Form 8-K CHEMBIO DIAGNOSTICS, For: May 07

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 7, 2015 (May 7, 2015)

CHEMBIO DIAGNOSTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

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))

 

 

 

 

 

 

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On May 7, 2015, the Company issued a press release entitled "Chembio Diagnostics Reports First Quarter 2015 Financial Results".   A copy of the press release is furnished herewith as Exhibit 99.1.

On May 7, 2015, the Company posted a PowerPoint Presentation to their website entitled "Investor Presentation May 2015."  A copy of the presentation is furnished herewith as Exhibit 99.2.

In addition, also on May 7, 2015, the Company posted an Investor Fact Sheet to their website.  A copy of the fact sheet is furnished herewith as Exhibit 99.3

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.

Exhibits.

 

 

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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.

By:    /s/ John J. Sperzel III                                      

John J. Sperzel III

Chief Executive Officer

 

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EXHIBIT INDEX

Chembio Diagnostics Reports First Quarter 2015 Financial Results

Conference Call and Webcast Today at 10:00 a.m. Eastern Time

MEDFORD, NY, May 7, 2014 -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leader in point-of-care diagnostic tests for infectious diseases, today reported financial results for the three months ended March 31, 2015.

John J. Sperzel III, Chembio's Chief Executive Officer, stated, "In the first quarter, we achieved multiple important growth metrics.  During the period our total revenue was $6.23 million, an increase of 7.2% as compared to Q1 2014.  Product revenue for Q1 2015 was $5.61 million, an increase of 14.5% as compared to Q1 2014.  One of the most important measures for the Company is DPP^® revenue which was $2.46 million during Q1 2015, an increase of 110.7% compared to Q1 2014.  We are also pleased to report an increase in product gross margin from 27.8% in the first quarter of 2014 to 36.9% for the first quarter of 2015."

Mr. Sperzel continued, "Contributing to our sales growth is the fact that Chembio's product portfolio is the strongest it's ever been. Today, we have 100% control of our DPP^® products and STAT-PAK^® products on a worldwide basis.  Also, as announced in January 2015, we finalized an agreement to regain full rights related to the SURE CHECK^® HIV 1/2 Assay, including sales, marketing, distribution, manufacturing and trademark rights, which will become effective June 1, 2016. The DPP^®, STAT-PAK^® and SURE CHECK^® HIV Assays are all approved by the U.S. Food and Drug Administration (FDA) and CLIA-waived for the detection of antibodies to HIV 1 and HIV 2.  Most important, our assays are recognized as high quality products and some of the most important tools in the fight against HIV and other infectious diseases.  Just recently, the AIDS Institute / New York State Department of Health added DPP^® HIV 1/2 Assay to the list of CLIA-waived HIV rapid tests that are approved for funding, making it the only oral fluid HIV rapid test on the list.  We are proud to have the respect of the healthcare community and it is our goal to preserve and strengthen this reputation in the U.S. and around the world.

"Although, as discussed below, our net loss of $647,000 represents an increase in net loss of $422,000 in Q1 2015 over Q1 2014, a large portion of this increase is attributable to increased R&D, and sales and marketing, expenses that we believe will inure to Chembio's benefit in the future.

"Our decisions and execution in 2014 paved the way to new partners, new products and new markets.  During the first quarter of 2015 we observed significant, and in some cases, tremendous growth in total revenue, product revenue, DPP^® revenue and product gross margins.  Our collaboration programs, as well as our internal development programs are advancing – each moving a step closer to adding value to the Chembio pipeline. The first quarter of 2015 provided a strong signal validating our strategy, commercialization organization, products, team and, most importantly, our capabilities.  More so than ever, we believe we are on the path to brand expansion and global growth."

Financial information comparing the 2015 first quarter to the 2014 first quarter:

•	Total revenues of $6.23 million, compared with $5.81 million (an increase of 7.2%).

•	Product sales of $5.61 million, compared with $4.90 million (an increase of 14.5%).

