EX-99.2 3 ex99_2.htm EXHIBIT 99.1 PRESENTATION ex99_2.htm


Slide 1:
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Investor Presentation
November 2009

 
 

 

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 obtain additional financing 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. 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:
•  
Medford, NY  Manufacturer of Proprietary Point of Care Rapid Diagnostic Tests – 100 Employees
•  
FDA Approved Lateral Flow (LF) Rapid HIV Tests
–  
Marketed in the U.S. by Inverness Medical. Sales Increase thru Q3YTD of 120% to $3.45MM vs. $1.57MM in 2008.
•  
Total Revenues through 9 Months of $10.3MM, up 19.6%. Profitable in Q2, Q3 and YTD.
•  
New Product Pipeline Enabled by Patented Dual Path Platform (DPP®) Rapid, Point-of-Care-Testing (POCT) Platform

 
 

 

Slide 4:
Organization & Management Team
Lawrence Siebert, CEO & Chairman
Richard Larkin, CFO
Javan Esfandiari, Sr. VP R&D
Rick Bruce, VP Operations
Tom Ippolito, VP Reg., QA/QC
Sandy Speer, Dir. Client Serv.
Dr. Gary Meller, Director
Katherine Davis, Director
Total Employment Approx . 100
S, G&A 7
Ops. 69
R&D 18
Reg. & Clinical, QA & QC 7
 


 
 

 

Slide 5:
Regulatory Approvals Provide Access to
Large, Diverse & Global POCT Markets

Two FDA-Approved  PMA’s
USDA-Approved Facility & Product Licenses
ISO Certified for Global Markets

 
 

 

Slide 6:
$6.7B Global Point of Care Test (POCT) Market

Europe $3,254 (52%), U.S. Hosp. $1,772 (28%), U.S. Decentralized sites $591 (9%), etc (see PDF for more details).

At 7% Projected Increases, even with Large Low-Growth Segments (e.g., Glucose), Global POCT Market is Fastest Growing Segment of $39.5B In-Vitro Diagnostics Market, Projected to Reach $8.8B by 2012
Source: Independent Market  Research Report

 
 

 

Slide 7:
POCT Market Drivers
•  
Reduce Patient Stays and Costs, Improve Patient Outcomes with Prompt & Early Diagnosis
–  
Improve Therapeutic Intervention
–  
Prevent Needless Admissions
–  
Simplify Testing Procedures to Reduce Testing Costs
–  
Avoid Delays from Central Lab Batching
–  
Eliminate Need for Return Visit (s)

 
 

 

Slide 8:
Overview of Current Products & Revenue
2008 – Total Revenue $11,049,600

LF-HIV, Int’l - $7,008,800 (64%), LF-HIV-U.S. - $2,183,500 (20%), Other - $1,037,468 (9%), R&D $693,803 (6%), DPP $126,000 (1%).

 
 

 

Slide 9:

Overview of Current Products &  Revenue YTD
Increases from U.S. Market, DPP® and R&D Contracts
None Mos. Ended 9/30/09 – Total Revenue $10,282,807

LF-HIV, Int’l - $4,379,276 (42%), LF-HIV-U.S. - $3,450,000 (34%), Other - $796,233 (8%), R&D $954,058 (9%), DPP $619,530 (6%), Royalty Income $83,710 (1%).


 
 

 

Slide 10:

FDA Approved Rapid HIV Tests
Distributed in US Exclusively by Inverness Medical
•  
120% YTD Increase thru Q3 in US Market Revenues
–  
$3.45MM vs. $1.570MM
–  
Gains Based Upon Market Expansion and Increased Market Share
•  
Competitive Features
–  
CLIA Waived
–  
Two Formats
–  
99.7% Sensitivity; 99.9% Specificity
–  
Proprietary Formulation Enables 24 Month Stability
–  
Strong Marketing Partner


 
 

 

Slide 11:

