Attached files
| file | filename |
|---|---|
| EX-99.2 - INVESTOR PRESENTATION PDF - CHEMBIO DIAGNOSTICS, INC. | investorpresentation.pdf |
| EX-99.3 - FACT SHEET PDF - CHEMBIO DIAGNOSTICS, INC. | factsheet.pdf |
| 8-K - FORM 8-K FOR PR OF 5-6-10 - CHEMBIO DIAGNOSTICS, INC. | form8_k.htm |
| EX-99.3 - FACT SHEET WORD - CHEMBIO DIAGNOSTICS, INC. | ex99_3.htm |
| EX-99.1 - PRESS RELEASE OF 5-6-10 - CHEMBIO DIAGNOSTICS, INC. | ex99_1.htm |
Slide 1:
Investor Presentation
April 2010
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:
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Medford, NY Manufacturer of Point of Care Rapid Diagnostic Tests
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2009 Total Revenues of $13.8MM - $309K Net Income v. $11.0MM Rev. - $1.9MM Net Loss in 2008
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Five Year Revenue CAGR of 33%
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148% Revenue Increase, to $5.3MM in 2009, of FDA Approved Rapid HIV Tests Marketed in U.S. by Inverness Medical
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New OEM & Branded Product Pipeline Utilizing Chembio’s Patented DPP® Technology
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Slide 4:
Organization & Management Team
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Lawrence Siebert, CEO & Chairman
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Richard Larkin, CFO
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Javan Esfandiari, Sr. VP R&D
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Rick Bruce, VP Operations
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Tom Ippolito, VP Reg., QA/QC
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Sandy Speer, Dir. Client Serv.
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Dr. Gary Meller, Director
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Katherine Davis, Director
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Total Employment 101
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S, G&A 7
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Ops. 69
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R&D 18
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Reg. & Clinical, QA & QC 7
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Slide 5:
Regulatory Approvals Provide Access to
Large, Diverse & Global POCT Markets
Two FDA-Approved PMA’s
USDA-Approved Facility & Product Licenses
ISO Certified for Global Markets
Slide 6:
$7B Global Point-of-Care Test (POCT) Market
Europe $3,254 (52%), U.S. Hosp. $1,772 (28%), U.S. Decentralized Sites $591 (9%), etc
At 7% Projected Increases, even with Large Low-Growth Segments (e.g., Glucose), Global POCT Market is Fastest Growing Segment of $39.5B In-Vitro Diagnostics Market, Projected to Reach $8.8B by 2012
Source: Independent Market Research Report
Slide 7:
POCT Market Drivers
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Reduce Patient Stays and Costs, Improve Patient Outcomes with Prompt & Early Diagnosis
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| – | Improves Therapeutic Intervention |
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Prevent Needless Admissions
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Simplify Testing Procedures to Reduce Testing Costs
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| – | Avoid Delays from Central Lab Batching |
| – | Eliminate Need for Return Visit |
Slide 8:
Our Current LF and Planned DDP®Products Participate in Large & Growing U.S. POCT Market Segments
2009
Market Segments &Annual Sales
Near Term Growth Rates for Selected Markets
(see PDF for More Details)
(see PDF for More Details)
Slide 9:
2009 Revenue Composition
2009 Total Revenue $13,834,248
LF-HIV, Int’l - $5,552,947 (40%), LF-HIV-U.S. - $5,240,000 (38%), Other - $960,016 (7%), R&D $1,339,859 (10%), DPP $619,530 (6%), Royalty Income $121,896 (1%).
