《諾和諾德Novo Nordisk(NVO)2024年年度報告「NYSE」(英文版)(152頁).pdf》由會員分享,可在線閱讀,更多相關《諾和諾德Novo Nordisk(NVO)2024年年度報告「NYSE」(英文版)(152頁).pdf(152頁珍藏版)》請在三個皮匠報告上搜索。
1、Novo Nordisk A/S Novo Alle 1,2880 Bagsvrd,Denmark CVR no.24256790ANNUALREPORT2024Novo Nordisk employees Steve Piaget and Marie Ange Gahozo from our site in Kalundborg,Denmark,overseeing an active construction project.This project is part of our investment of more than DKK 80 billion in new active ph
2、armaceutical ingredient facilities.These significant expansions aim to scale up production of life-changing treatments,including GLP-1-based medicines,to benefit many more people living with serious chronic diseases.MANAGEMENT REPORT101 Consolidated financial statements102 Income statement and State
3、ment of comprehensive income103 Cash flow statement104 Balance sheet105 Equity statement106 Notes to the Consolidated financial statements138 Statements and auditors reports138 Statement by the Board of Directors and Executive Management139 Independent auditors report141 Independent auditors limited
4、 assurance report on Sustainability statement143 Additional information144 More information145 Product overview146 Financial statements of the parent company47 General information47 ESG performance49 Basis for preparation of the Sustainability statement50 Sustainability governance51 Interests and vi
5、ews of stakeholders52 Double materiality assessment54 Environment54 Climate change60 Resource use and circular economy64 Pollution65 Water67 Biodiversity and ecosystems69 EU Taxonomy71 Social71 Patient protection and quality of life80 Own workforce88 Workers in the value chain90 Governance 90 Busine
6、ss conduct95 Appendix Annual reviewSustainability statementFinancial statements and additional information4 Introducing Novo Nordisk5 Letter from the Chair and the CEO7 Key figures8 Purpose and strategy9 Value creation10 Strategic Aspirations 2025 progress11 Strategic Aspirations12 Purpose and susta
7、inability17 Innovation and therapeutic focus26 Commercial execution32 Financials38 Risks41 Management42 Board of Directors45 Executive Management2We have been committed to integrated reporting since 2004,when we first started evaluating our performance based on social,environmental and financial imp
8、act.This commitment was further strengthened in 2019 with the adoption of our Strategic Aspirations 2025,which cover our financial and sustainability ambitions.This year,in line with the CSRD,we have conducted a double materiality assessment to identify the sustainability matters that are most impor
9、tant to Novo Nordisk,considering both societal and financial implications.The essential topics identified include patient protection and quality of life,climate change,resource use and circular economy,and own workforce reflecting our aspirations of progress towards zero environmental impact,being r
10、espected for adding value to society and being a sustainable employer.The outcomes of this assessment have provided us with key metrics to track our performance across our material sustainability topics.You can read more about our progress towards achieving our sustainability ambitions in the Annual
11、 review on page 12,while detailed breakdowns of our performance can be found in the Sustainability statement on page 46.Together,these sections make up this years Management report.Moreover,our commitment to sustainability is reflected in our incentive programmes,which incorporate our Strategic Aspi
12、rations 2025 into both individual and corporate performance targets.This highlights our dedication to driving sustainable growth and creating long-term value for all stakeholders.A new chapter in our integrated reporting The Annual Report 2024 marks a significant step in the evolution of Novo Nordis
13、ks integrated reporting.This year,our Sustainability statement is for the first time prepared according to the EU Corporate Sustainability Reporting Directive(CSRD)requirements.Strategic Aspirations3 Corporate Sustainability Reporting Directive including a double materiality assessmentMaterial topic
14、s and key metricsINTRODUCINGNOVO NORDISK5 Letter from the Chair and the CEO7 Key figures8 Purpose and strategy9 Value creation10 Strategic Aspirations 2025 progressHarish Manikandan lives with obesity in Chile.Harish maintains an active lifestyle in the bustling city of Santiago and,amid his daily d
15、uties as head chef at a restaurant,finds tranquility on his electric bike,commuting to work,cycling in the citys expansive parks and cruising Santiago in the evenings when the temperature cools and the traffic is light.4Building a healthier tomorrowThe global prevalence of serious chronic diseases i
16、s growing by the day,impacting millions of lives and placing a heavy burden on overstretched healthcare systems.This has created unprecedented demand for our life-changing GLP-1-based medicines.Over the past four years,we have more than quadrupled the number of people reached with these treatments a
17、nd increased our volume market share in the GLP-1 segment to 63%.In 2024,we served more than 45.2 million people living with serious chronic diseases,while our global sales and operating profit both grew by 26%at constant exchange rates.As we strive to keep pace with the growing demand for our medic
18、ines,our production capacity has been stretched.In response,we have continued to invest heavily in scaling up our manufacturing capabilities with capital expenditure and acquisitions amounting to more than DKK 129 billion in 2024.The acquisition of three fill-finish sites formerly run by contract an
19、d development manufacturer Catalent Inc.,along with significant expansions of our existing production facilities in Denmark,France,Brazil,China and the US,are testament to our commitment to improving supply stability.In order to meet increasing demand and ensure a stable supply of our medicines,we a
20、re also taking steps to consolidate our product portfolio by gradually phasing out some of our older insulin products.This will create much-needed space in our global manufacturing network as we seek to reach millions more people with our medicines over the next decade.At the same time,we strive not
21、 to leave existing patients without alternative treatment options,either from Novo Nordisk or other companies,and we remain committed to working closely with local health authorities and the medical community to enable access to affordable care.Our belief that health is a fundamental human right dri
22、ves our extensive partnership programmes and access initiatives.In times of geopolitical instability,safeguarding access to care for those in conflict zones and underserved areas is paramount.Our partnerships with humanitarian organisations such as the Danish Red Cross play a crucial role in this ef
23、fort,demonstrating our dedication to making a difference where it is needed most.2024 was a year of significant growth for Novo Nordisk,characterised by continued innovation,capacity expansions and strong commercial execution.As we reflect on our progress,we also recognise the magnitude of the chall
24、enges that lie ahead.Chair of the Board of Directors,Helge Lund(left)and President and CEO,Lars Fruergaard Jrgensen(right).5Annual review /Introducing Novo Nordisk /Letter from the Chair and the CEOMoreover,we are increasing our investment in preventive health measures through initiatives like Citie
25、s for Better Health a pioneering urban health partnership now active in 51 cities worldwide and our collaboration with UNICEF to prevent childhood obesity.These efforts aim to address the root causes of serious chronic diseases,thereby reducing the global health burden and fostering a healthier futu
26、re.Our Transformational Prevention Unit complements our partnership-driven approach,looking to develop scalable,science-based solutions that can predict and pre-empt obesity and its consequences.The same scientific rigour is being applied across our R&D activities,which are driving transformative ch
