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Annual Report 2015

Plain-text annual report

Annual Report 2015 Delivering emergency medical solutions dedicated to improving patient outcomes Full-Year Report 2015 Financial Year Ended 30 June 2015 (Previous corresponding period: financial year ended 30 June 2014) Contents Chairman’s and CEO’s report Summary of key achievements Review of operations Product portfolio Pharmaceutical Medical devices Oxygen & other medical equipment Veterinary Board of directors Full-year report Financials Additonal stock exchange information Corporate directory 2 5 6 9 10 11 12 13 14 15 16 65 66 1 Annual Financial Report 2015textChairman’s and CEO’s Report A Milestone Year For MVP JOHN SHARMAN CEO DAVID WILLIAMS CHAIRMAN Medical Developments International Limited. (“MVP”) (ASX: MVP) delivered a Net Profit after Tax of $1.529 million for the year ended 30 June 2015. Sales grew 24% to $11.608m, whilst Earnings Before Interest and Tax grew 191% to $2.251 million. In May it was announced that the Medicine and Healthcare products Regulatory Agency (“MHRA”) had issued the Final Assessment Report with the support of France, Belgium and Ireland authorities noting all outstanding issues pursuant to the Decentralised Procedure have been successfully resolved and Penthrox® is approvable. We are currently working through the National Phase which is the final step in the ultimate approval of Penthrox® for sale in these markets. We estimate there are 50 million Accident & Emergency hospital attendances each year across these countries. Elsewhere in the world, our Regulatory Dossier, used in the United Kingdom, France, Belgium and Ireland has already been submitted or is in the process of being submitted to regulatory agencies in Russia, Saudi Arabia, Israel, Singapore, Mexico, Hong Kong, Malaysia, Taiwan and Iran. We expect regulatory approvals to sell Penthrox® in these markets to be granted over the course of the next 12–18 months. The company is now also focusing on getting Penthrox® approved for sale in the USA. Our initial advice is that our Regulatory Dossier can be used as the basis for our submission to the FDA. We are in the process of appointing a US regulatory consultant to help us through this process. Overall sales of asthma devices across our markets in Australia, New Zealand, Europe and North America increased by 36% in FY15. A key feature of this growth was in Europe, where focused sales efforts drove growth in the region by 172%. North American asthma device sales grew 593%, aided by the appointment of a Canadian based General Manager of Sales. We expect further sales shortly into this largely untapped market as a result of further FDA 510(k) submissions and approvals. NET PROFIT AFTER TAX TOTAL SALES EARNINGS BEFORE INTEREST AND TAX NET PROFIT AFTER TAX $1.529m 24% UP ON PRIOR PERIOD 191% UP ON PRIOR PERIOD 75% UP ON PRIOR PERIOD BANK DEBT* $2.46m CASH FLOWS FROM OPERATING ACTIVITIES 159% UP ON PRIOR PERIOD * net bank debt of nil when combined with closing cash balances FY15 Group Cash Flow 12,135 (9,245) 14,000 12,000 10,000 8,000 6,000 4,000 2,000 1,659 Cash movement ($,000) (2,534) 111 (65) 5 423 (555) (46) 22 (957) 954 0 R eceipts fro m custo m ers P ay m ents to suppliers O pening cash balance and e m ployees R eceipts fro m govern m ent grants Inco m e tax received Interest paid R epay m ent of borro wings Hire purchase finance costs P ay m ents for other P ay m ents for plant Interest received intangible assets and equip m ent Other Closing cash balance Global Penthrox ® Strategy Canada European Union Moldova Kazakhstan USA Mexico Ireland Israel Iraq UK Iran Japan Malaysia UAE Qatar Singapore South Africa Australia New Zealand Key Current key Penthrox® markets Pending Registrations / emerging markets Future Key Achievements for FY15 Penthrox® Respiratory Medical Devices Other Strong sales growth for Penthrox® in Australia. First sales of Penthrox® in South Africa. Approvable finding for Penthrox® in Europe. Regulatory submissions made in multiple countries. Appointed Galen Ltd as distribution partner in UK & Ireland and received upfront payment. Strong sales growth in Dental market. Strong sales growth to Australian General Practitioners & Hospitals markets. Strong sales growth in the Middle East. Progress in product development. Strong rebound in Australian Respiratory Device sales. Established North American office. Established additional distribution channels in Europe. Appointed PSUK as the exclusive distributor of MVP’s range of respiratory devices for the UK. Significant sales growth in New Zealand. Strong sales growth from international markets including Europe and Canada. New product lines approved for sale in Australia, Asia, Europe and North America. Successfully completed construction of the commercial scale plant for the new methoxyflurane manufacturing process. Ongoing improvement in manufacturing costs and efficiency. 159% improvement in cash generated from operating activities. $2.5 million reduction in bank debt position (net bank debt of nil when combined with cash balances). Claimed R&D Tax Incentive concession of $282k. Claimed other export and marketing related grants totalling $111k. Continued investment in new product development. Continued investment in clinical development programs and trials. Review of Operations Pharmaceuticals All segments of our Penthrox® business performed strongly and sales of Penthrox® grew 32% compared to FY14. Sales to our Ambulance business grew by 22% and sales to Hospitals and General Practitioners grew 32%. Sales for our Dental business grew 67% which is the result of our business partner expanding our presence in this market. Internationally we made our first sales to South Africa in FY15. We expect South Africa to be a significant market for Penthrox®. Sales in the Middle East grew 118%. Clinical Developments MVP continues its program of developing applications for Penthrox®. Additional clinical trials are planned which may open up new areas of use for Penthrox®. During the year we have directly and indirectly progressed the following clinical studies: • A psychomotor function study undertaken at Royal Adelaide Hospital aimed at demonstrating that the use of Penthrox® would not impair a patient’s ability to drive or operate machinery is in its final stages with patient recruitment completed in June 2015. The results indicate Penthrox® induces an acute but short-lasting impairment of psychomotor and cognitive performance, which returns to normal within 30 minutes after inhalation. This is a significant result for Penthrox® and means that patients do not require longer term monitoring after the administration of Penthrox®, and patients can be safely returned to tasks that require high psychomotor skills such as driving 30 minutes after cessation of Penthrox®, which is a very significant advantage over all of its narcotic competitors. • An active comparative trial in Singapore, which compares the benefits of intramuscular Tramadol v Penthrox® in an Ambulance setting. This trial is progressing well with recruitment having been completed. Interim results are very positive for Penthrox® and we expect this trial will be completed towards the end of 2015. • We are developing three additional clinical trials in 2015 which will support our marketing efforts in Europe and elsewhere. Commercialisation SOUTH AFRICA After receiving approval to sell Penthrox® in South Africa in June 2014, we made our first sales to South Africa in FY15. We expect South Africa will be a significant market for Penthrox® and should grow significantly in FY16. EUROPE MVP is finalising contracts with a significant pharmaceutical company having expertise in pain management products to distribute Penthrox®. UK AND IRELAND MVP entered into an exclusive Distribution, License and Supply Agreement with Galen Limited to supply Penthrox® in the United Kingdom and Ireland. Sales to Galen are expected in the first half of FY16. USA MVP has commenced the process of reviewing the necessary steps to get Penthrox® approved for sale in the USA including the appointment of professional advisors. The USA approval will become a key priority in FY16 and beyond. RUSSIA We have been working on our Russian Registration Dossier to have Penthrox® approved for sale In Russia for more than two years. The Russian Registration Dossier has been 6 Medical Developments International Limitedreviewed by experts and our application lodged with the Ministry of Health for Russia. EASTERN EUROPE AND MIDDLE EAST We have achieved very significant sales success in the Middle East. Our business grew by 118% and is showing signs of further growth potential in FY16. In Eastern Europe our business performed below expectations with sales falling 17%. This is mainly due to the political unrest in the region and we expect this business to recover in FY16. AUSTRALIA Domestically, sales to Ambulance increased 22% during the year due to growth across all mainland states and territories. of doctors and pharmacies in the UK with medical devices. We have also made progress on mainland Europe with sales growing 93%. We expect further very significant sales and profitability growth in our European/UK Respiratory Device business during FY16. NEW ZEALAND Our New Zealand business grew 17% in FY15. ASIA We have increased our presence and marketing efforts throughout Asia and sales into this region grew 8% year on year. We expect further growth in FY16. s n o i t a r e p O f o w e v e R i Medical Devices: Respiratory Overall Respiratory sales have increased 42% in FY15. AUSTRALIA Our Australian respiratory business has rebounded well from a difficult FY14 and with sales increasing 13%. Much of FY15 growth can be attributed to our spacer range now being stocked in Australia’s two largest retail pharmacy chains. NORTH AMERICA Our North American Respiratory business has grown significantly in FY15, increasing by 593% as a result of our distributors success in winning more tenders and increasing their range of MVP respiratory products sold in the market. Our “anti-static” Compact Space Chamber Plus products are expected to be approved by the FDA shortly and having a full range of our respiratory products approved and available for sale is expected to deliver further significant growth in FY16. Our initial assessment of the USA market is that there are approximately 20 million space chamber devices sold each year. Our products are amongst the world’s best and our ambition is to win significant market share over the coming years. EUROPE Our business in Europe (including the UK) was profitable for the first time since established. Respiratory sales grew 172% in FY15. During FY15, MVP entered into an exclusive agreement with PSUK to supply its range of respiratory devices in the UK. The agreement includes minimum quantities for 3 years that will drive ongoing sales growth of respiratory devices in the UK. PSUK supply the majority Vet Our Vet business declined 11% in FY15. However we achieved a significant improvement in H2FY15 because we opened new markets in China and South East Asia. Our increased sales efforts and continued fall in the Australian dollar is expected to further help our export business in FY16. Research and Development During FY15 we completed the final stage of constructing our commercial scale plant for the new methoxyflurane manufacturing process. Three validation batches using the new process were completed under production conditions. This initiative will revolutionise our manufacturing process and transform the cost base for Penthrox®. In addition to valuable intellectual property, this project will create ongoing options for innovation and growth which previously did not exist. Operating Expenses During the year, the Company invested heavily in our regulatory, product development, sales, marketing and research and development teams. The investment in clinical studies, research and development and product development has been capitalised to intangible assets where appropriate. The Company will invest in additional studies in FY16 to support both the European registration and the company plans to pursue opportunities in North America. We received a $0.282 million R&D tax incentive refund during the year and a further $0.133 million is expected in the coming months in relation to FY15. 7 Annual Financial Report 2015 Dividend No dividends are declared. Outlook Our ambition is to make Penthrox® a main stream analgesic of choice around the world and our Respiratory Devices leaders in the field. Penthrox® is a category leading drug in Australia and we expect it can dominate many of the trauma and minor surgical procedure markets around the world. With the completion of our Regulatory Dossier, a number of licensing deals successfully concluded and with the successful completion of our CSIRO manufacturing project, we have the base to make MVP a global pharmaceutical company. The growth experienced in asthma device sales in FY15 will be built on in FY16 as a result of growth within existing customer accounts, new product registrations and new overseas market opportunities in the USA and Europe. FY15 has been an improved year in terms of sales and profit. However FY16 and beyond should see the flow through results of new global registrations, licensing deals and recent staff hires, combining to deliver further sales and profit growth. We would like to thank our staff and our trading partners for their efforts and support. Further Information: MR JOHN SHARMAN CHIEF EXECUTIVE OFFICER MR DAVID WILLIAMS CHAIRMAN +61 3 9547 1888 +61 414 383 593 8 Medical Developments International LimitedProduct Portfolio Pharmaceutical ANALGESIA Penthrox® Medical ASTHMA Space Chamber Plus® Compact Space Chamber Plus® Space Chamber Plus® autoclavable spacer Breath-Alert® peak flow meter MyMVP™ Portable Nebuliser MyMVP™ Pulse Oximeter FACE MASKS EZ-fit silicone and disposable face masks OXYGEN OXI-Port® oxygen therapy device OXI-Sok oxygen therapy device OXI-Pro oxygen resuscitation device OXI-Life oxygen resuscitation device OXI-Saver™ closed circuit oxygen resuscitation device OXI-Dive closed circuit oxygen resuscitation device OXI-Vac™ suction system REGULATORS KDK™ regulator/flow meter with oxygen flush ABSORBERS KAB™ carbon dioxide absorber Veterinary ANAESTHESIA MK5 closed circuit anaesthetic machine LANA closed circuit anaesthetic machine Mini-KOM™ anaesthetic machine Breath-Alert® breathing monitor 9 Annual Financial Report 2015 Pharmaceutical MVP is a world leader in the management of acute and procedural pain. Building our Business MVP manufactures its world leading inhaler analgesic from its premises in Springvale, Victoria, Australia. MVP is the sole manufacturer of the active molecule worldwide and continues to develop new markets and applications for the iconic brand Penthrox®. Penthrox® continues to be used as a ‘first line’ product for the treatment of pain in trauma by all Ambulance Services in Australia. MVP continued the promotional focus into the Australian Ambulance services ensuring that the strong positioning of Penthrox® is maintained. Moving forward, the strategy is to continue to broaden the range of customers (hospitals, general practice, dental and cosmetic) and countries that can be served by Penthrox®. PRODUCT SUITE MVP is continuing to develop additional formulations of Penthrox® to provide improved convenience, utility and value for its customers. 10 Medical Developments International LimitedMedical Devices PRODUCT DEVELOPMENT MVP’s Space Chamber is well known in the market place as the ‘Rolls Royce’ brand and it offers the greatest opportunity for future growth in the Asthma devices market. To assist in future growth MVP has developed new and improved Space Chambers to assist with differentiation and local and international penetration. Building our product range MVP’s focus in FY16 will be to add to our established product range, to build on the solid foundation that has been established with our current partnerships in Australia and overseas. At the same time MVP will develop new collaborations for future growth. Core to the growth is the development of new and improved models of: • Asthma/COPD Space Chambers • Peak Flow Meters • Portable Nebulisers • Pulse Oximeter • Face Masks • Tourniquets • Emergency Medicine consumable equipment ASTHMA DEVICES MVP’s Asthma devices business has been strong for many years and continues to provide solid sales and profit. The success of this business over recent years has been due to four factors: • The strength of our Asthma devices business with our partner in New Zealand • The strength of the Allersearch brand in Australian Hospitals and Pharmacies and our distribution partner • The growth of the OAPL sales in Hospitals and Pharmacies within Australia • Growing sales of our range of Asthma products through established international partners and new customers 11 Annual Financial Report 2015Oxygen & Other Medical Equipment Safe, precision engineering and custom design kits and accessories MVP manufactures a range of oxygen therapy and resuscitation equipment, providing healthcare professionals and trained personnel with the ability to administer oxygen to patients in an emergency situation. These devices range from basic through to advanced systems of delivering oxygen therapy or resuscitation. PRODUCT SUITE • OXI-Port® oxygen therapy device • OXI-Sok oxygen therapy device • OXI-Pro oxygen resuscitation device • OXI-Life oxygen resuscitation device • OXI-Saver™ closed circuit oxygen resuscitation device • OXI-Dive closed circuit oxygen resuscitation device • OXI-Vac™ suction system These products are all custom assembled and tested at MVP’s facilities in Melbourne, Australia. THE MARKET MVP’s oxygen equipment is purchased and used by: • Ambulance services • • Fire brigades Life saving clubs • Military 12 Medical Developments International LimitedVeterinary MVP re-invigorates its Veterinary product range PRODUCTS • Anaesthetic machines • Vaporisers • Breathing monitors THE MARKET MVP offers a range of open and closed circuit anaesthetic machines to the veterinary market, which are popularly known as Komesaroff anaesthetic machines. MVP has developed a unique market position regarding the design, manufacture and supply of closed circuit anaesthetic machines to this particular niche market in Europe. Whilst the majority of MVP’s veterinary products continue to be sold in Europe through our distributor, Kruuse (one of Europe’s largest veterinary distribution companies), the launch of a new machine, and with a new catalogue locally veterinary sales continue to grow. NEW PRODUCT DEVELOPMENT MVP’s Breath-Alert® breathing monitor (Mark IV) continued to sell well on new but simple selling features such as size (smaller unit), ease of use and battery longevity. Through new products a specifically tailored catalogue and promotion via our Australian distributor will assist future sales growth. 