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

Investment Highlights

•  
Develops, Manufactures & Markets Point-of-Care Diagnostic Tests
•  
Robust pipeline of POC diagnostics for infectious diseases based on lateral flow and proprietary DPP® platforms.
•  
2011 product revenues increased by 29%.     Three consecutive years of profitability
•  
$7 billion POC test market the fastest growing segment of $40 billion dollar in-vitro diagnostic market
•  
Key license and distribution partners in U.S. and South America driving revenue growth with multiple opportunities for additional strategic partnerships
•  
Seasoned management team with relevant industry and financial experience

 
Slide 4

Our Business Strategy

·  
ESTABLISH Chembio-DPP® Brand Serving Public Health & Related Markets
·  
CONTINUE to Increase Revenue and Profitability Growth to Drive Shareholder Value
·  
COLLABORATE to Address New Market Opportunities by Leveraging our IP, Core Development and Manufacturing Competencies


Slide 5

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

POC HIV Test Markets
‐  
Current Professional Market Estimate:
•  
$200MM Global - $60MM US
‐  
Potential US HIV OTC (Self-testing) Market Estimates:
•  
$150MM - $500MM

Other Current & Potential U.S. POCT Markets
‐  
Syphilis POCT Market
•  
Estimated $75MM
‐  
Hepatitis-C POCT Market
•  
Estimated $100MM
‐  
Veterinary POCT
•  
Current $100MM


See Graphic

Slide 6

FDA Approved Lateral Flow HIV Tests Sold Globally

•  
Essential Tool in Prevention Efforts Globally
‐  
50,000 New Cases of HIV Annually Still in U.S.
‐  
Estimated that >20% of HIV-Positive Individuals in U.S. unaware of their status
•  
Marketed Exclusively in U.S. Professional Market by Alere, Inc. (NYSE: ALR)
‐  
Chembio’s U.S. Market Sales (to Alere, Inc.) Increased by 36.5% in 2011 to $7.2MM
‐  
Sold Through Distribution Ex-U.S.
•  
Pre-IDE Studies Ongoing  for OTC “Barrel” HIV Test


See Graphics


Slide 7

U.S. Rapid HIV Test Market - Solid Growth Since 2006 with New CDC Testing Recommendations


 
Complete
(Ex-U.S. Chembio Sure Check®)
HIV 1/2
STAT-PAK®
DPP®
HIV  Screen
OraQuick® Advance
Uni-Gold®
           
Manufacturer
Chembio
Medford, NY
Chembio
Medford, NY
Chembio
Medford, NY
Orasure  Bethlehem, PA
Trinity Biotech, Dublin Ireland
FDA Approval Date
2006
2006
Clinical trials 98% Completed
2003
2003
Technology
Lateral Flow &  Unitized Barrel  Device
Lateral Flow
DPP® Technology  & Closed Sample  Vial System
Lateral Flow
Lateral Flow
Est. US Market Shr.
8%
12%
N/A
65%
15%
Sample Types
All Blood Matrices
All Blood Matrices
Oral Fluid  &
All Blood Matrices
Oral Fluid, Whole Blood, Plasma; not  serum
All Blood Matrices
True IgG Control
Yes
Yes
Yes
Yes
No
Sample Size
(in microliters)
2.5
5
5
5
40
HIV-2
Yes
Yes
 Yes
Yes
No
 
 
Slide 8

CHEMBIO PATENTED TECHNOLOGY: DUAL PATH PLATFORM (DPP®)

•  
A Patented Platform Technology with a Multitude of Potential Diagnostic Applications
•  
Improves Performance (Sensitivity and Specificity)
‐  
Features Independent Sample Path and Direct Binding
‐  
Enables Improved Multiplex Products

Foundational DPP Patent issued in U.S.; Additional patents issued or pending in U.S. & many foreign jurisdictions

See Graphics


Slide 9

Supply, License & Technology Transfer Contracts with Brazil’s Oswaldo Cruz Foundation (FIOCRUZ)

•  
Five Contracts with Aggregate $23MM of Minimum Purchases, All Products Approved in Brazil 2010-11
•  
$4.5MM Revenues in 2011; >$9MM Anticipated in 2012
•  
Possible New Products and Collaborations with FIOCRUZ  & Others in Brazil


Slide 10

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

•  
Clinical Trials Being Completed
•  
Anticipated FDA PMA Approval in 2012
•  
Market Launch 2013
•  
Improved Performance & Features Compared to Market Leader

