Attached files
| file | filename |
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| EX-99.1 - PDF OF INVESTOR PRESENTATION - CHEMBIO DIAGNOSTICS, INC. | investorpresentation.pdf |
| 8-K - FORM 8-K FOR INVES. PRES. - CHEMBIO DIAGNOSTICS, INC. | form8_k.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)
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$25.6MM 2012 Revenues, Profitable
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>25% CAGR Revenue Growth FY2009-2012
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Established & Growing Global Business of Rapid HIV & Other POCTs
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Patented DPP® - A Platform POCT Technology
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Recent FDA Approval of Oral
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Fluid HIV Test, CLIA waiver pending
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Strong Pipeline of Multiplex DPP Products
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Branded, JVs, Contract Development
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Slide 4
Chembio’s Pipeline - $850MM Total Addressable Market
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Chembio Pipeline POCT
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Total Market Opportunity
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Targeted Launch
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US HIV
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$ 75 MM
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Q4-2013
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US Syphilis-HIV
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$ 75 MM
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2H- 2014
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US HCV*
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$100 MM
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2015
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US OTC-HIV
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$100 MM
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2015-2016
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US Veterinary (OEM)*
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$100 MM
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2014
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International
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$400 MM
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2013-2016
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Total
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$850 MM
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2013-2016
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* Subject to market assessments/developments, and/or attainment of R&D and regulatory milestones
See graphic
Slide 5
Chembio’s Current & Near Term POCT Market Opportunities
HIV Rapid POCTS - Established, Growing Market
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~50,000 New Infections in US - 2012 ; 2.5 MM Worldwide
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U.S. - Routine Testing USPSTF Recommendation
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ACA Expanding Coverage by 25MM+
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International - Designation in PEPFAR & Other Donor-Funded Countries' Testing Protocols
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Syphilis Rapid 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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Leverage Global PMTCT Programs
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All HIV+ Need be Tested for Syphilis & Vice Versa
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See graphics
Slide 6
POCTs - A Growing $10B Global Market Examples of Product Opportunities for the Long Term
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Labtest Brazil*
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Veterinary Products (OEM)
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Febrile Illnesses Contract with U.S. Gov. Agency*
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Influenza Immunity Contract with CDC Contractor*
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Hepatitis-C and HIV Fourth Generation Tests
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Associated CDC Recommendations
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*announced May 2013
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 7
Current Revenues Are Primarily From Two FDA-Approved Lateral Flow Rapid HIV Tests Sold Globally
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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 2012; $2.6MM Q1’13 vs. $2.5MM Q1’12
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International Sales - Chembio Branded Through Distributors & Directly to Government-NGO-Funded Screening Programs, i.e., PEPFAR, UNICEF
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$5.7MM 2012; $2.3MM Q1’13 vs. $1.2MM Q1 ‘12
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Significant Potential 2H'13 for Continued International Revenue Growth
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See graphics
Slide 8
U.S. HIV Self-Testing “OTC” Opportunity
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Chembio Uniquely Positioned
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Still Assessing Market Size –
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OSUR Spending $7MM/QTR on HIV OTC Market Launch
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Filing IDE Q2 2013 for Sure Check® HIV
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See graphics
Slide 9
Current DPP Product Revenues From Brazil New Long Term Collaboration with Labtest
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Five DPP® Products with Brazilian MOH Affiliate, Main Supplier
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$10.1MM 2012 Revenues
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~$6MM Forecast 2013, Potential of $9MM in 2014.
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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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*announced May 2013
See graphic
Slide 10
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 11
Chembio DPP® HIV 1/2 Assay FDA-Approved Dec. ’12 CLIA Waiver expected Q4 2012
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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 12
DPP® HIV 1/2 Assay v. Leading Competitor Superior U.S. Label Claims
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DPP HIV 1/2
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Oraquick ADVANCE
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Performance
Sensitivity*
Specificity*
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99.9% WB/P/S; 99.8% FS; 98.9% OF 100% FS; 99.9% OF/WB/P/S
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(Note: No S or WB claims)
99.6% FS/P; 99.3% OF
99.9% P, 100% FS, 99.8% OF
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External Controls
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12 month open vial
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30 day open vial
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Patient Age
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2+ years of age
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12+ years of age
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Result Read Time
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25-40 min OF
10-25 min FS/P/WB/S
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20-40 min OF/FS/P
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DPP® HIV 1/2 Assay superior performance in recent studies (CDC-Mozambique) in “naïve” (undiagnosed) populations for which the test will be utilized, and more published articles on OraQuick market performance
*Note: Orasure conducted its U.S. trials 1999-2001 before widespread deployment of Highly Active Anti-Retroviral Therapy (HAART).
