Annual Report PiCCO-Technology has become the medical standard

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1 Annual Report 2004 PiCCO-Technology has become the medical standard 04

2 Facts and figures PULSION 2004 PULSION (GROUP) 2004 Variance in % Revenues EUR million % Gross profit EUR million % EBITDA EUR million % EBIT EUR million 1.2 n.a Net income/net loss EUR million 0.9 n.a Cash flows used in operating activities EUR million % Shareholders Equity 1) EUR million % Shareholders Equity percentage 1) % 52% 50% 38% Total assets 1) EUR million % R&D expenses EUR million % Employees (average) Amount 79 2% Revenue per employee KEUR % Installed base PiCCO monitors 1) Units 3,479 22% 2,854 2,474 1) as of December 31 02

3 4 Contents 05 Foreword by the Management Board 07 Highlights Products and Technologies 12 Markets and business model 14 Investor Relations 15 Our Vision 16 Report of the Supervisory Board 19 Consolidated financial statements (U.S. GAAP) 20 Group Management Report 32 Consolidated balance sheet 34 Consolidated income statement 35 Consolidated cash flow statement 36 Consolidated statement of changes in stockholders equity 36 Consolidated analysis of non-current assets 38 Notes to the consolidated financial statements 58 Independent Auditors Report 59 Financial calender 03

4 Matthias Bohn Member of the Management Board Stefan Land Member of the Management Board With PULSION now operating on a profitable basis with a stable cash flow, this will clearly help us to achieve our ambitious targets. 04

5 02 Facts and figures 05 Foreword by the Management Board 07 Highlights Products and Technologies 12 Markets and business model 14 Investor Relations 15 Our Vision 16 Report of the Supervisory Board 19 Consolidated financial statements (U.S. GAAP) 20 Group Management Report 32 Consolidated balance sheet 34 Consolidated income statement 35 Consolidated cash flow statement 36 Consolidated statement of changes in stockholders equity 36 Consolidated analysis of non-current assets 38 Notes to the consolidated financial statements 58 Independent Auditors Report 59 Financial calender Foreword by the Management Board A healthy balance sheet good prospects for the future Dear customers, shareholders and colleagues, 2004 was a year of rich harvest and simultaneous expansion for PULSION. On the one hand, we were able to start reaping the benefits of the 2003 cost-saving program and our efforts to build up the business over the past years, as can be seen by the fact that PULSION s sales revenue increased by 19 % to Euro 16.3 million and EBIT grew to Euro 1.2 million. On the other hand, we also made substantial investments during the past financial year in the area of research and development and to prepare the market in North America. This success is founded on the unique position of PULSION s products within the market and the fact that our customers can be offered significant cost savings compared to the cost of conventional diagnostic and therapeutic methods. After achieving the turnaround in the second half of 2003, the EBIT percentage margin has risen in 2004 to approximately 7 %. Earnings per share amounted to Euro PiCCO-Technology, which is the driving force behind PULSION, has established itself as the medical standard for haemodynamic monitoring in Germany and Europe and is now marketed using a smoothly functioning multi-channel sales strategy. Following on from license agreements with Philips Medical Systems and Dräger Medical, PULSION succeeded in 2004 in convincing two further leading medical equipment manufacturers - GE Healthcare Technologies and Spacelabs Medical to link up PiCCO-Technology in future with their patient monitoring systems. In future, therefore, our technology will be used by virtually all of the major suppliers in this area or will be capable of being used in conjunction with their systems. The installed base of PiCCO systems, which is the foundation for our business with disposable catheter kits, rose during the year under report from 2,854 to 3,479 units, an increase of 22 %. On top of this, almost 6,800 PiCCO modules have been sold in the meantime by our partner, Philips Medical Systems. Obtaining approval for ICG-PULSION in further European countries is essential to our future growth. ICG-PULSION is now being actively marketed in these countries both in the field of ophthalmics, where it is used independently of our technology, and in conjunction with PULSION s LiMON and IC-VIEW technologies, both of which are based on ICG-PULSION. PULSION has been able to register good performances with these technologies in The number of LiMON monitors rose by 29 % to 347 and, in addition, an important license was issued for IC-VIEW which enables this technology to be incorporated into Carl Zeiss neurosurgical microscopes and therefore opens up an additional new sales channel for PULSION. CeVOX, which was first presented in March 2004, is yet another promising technology which is about to be launched. This is another example of how PULSION is creating additional highly promising product lines, alongside the core product, PiCCO, for use in the treatment of critically ill patients in casualty departments and intensive care units. PULSION products are extremely innovative and introduce into clinical practice new or additional measurement indicators, which allow decisions relating to treatment to be made sooner, more quickly and more accurately. Appropriate marketing strategies are required to ensure that this new approach to diagnosis, patient monitoring and therapy management now becomes established in the mainstream. As the financial statements show, our continuing 05

