Novo Resources Annual Report 2008

Plain-text annual report

N o v o N o r d i s k A / S A n n u a l R e p o r t 2 0 0 8 Financial, social and environmental performance Our focus is our strength P h 2 F S D O B G G S R R A O O N E C F L O O O O R C N E W R C E E E N S D C M * * S Performance highlights 2008 2008 2007 Change Financial performance Sales total Diabetes care Of which modern insulins Biopharmaceuticals Gross proﬁ t Gross margin Sales and distribution costs Research and development costs Research and development costs excl AERx® *) Administration expenses Operating proﬁ t Operating proﬁ t excl AERx® *) Net proﬁ t Effective tax rate Capital expenditure Free cash ﬂ ow Long-term ﬁ nancial targets Operating proﬁ t growth Operating proﬁ t growth excl AERx® *) Operating margin Operating margin excl AERx® *) Return on invested capital (ROIC) Cash to earnings (three-year average) Non-ﬁ nancial performance Employment impact worldwide Water consumption Recycling percentage (waste) CO2 emissions Employees Employee turnover rate Engaging culture (employee engagement) New patent families (ﬁ rst ﬁ ling) Share performance Dividend per share (proposed) Closing share price (B shares) Market capitalisation (B shares) **) DKK million DKK million DKK million DKK million DKK million % % of sales % of sales % of sales % of sales DKK million DKK million DKK million % DKK million DKK million % % % % % % Number of jobs 1,000 m3 % 1,000 tons FTE % Scale 1–5 Number 45,553 33,356 17,317 12,197 35,444 77.8 28.2 17.2 16.5 5.8 12,373 12,698 9,645 24.0 1,754 11,015 38.4 23.7 27.2 27.9 37.4 97.6 88,500 2,684 51 215 26,575 12.1 4.2 71 DKK DKK DKK billion 6.00 271 135 **) Excluding non-recurring costs related to discontinuation of all pulmonary diabetes projects. **) Novo Nordisk B shares (excluding treasury shares). See more ﬁ nancial and non-ﬁ nancial highlights on pp 16–17. 41,831 30,478 14,008 11,353 32,038 76.6 29.6 20.4 17.2 6.0 8,942 10,267 8,522 22.3 2,268 9,012 (1.9) 12.6 21.4 24.5 27.2 87.0 81,600 3,231 38 236 25,516 11.6 4.1 116 4.50 335 172 9% 9% 24% 7% 11% 38% 24% 13% (23%) 22% 8% (17%) (9%) 4% (39%) 33% (19%) (22%) About Novo Nordisk’s annual reporting Novo Nordisk is the world leader in diabetes care and has leading positions within haemosta- sis management, growth hormone therapy and hormone replacement therapy. The company also has an ambition to build a strong platform within inﬂ ammation. With over 27,000 employees in 81 countries, Novo Nordisk manufactures and markets pharmaceutical products and services that make a signiﬁ cant differ- ence to patients, the medical profession and society. This is the ﬁ fth consecutive year of reporting on the company’s ﬁ nancial and non-ﬁ nancial perform- ance in one inclusive document, the Annual Report, covering the ﬁ scal year 2008. The report discusses key challenges and strategic initiatives to develop the business in order to meet targets and sustain long- term value creation. It also explains Novo Nordisk’s way of doing business as a values-based company guided by a vision. The feature articles present company-driven activities in pursuit of the Novo Nordisk Vision and respond to concerns identiﬁ ed through interactions with shareholders, ﬁ nancial analysts and other stakehold- ers during the year. External opinion leaders have been invited to con- tribute their perspectives on some of the key issues: the current economic climate, challenges in the healthcare industry and marketplace, new treatment paradigms for diabetes care and the interrelationship of the global climate change and a healthy future. Designed to meet the information needs of share- holders, ﬁ nancial analysts and other corporate stakeholders, the report seeks to support business performance and enhance shareholder value by exploring the interactions between ﬁ nancial and non-ﬁ nancial objectives. Novo Nordisk is in compliance with applicable corporate governance codes and follows current international standards for mandatory and voluntary reporting: • International Financial Reporting Standards (IFRS). • AA1000 Assurance Standard (2003). • US Sarbanes–Oxley Act requirements for docu- menting and reporting on the effectiveness of internal controls for ﬁ nancial reporting. Novo Nor- disk embarked in 2008 on a process of structuring the control environment for non-ﬁ nancial data with the aspiration to have full alignment with the control environment for ﬁ nancial data. • The accountability standard, the AA1000 Frame- work. • Global Reporting Initiative (GRI) G3 Sustainability Reporting Guidelines. • UN Global Compact, Communication on Progress. In the absence of global standards for inclusive re- porting, the Annual Report is prepared in respect of current best practice for ﬁ nancial and non-ﬁ nancial reporting, respectively. This includes applying the principles of materiality, completeness and respon- siveness. Novo Nordisk has chosen to apply the term ‘non- ﬁ nancial reporting’ to performance on sustainability- driven issues. Hence, the Annual Report includes both ﬁ nancial statements and non-ﬁ nancial state- ments, while the narrative parts of the report present the company’s performance from an inclusive perspective. The accuracy, completeness and reliability of the company’s reporting is veriﬁ ed through internal controls, assurance and independent audits. The Annual Report 2008 includes the ﬁ nancial statements of the parent company, Novo Nordisk A/S (see pp 105–112), and is issued in February 2009 for approval by shareholders at the Annual General Meeting on 18 March 2009. It is subse- quently ﬁ led with the Danish Commerce and Com- panies Agency. In addition, a Form 20-F Report for 2008 is ﬁ led with the United States Securities and Exchange Commission in February 2009. These two public ﬁ lings contain references and links to information posted on the Company’s website; such information is not incorporated by reference into the public ﬁ lings. Additional reporting online provides more back- ground, context and data. Many sections of this report reference additional online information and an index on p 116 provides links to online content at annualreport2008.novonordisk.com. or- ring the e- ty ess. - of al n- ity- - sent k m- for d nks d t at Charlotte Lucas Østerlund expresses the full effect of living with diabetes at the 2008 meeting of the European Association for the Study of Diabetes in Rome. Fifteen Novo Nordisk employees marked World Diabetes Day in Denmark by running a marathon from the company’s headquarters, past several company sites, to the Changing Diabetes® Village in the centre of Copenhagen, Denmark. Welcome to Novo Nordisk Pages 2–7 2 Our focus is our strength 4 Managing in the current economic climate 6 Novo Nordisk at a glance Business results Pages 8–19 8 Performance in 2008 15 Outlook for 2009 16 Financial highlights 17 Non-ﬁ nancial highlights 18 Pipeline progress Business environment Pages 20–29 20 Doing business the Novo Nordisk Way 21 Values drive performance 22 Pursuing a focused strategy 24 Managing risks 26 Universal principles guide action 27 Diversity supports global growth 28 Strengthening environmental management Diabetes care Pages 30–37 30 Changing diabetes is possible 32 Supporting individualised treatment options 34 Setting an agenda for change 36 Ensuring access to care Biopharma- ceuticals Pages 38–41 38 Focusing on strengths in biopharmaceuticals 40 Living with haemophilia 41 Changing possibilities for people with haemophilia Shareholder information Pages 42–50 42 Corporate governance 44 Executive remuneration 46 Board of Directors 48 Executive Management 49 Shares and capital structure Consolidated ﬁ nancial and non-ﬁ nancial statements 2008 Pages 51–104 51 Consolidated ﬁ nancial and non-ﬁ nancial statements 52 Consolidated ﬁ nancial statements 89 Consolidated non-ﬁ nancial statements Pages 105–112 105 Financial statements of the parent company Pages 113–115 113 Management statement 114 Auditor’s reports Additional information Page 116 and inside back cover 116 Index • Contacts • References • Novo Nordisk key products Novo Nordisk Annual Report 2008 1 Welcome to Novo Nordisk Our focus is our strength Our focus is our strength The year 2008 is likely to be remembered by many as the year when, like a ﬂ ash of lightning, a severe economic crisis brought an end to the belief in uninterrupted growth. The globalisation we have witnessed in recent years, which has had many positive effects, suddenly showed another face: no nation, no company and no individual is unaffected by the economic downturn. Busi- nesses, large and small, are in crisis. Some that were considered icons in their industries no longer exist. Against such a backdrop it is with great humility, but also with pride and satisfaction, that we can report on a year that has been very positive for Novo Nordisk, demonstrating the results of our focused business approach. We increased sales by 12% (mea sured in local currencies) and our reported operating proﬁ t by 38%. Our investment in research and development resulted in a strengthened pipeline of new products. And we continued to optimise processes and globalise our sales and production activities, which makes our organisation even better prepared for challenges in coming years. One of the reasons why Novo Nordisk came through 2008 in better shape than many other companies is that we produce lifesaving medicines. Our customers, particularly people with chronic conditions, require treatment during recessions as well as periods of economic prosperity. But a great deal of our success is attributable to our more than 27,000 Novo Nordisk colleagues who have once again delivered excellent results. With doctors and patients, in the laboratories, in production, in administration and throughout our value chain, there has been a focus on achieving results for all stakeholders both in the short and long term. Innovation boosts competitiveness Innovation in our pipeline is the source of long-term competitive- ness in our industry, and in this area 2008 was very eventful. Not everything has worked out as planned. In early 2008, we discontinued our attempts to develop inhalable insulin. Later in the year we had to reconcile ourselves to the fact that the effect of NovoSeven® for treatment of acute bleeds in trauma could not be proven in controlled clinical trials within the foreseeable future. We also decided to discontinue trials to investigate the beneﬁ ts of growth hormone therapy for dialysis patients because of the difﬁ culty in recruiting trial participants. Liraglutide has the potential to improve the treatment of type 2 dia betes. Even though requirements for approval of new medicines have become increasingly challenging, we are cautiously optimistic about the ﬁ nal outcome of regulatory assessment. We currently an- ticipate regulatory approval in the US and some European countries in 2009, followed by Japan and a number of other countries in 2010. We know that even the best insulins available in the market today are not perfect. Phase 2 results for the company’s new generation of insulins have demonstrated that long-acting insulins and insu- lins with a combined short- and long-acting effect can be further improved. If preliminary results are conﬁ rmed by additional trials, this new generation of insulins has the potential to offer better treatment for people with diabetes and to strengthen Novo Nor- disk’s competitive position. In 2008, we decided to focus our biopharmaceutical research efforts in haemostasis, growth disorders and inﬂ ammation. Re- search in inﬂ ammation will be conducted by our Danish research organisation and a newly established research centre for inﬂ am- mation in Seattle, US. Collaboration with a number of biotech companies also plays a signiﬁ cant role in our ability to bring new products to market in this area. In 2008, Novo Nordisk made two signiﬁ cant breakthroughs that may have great impact on future diabetes treatment. International expansion supports growth In the diabetes market we have maintained our position as the world leader with a market share of more than 50% by volume. Demand for our products has increased and we see a continu- ing transition from traditional human insulin to modern insulins. Novo Nordisk won market share for modern insulins in 2008 and remains the only company with a full portfolio of short-acting, mixed and long-acting insulins. To expand our competitive posi- tion and brand awareness, not least among general practitioners, we have expanded our sales organisation in several key markets. However, 2008 will mostly be remembered as the year in which Novo Nordisk made two signiﬁ cant breakthroughs that may have great impact on future diabetes treatment. The development of liraglutide for the treatment of type 2 diabetes was ﬁ nalised and regulatory approval was sought in the US, Europe, Japan and many other countries. In addition, a new generation of insulins for both type 1 and type 2 diabetes showed promising results in phase 2 trials. In November, we laid the foundation stone for a major expansion of our production site in Tianjin, China, which will create 500 new jobs. The new insulin formulation and ﬁ lling plant is one of the largest investments in the history of Novo Nordisk and our biggest single investment outside Denmark. The second-largest single investment, the production site in Montes Claros, Brazil, became fully operational in 2008 and today provides insulin to a number of markets. 2 Novo Nordisk Annual Report 2008 Welcome to Novo Nordisk Our focus is our strength Sten Scheibye, chairman of the Board of Directors, and Lars Rebien Sørensen, president and chief executive ofﬁ cer. Managing responsibly Many readers of this Annual Report will know that Novo Nordisk is managed using the Triple Bottom Line business principle. We assess our performance from three perspectives: ﬁ nancial, social and environmental. As we see it, a business can only be sustain- able in the long term if it meets stakeholders’ expectations in relation to all three aspects. In this report we provide examples of how we conduct our activi- ties in ways that are socially and environmentally responsible. We think a couple of them deserve particular mention. In November, we announced a new programme to offer diabetes treatment, including free insulin, to 10,000 children in some of the world’s poorest countries. This is part of a ﬁ ve-year programme called ‘Changing the Future for Children with Diabetes’, which begins in 2009. In addition to making free insulin available to a par- ticularly vulnerable population of people with diabetes, the project will also build long-term solutions for distribution of insulin and sustainable diabetes treatment in the world’s poorest countries. We are well on our way to achieving the ambitious target for CO2 reduction we set for ourselves in 2006 and, as a result of our efforts, the majority of our future electricity supplies will be gen- erated from wind. Just as the ﬁ nancial crisis is global, so is climate change, and everyone must take responsibility for addressing it. We will leave it to the scientists to debate to what extent climate change is human-induced or caused by natural developments that are not related to human activity. There are, however, many reasons, including ﬁ nancial, for managing a business in a way that minimises environmental impact, and we will retain our focus on this in coming years. Challenges ahead The pharmaceutical industry today is faced with a number of chal- lenges that have certainly not diminished with the current global recession. life-saving medicines. The increasing prevalence of chronic disease is already a major ﬁ nancial burden with treatment costs putting pressure on healthcare budgets, even in wealthy countries. It will be a huge challenge to ﬁ nance public health systems in the future in a way that makes it attractive to bring new and improved medi- cines to market and at the same time secure equal access to care. It is well known that new medicines are needed to improve the treatment of many diseases, but it is also evident that public healthcare providers and insurance companies are subjecting the costs versus the beneﬁ ts of new medicines to increased scrutiny. At the same time, increasing requirements to document potential long-term side effects make bringing new treatments to market even more costly. These challenges impact the outlook for the entire industry. At Novo Nordisk we are, however, optimistic about the future. With our focus on diabetes care and biopharmaceutical niche products, we believe that we are uniquely placed. We also believe our unique market position justiﬁ es further investment in our research and development and in expanding our international organisation and global supply through controlled growth and with continued focus on ﬁ nancial results. We would like to take this opportunity to thank our customers, shareholders and partners for their trust in Novo Nordisk during 2008. We also thank everyone at Novo Nordisk for their great efforts, creativity and engagement, which is the heart of our organisation and the foundation of the strong results presented in this report. Lars Rebien Sørensen Sten Scheibye We believe that the current economic downturn will impair societies’ and individuals’ ability to pay for healthcare, including President and chief executive ofﬁ cer Chairman of the Board of Directors Novo Nordisk Annual Report 2008 3 Welcome to Novo Nordisk Managing in the current economic climate Managing in the current economic climate Interview with Novo Nordisk’s CFO, Jesper Brandgaard In your opinion, what impact will the current economic downturn have on the pharmaceutical industry? We have to recognise that this crisis is not only global, it is severe, and it is likely to be of signiﬁ cant duration. There are pro- found implications for wealth and growth throughout the world. Even in a sector less impacted by short-term economic swings, such as the pharmaceutical sector, there is a clear correlation between long-term economic growth at the societal level and growth opportunities for companies. We believe the pharmaceutical sector will ﬁ rst see an impact in economies that are largely dependent on exporting either goods or raw materials. Oil price volatil- ity is, of course, important in this regard. Societies such as Russia, Algeria and Ven- ezuela may experience an impact on their ability to procure advanced pharmaceut- ical products. In many countries, notably in Europe, pressure to reduce the growth of public spending for pharmaceutical products will increase, with more substitution of ge- neric products. There will also be greater emphasis on health economics to make sure that products paid for by society are achieving the desired health outcomes. With the new administration in Washing- ton, there is a high likelihood that 2009 will bring price reform in government- funded healthcare programmes such as Medicaid and Medicare. We have said that there has been an advantage for the industry from the migration of patients from Medicaid to the Medicare Part D programme and we did not think this was sustainable. The details of a potential pric- ing reform remain to be seen, but we do anticipate changes in some of the schemes funded by the federal government, includ- ing Medicare Part D. In the private health insurance market in the US, we are also looking at a scenario where funds are getting tighter. Patients 4 Novo Nordisk Annual Report 2008 are likely to face higher co-payments. Ev erything else being equal, it will be increasingly difﬁ cult to obtain reimburse- ment for new, advanced treatments. How do you see the ﬁ nancial crisis impacting the structure of the industry? There is still a profound need for large pharmaceutical companies to acquire innovation. These companies are gene r- ating signiﬁ cant positive cash ﬂ ows but are challenged by lack of innovation and regulatory hurdles. At the same time, small biopharm companies that do not yet have products on the market will have increas- ing difﬁ culty accessing long-term venture capital. These ﬁ rms are likely to either look for opportunities to partner with larger ﬁ rms or put themselves up for sale. In this environment, we expect to see consolida- tion in the industry. We have not changed direction; we have stayed the course, and we believe this will now present us with new opportunities. How was Novo Nordisk impacted by market volatility in 2008? While Novo Nordisk has continued to have strong sales and cash ﬂ ow and has not experienced any liquidity issues, recent market turmoil has had a bigger impact on the composition of Novo Nordisk’s share- holder base than we originally anticipated. Novo Nordisk’s largest shareholder con- tinues to be The Novo Nordisk Foundation through the Novo A/S holding company. The Foundation has bylaws stating that its primary objective is to be a stable owner of the Novo Group companies, including Novo Nordisk. Beyond the Foundation, we have experienced changes in the holdings of other large investors, notably US inves- tors repatriating funds. We have also seen a number of Danish pension institutions reducing their hold- ings in Novo Nordisk in order to maintain portfolio diversiﬁ cation. The challenge in the Danish stock exchange environment is that the relative performance of Novo Nor- disk compared with other companies listed on NASDAQ OMX Copenhagen increased Novo Nordisk’s weighting on the exchange dramatically during 2008. So we have seen the shareholdings of some of the company’s largest investors reduced. At the same time, we have seen solid support from new European and US investors, as well as from retail invest- ors in Denmark. These changes have not impacted the way the company interacts with the equity market, but have highlighted the need to be very transparent. How does Novo Nordisk manage its balance sheet, and have there been recent changes in direction? Historically, Novo Nordisk, like most pharmaceutical and large-cap biopharm ﬁ rms, has had a balance sheet with little debt. In fact, Novo Nordisk has operated with slightly positive net ﬁ nancial assets on its balance sheet. This is an advantage because having access to cash can now provide us with interesting investment possibilities. We have not changed direc- tion; we have stayed the course, and we believe this will now present us with new opportunities. In terms of cash returned to shareholders, Novo Nordisk has adhered to its dividend policy of gradually increasing the payout ratio to a level around the pharma industry average, which is now approximately 40%. Welcome to Novo Nordisk Managing in the current economic climate What impact did exchange rate ﬂ uctuations have on the company in 2008? One obvious example of the impact that currency developments had on Novo Nordisk in 2008 was the impact on sales growth. In 2008, Novo Nordisk achieved sales growth of 12% when adjusted for the impact of currencies. However, in re- ported terms sales growth was 9% due to negative exchange rate impact compared to the Danish kroner of approximately 3%, or more than 1 billion kroner. For a company with global operations like Novo Nordisk, extreme volatility requires that we be ever more transparent in our disclosures. In the longer term, it also requires that we continue to make invest- ments globally that help to balance our long-term currency exposure. A good example of this is the 400 million US dollar investment the company com- mitted to make in China in 2008 for a new production facility. Beyond the attractive- ness of the project in a growing market, the investment will help provide Novo Jesper Brandgaard, chief ﬁ nancial ofﬁ cer. Nordisk with a better balance between the company’s income base and cost base. In addition, the more assets the company has in China, the easier it becomes to attract local talent. Are there lessons that Novo Nordisk has learned from previous economic downturns that apply to the current situation? Previous downturns we’ve seen in recent years have been conﬁ ned to speciﬁ c regions, such as the Asian currency crisis in the late 1990s. The current downturn is likely to turn into a global recession with wide-ranging implications, some of which will be difﬁ cult to predict. Cautious spending behaviour combined with a willingness to invest in markets with long-term growth prospects will continue to be the cornerstones of Novo Nordisk’s strategy. In the longer term, this approach, along with a commitment to managing responsibly, has proven to be integral to the sustainable business model that the company is pursuing. Fareed Zakaria Editor, Newsweek International Novo Nordisk invited Fareed Zakaria to provide his perspective on the global economy. A problem of growth I would argue that the current economic crisis is a problem of growth, created by 124 countries growing simultaneously and by the fact that you have a single world economy in which everyone is partici- pating, so Chinese savings can fuel US consumption and vice versa. The most important real world effect we have to worry about is countries turning inward. The possibility of turning away from the single, global market, away from the idea that we can create a greater degree of global prosperity and raise stan- dards of living. The challenge for a company like Novo Nordisk is to explore whether it can play a role in trying to keep the Western world open. The challenge for a company like Novo Nordisk is to explore whether it can play a role in trying to keep the Western world open. This is a path most corporations have steered away from because they don’t want to get politically involved. Dr Fareed Zakaria is editor of Newsweek International, host of CNN’s Fareed Zakaria GPS, and co-host of PostGlobal, an online discussion of international issues. Novo Nordisk Annual Report 2008 5 Welcome to Novo Nordisk Novo Nordisk at a glance Novo Nordisk at a glance Novo Nordisk is a focused healthcare company and a world leader in diabetes care. Key market ﬁ gures for the diabetes care business are provided here and on p 10. In its other business segment, biopharmaceuticals, Novo Nordisk has a leading position within the therapeutic areas of haemostasis management, growth hormone therapy and hormone replacement therapy. The company reports biopharmaceutical sales globally and by therapy area. See pp 10–11 for more information. North America International Operations Europe Sales: 33% of total sales. Sales: 19% of total sales. Sales: 38% of total sales. Insulin/modern insulin volume share: 42% of the total market; 33% of the segment. Insulin/modern insulin volume share: 57% of the total market; 57% of the segment. Insulin/modern insulin volume share: 55% of the total market; 51% of the segment. Performance: The number of people with diabe- tes in the US is now 24 million, according to the national Centers for Disease Control (CDC), and this is projected to exceed 30 million within 10 years. The rate of new cases of diabetes soared by about 90% in the past decade, according to the CDC, fuelled by growing obesity and sedentary lifestyles. Novo Nordisk sees significant opportunities to improve care and treatment for people with diabetes in the US. To deliver on these oppor- tunities, market access is crucial. More than 80% of the US population is currently covered by medical insurance. Novo Nordisk’s products are eligible for reimbursement through 90% of managed care formularies, a key competitive advantage. Performance: Novo Nordisk’s International Operations – covering South and Central America, the Middle East, Africa and Asia (excluding Japan & Oceania) – is a vast area representing 85% of the world’s population and 80% of all people with diabetes. Lack of access to adequate diabetes care is a con- tinuing concern in these countries, although there are encouraging signs that diabetes is rising on the public health agenda. A growing middle class in emerging markets such as China and India are also better able to afford more advanced treat- ments. The dramatic rise in the number of people with diabetes in these markets is driven by several factors, including urbanisation, an ageing popu- lation, unhealthy eating habits and sedentary lifestyles. Performance: Modern insulins are driving growth in the company’s European operations. Levemir®, the company’s basal insulin, is reinforcing Novo Nordisk’s market leadership in the region. Through its afﬁ liates, Novo Nordisk is driving home the message that changing diabetes care begins with raising awareness and working with partners. In Italy, Novo Nordisk supported a meeting of about 200 diabetes experts, policy-makers, patient representatives, industry and media to discuss how to stop the epidemic growth of diabetes. Marking its 50th anniversary, Novo Nordisk’s afﬁ liate in Germany held its second Camp D for young people with diabetes in 2008. Nearly 700 young people attended the four-day event, which focuses on enhancing quality of life for people with type 1 diabetes. Capacity-building: 89,500 healthcare profes- sionals have been trained or educated through Novo Nordisk’s National Changing Diabetes® programmes. Capacity-building: 151,500 healthcare profes- sionals have been trained or educated through Novo Nordisk’s National Changing Diabetes® programmes. Capacity-building: 79,000 healthcare profes- sionals have been trained or educated through Novo Nordisk’s National Changing Diabetes® programmes. 6 Novo Nordisk Annual Report 2008 Production sites Bagsværd, Denmark Chartres, France Clayton, North Carolina, US Dely Brahim, Algeria Gentofte, Denmark Hillerød, Denmark Hjørring, Denmark Kalundborg, Denmark Koriyama, Japan Køge, Denmark Mexico City, Mexico Montes Claros, Brazil Måløv, Denmark Tianjin, China Værløse, Denmark R&D facilities Bagsværd, Denmark Beijing, China Gentofte, Denmark Hillerød, Denmark Måløv, Denmark Seattle, Washington, US Clinical development centres Beijing, China Princeton, New Jersey, US Tokyo, Japan Zurich, Switzerland Regional and business area ofﬁ ces Afﬁ liates Representative ofﬁ ces Japan & Oceania Sales: 10% of total sales. Insulin/modern insulin volume share: 71% of the total market; 61% of the segment. Performance: Recognition of the need for bet- ter screening and earlier diagnosis of diabetes and other chronic diseases prompted a move by Japanese authorities in 2008 to establish a health- screening programme for adults ages 40–74, or 45% of the population, which will include a check of HbA1c or blood glucose levels. Levemir® is helping drive Novo Nordisk’s long- standing market leadership in Japan, where it was introduced in 2007 and has had the fastest penetration among the company’s major markets, owing to an aggressive and tightly focused launch, as well as its high acceptance among physicians and patients. While there has been increased competition, not least in the area of devices, Novo Nordisk’s products and devices continue to hold a strong position in Japan. Capacity-building: 60,000 healthcare profes- sionals have been trained or educated through Novo Nordisk’s National Changing Diabetes® programmes. 50 40 30 20 10 0 Sales by geographical area DKK billion 2004 2005 2006 2007 2008 Europe (cid:116) North America (cid:116) International Operations (cid:116) Japan & Oceania Welcome to Novo Nordisk Novo Nordisk at a glance Innovation and growth Novo Nordisk was created in 1989 from the merger of two companies founded in the 1920s that independently pioneered several breakthroughs in diabetes care. Both companies focused on treating the whole person and not just diabetes symptoms, and this approach continues to be a hallmark of Novo Nordisk’s business. The company has experienced signiﬁ cant growth in recent years, with total sales increasing by 119% since 2000. In the same period, the number of Novo Nordisk employees almost doubled to more than 27,000 in 81 countries. The milestones below highlight the company’s recent innovations and growth. 1996 NovoSeven® – for the treatment of haemophilia patients with inhibitor reaction – is launched. 1998 Activelle® (Activella® in the US) – the ﬁ rst low-dose continuous-combined oral HRT for postmenopausal women – is introduced. 1999 NovoRapid® (NovoLog® in the US) – the company´s ﬁ rst modern insulin, a rapid-acting insulin analogue – is marketed. Modern insulins are designed to better mimic the normal insulin response to changes in blood sugar levels. 2000 The company’s enzymes business is spun off as a separate company, Novozymes A/S. 2001 NovoRapid® FlexPen® is marketed. FlexPen® is a new preﬁ lled pen, designed for easy and discreet use. 2002 NovoMix® 30 – a dual-release modern insulin – is introduced. 2003 Norditropin NordiFlex® – the world’s ﬁ rst preﬁ lled growth hormone pen – is launched. 2004 Levemir® – a long-acting modern insulin – is launched. 2007 In Montes Claros, Brazil, Novo Nordisk inaugurates its largest insulin production facility outside Denmark. See more at novonordisk.com/about_us/ history/milestones_in_nn_history.asp. Novo Nordisk Annual Report 2008 7 Business results Performance in 2008 Performance in 2008 Novo Nordisk continued on a sustain- able growth path in all its major busi- ness areas and delivered solid results in 2008. Sales increased by 12% measured in local currencies and by 9% in Danish kroner. Modern insulins continued to be the main contributor to growth increasing by 28% in local currencies (24% in Danish kro- ner), and NovoSeven® and Norditropin® also continued to contribute to growth, increasing, respectively, by 14% in local currencies (9% in Danish kroner) and 12% in local currencies (10% in Danish kroner). Sales growth was realised in all regions measured in local currencies. The main contributors to growth were North Amer- ica and International Operations, which contributed 48% and 29%, respectively, of total sales growth. Europe contributed 21% and Japan & Oceania 2% of total sales growth in 2008, measured in local currencies. The gross margin increased to 77.8% in 2008, up from 76.6% in 2007, reﬂ ecting an improvement of 1.2 percentage points, primarily driven by sustainable productivity improvements. Costs related to research and development decreased by 8%; however, when adjusted for non-recurring costs related to the closure of all pulmo- nary diabetes projects in 2007 and 2008, research and development costs increased by 4%. This reﬂ ects a sustained high level of investment in research and develop- ment activities supporting the future growth of the company. Operating proﬁ t in 2008 increased by 38% to DKK 12,373 million compared to 2007. Net proﬁ t increased by 13% to DKK 9,645 million. When adjusted for the non-recur- ring income from the divestment in 2007 of Dako A/S’s business activities and the non-recurring costs related to the closure of all pulmonary diabetes projects, net proﬁ t increased by 22%. 8 Novo Nordisk Annual Report 2008 Earnings per share (diluted) increased by 16% to DKK 15.54. 2008 performance on long-term ﬁ nancial targets Focusing on growth, proﬁ tability, ﬁ nan- cial return and generation of cash, the four long-term ﬁ nancial targets guide the Sales by therapy area DKK billion 2004 2005 2006 2007 2008 Diabetes care (cid:116) Haemostasis management (NovoSeven®) (cid:116) Growth hormone therapy (cid:116) Hormone replacement therapy (HRT) (cid:116) Other products Sales growth Local and reported rates % 50 40 30 20 10 0 30 25 20 15 10 5 0 2006 2005 2004 (cid:116) In DKK as reported (cid:116) In local currencies 2007 2008 company’s ﬁ nancial development, aimed at ensuring a focus on shareholder value creation. These targets are operating proﬁ t growth, operating margin, return on invested capital and cash conversion. By 2008, Novo Nordisk reached the perform- ance level stipulated in the four long-term ﬁ nancial targets which were outlined in 2006. The four ratios are still considered an appropriate way to ensure value creation, and several of the targets have consequent- ly been increased. The revision is based on an assumption of a continuation of the current business environment and given the current scope of business activities and has been prepared assuming that currency exchange rates remain at current levels. Operating proﬁ t growth was realised at 38%. However, adjusted for non-recurring costs related to the closure of all pulmo- nary diabetes projects and a negative currency impact, the underlying operating proﬁ t increased by more than 25%. The long-term target is an average annual growth of 15%. The performance reﬂ ects solid underlying sales growth as well as an improved gross margin. The operating margin for 2008 was realised at 27%, up from 24.5% in 2007 adjusted for non-recurring costs related to the closure of AERx®, and exceeds the long-term target of 25%. The improve- ment in operating margin is driven by an improved gross margin. The return on invested capital was 37%, signiﬁ cantly up compared to 2007 and now exceeding the long-term target of 30%. The improvement mainly reﬂ ects solid growth in operating proﬁ t as well as a lower level of invested capital primarily due to a reduction in the ﬁ xed asset base. The cash to earnings ratio was realised at 114% in 2008 and at 98% for the last three years on average compared to the long-term target of 70%. The cash-con- version ability will ﬂ uctuate in any given year, and therefore the long-term target measures the cash to earnings ratio over a three-year period. Business results Performance in 2008 Operating margin Growth in operating proﬁt Return on invested capital (ROIC) Cash to earnings (three-year average) % % % 30 25 20 15 10 5 0 40 30 20 10 0 -10 50 40 30 20 10 0 % 100 80 60 40 20 0 2004 2005 2006 2007 2008 (cid:116) Target (cid:116) Realised (cid:116) Realised excl pulmonary (cid:116) diabetes projects 2004 2005 2006 2007 2008 (cid:116) Target (cid:116) Realised (cid:116) Realised excl pulmonary (cid:116) diabetes projects 2004 2005 2006 2007 2008 (cid:116) Target (cid:116) Realised 2004 2005 2006 2007 2008 (cid:116) Target (cid:116) Realised Long-term ﬁ nancial targets Focusing on growth, proﬁ tability, ﬁ nancial return and generation of cash, Novo Nor- disk introduced four long-term ﬁ nancial targets in 1996 to balance short- and long-term considerations, thereby ensuring a focus on shareholder value creation. The targets were subsequently revised and up- dated in 2001 and in 2006. By 2008, and despite a challenging currency exchange rate environment since the last update of the targets, Novo Nordisk has now reached the performance level stipulated in the four long-term ﬁ nancial targets and has consequently revised the target levels. The revision is based on an assumption of a continuation of the current business en- vironment and given the current scope of business activities and has been prepared assuming that currency exchange rates remain at current levels. The target level for operating proﬁ t growth remains at 15% on average. The target still allows for deviations in indivi- dual years if necessitated by business op- portunities, market conditions or exchange rate movements. The target level for operating margin is increased from 25% to 30%. The key en- abling factors are expected to be further productivity improvements in the manu- facturing and administrative areas while at the same time ensuring investments for both research and development as well as sales and marketing. It should be noted that the achievement of the operating margin target may be inﬂ uenced by signiﬁ - cant changes in market conditions includ- ing regulatory developments, changes in pricing environment, healthcare reforms as well as exchange rate movements. The target level for return on invested capital (ROIC) measured post tax is increased from 30% to 50%. The raised target reﬂ ects the expectation of contin- ued lower growth in invested capital rela- tive to operating proﬁ t as well as a stable effective tax rate. The target level for the cash-to-earnings ratio is increased from 70% to 80%, re- ﬂ ecting improved cash conversion ability. As previously, this target will be pursued looking at the average over a three-year period. Performance on this ratio may be impacted in individual years by signiﬁ cant acquisitions, investments or licensing activities. Ratio Previous target Result 2008 New targets Growth in operating proﬁ t Operating margin Return on invested capital (ROIC) Cash to earnings (three-year average) 15% 25% 30% 70% 38.4% 27.2% 37.4% 97.6% 15% 30% 50% 80% Novo Nordisk Annual Report 2008 9 Business results Performance in 2008 Diabetes care Novo Nordisk retained its position as global leader with 52% of the total insulin market and 44% of the modern insulin market, both measured by volume. The company is determined to sustain its leadership in diabetes care by leveraging the value of its full portfolio of modern insulins and delivery devices while devel- oping new antidiabetic agents and a new generation of insulins to better address future needs for effective diabetes care. See pp 30–37. Sales performance Sales of diabetes care products increased by 13% measured in local currencies and by 9% in Danish kroner to DKK 33,356 million compared to last year. Insulin value market share Geographical areas % 100 80 60 40 20 0 2007 2008 2005 2006 2004 (cid:116) Europe (cid:116) North America (cid:116) International Operations (cid:116) Japan & Oceania Modern insulins Global value market share of segment % 100 80 60 40 20 0 Modern insulins, human insulins and insulin-related products Sales of modern insulins, human insulins and insulin-related products increased by 12% measured in local currencies and by 9% in Danish kroner to DKK 30,965 million. All regions contributed to growth, with North America and International Op- erations having the highest growth rates. Sales of modern insulins increased by 28% in local currencies in 2008 and by 24% in Danish kroner to DKK 17,317 million. Sales of Levemir® increased by 55%, sales of NovoRapid® (NovoLog® in the US) increased by 22% and sales of NovoMix® (NovoLog® Mix 70/30 in the US) increased by 23%, all measured in local currencies. All regions realised solid growth rates, with North America and Europe as the primary contrib- utors to growth. Sales of modern insulins contributed 77% of the overall growth in local currencies and now constitute 59% of Novo Nordisk’s sales of insulins. North America Sales in North America increased by 21% in local currencies in 2008 and by 14% in Danish kroner, reﬂ ecting a solid penetration of the modern insulins Levemir®, NovoLog® and NovoLog® Mix 70/30. In the fourth quarter of 2008, US sales were positively impacted by a rebate reversal related to a federal healthcare programme. Novo Nordisk maintains its leadership posi- tion in the US insulin market with 41% of the total insulin market and 32% of the modern insulin market, both measured by volume. Currently, more than 37% of Novo Nordisk’s modern insulin volume is sold in FlexPen®. Europe Sales in Europe increased by 6% in local currencies and 5% measured in Danish kroner, reﬂ ecting continued progress for the portfolio of modern insulins. Novo Nordisk holds 55% of the total insulin market and 51% of the modern insulin market, both measured by volume, and is capturing the main share of growth in the modern insulin market. International Operations Sales within International Operations increased by 18% in local currencies and by 14% in Danish kroner. The main contributor to growth in 2008 was sales of modern insulins, primarily in Turkey and China. Furthermore, sales of human insulins continue to add to overall growth in the region, driven by China. 2005 2004 (cid:116) NovoRapid® (cid:116) NovoMix® (cid:116) Levemir® 2006 2007 2008 Japan & Oceania Sales in Japan & Oceania increased by 1% in local currencies and by 6% measured 10 Novo Nordisk Annual Report 2008 in Danish kroner. The sales development reﬂ ects sales growth for the modern insu- lins NovoRapid®, NovoRapid Mix® 30 and Levemir®. Novo Nordisk holds 72% of the total insulin market in Japan and 64% of the modern insulin market, both measured by volume. Oral antidiabetic products (NovoNorm®/Prandin®) Sales of oral antidiabetic products in- creased by 16% in local currencies and by 11% in Danish kroner to DKK 2,391 million compared to 2007. This primarily reﬂ ects increased sales in International Operations and North America, mainly due to an increased market share in China and a higher average sales price in the US market. Biopharmaceuticals Novo Nordisk continues to grow its bio- pharmaceuticals therapy areas by pursuing new indications for its existing product range and by exploring new potential proteins in other areas. See pp 38–41. Sales performance Sales of biopharmaceutical products increased by 11% measured in local cur- rencies and by 7% measured in Danish kroner to DKK 12,197 million compared to last year. NovoSeven® Sales of NovoSeven® increased by 14% in local currencies and by 9% in Danish kro- ner to DKK 6,396 million compared to last year. Sales growth for NovoSeven® was primarily realised in North America and International Operations. The sales growth for NovoSeven® during 2008 primarily reﬂ ected increased sales within the con- genital bleeding disorder segments, where Novo Nordisk is the global leader, and was supported by the launch of room temper- ature-stable NovoSeven® in the US as well as key markets in Europe. Treatment of spontaneous bleeds for congenital inhibi- tor patients remains the largest area of use. In the fourth quarter of 2008, sales of NovoSeven® in the US were positively im- pacted by wholesaler stock building. Sales of NovoSeven® in International Operations in 2008 were positively impacted by the timing of tender sales compared to 2007. Growth hormone therapy (Norditropin®) Sales of Norditropin® (ie growth hormone in a liquid, ready-to-use formulation) in- creased by 12% measured in local curren- cies and by 10% measured in Danish kro- ner to DKK 3,865 million. North America and Europe were the main contributors to growth measured in local currencies. Novo Nordisk is the second-largest company in this market with 23% market share meas- ured by volume. Other products Sales of other products within bio- pharmaceuticals, which predominantly consist of hormone replacement therapy (HRT)-related products, increased by 1% in local currencies and decreased by 2% in Danish kroner to DKK 1,936 million. This development primarily reﬂ ects generic competition in the US for Activella®, a con- tinuous-combined HRT product, but also continued sales progress for Vagifem®, Novo Nordisk’s topical oestrogen product. Pipeline progress Novo Nordisk made signiﬁ cant progress in research and development in 2008. See pp 18–19 for a status on the current pipe- line and progress during the year. Within diabetes care the key events for late-stage pipeline compounds during 2008 are summarised below: • Novo Nordisk ﬁ led for regulatory ap- proval of liraglutide for the treatment of type 2 diabetes in the US, Europe, Japan and many other countries. The applica- tions contain documentation from an ex- tensive clinical development programme designed to obtain the indication for use of liraglutide to treat type 2 diabetes as an adjunct to diet and exercise, both as monotherapy and in combination with commonly used antidiabetic medications. • Novo Nordisk initiated the phase 3 programme with liraglutide for the treatment of severe obesity. • Novo Nordisk ﬁ nalised two phase 2 clinical studies with NN1250, a long- acting new generation of insulin with a potential duration of action of more than 24 hours, and two phase 2 clinical studies with NN5401, a neutral, soluble dual-acting, new generation of insulin, also with a potential duration of action of more than 24 hours. • A phase 2 clinical study was initiated with the longer-acting human GLP-1 analogue, NN9535, designed for once- weekly treatment of type 2 diabetes. • Novo Nordisk discontinued all pulmonary diabetes activities, including AERx®, in 2008 and decided to focus on injection- based delivery and alternative non- invasive approaches to delivery of insulin, GLP-1 and other therapeutic proteins. Business results Performance in 2008 Within biopharmaceuticals the key events for late-stage pipeline compounds in 2008 were: • Novo Nordisk received marketing ap- proval for a temperature-stable version of NovoSeven® which is expected to deliver signiﬁ cant patient beneﬁ ts including immediate access to treatment as well as fast and convenient adminis- tration when a bleeding episode occurs. In 2008, costs amounting to DKK 171 mil- lion in connection with general employee share programmes were expensed. In 2008, Novo Nordisk expensed costs in relation to share-based long-term incen- tive programmes for senior management and other senior employees (around 580 participants in total) amounting to DKK 160 million. The comparable expense for 2007 was DKK 121 million (around 525 participants in total). • A phase 3 study with recombinant FXIII in congenital FXIII deﬁ ciency was initi- ated. Licence fees and other operating income were DKK 286 million in 2008 compared to DKK 321 million in 2007. • A phase 2 clinical study was initiated with a long-acting human growth hormone analogue designed for once- weekly treatment. • Novo Nordisk decided to discontinue the phase 3 clinical study with Novo- Seven® for the treatment of bleeding in patients with severe trauma. • An update of the haemostasis strat- egy was presented including plans for continuing development of potential successors to NovoSeven® as well as extending activities into general haemo- philia. • Novo Nordisk decided to discontinue the phase 3 study with Norditropin® in dialysis patients with low serum albumin. Operating performance The cost of goods sold was DKK 10,109 million in 2008, representing a gross margin of 77.8% compared to 76.6% in 2007. This improvement reﬂ ects improved produc- tion efﬁ ciency and higher average prices in the US. The gross margin was negatively impacted by around 0.5 percentage points due to a negative currency development. In 2008, total non-production-related costs amounted to DKK 23,357 million and were largely at the same level as in 2007. This development reﬂ ects lower costs related to research and develop- ment, primarily reﬂ ecting the non-recur- ring costs related to the discontinuation of AERx® in 2007, of DKK 1,325 million and non-recurring costs of DKK 325 million in 2008 related to the discontinuation of AERx® and other pulmonary diabe- tes projects. Sales and distribution costs increased at a lower level than sales, primarily explained by a return of a deposit related to an antidumping case in Brazil countered by higher costs related to the expanded sales force in the US. Operating proﬁ t in 2008 increased by 38% to DKK 12,373 million compared to 2007. Net ﬁ nancials and tax Net ﬁ nancials showed a net income of DKK 322 million in 2008 compared to a net income of DKK 2,029 million in 2007. Gross margin % 80 78 76 74 72 70 12 10 8 6 4 2 0 2005 2006 2007 2004 (cid:116) Development in gross margin 2008 Research & development costs DKK billion 2004 2005 2006 2007 2008 Diabetes care (cid:116) (excl pulmonary diabetes projects) (cid:116) Biopharmaceuticals Novo Nordisk Annual Report 2008 11 Business results Performance in 2008 Included in net ﬁ nancials is the result from associated companies with an expense of DKK 124 million, primarily related to Novo Nordisk’s share of losses in ZymoGenetics, Inc of approximately DKK 192 million. In 2007, the result from associated compa- nies was an income of DKK 1,233 million, primarily related to the non-recurring US dollar Cover and exchange rate Months Rate 12/07 03/08 06/08 09/08 12/08 (cid:116) Cover (left) (cid:116) Rate (right) Japanese yen Cover and exchange rate Months Rate 540 520 500 480 460 440 6.0 5.7 5.4 5.1 4.8 4.5 24 20 16 12 8 4 0 24 20 16 12 8 4 0 12/07 03/08 06/08 09/08 12/08 (cid:116) Cover (left) (cid:116) Rate (right) 12 Novo Nordisk Annual Report 2008 tax-exempt income of approximately DKK 1.5 billion from Novo Nordisk’s divest- ment of the ownership of Dako’s business activities. The foreign exchange result was an income of DKK 159 million compared to an income of DKK 910 million in 2007. This develop- ment reﬂ ects gains on foreign exchange hedging activities, especially in US dollars, partly offset by losses on commercial bal- ances in primarily non-hedged currencies. Foreign exchange hedging losses of DKK 864 million have been deferred for future income recognition, primarily in 2009. The effective tax rate for 2008 was 24.0%, an increase from 22.3% in 2007, when the effective tax rate was positively impacted by the non-recurring tax-exempt income from the divestment of Novo Nordisk’s ownership of Dako A/S’s business activities as well as from the non-recurring effect from the re-evaluation of the company’s deferred tax liabilities as a consequence of the reduction in the Danish corporation tax rate to 25%, introduced in 2007. Capital expenditure and free cash ﬂ ow Net capital expenditure for property, plant and equipment in 2008 was realised at DKK 1.8 billion compared to DKK 2.3 billion for 2007. The main investment projects in 2008 were manufacturing ex- pansion of FlexPen® assembly capacity as well as expansion of the puriﬁ cation and ﬁ lling capacity for insulin products. Free cash ﬂ ow for 2008 was realised at DKK 11.0 billion compared to DKK 9.0 bil- lion for 2007. Novo Nordisk’s ﬁ nancial re- sources at the end of 2008 were DKK 17.2 billion, higher than the level at the end of 2007. Included in the ﬁ nancial resources are unutilised committed credit facilities of approximately DKK 7.5 billion. Equity Total equity was DKK 32,979 million at the end of 2008, equal to 65.2% of total assets, compared to 67.4% at the end of 2007. Proposed dividend At the Annual General Meeting on 18 March 2009, the Board of Directors will propose a 33% increase in dividend to DKK 6.00 per share of DKK 1, correspond- ing to a payout ratio of 37.8%, compared to 34.9% for the ﬁ nancial year 2007, when adjusted for the impact from the divestment of Dako’s business activities and the AERx® discontinuation in 2007. No dividend will be paid on the company’s holding of treasury B shares. Share repurchase programme During 2008, Novo Nordisk repurchased 15,579,207 B shares at an average price of DKK 303 per share, equal to a cash value of DKK 4.7 billion. The Board of Directors has approved an increase of DKK 1.0 billion in the ongoing DKK 17.5 billion share repurchase programme, bringing the total share repurchase programme to DKK 18.5 billion. Novo Nordisk still expects to ﬁ nalise the share repurchase programme before the end of 2009. As a consequence Novo Nordisk expects to repurchase shares equal to a cash value of DKK 6 billion in 2009. In 2006 and 2007, Novo Nordisk repurchased B shares equal to a cash value of DKK 7.8 billion in total. Holding of treasury shares and reduction of share capital As per 28 January 2009, Novo Nordisk A/S and its wholly-owned afﬁ liates owned 25,721,095 of its own B shares, correspond- ing to 4.06% of the total share capital. In order to maintain capital structure ﬂ ex- ibility, the Board of Directors at the 2009 Annual General Meeting will also propose a reduction in the B share capital from DKK 526,512,800 to DKK 512,512,800 by cancelling 14,000,000 B shares of DKK 1 from the company’s own hold- ings of B shares at a nominal value of DKK 14,000,000, equal to 2.2% of the total share capital. After implementa- tion of the share capital reduction, the company’s share capital will amount to DKK 620,000,000 divided into an A share capital of DKK 107,487,200 and a B share capital of DKK 512,512,800. Business results Performance in 2008 Legal issues Novo Nordisk is party to a number of legal cases. See key legal issues and information on contingencies for pending litigations on pp 86–87. Long-term incentive programmes Novo Nordisk’s existing remuneration policy for executives aims to attract, retain and motivate members of the Board of Directors and Executive Management of Novo Nordisk. Remuneration levels are designed to be competitive and to align the interest of the executives with those of the shareholders. Long-term share-based incentive programme for senior management As from 2004, members of Novo Nor- disk's Executive Management (currently ﬁ ve) and the other members of the Senior Management Board (currently 24) have participated in a performance-based incentive programme where a proportion of the calculated shareholder value crea- tion has been allocated to a joint pool for the participants. For members of Execu- tive Management and the other members of the Senior Management Board the joint pool operates with a yearly maxi- mum allocation per participant equal to eight months’ ﬁ xed base salary plus pen- sion contribution. Once the joint pool has been approved by the Board of Directors the total cash amount is converted into Novo Nordisk A/S B shares at market price. The shares in the joint pool are locked up for a three-year period before they potentially may be transferred to the participants. For 2005, 232,026 shares were allocated to the joint pool and the market value of the scheme, corresponding to DKK 35.5 million, was expensed in 2005. The number of shares in the 2005 joint pool has not been reduced as the ﬁ nancial performance in the subsequent years (2006–2008) reached speciﬁ ed thresh- old levels. Hence, the original number of shares allocated to the joint pool will, according to the principles of the scheme, be transferred to 23 current and former members of senior management immediately after the announcement of the full-year 2008 ﬁ nancial results on 29 January 2009. For 2008 and based on an assessment of the economic value generated in 2008, as well as the performance of the R&D portfolio and key sustainability projects, the Board of Directors on 28 January 2009 approved the establishment of a joint pool for the ﬁ nancial year 2008 by allocating a total of 171,492 Novo Nordisk B shares, corresponding to a cash value of DKK 55 million. This allocation amounts to eight months of ﬁ xed base salary and pension on average per participant. This amount was expensed in 2008. As the long-term share-based incentive programme is evaluated by the Board of Directors to have worked successfully in 2008, it is planned to continue in 2009 with an unchanged structure. Long-term share-based incentive programme