Novo Resources
Annual Report 2019

Plain-text annual report

Novo Nordisk Annual Report 2019 ROSHNI Roshni has type 1 diabetes and lives in India Contents Management review Consolidated statements Introducing Novo Nordisk Consolidated financial statements Letter from the Chair 01 02 Letter from the CEO 04 Novo Nordisk at a glance 06 Performance highlights Our business Leading a sustainable business Innovative treatments and solutions for unmet needs 08 11 14 Pipeline overview 16 International Operations: Building a sustainable platform for accelerated growth North America Operations: Ready for growth in a challenging business environment 20 2019 performance and 2020 outlook 18 Governance 29 Managing risks to protect value 32 Shares and capital structure 34 Corporate governance 38 Board of Directors 40 Executive management Income statement 42 43 Cash flow statement 44 Balance sheet 45 Equity statement 46 Notes to the consolidated financial statements Consolidated social statement (Supplementary information) 78 Statement of social performance 78 Notes to the consolidated social statement Consolidated environmental statement (Supplementary information) 84 Statement of environmental performance 84 Notes to the consolidated environmental statement Additional information 87 Management´s statement and Auditor´s reports 91 More information 92 Product overview Roshni lives in India, and loves her school. She is 12 years old and wants to become a doctor. Roshni was diagnosed with type 1 diabetes at the age of four. The first few months were tough. It was hard to get the blood sugar levels right. Then she was referred to a hospital and enrolled in Novo Nordisk’s Changing Diabetes in Children programme, which offers free insulin, help on managing diabetes and support for her and her family. The patient portrayed in this Annual Report have participated of her own accord and solely to express her personal opinions on topics referred to, which do not necessarily reflect the views and opinions of Novo Nordisk. Use of her pictures as illustrations is in no way intended to associate them with the promotion of any Novo Nordisk products. All references can be found in 'More information'. The Management review, as defined by the Danish Financial Statements Act, is found on pp 1-40 and pp 88-91. This Annual Report is Novo Nordisk’s full statutory Annual Report 2019. Please read further details in 'More information'. Novo Nordisk Annual Report 2019Letter from the Chair Making good progress Novo Nordisk made good progress during 2019. Our teams have delivered growth and crucial new product launches. This has established a good platform for the next decade and beyond as we continue to build our pipeline and make progress as a sustainable business. pleased to say that these changes are now bearing fruit, as evidenced by an accelera- tion of sales in International Operations, a return to growth in our Biopharm business, and a reinvigorated pipeline with great potential to offer treatment for unmet medical needs. We recognise that relying solely on in-house research capabilities will not be enough to sustain success, and we are therefore open- ing our business to strategic partnerships. Novo Nordisk’s market strength and deep expertise in metabolic diseases makes the company an attractive partner for innova- tive biotech companies. This has allowed us to build partnerships to bring on-board promising new technologies. As a large company, Novo Nordisk also has large responsibilities. Society is expecting more from business to help solve challenges such as bending the curve on diabetes, climate change and environmen- tal degradation. I believe Novo Nordisk, with its purpose and commitment to pursuing a more sustainable development, is well placed to rise to the challenge. The pharmaceutical industry faces an important societal challenge: how can we continue to innovate and improve health outcomes while at the same time ensuring that as many people as possible have access to our products at an afford- able price? This issue has been discussed at every board meeting I have chaired. I believe our initiatives for enhancing access to care represent real progress towards re- Our strategy is working. Although the challenges facing Novo Nordisk are not going away – indeed, many problems such as intensified competition, healthcare affordability and the need to bolster R&D are more urgent than ever – we have put in place the building-blocks for responding to these and other challenges. The Board of Directors is confident that Novo Nordisk is well positioned to deliver on its purpose of defeating diabetes and other serious chronic diseases and, by doing so, achieve profitable growth. Last year, we laid out our plans to repriori- tise resources towards key growth areas, streamline operations and redefine our research and development strategy. I am 1 solving this dilemma. And so do the major prevention programmes targeting obesity and diabetes. The decisions taken by companies like ours will help shape the future of societies for generations to come, whether that means bending the curve of the global diabetes epidemic or eliminating our environmental footprint, another area of priority for Novo Nordisk. Over the past year, I have visited our offices in many parts of the world. I have met people on the front line of operations who have told me how working for a company committed to improving healthcare and promoting sustainability motivates them. The insights from these meetings, and the discussions I have had with patients and our investors, have brought external per- spectives into the boardroom. The lesson I take away is simple: purpose comes first, profit is an outcome. A clear purpose and ambition to add value to society beyond financial results helps attract the top talent, thereby fuelling innovation and making Novo Nordisk a more sustainable company. In the course of 2019, two long-tenured colleagues, Jesper Brandgaard, executive vice president of Biopharm & Global Legal & Patents, and Lars Green, executive vice president of Business Services & Compli- ance, both left Novo Nordisk to pursue their careers elsewhere. I want to thank them both for the legacy they leave and commend them for their dedication and leadership and for the achievements they made on behalf of Novo Nordisk. New members were brought on board from outside of Novo Nordisk. Ludovic Helfgott joined in April 2019 as executive vice president and head of Biopharm. Monique Carter, who joined Novo Nordisk in November 2018, was promoted in August 2019 to executive vice president of People & Organisation. On behalf of the Board, I would like to offer my thanks to all Novo Nordisk’s employees for their hard work and commit- ment during 2019; to Lars Fruergaard Jørgensen and his team for their inspiring leadership and to our shareholders for their continued support. • Helge Lund Chair of the Board of Directors Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo NordiskGovernanceLetter from the CEO Setting new strategic aspirations Our purpose is to drive change to defeat diabetes and other serious chronic diseases. That is a long-term commitment, and we are pursuing it relentlessly. We build on our innovation expertise and our therapy focus combined with commercial excellence to provide benefits to the millions of patients who rely on our products. When we do that well, we will be a sustainable business that adds value to society and delivers profitable growth. As we enter a new decade, Novo Nordisk stands strong. We delivered a very solid financial result for 2019 reflecting an accelerated growth in International Operations and the contribution from the launch of Ozempic® particularly in North America Operations. Three milestones stand out: in the US, we secured a major scientific achievement with the regulatory approval of Rybelsus®, the world’s first and only GLP-1 medicine in a tablet, and early feedback indicates promising prospects. In January 2020, Ozempic®, a once-weekly injectable GLP-1, was approved in the US for cardiovascular risk reduction in people with type 2 diabetes and established cardiovascular disease. Ozempic® is now available in 26 countries and achieved blockbuster status within 18 months. We have introduced strategic aspirations in four categories with medium-term goals to provide direction towards 2025: purpose and sustainability; innovation and therapeutic focus; commercial execution; and financials. I invite you to also look at our company’s performance from this holistic perspective, because that is how 2 we manage the business. These aspirations replace our long-term financial targets. We hold ourselves accountable for progress towards each and all of them, and in the following pages we elaborate on the new aspirations. Our key contribution is to discover and de- velop innovative biological medicines and make them accessible to patients all over the world. Today, we have best-in-class products in all the therapy areas in which we are active, and at the end of 2019 our sales and marketing teams have delivered no fewer than 87 successful launches, delivering innovative treatments to people living with diabetes, obesity, haemophilia and growth hormone disorders. We are accelerating growth in International Operations where we now aspire to grow annual sales by 6-10% until 2025 from a historical level of 5-6%. Meanwhile, we are transforming our US business, and it is our ambition that by 2022 around 70% of our sales will come from new products. It is also encouraging to note that our Biopharm business has proven robust in the face of disruptive competition and has grown in both the haemophilia and growth hormone disorder product segments. One of the greatest opportunities for Novo Nordisk is undoubtedly obesity care, where there are huge unmet needs. We have already established a leading position in this field and expect to build on the success of Saxenda®, which is now available in 46 countries. In 2020 we will see the results of our pivotal clinical programme, STEP, which evaluates the benefits of injectable semaglutide for the treatment of obesity. Our contribution to global health relies on our ability to develop radically new treatments and solutions and we are well positioned to do this. We have raised the innovation-bar and are bolstering our pipeline, making significant advances in R&D productivity by harnessing digital tech- nologies to accelerate development of new product candidates. We believe we have what it takes to potentially even disrupt how diabetes is treated. To complement our in-house capabilities to develop novel therapies we partner with leading biotech companies like bluebird bio and Dicerna. All of these accomplishments demonstrate how we are indeed driving change to benefit patients and delivering convincing results. Results that are Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo NordiskGovernance3 reflected in strong financial performance and achievement of our long-term financial targets. But in a world where serious chronic diseases not only have a significant impact on individuals’ quality of life, but also ham- per socio-economic development and put a strain on healthcare budgets, it takes more than medicines. We consider it our respon- sibility to help tackle these challenges. That is what we mean by driving change. through education and on-the-ground interventions. Our Cities Changing Diabetes programme now involves 25 cities. In 2019, we entered a partnership with UNICEF to develop interventions that can help prevent childhood overweight and obesity worldwide, with an initial focus on Latin America and the Caribbean. And through our partnership with the Interna- tional Red Cross, we are providing essential insulin to thousands of people who are affected by humanitarian crises. We are stepping up our efforts to ensure broader access to our medicines for those who need them, regardless of their circum- stances. Ensuring affordability of medicines is a high priority for us, and we have expanded our affordable insulin offerings in the US, where our offerings provide a solid safety net for uninsured patients, and in low- and middle-income countries, where healthcare systems are inadequate. During 2019, we launched an ambitious new environmental strategy, Circular for Zero, which will take us towards our ultimate ambition, namely to ensure zero environmental impact from our activities. As of this year, our entire global production sources renewable power and the next major milestone in sight is to eliminate CO2 entirely from all operations and transport by 2030. be successful we must set ambitious goals, and we must work in a simple and agile way and nurture an inclusive workplace that enables everyone to realise their potential. We aim to be a truly sustainable business – environmentally, socially and financially. From the very beginning, this is how we have built our business, sticking with the Novo Nordisk Way. I am confident that we have a solid formula for delivering on our purpose, contributing to global sustainable development and sustaining commercial success. Let me close by thanking everyone at Novo Nordisk for all their great work and their commitment to our shared purpose. A special thanks to our Board of Directors for their decisive stewardship, constructive challenges and unwavering confidence. I also want to thank our shareholders and all our other stakeholders for their continued support. • We are working with partners across the globe to advance disease prevention With the Novo Nordisk Way as our guide, we will continue to evolve our culture. To Lars Fruergaard Jørgensen President & chief executive officer Strategic aspirations for 2025 Purpose and sustainability Innovation and therapeutic focus Commercial execution Financials • Being respected for • Further raise the • Strengthen Diabetes care • Deliver solid sales and adding value to society innovation-bar for leadership – aim at a operating profit growth diabetes treatment global value market – Deliver 6–10% sales • Progress towards zero share of more than 1/3 growth in International environmental impact • Develop a leading Operations portfolio of superior • Strengthen Obesity care – Transform 70% of sales • Ensure distinct core treatment solutions for leadership and double in the USA2 capabilities and evolve obesity current sales¹ culture • Drive operational • Strengthen and progress • Secure a sustained efficiencies across the the Biopharm pipeline growth outlook for value chain to enable Biopharm investments in future • Establish presence in Other serious chronic diseases focusing on cardiovascular disease, non-alcoholic steato- hepatitis and chronic kidney disease growth assets • Deliver free cash flow to enable attractive capital allocation to shareholders 1. Based on 2019 sales 2. From 2015 to 2022 Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo NordiskGovernance Introducing Novo Nordisk Our business Governance Consolidated statements 4 Novo Nordisk at a glance Novo Nordisk is a global health- care company, headquartered in Denmark. Our key contribu- tion is to discover and develop innovative biological medicines and make them accessible to patients throughout the world. We aim to lead in all disease areas in which we are active. 463 million people live with diabetes1 650 million people live with obesity2 1.1 million people live with Haemophilia3 1.8-2.9 in every 10,000 children is born with growth hormone defi ciency4 43,258 employees world wide 80 countries with affi liates or offi ces 169 countries with marketed products 3 continents with research and development facilities Our corporate strategy Diabetes care Strengthen leadership by offering innovative medicines and driving patient outcomes 9 1 0 2 t r o p e R l a u n n A k s i d r o N o v o N Biopharm Secure a leading position by leveraging full portfolio and expanding into adjacent areas N o ay v o N ordisk W Driving change to defeat diabetes and other serious chronic diseases ustainable b u s i n e ss S Obesity care Strengthen treatment options through market development and by offering innovative medicines and driving patient outcomes Other serious chronic diseases Establish presence by building competitive pipeline and scientifi c leadership 5 Financially responsible Socially responsible Environmentally responsible Our key contribution is to discover and develop innovative biological medicines and make them accessible to patients throughout the world. We rely on external fi nancial, environmental and social resources and leverage our core capa- bilities to create value for patients, employees, partners and shareholders. Deep disease understanding Adding value to society The company’s Articles of Association spell out the obligation to do business in a financially, environmentally and socially responsible way. This approach is applied to ensure that business decisions are better informed, always keeping in mind the best interests of the patients we serve and with an aim to create value for all stakeholders. Our business model Expertise from academic institutions Manufactured goods Insights from healthcare experts and patients Raw materials, water and energy Resources Financial resources Diverse talent Effi cient large-scale production of proteins Global commercial reach and leader in chronic disease care Core capabilities Financially responsible Environmentally responsible Socially responsible Engineering, formulating, developing and delivering protein-based treatments Value created 30 million people using Novo Nordisk Diabetes care products DKK 34,743 million to shareholders as dividends and share repurchases DKK 27,527 million total tax contribution Approx. 5,000 investigator sites active in Novo Nordisk-sponsored clinical trials More than 1 billion insulin penfi lls produced 43,258 employees of which 5,507 new hires Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo NordiskGovernance6 Performance highlights DKK million Financial performance Net sales Sales growth in constant exchange rates1 Net sales growth as reported Operating profit Net financials Profit before income taxes Net profit for the year Total assets Equity Purchase of property, plant and equipment1 Free cash flow1 Financial ratios1 Percentage of sales: Gross margin Operating margin Net profit margin Sales and distribution costs Research and development costs Administrative costs Equity ratio Return on equity Cash to earnings Payout ratio Long-term financial targets1 Operating profit growth Operating profit growth adjusted2 Operating profit growth in constant exchange rates adjusted2 Operating profit after tax to net operating assets Cash to earnings (three-year average) 2015 2016 2017 2018 2019 2018–2019 107,927 111,780 111,696 111,831 122,021 8.4% 21.5% 49,444 (5,961) 43,483 34,860 91,799 46,969 5,224 34,222 85.0% 45.8% 32.3% 26.2% 12.6% 3.6% 51.2% 79.9% 98.2% 46.6% 43.3% 35.2% 12.7% 148.7% 96.8% 5.5% 3.6% 48,432 (634) 47,798 37,925 97,539 45,269 7,068 39,991 84.6% 43.3% 33.9% 25.4% 13.0% 3.5% 46.4% 82.2% 105.4% 50.2% (2.0%) 3.9% 6.2% 150.2% 102.4% 2.3% (0.1%) 48,967 (287) 48,680 38,130 4.6% 0.1% 47,248 367 47,615 38,628 5.6% 9.1% 52,483 (3,930) 48,553 38,951 102,355 110,769 125,612 49,815 7,626 32,588 51,839 9,636 32,536 57,593 8,932 34,451 84.2% 43.8% 34.1% 25.4% 12.5% 3.4% 48.7% 80.2% 85.5% 50.4% 1.1% 1.1% 4.8% 84.2% 42.2% 34.5% 26.3% 13.2% 3.5% 46.8% 76.0% 84.2% 50.6% (3.5%) (3.5%) 2.8% 143.2% 116.7% 96.4% 91.7% 83.5% 43.0% 31.9% 26.1% 11.7% 3.3% 45.8% 71.2% 88.4% 50.5% 11.1% 11.1% 5.6% 98.0% 86.0% Change 9% 11% 2% 1% 13% 11% (7%) 6% Target 5% 80% 85% The Group has applied IFRS 16 'Leases' for the first time on 1 January 2019. Amounts for 2015-2018 have not been restated. Please refer to note 1.2. 1. See ’Financial definitions’. 2. Years 2015 and 2016, adjusted for DKK 2,376 million from the partial divestment of associated company and DKK 449 million from the income related to the out-licensing of assets for inflammatory disorders respectively. Sales by therapeutic area Diabetes care Obesity care Haemophilia Growth disorders Other Biopharm Sales by geographic area Region Europe Region AAMEO Region China Region Japan & Korea Region Latin America North America Operations Patients reached with diabetes care products (estimate) Ceiling price* Regular pricing 6% 1% 8% 5% 19% 2019 11% 2019 11% 80% 5% 4% 50% Million 30 25 20 15 10 5 0 2015 2016 2017 2018 2019 * Patients reached with insulin below ceiling price of USD 4.00/vial of human insulin. Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo NordiskGovernance7 Performance highlights 2015 2016 2017 2018 2019 2018–2019 Social performance Patients reached with Novo Nordisk's diabetes care products (estimate in millions) Patients reached with Novo Nordisk's diabetes care products via the Access to Insulin Commitment (estimate in millions) Employees (total) Employee turnover Gender in management (ratio men:women) Relevant employees trained in business ethics Product recalls Failed inspections Long-term social targets Employee engagement Company trust (scale 0–100) Environmental performance Water consumption for production sites (1,000 m3) Waste from production sites (1,000 tons) Long-term environmental targets Share of renewable power for production sites CO2 emissions from operations and transportation (1,000 tons) Share performance Basic earnings per share/ADR in DKK1 Diluted earnings per share/ADR in DKK1 Total number of shares (million), 31 December Dividend per share in DKK Total dividend (DKK million) Share repurchases (DKK million) Closing share price (DKK) 26.8 28.0 27.7 29.2 30.0 — — 41,122 42,446 9.2% 59:41 98% 9.7% 59:41 99% 2 0 — — 6 0 — — 0.3 42,682 11.0% 60:40 99% 6 0 0.3 43,202 11.7% 60:40 99% 3 0 90% 82.2 91% 84.5 3,131 159 3,293 153 3,276 157 3,101 142 78% — 78% — 79% — 77% 278 13.56 13.52 2,600 6.40 16,230 17,229 399.90 14.99 14.96 2,550 7.60 19,048 15,057 254.70 15.42 15.39 2,500 7.85 19,206 16,845 334.50 15.96 15.93 2,450 8.15 19,547 15,567 297.90 2.9 3 43,258 11.4% 60:40 99% 4 0 91% 78.2 3,149 124 76% 306 16.41 16.38 2,400 8.35 4 19,651 4 15,334 386.65 Change 3% — 0% 33% Target ≥ 90 ≥ 80 Change 2% (13%) Target 100% by 2020 0 by 2030 Change 3% 3% (2%) 2% 1% (1%) 30% 1. See ’Financial definitions’. 3. Scope of Access to Insulin Commitment expanded in 2019 to also include middle-income countries and selected organisations providing humanitarian relief. 4. Total dividend for the year including interim dividend of DKK 3.00 per share, which was paid in August 2019. The remaining DKK 5.35 per share, corresponding to DKK 12.551 million, will be paid subject to approval at the Annual General Meeting. Employees (total) Region Europe Region AAMEO Region China Region Japan & Korea Region Latin America North America Operations Water consumption Locations with high water stress or large seasonal variations* Other locations Thousand 14% CO2 emissions from operations and transportation Company cars Business flights Product distribution Office buildings and laboratories Production 20% 29% 2019 2019 2015 2016 2017 2018 2019 * As defined by the World Resource Institute 21% 86% 4% 26% 50 40 30 20 10 0 Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo NordiskGovernance Introducing Novo Nordisk Our business 8 Purpose and sustainability: Leading a sustainable business Our business is built on a commitment to drive change to defeat diabetes and other serious chronic diseases. We do so by pioneer- ing scientific breakthroughs and expanding access to our medi- cines. But we do not stop at that. We are also working to prevent, and ultimately cure, these diseases. We have a legacy in diabetes of almost a century, and over the years we have expanded into other serious chronic diseases. There will not be resources to provide for adequate chronic care for all who need it. In the public debate strong voices are questioning our business model and current practices for intellectual property rights, putting pressure on the price of es- sential medicines, and expecting us to take more responsibility for solving the problems caused by the pandemic growth of chronic diseases as well as other global issues. We want to be part of the solution, and we are stepping up to that challenge. We envisage a future in which markets and governments will punish companies that are seen to cause harm to people, com- munities or the environment through their products or operations, and reward those that account transparently for their impacts and benefit society. Our aspiration is to be respected for adding value to society. We take leadership in the concerted efforts to achieve good health and well being for all. We have also committed to take action in the face of climate change, with a bold ambition to leave zero environmental footprint from our business activities. Our strategy is informed by the global goals for sustainable development towards 2030 set by world leaders in 2015. We can help deliver on these goals. Preventing the rise in diabetes and obesity In a world strained by the impact of dia- betes, we have a responsibility to respond to the societal challenge. The burden of diabetes, fuelled by increasing rates of overweight and obesity, is rising in every part of the world despite long-running, col- lective efforts to fight the pandemic and its devastating impact on people and societies. To defeat diabetes, we need a new level of commitment. Prevention of diabetes and obesity is systematically underfunded and there are few, if any effective models that adequately address inequality in health. We want to find, pilot and scale effective ways to prevent people at risk from developing diabetes and obesity. In support of the Sustainable Development Goals, we are working with partners across the globe to advance disease prevention through education and on-the-ground in- terventions. Our Cities Changing Diabetes programme has become a social movement in its own right, mobilising multiple stake- holders in the effort to tackle the growing issues of urban diabetes and build healthier environments. By now we have 25 partner cities. Strategic aspirations for 2025 Purpose and sustainability • Being respected for adding value to society • Progress towards zero environmental impact • Ensure distinct core capabilities and evolve culture In 2019, we entered a partnership with UNICEF to develop interventions that can help prevent childhood overweight and obesity worldwide, with an initial focus on Latin America and the Caribbean. Through this partnership we will combine efforts to enhance knowledge and awareness and address root causes. The aim is three-fold. We want to enhance knowledge among decision-makers on successful policies to prevent childhood overweight and obesity in middle-income countries. We will build awareness of the impact of overweight and obesity on children and their rights and advocate for the need to make systemic changes to address this growing epidemic. And finally, we will drive and strengthen multi-sector interventions. With the right medical treatment and care, people with serious chronic diseases can live a life free of complications and be fully productive citizens. But as long as there is a significant gap between those who achieve good health and those who do not, the sit- uation is unsustainable and will impact our ability to be successful for the long-term. We are stepping up our efforts to provide broader access to our medicines for those who need them. We will actively be part of ensuring that more people are given access to diagnosis and that Novo Nordisk medicines are available and affordable, and we will continue to develop new and innovative treatments to further improve health outcomes for patients. Meanwhile, we will also support prevention by building capacity in health systems and societies. When we succeed at all this, it will ulti- mately lead to better health and thereby help contain the vast societal and financial burden arising from chronic diseases. Access to affordable care for vulnerable populations Novo Nordisk operates in 169 countries with vastly different levels of income and Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo Nordisk Our business 9 health systems. As a global healthcare company, we know that different ap- proaches are needed to ensure that the most vulnerable people receive the care they need. For this reason, Novo Nordisk has put in place a number of initiatives aimed at ensuring that vulnerable groups have access to affordable medicines and care, including: • Through our Access to Insulin Commit- ment we have set a ceiling price of USD 4 for a 10 ml vial of Human Insulin offered to governments in low- and middle- income countries and to humanitarian organisations. • Through the Changing Diabetes® in Children programme we provide insulin free of charge to children with type 1 diabetes and build capacity in the world’s poorest countries. In 2019, we enrolled 2,819 additional children. In to- tal 15,121 health care professionals have been trained, 208 clinics established and 25,695 children across 14 countries have received care as part of the programme since 2009. • We work to strengthen capacity to diagnose and treat people affected by humanitarian crises through Partnering for Change with the International Com- mittee of the Red Cross and the Danish Red Cross. • Through the World Diabetes Founda- tion, we support large-scale diabetes capacity building in low-resource settings and through the Defeat NCD partnership we support a new multi- sector effort to improve global access to care for non-communicable diseases. In September 2019, the United Nations adopted the Political Declaration on Uni- versal Health Coverage in support of the Sustainable Development Goals. In Novo Nordisk we welcome this effort to find sus- tainable solutions and we will continue to expand our own efforts to provide access to our products and strengthen capacity to diagnose and treat diabetes throughout the world. Affordable insulin in the US Ensuring affordability of medicines within the complex US healthcare system contin- ues to be a high priority. This year, we met face-to-face with some of our most vocal critics in the insulin pricing debate – includ- ing patients and physicians – to improve our understanding of the affordability challenges that patients are facing. And we are continuing to launch initiatives to help more people with diabetes access afford- able medicine – including those with insur- ance and those without – as we continue to support a longer-term, systemic reform. New insulin affordability offers, effective as of January 2020, include: • A Cash Card Program, offering that for USD 99, people with diabetes can get up to three vials or two packs of FlexPen®/ FlexTouch®/PenFill® pens of any combi- nation of Novo Nordisk Inc. insulins. • NovoLog® and NovoLog® Mix follow-on brands are made available in vials and pens at a 50 percent list price reduc- tion from the newly established Novo Nordisk Pharma Inc. • An immediate, one-time insulin supply option available for people facing an acute need when more time is needed to identify a sustainable solution. These new options build upon our existing offers: • The Patient Assistance Program, which we have offered since 2003. This pro- vides free medicines, including all Novo Nordisk insulin medications, to eligible patients. Families of four with an annual income up to USD 103,000 can get free medications through our Patient Assistance Program (USD 49,960 for individuals). • We have made Novo Nordisk human insulin available at Walmart for about USD 25/vial for the past 15 years, and recently expanded it to other national pharmacy chains. • Our Co-pay Savings Cards help spread the costs of commercially insured pa- tients with high out-of-pocket costs. Pursuing zero environmental impact Our long-standing climate action efforts are paying off. We expect to meet our target of using only renewable power in our production by 2020. The final stretch was the result of a new investment in a 2.7 square kilometre solar panel installation in North Carolina, USA, which will make power supplies for our entire US produc- tion carbon-free from early 2020. Our next ambitious target is to achieve zero CO2 emissions from all operations and transport by 2030. This target is part of our ‘Circular for Zero’ environmental strategy, which ultimately aims for zero environmen- tal impact from our business. We focus on three key areas: • Circular supply: we will collaborate proactively with suppliers to embed circular thinking for reduced environ- mental impact across our value chain and switch towards circular sourcing and procurement. • Circular company: we aim to eliminate environmental footprint from Novo Nordisk operations and drive a circular transition across the company aspiring for zero environmental impact. • Circular products: we will upgrade existing and design new products based on circular principles and solve the end- of-life product waste challenge to close the resource loop. Sustainable business approach As a business with global reach, we are defining our role in contributing to an environment, society and economy that enables all people, and our business, to thrive. Our ambition is to be a sustainable business that adds value to society. By that we mean staying in business – because millions of people rely on us – and con- tributing to the achievement of global sustainable development. In our approach, we adhere to interna- tional standards, including the UN Guiding Principles on Business and Human Rights, voluntary commitments such as the UN Global Compact Ten Principles and the recommendations of the Task Force on Climate-related Financial Disclosures. We also diligently adhere to compliance re- quirements such as the US Foreign Corrupt Practices Act, the UK Bribery Act and the UK Modern Slavery Act. And throughout, we seek to integrate sustainability in all our operations. For example, environmental considerations are included in the project manual for develop- ment of new products, ensuring that deci- sions are informed by life cycle assessments of environmental impacts. So how will we know when we are doing enough – throughout our value chain? We are changing the way we manage, track and report on progress to be a sustainable business. Taking our point of departure in what science and international standards have defined to be necessary in a global context, we follow a robust approach to identify current state and required actions through a focused, long-term effort. Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo Nordisk Our business 10 Our four Transformational Research Units, which pursue novel treatment forms and platform technologies, illustrate this type of cultural evolution. These biotech-like units, based in Denmark, the USA and the UK, operate as satellites to Novo Nordisk’s central R&D function and drive innovation in prioritised fields such as translational cardio-metabolic research and stem cell research. Working in a highly agile manner, outside of the usual governance structures, they are largely free of most corporate formalities and control – so they can dis- cover, enable and accelerate concepts and projects that will expand and diversify our pipeline with disruptive medicines. • Novo Nordisk’s 'Essentials' 1 We create value by having a patient centred business approach. 2 We set ambitious goals and strive for excellence. 3 We are accountable for our financial, environmental and social performance. 4 We provide innovation to the benefit of our stakeholders. 5 We build and maintain good relations with our key stakeholders. 6 We treat everyone with respect. 7 We focus on personal perfor- mance and development. 8 We have a healthy and engaging working environment. 9 We strive for agility and simplicity in everything we do. 10 We never compromise on quality and business ethics. assurance, in adherence with international standards. Evolving our culture Novo Nordisk core capabilities provide a competitive advantage. Building on a deep disease understanding, we are a leader in chronic disease care. We have deep expertise in engineering, formulating, developing and delivering protein-based treatments. And we have the capacity for efficient large-scale production. To meet the needs of the patients we serve, we are continuously challenging ourselves to raise the innovation-bar while pursuing aspirational goals. That, in turn, demands that we change how we work – that we evolve our culture – to think bigger, strive for simplicity and be more agile in order to quickly adapt to a constantly-changing business environment. With bold ideas, the risk of failure will increase. We have to accept failure, and learn fast from them. We find inspiration from the agility and entrepreneurial mind- set in biotech start-ups. One example is the Novo Nordisk Research Centre in Seattle, USA, where we work with cutting-edge technologies in life sciences. It was initially set up in 2009 to focus on our now discon- tinued research in autoimmune diseases. Since then, the site has transitioned into type 1 diabetes, obesity, immunology, kidney disease, device research and protein and peptide engineering. Here, a diverse group of 120 employees are encouraged to work together across functions and in close collaboration with the global R&D organisations across Novo Nordisk and 40 strategic partners. The landmark development of Rybelsus®, the first ever oral GLP-1 product, is a stellar example of simplicity and agility. The submission for marketing approval of Ry- belsus® embodies the FAST concept, intro- duced in 2019 across R&D: Flexible, Agile, Simple and Transformational. The team ensured parallel rather than sequential pro- cesses without compromising on quality, following a clinical development program involving more than 9,500 patients, 10 phase 3a studies, and more than 20 clinical pharmacology studies. As a result, timelines were reduced to way below industry stan- dards, achieving approval within six months and bringing Rybelsus® faster to the market to the benefit of patients. Guided by the Novo Nordisk Way We build our business on a principled approach to always doing business in a financially, environmentally and socially responsible way, which is firmly anchored in the Articles of Association. This commit- ment is reflected in the Novo Nordisk Way, and guides how we lead a sustainable busi- ness. When we make decisions, we always keep in mind what is best in the long term for the patients we serve, our employees, the communities in which we are present and the global society we are part of. This way we seek to attend to the interests of stakeholders as well as the long-term interests of our shareholders. The goal is to avoid any negative impacts, and maximise the positive impacts we can make through our business activities. We use a unique and systematic approach called facilitation to make sure everyone lives up to the Novo Nordisk Way. It comprehensively assesses how managers and employees demonstrate our desired behaviours, our ten ‘Essentials‘. These assessments are conducted by experienced in-house experts with a broad knowledge of the business. Any issues are addressed locally, and consolidated insights are shared with Executive Management and the Board of Directors. The Novo Nordisk Way also underpins our performance management and incentive schemes. All employees are appraised against criteria for goal achievement as well as the extent to which their behaviours model the Novo Nordisk Way, as spelled out in the Essentials. We have global codes of conduct and standards to ensure that we conduct our business ethically and responsibly: to pre- vent corruption, meet our responsibility to respect human rights, safeguard health and fair employment terms for our employees as well as those of our suppliers, effective- ly manage and mitigate impacts on the environment and respect the integrity of our business partners. These practices are put into action via robust governance and Novo Nordisk Annual Report 2019Consolidated statementsGovernance Introducing Novo Nordisk Our business 11 Innovation and therapeutic focus: Innovative treatments and solutions to unmet needs In the pursuit of our purpose, we pioneer scientific breakthroughs, expand access to our medicines, and work to prevent and ultimately cure the diseases we are experts in. Chronic diseases affect hundreds of millions of people and are among the most urgent global health challenges. Left untreated, they can lead to life-threatening complications, and the burden they place on individuals, families and society is grow- ing in every part of the world. We will take part in ensuring that more people have ac- cess to diagnosis and affordable treatment options where they do not currently exist, and we continue to drive innovation in our labs that can improve life for people living with a serious chronic disease. Our innovation and therapeutic focus is leveraged by our commercial excellence. We draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. We make long-term investments in novel treat- ments and technologies, including curative stem cell-based therapies, and we contin- ually advance the development of medical devices and digital health solutions. Strengthen leadership in Diabetes care There is a need for new and improved treatments that can provide better health outcomes for people with diabetes. According to the International Diabetes Federation 463 million people worldwide are now estimated to have diabetes5, and eight out of ten live in low- and middle- income countries.6 Less than half of them are treated, and even then, only a fraction of them live a life free of diabetes-related complications. As a consequence, people with diabetes have a higher risk of dying prematurely, with an average reduction in life expectancy of eight years.7 People with diabetes have a 150% increase in risk of stroke8 and as many as 70% of people with diabetes die from atherosclerotic cardiovascular diseases.9 Without concert- ed action, it is estimated that 700 million people will have diabetes by 204510 with associated societal costs exceeding USD 1 trillion per year globally.11 We will remain the global leader for diabe- tes care and offer patient support solutions in addition to therapeutic treatment. Novo Nordisk currently holds a global diabetes market share of 29% and is growing this share, with a medium-term goal of at least one third of the market. We want to en- able people with diabetes to lead healthy lives, and we have product offerings for all types of treatment needs (see 'Product overview'). Over the next decade, we will further raise the innovation-bar for diabe- tes treatment, with the goal of normalising life with diabetes. More than half of our total sales in the diabetes care segment, insulin is still Strategic aspirations for 2025 Innovation and therapeutic focus • Further raise the innovation-bar for diabetes treatment • Develop a leading portfolio of superior treatment solutions for obesity • Strengthen and progress the Biopharm pipeline • Establish presence in Other serious chronic diseases focusing on cardiovascular disease, non-alcoholic steatohepatitis and chronic kidney disease Diabetes is associated with shorter life expectancy and lower quality of life Diabetes Life expectancy 8 years shorter7 Driven by 200% increased risk of all-cause mortality12 CVD 70% of people with diabetes die from atherosclerotic CVD9 150% increase in risk of stroke8 Organs Higher likelihood of neuropathy, retinopathy, limb amputation, cancer and cognitive dysfunction Further raise the innovation bar for diabetes treatment l e v e l Insulin GLP-1 n o i t a v o n n I Curative treatment Glucose-sensitive Insulin Once-weekly Oral GLP-1 analogue Weekly GLP-1 analogue Long-acting GLP-1 analogue Insulin analogue Native GLP-1 time Novo Nordisk Annual Report 2019Consolidated statementsGovernance Introducing Novo Nordisk Our business 12 important to Novo Nordisk, and it remains the only treatment for type 1 diabetes. We are relentlessly pursuing a cure for type 1 diabetes, and at the same time we are working to develop stem cell therapy that could be transformational. We will strengthen our leading position within insulin and gain market share with our current portfolio of next-generation insulin products. Meanwhile, in our inno- vation pipeline we continue to focus on delivering improved glucose control, but we also target diabetes-related complica- tions. We are researching glucose sensitive insulins and cardio-protective insulins. With our two recent GLP-1 products, Ozempic® and Rybelsus®, we want to redefine type 2 diabetes treatment. Our intention is to position Rybelsus® as the preferred tablet, and Ozempic® as the pre- ferred injectable GLP-1 for the treatment of type 2 diabetes. We are at the forefront of innovation in the GLP-1 class and orally administered delivery devices and are pursuing several therapeu- tic opportunities with semaglutide. Our digital health initiatives, which include connected devices and digital solutions, also aim to improve health outcomes for patients. Not only will these tools aim to make it easier for patients to manage their treatment and bring them in better control; this will potentially allow for data capture that can document adherence patterns as well as short and long-term benefits of our treatments. Strengthen treatment options in Obesity care Around 650 million adults live with obesi- ty13 and this number is expected to grow to more than one billion by 2025.14 In ad- dition, 120 million children have obesity.15 People with obesity are at an increased risk of developing several comorbidities that are life-threatening and costly for society. From a socioeconomic perspective, obesity is one of the biggest disease burdens, with its global economic impact estimated at USD 2 trillion annually.16 Still, obesity is not widely recognised as a disease that may require medical treat- ment. Today, around 15 million people use anti-obesity medication.18 Few medications exist, leaving a significant opportunity for Novo Nordisk as a market leader for anti- obesity medication. We aim to develop a leading portfolio of treatment solutions. We are committed to expanding access to obesity care and helping patients lead healthy lives. The first step is to change how the world sees people with obesity and make obesity a healthcare priority. We are determined to combat the stigma and biases associated with obesity. We fight for better recognition of obesity as a treatable disease, taking a holistic approach. We aim to help a wider number of people, by partnering with professional associations and other stakeholders. In this effort, we need to engage with payers and educate healthcare professionals, encourage people with obesity to seek treatment, and de- velop educational programmes and open research initiatives. We support this development with preven- tive interventions, commercial execution and pipeline research progress – developing a leading portfolio of superior treatment solutions and securing broad availability of treatments for people with obesity. Sax- enda®, currently available in 46 countries, addresses a global unmet need for medical weight management. Over the next few years, we will make Saxenda® available to more people in more countries. We are working to develop new anti-obe- sity medications based on semaglutide. We are awaiting the results of our pivotal phase 3a clinical development programme, STEP, which investigates injectable semaglutide for the treatment of obesity. Meanwhile, we are gathering evidence on how obesity management can lead to sustainable and relevant health, economic and societal outcomes. Secure a leading position in Biopharm Our Biopharm business is a strong speciality care unit that encompasses rare blood and rare endocrine disorders, both areas of significant unmet medical need. While Biopharm’s performance has been resilient and robust the future is not straightforward, due to intense competi- tion and slower growth in the haemophilia and growth hormone markets. Therefore, we are expanding our focus to shape Biopharm for leadership in rare blood disorders and rare endocrine disorders. In the near term the way we will be suc- cessful is by working towards The global burden of obesity 650 million adults have obesity13 120 million children have obesity15 3.4 million deaths were caused by obesity in 201017 2 trillion US dollars in annual global cost of obesity16 Develop a leading portfolio of superior treatment solutions for obesity Launched Saxenda® Phase 3 Semaglutide Obesity Phase 2 AM833 Phase 1 PYY 1875 Tri-agonist GG-co-agonist LA-GDF15 AM833+Sema % 5 10 15 20 25 30 Today´s available medication Treatment gap Bariatric surgery Weight loss over time Strengthen and progress the Biopharm pipeline a i l i h p o m e a h n i n o i t a v o n n I Curative therapy Non-invasive therapy Mim8 Concizumab Esperoct® Refixia® NovoEight® NovoThirteen® NovoSeven® 1986 today future Novo Nordisk Annual Report 2019Consolidated statementsGovernance Introducing Novo Nordisk Our business 13 Establish presence in Other serious chronic diseases CVD CKD NASH Stem Cells developing and delivering faster and more front-loaded launches, in more markets. Additionally, we will strengthen our Bio- pharm platform by reinvigorating our R&D efforts and utilising the full range of the technology platforms at our disposal, as well as pursuing external opportunties. Within rare blood disorders, we are well-positioned with a broad product port- folio in haemophilia. Our legacy recombi- nant product, NovoSeven®, remains resilient in a competitive market, and with our latest, long-acting products, Esperoct® and Refixia®, we are expanding our offering for patients with Haemophilia A, Haemophilia B and rare bleeding disorders. In 2019, we launched Esperoct® and are accelerating our launches to new markets so that many more patients can benefit from this extend- ed half-life factor VIII therapy. We also succeeded in including the use of automat- ed infusion pumps in the European label for NovoSeven®, a testimony to the strong life cycle management of our legacy products. We will accelerate innovation by leveraging all Novo Nordisk R&D technology platforms – using the full spectrum from stem cell research to formulation and encapsula- tion – to expand our pipeline. In 2019, we initiated phase 3 clinical trials with concizumab for Haemophilia A and B with and without inhibitors. We are also about to begin phase 1 clinical trials with our next-generation recombinant factor VIII, Mim8, a bispecific antibody for subcutane- ous prophylactic treatment in people with haemophilia A. Outside of haemophilia we are conducting phase 1 trials with EPI01 in sickle cell disease. We will look for external assets as well. By joining forces with bluebird bio in next-generation genome editing, we aim to offer a potentially curative treatment for children and adults with haemophilia A. Within rare endocrine disorders, we will maintain our leading position in the growth hormone segment by offering transforma- tive treatment options. We will continue to explore innovation through all Novo Nordisk R&D platforms. We will build on the market-leading quality of our devices, support increased rates of diagnosis, and continue to work towards bringing somapacitan, our next-generation product intended for once-weekly treatment, to market to treat growth hormone disorders. Shifting the treatment paradigm from a daily to a weekly injection has the poten- tial to significantly relieve the treatment burden for people with growth hormone deficiencies and may increase adherence and efficacy. Establish presence in other serious chronic diseases Finally, we are working to establish our presence in other serious chronic diseases such as cardiovascular diseases (CVD), non-alcoholic steatohepatitis (NASH) and chronic kidney disease (CKD). NASH is a progressed stage of non- alcoholic fatty liver disease that affects an estimated 30 million people in the US, Europe and Japan and for which there are no approved treatments. NASH is a common comorbidity of diabetes and obesity; 80% of diagnosed NASH patients live with obesity19, while 35% live with type 2 diabetes.20 We are still exploring the potential of semaglutide to offer people with NASH better control over their disease as a stand-alone therapy and as a combi- nation product together with our partner, Gilead, a global pharmaceutical company specialising in liver diseases. We are also exploring therapies for treat- ment of cardiovascular diseases. Some of our GLP-1 products reduce the risk of car- diovascular disease and are also currently recommended for the treatment of type 2 diabetes for established cardiovascular disease. Oral semaglutide is being further investigated in cardiovascular outcomes trials and more early-stage projects are in the pipeline. Multiple other serious chronic diseases represent vast unmet medical needs that are waiting to be defeated. We believe we can use our innovation capabilities to meet these. We will build a competitive pipeline and leverage our scientific leadership to broaden and widen our portfolio as we expand into adjacent disease areas. As in other therapy areas, we will nurture partnerships and relationships across our field force and R&D with healthcare professionals and other stakeholders. New technologies, including stem cell-based therapies, will help this expansion into new therapeutic areas such as Parkinson’s disease, dry age-related macular degenera- tion, and chronic heart failure. Forming the right strategic alliances and transforming the way we deliver innovation will help us achieve our aspirations in this area. • Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo Nordisk Our business Governance Consolidated statements 1414 Pipeline overview Diabetes care Project Rybelsus® NN9924 Anti-IL-21 GLP-1 T1D NN9828 Insulin icodec (LAI287) NN1436 Insulin 965 NN1965 Icosema (LAISema) NN1535 Obesity care Semaglutide Obesity NN9536 AM833 NN9838 AM833 and semaglutide NN9838 LA-GDF15 NN9215 GG-co-agonist 1177 NN9277 PYY1875 NN9775 Tri-agonist 1706 NN9423 Haemophilia Concizumab NN7415 Eclipse NN7533 Mim8 NN7769 Growth disorder Indication Description Phase Type 2 diabetes A long-acting oral GLP-1 analogue intended for once-daily oral treatment. Type 1 diabetes A beta-cell preservation treatment intended for adults who are newly diagnosed with type 1 diabetes. Type 1 and 2 diabetes A long-acting basal insulin analogue intended for once-weekly treatment. Type 1 and 2 diabetes A novel basal insulin analogue intended for once-daily treatment. Type 2 diabetes Combination of the GLP-1 analogue semaglutide and the long-acting basal insulin icodec intended for once-weekly treatment. Obesity Obesity Obesity Obesity Obesity Obesity Obesity A long-acting GLP-1 analogue intended for once-weekly treatment. A novel long-acting amylin analogue intended for once-weekly treatment. A combination of the novel amylin analogue and the GLP-1 analogue semaglutide intended for once-weekly treatment. A long-acting GDF15 analogue intended for appetite regulation leading to weight loss. A glucagon and GLP-1 receptor co-agonist intended for once-weekly treatment. A novel analogue of the appetite-regulating hormone, PYY, intended for once weekly treatment. A novel tri-agonist of the human GIP, GLP-1 and glucagon receptors intended for once-daily treatment. Haemophilia A and B with or without inhibitors A monoclonal antibody against tissue factor pathway inhibitor intended for subcutaneous prophylaxis treatment. Sickle cell disease and beta thalassaemia An oral combination treatment of sickle cell disease. Project is developed in collaboration with EpiDestiny. Haemophilia A with or without inhibitors A next-generation FVIII mimetic bispecific antibody for subcutaneous prophylaxis of haemophilia A regardless of inhibitor status. Combined phase 1/2. Somapacitan AGHD NN8640 Adult growth hormone deficiency A long-acting human growth hormone analogue intended for once-weekly subcutaneous administration in adults. Somapacitan GHD NN8640 Growth hormone deficiency A long-acting human growth hormone analogue intended for once-weekly subcutaneous administration in children. NASH (non-alcoholic steatohepatitis) Semaglutide NN9931 Gilead:Sema combo NN9931 NASH NASH Cardiovascular disease A long-acting GLP-1 analogue for treatment of NASH. A GLP-1 analogue, semaglutide, in combination with an FXR agonist, cilofexor, an ACC inhibitor, firsocostat, or the three in combination. The project is developed in collaboration with Gilead. PCSK9i peptide NN6434 CVD A long-acting PCSK9 inhibitor for subcutaneous treatment. 