EX-99.2 3 investorpresentation.htm INVESTOR PRESENTATION- WORD


RAPID Tests for EARLIER Treatment

Investor Presentation August 2014

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 are a provider of Point-of-Care diagnostic tests and solutions, helping people live longer and healthier lives.

Our Mission is to become a key provider in the market for rapid diagnostic Point of Care (POC) testing, through the development, manufacture, and commercialization of proprietary technology with superior performance and technical service.

Slide 4

Investment Summary

Develops, Manufactures & Markets Point-of-Care Diagnostic Tests (POCTs)
Global Sales – Direct and Through Partnerships
$8B Total Global Market with Current Pipeline Addressing $650MM Segment
Five Consecutive Years of Profitability & Revenue Growth
2013 Revenues and Product Gross Margin Increased by 15% and 8% respectively vs. 2012
Patented DPP® - A Platform POCT Technology
Uniquely Enables Multiplexing for Higher Value Tests & Increased Sensitivity
DPP® Oral Fluid HIV Test – FDA-Approved - CLIA waiver pending
DPP® HIV-Syphilis  Test- Strong outlook for ex-US sales in 2014
Pipeline of DPP® POCT Products
DPP® HCV Ab & HIV Ag-Ab Test




Slide 5

Chembio Products are well Positioned Globally for Growth in $8.0 Billion Global Market

USA
Branded Chembio products marketed in the U.S. beginning in 2014
SURE CHECK® lateral flow product marketed exclusively in U.S. by a distribution partner
DPP® HIV PMA approval (Dec'12) / CLIA pending
Funded Research Collaborations with CDC, DOD, NIH (6% FY13)

EU
CE mark approval for SURE CHECK® (July'13)
CE mark for STATPAK®, DPP® HIV HIV/Syphilis pending

ASIA
·
Feb. 2014 License, Distribution, Tech. Transfer and Contract Manufacturing Agreements

AFRICA
Procurements primarily funded by PEPFAR, Global Fund, and WHO
Sales channel; NGO-direct  & through distributors (14% FY13 revenue)
Commercial resource deployment

SOUTH/CENTRAL AMERICA
Strong OEM Partnerships (FIOCRUZ, Labtest); Branded products sold to NGOs, private  distributors (45% FY13)




Slide 6

Chembio Invests in Next Generation Technology

Technologies to Address An Array of Diseases and Conditions
·
Lateral Flow Technology
·
Single Parameter Tests
·
DPP® Technology Enabling Improved Sensitivity, Multiplexing
·
Ongoing R&D




Slide 7

Chembio's Lateral Flow Rapid HIV Tests Marketed World-Wide

Total $20.2MM  FY 2013
50%  Increase vs. FY2012
5-8.5% Royalties ending Feb. 2015
In U.S. Chembio Markets HIV 1/2 STAT PAK® and an exclusive distributer Markets SURE CHECK®
$8.9MM in FY 2013
14% Increase vs. FY2012
International Market Sold Through Multiple Channels
$11.8MM in FY2013
84.5% Increase vs. FY2012


See graphics


Slide 8

Chembio's Dual Path Platform (DPP®) Patented Point-of-Care Test Technology

·
Proprietary Platform Technology that Uniquely Enables Multiplexing for Higher Value Tests
·
Increases Sensitivity as Compared with Lateral Flow Technology
·
Validated with Numerous Partners, Regulatory Agencies
·
New DPP® Patents Issued in 2013


See graphics

Slide 9

Chembio's  Pipeline: $650MM Total Addressable Market

Chembio Pipeline POCT
Total Estimated Market Opportunity
Targeted Launch
HIV POCT – U.S.
$75 MM
$8.9MM Product Sales 2013 ; New Oral Fluid Product Launch 2014
HIV-Syphilis - U.S
$75 MM
2015
Hepatitis C POCT – U.S.
$100 MM
2016
Combined Estimated Market for Above Products– ex-U.S.
$400 MM
 
$27.5MM  Product Sales in FY2013
Significant Growth Opportunities with Current and New Products
TOTAL:
$650MM
 



Slide 10

Chembio POCT Market  Opportunities: HIV Rapid POCTS

Established, Growing Markets

U.S.
~50,000 New Infections in 2012
USPSTF Recommends Routine Testing
ACA Expanding Coverage by 25MM+
International
2.5 MM New Infections Worldwide in 2012
Designation in PEPFAR & Other Donor-Funded Countries' Testing Protocols


See graphic


Slide 11

Chembio DPP® HIV 1/2 Assay FDA-Approved Dec. '12 CLIA Waiver Application Filed with FDA, November 2013,   Anticipated Launch in 2nd half of 2014

·
Build on Established  Position/Performance  of Our FDA Lateral  Flow Products with Only Alternative to Current  ~$35MM Oral Fluid Product
·
Superior Blood Matrix Performance over Top 4 Market Share Products in Early Detection Study
·
Superior Oral Fluid Sensitivity v. Market Leader in Only Head-to-Head Study
·
User Friendly, Safe and Efficient SampleTainer™ Sample Collection System
·
Separate and Reagent-Free Oral Fluid Collection Device

See graphics


Slide 12

DPP® HIV-Syphilis Multiplex Assay
Large Global Market Opportunities for Pre-Natal and MSM Screening
Higher Prevalence of  Syphilis (1.9MM) than HIV (1.5MM) in Pregnant Women
International & US Regulatory Approval Applications and Commercialization Efforts Underway
Up to 70% HIV-Syphilis Co-Infection in MSM
First Such Test to be USAID-approved
Strong Start and Outlook  2014



