SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): May 30, 2018 (May 30, 2018)
CHEMBIO DIAGNOSTICS, INC.
(Exact name of registrant as specified in its charter)
Nevada
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0-30379
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88-0425691
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(State or other jurisdiction of Incorporation)
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(Commission File Number)
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(IRS Employer Identification Number)
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3661 Horseblock Road
Medford, NY 11763
(Address of principal executive offices)
631-924-1135
(Registrant’s Telephone Number)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
ITEM 7.01.
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REGULATION FD DISCLOSURE.
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On May 30, 2018, the Company posted a PowerPoint Presentation to its website titled “Corporate Presentation May 2018”. A copy of the presentation is provided herewith as Exhibit 99.1.
ITEM 9.01.
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FINANCIAL STATEMENTS AND EXHIBITS
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Exhibits.
99.1
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Presentation, dated May 30, 2018, titled “Corporate Presentation May 2018”.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
May 30, 2018
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Chembio Diagnostics, Inc.
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By:
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/s/ John J. Sperzel III
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John J. Sperzel III
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Chief Executive Officer
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EXHIBIT INDEX
Exhibit
Number
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Description
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Presentation, dated May 30, 2018, titled “Corporate Presentation May 2018”.
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© 2018 Chembio. All Rights Reserved. | # Corporate Presentation May 2018 © 2018 Chembio. All Rights Reserved. Page 1
Safe Harbor Statement 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. © 2018 Chembio. All Rights Reserved. Page 2
Our VisionTo reduce the incidence of disease globallyOur MissionTo develop and commercialize rapid, easy-to-use, and reliable point-of-care tests that improve diagnosis and monitoring of disease © 2018 Chembio. All Rights Reserved. Page 3
© 2018 Chembio. All Rights Reserved. | # Patented DPP® Technology Platform 99.8%Sensitivity1100% Specificity1 Offers uniqueness and broad global market application 1Based on fingerstick whole blood samples: DPP HIV 1/2 Assay Easy to useFingerstick blood / oral fluidResults in 15 minutesHighly sensitive and specificMultiplexing capabilitiesQuantitative Results © 2018 Chembio. All Rights Reserved. Page 4
EXPANDING…Our core sexually transmitted disease (STD) businessBUILDING…A broad tropical and fever disease portfolioLEVERAGING…Our DPP® technology and scientific expertise via collaborationsPREPARING…For additional growth with enhanced manufacturing capability Strategic Focus Executing on our key building blocks © 2018 Chembio. All Rights Reserved. Page 5
Expanding our Core STD Business Multiple organic growth drivers are moving the business BROADEN - expand product offering © 2018 Chembio. All Rights Reserved. Page 6
Sexually Transmitted Disease Market HIV and Syphilis affect ~50 million globally IMPORTANT GEOGRAPHIESU.S. – FDA approved, CLIA WaivedAfrica – WHO prequalifiedEurope – CE markedBrazil – ANVISA approvedMexico – COFEPRIS approved © 2018 Chembio. All Rights Reserved. Page 7
DPP® HIV 1/2 SURE CHECK® HIV Self Test A highly differentiated approach Addressing HIV-Syphilis Co-infection KEY ADVANTAGESEasy to use2.5 – μL15 blood sample Rapid results15-20 minute test timeReliable performanceSensitiveSpecific © 2018 Chembio. All Rights Reserved. Page 8
Building Tropical & Fever Disease Portfolio DPP® Malaria DPP® Dengue DPP® Zika DPP® Chikungunya DPP® Ebola DPP® Typhoid DPP® Fever Panel(Africa) DPP® Malaria-Ebola DPP® Dengue-Zika-Chikungunya DPP® Fever Panel(Asia) Single Tests Multiplex Tests Key advantages include sensitivity, specificity and multiplexing © 2018 Chembio. All Rights Reserved. Page 9
Opportunities in Established MarketsMalaria: 216M annual infectionsDengue: 390M annual infectionsEmerging Markets ZikaChikungunyaEbolaLassaMarburgLeptospirosisBurkholderiaRickettsia Tropical and Fever Disease Market Established markets and channels present significant opportunity © 2018 Chembio. All Rights Reserved. Page 10
Tropical and Fever Disease R&D funding from World-Leading Organizations: $7.3MM (’15-’17) DPP® Malaria Assay DPP® Dengue Assay DPP® Zika Assay DPP® Zika/Dengue/Chikungunya Assay DPP® Fever Panel Assay - Africa DPP® Fever Panel Assay - Asia DPP® Ebola Assay DPP® Malaria/Ebola Assay © 2018 Chembio. All Rights Reserved. Page 11
Technology Collaborations Why are global leaders choosing Chembio to solve their challenges? © 2018 Chembio. All Rights Reserved. Page 12 Deep scientific expertise with a proven technology platformSensitive and specificMultiplexing capabilitiesQuantitative resultsSuccessful track record developing DPP® tests with diverse collaboratorsGlobal commercial companiesGovernmentsNon-governmental organizationsExtensive experience achieving key regulatory approvalsU.S. FDA, WHO PQ, CE mark, ANVISA, COFEPRIS
Technology Collaborations Ongoing collaborations provide significant growth potential DPP® Concussion Assay DPP® Bovine TB Assay DPP® Cancer Assay DPP® “Undisclosed Biomarker” Assay Point-of-care infectious disease portfolio Perseus Science Group LLC Undisclosed Partner © 2018 Chembio. All Rights Reserved. Page 13
Technology Collaborations What opportunities do our technology collaborations provide? © 2018 Chembio. All Rights Reserved. Page 14 Expansion into new marketsCancer DiagnosticsConcussion / Traumatic Brain InjuryVeterinaryBroadening application from POC diagnostics to companion diagnosticsDrugsVaccinesCost-effective development funded by collaborators Note: all technology collaboration projects are under development
Preparing For Additional Growth Product, People, Process Building the product portfolioStrengthening the talent (Leadership, Board, Organization)Expanding manufacturing capacity (U.S. and Malaysia) © 2018 Chembio. All Rights Reserved. Page 15
© 2018 Chembio. All Rights Reserved. | # Revenue (millions) $12.5M cash and equivalents as of 3/31/2018 Q2 2016 Q2 2017 Q3 2016 Q3 2017 Q4 2016 Q4 2017 Q1 2017 Q1 2018 Financial Highlights Revenue Growth 38% LTM: $18.4M (Q2 ‘17) to $25.4M (Q1 ‘18) © 2018 Chembio. All Rights Reserved. Page 16 LTM: Last twelve months ended Q2’17 vs. LTM Q1’18
2018 Milestones and Next Steps Complete DPP® Malaria Assay development file registrationsComplete DPP® biomarker (AstraZeneca) development file registrationsSubmit DPP® Zika 510(k) with U.S. FDA launch in the U.S. marketFile DPP® Dengue registrations launch in APAC and LATAM marketsComplete DPP® Cancer development file registrations Driving new revenues © 2018 Chembio. All Rights Reserved. Page 17
Investment Highlights Investment Highlights Superior DPP® technology platform with broad applicationGrowing pipeline of products and markets Nimble global organization prepared to scale operationally © 2018 Chembio. All Rights Reserved. Page 18
© 2018 Chembio. All Rights Reserved. Page 19