EX-99.2 3 investorpresentation.htm WORD VERSION OF INVESTOR PRESENTATION



Investor Presentation November 2014

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
Consistent Track Record of Revenue Growth
Global Revenue of $29.6MM (FY 2013); CAGR 21.7% (2009 to 2013)
Patented DPP® (Dual Path Platform®) Technology
Lead Product: DPP® Blood/Oral Fluid HIV Test – FDA Approved & CLIA-Waived
Future Pipeline of DPP® POC Assays
HIV-Syphilis Combination Test
HIV Antibody Assays
HCV Test
             High Value Collaborations and Development Projects
POC DPP® Assays for Ebola, Dengue Fever, Febrile Illness and Type of Cancer


Slide 5

Global POC Diagnostics Company

NORTH AMERICA
Revenue (FY '13):  $9.7MM or 35%
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 SURECHECK® HIV (July '13)
Achieved CE mark for HIV STATPAK®, (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 '13): $13.2MM or 48%
Strong OEM Partnerships (e.g., FIOCRUZ, Labtest)
Branded products sold to NGOs, private  distributors

MERA (Middle East, Russia, Africa)
Revenue (FY '13): $4.4MM or 16%
Sales channel: NGO-direct & through distributors
Procurements primarily funded by PEPFAR, Global Fund, and WHO


Slide 6

POC In-Vitro Diagnostics (IVD) Market

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
35.2 million people living with HIV/AIDS worldwide (2012)
1.6 million people died of AIDS-related illnesses (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 (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 (U.S.)
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
Chembio Global Revenue $20.2MM  FY 2013
United States: $8.9MM (14% growth  vs. FY '12)
International: $11.8MM (85% growth vs. FY '12)
Lateral flow patent expires in 2015
Chembio's royalty payments for lateral flow technology end Feb 2015

¹ Sold in U.S. as Clearview Complete® HIV 1/2


See graphics





Slide 10

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

·
Patented technology
·
Allows improved sensitivity compared to lateral flow technology
·
Enables multiple test results 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 enter market with POC HIV-Syphilis combination assay
First HIV-Syphilis Assay to be USAID Approved
Successfully launched in Latin America (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

Chembio's DPP® 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® HCV Assay
o
Assay for the detection of Hepatitis C Antibody
·
DPP® HIV Ab/Ag Assay
o
Next Generation DPP HIV for the detection of HIV Antibody and Antigen
·
DPP® HIV 1/2 Oral Fluid Assay Enhancements
o
Next Generation DPP® HIV Assay for the enhanced detection of antibodies in oral fluid


Slide 13

DPP® Collaborations
Oswaldo Cruz Foundation (Brazil)
Five DPP® Products , 2013 revenues ~$6MM
LabTest (Brazil)
Assembly, Distribution – DPP® Co-branded (2014 Product Registration)
RVR (Malaysia)
License, Technical Transfer, Contract Manufacturing, Distribution
IBT (U.S.)
Technology partnership to develop Ebola Assay
Other
Undisclosed partners for DPP® Dengue Fever and specific type of Cancer
Additional opportunities in discussion/development



Slide 14

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 cGMP
              Approximately 162 employees



Slide 15

Selected Financial Data FY2009 –2013

2013
Total Revenue $29,550
Product Revenue$ 27,516
Gross Profit $12,300
R&D Expense* $5,834
Income before taxes $1,005
Clinical Trial Expense $1,515
*            Non-recurring 2010 $1.5MM R&D Credit from the Affordable Care Act – excluded from 2010 R&D Exp. & 2010 Pre-Tax Income

See graphics


Slide 16


Selected Financial Highlights

Nine Months Ended (in 000's)
 
September 30, 2014
   
September 30, 2013
 
NET PRODUCT REVENUES
 
$
19,401
   
$
20,420
 
TOTAL REVENUES
 
$
20,550
   
$
21,689
 
GROSS MARGIN
 
$
7,906
   
$
9,031
 
INCOME FROM OPERATIONS
 
(878
)
 
$
1,181
 
NET INCOME
 
(641
)
 
$
793
 
CASH (as of end of period)
 
$
3,673
   
$
8,046
 



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 CLIA: October 2014
Corporate/Operations
Obtained POC license for certain IBT Ebola reagents: October 2014
Entered development agreements for Dengue Fever and Cancer assays: October 2014
Finalized Agreement with RVR (Malaysia) to build position in Asia: Feb 2014
Established U.S. Distribution/Warehouse facility in Holbrook, NY: May 2014
Commercial / Sales & Marketing
Terminated STAT-PAK® Distribution Agreement with U.S. Distributor: June 2014
Established Chembio U.S. Sales & Marketing team to focus on DPP® HIV 1/2 and HIV 1/2 STAT-PAK® Assays: June 2014
Signed agreements with three leading U.S. distribution companies for sales of DPP® HIV 1/2 and HIV 1/2 STAT-PAK®: September-October 2014



Slide 18

2014 Milestones - Anticipated
Corporate/Operations
Finalize additional DPP® license and/or development collaborations
Increase Manufacturing Footprint and Capacity in Medford, NY
Pursue Acquisitions or Licenses of Complementary Products/Technologies
Seek External Support to Accelerate Development of DPP® Ebola Assay
Commercial / Sales & Marketing
Expand ex-U.S. Revenues for Lateral Flow and DPP® Products
New Distribution, Contract Development & OEM Deals
International Sales Growth of DPP® HIV-Syphilis Test



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


Slide 20

Investment Highlights


Global Provider of High Quality POC Infectious Disease Tests
Sales in 43 countries
Consistent Track Record of Revenue Growth
Global Revenue of $29.6MM (FY 2013); CAGR 21.7% (2009 to 2013)
Patented DPP® (Dual Path Platform®) Technology
Lead Product: DPP® Blood/Oral Fluid HIV Test – FDA-Approved & CLIA-Waived
Future Pipeline of DPP® POC Assays
HIV-Syphilis Combination Test
HIV Antibody Assays
HCV Test
High Value Collaborations and Development Projects
POC DPP® Assays for Ebola, Dengue Fever, Febrile Illness and Type of Cancer