EX-99.1 2 ex99_1.htm TEXT OF PRESENTATION ex99_1.htm


Exhibit 99.1 - Text version of Presentation
 
 





 
Annual Meeting of Shareholders
June 3, 2009

 
SLIDE - 1

 


Forward Looking Statement
 
Statements contained herein that are not historical facts may be 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 - 2

 

Selected Four Year Comparative Results
23% CAGR of Sales: 307% Incr. Gross Margin $s
 

$(000s)      
2008
   
2007
   
2006
   
2005
 
Total Revenues
    $ 11,050     $ 9,231     $ 6,502     $ 3,941  
                                     
Cost of sales
      7,198       6,435       4,894       2,996  
                                     
Gross Profit
      3,852       2,796       1,608       945  
          34.9 %     30.3 %     24.7 %     24.0 %
                                     
R&D Exp.
      2,605       1,907       1,401       1,365  
SG&A Exp.
      3,317       3,765       4,787       2,878  
Operating Loss
      (2,071 )     (2,876 )     (4,580 )     (3,298 )
                                     
Net Loss
      (1,949 )     (2,627 )     (4,995 )     (3,252 )
                                     
Pref. Stock Exp.
      -       5,645       3,210       3,517  
                                     
Net Loss
    $ (1,949 )   $ (8,272 )   $ (8,205 )   $ (6,769 )
Loss per Share
    $ (0.03 )   $ (0.57 )   $ (0.80 )   $ (0.88 )
Avg. No. Shares
      61,266,954       14,608,478       10,293,168       7,705,782  
                                     
Working capital
    $ 1,664     $ 3,229     $ 5,113     $ 4,708  
Total assets
      5,915       6,585       7,907       7,075  
Total liabilities
      3,338       2,322       2,297       1,964  
Equity (Deficit)
      2,577       4,263       (940 )     1,053  


 
SLIDE - 3

 


Selected Q1 Financial Results
•  
Gross Margin $s Increased 20%
•  
SG&A Decreased 33.6%
•  
Operating Loss Decreased 60%
•  
Cash stabilized

 

3 Mos. Ended 
   
3/31/2009
   
3/31/2008
 
               
$(000s)                
Net sales
    $ 2,269     $ 2,238  
R&D Income
      276       127  
Total Revenues
      2,546       2,365  
                     
Cost of sales
      1,547       1,532  
Gross Profit
      999       833  
          39.2 %     35.2 %
R&D Exp.
      647       626  
SG&A Exp.
      676       1,018  
Operating Loss
      (324 )     (812 )
                     
Other Inc. (Exp.)
      (1 )     13  
                     
Net Loss
    $ (325 )   $ (798 )
EPS
    $ (0.005 )   $ (0.013 )
                     
Balance Sheet Data:
   
3/31/09
   
12/31/08
 
Shs. Outstndg.
      61,944,901       61,949,901  
Working Capital
    $ 1,334     $ 1,664  
Total Assets
    $ 5,697     $ 5,915  
Total Liabilities
    $ 3,429     $ 3,338  
Shareholders Equity
    $ 2,268     $ 2,577  






 
SLIDE - 4

 
Organization & Management Team
Lawrence Siebert, President
Richard Larkin, CFO
Javan Esfandiari, Sr. VP, R&D
Rick Bruce, VP, Operations
Tom Ippolito, VP, Regulatory, QA/QC
Sandy Speer, Dir. Client Serv.
Dr. Gary Meller, Director
Katherine Davis, Director

Total Employment Q2- 2009 ~100
SG&A – 7
R&D – 18
Reg. & Clinical QA & QC - 7
Ops. – 69

 

 

 
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


Point of Care Test Market
•  
$5B+ 2008 Global Point of Care Test Market
–  
12.5% Compounded Annual Growth Rate (CAGR)
–  
Part of >$30B IVD Market
•  
Provide Immediate Information
–  
Simply, Accurately, Cost Effectively
•  
Enable Improved Outcomes
–  
Earlier Detection, Earlier Treatment
–  
Lower Overall Cost of Care
 
 
SLIDE - 7

 
Chembio’s Business Strategy

 Continue Improved Results of Base Business  - Primarily Comprised of Rapid HIV Tests Sold in the US and Globally
 Develop Funded Collaborations Using Our Patented Technology
 Create a Portfolio of Point of Care Tests for Infectious Diseases that Address Significant Unmet Market Needs

