CEMI Chembio Diagnostics Inc

SECURITIES AND EXCHANGE COMMISSION

 

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported):  January 8, 2018 (January 8, 2018)

CHEMBIO DIAGNOSTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

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On January 8, 2018, the Company posted a PowerPoint Presentation to their website entitled "Investor Presentation January 8, 2018."  A copy of the presentation is furnished herewith as Exhibit 99.1.

Also on January 8, 2018, the Company posted an Investor Fact Sheet to their website.  A copy of the fact sheet is furnished herewith as Exhibit 99.2

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

By:    /s/ John J. Sperzel III                                      

John J. Sperzel III

Chief Executive Officer

EXHIBIT INDEX

Investor Presentation January 8, 2018

NASDAQ:CEMI

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

Mission

To develop and commercialize simple, fast and reliable point-of-care diagnostic tests that improve diagnosis or monitoring of disease

Slide 4

Chembio's Dual Path Platform (DPP^®) Technology
Next-Generation Point-of-Care Technology Platform

§	Patented point-of-care (POC) technology platform

§	Provides enhanced sensitivity vs. lateral flow technology

§	Allows multiplexing (i.e., multiple test results from a single patient sample)

§	Provides quantitative results when used with DPP® Micro Reader

§	Adapts to multiple sample types (i.e., blood, oral fluid)

§	Applies to a range of diseases and markets

§	Includes unique sample collection device (i.e., SampleTainer®)

See graphics

Slide 5

Chembio's Dual Path Platform (DPP^®) Technology

Leveraging Our Technology Platform to Enter New Markets

Three areas of Strategic Focus:

·	Sexually Transmitted Disease Business

·	Tropical and Fever Disease Business

·	Technology Collaborations

DPP® Technology Platform

Slide 6

HIV and Syphilis Continue as Global Health Concerns
Testing for co-infection important for pregnant women and MSM

United States (HIV)

·	1.1 million living with HIV

·	39,782 diagnosed with HIV

·	~1 in 7 (15%) unaware of HIV infection

United States (SYP)

·	88,042 18% increase in cases reported to CDC (2015-2016

Global (HIV)

·	36.7 million living with HIV

·	1.8 million Diagnosed with HIV

·	~1.0 million died of AIDS-related illnesses

Global (SYP)

·	~12 million new infections/year

Source: Centers for Disease Control & Prevention (CDC) website; World Health Organization (WHO) website Data as of 12/31/2016

Slide 7

Traditional Lateral Flow HIV Products
STAT-PAK ^® and SURE CHECK ^® HIV Assays

Product Features & Benefits

·	FDA (PMA) approved, CLIA-waived

·	CE marked, WHO pre-qualified

·	2.5 - 5.0 μL blood sample

·	15 - 20 minute test time

·	Specificity: 99.9%, Sensitivity: 99.7%

Commercialization

·	High quality brands, marketed globally since 2007

·	Sold to Public Health Clinics, POLs, Hospitals, Self Test (EU)

·	Distribution Partners US: Fisher, McKesson/PSS, H. Schein, Medline, Caribbean: Isla Lab

See graphics

Slide 8

Strengthening our Core STD Business
DPP^® HIV-SYP and DPP^® HIV 1/2 Assays

§	DPP® HIV-Syphilis Combo Assay

–	Chembio has a history of leadership

•	First to receive USAID, ANVISA (Brazil),   COFEPRIS (Mexico) approvals

–	Completed U.S. clinical trial for FDA PMA submission: Q4 2017

–	Global screening opportunity:

•	Pregnant women and MSM

§	DPP® HIV 1/2 Assay

–	Received FDA (PMA) approval (2013),

–	Received CLIA-waiver (2014)

–	Superior performance vs. competitors

See graphics

Slide 9

Strengthening our Core STD Business
DPP^® Syphilis Screen & Confirm and SURE CHECK ^® HIV Self Test

§	DPP® Syphilis Screen & Confirm Assay

–	Simultaneously and separately detects   treponemal and nontreponemal antibodies

–	Screen and confirm in only 15 minutes, with a single drop of fingerstick blood, on a single test

–	Sensitivity: 99.7%

§	SURE CHECK® HIV Self Test (Ex-US)

–	Simple, fast, reliable HIV assay

–	Small sample: 2.5uL fingerstick

–	Integrated sample collection device

–	Sensitivity: 99.7%; Specificity: 99.9%

See graphics

Slide 10

Fever Diseases - A Growing Global Concern
Malaria, Dengue, Zika, Chikungunya, Ebola, and Others

§	Mosquito-Borne Illnesses

–	Mosquito à world's deadliest animal

–	Responsible for 725,000 deaths/year

–	Global geographic coverage

§	Established Fever Markets:

–	Malaria:  214MM annual infections

–	Dengue: 390MM annual infections

§	Emerging Fever Markets:

–

Zika

–	Chikungunya

–

Ebola

§	Which Fever Threat Will We Face Next?

See graphics

Slide 11

Fever Disease - Product Development
Chembio Collaborates with World Leading Organizations

DPP^® Malaria Assay- Bill & Melinda Gates Foundation

DPP^® Dengue Assay-RVR Diagnostics Sdn Bhd

DPP^® Zika Assay and DPP^® Zika/Dengue/Chikungunya Assay- BARDA, FIOCRUZ, CDC

DPP^® Fever Panel Assay – Asia- FIND

DPP^® Fever Panel Assay – Africa- The Paul G. Allen Family Foundation

DPP^® Ebola Assay and DPP^® Malaria/Ebola Assay - CDC

See graphics

Slide 12

Chembio is Well-Positioned to Address Zika Virus
Key Regulatory Approvals: U.S. FDA EUA, CE mark, ANVISA

§	Local Zika Transmission

–	2015 (Brazil) à 2018 (~90 countries)

§	Who Needs to Be Tested?

