諾和諾德Novo Nordisk (NVO) 2019年年度報告「NYSE」.pdf

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1、Novo NordiskAnnual Report 2019ROSHNI Roshni has type 1 diabetes and lives in IndiaManagement reviewIntroducing Novo Nordisk01 Letter from the Chair02 Letter from the CEO04 Novo Nordisk at a glance06 Performance highlightsOur business08 Leading a sustainable business11 Innovative treatments and solut

2、ions for unmet needs14 Pipeline overview16 International Operations:Building a sustainable platform for accelerated growth18 North America Operations:Ready for growth in a challenging business environment20 2019 performance and 2020 outlookGovernance29 Managing risks to protect value32 Shares and ca

3、pital structure34 Corporate governance38 Board of Directors40 Executive managementConsolidated statementsConsolidated financial statements42 Income statement43 Cash flow statement44 Balance sheet45 Equity statement46 Notes to the consolidated financial statementsConsolidated social statement(Supplem

4、entary information)78 Statement of social performance78 Notes to the consolidated social statementConsolidated environmental statement(Supplementary information)84 Statement of environmental performance84 Notes to the consolidated environmental statementAdditional information87 Managements statement

5、 and Auditors reports91 More information92 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 sh

6、e was referred to a hospital and enrolled in Novo Nordisks 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

7、 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,a

8、s defined by the Danish Financial Statements Act,is found on pp 1-40 and pp 88-91.This Annual Report is Novo Nordisks full statutory Annual Report 2019.Please read further details in More information.ContentsNovo Nordisk Annual Report 2019Letter from the ChairMaking good progressNovo Nordisk made go

9、od 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.Our strategy is working.Although the challenges facing Novo No

10、rdisk 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

11、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

12、am 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 o

13、n in-house research capabilities will not be enough to sustain success,and we are therefore open-ing our business to strategic partnerships.Novo Nordisks market strength and deep expertise in metabolic diseases makes the company an attractive partner for innova-tive biotech companies.This has allowe

14、d 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

15、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

16、 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-solving this dilemma.And so do the major prevention programmes targeting obes

17、ity 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 h

18、ave 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

19、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 No

20、rdisk 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 t

21、hank 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 Biop

22、harm.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 Nordisks employees for their hard work and commit-ment during 2019;to Lars Fruergaard Jrgense

23、n and his team for their inspiring leadership and to our shareholders for their continued support.Helge LundChair of the Board of Directors1Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo NordiskGovernanceLetter from the CEOSetting new strategic aspirationsOur purp

24、ose 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 o

25、ur 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 co

26、ntribution 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 worlds first and only GLP-1 medicine in a tablet,and early feedback indicates promising prospects

27、.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 strategi

28、c 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 companys performance from this holistic perspective,because that is how we manage

29、 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 the

30、m 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,ob

31、esity,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 w

32、ill 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 ca

33、re,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 sema

34、glutide 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 ha

35、rnessing 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 D

36、icerna.All of these accomplishments demonstrate how we are indeed driving change to benefit patients and delivering convincing results.Results that are 2Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo NordiskGovernancereflected in strong financial performance and a

37、chievement 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-sibi

38、lity to help tackle these challenges.That is what we mean by driving change.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 affor

39、dable 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.We are working with partners across the globe to advance disease prevention through education and on-the-ground inter

40、ventions.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

41、Interna-tional Red Cross,we are providing essential insulin to thousands of people who are affected by humanitarian crises.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 fro

42、m 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.With the Novo Nordisk Way as our guide,we will continue to evolve our culture.To be successful we must se

43、t 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

44、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

45、 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.Lars Fruergaard JrgensenPresident&chief executive officerStrategic aspirations f

46、or 2025 Purpose and sustainability Being respected for adding value to society Progress towards zero environmental impact Ensure distinct core capabilities and evolve culture Innovation and therapeutic focus Further raise the innovation-bar for diabetes treatment Develop a leading portfolio of super

47、ior treatment solutions for obesity Strengthen and progress the Biopharm pipeline Establish presence in Other serious chronic diseases focusing on cardiovascular disease,non-alcoholic steato-hepatitis and chronic kidney disease Commercial execution Strengthen Diabetes care leadership aim at a global

