Attached files
| file | filename |
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| EX-99.2 - PDF OF INVESTOR PRESENTATION - CHEMBIO DIAGNOSTICS, INC. | investorpresentation.pdf |
| EX-99.3 - PDF OF FACT SHEET - CHEMBIO DIAGNOSTICS, INC. | factsheet.pdf |
| 8-K - FORM 8-K FOR 1Q 2013 PR, INV. PRES, FACT S - CHEMBIO DIAGNOSTICS, INC. | form8_k.htm |
| EX-99.3 - EX. 99.3 FACT SHEET - CHEMBIO DIAGNOSTICS, INC. | exhibit99_3.htm |
| EX-99.1 - EX. 99.1 PR FIRST Q 2013 EARNINGS - CHEMBIO DIAGNOSTICS, INC. | exhibit99_1.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 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
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Develops, Manufactures & Markets Point-of-Care Diagnostic Tests (POCTs) Using Company's Patented DPP® Platform Technology
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>25% CAGR Product Sales Growth FY2009-2012
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Products Sold Globally
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Partnered with Leading License & Distribution Partners in U.S. & South America
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Recent FDA Approval of Oral Fluid HIV Test
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Strong Pipeline of POCTs
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Experienced Management Team
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Slide 4
POCTs - A Growing Global Market Converting Lab Tests to POC and Creating New Markets
In-Vitro Diagnostics Market $45 Billion
Global Point-of-Care Test Market $10 Billion
Current Capabilities:
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Lateral Flow Technology Single parameter tests
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DPP® Technology Enabling Improved Sensitivity, Multiplexing
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R&D: Signal Enhancement Features
Potential New Capabilities Being Assessed : Molecular Amplification Technologies
Slide 5
Chembio’s Pipeline - $850MM Total Addressable Market
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Chembio Pipeline POCT
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Total Market Opportunity
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Targeted Launch
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US HIV( Oral Fluid, 4th Generation)
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$ 75 MM
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Q4-2013 (Oral Fluid), 2015 (4th Generation)
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US Syphilis-HIV
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$ 75 MM
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2H- 2014
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US HCV
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$100 MM
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2015
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US OTC-HIV
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$100 MM
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2015-2016
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US Veterinary (OEM)
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$100 MM
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2014
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International
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$400 MM
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2013-2016
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Total
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$850 MM
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2013-2016
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See graphic
Slide 6
Chembio Diagnostics – Current Revenues & Markets
2012 - $25.6MM Revenue Business, $1.45MM Operating Income; Profitable Q1 2013
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~50% of Revenue: Lateral Flow HIV Tests
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25% Share of $75MM US Market
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Participate in $250MM Ex-US Rapid HIV Professional Test Market
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New HIV Self-Testing Market Opportunity
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~40% of Revenue: Patented POCT Platform
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Oral Fluid HIV Test FDA Approved 12/2012 & Five DPP® Products Approved and Successfully Launched in Brazil- 2011 - 2012
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Significant Developments for Single and Multiplex DPP® POCTs
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~10% Other Products, Grants
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Slide 7
Anticipated Developments - 2013-2015
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Oral Fluid HIV Test CLIA Waiver & Launch
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Direct Distribution in Public Health for Pipeline of Complementary Products
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Expanding International Revenues for Lateral Flow and DPP® Products
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FDA Submission & Approval of Two POCT Multiplex Syphilis Tests Based on DPP® Technology
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Development & FDA Approval of Multiplex Antigen/Antibody DPP® Tests for HIV and HCV
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FDA Approval of At-Home HIV Test
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Contract Development & OEM Partnerships – e.g., Veterinary, Tropical diseases
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Slide 8
Chembio Current POCT Market Opportunities
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HIV Rapid POCTS
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~50,000 New Infections in US – 2012; 2.5 MM Worldwide
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Routine Testing USPSTF Recommendation
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CEMI Only Company with 3 FDA-Approved Tests
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CEMI Tests Designated in Selected International Protocols
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Syphilis Rapid POCTS– New Market Opportunity
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Up to 70% HIV-Syphilis Co-Infection in MSM
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All HIV+ Need be Tested for Syphilis, & Vice Versa
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CEMI Has Two Unique POCTs – Anticipate 2014 Launch
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Hepatitis-C Rapid POCT– New Market Opportunity
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70MM U.S. Baby Boomer Screening Opportunity; New Therapeutics
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Product in Development
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Slide 9
DPP® - Chembio’s Patented POCT Platform Technology
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Proprietary Platform Technology that Uniquely Enables Multiplexing for Higher Value Tests
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Increases Sensitivity as Compared with Lateral Flow Technology
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Validated with Numerous Partners, Regulatory Agencies
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Bio-Rad Laboratories, Inc. CE Marked HIV Confirmatory Test, April 2013
