Final Results - Year Ended 31 December 1999

NMT Group PLC 28 March 2000 NMT GROUP PLC Preliminary results for the year ended 31 December 1999 NMT Group PLC ('NMT'), the manufacturer of retractable devices to prevent needlestick injury, announces its preliminary results for the year ended 31 December 1999. Key Points -Additional US legislation introduced on the use of safety syringes -Increased focus on manufacturing scale-up and broadened product range -Second Sortimat assembly system installed -Successful Placing and Open Offer raised £15.3 million (net) in March 1999 -Second RSA Grant awarded Roy Smith, newly appointed Chief Executive Officer, commented: 'Legislation in the all-important US market has moved apace over the past year, strengthening our view that the safety syringe market presents a major commercial opportunity for NMT. We recognise and are addressing the need to expand our product range and to increase our manufacturing capability to meet the needs of our customers. We have ambitious plans to participate in this growing market and I firmly believe that we have the best technology to exploit it.' Enquiries: NMT Group PLC Today: 0207 831 3113 Roy Smith, Chief Executive Officer Thereafter: 01506 445000 Financial Dynamics Tel: 0207 831 3113 David Yates/Sophie Pender-Cudlip Chairman's Statement US regulation on the mandatory use of safety devices to prevent needlestick injury was introduced far earlier and more rapidly than the market had anticipated. This turned what was originally a market niche into a major market opportunity. As a result, there is a rapidly increasing demand for products such as NMT's safety syringe in a broader range of sizes. Our challenge has been to meet this demand and we are therefore working hard to address the needs of our customers through the expansion of our manufacturing capability and the broadening of our product range so that we can fully exploit this market opportunity as quickly as possible. During the year, John Campbell, the Chief Executive and one of the founders of NMT, resigned. John worked with the Company from its inception through to flotation and I would like to take this opportunity to thank him, on behalf of the Board, for his contribution to the Group. In January, we were pleased to announce the appointment of Roy Smith who was previously Chief Executive of the medical devices company, Advanced Medical Solutions plc and who prior to that, spent 16 years at Johnson & Johnson. He has a broad understanding of the medical devices market and, having worked extensively in the US, can bring to NMT knowledge and experience of commercialising technology and building brands in this market. Roy has been with the Company since the beginning of March and his initial impression is that the technology has enormous potential and that the market opportunity for NMT is a genuinely exciting one. However, he also recognises that the Company has a number of manufacturing challenges to address. He therefore intends to carry out a full operational review of the business and will present the results of his review, together with his plans for the Company going forward, at the Annual General Meeting on 11 May. Chief Executive's Review Operations During 1999, NMT concentrated on establishing and expanding its manufacturing base. The challenges faced during that year were typical of those faced by emerging manufacturing companies. However, we have always taken the view that having control of the assembly process in house would reduce our manufacturing risk and increase the potential return to shareholders. Not only is the assembly process a key value added step in the manufacture of NMT's safety syringes, it is also unique to our products. As a result, the assembly equipment, technical knowledge, and process know-how will prove invaluable to our future success. Whilst we experienced a number of difficulties with our first automatic assembly system, supplied by Sortimat Automations GmbH., we have applied that experience to the design of the second Sortimat machine, which was delivered towards the close of 1999. Production from the second Sortimat machine will be scaled up over a period of months and we are now confident of achieving an acceptable level of output. Furthermore, a third Sortimat machine, identical to the second, is due for delivery in the second quarter of this year alongside our first assembly machine for 1ml safety syringes. The 1ml assembly machine is being manufactured by Mikron SA of Switzerland which, like Sortimat, is a world- class manufacturer of assembly systems. Product Development The first Sortimat assembly machine is restricted to the supply of 3ml 25G x 5/8' safety syringes. Our customers have clearly indicated the need for a wider range and the second Sortimat machine will supply a broader range of 3ml syringes. However, initial production is concentrating on 23G x 1' and 21G x 1.5' safety syringes. Including the output from Sortimat 1, we will offer a good spectrum of subcutaneous, intramuscular and deep intramuscular injection devices. The third Sortimat machine, also capable of broadening the range of needle sizes on 3ml syringes, will further supplement this output. The Mikron system will supply a range of 1ml syringes. These will be the first automatically retracting 1ml safety syringes on the market, which should give the