Chembio’s Rapid HIV Tests
are Distributed Globally

•  
Approved for Procurements by UN,WHO, CDC/USAID (PEPFAR)
•  
Registered/Approved in several countries in South America, Asia, and Africa
•  
CE Mark Pending


 
 

 

Slide 12:
Estimated Projected Total Annual Sales of U.S. POCTs
2008-2012
 
Unit Growth of 79% on Sales Growth of 31% Creating Opportunity for Multiplexed Products
Chart showing Sales as follows:
2008 - $2,363
2009 - $2,529
2010 - $2,705
2011 - $2,895
2012 - $3,098
Source: Independent Market  Research Report


 
 

 

Slide 13:
PATENTED DUAL PATH PLATFORM (DPP®)
KEY DESIGN AND PERFORMANCE ADVANTAGES vs. LATERAL FLOW
•  
Independent Sample Flow Path Enables Improved Sensitivity & Use of More Challenging Sample Types
•  
Improved Multiplexing Facilitated  by Direct Binding, Uniform Delivery of Samples
•  
US Patent #7,189,522. Patent Protection  Pending Worldwide

 
 

 

Slide 14:

DPP® Global Health Products
•  
Four New Products for Brazilian Public Health Including Five Band POC HIV Confirmatory Test
•  
Three Year $3MM NIH SBIR Phase II Grant for Human Leptospirosis
 
DPP® Point of Care Test
 
Collaborating Organization
Tuberculosis
 
FIND
Malaria
 
FIND
HIV 1/2  Confirmatory Test
 
FIOCRUZ
Neglected Diseases: Leishmaniasis, Chagas, Leptospirosis, Leprosy
 
IDRI, NIH, FIOCRUZ


 
 

 

Slide 15:
DPP® HIV 1/2 Screen Assay
•  
Designed for Use with Oral Fluid & Blood
•  
$50MM/5MM Unit US Market Growing 15-20%/Year
•  
Opportunity to Gain Market Share from Sole Competitor
•  
US Clinical Trials Commencing Q4 2009

 
 

 

Slide 16:

DPP® Syphilis Screen & Confirm
•  
First POCT For Syphilis In US
•  
Provides Better Indication Of Active Disease
•  
Enables Confirmation & Treatment At POC
•  
Pre-natal Testing
•  
FDA Pre-IDE Submitted Q3

Developed in collaboration with the U.S. Centers for Disease Control

 
 

 

Slide 17:
INFLUENZA
MULTIPLEX ANTIGEN & IMMUNITY TESTS

•  
Current Lateral Flow Rapid Tests Need Improvement
•  
Initial Data Show Improved Performance with DPP®
•  
Multiplex Immune Status Serology Test H1N1 Project

 
 

 

Slide 18:

Hepatitis-C (HCV) & HIV/HCV Comb.
•  
Estimated 3MM HCV Infections in US
–  
Only 22% Diagnosed
–  
25% Co-infection with HIV
–  
Major Cause of Liver Disease
–  
New therapeutics from Vertex, etc. will drive demand for Dx
•  
No HCV Point of Care Test in US
•  
Chembio Participating in Pre-Clinical CDC Study with both prototypes

 
 

 

Slide 19:


Base Business & DPP® Product Pipeline
CHART (See – PDF for Details)


 
 

 

Slide 20:
Selected Comparative Historical Financial Results
2005-2008 and 9 Mos. of 2009
 
 
     