27、ange across multiple therapy areas.Rooted in our deep understanding of proteins and peptides and fuelled by research partnerships,AI-driven drug discovery and the acquisition of new technology platforms,we are striving to accelerate the discovery of new targets and optimise our clinical trials to th
28、e benefit of people living with serious chronic diseases.Innovation remains our core contribution to society and the driving force behind our continued growth.The past year has seen us add to the growing body of clinical evidence supporting the broad cardiometabolic and societal benefits of semaglut
29、ide the molecule at the heart of our flagship GLP-1-based medicines Ozempic,Wegovy and Rybelsus and we are confident that our pipeline has the potential to add even more value.In obesity,we completed the first phase 3 trial of CagriSema,currently in development for the treatment of obesity or overwe
30、ight and type 2 diabetes.After 68 weeks,if all people adhered to treatment,CagriSema demonstrated a statistically significant weight loss of 22.7%vs 2.3%with placebo alone.This is among the highest weight reductions yet seen in a phase 3a programme for a GLP-1 combination therapy.We intend to furthe
31、r explore the weight loss potential of CagriSema in an additional study.Earlier in our obesity pipeline,topline results from a phase 1b/2a trial of subcutaneous amycretin have demonstrated the weight lowering potential of the unimolecular GLP-1 and amylin receptor agonist,supporting previous data se
32、en with the oral formulation.When evaluating the effects of treatment if all people adhered to treatment,those receiving a 20 mg dose of amycretin experienced an estimated average weight loss of 22.0%over 36 weeks compared to 2%weight gain with placebo.In diabetes,the first launches of Awiqli the wo
33、rlds first once-weekly basal insulin exemplify our enduring commitment to innovation in this space more than 100 years after we first started producing insulin.Moreover,our dedication to addressing unmet needs within rare disease is exemplified by the pending regulatory submission of Mim8 for the tr
34、eatment of haemophilia A.The growth of our business has inevitably led to an increase in our environmental footprint,and we are stepping up efforts to mitigate this impact.We have introduced comprehensive,updated roadmaps targeting reductions in our emissions,plastic footprint and impact on nature a
35、nd biodiversity.Achieving these ambitions will be no small feat given the increasing global demand for our medicines,but we are rising to the challenge.Our roadmaps include measures to decouple our environmental impact from our continued growth by incorporating the use of low-carbon materials across
36、 our value chain,supporting our suppliers through a transition to renewable energy and facilitating a switch from disposable to reusable injection devices for our medicines wherever possible.Our operating environment is also becoming more complex,shaped by geopolitical tensions,global conflicts and
37、technological advancements.Our unique ownership structure,underpinned by the Novo Nordisk Foundation as controlling shareholder,provides us with the stability we need to navigate these uncertainties.This model supports our sustainable growth by allowing us to take a long-term view on our investments
38、 and strategies;crucial in a volatile world where short-term market pressures can often lead to reactive decision-making.We are similarly mindful of the importance of sustainably scaling our organisation.We are now 77,349 colleagues worldwide an increase of 20%compared to 2023 that reflects our comm
39、itment to scaling up in the face of growing demand.Our focus is on ensuring new hires receive the support and resources they need to fully integrate into our global workforce and connect with the Novo Nordisk Way the core guiding principles that underpin everything we do.This approach also safeguard
40、s our focus on diversity and inclusion,fostering an environment where every employee feels valued and included.As we look forward to 2025 and beyond,we are optimistic about the opportunities that lie ahead as we strive to serve millions more people with serious chronic diseases.However,we are also m
41、indful of the challenges inherent to our growth and the need to balance short-term costs with long-term societal value.Our purpose remains clear:driving change to defeat serious chronic diseases.By staying true to our purpose and values,we are confident in our ability to navigate the complexities of
42、 the ever-evolving global healthcare landscape and to continue making a meaningful difference in the lives of millions of people worldwide.We would like to extend our gratitude to all Novo Nordisk colleagues worldwide for their hard work and dedication at a time of unprecedented demand for our life-
43、changing medicines,and to our shareholders for their continued support of our company.Helge LundChair of the Board of DirectorsLars Fruergaard JrgensenPresident and CEO Annual review /Introducing Novo Nordisk /Letter from the Chair and the CEO6DKK million202020212022202320242023-24Financial ratiosCh
44、angeGross margin383.5%83.2%83.9%84.6%84.7%Sales and distribution costs in percentage of sales25.9%26.3%26.1%24.4%21.4%Research and development costs in percentage of sales12.2%12.6%13.6%14.0%16.6%Operating margin342.6%41.7%42.3%44.2%44.2%Net profit margin333.2%33.9%31.4%36.0%34.8%Cash to earnings167
45、.8%61.4%103.3%81.6%(14.6%)Return on invested capital182.8%69.0%73.6%88.5%63.9%Share performance and capital allocationBasic earnings per share/ADR in DKK39.0310.4012.2618.6722.6721%Diluted earnings per share/ADR in DKK39.0110.3712.2218.6222.6322%Total number of shares(million),end of year4,7004,6204
46、,5604,5104,465(1%)Dividend per share in DKK44.555.206.209.4011.4021%Total dividend(DKK million)421,06623,71127,95041,98750,68321%Dividend payout ratio350.0%49.6%50.3%50.2%50.2%Share repurchases(DKK million)16,85519,44724,08629,92420,181(33%)Closing share price(DKK)214368469698624(11%)DKK million2020
47、20212022202320242023-24Financial performanceChangeNet sales126,946140,800176,954232,261290,40325%Sales growth as reported4.0%10.9%25.7%31.3%25.0%Sales growth in constant exchange rates16.7%13.8%16.4%35.6%25.7%Operating profit54,12658,64474,809102,574128,33925%Operating profit growth as reported3.1%8
48、.3%27.6%37.1%25.1%Operating profit growth in constant exchange rates16.8%12.7%14.6%43.7%26.2%Depreciation,amortisation and impairment losses5,7536,0257,3629,41319,107103%EBITDA1,259,87964,66982,171111,987147,44632%EBITDA growth as reported3.0%8.0%27.1%36.3%31.7%EBITDA growth in constant exchange rat
49、es6.7%12.0%14.9%42.4%32.7%Net financials(996)436(5,747)2,100(1,148)Profit before income taxes53,13059,08069,062104,674127,19122%Effective tax rate320.7%19.2%19.6%20.1%20.6%Net profit 42,13847,75755,52583,683100,98821%Purchase of property,plant and equipment35,8256,33512,14625,80647,16483%Purchase of
50、 intangible assets316,2561,0502,60713,0904,145(68%)Cash used for acquisition of businesses18,2837,07582,163Free cash flow128,56529,31957,36268,326(14,707)Total assets144,922194,508241,257314,486465,79548%Equity 63,32570,74683,486106,561143,48635%Key figures45.277,34951380Novo Nordisk is a leading gl
51、obal healthcare company,founded in 1923 and headquartered in Denmark.million people living with diabetes and obesity reachedemployees worldwidecountries with R&D facilitiescountries with production facilitiescountries with affiliates1.See Non-IFRS financial measures.2.EBITDA is defined as net profit
52、,adjusted for income taxes,financial items,depreciation and amortisation and impairment losses and reversals.3.See Financial definitions and ratios.4.Total dividend for the year including interim dividend of DKK 3.50 per share,corresponding to DKK 15,583 million,which was paid in August 2024.The rem
