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 9, 2017 (May 9, 2017)
CHEMBIO DIAGNOSTICS, INC.
(Exact name of registrant as specified in its charter)
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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 May 9, 2017, the Company issued a press release entitled "Chembio Diagnostics Reports First Quarter 2017 Financial Results". A copy of the press release is furnished herewith as Exhibit 99.1
On May 9, 2017, the Company posted a PowerPoint Presentation to their website entitled "Investor Presentation May, 2017." A copy of the presentation is furnished herewith as Exhibit 99.2.
In addition, also on May 9, 2017, 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
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Exhibit Number
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Description
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99.1
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Press Release entitled "Chembio Diagnostics Reports First Quarter 2017 Financial Results" dated May 9, 2017
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99.2
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Presentation entitled "Investor Presentation May 2017" dated May 9, 2017
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99.3
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Investor Fact Sheet posted to the company website dated May 9, 2017
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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.
May 9, 2017 Chembio Diagnostics, Inc.
By: /s/ John J. Sperzel III
John J. Sperzel III
Chief Executive Officer
EXHIBIT INDEX
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Exhibit Number
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Description
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99.1
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Press Release entitled "Chembio Diagnostics Reports First Quarter 2017 Financial Results" dated May 9, 2017
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99.2
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Presentation entitled "Investor Presentation May, 2017" dated May 9, 2017
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99.3
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Investor Fact Sheet posted to the company website dated May 9, 2017
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Exhibit 99.1
Chembio Diagnostics Reports First Quarter 2017 Financial Results
Conference Call and Webcast Today at 4:30 p.m. Eastern Time
MEDFORD, NY, May 9, 2017 -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care ("POC") diagnostic tests for infectious diseases, today reported financial results for the quarter ended March 31, 2017.
John J. Sperzel III, Chief Executive Officer, stated, "We are pleased with the early results of the strategy to expand our commercial channels, focusing on the United States (U.S.), Latin America, Asia Pacific, Europe, and Africa. During the fourth quarter of 2016, we made key appointments to strengthen our commercial leadership team, and during the first quarter of 2017 we added experienced diagnostic sales executives in Latin America, Africa and Asia Pacific. With this enhanced organization, we achieved a geographic mix of product sales for the first quarter of 2017, consisting of 39% of sales in Latin America, 26% in Asia Pacific, 20% in the U.S., 8% in Europe, and 7% in Africa.
"During the quarter, the Company continued to expand its product portfolio by leveraging our patented DPP® technology platform, which we believe will result in near-term and long-term growth opportunities. The Company's product development strategy includes two primary objectives: 1) to strengthen our core business in the sexually transmitted disease market, and 2) to build a strong position in the fever and tropical disease market.
"To strengthen our core business in the sexually transmitted disease market, the Company continues to focus on our DPP® HIV-Syphilis Assay in response to the global concerns related to co-infection and mother-to-child transmission of both HIV and Syphilis. During the first quarter of 2017, we received a CE mark for our DPP® HIV-Syphilis Assay, which allows us to market and sell the product within the member states of the European Union and in the Caribbean, except for Puerto Rico. The U.S. clinical trial to support our FDA application for the DPP® HIV-Syphilis Assay, which was initiated during the first quarter of 2016, has been completed. In March 2017, the FDA requested further clinical studies in addition to those recently completed. As a result, Chembio is in discussion with the FDA regarding the timing of filing the Premarket Approval Application. Another important development subsequent to the end of the first quarter of 2017 is that Chembio received a $5.8 million order from Bio-Manguinhos/Fiocruz to supply test components and intermediate product for the production of DPP® HIV 1/2 Assays in Brazil and subsequent supply to Brazil's Ministry of Health. We believe that substantially all of this order will be shipped prior to year-end 2017.
To build a strong position in the fever and tropical disease market, we continue to make significant progress toward the goal of commercializing multiple products during 2017. During the first quarter of 2017, we initiated sales of our DPP® Zika Assay and our DPP® Zika/Dengue/Chikungunya Assay to the Centers for Disease Control and Prevention for use in a pilot surveillance program in Peru, India, Guatemala and Haiti. Also during the 2017 first quarter, we initiated sales of our DPP® Dengue Assay in Asia Pacific, and we continue to pursue important regulatory approvals for our DPP® Zika System with the U.S. FDA Emergency Use Authorization (EUA), World Health Organization Emergency Use Assessment And Listing (EUAL), and Brazil Agência Nacional de Vigilância Sanitária (ANVISA)."