Group a major advantage over the competition and will further extend the range of our products. In addition to the safety syringe products described above, we have developed, to prototype stage, a safety I/V catheter, a safety phlebotomy set, and further extensions to the current safety syringe range. Recognising the sensitivity of these developments it would not be appropriate to provide further detail within this Report. However, the Group is confident that these potential new developments will not only broaden our future product offering, but will provide an excellent intellectual property platform to increase shareholder value in the years ahead. Legislation Legislative pressure for the use of safety needles continues to build in the US. Currently six States, California, Texas, Tennessee, New Jersey, Maryland and Hawaii have passed legislation mandating the use of safety needles by healthcare facilities. More than twenty other states have similar legislation pending. At the current pace of development, by the end of the year, safe needle legislation could apply to healthcare facilities operating over 60% of the hospital beds in the US. In addition to the legislation introduced by individual states, bipartisan needlestick protection legislation has been introduced to both the House of Representatives and the Senate, at Federal level. Moreover, the Federal Occupational Safety and Health Administration (OSHA) has recently published a revised Bloodborne Pathogens Directive. The new directive places emphasis on using safety needle products and on the requirement for healthcare facilities to conduct annual reviews of their bloodborne pathogen programme. One effect of this increase in legislation is that shortages of safety products are already being experienced in several US states. In addition, it has also presented established medical device manufacturers with unexpected problems, not just with capacity issues, but with breadth of product range difficulties. In Europe, the first signs are appearing of the development of union backed campaigns focussing on healthcare worker safety. These are similar to those promoted by the unions and professional bodies in the US, which were major factors in the initiation of the legislation there. Questions have also been asked in the Scottish Parliament, and we believe it is only a matter of time before the pressure forces a regulatory response in Europe. Regulatory and Intellectual Property The patent infringement lawsuit concerning NMT's safety syringes in the US is set down for hearing in the summer of this year. No new facts have emerged during the process of discovery to cause the Group's advisers to change their views on the prospects of success. Accordingly, we continue to believe that the lawsuit is unlikely to have a long-term material impact on our business. Elsewhere, we continue to establish comprehensive geographical protection for our core needle retraction technology, with patents granted in 25 jurisdictions and pending in a further 20. Patent applications have also been submitted in respect of a number of other products and inventions in the field of needlestick prevention. NMT's Quality System remains core to the Group's business. The challenges posed by the scale-up of our manufacturing operation place significant demands on the Quality System. We were pleased that a routine audit by our notified body, SGS Yarsley, in late 1999, indicated that the system was operating to the required standard with no concerns of significance. Facilities and Personnel At the time of writing the Group is taking possession of the extension to its premises in Livingston. This will add 35,000ft squared to the existing 24,000ft squared, and will facilitate a total of 7 cleanrooms plus storage space. We were granted early entry to the development to start work on the new cleanrooms, and anticipate that these will be ready to receive the third Sortimat 3ml machine and the Mikron 1ml machine shortly. In parallel with the expansion of our facilities, we have recruited a number of new key employees. In particular, we have significantly strengthened the Sales & Marketing team. Karen Dunlap has joined New Medical Technology, Inc. as Vice President of Sales for North America. She was previously Director of Sales for Futura (formerly Lukens Medical Corporation, a Medisys Group Company). Her extensive experience will prove invaluable to the Group's penetration of the North American market. Furthermore, Keith Gardner has joined as Marketing Manager (North America) from Closer Look Creative, Inc., where he was Account Manager for Eli Lilly and Company, with whom he had previously served in Sales and Marketing Communications roles. In Europe, Susan Murray joined as Marketing Manager, having previously worked with Ethicon, Sherwood Davis and Geck, and Sulzer Vascutek. Sales and Marketing In the US, the momentum continues to build steadily toward the adoption of safety products throughout the healthcare marketplace. This drive is being powered by state and national legislation, revitalized grassroots and organized labour activities, national agreements signed by the largest Hospital Purchasing Organizations, and the efforts by manufacturers to develop and introduce effective user-friendly new safety products such as NMT's Safety Syringe. Our experience from competing in these new 