for corporate vice presidents and vice presidents As from 2007, a number of key employ- ees below top-level management also participate in a share-based programme with similar performance criteria as the programme for the members of Execu- tive Management and the other members of the Senior Management Board. The share-based incentive programme for key employees will, as is the case for the pro- gramme for Executive Management and the other members of the Senior Man- agement Board, be based on an annual calculation of shareholder value creation compared to the planned performance for the year. The pool will operate with a max- imum contribution per participant equal to four months’ ﬁ xed base salary. The shares in the pool are also locked up for a three- year period before they potentially may be transferred to the participants. Based on an assessment of the economic value generated in 2008 as well as the performance of the R&D portfolio and key sustainability projects, the Board of Directors on 28 January 2009 approved the establishment of a pool for 2008 by allocating a total of 570,390 Novo Nordisk B shares, corresponding to a cash value of DKK 181 million. This allocation amounts to four months of ﬁ xed base salary on average per participant. The number of participants for 2008 is approximately 550. The cash value of the allocation will be amortised over four years. Compliance with Sarbanes–Oxley requirements In 2008, Novo Nordisk was, as was the case in 2007, compliant with the US Sarbanes–Oxley Act section 404 that requires detailed documentation of how ﬁ nancial reporting processes, systems and controls are designed and operating. Man- agement’s conclusion and the external auditor’s certiﬁ cation of the 2008 compli- ance are included in the Form 20-F, which Novo Nordisk as a listed company on the New York Stock Exchange is required to ﬁ le with the US Securites and Exchange Commission (SEC). Form 20-F is expected to be ﬁ led in February 2009. Non-ﬁ nancial performance Managing direct and indirect economic, environmental and social impacts in areas of strategic importance serves a dual purpose: to reduce risks and to strengthen competitiveness. Novo Nordisk’s Triple Bottom Line approach aims to deliver long-term value to the business and bene- ﬁ ts to society. See performance highlights on p 17 and the consolidated non-ﬁ nancial statements on pp 89–99. Economics In 2008, Novo Nordisk created 1,059 new positions worldwide and had 26,575 full-time positions, measured as full-time equivalents (FTE) at the end of the year. This is an increase of 4% compared to 2007 and reﬂ ects the company’s contin- ued expansion, particularly in sales and Novo Nordisk Annual Report 2008 13 Business results Performance in 2008 Full-time positions Geographical areas 1,000 full-time positions 30 25 20 15 10 5 0 130 120 110 100 90 2004 2005 2006 2007 2008 Denmark (cid:116) Europe (excluding Denmark) (cid:116) North America (cid:116) International Operations (cid:116) Japan & Oceania Sales per average full-time position Index (2003 = 100) 2005 2006 2004 (cid:116) Sales in DKK per average full-time position 2007 2008 Environmental impacts compared to sales Index (2003 = 100) 120 100 80 60 40 2006 2005 2004 (cid:116) CO2 emissions/sales in DKK (cid:116) Waste/sales in DKK 2007 2008 14 Novo Nordisk Annual Report 2008 marketing functions and geographically in International Operations. Via the mul- tiplier effect, the increase translates into 61,925 indirect jobs in the global supply chain. In 2008, a new diversity strategy was implemented, setting a ﬁ ve-year goal for all senior management teams to be diverse in terms of gender and national- ity. See p 27. Sales per employee was DKK 1.7 million, up from DKK 1.6 million in 2007, indicat- ing an ability to maintain high productivity while expanding the workforce. Environment Novo Nordisk strives to reduce resource consumption and waste production. The aim is to decouple production growth and environmental impacts. The level of employee engagement is measured by the average answers of 10 equally weighted questions in the annual survey, eVoice. In 2008, the consolidated score (on a scale of 1–5, with 5 being highest) was 4.2, increasing by 0.1 from 2007 and well above the long-term target of 4.0. This is underscored by a continued high closure rate at 99% of all action points arising from facilitations. The company’s ambitious long-term target to achieve a 10% absolute reduc- tion in CO2 emissions from production by 2014 as compared with 2004 levels is on track. In 2008, CO2 emissions fell for the ﬁ rst time from 236,000 tons in 2007 to 215,000 tons. It is expected that the curve will break signiﬁ cantly at the end of 2009 when supplies of wind energy for the Danish production facilities can begin. Measured by volume, the consumption of water and energy decreased by 17% and 9%, respectively, while waste volumes increased by 16%. The Eco Intensity Ratios (EIR) showed improved performance in both diabetes care and biopharmaceuti- cals, and for both water and energy, and on track with the targets for a 10% reduc- tion by 2010 compared with 2005. A set of new long-term targets for environmen- tal performance will be implemented as of 2009. See pp 28–29. A continued preventative focus on compli- ance with environmental regulation is beginning to show results. In 2008, the number of accidental releases decreased by 13% to a total of 91. However, in the same period, the number of breaches of regulatory limit values increased by 27% from 22 in 2007 to 28. During 2008, 13 prescreening audits and 19 regular audits of suppliers’ environmen- tal and social performance were conduct- ed. These resulted in four critical ﬁ ndings and termination of relationship with one supplier. Social Attraction and retention of talented people is a key precondition for Novo Nordisk’s ability to develop and grow its business. In 2008, employee turn- over increased to 12.1% from 11.6%. A global employer-branding campaign was launched in 2008. In 2008, the annual spending on training, measured as average spent per employee remained high, amounting to DKK 13,192, which was a slight increase of 0.5%. This level reﬂ ects the company’s strategic priority on talent and leadership develop- ment, and on lifelong learning offered to all employees. Changing Diabetes®, Novo Nordisk’s global campaign to improve preven- tion, detection and care, effectively put diabetes on the public and political agendas. In the second year of marking the UN-observed World Diabetes Day, 14 November, Novo Nordisk succeeded in engaging more than 300,000 people in events in 56 countries. The company’s global advocacy to raise awareness of and spur action on diabetes supports the implementation of the UN Resolution on diabetes, adopted in December 2006, in recognition of diabetes as a major global health challenge and in respect of the human right to proper care. See pp 34–37. Novo Nordisk’s strategy to improve access to diabetes care is a long-term leadership strategy to promote on-time insulin and provide sustainable diabetes care for all who need it. It focuses on giving people with diabetes priority, driving health outcomes and breaking the curve of the diabetes pandemic. See pp 30–33. In 2008, the company launched an ambi- tious ﬁ ve-year programme to supply free insulin and care for children with type 1 diabetes in the world’s poorest countries. The programme, ‘Changing the Future for Children with Diabetes’ aims to reach a total of 10,000 children by 2013. It will be carried out in partnership with the World Diabetes Foundation and local partners. Outlook for 2009 Expectations are as reported, if not otherwise stated Current expectations 29 January 2009 Sales growth • in local currencies At the level of 10% • as reported Around 5 percentage points higher Operating proﬁ t growth At the level of 10% • in local currencies • as reported Around 9 percentage points higher Net ﬁ nancial expense Around DKK 1.6 billion Effective tax rate Around 24% Capital expenditure Around DKK 3 billion Depreciation, amortisation and impairment losses Around DKK 2.6 billion Free cash ﬂ ow At least DKK 9 billion Novo Nordisk expects sales growth in 2009 at the level of 10% measured in local cur- rencies. This is based on expectations of continued market penetration for Novo Nor- disk’s key strategic products within diabetes care and biopharmaceuticals as well as expectations of continued intense competi- tion during 2009. Given the current level of exchange rates versus Danish kroner, the reported sales growth is expected to be Forward-looking statement Novo Nordisk’s reports ﬁ led with or furnished to the US Securities and Exchange Commission (SEC), including this document and the company’s Form 20-F (expected to be ﬁ led with the SEC in Febru- ary 2009), and written information released, or oral statements made, to the public, in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as ‘believe’, ‘expect’, ‘may’, ‘will’, ‘plan’, ’strategy’, ’prospect’, ’foresee’, ’estimate’, ’project’, ’anticipate’, ’can’, ’intend’, ‘target’ and other words and terms of similar meaning in con- nection with any discussion of future operating or ﬁ nancial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to: • statements of plans, objectives or goals for future operations, including those related to Novo Nordisk’s products, product research, product development, product introductions and product approvals as well as cooperations in relation thereto, • statements containing projections of or targets for revenues, income (or loss), earnings per around 5 percentage points higher than the growth rate measured in local currencies. For 2009, operating proﬁ t growth meas- ured in local currencies is expected to be at the level of 10%. The forecast reﬂ ects a continued improvement of the gross margin and increased spending for sales and distribution relative to sales due to an expected high level of sales and marketing activities primarily related to the expected approval and launch of liraglutide and continued global market penetration for the portfolio of modern insulins. Given the current level of currency exchange rates versus Danish kroner, the reported operat- ing proﬁ t growth is expected to be around 9 percentage points higher than the growth rate measured in local currencies. For 2009, Novo Nordisk expects a net ﬁ nancial expense of around DKK 1.6 billion, reﬂ ecting signiﬁ cant foreign exchange hedg- ing losses, primarily related to the US dollar and the Japanese yen as well as expected losses related to non-hedged currencies. The effective tax rate for 2009 is expected to be around 24%. Capital expenditure is expected to be around DKK 3 billion in 2009. Expectations for depreciations, amortisation and impairment losses are around DKK 2.6 billion, and free cash ﬂ ow is expected to be at least DKK 9 billion. share, capital expenditures, dividends, capital structure or other ﬁ nancial ratios, • statements of future economic performance, future actions and outcome of contingencies such as legal proceedings, and • statements of the assumptions underlying or relating to such statements. In this document, examples of forward-looking statements can be found under the headings ‘Our focus is our strength’, ‘Pursuing a focused strat- egy’, ‘Performance in 2008’, including long-term ﬁ nancial targets, ‘Outlook for 2009’ and note 31, ‘Financial risk’, on p 76. These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and speciﬁ c. Novo Nordisk cautions that a number of important fac- tors, including those described in this document, could cause actual results to differ materially from those contemplated in any forward-looking state- ments. Business results Outlook for 2009 All of the above expectations are based on the assumption that the global economic downturn will not signiﬁ cantly deteriorate the business environment for Novo Nordisk during 2009. In addition, all of the above expectations are provided that currency exchange rates, especially the US dollar, re- main at the current level versus the Danish krone for the rest of 2009. Novo Nordisk has hedged expected net cash ﬂ ows in relation to US dollars, Japanese yen, Brit- ish pounds, Chinese yuan and Canadian dollars and, all other things being equal, movements in key invoicing currencies will impact Novo Nordisk’s operating proﬁ t as outlined in the table below. Invoicing currency Annual impact on Novo Nordisk’s operating proﬁ t of a 5% movement in currency Hedging period (months) USD JPY GBP CNY CAD DKK 530 million DKK 150 million DKK 80 million DKK 80 million DKK 40 million 15 14 13 15 *) 5 *) USD used as proxy for hedging of Novo Nordisk’s CNY exposure. The ﬁ nancial impact from foreign ex- change hedging is included in ‘Net ﬁ nancials’. or failure of projects related to research and/or development, unplanned loss of patents, inter- ruptions of supplies and production, product recall, unexpected contract breaches or termina- tions, government-mandated or market-driven price decreases for Novo Nordisk’s products, introduction of competing products, reliance on information technology, Novo Nordisk’s ability to successfully market current and new products, exposure to product liability and legal proceed- ings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protec- tion and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees and failure to maintain a culture of compliance. Please also refer to the overview of risk factors in ‘Managing risks’ on pp 24–25. Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate ﬂ uctuations, delay Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the dis- tribution of this document, whether as a result of new information, future events or otherwise. Novo Nordisk Annual Report 2008 15 Business results Financial highlights Sales 2004 2005 2006 2007 2008 2007–2008 2007 2008 DKK million DKK million DKK million DKK million DKK million Change EUR million EUR million Diabetes care: Modern insulins (insulin analogues) Human insulins Insulin-related sales Oral antidiabetic products (OAD) 4,507 13,033 1,350 1,643 7,298 13,543 1,463 1,708 10,825 13,451 1,606 1,984 14,008 12,572 1,749 2,149 17,317 11,804 1,844 2,391 Diabetes care total 20,533 24,012 27,866 30,478 33,356 Biopharmaceuticals: Haemostasis management Growth hormone therapy Hormone replacement therapy Other products Biopharmaceuticals total 4,359 2,317 1,488 334 8,498 5,064 2,781 1,565 338 5,635 3,309 1,607 326 5,865 3,511 1,668 309 6,396 3,865 1,612 324 9,748 10,877 11,353 12,197 Total sales by segment 29,031 33,760 38,743 41,831 45,553 Europe *) North America International Operations *) Japan & Oceania 12,887 7,478 4,368 4,298 14,020 9,532 5,497 4,711 15,300 12,280 6,494 4,669 16,350 13,746 7,295 4,440 17,219 15,154 8,425 4,755 Total sales by geographical area 29,031 33,760 38,743 41,831 45,553 3,309 (768) 95 242 2,878 531 354 (56) 15 844 3,722 869 1,408 1,130 315 3,722 1,880 1,687 235 288 4,090 788 471 224 41 1,524 5,614 2,194 1,845 979 596 5,614 2,323 1,583 247 321 4,474 858 518 216 43 1,635 6,109 2,309 2,032 1,130 638 6,109 15% (4%) 11% 15% 1% 16% 16% (1%) 15% 13% (5%) 8% 12% (3%) 9% DKK million DKK million DKK million DKK million DKK million Change EUR million EUR million Price and volume/mix Currency Total growth Key ﬁ gures Operating proﬁ t Operating proﬁ t excl AERx® **) Net ﬁ nancials Proﬁ t before income taxes Net proﬁ t Equity Total assets Capital expenditure (net) Free cash ﬂ ow Per share/ADR of DKK 1 6,980 – 477 7,457 5,013 26,504 37,433 2,999 4,278 8,088 – 146 8,234 5,864 27,634 41,960 3,665 4,833 Earnings per share Earnings per share, diluted Proposed dividend Quoted price at year-end for B shares Ratios Growth in operating proﬁ t Growth in operating proﬁ t excl AERx® **) Growth in operating proﬁ t, three-year average Operating proﬁ t margin Operating proﬁ t margin excl AERx® **) Return on invested capital (ROIC) Cash to earnings Cash to earnings, three-year average Net proﬁ t margin Equity ratio DKK 7.45 7.42 2.40 150 % 8.7 – 8.9 24.0 – 21.5 85.3 59.0 17.3 70.8 DKK 8.95 8.92 3.00 178 % 15.9 – 11.0 24.0 – 24.7 82.4 82.4 17.4 65.9 9,119 – 45 9,164 6,452 30,122 44,692 2,787 4,707 DKK 10.05 10.00 3.50 236 % 12.7 – 12.4 23.5 – 25.8 73.0 80.2 16.7 67.4 8,942 10,267 2,029 10,971 8,522 32,182 47,731 2,268 9,012 DKK 13.49 13.39 4.50 335 % (1.9) 12.6 8.9 21.4 24.5 27.2 105.7 87.0 20.4 67.4 12,373 12,698 322 12,695 9,645 32,979 50,603 1,754 11,015 3,431 2,431 (1,707) 1,724 1,123 797 2,872 (514) 2,003 DKK Change 15.66 15.54 6.00 271 2.17 2.15 1.50 (64) 1,200 1,378 272 1,472 1,144 4,316 6,401 304 1,210 EUR 1.81 1.80 0.60 44.96 1,660 1,704 43 1,703 1,294 4,426 6,792 235 1,478 EUR 2.10 2.08 0.81 36.35 % Long-term ﬁ nancial target in % ***) 15% 25% 30% 70% 38.4 23.7 16.4 27.2 27.9 37.4 114.2 97.6 21.2 65.2 ***) Comparative sales ﬁ gures from 2004 to 2006 have been adjusted in order to reﬂ ect a changed organisational structure from 1 January 2007 which transferred eight countries, incl Bulgaria and Romania, from International Operations to Europe. ***) Excluding costs related to the discontinuation of pulmonary projects. ***) The long-term ﬁ nancial targets were updated in January 2009. See p 9. Key ﬁ gures are translated into EUR as supplementary information – the translation of income statement items is based on the average exchange rate in 2008 (EUR 1 = DKK 7.45593) and the translation of balance sheet items is based on the exchange rate at the end of 2008 (EUR 1 = DKK 7.45060). 16 Novo Nordisk Annual Report 2008 Business results Non-ﬁ nancial highlights Economics R&D R&D expenditure to tangible investments *) R&D as share of sales *) Remuneration Remuneration as share of cash received Ratio % % 2004 2005 2006 2007 1.5:1 15.0 34 1.4:1 15.1 34 2.3:1 16.3 33 3.2:1 17.2 32 2008 4.3:1 16.5 31 Employment Employment impact worldwide (direct and indirect) Number of jobs 73,100 78,000 82,700 81,600 88,500 Corporate tax Total corporate tax as share of sales % Exports Novo Nordisk exports as share of Danish exports (estimated) % 8.4 3.9 7.0 4.7 7.0 4.0 5.9 3.4 6.7 2.7 Environment Resources Water consumption Energy consumption Raw materials and packaging materials Wastewater COD Nitrogen Phosphorus Waste Total waste Recycling percentage Emissions to air CO2 CO2 emissions/sales in DKK (Index 2003 = 100) Organic solvents EIR Water EIR Energy Diabetes care Biopharmaceuticals Diabetes care Biopharmaceuticals Compliance Breaches of regulatory limit values Accidental releases 1,000 m3 1,000 GJ 1,000 tons Tons Tons Tons Tons % 1,000 tons Tons/Sales in DKK Tons m3/MU m3/g API GJ/MU GJ/g API Number Number Social Living our values Importance of social and environmental issues for the future People of the company **) Scale 1–5 Managers’ behaviour consistent with Novo Nordisk’s values **) Scale 1–5 Fulﬁ lment of action points from facilitations of the NNWoM % Number Employees (total) % Rate of absence % Rate of employee turnover Engaging culture (employee engagement) **) Scale 1–5 Opportunity to use and develop competences/skills **) Scale 1–5 People from diverse backgrounds have equal opportunities **) Scale 1–5 2,756 2,397 111 1,448 121 21 3,014 2,679 135 1,303 126 22 2,995 2,712 142 1,000 107 19 3,231 2,784 152 813 107 14 2,684 2,533 132 891 95 15 21,855 40 23,776 33 24,165 35 17,576 38 20,346 51 210 92 115 – – – – 74 29 4.2 4.0 96 20,725 3.2 7.3 – 3.8 3.8 228 86 124 – – – – 174 104 229 75 102 7.8 4.8 5.5 9.2 123 135 236 72 81 7.3 4.1 5.1 7.9 22 105 215 60 93 5.5 3.7 4.0 7.3 28 91 4.2 4.0 100 22,460 3.2 8.0 – 3.8 3.9 7.3 0 4.3 4.1 99 23,613 3.0 10.0 4.0 3.9 3.9 6.2 0 4.4 4.2 99 26,008 2.7 11.6 4.1 4.0 4.0 5.9 0 4.5 4.3 99 27,068 2.2 12.1 4.2 4.1 4.1 5.4 0 Health & safety Frequency of occupational injuries Fatalities Training costs Annual training costs per employee Access to health LDCs where Novo Nordisk operates LDCs where Novo Nordisk sells insulin at or below the policy price Healthcare professionals trained or educated People with diabetes trained or treated Patent families Active patent families to date New patent families (ﬁ rst ﬁ ling) Animals Animals purchased **) R&D costs adjusted for costs related to discontinuation of all pulmonary diabetes projects. **) On a scale of 1–5, with 5 being the highest. See the consolidated non-ﬁ nancial statements on pp 89–99. No/million work hrs Number 5.6 1 DKK Number Number 1,000 1,000 Number Number Number 8,992 9,899 11,293 13,130 13,192 35 33 – – 778 145 35 32 – – 812 130 35 38 36 34 297 1,060 913 149 36 336 1,260 1,003 116 32 380 1,854 890 71 47,311 57,905 56,533 54,675 57,253 Novo Nordisk Annual Report 2008 17 Business results Pipeline progress Pipeline progress In 2008, signiﬁ cant progress was made across Novo Nordisk’s clinical development pipeline. This overview illustrates key development activities: entries into the pipeline, progression of development compounds, exits from the pipeline and major regulatory approvals. Diabetes care Biopharmaceuticals See more at novonordisk.com/investors/rd_pipeline/rd_pipeline.asp. Phase 1 Studies in a small group of healthy volunteers, and sometimes patients, usually between 10 and 100, to investigate how the body handles new medication and establish maximum tolerated dose. Phase 2 Testing a drug at various dose levels in a larger group of patients to learn about its effect on the condition and its side effects. rFVIIa subcutaneous formulation (NN7720) (Haemophilia patients with inhibitors) NN1250 (Type 1 and type 2 diabetes) Novo Nordisk is conducting a phase 1 study investigating bioavailability of subcutaneous injections of innovative formulation technologies to increase convenience of administration for patients. The trial is expected to be completed in 2009. Long-acting factor VIIa derivative (NN7128) (Haemophilia patients with inhibitors) In 2008, Novo Nordisk completed a phase 1 study of its long- acting recombinant factor VIIa analogue involving 40 healthy males. The analogue is a potential next-generation derivative of NovoSeven® in the treatment of haemophilia patients with inhibitors. With its long duration of action, it is intended to enable prevention of bleeding for the patient. Novo Nordisk expects to initiate a phase 2 clinical trial in 2009. rFXIII (NN1810) (Cardiac surgery) In 2008, Novo Nordisk completed a phase 1 study of recombinant blood-clotting factor FXIII in patients undergoing cardiac surgery involving 43 patients and expects to initiate a phase 2 trial in 2009. In 2008, Novo Nordisk completed a phase 2 programme for NN1250, a neutral, soluble, long-acting new generation of insulin with a ﬂ at and predictable proﬁ le, potentially providing more than 24-hour coverage by once-daily injection. Novo Nordisk expects to initiate phase 3 trials in the second half of 2009. NN5401 (Type 1 and type 2 diabetes) In 2008, Novo Nordisk completed a phase 2 programme for NN5401, a neutral, soluble, dual-acting new generation of insulin with improved properties and potential duration of action above 24 hours. Novo Nordisk expects to initiate phase 3 trials in the second half of 2009. Once-weekly GLP-1 analogue (NN9535) (Type 2 diabetes) Novo Nordisk is conducting a phase 2 clinical trial of a once- weekly GLP-1 human analogue, designed for people with type 2 diabetes. The phase 2 clinical trial involves more than 400 patients and is expected to be completed in the ﬁ rst half of 2009. Anti-IL20 (Psoriatic arthritis and rheumatoid arthritis) rFVIIa analogue (NN1731) (Haemophilia patients with inhibitors) In 2008, Novo Nordisk initiated a phase 1 clinical study of anti-IL20, a monoclonal antibody neutralising the interleukin 20 protein. The clinical trial programme involves a study of about 80 patients with moderate-to-severe plaque psoriasis as well as a smaller combined phase 1 trial in healthy volunteers and patients with rheumatoid arthritis. Novo Nordisk is conducting a phase 2 trial of its fast- acting recombinant analogue of rFVIIa involving about 75 haemophilia patients with inhibitors. The targeted and topicalised mode of action is expected to deliver predictable, fast and sustainable haemostasis. The trial is expected to be completed in 2009. Anti-C5aR (Rheumatoid arthritis and systemic lupus erythematosus) Once-weekly growth hormone (Growth hormone deﬁ ciency) A phase 1 clinical study was initiated in 2008 for anti-C5aR, a monoclonal antibody blocking the C5a receptor. The study involved around 50 healthy volunteers. If successful, this will be followed by trials in patients with rheumatoid arthritis and systemic lupus erythematosus. In 2008, Novo Nordisk moved its long-acting growth hor- mone compound into a phase 2 trial involving more than 30 adults. The product is intended to improve patient conveni- ence by reducing the number of injections needed. The trial is expected to be completed in 2009. 18 Novo Nordisk Annual Report 2008 Business results Pipeline progress “Novo Nordisk will sustain its leadership in diabetes care by providing new treatments to achieve safe glycaemic control and weight beneﬁ ts.” Mads Krogsgaard Thomsen Chief science ofﬁ cer Phase 3 Studies in large groups of patients worldwide, comparing the new medication with a commonly used drug or placebo for both safety and efﬁ cacy in order to establish its beneﬁ t-risk relationship. Filed/regulatory approval A New Drug Application is submitted for review by various government regulatory agencies. Liraglutide (Obesity) Liraglutide (Type 2 diabetes) In 2008, Novo Nordisk moved its study for the use of liraglutide as an antiobesity treatment into phase 3. The phase 3 programme will include around 5,000 people and will focus on weight loss and delayed onset of type 2 diabetes, weight loss in subjects with type 2 diabetes and prevention of weight regain. Novo Nordisk expects to complete the programme in 2011. rFXIII (NN1841) (Congenital rFXIII deﬁ ciency) Novo Nordisk is developing a recombinant FXIII intended to treat congenital FXIII deﬁ ciency. FXIII is part of the coagulation cascade and functions by cross-linking ﬁ brin to increase the stability of the clot, making it mechanically stronger and more rigid and elastic. The phase 3 trial involves 40 patients and is expected to be completed in 2009. In 2008, Novo Nordisk applied for regulatory approval for liraglutide in the US, Europe and Japan among many other countries. Liraglutide is a long-acting human GLP-1 analogue. The clinical development programme involved around 6,200 patients. It is targeted as a treatment for type 2 diabetes as an adjunct to diet and exercise, both as monotherapy and in combination with commonly used antidiabetic medications. NovoMix® 50 and 70 (Type 1 and type 2 diabetes) NovoMix® 50 and 70 are premixed formulations of the rapid-acting modern insulin aspart. The phase 3 programme involved around 1,500 patients with type 1 or type 2 diabetes. NovoMix® 50 and 70 have been launched in Europe and NovoMix® 50 is approved in the US. Phase 3 trials are under way in Japan. PrandiMet® (Type 2 diabetes) A tablet formulation combining the short-acting insulin secretagogue repaglinide with the insulin-sensitising agent metformin in a single tablet. The clinical development programme for this combination regimen has involved more than 550 patients. PrandiMet® has been approved and launched in the US. Activelle®/Eviana® low dose (Hormone replacement therapy) The low-dose version of Activelle® (Activella® 0.5 mg/0.1 mg in the US) is a continuous-combined hormone replacement therapy intended for treatment of menopausal symptoms and as one of the treatment alternatives for osteoporosis prevention. In 2008, it was launched in the US and approved by EU regulatory authorities. Vagifem® low dose (Hormone replacement therapy) Vagifem® low dose is a topical product for vaginal appli cation. It was ﬁ led for approval in the EU in November 2008. Novo Nordisk Annual Report 2008 19 Business environment Doing business the Novo Nordisk Way Doing business the Novo Nordisk Way The Novo Nordisk Way of Manage- ment forms the values-based govern- ance framework for the company. From vision to policies, it guides how people at Novo Nordisk put values into action and deﬁ nes the principles for how the company does business. The Novo Nordisk Way of Management de- scribes the principles for how to work and behave as an employee of Novo Nordisk. It consists of three elements: the vision, the charter and a set of global policies. This comprehensive framework was de- veloped more than a decade ago to help grow a culture of empowerment and in- novation, and it has proven to be a robust system. Pursuing the vision Novo Nordisk’s aspiration is to be the world’s leading diabetes care company and, ultimately, to defeat diabetes. This is the core business proposition, the essence of Novo Nordisk’s contribution to sustain- able development and the heart of the vision. The vision sets Novo Nordisk’s objectives in context and inspires people in their work. It serves to keep everyone’s focus on creating long-term shareholder value and leveraging the company’s unique qualities to gain competitive advantage. ity, expressed by the Triple Bottom Line, fundamental principles of management, as well as a follow-up methodology to ensure adherence to the principles across the organisation. As part of the follow-up methodology Novo Nordisk has a global facilitator team consisting of senior people with deep insight into the business and the busi- ness environment. On a three-year basis, or more frequently, they measure the extent to which business units operate in compliance with the Novo Nordisk Way of Management. Values in action The charter includes the values, the commitment to corporate responsibil- The head of the facilitation group has a formal reporting line to the chairman of the Board. The Novo Nordisk Way of Management Vision Charter Values Commitments Fundamentals Follow-up methodology Policies 20 Novo Nordisk Annual Report 2008 Vision The vision describes what the company aims to achieve, and how: • We will be the world’s leading diabetes care company • We will offer products and services in other areas where we can make a difference • We will achieve competitive business results • A job here is never just a job • Our values are expressed in all our actions Charter Values Each employee is expected to be: accountable, ambitious, responsible, engaged with stakeholders, open and honest, and ready for change. Commitments Novo Nordisk is committed to conducting its activities in a ﬁ nancially, environmentally and socially responsible way. This commitment is anchored in the company’s Articles of Association. Any decision should always seek to balance three considerations. Is it economically viable? Is it socially responsible? Is it environmentally sound? Fundamentals A set of 11 management guidelines to ensure focus on efﬁ ciency and alignment in business direction, customer focus, organisational development, cross-functional cooperation and product quality. Follow-up methodology Ongoing systematic and validated documentation of performance in all material areas of Novo Nordisk. Four components provide assurance to stakeholders of the quality of the company’s processes and performance: ﬁ nancial and non-ﬁ nancial performance; facilitations; organisational audit including an assessment of ‘linking business and organisation’ as well as succession management; and quality audits. Policies In 13 selected areas greater mutual understanding and global standards are particularly helpful in guiding company operations: bioethics, business ethics, communication, environment, ﬁ nance, global health, health and safety, information technology, legal, people, purchasing, quality and risk management. Business environment Values drive performance Values drive performance In today’s interconnected economy the ability to manage the complexity of business and societal challenges helps ensure sustained growth. The Triple Bottom Line principle enables Novo Nordisk to balance corporate proﬁ t- ability with corporate responsibility, stay attuned to stakeholder concerns and exploit opportunities for innova- tive collaboration. From one perspective, the ﬁ nancial down- turn is likely to slow economic wealth creation and hamper equitable social development. From another, the current challenges may offer opportunities for alternative solutions that generate long- term value. Energy efﬁ ciency supports operational excellence and helps mitigate climate change, healthier lifestyles reduce costs for public healthcare systems and enhance people’s quality of life, and cost- consciousness sharpens focus on value- adding activities. The implications of the current global economic situation are yet to be seen, but history presents ample evi- dence that businesses that operate with a long-term view and a broad approach are more likely to be risk resilient and adapt- able to change. Earning trust Novo Nordisk’s values-based approach to doing business drives performance and enhances shareholder value. The Triple Bottom Line principle expresses Novo Nordisk’s commitment to sustainable deve lopment and balanced growth and is The Triple Bottom Line approach Economically viable Patients Novo Nordisk employee Jeppe Kjems took personal leave to travel across South America to help raise awareness and screen people for diabetes. consistent with the principles of the United Nations Global Compact. Through this approach, the company seeks to build its business in a way that is ﬁ nancially, environ- mentally and socially responsible. Decision- making seeks to balance short-term gains with long-term proﬁ tability and shareholder return with other stakeholder interests. In the current business environment there is more focus than ever on accountability and transparency. Renewed attention is given to risk management, and for the pharmaceut- ical industry reputational risk is of particular importance. Regulatory authorities, policy- makers, payers, patients and other stake- holder groups seek assurance that compa- nies act with integrity and can demonstrate consistency of words and deeds. licence to operate and innovate. It helps build reputation and earn trust among stakeholders, attract talent and engage people, build customer loyalty and drive innovation. Ultimately, the commitment to pursue ambitious long-term targets for socially, environmentally and ethically responsible conduct strengthens the com- pany’s competitive position in its markets. This is why Novo Nordisk has chosen to account for the company’s ﬁ nancial and non-ﬁ nancial performance in one, inclusive report. The intent is to enhance shareholders’ valuation of the company and demonstrate accountability to other stakeholders. See how Novo Nordisk deﬁ nes materiality of sustainability-driven issues on p 89 and performance data for prioritised actions on pp 90–99. Novo Nordisk Annual Report 2008 21 Socially responsible Environmentally sound The Triple Bottom Line plays a key role in earning and maintaining Novo Nordisk’s Business environment Pursuing a focused strategy drugs are often better suited to mid-size and smaller companies, which haven’t built, and don’t have to maintain, regula- tory and commercial infrastructures whose economic rationale depends on mass- market products. Which leaves the drug industry in a par- ticularly difﬁ cult position: infrastructure- and expense-heavy propped up for now by the signiﬁ cant cash ﬂ ow from its exist- ing products, but with precious little in its pipelines to replace essential blockbusters soon to face generic competition. Most Big Pharmas face the challenge of replac- ing products that will be generic within a few years and that today accounts for 25% or more of their 2007 cash ﬂ ow. In reaction, many drug ﬁ rms are diversify- ing into generics and OTC medicines, to tap into new markets and a more stable cash ﬂ ow. All of them are acquiring and/ or allying with biotechs to access large- molecule technologies and products. And all of them are at least attempting to restructure their commercial organisations to permit the kind of specialised market- ing that is second nature to mid-size and smaller companies. Maybe some of their experiments will work. But for large companies to thrive in this new environment, they will have to do more than experiment. They will have to embrace wholly new strategies which in turn will require painful managerial and infrastructure decisions. The shape of the industry – and the winners within it – will be determined by how the large drug companies adapt to the new realities. Roger Longman co-founded Windhover Information, publisher of pharmaceutical industry publications IN VIVO and START- UP, and the comprehensive database of industry alliances, Strategic Transactions. In March 2008, Windhover was acquired by Reed Elsevier and Longman is now managing director of Elsevier Business Intelligence. He has been involved with the healthcare industry for more than 20 years, is regularly asked to speak at many key industry events and lectures at leading universities. Pursuing a focused strategy Novo Nordisk is a focused healthcare company clearly differentiated from most other major global pharmaceu- tical companies. It has more than 85 years of specialisation in therapeutic proteins (biologicals) with a clear focus on targeted therapy areas and a strong research and development pipeline. Focus on proteins One of the key differentiators for Novo Nordisk compared with traditional big pharmaceutical companies is that Novo Nordisk’s business is almost purely focused on protein engineering, expression and formulation supported by device technol- ogy for the convenient administration of medicines. Conversely, most major pharmaceutical companies are cur- rently dependent on small-molecule drugs (medicines in tablet form) and trying to build a presence within proteins. However, developing protein-based drugs requires a very different set-up compared with small- molecule drugs. Novo Nordisk has world-leading compe- tences in engineering human proteins to make efﬁ cacious, convenient and safe treatment options for serious diseases such as diabetes, haemophilia and growth hormone disorders. Expression of proteins is a key area for Novo Nordisk. In fact, Novo Nordisk is at the forefront of innovation in protein expression in yeast, which is used for insu- lins, E coli, used for growth hormone, as well as mammalian cells, which are used for NovoSeven®. Global reach Even though Novo Nordisk focuses on relatively few therapy areas, the company sells its products in 179 countries and has a presence in 81 countries. Global sales force reach has been achieved by the company’s leadership position in diabetes care and is supported by expanded market positions within haemophilia and growth hormone disorders. Roger Longman Editor in Chief, IN VIVO Novo Nordisk invited Roger Longman to comment on the main challenges facing the pharmaceutical industry today. Industry trends It’s been a tough decade for the world’s largest drug companies. Big Pharma remains disturbingly reliant on developing new primary-care drugs that may improve upon existing therapies with- out signiﬁ cantly changing them. World regulatory bodies increasingly demand levels of safety assurance in chronic medi- cines that most companies simply can’t provide. And when they can, governments and insurers in the world’s largest markets increasingly balk at paying for the drugs. Science – at least the way Big Pharma has gone about taking advantage of it – hasn’t done much to help. The extraordinary pre- dictions that prompted and were in turn prompted by, the ﬂ ood of funding into genomics and other new drug discovery technologies in the late 1990s and early 2000s, have proven hollow. Plenty of new drugs may still come out of all this science, but they won’t come quickly. And they may not come from, or to, Big Pharma. The new drugs that are being approved often target conditions affecting relatively small patient populations, some- times because regulatory bodies impose strict marketing conditions. Those aren’t the kinds of markets in which Big Pharma is used to making money. Moreover, more of these new products are biologicals – fruits of a technology Big Pharma is still struggling to master. Indeed, today’s new 22 Novo Nordisk Annual Report 2008 Business environment Pursuing a focused strategy Historically, Novo Nordisk’s sales and marketing efforts have been focused on specialist doctors in all its therapy areas. Due to the rapid increase in diabetes prevalence, Novo Nordisk is expanding its reach to general practitioners to ensure people with diabetes receive timely treat- ment. This reduces the risk of long-term complications such as blindness and kidney failure. Focus on key therapy areas Diabetes care: strategy to expand leadership Novo Nordisk is the world’s leading insulin company with more than 50% market share by volume. Novo Nordisk is the only company with a full portfolio of modern insulins and the company produces the most widely used disposable and durable insulin pen devices in the world. Beginning with the ﬁ rst patients treated with insulin in the 1920s, Novo Nordisk has been dedicated to continuously improving the safety, effectiveness and convenience of diabetes treatment. Novo Nordisk’s leadership position within diabetes care is further underlined by the fact that it is the only company with two new generation insulins in late-stage clinical development. If successful, this new generation of insulins is expected to improve treatment outcomes and con- venience for people with diabetes even further. Both compounds are expected to enter into the ﬁ nal phase of clinical devel- opment before the end of 2009. The company’s long-acting GLP-1 ana- logue, liraglutide, has been submitted for regulatory review in the US, Europe and Japan, as well as other markets. Backed by robust clinical data, liraglutide is believed to be well positioned to gain leadership in this new segment in the diabetes care market. In early 2008, Novo Nordisk decided to stop all further development of inhaled insulin and to accelerate efforts in a new long-term ambition within diabetes care to develop GLP-1 products and oral insulin. The development of these new products is still at an early stage and many tech- nological barriers remain, but signiﬁ cant progress has been made and Novo Nordisk and its partners are enthusiastic about the potential within this area. Obesity and prediabetes: strategy to explore opportunity Novo Nordisk is looking at new ways to prevent type 2 diabetes by treating its pre- stages, including obesity, which is known to be a major risk factor in developing type 2 diabetes, cardiovascular disease as well as a range of other life-threatening diseases. More than 75% of people with diabetes are overweight or obese, as are the major- ity of prediabetic patients. The company initiated a phase 3 clinical trial for liraglutide treatment of obesity at the end of 2008. From a commercial perspective there is at- tractive potential, but also many challenges, for Novo Nordisk to move into prediabetes and obesity treatment. Biopharmaceuticals: strategy to establish leadership Novo Nordisk has a solid position in hae- mophilia with inhibitors due to the success of NovoSeven®, which remains the only recombinant treatment option for hae- mophilia patients with inhibitors. In 2008, Novo Nordisk launched a room tempera- ture-stable version of NovoSeven®. Novo Nordisk is also working to develop two po- tential successors to NovoSeven®: a long- acting recombinant factor VIIa derivative and a short-acting recombinant factor VIIa analogue, both in clinical development. To expand its leadership beyond haemo- philia with inhibitors, Novo Nordisk is committed to leveraging its core protein capabilities to develop recombinant factor VIII and IX compounds for the treatment of haemophilia A and B, respectively. The long-term ambition is to develop more convenient treatment options for haemo- philia patients. Novo Nordisk expects to move several new compounds into clinical development over the next couple of years. Within growth hormone therapy, Novo Nordisk continues to expand the label for Norditropin®, which is still the only liquid, room temperature-stable growth hormone product in a preﬁ lled pen device on the market. Novo Nordisk is developing a new-generation growth hormone that may signiﬁ cantly improve convenience for patients with growth hormone disorders. The new-generation growth hormone is designed to be injected once a week, compared with the existing growth hormone products that are once daily. Inﬂ ammation: strategy to build presence Inﬂ ammation is a relatively new area of investment for Novo Nordisk but, follow- ing the discontinuation of all research and development activities within oncol- ogy, Novo Nordisk has strengthened its efforts to establish a presence within this area. Building a presence within inﬂ am- mation is a long-term commitment and the company is in the process of estab- lishing a research centre in Seattle as well as investing in research and development in Denmark. In order to succeed, Novo Nordisk expects to rely on both internal research and external partnerships. The way forward The pharmaceutical industry and Novo Nordisk face a multitude of challenges (see pp 24–25). Compared with most ma- jor pharmaceutical companies, however, Novo Nordisk is relatively well positioned for future growth owing to its focus on proteins, attractive therapy areas and exciting opportunities in the development pipeline. To secure long-term success, Novo Nordisk will continue to grow its business in ways that are both responsible and sustainable. The company seeks to make a positive economic, environmental and social impact through its operations, global management standards, community en- gagements, partnerships and knowledge exchanges. Novo Nordisk Annual Report 2008 23 Business environment Managing risks Managing risks Increased pressure for substantial in- novation in research and development and the need to sustain the growth of Novo Nordisk’s business require an entrepreneurial spirit that encourages calculated risk-taking while upholding rigorous quality standards. At the same time, to protect its people, assets and reputation, Novo Nordisk has to be vigilant about assessing and effectively managing ﬁ nancial and non-ﬁ nancial risks. In the volatile economic climate of 2008, the importance of Novo Nordisk’s approach became clearer than ever. Overseen by its Risk Management Board, representing senior managers from all parts of the company’s value chain, Novo Nordisk has a systematic, integrated pro- cess to continually risk assess a wide range of potential issues. Enterprise risk manage- ment increases the company’s ability to assess and understand risks separately and in relation to each other. along with plans or processes to manage these risks. The Risk Ofﬁ ce challenges business areas about reported risks and encourages exploration of longer-term concerns. Reported risks are then con- solidated into a ranking and assessment of the company’s key risks. This informa- tion is presented to the Risk Management Board, who challenges the overall risk and control proﬁ le of Novo Nordisk. The process is linked to the strategic plan- ning process and considers both ﬁ nancial and non-ﬁ nancial risks. All assessments of risk take into account the likelihood of an event and its potential impact on the business. Impacts are quan- tiﬁ ed and assessed in terms of potential ﬁ nancial loss and reputational damage. Risks are assessed based both on the as- sumption that no mitigating actions will be implemented and at the net risk level, taking into account mitigating actions and their anticipated effect. Each quarter, all major business areas in the company are required to report to the Risk Ofﬁ ce their most signiﬁ cant risks, The risks that Novo Nordisk deems of greatest importance to its business are Risk management reporting structure External reporting Board of Directors Executive Management Risk Management Board Risk Ofﬁ ce Regions, committees, boards and management groups 24 Novo Nordisk Annual Report 2008 Risk assessment example t c a p m I Critical Major Moderate Minor Unlikely Possible Likely Very likely Likelihood • Gross assessment • Net assessment after mitigation categorised and described below. They are not, however, ranked. Many of these is- sues are discussed elsewhere in the report. Market risks Price pressures Novo Nordisk focuses on developing dif- ferentiated products that offer improved treatment options for patients and eco- nomic beneﬁ ts to healthcare systems. As healthcare costs have risen, outstripping the pace of economic growth, there is in- creasing economic, political and regulatory pressure to contain pharmaceutical prices. The current global economic contraction is likely to add to pressure on government budgets, exacerbating this trend, which could impact the company’s proﬁ tability. Documenting treatment beneﬁ ts is critical to ensuring that innovation is properly valued. Novo Nordisk is increasing the number of clinical and health economic studies to substantiate the beneﬁ ts of its products, particularly for improved diabe- tes treatment. Biosimilar competition The market for therapeutic proteins is becoming more attractive to biosimilar pro- ducers as more lenient regulatory rules in Europe have made it easier for producers to introduce biosimilar products when patent protection for branded products expires. More lenient rules have also been proposed in the US. The introduction of lower-priced, biosimilar products could potentially result in a signiﬁ cant reduction in net sales. Traditional insulins have been off patent for years so this is a risk with which Novo Nordisk is familiar and has considerable experience addressing. In countries such as India and China, where the company has long had biosimilar competition, Novo Nordisk has a volume market share of ap- proximately 60% in insulin. Infringement of intellectual property rights Patent rights promote and protect invest- ment in innovation, which leads to new and better treatments and long-term economic growth and job creation. Novo Nordisk defends its patent rights when- ever there is infringement that could have ﬁ nancial implications for the company. R&D risks Bringing new products to market Continued growth in Novo Nordisk’s business, particularly as patents expire, depends on the company’s ability to develop and market new treatments or breakthrough products. While Novo Nordisk commits substantial effort and resources to research and development activities, certain challenges could delay the introduction of new products. These include an increasingly difﬁ cult regulatory environment, recruitment of patients for clinical trials and issues related to produc- tion processes. Regulatory approval Before a new treatment can be launched, it must receive regulatory approval based on its safety and efﬁ cacy. The approval pro- cess for new products is generally lengthy and can be expensive and subject to delays. Failure to obtain, or delays in obtaining, regulatory clearance to market products could adversely affect the results of opera- tions. Even after a product is approved, it may be subject to regulatory action based on newly discovered ﬁ ndings about safety or efﬁ cacy. Regulatory action may ad- versely affect product marketing, require changes to product labelling or even lead to withdrawal of regulatory approval. Production and quality risks Supply disruptions Failure or breakdown in any of the com- pany’s vital production facilities could ad- versely affect the results of operations, as well as possibly causing employee injuries or infrastructure damage. Business environment Managing risks Fire-prevention design, alarms and ﬁ re instructions, annual inspections, back-up facilities and safety inventories are aimed at mitigating this risk. To spread this risk geographically and optimise costs and supply logistics, Novo Nordisk is expanding production capacity beyond the com- pany’s European base to the US, Brazil and China. Risk of product recalls Product safety is directly linked to patient well-being, so safety and product quality are paramount concerns from both ﬁ nan- cial and reputational perspectives. While the gross risk is very high, with product safety having the potential to adversely affect operations, Novo Nordisk believes that its vigorous efforts to manage and mitigate this risk effectively reduce the company’s net risk proﬁ le. Novo Nordisk has a corporate quality system in place, with quality audits, quality improve- ment plans and systematic management reviews. People-related risks Attracting and retaining talented people Particularly in areas where Novo Nordisk does not currently have a leadership posi- tion, recruiting can be a challenge. Novo Nordisk makes substantial investments in training, and this makes Novo Nordisk people attractive to other companies, particularly those seeking to build a strong platform within the diabetes segment. Appropriately managing remuneration, non-ﬁ nancial beneﬁ ts and recognition is critical to the company’s long-term success and is prioritised accordingly. Financial risks Exchange rates As a global business, ﬂ uctuations in cur- rency exchange rates impact the reported performance. Novo Nordisk’s reporting currency and the functional currency of corporate operations is the Danish krone, which is closely linked to the euro in a narrow range of ±2.25%. However, the company has substantial exposure to other currencies, including the US dollar, Japa- nese yen, Chinese yuan and British pound. For information on how the company manages these risks, see note 31 in the ﬁ nancial statements on p 76. The company’s ability to develop innova- tive products and ensure growth and high performance depends on its ability to attract and develop talented people. Ethical risks Marketing practices In a competitive environment with increas- ing public scrutiny and regulation, market- ing practices can be the source of legal action or reputational risk. The company’s reputation as a trusted healthcare partner is integral to its ability to effectively main- tain and grow its business. At the same time, the regulatory context for marketing activity is constantly changing. A business ethics policy and global busi- ness ethics procedures, paired with close monitoring of performance and enhanced reporting requirements, all aim to miti- gate these risks. The policy supplements long-standing local ethics and compliance policies. Signiﬁ cant resources are also dedicated to training marketing and sales people around the world. Legal risks Legal issues related to intellectual prop- erty, product liability claims and business practices are included in the overview of current legal cases on pp 86–87. Mao Jingmei, senior medical affairs manager for Novo Nordisk in China, has been with the company since 2001 and has seen the company’s growth ﬁ rst hand. Novo Nordisk Annual Report 2008 25 Business environment Universal principles guide action Universal principles guide action Harnessing the potential of markets and business by putting values into ac- tion is the basis of the United Nations Global Compact. Novo Nordisk has been a subscriber and an active sup- porter since 2001, and the Compact’s 10 principles for responsible business are incorporated into the company’s governance framework, the Novo Nordisk Way of Management. Acting with integrity in the market place is paramount to earn trust and win stakeholders’ conﬁ dence. Novo Nordisk’s sustainability-driven approach aims to se- cure the company’s licence to operate and innovate. It also drives performance and sparks innovation across the value chain. UN Global Compact as a strategic frame The UN Global Compact’s 10 principles on human rights, labour rights, environment and anticorruption are well aligned with the Novo Nordisk Way of Management (see p 20). The company’s annual commu- nication on progress accounts for achieve- ments and challenges in relation to the business and within its sphere of inﬂ uence. In 2008, Novo Nordisk continued to drive company-wide initiatives in respect of these principles across the value chain. Some of these are described below and on the following pages. Respect for human rights In 1998, Novo Nordisk was among the ﬁ rst companies to publicly declare support for the United Nations Universal Declara- tion of Human Rights and include respect for human rights into its principles of do- ing business. 