Addressing the Company's financial results, Mr. Sperzel commented, "During the first quarter of 2017, we achieved total revenue of $6.3 million which included product revenue of $5.4 million. While total revenue represented a 4.2% decrease from the first quarter of 2016, it is important to note that the first quarter of 2016 included approximately $1.8 million in product purchases by our previous U.S. distributor, while the first quarter of 2017, included approximately $1.4 million in sales from our recently acquired Malaysia subsidiary. During the first quarter of 2017, we continue to see important quarter-on-quarter sales growth.
"Within a number of geographic regions, we had several notable sales successes during the first quarter of 2017. In Asia Pacific, we achieved $1.4 million in product sales, driven by key tender wins in Malaysia, representing the first time the Company has achieved meaningful sales in Asia. In the U.S., we achieved $1.1 million in product sales, driven by a number of HIV tenders, which were won during the last two quarters, and much of which we expect to realize over the next 18 months. In Latin America, we achieved product sales of $2.1 million driven by sales to Brazil and, as mentioned above, we received a $5.8 million order from Bio-Manguinhos/Fiocruz and we believe that substantially all of this order will be shipped prior to year-end 2017. In Europe and Africa, we achieved $0.8 million in combined product sales, largely driven by HIV sales in the HIV self-testing and professional HIV testing business.
"In closing, we believe the advances made during the first quarter of 2017 demonstrate our commitment to continue building global commercial channels, thereby strengthening our core business in the sexually transmitted disease market, and building a strong position in the high-growth fever and tropical disease market."
Selected Summary Financial Information comparing the 2017 first quarter with the 2016 first quarter:
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Total revenues of $6.3 million, compared with $6.6 million.
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Product sales of $5.4 million, compared with $5.9 million.
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Operating loss of $1.6 million, compared with operating loss of $0.47 million.
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Net loss of $1.6 million, or $0.13 per diluted share, compared with net loss of $.30 million, or $0.03 per diluted share.
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Additional Financial Information
First Quarter:
Total revenues for the first quarter of 2017 of $6.3 million decreased 4.2% compared with $6.6 million in the prior-year period. Product sales for the first quarter of 2017 of $5.4 million decreased 8.3% compared with $5.9 million in the prior-year period, again largely due to the $1.8 million of product purchases in the 2016 period by our former U.S. SURE CHECK® distributor, which did not make any material purchases after March 31, 2016. R&D milestone, and grant and royalty revenues for the first quarter of 2017 of $0.9 million increased 31.2% compared with $0.7 million in the prior-year period.
Gross margin dollars for the first quarter of 2017 of $3.1 million decreased 1.9% compared with $3.2 million in the prior-year period, due primarily to the decrease in product sales. The amount of product gross margin for the first quarter of 2017 of $2.2 million decreased 11.0% compared with $2.5 million in the prior-year period.
R&D expenses for the first quarter of 2017 of $2.2 million increased 37.5%, compared with $1.6 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 for the first quarter of 2017 of $2.5 million increased 24.5%, compared with $2.0 million in the prior-year period, largely due to increased wages and related costs, marketing materials, stock-based compensation, and travel, entertainment and trade shows, which were partially offset by decreased commissions on sales, decreased consulting, and decreases in investor relations expenses and professional fees.
Operating loss for the first quarter of 2017 was $1.6 million, compared with an operating loss of $0.47 million in the prior-year period.
Net loss for the first quarter of 2017 was $1.6 million, or $0.13 per diluted share, compared with net loss of $0.3 million, or $0.03 per diluted share, in the prior-year period.
Balance Sheet Highlights:
The Company had cash and cash equivalents of $5.6 million as of March 31, 2017, compared with $10.6 million as of December 31, 2016. The decrease was primarily due to cash used in operating activities for the first quarter of 2017, as well as cash used in investing activities. The Company's working capital decreased by $2.3 million from $14.7 million as of December 31, 2016 to $12.4 million as of March 31, 2017.
The Company had Accounts Receivable net of allowance for doubtful accounts of $5.7 million as of March 31, 2017, compared with $3.4 million as of December 31, 2016. Cash and Accounts Receivable combined as of March 31, 2017 was $11.3 million as compared to $13.9 million at December 31, 2016. During the months of April and May 2017 we collected $2.8 million of the March 31, 2017 accounts receivable balance.
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.
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. Each of Chembio Diagnostic Systems, Inc. and RVR Diagnostics Sdn Bhd is a wholly-owned subsidiary of Chembio Diagnostics, Inc. For more information, please visit: www.chembio.com.