•	Operating loss of $875,000, compared with operating loss of $383,000

•	Net loss of $647,000, or $0.07 per diluted share, compared with net loss of $225,000, or $0.02 per diluted share

Additional First Quarter 2015 Information

Total revenues for the first quarter of 2015 of $6.23 million were up 7.2% compared with total revenues of $5.81 million in the prior-year period. Product sales in the 2015 first quarter of $5.61 million were up 14.5% compared with product sales of $4.90 million in the prior-year period.  R&D milestone, and grant and royalty revenues for the three months ended March 31, 2015 decreased to $616,000 from $909,000 in the prior-year period.

Gross margin dollars for the 2015 first quarter increased 18% to $2.69 million compared with $2.27 million for the prior-year period, due primarily to the increase in product sales. The amount of product gross margin for the first quarter of 2015 increased 51.8% to $2.07 million, from $1.36 million in the prior-year period.

R&D expenses in the first quarter of 2015 were $1.58 million, compared with $1.20 million in the prior-year period. This increase is due primarily to increased R&D activities for projects and grants.

Selling, general and administrative expenses in the first quarter of 2015 increased to $1.98 million from $1.48 million in the prior-year period, largely due to increased commissions on DPP® sales, wages and related costs and increased travel expenses.

Operating loss for the first quarter of 2015 was $875,000, compared with an operating loss of $383,000 for the prior-year period.

Net loss for the first quarter of 2015 was $647,000, or $0.07 per diluted share, compared with net loss of $225,000, or $0.02 per diluted share, for the prior-year period.

Balance Sheet Highlights

The Company had cash and cash equivalents of $2.82 million as of March 31, 2015, compared with $4.61 million as of December 31, 2014. The decrease was primarily due to net cash used in operating activities of $.94 million as well as investing activities to fund the purchase of a license and deposits on and purchase of fixed assets of $.86 million. Our working capital decreased by $1.05 million during the three months from $12.37 million to $11.32 million.

Conference Call

To participate on the conference call on May 7, 2015 at 10:00 a.m. Eastern Time, please dial (877) 407-0778 from the U.S. or (201) 689-8565 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until May 14, 2015 at 11:59 p.m. Eastern Time by dialing (877) 660-6853 from the U.S. or (201) 612-7415 from outside the U.S. and entering conference ID #:13608374. Those interested in listening to the conference call live via the internet may do so by visiting the Investor Relations section of Chembio's website at www.chembio.com. The conference call may also be accessed via the internet at http://www.investorcalendar.com/IC/CEPage.asp?ID=173970. An archive of the webcast will be available for 90 days on the Company's website at www.chembio.com.

About Chembio Diagnostics

Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $8.0 billion point-of-care testing market. Chembio markets its DPP^® HIV 1/2 Assay and HIV 1/2 STAT-PAK® Assay in the U.S. and internationally. The Company's SURE CHECK^® HIV 1/2 Assay is marketed exclusively in the U.S. as Clearview^® Complete by a single entity. Outside the U.S., Chembio markets its SURE CHECK^® HIV 1/2 Assay primarily through distributors.

Chembio has developed a patented point-of-care (POC) test platform technology, the Dual Path Platform (DPP^®) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products.

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. Chembio Diagnostic Systems, Inc. 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)

Contacts:

Chembio Diagnostics

Susan Norcott

(631) 924-1135, ext. 125

Vida Strategic Partners (investor relations)

Stephanie C. Diaz

(415) 675-7401

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Investor Presentation May 2015

NASDAQ:CEMI

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

Our Vision & Mission

We enable longer and healthier living through detection and monitoring of serious diseases.

Our mission is to be a leader in the development and commercialization of diagnostic solutions. We are dedicated to delivering high-quality products that provide ease of use, and rapid and accurate results at the point-of-care (POC). As a global company, we are committed to innovation and the highest quality standards.

