to an increase in the
work related to feasibility studies for our DPP™ platform and to work
related to grant income received, both resulting in an increase in our personnel
and material costs, partially offset by the reduced cost of share-based
compensation related to the value of common stock and employee stock options
issued to employees.
Selling, General and
Administrative Expenses:
Selected
expense lines:
|
For
the three months ended
|
|||||||||||||||
March
31, 2009
|
March
31, 2008
|
$
Change
|
%
Change
|
|||||||||||||
Wages
and related costs
|
$ | 237,082 | $ | 350,235 | $ | (113,153 | ) | -32.31 | % | |||||||
Consulting
|
61,742 | 44,316 | 17,426 | 39.32 | % | |||||||||||
Commissons
|
83,963 | 27,450 | 56,513 | 205.88 | % | |||||||||||
Share-based
compensation
|
10,001 | 101,730 | (91,729 | ) | -90.17 | % | ||||||||||
Marketing
Materials
|
6,432 | 8,902 | (2,470 | ) | -27.75 | % | ||||||||||
Investor
Relations
|
3,039 | 59,080 | (56,041 | ) | -94.86 | % | ||||||||||
Legal,
Accounting and Sox 404 compliance
|
160,360 | 259,425 | (99,065 | ) | -38.19 | % | ||||||||||
Travel,
Entertainment and Trade Shows
|
16,947 | 20,919 | (3,972 | ) | -18.99 | % | ||||||||||
Bad
Debt Allowance
|
- | 6,062 | (6,062 | ) | -100.00 | % | ||||||||||
Other
|
96,247 | 140,281 | (44,034 | ) | -31.39 | % | ||||||||||
Total
S, G &A
|
$ | 675,813 | $ | 1,018,400 | $ | (342,587 | ) | -33.64 | % |
Selling,
general and administrative expenses for the three months ended March 31,
2009 decreased by 34% as compared with the same period in 2008. The
Company implemented a cost savings program during the first quarter of 2009 that
reduced personnel expenses, investor relations expenses, and professional fees,
along with a reduction in share-based compensation were partially offset by
increases in sales commissions that resulted from commissionable sales in Brazil
that increased in 2009 as compared with 2008. Our periodic review of
our allowance for doubtful accounts resulted in no change to the allowance in
the three months ended March 31, 2009.
4
Other Income and
Expense:
Other
Income and Expense
|
For
the three months ended
|
|||||||||||||||
March
31, 2009
|
March
31, 2008
|
$
Change
|
%
Change
|
|||||||||||||
Interest
income
|
$ | 3,384 | $ | 18,979 | $ | (15,595 | ) | -82.17 | % | |||||||
Interest
expense
|
(4,121 | ) | (5,593 | ) | 1,472 | -26.32 | % | |||||||||
Total
Other Income and Expense
|
$ | (737 | ) | $ | 13,386 | $ | (14,123 | ) | -105.51 | % |
Other
income for the three months ended March 31, 2009 decreased approximately $14,000
as compared with the same period in 2008 primarily as a result of a decrease in
interest income due to a decrease in available funds to invest in interest
bearing accounts.
LIQUIDITY
AND CAPITAL RESOURCES
For
the three months ended
|
||||||||||||||||
March
31, 2009
|
March
31, 2008
|
$
Change
|
%
Change
|
|||||||||||||
Net
cash provided by (used in) operating activities
|
$ | 235,867 | $ | (874,097 | ) | $ | 1,109,964 | -126.98 | % | |||||||
Net
cash used in investing activities
|
(151,241 | ) | (179,272 | ) | 28,031 | -15.64 | % | |||||||||
Net
cash utilized by financing activities
|
(4,458 | ) | (9,265 | ) | 4,807 | -51.88 | % | |||||||||
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
$ | 80,168 | $ | (1,062,634 | ) | $ | 1,142,802 | -107.54 | % |
The
Company had an increase in cash for the three months ended March 31, 2009 as
compared to a decrease in cash for the same period in 2008. The increase during
the 2009 and the decrease during the 2008 periods are primarily attributable to
the cash provided or used in operations.