9 9 1 1 0 0 2 2 t t r r o o p p e e R R l l a a u u n n n n A A k k s s i i d d r r o o N N o o v v o o N N Novo Nordisk Annual Report 2019Consolidated statementsGovernance Introducing Novo Nordisk Our business Governance Consolidated statements 1515 2020 expected key milestones Oral semaglutide Regulatory decision in Japan AM833 Semaglutide Semaglutide Ozempic® Somapacitan Phase 2 results from Amylin in obesity Phase 2 results for semaglutide in NASH Phase 3 results for semaglutide in obesity Phase 3 results for 2 mg Ozempic® Regulatory decision for AGHD in the US and the EU Patent status for marketed products The patent expiry dates for the product portfolio are shown in the table below. The dates provided are for expiry in the US, Germany, China and Japan of patents on the active ingredient, unless otherwise indicated, and include extensions of patent term, when applicable. For several products, in addition to the active ingredient patent, Novo Nordisk holds other patents on manufacturing processes, formulations or uses that may be relevant for exclusivity beyond the expiration of the active ingredient patent. Furthermore, regulatory data protection and/ or orphan exclusivity may apply. Key marketed products in main markets (active ingredients) USA China Japan Germany Diabetes: Human insulin NovoRapid® (NovoLog®) NovoMix® 30 (NovoLog® Mix 70/30) NovoNorm® (Prandin®) Levemir® Victoza® Tresiba® Ryzodeg® Xultophy® Fiasp® Ozempic® Rybelsus® Obesity: Saxenda® Haemophilia, growth disorders and hormone replacement therapy: Norditropin® (Norditropin® SimpleXx®) MacrilenTM NovoSeven® NovoEight® NovoThirteen® (TRETTEN®) Refixia® (REBINYN®) Esperoct® Vagifem® 10 mcg Expired Expired Expired Expired Expired 2023 2029 2029 2029 (2030)3 20311 20311,7 Expired Expired Expired Expired Expired Expired 2024 2024 2024 (2030)3 2026 20267 Expired Expired Expired Expired Expired 2022 2027 20242 20242 (2030)3 20311 20311,7 Expired Expired Expired Expired Expired 2023 2028 2028 2028 (2030)3 2031 20317 2023 Expired Expired 2023 Expired 20278 Expired Expired Expired N/A N/A N/A Expired4 Expired4 Expired4 Expired4 N/A 2021 20281 20321 20225,6 N/A N/A 2022 2029 N/A N/A N/A Expired Expired 20271 20341 20215 20271 20341 N/A 1. Current estimates. 2. Patent term extension until 2027 may apply. 3. Formulation patent; active ingredient patent has expired. 4. Room temperature-stable formulation patent until 2023 in China, Germany and Japan and until 2025 in the US. 5. Patent covers low-dose treatment regimen. 6. Licensed to several generic manufacturers from October 2016. 7. Tablet formulation and once-daily treatment regimen are protected by additional patents expiring in 2031-2034. 8. Protects method of use and kits of parts. 9 9 1 1 0 0 2 2 t t r r o o p p e e R R l l a a u u n n n n A A k k s s i i d d r r o o N N o o v v o o N N Novo Nordisk Annual Report 2019Consolidated statementsGovernance Introducing Novo Nordisk Our business 16 Commercial execution: International Operations: Building a sustainable platform for accelerated growth Our International Operations (IO) unit covers 190 countries and 95% of the world’s population. Around 430 million people are liv- ing with diabetes in these countries21 and an estimated 570 million live with obesity.22 The unmet needs are huge, and Novo Nordisk is gearing up for growth, with a strategic aspiration of 6-10% annual growth in sales towards 2025. Across IO, the number of people with diabetes is rising fast. As economies grow, so too does the level of access to different types of diabetes treatment. In a business unit as broad as IO, this creates a high degree of complexity due to different levels of security, economic development and political situation in the respective regions. The fastest increase in type 2 diabetes is seen in emerging economies, where rapid urbanisation leads to more sedentary lifestyles and less healthy diets. Type 2 dia- betes in younger people is also a significant global trend that will increasingly affect the way we operate commercially. With type 2 diabetes so closely linked to obesity, these trends are also informing our obesity strategy. As the number of younger people with obesity grows, so does the number of instances of diabetes in people in their 30s and 40s. At this age, these are primarily working people, which means that doctors need to give them different guidance to what they might tell a retiree. A market fit approach To ensure as many as possible of these people can access our treatments, we tailor our strategic approach to the specific needs of each market. We have a diverse port- folio of products that enables us to have suitable offers for all situations – we call that our market fit approach. For example, our range of basal insulin includes human insulin, modern insulin and next-generation insulin – providing us with a solid base as a leader in diabetes care. At the same time, we also offer GLP-1 products that we expect will drive future growth in Diabetes and Obesity care. There are local market considerations, too. In Latin America, for example, we are seeing an increase in healthcare spending. However, this is counterbalanced by high political risks – for example, high inflation rates in Venezuela and Argentina. In China, meanwhile, a huge ageing population points to growing unmet medical needs in the future. As a result, healthcare is high on the Chinese govern- ment’s agenda through general reform and programmes such as Healthy China 2030. Across IO, Novo Nordisk holds the leading diabetes value market share in most countries. In markets where this is not the case, we want to grow our share. In order to respond to the diverse conditions and Strategic aspirations for 2025 Commercial execution • Strengthen Diabetes care leadership – aim at a global value market share of more than 1/3 • Strengthen Obesity care leader- ship and double current sales¹ • Secure a sustained growth outlook for Biopharm 1. Based on 2019 sales trends across our geographic regions and therapeutic focus areas, we constantly eval- uate our business decisions and fine-tune our strategy to make sure we meet local market needs and challenges. By combining this market fit approach with the business ethics enshrined in the Novo Nordisk Way, we believe we have the framework we need to achieve our commercial goals sustainably. Growing fast and sustainably 2019 demonstrated that our commercial model is working. We accelerated our sales growth to 11% at CER in 2019 compared to around 5% at CER historically. This has been enabled by: • Changing demographics across geogra- phies that lead to significant increase in unmet medical needs • Our market fit approach – where our re- gional teams develop product strategies fit for their areas • Our portfolio of products Looking ahead, our ambition is to drive growth by establishing leadership in the basal insulin space, accelerating the growth of the GLP-1 market, and expanding the obesity market. We want to broaden access to diabetes treatments – and make treatment more affordable. This is where we can strengthen our market leadership in basal insulin. Last year, Tresiba® became available to patients in France, Germany and China, and we are already beginning to see more patients benefiting from this, our flagship next-generation basal insulin. In the next few years, we expect to launch Tresiba® and Xultophy® in several other countries where new-generation insulin are not available today. Novo Nordisk Annual Report 2019Consolidated statementsGovernance Introducing Novo Nordisk Our business Governance 17 Whilst we remain value leaders in the GLP-1 market, we are facing increased competitive pressures and a decline in our market share in some IO regions. This year, we focused on turning this trend around. We are leveraging the label update for Victoza® achieved on the basis of results from the LEADER trial, which showed that liraglutide is associated with significant cardiovascular risk reduction in people with type 2 diabetes. Meanwhile, we are rolling out Ozempic® as fast as we can wherever there is a market opportunity. This is helping us to increase our share of market growth, bringing us closer to realising our medium-term ambition of more than 50%. We are also planning launches of the first and only GLP-1 in a tablet, Rybelsus®, in the same timeframe. Because Rybelsus® will follow a route driven by general prac- titioners and patient demands it is likely to put pressure on our field force capacities, as our representatives will have to reach far more healthcare professionals and have less time with each. We are mitigating this by exploring partnerships that can give us extra and flexible field force resources when we need them. To maximise the opportunity this presents, we have agreed to enter a co-promotion partnership with the major pharmaceu- tical firm MSD, whose vast experience in marketing oral antidiabetics (OADs) to Jap- anese diabetes specialists is key our efforts to bring the treatment into the hands of as many people as possible. In Obesity care, we are investing to expand the market by working with a variety of stakeholders including policymakers to ensure that it is more widely recognised as a disease that can be tackled through medical intervention. Saxenda® is already delivering value here, with around 72% of market growth over the last year. We plan for several more launches between 2020 and 2022, at which point we hope to be ready to introduce semaglutide for obesity into this fast-growing therapy area. with the government in China to provide digital healthcare solutions. One example is WeDoctor – a nationwide medical consult- ing platform connecting an astounding 172 million patients and 300,000 doctors. This platform allows patients and doctors to stay in touch via a user-friendly mobile app. But when it comes to delivering better treatments to people living with diabetes, obesity or other chronic diseases, commer- cial innovation can be just as important as product innovation. This is why we constantly assess and - if necessary - rethink the way we execute our strategy. This year, for example, we created separate teams for GLP-1, insulin and Biopharm, respectively, to give each area more focus and decision- making autonomy. • In Biopharm we will focus on expanding our footprint in haemophilia A and B. Hae- mophilia A constitutes the largest patient population in haemophilia and our ability to secure a leading position in rare blood disorders will be driven by our success in growing sales with NovoEight® and Esperoct®. Furthermore, we are confident that an increasing number of patients living with haemophilia B will choose Refixia®. Combining research and commercial innovation We believe Rybelsus® – our semaglu- tide-based oral diabetes medicine – will transform the lives of millions of people across IO by helping people to manage their disease. Our aim, therefore, is to secure broad access to this world-first innovation, and we are already taking steps to ensure this ahead of the product’s first IO launch. We are also capitalising on innovation developments in different regions. For example, in China, the government’s push for innovation in healthcare is helping us broaden and deepen our relationships there. The Chinese government is enabling quicker clinical review and encouraging the use of generics to drive more cost- efficiency – meaning we will have shorter windows of opportunity and shorter product lifecycles. To help Chinese patients better manage their diabetes, we are working closely Novo Nordisk diabetes value market share and share of growth in International Operations NN share of growth NN market share % 25 20 15 10 5 0 23.1% 7.4% Nov 2016 22.0% 20.7% Nov 2019 Novo Nordisk Annual Report 2019Consolidated statementsIntroducing Novo Nordisk Our business 18 Commercial execution: North America Operations: Ready for growth in a challenging business environment Around half of our global sales are generated in the US, making our North America operations – the US and Canada – a critical compo- nent of our business. We are successfully transforming our business by utilising the potential of our innovative product offerings and we have strengthened our commitment to our social responsibility to make insulin available to all patients. More than 30 million people in the US live with diabetes.23 Of those, millions remain undiagnosed and are not getting proper treatment. The numbers are just as alarming in obesity – if not more so. According the Centers for Disease Control & Prevention, more than 93.3 million people were living with obesity in 201624, costing the US healthcare system 1.72 trillion US dollars annually.25 The unmet needs are beyond question and have brought about new dynamics in the marketplace. Payer consolidation puts pres- sure on prices of medicines, government interventions aim to address structural barriers to effective care, healthcare is undergoing a digital transformation, and across all of these looms the urgency of providing affordable care for uninsured and underinsured people like those in high-de- ductible healthcare plans. Successfully adapting to the new busi- ness environment In this challenging business environment, Novo Nordisk is going through a historic transition to remain a market leader and secure future growth, contributing to the company’s overall goal to achieve a global diabetes value market share of more than one-third. Towards 2022, it is expected that around 70% of sales will be from inno- vative new products, while the remaining 30% will be legacy products. To help us reach our medium-term goals, we have a clear growth strategy centred around bringing innovative new products to mar- ket – and increasing our market share. Our GLP-1 offerings provide improved treatment for broader segments of pa- tients. Meanwhile, we continue to deliver insulins and grow the volume amidst pric- ing challenges. We are building the market for obesity care, enhancing growth oppor- tunities for our innovative products. And we remain committed to serving patients with haemophilia and growth disorders. Reaching significant milestones We have reached three very important milestones, all of which emphasise the strength of our existing – and future – GLP- 1 franchise: Strategic aspirations for 2025 Commercial execution • Strengthen Diabetes care leadership – aim at a global value market share of more than 1/3 • Strengthen Obesity care leader- ship and double current sales¹ • Secure a sustained growth outlook for Biopharm 1. Based on 2019 sales • Rybelsus®, our oral semaglutide medi- cine for type 2 diabetes, was approved by the US Food & Drug Administration (FDA) in September 2019, with the first prescriptions written the following month, • In January 2020, Ozempic® our once-weekly type 2 diabetes medicine, was approved in the US for cardiovascu- lar risk reduction in people with type 2 diabetes and established cardiovascular disease. • Ozempic® reached global blockbuster status in September 2019, with the bulk of sales generated in the US. Innovating for diabetes leadership Our ultimate goal for diabetes treatment is to help patients live as full and healthy lives as possible. We want to change how the disease is treated and how it is viewed, offering products that meet medical needs and match patients’ lifestyles. We built our position as the world’s larg- est insulin producer through innovative injectable drugs. Going forward, we will transform the market with our indus- try-first GLP-1 in a tablet, Rybelsus®. In the US, around 70% of diabetes prescriptions are for oral treatments, and so far none are from the highly effective GLP-1 class which we specialise in. We are confident that the launch of Rybelsus® will change this. But our focus is not only on portfolio inno- vation; we also need to improve access and play a key role in prevention. This means effecting change everywhere that influenc- es, or is influenced by the disease – includ- ing research, education, public policy, as well as humanitarian and outreach efforts. Championing affordability for patients in a complex healthcare system Tackling the structural challenges in Novo Nordisk Annual Report 2019Consolidated statementsGovernance Introducing Novo Nordisk Our business Governance 19 In a few years, Novo Nordisk USA aspire to have 2 new blockbusters on the market notably increase the number of patients treated turned around approx. 70% of sales (from 2015) stakeholders to advocate for the Treat and Reduce Obesity Act, a vital piece of legislation that will improve access to care for people with obesity. The Act addresses policy barriers to obesity care and cover- age, including access to pharmacotherapy. All of these measures are helping shift social perspectives towards recognition of obesity as a chronic disease and empower people living with obesity in the US to seek and receive the respectful, complete care they deserve. Promising prospects in biopharm Haemophilia remains a key focus in our biopharm business. We want to help patients living with this disease manage it better so they can lead healthier and more fulfilling lives. The FDA approval of Esperoct® in Febru- ary 2019 and the Breakthrough Therapy Designation for concizumab for prophylaxis treatment in people with haemophilia B with inhibitors were important milestones in the fight against this serious chronic disease. In our growth disorders business, we are awaiting the response on somapacitan – a new long-acting growth hormone for treatment in adults with growth hormone deficiency, which we submitted for the US FDA regulatory approval in September 2019. • the US healthcare system calls for long- term reform changes to make sustainable and meaningful affordability a reality. We are doing our part and updating our support offerings, engaging with multiple stakeholders. We acknowledge the role of list prices, but more needs to be done to improve how insurance benefits cover essential medicines, especially through high deductible health plans. See our offerings to provide affordable insulin in 'Leading a sustainable business'. Advocating for stronger obesity focus and policies We have a clear ambition to offer medical treatment for more people with obesity and expect to double the sales of our obesity products globally by 2025. In the US and Canada, we work to bring superior treatments to market, and engage with key stakeholders and policymakers to make obesity a healthcare priority. The launch of our Changing Obesity™ aspiration in January 2019 underscores our commitment to change how the world sees, treats and works to prevent obesity. In this effort we work with partners from both public and private sectors. A case in point is our contribution – via an educational grant – to the establishment of the US Obesity Medicine Clinical Fellow- ship Development Program. Thanks to this grant, the Obesity Society and the Obesity Medicine Association are working to in- crease the number of physicians with spe- cialised training in caring for and treating patients with obesity and its complications. In 2019, seven new Obesity Fellowships were awarded. We also invested considerable time and resources in and joined forces with key Novo Nordisk diabetes value market share and share of growth in North America Operations NN share of growth NN market share % 50 40 30 20 10 0 28.5% 22.9% Nov 2016 37.4% 31.1% Nov 2019 Novo Nordisk Annual Report 2019Consolidated statementsIntroducing Novo Nordisk Our business Governance 20 Financials: 2019 performance and 2020 outlook Financial performance Novo Nordisk's 2019 performance for sales measured at constant exchange rates (CER) exceed the outlook provided in February 2019, while operating profit measured at CER was within the range provided in Feb- ruary 2019. The free cash flow marginally exceeded the outlook provided in February 2019, while the tax rate was lower follow- ing a positive impact from non-recurring changes to deferred tax assets. Capital expenditure was broadly in line with the guidance provided in February 2019. Geographic sales development Sales increased by 9% measured in Danish kroner and by 6% at CER to DKK 122,021 million in 2019. Sales in International Operations increased by 12% measured in Danish kroner and by 11% at CER. Sales in North America Operations increased by 6% measured in Danish kroner and by 1% at CER. The sales growth is in line with the lat- est guidance of '5-6% sales growth at CER' provided in connection with the announce- ment in November 2019 for the financial results of the first nine months of 2019. Sales development across therapeutic areas Sales growth in 2019 was 9% measured in Danish kroner and 6% at CER was driven by solid growth across all therapy areas with Diabetes care sales growth of 4% (CER), Obesity care sales growth of 42% (CER) and Biopharm sales growth of 4% (CER). Diabetes care, sales development Sales in Diabetes care increased by 8% measured in Danish kroner and by 4% at CER to DKK 97,161 million driven by solid GLP-1 growth, partly offset by declining insulin sales. Novo Nordisk has improved its global diabetes value market share over the last 12 months from 27.8% to 28.6%, driven by improved global insulin market share and growth of the GLP-1 segment, reflecting an expansion of the diabetes value market share in North America Operations and a stabilisation of the value market share in International Operations. In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from November 2019 and November 2018 provided by the inde- pendent data provider IQVIA. Insulin Sales of insulin remained unchanged in Danish kroner and decreased by 3% at CER to DKK 59,693 million. The decreased sales measured at CER were driven by declining sales in the USA, partly offset by increased sales in International Operations. Sales of long-acting insulin remained unchanged in Danish kroner and decreased by 4% at CER to DKK 20,776 million. Novo Nordisk has improved its global volume market share in the long-acting insulin seg- ment from 31.6% to 32.4% in the last 12 months. The decreased sales measured at CER were driven by declining Levemir® sales, partly offset by a positive impact from Tresi- ba® and Xultophy®. Tresiba® has now been launched in 86 countries, while Xultophy® has now been launched in 37 countries. Sales of premix insulin increased by 4% measured in Danish kroner and by 2% at CER to DKK 10,578 million. Novo Nordisk is market leader in the premix insulin segment with a global volume market share of 63.9%, which has been broadly unchanged over the past 12 months. The increased sales were driven by increased sales of Ryzodeg® NovoMix® sales. Ryzodeg® has now been launched in 30 countries. , partly offset by declining Sales of fast-acting insulin remained un- changed in Danish kroner and decreased by 3% at CER to DKK 19,303 million. Novo Nordisk is market leader in the fast-acting insulin segment with a global volume market share of 50.7%, which has been broadly unchanged over the past 12 months. The decreasing sales measured at CER were driven by declining sales of NovoRapid®, partly offset by a positive impact from Fiasp®. Fiasp® has now been launched in 33 countries. Strategic aspirations for 2025 Financials • Deliver solid sales and operating profit growth – Deliver 6-10% sales growth in International Operations – Transform 70% of sales in the USA2 • Drive operational efficiencies across the value chain to enable investments in future growth assets • Deliver free cash flow to enable attractive capital allocation to shareholders 2. From 2015 to 2022 Sales growth In DKK as reported At constant exchange rates % 25 20 15 10 5 0 2015 2016 2017 2018 2019 Share of growth at constant exchange rates Region Europe Region AAMEO Region China Region Japan & Korea Region Latin America North America Operations % 100 80 60 40 20 0 2015 2016 2017* 2018* 2019 * In 2017, North America contributed -5% to the total growth * In 2018, Japan & Korea contributed -2% to the total growth Novo Nordisk Annual Report 2019Consolidated statements Introducing Novo Nordisk Our business Governance 21 Sales by segment Biopharm Diabetes and Obesity care DKK billion 125 100 75 50 25 0 2015 2016 2017 2018 2019 Operating profit Operating profit margin (left) Operating profit (right) DKK billion 60 50 40 30 20 10 0 2015 2016 2017 2018 2019 % 60 50 40 30 20 10 0 Sales of human insulin decreased by 2% measured in Danish kroner and by 5% at CER to DKK 9,036 million. GLP-1 therapy for type 2 diabetes Sales of GLP-1 products for type 2 diabe- tes (Victoza®, Ozempic® and Rybelsus®) increased by 27% measured in Danish kroner and by 22% at CER to DKK 33,221 million. Sales growth was driven by both North America Operations and Inter- national Operations. Sales of Ozempic® were DKK 11,237 million and Ozempic® has now been launched in 26 countries in North America Operations, Region Europe, Region Latin America and Region AAMEO. The GLP-1 segment’s value share of the to- tal diabetes market has increased to 18.0% compared with 14.4% 12 months ago. Novo Nordisk continues to be the global market leader in the GLP-1 segment with a 47.5% value market share. Obesity care, sales development Sales of Saxenda® increased by 47% measured in Danish kroner and by 42% at CER to DKK 5,679 million. Sales growth of Saxenda® was driven by both International Operations and North America Operations. Saxenda® has now been launched in 46 countries. Novo Nordisk currently has a value market share of 56% of the global obesity prescription drug market. Biopharm Biopharm, sales development Sales of biopharm products increased by 7% measured in Danish kroner and by 4% at CER to DKK 19,181 million. The sales development was driven by sales growth in both operating units as well as across both franchises: Haemophilia and Growth disorders. Sales growth in International Operations was driven by Region Latin America, Region AAMEO, Region China and Region Japan & Korea. Haemophilia Sales of haemophilia products increased by 7% measured in Danish kroner and by 4% at CER to DKK 10,281 million. The in- creasing sales were driven by the continued global roll-out of Refixia® and NovoEight®. Novo Nordisk continues to expand its broad global haemophilia presence. Sales of NovoSeven® increased by 3% measured in Danish kroner, and remained unchanged at CER, to DKK 8,119 million, reflecting the solid position of NovoSeven® as a haemostatic agent in critical treatment settings and a wide range of labelled indi- cations in an increasingly competitive envi- ronment. The sales development is driven by increased sales in Region Latin America, Region AAMEO and Region China as well as stable sales in North America Operations offset by declining sales in Region Europe and Region Japan & Korea. Sales of NovoEight® increased by 13% measured in Danish kroner and by 10% at CER to DKK 1,525 million. Sales growth was driven by Region Latin America, Region AAMEO, Region Europe and North America Operations. NovoEight® has now been launched in 52 countries. Sales of Refixia® increased to DKK 382 million. Sales growth was driven by the product launches in Region Europe, Region Japan & Korea and North America Operations. Refixia® has now been launched in 16 countries. Esperoct® has now been launched in nine countries and the initial feedback from patients and physicians is encouraging. Growth disorders (Norditropin®) Sales of growth disorder products increased by 6% measured in Danish kroner and by 2% at CER to DKK 7,275 million. The increasing sales were driven by Internation- al Operations increasing by 3% at CER and by North America Operations increasing by 2% at CER. Novo Nordisk is the leading company in the global human growth disorder market with a market share mea- sured in value of around 33% driven by new indications and the introduction of the next-generation device. Development in costs and operating profit The cost of goods sold increased by 14% measured in Danish kroner and by 12% at CER to DKK 20,088 million, resulting in a gross margin of 83.5% measured in Danish kroner, compared with 84.2% in 2018. The decrease in gross margin reflects a negative impact from lower realised prices in the USA and impairment of intangible assets, partly countered by a positive product mix driven by increased GLP-1 sales and a positive currency impact of 0.3 percentage point. Sales and distribution costs increased by 8% measured in Danish kroner and by 6% at CER to DKK 31,823 million. The increase in sales and distribution costs was Novo Nordisk Annual Report 2019Consolidated statementsIntroducing Novo Nordisk Our business Governance 22 Free cash flow DKK billion 40 30 20 10 0 2015 2016 2017 2018 2019 line with the latest guidance of 'around DKK 9 billion'. Capital expenditure was primarily related to investments in a new production facility for diabetes active phar- maceutical ingredients in Clayton, North Carolina, USA, expansion of production facilities in Kalundborg, Denmark, expan- sion of production facilities in Chartres, France and a new diabetes filling capacity in Hillerød, Denmark. Free cash flow was DKK 34.5 billion com- pared with DKK 32.5 billion in 2018, which is in line with the latest guidance of 'DKK 31-35 billion'. The increase of 6% com- pared with 2018 primarily reflects increased cash from operating activities driven by the timing of rebate payments in the USA. driven by International Operations reflect- ing resource allocation to growth markets and promotional activities for Victoza® and launch activities for Ozempic®, promotional activities for insulin, particularly in China, as well as promotional activities for the continued roll-out of Saxenda®. In the USA, promotional activities are focusing on Ozempic® and Saxenda® as well as launch activities for Rybelsus®, partly offset by lower promotional spend related to insulin. Research and development costs decreased by 4% measured in Danish kroner and by 6% at CER to DKK 14,220 million, posi- tively impacted by reversal of write-downs of prelaunch inventory in first quarter of 2019 following the filing of Rybelsus® to the US FDA, severance costs in second half of 2018 and the expense of the priority review voucher for Rybelsus® in fourth quarter of 2018 partly offset by impair- ment of intangible assets in 2019. The underlying increase in R&D costs is driven by increased costs for the semaglutide in obesity clinical programmes STEP and SELECT, the ramp-up of the SOUL cardio- vascular outcomes trial with Rybelsus® as well as increased costs for the semaglutide NASH development activities, partly offset by the completion of the Rybelsus® phase 3a development programme and the com- pletion of the head-to-head study between Tresiba® and insulin glargine U300. Administration costs increased by 2% mea- sured in Danish kroner and by 1% at CER to DKK 4,007 million, reflecting increased legal costs while spend across administra- tive areas was broadly unchanged. Other operating income (net) was DKK 600 million compared with DKK 1,152 million in 2018. The decline in Other operating income (net) in 2019 compared with 2018 reflects non-recurring income in 2018 and decrease in income from licence agreements. Operating profit increased by 11% in Danish kroner and by 6% at CER to DKK 52,483 million, which is in line with the latest guidance for operating profit growth measured at CER of '4-6%' in 2019. Financial items (net) and tax Financial items (net) showed a net loss of DKK 3,930 million compared with a net gain of DKK 367 million in 2018. The re- ported net financial items in 2019 is in line with the latest guidance of 'loss of around DKK 3.9 billion'. In line with Novo Nordisk’s treasury policy, the most significant foreign exchange risks for the Group have been hedged, primarily through foreign exchange forward con- tracts. The foreign exchange result was a loss of DKK 3,212 million compared with a gain of DKK 298 million in 2018. This development reflects a loss on foreign exchange hedging, especially related to the US dollar versus the Danish krone. As per the end of December 2019, a negative market value of financial contracts of approximately DKK 0.3 billion has been deferred for recognition in 2020. The effective tax rate was 19.8% in 2019 compared with an effective tax rate of 18.9% in 2018. The reported effective tax rate of 19.8% is in line with the latest guidance of a tax rate of '19-21%' for 2019. The effective tax rate for 2019 was positively impacted by minor non-recurring changes to deferred tax assets following the approval of the Swiss tax reform, while non-recurring changes in tax provisions related to settlement of international tax cases positively impacted the 2018 tax rate. Capital expenditure and free cash flow Capital expenditure for property, plant and equipment was DKK 8.9 billion compared with DKK 9.6 billion in 2018, which is in Key invoicing currencies Impact on Novo Nordisk's operating profit in the next 12 months of a 5% movement in currency Hedging period (months) USD CNY1 JPY CAD GBP DKK 1,950 million DKK 450 million DKK 150 million DKK 130 million DKK 100 million 9 7 12 9 10 1 Chinese yuan traded offshore (CNH) used as proxy when hedging Novo Nordisk’s CNY currency exposure Novo Nordisk Annual Report 2019Consolidated statementsIntroducing Novo Nordisk Our business 23 Outlook 2020 The current expectations for 2020 are summarised in the table below: Expectations are as reported, if not otherwise stated Expectations 5 February 2020 (API) production within Diabetes care and an expansion of thefilling capacity within Diabetes care. Depreciation, amortisation and impairment losses are expected to be around DKK 5 billion. The decline in depre- ciation, amortisation and impairment losses in 2020, compared with the level in 2019, reflects higher levels of impairment losses in 2019. Free cash flow is expected to be DKK 36-41 billion. All of the above expectations are based on assumptions that the global or regional economic and political environment will not significantly change business conditions for Novo Nordisk during 2020, including the potential implications from major healthcare reforms, and that the currency exchange rates, especially the US dollar, will remain at the current level versus the Danish krone. Neither does the guidance include the financial implications in case of a significant bolt-on acquisition during 2020. Furthermore, the guidance does not include any significant impact from the outbreak of coronavirus. Novo Nordisk has hedged expected net cash flows in a number of invoicing cur- rencies and, all other things being equal, movements in key invoicing currencies will impact Novo Nordisk’s operating profit as outlined in the table Key invoicing currencies. Long-term financial targets Novo Nordisk introduced four long-term financial targets in 1996 to balance short- and long-term considerations . The targets were subsequently revised and updated on several occasions, most recently in con- nection with the Annual Report for 2018 released in February 2019. With the performance in 2019, Novo Nor- disk has met its long-term financial targets comprising average operating profit growth of 5%, cash-to-earnings of 85% (3-year average) and operating profit after tax over net operating assets (OPAT/NOA) of 80%. 3% to 6% Around 1 percentage point higher than at CER 1% to 5% Around 1 percentage point higher than at CER Loss of around DKK 1.5 billion 20% to 22% Around DKK 6.5 billion Around DKK 5 billion DKK 36-41 billion activities related to the commercial priorities across the operating units including the introduction of Rybelsus® in the USA, the continued global expansion of the injectable GLP-1 diabetes franchise, the global invest- ment in building an anti-obesity market and the promotional activities for roll-out of the Biopharm portfolio. Given the current exchange rates versus the Danish krone, growth reported in DKK is expected to be 1 percentage point higher than at CER. For 2020, Novo Nordisk expects financial items (net) to amount to a loss of around DKK 1.5 billion, offsetting the positive currency impact on operating profit. The current expectation for 2020 primarily reflects losses associated with foreign exchange hedging contracts, mainly related to the US dollar and Chinese yuan versus the Danish krone. The effective tax rate for 2020 is expected to be in the range of 20-22%. Capital expenditure is expected to be around DKK 6.5 billion in 2020, primarily relating to investments in additional ca- pacity for active pharmaceutical ingredient Sales growth at CER as reported Operating profit growth at CER as reported Financial items (net) Effective tax rate Capital expenditure (PP&E) Depreciation, amortisation and impairment losses Free cash flow For 2020, sales growth is expected to be 3% to 6%, measured at CER. This guidance reflects expectations for robust performance for the GLP-1-based diabetes care products Ozempic®, Victoza® and Ry- belsus®, the obesity care product Saxenda®, the portfolio of new-generation insulin and the contribution from the biopharm prod- ucts Esperoct®, Refixia® and NovoEight®. The guidance also reflects intensifying com- petition both within Diabetes care and Bio- pharm, especially within the haemophilia inhibitor segment. Furthermore, continued pricing pressure within Diabetes care as well as expansion of already announced af- fordability initiatives, especially in the USA, are expected to impact sales development. Given the current exchange rates versus the Danish krone, growth reported in DKK is expected to be around 1 percentage point higher than at CER. For 2020, operating profit growth is expect- ed to be 1% to 5%, measured at CER. The expectation for operating profit growth pri- marily reflects the sales growth outlook and continued focus on resource allocation. Op- erating profit growth is negatively impacted by increased investments in commercial Long-term financial targets Operating profit growth at CER1 Operating profit after tax to net operating assets 98.0% 116.7% 143.2% 150.2% Cash to earnings Cash to earnings (three-year average) 88.4% 86.0% 84.2% 85.5% 105.4% 91.7% 96.4% 102.4% 1 Operating profit growth at CER for 2016 is adjusted for DKK 2,376 million from the partial divestment of associated company and DKK 449 million from the income related to the out-licensing of assets for inflammatory disorders in 2015. 2019 5.6% 2018 2.8% 2017 4.8% 2016 6.2% Average 2016 - 2019 4.9% Target 5% 80% 85% Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo Nordisk Our business 24 Novo Nordisk’s results or the accuracy of forward-looking statements in this Annual Report 2019, reference is made to the overview of risk factors in ‘Managing risks to protect value’ of this Annual Report 2019. Unless required by law, Novo Nordisk is under no duty and undertakes no obliga- tion to update or revise any forward-look- ing statement after the distribution of this Annual Report 2019, whether as a result of new information, future events or otherwise. • Strategic aspirations for 2025 To reflect the broad growth aspects of Novo Nordisk across therapy areas and geographies, the historic approach to long- term financial targets focusing on specific financial aspects is no longer sufficiently describing Novo Nordisk’s future growth outlook. Consequently, Novo Nordisk announced in connection with its Capital Markets Day in November 2019 that it is replacing the current long-term financial targets structure with a more comprehen- sive approach describing the future growth aspirations of the company under the headline: Strategic aspirations for 2025. The strategic aspirations, reflecting the sustained growth opportunities until 2025, are intended to cover future growth drivers of Novo Nordisk and thereby providing investors with an understanding of Novo Nordisk’s growth and investment opportu- nities across therapy areas and geographies. The strategic aspirations are objectives that Novo Nordisk intends to work towards and are not a projection of Novo Nordisk's financial outlook or expected growth. Novo Nordisk intends to describe how its activi- ties develop in relation to each of the four dimensions on an ongoing basis. Forward-looking statements Novo Nordisk’s reports filed with or fur- nished to the US Securities and Exchange Commission (SEC), including this statutory Annual Report 2019 and Form 20-F, which are both expected to be filed with the SEC in February 2020 in continuation of the publication of this Annual Report 2019, 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’, ‘in- tend’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking state- ments. Examples of such forward-looking statements include, but are not limited to: • statements of targets, plans, objectives or goals for future operations, includ- ing those related to Novo Nordisk’s products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto, • statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expen- ditures, dividends, capital structure, net financials and other financial measures, • statements regarding future economic performance, future actions and out- come of contingencies such as legal proceedings, and • statements regarding the assump- tions underlying or relating to such statements. In this Annual Report 2019, examples of forward-looking statements can be found under the headings '2019 Performance and 2020 outlook' and elsewhere. These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements in- volve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, includ- ing those described in this Annual Report 2019, could cause actual results to differ materially from those contemplated in any forward-looking statements. 