Attached files
| file | filename |
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| EX-99.3 - FACT SHEET - CHEMBIO DIAGNOSTICS, INC. | factsheet.pdf |
| EX-99.3 - FACT SHEET - CHEMBIO DIAGNOSTICS, INC. | factsheet.htm |
| EX-99.2 - INVESTOR PRESENTATION - CHEMBIO DIAGNOSTICS, INC. | investorpresentation.pdf |
| EX-99.1 - EXHIBIT 99.1 PRESS RELEASE - CHEMBIO DIAGNOSTICS, INC. | ex99_1.htm |
| 8-K - FORM 8-K FOR PRESS RELEASE - CHEMBIO DIAGNOSTICS, INC. | form8_k.htm |
Investor Presentation March 7, 2017
NASDAQ:CEMI
Rapid Tests for Earlier Treatment™™
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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A global leader in point-of-care (POC) infectious disease
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Sales & marketing organization in U.S., Europe, Africa, APAC and LATAM
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Manufacturing operations in the U.S. (Medford, NY) and Southeast Asia (Malaysia)
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Groundbreaking patented DPP® technology platform
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Superior sensitivity and specificity vs. traditional lateral flow technology
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Multiple tests from a tiny (10μL) drop of fingertip blood (multiplexing)
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Robust pipeline of new DPP® POC assays in development
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DPP® HIV-Syphilis Combination Assay (U.S. version)
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DPP® Fever Assays (Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg)
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DPP® Technology Collaborations (Traumatic Brain Injury, Cancer, Bovine TB)
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Multiple high-value collaborations
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U.S. Government:
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HHS/ASPR/BARDA: Zika (option: Zika/Dengue/Chikungunya);
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CDC: Malaria, Ebola, Zika, Zika/Dengue/Chikungunya
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Paul G. Allen Ebola Program: Fever Panel, Zika
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Bill & Melinda Gates Foundation: Malaria Oral Fluid/Saliva
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Slide 4
Chembio's Dual Path Platform (DPP®) Technology
Next-Generation Point-of-Care Technology Platform
Next-Generation Point-of-Care Technology Platform
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Patented POC technology platform
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Improved sensitivity vs. lateral flow technology
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Multiplex capability - multiple test results from a single patient sample
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Adapts to multiple sample types (blood, oral fluid)
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Application across a range of diseases and markets
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Unique sample collection device: Sampletainer®
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See graphics
Slide 5
Chembio's Dual Path Platform (DPP®) Technology
Leveraging Our Technology Platform to Enter New Markets
Three areas of Strategic Focus:
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STD Business
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Fever Portfolio
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Technology Collaborations
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DPP® Technology Platform
Slide 6
HIV Continues to be a Global Health Crisis
Syphilis HIV-Syphilis Co-Infection are Increasing
United States (HIV)
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~ 1.2 million living with HIV/AIDS
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~ 50,000 new HIV infections/year
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~1 in 8 unaware of HIV infection
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United States (SYP)
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~63,000 new infections (2014)
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Global (HIV)
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~36.7 million living with HIV/AIDS (2015)
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~1.1 million died of AIDS-related illnesses (2015)
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Global (SYP)
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~12 million new infections/year
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Source: Centers for Disease Control & Prevention (CDC) website; World Health Organization (WHO) website
Slide 7
Chembio Lateral Flow HIV Tests
Foundational HIV Product Suite
Product Features & Benefits
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FDA (PMA) approved, CLIA-waived
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CE marked, WHO pre-qualified
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2.5 - 5.0 μL blood sample
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15 - 20 minute test time
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Specificity: 99.9%, Sensitivity: 99.7%
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Commercialization
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High quality brands, marketed globally since 2007
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Sold to Public Health Clinics, POLs, Hospitals, Self Test (EU)
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Distribution Partners (US): Fisher, McKesson/PSS, H. Schein, Medline, Caribbean: Isla Lab
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See graphics
Slide 8
Chembio DPP® HIV and DPP® HIV-SYP Combo Tests
Strengthening our HIV/STD Portfolio
Strengthening our HIV/STD Portfolio
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DPP® HIV-Syphilis Combo Assay
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Chembio has a history of leadership
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First to receive USAID, ANVISA, Cofepris approval
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First to market/sell in Latin America
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Global screening opportunity:
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Pregnant women
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MSM (up to 70% HIV-Syphilis co-infection)
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Initiated US clinical trials for FDA approval and CLIA Waiver (expected trials completionQ1 2017)
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DPP® HIV 1/2 Assay
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FDA-approved (2013), CLIA-waived (2014)
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(blood and oral fluid)
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Superior performance vs. competitors
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(sensitivity)
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Patented SampleTainer® Sample Collection System
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See graphics
Slide 9
Chembio's Dual Path Platform (DPP®) Technology
Leveraging Our Technology Platform to Enter New Markets
Three areas of Strategic Focus:
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STD Business
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Fever Portfolio
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Technology Collaborations
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DPP® Technology Platform
Slide 10
Fever Disease – Product Development
Chembio is Collaborating with World Leading Organizations
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Bill & Melinda Gates foundation
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CDC - Center for Disease Control
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BARDA
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Fiocruz
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The Paul G. Allen Family Foundation
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See graphics
Slide 11
DPP® Fever Disease - Product Development
Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg
Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg
DPP® Fever Panel: Collaborator: The Paul G. Allen Family Foundation (PGAFF)
DPP® Malaria OF/Saliva Assay: Collaborator: The Bill & Melinda Gates Foundation
DPP® Malaria-Ebola Assay: Collaborator: CDC
DPP® Ebola Assay: Collaborator: CDC
DPP® Zika Assay: Collaborators: HHS/BARDA & The Paul G. Allen Family Foundation
DPP® Zika/Dengue/Chik Assay: Collaborator: HHS/BARDA
DPP® Dengue Assay: Collaborator: RVR Diagnostics
DPP® Chikungunya Assay: Chembio Internal Development
Slide 12
Fever Diseases - A Growing Global Concern
Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg
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Mosquito-Borne Illnesses
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Mosquito à world's deadliest animal
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Responsible for 725,000 deaths/year
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Global geographic coverage
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Established Fever Markets:
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Malaria: > 200 million annual infections
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Dengue: ~300 million annual infections
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Emerging Fever Markets:
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Zika
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Chikungunya
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Ebola
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Lassa
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Marburg
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What Crisis Will We Face Next?