The
Company had a working capital surplus of approximately $1,334,000 at March 31,
2009 and a working capital surplus of $1,664,000 at December 31,
2008. The Company estimates that its resources are sufficient to fund
its needs through the next twelve months or that, in the alternative, it could
raise additional capital although the terms under which that capital could be
raised would likely be very dilutive to current shareholders. The
Company’s liquidity and cash requirements will depend on several factors. These
factors include (1) the level of revenues; (2) the extent to which, if any, that
revenue level improves operating cash flows; (3) the Company’s investments in
research and development, facilities, marketing, regulatory approvals, and other
investments it may determine to make; and (4) the investment in capital
equipment (including production equipment of $323,500 that the Company has
contracted for) and the extent to which the Company improves cash flow through
operating efficiencies. There are no assurances that the Company will become
profitable or generate positive cash flow by the end of 2009 or, in the
alternative, be successful in raising sufficient capital to fund its needs
through March 31, 2010.
RECENT
DEVELOPMENTS AND CHEMBIO’S PLAN OF OPERATIONS FOR THE NEXT TWELVE
MONTHS
During
the first quarter of 2009 our net sales to Inverness increased more than
$300,000, or approximately 56%, as compared to the first quarter of
2008. These increased sales suggest to us that our sales to Inverness
will resume an upward trajectory in 2009 after we experienced a slight decrease
in sales to Inverness during 2008 as compared to our first year of sales to
Inverness in 2007. The actions that we took last year to expand the
regulatory claims of these products and provide the regulatory and technical
support to Inverness’ introductory marketing efforts are beginning to pay
off. These increases, together with a 117% increase in research and
development revenues and a 20% decrease in total operating expenses as compared
to the first quarter of 2008, enabled Chembio to reduce its operating loss in
the first quarter of 2009 by approximately 60%, or $487,000, as compared to the
first quarter of 2008.
Over the
next twelve months we expect to reflect improvements in our sales and operating
results due to continued increased sales to Inverness, as compared with the last
twelve months, increased sales from our DPP® technology (primarily as a result
of the contracts we signed with the Oswaldo Cruz Foundation in 2008), increased
revenues from research and development contracts, improved manufacturing
efficiencies, and decreased operating expenses. We believe that
we will be able to at least partially offset sales decreases to Nigeria with
opportunities we have in other markets.
Our
R&D efforts will be focused on our DPP® HIV 1/2 screening test for use with
oral fluids and our DPP® Syphilis Screen and Confirm test, in
addition to the DPP® products we anticipate launching in Brazil through the
Oswaldo Cruz Foundation, our contract development work for Bio-Rad Laboratories,
and several other research and development programs. During the first
quarter we made progress in finalizing a term sheet with a large in vitro
diagnostics marketing organization. If an agreement is completed, of
which there is no assurance, the agreement would fund all external regulatory
costs, would co-brand this product with our DPP® trademark, and would commit to
minimum sales volumes of the product in exchange for our granting them exclusive
U.S. marketing rights. We are also actively pursuing opportunities
for our oral fluid HIV test in the international markets that we already
participate in. We have completed development of our prototype DPP® Syphilis
Screen and Confirm Test, and we are developing a plan for commercialization of
this product including regulatory approval in the U.S., and we are very
encouraged by the interest we have received in this product. We
believe either or both of these products will begin to provide revenues this
year.
5
Equipment
Purchase Commitment:
In
January of 2009, the Company entered into an agreement with an equipment
manufacturer to design and build equipment that will be used to automate the
assembling of our tests and lower our production costs. The estimated
cost of $323,500 is being paid in installments. As of March 31, 2009,
$150,000 has been paid and is reflected in deposits and other
assets.
