Form 8-K CHEMBIO DIAGNOSTICS, For: Mar 03

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 5, 2015 (March 5, 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))

 

 

 

 

 

 

---

 

 

 

 

 

 

---

On March 5, 2015, the Company issued a press release entitled "Chembio Diagnostics Reports 2014 Financial Results".   A copy of the press release is furnished herewith as Exhibit 99.1.

On March 5, 2015, the Company posted a PowerPoint Presentation to their website entitled "Investor Presentation March 2015."  A copy of the presentation is furnished herewith as Exhibit 99.2.

In addition, also on March 5, 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.

 

 

 

 

 

---

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

 

 

---

EXHIBIT INDEX

 

 

 

 

Chembio Diagnostics Reports 2014 Financial Results

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

MEDFORD, NY, March 5, 2014 -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leader in point-of-care diagnostic tests for infectious diseases, today reported financial results for the year ended December 31, 2014.

John J. Sperzel III, Chembio's Chief Executive Officer, stated, "We are pleased to report Q4 revenues of $7.10 million and year-end revenues of $27.65 million.  This marks the third consecutive quarter in which we have had revenues above the $7.0 million mark and we are thrilled that our DPP^® sales for the year increased by 137% as compared to 2013.   While total revenues for 2014 represent a slight decrease as compared to 2013, this is due primarily to Chembio's fulfillment of a single $5.3 million STAT-PAK^® order in 2013, which did not recur in 2014, as well as a decrease in U.S. sales revenue of $2.3 million due to our termination of the STAT-PAK^® distribution agreement with Alere.  Despite the approximately $7.6 million attributable to these two factors, Chembio was able to report only a $1.9 million decline in revenue for the year.  This was made possible by the dramatic growth we are seeing in DPP^® product sales, which accounted for 60% of 2014 sales compared to 24% of sales in the prior year."

Mr. Sperzel continued, "It is Chembio's goal to combine our history and expertise in HIV diagnostics with our innovative DPP^® technology to create a global diagnostic business that extends well beyond HIV and infectious disease.  To this end, the strategy that we implemented in 2014 has already begun to pay dividends.  Last year we established and expanded our U.S. sales and marketing team, met multiple regulatory milestones including the CLIA-waiver for our DPP^® HIV 1/2 Assay for use with oral fluid and blood, generated significant sales growth in Latin America, advanced our partnership in Malaysia, and established new high-potential partnerships to develop new and innovative diagnostics for Dengue fever, Ebola and febrile illness, flu immunostatus and a specific form of cancer."

 

"Our partnering momentum has continued into 2015 as we've recently entered into an agreement to develop a point-of-care (POC) test for traumatic brain injury (including sports related concussion) and we have partnered with the Bill & Melinda Gates Foundation toward the development of a next-generation POC Malaria assay.  With these achievements behind us, we are optimistic that the strategy we implemented in 2014 will strengthen our base business in POC infectious disease testing, create new opportunities to leverage our patented DPP^® technology, advance our key development programs and commercial partnerships, and establish the foundation for success in 2015 and beyond."

 

Financial information comparing Q4 and the full-year 2014 are to the 2013 periods (Note: 2013 included the shipment of a single $5.3 million international STAT-PAK^® order, which did not recur in 2014 as well as a $2.3 million decline in sales to Alere following termination of our STAT-PAK^® distribution agreement).

Financial information comparing the full year 2014 to the full year 2013:

•	Total revenues of $27.65 million compared with $29.55 million (a decrease of 6.4%);

•	DPP® revenues of $15.66 million compared with $6.59 million (an increase of 137%)

•	Operating loss of $1,550,000, compared with operating income of $1,005,000;

•	Net loss of $1,137,000, or $0.12 per diluted share, compared with net income of $531,000, or $0.06 per diluted share.

Financial information comparing the 2014 fourth quarter to the 2013 fourth quarter:

•	Total revenues of $7.10 million, compared with $7.86 million (a decrease of 9.7%).

•	Product sales of $6.55 million, compared with $7.10 million (a decrease of 7.7%).

•	Operating loss of $672,000, compared with operating loss of $176,000

•	Net loss of $496,000, or $0.05 per diluted share, compared with net loss of $262,000, or $0.03 per diluted share

Additional 2014 Information

The total revenues for the year 2014 consisted of product sales of $25.95 million compared with $27.52 million for the prior-year.  R&D, milestone, and grant and royalty revenues for 2014 were $1,696,000 compared with $2,034,000 for the prior-year. The decrease in product sales is due primarily to the shipment in 2013 of $5.30 million from a single non-recurred STAT-PAK^® order, as well as the decline in sales in Africa and to Alere in 2014, the latter as a result of the termination of our STAT-PAK^® distribution agreement, partially offset by increased DPP® sales.  However, during 2014, total aggregate end-user sales of our STAT-PAK^® and SURE CHECK^® lateral flow products in the U.S. increased over 2013.

