EX-99.2 3 investorpresentation.htm EXHIBIT 99.2 INVESTOR PRESENTATION


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)  Used Globally

•
$25.6MM 2012 Revenues, Profitable
‐
Anticipate Record Revenues in Second Half 2013

•
Patented DPP® - A Platform POCT Technology
‐
Oral Fluid HIV Test-FDA –Approved - CLIA waiver pending

•
Strong Product Pipeline of Multiplex DPP Products
‐
HIV-Syphilis Test for International and US Markets
‐
HCV & HIV Ag-Ab Test
‐
New Technologies for Multiplex Products
‐
New Collaboration in Brazil with LabTest
 
Slide 4


Chembio's  Pipeline - $700MM Total Addressable Market

Chembio Pipeline POCT
Total Market Opportunity
  
Targeted Launch
  
US HIV
$ 75 MM
    
Q4-2013
  
US Syphilis-HIV
$ 75 MM
    
2H- 2014
  
US HCV*
$100 MM
    
2015
  
US OTC-HIV*
$ 50 MM
    
2015-2016
  
International
$400 MM
    
2013-2016
  
Total
$700 MM
    
2013-2016
  

* Subject to market assessments/developments, and/or attainment of R&D and regulatory milestones

See graphic


Slide 5


Chembio's Current & Near Term POCT Market Opportunities

HIV Rapid POCTS  - Established, Growing Market
•
~50,000 New Infections in US - 2012 ; 2.5 MM Worldwide
•
U.S. - Routine Testing USPSTF Recommendation
‐
ACA Expanding Coverage by 25MM+
•
International - Designation in PEPFAR & Other Donor-Funded Countries' Testing Protocols
•
HIV-Syphilis POCTS – New Market Opportunity
•
Up to 70% HIV-Syphilis Co-Infection in MSM
•
Higher Prevalence of  Syphilis (1.9MM) than HIV (1.5MM) in Pregnant Women

HCV POCT – Emerging Market Opportunity
•
4MM in US Infected ` 75% Unaware
•
Recent Revised CDC & USPSTF Recommendations for All Baby Boomers
•
New Therapeutics

See graphic



Slide 6
 
POCTs - A Growing $10B Global Market -Examples of Product Opportunities for the Long Term
•
Labtest Brazil*
•
Febrile Illnesses Contract with U.S. Gov. Agency*
•
Influenza Immunity Contract with CDC Contractor*
•
Hepatitis-C and HIV Fourth Generation Tests
‐
Associated CDC Recommendations
*announced May 2013

CURRENT CAPABILITIES
·
Lateral Flow Technology
·
Single parameter tests
·
DPP® Technology Enabling
·
Improved Sensitivity, Multiplexing

R&D
·
Signal
·
Enhancement  Features

POTENTIAL NEW CAPABILITIE BEING ASSESSED
·
Molecular
·
Amplification Technologies


Slide 7

Lateral Flow Rapid HIV Tests Marketed World-Wide

•
Total $13.5MM 2012 Revenues
•
In U.S. Sold Exclusively through Alere (Clearview®)
‐
$7.8MM 2012; $2.3MM Q2'13 vs. $2.1MM Q2'12 ; $4.9MM YTD'13 vs. $4.6MM YTD'12
‐
Opportunity to Sell Direct Under Chembio  brand  based on new Alere "competitive" product
•
International Sales - Chembio Branded Through Multiple Channels:
‐
E.g., PEPFAR, Global Fund UNICEF, etc.
‐
$5.7MM 2012;$2.3MM Q1'13 92% increase from Q1 '12
‐
Record 2H Anticipated Based on Record $5.3MM Order



See graphics



Slide 8

U.S. HIV Self-Testing  "OTC" Opportunity
·
Chembio Uniquely Positioned
·
Still Assessing Market Size –
o
OSUR Spending $7MM/QTR on HIV OTC Market Launch

See Graphics


Slide 9
 
Ongoing Collaboration with Brazilian MOH Affiliate  Complemented by New Agreement with Labtest
‐
Five DPP® Products  with Brazilian MOH Supplier
‐
$10.1MM 2012 Revenues
‐
~$6MM Forecast 2013, Potential of $9MM in 2014.
‐
Potential New Product
•
New Collaboration with Labtest Brazil*
‐
Leading Brazilian IVD Company
‐
Addressing Private & Public Markets in Brazil
‐
Potential Additional Markets, Contract Manufacturing
‐
Assembly & Distribution - DPP® Co-branded
‐
2013 Plan = Initial Products Registrations
*announced May 2013

See graphics


Slide 10
DPP® Patented Point of Care Technology

•
Proprietary Platform Technology that Uniquely Enables Multiplexing for Higher Value Tests
•
Increases Sensitivity as Compared with Lateral Flow Technology
•
Validated with Numerous Partners, Regulatory Agencies