ITEM
4. CONTROLS AND PROCEDURES
(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 last fiscal quarter that have
materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
6
PART
II. OTHER INFORMATION
Item
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
To the
extent applicable, the contents of Item 5 below are incorporated into this Item
2 by reference
Item
5. OTHER INFORMATION.
Employee
options:
On May 7,
2009, the Compensation Committee of the Company reduced, to $0.13 per
share, the exercise price of each employee and option issued under the 1999
Equity Incentive Plan (the “1999 Plan”) for which the exercise price was greater
than $0.44 per share of the Company’s common stock. The greater of
110% of the closing market price of the Company’s common stock on May 7, 2009 or
110% of the volume weighted average trading price for the 10 trading days ending
May 7, 2009 rounded to the nearest penny was used to determine the exercise
price of $.13 per share. There was no other change made to the terms
of the stock options other than the reduction in the exercise
price.
The
following table lists the number of shares of Company common stock underlying
options with a previous exercise price greater than $0.44 per share that are
held by officers and the previous exercise price of each such stock
option.
Executive
Officer or Board Member
|
Number
of Shares of Common Stock Options under the 1999 Plan
|
Previous
Exercise Price
|
New
Exercise Price
|
|||
Javan
Esfandiari (1)
|
100,000
|
$0.48
|
$0.13
|
|||
Javan
Esfandiari (1)
|
100,000
|
$0.48
|
$0.13
|
|||
Javan
Esfandiari (1)
|
100,000
|
$0.48
|
$0.13
|
|||
Javan
Esfandiari (1)
|
18,750
|
$0.48
|
$0.13
|
|||
Javan
Esfandiari (1)
|
18,750
|
$0.48
|
$0.13
|
|||
Javan
Esfandiari (1)
|
30,000
|
$0.48
|
$0.13
|
|||
Javan
Esfandiari (1)
|
5,000
|
$0.48
|
$0.13
|
|||
Javan
Esfandiari (1)
|
25,000
|
$0.48
|
$0.13
|
|||
Javan
Esfandiari (1)
|
25,000
|
$0.48
|
$0.13
|
|||
Javan
Esfandiari (1)
|
25,000
|
$0.48
|
$0.13
|
|||
Javan
Esfandiari (1)
|
25,000
|
$0.48
|
$0.13
|
|||
Javan
Esfandiari (1)
|
25,000
|
$0.48
|
$0.13
|
|||
Lawrence
Siebert (2)
|
10,000
|
$0.48
|
$0.13
|
|||
Lawrence
Siebert (2)
|
50,000
|
$0.48
|
$0.13
|
|||
Lawrence
Siebert (2)
|
50,000
|
$0.48
|
$0.13
|
|||
Lawrence
Siebert (2)
|
50,000
|
$0.48
|
$0.13
|
|||
Richard
Bruce (3)
|
20,000
|
$0.48
|
$0.13
|
|||
Richard
Bruce (3)
|
12,500
|
$0.48
|
$0.13
|
|||
Richard
Bruce (3)
|
12,500
|
$0.48
|
$0.13
|
|||
Richard
Bruce (3)
|
12,500
|
$0.48
|
$0.13
|
|||
Richard
Bruce (3)
|
12,500
|
$0.48
|
$0.13
|
|||
Richard
Bruce (3)
|
10,000
|
$0.48
|
$0.13
|
|||
Richard
Bruce (3)
|
5,000
|
$0.48
|
$0.13
|
|||
Richard
J. Larkin (4)
|
18,750
|
$0.48
|
$0.13
|
|||
Richard
J. Larkin (4)
|
18,750
|
$0.48
|
$0.13
|
|||
Richard
J. Larkin (4)
|
50,000
|
$0.45
|
$0.13
|
|||
Richard
J. Larkin (4)
|
25,000
|
$0.48
|
$0.13
|
|||
Richard
J. Larkin (4)
|
25,000
|
$0.48
|
$0.13
|
|||
Tom
Ippolito (5)
|
15,000
|
$0.48
|
$0.13
|
(1)
Javan Esfandiari is Senior Vice President of Research and Development for
the Company.
|
||||||
(2)
Lawrence A. Siebert is the Company’s Chief Executive Officer and a
Director.
|
||||||
(3)
Richard Bruce is Vice President of Operations for the
Company.
|
||||||
(4)
Richard J. Larkin is the Company’s Chief Financial
Officer.