48、 value market share of more than 1/3 Strengthen Obesity care leadership and double current sales Secure a sustained growth outlook for Biopharm Financials Deliver solid sales and operating profit growth Deliver 610%sales growth in International Operations Transform 70%of sales in the USA2 Drive oper

49、ational efficiencies across the value chain to enable investments in future growth assets Deliver free cash flow to enable attractive capital allocation to shareholders1.Based on 2019 sales 2.From 2015 to 20223Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo Nordisk

50、Governance463 million people live with diabetes1650million people live with obesity21.8-2.9in every 10,000 children is born with growth hormone defi ciency4Driving change to defeat diabetes and other serious chronic diseasesNovo Nordisk WaySustainable businessOther serious chronic diseasesEstablish

51、presence by building competitive pipeline and scientifi c leadershipObesity careStrengthen treatment options through market development and by offering innovative medicines and driving patient outcomesOur corporate strategy169 countries with marketed products 43,258 employees world wide80 countries

52、withaffi liates or offi ces 3 continents with research and development facilities1.1million people live with Haemophilia3Diabetes careStrengthen leadership by offering innovative medicines and driving patient outcomesBiopharmSecure a leading position by leveraging full portfolio and expanding into a

53、djacent areasNovo 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.Novo Nordisk at a g

54、lanceNovo Nordisk Annual Report 20194Our businessConsolidated statementsIntroducing Novo NordiskGovernanceFinanciallyresponsibleSociallyresponsibleEnvironmentallyresponsibleResourcesValue createdFinancial resourcesInsights from healthcare experts and patientsRaw materials,water and energyExpertise f

55、rom academic institutionsManufactured goodsDiverse talent43,258 employees of which 5,507 new hiresDKK 27,527 million total tax contributionDKK 34,743 million to shareholders as dividends and share repurchases30 million people using Novo Nordisk Diabetes care productsApprox.5,000 investigator sites a

56、ctive in Novo Nordisk-sponsored clinical trialsEngineering,formulating,developing and delivering protein-based treatmentsEffi cient large-scale production of proteinsGlobal commercial reach and leader in chronic disease careCore capabilitiesFinancially responsibleEnvironmentally responsibleSocially

57、responsibleMore than 1 billion insulin penfi llsproducedDeep disease understandingOur business modelOur 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 resour

58、ces and leverage our core capa-bilities to create value for patients,employees,partners and shareholders.Adding value to societyThe companys Articles of Association spell out the obligation to do business in a financially,environmentally and socially responsible way.This approach is applied to ensur

59、e 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.5Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo NordiskGovernancePerformance highlightsDKK million

60、2015201620172018201920182019Financial performanceChangeNet sales107,927111,780111,696111,831122,0219%Sales growth in constant exchange rates18.4%5.5%2.3%4.6%5.6%Net sales growth as reported21.5%3.6%(0.1%)0.1%9.1%Operating profit49,44448,43248,96747,24852,48311%Net financials(5,961)(634)(287)367(3,93

61、0)Profit before income taxes43,48347,79848,68047,61548,5532%Net profit for the year34,86037,92538,13038,62838,9511%Total assets91,79997,539102,355110,769125,61213%Equity46,96945,26949,81551,83957,59311%Purchase of property,plant and equipment15,2247,0687,6269,6368,932(7%)Free cash flow134,22239,9913

62、2,58832,53634,4516%Financial ratios1Percentage of sales:Gross margin85.0%84.6%84.2%84.2%83.5%Operating margin45.8%43.3%43.8%42.2%43.0%Net profit margin32.3%33.9%34.1%34.5%31.9%Sales and distribution costs26.2%25.4%25.4%26.3%26.1%Research and development costs12.6%13.0%12.5%13.2%11.7%Administrative c

63、osts3.6%3.5%3.4%3.5%3.3%Equity ratio51.2%46.4%48.7%46.8%45.8%Return on equity79.9%82.2%80.2%76.0%71.2%Cash to earnings98.2%105.4%85.5%84.2%88.4%Payout ratio46.6%50.2%50.4%50.6%50.5%Long-term financial targets1TargetOperating profit growth43.3%(2.0%)1.1%(3.5%)11.1%5%Operating profit growth adjusted23

