EX-99.1 2 ex99_1.htm EXHIBIT 99.1 ex99_1.htm


Please see PDF of this exhibit ex99_1.pdf
 
1
Investor Presentation 2nd Quarter 2008
 
2
Forward Looking Statements
Statements contained herein that are not historical facts are forwardlooking 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 obtain additional financing and the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forwardlooking 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. 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.

3
Our Mission
·  
Provide
o  
Immediate and Critical Health Care Information
§  
Simple
§  
Accurately
§  
Cost Effectively
·  
Enable
o  
Earlier Detection
o  
Earlier Treatment
o  
Improved Outcomes

4
Point of Care Testing: An Expanding Market
·  
$30B Global In-Vitro Diagnostics Testing Market
·  
$5B 2008 Point of Care Market – 12.5% CAGR
o  
40% US; 40% EU
·  
Hospital, Physicians Offices, Alternative Sites
·  
Infectious Disease Testing
o  
<10% of US Market ; >15% CAGR

5
Chembio: Infectious Disease Segment of POCT
·  
Globalization is spreading diseases at a faster pace, increasing need for testing
o  
New diseases, resurgence of old diseases, differentiation and confirmation of related diseases
o  
High growth HIV Rapid Test Market
·  
Increases value for quick, accurate and useful information so that timely and crucial care and treatment decisions can be made

6
Proven Track Record in Executing
Key Collaborations
·  
Successful partnerships in global health arena
o  
PEPFAR, WHO, PAHO, Brazilian Ministry of Health, Clinton Foundation, Bio-Rad Mexico 
·  
Marketing agreements with Inverness Medical for FDA PMA-Approved Rapid HIV Tests
o  
Leading POCT marketing and distribution
o  
Exclusive in US for both products

7
Chembio’s FDA PMA Approved Flow Rapid HIV
Tests As Marketed By Inverness Medical

[Images of Inverness sell sheets]
 

8
Chembio’s Rapid HIV Tests Achieved 10% US Market Share in First Year

Competitive Advantages: Longer Shelf Life • Cost Competitive • Strong Sales & Distribution Network

 
Chembio
Orasure*
Trinity Biotech
No. of Test Formats
2
1
1
Sensitivity
99.7%
99.6%
100.0%
Specificity
99.9%
99.9%
99.7%
Analyte(s)
HIV 1&2
HIV 1&2
HIV 1
Samples
Whole Blood
Whole Blood & Oral Fluid
Whole Blood
U.S. Pricing
$7-$13
$11-$14
$7.50-$13
Estimated US Market
Share
10%
75%
10%
US Marketing Partner
Inverness
Abbott & Direct
Direct
True IgG Control
Yes
Yes
No
Shelf Life
24 mos.
6 mos.
12 mos.
* Orasure data are for whole blood; oral fluid sensitivity and specificity are lower
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Chembio’s Next Generation POCT Meets New Market Needs
·  
Enables more challenging sample types to be tested (e.g. oral fluid)
·  
Increases sensitivity achieved with less sample material
·  
Enhances signal clarity improves recording and reporting of results
·  
Improves multiplexing: can test for multiple conditions, thereby allowing screening and confirmatory testing at the point of care

10
DPP™ Features & Benefits
Resulting In Multiple Market Opportunities
·  
Independent flow paths for sample and conjugate allows for improved sample management
·  
Improved sensitivity achieved with less sample volume
·  
Separate conjugate clearance increases signal to noise ratio, significantly improving utility of reader technologies
·  
Multiplexing facilitated because delivery of sample to multiple test lines is uniform & simultaneous

11
Confirmatory and Multiplexed POC Tests on DPP Aid in Prevention & Treatment
[Image of HIV Confirmatory Test]
[Image of Syphilis Screen & Confirm Test]

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EXPANDING REVENUE OPPORTUNITIES FOR DPP
 
Product
Est. US Market Size
Status
Chembio Branded
HIV Test for Use with Oral Fluid & Blood Samples
$100MM
Export Sales Beginning QI 2009; US Marketing in 2010 based upon PMA submission during 2009
Syphilis Test to Screen & Confirm at the Point of Care
$100MM
CRADA with the US CDC. Completing Development in 2008.
Respiratory Multiplex Test
$130MM
Early Stage of Development
Enteric Multiplex Test
$25MM
Early Stage of Development
OEM
Screening & Confirmatory Tests
$84MM
Three Products for Brazilian Ministry of Health Affiliate; Sales Begin 2nd half 2008 subject to approval
Multiplex Infectious Disease Product
$33MM
Contract R&D for Bio-Rad Laboratories
Multiplex Bacterial Detection Product
$10MM
Contract R&D for Pall Corporation
Several Additional OEM Opportunities in Discussion in Infectious Diseases, Women’s Health and Veterinary Diagnostics

