RAPID Tests for EARLIER Treatment
Investor Presentation
Slide 2
Forward Looking Statements
Statements contained herein that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of Chembio 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 develop, manufacture, market and finance new products 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. Other 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.
Slide 3
Investment Highlights
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Develops, Manufactures & Markets Point-of-care (POC) Diagnostic Tests, a $10 Billion Market
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Partnered with Leading License & Distribution Partners in U.S. & South America
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Oral Fluid HIV Test Pending FDA Approval
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Pipeline Includes Syphilis, Hepatitis-C, HIV Self-Test & Potential Multiplex POC Testing Products
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Successive Record Revenues & Income in 2009-2011 & Anticipated in 2012
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Seasoned Management Team, Strengthened in Q3 2012
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Slide 4
POCT’s – A Growing Global Market
Converting Lab Tests to POC and Creating New Markets
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Rapid HIV Test Markets -$200MM Globally
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Oral Fluid HIV Test Pending FDA Approval
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HIV OTC (Self-testing) Market Estimated at >$250MM - Uniquely Positioned
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Other New POCT Markets Targeted by Chembio
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Hepatitis-C POCT Market
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R&D, Initial External Studies Completed
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DPP® Syphilis Screen & Confirm Tests in EU and Brazil; U.S. Clinical Studies
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See Graphic
Slide 5
Chembio Has Achieved Strong Growth in its FDA-Approved Lateral Flow HIV Tests Sold Globally
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Significant Growth & Increased Market Share in US Market Through Collaboration with Alere (NYSE: ALR)
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Opportunities to Grow Participation in International Markets via PEPFAR, Global Fund
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See Graphics
Slide 6
SURE CHECK® HIV & Development of the Over-the-Counter (OTC) Market For Self-Testing
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10 Years Later, New POCT OTC Market Launch by Competitor in Q4 2012
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Chembio Uniquely Positioned to Capitalize on Competitor’s Market Development Investment
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Chembio Product Already FDA-Approved & Distributed in US (Alere) and International Professional Market
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Pursuing FDA IDE to Begin OTC Studies in 2013, FDA Submissions 2014-2015
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See Graphics
Slide 7
Chembio’s Patented Technology: Dual Path Platform (DPP®)
A Patented Platform Technology with a Multitude of Potential Diagnostic Applications
Improves Performance (Sensitivity and Specificity) v. Lateral Flow
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Features Independent Sample Path and Direct Binding
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Enables Improved Multiplex Products
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MULTIPLEX DPP® HIV Confirmatory Test Launched by Chembio in Brazil; Licensed to
Bio-Rad Worldwide
Foundational DPP Patent issued in U.S.; Additional patents issued or pending in U.S. & many foreign jurisdictions
See Graphics
Slide 8
Successful Launch of DPP Products in Brazil
Oswaldo Cruz Foundation (FIOCRUZ)
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$4.3MM Revenues in 2011
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>$9MM Anticipated in 2012
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Possible New Products and Private Market Collaborations in Brazil
See Graphics
Slide 9
DPP HIV Oral Fluid & Blood Rapid Test Pending FDA Approval
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Completed 3,000 Patient Clinical Trial Q2
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Filed Final Module with FDA in June 2012
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PMA Approval Anticipated by End of 2012
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CLIA Waiver/Launch 2013
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Potential OTC Trials & FDA Submission 2014-2016
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See Graphic
Slide 10
Pipeline: DPP® Syphilis Screen & Confirm Test
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First Dual POCT for Syphilis Enables Confirmation & Treatment At POC
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CE Marked October 2011, International Distribution being Established
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Pursuing US 510(K) Regulatory Clearance via De Novo Application
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HIV-Syphilis Combo Test
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Developed in collaboration with the U.S. Centers for Disease Control
Slide 11
Pipeline: Rapid Hepatitis C Point-of-Care Diagnostic
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Data Published in Journal of Clinical Virology shows Chembio's assay to be superior in assessing Hepatitis C among high-risk participants
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Recent CDC draft guidelines recommend HCV screening for all Americans born between 1945 and 1965—an estimated 70 million Americans
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Commence optimization studies of the assay 2H 2012
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Opportunity for strategic partnerships
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See Graphic
Slide 12
Selected Financial Data FY2008 - 2011
See Graphics
Slide 13
Chembio Selected Financial Results Through Six Month Ended June 30, 2012
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1st Half 2012 Revenues Increased 75% to $12.7MM Compared to 1st half 2011
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$1.23 Operating Income Achieved with Strong DPP-Brazil and US Market Gains
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In (000’s)
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YTD June 30, 2012
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YTD June 30, 2011
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Net Product Revenues
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$12,174
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$ 5,989
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Non-Product Revenues
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$ 563
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$ 1,260
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TOTAL REVENUES
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$12,737
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$ 7,249
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GROSS MARGIN
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$5,904
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46%
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$3,977
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55%
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OPERATING COSTS:
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Research and Development exp
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$ 2,358
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19%
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$2,455
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34%
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Selling, G&Administrative exp
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$2,313
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18%
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$1,464
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20%
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$4,671
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$3,919
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INCOME FROM OPERATIONS
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$1,233