53、aining DKK 7.90 per share,corresponding to DKK 35,100 million,will be paid subject to approval at the Annual General Meeting in March 2025.7Annual review /Introducing Novo Nordisk /Key figuresPurpose and strategyAt Novo Nordisk,our purpose is clear:driving change to defeat serious chronic diseases.T
54、hrough our life-changing innovations,we are building a healthier future for generations to come.DiabetesStrengthen leadership by offering innovative medicines and driving patient outcomesRare DiseaseSecure a leading position by leveraging full portfolio and expanding into adjacent areasObesityStreng
55、then leadership through market development and by offering innovative medicines and driving patient outcomesCardiovascular&Emerging Therapy AreasEstablish position in cardiovascular disease and build a presence in emerging therapy areasNovo Nordisk WaySustainable businessDriving change to defeat ser
56、ious chronic diseasesWe are dedicated to reinforcing our leadership in diabetes and obesity,securing a leading position in rare diseases and establishing ourselves as a key player in cardiovascular disease.Additionally,we are actively building our presence in the treatment of metabolic dysfunction-a
57、ssociated steatohepatitis,chronic kidney disease and Alzheimers disease.We create value on multiple fronts.Through the Novo Nordisk Way,we ensure our employees thrive in a supportive and innovative environment.We operate as a responsible business,striving to address environmental and social impacts,
58、to create value for society and fulfil our financial commitments to shareholders,ensuring sustainable growth and success.Our value chain is similarly comprehensive,encompassing every stage from the initial concept of a new treatment to its final delivery to people living with serious chronic disease
59、s.This includes our own operations in R&D and manufacturing,as well as collaborations with suppliers to source materials and distribute our treatments effectively.8Annual review /Introducing Novo Nordisk /Purpose and strategyResearch and developmentResourcesManufacturingDistributionPatientsInsights
60、from patients,healthcare experts and partnersRaw materialsDiverse talentFinancial resourcesReached more than 45.2 million people living with serious chronic diseasesInvested more than DKK 129 billion mainly in production capacity to meet demand for current and future products Added 13,030 employees
61、bringing Novo Nordisks total workforce to 77,349,while supporting job-creation amongst our suppliersInvested more than DKK 52 billion in R&DReached 8.4 million vulnerable people living with diabetesOwnership structureThe Novo Nordisk Foundation awards grants in three strategic areas:health,sustainab
62、ility and the life science ecosystem.In 2024,more than DKK 10 billion were awarded.The Novo Nordisk Foundation holds 77.3%of votes and 28.1%of shares in Novo Nordisk A/S through Novo Holdings A/S.This unique ownership structure supports sustainable growth by allowing us to take a long-term view on o
63、ur strategies and investments while maintaining short-term transparency on performance.Paid out more than DKK 64 billion via dividends and share buybacks to shareholders,including Novo Holdings A/SValue creationWe focus on creating lasting value for society and our business with a strong commitment
64、to financial,environmental and social responsibility.Following the Novo Nordisk Way,we are dedicated to delivering long-term value for people living with serious chronic diseases,our employees,partners,shareholders and society at large.9Annual review /Introducing Novo Nordisk /Value creationStrategi
65、c Aspirations 2025 progressStrategic Aspirations 2025ProgressPurpose andsustainabilityProgress towards zero environmental impact Overall CO2e emissions(scope 1,2 and full scope 3)increased by 23%compared to 2023Being respected for adding value to society Medical treatment provided to 43.0 million pe
66、ople living with diabetes and 2.2 million people living with obesity Reached more than 64,000 children in the Changing Diabetes in Children programmeBeing recognised as a sustainable employer Share of women in senior leadership positions has increased by 0.7 percentage point to 42%compared to 2023Su
67、stainable supply chain Acquisition of Catalent by Novo Holdings and the related acquisition by Novo Nordisk of three manufacturing sites from Novo Holdings completedInnovation and therapeutic focusFurther raise the innovation-bar for Diabetes treatment Awiqli approved in the EU,Japan and China Compl
68、ete Response Letter received for insulin icodec in the US Successful completion of phase 3a programme with IcoSema US approval and positive EU opinion for an update of the Ozempic label based on the FLOW kidney trial Submission of the SOUL cardiovascular outcomes trial and STRIDE functional outcomes
69、 trial in the US and EUDevelop a leading portfolio of superior treatment solutions for Obesity Phase 2 trial initiated with once-weekly GIP/GLP-1 dual agonist Phase 2a trial with monlunabant completed CagriSema demonstrated superior weight loss in the REDEFINE 1 trial Phase 3b trials,STEP UP and STE
70、P UP T2D,with semaglutide 7.2 mg successfully completed Phase 1b/2a trial with injectable amycretin successfully completed Phase 1 trial with a tri-agonist(Triple)initiatedStrengthen and progress the Rare disease pipeline Phase 3a trial,FRONTIER 2,with Mim8 successfully completed in people with haem
71、ophilia A Successful completion of the phase 2 part(interim)of the etavopivat HIBISCUS phase 2/3 trial Alhemo(Concizumab)approved in the US and EU for the treatment of haemophilia A and B with inhibitors Alhemo submitted in the EU for the treatment of haemophilia A and B without inhibitorsEstablish
72、presence in Cardiovascular&Emerging Therapy Areas focusing on CVD,MASH and CKD Agreement to acquire Cardior Pharmaceuticals and lead asset CDR132L in phase 2 development for treatment of heart failure Phase 3 development initiated with ziltivekimab in HFpEF and AMI Phase 3 trial CLARION-CKD trial st
73、opped as ocedurenone failed to meet primary endpoint Successful completion of part I of phase 3 trial ESSENCE with semaglutide 2.4 mg in MASHCommercialexecutionStrengthen Diabetes leadership aim at global value market share of more than 1/3 Diabetes value market share remained unchanged at 33.7%(MAT
74、)More than DKK 25 billion in Obesity sales by 2025 Obesity care sales increased by 57%(CER)to DKK 65.1 billionSecure a sustained growth outlook for Rare disease Rare disease sales increased by 9%(CER)to DKK 18.6 billionFinancialsDeliver solid sales and operating profit growth Sales growth of 26%(CER
75、)Operating profit growth of 26%(CER),negatively impacted by impairment losses related to intangible assetsDrive operational efficiencies across the value chain to enable investments in future growth assets Operational leverage reflecting sales growth,when excluding impairment lossesDeliver free cash
76、 flow to enable attractive capital allocation to shareholders Free cash flow of DKK(14.7)billion,negatively impacted by the Catalent transaction DKK 64.3 billion returned to shareholders10Annual review /Introducing Novo Nordisk /Strategic Aspirations 2025 progressSTRATEGICASPIRATIONS12 Purpose and s
77、ustainability17 Innovation and therapeutic focus26 Commercial execution32 FinancialsNovo Nordisk employees Jayashri Seshadri and Merlin Till Witte in our laboratories in Mlv,Denmark.Jayashri and Merlin are part of a transformational research unit working to improve the lives of people living with se
78、rious chronic diseases through innovative stem cell-based therapies.11PURPOSE AND SUSTAINABILITYDriving change in human and planetary healthAs the global prevalence of serious chronic diseases continues to increase,overburdened healthcare systems face growing pressure to deliver cost-effective,quali
79、ty care,while millions of people lack access to essential treatments.In 2024,we reached more than 45.2 million people with our life-changing medicines an increase of 3.6 million compared to 2023.As our business grows,so does our social responsibility to support vulnerable populations,and this year w
