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): March 13, 2008 (March 11,
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
March
11, 2008, Chembio Diagnostics, Inc. (the “Company”) issued a press release
entitled “Chembio to Host Conference Call to Discuss Fourth Quarter and Full
Year 2007 Financial Results.” A copy of the press release is furnished herewith
as Exhibit 99.1.
On
March 13, 2008, the Company also issued a press release entitled “Chembio
Reports Fourth Quarter and Full-Year 2007 Results.” A copy of the press release
is furnished herewith as Exhibit 99.2.
All
of 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
Exhibit 99.1
– Press Release entitled “Chembio to Host Conference Call to Discuss Fourth
Quarter and Full Year 2007 Financial Results” dated March 11,
2008.
Exhibit 99.2
– Press Release entitled “Chembio Reports Fourth Quarter and Full-Year 2007
Results.” dated March 13, 2008.
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: March
13,
2008 CHEMBIO
DIAGNOSTICS, INC.
By: /s/
Lawrence A. Siebert
Lawrence
A. Siebert
Chief
Executive Officer
Exhibit
99.1
Chembio
to Host Conference Call to Discuss Fourth Quarter and Full Year 2007 Financial
Results
MEDFORD,
N.Y. (March 11, 2008)– Chembio Diagnostics, Inc. (OTCBB:
CEMI) Chembio Diagnostics, Inc., a developer and
manufacturer of rapid diagnostic tests for infectious diseases, announced
today
that the company will release financial results for the fourth quarter and
full
year ended December 31, 2007, following the close of the market on Wednesday,
March 12, 2007.
Lawrence
A. Siebert, Chembio’s president and chief executive officer, will host an
investment community conference call beginning at 10:00 a.m. Eastern Time
on
Thursday, March 13, 2008 to discuss these results and to answer
questions.
To
participate, please dial (877) 407-0782 from the U.S. or (201) 689-8567 from
outside the U.S. In addition, following the completion of the call, a
telephone replay will be accessible until March 20, 2008 at 11:59 p.m. Eastern
Time by dialing (877) 660-6865 from the U.S. or (201) 612-7415 from outside
the
U.S. and entering reservation account number 286 and conference ID
278362.
Those
interested in listening to the conference call live via the Internet may
do so
by visiting the Investor Relations section of Chembio’s web site at
www.chembio.com. To listen to the live call, please go to the Web
site 15 minutes prior to its start to register, download, and install the
necessary audio software. A replay will be available on the Web site
for a limited time.
ABOUT
CHEMBIO DIAGNOSTICS
Chembio
Diagnostics, Inc., a developer and manufacturer of proprietary rapid diagnostic
tests, participates in the growing $5 billion point-of-care testing market.
Chembio’s two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the
U.S. by Inverness Medical Innovations, Inc. Chembio markets its HIV
STAT-PAK® line of rapid HIV tests internationally to government and donor-funded
programs directly and through distributors. Chembio also has rapid
tests for veterinary tuberculosis and Chagas disease. In 2007, Chembio
received a U.S. patent for its Dual Path Platform (DPP™) technology which has
significant advantages over currently available lateral-flow
technologies. This technology is providing Chembio with a significant
pipeline of business opportunities for the development and manufacture of
new
products based on DPP™. Headquartered in Medford, N.Y., with
approximately 100 employees, Chembio is licensed by the U.S. Food and Drug
Administration (FDA) as well as the U.S. Department of Agriculture (USDA),
and
is certified for the global market under the International Standards
Organization (ISO) directive 13.485.
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. 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.
Contacts:
Company
Contact: Investor
Relations Contacts:
Chembio
Diagnostics,
Inc.
Lippert/Heilshorn & Associates, Inc.
Matty
Arce
Anne Marie Fields (afields@lhai.com)
(631)
924-1135, ext.
123 (212)
838-3777
www.chembio.com
Bruce Voss (bvoss@lhai.com)
(310) 691-7100
# # #
Exhibit
99.2
Chembio
Reports Fourth Quarter
and
Full-Year 2007 Results
Results
Feature Record Revenues for Point-of-Care, Rapid HIV
Tests
Conference
Call Scheduled for Thursday, March 13 at 10:00 a.m. Eastern
Time
MEDFORD,
N.Y (March 13, 2008) – Chembio Diagnostics, Inc. (OTC/BB: CEMI)
today reported financial results for the three and twelve months ended December
31, 2007.
Total
revenues for 2007 were $9.2 million, an increase of $2.7 million or 42% from
total revenues of $6.5 million in 2006. This increase was primarily
due to initial sales of Chembio’s rapid HIV tests to its U.S. marketing partner,
increased sales in Africa, sales to a distributor in Mexico, and increased
development and grant revenues, partially offset by lower sales to South
America.