Slide 4

Investment Highlights

•	Global Provider of High Quality POC Infectious Disease Tests

‐	Sales in 43 countries

•	Revenue Growth Averaged 15% Over Last Five Years

‐	From $13.83 MM for FY 2009; to $27.65MM for FY 2014

•	Patented DPP® (Dual Path Platform®) Technology

‐	Lead Product: DPP® Blood/Oral Fluid HIV 1/2 Assay (FDA-Approved & CLIA-Waived)

‐	DPP® Revenue Growth of 137% in 2014 as compared to 2013

•	Future Pipeline of DPP® POC Assays

‐	HIV-Syphilis Combination Assay (US version)

‐	HIV Ab/Ag Assay

‐	Hepatitis C (HCV) Assay

•	New Collaborations and Development Projects

‐	POC DPP® Assays for Malaria, Dengue Fever, Ebola, Febrile Illness, Flu Immunostatus, Brain Injury and a Specific Type of Cancer

Slide 5

Global POC Diagnostics Company

U.S.

•	Revenue (FY '14):  $7.2MM or 28%

•	Established U.S. Sales & Marketing (June '14)

•	DPP® HIV 1/2 FDA Approved, CLIA-Waived

•	Funded Research: CDC, DOD, NIH (2013)

EUROPE

•	Achieved CE mark for SURE-CHECK® HIV (July '13)

•	Achieved CE mark for HIV STAT-PAK®, (March '14)

•	Pending CE mark for DPP® HIV and DPP® HIV/Syphilis Assays

ASIA

•	Established License, Technical Transfer, Contract Manufacturing, Distribution  Agreement (Feb. '14)

LATIN AMERICA

•	Revenue (FY '14): $16.4MM or 63%

•	Strong OEM Partnerships (e.g., FIOCRUZ, Labtest)

•	Branded products sold to NGOs, private  distributors

MERA (Middle East, Russia, Africa)

•	Revenue (FY '14): $2.1MM or 8%

•	Sales channel: NGO-direct & through distributors

•	Procurements primarily funded by PEPFAR, Global Fund, and WHO

Slide 6

POC In-Vitro Diagnostics (IVD) Total Global Market

Professional POC Market ($ million)

* Source: Kalorama Worldwide Market for IVD Tests - July 2012

(1) Historical        (2) Projected

Slide 7

Chembio Market Opportunities

HIV Market

•	35 million people were living with HIV/AIDS worldwide (2012)

•	1.6 million people died of AIDS-related illnesses (2012)

•	In total, ~75 million people have been infected with the HIV virus and ~36 million have died of HIV

HIV Prevalence (15-49 years), by WHO Region  (See graphics)

Syphilis Market

•	Approx. 12 million people globally become ill with syphilis annually

•	From 2005-2013, syphilis cases in the U.S. nearly doubled, from 8,724 to 16,663

•	Syphilis in pregnancy leads to ~305,000 fetal & neonatal deaths annually

New Cases of STIs, by WHO Region

(See graphics)  Source: World Health Organization (2012)

Slide 8

HIV In The U.S. - The Importance of Testing

•	More than 1.1 million people in the United States are living with HIV infection, and almost 1 in 6 of them (15.8%) are unaware of their infection

•	There are ~50,000 new infections per year in the U.S.

•	For every HIV infection that is prevented, an estimated $355,000 is saved in the cost of providing lifetime HIV treatment

Source: Center for Disease Control & Prevention (CDC)

Slide 9

Chembio "Lateral Flow" POC Tests

·	Two Lateral Flow POC HIV Tests

‐	Chembio HIV 1/2  STAT-PAK®

‐	Chembio SURE CHECK® HIV 1/2 ¹

•	Key Product Features

‐	FDA (PMA)-Approved, CLIA-Waived

‐	Sensitivity: 99%

‐	CE Marked, WHO Approved

•	Lateral flow patent expired in February 2015

‐	Chembio's royalty payments for lateral flow technology ended Feb 2015

¹ Sold in U.S. as Clearview Complete® HIV 1/2

See graphics

Slide 10

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

·	Patented technology

·	Allows improved sensitivity and specificity compared to lateral flow technology

·	Enables multiple test results via a single blood sample (e.g., HIV-Syphilis Combo Assay)

·	Offers application within infectious disease and potential for a number of other indications

See graphics

Slide 11

DPP® Assays – Commercial Products

DPP® HIV 1/2 Assay

•	U.S. FDA (PMA) approved, CLIA-Waived  for use with blood and oral f luid samples

