Chembio Diagnostics Inc (CEMI)

[Hegotgame]

Chembio Diagnostics Reports First Quarter 2012 Financial Results
Record
Product Sales More Than Double Over Prior Year; Conference Call Begins at 10:00
a.m. Eastern Time Today


MEDFORD, NY, May 08, 2012 (MARKETWIRE via COMTEX) -- Chembio Diagnostics, Inc.
(OTCQB: CEMI) (PINKSHEETS: CEMI), a leader in point-of-care diagnostic tests for
infectious diseases, today reported financial results for the three months ended
March 31, 2012.

Financial highlights for the first quarter of 2012 include the following (all
comparisons are with the first quarter of 2011):





-- Total revenues of $6.65 million, up 83% compared with $3.64 million

-- Product sales of $6.36 million, up 111% compared with $3.02 million

-- Operating income of $720,000, compared with an operating loss of

$139,000

-- Net income of $433,000 or $0.01 per diluted share, compared with a net

loss of $142,000 or $0.00 per diluted share



Commenting on the Company's strong quarterly performance, Lawrence Siebert,
Chembio's Chief Executive Officer, said, "2012 has gotten off to a very strong
start with record product sales more than doubling compared with the prior year.
These gains were led by increased purchase orders from the Oswaldo Cruz
Foundation (FIOCRUZ), our license and technology transfer partner in Brazil, and
from continued strong demand for our rapid HIV tests in the U.S. We remain
confident about the financial outlook for 2012, which we believe will include
record revenues and operating income.

"We were pleased to complete enrollment in our 3,000-patient clinical trial for
our DPP(R) HIV 1/2 Assay in mid-April. This important and versatile product is a
rapid point-of-care test for the detection of antibodies to HIV 1 and 2 in oral
fluid, finger-stick whole blood, venous whole blood, serum or plasma. The test
provides a simple 'reactive/non-reactive' result intended to be used in the
preliminary diagnosis of patients with HIV in point-of-care settings such as
public health and other clinics, hospital emergency rooms and physician offices.
We have previously filed the first two modules of our Pre-Marketing Approval
(PMA) application with the U.S. Food and Drug Administration (FDA) and expect to
file the third and final module by the end of the second quarter. We have
confidence that this product will meet the required performance on all sample
matrices.

"With more than 1.1 million Americans estimated to be living with HIV and
approximately 20% of them unaware they are infected with the virus, rapid HIV
tests are playing a critical role in the U.S., as they have globally, to help
identify those with HIV and to prevent disease transmission. Pending FDA
approval, our DPP HIV 1/2 assay test, with its ability to test oral fluids,
should provide a significant market opportunity for Chembio in the coming years
and gives us an opportunity to brand our DPP product line in the U.S.

"We look forward to continued growth of our DPP product line in Brazil by
FIOCRUZ and expect this collaboration to drive revenue growth throughout 2012,"
concluded Mr. Siebert.

First Quarter Results

Total revenues for the first quarter of 2012 were $6.65 million, up 83% compared
with total revenues of $3.64 million for the first quarter of 2011. Product
sales increased 111% to $6.36 million from $3.02 million in the prior-year
period, and exceeded product sales for the first six months of 2011 by $374,000.
Research and development (R&D), milestone, grant and royalty revenues for the
first quarter of 2012 decreased to $290,000 from $621,000 in the same period of
2011.

Gross profit increased 73% to $3.3 million in the 2012 first quarter compared
with $1.93 million in the 2011 first quarter due to higher product revenue and
changes in product mix, partially offset by lower R&D, licensing and royalty
revenues. Product gross profit for the first quarter of 2012 increased 133% to
$3.04 million, compared with $1.31 million for the comparable period in 2011.

R&D expenses were $1.38 million in the first quarter of 2012 and $1.29 million
in the prior year. The 2012 first quarter included $191,000 of clinical trial
expenses which were incurred in 2011 and were not invoiced until April of 2012.

For the three months ended March 31, 2012, selling, general and administrative
expenses increased to $1.23 million from $775,000 in the prior year, largely due
to higher commissions on DPP product sales to Brazil, as well as to higher wages
and stock-based compensation.

Operating income for the first quarter of 2012 was $720,000, compared with an
operating loss of $139,000 for the first quarter of 2011.

Net income for the first quarter of 2012 was $433,000 or $0.01 per diluted
share, compared with a net loss of $142,000 or $0.00 per share for the
comparable period in 2011. The 2012 first quarter net income included $285,000
in income tax provision, which reflects approximately the amount of income taxes
that would be attributable to the Company's profit for the quarter if the
Company did not have an operating loss carryforward to offset income taxes
payable.

Balance Sheet Highlights

The Company had cash of $2.95 million as of March 31, 2012, compared with $3.01
million as of December 31, 2011.

