Corporate Presentation

Transcription

1 Corporate Presentation January Chembio. All Rights Reserved. # 2019 Chembio. All Rights Reserved. Page 1

2 Safe Harbor Statement 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, Chembio's ability to integrate and operate optricon GmbH in accordance with Chembio's business strategy, 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 Chembio. All Rights Reserved. Page 2

3 Investment Highlights Proprietary DPP technology platform with broad diagnostic applications, best in class sensitivity and specificity, and advanced multiplex capabilities Growing point-of-care infectious disease business (42.7% (1) growth for the first nine months 2018 vs. first nine months 2017) with multiple product pipeline opportunities Expansion into new diagnostic markets via technology collaborations that leverage DPP platform (cancer, concussion/brain injury, veterinary, companion) Operational initiatives underway to automate U.S. manufacturing to add capacity, reduce variable costs and drive margin expansion Commercialization strategy to broaden sales channels, further penetrating existing markets and expanding into new territories (1) Based on unaudited total revenue 2019 Chembio. All Rights Reserved. Page 3

4 Who We Are Chembio Diagnostics is a leading point-of-care diagnostics company focused on detecting and diagnosing infectious diseases, while building additional revenue streams by leveraging our patented DPP technology through collaborations Chembio. All Rights Reserved. Page 4

5 Patented DPP Technology Platform Offers uniqueness and broad global market application Product Features Simple - easy to use Fast - results in ~15 minutes Reliable - FDA Approved, CLIA Waived Product Uniqueness Enhanced sensitivity and specificity Advanced multiplexing capabilities Quantitative results - with DPP Micro Reader 99.8% Sensitivity (1) 100% Specificity (1) (1) Based on fingerstick whole blood samples: DPP HIV 1/2 Assay 2019 Chembio. All Rights Reserved. Page 5

6 Acquired optricon GmbH Strengthens our strategic position in the global point-of-care testing market About optricon GmbH Based in Berlin, Germany OEM developer/manufacturer of hand-held analyzers for quantitative interpretation of rapid diagnostic tests Purchase Price: $5.5M Why Buy optricon? Science & Technology Park Berlin, Germany Secure global commercial rights in all markets and materially reduce product cost, enabling Chembio to aggressively promote DPP tests and DPP Micro Readers DPP Micro Reader is included in most of our new product development initiatives and numerous regulatory approvals/submissions DPP Micro Reader optrilyzer Analyzer 2019 Chembio. All Rights Reserved. Page 6

7 2017 Lateral Flow Test Market: $5.5B (1) Expected to grow at 8.2% CAGR (1), reaching $8.2B (1) (2022) Significant growth drivers are: high prevalence of infectious diseases worldwide, increase in geriatric population, growing demand for rapid test results, and multiplexing advancements The lateral flow market includes: infectious disease, cardiac markers, cholesterol/lipids, pregnancy/fertility, and drugs of abuse. Infectious disease is the largest and fastest growing segment, estimated at $1.4 billion (2) annually and growing at ~10% CAGR (2) Chembio is currently pursuing three areas within the infectious disease market: Sexually Transmitted Disease tests Mosquito-borne Disease tests Hepatitis tests Influenza tests Tuberculosis tests (1) MarketsandMarkets. (2) Management estimates Chembio. All Rights Reserved. Page 7

8 Corporate Priorities Executing on our key building blocks to drive growth and operating efficiency Expand Our core point-of-care infectious disease business Leverage Our patented DPP technology and scientific expertise Broaden Our sales and marketing channels worldwide Automate Our U.S. manufacturing operations and increase capacity 2019 Chembio. All Rights Reserved. Page 8

9 Point-of-Care Infectious Disease Products Multiple commercial products serving unique customer requirements Key Advantages Small sample size μL fingerstick blood sample Rapid results ~15 minute test time Reliable performance Sensitive and Specific Advanced multiplexing* HIV-Syphilis Syphilis Screen & Confirm Product U.S. Int l (1) DPP HIV 1/2 DPP HIV-Syphilis* DPP Syphilis S&C* DPP Zika DPP Leishmania STAT-PAK HIV 1/2 STAT-PAK Chagas SURE CHECK HIV 1/2 SURE CHECK HIV Self Test (1) International markets require specific country registrations 2019 Chembio. All Rights Reserved. Page 9

10 Growth Opportunities in Infectious Disease Multiple organic growth drivers are moving the business Registrations of existing and new products into unchartered countries - Latin America - Southeast Asia Increased market penetration in existing markets and channels - United States - Brazil - Africa - Europe Entry into new market segments - HIV Self-Testing (International) Advancing our POC infectious disease product pipeline - Sexually Transmitted Disease - Fever & Tropical Disease Lateral flow infectious disease market forecasted to grow at ~10% CAGR (1) ( ) (1) Management estimates Chembio. All Rights Reserved. Page 10

11 Sexually Transmitted Disease Market HIV and Syphilis affect >50 million people globally HIV/AIDS continues to be a major global public health issue, claiming more than 35 million lives to date, including 940,000 in 2017 (1) Approximately 36.9 million people were living with HIV at the end of 2017, the same year 1.8 million people became newly infected (1) There are an estimated 18 million prevalent cases of syphilis and 5.6 million new infections occur annually (2) Global Prevalence HIV: 36.9M Syphilis: 18.0M (1) (2) WHO guidelines for the treatment of syphilis Chembio. All Rights Reserved. Page 11

