Attached files
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EX-99.1 - PDF OF INVESTOR PRESENTATION - CHEMBIO DIAGNOSTICS, INC. | investorpresentation.pdf |
8-K - FORM 8-K - CHEMBIO DIAGNOSTICS, INC. | form8k.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 Participating in $10 billion POC test market
|
·
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Partnered with leading license and distribution partners in U.S. and South America
|
·
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Robust pipeline of POC diagnostics for infectious diseases based on lateral flow and proprietary DPP® platforms
|
·
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New opportunities for strategic partnerships with HIV Self-Tests, Hepatitis-C, Multiplex DPP® POC Testing Products
|
·
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Record Revenues and Income in 2009-2012YTD
|
·
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Seasoned management team with relevant industry and financial experience
|
Slide 4
Financial Summary - FY2009-2011 Results
•
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Product Revenue Growth of 40.8% over period to $17.4MM in 2011
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•
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Gross Margin Growth of 60% over period to $9.4MM in 2011
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•
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Non-Recurring Items Included in Net Income
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‐
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$1.5MM QTDP grant in 2010 credited to R&D expense
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‐
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$.3MM 2010 Expense related to possible strategic transaction
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‐
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2011 – Recognition of deferred tax asset valuation allowance of $5.1MM
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See Graphic
Slide 5
Three Months Ended March 31, 2011 & 2012 Selected Financial Results
See Graphic
Slide 6
Our Business Strategy
·
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ESTABLISH Chembio-DPP® Brand Serving Public Health & Related POCT Market Opportunities
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·
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CONTINUE to Increase Revenue and Profitability Growth to Drive Shareholder Value
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·
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COLLABORATE to Address New Market Opportunities by Leveraging our IP, Core Development and Manufacturing Competencies
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Slide 7
POCT’s – A Growing Global Market
Converting Lab Tests to POC and Creating New Markets
·
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Rapid HIV Test Markets -$200MM Globally
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·
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Potential HIV OTC (Self-testing) Market Estimated at >$250MM
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·
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Other New POCT Markets Targeted by Chembio
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--Hepatitis-C POCT Market
·
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Estimated at >$250MM
|
·
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R&D, Initial External Studies Completed
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--Syphilis POCT Market
·
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Estimated $75MM
|
·
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DPP® Syphilis Screen & Confirm Tests in EU and Brazil; U.S. Clinical Studies
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--Veterinary POCT
See Graphic
Slide 8
Product Portfolio At a Glance In-Licensed Lateral Flow Technology
See Graphic
Slide 9
Product Portfolio At a Glance Chembio Patented Dual Path Platform Technology
See Graphic
Slide 10
FDA-Approved Lateral Flow HIV Tests Sold Globally
Essential Tool in Prevention Efforts Globally
‐
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50,000 new cases of HIV annually still in U.S.
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‐
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Estimated that >20% of HIV-positive individuals in U.S. unaware of their status
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Marketed Exclusively in U.S. Professional Market by Alere, Inc. (NYSE: ALR)
‐
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Chembio’s U.S. market sales (to Alere) increased by 36.5% in 2011 to $7.2MM
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‐
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Estimated 20% U.S. market share
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‐
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Sold through distribution ex-U.S.
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Pre-IDE Studies Ongoing for OTC “Barrel” HIV Test
See Graphics
Slide 11
FDA’s BPAC* Recommended Approval Of In-Home HIV Test *Blood Products Advisory Committee
·
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Will Help Avert More Infections By Enabling Self-testing
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·
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Chembio Is Uniquely Positioned To Participate In This New Market
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·
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Barrel Product Currently Sold In U.S, Professional Market By Alere Already Unitized
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·
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Anticipate Receiving FDA Investigational Device Exemption In 2012 To Begin Studies In 2013
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See Graphic
Slide 12
Chembio Patented Technology: Dual Path Platform (DPP®)
A Patented Platform Technology with a Multitude of Potential Diagnostic Applications
Improves Performance (Sensitivity and Specificity)
‐
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Features Independent Sample Path and Direct Binding
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‐
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Enables Improved Multiplex Products
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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 13
OEM Collaboration with Brazil’s Oswaldo Cruz Foundation (FIOCRUZ) for DPP® - 5 Products Approved 2010-2011
•
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Five Contracts with Aggregate $23MM of Minimum Purchases, All Products Approved in Brazil 2010-11
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•
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$4.3MM Revenues in 2011 >$9MM Anticipated in 2012
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•
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Possible New Products and Collaborations with FIOCRUZ & Others in Brazil
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See Graphic
Slide 14
Branded Product : DPP® HIV Screening Assay For Use with Oral Fluid or Blood Samples
•
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Clinical Trials Being Completed
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•
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Anticipated FDA PMA Approval in 2012
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•
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Market Launch 2013
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•
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Improved Performance & Unique Features
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See Graphic
Slide 15
U.S. Rapid HIV Test Market* - Solid Growth Since 2006 with New CDC Testing Recommendations
Complete
(U.S.) Sure Check®,(Intl)
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HIV 1/2
STAT-PAK®
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DPP®
HIV Screen
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OraQuick® Advance
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Uni-Gold®
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Manufacturer
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Chembio
Medford, NY
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Chembio
Medford, NY
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Chembio
Medford, NY
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Orasure Bethlehem, PA
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Trinity Biotech, Dublin Ireland
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FDA Approval Date
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2006
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2006
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Clinical trials 98% Completed
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2003
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2003
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Technology
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Lateral Flow & Unitized Barrel Device
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Lateral Flow
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DPP® Technology & Closed Sample Vial System
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Lateral Flow
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Lateral Flow
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Est. US Market Shr.