Slide 10:
FDA Approved Rapid HIV Tests
Distributed in US Exclusively by Inverness Medical
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148% YTD Increase in 2009 -$5.3MM v. $2.1MM
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Gains Based Upon Market Expansion and Increased Market Share
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Competitive Features
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CLIA Waived
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Two Formats
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99.7% Sensitivity; 99.9% Specificity
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Proprietary Formulation Enables 24 Month Stability
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Strong Marketing Partner
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Slide 11:
Chembio’s Rapid HIV Tests
are Distributed Globally
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Approved for Procurements by UN,WHO, CDC/USAID (PEPFAR)
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Registered/Approved in several countries in South America, Asia, and Africa
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Slide 12:
PATENTED DUAL PATH PLATFORM (DPP®)
KEY DESIGN AND PERFORMANCE ADVANTAGES vs. LATERAL FLOW
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Independent Sample Flow Path Enables Improved Sensitivity & Use of More Challenging Sample Types
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Improved Multiplexing Facilitated by Direct Binding, Uniform Delivery of Samples
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US Patent #7,189,522. Patent Protection Pending Worldwide
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Slide 13:
DPP® HIV 1/2 Oral Fluid Assay
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$60MM/6MM UnitsUS Market Growth in 2009
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International Studies Completed in 2009
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US Clinical Trials Commenced Q1 2010
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Anticipate PMA approval mid-2011
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OTC Opportunity
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Slide 14:
DPP® Syphilis Screen & Confirm
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First POCT For Syphilis In US – Estimate $30MM Market
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Provides Better Indication Of Active Disease
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Enables Confirmation & Treatment At POC
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Pre-natal Testing
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• International Evaluation Ongoing
• Anticipate 510(K) Clearance in Early 2011
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Developed in collaboration with the U.S. Centers for Disease Control
Slide 15:
In Development: DPP® INFLUENZA
Multiplex Flu A & B Test & 6 Strain Immunity Test
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Large Established Market for Flu A&B tests
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Chembio’s First Antigen Detection Test with DPP
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Prototype Shows Improved Performance v. Established Tests
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In Addition: $900,000 Contract signed Dec. 2009 with CDC for 6-band Multiplex Immune Status Test
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Slide 16:
In Development: Hepatitis-C (HCV) & HIV/HCV Comb. Oral Fluid
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Estimated 3MM HCV Infections in US
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Only 22% Diagnosed
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25% Co-infection with HIV
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Major Cause of Liver Disease
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New therapeutics from Vertex, etc. will drive demand for Dx
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No HCV Point of Care Test in US
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Chembio Participating in Pre-Clinical CDC Study with both prototypes – Expect Data in First Half 2010
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Slide 17:
OEM Contracts with FIOCRUZ
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Four Products Under OEM Agreements with Bio-Manguinhos, Brazil
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Completed $8MM Tech. Transfer Program with Chembio 2004-2009
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Anticipate Regulatory Approval in Brazil of Three Products During First Half 2010
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Potential Annual Revenues of ~$3MM 2010-2012 (total $12MM)
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Slide 18:
OEM Products Overview
(See PDF Image for Details)
Three Year, $3MM Phase II NIH Grant for Leptospirosis Awarded June 2009. Several Other Grants Active and Additional Grant Applications Pending
Slide 19: Chembio Branded Products Pipeline
(See PDF Image for Details)
Slide 20: Selected Comparative Historical Financial Results
2005-2009
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For the Years Ended
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||||||||||||||||||||||
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(000s)
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2009
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2008
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2007
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2006
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2005
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|||||||||||||||||
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Total Revenues
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$
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13,834
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$
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11,050
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$
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9,231
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$
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6,503
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$
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3,941
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Cost of sales
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7,974
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7,198
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6,435
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4,894
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2,996
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Gross Profit
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5,860
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3,852
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2,796
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1,609
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945
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42.4
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%
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34.9
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%
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30.3
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%
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24.7
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%
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24.0
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%
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|||||||||||||
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R&D Expense
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2,884
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2,605
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1,907
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1,402
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1,365
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SG&A Expense
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2,659
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3,317
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3,765
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4,787
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2,878
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OOperating Income (Loss)
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317
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(2,071
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)
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(2,876
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)
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(4,580
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)
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(3,298
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)
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Other Inc. (Expense)
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(8
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)
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122
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249
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(415
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)
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46
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Net Income (Loss) - Stkhldrs
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309
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(1,949
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)
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(2,627
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)
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(4,995
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)
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(3,252
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)
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Pref. Stock Expenses
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-
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-
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5,645
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3,210
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3,517
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Net Income Loss
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$
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309
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$
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(1,949
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)
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$
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(8,272
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)
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$
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8,205
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)
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$
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(6,769
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)
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NNet Income (Loss) - per Share
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$
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0.00
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$
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(0.03
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)
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$
