Attached files
| file | filename |
|---|---|
| EX-99.2 - PDF OF PRESENTATION - CHEMBIO DIAGNOSTICS, INC. | investorpresentation.pdf |
| 8-K - FORM 8-K - CHEMBIO DIAGNOSTICS, INC. | form8k.htm |
| EX-99.1 - PRESS RELEASE - CHEMBIO DIAGNOSTICS, INC. | ex99_1.htm |
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 Summary
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Develops, Manufactures & Markets Point-of-Care Diagnostic Tests (POCTs) Global Sales
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$25.6MM 2012 Revenues, Profitable
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‐
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Anticipate Record Revenues in Second Half 2013
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Patented DPP® - A Platform POCT Technology
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‐
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Oral Fluid HIV Test-FDA –Approved - CLIA waiver pending
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Strong Product Pipeline of Multiplex DPP Products
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‐
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HIV-Syphilis & Syphilis Screen & Confirm Tests for International and US Markets
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HCV Ab & HIV Ag-Ab Test
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New Technologies for Multiplex Products
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New Collaboration in Brazil with LabTest
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Slide 4
Our Vision & Mission
We are a provider of Point-of-Care diagnostic tests and solutions, helping people live longer and healthier lives.
Our mission is to become a key provider in the market for rapid diagnostic Point of Care (POC) testing, through the development, manufacture, and commercialization of proprietary technology with superior performance and technical service.
Slide 5
Chembio Products are well Positioned Globally for Growth…
USA
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Distribution through Alere (36% FY12 revenue)
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DPP® HIV PMA approval (Dec'12) / CLIA pending
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Funded Research Collaborations with CDC, DOD, NIH
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EUCE mark approval for SURECHECK ® (July '13)
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CE mark for STATPAK ®, DPP ® HIV, HIV/Syphilis pending.
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SOUTH/CENTRAL AMERICA
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Strong OEM Partnerships (FIOCRUZ, Labtest); Branded products sold to NGOs, private distributors (>50% FY12)
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AFRICA
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Procurement primarily funded by PEPFAR, Global Fund, and WHO
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Sales channel; NGO-direct & through distributors (11% FY12 revenue)
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Commercial resource deployment
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Slide 6
Chembio's Pipeline - $650MM Total Addressable Market
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Chembio Pipeline POCT
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Total Market Opportunity
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Targeted Launch
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HIV POCT – U.S.
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$ 75 MM
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Q1-2014
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HIV-Syphilis & Syphilis Screen-Confirm POCTs – U.S.
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$ 75 MM
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2H- 2014
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Hepatitis C POCT – U.S.
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$100 MM
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2016
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Combined Estimated Market for Above – ex-U.S.
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$400 MM
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~$16MM in 2012; Significant Growth Opportunities with Current and New Products
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Total
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$650 MM
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See graphic
Slide 7
Chembio POCT Market Opportunities:
HIV Rapid POCTS
HIV Rapid POCTS - Established, Growing Market
U.S.
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~50,000 New Infections in - 2012
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USPSTF Recommends Routine Testing
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ACA Expanding Coverage by 25MM+
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International
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2.5MM New Infections Worldwide in 2012
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Designation in PEPFAR & Other Donor-Funded Countries' Testing Protocols
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Slide 8
Chembio's POCT Market Opportunities:
Syphilis & HCV POCTS
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HIV-Syphilis POCTS – New Market Opportunity
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Up to 70% HIV-Syphilis Co-Infection in MSM
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Higher Prevalence of Syphilis (1.9MM) than HIV (1.5MM) in Pregnant Women
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Syphilis Screen & Confirm Eliminates Past Infections; thus overtreatment
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HCV POCT – Emerging Market Opportunity
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4MM in US Infected ` 75% Unaware
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Recent Revised CDC & USPSTF Recommendations for All Baby Boomers
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New Therapeutics
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See graphic
Slide 9
POCTs - A Growing $8B Global Market - Long-term Trend Toward Molecular Levels of Detection
CURRENT CAPABILITIES
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Lateral Flow Technology
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Single parameter tests
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DPP® Technology Enabling
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Improved Sensitivity, Multiplexing
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R&D
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Signal
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Enhancement Features
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POTENTIAL NEW CAPABILITIE BEING ASSESSED
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Molecular
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Amplification Technologies
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Slide 10
Chembio's Lateral Flow Rapid HIV Tests Marketed World-Wide
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Total $13.5MM 2012 Revenues
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In U.S. Sold Exclusively through Alere (Clearview®)
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$7.8MM 2012Possibility to Sell Direct
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International Sales - Chembio Branded Through Multiple Channels:
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E.g., PEPFAR, Global Fund UNICEF, etc.