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 fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recalls, unexpected contract breaches or terminations, gov- ernment-mandated or market-driven price decreases for Novo Nordisk’s products, in- troduction of competing products, reliance on information technology, Novo Nordisk’s ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reim- bursement, 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 main- tain a culture of compliance. For an overview of some, but not all, of the risks that could adversely affect Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo Nordisk Our business Governance 25 Research and development In 2019, we made significant prog- ress in research and development pipeline, reaching several important regulatory milestones. Key development projects are highlighted below, along with a pipeline overview of compounds in clinical develop- ment. Further details on clinical trials can be found in company announcements and press releases published by Novo Nordisk during 2019, available at novonordisk.com Diabetes care Regulatory events We submitted a New Drug Applications (NDA) to the US Food and Drug Admin- istration (FDA) for oral semaglutide, a once-daily glucacon-like peptide-1 (GLP-1) receptor agonist, as a treatment to improve glycaemic control in adults with type 2 dia- betes. This resulted in FDA approval in Sep- tember 2019, of the first GLP-1 in a tablet, Rybelsus®. The approval was based on the phase 3a PIONEER development pro- gramme, which included 9,543 adults with type 2 diabetes. We launched Rybelsus® in the US in the fourth quarter of 2019. A second NDA was submitted for oral semaglutide and a supplementary NDA (sNDA) for Ozempic® (once-weekly inject- able semaglutide), seeking approval for a separate indication for cardiovascular risk reduction in adults with type 2 diabetes. These applications are based on results from two cardiovascular outcomes trials (CVOTs) evaluating the effects of adding semaglutide or placebo to standard of care on the risk of cardiovascular events, namely, PIONEER 6 with oral semaglutide and SUSTAIN 6 with Ozempic®. On the basis of the submitted data, Ozempic® was approved in the USA for cardiovas- cular risk reduction in people with type 2 diabetes. The Rybelsus® US label was updated with additional results from the PIONEER 6 trial. On 31 January the committee for medicinal products for human use (CHMP) under the EMA adopted a positive opinion, recommending marketing authorisation for Rybelsus® (oral semaglutide) for the treat- ment of adults with type 2 diabetes. We expect to receive final marketing authorisa- tion from the European Commission in the beginning of second quarter of 2020. Biopharm Based on the ELLIPSE trial, we obtained a label expansion for Victoza® which now in- cludes an indication for the use in children and adolescent, aged 10-17 with type 2 diabetes in the US and Europe. Clinical progress The SOUL trial was initiated, a dedicated diabetes cardiovascular outcome trial, aiming to confirm the cardiovascular benefits of oral semaglutide and expand the scientific evidence base of semaglutide. The SOUL trial is expected to enrol approximately 9,600 people. Three phase 3b trials were initiated with subcutaneous (sc) once-weekly semaglu- tide: SUSTAIN FORTE, with the objective to compare and assess the efficacy and safety of sc semaglutide 2 mg compared to sc semaglutide 1 mg in people with type 2 diabetes. FOCUS, a diabetic retinopathy outcomes trial, with the objective to assess the long-term effects of sc semaglutide in people with type 2 diabetes. Lastly, FLOW, a diabetic nephropathy outcomes trial, with the objective of assessing the effect of sc semaglutide on the progression of renal impairment in people with type 2 diabetes and chronic kidney disease. Furthermore, Novo Nordisk completed a phase 2 trial with the combination of anti-IL-21 and liraglutide in people with newly diagnosed type 1 diabetes. The trial demonstrated statistically significantly im- proved beta cell function with anti-IL-21 in combination with liraglutide compared to placebo. Together with regulatory authori- ties, Novo Nordisk is evaluating next steps. Lastly, Novo Nordisk completed the 26-week phase 2 trial with insulin icodec (previously named LAI287). Insulin icodec is anticipated to be the first once-weekly insulin and have similar glucose-lowering effect and safety profile to once-daily insulin glargine U100. Based on the phase 2 results, Novo Nordisk plans to initiate a phase 3 clinical trial pro- gramme in second half of 2020. Obesity care Clinical progress We initiated a phase 2 trial for the long-act- ing amylin analogue AM833, intended for chronic weight management with a once-weekly subcutaneous administration. Regulatory events We obtained approval of Esperoct® (the brand name for N8-GP) in the US, the EU and Japan for prophylaxis and on-demand treatment of all age groups, in the EU above 12 years of age, of haemophilia A patients. In addition, the regulatory file was submit- ted for the once-weekly growth hormone derivative, somapacitan, for the treatment of adult growth hormone deficiency, to the US FDA and EMA. Clinical progress We initiated the phase 3 programme (REAL 4) for somapacitan in children with growth hormone deficiency. Furthermore, we initiated the explorer7 and explorer8 phase 3 clinical trials with subcutaneous prophylactic treatment of concizumab in people with haemophilia A or B with inhibitors and a parallel trial in haemophilia A or B patients without inhib- itors. The objective of these trials is to es- tablish the safety and efficacy of once-daily subcutaneous concizumab as a pen device based on prophylactic treatment to reduce the number of bleeds. We initiated the phase 1/2 trial for Mim8. Mim8 is a next-generation factor VIII mi- metic bi-specific antibody for subcutaneous prophylaxis of haemophilia A regardless of inhibitor status. Other serious chronic diseases Clinical progress Gilead Sciences, Inc. and Novo Nordisk established a collaboration on clinical trial activities, by combining compounds from their respective pipelines in non-alcoholic steatohepatitis (NASH). The clinical trial is a proof-of-concept study combining Novo Nordisk's semaglutide and Gilead's small molecules; the FXR agonist cilofexor and the ACC inhibitor firsocostat for the treatment of people with NASH. Results are expected in the first half of 2020. Finally, we initiated the first human dose trial (phase 1) for a subcutaneous PCSK9i. The trial is designed as a dose escalation trial with the aim to establish the safety, tolera- bility and pharmacokinetics of PCSK9i. The trial will form the basis for a review of the options for further drug development of a PCSK9i within the cardiometabolic space. • Novo Nordisk Annual Report 2019Consolidated statementsIntroducing Novo Nordisk Our business Governance 26 Social performance Novo Nordisk accounts for social performance on three dimensions: patients, employees and responsible business in pursuit of the ambition to be a sustainable business. Policies, actions and governance oversight are in place to prevent any un- wanted impacts and promote social progress through global access to healthcare, a safe, healthy and inclusive working environment with equal opportunities for all, business conduct with respect of others´ integrity and human rights, and financial contributions to communities where Novo Nordisk operates. Patients Novo Nordisk is committed to driving change to defeat diabetes and other serious chronic diseases. To fulfil this purpose, Novo Nordisk pioneers scientific breakthroughs, expand access to our medicines, and work to prevent and ultimately cure disease. In 2019, Novo Nordisk provided medical treatment to an estimated 30.0 million peo- ple with diabetes worldwide, compared with 29.2 in 2018. This 3% increase was primar- ily driven by sales of long-acting, premix and fast-acting insulins and GLP-1 products. Through Novo Nordisk’s Access to Insulin Commitment, the company guarantees to provide low-priced human insulin to gov- ernments in the poorest parts of the world and selected humanitarian organisations at a ceiling price of USD 4 per vial. As of 2019, the guarantee is expanded to include an additional 29 middle-income countries. This means that a total of 78 countries, as well as selected humanitarian organisa- tions, can benefit from this guarantee. An estimated 2.9 million people were treated with insulin under this commitment in 2019, of which approximately 200,000 people were reached through sales to humanitarian organisations. In 2019, the average price the insulin was sold at equals USD 0.12 per patient per day. Beyond this commitment, Novo Nordisk sold human insulin at or below the ceiling price in other countries, reaching an estimated additional 2.2 million people in 2019. Novo Nordisk has several initiatives, programmes and partnerships focused on increasing access to care all over the world. See novonordisk.com. Novo Nordisk takes a patient-centred ap- proach in its care delivery model and learns with patients. For additional information, see the 'Our Business section' and novonordisk.com. Employees Novo Nordisk aims to be an attractive employer that offers a safe and healthy, inclusive and engaging working environ- ment in which all employees have equal opportunities to realise their potential. At the end of 2019, the total number of employees was 43,258, corresponding to 42,703 full-time positions, which is a less than 1% increase compared with 2018. The underlying growth in employees was mainly driven by Region China. Employee turnover decreased from 11.7% in 2018 to 11.4%. Novo Nordisk’s responsibility to respect la- bour rights applies to our global operations as a global minimum standard of business conduct. In 2019, the Global Labour Code of Conduct was revitalised and reinforced to ensure alignment with Novo Nordisk’s Business Ethics Compliance Framework, which includes respect of human rights. The Code of Conduct describes expected global minimum labour rights requirements for Novo Nordisk employees including the principles concerning fundamental rights in the eight ILO Core Conventions and labour rights as stipulated in the International Bill of Human Rights. Minimum paid maternity leave is increased from 12 to 14 weeks globally and a right to paid paternity leave is introduced. Moreover, guidance to avoid forced and bonded labour/child labour and young workers is better described, the right to social security is affirmed, and life insurance for all employees is introduced. For more information see novonordisk.com. In addition, Novo Nordisk entered a 5-year living wage programme with an external global non-profit business network and consultancy. The objective is to ensure that all employees are paid a living wage, i.e. adequate to purchase basic goods and ser- vices necessary to achieve a basic standard of living, based on calculations of living wages in the countries we operate in. An analysis indicated that this is the case. By the end of 2019, the gender distribution among managers was 60% men and 40% women, unchanged from 2018. Through 2019 diversity and inclusion have been strategic and tactical priorities for Novo Nordisk. The launch of the Diversity Aspiration of achieving gender balance at all managerial levels and the Diversity Ac- tion Plan with new guidelines and flexible working conditions have created direction towards becoming a more inclusive compa- ny. Novo Nordisk acknowledges the impor- tance of leadership role modelling inclusive behaviour to lead a sustainable work place where everyone is able to perform at their best. The strong stance on diversity and inclusion will continue in 2020 with focus on realising continuous impact from the initiatives. Novo Nordisk is committed to ensuring fair and equal treatment, opportunities – and pay – for all employees regardless of gender. In 2019, we conducted a study on gender and equal pay covering more than 50 countries and over 25,000 employees in order to reveal any differences in pay level or annual bonus due to gender. In a few locations, we identified some differences that need to be further investigated, and if due to gender, corrected. The equal pay study will be repeated in 2020 to ensure a continued focus. The average frequency rate of occupational accidents with absence was 2.2 per million working hours in 2019 compared with 2.4 in 2018. In 2019, Novo Nordisk had one work-related fatality compared with none in 2018. Novo Nordisk works with a zero-injury mindset and remains com- mitted to continuously improving safety performance. Employees are encouraged to always make the safe choice, and it is emphasised that safety behaviour is part of the company values. Novo Nordisk Annual Report 2019Consolidated statementsIntroducing Novo Nordisk Our business 27 Responsible business Measures are taken to ensure that Novo Nordisk conducts its business in a respon- sible way, in accordance with the Novo Nordisk Way. Business ethics, data privacy and human rights In Novo Nordisk Business Ethics, Data Priva- cy and Human Rights is about acting with integrity and in compliance with the Novo Nordisk Way, the Business Ethics Code of Conduct as well as international and local standards for responsible business conduct. Training in Business Ethics is mandatory and a high priority. Annual Business Ethics training is required for all employees, includ- ing new hires. Business Ethics training is therefore a key element of the onboarding programmes. In 2019, 99% of all relevant employees completed and documented their training. This high level is attributed to the constant focus on and communication by senior management of the importance of business ethics compliance. In 2019, 34 business ethics reviews were completed with 87 findings, compared with 33 re- views with 113 findings in 2018. Based on the completed business ethics reviews, it is Group Internal Audit's assessment that the business ethics compliance level is sound. Management action plans and closure of findings progressed as planned, and there were no overdue Management actions or findings at the end of the year. During 2019 Novo Nordisk developed and approved its internal corporate require- ments on Data Privacy and Human Rights which is operationalised in the Novo Nordisk’s Business Ethics Code of Conduct. The requirements set out guidance and expectations to all employees. Furthermore, Data Privacy and Human Rights risks (‘risks to people’) were integrated into the Busi- ness Ethics risk methodology, as the basis for risk management in the Novo Nordisk global organisation as of 2020. Progress was made in regard to manage- ment of salient human rights issues beyond those already addressed by existing global standards and programmes. In 2019, for patient safety and the right to health, we further increased the share of Novo Nordisk subsidiaries providing access to safety reporting with local language directions on local websites, from 90% in 2018 to 96% in 2019. For availability and affordability aspects of the right to health, see progress above. To mitigate risks of exploitation and ensure respect for donors’ right to free and informed consent among others, we evaluated and delisted human biosample providers and reduced the ratio of the unevaluated providers we use, from 12% in 2018 to 6% in 2019. We have also developed a risk-based global due diligence system. The Responsible Sourcing standards were updated in December 2019 to strengthen its human rights coverage. For our due diligence on modern slavery risks, see Novo Nordisk’s Modern Slavery Statement at novonordisk.com. In 2019, a total of 236 supplier audits, un- dertaken by Novo Nordisk's own organisa- tion, were conducted to assess compliance levels with the company's standards for suppliers. Of these, 27 were responsible sourcing audits and one critical finding was issued regarding working hours. An action plan with deadlines has been agreed upon and a re-audit is planned for 2020. To create certainty regarding tax payments, Novo Nordisk has applied for advance pricing agreements (APAs) in key countries. The ambition is to have APAs covering more than two-thirds of total sales. An APA is an up-front agreement between the tax authorities in two or more countries, covering the pricing methodologies for rel- evant intercompany transactions, thereby determining the level of taxable income for the countries in question. An APA typically covers a future period of five tax years. Novo Nordisk has APAs in place covering intercompany transactions with the US, Canada, Japan, India and China corre- sponding to more than 60% of total sales. Novo Nordisk's tax strategy is endorsed by the Board of Directors. Long-term social targets Novo Nordisk has two long-term social targets related to employee engagement and trust. Product quality Novo Nordisk had four product recalls from the market in 2019, compared with three in 2018. As in 2018, none of the recalls were critical. Local health authorities were informed in all instances to ensure that dis- tributors, pharmacies, doctors and patients received appropriate information. The level of employee engagement and commitment to the company’s values re- mains high. In the annual employee survey, conducted in the second quarter of 2019, 91% of employees responded positively to a set of questions to measure the level of engagement, same as in 2018. The target is at least 90%. In 2019, as in 2018, there were no failed inspections by regulatory authorities among those resolved at year-end. In 2019, 66 inspections were conducted at Novo Nordisk’s sites, at clinics conducting investigations for Novo Nordisk or for voluntary ISO 9001 certification, compared with 75 inspections in 2018. At year-end, 44 inspections had been passed and 22 were unresolved. Follow up on unresolved inspection continues in 2020. Responsible tax approach Novo Nordisk’s tax approach is to pursue a competitive tax level in a responsible way. As a general rule, Novo Nordisk subsidiaries pay corporate taxes in the countries in which they operate and where business activity generates profits, earned in accordance with international transfer pricing rules. A competitive tax level implies achieving a tax level around the peer-group average. The company has a balanced tax risk profile and does not engage in tax avoidance activities. See 'Note 2.6 income taxes and deferred income taxes' and 'Note 9.8 total tax contribution'. The level of trust in Novo Nordisk among key stakeholders - people with diabetes, general practitioners and diabetes special- ists - is an indicator of the extent to which the company lives up to stakeholders' ex- pectations and the likelihood that they will trust, support and engage with the com- pany. The company trust score, measured on a scale of 0-100, decreased to 78.2 from 84.5 in 2018. The decline in trust can best be explained by the increased scrutiny on pharma industry throughout 2019, in particular in regards to pricing, access and affordability of medicines, which continues to be reflected in media sentiment and social media conversations. The decline in trust is not unique to Novo Nordisk, but is a trend across the pharma sector. Data were collected between June and September 2019; a score between 70 and 80 is con- sidered strong. The target is at least 80. Read more details in the 'Consolidated social statement' and novonordisk.com. • Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo Nordisk Our business 28 Environmental performance Waste Compared to 2018, waste decreased by 13% in 2019. This was due to a decreased amount of both ethanol waste and organic residues from the production of API in Kalundborg. Novo Nordisk has a bold and simple ambition: to have zero environmental impact. To get there we are adopting a circular mindset – designing products that can be recycled or re-used, reshaping our business practice to minimise consumption and eliminate waste, and working with suppliers who share our ambition. Our bold ambition is communicated through the new Circular for Zero environmental strate- gy. We measure our progress based on use of resources, emissions and waste. Resources In 2019, the energy consumption for op- erations decreased slightly compared with 2018. There is a continued focus on ener- gy-saving projects within production, and projects implemented in 2019 are expected to result in annual savings of 72,000 GJ. Water consumption in production sites in 2019 increased slightly by 2% compared with 2018. Three facilities in Algeria, Brazil and China are in areas with water stress or high seasonal variability. These sites accounted for 14% of the total water con- sumption in 2019, and there is a continued focus on reducing water consumption across these sites. As part of the new Circular for Zero strategy, procurement is collaborating with suppliers to reduce environmental impact across the value chain via a gradual shift to sustainably sourced materials. Novo Nordisk is also working to ensure ex- isting and new products are fit for circulari- ty, and, in 2019, a Circular Design Guideline was developed within R&D to reduce the environmental footprint of our devices. Emissions In 2019, total emissions across operations and transportation were 306,000 tons CO2, which is a 10% increase compared to 2018, primarily due to a significant increase in emissions from product distribution. This was due to an increase in distributed volume, and the fact that there was more air freight than sea freight due to supply and market-driven challenges. In 2020, Novo Nordisk has focus on ensuring a shift to sea freight and to en- sure efficient production planning to reduce emissions from product distribution. Emissions from production remained stable compared to 2018. At the end of 2019, the conversion of Asnæs power plant in Kalund- borg, Denmark was completed in collab- oration with the energy company, Ørsted. This means that future heat and steam for our largest production site will come from sustainable biomass instead of fossil fuels. Overall, 93% of waste generated from production is recycled, used for biogas production or incinerated in waste-to-ener- gy plants. In 2019, 1% of total waste was sent to landfill. One strategic focus of the Circular for Zero strategy is to investigate the end-of-life challenge of devices following patient use, for the materials can be recovered and recycled into new products. With the use of bionatural gas and steam based on biomass in Denmark, as well as power from renewable sources across global production sites, it is expected that more than 75% of the total energy use for production sites will be based on renew- able sources in 2020. Emissions from global offices and labs decreased by 15,000 tons CO2 in 2019. As a part of the new Circular for Zero strategy, all offices and labs will source renewable power by 2030. In 2019, there was a significant re- duction in CO2 emissions from the R&D site in Beijing, due to sourcing of wind power. Emissions from company cars remained stable at 62,000 tons CO2 in 2019. In order to decrease emissions from company cars and encourage the global shift to electric vehicles, Novo Nordisk joined EV100 this year. This partnership means that Novo Nordisk commits to transitioning the entire fleet of approximately 8,000 vehicles to hybrid and electric vehicles by 2030. Emissions from business flights are estimat- ed to be 65,000 tons CO2 in 2019, a small increase compared to 2018. In 2019, Novo Nordisk invested in 55 new, larger video conferencing systems and five immersive video systems to enhance the conferencing experience. In 2019, over 90 major events were hosted from Livestream, including updates from Executive Management. An ambitious circular supplier program, 'Suppliers for Zero', was initiated as part of the Circular for Zero strategy. Twelve key suppliers have enrolled in 2019 of which four have committed to achieving zero CO2 emissions. Long-term environmental targets In 2019, 76% of power for production sites was sourced from renewable energy. In 2019, Novo Nordisk finalised an agreement in the United States to have solar energy cover power consumption across all US op- erations. This agreement is effective as of 2020. With this solution, Novo Nordisk will achieve its target to source 100% renew- able power at all production sites in 2020. In 2019, total emissions across operations and transportation was 306,000 tons CO2. Emissions are expected to decrease signifi- cantly in 2020 due to various renewable energy projects, including solar power across all US operations, wind power in Europe and green steam in Denmark. Emis- sions from transportation are also expected to decrease due to a company car policy that encourages transition to hybrid and electric vehicles and through collaboration with EV100, (The Climate Group's global initiative for electrical vehicles). The target is to have zero emissions from operations and transportation by 2030 and it covers production sites, over 80 offices and labo- ratories, company cars, business flights and product distribution and was approved by the Science Based Target Initiative. Read more details in the 'Consolidated environmental statement' and novonordisk. com. For a full breakdown of climate and water impacts please refer to the publicly available Novo Nordisk CDP disclosures. Details about Circular for Zero, including R&D developments and procurement can be found on novonordisk.com. • Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo Nordisk Our business Governance 29 Managing risks to protect value For Novo Nordisk to continue to be a sustainable business, we must anticipate and adapt to changes in our markets to create new stra- tegic opportunities. Managing the associated risks rigorously and systematically is key in order for us to create and protect value over the short, medium and long term. Scenario and risk-thinking exercises are part of our strategic planning process. They include analyses of market dynamics as well as socioeconomic and political de- velopments that present risks or opportuni- ties for our business. Balancing affordable care and commercial value In the short and medium term, we zoom in on trends in the healthcare ecosystem we rely on. For example, in the diabetes care market, payers continue to put pressure on costs of insulin and are unwilling to pay a premium for incremental innovation. For our business, the risks are reduced profit from lower prices, and the damage to brand trust could be significant if we were seen to be profiteering from the situation. The US healthcare system’s structural chal- lenges continue to be a risk to our business as well. Affordable access to essential medi- cines is a big issue for the approximately five percent of Americans who are uninsured. This will be front and centre in the 2020 elections. Meanwhile, US market dynamics are forging new healthcare alliances that affect negotiations between payers and providers of medicines. Access to afford- able care is not just an US issue. Globally, healthcare systems are struggling to provide quality care at a sustainable cost, while the burden of chronic disease keeps rising. Digital disruption New digital technologies in healthcare are offering more personalised treatment and better management of chronic diseases. This is an opportunity to deliver more value to our stakeholders and help patients live a life free from the limitations of their disease. But the rise of digital healthcare brings risks of its own. New entrants and disrup- tive competitors, including large tech play- ers as well as new start-ups, will be able to leverage big data analytics to address some of the inefficiencies in the current healthcare systems. This will affect some of our markets, and we will have to act to avoid losing market share. Artificial Intelligence (AI) and automation in the sector should make us more productive and speed up our time-to-market. Today, we are running several AI and automation pilots to accelerate innovation and harvest efficiency gains. Highly agile technolo- gy sector companies could enter with disruptive approaches to health care. AI is associated with issues such as unpredict- ability of future uses. Moreover, new collaborations with per- sonal healthcare players bring new risks – particularly around increased complexity, shared commercial arrangements and data regulation. The personal healthcare apps need to be tested for quality and reliabil- ity. If they do not work properly and give the correct guidance, they could present a health risk to the patients using our products. Facing up to environmental risks Across all of these trends runs a growing and widely acknowledged concern for the global environment, particularly in relation to climate change. We are preparing for the risks and oppor- tunities which will arise from changing weather patterns, sea level rises and other climate impacts. As recommended by the Task Force on Climate-related Financial Disclosures, we are integrating climate change scenarios to identify short, medium and long-term risks within our production and supply chain to ensure a steady supply of medicine to patients. Rigorous and robust risk management A rigorous approach to enterprise risk man- agement helps our management protect and enhance the value of our tangible and intangible assets. We are continually exposed to risks throughout our value chain – from early discovery of new, promising molecules to the production and delivery of medicines to patients. Some risks are inherent in the pharmaceutical industry, such as delays or failures of potential new medicines in the R&D pipeline. Other risks such as supply disruptions and competitive threats are well-known to any manufacturing com- pany with global production. We will never compromise on product quality, patient safety and business ethics: these are front and centre of our enter- prise-wide risk management set-up. We apply a two-way lens and assess risks to people as well as potential financial loss and reputational damage. Executive Management and the Board of Directors review a ‘heat map’ of our biggest risks biannually. This map is based on insights from management teams in all organisational areas and includes risks that could cause significant disruptions to the business over a three-year horizon. There is a more detailed overview of our key risks in the following overview. Novo Nordisk Annual Report 2019Consolidated statementsIntroducing Novo Nordisk Our business Governance Consolidated statements 30 Novo Nordisk's key risks What is the risk? What is the impact? What actions are taken? Delays or failure of products in pipeline The development of a product candidate can take more than 10 years and may be delayed, or even abandoned, at substantial expense. The process involves non-clinical tests and clinical trials, commercial product planning and regulatory approval, including approval of production facilities. Patients would not benefit from innovative treatments and Novo Nordisk’s future posi- tion as a leader could be jeopardised if we were unable to bring innovative products to market. Any delays or failures of new products could have an adverse impact on sales, profits and market position. Insights into patients’ unmet needs inform the selection of new product candidates. Clinical trials are run to demonstrate safety and efficacy. Assessments of commercial viability determine progress through stage gates. Consultations are held with regula- tors to review clinical findings and obtain guidance on clinical programmes. Supply disruptions Failures or delays may occur at production sites or throughout the extensive global supply chain, relating to procurement of ingredients and components as well as distribution of products. This could be due to breakdowns or quality failures at com- pany sites or at key suppliers’ production facilities. If Novo Nordisk were prevented from supplying products to markets, pharmacies and hospitals could face product shortages, with potential implications for patients’ daily treatment needs. Competition and market developments Governments and private payers take measures to limit spending on medicines by driving down prices, demanding higher rebates and restricting access to and reimbursement of new products. In some markets, political instability, conflict or weak enforcement of the rule of law may affect sales. At any time, established or new competitors may bring new products to market or obtain label change for marketed products, leading to increased competition. Patients would not have access to the clinical benefits of new products if Novo Nordisk were prevented from launching new products due to reimbursement restrictions and newer products could be niched for use in narrow sub-populations. Across all markets, product categories could face intensified competition and in these categories lower realised prices would be expected. Compromises to product quality and patient safety Product quality and patient safety may be compromised if, for example, a production facility is found to be in noncompliance, a product is not within specifications, or if side effects that were not detected in clini- cal trials become apparent when a product is used for a longer period of time. Patients’ health and lives could be put at risk and Novo Nordisk’s reputation and licence to operate could be damaged if regulatory compliance is not ensured. Internal quality audits and annual inspec- tions by regulatory authorities document GMP compliance, and alternative supply sites for critical raw materials and back-up facilities are in place for key production plants and safety inventories, to pre- vent and respond to accidents or other disruptions to supplies. Global production reduces supply risks. Clinical trial data demonstrate the added value of new products. Real-world evidence is introduced to show health economic benefits. Negotiations with payers aim to ensure patients’ access to the clinical bene- fits of new products. A robust quality management system, improvement plans and systematic senior management reviews are in place. Author- ity inspections and internal quality audits are conducted at production sites. When issues are found within the production pro- cess of clinical or marketed products, root causes are identified and corrected and, if necessary, products are recalled. Novo Nordisk Annual Report 2019Introducing Novo Nordisk Our business Governance Consolidated statements 31 What is the risk? What is the impact? What actions are taken? IT security breaches Disruption to IT systems, such as virus attacks, and breaches of data security, may happen across the global value chain, where reliable IT systems and infrastruc- ture are critical for the company’s ability to operate effectively. Patients’ or other individuals’ privacy could be compromised if confidential information were disclosed, and breaches of IT security could have a severe impact on Novo Nor- disk’s ability to maintain operations and hence on its financial situation. In produc- tion environments, for example, breaches of IT security could impact Novo Nordisk’s ability to produce and safeguard product quality. IT security technologies and controls are in place to help prevent intruders from causing damage to systems and gaining access to critical data and systems. Con- tinuity plans are in place in the event of non-availability of IT systems. Awareness campaigns, access controls and intrusion detection and prevention systems have been implemented. Company-wide internal audits of IT security controls are conducted to detect and mitigate any breaches. Currency impact and tax disputes Exchange rate fluctuations, disputes with tax authorities and changes to tax legislation are external factors. Novo Nordisk’s foreign exchange risk is most significant in USD, CNY and JPY, while the EUR exchange rate risk is regarded as low due to Denmark’s fixed-rate policy towards EUR. Novo Nordisk’s cash flow, statement of comprehensive income and balance sheet can be impacted significantly by currency fluctuations. Changes to tax legislation or loss of major tax cases could result in signif- icant tax adjustments and fines, and could lead to a higher-than-expected tax level for the company. Breach of legislation or ethical standards In a tightly regulated industry, breach of legislation, industry codes or company policies may occur in connection with business interactions, such as with health- care professionals, business partners or other stakeholders. Operations in complex socioeconomic and cultural contexts could present risks of non-compliance with Business Ethics standards including human rights and personal data protection. Breaches of legislation or ethical standards could compromise the integrity, dignity and rights of the individuals involved and could cause damage to Novo Nordisk’s reputation and financial situation and could expose Novo Nordisk to investigations, criminal and civil sanctions and other penalties. Loss of intellectual property rights The validity of patents that are critical for protecting Novo Nordisk’s commercial products and candidates in the R&D pipe- line may be challenged by competitors. Loss of exclusivity for existing and pipeline products could impact Novo Nordisk’s market position, sales and profits. Expected future cash flows for selected currencies are hedged to mitigate short- term impact on earnings and cash flow. An integrated treasury management system is in place. Applicable taxes are paid in jurisdictions where business activity gen- erates profits. Multi-year advance pricing agreements with tax authorities have been negotiated for more than 60% of our sales in the US, China and Japan. Hedging activ- ities and calculation of transfer pricing are subject to internal controls and audit. Compliance programmes address ad- herence, such as the Business Ethics Compliance Framework, supported by due diligence, standard procedures and training to ensure compliance with laws, international standards and regulations and prevent breaches of standards, with legal defence where relevant. Compliance with business ethics standards is subject to internal audit. Action is taken immediately on substantiated non-compliance. Throughout the process of drafting, filing and prosecuting a patent application, internal controls are in place to minimise vulnerability to invalidity actions. Patents at high risk of invalidity challenge are proac- tively identified to defend Novo Nordisk’s intellectual property rights. Novo Nordisk Annual Report 2019Introducing Novo Nordisk Our business Governance 32 Shares and capital structure Through open and proactive communication, the company aims to provide the basis for fair and efficient pricing of its shares. However, in practice, A shares and B shares receive the same amount of dividend per share. As of 31 December 2019, Novo Holdings A/S also held a B share capital of nominally DKK 27,152,800. Novo Holding A/S's total ownership is reflected in the following chart of ownership structure. There is no complete record of all share- holders; however, based on available sources of information about the company’s shareholders, as of 31 December 2019 it is estimated that shares were geographically distributed as shown in the chart 'Geo- graphical split'. As of 31 December 2019, Ownership structure Novo Nordisk Foundation Novo Holdings A/S 76.1% of votes 28.1% of capital A shares 537 million shares Share capital and ownership Novo Nordisk’s total share capital of DKK 480,000,000 is divided into an A share capital of nominally DKK 107,487,200 and a B share capital of nominally DKK 372,512,800. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen and on the New York Stock Exchange (NYSE) as American Depository Receipts (ADRs). Novo Nordisk’s A and B shares are calculated in units of DKK 0.20, resulting in 537 million A shares and 1,863 million B shares. Each A share carries 200 votes and each B share carries 20 votes. The company’s A shares are not listed and are held by Novo Holdings A/S, a Danish public limited liability company wholly owned by the Novo Nordisk Foundation. The Foundation has a dual objective: to provide a stable basis for the commercial and research activities conducted by the companies within the Novo Group (of which Novo Nordisk A/S is the largest), and to support scientific and humanitarian purposes. According to the Articles of Association of the Foundation, the A shares cannot be divested. Special rights attached to A shares include pre-emptive subscrip- tion rights in the event of an increase in the A share capital and pre-emptive purchase rights in the event of a sale of A shares, while B shares take priority for liquidation proceedings. A shares take priority for dividends below 0.5%, and B shares take priority for dividends between 0.5 and 5%. the free float of listed B shares was 90.1% (of which approximately 11.9% are listed as ADRs), excluding the Novo Holdings A/S holding and Novo Nordisk’s holding of treasury shares which, as of 31 December 2019, was DKK 36,780,840 nominally. For details about the share capital, see note 4.1. Capital structure and dividend policy Novo Nordisk’s Board of Directors and Executive Management consider that the current capital and share structure of Novo Nordisk serves the interests of the share- holders and the company well, providing the strategic flexibility to pursue Novo Nordisk’s vision. Novo Nordisk’s capital structure strategy offers a good balance between long-term shareholder value cre- ation and competitive shareholder return in the short term. Novo Nordisk’s guiding principle is that, after the funding of organic growth opportunities, investments and acquisitions, any excess capital should be returned to investors. The company’s dividend policy applies a pharmaceutical in- dustry benchmark to ensure a competitive payout ratio for dividend payments, which are complemented by share repurchase programmes. The final dividend for 2018 paid in March 2019 was equal to DKK 5.15 per A and B share of DKK 0.20 as well as for ADRs. The total dividend for 2018 was thus DKK 8.15 per A and B share of DKK 0.20, corresponding to a payout ratio of 50.6%, which is in line with the 2018 pharma peer group average of 49.4%. In August 2019, an interim dividend was paid equalling DKK 3.00 per A and B share of DKK 0.20 as well as for ADRs. For 2019, the Board of Directors will propose a Institutional and private investors 23.9% of votes 71.9% of capital B shares 1,863 million shares Novo Nordisk A/S Note: Treasury shares are included, however, voting rights of treasury shares cannot be exercised Novo Nordisk Annual Report 2019Consolidated statementsIntroducing Novo Nordisk Governance 33 final dividend of DKK 5.35 to be paid in March 2020, equivalent to a total dividend for 2019 of DKK 8.35 and a payout ratio of 50.5%. The company expects to distribute an interim dividend in August 2020, and further information regarding such interim dividend will be announced in connection with the financial report for the first six months of 2020. Dividends are paid from distributable reserves. Share premium is a distributable reserve and any former share premium reserve has been fully distributed. Novo Nordisk does not pay a dividend on its holding of treasury shares. Share repurchase programme for 2019/2020 During the twelve-month period beginning 1 February 2019, Novo Nordisk repur- chased shares worth DKK 15 billion. The share repurchase programme has primarily been conducted in accordance with the safe harbour rules in the EU Market Abuse Regulation (MAR). For the next 12 months, Novo Nordisk has decided to implement a new share repurchase programme. The expected total repurchase value of B shares amounts to a cash value of up to DKK 17 billion. The total programme may be reduced in size if significant product in- licensing or bolt-on acquisition oppor- tunities arise during 2020. Novo Nordisk expects to conduct the majority of the new share repurchase programme according to the safe harbour rules in MAR. At the Annual General Meeting in March 2020, the Board of Directors will propose a further reduction in the company’s B share capital, corresponding to approximately 2% of the total share capital, by cancel- ling 50,000,000 treasury shares. After the implementation of the share capital reduction, Novo Nordisk’s share capital will amount to DKK 470,000,000 divided into A share capital of DKK 107,487,200 and B share capital of DKK 362,512,800. Share price development Novo Nordisk’s share price increased by 29.8% between its 2018 close of DKK 297.9 and the 31 December 2019 close of DKK 386.65. For comparison purposes, the Danish OMXC25 stock index increased by 26% and the pharma peer group increased by 13% during 2019. The total market value of Novo Nordisk’s A and B shares, excluding treasury shares, was DKK 909,178,012,657 as of 31 December 2019. • Geographial split* % of share capital 2019 2018 % 50 40 30 20 10 0 Denmark North America UK and Ireland Other *Using shareholder registered home countries Cash distribution to shareholders Dividend for prior year Interim dividend Share repurchases in the calendar year Free cash flow DKK billion 40 30 20 10 0 2016 2017 2018 2019 2020E Share price performance 2019 Novo Nordisk share price and indexed peers1 Novo Nordisk Pharmaceutical industry index* OMXC25 DKK 400 360 320 280 240 200 Jan Feb Mar Apr May June July Aug Sep Oct Nov Dec *Pharmaceuticals index comprises: AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Pfizer, Roche, Sanofi and Novo Nordisk 1. OMX C25 and pharmaceutical industry development have been rebased to Novo Nordisk share price in January 2019 Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo Nordisk Governance 34 Corporate governance The Board of Directors of Novo Nordisk focuses on good gover- nance practices. In 2019, one new board member was appointed at the Annual General Meeting. Two members of Executive Manage- ment left Novo Nordisk after more than 20 years with the company and two new members of Executive Management were appointed. Governance structure Shareholders The shareholders of Novo Nordisk have ultimate authority over the company and exercise their right to make decisions at general meetings. At the Annual Gen- eral Meeting, shareholders approve the annual report and any amendments to the company’s Articles of Association. Shareholders also elect board members and the independent auditor. Resolutions can generally be passed by a simple majority. However, resolutions to amend the Articles of Association require two-thirds of the votes cast and capital represented, unless other adoption requirements are imposed by the Danish Companies Act. Novo Holdings A/S holds the majority of votes at general meetings. However, all strategic and operational matters are decided solely by the Board of Directors and Executive Management. Read more about the ownership structure of Novo Nordisk in 'Shares and capital structure'. Board of Directors Novo Nordisk has a two-tier management structure consisting of the Board of Direc- tors and Executive Management. The two bodies are separate, and no one serves as a member of both. The Board of Directors supervises Executive Management, determines the company’s overall strategy and follows up on its Corporate governance codes and practices implementation, the performance, ensures adequate management and organisation and, as such, actively contributes to devel- oping the company as a focused, sustain- able, global pharmaceutical company. The Board of Directors may also distribute extraordinary dividends, issue new shares or repurchase shares in accordance with authorisations granted by the sharehold- ers at the Annual General Meeting and recorded in the meeting minutes available at novonordisk.com/about_us. Shareholder-elected board members serve for a one-year term and may be re-elected. Board members must retire at the first An- nual General Meeting after reaching the age of 70. One board member is a member of the Board of Directors of Novo Holdings A/S, and one board member is chief executive officer of Novo Holdings A/S and may be regarded as representing the interests of the controlling shareholder, while seven of the nine shareholder-elected board members are independent as defined by the Danish Corporate Governance Recommendations. Under Danish law, employees in Denmark may elect a number of board members equalling half of the shareholder-elected board members. Board members elected by employees serve for a statutory four-year term and have the same rights, duties and responsibilities as shareholder-elected board members. The employee-elected board members are up for election again in 2022. Read more about the members of the Board of Directors and at novonordisk. com/about_us. Compliance Governance structure Assurance Danish and foreign laws and regulations Corporate governance standards Shareholders Board of Directors Chairmanship* Audit Committee Nomination Committee Remuneration Committee R&D Committee Executive Management Novo Nordisk Way Organisation * The Chairmanship is directly elected by the Annual General Meeting. Audit of financial data and review of social and environmental data (internal and external) Facilitation (internal) Quality audit and inspections (internal and external) Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo Nordisk Governance 35 As of 31 December 2019, the Board of Directors consisted of 13 members, nine of whom were elected by shareholders and four of whom were elected by employees based in Denmark. The Board of Directors met eight times during 2019. At the Annual General Meeting in March 2019, Laurence Debroux was elected as new member of the Board of Directors. utive succession, board composition and succession, potential over-boarding and training as well as the performance of the Chairmanship and the board committees. In addition, each member of the Board of Directors and Executive Management is provided with feedback from all other board members and executives on their individual performance. Nomination, self-evaluation and diversity A proposal for election or re-election of shareholder-elected board members is presented by the Nomination Committee to the Board of Directors. When recom- mending candidates to be nominated by the Board, the Nomination Committee considers factors such as the balance between renewal and continuity, the desired competences and experience, the performance of the individual Board mem- bers, the ambition for diversity as well as independence considerations. To support continued fulfilment of the Novo Nordisk Way, in the Board com- petence profile the Board of Directors has determined that the Board members should possess integrity, accountability, fairness, financial literacy, commitment and desire for innovation. Additionally, the following competences and experience should be represented on the Board: global business management, strategic operations and governance, healthcare industry and market access, research and development, technology and digitalisation, M&A and external innovation sourcing, people lead- ership and change management as well as finance and accounting, cf. the biographies of Board members in the overview 'Board of Directors'. The competence profile, which includes the nomination criteria, is available at novonordisk.com/about_us. The Board of Directors conducts a self-eval- uation every year. The self-evaluation includes all members of the Board and Ex- ecutive Management. The chair has overall responsibility for conducting the self-eval- uation. The self-evaluation is facilitated every third year by external consultants, who interview all members of the Board of Directors and Executive Management. For the subsequent two years, the self-evalu- ation is facilitated by the secretary of the Nomination Committee based on written questionnaires. The process evaluates topics such as board dynamics, board agenda and discussions, strategy, culture, exec- In 2019, the Board evaluation was facili- tated internally and, in general, revealed good performance by the Board and good collaboration between the Board and Executive Management. The process also resulted in continued focus on the implementation of the R&D strategy, on commercial execution and on being a sustainable company. To ensure that discussions include multiple perspectives representing the complex, global pharmaceutical environment, the Board of Directors aspires to be diverse in gender and nationality. In 2016, the Board of Directors adjusted its diversity ambition and set new targets with the aim of consisting, by 2020, of at least two shareholder-elected board members with Nordic nationality and at least two shareholder-elected board members with a nationality other than Nordic – and at least three shareholder-elected board members of each gender. As of 31 December 2019, three shareholder- elected board members were female and six were male, while seven of the nine shareholder-elected board members were non-Nordic and two were Nordic. The company thus fulfilled its nationality ambition and its gender ambi- tion. The Board of Directors will revisit its diversity ambition in 2020 and, if needed, adjust the numbers and parameters which are currently fulfilled. In accordance with section 99b of the Danish Financial Statements Act, Novo Nordisk discloses current performance on diversity in the 'Social performance' section. Novo Nordisk’s diversity policy is available at novonordisk.com. Board committees Chairmanship The Chairmanship consists of the chair and the vice chair, both of whom are elected directly by the shareholders at the general meetings. At the Annual General Meeting in 2019, Helge Lund was re-elected as chair and Jeppe Christiansen was re-elected as vice chair. The Chairmanship assists the Board of Directors in the planning of Board meetings, employment of Executive Man- agement and other assignments as decided by the Board. In 2019, the Chairmanship particularly discussed commercial execution within the therapy areas and in different mar- kets, partnering and acquisition to access external innovation as well as talent and leadership development, supervising the changes in Executive Management and development of the company culture. Audit Committee The Audit Committee assists the Board of Directors with oversight of the exter- nal auditors, the internal audit function, handling hotline complaints, financial, social and environmental reporting, business ethics compliance, information security, insurance coverage, special theme reviews and other tasks on an ad hoc basis, as specifically decided by the Board. All members have relevant industry expertise. For independence see table on meeting participation in 2019. The Audit Committee is appointed by the Board and consists of: • Liz Hewitt (chair; financial expert) • Laurence Debroux (financial expert) • Andreas Fibig • Sylvie Grégoire • Stig Strøbæk In 2019, the Audit Committee focused particularly on reviewing and discussing work performed by internal and external auditors and held focused sessions on risks and internal controls in key areas such as North America Operations, Product Supply and International Operations. The Audit Committee also discussed key accounting policies and estimates, including provi- sions for sales rebates, indirect production costs and ongoing tax and legal cases. The Audit Committee also reviewed and discussed the status of Information Security and Business Ethics Compliance within Novo Nordisk. Finally, the Audit Committee recommended a preferred external auditor which is to be selected by the Annual Gen- eral Meeting in 2021. Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo Nordisk Governance 36 Nomination Committee The Nomination Committee assists the Board with oversight of the competence profile and composition of the Board, nom- ination of members and committees, the corporate governance of the company and other tasks on an ad hoc basis, as specifi- cally decided by the Board. The Nomination Committee is appointed by the Board and consists of: • Helge Lund (chair) • Sylvie Grégoire • Kasim Kutay • Mette Bøjer Jensen In 2019, the Nomination Committee focused particularly on reviewing the com- position of the Board and considered long- term succession planning. It also reviewed the desired competences to be represented on the Board. Remuneration Committee The Remuneration Committee assists the Board with oversight of the remuneration policy as well as the actual remuneration of board members, Board committees and Executive Management. The Remuneration Committee is appointed by the Board and consists of: • Jeppe Christiansen (chair) • Brian Daniels • Liz Hewitt • Anne Marie Kverneland In 2019, the Remuneration Committee fo- cused particularly on conducting a general review of executive remuneration, includ- ing proposing changes to the base salary, the pension, the short-term cash-based incentive programme, the long-term share- based incentive programme, the sharehold- ing requirement, etc., and on developing of a new Remuneration Policy to be approved by the Annual General Meeting and a new separate Remuneration Report to be pre- sented to the Annual General Meeting. Research & Development Committee The Research & Development Committee assists the Board with oversight of the research and development strategy, the pipeline, the R&D organisation and other tasks on an ad hoc basis, as specifically decided by the Board. The Research & Development Committee is appointed by the Board and consists of: • Martin Mackay (chair) • Brian Daniels • Sylvie Grégoire • Thomas Rantzau In 2019, the Research & Development Committee focused particularly on reviewing the results of clinical trials and discussed potential additional research and development activities to further explore opportunities within subcutaneous and oral GLP-1 as well as competitor initiatives. In addition, the committee discussed the po- tential opportunities for addressing unmet needs in NASH. It also reviewed potential external research collaborations as well as acquisitions. See the Corporate Governance Report or novonordisk.com/about_us for a more de- tailed description of the Board committees, their charters, details on members and full reports on the Board committees’ activities in 2019. Executive Management Executive Management is responsible for overall day-to-day management, the organisation of the company, allocation of resources, determination and implemen- tation of strategies and policies, direction setting, and ensuring timely reporting and provision of information to the Board of Directors and Novo Nordisk’s stakeholders. Executive Management meets at least once a month. The Board of Directors appoints members of Executive Management and determines their remuneration. The Chair- manship reviews the performance of the executives. To ensure the organisational implementa- tion of the strategy, Executive Management has established a Management Board consisting of the chief executive officer, executive vice presidents and senior vice presidents. As of 31 December 2019, Executive Management consisted of nine members including the chief executive officer. As of April 2019, Jesper Brandgaard retired from Novo Nordisk and Ludovic Helfgott was appointed executive vice president, head of Biopharm. As of August 2019, Lars Green resigned from Novo Nordisk and Monique Carter was appointed executive vice presi- dent, head of People & Organisation. The three executives who are based outside Denmark and who have responsibility for Biopharm, International Operations and North America Operations, respectively, are not registered as executives with the Danish Business Authority. Remuneration Novo Nordisk’s Remuneration Principles provide the framework for the remuner- ation of the Board and Executive Man- agement. The Remuneration Principles were most recently changed in March 2019, where the Annual General Meeting approved amendments in order to reflect the fact that the Research & Development Committee had become a permanent Board committee and in order to ensure that Novo Nordisk is able to reclaim incorrect pay-outs of incentives based on a misstatement of data regardless of whether this originates due to wilful misconduct or gross negligence. Moreover, the Annual General Meeting approved the denomi- nation of travel allowance in DKK instead of EUR. These principles are available at novonordisk.com/about-novo-nordisk/cor- porate-governance/remuneration.html. Novo Nordisk has prepared a separate Remuneration Report that describes the remuneration awarded or due during 2019 to the members of the Board and the Exec- utive Management of Novo Nordisk A/S as registered with the Danish Business Author- ity. This report also includes a description of key developments in remuneration in 2019, the actual remuneration of board members and executives, an overview of remuner- ation awarded during the previous five financial years, remuneration benchmarks and shareholdings by board members and executives. The Remuneration Report is available at: novonordisk.com/about-no- vo-nordisk/corporate-governance/remuner- ation.html. Read more in the Remuneration report Assurance The company’s financial reporting and the internal controls of financial reporting processes are audited by an independent audit firm elected at the Annual General Meeting. As part of Novo Nordisk’s com- mitment to its social and environmental Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo Nordisk Governance 37 Disclosure regarding change of control The EU Takeover Bids Directive, as partially implemented by the Danish Financial State- ments Act, requires listed companies to disclose information that may be of interest to the market and potential take-over bid- ders, in particular in relation to disclosure of change-of-control provisions. Novo Nordisk discloses that the Group has one significant agreement with a US payer which takes effect, alters or terminates upon a change of control of the Group. If effected, a takeover could – at the discre- tion of the relevant counterparty – lead to the termination of such agreement. Given the ownership structure of Novo Nordisk, the risk is considered to be remote. In relation to Executive Management, the current employment contracts allow severance payments of up to 36 months' fixed base salary plus pension contributions in the event of a merger, acquisition or takeover of Novo Nordisk. For information about the ownership structure of Novo Nordisk, see 'Shares and capital structure'. ment and recommending candidates for the Executive Management re- sides with the Chairmanship and not with the Nomination Committee. 