《諾和諾德Novo Nordisk(NVO)2024年20-F年度報告「NYSE」(英文版)(40頁).pdf》由會員分享,可在線閱讀,更多相關《諾和諾德Novo Nordisk(NVO)2024年20-F年度報告「NYSE」(英文版)(40頁).pdf(40頁珍藏版)》請在三個皮匠報告上搜索。
1、A Novo Nordisk employee receiving a tour of our active construction project at our site in Kalundborg,Denmark.This project is part of our investment of more than DKK 80 billion in new active pharmaceutical ingredient facilities.These significant expansions aim to scale up production of life-changing
2、 treatments,including GLP-1-based medicines,to benefit many more people living with serious chronic diseases.FORM 20-F 2024Novo Nordisk A/S Novo Alle 1,2880 Bagsvrd,Denmark CVR no.24256790 UNITED STATES SECURITIES AND EXCHANGE COMMISSIONWashington,D.C.20549FORM 20-F(Mark One)oREGISTRATION STATEMENT
3、PURSUANT TO SECTION 12(b)OR(g)OF THE SECURITIES EXCHANGE ACT OF 1934ORxANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December31,2024ORoTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934ORoSHELL COMPAN
4、Y REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934Commission File Number:333-82318NOVO NORDISK A/S(Exact name of Registrant as specified in its charter)Not applicableThe Kingdom of Denmark(Translation of Registrants name into English)(Jurisdiction of incorporation or orga
5、nization)Novo Alle 1DK-2880 BagsvrdDenmark(Address of principal executive offices)Karsten Munk KnudsenExecutive vice president and chief financial officerTel:+45 4444 8888E-mail:Novo Alle 1,DK-2880 Bagsvrd,Denmark(Name,Telephone,E-mail and Address of Company Contact Person)Securities registered or t
6、o be registered pursuant to Section 12(b)of the Act:Title of each class:Trading Symbol(s):Name of each exchange on which registered:B shares,nominal value DKK 0.10 eachNew York Stock Exchange*American Depositary Receipts,each representing one B ShareNVONew York Stock Exchange*Not for trading,but onl
7、y in connection with the registration of American Depositary Receipts,pursuant to the requirements of the Securities and Exchange Commission.Securities registered or to be registered pursuant to Section 12(g)of the Act:NoneSecurities for which there is a reporting obligation pursuant to Section 15(d
8、)of the Act:NoneIndicate the number of outstanding shares of each of the issuers classes of capital or common stock as of the close of the period covered by the Annual Report:A shares,nominal value DKK 0.10 each:1,074,872,000 B shares,nominal value DKK 0.10 each:3,390,128,000 Indicate by check mark
9、if the registrant is a well-known seasoned issuer,as defined in Rule 405 of the Securities Act.Yes x No oIf this report is an annual or transition report,indicate by check mark if the registrant is not required to file reports to Section 13 or 15(d)of the Securities Exchange Act of 1934.Yes o No xIn
10、dicate by check mark whether the Registrant(1)has filed all reports required to be filed by Section 13 or 15(d)of the Securities Exchange Act of 1934 during the preceding 12 months(or for such shorter period that the Registrant was required to file such reports),and(2)has been subject to such filing
11、 requirements for the past 90 days.Yes x No oIndicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T(232.405 of this chapter)during the preceding 12 months(or for such shorter period that t
12、he registrant was required to submit such files).Yes x No oIndicate by check mark whether the registrant is a large accelerated filer,an accelerated filer,a non-accelerated filer,or an emerging growth company.See definition of“large accelerated filer”,“accelerated filer”,and“emerging growth company”
13、in Rule 12b-2 of the Exchange Act.Large accelerated filer x Accelerated filer o Non-accelerated filer o Emerging growth company oIf an emerging growth company that prepares its financial statements in accordance with U.S.GAAP,indicate by check mark if the registrant has elected not to use the extend
14、ed transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a)of the Exchange Act.o The term“new or revised financial accounting standard”refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards
15、Codification after April 5,2012.Indicate by check mark whether the registrant has filed a report on and attestation to its managements assessment of the effectiveness of its internal control over financial reporting under Section 404(b)of the Sarbanes-Oxley Act(15 U.S.C.7262(b)by the registered publ
16、ic accounting firm that prepared or issued its audit report.xIf securities are registered pursuant to Section 12(b)of the Act,indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.
17、xIndicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive based compensation received by any of the registrants executive officers during the relevant recovery period pursuant to 240.10D-1(b).oIndicate by check mark which basis of
18、accounting the registrant has used to prepare the financial statements included in this filling:U.S.GAAP o International Financial Reporting Standards as issued by the International Accounting Standards Board x Other o If“Other”has been checked in response to the previous question,indicate by check
19、mark which financial statement item the registrant has elected to follow:Item 17 o Item 18 oIf this is an annual report,indicate by check mark whether the registrant is a shell company(as defined in Rule 12b-2 of the Exchange Act).Yes o No xTABLE OF CONTENTSINTRODUCTION2Part IITEM 1IDENTITY OF DIREC
20、TORS,SENIOR MANAGEMENT AND ADVISERS3ITEM 2OFFER STATISTICS AND EXPECTED TIMETABLE3ITEM 3KEY INFORMATION3ITEM 4INFORMATION ON THE COMPANY4ITEM 4AUNRESOLVED STAFF COMMENTS10ITEM 5OPERATING AND FINANCIAL REVIEW AND PROSPECTS10ITEM 6DIRECTORS,SENIOR MANAGEMENT AND EMPLOYEES15ITEM 7MAJOR SHAREHOLDERS AND
21、 RELATED PARTY TRANSACTIONS18ITEM 8FINANCIAL INFORMATION20ITEM 9THE OFFER AND LISTING20ITEM 10ADDITIONAL INFORMATION20ITEM 11QUALITATIVE AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISK23ITEM 12DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES24Part II ITEM 13DEFAULTS,DIVIDEND ARREARAGES AND DELI
22、NQUENCIES25ITEM 14MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS25ITEM 15CONTROLS AND PROCEDURES25ITEM 16AAUDIT COMMITTEE FINANCIAL EXPERT26ITEM 16BCODE OF ETHICS26ITEM 16CPRINCIPAL ACCOUNTANT FEES AND SERVICES26ITEM 16DEXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT CO
23、MMITTEES27ITEM 16EPURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS27ITEM 16FCHANGE IN REGISTRANTS CERTIFYING ACCOUNTANT28ITEM 16GCORPORATE GOVERNANCE28ITEM 16HMINE SAFETY DISCLOSURE30ITEM 16IDISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS30ITEM 16JINSIDER TR
24、ADING POLICIES30ITEM 16KCYBERSECURITY31Part III ITEM 17FINANCIAL STATEMENTS32ITEM 18FINANCIAL STATEMENTS32ITEM 19EXHIBITS36SIGNATURESSIGNATURES38TABLE OF CONTENTS1Novo Nordisk Form 20-F 2024INTRODUCTIONIn this Form 20-F the terms the Company,Novo Nordisk and the Group refer to the parent company Nov
25、o Nordisk A/S together with its consolidated subsidiaries.The term Novo Nordisk A/S is used when addressing matters specifically related to this legal entity.Pursuant to Rule 12b-23(a)of the Securities Exchange Act of 1934,as amended,certain information for the 2024 Form 20-F of Novo Nordisk A/S set
26、 out herein is being incorporated by reference from the Companys statutory Annual Report 2024,including the consolidated financial statements of Novo Nordisk A/S(hereafter the“Annual Report 2024”)and the Companys Remuneration Report 2024 as specified elsewhere in this Form 20-F(with the exception of
27、 the items and pages so specified,the Annual Report 2024 and Remuneration Report 2024 are not deemed to be filed as part of this Form 20-F).Therefore,the information in this Form 20-F should be read in conjunction with the Annual Report 2024 and the Remuneration Report 2024(see Exhibits 15.1 and 15.
