Final Results

Aortech International PLC 28 June 2002 AORTECH INTERNATIONAL PLC Preliminary results New CEO appointed AorTech International plc, the Scottish-based manufacturer of cardio-vascular devices, announces its Preliminary Results for the year ended 31 March 2002. HIGHLIGHTS • Product sales increase 25% to £4.6 million • TruCCOMS adopted by 33 centres, further 34 continuing evaluation • Tri-leaflet heart valve entered regulatory trials; commenced October 2001 • Second Elast-eon agreement signed • Cash reserves at the year end were £16.6 million Post period Events • CEO appointed, Board restructured • Manufacturing rationalised; sub-contract agreement with BD (Becton Dickinson) • Letter of Intent to acquire BD Critical Care division Eddie McDaid, Chairman, commented: 'The past year has been one of change for the Company. Although the Company has made continued progress in the development of our technologies I, together with the Directors, share the disappointment of our shareholders with the performance of our share price in what have been difficult market conditions for many technology stocks. Although delays in both our clinical trials and sales of our TruCCOMS system have been experienced, the Group is now moving from being focused on the development of innovative technologies to their commercial exploitation. 'The search for the Chief Executive has been concluded with the appointment of Bill Strachan and we have taken the opportunity to rationalise and restructure the Board in order to streamline the corporate structure. 'We have made the necessary changes to strengthen the Senior Management of the Company to ensure the success of this commercialisation programme. The changes which have been implemented have enabled a platform to be put in place to ensure a promising future for our company.' Bill Strachan commented: 'I am excited by the new challenge. AorTech has had a difficult year but they retain several outstanding technologies which are ready to be commercialised. I see it as my role to build upon the work done to date and to ensure that we are successful in exploiting the world leading technologies.' 28 June 2002 ENQUIRIES: AorTech International plc Tel: 01698 746 699 Eddie McDaid, Chief Executive Bell Lawrie White & Co Tel: 0141 221 7733 Clive Thomson / Elizabeth Kennedy College Hill Tel: 020 7457 2020 Michael Padley / Clare Warren CHAIRMAN'S STATEMENT I am pleased to present the Preliminary Statement for AorTech International plc for the year ended 31 March 2002. General The past year has been one of change for the Company, with our Chairman, Gordon Wright standing down in March for health reasons. Gordon and I founded AorTech in November 1992 and he was instrumental in the development of the Group, particularly in those early years. In wishing him well for the future, I take this opportunity to thank Gordon for his vision, support, commitment and contribution towards the development and growth of AorTech. Management Changes You will know that, following Gordon's departure, I assumed the responsibilities of both Chairman and Chief Executive until a suitable candidate could be selected to take on the Group Chief Executive position. The search for the Chief Executive has been concluded and I have pleasure in announcing the appointment of Bill Strachan to this important position with effect from 1 July 2002. Bill is a highly experienced Senior Executive within the Medical Device Industry. He was most recently Vice President and General Manager of Europe of the Infection Prevention Systems Division in a highly successful 24 year career with Johnson & Johnson and has been responsible for the creation of high growth and profitable businesses in a number of different medical device areas. Under his guidance these businesses consistently achieved positions of market leadership in their worldwide segments. His early career was spent in the pharmaceutical industry, with another world class organisation the Eli Lily & Co Group. Bill's appointment brings, we believe, the appropriate expertise and leadership required to redress the fortunes of the Company and to enable the underlying value of the Group's technologies to be realised. I am also pleased to announce the appointment of Frank Maguire to the Executive Management team. Frank replaces John Ranieri, who due to personal circumstances, leaves the Company at the end of August 2002. Frank has extensive experience in the cardiovascular area and has 24 years experience in the medical device industry. Frank was Vice-President of Baxter Research Medical, a division of the Baxter Healthcare Group and guided this division through a period of substantial growth via acquisitions in the late nineties, introducing new products to the market and establishing innovative product lines for Baxter Healthcare. We have taken the opportunity to rationalise and restructure the Board, which has been done in accordance with Corporate Governance best practice in order to streamline the corporate structure. John McKenna, Dr Peter Duijst, Bruno Lowinger, Professor David Williams and John Ranieri will retire from the plc Board on 1 July 2002. I would like to take this opportunity of thanking these Directors, who are continuing their executive responsibilities within the AorTech Group, for the significant contribution they have made during their period of office on the Board. With effect from 1 July 2002, the plc Board will comprise myself, as Chairman, Bill Strachan, Chief Executive and Ian Cameron, Finance Director, with Alistair Gray, Francis Madden and Jonathan Brooks as non Executive Directors. Proposed Acquisition of the Critical Care Products of Becton Dickinson We announced on 9 April 2002 that we had entered into a non binding Letter of Intent with BD (Becton Dickinson & Co) to acquire BD's critical care business. However, due to technical issues which arose recently, there has been a delay in the completion of this transaction. Negotiations in relation to the definitive agreements and funding are near to completion, with funding