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$5.7MM 2012
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Record 2H Anticipated Based on Record $5.3MM Order Received in Q2
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See graphics
Slide 11
DPP® Patented Point of Care Technology
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Proprietary Platform Technology that Uniquely Enables Multiplexing for Higher Value Tests
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Increases Sensitivity as Compared with Lateral Flow Technology
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Validated with Numerous Partners, Regulatory Agencies
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See graphics
Slide 12
Chembio DPP® HIV 1/2 Assay FDA-Approved Dec. '12, CLIA Waiver expected Q1 2014
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No Alternative to Current ~$35MM Oral Fluid Product
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Superior blood matrix performance over top 4 market share products in early detection study
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Superior Oral Fluid sensitivity v. Market Leader in head-to-head study
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User friendly, safe and efficient SampleTainer™ Sample Collection System
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Separate and reagent free oral fluid collection device
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See graphics
Slide 13
Chembio DPP® Sales in Brazil
Expanding Relationships and Sales Opportunities
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Five DPP® Products with Brazilian MOH Supplier
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$10.1MM 2012 Revenues
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~$6MM Forecast 2013
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New Collaboration with Labtest Brazil
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Leading Brazilian IVD Company
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Addressing Private & Public Markets in Brazil
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Potential Additional Markets, Contract Manufacturing
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Assembly & Distribution - DPP® Co-branded
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2013 Plan = Initial Products Registrations
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See graphics
Slide 14
Chembio's DPP® HIV-Syphilis and Syphilis Screen & Confirm Tests
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Large Global Market Opportunities for Pre-Natal and MSM Screening
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HIV-Syphilis Comb. Leverages Global PMTCT Funding
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Syphilis Screen & Confirm – Unique POC Solution Eliminates Previously Treated Cases
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USAID and WHO Evaluations in Process
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INDRE (Mexico) Data @100% Sensitivity & Specificity
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Anticipated FDA Approvals in Q4 2014 – CLIA waiver Q1 2015
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Recent Meeting with FDA Extending Review Period Due to Change of HIV-Syphilis Production to PMA (v. 510K)
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Significant Potential International Sales 2013 -14
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Slide 15
Organization & Facility
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FDA & USDA- Approved Development & Manufacturing Facility
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All Company Operations in 30,600 Sq. Ft. Leased Facility in Medford, NY
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Total Employment: Approximately 200
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Regulatory
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4
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QA &QC
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17
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SG&A
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12
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Research & Development
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27
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Operations
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142
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See Graphics
Slide 16
Chembio's Business Strategy for Growth:
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Establish commercial capabilities to increase revenue and maximize profits
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Develop, license or acquire POCT products/technologies that add value
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Expand manufacturing capabilities to supply our customers
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Slide 17
Priorities & Areas of Focus: Growth
Commercial Operations
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Invest in Sales & Marketing to promote DPP technology globally
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Deploy sales & technical resources in key regional areas
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Technology Investment
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New Product Launch (DPP HIV?SYP, SYP S&C)
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Develop New Technologies (HIV 4G, HCV) that address healthcare concerns
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Slide 18
Priorities & Areas of Focus: Operations
Manufacturing Operations
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Process Excellence Program (Lean/Six Sigma)
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Engineering & Automation
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Targeted Cost Savings
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Productivity/Labor Efficiencies
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Scrap (10% improvement from FY12)
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Slide 19
Selected Financial Data FY2008 –2012
See Graphic
2012
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Total Revenue $25,611
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Product Revenue $24,327
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Gross Profit $10,790
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R&D Expense* $4,486
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Pre-Tax Income $1,451
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Clinical Trial Expense $820
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* Non-recurring 2010 $1.5MM R&D Credit from the Affordable Care Act – excluded from 2010 R&D Exp. & 2010 Pre-Tax Income
Slide 20
FY2011-2012 Selected Financial Results
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Year Ended
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Year Ended
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In (000's)
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Dec 31, 2012
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Dec. 31, 2011
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Net Product Revenues
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$
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24,327
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$
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17,422
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Non-Product Revenues
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$
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1,283
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$
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1,966
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TOTAL REVENUES
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$
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25,610
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$
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19,388
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GROSS MARGIN
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$
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10,790
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42
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%
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$
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9,390
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48
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%
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OPERATING COSTS:
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Research and Development exp
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$
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4,486
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18
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%
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$
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4,878
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25
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%
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Selling, General &Administrative exp
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$
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4,852
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19
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%
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$
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3,424
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18
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%
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$
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9,338
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$
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8,302
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INCOME FROM OPERATIONS
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$
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1,452
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$
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1,088
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OTHER INCOME (EXPENSES):
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$
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(2
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)
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$
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(12
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)
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NET INCOME-Before Taxes
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$
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1,450
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6
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%
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$
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1,076
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6
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%
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Income tax (benefit) provision
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$
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509
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$
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(5,133
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)
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NET INCOME
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$
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941
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4
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%
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$
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6,209
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32
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%
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2012 U.S. Lateral Flow HIV Sales $ 7.8 MM
2012 Ex-U.S. Lateral Flow HIV Sales $ 5.7 MM
2012 Brazil DPP Sales $10.1 MM
Slide 21
