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



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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 develop, manufacture, market and finance new products 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. Other 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

Investment Summary

•  
Develops, Manufactures & Markets Point-of-Care Diagnostic Tests (POCTs)  Using Company's Patented DPP® Platform Technology
•  
Products Sold Globally
•  
>25% CAGR Product Sales Growth FY2009-2012
•  
Partnered with Leading License & Distribution Partners in U.S. & South America
•  
Recent FDA Approval of Oral Fluid HIV Test
•  
Strong Pipeline of POCTs
•  
Experienced Management Team


 
Slide 4

Chembio Diagnostics – Revenues & Markets

2012 - $25.6MM Revenue Business, $1.45MM Operating Income
·  
~50% Lateral Flow HIV Tests
o  
Participating in $250MM Ex-US Market
o  
Est. 25% Share of US Market through Alere
·  
~40% DPP®  Patented POCT Platform
o  
All New Products and Under Development Based on DPP®
o  
Enables Improved Performance, Multiplexing
o  
Oral Fluid HIV Test FDA Approved 12/2012
o  
Five Products Approved and Successfully Launched in Brazil- 2011-2012
o  
~10% Other Products, Grants

Slide 5

Anticipated Developments - 2013-2015

·  
Oral Fluid HIV Test CLIA Waiver & Launch
·  
Expanding International Revenues for Lateral Flow and DPP® Products
·  
FDA Submission & Approval of Two POCT Multiplex Syphilis Tests Based on DPP® Technology – Estimated $50MM US Market
·  
Development & FDA Approval of Multiplex Antigen/Antibody DPP® Tests for HIV and HCV – Estimated $100MM US Market
·  
FDA Approval of At-Home HIV Test – Estimated $100MM US Market

Slide 6

Chembio POCT Market Opportunities

•  
HIV Rapid POCTS
•  
Established $250MM Global Market
•  
~50,000 New Infections in US – 2012; 2.5 MM Worldwide
•  
Routine Testing USPSTF Recommendation
•  
CEMI Only Company with 3 FDA-Approved Tests
•  
CEMI Tests Designated in Selected International Protocols

•  
Syphilis Rapid POCTS– New Market Opportunity
•  
Up to 70% HIV-Syphilis Co-Infection  in MSM
•  
All HIV+ Need be Tested for Syphilis, & Vice Versa
•  
CEMI Has Two Unique POCTs – Anticipate 2014 Launch

•  
Hepatitis-C Rapid POCT– New Market Opportunity
•  
70MM  U.S. Baby Boomer Screening Opportunity; New Therapeutics
•  
Product in Development

Slide 7

DPP® - Chembio’s Patented POCT Platform Technology
·  
Enables Multiplexing for Multiple Markers
·  
Increase Sensitivity As Compared with Lateral Flow Technology
·  
Validated with Numerous Partners, Regulatory Agencies
·  
Patents Issued in US and Multiple Countries , Continuing Prosecution & Expansion of IP

See graphics


Slide 8

POCT’s – A Growing Global Market
Converting Lab Tests to POC and Creating New Markets

Est. $10B Global POCT Market; >$45B Total In-Vitro DX Market

See Graphics


Slide 9

Two FDA-Approved Lateral Flow Rapid HIV Tests Sold Globally

•  
Utilize In-Licensed Lateral Flow Technology
•  
Large International Screening Programs (PEPFAR)
•  
Significant Potential New International Opportunities Pending
•  
In US Sold Exclusively through Alere under the Clearview label
•  
2012 Sales to Alere $7.8MM, Agreement through 10/2016

See Graphic

Slide 10

DPP HIV®1/2 Test for Use with Oral Fluid or Blood Samples


•  
First FDA-Approved Product on DPP® (Dec. 2012)
•  
CBER PMA-Approved, CLIA Waiver Pending
•  
Improved Sensitivity v. Market Leader*
•  
Earlier Detection of Seroconverting Patients
•  
Proprietary  SampleTainer™ Sample Collection System

*Study Sponsored by CDC Global AIDS Program

See Graphics
 
 
 
Slide 11

Collaboration with FIOCRUZ in Brazil

•  
First Commercial Success with DPP®
•  
Contracts with Supplier to Brazilian Federal Ministry of Health
•  
$23MM of Potential Purchases (~$16MM Revenues 2011-2012 to date) for Five DPP® Products  - May be exceeded
•  
Expect Tech Transfer & Conversion to License 2013-14
•  
Potential New Products

See Graphics
 

 
Slide 12

U.S. HIV Self-Testing  “OTC” Opportunity

•  
Chembio Uniquely Positioned
•  
Assessing Market Size and Best Approach
•  
Filing IDE Early 2013 for Sure Check HIV
•  
Pre-IDE Self-Testing Studies Show 100% Accuracy (n=300)