80、e were able to reach 8.4 million vulnerable people living with diabetes a slight decrease compared to 2023.With the aim of addressing growing health inequities,we are broadening our access and affordability initiatives,including programmes like Changing Diabetes in Children.Since its inception in 20
81、09,this programme has provided care and support to more than 64,000 young people keeping us on track to achieve our ambition of reaching a total of 100,000 children by 2030.Prevention is similarly critical to reducing the global health burden,and we are investing more in preventive health measures t
82、han ever before.Our GLP-1-based medicines hold the potential to deliver substantial long-term healthcare savings by improving patient outcomes and reducing the need for more intensive treatments.Meanwhile,the 2024 expansion of our pioneering urban health initiative,Cities for Better Health,showcases
83、 our growing ambition to drive change outside the clinic.Building upon a decade of insights,this expanded partnership programme now includes a Childhood Obesity Prevention Initiative(COPI)aiming to deliver measurable,community-driven interventions that promote healthy eating and physical activity am
84、ong children living in underprivileged urban communities.Initially launching in six cities across five continents,COPI complements our existing work with UNICEF to prevent this escalating problem.We also prioritise environmental sustainability including nature and biodiversity across our value chain
85、 and have a clear focus on decoupling our environmental impact from our growth as we progress towards our net zero 2045 emissions target.This will be a significant challenge with emissions continuing to rise as our business expands to keep pace with demand,but we are determined to step up to the tas
86、k.To this end,we have updated roadmaps targeting reductions in our emissions,plastic footprint and impact on nature and biodiversity,each laying out a clear path towards creating a more sustainable business.Key focus areas include supporting our suppliers through a transition to renewable energy,swi
87、tching to reusable injection devices for our medicines wherever possible and exploring the use of low-impact glucose alternatives in our production processes.Despite the scale of the challenges ahead,our commitment to improving human and planetary health remains unwavering.We are determined to do mo
88、re with less reaching more vulnerable people with our life-saving medicines and doing more to curb the rising prevalence of serious chronic diseases,all while minimising our environmental impact.Strategic Aspirations 20251 Progress towards zero environmental impact2 Being respected for adding value
89、to society3 Being recognised as a sustainable employerIn an increasingly complex and unpredictable world,the intersection of climate change,health inequity and the rising prevalence of serious chronic diseases presents an unprecedented risk to both human and planetary health.Recognising the magnitud
90、e of these challenges,we are aiming to expand the reach and societal impact of our life-changing medicines and preventive health initiatives while striving to reduce our CO2e emissions,plastic footprint and impact on nature.12Annual review /Strategic Aspirations /Purpose and sustainability202420238.
91、48.8Vulnerable people living with diabetes reached1Million1.The 2023 figure has been restated.Read more on page 75.202347512024We are taking determined action to prevent serious chronic diseases,focusing on improving urban health for vulnerable communities and preventing childhood overweight and obe
92、sity.These efforts are complemented by our Transformational Prevention Unit,which aims to develop scalable and accessible science-based solutions that can predict and pre-empt obesity and its consequences.Our pioneering urban health programme,Cities for Better Health(CBH),sits at the forefront of ou
93、r prevention efforts.Now with a broadened scope that aligns with our expansion into new therapy areas,this public-private partnership drives action to prevent serious chronic diseases across a global network of 51 large cities.The Childhood Obesity Prevention Initiative(COPI)is the latest initiative
94、 to come out of CBH.Taking aim at childhood overweight and obesity,it seeks to deliver measurable,community-driven interventions promoting healthy eating and physical activity among children living in underprivileged urban communities.Guided by a global evidence-based framework,these measures will t
95、arget children aged between six and 13,aiming to positively affect diet and physical activity,improve health-related quality of life and promote healthy weight.The initiative complements our ongoing collaboration with UNICEF to tackle childhood obesity,where we are focusing on building healthy envir
96、onments that enable and empower children to eat well and be active.Driving change in chronic disease preventionTackling growing health disparitiesCities reached via our Cities for Better Health programmeChildren playing in Campinas,Brazil,one of the launch cities of COPI.Bilguissa Balde was one of t
97、he first people supported by CDiC.Today,she guides and inspires younger children also living with type 1 diabetes in Guinea.Millions currently lack access to diabetes care due to high costs or unavailability,often with devastating consequences.In 2024,we reached 8.4 million vulnerable people with di
98、abetes,a 5%decrease from last year,mainly due to reduced tender sales of human insulins.Despite this,our commitment to addressing health inequity remains unwavering.We are intensifying efforts to make care more affordable for vulnerable populations,improve supply chains and build capacity for diagno
99、sis and disease management.Key initiatives include Changing Diabetes in Children(CDiC),which has reached over 64,000 children with type 1 diabetes in low-and middle-income countries since 2009.Support can include free life-saving medicine,blood glucose monitoring equipment and medical supplies for y
100、oung people under 25.In the past year,the programme integrated new digital elements to support access to care in vulnerable settings.This includes the Diabetes Besties video series,which helps bridge the gap in patient education for children living with diabetes.Other initiatives include Partnering
101、for Change,a collaboration with the Danish Red Cross to address health issues in humanitarian crises,and iCARE,an integrated business model aimed at breaking down barriers to diabetes care in Middle Africa and Indonesia.iCARE provides affordable insulin,trains healthcare providers and empowers peopl
102、e with diabetes to improve their health and quality of life.13Annual review /Strategic Aspirations /Purpose and sustainability1.The 2023 figure has been restated;read more about this and our emissions targets on page 57.Our commitment to delivering life-changing medicines to millions of people world
103、wide compels us to responsibly manage our use of water,energy and resources.We have made significant progress in reducing our scope 1 and 2 emissions since 2019.However,our scope 3 emissions,which comprise about 96%of our total emissions,continue to rise as we grow to meet increasing demand for our
104、medicines.To achieve net zero emissions by 2045,we have a roadmap to reduce scope 3 emissions by 33%by 2033,using 2024 as the baseline.This target which covers nearly 70%of our scope 3 emissions in accordance with Science Based Targets initiative(SBTi)provisions is aligned with climate science and h
105、as been submitted to the SBTi for validation.Key decarbonisation measures include switching to low-carbon materials and feedstock across our production network,shifting our distribution model to low-emissions transportation and supporting our suppliers in transitioning to renewable energy.To date,mo
