Medical Developments International Limited · ASX:MVP
Medical Developments International — Non-Deal Roadshow (September 2020)
24 slides from Medical Developments International's roadshow presentation, Sep 1, 2020
Slide 1: MVP Roadshow Presentation
For personal use only MVP Roadshow Presentation September 2020
Slide 2: 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 3: Penthrox Global
Penthrox® Global For personal use only MVP continues to negotiate with interested parties in regards to selling Penthrox, whilst concurrently pursuing other important international regulatory submissions and preparations in countries including USA, China, Russia and South Korea. 3
Slide 4: Penthrox in USA: FDA Update
Penthrox® in USA FDA Update For personal use only Pre Clinical Human Factors Device Clinical • FDA has responded to • MDI has received FDA • Device testing • MDI has submitted a MDI regarding the pre- feedback on Human underway to satisfy request for an FDA clinical protocol, which Factors Study FDA
Slide 5: Penthrox in USA timeline
Penthrox® in USA For personal use only 2017 2018 2019 2020 2021 2022 2023 2024 2025 IND Toxicology: Phase I PK Study Response - 2 by 14 Day Repeat Europe to clinical Dose rat and dog studies question Non-clinical - General validation Studies Launch in USA and assay studies to Phase I IND FDA Phase I
Slide 6: Penthrox in China
Penthrox® in China For personal use only 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
Slide 7: Penthrox in China timeline
Penthrox® in China For personal use only 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 Ch
Slide 8: Penthrox in Europe: Growing through geographic expansion
Penthrox® in Europe Growing through geographic expansion For personal use only • Buyback of EU distribution rights • 27 countries • Booking of sales revenue from September 1st as part of a 6-month transition process • Focus on commercialisation and expansion of the Penthrox® footprint in Europe: • L
Slide 9: Europe phases for a successful market expansion
Penthrox® in Europe 5 phases for a successful market expansion For personal use only Phase I • Transfer of MA from Mundipharma to MVP, whilst securing current positive sales evolutions Phase II • Analysis of the critical success factors to grow the Penthrox® business once the commercial activities c
Slide 10: Penthrox in Europe timeline
Penthrox® in Europe For personal use only 3Q 2020 4Q 2020 1Q 2021 2Q 2021 3Q 2021 4Q 2021 Termination contract signed MA transition to MVP Assessment of country specific requirements (sales, marketing, market access, medical, regulatory, etc) Start commercial activities/set up of infrastructure in c
Slide 11: Financial Performance – FY20
Financial Performance – FY20 Overall FY20 Result GROSS REVENUE p 11% INCREASE TO $23.6M For personal use only $ • Overall gross revenue grew to a record $23.6m 23,700,000 22,200,000 • Gross Margins remain strong 20,700,000 19,200,000 • $15.5m cash 17,700,000 FY18 FY19 FY20 Penthrox® Sales in Austral
Slide 12: Financial Performance – FY20: Penthrox Sales in Europe
Financial Performance – FY20 Penthrox® Sales in Europe For personal use only • UK/Ireland in-market sales grew 23% • 145 hospitals using in the UK • Additional ambulance services targeted • In-market European sales grew 15% • 386 customers in France • Launched in Italy, Nordics, Switzerland • A numb
Slide 13: Global Respiratory – FY20
Global Respiratory – FY20 Global Respiratory Sales For personal use only RESPIRATORY DEVICES p 61% TOTAL GROSS SALES Overall $ • Global sales grew 61% - new launches, 10,000,000 channel growth and COVID-19 driven 9,000,000 8,000,000 • Improved UK/European sales – new 7,000,000 distributor signed in
Slide 14: Respiratory - USA
Respiratory - USA Respiratory Sales in USA For personal use only • Sales to the USA grew 98% - now ranged in close to 21,000 pharmacies • Launched into 4,750 Walgreens stores in Feb 2020 • Private label launch into over 4,500 Walmart stores in Aug 2020 14
Slide 15: Continuous Flow
Continuous Flow Our Continuous Flow technology delivers: For personal use only • 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 • L
Slide 16: Continuous Flow: Future API technologies
Continuous Flow Future API technologies For personal use only MDI continues to develop several key Generic APIs using its continuous flow technology Program is being run under the following Development pathway: Stage 1 – Target Selection Stage 2 – Lab Scale Proof of Concept - Desktop assessment & fe
Slide 17: Continuous Flow: API updates (Lidocaine, Mesalamine)
Continuous Flow Future API technologies For personal use only API in CF Updates: Lidocaine (late Stage 3) – Local Anaesthetic / Analgesic • Successfully run process at 50kg/day to produce Lidocaine USP • Process in line with a ~25% reduction in cost of generic commercial batch process • Challenge in
Slide 18: Continuous Flow: API updates (Leflunomide, Celecoxib, Diclofenac)
Continuous Flow Future API technologies For personal use only API in CF Updates: Leflunomide (early Stage 3) – Anti-Rheumatic / Arthritis • Process validated on small scale continuous flow • Process can potentially make both Leflunomide & Teriflunomide APIs Celecoxib (mid Stage 2) – Non-Steroidal An
Slide 19: New Penthrox Inhaler Selfie
New Penthrox® Inhaler Selfie For personal use only 19
Slide 20: New Penthrox Inhaler Selfie
New Penthrox® Inhaler Selfie 3 components combined For personal use only into 1: • 3ml Penthrox • Inhaler Ready for patient • AC Chamber2 Click ’n’ Go functionality. Faster time to patient = faster time to pain relief. Equivalent clinical performance to current ‘Green Whistle’. 20
Slide 21: Outlook 2020 – 2021
Outlook 2020 – 2021 For personal use only MVP’s ambition is to replicate the domestic success in analgesia and respiratory internationally, whilst capturing a greater share of the full margin on sales. Over the next 12 months+ we expect to: • Continue the Growth and Learning in our Domestic Market w
Slide 22: Global Potential
Global Potential Example of Available ‘Trauma’ Market Based On Current Domestic Success in Global Developed Healthcare For personal use only Markets Penthrox Australia – population 25 million - $8 million sales UK and Republic of Ireland – population 73 million - $23 million European Union – populat
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’, For personal use only ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discu
Slide 24: Medical Developments International
For personal use only Medical Developments International
Medical Developments International — Non-Deal Roadshow (September 2020) on 6ix