Forward-Looking Statements
Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements, which are estimates only, reflect management's current views, are based on certain assumptions, and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing and to obtain regulatory approvals in a timely manner, as well as the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.
Contacts:
Company
Susan Norcott
(631) 924-1135 Ext. 125
snorcott@chembio.com
Investor Relations
Vida Strategic Partners (investors)
Stephanie C. Diaz
(415) 675-7401
sdiaz@vidasp.com
(TABLES TO FOLLOW)
Exhibit 99.2
Investor Presentation May 9, 2017
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 & marketing organization in U.S., Europe, Africa, APAC and LATAM
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Manufacturing operations in the U.S. (Medford, NY) and Southeast Asia (Malaysia)
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Groundbreaking patented DPP® technology platform
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Superior sensitivity and specificity vs. traditional lateral flow technology
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Multiple tests from a tiny (10μL) drop of fingertip blood (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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HHS/ASPR/BARDA: Zika (option: Zika/Dengue/Chikungunya);
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CDC: Malaria, Ebola, Zika, Zika/Dengue/Chikungunya
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Paul G. Allen Ebola Program: Fever Panel- Africa, Zika
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Bill & Melinda Gates Foundation: Malaria Oral Fluid/Saliva
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FIND: Fever Panel - Asia
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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
U.S. Syphilis Cases Increase and Risk of HIV-Syphilis Co-Infection
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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“Between 2014 and 2015, the number of reported primary and secondary (P&S) cases in the United States increased by 19%. In the United States, approximately half of men who have sex with men (MSM) with primary and secondary (P&S) syphilis were also living with HIV. In addition, MSM who are HIV-negative and diagnosed with P&S syphilis are more likely to be infected with HIV in the future.”
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-SYP and DPP® HIV 1/2 Assays
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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Received CE mark (Q1 2017)
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Completed U.S. clinical trial for FDA PMA submission and CLIA Waiver application
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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 (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
Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg
DPP® Fever Panel-Africa: Collaborator: The Paul G. Allen Family Foundation (PGAFF)
DPP® Malaria-Ebola Assay: Collaborator: CDC
DPP® Ebola Assay: Collaborator: CDC
DPP® Fever Panel- Asia
DPP® Zika Assay: Collaborators: HHS/BARDA & The Paul G. Allen Family Foundation (PGAFF)
DPP® Zika/Dengue/Chik Assay: Collaborator: HHS/BARDA
DPP® Dengue Assay: Chembio Internal Development
DPP® Chikungunya Assay: Chembio Internal Development
DPP® Malaria OF/Saliva Assay: Collaborator: The Bill & Melinda Gates Foundation
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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Source: Centers for Disease Control & Prevention (CDC) website; World Health Organization (WHO) website
See graphics
Slide 13
Chembio is Well-Positioned to Address Zika Virus
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Local Zika Transmission
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2015 (Brazil) à 2017 (~60 countries)
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Travelers to/from Endemic Areas
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Molecular (MDx) Test Limitations
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Laboratory test, venous sample
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Detects acute infections only - not antibodies
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Chembio Zika Test Advantage
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Convenience: POC Test; fingerstick sample
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Detects Antibodies (lgM/lgG)
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Time to Result: 15 minutes
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Low cost compared to MDX tests
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Source: Centers for Disease Control & Prevention (CDC) website
See graphics
Slide 14
DPP® Zika/Dengue/Chikungunya - Development
Demonstrates Expertise, Efficiency and Dedication
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DPP® Zika IgM/lgG Development/Commercialization Timeline
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Received PGAFF grant; initiated project DPP® Zika Project – 2/16
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Announced Zika collaboration with Bio-Manguinhos/Fiocruz (Brazil) – 3/16
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Completed initial testing; including 600 pregnant women – 4/16
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Announced regulatory filings with FDA-EUA, ANVISA – 5/16
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Announced regulatory filings with WHO-EUA, Cofepris, CE mark – 7/16
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Received CE mark (Europe, Caribbean)- 7/16
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Announced HHS/BARDA funding of up to $13.2 million – 8/16