28、3,respectively)Forward-looking statementsThe information set forth in this Form 20-F and in the items and pages so specified as incorporated herein by reference to Novo Nordisks statutory Annual Report 2024,contains certain forward-looking statements as the term is defined in the U.S.Private Securit
29、ies Litigation Reform Act of 1995.Forward-looking statements can be identified by the fact that they do not relate to historical or current facts and include guidance.Words such as believe,expect,may,will,plan,strategy,transition plan,prospect,foresee,estimate,project,anticipate,can,intend,target an
30、d other words and terms of similar meaning in connection with any discussion of future operating,financial or sustainability performance identify forward-looking statements.Examples of such forward-looking statements include,but are not limited to:Statements of targets,future guidance,(transition)pl
31、ans,objectives or goals for future operations,including those related to operating,financial and sustainability matters,Novo Nordisks products,product research,product development,product introductions and product approvals as well as cooperation in relation thereto;Statements containing projections
32、 of or targets for revenues,costs,income(or loss),earnings per share,capital expenditures,dividends,capital structure,net financials and other financial measures;Statements regarding future economic performance,future actions and outcome of contingencies such as legal proceedings;andStatements regar
33、ding the assumptions underlying or relating to such statements.These statements are based on current plans,estimates,opinions,views and projections.Although Novo Nordisk believes that the expectation reflected in such forward-looking statements are reasonable,there can be no assurance that such expe
34、ctation will prove to be correct.By their very nature,forward-looking statements involve risks,uncertainties,and assumptions,both general and specific,and actual results may differ materially from those contemplated,expressed or implied by any forward-looking statement.Factors that may affect future
35、 results include,but are not limited to,global as well as local political,economic and environmental conditions,such as interest rate and currency exchange rate fluctuations or climate change,delay or failure of projects related to research and/or development,unplanned loss of patents,interruptions
36、of supplies and production,including as a result of interruptions or delays affecting supply chains on which Novo Nordisk relies,shortages of supplies,including energy supplies,product recalls,unexpected contract breaches or terminations,government-mandated or market-driven price decreases for Novo
37、Nordisks products,introduction of competing products,reliance on information technology including the risk of cybersecurity breaches,Novo Nordisks ability to successfully market current and new products,exposure to product liability and legal proceedings and investigations,changes in governmental la
38、ws and related interpretation thereof,including on reimbursement,intellectual property protection and regulatory controls on testing,approval,manufacturing and marketing,and taxation changes,including changes in tariffs and duties,perceived or actual failure to adhere to ethical marketing practices,
39、investments in and divestitures of domestic and foreign companies,unexpected growth in costs and expenses,strikes and other labour market disputes,failure to recruit and retain the right employees,failure to maintain a culture of compliance,epidemics,pandemics or other public health crises,effects o
40、f domestic or international crises,civil unrest,war or other conflict,and factors related to the foregoing matters and other factors not specifically identified herein.For an overview of some,but not all,of the risks that could adversely affect Novo Nordisks results or the accuracy of forward-lookin
41、g statements in this document,reference is made to the overview of risk factors in Risks on pages 38-40 of our Annual Report 2024.Unless required by law,Novo Nordisk has no duty and undertakes no obligation to update or revise any forward-looking statement,whether as a result of new information,futu
42、re events or otherwise.Enforceability of civil liabilitiesThe Company is a Danish corporation and a majority of its directors and officers,as well as certain experts named herein,are non-residents of the United States.A substantial portion of the assets of Novo Nordisk A/S,its subsidiaries and such
43、persons are located outside the United States.As a result,it may be difficult for shareholders of the Company to effect service within the United States upon directors,officers and experts who are not residents of the United States or to enforce judgments in the United States.In addition,there can b
44、e no assurance as to the enforceability in Denmark against the Company or its respective directors,officers and experts who are not residents of the United States,or in actions for enforcement of judgments of United States courts,of liabilities predicated solely upon the federal securities laws of t
45、he United States.INTRODUCTION2Novo Nordisk Form 20-F 2024PART IITEM 1 IDENTITY OF DIRECTORS,SENIOR MANAGEMENT AND ADVISERSNot applicable.ITEM 2 OFFER STATISTICS AND EXPECTED TIMETABLENot applicable.ITEM 3 KEY INFORMATIONA.RESERVEDB.CAPITALIZATION AND INDEBTEDNESSNot applicable.C.REASONS FOR THE OFFE
46、R AND USE OF PROCEEDSNot applicable.D.RISK FACTORSFor information on risk factors,reference is made to Risks on pages 38-40 of our Annual Report 2024,excluding the section Mitigating actions on page 40.Outlined in greater detail below,we are subject to cybersecurity risks and the risk related to cli
47、mate change.The potential risk on our business as a result of cybersecurity breaches We rely on our IT systems to protect our intellectual property,business confidential information,and personal data.Therefore,disruption as a result of cybersecurity breaches could negatively impact the Companys busi
48、ness and operations or financial results.IT systems act as a backbone for the Company.They support processes in research&development,manufacturing,sales and supply,and business administration.As we are a global company,the size and complexity of our IT systems are significant,and our IT infrastructu
49、re and networks are spread across the geographic regions in which we operate.The dedicated cybersecurity teams who operate our global IT security infrastructure may be unable to respond sufficiently to the threats facing us or may fail to prevent service interruptions or security breaches resulting
50、from attacks by malicious third parties.Many of these cyber threats have the potential to cause significant downtime of critical IT systems or the unintended disclosure of confidential information and personal data.Although we have not previously experienced material losses as a result of such incid
51、ents,we cannot guarantee that we will be able to prevent similar incidents from occurring or adversely affecting our business in the future.We are subject to data privacy regulation in the EU(including the General Data Protection Regulation)and to privacy laws in many other jurisdictions where we do
52、 business that impose obligations and restrictions on the collection and use of personal data.In the ordinary course of the Companys business,it collects and stores personal data(including sensitive personal data)of patients,health care professionals,employees and other third parties.Many third-part
53、y vendors provide support services in relation to our business processes and require access to sensitive information(including personal data)in the course of their work.Such vendors could themselves be susceptible to cybersecurity or personal data breaches.Any unauthorized access,disclosure,or other
54、 loss of personal data could result in legal claims or proceedings,liability under laws that protect the privacy of personal information,and significant regulatory penalties,disrupt the Companys operations and damage the Companys reputation.The potential risk on our business as a result of failure t
55、o meet regulatory or ethical expectations on environmental impact,including climate changeClimate change has global implications and poses a significant threat to human health and development.Companies are increasingly expected to behave in a responsible manner on a variety of environmental matters,
56、by governmental and regulatory authorities,counterparties,such as vendors and suppliers,customers and investors.In particular,we recognize the environmental issues related to the pharmaceutical industry.ITEM 1 IDENTITY OF DIRECTORS,SENIOR MANAGEMENT AND ADVISORS3Novo Nordisk Form 20-F 2024At Novo No
57、rdisk,climate-related risks are identified and assessed through our risk management process.The risk assessment includes a natural hazards risk rating of supplier locations,provided by external insurance companies.The risk rating is related to various parameters,including natural events such as floo
58、ding,earthquakes,high-speed winds,tornados,hail storms,and lightning.The risk assessment serves to provide input for risk mitigation,and consequently prioritize actions to prevent or minimize the impact of supply disruptions on manufacturing.The Companys main production facilities are located in Den
59、mark,where the risk of natural events is assessed lower;however,the Company also has other production facilities in countries that are at greater risk of natural disasters.For example,our production facility in Koriyama,Japan is exposed to a higher risk of earthquakes,our production facility in Tian
60、jin,China is located in an area prone to storm surges due to rising sea levels and our production facilities in North Carolina,United States and Bloomington,Indiana,United States are exposed to a higher risk of tornadoes and subsequent rainfall and lightening.In addition,availability of high-quality
61、 water is essential for the production of diabetes and biopharmaceutical products and hence the Companys operations.The Company has production facilities in countries with high water stress levels,such as China,the United States(Clayton and Durham,North Carolina),Iran and Algeria(Blida).Despite our
62、commitment to identify climate-related risks,we could be unable to meet our environmental objectives in an efficient and timely manner,or at all.Our CO2e emissions continue to rise as the company grows,in particular within scope 3 emissions,which account for approximately 95%of our emissions.To miti
63、gate our contribution to climate change,Novo Nordisk is committed to reaching net zero emissions across scope 1,scope 2(market-based)and scope 3 emissions by 2045.In addition,we have targets of zero scope 1 and scope 2(market-based)CO2e emissions by 2030 and a new target of 33%absolute reduction of
64、scope 3 emissions by 2033 compared to our base-year of 2024(covering two-thirds of our scope 3 emissions).Key decarbonization levers include converting to lower carbon materials,requiring that our tier 1 suppliers convert to renewable energy,and lowering the emissions from our distribution.Factors t
65、hat may inhibit our ability to reach these targets or failure to maximize our environmental sustainability credentials could expose us to increased regulatory risk and put us at a commercial disadvantage relative to our peers.This could result in a material adverse effect on our business,financial c
66、ondition,results of operations and prospects and lead to reputational damage.ITEM 4 INFORMATION ON THE COMPANYA.HISTORY AND DEVELOPMENT OF THE COMPANYNovo Nordisk A/S was formed in 1989 by a merger of two Danish companies,Nordisk Gentofte A/S and Novo Industri A/S.Novo Industri A/S was the continuin
67、g company and its name was changed to Novo Nordisk A/S.The business activities of Nordisk Gentofte were established in 1923 by August Krogh,H.C.Hagedorn and A.Kongsted,and the business activities of Novo Industri A/S were established in 1925 by Harald and Thorvald Pedersen.From the beginning,the bus
68、iness of both companies was the production and sale of insulin for the treatment of diabetes.Novo Nordisks B shares are listed on Nasdaq Copenhagen(NOVO-B).Its ADRs are listed on the New York Stock Exchange(NVO).Legal name:Novo Nordisk A/SCommercial name:Novo NordiskDate of incorporation:November 28
69、,1931Legal form of the Company:A Danish public limited liability companyLegislation under which the Company operates:Danish lawCountry of incorporation:DenmarkReference is made to More information,on page 146 of our Annual Report 2024 for information on domicile.Important events in 2024 Reference is
70、 made to Introducing Novo Nordisk,pages 4-10 and 2024 performance and 2025 outlook,pages 32-37 of our Annual Report 2024 for a description of important events in 2024.ITEM 3 KEY INFORMATION4Novo Nordisk Form 20-F 2024Capital expenditure in 2024,2023 and 2022 For capital expenditure in 2024,2023 and
71、2022,reference is made to the section entitled Cash flow and capital allocation on page 34 of our Annual Report 2024.No significant divestments took place in the period from 20222024.For capital expenditures expected in 2025,reference is made to pages 34-35 in the subsection 2025 outlook in our Annu
