EX-99.2 6 investorpresentation.htm INVESTOR PRESENTATION- WORD VERSION


 


Investor Presentation November 8, 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


§
A global leader in point-of-care (POC) infectious disease
Sales & marketing organization in U.S., Europe, Africa, APAC and LATAM
Manufacturing operations in the U.S. (Medford, NY) and Southeast Asia (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, Lassa, Marburg)
DPP® Technology Collaborations (Traumatic Brain Injury, Cancer, Bovine TB)
§
Multiple high-value collaborations
U.S. Government:
HHS/ASPR/BARDA: Zika (HHS option: Zika/Dengue/Chikungunya);
CDC: Malaria, Ebola, Zika, Zika/Dengue/Chikungunya
Paul G. Allen Ebola Program: Fever Panel- Africa, Zika
Bill & Melinda Gates Foundation: Malaria Oral Fluid/Saliva
FIND: Fever Panel - Asia



Slide 4

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

§
Patented POC technology platform
§
Improved sensitivity vs. lateral flow technology
§
Multiplex capability - multiple test results from a single patient sample
§
Adapts to multiple sample types (blood, oral fluid)
§
Application across a range of diseases and markets
§
Unique sample collection device: 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:
·
STD Business
·
Fever Portfolio
·
Technology Collaborations
DPP® Technology Platform

Slide 6

HIV Continues to be a Global Health Crisis
U.S. Syphilis Cases Increase and Risk of HIV-Syphilis Co-Infection

United States (HIV)
·
~ 1.2 million living with HIV/AIDS
·
~ 50,000 new HIV infections/year
·
~1 in 8 unaware of HIV infection

United States (SYP)
·
~63,000* new infections (2014)

Global (HIV)
·
~36.7 million living with HIV/AIDS (2015)
·
~1.1 million died of AIDS-related illnesses (2015)

Global (SYP)
·
~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." 


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
·
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

Chembio DPP® HIV-SYP and DPP® HIV 1/2 Assays
Strengthening our HIV/STD Portfolio

§
DPP® HIV-Syphilis Combo Assay
Chembio has a history of leadership
First to receive USAID, ANVISA, COFEPRIS (Mexico) approval
First to market/sell in Latin America
Global screening opportunity:
Pregnant women
MSM (up to 70% HIV-Syphilis co-infection)

Received CE mark (Q1 2017)
Completed U.S. clinical trial for FDA PMA submission to be completedb during Q4'17
·
DPP® HIV 1/2 Assay
FDA-approved (2013), CLIA-waived (2014)
                           (blood and oral fluid)
Superior performance vs. competitors  (sensitivity)
Patented SampleTainer® Sample Collection System

See graphics


Slide 9

Chembio's Dual Path Platform (DPP®) Technology
Leveraging Our Technology Platform to Enter New Markets

Three areas of Strategic Focus:
·
STD Business
·
Fever Portfolio
·
Technology Collaborations
DPP® Technology Platform



Slide 10

Fever Disease – Product Development
Chembio is Collaborating with World Leading Organizations

Bill & Melinda Gates foundation
CDC - Center for Disease Control
BARDA
FIND
Fiocruz
The Paul G. Allen Family Foundation

See graphics


Slide 11

DPP® Fever Disease - Product Development
Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg



DPP® Fever Panel-Africa: Collaborator: The Paul G. Allen Family Foundation (PGAFF)

DPP® Malaria-Ebola Assay: Collaborator: CDC

DPP® Ebola Assay: Collaborator: CDC

DPP® Fever Panel- Asia: Collaborator: FIND

DPP® Zika Assay: Collaborators: HHS/BARDA & The Paul G. Allen Family Foundation (PGAFF)

DPP® Zika/Dengue/Chik Assay: Collaborator: HHS/BARDA

DPP® Dengue Assay: Chembio Internal Development

DPP® Chikungunya Assay: Chembio Internal Development

DPP® Malaria OF/Saliva Assay: Collaborator: The Bill & Melinda Gates Foundation



Slide 12


Fever Diseases - A Growing Global Concern
Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg

§
Mosquito-Borne Illnesses
Mosquito à world's deadliest animal
Responsible for 725,000 deaths/year
Global geographic coverage

§
Established Fever Markets:
Malaria: > 214 million annual infections
Dengue: ~390 million annual infections
§
Emerging Fever Markets:
Zika
Chikungunya
Ebola
Lassa
Marburg
§
What Crisis Will We Face Next?