See graphics


Slide 11

Chembio DPP® HIV 1/2 Assay FDA-Approved Dec. '12,  CLIA Waiver expected Q4 2012
·
Superior blood matrix performance over top 4 market share products in early detection study
·
Superior Oral Fluid sensitivity v. Market Leader in head-to-head study
·
User friendly, safe and efficient SampleTainer™ Sample Collection System
·
Separate and reagent free oral fluid collection device
See graphics
 
Slide 12

DPP® HIV 1/2 Assay v. Leading Competitor,  Superior U.S. Label Claims

 
DPP HIV 1/2
Oraquick ADVANCE
Performance
     Sensitivity*
     Specificity*
99.9% WB/P/S; 99.8% FS; 98.9% OF 100% FS; 99.9% OF/WB/P/S
(Note: No S or WB claims)
99.6% FS/P; 99.3% OF
99.9% P, 100% FS, 99.8% OF
External Controls
12 month open vial
30 day open vial
Patient Age
2+ years of age
12+ years of age
Result Read Time
25-40 min OF
10-25 min FS/P/WB/S
20-40 min OF/FS/P


DPP® HIV 1/2 Assay superior performance in recent studies (CDC-Mozambique) in "naïve" (undiagnosed) populations for which the test will be utilized, and more published articles on OraQuick market performance

*Note:  Orasure conducted its U.S. trials 1999-2001 before widespread deployment of Highly Active Anti-Retroviral Therapy (HAART).

Note: Oral Fluid (OF), Venous Whole Blood (WB), WB Finger Stick (FS), Plasma (P), Serum (S)


Slide 13
 
DPP® Syphilis Test
•
Large Global Market Opportunities for Pre-Natal and MSM Screening
‐
HIV-Syphilis Comb. Leverages Global PMTCT Funding
‐
USAID and WHO Evaluations in Process
‐
INDRE (Mexico) Data @100% Sensitivity & Specificity
•
Anticipated FDA Approval(PMA) in Q4 2014 – Clia waiver Q1 2015
‐
Recent Meeting with FDA Extending Review Period Due to Change to PMA (v. 510K)
‐
Significant Potential International Sales 2013 -14


Slide 14

Selected Financial Data FY2008 –2012
See Graphic

2012
·
Total Revenue $25,611
·
Product Revenue $24,327
·
Gross Profit $10,790
·
R&D Expense* $4,486
·
Pre-Tax Income $1,451

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


Slide 15

FY2010-2012 Selected Financial Results


 
  
Year Ended
    
   
Year Ended
    
   
Year Ended
    
 
In (000's)
  
Dec 31, 2012
    
   
Dec. 31, 2011
    
   
Dec. 31, 2010
    
 
Net Product Revenues
 
  
$
24,327
    
   
$
17,422
    
   
$
13,516
    
 
Non-Product Revenues
  
$
1,283
    
   
$
1,966
    
   
$
3,188
    
 
TOTAL REVENUES
  
$
25,610
    
   
$
19,388
    
   
$
16,704
    
 
GROSS MARGIN
  
$
10,790
    
42
%
  
$
9,390
    
48
%
  
$
8,101
    
48
%
OPERATING COSTS:
                                          
Research and Development exp
  
$
4,486
    
18
%
  
$
4,878
    
25
%
  
$
2,586
    
15
%
Selling, General &Administrative exp
  
$
4,852
    
19
%
  
$
3,424
    
18
%
  
$
2,941
    
18
%
 
  
$
9,338
          
$
8,302
          
$
5,527
        
INCOME FROM OPERATIONS
  
$
1,452
          
$
1,088
          
$
2,574
        
OTHER INCOME (EXPENSES):
  
$
(2
)
        
$
(12
)
          
(15
)
      
NET INCOME-Before Taxes
  
$
1,450
    
6
%
  
$
1,076
    
6
%
  
$
2,559
    
15
%
Income tax (benefit) provision
  
$
509
          
$
(5,133
)
        
$
46
        
NET INCOME
  
$
941
    
4
%
  
$
6,209
    
32
%
  
$
2,513
    
15
%

2012 U.S. Lateral Flow HIV Sales                                                                                    $ 7.8 MM
       2012 Ex-U.S. Lateral Flow HIV Sales  $ 5.7 MM
       2012 Brazil DPP Sales                                                                      $10.1 MM


Slide 16
 
Second Quarter and First Half, 2012-2013 Selected Financial Results

 
  
3 Mos Ended
    
   
3 Mos Ended
    
   
6 mos June 30, 2013
    
   
6 mos June 30,2012
    
 
In (000's)
  
June 30, 2013
    
   
June 30, 2012
    
   
2012
    
   
2011
    
 
Net Product Revenues
 
  
$
5,062
    
   
$
5,811
    
   
$
11,375
    
   
$
12,174
    
 
Non-Product Revenues
  
$
332
    
   
$
273
    
   
$
697
    
   
$
563
    
 
TOTAL REVENUES
  
$
5,394
    
   
$
6,084
    
   
$
12,072
    
   
$
12,737
    
 
GROSS MARGIN
  
$
2,281
      
42
%
  
$
2,571
      
42
%
  
$
4,975
      
41
%
  
$
5,903
      
46
%
OPERATING COSTS:
                                                                