|
||||||
5)
Tom Ippolito is Vice President of Regulatory Affairs, QA & QC for the
Company.
|
7
In
addition, on May 7, 2009 in accordance with the terms of the Company’s 2008
Stock Incentive Plan, the Company granted certain employees of the Company
options to purchase an aggregate of 2,925,000 shares of the Company’s common
stock. The exercise price for these options is equal to $0.13 per
share, which was the greater of 110% of the closing market price of the
Company’s common stock on May 7, 2009 or 110% of the volume weighted average
trading price for the 10 trading days ending May 7, 2009 rounded to the nearest
penny. The options become exercisable in thirds on the first, second
and third anniversaries of the date of the grant. Each option granted will
expire and terminate, if not exercised sooner, upon the earlier to occur of (a)
30 days after termination of the employee’s employment with the Company or (b)
the fifth anniversary of the date of grant. The following table identifies
the portions of these options issued to officers of the Company.
Name
of Executive Officer
|
Number
of Shares of Common Stock Options
|
Exercise
Price of Stock Option
|
Expiration
Date of Stock Option
|
Vesting
Date of Stock Option
|
|||||||
Javan
Esfandiari – Senior Vice President of Research and
Development
|
100,000
|
|
$0.13
|
5/7/2014
|
5/7/2010
|
||||||
100,000
|
|
$0.13
|
5/7/2014
|
5/7/2011
|
|||||||
100,000
|
|
$0.13
|
5/7/2014
|
5/7/2012
|
|||||||
Lawrence
A. Siebert - Chief Executive Officer
|
133,333
|
|
$0.13
|
5/7/2014
|
5/7/2010
|
||||||
133,333
|
|
$0.13
|
5/7/2014
|
5/7/2011
|
|||||||
133,334
|
|
$0.13
|
5/7/2014
|
5/7/2012
|
|||||||
Richard
Bruce - Vice President of Operations
|
75,000
|
|
$0.13
|
5/7/2014
|
5/7/2010
|
||||||
75,000
|
|
$0.13
|
5/7/2014
|
5/7/2011
|
|||||||
75,000
|
|
$0.13
|
5/7/2014
|
5/7/2012
|
|||||||
Richard
J. Larkin – Chief Financial Officer
|
91,666
|
|
$0.13
|
5/7/2014
|
5/7/2010
|
||||||
91,667
|
|
$0.13
|
5/7/2014
|
5/7/2011
|
|||||||
91,667
|
|
$0.13
|
5/7/2014
|
5/7/2012
|
|||||||
Tom
Ippolito - Vice President of Regulatory Affairs, QA &
QC
|
75,000
|
|
$0.13
|
5/7/2014
|
5/7/2010
|
||||||
75,000
|
|
$0.13
|
5/7/2014
|
5/7/2011
|
|||||||
75,000
|
|
$0.13
|
5/7/2014
|
5/7/2012
|
These
issuances were granted based on exemptions from registration under the
Securities Act of 1933, as amended (the “Securities Act”), and applicable state
laws pursuant to Section 4(2) of the Securities Act and Rule 506 of Regulation
D. These issuances qualified for this exemption from registration
because (i) the Company did not engage in any general solicitation or
advertising to market the securities; (ii) all the Company's reports filed
under the Securities Exchange Act of 1934 were made available to the recipients;
(iii) each recipient was provided the opportunity to ask questions and
receive answers from the Company regarding the offering; (iv) the
securities were issued to persons with knowledge and experience in financial and
business matters so that he or she is capable of evaluating the merits and risks
of an investment in the Company; and (v) the recipients received
“restricted securities” that include a restrictive legend on the
certificate.