64、5.2%3.9%1.1%(3.5%)11.1%Operating profit growth in constant exchange rates adjusted212.7%6.2%4.8%2.8%5.6%Operating profit after tax to net operating assets148.7%150.2%143.2%116.7%98.0%80%Cash to earnings(three-year average)96.8%102.4%96.4%91.7%86.0%85%The Group has applied IFRS 16 Leases for the firs

65、t 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

66、 for inflammatory disorders respectively.201980%8%6%5%1%Sales by therapeutic area Diabetes care Obesity care Haemophilia Growth disorders Other Biopharm20194%5%11%11%19%50%Sales by geographic area Region Europe Region AAMEO Region China Region Japan&Korea Region Latin America North America Operation

67、s20152016201720182019Million051015202530Patients reached with diabetes care products(estimate)Ceiling price*Regular pricing*Patients reached with insulin below ceiling price of USD 4.00/vial of human insulin.6Novo Nordisk Annual Report 2019Our businessConsolidated statementsIntroducing Novo NordiskG

68、overnanceWater consumption Locations with high water stress or large seasonal variations*Other locations 201914%86%*As defined by the World Resource Institute CO2 emissions from operations and transportation Company cars Business flights Product distribution Office buildings and laboratories Product

69、ion201929%4%21%20%26%2015201620172018201901020304050ThousandEmployees(total)Region Europe Region AAMEO Region China Region Japan&Korea Region Latin America North America Operations Performance highlights2015201620172018201920182019Social performanceChangePatients reached with Novo Nordisks diabetes

70、care products(estimate in millions)26.828.027.729.230.03%Patients reached with Novo Nordisks diabetes care products via the Access to Insulin Commitment(estimate in millions)0.30.32.93Employees(total)41,12242,44642,68243,20243,2580%Employee turnover9.2%9.7%11.0%11.7%11.4%Gender in management(ratio m

71、en:women)59:4159:4160:4060:4060:40Relevant employees trained in business ethics98%99%99%99%99%Product recalls2663433%Failed inspections00000Long-term social targetsTargetEmployee engagement90%91%91%90Company trust(scale 0100)82.284.578.2 80Environmental performanceChangeWater consumption for product

72、ion sites(1,000 m3)3,1313,2933,2763,1013,1492%Waste from production sites(1,000 tons)159153157142124(13%)Long-term environmental targets TargetShare of renewable power for production sites78%78%79%77%76%100%by 2020CO2 emissions from operations and transportation(1,000 tons)2783060 by 2030Share perfo

73、rmanceChangeBasic earnings per share/ADR in DKK113.5614.9915.4215.9616.413%Diluted earnings per share/ADR in DKK113.5214.9615.3915.9316.383%Total number of shares(million),31 December2,6002,5502,5002,4502,400(2%)Dividend per share in DKK6.407.607.858.158.3542%Total dividend(DKK million)16,23019,0481

74、9,20619,54719,65141%Share repurchases(DKK million)17,22915,05716,84515,56715,334(1%)Closing share price(DKK)399.90254.70334.50297.90386.6530%1.See Financial definitions.3.Scope of Access to Insulin Commitment expanded in 2019 to also include middle-income countries and selected organisations providi

75、ng 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.7Novo Nordisk Annual Report 2019Our

76、businessConsolidated statementsIntroducing Novo NordiskGovernancePurpose and sustainability:Leading a sustainable businessOur 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

77、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.In 2019,we entered a partnership with UNICEF to develop intervention

78、s 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-ma

79、kers 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 driv

80、e 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 s

81、it-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 medici

82、nes 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

83、 health and thereby help contain the vast societal and financial burden arising from chronic diseases.Access to affordable care for vulnerable populationsNovo Nordisk operates in 169 countries with vastly different levels of income and Strategic aspirations for 2025Purpose and sustainability Being r

84、espected for adding value to society Progress towards zero environmental impact Ensure distinct core capabilities and evolve culture8Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo NordiskOur businessThere will not be resources to provide for adequate chronic care fo

