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):  March 14, 2018 (March 8, 2018)

CHEMBIO DIAGNOSTICS, INC.

(Exact name of registrant as specified in its charter)

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

ITEM 7.01.  REGULATION FD DISCLOSURE.

On March  8, 2018, the Company issued a press release entitled "Chembio Diagnostics Reports Fourth Quarter and Full Year 2017 Financial Results".   A copy of the press release is furnished herewith as Exhibit 99.1

On March 14, 2018, the Company posted a PowerPoint Presentation to their website entitled "Investor Presentation March, 2018."  A copy of the presentation is furnished herewith as Exhibit 99.2.

The information in this Item 7.01 of this Form 8-K is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section. The information in this Item 7.01 of this Form 8-K also shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except to the extent that the Company specifically incorporates it by reference.

ITEM 9.01.FINANCIAL STATEMENTS AND EXHIBITS

Exhibit Number	Description
99.1	Press Release entitled "Chembio Diagnostics Reports Fourth Quarter and Full Year 2017 Financial Results" dated March 8, 2018
99.2	Presentation entitled "Investor Presentation March 2018" dated  March 14, 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.

March 14, 2018          Chembio Diagnostics, Inc.

By:    /s/ John J. Sperzel III                                      

John J. Sperzel III

Chief Executive Officer

EXHIBIT INDEX

Exhibit Number	Description
99.1	Press Release entitled "Chembio Diagnostics Reports Fourth Quarter and Full Year 2017 Financial Results" dated March 8, 2018
99.2	Presentation entitled "Investor Presentation March, 2018" dated  March 14, 2018

EX-99.1

Chembio Diagnostics Reports Fourth Quarter and Full Year 2017 Financial Results

MEDFORD, NY, March 8, 2018 -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leader in point-of-care ("POC") diagnostic tests for infectious diseases, today reported financial results for the fourth quarter and full year ended December 31, 2017.

Recent Accomplishments & Highlights

· Achieved total revenue of $24.0 million of which net product sales were $19.3 million for the full year 2017, increases of 34% and 41% respectively, over prior year

· Received $8.5 million 2018 purchase commitment from Bio-Manguinhos in Brazil for DPP® HIV Assays and DPP® Leishmania Assays

· Won three-year, $15.8 million total contract value tender from the Ethiopian Pharmaceuticals Fund and Supply Agency to deliver HIV STAT-PAK® Assays between 2018-2020

· Received conditional award of $1.5 million to $4.9 million in 2018-2019 from UNICEF for DPP® Zika Systems

· Filed Premarket Approval Application for the DPP® HIV-Syphilis Assay and DPP® Micro Reader to the Food and Drug Administration, following completion of U.S. clinical trials

· Entered collaboration with AstraZeneca to develop a quantitative DPP® Assay to detect an undisclosed biomarker, from which Chembio will receive up to $2.9 million in R&D funding over 18 months

· Strengthened balance sheet with $11.0 million in net capital from underwritten public offering in February 2018

"We demonstrated strong financial performance and meaningful progress toward our strategic and operational objectives during the fourth quarter and full year 2017. We are particularly pleased with the strong growth in total revenue and product sales," said John Sperzel, Chembio's Chief Executive Officer. "Our DPP® platform is a cornerstone from which we can build and launch a meaningful pipeline of products, and as we enter 2018, we are well positioned to continue executing on several additional milestones."

Fourth Quarter 2017 Financial Results

Total revenues for the fourth quarter of 2017 were $6.0 million, an increase of 40.7% compared to the fourth quarter of 2016. Net product sales for the fourth quarter of 2017 were $4.9 million, an increase of 50.9% compared to the fourth quarter of 2016.  License and royalty and R&D, milestone and grant revenues for the fourth quarter of 2017 were $1.1 million, an increase of 8.8% compared to the fourth quarter of 2016.

Product gross margin for the fourth quarter of 2017 was $1.4 million, an increase of 97.9% compared to the fourth quarter of 2016. Gross product margin percent for the fourth quarter of 2017 was 29.5% compared to 22.5% for the fourth quarter of 2016.