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Patents Issued in US and Multiple Countries, Continuing Prosecution & Expansion of IP
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See graphics
Slide 10
Two FDA-Approved Lateral Flow Rapid HIV Tests Sold Globally
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Utilize In-Licensed Lateral Flow Technology
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Large International Screening Programs (PEPFAR)
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Significant Potential New International Opportunities Pending
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In US Sold Exclusively through Alere (Clearview Brand)
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2012 Sales to Alere $7.8MM
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Q1 2013 Sales to Alere $2.6MM
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See Graphic
Slide 11
DPP HIV®1/2 Test for Use with Oral Fluid or Blood Samples
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First FDA-Approved Product on DPP® (Dec. 2012)
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Center for Biologics Evaluation and Research (CBER) PMA Approved, CLIA Waiver Pending
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Improved Sensitivity v. Market Leader*
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Earlier Detection of Seroconverting Patients
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Proprietary SampleTainer™ Sample Collection System
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*Study Sponsored by CDC Global AIDS Program
See Graphics
Slide 12
U.S. HIV Self-Testing “OTC” Opportunity
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Chembio Uniquely Positioned
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Assessing Market Size and Best Approach
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Filing IDE Early 2013 for Sure Check HIV
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Pre-IDE Self-Testing Studies Show 100% Accuracy (n=300)
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Slide 13
Collaboration with FIOCRUZ in Brazil
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First Commercial Success with DPP®
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Contracts with Supplier to Brazilian Federal Ministry of Health
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$7MM of Potential Additional Purchases (~$16MM Revenues 2011-Q1'13) for Five DPP® Products - may be exceeded
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Expect Tech Transfer & Conversion to License 2013-14
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Potential New Products & Partnerships in Brazil
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See Graphics
Slide 14
DPP® Syphilis Screen & Confirm & HIV-Syphilis Multiplex Tests
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Large Global Market Opportunity for Pre-Natal and MSM Screening
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Anticipated FDA Submissions in 2013, with 2014 Clearances
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Additional Products for Public Health Channel
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Leveraging DPP® Multiplexing Features
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See Graphics
Slide 15
Pipeline: Rapid Hepatitis C Point-of-Care Diagnostic
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Data Published in Journal of Clinical Virology showed good performance of Chembio's 1st Generation Prototype Assay
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Completed Feasibility to Establish Performance Comparable to Only POCT HCV Test – 2013 R&D to incorporate additional value-added features
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Recent CDC recommendations for testing on everyone born between 1945-1964
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Anticipated Timeline
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Development & Clinical Trials – 2013-2014
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US Market Launch Anticipated - 2015
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See Graphic
Slide 16
Selected Financial Data FY2008 –2012
Reporting Record Revenues Again for FY2012
(in 000’s)
2012
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Total Revenue $25,611
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Product Revenue $24,327
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Gross Profit $10,790
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R&D Expense* $4,486
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Pre-Tax Income $1,451
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* Non-recurring 2010 $1.5MM R&D Credit from the Affordable Care Act – excluded from 2010 R&D Exp. & 2010 Pre-Tax Income
See Graphic
Slide 17
Strong Revenue & Operating Income Growth Q1 and Years ended 2013 and 2012
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3 Mos Ended
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3 Mos Ended
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Year Ended
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Year Ended
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In (000’s)
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March 31, 2013
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March 31, 2012
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2012
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2011
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Net Product Revenues
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$ | 6,313 | $ | 6,363 | $ | 24,327 | $ | 17,422 | ||||||||||||||||||||||||
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Non-Product Revenues
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$ | 365 | $ | 290 | $ | 1,283 | $ | 1,966 | ||||||||||||||||||||||||
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TOTAL REVENUES
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$ | 6,678 | $ | 6,653 | $ | 25,610 | $ | 19,388 | ||||||||||||||||||||||||
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GROSS MARGIN
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$ | 2,694 | 40 | % | $ | 3,333 | 50 | % | $ | 10,790 | 42 | % | $ | 9,390 | 48 | % | ||||||||||||||||
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OPERATING COSTS:
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Research and Development exp
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$ | 1,045 | 16 | % | $ | 1,379 | 21 | % | $ | 4,486 | 18 | % | $ | 4,878 | 25 | % | ||||||||||||||||
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Selling, G&Administrative exp
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$ | 1,162 | 17 | % | $ | 1,234 | 19 | % | $ | 4,852 | 19 | % | $ | 3,424 | 18 | % | ||||||||||||||||
| $ | 2,207 | $ | 2,613 | $ | 9,338 | $ | 8,302 | |||||||||||||||||||||||||
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INCOME FROM OPERATIONS
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$ | 487 | $ | 720 | $ | 1,452 | $ | 1,088 | ||||||||||||||||||||||||
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OTHER INCOME (EXPENSES):
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$ | 1 | $ | (1 | ) | $ | (2 | ) | $ | (12 | ) | |||||||||||||||||||||
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NET INCOME-Before Taxes
