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

Exhibit 99.1 - SEE PDF

Slide 1:
Investor Presentation
November 2010

 


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 Point of Care Rapid Diagnostic Tests
•  
Five Year Revenue CAGR of 33%
•  
FY 2009 Total Revenues of $13.8MM
•  
Profitable in 2009 and 2010YTD through Sept. 30
•  
Anticipate $15MM+ Revenues in 2010
•  
68% of Revenues from FDA Approved Rapid HIV Tests Marketed Globally
•  
in U.S. by Alere (formerly Inverness Medical)
•  
Near & Long Term Catalysts
•  
Product Launches Using Chembio’s Patented DPP® Rapid Test Platform


 

Slide 4:
FDA Approved Rapid HIV Tests
Distributed in US Exclusively by Inverness Medical
 
•  
148% Revenue Increase in 2009 to $5.3MM

–  
20% Market Share
•  
Competitive Features

–  
CLIA Waived
–  
Two Formats

–  
99.7% Sensitivity; 99.9% Specificity
–  
Proprietary Formulation Enables 24 Month Stability

–  
Strong Marketing Partner

Marketed Ex-US Directly by Chembio through Distributors
 
 
 

 
 Slide 5:
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. Patents Issued or Pending in all major markets

 
Slide 6:
Dual Path Platform DPP® vs. Lateral Flow

•  
Dual Path Platform
–  
Chembio is a Licensor
–  
Basis for Branded & OEM Product Pipeline
•  
Lateral Flow Platform
–  
Chembio is a Licensee
•  
Alere Sells in US
•  
Ex-US Chembio Pays Alere either 8.5% or 5% Royalty


 
 Slide 7:
Pipeline from DPP® Technology
•  
2011-2012
–  
Launch of  Oral Fluid HIV Test and for Syphilis Tests & Establish Chembio DPP® Public Health Brand
–  
International DPP Revenues – Brazil
–  
Influenza Ag & Ab Tests
•  
2012-2014 –
–  
Grow Chembio DPP® Public Health Brand
–  
Launch HIV OTC, Hepatitis C, Influenza Ag & Ab
•  
2010-2014 – Participate in New Markets Via OEM Agreements, Strategic Alliances, M&A
–  
Respiratory, Cardiac, Auto-Immune
–  
Veterinary, Food, Environmental
–  
Readers
–  
Molecular Technologies

 
Slide 8:

DPP® HIV 1/2 Oral Fluid Assay
•  
$60MM/6MM Unit US Market Growing ~15%/Year
•  
International Studies Completed in 2009
•  
US Clinical Trials Commenced Q1 2010
•  
Anticipate PMA approval 2011-12
•  
OTC Opportunity

 
Slide 9:
DPP® Syphilis Screen & Confirm
•  
First POCT For Syphilis In US – Estimate $30MM Potential Market
•  
Provides Better Indication Of Active Disease
 
•  
Enables Confirmation & Treatment At POC
    •  
Pre-natal Testing

    • International Evaluation Ongoing
    • Anticipate 510(K) Clearance in 2011
 
    Developed in collaboration with the U.S. Centers for Disease Control

 
 

 
 Slide 10:
OEM Contracts with FIOCRUZ

•  
Four Products Under OEM Agreements with FIOCRUZ
–  
Following Successful $8MM Tech. Transfer Program Completed 2004-2009

•  
Two Regulatory Approvals in Brazil Received June, Sept of 2010
Initial Order in Production for Q4 2010 Shipment
Possible Additional Approval and New Products Agreement in Q4



 
Slide 11:
In Development: DPP® INFLUENZA
Multiplex Flu A & B Test & 6 Strain Immunity Test

•  
Large Established Market for Flu A&B tests
•  
Chembio’s First Antigen Detection Test with DPP
•  
Prototype Shows Improved Performance  v. Established Tests
•  
In Addition: $900,000 Contract signed Dec. 2009 with CDC for 6-band Multiplex Immune Status Test

 Slide 12:
In Development: Hepatitis-C (HCV) & HIV/HCV Comb.
Oral Fluid
•  
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 – Data Being Submitted for Publication



 
Slide 13:
$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 14:
Financial Summary
•  
Historical 2005-2009 - >33% Five CAGR Sales
–  
Became Profitable Q2-4 2009 and for full FY 2009 148% Increase in Sales to Alere, R&D Income, Controlled SG&A
 
 
•  
September 30, 2010 YTD
–  
Net Income of $632K on Total Revenue of $11.04MM
–  
Improved Gross Margins YTD from Increased R&D Income Despite Decreased Int'l. Product Sales
–  
Controlled SG&A
 
 
 
 
 

 
 
 
 
 
  Slide 15:
 
Financial Summary
 
  • Q4 2010 & FY2010 Revenue Outlook   
     - Anticipate > $15MM in Total Revenues vs. $13.8MM in 2009
     - CDC Grants to States Improving.  Anticipate Q4'10 Revenues from Alere of at least $1.9MM in Q4 2010 compared with $1.8MM in Q4'09
     - >75% Increase in 2010 Revenues from Products Serving Africa Markets
 
  • Q4-2010 & FY2010 Operating Results Outlook
     - Strong Order Backlog should result in operating efficiencies
           - New assembly automation anc cost savings implemented
     - Impact of $1.467MM in QTDP Grants Awarded 11/1/2010
     - Oral Fluid HIV Test Clinical Trial Expenditures of at least $200K
    