2008 was the 60th anniver- sary of this declaration, and Novo Nordisk marked the occasion, along with its partners in Business Leaders Initiative on Human Rights, chaired by Mary Robinson, president of Realizing Rights. Standards for responsible sourcing Novo Nordisk has implemented global standards for responsible sourcing in a ﬁ rst phase, asking direct spend suppli- 26 Novo Nordisk Annual Report 2008 ers to document performance in terms of compliance with laws and regulations, environment, health and safety, labour practices, ethics and subsuppliers. Expand- ing the reach to all of the company’s approximately 38,000 suppliers requires a robust methodology to identify and assess relative levels of commercial and reputa- tional risk. This work began in 2008 and will be completed in 2009, with the aim of segmenting suppliers into high-, medium- and low-risk groups. A correlating audit system undertakes prescreenings with new suppliers and audits. “Respect for human rights is relevant to our business in several ways. It guides our approach to improving access to health, promoting diversity in the workplace and managing risks in our supply chain.” Lise Kingo Executive vice president and chief of staffs High standards in bioethics In research and development, ethical standards for bioethics apply, and Novo Nordisk has a track record of leading this ﬁ eld. In 2008, the company advocated successfully for a new European Medicines Agency guideline on virus safety that postpones the requirement for animals in cell line testing until after phase 3 clinical trials. Since many products never reach that stage, this stipulation will reduce the number of animals used in the develop- ment of new pharmaceuticals in Europe. The guideline comes into force in February 2009. Business ethics compliance Novo Nordisk has established a Business Ethics Compliance ofﬁ ce to support and monitor the company’s business ethics policy and procedures, and manage training covering anticorruption, conﬂ icts of inter- est, promotion of pharmaceutical products, and interaction with healthcare profession- als, suppliers and intermediaries. These procedures were updated in 2008 to ensure the company’s public affairs work is consistent with its values and in compliance with legal requirements. All managers must be trained in business ethics, and sales and marketing employees undergo annual training. In 2008, 99% of sales and marketing employees were trained. Compliance is overseen by Group Internal Audit, which conducts reviews of business units worldwide. In 2008, 25 reviews were conducted and recommen- dations are followed up. Measuring values-based orientation internally The risk of not living up to the Novo Nordisk Way of Management is greater for some activities than for others, and this relative risk determines the frequency of facilitations, the internal values audit pro cess. For some units, facilitations take place annually; for others, the process takes place once every three years. A consolidated report, covering the 45 facilitations undertaken in 2008, was pre- sented to the Board in December. These facilitations covered units representing about 9,000 employees, and more than 2,000 were interviewed to determine how corporate values are being lived and imple- mented throughout the organisation. The report concludes that there is a strong level of compliance with not just systems and procedures, but also the spirit of the Novo Nordisk Way of Management. Issues observed included opportunities to further improve employee development activities and ways to improve the company’s work climate. Business environment Diversity supports global growth Diversity supports global growth Effective globalisation of Novo Nordisk’s business operations is a precondition for further develop- ment and growth. A new diversity strategy aims to leverage individuals’ unique perspectives, talents and skills to strengthen teams’ ability to deliver competitive business results. Diverse management teams are best suited to promote globalisation and drive perform- ance. This is the underlying assumption of the company’s renewed diversity strategy. Inclusion is an integral element; the key to success is valuing and utilising differences. In a ﬁ rst phase the focus will be on foster- ing gender and nationality diversity in management teams. Taking a ﬁ ve-year perspective, the aspiration is that all senior management teams should be diverse in gender and nationality. Currently, 12 of 28 senior management teams include men, women, locals and non-locals. To Tamara Turman, a sales representative in the US, provides doctors with information in different languages to help patients with diverse backgrounds. bring the remaining teams in line with this objective, a number of supporting actions are being introduced. stakeholders, it is critical to be able to at- tract, retain and develop talented people from diverse backgrounds. Best individual for the position Selecting the best individual for a particular position remains the primary principle for recruitment. Secondly, ensuring equal op- portunities and non-discrimination is part of the company’s values-based framework. Greater transparency and a peer chal- lenger function are being introduced for this process, which includes succession lists and preparation of individuals through development plans. From 2009, inclusion of men, women, locals and non-locals must be considered for succession lists for all key positions. Mentorship will be offered and supportive network initiatives including expatriate networks and a ‘family-buddy’ system is being set up. A network established in the US in 2007, Women in Novo Nordisk (WINN), is being replicated in other re- gions to support women’s career develop- ment throughout the company. Training in diversity and cultural inclu- sion is also offered to all employees and is integrated in the company’s leadership development programmes for managers, vice presidents and young talent to build leadership capabilities and a global mind- set. In 2008, nearly 500 new managers went through a four-day personal leader- ship programme. The outcome of these measures will be tracked through key performance indica- tors and assessed through the annual organisational audit process. Strong global growth can best be sup- ported by a diverse team that reﬂ ects the diversity of the company’s customers. The majority of the nearly 3,500 new employ- ees hired in 2008, about 75%, work in the company’s expanding afﬁ liates. Projections indicate a particular need to recruit people for research and development activites, and sales and marketing. Notably, the majority of the company’s workforce growth over the next decade will be outside Denmark. Recruiting talent To attract the best talent as the company grows rapidly, Novo Nordisk invests in strengthening its proﬁ le at leading univer- sities in key markets. In 2008, the com- pany expanded its Graduate Programme to China, where university graduates work for three eight-month stints at different lo- cations, including locations in both China and Denmark. A great place to work The annual global work climate survey, eVoice, shows that people at Novo Nordisk are highly engaged. On an index that mea- sures employees’ level of engagement by 10 criteria, the average score was 4.2 on a scale of 1 to 5, with 5 being the highest. The company’s commitment to ﬁ ght diabetes and the way it takes social and environmental responsibility are particu- larly motivating to employees. The Novo Nordisk values, global standards and the opportunity for a life-changing career are the building blocks for the company’s recent employer-branding initiative. Expanding workforce globally For Novo Nordisk to continue to innovate and grow globally, the quality of its people is the competitive factor. Novo Nordisk is committed to managing in a socially re- sponsible manner by caring for the people who rely on the company’s products as well as employees. To successfully create long-term value and relationships with “The company culture, the opportunity to save people’s lives, to make a difference in society, and to grow personally and professionally: this is the employer value proposition that differentiates Novo Nor- disk. It also reﬂ ects what many of today’s job applicants seek in an employer,” says Lars Christian Lassen, senior vice presi- dent, Corporate People & Organisation. Novo Nordisk Annual Report 2008 27 Business environment Strengthening environmental management Strengthening environmental management Through prudent use of nature’s resources since the early 1990s, Novo Nordisk has achieved improvements in eco-productivity. Efﬁ cient resource consumption reduces environmental impacts and lowers costs for both the company and society. The correlation between sound environ- mental management and cost optimisa- tion is a well-established business case for a broader business perspective. Now Novo Nordisk’s updated strategy for environ- ment, health and safety raises the bar. The company expects to continue to increase production. This means being able to provide treatment for more patients while decreasing environmental impacts and reducing the frequency of occupational injuries. Progress towards the ambitious target of achieving an absolute 10% reduction in 2004 CO2 emissions by 2014 demon- strates that it is possible to reduce energy consumption while increasing produc- tion. Similar absolute reduction targets have now been set for energy and water consumption, frequency of occupational injuries and injury severity. CO2 emissions fell for the ﬁ rst time in 2008, achieving a 9% reduction compared to 2007. Climate action shows results Novo Nordisk’s climate strategy aims to reduce carbon-based fuel dependency and demonstrate leadership. It hinges on three levers: continued efﬁ ciency gains, energy savings and conversion to renew- able energy. While the strategy is global, particular focus has been on Danish pro- duction sites. The energy-intensive process of producing the active pharmaceutical ingredient for Novo Nordisk’s insulin prod- ucts takes place only in Denmark and in 2008 represented 85% of the company’s total CO2 emissions. tively simple facility management changes to optimise ventilation, the company has achieved signiﬁ cant energy savings and emission reductions. Nearly a quarter of the 112 energy-saving projects the company undertook during the year required no upfront investment, only changes in facility management. Half of the energy-saving projects undertaken globally in 2008 are expected to pay for themselves within one year, and two- thirds of the rest are expected to pay for themselves within three years. Novo Nordisk launched its pioneering partnership with its Danish energy supplier, DONG Energy, in 2007 to help identify energy savings and translate the ﬁ nancial value of these into new wind energy. The company’s objective was to use only green electricity for its Danish operations by 2014. Signiﬁ cant reductions in energy consumption, even as sales and production have increased, mean that this goal is expected to be achieved several years ahead of schedule. Pharmaceutical industry standards include stringent air quality requirements, so a large percentage of energy is used for ventilation and cooling. By making rela- Outside Denmark, the company’s Brazilian production facility in Montes Claros is now using biomass instead of fuel oil for steam production, bringing the facility close to CO2 neutral as the main electricity supply is based on hydropower. When running at full capacity, this plant will be the com- pany’s biggest insulin ﬁ lling facility. Novo Nordisk has also built signiﬁ cant energy and water efﬁ ciencies into the production facility currently under con- struction in Tianjin, China. The facility is expected to open in 2012, and as a result of eco-efﬁ cient design will need less energy than similar production facilities elsewhere. Climate change and health The World Health Organization’s new report on ‘The Social Determinants of Health’ is an extraordinary document. It spells out the dire consequences for socie- ties all over the world of the cumulative impact of today’s toxic ‘policy mix’ – a mix that has driven economic growth at all costs, increasing levels of inequality, trash- ing the environment, and bringing us to the brink of runaway climate change. The health impacts of climate change, particularly in developing and emerg- ing economies are already severe: more people suffering from water and food shortages, more people displaced from degraded lands or spreading deserts; insect-borne diseases expanding their range, and so on. The WHO estimates as many as 150,000 excess deaths a year from climate change. Understandably, scientists are cautious about claiming that any particular event Jonathon Porritt Founder director, Forum for the Future Novo Nordisk invited Jonathon Porritt to present his perspective on the connection between climate change and global health. 28 Novo Nordisk Annual Report 2008 Business environment Strengthening environmental management Credit for much of the company’s progress in resource management is due to the hard work and diligence of energy stew- ards placed throughout the organisation. In addition to implementing efﬁ ciency projects, the 30 energy stewards serve as challengers at the production facili- ties, looking for ways the company can improve. Updated strategy Following an assessment of the company’s performance, trend analysis and peer reviews, an updated strategy for environ- ment, health and safety at Novo Nordisk’s production sites highlights six focus areas: energy, water, waste, accidental releases, occupational injuries and ergonomics. The strategy sets three- to ﬁ ve-year targets in each of the areas, and action plans will be implemented in 2009. Credit for much of the company’s progress in resource management is due to the hard work and diligence of energy stewards. Reducing water usage Understanding and developing a com- prehensive plan for managing the company’s water footprint was another 2008 achievement. An absolute water reduction target has now been set, and detailed water mapping will be ﬁ nalised by 2012 at sites using the most water. The company’s ﬁ lling plants, particularly those outside Denmark, offer the biggest opportunities for reducing water usage per produced unit. Waste management next on list Performance improvements were seen in all of the company’s key environmental indicators in 2008 with the exception of waste. Efﬁ cient waste management is a challenge that will have to be tackled. A systematic assessment to better un- derstand the sources of waste and their impact will be undertaken with the aim of stabilising waste volumes. Certiﬁ ed health and safety management Novo Nordisk’s commitment to health and safety supports the company’s people- centred culture, which helps attract em- ployees and reduce staff turnover. All production units passed an OHSAS 18001 health and safety certiﬁ cation process in 2008. This required introduc- tion of health and safety stewards and workplace assessments at sites globally, as well as a more structured process for as- sessing health and safety risks. As a result, despite the company’s growth, job-related injuries fell during 2008, nearly reaching the company’s target for 2010. At the new facility construction in China, the health and safety target is a maximum of 10 injuries for every 1 million working hours, the company’s global target for produc- tion sites. Construction contractors must undergo regular inspections, have exten- sive safety training in place, investigate all work-related injuries and submit plans to avoid future injuries. is the direct consequence of climate change. After all, there have always been ﬂ oods and droughts, heat waves, forest ﬁ res, extreme air and water pollution events. But it is the increased incidence of such phenomena that is now being laid at the door of climate change – as with the dramatically increased incidence of forest ﬁ res in Mediterranean countries, for instance. The heat wave that hit France in August 2003 (leading to at least 30,000 additional premature deaths) exceeded ‘normal’ tem- perature ranges by such a huge margin that all scientists now attribute this directly to climate change. All that is just a taste of things to come. Accelerated climate change, whether in the rich world or the poor world, brings with it the prospect of increasingly serious health impacts. Public health practition- ers and sustainable development activists may still speak ‘different languages’, but they have everything to gain from working much more closely together. Governments need to make that happen in terms of joining up different policy areas (climate change, health, transport, education and so on), and businesses can make that happen by helping employ- ees and customers to understand that a healthy life has to be a low-carbon life. Frank Jensen-Maar discusses energy savings at Novo Nordisk’s production site in Hillerød, Denmark, with Johan Moltke of DONG Energy. Jonathon Porritt is co-founder of Forum for the Future, a leading sustainable devel- opment charity. He was appointed chair- man of the UK Sustainable Development Commission, the UK government’s prin- cipal source of independent advice across the sustainable development agenda, in July 2000. His latest books are Capitalism As If The World Matters and Globalism & Regionalism. Novo Nordisk Annual Report 2008 29 Diabetes care Changing diabetes is possible Rury Holman FRCP Professor of Diabetic Medicine, University of Oxford Novo Nordisk invited Rury Holman to discuss research that supports earlier insulin inititation for diabetes treatment. Limitations of existing diabetes treatment Despite the availability of many different treatment modalities for type 2 diabetes, two fundamental therapeutic issues have yet to be addressed. People with type 2 diabetes continue to have an excess cardiovascular morbidity and mortality, compared with the general population, and no single therapy is able to maintain good blood glucose control in the longer term. Individuals with type 2 diabetes are two to four times more likely to develop cardiovascular disease than non-diabetic individuals, even after adjustment for age, ethnicity, household income, cholesterol, blood pressure and smoking. 65% of people with diabetes continue to die from coronary heart disease or a stroke, despite cholesterol, blood pressure, smoking and other risk-reduction strategies. An open question is whether long-term good blood glucose control can further reduce cardiovascular risk in these individuals. The 20-year UK Prospective Diabetes Study (UKPDS) showed that improved blood glucose control reduced the risk of loss of vision and kidney damage but had only a marginal impact on coronary disease. Three new cardiovascular outcome trials of improved blood glucose control that 30 Novo Nordisk Annual Report 2008 reported in 2008 (ACCORD, ADVANCE and VADT) all showed small reductions in cardiovascular risk but none achieved statistical signiﬁ cance. Although inconclu- sive, these favourable trends are however in line with UKPDS data that suggest improving blood glucose control could result in a modest reduction in the risk of heart attacks (14% reduction for a 1% drop in HbA1c). The good news is that the new UKPDS 10-year post-trial monitoring data, also published in 2008, conﬁ rms the long-term cardiovascular beneﬁ ts of earlier improved blood glucose control with emerging risk reductions of 15% for heart attacks and 13% for death. The ACCORD trial, however, added a cautionary note with an unexpected 22% increased risk of death associated with overly aggressive glucose lowering in people with long- standing diabetes, many of whom already had cardiovascular disease. It is now clear that the achievement and maintenance of good glycaemic control should be a primary aim from the time diabetes is ﬁ rst diagnosed. The ACCORD, ADVANCE and VADT trials showed that sustained improved glucose control could be obtained with combinatorial use of currently available therapies but there remains a major unmet need for more dur- able glycaemic treatments. These should facilitate near-normal HbA1c levels without promoting weight gain or hypoglycaemia, be simple to administer without onerous glucose monitoring requirements and, crucially, have no long-term adverse ef- fects such as further increasing patients’ cardiovascular risk. Prof Rury Holman was the ﬁ rst Professor of Diabetic Medicine to be appointed at the University of Oxford. He is immedi- ate past Academic Chairman of the Ox- ford Centre for Diabetes, Endocrinology and Metabolism (OCDEM), Director of the University of Oxford Diabetes Trials Unit, and an Honorary Consultant Physi- cian to the Oxford Radcliffe Hospitals NHS Trust. He divides his time between clinical care of patients, teaching and his extensive research interests. He has published over 250 peer-reviewed manu- scripts and has designed and run many multicentre studies that focus primarily on the prevention, appropriate treat- ment and cardiovascular risk reduction of type 2 diabetes. Currently he Co- Chairs the NAVIGATOR and TECOS trials and is Chief Investigator of the 4-T, ACE and UKPDS trials. Changing diabetes is possible With effective insulin treatment peo- ple with diabetes can achieve good blood sugar control. The critical factor is for care providers to offer timely initiation and intensiﬁ cation. Achieving and maintaining good glycae- mic control is key to effective diabetes care, but many people with type 2 diabe- tes do not achieve treatment targets. Poor control can lead to late-stage complica- tions such as blindness, kidney disease and lower limb amputations. Novo Nordisk’s diabetes strategy is to pro- vide innovative treatments that improve quality of life and treatment outcomes for people with diabetes. In the near term, the main focus is a contin- ued drive to make Novo Nordisk’s portfolio of modern insulins available to more people and to ensure optimal treatment outcomes. For the individual, this means ‘treat to target’ – that is, keeping blood sugar levels stable within the recommended range. New treatment guidelines In October 2008, a new set of treatment guidelines for type 2 diabetes was issued jointly by a panel of experts from the American Diabetes Association and the European Association for the Study of Diabetes. For the initial treatment phase, the guidelines continue to suggest lifestyle changes – diet and exercise – and treat- ment with metformin. If glucose/glycaemic goals are not met or maintained over time, the guidelines recommend combining metformin with a basal insulin, such as long-acting Levemir®, with Glucagon-Like Peptide-1s (GLP-1s) as an alternative treatment option. GLP-1s are the class of diabetes treatment that includes liraglutide, a once-daily human analogue of the naturally occurring human hormone, submitted by Novo Nordisk for regulatory approval in the US, Europe, Japan and many other countries in 2008. As a third step, the guidelines call for a transition to intensive insulin treatment to maintain treatment targets. This may include adding a rapid-acting modern insulin at mealtimes, such as NovoRapid®, in addition to a basal insulin. Substantial innovation The use of GLP-1 as an option for early treatment is supported by clinical data and experience, including Novo Nor disk’s comprehensive LEAD™ programme (Liraglutide Effect and Action in Diabe- tes). LEAD™, a series of six randomised, controlled, double-blind studies conducted in more than 40 countries, involved about 4,000 patients with type 2 diabetes and inadequately controlled blood glucose. “High blood glucose levels lead to health complications. Unfortunately, better control has long been associated with hypoglycaemia and weight gain and it is known that some patients avoid treatment to avoid the associated weight gain.” Mads Krogsgaard Thomsen Chief science ofﬁ cer Liraglutide works by stimulating the release of insulin only when glucose levels become too high and by suppressing appetite. Data from a 52-week phase 3 study (LEAD™ 3) published in The Lancet showed that liraglutide, when taken alone, produces statistically signiﬁ cant and sustained improvements in blood sugar control in patients with early type 2 diabetes, as compared with glimepiride, a widely used oral antidiabetic drug. Treat- ment with liraglutide also led to weight loss, reduced systolic blood pressure and lower rates of hypoglycaemia1. See more at annualreport2008. novonordisk.com/how-we-perform/ responsible-business-practices/advocacy/ changing-diabetes.asp. Diabetes care Changing diabetes is possible Mads Krogsgaard Thomson, chief science ofﬁ cer, was interviewed during the 2008 meeting of the European Association for the Study of Diabetes. Focus on patients For people with diabetes, like Leena Irmeli Lallukka of Finland, achieving treatment targets and staying in good control is often a challenge. She was 44 with a demanding job as head of two day care centres when she was diagnosed with type 2 diabetes. Leena Irmeli Lallukka ﬁ rst tried to regulate her diabetes by following a healthy diet, but when her blood sugar levels were still too high, she was prescribed tablets and insulin to treat the condition. Now that she is combining exercise with a low-fat diet and proper medication, “I feel quite well,” she says. Still, she admits that managing her treat- ment can be difﬁ cult. “I don’t monitor my blood sugar level as often as I should. I want to lose more weight, and I would like to lower the stress I am feeling because of my work. Then I could eat better and exercise regularly.” In addition to advocating for treatment improvements and care access, Novo Nordisk encourages healthcare profes- sionals and policy-makers to adopt clini- cally validated solutions to support better self-management through the DAWN (Diabetes Attitudes Wishes and Needs) programme. The initiative, a collaboration with the International Diabetes Federation, the International Society for Pediatric and Adolescent Diabetes and an international expert advisory board, puts patients at the centre of diabetes care. Leena Irmeli Lallukka, who was diagnosed with type 2 diabetes at the age of 44, wishes she had more time for exercise. Novo Nordisk Annual Report 2008 31 Diabetes care Supporting individualised treatment options Supporting individualised treatment options At the end of 2008, Novo Nordisk was the global market leader in diabetes care with 52% of the total insulin market and 44% of the modern insulin market, both measured by volume. Market growth is expected to con- tinue and there is signiﬁ cant potential, particularly with modern insulins. Modern insulins are designed to mimic the body’s own physiological insulin regulation of blood glucose levels more closely than human insulin, resulting in better glucose control, low hypoglycaemia and increased convenience. Better regulation of blood glucose levels is associated with fewer serious complications and better treatment outcomes. Modern insulins are classiﬁ ed by how fast they start to work in the body and how long their effects last. Novo Nordisk offers a full portfolio of modern insulins covering fast-acting, long- acting and premixed modern insulins: • Levemir®, a soluble long-acting modern insulin for once-daily use. • NovoRapid® (NovoLog® in the US), a rapid-acting modern insulin to be used at mealtimes. • NovoMix® 30 (NovoLog® Mix 70/30 in the US), a dual-release modern insulin that covers both mealtime and basal requirements. Kåre Schultz, chief operating ofﬁ cer. 32 Novo Nordisk Annual Report 2008 Strategy to expand leadership The company’s commercial strategy is to expand its leadership within inject- able insulin, gain GLP-1 leadership and continue to offer innovations that ad- dress unmet medical needs. Two new generation insulins, which have ﬁ nalised phase 2 development, are designed to be even longer acting to improve treatment outcomes and provide more conven- ient therapy. If successfully brought to market, Novo Nordisk’s continued insulin leadership will be sustained when cur- rent modern insulin patents expire and biosimilar insulin analogues potentially enter the markets. “Our full portfolio of modern insulins and superior delivery devices offer treatment options for all people with diabetes.” Kåre Schultz Chief operating ofﬁ cer Novo Nordisk’s protein engineering exper- tise, combined with device competences, provides a strong base for continued leadership in diabetes care. Insulins and GLP-1s must currently be injected through the skin with the help of a pen device. Novo Nordisk’s advanced products within insulin delivery systems include FlexPen®, the world’s most used insulin delivery device. Development of new preﬁ lled and durable devices support new products and offers improved convenience. Research in this area includes new injection device platforms, insulin pumps, and oral admin- istration of GLP-1 and insulin. Pursuing options for treatment administration Sometimes clinical development does not lead to desired outcomes despite hard work and dedication. That was the case when in early 2008 Novo Nordisk announced it Diabetes key events 2008 • Novo Nordisk maintains global market leadership in diabetes care. • Novo Nordisk ﬁ les for regulatory approval of liraglutide in the US, Europe, Japan and many other countries. • Novo Nordisk researchers are nominated for Europe’s top innovation prize for engineering Levemir®. • Novo Nordisk launches the new generation of FlexPen® – the world’s most widely used preﬁ lled insulin pen. • NovoMix® 30 achieves block- buster status, with 1 billion US dollars in sales in a 12-month period. • Novo Nordisk discontinues the development of pulmonary projects. would discontinue its development of in- haled insulin and instead focus on research and development of a new generation of delivery systems and options such as oral administration. As a result, 360 employees at Novo Nordisk Delivery Technologies Inc. in Hayward, California, became redundant but all were offered other positions or outplacement assistance. The decision also brought to an end phase 3 clinical trials involving around 2,500 pa- tients in nearly 40 countries. Patients were switched to treatment alternatives recom- mended by their doctors. The decision was not due to safety concerns, but because it was found that fast-acting inhaled insulin, in the form it is known today, is unlikely to offer signiﬁ cant beneﬁ ts over injections with pen devices. Diabetes care Supporting individualised treatment options Diabetes care Sales development DKK billion Modern insulins Sales development DKK billion 50 40 30 20 10 0 18 15 12 9 6 3 0 2004 2005 2006 2007 2008 2004 2005 2006 2007 2008 Modern insulins (cid:116) Human insulins (cid:116) Insulin-related products (cid:116) Oral antidiabetic products (OAD) NovoRapid® (cid:116) NovoMix® (cid:116) Levemir® American Eric Howell, pictured with his mother Bobbi, has type 1 diabetes. Modern insulin portfolio update because weight gain is a common barrier to insulin initiation, according to diabetes experts. Levemir® available in 69 countries NovoRapid® in pumps for children Levemir® was launched in six countries in 2008, including Mexico and Algeria, bring- ing the total number of countries where it is marketed to 69. Two studies during 2008 conﬁ rmed the beneﬁ ts of Levemir®: a head-to-head study with an alternative treatment, insulin glargine, demonstrated that once daily is an effective dosing frequency for Levemir® and that Levemir® has a comparable blood glucose response to insulin glargine over a 24-hour period in patients with type 2 diabetes2. In the other study, Levemir® additionally demonstrated signiﬁ cant weight loss for overweight or obese type 2 patients being initiated into insulin treat- ment3. The weight advantage is important In 2008, the US regulatory authorities, FDA, approved NovoRapid® (NovoLog® is the brand name in the US) for infusion by external insulin pump in paediatric pa- tients between the ages of 4 and 18 years. NovoLog® is the ﬁ rst and only modern insulin approved for this use. Over 70% of patients reach target with NovoMix® 30 In 2008, results were published from IMPROVE™, one of the largest-ever ob- servational studies in diabetes, designed to assess the safety and effectiveness of NovoMix® 30 in type 2 diabetes. The study involved over 58,000 patients from 11 countries. Results showed that after six months of treatment with NovoMix® 30, 71% of patients reached the target HbA1c (a way of measuring blood glucose levels) of less than or equal to 7%. This was achieved with a 70% reduction in patient-reported major hypoglycaemic events and no signiﬁ cant weight gain4. At enrolment, more than half of all patients were in poor control, with an HbA1c of over 9%, signiﬁ cantly higher than the recommended target of less than 7%. FlexPen® simpliﬁ es treatment Because treatment compliance is closely linked to better health outcomes, the com- pany continues to develop more conveni- ent delivery systems that make it easier for patients to manage their condition and without interruption to their lives. These include FlexPen®, the world’s most used insulin delivery device5. Novo Nordisk launched a new generation of FlexPen® during 2008. Novo Nordisk Annual Report 2008 33 Diabetes care Setting an agenda for change Former Secretary-General of the UN Koﬁ Annan with Novo Nordisk’s Chief of staffs Lise Kingo at the ‘Unite to Change Diabetes’ Leadership Forum in Moscow. tion and spreads awareness of best treat- ment practices that can lead to improved outcomes. The second international Forum ‘Unite to Change Diabetes’ was held in Moscow in November 2008 at the initia- “Without tackling the diabetes epidemic which is now gripping our world, we will, I fear, ﬁ nd many of our ambitions for the future simply impossible to achieve.” Koﬁ Annan Former Secretary-General of the United Nations tive of the Russian Diabetes Federation. Koﬁ Annan, former secretary-general of the UN, gave the keynote address. “When people get involved, politicians of- ten ﬁ nd the courage to do the right thing,” he said, proposing the Global Fund for HIV/AIDS as a potential model for diabetes. Improving healthcare is a priority of the current Russian government. Diabetes and related complications are the third most common cause of death in the country, after cardiovascular disease and cancer. The forum was attended by about 300 healthcare professionals, regional govern- ment ofﬁ cials, and people representing international and national patient organi- sations. Participants adopted a resolution for improving quality of care and a pilot project was launched to improve diabetes screening and diagnosis with the aim of improving treatment outcomes. Setting an agenda for change Novo Nordisk’s promise of Changing Diabetes® underpins the company’s strategy in diabetes care. Three ambi- tions drive its efforts: give priority to people with diabetes, improve treat- ment outcomes and break the curve of the global diabetes pandemic. Through its Changing Diabetes® initiatives, Novo Nordisk supports the implementa- tion of the UN Resolution on Diabetes to secure the right to diabetes care. With its resolution, adopted in December 2006, the UN encourages member countries to develop national policies for the preven- tion, treatment and care of diabetes in line with the sustainable development of their healthcare systems. Give diabetes priority Putting diabetes on the health policy agenda is the aim of the Global Changing Diabetes® Leadership Forums spearheaded by Novo Nordisk. This initiative calls for ac- 34 Novo Nordisk Annual Report 2008 In 2009, Novo Nordisk will coordinate a Forum to address the diabetes challenge in China. Improving treatment The Novo Nordisk IMPROVE™ programme is a global medical and public awareness campaign seeking to engage stakehold- ers in solving the problem of inadequate treatment. The programme is backed by the Changing Diabetes® Barometer which identiﬁ es best practices for the preven- tion and management of diabetes. The Barometer provides a set of quality indica- tors deﬁ ned by international guidelines including targets for blood glucose, blood pressure, weight control and lipids. It also measures quality of life experienced by patients and direct and indirect healthcare expenditures. By creating more transpar- ency, it is the aim to give policy-makers and healthcare providers the best possible basis for making informed decisions about improving health outcomes while bringing down total costs. By the end of 2008, more than 70 coun- tries had submitted data for the Changing Diabetes® Barometer online world map, which goes live in 2009. The map shows the status of diabetes treatment and is a collaboration with the International Diabe- tes Federation. Where data is available, the map includes health economic data. One such case comes from the US where a study found that, due to higher medical expenditures and lost productivity, the total cost of diabetes in the United States exceeds 217 billion US dollars6. The research com- missioned by Novo Nordisk’s National Changing Diabetes® Programme shows that beyond the estimated 174 billion dollars that is widely accepted as the cost of diagnosed diabetes in 2007, other costs include 18 billion dollars spent on 6.3 million people with undiagnosed diabetes; 25 billion dollars for 57 million American adults with prediabetes; and 623 million dollars for the 180,000 pregnancies where diabetes during pregnancy is diagnosed. Breaking the curve With 380 million people predicted to be in need of diabetes care for the rest of their lives by 2025, this condition presents a signiﬁ cant challenge to socioeconomic development. Every 10 seconds two peo- ple develop diabetes, and one person dies from diabetes-related complications. In one generation, the prevalence of diabetes has increased sixfold worldwide. While diabetes is not yet a curable disease, it can be treated and, in many cases, it can even be prevented. Novo Nordisk's global awareness-raising campaign, which in- cludes the Changing Diabetes® Bus, drives awareness of the personal and societal risks of diabetes. Through its National Changing Diabetes® programmes, Novo Nordisk promotes better education of healthcare professionals and wider avail- ability of screening for diabetes symptoms to help save lives and signiﬁ cant costs long term. Capacity-building outreach is reported on pp 6–7. More than 40,000 people visited the Changing Diabetes® Village in Cairo on World Diabetes Day in 2008. Diabetes care Setting an agenda for change Making change happen in Turkey Increased prevalence of diabetes is particu- larly notable in emerging markets such as Turkey. The country’s move in 2004 from a central provision system to a free pharma- ceutical market with reimbursement made healthcare available to more people in a country where the national prevalence of diabetes is higher than the global average (7.8% versus 5.9%). An estimated 3.2 mil- lion people have the condition – a number expected to nearly double to 5.5 million by 2025. Many are in poor glycaemic control. In 2007, Turkey created a national plan for awareness and treatment of diabetes and initiated a Turkish Diabetes Control Project. The project’s aim is to educate physicians about better diabetes treatment. By the end of 2008, it had reached an estimated 700 physicians, 200 nurses and 750 patients. Novo Nordisk was a catalyst for these ac- tivities as part of its efforts to highlight dia- betes on Turkey’s healthcare agenda. Since establishing its afﬁ liate in Turkey in 1993, Novo Nordisk has collaborated closely with healthcare authorities, healthcare profes- sionals and patients on activities such as sponsoring information supplements, TV and radio programmes about diabetes, diabetes congresses for physicians, and meetings for people with diabetes to learn how to better manage the condition. Novo Nordisk is the insulin market leader in Turkey. Its basal insulin, Levemir®, has gained the highest market share in Turkey of all of the company’s top 10 markets. Motivation and engagement by employees is high, with an unusually low level of staff turnover. As in any fast-growing pharmaceutical market, there are challenges, including increased competition, pricing pressures and more regulation of the industry. Yet Turkey’s recognition of the need to apply resources to address diabetes and other chronic diseases serves as a model for other countries. “Improving diabetes care not only beneﬁ ts the quality of life for millions of people but also greatly reduces healthcare costs in the long run due to fewer complications and better health outcomes. This is what Changing Diabetes® is all about,” says Mads Bo Larsen, vice president of Novo Nor disk’s Near East business area and ge- neral manager of Novo Nordisk in Turkey. Novo Nordisk Annual Report 2008 35 Diabetes care Ensuring access to care Ensuring access to care Novo Nordisk leverages its history of building healthcare partnerships to create long-term solutions that have impacts far beyond the company’s own efforts. The company's approach to improved access aligns with the UN Global Compact principles in respect of human rights and the UN Millen- nium Development goals. Novo Nordisk's comprehensive pro- grammes in the ﬁ eld of diabetes care target disadvantaged communities and the most vulnerable populations with the least access to care. These groups include people living in the countries classiﬁ ed by the United Nations as least developed countries (LDCs); low-income groups in emerging economies; migrants in devel- oped countries; women and children. While affordability of care is a signiﬁ cant barrier, there are other obstacles that are just as critical. These include lack of awareness about diabetes, lack of knowledge among healthcare providers in diagnosing and treating the condition, too few hospitals and clinics equipped to treat diabetes, and a lack of national healthcare strategies to tackle the epidemic. Seeking to overcome these barriers, the company puts efforts into building sustainable solu- tions that provide immediate relief while also building long-term capacity. During the World Diabetes Foundation summit in India in 2008, Lars Rebien Sørensen, CEO, greeted the teacher of a course on healthy eating. 36 Novo Nordisk Annual Report 2008 Changing the future for children in Africa While access to insulin is generally difﬁ cult in poor countries, many children die in hospitals even where insulin is available. Parents often lack money to pay for trans- portation to hospitals. Because diabetes shows in children as an acute crisis, they are often misdiagnosed and given the wrong, sometimes fatal, treatment. In December 2008, Novo Nordisk an- nounced an ambitious ﬁ ve-year project to change the future of these children. The programme, called ‘Changing the Future for Children with Diabetes’, will begin in 2009 with an initial roll-out in Cameroon, Uganda, Tanzania, Guinea- Conakry and the Democratic Republic of Congo. A series of satellite centres will be set up around existing hospitals and clinics for diagnosis, patient education and registration, and healthcare training. Treatment, including free insulin, will also be provided. The programme, which supports the UN goal of reducing child mortality, builds on an approach the company began in Tanzania in 2006. Children with type 1 diabetes are referred to a Novo Nordisk- funded diabetes clinic for specialised care, which has led to dramatically decreased mortality. Emergency admissions have also dropped. The company hopes to reach 10,000 children by 2013 by expanding this approach. Improved pricing initiative Novo Nordisk has since 2001 been committed to improving access to care and essential medicines to people living in the least developed countries. One important initiative involves offering insulin to the public health systems in the least developed countries at or below a price of 20% of the average prices for insulin in the Western world. In 2008, the company launched pilot projects in six countries to ensure that people with diabetes actually beneﬁ t from prefer- ential pricing. These measures include reducing insulin prices on the private Diabetes care Ensuring access to care market, initiating discussions with local agents to reduce mark-ups, and working with governments to centralise insulin procurement. Women at higher risk Children born to mothers with gestational diabetes are eight times more likely to develop diabetes, and the mothers have a 70% risk of redeveloping diabetes. Novo Nordisk initiated a new focus on this issue along with the Danish Minister for Development Cooperation, the Global Al- liance for Women’s Health and the World Diabetes Foundation, at a leadership forum in 2008. Novo Nordisk, as part of its commitment to support the Millennium Development Goal on gender equality and women’s empowerment, is working with partners to conduct further research into women, diabetes and development. The company will also increase its focus on women and diabetes through other diabe- tes care activities in the developing world. These include screening programmes and awareness campaigns. See more at annualreport2008. novonordisk.com/how-we-perform/ access-to-health/default.asp. Anja Lægaard Almind, a lab technician at Novo Nordisk, volunteered at Tanzania’s second diabetes summer camp for children. The World Diabetes Foundation (WDF) In recognition of the World Diabetes Foundation’s (WDF’s) achievements during its ﬁ rst ﬁ ve years, shareholders of Novo Nordisk approved an additional donation of up to 575 million Danish kroner at the March 2008 Annual General Meeting for the next 10-year period. In addition, Novo Nordisk employees donated nearly 500,000 kroner in 2008 to support speciﬁ c WDF fundrais- ing projects. The WDF has funded 182 projects in 83 countries, focusing on awareness, education and capacity-build- ing at local, regional and global levels. The total project portfolio has reached 191.4 million US dollars of which 62.2 million dollars were donated by the WDF. A projection based on achievements to date indicates that the initiatives funded by the WDF will positively impact the lives of 66 million people. Performance indicators • 5,103,470 people have attended 4,427 • 2,876,565 people have been screened for diabetes. • 229,829 people have been treated at the 754 established clinics funded by the WDF. By the end of 2008, the WDF had sup- ported the training of 14,433 doctors, 12,835 nurses and 27,852 paramedics. In addition, more than 32,090 cases of diabetic retinopathy have been detected, and 21,991 eyes and 18,232 feet saved. screening camps. See more at worlddiabetesfoundation.org. Novo Nordisk Annual Report 2008 37 Biopharmaceuticals Focusing on strengths in biopharmaceuticals Focusing on strengths in biopharmaceuticals Novo Nordisk’s ambition is to offer products and services that make a dif- ference. Over the years, Novo Nordisk has built very specialised expertise in protein engineering and formulation. The company’s focus on haemophilia, inﬂ ammatory conditions, human growth hormone therapy and hor- mone replacement therapy builds on this expertise, as well as decades of experience with chronic and auto- immune conditions. Expanded haemophilia pipeline Since its introduction 12 years ago, NovoSeven® has been a ﬁ rst-line treatment for bleeding in haemophilia patients with inhibitors. Because of the effectiveness of NovoSeven® as a coagulant to stop bleed- ing, the company pursued regulatory ap- proval for the product in critical and severe bleeding. It was hoped that NovoSeven® could be used to reduce severe bleeding in cases where no other treatment exists, but the practical difﬁ culties of proving effectiveness for severe traumatic injuries in a way that would satisfy regulators led Novo Nordisk to discontinue this research in 2008. Biopharmaceuticals Sales development DKK billion 18 15 12 9 6 3 0 2004 2005 2006 2007 2008 Haemostasis management (NovoSeven®) (cid:116) Growth hormone therapy (cid:116) Hormone replacement therapy (cid:116) Other products 38 Novo Nordisk Annual Report 2008 The company has continued to introduce improvements that have made NovoSeven® more convenient, including the launch in 2008 of a room temperature-stable formulation, which may reduce the time to treatment both inside and outside home and hospital settings. NovoSeven® was developed to meet the needs of the ap- proximately 3,500 people with haemophilia worldwide who have developed inhibitors. Novo Nordisk’s ambition is also to develop new compounds based on other blood- clotting factors, offering treatment options to the more than 300,000 people with haemophilia A and B. Today, treatments for haemophilia require frequent intravenous infusions. Novo Nordisk’s pipeline includes work on both long-acting compounds allowing for less frequent treatment and products that support more convenient subcutaneous delivery. As part of the company’s expanded focus on general haemophilia, Novo Nordisk acquired intellectual property rights from its long-standing partner Neose Tech- nologies Inc. during 2008. Application of Neose’s proprietary GlycoPEGylation technology allows the half-life of proteins to be extended for less frequent treat- ment. Leveraging protein strengths to ﬁ ght inﬂ ammation In inﬂ ammation, Novo Nordisk’s protein heritage combined with its long experi- ence of management of chronic disease provides the company with a signiﬁ cant opportunity to address unmet medical needs. Many inﬂ ammatory conditions also have autoimmune characteristics with similarities to type 1 diabetes. Biopharmaceuticals key events 2008 • Novo Nordisk launches a temperature-stable formalation of NovoSeven®. • Novo Nordisk celebrates the 20th anniversary of the launch of Norditropin®. • Novo Nordisk launches a new inﬂ ammation R&D centre in Seattle. • Novo Nordisk begins phase 3 trials for a recombinant FXIII to treat congenital FXIII deﬁ ciency. • Novo Nordisk maintains market leadership with Vagifem®, the world’s best-selling topical oestrogen therapy. • Novo Nordisk discontinues phase 3 trials of NovoSeven® for trauma and consequently closes its haemostasis centre in New Brunswick, New Jersey, US, affecting 26 employees. • Novo Nordisk discontinues phase 3 trials of Norditropin® for patients with low serum albumin on dialysis (LSAD). “There are huge numbers of people with autoimmune inﬂ ammatory conditions that have unmet medical needs, even with the best existing therapies,” says Don Foster, head of the new Novo Nordisk inﬂ amma- tion discovery centre in Seattle. Novo Nordisk’s commitment to inﬂ amma- tion research and development is being pursued by leveraging R&D competences in Denmark while establishing a new, specialised R&D centre in Seattle, Wash- ington, US. By 2010, the company expects to have around 80 scientists working on inﬂ ammation at the US centre. In 2008, Novo Nordisk initiated phase 1 trials for anti-IL20 and anti-C5aR, com- pounds the company is developing for treatment of psoriatic arthritis, rheuma- toid arthritis and systemic lupus ery- thematosus. The company also entered into a collaboration agreement with VLST Corporation, a Seattle-based biotechnol- Biopharmaceuticals Focusing on strengths in biopharmaceuticals Patrick Moll, who has a growth disorder, lives with his parents in Wuppertal, Germany. 2007, does not currently have generic competition. Novo Nordisk’s long- standing position is that HRT should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. Novo Nordisk decided in October 2008 to discontinue the phase 3 study of Norditropin® in dialysis patients with low serum albumin, which was started in 2007. The decision to discontinue the study was due not to safety concerns, but to difﬁ culties in recruitment of pa- tients for the study, which was expec ted to impact study outcomes. Topical oestrogen and low-dose hormone replacement therapy Novo Nordisk is also expanding market leadership with Vagifem®, the world’s best-selling topical oestrogen therapy. ogy company. Novo Nordisk and VLST will jointly undertake a research pro- gramme to identify collaboration targets and develop product candidates within the ﬁ eld of autoimmune and inﬂ amma- tory disorders. Market leadership in human growth hormone Novo Nordisk is on its way to becoming the world’s leading company within the human growth hormone segment, driven by solid sales of Norditropin®, the only liquid growth hormone product that does not require refrigeration and is available in a preﬁ lled device, ready to use. Novo Nordisk’s advanced device technol- ogy is used for Norditropin®. Years of re- search have gone into ﬁ nding the simplest and most convenient ways to inject pro- tein molecules and, across product lines, the strategy is to provide improvements in compound formulations, along with easy- to-use device systems for optimal treat- ment outcomes. Sales of Norditropin® have increased by 12% annually over the past ﬁ ve years and the treatment is the best-selling human growth hormone therapy in many mar- kets. Long-acting once-weekly human growth hormone in a preﬁ lled device is in the pipeline. In 2008, Norditropin® was approved in the US for the treatment of short stature in children born small for gestational age (SGA). Approximately 100,000 children are born annually in the US with this diag- nosis, which is characterised by very low relative birth weight. A 13-year clinical trial of children born SGA found that, when treated with Norditropin®, 63% reached normal height by adulthood. Growth hormone therapy Global value market share % 30 25 20 15 10 5 0 2006 2007 2008 2005 2004 (cid:116) Norditropin® Generic competition for Activelle® (Activella® 1.0 mg/0.5 mg in the US) since mid-2008 has eroded the com- pany’s market share in the US. However, Activella® 0.5 mg/0.1 mg, launched in Don Foster is the head of Novo Nordisk Inﬂ am- mation Research Center in Seattle. He is an expert in autoimmunity and coagulation biology, has published over 120 scientiﬁ c papers and is the author of 45 issued patents. Novo Nordisk Annual Report 2008 39 Biopharmaceuticals Living with haemophilia Paul Mahoney, pictured near his home in England, has haemophilia with inhibitors. Living with haemophilia Paul Mahoney has had haemophilia with inhibitors as far back as he can remember but it hasn’t slowed him down. “I have never wrapped myself up in cotton wool and subsequently suffered from lots of bleeds,” he says. When he was a boy, he had a wisdom tooth removed and it “just bled and bled – it was so serious that I got to a point when my life was in danger,” he recalls. As he got older, he learned to deal with the bleeds himself. “All my joints have their story to tell,” he says. “Some are more damaged than others but I get by and have no complaints. My attitude to haemophilia is to live and learn from it, and I heartily follow the old maxim ‘carpe diem’ – live for today.” Today Paul Mahoney leads an active life in a small seaside village in Cornwall, 40 Novo Nordisk Annual Report 2008 England, working as a web designer and pursuing wildlife photography and boat- ing. While he has developed arthritis as a consequence of his damaged joints, Paul Mahoney is grateful to have access to reli- able treatment. “My body allows me to do most things I want. Obviously as I get older it becomes less easy. But then that’s true for everyone to some degree. I reckon the world is out there, and it’s up to me to take advantage of all it has to offer.” For more than a decade, Novo Nordisk has revolutionised treatment for people like Paul Mahoney with haemophilia with inhibitors. He uses NovoSeven®, which remains the only recombinant treat- ment available to people with inhibitors. In 2008, he began using the new room temperature-stable NovoSeven®, which does not need to be refrigerated. “I lead a pretty active life, and particularly love sailing, so being able to get hold of my treatment as soon as I need it is a big help. Plus I have a smaller volume to inject, which means less discomfort each time I treat a bleed.” Paul Mahoney Haemophilia patient Biopharmaceuticals Changing possibilities for people with haemophilia Changing possibilities for people with haemophilia Novo Nordisk’s research and develop- ment efforts targeting haemophilia with inhibitors began 20 years ago and today NovoSeven® is still the only recombinant medication available. Novo Nordisk’s understanding of the needs of people with haemophilia, both those with and without inhibitors, is reﬂ ected in the company’s commitment to changing possibilities for all people with haemophilia. Backed by an ambitious clinical development programme, Novo Nordisk is building one of the broad- est haemophilia portfolios in the industry. Novo Nordisk has a heritage of working to improve existing standards of care by facil- itating education, awareness and training for physicians, patients and caregivers. In the US, the company offers a range of educational grants and individual achieve- ment awards, and general information for patients on the changingpossibilities-us. com website. SevenSecure® is an assist- ance programme offering ﬁ nancial and insurance support to people with haemo- philia with inhibitors. Novo Nordisk collaborates with the French national association for haemophilia patients to support roundtable meetings among patients and healthcare profession- als about treatment and the challenges of living with the condition. In South Africa, where haemophilia remains largely undiagnosed and often poorly managed, Novo Nordisk in 2008 sponsored a mobile education unit in col- laboration with the South African Haemo- philia Foundation and the Department of Health. More than 1,300 South Africans were screened for haemophilia in 2008 as a result of this programme. Peter Sinclair, pictured with his family, has lived with haemophilia for more than 40 years. The Novo Nordisk Haemophilia Foundation Haemophilia is a neglected and non- prioritised disease in the developing world, where 75% of people with the condition live. Many of them suffer serious compli- cations and premature death. By working to build a network of partners around the world who can share experiences and bet- ter practices, the Novo Nordisk Haemo- philia Foundation (NNHF) helps to improve the care and treatment of patients with haemophilia and related bleeding dis- orders. The activities the NNHF supports include capacity-building, awareness crea- tion and disease impact reduction. The NNHF partners with healthcare profes- sionals, patient organisations and health ministries to carry out projects. In 2008, it supported 25 projects in 22 countries in many regions of the world, including South America, North Africa, South Africa, Asia, the Middle East and Eastern Europe. Four fellowships were awarded in 2008 to physicians from China, Iraq and Thailand for further training in haemophilia diagnosis and bleeding disorder management. In Venezuela, the NNHF expanded haemo- philia care into rural areas, where it was largely unavailable. A multidisciplinary team focused on patient and physician education and improving cooperation be- tween patient associations and their local hospitals, and beneﬁ ting about 1,300 pa- tients and their families. The programme covered the entire country, increased the diagnosis of known haemophilia patients from around 1,300 to more than 1,700, and trained 250 healthcare professionals. The result is a stronger haemophilia care system, increased awareness and the for- mation of a national haemophilia network. In the NNHF project in Poland, haemo- philia care was decentralised from two centres in Warsaw to a further 17 regional blood centres, and a newly established group of haemophilia experts developed national treatment guidelines for haemo- philia. Almost 500 medical professionals received training, and a diagnostic cam- paign screened over 1,000 people, who were then registered. See more at nnhf.org. Novo Nordisk Annual Report 2008 41 Shareholder information Corporate governance Corporate governance Novo Nordisk is part of the Novo Group, a family of independent com- panies with a common history and shared values. The Novo Group com- prises a holding company, Novo A/S, wholly owned by the Novo Nordisk