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): November 10, 2016 (November 10, 2016)
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
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(Commission File Number)
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(IRS Employer
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of Incorporation)
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Identification Number)
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3661 Horseblock Road
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Medford, NY 11763
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(Address of principal executive offices)
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631-924-1135
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(Registrant's Telephone Number)
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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 November 10, 2016, the Company issued a press release entitled "Chembio Diagnostics Reports Third Quarter 2016 Financial Results". A copy of the press release is furnished herewith as Exhibit 99.1
On November 10, 2016, the Company posted a PowerPoint Presentation to their website entitled "Investor Presentation November, 2016." A copy of the presentation is furnished herewith as Exhibit 99.2.
In addition, also on November 10, 2016, 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.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS
Exhibit Number
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Description
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99.1
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Press Release entitled "Chembio Diagnostics Reports Third Quarter 2016 Financial Results" dated November 10, 2016
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99.2
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Presentation entitled "Investor Presentation November, 2016" dated November 10, 2016
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99.3
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Investor Fact Sheet posted to the company website dated November 10, 2016
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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.
November 10, 2016 Chembio Diagnostics, Inc.
By: /s/ John J. Sperzel II
I
John J. Sperzel III
Chief Executive Officer
EXHIBIT INDEX
Exhibit Number
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Description
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99.1
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Press Release entitled "Chembio Diagnostics Reports Third Quarter 2016 Financial Results" dated November 10, 2016
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99.2
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Presentation entitled "Investor Presentation November, 2016" dated November 10, 2016
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99.3
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Investor Fact Sheet posted to the company website dated November 10, 2016
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Exhibit 99.1
Chembio Diagnostics Reports Third Quarter 2016 Financial Results
Conference Call and Webcast Today at 10:00 a.m. Eastern Time
MEDFORD, NY, November 10, 2016 -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care ("POC") diagnostic tests for infectious diseases, today reported financial results for the three and nine months ended September 30, 2016.
John J. Sperzel III, Chief Executive Officer, stated, "The Company made important advances in multiple areas during the third quarter of 2016, intended to prepare the Company for growth: commercialization, regulatory approvals, product development grants, and equity financing. With respect to Chembio's commercial infrastructure, the Company appointed two seasoned executives to build our worldwide sales and marketing capabilities, with immediate focus on the United States, Latin America, Asia Pacific and Africa. The Company expanded its distribution network by appointing Isla Lab, the largest distributor of diagnostic products in the Caribbean, as its exclusive distributor in that region.
"Chembio recently secured two important regulatory approvals. In July 2016, the Company obtained a CE mark for the DPP® Zika IgM/IgG Assay and DPP® Micro Reader, allowing the products to be marketed and sold in 17 European countries, including the United Kingdom, Germany, and France, as well as a majority of the Caribbean nations. In late October 2016, the Company received approval by Brazil's health regulatory agency, Agência Nacional de Vigilância Sanitária (ANVISA) for DPP® Zika IgM/IgG Assay. These regulatory achievements follow the milestone which occurred at the end of the second quarter of 2016, when Chembio's DPP® HIV 1/2 Assay was accepted for the World Health Organization (WHO) list of prequalified in vitro diagnostics.
"In August 2016, Chembio completed an equity financing which provided gross proceeds of approximately $13.8 million, which provides the Company with capital needed to advance its product development programs and invest in the sales and operational infrastructure needed to support sustained growth. Also in August 2016, Chembio was awarded a contract for up to $13.2 million in total funding from the U.S. Department of Health and Human Services (HHS); Office of the Assistant Secretary for Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA) to develop and commercialize the Company's DPP® Zika IgM/IgG Assay and Zika-related products.