6 EUR million 1,4 1,2 1,0 0,8 0,6 0,4 0,2 0,0-0,2-0, After achieving the turnaround in the second half of 2003, the EBIT grew to Euro 1.2 million in endeavours with PiCCO-Technology in Europe are already beginning to pay off. This success will be extended successively to our other product lines and markets. Most important of all, we are able to use good scientific arguments to advance the process of ensuring that our highly innovative technologies become an established part of hospital clinical routines in the long-term. In Germany, we have already been able to convince a host of influential hospitals mainly university hospitals or renowned specialist clinics to use our LiMON and IC-VIEW technologies. With PULSION now operating on a profitable basis with a stable cash flow, this will clearly help us to achieve our ambition targets. The scope for growth remains enormous, both in PULSION s core business and with our new products. Although PULSION is therefore now in a comfortable position, there will be no let-up in our policy of making continual improvements. This applies in particular to the expansion of marketing, sales and production activities as well as to the development of new technologies. The first PiCCO expertise centers have been set up in the USA, creating the basis for new partnerships to support an effective and powerful sales organization. We have set the following priorities for the financial year 2005: pushing ahead with our US strategy; obtaining approvals for ICG-PULSION in the remaining EU countries and submitting an application for approval in the US; marketing CeVOX on a broader basis; starting CiMON sales; and advancing the process of embedding our technologies into clinical routines. We would like to express our gratitude to all of our employees for their huge commitment. The success achieved over the past years would not have been possible without them. Thank you very much! Yours truly Matthias Bohn Member of the Management Board Stefan Land Member of the Management Board 06

7 02 Facts and figures 05 Foreword by the Management Board 07 Highlights Products and Technologies 12 Markets and business model 14 Investor Relations 15 Our Vision 16 Report of the Supervisory Board 19 Consolidated financial statements (U.S. GAAP) 20 Group Management Report 32 Consolidated balance sheet 34 Consolidated income statement 35 Consolidated cash flow statement 36 Consolidated statement of changes in stockholders equity 36 Consolidated analysis of non-current assets 38 Notes to the consolidated financial statements 58 Independent Auditors Report 59 Financial calender Highlights 2004 March: PULSION introduces a new product, CeVOX, for which there is a great deal of demand. With this product, pre-heart oxygen saturation can be measured continuously and economically with a minimally invasive approach, using a process which does not require an additional venous line, thus making it possible to make an early diagnosis of sepsis, one of the most common causes of death in intensive-care patients. June: A British-American research group publishes favourable research results on the PiCCO radial catheter. This provides the basis for the application of PiCCO-Technology in operations where it is not possible to catheterise the femoral artery. It opens up a completely new market segment, significantly widening the overall market for PULSION. September: The British medical authority, MHRA, informs PULSION of the favourable conclusion of reciprocal EU approval proceedings to recognise the drug ICG-PULSION in Belgium, Ireland, Italy, the Netherlands, Austria, Portugal and Sweden. In line with EU law, PULSION will soon have the required approval to be able to market ICG-PULSION in the above-named countries. November: Arrangements are put in place to allow PiCCO to be linked up to patient monitoring systems sold by GE Healthcare Technologies and Spacelabs Medical. This means that almost all leading manufacturers of patient monitoring systems will offer PiCCO-Technology. November: PULSION doubles its EBIT forecast for 2004 from Euro 0.5 million to Euro 1 million. December: Leading authorities in the medical field acknowledge PiCCO-Technology as the accepted standard for Germany. 07

