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

Slide 1:
Logo
Investor Presentation
March 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
•  
2009 Total Revenues of $13.8MM - $309K Net Income v. $11.0MM Rev. - $1.9MM Net Loss in 2008
•  
Five Year Revenue CAGR of 33%
•  
148%  Revenue Increase, to $5.3MM in 2009, of FDA Approved Rapid HIV Tests  Marketed in U.S. by Inverness Medical
•  
Developing New OEM & Branded Product Pipeline Utilizing Chembio’s Patented DPP® Technology



 
 
 

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:
$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:

2008 Revenue Composition
Lower ASP International Revs. 3x US

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:

2009 Revenue Composition
US & International Sales Nearly Even
2009 – Total Revenue $13,834,248

LF-HIV, Int’l - $5,552,947 (40%), LF-HIV-U.S. - $5,240,000 (38%), Other - $960,016 (7%), R&D $1,339,859 (10%), DPP $619,530 (6%), Royalty Income $121,896 (1%).


 
 
 

Slide 10:

FDA Approved Rapid HIV Tests
Distributed in US Exclusively by Inverness Medical
•  
148% YTD Increase in 2009 -$5.3MM v. $2.1MM

–  
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® HIV 1/2 Oral Fluid Assay


•  
$60MM/6MM Units
20% US Market Growth in 2009
•  
International Studies Completed in 2009
•  
US Clinical Trials Commencing Q1 2010
•  
Anticipate PMA approval mid-2011
•  
OTC Opportunity
 
 
 

Slide 15:

DPP® Syphilis Screen & Confirm
•  
First POCT For Syphilis In US – Estimate $30MM Market
•  
Provides Better Indication Of Active Disease

•  
Enables Confirmation & Treatment At POC
•  
Pre-natal Testing

• International Evaluation Ongoing
• Anticipate 510(K) Clearance in Early 2011
 

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

 
 
 

Slide 16:
In Development: DPP® INFLUENZA
Multiplex Flu A & B Test & 6 Strain Immunity Test

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


Slide 17:

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 – Expect Data in First Half 2010

 
 
 

Slide 18:
OEM & Contract R&D

•  
Four Products Under OEM Agreements with Bio-Manguinhos, Brazil
–  
Completed $8MM Tech. Transfer Program with Chembio 2004-2009
•  
Anticipate Regulatory Approval in Brazil of Three Products During First Half 2010
–  
Potential Annual Revenues of ~$3MM 2010-2012 (total $12MM)

 

 
 

Slide 19:

DPP® Contract R&D Programs

DPP® Product; Contractor
Development Contract/Grant Amount
Status
Confidential Multiplex Test; Bio-Rad Laboratories, Inc.
April 2008-June 2010; N/A
Two Year Development Phase being Completed First Half 2010; begin regulatory phase
Multiplex Influenza Test; U.S. Centers for Disease Control
December 2009-October 2010;
$900,000
Development Plan approved and project proceeding
Leptospirosis test;
National Institutes of Health Grant
June 2009-May 2012; $3MM
Development program proceeding


 
 
 
 

Slide 20:
OEM Products Pipeline

See image in PDF
 
 

Slide 21:


Chembio Branded Products Pipeline

See image in PDF



 
 

Slide 22:
Selected Comparative Historical Financial Results
2005-2008 and 9 Mos. of 2009
 
 
     
 
For the Years Ended 
  
 
(000s)
  
2009
      
2008
      
2007
      
2006
      
2005
  
Total Revenues
    
$
13,834
    
$
11,050
    
$
9,231
    
$
6,503
    
$
3,941
  
Cost of sales
      
7,974
      
7,198
      
6,435
      
4,894
      
2,996
  
Gross Profit
      
5,860
      
3,852
      
2,796
      
1,609
      
945
  
         
42.4
%
    
34.9
%
    
30.3
%
    
24.7
%
    
24.0
%
R&D Expense
      
2,884
      
2,605
      
1,907
      
1,402
      
1,365
  
SG&A Expense
      
2,659
      
3,317
      
3,765
      
4,787
      
2,878
  
Operating Income (Loss)
      
317
      
(2,071
)
    
(2,876
)
    
(4,580
)
    
(3,298
)
Other Inc. (Expense)
      
(8
)
    
122
      
249
      
(415
)
    
46
  
Net Income (Loss) - Stkhldrs
      
309
      
(1,949
)
    
(2,627
)
    
(4,995
)
    
(3,252
)
Pref. Stock Expenses
      
-
      
-
      
5,645
      
3,210
      
3,517
  
Net Income Loss
    
$
309
    
$
(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)
      
61.946
      
61.267
      
14.608
      
10.293
      
7.705
  
Working capital
    
$
1,494
    
$
1,664
    
$
3,229
    
$
5,113
    
$
831
  
Total assets
      
6,315
      
5,915
      
6,585
      
7,907
      
3,016
  
Total liabilities
      
3,227
      
3,338
      
2,322
      
2,297
      
1,964
  
Equity (Deficit)
      
3,088
      
2,577
      
4,263
      
(940
)
    
1,053
  


 
 

Slide 23:

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

     
Three Mos Ended
      
 
(000s)
    
 
Dec. 30, 2009
    
Dec. 30, 2008
      
Total Revenues
    
$
3,551
    
$
2,451
      
Cost of sales
      
1,920
      
1,836
      
Gross Profit
      
1,631
      
615
      
         
45.9
%
    
25.1
%
  
 
R&D Expense
      
756
      
653
      
SG&A Expense
      
657
      
620
      
Operating Income (Loss)
      
218
      
(658
)
  
 
Other Inc. (Expense)
      
(1
)
    
108
      
Net Income (Loss) - Stkhldrs
      
217
      
(550
)
  
 
Pref. Stock Expenses
      
-
      
-
      
Net Income Loss
    
$
217
    
$
(550
)
  
 
Net Income (Loss) - per Share
    
$
0.00
    
$
(0.00
)
  
 
Avg. No. Shares (Millions)
      
61.951
      
61.945
      
Working capital
    
$
1,494
    
$
1,664
      
Total assets
      
6,315
      
5,915
      
Total liabilities
      
3,227
      
3,338
      
Equity (Deficit)
      
3,088
      
2,577
      



 
 
 

Slide 24:

Selected Balance Sheet Data
($000s)
            
Balance Sheet Data
  
Dec '09
    
Dec. '08
  
Cash
    
$1,068
      
$1,212
  
Accts. Receivable
    
1,776
      
809
  
Inventories
    
1,556
      
1,819
  
Other Current Assets
    
267
      
225
  
Total Current Assets
    
4,667
      
4,066
  
Net Fixed Assets
    
580
      
881
  
Other Assets
    
1,068
      
968
  
Total Assets
    
6,315
      
5,915
  
Total Current Liab.
    
3,173
      
2,402
  
Total Other Liab.
    
54
      
936
  
     Total Liabilities
    
3,227
      
3,338
  
Total Equity
    
3,088
      
2,577
  
Total Liabilities & Shareholders Equity
    
6,315
      
5,915
  



 
 
 

Slide 25:

CEMI Selected Share Data
As of 2/28/10
Stock data as of 2/28/10 (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
    
 
10/5/11
2.64
$0.48
 
2/5/12
.07
$0.81
Total Warrants
  
2.71
  
       
Total Options & Warrants
8.46
  
       



 
 
 

Slide 26:
 
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www.chembio.com