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Annual Report 2024

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1 Financial Year ended 30 June 2024 ANNUAL REPORT 2 1 On behalf of the Board of Directors of Medical Developments International, I am pleased to present the Annual Report for the year ended 30 June 2024. The Report highlights the positive momentum we have achieved in our financial performance as well as progression of our strategy. Despite falling short of our expectations, the Company delivered strong financial improvements in FY24. The Company undertook a successful $10 million capital raise to support the acceleration of specific mid-term growth objectives and to secure the Balance Sheet. The Company is making good progress toward cashflow positivity. We expect to see further growth in FY25 as the changes that Brent and his team have implemented take effect. On behalf of the Board, I would like to recognise the efforts of all employees as the company moves toward financial sustainability. I especially thank Brent for his leadership in navigating difficult circumstances. I would also like to thank our shareholders for their continued investment in the Group. We are very encouraged by our progress in FY24 and look forward to continued momentum in the year ahead. Gordon Naylor Company Chair Message from the Company Chair Contents Overview Message from the Company Chair 1 Message from the CEO 2 Company Overview 4 FY24 Highlights 7 Review of Operations and Financial Performance 8 Financial Reports 20 Directors’ Report 22 Remuneration Report 27 Auditors Independence Declaration 43 Independent Auditor’s Report 44 Financial Statements 50 Directors’ Declaration 86 Shareholder information 87 2 3 Message from the CEO Brent MacGregor Chief Executive Officer The Group delivered strongly improved financial results in FY24, reflecting efforts across the organisation to grow volume, improve margins, reduce costs, and deliver operational improvements. While we delivered good progress, we did fall short of achieving our revenue aspirations in the year. A longer than expected sales cycle for Penthrox in the Australian hospital segment, and seasonal demand softness in the Australian respiratory market, resulted in lower volumes than planned. Notwithstanding these challenges, we remain confident in the long-term growth opportunities of our lead products and are encouraged by the positive momentum we have achieved. FY24 performance Group revenue grew to $33.2 million, up 3% on the prior year. Pain Management segment revenue grew 4% to $21.3 million. Revenue in Australia was up 28%, with strongly improved pricing and volume growth, driven by increased Penthrox penetration in hospital emergency departments. Revenue in Europe was up 11% with strong demand from the Nordic region and continued growth momentum in the UK. Demand in France also improved despite the removal of promotional activity in FY24. Revenue from other markets was down 41%, driven primarily by inventory stocking for the relaunch of Penthrox in Canada in the prior year. Revenue in the Respiratory segment was up 1% at $11.9 million. US revenues were up 37%, reflecting continued strong market share gains in our target growth market. In Australia, our leading market share was maintained despite revenue being down 18% due to the lower prevalence of respiratory conditions in the period. Revenue in Europe was down 44% due to the impact of inventory stocking in the prior year. Improved pricing and operational efficiency delivered $7.2 million in earnings benefits. Gross margins were strongly improved, up 5ppts to 74%. Higher revenues, improved margins and lower costs delivered a $6.6 million improvement to Underlying EBIT. Free cashflow improved by $10.2 million, with enhanced earnings, disciplined working capital management, and lower capital expenditure. In August 2024 we successfully completed a $10 million capital raise. Our Balance Sheet is strong with funding capacity to accelerate delivery of our strategy. Strategy The Group’s near-term strategic focus is to increase the penetration of Penthrox in existing markets, and to continue to grow its Respiratory segment through market share gains, particularly in the US. Longer term, the Group seeks to enter new and attractive markets for Penthrox, including the US. The Group made good progress in its strategy in FY24, advancing the following key priorities: 1. Improve margins through pricing and efficiency Higher Penthrox pricing and efficiency benefits delivered a gross margin improvement of five percentage points and a reduction in costs of $5 million in the year. Operational efficiency initiatives that were implemented in FY24 will drive a further $3-4 million reduction in costs in FY25. 2. Increase penetration of Penthrox in Australian hospital emergency departments In Australia, Penthrox was listed on protocols in 44 new hospitals, and the total number of purchasing hospitals increased by 68 over the last year, to 244 hospitals. In the period, Penthrox was also listed on the South Australian state formulary for use in emergency departments. Volume in the hospital segment grew by ~30%, however the strong lead indicators are yet to be fully reflected in volume growth due to a longer than expected sales cycle. Our learnings to date will inform our commercial and medical engagement activities in the year ahead as we look to accelerate penetration of this large and attractive segment. 3. Grow Penthrox in Europe The Group reported record European annual in-market volumes in FY24, with the Nordic region, France and the UK all performing well. Early in the year we transitioned to a “capital-light” operating model in Europe, driven by scaling back our in- market promotional activity in France which significantly reduced our cost to serve. We have since advanced negotiations with partners for Penthrox distribution in France and in Switzerland. Preparations for submission of the MAGPIE paediatric study data to the European regulatory agency in August 2024 (for select markets) were completed. Future regulatory approval of our submission to reduce the age indication for Penthrox to children >6 years of age would expand the addressable market and could also address a barrier to Penthrox entry into some ambulance trusts in the UK. The UK is our largest existing market for Penthrox outside of Australia. We have extended the agreement for distribution of Penthrox in the UK and Ireland to the end of 2027. The extension delivers improved economic terms for the Group from FY25 and provides a strong foundation to maximise the potential of a broader age indication in these markets from FY26. 4. Continue to grow in the Respiratory segment Our key target growth market in the Respiratory segment remains the US. Here we delivered robust growth for the third consecutive year with revenue in FY24 up 37%. 5. Advance US market entry for Penthrox In October 2023, we had a positive meeting with the US FDA. The meeting provided increased clarity on the clinical pathway to US market entry. From this, we have been able to develop more fully our estimates of project costs and timelines. We announced in April 2024, however, that following further evaluation of resourcing requirements and funding options to progress market entry plans, we would pause the commencement of the next phase of investment in favour of focusing on the underlying business. Aligned with the delayed commencement of further US market entry activity, investment in the Group’s next generation device was also paused. Plans will be recommenced at the appropriate time. We remain confident that an attractive commercial opportunity exists for Penthrox in the US. Sustainability During the year, we undertook an evaluation of how our business practices meet key environmental, social and governance (ESG) standards and expectations. The evaluation will inform development of the Group’s ESG strategy and governance, and preparations for future regulatory changes. Outlook The Group expects positive momentum in margins and earnings to continue in FY25, with underlying EBIT to be strongly improved on FY24, driven by higher average Penthrox prices and operational efficiencies of $3-4 million. Positive operating cashflow is expected to be achieved by the end of FY25. 4 5 Pain Management A world leader in the supply of analgesia for acute trauma and procedural pain The Company manufactures its unique inhaled analgesic, Penthrox® (the “Green Whistle”), at manufacturing facilities at Scoresby and Springvale in Victoria, Australia. Penthrox® is a fast onset, non-opioid analgesic indicated for pain relief by self-administration in patients with trauma and those requiring analgesia for surgical procedures. Penthrox® has been used safely and effectively for more than 40 years in Australia, and is now approved for sale in over 40 countries with approximately 8 million administrations globally. Respiratory A leading supplier of respiratory products to help patients manage asthma and chronic obstructive pulmonary disease (COPD) The Company supplies pharmacies, medical clinics, and hospitals with a range of respiratory devices including space chambers, portable nebulisers and silicon face masks in Australia, the USA, Europe, and Asia, either directly or through partnership with leading distributors. Strategy The Company’s strategic focus is to accelerate penetration of Penthrox® in existing markets, and to grow its Respiratory segment through market share gains. Penthrox® Respiratory Penthrox® & Respiratory Company Overview A leader in acute pain relief and respiratory products Registered in over 40 countries 7 Financial Overview Key Achievements • Underlying EBIT improved $6.6 million (+36%) • Free cashflow improved $10.2 million (+42%) • Gross margin improved by 5ppts, operating costs down ~$5.0 million • Penthrox growth of ~30% in Australian Hospital emergency departments • Record in-market volumes of Penthrox® in Europe • Successful clinical study outcome in children (MAGPIE Study) provides potential to expand addressable market for Penthrox • Extension of agreement for Penthrox distribution in UK and Ireland to end of 2027 on more favourable economic terms • Continued share growth in the attractive US respiratory spacer market • $10 million capital raise completed in August 2024 provides funding to accelerate growth • Positive operating cashflow expected by the end of FY25 FY24 Highlights 6 $33.2m $21.3m $11.9m Underlying Adjustments $21.5m (loss) Underlying EBIT $11.6m (loss) (pcp $18.2m loss) (pcp $10.3m gain) (pcp $5.6m loss) NPAT $41.0m (loss) Pain Management Revenue Respiratory Revenue Revenue +1% +4% +3% 9 8 Review of Operations and Financial Performance OVERVIEW • Revenue(1) up 3% to $33.2 million (pcp $32.3 million). - Pain Management revenue up 4% driven by volume growth in Australia and Europe and improved pricing. - Respiratory revenue up 1%, with strong volume growth in the US offset by lower volume in other regions. • Net loss after tax of $41.0 million (pcp $5.6 million loss). • Underlying EBIT(2) improved by $6.6 million at $11.6 million loss (pcp $18.2 million loss). • Strongly improved margins, driven by pricing and business efficiencies. • Free cash flow(3) improved by $10.2 million. • Continued penetration of Penthrox in global markets: - Record in-market volumes in Europe, up 6% on pcp, with pleasing momentum in the Nordics, continued growth in the UK, and growth in France despite the scale-back of in-market promotional activity. - Volume growth of 3% in Australia, with volume growth of ~30% in the hospital segment and solid demand from ambulance. • Market share growth in the US Respiratory market with US sales up 37%. • Transition to a “capital-light” operating model in Europe completed, with cost to serve significantly reduced. • Successful paediatric clinical study outcome (MAGPIE), provides the potential to expand the addressable market for Penthrox to children in select markets outside of Australia. • Extension of agreement for distribution of Penthrox in the UK / Ireland with improved economic terms. • $10 million capital raise completed in August 2024 provides funding to accelerate growth. • Positive operating cashflow expected by the end of FY25. 10 11 GROUP RESULTS Revenue Revenue for the period of $33.2 million was 3% higher than the pcp. Revenue in the Pain Management segment was up 4% driven by improved pricing, particularly in Australia. European Pain Management revenue was up 11%, with growth in underlying demand of 6%. Revenue for Penthrox in Australia was up 28%,reflecting volume growth of 3% and higher prices. Revenue from Rest of World countries was down 41% mostly due to lower volumes to Canada following inventory stocking for the relaunch of Penthrox in the prior year. Milestone income was $0.2 million (pcp $0.7 million). Revenue in the Respiratory segment was up 1% with strong volume growth in the US, supported by market share gains, offset by lower demand in Australia, due to lower prevalence of respiratory conditions, and lower demand from Europe, following inventory stocking in the prior period. $’000 2024 2023 Change $ Pain Management 21,296 20,448 848 Respiratory 11,853 11,720 133 Other - 169 (169) Revenue1 33,149 32,337 812 Contract termination revenue - 18,928 (18,928) Total 33,149 51,265 (18,116) Note: Underlying EBITDA and Underlying EBIT as defined on page 16-17, are non-IFRS financial measures used by management to assess the performance of the business. Refer to Note 1.1 of the full year consolidated financial report for a reconciliation of Group Underlying EBITDA and Group Underlying EBIT by segment. Underlying EBIT was $11.6 million loss, improved $6.6 million on the pcp ($18.2 million loss). Underlying EBIT benefitted from higher pricing in the Pain Management segment, higher Penthrox volumes in Australia and Europe, share growth in the US Respiratory market, and lower costs, driven by efficiency gains. This offset the impact to earnings of lower Penthrox volumes in Rest of World Markets, lower demand for respiratory products in Australia and Europe, non-capital costs associated with the review of the European operating model and US market entry, and inflationary impacts. Depreciation and amortisation was up by $0.3 million from the pcp. Underlying adjustments before tax were a net $21.5 million loss in the period, including: • Share-based payment expense arising from the cancellation of options as part of the transition to new CEO remuneration arrangements ($5.1 million). This is a non-cash adjustment; no benefit was received by the CEO. • Impairment expense of $16.4 million, including $15.8 million for the impairment of capitalised development costs relating to the US market entry, and a $0.6 million impairment in relation to redundant plant and equipment in the manufacturing operations. Underlying adjustments of $10.3 million gain in the prior period related to: • Contract termination revenue arising from the termination of agreements for the distribution of Penthrox in China ($18.5 million) and other countries where revenue opportunities are not being pursued ($0.4 million). • Impairment of capitalised registration costs following the cessation of market activities in China ($5.7 million), and in other countries where revenue opportunities are not being pursued ($0.9 million). There was also a $0.1 million impairment of patents and trademarks. • Costs to complete a comprehensive commercial market assessment for Penthrox in the US ($1.9 million). $’000 2024 2023 Change $ Pain Management (1,139) (9,716) 8,577 Respiratory 974 1,498 (524) Other4 (8,072) (6,915) (1,157) Underlying EBITDA5 (8,237) (15,133) 6,896 Depreciation and amortisation (3,394) (3,113) (281) Underlying EBIT2 (11,631) (18,246) 6,615 Share-based payment expense arising from the cancellation of options (5,136) - (5,136) Impairment losses - capitalised registration costs (15,804) (6,709) (9,095) Impairment losses - plant & equipment (571) - (571) Contract termination revenue - 18,928 (18,928) Commercial market assessment costs - (1,930) 1,930 Underlying adjustments (21,511) 10,289 (31,800) Reported EBIT (33,142) (7,957) (25,185) Net interest income 216 465 (249) Income tax benefit / (expense) (8,066) 1,883 (9,949) Net loss after tax (40,992) (5,609) (35,383) Operating Performance 12 13 Tax expense in the current period was $8.1 million. Due to uncertainties with respect to the utilisation of tax losses in the future, the Group has derecognised from tax assets tax losses carried forward from prior periods of $13.7 million and has not recognised current year tax losses of $1.3 million as deferred tax assets. Notwithstanding de-recognition for accounting purposes at this time, tax losses remain available to the Group to be utilized against future taxable profits. Net loss after tax for the period was $41.0 million (pcp loss after tax of $5.6 million). Further detail on revenue and earnings in each of the Group’s operating segments is contained in the Review of Operations below. Net cash flows used in operating activities were $10.8 million, $5.7 million lower than the pcp. This reflects an improved underlying EBITDA performance of $6.9 million in the period, partially offset by a $1.3 million increase in working capital and other assets and liabilities utilised. This included one-off payments of $2.7 million for a commercial market assessment of the US completed in FY23 and contract termination costs in France following the scale down in investment at the end of FY23. Excluding these payments, cash utilised in working capital was improved. Commentary relating to the movement in working capital and other assets and liabilities in the period is provided in the Balance Sheet section. Key Items - $’000 2024 2023 Change $ Net cash flows used in operating activities (10,780) (16,495) 5,715 Payments for property, plant and equipment (793) (1,784) 991 Payments for other intangible assets (2,376) (5,881) 3,505 Proceeds from the issue of shares (net of costs) - 28,316 (28,316) Other cashflows (807) (253) (554) Net increase / (decrease) in cash and cash equivalents (14,756) 3,903 (18,659) Cash Flow Net cash flows used in operating activities $’000 2024 2023 Change $ Underlying EBITDA5 (8,237) (15,133) 6,896 Share based payment expense and other non- cash items5 1,127 718 409 Change in trade and other receivables 1,861 (2,870) 4,731 Change in inventory (393) (1,842) 1,449 Change in trade and other payables (5,261) 2,900 (8,161) Change in trade and other working capital (3,793) (1,812) (1,981) Change in other assets and liabilities (93) (733) 640 Interest received 302 560 (258) Interest paid (86) (95) 9 Net cash flows used in operating activities (10,780) (16,495) 5,715 Net cash flows used in investing activities Payments for property, plant and equipment were $0.8 million for the period, a decrease of $1.0 million versus the pcp, primarily relate to the Group’s manufacturing operations. Payments for other intangible assets were $2.4 million for the period, mostly related to trials and market registration activities, including the paediatric clinical study in the UK and market entry activity in the US ($2.1 million), and other intangible assets ($0.3 million). Balance Sheet Key Items - $’000 2024 2023 Change $ Cash 9,735 24,661 (14,926) Trade and other receivables 7,071 8,932 (1,861) Inventories 8,771 8,378 393 Prepayments 565 791 (226) Property plant & equipment 10,162 12,122 (1,960) Intangible assets 22,857 38,317 (15,460) Deferred tax assets - 8,112 (8,112) Total Assets 59,161 101,313 (42,152) Trade and other payables 8,254 14,186 (5,932) Employee benefit provisions 948 1,070 (122) Unearned income 1,920 2,182 (262) Deferred tax liabilities 19 - 19 Lease liabilities 2,286 2,560 (274) Total Liabilities 13,427 19,998 (6,571) Net Assets 45,734 81,315 (35,581) 14 15 REVIEW OF OPERATIONS Pain Management The Pain Management segment is a world leader in the supply of analgesia for acute and procedural pain. The Group manufactures its world leading inhaled analgesic, Penthrox® (the “Green Whistle”), at manufacturing facilities at Scoresby and Springvale in Victoria, Australia. Penthrox is sold into domestic and international markets through distribution partnerships and direct in-market capability. $’000 2024 2023 Change $ Revenue1 21,296 20,448 848 Underlying EBITDA5 (1,139) (9,716) 8,577 Underlying EBIT2 (3,852) (12,299) 8,447 Revenue for Pain Management was up 4% on the pcp at $21.3 million. Revenue in Europe was up 11%. In-market demand in Europe was up 6%, with strongly improved volume in the Nordics and continued momentum in the UK and Ireland. Volume in France was improved despite the scale-back of promotional activity in FY23. Revenue in Australia was up 28%, reflecting volume growth of 3% and higher pricing. Demand from the ambulance segment remained solid. Volumes into hospital emergency departments were up 30%, reflecting progress in the commercial strategy to expand in this segment. Revenue from Rest of World countries was down 41% mostly due to lower volumes to Canada following inventory stocking for the relaunch of Penthrox in the prior year. Underlying EBIT for the period was a $3.9 million loss, improved by $8.4 million on the prior year. Earnings benefited from higher pricing, particularly in Australia, a reduction in the cost-to-serve in Europe following transition to a capital-light operating model, and other business efficiencies. Net change in cash for the period was a $14.9 million decrease. Trade and other receivables decreased by $1.9 million, reflecting timing of customer deliveries and strong collections particularly in relation to large deliveries late in FY23 that were due for collection in the current period. Inventories increased $0.4 million, reflecting growth in the US respiratory business. The decrease in property plant and equipment and intangible assets of $17.4 million includes an impairment of capitalised development costs relating to US market entry, including US market registration costs ($13.9 million) and development costs for the next generation device ($1.9 million), and an impairment of redundant plant and equipment ($0.6 million). Additions were $2.4 million, and depreciation and amortisation was $3.4 million. Net tax asset and liabilities decreased by $8.1 million, driven by the derecognition of prior period tax losses ($13.7 million) due to uncertainties with respect to the utilization of tax losses in the future. Current period tax losses of $1.3 million were also not recognised. The decrease in trade and other payables of $5.9 million reflects the payment of $1.9 million for a comprehensive assessment of the commercial potential for Penthrox in the US, payment for capital expenditure $0.9 million, and $0.8 million for contract termination costs in France following the scale down of investment in the prior period. An additional $2.3 million decrease in trade payables primarily relates to timing differences on inventory purchases and freight. A decrease of $0.3 million in unearned income relates to the amortisation of government grants and milestone income in the period. Unearned income of $1.9 million remaining at the end of the period relates to unamortised income received for the distribution of Penthrox in Vietnam and Thailand, and Government Grants. Respiratory The Respiratory segment is a leading supplier of respiratory products including space chambers, peak flow meters, portable nebulisers and silicone face masks to aid sufferers of asthma and COPD (chronic obstructive pulmonary disease). The Respiratory segment supplies into Australia, the USA, Europe and Asia through partnership with leading distributors. $’000 2024 2023 Change $ Revenue 11,853 11,720 133 Underlying EBITDA5 974 1,498 (524) Underlying EBIT2 762 1,250 (488) Revenue for the Respiratory segment was up 1% at $11.9 million. Revenue in the US was stronger, up 37% on the pcp, reflecting continued growth through market share gain. Revenue in other regions was down, reflecting lower volumes, due in part to the lower prevalence of respiratory conditions during the period, and inventory stocking in Europe in the pcp. Underlying EBIT at $0.8m was $0.5m lower, due to lower volume in Australia and Europe. 