Attached files
| file | filename |
|---|---|
| EX-99.1 - PDF OF PRESENTATION - CHEMBIO DIAGNOSTICS, INC. | stkhldrmeetpresn.pdf |
| 8-K - FORM 8-K - CHEMBIO DIAGNOSTICS, INC. | form8_k.htm |
Slide 1:
June 2, 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:
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 4:
148% Revenue Increase in Net Sales to Inverness in 2009 vs. 2008
• US Rapid HIV Test Market Grew to Estimated 6MM
Tests in 2009
• Increased Traction in Higher Volume States
• Some State Funding Challenges in 2010 – Somewhat
Offset by CDC Appropriation
• November 2009 BPAC Meeting Provides Clarity for OTC Approval Requirements
Slide 5:
OEM: Progress on Four DPP OEM Contracts with FIOCRUZ
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•
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2009 Meeting Status:
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–
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Two Products Completed
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–
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One Submitted for Approval
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•
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2009-2010YTD Progress
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–
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Four Products Completed
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–
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Three Submitted for Regulatory Approval
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–
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Anticipate All Four Product Approvals in 2010
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•
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Significantly Longer Process than Expected
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Slide 6:
OEM: Multiplex DPP OEM Development Contract with BIO-RAD
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•
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2009 Meeting Status:
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–
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Not Mentioned
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2009-2010YTD Progress
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–
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Completing Product Development Phase in Current Q2 2010
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Slide 7:
OEM: Multiplex Influenza Test
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•
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2009 Meeting Status:
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–
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Mentioned Concept
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•
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2009-2010YTD Progress
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–
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Awarded $900,00 Development Contract in December 2009
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Slide 8:
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 9:
Additional R&D Activities
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•
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NIH $3MM 3 year Phase II Grant Awarded June 2009
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•
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Combination Antigen-Antibody Tests
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•
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Other Current and Pending Third Party Funded Projects
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Slide 10:
CHEMBIO BRANDED DPP® PRODUCT PIPELINE
DPP HIV 1/2 Screen Assay for Oral Fluid
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–
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2009 Meeting Status:
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•
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Completed Development; Submitted to PEPFAR
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–
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2009-2010YTD Progress
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•
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Approved by PEPFAR for all blood matrices & oral fluid
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Registrations pending in Brazil and other selected markets
Slide 11:
CHEMBIO BRANDED DPP® PRODUCT PIPELINE
DPP Syphilis Screen & Confirm
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–
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2009 Meeting Status:
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Completed Development; Submitted to WHO Study; Plan to Submit IDE
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2009-2010YTD Progress
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WHO Study Phase I Complete
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Contracts Pending for FDA clinical trials
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Submitting for CE Mark
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Slide 12:
CHEMBIO BRANDED DPP® PRODUCT PIPELINE
DPP HCV & HIV/HCV ORAL FLUID
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–
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2009 Meeting Status:
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•
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Prototype Developed and Submitted to CDC Study
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–
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2009-2010YTD Progress
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CDC Laboratory and Field Studies Concluded
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•
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Data to be Compiled and Published by CDC
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Slide 13:
CHEMBIO BRANDED DPP® PRODUCT PIPELINE
DPP INFLUENZA A/B Antigen Detection
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–
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2009 Meeting Status:
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Product in Concept Only
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2009-2010YTD Progress
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Completed Prototype
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Completed External Analytical Studies
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Plan to Complete Development 2010 and Submit 510(K) 2011
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Slide 14:
Chembio Branded Products Summary Status
(See PDF Image for Details)
Slide 15
Our Target Markets
U.S. Market Estimates for Current and Future Chembio Rapid Tests
Market estimates based on sales value to end users
(e.g., health professionals or consumers)
See image in PDF
Slide 16:
Selected Comparative Historical Financial Results
Q1-10 & Q1-09: 2006-2009
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Three Mos Ended
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For the Years Ended
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|||||
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$(000s)
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Mar 31 2010
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Mar 31, 2009
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2009
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2008
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2007
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2006
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Total Revenues
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$ 2,783
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$ 2,546
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$13,834
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$11,050
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$ 9,231
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$ 6,503
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Cost of sales
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1,477
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1,547
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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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Gross Profit
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1,306
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999
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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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46.9%
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39.2%
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42.4%
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34.9%
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30.3%
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24.7%
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R&D Expense
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801
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647
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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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SG&A Expense
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661
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676
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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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Operating Income (Loss)
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(156)
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(324)
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317
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(2,071)
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(2,876)
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(4,580)
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Other Inc. (Expense)
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(1)
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(1)
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(8)
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122
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249
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(415)
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Net Income (Loss) - Stkhldrs
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(157)
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(325)
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309
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(1,949)
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(2,627)
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(4,995)
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Pref. Stock Expenses
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-
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-
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-
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-
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5,645
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3,210
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Net Loss
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$ (157)
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$ (325)
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$ 309
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$(1,949)
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$(8,272)
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$(8,205)
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Net Income (Loss) - per Share
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$ (0.00)
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$ (0.01)
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$ 0.00
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$ (0.03)
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$ (0.57)
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$ (0.80)
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Avg. No. Shares (Millions)
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61.986
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61.945
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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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Working capital
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$ 1,431
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$ 1,334
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$ 1,494
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$ 1,664
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$ 3,229
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$ 5,113
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Total assets
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5,864
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5,697
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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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Total liabilities
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2,856
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3,429
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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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Equity (Deficit)
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3,008
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2,268
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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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Slide 17:
Selected Balance Sheet Data
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($000s)
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Balance Sheet Data
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Mar. '10
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Dec. '09
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Cash
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$ 798
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$ 1,068
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Accts. Receivable
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1,178
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1,776
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Inventories
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1,980
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1,556
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Other Current Assets
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285
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267
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Total Current Assets
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4,241
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4,667
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Net Fixed Assets
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850
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580
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Other Assets
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773
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1,068
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Total Assets
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5,864
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6,315
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Total Current Liab.
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2,810
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3,173
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Total Other Liab.
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46
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54
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Total Liabilities
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2,856
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3,227
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Total Equity
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3,008
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3,088
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Total Liabilities & Shareholders Equity
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$ 5,864
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$ 6,315
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Slide 18:
CEMI Selected Share Data
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Ticker Symbol (OTCBB)
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CEMI
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Price 4/30/10
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$0.230
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52 Week High
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$0.390
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52 Week Low
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$0.100
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Outstanding Shares (MM)
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62.0
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Market Capitalization (MM)
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$14.3
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Fully Diluted (FD) Shares (MM)
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70.7
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Management Holding (MM)-FD
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11.2
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Average Volume (3 Mos)
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130,000
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Options and Warrants (MM)
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Options (MM) (4.11MM held by mgmt. & board)
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5.96
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Warrants (MM) - 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 (MM)
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2.71
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Total Options & Warrants (MM)
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8.67
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Slide 19:
Chart (see PDF)
• 12 Months Ended May 31, 2010:
• Stock Price Increase of 77% from $.13 per share to $.23 per share.
• Daily Average, based on 3 Mos. Volume, Increased from 11,000 to 115,000.
Slide 20:
Actions Being Pursued to Enhance Shareholder Value
• Continue Delivering Improved
Fundamental Operating Results
• Validate DPP and Growth Plan through
Initial Commercial Opportunities
• Improve Stock Liquidity
– Impact of Distribution of Large Block of Shares
in QI – long term positive
– Consider Strategic Transactions to Qualify for
NASDAQ or AMEX to Develop Interest in CEMI
from a Broader Spectrum of Investors
Slide 21:
www.chembio.com