Interim Results - 6 Months to 30 September 1999

Aortech International PLC 15 December 1999 Interim Results for the Six Months Ended 30 September 1999 AorTech International plc, the Scottish-based manufacturer of cardio-vascular devices, announces its Interim Results for the six months ended 30 September 1999. The Company continues to achieve its objectives and has made significant progress in the past six months. Highlights * Turnover increased 30% to £1.62 million; Loss for the period reduced to £110,445 * Tissue valve business acquired * TruCOMMS FDA approval secured * Additional evaluation agreements for Elast-eon signed * Trileaflet heart valve design completed * Funds in place to meet current working capital requirements Gordon Wright, Chairman, commented: 'A sharp increase in sales of Tissuemed heart valves contributed to the overall increase in sales and we anticipate further growth during the remainder of the current financial year. Sales of the Mitral Repair System have been very encouraging and the manufacturing agreement with Novoste Inc continues to provide a valuable source of revenue. 'The last six months has been a period of progress, growth and continued development of AorTech and your Directors expect that the next twelve months will produce further significant opportunities. 'We are particularly excited about the continued good results from our trileaflet heart valve development and look forward to the commencement of clinical trials in patients in 2001.' 15th December 1999 ENQUIRIES: AorTech International plc Tel: 01698 746699 Eddie McDaid, Managing Director Bell Lawrie White & Co. Tel: 0141 221 7733 Clive Thomson / Elizabeth Kennedy College Hill Tel: 0171 457 2020 Michael Padley / Nicholas Nelson CHAIRMAN'S AND MANAGING DIRECTOR'S STATEMENT The six month period has seen truly significant advances in all of AorTech's main activities and we are particularly pleased that the long term significance of these achievements is increasingly being recognised by investors. The value that the Market is now placing upon AorTech is a tangible endorsement of the Directors' confidence in the Company's excellent prospects in the global medical device market. The highlights of this period have been: * Acquisition of the tissue valve manufacturing business and related patents of Tissuemed Limited. * Conclusion of agreements to secure ownership of the intellectual property for the innovative TruCCOMS cardiac monitoring system. * FDA regulatory approval for TruCCOMS, allowing marketing in the USA. * Completion of the design for the new synthetic trileaflet heart valve. * Durability tests on the trileaflet valve passing 300 million cycles (equivalent to 7.5 years in patients). * Further evaluation agreements for Elast-eon biomaterials entered into by Elastomedic. Results for the Period and Financial Position We are pleased to report a further increase in the Company's turnover for the six month period to 30 September 1999 to £1,619,266 which represents an increase of approximately 30% over the same period last year. The pre tax loss of £110,000 represents a significant decrease, of approximately £165,000, compared to the same period last year. This is a result of increased sales and improvement in gross margins. A sharp increase in sales of Tissuemed heart valves contributed to the overall increase in sales and we anticipate further growth during the remainder of the current financial year following the recent acquisition of this business. During the period, AorTech concluded a distribution deal with MEDOS in Germany for both Tissuemed and Ultracor valves. Sales of the Mitral Repair System have been very encouraging and the manufacturing agreement with Novoste Inc continues to provide a valuable source of revenue and recognition of the Company's manufacturing and quality control procedures. It is anticipated that the turnover for the six month period to 31 March 2000 will show further growth over the period to 30 September 1999. As at 30 September 1999 the Company had cash resources in excess of £2 million. These resources are sufficient to complete the initial commercialisation of the TruCCOMS system and to meet our current working capital requirements. Tissuemed On 1 September 1999, the Company acquired the heart valve division of Tissuemed Limited for £800,000 in cash with a further £200,000 deferred consideration related to performance. This was partly funded by a Placing of 141,000 shares which raised £500,000. Prior to this acquisition, the Company had exclusive worldwide distribution rights in respect of Tissuemed's heart valves. The acquisition means that AorTech now has ownership of a range of both mechanical