16 17 BUSINESS STRATEGY The Group’s nearer term strategic focus is to increase the penetration of Penthrox in existing markets, and to continue to grow its Respiratory segment through market share gains, particularly in the USA. Longer term, the Çompany seeks to enter new and attractive markets for Penthrox, including the US. Execution of strategy in FY24 The Company achieved good progress in delivering its strategic priorities in FY24. Key outcomes include: • Strongly improved margins, delivered through pricing and operational efficiencies. Earnings benefits of $7.2 million were delivered in the period, with additional savings of $3-4 million to be realised in FY25 from initiatives implemented in FY24. • Increased penetration of Penthrox in Australian hospital emergency departments. Volume growth of ~30% was delivered in the hospital segment in the period, with encouraging lead indicators. There have been 44 new protocol listings for Penthrox over the last 18 months, and the total number of purchasing hospitals in FY24 increased by 68 to 244. • Record in-market Penthrox volumes in Europe, delivering 6% growth versus FY23. • Transition to a “capital-light” operating model in Europe, with a significant reduction in the cost to serve. Partner negotiations were advanced for Penthrox distribution in France and in Switzerland. • Extension of the Penthrox distribution agreement for the UK and Ireland, with improved economic terms. • Successful paediatric clinical study outcome (MAGPIE), which provides the potential to expand the addressable market for Penthrox to children in select markets outside of Australia. • Continued market share gains in the attractive US respiratory spacer market. • Positive momentum in earnings and cashflow. • Capital raise of $10 million to accelerate growth and improve balance sheet strength completed in August 2024. Following further evaluation of resourcing requirements and funding options to progress US market entry plans, the Group determined to pause the next phase of investment in favour of focusing on the underlying business. Aligned with the delayed commencement of further US market entry activity, investment in the Group’s next generation device was also paused. FY25 priorities The Company will continue to drive momentum toward achieving positive operating cashflow by the end of FY25. Key priorities include: • Improve margins through pricing and operational efficiency. • Accelerate penetration of Penthrox in Australian hospital emergency departments. • Grow Penthrox in global markets. • Drive continued growth in Respiratory. OUTLOOK FY25 underlying EBIT The Group expects positive momentum in margins and earnings to continue in FY25, with underlying EBIT to be strongly improved on FY24, driven by higher average Penthrox prices and operational efficiencies of $3-4 million. Positive operating cashflow is expected to be achieved by the end of FY25. FY25 capital expenditure Capital expenditure in FY25 is expected to reduce to around $1.5-2.0 million. OTHER EVENTS OF SIGNIFICANCE Other than mentioned above, there has not been any matter or circumstance that has arisen that has significantly affected, or may significantly affect the operations of the Group, the results of those operations, or the state of affairs of the Group in future years. NOTES (1) In the prior year Revenue excludes Contract termination revenue arising from the termination of agreements for the distribution of Penthrox in China ($18.5 million), and other countries where revenue opportunities are not being pursued ($0.4 million). (2) Underlying EBIT is a non-IFRS financial measure which is calculated as earnings before finance costs, net of interest income, tax and underlying adjustments. (3) Free cash flow is a non-IFRS financial measure which is calculated as net cash flow used in operating activities plus net cash flows used in investing activities. (4) Other comprises unallocated costs associated with corporate overheads, and in the prior period minor costs in relation to the Veterinary business which was discontinued during the 2022 financial year. (5) Underlying EBITDA is a non-IFRS financial measure which is calculated as Earnings before finance costs, net of interest income, tax, depreciation and amortisation and underlying adjustments. (6) Share based payment expense and other non- cash items in the Net cash flows used in operating activities table on page 3 excludes the $5.1 million accelerated share-based payment expense included in underlying adjustments. BUSINESS RISKS Risk recognition and management are considered by the Company as integral to its objectives of creating and maintaining shareholder value, and execution of the Company’s strategy. Effective risk management is key to operational activities and decision-making, strategic planning, resource allocation, compliance, accountability and good governance. The Company operates in a constantly evolving environment of science, regulation and healthcare. We are exposed to risks inherent in the global pharmaceutical and medical devices industry, which includes research and development, supply chain and intellectual property. The Company actively manages a range of risks with the potential to have a material impact on the Group and its ability to achieve its objectives. Identified risks, which are common to companies in the pharmaceutical and medical device industries, have been prioritised by the Company in order of risk and opportunity impact. These risks, which include global trends, have also formed the basis of response planning developed during the period. While every effort is made to identify and manage material risks, additional risks not currently known or detailed below may also affect future performance. The Company’s principal risks, and an explanation of our approach to managing them, are outlined below. Product quality The Company’s products must meet a wide range of regulatory requirements aimed at ensuring the quality and efficacy of its products and the safety of patients. The Company’s financial performance and reputation could be adversely impacted if quality requirements are not met. In managing this risk, the Company’s manufacturing, product quality assurance and pharmacovigilance practices serve to deliver the highest standards of safety and the preservation of our reputation. We adopt and comply with a broad suite of internationally recognised standards through our quality management system, including good manufacturing practice (GMP), good distribution practice (GDP) and audits of third-party vendors and suppliers. Our processes and procedures also meet good pharmacovigilance practice (GPV) and we seek to ensure that product information is up-to-date and contains all relevant information to assist customers and healthcare practitioners to use our products. Auditing of compliance with these standards is frequently undertaken by independent regulatory authorities. Successful commercialisation The Company’s financial performance is dependent on its ability to develop and successfully commercialise our products. The Company will need to evolve and optimally develop its operating model to support growth. Successful commercialisation includes obtaining regulatory approvals, successful product launches into new markets, the ability to identify and onboard promotional partners, ability to use its products in a broader range of approved uses and maintaining adequate pricing for products. The Company faces risks in respect of its key product, Penthrox, including the ability of the Company to drive market growth and market penetration in key markets. The Company implements short-, medium- and long-term strategies and near term objectives that are reviewed at least annually. Where appropriate the Company has adopted a different operating model considering commercialisation challenges. Financial risk In addition to the financial impact arising from commercialisation risk, there are a variety of risks arising from the unpredictability of financial markets, including the cost and availability of funds to meet business needs and movements in market risks such as foreign exchange rates. The Company implements financial risk management practices by managing exposure to financial risks including internal controls and cash flow management. Research & development R&D risk involves understanding the uncertainties and potential challenges associated with innovative projects. There is an inherent risk in research and development activities that the outcome is not favourable, including that clinical endpoints are not met, required criteria is not met, clinical trials are unable to be recruited for, or that design iteration takes longer than anticipated. The Company’s products may be at a clinical stage of development in unapproved markets and further development is necessary. If the Company’s proposed products, data or design iterations are considered not to be safe or efficacious or ineffective for therapeutic purposes or the cost of commercial scale manufacture becomes too expensive, the value of the Company’s technology and 18 19 resulting value of its Shares may be materially harmed. To manage this risk, the Company has a dedicated Research & Development function and the Company closely monitors progress of development activities. The Company also dedicates resources to intellectual property protection. Supply chain Having a sustainable and reliable supply chain is critical to the success of the Company’s objectives, particularly to achieving a consistent, economical, and efficient supply of its products. The Company is reliant on third parties for the manufacture and supply of a substantial portion of its products. Disruptions to that supply chain, caused by an interruption to the availability of a key material or component, may result in unexpected disruption or interruption to our products. Increases in the costs of raw materials or other commodities may adversely affect the Company’s profit margins if higher costs cannot be passed on in the form of price increases or unless the Company can achieve further cost efficiencies in its manufacturing and distribution processes. The Company constantly monitors inventory and demand, maintains critical stock levels and seeks, where possible, to identify alternate sources of supply. Supply of materials were impacted by COVID, requiring the Company to implement risk mitigations, including increased ordering lead times and increased inventory holdings. Proactive supplier management and supplier audits are also important components of the Company’s risk mitigation. Regulatory and legislative risk The Group operates under a broad range of legal, regulatory and tax systems. The Company’s financial strength may be impacted by specific regulatory regimes, changes in regulatory regimes, difficulty interpreting or complying with laws. Changes in laws and regulations, including their interpretation or enforcement, could affect, the Company’s business or products. For example, changes in reimbursement or accounting standards, tax laws and regulations, environmental or climate change laws, restrictions or requirements related to product content, labelling and packaging. The Company and the development / commercialisation of its proposed products / technologies are subject to extensive laws and regulations, including but not limited to the regulation of human medical device products. A risk exists that the Company’s products or data may not satisfy regulatory requirements in markets in which we are seeking approval and ultimately may not gain approval or authorisation, that the approval process may take longer than expected or at greater cost, or approvals are granted with restrictions. As a result, the Company may fail to commercialise or out-license its products. In addition to these, if the Company fails to remain compliant with various evolving regulatory requirements, there is a risk that the Company’s financial performance could be adversely affected. In managing this risk, the Group has a product regulatory compliance framework and a dedicated Regulatory team with inhouse expertise. The Company has developed and seeks to continuously improve its broader regulatory compliance framework. The Company is also actively risk managing the impact of clinical change regulation and potential impact on the supply chain of raw materials. Cyber risk Increasing sophistication of external attackers demands an effective and up-to-date cyber security control environment to prevent significant organisational loss of systems, intellectual property and clinical data, damage to reputation and/or disruption to business. To manage this risk, the Company has focused on cyber security training, enhanced back up procedures, improved firewall and screening mechanisms. 20 Financial Reports 21 Directors’ Report 22 Auditor’s Independence Declaration 43 Independent Auditor’s Report 44 Consolidated Statement of Profit or Loss and Other Comprehensive Income 50 Consolidated Statement of Financial Position 51 Consolidated Statement of Changes in Equity 52 Consolidated Statement of Cash Flows 53 Notes to the Financial Statements 54 Section 1: Performance 1.1 Group results 54 1.2 Revenue from contracts with customers 56 1.3 Taxation 57 1.4 Dividends 59 Section 2: Operating Assets and Liabilities 2.1 Working capital 60 2.2 Unearned income 62 2.3 Non-current assets 62 2.4 Commitments and contingencies 70 2.5 Leases 70 Section 3: Capital Structure 3.1 Net cash 71 3.2 Contributed equity and reserves 72 3.3 Capital management 73 3.4 Going concern 73 3.5 Managing our financial risks 73 Section 4: Remunerating Our People 4.1 Employee benefits 78 4.2 Share based payments 78 4.3 Key management personnel 80 Section 5: Other Disclosures 5.1 Basis of preparation 80 5.2 Related parties disclosure 81 5.3 Parent entity financial information 82 5.4 Controlled entities 83 5.5 Auditor’s remuneration 83 5.6 Segment assets and segment liabilities 84 5.7 Subsequent events 84 Consolidated Entity Disclosure Statement 85 Director’s Declaration 86 Contents Introduction This is the Consolidated Financial Report of Medical Developments International Ltd (“MVP” or the “Company”) and its subsidiaries (together referred to as the “Group”) for the year ended 30 June 2024. This Consolidated Financial Report was issued in accordance with a resolution of the Directors on 26 August 2024. Information is only included in Consolidated Financial Report to the extent the Directors consider it material and relevant to the understanding of the financial statements. A disclosure is considered material and relevant if, for example: • the dollar amount is significant in size and / or by nature; • the Group’s results cannot be understood without the specific disclosure; • it is critical to allow a user to understand the impact of significant changes in the Group’s business during the year; and • it relates to an aspect of the Group’s operations that is important to its future performance. Preparing this consolidated financial report requires management to make a number of judgements, estimates and assumptions to apply the Group’s accounting policies. Actual results may differ from these judgements and estimates under different assumptions and conditions and may materially affect the financial results or the financial position reported in future periods. Key judgements and estimates, which are material to this report, are highlighted in the following notes: • Note 1.3 Deferred tax assets • Note 2.3 Property, plant and equipment • Note 2.3 Goodwill and other intangibles • Note 3.4 Going concern To assist in identifying key accounting estimates and judgements, they have been highlighted as follows: 22 23 DIRECTORS’ REPORT The Directors of Medical Developments International Limited (“MVP” or the “Company”) herewith submit the annual financial report of the Company and the entities it controlled (“Group”) for the financial year ended 30 June 2024. BOARD OF DIRECTORS The following persons were Directors of the Company from their date of appointment up to the date of this report: Non-Executive Mr G Naylor BE (Hons), DipCompSc, MBA, CPA, GAICD, FTSE, MIE(Aust) Non-Executive Chair (since 18 December 2020) Mr Naylor has enjoyed a long and successful international business career. For over 30 years he was a key part of the internationalisation of CSL, holding a range of business and functional leadership roles including Chief Financial Officer. At the time of his retirement from CSL, he was the President of Seqirus where he led the 3-year turnaround of that business into one of the most successful vaccine companies in the world. Mr Naylor joined the MVP Board on 14 October 2020. Public company directorships in the past 3 years Orica Limited (since 1 April 2022) Mr L Hoare AssocDipAppSc(Orth), GradDipBus, GAICD Non-Executive Director (since 27 September 2013) Mr Hoare is an accomplished commercial leader with expertise across multiple Life Science sectors. He is currently the Managing Director of Lohmann & Rauscher, Australia & New Zealand (ANZ), a private EU based medical device company. Previously, he was Managing Director of Smith & Nephew (S&N) ANZ, one of S&N’s largest global subsidiaries outside the USA. He served as President of S&N’s Asia Pacific Advanced Wound Management (AWM) business for 5 years and was a member of the Global Executive Management for the AWM Division (as one of three Regional Presidents). In his 24 years with S&N, he also held roles in marketing, divisional and general management. His career has also included a senior role at Bristol-Myers Squibb, and as Vice-Chair of the board of Australia’s peak medical device industry body, Medical Technology Association of Australia. Mr Hoare is also the Chair of the Human Resources Committee. Public company directorships in the past 3 years Polynovo Limited since 27 January 2016 Ms C Emmanuel-Donnelly B.Sci (Hons), M. ENT, Cert.Int.Prop.Law, MAICD Non-Executive Director (since 26 May 2020) Ms Emmanuel-Donnelly is an experienced IP and business development professional having 35 years’ experience locally and internationally. Ms Emmanuel-Donnelly is a former Executive Manager of Business Development and Commercial at the CSIRO, where she led the management of CSIRO’s IP team and IP portfolio for 14 years and managed the CSIRO equity portfolio for over 5 years. Prior to this role, Ms Emmanuel-Donnelly was in-house IP Counsel for Unilever in the UK and practised as a patent and trademark attorney for Wilson Gunn (UK), Davies Collison Cave and Griffith Hack in Melbourne. Christine is also currently chairwoman of Impedimed Ltd and non- executive director of Polynovo Ltd, Pikcha Holdings Ltd, trading as Seminal. She was previously on the Board of the Institute of Patent & Trademarks Attorneys of Australia for 13 years. Public company directorships in the past 3 years Polynovo Limited since 13 May 2020 Impedimed Limited (since 28 September 2023) Ms M Sontrop B.AppSci, Grad Dip Quality Mgt, Grad Dip Management (Health), MBA, FAICD Non-Executive Director (since 5 March 2021) Ms Sontrop has extensive international experience in the biopharmaceutical sector across manufacturing operations, quality, and business integration. During her 28 years with CSL Limited, Ms Sontrop was an integral part of CSL’s globalisation through a series of major acquisitions. This included primary responsibility for the turnaround of unprofitable manufacturing operations. Subsequently as head of global plasma manufacturing, Ms Sontrop delivered a globally integrated manufacturing network spanning four countries. As head of CSL’s Australia and New Zealand pharmaceutical business, Ms Sontrop and her team delivered Australia’s most successful adolescent/adult immunisation program and achieved USFDA (US Food & Drug Administration) approval to manufacture and export CSL’s seasonal and pandemic influenza vaccines. Ms Sontrop also has significant international governance experience. Public company directorships in the past 3 years IDT Australia Limited from 1 March 2017 to 16 November 2021 Mr R Betts B.Ec, ACA Non-Executive