72、al Report 2024.Such expenditures are expected to be financed with cash flow from operating activities.Public takeover offers in respect of the Companys sharesNo such offers occurred during 2024 or 2025 to date.B.BUSINESS OVERVIEWReference is made to the sections Key figures on page 7,Purpose and str
73、ategy on page 8 and Strategic Aspirations on pages 11-31 of our Annual Report 2024.Novo Nordisk is a global healthcare company and a world leader in Diabetes and Obesity care.The Company manufactures and markets pharmaceutical products and services that make a significant difference to patients,the
74、medical profession and society.Headquartered in Denmark,Novo Nordisk employs more than 75,000 employees in 80 countries,and markets its products in approximately 170 countries.The Company has a broad product portfolio across Diabetes and Obesity care and Rare disease,including a portfolio of glucago
75、n-like-peptide-1(GLP-1)receptor agonists for the treatment of diabetes and obesity,modern insulins and human insulins.During 2024,there has been continued strong growth across therapy areas and geographic areas in which Novo Nordisk operates.High demand during 2024 has led to periodic supply constra
76、ints for certain products in some markets,including the leading product by sales,Ozempic for the treatment of type 2 diabetes1.The Company also markets two drugs-Saxenda and Wegovy-for the treatment of obesity.In its fourth year after launch the GLP-1 product,Wegovy revenue,grew 86%to DKK 58 billion
77、.Further,Novo Nordisk has a Rare disease portfolio consisting mainly of growth hormone and haemophilia products.On December 18,2024,Novo Nordisk acquired three fill-finish sites from Novo Holdings A/S in connection with a transaction where Novo Holdings A/S acquired Catalent,Inc.(“Catalent”),a globa
78、l contract development and manufacturing organisation.The acquisition of the fill-finish sites is aligned with Novo Nordisks strategy of reaching more people living with diabetes and obesity with current and future treatments.It is expected to enable an expansion of the manufacturing capacity and pr
79、ovide future optionality and flexibility for Novo Nordisks existing supply network.The acquisition is expected to gradually increase Novo Nordisks filling and finish capacity.The purchase price of the three sites totalled USD 11.7 billion,which was mainly debt-financed.Segment informationNovo Nordis
80、k is engaged in the discovery,development,manufacturing and marketing of pharmaceutical products and has two business segments:(i)Diabetes and Obesity care and(ii)Rare disease.Reference is made to Note 2.2 Segment information in the consolidated financial statements in our Annual Report 2024.Seasona
81、litySales of individual products in individual markets may be subject to fluctuations from quarter to quarter.However,the Companys consolidated operating results have not been subject to significant seasonality.Raw materialsThe impact on the overall profitability of Novo Nordisk from variations in r
82、aw material prices is unlikely to be significant.Currently,there is no raw material supply shortage that is expected to significantly impact the Companys ability to supply any significant market.Regarding the 2024 supply constraints,reference is made to page 26 of the Annual Report 2024.The supply s
83、ituation has significantly improved for 2025.Market and competitionNovo Nordisks insulin and other pharmaceutical products are marketed and distributed through subsidiaries,distributors and independent agents each responsible for specific geographic areas.The Companys financial reporting is divided
84、into:EMEA(covering Europe,the Middle East and Africa),Region China(covering Mainland China,Hong Kong and Taiwan),Rest of World(covering all other ITEM 4 INFORMATION ON THE COMPANY5Novo Nordisk Form 20-F 20241 Product indications described in this Form 20-F are composite summaries of the major indica
85、tions approved in the products principal markets.Not all indications are necessarily available in each of the markets in which the products are approved.The summaries presented herein for the purpose of financial reporting do not substitute for careful consideration of the full labelling approved in
86、 each market.countries except for North America)and North America(covering the United States and Canada).For 2024,the Companys most important markets in terms of sales were the United States,China,Canada,Japan,and the major European countries.Due to the increasing number of people with diabetes,the
87、global pharmaceutical market for treatment of diabetes continues to grow.Several of the major international pharmaceutical companies have entered the diabetes market,specifically in the area of oral products for the treatment of type 2 diabetes.In the global diabetes market,Novo Nordisk and Eli Lill
88、y are the most significant companies measured by market share.The market for anti-obesity medications,primarily GLP-1s,continues to grow and expand,driven by innovative treatments coming to the market and the significant unmet medical need for safe and efficacious treatment options.Novo Nordisk and
89、Eli Lilly are the most significant companies measured by market share,but several major international pharmaceutical companies and smaller biotech companies have anti-obesity medications under development.The use of GLP-1 as a treatment option for people with type 2 diabetes has continued to increas
90、e resulting in significant growth of the GLP-1 market.Novo Nordisk and Eli Lilly are the most significant companies in the global GLP-1 market measured by market share.In February 2018,Novo Nordisk launched the once-weekly GLP-1 product,Ozempic,for the treatment of adults with type 2 diabetes in the
91、 United States and Canada.Since then,Ozempic has become a market leading product and the Companys best performing product by sales,with global sales of more than DKK 120 billion in 2024.The global branded obesity market almost doubled by volume in 2024.Wegovy has been launched in the United States a
92、nd more than 15 other countries outside the United States.Market conditions within the pharmaceutical industry continue to change,including efforts by both private and governmental entities to reduce or control costs generally and in specific therapeutic areas.Most of the countries in which Novo Nor
93、disk sells insulin and GLP-1 subsidize or control pricing.In most markets insulin and GLP-1 products are prescription drugs.In recent years,there has been a general trend in the United States of payers managing the cost of diabetes care to exert pressure on the price of Novo Nordisks and competitors
94、 products.In spite of this external pressure,Novo Nordisk has maintained a leading position in the overall diabetes care market through the quality and innovation-driven value of the Companys Diabetes care products.In the United States,pharmacy benefit managers and managed care organizations have co
95、ntinued to leverage their increasing size and control to demand higher rebates which has impacted the net realized prices.Furthermore,competition has intensified,including the authorization of the first interchangeable insulin in 2021,contributing to a downward pressure on manufacturers net prices.P
96、atentsTo maintain and expand competitiveness,Novo Nordisk strives for the strongest possible protection for those inventions that are created during the development of new products.Novo Nordisk anticipates that the expiration of certain patents could impact sales within the coming years.However,thro
97、ugh continued investments in research and development,Novo Nordisk strives to bring novel and innovative products to the market and thereby sustain strong patent protection in the future,as new generations of products replace currently marketed products.For patent information on all Novo Nordisks ma
98、rketed products,reference is made to the section Patent status for products with marketing authorisation on page 25 in our Annual Report 2024.For key products with recent patent expiration or with patent expiration occurring within the coming years,geographic sales splits are provided and factors th
99、at may influence the potential impact of competitive product launches are discussed.Sales of key products with recent or upcoming patent expiration:Total sales in 2024(in DKKmillion)North America OperationsHereofInternationalOperationsHereofProductUSAEMEARegion ChinaRest of WorldVictoza 5,482 1,796
100、1,699 3,686 1,422 975 1,289 Saxenda 6,940 1,377 777 5,563 2,920 102 2,541 ITEM 4 INFORMATION ON THE COMPANY6Novo Nordisk Form 20-F 2024Patent situation of key Diabetes and Obesity care productsToday,biosimilar and/or interchangeable versions of insulin can be approved in the United States via the 35
101、1(k)pathway.In the EU,a biosimilar pathway and guidelines are available for insulins,and the guideline for biosimilar products issued in Japan is also relevant for insulin.A biosimilar to NovoRapid/NovoLog produced by a competitor was launched in 2020.An interchangeable biosimilar for NovoRapid/Novo
102、Log produced by a competitor was approved in July 2021.Furthermore,biosimilar insulins are being developed in China by local competitors.The total sales of Victoza were DKK 5,482 million in 2024(DKK 8,664 million in 2023).The compound patents for Victoza have expired.In Japan,the drug compound paten
103、t expired in 2022;in the U.S.and Germany,the drug compound patent expired in 2023.The drug compound patent expired in China in 2017 and in 2023 a biosimilar version of Victoza was approved in China.Novo Nordisk has received notifications from several manufacturers that they have filed Abbreviated Ne
104、w Drug Applications(ANDAs)for generic versions of Victoza,Saxenda,Ozempic,Wegovy,and Rybelsus,respectively.The ANDAs contain Paragraph IV certifications to obtain approval to engage in the commercial manufacture,use or sale of such products before the expiration of some or all of the patents current
105、ly listed for those products in the Orange Book.Novo Nordisk filed complaints for patent infringement against these manufacturers.Novo Nordisk has entered into settlement agreements with several manufacturers that have filed ANDAs for Victoza.Consequently,these manufacturers were licensed to launch
106、a generic version of Victoza as of June 22,2024.Teva launched an authorized generic version of Victoza in June,2024,and Hikma Pharmaceuticals PLC launched its generic liraglutide product in December 2024.Moreover,Novo Nordisk has entered into settlement agreements regarding the U.S.patent litigation
107、 matters for Saxenda.Novo Nordisk has now also entered into settlement agreements with Alvogen Inc.(Alvogen),Rio Biopharmaceuticals Inc.(Rio),Sun Pharmaceutical Industries Limited(Sun),Dr.Reddys Laboratories,Ltd.(DRL),Mylan Pharmaceuticals Inc.(Mylan),Zydus Pharmaceuticals Inc.(Zydus)and Apotex Inc.
108、(Apotex)regarding the U.S.patent litigation for Ozempic.All terms of the agreements are confidential.All agreements are subject to review by the U.S.Federal Trade Commission and the U.S.Department of Justice.In March 2023,Mylan filed an IPR challenging the validity of a patent which claims a method
109、of treating type 2 diabetes using 1 mg of semaglutide,and the Patent Trial and Appeal Board instituted an IPR proceeding.After the institution decision,Sun,DRL,and Apotex moved to join the IPR and those motions were granted.In October 2024,Novo Nordisk settled with Mylan,Sun,DRL,and Apotex prior to
110、the IPR hearing.All terms of the agreements are confidential.All agreements are subject to review by the U.S.Federal Trade Commission and the U.S.Department of Justice.In China,the semaglutide compound patent was subject to invalidation actions and was upheld by the Beijing IP Court in November 2023
111、.This decision has been appealed to the Supreme Peoples Court where the case is currently pending.Novo Nordisk will continue to defend its intellectual property associated with liraglutide and semaglutide,including through litigation.The total sales of obesity care products(Saxenda and Wegovy)were D
112、KK 65,146 million in 2024(DKK 41,632 million in 2023),of which the majority of the sales comes from Wegovy.The drug compound patent for Saxenda(liraglutide)has expired in all countries.Compound patent expiry in the U.S.for the semaglutide branded products-Ozempic,Rybelsus,and Wegovy-is 2032.For addi
113、tional information,reference is made to the section Patent status for products with marketing authorisation on page 25 of our Annual Report 2024.Impact of regulationAs a pharmaceutical company,Novo Nordisk depends on government approvals related to production,development,marketing and reimbursement
114、of its products.Important regulatory bodies include the U.S.Food and Drug Administration,the European Medicines Agency,Chinas National Medical Products Administration and the Japanese Ministry of Health,Labour and Welfare.Treatment guidelines from non-governmental organizations such as the European
115、Association for the Study of Diabetes and the American Diabetes Association may also impact the Company.Disclosure pursuant to Section 219 of the Iran Threat Reduction and Syria Human Rights Act of 2012Pursuant to Section 13(r)of the Securities Exchange Act of 1934(Section 13(r),Novo Nordisk is obli
