SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
Date
of
Report (Date of earliest event reported) January
9, 2006
CHEMBIO
DIAGNOSTIC, 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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3661
Horseblock Road
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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
2.02. Results of Operations and Financial Condition.
| (a) |
To
the extent applicable, the information disclosed under Item 7.01 is
incorporated herein by reference.
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ITEM
7.01. Regulation FD Disclosures.
| (a) |
On
January 9, 2006 the Registrant issued the press release titled “Chembio
Announces Preliminary Revenue for the Fourth Quarter and Full Year
2005”
included herein as Exhibit 99.1.
|
ITEM
9.01. Financial Statements and Exhibits
(c) 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:
January 10, 2006 Chembio
Diagnostics, Inc.
By: /s/
Lawrence A. Siebert
Lawrence
A. Siebert
Chief
Executive Officer
Exhibit
99.1
CHEMBIO
ANNOUNCES
PRELIMINARY REVENUE FOR THE FOURTH QUARTER AND FULL YEAR
2005
Preliminary
2005 HIV Test Revenues Increase approximately
93%; Preliminary Fourth Quarter HIV Test Revenues Increase approximately
63%
MEDFORD,
N.Y. - January 9, 2006 - Chembio Diagnostics Inc. (OTCBB:CEMI) announced
today
that, based on preliminary data, it expects to report revenue of approximately
$3.93 million for the full year 2005 and $1.33 million for the fourth quarter
of
2005. This reflects an increase of approximately 19% compared to the $3.31
million reported for the 2004 year and an increase of approximately 15% compared
to $1.16 million reported for the fourth quarter of 2004.
This
quarterly and annual revenue growth was primarily driven by increased sales
of
the Company’s rapid HIV tests. Rapid HIV test revenue for the full year 2005
increased approximately 93% to approximately $2.40 million as compared to
$1.24
million in 2004 and fourth quarter rapid HIV test revenue increased
approximately 63% to approximately $1.22 million compared to $.75 million
reported for the fourth quarter of 2004 as based upon this preliminary review.
The large increase in rapid HIV test revenue well outpaced decreased revenue
of
approximately $.44 million from the Company’s pregnancy tests which Chembio
de-emphasized in 2004 as part of its strategy to focus on more proprietary
rapid
diagnostic tests.
“During
2005 we made significant progress in our business strategy and achieved several
important milestones,” commented Lawrence Siebert, Chembio’s President. “We are
beginning to see the results from aligning ourselves with the President’s $15
billion Emergency Plan for AIDS Relief, multi-lateral programs affiliated
with
the United Nations such as the UNAIDS ‘3 by 5’ initiative, and other significant
programs that are aimed at combating AIDS, which we believe can only be achieved
by a massive scale-up of rapid testing. We have established local offices
in
Tanzania and Nigeria to participate in these programs and to create sustainable
and supportable business in these markets. We are also actively looking at
opportunities for establishing marketing, distribution and local assembly
programs for our rapid HIV tests with partners in Asia and South America,
in
addition to our ongoing contract in Brazil.”
Mr.
Siebert continued, “We anticipate FDA approval for two of our rapid HIV tests in
2006 that will enable us to participate in the U.S. market as well. We also
believe that our Chagas disease rapid test will produce meaningful revenue
early
in 2006, and that we will also receive USDA approval for at least one of
our
veterinary tuberculosis tests in 2006.”
ABOUT
CHEMBIO
Chembio
Diagnostics, Inc. (Chembio) possesses expertise in the development and
manufacturing of rapid test products for various infectious diseases, including
HIV, Tuberculosis and Chagas Disease. References to Chembio Diagnostics,
Inc.
may actually refer to Chembio Diagnostic Systems, Inc.; the 100%-owned
subsidiary of Chembio Diagnostics, Inc. Chembio is located at 3661 Horseblock
Road, Medford, NY 11763.
FORWARD-LOOKING
STATEMENTS
Statements
contained herein that are not historical facts may be forward-looking statements
within the meaning of the Securities Act of 1933, as amended. Forward-looking
statements include statements regarding the intent, belief or current
expectations of the Company and its management and statements concerning
the
Company’s preliminary estimates for the periods ended December 31, 2005
discussed herein. Such statements are estimates only, as the Company has
not
completed the preparation of its financial statements for those periods,
nor has
its auditor completed the audit of those results. Actual revenue may differ
materially from those anticipated in this press release. Such statements
reflect
management's current views, are based on certain assumptions and involve
risks
and uncertainties. Actual results, events, or performance may differ materially
from the above forward-looking statements due to a number of important factors,
and will be dependent upon a variety of factors, including, but not limited
to
Chembio's ability to obtain additional financing, to obtain regulatory approvals
in a timely manner, and the demand for Chembio's products. Chembio undertakes
no
obligation to publicly update these forward-looking statements to reflect
events
or circumstances that occur after the date hereof or to reflect any change
in
Chembio's expectations with regard to these forward-looking statements or
the
occurrence of unanticipated events. Factors that may impact Chembio's success
are more fully disclosed in Chembio's most recent public filings with the
U.S.
Securities and Exchange Commission.
Contact:
Vince
Daniels/James Carbonara
The
Investor Relations Group
212-825-3210