Six Months Ended June 2012& 2013 Selected Financial Results
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6 mos
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6 mos
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||||||||||||||
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In (000's)
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June 30, 2013
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June 30,2012
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Net Product Revenues
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$
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11,375
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$
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12,174
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Non-Product Revenues
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$
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697
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$
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563
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TOTAL REVENUES
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$
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12,072
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$
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12,737
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GROSS MARGIN
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$
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4,975
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41
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%
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$
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5,903
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46
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%
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OPERATING COSTS:
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Research and Development exp
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$
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2,546
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21
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%
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$
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2,358
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19
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%
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Selling, G&Administrative exp
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$
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2,322
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19
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%
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$
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2,313
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18
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%
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$
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4,868
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$
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4,671
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INCOME FROM OPERATIONS
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$
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107
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$
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1,232
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OTHER INCOME (EXPENSES):
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$
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9
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$
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(1
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)
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NET INCOME-Before Taxes
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$
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116
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1
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%
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$
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1,231
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10
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%
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Income tax (benefit) provision
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$
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40
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$
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489
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NET INCOME
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$
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76
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1
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%
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$
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742
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6
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%
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Anticipate Record Third Quarter and Second Half 2013 Revenues
Slide 22
Current Financial Position and Share Information
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($ in 000s)
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June'13
Unaudited
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Dec '12
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Cash
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$
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8,645
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$
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2,952
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Total Assets
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$
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23,542
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$
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17,335
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Total Liabilities
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$
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3,929
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$
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3,460
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Stockholders' Equity
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$
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19,613
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$
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13,875
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(Share Information as of September 20, 2013mation2013 Revenuese convernsitsuctsrformance and technical seviceugh the development,)
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Ticker Symbol (NASDAQ)
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CEMI
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Outstanding Shares
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9.32 million
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Fully Diluted Shares
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9.99 million
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Share Price
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$
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3.83
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Market Capitalization
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$38.26 million
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Slide 23
Leadership
Executive Previous Experience Joined:
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Lawrence Siebert,J.D.
Chairman & CEO
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1981-1991, Partner, Stanwich Partners, Inc.; 1992-2002 Siebert Associates LLC, Manager; Siebert Capital Corp. , President
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2002
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Richard Larkin, CPA
Chief Financial Officer
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2000-2003 CFO of Visual Technology Group; 1987-2000 CFO of Protex International Corp.
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2003
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Sharon Klugewicz, M.S.
Chief Operating Officer
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20+ Years at Pall Corporation, most recently as Sr. VP - Scientific & Laboratory Services
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2012
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Javan Esfandiari, M.S.
SVP Research & Development
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1993-1997, R&D Director On-Site Biotech;
1997-2000, Co-Founder of Sinovus Biotech AB (Sweden), which was acquired by Chembio in 2000
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2000
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Slide 24
Anticipated Milestones - 2013-2014
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Record Revenues in Q3 & Second Half of 2013
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Oral Fluid HIV Test CLIA Waiver & Launch
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Establishing Chembio-branded U.S. Public Health Commercial Organization for Pipeline of Complementary Products
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Expanding International Revenues for Lateral Flow and DPP® Products
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2014 FDA Submission & Approval of DPP HIV-Syphilis Test
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New Distribution, Contract Development & OEM Deals
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Increased Production Capacity
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Pursue Acquisitions or Licenses of Complementary Products/Technologies
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Slide 25
Growth Through Global Sales and Partnerships
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Global Health Markets
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PEPFAR
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Global Fund
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US Market
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FDA Approved Lateral Flow Blood Tests
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FDA Approved DPP® Oral Fluid HIV Test
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Syphilis Products – Launch 2H 2014
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•
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OEM Partnerships
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•
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FIOCRUZ
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•
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LabTest
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•
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Funded Research Collaborations
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CDC, DOD, NIH
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Hepatitis-C and HIV Fourth Generation Tests
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Slide 26
Investment Summary
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•
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Develops, Manufactures & Markets Point-of-Care Diagnostic Tests (POCTs) Used Globally
|
|
•
|
$25.6MM 2012 Revenues, Profitable
|
|
‐
|
Anticipate Record Revenues in Second Half 2013
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|
•
|
Patented DPP® - A Platform POCT Technology
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|
‐
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Oral Fluid HIV Test-FDA –Approved - CLIA waiver pending
|
|
•
|
Strong Product Pipeline of Multiplex DPP Products
|
|
‐
|
HIV-Syphilis Test for International and US Markets
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|
‐
|
HCV & HIV Ag-Ab Test
|
|
‐
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New Technologies for Multiplex Products
|
|
‐
|
New Collaboration in Brazil with LabTest
|