Attached files
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| EX-99.1 - EXHIBIT 99.1 SHAREHOLDER PRESENTATION - CHEMBIO DIAGNOSTICS, INC. | shareholderpresentation.pdf |
| 8-K - FORM 8K - CHEMBIO DIAGNOSTICS, INC. | form8_k.htm |
RAPID Tests for EARLIER Treatment
Annual Shareholders Meeting
September 22, 2011
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 obtain additional financing 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
Slide 3
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Chembio Overview
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Develops, Manufactures and Markets Rapid Point of Care Test (POCT) Products
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Current POCTs for HIV, Syphilis & Other Infectious Diseases, applicable to many other market segments
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Branded & Private Label (OEM) Strategy
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Enabled by Patented Dual Path Platform (DPP®)
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Four products approved in Brazil 2010-11 now being launched by Brazilian OEM partner
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Sure Check OTC Rapid HIV Test Initiative
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FDA & USDA Approved Leased Manufacturing Facility in Medford, NY
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130 Employees
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Slide 4
Leadership
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Executive
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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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Rick Bruce
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VP Operations
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2000
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Independent Directors
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Joined Board
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Gary Meller, MD, MBA
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2005
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Kathy 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 5
Organization & Facility
Fully Integrated FDA & USDA Approved Development & Manufacturing in 24,000 S/F Leased Facility in Medford, NY
Number of Employees:
Research and Development: 24
SG&A: 11
Reg. & Clinical QA/QC: 8
Operations: 87
Total Employment : 130
Slide 6
Financial Overview
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·
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Five Year Compounded Annual Revenue Growth of 33%
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Gross Margin Expansion Actual and %/ Sales
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2006: $1.60MM - 25%
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2010: $8.10MM - 48%
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2010 6 Mos. YTD - $3.40MM - 52%
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2011 6 Mos. YTD - $3.98MM - 55%
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Profitable 2009, 2010 and 2011YTD
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(See graphic)
Slide 7
(millions)
FY2008-2010 Results $20
Recorded revenues and Earnings $15
Improving Gross Margins $10
Controlled Operating Expenses $5
Operating Cash Flow Strengthened
Balance Sheet $0
(see graphic)
Slide 8
Selected Comparative Operating Statement Items – 2010 vs. 2011
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3mos. June 30, 2011
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3mos. June 30, 2010
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June 30,
2011-YTD
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June 30,
2010-YTD
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December 31, 2010
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Net Product Revenues
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$ 2,974,379
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$ 2,335,665
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$ 5,989,442
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$ 4,550,562
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$ 13,516,359
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Non-Product Revenues
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639,772
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1,413,777
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1,260,390
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1,982,296
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3,188,344
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TOTAL REVENUES
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$ 3,614,151
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$ 3,419,442
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$ 7,249,832
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$ 6,532,858
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$ 16,704,703
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GROSS MARGIN
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2,050,278
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57%
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2,094,966
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61%
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3,976,620
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55%
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3,401,340
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52%
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8,100,699
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48%
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OPERATING COSTS:
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Research and development expenses
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1,164,872
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32%
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791,596
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23%
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2,455,014
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34%
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1,592,354
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24%
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2,586,308
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15%
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Selling, general and administrative expense
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688,259
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19%
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680,014
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20%
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1,463,630
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20%
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1,341,862
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21%
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2,940,721
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18%
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1,853,131
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1,471,610
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3,918,644
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2,934,216
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5,527,029
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INCOME FROM OPERATIONS
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197,147
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623,356
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57,976
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467,124
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2,573,670
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OTHER INCOME (EXPENSES):
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(2,308)
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(1,439)
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(5,434)
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(2,533)
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(60,326)
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NET INCOME
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194,839
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5%
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621,917
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18%
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52,542
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1%
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464,591
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7%
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2,513,344
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15%
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Slide 9
U.S. Rapid HIV Test Market
Chembio U.S. Sales Up 42% YTD vs. 2010
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Clearview
Complete
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Clearview
STAT PAK®
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DPP® HIV Screen
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OraQuick
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Uni-Gold
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(See Graphic)
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(See Graphic)
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(See Graphic)
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(See Graphic)
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(See Graphic)
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Manufacturer
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Chembio
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Chembio
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Chembio
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Orasure Technologies, Bethlehem PA
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Trinity Biotech, Dublin Ireland
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Current or Planned Distribution
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Private Label for Alere Direct & Distribution
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Private Label for Alere Direct & Distribution
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Direct & Distributors
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Direct sales force
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Direct sales force & distributors
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FDA Approval Date
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2006
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2006
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Clinical trials
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2003
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2003
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Technology
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Lateral Flow
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Lateral Flow
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Dual Path Platform (DPP®)
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Lateral Flow
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Lateral Flow
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Est. US Market Shr.
