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 to obtain regulatory approval in a timely manner, as well as 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 (POC) Diagnostic Tests
•  
In-licensed Lateral Flow technologies & Chembio’s Patented Dual Path Platform (DPP®)
•  
Branded, Private Label, and Licensing  Strategies  Anticipated to Result in Continued Organic Growth
•  
Profitable 2009-2010 and through 9/30/2011
•  
38% Product Revenue Growth through 9/30/2011 v. 9/30/2010
•  
Continued Strong Revenue Growth Anticipated in 2012, primarily from new products approved in Brazil
•  
Fully Integrated Facility in Medford, NY
•  
FDA PMA (CBER) & USDA Approved; ISO 13.485 Certified
•  
~28,000 Square Feet; 140 Employees



Slide 4

POCTs - A Growing Global Market

•  
$7B Global Point-of-Care Test (POCT) Market within $40B In-Vitro Diagnostics Market
•  
POCTs for Sexually Transmitted Diseases (STDs) & Blood Pathogens
‐  
Public/Global Health Programs
‐  
OTC HIV
•  
Other POCT Markets
‐  
Veterinary (Vector-borne, Companion, Equine, Production, Specialty)
‐  
Screening Programs



Slide 5

DUAL PATH PLATFORM (DPP®) – Improved Accuracy and Multiplexing vs. Lateral Flow Technologies
•  
Patented Platform Technology with a Multitude of Potential Diagnostic Applications
‐  
Foundational DPP Patent issued in U.S.; Additional patents issued or pending in U.S. & many foreign jurisdictions
•  
Independent Sample Path and Direct Binding
‐  
Improves Performance (Sensitivity and Specificity)
‐  
Enables Improved Multiplex Products

See Graphics


Slide 6

Our Branded Products Will Support and be Complemented By our OEM and Licensed Products

Current OEM/Licensees:  Fiocruz (Brazil), BIORAD, Alere
Potential Future OEM/License Areas: Women’s Health, Other Infectious Diseases, Veterinary : Small and Large Animal

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






Slide 7
 
Chembio’s FDA Approved Rapid HIV Tests
Marketed By Alere in U.S. and Chembio Distributors ex-U.S. for Professional Use

•  
Estimated 20% or more of the 1.1MM HIV+ individuals in U.S. are not aware of their status
•  
Products sold in US professional market by Alere Inc. (NYSE:ALR) as Clearview® brand
‐  
10-Year exclusive agreement through Sept. 2016 Based on ASP sharing
‐  
9 Month YTD Sales $5.39 Million, a 52% increase v. comparable 2010 period
•  
Ex-US under Chembio Brands (STAT-PAK® & SURE CHECK®)
•  
Chembio Pursuing OTC Approval for Sure Check







Slide 8
 
FDA Approved Rapid HIV Tests and Chembio’s DPP ®  HIV Test that is Pending Regulatory Approval
 

 
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 9

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
Clinical Trials 90%+ Complete; PMA Module I submitted and responded. PMA Module II submitted October.
Respond to Module II &
Complete Clinical Trials.
Submit Module III. FDA Approval, CLIA waiver, US Market Launch 1H 2013
$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 & US Market Launch  1H 2013
NA/$70MM
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
Complete Pre-IDE Requirements and Begin Phase II Clinical Trials
NA/$150MM
Assumes 5MM unit market @ $30/OTC unit


Slide 10

Pipeline: OEM Contracts with FIOCRUZ Brazil
Anticipate Minimum of $9MM in full year 2012 Revenues vs. $2.6MM through 9/30/2011 YTD

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
DPP® Canine Leishmaniasis
Submitted
Approved Q1’11
Commercial Sales
Commercial Sales
DPP® Leptospirosis
  
Submitted  Q2’ 2011
Commercial Sales
Approved Q3’11




Slide 11

Financial Summary - FY2008-2010 Results
•  
Record Revenues and Earnings
•  
Improving Gross Margins
•  
Operating Cash Flow Strengthened Balance Sheet
•  
$1.5MM QTDP Grant in 2010 credited to R&D Expense
•  
$.3MM 2010 Expense related to possible Strategic Transaction

See Graphic


Slide 12

2010 Full Year and Nine 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 and development expenses
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%



Slide 13

Three Months September 2010 & 2011 Selected Financial Results

 
3 MOS
Sept 30, 2011
  
3 MOS
Sept 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 administrative 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%




Slide 14

Revenue Growth by Category: 2009 vs. 2010

See Graphics



Slide 15

Revenue Growth by Category: YTD Q3-2011 vs. YTD Q3-2010

See Graphics


Slide 16

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
         8,480
         7,637
         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 & Stockholders Equity
 $    10,099
 $      9,086
 $      6,315


Slide 17

Anticipated Milestones 2012-13

Clinical & Regulatory Programs for Branded Products
•  
DPP® HIV Oral Fluid Test
‐  
Completion of Clinical Trials
‐  
Submit Module III for DPP®HIV PMA
‐  
Receive FDA PMA Approval and CLIA waiver
•  
Syphilis Screen & Confirm
‐  
Completion of Clinical Trials
‐  
Submit to FDA for 510(K) Clearance
‐  
Receive Clearance
•  
Sure Check® HIV OTC Pre-IDE
‐  
Commence & Complete Phase II Clinical Trials
Product Revenues  & Operating Results
•  
Full Year of New Products Launched in Brazil through FIOCRUZ
•  
Launch of DPP® HIV & Syphilis Tests in Global & US Markets
•  
Continued US Lateral Flow HIV Test Market Share Gains
•  
Potential New International Market Opportunities for Unique DPP® Products
Potential New Products & Marketing Agreements
•  
Developments Related to Potential New Branded and/or OEM Products & Related Strategic Collaborations