Other costs and expenses, representing R&D and SG&A expenses, for the fourth quarter of 2017 were $4.6 million, an increase of 7.2% compared to the fourth quarter of 2016. The $0.3 million increase was primarily due to an increase in sales and marketing expenses and professional fees.

Net loss for the fourth quarter of 2017 was $2.0 million, or $0.16 per diluted share, compared with a net loss of $2.6 million, or $0.21 per diluted share, for the fourth quarter of 2016. 

Full Year 2017 Financial Results

Total revenues for 2017 were $24.0 million, an increase of 34.4% compared to 2016. Net product sales for 2017 were $19.3 million, an increase of 41.2% compared to 2016. License and royalty and R&D, milestone and grant revenues in 2017 totaled $4.7 million, an increase of 12.0% compared to 2016.

Gross product margin for 2017 was $6.4 million, an increase of 50.2% compared to 2016, the $2.1 million increase was primarily due to increased product sales volume. Gross product margin percent for 2017 was 33.1% compared to 31.2% for 2016.

Other costs and expenses, representing R&D and SG&A expenses in 2017 were $17.6 million, an increase of 9.7% compared to 2016. The $1.6 million increase was primarily due to an increase in sales and marketing expenses and professional fees.

Net loss for 2017 was $6.4 million, or $0.52 per diluted share, compared with net loss of $13.3 million, or $1.26 per diluted share, in 2016.

Cash and cash equivalents as of December 31, 2017 totaled $3.8 million.

Conference Call

Chembio will host a conference call today beginning at 4:30pm ET to discuss financial results and recent business highlights. Investors interested in listening to the call may do so by dialing (877) 407-0778 from the U.S. or (201) 689-8565 from outside the U.S.  To listen to a live webcast, please visit the Investor Relations section of Chembio's website at www.chembio.com. Following the call, a reply will be available on the Investor Relations section of the company's website for 90 days. A telephone replay will be available by dialing (877) 481-4010 from the U.S. or (919) 882-2331 from outside the U.S. using the conference ID: 26056 until 4:30pm ET on March 15, 2018.

About Chembio Diagnostics

Chembio Diagnostics, Inc. develops, manufactures, licenses, and markets rapid diagnostic tests in the growing $8.0 billion POC testing market. Chembio's patented DPP® technology platform offers significant advantages over traditional POC lateral-flow technologies and provides the Company with a robust pipeline of business opportunities in the areas of sexually transmitted disease, tropical and fever disease, and technology collaborations.

The Company markets its products directly and through third-party distributors under the brand names: DPP®, STAT-PAK®, SURE CHECK®, and STAT-VIEW®.

Headquartered in Medford, NY, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13485. Each of Chembio Diagnostic Systems Inc. and Chembio Diagnostics Malaysia Sdn Bhd is a wholly-owned subsidiary of Chembio Diagnostics, Inc. For more information, please visit: www.chembio.com.

Forward-Looking Statements

Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements, which are estimates only, 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 to obtain regulatory approvals in a timely manner, as well as 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.

(Tables to follow)

Investor Relations Contact

Lynn Pieper Lewis

Gilmartin Group

(415) 937-5402

investor@chembio.com

 

EX-99.2

Investor Presentation March 8, 2018

NASDAQ:CEMI

Rapid Tests for Earlier Treatment™™

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

Mission

To develop and commercialize simple, fast and reliable point-of-care diagnostic tests that improve diagnosis or monitoring of disease

Slide 4

Chembio's Dual Path Platform (DPP^®) Technology Next-Generation Point-of-Care Technology Platform

§ Patented point-of-care (POC) technology platform

§ Provides enhanced sensitivity vs. lateral flow technology

§ Allows multiplexing (i.e., multiple test results from a single patient sample)

§ Provides quantitative results when used with DPP^® Micro Reader

§ Adapts to multiple sample types (i.e., blood, oral fluid)

