Nevada
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0-30379
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88-0425691
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(State or other jurisdiction
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(Commission File Number)
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(IRS Employer
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of Incorporation)
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Identification Number)
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3661 Horseblock Road
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Medford, NY 11763
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(Address of principal executive offices)
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631-924-1135
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(Registrant's Telephone Number)
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Exhibit Number
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Description
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99.1
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Press Release entitled "Chembio Diagnostics Reports First Quarter 2017 Financial Results" dated May 9, 2017
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99.2
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Presentation entitled "Investor Presentation May 2017" dated May 9, 2017
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99.3
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Investor Fact Sheet posted to the company website dated May 9, 2017
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Exhibit Number
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Description
|
99.1
|
Press Release entitled "Chembio Diagnostics Reports First Quarter 2017 Financial Results" dated May 9, 2017
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99.2
|
Presentation entitled "Investor Presentation May, 2017" dated May 9, 2017
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99.3
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Investor Fact Sheet posted to the company website dated May 9, 2017
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•
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Total revenues of $6.3 million, compared with $6.6 million.
|
•
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Product sales of $5.4 million, compared with $5.9 million.
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•
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Operating loss of $1.6 million, compared with operating loss of $0.47 million.
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•
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Net loss of $1.6 million, or $0.13 per diluted share, compared with net loss of $.30 million, or $0.03 per diluted share.
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§
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A global leader in point-of-care (POC) infectious disease
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–
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Sales & marketing organization in U.S., Europe, Africa, APAC and LATAM
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–
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Manufacturing operations in the U.S. (Medford, NY) and Southeast Asia (Malaysia)
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§
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Groundbreaking patented DPP® technology platform
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–
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Superior sensitivity and specificity vs. traditional lateral flow technology
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–
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Multiple tests from a tiny (10μL) drop of fingertip blood (multiplexing)
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§
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Robust pipeline of new DPP® POC assays in development
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–
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DPP® HIV-Syphilis Combination Assay (U.S. version)
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–
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DPP® Fever Assays (Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg)
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–
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DPP® Technology Collaborations (Traumatic Brain Injury, Cancer, Bovine TB)
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§
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Multiple high-value collaborations
|
–
|
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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–
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Paul G. Allen Ebola Program: Fever Panel- Africa, Zika
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–
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Bill & Melinda Gates Foundation: Malaria Oral Fluid/Saliva
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–
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FIND: Fever Panel - Asia
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§
|
Patented POC technology platform
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§
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Improved sensitivity vs. lateral flow technology
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§
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Multiplex capability - multiple test results from a single patient sample
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§
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Adapts to multiple sample types (blood, oral fluid)
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§
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Application across a range of diseases and markets
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§
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Unique sample collection device: Sampletainer®
|
·
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STD Business
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·
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Fever Portfolio
|
·
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Technology Collaborations
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·
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~ 1.2 million living with HIV/AIDS
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·
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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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·
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~63,000 new infections (2014)
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·
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~36.7 million living with HIV/AIDS (2015)
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·
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~1.1 million died of AIDS-related illnesses (2015)
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·
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~12 million new infections/year
|
“Between 2014 and 2015, the number of reported primary and secondary (P&S) cases in the United States increased by 19%. In the United States, approximately half of men who have sex with men (MSM) with primary and secondary (P&S) syphilis were also living with HIV. In addition, MSM who are HIV-negative and diagnosed with P&S syphilis are more likely to be infected with HIV in the future.”
·
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FDA (PMA) approved, CLIA-waived
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·
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CE marked, WHO pre-qualified
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·
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2.5 - 5.0 μL blood sample
|
·
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15 - 20 minute test time
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·
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Specificity: 99.9%, Sensitivity: 99.7%
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·
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High quality brands, marketed globally since 2007
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·
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Sold to Public Health Clinics, POLs, Hospitals, Self Test (EU)
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·
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Distribution Partners US: Fisher, McKesson/PSS, H. Schein, Medline, Caribbean: Isla Lab
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§
|
DPP® HIV-Syphilis Combo Assay
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–
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Chembio has a history of leadership
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–
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First to receive USAID, ANVISA, Cofepris approval
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–
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First to market/sell in Latin America
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–
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Global screening opportunity:
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–
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Pregnant women
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–
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MSM (up to 70% HIV-Syphilis co-infection)
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–
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Received CE mark (Q1 2017)
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–
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Completed U.S. clinical trial for FDA PMA submission and CLIA Waiver application
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·
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DPP® HIV 1/2 Assay
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–
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FDA-approved (2013), CLIA-waived (2014)
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–
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Superior performance vs. competitors (sensitivity)
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–
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Patented SampleTainer® Sample Collection System
|
·
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STD Business
|
·
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Fever Portfolio
|
·
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Technology Collaborations
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–
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Bill & Melinda Gates foundation
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–
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CDC - Center for Disease Control
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–
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BARDA
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–
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FIND
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–
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Fiocruz
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–
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The Paul G. Allen Family Foundation
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§
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Mosquito-Borne Illnesses
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–
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Mosquito à world's deadliest animal
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–
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Responsible for 725,000 deaths/year
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–
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Global geographic coverage
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§
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Established Fever Markets:
|
–
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Malaria: > 200 million annual infections
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–
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Dengue: ~300 million annual infections
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§
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Emerging Fever Markets:
|
–
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Zika
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–
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Chikungunya
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–
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Ebola
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–
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Lassa
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–
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Marburg
|
§
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What Crisis Will We Face Next?
