Akers Biosciences, Inc. Reducing the cost of healthcare through faster, easier diagnostics

Transcription

1 Akers Biosciences, Inc. Reducing the cost of healthcare through faster, easier diagnostics 1

2 All statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Akers Biosciences, Inc. (Akers or the Company) products and services, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Forward Looking Statements Any statements that are not historical fact (including, but not limited, to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights and other risks discussed in the Company s registration statement on Form S-1 and other reports filed with the Securities and Exchange Commission which are available for review at Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the Company's business. The Company disclaims any intent or obligation to update these forward-looking statements. 2

3 Reducing the cost of healthcare through faster, easier diagnostics Growing Product Portfolio Five products launched and commercialized Growing Revenues Revenues up 200% over 3 years Growing Global Market Point-of-care diagnostics CAGR of 9.3% through 2018 Robust pipeline will result in eleven products in market by end of 2016 Expanded sales and marketing organization in high growth markets Need for significant healthcare cost savings is driving demand for new point-of-care tests 3

4 In Vitro Diagnostics (IVD) are tests that take place outside of the body Key factors driving IVD market growth: increasing demand for rapid and non-invasive diagnostics availability of more point-of-care tests aging population Akers addresses the large and growing global IVD market Largest IVD Markets USA (47%) Western Europe (31%) The IVD market outpaces pharma industry growth Fastest Growing IVD Market Asia Pacific (CAGR 11.3%) 4

5 Akers has a PROVEN product portfolio of DISRUPTIVE diagnostic solutions Overview delivering customer value Rapid results Replaces more expensive / outsourced lab tests Used in diverse environments Faster diagnosis means faster, more accurate and cost effective medical treatment addressing HIGH NEED MARKETS including Coagulation Diabetes Health and wellness Respiratory diseases Infectious diseases Cardiovascular diseases 5

6 Example of Customer Value There are 4 million tests for Heparin-induced thrombocytopenia every year in the U.S. alone using slower, traditional methods Akers rapid diagnostic tests transform traditional healthcare testing Equipment and Process Time to Results Traditional Testing (ELISA) CapEx required Commonly outsourced PIFA-PLUSS (Akers Bio) No CapEx Performed in-house Simple 1 to 3 DAYS turnaround Rapid 10 MINUTE test Faster Cost per Test (U.S.) $150 - $300 (U.S.) $110 - $125 Significant Related Costs ~ $1,000 to $3,000 pharmacy costs ~ $2,000 to $6,000 extended length of hospital stay None for 80%+ of patients testing negative Better Value Key Value Driver Customer Value: Potential to save a typical U.S. hospital well over $1 Million annually 6

7 Multiple rapid tests have been developed in high margin markets; 5 are generating revenues now In Development Lung cancer breath test Asthma breath test Chronic Obstructive Pulmonary Disease breath test Diabetic ketoacidosis breath test Heart attack test Commercial Development Chlamydia test Malaria test Dengue Fever test Our rapid tests replace current testing methods Launched and Commercialized Heparin-induced thrombocytopenia test Cholesterol test Alcohol breath test Weight loss test Oxidative stress test 7

8 6 proprietary technology platforms provide the foundation for product development and external licensing Technology Platform MPC - Micro Particle Catalyzed Biosensor PIFA - Particle ImmunoFiltration Assay REA - Rapid Enzymatic Assay serastat SMC - Synthetic Macrocycle Complex Description Permits the rapid determination of biomarkers in breath condensate Selective filtration of microparticles in response to antibody / antigen binding Detection of blood and urine metabolites through enzymatic chemistries in quantitative or semi-quantitative formats Rapid production of Serum from Whole Blood in minutes through the use of membrane technology Novel organic macrocyclic compounds and electronic readers determine quantitative levels of therapeutic drugs Product Example Not yet commercialized mindna Analysis of DNA in one minute using a hand-held reader Not yet commercialized 8

