Final Results

Deltex Medical Group PLC 24 March 2004 24 March 2004 Deltex Medical Group plc Preliminary results for the year ended 31 December 2003 Significant progress in 2003 Deltex Medical Group plc ('Deltex Medical'/'Group'/'Company'), the AIM listed haemodynamic monitoring company, announces its results for the year to 31 December 2003. Highlights • Turnover increased by 74% to £3,084,000 (2002: £1,776,000) • Gross profit rose by 110% to £1,862,000 (2002: £886,000) • Operating loss for the year decreased to £2,425,000 (2002: £3,261,000) • Combined sales to key markets of UK and Europe more than doubled • Continuing reductions in cash burn • Marketing approach implemented to encourage closer collaboration between doctors and managers, resulting in significant progress in making healthcare system funds available to purchase the company's technology • Our first wide-scale hospital deals achieved in the UK: sufficient monitors and probes supplied to ten NHS hospitals for routine use in both operating theatres and in critical care • Arranged a series of post-procurement audit projects in UK National Health Service Trusts to demonstrate the economic benefit of haemodynamic optimisation in moderate and major surgery • Development and implementation of country-specific sales and marketing plans in conjunction with our distributor partners in Europe, increasing sales by over 60% year on year • Development and launch of a nasally compatible probe for use in intensive care, a range of probes for use in awake patients and a dedicated paediatric probe for use in children undergoing surgery or in intensive care Chairman, Nigel Keen, commented: 'Deltex Medical made significant progress in 2003. Doctors are increasingly recognising the clinical benefits associated with optimising their patients' haemodynamic status in the operating theatre and intensive care unit. Hospital and healthcare managers are becoming increasingly aware that haemodynamic optimisation can provide significant economic benefits to the wider healthcare system. 'Across the world, healthcare providers are searching for new ways to provide the highest quality of care within ever tighter budgetary constraints. It is our ability to help patients get better, quicker and to reverse the spiralling costs to the system of haemodynamic compromise that provides the enormous opportunity for Deltex Medical.' For further information, please contact:- Enquiries Deltex Medical Group plc Nigel Keen, Chairman nigel.keen@deltexmedical.com 01243 774 837 Andy Hill, Chief Executive andy.hill@deltexmedical.com 01243 774 837 Ewan Phillips, Finance Director ewan.phillips@deltexmedical.com 01243 774 837 Charles Stanley & Co. Ltd Philip Davies 0207 953 2000 Financial Dynamics Stephanie Highett/Francetta Carr stephanie.highett@fd.com 0207 831 3113 Notes for Editors Deltex Medical primarily develops, assembles and markets a cardiac function monitor and therapy guidance device, the CardioQTM ('CardioQ'). The CardioQ incorporates the Company's proprietary software and a small diameter, easy-to-use, minimally invasive, disposable oesophageal probe that is used for transmitting and receiving an ultrasound signal. By using this technology, the CardioQ provides clinicians with the ability to haemodynamically optimise critically ill patients and those undergoing routine moderate to major surgery through the controlled administration of fluid and drugs. Haemodynamic optimisation has been scientifically proven to improve the speed and quality of patient recovery and reduce hospital stay. There are already over 1,250 CardioQs currently in use in hospitals worldwide and distribution arrangements are in place in over 30 countries. In addition, there are currently more than 75 clinical publications on the use of the CardioQ which have repeatedly:- • validated the results of the CardioQ against known standards for measuring cardiac output, demonstrating that the technology works • proved that the CardioQ works in a wide range of surgical procedures • demonstrated that the Company's technology provides significant health and economic benefits by helping to reduce post-operative complications and length of hospital stays by an average of 30 to 40 per cent for a wide range of patients. Deltex Medical - Chairman's Statement Group Overview The human body delivers oxygen to all its major organs through the circulation of blood around the system. In critically ill patients, or when individuals are involved in a traumatic event, it is vital that the clinician is given information to ensure that this blood circulation is continuing properly (' haemodynamic optimisation'). If adequate oxygen delivery is not maintained for any extended period of time ('haemodynamic compromise'), the patient takes longer to recover, does not recover completely or does not recover at all. Similarly, patients who undergo routine moderate and major surgery are at risk of complications and extended hospital stay due to haemodynamic compromise. This is because all surgical patients are denied fluid and food for a period prior to their operation ('nil by mouth'). During the operation they are treated with anaesthetic agents that affect the body's ability to compensate for the dehydration caused by the nil by mouth regime; and are further compromised through blood loss and evaporation from the wound during the surgical procedure. Deltex Medical has developed and established a cardiac function monitoring system, the CardioQTM, which it manufactures and markets. The CardioQ monitor uses Doppler ultrasound technology to provide the clinician with information to allow them to ensure that critically ill