EX-99.3 4 ex99_3.htm EXHIBIT 99.3 INVESTOR PRESENTATION ex99_3.htm  




RAPID Tests for EARLIER Treatment

Investor Presentation

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

•  
Chembio Overview
•  
Develops, Manufactures and Markets Rapid Point of Care Test (POCT) Products Serving Global Markets
•  
Diverse & Growing Pipeline of Proprietary Products
•  
Fully Integrated FDA Approved Manufacturing Facility in NY
•  
Record Financial Results  2009 & 2010


Slide 4

Financial Overview

·  
Five Year Compounded Annual Revenue Growth of 33%
·  
Simplified Capital Structure 12/2007
·  
Retired ~$2MM debt Jan. 2009 – Jan. 2011
·  
Record Revenues and Improved Operating Results Year after Year
·  
Near and Long-Term Growth Catalysts

(See graph)

Slide 5

POCT’s – A Growing Global Market

•  
$7B Global Point-of-Care Test (POCT) Market
•  
Fastest Growing Segment of $39.5B In-Vitro Diagnostics Market
•  
POCTs for HIV, Syphilis, HCV and other STDs Serve Crucial Public Health Objectives
•  
Other Important POCT Markets
o  
Infectious Diseases, Cardiac Markers, Companion Animal, OTC, Allergy


Slide 6

DUAL PATH PLATFORM (DPP®) Chembio’s Proprietary POCT Technology

•  
Independent Sample Flow Path Enables Improved Sensitivity & Use of More Challenging Sample Types
•  
Improved Multiplexing Facilitated by Direct Binding, Uniform Delivery of Samples
•  
U.S. patents, and patents in China, Malaysia, Eurasia, Mexico, Singapore, and the U.K.
o  
Additional DPP®   Patents in the U.S. and many foreign countries
o  
Patents have also been filed on extensions to the DPP®  product line

(see graphics)

Slide 7

Chembio-Branded Public Health Foundation Complemented by OEM and/or License Programs

Current OEM/Licensees:  Fiocruz (Brazil), BIORAD
Anticipated OEM/License Areas: Infectious Diseases, Veterinary

HIV SCREEN – HCV AB-AG DUAL DPP-  SYPHILIS - INFLUENZA






Slide 8

Lateral Flow Rapid HIV Tests

·  
25% of 1.1MM HIV+ Individuals in U.S. Not Aware of their Status
·  
US Rapid HIV Test Market Growth Continuing as States Implement CDC Testing Recommendation
·  
Only Two Other CLIA-waived Products
·  
Products Sold Under Chembio Brands (STAT PAK® & SURE CHECK®)ex-US and by Alere, Inc. (formerly Inverness) in US.




Slide 9

Pipeline:  Chembio-Branded DPP® Products Anticipated Timelines – US Market



 
2011
2012
US Market
DPP® HIV Oral Fluid
Clinical Trials Commenced 2010, Completing  Q1 & 2; Modular Submissions in Q1, 2 & 3
FDA Approval, CLIA waiver, US Market Launch
$70MM
DPP® Syphilis Screen & Confirm
Completing Validation Q1; Clinical Trials Q2-4
FDA Clearance & US Market Launch – Q1-2
$30MM
Dual DPP ® HCV Ag/Ab
R&D
R&D
TBD
DPP® Influenza A/B Antigen Detection
Completing R&D Q1, Validation Q2; Clinical Trials Q3-4
FDA Clearance & US Market Launch – Q1-2
$200MM

Significant International Market Opportunities As Well






Slide 10

Pipeline: OEM Contracts with FIOCRUZ Brazil Anticipated Timelines


 
Contract
2010
2011
Minimum Product Sales Req. to Complete Tech Transfer*
DPP® HIV Screening
Approved,
Commercial Sales
Commercial Sales
$8.8MM
DPP® HIV Confirmatory
Approved
Commercial Sales
$4.7MM
DPP® Syphilis Treponemal
Agreement Signed
December 2010
Approval, Commercial Sales
$7.4MM
DPP® Syphilis Treponemal/
Non-Treponemal
Submission, Approval
DPP® Canine Leishmaniasis
Submitted
Approved Q1'11, Commercial Sales
$2.1MM
DPP® Leptospirosis
Submission pending
Submission, Approval, Commercial Sales
$0.4MM
 
*Not a guaranteed minimum except for purposes of technology transfer



Slide 11

Pipeline: Other Products

Project
Activity
Multiplex DPP® Product Developed for & Licensed to Bio-Rad Laboratories, Inc.
Development completed. Anticipate CE Mark EOY 2011 – Launch EU early 2012.  Manufacturing by Bio-Rad. Royalties Upon Commercial Sales
Multiplex Influenza Immune Status Product Developed for Battelle/CDC
Prototype Development Completed;  Prototype products being evaluated at CDC. Additional development work under consideration.
NIH Phase II Grant – Leptospirosis
$2.9MM 3 Year Grant awarded 6/2009.  Prototype Developed.  Further reagent discovery underway.  Approximately $1.7MM funding remaining in 2011 and 2012 if renewed as anticipated.  Chembio is principal grantee.
NIH Phase II Grant –
Tuberculosis
$2.9MM, 3 Year Grant awarded Effective 3/1/2011.  Prototype Developed. Planning Multi-site Evaluations and Optimization, Validation and Commercialization.  Chembio is principal grantee.
Veterinary Diagnostic Applications
Preliminary Discussions
Platform Enhancements
Buffer Integration and “Dual DPP®” projects in progress
 
 
 
