Final Results

Aortech International PLC 31 August 2006 31 August 2006 Final Results for the year ended 31 March 2006 AorTech International plc (AIM: AOR) ('AorTech' or the 'Company'), the medical device development and biomaterials intellectual property and licensing company, today announces its final results for the year ended 31 March 2006. Operational Highlights • First US FDA Pre-Market Approval ('PMA') for use of Elast-Eon(TM) in a long-term life sustaining application • Agreement signed with St Jude Medical for exclusive use of Elast-Eon(TM) as cardiac rhythm management lead insulator • Expansion and relocation of Australian facility: o increased scale and stability of pilot polymer synthesis manufacturing capability o reduced manufacturing costs • Appointment of Eddie McDaid and Gordon Wright as Non-Executive Directors Post period end: • First human use of Elast-Eon(TM) in cardiac lead insulators achieved in July • Appointment of Medical Advisory Board comprising two highly esteemed plastic surgeons and researchers Financial Highlights • Turnover up over 900% to £1.42m (2005: £0.14m), of which £1.1m resulted from agreement signed with St Jude Medical • Operating expenses reduced by 15% to £1.87m (2005: £2.19m) • Loss after tax reduced by 72% to £0.52m (2005: Loss £1.87m) • Net cash position of £2.72m (2005: £4.02m), reflecting investment in development projects Commenting on the results, Jon Pither, Chairman of AorTech, said: 'The positive results of the year are a culmination of the efforts of the past three years. These efforts have enabled the Company to focus on realising the potential of its Elast-Eon(TM) material and to deliver the first major commercialisation of Elast-Eon(TM) in a medical device product through our licence and supply agreement with St. Jude. Having achieved this first commercialisation agreement I am confident that this will be the first of several licence and supply agreements over the coming years. Our Company is now achieving a financial and cash flow stability that we have been seeking to create since 2003.' -Ends- Enquiries: AorTech International plc Tel: 020 7357 9477 (on 31 August) Frank Maguire, CEO Hogarth Partnership Limited Tel: 020 7357 9477 Melanie Toyne-Sewell / Sarah Richardson Notes to Editors: AorTech International plc is a public limited company formed under the laws of Scotland, UK and is traded on the Alternative Investment Market, a market operated by the London Stock Exchange plc, under the trading symbol AOR. Additional material concerning AorTech International is available on the Company's website at www.aortech.com, or may be obtained by contacting the Company's Public Relations firm, Hogarth Partnership Limited. AorTech International plc: Prestige Travel Suite, Barclays Bank House, 81-83 Victoria Road, Surbiton, Surrey, KT6 4NS, UK Chairman's statement Financial year ended 31 March 2006 saw the first significant income for the biomaterials-focused business strategy that has been under development since 2003. Results Results to date are reflected in the summary financial performance of the business: For the year ended 31 March 2006, the Company's turnover was £1,424,944, representing a more than 10-fold increase over the previous year's £136,958. Approximately £1.1million of the 2006 turnover resulted from the agreement signed with St. Jude Medical. As the substance of the transaction is that of a sale of rights to the use of Elast-Eon(TM) in specified fields of use, this has been recognised as revenue in these financial statements. Operating expenses for the year were £1,867,740, representing a reduction of almost 15% over the previous year and being 26% less than the figure for 2004. The operating expenses included £634,292 of development expenditure (2005: £653,896) and amortisation of intangible fixed assets of £99,491 (2005: £94,589). The Loss after Tax for the year was £523,348, which compares with the loss for 2005 of £1,867,390. The cash position as at 31 March 2006 was £2,715,804, which compares with £4,015,126 on the corresponding day in 2005. However, the cash position improved significantly in April 2006 with the receipt of the US$2million (approximately £1.1million) initial payment from St. Jude Medical in respect of the agreement concluded prior to the financial year end. Other tangible measures of progress came in the form of the first US FDA Pre-Market Approval ('PMA') for the use of our Elast-Eon(TM) material in a long-term, life sustaining application and the agreement reached with St. Jude Medical for exclusive use of Elast-Eon(TM) as insulation for its cardiac pacing products. Post year end, an extremely important event occurred in July 2006 when Elast-Eon(TM) achieved first human use as a cardiac rhythm management lead insulator. Our general strategy is to build a profitable, cash positive, polymer licensing and supply business and to leverage that base with selected device development projects with high potential returns, such as heart valve and breast implant, with which the directors expect to enhance shareholder value. Elast-Eon(TM) licensing and supply As FDA approval of our product became known in the marketplace and our contract with St. Jude Medical was announced, there was a substantial increase in new customer enquiries. Almost any clinical use of our polymer requires a lengthy cycle of application development and testing followed by a regulatory approval phase. However, as a consequence of PMA approvals and first human use, customer interest has risen and we anticipate an increasing number of clinical applications to be approved during the coming financial year. We would expect these to be focused mainly on orthopaedic and cardiac surgery applications, although there are additional client development programmes underway in cardiology and urology, among others. During the period, under the guidance of our Chief Scientific Officer, Dr. Ajay Padsalgikar, we also continued to expand our technology offerings with the development of new softer grades of Elast-Eon(TM), an Elast-Eon(TM) gel and an injectable form of Elast-Eon(TM). Patent applications have been made for all of these materials. Device Development The two most significant internal projects I wish to report on are the polymer heart valve and the breast implant. Polymer heart valve The global prosthetic heart valve market is in excess of $1 billion and growing at approximately 6% per annum. Various estimates suggest that the potential market for percutaneous heart valves is equivalent in size to the surgical heart valve market. Over the past several years, Bovine Spongiform Encephalopathy (BSE) has emerged as a risk factor in the use of tissue heart valves manufactured from animal tissue. A polymer heart valve removes this risk. There has been increased interest from both industry and investors in catheter-delivered (percutaneous) heart valve technology. A percutaneous heart valve has the advantage of being delivered to the heart via a catheter inserted through an incision in the groin, thus avoiding conventional open-chest surgery utilising cardio-pulmonary bypass. This approach provides a therapeutic option for patients not strong enough to undergo a conventional open-chest procedure. The AorTech polymer valve offers significant advantages in size and ease of use as compared with other, tissue-based percutaneous designs, making this therapy available for smaller patients. The strength of this increased industry interest in catheter-delivered heart valves can be demonstrated by the Edwards Lifesciences' acquisition in October 2004 of Percutaneous Valve Technology Company (PVT), for a reported $125million up front payment. The AorTech polymer valve offers a significant advantage in manufactured cost versus other commercially available heart valve products, making it ideally suited for large emerging markets such as China and India. AorTech's Strategy: Prior to suspending our UK based heart valve development programme in the summer of 2003, two key objectives were attained. These were the filing of patents for the 'high durability' polymer valve known as M-95-C in both surgical and percutaneous forms and the demonstration of a soft failure mode for this valve. This 'soft' failure mode is similar, and our data suggests even somewhat superior, to that of commercial tissue heart valve products in widespread distribution. The significance of a soft failure mode is that, unlike a mechanical valve where failure almost always results in death, a patient with a failing polymer or tissue valve will exhibit symptoms of the failing valve, providing an opportunity for an intervention to correct this situation, thus preserving the life of the patient. As a result of these technology and market factors there has been a general level of renewed interest by outside parties in our AorTech polymer valve. This interest level has been significant and has led to our decision to recommence the AorTech polymer valve programme. We have recruited Dr. Jason Beith, the inventor of the recently patented M-95-C valve to lead our development project team. We are seeking an industry partner to assist in the development programme and believe that we have made progress towards identifying a partner who will provide the necessary resources to continue the pre-clinical development and testing on our polymer valve. This would enable the valve project to be taken successfully to clinical trials in future years with the ultimate objective being the commercialisation of this heart valve in areas of surgical, minimally invasive and percutaneous manifestations. I look forward to reporting on the progress towards a partnership for the development of the AorTech polymer valve within the next year. On 26 March 2006 our M-95-C patent was issued in the UK and we anticipate that it will be issued in all major territories over the next 18-24 months. Breast Implant Worldwide, 800,000 women will receive breast implant products in the coming year. More than 90% of these will be for purely cosmetic reasons. Although some form of re-approval by US FDA of a silicone gel-filled implant is anticipated in the near future, we believe that the case for the use of an Elast-Eon(TM) gel filler in existing implants can be made on the basis of both product and patient safety. Our product avoids the use of platinum or tin - or indeed any metal catalyst in the material - and offers a substantive reduction in low molecular weight compounds compared with the silicone material that characterises existing silicone breast implant products. It is our opinion, therefore, that the anticipated US FDA approval of silicone gel products will be a positive development for AorTech as it will reintroduce a technology factor into market competition for devices that have been in regulatory limbo for 14 years. We have been developing a minimally invasive gel implant technology that we believe may be of significant interest to both the industry and the market. This technology will permit a gel implant procedure, without damage to the shell, and secure the benefits of the safer Elast-Eon(TM) gel. We are not aware of any other next generation breast implant technology like this. Our future development programme over the coming months is to pursue proof of concept for the minimally invasive breast implant and to select a partnership where the development programme can be taken to clinical trials and ultimately commercial use. Patents have been filed for this minimally invasive breast implant device. Operational Update In May 2006, our Australian operation moved into a new and expanded facility located on a technology campus in Scoresby, Melbourne, approximately 3 miles from our prior location. As a result of this relocation we have been able to both scale up and stabilise our pilot polymer synthesis manufacturing capability. Together with the improvement in polymer quality levels, we are able to achieve a significant reduction in the polymer manufacturing cost. We anticipate that our new capacity levels are adequate for the foreseeable future. Substantive funding for the infrastructure elements of this move were obtained from the Australian State of Victoria. This move is an endorsement of the success of AorTech's team in Victoria and the quality of local support available to a high technology business. Board Changes In November 2005, we announced the appointment of Eddie McDaid and Gordon Wright as Non-Executive Directors of the Company. Their knowledge of the Company and the industry in which we operate is wide ranging, and their input has been much welcomed by their colleagues on the Board. Outlook Over the coming year we expect the early adopters of Elast-Eon(TM) technology in the fields of cardiology, orthopaedics and urology to provide the momentum for moving this segment of the business forward. We have prepared our operations for this new business and are confident of our product quality, capacity of manufacturing and new cost basis. During the same period, we expect to be announcing significant developments in the use of Elast-Eon(TM) in orthopaedic applications and we anticipate the formation of a co-development partnership with an industry partner for our heart valve technology. Current trading remains in line with the Board's expectations. In Conclusion The positive results for the year are a culmination of the efforts of the past three years, following the downsizing of the organisation and its activities during 2002/2003. These efforts have enabled the Company to focus on realising the potential of its Elast-Eon(TM) material and to deliver the first major commercialisation of Elast-Eon(TM) in a medical device product through our licence and supply agreement with St. Jude Medical. Having achieved this first commercialisation agreement I am confident that it will be the first of several licence and supply agreements over the coming years. Our Company is now achieving a financial and cash flow stability that we have been seeking to create since 2003. None of this progress or these achievements would have been possible without the expertise, drive and commitment of our employees in Australia, whom I thank, on behalf of myself and the Board, for their outstanding service. I have to also thank my fellow Board members and in particular our Chief Executive, Frank Maguire, for his sterling work during the past twelve months in delivering the positive results and indeed the major turnaround that the Company has achieved during the year ended 31 March 2006. Finally, I take this opportunity to thank our shareholders for their continued support over the years. I am confident that AorTech can build on its achievements of the past twelve months and that the potential of our unique Elast-Eon(TM) material will continue to add value to the company over ensuing years. Jon Pither Chairman Consolidated Profit And Loss Account for the year ended 31 March 2006 Notes 2006 2005 £ £ Turnover 2 1,424,944 136,958 Cost of Sales 3 (222,751) (31,339) ---------- ---------- Gross profit 1,202,193 105,619 Net operating expenses 3 (1,867,740) (2,189,908) ----------------------------------------- ------ ---------- ---------- Net operating expenses include: Development expenditure (634,292) (653,896) Amortisation of intangible assets (99,491) (94,589 ) ----------------------------------------- ------ ---------- ---------- Group operating loss 3 (665,547) (2,084,289) Interest receivable 142,199 216,899 ---------- ---------- Loss on ordinary activities before taxation 2 (523,348) (1,867,390) Taxation 5 - - ---------- ---------- Loss for the financial year (523,348) (1,867,390) ========== ========== Loss per ordinary share 6 Basic (13.74p) (49.01p) Diluted (13.74p) (49.01p) Consolidated Statement of Total Recognised Gains and Losses for the year ended 31 March 2006 2006 2005 £ £ Loss for the financial year (523,348) (1,867,390) Currency translation differences arising on consolidation (22,981) (45,215) ---------- ---------- Total losses recognised since last annual report (546,329) (1,912,605) ========== ========== Balance Sheets as at 31 March 2006 Group 2006 2005 £ £ Fixed assets Intangible assets 1,360,209 1,449,366 Tangible assets 239,775 189,678 Investment in subsidiary undertakings - - ----------- ----------- 1,599,983 1,639,044 Current assets Stocks 139,637 68,852 Debtors: amounts falling due within one year 1,304,424 278,948 Debtors: amounts falling due after more than one year - - Cash at bank 2,715,804 4,015,126 ----------- ----------- 4,159,865 4,362,926 Creditors: amounts falling due within one year (508,371) (348,460) ----------- ----------- Net current assets 3,651,494 4,014,466 Total assets less current liabilities 5,251,478 5,653,510 Creditors: amounts falling due after more than one year (144,297) - ----------- ----------- Net assets 5,107,181 5,653,510 =========== =========== Capital and reserves Called up share capital 9,525,695 9,525,695 Other reserve (2,003,143) (2,003,143) Profit and loss account (2,415,371) (1,869,042) ----------- ----------- Equity shareholders' funds 5,107,181 5,653,510 =========== =========== Consolidated Cashflow Statement for the year ended 31 March 2006 notes 2006 2005 £ £ Net cash outflow from operating activities 7 (1,188,804) (2,119,791) Returns on investment and servicing of finance Interest received 142,199 216,899 Taxation Research and development tax credits refunded (98,899) - Capital expenditure and financial investment Purchase of tangible fixed assets (119,759) (28,000) --------- --------- Net cash outflow from capital expenditure and financial investment (119,759) (28,000) Cash outflow before management of liquid resources and financing (1,265,263) (1,930,892) Management of liquid resources Cash released from short term deposit 1,658,461 1,994,364 --------- --------- Increase in cash in the year 393,198 63,472 ========= ========= Notes to the Financial Statements for the year ended 31 March 2006 Note 1 This statement has been prepared using accounting policies and presentation consistent with those applied in the preparation of the statutory accounts of the Group. The principal accounting policies represent the most appropriate in accordance with FRS 18. The new standards that are appropriate to the Group (namely FRSs 21, 22, 25 and 28) had no material impact on the financial statements. The summary accounts set out above do not constitute statutory accounts as defined by Section 240 of the UK Companies Act 1985. The summarised balance sheet at 31 March 2006, 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 2006 upon which the auditors' opinion is unqualified. The statutory accounts for the year ended 31 March 2006 were approved by the Directors on 30 August 2006, but have not yet been delivered to the Registrar of Companies. Note 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: (i) Turnover 2006 2005 Sales by Sales by Sales by Sales by destination origin destination origin £ £ £ £ Geographical segment United Kingdom 35,870 - 13,024 - Rest of World 1,389,074 1,424,944 123,934 136,958 --------- --------- -------- -------- 1,424,944 1,424,944 136,958 136,958 ========= ========= ======== ======== (ii) (Loss) / Profit before taxation 2006 2005 £ £ Geographical segment United Kingdom (689,206) (957,192) Rest of World 23,659 (1,127,097) -------- -------- Loss before interest (665,547) (2,084,289) Net interest receivable 142,199 216,899 -------- -------- Loss on ordinary activities before taxation (523,348) (1,867,390) ======== ======== (iii) Net assets 2006 2005 £ £ Geographical segment United Kingdom 2,127,732 3,733,878 Rest of World 2,979,449 1,919,632 --------- --------- 5,107,181 5,653,510 ========= ========= Note 3: Net operating expenses Net operating expenses of £1,867,740 (2005: £2,189,908) also include Selling and Marketing Costs of £243,739 (2005: £185,384) and Other Administrative Expenses of £890,218 (2005: £1,256,039). Note 4: Operating Loss 2006 2005 £ £ The operating loss is stated after charging: Depreciation and amortisation charge for the year: Intangible owned assets 99,491 94,589 Tangible owned fixed assets 72,406 70,948 Operating lease rentals: Other 90,931 138,689 The above results for the year relate to continuing operations. Note 5: Taxation No tax arises on the loss for the year (2005: nil) Unrelieved tax losses remain available to offset against future taxable profits of the same trade in the same country. These losses have not been recognised as deferred tax assets within the financial statements as they do not meet the conditions required in accordance with FRS 19. Losses carried forward in the UK total £2,401,144 - tax effect is £720,343 (2005: £1,840,679 - tax effect is £552,204). Losses carried forward in Australia total £4,304,906 - tax effect £1,291,472 (2005: £4,404,615 - tax effect £1,321,384). Note 6: Loss per Ordinary Share The basic loss per ordinary share is calculated on the loss of the Group of £523,348 (2005: loss of £1,867,390) and on 3,810,278 (2005: 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. Note 7: Reconciliation of Operating Loss to Net Cash Flow from Operating Activities 2006 2005 £ £ Group operating loss (665,547) (2,084,289) Amortisation of intangible assets 99,491 94,589 Depreciation of tangible fixed assets 72,406 70,948 Increase in stocks (70,785) (20,199) Increase in debtors (1,027,476) (91,100) Increase / (decrease) in creditors 403,107 (89,740) --------- --------- Net cash outflow from operating activities (1,188,804) (2,119,791) ========= ========= Note 8: Notice of Annual General Meeting The Annual General Meeting will be held at 12 noon on 28 September 2006 at the offices of Biggart Baillie, Dalmore House, 310 St Vincent Street, Glasgow G2 5QR. Note 9: Posting and availability of accounts The annual report and accounts for the year ended 31 March 2006 will be sent by post to all registered shareholders on 5 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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