116、ged to disclose if,during 2024,it or any of its affiliates have engaged in certain Iran-related activities or transactions with persons designated under Executive Order 13224 or Executive Order 13382 dealt with the Government of Iran(“GOI”).Novo Nordisk conducts limited business relating to pharmace
117、utical products and devices within the Diabetes care and Rare disease business segments in Iran,which is permitted under ITEM 4 INFORMATION ON THE COMPANY7Novo Nordisk Form 20-F 2024the U.S.sanctions against Iran.Set forth below is a description of the activities and transactions by Novo Nordisks su
118、bsidiaries that are required to be disclosed pursuant to Section 13(r).Novo Nordisks U.S.subsidiaries and U.S.person employees are not involved in any of Novo Nordisks activities in Iran.However,the United States maintains broad exceptions that permit the commercial sale and export of medicine and m
119、edical devices to Iran or the Government of Iran.Similar exceptions,like those encompassed in section 11 of Executive Order 13902,are also in place for the manufacturing of medicine and medical devices for use in Iran.Novo Nordisk Pars(“NN Pars”),a wholly-owned subsidiary of Novo Nordisk A/S located
120、 in Iran,contracts with a number of companies that may be owned or controlled by the GOI to distribute its products.NN Pars also sponsors educational programs and congresses organized by GOI-controlled medical universities,and hosts and/or engages as scientific delegates or lecturers/speakers health
121、 care professionals employed by these medical universities at similar programs in Iran and other locations.Additionally,NN Pars makes donations to GOI-controlled public health organizations focusing on diabetes awareness and policy.NN Pars receives payments from,and makes payments to,Iranian banks(s
122、ome of which may be GOI-owned or controlled)relating to the sales of pharmaceutical products and devices.NN Pars makes payments incidental to its ordinary business activities to Iranian government entities and entities that are or may be GOI-owned or controlled,such as taxes,customs fees,insurance,p
123、roduct registration fees and telecommunications services expenses.In 2016,NN Pars purchased land from a GOI-owned or controlled holding company in order to construct a manufacturing facility in Iran.The facility opened and officially started production in August 2020 and is being used for assembly a
124、nd packaging of insulin pens for use in Iran.NN Pars purchases utility services from a GOI-owned or controlled entity.Novo Nordisks gross revenue related to transactions with GOI-owned or controlled entities in 2024 was not in excess of 1%of Group sales.Novo Nordisk does not allocate its net profit
125、on a country-by-country or activity-by-activity basis,other than as set forth in Novo Nordisks consolidated financial statements prepared in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board(IASB);however,Novo Nordisk estimates that its net profit at
126、tributable to the transactions with the GOI discussed above would not exceed a de minimis percentage of the Groups total net profit in 2024.The purpose of Novo Nordisks Iran-related activities is to provide access to important and essential pharmaceutical products such as insulin and haemophilia pro
127、ducts to patients in Iran,and to improve the healthcare of the Iranian people in accordance with Novo Nordisks access to care strategy.For that purpose,and because Novo Nordisk has determined that its activities comply with all applicable laws,Novo Nordisk intends to continue these activities(includ
128、ing local production of these products in Iran).C.ORGANIZATIONAL STRUCTURE For information regarding the organizational structure and securities exchange listings of Novo Nordisk A/S,the controlling shareholder Novo Holdings A/S and the Novo Nordisk Foundation and the ownership structure of Novo Nor
129、disk A/S,reference is made to the sections Corporate Governance on pages 16 and Shares and capital structure on pages 36-37 of our Annual Report 2024.Companies in the Novo Nordisk Group are listed in the section Companies in the Novo Nordisk Group on page 133 of our Annual Report 2024.D.PROPERTY,PLA
130、NTS AND EQUIPMENTThe Company has its headquarters in Bagsvrd,Denmark,where it occupies a number of buildings.Sales growth in 2024 has resulted in periodic supply constraints and related drug shortage notifications across a number of products and geographies.Following higher than expected volume grow
131、th in recent years,including GLP-1-based products such as Ozempic and Wegovy,combined with the expectation of continued volume growth and capacity limitations at some manufacturing sites,the 2025 outlook also reflects expected continued periodic supply constraints and related drug shortage notificat
132、ions across a number of products and geographies.Novo Nordisk is investing in internal and external capacity to increase supply both short and long term.The supply capacity is gradually increased,including the capacity for meeting growing demand in the future for our main products,Awiqli,Fiasp,Levem
133、ir,Norditropin NovoLog/NovoRapid,NovoLog Mix/NovoMix,NovoSeven,Ozempic,Rybelsus,Ryzodeg,Saxenda,Tresiba,Victoza,Wegovy and Xultophy.Reference is made to the sections Capital expenditures in 2024,2023 and 2022 under Item 4 for more information about the current expansion programs.For the nature of th
134、e Companys property,plant and equipment,as of December 31,2024 and 2023,reference is made to Note 3.2 Property,plant and equipment in the consolidated financial statements in our Annual Report 2024.ITEM 4 INFORMATION ON THE COMPANY8Novo Nordisk Form 20-F 2024The major production facilities owned by
135、the Company are located at a number of sites in Denmark,and internationally in the United States,France,China and Brazil.There are no material encumbrances on the properties;however,the facilities in Tianjin,China are constructed on land where the remaining term of the leases is 29 and 33 years.Acti
136、ve pharmaceutical ingredient(API)production is located in Denmark,primarily in Kalundborg and with secondary locations in Hillerd and Gentofte,both in Denmark,as well as in New Hampshire and North Carolina,United States,respectively.The following table sets forth certain information regarding our ma
137、jor production sites.MAJOR PRODUCTION FACILITIESSize of production area(square meters)Major Production ActivitiesKalundborg,Denmark168,300Active pharmaceutical ingredients for diabetes and obesity as well as products for Diabetes careActive pharmaceutical ingredients for haemophilia.Products for Rar
138、e diseaseHillerd,Denmark156,900Durable devices and components for disposable devicesProducts for diabetes and obesityActive pharmaceutical ingredients for haemophiliaBagsvrd,Denmark111,200Products for diabetes and obesityClayton,North Carolina,United States89,000Active pharmaceutical ingredients for
139、 diabetes and obesity(purification)Products for diabetes and obesityGentofte,Denmark70,800Active pharmaceutical ingredients for glucagon and growth hormone therapyProducts for growth hormone therapy,glucagon and haemophiliaTianjin,China67,200Products for diabetesProduction of durable devicesMlv,Denm
140、ark60,900Products for hormone replacement therapyProducts for oral antidiabetic treatmentProducts for oral diabetes treatmentChartres,France58,700Products for diabetesMontes Claros,Brazil56,200Products for diabetesGel production for active pharmaceutical ingredientsAnagni,Italy40,400Products for dia
141、betes and obesityContract manufacturing organization(CMO)related activitiesBrussels,Belgium18,000Products for diabetes and obesityCMO related activitiesBloomington,Indiana,United States13,100Products for diabetes and obesityCMO related activitiesIn December 2021,the Company announced the investment
142、in construction of a new purification facility and a new recovery facility as well as rebuilding of one existing fermentation facility at the production site in Kalundborg,Denmark.The investment will establish additional capacity for manufacturing active pharmaceutical ingredients.The facilities are
143、 expected to increase the production area with approximately 59,900 square meters.The facilities are expected to be operational during 2027 and the expected amount of expenditures is DKK 19.5 billion with realized spend of DKK 16.5 billion as of December 31,2024.The facilities will be financed by ca
144、sh flow from operating activities.In June 2022,the Company announced its investment in an expansion of an existing facility at the production site in Hjrring,Denmark.The investment will increase the capacity for production of NovoFine Plus needles and is expected to increase the production area by 5
145、,900 square meters.The expansion is expected to be finalized during 2025.The expected amount of expenditures is approximately DKK 550 million with realized spend of DKK 473 million as of December 31,2024.The expansion will be financed by cash flow from operating activities.In November 2022,the Compa
146、ny announced its investment in the expansion of its clinical manufacturing facilities in Bagsvrd,Denmark.The investment will establish additional capacity in R&D for the manufacturing of active pharmaceutical ingredients to supply the Companys global clinical trials.The expansion is expected to incr
147、ease the production area with 7,000 square meters and it is expected to be finalized in 2026.The expected amount of expenditures is DKK 7.4 billion with realized spend of DKK 7.0 billion as of December 31,2024.The expansion will be financed by cash flow from operating activities.ITEM 4 INFORMATION O
148、N THE COMPANY9Novo Nordisk Form 20-F 2024In June 2023,the Company announced its investment in expanding an existing API production facility in Hillerd,Denmark.The facility is expected to be operational during 2028 and its production area expected to be 65,000 square meters.The expected amount of exp
149、enditures for this facility is approximately DKK 15.9 billion with realized spend of DKK 6.2 billion as of December 31,2024.The facility will be financed by cash flow from operating activities.In November 2023,the Company announced its investment in the expansion of its API production facility in Ka
150、lundborg,Denmark.The facility is expected to be fully operational during 2029 and its production area expected to be 170,000 square meters.The expected amount of expenditures for this facility is approximately DKK 42.4 billion with realized spend of DKK 11.0 billion as of December 31,2024.The facili
151、ty will be financed by cash flow from operating activities.In November 2023,the Company announced the investment in an expansion of an existing facility at the production site in Chartres,France.The investment will significantly increase the capacity of the manufacturing site,adding aseptic producti
152、on and finished production processes and an extension of the current Quality Control Laboratory.The facility is expected to be gradually finalized from 2026 to 2028 and its production area expected to be 51,100 square meters.The expected amount of expenditures for this facility is approximately DKK
153、16.9 billion with realized spend of DKK 3.8 billion as of December 31,2024.The facility will be financed by cash flow from operating activities.In March 2024,the Company announced the investment in an expansion of an existing facility at the production site in Tianjin,China.The investment will signi
154、ficantly increase the capacity of the manufacturing site,adding aseptic production.The facility is expected to be fully operational during 2028 and its production area expected to be 25,000 square meters.The expected amount of expenditures for this facility is approximately DKK 4.1 billion with real
155、ized spend of DKK 1.1 billion as of December 31,2024.The facility will be financed by cash flow from operating activities.In June 2024,the Company announced the investment in an expansion of an existing facility at the production site in the U.S.in Clayton,North Carolina.The investment will signific
156、antly increase the capacity of the manufacturing site,adding aseptic production and finished production processes.The facility is expected to be fully operational during 2029 and its production area is expected to be 130,000 square meters.The expected amount of expenditures for this facility is appr
157、oximately DKK 27.0 billion with realized spend of DKK 5.1 billion as of December 31,2024.The facility will be financed by cash flow from operating activities.In November 2024,the Company announced the investment in an expansion of an existing facility at the production site in Hillerd,Denmark.The in
158、vestment will significantly increase the capacity of QC facilities.The facility is expected to be fully operational during 2027 and its production area is expected to be 53,000 square meters.The expected amount of expenditures for this facility is approximately DKK 2.9 billion with realized spend of