•	U.S. Launch- Q4 2014

•	Entering the ~$35MM oral fluid Assay market

•	Superior Performance (sensitivity) vs. competitors

•	Patented SampleTainer®Sample Collection System

DPP HIV-Syphilis Combo Assay

•	First to market with POC HIV-Syphilis combo assay

•	First HIV-Syphilis Assay to be USAID Approved

•	First to receive ANVISA approval (Brazil)

•	Successfully launched in Mexico

•	Global screening opportunities:

‐	Pregnant Women (Incidence 1.9MM)1

‐	MSM (up to 70% HIV-Syphilis co-infection)2

¹World Health Organization (WHO);   ²Center for Disease Control & Prevention (CDC)

Slide 12

DPP® Internal Development Pipeline

·	DPP® HIV-Syphilis Assay (U.S. market)

o	Next Generation DPP® HIV-Syphilis "Combo" Assay for detection of HIV and Syphilis Antibodies

·	DPP® HCV Assay

o	Next Generation DPP® HCV Assay for the detection of Hepatitis C Antibody

·	DPP® HIV Ab/Ag Assay

o	Next Generation DPP® HIV for the detection of HIV Antibody and Antigen

·	DPP® HIV 1/2 Oral Fluid Assay Enhancements

o	Next Generation DPP® HIV 1/2 Assay for the enhanced detection of antibodies in oral fluid

Slide 13

DPP® Research Collaborations

·	DPP® Malaria (Multiplex Assay)

o	Bill & Melinda Gates Foundation

·	DPP® Dengue Fever (Multiplex Assay)

o	Undisclosed Partner

·	DPP® Ebola and Febrile Illness (Multiple Assay)

o	Intergrated BioTherapeutics, Inc.

·	DPP® Flu Immunostatus Assay (Multiplex Assay)

o	Centers for Disease Control & Prevention (CDC) Contractor

·	DPP® Traumatic Brain Injury (Multiplex Assay)

o	Perseus Science Group, LLC

·	DPP® Cancer (Specific Form) Assay

o	Undisclosed Partner

Slide 14

•	Bio-Rad Laboratories, Inc. (NYSE: BIO)

‐	DPP® Technology Used for Bio-Rad Geenius™ HIV 1/2 Confirmatory Assay

•	Oswaldo Cruz Foundation (Brazil)

‐	Five DPP® Products Currently Being Sold to NGO's and Private Distributors

•	Centers for Disease Control & Prevention (CDC)

‐	Research Collaboration Agreement: DPP® Ebola and DPP® Febrile Illness

•	LabTest (Brazil)

‐	Assembly, Distribution – DPP® Co-branded (2015 Product Registration)

•	RVR (Malaysia)

‐	License, Technical Transfer, Contract Manufacturing, Distribution

•

Other

‐	Additional opportunities in discussion/development

Slide 15

Chembio Manufacturing Capabilities

•	Leased facilities (~60,000 sq. ft.) in Medford and Holbrook, NY

•	High Volume Manufacturing Capabilities (>15MM tests annually)

•	Robust Quality Management System

‐	POC tests serve diverse, regulated market

‐	Audited routinely by FDA CDRH/CBER, WHO, USDA, ISO (LNE), and our collaborators

‐	Expertise in manufacturing scale up, process validation and cGMP

              Approximately 162 total employees

Slide 16

Selected Financial Data FY2009 –2013

2014

Total Revenue $27,645

Product Revenue$ 25,950

Gross Profit $10,814

R&D Expense* $4,748

Clinical Trial Expense $206

Income before taxes $1,285

R&D Exp. & 2010 Pre-Tax Income

See graphics

Slide 17

Selected Financial Highlights

Note: Accounts receivable as of 3/31/14 was $3,370 compared to 3/31/15 of $8,260

Slide 18

2014 Milestones - Achieved

•	Product Development/Regulatory

‐	Achieved CE Mark for HIV 1/2 STAT-PAK®: March 2014

‐	Received CLIA Waiver for DPP® HIV 1/2 CLIA: October 2014

‐	Entered development agreements for Dengue Fever and specific Cancer assay: Oct 2014

‐	Signed Agreement with CDC Contractor to Develop POC Influenza Immunity: Nov 2014