Director
Compensation:
On May 7,
2009, the Board of Directors of the Company revised the compensation of
non-employee directors to increase the number of stock options to be granted
every five years from 180,000 to 375,000 options to purchase the Company’s
common stock. In addition, the exercise price was changed from the
closing market price on the date of the grant to the greater of 110% of the
closing market price of the Company’s common stock on the date of grant or 110%
of the volume weighted average trading price for the 10 trading days ending on
the date of the grant. The new director compensation is now as
follows:
All
non-employee directors are paid an $18,000 annual retainer, payable
semi-annually, and in addition once every five years stock options to acquire
375,000 shares of the Company's common stock, with an exercise price equal to
the greater of 110% of the closing market price of the Company’s common stock on
the date of grant or 110% of the volume weighted average trading price for the
10 trading days ending on the date of the grant. With respect to this
stock option grant, stock options to acquire 75,000 shares become exercisable on
the date of grant, and options to acquire an additional 75,000 shares become
exercisable on the date of each of the four succeeding annual meetings of
stockholders if and to the extent that the non-employee director is reelected as
a director at each such annual meeting. If in any
year the Company does not hold an annual meeting of stockholders within 30 days
after the anniversary date for the current year of the original stock option
grant, then the options that are scheduled to become exercisable in that current
year shall become exercisable on the 30th day
after such anniversary date. If a person becomes a member of
the Board at a time other than at an annual meeting, then that person is granted
options to purchase that number of shares of common stock that is the same
percentage of 75,000 that the number of days remaining until the one-year
anniversary of the most recent annual meeting of stockholders is of
365. The audit committee chairman is paid an annual retainer of
$2,500, paid semi-annually. In addition, the non-employee directors
are paid $1,000 in cash for each board of directors meeting attended in person,
and paid $500 in cash for each telephonic board of directors meeting exceeding
20 minutes in which they participate. The non-employee directors who
are members of a committee of the board of directors are paid $500 in cash for
each committee meeting exceeding 20 minutes in which they participate in person
or by telephone or, in the case of the chairperson of the committee, $750 in
cash for each committee meeting attended exceeding 20 minutes in which they
participate in person or by telephone.
To
accommodate the transition as of the June 3, 2009 annual meeting, any
non-employee director who is re-elected will receive the five-year allotment of
options and those options currently granted but not exercisable as of June 3,
2009 will be cancelled.
8
Item
6. EXHIBITS.
Number
|
Description
|
3.1
|
Articles
of Incorporation, as amended. (3)
|
3.2
|
Amended
and Restated Bylaws. (1)
|
4.1
|
Registration
Rights Agreement, dated as of May 5, 2004, by and among the Registrant and
the Purchasers listed therein. (2)
|
4.2
|
Form
of $0.90 Warrant issued to Mark L. Baum pursuant to the Consulting
Agreement dated as of May 5, 2004 between the Registrant and Mark L. Baum.
(2)
|
4.3
|
Form
of $0.60 Warrant issued to Mark L. Baum pursuant to the Consulting
Agreement dated as of May 5, 2004 between the Registrant and Mark L. Baum.
(2)
|
4.4
|
Form
of Common Stock Warrant issued pursuant to the January 26, 2005 Securities
Purchase Agreement. (8)
|
4.5
|
Amended
Form of Common Stock Warrant issued pursuant to the January 26, 2005
Securities Purchase Agreement. (10)
|
4.6
|
Registration
Rights Agreement, dated as of January 26, 2005, by and among the
Registrant and the purchasers listed therein. (8)
|
4.7
|
Form
of Warrant, dated June 29, 2006, issued pursuant to Company and purchasers
of the Company’s Secured Debentures. (4)
|
4.8
|
Registration
Rights Agreement, dated June 29, 2006. (4)
|
4.9
|
Registration
Rights Agreement, dated as of September 29, 2006, by and among the
Registrant and the Purchasers listed therein. (6)
|
4.10
|
Form
of Common Stock Warrant issued pursuant to the Securities Purchase
Agreements dated September 29, 2006 (6).
|
4.11
|
Amended
Form of Common Stock Warrant issued pursuant to the Securities Purchase
Agreements dated October 5, 2006. (10)
|
4.12
|
Amended
Form of Common Stock Warrant issued to Placement Agents pursuant to the
October 5, 2005 Securities Purchase Agreement. (10)
|
4.13*
|
Form
of Employee Option Agreement. (10)
|
4.14
|
Amended
Form of Warrant used for Consultant Services, and in connection with the
Company’s 2004 merger. (10)
|
4.15
|
1999
Equity Incentive Plan (12)
|
4.16
|
2008 Stock Incentive Plan. (13)
|
10.1*
|
Employment
Agreement dated June 15, 2006 with Lawrence A. Siebert.
