Lumos Diagnostics Holdings Ltd. · ASX:LDX
Lumos Diagnostics — Investor Presentation (September 2024)
55 slides from Lumos Diagnostics's investor presentation, Sep 23, 2024
Slide 1: ASX Announcement: Lumos Investor Roadshow Presentation and Briefing Session Reminder
ASX ANNOUNCEMENT Lumos Investor Roadshow Presentation and Briefing Session Reminder For personal use only Key highlights: Presentation to be delivered during this week’s investor roadshow attached. Investor briefing sessions to be held this Tuesday in Melbourne and Wednesday in Sydney. RSVP dead
Slide 2: Briefing registration and About Lumos Diagnostics
To register your interest to attend either briefing, please email Pip Thorn via pip.thorn@irdepartment.com.au or phone +61 404 839 848 by end of day today. The Lumos team looks forward to seeing all those investors able to attend. -Ends- This announcement has been approved by the Lumos Disclosure Co
Slide 3: Lumos Diagnostics Investor Roadshow Presentation
For personal use only Lumos Diagnostics Holdings Limited Investor Roadshow Presentation 23 September 2024 The consolidated entity’s presentation currency is US Dollars. Financial information is shown in USD unless otherwise stated. Entitlement Offer and Share Price information is shown in AUD, as th
Slide 4: Disclaimer and Important Information
Disclaimer and Important Information This presentation (Presentation) has been prepared solely for informational purposes by Lumos Diagnostics Holdings Limited (ACN 630 476 970) (“Lumos” or “Company”). The information contained in this Presentation has been prepared by Lumos. This Presentation is cu
Slide 5: Disclaimer and Important Information
Disclaimer and Important Information This presentation (Presentation) has been prepared solely for informational purposes by Lumos Diagnostics Holdings Limited (ACN 630 476 970) (“Lumos” or “Company”). Neither the receipt of this Presentation by any person nor any information contained in it or supp
Slide 6: Company Overview
Company Overview Experienced leadership team • Led by Doug Ward (CEO/MD) - industry veteran with over 30 years' in diagnostics Lumos is a developer and • Experienced business/technical/commercial leaders also include For personal use only Barrie Lambert (CFO); Sacha Dopheide (CTO) & Paul Kase (SVP C
Slide 7: Key Highlights from FY24
Key Highlights from FY24 For personal use only FebriDx & ViraDx achieve US FDA Hologic IP and Development Expanded Henry Schein clearance and authorization respectively Agreement FebriDx distribution agreements 1H FY24 Non-refundable IP Agreement valued at In FY24, Spain, Portugal, Netherlands & US.
Slide 8: Financials – Summary FY24
Financials – Summary FY24 (US$ in thousands) REVENUE (US$’000) REVENUE MIX NET CASH GENERATION (US$’000)* For personal use only $4,340 100% $3,117 $4,025 80% $2,012 60% $1,655 40% $1,111 20% 0% Q1FY24 Q2FY24 Q3FY24 Q4FY24 Q1FY24 Q2FY24 Q3FY24 Q4FY24 -$2,777 -$2,763 Commercial Services Products Comme
Slide 9: Lumos Products
For personal use only Lumos Products
Slide 10: Product Portfolio Approach
Product Portfolio Approach For personal use only Be a leader in point-of-care Focus on verticals with existing Leverage broad partnering testing for women's health and markets / reimbursement / strategy to secure content, share sexual health, offering a transition from Core Lab to costs, and drive c
Slide 11: FebriDx: First-of-its-Kind Point-of-Care Test
FebriDx: First-of-its-Kind Point-of-Care Test FebriDx offers an aid for healthcare providers to improve patient care and antibiotic stewardship For personal use only • FebriDx is a rapid point-of-care respiratory test which delivers results after 10 minutes from a fingerstick blood sample. • Antibio