Conference Call

Chembio has scheduled a conference call and webcast for 10:00 a.m. Eastern time
today. To participate on the call, please dial [phone] from the U.S. or
[phone] from outside the U.S. In addition, following the completion of
the call, a telephone replay will be accessible until March 15, 2012 at 11:59
p.m. Eastern time by dialing [phone] from the U.S. or [phone] from
outside the U.S. and entering reservation account number 286 and conference ID
#: 393134. The conference call may also be accessed via the internet at
http://www.investorcalendar.com/IC/CEPage.asp?ID=167559. 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. develops, manufactures, licenses and markets
proprietary rapid diagnostic tests in the growing point-of-care testing market.
Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the
U.S. by Alere North America, Inc. Chembio markets its HIV STAT-PAK(R) line of
rapid HIV tests internationally to government and donor-funded programs directly
and through distributors. Chembio has developed a patented point-of-care test
platform technology, the Dual Path Platform (DPP(R)) technology, which has
significant advantages over 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(R). Headquartered in
Medford, NY, with approximately 160 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. For more
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 are
estimates only, as the Company has not completed the preparation of its
financial statements for those periods, nor has its auditor completed a review
or 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.







Chembio Diagnostics, Inc. & Subsidiary

Summary of Condensed Consoldidated Results of Operations



For the three months ended

---------------------------

March 31, March 31,

2012 2011

------------- -------------

Net product sales $ 6,363,152 $ 3,015,063



License and royalty revenue - 28,854



R&D, milestone and grant revenue 290,100 591,764

------------- -------------



TOTAL REVENUES $ 6,653,252 $ 3,635,681



GROSS MARGIN $ 3,332,864 $ 1,926,342



Research and development expenses $ 1,379,131 $ 1,290,142



Selling, general and administrative expenses $ 1,233,968 $ 775,371



INCOME (LOSS) FROM OPERATIONS $ 719,765 $ (139,171)



Income tax provision $ 285,400 $ -



NET INCOME (LOSS) $ 433,443 $ (142,297)



Basic net income per share $ 0.01 $ (0.00)



Diluted net income per share $ 0.01 $ (0.00)



Weighted average number of shares outstanding,

basic 63,474,580 62,284,772



Weighted average number of shares outstanding,

diluted 68,098,858 62,284,772







Chembio Diagnostics, Inc. & Subsidiary

Summary of Condensed Consolidated Balance Sheets



March 31, December 31,

2012 2011

------------- -------------



CURRENT ASSETS:

Cash and cash equivalents $ 2,954,276 $ 3,010,954

Accounts receivable, net of allowance for

doubtful accounts of $125,000 and $30,000 for

2012 and 2011, respectively 3,616,720 2,998,449

Inventories 2,706,676 2,300,286

Prepaid expenses and other current assets 755,082 681,893

------------- -------------

TOTAL CURRENT ASSETS 10,032,754 8,991,582



FIXED ASSETS, net of accumulated depreciation 1,118,989 1,062,276



OTHER ASSETS

Deferred tax asset, net of valuation allowance 4,492,763 4,749,622

License agreements and other assets 715,290 682,264

------------- -------------



$ 16,359,796 $ 15,485,744

============= =============



TOTAL CURRENT LIABILITIES $ 3,133,399 $ 2,857,626



TOTAL OTHER LIABILITIES 120,937 133,484

------------- -------------



TOTAL LIABILITIES 3,254,336 2,991,110



TOTAL STOCKHOLDERS' EQUITY 13,105,460 12,494,634

------------- -------------



$ 16,359,796 $ 15,485,744

============= =============







Chembio Diagnostics, Inc. & Subsidiary

Summary of Condensed Consolidated Cash Flow



For the three months ended

----------------------------

March 31, March 31,

2012 2011

------------- -------------



Net cash provided by operating activities $ 149,226 $ 1,560,142

Net cash used in investing activities (223,716) (46,358)

Net cash provided by (used in) financing

activities 17,812 (853,032)

------------- -------------

(DECREASE) INCREASE IN CASH AND CASH

EQUIVALENTS $ (56,678) $ 660,752

============= =============










Contacts:

Chembio Diagnostics

Susan Norcott

[phone], ext. 125

[e-mail]



LHA

Anne Marie Fields

[phone]

[e-mail]

@LHA_IR_PR





SOURCE: Chembio Diagnostics, Inc.




CONTACT: mailto:[e-mail]

mailto:[e-mail]




Copyright 2012 Marketwire, Inc., All rights reserved.

-0-




SUBJECT CODE: Medical and Healthcare:Healthcare

Medical and Healthcare:Alternative

Medical and Healthcare:Medical Devices

Pharmaceuticals and Biotech:Trials

Pharmaceuticals and Biotech:Biotech

Pharmaceuticals and Biotech:Drugs

Pharmaceuticals and Biotech:Equipment and Supplies

Medical and Healthcare:Surgery and Treatments