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
•  
Current POCTs for HIV, Syphilis & Other Infectious Diseases, applicable to many other markets
•  
Base Business Utilizes In-Licensed Lateral Flow Technology
•  
New Business Based on Chembio’s Dual Path Platform (DPP®)
•  
Branded & Private Label (OEM) Strategy
•  
Five DPP® POCTS Approved in Brazil 2010-11 Now  Being Launched by Brazilian Ministry of Health through its affiliate Oswaldo Cruz Foundation, Chembio’s OEM customer.
•  
FDA & USDA Approved Leased Manufacturing Facility in Medford, NY
•  
140 Employees


Slide 4

Financial Overview

·  
Five Year Compounded Annual Revenue Growth of 33%
·  
Gross Margin Expansion
o  
Higher ASP’s in US
o  
Scale up Efficiencies
·  
Increased investment in R&D pipeline
o  
DPP HIV Clinical Trials
      -   2007 Recapitalization

(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  
Professional US Rapid HIV Test Market Now ~7 Million tests annually
§  
OTC Market Opportunity for Sure Check® HIV test being pursued
o  
Chembio’s Unique Dual Band DPP® Syphilis Screen & Confirm, CE Marked October 2011
 

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

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
 
DPP® HIV SCREENING TEST – DPP® SYPHILIS SCREEN & CONFIRM – SURE CHECK® HIV OTC – SINGLE PARAMETER & MULTIPLEX INFECTIOUS DISEASE PRODUCTS


Slide 8

Lateral Flow Rapid HIV Tests

·  
25% 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 based on ASP sharing
o  
9 Month Sales $5.39 Million, a 52% increase YTD v. comparable 2010 period
·  
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
N

 
Slide 10

Pipeline: Chembio-Branded Products Anticipated Timelines – US Market

CLINICAL TRIALS/REGULATORY SUBMISSIONS

REGULATORY APPROVAL OR CLEARANCE/COMMERCIAL SALES


Product
2011
2012
Est. Current & Potential U.S. Market Size
DPP® HIV Screen
Anticipated Completing Clinical Trials December; PMA Module I Submitted and responded. PMA Module II submitted in October
Respond to Module II & Submit Module III Q1. FDA Approval,  CLIA waiver, US Market Launch
$70MM/$150MM
US POCT Market Developed into 7MM Unit Market since 2003
DPP® Syphilis Screen & Confirm
CE Marking Granted October; Establishing EU Distribution;  Clinical Trials Commenced for US FDA 510(K) Submission
 Launch in EU ; Complete clinical trials in US & Submit 510(K) to FDA for Clearance and US Launch
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
Complete Pre-ID Requirements and Begin Phase II Clinical Trials
NA/$150MM
Assumes $30 OTC Test







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
 
Approved Q3’11
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 Fall 2012.  Manufacturing by Bio-Rad. Royalties to Chembio upon Commercial Sales
Multiplex  DPP® Influenza Immune Status Product Developed for Battelle/CDC
Prototype Development Completed; Prototype products being evaluated at CDC. Additional development work Q4 2011 – Q1 2012.
New DPP® OEM Applications
Veterinary
Potential New DPP® Branded Products
Infectious Diseases, Women’s Health, Cervid Veterinary TB
DPP® Platform Enhancements
Buffer Integration and “DUAL DPP®” projects in progress
NIH Phase II Grant – Leptospirosis & Tuberculosis
DPP® Leptospirosis - $2.9MM 3 Year Grant awarded 6/2009.  Prototype Developed.  Further reagent discovery underway.  Approximately $1MM funding remaining as of 10/1/2011.  Chembio is principal grantee.
 
DPP® 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.


 
 
 
 
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

2010 Full Year and 9 Month 2010 & 2011 Selected Financial Results
 
 
 
   September 30, 2011-YTD       September 30, 2010- YTD    December 31, 2010  
 Net Product Revenues  $11,516,325    $8,337,133    $13,516,359  
 Non- Product Revenues     1,655,294    2,700,728    3,188,344  
 TOTAL REVENUES   13,171,619    11,037,861    16,704,703  
 GROSS MARGIN    6,647,353  50%  5,609,841  51%  8,100,699  48%
 OPERATING COSTS:            
 Research & Development Costs  3,697,309  28%  2,822,455           26%  2,586,308  15%
 Selling, general and administrative expense  2,412,867             18%  2,143,715  19%  2,940,721  18%
   6,110,176    4,966,170    5,527,029  
 INCOME FROM OPERATIONS  537,177    643,671    2,573,670  
 OTHER INCOME (EXPENSES):  (9,030)    (11,103)    (60,326)  
 NET INCOME  528,147  4%  632,568  6%  2,513,344  15%
 