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
Gary Meller, MD, MBA
2005
Kathy Davis, MBA
2007
Barbara DeBuono, MD, MPH
2011
Peter Kissinger, Ph.D
2011
 
Slide 19

Organization & Facility

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 28,000 S/F Leased Facility in Medford, NY


Slide 20

Potential Impact of OEM & Branded Products on Revenue*

See Graphic


Slide 21

CEMI Selected Share Data

Ticker Symbol (OTC:QB)
CEMI
Price 12/30/11
$0.42
52 Week High
$0.580
52 Week Low
$0.210
Outstanding Shares (MM)
      63.3
Market Capitalization (MM)
$26.6
Fully Diluted (FD) Shares (MM)
      69.6
Management Holding (MM)-FD
      12.3
Average Daily Volume (3 Mos)
 31,000


Options and Warrants
Amt.
Avg. Ex. Price
Options
(4.64MM held by mgmt. & board)
6.18
$0.213
Warrants
(Expire by 2/15/12)
0.07
$0.810
Total Options & Warrants
6.25
$0.220

CEMI price performance

See Graphic



Slide 22

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

•  
Submitted PMA Module I in Q2 2011
•  
Submitted PMA Module II October 2011 US
•  
Clinical Trials Being Completed for Submissions of Module III in Q1 2012
•  
Anticipated FDA PMA Approval, CLIA waiver in 2012
•  
Market Launch in Q4 or early 2013

(See Graphic)

Slide 23
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
•  
CE Marked October 2011, International Distribution being Established
•  
US 510(K) Clinical Trials 2012
•  
Anticipate FDA Clearance 2013

DPP® Syphilis Screen & Confirm
·  
Developed in collaboration with the U.S. Centers for Disease Control
See Graphic


Slide 24

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 Complete by Alere)
•  
IDE, Clinical Trials 2012-13
•  
Anticipated  FDA Approval 2014

 (See graphic)


Slide 25

Comparative Selected Operating Results 2005-2010

 
Dec-10
  
Dec-09
  
Dec-08
  
Dec-07
  
Dec-06
  
Dec-05
REVENUES:
                      
Net sales
$       13,516,359
  
$       12,372,493
  
$       10,355,768
  
$        8,764,877
  
$       6,294,012
  
$       3,359,532
Research grant income
         3,188,344
  
      1,461,755
  
              693,803
  
              466,071
  
              208,468
  
              581,198
TOTAL REVENUES
       16,704,703
  
    13,834,248
  
         11,049,571
  
           9,230,948
  
           6,502,480
  
           3,940,730
Cost of sales
         8,604,004
  
      7,973,843
  
           7,197,850
  
           6,435,239
  
           4,894,208
  
           2,996,082
GROSS PROFIT
         8,100,699
48%
      5,860,405
42%
           3,851,721
35%
           2,795,709
30%
           1,608,272
25%
              944,648
OVERHEAD COSTS:
                      
Research and development expenses
         2,586,308
15%
      2,883,696
21%
           2,605,343
24%
           1,906,653
21%
           1,401,472
22%
           1,364,898
Selling, general and administrative expenses
         2,940,721
18%
      2,659,382
19%
           3,317,046
30%
           3,765,220
41%
           4,786,993
74%
           2,877,737
 
         5,527,029
  
      5,543,078
  
           5,922,389
  
           5,671,873
  
           6,188,465
  
           4,242,635
INCOME (LOSS) FROM OPERATIONS
         2,573,670
  
         317,327
  
         (2,070,668)
  
         (2,876,164)
  
         (4,580,193)
  
        (3,297,987)
OTHER INCOME (EXPENSES):
                      
Other income (expense)
              (3,923)
  
            (6,696)
  
                95,812
  
              120,862
  
              (57,464)
  
                21,867
Interest income
                4,147
  
             9,032
  
                34,403
  
              145,289
  
                29,532
  
                39,803
Interest expense
            (14,727)
  
          (10,603)
  
                (8,317)
  
              (16,879)
  
            (386,895)
  
              (15,683)
 
            (14,503)
  
            (8,267)
  
              121,898
  
              249,272
  
            (414,827)
  
                45,987
INCOME (LOSS) BEFORE INCOME TAXES
         2,559,167
  
         309,060
  
         (1,948,770)
  
         (2,626,892)
  
     (4,995,020)
  
    (3,252,000)
Income taxes
              45,823
  
                   -
  
                       -
  
                       -
  
                       -
  
                       -
NET INCOME (LOSS)
    2,513,344
15%
    309,060
2%
     (1,948,770)
-18%
      (2,626,892)
-28%
    (4,995,020)
-77%
(3,252,000)
NET INCOME (LOSS) ATTRIBUTABLE TO COMMON STOCKHOLDERS
 $      2,513,344
15%
 $      309,060
2%
 $      (1,948,770)
-18%
 $      (8,272,202)
-90%
 $      (8,205,066)
-126%
$      (6,769,022)
Basic income (loss) per share
 $                0.04
  
 $            0.00
  
 $               (0.03)
  
 $               (0.57)
  
 $               (0.80)
  
 $               (0.88)
Diluted income (loss) per share
 $                0.04
  
 $            0.00
  
 $               (0.03)
  
 $               (0.57)
  
 $               (0.80)
  
 $               (0.88)
Weighted average number of shares outstanding, basic
       62,102,861
  
    61,946,435
  
         61,266,954
  
         14,608,478
  
         10,293,168
  
           7,705,782
Weighted average number of shares outstanding, diluted
       70,920,915
  
    75,041,932
  
         61,266,954
  
         14,608,478
  
         10,293,168
  
           7,705,782

See Graphic


Slide 26


RAPID Tests for EARLIER Treatment

Investor Presentation

See Graphic