13 Annual Financial Report 2015Board of Directors Mr David Williams Dr Harry Oxer ASM Mr Leon Hoare Non-Executive Chairman Mr Williams is the Managing Director of Kidder Williams Ltd, with over 30 years experience in the investment banking sector. He is also Chairman of PolyNovo Limited. Mr Williams is Chairman of the Remuneration and Nominations Committee. Non-Executive Director Dr Oxer is a Medical Consultant to MVP and St John Ambulance in Western Australia. Dr Oxer was a long-time member of the State Executive for St John Ambulance (WA) until his retirement in rotation in 2012, and was the previous Medical Director for 26 years. He has taught, lectured and published extensively over the years, both nationally and internationally. Dr Oxer is also a past Chairman of the Australian Resuscitation Council and has a major interest in resuscitation, oxygen therapy and pain relief. Non-Executive Director Mr Hoare is the Managing Director of Smith & Nephew in Australia & New Zealand (covering all Divisions), which is one of the largest global subsidiaries (outside the USA). In his 24 years with Smith & Nephew, he has held roles in Marketing, Divisional and General Management, and was most recently Asia Pacific President of the Advanced Wound Management (AWM) Division, before advancing to the Managing Director role in 2014. He has also been a member of the Global Executive Management for the AWM Division of Smith & Nephew whilst leading Asia Pacific. External to Smith & Nephew, Mr Hoare previously held board roles (including as Vice-Chair) with Australia’s peak medical device body, Medical Technology Association of Australia (MTAA). Mr Max Johnston Non-Executive Director Mr Johnston is a non-executive director of Enero Group Limited, Polynovo Limited and Chairman of Probiotec Limited. For 11 years he was President and Chief Executive Officer of Johnson & Johnson Pacific and an Executive Director of Johnson & Johnson. Mr Johnson has also held several prominent industry roles as a past President of ACCORD Australasia Limited, a former Vice Chairman of the Australian Food and Grocery Council and a former member of the board of ASMI. Mr Johnson has had extensive overseas experience during his career in leading businesses in both Western and Central- Eastern Europe, Africa as well as Asia- Pacific. Mr Johnston is also a member of the MVP Audit & Risk Committee. Mr Philip Powell Non-Executive Director Mr Powell, a Chartered Accountant, has an extensive finance background and commenced working in investment banking in 1996 at Hambros Corporate Finance following ten years industry experience in senior finance roles with ASX listed public company OAMPS Limited. Prior to these roles, he worked for ten years within the Assurance Division at Arthur Andersen & Co. From January 2006 to July 2013 he was an Executive Director at Corporate Finance Advisory firm Kidder Williams. Philip is also a Non-executive Director of PolyNovo Limited (ASX:PNV). Philip is Chairman of MVP’s Audit and Risk Committee. Mr Allan McCallum Non-Executive Director Mr McCallum has over 15 years public companies experience including an ASX 50 company and has served on numerous committees including: Audit, Remuneration & Nomination, and as an Independent Director on Related Parties (Governance) Committees. Mr McCallum is a member of the Remuneration and Nominations Committee. He is also Chairman of Tassal Group Ltd. Full-Year Report 2015 Financial Year Ended 30 June 2015 (Previous corresponding period: financial year ended 30 June 2014) 15 Annual Financial Report 2015textAnnual Financial Report for the Financial Year Ended 30 June 2015 Contents Corporate Governance Statement Directors’ Report Independence Declaration to the Directors of Medical Developments International Limited Independent Auditor’s Report to the Members of Medical Developments International Limited Directors’ Declaration Consolidated Statement of Profit or Loss and Other Comprehensive Income for the Financial Year ended 30 June 2015 Consolidated Statement of Financial Position as at 30 June 2015 Consolidated Statement of Changes in Equity for the Financial Year Ended 30 June 2015 Consolidated Statement of Cash Flows for the Financial Year Ended 30 June 2015 Notes to the Financial Statements for the Financial Year Ended 30 June 2015 17 22 32 33 35 36 37 38 39 40 16 Medical Developments International Limited Corporate Governance Statement The Board of Directors is ultimately responsible for all matters relating to the running of the company and is committed to implementing the highest standards of corporate governance. The Board’s role is to govern the organisation rather than manage it. It is the purpose of senior management to manage the organisation in accordance with the direction of the Board. The Board is responsible for: • setting the goals of the company, including short-term, medium-term and long-term objectives; • providing the overall strategic direction of the company; • • • • • • • appointing and approving the terms and conditions of the Chief Executive Officer and reviewing their ongoing performance; endorsing the terms and conditions of senior executives through the Remuneration Committee; establishing and determining the powers and functions of the committees of the board, including the Audit & Risk Committee and the Remuneration Committee; reviewing the Board’s structure and performance from time to time and making decisions on new appointments to the Board; approving the annual budget and long-term budgets; approving all mergers and acquisitions, and property acquisitions and disposals; the issue of any shares, options, equity instruments or other securities in MVP or its subsidiaries; • determining the ethos of the company and ensuring that the group adheres to appropriate standards and values and applicable laws; and • representing the interests of shareholders. To assist in the execution of these responsibilities, the Board has two Board Committees being: • an Audit and Risk Committee (Mr P Powell (Chairman who joined on 17 December 2014) and Mr M Johnston). Mr Johnston was Chairman of the Audit and Risk Committee from July to December 2014 during which time David Williams was also a member up until the appointment of Mr P Powell; and • a Remuneration and Nominations Committee (Mr D Williams and Mr A McCallum). All other functions of the Board will be dealt with by the Board as a whole. However, from time to time, the Board may determine to establish specific purpose sub- committees to deal with specific issues. Share trading The Board has adopted a share trading policy for Directors and officers of the company. The Policy regulates dealings 17 Annual Financial Report 2015by Medical Developments International Limited (“MVP”) directors, officers and employees in MVP securities. The standards and conduct adopted by the Board reflect, where applicable, the standards for Corporate Governance as provided in the ASX Corporate Governance Principles established by the ASX Corporate Governance Council. The following sections summarise MVP’s compliance with these principles. Unless explicitly stated otherwise, the Directors believe MVP complies with the Corporate Governance Council’s recommendations. Principle 1: Lay solid foundations for management and oversight Duties of the Board and of management are clearly segregated and stated in the company’s Corporate Governance Manual. The Board’s role and responsibilities are also summarised above. Senior executives are evaluated by the remuneration committee annually, based on the company’s performance and specific key performance indicators set for the respective senior executive. All senior executive appointments involve a formal written agreement that is reviewed and signed off on by both the CEO and relevant Executive. The Board undertakes formal interviews and reference checks to assess the appropriateness of all candidates. Information relevant to the decision on whether or not to elect or re-elect a director is summarised within the Annual General Meeting Notice of Meeting which is sent to all security holders and also released to the ASX and published on the company website. Individual agreements with each of the directors do not exist, however the duties and obligations of Directors are specifically outlined in the Corporate Governance Manual and the remuneration of Directors is addressed at least annually by the Remuneration and Nomination Committee. The Company Secretary reports to the Chairman on all Board functioning and Corporate Governance related matters. The Company Secretary attends Board meetings and has input into materials distributed as part of these meetings. Furthermore, Corporate Governance related matters are addressed as a specific agenda at Board meetings. RECOMMENDATION 1.5-1.6 Companies should establish a policy concerning diversity and disclose the policy or a summary of that policy. The policy should include requirements for the board to establish measurable objectives for achieving gender diversity and for the board to assess annually both the objectives and progress in achieving them. The Company has established and disclosed (on its website) its Diversity Policy in accordance with the recommendation. Companies should disclose in each annual report the measurable objectives for achieving gender diversity set by the board in accordance with the Diversity Policy and progress towards achieving them. The Board believes in the value of diversity but does not believe that given the size of the company and the resources available to it, that formalising measurable objectives for achieving gender diversity is appropriate. As the company grows, the Board will continue to monitor the Diversity Policy including formalising measurable objectives for achieving gender diversity. While there is currently no gender diversity on the Board, the Board is made up of individuals from various professions, cultures, and backgrounds. The Company’s workforce is comprised of three distinct employee groups: 1. Employees engaged in senior management roles which constitutes 28% of the workforce; 2. Employees engaged in middle management roles which constitutes 10% of the workforce; and 3. Employees engaged in tier three level activities such as production, sales, and administration type roles which constitutes 62% of the workforce. Principle 2: Structure the Board to add value The directors believe that the composition, size and commitment of the Board will allow it to effectively discharge its responsibilities and duties. To this end, currently five of the six Board members are independent under the definition of the Council. Furthermore, while the Chairman, Mr Williams is not considered independent under the Council definition and thus recommendation 2.2 is not followed, the Board does not believe that Mr Williams being a substantial shareholder has had or will have any adverse impact on the conduct of MVP’s affairs or the representation of the interests of other shareholders. Furthermore, the roles of Chairman and CEO are not exercised by the same individual. A formal Board skills matrix is not presented, however the Annual Report contains key details regarding each Boards members qualifications, career experience and other appointments. The company has no formal process for evaluating the performance of its Board, committees and individual 18 Medical Developments International LimitedDirectors. As such, recommendation 1.6 is not followed. Instead the Board uses regular informal assessments to evaluate its performance. To further ensure Directors can fulfil their obligations, the Board has adopted a policy, contained in the company’s corporate governance manual that allows directors to take independent professional advice, at the expense of the company. The information required by recommendation 2.2 regarding the skills, experience and expertise of the individual Directors is included in the Director’s Report and is not repeated here. The Board has established a two member Remuneration and Nominations committee as suggested by recommendation 2.1. Whilst this is less than the three required by recommendation 2.1 & 8.1, the Board believes a three member committee is impractical given the overall size of the Board. A formal charter does not exist, however all Board members are consulted on the appropriateness of new Board candidates to ensure a diverse balance of skills, knowledge and experience is achieved to enable the Board to discharge its duties and responsibilities effectively. Principle 3: Promote ethical and responsible decision-making The Board actively promotes ethical and responsible decision-making. Companies should establish a code of conduct and disclose the code or a summary of the code as to the practices necessary to maintain confidence in the company’s integrity; the practices necessary to take into account their legal obligations and the reasonable expectations of their stakeholders; and the responsibility and accountability of individuals for reporting and investigating reports of unethical practices. The Company has established and disclosed (in its Induction Handbook) its Code of Conduct in accordance with this recommendation. The Code of Conduct applies to Directors, managers and employees of the Company. The Code of Conduct is reviewed as necessary to ensure it reflects the high ethical standards of conduct necessary to maintain confidence in the Company’s integrity. The Board has implemented and disclosed a share trading policy covering Directors, senior executives and employees. The Directors are aware of their responsibility to communicate any share trading to the company, and the company notifies the ASX of any share transactions within the allowed five business days. The Board has adopted a policy for trading in Medical Developments International securities by Directors and employees. The purpose of this policy is to define the circumstances in which Directors, employees and any associates are permitted to deal in securities. The updated policy addresses each of the ASX requirements including provisions relating to the prohibition of trading by directors and senior management in the Company’s securities during defined periods. Principle 4: Safeguard integrity in financial reporting The Board has ensured there is a structure in place to independently verify and safeguard the integrity of the company’s financial reporting. The Board has established an Audit and Risk Committee comprised of two non-executive Directors. While this is less than the three required by recommendation 4.2 & 7.1, the Board believes a three member committee is impractical given the overall size of the Board and that the current composition of the committee allows it to discharge its mandate effectively. The Committee’s Charter is contained within the company’s Corporate Governance manual and also included on the company’s website. Principle 5: Make timely and balanced disclosures The company has put in place mechanisms designed to ensure compliance with the ASX Listing rules and Corporations Act requirements regarding continuous disclosure. The Corporate Governance Manual details the company policy and all management staff are made aware of it. The company is committed to ensuring all market participants have equal access to information and so updates and presentations continue to be provided to the ASX and posted on the company website. If a presentation contains information that is not public and may have a material effect on the share