 
 
(See Graphic)


Slide 15

Three Months September 2010 & 2011 Selected Financial Results


 
   3 Mos. September 30, 2011       3 Mos. September 30, 2010  
 Net Product Revenues  $5,526,883    $3,786,572  
 Non-Product Revenues   394,904    718,431  
 TOTAL REVENUES  5,921,787    4,505,003  
 GROSS MARGIN  2,670,733           45%  2,208,501  49%
 OPERATING COSTS:        
 Research and development expenses  1,242,295  21%  1,230,100  27%
 Selling, general and adminstrative expense    949,237  16%  801,854  18%
   2,191,532    2,031,954  
 INCOME FROM OPERATIONS   479,201    176,547  
 OTHER INCOME (EXPENSES):     (3,596)    (8,571)  
 NET INCOME    475,605  8%  167,976               4%
 

(See Graphic)


Slide 16


Revenue Growth by Category: 2009 vs. 2010

(see graphic)


Slide 17

Revenue Growth by Category: Q3’11 YTD vs. Q3’10 YTD
(see graphic)

Slide 18

Selected Balance Sheet Data

($ in millions)
Sept’11
Dec. '10
Dec. '09
Cash
$3,045
2,136
1,068
Accounts Receivable
2,658
3,946
1,776
Inventories
2,588
1,349
1,556
Total Current Assets
8,840
205
4,667
Net Fixed Assets
849
813
580
Other Assets
770
636
1,068
Total Assets
$10,099
9,086
6,315
       
Total Current Liabilities
3,199
3,076
3,173
Total Liabilities
3,345
3,277
3,227
       
Total Equity
6,754
5,809
3,088
       
Total Liabilities & Shareholders Equity
$10,099
9,086
6,315




Slide 19

Anticipated Milestones 2012

Clinical & Regulatory Programs for Branded Products
•  
Submit Module III for DPP®HIV PMA, Receive FDA PMA Approval and CLIA waiver
•  
Complete Syphilis Screen & Confirm Clinical Trials, Submit to FDA for 510(K) Clearance, Receive Clearance
•  
Complete Sure Check HIV OTC Pre-IDE, Commence Phase II Clinical Trials
•  
New Claims for Veterinary TB

Product Revenues & Operating Results
•  
Full Year of New Products launched in Brazil through FIOCRUZ
•  
Launch of DPP® Syphilis Screen & Confirm in Europe
•  
Continued US Lateral Flow HIV Test Market Share Gains
•  
Potential New International Market Opportunities for Lateral Flow and DPP® Products

Research & Development
•  
New Branded Products to Replenish Pipeline
•  
New OEM Development Agreements






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. 140

Research and Development – 12
Regulatory and Clinical QA & QC – 13
Sales, General & Administration – 9
Operations- 106

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 on Revenue*

(See Graphic)






Slide 23

CEMI Selected Share Data
Ticker Symbol (OTC:QB)
CEMI.QB
Price 10/31/2011
$ .450
52-Week High
$0.580
52-Week Low
$0.210
Outstanding Shares
63.3
Market Capitalization
$0.00
Fully Diluted Shares
69.6
Management Holding
12.4
Average Daily Volume (3 months)
50,000

Options and Warrants
Amt.
Avg. Ex. Price
Options
(4.64MM held by mgmt. & board)
6.09
$0.213
Warrants (MM)-Exp. By 02/15/12
                                     .07
                                    $0.810
Total Options & Warrants (MM)
6.26
$0.22


(See graphics)


Slide 24

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

·  
Submitted PMA Module I in Q2 2011
·  
Submitted PMA Module II in October 2011 US
·  
Clinical trials being completed Q-4 2011 for Submission of Module III  Q1 2012
·  
Anticipated FDA OMA Approval, CLIA waiver and Product Launch in 2012


 (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
Pre- IDE Studies 2011, Q1-2012 with “Phase II” Clinical Trials Beginning Thereafter

•  
Patented All-In-One Barrel Device
•  
Increasing Market Acceptance in Professional Market (Clearview by Alere)
•  
IDE, Clinical Trials 2012-2013
•  
Anticipated Approval 2014


(See graphic)


Slide 27 
 
 
(See graphics)