25 Aug 2021

MVP Investor Presentation

MVP Investor Presentation 2020/21 Results Gordon Naylor, Chair Brent MacGregor, CEO 25 August 2021 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 things, strategy, go als, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward - looking statements contained in this presentation, am ong others: 1. pricing and product initiatives of competitors; 2. legislative and regulatory developments and economic conditions; 3. delay or inability in obtaining regulatory approvals or bringing products to market; 4. fluctuations in currency exchange rates and general financial market conditions; 5. uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without lim itation negative results of clinical trials or research projects, unexpected side - effects of pipeline or marketed products; 6. increased government pricing pressures; 7. interruptions in production; 8. loss or inability to obtain adequate protection for intellectual property rights; 9. litigation; 10. loss of key executives or other employees; and 11. adverse publicity and news coverage. There can be no assurance that any existing or future regulatory filings will satisfy any health authorities’ requirements re gar ding any one or more product candidates, nor can there be any assurance that such product candidates will be approved by any health authorities for sale in any market or that they wil l reach any particular level of sales. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual resu lts may vary materially from those described herein as anticipated, believed, estimated or expected. Medical Development International Limited is providing this information as of t he date of this document and does not assume any obligation to update any forward - looking statements contained in this document as a result of new information, future events or developments or otherwise. Any statements regarding earnings is not a profit forecast and should not be interpreted to mean that Medical Developments In ter national’s earnings for this year or any subsequent period will necessarily match or exceed the historical published earnings of Medical Developments International. Medical Dev elo pments International Limited, its directors, officers and employees do not accept any liability whatsoever for any damage or loss caused by anything contained in this document. For marketed products discussed in this presentation, please see full prescribing information on our website at www.medicaldev.com All mentioned trademarks are legally protected. 2 Disclaimer 3 A transitional year for MVP … with COVID FY21 STATUTORY FINANCIALS $M Gross Revenue 25.7 Gross Margin $ 19.1 Net Profit After Tax (12.6) Cash on hand 36.3 Reclaimed marketing authorisations across Europe, in Australia and began the process in Canada COVID was a serious headwind; but we are seeing recovery signs CEO, Chair and Board changes Successful capital raise Comprehensive review of our Balance Sheet Restructuring the business for global growth 4 Gross Revenue Bridge Europe Penthrox growth despite COVID Overall gross revenue grew 9% over prior year… … with much of this growth from contract income Respiratory sales are lower – COVID - 19 impact with late surge in FY20 buying, a milder cold and flu season and reduced community movement Lower Penthrox sales – exiting distributor sold through stock Modest growth in our Europe Penthrox business despite COVID - 19 impact ? --------------- Operational ----------------- ? 5 EBIT Bridge Reflects the unique features of the year COVID impact on our AU Penthrox and respiratory business Suppressed Penthrox sales in Q2 due to distributor inventory sell - through Modest growth of our Europe Penthrox Result is an underlying EBIT of ($4.4m) $9.0m of Impairments $9.5m of Penthrox EU transition costs Positive impact of non - recurring contract income ? ---------------- Operational ------------------ ? 6 Australian business is recovering from COVID Lockdowns are an ongoing challenge Penthrox Mundipharma Australia sell - through of inventory meant minimal sales for MVP in Q2 Once the sell - in period was over, and MVP in full control, we witnessed a rapid recovery of our business through the end of FY21 Our H2 FY21 sales were the highest ever in - market for a six - month perio d Respiratory COVID - related panic buying in late FY20 led to slow start to FY21, compounded by a depressed market Recovery began in March, driven by anti - static Breath - a - Tech spacer into Chemist Warehouse Upcoming launch of our collapsible spacer into Chemist Warehouse should generate further encouraging signs, but the lockdowns will impact our recovery Improving COVID environment Increased access to hospitals ~14,000 units sold in July, highest ever Launch of Penthrox across Nordic region Distributors are keen to expand territory 7 Penthrox sales showing growth again in Europe, driven by the UK & France 0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 In - market unit sales (3 - month moving average) 8 The UK market is approaching a new threshold Increased growth since May 2020 June saw the highest ever month for UK hospital sales UK passing 6000 unit per month Birmingham Hospital study being marketed as tool to engage key hospitals Both national Pre - and Hospital guidelines now include Penthrox In - market unit sales (3 - month moving average) 0 1000 2000 3000 4000 5000 6000 7000 8000 9 The current trend in France is encouraging 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 4,500 Highest sales since July 2019 Currently 1 Key Account Manager (KAM) since March; 8 more to join in September Principal investigator of seminal French study to train our KAMs Key success factor will be focus! Mundi Promotion No promotion + COVID MVP units Advancing our plans for longer - term growth 10 Following guidance from the FDA in April, we have worked with an advisory group to revise our clinical trial protocol We intend to submit revised protocol to FDA in November ; we expect an answer within 30 days Penthrox – US MVP has achieved ethics approval for its required Pharmaco - kinetic study, with the first patient to be enrolled in Q 4 2021 The two required additional studies, trauma and minor surgical procedure, begin enrolment in early 2022 Penthrox – China Next generation device development Entering final engineering stage of the new device, including an enhanced container closure system Anticipate launch of next gen Penthrox in Australia by FY 24 , with Europe and US to follow one year later Flow technology Lidocaine has successfully advanced to ‘Stage 4 ’ commercial scale production capability We will conduct a strategy review of Flow technology with the Board to determine our desired commercial path forward We are exploring broader indications for Penthrox to expand our addressable market Targets under consideration include expansion to paediatric age, short surgeries pain management, e . g . biopsies Other Penthrox indications 11 We are building a global company Commercial Operations overhaul in Australia, and in Europe Medical Affairs focus to support commercial execution Renewed Human Resources capability Clinical Development accountability and clarity Identify Key decision - making processes and platforms to support global aspiration Further changes in AU; augmentation of Europe team, based on Germany and Italy outcomes Further expansion of Medical Affairs resources in Europe and at global HQ Overhaul of talent management processes Hire of Head of Clinical Development Revamp S&OP, new product development, strategic planning, capital project review, ERP FY21 progress FY22 enhancements MVP is preparing for growth The market potential for Penthrox remains strong The first transformational changes are done … more changes will roll out this year Early signs in France are encouraging … and 8 new KAMs are beginning in September Both of our partners in Europe want to expand their territories We have set aggressive goals for FY22 and beyond Chelsea’s Hakim Ziyech , being treated with the Green Whistle during UEFA Super Cup in Belfast, August 2021
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