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(0.57
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)
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$
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(0.80
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)
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$
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(0.88
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)
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AAvg. No. Shares (Millions)
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61.946
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61.267
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14.608
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10.293
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7.705
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Working capital
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$
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1,494
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$
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1,664
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$
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3,229
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$
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5,113
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$
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831
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Total assets
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6,315
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5,915
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6,585
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7,907
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3,016
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Total liabilities
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3,227
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3,338
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2,322
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2,297
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1,964
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Equity (Deficit)
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3,088
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2,577
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4,263
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(940
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)
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1,053
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Slide 21:
Selected Comparative Quarterly Financial Results
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Three Mos Ended
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(000s)
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Dec. 30, 2009
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Dec. 30, 2008
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Total Revenues
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$
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3,551
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$
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2,451
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Cost of sales
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1,920
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1,836
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Gross Profit
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1,631
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615
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45.9
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%
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25.1
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%
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R&D Expense
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756
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653
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SG&A Expense
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657
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620
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Operating Income (Loss)
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218
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(658
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)
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Other Inc. (Expense)
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(1
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)
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108
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Net Income (Loss) - Stkhldrs
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217
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(550
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)
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Pref. Stock Expenses
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-
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-
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Net Income Loss
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$
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217
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$
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(550
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)
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Net Income (Loss) - per Share
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$
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0.00
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$
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(0.00
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)
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||||||
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Avg. No. Shares (Millions)
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61.951
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61.945
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Working capital
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$
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1,494
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$
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1,664
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||||||||
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Total assets
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6,315
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5,915
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Total liabilities
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3,227
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3,338
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Equity (Deficit)
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3,088
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2,577
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Slide 22:
Selected Balance Sheet Data
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($000s)
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Balance Sheet Data
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Dec '09
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Dec. '08
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Cash
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$1,068
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$1,212
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Accts. Receivable
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1,776
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809
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||||||
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Inventories
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1,556
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1,819
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||||||
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Other Current Assets
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267
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225
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||||||
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Total Current Assets
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4,667
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4,066
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||||||
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Net Fixed Assets
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580
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881
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Other Assets
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1,068
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968
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||||||
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Total Assets
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6,315
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5,915
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||||||
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Total Current Liab.
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3,173
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2,402
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||||||
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Total Other Liab.
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54
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936
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||||||
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Total Liabilities
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3,227
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3,338
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||||||
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Total Equity
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3,088
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2,577
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||||||
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Total Liabilities & Shareholders Equity
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6,315
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5,915
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Slide 23:
CEMI Selected Share Data
(see PDF for details)
| Ticker Symbol(OTCBB) | CEMI | ||
| Price 4/20/2010 | $0.225 | ||
| 52 Week High | $0.390 | ||
| 52 Week Low | $0.100 | ||
| Outstanding Shares(MM) | 62.0 | ||
| Market Capitalization | $14.0 | ||
| Fully Diluted (FD) Shares | 70.7 | ||
| Management Holding-FD | 11.2 | ||
| Average Volume(3 Mos) | 130,000 | ||
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Options and Warrants (MM)
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Avg. Ex. Price
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Options (4.11MM held by mgmt. & board)
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5.96
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Warrants - Exp.Dates
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10/6/2011
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2.64
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2/5/2012
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0.07
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Total Warrants
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2.71 | |
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Total Options & Warrants
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8.67 | |
Slide 24:
www.chembio.com