Slide 12: FebriDx addresses a major need: Antibiotic Overprescription
FebriDx addresses a major need: Antibiotic Overprescription ANTIBIOTICS PRESCRIBED IN THE U.S. BY TYPE ANTIBIOTICS PRESCRIBED HOW WE’RE DRIVING MARKET ADOPTION For personal use only Common cold Marketing and education Sinusitis • Microbial testing prior to prescribing antibiotics not currently routi
Slide 13: FebriDx Market Opportunity in the US > $1Billion
FebriDx Market Opportunity in the US > $1Billion MODERATE COMPLEXITY LIMITATION CLIA WAIVER EXPANDS ADDRESSABLE MARKET For personal use only Potential Customer Sites Potential Customer Sites 18,000 15x 270,000 Moderate Complex CLIA Waived • 18,0002 potential customer sites in US • 270,0002 potential
Slide 14: FebriDx Update
FebriDx Update • Reimbursement amount: PLA code update1 • Positive momentum - CMA Panel presentation in June was well For personal use only received, final decision expected Oct/Nov 2024 • Partnerships1 • 26 FebriDx partnerships in FY24: regional distributors and end-user customers • Immediate impac
Slide 15: FebriDx CLIA Waiver Study
FebriDx CLIA Waiver Study What is the study for…what is CLIA? • The Clinical Laboratory Improvement Amendment (CLIA) waiver study will demonstrate that the FebriDx test is simple to perform with a low risk of For personal use only erroneous results when performed by untrained users in expanded user
Slide 16: ViraDx – Point-of-Care test for key respiratory infections
ViraDx – Point-of-Care test for key respiratory infections ViraDx highly relevant POC test for post-pandemic environment: For personal use only • SARS-CoV-2 pandemic increased consumer and healthcare point-of-care testing • ViraDx is a 3-in-1 test for COVID-19/Flu A/Flu B ViraDx regulatory and comme
Slide 17: Lumos-Owned Product Development Strategy
For personal use only Lumos-Owned Product Development Strategy
Slide 18: Lumos Product Roadmap | Women's Sexual Health - $10B
Lumos Product Roadmap | Women’s Sexual Health - $10B For personal use only 1-2 DAYS PREVALENCE CLINICAL NEED POC DIAGNOSTIC NEED 30-40% of women Multiple infectious organisms Rapid testing on site >10M heath care visits annually Similar symptoms Identify & treat at patient visit Different treatments
Slide 19: Women's Sexual Health Products – Product One Program
Women’s Sexual Health Products – Product “One*” Program For personal use only CURRENT NEAR TERM MID TERM LONG TERM Distribute Products Visual Read Products Products on Partner Platforms Products on Lumos Reader HOSPITAL & DECENTRAL OB/GYN Womens Sexual Health - Distributor Womens Sexual Health - Lum
Slide 20: Services Business
For personal use only Services Business
Slide 21: How we add value to partners
How we add value to partners We work with partners through the whole diagnostic product development cycle, then provide support once their products are in market For personal use only Customer launch and support Manufacture Clinical studies Verification and validation of Conduct feasibility, require
Slide 22: Hologic - Strategic Partnership
Hologic - Strategic Partnership Hologic is a recognized global leader in women’s health based in Massachusetts, US $10m IP Agreement For personal use only • NASDAQ: HOLX, Market Capitalization ~US$18 billion payment received • FY2023 revenue of US$4.0 billion with net income of US$0.5 billion (dia
Slide 23: Fetal Fibronectin (fFN) background
Fetal Fibronectin (fFN) background A biomarker indicating a heightened risk of pre-term delivery when present in cervicovaginal secretions For personal use only fFN is the largest segment in the • Background pre-term diagnostic test kit market • fFN is protein found at the maternal-fetal interface.
