Interim Results

Aortech International PLC 21 December 2004 For Immediate Release 21 December 2004 AorTech International plc ('AorTech' or 'the Company') Interim Results for the six months ended 30 September 2004 AorTech International plc, the biomaterials Intellectual Property and Material Manufacturing Company is pleased to announce its Interim Results for the six months ended 30 September 2004. Operational Highlights • Significant interest in Breast Implant technology • Dialogue commenced with potential licensees • Positive FDA meeting to discuss Beast Implant Testing Protocol • Progress with polymer heart valves Financial Highlights • Turnover on Continuing Operations £38,101 (2003: £212,414) • Group operating loss £947,786 (2003: £1,111,200) • Loss Before Taxation £838,262 (2003: £1,018,285) • Net cash of £5,030,227 (2003: £6,199,292) Commenting on the progress of the Company, Laurie Rostron, Non-Executive Chairman said: 'The interest in AorTech's breast implant technology has given the Board confidence to progress the development of the technology and to commence discussions with potential licensing partners. 'AorTech, as an early stage biomaterials company, now has a pipeline of applications, supported by strong intellectual property, which we are confident will create shareholder value in the medium term.' For further information please contact: AorTech International plc 020 7466 5000 (today) Laurie Rostron, Non-Executive Chairman 01698 746699 (thereafter) Frank Maguire, Chief Executive Buchanan Communications 020 7466 5000 Ben Willey, Lisa Baderoon, Rebecca Skye Dietrich Visit AorTech's website at: www.aortech.com Chairman's Statement Results For the six months ended 30th September 2004, the Company had a turnover of £38,101, operating costs of £976,958, down from £1,181,960 for the same period in the previous year, and a loss before taxation of £838,262 again down from £1,018,285 in the previous year. The cash position at £5,030,227 compares with £6,199,292 at the same time last year. These financial results reflect the early stage nature of the business but do not describe the significant progress that has been achieved during the period. Breast Implants Without doubt the progress on the development of the Elast-Eon breast implant has overshadowed all other activities to a point where it has become central to the future development strategy of the Company. As is often the case with early stage development companies, the change of strategy has been somewhat opportunistic and has accelerated as a consequence of the development of an alternative fill material for which new intellectual property has now been filed. It is the Directors' view that there is a significant latent demand from patients, surgeons and regulatory authorities for an alternative to the all silicone breast implant. In October we met, at our instigation, with the US Federal Drug Administration to discuss the baseline test results of Elast-Eon technology in accordance with the FDA 'Guidance for Breast Implants', a set of guidelines established to set the ground rules for the development of new breast implants. This meeting was positive, we received useful feedback on the calibre of our material testing data and afterwards the Board approved the proposal to move ahead with the development of the next generation of the breast implant device. Manufacturing processes are currently being defined and prototype devices have been produced. The Directors believe that an Elast-Eon breast implant will be significantly more reliable and safer than the existing saline or silicone filled implants. The technology has attracted the attention of the American Society of Aesthetic and Plastic Surgeons and the Company has received an invitation to present a paper on its next-generation breast implant at the upcoming Annual Society meeting in New Orleans in April 2005. The Company is currently in discussion with large potential industry partners, a number of whom have expressed significant interest although it is too early to finalise a license agreement. This remains a high risk project but the evidence is emerging that it could also have a high potential reward. Heart Valves AorTech's intellectual property position continued to improve when in October 2004, the European Patent Office granted patent 1006949B which is part of the Company's portfolio of polymer heart valve technology and includes surgical as well as percutaneous designs. In October 2004 the company received a positive opinion from the European Patent Office regarding the patentability of the claims made in the M 95 C patent