Medical Developments International Limited · ASX:MVP
Medical Developments International — Non-Deal Roadshow (July 2020)
18 slides from Medical Developments International's roadshow presentation, Jun 30, 2020
Slide 1: MVP Roadshow Presentation
MVP Roadshow Presentation July 2020
Slide 2: Who we are
Who we are • Pharmaceutical and devices company based in Victoria, Australia • ASX Listed since 2003 (ASX: MVP) • Market Capitalisation - A$440m • 2 Key operating segments – Pharmaceutical and Medical Devices • Also have a significant API development project ongoing in partnership with the CSIRO • G
Slide 3: Penthrox®: A world class opportunity
Penthrox® A world class opportunity Penthrox® • Market Leader for trauma pain • Opiate sparing, fast-acting inhalational analgesic 1 • 85% of patients reach clinical analgesia within 6-10 breaths • Is a solution to a significant unmet clinical need • Demonstrated safety and efficacy profile for 30+
Slide 4: 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 5: Penthrox® in USA
Penthrox® in USA FDA Update With FDA for review: • Pre-Clinical protocol which mimics human dosing regimen • CRO ready to commence trial once FDA response received • Responses to device questions Human Factors study protocol – ready to commence Completion of PASS in Europe – awaiting final Clinical
Slide 6: Penthrox® in USA
Penthrox® in USA 2017 2018 2019 2020 2021 2022 2023 2024 2025 IND Toxicology: Phase I PK Study Non-clinical - 2 by 14 Day Repeat Europe Studies Dose rat and dog studies - General validation Launch in USA and assay studies to Phase I IND FDA Phase II/III US IND Study Human support existing data submi
Slide 7: Penthrox® in China
Penthrox® in China MVP concluded a significant transaction with Daiichi Sankyo for the Chinese, Thai and Vietnamese markets in 2018. MVP received an upfront payment of circa $21m for the commercialisation rights The China IND was approved in November 2019 • Phase I PK • Phase III Bridging Trauma • P
Slide 8: Penthrox® in China
Penthrox® in China 2018 2019 2020 2021 2022 2023 2024 Received $22m from Daiichi Sankyo. Regulatory and Clinical experts appointed Regulatory Dossier preparation, review and translation IND IND Phase I Dose ranging submission to File NDA with approval Healthy Volunteer Study Chinese FDA Chinese FDA
Slide 9: Financial Performance – H1 FY20
Financial Performance – H1 FY20 Penthrox® Sales in Australia • In market” sales in Australia grew 18% • New Mundipharma distribution agreement delivering strong sales growth in Australia particularly in GP/hospitals • Sales for Australian ‘Dr’s Bags’ up 54% 9
Slide 10: Financial Performance – H1 FY20
Financial Performance – H1 FY20 Penthrox® Sales in Europe • UK in-market sales grew 42% • 131 hospitals using in the UK • Additional ambulance services targeted • In-market European sales grew 35% • 386 customers in France • Launched in Italy, Nordics, Switzerland • A number of major countries in Eu
Slide 11: Continuous Flow
Continuous Flow Our own API - Methoxyflurane Benefits of methoxyflurane manufacture under Continuous Flow vs Batch Process 1. Better overall process control • 40% better reaction conversion • 90% better overall yield conversion • Significantly reduced impurity profile 2. Fast scale-up capability • I
Slide 12: Continuous Flow
Continuous Flow Future API technologies 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 • DICLOFENAC: Estimated USD $6.0 billion global sales
Slide 13: Continuous Flow
Continuous Flow Our Continuous Flow technology delivers: • Increased yields – through 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 • Less carbon footprint “
Slide 14: Global Respiratory – H1 FY20
Global Respiratory – H1 FY20 Global Respiratory Sales Overall • Global sales grew 49% • Improved European sales • Canada sales grew 207% - strong cardboard spacer sales Australia • Sales growth in Australia of 44% • Breath-A-Tech sales grew 31% 14
Slide 15: Respiratory - USA
Respiratory - USA Respiratory Sales in USA • Sales to USA grew 49% - now ranged in over 20,000 pharmacies • Walgreens launched into 4,750 stores in Feb • Private label launch into over 4,500 Walmart stores expected in Aug 2020 15
Slide 16: Outlook
Outlook MVP’s ambition is to globalise Penthrox, and in doing so, make it the mainstream analgesic of choice around the world. This process has begun. Over the next 12 months+ we expect to:- • begin selling Penthrox into numerous new markets – New EU launches, Thailand, Mexico, etc; • Continued expa
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’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other
Slide 18: Medical Developments International
Medical Developments International
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