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9 02 Facts and figures 05 Foreword by the Management Board 07 Highlights Products and Technologies 12 Markets and business model 14 Investor Relations 15 Our Vision 16 Report of the Supervisory Board 19 Consolidated financial statements (U.S. GAAP) 20 Group Management Report 32 Consolidated balance sheet 34 Consolidated income statement 35 Consolidated cash flow statement 36 Consolidated statement of changes in stockholders equity 36 Consolidated analysis of non-current assets 38 Notes to the consolidated financial statements 58 Independent Auditors Report 59 Financial calender Products and Technologies PiCCO PULSION s technological success story PULSION s most important line of products at present relates to PiCCO-Technology, a system used for diagnosis, monitoring and therapy regulation in the management of critically ill patients in the perioperative period and in intensive care. With the aid of an arterial catheter, and making use of the central venous line which is already in situ, PiCCO measures and collects data on important cardiac and circulatory functions, such as cardiac output, the contractile force and efficiency of the heart, the blood volume in the chambers of the heart, the water content of the lungs and the systemic vascular resistance. PiCCO-Technology is protected by more than 150 patents and patent applications. Simple, safe, quick, accurate PiCCO is increasingly taking over from the right-heart catheter, which has been in use since the seventies, to take the relevant measurements. PiCCO has several advantages over the right-heart catheter which has to be flushed through the chambers of the heart and into the pulmonary artery. The data collected enable rapid and more accurate diagnoses to be made; the procedure is less invasive and therefore represents a lower risk for the patient. The PiCCO catheter can also be used over a longer period of time. PiCCO is also simpler for medical and nursing staff to use and interpret. Yet PiCCO is considerably more economical than the right-heart heart catheter. As a result PULSION has consistently recorded double-digit sales volume growth rates for equipment and catheters over several years. The rising number of PiCCO systems ensures a constant growth in business with sterile products. Cooperation agreements with manufacturers of patient monitoring systems In its stand-alone monitor form, PiCCO is sold directly by PULSION. Many hospitals prefer, however, to integrate PiCCO into their existing patient monitoring systems. It is therefore PULSION s aim to enter into cooperation agreements with all leading manufacturers of such monitoring systems. In 2004, PULSION succeeded in reaching agreements with GE Healthcare Technologies and Spacelabs Medical to add PiCCO-Technology to their monitoring systems. Thus the world s three largest manufacturers of patient monitoring systems Philips Medical Systems, Dräger Medical and GE Healthcare Technologies will in future be offering PiCCO actually integrated into their systems or linked with their systems. On the way to becoming the gold standard The aim is for PiCCO-Technology to become the recognised standard and thus a routine item on hospitals tenders for new patient monitoring systems. This can be achieved by familiarising the medical profession more and more with PiCCO, using the opportunities offered by the world s major congresses on intensive care as well as by means of scientific and clinical studies. PULSION reached an important milestone in Germany at the end of last year. At the congress of the German Interdisciplinary Association of Intensive Care and Emergency Medicine, (DIVI 2004), PiCCO was declared to be the new preferred clinical standard for cardio-vascular monitoring and management. PULSION has thus moved one step closer to its goal of making PiCCO the "gold standard for haemodynamic diagnostics. Huge market potential PiCCO is the most important source of revenue for PULSION and the underlying basis for profitability; it is also the way-in for other PULSION products which cater for the needs of intensive care and emergency medicine. No other methods apart from the right-heart catheter have so far been able to prove their worth in the area of intensive care medicine. The potential for expansion with PiCCO is far from being exhausted. In Europe, PiCCO-Technology is winning the battle to get itself established; in Asia, the ground is currently being laid to repeat the success already achieved in our core markets; and in the USA we are still in the phase prior to the start of active marketing. The annual worldwide market potential for PiCCO could be in excess of Euro 2 billion. 09

10 ICG-PULSION a whole world of new opportunities ICG-PULSION (Indocyanine green) is a very well-tolerated diagnostic agent which is injected into the bloodstream. Its main applications are for investigations of the cardiovascular system, liver function and microcirculation. LiMON and IC-VIEW technologies work on the basis that ICG-PULSION is only broken down by the liver and that ICG-PULSION has excellent contrast properties. ICG-PULSION is in the process of obtaining for approval in a number of important EU countries. ICG-PULSION has already received approval for Germany, Great Britain and Israel, and is actively sold on these markets; several other European states have issued approvals and marketing is due to commence shortly (see highlights, page 7). ICG-PULSION is used particularly successfully in ophthalmics to provide a graphic depiction of the fundus of the eye. In this way, it is possible, above all, to diagnose diseases which can be identified through alterations in the blood vessels, such as diabetes. In both surgery and internal medicine, ICG-PULSION is employed in conjunction with IC-VIEW to depict the blood supply to the skin, tissues, and organs; in intensive-care medicine, it is used with LiMON to measure liver function non-invasively at the bedside. Other innovative technologies, based on the use of ICG-PULSION, are due to follow in the coming years. Once licences have been issued for ICG-PULSION in the remaining EU countries and the USA, there will be a marked increase in sales revenues generated by ICG-PULSION. It is difficult to predict how soon these approvals will be issued since it depends to a large extent on the speed at which each individual authority works. LiMON liver results in real-time LiMON makes it possible for the first time ever for liver function to be tested and monitored at the bedside. Previously liver function readings could only be taken from blood samples in the laboratory. LiMON offers several advantages over this static method. Via special single-use sensors, which are manufactured by PULSION, and which are attached to the finger or ear, LiMON measures the rate at which ICG-PULSION is being broken down and thereby provides a real-time reading of the liver function. LIMON could soon become the standard monitoring technology for liver operations. There are numerous applications: in intensive care, LiMON can be used in cases of impending sepsis or septic shock, and in internal medicine it opens up whole new fields for the diagnosis of liver disorders. LiMON provides continuous monitoring of liver function during surgical operations. Threatening complications can be identified quickly and the appropriate corrective measures taken. With the aid of LiMON, indications of possible liver failure can be recognised much earlier than is possible when other diagnostic methods are employed. As a result of positive experience gained from long years of clinical studies, the University of Vienna Hospital for Anaesthesiology and Intensive Care Medicine and the University of Vienna Hospital for Surgery now both employ LiMON as a routine measure during all liver transplant operations. Both hospitals are convinced that this has led to higher survival rates and a reduction in costs. LiMON technology is protected by 20 patents and patent applications. 10

