EX-99.2 3 investorpresentation.htm INVESTOR PRESENTATION- WORD



Investor Presentation August 2015

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

Our Vision & Mission

We enable longer and healthier living through detection and monitoring of serious diseases.

Our mission is to be a leader in the development and commercialization of diagnostic solutions. We are dedicated to delivering high-quality products that provide ease of use, and rapid and accurate results at the point-of-care (POC). As a global company, we are committed to innovation and the highest quality standards.



Slide 4

Investment Highlights
Global Provider of High Quality POC Infectious Disease Tests
- Sales in 43 countries
Revenue Growth Averaged 15% Over Last Five Years
- From $16.70MM for FY 2010;  to $27.65MM  for FY 2014
Patented DPP® (Dual Path Platform) Technology
- Lead Product: DPP® Blood/Oral Fluid HIV 1/2 Assay
  (FDA-Approved, CLIA-Waived)
- DPP® Revenue Growth of 137% in 2014 as compared to 2013
Future Pipeline of DPP® POC Assays
- DPP® HIV-Syphilis Combination Assay (US version)
- DPP® Fever Panel Assay (Malaria, Dengue Fever, Ebola)
New Collaborations and Development Projects
- POC DPP® Assays for Malaria, Dengue Fever, Ebola, Febrile Illness, Flu Immunostatus,
 Brain Injury and a Specific Type of Cancer


Slide 5

Global POC Diagnostics Company

U.S.
Revenue (FY '14):  $7.2MM or 28%
Established U.S. Sales & Marketing (June '14)
DPP® HIV 1/2 FDA Approved, CLIA-Waived
Funded Research: CDC, DOD, NIH (2013)

EUROPE
Achieved CE mark for SURE CHECK® HIV (July '13)
Achieved CE mark for HIV STAT-PAK®, (March '14)
Pending CE mark for DPP® HIV and DPP® HIV/Syphilis Assays

ASIA
Established License, Technical Transfer, Contract Manufacturing, Distribution  Agreement (Feb. '14)


LATIN AMERICA
Revenue (FY '14): $16.4MM or 63%
Strong OEM Partnerships (e.g., FIOCRUZ, Labtest)
Branded products sold to NGOs, private  distributors
Achieved ANVISA approval in Brazil for DPP® HIV-Syphilis Assay

MERA (Middle East, Russia, Africa)
Revenue (FY '14): $2.1MM or 8%
Sales channel: NGO-direct & through distributors
Procurements primarily funded by PEPFAR, Global Fund, and WHO


Slide 6

POC In-Vitro Diagnostics (IVD) Total Global Market

Global Professional POC Market ($ million)


 
2011 Sales
2016 Sales
CAGR
Glucose
1,530
1,640
1%
Infectious Disease
810
950
3%
Critical Care
725
875
4%
Cardiac Markers
500
650
5%
Hematology
430
500
3%
Coagulation/PT, ACT
400
450
2%
Fecal Occult Blood
295
450
9%
Cholesterol/Lipids
275
355
5%
Drugs of Abuse
265
270
0%
HbA1c
150
300
15%
Other*
150
190
n/a
Pregnancy
130
135
1%
* Source: Kalorama Worldwide Market for IVD Tests - July 2012


Slide 7

Chembio Market Opportunities

HIV Market
35 million people were living with HIV/AIDS worldwide in 2013
1.6 million people died of AIDS-related illnesses in 2012
In total, ~75 million people have been infected with the HIV virus and ~36 million have died of HIV

HIV Prevalence (15-49 years), by WHO Region  (See graphics)




Syphilis Market
Approx. 12 million people globally become ill with syphilis annually
From 2005-2013, syphilis cases in the U.S. nearly doubled, from 8,724 to 16,663
Syphilis in pregnancy leads to ~305,000 fetal & neonatal deaths annually

New Cases of STIs, by WHO Region

(See graphics)  Source: World Health Organization (2012)


Slide 8

HIV In The U.S. - The Importance of Testing

More than 1.1 million people in the United States are living with HIV infection, and almost 1 in 6 of them (15.8%) are unaware of their infection
There are ~50,000 new infections per year in the U.S.
For every HIV infection that is prevented, an estimated $355,000 is saved in the cost of providing lifetime HIV treatment

Source: Center for Disease Control & Prevention (CDC)


Slide 9

Chembio "Lateral Flow" POC Tests
·
Two Lateral Flow POC HIV Tests
Chembio HIV 1/2  STAT-PAK®
Chembio SURE CHECK® HIV 1/2 ¹
Key Product Features
FDA (PMA)-Approved, CLIA-Waived
Sensitivity: 99%
CE Marked, WHO-Approved
Lateral flow patent expired in February 2015
Chembio's royalty payment obligation for use of lateral flow technology ended Feb 2015