106、re than 1,800 suppliers have already committed to make the switch.At the same time,we acknowledge that these measures will not be enough to meet our target,and will therefore investigate additional levers including new technologies to close this gap.Additionally,we have sharpened our focus on the im
107、pact of our operations on nature and biodiversity,setting an ambition to halt nature loss across our value chain by 2033 and achieving nature-positive status by 2045.Decoupling environmental impact from our growthReducing our plastic footprintAround the world,millions of people with serious chronic
108、diseases depend on medical devices.Once used,many of these devices end up in landfills or are incinerated,wasting tonnes of valuable materials that could be recycled.As the number of people who rely on our medicines increases,so does our obligation to help address the related environmental issues in
109、cluding plastic waste.To this end,we are targeting a 30%reduction in the amount of plastic used per patient by 2033,underpinned by the adoption of a reduce,change and avoid approach across our diabetes and obesity portfolio.We aim to achieve this by transitioning from disposable to reuseable devices
110、 and by developing new medicines designed to be administered less frequently.In addition,we are scaling up our ReMed device take-back scheme to avoid plastic waste ending up in landfills.ReMed is built on the success of our local take-back pilot programmes,enabling pen users to return their used dev
111、ices to give the plastic a new life.Four years on,and more than four million returned pens since the launch of the first pilot,the scheme is now active in seven key markets including Denmark,where we collaborate with other healthcare companies to offer a unique industry-wide solution.The same collab
112、orative model will be piloted in the UK in 2025.“We are targeting a 30%reduction in the amount of plastic used per patient by 2033”0.40.30.20.10Plastic footprintPlastic footprint per patient,kg/patient/year20242033 Plastic Target0.350.250202420232,5002,0001,5001,000500020452033Scope 1,2 and 3 emissi
113、ons1CO2e emissions(1,000 tonnes)Scope 1:Direct emissions from owned/controlled sources Scope 2:Indirect emissions from purchased energy Scope 3:Indirect emissions in the value chain Scope for 2033 target Target1,000+23%-33%-30%1,8362,261 14Annual review /Strategic Aspirations /Purpose and sustainabi
114、lityWe create value by having a patient-centred business approach.We set ambitious goals and are empowered to achieve them.We are accountable for our financial,environmental and social performance.We are curious and innovate for the benefit of patients and society at large.We build and maintain good
115、 relations with our stakeholders.We value diversity and treat everyone with respect.We focus on performance and personal development.We have a healthy and engaging working environment.We strive for agility and simplicity in everything we do.We never compromise on quality and ethics.The extraordinary
116、 surge in demand for our life-changing medicines in recent years has led to a substantial increase in the number of new hires as we expand our workforce to keep pace.Last year alone,we added 13,030 employees across our global organisation,which now comprises 77,349 colleagues worldwide.Our focus is
117、on sustainably scaling our organisation;ensuring it is run efficiently,our priorities remain clear and our resources are used optimally.This approach helps safeguard the wellbeing of our expanding workforce and bolsters our reputation as a highly engaged and supportive place to work.Last year,we rec
118、orded an overall engagement score of 85%in our annual company survey,which saw a record 90%of all employees participate.To support the integration of our new colleagues,we aim to equip all new hires with the support and resources they need to onboard and connect with our strong company culture and p
119、urpose,which remain essential to our success.By dedicating additional time and resources to this integration process,we also help to foster an environment that values diverse perspectives and ensures every employee feels included.Moreover,it is crucial that we maintain a sustainable work-life balanc
120、e for all our employees.As our business grows,we are carefully monitoring workplace stress levels,targeting a 10%annual reduction in the number of employees reporting symptoms of stress.Although we did not meet this target in 2024,when overall stress levels remained unchanged year-on-year at 13.8%,w
121、e will continue to implement new measures to address symptoms of stress at the earliest opportunity.The foundation of our commitment to supporting the wellbeing and development of our employees is the Novo Nordisk Way;a set of guiding principles constituting the core of our identity and operations.I
122、t bridges our companys past,present and future,steering our strategy,decisions and behaviours.By familiarising new employees with the 10 Essentials that direct the decisions and actions of every Novo Nordisk colleague,we uphold our dedication to the companys core values of openness,accountability an
123、d respect.We employ a distinctive,systematic approach known as facilitation value audits to ensure that all employees adhere to these Essentials.Sustainably scaling our organisation The Novo Nordisk Way Essentials12345891076“Our focus is on sustainably scaling our organisation;ensuring it is run eff
124、iciently,our priorities remain clear and our resources are used optimally”15Annual review /Strategic Aspirations /Purpose and sustainabilityGovernance structureThe shareholders of Novo Nordisk exercise their rights at the Annual General Meeting,which is the supreme governing body of the company.The
125、general meeting,inter alia,adopts the companys Articles of Association,approves the Annual Report and elects the Board of Directors.Any shareholder has the right to raise questions at general meetings.Resolutions can generally be passed by a simple majority.However,resolutions to amend the Articles
126、of Association require two-thirds of the votes cast and capital represented,unless other adoption requirements are imposed by the Danish Companies Act.Novo Nordisk has a two-tier management structure consisting of the Board of Directors and Executive Management.The governance structure and rules of
127、Novo Nordisk are further described in our Articles of Association and our Corporate Governance Report,both available at: ownershipNovo Holdings A/S,a Danish company wholly owned by the Novo Nordisk Foundation,holds the majority of votes at Novo Nordisk A/S general meetings.The combination of foundat
128、ion ownership and stock listing enables Novo Nordisk to embark on long-term sustainable strategies while maintaining short-term transparency on performance.Our foundation ownership supports the overarching imperative to be both commercially successful and responsive to the wider needs of society.The
129、 Novo Nordisk Foundation has two objectives:to provide a stable basis for the commercial and research activities of Novo Nordisk,Novonesis and additional companies in Novo Holdings investment portfolio;and to support scientific,humanitarian and social causes.Please refer to the section on value crea
130、tion on page 9.For more information about the ownership structure of Novo Nordisk,see page 36.Corporate governance reportingNovo Nordisk reports in accordance with the Danish Corporate Governance Recommendations,which are implemented by Nasdaq Copenhagen in the Nordic Main Market Rulebook for Issuer
131、 of Shares,as well as the Corporate Governance Standards of the New York Stock Exchange applicable to foreign private issuers.Novo Nordisk complies with the Danish Corporate Governance Recommendations as we account for which recommendations we comply with or deviate from and explain our chosen appro
132、ach.You can find further information about our corporate governance practices and statement on our approach to each of the Danish Corporate Governance Recommendations as well as the Corporate Governance Standards of the New York Stock Exchange in our Corporate Governance Report,available at: remuner