|
§
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Local Zika Transmission
|
–
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2015 (Brazil) à 2017 (~60 countries)
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§
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Who Needs to Be Tested
|
–
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Pregnant Women
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–
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Travelers to/from Endemic Areas
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–
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Others?
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§
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Molecular (MDx) Test Limitations
|
–
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Laboratory test, venous sample
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–
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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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–
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Convenience: POC Test; fingerstick sample
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–
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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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§
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DPP® Zika IgM/lgG Development/Commercialization Timeline
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–
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Received PGAFF grant; initiated project DPP® Zika Project – 2/16
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–
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Announced Zika collaboration with Bio-Manguinhos/Fiocruz (Brazil) – 3/16
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–
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Completed initial testing; including 600 pregnant women – 4/16
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–
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Announced regulatory filings with FDA-EUA, ANVISA – 5/16
|
–
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Announced regulatory filings with WHO-EUA, Cofepris, CE mark – 7/16
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–
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Received CE mark (Europe, Caribbean)- 7/16
|
–
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Announced HHS/BARDA funding of up to $13.2 million – 8/16
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–
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Awarded CDC Surveillance Program, DPP® Zika/Dengue/Chikungunya (Peru, India, Guatemala, Haiti)- 9/16
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–
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Received ANVISA approval, DPP® Zika Assay –11/16
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–
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Successful INCQS Evaluation- 2017
|
§
|
STD Business
|
§
|
Fever Portfolio
|
§
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Technology Collaborations
|
§
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Bio-Rad Geenius™ System: HIV-1 and HIV-2 Confirmation
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–
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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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–
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Marketed/sold by Bio-Rad (ex-Brazil)
|
§
|
Chembio DPP® Micro Reader: Quantitative Results & Data Management
|
–
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Improves DPP ® Performance
|
–
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Provides quantitative results
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–
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Standardizes result interpretation
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–
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Data capture, storage, transmission
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–
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Key features: simple, palm-sized, battery-operated, cost-effective
|
§
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DPP® Cancer Assay
|
–
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Undisclosed Partner
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–
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Biomarkers to Detect Specific Form of Cancer
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–
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10uL Blood Sample, 20 Minute Test
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–
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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
|
–
|
In development Phase
|
·
|
DPP® BovineTB
|
o
|
U.S. Department of Agriculture (USDA)
|
o
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Biomarker to detect bovine tuberculosis
|
o
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20 minute test results
|
o
|
In development phase
|
§
|
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
|
§
|
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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§
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Hired Experienced and Accomplished Leadership (Q4 2016)
|
–
|