Foundation. Corporate governance refers to the way a company is managed and controlled, and the major principles and frameworks that regulate interaction between the com- pany’s managerial bodies, its owners and other stakeholders. Framework The framework for Novo Nordisk’s corporate governance system consists of external regu- lation and codes, and internal principles. Novo Nordisk is in compliance with applica- ble securities laws in Denmark, the US and the UK. The company is also in full compli- ance with the Danish Corporate Govern- ance Recommendations and is in general compliance with corporate governance standards as a foreign listed issuer on the New York and London stock exchanges. Novo Nordisk’s values are consistent with principles of good governance, and The Novo Nordisk Way of Management forms the internal values-based governance framework (see p 20). Governance Accountability to shareholders Novo Nordisk holds itself accountable to shareholders for its performance. The com- pany seeks to enhance the accuracy, com- pleteness and reliability of the information provided in the company’s annual ﬁ nancial and non-ﬁ nancial reporting through internal controls, assurance and independent audits. Reporting helps shareholders assess the ac- tions of the Board and management. liability company wholly owned by the Novo Nordisk Foundation, which is a com- mercial, proﬁ t-making foundation. The B shares are traded on the stock exchanges in Copenhagen and London and in the form of ADRs on the New York Stock Exchange. Each A share (= nominal value 1 Danish krone) carries 1,000 votes and each B share (= nominal value 1 Danish krone) carries 100 votes (see p 50). Special rights attached to A shares include preemptive subscription rights in case of an increase of the A share capital and pre- emptive purchase rights in case of a sale of A shares and priority dividend if divi- dend is below 0.5%, while B shares take priority for dividend between 0.5% and 5% and B shares take priority for winding up proceedings. Novo Nordisk is of the opinion that the current share and ownership structure is appropriate for the long-term develop- ment of the company. The company’s transparent share structure beneﬁ ts share- holders, who know in advance the relative voting power of each share class. Novo Nordisk is not aware of the existence of any agreements with or between share- holders on the exercise of votes or control. Shareholders have ultimate authority over the company and exercise their right to make decisions regarding Novo Nordisk at general meetings, either in person or by proxy. Resolutions can generally be passed by a simple majority, while resolutions to amend the articles are subject to adoption by at least two-thirds of votes cast and capital represented unless stricter require- ments are imposed by Danish company law. At the annual general meeting, share- holders approve the annual report and any amendments to the company's articles. They also elect board members and the independent auditor. Shareholder rights Novo Nordisk’s share capital is divided be- tween A shares and B shares. All A shares are held by Novo A/S, a Danish limited All shareholders may, no later than 1 Feb- ruary, request that proposals for resolution be included on the agenda. All sharehold- ers may also ask questions at the general meetings. Simultaneous interpretation between English and Danish is available, and the meeting is webcast live. The Novo Nordisk Foundation The Foundation supports Novo Nordisk in achieving its vision and adhering to the Charter for Companies in the Novo Group. All strategic and operational matters are solely decided by the Board and the man- agement of Novo Nordisk. Overlapping board memberships help to ensure that the Foundation and Novo Nordisk share a common vision and strategy. Board of Directors The company has a two-tier board structure consisting of the Board of Directors and Executive Management. The two bodies are separate and no person serves as a member of both. On behalf of the shareholders, the Board determines the company’s overall strategy and actively contributes to develop- ing the company as a focused global phar- maceutical company. The Board supervises Executive Management in its decisions and operations and may issue new shares or buy back shares in accordance with authorisa- tions granted by the general meeting and recorded in the minutes. The Board currently has 11 members, seven of whom are elected by shareholders at general meetings and four by employees. Shareholder-elected board members serve a one-year term and may be re-elected at the general meeting. Board members must retire at the ﬁ rst general meeting after reaching the age of 70. A proposal for nomination of shareholder-elected board members is presented by the Chairmanship to the Board, taking into account required competences and reﬂ ecting the result of a self-assessment process. The assessment process is based on written questionnaires and evaluates whether each board member and executive participates actively in board discussions and contributes with indepen- dent judgement. The Audit Committee conducts a similar self-assessment. In nominating candidates, the Chairman- ship seeks to achieve a balance between 42 Novo Nordisk Annual Report 2008 Shareholder information Corporate governance renewal and continuity. Executive search has helped identify board members who meet such criteria. Four of the sharehold- er-elected board members are indepen- dent as deﬁ ned by the Danish Corporate Governance Recommendations, while three shareholder-elected board members are related to the majority shareholder through board or executive positions, and two of these have also previously been ex- ecutives in Novo Nordisk (see pp 46–47). Under Danish law, Novo Nordisk em- ployees in Denmark are entitled to be represented by half of the total number of board members elected at the gen- eral meeting. Board members elected by employees serve a four-year term and have the same rights, duties and responsibilities as shareholder-elected board members. In 2008, the Board met eight times and all board members attended all board meet- ings and the Annual General Meeting, except for two occasions where one and two members, respectively, were excused. With the exception of agenda items reserved for the Board’s internal discus- sion at each meeting, executives attend and may speak, without voting rights, at board meetings to ensure that the Board is adequately informed of the company’s operations. Executives’ regular feedback from meetings with investors allows board members an insight into major sharehold- ers’ views of Novo Nordisk. Chairmanship A chairman and a vice chairman elected by the Board from among its members form the Chairmanship of the Board. In 2008, the Chairmanship held seven meetings and both members participated in all meetings. The Chairmanship carries out administrative tasks, such as plan- ning board meetings to ensure a balance between overall strategy-setting and ﬁ nancial and managerial supervision of the company. It also reviews the ﬁ xed asset investment portfolio. Other tasks include recommending the remuneration of directors and executives and suggesting candidates for election by the general meeting. In practice, the Chairmanship has the roles and responsi- bilities of a nomination committee and a remuneration committee. In March 2008, the Board re-elected Sten Scheibye chairman and Göran A Ando vice chairman. Research and development facilitator The Board has appointed a research and development facilitator to assist the Board and Executive Management in preparing the Board’s discussions about research and development. The key tasks are review- ing R&D strategies and evaluating the competitiveness of the R&D organisation, processes and projects. In March 2008, the Board re-elected Göran A Ando as R&D facilitator. Audit Committee The Audit Committee currently has two members elected by the Board from among its members. Both members qualify as independent as deﬁ ned by the US Securities and Exchange Commission (SEC). In 2008, the Audit Committee held The Novo Nordisk model of corporate governance Framework Shareholders Governance structure External codes and regulations Novo Nordisk Way of Management Board of Directors Chairmanship Audit Committee R&D Facilitator Executive Management Organisation Assurance and follow-up methodology Financial audit and non-ﬁ nancial assurance Facilitation Organisational audit Quality audit The Novo Nordisk corporate governance model sets the direction and is the framework within which the com pany is managed (see also p 20). four meetings and both members partici- pated in all meetings. The Audit Committee assists the Board of Directors with oversight of: • The external auditors • The internal audit function • The procedure for handling complaints regarding accounting, internal account- ing controls, auditing or ﬁ nancial report- ing matters and business ethics matters (‘whistleblower function’) • The ﬁ nancial reporting process includ- ing the effectiveness of the systems of internal controls, risk management and the accounting policies • Post-completion reviews and post- investment reviews of investments In March 2008, the Board re-elected Kurt Anker Nielsen as chairman and Audit Committee ﬁ nancial expert (as deﬁ ned by the SEC) and re-elected Jørgen Wedel as a member of the Audit Committee. In Janu- ary 2009, the Board designated Jørgen Wedel as ﬁ nancial expert (as deﬁ ned by the SEC). Hotline support (whistleblower programme) Concerns over possible breaches of ethical business conduct and ﬁ nancial fraud may be raised anonymously to the Audit Com- mittee by telephone or on the web in nine languages, with no subsequent disciplinary or retaliatory action towards the whistle- blower. Corporate governance codes and practices Novo Nordisk is in compliance with the Danish Corporate Governance Recommendations and – as a foreign listed issuer – is in general compliance with the corporate governance standards of the stock exchanges in London and New York, where Novo Nordisk's B shares and ADRs respectively are listed: • NASDAQ OMX Copenhagen Danish Corporate Governance Recommendations (2008) • New York Stock Exchange Corporate Governance Standards (2008) • London Stock Exchange The Combined Code (2008) The applicable codes and a detailed review of Novo Nordisk’s compliance are available at annualreport2008.novonordisk.com/ who-we-are/corporate-governance/compliance. Novo Nordisk Annual Report 2008 43 Shareholder information Executive remuneration Each complaint, concern or other commu- nication is investigated and the Audit Com- mittee retains records of complaints. As the company wishes to encourage good faith reporting of any violation of this policy, while avoiding damage to the reputation of innocent persons initially suspected of wrongful misconduct, investigations are conducted in a conﬁ dential manner to the maximum extent consistent with a thor- ough and complete investigation. Management of the company The Board has delegated responsibility for day-to-day management to Executive Management. Executive Management consists of the president and chief execu- tive ofﬁ cer and four other executives (see p 48) and is responsible for organisation of the company as well as allocation of resources, determination and implementa- tion of strategies and policies, direction- setting and ensuring timely reporting and provision of information to the Board and the stakeholders of Novo Nordisk. Execu- tive Management meets at least once a month and often more frequently. Assurance External audit The company’s ﬁ nancial reporting and the internal controls over ﬁ nancial reporting processes are audited and assessed by an external auditor elected by the annual general meeting. The auditor acts in the interest of shareholders and the public (see p 114). The auditor reports any signiﬁ cant ﬁ ndings regarding accounting matters and any signiﬁ cant internal control deﬁ ciencies via the Audit Committee to the Board and in the auditor long-form report. As part of the company’s commitment to ﬁ nancial, environmental and social responsibility, Novo Nordisk voluntarily includes an assurance report for non- ﬁ nancial reporting in its annual report (see p 115). The assurance provider reviews whether the non-ﬁ nancial per- formance information included in the annual report is complete, covers aspects deemed to be material and is responsive to company stakeholders. Internal audit The Board appoints members of Executive Management and determines remu- neration. The Chairmanship reviews the performance of the executives. The internal audit function provides independent and objective assurance primarily within internal control and governance. To ensure that the function works indepen dently of management, its charter, audit plan and budget are approved by the Audit Committee chair- man. The Audit Committee must approve the appointment, remuneration and dismissal of the head of the internal audit function. Internal control Novo Nordisk’s risk management and internal controls in relation to ﬁ nancial processes are designed with the purpose of effectively controlling the risk of mate- rial misstatements. A detailed description of the implemented internal controls and risk management system in relation to ﬁ nancial reporting processes is available at novonordisk.com/about_us. Novo Nordisk is in compliance with US Sarbanes–Oxley Act section 404, which requires detailed documentation of the design and operation of ﬁ nancial report- ing processes. Novo Nordisk must ensure that there are no material weaknesses in the internal controls that could lead to a material misstatement in its ﬁ nancial reporting. The company’s conclusion and the auditor’s evaluation of these pro- cesses are included in its Form 20-F ﬁ ling to the US Securities and Exchange Com- mission. Executive remuneration Board members Remuneration of the Board of Directors is aligned with other major Danish compa- nies, and payments made to members of the Board are reported in detail on p 80. The remuneration of board members is approved by the annual general meeting in connection with the approval of the an- nual report and any proposed changes are announced in advance. Beginning in 2009, remuneration of board members will be a separate agenda item at the Annual General Meeting. Each board member receives a ﬁ xed fee per year. Board members receive a ﬁ xed amount (the base fee) while the Chair- manship receives a multiplier thereof: the chairman receives 2.5 times the base fee and the vice chairman 1.5 times. Service on the Audit Committee entitles members to additional payments of 0.5 times the base fee or, in the case of the committee chair, 1.25 times the base fee. Individual board members may take on speciﬁ c ad hoc tasks outside the normal assigned duties. In such cases the Board determines a ﬁ xed fee for the work. This is the case for the R&D facilitation. Expenses, such as travel and accommo- dation in relation to board meetings as well as relevant training, are reimbursed. It will be proposed at the 2009 Annual General Meeting that all board members residing outside Denmark be paid a ﬁ xed travel allowance per meeting attended in Denmark. No travel allowance will be paid to board members when attending board meetings outside Denmark. Board members are not offered stock op- tions, warrants or other incentive schemes. Executives Executive remuneration is proposed by the Chairmanship and requires the approval of the entire Board. Detailed reporting of 2008 executive pay appears on p 81. Levels are evaluated annually against a Danish benchmark of large companies with international activities. This informa- tion is supplemented by information on remuneration levels for similar positions in the international pharmaceutical industry. Executive remuneration packages consist of a base salary, a short-term cash bonus, a long-term share-based incentive, pen- sions and other beneﬁ ts. For executives being expatriated at the request of the company, the remuneration package is based on current Danish remuneration lev- els, including pension entitlements, while 44 Novo Nordisk Annual Report 2008 Shareholder information Executive remuneration a speciﬁ c expatriation package is added for the period of expatriation. The short-term cash incentive bonus may yield a maximum annual payout equal to four months’ ﬁ xed base salary plus pen- sion contribution. The long-term incentive programme may result in a maximum grant per year equal to eight months’ ﬁ xed base salary plus pension contribution. Base salary The base salary for each executive ac- counts for between 40% and 60% of the total value of the remuneration package. Short-term incentive programme The short-term incentive programme consists of a cash bonus linked to the achievement of predeﬁ ned functional and individual business targets for each executive. The targets for the chief execu- tive ofﬁ cer are set by the chairman of the Board, while targets for executive vice presidents are set by the chief executive ofﬁ cer. The chairman of the Board evaluates the degree of target achievement for each executive and presents this, along with proposed cash bonus payments, for ap- proval by the Board. Long-term incentive programme In January each year the Board decides whether to establish a long-term incen- tive programme for the calendar year. The programme is based on a calculation of shareholder value creation compared with budgeted performance. In line with Novo Nordisk’s long-term ﬁ nancial targets, the calculation of shareholder value creation is based on reported operating proﬁ t after tax reduced by a WACC-based (weighted average cost of capital) return requirement on average invested capital. Global remuneration strategy Novo Nordisk aspires to be an employer of choice. The company’s remunera- tion strategy aims to attract, retain and motivate employees around the world. Compensation is designed to be competi- tive and to align interests with those of shareholders. On a global basis, compensation packages are guided by ﬁ ve broad principles: • A total rewards approach In addition to base pay, incentives and beneﬁ ts, non-ﬁ nancial remuneration A proportion of the calculated shareholder value creation is allocated to a joint pool for the participants, which in addition to Executive Management include other senior managers. budget for a particular year. In the lock- up period the value of the joint pool will change depending on the development in the share price, aligning the interests of participants with those of shareholders. For executives the joint pool operates with a yearly maximum allocation per partici- pant equal to eight months’ ﬁ xed base salary plus pension contribution. The joint pool may, subject to the Board’s assess- ment, be reduced in the event of lower- than-planned performance in signiﬁ cant research and development projects or key sustainability projects. Targets for non- ﬁ nancial performance may include achieve- ment of certain milestones by set dates. Once the joint pool has been approved by the Board, the total cash amount is converted into Novo Nordisk B shares at market price. The market price is calcu- lated as the average trading price for Novo Nordisk B shares on NASDAQ OMX Copenhagen in the open trading window following the release of ﬁ nancial results for the year prior to the bonus year. The shares in the joint pool are allocated to the participants on a pro rata basis: the chief executive ofﬁ cer has three units, executive vice presidents have two units each and other members of the Senior Manage- ment Board have one unit each. Joint pool shares for a given year are locked up for three years before they are transferred to participants. If an executive resigns during the lock- up period, their shares will remain in the joint pool to the beneﬁ t of the other participants. In the lock-up period, the Board may remove shares from the joint pool in the event of lower-than-planned value creation in subsequent years if, for example, the economic proﬁ t falls below a predeﬁ ned threshold compared with the Pension The pension contribution for executives is between 25% and 30% of the ﬁ xed base salary including bonus. Other beneﬁ ts Non-monetary beneﬁ ts such as company car and phone are negotiated with each executive individually. In addition, the executives may participate in normal pro- grammes that are offered to Novo Nordisk employees. Severance In addition to their notice period, execu- tives are entitled, in the event of termina- tion, whether by Novo Nordisk or by the individual due to a merger, acquisition or takeover of Novo Nordisk, to a severance payment of 36 months’ ﬁ xed base salary plus pension contribution. In the event of termination by Novo Nordisk for other reasons, the severance payment is three months’ ﬁ xed base salary plus pension contribution per year of employment as an executive, but in no event less than 12 or more than 36 months’ ﬁ xed base salary plus pension contribution. The Remuneration Policy for Novo Nordisk Board members and Executive Manage- ment is available at novonordisk.com/ about_us/corporate_governance/remuner- ation.asp. Application of the Remunera- tion Policy in 2008 is described in notes 33 and 34 on pp 78–82. Remuneration for board members and Executive Manage- ment will be in accordance with this policy for 2009. This is also expected to be the case for 2010. such as continuing education, career progression and working environment are important elements of the ‘total rewards’ package. employee performance and remuneration. Variable pay is used to reward perform- ance, with base pay increases reﬂ ecting market conditions. • Market linked Salaries, incentives and beneﬁ ts are positioned and maintained at the level re- quired to be competitive in local markets, generally between the local market me- dian and upper quartile. Novo Nordisk also provides adequate life insurance, health- care and pension provisions irrespective of local competitive practice. • Performance linked There is a transparent, direct link between • Transparency Clear communication of remuneration programmes is a priority, and all costs as- sociated with compensation practices are known and publicly disclosed. • Flexibility Subject to corporate governance or legal requirements, ﬂ exibility is encouraged. Flexible solutions must be cost neutral to Novo Nordisk, and adequate levels of insurance must be maintained. Novo Nordisk Annual Report 2008 45 Shareholder information Board of Directors Board of Directors Sten Scheibye Chairman of the Board of Directors ing fellow of the American College of Rheumatology Enzymes Division in 1977. After a number of years in the US. Dr Ando serves as chairman of the Board of in various specialist and managerial positions within Novexel SA, France, as vice chairman of the Board of this area, Mr Gürtler was appointed corporate vice S*Bio Pte Ltd, Singapore, and as a board member of president of Human Resource Development in Novo Novo A/S, Denmark, Bio*One Capital Pte Ltd, Singa- Nordisk A/S in 1991, and in 1993 he was appointed pore, NicOx SA, France, Enzon Pharmaceuticals, Inc, corporate vice president of Health Care Production. US, and EUSA Pharma, UK, CBio Pte, Australia, and From 1996 to 2000, he was a member of Corpo- Albea Pharmaceuticals AG, Switzerland. Dr Ando also rate Management of Novo Nordisk A/S with special serves as a Senior Advisor to Essex Woodlands Health responsibility for Corporate Staffs. Ventures UK Ltd. and is chairman of the Scientiﬁ c Advisory Board, Southwest Michigan First, US. Mr Gürtler is chairman of the boards of Novozymes A/S, Copenhagen Airports A/S and COWI A/S, all of Dr Ando qualiﬁ ed as a medical doctor at Linköping Denmark. Medical University, Sweden, in 1973, and as a special- ist in general medicine at the same institution in 1978. Mr Gürtler has an MSc in Chemical Engineering from the Technical University of Denmark (1976). From 1995 to 2008, Mr Scheibye was president The special competences possessed by Dr Ando that and CEO of Coloplast A/S, Denmark. Before joining are important for the performance of his duties are The special competences possessed by Mr Gürtler Coloplast in 1993, Mr Scheibye served as senior vice his medical qualiﬁ cations and his extensive executive that are important for the performance of his duties president, sales and marketing in Leo Pharma A/S, background within the international pharmaceutical are his knowledge of the Novo Group’s business and Denmark. He joined Leo Pharma in 1981. Mr Scheibye industry. its policies and his knowledge of the international is chairman of the Board of Governors of DTU (the biotech industry. Technical University of Denmark) and a member of the Dr Ando became vice chairman of the Novo Nordisk boards of Danske Bank A/S, DADES A/S, the Industrial A/S Board in 2006. Dr Ando has also been designated Mortgage Fund and the Aase and Ejnar Danielsen Research and Deve lopment Facilitator by the Board of Foundation, all of Denmark. Furthermore, he is chair- Novo Nordisk A/S. Johnny Henriksen man of the Denmark–America Foundation and vice chairman of the Danish Fulbright Commission. Mr Scheibye has an MSc in Chemistry and Physics from 1978 and a PhD in Organic Chemistry from 1981, both from the University of Aarhus, Denmark, and a BComm from the Copenhagen Business School, Denmark, from 1983. Mr Scheibye is also an adjunct professor of ap- plied chemistry at the University of Aarhus. Kurt Briner Johnny Henriksen joined Novo Nordisk in January 1986 and currently works as an environmental adviser in Product Supply. The special competences possessed by Mr Scheibye Kurt Briner works as an independent consultant to Mr Henriksen has an MSc in Biology from the Univer- that are important for the performance of his du- the pharmaceutical and biotech industries and is a sity of Copenhagen, Denmark (1977). ties are his knowledge of the healthcare industry, board member of OM Pharma, Switzerland, Progenics particularly as relates to patients requiring chronic Pharmaceuticals Inc, US, and GALENICA SA, Switzer- care, and managerial skills relating to international land. From 1988 to 1998, he was president and CEO organisations. of Sanoﬁ Pharma, France. He has been chairman of the European Federation of Pharmaceutical Industries Mr Scheibye became vice chairman of the Board of and Associations (EFPIA). Mr Briner holds a Diploma Directors of Novo Nordisk A/S in 2004 and chairman of the Commercial Schools of Basel and Lausanne, in 2006. Switzerland. Pamela J Kirby Göran A Ando, MD Vice chairman of the Board of Directors The special competences possessed by Mr Briner that are important for the performance of his duties Pamela J Kirby is chairman of the Board of Scynexis are his executive background and knowledge of the Inc, US, and a board member of Smith & Nephew plc pharmaceutical and biotech industries as well as of and Informa plc, both UK. From 2001 to 2003, Dr global, particularly European pharmaceutical regula- Kirby was CEO of the contract research organisation Dr Ando was CEO of Celltech Group plc, UK, until 2004. He joined Celltech from Pharmacia, now Pﬁ zer, US, where he was executive vice president and president of R&D with additional responsibilities for manufacturing, IT, business development and M&A from 1995 to 2003. From 1989 to 1995, Dr Ando was medical director, moving to deputy R&D director and tions and policies. Henrik Gürtler Quintiles Transnational Corporation, US, and before that Dr Kirby was director of Global Strategic Mar- keting of F. Hoffman-La Roche Limited, Switzerland, from 1998 to 2001. From 1996 to 1998, Dr Kirby was commercial director at British Biotech plc, UK, and from 1979 to 1996 Dr Kirby was employed by Astra (now AstraZeneca) in various international positions, most recently as regional director/vice president Corporate Strategy, Marketing and Busi- ness Development. then R&D director of Glaxo Group, UK. He was also a Henrik Gürtler has been president and CEO of Novo Dr Kirby has a BSc in Pharmacology (1975) and a PhD member of the Glaxo Group Executive Committee. Dr A/S, Denmark, since 2000. He was employed by Novo in Clinical Pharmacology (1978), both from the Univer- Ando is a specialist in general medicine and a found- Industri A/S, Denmark, as an R&D chemist in the sity of London, UK. 46 Novo Nordisk Annual Report 2008 Shareholder information Board of Directors The special competences possessed by Dr Kirby that Mr Nielsen serves as chairman of the Board of Direc- union steward. Stig Strøbæk has been an employee- are important for the performance of her duties are tors of Collstrups Mindelegat, Denmark. Mr Nielsen elected member of the Board of Directors of the Novo her scientiﬁ c qualiﬁ cations and extensive executive has an MSc in Commerce and Business Administration Nordisk Foundation since 1998. Mr Strøbæk has a background within the international pharmaceutical from the Copenhagen Business School, Denmark diploma in electrical engineering and a diploma in and biotech industries, particularly as relates to mar- (1972). keting, strategic planning, clinical trials and lifecycle further training for board members from the Danish Employees’ Capital Pension Fund. management in relation to pharmaceutical products. The special competences possessed by Mr Nielsen Anne Marie Kverneland Anne Marie Kverneland joined Novo Nordisk in July 1981 as a laboratory technician and is currently work- ing as a full-time union steward. Ms Kverneland has a degree in medical laboratory technology from the Copenhagen University Hospital, Denmark (1980). Kurt Anker Nielsen that are important for the performance of his duties are his knowledge of Novo Nordisk A/S and its busi- nesses, his working knowledge of the global pharma- ceutical industry and his experience with accounting, ﬁ nancial and capital markets issues. Mr Nielsen has been chairman of the Audit Commit- tee at Novo Nordisk A/S since 2004 and is also desig- nated as ﬁ nancial expert (as deﬁ ned by the SEC)4. Søren Thuesen Pedersen Jørgen Wedel Jørgen Wedel was executive vice president of the Gillette Company, US, until 2001. He was responsible for Com- mercial Operations, International, and was a member of Gillette’s Corporate Management Group. From 2004 to 2008, he was a board member of ELOPAK AS, Norway. Mr Wedel has an MSc in Commerce and Business Administration from the Copenhagen Business School, Denmark, (1972), majoring in accounting and ﬁ nanc- ing, and an MBA from the University of Wisconsin, US, Søren Thuesen Pedersen joined Novo Nordisk in Janu- (1974). ary 1994 and is currently working as a specialist in Global Quality Development. The relevant special competences possessed by Mr Wedel that are important for the performance of Søren Thuesen Pedersen has been an employee- his duties are his background as a senior sales and elected member of the Board of Directors of the marketing executive in a global company within the Novo Nordisk Foundation since 2002. Mr Pedersen consumer goods industry, as well as particular insight has a BSc in Chemical Engineering from the Danish into the US market. In addition, he possesses compe- Kurt Anker Nielsen was initially employed in Novo Academy of Engineers (1988). tences in relation to auditing and accounting. Industri A/S in 1974 as an economist. He served as CFO and deputy CEO of Novo Nordisk A/S until 2000 and from 2000 to 2003, he was CEO of Novo A/S. He serves as vice chairman of the Board of Novozymes A/S and as a member of the boards of the Novo Nordisk Founda- tion, LifeCycle Pharma A/S, Denmark, and ZymoGenet- ics, Inc, US. He is chairman of the Board of Reliance A/S, Denmark, and a member of the boards of StatoilHydro ASA, Norway, and Vestas Wind Systems A/S, Denmark. In Novozymes A/S, LifeCycle Pharma A/S, ZymoGenet- Stig Strøbæk Mr Wedel has been a member of the Audit Commit- tee at Novo Nordisk A/S since 2005 and in January 2009 he was designated as ﬁ nancial expert (as deﬁ ned by the SEC)4. ics, Inc, StatoilHydro ASA and Vestas Wind Systems A/S Stig Strøbæk joined Novo Nordisk in 1992 as an he is also elected Audit Committee chairman. electrician, and is currently working as a full-time Name (male/female) Sten Scheibye (m) Göran A Ando (m) Kurt Briner (m) Henrik Gürtler (m) Johnny Henriksen2 (m) Pamela J Kirby (f) Anne Marie Kverneland2 (f) Kurt Anker Nielsen (m) Søren Thuesen Pedersen2 (m) Stig Strøbæk2 (m) Jørgen Wedel (m) First elected 2003 2005 2000 2005 2002 2008 2000 2000 2006 1998 2000 Term 2009 2009 2009 2009 2010 2009 2010 2009 2010 2010 2009 Nationality Danish Swedish Swiss Danish Danish British Danish Danish Danish Danish Danish Date of birth 03 Oct 1951 06 Mar 1949 18 Jul 1944 11 Aug 1953 19 Apr 1950 23 Sep 1953 24 Jul 1956 08 Aug 1945 18 Dec 1964 24 Jan 1964 10 Aug 1948 Independence3 Independent Not independent1 Independent Not independent1 Not independent Independent Not independent Not independent1, 4 Not independent Not independent Independent4 1 Member of management or the Board of Novo A/S or the Novo Nordisk Foundation. 2 Elected by employees of Novo Nordisk. 3 As deﬁ ned in Section V.4 of Recommendations for corporate governance designated by the NASDAQ OMX Copenhagen. 4 Mr Nielsen and Mr Wedel qualify as independent Audit Committee members as deﬁ ned by the US Securities and Exchange Commission (SEC). Novo Nordisk Annual Report 2008 47 Shareholder information Executive Management Executive Manage- ment Lars Rebien Sørensen President and chief executive ofﬁ cer (CEO) Lars Rebien Sørensen joined Novo Nordisk’s Enzymes Marketing in 1982. Over the years, he has been stationed in several countries, including the Middle East and the US. Mr Sø- rensen was appointed a member of Corporate Management in May 1994 and given special responsibility within Corporate Management for Health Care in December 1994. He was ap- pointed president and CEO in November 2000. Mr Sørensen is a member of the boards of ZymoGenetics, Inc, US, and DONG Energy A/S, Denmark, as well as a member of the Bertels- mann AG Supervisory Board, Germany. Mr Sørensen received the French award Chevalier de l’Ordre National de la Légion d’Honneur in 2005. Mr Sørensen has an MSc in Forestry from the Royal Veterinary and Agricultural University (now University of Copenhagen), Denmark, from 1981, and a BSc in International Econom- ics from the Copenhagen Business School, Denmark, from 1983. Since October 2007, Mr Sørensen has been adjunct professor at the Life Sciences Faculty of the University of Copenha- gen. Mr Sørensen is a Danish national, born on 10 October 1954. Jesper Brandgaard Executive vice president and chief ﬁ nancial ofﬁ cer (CFO) Kåre Schultz Executive vice president and chief operating ofﬁ cer (COO) Jesper Brandgaard joined Novo Nordisk in 1999 as corporate vice president of Corporate Finance and was appointed CFO in November 2000. He serves as chairman of the boards of Simcorp A/S, NNE Pharmaplan A/S and NNIT A/S, all in Denmark. Mr Brandgaard has an MSc in Economics and Auditing from 1990 as well as an MBA from 1995, both from the Copenha- gen Business School, Denmark. Mr Brandgaard is a Danish national, born on 12 October 1963. Kåre Schultz joined Novo Nordisk in 1989 as an economist in Health Care, Economy & Plan- ning. In November 2000, he was appointed chief of staffs. In March 2002, he took over the position of COO. Mr Schultz is a mem- ber of the Board of LEGO A/S, Denmark. Mr Schultz has an MSc in Economics from the University of Copenhagen, Denmark, from 1987. Mr Schultz is a Danish national, born on 21 May 1961. Lise Kingo Executive vice president and chief of staffs (COS) Mads Krogsgaard Thomsen Executive vice president and chief science ofﬁ cer (CSO) Lise Kingo joined Novo Nordisk’s Enzyme Promotion in 1988 and over the years worked to build up the company’s Triple Bottom Line approach. In 1999, Ms Kingo was appointed vice president, Stakeholder Relations. She was appointed executive vice president, Corporate Relations, in March 2002. Ms Kingo serves as chair of the board of Steno Diabetes Center A/S, Denmark. She is also associate professor at the Medical Faculty, Vrije Universiteit, Amster- dam, the Netherlands. Ms Kingo has a BA in Religions and a BA in Ancient Greek Art from the University of Aarhus, Denmark, from 1986, a BComm in Marketing Economics from the Copenhagen Business School, Denmark, from 1991, and an MSc in Responsibility and Busi- ness Practice from the University of Bath, UK, from 2000. Ms Kingo is a Danish national, born on 3 August 1961. Mads Krogsgaard Thomsen joined Novo Nordisk in 1991. He was appointed CSO in November 2000. He sits on the editorial boards of international journals and is a member of the Board of Cellartis AB, Sweden. Dr Thomsen has a DVM from the Royal Veteri- nary and Agricultural University (now the Uni- versity of Copenhagen), Denmark, from 1986, where he also obtained a PhD degree in 1989 and a DSc in 1991, and became adjunct profes- sor of pharmacology in 2000. He is a former president of the National Academy of Technical Sciences (ATV), Denmark. Dr Thomsen is a Dan- ish national, born on 27 December 1960. Other members of the Senior Management Board Jesper Bøving – DAPI & CMC Supply Kim Bundegaard – Facilitation & Group Internal Audit Flemming Dahl – Biopharmaceuticals Claus Eilersen – Japan & Oceania Peter Bonne Eriksen – Regulatory Affairs Lars Green – Corporate Finance Jerzy Gruhn – North America Susanne Hundsbæk-Pedersen – Devices & Sourcing Jesper Høiland – International Operations Lars Fruergaard Jørgensen – IT & Corporate Development Terje Kalland – Biopharmaceuticals Research Unit 48 Novo Nordisk Annual Report 2008 Lars Guldbæk Karlsen – Global Quality Jesper Kløve – Device Research & Development Per Kogut – NNIT Peter Kristensen – Global Development Peter Kurtzhals – Diabetes Research Unit Lars Christian Lassen – Corporate People & Organisation Patrick Loustau – Global Marketing Ole Ramsby – Legal Affairs Jakob Riis – Liraglutide Martins Soeters – Europe Kim Tosti – Diabetes Finished Products Per Valstorp – Product Supply Hans Ole Voigt – NNE Pharmaplan Shareholder information Shares and capital structure Shares and capital structure Novo Nordisk aims to communicate openly with stakeholders about the company’s ﬁ nancial and business development as well as strategies and targets. Through active dialogue, the company seeks to obtain fair and ef- ﬁ cient pricing of its shares. To keep investors updated on ﬁ nancial and operating performance as well as the progress of clinical programmes, Executive Management and Investor Relations travel extensively to meet institutional investors and attend investor conferences. This ensures that all investors with a major holding of Novo Nordisk shares can attend meetings on a regular basis and that a high number of smaller investors or poten- tial investors also have access. Roadshows are primarily, but not exclusively, held in major European and North American ﬁ nancial centres. A wide range of other investor activities are held during the year. Investors and ﬁ - nancial analysts are welcome to visit Novo Nordisk at the headquarters in Bagsværd, Denmark, as well as at regional head- quarters. In 2008, meetings with investor groups were held at regional headquarters in Princeton, US, Beijing, China, Moscow, Russia, and Tokyo, Japan. Investors and analysts are also invited every year to presentations of the most recent scientiﬁ c results in connection with the two major medical diabetes conferences, Ameri- can Diabetes Association and European Association for the Study of Diabetes. In September 2008, Novo Nordisk hosted its biennial Capital Markets Day at the com- pany’s production site in Hillerød, Denmark. At the Capital Markets Day, Executive Man- agement and senior management provided 120 investors and analysts with updates on the progress in both the diabetes care and biopharmaceuticals pipelines, on productiv- ity improvements in manufacturing and on Novo Nordisk’s strategic position in key markets and therapy areas. Presentations and webcasts from key investor events are available on Novo Nordisk’s website novonordisk.com/investors. 500 400 300 200 100 0 600 500 400 300 200 100 0 600 500 400 300 200 100 0 Price development and monthly turn- over of Novo Nordisk’s B shares on the NASDAQ OMX Copenhagen 2008 DKK DKK billion 15 12 9 6 3 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec (cid:116) Novo Nordisk’s B shares (prices in DKK) (cid:116) Turnover of B shares in DKK billion Price development of Novo Nordisk’s B shares relative to the MSCI Europe Health Care Index measured in DKK Index 1 January 2004 = 100 2005 2008 2006 2004 (cid:116) Novo Nordisk’s B shares (prices in DKK) (cid:116) MSCI Europe Health Care Index 2007 Price development of Novo Nordisk’s B shares relative to the MSCI US Health Care Index measured in USD Index 1 January 2004 = 100 2005 2008 2006 2004 (cid:116) Novo Nordisk’s B shares (prices in USD) (cid:116) MSCI US Health Care Index 2007 Share price performance Novo Nordisk's share price decreased by 19% from its 2007 close of DKK 335 to its 31 December 2008 close of DKK 271. This was signiﬁ cantly better than the 2008 performance of the NASDAQ OMX Copenhagen 20 Index, down 47%, and in line with the MSCI Europe Health Care In- dex, down 19%, both measured in Danish kroner. Measured in US dollars, the price of the Novo Nordisk B share decreased by 23%, in line with a US dollar loss of 24% for the MSCI US Health Care Index. Novo Nordisk’s stable share price develop- ment is perceived as a reﬂ ection of the company’s relatively solid position in a growing market with strong operating performance and ongoing progress in research and development. In 2008, factors believed to have impacted the share price positively include a solid operating performance bolstered by solid sales growth, driven by the strategically signiﬁ cant modern insulin products. Sub- stantial productivity increases, achieved through the production efﬁ ciency improvement programme cLEAN®, also contributed to a solid improvement in the gross margin of around 1.7 percentage points in 2008. Within research and development one key event during 2008 believed to strengthen the share price was the simultaneous ﬁ l- ing for regulatory approval of liraglutide in Europe and the US followed by ﬁ lings in Japan and other key markets. Another positive development was the comple- tion of phase 2 clinical development of the new generation of insulins NN1250 and NN5401, which are expected to enter pivotal phase 3 studies in the second half of 2009. The most signiﬁ cant factors believed to have impacted the share price adversely include the discontinuation of certain research and development projects. An- other factor was unfavourable currency developments, despite the substantial appreciation of some of Novo Nordisk’s key invoicing currencies, including the US dollar, in the second half of 2008. Finally, 2008 was also a year with increased regulatory uncertainty for new diabetes compounds. Capital structure The Board of Directors believes that the current capital and share structure of Novo Nordisk serves the interests of the share- holders and the company. In the event of excess capital after the funding of organic Novo Nordisk Annual Report 2008 49 Shareholder information Shares and capital structure growth opportunities and potential ac- quisitions, Novo Nordisk’s guiding policy is to return capital to investors through dividend payments and share repurchase programmes. As decided at the Annual General Meeting 2008, a reduction of the company’s B share capital, corresponding to approxi- mately 2% of the total share capital, was effected in June 2008 by cancellation of treasury shares. This enables Novo Nordisk to continue to buy back shares without exceeding the limit for a total holding of treasury shares of 10% of the total capital. In 2008, Novo Nordisk repurchased shares worth 4.7 billion Danish kroner, compared with 4.8 billion kroner in 2007. This is part of the ongoing share repurchase programme for the period 2006–2009. In connection with the release of results for both the ﬁ rst six months and the full year for 2008, the Board of Directors approved an increase of 1.0 billion kroner in the ongoing share repurchase programme, bringing the total share repurchase pro- gramme to 18.5 billion kroner. From 2008, the share repurchase programme is pri- marily conducted in accordance with the provisions of the European Commission’s Regulation no 2273/2003 of 22 December 2003, also known as the ‘Safe Harbour Regulation’. This programme gives the lead manager, J.P. Morgan Securities Ltd., mandate to purchase shares independently of Novo Nordisk A/S. As part of the agenda for the Annual Gen- eral Meeting 2009, the Board of Directors will propose a reduction of the company’s B share capital, corresponding to approxi- mately 2% of the total share capital, by cancellation of treasury shares. Share capital and ownership Novo Nordisk’s total share capital of 634,000,000 Danish kroner is divided into A share capital of nominally 107,487,200 kroner, and B share capital of nominally 526,512,800 kroner, of which 25,721,095 kroner is held as treasury shares (ﬁ gures as of 31 December 2008). Novo Nordisk’s A shares (each 1 krone) are non-listed shares and held by Novo A/S, a Danish public limited liability company which is 100% owned by the Novo Nordisk Foundation. According to the Articles of Association of the Foundation, the A shares cannot be divested by Novo A/S or the Foundation. In addition, as of 31 December 2008 Novo A/S held 54,182,800 kroner of B share capital. Each holding of 1 krone of the A share capital carries 1,000 votes. Each holding of 1 krone of the B share capital carries 100 votes. With 25.5% of the total 50 Novo Nordisk Annual Report 2008 share capital, Novo A/S controls 71.7% of the total number of votes, excluding treasury shares. The total market value of Novo Nordisk’s B shares excluding treasury shares was 135 billion kroner at the end of 2008. Novo Nordisk’s B shares are quoted on the NASDAQ OMX Copenhagen and the London Stock Exchange, and on the New York Stock Exchange in the form of ADRs. The B shares are traded in units of 1 Danish krone. The ratio of Novo Nordisk’s B shares to ADRs is 1:1. The B shares are issued to the bearer but may, on request, be registered in the holder’s name in Novo Nordisk’s register of shareholders. As Novo Nordisk B shares are in bearer form, no ofﬁ cial record of all shareholders exists. Based on the available sources of information on the company’s shareholders, it is estimated that Novo Nordisk’s shares at the end of 2008 were distributed as shown in the Breakdown of shareholders % of capital Novo A/S, Bagsværd, Denmark 26% (72% *) ) (cid:116) Novo Nordisk A/S 4% (0% *) ) (cid:116) Other 70% (28% *) ) *) % of votes, excl treasury shares Geographical distribution of share capital % of capital Denmark 50% (cid:116) UK 25% (cid:116) North America 19% (cid:116) Other 6% charts on this page. At the end of 2008, the free ﬂ oat was 70%. Form 20-F The Form 20-F Report for 2008 is ex- pected to be ﬁ led with the United States Securities and Exchange Commission in February 2009. The report can be down- loaded from novonordisk.com/investors. Payment of dividends Shareholders’ enquiries concerning dividend payments, transfer of share certiﬁ cates, consolidation of shareholder accounts and tracking of lost shares should be addressed to Novo Nordisk’s transfer agents (see inside back cover). For 2008, the proposed divi- dend payments for Novo Nordisk shares are illustrated in the table below. Novo Nordisk does not pay a dividend on its holding of treasury shares. The dividend for 2007 paid in March 2008 was 4.50 Danish kroner per share of 1 krone. Proposed dividend payment for 2008 A shares of DKK 1 B shares of DKK 1 ADRs DKK 6.00 DKK 6.00 DKK 6.00 Analyst coverage Novo Nordisk is currently covered by about 30 analysts, including the top global investment banks that regularly produce research reports about Novo Nordisk. A list of analysts covering Novo Nordisk can be found in the investor section of Novo Nordisk’s homepage. Internet Novo Nordisk’s homepage for investors is novonordisk.com/investors. It includes his- torical and updated information about Novo Nordisk’s activities: press releases from 1995 onwards, ﬁ nancial and non-ﬁ nancial results, a calendar of investor-relevant events, inves- tor presentations, background information and recent annual reports. Financial calendar 2009 Annual General Meeting 18 March 2009 Dividend Ex-dividend Record date Payment B shares 19 March 23 March 24 March ADRs 19 March 23 March 31 March Announcement of ﬁ nancial results First three months Half year Nine months Full year 30 April 6 August 29 October 2 February 2010 Consolidated ﬁ nancial and non-ﬁ nancial statements 2008 Consolidated ﬁ nancial and non-ﬁ nancial statements 2008 Pages 51–104 52 Consolidated income statement 53 Consolidated balance sheet 54 Consolidated cash ﬂ ow statement and ﬁ nancial resources 55 Consolidated statement of changes in equity 56 Notes: Accounting policies and other notes to the ﬁ nancial statements 89 Overview of non-ﬁ nancial reporting 90 Non-ﬁ nancial indicators and targets 91 Notes: Accounting policies and other notes to the non-ﬁ nancial data 100 Companies in the Novo Nordisk Group 102 Summary of ﬁ nancial data 2004– 2008 104 Quarterly ﬁ gures 2007 and 2008 (unaudited) Pages 105–112 105 Financial statements of the parent company Pages 113–115 113 Management statement 114 Auditor’s reports Novo Nordisk Annual Report 2008 51 Consolidated financial statements Consolidated income statement DKK million Sales Cost of goods sold Gross profit Sales and distribution costs Research and development costs – hereof costs related to discontinuation of all pulmonary diabetes projects Administrative expenses Licence fees and other operating income (net) Operating profit Share of profit/(loss) in associated companies Financial income Financial expenses Profit before income taxes Income taxes Net profit Basic earnings per share (DKK) Diluted earnings per share (DKK) Note 2008 2007 2006 4, 5, 25 6, 7 6, 7 6, 7 3 6, 7, 8 9 16 10 11 12 13 13 45,553 10,109 35,444 12,866 7,856 (325) 2,635 286 12,373 (124) 1,127 681 41,831 9,793 32,038 12,371 8,538 (1,325) 2,508 321 8,942 1,233 1,303 507 12,695 10,971 3,050 9,645 15.66 15.54 2,449 8,522 13.49 13.39 38,743 9,585 29,158 11,608 6,316 – 2,387 272 9,119 (260) 931 626 9,164 2,712 6,452 10.05 10.00 52 Novo Nordisk Annual Report 2008 DKK million Assets Intangible assets Property, plant and equipment Investments in associated companies Deferred income tax assets Other financial assets Total long-term assets Inventories Trade receivables Tax receivables Other receivables Marketable securities and financial derivatives Cash at bank and in hand Total current assets Total assets Equity and liabilities Share capital Treasury shares Retained earnings Other reserves Total equity Long-term debt Deferred income tax liabilities Retirement benefit obligations Other provisions Total long-term liabilities Short-term debt and financial derivatives Trade payables Tax payables Other liabilities Other provisions Total current liabilities Total liabilities Total equity and liabilities Consolidated financial statements Consolidated balance sheet Note 31 Dec 2008 31 Dec 2007 14 15 16 23 17 18 19 20 17 30 21 22 23 24 25 26 27 25 788 18,639 222 1,696 194 21,539 9,611 6,581 1,010 1,704 1,377 8,781 671 19,605 500 2,522 131 23,429 9,020 6,092 319 1,493 2,555 4,823 29,064 24,302 50,603 47,731 634 (26) 33,433 (1,062) 647 (26) 30,661 900 32,979 32,182 980 2,404 419 863 4,666 1,334 2,281 567 5,853 2,923 961 2,346 362 1,239 4,908 405 1,947 929 4,959 2,401 12,958 17,624 10,641 15,549 50,603 47,731 Novo Nordisk Annual Report 2008 53 Consolidated financial statements Consolidated cash flow statement and financial resources DKK million Net profit Adjustment for non-cash items: Income taxes Depreciation, amortisation and impairment losses Interest income and interest expenses Other adjustments for non-cash items Income taxes paid Interest received Interest paid Note 2008 2007 2006 9,645 8,522 6,452 7 10, 11 28 3,050 2,442 (385) 1,436 (3,172) 656 (247) 2,449 3,007 (16) (309) (2,607) 295 (324) 2,712 2,142 (73) 959 (3,514) 391 (296) 8,773 (804) (686) 455 Cash flow before change in working capital 13,425 11,017 Change in working capital: (Increase)/decrease in trade receivables and other receivables (Increase)/decrease in inventories Increase/(decrease) in trade payables and other liabilities (1,110) (651) 1,199 (702) (617) 289 Cash flow from operating activities 12,863 9,987 7,738 Investments: Acquisition of subsidiaries and business units Sale of intangible assets and long-term financial assets Purchase of intangible assets and long-term financial assets Sale of property, plant and equipment Purchase of property, plant and equipment Net change in marketable securities (maturity exceeding three months) Dividend received Net cash used in investing activities Financing: Repayment of long-term debt Purchase of treasury shares Sale of treasury shares Dividends paid Cash flow from financing activities Net cash flow Unrealised gain/(loss) on exchange rates and marketable securities included in cash and cash equivalents Net change in cash and cash equivalents Cash and cash equivalents at the beginning of the year Cash and cash equivalents at the end of the year Supplemental information: Cash and cash equivalents at the end of the year Bonds with original term to maturity exceeding three months Undrawn committed credit facilities 29 15 16 30 30 17 26 – – (264) 18 (1,772) 466 170 (1,382) (153) (4,717) 295 (2,795) (7,370) (59) – (118) 40 (2,308) (541) 1,470 (1,516) (18) (4,835) 241 (2,221) (6,833) 4,111 1,638 (2) (6) 4,109 4,617 8,726 8,726 997 7,451 1,632 2,985 4,617 4,617 1,486 7,457 – 175 (419) 111 (2,898) 514 – (2,517) (23) (3,000) 210 (1,945) (4,758) 463 39 502 2,483 2,985 2,985 1,001 7,456 Financial resources at the end of the year 17,174 13,560 11,442 Cash flow from operating activities + Net cash used in investing activities – Net change in marketable securities (maturity exceeding three months) Free cash flow 12,863 (1,382) 466 11,015 9,987 (1,516) (541) 9,012 7,738 (2,517) 514 4,707 54 Novo Nordisk Annual Report 2008 Consolidated financial statements Consolidated statement of changes in equity Share capital Treasury shares Retained earnings Other reserves Total Exchange rate adjust- ments Deferred gain/(loss) on cash flow hedges Other adjust- ments 647 (26) 30,661 209 678 13 32,182 9,645 (615) (940) (473) 8 18 – (465) (1,537) 9,645 (465) (1,537) (9) 39 (45) 55 40 40 331 (4,701) 292 (2,795) 9,645 (615) (940) (473) (9) 39 (45) 81 (1,962) 7,683 331 (4,717) 295 – (2,795) – – (13) – – (16) 3 13 634 (26) 33,433 (256) (859) 53 32,979 DKK million 2008 Balance at the beginning of the year Net profit for the year Deferred (gain)/loss on cash flow hedges at the beginning of the year recognised as financial income/expenses for the year Fair value adjustment on financial instruments Exchange rate adjustment of investments in subsidiaries Fair value adjustments on financial assets available for sale Novo Nordisk share of equity recognised by associated companies Other adjustments Tax adjustments Net income recognised directly in equity for the year Total recognised income and expense for the year Share-based payment Purchase of treasury shares Sale of treasury shares Reduction of the B share capital Dividends Balance at the end of the year At the end of the year proposed dividends (not yet declared) of DKK 3,650 million (DKK 6.00 per share) are included in Retained earnings. No dividend is declared on treasury shares. DKK million 2007 Balance at the beginning of the year Net profit for the year Deferred (gain)/loss on cash flow hedges at the beginning of the year recognised as financial income/expenses for the year Fair value adjustment on financial instruments Exchange rate adjustment of investments in subsidiaries Fair value adjustments on financial assets available for sale Novo Nordisk share of equity recognised by associated companies Other adjustments Tax adjustments Net income recognised directly in equity for the year Total recognised income and expense for the year Share-based payment Purchase of treasury shares Sale of treasury shares Reduction of the B share capital Dividends Balance at the end of the year Share capital Treasury shares Retained earnings Other reserves *) Total Exchange rate adjust- ments Deferred gain/(loss) on cash flow hedges Other adjust- ments 674 (39) 28,810 156 419 102 30,122 8,522 – – (27) – – (16) 2 27 – 8,522 130 (4,819) 239 (2,221) (363) 634 (12) 259 259 53 0 53 53 12 (41) 21 (81) (89) (89) 8,522 (363) 634 53 12 (41) 21 (93) 223 8,745 130 (4,835) 241 – (2,221) 647 (26) 30,661 209 678 13 32,182 *) In 2007 adjustments have been made on other reserves regarding the split of tax adjustments. At the end of the year proposed dividends (declared) of DKK 2,795 million (DKK 4.50 per share) are included in Retained earnings. No dividend is declared on treasury shares. Novo Nordisk Annual Report 2008 55 Consolidated financial statements Notes – Consolidated financial statements 1 Summary of significant accounting policies The Consolidated financial statements are prepared in accordance with Inter - national Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and with the International Financial Reporting Standards as adopted by the EU. The Consolidated financial state- ments are prepared in accordance with the historical cost convention, as modified by the revaluation of available-for-sale financial assets, financial assets and financial liabilities (derivative financial instruments) at fair value through profit or loss. The Financial statements of the Parent company, Novo Nordisk A/S, are prepared in accordance with The Danish Financial Statements Act. These are presented on pages 105 to 112 and the accounting policies are set out on page 108. Further, the Annual Report is prepared in accordance with additional Danish disclosure requirements for annual reports for listed companies. Effects of new accounting pronouncements In 2008, Novo Nordisk has adopted the following new or revised standards and interpretations endorsed by EU effective for the accounting period beginning on 1 January 2008. • Interpretation guideline to IAS 19, IFRIC 14 – ‘The limit on a defined benefit asset, minimum funding requirement and their interaction’. IFRIC 14 provides guidance on assessing the limit in IAS 19 ‘Employee benefits’ on the amount of the surplus that can be recognised as an asset. It also explains how the pension asset or liability may be affected by a statutory or con tractual minimum funding requirement. The guideline has no impact on the Group’s Financial Statements. The following interpretation of published standards is mandatory for accounting periods beginning on 1 January 2008 but is not relevant to the Group’s operations: • IFRIC 12, ‘Service concession arrangements’ Standards early adopted by the Group The following standard with effective date of 1 January 2009 has been adopted by the group. • IFRS 8 ‘Operating segments’ was early adopted in 2008. The impact is limited as the reportable segments – diabetes care and biopharmaceuticals – are unchanged as they are consistent with the internal reporting provided to management. Standards not adopted by the Group The following standards and interpretations relevant to Novo Nordisk have been issued and endorsed by EU as per 31 December 2008 and are mandatory for the Group’s accounting periods beginning on or after 1 January 2009. These have not yet been adopted by Novo Nordisk: • IAS 1 (Revised), ‘Presentation of financial statements’ (effective from 1 January 2009). The revised standard will prohibit the presentation of items of income and expenses (that is, ‘non-owner changes in equity’) in the statement of changes in equity, requiring ‘non-owner changes in equity’ to be presented separately from owner changes in equity (com - prehensive income statement). • IAS 23 (Amendment) ‘Borrowing costs’ (effective from 1 January 2009). The option of immediately expensing borrowing costs of a qualifying asset will be removed. Given the present capital structure of the Group the impact is expected to be limited. • IFRS 2 (Amendment), ‘Share-based payment’ (effective from 1 January 2009). The amended standard deals with vesting conditions and cancellations. All cancellations, whether by the entity or by other parties, should receive the same accounting treatment. It is not expected to have a material impact on the Group’s financial statements. Standards not endorsed by EU • IAS 27 (Revised), ‘Consolidated and separate financial statements’, (effective from 1 July 2009). The revised standard requires the effects of all transactions with non-controlling interests to be recorded in equity if there is no change in control and these transactions will no longer result in good- will or gains and losses. It is not expected to have a material impact on the Group’s financial statements. 