Slide 13

OEM & License Agreements
Expanding Relationships and Sales Opportunities

Oswaldo Cruz Foundation
Five DPP® Products , ~$6MM 2013 revenues
Brazilian MOH Supplier
Collaboration with LabTest Brazil
Assembly & Distribution - DPP® Co-branded
2014 Plan = Initial Products Registrations
Agreement with RVR Malaysia
License, Distribution, Tech. Transfer and Contract Manufacturing
 Bio-Rad Laboratories
Exclusive Licensee for DPP® HIV Confirmatory Application
CE Marked 2013, FDA Pending



Slide 14


Commercial Strategy: Top Line Growth (Sales)

Build a Sales & Marketing Organization to Increase Our Revenue and Maximize Profits

Tactic #1:   Move up Value Stream in US Diagnostics Market "USA Direct" for Certain Products

Tactic #2:   Future Growth – New Markets and New Applications

Tactic #3:   Maximize Opportunities in Developing World Markets


Slide 15

Additional Priorities & Areas of Focus:  Technology

Technology  Investment
New Product Launch (DPP® HIV/SYP)
Develop New Technologies (HIV 4G, HCV) that Address Healthcare Concerns
Identify Additional Technologies to License/Acquire that will Complement our Commercial Strategy

See graphics


Slide 16

Organization & Facility

FDA- and USDA-Approved Development & Manufacturing Facility in 39,660 Sq. Ft. Leased Facility in Medford, NY
Company Warehouse in 21,450 Sq. Ft. Leased Facility in Holbrook, NY


TOTAL EMPLOYMENT: Approximately 175
Operations= 112 Employees
QA/QC = 15 Employees
R&D = 26 Employees
SG&A = 18 Employees

See graphics

 
Slide 17


Selected Financial Data FY2009 –2013

2013
Total Revenue $29,550
Product Revenue$ 27,516
Gross Profit $12,300
R&D Expense* $5,834
Pre-Tax Income $530,800
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 18

SIX MONTHS 2014 -2013- Selected Financial Highlights

Six Months Ended (in 000's)
 
June 30, 2014
   
   
June 30, 2013
   
 
Net Product Revenues
 
$
12,153
   
   
$
11,375
   
 
TOTAL REVENUES
   
13,236
   
     
12,072
   
 
GROSS MARGIN
   
5,255
     
40
%
   
4,975
     
41
%
INCOME FROM OPERATIONS
   
(616
)
           
107
         
NET INCOME
 
$
(371
)
   
-3
%
 
$
76
     
1
%
 
                               
CASH AS OF
 
$
6,835
           
$
9,650
         



Slide 19

2013 – 2014 YTD Milestones Achieved

Product Development/Regulatory
Received FDA PMA Approval of DPP Oral Fluid HIV Test
Substantial Progress on CLIA waiver studies
Received CE Mark for Sure Check HIV 1/2 Assay
USAID Approval, Initial Sales of HV-Syphilis Test
Corporate/Operations
Achieved  Fifth Straight Year of Sales Growth and Profitability with Strong Gains in Domestic and International Segments
Strengthened Balance Sheet with Common Stock Issuance, Establishing Institutional Shareholder Base
Increased Production Capacity to Meet Sales Growth
Commercialization
Entered International Assembly & Distribution Agreement w/Labtest of Brazil
Established Distribution, License , Tech. Transfer, Contract Manufacturer in Asia
Initial International Registrations for HIV-Syphilis ; Receiving Significant Initial Orders




Slide 20

Anticipated Milestones - 2014

Product Development/Regulatory
Oral Fluid HIV Test CLIA Waiver & Launch
CE Marks for HIV 1/2 STAT-PAK®,  DPP® HIV & HIV-Syphilis Products
International Sales Growth of DPP ® HIV-Syphilis Test
Corporate/Operations
Increase Production Capacity
Pursue Acquisitions or Licenses of Complementary Products/Technologies
Commercialization
Implement US & International Commercial Strategy, Expand Market and Sales Opportunities
Expand International Revenues for Lateral Flow and DPP® Products
New Distribution, Contract Development & OEM Deals



Slide 21

Leadership Executive Team

Executive:  John J. Sperzel III,   Chief Executive Officer
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: 20+ Years at Pall Corporation, most recently as Sr. VP - Scientific & Laboratory Services
Joined:  2012

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

Executive:  Thomas Ippolito, VP Regulatory & Clinical Affairs
Previous Experience: 25 years experience in the development of vaccines, therapeutics and IVDs working with several major pharmaceutical, vaccine and diagnostic companies
Joined:  2005

Executive:  Michael Steele, VP Sales, Marketing and Business Development
Previous Experience: 20 years of business development and strategy execution at life sciences companies Sera Care Life Sciences, Serologicals, Inc. and Corautus Genetics.
Joined:  2012

 
Slide 22


Investment Summary

Develops, Manufactures & Markets Point-of-Care Diagnostic Tests (POCTs)
Global Sales – Direct and Through Partnerships
$8B Global Market with Current Pipeline Addressing $650MM Segment
Five Consecutive Years of Profitability & Revenue Growth
2013 Revenues and Product Gross Margin Increased by 15% and 8% respectively vs. 2012
Patented DPP® - A Platform POCT Technology
Uniquely Enables Multiplexing for Higher Value Tests & Increased Sensitivity
DPP® Oral Fluid HIV Test – FDA-Approved - CLIA waiver pending
DPP® HIV-Syphilis  Test- Strong outlook for international sales in 2014
Pipeline  of DPP® POCT Products
DPP® HCV Ab & HIV Ag-Ab Test