EX-99.2 3 ex99_2.htm EXHIBIT 99.2 INVESTOR PRESENTATION ex99_2.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
•  
Current POCTs for HIV, Syphilis & Other Infectious Diseases, applicable to many other markets
•  
Branded & Private Label (OEM) Strategy
•  
Enabled by Patented Dual Path Platform (DPP®)
•  
Four products approved in Brazil 2010-11 now being launched by Brazilian OEM partner
•  
FDA & USDA Approved Leased Manufacturing Facility in Medford, NY
•  
130 Employees




Slide 4

Financial Overview

·  
Five Year Compounded Annual Revenue Growth of 33%
·  
Gross Margin Expansion Actual and % Sales
·  
2006: $1.60MM -           25%
·  
2010: $8.10MM -           48%
·  
2010 6 Mos. YTD -       $3.40MM -                                                                      52%
·  
2011 6 Mos. YTD -      $3.98MM -            55%
·  
Profitable 2009, 2010 and 2011YTD

(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 Serve Crucial Public Health Objectives
o  
Chembio Pursuing FDA Approval of Sure Check® HIV Test for Self Testing by Consumers
•  
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
•  
Visual and/or Instrument Read-Out
•  
Patents issued in several global markets including U.S., UK, Australia, Eurasia and China
o  
Additional DPP® Patents Pending in the U.S. and many foreign countries

(see graphics)
 
Slide 7

Pipeline of Chembio-Branded Products Complemented by Current & Future OEM Programs

Current OEM/Licensees:  Fiocruz (Brazil), BIORAD, Alere
Potential Future OEM/License Areas: Infectious Diseases, Veterinary Wellness

Chembio Branded Products in Clinical Trials
DPP® HIV SCREENING TEST – DPP® SYPHILIS SCREEN & CONFIRM – SURE CHECK® HIV OTC – OTHER INFECTIOUS DISEASE PRODUCTS


Slide 8

Lateral Flow Rapid HIV Tests

·  
>20% of 1.1MM HIV+ Individuals in U.S. Not Aware of their Status
·  
Products Sold in US Professional Market by Alere Inc. (NYSE:ALR) as Clearview® brand
o  
10-Year Exclusive Agreement through Sept. 2016
o  
42% Increase YTD v. 2010
·  
Ex-US Under Chembio Brands (STAT PAK® & SURE CHECK®)



Slide 9

U.S. Rapid HIV Test Market


 
Clearview
Complete
Clearview
STAT PAK®
DPP® HIV Screen
OraQuick
Uni-Gold
 
 (See Graphic)
 
 (See Graphic)
 
 (See Graphic)
 
 (See Graphic)
 
(See Graphic)
 
 
Manufacturer
Chembio
Chembio
Chembio
Orasure Technologies, Bethlehem PA
Trinity Biotech, Dublin Ireland
Current or Planned Distribution
Private Label for Alere Direct & Distribution
Private Label for Alere Direct & Distribution
Direct & Distributors
Direct sales force
Direct sales force & distributors
FDA Approval Date
2006
2006
Clinical trials
2003
2003
Technology
Lateral Flow
Lateral Flow
Dual Path Platform (DPP®)
Lateral Flow
Lateral Flow
Est. US Market Shr.
8%
12%
N/A
65%
15%
FDA Sensitivity
99.7%
99.7%
TBD
99.3%OF/99.6% WB
100%
FDA Specificity
99.9%
99.9%
TBD
99.8%OF/100% WB
99.7%
Features
          
Sample Types
All Blood Matrices
All Blood Matrices
Blood & Oral Fluid Claims being pursued
Oral Fluid and all blood matrices except serum
All Blood Matrices
True IgG Control
Y
Y
Y
Y
N
Sample Size
(in microliters)
<5
<5
<5
<5
40
HIV-2
Y
Y
 Y
Y
N



Slide 10

Pipeline: Chembio-Branded Products Anticipated Timelines – US Market


Product
2011
2012
Est. Current & Potential U.S. Market Size
DPP® HIV Screen
Clinical Trials Commenced 2010, Completing  in Q4; Modular PMA Submissions in Q1’11, Q3’11 and Q4’11
FDA Approval, CLIA waiver, US Market Launch
$70MM/$150MM
US POCT Market Developed into 7MM Unit Market since 2003
DPP® Syphilis Screen & Confirm
Clinical Trials Q3-4’11; 510(K) Submission
FDA Clearance & US Market Launch – Q3’11
NA/$50MM
69MM Syphilis tests performed in US; 50MM Clinical; Assumes 20% convert to POCT
Sure Check® HIV OTC
Product Already Approved for Professional Use which is pre-requisite; Submitting IDE for Self Testing Protocol
Phase II Clinical Trials in 2012-2013
NA/$150MM
Assumes $30 OTC Test


Significant International Market Opportunities As Well



Slide 11

Pipeline: OEM Contracts with FIOCRUZ Brazil
Anticipate Minimum of $3MM in 2011 Revenues v. $.6MM in 2010

Contract
2010
2011
2012
DPP® HIV Screening
Approved,
Commercial Sales
Commercial Sales
Commercial Sales
DPP® HIV Confirmatory
Approved
Commercial Sales
Commercial Sales
DPP® Syphilis Treponemal
Agreement Signed
December 2010
Approved Q1 ‘11, Commercial Sales
Commercial Sales
DPP® Syphilis Treponemal/
Non-Treponemal
Submission, Approval
Commercial Sales
DPP® Canine Leishmaniasis
Submitted
Approved Q1’11, Commercial Sales
Commercial Sales
DPP® Leptospirosis
 
Submitted, Approval, Commercial Sales
Commercial Sales



Slide 12

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
$2.4MM, 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 13