56 Novo Nordisk Annual Report 2008 • IFRS 3 (Revised), ‘Business combinations’ (effective from 1 July 2009). The revised standard continues to apply the acquisition method to business combinations, with some significant changes. For example, all payments to purchase a business are to be recorded at fair value at the acquisition date, with contingent payments classified as debt subsequently remeasured through the Income statement. All acquisition-related costs should be expensed. • IFRS 5 (Amendment), ‘Non-current assets held-for-sale and discontinued operations’ (and consequential amendment to IFRS 1, ‘First-time adoption’) (effective from 1 July 2009). The amendment clarifies that all of a sub- sidiary’s assets and liabilities are classified as held for sale if a partial disposal sale plan results in loss of control. • IAS 28 (Amendment), ‘Investments in associates’ (and consequential amendments to IAS 32, ‘Financial Instruments: Disclosure and Presentation’, and IFRS 7, ‘Financial instruments: Disclosures’) (effective from 1 January 2009). An investment in associate is treated as a single asset for the purposes of impairment testing. It is not expected to have material impact on the Group’s financial statements. • IAS 36 (Amendment), ‘Impairment of assets’ (effective from 1 January 2009). Where fair value less costs to sell is calculated on the basis of dis- counted cash flows, disclosures equivalent to those for value-in-use calculation should be made. • IAS 38 (Amendment), ‘Intangible assets’ (effective from 1 January 2009). A prepayment may only be recognised in the event that payment has been made in advance of obtaining right of access to goods or receipt of services. It is not expected to have a material impact on the Group’s financial state- ments. • IAS 19 (Amendment), ‘Employee benefits’ (effective from 1 January 2009). The amendment clarifies the handling of plan amendment. The distinction between short-term and long-term employee benefits will be based on whether benefits are due to be settled within or after 12 months of employee service being rendered. It is not expected to have a material impact on the Group’s financial statements. • There are a number of minor amendments to IFRS 7, ‘Financial instruments: Disclosures’, IAS 1 (Amendment), ‘Presentation of financial statements’, IAS 8, ‘Accounting policies, changes in accounting estimates and errors’, IAS 10, ‘Events after the reporting period’, IAS 18, ‘Revenue’, IAS 34, ‘Interim financial reporting’ and IAS 39 (Amendment), ‘Financial instru- ments: Recognition and measurement’. These amendments are not expected to have an impact on the Group’s financial statements. • IFRIC 16, ‘Hedges of a net investment in a foreign operation’ (effective from 1 January 2009). IFRIC 16 clarifies the accounting treatment in respect of net investment hedging. This includes the fact that net investment hedging relates to differences in functional currency not presentation currency, and hedging instruments may be held anywhere in the Group. The requirements of IAS 21, ‘The effects of changes in foreign exchange rates’, do apply to the hedged item. It is not expected to have a material impact on the Group’s financial statements. The following interpretations and amendments to existing standards have been published and are mandatory for the Group’s accounting periods beginning on or after 1 January 2009 or later periods but are not relevant for the Group’s operations: • IFRS 1 (Amendment) ‘First time adoption of IFRS’, IAS 27 ‘Consolidated and separate financial statements’, IAS 16 (Amendment), ‘Property, plant and equipment’ (and consequential amendment to IAS 7, ‘Statement of cash flows’), IAS 27 (Amendment), ‘Consolidated and separate financial state- ments’, IAS 28 (Amendment), ‘Investments in associates’ (and consequential amendments to IAS 32, ‘Financial Instruments: Disclosure and Presentation’ and IFRS 7, ‘Financial instruments: Disclosures’), IAS 29 (Amendment), ‘Finan cial reporting in hyperinflationary economies’, IAS 31 (Amendment), ‘Interests in joint ventures’ (and consequential amendments to IAS 32 and IFRS 7), IAS 32 (Amendment), ‘Financial instruments: Disclosure and Presentation’, IAS 1 (Amend ment), ‘Presentation of financial statements’ – ‘Puttable financial instruments and obligations arising on liquidation’, IAS 37, ‘Provisions, contingent liabilities and contingent asset’, IAS 38 (Amend ment), ‘Intangible assets’, IAS 40 (Amendment), ‘Investment pro - perty’ (and consequential amendments to IAS 16), IAS 41 (Amendment), Consolidated financial statements Notes – Consolidated financial statements 1 Summary of significant accounting policies (continued) ‘Agriculture’, IAS 20 (Amendment), ‘Accounting for government grants and disclosure of government assistance’, IFRIC 13, ‘Customer loyalty programmes’ and IFRIC 15, ‘Agree ments for construction of real estates’. Principles of consolidation The Consolidated Financial Statements include the financial statements of Novo Nordisk A/S (the Parent company) and all the companies in which Novo Nordisk A/S directly or indirectly owns more than 50% of the voting rights or in some other way has a controlling influence (subsidiaries). Novo Nordisk A/S and these companies are referred to as the Group. Companies that are not subsidiaries, but in which the Group holds 20% to 50% of the voting rights or in some other way has a significant influence on the operational and financial management, are treated as associated com- panies. sale is conditional on future events, the amount is recorded as income at the occurrence of such future events. Revenue is measured at the fair value of the consideration received or receivable. Research and development Due to the long development period and significant uncertainties relating to the development of new products, including risks regarding clinical trials and regulatory approval, it is concluded that the Group’s internal development costs in general do not meet the capitalisation criteria in IAS 38 ‘Intangible Assets’. Consequently, the technical feasibility criteria of IAS 38 are not con- sidered fulfilled before regulatory approval is obtained. Therefore, all internal research and development costs are expensed in the Income statement as incurred. The Consolidated financial statements are based on the Financial statements of the Parent company and of the subsidiaries and are prepared by combining items of a uniform nature and eliminating intercompany transactions, share- holdings, balances and unrealised intercompany profits and losses. The Consolidated financial statements are based on financial statements prepared by applying the Group’s accounting policies. For acquired in-process research and development projects the effect of probability is reflected in the cost of the asset and the probability recognition criteria are therefore always considered satisfied. As the cost of acquired in-process research and development projects can often be measured reliably, these projects fulfil the criteria for capitalisation. Please refer to the section ‘Intangible assets’ regarding the accounting treatment of intangible assets. The purchase method of accounting is used to account for the acquisition of businesses by the Group. The cost of an acquisition is measured as the fair value of the assets given and liabilities incurred or assumed at the date of exchange, plus costs directly attributable to the acquisition. Identifiable assets acquired, liabilities and contingent liabilities assumed in a business combina- tion are measured initially at their fair values at the acquisition date, irrespective of the extent of any minority interest. The excess of the cost of acquisition over the fair value of the Group’s share of the identifiable net assets acquired is recorded as goodwill. Acquired and divested companies are included in the Income statement during the period of Novo Nordisk’s ownership. Comparative figures are not adjusted for disposed or acquired companies. CRITICAL ACCOUNTING POLICIES Property, plant and equipment used for research and development purposes are capitalised and depreciated over their estimated useful lives. Derivative financial instruments The Group uses forward exchange contracts, currency options, interest rate swaps and currency swaps to hedge forecasted transactions, assets and liabilities, and net investments in foreign subsidiaries in foreign currencies. Novo Nordisk applies hedge accounting under the specific rules of IAS 39 ‘Financial instruments’ to forward exchange contracts and currency swaps. Upon initiation of the contract, the Group designates each derivative financial contract that qualifies for hedge accounting as a hedge of a specific hedged transaction: either i) a recognised asset or liability (fair value hedge), ii) a fore- casted financial transaction or firm commitment (cash flow hedge), or iii) a hedge of a net investment in a foreign entity. Novo Nordisk’s management considers the following to be the most critical accounting policies for the Group. Sales and revenue recognition Sales represent the fair value of the sale of goods excluding value added tax and after deduction of provisions for returned products, rebates, trade discounts and allowances. All contracts are initially recognised at fair value and subsequently re- measured at their fair values at the balance sheet date. The value adjustments on forward exchange contracts designated as hedges of forecasted trans - actions are recognised directly in equity, given hedge effectiveness. The cumu- lative value adjustment of these contracts is removed from equity and in cluded in the Income statement under Financial income or Financial expenses when the hedged transaction is recognised in the Income statement. Provisions and accruals for rebates to customers are provided for in the period the related sales are recorded. Historical data are readily available and reliable and are used for estimating the amount of the reduction in sales. Novo Nordisk applies the hedge accounting requirements to interest rate swaps hedging forecasted transactions. Consequently, the fair value effect of interest rate adjustments on these contracts is recognised in equity. Revenue is recognised when it is realised or realisable and earned. Revenues are considered to have been earned when Novo Nordisk has substantially accomplished what it must do to be entitled to the revenues. Revenue from the sale of goods is recognised when all the following specific conditions have been satisfied: • Novo Nordisk has transferred to the buyer the significant risk and rewards of ownership of the goods • Novo Nordisk retains neither continuing managerial involvement to the degree usually associated with ownership nor effective control over the goods sold • The amount of revenue can be measured reliably • It is probable that the economic benefits associated with the transaction will flow to Novo Nordisk; and • The costs incurred or to be incurred in respect of the transaction can be measured reliably Currency swaps used to hedge net investments in subsidiaries are measured at fair value based on the difference between the swap exchange rate and the exchange rate at the balance sheet date. The value adjustment is recognised in equity. Currency options are initially recognised at cost and subsequently re- measured at their fair values at the balance sheet date. While providing effective economic hedges under the Group’s risk management policy, the current use of currency options does not meet the detailed requirements of IAS 39 for allowing hedge accounting. Currency options are therefore recognised directly in the Income statement under Financial income or Financial expenses. Forward exchange contracts and currency swaps hedging recognised assets or liabilities in foreign currencies are measured at fair value at the balance sheet date. Value adjustments are recognised in the Income statement under Financial income or Financial expenses, along with any value adjustments of the hedged asset or liability that is attributable to the hedged risk. These conditions are usually met by the time the products are delivered to the customers. Licence fees are recognised on an accrual basis in accordance with the terms and substance of the relevant agreement. All fair values are based on marked-to-market prices or standard pricing models. As a principal rule, sale of intellectual property is recorded as income at the time of the sale. Where the Group assumes an obligation in connection with a sale of intellectual property, the income is recognised in accordance with the term of the obligation. On the sale of intellectual property where the final The accumulated net fair value of derivative financial instruments is presented as ‘Marketable securities and financial derivatives’, if positive, or ‘Short-term debt and financial derivatives’, if negative. Novo Nordisk Annual Report 2008 57 Consolidated financial statements Notes – Consolidated financial statements 1 Summary of significant accounting policies (continued) Provisions Provisions, including tax and legal cases, are recognised where a legal or constructive obligation has been incurred as a result of past events and it is probable that it will lead to an outflow of resources that can be reliably estimated. In this connection Novo Nordisk makes the estimate based upon an evaluation of the individual most likely outcome of the cases. In the case where a reliable estimate cannot be made, these are disclosed as contingent liabilities. OTHER ACCOUNTING POLICIES Segment reporting Operating segments are reported in a manner consistent with the internal reporting provided to executive management, who is responsible for business strategies, allocating resources and addressing performance of the operating segments. Translation of foreign currencies Functional and presentation currency Items included in the financial statements of each of the Group’s entities are measured using the currency of the primary economic environment in which the entity operates (functional currency). The Consolidated financial state- ments are presented in Danish kroner (DKK), which is the functional and presentation currency of the Parent company. Translation of transactions and balances Foreign currency transactions are translated into the functional currency using the exchange rates ruling at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in the Income statement, except when deferred in equity as qualifying cash flow hedges and qualifying net investment hedges. Translation differences on non-monetary items, such as financial assets classified as available-for-sale, are included in the fair value reserve in equity. Translation of Group companies Financial statements of foreign subsidiaries are translated into Danish kroner at exchange rates ruling at the balance sheet date for assets and liabilities and at average exchange rates for Income statement items. All exchange rate adjustments are recognised in the Income statement with the exception of exchange gains and losses arising from: • The translation of foreign subsidiaries’ net assets at the beginning of the year translated at the exchange rates at the balance sheet date • The translation of foreign subsidiaries’ income statements using average exchange rates, whereas balance sheets are translated using the exchange rates ruling at the balance sheet date • The translation of long-term intercompany receivables that are considered to be an addition to net investments in subsidiaries • The translation of investments in associated companies Other intangible assets Patents and licences, that include acquired patents and licences to in-process research and development projects, are carried at historical cost less accumu- lated amortisation and any impairment loss. Internal development of software and the costs related in connection with major IT projects for internal use are capitalised under Other intangible assets. Amortisation is provided under the straight-line method over the estimated useful life of the asset as follows: • IT projects: 3–10 years For the patents and in-process research and development projects the amortisation commence in the year in which the rights first generate sales. Property, plant and equipment Property, plant and equipment are measured at historical cost less accumu - lated depreciation and any impairment loss. The cost of self-constructed assets includes costs directly attributable to the construction of the assets. Interest on loans financing construction of major investments is recognised as an expense in the period in which it is incurred. Subsequent cost is included in the asset’s carrying amount or recognised as a separate asset, as appropriate, only when it is probable that future economic benefits associated with the item will flow to the Group and the cost of the item can be measured reliably. Land is not depreciated. Depreciation is provided under the straight-line method over the estimated useful lives of the assets as follows: • Buildings: 12– 50 years • Plant and machinery: 5 –16 years • Other equipment: 3 –16 years The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at each balance sheet date. An asset’s carrying amount is written down to its recoverable amount if the asset’s carrying amount is higher than its estimated recoverable amount. Leases Leases of assets whereby the Group assumes substantially all the risks and rewards of ownership are capitalised as finance leases under Property, plant and equipment and depreciated over the estimated useful lives of the assets, according to the periods listed above. The corresponding finance lease liabilities are included in liabilities. Operating lease costs are charged to the Income statement on a straight-line basis over the period of the lease. Investments in associated companies Investments in associated companies are accounted for under the equity method of accounting (ie at the respective share of the associated companies’ net asset value applying Group accounting policies). The above exchange gains and losses are recognised in Other reserves under equity. Goodwill relating to associated companies is recorded under Investments in associated companies. Licence fees and other operating income (net) Licence fees and other operating income (net) comprise licence fees and income (net) of a secondary nature in relation to the main activities of the Group. The item also includes non-recurring income items (net) in respect of sale of intellectual property. Intangible assets Goodwill Goodwill represents any cost in excess of identifiable net assets, measured at fair value, in the acquired company. Goodwill recorded under Intangible assets is related to subsidiaries. Goodwill is measured at historical cost less accumulated impairment losses. Gains and losses on the disposal of an entity include the carrying amount of goodwill relating to the entity sold. Goodwill is allocated to cash-generating units for the purpose of impairment testing. Impairment of assets Assets that have an indefinite useful life, for example brands or goodwill, are tested annually for impairment. The Group assesses the carrying amount of intangible assets and long-lived assets annually, or more frequently if events or changes in circumstances indicate that such carrying amounts may not be recoverable. Factors con sidered material by the Group and that could trigger an impairment test include the following: • Significant underperformance relative to historical or projected future results • Significant changes in the manner of the Group’s use of the acquired assets or the strategy for its overall business • Significant negative industry or economic trends When it is determined that the carrying amount of intangible assets, long- lived assets or goodwill may not be recoverable based upon the existence of one or more of the above indicators of impairment, any impairment is measured based on discounted projected cash flows. 58 Novo Nordisk Annual Report 2008 Consolidated financial statements Notes – Consolidated financial statements 1 Summary of significant accounting policies (continued) This impairment test is based upon management’s projections and anticipated future cash flows. The most significant variables in determining cash flows are discount rates, terminal values, the number of years on which to base the cash flow projections, as well as the assumptions and estimates used to deter- mine the cash inflows and outflows. Management determines the discount rates to be used based on the risk inherent in the related activity’s current business model and industry comparisons. Terminal values are based on the expected life of products, forecasted lifecycle and forecasted cash flows over that period and the useful lives of the underlying assets. While the assumptions are believed to be appropriate, the amounts estimated could differ materially from what actually occurs in the future. These discounted cash flows are prepared at cash-generating-unit level. The cash- generating-units are the smallest group of identifiable assets that generates cash inflows from continuing use which are largely independent of the cash inflows from other assets or groups of assets. Financial assets The Group classifies its investments in the following categories: Financial assets at fair value through profit or loss (financial derivatives), Loans and receivables and Available-for-sale financial assets. The classification depends on the purpose for which the investments were acquired. Management determines the classification of its investments on initial recognition and re- evaluates this designation at every reporting date to the extent that such a designation is permitted and required. Financial assets at fair value through profit or loss Financial derivatives used for hedging purposes are classified under financial assets at fair value through profit or loss even though financial derivatives used for hedging purposes, which do not qualify for hedge accounting, are regulated on equity. Assets in this category are classified as current assets. Loans and receivables Loans and receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. Loans and receivables are included in Trade receivables and Other receivables in the Balance sheet. Trade receivables and Other receivables are stated at amortised cost less allowances for doubtful trade receivables. The allowances are based on an individual assessment of each receivable. Available-for-sale financial assets Available-for-sale financial assets are non-derivatives that are either designated in this category or not classified in any of the other categories. They are included in Other financial assets unless management intends to dispose of the investment within 12 months of the balance sheet date. Marketable securities under current assets are classified as available-for-sale financial assets. Recognition and measurement Purchases and sales of investments are recognised on the settlement date. Investments are initially recognised at fair value plus transaction costs for all financial assets not classified as fair value through profit or loss. Currency options, available-for-sale financial assets and financial assets at fair value through profit or loss are subsequently carried at fair value. Loans and receivables are carried at amortised cost using the effective interest method. Unrealised gains and losses arising from changes in the fair value of financial assets classified as available-for-sale are recognised in equity. When financial assets classified as available-for-sale are sold or impaired, the accumulated fair value adjustments are included in the Income statement as gains and losses from available-for-sale financial assets. The fair values of quoted investments are based on current bid prices. Finan - cial assets for which no active market exists are carried at cost if no reliable valuation model can be applied (unlisted shares). The Group assesses at each balance sheet date whether there is objective evidence that a financial asset or a group of financial assets have been impaired. If any such evidence exists for available-for-sale financial assets, the cumulative loss is removed from equity and recognised in the Income state- ment. Impairment losses recognised in the Income statement on equity instru- ments are not reversed through the Income statement. Investments are derecognised when the rights to receive cash flows from the investments have expired or have been transferred and the Group has trans- ferred substantially all risks and rewards of ownership. Inventories Raw materials and consumables are measured at cost assigned by using the first-in, first-out method. Work in progress and finished goods are stated at cost assigned by using the first-in, first-out method. Cost comprises direct production costs such as raw materials, consumables, energy and labour, and production overheads such as employee costs, depreciation, maintenance etc. The production overheads are measured based on a standard cost method which is reviewed regularly in order to ensure relevant measures of utilisation, production lead time etc. If the expected sales price less completion costs and costs to execute sales (net realisable value) is lower than the carrying amount, a write-down is recognised for the amount by which the carrying amount exceeds its net realisable value. Tax Income taxes in the Income statement include tax payable for the year with addition of the change in deferred tax for the year. Deferred income taxes arise from temporary differences between the accounting and tax balance sheets of the individual consolidated companies and from realisable tax-loss carry-forwards, using the liability method. The tax value of tax-loss carry-forwards is included in deferred tax assets to the extent that the tax losses and other tax assets are expected to be utilised in the future taxable income. The deferred income taxes are measured according to current tax rules and at the tax rates expected to be in force on the elimination of the temporary differences. Unremitted earnings are retained by subsidiary companies for reinvestment. No provision is made for income taxes that would be payable upon the distribution of such earnings. If the earnings were remitted, an immaterial income tax charge would result, based on the tax statutes currently in effect. No deferred tax is calculated on differences associated with investments in subsidiaries, branches and associates as the differences by nature are permanent differences. However, deferred tax is calculated if the differences are tax deductible. Employee benefits Wages, salaries, social security contributions, paid annual leave and sick leave, bonuses and non-monetary benefits are accrued in the year in which the associated services are rendered by employees of the Group. Where the Group provides long-term employee benefits, the costs are accrued to match the rendering of the services by the employees concerned. Pensions The Group operates a number of defined contribution plans throughout the world. In a few countries the group still operates defined benefit plans. The costs for the year for defined benefit plans are determined using the projected unit credit method. This reflects services rendered by employees to the dates of valuation and is based on actuarial assumptions primarily regarding dis- count rates used in determining the present value of benefits, projected rates of remuneration growth and long-term expected rates of return for plan assets. Discount rates are based on the market yields of high-rated corporate bonds in the country concerned. Actuarial gains and losses are recognised as income or expense when the net cumulative unrecognised actuarial gains and losses for each individual plan at the end of the previous reporting period exceeded 10% of the higher of the defined benefit obligation and the fair value of plan assets at that date. These gains or losses are recognised over the expected average remaining working lives of the employees participating in the plans. Past service costs are allocated over the average period until the benefits be- come vested. Pension assets and liabilities in different defined benefit schemes are not off- set unless the Group has a legally enforceable right to use the surplus in one plan to settle obligations in the other plan. Pension assets are only recognised to the extent that the Group is able to derive future economic benefits in the way of refunds from the plan or reductions of future contributions. Novo Nordisk Annual Report 2008 59 Consolidated financial statements Notes – Consolidated financial statements 1 Summary of significant accounting policies (continued) 3 Critical accounting estimates and judgements The Group’s contributions to the defined contribution plans are charged to the Income statement in the year to which they relate. Share-based compensation The Group operates equity-settled, share-based compensation plans. The fair value of the employee services received in exchange for the grant of the options or shares is recognised as an expense and allocated over the vesting period. The total amount to be expensed over the vesting period is determined by reference to the fair value of the options or shares granted, excluding the impact of any non-market vesting conditions. The fair value is fixed at grant date. Non-market vesting conditions are included in assumptions about the number of options or shares that are expected to become exercisable. At each balance sheet date, the Group revises its estimates of the number of options or shares that are expected to become exercisable. Novo Nordisk recognises the impact of the revision of the original estimates, if any, in the Income state- ment and a corresponding adjustment to equity over the remaining vesting period. Adjustments relating to prior years are included in the Income state- ment in the year of adjustment. Liabilities Generally, liabilities are stated at amortised cost unless specifically mentioned otherwise. Equity Treasury shares Treasury shares are deducted from the share capital at their nominal value of DKK 1 per share. Differences between this amount and the amount paid for acquiring, or received for disposing of, treasury shares are deducted from retained earnings. Other reserves Other reserves consist of exchange rate adjustments, cash flow hedging reserve and other adjustments. Dividends Dividends are recognised as a liability in the period in which they are declared at the Annual General Meeting. Consolidated statement of cash flows and financial resources The Consolidated statement of cash flows and financial resources is presented in accordance with the indirect method commencing with net profit. The statement shows cash flows for the year, the net change in cash and cash equivalents for the year, and cash and cash equivalents at the beginning and the end of the year. Cash and cash equivalents consist of cash and marketable securities, with original maturity of less than three months, less short-term bank loans. Financial resources consist of cash and cash equivalents, bonds with original term to maturity exceeding three months, and undrawn committed credit facilities expiring after more than one year. 2 Changes in the scope of consolidation In 2008, no changes in the scope of consolidation occurred. In 2007, the Novo Nordisk subsidiary NNE A/S (NNE Pharmaplan A/S) com - pleted the acquisition of the engineering activities in Pharmaplan GmbH from the German medical group Fresenius. The cost of the business com bination was DKK 59 million. The purchase price was paid in cash. The net assets were included in the consolidation as from 1 April 2007. In 2006, no changes in the scope of consolidation occurred. The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assump- tions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date(s) of the financial statements and the reported amounts of revenues and expenses during the reporting period(s). Management bases its estimates on historical experience and various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgements about the reported carrying amounts of assets and liabilities and the reported amounts of revenues and expenses that may not be readily apparent from other sources. Actual results could differ from those estimates. Novo Nordisk believes the following are the critical accounting estimates and judgements used in the preparation of its consolidated financial statements. Non-recurring costs related to discontinuation of all pulmonary diabetes projects Towards the end of 2007, Novo Nordisk conducted a detailed analysis of the future prospects for inhaled insulin and a review of the medical and commer- cial potential of the AERx ® iDMS inhaled insulin system (AERx ®). This analysis resulted in a non-recurring impairment cost regarding intangible assets and manufacturing activities related to the AERx ® system and cost of discontinuing all clinical development in the amount of DKK 1,325 million, which were recorded and negatively impacted operating profit in 2007. In April 2008, Novo Nordisk also decided to discontinue the remaining part of its pulmonary activities. As a result of these decisions an additional cost of DKK 325 million was included in Research and development costs in the 2008 Annual Report. In 2008 and 2007, Novo Nordisk recorded the following charges related to the impairment of pulmonary diabetes projects. DKK million 2008 2007 Impairment of intangible assets Severance pay and other employee related costs Impairment of tangible assets Commitments regarding clinical trials Leasing and investment commitments Other cost related to closure of pulmonary diabetes projects Total costs – 155 53 – 42 75 325 117 – 753 326 129 – 1,325 These charges were included in Research and development costs. In addition, a cost of DKK 52 million, related to the AERx ® discontinuation, was included as financial expense in 2007. Sales rebate accruals and provisions Sales rebate accruals and provisions are established in the same period as the related sales. The sales rebate accruals and provisions are recorded as a reduction in sales and are included in Other provisions and Other liabilities. The accruals and provisions are based upon historical rebate payments. They are calculated based upon a percentage of sales for each product as defined by the contracts with the various customer groups. Factors that complicate the rebate calculations are: • Identification of the products which have been sold subject to a rebate • The customer or government price terms which apply • The estimated time lag between sale and payment of a rebate The US market has the most complex arrangements for rebates, discounts and allowances. 60 Novo Nordisk Annual Report 2008 Consolidated financial statements Notes – Consolidated financial statements 3 Critical accounting estimates and judgements (continued) Significant sales rebate and discount amount are rebates from sales covered by Medicaid and Medicare, the US public healthcare insurance system. Provisions for Medicaid and Medicare rebates have been calculated using a combination of historical experience, product and population growth, price increases, the impact of contracting strategies and specific terms in the individual agreements. For Medicaid, the calculation of rebates involves inter- pretation of relevant regulations, which are subject to challenge or change in interpretative guidance by government authorities. Although accruals are made for Medicaid and Medicare rebates at the time sales are recorded, the Medicare and Medicaid rebates related to the specific sale will typically be invoiced to Novo Nordisk up to six months later. Due to the time lag, in any particular period the rebate adjustments to sales may incorporate revisions of accruals for prior periods. Customer rebates are offered to a number of managed healthcare plans. These rebate programmes provide that the customer receives a rebate after attaining certain performance parameters relating to product purchases, formulary status and pre-established market share milestones relative to com- petitors. Since rebates are contractually agreed upon, rebates are estimated based on the specific terms in each agreement, historical experience, anti - cipated channel mix, product growth rates and market share information. Novo Nordisk considers the sales performance of products subject to managed healthcare rebates and other contract discounts and adjusts the provision periodically to reflect actual experience. Wholesaler charge-backs relate to contractual arrangements Novo Nordisk has with indirect customers, mainly in the US, to sell products at prices that are lower than the list price charged to wholesalers. A wholesaler charge- back represents the difference between the invoice price to the wholesaler and the indirect customer’s contract price. Provisions are calculated for estimated charge-back using a combination of factors such as historical experience, current wholesaler inventory levels, contract terms and the value of claims received yet not processed. Wholesaler charge-backs are generally settled within one to three months of incurring the liability. Novo Nordisk believes that the accruals and provisions established for sales rebates are reasonable and appropriate based on current facts and circum- stances. However, the actual amount of rebates and discounts may differ from the amounts estimated by management. A reconciliation of gross sales to net sales for North America (includes the US and Canada) is as follows: DKK million Gross sales Gross-to-net sales adjustments: Medicaid and Medicare rebates Managed healthcare rebates Wholesaler charge-backs Cash discounts Sales returns Other rebates and allowances 2008 2007 2006 22,639 20,109 17,196 (1,672) (1,543) (2,949) (433) (512) (376) (1,279) (1,333) (2,594) (381) (432) (344) (1,186) (1,073) (2,074) (310) (116) (157) Total gross-to-net sales adjustments (7,485) (6,363) (4,916) Net sales 15,154 13,746 12,280 The carrying amount of sales rebate accruals and provisions is DKK 2,400 million at 31 December 2008. Please refer to notes 5 and 25 for further infor- mation on sales accruals and provisions. Indirect production costs (IPCs) Work in progress and finished goods are stated at cost assigned by using the first-in, first-out method. Cost comprises direct production costs such as raw materials, consumables, energy and labour, as well as IPCs such as employee costs, depreciation, maintenance etc. IPCs are measured based on a standard cost method which is reviewed regularly in order to ensure relevant measures of utilisation, production lead time and other relevant factors. Changes in the parameters for calculation of IPCs, including utilisation levels, production lead time etc could have an im- pact on the gross margin and the overall valuation of inventories. The carrying amount of IPCs is DKK 4,633 million at 31 December 2008. Please refer to note 18 for further information. Allowances for doubtful trade receivables Trade receivables are stated at amortised cost less allowances for potential losses on doubtful trade receivables. Novo Nordisk maintains allowances for doubtful trade receivables for estimated losses resulting from the subsequent inability of the customers to make required payments. If the financial conditions of the customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances may be required in future periods. Management specifi- cally analyses trade receivables and analyses historical bad debt, customer concentrations, customer creditworthiness, current economic trends and changes in the customer payment terms when evaluating the adequacy of the allowance for doubtful trade receivables. The uncertainty connected with the allowance for doubtful trade receivables is considered limited. The carrying amount of allowances for doubtful trade receivables is DKK 602 million at 31 December 2008. Please refer to note 19 for further information. Income taxes Management judgement is required in determining the Group’s provision for deferred income tax assets and liabilities. Novo Nordisk recognises deferred income tax assets if it is probable that sufficient taxable income will be avail- able in the future against which the temporary differences and unused tax losses can be utilised. Management has considered future taxable income in assessing whether deferred income tax assets should be recognised. The carrying amount of deferred income tax assets and deferred income tax liabilities is DKK 1,696 million and DKK 2,404 million respectively at 31 December 2008. Please refer to note 23 for further information. Provisions and contingencies As part of normal business Novo Nordisk issues credit notes for expired goods. Consequently a provision for future returns is made, based on historical statisti cal product returns. Revenue recognition for new product launches is based on specific facts and circumstances for the specific products, including estimated demand and acceptance rates from well-established products with similar market characteri stics. In recent years the products launched by Novo Nordisk have been comparable with either other products already on the market or pro - ducts in therapy areas well known to Novo Nordisk, and therefore uncertain- ties surrounding products launched have been limited. The carrying amount of provision for returned products is DKK 594 million at 31 December 2008. Please refer to note 25 for further information. Management of the Group makes judgements about provisions and con - tingencies, including the probability of pending and potential future litigation outcomes that in nature are dependent on future events that are inherently uncertain. In making its determinations of likely outcomes of litigation etc, management considers the evaluation of external counsel knowledgeable about each matter, as well as known outcomes in case law. Provisions for pending litigations are recognised under Other provisions. Please refer to notes 25 and 36 for a description of significant litigations pending. Novo Nordisk Annual Report 2008 61 Consolidated financial statements Notes – Consolidated financial statements 4 Segment information Business segments For management reporting purposes, the Group operates in two global business segments based on different therapies: Diabetes care: The business segment includes discovery, development, manufacturing and marketing of products within the areas of insulin, GLP-1 and related delivery systems as well as oral antidiabetic products (OAD). Biopharmaceuticals: The business segment includes discovery, development, manufacturing and marketing of products within the therapy areas haemostasis management, growth hormone therapy, hormone replacement therapy, inflammation therapy and other therapy areas. No operating segments have been aggregated to form the above reportable operating segments. Management monitors the operating result of its business segments separately for the purpose of making decisions about resource allocation and performance assessment. Segment performance is evaluated based on operating profit consistent with the consolidated financial statements. Group financing (including financial expense and financial income) and income taxes are managed on a group basis and are not allocated to operating segments. Business segments DKK million Segment sales and results Sales Modern insulins (insulin analogues) Human insulins Insulin-related sales Oral antidiabetic products (OAD) Diabetes care total Haemostasis management Growth hormone therapy Hormone replacement therapy Other products Biopharmaceuticals total Sales Change in DKK (%) Change in local currencies (%) Cost of goods sold Sales and distribution costs Research and development costs – hereof costs related to discontinuation of all pulmonary diabetes projects Administrative expenses Licence fees and other operating income Operating profit Operating profit (excl cost related to discontinuation of all pulmonary diabetes projects) Share of profit in associated companies Financial income (net) Profit before income taxes Income taxes Net profit Other segment items Depreciation and amortisation Impairment losses in the Income statement Additions to property, plant and equipment and intangible assets (net) Long-term assets Total assets Total liabilities 2008 2007 2006 Diabetes care 17,317 11,804 1,844 2,391 14,008 12,572 1,749 2,149 10,825 13,451 1,606 1,984 33,356 30,478 27,866 33,356 9.4% 12.7% 8,705 10,497 4,791 (325) 1,936 142 7,569 7,894 30,478 9.4% 14.1% 8,404 9,962 6,116 (1,325) 1,916 179 4,259 5,584 27,866 16.1% 17.0% 8,123 9,257 3,898 – 1,748 142 4,982 – 1,899 208 1,628 16,037 30,468 8,398 1,774 931 1,995 16,884 30,257 7,980 1,632 45 2,499 17,606 29,714 7,470 Geographical information 2008 2007 2006 2008 2007 2006 DKK million Sales Change in DKK (%) Change in local currencies (%) Additions to property, plant and equipment and intangible assets (net) Property, plant and equipment Total assets Europe *) North America 17,219 5.3% 6.7% 1,458 15,624 40,849 16,350 6.9% 6.8% 1,651 16,398 38,428 15,300 9.1% 8.9% 2,065 16,765 35,232 15,154 10.2% 17.7% 137 973 3,532 13,746 11.9% 21.8% 509 998 2,873 12,280 28.8% 29.4% 460 1,480 3,819 *) The country of domicile for Novo Nordisk is disclosed as Europe in the geographical information. 62 Novo Nordisk Annual Report 2008 Consolidated financial statements Notes – Consolidated financial statements 4 Segment information (continued) There are no sales or other transactions between the business segments. Costs have been split between business segments based on a specific alloca- tion with the addition of a minor number of corporate overheads allocated systematically to the segments. Other operating income has been allocated to the two segments based on the same principle. Segment assets comprise the assets that are applied directly to the activities of the segment, including intangible assets, property, plant and equipment, long-term financial assets, inventories, trade receivables and other receivables. Segment liabilities com- prise liabilities derived from the activities of the segment, including provisions, trade payables and other liabilities. No single customer represents 10% or more of the total revenue. Geographical information The Group operates in four main geographical areas: Europe: EU, EFTA, Albania, Bosnia-Herzegovina, Croatia, Macedonia, Serbia & Montenegro and Kosovo North America: The US and Canada Japan & Oceania: Japan, Australia and New Zealand International Operations: All other countries Sales are attributed to geographical regions based on the location of the customer. There are no sales between regions. Total assets and additions to property, plant and equipment and intangible assets are based on the location of the assets. 2008 2007 2006 2008 2007 2006 2008 2007 2006 Biopharmaceuticals Corporate/unallocated Total 6,396 3,865 1,612 324 5,865 3,511 1,668 309 5,635 3,309 1,607 326 12,197 11,353 10,877 12,197 7.4% 11.1% 1,404 2,369 3,065 – 699 144 4,804 4,804 11,353 4.4% 9.9% 1,389 2,409 2,422 – 592 142 4,683 4,683 10,877 11.6% 12.7% 1,462 2,351 2,418 – 639 130 4,137 – 17,317 11,804 1,844 2,391 14,008 12,572 1,749 2,149 10,825 13,451 1,606 1,984 33,356 30,478 27,866 6,396 3,865 1,612 324 5,865 3,511 1,668 309 5,635 3,309 1,607 326 12,197 11,353 10,877 45,553 8.9% 12.2% 10,109 12,866 7,856 (325) 2,635 286 12,373 12,698 (124) 446 12,695 3,050 41,831 8.0% 12.9% 9,793 12,371 8,538 (1,325) 2,508 321 8,942 10,267 1,233 796 10,971 2,449 9,645 8,522 (124) 446 3,050 1,233 796 2,449 (260) 305 2,712 38,743 14.8% 15.7% 9,585 11,608 6,316 – 2,387 272 9,119 – (260) 305 9,164 2,712 6,452 1,963 179 3,009 23,857 44,692 14,570 284 3 329 3,220 6,640 2,448 263 – 391 3,470 6,685 2,488 291 – 509 3,684 6,783 2,269 47 1 – 2,282 13,495 6,778 37 2 – 3,075 10,789 5,081 40 134 1 2,567 8,195 4,831 2,230 212 1,957 21,539 50,603 17,624 2,074 933 2,386 23,429 47,731 15,549 2008 2007 2006 2008 2007 2006 2008 2007 2006 International Operations Japan & Oceania 8,425 15.5% 20.5% 354 1,827 5,267 7,295 12.3% 17.8% 222 2,031 5,648 6,494 18.1% 18.7% 465 1,897 4,618 4,755 7.1% 2.1% 8 215 955 4,440 (4.9%) 3.1% 4 178 782 4,669 (0.9%) 5.0% 19 208 1,023 45,553 8.9% 12.2% 1,957 18,639 50,603 Total 41,831 8.0% 12.9% 2,386 19,605 47,731 38,743 14.8% 15.7% 3,009 20,350 44,692 Novo Nordisk Annual Report 2008 63 Consolidated financial statements Notes – Consolidated financial statements 5 Sales rebate accruals and provisions 7 Depreciation, amortisation and impairment losses DKK million 2008 2007 2006 DKK million 2008 2007 2006 At the beginning of the year Additional rebates deducted from sales Adjustments to previous year’s accruals and provisions Payments and grants of rebates during the year Exchange rate adjustments 1,833 4,157 1,847 3,176 1,872 2,761 (209) (168) (218) (3,469) 88 (2,835) (187) (2,372) (196) At the end of the year 2,400 1,833 1,847 Included in the Income statement under the following headings: Cost of goods sold Sales and distribution costs Research and development costs *) Administrative expenses Total depreciation, amortisation and impairment losses 1,831 38 473 100 1,652 31 1,205 119 1,682 56 302 102 2,442 3,007 2,142 Specification of sales rebate accruals and provisions: Other liabilities Current provisions 119 2,281 89 1,744 72 1,775 *) Hereof costs of DKK 53 million in 2008 related to discontinuation of all pulmonary diabetes projects (DKK 870 million in 2007). Total sales rebate accruals and provisions 2,400 1,833 1,847 8 Fees to statutory auditors 6 Employee costs DKK million 2008 2007 2006 Wages and salaries Share-based payment costs (refer to note 33) Pensions – defined contribution plans Retirement benefit obligations (refer to note 24) Other contributions to social security Other employee costs 10,541 331 745 128 714 1,169 9,792 130 724 109 709 1,094 9,225 113 670 111 645 911 Total employee costs 13,628 12,558 11,675 Included in the Income statement under the following headings: Cost of goods sold Sales and distribution costs Research and development costs Administrative expenses 3,676 5,083 3,040 1,654 3,519 4,498 2,813 1,563 3,632 3,904 2,424 1,523 Total included in the Income statement 13,453 12,393 11,483 In addition the following employee cost are consolidated in other operating income (net): NNE Pharmaplan A/S NNIT A/S Included in the Balance sheet as: Capitalised employee costs related to assets in course of construction etc Change in employee costs included in inventories Total included in the Balance sheet 897 760 29 146 175 800 642 58 107 165 545 556 115 77 192 DKK million 2008 2007 2006 Statutory audit Audit-related services Tax advisory services Other services Total 25 4 16 1 46 25 6 15 1 47 24 7 16 1 48 9 Licence fees and other operating income (net) DKK million 2008 2007 2006 Licence fees Net income from IT, engineering and other services Other income Total licence fees and other operating income (net) 146 50 90 229 148 26 66 55 69 286 321 272 10 Financial income DKK million 2008 2007 2006 Interest income *) Capital gain on investments etc (net) Foreign exchange gain on derivative financial instruments (net) Gains on currency options 631 – 462 34 322 – 911 70 Total financial income 1,127 1,303 369 153 407 2 931 *) 2008 includes interest income related to the conclusion of the antidumping case in Brazil. Total employee costs 13,628 12,558 11,675 11 Financial expenses In addition the following employee cost have been capitalised as assets in course of construction NNE Pharmaplan A/S 297 264 545 For information on remuneration to the Board of Directors and Executive Management, please refer to note 34. DKK million 2008 2007 2006 Interest expenses Capital loss on investments etc (net) *) Foreign exchange loss (net) Other financial expenses Total financial expenses 246 28 355 52 681 324 60 71 52 507 296 – 268 62 626 Average number of full-time employees Year-end number of full-time employees 26,069 26,575 24,344 25,516 22,590 23,172 *) Including unrealised capital loss of DKK 52 million related to Novo Nordisk’s investment in Aradigm Inc. in 2007. 64 Novo Nordisk Annual Report 2008 Consolidated financial statements Notes – Consolidated financial statements 12 Income taxes DKK million Current tax on profit for the year Deferred tax on profit for the year Tax on profit for the year Adjustments related to previous years – current tax Adjustments related to previous years – deferred tax Income taxes in the Income statement Tax on entries in equity related to current tax Tax on entries in equity related to deferred tax Tax on entries in equity Computation of effective tax rate: Statutory corporate income tax rate in Denmark Deviation in foreign subsidiaries’ tax rates compared to the Danish tax rate (net) Non-tax income less non-tax deductible expenses (net) Effect on deferred tax related to change in the Danish tax rate in 2007 Other 2008 2,233 851 3,084 (218) 184 3,050 27 (108) (81) 25.0% (0.3%) (0.4%) – (0.3%) 2007 2006 2,835 (347) 2,488 (11) (28) 2,449 43 50 93 25.0% 2.9% (3.2%) (2.0%) (0.4%) 2,832 (213) 2,619 964 (871) 2,712 4 125 129 28.0% 2.1% (0.4%) – (0.1%) Effective tax rate 24.0% 22.3% 29.6% 13 Earnings per share DKK million Net profit 2008 9,645 2007 8,522 2006 6,452 Average number of shares outstanding *) Dilutive effect of outstanding share bonus pool and options ‘in the money’ **) in 1,000 shares in 1,000 shares 615,780 4,947 631,783 4,639 641,862 3,526 Average number of shares outstanding incl dilutive effect of options ‘in the money’ in 1,000 shares 620,727 636,422 645,388 Basic earnings per share *) Diluted earnings per share *) DKK DKK 15.66 15.54 13.49 13.39 10.05 10.00 In 2007 there was a stock split of the company’s A and B shares. The trade unit was changed from DKK 2 to DKK 1. The comparative figures for 2006 have been updated accordingly. *) **) For further information on outstanding share bonus pool and options, please refer to note 33. Novo Nordisk Annual Report 2008 65 Consolidated financial statements Notes – Consolidated financial statements 14 Intangible assets DKK million 2008 Cost at the beginning of 2008 Additions during the year Disposals during the year Exchange rate adjustments Cost at the end of 2008 Amortisation and impairment losses at the beginning of 2008 Amortisation for the year Impairment losses for the year Amortisation reversed on disposals during the year Exchange rate adjustments Amortisation and impairment losses at the end of 2008 Carrying amount at the end of 2008 2007 Cost at the beginning of 2007 Additions during the year Addition regarding acquisitions Disposals during the year Exchange rate adjustments Cost at the end of 2007 Amortisation and impairment losses at the beginning of 2007 Amortisation for the year Impairment losses for the year **) Amortisation reversed on disposals during the year Exchange rate adjustments Amortisation and impairment losses at the end of 2007 Carrying amount at the end of 2007 Includes primarily internally developed software and costs related to major IT projects. *) **) Impairment losses of DKK 117 million relates to discontinuation of AERx ®. Goodwill Patents and licences etc Other intangible assets *) 133 5 (2) – 136 65 – – – – 65 71 82 52 – (1) – 133 65 – – – – 65 68 520 172 – 8 700 153 16 50 – – 219 481 486 21 26 (11) (2) 520 22 14 117 (1) 1 153 367 572 22 (7) 22 609 336 34 8 (5) 0 373 236 491 97 18 (41) 7 572 333 32 – (37) 8 336 236 Total 1,225 199 (9) 30 1,445 554 50 58 (5) 0 657 788 1,059 170 44 (53) 5 1,225 420 46 117 (38) 9 554 671 66 Novo Nordisk Annual Report 2008 Consolidated financial statements Notes – Consolidated financial statements 15 Property, plant and equipment DKK million 2008 Cost at the beginning of 2008 Additions during the year Addition regarding acquisitions Disposals during the year Transfer from/(to) other items Exchange rate adjustments Cost at the end of 2008 Depreciation and impairment losses at the beginning of 2008 Depreciation for the year Impairment losses for the year *) Depreciation reversed on disposals during the year Exchange rate adjustments Depreciation and impairment losses at the end of 2008 Land and buildings Plant and machinery Other equipment Total Payments on account and assets in course of construction 12,208 164 – (448) 472 (116) 15,564 261 – (335) 378 (169) 12,280 15,699 3,618 516 6 (333) (15) 3,792 7,317 1,399 92 (311) (26) 8,471 2,289 164 – (183) 335 15 2,620 1,366 265 3 (152) 4 1,486 2,547 1,183 – (795) (1,185) 39 32,608 1,772 – (1,761) – (231) 1,789 32,388 702 – 53 (755) – 13,003 2,180 154 (1,551) (37) – 13,749 Carrying amount at the end of 2008 8,488 7,228 1,134 1,789 18,639 2007 Cost at the beginning of 2007 Additions during the year Addition regarding acquisitions Disposals during the year Transfer from/(to) other items Exchange rate adjustments Cost at the end of 2007 Depreciation and impairment losses at the beginning of 2007 Depreciation for the year Impairment losses for the year *) Depreciation reversed on disposals during the year Exchange rate adjustments Depreciation and impairment losses at the end of 2007 11,525 284 7 (241) 640 (7) 14,066 387 – (720) 1,847 (16) 12,208 15,564 3,231 500 30 (133) (10) 3,618 6,677 1,302 25 (685) (2) 7,317 2,623 203 2 (646) 129 (22) 2,289 1,731 226 26 (609) (8) 1,366 3,775 1,434 – (33) (2,616) (13) 31,989 2,308 9 (1,640) 0 (58) 2,547 32,608 – – 735 (33) – 702 11,639 2,028 816 (1,460) (20) 13,003 Carrying amount at the end of 2007 8,590 8,247 923 1,845 19,605 *) Impairment losses of DKK 53 million relates to discontinuation of all pulmonary diabetes projects in 2008 (DKK 753 million in 2007). 