(5)
|
10.2*
|
Employment
Agreement dated April 23, 2007 with Javan Esfandiari.
(11)
|
10.3
|
Series
A Convertible Preferred Stock and Warrant Purchase Agreement (the “Stock
and Warrant Purchase Agreement”), dated as of May 5, 2004, by and among
the Registrant and the purchasers listed therein. (2)
|
10.4
|
Securities
Purchase Agreement (the “Securities Purchase Agreement”), dated as of
January 26, 2005, by and among the Registrant and the purchasers listed
therein. (8)
|
10.5
|
Amendment
No. 1 to Securities Purchase Agreement, dated as of January 28, 2005 by
and among the Registrant and the purchasers listed therein.
(9)
|
10.6
|
Security
Purchase Agreement, dated June 29, 2006, among the Company and purchasers
of the Company’s Secured Debentures. (4)
|
10.7
|
Securities
Purchase Agreement (the “Securities Purchase Agreement”), dated as of
September 29, 2006, by and among the Registrant and the Purchasers listed
therein. (6)
|
10.8
|
Letter
of Amendment to Securities Purchase Agreements dated as of September 29,
2006 by and among the Registrant and the Purchasers listed therein.
(6)
|
10.9
|
HIV
Barrel License, Marketing and Distribution Agreement, dated as of
September 29, 2006, by and among the Registrant, Inverness and StatSure.
(6)
|
10.10
|
HIV
Cassette License, Marketing and Distribution Agreement, dated as of
September 29, 2006, between the Registrant and Inverness.
(6)
|
10.11
|
Non-Exclusive
License, Marketing and Distribution Agreement, dated as of September 29,
2006, between the Registrant and Inverness. (6)
|
10.12
|
Joint
HIV Barrel Product Commercialization Agreement, dated as of September 29,
2006, between the Registrant and StatSure. (6)
|
10.13
|
License
and Supply Agreement dated as of August 30, 2002 by and between Chembio
Diagnostic Systems Inc. and Adaltis Inc. (7)
|
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.
|
(1)
|
Incorporated
by reference to the Registrant’s registration statement on Form SB-2 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.
|
(2)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed with the
Commission on May 14, 2004.
|
(3)
|
Incorporated
by reference to the Registrant’s annual report on Form 10-KSB filed with
the Commission on March 31, 2005.
|
(4)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed with the
Commission on July 3, 2006.
|
(5)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed with the
Commission on June 21, 2006.
|
(6)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed with the
Commission on October 5, 2006.
|
(7)
|
Incorporated
by reference to the Registrant’s registration statement on Form SB-2 filed
with the Commission on June 7,
2004.
|
(8)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed with the
Commission on January 31, 2005.
|
(9)
|
Incorporated
by reference to the Registrant’s registration statement on Form SB-2 filed
with the Commission on March 28,
2005.
|
(10)
|
Incorporated
by reference to the Registrant’s annual report on Form 10-KSB filed with
the Commission on March 12, 2008.
|
(11)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K/A filed with
the Commission on May 3, 2007.
|
(12)
|
Incorporated
by reference to the Registrant’s definitive proxy statement on Schedule
14A filed with the Commission on May 11,
2005.
|
(13)
|
Incorporated
by reference to the Registrant’s definitive proxy statement on Schedule
14A filed with the Commission on April 14,
2008.
|
(*)
|
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.
|
9
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:
|
May
7, 2009
|
By:
/s/ Lawrence A.
Siebert
|
Lawrence
A. Siebert
|
||
Chief
Executive Officer
(Principal
Executive Officer)
|
||
Date:
|
May
7, 2009
|
By:
/s / Richard J.
Larkin
|
Richard
J. Larkin
|
||
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
|
10