159、 DKK 0.3 billion as of December 31,2024.The facility will be financed by cash flow from operating activities.In December 2024,the Company announced the investment of a newly established facility in Odense,Denmark.The investment will significantly increase the capacity of the manufacturing site,addin
160、g aseptic production and finished production processes.The facility is expected to be fully operational during 2027 and its production area is expected to be 40,000 square meters.The expected amount of expenditures for this facility is approximately DKK 8.5 billion with realized spend of DKK 1.2 bil
161、lion as of December 31,2024.The facility will be financed by cash flow from operating activities.ITEM 4A UNRESOLVED STAFF COMMENTSNone.ITEM 5 OPERATING AND FINANCIAL REVIEW AND PROSPECTSNew accounting pronouncementsReference is made to Note 1.2 Changes in accounting policies and disclosures in the c
162、onsolidated financial statements in our Annual Report 2024.A.OPERATING RESULTSReference is made to the section Forward-looking statements on page 35-36 of our Annual Report 2024 and the discussion under the caption Risk factors under Item 3 of this Form 20-F.Further reference is made to Risks on pag
163、es 38-40 of our Annual Report 2024.The information in this section is based on our Annual Report 2024 and should be read in conjunction with such report.The analysis and discussion included in such report is primarily based on the Companys consolidated financial statements which are prepared in acco
164、rdance with IFRS Accounting Standards as issued by the International Accounting Standards Board.ITEM 4 INFORMATION ON THE COMPANY10Novo Nordisk Form 20-F 20242024 compared with 2023 The following portions of our Annual Report 2024 constitute the Board of Directors and Executive Managements discussio
165、n and analysis of results of operations(incorporated herein by reference):Introducing Novo Nordisk(pages 4-10)and 2024 performance and 2025 outlook(pages 32-37).2023 compared with 2022 For a discussion of our results of operations for 2023 compared with 2022,see Item 5.A.Operating Results,2023 Compa
166、red with 2022 included in our 2023 Annual Report on Form 20-F(File No.333-82318)filed with the SEC on January 31,2024(hereafter Annual Report 2023).Segment informationReference is made to Note 2.2 Segment information in the consolidated financial statements in our Annual Report 2024 for details on s
167、egmented results.Sales in Russia and Ukraine constituted less than 1%of Novo Nordisks global sales in 2024.Novo Nordisks factory in Russia is still operating to supply insulin to patients in Russia only.While Novo Nordisk maintains supply of medicine in Russia to ensure that more than 700,000 patien
168、ts can continue their treatment with essential medication.Novo Nordisk has ceased filing for marketing authorizations of new medication and has suspended further clinical investments in Russia.Novo Nordisk has to the extent possible continued supply of medicines in Ukraine and Novo Nordisk medicines
169、 are currently available in more than 90%of Ukraine.Foreign currenciesReference is made to Note 4.4 Financial risks in the consolidated financial statements in our Annual Report 2024 and for further description of foreign currency exposure and hedging activities,reference is made to the description
170、of financial instruments in Note 4.5 Derivative financial instruments in the consolidated financial statements in our Annual Report 2024.Governmental policiesPlease refer to pages 11-37 Strategic Aspirations of our Annual Report 2024 and Item 4 hereof.Off-balance sheet arrangementsReference is made
171、to Note 4.4 Financial risks in the consolidated financial statements and Note 5.2 Commitments in the consolidated financial statements in our Annual Report 2024.B.LIQUIDITY AND CAPITAL RESOURCESNovo Nordisk maintains a centralized approach to the management of the Groups financial risks.The overall
172、objectives and policies for Novo Nordisks financial risk management are outlined in the Novo Nordisk Treasury Policy,which is approved by the Board of Directors.The Treasury Policy governs the Groups use of financial instruments.For further information,reference is made to Item 11.Financial resource
173、sReference is made to Cash flow statement on page 103 and Balance sheet on page 104 of our Annual Report 2024.In addition,Novo Nordisk has obtained a credit rating from two independent external rating agencies.Novo Nordisk believes its financial resources are sufficient to meet its requirements for
174、at least the next 12 months.Cash flow in 2024,2023 and 2022 Reference is made to Cash flow statement on page 103 of our Annual Report 2024.The most significant source of cash flow from operating activities is sales of Diabetes and Obesity care and Rare disease products.Generally,other factors that a
175、ffect operating earnings,such as pricing,volume,product mix,costs and exchange rates,also have an impact on realized cash flow from operating activities.Except as disclosed in Note 4.8 Financial assets and liabilities in the consolidated financial statements in our Annual Report 2024,there are no ma
176、terial restrictions on the ability of subsidiaries with material cash amounts to transfer funds to the parent company,Novo Nordisk A/S.Trade receivable programTrade receivable program,as of December 31,2024,2023 and 2022,respectively,are shown in Note 4.4 Financial risks in the consolidated financia
177、l statements in our Annual Report 2024.ITEM 5 OPERATING AND FINANCIAL REVIEW AND PROSPECTS11Novo Nordisk Form 20-F 2024Debt financingReference is made to Balance sheet on page 104 and to Note 4.6 Borrowings in the consolidated financial statements in our Annual Report 2024 for information on Current
178、 and Non-current debt.Derivative financial instrumentsNovo Nordisk only hedges commercial exposures,including selected business development activities(mergers and acquisitions),and consequently does not enter into derivative transactions for trading or speculative purposes.Currency hedging is done w
179、ith foreign exchange forwards and foreign exchange options.Reference is made to Note 4.4 Financial risks and Note 4.5 Derivative financial instruments in the consolidated financial statements in our Annual Report 2024 for further information on financial instruments including currency exposure.Commi
180、tments for capital expenditure etc.Contractual obligations for capital expenditure and other contingent liabilities as of December31,2024 and 2023,respectively,are shown in Note 5.2 Commitments in the consolidated financial statements in our Annual Report 2024.The Executive Management of the Group b
181、elieves that the obligations are covered by the Groups financial resources as well as expected future cash flows from operating activities.C.RESEARCH AND DEVELOPMENT,PATENTS AND LICENSES,ETC.Novo Nordisk research and development is mainly focused on:Insulins,GLP-1s and other therapeutic compounds fo
182、r diabetes treatmentGLP-1s,combinations and other modes of action for obesity careBlood-clotting factors and other modes of action for treatment of haemophilia and other rare blood disordersHuman growth hormone and other modes of action for treatment of growth disorders and other rare endocrine diso
183、rdersNew indications with existing assets and other modes of action for treatment of cardiovascular diseases,MASH and other serious chronic diseasesResearch technology platforms including cell therapy and RNAi for treatment of diseases within Diabetes,Obesity,Rare disease and Cardiovascular&Emerging
184、 Therapy AreasThe research activities mainly utilise biotechnological methods based on advanced protein chemistry and protein engineering.These methods have played a key role in the development of the production technology used to manufacture insulin,GLP-1,recombinant blood-clotting factors and huma
185、n growth hormone.Research activities further utilise technology platforms including stem cells,gene therapy and RNAi therapies.Research and development activities are carried out by Novo Nordisks research and development centres,mainly in Denmark,the United States(U.S.),the United Kingdom and China.
186、Clinical trials are carried out all over the world.Novo Nordisk also enters into partnerships and licence agreements.Reference is made to Note 2.3 Research and development costs in the consolidated financial statements in our Annual Report 2024 for research and development costs in 2024,2023 and 202
187、2,respectively.Novo Nordisks research and development organization is comprising more than 10,000 employees as of December31,2024.Research costs comprise the early stages of the drug development cycle from the initial drug discovery until the drug is ready for administration to humans.The activities
188、 initially focus on identifying a single drug candidate with a profile that will support a decision to initiate development activities.Before selection of the final drug candidate,it is tested in animals to gather efficacy,toxicity and pharmacokinetic information.Development costs are incurred from
189、the start of phase 1,when the drug is administered to humans for the first time;these are the projects captured in the Pipeline overview(page 23 of our Annual Report 2024).The final product is developed,and subsequent clinical trials(phases 2 and 3)are conducted to further test the drug in humans,us
190、ing the results from these trials to attempt to obtain marketing authorization,permitting Novo Nordisk to market and sell the developed products.Historically,Novo Nordisk has spent approximately 70-80%of total research and development expenditures on clinical development activities,and approximately
191、 20-30%on research activities.The split between research and development will fluctuate in individual years depending on the composition of the clinical development portfolio.In general,Novo Nordisk expects that growth in research and development spending will follow a trend in line with or slightly
192、 above sales growth indicating that the research and development cost to sales ratio is expected to gradually increase in the foreseeable future.Thus,Novo Nordisk currently expects to modestly expand upon the current expenditure level of around 14-16%of sales in research and development activities g
193、oing forward.Increased early and late-stage clinical trial activities across all therapy areas as well as increased business development activities are driving costs.ITEM 5 OPERATING AND FINANCIAL REVIEW AND PROSPECTS12Novo Nordisk Form 20-F 2024Novo Nordisk has multiple phase 3 programs currently i
194、n progress,see the below table for the full list.The following Novo Nordisk compounds are currently in phase 3 development or have recently been filed for regulatory approval:COMPOUND/BRAND NAME/INDICATION Year entered into phase 3 or filed with the regulatory authoritiesPatent expirationConcizumab(
195、NN7415)/Haemophilia A and B with or without inhibitorsRegulatory submission for some indications ongoing20341Insulin Icodec(NN1436)/Once-weekly basal insulin analogueRegulatory submission in 202320372Semaglutide(oral)25 mg and 50 mg(NN9924)/DiabetesPhase 3 completed in 20232032Semaglutide(oral)25 mg
196、 and 50 mg/ObesityPhase 3 completed in 20242032Cagrisema(NN9388)/DiabetesPhase 3 initiated in 20232037Cagrisema(NN9838)/Obesity Phase 3 initiated in 20222037IcoSema(NN1535)/A combination of GLP-1 semaglutide and insulin icodec Regulatory submission in 202420372Etavopivat/Second generation selective,
197、small molecule PKR-activator intended for once-daily oral administration in sickle cell disease Phase 3 initiated in 202220393Mim8(NN7769)Phase 3 initiated in 202120404Semaglutide in MASH(NN9931)Phase 3 completed in 20242032Semaglutide in Alzheimers(NN6535)Phase 3 initiated in 20212032Ziltivekimab(N
198、N6018)/Cardiovascular diseaseZiltivekimab(NN6018)/Cardiovascular diseasePhase 3 initiated in 2021203551 Current estimate United States.Key EU markets estimate 2035,Japan expiry 20342 Current estimate of regulatory data protection in the United States.Key EU markets and Japan estimate 20343 Current e
199、stimate,United States.Key EU markets and Japan estimated in 20384 Current estimate,United States.Key EU markets estimate 2041 and Japan estimated in 20445 Current estimate,United States.Key EU markets and Japan estimate 2032.In addition to patents,the product is eligible for Regulatory Data Protecti
200、on,i.e.10 years from market authorization in the EU and 12 years from market authorization in the U.S.In determining whether or not any project or group of related projects is significant,we consider the following qualitative and quantitative criteria:Assessment of the unmet medical need targeted wi
201、th the specific project;The inherent project risk including the risk of safety issues,unsatisfactory tolerability profile,limitations on the efficacy of the compound;Timeline for completing the clinical testing and submitting an application for approval to regulatory authorities;Regulatory authoriti
202、es position towards approval and drug label;Changes in competitive landscape during the development and approval cycle including competing drugs being developed by others;Changes in medical practice during the development period;Position of payers,the medical society and patients towards treatment w