16 Investments in associated companies DKK million Aggregated financial information of associated companies: Sales Net profit/(loss) Total assets Total liabilities Novo Nordisk’s share of profit/(loss) in associated companies Hereof unrealised capital gains/(losses) Novo Nordisk’s carrying amount of investments in associated companies Hereof Novo Nordisk’s carrying amount of goodwill related to investments in associated companies Market values of shareholdings in listed associated companies: – ZymoGenetics, Inc. (NASDAQ symbol: ZGEN) – Innate Pharma SA (Euronext symbol: IPH) 2008 2007 88 (681) 1,750 1,062 (124) – 222 69 331 48 333 4,944 3,581 880 1,233 15 500 69 1,237 128 Novo Nordisk recorded in 2007 an income of DKK 1,518 million related to the divestment of the business activities in Dako A/S. As a shareholder in Harno Invest A/S (formerly Dako A/S) Novo Nordisk received a dividend of DKK 170 million in 2008 (DKK 1,470 million in 2007). Please refer to page 101 for a list of Novo Nordisk’s associated companies. Novo Nordisk Annual Report 2008 67 ‘Loans and Receivables’ ‘Assets at fair value through profit and loss’ ‘Derivatives used for hedging’ ‘Available for sale’ Total – – – 41 – 41 7,692 8,781 16,514 – – – – 365 365 – – 365 – – – – – – – – – 3 165 997 – – 1,165 – – 3 165 997 41 365 1,571 7,692 8,781 1,165 18,044 ‘Liabilities at fair value through profit and loss’ ‘Derivatives used for hedging’ ‘Other financial liabilities at amortised cost’ – – 1,279 – 1,279 980 55 – 7,999 9,034 – – – – – (9) 997 1.5 4.3% Total 980 55 1,279 7,999 10,313 Consolidated financial statements Notes – Consolidated financial statements 17 Financial instruments DKK million 2008 Assets as per balance sheet Available-for-sale financial assets: – Listed shares – Unlisted shares – Bonds *) Loans Derivative financial instruments (refer to note 35) Other financial assets and Marketable securities and financial derivatives Trade and other receivables excluding prepayments (refer to note 19 and 20) Cash at bank and in hand (refer to note 30) Total DKK million 2008 Liabilities as per balance sheet Long-term debt (refer to note 22) Bank loans and overdrafts (refer to note 26) Derivative financial instruments (refer to note 35) Trade and other payables excluding statutory liabilities (refer to Trade payables and note 27) Total Revaluation surplus on available-for-sale financial assets recognised in equity during the year Bonds with maturity exceeding 12 months from the balance sheet date Duration of the Group’s bond portfolio (years) Redemption yield on the Group’s bond portfolio 68 Novo Nordisk Annual Report 2008 17 Financial instruments (continued) DKK million 2007 Assets as per balance sheet Available-for-sale financial assets: – Listed shares – Unlisted shares – Bonds *) Loans Derivative financial instruments (refer to note 35) Other financial assets and Marketable securities and financial derivatives Trade and other receivables excluding prepayments (refer to note 19 and 20) Cash at bank and in hand (refer to note 30) Total DKK million Consolidated financial statements Notes – Consolidated financial statements ‘Loans and Receivables’ ‘Assets at fair value through profit and loss’ ‘Derivatives used for hedging’ ‘Available for sale’ Total – – – 40 – 40 6,983 4,823 – – – – 1,048 1,048 – – 11,846 1,048 – – – – – – – – – 5 107 1,486 – – 1,598 – – 5 107 1,486 40 1,048 2,686 6,983 4,823 1,598 14,492 ‘Liabilities at fair value through profit and loss’ ‘Derivatives used for hedging’ ‘Other financial liabilities at amortised cost’ 2007 Liabilities as per balance sheet Long-term debt (refer to note 22) Long-term debt due within one year (refer to note 26) Bank loans and overdrafts (refer to note 26) Derivative financial instruments (refer to note 35) Trade and other payables excluding statutory liabilities (refer to Trade payables and note 27) Total Revaluation surplus on available-for-sale financial assets recognised in equity during the year Bonds with maturity exceeding 12 months from the balance sheet date Duration of the Group’s bond portfolio (years) Redemption yield on the Group’s bond portfolio – – – – – – 12 985 1.6 4.4% – – – 45 – 45 961 154 206 – 6,560 7,881 *) Danish AAA-rated mortgage bonds issued by Danish credit institutions governed by The Danish Financial Supervisory Authority. For a description of Credit quality of financial assets such as ‘Trade receivables’, ‘Cash at bank and short term bank deposits’ and ‘Derivative financial assets’ please refer to note 31. Total 961 154 206 45 6,560 7,926 Novo Nordisk Annual Report 2008 69 Consolidated financial statements Notes – Consolidated financial statements 18 Inventories DKK million Raw materials and consumables Work in progress Finished goods Total inventories 20 Other receivables 2008 2007 DKK million 1,279 6,659 1,673 1,210 6,010 1,800 9,611 9,020 Prepayments Interest receivable Amounts owed by affiliated companies Rent deposit Other receivables 2008 2007 593 54 146 305 606 602 79 105 254 453 Total other receivables 1,704 1,493 Indirect production costs included in work in progress and finished goods 4,633 4,418 Amount of write-down of inventories recognised as expense during the year *) Amount of reversal of write-down of inventories during the year 733 188 48 81 *) Write-downs in 2008 include a few batches of bulk insulin with impurities. 19 Trade receivables DKK million Trade receivables (gross) Allowances for doubtful trade receivables: Balance at the beginning of the year Change in allowances during the year Realised losses during the year Balance at the end of the year 2008 2007 7,183 6,634 542 69 (9) 602 459 119 (36) 542 Total trade receivables 6,581 6,092 Trade receivables (net) are equal to an average credit period of (days) 53 53 Trade receivables (gross) can be specified as follows: Not due 5,699 5,255 Overdue by: Between 1 and 179 days Between 180 and 359 days More than 360 days Total trade receivables (gross) 901 263 320 835 182 362 7,183 6,634 70 Novo Nordisk Annual Report 2008 21 Share capital DKK million Development in share capital: A share capital B share capital At the end of the year Consolidated financial statements Notes – Consolidated financial statements 2008 2007 107 527 634 107 540 647 The A share capital remained unchanged at DKK 107 million from 2004 to 2008. In 2008 the B share capital was reduced by DKK 13 million from DKK 540 million to DKK 527 million. In 2007 the B share capital was reduced by DKK 27 million from DKK 567 million to DKK 540 million. In 2006 the B share capital was reduced by DKK 35 million from DKK 602 million to DKK 567 million. The B share capital remained 602 million from 2004 to 2005. See ‘Shares and capital structure’ on page 49. At the end of 2008, the share capital amounted to DKK 107,487,200 in A share capital (equal to 107,487,200 A shares of DKK 1) and DKK 526,512,800 in B share capital (equal to 526,512,800 B shares of DKK 1). Treasury shares: Holding at the beginning of the year Cancellation of treasury shares Holding of treasury shares, adjusted for cancellation Purchase during the year Sale during the year Value adjustment Holding at the end of the year Number of As % of share capital before cancellation B shares of DKK 1 As % of share capital after cancellation Market value DKK million 25,815,130 (12,960,000) 3.99% (2.00%) 12,855,130 1.99% 2.03% 15,579,207 (2,713,242) 2.46% (0.43%) 8,648 (3,950) 4,306 4,717 (295) (1,758) 25,721,095 4.06% 6,970 Acquisition of treasury shares during the year is part of the 2006 to 2009 share buy-back programme of Novo Nordisk B shares. The programme was initiated in order to align the capital structure with the expected development in free cash flow. Sale of treasury shares relates to exercised share options and employee shares. At the end of the year 8,840,007 of the treasury B shareholding shares are regarded as hedge for the share-based incentive schemes and restricted stock awards to employees. 22 Long-term debt DKK million Mortgage debt and other secured loans *) Unsecured loans and other long-term loans **) Total long-term debt The debt is payable within the following periods as from the balance sheet date: Between one and two years Between two and three years Between three and four years Between four and five years After five years Total long-term debt The debt is denominated in the following currencies: DKK EUR USD Total long-term debt Adjustment of the above loans to market value at year-end 2008 would result in a loss of DKK 2 million (a loss of DKK 2 million in 2007). *) Terms to maturity between 2016 – 2022 and a weighted average interest rate of 4.09%. **) Terms to maturity in 2011 and a weighted average interest rate of 1.63%. 2008 2007 504 476 980 0 476 0 42 462 980 2 502 476 980 504 457 961 0 0 457 0 504 961 2 502 457 961 Novo Nordisk Annual Report 2008 71 Consolidated financial statements Notes – Consolidated financial statements 23 Deferred income tax assets and liabilities DKK million At the beginning of the year Deferred tax on profit for the year Adjustment relating to previous years Deferred tax on items recognised on equity Addition regarding acquisition Exchange rate adjustments Total deferred tax (assets)/liabilities (net) DKK million Assets Liabilities Specification The deferred tax assets and liabilities are allocable to the various balance sheet items as follows: Property, plant and equipment Intangible assets Indirect production costs Unrealised profit on intercompany sales Allowances for doubtful trade receivables Tax-loss carry-forward Other Netting of deferred tax assets and deferred tax liabilities related to income taxes for which there is a legally enforceable right to offset Total deferred tax (assets)/liabilities (net) (129) (628) – (1,997) (72) (52) (453) (3,331) 1,502 7 1,158 – 2 – 1,370 4,039 1,635 (1,635) (1,696) 2,404 2008 Total 1,373 (621) 1,158 (1,997) (70) (52) 917 708 – 708 2008 2007 (176) 851 184 (108) – (43) 708 Assets Liabilities (451) (677) – (1,643) (61) (22) (1,188) (4,042) 1,321 1 1,103 – 1 – 1,440 3,866 1,520 (1,520) (2,522) 2,346 87 (347) (28) 50 7 55 (176) 2007 Total 870 (676) 1,103 (1,643) (60) (22) 252 (176) – (176) Tax-loss carry-forward Deferred tax assets are recognised on tax-loss carry-forwards that represent income likely to be realised in the future. The deferred tax assets of a tax loss of DKK 276 million (DKK 224 million in 2007) have not been recognised in the Balance sheet. Hereof DKK 15 million expire within three years. 72 Novo Nordisk Annual Report 2008 Consolidated financial statements Notes – Consolidated financial statements 24 Retirement benefit obligations Most employees in the Group are covered by post-employment retirement plans in the form of primarily defined contribution plans or alternatively defined benefit plans. Group companies sponsor these plans either directly or by contributing to independently administered funds. The nature of such plans varies according to the legal regulations, fiscal requirements and economic conditions of the countries in which the employees are employed, and the benefits are generally based on the employees’ remuneration and years of service. The obligations relate both to existing retirees’ pensions and to pension entitlements of future retirees. Other post-employment benefits consist mostly of post-retirement healthcare plans, principally in the United States. Post-employment benefit plans are usually funded by payments from Group companies and by employees to funds independent of the Group. Where a plan is unfunded, a liability for the retirement obligation is recognised in the Group’s Balance sheet. In accordance with the Accounting Policies the costs recognised for post-employment benefits are included in Cost of goods sold, Sales and distribution costs, Research and development costs or Administrative expenses. The following shows a five-year summary reflecting the funding of retirement obligations and the impact of historical deviations between expected and actual return on plan assets and actuarial adjustments on plan liabilities: DKK million Retirement obligations Plan assets Deficit/(surplus) Unrecognised gains/(loss) Retirement obligations recognised in the balance sheet Actuarial (gains)/losses on plan assets Actuarial (gains)/losses on plan liabilities 2008 2007 2006 2005 2004 1,103 (649) 454 (35) 419 56 24 885 (566) 319 43 362 (3) (151) 938 (495) 443 (113) 330 (3) 7 875 (435) 440 (124) 316 6 77 609 (313) 296 (46) 250 (2) 16 DKK million 2008 2007 DKK million 2008 2007 Balance sheet obligations for Defined benefit pension plans Post-employment medical benefits Total retirement obligations Change/development in the retirement obligations of the year At the beginning of the year Current service cost Interest cost on pension obligation Actuarial (gains)/losses Past service costs Benefits paid to employees Addition regarding acquisition Changed classification of pensions plans Plan amendments Other Exchange rate adjustments At the end of the year Change/development in the fair value of plan assets of the year At the beginning of the year Expected return on plan assets Actuarial gains/(losses) Employer contributions Benefits paid to employees Addition regarding acquisition Changed classification of pensions plans Other Exchange rate adjustments At the end of the year 907 196 1,103 738 147 885 Weighted average asset allocation of funded retirement obligations Equities Bonds Cash at bank Property 885 112 41 24 1 (52) – 17 – 3 72 1,103 566 24 (56) 81 (24) – 11 3 44 649 938 91 32 (151) – (23) 31 – 3 – (36) 885 495 18 3 68 (10) 1 – – (9) 566 22% 58% 15% 5% 27% 56% 12% 5% 870 (649) 221 233 (68) 36 (3) 695 (566) 129 190 2 44 (3) The amounts recognised in the Balance sheet are determined as Present value of funded obligations Fair value of plan assets Present value of unfunded obligations Unrecognised actuarial gains/(losses) (net) on pension benefit plans Unrecognised actuarial gains/(losses) (net) on post-employment medical plans Unrecognised past service costs Net liability in the Balance sheet 419 362 Amounts recognised in the Balance sheet for post-employment defined benefit pension plans and medical plans are predominantly non-current and are reported as either long-term assets or long-term liabilities. Change/development in the retirement obligations recognised in the balance sheet Net liability at the beginning of the year Recognised in the income statement for the year Employer contributions Benefit paid to employees, net Exchange rate adjustment Plan amendments Addition regarding acquisition Changed classification of pensions plans Other At the end of the year 362 128 (81) (28) 28 – – 6 4 419 330 109 (68) (13) (27) 3 30 – (2) 362 Novo Nordisk Annual Report 2008 73 Consolidated financial statements Notes – Consolidated financial statements 24 Retirement benefit obligations (continued) DKK million 2008 2007 DKK million 2008 2007 Income statement charge for Defined benefit pension plans Post-employment medical benefits Total income statement charge 92 36 128 79 30 109 The Group expects to contribute DKK 68 million to its defined benefit pension plans in 2009. The weighted average assumptions used for computation and valuation of defined benefit plans and post-employment medical benefits are as follows Discount rate Projected return on plan assets Projected future remuneration increases Healthcare cost trend rate Inflation rate 5% 4% 4% 6% 2% 4% 4% 3% 7% 2% Amounts recognised in the income statement for the year Current service cost Interest cost on pension obligation Expected return on plan assets Actuarial (gains)/losses recognised in the year Past service cost Total income statement charge Actual return on plan assets 112 41 (24) (2) 1 128 (33) 91 32 (18) 1 3 109 21 For all major defined benefit plans actuarial computations and valuations are performed annually. 25 Other provisions DKK million At the beginning of the year Additional provisions *) Adjustments to previous year’s provisions Used during the year Exchange rate adjustments At the end of the year Specification of other provisions: Long-term *) Current Total other provisions Provisions for returned products Provisions for sales rebates Other provisions 2008 Total 3,640 3,975 (329) (3,555) 55 2007 Total 3,367 3,510 (316) (2,731) (190) 1,303 46 (25) (385) (28) 911 3,786 3,640 863 48 911 863 2,923 3,786 1,239 2,401 3,640 593 236 (95) (151) 11 594 – 594 594 1,744 3,693 (209) (3,019) 72 2,281 – 2,281 2,281 *) DKK 339 million in 2007 relates to discontinuation of AERx ®. Provisions for returned products: Novo Nordisk issues credit notes for expired goods as a part of normal business. Consequently, a provision for future returns is made based on historical statistical product returns, which represents management’s best estimate. The provision is expected to be used within the normal operating cycle. Provisions for sales rebates: In some countries the actual rebates depend on which customers purchase the products. Factors that complicate the rebate calculations are the identification of which products have been sold subject to a rebate, which customer or government price terms apply, and the estimated lag time between sale and payment of the rebate. Please refer to notes 3 and 5 for further information on rebates deducted from sales. Other provisions: Other provisions consist of various types of provisions including provisions for legal disputes, which represents management’s best estimate. Please refer to note 36 for further information on commitments and contingencies. 74 Novo Nordisk Annual Report 2008 Consolidated financial statements Notes – Consolidated financial statements 26 Short-term debt and financial derivatives 28 Other adjustments for non-cash items DKK million 2008 2007 DKK million 2008 2007 2006 Bank loans and overdrafts Long-term debt, amounts falling due within one year Derivative financial instruments (refer to note 35) Total short-term debt The debt is denominated in the following currencies: DKK EUR USD JPY Other currencies Total short-term debt 55 – 1,279 1,334 21 40 601 672 – 1,334 206 154 45 405 13 179 108 11 94 405 At year-end, the Group had undrawn committed credit facilities amounting to DKK 7,451 million (DKK 7,457 million in 2007). The undrawn committed credit facilities consist of a EUR 400 million and a EUR 600 million facility committed by a number of Danish and international banks. The facilities mature in 2009 and 2012 respectively. Share-based payment costs Increase/(decrease) in provisions (Gain)/loss from sale of property, plant and equipment Change in allowances for doubtful trade receivables Unrealised (gain)/loss on shares and bonds etc Unrealised foreign exchange (gain)/loss Share of (profit)/loss in associated companies Recognised income of divestment of business activities in the associated company Harno Invest A/S Unrealised capital gain on investments in associated companies Other, including difference between average exchange rate and year-end exchange rate 331 221 95 69 30 24 195 130 490 140 119 54 37 300 (71) (1,518) – 542 (15) (46) 113 889 134 65 (7) (143) 244 – 16 (352) Other adjustments for non-cash items 1,436 (309) 959 27 Other liabilities DKK million Employee costs payable Taxes and duties payable Accruals and deferred income Amounts owed to affiliated companies Other payables Total other liabilities 29 Cash flows from acquisition of subsidiaries and business units 2008 2007 DKK million 2008 2007 2006 2,272 135 78 79 3,289 2,025 346 122 93 2,373 5,853 4,959 Intangible assets Property, plant and equipment Other long-term assets Current assets Long-term liabilities Current liabilities Net assets acquired Goodwill on acquisition Consideration paid Acquired cash and cash equivalents Net cash flow Please refer to note 2 for further information. – – – – – – – – – – – 44 9 18 149 (37) (176) 7 52 (59) – (59) – – – – – – – – – – – 30 Cash and cash equivalents DKK million 2008 2007 2006 Cash at the end of the year Short-term bank loans and overdrafts at the end of the year (refer to note 26) 8,781 4,823 3,270 (55) (206) (285) Cash and cash equivalents at the end of the year 8,726 4,617 2,985 At the end of 2008, 2007 and 2006 there were no marketable securities with original maturity of less than three months. Novo Nordisk Annual Report 2008 75 Consolidated financial statements Notes – Consolidated financial statements 31 Financial risk Novo Nordisk has centralised the management of the Group’s financial risks. The overall objective and policies for the company’s financial risk manage- ment are outlined in the Treasury Policy, which is approved by the Board of Directors. The Treasury Policy consists of the Foreign Exchange Policy, the Investment Policy, the Financing Policy and the Policy regarding Credit Risk on Financial Counterparts, and includes a description of allowed financial instruments and risk limits. Novo Nordisk only hedges commercial exposures and consequently does not enter into derivative transactions for trading or speculative purposes. Novo Nordisk uses a fully integrated Treasury Management System to manage all financial positions. All positions are marked-to-market based on real-time quotes and risk is assessed using generally accepted standards. Foreign exchange risk Foreign exchange risk is the principal financial risk within Novo Nordisk and as such has a significant impact on the Income statement and the Balance sheet. The major part of Novo Nordisk’s sales is in EUR, USD, JPY, and GBP, while a predominant part of production, research, and development costs is carried in DKK. As a consequence, Novo Nordisk’s foreign exchange risk is most significant in USD, JPY and GBP, leaving out EUR for which the exchange rate risk is regarded as low due to the Danish fixed-rate policy vis-à-vis the EUR. In addition, International Operations’ share of sales is continuously increasing and the implied foreign exchange risk is becoming more important. The overall objective of foreign exchange risk management is to limit the short-term negative impact on earnings and cash flow from exchange rate fluctuations, thereby increasing the predictability of the financial results. Novo Nordisk hedges existing assets and liabilities in major currencies as well as future expected cash flows up to 24 months forward. Currency hedging is based upon expectations of future exchange rates and takes place using mainly foreign exchange forwards and foreign exchange options matching the due dates of the hedged items. Expected cash flows are continuously assessed using historical inflows, budgets and monthly sales forecasts. Hedge effectiveness is assessed on a regular basis. In 2008, financial markets have been characterised by elevated uncertainty. As a result, volatility has been higher in all financial markets including the foreign exchange market. USD fluctuated significantly but ended 2008 with an appreciation of 4.1% versus DKK. In 2007 the USD depreciated by 10.4% versus DKK. Movements in the JPY and the GBP were likewise abnormally high. The JPY appreciated by 30.3%, whereas the GBP depreciated by 24.6%, both versus DKK. In 2007, the JPY depreciated by 5.5% whereas the GBP appreciated by 8.6%. Emerging market currencies impacting sales of Inter - national Operations overall weakened quite significantly because of the financial crisis and increased risk aversion. At year-end 2008 Novo Nordisk has covered the foreign exchange exposures on the Balance sheet together with 15 months of expected future cash flow in USD. For both JPY and GBP the equivalent cover was 13 months of expected future cash flow. At the end of 2007, the USD cover was 16 months, and for JPY and GBP the cover was 15 months and 10 months, respectively. A 5% change in the following currencies will have a full-year impact on operating profit of approximately: DKK million USD JPY GBP CNY CAD Estimated for 2009 Estimated for 2008 530 150 80 80 40 470 140 85 65 35 At the end of 2008 a 5% increase in all other currencies versus EUR and DKK would result in a decrease of the value of the net financial instruments of the Group of approximately DKK 661 million (DKK 714 million in 2007). A 5% de- crease in all other currencies versus EUR and DKK would result in an increase of the value of the net financial instruments of the Group of approximately DKK 669 million (DKK 772 million in 2007). The financial instruments included in the foreign exchange sensitivity analysis are the Group’s cash, accounts receivable and payable, short- and long-term loans, short- and long-term financial investments, foreign exchange forwards, and foreign exchange options hedging transaction exposure. Furthermore, interest rate swaps and cross-currency swaps are included. Not included are anticipated currency transactions, investments, and fixed assets. Cross- currency swaps hedging translation exposure are excluded from the sensitivity analysis, as the effects of changing exchange rates hereon are recognised directly under shareholders’ funds. Novo Nordisk only hedges invested equity in major foreign affiliates to a very limited extent. Equity hedging takes place using long-term cross-currency swaps. At the end of 2008, hedged equity made up 12% of the Group’s JPY equity. At the end of 2007, 12% of the Group’s JPY equity was hedged. Interest rate risk The volatility of the financial markets also impacted interest rates. During 2008, DKK and EUR interest rates experienced high volatility and ended the year with a significant decline. The Danish two-year interest rate swap was 3.57% at the end of 2008, down from 4.23% at the end of 2007. Changes in the interest rates have an effect on Novo Nordisk’s financial instruments. At the end of 2008, an increase in the interest rate level of one percentage point would, everything else being equal, increase the fair value of Novo Nordisk’s financial instruments by DKK 19 million (DKK 15 million in 2007). The financial instruments included in the sensitivity analysis consist of market - able securities, deposits, short- and long-term loans, interest rate swaps and cross-currency swaps. Not included are foreign exchange forwards and foreign exchange options due to the limited effect that a parallel shift in interest rates in all currencies have on these instruments. Liquidity risk Novo Nordisk ensures availability of required liquidity through a combination of cash management, highly liquid investment portfolios and uncommitted as well as committed facilities. Counterparty risk The use of derivative financial instruments and money market deposits gives rise to counterparty exposure. To manage the credit risk on financial counter- parties, Novo Nordisk only enters into derivative financial contracts with financial counterparties having a satisfactory long-term credit rating assigned by international credit rating agencies. Money market deposits are only entered into with financial counterparties having a satisfactory credit rating. The majority of all deposits are secured by Danish State guarantee until 2010. Furthermore, maximum credit lines defined for each counterpart limit the overall counterpart risk. The credit risk on bonds is limited as investments are made in highly liquid bonds with solid credit ratings. Credit risk on Trade and Other receivables is limited as Novo Nordisk has no significant concentration of credit risk, with exposure being spread over a large number of counterparties and customers. Capital structure Novo Nordisk’s capital structure is characterised by a substantial equity ratio. This is in line with the general capital structure of the pharmaceutical industry and reflects the inherent long-term investment horizons in an industry with typically more than 10 years’ development time for pharmaceutical products. Novo Nordisk’s equity ratio, calculated as equity to total liabilities, was 65.2% by the end of the year (67.4% at the end of 2007). 76 Novo Nordisk Annual Report 2008 Consolidated financial statements Notes – Consolidated financial statements 32 Related party transactions Novo Nordisk A/S is controlled by Novo A/S (incorporated in Denmark), which owns 25.5% of the shares in Novo Nordisk A/S. The remaining shares are widely held. The ultimate parent of the Group is the Novo Nordisk Foundation (incorporated in Denmark). Both entities are considered related parties. Other related parties are considered to be the Novozymes Group due to joint ownership, associated companies, the directors and officers of these entities and management of Novo Nordisk A/S. Following the demerger of NovoZymes in November 2000, Novo Nordisk A/S has access to certain assets of and may purchase certain services from Novo A/S and the Novozymes Group and vice versa. All agreements relating to such assets and services are based on the list prices used for sales to third parties where such list prices exist, or the price has been set at what is regarded as market price. The main part of these agree ments covers one year. The Group has had the following material transactions with related parties: DKK million Novo Nordisk Foundation Donations to the Group Novo A/S Services provided by the Group Facilitation provided by Novo A/S Purchase of Novo Nordisk B shares Sale of treasury shares (related to share options) Net balance The Novozymes Group Services provided by the Group Services provided by the Novozymes Group Net balance Associated companies Purchased intangible assets, fees and royalties etc paid to associated companies by Novo Nordisk Received intangible assets, fees and royalties etc from associated companies to Novo Nordisk 2008 Purchase/ (sale) 2007 Purchase/ (sale) (29) (30) (6) – 1,016 (9) 1 (284) 147 33 (7) 1 2,090 (8) 3 (253) 159 14 40 (12) 63 – There have not been any material transactions with any director or officer of Novo Nordisk, the Novozymes Group, Novo A/S, the Novo Nordisk Foundation or associated companies. For information on remuneration to the manage- ment of Novo Nordisk A/S, please refer to note 34. Apart from the balances included in the Balance sheet under Other financial assets, Other receivables and Other liabilities, there are no material unsettled transactions with related parties at the end of the year. Novo Nordisk Annual Report 2008 77 Consolidated financial statements Notes – Consolidated financial statements Share options Novo Nordisk had established share option schemes in 1998 –2006 with the purpose of motivating and retaining a qualified management group and to ensure common goals for management and the shareholders. Each option gives the right to purchase one Novo Nordisk B share. All share options are hedged by treasury shares. No options were granted in 2007 and 2008 as the future long-term incentive programme from 2007 onwards will be share based. The options are exercisable three years after the issue date and will expire after eight years. The exercise price for options granted based on per - formance targets for the financial years 2000 –2006 was equal to the market price of the Novo Nordisk B share at the time when the plan was established. The options can only be settled in shares. Assumptions The market value of the Novo Nordisk B share options has been calculated using the Black-Scholes option pricing model. The assumptions used are shown in the table below: Expected life of the option in years (average) Expected volatility Expected dividend per share (in DKK) Risk-free interest rate (based on Danish government bonds) Novo Nordisk B share price at the date of grant Novo Nordisk B share price at the end of the year 2008 2007 2006 6 29% 6.00 6 21% 4.50 6 17% 3.50 3.00% 4.25% 3.60% N/A N/A 195 271.0 335.0 235.5 Share options on Novozymes shares Options granted prior to the demerger of Novozymes A/S in 2000 have been split into one Novo Nordisk option and one Novozymes option. At the end of the year, the Group’s outstanding Novozymes options amount to 20,117 with an average exercise price of DKK 101 per share of DKK 10 and a market value of DKK 6 million. These options are hedged by the Group’s holding of Novozymes A/S B shares. 33 Share-based payment schemes DKK million 2008 2007 2006 Total share-based payment costs recognised in income statement Employee shares (DK based employees) Employee shares (Outside DK) Long-term share-based incentive programme (Senior management board) Long-term share-based incentive programme (Management group below Senior management board) *) 156 15 55 105 – 9 43 78 – 9 46 58 Share-based payment expensed in the Income statement 331 130 113 *) Includes long-term share-based incentive programme for 2007 and 2008 and share option programme for 2003 to 2006. Employee shares In 2008 a general employee share program was implemented in Denmark. Approximately 12,000 employees have purchased 1.2 million shares at a price of DKK 150 per share. Outside of Denmark the program is structured as share options with the same initial benefit per employee as in Denmark. Approximately 14,000 employees have been granted 694,500 shares. Long-term share-based incentive programme For a description of the programme please refer to pages 44– 45. In 2008, the allocation to the joint pool for the Senior Management Board amounts to DKK 55 million, corresponding to 8 months’ salary. This amount was expensed in 2008. The cash amount was converted into 171,492 Novo Nordisk B shares of DKK 1 using a share price of DKK 318, equal to the average trading price for Novo Nordisk B shares on the NASDAQ OMX Copenhagen from 31 January to 14 February 2008. Based on the split of participants at the establishment of the joint pool, approximately 35% of the pool will be allocated to the members of Executive Management and 65% to the members of the Senior Management Board. The shares allocated to the joint pool for 2005 (232,026 shares) were released to the individual participants on 29 January 2009 following the approval of the Annual Report 2008 by the Board of Directors. The total number of shares in the joint pool relating to the years 2006, 2007 and 2008 now amounts to 599,284 shares split in the following way: Year allocated to pool Number of shares Vesting 2006 2007 2008 261,500 166,292 171,492 599,284 2010 2011 2012 For the management group below the Senior Management Board, a similar share-based incentive programme was introduced in 2007. The allocation to the joint pool for this group consisting of approximately 500 employees was DKK 135 million in 2007, corresponding to 527,665 shares. The cost of this allocation will be amortised equally over the period 2007–2010. For 2008, this group consisted of about 550 employees. The allocation to the joint pool was DKK 181 million corresponding to 570,390 shares. The cost of this allocation will be amortised equally over the period 2008 –2011. Including cancelled allocations of 7,690 shares from 2007 this pool now consists of 1,090,365 shares. 78 Novo Nordisk Annual Report 2008 Consolidated financial statements Notes – Consolidated financial statements 33 Share-based payment schemes (continued) Outstanding share options in Novo Nordisk Outstanding at the end of 2005 Granted in respect of 2006 (issued on 31 January 2007) Exercised in 2006: of 1997 Ordinary share option plan of 1998 Ordinary share option plan of 1999 Ordinary share option plan of 2000 Ordinary share option plan of Launch share option plan of 2001 Ordinary share option plan of 2002 Launch share option plan of 2005 Employee share options *) Cancelled in 2006 Value adjustment ***) Outstanding at the end of 2006 Exercised in 2007: of 1998 Ordinary share option plan of 1999 Ordinary share option plan of 2000 Ordinary share option plan of 2001 Ordinary share option plan of Launch share option plan of 2001 Launch share option plan of 2002 Launch share option plan of 2003 Ordinary share option plan of 2005 Employee share options *) Expired in 2007 Cancelled in 2007 Value adjustment ***) Outstanding at the end of 2007 Employee share options granted 2008 **) Exercised in 2008: of 1999 Ordinary share option plan of 2000 Ordinary share option plan of 2001 Ordinary share option plan of 2003 Ordinary share option plan of 2004 Launch share option plan of 2005 Employee share options *) Expired in 2008 Cancelled in 2008 Value adjustment ***) Outstanding at the end of 2008 Average exercise price per option DKK Market value per option DKK Market value DKK million Share options 9,951,772 119 2,229,084 175 95 (27,000) 63 (161,500) (270,400) 99 (280,416) 99 99 (845,880) 166 (283,600) 161 (36,000) 0 (350) 119 (179,306) 64 45 64 64 64 64 64 64 64 64 64 634 99 (2) (10) (17) (18) (54) (18) (2) 0 (11) 519 10,096,404 134 111 1,120 (73,000) (287,434) (306,800) (356,280) (138,680) (21,528) (16,048) (979,010) (840) (17,000) (261,036) 7,638,748 694,500 (140,500) (159,525) (92,700) (225,225) (566,516) (156,380) (58,070) (16,000) 63 99 99 166 99 166 161 98 0 134 134 140 0 99 99 166 97.5 133.5 0 140 140 6,918,332 133 111 111 111 111 111 111 111 111 111 111 111 201 289 201 201 201 201 201 201 201 201 137 (8) (32) (34) (40) (15) (2) (2) (109) 0 (2) (29) 688 1,535 201 (28) (32) (18) (45) (114) (31) (12) (3) (505) 948 *) Granted to employees in some countries outside of Denmark with a benefit equal to the employee share benefit obtained by employees under the employee share programme in the rest of the world. **) Granted to employees outside of DK under the employee share programme, with a benefit equal to the benefit obtained by the Danish based employees under the employee share programme. ***) The market value has been calculated using the Black-Scholes model with the parameters existing at year-end of the respective year. Novo Nordisk Annual Report 2008 79 Consolidated financial statements Notes – Consolidated financial statements 33 Share-based payment schemes (continued) Exercisable and outstanding share options in Novo Nordisk 1999 Ordinary share option plan 2000 Ordinary share option plan 2001 Ordinary share option plan 2003 Ordinary share option plan 2004 Ordinary share option plan 2005 Employee share options *) Issued share options Exercised share options Expired Cancelled Outstanding/ exercisable share options Exercise price DKK 1,375,000 1,526,000 1,369,960 2,185,000 1,618,832 227,080 (1,206,000) (1,216,155) (732,580) (1,204,235) (566,516) (157,570) (16,000) – – – – (18,270) (153,000) (46,504) (86,788) (82,666) (111,000) (51,240) – 263,341 550,592 898,099 941,316 – Exercisable at the end of 2008 8,301,872 (5,083,056) (34,270) (531,198) 2,653,348 2005 Ordinary share option plan 2006 Ordinary share option plan 2008 Employee share option **) 1,640,468 2,229,084 694,500 – – – – – – (141,568) (157,500) – 1,498,900 2,071,584 694,500 Outstanding at the end of 2008 ***) 12,865,924 (5,083,056) (34,270) (830,266) 6,918,332 Exercise period 24/3 2003 – 23/3 2008 22/2 2004 – 21/2 2009 8/2 2005 – 7/2 2010 6/2 2007 – 5/2 2012 31/1 2008 – 30/1 2013 1/11 2008 – 31/12 2008 31/1 2009 – 30/1 2014 31/1 2010 – 30/1 2015 1/11 2011 99 99 166 98 134 – 153 175 – *) Granted to employees in some countries outside of Denmark with a benefit of the 2005 employee share programme equal to the employee share benefit obtained by employees under the employee share programme in the rest of the world. **) Granted to employees outside of DK, with a benefit of the 2008 employee share programme equal to the benefit obtained by the Danish based employees under the employee share programme. ***) All stock options will vest if there is a change of control of Novo Nordisk A/S, cf note 36 Commitments and contingencies. Average market price of Novo Nordisk B shares per trading period in 2008 31 January – 14 February 30 April – 14 May 7 August – 21 August 30 October – 13 November Total exercised options Average market price DKK 318 325 306 308 Exercised share options 709,551 269,660 107,270 254,365 1,340,846 34 Management‘s remuneration, share options and shareholdings For information on the Board of Directors, the members of Executive Management and other members of the Senior Management Board, please refer to pages 46 – 48 of this Annual Report. Fee to the Board of Directors and the Audit Committee In 2008 the base fee for members of the Board of Directors was DKK 400,000 (DKK 400,000 in 2007). DKK million Sten Scheibye (Chairman of the Board) Göran A Ando (Vice chairman of the Board and R&D facilitator) *) Kurt Anker Nielsen (Chairman of the Audit Committee) Jørgen Wedel (Audit committee member) Other Board of Directors/Audit Committee member Total Board of Directors Audit Committee 1.0 0.6 0.4 0.4 2.8 5.2 – – 0.5 0.2 0.1 0.8 2008 Total 1.0 0.6 0.9 0.6 2.9 6.0 Board of Directors Audit Committee 1.0 0.6 0.4 0.4 2.8 5.2 – – 0.5 0.2 0.2 0.9 2007 Total 1.0 0.6 0.9 0.6 3.0 6.1 *) In his capacity as R&D facilitator, Göran A Ando received a fee of DKK 0.3 million in 2008 (DKK 0.3 million in 2007). 80 Novo Nordisk Annual Report 2008 Consolidated financial statements Notes – Consolidated financial statements 34 Management‘s remuneration, share options and shareholdings (continued) Executive Management and other members of Senior Management Board DKK million 2008 Executive Management: Lars Rebien Sørensen Jesper Brandgaard Lise Kingo Kåre Schultz **) Mads Krogsgaard Thomsen Executive Management in total Other members of Senior Management Board in total ***) Joint pool ****) 2007 Executive Management: Lars Rebien Sørensen Jesper Brandgaard Lise Kingo Kåre Schultz **) Mads Krogsgaard Thomsen Executive Management in total Other members of Senior Management Board in total ***) Joint pool ****) Fixed salary Cash bonus *) Pensions Car allowance etc Share-based payment Total remuneration 6.3 3.9 3.5 4.9 3.9 22.5 55.3 6.0 3.5 3.2 5.3 3.5 21.5 48.6 2.1 1.4 1.2 1.8 1.4 7.9 2.1 1.3 1.2 1.5 1.3 7.4 17.1 17.3 2.0 1.2 1.1 1.7 1.2 7.2 2.0 1.2 1.1 1.3 1.2 6.8 17.6 14.9 0.3 0.3 0.3 0.9 0.3 2.1 8.1 0.3 0.3 0.3 1.3 0.3 2.5 7.4 – – – – – – – 54.5 – – – – – – – 42.7 10.8 6.9 6.2 9.1 6.9 39.9 97.8 54.5 10.3 6.2 5.7 9.6 6.2 38.0 88.5 42.7 *) **) Cash bonus disclosed for 2008 is the expected bonus payment in 2009 relating to performance in 2008. The total remuneration in 2007 and 2008 is reflecting costs in relation to Kåre Schultz’ expatriation to Switzerland. Out of the total remuneration approximately 8.9% related to cost compensation and associated tax effects of being expatriated. ***) The total remuneration for 2008 includes remuneration to 26 senior vice presidents of which two resigned during the year. The total remuneration for 2007 includes remuneration to 25 senior vice presidents of which five resigned during the year. ****) The joint pool is locked up for three years before it is transferred to the participants employed at the end of the three-year period. The value is the cash amount of the share bonus granted in the year using the grant date market value of Novo Nordisk B shares. Based on the split of participants at the establishment of the joint pool, approximately 35% of the pool will be allocated to the members of Executive Management and 65% to other members of Senior Management Board (2007: 35% and 65% respectively). In the lock-up period the joint pool may potentially be reduced as a result of lower than planned value creation in subsequent years. The shares allocated to the joint pool for 2005 (232,026 shares) were released to the individual participants following the approval by the Board of Directors on 28 January 2009. Based on the share price at the end of 2008, the value of the released shares is as follows: Value of shares released in 2009 Executive Management: Lars Rebien Sørensen Jesper Brandgaard Lise Kingo Kåre Schultz Mads Krogsgaard Thomsen Executive Management in total Other members of Senior Management Board in total **) *) The market value of the shares released in 2009 is based on Novo Nordisk B share price at the end of 2008 of DKK 271. **) In addition 46,404 shares (market value: DKK 12.6 million) were released to retired members of management. Number Market value *) DKK million of shares 23,208 15,468 15,468 15,468 15,468 85,080 100,542 6.3 4.2 4.2 4.2 4.2 23.1 27.2 The remuneration package for members of the Senior Management Board employed in foreign subsidiaries differs from the general package in respect of other benefit and bonus schemes included in the package in order to ensure an attractive package compared to local conditions. In addition, Executive Management and other members of Senior Management Board receive ordinary allowances in connection with business travelling, conferences and education etc, which are based on reimbursement of actual costs. In the event of termination – whether by Novo Nordisk or by the individual – due to a merger, acquisition or takeover of Novo Nordisk, members of Executive Management are entitled to a severance payment of 36 months’ fixed base salary plus pension contribution. This equals amounts between DKK 14.0 million and DKK 23.8 million. Novo Nordisk Annual Report 2008 81 Consolidated financial statements Notes – Consolidated financial statements 34 Management‘s remuneration, share options and shareholdings (continued) Lars Rebien Sørensen serves as a member of the Board of Directors of ZymoGenetics, Inc. and does not retain the compensation. Lars Rebien Sørensen further- more serves as a member of the Supervisory Board of Bertelsmann AG and retains the remuneration of EUR 55,000 in 2008 (EUR 59,000 in 2007) and as a member of the Supervisory Board of DONG Energy and retains the remuneration of DKK 168,750 in 2008 (DKK 113,000 in 2007). Jesper Brandgaard serves as Chairman of the Board of SimCorp A/S and retains the remuneration of DKK 442,500 in 2008 (DKK 203,000 in 2007). Lise Kingo served as a member of the Board of Directors of GN Store Nord A/S until March 2008 and retained the remuneration of DKK 100,000 (DKK 350,000 in 2007). Kåre Schultz serves as a member of the Board of Directors of Lego A/S and retains the remuneration of DKK 250,000 (DKK 171,000 in 2007). Mads Krogsgaard Thomsen serves as a member of the Board of Directors of Cellartis AB and DTU and retains the remuneration of SEK 50,000 (SEK 25,000 in 2007) from Cellartis AB and DKK 60,000 (DKK 60,000 in 2007) from DTU. At the beginning of the year Exercised during the year Additions during the year At the end Market value *) DKK million of the year 91,000 46,500 20,000 34,500 46,500 1,000 1,000 1,000 34,500 1,000 238,500 38,500 – – – – – – 90,000 45,500 19,000 – 45,500 200,000 Other members of Senior Management Board in total **) 323,900 63,750 16,800 276,950 Total 562,400 102,250 16,800 476,950 *) Calculation of market values at year-end has been based on the Black-Scholes option pricing model applying the assumptions shown in note 33. **) Additions during the year cover the holdings of share options by the Senior Management Board members appointed in 2008. Management’s holding of Novo Nordisk shares The internal rules for board members’, executives’ and certain employees’ trading in Novo Nordisk securities only permit trading in the 15-calendar-day period following each quarterly announcement. At the beginning of the year Addition during the year Sold/released during the year At the end Market value *) DKK million of the year Management’s share options Share options in Novo Nordisk Executive Management: Lars Rebien Sørensen Jesper Brandgaard Lise Kingo Kåre Schultz Mads Krogsgaard Thomsen Executive Management in total Shares in Novo Nordisk Board of Directors: Sten Scheibye Göran A Ando Anne Marie Kverneland Henrik Gürtler Johnny Henriksen Jørgen Wedel Kurt Anker Nielsen Kurt Briner Pamela J Kirby Stig Strøbæk Søren Thuesen Pedersen Board of Directors in total Executive Management: Lars Rebien Sørensen Jesper Brandgaard Lise Kingo Kåre Schultz Mads Krogsgaard Thomsen 800 1,200 3,320 – 660 8,000 62,904 – – 320 120 – – 100 – 100 3,000 42,000 – – 100 465 – – 320 – – – 6,000 – – – – 800 1,200 3,100 – 760 11,000 98,904 – – 420 585 77,324 45,765 6,320 116,769 820 320 120 320 320 27,234 18,526 18,526 52,026 18,526 27,134 18,426 18,426 14,500 18,426 920 420 220 37,846 420 Executive Management in total 1,900 134,838 96,912 39,826 The Senior Management Board in total 23,036 160,824 154,410 29,450 Joint pool for Executive Management and other members of Senior Management Board **) 912,659 171,492 347,827 ***) 736,324 Total 1,014,919 512,919 605,469 922,369 *) Calculation of the market value is based on the quoted share prices of DKK 271 at the end of the year. **) The annual allocation to the joint pool is locked up for three years before it is transferred to the participants employed at the end of each three-year period. Based on the split of participants at the establishment of the joint pool, between 35– 40% of the pool will be allocated to the members of Executive Management and between 60 – 65% to other members of the Senior Management Board. In the lock-up period, the joint pool may potentially be reduced as a result of lower than planned value creation in subsequent years. ***) Includes 94,986 shares currently assigned for five retired members of the management. 82 Novo Nordisk Annual Report 2008 13.3 6.7 3.2 – 6.7 29.9 42.0 71.9 0.2 0.3 0.8 – 0.2 3.0 26.8 – – 0.1 0.2 31.6 0.2 0.1 0.1 10.3 0.1 10.8 8.0 199.5 250.0 Consolidated financial statements Notes – Consolidated financial statements 35 Derivative financial instruments Novo Nordisk uses a number of financial instruments to hedge currency exposure and, in line with the Group’s treasury policies, Novo Nordisk only hedges commercial exposures and consequently does not enter into derivative transactions for trading or speculative purposes. Novo Nordisk’s currency hedging activities are categorised into hedging of forecasted transactions (cash flow hedges), hedging of assets and liabilities (fair value hedges) and hedging of net investments. Hedging of forecasted transactions The table below shows the fair value of cash flow hedging activities for 2008 and 2007 specified by hedging instrument and the major currencies. The fair value of the financial instruments qualifying for hedge accounting under IAS 39 ‘Financial instruments’ is recognised directly under equity until the hedged items are recognised in the Income statement. At year-end a loss of DKK 864 million is deferred via equity (a gain of DKK 691 million in 2007). The fair values of the financial instruments not qualifying for hedge accounting under IAS 39 are recognised directly in the Income statement. Financial instruments hedging forecasted transactions qualifying for hedge accounting under IAS 39 2008 2007 Contract amount at year-end Positive fair values at year-end Negative fair values at year-end Contract amount at year-end Positive fair values at year-end Negative fair values at year-end DKK million Forward contracts, net sales: USD JPY GBP Other Total forward contracts Cross currency and interest rate swaps: EUR / EUR *) EUR / USD *) Total cross currency and interest rate swaps Total hedging of forecasted transactions qualifying for hedge accounting under IAS 39 10,326 3,464 1,027 354 15,171 251 504 755 – – 163 31 194 5 – 5 550 511 – – 1,061 – 2 2 10,043 2,765 840 357 14,005 251 504 755 534 88 34 – 656 17 25 42 15,926 199 1,063 14,760 698 Financial instruments hedging forecasted transactions qualifying for hedge accounting under IAS 39, but for which hedge accounting is not applied Cross currency and interest rate swaps: DKK / DKK EUR / EUR *) EUR / USD *) JPY/ DKK Total hedging of forecasted transactions qualifying for hedge accounting under IAS 39, but for which hedge accounting is not applied *) The contract value is disclosed only in the upper table. 