price, the material is sent to the ASX prior to the presentation being made. Principle 6: Respect the rights of shareholders A formal documented investor relations program does not exist. However the CEO holds regular investor roadshows and information presented at such roadshows is also released to the market. Furthermore, both the Chairman and t n e m e t a t S e c n a n r e v o G e t a r o p r o C 19 Annual Financial Report 2015 CEO make themselves available to take calls directly from investors and their contact details are provided within each ASX announcement. The Board of Directors has adopted a policy to ensure that shareholders are informed of all major developments affecting MVP in a timely manner. In accordance with this policy, information is communicated in a variety of ways including: • A half-yearly report containing summarised financial information and a review of operations • An annual report with detailed financial information and review of the operations of the company and future outlook • Updates on operations and developments lodged with the ASX • A comprehensive website carrying the latest news and containing an investor relations section which includes corporate governance information and an archive of periodic reports and ASX releases. MVP has functionality within its existing website to collect investor email addresses to then have those included on a key company announcement email distribution list. The website also contains a detailed ‘Contact Us’ page which enables investors to contact MVP via a number of different mediums. Security holders also have the option to receive and communicate with MVP electronically via the security registry (currently Computershare). The external auditor is required to attend the Annual General Meeting and is available to answer questions. Furthermore, the company encourages shareholders to attend the Annual General Meeting and ask questions. Principle 7: Recognise and manage risk The management of risk is considered by the Audit and Risk Committee. The Board determines whether management has developed and implemented a sound system of risk management and internal control and this review has again taken place in FY15. The Chief Executive Officer and Group Financial Controller state to the Board in writing that there is a sound system of risk management and internal compliance and control within the company and that this system operates effectively in ensuring that financial reporting risks are managed such that the declaration required by s.295A of the Corporations Act can be provided. The Company does not have its own internal audit function as it is considered impractical for a company the size of MVP to have one. Instead risk management and internal control matters are addressed as part of the Audit and Risk Committee Charter. Principle 8: Remunerate fairly and responsibly The Board has established a Remuneration committee to ensure Directors, executives and staff are remunerated appropriately. The committee reviews remuneration packages at least annually in the light of market conditions, performance of the individual and the performance of the company. The Remuneration report contained within the Director’s Report includes considerable detail on the current remuneration of directors and executives including how performance conditions for performance related payments are chosen and assessed. Diversity The Company has established a policy concerning diversity which is available on its website. The policy outlines the Company’s commitment to diversity, which is underpinned by the following key principles: • Attracting, engaging and retaining a talented and diverse workforce; • Recognising the need for workplace flexibility to support the role employees at all levels have outside of the workplace; • Improving the quality of decision-making, creativity, productivity and teamwork; • Enhancing service delivery through a workforce that respects and reflects the diversity of our customers; • Building and maintaining a safe work environment by taking action against inappropriate behaviour (including discrimination, harassment, bullying, victimisation and vilification); and • Facilitating equal employment opportunities by considering a broad and diverse talent pool and making decisions based on merit, ability, performance and potential. The Company’s Diversity Policy outlines the following key areas of focus: • Conducting recruitment in a structured manner consistent with Equal Employment Opportunity principles and the objectives of this policy; 20 Medical Developments International Limited• Undertaking structured talent management and succession planning reviews; • Undertaking targeted diversity, culture and engagement initiatives; • Establishing and reviewing appropriate and aligned human resource policies and procedures; and • Consistent messaging in internal communication. Annual reporting on the Company’s Diversity Policy and proportion of women There is one woman currently in a senior management role. Overall women represent 48% of the workforce of the Company. The Company has implemented a strategy designed to increase the representation of women at the senior management level. To aid in the attraction and retention of female employees, the Company has carer’s leave in place as well as making part-time work available. The Company always seeks to accommodate individual circumstances to ensure all employees can manage their work-life balance. t n e m e t a t S e c n a n r e v o G e t a r o p r o C 21 Annual Financial Report 2015 Directors’ Report The directors of Medical Developments International Limited (“MVP”) herewith submit the annual financial report of the company for the financial year ended 30 June 2015. In order to comply with the provisions of the Corporations Act 2001, the directors report as follows: Dr H F Oxer, AM, ASM, KStJ MA (Hons), MB.BChir (Cantab), MRCS.LRCP, DA, FFARCS, FRCA, FFARACS, FANZCA, FACAP, DipDHM Non-Executive Director (since 28 December 2006) Dr Oxer is a Medical Consultant to MVP and St John Ambulance in Western Australia. Dr Oxer was a long-time member of the State Executive for St John Ambulance (WA) until his retirement in rotation in 2012, and was the previous Medical Director for 26 years. He has taught, lectured and published extensively over the years, both nationally and internationally. Dr Oxer is also a past Chairman of the Australian Resuscitation Council and has a major interest in resuscitation, oxygen therapy and pain relief. Information about the Directors The names and particulars of the directors of the company during or since the end of the financial year are: Mr D J Williams, B.Ec (Hons), M.Ec, FAICD Non-Executive Chairman (since 16 September 2003) Managing Director of Kidder Williams Ltd, with over 30 years experience in the investment banking sector. He is also Chairman of PolyNovo Ltd. Mr Williams is Chairman of the Remuneration and Nominations Committee. Mr A D McCallum, Dip.Ag Science, FAICD Non-Executive Director (since 27 October 2003) Mr McCallum has over 15 years public companies experience including an ASX 50 company and has served on numerous committees including: Audit, Remuneration & Nomination, and as an Independent Director on Related Parties (Governance) Committees. Mr McCallum is a member of the Remuneration and Nominations Committee. He is also Chairman of Tassal Group Ltd. Mr R M Johnston Non-Executive Director (since 5 November 2012) Mr Johnston is a non-executive director of Enero Group Limited, Polynovo Limited and Chairman of Probiotec Limited. For 11 years he was President and Chief Executive Officer of Johnson & Johnson Pacific and an Executive Director of Johnson & Johnson. Mr Johnson has also held several prominent industry roles as a past President of ACCORD Australasia Limited, a former Vice Chairman of the Australian Food and Grocery Council and a former member of the board of ASMI. Mr Johnson has had extensive overseas experience during his career in leading businesses in both Western and Central-Eastern Europe, Africa as well as Asia-Pacific. Mr Johnston is also a member of the MVP Audit & Risk Committee. Mr L Hoare Non-Executive Director (since 27 September 2013) Mr Hoare is the Managing Director of Smith & Nephew in Australia & New Zealand (covering all Divisions), which is one of the largest global subsidiaries (outside the USA). In his 24 years with Smith & Nephew, he has held roles in Marketing, Divisional and General Management, and was most recently Asia Pacific President of the Advanced Wound Management 22 Medical Developments International Limited(AWM) Division, before advancing to the Managing Director role in 2014. He has also been a member of the Global Executive Management for the AWM Division of Smith & Nephew whilst leading Asia Pacific. External to Smith & Nephew, Mr Hoare previously held board roles (including as Vice-Chair) with Australia’s peak medical device body, Medical Technology Association of Australia (MTAA). Mr P J Powell, B.Com (Hons) ACA, F Fin, MAICD Non-Executive Director (appointed 17 December 2014) Mr Powell, a Chartered Accountant, has an extensive finance background and commenced working in investment banking in 1996 at Hambros Corporate Finance following ten years industry experience in senior finance roles with ASX listed public company OAMPS Limited. Prior to these roles, he worked for ten years within the Assurance Division at Arthur Andersen & Co. From January 2006 to July 2013 he was an Executive Director at Corporate Finance Advisory firm Kidder Williams. Philip is also a Non-executive Director of PolyNovo Limited (ASX:PNV). Philip is Chairman of MVP’s Audit and Risk Committee. The above named directors held office during and since the end of the financial year. Mr M Van Ryn, B.Bus Non-Executive Director (resigned 28 July 2014) Mr Van Ryn has over 35 years experience in the direct management of food companies and has extensive experience in launching and marketing products into international markets. Prior to his resignation from the Board on 28 July 2014, Mr Van Ryn was also the Chairman of the Audit & Risk Committee. Directorships of other listed companies Directorships of other listed companies held by the directors in the 3 years immediately before the end of the financial year are as follows: NAME COMPANY PERIOD OF DIRECTORSHIP David Williams Polynovo Limited Since 13 March 2014 (Chairman) IDT Australia Resigned on 19 May 2015 Allan McCallum Tassal Group Ltd (Chairman) Since October 2003 Max Johnston Probiotec Ltd Since April 2010 Enero Group Limited Since March 2011 Polynovo Limited Since 13 May 2014 Philip Powell Polynovo Limited Since 13 May 2014 Company Secretary Mr Mark Edwards, CA. Mr Edwards is also the Group Financial Controller of the company. Principal Activities The company’s principal activities during the course of the financial year were the manufacture and distribution of a pharmaceutical drug and medical and veterinary equipment. Review of Operations FY15 was a year of significant investment in the future of our business. The investment in our regulatory, sales, manufacturing, product development and research teams was significant. Pharmaceuticals All segments of our Penthrox® business performed strongly and sales of Penthrox® grew 32% compared to FY14. Sales to our Ambulance business grew by 22% and sales to Hospitals and General Practitioners grew 32%. Sales for our Dental business grew 67% which is the result of our business partner expanding our presence in this market. Internationally we made our first sales to South Africa in FY15. We expect South Africa to be a significant market for Penthrox®. Sales in the Middle East grew 118%. Clinical Developments MVP continues its program of developing applications for Penthrox®. Additional clinical trials are planned which may open up new areas of use for Penthrox®. During the year we have directly and indirectly progressed the following clinical studies: • A psychomotor function study undertaken at Royal Adelaide Hospital aimed at demonstrating that the use of Penthrox® would not impair a patient’s ability to drive or operate machinery is in its final stages with patient recruitment completed in June 2015. The results indicate Penthrox® induces an acute but short-lasting impairment of psychomotor and cognitive performance, which returns to normal within 30 minutes after inhalation. This is a significant result for Penthrox® and means that patients do not require longer term monitoring after the administration of Penthrox®, and patients can be safely returned to tasks that require high psychomotor skills such as driving 30 minutes after cessation of Penthrox®, which is a very significant advantage over all of its narcotic competitors. t r o p e R ’ s r o t c e r i D 23 Annual Financial Report 2015 • An active comparative trial in Singapore, which AUSTRALIA compares the benefits of intramuscular Tramadol v Penthrox® in an Ambulance setting. This trial is progressing well with recruitment having been completed. Interim results are very positive for Penthrox® and we expect this trial will be completed towards the end of 2015. • We are developing three additional clinical trials in 2015 which will support our marketing efforts in Europe and elsewhere. Domestically, sales to Ambulance increased 22% during the year due to grow across all mainland states and territories. Medical Devices: Respiratory Overall Respiratory sales have increased 42% in FY15. Commercialisation AUSTRALIA SOUTH AFRICA After receiving approval to sell Penthrox® in South Africa in June 2014, we made our first sales to South Africa in FY15. We expect South Africa will be a significant market for Penthrox® and should grow significantly in FY16. EUROPE MVP is finalising contracts with a significant pharmaceutical company having expertise in pain management products to distribute Penthrox®. UK AND IRELAND MVP entered into an exclusive Distribution, License and Supply Agreement with Galen Limited to supply Penthrox® in the United Kingdom and Ireland. Sales to Galen are expected in the first half of FY16. USA MVP has commenced the process of reviewing the necessary steps to get Penthrox® approved for sale in the USA including the appointment of professional advisors. The USA approval will become a key priority in FY16 and beyond. RUSSIA We have been working on our Russian Registration Dossier to have Penthrox® approved for sale In Russia for more than two years. The Russian Registration Dossier has been reviewed by experts and our application lodged with the Ministry of Health for Russia. EASTERN EUROPE AND MIDDLE EAST We have achieved very significant sales success in the Middle East. Our business grew by 118% and is showing signs of further growth potential in FY16. In Eastern Europe our business performed below expectations with sales falling 17%. This is mainly due to the political unrest in the region and we expect this business to recover in FY16. Our Australian respiratory business has rebounded well from a difficult FY14 and with sales increasing 13%. Much of FY15 growth can be attributed to our spacer range now being stocked in Australia’s two largest retail pharmacy chains. NORTH AMERICA Our North American Respiratory business has grown significantly in FY15, increasing by 593% as a result of our distributors success in winning more tenders and increasing their range of MVP respiratory products sold in the market. Our “anti-static” Compact Space Chamber Plus products are expected to be approved by the FDA shortly and having a full range of our respiratory products approved and available for sale is expected to deliver further significant growth in FY16. Our initial assessment of the USA market is that there are approximately 20 million space chamber devices sold each year. Our products are amongst the world’s best and our ambition is to win significant market share over the coming years. EUROPE Our business in Europe (including the UK) was profitable for the first time since established. Respiratory sales grew 172% in FY15. During FY15, MVP entered into an exclusive agreement with PSUK to supply its range of respiratory devices in the UK. The agreement includes minimum quantities for 3 years that will drive ongoing sales growth of respiratory devices in the UK. PSUK supply the majority of doctors and pharmacies in the UK with medical devices. We have also made progress on mainland Europe with sales growing 93%. We expect further very significant sales and profitability growth in our European/UK Respiratory Device business during FY16. NEW ZEALAND Our New Zealand business grew 17% in FY15. 