Medical Developments International Limited · ASX:MVP
Medical Developments International — Investor Presentation (September 2018)
42 slides from Medical Developments International's investor presentation, Sep 10, 2018
Slide 1: Medical Developments International September 2018
For personal use only Medical Developments International September 2018
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 is gaining global acceptance
Penthrox® Penthrox is gaining global acceptance For personal use only Penthrox is currently registered in more than 30 countries and is expected to be sold into approximately 70 countries over the coming years. Approved in 25 countries Expected regulatory approvals in the last 2 years: in FY19 and F
Slide 6: Roll out in Europe commenced
Penthrox® Roll out in Europe commenced For personal use only Including France, Belgium, UK and Ireland, we have 26 new European countries approved to sell Penthrox. We expect Regulatory Approvals for an additional 5 countries worldwide during FY19. Sales orders for 12 countries received. Sales order
Slide 7: Regulatory approval for Penthrox in the rest of World
Penthrox® Regulatory approval for Penthrox in the rest of World For personal use only 7
Slide 8: UK and Ireland update
Penthrox® UK and Ireland update For personal use only “In market” sales in the UK and Ireland grew 53% in H2FY18 vs H1FY18. There are 103 hospital formulary approvals. All 103 hospitals are ordering on a regular basis. Penthrox has been sold into 408 hospitals, clinics, ambulance services and pharma
Slide 9: France update
Penthrox® France update For personal use only Our partner is making excellent progress in France. In market sales in France grew 66% Q3FY18. In summary: • 185 formulary applications have been submitted. • 121 formularies have approved Penthrox in France. • 64 formulary applications are pending. • 25
Slide 10: USA Update
Penthrox® USA Update For personal use only MDI submitted an Investigational New Drug (IND) application to the FDA in July 2018. The FDA response was to ask for a Clinical Hold until the following 7 questions were answered. In summary MVP is required to: 1. Identify an appropriate patient population
Slide 11: USA Update
Penthrox® USA Update For personal use only In addition, the FDA has advised of other issues which do not form part of its “Clinical Hold” Statement. The issues to be addressed include: - 1. The inadvertent exposure of methoxyflurane to healthcare professionals. 2. Minor amendments to the labelling s
Slide 12: USA Update
Penthrox® USA Update For personal use only MVP believes it can satisfactorily answer all the FDA queries. • We are currently completing a Phase 1 study in Europe which includes 56 patients across 7 cohorts. This is a bigger and wider study than the one proposed for the FDA. • We are currently comple
Slide 13: Penthrox clinical program for USA
Penthrox® Penthrox® clinical program for USA For personal use only 2017 2018 2019 2020 IND Toxicology: Additional Phase III to - 2 by 14 Day Repeat Dose Phase I Dose ranging support existing Phase III rat and dog studies Healthy Volunteer Study studies and data - General validation and assay studies
Slide 14: 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. Plans have begun for “prescription take home” and “repeat use” studies. The purpose of our clinical program is to accelerate the adoption of Penthr
Slide 15: Clinical Trial Pipeline
Penthrox ® Clinical Trial Pipeline For personal use only Preclinical Phase I Phase II Phase III/b Phase IV ITT Bone Marrow In vitro *PK Study *Colonoscopy * ER cost benefit Biopsy Genotoxicity QT/QTc Pivotal study in ER’s Vital Signs * WA ambulance *Occupational CNS study PK Study *Penthrox v SOC Ex
Slide 16: 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. That process has begun. Over the next 12 months+ we expect to: • sell Penthrox in 37 countries. We expect to make first sales during FY19 for
Slide 17: Respiratory and Medical Devices
For personal use only Respiratory and Medical Devices 17
Slide 18: Respiratory Division
Respiratory Division FY18 For personal use only Sales of Respiratory Devices in the USA grew year on year. Underlying sales “off the shelf” grew strongly. Sales of Respiratory Devices in the UK and Europe grew 35%. Sales of Breath-A-Tech in Australia declined on a comparative basis because there wer
Slide 19: Respiratory Devices: Sold in countries
Respiratory Devices Sold in 26 countries For personal use only Netherlands Switzerland Austria Germany Sweden UK Belgium Ireland Canada Greece Italy Cyprus USA Malta Gibralta Spain Korea Portugal Hong Kong Singapore Malaysia UAE KSA New Zealand Australia Kuwait 19
Slide 20: Respiratory Devices USA
Respiratory Devices USA For personal use only We have access to over 13,000 pharmacies in the USA. We have completed ranging deals with national groups; Walgreens, Walmart, Sam’s Club, Costco and Kmart plus many regional groups. There are approximately over 65,000 pharmacies in the USA. The response