11 02 Facts and figures 05 Foreword by the Management Board 07 Highlights Products and Technologies 12 Markets and business model 14 Investor Relations 15 Our Vision 16 Report of the Supervisory Board 19 Consolidated financial statements (U.S. GAAP) 20 Group Management Report 32 Consolidated balance sheet 34 Consolidated income statement 35 Consolidated cash flow statement 36 Consolidated statement of changes in stockholders equity 36 Consolidated analysis of non-current assets 38 Notes to the consolidated financial statements 58 Independent Auditors Report 59 Financial calender IC-VIEW monitoring blood supply whilst still in the operating theatre Equipped with a camera with a special infra-red laser light, IC-VIEW makes even the most minute blood vessels visible. Blood vessel deformities can also be easily diagnosed. IC-VIEW can also quantify and record details of the blood supply to tissues and organs. With the aid of this technology, surgeons can carry out an entirely new kind of visual check on the progress of their surgery whilst the operation is still being performed. An intravenous injection of ICG-PULSION is required as a fluorescent medium when using IC-VIEW. In July 2004 PULSION issued an exclusive five-year licence for IC-VIEW to Carl Zeiss. As a result, IC-VIEW will become available as a fully integrated optional extra in the new Carl Zeiss neurosurgical microscope, OPMI Pentero. Carl Zeiss, the worldwide market leader in the manufacture of surgical visualising systems, has plans to integrate IC-VIEW into other products in the future, thus making it available for other specialised fields of surgery. The licence arrangements, together with the commencement of our own dynamic strategy for surgical sales, have contributed greatly to the establishment of this technology on the worldwide market. PULSION has several patents and patent applications which protect IC-VIEW technology. IC-VIEW is of great importance to PULSION because, above all, it creates opportunities for further applications for ICG-PULSION. Thanks to the cooperation agreement with Carl Zeiss, IC-VIEW is becoming an integrated additional option for patient operation microscopy CeVOX early diagnosis and treatment in cases of sepsis Using a single-use fibre-optic probe, CeVOX carries out continuous measurements of the central venous oxygen saturation of pre-heart blood. This enables an assessment to be made of the state of the oxygen balance in the body, thus making it possible to recognise signs of impending sepsis at an early stage. CeVOX has the advantage over traditional methods of measurement that, if necessary, the probe can be introduced using the standard central venous catheter line which is already in position. Sepsis is the most common cause of death in intensive care patients, resulting in more fatalities than the combined figures for cancer of the breast, bowel, pancreas and prostate gland. Diseases associated with sepsis are on the increase and related annual cost to the health service in the USA alone amounts to approximately US dollar 17 billion. In a remarkable study published in the New England Journal of Medicine, the most authoritative medical journal, it was reported as early as 2001 that the mortality rate of patients with pre-sepsis syndrome can be reduced by 34 % and the length of hospitalization can be reduced by 3.8 days if continuous monitoring of pre-heart oxygen saturation is commenced at an early stage in the casualty department and an appropriate follow-on therapy is carried out. PULSION helps to achieve these results by offering CeVOX as the appropriate tool. By measuring the oxygen saturation of pre-heart blood, an impending sepsis can be recognised at an early stage. CeVOX should be instrumental in reinforcing our position as market leader in the field of minimally invasive physiological patient management and generating a significant increase in revenues from the sale of sterile disposable products. 11

