Final Results

Aortech International PLC 06 September 2007 6 September 2007 AorTech International plc Results for the year ended 31 March 2007 AorTech International plc (AIM: AOR) ('AorTech' or the 'Company'), the biomaterials and medical device development company, today announces its results for the year ended 31 March 2007. Operational Highlights • Partnership with St Jude Medical for cardiac pacing leads continuing well, with expansion of manufacturing capacity of Elast-Eon extrusions and mouldings in response to customer demand; • FDA approved human use of its polymer technology Elast-Eon; • Customer evaluations underway in the areas of cardiac surgery, cardiology, orthopaedics and urology: - October 2006 - non-exclusive licence and material supply agreement signed with Allium Medical Inc in the field of non-vascular stents; - December 2006 - Exclusive material licensing and supply agreement with Avalon Laboratories, leading supplier of cardiopulmonary vascular cannulae; - December 2006 - Exclusive material licensing agreement signed with Harland Medical Systems, LLC in the field of short-term guide wire and catheter coating applications - April 2007 - Supply and licence agreement with Cardiosolutions, Inc., for the purchase and use of Elast-EonTM in the field of mitral valve repair • Conditional re-approval of gel-filled breast implants by FDA and three patents filed for AorTech breast implant technology; • Successful presentation of the polymer heart valve at the eminent TCT symposium in October 2006; • Creation of a Medical Advisory Board - appointment of esteemed plastic surgeons, V. Leroy Young, M.D., and Mark L Jewell; • Post period-end - entered a licensing and supply agreement with a global medical device company with a potential income value of up to c.US$32m for the evaluation of Elast-EonTM along with royalty payments; Financial Highlights • Group turnover £0.3m (2005/6 £1.4m inclusive of a £1.1m upfront payment from St Jude Medical); • Loss after tax £2.1m (2005/6 £0.5m loss) • At 31 March 2007, cash reserves of £1.5m (2006: £2.7m) • Post period end placing raised £5.1 million (before expenses), to fund further development plans. Jon Pither, Chairman, said: 'We have made significant progress during the past two years culminating in the post balance sheet agreement with a global medical device company. During this time, we have achieved multinational regulatory approvals, a reputation for quality and service, thousands of human implants of our premier biostable polymer Elast-EonTM, and significantly increased operational capacity. 'The Placing will provide us with the necessary resource to carry through our development plans, as we seek to deploy our proven technology within further large scale and life sustaining markets. The Board is confident that AorTech has the technology, resources, partners and commitment to fully realise the potential of our unique Elast-EonTM polymer and thereby to build shareholder value over the coming years.' - Ends - For further information please contact: AorTech International plc Frank Maguire, Chief Executive Tel: + 1 801 201 4336 Evolution Securities Bobbie Hilliam Tel: +44 20 7071 4300 Chris Clarke Hogarth Partnership Limited Tel: +44 20 7357 9477 Melanie Toyne-Sewell/Sarah Richardson Notes to Editors: About AorTech International plc Listed on AIM in London, AorTech International plc wholly owns AorTech Biomaterials based in Melbourne, Australia. AorTech Biomaterials was formed in July 1997 to develop and commercialise Elast-Eon, a highly useful and biostable co-polymer in the medical device and drug delivery fields. AorTech's Elast-Eon technology is the product of a decade of fundamental research into biologically stable materials. Elast-Eon materials are patented, high silicone content, polyurethane copolymers which exhibit unparalleled biological and mechanical performance. AorTech is firmly focused on the development and refinement of this material for the medical community, with the aim of providing a wide range of high performance Elast-Eon materials in a variety of application specific formulations and densities, for use in medical devices. RESULTS FOR THE YEAR ENDED 31 MARCH 2007 CHAIRMAN'S STATEMENT I am pleased to report that in the year ended 31 March 2007 the Group made highly encouraging progress in a number of respects including the filing of three further patents. Moreover since the year end it has entered into a licensing and supply agreement for the evaluation of our patented polymer, Elast-EonTM, with a global medical device company. Accordingly, despite reporting an increased loss for the year, the Board believes that the Company can look forward to a very promising period ahead. Financial Review Group turnover for the year was £276,000. This was lower than the £1.4m in the previous year which included £1.1m from a one-off payment resulting from an agreement signed with St Jude Medical. Operating expenses for the year were £2,348,000, an increase of £481,000 over the previous year due, in the main, to the move to new premises in Australia and up-scaling of our operational capacity to meet the expected increase in demand for Elast-EonTM polymer. The operating expenses included £821,000 of development expenditure (2006: £634,000) and amortisation of intangible fixed assets amounting to £148,000 (2006: £99,000). The loss after tax for the year was £2.1m (2006: £523,000) and at 31 March 2007 the Group had cash reserves of £1.5m (2006: £2.7m). The greater part of this Statement focuses on the very important commercial and technical progress that has been and continues to be achieved. Operational Review Manufacturing and Supply of Elast-EonTM bulk material Following the granting of the regulatory approvals in the United States and Europe in 2006 for Elast-EonTM in human use, our principal operational focus for 2006/07 was to create a capable and reliable manufacturing infrastructure able to support the large scale and life-sustaining nature of our licensees' medical device products. I am pleased to report that our new Melbourne technology and manufacturing facility has achieved very positive results during the year, including 100% on-time delivery to customers, 100% quality certification and acceptance of delivered product and an overall reduction in the baseline costs from the previous year. This has been achieved in a period when we expanded our manufacturing capacity by 67%, which we believe is sufficient to satisfy our customers' growing polymer volume requirements through to the end of 2008. Elast-EonTM Component Manufacturing In response to our customers' requests for Elast-EonTM extrusions and mouldings, we have taken steps to improve our capability in the area of medical-grade extrusion. AorTech will benefit directly from the revenue associated with tubing component orders, and indirectly by accelerating the customer evaluation process and, therefore, the achievement of higher-value late stage development milestone payments that are characteristic of our material licence agreements. We are very encouraged by the results to date and expect that Elast-EonTM extrusion components will comprise a significant and increasing proportion of our polymer business revenues going forward. Market and Customers The major revenue potential and increased value return for the Group is expected to arise from joint venture projects and licensing agreements with major medical device companies. In addition, we estimate the market for our supply of bulk Elast-EonTM polymer to be approximately US$100m and growing at a rate of 6-10% per annum. We believe that our customers have recognised Elast-EonTM as a top quality silicone-urethane material for soft, long-term, high fatigue, blood-contacting implants. During the year, the technology focus has been towards developing softer materials which compete more directly with medical grade silicone, and we have expanded our patent portfolio by a number of new submissions and approvals. We have concentrated, in particular, on collaboration with major biomaterials research institutes and universities. As a result of this work we have achieved greater profile for Elast-EonTM, different aspects of which were presented at four separate conferences and also featured in three journal publications. During the year there were a number of customer evaluations carried out across a range of applications for Elast-EonTM. In addition to the work already underway in the areas of cardiac surgery, cardiology, orthopaedics and urology, we have invested and will invest further in other potential applications including neurostimulation, pulmonary, drug delivery, women's health, ventricular assist and non-coronary stent-based drug delivery, all of which are being developed within customer partnerships. Technology Developments Polymer Heart Valve During the past year, our heart valve technology has been evaluated in the in-house laboratories of major medical device companies who could become our partners in the future. This strategy is to enable us to demonstrate and verify the durability and performance characteristics of our heart valve product. We believe that good progress is being made towards the commercialisation of the Company's heart valve products within a co-development or partnership structure, and that these products have the potential to contribute significantly to our future revenues when regulatory and clinical milestones are achieved. Breast Implants The conditional re-approval of the gel-filled breast implant by the US FDA in November 2006 has had a substantial, immediate and long-term impact on breast implant technology and the related market dynamics. In the short term, the leading suppliers of these products are placing a strong focus on the re-introduction of such implants into the US. They have devoted significant resources to manufacturing processes, surgeon training and patient awareness programmes and the establishment of a clinical monitoring function capable of supporting the conditions upon which US FDA approved these silicone-gel implants. In the longer term, and because of the re-approval of the silicone-gel device, the market is seeking the next-generation product which we believe AorTech is well positioned to provide. During the past year, we have continued to refine our breast implant shell and filler materials, and to carefully examine these materials in relation to the guidelines published by FDA. We believe that the way forward for this technology is to secure a co-development deal with a suitable partner and we remain optimistic of achieving this. During the last year, we have filed three patents covering the use of our materials and newly invented processes in the fields of gel technology, in-situ cure and the development of a minimally invasive breast implant. In addition to the breast implant and heart valve projects, the Group has commenced new projects in the areas of urology, vascular grafts and non-coronary stent-based drug delivery. I look forward to reporting on progress with these projects in the coming year. Summary We have made very significant progress during the past two years in particular, having achieved multinational regulatory approvals, a reputation for quality and service, thousands of human implants of our premier biostable polymer, Elast-EonTM, and significantly increased operational capacity. Your Board believes that the recent announcement of a partnership deal for one of our major development programmes which, subject to AorTech fulfilling specific milestone targets, could realise income of up to approximately US$32m in the years ahead together with future royalty payments, and therefore validates our strategy to generate shareholder value through licensing and supply of an innovative, world-class polymer. Much credit for this progress goes to our Australian team based in their new Melbourne facility. Since the year end, we have raised £5.1m by way of a placing of 1,000,000 new Ordinary Shares which will provide us with the necessary resource to carry through our development plans. Finally I take this opportunity to thank all of our staff for their continued commitment to the Company and to our shareholders for their continued support over the past twelve months. Your Board is confident that AorTech has the technology, resources, partners and resolve to fully realise the potential of our unique Elast-EonTM polymer and thereby to build shareholder value over the coming years. Jon Pither Chairman CONSOLIDATED PROFIT AND LOSS ACCOUNT FOR THE YEAR ENDED 31 MARCH 2007 Notes 2007 2006 £000 £000 Turnover 2 276 1,425 Continuing operations Cost of Sales (158) (223) Gross Profit 118 1,202 Net operating expenses (2,348) (1,867) ---------------------------------------------- ------ --------- --------- Net operating expenses include: Development expenditure (821) (634) Amortisation of intangible fixed assets (96) (99) --------------------------------------------- ------ --------- --------- Group operating loss (2,230) (665) Interest receivable 109 142 Loss on ordinary activities before taxation (2,121) (523) Taxation - - Loss for the financial year (2,121) (523) Loss per ordinary share Basic and diluted 3 (55.67p) (13.74p) There is no difference between the losses stated above and their historical cost equivalent. All results are derived from continuing operations. CONSOLIDATED STATEMENT OF TOTAL RECOGNISED GAINS AND LOSSES FOR THE YEAR ENDED 31 MARCH 2007 2007 2006 £000 £000 Loss for the financial year (2,121) (523) Currency translation differences arising on (25) (23) consolidation Total losses recognised since last annual (2,146) (546) report CONSOLIDATED BALANCE SHEET AS AT 31 MARCH 2007 Notes 2007 2006 £000 £000 Fixed assets Intangible assets 1,262 1,360 Tangible assets 472 240 1,734 1,600 Current assets Stocks 89 140 Debtors: amounts falling due within one year 374 1,304 Cash at bank 1,480 2,716 1,943 4,160 Creditors: amounts falling due within one (520) (508) year Net current assets 1,423 3,652 Total assets less current liabilities 3,157 5,252 Creditors: amounts falling due after more (195) (144) than one year Net assets 2,962 5,108 Capital and reserves Called up share capital 9,526 9,525 Other reserve (2,003) (2,003) Profit & Loss account (4,561) (2,415) Equity shareholders' funds 2,962 5,108 CONSOLIDATED CASH FLOW STATEMENT FOR THE YEAR ENDED 31 MARCH 2007 Notes 2007 2006 £000 £000 Net cash outflow from operating activities 4 (904) (1,189) Returns on investment and servicing of finance Interest received 109 142 Taxation Research and development tax credits received - (99) Capital expenditure and financial investment Purchase of tangible fixed assets (420) (119) Net cash outflow from capital expenditure and (420) (119) financial investment Cash outflow before management of liquid resources (1,215) (1,265) and financing Management of liquid resources Cash released from short term deposit 1,592 1,658 Increase in cash in year 377 393 NOTES TO THE FINANCIAL STATEMENTS FOR THE YEAR ENDED 31 MARCH 2007 1 PRINCIPAL ACCOUNTING POLICIES The financial statements have been prepared in accordance with applicable United Kingdom Accounting Standards, up to and including Financial Reporting Standard ('FRS') 28. A summary of the more important Group accounting policies, which have been applied consistently, is set out below. The principal accounting policies represent the most appropriate in accordance with FRS 18. The summary accounts set out above do not constitute statutory accounts as defined by Section 240 of the UK Companies Act 1985. The summarised consolidated balance sheet at 31 March 2007, the summarised consolidated profit and loss account and the summarised consolidated cash flow statement for the year then ended have been extracted from the group's statutory accounts for the year to 31 March 2007 upon which the auditors' opinion is unqualified. The statutory accounts for the year ended 31 March 2007 were approved by the Directors on 6 September 2007, but have not yet been delivered to the Registrar of Companies. 2 SEGMENTAL ANALYSIS BY CLASS OF BUSINESS AND GEOGRAPHICAL AREA a) Class of business - The Group operates one class of business b) Geographical area- The analysis by geographical area of the Group's turnover, loss before tax and net assets is set out below: Turnover 2007 2006 sales by sales by sales by sales by destination origin destination origin £000 £000 £000 £000 Geographical segment United Kingdom 8 - 36 - Rest of Europe - - - - Rest of World 268 276 1,389 1,425 276 276 1,425 1,425 3 LOSS PER ORDINARY SHARE The basic loss per ordinary share is calculated on the loss of the Group of £2,121,321 (2006: loss of £523,348) and on 3,810,278 (2006: 3,810,278) equity shares, being the weighted average number of shares deemed to be in issue. The exercise of share options would not have been dilutive and accordingly the basic and diluted loss per share are the same. 4 RECONCILIATION OF OPERATING LOSS TO NET CASH FLOW FROM OPERATING ACTIVITIES 2007 2006 £000 £000 Group operating loss (2,230) (665) Amortisation of intangible fixed assets 133 99 Depreciation of tangible fixed assets 96 72 Loss on sale of fixed assets 53 - Decrease / (Increase) in stocks 51 (71) Decrease / (Increase) in debtors 930 (1,027) Increase in creditors 63 403 Net cash outflow from operating activities (904) (1,189) 5 NOTICE OF ANNUAL GENERAL MEETING Notice is hereby given that the tenth Annual General Meeting of AorTech International plc will be held at the offices of The Hogarth Partnership, 2nd Floor Upstream, No.1 London Bridge, London SE1 9BG on 2 October 2007 at 10:00am. 6 POSTING AND AVAILABILITY OF ACCOUNTS The annual report and accounts for the year ended 31 March 2007 will be sent by post to all registered shareholders on 6 September 2006. Additional copies will be available for a month thereafter from the Company's Surbiton office. Alternatively, the document may be viewed on, or downloaded from, the Company's website: www.aortech.com. This information is provided by RNS The company news service from the London Stock Exchange
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