Slide 24: Hologic - fFN product development overview
Hologic - fFN product development overview Current test: Rapid fFN TLiQ Next generation test concept (mock-up) For personal use only Benefits of the new technology • Latest state-of-the-art technology, with reader platform • Connectivity for improved digital patient record management • Developed and
Slide 25: Hologic – the opportunity ahead
Hologic – the opportunity ahead For personal use only Verification and validation Clinical study Manufacturing (readers and assay) Second test development and IP 23
Slide 26: Capital Raising
For personal use only Capital Raising Raising ~A$10m via Entitlement Offer to fully fund FebriDx CLIA waiver trial anticipated to read out in the middle of 2025. A successful trial and submission in Aug/Sep 2025 would likely expand the market for FebriDx in the US by more than 15x.
Slide 27: Priority Catalysts for Growth
Priority Catalysts for Growth For personal use only Monetize the Lumos cleared point-of-care test products, FebriDx and ViraDx, through sales, licenses and partnerships There is little doubt in my mind that point-of-care diagnostic tests are going to Complete a successful CLIA waiver trial for Febri
Slide 28: Capital Raising Details
Capital Raising Details • A 1 for 1.82 pro-rata accelerated non-renounceable entitlement offer to eligible shareholders of LDX to raise approximately A$10.0 million (‘Entitlement Offer’), comprising; • An Institutional Entitlement Offer raised $3.1 million; Firm commitments from Tenmile and Ryder re
Slide 29: Expected Use of funds
Expected Use of funds The funds raised under the Entitlement Offer provides balance sheet flexibility and drive strategic and targeted growth initiatives. For personal use only • Lumos expects to have pro-forma net cash as at 30 June 2024 of Sources of funds1 (US$ million) approximately US$13.2 mill
Slide 30: Timetable
Timetable Event1 Sydney, Australia time For personal use only Trading Halt Wednesday, 4 September 2024 Announcement of the Offer Wednesday, 4 September 2024 Institutional Entitlement Offer Opens Wednesday, 4 September 2024 Announcement of results of Institutional Entitlement Offer and trading halt l
Slide 31: Questions
For personal use only Questions
Slide 32: Appendix – Supplementary Info
For personal use only Appendix – Supplementary Info
Slide 33: Executive Summary
Executive Summary Raising ~A$10m via Entitlement Offer to fully fund FebriDx CLIA waiver trial anticipated to read out in the middle of 2025. A successful trial and submission in Aug/Sep 2025 would likely expand the market for FebriDx in the US by more than 15x. For personal use only Significant • F
Slide 34: Lumos Point-of-Care Diagnostic Test Development Engine
Lumos Point-of-Care Diagnostic Test Development Engine For personal use only DESIGN DEVELOP MANUFACTURE Lumos POC Design Engine Revenue Streams Contract Fees Transfer Price & Margin Sales & IP License Payments from services from manufacturing from own products & other products 32
Slide 35: Henry Schein Distribution Agreements
Henry Schein Distribution Agreements For personal use only • FebriDx is a rapid point-of-care respiratory test which delivers results after 10 minutes from a fingerstick blood sample. • Henry Schein is the world’s largest provider of health care solutions to office-based dental and medical practitio
Slide 36: Company Snapshot
Company Snapshot Issued Capital1 Share Price & Volume (September 2023 up to 3 September 2024) For personal use only Lumos Diagnostics Holdings Limited (ASX:LDX) - Volume Lumos Diagnostics Holdings Limited (ASX:LDX) - Share Pricing Shares 563.0m $0.11 70.00mm $0.10 60.00mm Options 81.7m $0.09 50.00mm
Slide 37: Board of Directors
Board of Directors For personal use only Sam Lanyon Bronwyn Le Grice Lawrence Mehren Catherine Robson Doug Ward Non-Executive Non-Executive Non-Executive Non-Executive Managing Chair Director Director Director Director & CEO 35
Slide 38: Highly Experienced Leadership Team
Highly Experienced Leadership Team For personal use only Doug Ward Barrie Lambert Sacha Dopheide, PhD Paul Kase CEO & Managing Director Chief Financial Officer Chief Technology Officer SVP of Commercial Operations Doug Ward has more than 30 years of biotech Barrie Lambert has more than 25 years of S
Slide 39: Other Items
For personal use only Other Items
Slide 40: Summary Pro-Forma Balance Sheet
For personal use only Summary Pro-Forma Balance Sheet
Slide 41: Summary Pro-forma Balance Sheet
Summary Pro-forma Balance Sheet 30-Jun-24 Impact of 30-Jun-24 US$ million (Audited) 3 equity raising1,2 Pro-forma For personal use only (US$ million) (US$ million) (US$ million Cash and cash equivalents 6.5 6.3 12.8 Other current assets 3.0 3.0 Total Current Assets 9.5 6.3 15.8 Total Non-Current Ass
Slide 42: Key Risks
For personal use only Key Risks
Slide 43: Key risks
Key risks This section discloses some of the key risks attaching to an investment in Lumos. The Company is subject to risks that are specific to the Company and the Company’s business activities, as well as general risks. Before investing or increasing your investment in Lumos, you should consider w
Slide 44: Key risks cont.