"Subsequent to the 2016 third–quarter end, Chembio entered into an agreement to acquire RVR Diagnostics Sdn Bhd (RVR), a Malaysian, privately-held manufacturer and distributor of POC diagnostic tests for infectious diseases. Subject to satisfaction of conditions to closing, completion of the RVR acquisition will provide the Company with a strategically located and cost-effective manufacturing facility, an additional revenue source, and the potential to accelerate important product registrations in Southeast Asia, which we believe will be important in serving a number of global markets."
Addressing the company's financial results, Mr. Sperzel commented, "Despite reporting a decrease in product sales for both the second and third quarters of 2016, a quarter-over-quarter analysis shows sales growth with total revenues for the third quarter of 2016 up 15% and product sales for the third quarter of 2016 up 23%, as compared to the second quarter of 2016. In the United States, sales of the HIV 1/2 STAT-PAK® Assay increased 44% as compared to the third quarter of 2015, and increased 21% as compared to the second quarter of 2016. This growth provides strong evidence that we are effectively rebuilding the U.S. HIV STAT-PAK® business, since we took back the U.S. distribution rights to this product in June 2014. We are also seeing encouraging U.S. sales of the HIV 1/2 SURE CHECK® Assay since we took back distribution rights to this product at the end of May 2016. Through the Company's achievements in strengthening commercial infrastructure, securing regulatory approvals, improving its balance sheet, obtaining a multi-million dollar grant from the U.S. Government, and establishing operations in the growing Asian market, we believe Chembio is on a path to establish a global operation with potential for growth in several important markets."
Selected Summary Financial Information comparing the 2016 third quarter to the 2015 third quarter:
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Total revenues of $3.75 million, compared with $6.89 million.
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Product sales of $2.50 million, compared with $6.21 million.
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Operating loss of $2.14 million, compared with operating loss of $579,000.
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Net loss of $2.14 million, or $0.19 per diluted share, compared with net loss of $437,000, or $0.05 per diluted share.
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Selected Summary Financial Information comparing the first nine months of 2016 to the first nine months of 2015:
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Total revenues of $13.61 million, compared with $19.83 million.
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Product sales of $10.45 million, compared with $18.15 million.
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Operating loss of $5.00 million, compared with operating loss of $2.35 million.
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Net loss of $10.79 million, or $1.06 per diluted share, compared with net loss of $1.75 million, or $0.18 per diluted share.
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Additional Financial Information
Third Quarter:
Total revenues in the 2016 third quarter of $3.75 million decreased 45.6% compared with $6.89 million in the prior-year period. Product sales in the 2016 third quarter of $2.50 million decreased 59.7% compared with $6.21 million in the prior-year period. R&D milestone, and grant and royalty revenues in the 2016 third quarter of $1,244,000 increased 83.4% compared with $678,000 in the prior-year period.
Gross margin dollars in the 2016 third quarter of $1.95 million decreased 32.9% compared with $2.91 million in the prior-year period, due primarily to decreased product revenues. Product gross margin dollars in the 2016 third quarter of $0.71 million decreased 68.3% compared with $2.23 million in the prior-year period, which also was primarily due to the decreased product revenues.
R&D expenses in the 2016 third quarter of $2.26 million increased 44.2%, compared with $1.57 million in the prior-year period. This increase is due primarily to increased clinical trial expenses as well as R&D activities for projects and grants.
Selling, general and administrative expenses in the 2016 third quarter of $1.83 million decreased 4.5% compared with $1.92 million in the prior-year period, largely due to decreased commissions, which were due to decreased sales in Brazil, as well as decreases in stock-based compensation, travel, entertainment and trade shows, consulting, and other expenses, which were partially offset by increases in wages and related costs, marketing materials, professional fees and investor relations expenses.
Operating loss in the 2016 third quarter was $2,144,000, compared with an operating loss of $579,000 in the prior-year period.
Net loss in the 2016 third quarter was $2,138,000, or $0.19 per diluted share, compared with net loss of $437,000, or $0.05 per diluted share, in the prior-year period.