12 Markets and business model Steady flow of sales revenue from disposable products Technology is our admission ticket PULSION develops, manufactures and markets innovative technologies which set the standard for systems used in medical diagnosis and therapy. These systems give doctors access to unique, reliable parameters which they can use to apply new and improved examination methods, to make swifter, more accurate diagnoses and to monitor patients without exposing them to excessive risks. However, the sale of patient monitors is not the sole aim of our business. The frequency of applications and hence the sales volume achieved with disposable products increases with the growing equipment base. Sales revenue is determined by the diversity of applications PULSION s business model combines medical technology, a medical preparation and sterile medical products. Whilst sales of patient monitors do generate some profits, their main function is to open the door to generate continuous business with disposables, covering the whole ranging from ICG-PULSION, via PiCCO catheter sets, through to LiMON sensors. PULSION s growth is mainly attributable to the increasingly wide range of applications for its technologies. It is therefore in a considerably stronger position than other manufacturers of medical technological equipment whose existence mainly depends on initial installations of equipment in hospitals and medical practices, investments in replacement items and technical services. Less than 20 % of our total sales revenue in the past financial year was generated by one-off revenues from licence issues and equipment sales, whereas the sales of disposable products and ICG-PULSION accounted for more than 80%. By gearing the business model towards meeting the continual demand for disposable products in medical practice, PULSION s business activities are only subject to slight fluctuations and remain largely unaffected by investment cycles in the health-care sector. We are committed to efficiency PULSION products are extremely efficient because they combine minimally-invasive methods of examination and monitoring with improved therapeutic options. This is very much in the interests of the various ever-expanding health-care markets throughout the world which are endeavouring to reduce costs. PULSION s products reduce both the cost of materials per operation and the manpower input of medical and nursing staff. In addition, monitoring systems which are simple to operate and minimally invasive reduce the frequency and severity of complications which result in higher costs. Many more untapped markets In 2004, 41 % of total sales revenue were generated in Germany where our main product-line, based on PiCCO-Technology, is already employed in most hospitals as the standard method for diagnosis and monitoring in intensive care medicine. Our next aim is to develop markets in Europe, the Asian-Pacific region and North America. Establishing our highly innovative products on the market always involves a number of steps. The first is to prove, with the aid of scientific studies and tests carried out in clinical practice, that PULSION technologies provide medical and economic advantages compared with other methods. The next step is for our equipment to prove its worth in trials carried out in leading hospitals recognised for their influence and high standards. Ultimately, in successive stages, hospitals will embrace our technologies as the general standard: this is the phase where our business model attains its full potential. All PULSION products are currently still at the beginning of their product life-cycles. Nevertheless, the Company is already showing signs of dynamic growth with an international presence of six sales subsidiaries. The Company has revolutionary technologies which, in certain areas, face no competition with a number of international licence agreements already in place. 12

13 02 Facts and figures 05 Foreword by the Management Board 07 Highlights Products and Technologies 12 Markets and business model 14 Investor Relations 15 Our Vision 16 Report of the Supervisory Board 19 Consolidated financial statements (U.S. GAAP) 20 Group Management Report 32 Consolidated balance sheet 34 Consolidated income statement 35 Consolidated cash flow statement 36 Consolidated statement of changes in stockholders equity 36 Consolidated analysis of non-current assets 38 Notes to the consolidated financial statements 58 Independent Auditors Report 59 Financial calender All-inclusive systems guarantee continuous business + + Equipment Disposable products ICG-PULSION One-time income from license and equipment sales already accounted for less than 20% of our total sales revenue in 2004 by contrast, more than 80% is generated by sales of disposable products and ICG-PULSION. The advantages: patent protection at several levels, additional protection in the form of system licences exclusive use of PULSION products Products and markets Emergency care CeVOX **** Surgery LiMON * IC-VIEW * PiCCO Intensive care PiCCO CeVOX **** LiMON * CiMON **** Ophthalmology ICG-PULSION Internal medicine LiMON * Intensive-care medicine is our core market. With new technologies, we are expanding this market to include emergency medicine and surgery. We are currently setting up and operating highly qualified sales organisations for these markets. *) LiMON and IC-VIEW both require ICG-PULSION ****) product not yet available on the market Products and market potential * PiCCO EUR 2,200 million LiMON ** *** EUR 277 million CeVOX ** **** EUR 140 million PULSION systems which are already in place in market have considerable future potential, which shall be exploited systematically over the coming years. IC-VIEW ** *** EUR 186 million CiMON ** **** EUR 170 million *) market potential on the basis of PULSION's own estimates (basis health care market 2004) **) estimates were only made for the USA and Europe ***) in relation to ICG-PULSION used ****) product not yet available on the market 13