Key risks cont. Reliance on Distributors The success of Lumos’ Products business relies on its ability to attract, retain, support and motivate distributors. The loss of, or any significant decrease in business from these distributors may negatively impact Lumos’ financial performance. For personal
Slide 45: Key risks cont.
Key risks cont. Reimbursement and coverage Third-party payers, whether U.S. or non-U.S., or governmental or commercial, are developing increasingly sophisticated methods of controlling rising healthcare costs. These include, evaluating the cost- For personal use only effectiveness and economic impac
Slide 46: Appendix – Underwriting Agreement
For personal use only Appendix – Underwriting Agreement
Slide 47: Underwriting Key Terms
Underwriting Key Terms The Company has entered into an underwriting agreement (Underwriting Agreement) with Bell Potter Securities Limited (Lead Manager) who has agreed to act as lead manager and bookrunner to the Offer and underwriter to the Retail Entitlement Offer up to a maximum aggregate amount
Slide 48: Underwriting Key Terms
Underwriting Key Terms e. (withdrawal) the Company withdraws the Offer or any part of it; For personal use only f. (corrective notice) the Company becomes required to give or gives a correcting notice under subsection 708AA(10) other than as a result of a new circumstance arising; g. (market fall) t
Slide 49: Underwriting Key Terms
Underwriting Key Terms o. (adverse change) there is a material adverse effect, or an event occurs which is likely to give rise to a material adverse effect; For personal use only p. (capital structure) the Company alters its capital structure or constitution without the prior written consent of the
Slide 50: Underwriting Key Terms
Underwriting Key Terms g. (breach) the Company fails to perform or observe any of its obligations under the Underwriting Agreement or a representation or warranty is or becomes untrue; For personal use only h. (market or trading disruption) there is: (i) a suspension or material limitation in tradin
Slide 51: Appendix – Foreign Selling Restrictions
For personal use only Appendix – Foreign Selling Restrictions
Slide 52: International Offer Restrictions
International Offer Restrictions Hong Kong For personal use only • WARNING: This document has not been, and will not be, registered as a prospectus under the Companies (Winding Up and Miscellaneous Provisions) Ordinance (Cap. 32) of Hong Kong, nor has it been authorised by the Securities and Futures
Slide 53: Glossary
For personal use only Glossary
Slide 54: Glossary
Glossary • ASIC means the Australian Securities and Investments Commission. For personal use only • ASX means ASX Limited ACN 008 624 691 or the financial market known as the 'Australian Securities • IVD means in vitro diagnostics. Exchange' operated by it, as the context requires. • MDSAP means Med
Slide 55: Contact information
For personal use only Contact information Retail entitlement offer Other queries Shareholders requiring information about the Retail For all other queries, please contact Entitlement Offer may contact the Company Secretary ir@lumosdiagnostics.com Information Line on: +61 3 9087 1598 or email cosec@l
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