'all safety' markets, such as California, has provided excellent exposure to the key commercial issues. This will serve the Group well as these changes continue to spread rapidly across the US. We have observed the main driver in the market to be one of compliance with the new legislation, rather than the selection of the optimum solutions to the needlestick problem. Clearly, as the decision-makers continue to comply with the legislation, they will be required to analyse the effectiveness of the devices chosen. We are convinced that, as the market becomes more sophisticated, products that are rendered automatically safe in the normal course of a medical procedure, will prevail. Hence we are confident in the ability of our safety products to gain market share. Another effect of the legislation is that hospitals are no longer interested in protecting only those at highest risk, but all frontline healthcare staff. It is clearly undesirable to have a mixture of different safety technologies in the same hospital ward, and therefore there is a requirement for a broader range of needle sizes in order to satisfy this demand. As we progress through the year 2000, we will be in a stronger position to respond to this trend. In anticipation of introducing a broader range of 3cc products during 2000 and in response to the market opportunity in the US, we have increased the size of our US Sales and Marketing Group as referred to above. The calibre of these new additions to the Group is of the highest standard and their experience will prove invaluable going forward. We continue to evaluate and enhance our distribution network. We are confident that we have the network necessary to achieve success in our markets of focus: hospitals, physicians' offices, prisons, long-term care and occupational health. These markets currently represent over five billion syringes used annually. Our distribution partners and customers continue to believe in our technology and they have been very clear in their expectations. In order to convert prospective accounts, and to achieve success, we must be able to assure an adequate supply of a broad range of safety products. Our intention is to deliver all this and not just to meet, but to exceed, our customers' expectations. This will be achieved in a controlled manner, through internal focus on syringe assembly at our Livingston facility and utilising the competency of outside contractors when appropriate. In Europe, the level of awareness of the needlestick problem is still less than the US. Working with health and safety organisations, trade unions, politicians and opinion leaders from the healthcare profession we will continue to increase awareness of the seriousness of needlestick injury. Within the UK, the healthcare union, UNISON, and professional bodies, such as the Royal College of Nursing, are now active in launching awareness campaigns. Furthermore, during 1999 we were able to supply clinical data and economic analysis demonstrating the intrinsic value in the use of safety devices. Throughout Europe we have continued to evaluate and work with our distribution channels in Germany, Italy, France, Spain, Portugal, Switzerland, Scandinavia, Austria, Belgium and the UK. Many of these distributors have been appointed since early 1999, and, from detailed discussions with our partners, it is becoming increasingly apparent that we must be able to offer a broad range of safety products. Elsewhere, we announced in our Interim Report the appointment of ProMedica Pty Ltd as our distributor for Australia and New Zealand, and with their assistance we have gained regulatory approval for Zero-Stik in these markets. ProMedica are planning the launch of our Zero-Stik range during the second quarter of 2000. Our Business Development department has also been active in other key markets including Japan, South Africa and the Middle East. Financial Summary Turnover for the year was £66,000 (1998 £14,000), lower than anticipated due to the narrowness of our product range. The loss for the year of £7.06m (1998 £3.2m) was also greater than expected and included a provision of £690,000 for the writing down of stock which, due to its short residual shelf life, was considered to have become obsolete. Cash reserves at the year end amounted to £8.87m (1998 £3.4m). In March 1999, we announced a Placing and Open Offer of new shares to enable us to expand our manufacturing capacity more rapidly. The offering successfully raised £15.3m net of expenses. In December 1999, the Group received the second instalment, £600,000, of the Regional Selective Assistance (RSA) grant awarded in 1997. This brought the total received to £1.1m out of a total grant of up to £1.5m. In November, the Group was awarded a further RSA grant of up to £3m to assist in its expansion. This second grant will also be receivable in instalments and is linked to the Group's plans for continuing investment in capital assets and job creation. In January 1999, we entered into a lease of the first Sortimat assembly system and subsequently leased other capital equipment all of which yielded net finance of £1.2m. Since the year-end, we have entered into a lease of the second Sortimat machine, which has generated additional finance of £1.5m, and we are continuing to explore further leasing opportunities for future equipment. Outlook The transition