Slide 12

Financial Summary

FY 2008-2010 Results
•  
Record Revenues and Earnings
•  
Improving Gross Margins
•  
Controlled Operating Expenses
•  
Operating Cash Flow Strengthened Balance Sheet

(See Graphic)


Slide 13

Financial Summary- First Quarter 2008-2011
·  
Steady increases in Revenue and Gross Profit
·  
Increased R&D expense in Q1’11 driven partially by increased Clinical Trials expense
·  
Steadily improving new loss in Q1


(See Graphic)


Slide 14

Revenue Growth by Category: 2009 vs. 2010

(see graphic)



Slide 15

Revenue Growth by Category: Q1’10 vs. Q1’11

(see graphic)


Slide 16

Selected Balance Sheet Data

($ in millions)
 
Mar.’11
   
Dec. '10
   
Dec. '09
   
Dec. ‘08
 
Cash
  $ 2,797       2,136       1,068       1,212  
Accounts Receivable
    1,727       3,946       1,776       809  
Inventories
    1,592       1,349       1,556       1,819  
Total Current Assets
    176       205       4,667       4,068  
Net Fixed Assets
    772       813       580       881  
Other Assets
    611       636       1,068       968  
Total Assets
  $ 7,675       9,086       6,315       5,915  
                                 
Total Current Liabilities
    1,760       3,076       3,173       2,402  
Total Liabilities
    1,939       3,277       3,227       3,338  
                                 
Total Equity
    5,736       5,809       3,088       2,577  
                                 
Total Liabilities & Shareholders Equity
    7,675       9,086       6,315       5,915  




Slide 17

Anticipated Milestones 2011
•  
Clinical & Regulatory Programs for Branded Products
‐  
HIV PMA Modular Submissions
‐  
Syphilis Clinical Trials
‐  
Influenza Clinical Trials
•  
Four OEM Product Approvals for and Product Sales to FIOCRUZ

•  
New R&D & OEM Product Agreements
•  
Continued US Lateral Flow HIV Test Market Share Gains & Potential New International Market Opportunities



Slide 18

Potential Impact of OEM & Branded Products on Revenue

(See graphic)



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 Approx. 100

Research and Development – 18
Regulatory and Clinical QA & QC – 7
Sales, General & Administration – 7
Operations- 69


Slide 20

CEMI Selected Share Data
Ticker Symbol (OTC-QB)
CEMI.QB
Price 4/29/2011
$0.48
52-Week High
$0.580
52-Week Low
$0.159
Outstanding Shares
63.1
Market Capitalization
$36.6
Fully Diluted Shares
70.2
Management Holding
11.2
Average Daily Volume (3 months)
105,000
 
 

 
Options and Warrants
Amt.
Avg. Ex. Price
Options
(3.64MM held by mgmt. & board)
5.21
$0.166
Warrants
(1.75 expire 10/2011)
1.83
$0.503
Total Options & Warrants
8.24
.267



(See graphics)


Slide 21

Additional Slides (Appendix)

 
March 31,
2011
 
March 31,
2010
 
December 31,
2010
 
December 31,
2009
 
December 31,
2008
 
                     
TOTAL REVENUES
 $ 3,635,681
 
 $ 2,783,415
 
 $ 16,704,703
 
 $ 13,834,248
 
 $ 11,049,571
 
                     
GROSS MARGIN
    1,926,342
53%
    1,306,374
47%
      8,100,699
48%
      5,860,405
42%
      3,851,721
35%
                     
OPERATING COSTS:
                   
                     
Research and development expenses
        1,290,142
35%
            800,758
29%
           2,586,308
15%
           2,883,696
21%
           2,605,343
24%
Selling, general and administrative expense
            775,371
21%
            661,848
24%
           2,940,721
18%
           2,659,382
19%
           3,317,046
30%
 
    2,065,513
 
    1,462,606
 
      5,527,029
 
      5,543,078
 
      5,922,389
 
                     
INCOME (LOSS) FROM OPERATIONS
     (139,171)
 
     (156,232)
 
      2,573,670
 
         317,327
 
    (2,070,668)
 
                     
OTHER INCOME (EXPENSES):
         (3,126)
 
         (1,094)
 
         (60,326)
 
           (8,267)
 
         121,898
 
                     
NET INCOME (LOSS)
     (142,297)
-4%
     (157,326)
-6%
      2,513,344
15%
         309,060
2%
    (1,948,770)
-18%



Slide 22

DPP® HIV Screening Assay For Use with Oral Fluid or Blood Samples

·  
Improved Performance vs. Only Oral Fluid Test Based on Multiple Studies
·  
OTC Opportunity
·  
US Clinical Trials Being Completed Q1-2 2011
o  
Modular PMA Submission in Q1, 2, 3
o  
Anticipated Approval 2012


(See graphic)


Slide 23

DPP® Syphilis Screen & Confirm

•  
First POCT in US for Syphilis
•  
All Pregnant Women Tested for Syphilis
•  
Current Laboratory Tests Inadequate
•  
Enables Confirmation & Treatment At POC
•  
International Evaluation Ongoing in China
•  
Anticipate FDA Clearance in early 2012

(See graphic)


 
Slide 24

DPP® INFLUENZA Multiplex Flu A & B Test

•  
Large Established Market for Flu A&B tests
•  
Chembio’s First Antigen Detection Test with DPP®
•  
Prototype Shows Improved Performance vs. Established Tests
•  
Anticipate FDA Clearance mid-2012



Slide 25

Hepatitis-C (HCV)

•  
Estimated 3MM HCV Infections in US
•  
No HCV Point-of-Care Test in US Testing for Antigen (indicating active disease)
•  
Chembio Participating in Various Studies to Assess Prototype Performance
•  
R&D Continuing in 2011