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Awarded CDC Surveillance Program, DPP® Zika/Dengue/Chikungunya (Peru, India, Guatemala, Haiti)- 9/16
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Received ANVISA approval, DPP® Zika Assay –11/16
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Successful INCQS Evaluation- 2017
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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 Management
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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, 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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U.S. Department of Agriculture (USDA)
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Biomarker to detect bovine tuberculosis
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See graphics
Slide 18
Chembio's Global Commercial Organization
Shift from Product Supply Model to Direct Sales Model
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Regained control of U.S. HIV products (2014 – 2016)
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Terminated prior U.S. distribution agreements (HIV 1/2 STAT-PAK® and SURE CHECK® HIV 1/2)
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Developed internal commercialization structure (2014 – 2016)
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Direct sales of DPP® HIV 1/2, HIV 1/2 STAT-PAK®, and SURE CHECK® HIV 1/2 products in the U.S. market
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Established geographic coverage model in U.S. (2014 – 2016)
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Established agreements with U.S. distributors (e.g., McKesson, H. Schein, Fisher, Medline)
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Hired Experienced and Accomplished Leadership (Q4 2016)
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Robert Passas, Ph.D. – President, EMEA and APAC Regions
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Trinity Biotech; The Binding Site; Abbott, Quidel
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Sharon Klugewicz - President, Americas Region
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Chembio COO; Pall Corporation
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Hired international sales executives to build commercial channels in Latin America, Africa and Asia Pacific (Q4 2016 – Q1 2017)
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Slide 19
Manufacturing Capabilities
Expanding Global Manufacturing and Distribution
Medford, NY Kuala Lampur, Malaysia
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Acquired RVR Diagnostics (January 2017)
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RVR Diagnostics, a subsidiary of Chembio Diagnostics
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International base of operations and existing sales revenue
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Cost effective manufacturing operations, ISO 13485 certification
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Strategic location in Southeast Asia provides access to new markets
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Regulatory access in Southeast Asia market
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Combined Manufacturing Operations
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High volume manufacturing capabilities; current capacity 25MM tests
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65,000 sq. ft. leased facilities (Medford, NY and Malaysia)
|
|
o
|
Robust quality management system (Medford, NY)
|
|
o
|
Full compliance with regulatory requirements (i.e., FDA, USDA, WHO, ISO)
|
|
o
|
Expertise in manufacturing scale up, process validation and cGMP
|
|
o
|
Total number of employees: ~165
|
Slide 20
Selected Financial Highlights
Year Ended (in 000's)
| |
|
March 31, 2017
|
|
|
March 31, 2016
|
|
|
Net Product Revenues
|
|
$
|
5,427
|
|
|
$
|
5,917
|
|
|
Total Revenues
|
|
$
|
6,325
|
|
|
$
|
6,601
|
|
|
Gross Margin
|
|
$
|
3,106
|
|
|
$
|
3,166
|
|
|
Loss from Operations
|
|
$
|
(1,630
|
)
|
|
$
|
(468
|
)
|
|
Net Loss
|
|
$
|
(1,616
|
)
|
|
$
|
(304
|
)
|
|
Accounts Receivable Net
|
|
$
|
5,682
|
|
|
$
|
4,897
|
|
|
Cash (as of end of period)
|
|
$
|
5,582
|
|
|
$
|
2,658
|
|
Experienced Executive Leadership Team
Executive: John J. Sperzel III, President &CEO
Joined Chembio: 2014
Previous Experience: 2011-2013, President and CEO of ITC/Accriva; 1987-2011 Axis-Shield, Bayer Diagnostics, Instrumentation Laboratory and Boehringer Mannheim
Executive: Richard Larkin, CPA Chief Financial Officer; Executive Vice President
Joined Chembio: 2003
Previous Experience: 2000-2003 CFO of Visual Technology Group; 1987-2000 CFO of Protex International Corp.
Executive: Javan Esfandiari, M.S. Chief Science and Technology Officer; Executive Vice President
Joined Chembio: 2000
Previous Experience: 1997-2000, Co-founder of Sinovus Biotech AB (Sweden), acquired by Chembio in 2000; 1993-1997 R&D Director of On-Site Biotech
Executive: Sharon Klugewicz, M.S. President, Americas Region
Joined Chembio: 2012
Previous Experience: 2009-2012, Sr. VP Scientific & Laboratory Services of Pall Corporation; 1991-2009 Pall Corporation
Executive: Robert Passas, Ph.D., President, EMEA & APAC Regions
Joined Chembio: 2016
Previous Experience: 2015-2016, VP, Worldwide Marketing and International Sales at Trinity Biotech; 1993-2015 The Binding Site, Abbott, Trinity Biotech, Quidel
Executive: Thomas Ippolito, VP Regulatory & Clinical Affairs
Joined Chembio: 2005
Previous Experience: 2000-2005, VP Quality & Regulatory of Biospecific Technologies Corp.; 1984-2000 United Biomedical Inc., Analytab Products Inc. and Eastern Long Island Hospital
Executive: Paul Lambotte, Ph.D, VP Product Development
Joined Chembio: 2014
Previous Experience: 2009 – 2014, President of PLC Inc.; 2009 – 2012 Chief Science Officer of Axxin Pty Ltd.; 2000-2009, VP of R&D and Business Development of Quidel, Inc.
