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): August 9, 2007 (August 9,
2007)
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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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
To
the
extent applicable, the information disclosed under Item 7.01 and Exhibit
99.1 is incorporated herein by reference.
ITEM
7.01. Regulation FD Disclosures
On
August
9, 2007, the Company issued the press release titled “Chembio Reports Second
Quarter Financial Results” included herein as Exhibit 99.1.
On
July
31, 2007, the Company issued the press release titled “Chembio and Pall
Corporation Enter DPP™ Collaboration” included herein as Exhibit
99.2.
ITEM
9.01. Financial Statements and Exhibits
Exhibits.
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99.1
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Press
Release titled “Chembio
Reports Second Quarter Financial
Results” issued
August 9, 2007.
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99.2
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Press
Release titled “Chembio
and Pall Corporation Enter DPP™
Collaboration”
issued July 31, 2007.
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In
accordance with General Instruction B.2 of Form 8-K, the information disclosed
in Items 2.02 and 7.01 of, and Exhibits 99.1 and 99.2 attached to, this Current
Report on Form 8-K shall not be deemed “filed” for the purpose of Section 18 of
the Securities Exchange Act of 1934, nor shall it be deemed incorporated by
reference in any filing. This Current Report on Form 8-K does not
constitute a determination of whether any information included herein is
material.
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: August 9,
2007 Chembio
Diagnostics, Inc.
By: /s/
Lawrence A.
Siebert
Lawrence A. Siebert
Chief Executive Officer
Chembio
Reports Second Quarter Financial Results
Conference
Call Scheduled for August 14 at 4:30 PM EDT
MEDFORD,
N.Y (August 9, 2007) – Chembio Diagnostics, Inc. (OTC/BB: CEMI) today
reported financial results for the three and six months ended June 30,
2007.
Revenues
for the second quarter of 2007 were $2.50 million, a 53% increase compared
with
revenues for the second quarter of 2006 of $1.64 million. The second
quarter 2007 net loss attributable to common stockholders was $0.98 million,
or
$0.08 per share, compared with the second quarter 2006 net loss attributable
to
common stockholders of $1.34 million, or $0.13 per share. The net losses
attributable to common stockholders for the second quarter of 2007 and 2006
are
net of $0.36 million and $0.21 million, respectively, related to dividends
on
the Company’s convertible preferred stock, of which $0.30 million and $0.21
million, respectively, were non-cash dividends paid.
Revenues
for the first six months of 2007 were $4.54 million, a 58% increase compared
with revenues for the first six months of 2006 of $2.87 million. The
net loss attributable to common stockholders for the first half of 2007 was
$2.07 million, or $0.17 per share, compared with the net loss attributable
to
common stockholders for the first half of 2006 of $3.28 million, or $0.34
per
share. The net losses attributable to common stockholders for the first six
months of 2007 and 2006 are net of $0.71 million and $0.88 million,
respectively, related to dividends on the Company’s convertible preferred stock
as well as the beneficial conversion feature, of which $0.65 million and
$0.74
million were non-cash dividends paid.
Growth
in
revenues during the second quarter and first six months of 2007 was attributable
to higher sales of the Company's rapid HIV products, which increased 143%
and
178%, respectively, compared with the prior-year periods. Sales
include the launch of two of the Company’s three HIV tests in the U.S. in
February 2007 by Inverness Medical Innovations.
Gross
margin for the second quarter 2007 increased to $0.99 million or 40% of total
revenues, compared with gross margin of $0.56 million or 34% of total revenues
for the second quarter of 2006. Gross margin on product sales for the
second quarter 2007 increased to $0.91 million or 38%, compared with gross
margin on product sales of $0.50 million or 32% for the second quarter of
2006. The second quarter 2007 loss from operations decreased to $0.65
million, compared with $1.12 million for the second quarter of
2006.
Gross
margin for the first six months of 2007 increased to $1.65 million or 36%
of
total revenues, compared with gross margin of $1.00 million or 35% of total
revenue for the first six months of 2006. Gross margin on product
sales for the first six months of 2007 increased to $1.56 million or 35%,
compared with gross margin on product sales of $0.87 million or 32% for the
first six months of 2006. The first six months of 2007 loss from
operations decreased to $1.57 million, compared with $2.38 million for the
first
six months of 2006.
Several
important milestones affecting the Company were achieved during the second
quarter of 2007, including:
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·
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Grant
of license to Chembio from the United States Department of Agriculture
to
manufacture and market Chembio’s initial rapid test for veterinary
application
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·
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Launch
of Prima-TB STAT PAK™, the Company’s rapid lateral flow diagnostic test
for the detection of antibodies to active pulmonary tuberculosis
in
non-human primates
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·
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Completion
of the inspection for ISO 13.485, resulting in a recommendation
that the
Company be certified
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·
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Agreement
with the Partnership for Supply Chain Management System, the consortium
authorized under the President’s Emergency Plan for AIDS Relief to
centralize certain procurements, logistics and
forecasting
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·
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Agreement
with the Infectious Disease Research Institute (IDRI) for the development
of rapid tests for leishmaniasis and leprosy on Chembio’s Dual Path
Platform (DPP™), utilizing IDRI’s proprietary
antigens
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·
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Progress
in negotiations with third parties for the licensing, development
and
manufacturing of a number of products incorporating
DPP
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Retention
of a Senior Vice President of Commercial Operations to lead Chembio’s
business development activities with respect to its patented DPP
technology
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·
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Agreement
among Chembio, Inverness Medical Innovations and StatSure Diagnostics
to
extend the carve-out, until at least September 2008, for Chembio’s direct
sales of its SURE CHECK HIV 1/2 to Chembio’s distributor in Mexico, a
subsidiary of Bio-Rad Laboratories,
Inc.