9 Mos Ended
   
For the Years Ended
 
  (000s)  
Sept 30, 2009
      2008       2007       2006       2005  
Total Revenues
    $ 10,283     $ 11,050     $ 9,231     $ 6,503     $ 3,941  
Cost of sales
      6,053       7,198       6,435       4,894       2,996  
Gross Profit
      4,230       3,852       2,796       1,609       945  
          41.1 %     34.9 %     30.3 %     24.7 %     24.0 %
R&D Expense
      2,127       2,605       1,907       1,402       1,365  
SG&A Expense
      2,002       3,317       3,765       4,787       2,878  
Operating Income (Loss)
      100       (2,071 )     (2,876 )     (4,580 )     (3,298 )
Other Inc. (Expense)
      (8 )     122       249       (415 )     46  
Net Income (Loss) - Stkhldrs
      92       (1,949 )     (2,627 )     (4,995 )     (3,252 )
Pref. Stock Expenses
      -       -       5,645       3,210       3,517  
Net Loss
    $ 92     $ (1,949 )   $ (8,272 )   $ 8,205 )   $ (6,769 )
Net Income (Loss) - per Share
    $ 0.00     $ (0.03 )   $ (0.57 )   $ (0.80 )   $ (0.88 )
Avg. No. Shares (Millions)
      61.945       61.267       14.608       10.293       7.705  
Working capital
    $ 2,098     $ 1,664     $ 3,229     $ 5,113     $ 831  
Total assets
      6,342       5,915       6,585       7,907       3,016  
Total liabilities
      3,534       3,338       2,322       2,297       1,964  
Equity (Deficit)
      2,808       2,577       4,263       (940 )     1,053  


 
 

 

Slide 21:

Selected Comparative Historical Financial Results
Quarter and YTD 9/30/2009 & 9/30/2008

     
Three Mos Ended
   
Nine Mos Ended
 
  (000s)    
Sept 30, 2009
   
Sept 30, 2008
   
Sept 30, 2009
   
Sept 30, 2008
 
Total Revenues
    $ 4,364     $ 3,516     $ 10,283     $ 8,598  
Cost of sales
      2,495       2,125       6,053       5,362  
Gross Profit
      1,869       1,391       4,230       3,236  
          42.8 %     39.6 %     41.1 %     37.6 %
R&D Expense
      777       759       2,127       1,952  
SG&A Expense
      784       868       2,002       2,696  
Operating Income (Loss)
      308       (236 )     100       (1,412 )
Other Inc. (Expense)
      (1 )     (1 )     (8 )     14  
Net Income (Loss) - Stkhldrs
      307       (237 )     92       (1,398 )
Pref. Stock Expenses
      -       -       -       -  
Net Loss
    $ 307     $ (237 )   $ 92     $ (1,398 )
Net Income (Loss) - per Share
    $ 0.00     $ (0.00 )   $ 0.00     $ (0.02 )
Avg. No. Shares (Millions)
      61.945       61.945       61.945       61.036  
Working capital
    $ 2,098     $ 1,656     $ 2,098     $ 1,656  
Total assets
      6,342       6,486       6,342       6,486  
Total liabilities
      3,534       3,378       3,534       3,378  
Equity (Deficit)
      2,808       3,108       2,808       3,108  



 
 

 

Slide 22:

Selected Balance Sheet Data
($000s)
           
Balance Sheet Data
 
Sept '09
   
Dec. '08
 
Cash
    $1,877       $1,212  
Accts. Receivable
    1,135       809  
Inventories
    1,374       1,819  
Other Current Assets
    309       225  
Total Current Assets
    4,695       4,066  
Net Fixed Assets
    642       881  
Other Assets
    1,005       968  
Total Assets
    6,342       5,915  
Total Current Liab.
    2,597       2,402  
Total Other Liab.
    937       936  
     Total Liabilities
    3,534       3,338  
Total Equity
    2,808       2,577  
Total Liabilities & Shareholders Equity
    6,342       5,915  



 
 

 

Slide 23:

CEMI Selected Share Data
Stock data as of 10/30/09 (see PDF for details)
Options and Warrants:
Options and Warrants (MM)
Avg. Ex. Price
       
Options (3.86MM held by mgmt. & board)
5.75
$0.16
Warrants - Exp.Dates
   
 
1/28/10
4.96
$0.47
 
10/5/11
2.64
$0.48
 
2/5/12
.07
$0.81
Total Warrants
 
7.67
 
       
Total Options & Warrants
13.42
 
       
Fully Diluted shares
  75.36  



 
 

 

Slide 24:
 
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