in place. Assuming that the technical issues are resolved to our satisfaction, we would hope to conclude the acquisition shortly. Results The results for the year ended 31 March 2002 show a loss of £12.9 million against a loss of £6.2 million for the previous year. The increased loss is stated after charging £6.8 million in respect of development expenditure written off during the year, £2 million in respect of depreciation and amortisation and £1.3 million in respect of exceptional costs incurred on the proposed acquisition of BD. Cash reserves at the year end were £16.6 million. We have introduced a change in accounting policy by adopting a conservative stance on revenue recognition which, although not covered under UK Accounting Standards, is a requirement under US Accounting Standards. Sales were previously invoiced by the Company in certain circumstances on a bill and hold basis, whereby customers were invoiced for goods but the Company, at the customer's request, held and delivered them by instalments. These sales are not now recognised as sales revenue until the goods are received by the customer. The Board feel that this is a prudent position to take. As a result of this adjustment, the sales decreased by approximately £82,000 during the year to 31 March 2002 and losses increased by approximately £72,000. Although our product sales increased to £4.6 million (an increase of 25% over the previous year) this is less than anticipated due to the lower than expected sales of TruCCOMS, the reasons for which are set out below. TruCCOMS Although the marketing of TruCCOMS continued in the USA and Europe, during the latter part of the financial year we responded to feedback from customers on the TruCCOMS monitor and as a result made adjustments to the monitor software. These adjustments were only possible subsequent to sales and feedback from customers and therefore this resulted in lower than anticipated sales during the financial year. With changes to this software now implemented and available in the market place, feedback from customers is positive and the Directors are confident that our continued marketing efforts will lead to enhanced sales during the current financial year. Initially, our monitors were placed in 85 centres in Europe and 28 centres in the USA. Approximately 160 monitors have now been updated with revised software with 33 hospitals in Europe adopting the TruCCOMS system from the 52 hospitals currently evaluating it. In addition, in the USA, a further 15 centres are evaluating the system. The focus of our marketing and sales efforts is directed at surgical physicians and anaesthetists (being the personnel involved in the care of patients whilst in operating theatres) in numerous cardiac hospitals with the system being used in particular in 'off-pump surgery'. This involves the patient relying on his/ her own heart and lung activity during surgery rather than on an external mechanical pump. Independent Data (IMS 2000 Data; Society of Critical Medicine, 2000 Data; US Government Health Cost and Utilisation Statistics, 2001) anticipates increased use of 'off-pump surgery' in the USA (where currently 20% of all Coronary Artery Bypass Surgery ('CABG') procedures are performed 'off-pump') to the extent that it is anticipated that 40% to 50% of all CABG procedures performed in the USA over the next four to five years will be 'off-pump'. 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. In addition we announced on 24 May 2002 that we had entered into a sub-contract agreement with BD for the manufacture of TruCCOMS catheters at BD's plant in Singapore. As a result, the Directors anticipate that there will be a significant reduction in the cost base of our Critical Care business. It is regrettable however that following this rationalisation a number of our employees in Scotland have been made redundant. These steps were however, deemed necessary in order to increase our competitiveness and improve the performance of the Group. New Tri-leaflet Heart Valve The regulatory testing phase of our new tri-leaflet heart valve commenced in early October 2001 and represents the next phase of testing in order to meet the requirements of both European Regulators and the FDA in the USA prior to commencing clinical trials with the heart valves in patients. On 29 May 2002 we announced performance issues in respect of testing of our valves in the regulatory phase. Although earlier results from a number of our valves show excellent performance and meet initial expectations there will be a delay in our clinical trials in patients because of performance issues relating to these valves. A further announcement will be made when all the relevant tests are completed and evaluated during the course of the next few months. Previous attempts to develop a new synthetic tri-leaflet heart valve were based on using polyurethane materials which, although they had good mechanical properties, did not exhibit the level of biostability required for use in a heart valve. The Elast-eon material which forms the basis of AorTech's synthetic tri-leaflet heart valve has demonstrated the appropriate mechanical properties and greater biostability than traditional polyurethanes during the development phase over several years and, as a result of this successful phase, we commenced the regulatory phase testing in October 2001. Elast-eon Material Although the focus of the Elast-eon material has been to provide the necessary material for the tri-leaflet heart valve there are other potential uses for the material in implantable medical devices. There are ongoing Material Evaluation Agreements with a number of medical device companies and there have been two Material Evaluation Agreements which have resulted in Licence Agreements - one with JOMED to utilise the material for stent application and one with Sunshine Heart to utilise the material in cardiac assist devices. Stents are support devices used frequently after angioplasty, a method which is used to eliminate the narrowing of blood vessels, stents