Corporate Fact Sheet
January 8, 2018
STOCK INFORMATION (as of January 5, 2018)
Ticker: CEMI
Exchange: Nasdaq
Share Price: $ 8.24/share
Market Cap: $101.5 Million
CORPORATE HIGHLIGHTS
A global leader in point-of-care (POC) infectious disease diagnostics
| § | Global commercialization organization servicing the U.S., Europe, Africa, Asia Pacific and Latin America |
| § | Operations and manufacturing in the U.S. and Southeast Asia |
Groundbreaking patented DPP® technology platform
| § | Superior sensitivity and specificity vs. traditional lateral flow technology |
| § | Multiple tests from a tiny (10uL) drop of fingertip blood (multiplexing) |
Robust pipeline of new DPP® POC assays in development
| § | DPP® HIV-Syphilis Combination Assay (U.S. version) |
| § | DPP® Fever Assays –Africa (Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg) |
| § | DPP®Fever Assay-Asia (Maleria, Dengue, Zika, Chikungunya, Leptospirosis, Rickettsia typhi, Burkholderia Pseudomallei Orientia tsutsugamushi.) |
| § | DPP® Technology Collaborations (Traumatic Brain Injury, Cancer, Bovine TB) |
Multiple high-value collaborations
| § | 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 |
COMPANY SNAPSHOT
Chembio Diagnostics, Inc. (NASDAQ: CEMI) develops, manufactures, licenses and markets rapid diagnostic assays in the growing $8.0 billion point-of-care (POC) testing market. In addition to its branded and proprietary HIV and fever disease assays, which it sells in the U.S. and/or internationally, the Company has several ongoing collaborations for the development of diagnostic assays for Malaria, Dengue Fever, Zika, Ebola and other febrile illness, brain injury and a specific form of cancer.
Dual Path Platform (DPP®) is Chembio's patented POC technology, which offers significant advantages over lateral-flow technologies including enhanced sensitivity and the ability to conduct multiple tests from a single sample (multiplexing). DPP® continues to provide Chembio with a growing pipeline of business opportunities for the development and manufacture of new products.
CHEMBIO'S LEAD PRODUCTS
DPP® HIV-Syphilis Assay *available in selected non-U.S. markets
| o | Rapid, multiplex detection of HIV 1, HIV 2 and syphilis using a single sample |
DPP® HIV 1/2 Assay
| o | Rapid detection of HIV 1 and HIV 2 antibodies in oral fluid and all blood matrices |
HIV 1/2 STAT-PAK® Assay
| o | Single-use, rapid, visual detection of HIV 1 and HIV 2 antibodies |
SURE CHECK® HIV 1/2 Assay
| o | Self-contained, single-use collection & testing device |
(See graphics)
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CHEMBIO'S DPP® DUAL PATH PLATFORM
| § | 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 |
(See graphics)
SALES AND MARKETING
| § | 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 |
MANUFACTURING AND OPERATIONS
| § | 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 |
Sexually Transmitted Diseases
HIV
| 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 |
SYPHILIS
| 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 |
Fever Diseases
Malaria
| · | Approximately 214 million infections and 438,000 deaths annually (2015) |
Dengue Fever
| · | Approximately 390 million infections annually with 40% of the world population at risk (2013) |
Ebola
| · | Approximately 28,000 infections and 11,000 deaths in 2014 – 2015 |
Zika
| · | Since 2015, the geographical range of Zika virus has expanded rapidly, with transmission reported in 60+ countries |
DPP PIPELINE & COLLABOTATORS
Chembio Current Internal Development:
• DPP® HIV-Syphilis Assay (U.S. market)
• DPP® Malaria Assay
• DPP® Chikungunya Assay
Current Development Collaborations:
• DPP® Dengue Fever – Undisclosed collaborator
• DPP® Ebola & Febrile Illness – CDC Research Agreement
• DPP® Fever Panel – Africa- The Paul G. Allen Ebola Program
• DPP® Fever Panel – Asia- FIND
• DPP® Malaria OF/Saliva– The Bill & Melina Gates Foundation
• DPP® Zika Assay – The Paul G. Allen Family Foundation & HHS/BARDA
• DPP® Zika/Dengue/Chikungunya Assay – HHS/BARDA (HHS option)
• DPP® Traumatic Brain Injury – Perseus Science Group LLC
• DPP® Cancer (a specific form) – Undisclosed collaborator
• DPP® BovidTB Assay – U.S. Department of Agriculture
Tech Transfer and Distribution:
• DPP® technology for Geenius™ HIV 1/2 Confirmatory Assay – Bio Rad
• DPP® product distribution in Brazil – Oswaldo Cruz Foundation
• DPP® co-branding and distribution in Brazil – Labtest Diagnostica SA
SENIOR EXECUTIVE OFFICERS
John J. Sperzel III, Chief Executive Officer
Javan Esfandiari, M.S., Chief Science & Technology Officer
Neil A. Goldman CPA, EVP & Chief Financial Officer
Sharon Klugewicz, M.S., President, America's Region
Robert Passas, Ph.D, President, EMEA & APAC Regions
| 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 | | |