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See graphics
Slide 13
Chembio is Well-Positioned to Address Zika Virus
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Local Zika Transmission
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2015 (Brazil) à 2017 (~60 countries)
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Who Needs to Be Tested
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Pregnant Women
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Travelers to/from Endemic Areas
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Others?
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Molecular Tests Limitations
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Laboratory test, venous sample
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Detects acute infections only - not antibodies
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No immediate results
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High cost
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Chembio Zika Test Advantage
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Convenience: POC Test; fingerstick sample
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Detects Antibodies (lgM/lgG)
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Time to Result: 15 minutes
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Low cost compared to MDX tests
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Source: Centers for Disease Control & Prevention (CDC) website
See graphics
Slide 14
DPP® Zika/Dengue/Chikungunya - Development
Demonstrates Expertise, Efficiency and Dedication
Demonstrates Expertise, Efficiency and Dedication
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DPP® Zika IgM/lgG Development/Commercialization Timeline
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Received PGAFF grant; initiated project DPP® Zika Project – 2/16
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Announced Zika collaboration with Bio-Manguinhos/Fiocruz (Brazil) – 3/16
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Completed testing of >1,000 samples (including 600 pregnant women) – 4/16
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Announced regulatory filings with FDA-EUA (US, PR), ANVISA (Brazil) – 5/16
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Announced regulatory filings with WHO-EUA, Cofepris (Mexico), CE mark – 7/16i
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Received CE mark (Europe, Caribbean)- 7/16
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Announced U.S. Government (HHS/BARDA) funding of up to $13.2 million – 8/16
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Awarded CDC Contract, DPP® Zika/Dengue/Chikungunya (Peru, India, Guatemala, Haiti)- 9/16
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Received ANVISA approval, DPP® Zika Assay –119/16
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See graphics
Slide 15
Chembio's Dual Path Platform (DPP®) Technology
Leveraging Our Technology Platform to Enter New Markets
Three areas of Strategic Focus:
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STD Business
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Fever Portfolio
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Technology Collaborations
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DPP® Technology Platform
Slide 16
Technology Collaborations:
Bio-Rad(NYSE:BIO) and opTricon (Berlin, Germany)
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Bio-Rad Geenius™ System: HIV-1 and HIV-2 Confirmation
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Multiplex DPP® Assay
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Developed by Chembio
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Licensed by Bio-Rad
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Marketed/sold by Bio-Rad (ex-Brazil)
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Chembio DPP® Micro Reader: Quantitative Results & Data Mgmt.