Executive: David Gyorke, VP Manufacturing Operations
Joined Chembio: 2017
Previous Experience: 2011-2016, VP operations of Nanomix, 1983-2011, NeoVista, Farallon Medical, Inc., Cholestech Corporation, Bio-Rad
Corporate Fact Sheet
May 2017
STOCK INFORMATION (as of May 8, 2017)
Ticker: CEMI
Exchange: Nasdaq
Share Price: $ 6.70/share
Market Cap: $82.40 Million
CORPORATE HIGHLIGHTS
A global leader in point-of-care (POC) infectious disease diagnostics
|
§
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Global commercialization organization servicing the U.S., Europe, Africa, Asia Pacific and Latin America
|
|
§
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Operations and manufacturing in the U.S. and Southeast Asia
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Groundbreaking patented DPP® technology platform
|
§
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Superior sensitivity and specificity vs. traditional lateral flow technology
|
|
§
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Multiple tests from a tiny (10uL) drop of fingertip blood (multiplexing)
|
Robust pipeline of new DPP® POC assays in development
|
§
|
DPP® HIV-Syphilis Combination Assay (U.S. version)
|
|
§
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DPP® Fever Assays - Africa (Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg)
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§
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DPP® Fever Assay - Asia (Malaria, Dengue, Zika, Chikungunya, Leptospirosis, Rickettsia Typhi, Burkholderia pseudomallei, Orientia tsutsugamushi.)
|
|
§
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DPP® Technology Collaborations (Traumatic Brain Injury, Cancer, Bovine TB)
|
Multiple high-value collaborations
|
§
|
U.S. Government, HHS/ASPR/BARDA: Zika, Dengue, Chikungunya
|
|
§
|
Paul G. Allen Ebola Program: Fever Panel, Africa, 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
|
|
§
|
FIND: Fever Panel - Asia
|
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 Fever, Zika, Ebola and other febrile illness, 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
|
§
|
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)
|
|
§
|
Utilized with DPP® Micro Reader for semi-quantitive results
|
|
§
|
Offers application within infectious disease and potential for a number of other indications
|
(See graphics)
SALES AND MARKETING
|
§
|
Global commercialization organization
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|
§
|
Internal sales and marketing infrastructure
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|
§
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Partnerships with leading distributors
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|
§
|
Experienced and accomplished leadership
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|
§
|
Strategic base of operations in Southeast Asia
|
|
§
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Sales organization servicing the U.S., Europe, Africa, Asia Pacific and Latin America
|
MANUFACTURING AND OPERATIONS
|
§
|
Operations in Medford, New York and Malaysia
|
|
§
|
High volume manufacturing capabilities
|
|
§
|
65,000 sq. ft. leased facilities
|
|
§
|
Robust quality management system
|
|
§
|
Regulatory access in Southeast Asia
|
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
|
Approximately 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 390 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
|
·
|
Since 2015, the geographical range of Zika virus has expanded rapidly, with transmission reported in 60+ countries
|
DPP PIPELINE & COLLABOTATORS
Chembio Current Internal Development:
• DPP® HIV-Syphilis Assay (U.S. market)
• DPP® Malaria Assay
• DPP® Chikungunya Assay
Current Development Collaborations:
• DPP® Dengue Fever – Undisclosed collaborator
• DPP® Ebola & Febrile Illness – CDC Research Agreement
• DPP® Fever Panel – Africa- The Paul G. Allen Ebola Program
• DPP® Fever Panel – Asia - FIND
• DPP® Malaria OF/Saliva– The Bill & Melina Gates Foundation
• DPP® Zika Assay – The Paul G. Allen Family Foundation & HHS/BARDA
• DPP® Zika/Dengue/Chikungunya Assay – HHS/BARDA (option)
• DPP® Traumatic Brain Injury – Perseus Science Group LLC
• DPP® Cancer (a specific form) – Undisclosed collaborator
• DPP® BovidTB Assay – U.S. Department of Agriculture
Tech Transfer and Distribution:
• DPP® technology for Geenius™ HIV 1/2 Confirmatory Assay – Bio Rad
• DPP® product distribution in Brazil – Oswaldo Cruz Foundation
• DPP® co-branding and distribution in Brazil – Labtest Diagnostica SA
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:
factsheet.pdf
investorpresentation.pdf
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