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$ | 488 | 7 | % | $ | 719 | 11 | % | $ | 1,450 | 6 | % | $ | 1,076 | 6 | % | ||||||||||||||||
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Income tax (benefit) provision
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$ | 171 | $ | 286 | $ | 509 | $ | (5,133 | ) | |||||||||||||||||||||||
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NET INCOME
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$ | 317 | 5 | % | $ | 433 | 7 | % | $ | 941 | 4 | % | $ | 6,209 | 32 | % | ||||||||||||||||
Slide 18
CEMI Selected Share & Balance Sheet Data
(in millions except per share and daily volume data)
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Ticker Symbol (NASDAQ)
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CEMI
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Price 04/30/13
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$4.53
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52-Week High
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$5.80
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52-Week Low
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$3.61
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Outstanding Shares
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9.29
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Market Capitalization
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$42.07
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Fully Diluted Shares
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10.01
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Management Holding
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1.62
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Average Daily Volume (3 months)
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32,000
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Average Daily Volume (1 month)
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37,800
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Options
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Amt.
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Avg. Ex. Price
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585K held by Mgmt. & Board
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725K
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$2.42
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($ in 000s)
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Mar’13
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Dec ‘12
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Dec ‘11
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Cash
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$ | 2,599 | $ | 2,952 | $ | 3,011 | ||||||
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Total Current Assets
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11,234 | 11,009 | 8,992 | |||||||||
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Total Assets
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$ | 17,473 | $ | 17,335 | $ | 15,486 | ||||||
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Total Current Liabilities
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3,213 | 3,378 | 2,858 | |||||||||
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Total Liabilities
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3,213 | 3,460 | 2,991 | |||||||||
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Total Equity
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14,260 | 13,875 | 12,495 | |||||||||
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Total Liabilities & Stockholders’ Equity
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$ | 17,473 | $ | 17,335 | $ | 15,486 | ||||||
See Graphics
Slide 19
Leadership
Executive Joined Company:
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Lawrence Siebert
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Chairman & CEO
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2002
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Richard Larkin
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CFO
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2003
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Javan Esfandiari
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SVP R&D
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2000
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Tom Ippolito
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VP Regulatory, Clinical, QA/QC
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2005
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Sharon Klugewicz
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VP QA/QC & Technical Operations
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2012
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Rick Bruce
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VP Operations
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2000
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Michael Steele
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VP Sales Marketing & Bus. Dev.
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2012
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Independent Directors Joined Board:
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Gary Meller, MD, MBA
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Katherine Davis, MBA
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Barbara DeBuono, MD, MPH
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Peter Kissinger, Ph.D
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2011 |
Slide 20
Organization & Facility
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FDA & USDA- Approved Development & Manufacturing Facility
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All Company Operations in 30,600 Sq. Ft. Leased Facility in Medford, NY
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Total Employment: Approx. 171
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Reg. & Clinical QA &QC
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15
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SG&A
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11
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Research & Development
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29
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Operations
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116
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See Graphics
Slide 21
Investment Summary
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Develops, Manufactures & Markets Point-of-Care Diagnostic Tests (POCTs) Using Company's Patented DPP® - A Platform POCT Technology
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>25% CAGR Product Sales Growth FY2009-2012
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Products Sold Globally
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Partnered with Leading License & Distribution Partners in U.S. & South America
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Recent FDA Approval of Oral Fluid HIV Test
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Strong Pipeline of POCTs
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Experienced Management Team
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See Graphic
Chembio Diagnostics, Inc.
RAPID tests for EARLIER treatment