85、r 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

86、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 oper

87、ations,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 climat

88、e 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 obesityIn a world

89、 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 impa

90、ct 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

91、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 righ

92、t,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.Introducing Novo NordiskOur businesshealth systems.As a global healthcare company,we know that different ap-proaches are needed to ensure

93、 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 U

94、SD 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 worlds poorest countries

95、.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 h

96、umanitarian 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

97、-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

98、 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 USEnsuring affordability of medicines within the complex US healthcare system contin-ues to be a high priority.This year

99、,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-

100、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 Fl

101、exPen/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 f

102、or 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 patient

103、s.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 p

104、harmacy chains.Our Co-pay Savings Cards help spread the costs of commercially insured pa-tients with high out-of-pocket costs.Pursuing zero environmental impactOur long-standing climate action efforts are paying off.We expect to meet our target of using only renewable power in our production by 2020

105、.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 t

106、ransport 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

107、 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 ex

108、isting and design new products based on circular principles and solve the end-of-life product waste challenge to close the resource loop.Sustainable business approachAs a business with global reach,we are defining our role in contributing to an environment,society and economy that enables all people

109、,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,i

110、ncluding 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 P

111、ractices 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 asse

112、ssments 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

113、in a global context,we follow a robust approach to identify current state and required actions through a focused,long-term effort.9Novo Nordisk Annual Report 2019Consolidated statementsGovernanceGuided by the Novo Nordisk WayWe build our business on a principled approach to always doing business in

114、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

115、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

116、 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

117、 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 ap

118、praised 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 res

119、ponsibility 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

120、and assurance,in adherence with international standards.Evolving our cultureNovo 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 prot

121、ein-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 cul

122、ture 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

123、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 diabete

124、s,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 devel

125、opment 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

126、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 bring

127、ing Rybelsus faster to the market to the benefit of patients.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 Nor

128、disks 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-cov

129、er,enable and accelerate concepts and projects that will expand and diversify our pipeline with disruptive medicines.Novo Nordisks Essentials1 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,envir

130、onmental 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 s

131、trive for agility and simplicity in everything we do.10 We never compromise on quality and business ethics.10Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo NordiskOur businessInnovation and therapeutic focus:Innovative treatments and solutions to unmet needsincome c

132、ountries.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

133、 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

134、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 peop

135、le 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 d

136、iabetes care segment,insulin is still 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 o

137、f 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 therapeuti

138、c 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 ad

139、vance the development of medical devices and digital health solutions.Strengthen leadership in Diabetes careThere 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

140、 are now estimated to have diabetes5,and eight out of ten live in low-and middle-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.Further raise the innovation-bar for diabetes treat

141、ment 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 diseaseStrategic aspirations for 2025Inn

142、ovation and therapeutic focusDiabetes is associated with shorter life expectancy and lower quality of lifeDiabetesLife expectancy 8 years shorter7Driven by 200%increased risk of all-cause mortality12CVD70%of people with diabetes die from atherosclerotic CVD9150%increase in risk of stroke8OrgansHighe

143、r likelihood of neuropathy,retinopathy,limb amputation,cancer and cognitive dysfunction InsulinGLP-1Further raise the innovation bar for diabetes treatmentCurative treatmenttimeInnovation levelOral GLP-1 analogueWeekly GLP-1analogueGLP-1analogueNative GLP-1Glucose-sensitiveInsulinLong-actingInsulin

144、analogueOnce-weekly11Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo NordiskOur businessimportant 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 deve

145、lop 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 al

146、so 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 th

147、e 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

148、 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

149、 benefits of our treatments.Strengthen treatment options in Obesity careAround 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

150、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.16Still,obesity is not widely recognised as a disease that may require medical tr

151、eat-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

152、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

153、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

154、 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

155、 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 dev

156、elopment 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 BiopharmOur Biopharm business is a stro

157、ng speciality care unit that encompasses rare blood and rare endocrine disorders,both areas of significant unmet medical need.While Biopharms performance has been resilient and robust the future is not straightforward,due to intense competi-tion and slower growth in the haemophilia and growth hormon

158、e 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 millionadults have obesity13120 millionchildren have obesity153.