Director (since 11 May 2021) Mr Betts is an experienced executive who has held senior roles with ASX listed entities over 25 years. Mr Betts is currently Chief Financial Officer at Ridley Corporation Limited and was previously Chief Financial Officer at Pact Group Holdings Ltd for 6 years. Prior to that he held executive finance and general management roles at Orica Limited. These roles provided Mr Betts with a deep understanding of working in various jurisdictions, including North America, Europe and Asia. Mr Betts has extensive financial and governance experience within international manufacturing environments. Mr Betts is Chair of the Audit and Risk Committee. Dr R Basser Non-Executive Director (since 1 September 2023) Dr Basser is a qualified physician, with over 30 years of international medical and biopharmaceutical experience. Dr Basser worked as a medical oncologist in Melbourne prior to joining CSL in 2001. During his 21 years at CSL, he held multiple global executive roles, including Head of Global Clinical Development, Chief Medical Officer and Senior VP of Research and Development for CSL Seqirus. Dr Basser has substantial expertise in international drug and vaccine development and spent several years based in the USA. Dr Basser currently serves as a Non- Executive Director on the Boards of Starpharma Holdings Limited and Doherty Clinical Trials. He has previously served on the Board of the ANZ Breast Cancer Trials Group and the Hadassah Australia Medical Research Collaboration. Public company directorships in the past 3 years Starpharma Holdings Limited (since 20 February 2023) Company Secretary Ms T Eaton Company Secretary (since 8 August 2022) Ms Eaton is an experienced General Counsel. Her previous roles include General Counsel at the Australian Red Cross, and prior to that more than ten years in the pharmaceutical industry. This included three years as Legal and Compliance Director at Gilead Sciences ANZ, and more than seven years as Legal Director at Merck & Co. Ms Eaton brings an impressive record of working with public and private stakeholders alike, pricing and business development transactions, and developing and managing compliance and risk frameworks. Ms Eaton also spent 5 years as a lawyer with Minter Ellison and Clayton Utz. 24 25 PRINCIPAL ACTIVITIES MVP delivers emergency medical solutions dedicated to improving patient outcomes in both domestic and international markets. The Company manufactures and distributes Penthrox®, a fast acting trauma and emergency pain relief product, used in hospital emergency departments, ambulance services, sports medicine and for analgesia during short surgical procedures. MVP also distributes a range of respiratory devices for sufferers of asthma and COPD (chronic obstructive pulmonary disease). REVIEW OF OPERATIONS AND FINANCIAL PERFORMANCE A review of the operations and financial performance of the Group during the year and of the results of those operations is contained on pages 8 to 18. CHANGES IN STATE OF AFFAIRS Other than as discussed in the “Review of Operations and Financial Performance” on pages 8 to 18, there was no significant change in the state of affairs of the Group during the year. SIGNIFICANT EVENTS AFTER BALANCE DATE On 26 July 2024 the Group announced a fully underwritten capital raise of $10 million comprising an institutional placement and non-renounceable entitlement offer to accelerate growth and improve balance sheet strength. The institutional component of the placement was completed on 30 July 2024 with gross proceeds of $6.9m being received. The entitlement offer closed on 22 August 2024, with gross proceeds of $3.1 million received on 27 August 2024. Other than included above, there has not been any matter or circumstance that has arisen that has significantly affected, or may significantly affect the operations of the Group, the results of those operations, or the state of affairs of the Group in future years. FUTURE DEVELOPMENTS Information regarding likely developments in the operations of the Group in future financial years is set out in the “Review of Operations and Financial Performance” on pages 8 to 18. ENVIRONMENTAL REGULATIONS The Group’s operations are not subject to any particular and significant environmental regulation. The Group has not incurred any liabilities under any environmental legislation during the financial year. ENVIRONMENTAL, SOCIAL AND GOVERNANCE (ESG) During the year the Group undertook an ESG readiness assessment which will inform development of the Group’s ESG roadmap and preparations for mandatory reporting. Mandatory financial disclosures are expected to be required from FY28 onwards. The Group will develop and prioritise high-level initiatives pertaining to the development of the Group’s ESG strategy and governance. DIVIDENDS No dividends were declared in respect of the current period. No dividends were declared in respect of the previous corresponding period. INDEMNIFICATION OF OFFICERS AND AUDITORS The Company’s Constitution requires the Company to indemnify any person who is, or has been, an officer of the Company (including the Directors) to the extent permitted by law. This is reflected in the letter of appointment entered by the Company with each Director. Consequently, the Company has entered into a Deed of Indemnity and Access with each Director. No Director has received benefits under an indemnity from the Company during or since the end of the year. PROCEEDINGS ON BEHALF OF THE COMPANY No person has applied to the court under section 237 of the Act for leave to bring proceedings on behalf of the Company, or to intervene in any proceedings to which the Company is a party, for the purpose of taking responsibility on behalf of the Company for all or part of those proceedings. No proceedings have been brought or intervened in on behalf of the Company with the leave of the court under section 237 of the Act. DIRECTORS’ MEETINGS The following table sets out the number of directors’ meetings (including meetings of committees of directors) held during the financial year and the number of meetings attended by each director (while they were a director or committee member). DIRECTORS’ SHAREHOLDINGS The following table sets out each director’s relevant interest in shares at the date of this report. nm - not a member of the relevant committee (1) Dr R Basser was appointed as a Non-Executive Director effective from 1 September 2023 Directors hold 140,257 options over shares as at 30 June 2024 (2023: 140,257 options) Scheduled Board Meetings Extraordinary Board Meetings Audit & Risk Commitee Human Resources Commitee Continuous Disclosure Committee Held Attended Held Attended Held Attended Held Attended Held Attended Mr G Naylor 9 9 8 8 nm nm 6 6 2 2 Mr L Hoare 9 9 8 8 nm nm 6 6 nm nm Ms C Emmanuel- Donnelly 9 9 8 8 5 5 nm nm nm nm Ms M Sontrop 9 9 8 8 5 4 6 6 nm nm Mr R Betts 9 9 8 8 5 5 nm nm 2 2 Dr R Basser(1) 8 8 6 5 nm nm 1 - nm nm Relevant interest in Ordinary shares Options over shares Mr G Naylor 950,573 105,502 Mr L Hoare 62,005 9,504 Ms C Emmanuel-Donnelly 56,475 16,435 Ms M Sontrop 20,591 784 Mr R Betts 23,383 8,032 Dr R Basser 15,873 - 1,128,900 140,257 26 27 AUDITED REMUNERATION REPORT This Remuneration Report forms part of the Directors’ Report. MESSAGE FROM THE HUMAN RESOURCES COMMITTEE (HRC) On behalf of the Board of Directors, I am pleased to present MVP’s Remuneration Report for the year ended 30 June 2024 (FY24). The year in review and FY24 executive remuneration outcomes During FY24, under the leadership of Chief Executive Officer (CEO) Brent MacGregor, all employees worked hard to deliver progress on the Group’s strategy in the year. The Group delivered strongly improved financial results in FY24, reflecting efforts across the organisation to grow volume, improve margins, reduce costs and deliver operational improvements. The Group reported growth for Penthrox in Australia and Europe, and further respiratory market share gains in the US. While good progress has been made, we were disappointed that delivered revenue for the year was below target. A longer than expected sales cycle for Penthrox in the Australian hospital segment, where strong lead indicators are yet to be fully reflected in volume growth, and seasonal demand softness in the Australian Respiratory market, impacted financial outcomes in the year. The Group reported lower than target results for EBIT and Free Cash Flow. This resulted in a Business Performance Multiplier of 88%. Incentive outcomes for FY24 reflect the below target performance. The Group progressed several strategic projects in the year, including the transition to a new operating model in Europe, and planning for US market entry. Following further evaluation of resourcing requirements and funding options to progress US market entry plans, the Group has determined to pause the commencement of the next phase of US investment in favour of focusing on the underlying business. Key Management Personnel (KMP) changes during FY24 During the year Dr Russell Basser joined the Board (effective 1 September 2023). Russell is a qualified physician, with over 30 years of international medical and biopharmaceutical experience. Russell’s expertise is highly relevant to the Group’s global expansion opportunities, including the US, as well as being complementary to the Board’s membership and capabilities. Remuneration in FY24 Over the last few years, the Group has improved remuneration structures for executive employees to more closely align with the interests of shareholders. This included changes to remuneration for the CEO. At the FY23 AGM shareholders approved changes to the CEO compensation structure. The principal objectives of the changes were to align the CEO’s compensation more strongly with the interests of shareholders and increase the CEO’s share ownership. In transitioning to the new arrangements, the Group purchased 139,599 on-market shares for the CEO, equivalent in value to the CEO’s FY23 short-term incentive award (STI) of $109,725. The CEO also voluntarily purchased 61,794 shares, equivalent in value to the after-tax proceeds of his FY23 STI. Inclusive of previously held shares, the CEO held 226,393 shares in the Group at the end of the period. From FY24 the CEO has equity components included in both short-term and long-term incentive arrangements. The arrangements align with the structures in place for the rest of the executive team, and expectations of shareholders. The CEO options program was cancelled upon transition to the new arrangements. The cancellation of the program resulted in the recognition of a non-cash share-based payment expense of $5.1 million in the current year. This amount, included in the Executive KMP statutory remuneration table in Section 6 of this report, represents a non-cash accounting adjustment in accordance with AASB2 Share Based Payments. The amount does not reflect a benefit received by the CEO in the current year. We are confident that these changes have strengthened the Company and are in the interests of the shareholders. Leon Hoare Chair of Human Resources Committee 26 August 2024 28 29 AUDITED REMUNERATION REPORT CONTENTS 1. Key Management Personnel (KMP) 2. Executive remuneration framework 3. Executive remuneration structure 4. Executive remuneration outcomes 5. Business performance 6. Statutory remuneration tables 7. Equity holdings of KMP 8. Governance This Remuneration Report for the year ended 30 June 2024 outlines the remuneration arrangements of the Group in accordance with the requirements of the Corporations Act 2001 (the Act) and its regulations. This information has been audited as required by section 308(3C) of the Act. 1. Key Management Personnel (KMP) The Remuneration Report details the remuneration arrangements of KMP who are defined as those persons having authority and responsibility for planning, directing and controlling the major activities of the Company and the Group, directly or indirectly, including any director (whether executive or otherwise) of the Company. For the purposes of this report, the term KMP includes the CEO, the CFO, and all Non-Executive Directors of the Board There were no other changes to KMP after the reporting date and before the date the financial report was authorised for issue. Executive KMP employment contracts Remuneration and other terms of employment for the CEO and CFO are formalised in employment contracts. The material terms of the employment contracts for the Executive KMP are summarised in the table below. Name Position Term as KMP in 2024 Executive KMP Mr B MacGregor CEO Full Year Ms A James CFO Full Year Non-Executive Directors (NEDs) Mr G Naylor Non-Executive Chair Full Year Mr L Hoare Non-Executive Director Full Year Ms C Emmanuel-Donnelly Non-Executive Director Full Year Ms M Sontrop Non-Executive Director Full Year Mr R Betts Non-Executive Director Full Year Dr R Basser Non-Executive Director Appointed on 1 September 2023 CEO Contractual terms Conditions Duration of contract Permanent full time employment contract until notice given by either party Notice period Six months’ notice by either party Termination clauses From 1 July 2023 the termination clause has been amended to 12 months annual base salary averaged over the last 3 years. CFO Contractual terms Conditions Duration of contract Permanent full time employment contract until notice given by either party Notice period Three months’ notice by either party 30 31 2. Executive remuneration framework The Company’s remuneration framework seeks to appropriately reward, incentivise and retain senior executives in alignment with the interests of shareholders. The remuneration framework includes traditional fixed annual remuneration components (including base salary, superannuation and other benefits), a STI and long-term incentive awards (LTI). The remuneration framework for the Company is detailed below for FY24. Executive Remuneration Framework Designed to drive Group Strategy and ensure that the interests of senior executives are aligned with those of shareholders. Governing principles of the remuneration framework Aligns with the Group’s purpose, culture and strategy Attracts, retains and motivates capable talent Complies with the Group’s performance and risk management framework Creation of shareholder value Reward framework components Annual remuneration STI at risk LTI at risk Cash salary, superannuation and other benefits, that are reviewed on an annual basis. Competitively set to reward, incentivise and retain senior executives, reflecting the role scope and accountabilities. Determined based on market benchmarking, individual and business unit performance and overall performance of the Group. At risk annual rewards, entitlement to which is determined by the achievement of financial and individual goals against targets. These rewards align remuneration with the achievement of short-term strategic objectives and financial performance. The STI is measured as a % of fixed annual remuneration (the target), with payment range between 0% and 130% of target. To strengthen alignment with shareholders, the STI is paid in cash and equity (50/50) for Executive KMP and other senior executive participants, with the equity component subject to a 1 year holding lock. At risk rewards, entitlement to which is based on the delivery of agreed shareholder returns over an extended period. These rewards align executive remuneration with delivery of long-term strategy and the creation of shareholder wealth. The Company introduced the LTI in FY23 for select senior executives including the CFO, which includes provision for the allocation of performance rights which vest as fully paid ordinary shares on the achievement of agreed shareholder returns over a 3-year period. The CEO joined the LTI in FY24 following shareholder approval at the 2023 Annual General Meeting. Executive remuneration mix The target remuneration mix of the above framework components (assuming STI at target and the face value of LTI) in FY24 would be as follows: Fixed Remuneration STI cash STI equity LTI CEO CFO 67% 12% 12% 9% 71% 11% 11% 7% The Directors believe that this mix aligns rewards with the interests of our shareholders and drives performance against short term and long term business objectives. 3. Executive remuneration structure Detailed components of the remuneration structure are outlined below. Annual Remuneration Payment vehicle Fixed Annual Remuneration (FAR) comprising of cash salary and superannuation benefits. Other benefits, including travel and tax advice allowances, long service leave benefits and fringe benefits tax (FBT) benefits. STI Payment vehicle CEO and CFO FY24: 50% cash and 50% equity Opportunity CEO: at target 35% of FAR (maximum opportunity of 45.5%), 50% payable in cash and 50% as fully paid shares) CFO: at target 30% of FAR (maximum opportunity of 39%), 50% payable in cash and 50% as fully paid shares. Performance measures Achievement of EBIT, free cash flow (FCF) and operational and strategic objectives, and performance in alignment with Company values. The STI is calculated as follows: FAR X STI Target X Business Performance Multiplier X Individual Performance Multiplier = STI total Business performance multiplier (BPM) Based on achievement of the EBIT and FCF target calculated as follows: EBIT and FCF compared to target BPM (50% EBIT + 50% FCF) $3.5 million or greater below 70% $0.5-$3.5 million below Straight-line vesting 70-100% Within $0.5 million 100% $0.5-$3.5 million above Straight-line vesting 100-130% $3.5 million or greater above 130% The Board may adjust from the EBIT and FCF outcomes the financial impact of non-operational or one-off events. An adjustment may also be made based on the quality of the financial result, management of risk and shareholder expectations. Target = BPM of 100%, Maximum = BPM of 130%, Minimum = BPM of 70%. Equal weighting is given to the achievement of the EBIT and free cash flow targets. Individual performance multiplier (IPM) Based on the participants performance rating across two dimensions, being the delivery of agreed business objectives and alignment with Company values. Target performance = IPM of 100%, Unsatisfactory performance = IPM of 0%, Outstanding performance = IPM of 130% STI (equity component) Payable in fully paid ordinary MVP shares. The number of shares allocated is determined by dividing the amount payable in equity by the VWAP of MVP shares traded in the 5 trading days following announcement of the Company’s full year results. The shares are subject to a one year holding lock. 32 33 LTI Overview The plan consists of performance rights granted annually. Under the plan, performance rights were granted to the CFO and select senior executives. The CEO was also granted performance rights for the first time in FY24. Details in relation to performance hurdles, vesting conditions and other terms and conditions are outlined below. Opportunity CEO: Maximum opportunity equivalent to 50% of FAR CFO: Maximum opportunity equivalent to 20% of FAR Senior Executives: Maximum opportunity ranging between the equivalent of 10-20% of FAR. Instrument Performance rights Performance period The performance period commences on the first day of the current fiscal year and is measured over a three- year vesting period. The first testing period will be for the year ended 30 June 2025. In relation to the FY23 grant, testing occurs only once. Allocation approach The number of performance rights allocated to each KMP is based on the following: FAR X Individual target % = LTI participation ÷ Fair Value of each Performance Right = Performance Rights granted to KMP The fair value of each right reflects the expected value of each right to the participant today, taking into consideration the current share price, the performance hurdle (minimum 33% share price growth), vesting conditions and the probability of various share price outcomes at the end of the performance period. The fair valuation has been performed by an independent valuer. Performance hurdle Vesting of rights is subject to achieving volume weighted average share price (VWAP) growth targets over a three-year performance period. LTI Vesting Schedule Vesting % VWAP share price growth up to 33% 0% VWAP share price growth between 33% and 100% Straight line vesting on a pro rata basis VWAP share price growth at 100% or above 100% If no dividends are paid over the 3-year vesting period the minimum performance hurdle would be equivalent to delivering total shareholder return of 33%. Target performance would be equivalent to total shareholder return of 100%. Cessation of Employment If an executive resigns or is terminated for cause, any unvested LTI awards will be forfeited, unless otherwise determined by the Board. Any such performance rights will be subject to the original terms and conditions, and the discretion of the Board. Rights attaching to performance rights Performance rights do not carry any dividend or voting entitlements prior to vesting, or priority over any creditors of MVP upon liquidation or winding up of MVP. Shares allocated upon vesting of performance rights will carry the same rights as other ordinary shares. Malus and Clawback At the discretion of the Board LTI awards will be forfeited where there has been any fraud, dishonesty, or breach of obligations of the Group policies or codes of conduct. Change of Control Provisions In the event of change of control, or a scheme of arrangement, selective capital reduction or other transaction is initiated which has an effect similar to a full takeover bid for shares in the Company, then participants are entitled to accept the takeover bid or participate in the other transaction in respect of all or part of their awards other than exempt share awards notwithstanding that the restriction period in respect of such awards has not expired. The Board may waive any vesting conditions at their discretion. 