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Improves DPP ® Performance
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Provides quantitative results
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Standardizes result interpretation
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Data capture, storage, transmission
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Key features: Simple, palm-sized, easy-to-read, battery-operated, cost-effective
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See graphics
Slide 17
Chembio's Dual Path Platform (DPP®) Technology
Leveraging Our Technology Platform to Enter New Markets
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DPP® Cancer Assay
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Undisclosed Partner
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Biomarkers to Detect Specific Form of Cancer
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10uL Blood Sample, 20 Minute Test
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Quantitative Result
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In Development Phase
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DPP® TBI/Concussion Assay
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Perseus Science Group, LLC
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Biomarker to Detect TBI/Concussion
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10uL Blood Sample, 20 Minute Test
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Quantitative Result
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In Development Phase
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DPP® BovineTB
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U.S. Department of Agriculture (USDA)
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Biomarker to detect bovine tuberculosis
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20 minute test results
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In development phase
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See graphics
Slide 18
Chembio's Global Commercial Organization
Shift from Product Supply Model to Direct Sales Model
Shift from Product Supply Model to Direct Sales Model
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Regained control of U.S. HIV products (2014 – 2016)
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Terminated prior U.S. distribution agreements (HIV 1/2 STAT-PAK® and SURE CHECK® HIV 1/2)
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Developed internal commercialization structure (2014 – 2016)
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Direct sales of DPP® HIV 1/2, HIV 1/2 STAT-PAK®, and SURE CHECK® HIV 1/2 products in the U.S. market
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Established geographic coverage model in U.S. (2014 – 2016)
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Established agreements with U.S. distributors (e.g., McKesson, H. Schein, Fisher, Medline)
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Hired Experienced and Accomplished Leadership (Q4 2016)
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Robert Passas, Ph.D. – President, EMEA and APAC Regions
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Trinity Biotech; The Binding Site; Abbott, Quidel
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Sharon Klugewicz - President, Americas Region
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Chembio COO; Pall Corporation
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Hired international sales executives to build commercial channels in Latin America, Africa and Asia Pacific (Q4 2016 – Q1 2017)
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Slide 19
Manufacturing Capabilities
Medford, NY Kuala Lampur, Malaysia
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Acquired RVR Diagnostics (January 2017)
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RVR Diagnostics, a subsidiary of Chembio Diagnostics
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International base of operations and existing sales revenue
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Cost effective manufacturing operations, ISO 13485 certification
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Strategic location in Southeast Asia provides access to new markets
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Regulatory access in Southeast Asia market
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Combined Manufacturing Operations
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High volume manufacturing capabilities; current capacity 25MM tests
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65,000 sq. ft. leased facilities (Medford, NY and Malaysia)
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Robust quality management system (Medford, NY)
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Full compliance with regulatory requirements (i.e., FDA, USDA, WHO, ISO)
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Expertise in manufacturing scale up, process validation and cGMP
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Total number of employees: ~165
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Slide 20
Selected Financial Highlights
Year Ended (in 000's)
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December 31, 2016
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December 31, , 2015
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Net Product Revenues
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$
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13,680
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$
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21,887
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Total Revenues
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$
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17,670
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$
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24,255
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Gross Margin
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$
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8,451
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$
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10,487
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Loss from Operations
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$
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(7,752
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$
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(3,554
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Net Loss
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$
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(13,347
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$
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(2,397
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Cash (as of end of period)
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$
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10,554
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**
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$
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5,377
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* The net loss in the 2016 period includes a tax provision for the recording of a valuation allowance on the Company's deferred tax asset of $5,801,000. This is a non-cash transaction.
**Company public offering of securities, closed August 3, 2016, increased cash balance by $12.5MM.
Experienced Executive Leadership Team
Executive: John J. Sperzel III, President &CEO
Joined Chembio: 2014
Previous Experience: 2011-2013, President and CEO of ITC.; 1987-2011 Axis-Shield, Bayer Diagnostics, Instrumentation Laboratory and Boehringer Mannheim
Executive: Richard Larkin, CPA Chief Financial Officer
Joined Chembio: 2003
Previous Experience: 2000-2003 CFO of Visual Technology Group; 1987-2000 CFO of Protex International Corp.
Executive: Javan Esfandiari, M.S. Chief Science and Technology Officer
Joined Chembio: 2000
Previous Experience: 1997-2000, Co-founder of Sinovus Biotech AB (Sweden), acquired by Chembio in 2000; 1993-1997 R&D Director of On-Site Biotech
Executive: Sharon Klugewicz, M.S. President, Americas Region
Joined Chembio: 2012
Previous Experience: 2009-2012, Sr. VP Scientific & Laboratory Services of Pall Corporation; 1991-2009 Pall Corporation
Executive: Robert Passas, Ph.D., President, EMEA & APAC Regions
Joined Chembio: 2016
Previous Experience: 2015-2016, VP, Worldwide Marketing and International Sales at Trinity Biotech; 2011-2015 Commercial Director at The Binding Site; 1993-2011 Abbott, Trinity Biotech, Quidel
Executive: Thomas Ippolito, VP Regulatory & Clinical Affairs
Joined Chembio: 2005
Previous Experience: 2000-2005, VP Quality & Regulatory of Biospecific Technologies Corp.; 1984-2000 United Biomedical Inc., Analytab Products Inc. and Eastern Long Island Hospital
Executive: Paul Lambotte, Ph.D, VP Product Development
Joined Chembio: 2014
Previous Experience: 2009 – 2014, President of PLC Inc.; 2009 – 2012 Chief Science Officer of Axxin Pty Ltd.; 2000-2009, VP of R&D and Business Development of Quidel, Inc.
Executive: David Gyorke, VP Manufacturing Operations
Joined Chembio: 2017
Previous Experience: 2011-2016, VP operations of Nanomix, 1983-2011, NeoVista, Farallon Medical, Inc., Cholestech Corporation, Bio-Rad