Gross margin for the year 2014 was $10.81 million compared with $12.30 million for the prior-year, due primarily to the non-recurrence of the STAT-PAK^® order described above and also to product mix. Product gross margin for the year 2014 was $9.12 million compared with $10.27 million for the prior-year, also due primarily to the non-recurrence of the STAT-PAK^® order, product mix, and the decline in STAT-PAK^® sales to Alere.

R&D expenses for the year 2014 were $4.83 million compared with $5.83 million for the prior-year. This decrease is due primarily to a reduction in clinical trial expense related to our DPP^® HIV 1/2 Assay CLIA waiver study.

Selling, general and administrative expenses for the year 2014 were $7.53 million compared with $5.46 million for the prior-year, largely due to higher investment in sales and marketing personnel, increased commissions, and related costs.

Operating loss for the year 2014 was $1,550,000 compared with operating income of $1,005,000 for the prior-year.  

Net loss for the year 2014 was $1,137,000, or $0.12 per diluted share, compared with net income of $531,000, or $0.06 per diluted share, for the prior-year. 

Fourth Quarter Information

Total revenues for the fourth quarter of 2014 of $7.10 million were down 9.7% compared with total revenues of $7.86 million in the prior-year period. Product sales in the 2014 fourth quarter of $6.55 million were down 7.7% compared with product sales of $7.10 million in the prior-year period.  R&D milestone, and grant and royalty revenues for the three months ended December 31, 2014 decreased to $546,000 from $764,000 in the prior-year period.

Gross margin for the 2014 fourth quarter decreased 11% to $2.91 million compared with $3.27 million for the prior-year period, due primarily to the lower amount of R&D, milestone, and grant and royalty revenues. The amount of product gross margin for the fourth quarter of 2014 decreased 5.7% to $2.36 million, from $2.50 million in the prior-year period.

R&D expenses in the fourth quarter of 2014 were $1.39 million, compared with $1.69 million in the prior-year period. This decrease is due primarily to a reduction in clinical trial expense related to our DPP® HIV 1/2 Assay CLIA waiver study.

Selling, general and administrative expenses in the fourth quarter of 2014 increased to $2.19 million from $1.76 million in the prior-year period, largely due to increased wages and related costs and increased marketing materials.

Operating loss for the fourth quarter of 2014 was $672,000, compared with an operating loss of $176,000 for the prior-year period.

Net loss for the fourth quarter of 2014 was $496,000, or $0.05 per diluted share, compared with net loss of $262,000, or $0.03 per diluted share, for the prior-year period.

 

 

Balance Sheet Highlights

The Company had cash and cash equivalents of $4.61 million as of December 31, 2014, compared with $9.65 million as of December 31, 2013. The decrease was primarily due to net cash used in investing activities to fund deposits on and purchase of fixed assets of $1.45 million as well as net cash used in operating activities of $3.82 million, which included an increase in accounts receivable of $3.77  million, an increase in inventory of $.45 million and an increase in accounts payable of $.64 million. Our working capital decreased by $1.85 million during the year from $14.22 million to $12.37 million.

Conference Call

To participate on the conference call, please dial (877) 407-0778 from the U.S. or (201) 689-8565 from outside the U.S.  Following the completion of the call, a telephone replay will be accessible until March 12, 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 #:13602180.  Those interested in listening to the conference call live via the internet may do so by visiting teh 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=173680.  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 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.

 

Contacts:

Chembio Diagnostics

Susan Norcott

(631) 924-1135, ext. 125

Vida Strategic Partners (investor relations)

Stephanie C. Diaz

(415) 675-7401

 

 

 

 

 

(Tables to follow)

---

 

 

---

    

   

Investor Presentation March 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

 

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

Slide 7

Current Market Opportunities

HIV Market

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

•	1.6 million people died of AIDS-related illnesses in 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 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 fluid 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® 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 HIV 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 (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

 

 

DPP® Technology Collaborations

•	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 partners

‐	Expertise in manufacturing scale up, process validation and cGMP

              Approximately 162 employees

Slide 16

Selected Financial Data FY2010 –2014

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

See graphics

Slide 17

Selected Financial Highlights

Slide 18

2014 Milestones - Achieved

•	Product Development/Regulatory

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

‐	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

 

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 $16.70MM for FY 2010; 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

March 2015

Ticker:            CEMI

Exchange:        Nasdaq

Share Price:      $4.09/share

Market Cap:      $39.4 Million

·	Global Provider of High Quality POC Infectious Disease Assays

o	Sales in 43 countries

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

o	$16.70MM for FY 2010, $27.65MM for FY 2014

·	Patented DPP® (Dual Path Platform) Technology

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

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 Oral Fluid Assay Enhancements

·	High Value Partnerships 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 our branded and proprietary HIV assays, which it sells in the U.S. and internationally, the Company has six ongoing collaborations for the development of diagnostic assays for malaria, dengue fever, Ebola and 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® is providing Chembio with a growing pipeline of business opportunities for the development and manufacture of new 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	35.2 million people living with HIV/AIDS worldwide (2012)

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 partner

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

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