4. Executive remuneration outcomes Actual remuneration received The table below shows the remuneration the executive KMP actually received for FY24 (paid in cash or accrued), or in the case of equity awards, the value that vested in FY24. This table differs from the statutory table included in Section 6, in that the table below excludes remuneration from unvested share-based payments. The Directors believe this information is helpful to shareholders. (1) Fixed remuneration comprises base salary and post-employment benefits as disclosed in the statutory remuneration table in Section 6. (2) Other benefits comprises other short-term benefits and other long-term benefits as disclosed in the statutory remuneration table in Section 6. STI outcomes STI awards are measured on the delivery of financial and business objectives approved by the Board at the start of the financial year with clear alignment to strategy. STI awards are calculated using the STI Multiplier detailed above. KMP objectives and achievement against targets for the year are included in the table below. Objectives Measure Target Achieved Achievement (0-130%) Weighting Weighted Outcome EBIT $million (9.4) (11.6) 83% 50% 41% Free cashflow $million (12.9) (14.0) 94% 50% 47% Business Performance Multiplier 88% Grow Penthrox and Respiratory volume in key markets(1) % growth Various Partially achieved 40% 35% 14% Increase global Penthrox pricing $million 2.1 2.2 105% 20% 21% Deliver operational improvements and efficiency Various Various Achieved 100% 15% 15% Deliver agreed strategic project milestones(2) Various Various Partially achieved 70% 30% 21% Individual performance multiplier – Mr MacGregor 70% Individual business objectives Various Achieved 100% 100% 100% Individual performance multiplier – Ms James 100% Fixed annual remuneration(1) Other Benefits(2) STI (cash) STI (equity) Other Benefits Total $ $ $ $ $ $ Mr B MacGregor 629,781 64,119 68,339 68,339 109,725 940,303 Ms A James 388,207 1,155 51,582 51,582 - 492,526 (1) Includes increased penetration of Penthrox in Australia, and growth in the US Respiratory market. (2) Specific disclosure of objectives, target milestones and achieved outcomes are not reported due to commercial sensitivity. 34 35 5. Business performance The table below summarises key indicators of the performance of the Company and relevant shareholder returns over the past 5 financial years. (1) Revenue and commentary on performance has been included above in the Review of Operations and Financial Performance. (2) Excludes contract termination revenue in FY21 of $8.9 million arising from the termination of the European distribution rights for Penthrox previously held by Mundipharma. Excludes contract termination revenue of $18.9 million in FY23 arising from the termination of agreements for the distribution of Penthrox in China ($18.5 million), and other countries where revenue opportunities are not being pursued ($0.4 million). (3) Underlying EBIT and commentary on performance has been included above in the Review of Operations and Financial Performance. The tables below include details of the KMP STI outcomes for the current year. The STI for Mr MacGregor and Ms James is payable in cash 50%; and 50% as fully paid shares. LTI plans The table below outlines the LTI plans that remain untested. (1) Testing is due to occur at the end of September 2024, performance rights are not expected to vest. The testing takes place following the three-year performance period and will be based on the VWAP of shares traded in MVP for the 20-day trading period commencing 5 trading days after the results announcement in the final year of the performance period. Testing occurs only once. LTI outcomes The table below outlines key details in relation to performance rights granted to KMP, and associated remuneration during the current year. Each LTI allocation has a vesting period of 3 years. Options program (CEO) All options granted to Mr MacGregor on commencement of his employment in FY21 were cancelled in the current year. No benefit was received by Mr MacGregor. Remuneration outcomes have been outlined in the Executive KMP statutory remuneration table in Section 6. Grant Date Performance rights granted Fair value of rights at grant date Value of rights included in compensation for the year Performance period Mr MacGregor FY24 LTI 27 October 2023 617,620 $271,753 $90,584 1 July 2023 to 30 June 2026 Ms James FY24 LTI 27 October 2023 152,285 $67,005 $22,335 1 July 2023 to 30 June 2026 FY23 LTI 22 December 2022 84,930 $57,752 $19,251 1 July 2022 to 30 June 2025 $41,586 Maximum STI opportunity STI Paid STI earned % of maximum STI forfeited % of maximum Mr MacGregor $286,550 $136,678 48% 52% Ms James $151,401 $103,164 68% 32% Plan Grant date Performance period Performance measure Outcome FY22 LTI 22 Dec 2022 1 July 2022 to 30 June 2024 Share price growth from baseline share price of $4.02 Not yet tested(1) FY23 LTI 22 Dec 2022 1 July 2022 to 30 June 2025 Share price growth from baseline share price of $1.72 Not yet tested FY24 LTI 27 Oct 2023 1 July 2023 to 30 June 2026 Share price growth from baseline share price of $0.898 Not yet tested Performance measure 2020 2021 2022 2023 2024 Revenue ($000s)1 22,535 16,329(2) 21,943 32,337(2) 33,149 Revenue growth % 7.9% (27.5%) 34.4% 47.0% 2.5% Underlying EBITDA (000’s) 2,695 (6,372) (11,724) (15,133) (8,237) Underlying EBIT (000’s)3 98 (10,121) (14,669) (18,246) (11,631) Reported EBIT (000’s) 98 (14,928) (15,850) (7,957) (33,142) Statutory net profit / (loss) after tax ($000’s) 379 (12,565) (12,407) (5,609) (40,992) Share price at end of period $6.98 $4.50 $1.46 $0.78 $0.39 Total dividends (cps) 2.00 - - - - Basic earnings / (loss) per share (cps) 0.58 (18.35) (17.41) (6.66) (47.50) 36 37 6. Statutory remuneration tables Executive KMP statutory remuneration The table below summarises remuneration to Executive KMP. Short term benefits Share based payments Year Base salary STI (cash) Other benefits(1) Other long term benefits(2) Post employment benefits(3) STI (equity) Other equity LTI Total excluding accelerated SBP expense Accelerated charge for share based payments Total Remuneration linked to performance % Mr B MacGregor 2024 602,382 68,339 59,222 4,897 27,399 68,339(4) 109,725(5) 90,584(6) 1,030,887 5,135,613(8) 6,166,500 22%(8) 2023 576,127 109,725 45,940 1,405 25,292 - - 1,183,396(7) 1,941,885 - 1,941,885 67% Ms A James 2024 349,736 51,582 - 1,155 38,471 51,582(4) - 41,586(6) 534,112 - 534,112 27% 2023 338,182 56,054 - 560 35,509 56,053 - 19,251 505,609 - 505,609 26% Total Executive KMP remuneration 2024 952,118 119,921 59,222 6,052 65,870 119,921 109,725 132,170 1,564,999 5,135,613 6,700,612 2023 914,309 165,779 45,940 1,965 60,801 56,053 - 1,202,647 2,447,494 - 2,447,494 (1) Other benefits include allowances for travel and reimbursement for tax advice for Mr MacGregor, inclusive of FBT payable by the Company on these benefits. (2) Represents the movement in the long service leave provision during the current period. (3) Represents superannuation benefits paid to Mr MacGregor and Ms James. (4) Represents a grant of fully paid shares to Mr MacGregor and Ms James, being 50% of their STI for the current year. (5) Represents shares purchased by the Group on market for Mr MacGregor as part of the transition to new remuneration arrangements approved at the 2023 AGM. (6) Represents the amortisation of the grant date fair value of performance rights granted to Mr MacGregor and Ms James. The performance rights valuation was performed by an independent valuer, and the expense was recognised in the FY24 statement of profit or loss and other comprehensive income over the relevant vesting period in accordance with AASB2 Share Based Payments. (7) Represents the amortisation of the grant date fair value of options granted to Mr MacGregor in November 2020. The valuation was performed by an independent valuer, and the expense was recognised in the prior year statement of profit or loss and other comprehensive income over the relevant vesting period in accordance with AASB2 Share Based Payments. (8) Represents the share-based payment expense arising on the cancellation of all options granted under the CEO options program (options granted to Mr MacGregor at the commencement of his employment). The options were cancelled upon Mr MacGregor’s transition to new CEO remuneration arrangements in FY24 and approved at the 2023 AGM. The expense recognised in the period is the accelerated amortisation of the unamortised fair value as at 30 June 2023, which has not been recognised in the statement of profit and loss and other comprehensive income in prior periods. This is a non-cash adjustment required under AASB2 Share Based Payments and does not represent a benefit to Mr MacGregor. No options under the CEO options program vested. The remuneration included in the calculation of “Remuneration linked to performance percentage” excludes this expense. 38 39 6. Statutory remuneration tables (continued) KMP performance rights holdings The table below shows the movement in KMP performance rights holdings during the year, and the balance of vested and unvested rights at the end of the financial year. 7. Equity holdings of KMP The following table shows the respective shareholdings of KMP (directly and indirectly) and any movements during the year ended 30 June 2024 (1) Mr MacGregor volunteered to purchase additional shares in the Company equivalent in value to the after-tax proceeds of his FY23 STI. Balance at 1 July 2023 Number granted Balance at 30 June 2024 Vested at 30 June 2024 Unvested at 30 June 2024 CEO - 617,620 617,620 - 617,620 CFO 84,930 152,285 237,215 - 237,215 84,930 769,905 854,835 - 854,835 6. Statutory remuneration tables (continued) Non-Executive KMP remuneration The Human Resources Committee seeks to attract and retain Non-Executive Directors (NEDs) of the highest calibre, who have the appropriate experience and expertise to oversee the governance of MVP and provide direction to senior management on the running of the Company. NED fees are set with reference to their responsibilities, time commitment and contribution to committees, whilst incurring a cost that is acceptable to shareholders. NEDs do not participate in any incentive plans. The table below summarises payments made for NED fees. (1) (1) The Chair of the Board receives fees of $95,000 (2023: $95,000), while remaining Board members receive fees of $60,000 (2023: $60,000). Non-Executive KMP Year Short Term Benefits Post-Employment Benefits Total(1) Fees $ Superannuation $ $ Mr G Naylor(1) 2024 85,586 9,414 95,000 2023 85,973 9,027 95,000 Mr L Hoare 2024 58,513 1,487 60,000 2023 60,000 - 60,000 Ms C Emmanuel-Donnelly 2024 54,054 5,946 60,000 2023 54,299 5,701 60,000 Ms M Sontrop 2024 54,054 5,946 60,000 2023 54,299 5,701 60,000 Mr R Betts 2024 54,054 5,946 60,000 2023 54,299 5,701 60,000 Dr R Basser (appointed 1 September 2023) 2024 45,045 4,955 50,000 2023 - - - Former Non-Executive KMP Mr D J Williams (resigned 26 April 2024) 2024 - - - 2023 45,249 4,751 50,000 Mr R M Johnston (resigned 27 October 2022) 2024 - - - 2023 18,100 1,900 20,000 Total Non-Executive KMP remuneration 2024 351,306 33,694 385,000 2023 372,219 32,781 405,000 Number of shares Balance 1 July 2023 Acquired Allocated through employee remuneration schemes Balance 30 June 2024 Mr G Naylor 894,573 56,000 - 950,573 Mr L Hoare 62,005 - - 62,005 Ms C Emmanuel-Donnelly 56,475 - - 56,475 Ms M Sontrop 20,591 - - 20,591 Mr R Betts 23,383 - - 23,383 Dr R Basser - 15,873 - 15,873 Mr B MacGregor 25,000 61,794(1) 139,599 226,393 Ms A James - - 62,982 62,982 1,082,027 133,667 202,581 1,418,275 40 41 8. Governance The following represents MVP’s remuneration governance framework. The HRC comprises at least three Non-Executive Directors and meet as often as the members deem necessary to fulfil the Committee’s obligations. The HRC comprises of the following Directors, Mr Hoare (Chair), Mr Naylor and Ms Sontrop. External remuneration advice received in FY24 During the year the HRC did not obtain remuneration advice or recommendations from external remuneration consultants. MVP Board The Board takes overall accountability for the company and is committed to the highest standard of corporate governance. To assist in the execution of these responsibilities the Board has established the following committees: • Human Resources Committee (HRC) • Audit and Risk Committee (ARC) • Continuous Disclosure Committee (CDC) Responsibilities of the Board include reviewing the terms and conditions of the CEO’s remuneration and ongoing performance as well as oversight of all matters associated with the organisation’s human resources. The Board reviews, and when appropriate, approves recommendations from the HRC in relation to the remuneration of the CEO and executives. The Board also reviews, and when appropriate approves recommendations from the ARC in relation to audit and risk matters. Human Resources Committee Audit and Risk Committee The HRC works on behalf of the MVP Board to oversee the Group’s human resources and remuneration strategy in the best interests of MVP shareholders. The Committee provides an objective review and oversight of people and remuneration policies and frameworks so that they: • Align with the Group’s purpose, culture and strategy. • Comply with the Group’s remuneration framework. • Comply with legal and regulatory requirements. • Remain appropriate to changing market conditions. The Committee sets the remuneration framework and monitors the activities listed below, including making recommendations and providing reports to the Board on the following: • The salary package of the CEO and compensation of the non-executive directors (changes are approved by the Board as a whole and shareholders if required) • Annual remuneration for senior executives and all other staff including, but not limited to, fixed remuneration, short term incentives, and long- term incentives, aligned to business strategy in the interests of shareholders. • Assess remuneration practices for internal and external alignment. • Recruitment, retention and termination policies and practices for senior management. Any other remuneration or human resources tasks referred to the Committee by the Board. The ARC works on behalf of the MVP Board to assist in fulfilling its corporate governance and oversight responsibilities in relation to the following: • The integrity of MVP’s financial reporting. • The effectiveness of MVP’s systems of financial risk management and internal control. • The integrity of the external audit process. • MVP’s risk profile and risk policy. • The effectiveness of MVP’s risk management framework and supporting risk management systems, including work health and safety. Continuous Disclosure Committee The CDC acts as a delegated authority of the Board to: • Review and consider the materiality of potentially disclosable information it receives to determine whether that information is market sensitive; • Make recommendations to the Board as to the content of the information to be disclosed; and • Approve certain disclosures on behalf of the Board as set out in the Continuous Disclosure Policy. External remuneration advice External remuneration advice is sought by the HRC and Board where necessary. The nature of the external advice and the amounts paid to remuneration consultants are disclosed annually in the Remuneration Report. KMP ordinary shares under options The following table shows the number of options held over ordinary shares by KMP (directly and indirectly) and any movements during the year ended 30 June 2024 (1) On acceptance by Mr MacGregor of an invitation to join the Company LTI program in the current year, options he previously held were cancelled. These remuneration arrangements were approved at the 2023 AGM. (2) Options attaching to shares acquired by KMP in the capital raising completed in August 2022. Number of shares Balance 1 July 2023 Acquired Forfeited Balance 30 June 2024(2) Mr G Naylor 105,502 - - 105,502 Mr L Hoare 9,504 - - 9,504 Ms C Emmanuel-Donnelly 16,435 - - 16,435 Ms M Sontrop 784 - - 784 Mr R Betts 8,032 - - 8,032 Dr R Basser - - - - Mr B MacGregor 1,978,704 - (1,968,704)(1) 10,000 2,118,961 - (1,968,704) 150,257 42 43 Liability limited by a scheme approved under Professional Standards Legislation. Member of Deloitte Asia Pacific Limited and the Deloitte organisation. 26 August 2024 The Board of Directors Medical Developments International Limited 4 Caribbean Drive Scoresby VIC 3179 Dear Board Members Auditor’s Independence Declaration - Medical Developments International Limited In accordance with section 307C of the Corporations Act 2001, I am pleased to provide the following declaration of independence to the directors of Medical Developments International Limited. As lead audit partner for the audit of the financial report of Medical Developments International Limited for the year ended 30 June 2024, I declare that to the best of my knowledge and belief, there have been no contraventions of: (i) the auditor independence requirements of the Corporations Act 2001 in relation to the audit; and (ii) any applicable code of professional conduct in relation to the audit. Yours sincerely DELOITTE TOUCHE TOHMATSU Melanie Sutton Partner Chartered Accountants Deloitte Touche Tohmatsu ABN 74 490 121 060 477 Collins Street Melbourne, VIC, 3000 Australia Phone: +61 3 9671 7000 www.deloitte.com.au 18 NON-AUDIT SERVICES During the year, the Company’s auditor, performed other assignments in addition to their statutory audit responsibilities. Details of the amounts paid or payable for non-audit services provided during the year are as follows: The Directors are satisfied that the provision of non-audit services, during the year, by the auditor is compatible with the general standard of independence for auditors imposed by the Corporations Act 2001. The directors do not believe that the nature of these services compromises the general principles relating to auditor’s independence, as set out by the Chartered Accountants Australia and New Zealand. CORPORATE GOVERNANCE STATEMENT A copy of the Company’s Corporate Governance statement can be found at www.medicaldev.com/investors-media/corporate-governance/ AUDITOR’S INDEPENDENCE DECLARATION The auditor’s independence declaration is included on page 43. ROUNDING The Company is a company of a kind referred to in ASIC Corporations (Rounding in Financial/Directors’ Reports) Instrument 2016/191 dated 24 March 2016, and in accordance with that Corporate Instrument, amounts in the Directors’ Report and financial report are rounded to the nearest $1,000, unless otherwise stated. Signed in accordance with a resolution of the Board of Directors made pursuant to s. 298(2) of the Corporations Act 2001: On behalf of the directors $ 2024 2023 Tax services 49,300 38,180 Other 48,828 - Total 98,128 38,180 Gordon Naylor Company Chair 26 August 2024 44 45 Liability limited by a scheme approved under Professional Standards Legislation. Member of Deloitte Asia Pacific Limited and the Deloitte organisation. Deloitte Touche Tohmatsu ABN 74 490 121 060 477 Collins Street Melbourne, VIC, 3000 Australia Phone: +61 3 9671 7000 www.deloitte.com.au Independent Auditor’s Report to the members of Medical Developments International Limited Report on the Audit of the Financial Report Opinion We have audited the financial report of Medical Developments International Limited (the “Company”) and its subsidiaries (the “Group”) which comprises the consolidated statement of financial position as at 30 June 2024, the consolidated statement of profit and loss and other comprehensive income, the consolidated statement of changes in equity and the consolidated statement of cash flows for the year then ended, and notes to the financial statements including material accounting policy information and other explanatory information, the directors’ declaration and the consolidated entity disclosure statement. In our opinion, the accompanying financial report of the Group is in accordance with the Corporations Act 2001, including:  Giving a true and fair view of the Group’s financial position as at 30 June 2024 and of its financial performance for the year then ended; and  Complying with Australian Accounting Standards and the Corporations Regulations 2001. Basis for Opinion We conducted our audit in accordance with Australian Auditing Standards. Our responsibilities under those standards are further described in the Auditor’s Responsibilities for the Audit of the Financial Report section of our report. We are independent of the Group in accordance with the auditor independence requirements of the Corporations Act 2001 and the ethical requirements of the Accounting Professional & Ethical Standards Board’s APES 110 Code of Ethics for Professional Accountants (including Independence Standards) (the Code) that are relevant to our audit of the financial report in Australia. We have also fulfilled our other ethical responsibilities in accordance with the Code. We confirm that the independence declaration required by the Corporations Act 2001, which has been given to the directors of the Company, would be in the same terms if given to the directors as at the time of this auditor’s report. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion. Key Audit Matters Key audit matters are those matters that, in our professional judgement, were of most significance in our audit of the financial report of the Group for the current period. These matters were addressed in the context of our audit of the financial report as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters. 19 Key Audit Matter How the scope of our audit responded to the Key Audit Matter Capitalisation of intangible assets Refer to Note 2.3 Non-Current Assets and Note 1.1 Group Results As at 30 June 2024, the Group holds $16.0 million of capitalised registration costs and $1.0 million of capitalised development costs. $13.9 million of capitalised registration costs and $1.9 million of capitalised development costs were impaired during the year due to no longer meeting the criteria to be capitalised. Accounting standards require management to use their judgement to determine:  Whether expenditure relates to development activities or research activities.  The technical feasibility of completing the intangible asset so that it will be available for use.  Whether the Group intends to complete the intangible asset and either use or sell it.  