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$ 58
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OTHER INCOME (EXPENSES):
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$ (2)
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$ (5)
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NET INCOME-Before Taxes
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$1,231
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10%
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$ 53
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1%
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Income tax (benefit) provision
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$ 489
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$ -
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NET INCOME
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$ 742
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6%
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$ 53
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1%
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Slide 14
Anticipate Continued Strong Year Over Year Revenue and Operating Results Improvements
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2nd Half 2012 Revenues Anticipated to be Comparable to 2nd Half 2011
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US Public Health State by State Funding Reallocation
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Other International Orders Not Received in time for Q3 Shipment
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Record Q4 backlog Includes $1.5MM Order from Global NGO for New Chembio Market
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Brazil Business Strong in Q3 & 4
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Slide 15
CEMI Selected Share & Balance Sheet Data
(in millions except per share and daily volume data)
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Ticker Symbol (NASDAQ)
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CEMI
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Price 7/31/12
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$4.60
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52-Week High
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$5.98
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52-Week Low
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$1.68
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Outstanding Shares
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8.00
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Market Capitalization
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$36.8
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Fully Diluted Shares
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8.7
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Management Holding
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1.55
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Average Daily Volume (3 months)
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10,600
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Options
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Amt.
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Avg. Ex. Price
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515K held by Mgmt. & Board
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702K
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$1.81
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($ in millions)
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Jun’12
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Dec'11
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Dec. '10
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Cash
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$ 4,390
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$ 3,011
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$ 2,136
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Total Current Assets
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10,483
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8,992
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7,637
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Total Assets
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$16,715
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$ 15,486
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$ 9,086
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Total Current Liabilities
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3,106
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2,858
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3,076
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Total Liabilities
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3,214
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2,991
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3,277
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Total Equity
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13,501
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12,495
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5,809
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Total Liabilities & Stockholders’ Equity
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$16,715
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$ 15,486
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$ 9,086
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Slide 16
Leadership Strengthened
Executive Joined Company:
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Lawrence Siebert
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Chairman & CEO
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2002
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Richard Larkin
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CFO
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2003
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Javan Esfandiari
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SVP R&D
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2000
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Tom Ippolito
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VP Regulatory, Clinical, QA/QC
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2005
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Sharon Klugewicz
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VP QA/QC & Technical Operations
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2012
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Rick Bruce
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VP Operations
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2000
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Michael Steele
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VP Sales Marketing & Bus. Dev.
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2012
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Independent Directors Joined Board:
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Gary Meller, MD, MBA
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2005
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Katherine Davis, MBA
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2007
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Barbara DeBuono, MD, MPH
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2011
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Peter Kissinger, Ph.D
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2011
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Slide 17
Organization & Facility
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FDA & USDA- Approved Development & Manufacturing Facility
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28,000 Sq. Ft. Leased Facility in Medford, NY
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Total Employment: Approx. 170
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Reg. & Clinical QA &QC
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15
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SG&A
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11
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Research & Development
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29
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Operations
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116
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See Graphics
Slide 18
Chembio Diagnostics, Inc.
RAPID tests for EARLIER treatments
Thank You
