Final Results

NMT Group PLC 8 May 2002 NMT Group PLC Preliminary results for the year ended 31 December 2001 NMT Group PLC ('NMT'), the safety syringe manufacturer, today announces its preliminary results for the year ended 31 December 2001. 2001 Highlights • High volume 3cc production capability now in place • 1cc syringe now available in commercial quantities • Sales and marketing team in key US market significantly strengthened • £24.2m fundraising successfully completed in December 2001 • Turnover increased to £1.1m (2000:£0.4m); pre-tax loss of £13.3m (2000:£13.2m) • Strong balance sheet with cash balances of £26.7m at period end (2000: £19.9m) Commenting on the results, Roger Gilmour, Chairman of NMT, said: 'With the resolution of the first generation manufacturing problems, second generation syringe development well advanced, a strong balance sheet and a broad range of commercial opportunities ahead, we are encouraged by the progress achieved since the December 2001 fundraising.' Enquiries NMT Group PLC Today: 020 7831 3113 Roy Smith, Chief Executive Thereafter: 02380 646783 Gerard Cassels, Group Finance Director Thereafter: 01506 445004 Financial Dynamics Tel: 020 7831 3113 Fiona Noblet 2001 was a year of fundamental change within NMT. The positive impact of the initial change programmes launched by the new management team started to be realised and substantially improved the position of the Group. During the year, the manufacturing team progressively demonstrated the capability to consistently produce high quality safety syringes in commercial quantities. The sales and marketing organisation in the US was re-focused and, as commercial production became available, significantly strengthened. In December 2001 £24.2m (net of expenses) was raised to provide further working capital, additional 1cc manufacturing capacity, and sufficient funds to develop a 'second generation' of safety syringe products, providing in particular greater flexibility for the user to switch between needle sizes. Turnover for the year increased to £1.1m from £0.4m in 2000. The loss for 2001 of £13.3m was similar to the £13.2m in 2000. As a result of the fundraising discussed above, the balance sheet remained strong with cash balances of £26.7m (2000 £19.9m) at the end of the year. Although sales in 2002 to date are significantly greater than the same period last year, sales volumes have been below expectations. Utilisation of safety syringes and our own sales growth within the US acute care market has been slower than anticipated. The directors believe this shortfall has been largely due to the delayed impact of the Needlestick Safety and Prevention Act on hospital procurement practices. However, this has been partially offset by progress in the alternate care market. In addition, the Group is actively pursuing opportunities within the pharmaceutical sector as a means to further accelerate our sales growth. In particular, I am encouraged by discussions with a global pharmaceutical company, which are at an advanced stage and, if successfully concluded, offer a material opportunity for the Group. In parallel to developing our brand equity strategy, the Group is considering additional commercial opportunities with several leading medical device organisations. These companies have expressed an interest in distributing our products in certain strategic markets where they have significant sales and marketing infrastructures. Design for the manufacture of second generation syringes is progressing well with 1cc pilot tooling being manufactured. The new design will both provide enhanced performance features and deliver significant unit cost savings compared to our existing fixed needle syringes. The Group is close to selecting a partner, experienced in the manufacture of medical devices, to outsource the production of second generation syringes. The short list candidates have worldwide manufacturing locations and specialise in the assembly of small, technically challenging, precision components, which must meet stringent accuracy, quality and finishing standards. Brian Scanlon resigned as a non-executive director on 31 January 2002 due to additional commitments arising from a post with Hewitt Associates LLC of Houston, Texas. I wish him well in the demanding environment of business practice development in the US and thank him for his support and counsel over the years. With the resolution of first generation syringe manufacturing problems, second generation syringe development well advanced, a strong balance sheet, and a broad range of commercial opportunities, the directors are encouraged by the progress achieved since the December 2001 fundraising. R H Gilmour Chairman OPERATING REVIEW NMT's objective is to commercialise a range of safety devices based on the Group's patented needle retraction technology. This is being achieved primarily through the development of a portfolio of safety syringes, intellectual property, production capacity for