203、ith the drug and price of the drug;Expected uptake in market following launch;andExpected net present value of the project.In assessing the criteria listed above,we refer to Risks on pages 38-40 in our Annual Report 2024.It is important to note that due to the risks and uncertainties involved in pro
204、gressing through pre-clinical development and clinical trials,and the time and cost involved in obtaining regulatory approvals,we cannot reasonably estimate the nature,timing,completion dates and costs of the efforts necessary to complete the development.The nature of Novo Nordisks development activ
205、ities is such that a compound must first be ITEM 5 OPERATING AND FINANCIAL REVIEW AND PROSPECTS13Novo Nordisk Form 20-F 2024proven to work by means of multiple clinical trials,which may require treatment of thousands of patients and could take years to complete.Even if initial results of preclinical
206、 studies or clinical trial results are promising,the Company may obtain different results that fail to show the desired levels of safety and efficacy,or Novo Nordisk may not obtain applicable regulatory approval for a variety of other reasons.The compound must be approved by either the U.S.Food and
207、Drug Administration,the European Medicines Agency or by similar agencies around the world,each of which may have differing requirements.During each stage,there is a substantial risk that Novo Nordisk will encounter serious obstacles which will further delay us,or that the Company will not achieve it
208、s goals and,accordingly,may abandon a product in which it has invested substantial resources.Furthermore,the commercial potential of a project is dependent on the label granted by the regulatory authority upon approval.The label specifies for which indications a product is approved for,major and min
209、or safety concerns associated with drug treatment,as well as if the drug is approved for use in combination with other types of medication.Thus a label can restrict usage substantially.Reference is made to the caption Risk factors contained under Item 3 hereof.Given the uncertainties related to the
210、process of product development,during the periods presented in our 2024 Form 20-F no single project in product development was material to total R&D spend nor significant based on the qualitative and quantitative criteria.However,during the periods presented,two groups of projects were considered si
211、gnificant;the Diabetes and Obesity care group and the Rare disease group.Information related to selected research and development projects can be found under Research and development progress on page 24 of our Annual Report 2024.D.TREND INFORMATIONFor more information on commercial dynamics across N
212、ovo Nordisk therapy areas,we refer to Commercial Execution on pages 26-31 of our Annual Report 2024.The key drivers behind Novo Nordisks performance continue to be the changes in demographics globally reflecting a continuous growth in the proportion of people who live in cities(urbanization),an incr
213、easing proportion of elderly people and a growing prevalence of obesity.These trends have contributed to the significant increase in the number of people with diabetes and obesity worldwide.According to the International Diabetes Federation,the number of people with diabetes is projected to increase
214、 from 573 million today to 780 million in 2045.Additionally,there are currently more than 800 million people living with obesity.This is also expected to grow in the coming decades.Diabetes and Obesity care is Novo Nordisks largest segment comprising more than 90%of sales.The epidemic growth in the
215、number of people with diabetes and obesity and the increasing use of the GLP-1 category is driving Novo Nordisks growth within the Diabetes and Obesity care segment.Payers continued to leverage their size and control to demand higher rebates,particularly in the insulin segment,but increasingly in th
216、e GLP-1 category,as well.As a result,average prices after rebates for the Novo Nordisk portfolio in 2024 in the United States declined.Ultimately,pricing pressure is expected to continue in the future,driven by:increasing rebates in the commercial segment,the effect of payer consolidation,increasing
217、 exposure to high rebate channels such as Medicare and Medicaid,as well as increasing competition.In January 2021,Novo Nordisk changed its policy relating to 340B Drug Pricing Program(under Section 340B of the Public Health Service Act,pharmaceutical manufacturers participating in Medicaid are requi
218、red to sell outpatient drugs at discounted prices to certain health care organizations that care for uninsured and low-income patients),whereby Novo Nordisk no longer provides 340B statutory discounts to certain pharmacies that contract with covered entities participating in the 340B Drug Pricing Pr
219、ogram.Novo Nordisks 340B policy has been the subject of litigation in the U.S.courts.On January 30,2023,the U.S.Court of Appeals for the Third Circuit issued a ruling holding that Novo Nordisks drug distribution policy was consistent with the 340B statute.On May 21,2024,the U.S.Court of Appeals for
220、the DC Circuit issued a ruling in a related case involving other pharmaceutical manufacturers that similarly held that their drug distribution policies were consistent with the 340B statute.However,an appeal in another related case is still pending before the U.S.Court.See Note 3.5 Provisions and co
221、ntingent liabilities in the consolidated financial statements in our Annual Report 2024.In August 2022 the Inflation Reduction Act of 2022 was passed into law.This legislation included several healthcare reforms,which resulted in minor near-term sales impacts,but could also have medium and long-term
222、 impacts.Reference is made to Note 2.1 Net sales and rebates in the consolidated financial statements in our Annual Report 2024 for information on the Companys sales and rebates.For 2025,continued pricing pressure within Diabetes and Obesity Care is expected.ITEM 5 OPERATING AND FINANCIAL REVIEW AND
223、 PROSPECTS14Novo Nordisk Form 20-F 2024For further information on trends,reference is made to the section 2024 performance and 2025 outlook on pages 32-37 of our Annual Report 2024.Information about expectations for the financial year 2025 can be found on pages 34-35 in the subsection 2025 outlook.E
224、.CRITICAL ACCOUNTING ESTIMATES Reference is made to Note 1.1 Material accounting policies and key accounting estimates in the consolidated financial statements in our Annual Report 2024.ITEM 6 DIRECTORS,SENIOR MANAGEMENT AND EMPLOYEESA.DIRECTORS AND SENIOR MANAGEMENTReference is made to pages 42-44
225、of our Annual Report 2024 for name,position and period of service as director for members of the Board of Directors.Reference is made to page 45 of our Annual Report 2024 for name,position,age and other management duties for members of Executive Management,except in respect of Doug Langa.Business ex
226、perience,year of appointment and year of joining Novo Nordisk for each member of Executive Management are included below:Lars Fruergaard JrgensenPresident and chief executive officer(CEO)Mr Jrgensen joined Novo Nordisk in 1991 as an economist in Health Care,Economy&Planning and has over the years co
227、mpleted overseas postings in the Netherlands,the U.S.and Japan.In 2004 he was appointed senior vice president for IT&Corporate Development.In January 2013 he was appointed executive vice president and chief information officer assuming responsibility for IT,Quality&Corporate Development.In November
228、2014 he took over the responsibilities for Corporate People&Organisation and Business Assurance and became chief of staff.Mr Jrgensen was appointed president and chief executive officer in January 2017.Maziar Mike DoustdarExecutive vice president,International OperationsMr Doustdar joined Novo Nordi
229、sk in 1992 as an office clerk in Vienna,Austria.From 1993 through 2007 he took up various positions in finance,IT,logistics,operations and marketing,within various parts of Novo Nordisks emerging markets,first in Vienna and subsequently in Athens and Zurich before he was appointed general manager of
230、 Novo Nordisk Near East,based in Turkey,in 2007.In 2010 Mr Doustdar was promoted to vice president of Business AreaNearEast and in 2012 he re-located to Malaysia to head the Business Area Oceania South East Asia.In 2013 he was promoted to senior vice president of Novo Nordisks International Operatio
231、ns,and in April 2015 Mr Doustdar was promoted to executive vice president,continuing his responsibility for Novo Nordisks International Operations.In September 2016 Mike Doustdar assumed additional geographical responsibilities and was promoted to executive vice president for an expanded Internation
232、al Operations,leading all commercial units globally,except for the U.S.and Canada.Effective January 1,2025,Canada was integrated into IO.Ludovic HelfgottExecutive vice president,Rare diseaseMr Helfgott joined Novo Nordisk in April 2019 as executive vice president for Rare disease Mr Helfgott joined
233、Novo Nordisk from AstraZeneca,UK,where he was global vice president in charge of the companys cardiovascular,metabolism and renal global franchise.He joined AstraZeneca in 2005 in an international sales effectiveness role and has since held operational leadership roles with increasing responsibiliti
234、es in Italy,Spain and at corporate headquarters.Prior to this,Mr Helfgott was with McKinsey&Company in Paris,Moscow and Brussels from 1998 to 2005.Karsten Munk KnudsenExecutive vice president and chief financial officer(CFO)Mr Knudsen joined Novo Nordisk in 1999 as a business analyst in NNIT A/S,pre
235、viously a subsidiary of Novo Nordisk,and has since held finance positions of growing size and complexity throughout the Novo Nordisk value chain.From 2010 to 2014 Mr Knudsen was corporate vice president for Finance&IT at Novo Nordisk Inc.in the U.S.and in 2014 he was appointed senior vice president
236、of Corporate Finance in Novo Nordisk.In February 2018 Mr Knudsen was promoted to executive vice president and chief financial officer.In 2019 Mr Knudsen assumed further responsibilities as his area was expanded to cover Finance,Legal&Procurement,followed by a further expansion in 2022 where he assum
237、ed responsibility for Global Solutions.Effective January 1,2025,Mr Knudsen assumed responsibility for Novo Nordisks corporate strategy in addition to his current responsibilities.Martin Holst LangeExecutive vice president,DevelopmentMr Lange joined Novo Nordisk in 2002,as first operationally and sub
238、sequently medically responsible for several projects within Global Development.From 2006 to 2008 Mr Lange worked in Novo Nordisk Inc.,USA,in the Medical Department as senior medical director.In 2008,he moved back to Denmark and became vice president,Medical&Science liraglutide,transferring in 2010 t
239、o insulin degludec in a similar position.From 2013 to 2017,he served as corporate project vice president for Insulin&Diabetes Outcomes and subsequently Insulin&Devices.In January 2018,he was appointed senior vice president for Global Development.In March 2021,Mr Lange was appointed executive vice pr
240、esident for Development.From 1997 to 2002,Mr Lange did clinical work as well as clinical research of which the latter,three years at the Department of Endocrinology,National University Hospital,Denmark.Mr Lange has served on the board of directors of Beta Bionics Inc.,USA.ITEM 5 OPERATING AND FINANC
241、IAL REVIEW AND PROSPECTS15Novo Nordisk Form 20-F 2024Marcus SchindlerExecutive vice president,Research&Early Development and chief scientific officer(CSO)Mr Schindler joined Novo Nordisk in January 2018 as senior vice president for External Innovation and Strategy.From March 2018 to 2021 he was seni
242、or vice president for Global Drug Discovery and in March 2021,Mr Schindler was appointed executive vice president for Research&Early Development and chief scientific officer.Prior to joining Novo Nordisk Mr Schindler was vice president,head of cardiovascular and metabolic diseases innovative medicin
243、es at AstraZeneca,Sweden.From 2009 to 2012,he was head of research at(OSI)Prosidion,Oxford,UK.From 2000 to 2008,he worked in various leadership roles at Boehringer Ingelheim,Germany after having started his career with Glaxo Wellcome/GSK,UK in 1997.Camilla SylvestExecutive vice president,Commercial
244、Strategy&Corporate AffairsMs Sylvest joined Novo Nordisk in 1996 as a trainee.From 1997 to 2008 Ms Sylvest had roles in headquarters and regions within pricing,health economics,marketing and sales effectiveness.In 2003,she was appointed vice president of sales and marketing effectiveness in Region E
245、urope.From 2008 to 2015 Ms Sylvest headed up subsidiaries and business areas of growing size and complexity in Europe and Asia and in 2013 she was also appointed corporate vice president.In August 2015 Ms Sylvest was appointed senior vice president and general manager of Novo Nordisks Region China.I
246、n October 2017,Ms Sylvest was promoted to executive vice president for Commercial Strategy&Corporate Affairs.Henrik WulffExecutive vice president,Product Supply,Quality&ITMr Wulff joined Novo Nordisk in 1998 in the logistic and planning function.From 2001 to 2008 he held different managerial roles w