and tissue heart valve replacements. The tissue valve market is showing significantly more growth than the mechanical valve market and this acquisition ensures that AorTech is well placed to take advantage of this growth. TruCCOMS On 30 July 1999 we announced that we had concluded agreements to secure rights to the intellectual property, including the USA patents for the innovative TruCCOMS cardiac monitoring system. In our view this system represents a major breakthrough in the monitoring of patients' cardiac output both during and after surgery. The system, which consists of a disposable catheter linked to an analytical and display monitor, provides an immediate response and continuous monitoring of cardiac output and addresses shortcomings in current clinical assessment technology during surgical procedures and in intensive care. Development work has been carried out and completed during the last 21 months and the first phase of clinical trials in Papworth Hospital in England confirmed the accuracy and immediate response of the system. Market enquiries indicate that TruCCOMS will provide improved patient management information, which is not currently available to surgeons, anesthetists, cardiologists and critical care specialists. The final phase of clinical trials of TruCCOMS commenced in mid-September and should be concluded in the early part of 2000. On 4 November 1999, we announced that US regulatory approval had been obtained for TruCCOMS. The achievement of the Food & Drug Administration approval allows us to market the system in the USA and the Directors anticipate that the technology will be ready to enter intensive care units and operating theatres during the first quarter of the year 2000. European regulatory approval is anticipated during the early part of next year. We believe that the present worldwide thermal dilution catheter market of approximately US$200 million per annum will increase with the introduction of our new system. It is intended to manufacture TruCCOMS at the Company's facility in Scotland. AORTECH INTERNATIONAL PLC Interim results for the six months ended September 1999 The acquisition of the intellectual property together with the development of TruCCOMS to date through to clinical trials represents a major breakthrough by the Company. TruCCOMS will, your Directors believe, continue to contribute towards real growth in shareholder value. A Placing which raised £2.88 million was concluded in August 1999. This raised funds to complete the acquisition of the TruCCOMS system, finalise the development and clinical trials of the system and for its initial commercialisation. New Synthetic Trileaflet Heart Valve Our new synthetic trileaflet heart valve is considered by the Directors to represent the major development in heart valve replacement during the last 25 years. The purpose of this new valve is to overcome the major problems of all current replacement heart valves namely the requirement of patients to take daily anti-coagulants in the case of mechanical valves and the relatively short life span (6-10 years) of tissue valves. We are pleased to confirm that the design of the new synthetic trileaflet heart valve has been completed and that full patent filings in all countries considered strategically important by the Directors were made in June 1999. The design of the new valve has met all key tests to date and continuous simulated durability trials are still progressing. Our valves have already achieved critical durability levels of 300 million cycles in testing, representing 7.5 years in patients. Home Office approval has been granted for the first phase of in-vivo testing of the valves and this has now commenced with valves being implanted in sheep in November 1999. There are further milestones to be passed relating to the long term durability and the final results of biostability and biocompatability in these animal trials. All of the results to date give your Directors confidence that the final development phase for this product will result in a new generation of replacement heart valves suitable for clinical trials in patients during 2001. The Directors are aware that major medical device companies in the US have, over a number of years, sought to develop a new synthetic heart valve to overcome the current problems of mechanical valves and tissue valves. We believe, therefore, that the commencement of clinical trials in patients in respect of our new valve should have a significant effect on the share value and market capitalisation of the Company. Elastomedic The decision both to invest in Elastomedic and to obtain exclusive worldwide rights to the new biomaterials for use in the