First Nine Months:
Total revenues in the 2016 first nine months of $13.61 million decreased 31.4% compared with $19.83 million in the prior-year period. Product sales in the 2016 first nine months of $10.45 million decreased 42.4% compared with $18.15 million in the prior-year period. R&D milestone, and grant and royalty revenues in the 2016 first nine months of $3,161,000 increased 87.2% compared with $1,689,000 in the prior-year period.
Gross margin dollars in the 2016 first nine months of $6.70 million decreased 22.3% compared with $8.62 million in the prior-year period, due primarily to the decrease in product sales. The amount of product gross margin in the 2016 first nine months of $3.54 million decreased 48.9% compared with $6.93 million in the prior-year period.
R&D expenses in the 2016 first nine months of $6.27 million increased 27.6%, compared with $4.91 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 2016 first nine months of $5.43 million decreased 10.3%, compared with $6.06 million in the prior-year period, largely due to decreased commissions on sales in Brazil, decreased wages and related costs, stock-based compensation, consulting and travel, entertainment and trade shows, which were partially offset by increases in marketing materials, investor relations expenses and professional fees.
Operating loss in the 2016 first nine months was $4,998,000, compared with an operating loss of $2,352,000 in the prior-year period.
Net loss in the 2016 first nine months was $10,789,000, or $1.06 per diluted share, compared with net loss of $1,748,000, or $0.18 per diluted share, in the prior-year period. The net loss in the 2016 period includes a tax provision for the recording of a valuation allowance on the Company's deferred tax asset of $5,801,000.
Valuation Allowance
The Company elected, based on accounting guidance, to record a full Valuation Allowance ("VA") on its Deferred Tax Asset ("DTA"). Chembio's DTA was primarily based on the Company's Net Operating Loss (NOL) carryforwards. Based primarily on the fact that the Company believes, given information available to it at this time, that it is more likely than not that the deferred tax asset will not be realized in the foreseeable future, the Company concluded that it was appropriate to record a full VA against its DTA. This resulted in a tax provision in the second quarter of 2016 of $5.96 million and for the nine months ended September 30, 2016 of $5.80 million. This VA does not affect the Company's ability to use its NOLs in the future.
Balance Sheet Highlights:
The Company had cash and cash equivalents of $12.17 million as of September 30, 2016, compared with $5.38 million as of December 31, 2015. The increase was primarily due to net cash raised in the sale of common stock, partially offset by cash used in operating activities for the nine months of 2016. Our working capital increased by $8.06 million from $9.48 million as of December 31, 2015 to $17.54 million.
In early August 2016, the Company sold 2,300,000 common shares for a total of $13.8 million, which after expenses resulted in approximately $12.5 million in net funds to the Company.
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. In addition, following the completion of the call, a telephone replay will be accessible until November 17, 2016 at 11:59 p.m. ET by dialing (877) 481-4010 from the U.S. or (919) 882-2331 from outside the U.S. and entering conference ID: 10129. The conference call may also be accessed via the internet at http://www.investorcalendar.com/IC/CEPage.asp?ID=175428. An archive of the webcast will be available for 90 days on the Company's website at www.chembio.com.
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. To listen to the live call, please go to the website 15 minutes prior to its start to register, download, and install the necessary audio software. A replay will be available on the website for a limited time.
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 each of its DPP® HIV 1/2 Assay, HIV 1/2 STAT-PAK® Assay, and SURE CHECK® HIV 1/2 Assay, with these Chembio brand names, in the U.S. and internationally both directly and through third-party distributors. The Company's SURE CHECK® HIV 1/2 Assay previously has been exclusively sold in the U.S. as Clearview® Complete HIV 1/2 Assay.