Robert Passas, Ph.D. – President, EMEA and APAC Regions
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•
|
Trinity Biotech; The Binding Site; Abbott, Quidel
|
–
|
Sharon Klugewicz - President, Americas Region
|
•
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Chembio COO; Pall Corporation
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§
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Hired international sales executives to build commercial channels in Latin America, Africa and Asia Pacific (Q4 2016 – Q1 2017)
|
o
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Acquired RVR Diagnostics (January 2017)
|
o
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RVR Diagnostics, a subsidiary of Chembio Diagnostics
|
o
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International base of operations and existing sales revenue
|
o
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Cost effective manufacturing operations, ISO 13485 certification
|
o
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Strategic location in Southeast Asia provides access to new markets
|
o
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Regulatory access in Southeast Asia market
|
o
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High volume manufacturing capabilities; current capacity 25MM tests
|
o
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65,000 sq. ft. leased facilities (Medford, NY and Malaysia)
|
o
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Robust quality management system (Medford, NY)
|
o
|
Full compliance with regulatory requirements (i.e., FDA, USDA, WHO, ISO)
|
o
|
Expertise in manufacturing scale up, process validation and cGMP
|
o
|
Total number of employees: ~165
|
March 31, 2017
|
March 31, 2016
|
|||||||
Net Product Revenues
|
$
|
5,427
|
$
|
5,917
|
||||
Total Revenues
|
$
|
6,325
|
$
|
6,601
|
||||
Gross Margin
|
$
|
3,106
|
$
|
3,166
|
||||
Loss from Operations
|
$
|
(1,630
|
)
|
$
|
(468
|
)
|
||
Net Loss
|
$
|
(1,616
|
)
|
$
|
(304
|
)
|
||
Accounts Receivable Net
|
$
|
5,682
|
$
|
4,897
|
||||
Cash (as of end of period)
|
$
|
5,582
|
$
|
2,658
|
§
|
Sales in 40+ countries
|
§
|
Global commercialization organization servicing the U.S., Europe, Africa, Asia Pacific and Latin America
|
§
|
Operations and manufacturing in the U.S. and Southeast Asia
|
§
|
Superior sensitivity and specificity vs. traditional lateral flow technology
|
§
|
Multiple tests from a tiny (10uL) drop of fingertip blood (multiplexing)
|
§
|
DPP® HIV-Syphilis Combination Assay (U.S. version)
|
§
|
DPP® Fever Assays - Africa (Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg)
|
§
|
DPP® Fever Assay - Asia (Malaria, Dengue, Zika, Chikungunya, Leptospirosis, Rickettsia Typhi, Burkholderia pseudomallei, Orientia tsutsugamushi.)
|
§
|
DPP® Technology Collaborations (Traumatic Brain Injury, Cancer, Bovine TB)
|
§
|
U.S. Government, HHS/ASPR/BARDA: Zika, Dengue, Chikungunya
|
§
|
Paul G. Allen Ebola Program: Fever Panel, Africa, Zika
|
§
|
Bill & Melinda Gates Foundation: Malaria Oral Fluid/Saliva
|
§
|
Centers for Disease Control & Prevention (CDC): Malaria, Ebola
|
§
|
FIND: Fever Panel - Asia
|
o
|
Rapid, multiplex detection of HIV 1, HIV 2 and syphilis using a single sample
|
o
|
Rapid detection of HIV 1 and HIV 2 antibodies in oral fluid and all blood matrices
|
o
|
Single-use, rapid, visual detection of HIV 1 and HIV 2 antibodies
|
o
|
Self-contained, single-use collection & testing device
|
§
|
Patented technology
|
§
|
Allows improved sensitivity and specificity compared to lateral flow technology
|
§
|
Enables multiple test results via a single blood sample (e.g., HIV-Syphilis Combo Assay)
|
§
|
Utilized with DPP® Micro Reader for semi-quantitive results
|
§
|
Offers application within infectious disease and potential for a number of other indications
|
§
|
Global commercialization organization
|
§
|
Internal sales and marketing infrastructure
|
§
|
Partnerships with leading distributors
|
§
|
Experienced and accomplished leadership
|
§
|
Strategic base of operations in Southeast Asia
|
§
|
Sales organization servicing the U.S., Europe, Africa, Asia Pacific and Latin America
|
§
|
Operations in Medford, New York and Malaysia
|
§
|
High volume manufacturing capabilities
|
§
|
65,000 sq. ft. leased facilities
|
§
|
Robust quality management system
|
§
|
Regulatory access in Southeast Asia
|
§
|
Total employees: ~165
|
o
|
Approximately 37 million people living with HIV/AIDS worldwide (2015)
|
o
|
More than 1.1 million people in the U.S. are living with HIV infection, and approximately 1 in 8 are unaware of their infection
|
o
|
Approximately 12 million people globally become ill with syphilis annually (2015)
|
o
|
From 2005-2013, syphilis cases in the U.S. nearly doubled, from 8,724 to 16,663
|
·
|
Approximately 214 million infections and 438,000 deaths annually (2015)
|
·
|
Approximately 390 million infections annually with 40% of the world population at risk (2013)
|
·
|
Approximately 28,000 infections and 11,000 deaths in 2014 – 2015
|
·
|
Since 2015, the geographical range of Zika virus has expanded rapidly, with transmission reported in 60+ countries
|
Chembio Diagnostics, Inc.
|
Investor Relations
|
Company Contact
|
3661 Horseblock Road
|
Vida Strategic Partners
|
Susan Norcott
|
Medford, NY 11763
|
Stephanie C. Diaz
|
631-924-1135 x125
|
Ph. 631-924-1135
|
(415) 675-7401
|
snorcott@chembio.com
|
Fax 631-924-2065
|
sdiaz@vidasp.com
|
|
www.chembio.com
|
|
|
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