Corporate/Operations

‐	Finalized Agreement with RVR (Malaysia) to build position in Asia: Feb 2014

‐	Established U.S. Distribution/Warehouse facility in Holbrook, NY: May 2014

‐	Obtained Exclusive POC license for certain IBT Ebola reagents: October 2014

‐	Increased Manufacturing Footprint and Capacity in Medford, NY: Dec. 2014

Commercial / Sales & Marketing

‐	Terminated STAT-PAK® Distribution Agreement with U.S. Distributor: June 2014

‐	Established Chembio U.S. Sales & Marketing team ( DPP® HIV 1/2 , HIV 1/2 STAT-PAK®): June 2014

‐	Signed DPP® and STAT-PAK agreements with 3 leading U.S. distributors: Sept-Oct 2014

Slide 19

2015 Milestones- Achieved & Anticipated

•	Product Development/Regulatory

‐	Entered into Agreement with Perseus to Develop DPP® Brain Injury Assay:  January 2015

‐	Grant from Bill & Melinda Gates Foundation to Develop DPP® Malaria: January 2015

‐	Achieved ANVISA Approval for DPP® HIV-Syphilis Assay in Brazil:  February 2015

‐	Provide DPP Malaria-Ebola Assay to CDC for Field Testing in West Africa

‐	Initiate Clinical Trial for DPP HIV-Syphilis Assay (U.S.)

•	Corporate/Operations

‐	Hired Paul Lambotte Ph.D. (VP, Product Development): December 2014

•	Commercial / Sales & Marketing

‐	Acquired Full Rights to SURE CHECK® HIV 1/2 Assay, effective June 1, 2016:  January 2015

‐	Expand Chembio U.S. Commercialization Team

‐	Enter into Additional Distribution Agreements in the U.S. Market

‐	Launch DPP® HIV-Syphilis Assay in Brazil

Slide 20

Executive Leadership Team

Executive:  John J. Sperzel III,   President &CEO

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

Joined:  2014

Executive:  Richard Larkin, CPA  Chief Financial Officer

Previous Experience: 2000-2003  CFO of Visual Technology Group; 1987-2000 CFO of Protex  International Corp.

Joined:  2003

Executive:  Sharon Klugewicz, M.S.  Chief Operating Officer

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

Joined:  2012

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

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

Joined:  2000

Executive:  Thomas Ippolito, VP Regulatory & Clinical Affairs

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

Joined:  2005

Executive:  Michael Steele, VP Sales, Marketing and Business Development

Previous Experience: 2008-2011, VP Business Development of SeraCare Life Sciences; 1992-2008 Corautus Genetics, Life Therapeutics and Serologicals, Inc.

Joined:  2012

Executive:  Paul Lambotte, Ph.D

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

Joined: 2014

Slide 21

Investment Highlights

•	Global Provider of High Quality POC Infectious Disease Tests

‐	Sales in 43 countries

•	Revenue Growth Averaged 15% Over Last Five Years

‐	From $13.83MM for FY 2009; to $27.65MM  for FY 2014

•	Patented DPP® (Dual Path Platform) Technology

‐	Lead Product: DPP® Blood/Oral Fluid HIV 1/2 Assay (FDA-Approved, CLIA-Waived)

‐	DPP® Revenue Growth of 137% in 2014 as compared to 2013

•	Future Pipeline of DPP® POC Assays

‐	HIV-Syphilis Combination Assay (US version)

‐	HIV Ab/Ag Assay

‐	Hepatitis C (HCV) Assay

•	New Collaborations and Development Projects

‐	POC DPP® Assays for Malaria, Dengue Fever, Ebola, Febrile Illness, Flu Immunostatus, Brain Injury and a Specific Type of Cancer

 

Corporate Fact Sheet

May 2015

Ticker:      CEMI

Exchange:    Nasdaq

Share Price:    $4.70/share

Market Cap:    $45.25 Million

 

 

o	Sales in 43 countries

·	Revenue Growth Averaged 15% per Year Over Last Five Years

o	$13.83MM for FY 2009, $27.65MM for FY 2014

·	Patented DPP® (Dual Path Platform) Technology

o	Lead Product: DPP® HIV 1/2  Assay for Blood/Oral Fluid

o	FDA Approved & CLIA-Waived

o	DPP® Revenue Growth of 137% in 2014 as compared to 2013

·	Future Pipeline of DPP® POC Assays

o	HIV-Syphilis Combination Assay (U.S.)