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8%
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12%
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N/A
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65%
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15%
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Sample Types
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All Blood Matrices
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All Blood Matrices
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Oral Fluid &
All Blood Matrices
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Oral Fluid, Whole Blood, Plasma; not serum
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All Blood Matrices
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True IgG Control
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Yes
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Yes
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Yes
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Yes
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No
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Sample Size
(in microliters)
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2.5
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5
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5
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5
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40
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HIV-2
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Yes
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Yes
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Yes
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Yes
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No
|
Slide 16
Branded Product: DPP® Syphilis Screen & Confirm
•
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First Dual POCT for Syphilis Enables Confirmation & Treatment At POC
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•
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CE Marked October 2011, International Distribution being Established
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•
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US 510(K) Clinical Trials 2012
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Developed in collaboration with the U.S. Centers for Disease Control
See Graphic
Slide 17
Three Months Ended March 31, 2012 & 2011, Years Ended Dec. 2011 & 2010
Selected Financial Results
in (000's)
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3 Mo. Mar. 31, 2012
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3 Mo. Mar. 31, 2011
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Y/E Dec. 31, 2011
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Y/E Dec. 31, 2010
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||||||||||||||||||||||||||||
Net Product Revenues
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$ | 6,363 | $ | 3,015 | $ | 17,422 | $ | 13,516 | ||||||||||||||||||||||||
Non-Product Revenues
|
290 | 621 | 1,966 | 3,188 | ||||||||||||||||||||||||||||
TOTAL REVENUES
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$ | 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
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1,379 | 12 | % | 1,290 | 35 | % | 4,878 | 25 | % | 2,586 | 15 | % | ||||||||||||||||||||
Selling, general and administrative expense
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1,234 | 19 | % | 775 | 21 | % | 3,424 | 18 | % | 2,941 | 18 | % | ||||||||||||||||||||
2,613 | 2,065 | 8,302 | 5,527 | |||||||||||||||||||||||||||||
INCOME FROM OPERATIONS
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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 18
CEMI Selected Share & Balance Sheet Data
(in millions except per share and daily volume data)
Ticker Symbol (OTC-QB)
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CEMI
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Price 4/30/12
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$0.490
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52-Week High
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$0.570
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52-Week Low
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$0.210
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Outstanding Shares
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63.9
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Market Capitalization
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$31.3
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Fully Diluted Shares
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69.7
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Management Holding
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12.5
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Average Daily Volume (3 months)
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32,500
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($ in millions)
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Mar’12
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Dec'11
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Dec. '10
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Cash
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$ 2,954
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$ 3,011
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$ 2,136
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Total Current Assets
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10,033
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8,992
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7,637
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Total Assets
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$16,360
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$ 15,486
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$ 9,086
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Total Current Liabilities
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3,133
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2,858
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3,076
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Total Liabilities
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3,254
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2,991
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3,277
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Total Equity
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13,106
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12,495
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5,809
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Total Liabilities & Stockholders’ Equity
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$16,360
|
$ 15,486
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$ 9,086
|
Options
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Amt.
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Avg. Ex. Price
|
|
4.31MM held by Mgmt. & Board
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5.82MM
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$0.229
|
Slide 19
Anticipated Milestones 2012-13
Product Revenues & Operating Results
•
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Full Year of New Products Launched in Brazil through FIOCRUZ
|
•
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Launch of DPP® HIV & Syphilis Tests in Global & US Markets
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•
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Increased Lateral Flow HIV Test Sales in U.S. & Global Markets
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Potential New Products & Marketing Collaborations
•
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Developments Related to Potential New Branded and/or OEM Products & Related Strategic Collaborations
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Development Programs
•
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DPP® HIV Oral Fluid Test
|
‐
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Milestones toward FDA Approval
|
•
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Sure Check HIV OTC
|
‐
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IDE, Clinical Trials
|
•
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Hepatitis-C Product
|
‐
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Development, Studies
|
•
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Syphilis Screen & Confirm
|
•
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Others
|
‐
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HIV/Syphilis Combo
|
‐
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New Multiplex Tests
|
Slide 20
Organization & Facility
•
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FDA & USDA- Approved Development & Manufacturing Facility
|
•
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28,000 Sq. Ft. Leased Facility in Medford, NY
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Total Employment: Approx. 170
Reg. & Clinical QA &QC
|
15
|
SG&A
|
11
|
Research & Development
|
29
|
Operations
|
116
|
Slide 21
Leadership
Executive Joined Company:
Lawrence Siebert
|
Chairman & CEO
|
2002
|
Richard Larkin
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CFO
|
2003
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Javan Esfandiari
|
SVP R&D
|
2000
|
Tom Ippolito
|
VP Regulatory, Clinical, QA/QC
|
2005
|
Rick Bruce
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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 22
Investment Highlights
‐
|
Develops, Manufactures & Markets Point-of-Care Diagnostic Tests Participating in $10 billion POC test market
|
‐
|
Partnered with leading license and distribution partners in U.S. and South America
|
‐
|
Robust pipeline of POC diagnostics for infectious diseases based on lateral flow and proprietary DPP® platforms
|
‐
|
New opportunities for strategic partnerships with HIV Self-Tests, Hepatitis-C, Multiplex DPP® POC Testing Products
|
‐
|
Record Revenues and Income in 2009-2012YTD
|
‐
|
Seasoned management team with relevant industry and financial experience
|
Slide 23
Chembio Diagnostics, Inc.
RAPID tests for EARLIER treatments
Thank You
Additional Slides
Slide 24
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
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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 25
Revenue Growth by Category: 2009-2011
See Charts/Graphic
Slide 26
Potential Impact of OEM & Branded Products on Revenue*
See Graphic
May 2012