14 Investor Relations Upward trend for PULSION stock The price of PULSION stock rose by more than 71% in In 2004, the market price for PULSION stock rose by more than 71 % from Euro 2.85 to Euro 4.88 (Basis: Xetra-index closing price). During the same period, the Prime Pharma & Healthcare Performance sector index rose by just 19% and the TecDAX fell by 4%. PULSION stock s performance was therefore significantly stronger than that of the market as a whole. The main factors behind this pleasing development were the sharp rise in sales revenue, a continually improving gross profit margin since the turnaround in mid-2003, and the conceivable reality that PiCCO-Technology will become the standard method for monitoring critically ill patients, thereby ensuring lasting growth for PULSION beyond any current market trends. The liquidity of PULSION stock, which is an important investment criterion, especially for institutional investors, more than doubled in the period under report. The daily trading volume rose from an average of 10,015 shares in 2003 to over 21,000 shares in This means a marked improvement in the tradability of PULSION stock and demonstrates that our efforts are coming to fruition. Better information for investors Investor Relations activities were further expanded in The objective of work in this area is to build up a good relationship with investors based on trust and to offer them the highest possible degree of transparency into the business, at a reasonable level of cost to the entity. The financial markets thirst for first-hand corporate information increased significantly during the period under report. PULSION made a very successful presentation at the Deutsche Eigenkapital- Forum (German Equity-Forum) in November 2004 and held six investor information days, or Roadshows, in Germany and Great Britain. In addition to the quarterly reports, shareholders were also provided with 14 press releases and 11 ad-hoc reports on important matters relating to the Group in We have also expanded the scope of our investor relations website in the Internet. PULSION stock has shown a long-term constant upwards trend, clearly performing better than the index. % PULSION AG Prime Pharma & Healthcare TecDax PULSION share performance in comparison to the Prime Pharma & Healthcare Performance Index and TecDAX (Basis: Xetra-index closing prices from Dec. 31, 2003 to Dec. 31, 2004) 14

15 02 Facts and figures 05 Foreword by the Management Board 07 Highlights Products and Technologies 12 Markets and business model 14 Investor Relations 15 Our Vision 16 Report of the Supervisory Board 19 Consolidated financial statements (U.S. GAAP) 20 Group Management Report 32 Consolidated balance sheet 34 Consolidated income statement 35 Consolidated cash flow statement 36 Consolidated statement of changes in stockholders equity 36 Consolidated analysis of non-current assets 38 Notes to the consolidated financial statements 58 Independent Auditors Report 59 Financial calender Good corporate governance is a duty PULSION expressly supports and gives its unqualified agreement to the international standards on the governance and supervision of listed companies set out in the German Corporate Governance Code, and considers them indispensable. In this way, we seek to satisfy the needs of shareholders, business partners and employees of a listed company up to the highest level possible. The only divergences made by PULSION from the Corporate Governance Code relate to the deductible for D&O (Directors and Officers ) liability insurance policy, the deadline for publication of interim reports and the individualized listing of Management and Supervisory Board compensation. Details of and the reasons for these divergences can be found in the Internet at Million shares 5,5 5,0 4,5 4,0 3,5 3,0 2,5 2,0 1,5 Key data on PULSION stock at December 31, 2004 ISIN-Code (previously WKN) DE (548790) Stock market abbreviation PUS Stock market segment Prime Standard Sector index Prime Pharma & Healthcare Performance Index Subscribed capital EUR 9,446,052 Bearer shares 9,446,052 Closing market price 2003* EUR 2.85 Closing market price 2004* EUR 4.88 Highest price (52 weeks)* EUR 4.97 Lowest price (52 weeks)* EUR 2.64 Market capitalisation (December 31, 2004)* EUR 46.1 million Earnings per share (diluted) 0.09 EUR *Xetra index closing price 1,0 0,5 0, The increasing liquidity of PULSION stock reflects the success of our investor relation work. Our Vision We are setting the standard for diagnostics and monitoring methods throughout the world PULSION develops innovative, minimally invasive systems for the diagnosis and monitoring of critically ill patients. Our focus is on vital organs and bodily functions. PULSION technologies reduce the risks to patients because only minimal intervention is required. They also help considerably to cut the cost of treatment because the time required by medical and nursing staff is reduced to a minimum. With the aid of new parameters, PULSION technologies enable more rapid and well-founded decisions to be made for therapies and also allow an immediate assessment of how successful the chosen therapy is. Hence, PULSION technologies are making their contribution towards achieving a significant reduction in treatment times. Intensive-care medicine is our core market. With new technologies, we are expanding this market to include emergency medicine and surgery. We are currently setting up and operating highly qualified sales organisations for these markets in the most important regions of Europe, Pacific Asia and the USA. Peripheral markets are reached mainly through cooperative agreements and dealer networks. It is our aim, as the technological leader in the field, to establish worldwide diagnostic standards, which will then be maintained and expanded with the aid of continuous research and development. In order to achieve this, we work in close cooperation with hospitals and institutes in countries at the forefront of medical technology. Our technological advantage is protected internationally by patents and patent applications. 15