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
snorcott@chembio.com
Vida Strategic Partners (investor relations)
Stephanie C. Diaz
(415) 675-7401
sdiaz@vidasp.com
Investor Presentation November 10, 2016
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
Investment Highlights
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A global leader in point-of-care (POC) infectious disease
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Sales in 40+ countries, including United States
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Core business in POC HIV testing; 8% annual revenue growth (2010-2015)
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Groundbreaking patented DPP® technology platform
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Superior sensitivity and specificity vs lateral flow technology
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Multiple tests from a tiny (10uL) drop of blood from the fingertip (multiplexing)
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Robust pipeline of new DPP® POC assays in development
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DPP® HIV-Syphilis Combination Assay (U.S. version)
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DPP® Fever Assays (Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg)
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DPP® Technology Collaborations (Traumatic Brain Injury, Cancer, Bovine TB)
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Multiple high-value collaborations
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U.S. Government, HHS/ASPR/BARDA: Zika, Dengue, Chikungunya
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Paul G. Allen Ebola Program: Fever Panel, Zika
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Bill & Melinda Gates Foundation: Malaria Oral Fluid/Saliva
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Centers for Disease Control & Prevention (CDC): Malaria, Ebola
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Experienced leadership team
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Slide 4
Chembio's Dual Path Platform (DPP®) Technology
Next-Generation Point-of-Care Technology Platform
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Patented POC technology platform
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Improved sensitivity vs. lateral flow technology
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Multiplex capability - multiple test results from a single patient sample
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Adapts to multiple sample types (blood, oral fluid)
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Application across a range of diseases and markets
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Unique sample collection device: Sampletainer®
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See graphics
Slide 5
Chembio's Dual Path Platform (DPP®) Technology
Leveraging Our Technology Platform to Enter New Markets
Three areas of Strategic Focus:
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Technology Collaborations
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DPP® Technology Platform
Slide 6
HIV Continues to be a Global Health Crisis Syphilis
HIV-Syphilis Co-Infection are Increasing
United States (HIV)
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~ 1.2 million living with HIV/AIDS
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~ 50,000 new HIV infections/year
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1 in 8 unaware of HIV infection
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United States (SYP)
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~63,000 new infections (2014)
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Global (HIV)
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36.7 million living with HIV/AIDS (2015)
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1.1 million died of AIDS-related illnesses (2015)
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Global (SYP)
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12 million new infections/year
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"Over the past decade, the number of people living with HIV has increased, while the annual number of new HIV infections has remained relatively stable." -CDC
"An estimated two million pregnancies are affected annually; approximately 25% of these pregnancies end in stillbirth or spontaneous abortion, and in a further 25% the newborn has a low birth rate or serious infection, both of which are associated with an increased risk of perinatal death" -WHO
Source: Centers for Disease Control & Prevention (CDC) website; World Health Organization (WHO) website
Slide 7
Chembio Lateral Flow HIV Tests
Foundational HIV Product Suite
Product Features & Benefits
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FDA (PMA) approved, CLIA-waived
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CE marked, WHO pre-qualified
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2.5 - 5.0 μL blood sample
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15 - 20 minute test time
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Specificity: 99.9%, Sensitivity: 99.7%
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Commercialization
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High quality brands, marketed globally since 2007
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Sold to Public Health Clinics, POLs, Hospitals, Self Test (EU)
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Distribution Partners (US): Fisher, McKesson/PSS, H. Schein, Medline, Caribbean: Isla Lab
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See graphics
Slide 8
Chembio DPP® HIV and DPP® HIV-SYP Combo Tests
Strengthening our HIV/STD Portfolio
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DPP® HIV-Syphilis Combo Assay
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Chembio has a history of leadership
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First to receive USAID, ANVISA, Cofepris approval
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First to market/sell in Latin America
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Global screening opportunity:
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MSM (up to 70% HIV-Syphilis co-infection)
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Initiated US clinical trials for FDA approval and CLIA Waiver (Q1, 2016)
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FDA-approved (2013), CLIA-waived (2014)
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(blood and oral fluid)
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Superior performance vs. competitors
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(sensitivity)
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Patented SampleTainer® Sample Collection System
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See graphics
Slide 9
Chembio's Dual Path Platform (DPP®) Technology
Leveraging Our Technology Platform to Enter New Markets
Three areas of Strategic Focus:
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Technology Collaborations
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DPP® Technology Platform
Slide 10
Fever Disease – Product Development
Chembio is Collaborating with World Leading Organizations
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Bill & Melinda Gates foundation
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CDC - Center for Disease Control
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The Paul G. Allen Family Foundation
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See graphics
Slide 11
DPP® Fever Disease- Product Development
Fever Panel, Ebola, Malaria, Malaria-Ebola
DPP® Fever Panel, Collaborator: The Paul G. Allen Foundation
DPP® Malaria OF/Saliva Assay: Collaborator: The Bill & Melinda Gates Foundation
DPP® Malaria-Ebola Assay: Collaborator: CDC
DPP® Ebola Assay: Collaborator: CDC
DPP® Zika Assay: Collaborators: HHS/BARDA & The Paul G. Allen Foundation
DPP® Zika/Dengue/Chik Assay: Collaborator: HHS/BARDA
DPP® Dengue Assay: Collaborator: RVR Diagnostics
DPP® Chikungunya Assay: Chembio Internal Development
Slide 12
Fever Diseases - A Growing Global Concern
Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg
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Mosquito-Borne Illnesses
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Mosquito à world's deadliest animal
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Responsible for 725,000 deaths/year
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Global geographic coverage
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Established Fever Markets:
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Malaria: > 200 million annual infections
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Dengue: ~300 million annual infections
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Emerging Fever Markets:
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What Crisis Will We Face Next?
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See graphics
Slide 13
Zika Virus
Why is Zika a Concern and Why is Chembio Well-Positioned?
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Local Zika Transmission
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2015 (Brazil) à 2016 (~60 countries)
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Travelers to/from Endemic Areas
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Molecular Tests Limitations
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Convenience: lab test, venous sample
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Detects acute infections
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Chembio Zika Test Advantage
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Convenience: POC Test; fingerstick sample
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Time to Result: 15 minutes
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Detects Antibodies (lgM/lgG)
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Source: Centers for Disease Control & Prevention (CDC) website
See graphics
Slide 14
DPP® Zika/Dengue/Chikungunya - Development
Zika Virus represents the latest global health crisis
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Accelerated DPP® Zika Assay Development
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Received grant from Paul G. Allen Foundation and initiated project – 2/16
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Announced Zika collaboration with Bio-Manguinhos/Fiocruz (Brazil) – 3/16
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Completed testing of >1,000 samples (including 600 pregnant women) – 4/16
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Announced regulatory filings with FDA-EUA (US, PR), ANVISA (Brazil) – 5/16
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Announced regulatory filings with WHO-EUA, Cofepris (Mexico), CE mark – 7/16
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Announced U.S. Government (HHS/BARDA) funding of up to $13.2 million – 8/16
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Received approval for commercial use from ANVISA in Brazil – 9/16
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Development of Zika-related DPP® Assays
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Continued development of DPP® Dengue IgM/IgG Assay
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Initiated development of DPP® Chikungunya IgM/IgG Assay
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Initiated development of DPP® Zika/Chikungunya/Dengue IgM/IgG Combo Assay
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See graphics
Slide 15
Chembio's Dual Path Platform (DPP®) Technology
Leveraging Our Technology Platform to Enter New Markets
Three areas of Strategic Focus:
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Technology Collaborations
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DPP® Technology Platform
Slide 16
Technology Collaborations:
Bio-Rad(NYSE:BIO) and opTricon (Berlin, Germany)
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Bio-Rad Geenius™ System: HIV-1 and HIV-2 Confirmation
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Marketed/sold by Bio-Rad (ex-Brazil)
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Chembio DPP® Micro Reader: Quantitative Results & Data Mgmt.
