Medical Developments International Limited · ASX:MVP
Medical Developments International — Non-Deal Roadshow (October 2019)
24 slides from Medical Developments International's roadshow presentation, Oct 30, 2019
Slide 1: Medical Developments International
Medical Developments International October 2019
Slide 2: Key Achievements for FY19
Key Achievements for FY19 Sales in Europe grew 401% > 159 new customers in the rest of Europe Sales into the UK grew 68% > 540 customers in the UK and Ireland (FY18: 385) Global sales grew 47% > Signed exclusive Penthrox® deal for China and Sales to Australian Ambulance grew 38% received A$20.8m upf
Slide 3: Key Achievements for FY19
Key Achievements for FY19 Respiratory Medical Devices > Sales into the USA grew 62% > Australian Breath-A-Tech sales up 9% >> Sales in Asia up 111% > UK/EU sales down 53% ‘Medical Developments International
Slide 4: Key Achievements for FY19
Key Achievements for FY19 Ot > Raised $24.5m via Institutional Placement and > Received R&D Tax Incentive concession of Share Purchase Plan $488,000 > CSIRO development project for new manufacturing > Repayment of all bank debt technologies progressing > Continued investment in clinical development
Slide 5: Penthrox®
Penthrox® • Market Leader for trauma pain and minor surgical procedures • Opiate sparing, fast acting inhalational analgesic 1 • 85% of patients reach clinical analgesia within 6-10 breaths • A solution to a significant unmet clinical need and clinical evidence proving superior to IV morphine and ot
Slide 6: Future for Penthrox®
Future for Penthrox® ao Bem aan 2017 cont ae 7 2016 Australia Pate . ae UK ma gale a iG ol 2 Australia Now Zealand Now Zealand. £722® New Zealand se 2010 Australia New Zealand Singapore Singapore i Seowpoe 2002 2009 Australia New Zeeland Moldova Moldova. reland South Afica ——SauhAica te Austraia ‘Au
Slide 7: Penthrox in Europe
Penthrox in Europe “In market” sales in • UK grew 86% • France grew 55% • Europe grew 401% • Customer numbers grew 65% • Most major countries in Europe still to launch including Germany, Italy and Spain 7
Slide 8: Penthrox Rest of World
Penthrox Rest of World “In market” sales in • Australia grew 32% • Australian Ambulance grew 38% • Customer numbers grew 65% • New Mundipharma distribution agreement expected to deliver strong sales growth in Australia 8
Slide 9: Penthrox® in USA
Penthrox® in USA Clarity from the FDA Concession from the FDA on required animal studies Clear pathway forward to open IND • One pre-clinical study which mimics human dosing regimen in animals • One Human Factors Study • Completion of PASS in Europe • Complete answers to questions on Penthrox device
Slide 10: Penthrox® in USA
Penthrox® in USA 2017 2018 2019 2020 2021 2022 2023 IND Toxicology: Phase I PK Study Non clinical - 2 by 14 Day Repeat Europe Studies Dose rat and dog studies - General validation and Human Factors Launch Study Phase II/III US IND Study assay studies to In USA Phase I IND FDA support existing data s
Slide 11: Penthrox® in China
Penthrox® in China IND submitted and validation process has begun MVP has received questions and the IND approval is expected during 2019 MVP beginning site selections and protocol training for the hospitals, sites and support organisations like labs to participate • Phase I PK • Phase III Bridging
Slide 12: Penthrox® in China
Penthrox® in China 2018 2019 2020 2021 2022 Received $22m from Daiichi Sankyo. Regulatory and Clinical experts appointed Phase I Dose ranging Healthy Volunteer Study in China Regulatory Dossier preparation, review File NDA with and translation IND submission Chinese FDA to Chinese FDA CFDA Approval
Slide 13: Clinical Trial Pipeline
Clinical Trial Pipeline Preclinical Phase I Phase II Phase III/b Phase IV ITT In vitros PK Study *Wound *Real World study * Penthrox v SOC Management vs LA Modelling / *Mountain / harsh Hospital Outcomes Genotoxicity simulation *Bridging study climate rescue of pre-hospital CNS study *PK Study *Air
Slide 14: Respiratory devices
Respiratory devices MVP offers a range of devices that can be used to help patients manage and take control of their asthma and COPD. • Space Chamber PlusTM anti-static spacer range • Space Chamber PlusTM spacer • Space ChamberTM Autoclavable • Compact Spacer Chamber PlusTM • Space Chamber SlimTM •
Slide 15: Respiratory devices
Respiratory devices USA • Sales to USA grew 62% Strong growth expected in FY20 • Pilot program with 200 CVS stores and own label Walmart launch expected FY20 Other • Global sales down 5% but due almost entirely to UK issue • Strong sales growth in Asia which is expected to continue 15
Slide 16: Continuous Flow technology
Continuous Flow technology Medical Developments International (MDI) has worked with Australia’s Commonwealth Scientific & Industrial Research Organisation “CSIRO” for almost 10 years on this project. CSIRO is a world leading scientific academy backed by the Australian governments with approximately
Slide 17: Continuous Flow technology
Continuous Flow technology Our Continuous Flow technology delivers:- • Increased yields – though better process conversion • Increased purity – through better process control • Better control over entire process – test in real time • Lower cost of production • Lower capex • Less waste • Smaller foot
Slide 18: Continuous Flow technology
Continuous Flow technology Benefits of Continuous Flow vs Batch Process for Penthrox 1. Better overall process control • 40% better reaction conversion • 90% better overall yield conversion • Significantly reduced impurity profile 2. Fast scale-up capability • Increase output up x10+ on same footpri
Slide 19: Continuous Flow technology
Continuous Flow technology MDI is developing its core flow technology into several generic APIs currently manufactured under standard batch processing. Examples of this are: • LIDOCAINE (USP): Estimated USD $3.5 billion global sales • DICHLOFENAC: Estimated USD $6.0 billion global sales • SALBUTAMOL
Slide 20: Continuous Flow technology
Continuous Flow technology Lidocaine update • Lidocaine (base/HCl) produced at >99.9% purity – meets USP42 & EP8.0 • Pilot scale capable of producing kilograms/hr (completed) • Commercial scale expected to produce >100kgs per day (under qualification) • Minimal change to footprint from Pilot Plant t
Slide 21: Financial Performance
Financial Performance Cash receipts were $62.2m $25.6m (including capital raise and China deal) EBITDA Net $3.4m Cash Nil debt Net Profit after Tax increased 327% $6.8m Gross EBITDA increased 55% invested Profit into $14.2m Penthrox Fully Franked ordinary dividends of 4.0 cps 21
Slide 22: Outlook
Outlook Strong sales growth across Penthrox and Respiratory Devices Regulatory approvals for development program in China and USA and Russia Commercialisation of first Continuous Flow technology for Lidocaine 22
Slide 23: Disclaimer
Disclaimer This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other
Slide 24: Medical Developments International
Medical Developments International
Medical Developments International — Non-Deal Roadshow (October 2019) on 6ix