Medical Developments International Limited · ASX:MVP
Medical Developments International — Investor Presentation (March 2019)
39 slides from Medical Developments International's investor presentation, Mar 4, 2019
Slide 1: Medical Developments International March 2019
For personal use only Medical Developments International March 2019
Slide 2: 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 3: Vision
Vision For personal use only Medical Developments International (MVP) is a leading Emergency Medicine Company. Our aim is to: 1. Provide unique and innovative products to assist our customers in the management of acute pain, trauma and procedural pain and to be the market leader globally. 2. Provide
Slide 4: Penthrox®
For personal use only Penthrox® 4
Slide 5: Penthrox: A world class opportunity
Penthrox® A world class opportunity For personal use only 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 eff
Slide 6: Penthrox global sales growth
Penthrox® For personal use only Global sales grew 37% Sales in Europe and UK grew 375% Australian ambulance sales grew 18% 6
Slide 7: European Expansion Plans
Penthrox ® European Expansion Plans Europe launch plan For personal use only In addition to the UK, Ireland, France and Mar-22 Belgium, MVP has launched Penthrox in Sep-21 9 of the 37 countries recently approved Mar-21 (or in the process of approval) Sep-20 Mar-20 MVP still has another 28 countries
Slide 8: Rest of World Expansion Plans
Penthrox® Rest of World Expansion Plans For personal use only In addition to the 37 countries in Rest Of the World launch plan Europe, MVP is working towards Feb-22 approval and to launch Penthrox in Jul-21 Jan-21 another 22 countries including Jun-20 China, Russia and the USA1 Dec-19 May-19 Oct-18
Slide 9: Penthrox global expansion plans
Penthrox® Penthrox global expansion plans For personal use only 9
Slide 10: UK and Ireland update
Penthrox® UK and Ireland update For personal use only “In market” sales in the UK grew 96% in the current half UK & Ireland year compared to the first half of 2018. 500 460 “In market” sales in Ireland grew 30% in H2 of 2018 vs 450 400 384 H1 of 2018. 350 300 288 Focus has shifted from developing Ho
Slide 11: UK and Ireland Ambulance Service Updates
Penthrox ® UK and Ireland Ambulance Service Updates For personal use only Ambulance Service Updates Status Expected Launch National Ireland Ambulance Service Approved (using) ✓ East of England Ambulance Service Approved Q4FY19 Scottish Ambulance Service Approved (selective use) ✓ Yorkshire Ambulance
Slide 12: Europe
Penthrox® Europe For personal use only Our partner is making excellent progress in Europe. In market sales in France grew 108% H1FY19 v H1FY18. Including UK, Ireland, France and Belgium, sales have been made into 13 of the 41 countries in Europe. Launch activities are planned for the remaining 28 co
Slide 13: St Mary's Major Trauma Centre, London
Penthrox ® St Mary’s Major Trauma Centre, London For personal use only Penthrox v. Standard of Care (120 patients). The study has been completed and should be published by the end of the year. In November 2018, an interim analysis of 35 patients was conducted. The interim analysis showed • A reducti
Slide 14: China Update
Penthrox® China Update For personal use only MVP concluded a significant transaction with Daiichi Sankyo for the China, Thailand and Vietnamese markets. MVP received an upfront payment of circa $21m for the commercialisation rights. There is an additional USD $17.5m to be paid subject to performance
Slide 15: Penthrox clinical program for China
Penthrox® Penthrox® clinical program for 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 su
Slide 16: USA Update
Penthrox® USA Update For personal use only MVP expect to submit a Type A meeting request to the FDA during Q4FY19. MVP expect to meet with the FDA during Q4FY19. The purpose of that meeting will be to discuss MVP’s Clinical and Non-Clinical response to the FDA “Clinical Hold” issued in August 2018.