application. During the past year, there has been significant industry investment in percutaneous heart valves for which the Company's M 95 C technology and intellectual property offers several advantages over existing technology. It is the Board's view that these events indicate that AorTech technology and intellectual property which is now of considerably more value than originally forecast. However, to date the Company has been unable to find a partner for this project. The Board believes that it is not in the shareholders interest to license this technology cheaply. Although this will take longer, the plan is to carry out further bench testing and pre-clinical trials in a manner that will support an FDA Investigational Device Exemption before the commencement of a full clinical trial on the valve. The Company will continue to seek a partner for this development project where the full value of the technology has a chance of being realised. Licensing and Supply The material licensing and supply activities, the now rather more routine part of the business, continue to make progress. The content of the FDA Master File has been increased and the first clinical use of Elast-Eon in a royalty bearing application is expected to occur in 2005. There are currently 5 active orthopaedic and 8 other long-term material applications under active evaluation with a partner. Whilst some of these appear tantalisingly close to completion, experience has shown that these business development cycles are by their nature, lengthy. Board Changes We announced at the end of October that Ian Cameron was stepping down from his position as Finance Director but would remain as a Non Executive Director and Company Secretary in the short term. Ian retired from the board with effect from 20th December 2004 to concentrate on his role as Finance Director at i-mate plc. I would like to thank Ian for his considerable contribution to the Company over the past 6 years and we wish him well in his new role. David Parsons, MA, ACIS has joined us as Company Secretary and Chief Financial Officer and I am delighted to welcome him to the team. Summary The Company' strategy is to develop the material license and supply component of the business to a point where the Company is profitable and then to increase shareholder value by identifying and developing selected devices through to the point of clinical trials. The Board believes that these selected device step outs from the material licensing have the potential to generate significant up-front, milestone and royalty income through partnerships with large medical device companies. The Elast-Eon breast implant is a prime example of the type of step outs that the Company is seeking and, although not with out risk, the Board is keen to maximise the Company's efforts to achieve this goal with this product. Laurie Rostron CONSOLIDATED PROFIT AND LOSS ACCOUNT (unaudited) Six months ended 30 Six months ended 30 Year ended 31 March September 2004 September 2003 2004 Note £ £ £ Turnover 2 38,101 212,414 360,185 Cost of sales (8,929) (141,654) (30,649) Gross profit 29,172 70,760 329,536 Selling and marketing costs (140,646) (111,408) (296,492) Administrative expenses (836,312) (1,070,552) (2,230,553) Administrative expenses include: Development expenditure (287,420) (161,088) (559,032) Amortisation of intangible fixed assets (46,427) (51,050) (97,863) Group operating loss (947,786) (1,111,200) (2,197,509) Exceptional items - - 552,856 Loss on ordinary activities before 2 (947,786) (1,111,200) (1,644,653) interest Interest receivable 109,524 92,915 195,096 Loss on ordinary activities before 2 (838,262) (1,018,285) (1,449,557) taxation Taxation 3 - 1,252,332 1,976,817 (Loss)/Profit for the financial period (838,262) 234,047 527,860 (Loss)/Profit per ordinary share 4 (22.00p) 6.14p 13.84p All of the turnover and operating losses are derived from continuing operations. Statement of total recognised (losses)/profits (Loss)/Profit for the financial period (838,262) 234,047 527,260 Currency translation differences (66,209) 250,406 130,024 arising on consolidation Total recognised (losses)/profits (904,471) 484,453 657,284 CONSOLIDATED BALANCE SHEET (unaudited) 30 September 2004 30 September 2003 31 March 2004 £ £ £ Fixed assets Intangible assets 1,474,060 1,684,640 1,565,806 Tangible assets 206,722 278,927 235,608 1,680,782 1,963,567 1,801,414 Current assets Stocks 50,744 - 48,853 Debtors 296,492 168,977 185,848 Cash at bank 5,030,227 6,199,292 5,968,200 5,377,463 6,368,269 6,202,901 Creditors: amounts falling due within (369,601) (668,552) (438,200) one year Net current assets 