 
SLIDE - 8

Base Business of Rapid HIV Tests Marketed Globally

§  
Marketed Exclusively by Inverness Medical in US.
– Q1 2009 Sales to IMA Sales increased 56%
– States Adopting 2006 CDC Recommendations
§  
Sold Globally to Donor Funded Global Programs such as US' PEPFAR
(image of Inverness Sell Sheet and Image of Lateral Flow device)
 
 
SLIDE - 9

 


DPP® DUAL PATH PLATFORM
KEY DESIGN AND PERFORMANCE ADVANTAGES

•  
Independent Sample Flow Path Enables Improved Sample Control
–  
Improved Sensitivity vs. Lateral Flow
–  
Use of More Challenging Sample Types
•  
Improved Multiplexing Facilitated
–  
Direct Binding (i.e., without conjugate)
–  
Even & Uniform Delivery of Samples
•  
Freedom to Operate

 
SLIDE - 10

 


DPP® R&D PIPELINE
•  
Oral Fluid HIV
•  
Syphilis Screen & Confirm
•  
Global Health Products
•  
Hepatitis C
•  
Flu A/B Ag & Immunity Test

 
SLIDE - 11

 


DPP® HIV SCREENING TEST FOR USE WITH ORAL FLUID SAMPLES
•  
Currently Only One Oral Fluid HIV Test in US Market.
•  
Reauthorized $48B US AIDS Relief Program Evaluating to expand VCT & PMTCT in Africa
•  
Secures Participation in Rapid HIV Test with Chembio Patented Technology
•  
Does Not Compete with Chembio’s Lateral Flow Blood Tests marketed by Inverness
•  
Submitted to PEPFAR; Ready to Begin US Clinical Trials 2009-2010

 
SLIDE - 12

 


DPP® HIV SCREENING TEST FOR USE WITH ORAL FLUID SAMPLES
(Movie of DPP operation)

 
SLIDE - 13

 


DPP® R&D PIPELINE
•  
Oral Fluid HIV
•  
Syphilis Screen & Confirm
•  
Global Health Products
•  
Hepatitis C
•  
Flu A/B Ag & Immunity Tests
•  
Other

 
SLIDE - 14

 


DPP® SYPHILIS SCREEN & CONFIRM

•  
12MM New Cases/Yr. -250,000 in US and EU
•  
Replaces Two Time Consuming Laboratory Tests with One Single POC Test - No Rapid Tests in US
•  
Better Indication of Active Syphilis Disease
•  
Enables POC Confirmation and Treatment without return visit
•  
Developed in cooperation with CDC, currently in WHO study, FDA Pre-IDA stage

 

 
SLIDE - 15

 


DPP® R&D PIPELINE
•  
Oral Fluid HIV
•  
Syphilis Screen & Confirm
•  
Global Health Products
•  
Hepatitis C
•  
Flu A/B Ag & Immunity Tests
•  
Other

 
SLIDE - 16

 


Global Health Products
DPP Point of Care Test
 
Collaborating Organization
Tuberculosis
 
FIND
Malaria
 
FIND
HIV 1/2  Conf./Brazil
 
FIOCRUZ
Neglected Diseases: Leishmaniasis, Chagas, Leptospirosis, Leprosy
 
IDRI, NIH, FIOCRUZ

 

 
SLIDE - 17

 


DPP® R&D PIPELINE
•  
Oral Fluid HIV
•  
Syphilis Screen & Confirm
•  
Global Health Products
•  
Hepatitis C
•  
Flu A/B Ag & Immunity Tests
•  
Other

 
SLIDE - 18

 


Hepatitis C - Estimated 3MM Infections in US
Only 22% Diagnosed
•  
Chembio Participating in CDC Study with DPP(R) HCV Test
  
 
(Image of DPP test)
 
SLIDE - 19

 

 
DPP® R&D PIPELINE
•  
Oral Fluid HIV
•  
Syphilis Screen & Confirm
  
Global Health Products
•  
Hepatitis C
•  
Flu A/B Ag & Immunity Tests
•  
Other
 
 
 
SLIDE - 20

 
 
 
 
INFLUENZA: Ag DETECTION  & DIFFERENTIATED Ab IMMUNE STATUS
Ag: Current Rapid Tests Need Improved Performance
Ab: Public Health Screening for Vaccination
DPP FLU A
VS.
LATERAL FLOW  FLU A
Buffer
1.9 x 1011
1.9 x 1010
1.9 x 109
1.9 x 108
1.9 x 107
1.9 x 106
1.9 x 105
1.9 x 104
1.9 x 103
1.9 x 102
1.9 x 10
 