Research and Development exp
  
$
1,501
      
28
%
  
$
979
      
16
%
  
$
2,546
      
21
%
  
$
2,358
      
19
%
Selling, G&Administrative exp
  
$
1,160
      
22
%
  
$
1,079
      
18
%
  
$
2,322
      
19
%
  
$
2,313
      
18
%
 
  
$
2,661
            
$
2,058
            
$
4,868
            
$
4,671
          
INCOME FROM OPERATIONS
  
$
(380
)
          
$
513
            
$
107
            
$
1,232
          
OTHER INCOME (EXPENSES):
  
$
9
            
$
(1
)
          
$
9
            
$
(1
)
        
NET INCOME-Before Taxes
  
$
(371
)
    
-7
%
  
$
512
      
8
%
  
$
116
      
1
%
  
$
1,231
      
10
%
Income tax (benefit) provision
  
$
(130
)
          
$
203
            
$
40
            
$
489
          
NET INCOME
  
$
(241
)
    
-4
%
  
$
309
      
5
%
  
$
76
      
1
%
  
$
742
      
6
%


Slide 17

CEMI Selected Share & Balance Sheet Data
$6MM Common Stock Public Offering Closed on April 3, 2013
 1.2MM Shares @ $5.00 per share, $5.450MM Net Proceeds


(in millions except per share and daily volume data)
Ticker Symbol (NASDAQ)
  
CEMI
  
Price 07/31/13
  
$
4.83
  
52-Week High
  
$
5.80
  
52-Week Low
  
$
3.61
  
Outstanding Shares
    
9.32
  
Market Capitalization
  
$
45.04
  
Fully Diluted Shares
    
9.99
  
Management Holding
    
1.55
  
Avg.Daily Volume (3 mos to 7/31/13)
    
19,400
  
Average Daily Volume (July 2013)
    
14,300
  


Options
  
Total
    
Avg. Ex. Price
  
533K held by Mgmt. & Board
    
669
K
  
$
2.70
  


($ in 000s)
  
June'13
Unaudited
    
Dec '12
  
Cash
  
$
8,645
    
$
2,952
  
Total Current Assets
    
17,118
      
4,821
  
Total Assets
  
$
23,542
    
$
17,335
  
Total Current Liabilities
    
3,929
      
3,378
  
Total Liabilities
    
3,929
      
3,460
  
Stockholders' Equity
    
19,613
      
13,875
  
Total Liabilities & Stockholders' Equity
  
$
23,542
    
$
17,335
  

Slide 18

Leadership


Executive                                               Experience            Joined Company:
Lawrence Siebert,J.D.
Chairman & CEO
1981-1991, Partner,  Stanwich Partners, Inc.; 1992-2002 Siebert Associates LLC, Manager; Siebert Capital Corp. , President
 
2002
Richard Larkin, CPA
Chief Financial Officer
2000-2003  CFO of Visual Technology Group; 1987-2000 CFO of Protex International Corp.
 
2003
Sharon Klugewicz, M.S.
Chief Operating Officer
20+ Years at Pall Corporation, most recently as Sen. VP - Scientific & Laboratory Services
 
2012
Javan Esfandiari, M.S.
SVP Research & Development
1993-1997, R&D Director On-Site Biotech;
1997-2000, Co-Founder of Sinovus Biotech AB (Sweden), which was acquired by Chembio in 2000
 
2000



Slide 19

Organization & Facility

•
FDA & USDA- Approved Development & Manufacturing Facility
•
All Company Operations in 30,600 Sq. Ft. Leased Facility in Medford, NY
•
Pursuing Increased Efficiencies, Automation, Capacity


Total Employment: Approximately 200

Regulatory
 4
QA &QC
17
SG&A
12
Research & Development
27
Operations
142

See Graphics


Slide 20

Anticipated Developments - 2013-2014
•
Record Second Half Revenues
•
Oral Fluid HIV Test CLIA Waiver & Launch
•
Expanding International Revenues for Lateral Flow and DPP® Products
•
2014 FDA Submission & Approval of DPP HIV-Syphilis Test
•
HIV Fourth Generation & HCV Product Development Milestones
•
New Distribution, Contract Development & OEM Deals
•
Acquire/License New Technologies, Product Lines



Slide 21

Investment Summary

•
Develops, Manufactures & Markets Point-of-Care Diagnostic Tests (POCTs)  Used Globally

•
$25.6MM 2012 Revenues, Profitable
‐
Anticipate Record Revenues in Second Half 2013

•
Patented DPP® - A Platform POCT Technology
‐
Oral Fluid HIV Test-FDA –Approved - CLIA waiver pending

•
Strong Product Pipeline of Multiplex DPP Products
‐
HIV-Syphilis Test for International and US Markets
‐
HCV & HIV Ag-Ab Test
‐
New Technologies for Multiplex Products
‐
New Collaboration in Brazil with LabTest