Genetic Signatures Ltd. · ASX:GSS
Genetic Signatures — Non-Deal Roadshow (July 2016)
37 slides from Genetic Signatures's roadshow presentation, July 2016
Slide 1: Investor Presentation – July 2016
Investor Presentation – July 2016 1
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
Slide 3: Company Overview
Company Overview § Genetic Signatures Limited (GSS) designs and manufactures proprietary molecular diagnostic test solutions for rapid and specific identification of diseases and infections § GSS fully owns its proprietary molecular 3Base™ technology with multiple patents issued, expiring 2031 § Pro
Slide 4: Corporate Summary
Corporate Summary Financial Information (A$) Top Shareholders % ASX Code GSS Asia Union Investment Pty Limited 50.6% Shares on Issue 72.81m DAK Drafting Services Pty Ltd 2.7% Market Capitalisation $36.4m UBS Nominees Pty Ltd 2.4% Share Price (at market close 20 July, 2016) $0.50 Directors, Managemen
Slide 5: Recent Achievements
Recent Achievements 2000 § Strong sales growth, with a 3-year CAGR of Annual Sales Revenue 92% 1800 3yr CAGR of 92% § FY16 revenue of A$1.83M, split ~80% 1600 Gastroenteritis, ~20% Respiratory specialist 1400 sales $Thousands (A$) 1200 § Advancing R&D development of 5 new Respiratory Respiratory dia
Slide 6: Large and Growing Global Molecular Diagnostics Market
Large and Growing Global Molecular Diagnostics Market § Molecular Diagnostics (MDx) Market estimated to be US$7.6Bn in 2017 representing 11% of the overall in vitro Diagnostics (IVD) market of $US69.1Bn § MDx market forecast to grow at an above system CAGR of 9.3% far exceeding the overall IVD marke
Slide 7: Large addressable markets
Large addressable markets § Genetic Signatures’ (GSS) current diagnostics products and pipeline products account for >50% of microbiology/virology diagnostics segment, representing what was a total addressable market of $US1.11Bn in 2012 § This segment is estimated to be worth US$2.1Bn by 2017 2017
Slide 8: Regulatory approvals already gained in large portion of US$7.6Bn global market
Regulatory approvals already gained in large portion of US$7.6Bn global market - driving revenue § Full regulatory approval for ~22% of the global market in Gastroenteritis testing, with 2017 EsKmate MDx Market Size by Region (USD) partial approval (Clinical Concentrators, Analyte Specific Reagents)
Slide 9: Significant Offshore Opportunity
Significant Offshore Opportunity § Strong revenue growth in Australia validates commercial potential of products in offshore markets § Enteric products have full approval in Europe which is 10-20x Australian market § Specialist clinical sales of Enteric ASR tests into N. America commencing in FY17 §
Slide 10: Experienced Board and Management
Experienced Board and Management Nick Samaras - Non-Executive Chairman BSc (Hons), PhD, MBA, FAIM, FAICD § More than 25 years’ experience in the global life sciences industry, senior executive roles with Applied Biosystems (now part of Thermo Fisher) and Perkin Elmer § NHMRC Research Committee membe
Slide 11: Experienced Board and Management
Experienced Board and Management Tony Radford, AO - Non-Executive Director BSc (Hons), PhD § A member of the CSIRO team that invented the QuantiFERON method for Cellular Immune based diagnostics § Co-founded the diagnostic company Cellestis Limited which listed on the ASX in 2001 § Former CEO of Cel
Slide 12: Genetic Signatures: Transforming Global Molecular Diagnostics
Genetic Signatures Transforming Global Molecular Diagnostics 12
Slide 13: 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
Slide 14: Technology - 3Base™
Technology - 3Base™ § Massive reduction in complexity § e.g, a 10 digit number comprised of the numbers 1,2,3 and 4 has 1,048,576 combinations § a 10 digit number comprised of the numbers 1,2 and 3 has 59,049 combinations § Reduces complexity by 97% yet maintains or increases accuracy § Sufficient i
Slide 15: EasyScreen™ Testing Kits
EasyScreen™ Testing Kits § GSS’ suite of EasyScreen™ products are being adopted by major hospitals & pathology laboratories in Australia for detection of infectious diseases § Products work to deliver a wider array of highly specific results in 4-5 hours that would have traditionally taken 4-5 days
Slide 16: Case Study: St Vincent's Hospital Evaluation Study
Case Study: St Vincent’s Hospital Evaluation Study - Powerful evidence of efficacy Pathogen Conventional EasyScreen™ § 221 patient samples compared to Methods* traditional culture, microscopy and Campylobacter 7 9 antibody based tests Salmonella 8 9 Shigella 5 6 § Results in 4 hours, compared to up
Slide 17: Customer testimonial: Dr Damien Stark
“I find that the fast turnaround time and the number of targets tested in the EasyScreen™ assays allow me to more rapidly identify highly infectious agents, potentially stopping the spread to other healthy individuals and thereby saving the health system money.” - Dr Damien Stark, KOL and Senior Mic
Slide 18: Advantages of 3base™ Technology
Advantages of 3base™ Technology Significant benefits to the health system Pathology Groups / Government Patient Hospitals § Patients receive more § Cost savings due to § Reduce hospital stays accurate test results decreased time spent through more effective § Faster turn around time; evaluating samp
Slide 19: Global Growth Strategy and Commercial Progress
Global Growth Strategy and Commercial Progress 19
Slide 20: Global Growth Strategy