The probability of expected future economic benefits flowing to the Group.  The availability of resources to complete the development and to use or sell the intangible asset.  The expenditure attributable to the asset during its development.  Whether the useful life assigned to each asset is appropriate. Where expenditure does not meet the recognition criteria under accounting standards or has historically been capitalised and no longer meets these criteria, it should be expensed or impaired. Our procedures included:  Obtaining an understanding of the process undertaken by management to determine whether expenditure should be capitalised as an intangible asset.  Assessing the appropriateness of management’s accounting policy for capitalisation and management’s application of that policy with respect to current year additions to intangible assets.  Assessing all capitalised intangible assets not yet available for use and a sample of capitalised intangible assets in use at balance date to determine whether it is probable that expected future economic benefits attributable to those assets will flow to the Group.  Assessing management’s identification of intangible assets no longer meeting the recognition criteria under accounting standards.  Reviewing the listing of capitalised intangible assets at balance date to verify that: o Amortisation has commenced on intangible assets that are in use, and o The useful lives assigned to assets in use are appropriate.  Evaluating the appropriateness of the disclosures included in Note 1.1 and 2.3 to the financial statements. Carrying value of the Pain Management cash generating unit Refer to Note 2.3 Non-Current Assets As at 30 June 2024, the carrying value of the Pain Management group of cash generating units (“CGU”) included $3.8 million of goodwill. Goodwill and intangible assets not yet available for use are required to be assessed for impairment annually and whenever there is an indicator of impairment. The recoverable amount of the Pain Management CGU has been determined by management based on a value in use (“ViU”) model, which incorporates significant judgement related to the estimation of future cash flows, short term growth rates, long term growth rates and an appropriate discount rate. The Group’s estimate of recoverable amount for the Pain Management CGU is based on future cash flows which are contingent upon the Group continuing to grow in established markets such as Australia and the United Kingdom in the short to medium term. Our audit procedures included:  Understanding management’s processes and controls related to the preparation of the value in use models for the Pain Management CGU.  Agreeing forecast cash flows to the latest Board approved budget for FY25 and the Group’s longer term business plans, assessing the reasonableness of the forecast cash flows with reference to current performance and drivers of expected future performance.  In conjunction with our valuation specialists, assessing the ViU methodology used by management, testing the mathematical integrity of management’s VIU model, as well as comparing the discount rates and long-term growth rates used to external benchmark data.  Performing sensitivity analysis on the impairment model by applying varied discount rates and growth projections to simulate alternative market conditions and outcomes.  Evaluating the appropriateness of the disclosures included in Note 2.3 to the financial statements. 46 47 Other Information The directors are responsible for the other information. The other information comprises the information included in the Group’s annual report for the year ended 30 June 2024 but does not include the financial report and our auditor’s report thereon. Our opinion on the financial report does not cover the other information and we do not express any form of assurance conclusion thereon. In connection with our audit of the financial report, our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the financial report or our knowledge obtained in the audit, or otherwise appears to be materially misstated. If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are required to report that fact. We have nothing to report in this regard. Responsibilities of the Directors for the Financial Report The directors are responsible:  For the preparation of the financial report in accordance with the Corporations Act 2001, including giving a true and fair view of the financial position and performance of the Group, in accordance with Australian Accounting Standards; and  For such internal control as the directors determine is necessary to enable the preparation of the financial report in accordance with the Corporation Act 2001, including giving a true and fair view of the financial position and performance of the Group, and is free from material misstatement, whether due to fraud or error. In preparing the financial report, the directors are responsible for assessing the ability of the Group to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the directors either intend to liquidate the Group or to cease operations, or has no realistic alternative but to do so. Liquidity As disclosed in Note 3.4 the Group had a cash balance of $9.7 million at 30 June 2024, and net operating cash outflows of $10.8 million. Subsequent to year-end, the Group announced a fully underwritten capital raise of approximately $10 million comprising an institutional placement and non-renounceable entitlement offer to accelerate growth and improve balance sheet strength. The institutional component of the placement was completed on 30 July 2024 with gross proceeds of $6.9 million being received. The entitlement offer closed on 22 August 2024, with gross proceeds of $3.1 million expected to be received on 27 August 2024. The Group continues to closely manage its ongoing liquidity as disclosed in Note 3.4 to the financial statements. This requires the achievement of cash flow forecasts which are subject to variation due to factors which are outside the control of the Group, to enable the Group to continue to meet its operating cash commitments. Our procedures included:  Comparing the Group’s forecast cash flows against the FY25 Board approved budget and testing the accuracy of the model.  Challenging the key assumptions in management’s forecast cash flows for the 12 months following approval of the financial report.  Assessing the capital raise undertaken subsequent to year-end by reading and understanding the key terms of the underwriting agreement, examining market announcements made by the Group and vouching the gross proceeds net of costs from the institutional placement to the Group’s bank statement.  Assessing consistency between the forecasts used to test the Group’s going concern basis and those used in management’s annual impairment testing.  Performing sensitivity analysis on the cash flow forecast for a range of reasonable possible scenarios. We also assessed the adequacy of the disclosures included in Note 3.4 to the financial statements. Auditor’s Responsibilities for the Audit of the Financial Report Our objectives are to obtain reasonable assurance about whether the financial report as a whole is free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with the Australian Auditing Standards will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of this financial report. As part of an audit in accordance with the Australian Auditing Standards, we exercise professional judgement and maintain professional scepticism throughout the audit. We also:  Identify and assess the risks of material misstatement of the financial report, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our opinion. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control.  Obtain an understanding of internal control relevant to the audit in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Group’s internal control.  Evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates and related disclosures made by the directors.  Conclude on the appropriateness of the directors’ use of the going concern basis of accounting and, based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the Group’s ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in our auditor’s report to the related disclosures in the financial report or, if such disclosures are inadequate, to modify our opinion. Our conclusions are based on the audit evidence obtained up to the date of our auditor’s report. However, future events or conditions may cause the Group to cease to continue as a going concern.  Evaluate the overall presentation, structure and content of the financial report, including the disclosures, and whether the financial report represents the underlying transactions and events in a manner that achieves fair presentation.  Obtain sufficient appropriate audit evidence regarding the financial information of the entities or business activities within the Group to express an opinion on the financial report. We are responsible for the direction, supervision and performance of the Group’s audit. We remain solely responsible for our audit opinion. We communicate with the directors regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit. We also provide the directors with a statement that we have complied with relevant ethical requirements regarding independence, and to communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, actions taken to eliminate threats or safeguards applied. From the matters communicated with the directors, we determine those matters that were of most significance in the audit of the financial report of the current period and are therefore the key audit matters. We describe these matters in our auditor’s report unless law or regulation precludes public disclosure about the matter or when, in extremely rare circumstances, we determine that a matter should not be communicated in our report because the adverse consequences of doing so would reasonably be expected to outweigh the public interest benefits of such communication. 48 49 Report on the Remuneration Report Opinion on the Remuneration Report We have audited the Remuneration Report included in pages 6 to 16 of the Directors’ Report for the year ended 30 June 2024. In our opinion, the Remuneration Report of Medical Developments International Limited, for the year ended 30 June 2024, complies with section 300A of the Corporations Act 2001. Responsibilities The directors of the Company are responsible for the preparation and presentation of the Remuneration Report in accordance with section 300A of the Corporations Act 2001. Our responsibility is to express an opinion on the Remuneration Report, based on our audit conducted in accordance with Australian Auditing Standards. DELOITTE TOUCHE TOHMATSU Melanie Sutton Partner Chartered Accountants Melbourne, 26 August 2024 27 to 41 50 51 Consolidated Statement of Profit or Loss and other Comprehensive Income For the year ended 30 June 2024 (1) Employee benefits expense includes $5.1 million share-based payment expense in the current year in relation to the cancellation of options granted to the CEO on commencement of his employment in FY21. The cancellation of options was approved at the 2023 AGM as part of the transition to new remuneration arrangements for the CEO. The expense recognised in the year is the unamortised amount of the fair value of the equity instruments (valued at the date the instruments were granted) that has not been recognised in the Consolidated Statement of Profit or Loss and Other Comprehensive Income in prior periods. This is a non-cash adjustment and does not represent a benefit to the CEO. The Consolidated Statement of Profit or Loss and Other Comprehensive Income should be read in conjunction with the accompanying notes. $’000 Notes 2024 2023 Revenue 1.1, 1.2 33,149 32,337 Contract termination revenue 1.1, 1.2 - 18,928 Raw materials and consumables used (8,783) (10,125) Employee benefits expense(1) (23,472) (21,615) Distribution expenses (2,822) (3,825) Regulatory and registration expenses (2,472) (2,969) Occupancy, selling and administration expenses (9,073) (10,963) Interest and other income 402 657 Depreciation and amortisation expense (3,394) (3,113) Impairment expense 1.1 (16,375) (6,709) Finance costs (86) (95) Loss before income tax expense (32,926) (7,492) Income tax (expense) / benefit 1.3 (8,066) 1,883 Net loss for the year (40,992) (5,609) Net loss attributable to equity holders of the parent entity (40,992) (5,609) Other comprehensive income Items that may be reclassified subsequently to profit or loss, net of tax Foreign currency translation (losses) / gains 78 (75) Total comprehensive loss for the year (40,914) (5,684) Total comprehensive loss attributable to equity holders of the parent entity (40,914) (5,684) cents Basic earnings / (loss) per share 1.1 (47.50) (6.66) Diluted earnings / (loss) per share 1.1 (47.50) (6.66) Consolidated Statement of Financial Position For the year ended 30 June 2024 $’000 Notes 2024 2023 CURRENT ASSETS Cash and cash equivalents 9,735 24,661 Trade and other receivables 2.1 7,071 8,932 Inventories 2.1 8,771 8,378 Prepayments 565 791 TOTAL CURRENT ASSETS 26,142 42,762 NON-CURRENT ASSETS Plant and equipment 2.3 10,162 12,122 Goodwill and other intangible assets 2.3 22,857 38,317 Deferred tax assets 1.3 - 8,112 TOTAL NON-CURRENT ASSETS 33,019 58,551 TOTAL ASSETS 59,161 101,313 CURRENT LIABILITIES Trade and other payables 2.1 8,254 14,186 Employee benefits provisions 4.1 639 727 Lease liabilities 2.5 371 352 Unearned income 2.2 283 283 TOTAL CURRENT LIABILITIES 9,547 15,548 NON-CURRENT LIABILITIES Employee benefits provisions 4.1 309 343 Unearned income 2.2 1,637 1,899 Lease liabilities 2.5 1,915 2,208 Deferred tax liabilities 1.3 19 - TOTAL NON-CURRENT LIABILITIES 3,880 4,450 TOTAL LIABILITIES 13,427 19,998 NET ASSETS 45,734 81,315 EQUITY Contributed equity 3.2 105,729 105,729 Reserves 3.2 2,864 5,740 Accumulated losses (62,859) (30,154) TOTAL EQUITY 45,734 81,315 The Consolidated Statement of Financial Position should be read in conjunction with the accompanying notes. 52 53 $’000 Contributed equity Accumulated losses Share based payments reserve CSIRO option reserve Foreign currency translation reserve Total equity Year ended 30 June 2024 As at 1 July 2023 105,729 (30,154) 3,940 1,866 (66) 81,315 Loss for the year - (40,992) - - - (40,992) Other comprehensive gain - - - - 78 78 Total comprehensive (loss) / income - (40,992) - - 78 (40,914) Share based payments expense - - 5,866(1) - - 5,866 Shares acquired by Employee Share Trust - - (533)(2) - - (533) Transfer from reserves to equity - 8,287 (8,287) - - - Transactions with owners in their capacity as owners - 8,287 (2,954) - - 5,333 Balance as at 30 June 2024 105,729 (62,859) 986 1,866 12 45,734 Year ended 30 June 2023 As at 1 July 2022 76,992 (24,545) 2,976 1,866 9 57,298 Loss for the year - (5,609) - - - (5,609) Other comprehensive loss - - - - (75) (75) Total comprehensive loss - (5,609) - - (75) (5,684) Share based payments expense - - 964 - - 964 Shares issued 30,000 - - - - 30,000 Equity raising costs (1,684) - - - - (1,684) Tax on equity raising costs 421 - - - - 421 Transactions with owners in their capacity as owners 28,737 - 964 - - 29,701 Balance as at 30 June 2023 105,729 (30,154) 3,940 1,866 (66) 81,315 (1) During the current year the CEO joined the Group’s long term incentive (LTI) program that was established in FY23, and was granted 617,620 performance rights with a target hurdle aligned to share price growth over a three year period. On acceptance of the invitation to join the LTI program, options previously held by the CEO were cancelled. These remuneration arrangements were approved at the 2023 AGM. The Group has recorded a $5.1 million share- based payment expense in the current year in relation to this cancellation. The expense recognised in the year is the unamortised amount of the fair value of the equity instruments (valued at the date the instruments were granted) that has not been recognised in the Statement of Profit or Loss and Other Comprehensive Income in prior periods. This is a non-cash adjustment and does not represent a benefit to the CEO. On cancellation, the total fair value of the options recognised in the share-based payment reserve of $8.3 million was transferred to accumulated losses. An additional share-based payment expense of $0.8 million was recognised in the year for other incentive programs and remuneration arrangements for the CEO and select executives who participate in these programs. (2) During the current year the Group purchased its own shares on market at a value of $0.5 million for the purpose of allocating these shares to eligible employees under the Group’s incentive plans and arrangements. As at 30 June 2024, all shares purchased on market have been issued to eligible employees. The above Consolidated Statement of Changes in Equity should be read in conjunction with the accompanying notes. $’000 Notes 2024 2023 CASH FLOWS FROM OPERATING ACTIVITIES Receipts from customers 34,762 29,075 Payments to suppliers and employees (45,746) (46,259) Receipts from government grants 34 218 Income tax paid (46) - Interest received 302 566 Interest paid (86) (95) Net cash flows used in operating activities 3.1 (10,780) (16,495) CASH FLOWS FROM INVESTING ACTIVITIES Payments for plant and equipment (793) (1,784) Payments for other intangible assets (2,376) (5,881) Net cash flows used in investing activities (3,169) (7,665) CASH FLOWS FROM FINANCING ACTIVITIES Proceeds from the issue of shares 3.2 - 30,000 Payment for shares acquired by the employee trust (533) - Share issue transaction costs 3.2 - (1,684) Repayment of lease liabilities 3.5 (274) (253) Net cash flows (used in) / generated by financing activities (807) 28,063 Net increase / (decrease) in cash and cash equivalents (14,756) 3,903 Cash and cash equivalents at the beginning of the year 24,661 20,398 Effect of exchange rate changes on cash and cash equivalents (170) 360 Cash and cash equivalents at the end of the year 9,735 24,661 The Consolidated Statement of Cash Flows should be read in conjunction with the accompanying notes. Consolidated Statement of Cash Flows For the year ended 30 June 2024 Consolidated Statement of Changes in Equity For the year ended 30 June 2024 54 55 NOTES TO THE FINANCIAL STATEMENTS Section 1 – Performance This section highlights the results and performance of the Group for the year ended 30 June 2024. 1.1 GROUP RESULTS MVP’s chief operating decision maker is the Group’s CEO. The Group’s CEO monitors results by reviewing the Group’s reportable segments from a product perspective as outlined in the table below: (1) Earnings before finance costs, net of interest income, tax, depreciation and amortisation and underlying adjustments. (2) Earnings before finance costs, net of interest income, tax and underlying adjustments. (3) Other comprises unallocated costs associated with corporate overheads, and in the prior period minor costs in relation to the Veterinary business which was discontinued during the 2022 financial year. (4) Excludes Contract termination revenue arising from the termination of agreements for the distribution of Penthrox in China ($18.5 million), and other countries where revenue opportunities are not being pursued ($0.4 million). A reconciliation between the Group’s segment information (which excludes underlying adjustments) and reported financial information as disclosed in the Consolidated Statement of Profit or Loss and Other Comprehensive Income is presented below. The financial information below reflects the segment results reported to and monitored by the CEO: Reportable Segments Products/Services Regions of Operation Pain Management The manufacture and sale of Penthrox® • Australia • Europe • Middle East • Canada • Asia • South Africa • United Kingdom Respiratory The sale of respiratory devices for use by sufferers of asthma and chronic obstructive pulmonary disease (COPD) • Australia • Europe • Canada • Asia • United Kingdom • USA Year ended 30 June 2023 Revenue(4) 20,448 11,720 169 32,337 Underlying EBITDA(1) (9,716) 1,498 (6,915) (15,133) Underlying EBIT(2) (12,299) 1,250 (7,197) (18,246) $’000 Pain Management Respiratory Other(3) Total Year ended 30 June 2024 Revenue 21,296 11,853 - 33,149 Underlying EBITDA(1) (1,139) 974 (8,072) (8,237) Underlying EBIT(2) (3,852) 762 (8,541) (11,631) Net loss after tax Set out below is a reconciliation between underlying EBITDA and net loss after tax as disclosed in the Consolidated Statement of Profit or Loss and Other Comprehensive Income: Earnings per share is calculated by dividing the net loss for the year attributable to ordinary equity holders of MVP by the weighted average number of ordinary shares outstanding during the year. Diluted earnings per share adjusts the figures used in the determination of basic earnings per share to include the weighted average number of additional ordinary shares that would have been outstanding assuming the conversion of all dilutive shares. This includes performance rights granted, CSIRO options and options granted to the CEO (until cancelled in the current year). (1) Share-based payment expense arising from the cancellation of options as part of the transition to new CEO remuneration arrangements approved by shareholders at the 2023 AGM. This is a non-cash adjustment and does not represent a benefit to the CEO. (2) Impairment of capitalised development costs relating to US market entry, including US market registration costs ($13.9 million) and development costs for the next generation device ($1.9 million), in the Pain Management segment. The prior year impairment charges relate to the cessation of registration activity in China ($5.7 million), and other countries ($0.9 million) where revenue opportunities are no longer being pursued. There was also a $0.1 million impairment in relation to patents and trademarks. (3) Impairment of redundant plant & equipment in the Pain Management segment. (4) Contract termination revenue arising from the termination of agreements for the distribution of Penthrox in China ($18.5 million), and