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8%
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12%
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N/A
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65%
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15%
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FDA Sensitivity
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99.7%
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99.7%
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TBD
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99.3%OF/99.6% WB
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100%
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FDA Specificity
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99.9%
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99.9%
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TBD
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99.8%OF/100% WB
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99.7%
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Features
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Sample Types
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All Blood Matrices
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All Blood Matrices
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Blood & Oral Fluid Claims being pursued
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Oral Fluid and all blood matrices except serum
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All Blood Matrices
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True IgG Control
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Y
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Y
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Y
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Y
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N
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Sample Size
(in microliters)
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<5
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<5
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<5
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<5
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40
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HIV-2
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Y
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Y
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Y
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Y
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N
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Slide 10
Revenue Growth by Category: Q2’10 YTD vs. Q2’11 YTD
June 30, 2010 ($000s) June 30, 2011 ($000s)
Lateral Flow HIV Test, US Market $2,450 $3,474
Lateral Flow HIV Test, Int’l Market $1,693 $1,461
DPP Tests
$ 6 $ 899
Other Tests
$ 402 $ 156
Non-Product Revenues (R&D
Milestones, Grants and Royalties) $1,982 $1,260
Slide 11
Revenue Growth by Category: 2009 vs. 2010
2009 ($000s) 2010 ($000s)
Lateral Flow HIV Test, US Market $5,241 $5,281
Lateral Flow HIV Test, Int’l Market $5,552 $6,830
DPP
Tests $ 620
$ 628
Other
Tests $ 960 $
777
Non-Product Revenues (R&D
Milestones, Grants and Royalties) $1,462 $3,188
Slide 12
Selected Balance Sheet Data
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($000s)
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June'11
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Dec. '10
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Dec. '09
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Dec. ‘08
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Cash
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$ 2,139
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$ 2,136
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$ 1,068
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$ 1,212
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Accounts Receivable
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1,643
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3,946
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1,776
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809
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Inventories
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2,917
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1,349
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1,556
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1,819
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Total Current Assets
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6,914
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7,637
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4,667
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4,068
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Net Fixed Assets
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778
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813
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580
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881
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Other Assets
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743
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636
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1,068
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968
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Total Assets
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$ 8,435
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$ 9,086
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$ 6,315
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$ 5,915
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Total Current Liabilities
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2,079
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3,076
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3,173
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2,402
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Total Liabilities
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2,238
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3,277
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3,227
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3,338
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Total Equity
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6,197
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5,809
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3,088
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2,577
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Total Liabilities & Stockholders Equity
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$ 8,435
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$ 9,086
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$ 6,315
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$ 5,915
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Slide 13
OEM: Progress on Four DPP® OEM Contracts with FIOCRUZ
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2010 Annual Meeting Status
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Four DPP® Products Completed
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Three DPP® Products Submitted for Regulatory Approval
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Anticipated All Four DPP® Product Approvals in 2010
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Significantly Longer Process than Expected
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2011 Annual Meeting Status
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All Five DPP® Products Approved
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Leptospirosis DPP® Product Approved August