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·
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Completion
of improvements to Chembio’s HIV barrel product that should allow for CLIA
waiver of this product
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Lawrence
Siebert, chairman and president of Chembio, commented, “We are pleased with our
progress during the second quarter, as we achieved strong revenue growth,
improved our gross margins and controlled our operating expenses. We
believe that the combination of increased sales from the higher-margin HIV
and
veterinary TB rapid tests being marketed in the U.S., together with the contract
development and license revenues we anticipate from our DPP business-development
efforts, should bring us closer to profitability in the periods
ahead.”
CONFERENCE
CALL
The
Company has scheduled a conference call and web-cast for 4:30 p.m. Eastern
Daylight time on Tuesday August 14, 2007. Participants may access the
call by dialing (877) 407-9205 in the U.S. or (201) 689-8054 outside the
U.S.
The conference call may also be accessed via the internet in the
Investor Center section of www.chembio.com.
ABOUT
CHEMBIO
Chembio
Diagnostics, Inc. is a developer and manufacturer of rapid diagnostic tests
for
infectious diseases. The Company has received marketing approval from the
FDA
for two of its rapid HIV tests. The Company also manufactures rapid tests
for
veterinary tuberculosis and Chagas disease, and has developed a patent-pending
technology, the Dual Path Platform (DPP™), for its next-generation HIV and other
rapid tests. References to Chembio may also include its wholly-owned operating
subsidiary, Chembio Diagnostic Systems, Inc. For additional information please
visit www.chembio.com.
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 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
for its products 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.
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Chembio
Diagnostics, Inc.
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Summary
of Results of Operations
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For
the three months ended
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For
the six months ended
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June
30, 2007
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June
30, 2006
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June
30, 2007
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June
30, 2006
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Total
Revenues
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$ |
2,502,773
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$ |
1,637,236
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$ |
4,541,093
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$ |
2,874,903
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Gross
Profit
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991,900
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564,434
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1,651,718
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999,973
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Operating
Loss
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(654,597 | ) | (1,120,352 | ) | (1,565,735 | ) | (2,375,266 | ) | ||||||||
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Net
Loss
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(625,856 | ) | (1,127,375 | ) | (1,354,662 | ) | (2,391,090 | ) | ||||||||
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Preferred
Dividends
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356,900
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207,937
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710,878
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884,294
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Net
Loss Attributable to Common Stockholders
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$ | (982,756 | ) | $ | (1,335,312 | ) | $ | (2,065,540 | ) | $ | (3,275,384 | ) | ||||
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Loss
per share
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$ | (0.08 | ) | $ | (0.13 | ) | $ | (0.17 | ) | $ | (0.34 | ) | ||||
Contacts:
Company
Contact: Investor
Relations Contacts:
Chembio
Diagnostics,
Inc. Lippert/Heilshorn
& Associates, Inc.
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Matty
Arce
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Anne
Marie Fields
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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
Chembio
and Pall Corporation Enter DPP™ Collaboration
New
York,
July 31, 2007- (OTCBB: CEMI) – Chembio Diagnostic, Inc. (OTC BB: CEMI.OB – News)
announced today it has signed an initial research and development collaboration
with Pall Corporation employing Chembio’s new Dual Path Platform (DPP™). Pall
Corporation has a number of potential applications for DPP™ although the initial
collaboration will be focused on the feasibility of one such
application. Pall selected DPP™ because of its unique functional
design that could facilitate high levels of analyte detection
capability.
The
Dual
Path Platform immunoassay is a next generation lateral flow technology that
employs separate membrane strips for sample migration and test reagents.
The
DPP™ immunoassay design allows for complete control and management of the sample
flow, and as a result the immunological reaction is much more efficient than
conventional single path lateral flow (SPLF) tests. These key technological
features enable the DPP™ immunoassay to demonstrate improved detectability,
sensitivity and specificity when compared with SPLF tests.
The
collaborative agreement with Pall is a two-phase funded feasibility study
that
will help ascertain certain performance characteristics of DPP™ when used in
conjunction with certain markers that are of interest to Pall. If
performance meets or exceeds certain levels, Chembio anticipates that the
parties would proceed to negotiation of license, development and manufacturing
agreements related to these and potentially other markers.
According
to Chembio Chief Executive Officer, Larry Siebert, “We are very proud and
excited to be working with Pall Corporation as we look to bring our DPP™
technology to commercialization in a wide variety of applications.” Chembio
Senior Vice President of Commercial Operations Bob Aromando further commented,
“Our collaboration with Pall is a major milestone achievement for us, and
is
further confirmation of the clear advantages of DPP™.”
ABOUT
CHEMBIO
Chembio
Diagnostics, Inc., a developer and manufacturer of rapid diagnostic tests
for
infectious diseases. The Company has received marketing approval from the
FDA
for two of its rapid HIV tests. The Company also manufactures rapid tests
for
both human and veterinary Tuberculosis and Chagas Disease, and has developed
a
patent-pending technology, the Dual Path Platform (DPP™), for its next
generation HIV and other rapid tests. For additional information please visit
www.chembio.com.
ABOUT
PALL CORPORATION
For
additional information please visit www.pall.com.
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.
Contact:
Matty
Arce - 631-924-1135 ext 123.