 
Slide 13

DPP® Syphilis Screen & Confirm & HIV-Syphilis Multiplex Tests

•  
Large Global Market Opportunity for Pre-Natal and MSM Screening
•  
Anticipated FDA Submissions in 2013, 2014 Clearances
•  
Additional Products for Public Health Channel
•  
Leveraging DPP®  Multiplexing Features

See Graphics


Slide 14

Pipeline: Rapid Hepatitis C Point-of-Care Diagnostic

•  
Data Published in Journal of Clinical Virology  showed good performance of Chembio's 1st Generation Prototype Assay
•  
Completed Feasibility to Establish Performance Comparable to Only POCT HCV Test – 2013 R&D to incorporate additional value-added features
•  
Recent CDC recommendations for testing on everyone born between 1945-1964
•  
Anticipated Timeline
‐  
Development & Clinical Trials – 2013-2014
‐  
US Market Launch Anticipated - 2015

See Graphic


Slide 15

Selected Financial Data FY2008 –2012
Reporting Record Revenues Again for FY2012
(in 000’s)

2012
·  
Total Revenue $25,611
·  
Product Revenue $24,327
·  
Gross Profit $10,790
·  
R&D Expense Incl. Clin. Trials* $4,486
·  
Pre-Tax Income $1,450

* Non-recurring 2010 $1.5MM R&D Credit from the Affordable Care Act – excluded from 2010 R&D Exp. & 2010 Pre-Tax Income

See Graphic



Slide 16

Strong Revenue & Operating Income Growth in FY 2012

In (000’s)
Dec. 31, 2012
 
Dec. 31, 2011
 
Net Product Revenues
 
$24,327
 
$17,422
 
Non-Product Revenues
$  1,283
 
$ 1,966
 
TOTAL REVENUES
$25,610
 
$ 19,388
 
GROSS MARGIN
$ 10,790
42%
$9,390
48%
OPERATING COSTS:
       
Research and Development exp
$ 4,486
18%
$4,878
25%
Selling, G&Administrative exp
$ 4,852
19%
$3,424
18%
 
$ 9,338
 
$8,302
 
INCOME FROM OPERATIONS
$ 1,452
 
$1,088
 
OTHER INCOME (EXPENSES):
$      (2)
 
$      (12)
 
NET INCOME-Before Taxes
$ 1,450
6%
$1,076
6%
Income tax (benefit) provision
$  509
 
$ (5,133)
 
NET INCOME
$  941
4%
$ 6,209
32%



 
Slide 17

CEMI Selected Share & Balance Sheet Data
(in millions except per share and daily volume data)

Ticker Symbol (NASDAQ)
CEMI
Price 2/28/13
$5.48
52-Week High
$5.80
52-Week Low
$3.52
Outstanding Shares
 8.09
Market Capitalization
$44.31
Fully Diluted Shares
 8.82
Management Holding
 1.62
Average Daily Volume (3 months)
39,000
Average Daily Volume (1 month)
22,000


Options
Amt.
Avg. Ex. Price
514K held by Mgmt. & Board
717K
$2.40


($ in 000s)
12/31/12
12/31/11
12/31/10
Cash
$  2,952
 $     3,011
 $    2,136
Total Current Assets
11,009
         8,992
        7,637
Total Assets
$17,335
 $   15,486
 $    9,086
Total Current Liabilities
3,378
         2,858
        3,076
Total Liabilities
3,460
         2,991
        3,277
Total Equity
13,875
      12,495
        5,809
Total Liabilities & Stockholders’ Equity
$17,335
 $   15,486
 $    9,086

See Graphics


 
 
 

 

 
Slide 18

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
Sharon Klugewicz
VP QA/QC & Technical Operations
2012
Rick Bruce
VP Operations
2000
Michael Steele
VP Sales Marketing & Bus. Dev.
2012


Independent Directors                                                                                                                                           Joined Board:
Gary Meller, MD, MBA
2005
Katherine Davis, MBA
2007
Barbara DeBuono, MD, MPH
2011
Peter Kissinger, Ph.D
2011


Slide 19

Organization & Facility

•  
FDA & USDA- Approved Development & Manufacturing Facility

•  
 All Company Operations in 30,600 Sq. Ft. Leased Facility in Medford, NY


Total Employment: Approx. 170

Reg. & Clinical QA &QC
15
SG&A
11
Research & Development
29
Operations
116

See Graphics

 
 
Slide 20

Investment Summary

•  
Develops, Manufactures & Markets Point-of-Care Diagnostic Tests (POCTs)  Using Company's Patented DPP® Platform Technology
•  
Products Sold Globally
•  
>25% CAGR Product Sales Growth FY2009-2012
•  
Partnered with Leading License & Distribution Partners in U.S. & South America
•  
Recent FDA Approval of Oral Fluid HIV Test
•  
Strong Pipeline of POCTs
•  
Experienced Management Team

See Graphic



Chembio Diagnostics, Inc.
RAPID tests for EARLIER treatments