Source: Centers for Disease Control & Prevention (CDC) website; World Health Organization (WHO) 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/Dengue/Chikungunya - Development
Demonstrates Expertise, Efficiency and Dedication

§
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

Chembio's Dual Path Platform (DPP®) Technology
Leveraging Our Technology Platform to Enter New Markets

Three areas of Strategic Focus:
§
STD Business
§
Fever Portfolio
§
Technology Collaborations

DPP® Technology Platform


Slide 16

Technology Collaborations:
Bio-Rad(NYSE:BIO) and DPP® Micro Reader
§
Bio-Rad Geenius™ System:   HIV-1 and HIV-2 Confirmation
Multiplex DPP® Assay
Developed by Chembio
Licensed by Bio-Rad
Marketed/sold by Bio-Rad (ex-Brazil)

§
Chembio DPP® Micro Reader: Quantitative Results & Data Management
Improves DPP ® Performance
Provides quantitative results
Standardizes result interpretation
Data capture, storage, transmission
Key features: simple, palm-sized, battery-operated, cost-effective

See graphics


Slide 17
 
Chembio's Dual Path Platform (DPP®) Technology
Leveraging Our Technology Platform to Enter New Markets

§
DPP® Cancer Assay
Undisclosed Partner
Biomarkers to Detect Specific Form of Cancer
10uL Blood Sample, 20 Minute Test
Quantitative Result
In development Phase
§
DPP® TBI/Concussion Assay
Perseus Science Group, LLC
Biomarker to Detect TBI/Concussion
10uL Blood Sample, 20 Minute Test
Quantitative Result
In development Phase

·
DPP® BovineTB
o
U.S. Department of Agriculture (USDA)
o
Biomarker to detect bovine tuberculosis
o
20 minute test results
o
In development phase

See graphics


Slide 18


Chembio's Global Commercial Organization
Shift from Product Supply Model to Direct Sales Model

§
Regained control of U.S. HIV products (2014 – 2016)
Terminated prior U.S. exclusive distribution agreements (HIV 1/2 STAT-PAK® and SURE CHECK® HIV 1/2)
§
Developed internal commercialization structure (2014 – 2016)
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)
Established agreements with U.S. distributors (e.g., McKesson, H. Schein, Fisher, Medline)
§
Hired Experienced and Accomplished Leadership (Q4 2016)
Robert Passas, Ph.D. – President, EMEA and APAC Regions
Trinity Biotech; The Binding Site; Abbott, Quidel
Sharon Klugewicz  - President, Americas Region
Chembio COO (since 2012); Pall Corporation
§
Hired international sales executives to build commercial channels in Latin America, Africa and Asia Pacific (Q4 2016 – Q1 2017)


 
 
Slide 19

Manufacturing Capabilities
Expanding Global Manufacturing and  Distribution

Medford, NY Kuala Lampur, Malaysia

o
Acquired RVR Diagnostics (January 2017), Changed name to Chembio Diagnostics Malaysia Snd Bhd
o
Chembio Diagnostics Malaysia, a subsidiary of Chembio Diagnostics
o
International base of operations and existing sales revenue
o
Cost effective manufacturing operations, ISO 13485 certification
o
Strategic location in Southeast Asia provides access to new markets
o
Regulatory access in Southeast Asia market
Combined Manufacturing Operations
o
High volume manufacturing capabilities; current capacity 25MM tests
o
65,000 sq. ft. leased facilities (Medford, NY and Malaysia)
o
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


Slide 20

Selected Financial Highlights

Quarter  Ended (in 000's)        9 Months Ended (in 000's)
   
Sept. 30, 2017
   
Sept. 30, 2016
   
Sept. 30, 2017
   
Sept. 30, 2016
 
Net Product Revenues
 
$
6,133
   
$
2,502
   
$
14,453
   
$
10,452
 
Total Revenues
 
$
7,587
   
$
3,746
   
$
18,027
   
$
13,614
 
Gross Margin
 
$
3,523
   
$
1,952
   
$
8,539
   
$
6,698
 
Loss from Operations
 
(589
)
 
(2,144
)
 
(4,398
)
 
(4,998
)
Net Loss
 
(585
)
   
(2,138
)
   
(4,373
)
 
(10,879
)*
Accounts Receivable Net
 
$
5,768
   
$
4,208
   
$
5,768
   
$
4,208
 
Cash (as of end of period)
 
$
1,872
   
$
12.172
   
$
1,872
   
$
12,172
 

Slide 21
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:  Richard Larkin, CPA  Chief Financial Officer; Executive Vice President
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; 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