24 Medical Developments International LimitedASIA We have increased our presence and marketing efforts throughout Asia and sales into this region grew 8% year on year. We expect further growth in FY16. Vet Our Vet business declined 11% in FY15. However we achieved a significant improvement in H2FY15 because we opened new markets in China and South East Asia. Our increased sales efforts and continued fall in the Australian dollar is expected to further help our export business in FY16. Research and Development During FY15 we completed the final stage of constructing our commercial scale plant for the new methoxyflurane manufacturing process. Three validation batches using the new process were completed under production conditions. This initiative will revolutionise our manufacturing process and transform the cost base for Penthrox®. In addition to valuable intellectual property, this project will create ongoing options for innovation and growth which previously did not exist. Operating Expenses During the year, the Company invested heavily in our regulatory, product development, sales, marketing and research and development teams. The investment in clinical studies, research and development and product development has been capitalised to intangible assets where appropriate. The Company will invest in additional studies in FY16 to support both the European registration and the company plans to pursue opportunities in North America. We received a $0.282 million R&D tax incentive refund during the year and a further $0.133 million is expected in the coming months in relation to FY15. Dividend No dividends are declared. Outlook Our ambition is to make Penthrox® a main stream analgesic of choice around the world and our Respiratory Devices leaders in the field. Penthrox® is a category leading drug in Australia and we expect it can dominate many of the trauma and minor surgical procedure markets around the world. With the completion of our Regulatory Dossier, a number of licensing deals successfully concluded and with the successful completion of our CSIRO manufacturing project, we have the base to make MVP a global pharmaceutical company. The growth experienced in asthma device sales in FY15 will be built on in FY16 as a result of growth within existing customer accounts, new product registrations and new overseas market opportunities in the USA and Europe. FY15 has been an improved year in terms of sales and profit. However FY16 and beyond should see the flow through results of new global registrations, licensing deals and recent staff hires, combining to deliver further sales and profit growth. Financial Position The capital structure of the Group remained stable during the period. • Interest bearing liabilities at 30 June 2015 total $1,111,000; and • The key financial covenants attached to this debt facility include current, debt cover and operating leverage ratios and there are no forecasted breaches in the coming 12 month period. Changes in State of Affairs During the financial year there was no significant change in the state of affairs of the company other than that referred to in the financial statements or notes thereto. Subsequent Events There has not been any matter or circumstance that has arisen that has significantly affected, or may significantly affect the operations of the company, the results of those operations, or the state of affairs of the company in future years. t r o p e R ’ s r o t c e r i D 25 Annual Financial Report 2015 Dividends There were no dividends declared for the full year ended 30 June 2015. Indemnification of Officers and Auditors During the financial year, the company paid a premium in respect of a contract insuring the directors of the company (as named above), and all executive officers of the company against a liability incurred as such a director, secretary or executive officer to the extent permitted by the Corporations Act 2001. The contract of insurance prohibits disclosure of the nature of the liability and the amount of the premium. The company has not otherwise, during or since the end of the financial year, indemnified or agreed to indemnify an officer or auditor of the company against a liability incurred as such an officer or auditor. attended by each director (while they were a director or committee member). During the financial year, 8 board meetings, 2 audit and risk committee meetings and 1 remuneration and nominations committee meeting were held. Mr Williams joined the Audit and Risk Committee in July 2014 and resigned in December 2014 and therefore was only eligible to attend 1 meeting. Mr Powell joined the Board in December 2014 and was therefore only eligible to attend 6 meetings. Mr Powell also joined the Audit and Risk Committee in December 2014 and therefore was only eligible to attend 1 meeting. Directors’ Shareholdings The following table sets out each director’s relevant interest in shares as at the date of this report. 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 D.J. Williams A.D. McCallum H.F. Oxer M. Johnston L. Hoare P.J. Powell FULLY PAID SHARES 23,371,990 477,497 207,013 30,000 10,000 352,074 BOARD OF DIRECTORS AUDIT & RISK COMMITTEE REMUNERATION & NOMINATIONS HELD ATTENDED HELD ATTENDED HELD ATTENDED D.J. Williams A.D. McCallum H.F. Oxer M. Johnston L. Hoare P.J. Powell 8 8 8 8 8 6 8 8 7 8 8 5 1 - - 2 - 1 1 - - 2 - 1 1 1 - - - - 1 1 - - - - 26 Medical Developments International LimitedAudited Remuneration Report KEY MANAGEMENT PERSONNEL DETAILS The company’s key management personnel consist of the following directors and executives: This remuneration report, which forms part of the directors’ report, sets out information about the remuneration of Medical Developments International Limited’s key management personnel for the financial year ended 30 June 2015. The term ‘key management personnel’ refers to those persons having authority and responsibility for planning, directing and controlling the activities of the consolidated entity, directly or indirectly, including any director (whether executive or otherwise) of the consolidated entity. The prescribed details for each person covered by this report are detailed below under the following headings: • Key management personnel • Remuneration policy • Relationship between the remuneration policy and company performance • Remuneration of key management personnel • Key terms of employment contracts. The directors of the company during or since the end of the financial year were: • D.J. Williams (Chairman, Non-executive) • H. F. Oxer (Non-executive) • A.D. McCallum (Non-executive) • M. Van Ryn (Non-executive) (resigned 28 July 2014) • R.M. Johnston (Non-executive) • L. Hoare (Non-executive) • P. Powell (non-executive) (appointed 17 December 2014) The company executives during or since the end of the financial year were: • J. Sharman (Chief Executive Officer) • M. Edwards (Company Secretary) Except as noted, the named persons held their current position for the whole of the financial year and since the end of the financial year. Key management personnel equity holdings – fully paid ordinary shares 2015 D.J. Williams A.D. McCullum H.F. Oxer M. Johnston L. Hoare P.J. Powell* J. Sharman M. Edwards BALANCE AT 30 JUNE 2014 No. ISSUED DURING THE YEAR No. NET OTHER CHANGE No. BALANCE AT 30 JUNE 2015 No. 30,370,890 477,497 207,013 30,000 - - 609,230 - 31,694,630 - - - - - - - - - (6,998,900) 23,371,990 - - - 10,000 352,074 (500,000) - 477,497 207,013 30,000 10,000 352,074 109,230 - (7,136,826) 24,557,804 * Mr. Powell joined the Board on 17 December 2014 and at that time indirectly held 352,074 shares. 2014 D.J. Williams A.D. McCallum H.F. Oxer M. Van Ryn M. Johnston L. Hoare J. Sharman M. Edwards BALANCE AT 30 JUNE 2013 No. ISSUED DURING THE YEAR No. NET OTHER CHANGE No. BALANCE AT 30 JUNE 2014 No. 30,202,225 470,095 203,804 1,321,029 20,000 - 769,230 - 32,986,383 - - - - - - - - - 168,665 30,370,890 7,402 3,209 5,057 10,000 - (160,000) - 34,333 477,497 207,013 1,326,086 30,000 - 609,230 - 33,020,716 t r o p e R ’ s r o t c e r i D 27 Annual Financial Report 2015 REMUNERATION POLICY Net Profit After Tax 2010 - 2015 The board continues to set remuneration at a level that will attract directors and executives of high calibre. The two key elements are: • base salary and fees, which are determined by reference to the market rate based on payments at similar sized companies in the industry; and • Performance incentives, which have two components – short term incentives based on achieving key performance indicators during the year and payable in cash, and long-term incentives payable in equity, the value of which depends on the share price of the company. The remuneration and nominations committee, comprised of D.J. Williams and A.D. McCallum, determines the salary package of the CEO of the company and reviews the compensation of the non-executive directors on an annual basis. Changes are approved by the board as a whole. RELATIONSHIP BETWEEN THE REMUNERATION POLICY AND COMPANY PERFORMANCE The board aims to ensure there is a strong link between company performance and remuneration and believes that the use of performance incentives ensures that company performance is reflected in the quantum of payments made to executives. Performance metrics are selected to ensure that the interests of management are aligned with those of shareholders. For short term incentives, key metrics are NPAT (net profit after tax), used to directly link company earnings and cash bonuses and other operational measures, the achievement of which provides the basis for future growth and profitability. The table below and graph depict the company’s earnings for the current financial year and the previous five financial years, which demonstrate that the company has been consistently profitable. YEARS 2010 $’000 2011 $’000 2012 $’000 2013 $’000 2014 $’000 2015 $’000 3,000 2,500 2,000 0 0 0 ’ $ 1,500 1,000 500 2010 2011 2012 2013 2014 2015 The following table shows the company’s share prices for the current financial year and the previous four financial years. 2010 2011 2012 2013 2014 2015 Share price - start ($) 0.18 0.22 0.40 0.79 1.27 1.32 Share price - end ($) 0.22 0.40 0.79 1.27 1.32 2.68 Interim Dividend (cps)* Final Dividend (cps)* - - - 3.00 3.00 3.00 3.00 2.00 - - - - Basic Earnings per share (cps) 1.70 3.40 5.10 4.10 1.50 2.64 Diluted Earnings per Share (cps) 1.70 3.40 5.10 4.10 1.50 2.64 *Franked to 100% at 30% corporate income tax rate. DIVIDENDS There has been no dividend declared for the full year ended 30 June 2015. ELEMENTS OF DIRECTOR AND EXECUTIVE REMUNERATION Remuneration packages contain the following key elements: 1. Primary benefits – salary/fees and cash bonuses 2. Post-employment benefits – superannuation 3. Equity – rights to shares granted under the Chief Revenue 8,296 10,206 11,313 11,733 9,370 11,608 Executive Officer Long Term Incentive Plan (CEO LTIP). NPBT NPAT 1,273 2,495 3,789 3,192 879 1,743 2,704 2,309 641 875 2,176 1,529 28 Medical Developments International Limited The following table discloses the remuneration of the directors of the company in 2015: 2015 Directors D.J. Williams A.D. McCallum H.F. Oxer M. Van Ryn (resigned 28 July 2014) M. Johnston L. Hoare SHORT-TERM EMPLOYEE BENEFITS POST EMPLOY- MENT LONG-TERM EMPLOYEE BENEFITS SHARE- BASED PAYMENTS TOTAL SALARY & FEES BONUS SUPER- ANNUATION LONG SERVICE LEAVE OPTIONS & RIGHTS $ 54,795 34,247 34,247 2,854 34,247 34,247 $ - - - - - - - $ 5,205 3,253 3,253 271 3,253 3,253 6,928 $ - - - - - - - - $ - - - - - - - - $ 60,000 37,500 37,500 3,125 37,500 37,500 19,771 232,896 P.J. Powell (appointed 17 December 2014) 12,843 207,480 25,416 The following table discloses the remuneration of the key executives of the company in 2015: 2015 Executives J. Sharman (Chief Executive Officer) M. Edwards (Company Secretary) SHORT-TERM EMPLOYEE BENEFITS POST EMPLOY- MENT LONG-TERM EMPLOYEE BENEFITS SHARE- BASED PAYMENTS TOTAL SALARY & FEES BONUS SUPER- ANNUATION LONG SERVICE LEAVE OPTIONS & RIGHTS $ 275,132 141,876 417,008 $ - - - $ $ 24,868 13,478 38,346 8,161 277 8,438 $ - - - $ 308,161 155,631 463,792 The following table discloses the remuneration of the directors of the company in 2014: 2014 Directors D.J. Williams A.D. McCallum H.F. Oxer* M. Van Ryn (resigned 28 July 2014) M. Johnston SHORT-TERM EMPLOYEE BENEFITS POST EMPLOY- MENT LONG-TERM EMPLOYEE BENEFITS SHARE- BASED PAYMENTS TOTAL SALARY & FEES BONUS SUPER- ANNUATION LONG SERVICE LEAVE OPTIONS & RIGHTS $ 54,919 34,325 56,293 34,325 34,325 $ - - - - - - - $ 5,080 3,175 5,207 3,175 3,175 2,406 22,218 $ - - - - - - - $ - - - - - - - $ 59,999 37,500 61,500 37,500 37,500 28,414 262,413 L. Hoare (appointed 27 September 2013) 26,008 240,195 *Dr Oxer’s remuneration includes Directors Fees ($37,500) and Medical Consultant Fees ($24,000). t r o p e R ’ s r o t c e r i D 29 Annual Financial Report 2015 The following table discloses the remuneration of the key executives of the company in 2014: 2014 SHORT-TERM EMPLOYEE BENEFITS POST EMPLOY- MENT LONG-TERM EMPLOYEE BENEFITS SHARE- BASED PAYMENTS TOTAL SALARY & FEES BONUS SUPER- ANNUATION LONG SERVICE LEAVE OPTIONS & RIGHTS Executives J. Sharman (Chief Executive Officer) W. Gouveia (Company Secretary, resigned 23 October 2013)* A. Manhire (Company Secretary, appointed 25 November 2013, resigned 10 June 2014)* M. Edwards (Company Secretary, appointed 10 June 2014) $ 276,007 49,231 70,654 10,732 $ - 4,577 - - $ $ 24,296 4,400 6,197 993 6,187 - - 8 406,624 4,577 35,886 6,195 * Included in Mrs Gouveia’s remuneration are termination benefits of $6,536 disclosed as part of Salaries & Fees. * Included in Mr Manhire’s remuneration are termination benefits of $3,636 disclosed as part of Salaries & Fees. $ - - - - - $ 306,490 58,208 76,851 11,732 453,282 With exception of Mrs Gouviea whose remuneration comprised of an 8% performance related component, no other director or key management personnel remuneration contained a performance related component. No key management personnel appointed during the period received a payment as part of his or her consideration for agreeing to hold the position. ELEMENTS OF REMUNERATION RELATED TO PERFORMANCE Fees paid to non-executive directors are not directly tied to performance. Salaries paid to the key executives are also not directly tied to performance. The short term and long-term incentive programmes are directly related to performance, and the conditions and assessment methods are explained below. Short-term incentives The determination and approval of any potential bonuses is at the discretion of the Board. During the 2015 financial year, discretionary bonuses totalling $nil (2014: $4,577) were determined and approved by the Remuneration and Nominations Committee in relation to key management personnel in respect of their performance in the 2014 financial year. Contracts for services Mr Sharman is employed under an open-ended contract with a notice period of three months. The contract does not provide for any termination payments beyond payment for the notice period and any accrued annual leave. Mr Edwards is employed under an open-ended contract with a notice period of four weeks. The contract does not provide for any termination payments beyond payment for the notice period and any accrued annual leave. NON-AUDIT SERVICES The directors are satisfied that the provision of non-audit services, during the year, by the auditor (or by another person or firm on the auditor’s behalf) is compatible with the general standard of independence for auditors imposed by the Corporations Act 2001. The non-audit services related to the provision of taxation and other accounting and assurance services and totalled $48,800. The directors do not believe that the provision of advice of this nature compromises the general principles relating to auditor’s independence, as set out by the Institute of Chartered Accountants in Australia. Details of amounts paid or payable to the auditor for non- audit services provided during the year by the auditor are outlined in note 7 to the financial statements. 30 Medical Developments International LimitedAUDITOR’S INDEPENDENCE DECLARATION The auditor’s independence declaration is included on page 32 of the annual report. ROUNDING OFF OF AMOUNTS The company is a company of the kind referred to in ASIC Class Order 98/0100, dated 10 July 1998, and in accordance with that Class Order amounts in the directors’ report and the financial report are rounded off to the nearest thousand dollars unless otherwise indicated. Signed in accordance with a resolution of the directors made pursuant to s.298(2) of the Corporations Act 2001. On behalf of the directors. MR DAVID WILLIAMS CHAIRMAN Melbourne, 21 August 2015 t r o p e R ’ s r o t c e r i D 31 Annual Financial Report 2015 32 Medical Developments International Limited33 Annual Financial Report 201534 Medical Developments International LimitedDirectors’ Declaration The directors declare that: a) b) 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; 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 consolidated entity; c) the attached financial statements are in compliance with International Financial Reporting Standards, as stated in note 1 of the financial statements; and d) the directors have been given the declarations required by s.295A of the Corporations Act 2001. 