Rapid
HIV
test revenue for 2007 increased $3.5 million to $7.9 million or 79% from $4.4
million in 2006. This includes approximately $2.4 million in revenues
realized from sales of rapid HIV tests in the United States.
The
net
loss attributable to common stockholders was $8.3 million or $0.57 per share
for
2007 compared to a net loss attributable to common stockholders of $8.2 million
or $0.80 per share for 2006. The net loss attributable to common stockholders
for 2007 includes $4.2 million of non-recurring deemed dividends and $1.3
million in non-cash dividends to preferred stockholders. The net loss
attributable to common stockholders for 2006 includes $3.0 million in non-cash
dividends to preferred stockholders. As previously reported, all of
the Company’s preferred stock was converted to common stock on December 19,
2007, and no preferred stock dividends are required in the future.
Total
revenues for the fourth quarter of 2007 were $2.4 million, a 9% decrease
compared with fourth quarter 2006 revenues of $2.6 million. This
decrease was primarily due to $1.1 million of revenues from a division of
Bio-Rad Laboratories in Mexico and $845,000 in sales to Brazil during the 2006
fourth quarter that did not recur in the 2007 fourth quarter. These
items were largely offset by increased rapid HIV test sales in Africa of
$740,000, and to sales by the Company’s marketing partner in the U.S. of
$875,000 during the 2007 quarter, where there were no sales in the 2006
quarter.
The
net
loss attributable to common stockholders was $5.2 million or $0.32 per share
for
the fourth quarter of 2007 compared to a net loss attributable to common
stockholders of $3.1 million or $0.24 per share for the fourth quarter of 2006.
The net loss attributable to common stockholders for the fourth quarter of
2007
includes $4.2 million of non-recurring deemed dividends and $.25 million in
non-cash dividends to preferred stockholders. The net loss
attributable to common stockholders for the fourth quarter of 2006 included
$1.0
million in non-cash dividends to preferred stockholders.
Fourth
Quarter and Recent Highlights
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•
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Received
CLIA (Clinical Laboratory Improvement Act) Waiver for our FDA-approved
HIV
Barrel test, a unique, self-contained rapid HIV test that is exclusively
marketed worldwide by Inverness Medical Innovations, Inc. as Clearview®
COMPLETE HIV 1/2. The CLIA waiver allows the sale of these rapid
HIV tests
to a potential market of approximately 189,000 laboratory entities
across
the United States, including physician offices and
clinics.
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|
•
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Achieved
the performance objectives of the feasibility study for the Company’s Dual
Path Platform (DPP™”) point-of-care test system entered into with Pall
Corporation in July 2007. This successful feasibility study demonstrated
the significant performance advantages of DPP™ over conventional
single-path lateral-flow design and further defined the value proposition
that the technology can provide to
partners.
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•
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Completed
three new technology transfer, supply and license agreements with
The
Bio-Manguinhos unit of the Oswaldo Cruz Foundation of Brazil for
products
being developed by Chembio with its patented DPP™ technology. Internal and
external studies demonstrated high sensitivity and specificity for
Chembio’s DPP™ assays for Leishmania, Leptospirosis and HIV-1 confirmatory
tests in comparison with conventional single-path, lateral-flow technology
in screening for infectious diseases. This agreement also served
to
advance the scale-up of DPP™ production capability for future DPP™
collaborations.
|
|
•
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Engaged
in funded feasibility studies for DPP technology with potential
partners.
|
|
•
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Received
certification under ISO (International Organization for Standardization)
13.485: 2003, the quality system that is most recognized throughout
the
European Community for products seeking a CE marking. Chembio has
engaged
a European Notified Body in connection with its plans to obtain a
CE
marking for its products.
|
“We
are
pleased with our many achievements in 2007. We significantly
increased our revenues, expanded our gross margins, controlled our overhead
costs, advanced our proprietary DPP™ technology and enhanced our production
capacity. We expect to build upon this momentum throughout 2008,"
said Lawrence Siebert, President and CEO. "Our 2007 revenue growth is largely
attributable to our entry into the U.S. market. The recent CLIA
waiver mentioned above significantly expands the market for this point-of-care
diagnostic. In addition, recent recommendations by the U.S. Center
for Disease Control and Prevention (CDC) for routine HIV screening of the
general population are expected to continue to drive sales of rapid,
point-of-care HIV diagnostics.”
“During
2007, we made great strides toward advancing our proprietary DPP™
technology. We engaged in a number of feasibility agreements for
DPP™, and are optimistic about its future. Our agreements with the
Oswaldo Cruz Foundation and agreements in negotiations with others are
validating DPP™ and laying the ground work for future DPP™ collaborations,"
continued Mr. Siebert.