3.4.7 Tasks of the Remuneration Commit- tee: responsibility for the remunera- tion policy applicable to employees in general resides with Executive Management and not with the Re- muneration Committee. 4.1.5 Termination payments: one executive employment contract entered into before 2008 allow for severance pay- ments of more than 24 months’ fixed base salary plus pension contribu- tion, and thus the total value of the remuneration relating to the notice period and of the severance payment exceeds two years of remuneration. Novo Nordisk complies with the corporate governance standards of NYSE applicable to foreign listed private issuers. A summa- ry of the significant ways in which Novo Nordisk’s corporate governance practices differ from the NYSE corporate governance listing standards can be found in the Statu- tory Corporate Governance Report. The Statutory Corporate Governance Report, in accordance with section 107b of the Danish Financial Statements Act, the applicable corporate governance codes for each stock exchange and an overview of Novo Nordisk’s compliance with and explanations for all applicable Nasdaq and NYSE Corporate Governance recommenda- tions, are all available at novonordisk.com/ about-novo-nordisk/corporate-governance/ Recommendations-and-practices.html Read more in the Corporate Governance report responsibility, the company voluntarily includes an assurance report for social and environmental reporting in the annual report. The assurance provider reviews whether the social and environmental per- formance information covers aspects that are deemed to be material and verifies the internal control processes for the informa- tion reported. Novo Nordisk’s internal audit function provides independent and objective assur- ance, primarily within internal control of financial processes, IT security and business ethics. To ensure that the internal financial audit function operates independently of Executive Management, its charter, audit plan and budget are approved by the Audit Committee. The Audit Committee must approve the appointment, remuneration and dismissal of the head of the internal audit function. Other types of assurance activity – quality audits and values audits, known as facili- tations – help to ensure that the company adheres to high quality standards and op- erates in accordance with the Novo Nordisk Way. Read more about the Novo Nordisk Way in 'Leading a sustainable business'. Compliance with corporate governance codes Novo Nordisk’s B shares are listed on Nasdaq Copenhagen and on the New York Stock Exchange (NYSE) as American Depos- itory Receipts (ADRs). Today, Novo Nordisk adheres to all Danish Corporate Governance Recommendations designated by Nasdaq Copenhagen except the following five recommendations: 3.3.2 Disclosure of additional information about the Board members: informa- tion on matters such as numbers of shares owned and changes during the year is disclosed in the Remuner- ation Report for 2019 and not in the management commentary. 3.4.2 Independence of Board committees: the majority of the members of the Nomination Committee and the Remuneration Committee are not independent. 3.4.6 Tasks of the Nomination Committee: responsibility for succession manage- Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo Nordisk Governance 38 Board of Directors Helge Lund — Chair Chair of the Board of Novo Nordisk A/S since 2018 (member for one year in 2014-2015 and again in 2017) and chair of the Nomination Committee since 2018 (member since 2017). Position and management duties: Operating advisor to Clayton Dubilier & Rice, US. Chair of the Board of BP p.l.c., UK. Member of the boards of P/F Tjaldur, Faroe Islands, Inkerman Holding AS, Norway, and Belron SA, Luxembourg. Member of the Board of Trustees of the International Crisis Group. Special competences: Extensive executive and board experience in large multinational companies and significant financial knowledge. Education: MBA from INSEAD, France (1991) and MA in Economics from the Norwegian School of Economics & Business Administration (NHH), Norway (1987). Jeppe Christiansen — Vice chair Vice chair and member of the Board of Novo Nordisk A/S since 2013. Chair of the Remuneration Committee since 2017 (member since 2015). Positions and management duties: Chief executive officer of Maj Invest Holding A/S as well as board member and/or executive director in three wholly owned subsidiaries of this company, all in Denmark. Chair of Haldor Topsøe A/S and Emlika ApS and board member of a wholly owned sub- sidiary of this company and of the boards of Novo Holdings A/S and KIRKBI A/S, all in Denmark. Member of the Board of Governors of Det Kgl. Vajsenhus, Denmark. Adjunct Professor, Department of Finance, Copenhagen Business School, Denmark. Special competences: Executive background and extensive experience within the financial sector, in particular in rela- tion to financial and capital market issues as well as insight into the investor perspective. Education: MSc in Economics from University of Copenhagen, Denmark (1985). Brian Daniels Member of the Board of Novo Nordisk A/S since 2016, member of the Remuneration Committee since 2018 and member of the Research & Development Committee since 2017. Position and management duties: Partner with 5AM Venture Management, LLC, and member of the board at Caballeta Bio Inc., both in the US. Special competences: Extensive experience in clinical development, medical affairs and corporate strategy across a broad range of therapeutics areas within the pharmaceutical industry, especially in the US. Education: MD from Washington University, St. Louis, US (1987), and MA in Metabolism and Nutritional Biochemistry (1981) and BSc in Life Sciences (1981), both from Massa- chusetts Institute of Technology, Cambridge, US. Laurence Debroux Member of the Board of Novo Nordisk A/S and member of the Audit Committee since 2019. Positions and management duties: Group chief financial officer, executive board member, of Heineken N.V., the Netherlands. Member of the board of Exor N.V., the Nether- lands, and of HEC Paris Business School, France. Special competences: Significant financial and accounting experience, extensive global experience within the pharma- ceutical industry and experience from executive positions in major international companies. Education: Master Degree from HEC Paris, Ecoles des Hautes Etudes Commerciales, France (1992). Andreas Fibig Member of the Board of Novo Nordisk A/S and member of the Audit Committee since 2018. Position and management duties: Chair and chief exec- utive officer of International Flavors & Fragrances Inc., US, Chair of the Board of the German American Chamber of Commerce, and Executive Committee member of the World Business Council for Sustainable Development (WBCSD). Special competences: Extensive global experience within biopharmaceutical companies, in-depth knowledge of strat- egy, sales and marketing and knowledge about how large international companies operate. Education: Degree in Marketing from Berlin School of Economics, Germany (1982). Sylvie Grégoire Member of the Board of Novo Nordisk A/S and of the Audit Committee since 2015, member of the Research & Development Committee since 2017, and member of the Nomination Committee since 2018. Positions and management duties: Chair of the board of Corvidia Therapeutics Inc., executive chair of the board of EIP Pharma, Inc., and member of the board of Perkin Elmer Inc., all in the US. Special competences: Deep knowledge of the regulatory environment in both the US and the EU, with experience of all phases of the product life cycle, including discovery, registration, pre-launch and managing the life cycle while on the market. She also has financial insight, including into P&L responsibility. Education: Pharmacy Doctorate degree from the State University of NY at Buffalo, US (1986), BA in Pharmacy from Laval University, Canada (1984), and Science College degree from Séminaire de Sherbrooke, Canada (1980). Competences and experience to be represented on the Board (shareholder-elected Board members only) Global business management, strategic operations and gov- ernance Healthcare industry and market access Research and development, technol- ogy and digitalisation M&A and external innovation sourcing People leadership and change management Finance and accounting Read more on competences and experience to be represented on the Board under “Nomination” in the Corporate Governance article. Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo Nordisk Governance 39 Liz Hewitt Member of the Board of Novo Nordisk A/S since 2012, chair of the Audit Committee since 2015 (member since 2012) and member of the Remuneration Committee since 2018. Position and management duties: Member of the board of Melrose Industries plc, UK, where she chairs the audit committee, and member of the board of National Grid plc, UK. External member of the House of Lords Commission, UK, where she chairs the audit committee. Special competences: Extensive experience within the field of medical devices, significant financial knowledge, including mergers and acquisitions, and knowledge about how large international companies operate. Education: FCA (UK Institute of Chartered Accountants) (1982), and BSc (Econ Hons) from the University College in London, UK (1977). Mette Bøjer Jensen Member of the Board of Novo Nordisk A/S (employee representative) and member of the Nomination Committee since 2018. Position and management duties: Wash & Sterilisation Specialist in Product Supply, Novo Nordisk A/S. Education: Graduate Programme (HD) in Business Admin- istration (Strategic management and business development) from Copenhagen Business School, Denmark (2010), and MSc in Biotechnology, Aalborg University, Denmark (2001). Kasim Kutay Member of the Board of Novo Nordisk A/S and member of the Nomination Committee since 2017. Positions and management duties: Chief executive officer of Novo Holdings A/S, Denmark. Member of the board of Novozymes A/S, Denmark, and of the Life Sciences Advisory Board of Gimv NV, Belgium. Special competences: Extensive experience as financial advisor to the pharmaceutical, biotechnology and medical device industries. Mr Kutay has also advised healthcare companies on an international basis including companies based in Europe, the US, Japan and India. Education: MSc in Economics (1987), and BSc in Economics (1986), both from the London School of Economics, UK. Anne Marie Kverneland Member of the Board of Novo Nordisk A/S since 2000 (employee representative) and member of the Remuneration Committee since 2017. Positions and management duties: Laboratory technician and full-time union representative in Novo Nordisk A/S. Member of the Board of Directors of the Novo Nordisk Foundation since 2014.  Education: Degree in medical laboratory technology from the Copenhagen University Hospital, Denmark (1980). Martin Mackay Member of the Board of Novo Nordisk A/S and chair of the Research & Development Committee since 2018. Positions and management duties: Co-founded Rallybio LLC, US, in January 2018 and serves as chair of the Board of the company and in an executive leadership role overseeing all research and non-research functions. Senior advisor to New Leaf Venture Partners, LLC, US. Member of the board and chairs the Science and Technology Committee of Charles River Laboratories International, Inc., US. Special competences: R&D executive with extensive expe- rience in building a pipeline, acquiring products and man- aging the portfolio of early-stage and late-stage projects in large international pharmaceutical companies. Education: Doctorate/PhD from University of Edinburgh, UK (1984), and BSc (First Class Honours) in Microbiology from Heriot-Watt University, Edinburgh, UK (1979). Thomas Rantzau Member of the Board of Novo Nordisk A/S (employee representative) and member of the Research & Development Committee since 2018. Positions and management duties: Area specialist in Product Supply, Novo Nordisk A/S. Education: Degree in food engineering from DTU, Denmark (2003) and diploma as dairy technician (1992). Stig Strøbæk Member of the Board of Novo Nordisk A/S since 1998 (employee representative) and member of the Audit Committee since 2013. Positions and management duties: Electrician and a full-time union representative in Novo Nordisk A/S. Education: Diploma in further training for board members from the Danish Employees’ Capital Pension Fund (LD) (2003), and diploma in electrical engineering (1984). Name (male/female) First elected Term Nationality Born Independence2 20173 Helge Lund (m) 2013 Jeppe Christiansen (m) 2019 Laurence Debroux (f) 2016 Brian Daniels (m) 2018 Andreas Fibig (m) 2015 Sylvie Grégoire (f) 2012 Liz Hewitt (f) 2018 Mette Bøjer Jensen (f) Kasim Kutay (m) 2017 Anne Marie Kverneland (f) 2000 2018 Martin Mackay (m) 2018 Thomas Rantzau (m) Stig Strøbæk (m) 1998 2020 2020 2020 2020 2020 2020 2020 2022 2020 2022 2020 2022 2022 Oct. 1962 Norwegian Nov. 1959 Danish Jul. 1969 French Feb. 1959 American German Feb. 1962 Canadian/American Nov. 1961 Nov. 1956 British Dec. 1975 Danish May 1965 British Jul. 1956 Danish Apr. 1956 American Mar. 1972 Danish Jan. 1964 Danish Independent Not independent 4 Independent Independent Independent 5, 6 Independent 5, 6 Independent 5, 6 Not independent 7 Not independent 4 Not independent 7 Independent Not independent 7 Not independent 5, 7 Board of Directors Chairman- ship Audit Committee Remuneration Committee Nomination Committee R&D Committee Meeting participation in 20191 8/8 6/8 8/8 8/8 6/6 8/8 8/8 7/8 8/8 8/8 8/8 8/8 8/8 8/8 8/8 3/3 2/4 4/4 4/4 4/4 3/3 3/3 3/3 3/3 5/5 5/5 5/5 5/5 6/6 6/6 6/6 6/6 1. Number of meetings attended by each board member out of the total number of meetings within the member's term. 2. As designated by Nasdaq Copenhagen in accordance with section 3.2.1 of Recommendations on Corporate Governance. 3. In addition, Helge Lund was a member of the Board for one year in 2014-2015 4. Member of the board or the management of Novo Holdings A/S. 5. Pursuant to the US Securities Exchange Act, Ms Hewitt, Ms Grégoire and Mr Fibig qualify as independent Audit Committee members, while Mr Strøbæk relies on an exemption from the independence requirements. 6. Ms Hewitt, Ms Grégoire and Mr Fibig qualify as independent Audit Committee members as defined under part 8 of the Danish Act on Approved Auditors and Audit Firms. 7. Elected by employees of Novo Nordisk. Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo Nordisk Governance 40 Executive Management Lars Fruergaard Jørgensen — President and chief executive officer (CEO) Born: November 1966. Other positions and management duties: Vice-chair of the supervisory board and member of the nomination committee of Carlsberg A/S, Denmark. Monique Carter — Executive vice president, People & Organisation Born: December 1973. Other management positions: No other management positions. Maziar Mike Doustdar* — Executive vice president, International Operations Born: August 1970. Other positions and management duties: No other management positions. Ludovic Helfgott* — Executive vice president, Biopharm  Born: July 1974. Other management positions: No other management positions. Karsten Munk Knudsen — Executive vice president, chief financial officer (CFO) Born: December 1971. Other positions and management duties: Chair of the board of NNE A/S, Denmark. Doug Langa* — Executive vice president, North America Operations Born: October 1966. Other positions and management duties: No other management positions. Camilla Sylvest — Executive vice president, Commercial Strategy & Corporate Affairs Born: November 1972. Other management duties: Member of the board of Danish Crown A/S, Denmark and Vice Chair of the board of the World Diabetes Foundation, Denmark. Mads Krogsgaard Thomsen — Executive vice president, chief science officer (CSO) Born: December 1960. Other management duties: Member of the board of Symphogen A/S, Denmark. Member of the editorial boards of international, peer- reviewed journals. Adjunct professor at the Faculty of Health and Medical Sciences of the University of Copenhagen, Denmark. Henrik Wulff — Executive vice president, Product Supply, Quality & IT Born: November 1970. Other management duties: Chair of the board of Novo Nordisk Pharmatech A/S and member of the board of Ambu A/S, both in Denmark. * Not registered as executive with the Danish Business Authority. Novo Nordisk Annual Report 2019Our businessConsolidated statements41 Consolidated financial, social and environmental statements 2019 Consolidated financial statements Income statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 42 Cash flow statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 43 Balance sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 44 Equity statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 45 Consolidated social statement (supplementary information) Statement of social performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 78 Notes to the Consolidated social statement Notes to the Consolidated financial statements Section 6 Section 1 Basis of preparation Principal accounting policies and key accounting estimates . . . . . . . . . . p 46 1.1 1.2 Changes in accounting policies and disclosures . . . . . . . . . . . . . . . . . . . . p 47 1.3 General accounting policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 47 Section 2 Results for the year 2.1 Net sales and rebates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 48 Segment information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 49 2.2 Research and development costs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 51 2.3 2.4 Employee costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 52 2.5 Other operating income, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 53 Income taxes and deferred income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . p 53 2.6 Section 3 Operating assets and liabilities Intangible assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 55 3.1 Property, plant and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 56 3.2 Leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 57 3.3 Inventories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 58 3.4 Trade receivables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 59 3.5 Retirement benefit obligations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 60 3.6 3.7 Provisions and contingent liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 61 3.8 Other liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 62 Section 4 Capital structure and financial items Share capital, distributions to shareholders and earnings per share . . . . p 63 4.1 Borrowings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 64 4.2 4.3 Financial risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 65 4.4 Derivative financial instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 67 4.5 Cash and cash equivalents, financial resources and free cash flow . . . . . p 68 4.6 Change in working capital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 68 4.7 Other non-cash items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 68 Financial assets and liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 69 4.8 Financial income and expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 70 4.9 Section 5 Other disclosures 5.1 Share-based payment schemes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 71 5.2 Commitments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 73 Related party transactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 74 5.3 5.4 Fee to statutory auditors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 74 5.5 Companies in the Novo Nordisk Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 75 Basis of preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 78 Section 7 Patients 7.1 Patients reached with Novo Nordisk’s Diabetes care products (estimate) .. p 80 7.2 Donations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 80 7.3 Animals purchased for research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 80 Section 8 Employees 8.1 8.2 Employees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 81 Frequency of occupational accidents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 81 Section 9 Responsible business Relevant employees trained in business ethics . . . . . . . . . . . . . . . . . . . . . . p 82 9.1 Business ethics reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 82 9.2 Facilitations of the Novo Nordisk Way . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 82 9.3 Supplier audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 82 9.4 Product recalls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 83 9.5 9.6 Failed inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 83 9.7 Company trust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 83 Total tax contribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 83 9.8 Consolidated environmental statement (supplementary information) Statement of environmental performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 84 Notes to the Consolidated environmental statement Section 10 Basis of preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 84 Section 11 Resources 11.1 Energy consumption for operations and share of renewable power . . . p 85 11.2 Water consumption for production sites . . . . . . . . . . . . . . . . . . . . . . . . . . . p 85 Section 12 Emissions and waste 12.1 CO2 emissions from operations and transportation . . . . . . . . . . . . . . . . . . p 85 12.2 Waste from production sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 86 Section 13 Responsible business 13.1 Breaches of regulatory limit values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p 86 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Income statement and statement of comprehensive income for the year ended 31 December DKK million Income statement Net sales Cost of goods sold Gross profit Sales and distribution costs Research and development costs Administrative costs Other operating income, net Operating profit Financial income Financial expenses Profit before income taxes Income taxes Net profit for the year Earnings per share Basic earnings per share (DKK) Diluted earnings per share (DKK) DKK million Statement of comprehensive income Net profit for the year Other comprehensive income: Items that will not be reclassified subsequently to the income statement: Remeasurements of retirement benefit obligations Items that will be reclassified subsequently to the income statement: Exchange rate adjustments of investments in subsidiaries Cash flow hedges, realisation of previously deferred (gains)/losses Cash flow hedges, deferred gains/(losses) incurred during the period Other items Tax on other comprehensive income, income/(expense) Other comprehensive income for the year, net of tax Total comprehensive income for the year 42 Note 2019 2018 2017 2.1, 2.2 2.2 2.2 2.2, 2.3 2.2 2.2, 2.5 4.9 4.9 2.6 4.1 4.1 122,021 20,088 101,933 31,823 14,220 4,007 600 52,483 65 3,995 48,553 9,602 38,951 111,831 17,617 111,696 17,632 94,214 29,397 14,805 3,916 1,152 47,248 2,122 1,755 47,615 8,987 94,064 28,340 14,014 3,784 1,041 48,967 1,246 1,533 48,680 10,550 38,628 38,130 16.41 16.38 15.96 15.93 15.42 15.39 Note 2019 2018 2017 38,951 38,628 38,130 3.6 (187) 87 103 4.4 4.4 2.6 226 1,677 (329) 9 (231) 1,165 491 (2,027) (1,677) (27) 755 (2,398) (632) 1,955 1,987 (577) (1,041) 1,795 40,116 36,230 39,925 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial StatementsCash flow statement for the year ended 31 December DKK million Cash flow statement Net profit for the year Adjustment of non-cash items: Income taxes in the income statement Depreciation, amortisation and impairment losses Other non-cash items Change in working capital Interest received Interest paid Income taxes paid Net cash generated from operating activities Purchase of intangible assets Proceeds from sale of property, plant and equipment Purchase of property, plant and equipment Proceeds from other financial assets Purchase of other financial assets Sale of marketable securities Investment in associated companies Proceeds from the divestment of Group and associated companies Dividend received from associated companies Net cash used in investing activities Purchase of treasury shares Dividends paid Repayment of borrowings, net Net cash used in financing activities Net cash generated from activities Cash and cash equivalents at the beginning of the year Reclassification of bank overdraft to financing activities Exchange gains/(losses) on cash and cash equivalents Cash and cash equivalents at the end of the year 43 Note 2019 2018 2017 2.6 3.1, 3.2 4.7 4.6 2.6 3.1 3.2 5.3 5.3 4.1 4.1 4.2 4.5 4.5 38,951 38,628 38,130 9,602 5,661 7,032 (3,388) 64 (204) (10,936) 8,987 3,925 6,098 (3,370) 51 (89) (9,614) 10,550 3,182 2,027 (3,634) 101 (87) (9,101) 46,782 44,616 41,168 (2,299) 4 (8,932) 148 (350) — (97) (3) 20 (2,774) 13 (9,636) 178 (248) — — 368 19 (1,022) 9 (7,626) 73 (40) 2,009 — — 26 (11,509) (12,080) (6,571) (15,334) (19,409) (741) (15,567) (19,048) 94 (16,845) (18,844) — (35,484) (34,521) (35,689) (211) 15,629 — (7) (1,985) 17,158 412 44 (1,092) 18,461 — (211) 4.5 15,411 15,629 17,158 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial StatementsBalance sheet at 31 December DKK million Assets Intangible assets Property, plant and equipment Investments in associated companies Deferred income tax assets Other receivables and prepayments Other financial assets Total non-current assets Inventories Trade receivables Tax receivables Other receivables and prepayments Derivative financial instruments Cash at bank Total current assets Total assets Equity and liabilities Share capital Treasury shares Retained earnings Other reserves Total equity Borrowings Deferred income tax liabilities Retirement benefit obligations Provisions Total non-current liabilities Borrowings Trade payables Tax payables Other liabilities Derivative financial instruments Provisions Total current liabilities Total liabilities Total equity and liabilities 44 Note 2019 2018 3.1 3.2 2.6 4.8 4.8 3.4 3.5, 4.8 4.8 4.3, 4.4, 4.8 4.3, 4.5, 4.8 5,835 50,551 474 4,121 841 1,334 63,156 17,641 24,912 806 3,434 188 15,475 5,145 41,891 531 2,893 — 1,242 51,702 16,336 22,786 1,013 3,090 204 15,638 62,456 59,067 125,612 110,769 4.1 4.1 4.2, 4.8 2.6 3.6 3.7 4.2, 4.8 4.8 3.8, 4.8 4.4, 4.8 3.7 480 (10) 57,817 (694) 57,593 3,009 80 1,334 4,613 9,036 1,474 6,358 4,212 15,085 734 31,120 58,983 68,019 490 (11) 53,406 (2,046) 51,839 — 118 1,256 3,392 4,766 515 6,756 4,610 14,098 2,024 26,161 54,164 58,930 125,612 110,769 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial StatementsEquity statement at 31 December DKK million Share capital Treasury shares Retained earnings 45 Total 45,269 38,130 1,795 39,925 (18,844) 292 18 (16,845) — Other reserves Exchange rate adjust- ments Cash flow hedges Tax and other items Total other reserves (924) (1,915) 1,496 (1,343) (632) (632) 3,942 (1,618) 3,942 (1,618) 1,692 1,692 48,977 (1,556) 2,027 (122) 349 49,815 (90) 38,628 87 38,625 (19,048) 414 (5) (15,557) 491 491 (3,704) (3,704) 90 728 818 90 (2,485) — 38,628 (2,398) (2,395) 36,230 (19,048) 414 (5) (15,567) — 53,406 (1,065) (1,677) 696 (2,046) 51,839 46,111 38,130 103 38,233 (18,844) 292 18 (16,833) 510 (9) (10) 500 (12) 10 (11) (10) 490 (10) 10 (11) 38,951 (187) 38,764 (19,409) 363 18 (15,325) (9) 10 226 226 1,348 1,348 (222) (222) 1,352 1,352 38,951 1,165 40,116 (19,409) 363 18 (15,334) — (10) 57,817 (839) (329) 474 (694) 57,593 (10) 480 2017 Balance at the beginning of the year Net profit for the year Other comprehensive income for the year Total comprehensive income for the year Transactions with owners: Dividends (note 4.1) Share-based payments (note 5.1) Tax related to restricted stock units (note 2.6) Purchase of treasury shares (note 4.1) Reduction of the B share capital (note 4.1) Balance at the end of the year 2018 Change in accounting policy, IFRS 9 (net of tax) Net profit for the year Other comprehensive income for the year Total comprehensive income for the year Transactions with owners: Dividends (note 4.1) Share-based payments (note 5.1) Tax related to restricted stock units (note 2.6) Purchase of treasury shares (note 4.1) Reduction of the B share capital (note 4.1) Balance at the end of the year 2019 Net profit for the year Other comprehensive income for the year Total comprehensive income for the year Transactions with owners: Dividends (note 4.1) Share-based payments (note 5.1) Tax related to restricted stock units (note 2.6) Purchase of treasury shares (note 4.1) Reduction of the B share capital (note 4.1) Balance at the end of the year Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements46 Section 1 Basis of preparation 1.1 Principal accounting policies and key accounting estimates The consolidated financial statements included in this Annual Report have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and in accordance with IFRS as endorsed by the EU and further requirements in the Danish Financial Statements Act. All entities in the Novo Nordisk Group follow the same Group accounting policies. Measurement basis The consolidated financial statements have been prepared on the historical cost basis except for derivative financial instruments, equity investments and trade receivables in a factoring portfolio, which are measured at fair value. Except for the changes described in note 1.2, the principal accounting policies set out below have been applied consistently in the preparation of the consolidated financial statements for all the years presented. Principal accounting policies Novo Nordisk’s accounting policies are described in each of the individual notes to the consolidated financial statements. Accounting policies listed in the table below are regarded as the principal accounting policies applied by the Management. Key accounting estimates and judgements The use of reasonable estimates and judgements is an essential part of the prepa- ration of the consolidated financial statements. Given the uncertainties inherent in Novo Nordisk’s business activities, Management must make certain estimates regarding valuation and judgements on the reported amounts of assets, liabilities, net sales, expenses and related disclosures. The key accounting estimates identified are those that have a significant risk of resulting in a material adjustment to the measurement of assets and liabilities in the following reporting period. Management bases its estimates on historical experience and various other assumptions that are held to be reasonable under the circumstances. The estimates and underlying assumptions are reviewed on an ongoing basis. If necessary, changes are recognised in the period in which the estimate is revised. Management considers the key accounting estimates to be reasonable and appropriate based on currently available information. The actual amounts may differ from the amounts estimated as more detailed information becomes available. In addition, Management makes judgements and estimates in the process of applying the entity’s accounting policies, for example regarding recognition and measurement of deferred income tax assets or the classification of transactions. Management regards those listed below as the key accounting estimates and judgements used in the preparation of the consolidated financial statements. Please refer to the specific notes for further information on the key accounting estimates and judgements as well as assumptions applied. Principal accounting policies Key accounting estimates and judgements Note Estimation risk US net sales and rebates Income taxes and deferred income taxes Intangible assets Inventories Provisions and contingent liabilities Estimate of US sales deductions and provisions for sales rebates Judgement and estimate regarding deferred income tax assets and provision for uncertain tax positions Estimate regarding impairment of assets Estimate of indirect production costs capitalised and inventory write-down Estimate of ongoing legal disputes, litigation and investigations 2.1 High 2.6 Medium 3.1 Low 3.4 Low 3.7 High Applying materiality The consolidated financial statements are a result of processing large numbers of transactions and aggregating those transactions into classes according to their nature or function. The transactions are presented in classes of similar items in the consolidated financial statements. If a line item is not individually material, it is aggregated with other items of a similar nature in the consolidated financial statements or in the notes. There are substantial disclosure requirements throughout IFRS. Management provides specific disclosures required by IFRS unless the information is not appli- cable or is considered immaterial to the economic decision-making of the users of these financial statements. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements47 1.2 Changes in accounting policies and disclosures Adoption of new or amended IFRSs Management has assessed the impact of new or amended and revised accounting standards and interpretations (IFRSs) issued by the IASB and IFRSs endorsed by the European Union. The following recognition exemptions and practical expedients were applied on transition: • Applied a single discount rate to a portfolio of leases with similar characteristics • Excluded initial direct costs from measuring the right-of-use asset at the date of initial application • Used hindsight when determining the lease term if the contract contains option to extend or terminate • Exempted short-term lease contracts with a remaining duration of 12 months IFRS 16 'Leases' As of 1 January 2019 Novo Nordisk applied IFRS 16 'Leases' for the first time. or less as at 1 January 2019 Reconciliation of lease liabilities pursuant to IFRS 16 on transition: The Group has implemented IFRS 16 'Leases' using the modified retrospective approach. DKK million Under this method, the cumulative effect of initially applying the standard is recognised at 1 January 2019. Right-of-use assets and lease liabilities have been recognised for those leases previously classified as operating leases, except for short-term leases and leases of low value assets. The right-of-use assets have been recognised based on the amount equal to the lease liabilities, adjusted for any related prepaid and accrued lease payments previously recognised. Lease liabilities are recognised based on the present value of the remaining lease payments, discounted using the incremental borrowing rate as of 1 January 2019. The comparative information has not been restated. Impact from IFRS 16 as of 1 January 2019: DKK million Property, plant and equipment Prepayments Borrowings (non-current) Borrowings (current) Other liabilities Net assets 1 January 2019 3,778 (5) 3,330 658 (215) — On transition to IFRS 16, the Group recognised an additional DKK 3,778 million of right-of-use assets and DKK 3,988 million of lease liabilities. The change in policy has had an insignificant impact on the income statement. In the cash flow statement the principal repayment of lease liabilities is presented in 'net cash used in financing activities', whereas the full lease payment under previous policies was presented in 'net cash generated from operating activities'. The change in policy has had no impact on free cash flow due to a change in definition, as described in non-IFRS financial measures. Refer to note 3.3 for the new accounting policies. Operating lease commitment as disclosed in the Group's 2018 consolidated financial statements Short-term leases Leases of low value assets Service commitments excluded Other Lease liability on transition (undiscounted) Discounted using the Group's incremental borrowing rate at 1 January 2019 Lease liability recognised on transition 1 January 2019 4,896 (142) (43) (220) (31) 4,460 2.95% 3,988 On transition to IFRS 16, Novo Nordisk recognised lease liabilities in relation to leases which had previously been classified as operating leases in accordance with IAS 17. The lease liabilities were measured at the present value of the future discounted lease payments using Novo Nordisk's incremental borrowing rate at 1 January 2019. The weighted average incremental borrowing rate applied on transition to IFRS 16 was 2.95%. Other new interpretations effective 1 January 2019 It is assessed that application of other new interpretations effective on 1 January 2019 has not had a material impact on the Consolidated financial statements in 2019. Furthermore, Management does not anticipate any significant impact on future periods from the adoption of these new interpretations. Adoption of new or amended IFRSs in prior periods As of 1 January 2018 Novo Nordisk applied IFRS 9 'Financial Instruments' and IFRS 15 'Revenue from contracts with customers' for the first time. The impact of the implementation of IFRS 9 and IFRS 15 was immaterial in relation to recognition and measurement. 1.3 General accounting policies Principles of consolidation The consolidated financial statements incorporate the financial statements of the parent company Novo Nordisk A/S and entities controlled by Novo Nordisk A/S. Control exists when Novo Nordisk has effective power over the entity and has the right to variable returns from the entity. Where necessary, adjustments are made to bring the financial statements of subsidiaries in line with the Novo Nordisk Group's accounting policies. All intra- Group transactions, balances, income and expenses are eliminated in full when consolidated. The results of subsidiaries acquired or disposed of during the year are included in the Consolidated income statement from the effective date of acquisition and up to the effective date of disposal. Translation of foreign currencies Functional and presentation currency Items included in the financial statements of Novo Nordisk's entities are measured using the currency of the primary economic environment in which the entity oper- ates (functional currency). The consolidated financial statements are presented in Danish kroner (DKK), which is also 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 prevailing at the transaction dates. 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 are recognised in the income statement. Foreign currency differences arising from the translation of effective qualifying cash flow hedges are recognised in other comprehensive income. Translation of Group companies Financial statements of foreign subsidiaries are translated into DKK at the exchange rates prevailing at the end of the reporting period for balance sheet items, and at average exchange rates for income statement items. All effects of exchange rate adjustments are recognised in other comprehensive income, i.e.: • The translation of foreign subsidiaries’ net assets at the beginning of the year to the exchange rates at the end of the reporting period. • The translation of foreign subsidiaries’ statements of comprehensive income at average to year-end exchange rates. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial StatementsSection 2 Results for the year 2.1 Net sales and rebates Accounting policies Revenue from sale of goods is recognised when Novo Nordisk has transferred control of products sold to the buyer and it is probable that Novo Nordisk will collect the consideration to which it is entitled for transferring the products. Control of the products is transferred at a point in time, typically on delivery. The amount of sales to be recognised is based on the consideration Novo Nordisk expects to receive in exchange for its goods. When sales are recognised, Novo Nordisk also records estimates for a variety of sales deductions, including product returns as well as rebates and discounts to government agencies, wholesalers, health insurance companies, managed healthcare organisations and retail customers. Sales deductions are recognised as a reduction of gross sales to arrive at net sales, by assessing the expected value of the sales deductions (variable consideration). Where contracts contain customer acceptance criteria, Novo Nordisk recognises sales when the acceptance criteria are satisfied. In some markets, Novo Nordisk sells products on a sale-or-return basis. Where there is historical experience or a reasonably accurate estimate of future returns, estimated product returns are recorded as a reduction in sales. Where shipments of new products are made on a sale-or-return basis, without sufficient historical experience for estimating sales returns, revenue is recorded based on estimated demand and acceptance rates for well-established products with similar market characteristics. If similar market characteristics do not exist, revenue is recorded when there is evidence of consumption or when the right of return has expired. Key accounting estimates of sales deductions and provisions for sales rebates Sales deductions are estimated and provided for at the time the related sales are recorded. These estimates of unsettled rebate, discount and product return obliga- tions require use of significant judgement, as not all conditions are known at the time of sale, for example total sales volume to a given customer. The estimates are based on analyses of existing contractual obligations and histor- ical experience. Provisions are calculated on the basis of a percentage of sales for each product as defined by the contracts with the various customer groups. Provisions for sales rebates are adjusted to actual amounts as rebates, discounts and returns are processed. Novo Nordisk considers the provisions established for sales rebates to be reason- able and appropriate based on currently available information. However, the actual amount of rebates and discounts may differ from the amounts estimated by Management as more detailed information becomes available. Gross-to-net sales reconciliation DKK million 2019 2018 2017 Gross sales 270,431 230,701 216,174 US Managed Care and Medicare US wholesaler charge-backs US Medicaid rebates Other US discounts and sales returns Non-US rebates, discounts and sales returns (84,202) (33,772) (14,365) (65,207) (29,469) (11,950) (53,077) (28,324) (12,491) (8,280) (6,606) (5,771) (7,791) (5,638) (4,815) Total gross-to-net sales adjustments (148,410) (118,870) (104,478) Net sales 122,021 111,831 111,696 Sales discounts and sales rebates are predominantly issued in the US. As such, rebates amount to 71% of gross sales in the US (68% in 2018 and 64% in 2017). Novo Nordisk sales are impacted by exchange rate changes. For developments in key currencies refer to note 4.3. 48 Pricing mechanisms in the US market In the US, sales rebates are paid in connection with public healthcare insurance programmes, namely Medicare and Medicaid, as well as rebates to pharmacy benefit managers (PBMs) and managed healthcare plans. Key customers in the US include private payers, PBMs and government payers. PBMs and managed health- care plans play a role in negotiating price concessions with drug manufacturers for both the commercial and government channels, and determine which drugs are covered on their formularies (or 'preferred drug lists'). US Managed Care and Medicare For Managed Care and Medicare, rebates are offered to a number of PBMs and managed healthcare plans. These rebate programmes allow the customer to receive a rebate after attaining certain performance parameters relating to formulary status or pre-established market shares thresholds. Rebates are esti- mated according to the specific terms in each agreement, historical experience, anticipated channel mix, growth rates and market share information. Novo Nordisk adjusts the provision periodically to reflect actual sales performance. Managed Care and Medicare rebates are generally settled around 100 days from the transaction date. US wholesaler charge-backs Wholesaler charge-backs relate to contractual arrangements between Novo Nordisk and indirect customers in the US whereby products are sold at contract prices lower than the list price originally charged to wholesalers. A wholesaler charge-back represents the difference between the invoice price to the wholesaler and the indirect customer’s contract price. Accruals are calculated for estimated charge-backs using a combination of factors such as historical experience, current wholesaler inventory levels, contract terms and the value of claims received but not yet processed. Wholesaler charge-backs are generally settled within 30 days of the liability being incurred. US Medicaid rebates Medicaid is a government insurance programme. Medicaid rebates have been estimated using a combination of historical experience, product and population growth, price increases, and the impact of contracting strategies. The calculation also involves interpretation of relevant regulations that are subject to changes in interpretative guidance from government authorities. Novo Nordisk adjusts the provision periodically to reflect actual sales performance. Medicaid rebates are generally settled around 150 days from the transaction date. Other US discounts and sales returns Other discounts are provided to wholesalers, hospitals, pharmacies, etc. They are usually linked to sales volume or provided as cash discounts. Accruals are calculated based on historical data and recorded as a reduction in gross sales at the time the related sales are recorded. Sales returns are related to damaged or expired products. Arrangements with certain healthcare providers may require Novo Nordisk to make refunds to the healthcare providers if anticipated treatment outcomes do not meet predefined targets. Provisions for sales rebates DKK million 2019 2018 2017 At the beginning of the year 25,760 20,374 20,063 Additional provisions, including increases to existing provisions Amount paid during the year Adjustments, including unused amounts reversed during the year Effect of exchange rate adjustment 102,782 (98,655) 82,631 (78,647) 63,880 (61,059) 381 610 386 1,016 (117) (2,393) At the end of the year 30,878 25,760 20,374 Unsettled rebates are recognised as Provisions when the timing or amount is uncertain (note 3.7). Where absolute amounts are known, the rebates are recognised as other liabilities. Wholesaler charge-backs are netted against trade receivable balances. Provisions for sales rebates thus includes US Managed Care, Medicare, Medicaid and other minor US rebate types, as well as rebates in a number of European countries and Canada. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements49 2.2 Segment information Accounting policies Operating segments are reported in a manner consistent with the internal reporting provided to Executive Management and the Board of Directors. We consider Executive Management to be the operating decision-making body, as all significant decisions regarding business development and direction are taken in this forum. Business segments Novo Nordisk operates in two business segments based on therapies: Diabetes and Obesity care and Biopharm, representing the entirety of the Group's operations. The segments include research, development, manufacturing and marketing of products within the following areas: - Diabetes and Obesity care: insulin, GLP-1 and related delivery systems, oral anti- diabetic products (OAD), obesity and other serious chronic diseases. - Biopharm: haemophilia, growth disorders and hormone replacement therapy. Segment performance is evaluated on the basis of operating profit consistent with the Consolidated financial statements. Financial income and expenses and income taxes are managed at Group level and are not allocated to business segments. There are no sales or other transactions between the business segments. Costs have been split between business segments according to a specific allocation. In addition, a small number of corporate overhead costs are allocated systematically between 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, inventories, trade receivables and other receivables and prepayments. Business segments DKK million Segment sales Long-acting insulin - of which Tresiba® - of which Xultophy® - of which Levemir® Premix insulin - of which Ryzodeg® - of which NovoMix®/NovoLog Mix® Fast-acting insulin - of which Fiasp® - of which NovoRapid®/NovoLog® Human insulin Total insulin Victoza® Ozempic® Rybelsus® Total GLP-1 Other Diabetes care Total Diabetes care Obesity care (Saxenda®) 2019 2018 2017 2019 2018 2017 2019 2018 2017 Diabetes and Obesity care Biopharm Total 20,776 9,259 2,210 9,307 10,578 993 9,585 19,303 1,243 18,060 9,036 59,693 21,934 11,237 50 33,221 4,247 97,161 5,679 20,844 8,035 1,614 11,195 10,194 714 9,480 19,353 590 18,763 9,265 59,656 24,333 1,796 — 26,129 4,250 90,035 3,869 22,174 7,327 729 14,118 10,749 492 10,257 20,124 99 20,025 9,793 62,840 23,173 — — 23,173 4,302 90,315 2,562 Diabetes and Obesity care total sales 102,840 93,904 92,877 Haemophilia - of which NovoSeven® - of which NovoEight® Growth disorders (Norditropin®) Other Biopharm Biopharm total sales Segment key figures Total net sales Cost of goods sold Sales and distribution costs Research and development costs Administrative costs Other operating income, net Operating profit Operating margin Depreciation, amortisation and impairment losses expensed Additions to Intangible assets and Property, plant and equipment Assets allocated to business segments Non-allocated assets1 Total assets 10,281 8,119 1,525 7,275 1,625 19,181 19,181 3,779 3,094 2,092 661 291 9,846 51.3% 9,576 7,881 1,354 6,834 1,517 10,469 9,206 1,103 6,655 1,695 17,927 18,819 17,927 2,901 3,001 2,583 650 614 9,406 52.5% 18,819 2,618 2,865 2,656 641 575 10,614 56.4% 122,021 20,088 31,823 14,220 4,007 600 52,483 43.0% 111,831 17,617 29,397 14,805 3,916 1,152 47,248 42.2% 111,696 17,632 28,340 14,014 3,784 1,041 48,967 43.8% 102,840 16,309 28,729 12,128 3,346 309 42,637 41.5% 93,904 14,716 26,396 12,222 3,266 538 37,842 40.3% 92,877 15,014 25,475 11,358 3,143 466 38,353 41.3% 3,916 3,210 2,536 1,745 715 646 5,661 3,925 3,182 9,644 86,700 9,219 71,706 7,565 61,542 1,518 16,514 3,107 17,542 2,226 14,994 11,162 103,214 22,398 125,612 12,326 89,248 21,521 110,769 9,791 76,536 25,819 102,355 1. The part of total assets that remains unallocated to either of the two business segments includes investments in associated companies, deferred income tax assets, other financial assets, tax receivables, derivative financial instruments and cash at bank. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements 50 Net sales disclosures Sales to external customers attributed to the US are collectively the most material to the Group. The US and Mainland China are the only territories where sales contribute 10% or more of total net sales. In 2019, Novo Nordisk had three major wholesalers distributing products, repre- senting 19%, 14% and 12% respectively of total net sales (20%, 13% and 13% in 2018 and 21%, 13% and 12% in 2017). Sales to these three wholesalers are within both Diabetes and Obesity care and Biopharm. Net sales to be recognised from fulfilling existing customer contracts containing fixed or minimum sales volumes, with an original term greater than 12 months, is expected to be DKK 544 million within 12 months (2018: DKK 767 million) and DKK 32 million thereafter (2018: DKK 742 million). Net sales will be impacted by exchange rate fluctuations. Novo Nordisk has an accounting policy to recognise the income statement impact of foreign currency hedging within financial items. Please refer to notes 4.3, 4.4 and 4.9 for more details on hedging. 2.2 Segment information (continued) Geographical areas Novo Nordisk operates in two main commercial units: • International Operations ◦ Region Europe: the EU, EFTA, Albania, Bosnia-Herzegovina, Macedonia, Serbia, Montenegro and Kosovo ◦ Region AAMEO: countries in Africa, Asia, Middle East & Oceania ◦ Region China: Mainland China, Taiwan and Hong Kong ◦ Region Japan & Korea: Japan and South Korea ◦ Region Latin America: countries in South America, Central America and Mexico • North America Operations (the US and Canada) Sales are attributed to geographical regions according to the location of the customer. Allocation of property, plant and equipment, trade receivables, allow- ance for trade receivables and total assets is based on the location of the assets. The country of domicile is Denmark, which is part of Region Europe. Denmark is immaterial to Novo Nordisk’s activities in terms of geographical size and the operational business segments. 99.7% of total sales are realised outside Denmark. Of total property, plant and equipment, DKK 25,175 million is located in Denmark, where the Group's main production, filling, packaging, moulding and assembly facilities are located. Geographical areas 2019 2018 2017 2019 2018 2017 2019 2018 2017 2019 2018 2017 International Operations DKK million Total International Operations Region Europe Region AAMEO Region China Sales by business segment: Long-acting insulin - of which Tresiba® - of which Xultophy® - of which Levemir® Premix insulin - of which Ryzodeg® - of which NovoMix®/NovoLog Mix® Fast-acting insulin - of which Fiasp® - of which NovoRapid®/NovoLog® Human insulin Total insulin Victoza® Ozempic® Rybelsus® Total GLP-1 Other Diabetes care Total Diabetes care Obesity care (Saxenda®) 9,035 3,477 1,493 4,065 9,707 993 8,714 10,304 617 9,687 7,361 36,407 7,249 1,143 — 8,392 3,389 7,942 2,764 1,085 4,093 8,862 714 8,148 9,332 357 8,975 7,348 7,416 2,345 567 4,504 8,959 492 8,467 9,156 91 9,065 7,856 33,484 6,240 39 — 33,387 5,708 — — 6,279 3,360 5,708 3,359 4,720 1,685 1,266 1,769 1,595 68 1,527 4,732 585 4,147 1,380 12,427 3,967 965 — 4,932 562 4,282 1,246 1,007 2,029 1,701 56 1,645 4,558 357 4,201 1,580 3,895 966 560 2,369 1,878 26 1,852 4,366 91 4,275 1,770 12,121 3,720 39 — 11,909 3,451 — — 3,759 579 3,451 605 1,526 406 146 974 2,961 429 2,532 2,622 27 2,595 2,230 9,339 1,005 4 — 1,009 691 1,281 337 58 886 2,606 275 2,331 2,194 — 2,194 2,065 8,146 841 — — 841 675 1,229 261 7 961 2,686 183 2,503 2,261 — 2,261 1,922 8,098 858 — — 858 754 1,059 87 — 972 4,306 4 4,302 1,753 — 1,753 2,847 9,965 898 — — 898 1,647 814 16 — 798 3,783 — 3,783 1,450 — 1,450 2,821 8,868 521 — — 521 1,672 694 2 — 692 3,555 — 3,555 1,253 — 1,253 3,096 8,598 309 — — 309 1,566 48,188 2,083 43,123 1,211 42,454 569 17,921 334 16,459 207 15,965 102 11,039 802 9,662 418 9,710 190 12,510 9 11,061 1 10,473 — Diabetes and Obesity care total 50,271 44,334 43,023 18,255 16,666 16,067 11,841 10,080 9,900 12,519 11,062 10,473 Haemophilia - of which NovoSeven® - of which NovoEight® Growth disorders Other Biopharm 5,946 4,502 1,143 4,225 1,122 5,572 4,424 1,046 4,000 1,017 5,446 4,597 788 4,105 1,113 2,762 1,767 790 1,466 779 2,781 1,944 776 1,511 721 2,828 2,245 551 1,572 722 1,305 1,130 146 691 252 1,177 1,049 109 680 216 1,163 1,097 52 676 279 Biopharm total 11,293 10,589 10,664 5,007 5,013 5,122 2,248 2,073 2,118 284 269 15 36 5 325 199 194 5 20 4 223 216 215 1 15 5 236 Total sales by business and geographical segment 61,564 54,923 53,687 23,262 21,679 21,189 14,089 12,153 12,018 12,844 11,285 10,709 Total sales growth as reported 12.1% 2.3% 2.2% 7.3% 2.3% 2.5% 15.9% 1.1% 3.8% 13.8% 5.4% 2.4% Property, plant and equipment Trade receivables, net Allowance for doubtful trade receivables Total assets 30,972 10,508 28,851 9,884 27,929 9,423 26,730 3,611 25,500 3,388 24,665 3,273 (1,471) 85,541 (1,358) 80,420 (1,262) 81,743 (196) 67,007 (241) 64,327 (223) 65,600 1,003 3,595 (967) 6,729 723 3,237 566 3,468 (866) 5,635 (823) 5,876 2,101 1,760 — 6,820 1,812 1,841 1,884 1,541 — 6,003 — 5,927 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements Geographical areas (continued) 2019 2018 2017 2019 2018 2017 2019 2018 2017 2019 2018 2017 International Operations (continued) North America Operations DKK million Region Japan & Korea Region Latin America Total Of which the US 51 Sales by business segment: Long-acting insulin - of which Tresiba® - of which Xultophy® - of which Levemir® Premix insulin - of which Ryzodeg® - of which NovoMix®/NovoLog Mix® Fast-acting insulin - of which Fiasp® - of which NovoRapid®/NovoLog® Human insulin Total insulin Victoza® Ozempic® Rybelsus® Total GLP-1 Other Diabetes care Total Diabetes care Obesity care (Saxenda®) 930 821 11 98 722 457 265 790 5 785 170 2,612 748 — — 748 421 3,781 282 857 751 — 106 650 351 299 779 — 779 187 2,473 614 — — 614 368 872 739 — 133 697 253 444 941 — 941 232 2,742 590 — — 590 376 3,455 175 3,708 — 800 478 70 252 123 35 88 407 — 407 734 2,064 631 174 — 805 68 2,937 656 708 414 20 274 122 32 90 351 — 351 695 1,876 544 — — 544 66 726 377 — 349 143 30 113 335 — 335 836 11,741 5,782 717 5,242 871 — 871 8,999 626 8,373 1,675 2,040 500 23,286 14,685 — 10,094 50 — 12,902 5,271 529 7,102 1,332 — 1,332 10,021 233 9,788 1,917 26,172 18,093 1,757 — 14,758 4,982 162 9,614 1,790 — 1,790 10,968 8 10,960 1,937 29,453 17,465 — — 500 58 24,829 858 48,973 3,596 19,850 890 17,465 943 46,912 2,658 47,861 1,993 2,486 410 2,598 277 11,271 5,500 708 5,063 839 — 839 8,592 597 7,995 1,552 22,254 14,217 9,599 50 23,866 705 46,825 3,348 12,600 5,192 528 6,880 1,294 — 1,294 9,634 211 9,423 1,778 25,306 17,561 1,634 — 14,466 4,970 162 9,334 1,743 — 1,743 10,574 — 10,574 1,766 28,549 16,929 — — 19,195 733 16,929 782 45,234 2,446 46,260 1,828 Diabetes and Obesity care total 4,063 3,630 3,708 3,593 2,896 2,875 52,569 49,570 49,854 50,173 47,680 48,088 Haemophilia - of which NovoSeven® - of which NovoEight® Growth disorders Other Biopharm 560 377 116 1,746 84 557 400 135 1,538 72 681 497 169 1,579 104 1,035 959 76 286 2 858 837 21 251 4 Biopharm total 2,390 2,167 2,364 1,323 1,113 558 543 15 263 3 824 4,335 3,617 382 3,050 503 4,004 3,457 308 2,834 500 5,023 4,609 315 2,550 582 4,031 3,454 358 3,035 247 3,723 3,278 291 2,823 262 4,852 4,451 315 2,543 348 7,888 7,338 8,155 7,313 6,808 7,743 Total sales by business and geographical segment 6,453 5,797 6,072 4,916 4,009 3,699 60,457 56,908 58,009 57,486 54,488 55,831 Total sales growth as reported 11.3% (4.5%) (2.5%) 22.6% 8.4% 3.0% 6.2% (1.9%) (2.1%) 5.5% (2.4%) (2.4%) Property, plant and equipment Trade receivables, net Allowance for doubtful trade receivables Total assets 436 495 (7) 1,543 201 504 (5) 1,503 146 279 (5) 1,304 702 1,047 (301) 3,442 615 914 (246) 2,952 668 862 (211) 3,036 19,579 14,404 (13) 40,071 13,040 12,902 (12) 30,349 7,318 10,742 (32) 20,612 19,531 13,999 (13) 39,460 13,023 12,643 (12) 29,732 7,298 10,517 (32) 20,180 2.3 Research and development costs Accounting policies Novo Nordisk’s research and development is mainly focused on: • Insulins, GLP-1s and other therapeutic new antidiabetic drugs for diabetes treatment. • GLP-1s, combinations and new modes of action for Obesity care. • Blood-clotting factors and new modes of action for haemophilia treatment. • Human growth hormone for treatment of growth disorders. • New modes of action including GLP-1 and stem cells for treatment of NASH, cardiovascular disease, chronic kidney disease and Parkinson's disease, among others. to significant regulatory uncertainties and other uncertainties inherent in the devel- opment of new products. This means that they do not qualify for capitalisation as intangible assets until marketing approval by a regulatory authority is obtained or considered highly probable. Costs for post-approval activities that are required by authorities as a condition for obtaining regulatory approval are recognised as research and development costs. Research and development activities are carried out by Novo Nordisk’s research and development centres, mainly in Denmark, the US, the UK and China. Research and development trials are carried out all over the world. Novo Nordisk also enters into partnerships and licence agreements. The research activities mainly utilise biotechnological methods based on advanced protein chemistry and protein engineering. These methods have played a key role in the development of the production technology used to manufacture insulin, GLP-1, recombinant blood-clotting factors and human growth hormone. Novo Nordisk expenses all research costs. In line with industry practice, internal and subcontracted development costs are also expensed as they are incurred, due Research and development costs primarily comprise employee costs, and internal and external costs related to execution of studies, including manufacturing costs and facility costs of the research centres. The costs also comprise amortisation, depreciation and impairment losses related to software and property, plant and equipment used in the research and development activities. Impairment losses recognised on intangible assets not yet available for use related to research and development projects are presented in research and development costs. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements52 2.3 Research and development costs (continued) 2.4 Employee costs Certain research and development activities are recognised outside research and development costs: • Royalty expenses paid to partners after regulatory approval are expensed as cost of goods sold. • Royalty income received from partners is recognised as part of other operating income, net. Accounting policies Wages, salaries, social security contributions, annual leave and sick leave, bonuses and non-monetary benefits are recognised in the year in which the associated services are rendered by employees of Novo Nordisk. Where Novo Nordisk provides long-term employee benefits, the costs are accrued to match the rendering of the services by the employees concerned. • Contractual research and development obligations to be paid in the future are disclosed separately as commitments in note 5.2. Employee costs DKK million Research and development costs by business segment (note 2.2) DKK million 2019 2018 Diabetes and Obesity care Biopharm Total Research and development costs DKK million Employee costs (note 2.4) Amortisation and impairment losses, intangible assets (note 3.1) Depreciation and impairment losses, property, plant and equipment (note 3.2) Other research and development costs Total research and development costs As percentage of net sales 12,128 2,092 14,220 2019 5,968 522 783 2017 11,358 2,656 12,222 2,583 14,805 14,014 2018 6,288 769 468 2017 5,848 211 525 6,947 7,280 7,430 14,220 11.7% 14,805 14,014 13.2% 12.5% Wages and salaries Share-based payment costs (note 5.1) Pensions – defined contribution plans Pensions – defined benefit plans (note 3.6) Other social security contributions Other employee costs 2019 25,335 363 1,910 151 1,963 2,203 2018 2017 25,259 414 1,791 73 1,901 2,087 23,869 292 1,800 165 1,910 2,102 Total employee costs for the year 31,925 31,525 30,138 Employee costs capitalised as intangible assets and property, plant and equipment Change in employee costs capital- ised as inventories Total employee costs in the income statement Included in the income statement: Cost of goods sold Sales and distribution costs Research and development costs Administrative costs Other operating income, net Total employee costs in the income statement (1,314) (1,500) (1,435) (139) (105) (91) 30,472 29,920 28,612 8,134 13,463 5,968 2,679 228 8,164 12,214 6,288 2,755 499 7,854 11,994 5,848 2,505 411 30,472 29,920 28,612 Average number of full-time employees Year-end number of full-time employees Employees (total) 42,218 42,881 41,665 42,703 43,258 42,672 43,202 42,076 42,682 Remuneration to Executive Management and Board of Directors DKK million 2019 2018 Salary and short-term incentive Pension Benefits Long-term incentive3 Severance payments Executive Management in total1,2 Fee to Board of Directors2 Total 120 26 14 40 — 200 19 219 102 22 4 22 28 178 17 195 2017 74 18 6 7 — 105 16 121 1. Jesper Brandgaard retired from Novo Nordisk in April 2019. Until April 2020 Jesper Brandgaard will continue to provide certain services for Novo Nordisk. Remuneration of Jesper Brandgaard from January to April 2019 is included in the above table. A severance payment of DKK 27.7 million is included in the 2018 amounts. 2. Total remuneration for registered members of Executive Management amounts to DKK 135 million (DKK 142 million in 2018 and DKK 74 million in 2017). All members of the Board of Directors are registered. 3. Please refer to note 5.1 for further information. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements53 2.5 Other operating income, net Accounting policies Other operating income, net, comprises licence income and income of a secondary nature in relation to the main activities of Novo Nordisk. Licence income from royalties on future net sales is recognised as the underlying customers' sale occurs and from sales milestones once the contingent sale milestone is achieved in accordance with the terms of the relevant agreement. Income from the transfer of the right to use intellectual property may contain development or regulatory milestones (variable consideration) on which the income is recognised when the significant uncertainties in achieving the milestones are resolved, due to the significant uncertainties inherent in the development of pharmaceutical products. Operating profit from the wholly owned subsidiary NNE A/S, not related to Novo Nordisk’s main activities, is recognised as other operating income. Other operating income also includes income from sale of intellectual property rights. 2.6 Income taxes and deferred income taxes Income taxes Accounting policies The tax expense for the period comprises current and deferred tax as well as interest on tax cases ongoing or settled during the year. It also includes adjust- ments to previous years and changes in provisions for uncertain tax positions. Tax is recognised in the income statement except to the extent that it relates to items recognised in equity or other comprehensive income. Provisions for ongoing tax disputes are included as part of deferred tax assets, tax receivables and tax payables. Management judgement regarding recognition of deferred income tax assets and provisions for uncertain tax positions Novo Nordisk is subject to income taxes around the world. Significant judgement and estimates are required in determining the worldwide accrual for income taxes, deferred income tax assets and liabilities and provisions for uncertain tax positions. Novo Nordisk recognises deferred income tax assets if it is probable that sufficient taxable income will be available in the future, against which the temporary differ- ences and unused tax losses can be utilised. Management has considered future taxable income and applied its judgement in assessing whether deferred income tax assets should be recognised. In the course of conducting business globally, tax and transfer pricing disputes with tax authorities may occur. Management judgement is applied to assess the possible outcome of such disputes. The 'most probable outcome' method is applied when making provisions for uncertain tax positions, and Novo Nordisk considers the provisions made to be adequate. However, the actual obligation may deviate and depends on the result of litigation and settlements with the relevant tax authorities. Swiss tax reform In 2019, a tax reform was passed in Switzerland. The tax reform has a minor positive impact on the effective tax rate in 2019, driven by a non-recurring increase to deferred tax assets. Income taxes expensed DKK million Current tax on profit for the year Deferred tax on profit for the year Tax on profit for the year Current tax adjustments recognised for prior years Deferred tax adjustments recognised for prior years Income taxes in the income statement Tax on other comprehensive income for the year, (income)/ expense 2019 11,275 (1,559) 9,716 2018 2017 10,469 (1,007) 10,562 182 9,462 10,744 (191) (522) (425) 77 47 231 9,602 8,987 10,550 231 (755) 1,041 DKK million 2019 2018 2017 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-taxable income less non-tax-deductible expenses (net) Others, including adjustment of prior years Effective tax rate 22.0% 22.0% 22.0% (2.1%) (1.9%) 0.0% 0.1% (0.2%) 0.1% (0.2%) 19.8% (1.0%) (0.4%) 18.9% 21.7% The impact of the deviation in foreign subsidiaries’ tax rates compared to the Danish tax rate is mainly driven by Swiss business activities. Income taxes paid DKK million Income taxes paid in Denmark for current year Income taxes paid outside Denmark for current year Income taxes paid/repayments relating to prior years 2019 2018 2017 7,774 2,258 904 6,640 6,798 2,376 2,639 598 (336) Total income taxes paid 10,936 9,614 9,101 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements54 2.6 Income taxes and deferred income taxes (continued) Deferred income taxes Accounting policies Deferred income taxes arise from temporary differences between the accounting and tax values of the individual consolidated companies and from realisable tax loss carry-forwards. The tax value of tax loss carry-forwards is included in deferred tax assets to the extent that these are expected to be utilised in future taxable income. The deferred income taxes are measured according to current tax rules and at the tax rates assumed in the year in which the assets are expected to be utilised. In general, the Danish tax rules related to dividends from group companies provide exemption from tax for most repatriated profits. A provision for with- holding tax is only recognised if a concrete distribution of dividends is planned. The unrecognised potential withholding tax amounts to DKK 315 million for 2019 (DKK 367 million in 2018). The value of future tax deductions in relation to share programmes is recognised as deferred tax, until the shares are paid out to the employees. Any estimated excess tax deduction compared to the costs realised in the income statement is charged to equity. Development in deferred income tax assets and liabilities DKK million 2019 Net deferred tax asset/(liability) at 1 January Change in accounting policy, leases Income/(charge) to the income statement Income/(charge) to other comprehensive income Income/(charge) to equity Disposal of subsidiaries Effect of exchange rate adjustment Net deferred tax asset/(liability) at 31 December Classified as follows: Deferred tax asset at 31 December Deferred tax liability at 31 December 2018 Net deferred tax asset/(liability) at 1 January Income/(charge) to the income statement Income/(charge) to other comprehensive income Income/(charge) to equity Effect of exchange rate adjustment Net deferred tax asset/(liability) at 31 December Classified as follows: Deferred tax asset at 31 December Deferred tax liability at 31 December Property, plant and equipment Intangible assets Inventories Liabilities Other (703) (865) (5) — — — (18) (1,591) 769 (2,360) (868) 199 — — (34) (703) 694 (1,397) (564) — (155) — — — 1 (718) 58 (776) (500) (67) — — 3 (564) 52 (616) 973 — 820 18 — — — 1,811 3,428 (1,617) 833 177 (37) — — 973 2,490 (1,517) 2,402 865 133 47 — (18) 23 3,452 3,580 (128) 1,658 763 (22) — 3 2,402 2,403 (1) Offset within countries — 667 — 689 (296) 18 — 9 1,087 — 1,843 (756) (5,557) 5,557 (28) (112) 814 (15) 8 667 — — 833 (166) (3,579) 3,579 Total 2,775 — 1,482 (231) 18 (18) 15 4,041 4,121 (80) 1,095 960 755 (15) (20) 2,775 2,893 (118) The total tax value of unrecognised tax loss carry-forwards amounts to DKK 144 million in 2019 (DKK 90 million in 2018). Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial StatementsSection 3 Operating assets and liabilities 55 Additions Additions to intangible assets amount to DKK 2,179 million. The additions related to patents and licences amount to DKK 1,599 million (DKK 1,403 million in 2018) within Diabetes and Obesity care and DKK 359 million (DKK 1,165 million in 2018) within Biopharm. Please refer to note 5.2 Commitment for an overview of total contractual commitments. In 2018 and 2019 Novo Nordisk both acquired intellectual property and entered into major patent and licence agreements, as summarised below. Upfront fees and acquisition costs have been capitalised and subsequent milestone payments payable on achievement of a contingent event will be capitalised on the contin- gent event being probable of being achieved. 2019 additions Dicerna Novo Nordisk has entered into a collaboration and license agreement providing development and commercialisation rights to novel therapies for the treatment of liver-related cardio-metabolic diseases using Dicerna’s proprietary GalXC™ RNAi platform technology. The addition relates to the Diabetes and Obesity care segment. Priority review voucher During 2019 Novo Nordisk acquired a priority review voucher intended for use in the Diabetes and Obesity care segment. Esperoct™ milestones Novo Nordisk has capitalised two milestone payments to the business partner following EU and FDA approval of Esperoct™. The additions relate to the Biopharm segment. 2018 additions Macrilen™ Novo Nordisk has acquired the US and Canadian rights to Macrilen™ (macimo- relin), the first and only FDA-approved oral growth hormone receptor indicated for the diagnosis of Adult Growth Hormone Deficiency, a rare endocrine disorder. The acquisition relates to the Biopharm segment. Priority review voucher During 2018 Novo Nordisk acquired a priority review voucher which has been fully amortised on notification and commitment to the FDA in December 2018 of the intent to use the Priority Review Voucher for the oral semaglutide New Drug Application (NDA) filing. The acquisition relates to the Diabetes and Obesity care segment. Ziylo Ltd Novo Nordisk has acquired full rights to Ziylo's glucose binding molecule platform to develop glucose responsive insulins. The acquisition relates to the Diabetes and Obesity care segment. 3.1 Intangible assets Accounting policies Patents and licences, including patents and licences acquired for research and development projects, are carried at historical cost less accumulated amortisation and any impairment loss. Amortisation is based on the straight-line method over the estimated useful life. This means the legal duration or the economic useful life depending on which is shorter, and not exceeding 15 years. The amortisation of patents and licences begins after regulatory approval has been obtained. Internal development of software for internal use is recognised as intangible assets if the recognition criteria are met, for example a significant business system where the expenditure leads to the creation of a durable asset. Amortisation is based on the straight-line method over the estimated useful life of 3-15 years. The amortisa- tion begins when the asset is in the location and condition necessary for it to be capable of operating in the manner intended by Management. Research and development projects Internal and subcontracted research costs are charged in full to the consolidated income statement in the period in which they are incurred. Consistent with industry practice, internal development costs are also expensed until regulatory approval is obtained or is probable; please refer to note 2.3. Payments to third parties under collaboration and license agreements are assessed for the substance of their nature. Payments which represent subcontracted research and development are expensed as the services are received. Payments which represent rights to the transfer of intellectual property, developed at risk by the third party, are capitalised. For acquired research and development projects, patents and licences the likeli- hood of obtaining future commercial sales is reflected in the cost of the asset, and thus the probability recognition criteria is always considered to be satisfied. As the cost of acquired research and development projects can often be measured reliably, these projects fulfil the capitalisation criteria as intangible assets on acqui- sition. Subsequent milestone payments payable on achievement of a contingent event (e.g. commencement of phase 3 trials) are accrued and capitalised into the cost of the intangible asset when the achievement of the event is probable. However, further internal development costs subsequent to acquisition are treated in the same way as other internal development costs. Key accounting estimates of impairment of assets Intangible assets with an indefinite useful life and intangible assets not yet avail- able for use are not subject to amortisation. They are tested annually for impair- ment, irrespective of whether there is any indication that they may be impaired. Assets that are subject to amortisation are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. Factors considered material that could trigger an impairment test include the following: • Development of a competing drug • Changes in the legal framework covering patents, rights and licences • Advances in medicine and/or technology that affect the medical treatments • Lower-than-predicted sales • Adverse impact on reputation and/or brand names • Changes in the economic lives of similar assets • Relationship to other intangible assets or property, plant and equipment • Changes or anticipated changes in participation rates or reimbursement policies. If the carrying amount of intangible assets exceeds the recoverable amount based on the existence of one or more of the above indicators of impairment, any impairment is measured based on discounted projected cash flows. Impairments are reviewed at each reporting date for possible reversal. Intangible assets DKK million Patents and licences Software Total intangible assets 2019 4,627 1,208 5,835 2018 3,858 1,287 5,145 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements56 Amortisation and impairment losses DKK million 2019 2018 Cost of goods sold Sales and distribution costs Research and development costs Administrative costs Other operating income, net Total amortisation and impairment losses Total amortisation Total impairment losses 916 24 522 3 4 1,469 487 982 208 15 769 2 6 1,000 1,000 — Capital expenditure in the reported period was primarily related to investments in facility upgrades and new production facilities for active pharmaceutical ingredi- ents for diabetes, mainly the facility in Clayton, US. The facility in Clayton will also be used for tableting and packing of oral products. Capital expenditure also related to new diabetes filling capacity in Hillerød. The facility will serve as a backup production facility for the US market and act as a launch site for new injectable diabetes products. Finally, capital expenditure related to expansion of the facility in Chartres, France. The investment will establish FlexTouch® assembly and packaging capacity at the Chartres site. Depreciation and impairment losses DKK million Cost of goods sold Sales and distribution costs Research and development costs Administrative costs Other operating income, net Total depreciation and impairment losses 2019 2,656 354 783 376 23 4,192 2018 2,312 69 468 70 6 2,925 3.1 Intangible assets (continued) Amortisation and impairment losses In 2019, an impairment loss of DKK 982 million was recognised (no impairment losses were recognised in 2018), substantially all of which related to patents and licences. DKK 282 million of the impairment was related to the Diabetes and Obesity care segment and DKK 700 million of the impairment was related to Biopharm. Of the total impairment loss, DKK 529 million was recognised in cost of goods sold and DKK 450 million in research and development costs. The impairment was a result of Management’s review of projected future cash flows from marketable products and expectations related to patents and licences not yet in use. The impairment losses related to marketable products were based on fair value less cost of disposal calculations. The projected future cash flows were prepared based on Management’s expectations for market access, market share and devel- opment in net sales prices. Management has used a post-tax discount rate of 7%. The inherent risk and uncertainty related to cash flows were adjusted for in the expected future cash flows. Intangible assets not yet in use amount to DKK 3,380 million (DKK 2,612 million in 2018), primarily patents and licences in relation to research and development projects. Impairment tests in 2019 and 2018 of patents and licences not yet in use are based on Management’s projections and anticipated net present value of estimated future cash flows from marketable products. Terminal values used are based on the expected life of products, forecasted life cycle and cash flow over that period, and the useful life of the underlying assets. 3.2 Property, plant and equipment Novo Nordisk´s approach to managing operating assets is to retain assets for research, development and production activities under the company’s own control, and to lease non-core assets related to e.g. administration and distribution. Management believes this is a significant factor in maintaining the quality of the company´s products. Accounting policies Property, plant and equipment is measured at historical cost less accumulated depreciation and any impairment loss. The cost of self-constructed assets includes costs directly and indirectly attributable to the construction of the assets. Any subsequent cost is included in the asset’s carrying amount or recognised as a separate asset only when it is probable that future economic benefits associated with the item will flow to Novo Nordisk and the cost of the item can be measured reliably. Depreciation is based on the straight-line method over the estimated useful lives of the assets: • Buildings: 12-50 years • Plant and machinery: 5-20 years • Other equipment: 3-10 years • Land: not depreciated. The depreciation commences when the asset is available for use, i.e. when it is in the location and condition necessary for it to be capable of operating in the manner intended by Management. The assets’ residual values and useful lives are reviewed and adjusted, if appro- priate, at the end of each reporting period. If an asset’s carrying amount is higher than its estimated recoverable amount, it is written down to the recoverable amount. Plant and equipment with no alternative use developed as part of a research and development project are expensed. However, plant and equipment with an alter- native use or used for general research and development purposes are capitalised and depreciated over the estimated useful life as research and development costs. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements 3.2 Property, plant and equipment (continued) Property, plant and equipment DKK million 2019 Cost at the beginning of the year Change in accounting policy, leases Additions during the year Disposals during the year Transfer from assets under construction Effect of exchange rate adjustment 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 and impairment losses reversed on disposals during the year Effect of exchange rate adjustment Depreciation and impairment losses at the end of the year Carrying amount at the end of the year 2018 Cost at the beginning of the year Additions during the year Disposals during the year Transfer from assets under construction Effect of exchange rate adjustment 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 and impairment losses reversed on disposals during the year Effect of exchange rate adjustment Depreciation and impairment losses at the end of the year Carrying amount at the end of the year 57 Total 72,438 3,778 8,983 (1,229) — 450 16,846 — 7,580 (74) (4,190) 189 20,351 84,420 — — 74 (74) — — 30,547 3,971 221 (967) 97 33,869 20,351 50,551 14,361 8,775 — (6,410) 120 64,661 9,537 (1,867) — 107 16,846 72,438 — — — — — — 29,414 2,809 116 (1,744) (48) 30,547 16,846 41,891 Land and buildings Plant and machinery Other equipment Assets under construction 25,401 3,291 555 (407) 1,277 143 25,412 — 350 (504) 2,248 88 30,260 27,594 9,770 1,818 57 (160) 43 17,871 1,410 70 (504) 41 11,528 18,888 18,732 8,706 22,032 222 (267) 3,448 (34) 23,799 365 (1,422) 2,667 3 25,401 25,412 8,934 1,047 49 (235) (25) 17,808 1,377 63 (1,346) (31) 9,770 17,871 15,631 7,541 4,779 487 498 (244) 665 30 6,215 2,906 743 20 (229) 13 3,453 2,762 4,469 175 (178) 295 18 4,779 2,672 385 4 (163) 8 2,906 1,873 3.3 Leases Accounting policies Novo Nordisk mainly leases office buildings, warehouses, laboratories and vehicles. For contracts which are, or contain, a lease, the Group recognises a right-of-use asset and a lease liability. The right-of-use asset is initially measured at cost, being the initial amount of the lease liability. The right-of-use asset is subsequently depreciated using the straight-line method over the lease term. The right-of-use asset is periodically adjusted for certain remeasurements of the lease liability and reduced by any impairment losses. The lease term determined by the Group is the non-cancellable period of a lease, together with extension/termination option if these are reasonably certain to be exercised. When determining the term, Management considers multiple factors that create economic incentives to exercise an option to extend the lease or not to terminate the lease, including termination penalties, potential relocation costs and whether significant leasehold improvements have been capitalised on the lease, with a remaining useful life which exceeds the fixed minimum duration of the lease. For contracts with a rolling term (evergreen leases), the Group estimates the leasing period to be equal to the termination period if no probable scenario exists for estimating the leasing period. The lease liability is initially measured at the present value of the lease payments outstanding at the commencement date, discounted using the incremental borrowing rate. Lease payments consist of the following payments: • fixed payments from commencement date • certain variable payments • residual value guarantees or the exercise price of a purchase option • termination penalties The lease liability is measured using the effective interest method. The lease liability is remeasured when there is a change in future lease payments, typically due to a change in index or rate (e.g. inflation) on property leases, or if there is a reassessment of whether an extension or termination option will be exercised. A corresponding adjustment is made to the right-of-use asset, or in the income statement when the right-of-use asset has been fully depreciated. The right-of-use asset is presented in property, plant and equipment and the lease liability in borrowings. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements3.3 Leases (continued) New lease contracts with a lease term of 12 months or less and lease of low value assets are not recognised on the balance sheet. These are expensed on a straight- line basis over the lease term or another systematic basis. Lease of low value assets include personal computers, telephones and small items of office equipment. Variable lease payments may depend on an index, a rate or other elements. Variable lease payments that depend on an index or a rate are included in the initial measurement of the lease liability using the index/rate at the lease commencement date. Variable lease payments not based on an index or a rate are recognised as an expense in the income statement as incurred. Amounts recognised in the income statement DKK million Depreciation Interest on lease liabilities Variable lease expenses Short-term leases Lease of low value assets Total amounts recognised in the income statement Residual value guarantees that are expected to be paid are included in the initial measurement of the lease liability. Please refer to note 4.2. The lease costs for 2018 were DKK 1,299 million. As of 31 December 2019, the lease liability excludes DKK 2,760 million (undis- counted) of potential lease payments related to lease term extension rights on properties, which were not considered reasonably certain to be exercised. Amounts recognised in the cash flow statement DKK million 58 2019 852 108 113 201 63 1,337 Property, plant and equipment presented in the balance sheet includes the following right-of-use assets. Right-of-use assets in the balance sheet Total cash outflow for leases 1,295 Please refer to note 4.2 for a maturity analysis of lease payments. Land and buildings Other equipment 3,291 333 (564) (31) 3,029 487 307 (288) (3) 503 Total 3,778 640 (852) (34) 3,532 DKK million 2019 Balance at 1 January Additions during the year Depreciation for the year Other movements Balance at 31 December 3.4 Inventories Accounting policies Inventories are stated at cost or net realisable value, whichever is lower. Cost is determined using the first-in, first-out method. Cost comprises direct production costs such as raw materials, consumables and labour as well as indirect production costs. Production costs for work in progress and finished goods include indirect production costs such as employee costs, depreciation, maintenance, etc. If the expected sales price less completion 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. Inventory manufactured prior to regulatory approval (prelaunch inventory) is capi- talised but immediately provided for, until there is a high probability of regulatory approval for the product. A write-down is made against inventory, and the cost is recognised in the income statement as research and development costs. Once there is a high probability of regulatory approval being obtained, the write-down is reversed, up to no more than the original cost. In March 2019, Novo Nordisk filed oral semaglutide for US regulatory approval of glycaemic control. Subsequent to filing, write-downs on prelaunch inventory was reversed with a net positive income statement effect of DKK 510 million on research and development costs. Regulatory approval was obtained in September 2019. Key accounting estimate of indirect production costs capitalised and inventory write-downs Indirect production costs account for approximately 50% of the net inventory value, reflecting a lengthy production process compared with low direct raw material costs. The production of both Diabetes and Obesity care and Biopharm products is highly complex from fermentation to purification and formulation, including quality control of all production processes. Furthermore, the process is very sensitive to manufacturing conditions. These factors all influence the parameters for capitalisation of indirect production costs at Novo Nordisk and the full cost of the products. Indirect production costs are measured using a standard cost method. This is reviewed regularly to ensure relevant measures of capacity utilisation, production lead time, cost base and other relevant factors, hence inventory is valued at actual cost. When calculating total inventory, Management must make judgements about cost of production, standard cost variances and idle capacity in estimating indirect production costs for capitalisation. Changes in the parameters for calculation of indirect production costs could have an impact on the gross margin and the overall valuation of inventories. Inventories DKK million Raw materials Work in progress Finished goods Total inventories (gross) Write-downs at year-end Total inventories (net) Indirect production costs included in work in progress and finished goods Share of total inventories (net) Movements in inventory write-downs Write-downs at the beginning of the year Write-downs during the year Utilisation of write-downs Reversal of write-downs Write-downs at the end of the year 2019 2,842 11,375 4,850 19,067 (1,426) 17,641 9,216 52% 1,959 414 (68) (879) 1,426 2018 2,464 11,753 4,078 18,295 (1,959) 16,336 8,533 52% 2,219 509 (409) (360) 1,959 All write-downs in both 2018 and 2019 relate to fully impaired inventory. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements59 Gross carrying amount Loss allowance Net carrying amount 24,359 1,204 261 96 79 397 (763) (127) (69) (49) (79) (397) 23,596 1,077 192 47 — — 3.5 Trade receivables Accounting policies Trade receivables are initially recognised at fair value and subsequently measured at amortised cost using the effective interest method, less allowance for doubtful trade receivables. Trade receivables DKK million 2019 Before being sold, trade receivables in factoring portfolios are measured at fair value with changes recognised in other comprehensive income. The allowance for doubtful receivables is deducted from the carrying amount of Trade receivables, and the amount of the loss is recognised in the income statement under Sales and distribution costs. Subsequent recoveries of amounts previously written off are credited against sales and distribution costs. Novo Nordisk’s customer base comprises government agencies, wholesalers, retail pharmacies and other customers. Management makes allowance for doubtful trade receivables based on the simplified approach to provide for expected credit losses, which permits the use of the lifetime expected loss provision for all trade receivables. The allowance is an estimate based on shared credit risk characteristics and the days past due. Generally, invoices are due for payment within 90 days of shipment of goods. Loss allowance is calculated using an ageing factor, geographical risk and specific customer knowledge. The allowance is based on a provision matrix on days past due and a forward looking element relating mainly to incorporation of the Dun & Bradstreet country risk rating and an individual assessment. Please refer to note 4.3 for a general description of credit risk. Not yet due 1-90 days 91-180 days 181-270 days 271-360 days More than 360 days past due Trade receivables 26,396 (1,484) 24,912 DKK million 2018 Not yet due 1-90 days 91-180 days 181-270 days 271-360 days More than 360 days past due Gross carrying amount Loss allowance Net carrying amount 22,359 1,055 235 60 76 371 (692) (111) (79) (41) (76) (371) 21,667 944 156 19 — — Trade receivables 24,156 (1,370) 22,786 Many of the countries within Region AAMEO have significant sales and low credit ratings. As such, this region has a relatively high impact on the allowance for doubtful trade receivables. Movements in allowance for doubtful trade receivables Novo Nordisk closely monitors the current economic conditions of countries impacted by currency fluctuations, high inflation and an unstable political climate. These indicators as well as payment history are taken into account in the valuation of trade receivables. Please refer to note 2.2 for a geographical split of trade receivables and allowance for doubtful trade receivables, and notes 4.3 and 4.8 for the trade receivable programmes. Carrying amount at the beginning of the year Reversal of allowance on realised losses Net movement recognised in income statement Effect of exchange rate adjustment Allowance at the end of the year 2019 1,370 (45) 158 1 1,484 2018 1,294 (25) 164 (63) 1,370 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements 60 3.6 Retirement benefit obligations Accounting policies Defined contribution plans Novo Nordisk operates a number of defined contribution plans throughout the world. These plans are externally funded in entities that are legally separate from the Group. Novo Nordisk’s contributions to the defined contribution plans are charged to the income statement in the year to which they relate. Net retirement benefit obligations DKK million Retirement benefit obligations Fair value of plan assets 2019 2018 2,508 1,174 2,488 1,232 Defined benefit plans In a few countries, Novo Nordisk operates defined benefit plans, primarily located in the US, Germany, Switzerland and Japan. In Germany and Switzerland, the defined benefit plans are partly reimbursed by international insurance companies. The risk related to the plan assets in these countries is therefore limited to coun- terparty risk against these insurance companies. Recognition of 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 valua- tion dates and is based on actuarial assumptions primarily regarding discount rates used in determining the present value of benefits and projected rates of remuneration growth. Discount rates are based on the market yields of high-rated corporate bonds in the country concerned. Actuarial gains and losses arising from experience adjustments and changes in actuarial assumptions are charged or credited to other comprehensive income in the period in which they arise. Past service costs are recognised immediately in the income statement. Pension plan assets are only recognised to the extent that Novo Nordisk is able to derive future economic benefits such as refunds from the plan or reductions of future contributions. Costs recognised for retirement benefits are included in cost of goods sold, sales and distribution costs, research and development costs, and administrative costs. The total cost recognised for the year amounts to DKK 151 million (DKK 73 million in 2018). The net obligation recognised in the balance sheet is reported as non-current liabilities. Net retirement benefit obligations at the end of the year 1,334 1,256 The present value of partly funded retirement benefit obligations amounts to DKK 1,845 million (DKK 1,841 million in 2018). The present value of unfunded retire- ment benefit obligations amounts to DKK 663 million (DKK 647 million in 2018). Net remeasurement is a loss of DKK 187 million (gain of DKK 87 million in 2018), primarily related to changes in financial assumptions (discount rate), and is included in other comprehensive income. Please refer to note 5.2 for a maturity analysis of the net retirement benefit obliga- tion. Novo Nordisk does not expect the contributions over the next five years to differ significantly from current contributions. Actuarial valuations are performed annually for all major defined benefit plans. Assumptions regarding future mortality are based on actuarial advice in accordance with published statistics and experience in each country. Other assumptions such as medical cost trend rate and inflation are also considered in the calculation. Significant actuarial assumptions for the determination of the retirement benefit obligation (not considering plan assets) are discount rate and expected future remuneration increases. The sensitivity analysis below has been determined based on reasonably likely changes in the assumptions occurring at the end of the period. The sensitivities below consider the single change shown with the other assumptions assumed to be unchanged. The table shows the NPV impact of net retirement liabilities. Key assumptions used for valuation and sensitivity analysis DKK million 2019 Discount rate (decrease)/increase Future remuneration growth (decrease)/increase 2018 Discount rate (decrease)/increase Future remuneration growth (decrease)/increase Key assumptions 1 %-point increase 1 %-point decrease 1.3% 2.4% 2.1% 2.5% (366) 105 (369) 99 465 (94) 458 (89) Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements61 3.7 Provisions and contingent liabilities Accounting policies Provisions for sales rebates and discounts granted to government agencies, wholesalers, retail pharmacies, Managed Care and other customers are recorded at the time the related revenues are recorded or when the incentives are offered. Provisions are calculated based on historical experience and the specific terms in the individual agreements. Unsettled rebates are recognised as provisions when the timing or amount is uncertain. Where absolute amounts are known, the rebates are recognised as other liabilities. Please refer to note 2.1 for further information on sales rebates and provisions. Provisions for legal disputes are recognised where a legal or constructive obligation has been incurred as a result of past events and it is probable that there will be an outflow of resources that can be reliably estimated. In this case, Novo Nordisk arrives at an estimate based on an evaluation of the most likely outcome. Disputes for which no reliable estimate can be made are disclosed as contingent liabilities. Provisions are measured at the present value of the anticipated expenditure for settlement. This is calculated using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the obligation. The increase in the provision for interest is recognised as a financial expense. Provisions DKK million At the beginning of the year Additional provisions, including increases to existing provisions Amount used during the year Adjustments, including unused amounts reversed during the year Effect of exchange rate adjustment At the end of the year Non-current liabilities2 Current liabilities Novo Nordisk issues credit notes for expired goods as a part of normal business. Where there is historical experience or a reasonably accurate estimate of expected future returns can otherwise be made, a provision for estimated product returns is recorded. The provision is measured at gross sales value. Key accounting estimate regarding ongoing legal disputes, litigation and investigations Provisions for legal disputes consist of various types of provision linked to ongoing legal disputes. Management makes estimates regarding provisions and contingen- cies, including the probability of pending and potential future litigation outcomes. These are by nature dependent on inherently uncertain future events. When determining likely outcomes of litigation, etc. Management considers the input of external counsels on each case, as well as known outcomes in case law. Although Management believes that the total provisions for legal proceedings are adequate based on currently available information, there can be no assurance that there will not be any changes in facts or matters, or that any future lawsuits, claims, proceedings or investigations will not be material. Provisions for sales rebates Provisions for legal disputes Provisions for product returns Other provisions1 25,760 102,782 (98,655) 381 610 30,878 551 30,327 1,860 650 (4) (156) 25 2,375 2,375 — 869 679 (424) (48) 6 1,082 300 782 1,064 510 (161) (29) 14 1,398 1,387 11 2019 total 29,553 104,621 (99,244) 148 655 35,733 4,613 31,120 2018 total 24,057 83,337 (79,243) 314 1,088 29,553 3,392 26,161 1. Other provisions consists of various types of provision, including obligations in relation to employee benefits such as jubilee benefits, company-owned life insurance, etc. 2. For non-current liabilities, provision for sales rebates is expected to be settled after one year, provisions for product returns will be utilised in 2021 and 2022. In the case of provisions for legal disputes, the timing of settlement cannot be determined. Contingent liabilities Novo Nordisk is currently involved in pending litigations, claims and investiga- tions arising out of the normal conduct of its business. While provisions that Management deems to be reasonable and appropriate have been made for prob- able losses, there are uncertainties connected with these estimates. Novo Nordisk does not expect the pending litigations, claims and investigations, individually and in the aggregate, to have a material impact on Novo Nordisk’s financial position, operating profit or cash flow in addition to the amounts accrued as provision for legal disputes. Pending litigation against Novo Nordisk Novo Nordisk, along with the majority of incretin-based product manufacturers in the United States, is a defendant in product liability lawsuits related to use of incretin-based medications. As of 3 February 2020, 332 plaintiffs have named Novo Nordisk in product liability lawsuits, predominantly claiming damages for pancreatic cancer that allegedly developed as a result of using Victoza® and other GLP-1/DPP-IV incretin-based products. 