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Improves DPP ® Performance
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Provides quantitative results
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Standardizes result interpretation
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Data capture, storage, transmission
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Key features: Simple, palm-sized, easy-to-read, battery-operated, cost-effective
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See graphics
Slide 17
Chembio's Dual Path Platform (DPP®) Technology
Leveraging Our Technology Platform to Enter New Markets
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Biomarkers to Detect Specific Form of Cancer
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10uL Blood Sample, 20 Minute Test
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DPP® TBI/Concussion Assay
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Perseus Science Group, LLC
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Biomarker to Detect TBI/Concussion
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10uL Blood Sample, 20 Minute Test
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See graphics
Slide 18
Manufacturing Capabilities
United States (Chembio)
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High volume manufacturing capabilities
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Current capacity: 20MM+ tests annually
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60,000 sq. ft. leased facilities
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Medford, NY and Holbrook, NY
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Robust quality management system
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Full compliance with regulatory requirements (FDA, USDA, WHO, ISO)
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Expertise in manufacturing scale up, process validation and cGMP
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Number of employees: ~140
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Malaysia (RVR)
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Completed license and technology transfer
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Completed contract manufacturing readiness
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Received initial regulatory approval for distribution of Chembio's products into Malaysia
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Initiated plan to manufacture certain Chembio-branded products
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Chembio signed agreement on 11/4/16 to acquire RVR subject to closing conditions
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Slide 19
Selected Financial Highlights
Nine Months Ended (in 000's)
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Sept. 30, 2016
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Sept. 30, 2015
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Net Product Revenues
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$
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10,453
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$
|
18,146
|
|
Total Revenues
|
|
$
|
13,614
|
|
|
$
|
19,835
|
|
Gross Margin
|
|
$
|
6,698
|
|
|
$
|
8,616
|
|
Loss from Operations
|
|
$
|
(4,998
|
)
|
|
$
|
(2,352
|
)
|
Net Loss
|
|
$
|
(10,789
|
)*
|
|
$
|
(1,748
|
)
|
Cash (as of end of period)
|
|
$
|
12,172
|
**
|
|
$
|
1,102
|
|
* The net loss in the 2016 period includes a tax provision for the recording of a valuation allowance on the Company's deferred tax asset of $5,801,000.
**Company public offering of securities, closed August 3, 2016, resulted, after expenses, in an additional approximately $12.5MM in net funds to the company.
Slide 20
Experienced Executive Leadership Team
Executive: John J. Sperzel III, President &CEO
Joined Chembio: 2014
Previous Experience: 2011-2013, President and CEO of ITC.; 1987-2011 Axis-Shield, Bayer Diagnostics, Instrumentation Laboratory and Boehringer Mannheim
Executive: Richard Larkin, CPA Chief Financial Officer
Joined Chembio: 2003
Previous Experience: 2000-2003 CFO of Visual Technology Group; 1987-2000 CFO of Protex International Corp.
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; 2011-2015 Commercial Director at The Binding Site; 1993-2011 Abbott, Trinity Biotech, Quidel
Executive: Javan Esfandiari, M.S. Chief Science and Technology Officer
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: 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: Michael Steele, VP Sales, Marketing and Business Development
Joined Chembio: 2012
Previous Experience: 2008-2011, VP Business Development of SeraCare Life Sciences; 1992-2008 Corautus Genetics, Life Therapeutics and Serologicals, Inc.
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.
Corporate Fact Sheet
November 2016
STOCK INFORMATION (as of November 7, 2016)
Ticker: CEMI
Exchange: Nasdaq
Share Price: $7.00/share
Market Cap: $83.90 Million
CORPORATE HIGHLIGHTS
• Global Provider of High Quality POC Infectious Disease Assays
• Sales in 43 countries
• Patented DPP® (Dual Path Platform) Technology
• Multiple products sold into Latin America and U.S.
·
|
Lead Product: DPP® HIV 1/2 Assay for Blood/Oral Fluid
|
·
|
FDA Approved & CLIA-Waived
|
Future Pipeline of DPP® POC Assays (currently in internal development)
•HIV-Syphilis Combination Assay (U.S.)