¹ Sold in U.S. as Clearview Complete® HIV 1/2 , sold in Europe as Chembio Stat View®HIV 1/2


See graphics





Slide 10

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

·
Patented technology
·
Allows improved sensitivity and specificity compared to lateral flow technology
·
Enables multiple test results for different diseases via a single blood sample (e.g., HIV-Syphilis Combo Assay)
·
Offers application within infectious disease and potential for a number of other indications


See graphics


Slide 11

DPP® Assays – Commercial Products

DPP® HIV 1/2 Assay
U.S. FDA (PMA) approved, CLIA-Waived  for use with blood and oral fluid samples
U.S. Launch- Q4 2014
Entering the ~$35MM oral fluid Assay market
Superior Performance (sensitivity) vs. competitors
Patented SampleTainer®Sample Collection System

DPP® HIV-Syphilis Combo Assay

First to market with POC HIV-Syphilis combo assay
First HIV-Syphilis Assay to be USAID Approved
First to receive ANVISA approval (Brazil)
Organizing clinical trials for US FDA approval.
Successfully launched in Mexico
Global screening opportunities:
Pregnant Women (Incidence 1.9MM)1
MSM (up to 70% HIV-Syphilis co-infection)2

1World Health Organization (WHO);   2Center for Disease Control & Prevention (CDC)


Slide 12

DPP® Internal Development Pipeline

·
DPP® HIV-Syphilis Assay (U.S. market)
o
Next Generation DPP® HIV-Syphilis "Combo" Assay for detection of HIV and Syphilis Antibodies
·
DPP® HIV AB/AG Assay
o
Next Generation DPP® HIV for the detection of HIV Antibody and Antigen
Slide 13

DPP® Research Collaborations

·
DPP® Malaria Assay
o
Bill & Melinda Gates Foundation
·
DPP® Dengue Fever (Multiplex Assay)
o
Undisclosed Partner
·
DPP® Ebola Multiple Assay
o
Intergrated BioTherapeutics, Inc.
·
DPP® Flu Immunostatus Assay (Multiplex Assay)
o
Centers for Disease Control & Prevention (CDC) Contractor
·
DPP® Traumatic Brain Injury Assay
o
Perseus Science Group, LLC
·
DPP® Cancer (Specific Form) Assay
o
Undisclosed Partner



Slide 14

DPP® Technology Collaborations

Bio-Rad Laboratories, Inc. (NYSE: BIO)
DPP® Technology Used for Bio-Rad Geenius™ HIV 1/2 Confirmatory Assay
Oswaldo Cruz Foundation (Brazil)
Five DPP® Products Currently Being Sold to NGO's and Private Distributors
Centers for Disease Control & Prevention (CDC)
Research Collaboration Agreement: DPP® Ebola and DPP® Febrile Illness
LabTest (Brazil)
Assembly, Distribution – DPP® Co-branded (2015 Product Registration)
RVR (Malaysia)
License, Technical Transfer, Contract Manufacturing, Distribution
Other
Additional Opportunities in Discussion/Development


Slide 15


Chembio Manufacturing Capabilities

Leased facilities (~60,000 sq. ft.) in Medford and Holbrook, NY
High Volume Manufacturing Capabilities (>15MM tests annually)
Robust Quality Management System
POC tests serve diverse, regulated market
Audited routinely by FDA CDRH/CBER, WHO, USDA, ISO (LNE), and our partners
Expertise in manufacturing scale-up, process validation and adherence to GMP (Good Manufacturing Processes)
              Approximately 162 total employees


Slide 16

Selected Financial Highlights

Three Months Ended (in 000's)
 
June 30, 2015
   
June 30, 2014
 
NET PRODUCT REVENUES
 
$
11,936
   
$
12,153
 
TOTAL REVENUES
 
$
12,947
   
$
13,236
 
GROSS MARGIN
 
$
5,706
   
$
5,255
 
LOSS FROM OPERATIONS
 
(1,773
)
 
(616
)
NET LOSS
 
(1,311
)
 
(371
)
CASH (as of end of period)
 
$
1,564
   
$
6,835
 

Note: Accounts receivable as of 6/30/14 was $5,423 compared to 6/30/15 of $8,868


Slide 17

2014 Milestones - Achieved

Product Development/Regulatory
Achieved CE Mark for HIV 1/2 STAT-PAK®: March 2014
Received CLIA Waiver for DPP® HIV 1/2 : October 2014
Entered development agreements for Dengue Fever and specific Cancer assay: Oct 2014
Signed Agreement with CDC Contractor to Develop POC Influenza Immunity: Nov 2014

