Genetic Signatures Ltd. · ASX:GSS
Genetic Signatures — Investor Presentation (September 2023)
34 slides from Genetic Signatures's investor presentation, September 2023
Slide 1: 1H FY23 Market Update: US Commercial Launch
1H FY23 MARKET UPDATE July 2023 Investor Presentation US Commercial Launch September 2023 1
Slide 2: Disclaimer
1H Investor Presentation FY23 MARKET UPDATE Disclaimer September 2023 July 2023 This presentation has been prepared by Genetic Signatures Limited ACN 095 913 205 (the Company or GSS) and approved by the Board of Directors for release. It comprises written materials/slides for a verbal presentation c
Slide 3: Introduction
1H Investor Presentation FY23 MARKET UPDATE Introduction September 2023 July 2023 Proprietary 3base® technology platform • A revolutionary approach to molecular diagnostic assays for infectious diseases Simplifies multiple pathogen testing from a single sample • Multiplexing; more informative and si
Slide 4: US commercial launch underway
1H Investor Presentation FY23 MARKET UPDATE US commercial launch underway September 2023 July 2023 First product submitted to FDA for sales clearance New image The EasyScreen™ Gastrointestinal Parasite Detection Kit addresses an unmet need • Broadest molecular syndromic test for 8 clinically relevan
Slide 5: Company snapshot
1H Investor Presentation FY23 MARKET UPDATE Company snapshot September 2023 July 2023 Financial information Share price (13-September-23) A$0.53 Shares on issue 143.4m Market capitalisation A$76.0m Cash (30-Jun-23) A$16.3m Debt (30-Jun-23) Nil Enterprise value A$59.7m Top shareholders % Asia Union 2
Slide 6: Extensive US commercial and regulatory experience
1H Investor Presentation FY23 MARKET UPDATE Extensive US commercial and regulatory experience September 2023 July 2023 Nick Samaras Michael Aicher John Melki Non Executive Chairman Executive Director Managing Director and CEO • Significant experience leading • Currently based in the US with • Led gl
Slide 7: Proprietary 3base technology simplifies molecular targets
1H Investor Presentation FY23 MARKET UPDATE Proprietary 3base® technology simplifies molecular targets September 2023 July 2023 Molecular diagnostic tests are based on DNA/RNA sequences • DNA/RNA is unique to each organism Genetic Signatures 3base® makes multiplex testing easier: • More informative
Slide 8: 3base simplifies syndromic testing – EasyScreen kits
1H Investor Presentation 3base® simplifies syndromic testing – EasyScreen™ kits FY23 MARKET September UPDATE 2023 July 2023 Syndromic testing: test for multiple pathogens that all can cause the same signs and symptoms • Respiratory infections: cough, runny nose, sore throat, headache • Gastrointesti
Slide 9: Robust pipeline with multiple products cleared for sale
1H Investor Presentation Robust pipeline with multiple products cleared for sale FY23 MARKET September UPDATE 2023 July 2023 DEVELOPMENT RESEARCH USE REGISTRATION TGA CE Mark FDA In clinical trials Submitted Converting to new protocol In development 9
Slide 10: Strong underlying growth in core revenue streams
1H Investor Presentation FY23 MARKET UPDATE Strong underlying growth in core revenue streams September 2023 July 2023 FY23 sales $16.9 million • Anticipated decline in pathogen-specific molecular testing for SARS-CoV-2 experienced across the industry • Replaced with growing syndromic respiratory sal
Slide 11: Annual Sales Revenue (A$m)
1H Investor Presentation FY23 MARKET UPDATE Strong underlying growth in syndromic revenue streams September 2023 July 2023 Annual Sales Revenue (A$m) Focusing on increasing sales revenue from EU and US Core syndromic testing solutions lift 38% in FY2023 • Company has invested for growth in internati
Slide 12: FY 2023 financial results
1H Investor Presentation FY23 MARKET UPDATE FY 2023 financial results September 2023 July 2023 A$'000s FY23 FY22 Reduced SARS-CoV-2 molecular testing replaced with Sales revenue 16,939 35,421 growing syndromic respiratory sales: Cost of materials & freight (7,996) (11,989) • Sales revenue of $16.9 m
Slide 13: Substantial investments made in growth
1H Investor Presentation FY23 MARKET UPDATE Substantial investments made in growth September 2023 July 2023 • International markets • Internal capabilities (clinical, regulatory) • New products; regulatory clearances • Technology improvements; • Product launches • Sample-to-result instrument Capital
Slide 14: Next Generation Instrument development
Investor Presentation Next Generation Instrument development September 2023 “Sample-to-result” Instrument Value Position • Highly automated, little hands-on time • Future proof GSS in global MDx • High-throughput (~400 samples/shift) market • Same testing parameters for all panels – • Address a mark
Slide 15: Case Study – Sales ramp in Australian customer
Investor Presentation Case Study – Sales ramp in Australian customer September 2023 Excellence customer support and product performance supports long-term customer relationship TODAY Back to core business strength with growth in syndromic testing • Early Adopter evaluated 3base® Easyscreen™ detectio
Slide 16: FDA filing for EasyScreen Gastrointestinal Parasite Detection Kit
FDA filing for EasyScreenTM Gastrointestinal Parasite Detection Kit Launching into World's Largest Molecular Diagnostic Market
Slide 17: Current testing protocols are complex and inefficient
Investor Presentation Current testing protocols are complex and inefficient September 2023 EasyScreenTM Gastrointestinal Parasite Detection Kit is expected to disrupt traditional standard ova & parasite testing “The majority of diagnostic parasitology testing is categorized as high complexity, requi
Slide 18: North America represents 40% of diagnostic market