Note: Oral Fluid (OF), Venous Whole Blood (WB), WB Finger Stick (FS), Plasma (P), Serum (S)
Slide 13
DPP® Syphilis Screen & Confirm & HIV-Syphilis Multiplex 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
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2 Lab Tests (Trep. & Non-Trep.) in 1 POCT
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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 Submissions in
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2013, 2014 Launch
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Potential International Sales 2013
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Slide 14
Selected Financial Data FY2008 –2012
Selected Financial Data FY2008 –2012
Reporting Record Revenues Again for FY2012
(in 000’s)
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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* Non-recurring 2010 $1.5MM R&D Credit from the Affordable Care Act – excluded from 2010 R&D Exp. & 2010 Pre-Tax Income
See Graphic
Slide 15
FY2011-2012 & First Quarter 2012-2013 Selected Financial Results
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3 Mos Ended
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3 Mos Ended
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Year Ended
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Year Ended
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In (000’s)
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March 31, 2013
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March 31, 2012
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2012
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2011
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Net Product Revenues
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$6,313
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$6,363
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$24,327
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$17,422
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Non-Product Revenues
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$ 365
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$ 290
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$ 1,283
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$ 1,966
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TOTAL REVENUES
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$6,678
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$6,653
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$25,610
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$ 19,388
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GROSS MARGIN
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$2,694
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40%
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$3,333
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50%
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$ 10,790
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42%
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$9,390
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48%
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OPERATING COSTS:
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Research and Development exp
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$1,045
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16%
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$1,379
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21%
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$ 4,486
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18%
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$4,878
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25%
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Selling, G&Administrative exp
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$1,162
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17%
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$1,234
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19%
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$ 4,852
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19%
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$3,424
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18%
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$2,207
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$2,613
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$ 9,338
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$8,302
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INCOME FROM OPERATIONS
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$ 487
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$ 720
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$ 1,452
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$1,088
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OTHER INCOME (EXPENSES):
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$ 1
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$ (1)
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$ (2)
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$ (12)
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NET INCOME-Before Taxes
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$ 488
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7%
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$ 719
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11%
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$ 1,450
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6%
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$1,076
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6%
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Income tax (benefit) provision
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$ 171
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$ 286
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$ 509
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$ (5,133)
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NET INCOME
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$ 317
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5%
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$ 433
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7%
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$ 941
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4%
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$ 6,209
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32%
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Anticipated 2013 FIOCRUZ Reduction from $10.1MM in 2012 to Est. ~$6MM in 2013 May Be Offset By Significant Gains in Ex-US Lateral Flow HIV Sales
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Ex-US Lateral Flow HIV Sales $5.7MM 2012
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$2.3MM Q1’13 vs. $1.2MM Q1 ’12
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Slide 16
CEMI Selected Share & Balance Sheet Data
$6MM Common Stock Public Offering Closed on April 3, 2013
1.2MM Shares @ $5.00 per share, $5.450MM Net Proceeds
(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 04/30/13
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$4.53
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52-Week High
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$5.80
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52-Week Low
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$3.61
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Outstanding Shares
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9.29
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Market Capitalization
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$42.07
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Fully Diluted Shares
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10.01
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Management Holding
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1.62
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Average Daily Volume (3 months)
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32,000
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Average Daily Volume (1 month)
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37,800
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Options
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Amt.
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Avg. Ex. Price
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585K held by Mgmt. & Board
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725K
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$2.42
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($ in 000s)
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Pro Forma Mar’13 for
Offering Closed 4/3/13
non-GAAP
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Mar’13
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Dec ‘12
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Dec ‘11
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Cash
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$8,049
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$ 2,599
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$ 2,952
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$ 3,011
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Total Current Assets
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16,684
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11,234
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11,009
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8,992
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Total Assets
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$22,923
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$17,473
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$17,335
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$ 15,486
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Total Current Liabilities
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3,213
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3,213
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3,378
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2,858
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Total Liabilities
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3,213
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3,213
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3,460
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2,991
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Stockholders’ Equity
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19,710
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14,260
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13,875
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12,495
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Total Liabilities & Stockholders’ Equity
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$22,923
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$17,473
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$17,335
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$ 15,486
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See graphics
Slide 17
Leadership
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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Chief Financial Officer
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2003
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Sharon Klugewicz
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Chief Operating Officer
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2012
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Javan Esfandiari
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SVP Research & Development
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2000
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Tom Ippolito
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VP Regulatory & Clinical Affairs
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2005
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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 18
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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Pursuing Increased Efficiencies, Automation, Capacity
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Total Employment: Approx. 171
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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 19
Anticipated Developments - 2013-2014
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Oral Fluid HIV Test CLIA Waiver & Launch
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Direct Distribution in Public Health for Pipeline of Complementary Products
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Expanding International Revenues for Lateral Flow and DPP® Products
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FDA Submission & Approval of Two POCT Multiplex Syphilis Tests Based on DPP® Technology
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New Distribution, Contract Development & OEM Deals
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Acquire/License New Technologies, Product Lines
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Increased Production Capacity
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Slide 20
Anticipated Developments - 2013-2014
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Oral Fluid HIV Test CLIA Waiver & Launch
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Direct Distribution in Public Health for Pipeline of Complementary Products
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Expanding International Revenues for Lateral Flow and DPP® Products
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FDA Submission & Approval of Two POCT Multiplex Syphilis Tests Based on DPP® Technology
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New Distribution, Contract Development & OEM Deals
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Acquire/License New Technologies, Product Lines
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Increased Production Capacity
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