the automated assembly of safety syringes and sales and marketing infrastructures in both the US and Europe. The Group's manufacturing facility is based in Livingston, Scotland, and contains four clean rooms, which house the Group's three Sortimat (3cc syringe) and one Mikron (1cc syringe) automated assembly machines. In addition, the manufacture of the Group's IV catheter has been outsourced to an experienced manufacturer of medical devices in India, Eastern Medikit Limited. The Group has established a dedicated US sales and marketing team which is now based near Boston, Massachusetts, and a European sales office located in the south of England. In the last year, the Group has made significant advances towards establishing the necessary platform to achieve commercial viability for the Group's operations, namely: • developing a high volume production capability for the 3cc syringe; • commencing the manufacture of commercially saleable quantities of 1cc syringes; • continuing to develop a second generation syringe design which allows simplification of syringe assembly; • adding a safety IV catheter to the Group's product range; and • rebuilding the Group's US sales and marketing operations, with the establishment of a dedicated sales force and securing a number of key US agreements to provide access to further potential customers. Production During 2001 the Group achieved continuous improvement in its ability to manufacture both 3cc and 1cc syringes. This was particularly evident during the final quarter when the Group achieved consistent levels of production. This is the result of the significant effort and resources put in by the operations team at Livingston. Following a re-design, based on experience gained from the Group's previous assembly lines, Sortimat 3 was successfully commissioned within 6 weeks of delivery in June 2001. The engineering and design features which have been incorporated into Sortimat 3 are now used as the Group's standard for the existing 3cc Sortimat machines and Sortimat 2 was appropriately upgraded by the year-end. The Group took delivery of a syringe assembly machine to manufacture 1cc safety syringes from Mikron SA in October 2000. As was experienced with the Sortimat 2 machine, the Mikron machine suffered a number of operational problems upon start-up and a continuous improvement programme has been developed between Mikron SA and the Group which showed considerable progress in the latter stages of the year and is expected to continue to provide further improvement in both output and yield in 2002. An ongoing comprehensive multi-cavity tooling programme was implemented by the Group during 2001 for both 1cc and 3cc safety syringe components with the aims of reducing material costs and providing sufficient component manufacturing capacity to match assembly requirements. The first deliveries of the outsourced IV safety catheters for initial clinical field trials were made in November 2001, followed by commercial sales orders in early 2002. Product Development The principal production challenges faced by the Group in relation to 3cc and subsequently 1cc safety syringes arose due to the number of component parts involved and the complexities of and the stringent tolerances used within the high speed automated assembly process. To address these issues, significant design work has been carried out by the Group utilising moulding technology used in other industries and the considerable experience that has been gained in commissioning existing assembly lines. As a result of this, the directors believe that the Group now has design solutions to optimise the manufacturing process and thereby reduce the cost of production. Furthermore, to maintain its competitive position, the Group recognises the need to develop a 'second generation' of safety syringe products providing greater flexibility for the user to switch between needle sizes. Work on this project has been undertaken in tandem with the new 1cc assembly line. Sales and Marketing - United States The Group's sales and marketing efforts for its safety syringes are concentrated principally in the US, which the directors believe is currently the largest market for safety syringes. The use of safe needle technology is mandated throughout the whole of the US through the Needlestick Safety and Prevention Act, which came into effect in August 2001. Following a review of its US operation in the spring of 2001, the Group has: • relocated its US sales and marketing operating from Indiana to Massachusetts in order to capitalise on the concentration of medical devise expertise based in the north-eastern seaboard; • rebuilt its US sales and marketing operations which now include sixteen specialist account managers covering the major US territories. The majority of these people have been recruited since September 2001, when production issues had been largely resolved; • re-focused its sales and marketing efforts to target group-purchasing organisations, proprietary