16 Report of the Supervisory Board PULSION Medical Systems AG can report on a successful financial year The Group recorded a profit for the first time in 2004, made possible by a strict focus on core technologies, improved product margins and the implementation of a consistent cost policy, coupled with continued sales revenue growth. The Group reports a net profit of EUR 0.9 million for The improved cash flow situation meant that, as well as investing in items of capital expenditure, it was also able to reduce loans. The Company has thus succeeded in further strengthening its market position. During the financial year 2004, the Supervisory Board carried out all its tasks in accordance with the law and Company statutes and assured itself of the proper governance of the Company. We have monitored the activities of the Management Board on a regular basis and stood by it in an advisory capacity. This was based on numerous oral, telephonic and written reports provided by the Management Board. In five meetings, including one by telephone, the Management Board informed the Supervisory Board in detail of business policies, corporate planning, risks and the course of business of the Company. Any business transactions requiring approval were examined, discussed and authorized by the Supervisory Board. In addition, the Company has an Audit Committee which deals specifically with issues arising from the year-end audit. The main areas of focus of the Supervisory Board deliberations were sales revenue and earnings developments, mediumterm financing, the conclusion of further important cooperation arrangements and the alignment of the Company s risk policy to the future size of the enterprise. It also considered the strategic position of the Group s products and technologies and the future prospects of the Company and its subsidiaries. The Supervisory Board was kept informed in detail by the Management Board about the Group s overall position, including issues relating to the risk management system. The bookkeeping system, the U.S. GAAP consolidated financial statements, the annual statutory financial statements of PULSION Medical Systems AG, as well as the management reports of the Company and the Group for the financial year 2004 were audited by RSM Haarmann Hemmelrath GmbH, Wirtschaftsprüfungsgesellschaft Steuerberatungsgesellschaft Munich, elected by the Annual Shareholders Meeting as independent auditors, and received unqualified audit opinions. The financial statements and management reports for the AG and Group and the long-form reports of the auditors were submitted to all of the members of the Supervisory Board. In the meeting to approve the financial statements, the relevant documents were discussed in detail following the report of the auditors, and in the presence of the auditors. We have examined the financial statements and management reports for the AG and Group and the proposed appropriation of results. No objections were raised. We also concur with the result of the audit. The annual and consolidated financial statements prepared by the Management Board are thus approved and the annual financial statements adopted in accordance with 172 AktG (German Stock Corporation Act). We also endorse the proposed appropriation of results. There has been one change in the composition of the Supervisory Board during the past year. Dr. Walter Wenninger, Chairman, departed from the Supervisory Board with effect from November 30, 2004 and Claus F. Vogt joined with effect from December 1. Michael Bourjau, who was previously Deputy Chairman, took over the Chairmanship from Dr. Wenninger. The Chairman of the Management Board, Dr. Pfeiffer, resigned on March 15, 2005 with immediate effect. The Supervisory Board thanks Dr. Pfeiffer for his many years of service to the Group. PULSION s successful performance would not have been possible without the commitment of the employees of PULSION Medical Systems AG and its subsidiaries: the Supervisory Board thanks them all. The Supervisory Board also thanks the Management Board for the work performed and for its close cooperation. Munich, March 22, 2005 Michael Bourjau Chairman 16

17 02 Facts and figures 05 Foreword by the Management Board 07 Highlights Products and Technologies 12 Markets and business model 14 Investor Relations 15 Our Vision 16 Report of the Supervisory Board 19 Consolidated financial statements (U.S. GAAP) 20 Group Management Report 32 Consolidated balance sheet 34 Consolidated income statement 35 Consolidated cash flow statement 36 Consolidated statement of changes in stockholders equity 36 Consolidated analysis of non-current assets 38 Notes to the consolidated financial statements 58 Independent Auditors Report 59 Financial calender 17