4,980,862 5,699,717 5,764,701 Total assets less current liabilities 6,661,644 7,663,284 7,566,115 Accruals and deferred income - (270,000) - Net assets 6,661,644 7,393,284 7,566,115 Capital and reserves Called up share capital 9,525,695 9,525,695 9,525,695 Share premium account 63,359,594 63,359,594 63,359,594 Other reserve (2,003,143) (2,003,143) (2,003,143) Profit and loss account (64,220,502) (63,488,862) (63,316,031) 6,661,644 7,393,284 7,566,115 CONSOLIDATED CASH FLOW STATEMENT (unaudited) Six months ended 30 Six months ended 30 Year ended 31 September 2004 September 2003 March 2004 Note £ £ £ Net cash outflow from operating activities Net cash outflow before exceptional (1,029,725) (850,772) (1,898,890) items Outflow related to exceptional items - (1,263,753) (1,335,862) Net cash outflow from operating (1,029,725) (2,114,525) (3,234,752) activities Returns on investment and servicing of 109,524 124,178 188,359 finance Taxation - 1,252,332 2,075,716 Capital expenditure and financial (11,374) 55,423 121,532 investment Disposals - - (50,000) Cash outflow before management of (931,575) (682,592) (899,145) liquid resources and financing Management of liquid resources 924,297 884,132 734,983 (Decrease)/Increase in cash in the 5 (7,278) 201,540 (164,162) period NOTES TO THE INTERIM FINANCIAL STATEMENTS (unaudited) FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2003 1 BASIS OF PREPARATION The interim financial statements have been prepared in accordance with the guidance published by the Accounting Standards Board and on the basis of the accounting policies set out in the Group's 2004 statutory accounts. The interim financial statements were approved by a duly appointed and authorised committee of the Board of Directors on 20 December 2004 and are unaudited. The information shown for the year ended 31 March 2004 does not constitute statutory accounts within the meaning of section 240 of the Companies Act 1985 and has been extracted from the full accounts for the year ended 31 March 2004 which have been filed with the Registrar of Companies. The report of the auditors on these accounts was unqualified and did not contain a statement under either section 237(2) or section 237(3) of the Companies Act 1985. 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: Six months ended 30 Six months ended 30 Year ended 31 March September 2004 September 2003 2004 Sales by Sales by Sales by Sales by Sales by Sales by destination origin destination origin destination origin (i) turnover £ £ £ Geographical segment United Kingdom - - - - - - Rest of Europe - - - - - - Rest of World 38,101 38,101 212,414 212,414 360,185 360,185 38,101 38,101 212,414 212,414 360,185 360,185 Six months ended 30 Six months ended 30 Year ended 31 September 2004 September 2003 March 2004 (ii) Profit/(loss) before £ £ £ tax Geographical segment United Kingdom (391,298) (830,269) (762,991) Rest of Europe - 26,471 (29,872) Rest of World (556,488) (307,402) (851,790) Loss before interest (947,786) (1,111,200) (1,644,653) Net interest receivable 109,524 92,915 195,096 Loss before taxation (838,262) (1,018,285) (1,449,557) 30 September 2004 30 September 2003 31 March 2004 (iii) net assets £ £ £ Geographical segment United Kingdom 4,772,111 5,189,669 5,534,686 Rest of Europe - 8,044 - Rest of World 1,889,533 2,195,571 2,031,429 6,661,644 7,393,284 7,566,115 3 TAXATION The taxation credit for the six months to 30 September 2003 and for the year to 31 March 2004 arose from cash received during the periods in respect of research and development credits. 4 (LOSS)/PROFIT PER ORDINARY SHARE The basic (loss)/profit per ordinary share is calculated on the loss of the Group of £838,262 for the six months to 30 September 2004 (six months ended 30 September 2003: profit £234,047, year ended 31 March 2004: profit £527,260) and on 3,810,278 (six months ended 30 September 2003: 3,810,278, year ended 31 March 2004: 3,810,278) equity shares, being the weighted average number of shares deemed to be in issue after adjusting for the ten for one share consolidation of 1 September 2003. 5 ANALYSIS OF NET FUNDS 1 April 2004 Cash flow Exchange 30 September differences 2004 £ £ £ £ Net cash Cash at bank and in hand 5,968,200 (931,575) (6,398) 5,030,227 Deposits treated as liquid (5,703,834) 924,297 - (4,779,537) resources 264,366 (7,278) (6,398) 250,690 Liquid resources Deposits included in cash 5,703,834 (924,297) - 4,779,537 Net funds 5,968,200 (931,575) (6,398) 5,030,227 This information is provided by RNS The company news service from the London Stock Exchange
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