patients and those undergoing moderate and major surgery are haemodynamically optimised. Data is provided to the clinician through a disposable probe which is inserted into the patient's oesophagus through the mouth or nose. Using this data, the doctor is able to intervene actively to manage the patient's fluid status with the goal of achieving, and then maintaining, haemodynamic optimisation. Clinical studies have repeatedly shown that using the CardioQ provides significant health and economic benefits by helping to reduce post-operative complications and length of hospital stays by more than 30% on average for a wide range of patients. Whilst originally designed for use in sedated patients, the Company has developed a range of probes that extend the use of the CardioQ to awake patients. Deltex Medical is also developing a wholly non-invasive monitoring solution that will enable doctors to assess rapidly the patient's haemodynamic status from the time that he or she arrives in the healthcare system, whether at the site of an accident or on admission to hospital, through to discharge of the patient from the hospital. Deltex Medical's strategy, and its goal, is to make haemodynamic optimisation, guided by the CardioQ, a standard of care in operating theatres, intensive care units and accident and emergency departments worldwide. This will enable doctors to guide therapy which will help them make their patients better, quicker. Trading Results Deltex Medical made significant progress in 2003. Doctors are increasingly recognising the clinical benefits associated with optimising their patients' haemodynamic status in the operating theatre and intensive care unit. Hospital and healthcare managers are becoming increasingly aware that haemodynamic optimisation can provide significant economic benefits to the wider healthcare system because haemodynamically optimised patients recover more fully, more quickly and can leave hospital earlier than would otherwise be the case. In the year to 31 December 2003, sales increased by 74% to £3,084,000. Probe sales were 35,000, up from 24,000 in 2002, representing an increase of 46%. Monitor sales increased 37% to 276 units compared to 201 in 2002. The installed base of CardioQs (which includes units placed against recurring probe commitments) increased by 49% from 841 at the end of 2002 to 1,253 by the end of 2003. The net loss before taxation for the year amounted to £2,396,000 (2002 £3,135,000). In the second half of the year, sales doubled while the net operating loss decreased from £1,700,000 to £700,000. Approximately £650,000 of costs associated with post-procurement audit projects will be charged in the first half of 2004 as the hospitals involved deliver the data collection and analysis specified in the projects. During the period the Company implemented an Enterprise Management Incentive Scheme in order that senior managers could be paid bonuses earned in shares rather than in cash. The profit and loss account charge under UITF17 in respect of these bonuses was £223,000. Cash at the end of the year was £1,093,000 with debtors at record levels following particularly strong December sales. The underlying level of cash burn continued to reduce throughout 2003 as sales increased. Further reductions in the burn rate have been realised since the year end and the month-on-month burn rate is now significantly lower than at any similar period in the Company's history. During the period the Company raised a total of £2,029,000 after expenses in additional equity capital via the issue of 24,467,768 1p ordinary shares. The proceeds from these fundraising activities provided additional working capital to expand and accelerate the penetration of the UK and key European markets. The UK, our home market, is our most successful sales region to date. There are now over 400 CardioQs in regular use in approaching 200 hospitals in the UK. This means that at the end of the year more than half of the major UK NHS hospitals were using the CardioQ. Haemodynamic optimisation has become a standard of care in specific applications in many of these institutions. Demand for education and training reflects this growing reliance on our technology. On average our UK clinical training team was teaching 450 medical staff in the class room and in excess of 170 at the bedside every month during 2003. Approximately 55 patients were being monitored on average each day at the end of 2003 compared to approximately 25 each day coming into the year with significant potential for further increases as monitors installed towards the end of the year come into routine use. Probe sales in the UK doubled from 10,000 in 2002 to 20,000 in 2003. 30% of this increase came from continued steady growth in our UK intensive care business and 70% from the increasing uptake of our operating theatre probes. Market Development United Kingdom Fundamental changes are currently being introduced into the UK National Health Service. The changes relating to funding and the policy of 'payment by results' represent a significant opportunity for the CardioQ system. Being closer to our customers has enabled us to devise and implement a variety of unique strategies tailored to these changes. In addition, our relationships with leading doctors in the UK and overseas has led directly to the development of a range of new probe solutions for specific applications in operating theatres, awake patients and in children. We are closely involved with a working group of senior doctors who are developing guidelines for improving the care of patients undergoing moderate and major surgery. These guidelines have at their heart