§ Applies to a range of diseases and markets

§ Includes unique sample collection device (i.e., SampleTainer^®)

See graphics

Slide 5

Chembio's Dual Path Platform (DPP^®) Technology

Leveraging Our Technology Platform to Enter New Markets

Three areas of Strategic Focus:

· Sexually Transmitted Disease Business

· Tropical and Fever Disease Business

· Technology Collaborations

DPP® Technology Platform

Slide 6

HIV and Syphilis Continue as Global Health Concerns Testing for co-infection important for pregnant women and MSM

United States (HIV)

· 1.1 million living with HIV

· 39,782 diagnosed with HIV

· ~1 in 7 (15%) unaware of HIV infection

United States (SYP)

· 88,042 18% increase in cases reported to CDC (2015-2016

Global (HIV)

· 36.7 million living with HIV

· 1.8 million Diagnosed with HIV

· ~1.0 million died of AIDS-related illnesses

Global (SYP)

· ~12 million new infections/year

Source: Centers for Disease Control & Prevention (CDC) website; World Health Organization (WHO) website Data as of 12/31/2016

Slide 7

Traditional Lateral Flow HIV ProductsSTAT-PAK ^® and SURE CHECK ^® HIV Assays

Product Features & Benefits

· FDA (PMA) approved, CLIA-waived

· CE marked, WHO pre-qualified

· 2.5 - 5.0 μL blood sample

· 15 - 20 minute test time

· Specificity: 99.9%, Sensitivity: 99.7%

Commercialization

· High quality brands, marketed globally since 2007

· Sold to Public Health Clinics, POLs, Hospitals, Self Test (EU)

· Distribution Partners US: Fisher, McKesson/PSS, H. Schein, Medline, Caribbean: Isla Lab

See graphics

Slide 8

Strengthening our Core STD BusinessDPP^® HIV-SYP and DPP^® HIV 1/2 Assays

§ DPP^® HIV-Syphilis Combo Assay

– Chembio has a history of leadership

• First to receive USAID, ANVISA (Brazil),   COFEPRIS (Mexico) approvals

– FIled application for FDA PMA Q1 2018 after completing U.S. clinical trials in Q4 2017

– Global screening opportunity:

• Pregnant women and MSM

§ DPP^® HIV 1/2 Assay

– Received FDA (PMA) approval (2013),

– Received CLIA-waiver (2014)

(blood and oral fluid)

– Superior performance vs. competitors

(sensitivity)

See graphics

Slide 9

Strengthening our Core STD BusinessDPP^® Syphilis Screen & Confirm and SURE CHECK ^® HIV Self Test

§ DPP^® Syphilis Screen & Confirm Assay

– Simultaneously and separately detects   treponemal and nontreponemal antibodies

– Screen and confirm in only 15 minutes, with a single drop of fingerstick blood, on a single test

– Sensitivity: 99.7%

§ SURE CHECK^® HIV Self Test (Ex-US)

– Simple, fast, reliable HIV assay

– Small sample: 2.5uL fingerstick

– Integrated sample collection device

– Sensitivity: 99.7%; Specificity: 99.9%

See graphics

Slide 10

Fever Diseases - A Growing Global Concern Malaria, Dengue, Zika, Chikungunya, Ebola, and Others

§ Mosquito-Borne Illnesses

– Mosquito à world's deadliest animal

– Responsible for 725,000 deaths/year

– Global geographic coverage

§ Established Fever Markets:

– Malaria:  214MM annual infections

– Dengue: 390MM annual infections

§ Emerging Fever Markets:

– Zika

– Chikungunya

– Ebola

§ Which Fever Threat Will We Face Next?