 
 Slide 16:
Selected Comparative Historical Financial Results

     
For the Years Ended
 
$ (000s )     2009       2008       2007       2006  
Total Revenues
    $ 13,834     $ 11,050     $ 9,231     $ 6,503  
Cost of sales
      7,974       7,198       6,435       4,894  
Gross Profit
      5,860       3,852       2,796       1,609  
          42.4 %     34.9 %     30.3 %     24.7 %
R&D Expense
      2,884       2,605       1,907       1,402  
SG&A Expense
      2,659       3,317       3,765       4,787  
Operating Income (Loss)
      317       (2,071 )     (2,876 )     (4,580 )
Other Inc. (Expense)
      (8 )     122       249       (415 )
Net Income (Loss) - Stkhldrs
      309       (1,949 )     (2,627 )     (4,995 )
Pref. Stock Expenses
      -       -       5,645       3,210  
Net Loss
    $ 309     $ (1,949 )   $ (8,272 )   $ (8,205 )
Net Income (Loss) - per Share
    $ 0.00     $ (0.03 )   $ (0.57 )   $ (0.80 )
Avg. No. Shares (Millions)
      61.946       61.267       14.608       10.293  
Working capital
    $ 1,494     $ 1,664     $ 3,229     $ 5,113  
Total assets
      6,315       5,915       6,585       7,907  
Total liabilities
      3,227       3,338       2,322       2,297  
Equity (Deficit)
      3,088       2,577       4,263       (940 )
                                     



 Slide 17:


 Selected Comparative Historical Financial Results
 
   
Three Mos Ended
   
Nine Mos Ended
 
$(000s) - UNAUDITED
 
Sept 30 2010
   
Sept 30 2009
   
Sept 30 2010
   
Sept 30 2009
 
Net Product Sales
  $ 3,787     $ 3,924     $ 8,337     $ 9,245  
License & royalty revenue
    62       31       401       84  
R&D milestone and grant revenue
    657       408       2,300       954  
Total Revenues
  $ 4,506     $ 4,363     $ 11,038     $ 10,283  
Cost of sales
    2,296       2,494       5,428       6,053  
Gross Profit
    2,210       1,869       5,610       4,230  
      49.0 %     42.8 %     50.8 %     41.1 %
R&D Expense
    1,230       778       2,822       2,128  
SG&A Expense
    802       784       2,144       2,002  
Operating Income
    178       307       644       100  
Other Inc. (Expense)
    (9 )     (1 )     (11 )     (8 )
Net Loss
  $ 169     $ 306     $ 633     $ 92  
Basic earnings-per share
  $ 0.00     $ 0.00     $ 0.01     $ 0.00  
Diluted earnings-per share
  $ 0.00     $ 0.00     $ 0.01     $ 0.00  
Basic Avg. No. Shares (Millions)
    62.147       61.945       62.068       61.945  
Diluted Avg. No. Shares (Millions)
    70.547       75.366       71.074       74.938  
 
 
 

 
 Slide 18:
Selected Balance Sheet Data
 
($000s)
 
UNAUDITED
       
 Balance Sheet Data
 
Sept. '10
   
Dec. '09
 
Cash
  $ 1,336     $ 1,068  
Accts. Receivable
    2,635       1,776  
Inventories
    1,883       1,556  
Other Current Assets
    191       267  
Total Current Assets
    6,045       4,667  
Net Fixed Assets
    828       580  
Other Assets
    690       1,068  
Total Assets
    7,563       6,315  
Total Current Liab.
    3,453       3,173  
Total Other Liab.
    221       54  
Total Liabilities
    3,674       3,227  
Total Equity
    3,889       3,088  
Total Liabilities & Shareholders Equity
  $ 7,563     $ 6,315  

 
Slide 19:
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: 101
S, G&A 7
Ops. 69
R&D 18
Reg. & Clinical, QA & QC 7
 
 
 
 

 
 
 
Slide 20:

CEMI Selected Share Data
Ticker Symbol (OTCBB)
CEMI
   
Price 10/29/10
$0.255
   
52 Week High
$0.390
   
52 Week Low
$0.159
   
Outstanding Shares (MM)
       62.2
   
Market Capitalization
$15.9
   
Fully Diluted (FD) Shares
       70.5
   
Management Holding-FD
       11.3
   
Average Volume (3 Mos)
54,000
   
Options and Warrants (MM)
 
Avg. Ex. Price
Options (3.95MM held by mgmt. & board)
5.71
$0.168
 
Warrants  - Exp. Dates
     
10/6/2011
2.54
$0.475
 
2/5/2012
0.07
$0.810
 
Total Warrants
2.61
   
Total Options & Warrants
8.32
   


 Slide 21:
SUMMARY

www.chembio.com

•  
Top Line Growth for last 5 Years; Became Profitable in 2009 & through 9/30/2010 YTD
•  
Platform Point of Care Technology DPP®
–  
Robust DPP ®Product Pipeline for Branded & OEM Products
–  
Licensing Revenues
•  
Anticipated Near and Long Term Growth Catalysts from New Collaborations, Product Launches, Regulatory Submissions & Approvals