247、ithin Novo Nordisks manufacturing organization,Product Supply,before being appointed senior vice president of Diabetes API in Product Supply,Denmark.In 2012 Mr Wulff was appointed senior vice president of the worldwide division Diabetes Finished Products.In 2013 he was promoted senior vice president
248、 of Product Supply globally.In April 2015 Mr Wulff was promoted executive vice president and in 2019 his area of responsibility expanded to also cover Quality Assurance,Digital Data&IT.Tania SabroeExecutive vice president,People&OrganisationMs Sabroe joined Novo Nordisk in 2007 as a project manager
249、in Media Relations.Based out of Switzerland she held several positions in Novo Nordisks International Operations from 2013 to 2021 within both Media Relations,Communications and People&Organisation,including the position as corporate vice president of People&Organisation,Communication&Sustainability
250、 from 2018 to 2021.In January 2022 Ms Sabroe was appointed senior vice president of People&Organisation,Centres of Excellence&Services and in March 2023 she was promoted to executive vice president for People&Organisation.Prior to joining Novo Nordisk in 2007,Ms Sabroe held a position as a communica
251、tions manager at NHS National Services Scotland,UK.David MooreExecutive vice president,U.S.Operations&Business DevelopmentMr Moore first joined Novo Nordisk in 2017 as senior vice president of Marketing and later senior vice president of Commercial,both at Novo Nordisk in the U.S.,until leaving the
252、company in 2019.Mr Moore re-joined Novo Nordisk in September 2022 as senior vice president for Corporate Development and in March 2023 he was promoted to executive vice president for Corporate Development.Effective January 1,2025,David Moore also assumed the position of executive vice president of U
253、.S.Operations&Business Development.Prior to joining Novo Nordisk in 2017,Mr Moore held various commercial and executive roles with Johnson&Johnson,Tranzyme Pharma,Ocera Therapeutics and Cempra Pharmaceuticals.From 2019 to 2022 Mr Moore first served as CEO of the infectious disease business at Roivan
254、t Sciences,followed by being investment partner with Gurnet Point Capital.Effective January 1,2025,Doug Langa stepped aside from his role as executive vice president of North America Operations.As Executive Management has become a global team,all executives based in Denmark apart from the CEO and CF
255、O were deregistered from the Danish Business Authority as members of Executive Management,or registered managers,within the meaning of the Danish Companies Act,effective December 31,2023,to align the registration practice and to treat all team members equally,regardless of where they are based.Novo
256、Nordisk has a two-tier management structure consisting of the Board of Directors and Executive Management.The Board of Directors and Executive Management are separate bodies and have no overlapping members.The Board of Directors is responsible for the overall strategic management and supervision of
257、Novo Nordisks affairs and supervises the work of Executive Management.Executive Management is responsible for the day-to-day management of the Company,development and implementation of strategies and policies,the Companys operations and organization and timely reporting to the Board of Directors and
258、 Novo Nordisks stakeholders.The key roles of members of the Board of Directors and members of Executive Management outside the Company are included in our Annual Report 2024 under the section Management on pages 41-45.ITEM 6 DIRECTORS,EXECUTIVE MANAGEMENT AND EMPLOYEES16Novo Nordisk Form 20-F 2024Th
259、ere are no family relationships between the Board of Directors,Executive Management or between any of the members of the Board of Directors and any member of Executive Management.No director or member of Executive Management has been elected according to an arrangement or understanding with sharehol
260、ders,customers,suppliers or others.As required by the Danish Companies Act,members of board of Directors are elected by the general meeting by a simple majority vote.Members of the Board of Directors elected by the general meeting are elected for a term of one year until the next annual general meet
261、ing and may be re-elected.In addition,four employee representatives are elected for a statutory four-year term by the employees of Novo Nordisk A/S.B.COMPENSATIONFor compensation data in respect of the members of the Companys Board of Directors,reference is made to section 2.1 Key developments in Bo
262、ard remuneration in 2024,section 2.2 Remuneration composition,section 2.4 Board and committee fee levels 2024 and section 2.5 Board remuneration 2024 in our Remuneration Report 2024.For compensation data in respect of the members of the Companys Executive Management,reference is made to section 3.1
263、Key developments in executive remuneration 2024,section 3.2 Remuneration composition,section 3.4 Executive remuneration in 2024,section 3.5 Short-term incentive programme 2024,section 3.6 Long-term incentive programme design,section 3.7 Long-term incentive programme 2022 and section 3.8 Long-term in
264、centive programmes 2023 and 2024 in our Remuneration Report 2024 and Note 5.1 Share-based payment schemes in the consolidated financial statements in our Annual Report 2024.C.BOARD PRACTICESThe year of election and term for each member of the Board of Directors is included on pages 42-43 of our Annu
265、al Report 2024.The year of appointment for each member of Executive Management is included in Item 6A.The Audit CommitteeThe Audit Committee mainly assists the Board of Directors with the oversight of:external auditors;the internal audit function;handling complaints reported through the Compliance H
266、otline(the Companys whistleblower complaint system);financial and sustainability reporting(environmental,social and governance);enterprise risk management system and financial counterpart exposure;internal controls over financial and ESG reporting;business ethics compliance;information security;insu
267、rance coverage and special theme reviews.Under Danish law,the statutory external auditor is elected by the general meeting.All shareholders as well as the Board of Directors have the right to propose external auditor candidates for election.The Audit Committee recommends to the Board of Directors th
268、e statutory external auditor to be nominated by the Board of Directors and elected by the shareholders at the annual general meeting.As part of its oversight of external reporting,the Audit Committee perform assessments of the risk exposure of Novo Nordisk,including the impact on the financial and s
269、ustainability processes and accounting for material legal and tax issues.The Audit Committee has quarterly discussions with the chief financial officer,head of finance and compliance,the general counsel,head of group internal audit and the external auditor.The chief financial officer is charged with
270、 responsibility for the tax strategy and policy,which is endorsed by the Board of Directors.The Audit Committee consists of five members elected by and from the Board of Directors.One member of the Audit Committee is designated as chair and one member is an employee-elected member of the Board of Di
271、rectors.In March 2024,the Board of Directors elected the following members to the Audit Committee:Laurence Debroux(member since 2019 and chair since 2021,independent),Sylvie Grgoire(member since 2015,independent),Mette Bjer Jensen(member since 2022,employee-elected member of the Board of Directors,n
272、ot independent but relies on an exemption,reference is made to item 16D in this Form 20-F),Christina Law(member since 2022,independent)and Henrik Poulsen(member since 2021,not independent but relies on an exemption,reference is made to item 16D in this Form 20-F).The Remuneration CommitteeThe Remune
273、ration Committee assists the Board of Directors with the preparation and/or oversight of:the Remuneration Policy for the members of the Board of Directors and Executive Management;the remuneration of the members of the Board of Directors and its committees;the remuneration and employment terms of Ex
274、ecutive Management;the Remuneration Report and other reporting.The Remuneration Committee has four members elected by and from the Board of Directors.One member of the Remuneration Committee is designated as chair and one member is an employee-elected member of the Board of Directors.In March 2024,t
275、he Board of Directors elected the following members to the Remuneration Committee:Henrik Poulsen(member since 2022 and chair since 2023,not independent),Elisabeth Dahl Christensen(member since 2022,employee-elected member of the ITEM 6 DIRECTORS,EXECUTIVE MANAGEMENT AND EMPLOYEES17Novo Nordisk Form
276、20-F 2024Board of Directors,not independent),Laurence Debroux(member since 2021,independent)and Martin Mackay(member since 2021,independent).Directors service contractsReference is made to the section Corporate Governance,page 16 of our Annual Report 2024 for the description of the termination payme
277、nts for Executive Management.D.EMPLOYEESReference is made to Note 2.4 Employee costs in the consolidated financial statements in our Annual Report 2024 regarding the total number of full-time employees in Novo Nordisk at year-end for the years 20242022.Employees outside Denmark as a percentage of th
278、e total number of employees for 2024 was 54%(2023:55%and 2022:58%).Executive Management believes that the Company has a good relationship with its employees in general and with the labour unions of the Novo Nordisk employees.E.SHARE OWNERSHIPFor information on the Board of Directors and Executive Ma
279、nagement members individual holdings of shares and restricted stock units,including shares and restricted stock units granted in the year ended December 31,2024 and trading in shares by the Board of Directors and Executive Management in the same period,reference is made to section 2.6 Shareholdings
280、of Board Members and section 3.9 Shareholdings of Executive Management in our Remuneration Report 2024 and Note 5.1 Share-based payment schemes in the consolidated financial statements in our Annual Report 2024.As of February 4,2025,the members of the Board of Directors and Executive Management held
281、 1,534,378 B shares,representing in the aggregate less than 1%of the beneficial ownership of the Company.In the period from January 1,2025 until February 4,2025,no B shares were sold or purchased by the members of the Board of Directors or Executive Management.The internal rules on trading in Novo N
282、ordisk securities by members of the Board of Directors and Executive Management only permit trading in the 15 calendar day period following each quarterly earnings announcement.For information on vested shares for Executive Management on February 5,2025,reference is made to section 3.7 Long-term inc
283、entive programme 2022 in our Remuneration Report 2024.For further information,reference is made to Note 5.1 Share-based payment schemes in the consolidated financial statements in our Annual Report 2024.F.DISCLOSURE OF A REGISTRANTS ACTION TO RECOVER ERRONEOUSLY AWARDED COMPENSATIONNone.ITEM 7 MAJOR
284、 SHAREHOLDERS AND RELATED PARTY TRANSACTIONSA.MAJOR SHAREHOLDERSFor information on major shareholders reference is made to Shares and capital structure on pages 36-37 of our Annual Report 2024.Novo Nordisk Foundation(the Foundation)owns its shares in Novo Nordisk A/S through Novo Holdings A/S.The pu
285、rpose of Novo Holdings A/S is to administer the Foundations portfolio of securities and minority capital interests and to administer and vote on the A shares and B shares in Novo Nordisk A/S,thereby securing a satisfactory financial return for Novo Holdings A/S sole shareholder,the Foundation.Under
286、the Foundations statutes,the Foundation is governed by a board of directors,which must be comprised of six to twelve members(of whom at least two members must have a medical or scientific background,and at least one of these two members must have a medical background).Members of the Foundations boar
287、d of directors are typically nominated by the Foundations nomination committee and elected by a two-thirds vote of the board members who have themselves been previously elected pursuant to the Foundations statutes.Any board member can be removed as provided for in the Danish Act on Foundations(lov o
288、m erhvervsdrivende fonde).In addition,employee-elected board members are elected for a statutory four-year term by the employees of the Foundation and of the subsidiaries of the Foundation.No person or entity exercises any kind of formal influence over the Foundations board.The Foundations board cur
289、rently consists of ten persons.Under Novo Holdings A/S statutes,Novo Holdings A/S is governed by a board of directors,which must be comprised of three to nine members elected annually by the shareholders.According to the Foundations statutes,its board can and shall provide for members of its own boa
290、rd of directors to be elected to Novo Holdings A/S board of directors.Novo Holdings A/S board of directors is currently ITEM 6 DIRECTORS,EXECUTIVE MANAGEMENT AND EMPLOYEES18Novo Nordisk Form 20-F 2024comprised of nine members,two of whom are also members of the Foundations board of directors(Steen R
