SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K/A
Amendment
No. 1
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
Date of
Report (Date of earliest event reported): July 9, 2008 (June 2,
2008)
CHEMBIO
DIAGNOSTICS, INC.
(Exact
name of registrant as specified in its charter)
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Nevada
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0-30379
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88-0425691
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(State
or other jurisdiction
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(Commission
File Number)
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(IRS
Employer
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of
Incorporation)
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Identification
Number)
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|||
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3661
Horseblock Road
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||||
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Medford,
NY 11763
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(Address
of principal executive offices)
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631-924-1135
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(Registrant’s
Telephone Number)
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N/A
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM
7.01. REGULATION
FD DISCLOSURE.
On June
2, 2008 the Company filed a Current Report on Form 8-K with the SEC that
included an investor fact sheet (the "June Fact Sheet"). The June Fact Sheet
included a typographical error regarding the Company's operating loss in 2006
and 2007, which the Company had indicated was $2,017,000 and $3,862,000,
respectively. The Company has corrected this error in the revised
investor fact sheet attached hereto as exhibit 99.1 to indicate that the
Company's operating loss in 2006 and 2007 was $4,580,000 and $2,876,000,
respectively.
The
information in this Item 7.01 of this Form 8-K is being furnished and shall not
be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act
of 1934, or otherwise subject to the liabilities of that section. The
information in this Item 7.01 of this Form 8-K also shall not be deemed to be
incorporated by reference into any filing under the Securities Act of 1933, as
amended, or the Securities Exchange Act of 1934, except to the extent that the
Company specifically incorporates it by reference.
ITEM
9.01. FINANCIAL STATEMENTS AND EXHIBITS
Exhibits.
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.
Date: July
9,
2008 Chembio
Diagnostics, Inc.
By: /s/ Lawrence A.
Siebert
Lawrence
A. Siebert
Chief
Executive Officer
Exhibit
Index
Please see PDF
of this exhibit ex99_2.pdf
Chembio
Diagnostics, Inc.
3661
Horseblock Road, Medford, NY 11763
Ticker
Symbol: CEMI (OTCBB)
Year
Founded: 1992
Number
of Employees: 96
Company
Contact: Susan Norcott 631-924-1135 x125
www.chembio.com
Business
Description
Chembio
Diagnostics, Inc. develops, manufactures and licenses point-of-care testing
(POCT) products. Chembio created and patented a new revolutionary
technology called Dual Path Platform (DPP™). The technology is addressing
critical market requirements in the infectious disease testing market and other
growing markets. Products under development, both OEM and branded,
are anticipated to create significant new revenue streams that will add to
Chembio’s core business of rapid HIV tests.
Investment
Highlights
Newly
patented DPP technology revolutionizes the category showing significant
improvement over earlier technology. Major benefits include improved
sensitivity, multiplexing, sample control and quantitative
measurements.
Chembio’s
FDA Approved HIV tests marketed in U.S. by Inverness Medical Innovation (IMA), a
leading POCT company. IMA markets Chembio’s products as Clearview®
Complete HIV 1/2 globally and Clearview® HIV 1/2 STAT-PAK™
in U.S. to hospital emergency departments, public health clinics, and physicians
offices.
Point
of care testing is the fastest growing segment of the $28 billion
in-vitro diagnostics market. Drive for cost containment and need for quick
results have caused the market to grow rapidly.
Financial
Information
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(in
$000's)
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QI 2008
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QI 2007
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2007
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2006
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||||||||||||
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Total
Revenues
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$ | 2,365 | $ | 2,038 | $ | 9,231 | $ | 6,503 | ||||||||
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Cost
of Sales
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1,303 | 1,378 | 5,369 | 4,486 | ||||||||||||
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Gross
Profit
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1,062 | 660 | 3,862 | 2,017 | ||||||||||||
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Gross
Profit %
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-44.90 | % | -32.38 | % | -41.84 | % | -31.02 | % | ||||||||
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Overhead
Costs:
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||||||||||||||||
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R&D
with Regulatory
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626 | 319 | 1,907 | 1,401 | ||||||||||||
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S,
G&A
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1,248 | 1,252 | 4,831 | 5,196 | ||||||||||||
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Total
Overhead Costs
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1,874 | 1,571 | 6,738 | 6,597 | ||||||||||||
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Operating
Income (Loss)
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(812 | ) | (911 | ) | (2,876 | ) | (4,580 | ) | ||||||||
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Net
Income (Loss)
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(798 | ) | (729 | ) | (2,627 | ) | (4,995 | ) | ||||||||
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Pref.
Divid. & Beneficial Conv. Features
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- | 354 | 5,645 | 3,210 | ||||||||||||
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Net
Loss Attrib. To Common Stockholders
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$ | (798 | ) | $ | (1,083 | ) | $ | (8,272 | ) | $ | (8,205 | ) | ||||
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Selected
Balance Sheet Information ($000s)
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QI
2008
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|||
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Cash
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1,765 | |||
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Total
Assets
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6,615 | |||
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Total
Liabilities
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2,992 | |||
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Shareholders’
Equity
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3,624 | |||
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Common
Stock Outstanding
(#
Shares in 000s)
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60,537 | |||
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Stock
Information
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Price
5/19/08
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52
wk. hi/lo
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$0.12
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$.65
/ $.08
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Market
Cap
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$7.2MM
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Average
Vol.
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100,477
(3 Mos.)
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Company
Coverage / Analyst
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Collins
Stewart LLC
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Keay
Nakae
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JM
Dutton Assoc,
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Stephen
Handley
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Major
Beneficial Holders
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#
of Common Shares and Warrants
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Crestview
Capital Masters Fund, LLC
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24,145,310
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Lawrence
Siebert
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8,466,405
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Inverness
Medical Innovations, Inc.
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5,367,840
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Vicis
Capital Master Fund
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4,608,707
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Millennium
3 Opportunity Fund, LLC
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4,006,610
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[graphs of revenue and gross profit - not shown - see PDF]
[images of Inverness sell sheet - not shown - - see PDF]
DPP™
Technology
Competitive
Advantages For POC Testing
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•
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Improved Sensitivity -
enabled by more efficient binding
method
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•
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Easier
Multiplexing - due to even and direct distribution of
sample to multiple test lines
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•
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Enhanced Sample Control
– as a result of independent sample migration
path
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•
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Clearer Results –
efficient binding allows for improved functionality of instruments for
reading and reporting of qualitative or quantitative
results
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Management
Team
Lawrence A. Siebert, CEO, 25
years of management and financing experience
Richard J. Larkin, CFO, 25
years of operational and financial experience
Javan Esfandiari, SVP R&D,
15 years of experience in development of in-vitro diagnostic point of
care products
Robert Aromando, SVP Commercial,
25 years of sales and marketing experience in diagnostics and
pharmaceutical industries
Board
Of Directors
Katherine Davis - Former
Lieutenant Governor and numerous other leadership positions for the State
of Indiana; former senior executive of Cummins, Inc.
(NYSE:CMI)
James Merselis - 30 years of
Dx industry experience; Former CEO of Hemosense (AMEX:HEM) sold in 2007 to
Inverness
Dr. Gary Meller - broad
experience in medical and information technology and pharmaceutical product
development
Alan Carus, CPA – former
partner of Ernst & Young and senior executive with Overseas Shipholding
Group, Inc. (NYSE:OSG)
Except
for the historical information contained herein, the matters discussed in this
document are forward-looking statements, the accuracy of which is subject to
risks and uncertainties. Please refer to Chembio Diagnostic’s Inc. most recent
Form 10-KSB and Forms 10-Q for additional information about the Company and
related risks. - May 2008