9 Overview of Selected Commercialized Products 9

10 Sales Channels Status Usage Market Opportunity The only rapid test to detect a potentially fatal allergy (HIT) to the blood thinner Heparin 4 million HIT tests conducted annually in the U.S. alone all of which could be replaced with Akers PIFA test Results within 10 minutes vs hours for outsourced lab results Reduces unnecessary costs incurred with standard protocols, saving a typical U.S. hospital > $1 Million per year Selling To hospitals and clinics via: Leading U.S. medical device distributors Direct sales force Telesales partner Internationally via in-country distribution partners Growing Device Unit Sales 42,000 96,000 HIT = Heparin-Induced Thrombocytopenia

11 Sales Channels Status Usage Market Opportunity The only combined rapid test for Total, HDL and LDL cholesterol 36 million people take cholesterol reducing agents in U.S. alone, and an additional 36 million are indicated for such treatment 3 minute result from finger stick blood sample In-office, in-home, mass screening and remote locations Selling Physicians offices (U.S.) Public health clinics (U.S.) Developing world markets where laboratory infrastructure not yet established Middle East and Australia through distribution partner Currently evaluating sales channels in E.U. and Asia 11

12 Sales Channels Status Usage Market Opportunity Akers Wellness Lync TM New, personalized approach to informing the current Health & Wellness of an individual Antioxidants and weight loss products - multi-billion dollar markets. Akers Wellness Lync TM provides valuable health information in a consumerfriendly format Akers Wellness Lync TM app-enabled, multi-device reader, providing easy, quantified personal health information METRON Breath-based device providing rapid, non-invasive identification of optimal fat-burning state for weight loss (nutritional ketosis) VIVO Breath-based device providing rapid, non-invasive determination of free radical levels and the efficacy of antioxidant supplementation METRON and VIVO launched Akers Wellness Lync TM available Q Distribution via Health and Wellness companies Multi-level marketing organizations Weight loss centers Health and fitness clubs 12

13 Overview of Selected Pipeline Products 13

14 Next Steps Status Usage Market Size Breath PulmoHealth Breath tests for biomarkers indicating Lung Cancer, Asthma and COPD LUNG CANCER: > 1.6 million people worldwide diagnosed annually ASTHMA: 300 million people worldwide diagnosed; prevalence up to 18% COPD: 210 million people currently in treatment; up to 1 billion smokers at risk Single-use, non-invasive device for pulmonary health screenings with the capacity to dramatically change the speed and cost of diagnosing major respiratory conditions In commercial development File 510(k) for FDA clearance. In order of filing: Asthma, COPD, Lung Cancer Seek distribution as companion diagnostics with prescription medicines; partner with primary care-based diagnostic sales organizations and distributors that market to retail health clinics 14

15 Next Steps Status Usage Market Opportunity BreathScan DKA First breath test to identify the potentially fatal diabetic condition - diabetic ketoacidosis 28.5 million Type 1 diabetics worldwide require 1+ test/week for diabetic ketoacidosis (DKA) Breath test to replace hospital visit and lab testing In commercial development File 510(k) for FDA clearance Initial distribution into teaching hospitals, centers of excellence and diabetes centers 15

16 Next Steps Status Usage Market Opportunity PIFA Chlamydia First rapid finger stick blood test for chlamydia Estimated 2.9 million infections occur annually in the U.S. alone Diagnostic test results typically returned in ~7 days, delaying treatment Screening and point-of-care settings, enabling immediate treatment In clinical development File 510(k) and CE mark Initial distribution into STD clinics 16

17 Akers is growing revenues year-on-year FY2014 Revenues: $ 4,427,174 Gross Profit: $ 3,251,942 Profit Before Tax: $(3,127,167) Earnings Per Share: $(0.66) $1.5m $3.6m $4.4m FY 2012 FY 2013 FY

