Medical Developments International Limited · ASX:MVP
Medical Developments International — Investor Presentation (September 2019)
18 slides from Medical Developments International's investor presentation, Sep 5, 2019
Slide 1: Medical Developments International
For personal use only Medical Developments International September 2019
Slide 2: Key Achievements for FY19
Key Achievements for FY19 For personal use only 2
Slide 3: Key Achievements for FY19
Key Achievements for FY19 For personal use only 3
Slide 4: Key Achievements for FY19
Key Achievements for FY19 For personal use only 4
Slide 5: Future for Penthrox
Future for Penthrox® og od aa 2017 aap oP 2016 Australia ee 2015 Australia UK 323 2014 = Austaia UK jee a = 2" Australia New Zealand New Zealand Singopore i 2010 Austria New Zeeland Singapore Singapore felons ‘2002 2009 ‘Australia New Zealand Moldova Moldova ireland South Aca oe ‘Austole ‘Austral Ne
Slide 6: Penthrox in USA
Penthrox® in USA For personal use only 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 quest
Slide 7: Penthrox in USA
Penthrox® in USA For personal use only 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 s
Slide 8: Penthrox in China
Penthrox® in China For personal use only IND submitted and validation process has begun MVP has received questions and the IND approval is expected during October MVP beginning site selections and protocol training for the hospitals, sites and support organisations like labs to participate • Phase I
Slide 9: Penthrox in China
Penthrox® in China For personal use only 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 Chin
Slide 10: Clinical Trial Pipeline
Clinical Trial Pipeline For personal use only 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
Slide 11: Penthrox in Europe
Penthrox in Europe For personal use only “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 11
Slide 12: Penthrox Rest of World
Penthrox Rest of World For personal use only “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 12
Slide 13: Respiratory devices
Respiratory devices For personal use only 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 cont
Slide 14: Continuous Flow technology
Continuous Flow technology For personal use only Our CF technology has the potential to reduce the cost of API manufacturing compared to batch processing We are working to develop 100kg of Lidocaine Sulphate. We have commenced marketing our CF Lidocaine technology to global manufacturers and we are
Slide 15: Financial Performance
Financial Performance For personal use only 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 1
Slide 16: Outlook
Outlook For personal use only 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 16
Slide 17: Disclaimer
Disclaimer This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, For personal use only ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discu
Slide 18: Medical Developments International
For personal use only Medical Developments International
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