Investor Presentation North America represents 40% of diagnostic market September 2023 United States has a significant commercial opportunity for testing for gastrointestinal parasites • 5.5 million tests conducted in the US per annum • No competing FDA approved molecular tests for detection of 8 pa
Slide 19: Positive feedback from users in US testing laboratories
Investor Presentation Positive feedback from users in US testing laboratories September 2023 “Molecular is going to impact patient management in three ways. Your results will come back quicker, they will potentially be more accurate, and they will also help redirect the evolving differential diagnos
Slide 20: 4 Year investment in US opportunity
1H Investor Presentation 4 Year investment in US opportunity FY23 MARKET September UPDATE 2023 July 2023 US market preparation activities since 2019 • Clinical trial commenced in 2020 in 3 US sites • Delivery of an educational webinar series and white paper involving industry parasitology experts wi
Slide 21: Preparations for commercial sales in the US well advanced
Preparations for commercial sales in the US well Investor Presentation September 2023 advanced Focused prospects • Targeting the top 30-50 mid to high throughput laboratories in the US • 80/20 rule with majority of tests conducted by 20% of sites • Allows direct sales effort Direct sales model • Hig
Slide 22: Preparations for commercial sales in the US well advanced
Investor Presentation Preparations for commercial sales in the US well advanced September 2023 Commercial sales expected to start soon after FDA clearance • Customer experience sites expected to transition to a purchasing customer • Solid opportunity pipeline supported by sales and marketing efforts
Slide 23: Four distinct customer segments – all targets
Investor Presentation Four distinct customer segments – all targets September 2023 Projected GSS tests / site (% Testing Potential test volume Potential customers of testing) requirements • LabCorp Large Commerical • Quest High volume 1.65 million 50 • Sonic Health Reference Labs LabCorp / Quest = >
Slide 24: Advantages for US customers
Investor Presentation Advantages for US customers September 2023 Advantages for laboratory diagnostic services • Fast time to result — improve laboratory workflow • Highly reliable and sensitive test • Ease of use — support diverse technical experience • Minimal ‘hands on’ time • Able to scale up or
Slide 25: Outlook - near term value drivers
1H Investor Presentation Outlook - near term value drivers FY23 MARKET September UPDATE 2023 July 2023 US EasyScreenTM Gastrointestinal Parasite Detection Kit • 510(k) clearance • Launch product once clearance is granted Complete US clinical trial for next EasyScreen™ product • Syndromic detection k
Slide 26: Appendix
§ genetic Signatures Appendix “2 raha “it ¥
Slide 27: Genetic Signatures revenue model
Genetic Signatures revenue model Investor Presentation September 2023 3base EasyScreenTM detection kits span across a broad range of disease areas; many available as registered products in Europe, Canada and Australia Products GSS can cater for an end-to-end, low to high-throughput syndromic te
Slide 28: Executing a global strategy: Australia
Investor Presentation Executing a global strategy for commercialisation September 2023 Australia: Expansion of local footprint 1 ü 11 tests now registered with TGA for sale to detect respiratory, gastrointestinal infections and antimicrobial resistance testing ü Already secured 1 of the 3 major path
Slide 29: Executing a global strategy: Europe and Middle East
Investor Presentation Executing a global strategy for commercialisation September 2023 2 Established and growing presence in Europe and Middle East ü Solid sales and marketing efforts driving increased brand recognition in the region ü Broad range of CE-IVD Marked tests available for sale in Europe
Slide 30: Executing a global strategy: North America
Investor Presentation Executing a global strategy for commercialisation September 2023 3 North America: Preparation for market entry underway, with first 510(k) submission to FDA for gastrointestinal parasite test ü EasyScreenTM Gastrointestinal Parasite Detection Kit submitted to FDA for regulatory
Slide 31: 3base supports appropriate treatment for infection
3base® supports appropriate treatment for infection Investor Presentation September 2023 Protozoan Pathogen Symptoms Antibiotic Giardia lamblia/intestinalis Metronizadole, tinidazole, nitazoxanide Common set of symptoms from all gastric protozoan Cryptosporidium spp. Nitazoxanide (some patients) inf
Slide 32: Business development activity in expanding markets
1H Investor Presentation Business development activity in expanding markets FY23 MARKET September UPDATE 2023 July 2023 Recent Key appointments • Distributor Channel Manager – Europe • Regulatory Affairs and Quality Assurance Manager – Europe • Head of Clinical Operations – North America New channel
Slide 33: EasyScreen Gastrointestinal Parasite Detection Kit: Automated syndromic workflow
EasyScreenTM Gastrointestinal Parasite Detection Kit Investor Presentation September 2023 Automated syndromic workflow Higher sensitivity and specificity Workflow automation Quicker turnaround times Able to combine multiple targets into single assay 1-60 Since using Genetic Signatures’ molecular pan
Slide 34: Contact Us
Contact Us Dr John Melki Managing Director & Chief Executive Officer E: john.melki@geneticsignatures.com P: +61 (0)2 9870 7580 Karl Pechmann Chief Financial & Operating Officer & Company Secretary E: karl.pechmann@geneticsignatures.com Visit us www.geneticsignatures.com Follow us 34
Genetic Signatures — Investor Presentation (September 2023) on 6ix