See Graphic


Slide 11

Branded Product: DPP® Syphilis Screen & Confirm
•  
First Dual POCT for Syphilis Enables Confirmation & Treatment at POC
•  
CE Marked October 2011, International Distribution being Established
•  
US 510(K) Clinical Trials 2012
Developed in collaboration with the U.S. Centers for Disease Control


See Graphic

Slide 12

Financial Summary - FY2009-2011 Results

•  
Product Revenue Growth of 40.8% over period to $17.4MM in 2011
•  
Gross Margin Growth of 60% over period to $9.4MM in 2011
•  
Non-Recurring Items Included in Net Income
‐  
$1.5MM QTDP Grant in 2010 credited to R&D Expense
‐  
$.3MM 2010 Expense related to possible Strategic Transaction
‐  
2011 – Recognition of deferred tax asset valuation allowance of $5.1MM


See Graphic


Slide 13

Three Months & Years Ended  Dec. 2011 & 2010 Selected Financial Results

in (000's)
3 Mo. Dec. 31, 2011
3 Mo. Dec. 31, 2010
Y/E Dec. 31, 2011
Y/E Dec. 31, 2010
                 
Net Product Revenues
 $            5,906
 
 $            5,179
 
 $         17,422
 
 $         13,516
 
Non-Product Revenues
                310
 
                  488
 
             1,966
               
             3,188
 
TOTAL REVENUES
 $          6,216
 
 $           5,667
 
 $        19,388
 
 $        16,705
 
                 
GROSS MARGIN
             2,743
44%
               2,491
44%
             9,390
48%
             8,101
48%
                 
OPERATING COSTS:
               
                 
Research and development expenses
             1,181
19%
               (236)
-4%
              4,878
25%
             2,586
15%
Selling, general and administrative expense
             1,011
16%
                797
14%
              3,424
18%
             2,941
18%
 
             2,192
 
                561
 
             8,302
 
             5,527
 
                 
INCOME FROM OPERATIONS
                551
 
             1,930
 
             1,088
 
             2,574
 
                 
OTHER INCOME (EXPENSES):
                  (3)
 
                  (3)
 
                (12)
 
                (15)
 
                 
NET INCOME-Before Taxes
                547
9%
             1,927
34%
             1,076
6%
             2,559
15%
                 
Income tax (benefit) provision
           (5,133)
 
                  46
 
           (5,133)
 
                  46
 
                 
NET INCOME
             5,681
91%
             1,881
33%
             6,209
32%
             2,513
15%



Slide 14

Revenue Growth by Category: 2009 - 2011

See Graphic



Slide 15


Potential Impact of OEM & Branded Products on Revenue*

See Graphic



Slide 16

CEMI Selected Share & Balance Sheet Data

(in millions except per share and daily volume data)
Ticker Symbol (OTC-QB)
CEMI
Price 2/22/12
$0.475
52-Week High
$0.580
52-Week Low
$0.210
Outstanding Shares
63.3
Market Capitalization
$30.1
Fully Diluted Shares
69.7
Management Holding
12.5
Average Daily Volume (3 months)
35,500


($ in millions)
Dec'11
Dec. '10
Cash
 $      3,011
 $     2,136
Total Current Assets
         8,992
         7,637
Total Assets
 $    15,486
 $     9,086
     
Total Current Liabilities
         2,858
         3,076
Total Liabilities
         2,991
         3,277
     
Total Equity
       12,495
         5,809
     
Total Liabilities & Stockholders’ Equity
 $    15,486
 $      9,086


Options
Amt.
Avg. Ex. Price
4.84MM held by Mgmt. & Board
6.33MM
$0.229





Slide 17

Organization & Facility

•  
FDA & USDA- Approved Development & Manufacturing Facility

•  
 28,000 Sq. Ft. Leased Facility in Medford, NY

Total Employment: Approx. 159

Reg. & Clinical QA &QC
9
SG&A
13
Research & Development
21
Operations
116


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
Rick Bruce
VP Operations
2000



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



Slide 19

Anticipated Milestones 2012-13

Product Revenues  & Operating Results
•  
Full Year of New Products Launched in Brazil through FIOCRUZ
•  
Launch of DPP® HIV & Syphilis Tests in Global & US Markets
•  
Increased Lateral Flow HIV Test Sales in U.S. & Global Markets
Potential New Products & Marketing Collaborations
•  
Developments Related to Potential New Branded and/or OEM Products & Related Strategic Collaborations