13
Chembio’s Growth Strategy
·  
Optimize lateral flow product opportunities through Inverness and other marketing partnerships
·  
Select world class OEM contract development partners that can leverage our technology with their sales channels
·  
Develop branded point of care testing products based on proprietary DPP technology

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Selected Financial Information
·  
Increasing sales at higher ASP’s
·  
Increased investment in R&D
·  
Preferred stock dividend eliminated
 
(in $000's)
 
QI 2008
   
QI 2007
   
2007
   
2006
   
2005
 
Total Revenues
  $ 2,365     $ 2,038     $ 9,231     $ 6,503     $ 3,941  
Cost of Sales
    1,303       1,378       5,369       4,486       2,609  
Gross Profit
    1,062       660       3,862       2,017       1,332  
Gross Profit %
    -44.90 %     -32.38 %     -41.84 %     -31.02 %     -33.80 %
Overhead Costs:
                                       
R&D with Regulatory
    626       319       1,907       1,401       1,365  
S, G&A
    1,248       1,252       4,831       5,196       3,265  
Total Overhead Costs
    1,874       1,571       6,738       6,597       4,630  
Operating Income (Loss)
    (812 )     911 )     2,876 )     4,580 )     3,298 )
Net Income (Loss)
    (798 )     729 )     2,627 )     4,995 )     3,252 )
Pref. Divid. & Beneficial Conv. Features
    -       354       5,645       3,210       3,517  
Net Loss Attrib. To Common Stockholders
  $ (798 )   $ (1,083 )   $ (8,272 )   $ (8,205 )   $ (6,769 )

15
Balance Sheet and Capitalization

Capital Structure Simplified December 2007
Selected Balance Sheet Data  $(000s)
 
QI 2008
   
12/31/2007
   
12/31/2006
 
Cash
    1,765       2,827       4,290  
Total Assets
    6,615       6,585       7,907  
Total Liabilities
    2,992       2,322       2,297  
Convertible Preferred Stock
    0       0       12,610  
Shareholders Equity (excl. Preferred Stock)
    3,624       4,263       (7,000 )
No. of Common Shares Issued & Outstanding
    60,537,534       60,537,534       11,295,961  

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BUSINESS SUMMARY
·  
Involved in Dynamic and Growing Markets
·  
Received Significant Regulatory Certifications and Approvals
·  
Executed Agreements for Lateral Flow Rapid Tests
o  
Inverness Medical
o  
International Distribution, Technology Transfer and Licensing for HIV Tests
·  
Developed revolutionary DPP technology for new products and partnerships

17
Catalysts 
·  
Revenue Growth from Increased Participation in US & Global Rapid HIV Test Markets
·  
Initial DPP Product Revenues in 2nd Half 2008
·  
Conclude Agreements for Development, License and Manufacture of OEM DPP Products
·  
Commercialization of New DPP Products for Syphilis and HIV
·  
Continued Improvement in Financial Results Leading to Profitability


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SENIOR MANAGEMENT & DIRECTORS

Lawrence Siebert
Chairman & CEO (51)
25 years experience in private equity, venture capital, mergers and acquisitions & finance.  Chembio investor since 1992 and CEO since 2002.  JD.
Javan Esfandiari
Senior VP R&D (41)
20 years experience in in-vitro and rapid diagnostic product development and manufacturing; Founder of Sinovus Biotech out of Swedish National Veterinary Institute; Inventor of DPP.   Joined in 2000. Masters in Molecular Biology.
Robert Aromando
Executive VP Commercial (52)
30 years of business development and marketing experience with broad range of diagnostics and pharmaceutical companies including Roche, Bracco Diagnostics, American Home Products and Covance. Joined in 2007. BA.
Richard Larkin
Chief Financial Officer (51)
25 Years experience in independent accounting and in financial and information systems including 14 as CFO of Long Island manufacturer and CFO/Consultant for ERP software company.  Joined in 2003. CPA.
Alan Carus
Director
Senior executive with 40 years experience in senior management, financial management and public and private accounting. CPA.
Katherine Davis
Director
Public and private sector financial and operational experience and former Lieutenant Governor of Indiana.
Dr. Gary Meller
Director
Broad experience in medical and information technology and pharmaceutical product development.
James Merselis
Director
30 Years of IVD industry experience, most recently CEO of Hemosense (AMEX), sold to Inverness Medical 2007.

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Investor Presentation 2nd Quarter 2008

THANK YOU