supporting and maintaining the opening of the blood vessels. Reuters have reported that Wall Street analysts forecast that the market for this business is expected to grow to approximately US$5 billion over the next few years. Sunshine Heart has developed a fully implantable peri-aortic balloon device to provide long-term relief and recovery for patients from chronic heart failure. Whilst conventional medical and invasive surgical approaches are the current practice in the treatment of heart failure and disease, the Directors believe there is clinical need for devices which are more efficient at improving heart function to avoid the costs and complications of ventricular assist devices. It is AorTech's intention to review other opportunities for the use of Elast-eon in the development of stents and ventricular assist devices. We have recently taken steps to rationalise and restructure our organisation in Australia with the intention of locating our operations within one facility in Melbourne. Future Prospects Although the Company has made continued progress in the development of our technologies I, together with the Directors, share the disappointment of our shareholders with the performance of our share price in what have been difficult market conditions for many technology stocks. Although delays in both our clinical trials and sales of our TruCCOMS system have been experienced, the Group is now moving from being focused on the development of innovative technologies to their commercial exploitation. With the support of the Board, I have continued to make the necessary changes to strengthen the Senior Management of the Company to ensure the success of this commercialisation programme. I take this opportunity of thanking our Directors and employees of the Group for their commitment and contribution towards the changes which have been implemented during a difficult year, and which has enabled a platform to be put in place to ensure a promising future for our company. E. McDaid Joint Chairman & Chief Executive 28 June 2002 CONSOLIDATED PROFIT AND LOSS ACCOUNT restated Year Ended Year ended Note 31 March 2002 31 March 2001 £ £ Turnover 1 4,626,955 3,701,365 Cost of sales (2,555,856) (1,667,653) Gross profit 2,071,099 2,033,712 Selling and marketing costs (2,863,689) (1,065,257) Administrative expenses (13,022,661) (7,953,999) Administrative expenses include: Development expenditure (6,811,308) (4,626,361) Amortisation of intangible fixed assets (1,247,469) (1,227,586) Costs incurred on proposed acquisition (1,267,474) - Loss on operating activities before interest (13,815,251) (6,985,544) Interest receivable 931,594 785,838 Interest payable - (25,755) Loss on ordinary activities before and after taxation (12,883,657) (6,225,461) Loss per ordinary share 2 Basic (34.69p) (20.75p) Diluted (34.69p) (20.75p) Statement of Total Recognised Losses Loss for the financial year (12,883,657) (6,225,461) Currency translation differences arising on consolidation (47,487) (211,990) Total recognised losses relating to the year (12,931,144) (6,437,451) Prior year adjustment 3 (53,487) Total losses recognised since last annual report (12,984,631) CONSOLIDATED BALANCE SHEET restated 2002 2001 £ £ Fixed Assets Intangible Assets 21,075,294 22,137,882 Tangible Assets 4,828,832 2,535,126 25,904,126 24,673,008 Current Assets Stocks 3,992,311 2,634,303 Debtors 2,381,808 2,846,994 Cash at Bank 16,558,880 8,325,970 22,932,999 13,807,267 Creditors: amounts falling due within one year (2,508,234) (2,377,592) Net Current Assets 20,424,765 11,429,675 Total Assets less Current Liabilities 46,328,891 36,102,683 Deferred Income (120,072) (139,734) Net Assets 46,208,819 35,962,949 Capital and Reserves Called Up Share Capital 9,525,696 7,547,341 Share Premium Account 63,359,593 42,160,934 Other Reserve (2,003,143) (2,003,143) Profit and Loss Account (24,673,327) (11,742,183) Equity Shareholders' Funds 46,208,819 35,962,949 CONSOLIDATED CASH FLOW STATEMENT restated 2002 2001 £ £ Net cash outflow from operating activities (13,821,019) (5,096,432) Returns on investment and servicing of finance 832,425 812,130 Capital expenditure and financial investment (2,982,325) (1,917,169) Cash outflow before management of liquid resources and financing (15,970,919) (6,201,471) Management of liquid resources (8,335,126) 7,831,938 Financing 24,186,714 (1,461,733) (Decrease)/increase in cash in year (119,331) 168,734 NOTES Note 1 Segmental analysis by class of business and geographical area (a) Class of business The Group operates in one class of business (b) Geographical area The analysis by geographical area of the Group's turnover is set out below: restated 2002 2001 Destination Origin Destination Origin £ £ £ £ Geographical segment United Kingdom 1,170,269 3,541,413 888,922 2,878,834 Rest of Europe 2,918,684 818,863 2,686,888 726,399 Rest of World 538,002 266,679 125,555 96,132 4,626,955 4,626,955 3,701,365 3,701,365 Note 2 Loss per ordinary share The basic loss per ordinary share is calculated on the loss of the group of £12,883,657 (restated 2001 - £6,225,461) and on 37,137,110 (2001 - 29,999,033) equity shares. Note 3 Prior Year Adjustments During the year, the Company changed its policy with regard to revenue recognition. Previously, revenue was recognised in respect of bill and hold sales where customers are invoiced for goods but the Company continues to hold them. Revenue was recognised in such transactions on invoicing rather than delivery to customers. Under the new accounting policy, revenue is recognised only when goods are invoiced and shipped to customers. The effect of this change in accounting policy on the current year was to decrease sales by £82,197 (2001: £349,220), to decrease cost of sales by £10,236 (2001: £336,833) and to increase the loss for the year by £71,961 (2001: £12,837). The change of policy reduced shareholders' funds by £53,487 as at 1 April 2001. This information is provided by RNS The company news service from the London Stock Exchange
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