159、4 milliondeaths were caused by obesity in 2010172 trillion US dollars in annual global cost of obesity16Develop a leading portfolio of superior treatment solutions for obesityLaunchedSaxenda%Weight loss over timeTreatment gapPhase 3 Semaglutide ObesityTodays available medicationBariatric surgeryPhas

160、e 2AM833Phase 1PYY 1875Tri-agonist GG-co-agonistLA-GDF15 AM833+Sema30252015105Strengthen and progress the Biopharm pipelineCurativetherapyNon-invasivetherapyMim8ConcizumabEsperoctRefixiaNovoEightNovoThirteenNovoSevenInnovation in haemophiliafuture1986today12Novo Nordisk Annual Report 2019Consolidate

161、d statementsGovernanceIntroducing Novo NordiskOur businessdeveloping 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,

162、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 expandi

163、ng 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 a

164、utomat-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

165、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 treatm

166、ent 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

167、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

168、 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 signific

169、antly 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-alco

170、holic 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

171、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 pharmaceu

172、tical 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.

173、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 thes

174、e.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 st

175、akeholders.New technologies,including stem cell-based therapies,will help this expansion into new therapeutic areas such as Parkinsons disease,dry age-related macular degenera-tion,and chronic heart failure.Forming the right strategic alliances and transforming the way we deliver innovation will hel

176、p us achieve our aspirations in this area.Establish presence in Other serious chronicdiseasesCVDCKDNASHStem Cells13Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo NordiskOur businessPipeline overviewDiabetes careProjectIndicationDescriptionPhaseRybelsusNN9924Type 2 d

177、iabetesA long-acting oral GLP-1 analogue intended for once-daily oral treatment.Anti-IL-21 GLP-1 T1DNN9828Type 1 diabetesA beta-cell preservation treatment intended for adults who are newly diagnosed with type 1 diabetes.Insulin icodec(LAI287)NN1436Type 1 and 2 diabetesA long-acting basal insulin an

178、alogue intended for once-weekly treatment.Insulin 965NN1965Type 1 and 2 diabetesA novel basal insulin analogue intended for once-daily treatment.Icosema(LAISema)NN1535Type 2 diabetesCombination of the GLP-1 analogue semaglutide and the long-acting basal insulin icodec intended for once-weekly treatm

179、ent.Obesity careSemaglutide ObesityNN9536ObesityA long-acting GLP-1 analogue intended for once-weekly treatment.AM833NN9838ObesityA novel long-acting amylin analogue intended for once-weekly treatment.AM833 and semaglutideNN9838ObesityA combination of the novel amylin analogue and the GLP-1 analogue

180、 semaglutide intended for once-weekly treatment.LA-GDF15NN9215ObesityA long-acting GDF15 analogue intended for appetite regulation leading to weight loss.GG-co-agonist 1177NN9277ObesityA glucagon and GLP-1 receptor co-agonist intended for once-weekly treatment.PYY1875NN9775ObesityA novel analogue of

181、 the appetite-regulating hormone,PYY,intended for once weekly treatment.Tri-agonist 1706NN9423ObesityA novel tri-agonist of the human GIP,GLP-1 and glucagon receptors intended for once-daily treatment.HaemophiliaConcizumabNN7415Haemophilia A and B with or without inhibitorsA monoclonal antibody agai

182、nst tissue factor pathway inhibitor intended for subcutaneous prophylaxis treatment.EclipseNN7533Sickle cell disease and beta thalassaemiaAn oral combination treatment of sickle cell disease.Project is developed in collaboration with EpiDestiny.Mim8NN7769Haemophilia A with or without inhibitorsA nex

183、t-generation FVIII mimetic bispecific antibody for subcutaneous prophylaxis of haemophilia A regardless of inhibitor status.Combined phase 1/2.Growth disorderSomapacitan AGHDNN8640Adult growth hormonedeficiencyA long-acting human growth hormone analogue intended for once-weekly subcutaneous administ

184、ration in adults.Somapacitan GHDNN8640Growth hormonedeficiencyA long-acting human growth hormone analogue intended for once-weekly subcutaneous administration in children.NASH(non-alcoholic steatohepatitis)SemaglutideNN9931NASHA long-acting GLP-1 analogue for treatment of NASH.Gilead:Sema comboNN993