Corporate/Operations
Finalized Agreement with RVR (Malaysia) to build position in Asia: Feb 2014
Established U.S. Distribution/Warehouse facility in Holbrook, NY: May 2014
Obtained Exclusive POC license for certain IBT Ebola reagents: October 2014
Increased Manufacturing Footprint and Capacity in Medford, NY: Dec. 2014

Commercial / Sales & Marketing
Terminated STAT-PAK® Distribution Agreement with U.S. Distributor: June 2014
Established U.S. Sales & Marketing team ( DPP® HIV 1/2 , HIV 1/2 STAT-PAK®): June 2014
Signed DPP® and STAT-PAK agreements with 3 leading U.S. distributors: Sept-Oct 2014


Slide 18

2015 Milestones- Achieved & Anticipated

Product Development/Regulatory
Entered into Agreement with Perseus to Develop DPP® Brain Injury Assay:  January 2015
Grant from Bill & Melinda Gates Foundation to Develop DPP® Malaria: January 2015
Achieved ANVISA Approval for DPP® HIV-Syphilis Assay in Brazil:  February 2015
Provided DPP® Ebola Assay to CDC for Field Testing in West Africa: Q2 2015
Initiate Clinical Trial for DPP HIV-Syphilis Assay (U.S.):anticipated Q4 2015

Corporate/Operations
Hired Paul Lambotte Ph.D. (VP, Product Development): December 2014
Commercial / Sales & Marketing
Acquired Full Rights to SURE CHECK® HIV 1/2 Assay, effective June 1, 2016:  January 2015
Expand Chembio U.S. Commercialization Team: in progress during 2015
Enter into Additional Distribution Agreements in the U.S. Market: in progress during 2015
Launch DPP® HIV-Syphilis Assay in Brazil: anticipated Q4 2015

Slide 19

Executive Leadership Team

Executive:  John J. Sperzel III,   President &CEO
Previous Experience: 2011-2013, President and CEO of ITC.; 1987-2011 Axis-Shield, Bayer Diagnostics, Instrumentation Laboratory and Boehringer Mannheim
Joined:  2014

Executive:  Richard Larkin, CPA  Chief Financial Officer
Previous Experience: 2000-2003  CFO of Visual Technology Group; 1987-2000 CFO of Protex  International Corp.
Joined:  2003

Executive:  Sharon Klugewicz, M.S.  Chief Operating Officer
Previous Experience: 2009-2012, Sr. VP Scientific & Laboratory Services of Pall Corporation; 1991-2009 Pall Corporation
Joined:  2012

Executive:  Javan Esfandiari, M.S.  Chief Science and Technology Officer
Previous Experience: 1997-2000, Co-founder of Sinovus Biotech AB (Sweden), acquired by Chembio in 2000; 1993-1997 R&D Director On-Site Biotech
Joined:  2000

Executive:  Thomas Ippolito, VP Regulatory & Clinical Affairs
Previous Experience: 2000-2005, VP Quality & Regulatory of Biospecific Technologies Corp.; 1984-2000 United Biomedical Inc., Analytab Products Inc. and Eastern Long Island Hospital
Joined:  2005

Executive:  Michael Steele, VP Sales, Marketing and Business Development
Previous Experience: 2008-2011, VP Business Development of SeraCare Life Sciences; 1992-2008 Corautus Genetics, Life Therapeutics and Serologicals, Inc.
Joined:  2012

Executive:  Paul Lambotte, Ph.D
Previous Experience: 2009 – 2014, President of PLC Inc.; 2009 – 2012 Chief Science Officer Axxin Pty Ltd.; 2000-2009, VP of R&D and Business Development
Joined: 2014


Slide 20

Investment Highlights

Global Provider of High Quality POC Infectious Disease Tests
Sales in 43 countries
Revenue Growth Averaged 15% Over Last Five Years
From $16.70MM for FY 2010; to $27.65MM  for FY 2014
Patented DPP® (Dual Path Platform) Technology
Lead Product: DPP® Blood/Oral Fluid HIV 1/2 Assay (FDA-Approved, CLIA-Waived)
DPP® Revenue Growth of 137% in 2014 as compared to 2013
Future Pipeline of DPP® POC Assays
DPP® HIV-Syphilis Combination Assay (US version)
DPP® Fever Panel Assay (Malaria, Dengue Fever, Ebola)
New Collaborations and Development Projects
POC DPP® Assays for Malaria, Dengue Fever, Ebola, Febrile Illness, Flu Immunostatus, Brain Injury and a Specific Type of Cancer