Reader
0
86
87
91
54
22
11
5.6
3.1
0
0
0
Visual
-
+++
+++
+++
+++
++
+
+
+
+/-
-
-
Leading Commercial lateral flow test
(visual only)
-
+++
+++
+++
++
++
+
-
-
-
-
-


 
SLIDE - 21

 

FLU IMMUNE STATUS TEST

(Several images of DPP test)

 
SLIDE - 22

 



DPP® R&D PIPELINE
•  
Oral Fluid HIV
•  
Syphilis Screen & Confirm
  
Global Health Products
•  
Hepatitis C
•  
Flu A/B Ag & Immunity Tests
•  
Other

 
SLIDE - 23

 


Other Current Projects
•  
Veterinary Applications
–  
Companion, Research, Wildlife
•  
Drug Monitoring
•  
Option of Quantitative Measurements at Point of Care with Simple Readers

 
SLIDE - 24

 


Strategy & Actions Taken to Enhance Shareholder Value

•  
Simplified Capital Structure
•  
Focused on Cash Flow
–  
Created multiple non-dilutive development contracts and grants
–  
Renegotiated payment schedules of license fees and accrued royalties
•  
Reduced Expenses
–  
Significant reduction of SG&A Expenses (including IR)
•  
Improving Manufacturing Efficiency
–  
Accelerating Product Transfers from R&D into Manufacturing
–  
Established Technical Team within R&D – ADDED PERSONNEL
–  
Invested in automation and other cost savings


 
SLIDE - 25

 
Strategy & Actions Taken to Enhance Shareholder Value
 

$(000s)      
Year Ended December
     
First Quarter
 
       
2008
   
2007
     
2009
   
2008
 
R&D Income
    $ 694     $ 466       $ 276     $ 127  
% Change
      48.9 %               117.3 %        
                                       
Gross Profit $
      3,852       2,795         999       833  
% Change
      37.8 %               19.9 %        
                                       
R&D Expenses
      2,605       1,906         647       626  
% Change
      36.7 %               3.4 %        
                                       
SG&A Wages
      1,262       1,642         237       350  
% Change
      -23.1 %               -32.3 %        
Investor Relations
      124       225         3       59  
% Change
      -44.9 %               -94.9 %        
Legal, accting
      551       643         160       259  
% Change
      -14.3 %               -38.2 %        
                                       
Total SG&A
      3,317       3,765         676       1,018  
% Change
      -11.9 %               -33.6 %        
                                       
                                       
          (000s)    
Mar-09
 
Dec-08
 
Sep-08
   
Jun-08
 
       
 
 Cash     1,292  
  1,212
    999       954  
 

 
SLIDE - 26

 


Strategy & Actions Taken to Enhance Shareholder Value
•  
New Products Completed :
–  
DPP HIV – submitted to PEPFAR (global market)
–  
DPP Syphilis Screen & Confirm – developed in cooperation with CDC, currently in WHO study, FDA Pre-IDE stage
–  
DPP HIV 1&2 Confirmatory for Brazil – Ministry of Health evaluations being completed; development continuing for all other markets
–  
DPP Canine Leishmaniasis – approval pending in Brazil
•  
Hepatitis C and Influenza Products in Development


 
SLIDE - 27

 


Strategy & Actions Taken to Enhance Shareholder Value Plan
•  
Improve Revenues and Operating Results
–  
Increased sales in base HIV test business – US and Globally
–  
New revenue streams from Brazil and other new customers
–  
Integrate automation equipment into manufacturing
•  
Sales & Marketing
–  
New DPP HIV, Syphilis and Hepatitis C products to be featured at AACC (July, Chicago) & Medica (November, Dusseldorf)  - the 2 most important industry meetings
–  
Upgrade web site and create new marketing materials for trade and investors


 
SLIDE - 28

 


Strategy & Actions Taken to Enhance Shareholder Value Plan
Our goal is to show:
  Improved fundamental performance,
  No short or medium term funding needs,
  A Profitable Base Business Manufacturing Regulated Biotech products, and
  New Products Based on our Patented POC Platform to Address POCT Market Opportunities.
We believe that achievement of these goals will result in greater returns to our shareholders.


 
SLIDE - 29

 



 
For further information please visit our web site
 
www.chembio.com
 
SLIDE - 30