133、ation is linked to financial performance as well as non-financial performance (e.g.innovation and sustainability).Novo Nordisk has prepared a separate Remuneration Report describing the remuneration awarded or due during 2024 to the Board of Directors and Executive Management members registered with
134、 the Danish Business Authority.The Remuneration Report is submitted to the Annual General Meeting for an advisory vote.The Remuneration Policy and the Remuneration Report are available at: regarding change of control provisionsIt is disclosed that Novo Nordisk does not have any material contracts th
135、at take effect,alter or terminate upon a change of control of Novo Nordisk following implementation of a takeover bid.In the event of termination whether by Novo Nordisk or by the individual due to a merger,acquisition or takeover of Novo Nordisk,members of Executive Management registered with the D
136、anish Business Authority are,in addition to the notice period,entitled to a severance payment of 24 months base salary plus pension contribution.Ethics and complianceIn Novo Nordisk,we have an ethics and compliance programme which comprises of a code of conduct(OneCode),requirements(The Ethics Navig
137、ator),processes and awareness and capability building as stipulated in the seven elements of an effective compliance programme.Data privacy is a key component in our ethical principles,ensuring guardrails are in place to manage and mitigate risks,thus safeguarding our patients and society at large.W
138、e have also adopted a set of principles for data and artificial intelligence(AI)ethics to support ethical decision-making.We have initiated building our AI Ethics&Compliance framework,incorporating elements such as principles,requirements and risk assessments,as well as building AI literacy training
139、 and capabilities.You can read more about these principles,in accordance with the Danish Financial Statements Act Section 99d,at: governance16Annual review /Strategic Aspirations /Purpose and sustainabilityINNOVATION AND THERAPEUTIC FOCUSOur evolution from a diabetes-centric company to an organisati
140、on with a broader focus on metabolic and cardiovascular health requires even sharper prioritisation across our portfolio.To do this,we have established the role,purpose and ambition level for each therapy area based on future opportunities,while at the same time assessing our competitive strengths a
141、nd the capabilities required to unlock these opportunities.The result is a clear set of priorities that guide our R&D and external business development activities across therapy areas.These include significant investments in novel technological platforms as well as strategic collaborations and acqui
142、sitions that expand our research horizons and ensure we remain at the forefront of therapeutic innovation.Our primary strategic focus remains on strengthening our leadership position in diabetes and obesity.The latter is an increasingly critical area of unmet medical need,impacting more than one bil
143、lion people worldwide.Our robust pipeline underscores our ambition to develop transformative treatment solutions.Notable advancements include the phase 3 development of CagriSema,an innovative once-weekly combination of an amylin analogue(cagrilintide)and GLP-1 receptor agonist(semaglutide),and succ
144、essfully completing the phase 1b/2a trial with subcutaneous amycretin,a unimolecular long-acting GLP-1 and amylin receptor agonist.Driven by a strong focus on strategic partnerships and external innovation,our modality portfolio has expanded significantly in recent years,and now incorporates diverse
145、 approaches including proteins and peptides,small interfering ribonucleic acid(siRNA),small molecules,cell therapy and gene editing.This diversification enables us to leverage multiple modalities for target biology,enhancing our ability to address complex diseases.Ongoing projects include collaborat
146、ions with biotech firms including Heartseed(cell therapy)and Ventus Therapeutics(small molecules)to identify novel drug candidates for the treatment of heart failure and atherosclerotic cardiovascular disease,while the acquisition of the megaTAL technology platform from longstanding partner 2seventy
147、 bio has enhanced our in-house gene editing capabilities in haemophilia.Artificial intelligence(AI)and human data also play a pivotal role in our R&D activities.By leveraging real-world evidence and diverse data cohorts,we are able to enhance our early discovery processes,while our AI-driven data mi
148、ning and analyses help us mitigate risks involved in translating findings from animal models to humans.This approach accelerates the discovery of new targets and increases the likelihood of clinical success.Our R&D hub in the greater Boston area,a world-leading life sciences cluster,exemplifies this
149、 forward-thinking approach,working with local partners to leverage the power of machine learning,big data and AI to enhance our R&D capabilities.As healthcare innovation accelerates at an unprecedented rate,Novo Nordisk is driving transformative change across multiple therapy areas,with a particular
150、 focus on meeting unmet patient needs in diabetes,obesity,cardiovascular diseases and rare blood disorders.Through strategic investments in AI-driven drug discovery,clinical trial optimisation and new technological platforms,our ambition is to set new standards for innovation that deliver tangible,l
151、asting improvements to the lives of the people we serve.Empowering patients with life-changing innovationsStrategic Aspirations 20251 Further raise the innovation-bar for Diabetes treatment2 Develop a leading portfolio of superior treatment solutions for Obesity3 Strengthen and progress the Rare dis
152、ease pipeline4 Establish presence in Cardiovascular&Emerging Therapy Areas focusing on CVD,MASH and CKD11.Cardiovascular disease,metabolic dysfunction-associated steatohepatitis and chronic kidney disease.17Annual review /Strategic Aspirations /Innovation and therapeutic focusDeveloping breakthrough
153、 innovations in obesityObesity is a public health crisis impacting more than one billion people worldwide.Meeting unmet needs in obesity is a critical focus area for Novo Nordisk,and our aim is to build a differentiated portfolio of superior treatment solutions that go beyond weight loss to deliver
154、meaningful improvements in overall metabolic and cardiovascular health and physical function.Over the past year,we have strengthened our leadership position in this dynamic and rapidly-growing space.At the forefront of these advancements are two promising investigational therapies:CagriSema and amyc
155、retin.CagriSema,currently in phase 3 development for the treatment of obesity or overweight and type 2 diabetes,aims to combine the proven efficacy of semaglutide with the potential complementary benefits of cagrilintide,a novel amylin analogue.Topline results from the pivotal REDEFINE 1 phase 3a tr
156、ial demonstrated 22.7%weight loss vs 2.3%with placebo alone after 68 weeks if all people adhered to treatment among the highest reductions yet seen in a phase 3a programme for a GLP-1 combination therapy.CagriSema appeared to have a safe and well-tolerated profile in the study.The most common advers
157、e events were gastrointestinal,and the vast majority were mild to moderate and diminished over time,consistent with the GLP-1 receptor agonist class.With the insights obtained from the REDEFINE 1 trial,we plan to further explore the weight loss potential of CagriSema in an additional study.Amycretin
158、,a novel unimolecular GLP-1 and amylin receptor agonist,aims to combine the physiological effects of these two biologies,enhancing glucose-dependent insulin secretion,inhibiting glucagon release,slowing gastric emptying and promoting satiety.Findings from a phase 1b/2a study of subcutaneous amycreti
