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.
•  
Record Revenues and Income in 2009-2011 and 2012YTD
•  
Participating in $10 billion POC test market
•  
Partnered with leading license and distribution partners in U.S. and South America
•  
Multiple opportunities for additional products & strategic partnerships
•  
Seasoned management team with relevant industry and financial experience


 
Slide 4

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 5

Three Months Ended March 31, 2011 & 2012 Selected Financial Results

See Graphic

 
 
 

 
Slide 6

Our Business Strategy

·  
ESTABLISH Chembio-DPP® Brand Serving Public Health & Related POCT Market Opportunities
·  
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 7

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

‐  
Rapid HIV Test Markets
•  
$200MM Global
•  
Chembio  Products  in U.S. & Global Markets
•  
Potential HIV OTC (Self-testing) Market  Estimated at >$250MM
‐  
Other Current  & Potential
 
U.S. or Global POCT Markets
•  
Syphilis POCT Market
–  
Estimated $75MM
–  
DPP® Syphilis Screen & Confirm Tests in EU and Brazil; U.S. Clinical Studies
•  
HIV/Syphilis Multiplex
•  
Hepatitis-C POCT Market
–  
Estimated at >$250MM
–  
R&D
•  
Veterinary POCT
–  
Current $100MM
–  
R&D
See Graphic



Slide 8

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) increased by 36.5% in 2011 to $7.2MM
‐  
Estimated 20% U.S. market share
‐  
Sold through distribution ex-U.S.
Pre-IDE Studies Ongoing for OTC “Barrel” HIV Test

See Graphics


Slide 9

Product Portfolio At a Glance Chembio Patented Dual Path Platform Technology

See Chart


Slide 10

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) 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 11

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

MULTIPLEX  DPP® HIV Confirmatory Test Launched in Brazil

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


See Graphics


Slide 12

OEM Collaboration with Brazil’s Oswaldo Cruz Foundation (FIOCRUZ) for DPP® - 5 Products Approved 2010-2011

•  
Five Contracts with Aggregate $23MM of Minimum Purchases, All Products Approved in Brazil 2010-11
•  
$4.3MM Revenues in 2011 >$9MM Anticipated in 2012
•  
Possible New Products and Collaborations with FIOCRUZ  & Others in Brazil


See Graphic

Slide 13

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 & Unique Features

See Graphic


Slide 14

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




 
Complete
(U.S.)  Sure Check®,(Intl)
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 15

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 16

Three Months Ended  March 31, 2012 & 2011, Years Ended Dec. 2011 & 2010
Selected Financial Results

         
in (000's)
3 Mo. Mar. 31, 2012 
3 Mo. Mar. 31, 2011 
Y/E Dec. 31, 2011
Y/E Dec. 31, 2010
                 
Net Product Revenues
 $            6,363
  
 $            3,015
  
 $         17,422
  
 $         13,516
  
Non-Product Revenues
290
  
621
  
1,966
  
3,188
  
TOTAL REVENUES
 $          6,653
  
 $          3,636
  
 $        19,388
  
 $        16,705
  
                 
GROSS MARGIN
3,333
50%
             1,926
53%
             9,390
48%
             8,101
48%
                 
OPERATING COSTS:
                
                 
Research and development expenses
1,379
12%
1,290
35%
4,878
25%
2,586
15%
Selling, general and administrative expense
1,234
19%
775
21%
3,424
18%
2,941
18%
 
             2,613
  
                2,065
  
             8,302
  
             5,527
  
                 
INCOME FROM OPERATIONS
                720
  
 (139)
  
             1,088
  
             2,574
  
                 
OTHER INCOME (EXPENSES):
                  (1)
  
                  (3)
  
                (12)
  
                (15)
  
                 
NET INCOME-Before Taxes
                719
11%
(142)
-4%
             1,076
6%
             2,559
15%
                 
Income tax (benefit) provision
285
  
-
  
           (5,133)
  
                  46
  
                 
NET INCOME
             433
7%
  (142)
-4%
             6,209
32%
             2,513
15%
 
 
Slide 17

CEMI Selected Share & Balance Sheet Data

(in millions except per share and daily volume data)
Ticker Symbol (OTC-QB)
CEMI
Price 2/22/12
$0.490
52-Week High
$0.570
52-Week Low
$0.210
Outstanding Shares
63.9
Market Capitalization
$31.3
Fully Diluted Shares
69.7
Management Holding
12.5
Average Daily Volume (3 months)
32,500
 
 

($ in millions)
Mar’12
Dec'11
Dec. '10
Cash
$   2,954
 $     3,011
 $    2,136
Total Current Assets
10,033
         8,992
        7,637
Total Assets
$16,360
 $   15,486
 $    9,086
       
Total Current Liabilities
3,133
         2,858
        3,076
Total Liabilities
3,254
         2,991
        3,277
       
Total Equity
13,106
      12,495
        5,809
       
Total Liabilities & Stockholders’ Equity
$16,360
 $   15,486
 $    9,086


Options
Amt.
Avg. Ex. Price
  
4.31MM held by Mgmt. & Board
5.82MM
$0.229





Slide 18


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 19

Organization & Facility

•  
FDA & USDA- Approved Development & Manufacturing Facility

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

Total Employment: Approx. 170

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


 



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



Slide 21

Investment Highlights

•  
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 and multiple opportunities for additional strategic partnerships
•  
Seasoned management team with relevant industry and financial experience








Slide 22

Chembio Diagnostics, Inc.

RAPID tests for EARLIER treatments

Thank You

Additional Slides



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
  



Slide 24

Revenue Growth by Category: 2009-2011

See Charts

Slide 25

Potential Impact of OEM & Branded Products on Revenue*

See Graphic


May 2012