o	HIV Antibody/Antigen Assays

o	HCV Antibody Assay

o	HIV 1/2  Assay - Oral Fluid Enhancements

·	New Collaborations and Development Projects for:

o

Malaria

o	Dengue Fever

o

Ebola

o	Febrile Illness

o	Flu Immunostatus

o	Brain Injury

o	Cancer (specific form)

 

 

Chembio Diagnostics Inc. (NASDAQ: CEMI) develops, manufactures licenses and markets rapid diagnostic assays in the growing $8.0 billion point-of-care (POC) testing market.  In addition to its branded and proprietary HIV assays, which it sells in the U.S. and internationally, the Company has seven ongoing collaborations for the development of diagnostic assays for malaria, dengue fever, Ebola and other febrile illness, flu immunostatus, brain injury, and a specific form of cancer.

Dual Path Platform (DPP®) is Chembio's patented point of care technology, which offers significant advantages over lateral flow technologies including enhanced sensitivity and the ability to conduct multiple tests from a single sample (multiplexing).   DPP® continues to provide Chembio with a strong pipeline of business opportunities for the development and manufacture of new products.

CHEMBIO'S LEAD PRODUCTS

o	Rapid, multiplex detection of HIV 1, HIV 2 and syphilis using a single sample

DPP® HIV 1/2 Assay

o	Rapid detection of HIV 1 and HIV 2 antibodies in oral fluid and all blood matrices

HIV 1/2 STAT-PAK® Assay

o	Single-use, rapid, visual detection of HIV 1 and HIV 2 antibodies

SURE CHECK® HIV 1/2 Assay

o	Self-contained, single-use collection & testing device

(See graphics)

PAGE 2

o	Patented technology

o	Allows improved sensitivity and specificity compared to lateral flow technology

o	Enables multiple test results via a single blood sample (e.g., HIV-Syphilis Combo Assay)

o	Offers application within infectious disease and potential for a number of other indications

(See graphics)

o	35 million people living with HIV/AIDS worldwide (2013)

o	More than 1.1 million people in the U.S. are living with HIV infection, and almost 1 in 6 (15.8%) are unaware of their infection

o	There are ~50,000 new infections per year in the U.S.

o	For every HIV infection that is prevented, an estimated $355,000 is saved in the cost of providing lifetime HIV treatment.

o	Approx. 12 million people globally become ill with syphilis annually

o	From 2005-2013, syphilis cases in the U.S. nearly doubled, from 8,724 to 16,663

o	Syphilis in pregnancy leads to ~305,000 fetal and neonatal deaths annually

o	DPP® HIV-Syphilis Assay (U.S. market)

o	DPP® HCV Assay

o	DPP® HIV Ab/Ag Assay

o	DPP® HIV 1/2 Oral Fluid Assay Enhancements

o	DPP® Malaria – The Bill & Melinda Gates Foundation

o	DPP® Dengue Fever – Undisclosed partner

o	DPP® Ebola & Febrile Illness- Integrated Bio Therapeutics, Inc.

o	DPP® Flu Immunostatus- CDC Contractor

o	DPP® Traumatic Brain Injury- Perseus Science Group LLC

o	DPP® Cancer (a specific form) – Undisclosed collaborator

o	DPP® technology for Geenius™ HIV 1/2 Confirmatory Assay – Bio Rad

o	Distribution of 5 DPP® products in Brazil- Oswaldo Cruz Foundation

o	Research Agreement: DPP® Ebola and DPP® Febrile Illness - CDC

o	DPP® co-branding and distribution in Brazil- Labtest, Diagnostica SA

o	DPP® tech transfer, manufacture and distribution in Malaysia- RVR

 

 

John J. Sperzel III, Chief Executive Officer

Richard Larkin, CPA, Chief Financial Officer

Sharon Klugewicz, M.S., Chief Operating Officer

Javan Esfandiari, M.S., Chief Science & Technology Officer

 

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