–	Pregnant women

–	Residents and travelers (endemic areas)

§	Molecular (MDx) Test Limitations

–	Laboratory test, venous sample

–	Detects acute infections only - not antibodies

–

High cost

§	Chembio Zika Test Advantage

–	Convenience: POC test; fingerstick sample

–	Detects antibodies (IgM/IgG)

–	Quantitative results: DPP® Micro Reader

–	Time to result: 15 minutes

–	Low cost compared to MDx tests

Source: Centers for Disease Control & Prevention (CDC) website

See graphics

Slide 13

Chembio is Well-Positioned to Address Zika Virus

§	Local Zika Transmission

–	2015 (Brazil) à 2017 (~60 countries)

§	Who Needs to Be Tested

–	Pregnant Women

–	Travelers to/from endemic Areas

–

Others?

§	Molecular (MDx) Test Limitations

–	Laboratory test, venous sample

–	Detects acute infections only - not antibodies

–	No immediate results

–

High cost

§	Chembio Zika Test Advantage

–	Convenience: POC Test; fingerstick sample

–	Detects Antibodies (lgM/lgG)

–	Time to Result: 15 minutes

–	Low cost compared to MDX tests

Source: Centers for Disease Control & Prevention (CDC) website

See graphics

Slide 14

DPP^® Zika Assay Product Development Timeline
Demonstrates Speed of Development and Scientific Expertise

§	DPP® Zika IgM/lgG Development/Commercialization Timeline

–	Received PGAFF grant; initiated project DPP® Zika Project – 2/16

–	Announced Zika collaboration with Bio-Manguinhos/Fiocruz (Brazil) – 3/16

–	Completed initial testing; including 600 pregnant women – 4/16

–	Announced regulatory filings with FDA-EUA, ANVISA – 5/16

–	Announced regulatory filings with WHO-EUA, Cofepris, CE mark – 7/16

–	Received CE mark (Europe, Caribbean)- 7/16

–	Announced HHS/BARDA funding contract– 8/16

–	Awarded CDC Surveillance Program: DPP® Zika/Dengue/Chikungunya (Peru, India, Guatemala, Haiti)- 9/16

–	Received ANVISA approval, DPP® Zika Assay –11/16

–	Successful INCQS Evaluation- 2017

See graphics

Slide 15

Ongoing Technology Collaborations
Leveraging Our Patented DPP^® Technology Platform

DPP^® "Undisclosed Biomarker" Assay- AstraZeneca

DPP^® Cancer Assay- Undisclosed Collaborator

DPP^® Bovine TB Assay- USDA

DPP^® Concussion Assay- Perseus Science Group LLC

Slide 16

Chembio's Global Organization
Expanding Commercial and Manufacturing Operations

Facilities: 65,000 sq. ft.

Capacity: 25MM tests

Certification: ISO 13485

Regulatory Compliance: (FDA, WHO, USDA, ANVISA)

See graphics

Slide 17

Selected Financial Highlights

Slide 18

Investment Highlights

§	A global leader in point-of-care (POC) infectious disease

–	Sales & marketing organization in U.S., LATAM, Europe, Africa, and APAC

–	Manufacturing operations in the U.S. (NY) and Malaysia

§	Groundbreaking patented DPP® technology platform

–	Superior sensitivity and specificity vs. traditional lateral flow technology

–	Multiple tests from a tiny (10μL) 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 (Malaria, Dengue, Zika, Chikungunya, Ebola, + others)

–	DPP® Technology Collaborations (Cancer, Concussion, Undisclosed, Bovine TB)

§	Multiple high-value collaborations

–	U.S. Government: HHS/ASPR/BARDA, CDC: DPP®Zika

–	AstraZeneca: DPP® "Undisclosed Biomarker"

–	Bill & Melinda Gates Foundation: DPP® Malaria

–	Paul G. Allen Ebola Program: DPP® Fever Panel - Africa

–	FIND: DPP® Fever Panel - Asia

Slide 19

Experienced Executive Leadership Team

Executive:  John J. Sperzel III,   President &CEO

Joined Chembio: 2014

Previous Experience: 2011-2013, President and CEO of ITC/Accriva; 1987-2011 Axis-Shield, Bayer Diagnostics, Instrumentation Laboratory and Boehringer Mannheim

Executive:  Neil A. Goldman, CPA  Chief Financial Officer; Executive Vice President

Joined Chembio: 2017

Previous Experience: 2015-2017, CFO of J.S. Held; 1989-2015 Unwired Technology LLC/Delphi Corp., EPPCO Enterprises, Ernst & Young

Executive:  Javan Esfandiari, M.S.  Chief Science and Technology Officer; Executive Vice President

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; 1993-2015  The Binding Site, 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

Corporate Fact Sheet

January 8, 2018

A global leader in point-of-care (POC) infectious disease diagnostics

§	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

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

§	FIND:  Fever Panel- Asia

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.

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)

PAGE 2

§	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

 (See graphics)

§	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

•  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

• 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

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

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