See graphics

Slide 11

Fever Disease - Product Development Chembio Collaborates with World Leading Organizations

DPP^® Malaria Assay- Bill & Melinda Gates Foundation

DPP^® Dengue Assay-RVR Diagnostics Sdn Bhd

DPP^® Zika Assay and DPP^® Zika/Dengue/Chikungunya Assay- BARDA, FIOCRUZ, CDC

DPP^® Fever Panel Assay – Asia- FIND

DPP^® Fever Panel Assay – Africa- The Paul G. Allen Family Foundation

DPP^® Ebola Assay and DPP^® Malaria/Ebola Assay - CDC

See graphics

Slide 12

Chembio is Well-Positioned to Address Zika Virus Key Regulatory Approvals: U.S. FDA EUA, CE mark, ANVISA

§ Local Zika Transmission

– 2015 (Brazil) à 2018 (~90 countries)

§ Who Needs to Be Tested?

– Pregnant women

– Residents and travelers (endemic areas)

§ Molecular (MDx) Test Limitations

– Laboratory test, venous sample

– Detects acute infections only - not antibodies

– High cost

§ Chembio Zika Test Advantage

– Convenience: POC test; fingerstick sample

– Detects antibodies (IgM/IgG)

– Quantitative results: DPP^® Micro Reader

– Time to result: 15 minutes

– Low cost compared to MDx tests

Source: Centers for Disease Control & Prevention (CDC) website

See graphics

Slide 13

Chembio is Well-Positioned to Address Zika Virus

§ Local Zika Transmission

– 2015 (Brazil) à 2017 (~60 countries)

§ Who Needs to Be Tested

– Pregnant Women

– Travelers to/from endemic Areas

– Others?

§ Molecular (MDx) Test Limitations

– Laboratory test, venous sample

– Detects acute infections only - not antibodies

– No immediate results

– High cost

§ Chembio Zika Test Advantage

– Convenience: POC Test; fingerstick sample

– Detects Antibodies (lgM/lgG)

– Time to Result: 15 minutes

– Low cost compared to MDX tests

Source: Centers for Disease Control & Prevention (CDC) website

See graphics

Slide 14

DPP^® Zika Assay Product Development Timeline Demonstrates Speed of Development and Scientific Expertise

§ DPP® Zika IgM/lgG Development/Commercialization Timeline

– Received PGAFF grant; initiated project DPP® Zika Project – 2/16

– Announced Zika collaboration with Bio-Manguinhos/Fiocruz (Brazil) – 3/16

– Completed initial testing; including 600 pregnant women – 4/16

– Announced regulatory filings with FDA-EUA, ANVISA – 5/16

– Announced regulatory filings with WHO-EUA, Cofepris, CE mark – 7/16

– Received CE mark (Europe, Caribbean)- 7/16

– Announced HHS/BARDA funding contract– 8/16

– Awarded CDC Surveillance Program: DPP® Zika/Dengue/Chikungunya (Peru, India, Guatemala, Haiti)- 9/16

– Received ANVISA approval, DPP® Zika Assay –11/16

– Successful INCQS Evaluation- 2017

See graphics

Slide 15

Ongoing Technology CollaborationsLeveraging Our Patented DPP^® Technology Platform

DPP^® "Undisclosed Biomarker" Assay- AstraZeneca

DPP^® Cancer Assay- Undisclosed Collaborator

DPP^® Bovine TB Assay- USDA

DPP^® Concussion Assay- Perseus Science Group LLC

Slide 16

Chembio's Global Organization Expanding Commercial and Manufacturing Operations

Manufacturing Operations

Facilities: 65,000 sq. ft.

Capacity: 25MM tests

Certification: ISO 13485

Regulatory Compliance: (FDA, WHO, USDA, ANVISA)

See graphics

Slide 17

Selected Financial Highlights

Quarter  Ended (in 000's)       9 Months Ended (in 000's)

	Dec. 31, 2017			Dec. 31, 2016			Dec. 31, 2017			Dec. 31, 2016
Net Product Revenues	$	4,869		$	3,227		$	19,322		$	13,680
Total Revenues	$	5,988		$	4,255		$	24,015		$	17,869
Gross Margin	$	1,436		$	725		$	6,401		$	4,263
Loss from Operations	$	(2,084	)	$	(2,574	)	$	(6,483	)	$	(7,572	)
Net Loss	$	(1,998	)	$	(2,558		$	(6,372	)	$	(13,347	)*
Accounts Receivable Net	$	2,085		$	3,384		$	2,085		$	3,384
Cash (as of end of period)	$	3,790		$	10,554		$	3,790		$	10,554

*The net loss in 2016 includes the non-cash impact of a $5.8 million valuation allowance on the Company's deferred tax asset.