Slide 17: USA Update timeline
Penthrox® USA Update For personal use only 2017 2018 2019 2020 2021 2022 IND Toxicology: - 2 by 14 Day Repeat Dose Phase III to support existing rat and dog studies Phase III studies and data Phase I Dose ranging - General validation and NDA submission Healthy Volunteer Study assay studies to suppor
Slide 18: Clinical Program
Penthrox® Clinical Program For personal use only MVP continues to invest heavily in developing the clinical profile and indications for use of Penthrox. The purpose of our clinical program is to expand the indications for Penthrox and accelerate the adoption of Penthrox globally. Our FY19 investment
Slide 19: Clinical Trial Pipeline
Penthrox ® 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-h
Slide 20: Outlook
Penthrox® Outlook For personal use only 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 another 31 countries; • conclude additional dis
Slide 21: Respiratory and Medical Devices
For personal use only Respiratory and Medical Devices 21
Slide 22: Respiratory Division H1FY19
Respiratory Division H1FY19 For personal use only The first half of FY19 delivered the following results:- • Overall respiratory device sales were up 6% • Sales into the USA grew 136% • Sales into Asia grew 297% • Sales of Breath-A-Tech in Australia grew 11% • Sales into the UK fell 61%. We believe
Slide 23: Respiratory Devices USA
Respiratory Devices USA For personal use only We have access to over 17,000 pharmacies in the USA. There are approximately 65,000 pharmacies in the USA. The response to our product offering in the USA has been excellent and we are working on additional pharmacy chain deals. We are now adding focus t
Slide 24: Respiratory Devices Outlook
Respiratory Devices Outlook For personal use only MVP’s ambition is to globalise the sales of its Respiratory Devices. That process has begun. We already have partners and make sales in 26 countries. Over the next 12 months we expect to:- • obtain additional partnership deals in the USA and deliver
Slide 25: Continuous Flow: A new way to manufacture API
For personal use only Continuous Flow A new way to manufacture API
Slide 26: Global breakthrough in API manufacturing technology
Global breakthrough in API manufacturing technology For personal use only 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
Slide 27: Technology
Technology For personal use only Our CF technology delivers:- • Increased yields • Increased purity • Better control over process • Increased productivity • Lower cost of production • Lower capex • Less manpower • Smaller footprint CF has the potential to reduce the cost of API manufacturing by more
Slide 28: Our own API - Methoxyflurane
Technology Our own API - Methoxyflurane For personal use only 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-
Slide 29: Future API technologies
Technology Future API technologies For personal use only MDI is developing its core flow technology into several generic APIs currently manufactured under standard batch processing. Progress is being made on:- • LIDOCAINE (USP): We have begun the process of looking for a commercial partner for this
Slide 30: Product Development Update
For personal use only Product Development Update
Slide 31: Penthrox Inhaler Developments
Penthrox® Inhaler Developments Selfie Inhaler For personal use only The Penthrox® Selfie inhaler is the next generation of inhalers under development at MDI. It is a fully integrated pain relief system which delivers 3ml of Penthrox® to patients in a quick and easy manner. The Selfie inhaler will be
Slide 32: MVP Corporate
For personal use only MVP Corporate 32
Slide 33: Financial
Financial For personal use only PHARMACEUTICAL MEDICAL DEVICE TOTAL p 37% Total Revenue p 3% p 24% Total Revenue $ $ Total Revenue 6,600,000 3,080,000 $ 6,100,000 3,040,000 5,600,000 3,000,000 9,700,000 5,100,000 2,960,000 4,600,000 2,920,000 HY17 HY18 HY19 9,200,000 HY17 HY18 HY19 8,700,000 VETERIN
Slide 34: Financial
Financial For personal use only EBITDA CASH RESERVES p 47% INCREASE TO $1.1M OPERATING EXPENSES TO REVENUE p INCREASE TO $32.3M $ 1,100,000 $ 64.00% 1,000,000 $ 61.50% 900,000 59.00% 32,500,000 800,000 56.50% 700,000 HY17 HY18 HY19 54.00% HY17 HY18 HY19 24,500,000 16,500,000 EBITDA TO REVENUE $ 15.0
Slide 35: Financial Summary: Breakdown of sales revenue
Financial Summary Breakdown of sales revenue For personal use only Geographical Sales Revenue - FY19 Geographical Sales Revenue - FY18 Middle North Other, 3% East, 0% America, 3% Middle East, 4% Other, 8% NZ, 6% UK/EU, 25% UK/EU, 26% North… NZ, 5% Australia, 50% Australia, 62% UK/EU Australia NZ Nor
Slide 36: MDI Investor Dashboard
MDI Investor Dashboard (ASX: MVP) For personal use only Historical Stock Chart (3yr) Current Stock Price ▲ 0.020 (5.051%) 4.16 27 Feb, 2:52pm Day High 4.390 Day Low 4.100 Open 4.100 Prev. Close 3.960 Avg. Volume 90,002 52 Wk. High 8.000 (13 Mar 2018) 52 Wk. Low 3.480 (15 Feb 2019) Mkt. Cap 258.99 (M
Slide 37: MVP Corporate Overview
MVP Corporate Overview For personal use only David Williams Leon Hoare Max Johnston Phillip Powell Non-Executive Non-Executive Non-Executive Chairman Non-Executive Director Director Director The Managing Director Recent MD of J&J Asia A Chartered of Kidder Williams Ltd, Recent Managing Pacific. A No
Slide 38: Contact Details
Contact Details For personal use only HEAD OFFICE 4 Caribbean Drive Scoresby, Victoria, Australia, 3179 Tel: +61 3 9547 1888 Fax: +61 3 9547 0262 Web: www.medicaldev.com 38
Slide 39: For personal use only
For personal use only 0817 Medical Developments International
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