other countries where revenue opportunities are not being pursued ($0.4 million). (5) Costs to complete a comprehensive commercial market assessment for Penthrox in the US. Basic and diluted earnings per share $’000 2024 2023 Earnings / (loss) per share (EPS) (cents) - Basic (47.50) (6.66) Earnings / (loss) per share (EPS) (cents) - Diluted (47.50) (6.66) Calculated using: • Net loss attributable to ordinary equity holders ($’000) (40,992) (5,609) • Weighted average of ordinary shares (shares) - Basic 86,305,215 84,274,349 • Weighted average of ordinary shares (shares) - Diluted 86,305,215 84,274,349 $’000 2024 2023 Underlying EBITDA (8,237) (15,133) Depreciation and amortisation expense (3,394) (3,113) Underlying EBIT (11,631) (18,246) Share based payment expense arising from cancellation of options(1) (5,136) - Impairment losses - Capitalised registration costs(2) (15,804) (6,709) Impairment losses - Plant & equipment(3) (571) - Contract termination revenue - Pain Management segment(4) - 18,928 Commercial Market Assessment Costs(5) - (1,930) Total underlying adjustments (21,511) 10,289 Reported EBIT (33,142) (7,957) Net interest 216 465 Net loss before tax (32,926) (7,492) Income tax (expense) / benefit (8,066) 1,883 Net loss after tax (40,992) (5,609) 56 57 1.2 REVENUE FROM CONTRACTS WITH CUSTOMERS Set out below is an overview of revenue from contracts with customers based on their geographic location: Disaggregation of revenue from contracts with customers (1) There are no sales between reportable segments. (2) The Group has no individual customers who contributed 10% or more to total revenue in the 2024 fiscal year (2023: nil). (3) Revenue from customers with contracts in the Pain Management segment includes deferred revenue from upfront and milestone payments (ROW) of $0.2 million (2023: $0.7 million, including ROW $0.5 million and Europe $0.2 million). (4) Other comprises the Veterinary business which was discontinued during the 2022 financial year. (5) Contract termination revenue arising from the termination of agreements for the distribution of Penthrox in China ($18.5 million), and other countries where revenue opportunities are not being pursued ($0.4 million). Year ended 30 June 2023 Australia 9,649 3,806 169 13,624 Europe 5,656 2,337 - 7,993 United States - 4,590 - 4,590 Rest of the World 5,143 987 - 6,130 Revenue(1)(2)(3) 20,448 11,720 169 32,337 Contract termination revenue(5) 18,928 - - 18,928 Total 39,376 11,720 169 51,265 $’000 Pain Management Respiratory Other(4) Total Year ended 30 June 2024 Australia 12,290 3,074 - 15,364 Europe 6,145 1,272 - 7,417 United States - 6,278 - 6,278 Rest of the World 2,861 1,229 - 4,090 Revenue(1)(2)(3) 21,296 11,853 - 33,149 How MVP accounts for revenue Sale of goods Revenue from the sale of goods is recognised when the Group has transferred control of the product to the buyer. The sole performance obligation relates to the delivery of the product with no after sales service embedded or attached to the underlying sale. Settlement and volume discounts granted to customers are accounted for as offsets against sales. Upfront and milestone income Revenue from upfront and milestone payments is recognised as deferred revenue (revenue received in advance) and amortised to profit or loss over the underlying contract term. As the performance obligation represents the provision of a time-based right for the Groups’ partners to exclusively sell product in a specific market, the consumption of the right and benefit occurs evenly over the contract period. If the agreement to which the payments relate is terminated or distribution is otherwise ceased, and there is no obligation to refund any of the amounts received, the deferred revenue will be recognised immediately in the Consolidated Statement of Profit and Loss and Other Comprehensive Income. The tax rate used in the above reconciliation is the corporate tax rate of 25% (2023: 25%) applicable to base rate entities under Australian tax law. (1)Non-deductible expenses in the current year primarily relates to share based payment expenses (2)Due to uncertainties with respect to the utilisation of tax losses in the future, the Group has derecognised from tax assets tax losses carried forward from prior periods of $13.7 million and has not recognised current year tax losses of $1.3 million as deferred tax assets. 1.3 TAXATION Reconciliation of income tax benefit $’000 2024 2023 Accounting loss before tax (32,926) (7,492) Income tax benefit calculated at 25% (2023: 25%) (8,232) (1,873) Research and development benefit (59) (106) Non-deductible expenses(1) 1,437 294 Current year tax losses not recognised 1,279 - Derecognition of prior period tax losses(2) 13,734 - Adjustments in respect of income tax of previous years (65) (124) Effect of different tax rates of subsidiaries in other jurisdictions (28) (74) Income tax expense / (benefit) 8,066 (1,883) Comprising of: Current year income tax expense (2,008) 741 Deferred income tax benefit (3,595) (2,500) Derecognition of prior period tax losses 13,734 - Adjustments in respect of income tax of previous years (65) (124) 58 59 $’000 2024 2023 Deferred tax assets Temporary differences 2,606 2,551 Tax losses 2,008 13,734 4,614 16,285 Deferred tax liabilities Temporary differences (4,633) (8,173) Net deferred tax (liability) / asset (19) 8,112 Recognised current and deferred tax assets and liabilities At the reporting date, the group has unused tax losses of $17.0 million available for offset against future profits. A deferred tax asset has been recognised in respect of $2.0 million of such losses to the extent they offset future taxable temporary differences. A deferred tax asset has not been recognised for the remaining unused tax losses of $15.0 million due to uncertainties with respect to the utilisation of tax losses in the future. The tax losses can be carried forward indefinitely. Set out below are the deferred tax assets and liabilities recognised by the Group and movements during the year: Year ended 30 June 2023 Deferred tax assets / (liabilities) Accrued expenses 201 885 1,086 Deferred revenue 5,422 (4,876) 546 Lease liabilities 703 (63) 640 Right of use assets (565) 68 (497) Other intangibles (8,262) 796 (7,466) Property, plant and equipment (126) 101 (25) Provisions 442 (163) 279 Brand names (185) - (185) Tax losses 7,982 5,752 13,734 5,612 2,500 8,112 Year ended 30 June 2024 Deferred tax assets / (liabilities) Accrued expenses 1,086 112 1,198 Deferred revenue 546 (66) 480 Lease liabilities 640 (68) 572 Right of use assets (497) 67 (430) Other intangibles (7,466) 3,473 (3,993) Property, plant and equipment (25) - (25) Provisions 279 77 356 Brand names (185) - (185) Tax losses 13,734 (11,726) 2,008 8,112 (8,131) (19) $’000 Opening balance Charged to income Closing balance How MVP accounts for taxation Income tax charges: • Comprise of current and deferred income tax charges and represent the amounts expected to be paid to and recovered from the taxation authorities in the jurisdictions that MVP operates. • Are recorded in Equity when the underlying transaction that the tax is attributable to is recorded within Other Comprehensive Income. MVP uses the tax laws in place or those that have been substantively enacted at reporting date to calculate income tax. For deferred income tax, MVP also considers whether these tax laws are expected to be in place when the related asset is realised or liability is settled. Management periodically re- evaluate their assessment of their tax positions, in particular where they relate to specific interpretations of applicable tax regulation. Deferred tax assets and liabilities are recognised on all assets and liabilities that have different carrying values for tax and accounting, including those arising from a single transaction, except for the initial recognition of goodwill. Specifically, for deferred tax assets: • They are recognised only to the extent that it is probable that there are sufficient future taxable amounts to be utilised against. This assessment is reviewed at each reporting date. • They are offset against deferred tax liabilities in the same tax jurisdiction, when there is a legally enforceable right to do so. Research and development (R&D) tax credits receivable as compensation for expenses or losses already incurred by the Group with no future related costs are recognised in profit or loss in the period in which they are quantified and become receivable. The Group applies the income tax approach for the accounting and presentation of the R&D tax credit. Accordingly, the tax benefit is presented as a reduction of income tax expense in the Statement of Profit or Loss and Other Comprehensive Income. The Group is not currently in the scope of the Pillar Two top up tax being implemented in Australia. Key Estimates and Judgements – Taxation The carrying amount of deferred tax assets are reviewed at the end of each reporting period and reduced to the extent that it is no longer probable that sufficient taxable profits will eventuate to enable recovery of the asset, or to the extent that the entity has sufficient taxable temporary differences. In assessing the recoverability of deferred tax assets in respect of tax losses, the Group considers the pattern of historical tax losses, and profit forecasts. The Group continues to recognise a deferred tax asset or deferred tax liability in relation to timing differences. Deferred tax assets Due to uncertainties with respect to the utilisation of tax losses in the future, the Group has derecognised $13.7 million of unused historical tax losses from prior periods and have not recognised $1.3 million of current year tax losses. The Group continues to recognise a deferred tax asset or deferred tax liability in relation to temporary differences and tax losses to the extent they offset future taxable temporary differences. 1.4 DIVIDENDS No interim or final dividend was paid in the current year (2023 nil). 60 61 Section 2 – Operating Assets and Liabilities This section highlights the primary operating assets used and liabilities incurred to support the Group’s operating activities. 2.1 WORKING CAPITAL Trade and other receivables Trade and other receivables at balance date comprise of: (1) Below is a breakdown of the ageing of trade receivables: The average credit period on sales of goods to domestic customers is 30 days, international customers 60 days. No interest is charged on trade receivables. The Group has a number of mechanisms in place which assist in minimising financial losses due to customer non- payment. These include: • all customers who wish to trade on credit terms are subject to strict credit verification procedures, which may include an assessment of their independent credit rating, financial position, past experience and industry reputation; • individual risks limits, which are regularly monitored in-line with set parameters; and • monitoring receivable balances on an ongoing basis. Expected credit loss model Information about the credit risk exposure on the Group’s trade receivables using a provision matrix has not been disclosed due to the immaterial amount of expected credit losses as at 30 June 2024. Ageing of trade receivables as at 30 June ($’000) $’000 2024 2023 Trade receivables(1) 6,973 8,769 Allowance for expected credit losses (17) - Other receivables 115 163 Total current trade and other receivables 7,071 8,932 0-30 30-60 4,509 6,936 1,711 1,273 524 212 371 61-90 >90 Days 2024 2023 189 How MVP accounts for trade and other receivables MVP’s trade receivables are non-interest bearing, are initially recorded at fair value and include Goods and Services Tax (GST). Trade receivables are subsequently measured at amortised cost using the effective interest method, less and allowance for expected credit losses. The Group assesses the expected credit losses associated with its trade and other receivables on a forward-looking basis. The Group applies the simplified approach to measuring expected credit losses, which requires expected lifetime losses to be recognised from initial recognition of the receivables. To measure the expected credit losses, trade and other receivables that share similar credit risk characteristics and days past due are grouped and then assessed for collectability as a whole. The Group continues to assess the risk of non-recoverability or expected credit loss on its receivables to be very low. Trade receivables are typically collected within a 30-90-day period and despite the occasional debtor being slow paying, empirical evidence suggests there has been a very low level of credit losses in previous years. How MVP accounts for inventories Inventories are valued at the lower of cost and net realisable value. Costs, including an appropriate portion of fixed and variable overhead expenses, are assigned to inventory on hand by the method most appropriate to each particular class of inventory (all being valued on a first in first out basis). Net realisable value represents the estimated selling price less all estimated costs of completion and costs to be incurred in marketing, selling and distribution. How MVP accounts for Trade and other payables Trade and other payables are carried at their principal amounts, are not discounted and include GST. They represent amounts owed for goods and services provided to the Group prior to, but were not paid for, at the end of the financial year. The amounts are generally unsecured and are usually paid within 30 – 90 days of recognition. Inventories Inventories at balance date comprise of: Trade and other payables Current trade and other payables at balance date comprise of: There is no interest is charged on trade payables. The Group has financial risk management policies in place to ensure that all payables are paid within the credit timeframe. $’000 2024 2023 Raw materials 1,889 2,414 Work in progress 1,451 2,932 Finished goods 5,431 3,032 Total inventories 8,771 8,378 $’000 2024 2023 Trade payables 8,254 13,324 Other payables - 862 Total current trade and other payables 8,254 14,186 62 63 2.2 UNEARNED INCOME Unearned income at balance date comprise of: (1) Unearned income represents upfront unamortised payments in relation to licensing and distribution agreements for Penthrox®. These non-refundable payments are deferred and amortised over the term of the agreement to which the payments relate, or immediately if the agreement is terminated or distribution is otherwise ceased. (2) Unearned government grant income represents funds received through the Commercial Ready Programme from the Federal Government, Futures Industries Manufacturing Program of the Victorian State Government and various other government funding initiatives. 2.3 NON-CURRENT ASSETS Property, plant and equipment The key movements over the year were as follows: $’000 2024 2023 Revenue received in advance(1) 1,595 1,792 Unearned government grant income(2) 325 390 Total unearned income 1,920 2,182 Current 283 283 Non-current 1,637 1,899 $’000 Leasehold improvements Plant and equipment(1) Right of use asset Total Estimated useful life 5-10 years 4-12 years 4-12 years Year ended 30 June 2024 At 1 July 2023 net of accumulated depreciation 196 9,936 1,990 12,122 Additions 3 447 - 450 Impairment - (571) - (571) Depreciation charge for the year (36) (1,531) (272) (1,839) At 30 June 2024 net of accumulated depreciation 163 8,281 1,718 10,162 Represented by: • at cost 354 19,276 3,074 22,704 • Accumulated depreciation (191) (10,995) (1,356) (12,542) Year ended 30 June 2023 At 1 July 2022 net of accumulated depreciation 158 9,133 2,261 11,552 Additions 10 2,113 - 2,123 Transfers 62 (62) - - Depreciation charge for the year (34) (1,248) (271) (1,553) At 30 June 2023 net of accumulated depreciation 196 9,936 1,990 12,122 Represented by: • at cost 351 18,829 3,074 22,254 • Accumulated depreciation (155) (8,893) (1,084) (10,132) (1) Includes capital works in progress of $0.3 million (2023: $1.6 million). Key Estimates and Judgements Estimation of useful lives of assets The estimation of the useful lives of assets, excluding the right-of-use (ROU) assets, is based on historical experience. In addition, the condition of the assets is assessed each reporting period and considered against the remaining useful life. Adjustments to useful lives are made when considered necessary. The estimation of the useful lives of ROU assets is based on the non-cancellable period of the lease plus renewal options when the exercise of the option is considered to be reasonably certain. Key Estimates and Judgements Recoverability of property, plant and equipment The Group assesses impairment of all assets at each reporting date by evaluating conditions specific to the Group and to the particular asset that may lead to impairment. These include product and manufacturing performance, technology, social, economic and political environments and future product expectations. If an impairment trigger exists, the recoverable amount of the asset is determined to assess if any impairment is required. How MVP accounts for property plant and equipment Property, plant and equipment is stated at cost less accumulated depreciation and any accumulated impairment losses. Cost includes expenditure directly attributable to the acquisition of the item and subsequent costs incurred to replace parts that are eligible for capitalisation. Depreciation is calculated on a straight-line basis over the estimated useful life of the assets. ROU assets are measured at cost comprising the following: • the amount of the initial measurement of lease liability; • any lease payments made at or before the commencement date less any lease incentives; • any initial direct costs; and • estimated restoration costs. ROU assets are subsequently measured at cost less accumulated depreciation and impairment losses, with depreciation recognised on a straight-line basis over the lease term. The Group assesses at each reporting date whether there is an indication that an asset with a finite life may be impaired. If any such indication exists, the Group makes an estimate of the asset’s recoverable amount. An asset’s recoverable amount is the higher of its fair value less costs to sell and its value in use and is determined for an individual asset, unless the asset generates cash inflows that are largely dependent on those from other assets or groups of assets and the asset’s value in use cannot be estimated to approximate its fair value. In such cases the asset is tested for impairment as part of the CGU to which it belongs. When the carrying amount of an asset or CGU exceeds its recoverable amount, the asset or CGU is considered impaired and is written down to its recoverable amount. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset. Impairment losses are recognised in the Consolidated Statement of Profit or Loss and Other Comprehensive Income. An assessment is also made at each reporting date as to whether there is any indication that previously recognised impairment losses may no longer exist or may have decreased. If such an indication exists, the recoverable amounts are estimated. A previously recognised impairment loss is reversed only if there has been a change in the estimates used to determine the asset’s recoverable amount since the last impairment loss was recognised. If this is the case the carrying amount of the asset is increased to its recoverable amount. The increased amount cannot exceed the carrying amount that would have been determined, net of depreciation, had no impairment loss been recognised for the asset in prior years. 