Medical Developments International Limited · ASX:MVP
Medical Developments International — Investor Presentation (March 2020)
29 slides from Medical Developments International's investor presentation, Mar 16, 2020
Slide 1: Medical Developments International March 2020
For personal use only Medical Developments International March 2020
Slide 2: Key Achievements: Penthrox
Key Achievements For personal use only Penthrox® → In market sales in the UK grew 42% → Approved for use by UK Military and given a → Australian Penthrox® sales grew 18% NATA number → Australian Penthrox® sales to GPs grew 54% → Progressing USA IND → European sales up 35% → Progressing South Korea a
Slide 3: Key Achievements: Respiratory Medical Devices
Key Achievements For personal use only Respiratory Medical Devices → USA sales grew 49% → Australian sales grew 44% → UK and European sales grew 73% → Global respiratory device sales up 49% 3
Slide 4: Key Achievements: Other
Key Achievements For personal use only Other → New 5-year agreement with CSIRO for → Received R&D Tax Incentive concession of Continuous Flow technology $431,000 → Continued investment in clinical development programs and trials 4
Slide 5: Penthrox in USA: FDA Update
Penthrox® in USA FDA Update For personal use only With FDA for review: • Pre-Clinical protocol which mimics human dosing regimen • Human Factors study protocol • Responses to device questions Completion of PASS in Europe – awaiting Clinical Study Report in April 2020 IND submission target H1FY21. NO
Slide 6: 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 Studies - 2 by 14 Day Repeat Europe Dose rat and dog studies - General validation and Human Factors Launch in USA Study Phase II/III US IND Study assay studies to Phase I IND FDA s
Slide 7: Penthrox in China
Penthrox® in China For personal use only IND approval November 2019 • Phase I PK • Phase III Bridging Trauma • Phase III Bridging Acute Pain MVP site selections completed and protocol training given to partner Ethics committee submissions on hold due to Coronavirus NDA approval expected 2022 7
Slide 8: 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 Regulatory Dossier preparation, review and translation IND IND submission approval Phase I Dose ranging File NDA with to Chinese Healthy Volunteer Study Chin
Slide 9: Penthrox Clinical: Europe
Penthrox® Clinical For personal use only Europe Paediatric study suspended enrolment due to COVID Other studies suspended enrolment due to COVID 9
Slide 10: Penthrox Publications
Penthrox® Publications MEDITA MEDITA For personal use only Methoxyflurane Sub group analysis provided superior short term pain relief to Methoxyflurane standard analgesic provided superior short treatment (IV morphine, term pain relief IV paracetamol, IV compared to IV ketoprofen) patients morphine
Slide 11: Penthrox Publications
Penthrox® Publications For personal use only Immediate EUSEM Methoxyflurane Penthrox provided superior included as a short term pain first-line option in relief to standard both moderate analgesic and severe pain treatment (mostly while other NSAIDS, analgesics are paracetamol, potentially used opio
Slide 12: Penthrox Clinical Pipeline
Penthrox® Clinical Pipeline For personal use only Preclinical Phase I Phase II Phase III/b Phase IV ITT In vitros *PK Study *ED Bridging study *Real World study * WA ambulance retrospective linkage *Modelling/ *Mountain / hostile Genotoxicity * Penthrox v SoC Retrospective simulation climate rescue
Slide 13: 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 14: Penthrox Future: Europe launch plan
Penthrox® Future Europe launch plan For personal use only Sep-22 Mar-22 Sep-21 Mar-21 Sep-20 Mar-20 Sep-19 Mar-19 Sep-18 Mar-18 Sep-17 Mar-17 MA date In-market launch actual/estimated date 14
Slide 15: Continuous Flow API Manufacturing
Continuous Flow API Manufacturing For personal use only Few companies in the generic pharmaceutical industry are investing in the development of new manufacturing technologies. The single largest development for pharmaceutical markets over the last 30 years has been the introduction of generic manuf
Slide 16: Global breakthrough in API manufacturing technology
Continuous Flow Global breakthrough in API manufacturing technology For personal use only We intend for our Continuous Flow ‘CF’ process API manufacturing technologies to be covered by Patents (applications and pending) or kept as Trade Secrets depending on the market. CF has the capacity to reduce
Slide 17: Continuous Flow technology delivers
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 18: Globally recognised as the future of manufacturing
Continuous Flow Globally recognised as the future of manufacturing For personal use only Statements from Commissioner of Food and Drugs - Food and Drug Administration - Scott Gottlieb M.D. ”One of todays most important tools for modernising the pharmaceutical industry is a process known as continuou
Slide 19: Future API technologies
Continuous Flow 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 • DICLOFENAC: Estimated USD $6.
Slide 20: Lidocaine Continuous Flow deliverables
Continuous Flow Lidocaine Continuous Flow deliverables: For personal use only • Lidocaine (base/HCl) to USP & Ph Eur • Pilot scale capable of producing kilograms/hr (completed) • Commercial scale expected to produce >100kgs per day (under qualification) • Minimal change to footprint from Pilot Plant
Slide 21: Benefits of Lidocaine under Continuous Flow v Batch
Continuous Flow Benefits of Lidocaine manufacture under Continuous Flow v Batch Process For personal use only 1. We expect better overall process control, which will deliver: • A significantly better reaction conversion • Better overall yield conversion • Significantly reduced impurity profile • Sig
Slide 22: Financial Performance: Penthrox Sales in Europe
Financial Performance Penthrox® Sales in Europe For personal use only • UK in-market sales grew 42% • 131 hospitals using in the UK • In-market European sales grew 35% • Launched in Italy • 386 customers in France • A number of major countries in Europe still to launch including Germany and Spain 22
Slide 23: Financial Performance: Penthrox Sales in Australia
Financial Performance Penthrox® Sales in Australia For personal use only • 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% 23
Slide 24: Financial Performance: Global Respiratory Sales
Financial Performance Global Respiratory Sales For personal use only 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% 24
Slide 25: Financial Performance: Respiratory Sales in USA
Financial Performance Respiratory Sales in USA For personal use only USA • Sales to USA grew 49% • Walgreens launched into 4,750 stores in Feb • Private label launch into over 4,500 Walmart stores expected in H2 FY20 25
Slide 26: Financial Performance
Financial Performance For personal use only Gross Revenue increased 15% to $11.2m EBITDA Gross EBITDA increased 21% $1.5m Profit $7.3m Net Profit after Tax increased 82% Fully Franked interim ordinary dividends of 2.0 $3.5m cps invested $23.2m into Cash Penthrox 26
Slide 27: Outlook
Penthrox® Future Outlook For personal use only Strong sales growth across Penthrox and Respiratory Devices. Regulatory approvals for development program in China, USA and Russia. Commercialisation of first Continuous Flow technology for Lidocaine. 27
Slide 28: 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 29: Medical Developments International
For personal use only Medical Developments International
Medical Developments International — Investor Presentation (March 2020) on 6ix