In
closing, he stated, "The recent conversion of our outstanding preferred shares
to common stock has simplified our capital structure in a manner that we believe
will benefit out Company and our shareholders. We would like to thank our loyal
and supportive shareholders for the confidence that they have expressed in
Chembio during this past year and our employees for their dedication and hard
work."
Conference
Call
Chembio
has scheduled a conference call and webcast for 10:00 a.m. Eastern time on
Thursday, March 13, 2008. Participants may access the call by dialing
(877) 407-0782 in the U.S. or (201) 689-8567 outside the
U.S. Following the completion of the call, a telephone replay will be
accessible until March 20, 2008 at 11:59 p.m. Eastern Time by dialing (877)
660-6865 from the U.S. or (201) 612-7415 from outside the U.S. and entering
reservation account number 286 and conference ID 278362. The conference call
may
also be accessed via the internet at
http://www.vcall.com/IC/CEPage.asp?ID=127084. An archive of the
webcast will be available for 90 days on the Company's website at
www.chembio.com.
About
Chembio Diagnostics
Chembio
Diagnostics, Inc., a developer and manufacturer of proprietary rapid diagnostic
tests, participates in the growing $5 billion point-of-care testing market.
Chembio’s two U.S. Food and Drug Administration (FDA) PMA-approved, CLIA-waived,
rapid HIV tests are marketed in the U.S. by Inverness Medical Innovations,
Inc. Chembio markets its HIV STAT-PAK® line of rapid HIV tests
internationally to government and donor-funded programs directly and through
distributors. Chembio also has rapid tests for veterinary
tuberculosis and Chagas disease. In 2007 Chembio received a U.S. patent
for its Dual Path Platform (DPP™) technology which has significant advantages
over currently available lateral-flow technologies. This technology
is providing Chembio with a significant pipeline of business opportunities
for
the development and manufacture of new products based on
DPP™. Headquartered in Medford, N.Y. with approximately 100
employees, Chembio is licensed by the FDA as well as the U.S. Department of
Agriculture (USDA), and is certified for the global market under the
International Standards Organization (ISO) directive 13.485.
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. 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.
Contacts:
Company
Contact: Investor
Relations Contacts:
Chembio
Diagnostics,
Inc.
Lippert/Heilshorn & Associates, Inc.
Matty
Arce
Anne
Marie Fields
631-924-1135
ext
123 (afields@lhai.com)
www.chembio.com
(212) 838-3777
Bruce Voss
(bvoss@lhai.com)
(310) 691-7100
www.lhai.com
(Tables
to follow)
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Chembio
Diagnostics, Inc.
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Summary
of Results of Operations
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For
the years ended
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||||||||
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December
31, 2007
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December
31, 2006
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|||||||
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Total
Revenues
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$ |
9,230,948
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$ |
6,502,480
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||||
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|
||||||||
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Gross
Profit
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3,862,303
|
2,016,568
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||||||
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||||||||
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Operating
Loss
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(2,876,164 | ) | (4,580,193 | ) | ||||
|
|
||||||||
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Net
Loss
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(2,626,892 | ) | (4,995,020 | ) | ||||
|
|
||||||||
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Preferred
Dividends, Deemed Dividends and Beneficial Conversion
Feature
|
5,645,310
|
3,210,046
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||||||
|
|
||||||||
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Net
Loss Attributable to Common Stockholders
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$ | (8,272,202 | ) | $ | (8,205,066 | ) | ||
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||||||||
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Loss
per share
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$ | (0.57 | ) | $ | (0.80 | ) | ||
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Chembio
Diagnostics, Inc.
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||||||||
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Summary
of Balance Sheet
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||||||||
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December
31, 2007
|
December
31, 2006
|
||||||
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CURRENT
ASSETS:
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||||||||
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Cash
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$ |
2,827,369
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$ |
4,290,386
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||||
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Other
current assets
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2,643,938
|
2,663,282
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||||||
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TOTAL
CURRENT ASSETS
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5,471,307
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6,953,668
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||||||
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NET
FIXED ASSETS
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829,332
|
603,603
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||||||
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OTHER
ASSETS
|
284,358
|
349,306
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||||||
|
|
$ |
6,584,997
|
$ |
7,906,577
|
||||
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TOTAL
CURRENT LIABILITIES
|
$ |
2,242,583
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$ |
1,840,435
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||||
|
|
||||||||
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TOTAL
OTHER LIABILITIES
|
79,588
|
456,758
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||||||
|
|
||||||||
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TOTAL
LIABILITIES
|
2,322,171
|
2,297,193
|
||||||
|
|
||||||||
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PREFERRED
STOCK -Series C
|
-
|
6,549,191
|
||||||
|
|
||||||||
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TOTAL
STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
4,262,826
|
(939,807 | ) | |||||
|
|
||||||||
|
|
$ |
6,584,997
|
$ |
7,906,577
|
||||
# # #