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 MR DAVID WILLIAMS CHAIRMAN Melbourne, 21 August 2015 n o i t a r a c e D l ’ s r o t c e r i D 35 Annual Financial Report 2015 Statement of Comprehensive Income Consolidated Statement of Profit or Loss and Other Comprehensive Income for the Financial Year Ended 30 June 2015 Revenue from sale of goods Cost of sales Gross profit Other income Distribution expenses Marketing expenses Occupancy expenses Administration expenses Regulatory and registration expenses Finance expenses Other expenses Profit before income tax expense Income tax (expense)/benefit Profit for the year Other Comprehensive Income NOTE 4(a) 4(a) 5(a) Items that may be reclassified subsequently to profit or loss, net of income tax Exchange differences on translating foreign operations 21 Total comprehensive income for the year Profit for the year attributable to: Owners of the parent Total comprehensive income for the year attributable to: Owners of the parent Earnings per Share: Basic (cents per share) Diluted (cents per share) 23 23 Notes to the financial statements are included on pages 40-64 36 2015 $’000 11,608 (3,554) 8,054 116 (587) (1,165) (396) (2,030) (791) (81) (944) 2,176 (647) 1,529 54 1,583 1,529 1,583 2.6 2.6 2014 $’000 9,370 (3,050) 6,320 47 (516) (1,560) (390) (1,742) (960) (156) (402) 641 234 875 (20) 855 875 855 1.5 1.5 Medical Developments International Limited Statement of Financial Position Consolidated Statement of Financial Position as at 30 June 2015 Current Assets Cash and cash equivalents Trade and other receivables Inventories Current tax assets Other Total Current Assets Non-Current Assets Property, plant and equipment Deferred tax assets Goodwill Other intangible assets Total Non-Current Assets Total Assets Current Liabilities Trade and other payables Borrowings Provisions Current tax liabilities Total Current Liabilities Non-Current Liabilities Deferred tax liabilities Borrowings Provisions Other Total Non-Current Liabilities Total Liabilities Net Assets Equity Issued capital Reserves Retained earnings Total Equity Notes to the financial statements are included on pages 40-64 NOTE 29(a) 8 9 5(c) 10 12 5(d) 13 14 15 16 17 5(c) 5(e) 16 18 19 20 21 22 30 JUNE 2015 30 JUNE 2014 $’000 954 1,819 1,887 - 175 4,835 1,522 143 7,368 9,120 18,153 22,988 1,231 92 215 294 1,832 1,703 1,019 93 934 3,749 5,581 17,407 10,946 21 6,440 17,407 $’000 1,659 1,808 1,446 512 153 5,578 1,125 104 7,368 8,385 16,982 22,560 1,092 3,089 180 - 4,361 1,414 573 70 318 2,375 6,736 15,824 10,946 (33) 4,911 15,824 37 Annual Financial Report 2015 Statement of Changes in Equity Consolidated Statement of Changes in Equity for the Financial Year Ended 30 June 2015 ISSUED CAPITAL RETAINED EARNINGS $’000 10,946 - - - - - $’000 4,911 1,529 - 1,529 - - 10,946 6,440 FOREIGN CURRENCY TRANSLATION RESERVE $’000 (33) - 54 54 - - - 21 ISSUED CAPITAL RETAINED EARNINGS FOREIGN CURRENCY TRANSLATION RESERVE $’000 10,559 - - - - - 387 - - 10,946 $’000 5,183 875 - 875 - - (387) (760) - 4,911 $’000 (13) - (20) (20) - - - - - (33) TOTAL $’000 15,824 1,529 54 1,583 - - - 17,407 TOTAL $’000 15,729 875 (20) 855 - - - (760) - 15,824 2015 Opening balance Profit for the year Other comprehensive income for the year, net of income tax Total comprehensive income for the year Dividends reinvested in the form of shares Dividends paid Transfer to retained earnings Closing balance Finacial year ended 30 June 2014 2014 Opening balance Profit for the year Other comprehensive income for the year, net of income tax Total comprehensive income for the year Share based payment Shares subscribed for under CEO LTIP Dividends reinvested in the form of shares Dividends paid Transfer to retained earnings Closing balance Notes to the financial statements are included on pages 40-64 38 Medical Developments International LimitedStatement of Cash Flows Consolidated Statement of Cash Flows for the Financial Year Ended 30 June 2015 NOTE Cash flows from operating activities Receipts from customers Payments to suppliers and employees Receipts from government grants Other income Interest paid Income tax received Net cash generated by operating activities 29(b) Cash flows from investing activities Interest received Payments for plant and equipment Payments for other intangible assets Net cash used in investing activities Cash flows from financing activities Dividends paid Proceeds from/(payment for) hire purchase finance Proceeds from/(repayment of) borrowings Net cash (used in)/generated by financing activities Net (decrease)/increase in cash and cash equivalents 24 16 16 Cash and cash equivalents at the beginning of the financial year Effects of exchange rate changes on the balance of cash held in foreign currencies Cash and cash equivalents at the end of the financial year 29(a) Notes to the financial statements are included on pages 40-64 2015 $’000 12,135 (9,245) 111 - (65) 423 3,359 5 (555) (957) (1,507) - (46) (2,534) (2,580) (728) 1,659 23 954 2014 $’000 10,060 (9,128) - 25 (156) 494 1,295 22 (322) (1,537) (1,837) (760) 144 2,075 1,459 917 768 (26) 1,659 39 Annual Financial Report 2015Notes to the Financial Statements for the Financial Year Ended 30 June 2015 1. Significant accounting policies STATEMENT OF COMPLIANCE The financial report is a general purpose financial report which has been prepared in accordance with the Corporations Act 2001, Australian Accounting Standards and Interpretations, and complies with other requirements of the law. The financial statements comprise the consolidated financial statements of the Group. For the purposes of preparing the consolidated financial statements, the Company is a for-profit entity. Accounting Standards include Australian Accounting Standards. Compliance with Australian Accounting Standards ensures that the financial statements and notes of the company comply with International Financial Reporting Standards (‘IFRS’). The financial statements were authorised for issue by the directors on 21 August 2015. BASIS OF PREPARATION The consolidated financial statements have been prepared on the basis of historical cost, except for certain non- current assets and financial instruments that are measured at revalued amounts or fair values, as explained in the accounting policies below. Historical cost is generally based on the fair values of the consideration given in exchange for goods and services. All amounts are presented in Australian dollars, unless otherwise noted. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, regardless of whether that price is directly observable or estimated using another valuation technique. In estimating the fair value of an asset or a liability, the Group takes into account the characteristics of the asset or liability if market participants would take those characteristics into account when pricing the asset or liability at the measurement date. Fair value for measurement and/or disclosure purposes in these consolidated financial statements is determined on such a basis, except for share-based payment transactions that are within the scope of AASB 2, leasing transactions that are within the scope of AASB 117, and measurements that have some similarities to fair value but are not fair value, such as net realisable value in AASB 2 or value in use in AASB 136. In addition, for financial reporting purposes, fair value measurements are categorised into Level 1, 2 or 3 based on the degree to which the inputs to the fair value measurements are observable and the significance of the inputs to the fair value measurement in its entirety, which are described as follows: • • • Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the entity can access at the measurement date; Level 2 inputs are inputs, other than quoted prices included within Level 1, that are observable for the asset or liability, either directly or indirectly; and Level 3 inputs are unobservable inputs for the asset or liability. The company is a company of the kind referred to in ASIC Class Order 98/0100, dated 10 July 1998, and in accordance with that Class Order amounts in the financial report are rounded off to the nearest thousand dollars, unless otherwise noted. BASIS OF CONSOLIDATION The consolidated financial statements incorporate the financial statements of the Company and entities (including special purpose entities) controlled by the Company (its subsidiaries). Control is achieved where the Company has the power to govern the financial and operating policies of an entity so as to obtain benefits from its activities. 40 Medical Developments International LimitedIncome and expense of subsidiaries acquired or disposed of during the year are included in the consolidated statement of profit or loss and other comprehensive income from the effective date of acquisition and up to the effective date of disposal, as appropriate. Total comprehensive income of subsidiaries is attributed to the owners of the Company and to the non-controlling interests even if this results in the non- controlling interests having a deficit balance. Where necessary, adjustments are made to the financial statements of subsidiaries to bring their accounting policies into line with those used by other members of the Group. All intra-group transactions, balances, income and expenses are eliminated in full on consolidation. Changes in the Group’s ownership interests in subsidiaries that do not result in the Group losing control are accounted for as equity transactions. The carrying amounts of the Group’s interests and the non-controlling interests are adjusted to reflect the changes in their relative interests in the subsidiaries. Any difference between the amount by which the non-controlling interests are adjusted and the fair value of the consideration paid or received is recognised directly in equity and attributed to owners of the Company. SIGNIFICANT ACCOUNTING POLICIES The following significant accounting policies have been adopted in the preparation and presentation of the financial report: Liabilities recognised in respect of annual leave and long service leave which are not expected to be settled within 12 months are measured using an estimate of the present value of the future cash outflows to be made by the company in respect of services provided by employees up to reporting date. (d) Financial assets LOANS AND RECEIVABLES Trade receivables, loans, and other receivables that have fixed or determinable payments that are not quoted in an active market are classified as ‘loans and receivables’. Loans and receivables are measured at amortised cost using the effective interest rate method less impairment. Interest income is recognised by applying the effective interest rate. IMPAIRMENT OF FINANCIAL ASSETS Financial assets, other than those at fair value through profit and loss, are assessed for indicators of impairment at each balance sheet date. Financial assets are impaired where there is objective evidence that as a result of one or more events that occurred after the initial recognition of the financial asset, the estimated future cash flows of the investment have been impacted. (e) Financial instruments issued by the company (a) Borrowings DEBT AND EQUITY INSTRUMENTS Borrowings are recorded initially at fair value, net of transaction costs. Subsequent to initial recognition, borrowings are measured at amortised cost with any difference between the initial recognised amount and the redemption value being recognised in profit and loss over the period of the borrowing using the effective interest rate method. (b) Cash and cash equivalents Cash and cash equivalents comprise cash on hand, cash in banks and investments in money market instruments, net of outstanding bank overdrafts. (c) Employee benefits A liability is recognised for benefits accruing to employees in respect of wages and salaries, annual leave, long service leave, and sick leave when it is probable that settlement will be required and they are capable of being measured reliably. Liabilities recognised in respect of wages and salaries, annual leave and sick leave expected to be settled within 12 months, are measured at their nominal values using the remuneration rate expected to apply at the time of settlement. Debt and equity instruments are classified as either liabilities or as equity in accordance with the substance of the contractual arrangement. TRANSACTION COSTS ON THE ISSUE OF EQUITY INSTRUMENTS Transaction costs arising on the issue of equity instruments are recognised directly in equity as a reduction of the proceeds of the equity instruments to which they relate. Transaction costs are the costs that are incurred directly in connection with the issue of those equity instruments and would not have been incurred had those instruments not been issued. INTEREST AND DIVIDENDS Interest and dividends are classified as expenses or as distributions of profit consistent with the balance sheet classification of the related debt or equity instruments or component parts of compound instruments. (f) Foreign currency The individual financial statements of each group entity are presented in the currency of the primary economic environment in which the entity operates (its functional t n e m e t a t S l i a c n a n F i e h t o t s e t o N 41 Annual Financial Report 2015 currency). For the purpose of the consolidated financial statements, the results and financial position of each group entity are expressed in Australian dollars (‘$’), which is the functional currency of the Company and the presentation currency for the consolidated financial statements. • for receivables and payables which are recognised inclusive of GST. The net amount of GST recoverable from, or payable to, the taxation authority is included as part of receivables or payables. In preparing the financial statements of each individual group entity, transactions in currencies other than the entity’s functional currency (foreign currencies) are recognised at the rates of exchange prevailing at the dates of the transactions. At the end of each reporting period, monetary items denominated in foreign currencies are retranslated at the rates prevailing at that date. Non-monetary items carried at fair value that are denominated in foreign currencies are retranslated at the rates prevailing at the date when the fair value was determined. Non-monetary items that are measured in terms of historical cost in a foreign currency are not retranslated. Exchange differences on monetary items are recognised in profit or loss in the period in which they arise, except for: • • • exchange differences on foreign currency borrowings relating to assets under construction for future productive use, which are included in the cost of those assets when they are regarded as an adjustment to interest costs on those foreign currency borrowings; exchange differences on transactions entered into in order to hedge certain foreign currency risks below for hedging accounting policies; and exchange differences on monetary items receivable from or payable to a foreign operation for which settlement is neither planned nor likely to occur (therefore forming part of the net investment in the foreign operation), which are recognised initially in other comprehensive income and reclassified from equity to profit or loss on repayment of the monetary items. For the purpose of presenting consolidated financial statements, the assets and liabilities of the Group’s foreign operations are translated into Australian dollars using exchange rates prevailing at the end of the reporting period. Income and expense items are translated at the average exchange rates for the period, unless exchange rates fluctuated significantly during that period, in which case the exchange rates at the dates of the transactions are used. Exchange differences arising, if any, are recognised in other comprehensive income and accumulated in equity (attributed to non-controlling interests as appropriate). (g) Goods and services tax Revenues, expenses and assets are recognised net of the amount of goods and services tax (GST), except: • where the amount of GST incurred is not recoverable from the taxation authority, it is recognised as part of the cost of acquisition of an asset or as part of an item of expense; or Cash flows are included in the Consolidated Statement of Cash Flows on a gross basis. The GST component of cash flows arising from investing and financing activities which is recoverable from, or payable to, the taxation authority is classified as operating cash flows. (h) 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 is recognised immediately in the Consolidated Statement of Profit or Loss and Other Comprehensive Income and is not subsequently reversed. Refer also to note 1(j). (i) Government grants Government grants are assistance by the government in the form of transfers of resources to the company in return for past or future compliance with certain conditions relating to the operating activities of the company. Government grants include government assistance where there are no conditions specifically relating to the operating activities of the company other than the requirement to operate in certain regions or industry sectors. Government grants relating to income are recognised as income over the periods necessary to match them with the related costs. Government grants that are receivable as compensation for expenses or losses already incurred or for the purpose of giving immediate financial support to the company with no future related costs are recognised as income of the period in which it becomes receivable. Government grants relating to assets are treated as deferred income and recognised in the profit and loss over the expected useful lives of the assets concerned. (j) Impairment of assets At each reporting date, the company reviews the carrying amounts of its tangible and intangible assets to determine whether there is any indication that those assets have suffered an impairment loss. If any such indication exists, the recoverable amount of the asset is estimated in order to determine the extent of the impairment loss (if any). Where the asset does not generate cash flows that are independent from other assets, the company estimates the recoverable amount of the cash generating unit to which the asset belongs. 