the recommendation that haemodynamic optimisation become a standard of care in these patients. It is the intention of this group to secure the endorsement of these guidelines by the Royal Colleges of Anaesthesia and Surgery and the Intensive Care Society While haemodynamic optimisation leads to quicker, fuller recovery in patients undergoing surgery or in critical care, it is the fact that patients are fit to leave hospital earlier and consume less care resource during their stay that is of significant interest to hospital and healthcare managers. As a result, a number of hospitals in the UK have been evaluating the use of the CardioQ in all patients undergoing moderate and major surgery. In order to accelerate the wide-scale use of the CardioQ, in December the Company entered into partnership arrangements with the five Trusts that were furthest along the path to implementing this approach. Ten hospitals within these trusts are undertaking a post-procurement audit, the primary objective of which is to evaluate the economic impact of haemodynamic optimisation at each site from a management perspective so we can use the data to accelerate the spread of hospital-wide adoption across the UK. These Trusts have purchased monitors to the value of £387,000 in order to be able to treat the vast majority of their patients undergoing moderate and major surgery and in intensive care. In addition, these Trusts purchased £253,000 of disposable probes in 2003, sufficient to meet the training needs for these monitors and to allow them to participate in the post-procurement audit. Deltex Medical has committed to provide the Trusts with an equivalent amount of funding (£640,000) towards the cost to the Trusts of the extensive data collection and analysis that this post-procurement audit entails. These projects are expected to come to a conclusion in the summer of 2004. Since the year end, in these hospitals, significant numbers of doctors, nurses and other staff responsible for treating patients undergoing moderate and major surgery have been trained in the use of the CardioQ and seven of the ten hospitals have already started collecting the results of treating large volumes of patients. Feedback from all the sites is positive and indicates that patients being haemodynamically optimised are receiving significantly greater amounts of fluid at an earlier stage than before. Anecdotal evidence is growing that these positive clinical changes are beginning to result in reduced pressure on scarce resources in the hospitals concerned. Overseas Markets Continental Europe In late 2002 we created a small, dedicated team to support our distributor partners in Europe. This has enabled us to build on our UK experience and develop country-specific strategies for accelerating sales. The team has focused on creating stronger, more effective links with the distributors and developing a partnership approach to strategy development. We have put in place a focused clinical training programme and presented educational seminars to more than 500 clinical staff across Europe during the year. Combined with targeted distributor training undertaken at one of our UK hospital training sites, we now have a powerful message with which to create awareness of our technology and the benefits of haemodynamic optimisation. Consequently, sales growth of over 60% was achieved in 2003 compared to the prior year. Our key European markets remain France, Italy and Spain, although their relative contribution to European revenues is reducing as sales increase in other countries. In key countries we have been able to identify opportunities for hospital-wide projects similar to the post-procurement audit projects currently underway in the UK. United States Throughout 2003 we continued with our strategy of creating a scaleable business model in the USA that we can roll-out nationally with a partner. Our small clinical educator sales team has continued to focus on a limited number of accounts and made good progress in expanding adoption of the CardioQ in these hospitals. We are actively working on a number of parallel approaches to accelerate adoption in the USA. Each approach is tailored to a specific type of healthcare provider organisation in this complex market. We are currently engaged in discussion with one of the major hospital groups to implement a post-procurement audit project based on our experience in the UK. This group intends to undertake the project at its own expense at one of its key sites in Texas. It is currently anticipated that this project may reach its conclusion in the last quarter of 2004. Far East and South America Sales in the Far East and South America have not been as strong as we had hoped. This is mainly related to difficulties with reimbursement of medical device technologies that affect all manufacturers. On the whole, our distributor partners are working well in a bureaucratic environment over which they have only minimal influence. Encouragingly, interest in our products in these regions is growing and mirrors the increasing recognition of the benefits of haemodynamic optimisation seen in the UK and Europe. However, these markets, although sharing many of the issues that face healthcare systems elsewhere in the world, have low labour costs and a less sophisticated approach to health-economics. This makes a cost-effectiveness argument less likely to persuade the healthcare managers to make funds available to doctors wishing to use our products in the short-term than elsewhere. In light of these complexities, we reduced our support in the South American territories late in 2003 and are working actively with our