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19 02 Facts and figures 05 Foreword by the Management Board 07 Highlights Products and Technologies 12 Markets and business model 14 Investor Relations 15 Our Vision 16 Report of the Supervisory Board 19 Consolidated financial statements (U.S. GAAP) 20 Group Management Report 32 Consolidated balance sheet 34 Consolidated income statement 35 Consolidated cash flow statement 36 Consolidated statement of changes in stockholders equity 36 Consolidated analysis of non-current assets 38 Notes to the consolidated financial statements 58 Independent Auditors Report 59 Financial calender Consolidated financial statements (U.S. GAAP) of PULSION Medical Systems AG as of December 31, Group Management Report Summary Financial report 21 General economic conditions and market 21 Revenue trends 23 Earnings 23 USA 23 Assets, liabilities and financial position 25 Capital expenditure 25 Production and purchasing 25 Research and development 26 Employees 26 Patents and approvals 26 Environmental care and quality management 26 Corporate Governance 27 Events after the balance sheet date Risk report 27 Risk management system 27 Market and competition 28 Product liability 28 Growth and financing 28 Approvals 28 Dependence on suppliers 28 Credit risk 28 Patents and intellectual property 29 Personnel 29 Warehousing and transportation 29 Protection from loss of confidential information 29 Subsidiaries 29 Litigation Forward-looking report 30 Prospects Long-term Strategy 32 Consolidated balance sheet 34 Consolidated income statement 35 Consolidated cash flow statement 36 Consolidated statement of changes in stockholders equity 36 Consolidated analysis of non-current assets 38 Notes to the consolidated financial statements 58 Independent Auditors Report 59 Financial calender 19

20 Group Management Report Summary In 2004, PULSION (PULSION Medical Systems AG) succeeded in strengthening its position as an innovative supplier of minimally invasive diagnostic and monitoring systems to improve and simplify the management of treatment and care in critically ill patients. The turn-around achieved in the second half of 2003 resulted in 2004 being a successful year. Due to the better than expected performance, the Company was able, on November 8, 2004, to double the forecast for the operating profit (EBIT) from EUR 0.5 million to EUR 1.0 million; it is now able to report that even this forecast figure has been surpassed. The following major milestones were reached during the past year: Expansion of the CeVOX product range PULSION has now presented its fourth technology platform CeVOX, a minimally invasive system for continuous monitoring of the oxygen saturation in the bloodstream and plans to commence with marketing activities during the first quarter of Exclusive licence agreement with Carl Zeiss for IC-VIEW technology Carl Zeiss will integrate PULSION s IC-VIEW technology into its surgical microscope for the intraoperative visualisation of blood vessels. This will significantly increase the technology's market penetration and bolster sales of ICG-PULSION. ICG-PULSION receives approval in key EU countries Following the positive result of the EU reciprocal approval proceedings to recognise ICG-PULSION in Belgium, Ireland, Italy, the Netherlands, Austria, Portugal and Sweden, it will soon be possible to commence marketing activities in these countries once local marketing permission has been received. PiCCO connected up with GE Healthcare and Spacelabs patient monitoring systems A significant step has been made towards PiCCO-Technology becoming universally accessible by linking PiCCO-Technology to patient monitoring systems made by GE Healthcare and Spacelabs; the relevant products will be available for use in This development is a clear demonstration of PiCCO s importance in the area of acute medicine. In spite of the recent economic development of the world s leading industrial countries, PULSION continued to grow strongly, and thus provide clear evidence of the sustainability of its innovative business model. Sales revenue amounted to EUR 16.3 million, an increase of EUR 2.6 million compared to the previous year. This 19 % increase was all achieved through organic growth. Excluding the one-off income generated by technology licensing agreements, sales revenue grew by 22 %. At an EBIT level, the result turned round from a loss EUR 0.4 million in 2003 to a profit of EUR 1.2 million in The net result for the year turned round from a consolidated net loss of EUR 0.7 million to a consolidated net income for the year EUR 0.9 million. Cash flow from operating activities increased during the year under report to EUR 2.2 million, an increase of 165 % compared to the previous year s figure of EUR 0.8 million. After taking account of the cash outflows from investing activities (EUR 1.5 million) and financing activities (EUR 0.8 million), cash and cash equivalents fell slightly during 2004 from EUR 4.6 million to EUR 4.5 million. 20

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