310 – – 314 624 – – – 40 40 15 8 32 – 55 310 – – 314 – – – 101 624 101 Financial instruments hedging forecasted transactions, but not qualifying for hedge accounting under IAS 39 Currency options: EUR / USD (purchased USD put) EUR /JPY (purchased JPY put) Total hedging of forecasted transactions not qualifying for hedge accounting under IAS 39 1,080 – 1,080 17 – 17 – – – 2,498 224 2,722 44 3 47 Total hedging of forecasted transactions 17,630 256 1,118 18,106 846 73 Novo Nordisk Annual Report 2008 83 – – – 7 7 – – – 7 7 8 51 – 66 – – – Consolidated financial statements Notes – Consolidated financial statements 35 Derivative financial instruments (continued) 2008 2007 The financial contracts existing at the end of the year (cash flow hedges) are expected to be recognised in the Income statement within the following number of months: USD JPY GBP The cash flows covered by the above financial contracts are expected to occur within the following number of months: USD JPY GBP 15 months 13 months 13 months 16 months 18 months 13 months 16 months 15 months 10 months 17 months 16 months 13 months The maturity of the swaps existing at the end of 2008 is December 2011 and December 2012 (December 2011 and December 2012 at the end of 2007). Hedging of assets and liabilities The table below shows the fair value of fair value hedging activities for 2008 and 2007 specified by hedging instrument and the major currencies. All changes in fair values are recognised in the Income statement amounting to a loss of DKK 34 million in 2008 (a gain of DKK 221 million in 2007). As the hedges are highly effective the net gain or loss on the hedged items is similar to the net loss or gain on the hedging instruments. DKK million Forward contracts, net sales: USD JPY GBP Other Total forward contracts Total hedging of assets and liabilities 2008 2007 Contract amount at year-end Positive fair values at year-end Negative fair values at year-end Contract amount at year-end Positive fair values at year-end Negative fair values at year-end 1,235 669 326 448 2,678 2,678 2 – 51 56 109 109 – 143 – – 143 143 1,937 679 389 276 3,281 3,281 145 55 22 4 226 226 – – – 5 5 5 The financial contracts existing at the end of the year hedge the currency exposure on assets and liabilities in the Group’s major currencies other than DKK and EUR, that is assets and liabilities in USD, JPY and GBP. 84 Novo Nordisk Annual Report 2008 Consolidated financial statements Notes – Consolidated financial statements 35 Derivative financial instruments (continued) Hedging of net investments in foreign subsidiaries The table below shows the fair value of hedging activities relating to net investments in foreign subsidiaries for 2008 and 2007 specified by hedging instrument and the major currencies. All changes in fair values relating to currency are recognised directly under equity, amounting to a loss of DKK 18 million in 2008 (an income of DKK 9 million in 2007). All changes relating to interest rates are recognised in the Income statement, amounting to DKK 1 million in 2008 (DKK 1 million in 2007). DKK million Cross currency swaps: JPY/ DKK Total hedging of net investments in foreign subsidiaries 2008 2007 Contract amount at year-end Positive fair values at year-end Negative fair values at year-end Contract amount at year-end Positive fair values at year-end Negative fair values at year-end 100 100 – – 18 18 100 100 9 9 – – The maturity of the swap existing at the end of 2008 is October 2009 (October 2009 at the end of 2007). The financial contracts existing at the end of the year hedge the following share of the major net investments: DKK million USD JPY GBP EUR *) Other Total 2008 2007 Net investment % covered Net investment % covered 2,423 1,013 153 4,301 3,782 11,672 0% 12% 0% 0% 0% 2,017 746 204 10,238 3,746 16,951 0% 12% 0% 0% 0% *) Including subsidiaries with EUR as functional currency regardless of the local currency in the subsidiary. Total hedging activities The table below summarises the fair values of all the hedging activities of Novo Nordisk. DKK million Currency-related instruments: Forward contracts Currency options Cross currency swaps Total currency-related instruments Interest-related instruments: Interest rate swaps Total interest-related instruments Financial instruments with both positive and negative fair values recognised net in the balance Total derivative financial instruments included in marketable securities and in short-term debt The fair values at year-end are recognised in: Income statement Equity: – Cash flow hedges – Equity swaps (included in exchange rate adjustment of investments in subsidiaries) Total fair values 2008 2007 Contract amount at year-end Positive fair values at year-end Negative fair values at year-end Contract amount at year-end Positive fair values at year-end Negative fair values at year-end 17,849 1,080 918 19,847 561 561 303 17 40 360 5 5 1,204 – 52 1,256 23 23 17,286 2,722 918 20,926 561 561 882 47 143 1,072 9 9 20,408 365 1,279 21,487 1,081 12 – 59 71 7 7 78 – – – – (33) (33) 20,408 365 1,279 21,487 1,048 166 199 – 365 198 1,063 18 1,279 374 698 9 1,081 45 71 7 – 78 Novo Nordisk Annual Report 2008 85 Consolidated financial statements Notes – Consolidated financial statements 2008 2007 Contingencies 36 Commitments and contingencies DKK million Commitments Operating lease commitments The operating lease commitments below are related to non-cancellable operating leases primarily related to premises, company cars and office equipment. Approximately 55% of the commitments are related to leases outside Denmark. The lease costs for 2008 and 2007 were DKK 951 million and DKK 886 million respectively. Lease commitments expiring within the following periods as from the balance sheet date: Within one year Between one and two years Between two and three years Between three and four years Between four and five years After five years 869 788 412 298 280 870 728 609 445 355 312 719 Total 3,517 3,168 Purchase obligations 2,093 2,018 The purchase obligations primarily relate to con - tractual obligations to investments in property, plant and equipment as well as purchase agreements regarding medical equipment and consumer goods. Novo Nordisk expects to fund these commitments with existing cash and cash flows from operations. Obligations relating to research and development projects 764 2,471 Novo Nordisk has engaged in research and develop- ment projects with a number of external corpora- tions. The major part of the obligations comprises fees on the liraglutide programme. Other guarantees 412 347 Other guarantees primarily relate to guarantees issued by Novo Nordisk in relation to rented property. Security for debt 1,401 2,166 Land, buildings and equipment etc at carrying amount. World Diabetes Foundation At the Annual General Meeting of Novo Nordisk A/S in 2002 the shareholders agreed on a donation to the World Diabetes Foundation, obligating Novo Nordisk A/S for a period of 10 years from 2001 to make annual donations to the Foundation of 0.25% of the net insulin sales of the Group in the preceding financial year. At the Annual General Meeting in 2008 a new donation in supplement to the existing obligation was agreed by the shareholders. According to the new donation, Novo Nordisk is obliged to make annual donations to the foundation of 0.01% in the period 2008 –2010 and 0.125% in the period 2011–2017 of the net insulin sales of the Group in the preceding financial year. However, annual donations from 2008 –2010 shall not exceed the lower of DKK 70 million or 15% of the taxable income of Novo Nordisk A/S in the financial year in question and from the period 2011 to 2017 the lower of DKK 80 million or 15% of the taxable income of Novo Nordisk A/S in the financial year in question. The donation of DKK 68 million in 2008 is recognised in the Income state- ment. 86 Novo Nordisk Annual Report 2008 See note 3 for the principles for making accounting estimates and judgments about pending and potential future litigation outcomes. Pending litigation against Novo Nordisk As of January 26, 2009 Novo Nordisk Inc., along with a majority of the hormone therapy product manufacturers in the US, is a defendant in product liability lawsuits related to hormone therapy products. These lawsuits cur - rently involve a total of 50 individuals (as compared to 45 individuals in January 2008) who allege to have used a Novo Nordisk hormone therapy product. These products (Activella ® and Vagifem ®) have been sold and marketed in the US since 2000. Until July 2003, the products were sold and marketed exclusively in the US by Pharmacia & Upjohn Company (now Pfizer Inc.). According to information received from Pfizer, 51 individuals (as com- pared to 27 individuals in January 2008) currently allege, in relation to similar lawsuits against Pfizer Inc, that they also have used a Novo Nordisk hormone therapy product. Novo Nordisk does not have any court trials scheduled for 2009 and does not presently expect to have a trial scheduled before Q3 2009. Novo Nordisk does not expect the pending claims to have a material impact on Novo Nordisk’s financial position. In November 2006, Novo Nordisk A/S and its Italian affiliate Novo Nordisk Farmaceutici s.p.a were sued by A. Menarini Industrie Farmaceutiche Riunite s.r.l. and Laboratori Guidotti s.p.a. (‘Menarini’) in the Civil Court in Rome. Menarini alleges that Novo Nordisk breached an alleged contract with Menarini for the sale and distribution of insulin and insulin analogues in the Italian market or, in the alternative, has incurred a pre-contractual or extra contractual liability arising from negotiations between the parties. Novo Nordisk disputes the claims made by Menarini. A hearing in the matter is scheduled to take place on September 29, 2009. Novo Nordisk cannot predict how long the litigation will take or when it will be able to provide additional information. At this point in time, Novo Nordisk does not expect the pending claim to have a material impact on Novo Nordisk’s financial position. Novo Nordisk Inc is currently a defendant in four separate cases filed in the US alleging that Novo Nordisk and a number of other pharmaceutical com - panies provided a false Average Wholesale Price for certain drugs covered by Medicaid. These cases have been brought by the State of Alabama, and the counties of Oswego, Erie, and Schenectady, New York. Novo Nordisk was dismissed from a similar action brought by the State of Mississippi. Further, in 2005, Novo Nordisk was dismissed in 38 similar cases brought by counties in the State of New York. Novo Nordisk does not expect the pending claims to have a material impact on Novo Nordisk’s financial position. Pending claims against Novo Nordisk and investigations involving Novo Nordisk In December 2005, the office of the US Attorney for the Eastern District of New York served Novo Nordisk with a subpoena calling for the production of documents relating to the company’s US marketing and promotional practices. The company believes that the investigation is limited to its insulin products. The subpoena indicates that the documents are necessary for the investigation of potential criminal offences relating to healthcare benefit programmes. Novo Nordisk is cooperating with the US Attorney in this investigation. At this point in time, Novo Nordisk cannot determine or predict the outcome of the investigation. In addition, Novo Nordisk cannot predict how long the investigation will take or when the company will be able to provide additional information. In February 2006, Novo Nordisk received a subpoena from the US Securities and Exchange Commission (SEC) calling for Novo Nordisk to produce documents relating to the United Nations Oil-for-Food Programme. Other companies have disclosed that they have received similar subpoenas. Novo Nordisk has been discussing the matter with the SEC and the US Department of Justice, and has fully cooperated with the US authorities. Further, since 21 September 2006, the Danish Prosecutor has investigated the possibility of disgorging profits earned under the Programme. Novo Nordisk can neither determine or predict the outcome of these investigations, nor predict how long they will take. At this point in time, Novo Nordisk does not expect the pending claim to have a material impact on Novo Nordisk’s financial position. Consolidated financial statements Notes – Consolidated financial statements 36 Commitments and contingencies (continued) Other litigation proceedings In addition to the above, the Novo Nordisk Group is engaged in certain litigation proceedings. In the opinion of management, settlement or continuation of these proceedings are not expected to have a material effect on the financial position. Liability for the debts and obligations of Novozymes following the demerger of Novozymes in 2000 Novo Nordisk A/S and Novozymes A/S are subject to joint and several liability for any obligation which existed at the time of the announcement of the demerger in 2000. At the end of the year the remaining part of the joint and several liability in Novozymes A/S amounted to DKK 557 million (DKK 557 million in 2007). Debts and obligations pertaining to the period before 1 January 2000, which are recognised after 1 January 2000 and which cannot be clearly attributed to either Novo Nordisk A/S or Novozymes A/S, will be distributed proportionally between the two companies according to an agreement established in con- nection with the demerger in November 2000. Disclosure regarding Change of Control The EU Take-Over Directive, as partially implemented by the Danish Financial Statements Act contains certain rules relating to listed companies on disclosure of information that may be of interest to the market and potential takeover bidders, in particular in relation to disclosure of change of control provisions. For information on the ownership structure of Novo Nordisk, please see ‘Shares and capital structure’ on pages 49 – 50. For information on change of control clauses in share option programmes please see pages 78 – 80 with note 33 ‘Share-based payment schemes’, and in relation to employment contracts of Executive Management of Novo Nordisk, please see note 34 ’Management’s remuneration, share options and shareholdings’ on pages 80 – 82. In addition, Novo Nordisk discloses that the company has significant agree- ments to which the company is a party and which take effect, alter or terminate upon a change of control of the company following implementa- tion of a takeover bid. If effected, a takeover could – at the discretion of each relevant counterparty – lead to the termination of one or more of such agreements and a total loss of approximately 5% of Novo Nordisk’s turn over, corresponding to approximately 4% of Novo Nordisk‘s gross profit. Novo Nordisk Annual Report 2008 87 Consolidated financial statements Notes – Consolidated financial statements Financial definitions ADRs American Depositary Receipts. Gross margin Gross profit as a percentage of sales. Basic earnings per share (EPS) Net profit divided by the average number of shares outstanding. Net profit margin Net profit as a percentage of sales. Cash to earnings Free cash flow as a percentage of net profit. Diluted earnings per share Net profit divided by the sum of average number of shares outstanding including the dilutive effect of share options ‘in the money’ in accordance with IAS 33. The dilutive effect of share options ‘in the money’ is calculated as the difference between the following: 1) the number of shares that could have been acquired at fair value with proceeds from the exercise of the share options, and 2) the number of shares that would have been issued assuming the exercise of the share options. The difference (the dilutive effect) is added to the denominator as an issue of shares for no consideration. Effective tax rate Income taxes as a percentage of profit before income taxes. Equity ratio Equity at year-end as a percentage of the sum of total liabilities and equity at year-end. Free cash flow The sum of Cash flow from operating activities and Cash flow from investing activities excluding Net changes in marketable securities. Number of shares outstanding The number of shares outstanding is the total number of shares excluding the holding of treasury shares. Operating profit Earnings before tax, financial items and share of profit/loss in associated companies. Operating profit margin Operating profit as a percentage of sales. Payout ratio Total dividends for the year as a percentage of net profit. ROIC (return on invested capital) Operating profit after tax (using the effective tax rate) as a percentage of average inventories, receivables, property, plant and equipment as well as intangible assets less non-interest-bearing liabilities including provisions (the sum of the above assets and liabilities at the beginning of the year and at year-end divided by two). 88 Novo Nordisk Annual Report 2008 Consolidated non-financial statements Overview of non-financial reporting Assurance provider’s recommendations An important element of the assurance process is the disclosure of recom- mendations from the assurance provider. In years when there have been recommendations, Novo Nordisk has disclosed these in the online report. In 2007 and 2008, the assurance provider had no significant recommenda- tions for Novo Nordisk. Global standards Novo Nordisk’s non-financial reporting follows the accountability standard, the AA1000 Framework. It states that reporting must provide a complete, accurate, relevant and balanced picture of the organisation’s approach to and impact on society. In addition, Novo Nordisk’s assurance process is designed according to the AA1000AS (2003). In October 2008, AccountAbility launched a new version of the AA1000AS (2008). Novo Nordisk will in 2009 decide the timeline for implementing the new assurance standard. In 2007, Novo Nordisk upgraded its reporting against the Global Reporting Initiative’s (GRI’s) Sustainability Reporting Guidelines from the 2002 version to the G3. Reporting on management approaches and performance against the list of indicators covering economic, environment, labour practices, human rights, society and product responsibility can be found at annualreport2008.novonordisk.com. Novo Nordisk reports on the GRI G3 because it is the only internationally recognised set of indicators. By reporting on the indicators, it is possible for stakeholders to compare Novo Nordisk’s performance to other organisations’ performance. As a signatory to the UN Global Compact, a platform to promote good corporate principles and learning in the areas of human rights, labour, environment and anticorruption, Novo Nordisk reports on actions during 2008 to implement its 10 principles in the Communication on Progress (CoP). With the new legislation in Denmark, effective as of 1 January 2009, Novo Nordisk will be required to account for the company’s activities on social responsibility, reporting on business strategies and activities on human rights, labour standards, environment and anticorruption. Companies that subscribe to the UN Global Compact and annually submit their CoP will be in com - pliance with the new legislation, provided that the annual report includes a reference to where the CoP has been made publicly available. Novo Nordisk’s CoP 2008 can be found at annualreport2008.novonordisk.com or at UN Global Compact’s website at unglobalcompact.org/COP. This is the fifth year that Novo Nordisk reports on the company’s financial and non-financial performance in one, inclusive document, the Annual Report. Novo Nordisk continues the process to drive integration of the financial and non-financial perspectives to business and seeks to reflect this in the approach to reporting. In the absence of global standards for inclusive reporting, this approach takes its point of departure in current standards for mandatory, financial reporting and current guidelines for voluntary, non-financial report- ing. The aim is to drive business performance and enhance shareholder value by exploring the interactions between financial and non-financial objectives. This entails alignment of key priorities, target setting and definition of key performance indicators, in consultations that involve internal and external stakeholders. The annual report is prepared in respect of current best practice and the principles of materiality, completeness and responsiveness. Stakeholder engage ment informs the process, which also incorporates independent expert reviews of the company’s annual reporting. The selection of information included in the annual reporting reflects evolving priorities in re- sponse to business and societal challenges. In 2008, Novo Nordisk embarked on a process on structuring the control environment of non-financial reporting. The aspiration of this work is to achieve full alignment with the control environment of the financial reporting. Defining materiality Ongoing stakeholder engagement and trendspotting help identify new issues which are or could become material to Novo Nordisk. The Novo Nordisk learning curve is a tool that aligns the process of defining materiality with integration into business practices. Emerging issues that are identified as relevant and potentially material are included at the bottom of the learning curve. Following a review of its implications for Novo Nordisk’s long-term business, a strategy is framed for those issues that are deemed material and subsequently data, indicators and targets are identified. Once management of the issue has been embedded in the organisation, so that it is fully inte - grated into business processes, the strategy will be revisited as appropriate. Moreover, issues that are included on the learning curve are monitored as part of the integrated risk management process. It is Novo Nordisk’s responsibility to ensure that those areas are addressed in which the company has significant impact or where it has a responsibility and ability to act. Novo Nordisk has sought inspiration in AccountAbility’s materiality test to define what is material to Novo Nordisk, what should be included in the annual report and on which grounds topics should be excluded. Applying the materiality test as a tool, sustainability-related issues are prioritised to be reported either in the printed annual report (most material; business critical), online (material, often to specific stakeholder interests) or not reported (not material). The same process applies for the assurance provider’s recommendations. The outcomes of formal reviews, research, stakeholder engagement and inter nal materiality discussions are presented as a proposal for the annual reporting to Executive Management and the Board of Directors, and sub - sequently approved. In addition, Novo Nordisk’s external assurance provider is requested to assure whether the non-financial performance included in the annual report covers the material aspects. The conclusion is available in the Independent Assurance Report on Non-financial Reporting 2008. Read more about how Novo Nordisk defines materiality at annualreport2008.novonordisk.com. Novo Nordisk Annual Report 2008 89 Consolidated non-financial statements Non-financial indicators and targets Non-financial indicators and targets Novo Nordisk is committed to continuous improvement in the company’s environmental, social and economic performance. Setting ambitious objectives and targets and reporting on progress in meeting these targets are core elements of the Novo Nordisk Way of Management. Against this govern - ance framework, targets are set to provide direction and impetus for moving forward. The table shows the extent to which targets were met in 2008 in terms of non-financial performance. This set of top-level Triple Bottom Line targets and indicators links into Novo Nordisk’s Balanced Scorecard, which also focuses on sustainable development. In addition to the non-financial performance targets, process targets are identified. Strategy area Indicator Target Note 2008 2007 2006 Environment Emissions to air CO2 emissions EIR Water EIR Water Diabetes care EIR Water Biopharmaceuticals EIR Energy EIR Energy Diabetes care EIREnergy Biopharmaceuticals Compliance Breaches of regulatory limit values Accidental releases 10% reduction by 2014 compared to 2004 10% reduction by 2010 compared to 2005 10% reduction by 2010 compared to 2005 10% reduction by 2010 compared to 2005 10% reduction by 2010 compared to 2005 50% reduction by 2010 compared to 2005 50% reduction by 2010 compared to 2005 Social Living our values Importance of social and environmental issues for the future of the company Maintain a level of 3.5 or above up to 2014 Managers’ behaviour consistent with Novo Nordisk’s values Maintain a level of 3.5 or above up to 2014 Fulfilment of action points from facilitations of the NNWoM Maintain a level of 80% or above up to 2014 People Engaging culture (employee engagement) Maintain a level of 4.0 or above up to 2014 Opportunity to use and develop employee competences/skills Maintain a level of 3.5 or above up to 2014 People from diverse backgrounds have equal opportunities Maintain a level of 3.5 or above up to 2014 Health & safety Frequency of occupational injuries Continuous decrease Fatalities 0 Access to health LDCs where Novo Nordisk operates Best possible pricing scheme in all LDCs LDCs where Novo Nordisk sells insulin at or below the policy price Best possible pricing scheme in all LDCs Business ethics Employees in sales and marketing trained in business ethics 90% by 2008 Company reputation Improve (or maintain) company reputation with external key stakeholders Improve (or maintain) brand score Quality Number of warning letters and re-inspections 0 The consolidated non-financial statements on pp 93–99 present and discuss performance during 2008. 1 2 2 2 2 3 3 7 7 7 8 8 8 9 9 10 10 11 12 13 2% 12% 9% (32%) (10%) (4%) (50%) (45%) (36%) (24%) (2%) 5% (34%) (28%) (17%) (84%) (87%) (29%) (13%) 1% 30% 4.5 4.3 4.4 4.2 4.3 4.1 99% 99% 99% 4.2 4.1 4.1 5.4 0 36 32 4.1 4.0 4.0 5.9 0 38 36 99% 95% 4.0 3.9 3.9 6.2 0 35 34 NA 72.4 74.0 73.8 0 0 0 90 Novo Nordisk Annual Report 2008 Consolidated non-financial statements Notes – Accounting policies for non-financial data Accounting policies for non-financial data In 2008, there were no significant changes to the accounting policies for non-financial data. The following changes have been made to the basis for the non-financial data compared to 2007: • The production site in Algeria has initiated production of approved products for the market. The environmental impact has therefore been included in the corporate numbers. The production site was ISO14001 certified in 2008. • The accounting policy for the indicator ‘Fulfilment of action points planned arising from facilitations of the Novo Nordisk Way of Management’ has been specified. The specification has not resulted in changes to the scope of performance reported. • Three new accounting policies have been added for the indicators ‘Business ethics’, ‘Company reputation’ and ‘Quality’. All three indicators were reported on page 90 in Novo Nordisk’s Annual Report 2007. There have been no changes to the scope of performance reported. To Novo Nordisk, the AA1000AS (2003) is an essential component in creating a generally applicable approach to assessing and strengthening the credibility of the company’s public reporting of non-financial data. Novo Nordisk’s assurance process has been designed to ensure that the qualitative and quantitative data that document sustainability performance plus the systems that underpin the data and performance are assured. The principles outlined by the AA1000AS (2003) have been applied as described below. 1. Completeness As a pharmaceutical company with global reach, Novo Nordisk is engaged in a range of activities to support sustainable development. All of these are founded on the company’s corporate governance framework, the Novo Nordisk Way of Management. The annual report aims to capture the organisation’s ‘footprint’ in terms of environmental, social and economic impacts on society. Hence, performance is accounted for in relation to targets, major achievements and key issues. The report does not provide full coverage of all the company’s non-financial activities, as it focuses on the material issues. A full coverage of the company’s non-financial activities can be found at annualreport2008.novonordisk.com. See scope of the report below. 2. Materiality Key issues are identified through ongoing stakeholder engagement and addressed by programmes or action plans with clear and measurable targets. Stretch targets are set to guide the long-term efforts in strategic areas, such as global access to health. The issues presented in the annual report are deemed to have a significant impact on the company’s future business per- formance and may support stakeholders in their decision-making and are therefore regarded as Novo Nordisk’s material issues. 3. Responsiveness The report reaches out to a wide range of stakeholders, each with their specific needs and interests. To most stakeholders, however, the annual report is just one single element of interaction and communication with the company. The annual report reflects how the company has addressed stake- holder concerns and interests in dealing with the dilemmas and issues. Stakeholder dialogue is an invaluable part of Novo Nordisk’s efforts as a re- sponsible business, and readers are encouraged to give their feedback. SCOPE Accounting policies for the non-financial data in the annual report are based on data for Novo Nordisk A/S, including NNIT A/S, NNE Pharmaplan A/S and subsidiaries. Environmental data covers the significant environmental impact of the organisation’s activities at the production sites, which produce ap- proved products for the market – 14 in total. One production site was added in 2008 – see above. Social data covers all employees. Economic data covers the Novo Nordisk Group. Engagements in joint ventures and contract licensees are not included in the report scope. However, data for animal testing includes testing taking place at contract research organisations. DATA To ensure consistency of data, all data has been defined and described in company guidelines. Internal control procedures have been established to ensure that data is reported according to the definitions. Environmental data The environmental data covers those activities which, based on an overall environmental assessment, could have a significant impact on the environ- ment. Emissions to air • Emissions of CO2 from energy (total) are based on standard factors for fuel and for energy on a three-year average of available emission factors from the external suppliers of energy. Hence, emission factors for 2008 are the three-year average of 2005 to 2007. The emissions are calculated according to the GHG protocol. • Organic solvents cover the sum of emissions of different types of organic solvent such as acetone, ethanol etc, and exclude emissions of ozone - depleting substances. Data is based on measurement and calculations. Eco Intensity Ratios (EIRs) for water and energy • Environmental performance relative to production size is monitored by the production-related KPI Eco Intensity Ratio – in short EIR – defined as: ‘EIR = Resource consumption per produced or released unit’ By using the performance indicator ‘EIR’, the total performance, measured for water and energy, of a production facility or a business area can be calculated by adding the EIR ratios in standard units from each process step or intermediary product in the process flow from, for example, fermenta- tion to packaging of the finished product. The consolidation of the EIR does not account for spills, changes in stock and production of intermedia prod- ucts for external clients. Compliance • Compliance data consists of breaches of regulatory limits and accidental releases. Data is based on information from departments and test results. All breaches and accidental releases are reported to the authorities. Resources • Water consumption includes consumption of drinking water, industrial water and steam. Data is based on meter readings and checked against invoices. • Energy consumption (direct and indirect supply) includes both direct supply of energy (internally produced energy), for example natural gas, fuel oil and other types, and indirect supply of external energy (externally produced energy), for example electricity, steam and district heat. The consumption of fuel and externally produced energy is based on meter readings and invoices. • Raw materials and packaging materials comprise materials for production and related processes and packaging of products. Consumption of raw materials and packaging is converted to tons. Data is based on registrations in Novo Nordisk’s stock system. Wastewater • Quantities of components such as COD, nitrogen and phosphorus are calculated based on test results or standard factors. Waste • Total waste is the sum of non-hazardous and hazardous waste. The disposal of waste is registered based on weight receipts. • The recycling percentage is calculated as the proportion of waste recycled of the total waste. Waste for recycling can be both non-hazardous and hazardous. The remaining part of the hazardous waste is waste for special treatment. Novo Nordisk Annual Report 2008 91 Consolidated non-financial statements Notes – Accounting policies for non-financial data Accounting policies for non-financial data (continued) Social data The social data covers all employees included in Novo Nordisk’s headcount. Living our values • Average of respondents’ answers as to whether ‘social and environmental issues are important for the future of the company’ and whether ‘my manager’s behaviour is consistent with the Novo Nordisk values’ is based on employee feedback on the questions in the employee survey database eVoice. The average is a simple average calculated in the database of answers given by the employees. • The estimated number of people with diabetes trained or treated includes people with diabetes targeted with training, awareness or treatment. The estimated number is based on registrations by subsidiaries and corporate functions in Novo Nordisk in the Best Practice Database of the activities conducted within various National Changing Diabetes ® programmes. The indicator covers all types of activities, hence it encompasses people with diabetes directly treated and trained in LDCs, in developing and developed countries. The number covers the total number Novo Nordisk has engaged with since the National Changing Diabetes ® programmes were initiated in 2002. • The percentage of fulfilment of action points arising from facilitations of the Novo Nordisk Way of Management is calculated as the number of actions closed during the calendar year divided by the number of actions that should have been closed within the year according to agreed dead- lines. People • All basic employee statistics are based on registrations in the company’s SAP Human Resource system. The number of employees is calculated as the actual number of employees at year-end. • Rate of absence: For employees in Denmark excluding FeF Chemicals, absence data is registered in the SAP Human Resource system. For employees outside Denmark, data for rate of absence is based on local registrations. Types of absence include absence due to the employee’s own illness, pregnancy-related sick leave, and occupational injuries and illnesses per total available working days in the year adjusted for national holidays. • Rate of employee turnover: The rate of employee turnover is calculated as Business ethics • Employees in sales and marketing trained in business ethics covers employees who have participated in national or regional level training sessions for Novo Nordisk’s business ethics policy and procedures. Company reputation • Company reputation is measured by a mean brand score in four core markets (China, Germany, UK, US) by an independent external consultancy firm. The mean brand score is based on company ratings collected through individual interviews, conducted with primary and secondary care profes- sionals (target groups). The mean brand score is benchmarked against main competitors. Quality • The number covers warning letters issued by the FDA in connection with GMP, GCP or GLP inspections and the number of re-inspections issued to Novo Nordisk by any health authority globally. Warning letters and re-inspections are recorded by Global Quality. Warning letters from the FDA regarding pro motional materials are not included. the number of employees who left Novo Nordisk during the year compared to the average number of employees in the year. Training costs • Training costs are all costs recorded in a specific account in the financial • Average of respondents’ answers to 10 selected questions related to employees’ engagement in Novo Nordisk in the employee survey database eVoice. The average is a simple average calculated in the database of answers given by the employees. • Average of respondents’ answers as to whether ‘their work gives them an opportunity to use and develop their competences and skills’ and whether ‘people from diverse backgrounds have equal opportunities’ is based on employee feedback on the questions in the employee survey database eVoice. The average is a simple average calculated in the database of answers given by the employees. Health & safety • The frequency of occupational injuries is the number of injuries reported for all employees per million working hours. An occupational injury is any work-related injury causing at least one day of absence in addition to the day of the injury. accounts. The amount covers internal and external training posted in the financial accounts. Patent families • Patent families are the ‘number of active patent families to date’ and the ‘new patent families (first filing)’. Animals • Animals purchased for testing are the number of animals purchased for all testing undertaken for Novo Nordisk either in-house or at Contract Research Organisations (CROs). The number of animals purchased is based on internal registration of purchased animals and yearly reports from CROs. Economic data The economic indicators are based on data from the consolidated financial statements. See financial definitions. R&D • R&D costs, investments and sales are based on Novo Nordisk’s consolidated • The number of fatalities is based on registrations centrally and locally in financial statements. subsidiaries. Access to health • Novo Nordisk has formulated a pricing policy for the Least Developed Countries (LDCs). The purpose of the policy is to offer insulin to the world’s LDCs at or below a price of 20% of the average prices for insulin in the Western world. The Western world is defined as Europe (EU, Switzerland, Norway), the United States, Canada and Japan. • The term ‘operates in’ does not denote actual physical presence by Novo Nordisk. It is defined as direct or indirect sales by Novo Nordisk via govern- ment tender or private market sales to wholesalers, distributors, NGOs etc. • The estimated number of healthcare professionals trained or educated includes healthcare professionals directly trained, educated, interacted with or reached through awareness campaigns. The estimated number is based on registrations by subsidiaries and corporate functions in Novo Nordisk in the Best Practice Database of the activities conducted within various National Changing Diabetes ® programmes. The number covers the total number Novo Nordisk has engaged with since the National Changing Diabetes ® programmes were initiated in 2002. Remuneration • The cash value distribution is based on Novo Nordisk’s consolidated finan- cial statements. Corporate tax • All types of tax reported are based on registrations of taxes paid in Denmark, except corporate tax as a share of sales. Employment • Direct and indirect effects on the number of jobs, job income and income tax are calculated using financial registrations and general statistics from public sources such as Statistics Denmark, Updated Economic Multipliers for the US Economy 2003 (Economic Policy Institute) and China Statistical Yearbook. The indicators are an estimate of the effects created by Novo Nordisk in Denmark and globally. Exports • Novo Nordisk exports as a share of Danish exports are based on ‘Finans - ministeriets Økonomiske Redegørelse’. All data is documented and evidence has been submitted to the assurance provider. 92 Novo Nordisk Annual Report 2008 Consolidated non-financial statements Notes – Performance indicators Environment 1 Emissions to air Novo Nordisk’s total energy consumption decreased by 9% in 2008, which translates into a similar 9% decrease in the energy-related emissions of CO2 from 236,000 tons in 2007 to 215,000 tons in 2008. The decrease in CO2 was primarily due to decreased emissions from the production site in Kalundborg in Denmark as a result of changes in production, process optimisations as well as realisation of energy-saving projects. The annual CO2 emission is now close to the 2004 (210,000 tons) baseline year, only 2% above, and Novo Nordisk is con fident that the ambitious 10% absolute reduction target will be met in 2014. As planned, this will happen through a continued effort in the cLEAN ® programme and secondly, the highly prioritised energy-saving CO2 Organic solvents programme. This energy-saving programme has until now resulted in an estimated 20,000 ton reduction in CO2 emissions. Thirdly, green electricity from the offshore wind farm at Horns Rev II in Denmark will give substantial reductions, starting in the end of 2009. Emissions to air of organic solvents increased from 81 tons in 2007 to 93 tons in 2008, an increase of 15%, which was primarily due to increase in emissions of acetone and isopropanol. The organic solvents consist of ethanol (68%), isopropanol (16%) and acetone (16%). Unit 1,000 tons Tons 2008 2007 2006 215 93 236 81 229 102 2 Eco Intensity Ratios (EIR) EIR is reported for the two business areas Diabetes care and Biopharma - ceuticals. The long-term EIR target for 2006 –2010 is a 2% reduction in water and energy consumption relative to production on average per year, which corresponds to a reduction of 10% for all four EIR indicators. To get the best foundation for the EIR, the target is based on a bottom-up process where pro- duction has given its best estimates for water and energy consumption and related these to the forecasted production. The EIR targets are implemented in the Balanced Score card for Novo Nordisk. In 2008, the EIR Water and EIR Energy improved for both Diabetes care and Bio pharma ceuticals. The EIR for water was improved by 25% for Diabetes care and by 10% for Biopharmaceuticals. Likewise, the EIR for energy improved by 22% and 8% for Diabetes care and Biopharma ceuticals respectively. EIR Water Diabetes care Biopharmaceuticals EIREnergy Diabetes care Biopharmaceuticals 3 Compliance Ensuring compliance with legal environmental requirements is a high priority for Novo Nordisk. Preventive measures are beginning to show results as expected. However, the number of breaches of regulatory limit values in- creased from 22 in 2007 to 28 in 2008, an increase of 27%. The main reason being that 21 out of the 28 breaches were related to pH and temperature of wastewater. Compared to last year this is an increase of 31% due to changes in the wastewater treatment. Focus will be increased on pH and temperature in wastewater in 2009. In the same period, the number of accidental releases decreased by 13% to a total of 91, of which 66 were releases of cooling agents such as HCFCs, HFCs and ammonia. This decreasing number reflects parti cular efforts focused on cooling equipment, which were initiated in 2007 and intensified in 2008. This focus has resulted in improved knowledge of what causes the releases, and hence which preventive actions to implement. Breaches of regulatory limit values – related to pH and temperature of wastewater Accidental releases – releases of cooling agents Unit m3/ MU m3/g API GJ/ MU GJ/g API 2008 2007 2006 5.5 3.7 4.0 7.3 7.3 4.1 5.1 7.9 7.8 4.8 5.5 9.2 There were no accidental releases of GMOs in 2008. All incidents have been reported to the authorities. Novo Nordisk has, together with the authorities, assessed that breaches of regulatory limit values and accidental releases have had no or only a minor impact on the external environment. The 2010 target of a 50% reduction in the number of breaches of regulatory limit values is progressing according to plan with an 84% reduction so far. The long-term target of avoiding breaches of regulatory limit values and accidental releases altogether has, however, not yet been met. Preventive measures are long-term efforts, consisting of training of key employees, risk assessment of production sites and technical solutions to mitigate these risks. In 2009 and the following years, there will be continued focus on compliance and preventive measures, which can further reduce the number of breaches and help curb the curve of accidental releases. Unit Number Number Number Number 2008 2007 2006 28 21 91 66 22 16 105 82 123 119 135 82 Novo Nordisk Annual Report 2008 93 Consolidated non-financial statements Notes – Performance indicators Environment (continued) 4 Resources The consumption of water and energy both decreased from 2007 to 2008. Energy decreased by 9% and water consumption by 17%. The decrease is partly due to changes in production at the production facility in Kalundborg, Denmark, the cLEAN ® programme as well as realisation of energy- and water-saving projects. The performance is as expected. Water consumption Energy consumption Raw materials and packaging materials The consumption of materials decreased by 13%. This decrease is as expected and was mainly due to production optimisation at site Kalundborg in Denmark. Unit 1,000 m3 1,000 GJ 1,000 tons 2008 2,684 2,533 132 2007 3,231 2,784 152 2006 2,995 2,712 142 5 Wastewater The total volume of wastewater decreased by 8% from 2007 to 2008 as expected. In the same period, the discharged quantity of COD increased from 813 tons to 891 tons, corresponding to a 10% increase primarily due to an extraordinary discharge of ethanol and glucose from a pilot plant in Bagsværd in Denmark. The quantity of nitrogen decreased from 107 tons to 95 tons, corresponding to a 11% decrease as expected. The discharged quantity of phosphorus increased from 14 tons to 15 tons, corresponding to an increase of 7% primarily due to changes in production at site Chartres in France. COD Nitrogen Phosphorus Unit Tons Tons Tons 2008 2007 891 95 15 813 107 14 2006 1,000 107 19 6 Waste In 2008, there was an increase in the total waste of 16% compared to 2007. This was due to a 2% increase in the quantity of hazardous waste and a 23% increase in the quantity of non-hazardous waste. The recycling percentage in- creased to 51%, from 38% in 2007. The 2% increase in hazardous waste was mainly due to an increase in contaminated soil and organic compounds. The relative amounts of ethanol waste and medicine waste were reduced. The increase in non-hazardous waste can be explained by an increase in quantity of gland residue and quantity of wastewater. The wastewater is sent for special treatment at a hazardous waste treatment facility for precautionary reasons. There was a decrease in non-hazardous waste for incineration and landfill. Total waste – Non-hazardous waste Recycled Incinerated *) Landfill Special treatment – Hazardous waste Recycled ethanol **) Incinerated ethanol ***) Recycling percentage Unit Tons Tons % % % % Tons % % % 2008 2007 2006 20,346 14,240 57 20 6 17 6,106 38 19 51 17,576 11,604 48 26 13 13 5,972 18 40 38 24,165 10,594 39 33 10 18 13,571 17 48 35 *) 99.6% with energy recovery (in previous years this figure was 98%). **) Ethanol recycled in for example biogas or wastewater treatment plants. ***) Incinerated at combined heat and power plants or at plants for special treatment of hazardous waste with energy recovery. 94 Novo Nordisk Annual Report 2008 Consolidated non-financial statements Notes – Performance indicators Social 7 Living our values Novo Nordisk’s performance improved or remained at a high level for all pa - rameters in the area of ’living our values’. In the annual climate survey, eVoice, the average of respondents’ answers as to whether ‘social and environmental issues are important for the future of the company’ improved by 0.1 to 4.5 (on a scale from 1–5, with 5 being the highest). Also in eVoice, the average of respondents’ answers as to whether ‘my manager’s behaviour is consistent with Novo Nordisk’s values’ increased by 0.1 to 4.3. Both are above the target of >_3.5. There was 99% fulfilment of action points arising from facilitations, thus exceeding the target of 80% fulfilment. At the end of the year all but two action points that should have been closed, were closed. Closure of these is actively pursued. In total, 210 action points should have been closed in 2008. This is 15% below 2007. Based on the facilitations conducted in 2007/2008 it is the opinion of the facilitators that Novo Nordisk is in com pliance with the Novo Nordisk Way of Management. Unit 2008 2007 2006 Importance of social and environmental issues for the future of the company *) Managers’ behaviour consistent with Novo Nordisk’s values *) Fulfilment of action points planned arising from facilitations of the NNWoM Scale 1–5 Scale 1–5 % 4.5 4.3 99 4.4 4.2 99 4.3 4.1 99 *) On a scale from 1–5, with 5 being the highest. 8 People By the end of 2008, Novo Nordisk employed 27,068 persons, an increase of 4% compared to 2007. The continued increase in the number of employees follows Novo Nordisk’s strategy for expansion. This number equals a full-time equivalent (FTE) of 26,575. It reflects increased activities in all business areas, particularly in sales & marketing. The ratio between men and women has changed slightly; at the end of 2008, 50.4% of the employees were men, as compared with 50.6% at the end of 2007. The rate of absence was slightly lower than in 2007 with a performance of 2.2. Employee turn over increased to 12.1% from 11.6%. One of Novo Nordisk’s key risks, as described on pp 24 –25, is an inability to attract and retain the right talent. The average answers of 10 equally weighted questions in the annual survey, eVoice, are used to calculate the level of ‘engaging culture’. In 2008, the con- solidated score was 4.2, up 0.1 from 2007. The target is to remain at a level of 4.0 or above on a scale from 1–5, with 5 being the highest. The average of re- spondents’ answers as to whether ‘my work gives me an opportunity to use and develop my competences/skills’ increased from 4.0 to 4.1, and the aver- age of respondents’ answers as to whether ‘people from diverse backgrounds have equal opportunities’ increased from 4.0 to 4.1; both were above the tar- get of >_3.5. Employees (total) – Female – Male Rate of absence Rate of employee turnover Engaging culture (employee engagement) *) Opportunity to use and develop competences/skills *) People from diverse backgrounds have equal opportunities *) *) On a scale from 1–5, with 5 being the highest. Unit Number % % % % Scale 1–5 Scale 1–5 Scale 1–5 2008 2007 2006 27,068 49.6 50.4 2.2 12.1 4.2 4.1 4.1 26,008 49.4 50.6 2.7 11.6 4.1 4.0 4.0 23,613 49.2 50.8 3.0 10.0 4.0 3.9 3.9 9 Health & safety Performance on the health & safety indicator ‘frequency of occupational injuries’ was satisfactory, as the frequency decreased from 5.9 to 5.4 in 2008, meeting the target of a continuous decrease. There were no fatalities in 2008. There is a continued focus on ensuring high health & safety standards for employees in Novo Nordisk. In 2008, adoption of a health & safety man- agement system certifiable according to OHSAS 18001 continued for Novo Nordisk in Denmark and Product Supply globally. All units in Product Supply were certified according to the OHSAS18001 in 2008. Frequency of occupational injuries Fatalities No/million work hrs Number 5.4 0 5.9 0 6.2 0 Unit 2008 2007 2006 Novo Nordisk Annual Report 2008 95 Consolidated non-financial statements Notes – Performance indicators Social (continued) 10 Access to health For 2008, Novo Nordisk offered its best possible pricing scheme, as part of the global health initiatives, to all 50 Least Developed Countries (LDCs) as defined by the United Nations. During 2008 Novo Nordisk sold insulin to either govern ments or to the private market in 32 of the LDCs at or below a price of 20% of the average prices for insulin in the Western world, compared to 36 in 2007. In 14 countries Novo Nordisk is not selling insulin at all, for various reasons. The four LDCs in which Novo Nordisk did not sell insulin at the policy price were Afghanistan, Cambodia, Nepal and Samoa. The public authorities in all countries have been offered the opportunity to buy insulin at the policy price. The insulin sold in Afghanistan, Cambodia and Nepal in 2008 was to the private market. In several cases, the government has not responded to the offer, there are no private wholesalers or other partners with whom to work, or wars or political unrest sometimes make it impossible to do business. While Novo Nordisk prefers to sell insulin at the preferential price through government tenders, the company is willing to sell to private LDCs where Novo Nordisk operates LDCs where Novo Nordisk sells insulin at or below the policy price Healthcare professionals trained or educated People with diabetes trained or treated distributors and agents. The target is to offer the best possible pricing scheme to the governments of all LDCs. Unfortunately, there is no way to guarantee that the price at which Novo Nordisk sells the insulin will be reflected in the final price on the pharmacist’s shelf. Wholesalers and pharmacies may mark up the drug before selling it to the consumer. A measure of the company’s contribution to global health is the number of healthcare professionals directly trained, educated, interacted with or reached through awareness campaigns, and the number of people with diabetes targeted with training, awareness or treatment. The aim is to continue activities to educate healthcare professionals and to train and treat people with diabetes. Since 2002, 380,000 healthcare professionals have been trained or educated and 1,854,000 people with diabetes have been trained or treated. Unit Number Number 1,000 1,000 2008 36 32 380 1,854 2007 38 36 336 1,260 2006 35 34 297 1,060 11 Business ethics In 2008, 99% of relevant employees in sales and marketing were trained in local binding business ethics rules. In total, 30% of Novo Nordisk’s employees were trained. All employees were trained in the updated version of the standard operating procedure for business ethics. The number of employees trained was, as expected, above the target of 90%. Employees in sales and marketing trained in business ethics Unit % 2008 99 2007 95 2006 NA 12 Company reputation The goal of Novo Nordisk is to improve (or maintain) the company reputation as measured by the mean brand score or at least be the leader in seven out of eight target groups. In 2008, this goal was achieved despite a slight decrease of the mean brand score of 1.6 from 74.0 to 72.4, because the company is leading in seven out of eight target groups. This confirms the leadership position in diabetes in the four core markets (China, Germany, UK and US). Improve (or maintain) company reputation with external key stakeholders Scale 0 –100 Unit 2008 72.4 2007 74.0 2006 73.8 13 Quality In 2008, no warning letters were issued to Novo Nordisk by the FDA in con- nection with GMP, GCP or GLP inspections. Nor were any re-inspections issued to Novo Nordisk. The target of no warning letters and no re-inspections has therefore been met. In total, 95 inspections were conducted in 2008. This performance is as expected. Warning letters and re-inspections Unit Number 2008 2007 2006 0 0 0 96 Novo Nordisk Annual Report 2008 Consolidated non-financial statements Notes – Performance indicators Social (continued) 14 Training costs In 2008, the annual spending on training, measured as average spent per employee, increased by 0.5%, which is almost the same level as in 2007, reflecting the company’s strategic prioritisation of talent and leadership devel- opment, and of lifelong learning offered to all employees. The average spent per employee does not reflect the complete investments in training in Novo Nordisk, since on-the-job training, internal seminars and other activities are not included. The increase in training cost per employee is not nearly as high as from 2006 to 2007, when the increase was 16%. The reason for the significant increase of 16% was due to extensive hiring in 2007 (10%). The level of new employees joining Novo Nordisk in 2008 and thus requiring additional training was not as high in 2008 (4%), explaining why the amount spent is almost unchanged. Annual training costs per employee Unit DKK 2008 2007 2006 13,192 13,130 11,293 15 Patent families The number of Novo Nordisk patent families developed as expected in 2008. The number of active patent families to date decreased by 11%. The number of new patent families (first filing) decreased from 116 in 2007 to 71 in 2008 – a decrease of 39%. Both decreases were due to the refocus in the R&D area in 2008, when the closure of R&D activities in oral anti diabetic agents, pulmonary insulin and cancer resulted in fewer active patent families and fewer applications for new patents. Active patent families to date New patent families (first filing) Unit Number Number 2008 890 71 2007 1,003 116 2006 913 149 16 Animals Novo Nordisk sets goals to reduce, refine and replace experiments on animals and to improve animal welfare. In line with a higher activity level in the discovery phase in 2008, there was a slight increase of 5% in the number of purchased animals, from a total of 54,675 in 2007 to 57,253 in 2008, of which 95% were mice and rats. Overall the numbers of purchased animals have been at the same level since 2005. 75% of the animals have been used at Novo Nordisk facilities in Denmark and 25% have been used at external collaborators. Animals purchased Unit Number 2008 2007 2006 57,253 54,675 56,533 Novo Nordisk Annual Report 2008 97 Consolidated non-financial statements Notes – Performance indicators Economics 17 Economics The development in the economic indicators was as expected. Expenditure on R&D is an important capacity builder for society and a source of innovation creating future profitability for Novo Nordisk. The ratio of R&D costs to tangible investments (4.3:1) reflects the continued increasing importance of R&D for Novo Nordisk. In the period 2004 –2008 this ratio varied from 1.4:1 to 4.3:1. The stabilisation in the share of R&D as a share of sales on 16.5% reflects the fact that R&D expenditure rose by 4.4% and sales rose by 9%. The wage share of R&D (40.4%) is an indication of the company’s impact as a capacity builder in the community. Most production facilities, 48% of the full-time employees and 79% of tangible assets are in Denmark. The level and location of the absolute invest- ment is a measure of the company’s economic capacity in the near future and reflects its aim to supply the market with products and to continue its globalisation. In 2008, Novo Nordisk invested DKK 1.7 billion primarily in Denmark (66%), but also in production facilities globally (in the US, Brazil, China and France), down from DKK 2.3 billion in 2007. Remuneration constituted 49% of the cash added value, mainly in the developed world, and particularly in Denmark where 57% of wages are paid and 48% of Novo Nordisk’s workforce is located. However, the share of full- time positions in International Operations increased 19% in 2007 to 21% in 2008. Sales per employee is DKK 1.7 million up from DKK 1.6 million in 2007, and the cash added value per employee is DKK 1.1 million, up from DKK 1 mil- lion in 2007, indicating a high and increasing pro ductivity of Novo Nordisk’s employees. In 2008, Novo Nordisk created 1,059 new positions globally and had 26,575 full-time positions; measured as full-time equivalents (FTE). These jobs translate into 61,925 indirect global jobs in the supply chain from production needs and employees’ private consumption. The majority relate to production (44,025) but the effect of private consumption by Novo Nordisk employees is also significant (17,900). Measured by sales in 2008, Novo Nordisk is the ninth largest company in Denmark, as in 2007. In terms of R&D costs Novo Nordisk is the largest Danish company and ranks as number 28 on a European scale (in 2007 numbers), up from number 30. Among European pharmaceutical companies Novo Nordisk ranks as number 6 by sales and R&D costs, down from number 5 in 2006. In 2008, total corporate taxes constituted 6.7% of sales. In Denmark, 13% of corporate taxes are paid as local taxes and 87% as state taxes. In 2008, Novo Nordisk accounted for an estimated 2.9% of Danish corporate taxes. Novo Nordisk employees accounted for an estimated 0.6% of total Danish income taxes and an estimated 0.6% of employment in Denmark. In total, Novo Nordisk’s income taxes in Denmark for the year amounted to DKK 1,031 million. Novo Nordisk’s sales in 2008 accounted for 2.6% measured as a share of Danish GDP, up from 2.4% in 2007, and 2.7% of Danish exports compared to 3.4% in 2007. R&D expenditure to tangible investments *) R&D as share of sales *) Remuneration as share of cash received Employment impact worldwide (direct and indirect) Total corporate tax as share of sales Novo Nordisk exports as share of Danish exports (estimated) *) R&D costs adjusted for costs related to discontinuation of all pulmonary diabetes projects. Unit Ratio % % Number of jobs % % 2008 2007 2006 4.3:1 16.5 31 88,500 6.7 2.7 3.2:1 17.2 32 81,600 5.9 3.4 2.3:1 16.3 33 82,700 7.0 4.0 To ensure transparency, more details on reported data and additional non-financial reporting are available online at annualreport2008.novonordisk.com. 98 Novo Nordisk Annual Report 2008 Consolidated non-ﬁ nancial statements Novo Nordisk’s economic stakeholder model Novo Nordisk’s economic stakeholder model This model illustrates Novo Nordisk, its economic stakeholders and the interactions that drive economic growth in well- developed societies. When, for instance, investors provide risk capital so that Novo Nordisk can develop new products, this will beneﬁ t patients, customers, employees and suppliers. For patients, in turn, the products from Novo Nordisk improve their ability to contribute to society. When employees, suppliers and investors spend their income on goods and services and make investments, they, too, contribute to wealth generation in society. And in their capacity as citizens in the local and global community, all economic actors pay taxes to the public sector in return for services. Novo Nordisk’s sustainable business practices are mechanisms that improve the outcome of the market economy model. The interactions and multiplier effects are illustrated by the blue circle linking the stakeholders. Investors/funders Risk capital for development and production of new products is rewarded through dividends and share prices (50% are non-Danish investors). (cid:119) C Society As a business, Novo Nordisk generates wealth for society and contributes to socioeconomic development through its sustainable business practices, investment, employment (estimated direct and indirect impact amounting to 88,500 jobs globally), and contribution to Denmark’s GDP is 2.6%, and 2.7% of Danish exports. As a pharmaceutical company, Novo Nordisk provides knowledge, R&D and healthcare products and outreach through improved awareness, diagnosis or treatment of diabetes for at least 113 million people. R a p e t it al u r n a n o d f n i n u v e n d s s t m e n t (cid:120) (cid:119) Remuneration Productivity (cid:120) Novo Nordisk provides products to the healthcare sector and quality of life to patients, dividends and return on investment to investors, income and proﬁ t to suppliers, wage income to employees and taxes to the public sector. (cid:119) Sales Products (cid:120) Employees 27,068 employees’ knowledge and productivity are a major part of the company’s intangible value. 