159、n demonstrated a safety profile consistent with incretin-based therapies.The most common adverse events were gastrointestinal and the vast majority were mild to moderate in severity.When evaluating the effects of treatment if all people adhered to treatment,amycretin demonstrated an estimated body w
160、eight loss of 9.7%on 1.25 mg(20 weeks),16.2%on 5 mg(28 weeks)and 22.0%on 20 mg(36 weeks).People treated with placebo experienced an estimated 1.9%,2.3%and 2.0%body weight gain,respectively.These results support the weight lowering potential of amycretin previously seen with the once-daily oral formu
161、lation,which demonstrated 13.1%weight loss after 12 weeks in a phase 1 study.In addition to these developments,we successfully completed two phase 3b obesity trials with semaglutide 7.2 mg.When evaluating the effects of treatment if all people adhered to treatment over 72 weeks,semaglutide 7.2 mg de
162、monstrated 20.7%weight loss vs 2.4%with placebo in people with obesity in the STEP UP study,and 14.1%weight loss vs 3.6%with placebo in people with obesity and type 2 diabetes in the STEP UP T2D study.We are also continuing to unpack the full data sets from our landmark SELECT trial programme,which
163、include samples from approximately 11,000 people collected over a five-year period.Enhanced by AI and digital capabilities,these data can help us identify new targets and biomarkers for future projects and predict disease progression and treatment response.Patricio Argelles lives with obesity in Mex
164、ico.18Annual review /Strategic Aspirations /Innovation and therapeutic focusPioneering transformationaltreatments for diabetesThe discovery of insulin more than 100 years ago transformed diabetes from a death sentence into a manageable disease.Today,we are still driving change in diabetes by improvi
165、ng quality of life through innovative new treatments and delivery devices.The past year has been no exception,characterised by advancements in our diabetes pipeline that demonstrate our commitment to raising the bar for innovation in this ever-evolving therapy area.CagriSema is a once-weekly combina
166、tion of an amylin analogue(cagrilintide)and a GLP-1 receptor agonist(semaglutide).It is currently in phase 3 development for the treatment of type 2 diabetes in the REIMAGINE programme to assess its effects on blood glucose regulation,body weight and broader metabolic health parameters.A separate ph
167、ase 3 programme REDEFINE is also investigating CagriSema for the treatment of obesity.We are also making progress in the development of a once-weekly GIP/GLP-1 receptor dual agonist,aiming to leverage the combined benefits of two powerful incretin hormones.By activating both GIP(gastric inhibitory p
168、olypeptide)and GLP-1 receptors,this investigational therapy aims to enhance blood sugar control,increase insulin secretion,reduce glucagon levels and promote weight loss.In type 1 diabetes,our early-stage pipeline has similarly transformative potential.Key projects include Pumpsulin,which aims to de
169、liver a novel fast-acting insulin optimised for use in future insulin pump-based fully closed-loop CSII(Continuous Subcutaneous Insulin Infusion)systems,and our work on developing a glucose-sensitive insulin.Currently in phase 1 clinical development,this cutting-edge therapy is designed to automatic
170、ally respond to the bodys glucose levels,offering a more dynamic and physiological approach to insulin treatment.Another notable example is our DNA immunotherapy project.Targeted at individuals recently diagnosed and at risk of developing type 1 diabetes,this investigational therapy aims to transfor
171、m the management of the disease by addressing the root cause of the immune systems harmful response.Administered through regular injections,it seeks to retrain the immune system to stop attacking insulin-producing cells in the pancreas.By doing so,the therapy aims to preserve the bodys natural abili
172、ty to produce insulin,potentially preventing or delaying the onset of type 1 diabetes.Novo Nordisk employee Jacob Sten Petersen and his daughter Vita at the Breakthrough T1D Walk in the US.Vita was diagnosed with type 1 diabetes at age three.“The therapy aims to preserve the bodys natural ability to
173、 produce insulin,potentially preventing or delaying the onset of type 1 diabetes”19Annual review /Strategic Aspirations /Innovation and therapeutic focusCARDIOVASCULAR&EMERGING THERAPY AREASCardiovascular disease,the worlds biggest killerCardiovascular diseases(CVD)are the leading cause of death glo
174、bally,taking an estimated 17.9 million lives each year.The prevalence of CVD is on the rise,driven by factors such as ageing populations,lifestyle changes and increasing rates of obesity and diabetes.This growing burden underscores the urgent need for innovative treatments to manage and mitigate the
175、 impact of cardiovascular(CV)conditions.Although CVD is a crowded,highly competitive therapy area,significant unmet needs persist.Our GLP-1-based therapies Ozempic,Wegovy and Rybelsus have all demonstrated a reduction in risk of major adverse CV events in separate cardiovascular outcomes trials,addi
176、ng to the growing body of evidence supporting the robust cardiometabolic profile of semaglutide.Beyond our portfolio of GLP-1-based medicines,we are also developing a pipeline of CV assets targeting specific,underserved areas where we can leverage our expertise in metabolic diseases.Central to these
177、 efforts is ziltivekimab,our lead CV candidate currently in phase 3 development across multiple CV indications.Acquired as part of a business development deal to bring Boston-based biotech firm Corvidia Therapeutics in-house back in 2020,ziltivekimab is an investigational monoclonal antibody designe
178、d to target interleukin-6(IL-6),a protein in the inflammation pathway linked to the development of different CV conditions.By targeting IL-6,ziltivekimab is under investigation to reduce inflammation and potentially improve outcomes across a spectrum of CV conditions including atherosclerotic cardio
179、vascular disease,heart failure with preserved ejection fraction,and acute myocardial infarction.Phase 2 data demonstrated that ziltivekimab significantly lowers inflammation biomarkers linked to atherosclerosis in individuals with advanced chronic kidney disease.With phase 3 trials now in progress,o
180、ur goal is to establish the first-in-class therapy as a foundational treatment for high-risk cardiovascular patients,aiming to improve cardiovascular outcomes by targeting systemic inflammation.With the potential to improve outcomes across several indications,ziltivekimab exemplifies our commitment
181、to strengthening our position in the CVD space.Greg Patterson lives with cardiovascular disease in the US.“Phase 2 data demonstrated that ziltivekimab significantly lowers inflammation biomarkers linked to atherosclerosis in individuals with advanced chronic kidney disease”20Annual review /Strategic
182、 Aspirations /Innovation and therapeutic focusCARDIOVASCULAR&EMERGING THERAPY AREASTania DaSilva works at Novo Nordisk in the US and lives with MASH.Semaglutide has already proven its effectiveness in enhancing glycaemic control,promoting weight loss and reducing cardiovascular risk.Now,it has demon
183、strated potential as a treatment for metabolic dysfunction-associated steatohepatitis(MASH),a progressive liver disease that affects more than 250 million people worldwide.MASH is characterised by liver inflammation and damage due to fat accumulation.If left untreated,this condition can progress to
184、cirrhosis and liver failure,posing a significant health risk.Yet with only one pharmacological treatment approved specifically for MASH,there is significant unmet need in the space for effective therapeutic options.According to the headline results from part one of the ESSENCE trial,semaglutide 2.4