Clinical & Regulatory Programs for Branded Products
•  
DPP® HIV Oral Fluid Test
‐  
Completion of Clinical Trials
‐  
Submit Module III for DPP®HIV PMA Approval
‐  
CLIA waiver, Product Launch
‐  
Potential OTC FDA Submission Activities
•  
Syphilis Screen & Confirm
‐  
Completion of Clinical Trials
‐  
Submit to FDA for 510(K) Clearance for Product Launch
•  
HIV OTC
‐  
Potential  OTC FDA Submission Activities for Sure Check® HIV @ DPP® HIV

 
 

 

Slide 20

Chembio Diagnostics, Inc.

RAPID tests for EARLIER treatments

Appendix                                                                                                March 2012



Slide 21
Comparative Selected Operating Results 2006-2011

(in 000s)
2011
 
2010
 
2009
 
2008
 
2007
 
2006
 
REVENUES:
                       
Net Product sales
 $           17,422
 
        13,516
 
        12,372
 
        10,356
 
          8,765
 
          6,294
 
Non-product revenues
                1,966
 
          3,189
 
          1,462
 
             694
 
             466
 
             208
 
TOTAL REVENUES
              19,388
 
 $     16,705
 
 $     13,834
 
 $     11,050
 
 $     9,231
 
 $    6,502
 
Cost of sales
                9,998
 
          8,604
 
          7,974
 
          7,198
 
          6,435
 
          4,894
 
GROSS MARGIN
                9,390
48%
          8,101
48%
          5,860
42%
          3,852
35%
          2,796
30%
          1,608
25%
OVERHEAD COSTS:
                       
Research and development expenses
                4,878
25%
          2,586
15%
          2,884
21%
          2,606
24%
          1,907
21%
          1,401
22%
Selling, general and administrative expenses
                3,424
18%
          2,941
18%
          2,659
19%
          3,317
30%
          3,765
41%
          4,787
74%
 
                8,302
 
          5,527
 
          5,543
 
          5,923
 
          5,672
 
          6,188
 
INCOME (LOSS) FROM OPERATIONS
                1,088
 
          2,574
 
             317
 
         (2,071)
 
         (2,876)
 
         (4,580)
 
OTHER INCOME (EXPENSES):
                       
Other income (expense)
                      -
 
                (4)
 
                (7)
 
               96
 
             121
 
              (57)
 
Interest income
                       6
 
                 4
 
                 9
 
               34
 
             145
 
               29
 
Interest expense
                   (19)
 
              (15)
 
              (10)
 
                (8)
 
              (17)
 
            (387)
 
 
                   (13)
 
              (15)
 
                (8)
 
             122
 
             249
 
            (415)
 
NET INCOME (LOSS) BEFORE INCOME TAXES
                1,075
 
          2,559
 
             309
 
         (1,949)
 
         (2,627)
 
         (4,995)
 
Income tax (benefit) provision
              (5,133)
 
               46
 
 
                -
 
                -
 
                -
 
NET INCOME (LOSS)
                6,208
32%
          2,513
15%
             309
2%
         (1,949)
-18%
         (2,627)
-28%
         (4,995)
-77%
Pref. Divid. '06/07, beneficial conversion feature in 2006 and effect of conversion in 2007
                      -
 
                -
 
                -
 
                -
 
          5,645
 
          3,210
 
NET INCOME (LOSS) ATTRIBUTABLE TO COMMON STOCKHOLDERS
 $             6,208
 
 $       2,513
 
 $          309
 
 $      (1,949)
-18%
 $      (8,272)
-90%
 $      (8,205)
-126%
Basic income (loss) per share
 $               0.10
 
 $         0.04
 
 $         0.00
 
 $        (0.03)
 
 $        (0.57)
 
 $        (0.80)
 
Diluted income (loss) per share
 $               0.09
 
 $         0.04
 
 $         0.00
 
 $        (0.03)
 
 $        (0.57)
 
 $        (0.80)
 
Weighted average number of shares outstanding, basic
              62,998
 
        62,103
 
        61,946
 
        61,267
 
        14,608
 
        10,293
 
Weighted average number of shares outstanding, diluted
              68,450
 
        70,921
 
        75,042
 
        61,267
 
        14,608
 
        10,293