42 Medical Developments International LimitedGoodwill, intangible assets with indefinite useful lives 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. An impairment of goodwill is not subsequently reversed. Recoverable amount is the higher of fair value less costs to sell and value in use. 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 for which the estimates of future cash flows have not been adjusted. recognised to the extent that it is probable that sufficient taxable amounts will be available against which deductible temporary differences or unused tax losses and tax offsets can be utilised. However, deferred tax assets and liabilities are not recognised if the temporary differences giving rise to them arise from the initial recognition of assets and liabilities (other than as a result of a business combination) which affects neither taxable income nor accounting profit. Furthermore, a deferred tax liability is not recognised in relation to taxable temporary differences arising from goodwill. 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, unless the relevant asset is carried at fair value, in which case the impairment loss is treated as a revaluation decrease. 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, unless the relevant asset is carried at fair value, in which case the reversal of the impairment loss is treated as a revaluation increase. (k) Income tax CURRENT TAX Deferred tax assets and liabilities are measured at the tax rates that are expected to apply to the period(s) when the asset and liability giving rise to them are realised or settled, based on tax rates (and tax laws) that have been enacted or substantively enacted by reporting date. The measurement of deferred tax liabilities and assets reflects the tax consequences that would follow from the manner in which the company expects, at the reporting date, to recover or settle the carrying amount of its assets and liabilities. Deferred tax assets and liabilities are offset when they relate to income taxes levied by the same taxation authority and the company intends to settle its current tax assets and liabilities on a net basis. CURRENT AND DEFERRED TAX FOR THE PERIOD Current and deferred tax is recognised as an expense or income in the Consolidated Statement of Profit or Loss and Other Comprehensive Income, except when it relates to items credited or debited directly to equity, in which case the deferred tax is also recognised directly in equity, or where it arises from the initial accounting for a business combination, in which case it is taken into account in the determination of goodwill or excess. Current tax is calculated by reference to the amount of income taxes payable or recoverable in respect of the taxable profit or loss for the period. It is calculated using tax rates and tax laws that have been enacted or substantively enacted by reporting date. Current tax for current and prior periods is recognised as a liability (or asset) to the extent that it is unpaid (or refundable). Where the Group qualifies for the research and development tax incentive refund (at 45%), this reduces the current tax expense recognised in profit and loss for the period. DEFERRED TAX Deferred tax is accounted for using the comprehensive balance sheet liability method in respect of temporary differences arising from differences between the carrying amount of assets and liabilities in the financial statements and the corresponding tax base of those items. In principle, deferred tax liabilities are recognised for all taxable temporary differences. Deferred tax assets are (l) Intangible assets 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. RESEARCH AND DEVELOPMENT COSTS Expenditure on research activities is recognised as an expense in the period in which it is incurred. Where no internally-generated intangible asset can be recognised, development expenditure is recognised as an expense in the period as incurred. An intangible asset arising from development (or from the development phase of an internal project) is recognised if, and only if, all of the following are demonstrated: t n e m e t a t S l i a c n a n F i e h t o t s e t o N 43 Annual Financial Report 2015 • • • • • • 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; operating leases. Operating lease payments are recognised as an expense on a straight-line basis over the lease term, except where another systematic basis is more representative of the time pattern in which economic benefits from the leased asset are consumed. how the intangible asset will generate probable future economic benefits; (o) Financial Liabilities 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 measure reliably the expenditure attributable to the intangible asset during its development. Internally-generated intangible assets in respect of development costs are stated at cost less accumulated amortisation and impairment, and are amortised on a straight-line basis over their estimated useful life of 5 years commencing from the date that revenue results. REGISTRATION COSTS Items of expenditure on registrations are capitalised to the extent that such costs can be measured reliably, future economic benefits are attributable to the expenditure, and it is probable that such future economic benefits will eventuate. Any capitalised registration costs are amortised over a period of 5-20 years in which the corresponding benefits are expected to arise, commencing from commercial sales to any of the countries for which the registration costs contributed to a successful registration. The unamortised balance of registration costs capitalised in previous periods is reviewed regularly at each reporting date, to ensure the criteria for deferral continue to be met. Where such costs are no longer recoverable, they are written off as an expense in the Consolidated Statement of Profit or Loss and Other Comprehensive Income. (m) 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, with the majority 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. (n) Leases Leases are classified as finance leases whenever the terms of the lease transfer substantially all the risks and rewards of ownership to the lessee. The company currently does not have any finance leases. All other leases are classified as 44 Trade payables and other accounts payable are classified as financial liabilities and are recognised when the company becomes obliged to make future payments resulting from the purchase of goods and services. Financial liabilities are initially measured at fair value, net of transaction costs. Financial liabilities are subsequently measured at amortised cost using the effective interest rate method, with interest expense recognised on an effective yield basis. The effective interest rate method is a method of calculating the amortised cost of a financial liability and of allocating interest expense over the relevant period. The effective interest rate is the rate that exactly discounts estimated future cash payments through the expected life of the financial liability, or where appropriate, a shorter period. (p) Plant and equipment Plant and equipment and leasehold improvements are stated at cost less accumulated depreciation and impairment. Cost includes expenditure that is directly attributable to the acquisition of the item. In the event that settlement of all or part of the purchase consideration is deferred, cost is determined by discounting the amounts payable in the future to their present value as at the date of the acquisition. Other than the charge over the groups assets held in relation to the bank bill loan, all other assets are not encumbered by any additional charge or mortgage. DEPRECIATION Depreciation is provided on plant and equipment and is calculated on a straight line basis so as to write off the cost of each asset over its expected useful life to its estimated residual value. Leasehold improvements are depreciated over the period of the lease or estimated useful life, whichever is the shorter, using the straight line method. The estimated useful lives, residual values and depreciation method are reviewed at the end of each annual reporting period. The following estimated useful lives are used in the calculation of depreciation: Leasehold improvements 5 years Plant and equipment 4-10 years (q) Provisions Provisions are recognised when the Group has a present Medical Developments International Limitedobligation, the future sacrifice of economic benefits is probable, and the amount of the provision can be measured reliably. The amount recognised as a provision is the best estimate of the consideration required to settle the present obligation at reporting date, taking into account the risks and uncertainties surrounding the obligation. Where a provision is measured using the cashflows estimated to settle the present obligation, its carrying amount is the present value of those cashflows. 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. DIVIDENDS A liability is recognised for dividends when they have been declared, determined or publicly recommended by the directors on or before the reporting date. (r) Revenue recognition SALE OF GOODS Revenue from the sale of goods is recognised when the company has transferred to the buyer the significant risks and rewards of ownership of the goods. INTEREST INCOME Interest income is recognised on a time proportionate basis that takes into account the effective yield on the financial asset. (s) Share based payments Equity-settled share-based payments granted are measured at fair value at the date of grant. Fair value is measured by use of a Monte Carlo valuation model. 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, based on the company’s estimate of options that will eventually vest. (t) Research and development recoveries R&D tax credits receivable as compensation for expenses or losses already incurred by the Company with no future related costs are recognised in profit or loss in the period in which they are quantified and become receivable. The company 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. (u) Application of new and revised Accounting Standards STANDARDS AND INTERPRETATIONS AFFECTING AMOUNTS REPORTED IN THE CURRENT PERIOD (AND/OR PRIOR PERIODS) The following new and revised Standards and Interpretations have been adopted in the current year and have affected the amounts reported and/or disclosures in these financial statements. STANDARDS AFFECTING PRESENTATION AND DISCLOSURE AASB 1031 ‘Materiality’, AASB 2013-9 ‘Amendments to Australian Accounting Standards’ – Conceptual Framework, Materiality and Financial Instruments’ (Part B: Materiality), AASB 2014-1 ‘Amendments to Australian Accounting Standards’ (Part C: Materiality) The revised AASB 1031 is an interim standard that cross-references to other Standards and the ‘Framework for the Preparation and Presentation of Financial Statements’ (issued December 2013) that contain guidance on materiality. The AASB is progressively removing references to AASB 1031 in all Standards and Interpretations. Once all of these references have been removed, AASB 1031 will be withdrawn. The adoption of AASB 1031, AASB 2013-9 (Part B) and AASB 2014-1 (Part C) does not have any material impact on the disclosures or the amounts recognised in the Group’s consolidated financial statements. AASB 2013-3 ‘Amendments to AASB 136 – Recoverable Amount Disclosures for Non-Financial Assets’ The amendments to AASB 136 remove the requirement to disclose the recoverable amount of a cash-generating unit (CGU) to which goodwill or other intangible assets with indefinite useful lives had been allocated when there has been no impairment or reversal of impairment of the related CGU. Furthermore, the amendments introduce additional disclosure requirements applicable to when the recoverable amount of an asset or a CGU is measured at fair value less costs of disposal. These new disclosures include the fair value hierarchy, key assumptions and valuation techniques used which are in line with the disclosure required by AASB 13 ‘Fair Value Measurements’. The application of these amendments does not have any material impact on the disclosures in the Group’s consolidated financial statements t n e m e t a t S l i a c n a n F i e h t o t s e t o N 45 Annual Financial Report 2015 Standards and Interpretations affecting the reported results or financial position There are no new and revised Standards and Interpretations adopted in these financial statements affecting the reporting results or financial position. STANDARDS AND INTERPRETATIONS IN ISSUE NOT YET ADOPTED At the date of authorisation of the financial statements, the Standards and Interpretations listed below were in issue but not yet effective. The Company does not expect that upon adoption that there will be any significant impact on the financial statements. STANDARDS/INTERPRETATIONS EFFECTIVE FOR ANNUAL REPORTING PERIODS BEGINNING ON OR AFTER EXPECTED TO BE INITIALLY APPLIED IN THE FINANCIAL YEAR ENDING AASB 9 ‘Financial Instruments’, and the relevant amending standards 1 January 2018 30 June 2019 AASB 15 ‘Revenue from Contracts with Customers’ and AASB 2014-5 ‘Amendments to Australian Accounting Standards arising from AASB 15’ AASB 2014-3 ‘Amendments to Australian Accounting Standards – Accounting for Acquisitions of Interests in Joint Operations’ AASB 2014-4 ‘Amendments to Australian Accounting Standards – Clarification of Acceptable Methods of Depreciation and Amortisation’ AASB 2014-4 ‘Amendments to Australian Accounting Standards – Clarification of Acceptable Methods of Depreciation and Amortisation AASB 2015-1 ‘Amendments to Australian Accounting Standards – Annual Improvements to Australian Accounting Standards 2012-2014 Cycle’ AASB 2015-2 ‘Amendments to Australian Accounting Standards – Disclosure Initiative: Amendments to AASB 101’ AASB 2015-3 ‘Amendments to Australian Accounting Standards arising from the Withdrawal of AASB 1031 Materiality’ 1 January 2017 30 June 2018 1 January 2016 30 June 2017 1 January 2016 30 June 2017 1 January 2016 30 June 2017 1 January 2016 30 June 2017 1 January 2016 30 June 2017 1 July 2015 30 June 2016 46 Medical Developments International Limited2. Critical accounting judgements and key sources of estimation uncertainty The following are the key assumptions concerning the future, and other key sources of estimation uncertainty at the balance sheet date, that have significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year: IMPAIRMENT OF GOODWILL Determining whether goodwill is impaired requires an estimation of the value in use of the cash-generating units to which goodwill has been allocated. The value in use 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. The carrying amount of goodwill at the balance sheet date was $7,368K (2014: $7,368K). Details of the impairment calculation are provided in Note 13. AMORTISATION OF CAPITALISED REGISTRATION COSTS During the year, management reviewed the unamortised balance of registration costs capitalised in previous periods. Consideration was given to the cost for each classification of capitalised costs to determine whether the corresponding benefits are likely to arise. Developments continue on the unamortised categories of registration costs capitalised in prior periods, and once revenue has been generated in these categories, the balances will be amortised. At the reporting date there was no indication that any of the internally generated intangible assets, relating to registration costs, were impaired. Management continually reassess the appropriateness of useful lives assigned to each individual category of registration costs. This situation will be closely monitored, and amortisation will be recognised in future periods as corresponding economic benefits flow. Details of the capitalised registration costs are provided in Note 14. GOING CONCERN The FY15 Financial statements have been prepared on a going concern basis. The going concern assumption continues to apply to Medical Developments International Ltd as at 30 June 2015 as the Group continues to be profitable, generates positive operating cash flows, has significantly reduced its external loan facility balance and continues to be in a positive net asset position, which enables the Group to meets its debts and obligations as and when they fall due. 3. Segment information PRODUCTS AND SERVICES WITHIN EACH BUSINESS SEGMENT For management purposes, the company is organised into three business units – Pharmaceuticals, Medical Devices and Veterinary products. These units are the basis on which the company reports its primary segment information. The principal products and services of each of these divisions are as follows: • Pharmaceuticals – the sale of Penthrox® primarily within Australia and New Zealand and with some sales in Eastern Europe, the Middle East, and South America. • Medical Devices – the sale of medical devices, particularly the Space Chamber and Breath-Alert Peak- Flow meters, primarily within Australia and New Zealand, but with some sales in Asia, Europe, the Middle East and North America. • Veterinary Products – the sale of veterinary products within Australia, Europe, and the United States. No operating segments have been aggregated in arriving at the reportable segments of the group. There have also been no sales between reportable segments. The accounting policies of the reportable segments are the same as the Group’s accounting policies described in Note 1. This is the measure reported to the chief operating decision maker for the purposes of resource allocation and assessment of segment performance. Liabilities are not disclosed per segment as it is not possible to track these on a segment basis. t n e m e t a t S l i a c n a n F i e h t o t s e t o N 47 Annual Financial Report 2015 SEGMENT REVENUES AND RESULTS PHARMACEUTICALS MEDICAL EQUIPMENT VETERINARY EQUIPMENT UNALLOCATED TOTAL 2015 $’000 2014 2015 2014 2015 2014 2015 2014 2015 2014 $’000 $’000 $’000 $’000 $’000 $’000 $’000 $’000 $’000 7,092 5,377 4,078 3,503 - - - - 438 - 490 - - 111 - 11,608 9,370 25 111 25 11,719 9,395 3,456 2,389 270 53 281 131 4,007 2,573 (1,377) (1,480) (1,377) (1,480) 3,456 2,389 270 53 281 131 (1,377) (1,480) 2,630 1,093 (235) (207) (44) (19) (6) (3) (93) (89) (378) (318) 3,221 2,182 226 34 275 128 (1,470) (1,569) 2,252 775 (76) (134) (76) (1,546) (1,703) 2,176 (134) 641 (647) 234 (647) 234 (2,193) (1,469) 1,529 875 15,504 13,982 5,162 5,049 - - - - 859 - 852 1,463 2,677 22,988 22,560 - 5,581 6,736 5,581 6,736 1,279 1,460 193 194 14 6 23 215 1,509 1,875 Revenues: External sales Other income (excluding interest) Total revenue Results: Segment results Unallocated Profit before interest, income tax depreciation & amortisation Depreciation & Amortisation Profit before interest and tax Net Interest Profit before income tax expense Income tax benefit/(expense) Net profit for the period from continuing operations Assets and Liabilities: Assets Liabilities Other Segment Information: Acquisition of segment assets 48 Medical Developments International Limited REVENUE FROM MAJOR PRODUCTS AND SERVICES Revenue from major products and services has not been presented as it is not considered practicable to do so. GEOGRAPHICAL INFORMATION The Group operates in three principal geographical areas: Australia (country of domicile); New Zealand; and “International” comprising Eastern Europe, Germany, Canada, Middle East and South America. The Group’s revenue from continuing operations from external customers and information about its non-current assets by location of assets are detailed below: GEOGRAPHICAL INFORMATION Australia New Zealand International REVENUE FROM EXTERNAL CUSTOMERS REVENUE FROM EXTERNAL CUSTOMERS 2015 $’000 7,586 1,394 2,628 11,608 % 65.4 12.0 22.6 100.0 2014 $’000 6,659 1,372 1,339 9,370 The Group’s non-current assets by location at 30 June 2015 are detailed below: NON-CURRENT SEGMENT ASSETS Leasehold improvements at cost Plant and equipment at cost Goodwill at gross carrying amount Other intangible assets at cost Deferred tax asset AUSTRALIA $’000 250 1,023 7,368 9,113 - 17,754 OVERSEAS $’000 - 249 - 7 143 399 % 71.1 14.6 14.3 100.0 TOTAL $’000 250 1,272 7,368 9,120 143 18,153 Information about major customers The Group’s two largest customers who contributed to the Group’s revenue from external sales for both 2015 and 2014 are below. No other single customer contributed 10% or more to the Group’s revenue for both 2015 and 2014. TOP CUSTOMERS WITH > 10% SALES Customer A Customer B 2015 $’000 1,070 1,019 2,089 % TOTAL SALES 9.2 8.8 2014 $’000 1,035 1,004 2,039 % TOTAL SALES SEGMENT 11.0 10.7 Pharmaceutical/Medical Equipment Pharmaceutical/Medical Equipment t n e m e t a t S l i a c n a n F i e h t o t s e t o N 49 Annual Financial Report 2015 4. Items included in profit and loss (a) Revenue and other income Revenue from sale of goods Interest revenue - bank deposits Other Income Government grant income (b) Expense items included in profit and loss Profit before income tax has been arrived at after charging the following expenses: Depreciation of non-current assets Amortisation of non-current assets Research & development costs immediately expensed Operating lease rental expenses - minimum lease payments Gain/(loss) on foreign currency transactions Finance Expenses Interest on bank loans Interest on other loans/hire purchase arrangements 2015 $'000 2014 $'000 11,608 9,370 5 - 111 11,724 (233) (144) (129) (167) 32 (58) (23) (81) 22 25 - 9,417 (223) (95) (51) (155) (51) (125) (31) (156) Employee benefit expense: Short-term employee benefits Superannuation contributions (2,624) (344) (2,362) (305) 50 Medical Developments International Limited5. Income Taxes (a) Income tax recognised in profit or loss Tax expense comprises: Current tax expense Adjustments recognised in the current year in relation to the current tax of prior year Deferred tax expense in relation to the deferred tax of prior year Deferred tax expense relating to the origination and reversal of temporary differences Total tax expense/(benefit) The prima facie income tax expense on pre-tax accounting profit reconciles to the income tax Profit from operations Income tax calculated at 30% Research and development expense Effect of expenses that are not deductible in determining taxable profit Adjustments recognised in the current year in relation to the current tax of prior year Deferred tax expense in relation to the deferred tax of prior year Income tax expense recognised in the Statement of Profit or Loss and Other Comprehensive Income 2015 $'000 659 41 - (53) 647 2,176 653 (53) 6 41 - 647 2014 $'000 (375) (334) 10 465 (234) 641 192 (107) 5 (334) 10 (234) The tax rate used in the above reconciliation is the corporate tax rate of 30% payable by Australian corporate entities on taxable profits under Australian tax law. There has been no change in the corporate tax rate when compared with the previous reporting period. (b) Income tax recognised directly in equity No current and deferred tax amounts have been charged directly to equity during the period (2014: $nil) (c) Current tax assets Income tax receivable (payable)/receivable (d) Deferred tax asset (non-current) Tax losses (e) Deferred tax liabilities Temporary differences (294) 143 512 104 (1,703) (1,414) t n e m e t a t S l i a c n a n F i e h t o t s e t o N 51 Annual Financial Report 2015 2015 Deferred tax assets/(liabilities): Accrued expenses* Deferred grant revenue Other assets Other intangibles Property, Plant & Equipment Provisions Tax losses Unrealised foreign exchange losses OPENING BALANCE CHARGED TO INCOME CLOSING BALANCE $’000 $’000 $’000 51 95 (2) (1,678) 20 95 104 5 (1,309) 141 - - (349) (8) 47 (104) 23 (250) 192 95 (2) (2,027) 12 142 0 28 (1,560) * - $143,000 relates to a deferred tax asset relating to the operations of the UK entity (a foreign tax jurisdiction). This component of the deferred tax asset has therefore been separately disclosed within the statement of financial position. 2014 Deferred tax assets/(liabilities): Accrued expenses Deferred grant revenue Other assets Other intangibles Property, Plant & Equipment Provisions Tax losses Unrealised foreign exchange losses OPENING BALANCE CHARGED TO INCOME CLOSING BALANCE $’000 $’000 $’000 21 95 (3) (1,173) 23 120 61 21 (835) 30 - 1 (505) (3) (25) 43 (16) (475) 51 95 (2) (1,678) 20 95 104 5 (1,310) 52 Medical Developments International Limited6. Key management personnel compensation The aggregate compensation of the key management personnel of the company and the Group is set out below: Short-term employee benefits Post employment benefits Long-term employee benefits Share based payments Termination benefits 2015 $’000 625 64 8 - - 697 2014 $’000 642 58 6 - 10 716 7. Remuneration of auditors Auditor of the parent entity Audit or review of the financial report Taxation services Other services 2015 $ 2014 $ 79,000 74,100 18,800 30,000 17,500 - 127,800 91,600 t n e m e t a t S l i a c n a n F i e h t o t s e t o N at the end of the year, $236,222 (2014: $640,615) is due from the Group’s two largest customers (Refer to Note 3). Included in the trade receivable balance are debtors with a carrying amount of $91,046 (2014: $135,616) which are past due at the reporting date for which the Group has not provided as there has not been a significant change in credit quality and the amounts are still considered recoverable. The Group does not hold any collateral over these balances. AGEING OF PAST DUE BUT NOT IMPAIRED 60 - 90 days > 90 days Total 2015 $’000 9 82 91 2014 $’000 22 114 136 In determining the recoverability of trade receivables, the Group considers any change in the credit quality of the trade receivable from the date the credit was initially granted up to the reporting date. The concentration of credit risk is limited due to the fact that the customer base is large and unrelated. The directors believe that there is no further credit provision required in excess of the allowance for doubtful debts. 9. Current inventories 2015 $’000 2014 $’000 709 334 858 (14) 623 194 647 (18) 1,887 1,446 The auditor of the entity is Deloitte Touche Tohmatsu. The other services relate to accounting advice and additional assurance services relating to government grant applications. 8. Current receivables Raw materials: At cost Work in progress: At cost Finished goods: At cost Provisions for obsolesence Trade receivables Allowance for doubtful debts GST recoverable 2015 $’000 1,777 - 42 2014 $’000 1,770 - 38 1,819 1,808 The provision for obsolescence at 30 June 2015 represents predominately obsolete packing materials. 10. Other current assets 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 credit policy in place to reduce its credit risks to significant debtors. Of the trade receivables balance Prepayments Other receivables 2015 $’000 175 - 175 2014 $’000 138 15 153 53 Annual Financial Report 2015 11. Subsidiaries Details of the Group’s subsidiaries at the end of the reporting period are as follows. NAME OF SUBSIDIARY PRINCIPLE ACTIVITY Medical Developments UK Limited Distribution of pharmaceutical drug and medical and veterinary equipment PLACE OF INCORPORATION AND OPERATION United Kingdom PROPORTION OF OWNERSHIP INTEREST AND VOTING POWER HELD BY THE GROUP 30/06/15 100% 30/06/14 100% 12. Property, Plant & Equipment LEASEHOLD IMPROVEMENTS AT COST PLANT AND EQUIPMENT AT COST TOTAL $’000 $’000 $’000 515 76 (36) 555 64 - 619 (218) (71) 1 (288) (80) - (368) 267 251 2,600 247 23 2,870 489 78 3,437 (1,871) (152) 11 (2,012) (154) - (2,166) 858 1,271 3,115 323 (13) 3,425 553 78 4,056 (2,089) (223) 12 (2,300) (234) - (2,534) 1,125 1,522 Gross carrying amount Balance at 1 July 2013 Additions Disposals Balance at 30 June 2014 Additions Transfers Balance at 30 June 2015 Accumulated depreciation Balance at 30 June 2013 Depreciation expense Disposals Balance at 30 June 2014 Depreciation expense Disposals Balance at 30 June 2015 Net book value As at 30 June 2014 As at 30 June 2015 54 Medical Developments International Limited 13. Goodwill Gross carrying amount Balance at beginning of financial year 2015 $’000 2014 $’000 The recoverable amount of all three cash-generating units is based on a value in use calculation for each unit which uses cash flow projections based on a five-year projection period and terminal value. The Board of Directors approved financial budget for the following year is used to determine the cash flows for year 1. 7,368 7,368 Recoverable amount testing has been based on EBITDA growth rates for years 2-5 of: Balance at end of financial year 7,368 7,368 Pharmaceuticals: 12.5% based on expansion into new markets Net book value Balance at beginning of financial year 7,368 7,368 Medical Devices: 15% based on expansion into new markets Balance at end of financial year 7,368 7,368 Veterinary equipment: 10% based on expansion into new markets During the year, the company assessed the recoverable amount of goodwill and determined that there was no impairment (2014: $nil). ALLOCATION OF GOODWILL TO CASH- GENERATING UNITS Goodwill has been allocated for impairment testing purposes to three individual cash-generating units: pharmaceutical business, medical devices business and veterinary equipment business. The carrying amount of goodwill allocated to cash-generating units is as follows: Pharmaceuticals Medical devices Veterinary equipment 2015 $’000 3,808 2,979 581 7,368 2014 $’000 3,808 2,979 581 7,368 A terminal value after 5 years based on a long term growth rate of 2.5%, and a pre-tax discount rate of 14.06% per annum (2014: 15.09% per annum) have been used to calculate the carrying value of the intangible assets. The key assumptions used in the value in use calculations for all units are: • EBITDA growth – described above; and • Gross margin – it is assumed that gross margin of the Pharmaceutical & Medical Devices segments will continue to improve following investment and activities aimed at improvement in the manufacturing process and procedures. Management believes that any reasonably possible change in the key assumptions on which the recoverable amount for each of the three units is based would not cause the carrying amounts to exceed their recoverable amounts. t n e m e t a t S l i a c n a n F i e h t o t s e t o N 55 Annual Financial Report 2015 14. Other intangible assets 2015 DEVELOPMENT PATENTS & TRADEMARKS CAPITALISED REGISTRATION COSTS OTHER TOTAL $’000 $’000 $’000 $’000 $’000 Gross carrying amount Balance at 1 July 2013 Additions Disposals Balance at 30 June 2014 Additions Transfer Balance at 30 June 2015 Accumulated amortisation Balance at 1 July 2013 Amortisation expense Balance at 30 June 2014 Amortisation expense Balance at 30 June 2015 Net book value As at 30 June 2014 As at 30 June 2015 898 640 - 1,538 132 (77) 1,593 - (48) (48) (71) (119) 1,490 1,474 365 36 (18) 383 65 - 448 (104) (32) (136) (41) (177) 247 271 6,070 876 - 6,946 696 - 7,642 (287) (11) (298) (32) (330) 6,648 7,312 - - - - 63 - 63 - - - - - - 63 7,333 1,552 (18) 8,867 956 (77) 9,746 (391) (91) (483) (144) (626) 8,385 9,120 The amortisation charge for the year of $111,000 (2014: $95,000) has been included in administration expenses. For an explanation of amortisation periods refer Note 1(l). 15. Current trade and other payables Trade payables (i) Accrued expenses Employee benefits payable PAYG witholding tax payable 2015 $’000 810 387 32 2 2014 $’000 746 316 28 2 1,231 1,092 56 (i) The average credit period on purchase of goods is 30 days. No interest is charged on trade payables. The company has financial risk management policies in place to ensure that all payables are paid within the credit time frame. Medical Developments International Limited anniversary of the completion of stages 1a and 2 and is then calculated at the Westpac Bank Lending Rate at the date the relevant note was issued, plus 2%. The funding for stage 2 is interest free. (v) The Group has an overdraft facility of $200,000. As at 30 June 2015, this remains unused. 17. Current provisions 2015 $’000 215 2014 $’000 180 Employee benefits 18. Non-current provisions Employee benefits 2015 $’000 93 2014 $’000 70 The company has 29.5 full time equivalent employees at 30 June 2015 (2014: 26.0) 19. Other non-current liabilities Revenue received in advance Unearned government grant income 2015 $’000 616 318 934 2014 $’000 - 318 318 Unearned government grant income represents funds received through the Commercial Ready Programme from the Federal Government. 16. Borrowings Secured - at amortised cost Hire Purchase (i) Hire Purchase (ii) Bank Bill (iii) Other (iv) Current Non-current 2015 $’000 115 52 538 406 1,111 92 1,019 1,111 2014 $’000 147 66 3,000 449 3,662 3,089 573 3,662 SUMMARY OF BORROWING ARRANGEMENTS (i) On 1 March 2013 the Group entered into a commercial loan agreement to fund the purchase of a new bottling station. During the current year the commercial loan agreement was converted into a Hire Purchase Agreement. The current weighted-average effective interest rate on the loan is 6.76% p.a. The agreement is secured by a registered charge over the equipment financed. (ii) On 4 September 2013 the Group entered into a Hire Purchase Agreement in relation to plant and equipment. The term is 5 years and the current weighted average effective interest rate on the loan is 6.54%. The agreement is secured by a registered charge over the equipment financed. (iii) The Bank Bill Facility with a variable interest rate and 90 day roll over period was renegotiated during the year. As at 30 June 2015, $538,000 has been drawn upon and $3,262,000 remains unused. The current weighted average effective interest rate on the bills is 4.34% p.a. The Bank Bill is secured by a registered charge over all of the Group’s assets. (iv) On 29 June 2012, the group entered into an agreement with the Commonwealth Scientific and Industrial Research Organisation (“CSIRO”) to fund the development of a new production process for the pain relieving ingredient used in Penthrox®. Funding is receivable at the commencement of each of three stages of development and is payable over a three year term upon the completion of the relevant stage. As at 30 June 2015, the stage 1a and 1b are complete. Should MVP default on the loan, CSIRO has the option to convert the debt into shares in MVP at fair market value. This funding is interest-free until the first t n e m e t a t S l i a c n a n F i e h t o t s e t o N 57 Annual Financial Report 2015 20. Issued Capital 2015 No. 2015 $’000 2014 No. 2014 $’000 Fully paid ordinary shares Balance at beginning of financial year 57,725,143 10,946 57,420,703 10,559 Shares Issued - Dividends Reinvestment Plan 304,440 387 Balance at end of financial year 57,725,143 10,946 57,725,143 10,946 Fully paid ordinary shares carry one vote per share and carry the right to dividends. 21. Reserves 22. Retained earnings 2015 $’000 2014 $’000 (a) Foreign currency translation reserve Balance at beginning of financial year Balance at beginning of year Exchange differences arising on translating the foreign operations (33) 54 (13) (20) Dividends paid Dividends Reinvested Net profit attributable to members Balance at end of financial year Balance at end of year 21 (33) 2015 $’000 4,911 - - 1,529 6,440 2014 $’000 5,183 (760) (387) 875 4,911 Exchange differences relating to the translation of the results and net assets of the Group’s foreign operations from their functional currencies to the Group’s presentation currency (i.e. Australian dollars) are recognised directly in other comprehensive income and accumulated in the foreign currency translation reserve. Gains and losses on hedging instruments that are designated as hedging instruments for hedges of net investments in foreign operations are included in the foreign currency translation reserve. Exchange differences previously accumulated in the foreign currency translation reserve (in respect of translating both the net assets of foreign operations and hedges of foreign operations) are reclassified to profit or loss on the disposal of the foreign operation. 23. Earnings per share 2015 CENTS PER SHARE 2014 CENTS PER SHARE Basic earnings per share Diluted earnings per share 2.6 2.6 1.5 1.5 BASIC EARNINGS PER SHARE The earnings and weighted average number of ordinary shares used in the calculation of basic earnings per share are as follows: Earnings 2015 $’000 1,529 2015 No. 2014 $’000 875 2014 No. Weighted average number of ordinary shares 57,725,143 57,639,233 DILUTED EARNINGS PER SHARE There is no difference from basic EPS in the calculation of diluted EPS. 58 Medical Developments International Limited 24. Dividends There were no dividends declared for the full years ended 30 June 2015 and 30 June 2014. A dividend of 2 cents per share was declared in respect of the financial year ended 30 June 2013. The resulting dividend was paid in the financial year ended 30 June 2014 with the company paying dividends of $760,000 and the balance of $387,000 issued as shares under the Dividend Reinvestment Plan. t n e m e t a t S l Recognised amounts Fully paid ordinary shares Final dividend franked to 30% Interim dividend franked to 30% Unrecognised amounts Fully paid ordinary shares Final dividend franked to 30% 2015 2014 CENTS PER SHARE $’000 CENTS PER SHARE $’000 i a c n a n F i - - - - 2.0 - 2.0 2.0 - - - - - e h t o t s e t o N 1,148 - 1,148 1,148 1,148 Adjusted franking account balance 2015 $’000 106 2014 $’000 529 26. Commitments for expenditure (a) Capital expenditure commitments 25. Operating leases There were no capital expenditure commitments at 30 June 2015. Operating leases primarily relate to factory leases with remaining lease terms of up to 5 months and further 3 year options attached to each of these leases. The company does not have the option to purchase the leased asset at the expiry of the lease period. 27. Related party disclosures Non cancellable operating lease payments: Not longer than 1 year Longer than 1 year and not longer than 5 years 2015 $’000 2014 $’000 There were no related party transactions during the 2015 or 2014 financial years. 28. Subsequent events 82 13 95 186 99 285 There has not been any matter or circumstance that has arisen that has significantly affected, or may significantly affect the operations of the company, the results of those operations, or the state of affairs of the company in future years. 59 Annual Financial Report 2015 29. Notes to the Consolidated Statement of Cash Flows 2015 $’000 2014 $’000 954 954 1,529 (5) 377 (32) - 79 806 250 (11) (441) (22) 155 35 616 23 1,659 1,659 875 (22) 318 (18) 14 - (215) 518 534 (89) (35) (572) (21) - 9 3,359 1,295 200 200 538 3,262 3,800 200 200 3,000 950 3,950 (a) Reconciliation of cash and cash equivalents For the purposes of the Consolidated Statement of Cash Flows, cash includes cash on hand and in banks. Cash at the end of the financial year as shown in the Consolidated Statement of Cash Flows is reconciled to the related item in the Statement of Financial Position as follows: Cash and cash equivalents (b) Reconciliation of profit for the period to net cash flows from operating activities Profit for the period Interest received Depreciation and amortisation of non-current assets Net foreign exchange (gain) Loss on disposal of property, plant and equipment Impairment loss on trade receivables Increase in tax payable Increase in deferred tax liability Movements in working capital Decrease/(Increase) in assets: Current receivables Current inventories Other current assets Increase/(decrease) in liabilities: Current payables Current provisions Other liabilities Non-current provisions Net cash from operating activities (c) Financing facilities Unsecured bank overdraft facility, reviewed annually and payable at call: Amount unused Bank bill facility with a 90 day roll over period: Amount used Amount unused Details of further financing facilities are disclosed in Note 16 (d) Non-cash transactions There was no dividend paid during the current year therefore no Dividend Reinvestment Plan arose. The total amount of dividend re-invested in 2014 was $387,000. 60 Medical Developments International Limited 30. Financial Instruments (b) Significant accounting policies (a) Capital risk management The Group manages its capital 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 or trade financial instruments, including derivatives, for speculative purposes. The capital structure of the Group consists of net debt (borrowings as detailed in note 16) and equity of the Group (comprising issued capital, reserves, retained earnings, and cash and cash equivalents as detailed in notes 20, 21, 22, and 29(a), respectively). The Group’s Audit and Risk Committee reviews the capital structure of the Group on a semi-annual basis. As part of this review, the committee considers the cost of capital and the risks associated with each class of capital. The gearing ratio at 30 June 2015 is 1% (see below). Details of significant accounting policies and methods adopted, including the criteria for recognition, the basis of measurement and the basis on which revenues and expenses are recognised, in respect of each class of financial asset, financial liability and equity instrument are disclosed in note 1 to the financial statements. These policies were consistent throughout the current year and the prior year. (c) Financial risk management objectives The Group’s finance function provides services to the business, co-ordinates access to domestic and international financial markets, monitors and manages financial risks relating to the operations of the Group. These risks include market risk (including currency risk, fair value interest rate risk and price risk), credit risk, liquidity risk and cash flow interest rate risk. (d) Credit risk management Debt (i) Cash and bank balances Net debt/(cash) 2015 $’000 1,111 (954) 157 2014 $’000 3,662 (1,659) 2,003 Credit risk refers to the risk that a counter party will default on its contractual obligations resulting in financial loss to the Group. The Group has adopted a policy of only dealing with creditworthy counterparties. The Group’s exposure is continually monitored and the aggregate value of transactions concluded is spread amongst approved counterparties. Equity (ii) 17,407 15,824 Net debt to equity ratio 1% 13% (i) Debt is defined as long-term and short-term borrowings as described in note 16. (ii) Equity includes all capital and reserves of the group that are managed as capital. The bank bill facility includes financial covenants whereby the current ration must be no less than 2 times, a debt cover ratio that must be no less than 2 times and the operating leverage ratio must be no higher than 3 times. Monitoring of said covenants is performed monthly by management and signed off quarterly by management. There have been no breaches in the current year and there are no forecasted breaches for forthcoming periods. Trade receivables consist of a large number of customers. Ongoing credit evaluation is performed on the financial condition of these accounts receivable and advance payments are requested where deemed appropriate. The carrying amount of financial assets recorded in the financial statements, net of any allowance for losses, represents the Group’s maximum exposure to credit risk without taking account of the value of any collateral or other security obtained. Apart from the two largest customers of the Group (refer to Notes 3 and 8), the Group does not have significant credit risk exposure to any single counterparty or any group of counterparties having similar characteristics. The Group defines counterparties as having similar characteristics if they are related entities. Concentration of credit risk to any other counterparty did not exceed 5% of gross monetary assets at any time during the year. t n e m e t a t S l i a c n a n F i e h t o t s e t o N 61 Annual Financial Report 2015 (e) Foreign currency risk management The Group undertakes certain transactions denominated in foreign currencies, hence exposures to exchange rate fluctuations arise. The carrying amount of the Group’s foreign currency denominated monetary assets and monetary liabilities at the reporting date is as follows: only outstanding foreign currency denominated monetary items and adjusts their translation at the period end for a 10% change in foreign currency rates. A positive number indicates an increase in profit or loss where the Australian Dollar strengthens against the respective currency. For a weakening of the Australian Dollar against the respective currency there would be an equal and opposite impact on the profit. LIABILITIES ASSETS 2015 $’000 404 257 - - 4 2014 $’000 350 35 - - - USD GBP NZD EUR CND 2015 $’000 2014 $’000 370 Profit or Loss 755 131 28 32 4 - 95 - - 665 385 950 465 Amounts of exposure are not currently significant and as such forward contracts and currency swap agreements are not used. FOREIGN CURRENCY SENSITIVITY ANALYSIS The Group predominantly trades in Australian dollars (AUD), but has limited exposure to the US dollar (USD) based on a portion of its overseas sales and purchases. The following table details the Group’s sensitivity to a 10% increase and decrease in the Australian Dollar against the USD. 10% is the sensitivity rate used when assessing foreign currency risk internally by key management and represents management’s assessment of the possible change in foreign currency rates. The sensitivity analysis includes USD IMPACT 2015 $’000 (35) 2014 $’000 (2) This is attributable to the exposure outstanding on USD receivables and payables at year end in the Group. The exposure to movement in NZD, EUR, GBP and CAD is not deemed to be significant. (f) Fair value of financial instruments The Directors consider that the carrying amount of financial assets and liabilities recorded at amortised cost in the financial statements approximates their respective net fair values, determined in accordance with the accounting policies disclosed in note 1 to the financial statements. The Group does not recognise any financial instruments that are measured subsequent to initial recognition at fair value. (g) Interest rate risk management The Group is exposed to interest rate risk as it holds cash at floating interest rates. The following table details the Group’s exposure to interest rate risk as at 30 June 2015 and 30 June 2014. 2015 AVERAGE INTEREST RATE LESS THAN 1 YEAR 1 TO 5 YEARS MORE THAN 5 YEARS NON- INTEREST BEARING TOTAL % $’000 $’000 $’000 $’000 $’000 VARIABLE INTEREST RATE MATURITY Financial assets Cash Receivables Financial liabilities Payables Borrowings 62 0.06 - - 4.92 954 - 954 - 92 92 - - - - 1,019 1,019 - - - - - - - 1,819 1,819 1,231 - 1,231 954 1,819 2,773 1,231 1,111 2,342 Medical Developments International Limited 2014 AVERAGE INTEREST RATE LESS THAN 1 YEAR 1 TO 5 YEARS MORE THAN 5 YEARS NON- INTEREST BEARING TOTAL VARIABLE INTEREST RATE MATURITY % $’000 $’000 $’000 $’000 $’000 Financial assets Cash Receivables Financial liabilities Payables Borrowings 1.29 - - 5.28 1,659 - 1,659 - 3,089 3,089 - - - - 573 573 - - - - - - 1,808 1,808 1,092 - 1,092 1,659 1,808 3,467 1,092 3,662 4,754 The following table details the Group’s sensitivity to a 50 basis point increase or decrease in interest rates. Interest rate risk table Profit or Loss 2015 $’000 (1) 2014 $’000 (10) (h) Liquidity risk management The Group manages liquidity risk by maintaining adequate cash reserves, banking facilities and reserve borrowing facilities by continuously monitoring forecast and actual cash flows and matching the maturity profiles of financial assets and liabilities. LIQUIDITY RISK TABLE The following table details the Group’s remaining contractual maturity for its non-derivative financial liabilities. The table has been drawn up based on the undiscounted cash flows of financial liabilities based on the earliest date on which the Group can be required to pay. The table includes the principal cash flows. 2015 Payables Borrowings 2014 Payables Borrowings LESS THAN 1 YEAR 1 TO 5 YEARS MORE THAN 5 YEARS TOTAL WEIGHTED AVERAGE EFFECTIVE INTEREST RATE % $’000 $’000 $’000 $’000 - 4.92 - 5.28 1,231 92 1,323 1,092 3,089 4,181 - 1,019 1,019 - 573 573 - - - - - - 1,231 1,111 2,342 1,092 3,662 4,754 t n e m e t a t S l i a c n a n F i e h t o t s e t o N 63 Annual Financial Report 2015 31. Parent Entity Information The accounting policies of the parent entity, which have been applied in determining the financial information shown below, are the same as those applied in the consolidated financial statements. Refer to note 1 for a summary of the significant accounting policies relating to the Group. Financial Position Assets Current Assets Non-Current Assets Total Assets Liabilities Current Liabilities Non-Current Liabilities Total Liabilities Equity Issued Capital Reserves Retained Earnings Total Equity Financial Performance Profit for the year Other comprehensive income Total comprehensive income 30 JUNE 2015 $’000 4,631 18,003 22,634 1,678 3,151 4,829 10,946 - 6,859 17,805 2015 $’000 1,564 - 1,564 30 JUNE 2014 $’000 6,057 16,871 22,928 4,288 2,399 6,687 10,946 - 5,295 16,241 2014 $’000 999 - 999 The commitments of the parent are the same as those of the overall consolidated group. 64 Medical Developments International Limited Additional Stock Exchange Information as at 31 August 2015 NUMBER OF HOLDERS OF EQUITY SECURITIES Distribution of holders of equity securities fully paid ordinary shares Ordinary share capital 57,725,143 fully paid ordinary shares held by 1393 individual shareholders. All issued ordinary shares carry one vote per share. 1 – 1,000 1,001 – 5,000 5,001 – 10,000 10,001 – 100,000 100,001 and over Holding less than a marketable parcel 280 485 226 347 55 1,393 54 SUBSTANTIAL SHAREHOLDERS MR DAVID JOHN WILLIAMS TWENTY LARGEST HOLDERS OF EQUITY SECURITIES MR DAVID JOHN WILLIAMS HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED RBC INVESTOR SERVICES AUSTRALIA NOMINEES P/L DR RUSSELL KAY HANCOCK HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED - A/C 2 KIDDER PEABODY PTY LTD J P MORGAN NOMINEES AUSTRALIA LIMITED LUJETA PTY LTD CITICORP NOMINEES PTY LIMITED MRS ERICA MARGARET STRONG MR ALISTAIR DAVID STRONG MR RAYMOND WILLIAM WALTER + MR ALEXANDER SCOTT HAGAN MULLACAM PTY LTD IMAJ PTY LTD MR MICHAEL GERARD SUGERMAN BRISPOT NOMINEES PTY LTD PNSF PTY LTD AMP LIFE LIMITED LONCETA PTY LTD UBS NOMINEES PTY LTD NUMBER % 23,371,990 40.49 NUMBER % 23,371,990 40.49 3,370,766 1,805,957 1,500,727 1,169,015 1,136,867 1,053,115 1,000,000 927,434 580,000 470,000 452,185 426,710 400,000 375,550 356,487 352,074 341,755 313,410 305,572 5.84 3.13 2.60 2.03 1.97 1.82 1.73 1.61 1.00 0.81 0.78 0.74 0.69 0.65 0.62 0.61 0.59 0.54 0.53 65 Annual Financial Report 201532. Additional company information Medical Developments International Limited is a listed public company, incorporated and operating in Australia. COMPANY SECRETARY Mr. Mark Edwards REGISTERED OFFICE AND PRINCIPAL PLACE OF BUSINESS 7/56 Smith Road Springvale VIC 3171 Tel: (03) 9547 1888 SHARE REGISTRY Computershare Investor Services Pty Ltd Yarra Falls 452 Johnston Street Abbotsford VIC 3067 Tel: 1300 850 505 66 Medical Developments International Limited

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