185、1NASHA 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.Cardiovascular diseasePCSK9i peptide NN6434CVDA long-acting PCSK9 inhibitor for subcutaneous treatment.14Novo

186、Nordisk Annual Report 2019Consolidated statementsGovernance14Novo Nordisk Annual Report 2019Consolidated statementsGovernanceNovo Nordisk Annual Report 2019Introducing Novo NordiskOur business2020 expected key milestonesOral semaglutideRegulatory decision in JapanAM833Phase 2 results from Amylin in

187、obesitySemaglutidePhase 2 results for semaglutide in NASHSemaglutidePhase 3 results for semaglutide in obesityOzempicPhase 3 results for 2 mg OzempicSomapacitanRegulatory decision for AGHD in the US and the EUPatent status for marketed productsThe patent expiry dates for the product portfolio are sh

188、own 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 pa

189、tents 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)USAChinaJapanGermanyDia

190、betes:Human insulinExpiredExpiredExpiredExpiredNovoRapid(NovoLog)ExpiredExpiredExpiredExpiredNovoMix 30(NovoLog Mix 70/30)ExpiredExpiredExpiredExpiredNovoNorm(Prandin)ExpiredExpiredExpiredExpiredLevemirExpiredExpiredExpiredExpiredVictoza2023Expired20222023Tresiba2029202420272028Ryzodeg20292024202422

191、028Xultophy20292024202422028Fiasp(2030)3(2030)3(2030)3(2030)3Ozempic203112026203112031Rybelsus20311,72026720311,720317Obesity:Saxenda2023ExpiredExpired2023Haemophilia,growth disorders and hormone replacement therapy:Norditropin(Norditropin SimpleXx)ExpiredExpiredExpiredExpiredMacrilenTM20278N/AN/AN/

192、ANovoSevenExpired4Expired4Expired4Expired4NovoEightN/AN/AN/AN/ANovoThirteen(TRETTEN)2021N/AExpiredExpiredRefixia(REBINYN)2028120222027120271Esperoct2032120292034120341Vagifem 10 mcg20225,6N/A20215N/A1.Current estimates.2.Patent term extension until 2027 may apply.3.Formulation patent;active ingredie

193、nt 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 protect

194、ed by additional patents expiring in 2031-2034.8.Protects method of use and kits of parts.15Novo Nordisk Annual Report 2019Consolidated statementsGovernance15Novo Nordisk Annual Report 2019Consolidated statementsGovernanceNovo Nordisk Annual Report 2019Introducing Novo NordiskOur businessCommercial

195、execution:International Operations:Building a sustainable platform for accelerated growth Strengthen Diabetes care leadership aim at a global value market share of more than 1/3 Strengthen Obesity care leader-ship and double current sales Secure a sustained growth outlook for Biopharm1.Based on 2019

196、 salesStrategic aspirations for 2025Commercial executionOur International Operations(IO)unit covers 190 countries and 95%of the worlds 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 No

197、vo 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 cr

198、eates 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

199、 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 o

200、f 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 approachTo ensure as many as possible of these people can access our treatments,we tailor

201、 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 insul

202、in 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.Ho

203、wever,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-ments agenda through general reform a

204、nd 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 trends across our geographic regions and therapeutic focus

205、 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

206、goals sustainably.Growing fast and sustainably2019 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 u

207、nmet medical needs Our market fit approach where our re-gional teams develop product strategies fit for their areas Our portfolio of productsLooking 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 t

208、he 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 be

209、nefiting 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.16Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo NordiskOur b

210、usinessNovo Nordisk diabetes value market share and share of growth in International Operations NN share of growth NN market share 0510152025Nov 201622.0%20.7%23.1%7.4%Nov 2019%Whilst we remain value leaders in the GLP-1 market,we are facing increased competitive pressures and a decline in our marke

211、t 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

212、.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,Ryb

213、elsus,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

214、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)t

215、o 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

216、 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

217、.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.Furthe

218、rmore,we are confident that an increasing number of patients living with haemophilia B will choose Refixia.Combining research and commercial innovationWe believe Rybelsus our semaglu-tide-based oral diabetes medicine will transform the lives of millions of people across IO by helping people to manag