64 65 Goodwill and other intangibles Goodwill and other intangible assets are comprised of the following: (1) The carrying value for capitalised registration costs across regions comprises: Europe $15.9 million, other countries $0.1 million (2023: Europe $16.2 million, USA $13.5 million, other countries $0.2 million) (2) Other intangibles include Brand names of $738,000 with an indefinite life (2023: $738,000) (3) The Group announced in April 2024 it is pausing activity on US market entry, however, there remains a strategic intent to pursue market entry in the future. Subsequently the Group has recognised an impairment of capitalised development costs in the current year relating to the US market entry, including US market registration costs ($13.9m) and development costs for the next generation device ($1.9m). The impairment loss was recognised in the Pain Management segment. (4) The impairment loss recognised in the prior year relates to the write down of capitalised registration costs in the Pain Management segment after the Group ceased registration activity in China ($5.7 million), and other countries ($0.9 million), and a $0.1 million impairment in relation to patents and trademarks. $’000 Development Patents and trademarks Capitalised registration costs(1) Other(2) intangibles Goodwill Total Year ended 30 June 2024 At 1 July 2023 net of accumulated amortisation and impairment 2,848 1,053 29,853 755 3,808 38,317 Additions 321 319 1,259 - - 1,899 Impairment(3) (1,851) - (13,953) - - (15,804) Amortisation (313) (123) (1,119) - - (1,555) At 30 June 2024 net of accumulated amortisation and impairment 1,005 1,249 16,040 755 3,808 22,857 Represented by: • At cost 10,315 2,409 46,180 755 9,095 68,754 • Accumulated amortisation and impairment (9,310) (1,160) (30,140) - (5,287) (45,897) Year ended 30 June 2023 At 1 July 2022 net of accumulated amortisation and impairment 2,411 999 32,714 755 3,808 40,687 Additions 673 298 4,928 - - 5,899 Impairment(4) - (112) (6,597) - - (6,709) Amortisation (236) (132) (1,192) - - (1,560) At 30 June 2023 net of accumulated amortisation and impairment 2,848 1,053 29,853 755 3,808 38,317 Represented by: • At cost 9,994 2,090 44,921 755 9,095 66,855 • Accumulated amortisation and impairment (7,146) (1,037) (15,068) - (5,287) (28,538) Goodwill has been allocated to the following CGU’s: $’000 2024 2023 Pain Management 3,808 3,808 Respiratory - - 3,808 3,808 66 67 How MVP accounts for intangible assets Goodwill Goodwill, representing the excess of the cost of acquisition over the fair value of the identifiable net assets acquired, is recognised as an asset and not amortised but tested for impairment annually and whenever there is an indication that the goodwill may be impaired. Any impairment loss is recognised immediately in the Consolidated Statement of Profit or Loss and Other Comprehensive Income and is not subsequently reversed. Patents, trademarks and licenses Patents, trademarks and licenses are recorded at cost less accumulated amortisation and impairment. Amortisation is charged on a straight-line basis over their estimated useful lives of 10 years. The estimated useful life and amortisation method is reviewed at the end of each annual reporting period. The carrying value of patents, trademarks and licenses is reviewed at each reporting date for indicators of impairment. Any impairment loss is recognised as an expense in the Consolidated Statement of Profit or Loss and Other Comprehensive Income. Registration costs Registration costs relate to costs incurred to obtain registration for Penthrox® in a geographic region. Registration costs are recognised as an intangible asset if, and only if, all of the following are demonstrated: • the technical feasibility of completing the intangible asset so that it will be available for use or sale; • the intention to complete the intangible asset and use or sell it; • the ability to use or sell the intangible asset; • how the intangible asset will generate probable future economic benefits; • the availability of adequate technical, financial and other resources to complete the development and to use or sell the intangible asset; and • the ability to reliably measure the expenditure attributable to the asset during its development. An assessment is made at each reporting date as to whether the key recognition criteria is met. If the recognition criteria is not met, development expenditure is expensed as incurred. Expenditure on research activities is also expensed as incurred. Methoxyflurane, which is the active ingredient in Penthrox® , has been used for acute analgesia in Australia for more than 40 years. The Group has successfully registered methoxyflurane in over 40 countries, requiring varying levels of documentation and clinical evidence to meet the requirements of regulatory bodies. The Group has historically capitalised registration costs as an intangible asset on the basis that it is seeking registration for a product with an established history of use in Australia and various International markets, which supports the Group in meeting the recognition criteria under AASB 138 Intangible Assets, in particular the technical feasibility of achieving registration and the probability of generating future economic benefits. The amounts capitalised comprise directly attributable costs, including: • The cost of preclinical and clinical trials (principally external costs) • Employee benefits directly attributable to achieving registration within a geographic region Registration costs are recorded at cost less accumulated amortisation and impairment. Amortisation is charged on a straight-line basis over the estimated useful life of the asset (10 years), commencing from the date that registration is achieved and the Group commences generating economic benefits from the relevant geography. Costs capitalised for registrations in progress are not amortised and are assessed for impairment annually or when an indicator of impairment is identified. Product and technology development costs Product and technology development costs principally include developments costs associated with the development of new devices. Product and technology development costs are recognised as an intangible asset if, and only if, they meet the recognition criteria under AASB 138 Intangible Assets, as set out above in the accounting policy for “registration costs”. If the recognition criteria is not met, development costs are expensed as incurred. Expenditure on research activities is also expensed as incurred. Product and technology development costs are recorded at cost less accumulated amortisation and impairment. Amortisation is charged on a straight-line basis over the estimated useful life of the asset (5 - 10 years), commencing from the date that development activities are completed and the Group commences generating economic benefits. Developments in progress are not amortised. Brand names Brand names arising on acquisition of a business are initially recognised at Fair Value and subsequently carried at cost less any applicable impairment charge (if any). They are not amortised but subject to annual tests for impairment. For the purposes of impairment testing, brand names are allocated to the relevant cash generating unit to which they relate. Any impairment loss is recognised as an expense in the Consolidated Statement of Profit or Loss and Other Comprehensive Income. Key Estimate and Judgement Impairment of goodwill and other intangibles Determining whether goodwill is impaired requires an estimation of the recoverable amount of the cash-generating units to which goodwill has been allocated. The recoverable amount calculation requires the entity to estimate the future cash flows expected to arise from the cash generating unit and a suitable discount rate in order to calculate the present value of those cash flows. Key Estimate and Judgement Impairment of intangible assets not yet available for use The Group has material capitalised registration costs in relation to obtaining registration of Penthrox® in a number of jurisdictions (primarily the USA). Management tests these capitalised costs for impairment annually and where an impairment indicator is identified. The recoverability of these costs is ultimately contingent upon achieving registration in these jurisdictions. 68 69 Impairment of capitalised registration costs During the year the Group completed a review of the carrying value of assets in accordance with the Group’s accounting policy and accounting standards. As a result, the Group recognised an impairment of capitalised development costs relating to US market entry, including US market registration costs of $13.9 million and development costs for the next generation device of $1.9 million. The write-down of US market entry development costs followed the Company announcement in April 2024 to pause investment in US expansion plans. The Group currently does not meet the criteria under AASB 138 Intangible assets to maintain the capitalised development costs as an asset in the Statement of Financial Position. The Director’s view the impairment charge does not reflect the inherent value of the work completed to date, and it may be reversed when development is re-commenced. Annual impairment testing Goodwill and intangible assets not yet available for use are tested for impairment annually and whenever there is an indication that the asset may be impaired. Recoverable amount is the higher of fair value less costs to sell and value in use. In estimating the recoverable amount of an asset (or cash-generating unit), its estimated future cash flows are discounted to their present value using a post-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset for which the estimates of future cash flows have not been adjusted. If the recoverable amount of an asset (or cash- generating unit) is estimated to be less than its carrying amount, the carrying amount of the asset (or cash-generating unit) is reduced to its recoverable amount. An impairment loss is recognised in the Consolidated Statement of Profit or Loss and Other Comprehensive Income immediately. An impairment of goodwill is not subsequently reversed. Where an impairment loss (other than goodwill) subsequently reverses, the carrying amount of the asset (or cash generating unit) is increased to the revised estimate of its recoverable amount, but only to the extent that the increased carrying amount does not exceed the carrying amount that would have been determined had no impairment loss been recognised for the asset (or cash-generating unit) in prior years. A reversal of an impairment loss is recognised in profit or loss immediately. The results of the Group’s impairment testing (now excluding the US region) for the year ended 30 June 2024 are set out as follows: Pain Management The recoverable amount for CGUs in the Pain Management segment was calculated using a ‘value in use’ approach, which incorporates cash flow projections over ten years, and a terminal value, discounted to present value using a risk-adjusted post- tax discount rate. The Group has modelled cash flow over a period greater than 5 years given the scale-up phase the Group is in. This approach enables the Group to model expected growth before it reaches a level of maturity in its terminal value. No impairment loss was identified as a result of impairment testing performed. The recoverable amount for Pain Management represents an estimate of future cash flows attributable to the geographies in which the Group currently operates, allowing for further growth and expansion, using the Board approved Budget for year 1, revenue growth in accordance with the business operating plan for years 2-10 and a terminal growth rate of 2.0% (2023: 2.0%). The estimate of future cash flows was then discounted using a post-tax discount rate of 17.6% (2023: 15.0%). No future cash flows have been included for the US region following the decision in April to pause investment in US market entry. The cashflows attributable to the geographies in which the Group currently operates (principally Australia and Europe) reflect continued growth. The Group believes that the assumptions adopted in the recoverable amount calculations reflect an appropriate balance between the Group’s experience to date and the Group’s long-term growth expectations for the Pain Management business. 70 71 2.4 COMMITMENTS AND CONTINGENCIES Capital expenditure commitments There were no material capital expenditure commitments at the end of the year (2023: nil). Contingencies The Group is not party to any legal proceedings that are expected, individually or in the aggregate, to have a material adverse effect on its business, financial position or operating results. 2.5 LEASES The lease liabilities included in the consolidated statement of financial position are: How MVP accounts for provisions and contingencies Provisions are recognised when the following three criteria are met: • the Group has a present obligation (legal or constructive) as a result of a past event; • it is probable that an outflow of resources embodying economic benefits will be required to settle the obligation; and • a reliable estimate can be made of the amount of the obligation When these criteria cannot be met, a contingency may be recognised. Provisions are measured at the present value of management’s best estimate of the expenditure required to settle the present obligation at the reporting date. The discount rate used to determine the present value reflects current market assessments of the time value of money and the risks specific to the liability. When discounting is used, the increase in the provision due to the passage of time is recognised as a financing cost. When some or all of the economic benefits required to settle a provision are expected to be recovered from a third party, the receivable is recognised as an asset if it is probable that recovery will be received and the amount of the receivable can be measured reliably. How MVP accounts for Leases The Group recognises a ROU asset and corresponding lease liability with respect to all lease agreements in which it is the lessee, except for short-term leases and leases of low value assets. Payments associated with short-term leases and leases of low-value assets are recognised on a straight-line basis as an expense in profit or loss. Short-term leases are leases with a lease term of 12 months or less. Lease liabilities Lease liabilities are initially measured at the present value of the lease payments that are not paid at the commencement date, discounted by using the rate implicit in the lease. If this rate cannot be readily determined, the Group uses its incremental borrowing rate. Each lease payment is allocated between the lease liability and finance costs. The finance cost is charged to profit or loss over the period of the lease to produce a constant periodic rate of interest on the remaining balance of the liability for each period. The carrying amount of a lease liability is remeasured if there is a modification, a change in the lease term, a change in the lease payments (e.g. inflation-linked payments or market rate rent reviews). A corresponding adjustment is made to the ROU asset. $’000 2024 2023 Current 371 352 Non-current 1,915 2,208 2,286 2,560 Section 3 – Capital Structure This section details specifics of the Groups’ capital structure. When managing capital, Management’s objective is to ensure that the Group continues as a going concern as well as to provide optimal returns to shareholders and other stakeholders. Management also aims to maintain a capital structure that ensures the lowest cost of capital available to the Group. Primary responsibility for identification and control of capital and financial risks rests with the Board of Directors. 3.1 NET CASH Reconciliation of net loss for the year to net cash flows from operations The Group had no borrowings as at 30 June 2024 (2023: nil) and was in a net cash position. $’000 2024 2023 Net loss for the year (40,992) (5,609) Non cash flows in the operating loss: Depreciation and amortisation 3,394 3,113 Share based payments expense 5,943 964 Impairment expense 16,375 6,709 Contract termination revenue - (18,928) Net unrealised foreign exchange (gain) / loss 320 (246) Changes in assets and liabilities: Decrease / (increase) in trade and other receivables 1,861 (2,870) Increase in inventory (393) (1,842) Decrease / (increase) in net deferred tax assets and liabilities 8,131 (1,883) (Decrease) / increase in trade and other payables (5,261) 4,830 (Decrease) / increase in employee benefit provisions (122) 18 Decrease / (increase) in other assets 226 (172) Deferred revenue realised (262) (579) Net cash flows used in operating activities (10,780) (16,495) How MVP accounts for cash and cash equivalents Cash and cash equivalents in the Consolidated Statement of Financial Position comprise cash at bank and on hand and short-term deposits with a maturity of twelve months or less that are readily convertible to known amounts of cash and which are subject to an insignificant risk of change in value. For the purposes of the Consolidated Statement of Cash Flows, cash and cash equivalents consist of cash and cash equivalents as defined above, net of bank overdraft balances. Bank overdrafts are included within interest-bearing loans and borrowings in current liabilities on the Consolidated Statement of Financial Position. Cash flows are included in the Consolidated Statement of Cash Flows on a gross basis and the GST component of cash flows arising from investing and financing activities which is recoverable from, or payable to, the taxation authority are classified as operating cash flows. 72 73 3.2 CONTRIBUTED EQUITY AND RESERVES Terms, conditions and movements of contributed equity Ordinary shares are classified as equity. Ordinary shares entitle the holder to participate in dividends and the proceeds on winding up of the Company in proportion to the number of shares held. Reserves (1) The foreign currency translation reserve is used to record foreign exchange fluctuations arising from the translation of the financial statements of foreign subsidiaries (based in the United Kingdom and Netherlands). Exchange differences arising on the translation from functional currencies to the Group’s presentation currency (Australian dollars) are recognised directly in other comprehensive income and accumulated in the foreign currency translation reserve. (2) The share-based payments reserve relates to performance rights granted by the Company to the CEO and select senior executives, and the equity settled component of the short term incentive plan for the CEO and select senior executives. (3) The CSIRO option reserve relates to 392,308 options (2023: 392,308) over ordinary shares of the Company. These options are in relation to the MVP/CSIRO Manufacturing Technologies Project announced on 5 June 2017, the final grant of options under this project was completed in the prior year. Options are exercisable for no consideration when a developed technology has been proven to be commercially viable. The share options granted to the CSIRO carry no rights to dividends and no voting rights. $’000 2024 2023 Foreign currency translation reserve(1) 12 (66) Share-based payments reserve(2) 986 3,940 CSIRO option reserve(3) 1,866 1,866 Total reserves 2,864 5,740 2024 2023 Number of shares $’000 Number of shares $’000 Movements in contributed equity Ordinary shares: Beginning of the year 86,305,175 105,729 71,305,057 76,992 Share placement options exercised 44(1) - - - Issuance of shares Share placement - - 15,000,118(1) 30,000 Share issuance costs - - - (1,684) Tax on share issuance costs - - - 421 End of the year 86,305,219 105,729 86,305,175 105,729 How MVP accounts for contributed equity Issued and paid up capital is classified as contributed equity and recognised at the fair value of the consideration received by the entity. Incremental costs directly attributable to the issue of new shares or options are shown in contributed equity as a deduction, net of tax, from the proceeds. (1) On 4 August 2022 the Company announced a fully underwritten placement and entitlement offer to raise $30 million. The placement and entitlement offer was successfully completed in August 2022. Under the placement, 5,999 options were offered to investors (one free option for every 2.5 shares). On 3 August 2023 a total of 44 options were exercised and converted to fully paid shares at a price of $2.80. 3.3 CAPITAL MANAGEMENT The Board of Directors manages the capital of the Group to ensure that it will be able to continue as a going concern while maximising the return to stakeholders. The Group does not enter into trade financial instruments, including derivatives, for speculative purposes. The capital structure of the Group consists of net cash as detailed in note 3.1 and the equity of the Group (comprising issued capital, reserves and accumulated losses). As at 30 June 2024 the Group had no borrowings, and was in a net cash position. 3.4 GOING CONCERN The financial report has been prepared on the going concern basis, which assumes continuity of normal business activities and the realisation of assets and the settlement of liabilities in the ordinary course of business. During the current year the Group incurred a net loss after tax of $41.0 million, used net cash in operating activities of $10.8 million and used net cash in investing activities of $3.2 million. As at 30 June 2024 the Group had $9.7 million of cash (30 June 2023: $24.7 million), net current assets of $16.6 million (30 June 2023: $27.2 million), and net assets of $45.7 million (30 June 2023: $81.3 million). Subsequent to year-end, the Group announced a fully underwritten capital raise of $10 million comprising an institutional placement and non-renounceable entitlement offer to accelerate growth and improve balance sheet strength. The institutional component of the placement was completed on 30 July 2024 with gross proceeds of $6.9m being received. The entitlement offer closed on 22 August 2024, with gross proceeds of $3.1 million expected to be received on 27 August 2024. The Group’s nearer term strategic focus is to increase the penetration of Penthrox in existing markets, and to continue to grow its Respiratory segment through market share gains, particularly in the USA. Longer term the Group seeks to enter new and attractive markets for Penthrox. The Group has prepared a cash flow forecast that supports the ability of the Group to continue as a going concern. The Group expects operating cashflows in FY25 to be improved on FY24, driven by higher pricing and operational efficiencies of $3-4 million from initiatives implemented in FY24. The Directors are satisfied that the Group’s cash position will enable the Group to pay its debts as and when they fall due for a period of no less than 12 months from the date the financial report was approved. 3.5 MANAGING OUR FINANCIAL RISKS There are a number of financial risks the Group is exposed to that could adversely affect the achievement of future business performance. The Group’s risk management program seeks to mitigate risks and reduce volatility in the Group’s financial performance. Financial risk management is managed by the Audit and Risk Committee. The Group’s principal financial risks are: • Liquidity risk; • Credit risk; and • Foreign currency risk. Managing liquidity risk Liquidity risk arises from the financial liabilities of the Group and the Group’s ability to meet its obligations to repay these financial liabilities as and when they fall due. The Group has a range of liabilities at balance date that will be required to be settled at some future date. What is the risk? The risk that MVP cannot meet its obligations to repay its financial liabilities as and when they fall due. How does MVP manage this risk? • Maintaining adequate cash reserves and borrowing facilities. • Continuously monitoring forecast and actual cash flows and matching the maturity profiles of financial assets and liabilities. Impact at 30 June 2024 The FY24 Financial statements have been prepared on a going concern basis. The Directors have assessed that the cash reserves at 30 June 2024, in addition to the cash inflows arising from the completion of the successful share placement and entitlement offer in August 2024, will provide the Group sufficient capacity to meet its debts as and when they fall due for a period of no less than 12 months from the date these financial statements were approved (refer note 3.4). 