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Completed Shipments of Other Four DPP® Products during Q3 with more anticipated in Q4
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Still anticipate >$3MM 2011 DPP® Product Revenues
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Slide 14
OEM: Multiplex DPP® OEM Development Contracts with BIO-RAD
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2010 Annual Meeting Status
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Bio-Rad - Completing Product Development Phase in Current Q2 2010
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Multiplex Influenza Test - Awarded $900K Contract
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2011 Annual Meeting Status
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Bio-Rad:
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Completed all requirements for recognition of license fee, technology transfer, supporting regulatory submission activity
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Multiplex Influenza Test:
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Prototypes delivered within specification
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Anticipate new contract award to continue development
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Slide 15
CHEMBIO BRANDED DPP® PRODUCT PIPELINE DPP HIV 1/2 Screen Assay for Oral Fluid
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2010 Annual Meeting Status
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Approved by PEPFAR for all blood matrices & oral fluid
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2011 Annual Meeting Status
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US Clinical Studies Commenced and Nearly Completed
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Anticipated 2012 Approval
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Slide 16
CHEMBIO BRANDED DPP® PRODUCT PIPELINE DPP Syphilis Screen & Confirm
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2010 Annual Meeting Status
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WHO Phase I Study Complete
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Contracts Pending for FDA clinical trials
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Submitting for CE Mark
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2011 Annual Meeting Status
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Product Validation Was Delayed for One Year
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CE Mark Submitted Q3 2011
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Clinical Trials Commenced Q3 2011
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WHO Phase II Study Complete
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Study Report being finalized
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Slide 17
DPP HCV & INFLUENZA A/B
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2010 Annual Meeting Status
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HCV
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CDC Laboratory and Field Studies Concluded
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INFLUENZA
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Prototype Completed
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2011 Annual Meeting Status
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HCV
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CDC Data Published Confirming Good Prototype Performance
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Uncertain Outlook for US HCV Rapid Testing
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INFLUENZA
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Product Development Completed
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New Regulatory Standards for CLIA waiver
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Slide 18
Other Contract Development and Grant Awards
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2010 Annual Meeting Status
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NIH $2.9MM 3 year Phase II Leptospirosis Grant Awarded June 2009
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2011 Annual Meeting Status
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$1.467MM in Qualified Therapeutic Discovery Project Grants Awarded Q3 2010
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NIH $2.4MM 3 year Phase II Tuberculosis Grant Awarded March 2011
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Slide 19
NEW INITIATIVE in 2011: SURE CHECK® HIV OTC -IDE Submission 2011
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Completed Marketing Study and Flex Studies
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Pre-IDE Meeting with FDA Scheduled Q4
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Anticipate having timetable for initiation of clinical studies by Q1 2012
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(see graphic)
Slide 20
CEMI Selected Share Data Increase of 90% Since July 2010; 300% Since July 2009;
0% Since Oct. 2006
(in millions except per share data)
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Ticker Symbol (OTC-QB)
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CEMI.QB
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Price 9/20/2011
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$0.400
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52-Week High
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$0.580
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52-Week Low
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$0.210
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Outstanding Shares
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63.3
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Market Capitalization
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$25.3
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Fully Diluted Shares
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69.8
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Management Holding
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11.6
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Average Daily Volume (3 months)
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53,439
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Options and Warrants
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Amt.
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Avg. Ex. Price
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Options
(3.89 MM held by mgmt. & board)
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5.42
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$0.192
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Warrants (MM) - Exp. Dates
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10/6/2011
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1.17
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$0.454
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2/5/2012
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0.07
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$0.810
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Total Options & Warrants
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2.41
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$0.254
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CEMI price performance (see graphic)
Slide 21
Actions Being Pursued to Enhance Shareholder Value
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Continue Delivering Improved Fundamental Operating Results
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Consider, Under Right Circumstances, Reverse Split to Qualify for NASDAQ or AMEX to Develop Interest in CEMI from a Broader Spectrum of Investors
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Slide 22
RAPID Tests for EARLIER Treatment
Annual Shareholders Meeting
September 22, 2011