Genetic Signatures Ltd. · ASX:GSS

Genetic Signatures — Shareholder Meeting (November 2016)

27 slides from Genetic Signatures's shareholder meeting presentation, Nov 29, 2016

  1. Slide 1: Annual General Meeting – 2016

    Annual General Meeting – 2016 1

  2. Slide 2: Disclaimer

    Disclaimer This presentation was prepared by Genetic Signatures Limited known as “Genetic Signatures“, (“GSS” or “the Company”), in order to discuss its business with various interested parties. This presentation in its entirety has been released to the market via the Australian Securities Exchange

  3. Slide 3: Company Overview

    Company Overview  Genetic Signatures Limited (GSS) designs and manufactures proprietary molecular diagnostic (MDx) test solutions for rapid and specific identification of diseases and infections  GSS fully owns its proprietary molecular 3Base™ technology with multiple patents issued, expiring in 2

  4. Slide 4: Recent Achievements

    Recent Achievements 2000  Strong sales growth with a 3yr CAGR of Annual Revenue 92% 1800 3yr CAGR of 92%  FY16 revenue of A$1.83M, split ~80% 1600 Gastroenteritis and ~20% Respiratory specialist sales 1400  Recently completed oversubscribed $15M $Thousands (A$) capital raising 1200 Respiratory 

  5. Slide 5: Corporate Summary

    Corporate Summary Financial Information (A$) Top Shareholders % ASX Code GSS Asia Union Investment Pty 35.3% Limited Shares on Issue 104.6M Market Capitalisation $50.2M Pan Australian Nominees Pty Ltd 14.2% Share Price (at market close 25 UBS Nominees Pty Ltd 6.5% $0.48 November 2016) Directors, Man

  6. Slide 6: Experienced Board and Management

    Experienced Board and Management Nick Samaras - Non-Executive Chairman More than 25 years experience in the global life sciences industry, including Applied Biosystems (now part of Thermo Fisher) and Perkin Elmer. Founder of consulting firm Australis Biosciences and Director of the AGRF and MuriGen

  7. Slide 7: Genetic Signatures: Transforming Global Molecular Diagnostics

    Genetic Signatures Transforming Global Molecular Diagnostics 7

  8. Slide 8: Genetic Signatures - 3Base™ Technology

    Genetic Signatures - 3Base™ Technology A transformational MDx technology enabling customers to identify a wider array of patient infections  GSS’ 3Base™ platform is a proprietary molecular technique which changes naturally occurring DNA and RNA sequences to reduce sequence variation between subtype

  9. Slide 9: Unique 3Base™ Technology

    Unique 3Base™ Technology  GSS’ unique platform technology converts original 4-base microbial genome to 3-base, thereby reducing complexity in molecular testing  Applicable in testing for infectious diseases and chronic diseases including cancers  The conversion occurs during standard procedures a

  10. Slide 10: Advantages of 3Base™ Technology

    Advantages of 3Base™ Technology Patient Pathology Groups / Government Hospitals  Patients receive more  Cost savings due to  Reduces hospital stays accurate test results decreased time spent through more effective  Faster turn around evaluating samples infection detection time: 4-5 hours vs. 4-5

  11. Slide 11: EasyScreen™ Testing Kits

    EasyScreen™ Testing Kits  First products to market:  22 gastroenteritis pathogens including viral, bacterial and protozoan  15 common respiratory infections  Being adopted by major hospitals and pathology laboratories for detection of infectious diseases  Deliver a wider array of highly specifi

  12. Slide 12: EasyScreen™ Products in Development

    EasyScreen™ Products in Development  Product expansion will drive revenue and market share growth  Product development pipeline includes tests for:  2nd generation respiratory virus  Atypical pneumonia  STIs with clinical evaluation trial announced in September  Antibiotic resistance panel  M

  13. Slide 13: EasyScreen™ STI Detection Kit

    EasyScreen™ STI Detection Kit Panel A Panel B Panel C Panel D C. trachomatis M. genetalium Candida spp. T. pallidum N. gonorrhoeae T. vaginalis M. hominis HSV-1 LGV Ureaplasma spp. S. agalactiae HSV-2 Extraction Control  STIs significantly impact sexual and reproductive health with WHO reporting 1

  14. Slide 14: Traditional STI Testing Methods

    Traditional STI Testing Methods Test Amplification Run frequency C. trachomatis Cobas 4800 Mon-Fri N. gonorrhoeae Cobas 4800 Mon-Fri HSV 1/2 Simplexa Mon, Wed, Fri LGV Send away test Weekly T. palladium Send away test Weekly T. vaginalis Wet prep only Daily Mycoplasma spp. Send away test Weekly Urea