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 14

Financial Summary- First Quarter 2008-2011
·  
Steady increases in Revenue and Gross Profit
·  
Increased R&D expense in 2011YTD driven partially by increased Clinical Trials expense
·  
Profitable Q2-2011 and YTD


(See Graphic)




Slide 15
Selected Comparative Operating Statement Items – 2010 vs. 2011

 
3mos. June 30, 2011
  
3mos. June 30, 2010
  
June 30,
2011-YTD
  
June 30,
2010-YTD
  
December 31, 2010
  
Net Product Revenues
 $     2,974,379
  
 $     2,335,665
  
 $     5,989,442
  
 $     4,550,562
  
 $      13,516,359
  
Non-Product Revenues
            639,772
  
        1,413,777
  
        1,260,390
  
        1,982,296
  
           3,188,344
  
TOTAL REVENUES
 $ 3,614,151
  
 $ 3,419,442
  
 $ 7,249,832
  
 $ 6,532,858
  
 $ 16,704,703
  
GROSS MARGIN
    2,050,278
 57%
    2,094,966
61%
    3,976,620
55%
    3,401,340
52%
      8,100,699
48%
OPERATING COSTS:
                    
Research and development expenses
        1,164,872
32%
            791,596
23%
        2,455,014
34%
        1,592,354
24%
           2,586,308
15%
Selling, general and administrative expense
            688,259
19%
            680,014
20%
        1,463,630
20%
        1,341,862
21%
           2,940,721
18%
 
    1,853,131
  
    1,471,610
  
    3,918,644
  
    2,934,216
  
      5,527,029
  
INCOME FROM OPERATIONS
       197,147
  
       623,356
  
         57,976
  
       467,124
  
      2,573,670
  
OTHER INCOME (EXPENSES):
         (2,308)
  
         (1,439)
  
         (5,434)
  
         (2,533)
  
         (60,326)
  
NET INCOME
       194,839
5%
       621,917
18%
         52,542
1%
       464,591
7%
      2,513,344
15%





Slide 16


Revenue Growth by Category: 2009 vs. 2010

(see graphic)


Slide 17

Revenue Growth by Category: Q2’10 YTD vs. Q2’11 YTD
(see graphic)

Slide 18

Selected Balance Sheet Data

($ in millions)
June.’11
Dec. '10
Dec. '09
Dec. ‘08
Cash
$2,139
2,136
1,068
1,212
Accounts Receivable
1,643
3,946
1,776
809
Inventories
2,917
1,349
1,556
1,819
Total Current Assets
6,914
205
4,667
4,068
Net Fixed Assets
778
813
580
881
Other Assets
743
636
1,068
968
Total Assets
$8,435
9,086
6,315
5,915
         
Total Current Liabilities
2,079
3,076
3,173
2,402
Total Liabilities
2,238
3,277
3,227
3,338
         
Total Equity
6,197
5,809
3,088
2,577
         
Total Liabilities & Shareholders Equity
$8,435
9,086
6,315
5,915


 
Slide 19

Anticipated Milestones 2011
•  
Clinical & Regulatory Programs for Branded Products
‐  
HIV PMA Modular Submissions
‐  
Syphilis Clinical Trials
‐  
Sure Check HIV OTC IDE
•  
Commercialization of OEM Products
‐  
2011 FIOCRUZ
‐  
2012 BIO RAD

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



Slide 20

Leadership

Executive
Joined Company*
Lawrence Siebert,  Chairman & CEO
2002
Richard Larkin, CFO
2003
Javan Esfandiari, SVP R&D
2000
Tom Ippolito, VP Regulatory, Clinical, QA/QC
2005
Rick Bruce, VP Operations
2000
Independent Directors
Joined Board
Gary Meller, MD, MBA
2005
Kathy Davis, MBA
2007
Barbara DeBuono, MD MPH
2011
Peter Kissinger, Ph.D
2011


Slide 21


TOTAL EMPLOYMENT Approx. 130

Research and Development – 24
Regulatory and Clinical QA & QC – 11
Sales, General & Administration – 8
Operations- 87

Fully Integrated FDA & USDA Approved Development & Manufacturing in 24,000 S/F Leased Facility in Medford, NY



Slide 22

Potential Impact of OEM & Branded Products Revenue*

(See Graphic)


 
Slide 23

CEMI Selected Share Data
Ticker Symbol (OTC-QB)
CEMI.QB
Price 7/29/2011
$0.42
52-Week High
$0.580
52-Week Low
$0.210
Outstanding Shares
63.3
Market Capitalization
$26.6
Fully Diluted Shares
69.8
Management Holding
11.6
Average Daily Volume (3 months)
60,000

Options and Warrants
Amt.
Avg. Ex. Price
Options
(3.89MM held by mgmt. & board)
5.42
$0.192
Warrants (MM)-Exp. Dates
 
  
10/06/2011
1.17
$0.454
02/05/2012
0.07
$0.810
Total Warrants (MM)
1.24
$0.475
Total Options & Warrants (MM)
2.41
$0.245


(See graphics)


Slide 24

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

·  
Improved Performance Based on Multiple Studies
·  
US Clinical Trials Being Completed in 2011
o  
Modular PMA Submission in 2011
o  
Anticipated Approval 2012
·  
OTC Opportunity


(See graphic)


Slide 25

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 26

SURE CHECK® HIV OTC IDE Submission 2011; Clinical Trials Beginning 2012
•  
Patented All-In-One Barrel Device
•  
Increasing Market Acceptance in Professional Market (Clearview by Alere)
•  
Alternative to Less Sensitive Oral Fluid Product from Only Competitor
•  
Potential Clinical Trials, Submission to FDA, and Approval in 2012-14

(See graphic)