52% of employees work outside Denmark. 31% of cash received is remuneration. Customers and patients Novo Nordisk’s products are sold to hospitals, doctors and healthcare professionals for treatment of their patients. Novo Nordisk has a 52% market share of the global insulin market (by volume) and 23% of the global diabetes care market (by value). M aterials (cid:120) (cid:119) Pay m ents Suppliers Suppliers proﬁ t from the location of Novo Nordisk in their local community and from the company’s need for long-term stable supply partnerships globally. An estimated 28,700 jobs are created at suppliers in Denmark and 44,025 globally. (cid:119) S e T a x e r vic s e s (cid:120) Public sector Tax payments fund services offered by the public sector. Novo Nordisk’s tax payments are an estimated 2.9% of corporate taxes in Denmark. Novo Nordisk’s employees in Denmark pay an estimated 0.6% of the country’s total income tax. In total, Novo Nordisk’s income taxes in Denmark for the year amounted to DKK 1,031 million. Cash value distribution (2008) DKK million Cash received Cash added value Customers Suppliers Company cash Cash received for products and services (from sales) Cash payments for materials, facilities and services *) Cash added value (cash received minus cash payments) Employees Investors/funders Public sector Management Remuneration Dividends, share repurchase and interest payments Taxes Future growth 45,064 16,151 28,913 14,141 7,617 3,172 3,983 100% 36% 31% 17% 7% 9% *) Cash payments outside Novo Nordisk. The ﬁ gure includes cash received from licence fees, realised exchange rate gains and interest income. 100% 49% 26% 11% 14% Novo Nordisk Annual Report 2008 99 Consolidated financial statements Companies in the Novo Nordisk Group Country Year of incorporation / acquisition Issued share capital / paid-in capital Percentage of shares owned Activity l t n e m p o e v e d d n a h c r a e s e R • s t n e m t s e v n I / s e c i v r e S • g n i t e k r a m d n a l s e a S • n o i t c u d o r P • Parent company Novo Nordisk A/S Subsidiaries by region Denmark 1931 DKK 634,000,000 – • • • • Austria Belgium Bulgaria Croatia Czech Republic Denmark Finland France France Germany Greece Hungary Ireland Italy Lithuania Macedonia Netherlands Norway Poland Europe 1974 Novo Nordisk Pharma GmbH 1974 S.A. Novo Nordisk Pharma N.V. 2005 Novo Nordisk Pharma EAD 2004 Novo Nordisk Hrvatska d.o.o. 1997 Novo Nordisk s.r.o. 2002 Novo Nordisk Region Europe A/S 1972 Novo Nordisk Farma OY 2003 Novo Nordisk Pharmaceutique SAS 1959 Novo Nordisk Production SAS 1973 Novo Nordisk Pharma GmbH 1979 Novo Nordisk Hellas Epe 1996 Novo Nordisk Hungary Sales and Trading Ltd. 1978 Novo Nordisk Limited 1980 Novo Nordisk Farmaceutici S.P.A. 2005 UAB Novo Nordisk Pharma 2006 Novo Nordisk Farma dooel 1983 Novo Nordisk B.V. 1965 Novo Nordisk Scandinavia AS 1996 Novo Nordisk Pharma Sp. z o.o. 1984 Novo Nordisk Comércio Produtos Farmace˜ uticos Limitada Portugal Romania Novo Nordisk Farma S.R.L. 2005 Serbia & Montenegro 2005 Novo Nordisk Pharma d.o.o. Belgrade (Serbia) 2007 Slovakia Novo Nordisk Slovakia s.r.o. 2006 Slovenia Novo Nordisk, trzˇenje farmacevtskih izdelkov d.o.o. 1978 Spain Novo Nordisk Pharma S.A. 1971 Sweden Novo Nordisk Scandinavia AB 2003 Switzerland Novo Nordisk FemCare AG 2000 Switzerland Novo Nordisk Health Care AG 1968 Switzerland Novo Nordisk Pharma AG 1977 United Kingdom Novo Nordisk Holding Limited 1978 United Kingdom Novo Nordisk Limited North America Novo Nordisk Canada Inc. Novo Nordisk Region North America A/S Novo Nordisk Delivery Technologies Inc. Novo Nordisk US Holdings Inc. Novo Nordisk Pharmaceutical Industries Inc. Novo Nordisk Inc. Japan & Oceania Novo Nordisk Pharmaceuticals Pty. Ltd. Novo Nordisk Region Japan & Oceania A/S Novo Nordisk Pharma Ltd. Novo Nordisk Pharmaceuticals Limited Canada Denmark United States United States United States United States Australia Denmark Japan New Zealand 1983 2003 2005 2007 1991 1982 1985 2002 1980 1990 EUR EUR BGN HRK CZK DKK EUR EUR EUR EUR EUR HUF EUR EUR LTL MKD EUR NOK PLN EUR RON EUR SKK EUR EUR SEK CHF CHF CHF GBP GBP CAD DKK USD USD USD USD 36,336 69,000 5,880,000 5,000,000 14,500,000 108,370,500 420,500 5,821,140 57,710,220 614,062 1,050,000 371,000,000 635 516,500 2,150,000 14,068,285 61,155 250,000 29,021,000 250,000 2,795,000 640,000 8,000,000 2,679,286 1,502,500 100,000 1,100,000 159,325,000 50,000 2,802,132 2,350,000 200 500,000 20,001,000 50,000 55,000,000 283,837,600 AUD DKK JPY NZD 500,001 15,500,000 2,104,000,000 1,000,000 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 100 Novo Nordisk Annual Report 2008 Consolidated financial statements Companies in the Novo Nordisk Group International Operations Aldaph SpA Novo Nordisk Pharma Argentina S.A. Novo Nordisk Pharma (Private) Limited Novo Nordisk Produção Farmacêutica do Brasil Ltda. Novo Nordisk Farmacêutica do Brasil Ltda. Novo Nordisk Farmacêutica Limitada Novo Nordisk (China) Pharmaceuticals Co., Ltd. Beijing Novo Nordisk Pharmaceuticals Science & Technology Co., Ltd. Novo Nordisk Region International Operation A/S Novo Nordisk Egypt, LLC Novo Nordisk Hong Kong Limited Novo Nordisk India Private Limited PT Novo Nordisk Indonesia Novo Nordisk Pars Novo Nordisk Ltd Novo Nordisk Lebanon s.a.r.l Novo Nordisk Pharma (Malaysia) Sdn Bhd Novo Nordisk Mexico S.A. de C.V. Novo Nordisk Pharma SAS Novo Nordisk Pharma Limited Novo Nordisk Pharma (Private) Limited Novo Nordisk Pharmaceuticals (Philippines) Inc Novo Nordisk Limited Liability Company Novo Investment Pte Ltd. Novo Nordisk Pharma (Singapore) Pte Ltd. Novo Nordisk (Pty) Ltd Novo Nordisk Pharma Korea Ltd Novo Nordisk Pharma (Taiwan) Ltd Novo Nordisk Pharma (Thailand) Ltd. Novo Nordisk Tunisie SARL Novo Nordisk Saglik Ürünleri Tic. Ltd. Sti. Novo Nordisk Pharma Gulf FZ-LLC Novo Nordisk Venezuela Casa de Representación C.A. Other subsidiaries FeF Chemicals A/S NNIT A/S *) NNE Pharmaplan A/S *) Steno Diabetes Center A/S Associated companies Harno Invest A/S Innate Pharma SA ZymoGenetics, Inc. Country Algeria Argentina Bangladesh Brazil Brazil Chile China China Denmark Egypt Hong Kong India Indonesia Iran Israel Lebanon Malaysia Mexico Morocco Nigeria Pakistan Philippines Russia Singapore Singapore South Africa South Korea Taiwan Thailand Tunisia Turkey United Arab Emirates Venezuela Denmark Denmark Denmark Denmark Denmark France United States *) In addition to the listed companies, NNIT A/S and NNE Pharmaplan A/S have own subsidiaries. Year of incorporation / acquisition Issued share capital / paid-in capital Percentage of shares owned 1994 1997 2007 2002 1990 2006 1994 2006 2002 2004 2001 1994 2003 2005 1997 2007 1992 2004 2006 2006 2005 1999 2003 1994 1997 1959 1994 1990 1983 2004 1993 2005 2004 1989 1998 1989 2008 1992 2006 1988 DZD ARS BDT BRL BRL CLP USD 1,742,650,000 7,465,150 17,500,000 896,834,727 84,727,136 758,271,200 83,800,000 2,000,000 USD 113,303,310 DKK 50,000 EGP 500,000 HKD 265,000,000 INR 827,900,000 IDR 10,000,000 IRR 100 ILS 600,000,000 LBP 200,000 MYR 239,491,127 MXN 2,597,000 MAD 10,000,000 NGN 10,000,000 PKR 50,000,000 PHP 188,243,360 RUB 12,000,000 SGD 200,000 SGD ZAR 8,000 KRW 6,108,400,000 9,000,000 TWD 15,500,000 THB 400,000 TND 25,296,300 TRY AED 100,000 2,250,000,000 VEB DKK DKK DKK DKK DKK EUR USD 10,000,000 1,000,000 500,000 500,000 70,419,910 1,295,600 781,505,000 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 49 100 100 100 100 100 100 100 100 30 18 30 Activity g n i t e k r a m d n a l s e a S • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • n o i t c u d o r P • • • • • • l t n e m p o e v e d d n a h c r a e s e R • s t n e m t s e v n I / s e c i v r e S • • • • • • • • • • Novo Nordisk Annual Report 2008 101 Consolidated financial statements Summary of financial data 2004 – 2008 DKK million Sales Sales by business segments: Modern insulins (insulin analogues) Human insulins Insulin-related sales Oral antidiabetic products (OAD) Diabetes care total Haemostasis management Growth hormone therapy Hormone replacement therapy Other products Biopharmaceuticals total Sales by geographical segments: Europe *) North America International Operations *) Japan & Oceania Licence fees and other operating income (net) Operating profit Operating profit (excl AERx ®) **) Net financials Profit before income taxes Income taxes Net profit Total assets Total current liabilities Total long-term liabilities Equity Investments in property, plant and equipment (net) Investments in intangible assets and long-term financial assets (net) Free cash flow ***) Net cash flow Ratios Sales in percent: Modern insulins (insulin analogues) Human insulins Insulin-related sales Oral antidiabetic products (OAD) Diabetes care total Haemostasis management Growth hormone therapy Hormone replacement therapy Other products Biopharmaceuticals total Sales outside Denmark as a percentage of sales Gross margin ***) Sales and distribution costs as a percentage of sales Research and development costs as a percentage of sales Research and development costs as a percentage of sales (excl AERx ®) **) Administrative expenses as a percentage of sales Net profit margin ***) Effective tax rate ***) Equity ratio ***) Payout ratio ***) Payout ratio adjusted for impact of Dako and discontinuation of AERx ® projects Long-term financial targets Operating profit margin ***) Operating profit margin (excl AERx ®) **) Growth in operating profit ***) Growth in operating profit (excl AERx ®) **) Growth in operating profit, three-year average ***) ROIC ***) Cash to earnings ***) Cash to earnings, three-year average ***) 102 Novo Nordisk Annual Report 2008 2004 2005 2006 2007 2008 29,031 33,760 38,743 41,831 45,553 4,507 13,033 1,350 1,643 7,298 13,543 1,463 1,708 10,825 13,451 1,606 1,984 14,008 12,572 1,749 2,149 20,533 24,012 27,866 30,478 17,317 11,804 1,844 2,391 33,356 6,396 3,865 1,612 324 5,635 3,309 1,607 326 5,865 3,511 1,668 309 10,877 11,353 12,197 15,300 12,280 6,494 4,669 272 9,119 – 45 9,164 2,712 6,452 44,692 10,157 4,413 30,122 2,787 244 4,707 463 27.9% 34.7% 4.2% 5.1% 71.9% 14.5% 8.6% 4.2% 0.8% 28.1% 99.2% 75.3% 30.0% 16.3% – 6.2% 16.7% 29.6% 67.4% 34.4% – 23.5% – 12.7% – 12.4% 25.8% 73.0% 80.2% 16,350 13,746 7,295 4,440 321 8,942 10,267 2,029 10,971 2,449 8,522 47,731 10,641 4,908 32,182 2,268 118 9,012 1,638 33.5% 30.1% 4.2% 5.1% 72.9% 14.0% 8.4% 4.0% 0.7% 27.1% 99.2% 76.6% 29.6% 20.4% 17.2% 6.0% 20.4% 22.3% 67.4% 32.8% 34.9% 17,219 15,154 8,425 4,755 286 12,373 12,698 322 12,695 3,050 9,645 50,603 12,958 4,666 32,979 1,754 264 11,015 4,111 38.0% 25.9% 4.0% 5.3% 73.2% 14.0% 8.5% 3.6% 0.7% 26.8% 99.2% 77.8% 28.2% 17.2% 16.5% 5.8% 21.2% 24.0% 65.2% 37.8% – 21.4% 24.5% (1.9%) 12.6% 8.9% 27.2% 105.7% 87.0% 27.2% 27.9% 38.4% 23.7% 16.4% 37.4% 114.2% 97.6% 4,359 2,317 1,488 334 8,498 12,887 7,478 4,368 4,298 575 6,980 – 477 7,457 2,444 5,013 37,433 7,280 3,649 26,504 2,999 312 4,278 2,136 15.5% 44.9% 4.6% 5.7% 70.7% 15.0% 8.0% 5.1% 1.2% 29.3% 99.3% 72.3% 28.5% 15.0% – 6.7% 17.3% 32.8% 70.8% 31.8% – 24.0% – 8.7% – 8.9% 21.5% 85.3% 59.0% 5,064 2,781 1,565 338 9,748 14,020 9,532 5,497 4,711 403 8,088 – 146 8,234 2,370 5,864 41,960 10,581 3,745 27,634 3,665 (136) 4,833 (634) 21.6% 40.1% 4.3% 5.1% 71.1% 15.0% 8.2% 4.6% 1.0% 28.9% 99.2% 72.8% 28.7% 15.1% – 6.3% 17.4% 28.8% 65.9% 33.2% – 24.0% – 15.9% – 11.0% 24.7% 82.4% 82.4% Consolidated financial statements Summary of financial data 2004 – 2008 – Supplementary information in EUR (unaudited) EUR million Sales Sales by business segments: Modern insulins (insulin analogues) Human insulins Insulin-related sales Oral antidiabetic products (OAD) Diabetes care total Haemostasis management Growth hormone therapy Hormone replacement therapy Other products Biopharmaceuticals total Sales by geographical segments: Europe *) North America International Operations *) Japan & Oceania Licence fees and other operating income (net) Operating profit Operating profit (excl AERx ®) **) Net financials Profit before income taxes Income taxes Net profit Total assets Total current liabilities Total long-term liabilities Equity Investments in property, plant and equipment (net) Investments in intangible assets and long-term financial assets (net) Free cash flow ***) Net cash flow Share data ****) Basic earnings per share in DKK ***) Diluted earnings per share in DKK ***) Dividend per share in DKK Number of shares at year-end (million) Number of shares outstanding at year-end (million) ***) Average number of shares outstanding (million) ***) Average number of shares outstanding incl. dilutive effect of options ‘in the money’ (million) Employees Total full-time employees at year-end Denmark Rest of Europe North America International Operations Japan & Oceania 2004 3,902 606 1,752 181 221 2,760 586 311 200 45 2005 4,531 979 1,819 196 229 3,223 680 373 210 45 2006 5,194 1,451 1,804 215 266 3,736 755 444 215 44 2007 5,614 1,880 1,687 235 288 4,090 788 471 224 41 2008 6,109 2,323 1,583 247 321 4,474 858 518 216 43 1,142 1,308 1,458 1,524 1,635 1,732 1,005 587 578 77 938 – 64 1,002 328 674 5,033 979 491 3,563 403 42 575 287 7.45 7.42 2.40 709.4 664.2 673.2 676.2 1,882 1,279 738 632 54 1,085 – 20 1,105 318 787 5,624 1,418 502 3,704 492 (18) 649 (85) 8.95 8.92 3.00 709.4 647.4 655.4 657.9 2,051 1,646 871 626 36 1,223 – 6 1,229 364 865 5,994 1,362 592 4,040 374 33 631 62 10.05 10.00 3.50 674.0 634.4 641.9 645.4 2,194 1,845 979 596 43 1,200 1,378 272 1,472 328 1,144 6,401 1,427 658 4,316 304 16 1,210 220 13.49 13.39 4.50 647.0 621.1 631.8 636.4 2,309 2,032 1,130 638 38 1,660 1,704 43 1,703 409 1,294 6,792 1,739 625 4,426 235 35 1,478 552 15.66 15.54 6.00 634.0 608.2 615.8 620.7 20,285 11,839 2,454 1,949 3,104 939 22,007 12,160 2,702 2,465 3,746 934 23,172 12,214 2,944 2,846 4,188 980 25,516 12,401 3,281 3,935 4,882 1,017 26,575 12,728 3,539 3,722 5,561 1,025 *) Comparative figures from 2004 –2006 have been adjusted in order to reflect a changed organisational structure from 1 January 2007 which transfers 8 countries, incl. Bulgaria and Romania, from International Operations to Europe. Excluding costs related to discontinuation of all pulmonary diabetes projects. **) ***) For definitions, please refer to page 88. ****) In 2007 there was a stock split of the company’s A and B shares. The trade unit was changed from DKK 2 to DKK 1. The comparative figures for 2004 to 2006 have been updated accordingly. Key figures are translated into EUR as supplementary information – the translation of income statement items is based on the average exchange rate in 2008 (EUR 1 = DKK 7.45593) and the translation of balance sheet items is based on the exchange rate at the end of 2008 (EUR 1 = DKK 7.45060). The figures in DKK reflect the economic substance of the underlying events and circumstances of the Group. Novo Nordisk Annual Report 2008 103 Consolidated financial statements Quarterly figures 2007 and 2008 (unaudited) DKK million Sales Sales by business segments: Modern insulins (insulin analogues) Human insulins Insulin-related sales Oral antidiabetic products (OAD) 2007 2008 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 9,818 10,563 10,504 10,946 10,614 11,110 11,246 12,583 3,065 3,136 419 523 3,464 3,222 437 529 3,568 3,098 445 585 3,911 3,116 448 512 3,821 2,939 443 640 4,103 2,966 460 478 4,365 2,806 464 671 5,028 3,093 477 602 Diabetes care total 7,143 7,652 7,696 7,987 7,843 8,007 8,306 9,200 Haemostasis management Growth hormone therapy Hormone replacement therapy Other products 1,411 784 406 74 1,508 924 411 68 1,427 878 414 89 1,519 925 437 78 1,440 878 385 68 1,648 986 391 78 1,534 941 394 71 1,774 1,060 442 107 Biopharmaceuticals total 2,675 2,911 2,808 2,959 2,771 3,103 2,940 3,383 Sales by geographical segments: Europe North America International Operations Japan & Oceania Gross profit Sales and distribution costs Research and development costs Research and development costs (excl AERx ®) *) Administrative expenses Licence fees and other operating income (net) Operating profit Operating profit (excl AERx ®) *) Net financials Profit before taxation Income taxes Net profit 3,931 3,214 1,696 977 7,498 3,048 1,647 – 614 138 2,327 – 47 2,374 665 4,035 3,424 1,953 1,151 8,205 3,110 1,754 – 594 60 2,807 – 1,587 4,394 742 4,036 3,500 1,870 1,098 7,990 2,993 1,724 – 623 31 2,681 – 175 2,856 672 4,348 3,608 1,776 1,214 8,345 3,220 3,413 2,088 677 92 1,127 2,452 220 1,347 370 4,061 3,450 2,096 1,007 8,201 2,975 1,858 1,638 627 88 2,829 3,049 39 2,868 688 4,400 3,467 2,069 1,174 8,556 3,178 1,980 1,825 626 74 2,846 3,001 405 3,251 780 4,305 3,759 2,074 1,108 8,640 3,155 1,579 1,629 633 51 3,324 3,274 182 3,506 842 4,453 4,478 2,186 1,466 10,047 3,558 2,439 2,439 749 73 3,374 – (304) 3,070 740 1,709 3,652 2,184 977 2,180 2,471 2,664 2,330 Depreciation, amortisation and impairment losses Depreciation, amortisation and impairment losses (excl AERx ®) *) 509 – 516 – 586 – 1,396 526 563 – 567 – 560 – 752 699 Total equity Total assets Ratios Gross margin Sales and distribution costs as a percentage of sales Research and development costs as a percentage of sales Research and development costs as a percentage of sales (excl AERx ®) *) Administrative expenses as a percentage of sales Operating profit margin Operating profit margin (excl AERx ®) *) Equity ratio Share data **) Basic earnings per share/ADR (in DKK) Diluted earnings per share/ADR (in DKK) Average number of shares outstanding (million) – basic Average number of shares outstanding (million) – diluted Employees 29,676 44,742 33,475 48,300 33,161 48,423 32,182 47,731 31,251 47,534 33,046 48,478 32,173 48,990 32,979 50,603 76.4% 77.7% 76.1% 76.2% 31.0% 29.4% 28.5% 29.4% 16.8% 16.6% 16.4% 31.2% 19.1% 6.2% 23.7% 26.6% 25.5% 10.3% 22.4% 66.3% 69.3% 68.5% 67.4% – 5.9% – 6.3% – 5.6% – – – 77.3% 77.0% 76.8% 79.8% 28.0% 28.6% 28.1% 28.3% 17.5% 17.8% 14.0% 19.4% 15.4% 16.4% 14.5% 19.4% 6.0% 26.7% 25.6% 29.6% 26.8% 28.7% 27.0% 29.1% 26.8% 65.7% 68.2% 65.7% 65.2% 5.9% 5.6% 5.6% 2.69 2.68 635.0 639.4 5.75 5.71 635.8 640.2 3.46 3.43 632.0 636.4 1.56 1.55 624.4 629.6 3.51 3.48 620.9 626.3 3.99 3.96 618.6 623.5 4.34 4.30 614.2 618.6 3.82 3.80 609.3 614.4 Number of full-time employees at the end of the period 24,045 24,729 25,206 25,516 25,765 26,060 26,360 26,575 *) Excluding costs related to discontinuation of all pulmonary diabetes projects. **) In December 2007 there was a stock split of the company’s A and B shares. The trade unit was changed from DKK 2 to DKK 1. The comparative figures have been updated accordingly. 104 Novo Nordisk Annual Report 2008 Financial statements of the parent company Financial statements of the parent company, Novo Nordisk A/S, for 2008 Novo Nordisk Annual Report 2008 105 Financial statements of the Parent company Novo Nordisk A/S Income statement DKK million Sales Cost of goods sold Gross profit Sales and distribution costs Research and development costs Administrative expenses Licence fees and other operating income (net) Operating profit Profit in subsidiaries Share of profit in associated companies Financial income Financial expenses Profit before income taxes Income taxes Net profit Proposed appropriation of net profit: Dividends Net revaluation reserve according to the equity method Retained earnings Note 2 3 3 3 3, 4 9 9 5 5 6 2008 2007 27,145 8,069 19,076 7,654 5,633 1,243 409 4,955 5,318 71 1,098 635 10,807 1,165 9,642 26,023 9,871 16,152 5,754 7,142 1,187 478 2,547 5,415 1,490 1,351 871 9,932 1,414 8,518 3,650 (5,422) 11,414 9,642 2,795 5,883 (160) 8,518 106 Novo Nordisk Annual Report 2008 DKK million Assets Intangible assets Property, plant and equipment Financial assets Total long-term assets Inventories Trade receivables Amounts owed by affiliated companies Tax receivables Other receivables Marketable securities and financial derivatives Cash at bank and in hand Total current assets Total assets Equity and liabilities Share capital Net revaluation reserve according to the equity method Retained earnings Exchange rate adjustments Total equity Long-term debt Deferred income tax liabilities Amounts owed to affiliated companies Other provisions Total long-term liabilities Short-term debt and financial derivatives Trade payables Amounts owed to affiliated companies Tax payables Other liabilities Other provisions Total current liabilities Total liabilities Total equity and liabilities Financial statements of the Parent company Novo Nordisk A/S Balance sheet Note 31 Dec 2008 31 Dec 2007 7 8 9 10 11 12 13 14 14 543 14,512 11,313 26,368 8,908 945 5,541 535 631 1,375 8,299 430 15,242 16,014 31,686 8,146 889 6,840 – 499 2,547 4,460 26,234 23,381 52,602 55,067 634 16,393 16,183 (256) 32,954 980 906 14 163 647 21,815 9,489 209 32,160 961 768 82 342 2,063 2,153 1,279 1,262 11,903 1 2,715 425 17,585 19,648 270 956 15,781 172 3,085 490 20,754 22,907 52,602 55,067 Novo Nordisk Annual Report 2008 107 Financial statements of the Parent company Novo Nordisk A/S Notes – Income statement To the extent it exceeds declared dividends from such companies, net revalua- tion of investments in subsidiaries and associated companies is transferred to net revaluation reserve according to the equity method under equity. Average number of full-time employees in Novo Nordisk A/S 3 Employee costs DKK million Wages and salaries Share-based payment costs Pensions Other contributions to social security Other employee costs Total employee costs Included in the Balance sheet as change in employee costs included in inventories 2008 2007 5,521 257 504 95 338 5,200 75 471 147 261 6,715 6,154 87 143 For information regarding remuneration to the Board of Directors and Executive Management please refer to consolidated accounts note 34, page 80–81. Reference is furthermore made to consolidated accounts note 33, page 78, and consolidated accounts note 34, page 81–82, for information regarding share-based payment schemes to the Board of Directors, Executive Management and the Senior Management Board. 2008 2007 10,693 10,412 2008 2007 17 7 21 8 4 Fees to statutory auditors DKK million PricewaterhouseCoopers of which statutory audit fee to PricewaterhouseCoopers 5 Financial income and Financial expenses DKK million 2008 2007 Interest income relating to subsidiaries included in Financial income Interest expenses relating to subsidiaries included in Financial expenses 2008 2007 Foreign exchange loss (net) recognised in the Income statement 164 162 410 608 68 51 26,802 343 25,316 707 27,145 26,023 10,535 7,520 5,880 3,210 10,972 6,482 5,631 2,938 27,145 26,023 6 Income taxes Of the total tax payment of DKK 3,172 million by the Group in 2008, the Parent company’s share of paid taxes relating to current year amounts to DKK 1,633 million. In 2007 the total tax payment by the Group amounted to DKK 2,607 million of which the Parent company’s share of paid taxes relating to current year amounted to DKK 1,381 million. 1 Accounting policies The Parent company’s financial statements have been prepared in accordance with the Danish Financial Statements Act (Class D), and other accounting regulations for companies listed on NASDAQ OMX Copenhagen. The accounting policies for the Parent company are unchanged compared to last financial year and are the same as for the Group with the following additions. For a description of the accounting policies of the Group please see note 1 – Summary of significant accounting policies, page 56 – 60. Supplementary accounting policies for the Parent company Financial assets In the financial statements of the Parent company investments in subsidiaries and associated companies are recorded under the equity method, that is at the respective share of the net asset values in subsidiaries and associated companies. Any cost in excess of net assets in the acquired company is capitalised in the Parent company under Financial assets as part of invest- ments in subsidiaries (‘Goodwill’). Amortisation of goodwill is provided under the straight-line method over a period not exceeding 20 years, based on estimated useful life. Net profit of subsidiaries less unrealised intercompany profits is recorded in the Income statement of the Parent company. Fair value adjustments of financial assets categorised as ‘Available for sale’ are recognised in the Parent company in the Income statement. The presentation of profit in subsidiaries is now shown as profit after tax. Comparable figures for 2007 have been changed accordingly. The reclassifica- tion has no impact on the net profit or equity. Tax The Parent company is assessed jointly for Danish tax purposes with its domestic subsidiaries. The Danish jointly taxed companies are included in a Danish on-account tax payment scheme for Danish corporate income tax. All current taxes under the scheme are recorded in the individual companies. Cash flow statement No separate cash flow statement has been prepared for the Parent company – please see the Consolidated cash flow statement and financial resources in this Annual Report, page 54. 2 Sales DKK million Sales by business segments *) Diabetes care total Biopharmaceuticals total Total sales Sales by geographical regions *) Europe North America International Operations Japan & Oceania Total sales Sales are attributed to geographical areas based on location of the customer. *) For definitions of the segments please refer to consolidated accounts note 4, page 62. 108 Novo Nordisk Annual Report 2008 Financial statements of the Parent company Novo Nordisk A/S Notes – Balance sheet 7 Intangible assets DKK million Cost at the beginning of the year Additions during the year Disposals during the year Cost at the end of the year Amortisation at the beginning of the year Amortisation during the year Impairment losses for the year *) Depreciation reversed on disposals during the year Amortisation at the end of the year Carrying amount at the end of the year *) Impairment losses of DKK 117 million in 2007 relates to discontinuation of AERx ®. 8 Property, plant and equipment DKK million Cost at the beginning of the year Additions during the year Disposals during the year Transfer from/(to) other items Cost at the end of the year Depreciation and impairment losses at the beginning of the year Depreciation for the year Impairment losses for the year *) Depreciation reversed on disposals during the year Depreciation and impairment losses at the end of the year Goodwill Patents and licences Software 51 – – 51 51 – – – 51 0 418 172 – 590 147 8 50 – 205 385 362 30 – 392 203 23 8 – 234 158 2008 Total 831 202 – 1,033 401 31 58 – 490 543 2007 Total 800 80 (49) 831 296 26 117 (38) 401 430 Land and buildings Plant and machinery Other equipment Payments on account and assets in course of construction 2008 Total 2007 Total 9,312 33 (259) 334 13,066 78 (292) 308 9,420 13,160 2,873 359 6 (235) 3,003 6,298 1,161 90 (268) 7,281 1,400 64 (41) 273 1,696 842 152 3 (32) 965 731 1,477 976 (53) (915) 25,255 1,151 (645) – 25,186 1,452 (1,383) – 1,485 25,761 25,255 – – 53 (53) – 10,013 1,672 152 (588) 9,625 1,549 58 (1,219) 11,249 10,013 1,485 14,512 15,242 Carrying amount at the end of the year 6,417 5,879 *) Impairment losses of DKK 53 million relates to discontinuation of all pulmonary diabetes projects in 2008. The latest valuation of properties of the parent company for property tax purposes amounts to a total of DKK 2,443 million (DKK 2,447 million in 2007). Cost of property not officially valued amounts to DKK 355 million (DKK 658 million in 2007). Novo Nordisk Annual Report 2008 109 Financial statements of the Parent company Novo Nordisk A/S Notes – Balance sheet 9 Financial assets DKK million Cost at the beginning of the year Additions during the year Disposals during the year Cost at the end of the year Value adjustments at the beginning of the year Profit/(loss) before tax Income taxes on profit for the year Amortisation and impairment of goodwill Dividends received Disposals during the year Exchange rate adjustments Other adjustments Value adjustments at the end of the year Offset against amounts owed by subsidiaries at the beginning of the year Additions during the year At the end of the year Unrealised internal profit at the beginning of the year Change for the year Exchange rate adjustments At the end of the year Investments in subsidiaries Amounts owed by affiliated companies Investments in associated companies Other securities and investments 2008 Total 2007 Total 6,443 1,750 – 8,193 21,152 7,965 (1,885) – (11,502) – 455 (561) 15,624 164 (103) 61 (12,190) (762) (322) (13,274) 73 36 (26) 83 – – – – – – – – – – – – – – – – 295 318 (12) 601 (16) 71 – (3) (178) – – 10 (116) – – – – – – – 376 93 (6) 463 (283) – – – – – – (39) (322) – – – – – – – 7,187 2,197 (44) 9,340 20,853 8,036 (1,885) (3) (11,680) – 455 (590) 7,216 41 (70) 7,187 15,232 8,562 (1,035) (4) (1,620) – (93) (189) 15,186 20,853 164 (103) 61 (12,190) (762) (322) 11 153 164 (8,447) (4,015) 272 (13,274) (12,190) Carrying amount at the end of the year 10,604 83 485 141 11,313 16,014 Carrying amount of investments in subsidiaries does not include capitalised goodwill at the end of the year. No additions or disposals were made during the year. Carrying amount of investments in associated companies includes net capitalised goodwill of DKK 61 million at the end of the year (DKK 65 million in 2007). A list of companies in the Novo Nordisk Group is included on pages 100 to 101. 10 Inventories DKK million Raw materials and consumables Work in progress Finished goods Total inventories Indirect production costs included in work in progress and finished goods Amount of write-down of inventories recognised as expense during the year Amount of reversal of write-down of inventories during the year 2008 1,160 6,683 1,065 8,908 2007 1,077 6,048 1,021 8,146 4,536 4,027 733 48 188 81 110 Novo Nordisk Annual Report 2008 Financial statements of the Parent company Novo Nordisk A/S Notes – Balance sheet 11 Statement of changes in equity DKK million Balance at the beginning of the year Appropriated from net profit for the year Proposed dividends Appropriated from net profit for the year to net revaluation reserve according to the equity method Purchase of treasury shares Sale of treasury shares Share-based payments Reduction of the B share capital Dividends Exchange rate adjustment of investments in subsidiaries Deferred (gain)/loss on cash flow hedges at the beginning of the year recognised in the Income statement Deferred gain/(loss) on cash flow hedges at the end of the year Other adjustments Share capital Net revaluation reserve 647 21,815 (5,422) (13) Retained earnings 9,489 11,414 3,650 (4,717) 295 331 13 (2,795) (615) (940) 58 Exchange rate adjustments 209 (473) 8 2008 Total 2007 Total 32,160 11,414 3,650 (5,422) (4,717) 295 331 – (2,795) (473) (615) (940) 66 30,104 (160) 2,795 5,883 (4,835) 241 75 – (2,221) 53 (420) 691 (46) Balance at the end of the year 634 16,393 16,183 (256) 32,954 32,160 Regarding average number of shares please refer to note 13, page 65. Regarding total number of A and B shares in Novo Nordisk A/S and treasury shares please refer to note 21, page 71. 12 Long-term debt DKK million Mortgage debt Other long-term debt Total long-term debt Long-term debt falling due after more than five years from the balance sheet date amounts to At the end of 2008 none of the long-term debt was falling due within one year. 13 Deferred income tax liabilities DKK million The deferred tax assets and liabilities are allocated to the various balance sheet items as follows: Property, plant and equipment Indirect production costs Unrealised profit on intercompany sales Other Total income tax liabilities The deferred income tax has been calculated using a tax rate of 25%. 2008 2007 504 476 980 462 504 457 961 504 2008 2007 1,305 1,134 (1,541) 8 1,274 1,007 (1,270) (243) 906 768 Novo Nordisk Annual Report 2008 111 Financial statements of the Parent company Novo Nordisk A/S Notes – Balance sheet 14 Other provisions DKK million At the beginning of the year Additional provisions Adjustments to previous year’s provisions Used during the year At the end of the year Specification of provisions: Long-term Current Total other provisions Provisions for returned products Other provisions 490 174 (160) (79) 425 – 425 425 342 21 – (200) 163 163 – 163 2008 Total 832 195 (160) (279) 588 163 425 588 2007 Total 689 396 (171) (82) 832 342 490 832 15 Commitments and contingencies 16 Related party transactions DKK million 2008 2007 For information on transactions with related parties please refer to note 32, page 77. 17 Financial risk For information on financial risk please refer to note 31, page 76. Commitments Lease commitments Contractual obligations relating to investments in property, plant and equipment Guaranties given for subsidiaries Obligations related to research and development projects Other guarantees and commitments Leasing commitments expiring within the following periods as from the balance sheet date Within one year Between one and five years After five years Total lease commitments 600 612 99 2,184 764 1,793 84 1,515 2,471 1,478 109 247 244 600 107 254 251 612 The lease costs for 2008 and 2007 were DKK 223 million and DKK 233 million respectively. Security for debt Land, buildings and equipment etc at carrying amount 1,255 1,989 For information on pending litigation and other contingencies please refer to note 36, page 86. 112 Novo Nordisk Annual Report 2008 Consolidated financial statements Management statement The Annual Report has the below Management Statement and Independent Auditor’s reports as provided on page 114 –115. Statement by the Board of Directors and Executive Management on the Annual Report Today, the Board of Directors and Executive Management approved the Annual Report of Novo Nordisk A/S for the year 2008. The Consolidated financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (IASB), and with International Financial Reporting Standards as adopted by the EU, and the Financial Statements of the Parent company, Novo Nordisk A/S, have been prepared in accordance with the Danish Financial Statements Act. Further, the Annual Report has been prepared in accordance with the additional Danish annual report requirements for listed companies. In our opinion, the accounting policies used are appropriate and the Annual Report gives a true and fair view of the Group’s and the Parent company’s assets, liabilities, equity, financial position and results, and the consolidated cash flows, together with a description of the material risk and uncertainties the group faces. Novo Nordisk’s non-financial statements have been prepared in accordance with the non-financial reporting principles of materiality, completeness and responsiveness of AA1000AS (2003). It represents a balanced and reasonable presentation of the organisation’s economic, environmental and social performance. Gladsaxe, 28 January 2009 Executive Management: Lars Rebien Sørensen President and CEO Jesper Brandgaard CFO Lise Kingo Kåre Schultz Mads Krogsgaard Thomsen Board of Directors: Sten Scheibye Chairman Göran A Ando Vice chairman Kurt Briner Henrik Gürtler Johnny Henriksen Pamela J Kirby Anne Marie Kverneland Kurt Anker Nielsen Chairman of the Audit Committee Søren Thuesen Pedersen Stig Strøbæk Jørgen Wedel Audit Committee member Novo Nordisk Annual Report 2008 113 Independent Auditor’s report Independent Auditor’s report on the Annual Report for 2008 To the Shareholders of Novo Nordisk A/S We have audited the Annual Report of Novo Nordisk A/S for the financial year 2008, which comprises Management Statement, Management Report, significant accounting policies, income statement, balance sheet, statement of changes in equity and notes for the Group as well as for the Parent Com pany and consolidated cash flow statement (page 2– 88, 100 –102 and 105 –113). The Consolidated Financial Statements are prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board, and with International Financial Reporting Standards as adopted by the EU, and the Parent Company Financial State ments are prepared in accordance with the Danish Financial Statements Act. Further, the Annual Report is prepared in accordance with additional Danish disclosure requirements for annual reports of listed companies. Management’s Responsibility for the Annual Report Management is responsible for the preparation and fair presentation of the Annual Report in accordance with the said legislation and accounting standards. This responsibility includes: designing, implementing and main- taining internal control relevant to the preparation and fair presentation of an Annual Report that is free from material misstatement, whether due to fraud or error; selecting and applying appropriate accounting policies; and making accounting estimates that are reasonable in the circumstances. Auditor’s Responsibility Our responsibility is to express an opinion on the Annual Report based on our audit. We conducted our audit in accordance with International and Danish Auditing Standards. Those Standards require that we comply with ethical requirements and plan and perform the audit to obtain reasonable assurance that the Annual Report is free from material misstatement. An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the Annual Report. The procedures selected depend on the auditor’s judgment, including the assessment of the risks of material misstatement of the Annual Report, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the Company’s preparation and fair presentation of the Annual Report in order to design audit procedures that are appropriate in the circumstances. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of accounting estimates made by Management, as well as evaluating the overall presentation of the Annual Report. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion. Our audit has not resulted in any qualification. Opinion In our opinion, the Annual Report gives a true and fair view of the financial position at 31 December 2008 of the Group and of the results of the Group operations and consolidated cash flows for the financial year 2008 in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board, and with International Financial Reporting Standards as adopted by the EU, and additional Danish disclosure requirements for annual reports of listed companies. In addition, in our opinion, the Annual Report gives a true and fair view of the financial position at 31 December 2008 of the Parent Company and of the results of the Parent Company operations for the financial year 2008 in accordance with the Danish Financial Statements Act and additional Danish disclosure requirements for annual reports of listed companies. Gladsaxe, 28 January 2009 PricewaterhouseCoopers Statsautoriseret Revisionsaktieselskab Mogens Nørgaard Mogensen Danish State Authorised Public Accountant 114 Novo Nordisk Annual Report 2008 Independent Auditor’s reports Independent Assurance Report on the Non-financial Reporting 2008 Subject, responsibilities, objective and scope of assurance statement We have reviewed the non-financial information in the Annual Report of Novo Nordisk A/S for the financial year 2008, which comprises the Manage - ment Statement, the Management Report, the Non-financial accounting policies and the Consolidated non-financial statements on page 2– 50, 89–99 and 113 (the ‘Non-financial Reporting’). Our review has been performed with a view to express a conclusion on the Non-financial Reporting against the principles of materiality, completeness and responsiveness of the AA1000 Assurance Standard (AA1000AS (2003)) and to express a conclusion on whether the Non-financial Reporting is free of material misstatements and has been presented in accordance with the non-financial accounting policies. • the Annual Report includes significant non-financial information material to Novo Nordisk’s corporate stakeholders; • the inclusion of information is aligned with robust and well-functioning governance and risk management structures and processes as well as regular, formal and informal stakeholder engagement and systematic trend spotting activities ensuring attention to key corporate stakeholders’ concerns and expectations. Completeness Nothing has come to our attention that would cause us not to believe that: Management’s responsibility Management is responsible for collecting and presenting the non-financial information in the Non-financial Reporting. Basis of conclusion Our work was undertaken to perform an evaluation of the Non-financial Reporting against the principles of materiality, completeness and respons - iveness of the AA1000AS (2003). Moreover, we planned and performed our work in accordance with the International Standard on Assurance Engage - ments (ISAE) 3000, ‘Assurance Engagements other than Audits or Review of Historical Financial Information’, to obtain limited assurance that the Non- financial Reporting is free of material misstatements and that the information has been presented in accordance with the non-financial accounting policies. Based on an assessment of materiality and risk, our work included, on a sample basis, a review of management systems, reporting structures and boundaries. The assurance obtained is limited, as our work compared to that of an engagement with reasonable assurance has been limited principally to inquiries, interviews and analytical procedures related to registration and communication systems, data and underlying documentation. We reviewed whether data and the underlying components are accounted for in such a way as to fulfil the assertions of materiality and completeness in accordance with the non-financial accounting policies. In addition, our work comprised an assessment of stakeholder engagement and of the materiality of reporting against peer-reporting, media reports and industry knowledge. Our work also included an assessment of significant estimates made by Management. We believe that the work performed provides a reasonable basis for our conclusion. Conclusion Based on the work performed, we state our conclusion in relation to each of the key principles of the AA1000 Assurance Standard (2003): materiality, completeness and responsiveness. Materiality Nothing has come to our attention that would cause us not to believe that: • the Non-financial Reporting presents a fair and balanced representation of Novo Nordisk’s material corporate non-financial performance and impacts; • the reported non-financial targets and indicators in general are used in strategic and operational decision-making, and some of these are included in top management, management and business units’ Balanced Scorecard; • Novo Nordisk can identify and understand material aspects of its corporate non-financial performance as well as significant impacts outside the boundaries of which it has direct management control, including upstream and downstream issues such as social and environmental performance of suppliers, the animal health practices of contract research organisations, carbon emissions of energy suppliers, training of healthcare professionals, and accessibility for less developed countries to medicine at reduced prices; • Novo Nordisk has an effective process in place at corporate level for identifying, exploring and defining its approach to material impacts while an equally effective approach is not mirrored in some local levels of the organisation. Responsiveness Nothing has come to our attention that would cause us not to believe that: • through the Non-financial Reporting and other communications, Novo Nordisk is responsive to significant issues raised by corporate stakeholders in an accessible manner; • Novo Nordisk has an effective process and relevant governance structures in place for defining its response to corporate stakeholders as well as processes to promote the integration of such responses into management and business processes. In some areas, such as responsible purchasing, additional controls could be put in place to ensure consistent and effective implementation of responses; • Novo Nordisk has corporate policies, programmes and procedures to address material stakeholder concerns in key pharmaceutical industry areas such as business ethics and marketing practices, bioethics (including clinical trials and animal welfare), access to health, and advocacy. Based on our review, nothing has come to our attention that causes us not to believe that the non-financial information in the Annual Report of Novo Nordisk for the financial year 2008 is free of material misstatements and has been presented in accordance with the non-financial accounting policies. Commentary According to AA1000AS (2003), we are required to include recom- mendations for improvements in relation to environmental and social responsibility. The recommendations, as well as our statement of independence and competences, are stated in ‘How we are accountable’ at annualreport2008.novonordisk.com. Our recommendations do not affect the above-stated conclusion. Gladsaxe, 28 January 2009 PricewaterhouseCoopers Statsautoriseret Revisionsaktieselskab Mogens Nørgaard Mogensen Danish State Authorised Public Accountant Novo Nordisk Annual Report 2008 115 Additional information Index Index This index might be of help if you are looking for speciﬁ c information. It includes topics covered in this Annual Report and additional information available online at novonordisk.com. Topic of interest Covered in this report Online information About Novo Nordisk pp 6–7 annualreport2008.novonordisk.com /who-we-are/about-novo-nordisk.asp Access to health Accountability Advocacy Animal welfare pp 36–37, 96 annualreport2008.novonordisk.com /how-we-perform/access-to-health/default.asp pp 89, 91 pp 34–35 pp 26, 97 annualreport2008.novonordisk.com/how-we-are-accountable/default.asp annualreport2008.novonordisk.com/how-we-perform/responsible-business-practices/advocacy/default.asp annualreport2008.novonordisk.com/how-we-perform/responsible-business-practices/bioethics/animal-welfare.asp Audit and assurance pp 44, 89, 91–92, 114–115 annualreport2008.novonordisk.com/how-we-are-accountable/audit-assurance.asp Awards and recognitions – annualreport2008.novonordisk.com/who-we-are/awards-and-recognition.asp Biopharmaceuticals Board of Directors pp 38–41 pp 46–47 novonordisk.com/about_us novonordisk.com/about_us/management/board_of_directors.asp Brand and reputation management pp 90, 96 novonordisk.com/about_us/changing-diabetes/default.asp Business ethics Business strategy Capital structure Changing Diabetes® Climate change Clinical trials pp 26, 90, 96 annualreport2008.novonordisk.com/how-we-perform/responsible-business-practices/business-ethics.asp pp 22–23 pp 49–50 pp 34–35 pp 28–29, 93 pp 18–19, 26 annualreport2008.novonordisk.com/who-we-are/vision-and-strategy.asp novonordisk.com/about_us/ownership/ownership.asp annualreport2008.novonordisk.com/how-we-perform/responsible-business-practices/advocacy/changing-diabetes.asp annualreport2008.novonordisk.com/how-we-perform/environment-health-and-safety/environmental-management/climate-change.asp annualreport2008.novonordisk.com/how-we-perform/responsible-business-practices/bioethics/clinical-trials.asp Community engagement p 35 annualreport2008.novonordisk.com/how-we-perform/people-and-communities/community-engagement.asp Compliance Corporate governance Deﬁ nitions Diabetes care Diversity Donations Economic footprint Environment Executive Management Financial performance Gene technology Global Compact pp 26, 93 pp 42–43 pp 88, 91–92 pp 30–37 pp 27, 90, 95 pp 37, 41 p 99 annualreport2008.novonordisk.com/who-we-are/governance/compliance.asp annualreport2008.novonordisk.com/who-we-are/governance/corporate-governance.asp annualreport2008.novonordisk.com/how-we-are-accountable/default.asp novonordisk.com/diabetes/public/default.asp annualreport2008.novonordisk.com/how-we-perform/people-and-communities/people/diversity.asp annualreport2008.novonordisk.com/how-we-perform/people-and-communities/community-engagement/donations.asp annualreport2008.novonordisk.com/how-we-perform/people-and-communities/socio-economics.asp pp 28–29, 93–94 annualreport2008.novonordisk.com/how-we-perform/environment-health-and-safety/environmental-management/default.asp p 48 pp 8–14 p 93 novonordisk.com/about_us/management/executive_management.asp annualreport2008.novonordisk.com/how-we-perform/ﬁ nancial-performance/default.asp annualreport2008.novonordisk.com/how-we-perform/responsible-business-practices/bioethics/gene-technology.asp pp 26, 36, 89 annualreport2008.novonordisk.com/how-we-perform/un-global-compact/default.asp Global Reporting Initiative (GRI) p 89 annualreport2008.novonordisk.com/how-we-perform/gri/default.asp Health and safety Human rights Legal issues Materiality Memberships pp 29, 95 p 26 annualreport2008.novonordisk.com/how-we-perform/environment-health-and-safety/health-and-safety.asp annualreport2008.novonordisk.com/how-we-perform/responsible-business-practices/advocacy/default.asp pp 26, 86–87 annualreport2008.novonordisk.com/how-we-perform/ﬁ nancial-performance/legal-issues.asp p 89 – annualreport2008.novonordisk.com/how-we-are-accountable/materiality.asp annualreport2008.novonordisk.com/who-we-are/memberships.asp Novo Nordisk Way of Management p 20 annualreport2008.novonordisk.com/who-we-are/nn-way-of-management.asp Partnerships People strategy Pipeline Product stewardship Quality Remuneration Responsible sourcing Risk management Share information Social responsibility Socioeconomics Stakeholder engagement Stem cells Sustainability pp 34–37 p 27 pp 18–19 – annualreport2008.novonordisk.com/who-we-are/partnerships.asp annualreport2008.novonordisk.com/how-we-perform/people-and-communities/people/people-strategy.asp novonordisk.com/investors/rd_pipeline/rd_pipeline.asp annualreport2008.novonordisk.com/how-we-perform/environment-health-and-safety/environmental-management/product-stewardship.asp pp 25, 90, 96 annualreport2008.novonordisk.com/how-we-perform/responsible-business-practices/quality.asp pp 44–45 p 26 pp 24–25 p 49 annualreport2008.novonordisk.com/how-we-perform/people-and-communities/people/wages-and-beneﬁ ts.asp annualreport2008.novonordisk.com/how-we-perform/responsible-business-practices/responsible-sourcing.asp annualreport2008.novonordisk.com/who-we-are/governance/risk-management.asp novonordisk.com/investors/share_information/share_information.asp pp 20–21, 95–97 novonordisk.com/sustainability/sustainability_in_short/default.asp pp 98–99 annualreport2008.novonordisk.com/how-we-perform/people-and-communities/socio-economics.asp p 91 – annualreport2008.novonordisk.com/who-we-are/stakeholder-engagement/default.asp annualreport2008.novonordisk.com/how-we-perform/responsible-business-practices/bioethics/stem-cells.asp pp 20, 89 novonordisk.com/sustainability/default.asp Talent development pp 29, 90, 95 annualreport2008.novonordisk.com/how-we-perform/people-and-communities/people/talent-development.asp Tax Triple Bottom Line Workplace quality pp 12, 98 annualreport2008.novonordisk.com/how-we-perform/responsible-business-practices/tax.asp pp 20–21, 89–99 annualreport2008.novonordisk.com/who-we-are/triple-bottom-line.asp pp 95–97 annualreport2008.novonordisk.com/how-we-perform/people-and-communities/people/default.asp 116 Novo Nordisk Annual Report 2008 Additional information Contacts Transfer agents Shareholders’ enquiries concerning dividend payments, transfer of share certiﬁ cates, consolidation of shareholder accounts and tracking of lost shares should be addressed to Novo Nordisk’s transfer agents: Danske Bank Holmens Kanal 2–12 1092 Copenhagen K Denmark Tel +45 3344 0000 In North America: JP Morgan Chase Bank PO Box 3408 South Hackensack, NJ 07606 USA Tel +1 800 990 1135 Tel +1 201 680 6630 for enquiries from outside the United States Produced by Global Triple Bottom Line Management, February 2009 Contributing writer Amy Brown Translation Anne Nielsen and Corporate Communications Photos Anders Bøggild, DONG Energy, Ulrik Jantzen, Novo Nordisk and Jesper Westley Design and production ADtomic Communications Accounts and notes production Team2graphics Printed in Denmark by Bording A/S (DS/EN ISO14001:1996) Chen Kai, Area Business Manager of Western China Region, centre, led a team of Novo Nordisk employees who delivered food and medical supplies to areas of China affected by the May 2008 earthquake. 2 3 4 5 6 Contacts Novo Nordisk values stakeholders’ reviews of the company’s reporting and welcomes any questions or com- ments concerning the report or the company’s performance. Visit the corporate website at novonordisk.com. This report is about how we do business. When it comes to building relations, that is what Novo Nordisk people across the globe do every day. If reading the report inspires you to learn more or to get involved in some of the work, please get in touch. Headquarters Novo Nordisk A/S Novo Allé 2880 Bagsværd Denmark Tel +45 4444 8888 webmaster@novonordisk.com Media Corporate Communications Novo Nordisk A/S Novo Allé 2880 Bagsværd Denmark Mike Rulis Tel +45 4442 3573 E-mail: mike@novonordisk.com Investor Relations Mads Veggerby Lausten Tel +45 4443 7919 E-mail: mlau@novonordisk.com Kasper Roseeuw Poulsen Tel +45 4442 4471 E-mail: krop@novonordisk.com In North America: Hans Rommer Tel +1 609 919 7937 E-mail: hrmm@novonordisk.com References 1 Garber A, Henry R, Ratner R et al. Liraglutide as compared to glimepiride monotherapy in a 52-week, phase 3 study of subjects with type 2 diabetes: LEAD-3 (mono). Lancet. 2008. 2 King, A B, et al. A randomized, cross- over, double-blind comparison of insulin detemir and insulin glargine daily blood glucose proﬁ les in subjects with type 2 diabetes. Presented at the American Diabetes Association, June 2008. 3 Hanaire, A B, et al. Insulin-naïve patients with type 2 diabetes and higher BMI experience weight loss when initiated onto insulin detemir: 12-week, 26-week and 52-week follow- up data from PREDICTIVE™. Presented at the European Association for the Study of Diabetes, September 2008. 4 Shaban, J, Hansen J B, Yang W Y. NovoMix®30 (BIAsp 30) Improves Glycemic Control in Type 2 Diabetes: Results from the IMPROVE™ Study. American Diabetes Association. 68th Scientiﬁ c Sessions; 2008 June 7–10; San Francisco, CA. Abstract Number: 2108. 5 Estimated number of patients using FlexPen®, based on worldwide sales in numbers of packs sold, IMS worldwide data Q2’08 and Daily Deﬁ ned Dosage (DDD) for insulin as issued by WHO. 6 Innovation in Health Care: The Economics of Diabetes. Study conducted by The Lewin Group®, commissioned by the National Changing Diabetes Program®, a program of Novo Nordisk, Inc. Novo Nordisk sponsored a ﬁ ve km run as part of the 2008 meeting of the European Association for the Study of Diabetes. Novo Nordisk’s key products This report makes reference to European product trade names. The list below provides an overview of European trade names with accompanying generic names. Trade and generic names may differ in the US and Japan. For a complete overview of country-speciﬁ c product names, please visit novonordisk.com Click: Your COUNTRY. Therapeutic area Trade name Generic name Diabetes care Modern insulins Levemir® NovoRapid® NovoMix® Human insulins Insulatard® Actrapid® Diabetes devices FlexPen® NovoPen® 4 InnoLet® NovoFine® GlucaGen® Insulin detemir Insulin aspart Biphasic insulin aspart Insulin human Insulin human Preﬁ lled insulin delivery system Durable insulin delivery system Preﬁ lled insulin delivery system Needle Glucagon Oral antidiabetic agent NovoNorm® PrandiMet® Repaglinide Repaglinide/metformin Biopharmaceuticals Haemostasis NovoSeven® Recombinant factor VIIa NovoSeven RT™ Recombinant factor VIIa Human growth hormone Norditropin® NordiFlex® Somatropin (rDNA origin) Preﬁ lled multidose delivery system NordiFlex PenMate® Automatic needle insertion accessory NordiPen® Preﬁ lled multidose delivery system NordiPenMate® Preﬁ lled multidose delivery system NordiLet® HRT Activelle® Estrofem® Novofem® Vagifem® Preﬁ lled multidose delivery system Estradiol/norethisterone acetate Estradiol Estradiol/norethisterone acetate Estradiol hemihydrate n a N o v o N o r d i s k A / S A n n u a l R e p o r t 2 0 0 8 Our focus is our strength Javier Viguera, 24, a top-ranked tennis player from Spain believes that diabetes has been a positive force in his life. He was ﬁ ve years old when he was diagnosed with type 1 diabetes but his parents taught him that it would not stand in the way of a normal life, or even an extraordinary life. Today, in addition to excelling at his chosen sport, Javier is studying for a law degree at the University of Seville. “Diabetes has helped me be more responsible and demanding with myself,” he says. It was diabetes, in fact, that led him to pick up a tennis racket at the age of seven. “Sport came to play an important role in my life, since exercise is essential to stabilise levels of glucose,” he explains. At age 12 Javier Viguera became the best player in his region of Spain, which led to the opportunity to be trained by Juan Carlos Ferrero, former number-one player in the world. Javier has consistently ranked among the best players of his age in Spain. He was ranked among the 100 best players in his age group worldwide when he was 16. With law and tennis, he is pursuing all the dreams he had as a boy and hopes that his example will inspire others. For more than 85 years, Novo Nordisk has been committed to improv- ing diabetes care for people like Javier Viguera. Novo Nordisk A/S Novo Allé 2880 Bagsværd Denmark CVR number 24 25 67 90 novonordisk.com Printed on paper from recycled ﬁ ber, well- managed forests and controlled sources.

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