purchasers and integrated healthcare delivery networks. The agreements already entered into with such bodies enable hospitals and other purchasers to order the Group's products through these distributors; and • re-focused its efforts on the supply of its 1cc and 3cc syringes into the US market. Experience during the year, with larger potential customers in particular, has indicated that there are frequently delays between product evaluation, the awarding of contracts with distributors to enable purchasers to acquire the Group's products and the placement of orders. Furthermore, it became apparent during the year that certain of the Group's potential customers were unwilling to evaluate the Group's 3cc syringes due to the lack of an accompanying FDA approved 1cc insulin safety syringe in the Group's product portfolio. In November 2001, FDA approval for a 1cc insulin safety syringe was granted and from February 2002 the product has been available in commercial quantities, which should increase the opportunities for sales growth of the Group's 3cc syringes. In addition, the recent US federal needlestick legislation has, in the Group's experience, not yet been rigorously enforced. Sales & Marketing - Europe The directors believe that development of the European market for safety syringes is behind that of the US and, consequently, that this is not a key market today for the Group's safety syringe products. However, the Group has identified potential sales opportunities for an IV safety catheter for which clinical trials in the UK began in November 2001. The results are encouraging and three major distributors now stock the Group's catheters to provide a distribution conduit to all NHS trusts. Litigation In November 2001, the Group settled its outstanding patent dispute with Syringe Development Partners LLC and Medsafe Technologies LLC. The directors felt that settlement at this stage was in the best interests of the Group, as it would enable the directors to concentrate on its business at a key time for manufacturing scale-up and product roll out. FINANCIAL REVIEW Operating Results Turnover of £1.1m primarily consisted of sales for the USA and nearly tripled the 2000 figure of £0.4m, reflecting the expansion of 3cc syringe output and the start of 1cc production. Operating losses of £13.7m remained at a similar level to the £13.7m loss in 2000, but do not include any exceptional items (2000 - £3m). Net interest receivable of £0.4m resulted in a loss after tax of £13.3m (2000 - £13.2m). The loss per share of 5.2p reduced from 8.8p per share in 2000, as a result of an increase in the weighted average number of shares to 255m shares from 150.1m. This reflected the issue of 171.3m shares in 2000 and 637m shares on 20 December 2001. Financial Position and Cash Flow The Group's net cash at the end of the financial year was £26.7m, an increase of £6.8m for the period. Cash outflow from operating activities was £14.2m (2000 - £9.6m). The overall increase in net funds resulted from the proceeds of a share issue of £24.2m (net of expenses) during the year. Capital expenditure of £3.1m (2000 - £2.5m) continued to reflect the build-up in manufacturing capacity with the purchase of automated assembly equipment and associated component tooling. Taxation No tax charge arose for the current year due to trading losses incurred. The Company has significant unutilised tax trading losses available to carry forward against future profits. Consolidated Profit and Loss Account For the year ended 31 December 2001 2001 2000 £'000 £'000 Turnover 1,136 441 Cost of sales (7,880) (5,070) _____ _____ Gross loss (6,744) (4,629) Distribution costs (3,046) (2,339) _____ _____ Administrative expenses (4,100) (3,708) Exceptional administrative expenses - (3,030) _____ _____ Total administrative expenses (4,100) (6,738) Other operating income 200 - _____ _____ Operating loss (13,690) (13,706) Interest receivable and similar income 552 733 Interest payable and similar charges (168) (254) _____ _____ Loss on ordinary activities before and after tax (13,306) (13,227) _____ _____ Loss per ordinary share Basic and diluted (5.2)p (8.8)p _____ _____ The above results relate to continuing operations. There is no difference between the loss on ordinary activities and the retained loss for the period stated above and their historical cost equivalents. Balance Sheets At 31 December 2001 Group Company 2001 2000 2001 2000 £'000 £'000 £'000 £'000 Fixed assets _____ _____ _____ _____ Tangible assets 11,532 9,940 11,521 9,940 _____ _____ _____ _____ Current assets Stocks 2,621 960 1,679 935 Debtors 640 729 8,643 5,306 Cash at bank and in hand 26,740 19,930 26,561 19,867 _____ _____ _____ _____ 30,001 21,619 36,883 26,108 Creditors: amounts falling due within one year (2,720) (3,328) (2,573) (3,173) _____ _____ _____ _____ Net current assets 27,281 18,291 34,310 22,935 _____ _____ _____ _____ Total assets less current liabilities 38,813 28,231 45,831 32,875 _____ _____ _____ _____ Creditors: amounts falling due after more than one year (1,088) (1,661) (1,088) (1,661) _____ _____ _____ _____ Net assets 37,725 26,570 44,743 31,214 _____ _____ _____ _____ Capital and reserves Called up share capital 37,187 11,708 37,187 11,708 Share premium account 38,639 39,949 38,639 39,949 Profit and loss account (38,101) (25,087) (31,083) (20,443) _____ _____ _____ _____ Total shareholders' equity funds 37,725 26,570 44,743 31,214 _____ _____ _____ _____ The financial statements were approved by the Board of Directors on 7 May 2002. Statement of Total Recognised Gains and Losses For the year ended 31 December 2001 Group 2001 2000 £'000 £'000 Loss on ordinary activities before and after tax (13,306) (13,227) Exchange adjustment on translation of investment in (100) (41) subsidiary _____ _____ Total recognised losses for the year (13,406) (13,268) _____ _____ Reconciliation of Shareholders' Funds For the year ended 31 December 2001 Group Company 2001 2000 2001 2000 £'000 £'000 £'000 £000 Total losses relating to the year (13,406) (13,268) (11,032) (10,744) Placing and Open Offer - shares issued 24,169 24,117 24,169 24,117 Share options - exercised - 614 - 614 - notional cost of share options granted 392 440 392 440 _____ _____ _____ _____ Total movements during the year 11,155 11,903 13,529 14,427 Shareholders' funds at 1 January 26,570 14,667 31,214 16,787 _____ _____ _____ _____ Equity shareholders' funds at 31 December 37,725 26,570 44,743 31,214 _____ _____ _____ _____ Consolidated Cash Flow Statement For the year ended 31 December 2001 2001 2000 Note £'000 £'000 Net cash outflow from operating activities 3 (14,171) (9,632) _____ _____ Returns on investments and servicing of finance Interest received 618 697 Interest paid (168) (254) _____ _____ Net cash inflow from returns on investments and servicing of finance 450 443 _____ _____ Capital expenditure and financial investment Purchase of tangible fixed assets (3,096) (2,523) Cash outflow before management of liquid resources and financing (16,817) (11,712) _____ _____ Management of liquid resources Cash placed on term deposit (5,566) (11,934) Financing Term loan repaid - (1,500) Finance lease - repayment of principal (542) (457) Proceeds on issue of shares 25,479 26,079 Expenses of share issue (1,310) (1,348) _____ _____ Net cash inflow from financing 23,627 22,774 _____ _____ Increase/(decrease) in cash in the year 4 1,244 (872) _____ _____ Notes to the Accounts 1. Accounting Policies Basis of preparation The financial statements have been prepared under the historical cost convention and in accordance with applicable accounting standards and on the basis of the accounting policies set out in the NMT Group PLC Annual Report 2000. 2. Financial Information The financial information set out in this announcement does not constitute the Group's statutory accounts, within the meaning of Section 240 of the Companies Act 1985, for the years ended 31 December 2001 or 31 December 2000, but is derived from those accounts. Statutory accounts for 2000 have been delivered to the Registrar of Companies, and those for 2001 will be delivered following the Company's Annual General Meeting. The auditors have reported on those accounts and their reports were unqualified and did not contain statements under section 237 (2) or (3) of the Companies Act 1985. 3. Reconciliation of operating loss to net cash out flow from operating activities 2001 2000 £'000 £'000 Operating loss (13,690) (13,706) Loss on disposal of fixed assets - 41 Impairment of intangible fixed assets - 1,731 Depreciation of intangible fixed assets - 79 Depreciation of tangible fixed assets 1,504 986 Exchange adjustments (100) (41) Share options - cost of share options granted 392 440 Increase in stock (1,661) (440) Decrease in debtors 23 49 (Decrease)/increase in creditors (639) 1,229 _____ _____ Net cash outflow from operating activities (14,171) (9,632) _____ _____ 4 Reconciliation of net cash flow to movement in net funds 2001 2000 £'000 £'000 Increase/(decrease) in cash in the year 1,244 (872) Term loan (drawn)/repaid - 1,500 Finance lease additions - (1,572) Cash flow from finance leases - repayment of principal 542 457 Cash inflow from increase in liquid resources 5,566 11,934 _____ _____ Change in net funds resulting from cash flows and movement in net debt in 7,352 11,447 the year Net funds at 1 January 2001 (note 5) 17,725 6,278 _____ _____ Net funds at 31 December 2001 (note 5) 25,077 17,725 _____ _____ 5 Analysis of net funds 2000 Cash flow Other 2001 non-cash changes £'000 £'000 £'000 £'000 Cash at bank and in hand 19,930 6,810 - 26,740 _____ _____ _____ _____ Finance lease due within one year (544) 542 (573) (575) Finance lease due after 1 year (1,661) - 573 (1,088) _____ _____ _____ _____ 17,725 7,352 - 25,077 _____ _____ _____ _____ This information is provided by RNS The company news service from the London Stock Exchange
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