12 HIV-Syphilis Co-infection is a Global Concern Eliminating mother-to-child transmission is a global health priority Key Accomplishments Developed DPP HIV-Syphilis multiplex test Received regulatory approvals from ANVISA (Brazil), COFEPRIS (Mexico), CE mark (EU) Completed DPP HIV-Syphilis U.S. clinical trial Filed FDA Pre-Market Approval (PMA) Application Next Steps After receipt of FDA approval, launch to U.S. moderately complex sites Submit CLIA Waiver application After receipt of CLIA Waiver, launch to U.S. CLIA Waived sites Continue to pursue international registrations In 2013, the World Health Organization (WHO) reported that 1.9 million pregnant women were infected with syphilis worldwide, of which 66.5% had adverse fetal effects in cases of untreated syphilis. Congenital syphilis contributes significantly to infant mortality, accounting for 305,000 perinatal deaths worldwide annually. (1) More than 1.4 million pregnant women are infected with HIV, and mother-to-child transmission (MTCT) of HIV is estimated to have resulted in over 150,000 infant cases in (2) (1) ncbi.nlm.nih.gov/pmc/articles/pmc (2) ncbi.nlm.nih.gov/pmc/articles/pmc / Chembio. All Rights Reserved. Page 12

13 Tropical and Fever Disease Overview Established markets and channels present significant opportunity Chembio Pursuing Established Markets Malaria (216M cases, 446K deaths) (1) Dengue (390M cases, 3.9B at risk) (2) Annual Cases Dengue: 390M Malaria: 216M Chembio Pursuing Emerging Markets Zika Chikungunya Ebola Lassa Marburg Leptospirosis Burkholderia Rickettsia (1) who.int/news-room/fact-sheets/detail/malaria. (2) who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue 2019 Chembio. All Rights Reserved. Page 13

14 Chembio's Infectious Disease Pipeline Significant support and funding from collaborators: $9.4M (Q1 15 Q3 18) Product Name Collaborator Phase I (Feasibility) Phase II (Development) Phase III (Verification/Validation) Phase IV (Clinical/Regulatory) Phase V (Commercial Launch) DPP HIV-Syphilis (US) DPP Dengue (Int l) Self-funded Submitted FDAPMA Q SubmittedANVISA Q DPP Dengue NS1 (Int l) Ongoing DPP Zika (US/Int l) DPP Chikungunya (Int l) DPP Dengue-Zika-Chikungunya (Int l) SubmittedANVISA Q Received: FDAEUA, ANVISA, CE mark Received: ANVISA, Malaysia Received: Malaysia DPP Malaria (Int l) Ongoing DPP Ebola (US, Int l) Ongoing Received: FDAEUA DPP Fever Panel (Africa) Field Testing:Africa, South America DPP Fever Panel (Asia) Ongoing 2019 Chembio. All Rights Reserved. Page 14

15 Leverage our Technology via Collaborations Why are global leaders choosing Chembio to solve their challenges? Deep scientific expertise with a proven technology platform Sensitive and specific Advanced multiplexing capabilities Quantitative results Successful track record developing DPP tests with diverse collaborators Global commercial companies Governments Non-governmental organizations Extensive experience achieving global regulatory approvals U.S. FDA, WHO PQ, CE mark, ANVISA, COFEPRIS 2019 Chembio. All Rights Reserved. Page 15

16 Chembio s Ongoing Technology Collaborations Collaborations provide fully-funded R&D costs and growth potential Product Name Collaborator Phase I (Feasibility) Phase II (Development) Phase III (Verification/Validation) Phase IV (Clinical/Regulatory) Phase V (Commercial Launch) DPP Undisclosed Biomarker Ongoing Submitted CE mark DPP Cancer Undisclosed Ongoing Infectious Disease Portfolio Initiatedfeasibility Q DPP Concussion Perseus Science Ongoing DPP Bovine Tuberculosis Ongoing DPP Hepatitis C Ab Ongoing DPP Hepatitis C Ag Initiatedfeasibility Q Chembio. All Rights Reserved. Page 16

17 Leverage our DPP Technology Platform What opportunities do our technology collaborations provide? Expansion into new markets Cancer Diagnostics Concussion / Traumatic Brain Injury Veterinary Broadening application from POC diagnostics to companion diagnostics Drugs Vaccines Cost-effective research & development, fully funded by collaborators 2019 Chembio. All Rights Reserved. Page 17

18 Automate and Expand U.S. Manufacturing Automated DPP line delivered June 18 and commencing production Q4 18 Efficient Reduces variable costs to produce DPP tests Intelligent Enhances inspection and quality control via vision-guided, robotic operation Flexible Allows assembly of various configurations of DPP tests on a single line Scalable Expands capacity by 5-10 million tests with each new line Chembio s fully-automated DPP assembly & packaging line 2019 Chembio. All Rights Reserved. Page 18

19 Financial Results Significant revenue growth on annual and year-to-date (YTD) basis Revenue (millions) Annual Revenues +34% YTD Revenues (1) +43% $24.0 $25.8 $17.9 $ YTD Q YTD Q3 (1) YTD revenue figures are unaudited Chembio. All Rights Reserved. Page 19

20 2019 Chembio. All Rights Reserved. Page 20