  15. Slide 15: Results from 729 Specimens

    Results from 729 Specimens Pathogen detected EasyScreenTM Hospital Traditional C. trachomatis 38 31 N. gonorrhoeae 24 27 LGV 3 (7.9%) To be confirmed* M. genetalium 8 Not tested T. vaginalis 8 4 Ureaplasma spp. 263 Not tested Candida spp. 149 94 M. hominis 64 Not tested S. agalactiae 84 51 T. pallid

  16. Slide 16: Results - 25.9% of the samples had mixed infection

    Results - 25.9% of the samples had mixed infection (≥2 pathogens detected) Pathogen Hospital Confirmatory Sensitivity Specificity Specimen type EasyScreenTM detected Traditional test (%)Ψ (%)Ψ Genital Swab (n = 550) 17 11⌘ 17 100.0 100.0 C. trachomatis Throat Swab (n = 19) 1 1 1 100.0 100.0 Urine (n

  17. Slide 17: Global Growth Strategy and Commercial Progress

    Global Growth Strategy and Commercial Progress 17

  18. Slide 18: Growing Global Molecular Diagnostics Market

    Growing Global Molecular Diagnostics Market  Molecular Diestimatedics (MDx) Market estimated to be US$7.6B in 2017 representing 11% of the overall in vitro Diagnostics (IVD) market of $US69B  MDx market forecast to grow at an above system CAGR of 9.3% exceeding overall IVD market growth as MDx tec

  19. Slide 19: Large Addressable Markets

    Large Addressable Markets  GSS’ current diagnostics products and pipeline products account for >50% of microbiology/virology diagnostics segment  This total addressable market was $US1.1B in 2012 and estimated to be worth US$2.1B by 2017 2017 Estimate of Microbiology/Virology 2017 Estimate of GSS

  20. Slide 20: Regulatory Approvals Now Secured in Large Portion of Global Market

    Regulatory Approvals Now Secured in Large Portion of Global Market - Driving Revenue  Full regulatory approval for ~22% of the global market in Gastroenteritis testing, with partial approval (Clinical Concentrators, Analyte 2017 Estimate MDx Market Size by Region (USD) Specific Reagents) in the USA

  21. Slide 21: Significant Offshore Opportunity

    Significant Offshore Opportunity  Strong revenue growth in Australia validates commercial potential of products in offshore markets  Full regulatory approval for ~22% of the global market (Australia and Europe) - Enteric products have CE-IVD approval in Europe which is 10-20x Australian market  S

  22. Slide 22: Global Growth Strategy

    Global Growth Strategy  Focus on regions with regulatory approvals  Australia, Europe and US = >80% of world market  Extend footprint in both Europe and US  Europe has unique testing and reimbursement strategies – local knowledge is critical  Full distributor model in select countries, with loc

  23. Slide 23: Commercialisation Progress – Australia

    Commercialisation Progress – Australia  Major hospital and pathology group customers including St. Vincent’s Sydney and Australian Clinical Labs  Driving strong revenue growth for Australian sales: 92% 3yr CAGR  Two new products to be released in next 6-12 months  STI testing kit in clinical val

  24. Slide 24: Commercialisation Progress - Europe

    Commercialisation Progress - Europe  Addressable market of ~US$435M  Western Europe = ~20% global molecular diagnostics market  Anticipate first significant revenues in FY17  European Director appointed  Distributors in Italy, Israel, Poland & Ireland with hospital tenders and trials underway 

  25. Slide 25: Commercialisation Progress - North America

    Commercialisation Progress – North America  Up to ~US$1,265M addressable market  US = 50-60% global molecular diagnostics market  Anticipate first sales in FY17  US FDA listing for Clinical Sample Concentrator achieved in FY16 provides base for future revenue  EasyScreen™ Sample Processing Kits

  26. Slide 26: Outlook

    Outlook Further strong growth expected in FY17  FY16 sales revenues of AU$1.83m, representing a 3yr CAGR of 92%  Launch of specialist products for sale into Australia and prepared for US  Alliances made with leading KOL and health laboratories in the US and globally Progressing significant offsho

  27. Slide 27: Contact: John Melki, Chief Executive Officer

    Contact: John Melki Chief Executive Officer john@geneticsignatures.com www.geneticsignatures.com 27

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