distributors to determine the best approach going forward. Our priority in these regions is to determine which countries merit continued investment in the short- term and which should be left to continue to work with our technology with a lower level of clinical support from us. After several false starts we have begun to see regular orders for probes from our Korean distributor. Most of the regulatory and reimbursement barriers to the clinical demand for the CardioQ in Korea appear finally to have been overcome. We are working with our distributors in Japan, China and Taiwan to unlock the significant business opportunity in these countries. Our plans going forward will be targeted to create the greatest value from available resources and with minimal additional investment. Research and Development A key focus of our Research and Development activity in 2003 has been to provide the specific probe solutions required to address the specific clinical needs identified by our sales and marketing activities. We have now complemented our dedicated surgical probe range with a longer duration, nasally compatible probe for use in intensive care; a dedicated probe for use in children undergoing surgery or in intensive care; and a range of probes for use in awake patients. Each of these new products has been developed to share a common technology platform, providing greater flexibility in manufacturing while creating opportunities to reduce component stock levels. Our research and development team has been working on accelerating the development of the SupraQTM, a wholly non-invasive monitoring solution that provides a 'snapshot' of a patient's haemodynamic status. The opportunity for this monitoring approach is considerable and we have already identified a number of important clinical areas where such a device could have wide application. The potential range of clinical applications of the SupraQTM is significantly broader than that of the CardioQ, meaning that one day patients could benefit from use of the Company's technology throughout the whole healthcare system. Early feedback on evaluation units in clinical use has been very positive. Additionally, we have begun the process of specifying the successor to the CardioQ and have successfully completed the initial clinical validation of the new generation computing platform that will form the core of this and future monitors. Key Achievements Our key achievements during this period have been to: • Increase turnover by 74% • Implement a marketing approach that builds bridges between doctors, who want to make haemodynamic optimisation a standard of care in their practice, and healthcare managers, who want to provide high quality healthcare cost effectively. This approach has enabled us to make significant progress in making healthcare system funds available to purchase our technology • Achieve our first wide-scale hospital deals in the UK, supplying sufficient monitors and probes to ten NHS hospitals to cover routine use in both operating theatres and in critical care • Arrange a series of post-procurement audit projects in UK NHS Trusts to demonstrate the impact of haemodynamic optimisation in moderate and major surgery and in intensive care from a management perspective • Develop and implement country-specific sales and marketing plans in conjunction with our distributor partners in Europe, increasing sales by over 60% year on year • Upgrade our quality and regulatory systems to successfully comply with changes to international standards governing the sale of our medical devices in Europe • Successfully complete our first on-site US Food and Drug Administration (FDA) inspection • Successfully upgrade our FDA 510K approval to sell the CardioQ system in the USA • Develop and launch a nasally compatible probe for use in intensive care, a range of probes for use in awake patients and a dedicated paediatric probe for use in children undergoing surgery or in intensive care Prospects The momentum that Deltex Medical created in 2003 is continuing to build in the first few months of 2004. Haemodynamic optimisation is at the top of the agenda for doctors managing patients undergoing moderate and major surgery and in intensive care. It is becoming clear to the hospitals which use the CardioQ system that Deltex Medical provides the best tools, the best training, and the best support for doctors and healthcare managers that want to make haemodynamic optimisation a standard of care in their hospitals. In order to maintain this momentum we will have to manage carefully our limited resources to enable us to continue to develop the opportunities open to us without overstretching the funding capabilities of the business. Across the world, healthcare providers are searching for new ways to provide the highest quality of care within ever tighter budgetary constraints. It is our ability to help patients get better, quicker and to reverse the spiralling costs to the system of haemodynamic compromise that provides the enormous opportunity for Deltex Medical. The partnerships we are forging with doctors and healthcare managers in the UK, the USA and in Europe will be instrumental for us to reach our overarching goal - making haemodynamic optimisation, driven by our technology, a standard of care in surgery, critical care and throughout the healthcare system. By achieving this we are confident that we will deliver increasing and sustainable value to our shareholders. Nigel Keen Chairman 24 March 2004 Consolidated profit and loss account for the year ended 31 December 2003 2003 2002 Note £000 £000 Unaudited Audited Turnover 2 3,084 1,776 Cost of sales (1,222) (890) ------ ------ Gross profit 1,862 886 ------ ------ Net operating expenses (4,287) (4,147) ------ ------ Operating loss (2,425) (3,261) Net interest receivable 29 126 ------ ------ Loss on ordinary activities before taxation (2,396) (3,135) Tax on loss on ordinary activities 4 233 ------ ------ Loss for the financial year (2,392) (2,902) ====== ====== Loss per share - basic and diluted (4.7p) (7.8p) ====== ====== The above results all relate to continuing operations. The loss on ordinary activities before taxation and the loss for the financial year have been computed on the historical cost basis. Statement of Group total recognised gains and losses for the year ended 31 December 2003 2003 2002 £000 £000 Unaudited Audited Loss for the financial year (2,392) (2,902) Currency translation differences in foreign (55) (83) currency net investment ------ ------ (2,447) (2,985) ====== ====== Consolidated balance sheet At 31 December 2003 2003 2002 £000 £000 Unaudited Audited Fixed assets Tangible assets 191 340 ----- ----- Current assets Stocks 572 649 Debtors 1,953 956 Cash at bank and in hand 1,093 2,021 ----- ----- 3,618 3,626 Creditors: amounts falling due within one year (1,059) (1,050) ----- ----- Net current assets 2,559 2,576 ----- ----- Creditors: amounts falling due after more than one year - (1) ----- ----- Net assets 2,750 2,915 ===== ===== Capital and reserves Called up share capital 617 3,693 Share premium account 10,381 8,597 Capital redemption reserve 17,476 14,125 Merger reserve 1,776 1,776 Profit and loss account (27,500) (25,276) ----- ---- Equity shareholders' funds 2,750 2,915 ===== ===== Consolidated cash flow statement for the year ended 31 December 2003 2003 2002 Note £000 £000 Unaudited Audited Net cash outflow from operating activities 3 (2,960) (3,360) ------ ------ Returns on investments and servicing of finance Interest received 31 130 Interest paid (2) (3) ------ ------ Net cash inflow from returns on 29 127 investments and servicing of finance ------ ------ Taxation 36 85 Capital expenditure Purchase of tangible fixed assets (45) (241) Sale of tangible fixed assets - 1 ------ ------ Net cash outflow from capital expenditure (45) (240) ------ ------ Net cash outflow before financing (2,940) (3,388) ------ ------ Financing Issue of ordinary share capital 2,161 - Expenses in connection with share issue (132) - Capital element of finance lease rentals (5) (8) ------ ------ Net cash inflow/(outflow) from financing 2,024 (8) ------ ------ Decrease in net cash in the year (916) (3,396) ===== ===== Notes to the preliminary statement for the year ended 31 December 2003 1. Nature of the financial information The financial statements for Deltex Medical Group plc have yet to be approved for the year ended 31 December 2003. The financial information set out in the announcement does not constitute the Company's statutory accounts for the year ended 31 December 2003 or 31 December 2002. The financial information for the year ended 31 December 2002 is derived from the statutory accounts for that year which have been delivered to the Registrar of Companies. The auditors reported on those accounts; their report was unqualified and did not contain a statement under either Section 237 (2) or Section 237 (3) of the Companies Act 1985. The statutory accounts for the year ended 31 December 2003 will be finalised on the basis of the financial information presented by the directors in this preliminary announcement and will be delivered to the Registrar of Companies following the Company's Annual General meeting. The preliminary results have been prepared in accordance with applicable accounting standards. The particular accounting policies adopted are the same as those adopted in the financial statements for the year ended 31 December 2003. 2. Turnover The Group's activities consist solely of the manufacture and marketing of medical devices. By origin, all sales are United Kingdom sales. 2003 2002 £000 £000 Unaudited Audited Analysis of turnover by destination United Kingdom 1,878 731 United States of America 357 353 Rest of Europe 654 401 Rest of the World 195 291 ------ ----- 3,084 1,776 ====== ===== 3. Reconciliation of operating loss to net cash outflow from operating activities 2003 2002 £000 £000 Unaudited Audited Operating loss (2,425) (3,261) Depreciation on tangible fixed assets 186 304 Loss on sale of fixed assets - 9 Exchange differences (19) - Decrease in stocks 77 3 Increase in debtors (1,029) (367) Increase/(decrease) in creditors 27 (48) Costs associated with share option scheme 223 - ------ ------ Net cash outflow from operating activities (2,960) (3,360) ======= ======= 4. Dividends The directors do not recommend payment of a dividend (2002: nil). 5. Loss per share The loss per share calculation for 2003 is based on the loss for the financial year of £2,392,000 and weighted average number of shares in issue of 50.8 million. For 2002 the loss per share calculation was based upon the loss of £2,902,000 and weighted average number of shares in issue of 36.9 million. The Group had no dilutive potential ordinary shares in either year, which would serve to increase the loss per ordinary share. Therefore there is no difference between the loss per ordinary share and the diluted loss per ordinary share. 6. Distribution of announcement Copies of this announcement are being sent to all shareholders and will be available for collection free of charge from the Company's registered office at Terminus Road, Chichester, West Sussex PO19 8TX. This information is provided by RNS The company news service from the London Stock Exchange
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