• Malaria Assay
• Ongoing Collaborations and Development Projects for:
·
|
Malaria (oral fluid/saliva)
|
COMPANY SNAPSHOT
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 several ongoing collaborations for the development of diagnostic assays for Malaria, Dengue, Zika, Ebola and othr febrile illness, flu immunostatus, brain injury and a specific form of cancer.
Dual Path Platform (DPP®) is Chembio's patented POC 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 growing pipeline of business opportunities for the development and manufacture of new products.
CHEMBIO'S LEAD PRODUCTS
DPP® HIV-Syphilis Assay *available in selected non-U.S. markets
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
CHEMBIO'S DPP® DUAL PATH PLATFORM
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
|
Utilized with DPP® Micro Reader for improved results
|
o
|
Offers application within infectious disease and potential for a number of other indications
|
(See graphics)
Sexually Transmitted Diseases
HIV
o
|
Approximately 37 million people living with HIV/AIDS worldwide (2015)
|
o
|
More than 1.1 million people in the U.S. are living with HIV infection, and approximately 1 in 8 are unaware of their infection
|
SYPHILIS
o
|
Approx. 12 million people globally become ill with syphilis annually (2015)
|
o
|
From 2005-2013, syphilis cases in the U.S. nearly doubled, from 8,724 to 16,663
|
Fever Diseases
Malaria
·
|
Approximately 214 million infections and 438,000 deaths annually (2015)
|
Dengue Fever
·
|
Approximately 100 million infections annually with 40% of the world population at risk (2013)
|
Ebola
·
|
Approximately 28,000 infections and 11,000 deaths in 2014 – 2015
|
Zika
·
|
In February 2016, WHO declared the Zika virus a "public health emergency of international concern," as the virus spread to more than twenty countries.
|
DPP PIPELINE & COLLABOTATORS
Chembio Current Internal Development:
o
|
DPP® HIV-Syphilis Assay (U.S. market)
|
Current Development Collaborations
• DPP® Dengue Fever – Undisclosed collaborator
• DPP® Ebola & Febrile Illness – CDC Research Agreement
·
|
DPP® Fever Panel – The Paul G. Allen Ebola Program
|
·
|
DPP® Malaria OF/Saliva– The Bill and Melina Gates Foundation
|
·
|
DPP® Zika Assay – The Paul G. Allen Family Foundation
|
·
|
DPP® Zika/Dengue/Chikungunya Assay-HHS/BARDA (option)
|
·
|
DPP® Traumatic Brain Injury – Perseus Science Group LLC
|
• DPP® Cancer (a specific form) – Undisclosed collaborator
• Bovid TB Assay- U.S. Department of Agriculture
Tech transfer and Distribution
o
|
DPP® technology for Geenius™ HIV 1/2 Confirmatory Assay – Bio Rad
|
o
|
DPP® product distribution 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
|
SENIOR EXECUTIVE OFFICERS
John J. Sperzel III, Chief Executive Officer
Javan Esfandiari, M.S., Chief Science & Technology Officer
Richard Larkin, CPA, Chief Financial Officer
Sharon Klugewicz, M.S., President, America's Region
Robert Passas, Ph.D, President, EMEA & APAC Regions
Chembio Diagnostics, Inc.
|
Investor Relations
|
Company Contact
|
3661 Horseblock Road
|
Vida Strategic Partners
|
Susan Norcott
|
Medford, NY 11763
|
Stephanie C. Diaz
|
631-924-1135 x125
|
Ph. 631-924-1135
|
(415) 675-7401
|
snorcott@chembio.com
|
Fax 631-924-2065
|
sdiaz@vidasp.com
|
|
www.chembio.com
|
|
|
This regulatory filing also includes additional resources:
investorpresentation.pdf
factsheet.pdf
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