8-K

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	0-30379	88-0425691
(State or other jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification Number)

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:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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. REGULATION FD DISCLOSURE.

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. FINANCIAL STATEMENTS AND EXHIBITS

Exhibits.

99.1 Presentation, dated May 30, 2018, titled “Corporate Presentation May 2018”.

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	Chembio Diagnostics, Inc.
	By:	/s/ John J. Sperzel III
		John J. Sperzel III
		Chief Executive Officer

EXHIBIT INDEX

Exhibit Number	Description
99.1	Presentation, dated May 30, 2018, titled “Corporate Presentation May 2018”.

EX-99.1

Exhibit 99.1

   © 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