209 of the Novo Nordisk plaintiffs have also named other defendants in their lawsuits. Most Novo Nordisk plaintiffs have filed suit in California federal and state courts. Novo Nordisk does not currently have any individual trials scheduled in 2020. Novo Nordisk does not expect the pending claims to have a material impact on its financial position, operating profit or cash flow. Since January 2017, several class action lawsuits have been filed against Novo Nordisk, former CEO Lars Rebien Sørensen, former CFO Jesper Brandgaard and former President of Novo Nordisk Inc. Jakob Riis in the United States District Court for the District of New Jersey on behalf of all purchasers of Novo Nordisk American Depositary Receipts between February 2015 and February 2017. All lawsuits have been consolidated into one case. The lawsuit alleges that Novo Nordisk artificially inflated its financial results, failed to disclose pricing pressure and rising rebate payments to PBMs, and made other materially misleading state- ments to potential investors. Novo Nordisk does not expect the litigation to have a material impact on Novo Nordisk’s financial position, operating profit or cash flow. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements62 • Washington Attorney General’s Office CID (2017), relating to, among other things, pricing and trade practices for insulin products, including Levemir®, NovoLog®, and Novolin®, from 1 January 2005 through the present date. • New Mexico Attorney General’s Office CID (2017), relating to, among other things, trade practice and pricing of insulin products, namely NovoLog® and Novolin® from 1 January 2012 through the present date. • Texas Attorney General’s Office CID (2019), relating to, among other things, marketing and promotional practices for Ozempic®. • New York State Attorney General’s Office Subpoena (2019), relating to, among other things, pricing and trade practices for insulin products, from 1 July 2013 through the present. • Colorado Attorney General’s Office CID (2019), relating to, among other things, pricing and trade practices for insulin products, for the period from 1 January 2010 to present. In all matters Novo Nordisk is cooperating with the authority in question. Novo Nordisk does not expect the above investigations to have a material impact on Novo Nordisk’s financial position, operating profit or cash flow. Novo Nordisk is one of several pharmaceutical companies that received requests for information involving pricing practices for its diabetes products from several committees of the Unites States House of Representatives and/or United States Senate. Novo Nordisk is working with the staff of the various committees to respond to their questions. Novo Nordisk does not expect the inquiries to have a material impact on Novo Nordisk’s financial position, operating profit or cash flow. Other contingent liabilities In addition to the above, the Novo Nordisk Group is engaged in certain litigation proceedings and various ongoing audits and investigations. In the opinion of Management, neither settlement or continuation of such proceedings, nor such pending audits and investigations, are expected to have a material effect on Novo Nordisk’s financial position, operating profit or cash flow. 3.7 Provisions and contingent liabilities (continued) In August 2019, a securities lawsuit was filed against Novo Nordisk in Denmark by a number of institutional shareholders. The claim is for a total amount of DKK 11.6 billion based on trading and holding of shares in Novo Nordisk during the period between February 2015 and February 2017. The lawsuit alleges that Novo Nordisk made misleading statements and did not make appropriate disclosures regarding its sales of insulin products in the US. It appears to contain broadly similar allegations to those of the previously disclosed securities class action lawsuit filed in the US in 2017 on behalf of all purchasers of Novo Nordisk American Depository Receipts. Novo Nordisk does not expect the lawsuit to have a material impact on Novo Nordisk’s financial position, operating profit or cash flow. Since January 2017, thirteen lawsuits, including several putative class actions, have been filed in various federal and state courts against Novo Nordisk Inc., Sanofi, Eli Lilly, and others relating to the pricing of diabetes medicines. Six of these lawsuits were consolidated into one matter pending in the United States District Court for the District of New Jersey, yet one of these six lawsuits was later decon- solidated and voluntarily dismissed without prejudice. Additionally, two of the thirteen lawsuits were also voluntarily dismissed in 2019 and 2020. Accordingly, six lawsuits remain pending against Novo Nordisk in various jurisdictions. Three lawsuits are pending in the same New Jersey federal court as the consolidated matter referenced above, while two other lawsuits are pending in other jurisdic- tions (Kentucky state court and Texas federal court). All pending matters allege that the manufacturers and Pharmacy Benefit Managers (PBMs) colluded to artificially inflate list prices paid by consumers for diabetes products, while offering reduced prices to PBMs through rebates used to secure formulary access. Novo Nordisk does not expect the lawsuits to have a material impact on Novo Nordisk’s financial position, operating profit or cash flow. Pending claims against Novo Nordisk and investigations involving Novo Nordisk Several authorities in the US have served Novo Nordisk with Civil Investigative Demands (CIDs) or subpoenas calling for the production of documents and infor- mation. Below is a list of ongoing matters: • United States Department of Justice CID (2016) and Washington State Attorney General’s Office CID (2014 and 2016) both relating to, among other things, the promotion and marketing of NovoSeven®, interactions with physicians and patients, and the use of haemophilia-related patient support programmes. 3.8 Other liabilities Other liabilities primarily comprises employee cost payables, payables related to non-current assets and sales rebates. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial StatementsSection 4 Capital structure and financial items 4.1 Share capital, distributions to shareholders and earnings per share Share capital DKK million Development in share capital: Share capital 2016 Cancelled in 2017 Cancelled in 2018 Share capital at the beginning of the year Cancelled in 2019 Share capital at the end of the year 63 A share capital B share capital Total share capital 107 — — 107 — 107 403 (10) (10) 383 (10) 373 510 (10) (10) 490 (10) 480 At the end of 2019, the share capital amounted to DKK 107 million in A share capital (equal to 537 million A shares of DKK 0.20) and DKK 373 million in B share capital (equal to 1,863 million B shares of DKK 0.20). Each A share carries 200 votes and each B share carries 20 votes.  Cash distribution to shareholders Novo Nordisk paid out an interim dividend of DKK 3.00 per share in August 2019. The net cash distribution to shareholders in the form of dividends and share repurchases amounts to DKK 34.7 billion, compared with a free cash flow of DKK 34.5 billion. This is in line with the guiding principle of paying out excess capital to investors after funding organic growth and potential acquisitions. DKK million Interim dividend for the year Dividend for prior year Share repurchases for the year Total 2019 7,100 12,309 15,334 34,743 2018 2017 7,238 11,810 15,567 7,396 11,448 16,845 34,615 35,689 The total dividend for 2019 amounts to DKK 19,651 million (DKK 8.35 per share). The 2019 final dividend of DKK 12,551 million (DKK 5.35 per share) is expected to be distributed pending approval at the Annual General Meeting. The interim dividend of DKK 7,100 million (DKK 3.00 per share) was paid in August 2019. The total dividend for 2018 was DKK 19,547 million (DKK 8.15 per share), of which the final dividend of DKK 12,309 million (DKK 5.15 per share) was paid in March 2019. No dividend is declared on treasury shares. According to Danish corporate law, reserves available for distribution as dividends are based on the financial statements of the parent company, Novo Nordisk A/S. Dividends are paid from distributable reserves. Share premium is a distributable reserve and any former share premium reserve has been fully distributed. As at 31 December 2019, distributable reserves total DKK 40,801 million (2018: DKK 38,816 million), corresponding to the parent company's retained earnings. Treasury shares Accounting policies Treasury shares are deducted from the share capital on cancellation at their nominal value of DKK 0.20 per share. Differences between this amount and the amount paid to acquire or received for disposing of treasury shares are deducted directly in Equity. Holding at the beginning of the year Cancellation of treasury shares Transfer regarding restricted stock units Purchase during the year Value adjustment Holding at the end of the year 2019 2018 Market value, DKK million As % of share capital before cancellation As % of share capital after cancellation Number of B shares of DKK 0.20 (million) Number of B shares of DKK 0.20 (million) 2.3% (2.0%) 16,610 (14,895) (762) 15,334 2,326 18,613 2.0% 56 (50) (3) 45 — 48 56 (50) (1) 51 — 56 Treasury shares are primarily acquired to reduce the company’s share capital. In addition, a limited part is used to finance Novo Nordisk’s long-term share-based incentive programme (restricted stock units) and restricted stock units to employees. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements64 4.1 Share capital, distributions to shareholders and earnings per share (continued) Novo Nordisk’s guiding principle is that any excess capital, after the funding of organic growth opportunities and potential acquisitions, should be returned to investors. Novo Nordisk’s dividend payouts are complemented by share repurchase programmes. The purchase of treasury shares during the year relates to the remaining part of the 2018 share repurchase programme, totalling DKK 1.2 billion and the DKK 15 billion Novo Nordisk B share repurchase programme for 2019, of which DKK 0.9 billion was outstanding at year-end. The programme ended on 3 February 2020. Transfer of treasury shares relates to the long-term share-based incentive programme and restricted stock units to employees. Earnings per share Accounting policies Earnings per share is presented as both basic and diluted earnings per share. Basic earnings per share is calculated as net profit divided by the average number of shares outstanding. Diluted earnings per share is calculated as net profit divided by the sum of average number of shares outstanding, including the dilutive effect of the outstanding share pool. Please refer to ‘Financial definitions’ for a description of calculation of the dilutive effect. DKK million Net profit for the year 2019 2018 2017 38,951 38,628 38,130 Average number of shares outstanding Dilutive effect of average outstanding share pool1 Average number of shares outstanding, including dilutive effect of outstanding share pool in 1,000 shares in 1,000 shares in 1,000 shares 2,374,299 4,359 2,378,658 2,419,603 4,814 2,424,417 2,473,218 4,875 2,478,093 Basic earnings per share Diluted earnings per share 1. For further information on the outstanding share pool, please refer to note 5.1. DKK DKK 16.41 16.38 15.96 15.93 15.42 15.39 4.2 Borrowings Contractual undiscounted cashflows DKK million 2019 Within 1 year 1-3 years 3-5 years More than 5 years Total contractual undiscounted cash flows at the end of the year Contractual discounted cash flows included in the balance sheet at the end of the year Non-current liabilities Current liabilities Leases Bank overdrafts1 847 1,424 734 1,140 4,145 3,824 3,009 815 659 — — — 659 659 — 659 Total 1,506 1,424 734 1,140 4,804 4,483 3,009 1,474 1. Bank overdrafts includes DKK 595 million classified as financing activities (2018: DKK 506 million) and DKK 64 million classified as cash and cash equivalents (2018: DKK 9 million). Reconciliation of liabilities arising from financing activities DKK million 2019 Lease liabilities Bank overdrafts Liabilities arising from financing activities Bank overdrafts Total borrowings Non-cash movements Beginning of the year Cash flows Additions Disposals Exchange rates End of the year Other 3,988 506 4,494 9 (822) 81 (741) 55 4,503 (686) 640 — 640 — 640 (57) — (57) — (57) 63 8 71 — 71 12 — 12 — 12 3,824 595 4,419 64 4,483 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements4.3 Financial risks Novo Nordisk has centralised management of the Group’s financial risks. The overall objectives and policies for the company’s financial risk management are outlined in an internal 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 permitted use of 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, and all positions are marked-to-market. Management has assessed the following key financial risks: Type Financial risk Foreign exchange risk Interest rate risk Liquidity risk Credit risk High Low Low Low Foreign exchange risk Foreign exchange risk is the most important financial risk for Novo Nordisk and can have a significant impact on the income statement, statement of comprehen- sive income, balance sheet and cash flow statement. The overall objective of foreign exchange risk management is to reduce the short- term negative impact of exchange rate fluctuations on earnings and cash flow, thereby contributing to the predictability of the financial results. The majority of Novo Nordisk’s sales are in USD, EUR, CNY, JPY, CAD and GBP. The foreign exchange risk is most significant in USD, CNY and JPY, while the EUR exchange rate risk is regarded as low because of Denmark’s fixed exchange rate policy towards EUR. Novo Nordisk hedges existing assets and liabilities in key currencies as well as future expected cash flows up to a maximum of 24 months forward. Hedge accounting is applied to match the impact of the hedged item and the hedging instrument in the consolidated income statement. Management has chosen to classify the result of hedging activities as part of financial items. During 2019, the hedging horizon varied between 6 and 13 months for USD, CNY, JPY, CAD and GBP. The currency hedging strategy balances risk reduction and cost of hedging by use of foreign exchange forwards and foreign exchange options matching the due dates of the hedged items. Expected cash flows are continually assessed using historical inflows, budgets and monthly sales forecasts. Hedge effectiveness is assessed on a regular basis. There is no expected ineffec- tiveness at 31 December 2019, primarily because hedging instruments match currencies of hedged cash flows. The financial contracts existing at year-end cover the expected future cash flow for the following number of months: USD CNY1 JPY CAD GBP 2019 2018 9 months 7 months 12 months 9 months 10 months 11 months 6 months 12 months 9 months 11 months 1. Chinese yuan traded offshore (CNH) is used to hedge Novo Nordisk’s CNY currency exposure. 65 Key currencies Exchange rate DKK per 100 2019 2018 2017 USD Average Year-end Year-end change CNY Average Year-end Year-end change JPY Average Year-end Year-end change CAD Average Year-end Year-end change GBP Average Year-end Year-end change 667 668 2.5% 97 96 1.1% 6.12 6.11 3.4% 503 511 6.7% 852 877 6.0% 631 652 5.1% 95 95 (0.3%) 5.72 5.91 7.3% 487 479 (3.2%) 842 827 (1.4%) 660 621 (12.0%) 98 95 (6.9%) 5.88 5.51 (8.6%) 508 495 (5.5%) 849 839 (3.5%) Foreign exchange sensitivity analysis A 5% increase/decrease in the year-end rate in the following currencies versus EUR and DKK would impact Novo Nordisk’s operating profit estimated by Management as outlined in the table below: DKK million USD CNY JPY CAD GBP Estimated for 2020 1,950 450 150 130 100 2019 2,000 350 160 90 85 At year-end, a 5% immediate increase/decrease in all other currencies versus EUR and DKK would affect other comprehensive income and the income statement as outlined in the table below: DKK million 2019 Other comprehensive income Income statement Total 2018 Other comprehensive income Income statement Total 5% increase in all other currencies against DKK and EUR 5% decrease in all other currencies against DKK and EUR (1,811) 199 (1,612) (1,988) 115 (1,873) 1,811 (199) 1,612 1,988 (115) 1,873 A 5% depreciation of USD against all other currencies at 31 December 2019 would affect equity by DKK 1,298 million (2018: DKK 1,604 million) and the income statement by DKK 135 million (2018: DKK 157 million). The foreign exchange sensitivity analysis comprises effects from the Group’s cash, trade receivables and trade payables, current loans, current and non-current financial investments, lease liabilities, foreign exchange forwards and foreign exchange options at year-end. Anticipated currency transactions, investments and non-current assets are not included. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements66 Outside the US, Novo Nordisk has no significant concentration of credit risk related to trade receivables or other receivables and prepayments, as the exposure in general is spread over a large number of counterparties and customers. In the US, the three major wholesalers account for a large proportion of total net sales, cf. note 2.2. However, US wholesaler credit ratings are monitored and a large proportion of the trade receivables are sold on full non-recourse terms; see below for details. Novo Nordisk continues to monitor the credit exposure in Region AAMEO due to the increasing sales and low credit ratings of many countries in this region. Trade receivable programmes Please refer to note 3.5 for the description of the loss allowance for the Group and the ageing analysis. Novo Nordisk’s subsidiaries in the US and Japan employ trade receivable programmes in which trade receivables are sold on full non-recourse terms to optimise working capital. At year-end, the Group had derecognised receivables without recourse having due dates after 31 December 2019 amounting to: DKK million US Japan 2019 3,672 2,149 2018 3,587 1,937 2017 3,328 2,024 In addition, full non-recourse off-balance sheet factoring arrangement programmes are occasionally applied by Novo Nordisk subsidiaries around the world, with limited impact on the Group’s trade receivables. Please refer to note 2.2 for the split of allowance for trade receivables by geographical segment. 4.3 Financial risks (continued) Interest rate risk Novo Nordisk has no significant exposure to interest rate risk as it does not hold any significant interest-bearing marketable securities or non-current loans. Liquidity risk The liquidity risk is considered to be low, and Novo Nordisk has limited debt financing. Novo Nordisk ensures the availability of the required liquidity through a combination of cash management, highly liquid investment portfolios and both uncommitted and committed credit facilities. Novo Nordisk uses cash pools for optimisation and centralisation of cash management. Credit risk Credit risk arises from the possibility that transactional counterparties may default on their obligations, causing financial losses for the Group. Novo Nordisk considers its maximum credit exposure to financial counterparties to be DKK 15,663 million (2018: DKK 15,842 million). In addition, Novo Nordisk considers its maximum credit exposure to trade receivables, other receivables (less prepayments and VAT receivables) and other financial assets to be DKK 26,622 million (2018: DKK 25,065 million). Please refer to note 4.8 for details of the Group’s total financial assets. To manage credit risk regarding financial counterparties, Novo Nordisk only enters into derivative financial contracts and money market deposits with financial counterparties possessing a satisfactory long-term credit rating from at least two out of the three selected ratings agencies: Standard and Poor’s, Moody’s and Fitch. Furthermore, maximum credit lines defined for each counterparty diversify the overall counterparty risk. The table below shows Novo Nordisk’s credit exposure on cash and financial derivatives. Credit exposure for cash at bank and derivative financial instruments (market value) DKK million 2019 AA-range A-range BBB-range Not rated or below BBB-range Total 2018 AA-range A-range BBB-range Not rated or below BBB-range Total Derivative financial instruments Cash at bank 7,471 7,145 314 545 15,475 7,989 7,212 246 191 15,638 139 49 — — 188 90 114 — — 204 Total 7,610 7,194 314 545 15,663 8,079 7,326 246 191 15,842 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements67 Discontinuance of cash flow hedging When a hedging instrument expires or is sold, or when a hedge no longer meets the criteria for hedge accounting, any cumulative gain or loss existing in equity at that time remains in equity and is recognised when the forecast transaction is ultimately recognised in the income statement. When a forecast transaction is no longer expected to occur, the cumulative gain or loss that was reported in equity is immediately transferred to the income statement under financial income or financial expenses. Fair value determination The fair value of derivative financial instruments is measured on the basis of quoted market prices of financial instruments traded in active markets. If an active market exists, the fair value is based on the most recently observed market price at the end of the reporting period. If a financial instrument is quoted in a market that is not active, Novo Nordisk bases its valuation on the most recent transaction price. Adjustment is made for subsequent changes in market conditions, for instance by including transactions in similar financial instruments assumed to be motivated by normal business considerations. If an active market does not exist, the fair value of standard and simple financial instruments, such as foreign exchange forward contracts, interest rate swaps, currency swaps and unlisted bonds, is measured according to generally accepted valuation techniques. Market-based parameters are used to measure the fair value. 4.4 Derivative financial instruments Accounting policies Novo Nordisk uses financial instruments to reduce the impact of foreign exchange on financial results. Use of derivative financial instruments The derivative financial instruments are used to manage the exposure to market risk. None of the derivatives are held for trading. Novo Nordisk uses forward exchange contracts and, to a lesser extent, currency options to hedge forecast transactions, assets and liabilities. The overall policy is to hedge the majority of total currency exposure. Net investments in foreign subsidiaries are currently not hedged. Initial recognition and measurement On initiation of the contract, Novo Nordisk designates each derivative financial contract that qualifies for hedge accounting as one of: • hedges of the fair value of a recognised asset or liability (fair value hedge) • hedges of the fair value of a forecast financial transaction (cash flow hedge). All contracts are initially recognised at fair value and subsequently remeasured at fair value at the end of the reporting period. Fair value hedges Value adjustments of fair value hedges are recognised in the income statement along with any value adjustments of the hedged asset or liability that are attribut- able to the hedged risk. Cash flow hedges Value adjustments of the effective part of cash flow hedges are recognised directly in other comprehensive income. The cumulative value adjustment of these contracts is transferred from other comprehensive income to the income state- ment when the hedged transaction is recognised in the income statement. Derivative financial instruments 2019 2018 DKK million Forward contracts USD1 Forward contracts CNH, JPY, GBP and CAD Forward contracts, cash flow hedges Forward contracts USD Forward contracts CNH, CAD, EUR, GBP and JPY Forward contracts, fair value hedges Total derivative financial instruments Recognised in the income statement Recognised in other comprehensive income Contract amount at year-end Positive fair value at year-end Negative fair value at year-end Contract amount at year-end Positive fair value at year-end Negative fair value at year-end 25,394 10,013 35,407 11,287 3,761 15,048 50,455 81 35 116 61 11 72 188 72 116 315 130 445 217 72 289 734 289 445 29,951 7,462 37,413 9,145 3,268 12,413 49,826 21 23 44 123 37 160 204 160 44 1,555 166 1,721 256 47 303 2,024 303 1,721 1. Average hedge rate for USD cash flow hedges is 654 at the end of 2019 and 610 at the end of 2018. The above financial contracts are expected to impact the income statement within the next 12 months, with deferred gains and losses on cash flow hedges then being transferred to financial income or financial expenses. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements68 4.5 Cash and cash equivalents, financial resources and free cash flow Accounting policies The cash flow statement shows how income and changes in balance sheet items affect cash and cash equivalents, in other words the cash generated or used in the period. The cash flow statement is presented in accordance with the indirect method commencing with net profit for the year. Cash flows in foreign currencies are translated to DKK at the average exchange rate for the respective year. Cash from operating activities converts income statement items from the accrual basis of accounting to cash basis. As such, starting with net profit, non-cash items are reversed and actual payments included. The change in working capital is also taken into account, as this shows the development in money tied up in the balance sheet. Cash from investing activities shows payments related to the purchase and sale of Novo Nordisk’s long-term investments. This includes fixed assets such as construction of new production sites, intangible assets such as patents and licences, and financial assets. Cash and cash equivalents consists of cash offset by short-term bank loans. Where short-term bank loans are consistently overdrawn, they are excluded from cash and cash equivalents. The movement in such facilities is presented under financing activities in the cash flow statement1. Financial resources consist of cash and cash equivalents, marketable securities with original maturity of less than three months and undrawn committed credit facilities expiring after more than one year. Restricted cash Cash and cash equivalents at 31 December 2019 includes DKK 509 million that is restricted (2018: DKK 120 million). The restricted cash balance relates to subsidi- aries in which availability of currency for remittance of funds is temporarily scarce. DKK million 2019 2018 2017 Cash and cash equivalents Cash at bank (note 4.3) Borrowings (bank overdrafts)1 Cash and cash equivalents Financial resources Cash and cash equivalents Undrawn committed credit facility2 Borrowings (bank overdrafts)1 Financial resources3 15,475 (64) 15,411 15,411 11,578 (595) 26,394 15,638 (9) 18,852 (1,694) 15,629 17,158 15,629 11,574 (506) 17,158 8,190 — 26,697 25,348 1. Cash and cash equivalents at the beginning of 2018 has been adjusted for a DKK 412 million bank loan reclassified to financing activities. At 31 December 2019 bank overdrafts classified as financing activities totalled DKK 595 million (2018: DKK 506 million). 2. The undrawn committed credit facility in 2019 is a EUR 1,550 million facility (EUR 1,550 million in 2018 and EUR 1,100 million in 2017) committed by a portfolio of international banks. The facility matures in 2024. 3. Additional non-IFRS financial measure; please refer to 'Financial definitions', which is not part of the audited financial statements. Free cash flow DKK million Net cash generated from operating activities Net cash used in investing activities Net purchase of marketable securities Repayment on lease liabilities 2019 2018 2017 46,782 (11,509) 44,616 (12,080) — (822) — — 41,168 (6,571) (2,009) — Free cash flow4 34,451 32,536 32,588 4. Additional non-IFRS financial measure; please refer to 'Financial definitions', which is not part of the audited financial statements. 4.6 Change in working capital 4.7 Other non-cash items Accounting policies Working capital is defined as current assets less current liabilities and measures the liquid assets Novo Nordisk has available for the business. For the purpose of presenting the cash flow statement, non-cash items with effect on the income statement must be reversed to identify the actual cash flow effect from the income statement. The adjustments are specified as follows: 2018 2017 Other non-cash items DKK million 2019 2018 2017 Change in working capital DKK million Inventories Trade receivables Other receivables and prepayments1 Trade payables Other liabilities1 Adjustment for payables related to non-current assets Adjustment related to divestment of group companies Change in working capital including exchange rate adjustments 2019 (1,305) (2,126) (1,190) (398) 1,202 295 (42) (963) (2,621) (662) 1,146 (348) 84 — (1,032) 69 (17) (401) 265 (1,143) — (3,564) (3,364) (2,259) Exchange rate adjustments 176 (6) (1,375) Cash flow change in working capital (3,388) (3,370) (3,634) 1. Change in working capital includes adjustments in respect of implementation of IFRS 16, please refer to note 1.2. Reversals of non-cash income statement items Interest income and interest expenses, net (note 4.9) Capital gain/(loss) on investments, net etc (note 4.9) Result of associated company (note 4.9) Share-based payment costs (note 5.1) Income from the divestment of group companies Adjustment in non-cash items related to divestment of group companies Increase/(decrease) in provisions (note 3.7) and retirement benefit obligations Other Total other non-cash items 155 145 137 363 (68) 162 6,071 67 7,032 34 (163) (12) 414 (122) — 5,503 444 6,098 21 25 (14) 292 — — 214 1,489 2,027 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements 69 4.8 Financial assets and liabilities Accounting policies The implementation of IFRS 9 from 1 January 2018 resulted in changes to the classification of financial assets. Key changes from the application of IFRS 9 were: From 1 January 2018, Novo Nordisk's investments in minor shareholdings are measured and classified as fair value through the income statement (previously measurement was at fair value through other comprehensive income). From 1 January 2018, all financial assets previously categorised as loans and receivables are classified as financial assets at amortised cost with the exception of certain portfolios of trade receivables which are either sold under master factoring agreements or collected from the customer. These specific portfolios of trade receivables are separately classified and measured at fair value through other comprehensive income. Depending on purpose, Novo Nordisk classifies investments into the following categories: • Financial assets at fair value through the income statement • Financial assets at amortised cost • Financial assets at fair value through OCI Management determines the classification of its financial assets on initial recogni- tion and re-evaluates this at the end of every reporting period to the extent that such a classification is permitted or required. Recognition and measurement Purchases and sales of financial assets are recognised on the settlement date. These are initially recognised at fair value. Fair value disclosures are made separately for each class of financial instruments at the end of the reporting period. Financial assets are removed from the balance sheet when the rights to receive cash flows have expired or have been transferred, and Novo Nordisk has trans- ferred substantially all the risks and rewards of ownership. Financial assets 'at fair value through the income statement' Financial assets at fair value through the income statement consist of equity investments and forward exchange contracts. Equity investments are included in other financial assets unless management intends to dispose of the investment within 12 months of the end of the reporting period. In that case, the current part is included in other receivables and prepayments. Net gains and losses arising from changes in the fair value of financial assets are recognised in the income statement as financial income or expenses. The fair values of quoted investments are based on current bid prices at the end of the reporting period. Financial assets for which no active market exists are carried at fair value based on a valuation methodology. Financial assets 'at amortised cost' Financial assets at amortised cost are cash at bank and non-derivative financial assets solely with payments of principal and interest. Novo Nordisk normally 'holds-to-col- lect' the financial assets to attain the contractual cash flows. If collection is expected within one year (or in the normal operating cycle of the business if longer), they are classified as current assets. If not, they are presented as non-current assets. Trade receivables and other receivables are recognised initially at fair value. Subsequently they are measured at amortised cost using the effective interest method, less allowance for doubtful receivables. Financial assets 'at fair value through other comprehensive income' Financial assets at fair value through other comprehensive income are trade receiv- ables that are held to collect or to sell in factoring agreements. Financial liabilities 'at fair value through the income statement' Financial liabilities at fair value through the income statement consist of forward exchange contracts. Financial liabilities 'at amortised cost' Financial liabilities at amortised cost consist of bank overdrafts, trade payables and other liabilities. Financial assets by category DKK million Financial assets at fair value through the income statement Other financial assets1 Derivative financial instruments (note 4.4) Financial assets at amortised cost Other financial assets1 Trade receivables (note 3.5)2 Other receivables and prepayments (current and non-current) - less prepayments and VAT receivables Cash at bank (note 4.5) Financial assets at fair value through OCI Trade receivables in a factoring portfolio (note 3.5)2 Total financial assets at the end of the year by category1 2019 1,158 970 188 28,418 364 12,203 4,275 (3,899) 15,475 12,709 12,709 42,285 2018 969 765 204 28,340 477 11,188 3,090 (2,053) 15,638 11,598 11,598 40,907 1. Financial assets with the exception of other financial assets and non-current part of other receivables and prepayments (DKK 841 million) are all due within one year. Other financial assets at amor- tised cost include DKK 327 million which are due in more than 5 years (2018: DKK 377 million). Other financial assets measured at fair value through the income statement are minor shareholdings. 2. Trade receivables which are measured at fair value through OCI, which have no associated loss allowance. Financial liabilities by category DKK million Financial liabilities measured at fair value through the income statement Derivative financial instruments (note 4.4) Financial liabilities measured at amortised cost Borrowings (non-current) Borrowings (current) Trade payables Other liabilities - less VAT and duties payable Total financial liabilities at the end of the year by category3 3. Please refer to note 4.2 for a maturity analysis for non-current and current borrowings. All other financial liabilities are due within one year. 2019 734 734 25,448 3,009 1,474 6,358 15,085 (478) 26,182 2018 2,024 2,024 20,936 — 515 6,756 14,098 (433) 22,960 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements4.8 Financial assets and liabilities (continued) For a description of the credit quality of financial assets such as trade receivables, cash at bank, marketable securities, current debt and derivative financial instruments, refer to notes 4.3 and 4.4. 70 Fair value measurement hierarchy DKK million Active market data Directly or indirectly observable market data Not based on observable market data1 Total financial assets at fair value Active market data Directly or indirectly observable market data Not based on observable market data Total financial liabilities at fair value 2019 846 188 12,833 13,867 — 734 — 734 2018 649 204 11,714 12,567 — 2,024 — 2,024 1. The fair value of trade receivables in a factoring portfolio is calculated based on the net invoice amount (invoice amount less charge-backs) less the fee payable to the factoring entity. The factoring fee is insignificant due to the short period between the time of sale to the factoring entity and the invoice due date and the rate applicable. Inputs to the estimate of US wholesaler charge-backs are described in note 2.1. Financial assets and liabilities measured at fair value can be categorised using the fair value measurement hierarchy above. There were no transfers between the ’Active market data’ and ’Directly or indirectly observable market data’ categories during 2019, 2018 or 2017. There are no significant intangible assets or items of property, plant and equipment measured at fair value. Financial impact from forward contracts and currency options, specified DKK million 2018 2019 2017 Forward contracts Income/(loss) transferred from other comprehensive income Value adjustment of transferred contracts Unrealised fair value adjustments of forward contracts Realised foreign exchange gain/ (loss) on forward contracts Financial income/(expense) from forward contracts Currency options Realised income/(loss) transferred from other comprehensive income Value adjustment of transferred options Foreign exchange gain/(loss) on currency options (1,677) 1,841 (2,016) (1,609) (1,299) 2,477 (217) (143) 116 830 1,257 (1,923) (2,673) 1,656 (1,346) — — — — 186 (3) (31) 152 61 (9) (56) (4) 4.9 Financial income and expenses Accounting policies As described in note 4.3, Management has chosen to classify the result of hedging activities as part of financial items in the income statement. Financial items primarily relate to foreign exchange elements and are mainly impacted by the cumulative value adjustment of cash flow hedges transferred from other comprehensive income to the income statement when the hedged transaction is recognised in the income statement. In addition, value adjustments of fair value hedges are recognised in financial income and financial expenses along with any value adjustments of the hedged asset or liability that are attributable to the hedged risk. Finally, value adjustments of foreign currency assets and liabilities in non-hedged currencies will impact financial income and financial expenses. 2019 2018 2017 69 1,163 — — — 14 51 — 1,656 152 251 12 Financial income DKK million Interest income1 Foreign exchange gain (net) Financial gain from forward con- tracts (net) Financial gain from currency options (net) Capital gain on investments, etc. Result of associated companies Total financial income Financial expenses DKK million Interest expenses1 Foreign exchange loss (net) Financial loss from forward con- tracts (net) Financial loss from currency options (net) Capital loss on investments, etc. Result of associated companies Other financial expenses 65 — — — — — 65 2019 220 539 2,673 — 145 137 281 Total financial expenses 3,995 1,755 1,533 1. Total interest income and expenses is measured at amortised cost for financial assets and liabilities. 2,122 1,246 Financial income/(expense) from currency options 2018 85 1,510 — — 88 — 72 2017 90 — 1,346 4 25 — 68 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements Section 5 Other disclosures 5.1 Share-based payment schemes Accounting policies Share-based compensation Novo Nordisk operates equity-settled, share-based compensation plans. The fair value of the employee services received in exchange for the grant of 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 shares granted, excluding the impact of any non-market vesting conditions. The fair value is fixed at the grant date, and adjusted for expected dividends during the vesting period. Non-market vesting conditions are included in assumptions about the number of shares that are expected to vest. At the end of each reporting period, Novo Nordisk revises its estimates of the number of shares expected to vest. Novo Nordisk recognises the impact of the revision of the original estimates, if any, in the income statement and in a corresponding adjustment to equity (change in proceeds) over the remaining vesting period. Adjustments relating to prior years are included in the income statement in the year of adjustment. Share-based payment Expensed in the income statement DKK million Restricted stock units to employees Long-term share-based incentive programme (Management Board)1 Long-term share-based incentive pro- gramme (management group below Management Board) Shares allocated to individual employees Share-based payment expensed in the income statement 2019 48 86 195 34 363 2018 204 2017 169 48 19 145 17 414 102 2 292 1. In 2017 Novo Nordisk introduced, for the first time, a share-based compensation pro- gramme with terms which amortises the grant date valuation over four years. The 2019 expense includes amortisation of the 2017, 2018 and 2019 programmes. Restricted stock units to employees In appreciation of the efforts of employees during recent years, as of 1 August 2019, all employees in the company were offered 75 restricted stock units. A restricted stock unit gives the holder the right to receive one Novo Nordisk B share free of charge in February 2023 subject to continued employment. The cost of the DKK 660 million programme is amortised over the vesting period. 71 Long-term share-based incentive programme Management Board On 4 February 2020, the Board of Directors approved the allocation of a total of 508,398 Novo Nordisk B shares to the members of the Management Board for the 2019 financial year. The value at launch of the programme (adjusted for expected dividends) was DKK 152 million. On average, this corresponds to 14.7 months’ fixed base salary plus pension contribution for the CEO, 11.0 months’ fixed base salary plus pension contribution per executive vice president as of 1 March 2019 and 8.2 months’ fixed base salary plus pension for senior vice presidents. The cost of the 2019 programme is amortised over the vesting period of 2019-2022 at an annual amount of DKK 38 million. The amount of shares allocated may be reduced or increased by up to 30%, depending on whether the average sales growth per year in the three-year vesting period deviates from a target set by the Board of Directors. The grant date of the programme was February 2019, and the share price used for the determining the grant date fair value of the award was the average share price (DKK 322) for Novo Nordisk B shares on Nasdaq Copenhagen in the period 1-15 February 2019, adjusted for expected dividend. Based on the split of partici- pants when the share allocation was decided, 43% of the allocated shares will be allocated to members of Executive Management and 57% to other members of the Management Board. The shares allocated to the joint pool for 2016 were released to the individual participants subsequent to approval of the 2019 Annual Report by the Board of Directors and after the announcement of the 2019 full-year financial results on 5 February 2020. The shares allocated correspond to a value at launch of the programme of DKK 29 million, expensed in 2016. Management group below Management Board The management group below the Management Board has a share-based incen- tive programme with similar performance criteria. For 2019, a total of 1,300,333 shares were allocated to this group, corresponding to a value at launch of the programme (adjusted for expected dividends) of DKK 387 million. The cost of the 2019 programme is amortised over the vesting period of 2019-2022 at an annual amount of DKK 97 million. The amount of shares allocated may be reduced or increased by up to 30%, depending on whether the average sales growth per year in the three-year vesting period deviates from a target set by the Board of Directors. The shares allocated for 2016 were released to the individual participants subse- quent to approval of the 2019 Annual Report by the Board of Directors and after the announcement of the 2019 full-year financial results on 5 February 2020. The shares allocated correspond to a value at launch of the programme of DKK 68 million amortised over the period 2016-2019. The number of shares to be transferred (174,481 shares) is lower than the original number of shares allocated, as some participants had left the company before the programme’s release condi- tions were met. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements 5.1 Share-based payment schemes (continued) General terms and conditions of launched programmes Restricted stock units to employees Shares for Management Board Shares for Management group below Management Board 2019 2018 2017 2019 2018 2017 2019 2018 2017 72 Number of shares awarded in the year Value per share at launch (DKK) Vesting period Allocated to recipients Total market value at launch (DKK million) Amortisation period of the programme 2,148,580 307 3.5 years Feb 2023 660 2019 to 2023 Outstanding restricted stock units Outstanding at the beginning of the year Released restricted stock units to employees Released shares allocated to Management in 2015 Released shares allocated to individual employees Cancelled allocated shares Allocated restricted stock units to employees Shares allocated to Management in the year Shares allocated to individual employees in the year Outstanding at the end of the year Outstanding restricted stock units Restricted stock units to employees 2016 Restricted stock units 2019 Restricted stock units — — — — — — — — — — 508,398 298 3 years Feb 2023 152 2019 to 2022 411,090 280 3 years Feb 2022 356,195 213 3 years Feb 2021 1,300,333 298 3 years Feb 2023 115 2018 to 2021 76 2017 to 2020 387 2019 to 2022 1,114,455 280 3 years Feb 2022 312 2018 to 2021 2019 5,584,019 (1,431,192) (1,040,593) (81,873) (262,596) 2,148,580 1,808,731 154,122 6,879,198 761,826 213 3 years Feb 2021 162 2017 to 2020 2018 4,833,882 (35,180) (764,474) (25,883) (209,308) 100,000 1,525,545 159,437 5,584,019 Released (accu mulated) Issued1 Cancelled (accumulated) Outstanding Value at launch date DKK million Vesting date 1,565,411 2,148,580 (1,475,572) — (89,839) — — 2,148,580 508 660 Q1 2019 Q1 2023 Outstanding restricted stock units to employees 3,713,991 (1,475,572) (89,839) 2,148,580 Shares allocated to Management Board 2015 Shares allocated to joint pool 2016 Shares allocated to joint pool 2017 Shares allocated to joint pool 2018 Shares allocated 2019 Shares allocated 378,943 96,705 356,195 411,090 508,398 (522) (378,421) — (1,623) — (24,608) — (20,077) — — — 95,082 331,587 391,013 508,398 Outstanding shares for Management Board 1,751,331 (378,421) (46,830) 1,326,080 Shares allocated to pools for management group below Management Board 2015 Shares allocated 2016 Shares allocated 2017 Shares allocated 2018 Shares allocated 2019 Shares allocated 879,988 224,055 761,826 1,114,455 1,300,333 (662,172) (217,816) — (49,574) — (100,098) — (77,812) — — 174,481 661,728 1,036,643 — 1,300,333 108 29 76 115 152 251 68 162 312 387 Q1 2019 Q1 2020 Q1 2021 Q1 2022 Q1 2023 Q1 2019 Q1 2020 Q1 2021 Q1 2022 Q1 2023 Outstanding shares for Management group below Management Board Shares allocated to individual employees 4,280,657 323,170 (662,172) (81,873) (445,300) (9,944) 3,173,185 231,353 75 2020-2023 Outstanding at the end of 2019 10,069,149 (2,598,038) (591,913) 6,879,198 All restricted stock units and shares allocated to Management are hedged by treasury shares. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements5.2 Commitments Commitments Total contractual obligations and recognised non-current debt can be specified as follows (payments due by period): The lease commitments are related to IFRS 16 leases primarily for premises and company cars and include the present value of future lease payments during the lease term. Approximately 74% of the commitments are related to leases outside Denmark. 73 The purchase obligations primarily relate to purchase agreements regarding medical equipment and consumer goods. Novo Nordisk expects to fund these commitments with existing cash and cash flow from operations. Research and development obligations include contingent payments related to achieving development milestones. Such amounts entail uncertainties in relation to the period in which payments are due because a proportion of the obligations is dependent on milestone achievements. Exercise fees and subsequent milestone payments under in-licensing option agreements are excluded, as Novo Nordisk is not contractually obligated to make such payments. Commercial product launch milestones include contingent payments solely related to achievement of a commercial product launch following regulatory approval. Commercial milestones, royalty and other payments based on a percentage of sales generated from sale of goods following marketing approval are excluded from the contractual commit- ments analysis because of their contingent nature, related to future sales. The due periods disclosed are based on Management’s best estimate. DKK million Other guarantees 2019 2018 World Diabetes Foundation (WDF) At the Annual General Meeting in 2014, a donation to WDF was approved. For the years 2018-2024, the donation is 0.1% of the Group’s net insulin sales. The annual donation in this period cannot exceed DKK 90 million or 15% of the taxable income of Novo Nordisk A/S in the financial year in question, whichever is lower. Total For 2019, the total donation amounts to DKK 86 million (DKK 85 million in 2018 and DKK 85 million in 2017). 172 5,695 — 2,989 — 1,175 — 621 172 10,480 Other guarantees primarily relate to performance guarantees issued by Novo Nordisk 906 973 2019 DKK million Within 1 year Retirement benefit obligations Leases (note 4.2) 13 847 1-3 years 26 1,424 More than 5 years 1,270 1,140 3-5 years 25 734 Total 1,334 4,145 Total obligations recognised in the balance sheet 860 1,450 759 2,410 5,479 Leases1 128 229 199 376 932 2,600 3,258 1,493 29 7,380 300 1,023 1,009 2,403 4,735 — — — 3,468 3,468 Research and development obligations Research and development - potential milestone payments3 Commercial product launch - potential milestone payments3 Purchase obligations relating to investments in property, plant and equipment Other purchase obligations Total obligations not recog- nised in the balance sheet Total contractual obligations 9,755 8,949 4,635 9,307 32,646 8,895 7,499 3,876 6,897 27,167 2018 DKK million Within 1 year 1-3 years 3-5 years More than 5 years Retirement benefit obligations 13 Total obligations recognised in the balance sheet 13 25 25 25 1,193 1,256 25 1,193 1,256 Operating leases2 1,007 1,463 915 1,511 4,896 Research and development obligations Research and development - potential milestone payments3 Commercial product launch - potential milestone payments3 Purchase obligations relating to investments in property, plant and equipment Other purchase obligations Total obligations not recog- nised in the balance sheet 2,014 1,715 968 75 4,772 550 833 818 2,091 4,292 — — — 2,591 2,591 1,875 4,392 — 2,536 — 1,095 — 406 1,875 8,429 9,838 6,547 3,796 6,674 26,855 Total contractual obligations 9,851 6,572 3,821 7,867 28,111 1. Predominantly relates to estimated variable property taxes, leases committed not yet commenced and low value assets. 