74 75 The Group’s financial instruments comprise cash, trade and other receivables, trade and other payables and lease liabilities. The Group does not hold any financial instruments that are measured subsequent to initial recognition at fair value. The table below summarises the maturity profile of the Group’s financials liabilities based on contractual undiscounted payments: The following table represents the changes in financial liabilities arising from financing activities: Managing credit risk Credit risk represents the loss that would be recognised if counterparties failed to meet their obligations under a contract or arrangement. The Group has adopted a policy that customers who wish to trade on credit terms, will be subject to strict credit verification procedures (refer note 2.1). The Group’s exposure is continually monitored, with trade receivables consisting of a large number of customers. The Group evaluates the concentration of risk with respect to trade receivables and contract assets as low as its customers are located in several jurisdictions and industries and operate in largely independent markets. $’000 Less than 1 year 1–5 years More than 5 years Total Year ended 30 June 2024 Financial liabilities Trade and other payables 8,254 - - 8,254 Lease liabilities 371 1,609 582 2,562 8,625 1,609 582 10,816 Year ended 30 June 2023 Financial liabilities Trade and other payables 14,186 - - 14,186 Lease liabilities 359 1,558 1,004 2,921 14,545 1,558 1,004 17,107 $’000 1 July 2023 Cash Flows 30 June 2024 Lease liabilities 2,560 (274) 2,286 Total liabilities from financing activities 2,560 (274) 2,286 $’000 1 July 2022 Cash Flows 30 June 2023 Lease liabilities 2,813 (253) 2,560 Total liabilities from financing activities 2,813 (253) 2,560 76 77 Managing foreign currency risk The Group’s exposure to the risk of changes in foreign exchange rates relates to the Group’s (i) operating activities which are denominated in a different currency from the entity’s functional currency and (ii) net investments in foreign subsidiaries. The Group currently operates through entities in three countries outside of Australia, with the following functional currencies: As the Group has an Australian dollar (AUD) presentation currency, which is also the functional currency of its Australian entities, this exposes the Group to foreign exchange rate risk. Country of Domicile Functional Currency United Kingdom GBP Netherlands EURO USA USD What is the risk? How does MVP manage this risk? Impact at 30 June 2024 If transactions are denominated in currencies other than the functional currency of the operating entity, there is a risk of an unfavourable financial Impact to earnings if there is an adverse currency movement. The Group does not currently consider its exposure to foreign currency to be significant and as such forward contracts and currency swap agreements are not used. The Group expects to become increasingly exposed to the Euro as it’s Penthrox® European expansion progresses in coming years and will monitor the exposure accordingly. Sensitivity analysis of the foreign currency net transactional exposures was performed to movements in the Australian dollar against the relevant foreign currencies, with all other variables held constant. This analysis includes only outstanding foreign currency denominated monetary items and adjusts their translation at the period end for a 10% change in foreign currency rates. This analysis showed that a 10% movement in its major trading currencies would not materially impact net loss after tax. As MVP has entities that do not have an Australian dollar (AUD) functional currency, if currency rates move adversely compared to the AUD, then the amount of AUD-equivalent profit would decrease, and the balance sheet net investment value would decline. The Group does not currently consider its exposure to foreign currency to be significant. The Group expects to expand in countries outside of Australia in future years and will monitor its exposure accordingly. Sensitivity analysis performed by management showed that a 10% +/- movement in its major translational currencies as at 30 June 2024 would not have a significant impact on equity and net loss before tax. How MVP accounts for foreign currency transactions Transactions in foreign currencies are initially recorded in the functional currency of the individual entity by applying the exchange rates ruling at the date of the transaction. Monetary assets and liabilities denominated in foreign currencies are retranslated at the rate of exchange prevailing at reporting date. Non-monetary items that are measured at: • Historical cost in a foreign currency are translated using the exchange rate as at the date of the initial transaction. • Fair value in a foreign currency are translated using the exchange rates at the date when the fair value was determined. As at the reporting date the assets and liabilities of the controlled entities with non-Australian dollar functional currencies are translated into the presentation currency of MVP at the rate of exchange at the reporting date and their statements of comprehensive income are translated at the weighted average exchange rate for the year (where appropriate). The exchange rate differences arising on the translation to presentation currency are taken directly to the foreign currency translation reserve, in equity. On disposal of a foreign entity, the deferred cumulative amount recognised in equity relating to that particular foreign operation is recognised in the Consolidated Statement of Comprehensive Income. 78 79 were cancelled. Select senior executives also participate in the program, in total they were granted 1,031,743 performance rights during the year. The program has a performance hurdle linked to growth in the share price over a three year vesting period. Details in relation to performance hurdles and vesting conditions are outlined in section 3 of the 2024 Remuneration Report. The rights were independently valued to establish fair value in accordance with AASB 2 Share Based Payments. The key assumptions used in the independent valuation are outlined in the table below. Performance rights The table below shows the movement in performance rights holdings during the year, and the balance of vested and unvested rights at the end of the financial year. Ordinary shares under option The table below shows the movement for ordinary shares under option during the current year. 4.2 SHARE BASED PAYMENTS Long term incentive plan During the current period the CEO joined the Group’s long-term incentive (LTI) program and was granted 617,620 performance rights. On acceptance of the invitation to join the LTI program, options previously held by the CEO Section 4 – Remunerating Our People This section provides financial insight into employee reward and recognition designed to attract, retain, reward and motivate high performing individuals so as to achieve the objectives of the Group, in alignment with the interests of its shareholders. This section should be read in conjunction with the Remuneration Report, contained within the Directors Report, which provides specific details on the setting of remuneration for Key Management Personnel. 4.1 EMPLOYEE BENEFITS The Group’s employee benefits expenses for the year were as follows: (1) Share based payments expense includes $5.1 million in the current year in relation to the cancellation of options granted to the CEO on commencement of his employment in FY21. The cancellation of options was approved at the 2023 AGM as part of the transition to new remuneration arrangements for the CEO. The expense recognised in the year is the unamortised amount of the fair value of the equity instruments (valued at the date the instruments were granted) that has not been recognised in the Consolidated Statement of Profit or Loss and Other Comprehensive Income in prior periods. This is a non-cash adjustment and does not represent a benefit to the CEO. The Group’s current employee benefits provisions relate to annual leave entitlements of $639,000 (2023: $727,000). The non-current employee benefits provisions relate to long service leave entitlements of $309,000 (2023: $343,000). $’000 2024 2023 Payroll and other employee benefits expense 15,001 14,177 Superannuation contributions 1,306 1,427 Share based payments expense(1) 5,866 964 Contracted employee expense 1,299 5,047 Total employee benefits expense 23,472 21,615 How MVP accounts for employee benefits Provision is made for employee benefits accumulated as a result of employees rendering services up to the reporting date. These benefits include wages and salaries, annual leave and long service leave. Benefits expected to be settled within twelve months of the reporting date are classified as current and are measured at their nominal amounts based on remuneration rates which are expected to be paid when the liability is settled. The liability for long service leave is recognised and measured as the present value of expected future payments to be made in respect of services provided by employees up to the reporting date using the projected unit credit method. Under this method consideration is given to expected future wage and salary levels, experience of employee departures, and periods of service. Expected future payments are discounted using market yields at the reporting date on national government bonds (except for Australia where high quality corporate bond rates are used in accordance with the standards) with terms to maturity and currencies that match, as closely as possible, the estimated future cash outflows. No options were exercised during the current year (2023: No options exercised). On acceptance of the invitation to join the LTI program, options previously held by the CEO were cancelled. How MVP accounts for share based payments Equity-settled share-based payments granted are measured at fair value at the date of grant. The fair value determined at the grant date of the equity-settled share-based payments is expensed on a straight-line basis over the vesting period, with a corresponding increase in equity. On the cancellation of equity instruments, the remaining unamortised amount of the fair value of the equity instruments will be expensed in the period in which the cancellation occurs. At the end of the reporting period, the Group revises its estimate of the number of equity instruments expected to vest and the impact of any revision on the original estimates is also recognised in the profit and loss. Balance at 1 July 2023 Number granted Balance at 30 June 2024 Vested at 30 June 2024 Unvested at 30 June 2024 CEO - 617,620 617,620 - 617,620 CFO 84,930 152,285 237,215 - 237,215 Executives 339,828 879,458 1,219,286 - 1,219,286 424,758 1,649,363 2,074,121 - 2,074,121 Option Plans Balance at 1 July 2023 Number forfeited Balance at 30 June 2024 CEO 1,968,704 (1,968,704) - Share price at valuation date $0.85 Volatility 60% Risk free rate 4.27% Expected dividend yield Nil Fair value per right $0.44 Model used Monte Carlo Simulation 80 81 4.3 KEY MANAGEMENT PERSONNEL Compensation of Key Management Personnel (KMP) of the Group The amounts disclosed in the table below are the amounts recognised as an expense during the year relating to KMP: $’000 2024 2023 Short-term employee benefits 1,483 1,498 Post-employment benefits 100 93 Long-term employee benefits 6 2 Share based payments expense 5,497 1,259 Total compensation 7,086 2,852 Section 5 – Other Disclosures This section includes additional financial information that is required by the accounting standards and the Corporations Act 2001. 5.1 BASIS OF PREPARATION Basis of preparation and compliance This financial report: • Comprises the financial statements of Medical Developments International Ltd, being the ultimate parent entity, and its controlled entities as specified in Note 5.4. • Is a general purpose financial report. • Has been prepared in accordance and complies with the requirements of the Corporations Act 2001, Australian Accounting Standards and other authoritative pronouncements of the Australian Accounting Standards Board. • Complies with International Financial Reporting Standards (IFRS) and Interpretations as issued by the International Accounting Standards Board. • Has been prepared on a historical cost basis. • Has revenues, expenses and assets recognised net of GST except where the GST incurred on a purchase of goods and services is not recoverable from the taxation authority, in which case GST is recognised as part of the acquisition of the asset or as part of the expense item to which it relates. The net amount of GST recoverable from or payable to the taxation authority is included as part of receivables or payables in the Consolidated Statement of Financial Position. • Is presented in Australian dollars with all values rounded to the nearest $1,000, unless otherwise stated, in accordance with the ASIC Corporations (Rounding in Financial/Directors’ Reports) Instrument 2016/191 dated 1 April 2016. • Has all intercompany balances, transactions, income and expenses and profit and losses resulting from intra- group transactions eliminated in full. The financial statements of the subsidiaries are prepared for the same reporting period as the Company, using consistent accounting policies. The Group will adopt the new and amended standards and interpretations that are issued, but not yet effective, at the date they become effective. The Groups results and disclosures will not be materially impacted by these standards. Comparatives Where necessary, comparatives have been reclassified and repositioned for consistency with current period disclosure. 5.2 RELATED PARTY DISCLOSURES There were no related party transactions during the 2024 financial year (2023: nil). Balances and transactions between the Company and its subsidiaries which are related parties of the Company have been eliminated on consolidation and are not disclosed in this note. Please also refer to note 4.3 for details of Key Management Personnel compensation. 82 83 5.3 PARENT ENTITY FINANCIAL INFORMATION The above is a summary of the individual financial statements for Medical Developments International Ltd at balance date. Medical Developments International Ltd: • is the ultimate parent of the Group; • is a for-profit company limited by shares; • is incorporated and domiciled in Australia; • has its registered office at 4 Caribbean Drive, Scoresby, Victoria, Australia; and • is listed on the Australian Stock Exchange (ASX) and its shares are publicly traded. $’000 2024 2023 Current assets 23,068 40,646 Non-current assets 33,019 56,220 Total assets 56,087 96,866 Current liabilities 8,671 13,607 Non-current liabilities 3,861 4,451 Total liabilities 12,532 18,058 Net assets 43,555 78,808 Equity Issued capital 105,729 105,729 Reserves 2,852 5,806 Accumulated losses (65,026) (32,727) Total equity 43,555 78,808 Loss of the Parent entity (40,586) (10,896) Total comprehensive loss of the Parent entity (40,586) (10,896) How MVP accounted for information within parent entity financial statements The financial information for the Company has been prepared on the same basis as the consolidated financial statements, except as set out below: • Investments in subsidiaries are accounted for at cost less any impairment in the financial statements of Medical Developments International Ltd. 5.4 CONTROLLED ENTITIES The Group’s subsidiaries at 30 June 2024 are as follows:(1)(2) (1) All entities are wholly owned (2023: wholly owned) (2) Medical Flow Technologies Pty Ltd was a Non-operating Australian subsidiary that was deregistered during the year How MVP accounts for controlled entities Controlled entities are fully consolidated when the Group obtains control and cease to be consolidated when control is transferred out of the Group. The Group controls an entity when it: • is exposed, or has the rights, to variable returns from its involvement with the investee; • and has the ability to affect those returns through its power over the entity, for example has the ability to direct the relevant activities of the entity, which could affect the level of profit the entity makes. United Kingdom Medical Developments UK Limited • Distribution of pharmaceutical drug and respiratory products Ireland Medical Developments MD&P Limited • Holder of European Penthrox® marketing authorisation Netherlands Medical Developments NED B.V. • Distribution of pharmaceutical products United States of America Medical Developments International USA Inc. • Distribution of respiratory products 5.5 AUDITORS REMUNERATION During the year, the following fees were paid or payable for services provided by Medical Developments International Ltd’s external auditors Deloitte Touche Tohmatsu: $ 2024 2023 Fees to Deloitte Touche Tohmatsu Fees for the audit or review of the statutory financial report of the group 235,000 187,500 Fees for taxation compliance services 49,300 38,180 Fees for other services 48,828 - Total fees to Deloitte Touche Tohmatsu 333,128 225,680 84 85 5.6 SEGMENT ASSETS AND SEGMENT LIABILITIES Segment assets Consolidated Entity Disclosure Statement For the year ended 30 June 2024 (1) These reconciling items are managed centrally and not allocated to reportable segments (1) The Group are currently reviewing the tax residency of Medical Developments NED B.V. to determine if it meets the criteria of an Australian tax resident. This will include making a submission to the Australian Taxation Office, so a formal assessment of tax residency can be achieved. $’000 2024 2023 Pain Management 39,898 58,891 Respiratory 8,262 7,947 Total Segment Assets 48,160 66,838 Reconciliation to total assets(1): Cash and cash equivalents 9,735 24,661 Deferred tax assets - 8,112 Other 1,266 1,702 TOTAL ASSETS 59,161 101,313 Segment liabilities $’000 2024 2023 Pain Management 5,994 11,997 Respiratory 2,260 2,579 Total Segment Liabilities 8,254 14,576 Reconciliation to total liabilities(1): Employee benefits provisions 948 1,070 Deferred tax liabilities 19 - Lease liabilities 2,286 2,560 Unearned income 1,920 1,792 TOTAL LIABILITIES 13,427 19,998 5.7 SUBSEQUENT EVENTS On 26 July 2024 the Group announced a fully underwritten capital raise of $10 million comprising an institutional placement and non-renounceable entitlement offer to accelerate growth and improve balance sheet strength. The institutional component of the placement was completed on 30 July 2024 with gross proceeds of $6.9m being received. The entitlement offer closed on 22 August 2024, with gross proceeds of $3.1 million expected to be received on 27 August 2024. Other than included above, there has not been any matter or circumstance that has arisen that has significantly affected, or may significantly affect the operations of the Group, the results of those operations, or the state of affairs of the Group in future years. Entity name(1) Entity type Place of incorporation Share capital held Tax residency Medical Developments International Limited Body Corporate Australia N/A Australia Medical Developments UK Limited Body Corporate United Kingdom 100% United Kingdom Medical Developments MD&P Limited Body Corporate Ireland 100% Ireland Medical Developments NED B.V. Body Corporate Netherlands 100% Netherlands(1) Medical Developments International USA Inc. Body Corporate United States 100% United States 86 87 Number of holders of equity securities Ordinary share capital 112,658,324 fully paid ordinary shares held by 9,842 individual shareholders. All issued ordinary shares carry one vote per share. Distribution of holders of equity securities Fully paid ordinary shares as at 28 August 2024 1-1000 5,261 1,001-5,000 2,836 5,001-10,000 782 10,001-100,000 886 100,001 and over 77 9,842 Holding less than a marketable parcel 0 Substantial Shareholders Number % MR DAVID JOHN WILLIAMS 13.087,497 11.62% Regal Funds Management Pty (and associated entities) (reported at 5 August 2024) 10,617,984 10.16% Twenty largest holders of equity securities Number % J P MORGAN NOMINEES AUSTRALIA PTY LIMITED 10,683,815 9.48 CITICORP NOMINEES PTY LIMITED 7,576,013 6.72 HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED 6,500,532 5.77 LAWN VIEWS PTY LTD 5,904,120 5.24 MOGGS CREEK PTY LTD 5,278,615 4.69 UBS NOMINEES PTY LTD 4,920,177 4.37 NETWEALTH INVESTMENTS LIMITED 3,650,550 3.24 PAYNE MEDIA PTY LTD 2,937,127 2.61 MIRRABOOKA INVESTMENTS LIMITED 2,592,084 2.30 DR RUSSELL KAY HANCOCK 2,120,000 1.88 HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED - A/C 2 1,367,424 1.21 BNP PARIBAS NOMINEES PTY LTD 1,364,260 1.21 NAYLOR-STEWART INVESTMENTS PTY LTD 1,045,113 0.93 KIDDER PEABODY PTY LTD 1,042,945 0.93 MERRILL LYNCH (AUSTRALIA) NOMINEES PTY LIMITED 867,848 0.77 MR DAVID WILLIAMS 861,817 0.76 NEWECONOMY COM AU NOMINEES PTY LIMITED <900 ACCOUNT> 861,039 0.76 MR ALISTAIR DAVID STRONG 750,000 0.67 NATIONAL NOMINEES LIMITED 748,009 0.66 BNP PARIBAS NOMINEES PTY LTD 733,300 0.65 Additional Stock Exchange Information Directors’ Declaration The directors declare that: a) in the directors’ opinion, there are reasonable grounds to believe that the company will be able to pay its debts as and when they become due and payable; b) in the directors’ opinion, the attached financial statements and notes thereto are in accordance with the Corporations Act 2001, including compliance with accounting standards and giving a true and fair view of the financial position and performance of the Group; c) the attached financial statements are in compliance with International Financial Reporting Standards, as stated in note 5.1 of the financial statements; and d) the directors have been given the declarations required by s.295A of the Corporations Act 2001. e) In the directors’ opinion the attached Consolidated Entity Disclosure Statement is true and correct Signed in accordance with a resolution of the directors made pursuant to s.295(5) of the Corporations Act 2001. On behalf of the Directors Gordon Naylor Company Chair Dated 26 August 2024 Medical Developments International Limited is a listed public company, incorporated and domiciled in Australia. Company Secretary Ms. Tara Eaton Registered office and principal place of business 4 Caribbean Drive Scoresby, VIC 3179 Tel: (03) 9547 1888 Share registry Computershare Investor Services Pty Ltd 452 Johnston Street Abbotsford, VIC 3067 Tel: 1300 850 505

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