synthetic trileaflet heart valve has been fully justified by the exciting results being achieved. In addition, Elastomedic has concluded evaluation agreements with twelve major corporations for use of the material in other medical devices. The use of the materials in medical device applications other than heart valves provides, the Directors believe, opportunities for major growth not only for Elastomedic but also for AorTech through its investment in that company. Future Prospects The acquisition and development of TruCCOMS, together with the continued development of the new trileaflet heart valve, demonstrates our determination not only to expand further our product base but also to introduce innovative products to the medical device market with, we believe, significant profit potential. Obtaining regulatory approval for TruCCOMS together with the commencement of sales of this product will have a substantial benefit on the long term future growth of AorTech. We are particularly excited about the continued good results from our trileaflet heart valve development and we look forward to the progress of this project during the course of the next twelve months and to the commencement of clinical trials in patients in 2001. The Directors believe that this will have a further significant impact on the performance and future prospects of the Company. Given the Company's prospects and plans for growth, the Directors are examining the merits of a range of stockmarkets on which the Company's shares might be traded. These include the Official List, with the option of joining techMARK, and NASDAQ in the USA. The continued development and progress of AorTech has been the result of dedication and commitment by all of the Company's employees, our University partners in the United Kingdom and our colleagues in Australia. We take this opportunity to thank all of our team for their outstanding contribution and also to thank our shareholders for their continued support. The last six months has been a period of progress, growth and continued development of AorTech and your Directors expect that the next twelve months will produce further significant opportunities and growth prospects for your Company. J G Wright, Chairman E McDaid, Managing Director 15 December 1999 CONSOLIDATE PROFIT AND LOSS ACCOUNT (UNAUDITED) Six months ended Year ended 30 September 31March 1999 1998 1999 Note £ £ £ Turnover 2 1,619,266 1,250,435 2,779,315 Cost of sales (644,848) (640,736) (1,239,431) Gross profit 974,418 609,699 1,539,884 Net operating expenses (1,068,979) (901,300) (1,883,105) Loss on ordinary activities (94,561) (291,601) (343,221) before interest Interest receivable 11,068 48,656 83,385 Interest payable (26,952) (32,084) (60,748) Loss on ordinary activities before and after Taxation 2 (110,445) (275,029) (320,584) Loss per ordinary share 3 (0.5)p (1.4)p (1.6)p Statement of total recognised losses Loss for the period (110,445) (275,029) (320,584) Currency translation differences arising on (506) 634 (17) consolidation Total recognised losses (110,951) (274,395) (320,601) CONSOLIDATED BALANCE SHEET (UNAUDITED) 30 September 31 March 1999 1998 1999 £ £ £ Fixed assets Intangible assets 4,034,196 925,676 1,433,295 Tangible assets 1,014,959 772,169 1,040,170 Investment in associated 761,479 488,896 622,287 undertaking 5,810,634 2,186,741 3,095,752 Current assets Stocks 1,854,695 1,355,287 1,651,874 Debtors 1,298,400 1,103,548 1,155,550 Cash at bank 2,066,324 1,871,395 576,779 5,219,419 4,330,230 3,384,203 Creditors: amounts falling due (2,054,949) (906,141) (896,581) within one year Net current assets 3,164,470 3,424,089 2,487,622 Total assets less current 8,975,104 5,610,830 5,583,374 liabilities Creditors: amounts falling due (420,875) (478,391) (355,964) after more than one year Accruals and deferred income (287,681) (50,000) (199,169) Net assets 8,266,548 5,082,439 5,028,241 Capital and reserves Called up share capital 6,015,845 5,081,818 5,081,818 Share premium account 6,942,735 4,535,496 4,527,504 Other reserve (2,003,143)(2,003,143) (2,003,143) Profit and loss account (2,688,889)(2,531,732) (2,577,938) Shareholders' funds 8,266,548 5,082,439 5,028,241 AORTECH INTERNATIONAL PLC Interim results for the six months ended September 1999 CONSOLIDATED CASH FLOW STATEMENT (UNAUDITED) Six months ended 30 Year ended September 31 march 1999 1998 1999 Note £ £ £ Net cash outflow from (382,212) (447,333) (816,453) operating activities (see below) Returns on investment and (20,896) 16,572 20,763 servicing of finance Capital expenditure and (1,334,938) (822,648) (1,638,912) financial investment Cash outflow before (1,738,046) (1,253,409) (2,434,602) management