219、e 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 products first IO launch.We are also capitalising on innovation developments in different regions.For example,in China,the governments push for innov

220、ation 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

221、 patients better manage their diabetes,we are working closely 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 doc

222、tors 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

223、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.17Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo NordiskOur businessCommercial execution

224、: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 potentia

225、l 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 j

226、ust 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.25The unmet needs are beyond question and have brought about new dynamics

227、 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 under

228、insured 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 companys overall g

229、oal 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 br

230、inging 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 gr

231、owth 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:Rybelsus,ou

232、r 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 i

233、n 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 a

234、s 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 worlds larg-est insulin producer through innovative injectable drugs.Going forward,we will transform the market with our i

235、ndus-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-v

236、ation;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

237、healthcare systemTackling the structural challenges in Strengthen Diabetes care leadership aim at a global value market share of more than 1/3 Strengthen Obesity care leader-ship and double current sales Secure a sustained growth outlook for Biopharm1.Based on 2019 salesStrategic aspirations for 202

238、5Commercial execution18Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo NordiskOur businessNovo Nordisk diabetes value market share and share of growth in North America Operations NN share of growth NN market share 01020304050Nov 201637.4%31.1%28.5%22.9%Nov 2019%In a

239、few years,Novo Nordisk USA aspire to havenew blockbusters on the marketnotably increase the number of patients treatedturned around approx.70%of sales(from 2015)2the US healthcare system calls for long-term reform changes to make sustainable and meaningful affordability a reality.We are doing our pa

240、rt 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 Le

241、ading a sustainable business.Advocating for stronger obesity focus and policiesWe 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,

242、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

243、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 s

244、pe-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 stakeholders to advocate for the Treat and Reduce Obesity Act,a vital piece of

245、 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

246、 living with obesity in the US to seek and receive the respectful,complete care they deserve.Promising prospects in biopharmHaemophilia 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

247、.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

248、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 2019.19Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo NordiskOur business Deliver s

249、olid 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 shareho

250、lders2.From 2015 to 2022Strategic aspirations for 2025FinancialsFinancials:2019 performance and 2020 outlookFinancial performanceNovo Nordisks 2019 performance for sales measured at constant exchange rates(CER)exceed the outlook provided in February 2019,while operating profit measured at CER was wi

251、thin 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 Feb

252、ruary 2019.Geographic sales developmentSales 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

253、 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 areasSales growth in 2019 was 9%measured in

254、 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 developmentSales in Diabetes care increased by 8%measured in Danish kroner and by 4

255、%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

256、 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 i

257、nde-pendent data provider IQVIA.InsulinSales 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

258、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,

259、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

260、 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,partly offset by declining NovoMix sales.Ryzodeg has now been launched in 30 countries.Sales of fast-acting insuli

261、n 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

262、 by declining sales of NovoRapid,partly offset by a positive impact from Fiasp.Fiasp has now been launched in 33 countries.Sales growth In DKK as reported At constant exchange rates%201520162017201820190510152025201520162017*2018*2019%020406080100*In 2017,North America contributed-5%to the total gro

263、wth*In 2018,Japan&Korea contributed-2%to the total growthShare of growth at constant exchange rates Region Europe Region AAMEO Region China Region Japan&Korea Region Latin America North America Operations 20Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo NordiskOur b

264、usinessSales 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.Sal

265、es 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 segments value share of the to-tal

266、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 mil

267、lion.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.BiopharmBiopharm,sales developmentSales of biopharm

268、 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 Ame

269、rica,Region AAMEO,Region China and Region Japan&Korea.HaemophiliaSales 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 i

270、ts 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 increas

271、ingly 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

272、 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 i

273、n 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

274、 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 marke

275、t 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 profitThe 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%me

276、asured 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 percen

277、tage 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 Sales by segment Biopharm Diabetes and Obesity care 20152016201720182019DKK billion0255075100125Operating profit Operating profit ma

278、rgin(left)Operating profit(right)20152016201720182019DKK billion%6050403020100010203040506021Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo NordiskOur businessdriven by International Operations reflect-ing resource allocation to growth markets and promotional activi