18 A strong balance sheet gives Akers the resources to develop and grow Cash & Marketable Securities Total Assets Total Liabilities As at Dec 31, 2014 Dec 31, 2013 $9,720,802 $103,634 $16,650,872 $6,075,622 $1,843,986 $1,953,388 Total Equity $14,806,886 $4,122,234 18

19 Experienced, focused executive team Raymond F. Akers, Jr. Ph.D. Founder, Executive Chairman of the Board 30+ years in medical diagnostics; founded Akers in 1989 Invented most of Akers products and technologies; holds numerous patents Ph.D. in Neurochemistry, Northwestern University Nicolas Daurel Vice President, Sales and Marketing, EMEA 20+ years experience in international sales Held similar positions with Trinity Biotech plc, Diagnositica Stago, SA, Roche Diagnostics John C. Cheneval Senior Vice President, Sales and Marketing 25+ years high level industry experience including within Johnson & Johnson, Novartis Molecular Diagnostics and Genoptix Medical Labs Recognized leader in commercializing diagnostic products in healthcare sector Responsible for launch and management of several hundred million dollars of diagnostic product sales Christopher Ellis Vice President, Global Marketing Led provider marketing for Vree Health, LLC, a subsidiary of Merck, one of the largest pharmaceutical companies in the world 12 years in various positions of increasing responsibility within sales and marketing at Merck 19

20 Experienced, focused executive team Gary M. Rauch Vice President, Finance 35+ years in accounting, information systems, and operations consulting Engagements in healthcare, manufacturing and distribution Richard E. McKee Vice President, Engineering 40+ years in product design, development and consulting for automated manufacturing equipment in medical diagnostics, pharmaceuticals, food, glass, and automotive Adjunct Professor of Engineering George J. Awad Director, Corporate & Legal Affairs Registered patent attorney with 18+ years corporate/ip legal/corporate development experience. Specialization in developing, driving, and deploying full cycle commercialization/growth plans across various technology industries. Adam C. Sobel M.D. Director, Medical MD, Internal Medicine, Jefferson Medical College, Philadelphia, PA Responsibility for overseeing Akers clinical trials Attending physician at Thomas Jefferson University Hospital, Pennsylvania Hospital, Methodist Hospital, Penn Medicine, Main Line Health System, Nazareth Hospital Member, American Medical Association, American College of Physicians 20

21 Supported by experienced non-executive directors Thomas J. Knox Non-Executive Co-Chairman of the Board Expertise in health care and finance Former CEO of United Healthcare of Pennsylvania; Former Chairman of the Board and Chief Executive Officer of Fidelity Insurance Group, Inc. Candidate for Mayor of Philadelphia (2007) and candidate for Governor of Pennsylvania (2010) Brandon T. Knox Non-Executive Director Experience in corporate finance and financial management Currently wealth advisor at Raymond James Gavin E.D. Moran Non-Executive Director Extensive experience in trading, finance and marketing Trading roles at Shell International, Trafigura A beneficial shareholder of Sono International Ltd (a significant shareholder in Akers) 21

22 1. Enhance Sales and Distribution 2. Launch New Rapid Tests 3. Develop New Rapid Tests Clear path to grow value Expand sales organization Leverage costs savings message Expand international distribution in key markets Diabetic ketoacidosis breath test Chlamydia test Asthma breath test Lung cancer breath test COPD breath test Heart attack test Establish U.S. partnerships to distribute Cholesterol tests and Akers Wellness products 22

23 Summary Growing Product Portfolio Growing Revenues Growing Global Market Multiple products already generating sales Large targeted markets provide dramatic growth potential Strong new product pipeline, with patented technologies Sales growing year-on-year Clear path for continued growth Underpinned by strong cash position Positioned to capitalize on growth of point-of-care medical device market Healthcare cost pressures favor the value propositions of Akers tests 23

24 CONTACT a:, 201 Grove Road, Thorofare, N.J , USA t: +1 (856) e: