Final Results

Aortech International PLC 23 May 2001 AORTECH INTERNATIONAL PLC Preliminary Results for the Year Ended 31 March 2001 Aortech International plc, the Scottish-based manufacturer of cardio-vascular devices, announces its Preliminary Results for the year ended 31 March 2001. Highlights * Year of continued progress * Turnover increased 17% to £4.1 million * Loss for the year £6.2 million - in line with expectations, reflecting increased marketing & development expenditure * TruCCOMS - CE mark secured; initial sales made * Elast-Eon - Supply and Licence Agreement with JOMED signed * Post year end - £20m fundraising completed; operations now fully funded for over 2 years - TruCCOMS - distribution agreement signed Gordon Wright, Chairman, commented: 'The past year has seen continued progress on all of AorTech's activities both for our established products and our new technologies. We are pleased to report increased sales in our established products. Since the year end, we have concluded a further fund raising thereby providing the additional resources for the Group to continue its development programme, to commercialise certain products and to commence clinical trials of our innovative technologies. The continued successful development of our outstanding new technologies, TruCCOMS, the new Tri-Leaflet Heart Valve and the Elast-Eon Material will, we are confident, deliver long-term growth for Aortech and its shareholders.' 23 May 2001 ENQUIRIES: Aortech International plc Tel: 01698 746 699 Eddie McDaid, Chief Eecutive Bell Lawrie White & Co Tel: 0141 221 7733 Clive Thomson / Elizabeth Kennedy Nomura International plc Tel: 020 7521 2000 David Porter College Hill Tel: 020 7457 2020 Michael Padley / Nicholas Nelson Chairman's and Chief Executive's Joint Statement The past year has seen continued progress on all of AorTech's activities both for our established products and our new technologies. We are pleased to report increased sales of our established products from the preceding year relating primarily to our bio-prosthetic tissue heart valves together with the initial sales of our new Continuous Cardiac Output Monitoring System (TruCCOMS) which commenced in the last three months of the financial year. The increased sales of bio-prosthetic valves reflect the shift in the replacement heart valve market from mechanical valves to bio-prosthetic (tissue) valves throughout the World. It is anticipated that there will be significant growth in AorTech's sales during the course of the current financial year with a further increase in our bio-prosthetic valves expected and an initial full year contribution of our TruCCOMS system. The continued successful development of our outstanding new technologies, TruCCOMS, the New Tri-leaflet Heart Valve and the Elast-Eon Material will, we are confident, deliver long-term growth for AorTech and its shareholders. Since the year end, we have concluded a further fund raising of approximately £20 million gross which will provide the additional resources for the Group to continue to deliver progress on our innovative technologies. Sadly adverse stock market conditions in the early part of the year made it impossible to complete a larger fund raising in March of approximately £64 million which would have allowed us to fully commercialise our new products and seek complementary acquisitions. TruCCOMS Technology European regulatory authorities approved the CE Mark for our TruCCOMS technology in August 2000 after successful clinical trials in patients. Two papers have already been presented on the clinical results, from patients in the United Kingdom and a further paper submitted for presentation at the American Society for Anaesthesiologist in October, 2000 from patient results in the USA. These papers demonstrated the safety and reliability results of TruCCOMS. There are and will continue to be ongoing studies for TruCCOMS in various hospitals throughout the World and we are confident that the results of these studies will assist the marketing of the product over the ensuing years. Full marketing and sales of TruCCOMS commenced in the last quarter of the financial year and the results of these sales are encouraging with the acceptance of the device by surgeons and anaesthetists in patient management during and after surgery. Early results have in particular demonstrated the additional benefits which TruCCOMS provides for patients having open heart surgery on their 'beating hearts', known as 'off pump surgery'. During these critical operations the TruCCOMS monitor provides surgeons and anaesthetists with the ability to determine changes in patients' cardiac output immediately and to take the necessary corrective action, thus providing improved patient management. Several key European Centres have adopted the TruCCOMS technology including one of the major hospitals in Germany where the system is being used during routine coronary artery bypass (CABG surgery) and in Italy during coronary artery bypass grafting where patients are undergoing 'off-pump surgery.' The immediate response of TruCCOMS to changes in patients' cardiac output enables surgeons to monitor the success of the coronary grafts as they are completed. We have announced the signing of a Distribution Agreement with Becton Dickinson, one of the world's leading medical device companies, for distribution of TruCCOMS initially throughout Europe and the Middle East. This Agreement is clear evidence of the future marketing and sales potential of TruCCOMS. There are ongoing studies in both the USA and Europe in respect of the use of the TruCCOMS technology during angioplasty procedures i.e. procedures for elimination of areas of narrowing in blood vessels. The purpose of these studies is to show that TruCCOMS can allow physicians to determine the potential success of angioplasty procedures as they are being carried out. The studies will continue and, if successful, would represent a major new application for our technology in this significant market area. New Tri-leaflet Heart Valve Our Tri-leaflet Heart Valve will soon reach the stage of regulatory testing that is required prior to the clinical trials in patients which are anticipated to commence in mid 2002. Continued progress has been achieved during the past twelve months with several versions of the valves reaching critical durability levels in excess of 600 million cycles corresponding to approximately 15 years in patients. This is the number of cycles, under regulatory conditions, required by the FDA prior to approval for patient trials in the USA. A further paper was presented at the American BioMaterials Conference in Minneapolis in April 2001 demonstrating the excellent results from explanted valves. In addition, the paper previously presented at the European Association of Artificial Organs Congress in Switzerland in September 2000 has subsequently been published in the International Journal of Artificial Organs. Elast-Eon Material The Elast-Eon material is continuing to be evaluated by a number of medical device companies for utilisation in a range of medical device applications. In January we concluded a Supply and Licence Agreement with JOMED, a major European cardiovascular device company focusing on the manufacturing and sales of stents which are utilised during certain angioplasty procedures by insertion within the vessel to maintain patency. One of the objectives of medical companies involved in the stent market (which is approximately £1.5 billion) is to reduce the restenosis i.e. the re-narrowing or contraction of the vessel or artery. Having evaluated and assessed Elast-Eon over the past 18 months, it is JOMED's aim to utilise the material to improve the performance of its stents and reduce the restenosis rates. With the number of Evaluation Agreements presently in place we are confident that further Supply and Licence Agreements will be completed during the course of this financial year. The continued positive results of Elast-Eon within our new heart valve project demonstrates the unique properties of the material, and in particular its outstanding biostability. The Group's facility in Melbourne has been expanded to incorporate the additional personnel and equipment required to increase production and we are pleased to report that this facility has recently received confirmation of its ISO 9001 manufacturing accreditation. This is an important step in the development and progress of the AorTech Biomaterials Division, which we anticipate will have significant long term potential for AorTech. Executives and Staff The continued progress of AorTech can only be sustained with the commitment of all of our employees within the Group and we shall continue to build on the professional and quality staff which we have at present to ensure the Group capitalises on its outstanding range of technologies. New Senior Appointments We are pleased to confirm the appointment of the following Senior persons:- Jonathan Brooks, Non-Executive Director Graham McKay, Development Director Paul Burns, Quality and Regulatory Director Jonathan Brooks was appointed a Non-Executive Director of the company in February 2001 and is a member of the company's Audit, Remuneration and Nomination Committees. Jonathan is Chief Financial Officer of ARM Holdings plc, a company quoted on both the London Stock Exchange and NASDAQ. Jonathan will provide additional experience and further strengthens AorTech's Board of Directors. There has been significant expansion in the project teams within our new facilities in Scotland including the appointments of Graham McKay as Development Director and Paul Burns as Quality and Regulatory Director. Graham was Director of New Product Development for SSL International and prior to that was Business Development Manager and Technical Manager for Johnson & Johnson. He has twenty years' experience in biomaterials and medical products. Paul Burns has in excess of fifteen years' experience in the medical device sector, his most recent position being Quality Assurance and Regulatory Affairs Manager for Sulzer Vascutek Limited, a wholly owned subsidiary of Sulzer Medica, a major global medical device company. Scientific Advisory & Medical Advisory Group The company established, in November 2000, a Scientific Advisory Group and a Medical Advisory Group. The aim of the Scientific Advisory Group is to assist the Company in the resolution of important scientific and technological issues and the identification of opportunities for further developments based upon AorTech's new technologies and core competencies. The members of the Group are among the world's leading authorities in their various fields. The Medical Advisory Group, whose members are physicians and surgeons of international renown, has been set up with the aim of assisting and providing medical advice to AorTech on various clinical issues in relationship to our products and technologies as we bring them forward from the development phase to the regulatory phase and into clinical trials in patients. Future Prospects We have, in common with our shareholders, been disappointed at the decrease in the share price and market capitalisation of the Group. It is, however, important to recognise that the underlying technologies and projects have continued to progress; that regulatory work will be commencing in the very near future on the new heart valve project; that marketing and sales of TruCCOMS have commenced; and that the first Supply and Licence Agreement has been concluded on Elast-Eon. We are confident that the continued progress on all of our technologies during the current year will be maintained and accelerated and therefore there should be further growth and value to the AorTech Group. We thank all of our Directors and employees throughout the Group for their significant contribution over the past year but in particular thank our Shareholders for their forbearance, understanding and in particular their continued support for the Group which was demonstrated by their participation in the recent successful fund raising. Eddie McDaid Gordon Wright Chief Executive Chairman Consolidated Profit and Loss Account Note 2001 2000 £ £ Turnover 2 4,050,585 3,452,246 Cost of sales (2,004,486) (1,359,304) Gross profit 2,046,099 2,092,942 Selling and marketing costs (1,065,257) (744,627) Administrative expenses (7,953,999) (3,096,390) Administrative expenses include: Development expenditure (4,626,361) (1,476,626) Amortisation of intangible fixed (1,235,148) (162,093) assets Group operating loss (6,973,157) (1,748,075) Share of operating loss of associate - (85,128) Loss on operating activities before (6,973,157) (1,833,203) interest Interest receivable 785,838 113,911 Interest payable (25,755) (45,189) Loss on ordinary activities before and (6,213,074) (1,764,481) after taxation Loss per ordinary share Basic 3 (20.71p) (7.71p) Diluted (20.71p) (7.71p) Statement of Total Recognised Losses Loss for the financial year (6,213,074) (1,764,481) Currency translation differences arising (211,990) (2,020) on consolidation Total recognised losses relating to the (6,425,064) (1,766,501) year Prior year adjustment 4 - (919,193) Total losses recognised since last report (6,425,064) (2,685,694) Consolidated Balance Sheet 2001 2000 £ £ Fixed Assets Intangible Assets 22,137,882 23,540,817 Tangible Assets 2,535,126 1,252,521 24,673,008 24,793,338 Current Assets Stocks 2,165,530 1,957,466 Debtors 3,369,254 1,583,860 Cash at Bank 8,325,970 16,032,106 13,860,754 19,573,432 Creditors: amounts falling due within one year (2,377,592) (2,371,631) Net Current Assets 11,483,162 17,201,801 Total Assets less Current Liabilities 36,156,170 41,995,139 Creditors: Amounts falling due after more than - (364,472) one year Accruals and Deferred Income (139,734) (78,329) Net Assets 36,016,436 41,552,338 Capital and Reserves Called Up Share Capital 7,547,341 7,284,841 Share Premium Account 42,160,934 41,534,272 Other Reserve (2,003,143) (2,003,143) Profit and Loss Account (11,688,696) (5,263,632) Equity Shareholders' Funds 36,016,436 41,552,338 Consolidated Cash Flow Statement Note 2001 2000 £ £ Net cash outflow from operating (5,096,432) (2,084,253) activities Returns on investment and servicing of 812,130 58,522 finance Capital expenditure and financial (1,917,169) (2,016,897) investment Acquisitions and disposals - (822,689) Cash outflow before management of liquid resources and (6,201,471) (4,865,317) financing Management of liquid resources 7,831,938 (14,879,507) Financing 5 (1,461,733) 20,320,644 Increase in cash in year 168,734 575,820 Note 1 The financial information set out in this Announcement has been abridged from the Annual Report for the year ended 31 March 2000 and the unaudited accounts for the year ended 31 March 2001. The statutory accounts for the year ended 31 March 2000 were reported on by the Auditors, PricewaterhouseCoopers, without qualification and have 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 in one class of business (b) geographical area 2001 2000 destination origin Destination origin £ £ £ £ Geographical segment United Kingdom 888,922 3,228,063 746,611 2,794,200 Rest of Europe 2,870,108 726,399 2,657,063 658,046 Rest of World 291,555 96,123 48,572 - 4,050,585 4,050,585 3,452,246 3,452,246 Note 3 Loss per ordinary share The basic loss per ordinary share is calculated on the loss of the group of £ 6,213,074 (2000 - £1,764,481) and 29,999,033 (2000 - 22,887,273) equity shares being the weighted average number of shares deemed to be in issue. The exercise of stock options would not be dilutive. Note 4 Prior Year Adjustment - Year ended 31 March 2000 During the year ended 31 March 2000, the Company changed its accounting policy on development expenditure. Previously, such development expenditure relating to specific projects intended for commercial exploitation was carried forward where the ultimate commercial viability had been assessed with reasonable certainty. Under the new accounting policy, all development expenditure is written off as incurred. The effect of moving to this new policy was to increase the loss for the year ended 31 March 2000 by £1,561,754. The change of policy also reduced shareholders' funds by £919,193 as at 1 April 1999. Note 5 Financing Financing payments during the year ended 31 March 2001 include £1,023,098 relating to the issue of shares in May 2001. Copies of this statement will be available for a period of 14 days from the Company's registered office: Phoenix Crescent, Strathclyde Business Park, Bellshill, Scotland, ML4 3NJ.
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