2. There were no material finance lease obligations in 2018. 3. Potential milestone payments are associated with uncertainty as they are linked to success- ful achievements in research activities. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements5.3 Related party transactions 5.4 Fee to statutory auditors 74 DKK million 2019 2018 2017 Statutory audit Audit-related services Tax advisory services Other services Total fee to statutory auditors 26 4 11 4 45 25 3 11 3 42 24 4 10 5 43 Fees for services other than statutory audit of the financial statements amount to DKK 19 million (DKK 17 million in 2018 and DKK 19 million in 2017). PricewaterhouseCoopers Statsautoriseret Revisionspartnerselskab (PricewaterhouseCoopers Denmark) provided other services in the amount of DKK 12 million (DKK 9 million in 2018 and DKK 8 million in 2017). Services other than statutory audit of the financial statements provided by PricewaterhouseCoopers Statsautoriseret Revisionspartnerselskab (PricewaterhouseCoopers Denmark) comprise services relating to tax compliance and transfer pricing, educational training, review of social and environmental information, other assurance opinions and agreed-upon procedures, as well as accounting advice. Novo Nordisk A/S is controlled by Novo Holdings A/S (incorporated in Denmark), which owns 28.1% of the share capital in Novo Nordisk A/S, representing 76.1% of the total number of votes. 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. As associated companies of Novo Nordisk A/S, NNIT Group and Churchill Stateside Solar Fund XIV, LLC (‘CS Solar Fund XIV’) are considered related parties. As an associated company of Novo Holdings A/S, Unchained Labs, Inc. is considered a related party to Novo Nordisk A/S. As they share a controlling shareholder, the Novozymes Group and Xellia Pharmaceuticals are also considered to be related parties as well as the Board of Directors or Executive Management of Novo Nordisk A/S. In 2019, Novo Nordisk A/S acquired 14,025,000 B shares, worth DKK 4.9 billion, from Novo Holding A/S as part of the DKK 15.0 billion share repurchase programme. The transaction price for each transaction was calculated as the average market price in the open windows following the announcements of the financial results for the four quarters in 2019. The Group has had the following material transactions with related parties: DKK million 2019 2018 2017 Novo Holdings A/S Purchase of Novo Nordisk B shares Sale of NNIT B shares Dividend payment to Novo Holdings A/S NNIT Group Services provided by NNIT Dividend payment from NNIT Novozymes Group Services provided by Novo Nordisk Services provided by Novozymes CS Solar Fund XIV Purchase of shares by Novo Nordisk Liability for capital commitment Distribution by CS Solar Fund XIV 4,894 — 4,207 (368) — — 5,580 5,496 5,330 941 (20) (132) 103 97 389 (385) 1,052 (19) (115) 121 — — — 1,231 (26) (145) 163 — — — In Novo Nordisk A/S, there were no transactions with the Board of Directors or Executive Management besides remuneration. There were no other transactions with the Board of Directors or Executive Management of NNIT A/S, Novozymes A/S, Novo Holdings A/S, the Novo Nordisk Foundation, Xellia Pharmaceuticals ApS, Unchained Labs or CS Solar Fund XIV. For information on remuneration of the Management of Novo Nordisk, please refer to note 2.4, ‘Employee costs’. There are no loans to the Board of Directors or Executive Management in 2019, nor were there any in 2018 or 2017. There are no material unsettled balances with related parties at the end of the year. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements5.5 Companies in the Novo Nordisk Group Activity: • Sales and marketing • Production • Research and development • Services/investments 75 Percentage of shares owned Activity Company and country Percentage of shares owned Activity Company and country Parent company Novo Nordisk A/S, Denmark Subsidiaries by region • • • • North America Operations 100 • Novo Nordisk Canada Inc., Canada 100 • Novo Nordisk Inc., United States 100 Novo Nordisk US Bio Production, Inc., United States 100 Novo Nordisk US Holdings Inc., United States Novo Nordisk Pharmaceutical Industries LP, United States 100 Novo Nordisk Research Center Indianapolis, Inc., United States 100 100 Novo Nordisk Research Center Seattle, Inc., United States 100 • Novo Nordisk Pharma, Inc., United States • • • • International Operations Novo Nordisk Pharma Operations A/S, Denmark Novo Nordisk Region AAMEO and LATAM A/S, Denmark Region Japan & Korea Novo Nordisk Region Japan & Korea A/S, Denmark Novo Nordisk Pharma Ltd., Japan Novo Nordisk Pharma Korea Ltd., South Korea 100 • 100 100 100 • • 100 • • Region Europe 100 • Novo Nordisk Pharma GmbH, Austria 100 • S.A. Novo Nordisk Pharma N.V., Belgium 100 • Novo Nordisk Pharma d.o.o., Bosnia and Herzegovina 100 • Novo Nordisk Pharma EAD, Bulgaria 100 • Novo Nordisk Hrvatska d.o.o., Croatia 100 • Novo Nordisk s.r.o., Czech Republic 100 • • Novo Nordisk Pharmatech A/S, Denmark 100 Novo Nordisk Region Europe A/S, Denmark 100 • Novo Nordisk Denmark A/S, Denmark 100 • Novo Nordisk Farma OY, Finland 100 • Novo Nordisk, France 100 Novo Nordisk Production SAS, France 100 • Novo Nordisk Pharma GmbH, Germany 100 • Novo Nordisk Hellas Epe., Greece 100 • Novo Nordisk Hungária Kft., Hungary 100 • Novo Nordisk Biopharm Limited, Ireland 100 • Novo Nordisk Limited, Ireland 100 • Novo Nordisk S.P.A., Italy 100 • UAB Novo Nordisk Pharma, Lithuania 100 • Novo Nordisk Farma dooel, Macedonia 100 • Novo Nordisk B.V., Netherlands 100 • Novo Nordisk Scandinavia AS, Norway 100 • Novo Nordisk Pharmaceutical Services Sp. z o.o., Poland Novo Nordisk Comércio Produtos Farmacêuticos Lda., Portugal 100 • 100 • Novo Nordisk Farma S.R.L., Romania 100 • Novo Nordisk Pharma d.o.o. Belgrade (Serbia), Serbia 100 • Novo Nordisk Slovakia s.r.o., Slovakia 100 • Novo Nordisk, d.o.o., Slovenia 100 • Novo Nordisk Pharma S.A., Spain 100 • Novo Nordisk Scandinavia AB, Sweden 100 • Novo Nordisk Health Care AG, Switzerland 100 • Novo Nordisk Pharma AG, Switzerland 100 Novo Nordisk Holding Limited, United Kingdom 100 • Novo Nordisk Limited, United Kingdom 100 Ziylo Limited, United Kingdom • • • • • • • • • 100 • • 100 • 100 • 100 • 100 • 100 100 • 100 • 100 • 100 • 100 • 100 • 100 • Region AAMEO Aldaph SpA, Algeria Novo Nordisk Pharmaceuticals Pty. Ltd., Australia Novo Nordisk Pharma (Private) Limited, Bangladesh Novo Nordisk Egypt LLC, Egypt Novo Nordisk India Private Limited, India Novo Nordisk Service Centre (India) Pvt. Ltd., India PT. Novo Nordisk Indonesia, Indonesia Novo Nordisk Pars, Iran Novo Nordisk Ltd, Israel Novo Nordisk Kazakhstan LLP, Kazakhstan Novo Nordisk Kenya Ltd., Kenya Novo Nordisk Pharma SARL, Lebanon Novo Nordisk Pharma (Malaysia) Sdn Bhd, Malaysia Novo Nordisk Pharma Operations (Business Area) Sdn Bhd, Malaysia 100 Novo Nordisk Pharma SAS, Morocco Novo Nordisk Pharmaceuticals Ltd., New Zealand Novo Nordisk Pharma Limited, Nigeria Novo Nordisk Pharma (Private) Limited, Pakistan Novo Nordisk Pharmaceuticals (Philippines) Inc., Philippines Novo Nordisk Limited Liability Company, Russia Novo Nordisk Production Support LLC, Russia Novo Investment Pte Limited, Singapore Novo Nordisk Pharma (Singapore) Pte Ltd., Singapore Novo Nordisk (Pty) Limited, South Africa Novo Nordisk Lanka (PVT) Ltd, Sri Lanka Novo Nordisk Pharma (Thailand) Ltd., Thailand Novo Nordisk Tunisie SARL, Tunisia Novo Nordisk Saglik Ürünleri Tic. Ltd. Sti., Turkey Novo Nordisk Ukraine, LLC, Ukraine Novo Nordisk Pharma Gulf FZ-LLC, United Arab Emirates 100 • 100 • 100 • 100 • 100 • 100 • 100 100 100 • 100 • 100 • 93 • 100 • 100 • 100 • 100 • • Region China Novo Nordisk (China) Pharmaceuticals Co., Ltd., China Beijing Novo Nordisk Pharmaceuticals Science & Technology Co., Ltd., China Novo Nordisk Hong Kong Limited, Hong Kong Novo Nordisk Pharma (Taiwan) Ltd., Taiwan Region Latin America Novo Nordisk Pharma Argentina S.A., Argentina Novo Nordisk Produção Farmacêutica do Brasil Ltda., Brazil Novo Nordisk Farmacêutica do Brasil Ltda., Brazil Novo Nordisk Farmacéutica Limitada, Chile Novo Nordisk Colombia SAS, Colombia Novo Nordisk Mexico S.A. de C.V., Mexico Novo Nordisk Panama S.A., Panama Novo Nordisk Peru S.A.C., Peru Novo Nordisk Venezuela Casa de Representación C.A., Venezuela Other subsidiaries and associated companies NNE A/S, Denmark NNIT A/S, Denmark Churchill Stateside Solar Fund XIV, LLC, United States 100 • • 100 • • 100 • 100 • 100 • 100 100 • 100 • 100 • 100 • 100 100 • 100 • 100 18 99 Companies without significant activities are not included in the list. NNE A/S subsidiaries are not included in the list. • • • • • • • Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Financial Statements7676 Financial definitions (part of Management's review – not audited) Financial ratios have been calculated in accordance with the guidelines from the Danish Society of Financial Analysts, and supplemented by certain key ratios for Novo Nordisk. Financial ratios are described below and in the section 'Non-IFRS financial measures'. ADR An American Depositary Receipt (or ADR) represents ownership of the shares of a non-US company and trades in US financial markets. Basic earnings per share (EPS) Net profit divided by the average number of shares outstanding. Gross margin Gross profit as a percentage of sales. Net profit margin Net profit as a percentage of sales. Purchase of property, plant and equipment Cash flow statement amount for the purchase of property, plant and equipment. The definition of capital expenditure has been redefined in 2019. Capital expend- iture is now defined as purchase of property, plant and equipment from the cash flow statement. Amounts for 2015-2018 have been restated in the 'Performance highlights'. Diluted earnings per share Net profit divided by average number of shares outstanding, including the dilutive effect of the outstanding restricted stock units. Effective tax rate Income taxes as a percentage of profit before income taxes. Equity ratio Total equity at year-end as a percentage of total assets at year-end. Number of shares outstanding The total number of shares, excluding the holding of treasury shares. Operating margin Operating profit as a percentage of sales. Other comprehensive income (OCI) Other comprehensive income comprises all items recognised in Equity for the year other than those related to transactions with owners of the company. Examples of items that are required to be presented in OCI are: • Exchange rate adjustments of investments in subsidiaries. • Remeasurements of defined benefit plans. • Changes in fair value of financial instruments in a cash flow hedge. Payout ratio Total dividends for the year as a percentage of net profit. Return on equity (ROE) Net profit for the year as a percentage of shareholders’ equity (average). Non-IFRS financial measures (part of Management's review - not audited) In the Annual Report, Novo Nordisk discloses certain financial measures of the Group’s financial performance, financial position and cash flows that reflect adjustments to the most directly comparable measures calculated and presented in accordance with IFRS. These non-IFRS financial measures may not be defined and calculated by other companies in the same manner, and may thus not be comparable. The non-IFRS financial measures presented in the Annual Report are: • Sales and operating profit in constant exchange rates • Operating profit after tax to net operating assets (OPAT/NOA) • Financial resources • Free cash flow • Cash to earnings IFRS refers to an IFRS financial measure. Sales and operating profit growth in constant exchange rates 'Growth in constant exchange rates’ means that the effect of changes in exchange rates is excluded. It is defined as sales/operating profit for the period measured at the average exchange rates for the same period prior year compared with net sales/operating profit for the same period prior year. Price adjustments within hyperinflation countries as defined in IAS 29 ‘Financial reporting in hyperinfla- tion economies’ are excluded from the calculation to avoid growth in constant exchange rates being artificially inflated. Growth in constant exchange rates is considered to be relevant information for investors in order to understand the underlying development in sales and oper- ating profit by adjusting for the impact of currency fluctuations. Sales in constant exchange rates DKK million 2019 2018 2017 Net sales IFRS Effect of exchange rate 122,021 (3,923) 111,831 5,043 111,696 2,609 Sales in constant exchange rates 118,098 116,874 114,305 Net sales previous year 111,831 111,696 111,780 % increase/(decrease) in constant exchange rates % increase/(decrease) in reported currencies 5.6% 9.1% 4.6% 2.3% 0.1% (0.1)% Operating profit in constant exchange rates 2019 DKK million Operating profit IFRS Effect of exchange rate Operating profit in constant exchange rates Operating profit previous year % increase/(decrease) in constant exchange rates % increase/(decrease) in reported currencies 52,483 (2,607) 49,876 47,248 2018 2017 47,248 3,098 48,967 1,770 50,346 50,737 48,967 48,432 5.6% 2.8% 4.8% 11.1% (3.5%) 1.1% Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Part of management´s review − not auditedNovo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Operating profit after tax to net operating assets (OPAT/NOA) Operating profit after tax to net operating assets is defined as ‘operating profit after tax (using the effective tax rate) as a percentage of average inventories, receivables, property, plant and equipment, intangible assets and deferred tax assets less non-interest-bearing liabilities including provisions and deferred tax liabilities (where average is the sum of the above assets and liabilities at the begin- ning of the year and at year-end divided by two). Management believes operating profit after tax to net operating assets is a useful measure in providing investors and Management with information regarding the Group's performance. The calculation of this financial target is a widely accepted measure of earnings efficiency in relation to total capital employed. Solely for the purpose of calculating average net operating assets for 2019, year-end net operating assets for 2018 have been adjusted upwards by DKK 3,778 million to DKK 40,541 million, reflecting the recognition by Novo Nordisk of right- of-use assets of DKK 3,778 million as of 1 January 2019 in accordance with IFRS 16. Comparative figures for 2018 and 2017 have not been restated. Please refer to note 1.2. 7777 Financial resources 'Financial resources at the end of the year' is defined as the sum of cash and cash equivalents at the end of the year, undrawn committed credit facilities less bank overdrafts classified as liabilities arising from financing activities (part of borrowings). Management believes that financial resources at the end of the year are an important measure of the Group's financial strength from an investor's perspec- tive, capturing the robustness of the Group's financial position and its financial preparedness for unforeseen developments. The following table reconciles total financial resources with cash and cash equiva- lents, the most directly comparable IFRS financial measure: Financial resources DKK million Cash and cash equivalents IFRS Undrawn committed credit facilities Borrowings (bank overdrafts) 2019 15,411 11,578 (595) 26,394 2018 2017 15,629 11,574 (506) 17,158 8,190 — 26,697 25,348 The following table shows the calculation of operating profit after tax to net operating assets: Financial resources Operating profit after tax to net operating assets DKK million 2019 2018 2017 Operating profit after tax / Average net operating assets 42,091 42,940 38,318 32,832 38,341 26,776 Operating profit after tax to net operating assets in % 98.0% 116.7% 143.2% OPAT/NOA numerator Reconciliation of operating profit to operating profit after tax: DKK million 2019 2018 2017 Operating profit IFRS 52,483 47,248 48,967 Tax on operating profit (using effective tax rate) (10,392) (8,930) (10,626) Operating profit after tax 42,091 38,318 38,341 Free cash flow Novo Nordisk used to define free cash flow as ‘net cash generated from operating activities’ less ‘net cash used in investing activities’ excluding net change in marketable securities. From 1 January 2019, Novo Nordisk defines free cash flow as ’net cash generated from operating activities’, less ‘net cash used in investing activities’, less repayment on lease liabilities and excluding net change of marketable securities. The updated definition reflects the implementation of IFRS 16, which accordingly has a neutral effect on free cash flow. Free cash flow is a measure of the amount of cash generated in the period which is available for the Board to allocate between Novo Nordisk's capital providers, through measures such as dividends, share repurchases and repayment of debt (excluding lease liability repayments) or for retaining in the business to fund future growth. The following table shows a reconciliation of free cash flow with net cash generated from operating activities, the most directly comparable IFRS financial measure: OPAT/NOA denominator Reconciliation of average net operating assets: IFRS 2019 DKK million 2018 2017 Free cash flow DKK million Intangible assets Property, plant and equipment Deferred income tax assets Other receivables and prepayments (non-current) Inventories Trade receivables Tax receivables Other receivables and prepayments (current) Deferred tax liabilities Retirement benefit obligations Provisions (non-current) Trade payables Tax payables Other liabilities Provisions (current) 5,835 50,551 4,121 841 17,641 24,912 806 3,434 (80) (1,334) (4,613) (6,358) (4,212) (15,085) (31,120) 5,145 41,891 2,893 — 16,336 22,786 1,013 3,090 (118) (1,256) (3,392) (6,756) (4,610) (14,098) (26,161) 3,325 35,247 1,941 — 15,373 20,165 958 2,428 (846) (1,336) (3,302) (5,610) (4,242) (14,446) (20,755) Net operating assets 45,339 36,763 28,900 Average net operating assets 42,9401 32,832 26,776 1. Average net operating assets for 2019 is calculated based on an adjusted net operating assets figure for 2018, which has been adjusted by the right-of-use assets of DKK 3,778 million as of 1 January 2019, following the implementation of IFRS 16. As a consequence, the net operating assets figure for 2018 has been adjusted to DKK 40,541 million for the calculation of the average net operating assets for 2019. Net cash generated from operating activities IFRS Net cash used in investing activities IFRS Net purchase of marketable secu- rities IFRS Repayment on lease liabilities IFRS 2019 2018 2017 46,782 44,616 41,168 (11,509) (12,080) (6,571) — (822) — — (2,009) — Free cash flow 34,451 32,536 32,588 Cash to earnings Cash to earnings is defined as 'free cash flow as a percentage of net profit'. Management believes that cash to earnings is an important performance metric because it measures the Group’s ability to turn earnings into cash. Since Management wants this measure to capture the ability of the Group’s operations to generate cash, free cash flow is used as the numerator instead of net cash flow. The following table shows the calculation of cash to earnings: Cash to earnings DKK million 2019 2018 2017 Free cash flow / Net profit IFRS Cash to earnings 34,451 38,951 88.4% 32,536 38,628 32,588 38,130 84.2% 85.5% Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Part of management´s review − not auditedNovo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Social Statement (supplementary information) 78 Statement of social performance for the year ended 31 December Patients Patients reached with Novo Nordisk's diabetes care products (estimate in millions) Patients reached with Novo Nordisk's diabetes care products via the Access to Insulin Commitment (estimate in millions) Donations (DKK million) Animals purchased for research Employees Employees (total) Employee turnover Employee engagement Gender in management (ratio men:women) Frequency of occupational accidents (number per million working hours) Responsible business Relevant employees trained in business ethics Business ethics reviews Facilitations of the Novo Nordisk Way Supplier audits Product recalls Failed inspections Company trust (scale 0–100) Total tax contribution (DKK million) Note 2019 2018 2017 7.1 7.1 7.2 7.3 8.1 8.1 8.1 8.2 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8 30.0 2.91 105 49,637 43,258 11.4% 91% 60:40 2.2 99% 34 32 236 4 0 78.2 27,527 29.2 0.3 103 65,593 43,202 11.7% 91% 60:40 2.4 99% 33 63 294 3 0 84.5 25,825 27.7 0.3 103 67,623 42,682 11.0% 90% 60:40 2.7 99% 34 65 246 6 0 82.2 — 1. Scope of Access to Insulin Commitment expanded in 2019 to also include middle-income countries and selected organisations providing humanitarian relief. Notes to the consolidated social statement Section 6 Basis of preparation General reporting standards and principles Novo Nordisk's annual reporting complies with the Danish Financial Statements Act. Sections 99a and b specify the requirements of the EU Directive on disclosure of non-financial and diversity information to report on management of risks related to the environment, climate, human rights, labour and social conditions, anti-corruption and gender distribution. This requirement is addressed in the Management Review. Novo Nordisk also adheres to the following internationally recognised voluntary reporting standards and principles: • The UN Guiding Principles Reporting Framework, the only comprehensive guidance for companies to report on how they respect human rights. Novo Nordisk’s implementation of the Guiding Principles on Business and Human Rights is reported at novonordisk.com. • The UK Modern Slavery Act, adopted in 2015, requires commercial organisa- tions operating in the UK to publish an annual slavery and human trafficking statement. Novo Nordisk’s annual statement is available at novonordisk.com. • The International Integrated Reporting Framework, , developed by the International Integrated Reporting Council. The framework consists of a set of content elements and guiding principles intended to improve the quality of information available to providers of financial capital. • The AA1000AP(2018) and AA1000AS(2008) framework, which states that reporting must provide a complete, accurate, relevant and balanced picture of the organisation’s approach to and impact on stakeholders and society. • The Biotechnology & Pharmaceuticals Sustainability Accounting Standard developed by the Sustainability Accounting Standards Board (SASB). The standard consists of a set of topics and accounting metrics companies can use to guide their reporting. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019 79 • The UN Global Compact, a strategic policy initiative for businesses that are committed to aligning their operations and strategies with 10 universally accepted principles in the areas of human rights, labour, environment, anti-cor- ruption and broader UN Goals. Novo Nordisk’s obligation as a participant in the UN Global Compact to provide a Communication on Progress is met by inclusion of material information in the Annual Report and additional informa- tion at novonordisk.com and submitted to the UN Global Compact database at unglobalcompact.org. Principles of consolidation The consolidated social statement and disclosures cover the Novo Nordisk Group comprising Novo Nordisk A/S and entities controlled by Novo Nordisk A/S. Social accounting policies The accounting policies set out below and in the notes have been applied consist- ently in the preparation of the consolidated social statement for all the years presented. Changes to accounting policies and disclosures The following disclosure changes have been made: • 'Patients reached with diabetes care products via the Access to Insulin Commitment' is expanded in scope to reflect new initiatives, effective as of 2019. In addition to the least developed countries, the number now also covers patients reached in selected middle-income countries and through sales to selected organisations providing relief in humanitarian situations. The compara- tive information has not been restated. • 'Fulfilment of action points from the Novo Nordisk Way' is replaced with ‘Facilitations of the Novo Nordisk Way’, to align with the new approach to assessing adherence to the Novo Nordisk Way. • 'Company reputation' is replaced by 'Company trust' as a meaningful proxy for supportive stakeholder behaviours. The methodology has been adjusted and simplified. Other accounting policies Employee engagement Employee engagement is measured on a scale of 1–5 and based on questions relating to employee engagement in the annual employee survey, OurVoice. The score is calculated as the proportion of employees who responded favourably (4 or 5) to relevant questions. For 2019, the response rate was 90% compared with 91% in 2018. Novo Nordisk applies AA1000AP(2018) as a component in creating a generally applicable approach to assessing and strengthening the credibility of the Group’s public reporting of social and environmental information. Novo Nordisk has designed processes to ensure that the qualitative and quantitative information that documents the social and environmental dimensions of performance is assured, as well as the systems that underpin the data and performance. The principles outlined in AA1000AP(2018) have been applied as described below. Inclusivity As a pharmaceutical business with global reach, Novo Nordisk is committed to being accountable to those stakeholders who are impacted by the organisation. From the perspective of social responsibility, the key stakeholder groups are patients who rely on Novo Nordisk products, employees at Novo Nordisk and throughout the Group’s value chain, business partners and local communities. Novo Nordisk maps its stakeholders and has processes in place to ensure inclusion of stakeholder concerns and expectations. In addition, Novo Nordisk continuously develops its stakeholder engagement and capacity to be a sustainable business at corporate, regional and affiliate levels. See how Novo Nordisk defines what is meant by sustainable business in 'Leading a sustainable business'. Materiality Key issues are identified through ongoing stakeholder engagement and trend- spotting, informed by data-driven analysis and addressed by programmes or action plans with clear and measurable targets. Long-term targets are set to guide performance in strategic areas. The issues presented in the Annual Report are deemed to have a significant impact on the Group’s future business performance and may support stakeholders in their decision-making. Responsiveness The Annual Report reflects how the company is managing operations in ways that respond to and consider stakeholder concerns and interests. The report reaches out to a wide range of stakeholders, each with specific needs and interests. The management report is prepared with investors in mind. To these stakeholders, however, as well as to the many other groups who may seek information in the Annual Report, this is just one element of interaction and communication with the company. Impact Understanding, measuring and communicating the positive and negative impacts on society and the environment of Novo Nordisk's activities are important. Novo Nordisk is currently working on developing methodologies to be better able to do just that covering the entire value chain. Applying materiality The consolidated social statement is a result of assessing legal requirements and disclosure commitments applicable to Novo Nordisk. Whether information is tied directly or indirectly to Novo Nordisk’s ability to create value over the short, medium and long term is also assessed. When assessing whether a disclosure is material to include in the consolidated social statement, Management considers whether the matter is of such relevance and importance that it could substantively influence the assessment by providers of financial capital of Novo Nordisk's ability to create value over the short, medium and long term. See more at novonordisk.com. The conclusion from the external assurance provider is available in the 'Independent limited assurance report'. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Social Statement (supplementary information)80 Section 7 Patients 7.1 Patients reached with Novo Nordisk's diabetes care products (estimate) 7.3 Animals purchased for research Accounting policies The record of animals purchased for research comprises the number of animals purchased for all research undertaken by Novo Nordisk either in-house or by external contractors. The number of animals purchased is based on internal regis- tration of purchased animals and yearly reports from external contractors. Animals purchased Number Mice, rats and other rodents Pigs Rabbits Dogs Non-human primates Other vertebrates Total animals purchased 2019 48,081 880 349 157 168 2 49,637 2018 2017 63,547 1,023 641 100 278 4 65,869 835 493 63 241 122 65,593 67,623 The number of animals purchased for research in 2019 decreased by 24% compared with 2018 and reflects the changes in stages of the different research projects. Furthermore the reduction in the number of rodents purchased, reflects Novo Nordisk's continuous focus on reducing the number of animals per research project. 97% of the animals purchased were rodents. Accounting policies The number of full-year patients reached with Novo Nordisk's diabetes care prod- ucts, excluding devices and PrandiMet®, is estimated by dividing Novo Nordisk’s annual sales volume by the annual usage dose per patient for each product class as defined by the World Health Organization (WHO). PrandiMet® is not included as no WHO-defined dosage exists. The number of full-year patients reached with Novo Nordisk's diabetes care prod- ucts via the Access to Insulin Commitment is estimated by dividing Novo Nordisk's annual sales volume in the least developed countries as defined by the United Nations and 29 middle-income countries as defined by the World Bank as well as selected organisations providing relief in humanitarian situations, by the annual usage dose per patient for human insulin in vials as defined by WHO. WHO has not yet assigned a daily dose for Rybelsus®. For this calculation, it is assumed that one tablet equals one patient treatment day. The WHO-defined daily dosage has not changed since 1982, except for Victoza® which was changed in 2019, and may not reflect the recommended or prescribed daily dose accurately. Actual doses are based on individual characteristics (e.g. age and weight) and pharmacokinetic considerations. Despite this uncertainty, Novo Nordisk assesses this to be the most consistent way of reporting. Development The estimated number of full-year patients reached with Novo Nordisk’s diabetes care products increased from 29.2 million in 2018 to 30.0 million in 2019. This 3% increase was primarily driven by sales of long-acting, premix and fast-acting insulins and GLP-1 products. In 2019, the estimated number of patients reached via the Access to Insulin Commitment was 2.9 million, compared with 0.3 million in 2018. The significant increase is due to an expansion of the Access to Insulin Commitment to also include selected middle-income countries as well as selected organisations providing relief in humanitarian situations. Novo Nordisk sold insulin according to this commitment in 31 countries. Beyond this scheme, Novo Nordisk also sold human insulin below the ceiling price in other countries reaching an estimated additional 2.2 million patients in 2019. 7.2 Donations Accounting policies Donations by Novo Nordisk to the World Diabetes Foundation (WDF) and the Novo Nordisk Haemophilia Foundation (NNHF) are recognised as an expense when the dona- tion is paid out or when an unconditional commitment to donate has been made. Donations DKK million 2019 2018 2017 World Diabetes Foundation (WDF) Novo Nordisk Haemophilia Founda- tion (NNHF) Total donations 86 19 105 85 18 103 85 18 103 WDF, an independent trust, supports sustainable partnerships and acts as a catalyst to help others do more. In 2019, WDF provided funding to 12 partnership projects in 11 countries. The projects focus on awareness, education and capacity building at local, regional and global levels. See 'Note 5.2' in the consolidated financial statements and worlddiabetesfoundation.org. Novo Nordisk also provides financial support for improving global access to haemophilia care. NNHF supports programmes in developing and emerging countries. Initiatives focus on capacity building, diagnosis and registry, education and empowerment. Since 2005, NNHF has provided funding for 284 programmes in 75 countries. See nnhf.org. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Social Statement (supplementary information)81 Section 8 Employees 8.1 Employees 8.2 Frequency of occupational accidents Accounting policies The frequency of occupational accidents with absence is measured as the inter- nally reported number of accidents using full-time employees, excluding externals, employees on unpaid leave, interns, bachelor and master thesis employees, and substitutes, per million nominal working hours. An occupational accident with absence is any work-related accident causing at least one day of absence in addi- tion to the day of the accident. Development The average frequency rate of occupational accidents with absence was 2.2 per million working hours in 2019, compared with 2.4 in 2018 due to an 8% decrease in the number of accidents. In 2019, Novo Nordisk had one work-related fatality compared with none in 2018. Novo Nordisk works with a zero-injury mindset and has a long-term commitment to continuously improving safety performance. Accounting policies The number of employees is recorded as all employees except externals, employees on unpaid leave, interns, bachelor and master thesis employees and substitutes at year-end. Employees are attributed to geographical regions according to their primary workplace across the commercial units, research and development, production and support functions. Employees in corporate functions are included in Region Europe and employees in the global service centre in Bangalore, India are included in Region AAMEO (Africa, Asia, Middle-East and Oceania). The rate of turnover is measured as the number of employees, excluding temporary employees, who left the Group during the financial year divided by the average number of employees, excluding temporary employees. Employees working for Group companies that have been disposed are not counted as having left the Group.  Diversity at Novo Nordisk is reported as the percentage split by gender in all mana- gerial positions. Managerial positions are defined as all managers at Novo Nordisk (global job level including Executive Vice Presidents (EVP), Senior Vice Presidents (SVP), Corporate Vice Presidents (CVP), Vice Presidents (VP), General Managers (GM), Directors, Managers and Team Leaders). Employees Number North America Region Europe - of which in Denmark Region AAMEO Region China Region Japan & Korea Region Latin America Total employees Full-time employees Employee turnover Change in employees 2019 6,190 20,980 16,747 7,622 5,263 1,165 2,038 43,258 42,703 11.4% 0% 2018 2017 6,093 22,114 17,461 7,127 4,636 1,268 1,964 6,391 21,920 17,510 6,767 4,482 1,252 1,870 43,202 42,682 42,672 42,076 11.7% 11.0% 1% 1% The underlying growth in employees was mainly driven by Region China. All management teams, from entry level upwards, are encouraged to focus on enhanced diversity, with the aim of ensuring a robust pipeline of talent for management positions. Among employees as a whole, the gender split was 49% women and 51% men in 2019, same as in 2018. The table below shows the gender split among managers. Gender in management Ratio men:women EVP, SVP CVP, VP, GM Director, Manager, Team Leader Gender in management (overall) 2019 82:18 66:34 59:41 60:40 2018 87:13 66:34 60:40 60:40 2017 86:14 67:33 59:41 60:40 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Social Statement (supplementary information)82 Section 9 Responsible business 9.1 Relevant employees trained in business ethics 9.3 Facilitations of the Novo Nordisk Way Accounting policies The mandatory business ethics training is based on the Business Ethics Code of Conduct in the form of globally applicable e-learning, and related tests released annually by the Novo Nordisk Business Ethics Compliance Office. The target groups for the individual tests vary in size and are defined by Novo Nordisk. The target groups are all employees of Novo Nordisk at the end of the reporting period except employees on leave, student assistants, PhDs and postdocs. The percentage of employees completing the training is calculated as the percentage of completion of training in both the Code of Conduct and related tests, based on internal registrations. Development In 2019, as in 2018, 99% of relevant employees were trained in business ethics. 9.2 Business ethics reviews Accounting policies The number of business ethics reviews is recorded as the number of business ethics reviews performed by Group Internal Audit in subsidiaries, production sites and headquarter areas. During a business ethics review, Group Internal Audit will examine procedures and processes in place to ensure ethical behaviour. Any gaps identified in procedures, processes or behaviour are presented to Management and the Board of Directors as findings. An action plan to mitigate findings is agreed between Management and Group Internal Audit, and Group Internal Audit follows up on the implementation of the agreed actions before closing the findings. Accounting policies Facilitations of the Novo Nordisk Way is measured as the number of facilitations and culture coachings completed. Both are internal audit processes for assessing compliance with the Novo Nordisk Way. The assessments are based on review of documentation and feedback from stakeholders followed by an on-site visit during which randomly selected employees and management are interviewed. Identified gaps and improvement opportunities related to the Novo Nordisk Way are presented to management. The facilitators and management agree on an action plan to address those gaps and improvement opportunities. In Q4 2018, culture coaching was introduced as a variation of the facilitation service to support the company-wide culture journey focused on ‘think bigger’, ‘cut complexity’ and ‘be more agile’. Culture coaching builds on the same meth- odology as standard facilitations and is also anchored in the Novo Nordisk Way. In the information below, no distinction is made between a standard facilitation and culture coaching - both are referred to under the term 'facilitations'. Development In 2019, a total of 32 units were facilitated covering approximately 11,000 employees, of whom around 1,500 were individually interviewed. In addition, feedback on those units was collected from approximately 400 stakeholders. The reduction in the number of assignments compared to previous years is mainly a result of merging assignments to cover entire functional areas instead of facili- tating many departments individually. Overall, the 2019 process has shown a high level of adherence to the Novo Nordisk Way. The highest rated Essential continues to be the 'Patient-centred busi- ness approach', while the lowest rated Essential 'Focus on personal performance and development' continues to be an area of improvement despite efforts to raise the level of adherence. Business ethics reviews Number Business ethics reviews Findings 2019 2018 2017 34 87 33 113 34 130 9.4 Supplier audits Based on the completed business ethics reviews, it is Group Internal Audit’s assessment that the business ethics compliance level, in 2019 as in 2018, is sound. Management action plans and closure of findings have progressed as planned, and there were no overdue management actions or findings at the end of the year. Accounting policies The number of supplier audits concluded by Novo Nordisk’s Corporate Quality function includes the number of responsible sourcing audits and quality audits conducted among suppliers. Supplier audits Number Responsible sourcing audits Quality audits Total supplier audits 2019 2018 2017 27 209 236 19 275 294 28 218 246 The number of audits concluded in 2019 decreased by 20% compared with 2018. The decrease in quality audits was due to the additional qualification audits in 2018 supporting, among others, the diabetes API project in the US. There were no critical findings related to the quality audits, but one critical finding was issued in connection with a responsible sourcing audit regarding working hours. An action plan with concrete deadlines has been agreed upon and a responsible sourcing re-audit is planned for 2020 to follow up on improvements. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Social Statement (supplementary information)83 9.5 Product recalls 9.8 Total tax contribution Accounting policies The number of product recalls is recorded as the number of times Novo Nordisk has instituted a recall and includes recalls in connection with clinical trials. A recall can affect various countries. Development Novo Nordisk had four product recalls from the market in 2019, compared with three in 2018. As in 2018, none of the recalls were critical. Local health authorities were informed in all instances to ensure that distributors, pharmacies, doctors and patients received appropriate information. 9.6 Failed inspections Accounting policies The number of failed inspections is measured in relation to the US Food & Drug Administration (USFDA), the European Medicines Agency (EMA), Notified Body (TÜV SUD) and domestic authorities for strategic manufacturing sites. Failed inspections are defined as inspections where Warning Letters or EMA non-com- pliance letters related to GMP inspections are received, GMP/ISO certificates for strategic sites are lost, pre-approval inspections result in a Warning Letter, study conclusions are changed due to GCP/GLP inspection issues, or marketing or import authorisations are withdrawn due to inspection issues. Strategic sites are defined as the manufacturing sites in Brazil, China, Denmark, France and the US. Development In 2019, as in 2018, there were no failed inspections among those resolved at year-end. During the year, 66 inspections were conducted compared with 75 in 2018. At year-end, 44 inspections were passed and 22 were unresolved, as final inspection reports had not been received or the final authority acceptance was pending, which is normal. Follow-up on unresolved inspections continues in 2020. 9.7 Company trust Accounting policies Novo Nordisk’s total tax contribution is measured as the taxes borne or collected by Novo Nordisk, which have been paid in the respective year. Taxes borne are defined as taxes where Novo Nordisk carries the cost. Taxes collected are defined as taxes collected by Novo Nordisk on behalf of others, e.g. employee income taxes deducted from the employee salary and paid on to the government. Tax on company income Tax on company income primarily consists of corporate income taxes and with- holding taxes on company dividends. Employment taxes Employment taxes primarily consist of taxes collected from the employees on behalf of the government and social security costs. Indirect taxes Indirect taxes consist of non-refundable VAT, net VAT collections, customs duties, environmental taxes and property taxes. Other taxes Other taxes consist of country-specific taxes not linked to one of the categories above, e.g. the US branded prescription drug (BPD) fee. The total tax contribution in 2019 amounted to DKK 27,527 million split into 54% on taxes borne and 46% on taxes collected compared with 2018, where the total tax contribution was DKK 25,825 million split into 53% on taxes borne and 47% on taxes collected. Total tax contribution 2019 DKK million Tax on company income Employment taxes Indirect taxes Other taxes Taxes borne Taxes col- lected 10,936 1,642 1,364 887 3,456 7,996 1,246 — Total 14,392 9,638 2,610 887 Total 14,829 12,698 27,527 Accounting policies Company trust is measured annually. The total score is measured as the mean company trust score among people with diabetes, general practitioners and diabetes specialists across key markets. Trust is measured on a scale of 0–100, with 100 being the best possible score. A score above 80 is considered excellent; a score between 70 and 80 is considered strong. Data were collected between June and September 2019. The data are collected through annual surveys carried out by external consultancy firms. Total tax contribution 2018 DKK million Tax on company income Employment taxes Indirect taxes Other taxes Taxes borne Taxes col- lected 9,614 1,571 1,300 1,135 3,392 7,856 957 — Total 13,006 9,427 2,257 1,135 Total 13,620 12,205 25,825 Company trust Scale 0-100 People with diabetes General practitioners Diabetes specialists Total score (average) 2019 78.1 75.3 81.3 78.2 2018 2017 78.6 85.7 89.2 84.5 82.1 78.5 86.0 82.2 The decline in trust can best be explained by the increased scrutiny on pharma throughout 2019, in particular in regards to pricing, access and affordability of medicines, which continues to be reflected in media sentiment and social media conversations. The decline in trust is not unique to Novo Nordisk, but is a trend across the pharma sector. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Environmental Statement (supplementary information)84 Statement of environmental performance for the year ended 31 December Resources Energy consumption for operations (1,000 GJ) Share of renewable power for production sites Water consumption for production sites (1,000 m3) Emissions and waste CO2 emissions from operations and transportation (1,000 tons) Waste from production sites (1,000 tons) Responsible business Breaches of regulatory limit values Note 2019 2018 2017 11.1 11.1 11.2 12.1 12.2 2,993 76% 3,149 306 124 3,099 77% 3,101 278 142 — 79% 3,276 — 157 13.1 16 27 23 Notes to the consolidated environmental statement Section 10 Basis of preparation General reporting standards and principles The consolidated environmental statement has been prepared in accordance with the same standards as those for the consolidated social statement. See 'Section 6 Basis of preparation’ of the consolidated social statement for general overview. In addition, the following standards have been applied: • Recommendations of the Financial Stability Board's Task Force on Climate- related Financial Disclosures (TCFD). TCFD aims to develop voluntary, consistent climate-related financial risk disclosures for use by companies in providing information to investors, lenders, insurers, and other stakeholders. Novo Nordisk’s actions taken in line with the TCFD recommendations are reported at novonordisk.com. • CDP (formerly Climate Disclosure Project). CDP runs a global environmental disclosure system, which supports companies with measuring and managing risks and opportunities related to climate change, water security and deforesta- tion. Novo Nordisk's CDP disclosures are publicly available at cdp.net Principles of consolidation The consolidated environmental statement covers the production sites, laborato- ries and offices with significant activities. CO2 emissions related to transportation cover cars leased or owned by Novo Nordisk, business flights and suppliers distrib- uting Novo Nordisk products. Environmental accounting policies The accounting policies set out below have been applied consistently in the prepa- ration of the consolidated environmental statement for all the years presented. Changes to accounting policies and disclosures The following disclosure changes have been made: • 'Energy consumption for operations’ is expanded in scope from covering all facilities at production sites to also include office buildings and laboratories outside of production sites. Comparative information has been updated accordingly. • 'CO2 emissions from production sites and product distribution' has been taken out. This information is included in 'CO2 emissions from operations and transportation'. • The accounting policy for 'CO2 emissions from business flights', included in the note for 'CO2 emissions' has been updated to include passenger class. Comparative information has been updated accordingly. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Environmental Statement (supplementary information)85 Section 11 Resources 11.1 Energy consumption for operations and share of renewable power Accounting policies Energy consumption for operations is measured as consumption of power, steam, heat and fuel. The fuel is mainly from natural gas, biogas and wood. Energy consumption is based on meter readings and invoices and covers all energy types at production sites and laboratories and consumption of power at office buildings outside of production sites. Share of renewable power used at production sites is reported according to the Greenhouse Gas (GHG) Protocol Scope 2 Guideline. It is calculated as the sum of power in each country that comes from 100% renewable sources, either sourced or self-produced. Energy consumption for operations 1,000 GJ Production Office buildings and laboratories Total energy consumption 2019 2,458 535 2,993 2018 2,502 597 3,099 2017 — — — reduced energy use to produce diabetes finished products. Energy consumption decreased by 10% from offices and laboratories due to various smaller changes across multiple sites. In 2019, 76% of power used at production sites was sourced from renewable energy, a decrease from 77% in 2018. This is due to lower power consumption at the largest production site in Kalundborg, Denmark which uses wind power. With an agreement to have solar power in the United States, effective as of 2020, Novo Nordisk is on track to achieve 100% renewable power at all production sites in 2020. 11.2 Water consumption for production sites Accounting policies Water consumption is measured based on meter readings and invoices. It includes drinking water, industrial water and steam used at production sites. Development In 2019, water consumption at production sites increased slightly by 2% compared with 2018. This was due to an increase in water consumption for production of API for Diabetes and Obesity care. Energy consumption for operations has expanded in scope from covering all facil- ities at production sites to also include office buildings and laboratories outside of production sites. In 2019, energy consumption for operations decreased by 3% compared to 2018. Energy consumption for production decreased 2% due to Three facilities, in Algeria, Brazil and China, are in regions subject to high water stress or large seasonal variations, consuming 14% of the total water for global production. There have been no water shortage incidents in 2019 and overall, water consumption at these facilities increased by 2% in 2019. Section 12 Emissions and waste 12.1 CO2 emissions from operations and transportation Accounting policies CO2 emissions from operations (production, office buildings and laboratories) CO2 emissions from operations cover consumption of power, fuel, heat and steam at office buildings in Denmark, global production sites and laboratories, and consumption of power in office buildings outside Denmark. Emissions are measured in metric tons, calculated according to the GHG Protocol and based on emission factors from the previous year. CO2 emissions from product distribution CO2 emissions from product distribution are calculated by external transportation suppliers as the estimated emissions from product distribution in metric tons. CO2 emissions are calculated based on the worldwide distribution of semi-finished and finished products, raw materials and components by air, sea and road between production sites and from production sites to subsidiaries, direct customers and importing distributors. CO2 emissions from product distribution from subsidiaries to pharmacies, hospitals and wholesalers are not included. CO2 emissions from business flights CO2 emissions from business flights are estimated based on mileage and emission factors for short, medium and long-haul flights along with passenger class obtained from travel agencies. CO2 emissions from company cars CO2 emissions from company cars cover cars leased or owned by Novo Nordisk. Emissions are calculated by multiplying emission factors by the volumes of diesel and gasoline used. CO2 emissions from operations and transportation 1,000 tons 2019 2018 2017 Production Office buildings and laboratories Product distribution Business flights Company cars 86 13 80 65 62 86 28 39 63 62 Total CO2 emissions 306 278 — — — — — — Novo Nordisk has a long-term target of zero CO2 emissions from operations and transportation by 2030. In 2019, CO2 emissions from operations and transportation increased by 10%. The increase was primarily from product distribution, due to an increase in distributed volume, along with using more air freight than sea freight as a result of supply and market driven-challenges. CO2 emissions from global offices and laboratories decreased by 54% in 2019. As part of the new Circular for Zero strategy, all offices and laboratories will source renewable power by 2030. In 2019, there was a significant reduction in CO2 emissions from the R&D site in Beijing, sourcing wind power. CO2 emissions are expected to decrease significantly in 2020 due to various renewable energy projects, including solar power across all US operations, wind power in Europe and green steam in Denmark. Emissions from transportation are also expected to decrease due to a company car policy that encourages transition to hybrid and electric vehicles and through collaboration with EV100. A full breakdown of Scope 1, 2 and 3 emissions from Novo Nordisk can be found at cdp.net. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Environmental Statement (supplementary information) 86 In 2019, waste from production sites decreased by 13% compared with 2018. The amount of waste recycled decreased 8% in 2019 primarily due to a decrease in organic residues from the fermentation of insulin. The amount of waste sent for energy recovery decreased by 36% primarily due to the implementation of a distillation method within API production to reuse ethanol instead of sending it for incineration with energy recovery. In 2019, 93% of the total waste from production sites was recycled, used for biogas production or incinerated at plants where the energy is used for heat and power production. 18% of the waste is categorised as hazardous waste, a decrease from 21% in 2018. This decrease was due to a reduction in ethanol waste from the production of API for Diabetes and Obesity care. 12.2 Waste from production sites Accounting policies Waste is measured as the sum of all the waste disposed of at production sites based on weight receipts. Waste from production sites 1,000 tons Recycling - Organic residues1 - Other (paper, cardboard, metals etc.) Energy recovery2 - Ethanol waste3 - Other (various combustible waste) No energy recovery4 - Water waste - Other Landfill Total waste 2019 2018 2017 97 89 8 18 13 5 8 5 3 1 105 93 12 28 22 6 8 4 4 1 122 116 6 28 21 7 6 5 1 1 124 142 157 1. Organic residues for recycling are waste from the production of the active pharmaceutical ingredients, where the energy is recovered in biogas plants and the digested slurry is used on local farmland as fertiliser. 2. Energy recovery is waste disposed of at waste-to-energy plants and at a biogas plant. 3. Ethanol is used in purification of Diabetes care and Biopharm products. The ethanol is recovered in internal regeneration plants and re-used many times. The ethanol waste reported here is from production with no regeneration or residues from the regeneration process. 4. Water waste and other waste not suitable for other disposal methods, such as hazardous waste for incineration and various other types of waste. Section 13 Responsible business 13.1 Breaches of regulatory limit values Accounting policies Breaches of regulatory limit values cover all breaches reported to the environ- mental authorities. Development In 2019 there were 16 breaches, a decrease from 27 breaches in 2018. The breaches were mainly related to wastewater, and all had minor impact on the environment. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Consolidated Environmental Statement (supplementary information)Consolidated Financial Statements – Management statement 87 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 2019. The Board of Directors and Execu- tive Management are jointly responsible for ensuring the integrity and quality of the report. The Annual Report has been prepared in accordance with the International Inte- grated Reporting Framework. The Consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board and in accordance with IFRS as endorsed by the EU and further requirements in the Danish Financial Statements Act. Further, the Financial statements of the parent company and Management’s review have been prepared in accordance with the Danish Financial Statements Act. Bagsværd, 5 February 2020 Registered Executive Management In our opinion, the Consolidated financial statements and the Financial statements of the parent company give a true and fair view of the financial position at 31 December 2019, the results of the Group’s and parent company’s operations, and consolidated cash flows for the financial year 2019. Furthermore, in our opinion, Management's review includes a true and fair account of the development in the operations and financial circumstances, of the results for the year and of the financial position of the Group and the parent company as well as a description of the most significant risks and elements of uncertainty facing the Group and the parent company. Novo Nordisk’s Consolidated social and environmental statements have been prepared in accordance with the reporting principles of materiality, inclusivity and responsiveness of AA1000APS(2018), and social and environmental accounting policies. They give a true and fair account and a balanced and reasonable pres- entation of the organisation’s social and environmental performance in accordance with these principles. We recommend that the Annual Report be adopted at the Annual General Meeting. Lars Fruergaard Jørgensen President and CEO Karsten Munk Knudsen CFO Monique Carter Camilla Sylvest Mads Krogsgaard Thomsen Henrik Wulff Board of Directors Helge Lund Chair Jeppe Christiansen Vice chair Brian Daniels Laurence Debroux Andreas Fibig Sylvie Grégoire Liz Hewitt Mette Bøjer Jensen Kasim Kutay Anne Marie Kverneland Martin MacKay Thomas Rantzau Stig Strøbæk Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 201988 Independent auditor's report To the shareholders of Novo Nordisk A/S Our opinion In our opinion, the Consolidated Financial Statements give a true and fair view of the Group’s financial position at 31 December 2019 and of the results of the Group’s operations and cash flows for the financial year 1 January to 31 December 2019 in accordance with International Financial Reporting Standards as adopted by the EU and further requirements in the Danish Financial Statements Act. Moreover, in our opinion, the Parent Company Financial Statements give a true and fair view of the Parent Company’s financial position at 31 December 2019 and of the results of the Parent Company’s operations for the financial year 1 January to 31 December 2019 in accordance with the Danish Financial Statements Act. Our opinion is consistent with our Auditor’s Long-form Report to the Audit Committee and the Board of Directors. What we have audited The Consolidated Financial Statements of Novo Nordisk A/S for the financial year 1 January to 31 December 2019, section ‘Consolidated financial statements’, comprise income statement and statement of comprehensive income, cash flow statement, balance sheet, equity statement and notes, including summary of significant accounting policies. The Parent Company Financial Statements of Novo Nordisk A/S for the financial year 1 January to 31 December 2019, section ‘Financial Statements of the Parent Company’, comprise income statement, balance sheet, equity statement and notes, including summary of significant accounting policies. Collectively referred to as the “Financial Statements”. Basis for opinion We conducted our audit in accordance with International Standards on Auditing (ISAs) and the additional requirements applicable in Denmark. Our responsibilities under those standards and requirements are further described in the Auditor’s responsibilities for the audit of the Financial Statements section of our report. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion. Independence We are independent of the Group in accordance with the International Ethics Standards Board for Accountants’ Code of Ethics for Professional Accountants (IESBA Code) and the additional requirements applicable in Denmark. We have also fulfilled our other ethical responsibilities in accordance with the IESBA Code. To the best of our knowledge and belief, prohibited non-audit services referred to in Article 5(1) of Regulation (EU) No 537/2014 were not provided. Appointment We were first appointed auditors of Novo Nordisk A/S in April 1982 for the financial year 1982. We have been reappointed annually by shareholder resolution for a total period of uninterrupted engagement of 38 years including the financial year 2019. Key audit matters Key audit matters are those matters that, in our professional judgement, were of most significance in our audit of the Financial Statements for 2019. These matters were addressed in the context of our audit of the Financial Statements as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters. Key audit matter How our audit addressed the key audit matter Revenue recognition relating to rebates and discounts in the US business The Group sells to various customers in the US, which can fall under certain commercial and government mandated contracts and reimbursement arrange- ments, of which the most significant are Managed Care, Medicare, Medicaid and charge-backs to wholesalers. These arrangements result in deductions to gross sales in arriving at net sales and give rise to obligations for the Group to provide customers with rebates, discounts and allowances, which for unsettled amounts are recognised as an accrual. We focused on this area because rebates, discounts and allowances are complex and because establishing an appropriate accrual requires significant judgement and estimation by Management. This judgement is particularly complex in a US healthcare environment in which competitive pricing pressure and product discounting are growing trends. Refer to note 2.1 and note 3.7. Litigations The pharmaceuticals industry is heavily regulated which increases inherent litiga- tion risk and litigation and contingent liabilities may arise from product-specific and general legal proceedings, from guarantees, marketing practices, unethical behaviour or government investigations connected with the Group’s activities. We focused on this area as the amounts involved are potentially material and the valuation of the provision is based on application of material judgement and estimation and therefore is associated with uncertainty. Accordingly, unexpected adverse outcomes could significantly impact the Group’s reported profit and financial position. Refer to note 3.7. We obtained Management’s calculations for accruals under applicable schemes and assessed the significance of assumptions applied by comparing them to the stated commercial policies, the terms of the applicable contracts, third party data and historical levels of paid rebates and discounts in the US business. We compared the assumptions to contracted prices, historical rebates, discounts, allowances and to current payment trends. We also considered the historical accuracy of the Group’s estimates in previous years. We formed an independent assessment of the most significant elements of the accrual at 31 December 2019 using third party data and compared this expecta- tion to the actual accrual recognised. We discussed the status of significant known actual and potential litigations with in-house legal counsel. We have obtained and substantively tested evidence to support the decisions and rationale for provisions held or decisions not to recog- nise provisions, including correspondence with external legal counsel and other counter-parties and considered Management’s assessment of the probability of defending any litigation and the reliability of estimating any provisions. We assessed litigation history and other available evidence to assess the valuation and completeness of the provisions recognised by the Group. We have obtained confirmations from external legal counsel to confirm our understanding of settled and outstanding litigation and asserted claims. We evaluated significant adjustments to legal provisions recorded during the year to determine if they were indicative of management bias. We tested the completeness of the external legal counsels from whom we have asked for direct confirmation by testing legal expenses on a sample basis and comparing to internal documents. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Independent auditor’s reportStatement on Management’s Review Management is responsible for Management’s Review, section ‘Managements review’. Our opinion on the Financial Statements does not cover Management’s Review, and we do not express any form of assurance conclusion thereon. In connection with our audit of the Financial Statements, our responsibility is to read Management’s Review and, in doing so, consider whether Management’s Review is materially inconsistent with the Financial Statements or our knowledge obtained in the audit, or otherwise appears to be materially misstated. Moreover, we considered whether Management’s Review includes the disclosures required by the Danish Financial Statements Act. Based on the work we have performed, in our view, Management’s Review is in accordance with the Consolidated Financial Statements and the Parent Company Financial Statements and has been prepared in accordance with the requirements of the Danish Financial Statements Act. We did not identify any material misstate- ment in Management’s Review. Management’s responsibilities for the Financial Statements Management is responsible for the preparation of consolidated financial state- ments that give a true and fair view in accordance with International Financial Reporting Standards as adopted by the EU and further requirements in the Danish Financial Statements Act and for the preparation of parent company financial statements that give a true and fair view in accordance with the Danish Financial Statements Act, and for such internal control as Management determines is neces- sary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error. In preparing the Financial Statements, Management is responsible for assessing the Group’s and the Parent Company’s ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless Management either intends to liquidate the Group or the Parent Company or to cease operations, or has no realistic alterna- tive but to do so. Auditor’s responsibilities for the audit of the Financial Statements Our objectives are to obtain reasonable assurance about whether the Financial Statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with ISAs and the additional requirements applicable in Denmark will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these Financial Statements. As part of an audit in accordance with ISAs and the additional requirements appli- cable in Denmark, we exercise professional judgement and maintain professional scepticism throughout the audit. We also: 89 • Obtain an understanding of internal control relevant to the audit in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Group’s and the Parent Company’s internal control. • Evaluate the appropriateness of accounting policies used and the reasonable- ness of accounting estimates and related disclosures made by Management. • Conclude on the appropriateness of Management’s use of the going concern basis of accounting and based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the Group’s and the Parent Company’s ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in our auditor’s report to the related disclosures in the Financial Statements or, if such disclosures are inadequate, to modify our opinion. Our conclusions are based on the audit evidence obtained up to the date of our auditor’s report. However, future events or conditions may cause the Group or the Parent Company to cease to continue as a going concern. • Evaluate the overall presentation, structure and content of the Financial Statements, including the disclosures, and whether the Financial Statements represent the underlying transactions and events in a manner that achieves fair presentation. • Obtain sufficient appropriate audit evidence regarding the financial information of the entities or business activities within the Group to express an opinion on the Consolidated Financial Statements. We are responsible for the direction, supervision and performance of the group audit. We remain solely responsible for our audit opinion. We communicate with those charged with governance regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit. We also provide those charged with governance with a statement that we have complied with relevant ethical requirements regarding independence, and to communicate with them all relationships and other matters that may reason- ably be thought to bear on our independence, and where applicable, related safeguards. From the matters communicated with those charged with governance, we deter- mine those matters that were of most significance in the audit of the Financial Statements of the current period and are therefore the key audit matters. We describe these matters in our auditor’s report unless law or regulation precludes public disclosure about the matter or when, in extremely rare circumstances, we determine that a matter should not be communicated in our report because the adverse consequences of doing so would reasonably be expected to outweigh the public interest benefits of such communication. • Identify and assess the risks of material misstatement of the Financial Hellerup, 5 February 2020 Statements, whether due to fraud or error, design and perform audit proce- dures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our opinion. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrep- resentations, or the override of internal control. PricewaterhouseCoopers Statsautoriseret Revisionspartnerselskab CVR no 3377 1231 Mogens Nørgaard Mogensen State Authorised Public Accountant mne21404 Mads Melgaard State Authorised Public Accountant mne34354 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Independent auditor’s reportIndependent assurance report 90 Independent limited assurance report on the consolidated social and environmental statements for 2019 To the Stakeholders of Novo Nordisk A/S Novo Nordisk A/S engaged us to provide limited assurance on the information described below and set out in the Annual Report of Novo Nordisk for the year ended 31 December 2019. • Performed limited substantive testing on a selective basis of the Selected Information at corporate head office to check that data had been appropriately measured, recorded, collated and reported. • Performed analysis of data from reporting sites, selected on the basis of risk and Our conclusion Based on the procedures we have performed and the evidence we have obtained: A) Nothing has come to our attention that causes us to believe that the Consolidated social and environmental statements of Novo Nordisk’s Annual Report for the year ended 31 December 2019 has not been prepared, in all mate- rial respects, in accordance with the Reporting Criteria. B) Nothing has come to our attention that causes us to believe that the descrip- tion of Novo Nordisk’s alignment with the AA1000 Accountability Principles (AA1000AP) (2018) of Inclusivity, Materiality, Responsiveness and Impact is not fairly stated. This conclusion is to be read in the context of what we say in the remainder of our report. What we are assuring The scope of our work was limited to assurance over: A) The 'Consolidated social statement' and 'The consolidated environmental statement' and associated 'Notes‘, in the Annual Report of Novo Nordisk (the “Selected Information”). B) Novo Nordisk’s description of alignment with the AA1000AP principles of Inclusivity, Materiality, Responsiveness and Impact for the year ended 31 December 2019 which is set out in ‘Basis of preparation‘ in section ‘Consolidated social statement‘ (the “Stakeholder Engagement description”) of the Annual Report. Professional standards applied and level of assurance We performed a limited assurance engagement in accordance with International Standard on Assurance Engagements 3000 (Revised) ‘Assurance Engagements other than Audits and Reviews of Historical Financial Information’ and AA1000 Assurance Standard (AA1000AS, 2008) with 2018 Addendum (Type 2, moderate, which is the equivalent to ISAE 3000 limited assurance). A limited assurance engagement is substantially less in scope than a reasonable assurance engage- ment in relation to both the risk assessment procedures, including an under- standing of internal control, and the procedures performed in response to the assessed risks; consequently, the level of assurance obtained in a limited assurance engagement is substantially lower than the assurance that would have been obtained had a reasonable assurance engagement been performed. Our independence and quality control We have complied with the Code of Ethics for Professional Accountants issued by the International Ethics Standards Board for Accountants, which includes independence and other ethical requirements founded on fundamental principles of integrity, objectivity, professional competence and due care, confidentiality and professional behaviour. We also qualify as independent as defined by the AA1000 Assurance Standard (AA1000AS, 2008) with 2018 Addendum. The firm applies International Standard on Quality Control 1 and accordingly maintains a comprehensive system of quality control including documented policies and procedures regarding compliance with ethical requirements, professional standards and applicable legal and regulatory requirements. Our work was carried out by an independent multidisciplinary team with experience in sustainability reporting and assurance. Understanding reporting and measurement methodologies The Selected Information needs to be read and understood together with the Reporting Criteria, sections ‘Consolidated social statement‘ and ‘Consolidated environmental statement‘, which Novo Nordisk A/S is solely responsible for selecting and applying. The absence of a significant body of established practice on which to draw to evaluate and measure non-financial information allows for different, but acceptable, measurement techniques and can affect comparability between entities and over time. Work performed A) We are required to plan and perform our work in order to consider the risk of material misstatement of the Selected Information. In doing so, we: • Conducted interviews with data owners to understand the key processes and control activities for reporting site performance data. • Obtained an understanding of the key processes and controls for managing, recording and reporting the Selected Information. materiality to the group; and • Considered the presentation and disclosure of the Selected Information. B) In respect of Novo Nordisk’s description of alignment with the AA1000 Accountability Principles (AA1000AP) (2018) of Inclusivity, Materiality, Responsiveness and Impact we performed the following activities: • Interviewed members of Novo Nordisk’s Executive Management team, repre- sentatives responsible for GLP-1 portfolio and market access at global level and in the US, key employees within Corporate Global Patient Access and Corporate Sustainability to determine their understanding of their stakeholders, the mechanisms used to engage them and key issues that are of interest to each stakeholder group. • Interviewed external stakeholders to determine their perception of Novo Nordisk’s capabilities in relation to stakeholder engagement, in particular, in relation to understanding and responding to material patient concerns, needs and desires. • Reviewed evidence on a selective basis to support the assertions made in these interviews and in the Stakeholder Engagement description. • Confirmed the existence of systems and procedures to support Novo Nordisk’s governance for responsible business conduct and stakeholder relationships. Our work focused on priorities and responsible decision-making relating to the development, launch and rollout of oral semaglutide and how this aligns with Novo Nordisk’s ambition of creating a sustainable business; and • Assessed the disclosure and presentation of the Stakeholder Engagement description. Novo Nordisk’s responsibilities Novo Nordisk’s management are responsible for: • Designing, implementing and maintaining internal controls over information relevant to the preparation of the Selected Information that is free from mate- rial misstatement, whether due to fraud or error; • Establishing objective Reporting Criteria for preparing the Selected Information; • Measuring and reporting the Selected Information based on the Reporting Criteria; and • Reporting the Stakeholder Engagement description; and • The content of the Annual Report 2019. Our responsibility We are responsible for: • Planning and performing the engagement to obtain limited assurance about whether the Selected Information and the Stakeholder Engagement description is free from material misstatement, whether due to fraud or error; • Forming an independent conclusion, based on the procedures we have performed and the evidence we have obtained; and • Reporting our conclusion to the Stakeholders of Novo Nordisk A/S. Observations and recommendations According to AA1000AS with 2018 addendum, we are required to include observations and recommendations for improvements in relation to adherence to the AA1000APS principles. We have no significant recommendations regarding Inclusivity, Materiality, Responsiveness and Impact. We have communicated a number of minor recommendations for improvement to the management of Novo Nordisk. Hellerup, 5 February 2020 PricewaterhouseCoopers Statsautoriseret Revisionspartnerselskab (CVR no. 3377 1231) Mogens Nørgaard Mogensen State Authorised Public Accountant mne21404 Mads Melgaard State Authorised Public Accountant mne34354 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Additional information 91 More information Additional reporting Novo Nordisk provides additional disclosure to satisfy legal requirements and stakeholder interests. Supplementary reports can be downloaded from novonordisk.com/annualreport, while additional information can be found at novonordisk.com Materiality Novo Nordisk leans on the International Integrated Reporting Council’s definition of materiality. Information deemed material for providers of finan- cial capital in their decision-making is included in the Annual Report, ie of such relevance and importance that it could substantively influence their assess- ments of Novo Nordisk’s ability to create value over the short, medium and long term. See how Novo Nordisk determines materiality and material issues at novonordisk.com Annual report This Annual Report is Novo Nordisk’s full statutory Annual Report pursuant to Section 149(1) of the Danish Financial Statements Act. Pursuant to section 149(2), a shortened version, consisting of the Management Review and excerpts from the consolidated statements, is available in Danish. In the event of any discrepancies, the full statutory Annual Report shall prevail. The statutory Annual Report will be presented and adopted at the annual general meeting on 26 March 2020 and will subsequently be submitted to and be available at the Danish Business Authority. The Annual Report is prepared in accordance with the International Financial Reporting Standards and the Danish Financial Statements Act. Moreover, it meets the requirements of an integrated report, as per the International Integrated Reporting Framework. The Annual Report also meets the requirements for Communication on Progress to the UN Global Compact, a voluntary reporting on performance towards its 10 principles on human rights, labour rights, environment and anti-corruption and addi- tional progress reporting on corporate sustainability leadership and UN goals. The Annual Report also adheres to the UN Guiding Principles Reporting Framework on respect of human rights. Form 20 F The Form 20-F is filed using a standardised reporting form so that investors can evaluate the company alongside US domestic equities. It is an annual reporting requirement by the US Securities and Exchange Commission (SEC) for foreign private issuers with equity shares listed on exchanges in the United States. Remuneration report The remuneration report includes the total remu- neration received by each member of the Board of Directors and the Executive Management of Novo Nordisk A/S from 2016 to 2018. Corporate governance report The corporate governance report discloses Novo Nordisk’s compliance with Danish Corporate Governance Recommendations to meet the require- ments of the Danish Financial Statements Act. For more news from Novo Nordisk, visit novonordisk.com/investors novonordisk.com/media References 1,5,6,10,11,12,21. International Diabetes Federation. IDF Diabetes Atlas, 9th edition, 2019. 2,13,15,16,17,18,22. World Health Organization. Obesity and Overweight, Fact sheet, 2018. 3. Iorio A. et al. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males, A Meta-analytic Approach Using National Registries. Annals of internal medicine, pp. 1-7, 2019. DOI: 10.7326/ M19-1208. 4. Vimpani G. et al. Prevalence of severe growth hormone deficiency. British Medical journal, pp. 427-430, 1977; Lindsay R. et al. Utah Growth Study: Growth standards and the prevalence of growth hormone deficiency. Pediatric, pp. 29-35, 1994; Thomas M. et al. Prevalence and demographic features of childhood growth hormone deficiency in Belgium during the period 1986–2001. European Journal of Endocrinology pp. 67–72, 2004. 7. Wright et al. Life Expectancy and Cause-Specific Mortality in Type 2 Diabetes: A Population-Based Cohort Study Quantifying Relationships in Ethnic Subgroups. Diabetes care, vol. 40, pp. 338-345, 2017, DOI: 10.2337/dc16-1616. 8. https://www.diabetes.org/diabetes/complications/stroke. 9. https://www. who.int/cardiovascular_diseases/en/. 14. https://www.worldobesity.org/about/about-obesity/prevalence-of-obesity. 19. Diehl A.M.and Day C., Cause, Pathogenesis, and Treatment of Nonalco- holic Steatohepatitis. N Engl J Med 2017. 20. Estes C. et al. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology, pp. 123-133,2018,doi: 10.1002/hep.29466. 23. National Center for Chronic Disease Prevention and Health Promotion, National Diabetes Statistics Report, 2017, Estimates of Diabetes and Its Burden in the United States, pp. 1-20, 2017. 24. Centers for Disease Control & Prevention, Prevalence of Obesity Among Adults and Youth: United States, 2015–2016, pp. 1-8, 2017. 25. Waters H, Graf M. America's Obesity Crisis: The Health and Economic Costs of Excess Weight. pp. 1-30, 2018. Market data on pp 20-21 are from IQVIA, November, 2018 and 2019. Design and production: Kontrapunkt. Digital version: Inviso. Photography: Martin Nordmark, Ulrik Jantzen, Jesper Edvardsen, Jesper Westley, Per Fledelius. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Additional information 92 Product overview Diabetes care New-generation insulin and combinations Tresiba®, insulin degludec Ryzodeg® 70/30, insulin degludec/insulin aspart Fiasp®, fast-acting insulin aspart Xultophy®*, insulin degludec/liraglutide Modern insulin Levemir®, insulin detemir NovoRapid®**, insulin aspart NovoRapid® PumpCart®, pre-filled insulin pump cartridge NovoMix® 30, biphasic insulin aspart NovoMix® 50, biphasic insulin aspart NovoMix® 70, biphasic insulin aspart Human insulin Insulatard®, isophane (NPH) insulin Actrapid®, regular human insulin Mixtard® 30, biphasic human insulin Mixtard® 40, biphasic human insulin Mixtard® 50, biphasic human insulin Glucagon-like peptide-1 Victoza®, liraglutide Ozempic®, semaglutide Rybelsus®, oral semaglutide (only approved in the US) Other pre-filled insulin delivery systems FlexTouch®, U100, U200 FlexPen® InnoLet® Other insulin delivery systems PumpCart®, NovoRapid® cartridge to be used in pump Cartridge Vial Insulin pens NovoPen® 5 NovoPen® 4 NovoPen Echo®, with memory function Needles NovoFine® Plus NovoFine® NovoTwist® NovoFine® AutoCover® Oral antidiabetic agents NovoNorm®, repaglinide Glucagon GlucaGen®, glucagon for diagnostic use GlucaGen® Hypokit, glucagon emergency kit for severe hypoglycaemia Obesity care Glucagon-like peptide-1 Saxenda®, liraglutide 3 mg Biopharm Haemophilia NovoSeven®, recombinant factor VIIa, also available with pre-filled syringe in an increasing number of countries NovoEight®***, recombinant factor VIII NovoThirteen®, recombinant factor XIII Refixia®****, Nonacog beta pegol; N9/GP Esperoct®1, Turoctocog alfa pegol, N8-GP Human growth hormone Norditropin®, somatropin (rDNA origin) Norditropin® FlexPro®, pre-filled multidose delivery system Norditropin® NordiFlex®, pre-filled multi-dose delivery system Norditropin® NordiLet®, pre-filled multi-dose delivery system Norditropin® SimpleXx®, durable multi-dose delivery system NordiPen®, prefilled multi-dose delivery system PenMate®, automatic needle inserter (for NordiPen® and NordiFlex®) Macrilen™, Macimorelin; growth hormone secretagogue receptor agonist Hormone replacement therapy Vagifem®, estradiol hemihydrate Activelle®, estradiol/norethisterone acetate Kliogest®, estradiol/norethisterone acetate Novofem®, estradiol/norethisterone acetate Trisequens®, estradiol/norethisterone acetate Estrofem®, estradiol * in the US approved under the brand name Xultophy® 100/3.6 ** in the US called NovoLog® *** in the US spelt Novoeight® **** in the US approved under the name of REBINYN® 1approved in the US and received positive opinion in EU The product overview on this page makes reference to our 2019 product offering. The names used are European prod- uct trade names with accompanying generic names. Trade and generic names may differ in other markets. Financial calendar 2020 5 February 2020 Financial statement for 2019 and Annual Report 2019 26 March 2020 Annual General meeting 2019 14 August 2020 Ex-dividend 17 August 2020 Record date 18 August 2020 Payment, B shares 27 March 2020 Ex-dividend 25 August 2020 Payment, ADRs 30 October 2020 Financial statement for the first nine months of 2020 Financial calendar 2021 3 February 2021 Financial statement for 2020 and Annual Report 2020 30 March 2020 Record date 31 March 2020 Payment, B shares 7 April 2020 Payment, ADRs 6 May 2020 Financial statement for the first three months of 2020 6 August 2020 Financial statement for the first six months of 2020 Headquarters Novo Nordisk A/S Novo Allé 2880 Bagsværd Denmark Tel +45 4444 8888 CVR number 24 25 67 90 novonordisk.com Investor Service We welcome enquiries and feedback to the Annual Report via novonordisk.com/contact-us.html Shareholders’ enquiries concerning dividend payments and shareholder accounts should be addressed to: shareholder@novonordisk.com ADR holders’ enquiries concerning dividend payments, transfer of ADR certificates, consolidation of accounts and tracking of ADRs should be addressed to: JPMorgan Chase Bank, N.A Toll free number: Phone: 1 800 990 1135 Hearing impaired: Phone: 1 866 700 1652 Outside the U.S.: Phone: +1 651 453 2128 Regular correspondence: Shareowner Services P.O. Box 64504 St. Paul, MN 55164-0504 (From outside the United States) StockTransfer@equiniti.com Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 201993 Financial Statements of the Parent Company 2019 The following pages comprise the financial statements of the parent company, the legal entity Novo Nordisk A/S. Apart from ownership of the subsidiaries in the Novo Nordisk Group, activity within the parent company mainly comprises sales, research and development, production, corporate activities and support functions. Income Statement Balance sheet For the year ended 31 December At 31 December Note 2019 2018 DKK million Note 2019 2018 DKK million Net sales Cost of goods sold Gross profit Sales and distribution costs Research and development costs Administrative costs Other operating income, net Operating profit Profit in subsidiaries, net of tax Financial income Financial expenses Profit before income taxes Income taxes Net profit for the year 2 3 3 3 3 8 4 4 93,440 17,940 75,500 23,619 12,858 1,837 2,204 39,390 10,497 485 3,707 46,665 7,413 39,252 84,752 16,457 68,295 22,215 13,308 1,746 2,214 33,240 11,485 1,970 1,585 45,110 6,580 38,530 Assets Intangible assets Property, plant and equipment Financial assets Deferred income tax assets Other receivables and prepayments Total non-current assets Raw materials Work in progress Finished goods Inventories Trade receivables Amounts owed by affiliated companies Tax receivables Other receivables and prepayments Receivables Derivative financial instruments Cash at bank Total current assets Total assets Equity and liabilities Share capital Net revaluation reserve according to the equity method Development costs reserve Retained earnings Total equity Borrowings Deferred income tax liabilities Other provisions Total non-current liabilities Borrowings Derivative financial instruments Trade payables Amounts owed to affiliated companies Tax payables Other liabilities Total current liabilities Total liabilities 6 7 8 5 9 10 5 11 10 9 11 3,428 24,724 33,876 95 239 62,362 2,357 9,761 2,590 14,708 1,687 14,302 295 1,340 17,624 188 14,067 46,587 108,949 2,799 24,141 28,469 — — 55,409 1,951 9,191 1,922 13,064 1,847 11,544 884 1,001 15,276 204 14,472 43,016 98,425 480 490 15,340 811 40,801 57,432 715 — 995 1,710 165 734 2,673 40,754 74 5,407 49,807 51,517 11,116 1,083 38,816 51,505 — 137 739 876 2 2,024 2,368 36,108 33 5,509 46,044 46,920 98,425 Total equity and liabilities 108,949 Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Financial Statements of the Parent CompanyEquity statement DKK million Balance at the beginning of the year Appropriated from Net profit for the year Total dividend for the year Appropriated from Net profit for the year to net revaluation reserve Effect of cash flow hedges transferred to the income statement Fair value adjustments of cash flow hedges for the year Interim dividends paid during the year Dividends paid for prior year Share-based payments (note 3) Tax credit related to restricted stock units Purchase of treasury shares Reduction of the B share capital Exchange rate adjustments of investments in subsidiaries Development costs Other adjustments Balance at the end of the year Proposed appropriation of net profit: Interim dividend for the year Final dividend for the year Appropriated to Net revaluation reserve Transferred to Retained earnings Distribution of net profit 94 Share capital Net revaluation reserve Develop- ment costs reserve 490 11,116 1,083 4,224 (10) (272) Retained earnings 38,816 15,377 19,651 1,506 (323) (7,100) (12,309) 148 16 (15,334) 10 226 272 (155) 2019 2018 51,505 15,377 19,651 4,224 1,506 (323) (7,100) (12,309) 148 16 (15,334) — 226 — (155) 49,284 22,452 19,547 (3,469) (1,820) (1,506) (7,238) (11,810) 199 (2) (15,567) — 491 — 944 480 15,340 811 40,801 57,432 51,505 7,100 12,551 4,224 15,377 39,252 7,238 12,309 (3,469) 22,452 38,530 Please refer to note 4.1 in the consolidated financial statements regarding average number of shares, treasury shares and total number of A and B shares in Novo Nordisk A/S. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Financial Statements of the Parent CompanyNotes 1 Accounting policies The financial statements of the parent company have been prepared in accord- ance with the Danish Financial Statements Act (Class D) and other accounting regulations for companies listed on Nasdaq Copenhagen. The accounting policies for the financial statements of the parent company are unchanged from the previous financial year except for a change of accounting policy for leases and changed presentation of the balance sheet. The accounting policies are the same as for the consolidated financial statements with the adjust- ments described below. For a description of the accounting policies of the group, please refer to the consolidated financial statements. No separate statement of cash flows has been prepared for the parent company; please refer to the statement of cash flows for the group. Change of presentation of balance sheet The parent company has changed the presentation of the balance sheet to align to the balance sheet for the Group. Deferred tax asset is now being presented as a non-current asset and provisions are now being presented as non-current and current liabilities. The change had no impact on recognised amounts. Change of accounting policy for leasing As of 1 January 2019, the parent company has changed accounting policy for leases from using IAS 17 for interpretation of the Danish Financial Statements Act to using IFRS 16. The parent company implemented IFRS 15 as interpretation for revenue in the financial statements for 2018. The change has been applied by using the modified retrospective approach. Under this method, the cumulative effect of initially applying the standard is recognised at 1 January 2019. Rights-of-use assets and lease liabilities have been recognised for those leases previously classified as operating leases, except for short-term leases and leases of low value assets. The rights-of-use assets have been recognised based on the amount equal to the lease liabilities, adjusted for any related prepaid and accrued lease payments previously recognised. Lease liabilities are recognised based on the present value of the remaining lease payments, discounted using the incremental borrowing rate as of 1 January 2019. The comparative information has not been restated. The weighted average incremental borrowing rate applied on transition to IFRS 16 for parent company was 1.20%. For a description of the transition method used and for a description of the new accounting policies please refer to note 1.2 in the consolidated financial statements. The impact of the change in accounting policy is recognition of additional DKK 1,010 million of property, plant and equipment and DKK 1,010 million of borrowings. The change in policy has had an insignificant impact on the income statement for 2019. Reconciliation of lease liabilities pursuant to change of accounting policy 95 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, using the respective share of the net asset values in subsidiaries and associated companies. Net profit of subsidiaries and associated company less unrealised intra-group profits is recorded in the income statement of the parent companies. To the extent that net profit exceeds declared dividends from such companies, net revaluation of investments in subsidiaries and associated companies are trans- ferred to Net revaluation reserve under equity according to the equity method. Profits in subsidiaries and associated companies are disclosed as profit after tax. Tax For Danish tax purposes, the parent company is assessed jointly with its Danish subsidiaries. The Danish jointly taxed companies are included in a Danish on-ac- count tax payment scheme for Danish corporate income tax. All current taxes under the scheme are recorded in the individual companies. Novo Nordisk A/S and its Danish subsidiaries are included in the joint taxation of the parent company, Novo Holdings A/S. Uncertain tax positions are presented individually as part of Tax receivables/Tax payables. Novo Nordisk recognises deferred income tax assets, if it is probable that sufficient taxable income will be available in the future, against which the temporary differ- ences can be utilised. 2 Sales DKK million Sales by business segment Diabetes and Obesity care Biopharm Total sales Sales by geographical segment North America Operations Region Europe Region China Region AAMEO Region Latin America Region Japan & Korea Total sales 2019 2018 93,192 248 93,440 50,326 16,615 10,326 9,808 3,030 3,335 93,440 84,573 179 84,752 47,942 14,445 8,962 8,490 2,339 2,574 84,752 DKK million Operating leases commitments as disclosed in the parent company’s 2018 financial statement Recognition exemptions: Short-term leases Leases of low value assets Variable lease payments Other Lease liability on transition (undiscounted) Discounted using the parent company’s incremental bor- rowing rate at 1 January 2019 Lease liability recognised on transition 1,296 (23) (24) (187) (7) 1,055 1.20% 1,010 Sales are attributed to geographical segment based on location of the customer. For definitions of segments, please refer to note 2.2 in the consolidated financial statements. 3 Employee costs DKK million Wages and salaries Share-based payment costs Pensions Other social security contributions Other employee costs 2019 10,668 148 1,009 197 393 Total employee costs in the income statement 12,415 Average number of full-time employees Year-end number of full-time employees 15,550 15,442 2018 11,423 199 1,028 212 346 13,208 16,244 16,094 For information regarding remuneration to the Board of Directors and Executive Management, please refer to note 2.4 in the consolidated financial statements. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Financial Statements of the Parent Company96 4 Financial income and financial expenses DKK million Interest income relating to subsidiaries Income from associated company Financial gain from forward contracts (net) Other financial income Total financial income Interest expenses relating to subsidiaries Foreign exchange loss (net) Financial loss from forward contracts (net) Other financial expenses Total financial expenses 2019 432 36 — 17 485 588 426 2,470 223 3,707 2018 297 40 1,300 333 1,970 483 1,018 — 84 1,585 5 Deferred income tax assets/(liabilities) DKK million Net deferred tax asset/(liability) at the beginning of the year Income/(charge) to the income statement Income/(charge) to Equity 2019 2018 (137) 460 (228) (856) 30 689 Net deferred tax asset/(liability) at the end of the year 95 (137) The Danish corporate tax rate was 22% in 2019 (22.0% in 2018). 6 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 Amortisation and impairment losses reversed on disposals during the year Amortisation at the end of the year Carrying amount at the end of the year Intangible assets primarily relate to patents and licences, internally developed software and costs related to major IT projects. 7 Property, plant and equipment DKK million Cost at the beginning of the year Change of accounting policy for leases 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 Land and buildings Plant and machinery Other equipment Assets in course of construction 19,140 965 176 (146) 622 19,063 — 361 (436) 1,828 3,230 45 140 (175) 492 5,859 — 1,344 (21) (2,942) 20,757 20,816 3,732 4,240 49,545 7,365 1,077 55 (145) 8,352 13,834 899 70 (436) 14,367 1,952 307 18 (175) 2,102 — — 21 (21) — 23,151 2,283 164 (777) 24,821 Carrying amount at the end of the year 12,405 6,449 1,630 4,240 24,724 Of which related to leased property, plant and equipment 826 — 51 — 877 Leased property, plant and equipment primary relates to lease of office buildings, warehouses, laboratories and vehicles. 2019 6,032 1,190 (12) 7,210 3,233 271 290 (12) 3,782 3,428 2019 47,292 1,010 2,021 (778) — 2018 4,765 1,267 — 6,032 2,319 914 — — 3,233 2,799 2018 46,099 — 2,791 (1,598) — 47,292 22,685 1,881 112 (1,527) 23,151 24,141 — Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Financial Statements of the Parent Company 8 Financial assets DKK million Cost at the beginning of the year Investments during the year Divestments during the year Cost at the end of the year Value adjustments at the beginning of the year Profit/(loss) before tax Share of result after tax in associated company Income taxes on profit for the year Market value adjustment Dividends received Divestments during the year Effect of exchange rate adjustment Other adjustments Transfer between unrealised internal profit and value adjustment Value adjustments at the end of the year Unrealised internal profit at the beginning of the year Unrealised internal profit movements in the year Effect of exchange rate adjustment Transfer between unrealised internal profit and value adjustment Unrealised internal profit at the end of the year Investments in subsidiaries Amounts owed by affiliated companies Investment in associated company Other securities and investments 97 2018 14,405 3,545 (673) 17,277 30,591 15,329 40 (2,323) 129 (15,694) 44 698 138 — 105 807 391 2019 17,277 5,409 (4,193) 105 1,198 18,493 92 36 (20) (39) (187) 2 28,952 16,514 36 (2,226) (187) (6,320) — 450 (215) (8,201) 267 108 (224) 28,803 28,952 (17,760) (3,791) (70) 8,201 (16,382) (1,521) 143 — — 213 — 974 (13,420) (17,760) 33,876 28,469 8,933 3,744 (3,744) 8,933 28,784 16,514 (2,226) (6,300) 296 (215) (8,201) 28,652 (17,760) (3,791) (70) 8,201 (13,420) 7,432 1,274 (449) 8,257 115 152 — Carrying amount at the end of the year 24,165 8,524 Carrying amount of investments in subsidiaries does not include capitalised goodwill at the end of the year. For a list of companies in the Novo Nordisk group, please refer to note 5.5 to the consolidated financial statements. 9 Derivatives For information on derivative financial instruments, please refer to note 4.4 in the consolidated financial statements. 10 Borrowings DKK million Within 1 year 1-5 years More than 5 years Total borrowings 2019 2018 165 523 192 880 2 — — 2 Borrowings at end of 2019 are related to lease liabilities. 11 Other provisions Provisions for pending litigations are recognised as Other provisions. Furthermore, as part of normal business Novo Nordisk issues credit notes for expired goods. Consequently, a provision for future returns is made, based on historical product return statistics. For information on pending litigations, please refer to note 3.7 in the consolidated financial statements. 12 Related party transactions For information on transactions with related parties, please refer to note 5.3 in the consolidated financial statements. Transactions with CS Solar Fund XIV disclosed in note 5.3 in the consolidated financial statements are not related to the parent company. The parent company’s share of services provided by NNIT Group amounts to DKK 758 million. Novo Nordisk A/S is included in the consolidated financial statements of Novo Nordisk Foundation. 13 Fee to statutory auditors DKK million Statutory audit Audit-related services Tax advisory services Other services Total fee to statutory auditors 14 Commitments and contingencies DKK million Commitments Leases1 Potential milestone payments2 Guarantees given for subsidiaries Other guarantees 2019 2018 8 3 6 3 20 8 3 4 2 17 2019 2018 175 4,464 10,011 130 1,296 3,004 9,898 171 1. Leases for 2019 predominantly relate to estimated variable property taxes and low value assets. Leases for 2018 reflect operating lease commitment. 2. Potential milestone payments are associated with uncertainty as they are linked to successful achievements in research activities; please refer to note 5.2 in the consolidated financial statements. Novo Nordisk A/S and its Danish subsidiaries are jointly taxed with the Danish companies in Novo Holdings A/S. The joint taxation also covers withholding taxes in the form of dividend tax, royalty tax and interest tax. The Danish companies are jointly and severally liable for the joint taxation. Any subsequent adjustments to income taxes and withholding taxes may lead to a larger liability. The tax for the individual companies is allocated in full on the basis of the expected taxable income. For information on pending litigation and other contingencies, please refer to notes 3.7 and 5.2 in the consolidated financial statements. Novo Nordisk Annual Report 2019Novo Nordisk Annual Report 2019Financial Statements of the Parent Company 

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