Slide 18

Investment Highlights

§ A global leader in point-of-care (POC) infectious disease

– Sales & marketing organization in U.S., LATAM, Europe, Africa, and APAC

– Manufacturing operations in the U.S. (NY) and Malaysia

§ Groundbreaking patented DPP^® technology platform

– Superior sensitivity and specificity vs. traditional lateral flow technology

– Multiple tests from a tiny (10μL) drop of fingertip blood (multiplexing)

§ Robust pipeline of new DPP^® POC assays in development

– DPP^® HIV-Syphilis Combination Assay (U.S. version)

– DPP^® Fever Assays (Malaria, Dengue, Zika, Chikungunya, Ebola, + others)

– DPP^® Technology Collaborations (Cancer, Concussion, Undisclosed, Bovine TB)

§ Multiple high-value collaborations

– U.S. Government: HHS/ASPR/BARDA, CDC: DPP^®Zika

– AstraZeneca: DPP^® "Undisclosed Biomarker"

– Bill & Melinda Gates Foundation: DPP^® Malaria

– Paul G. Allen Ebola Program: DPP^® Fever Panel - Africa

– FIND: DPP^® Fever Panel - Asia

Slide 19

Experienced Executive Leadership Team

Executive:  John J. Sperzel III,   President &CEO

Joined Chembio: 2014

Previous Experience: 2011-2013, President and CEO of ITC/Accriva; 1987-2011 Axis-Shield, Bayer Diagnostics, Instrumentation Laboratory and Boehringer Mannheim

Executive:  Neil A. Goldman, CPA  Chief Financial Officer; Executive Vice President

Joined Chembio: 2017

Previous Experience: 2015-2017, CFO of J.S. Held; 1989-2015 Unwired Technology LLC/Delphi Corp., EPPCO Enterprises, Ernst & Young

Executive:  Javan Esfandiari, M.S.  Chief Science and Technology Officer; Executive Vice President

Joined Chembio:  2000

Previous Experience: 1997-2000, Co-founder of Sinovus Biotech AB (Sweden), acquired by Chembio in 2000; 1993-1997 R&D Director of On-Site Biotech

Executive:  Sharon Klugewicz, M.S., President, Americas Region

Joined Chembio: 2012

Previous Experience: 2009-2012, Sr. VP Scientific & Laboratory Services of Pall Corporation; 1991-2009 Pall Corporation

Executive:  Robert Passas, Ph.D., President, EMEA & APAC Regions

Joined Chembio:  2016

Previous Experience: 2015-2016, VP, Worldwide Marketing and International Sales at Trinity Biotech; 1993-2015  The Binding Site, Abbott, Trinity Biotech, Quidel

Executive:  Thomas Ippolito, VP Regulatory & Clinical Affairs

Joined Chembio: 2005

Previous Experience: 2000-2005, VP Quality & Regulatory of Biospecific Technologies Corp.; 1984-2000 United Biomedical Inc., Analytab Products Inc. and Eastern Long Island Hospital

Executive:  Paul Lambotte, Ph.D, VP Product Development

Joined Chembio: 2014

Previous Experience: 2009 – 2014, President of PLC Inc.; 2009 – 2012 Chief Science Officer of Axxin Pty Ltd.; 2000-2009, VP of R&D and Business Development of Quidel, Inc.

Executive:  David Gyorke, VP Manufacturing Operations

Joined Chembio: 2017

Previous Experience: 2011-2016, VP operations of Nanomix, 1983-2011, NeoVista, Farallon Medical, Inc., Cholestech Corporation, Bio-Rad