Attached files
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| EX-99.2 - EXHIBIT 99.2 INVESTOR PRESENTATION - CHEMBIO DIAGNOSTICS, INC. | investorpresentation.pdf |
| EX-99.1 - EXHIBIT 99.1 FOR PR - CHEMBIO DIAGNOSTICS, INC. | ex99_1.htm |
| 8-K - FORM 8-K FOR PR - CHEMBIO DIAGNOSTICS, INC. | form8_k.htm |
Investor Presentation September 12, 2016
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 in 40+ countries, including United States
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Core business in POC HIV testing; 8% revenue growth (2010-2015)
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Groundbreaking patented DPP® technology platform
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Superior sensitivity and specificity vs lateral flow technology
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Multiple tests from a tiny (10uL) drop of blood from the fingertip (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, Micro Reader)
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Multiple high-value collaborations
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U.S. Government, HHS/ASPR/BARDA: 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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Centers for Disease Control & Prevention (CDC): Malaria, Ebola, Flu Immunostatus
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Experienced leadership team
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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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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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"Over the past decade, the number of people living with HIV has increased, while the annual number of new HIV infections has remained relatively stable." -CDC
"An estimated two million pregnancies are affected annually; approximately 25% of these pregnancies end in stillbirth or spontaneous abortion, and in a further 25% the newborn has a low birth rate or serious infection, both of which are associated with an increased risk of perinatal death" -WHO
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
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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 (Q1, 2016)
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DPP® HIV 1/2 Assay
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FDA-approved (2013), CLIA-waived (2014) (blood and oral fluid)
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Superior performance vs. competitors (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
Fever Panel, Ebola, Malaria, Malaria-Ebola
Fever Panel, Ebola, Malaria, Malaria-Ebola
DPP® Fever Panel
Collaborator: The Paul G. Allen Foundation
DPP® Zika Assay
Collaborators: HHS/BARDA & The Paul G. Allen Foundation
DPP® Malaria OF/Saliva Assay
Collaborator: Bill & Melinda Gates Foundation
DPP® Zika/Dengue/Chik Assay
Collaborator: HHS/BARDA
DPP® Malaria-Ebola Assay
Collaborator: CDC
DPP® Dengue Assay
Collaborator: Undisclosed
DPP® Ebola Assay
Collaborator: CDC
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
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Global geographic coverage
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Established Fever Markets:
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Malaria: 214 million infections
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Dengue: 300 million 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
Zika Virus
Why is Zika a Concern and Why is Chembio Well-Positioned?
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Local Zika Transmission
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2015 (Brazil) à 2016 (50+ 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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Convenience: Lab Test, Venous Sample
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Cost
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Time to Result
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Detects Acute Infections
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Chembio Zika Test Advantage
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Convenience: POC Test; Fingerstick Sample
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Cost
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Time to Result: 20 minutes
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Detects Antibodies (lgM/lgG)
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Source: Centers for Disease Control & Prevention (CDC) website
See graphics
Slide 14
DPP® Zika/Dengue/Chikungunya - Development
Zika Virus represents the latest global health crisis
Zika Virus represents the latest global health crisis
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Accelerated DPP® Zika Assay Development
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Received grant from Paul G. Allen Foundation and initiated 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 – 7/16
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Announced U.S. Government (HHS/BARDA) funding of up to $13.2 million – 8/16
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Development of Zika-related DPP® Assays
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Continued development of DPP® Dengue IgM/IgG Assay
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Initiated development of DPP® Chikungunya IgM/IgG Assay
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Initiated development of DPP® Zika/Chikungunya/Dengue IgM/IgG Combo Assay
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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: Improves 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, 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® FLU Immunostatus
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CDC / Contractor
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Identifies 9 Different Seasonal & Pandemic Flu
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10uL Blood Sample, 20 Minute Test
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In Development Phase
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See graphics
Slide 18
Manufacturing Capabilities
United States (Chembio)
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High volume manufacturing capabilities
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Current capacity: 20MM+ tests annually
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60,000 sq. ft. leased facilities
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Medford, NY and Holbrook, NY
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Robust quality management system
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Full compliance with regulatory requirements (FDA, USDA, WHO, ISO)
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Expertise in manufacturing scale up, process validation and cGMP
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Number of employees: ~140
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Malaysia (RVR)
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Completed license and technology transfer
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Completed contract manufacturing readiness
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Received initial regulatory approval for distribution of
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Chembio's products into Malaysia
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Initiated plan to manufacture certain Chembio-branded products
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Slide 19
Selected Financial Highlights
Six Months Ended (in 000's)
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June 30, 2016
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June 30, 2015
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Net Product Revenues
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$
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7,951
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$
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11,936
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Total Revenues
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$
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9,868
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12,947
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Gross Margin
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4,746
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5,706
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Loss from Operations
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(2,854
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(1,773
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Net Loss
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(8,651
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(1,311
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Cash (as of end of period)
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1,440
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1,564
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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.
**Company public offering of securities, closed August 3,2016, resulted, after expenses, in an additional approximately $12.5MM in net funds to the company.
Slide 20
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: Sharon Klugewicz, M.S. Chief Operating Officer
Joined Chembio: 2012
Previous Experience: 2009-2012, Sr. VP Scientific & Laboratory Services of Pall Corporation; 1991-2009 Pall Corporation
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: 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: Michael Steele, VP Sales, Marketing and Business Development
Joined Chembio: 2012
Previous Experience: 2008-2011, VP Business Development of SeraCare Life Sciences; 1992-2008 Corautus Genetics, Life Therapeutics and Serologicals, Inc.
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.