from a research-based organisation into a vertically integrated medical device business is not without challenge. However, the Group remains confident that during 2000 we will show considerable progress in the achievement of our business objectives. The demand for safety products will continue to increase and we are poised to exploit the explosive growth that will undoubtedly occur within this market sector. Your Board is very much aware that further improvements will be necessary in order to expedite the transformation of the Group and we look forward to achieving our key milestones during 2000. Balance Sheets At 31 December 1999 Group Company ______ ______ 1999 1998 1999 1998 £'000 £'000 £'000 £'000 Fixed assets Intangible assets 1,810 1,930 1,110 1,230 Tangible assets 7,064 3,187 7,064 3,187 8,874 5,117 8,174 4,417 ______ ______ ______ ______ Current assets Stocks 520 54 520 54 Debtors 742 177 3,540 1,475 Cash at bank and in hand 8,868 3,411 8,849 3,263 10,130 3,642 12,909 4,792 ______ ______ ______ ______ Creditors Amounts falling due (2,555) (886) (2,514) (886) Within one year ______ ______ ______ ______ Net current assets 7,575 2,756 10,395 3,906 ______ ______ ______ ______ Total assets less current liabilities 16,449 7,873 18,569 8,323 ______ _____ ______ ______ Creditors Amounts falling due (1,782) (1,548) (1,782) (1,548) After more than one year ______ ______ ______ ______ Net assets 14,667 6,325 16,787 6,775 ______ ______ ______ ______ Capital and reserves Called up share capital 3,142 1,964 3,142 1,964 Share premium account 23,784 9,616 23,784 9,616 Profit and loss account (12,259) (5,255) (10,139) (4,805) ______ ______ ______ ______ Equity shareholders' funds 14,667 6,325 16,787 6,775 ______ ______ ______ ______ Consolidated Cash Flow Statement For the year ended 31 December 1999 1999 1998 £'000 £'000 Net cash outflow from operating activities (note 3) (7,140) (2,815) ______ ______ Returns on investments and servicing of finance Interest received 472 248 Interest paid (150) (6) 322 242 ______ ______ Capital expenditure and financial investment Purchase of tangible fixed assets (2,575) (1,772) ______ ______ Cash outflow before management of liquid resources and financing (9,393) (4,345) ______ ______ Management of liquid resources Cash (placed on)/ withdrawn from term deposit (4,300) 1,550 ______ ______ Financing Term loan - 1,500 Finance lease - repayment of principal (496) (99) Issue of shares 15,346 - 14,850 1,401 ______ ______ Increase/ (Decrease)in cash in the year 1,157 (1,394) ______ ______ Consolidated Profit and Loss Account For the year ended 31 December 1999 1999 1998 £'000 £'000 Turnover 66 14 Cost of sales (note 4) (2,388) (13) _______ ______ Gross (loss) / profit (2,322) 1 Administration expenses (5,708) (3,961) Other operating income 612 500 ______ ______ Operating loss (7,418) (3,460) Interest receivable 509 228 Interest payable (150) (6) ______ ______ Loss on ordinary activities before and after tax (7,059) (3,238) ______ ______ Loss per share Basic and diluted loss per share (12.6)p (8.2)p ______ ______ NMT Group PLC Notes to the Financial Statements For the year ended 31 December 1999 1 Basis of preparation This preliminary announcement has been prepared on the basis of accounting policies consistent with those set out in the Directors' Report and Accounts for the year ended 31 December 1998. The information shown for the year ended 31 December 1999 does not constitute statutory Accounts within the meaning of Section 240 of the Companies Act 1985. 2 Reconciliation of net cash flow to movement in net funds 1999 1998 £'000 £'000 Increase/ (Decrease) in cash in the year 1,157 (1,394) Cash outflow from finance leases - repayment of principal (994) (1,596) Cash inflow/ (outflow) from increase in liquid resources 4,300 (1,550) ______ ______ Change in net funds resulting from cash flows and movement in net debt in the year 4,463 (4,540) Net funds at 31 December 1998 1,815 6,355 ______ ______ Net funds at 31 December 1999 6,278 1,815 ______ ______ 3 Reconciliation of Operating Loss to Net Cash Outflow 1999 1998 £'000 £'000 Operating loss (7,418) (3,460) Amortisation of intangible fixed assets 120 20 Depreciation on tangible fixed assets 653 282 Share options - application of UITF 17 55 55 Movement in: (Increase) in stocks (466) (54) (Increase) /decrease in debtors (528) 45 Increase in creditors 444 297 ______ ______ Net cash outflow from operating activities (7,140) (2,815) ______ ______ 4 Cost of Sales Cost of sales for the year includes £373,000 attributable to producing product for sale on the Kahle assembly line. This line is designed primarily for the development of future products, not for the assembly of product on a commercial basis as it is considerably more costly to operate in terms of labour and manufacturing overhead costs. The line was used at this stage in the development of the Company to maximise the breadth of product available to customers. As more of the Company's fully automated production capacity comes on line, the use of the development line for this purpose will be phased out. Cost of sales includes a provision of £690,000 for the reduction in value of finished goods stock because of obsolescence. The obsolescence related to shelf life of stock at 31 December 1999 or the projected date of sale.
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