Global Growth Strategy § Focus on regions with regulatory approvals § Australia, Europe and US, together account for >80% of world MDx market § Extend footprint in both Europe and US § Europe has unique testing and reimbursement strategies – local knowledge is critical § Full distributor model in se
Slide 21: Commercialisation Progress - Australia
Commercialisation Progress - Australia § Currently in market with 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 § FY16 Sales revenue up 75% to AU$1.83M § Revenue split ~ 80%
Slide 22: Commercialisation Progress - Australia (Cont)
Commercialisation Progress - Australia (Cont) § Dedicated R&D labs and network of clinical partners driving new product development § 4 EasyScreen™ products for Gastroenteritis have TGA approval § C. difficile detection and reflex kits; Enteric Protozoan & Bacterial Kits § 2 more EasyScreen™ kits ar
Slide 23: Commercialisation Progress - Europe
Commercialisation Progress - Europe § Western European market ~20% of the global molecular diagnostics market § Addressable market of ~US$435M § Targeting first significant recurring revenues in FY17 § Full distributors appointed in Italy, Israel, Poland and Ireland § Currently setting up trials and
Slide 24: Commercialisation Progress - Europe
Commercialisation Progress - Europe § 2 more EasyScreen™ kits are being validated for CE-IVD approval § For Respiratory and Enteric Viral infections § European Director, Sales and Support, appointed, based in the Netherlands § Establishing direct Sales and Support in Europe § Mix of Direct sales and
Slide 25: Commercialisation Progress – North America
Commercialisation Progress – North America § US market 50-60% of the global molecular diagnostics market § Up to ~US$1,265M addressable market § Anticipate first sales in FY17 § Direct sales and support model with established and experienced US team § Early revenue underpinned by US FDA listing for
Slide 26: Commercialisation Progress – North America
Commercialisation Progress – North America § UCLA evaluation concluded with successful product trial, publication to follow and progressing to adopt into routine use § First products are being prepared for full FDA approval, allowing unrestricted sales in the US § FDA approval opens pathway to a bro
Slide 27: Outlook
Outlook § Significant progress made during FY16 & further strong growth expected in FY17 § FY16 sales revenues of AU$1.83M, representing a 3 year 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 U
Slide 28: Appendix
6 senetic Signatures Appendix N
Slide 29: Comparable companies demanding large valuations
Comparable companies demanding large valuations § Comparable companies within the molecular diagnostics field trade on an average revenue multiple of 8.6x § This multiple exists under the spectre of the 3 year CAGR of the three closest comparable companies being an average of 9.1% § GSS’ 3 year CAGR
Slide 30: Technology - 3Base™
Technology - 3Base™ A transformational MDx technology enabling customers to identify a wider array of patient infections § Genetic Signatures’ 3Base™ platform is a proprietary molecular technique which changes naturally occurring DNA and RNA sequences to reduce sequence variation between subtypes §
Slide 31: 3base™ Simplifying Pathology Testing
3base™ Simplifying Pathology Testing § Pathology providers strive to Minimise work, Maximise results § Desire to get more results per patient specimen § Thus put more and more primers and probes for more and more diseases in a single tube and sample, to get more answers with less work - multiplexing
Slide 32: 3base™ Simplifying Pathology Testing
3base™ Simplifying Pathology Testing More Primers, more Probes, more Problems Conventional PCR - at some point the trade off in problems limits the Interference multiplex capacity with specificity and or sensitivity GSS solution allows more results with less work Primer probe numbers Number of resul
Slide 33: 3base™ Advantages
3base™ Advantages GSS is winning market share due to the following: § Unique 3base™ products that screen over 20 pathogens, including RNA and DNA viruses, in a probe based real-time format § No post amplification analysis required § Uses latest technology compatible with existing equipment (open pla
Slide 34: Immense US Market Potential
Immense US Market Potential § US has 5,686 registered hospitals § Over 900,000 staffed beds § Over 35 million admissions § 11,000 CLIA certified laboratories § 3Base™ Technology offers unique advantages for the US Market § High numbers of pathogens detected delivers desirable patient outcomes § Assa
Slide 35: US Market Trends
US Market Trends § Centers for Disease Control and Prevention (CDC) estimates that annually, at least two million illnesses and 23,000 deaths are caused by antibiotic-resistant bacteria in the United States alone § The Infectious Disease Society of America produced a policy paper “Better Tests, Bett
Slide 36: US Market Expansion Approach
US Market Expansion Approach § Discussions underway with Key Opinion Leaders to trial Genetic Signatures’ technology § Patient outcome studies – define superior patient care through implementation of broad pathogen screening protocols § Head-to-Head comparison between 3Base™ assays and traditional m
Slide 37: Contact: John Melki Chief Executive Officer
Contact: John Melki Chief Executive Officer john@geneticsignatures.com www.geneticsignatures.com 37