Slide 21: 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 s
Slide 22: Intellectual Property
Intellectual Property For personal use only MVP is protecting its future by generating intellectual property from its manufacturing technology and delivery devices. MVP has filed and is managing the following patents and trademarks: • 7 Penthrox Inhaler patents; • 5 Respiratory patents; • 1 manufact
Slide 23: Continuous Flow: A new way to manufacture API
For personal use only Continuous Flow A new way to manufacture API
Slide 24: 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 25: 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 capacity to reduce the cost of API manufacturing by more
Slide 26: Technology: 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 27: Technology: Methoxyflurane batch vs continuous flow capacity
Technology Our own API - Methoxyflurane For personal use only Batch Process 2000L/pa at existing site (single shift) 4000L/pa at existing site (double shifts + CapEx) >4000L/pa = new manufacturing site + significant CapEx Continuous Flow Process 10,000L/pa at existing site (300 mL CF reactor - singl
Slide 28: 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. Examples of this are: • LIDOCAINE (USP): Estimated USD $3.5 billion global sales • DICHLOFENAC: Estimated USD $6.0 bil
Slide 29: Future API technologies
Technology Future API technologies For personal use only • ISO-/DES-/SEVOFLURANE Significant improvements in handling highly toxic & corrosive Fluoride intermediates under safe flow conditions. Estimated USA $3 billion global sales market • CANNABIDIOL Early stage development in producing CBD in hig
Slide 30: Product Development Update
For personal use only Product Development Update
Slide 31: Penthrox Inhaler Developments: Selfie Inhaler
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: Penthrox Inhaler Developments: Selfie Inhaler
Penthrox® Inhaler Developments Selfie Inhaler For personal use only When pain relief is required the Health Care Professional: • removes the lock out tab then • pushes down the plunger to activate the inhaler • patient then breathes through the mouthpiece Initial testing indicates the methoxyflurane
Slide 33: MVP Corporate
For personal use only MVP Corporate 33
Slide 34: Financial Summary: Summary of Capital Raise
Financial Summary Summary of Capital Raise For personal use only In August 2018 MVP raised $17 million in a placement to institutional investors at $4.00 per share. • 69% went to overseas institutions. • 41% of the issue went to new shareholders. The Shareholder Purchase Plan to issue a maximum of 1
Slide 35: Breakdown of sales revenue
Financial Summary Breakdown of sales revenue For personal use only MVP is still deriving most of its revenue from Australia. That will change beginning FY19. Penthrox Sales Revenue - FY18 Internationa Other Other Penthrox Sales Revenue - FY17 International, 4% l, 1% UK, 3% EU, 2% UK, 5% Middle… Midd
Slide 36: Breakdown of sales revenue
Financial Summary Breakdown of sales revenue For personal use only We expect revenue generated from North America and Europe will become a significant driver for growth. Medical Devices Sales Revenue - Medical Devices Sales Revenue - Asia, 4% FY18 FY17 Asia, 6% North North UK/EU, 21% America, 13% Am
Slide 37: Breakdown of sales revenue
Financial Summary Breakdown of sales revenue For personal use only Geographical Sales Revenue - FY18 Geographical Sales Revenue - FY17 Middle East, 4% Middle East, 5% Other, Other, 7% 5% North America, UK/EU, 16% 5% UK/EU, 18% North… NZ, 6% NZ, 5% Australia, 62% Australia, 60% UK/EU Australia NZ Nor
Slide 38: Financial Summary: Cash
Financial Summary Cash For personal use only For the FY18 Year, MVP made the following cash investments: • $3.7m into USA regulatory program; • $2.5m into other clinical trials and Penthrox regulatory approvals; • $0.9m in a European Phase I PK Study with our partner; • $2.0m into equipment for the
Slide 39: MDI Investor Dashboard
MDI Investor Dashboard (ASX: MVP) For personal use only Historical Stock Chart (3yr) Current Stock Price ▲ 0.110 (2.723%) 4.15 3 Sep, 3:16pm Day High 4.190 Day Low 4.070 Open 4.070 Prev. Close 4.040 Avg. Volume 131,929 52 Wk. High 8.070 (12 Jan 2018) 52 Wk. Low 3.560 (21 Aug 2018) Mkt. Cap 256.23 (M
Slide 40: MVP Corporate Overview
MVP Corporate Overview For personal use only David Williams Dr Harry Oxer Leon Hoare Max Johnston Allan McCallum Phillip Powell Non-Executive Non-Executive Non-Executive Non-Executive Non-Executive Non-Executive Chairman Director Director Director Director Director The Managing Director A Medical Co
Slide 41: 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 41
Slide 42: For personal use only
For personal use only 0817 Medical Developments International
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