291、isgaard and Lars Rebien Srensen)and one of whom is also member of the board of directors of Novo Nordisk A/S(Henrik Poulsen).Moreover,the chief executive officer of Novo Holdings A/S(Kasim Kutay)is also a member of the Board of Directors of Novo Nordisk A/S.The chair of the Foundations board of dire
292、ctors(Lars Rebien Srensen)serves as the chair of Novo Holdings A/S board of directors.The A shares in Novo Nordisk A/S held by Novo Holdings A/S cannot be sold or be subject to any disposition so long as the Foundation exists.The dissolution of the Foundation or any change in its objectives requires
293、 a unanimous vote of the Foundations board of directors.Other changes in the Foundations statutes require approval of two-thirds of the Foundations board members and approval by the Danish foundation authorities.According to its statutes,the Foundation is required to maintain material influence over
294、 Novo Nordisk A/S and its majority vote in Novo Holdings A/S.For further information reference is made to Shares and capital structure on pages 36-37 of our Annual Report 2024.The B shares of Novo Nordisk A/S are registered with Euronext Securities(legal name:VP Securities A/S(Euronext)and are not r
295、epresented by certificates.Generally,Euronext does not provide the Company with information with respect to registration.However,set forth below is information as of February 4,2025 with respect to(a)any shareholder who is known to the Company to be the owner of more than 5%of any class of Novo Nord
296、isk A/S securities and(b)the total amount of any class owned by Novo Nordisk A/S and its subsidiaries(treasury shares)and by the Board of Directors and Executive Management as a group:Title of classIdentity of person or groupShares ownedPercent of classPercent of totalvotesA shares Novo Holdings A/S
297、 1,074,872,000 100.00 76.02 B shares Novo Holdings A/S 177,560,500 5.24 1.26 B shares Novo Nordisk A/S and subsidiaries(treasury shares)25,947,151*0.77 0.18 B shares Board of Directors and Executive Management 1,534,378 0.05 0.01*)Treasury shares are included,however,voting rights of treasury shares
298、 cannot be exercised.For information on share repurchases under the Companys share repurchase program in 2022/2023 reference is made to Note 4.2 Distribution to shareholders in the consolidated financial statements in our Annual Report 2024.Information on the 2024/2025 share repurchase program,refer
299、ence is made to Shares and capital structure on pages 36-37 of our Annual Report 2024.There is no complete record of all shareholders,nor of U.S.shareholders,and therefore it is not possible to give an accurate breakdown of geographical distribution of share capital nor of the number of B shareholde
300、rs by country of residence.Additionally,certain of our B shares are held by brokers or other nominees and,as a result,the number of holders of record is not representative of the number of beneficial holders or of the residence of such beneficial holders.However,based on available sources of informa
301、tion,as of December 31,2024 it is estimated that share capital(including A and B share capital)was geographically distributed in the following manner:38%Denmark,28%North America,3%UK,and 31%Other.Furthermore,JPMorgan Chase Bank,N.A.,our ADR Depositary,has informed us that as of December 31,2024 the
302、total number of ADRs outstanding was 440,748,211 representing approximately 13.82%of the issued B share capital outstanding(excluding treasury shares and shares held by Novo Holdings A/S)as at that date.All of the Companys ADRs are held of record by the Depositary.For more information regarding our
303、ADRs,see Item 12D below.B.RELATED PARTY TRANSACTIONSRelated parties include the Novo Nordisk Foundation,Novo Holdings A/S,Novonesis A/S,Innate Pharma SA,Xellia Pharmaceuticals ApS,Altasciences Group,Sonion A/S(due to shared controlling shareholder,Novo Holdings A/S)and NNIT A/S being an associated c
304、ompany with shared controlled shareholding between Novo Holdings A/S and Novo Nordisk A/S.In 2024 Novo Nordisk acquired three fill-finish manufacturing sites from Novo Holdings A/S in connection with a transaction where Novo Holdings A/S acquired Catalent,Inc.The purchase price of the three sites to
305、talled USD 11.7 billion,which was mainly debt-financed.Related party transactions in 2024,2023 and 2022 were primarily payments for services provided between the Novo Nordisk Group and the Novonesis Group,Xellia Pharmaceuticals ApS,Altasciences Group,Sonion A/S and transactions with associated compa
306、nies.The overall financial impact of these related party transactions is limited.ITEM 7 MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS19Novo Nordisk Form 20-F 2024Being an associated company of Novo Nordisk A/S,Churchill Stateside Solar Fund XIV,LLC(CS Solar Fund XIV)is considered a related party
307、.Being an associated company of Novo Holdings A/S,Unchained Labs,Inc.is considered a related party to Novo Nordisk A/S.Novo Nordisk A/S has access to certain assets of and can purchase certain services from Novo Holdings A/S and Novonesis A/S and vice versa.All agreements relating to such assets and
308、 services are based on the list prices used for sales to third parties where such list prices exist,or the price has been set at what is regarded as market price.The material terms of these agreements are renegotiated on a regular basis.Since December31,2024,there have been no further significant tr
309、ansactions with related parties out of the ordinary course of business.For further information reference is made to Note 5.4 Related party transactions in the consolidated financial statements in our Annual Report 2024.C.INTERESTS OF EXPERTS AND COUNSELNot applicable.ITEM 8 FINANCIAL INFORMATIONA.CO
310、NSOLIDATED STATEMENTS AND OTHER FINANCIAL INFORMATIONThe financial statements required by this item accompany this annual report in the form of our Annual Report 2024(filed as Exhibit 15.1 to this Form 20-F).Legal proceedingsReference is made to Note 3.5 Provisions and contingent liabilities in the
311、consolidated financial statements in our Annual Report 2024.DividendsReference is made to Shares and capital structure,on pages 36-37 of our Annual Report 2024.B.SIGNIFICANT CHANGESNo significant events have occurred since the date of the annual financial statements.For description of important even
312、ts and achievements in 2024,reference is made to Introducing Novo Nordisk on pages 4-10 and 2024 performance and 2025 outlook on pages 32-37 of our Annual Report 2024.ITEM 9 THE OFFER AND LISTINGA.OFFER AND LISTING DETAILSThe Companys B shares are listed in Denmark on Nasdaq Copenhagen,and traded un
313、der the symbol NOVO-B.The Companys ADRs are traded on the New York Stock Exchange(the NYSE)under the symbol NVO.See Exhibit 2.2 to this Form 20-F for a description of the B Shares.B.PLAN OF DISTRIBUTIONNot applicable.C.MARKETSReference is made to Shares and capital structure,on pages 36-37 of our An
314、nual Report 2024.D.SELLING SHAREHOLDERSNot applicable.E.DILUTIONNot applicable.F.EXPENSES OF THE ISSUENot applicable.ITEM 8 FINANCIAL INFORMATION20Novo Nordisk Form 20-F 2024ITEM 10 ADDITIONAL INFORMATIONA.SHARE CAPITALNot applicable.B.MEMORANDUM AND ARTICLES OF ASSOCIATIONSee Exhibit 2.2.to this Fo
315、rm 20-F for a summary of certain material provisions of Novo Nordisk A/S Articles of Association,certain other constitutive documents and relevant Danish corporate law.See Exhibit 1.1 to this Form 20-F for a translation into English language of the Articles of Association.C.MATERIAL CONTRACTSThere h
316、ave been no material contracts outside the ordinary course of business.D.EXCHANGE CONTROLSOther than the Danish rules on screening of certain foreign direct investments(FDI),etc.in Denmark(the Danish FDI Rules)and applicable international trade and financial sanctions as outlined below,(i)there are
317、no governmental laws,decrees,or regulations in Denmark(including,but not limited to,foreign exchange controls)that restrict the export or import of capital,or that affect the remittance of dividends,interest or other payments to non-resident holders of the B shares or the ADRs,and(ii)there are no li
318、mitations on the right of non-resident or foreign owners to hold or vote the B shares or the ADRs imposed by the laws of Denmark or the Articles of Association of the Company.Under the Danish FDI Rules,a screening mechanism applies to foreign direct investments in certain sensitive sectors,if the fo
319、reign investor obtains at least 10%ownership or voting rights,or equivalent control by other means.Among such sensitive sectors are companies and entities within critical infrastructure in Denmark that are necessary to maintain or restore the production,registration,distribution,and monitoring of pr
320、escription drugs.If a contemplated foreign direct investment in Novo Nordisk A/S is considered to fall within the scope of the mandatory screening mechanism,the foreign investor is required to apply for prior authorization with the Danish Business Authority.FDI filings,notifications or approvals may
321、 under certain circumstances also be required in non-Danish jurisdictions.If a foreign investor fails to comply with the Danish FDI Rules,the Danish Business Authority may impose restrictions,inter alia,ordering to reverse the investment or to suspend the foreign investors voting rights.Internationa
322、l trade and financial sanctions are continually evolving.If applicable,such international trade and financial sanctions may under certain circumstances prevent the possibility of export and import of capital,and affect the remittance of dividends,interests and other payments to the non-resident hold
323、ers of the B shares or the ADRs.In addition,international trade and financial sanctions may also restrict the right of non-resident or foreign owners to acquire,transfer,hold or vote the B shares and ADRs.Failure to comply with international trade and financial sanctions can lead to criminal and civ
324、il liability.E.TAXATIONDanish TaxationThe following summary outlines certain Danish tax consequences to U.S.Holders(as defined below):Withholding TaxGenerally,Danish withholding tax is deducted from dividend payments to U.S.Holders at a 27%rate,the rate generally applicable to non-residents in Denma
325、rk without regard to eligibility for a reduced treaty rate.Under the current Convention between the Government of the United States of America and the Government of the Kingdom of Denmark for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with respect to Taxes on Income(the Cu
326、rrent Convention),the maximum rate of Danish tax that may be imposed on a dividend paid to a U.S.Holder that does not have a permanent establishment(as defined therein)in Denmark is generally 15%and,for certain pension funds,0%(each,the Treaty Rate).U.S.Holders eligible for the Treaty Rate may apply
327、 to the Danish tax authorities to obtain a refund to the extent that the amount withheld reflects a rate in excess of the Treaty Rate(any such amount,the Excess Withholding Tax).Any U.S.Holders of ADRs wishing to apply for a refund of Excess Withholding Tax will have to provide a Danish Claim for Re
328、fund of Danish Dividend Tax,a properly completed U.S.Internal Revenue Service Form 6166 and additional documentation including:proof of dividend received;proof of ownership of the ADR and eligibility for the dividend received and proof that the dividend received was reduced by an amount correspondin
329、g to the Danish withholding tax.These documentation requirements may be expanded and may ITEM 10 ADDITIONAL INFORMATION21Novo Nordisk Form 20-F 2024be subject to change.Refund claims must be filed within the three-year period following the date in which the dividend was paid in Denmark.Information o
330、n tax reclaims,how they should be filed and the requisite tax forms may be obtained from:JPMorgan Chase Bank,N.A.c/o Globe Tax Services,Inc.1 New York Plaza,34th FloorNew York,New York 10004 USAPhone:+1(212)747 9100U.S.Holders should consult their tax advisers regarding dividend withholding tax refu
331、nds.Sale or Exchange of ADRs or B SharesAny gain or loss realized on the sale or other disposition of ADRs or B shares by a U.S.Holder that is not either a resident of Denmark or a corporation that is doing business in Denmark is not subject to Danish taxation.In addition,any non-resident of Denmark
332、 may remove from Denmark any convertible currency representing the proceeds of the sales of ADRs or B shares in Denmark.U.S.TaxationThe following summary outlines certain U.S.federal income tax consequences for U.S.Holders(defined below)of owning and disposing of ADRs or B shares.A U.S.Holder is a p
333、erson that,for U.S.federal income tax purposes,is a beneficial owner of ADRs or B shares that is eligible for the benefits of the Current Convention and is(i)a citizen or individual resident of the United States,(ii)a corporation,or other entity taxable as a corporation,created or organized in or under the laws of the United States or any state therein or the District of Columbia,or(iii)an estate