279、ties 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 o

280、ffset 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

281、 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 progra

282、mmes 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 Tr

283、esiba 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 m

284、illion 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 f

285、or operating profit growth measured at CER of 4-6%in 2019.Financial items(net)and taxFinancial 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

286、billion.In line with Novo Nordisks 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 develop

287、ment 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 20

288、19 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 t

289、he 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 flowCapital expenditure for property,plant and equipment was DKK 8.9 billion compared with DKK 9.6 billion in 201

290、8,which is in 20152016201720182019DKK billion010203040Free cash flowline 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 p

291、roduction facilities in Kalundborg,Denmark,expan-sion of production facilities in Chartres,France and a new diabetes filling capacity in Hillerd,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 incr

292、ease of 6%com-pared with 2018 primarily reflects increased cash from operating activities driven by the timing of rebate payments in the USA.Key invoicing currenciesImpact on Novo Nordisks operating profit in the next 12 months of a 5%movement in currencyHedging period(months)USDDKK 1,950 million9CN

293、Y1DKK 450 million7JPYDKK 150 million12CADDKK 130 million9GBPDKK 100 million101 Chinese yuan traded offshore(CNH)used as proxy when hedging Novo Nordisks CNY currency exposure22Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo NordiskOur businessFor 2020,sales growth is

294、 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 Espero

295、ct,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,e

296、specially 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

297、 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 activities related to the commercial priorities across the operating units including the introductio

298、n 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

299、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 foreig

300、n 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-pacit

301、y for active pharmaceutical ingredient(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,comp

302、ared 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 f

303、or 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

304、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 No

305、vo Nordisks operating profit as outlined in the table Key invoicing currencies.Long-term financial targetsNovo 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 recentl

306、y 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 asse

307、ts(OPAT/NOA)of 80%.Long-term financial targets2019201820172016Average 2016-2019TargetOperating profit growth at CER15.6%2.8%4.8%6.2%4.9%5%Operating profit after tax to net operating assets98.0%116.7%143.2%150.2%80%Cash to earnings88.4%84.2%85.5%105.4%Cash to earnings(three-year average)86.0%91.7%96.

308、4%102.4%85%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.Outlook 2020The current expectations for 2020 are sum

309、marised in the table below:Expectations are as reported,if not otherwise statedExpectations 5 February 2020Sales growthat CER3%to 6%as reportedAround 1 percentage point higher than at CEROperating profit growthat CER1%to 5%as reportedAround 1 percentage point higher than at CER Financial items(net)L

310、oss of around DKK 1.5 billionEffective tax rate20%to 22%Capital expenditure(PP&E)Around DKK 6.5 billionDepreciation,amortisation and impairment lossesAround DKK 5 billionFree cash flowDKK 36-41 billion23Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo NordiskOur busin

311、essStrategic aspirations for 2025To 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 Nordisks future growth outlook.Consequently,

312、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

313、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 Nordisks growth and investment opportu-nities across therapy areas and geographies.The strategic as

314、pirations are objectives that Novo Nordisk intends to work towards and are not a projection of Novo Nordisks 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 statementsNovo

315、 Nordisks 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 informati

316、on 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 c

317、onnection 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 Nordisks p

318、roducts,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 a

319、nd 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 ca

320、n 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

321、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 co

322、nditions,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-

323、driven price decreases for Novo Nordisks products,in-troduction of competing products,reliance on information technology,Novo Nordisks ability to successfully market current and new products,exposure to product liability and legal proceedings and investigations,changes in governmental laws and relat

324、ed 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,unexp

325、ected 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 Nordisks results or the accuracy of forward-looking statements in this Annual Report

326、 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 201

327、9,whether as a result of new information,future events or otherwise.24Novo Nordisk Annual Report 2019Consolidated statementsGovernanceIntroducing Novo NordiskOur businessResearch and development In 2019,we made significant prog-ress in research and development pipeline,reaching several important reg

328、ulatory 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 Diabetes careRegulator

329、y 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,

330、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

331、 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 s

332、tandard 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 additiona

333、l 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.Based on the