of liquid resources and financing Management of liquid (1,341,478) (1,800,000) (495,064) resources Financing 3,227,591 2,757,871 2,642,943 Increase/(decrease) in cash 4 148,067 (295,538) (286,723) in the period Reconciliation of operating loss to net cash outflow from operating activities Continuing activities Operating loss (94,561) (291,601) (343,221) Amortisation of intangible fixed 21,870 15,019 30,147 assets Depreciation of tangible fixed 86,010 80,585 179,864 assets Gain on sale of tangible fixed (14,311) - - assets Release from deferred grants (25,000) - (30,435) Increase in stocks (202,821) (239,352) (535,939) Increase in trade debtors (19,770) (226,150) (352,885) Decrease/(increase) in 46,561 (83,482) (77,706) prepayments (Increase)/decrease in other (165,517) 166,833 235,397 debtors (Decrease)/increase in trade (67,298) 130,201 104,108 creditors Increase/(decrease) in other 4,451 (2,691) 8,175 taxes and social security Increase/(decrease) in accruals 48,174 3,305 (33,958) Net cash outflow from operating (382,212) (447,333) (816,453) activities NOTES 1. Basis of preparation These unaudited interim financial statements have been prepared on the basis of the accounting policies set out in the Group's annual report for the year ended the 31 March 1999. The financial information contained in these interim financial statements does not constitute statutory accounts within the meaning of section 240 of the companies Act 1985. The financial information for the year ended the 31 March 1999 is an extract from the latest published financial statements that have been delivered to the registrar of companies and on which the auditors' report was unqualified. 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 The analysis by geographical area of the group's turnover, loss before tax and net assets is set out below: (i) turnover Six months Six months Year ended ended ended 31 March 1999 30 September 30 September 1999 1998 Sales by Sales Sales by Sales Sales by Sales destina- by destina- by destina- by tion origin tion origin tion origin £ £ £ £ £ £ Geographical segment United 284,587 1,380,665 304,239 991,245 997,817 2,289,097 Kingdom Rest of 1,313,918 238,601 871,176 259,190 1,746,693 490,218 Europe Rest of 20,761 - 75,020 - 34,805 - World 1,619,266 1,619,266 1,250,435 1,250,435 2,779,315 2,779,315 (ii) loss before tax Six months Six months Year ended ended ended 31 March 30 September 30 September 1999 1999 1998 £ £ £ Geographical segment United Kingdom (96,996) (295,880) (347,743) Rest of Europe 2,435 4,279 4,522 Loss before interest (94,561) (291,601) (343,221) Net interest (15,884) 16,572 22,637 (payable)/receivable (110,445) (275,029) (320,584) (iii) net assets 30 30 31 March September September 1999 1999 1998 £ £ £ Geographical segment United Kingdom 8,060,933 4,927,438 4,863,194 Rest of Europe 205,615 155,001 165,047 8,266,548 5,082,439 5,028,241 1. Loss per ordinary share The basic loss per ordinary share is calculated on the loss of the group of £110,445 for the six months to 30 September 1999 ( six months ended 30 September 1998: £275,029 year ended 31 March 1999: £320,584) and on the following number of shares: a 21,031,041 equity shares being the weighted average number of shares in issue during the six months ended the 30 September 1999 after the issue of an additional 3,595,106 new ordinary shares on the 27 August 1999 and an additional 141,000 new ordinary shares on 10 September 1999 b 19,267,759 equity shares being weighted average number of shares in issue during the six months ended 30 September 1998 c 19,833,420 equity shares being the weighted average number of shares in issue during the year ended 31 March 1999 1 .Analysis of net funds 1st April Cash Non-cash 30 September 1999 flow changes 1999 £ £ £ £ Net Cash: Cash at bank and in 576,779 1,489,545 - 2,066,324 hand Deposits treated as (495,064) (1,341,478) - (1,836,542) liquid resources 81,715 148,067 - 229,782 Liquid resources: Deposits included in 495,064 1,341,478 - 1,836,542 cash Debt: Debt due within one (168,912) 121,667 (90,089) (137,334) year Debt due after more (355,964) - 90,089 (265,875) than one year (524,876) 121,667 - (403,209) Net Funds 51,903 1,611,212 - 1,663,115 1. Millennium Compliance The company has completed the upgrading and testing of all its systems and the Board believes that all reasonable and appropriate measures have been taken to avoid commercial disruption. Copies of this statement will be posted to shareholders and will be available for a period of 14 days from the Company's registered office: Phoenix Crescent, Strathclyde Business Park, Bellshill, Scotland ML4 3NU.
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