185、mg demonstrated a statistically significant and superior improvement in liver fibrosis with no worsening in steatohepatitis as well as resolution of steatohepatitis with no worsening of liver fibrosis at 72 weeks.This initial phase of the study included 800 people with MASH and moderate to advanced
186、liver fibrosis.Part two of the trial,designed to evaluate the long-term impact of semaglutide 2.4 mg on liver-related clinical events,is set to continue until 2029.Meanwhile,Novo Nordisk plans to file for regulatory approval in the US and EU in the first half of 2025.“Semaglutide 2.4 mg demonstrated
187、 a statistically significant and superior improvement in liver fibrosis with no worsening in steatohepatitis”“By combining AI with high-throughput experimentation,we have assessed one billion virtual molecules via computer modelling and screened approximately 2,500 compounds in the lab”Emerging ther
188、apies for MASHWe are revolutionising our R&D efforts through artificial intelligence(AI),particularly in drug discovery,molecular design and clinical trial optimisation.In drug discovery,AI is playing a pivotal role in identifying new compounds.By combining AI with high-throughput experimentation,we
189、 have assessed one billion virtual molecules via computer modelling and screened approximately 2,500 compounds in the lab.This led to the discovery of a highly selective amylin compound that closely mimics the natural hormone,requiring 50-75%fewer design rounds.Molecular design has also advanced thr
190、ough AI.By leveraging predictive pharmacology and knowledge mining,we are able to accelerate the design cycles of new molecules,expediting development and enhancing the precision of targeted therapies.AI is also optimising our clinical trials by identifying subpopulations,improving trial design and
191、site selection and forecasting outcomes.For example,harmonising data from around 1,600 clinical trials,including SELECT and STEP,has provided best-in-class cardiometabolic data,leading to improved disease insights,patient stratification and drug target identification.We are also enhancing our AI cap
192、abilities through strategic partnerships.Our recently expanded collaboration with Valo Health is a prime example of our approach,seeking to accelerate the development of up to 20 novel drug programmes within the cardiometabolic space by leveraging cutting-edge AI technology and extensive human datas
193、ets.Pioneering AI in research and developmentARTIFICIAL INTELLIGENCEYogesh Shelke works in US R&D at Novo Nordisk.21Annual review /Strategic Aspirations /Innovation and therapeutic focusPioneering new treatments for rare blood disorders Ebrar Oruc lives with haemophilia A in Turkey.Novo Nordisk has
194、a long-standing legacy of pioneering advancements in the treatment of rare blood disorders,and our pipeline is primed to extend this tradition.In haemophilia A,our investigational treatment Mim8 represents an optimised therapeutic approach that could redefine the standard of care for patients worldw
195、ide,while a novel oral Factor VIIIa mimetic could be on the horizon with Inno8.Traditional treatments for haemophilia A often require intravenous infusions and cumbersome administration procedures,posing a significant burden for patients.Mim8 offers a promising alternative,administered subcutaneousl
196、y in a weekly,bi-weekly or monthly dose.It mimics the function of missing clotting Factor VIII(FVIII)by bridging Factor IXa and Factor X to restore the bodys ability to form blood clots.Mim8 is currently pending submission for regulatory review.Inno8 holds the potential to become the first-ever oral
197、 treatment for haemophilia A.Inno8 is a small antibody fragment that like Mim8 mimics FVIIIa function,but the size of the molecule is small enough to enable oral absorption.The Inno8 development programme is focused on a fast-to-market approach with overlapping clinical trials,seeking to provide a c
198、onvenient and efficacious alternative to regular infusions.We have also partnered with a pioneering biotech firm,2seventy bio,to develop a groundbreaking gene editing treatment for haemophilia A.This collaboration which was initiated in 2019,extended in 2022 and resulted in the acquisition of the me
199、gaTAL technology platform in 2024 aims to correct the clotting factor deficiency in patients,potentially eliminating the need for regular treatments.Our efforts extend beyond haemophilia to haemoglobinopathies,a group of inherited genetic blood disorders affecting the structure or production of the
200、haemoglobin molecule.Here,we are building a research portfolio to address the underlying disease pathophysiology.We are utilising our innovative technology platforms to restore red blood cell health and reduce inflammation and organ damage.Etavopivat,an investigational oral once-daily therapeutic de
201、veloped to improve anaemia and red blood cell health in people with sickle cell disease(SCD),is at the forefront of our efforts in this area.Etavopivat was acquired as part of the deal that brought Forma Therapeutics in-house back in 2022,and is currently in a phase 3 clinical trial in adolescents a
202、nd adults with SCD,and a phase 2 trial for people with transfusion-dependent SCD and thalassemia,another hereditary haemoglobinopathy disorder.Results from the phase 2 part of the HIBISCUS trial programme were presented at the Annual Meeting of the American Society of Hematology in 2024,and indicate
203、 that etavopivat has the potential to improve haemoglobin levels and reduce the incidence of vaso-occlusive crises compared to placebo severe pain caused when blood vessels are blocked and deprive tissues of oxygen in people with SCD.22Annual review /Strategic Aspirations /Innovation and therapeutic
204、 focusAnnual review /Strategic Aspirations /Innovation and therapeutic focusRARE DISEASEOBESITYDIABETESCARDIOVASCULAR&EMERGING THERAPY AREASProjectIndication DescriptionPhaseIcoSemaNN1535T2D1A combination of GLP-12 receptor agonist semaglutide and insulin icodec intended for once-weekly subcutaneous
205、 treatment.Icodec NN1436 T1D3 and T2D A long-acting basal insulin analogue intended for once-weekly subcutaneous treatment.CagriSema NN9388T2DA combination of amylin analogue cagrilintide and GLP-1 receptor agonist semaglutide intended for once-weekly subcutaneous treatment.OW GIP4/GLP-1NN9541T2DA d
206、ual GLP-1/GIP receptor agonist intended for once-weekly subcutaneous treatment.GELANN9506T2DA collaboration with GE Healthcare,using ultrasound for once-monthly treatment.AmycretinNN9490T2DA unimolecular long-acting GLP-1 and amylin receptor agonist intended for once-daily oral treatment and once-we
207、ekly subcutaneous treatment.PumpsulinNN1471T1DA novel insulin analogue for use in closed loop pump systems.DNA immuno therapyNN9041T1DA novel plasmid encoding pre-proinsulin,TGF5-beta1,IL6-10 and IL-2 intended for subcutaneous treatment.OW Oral SemaglutideNN9904T2DAn oral version of the GLP-1 recept
208、or agonist intended for once-weekly treatment.GSI7 NN1644T1DAn injectable glucose sensitive insulin intended for once daily treatment.ProjectIndication DescriptionPhaseOral SemaglutideNN9932ObesityA long-acting GLP-1 receptor agonist,25 mg and 50 mg,intended for once-daily oral treatment.Semaglutide
209、 7.2 mg NN9536ObesityA long-acting GLP-1 receptor agonist,7.2 mg,intended for once-weekly subcutaneous treatment.CagriSemaNN9838ObesityA combination of amylin analogue cagrilintide and GLP-1 receptor agonist semaglutide intended for once-weekly subcutaneous treatment.GELANN9505ObesityA collaboration
210、 with GE Healthcare,using ultrasound for once-monthly treatment.MonlunabantNN9440ObesityCB-18 receptor inverse agonist intended for once-daily oral treatment.Cagrilintide NN9833ObesityAn amylin analogue intended for once-weekly subcutaneous treatment.Amycretin NN9487 ObesityA unimolecular long-actin
211、g GLP-1 and amylin receptor agonist intended for once-daily oral treatment and once-weekly subcutaneous treatment.INV-347NN9441ObesityCB-1 receptor inverse agonist intended for once-daily oral treatment.OW GIP/GLP-1NN9542ObesityA dual GLP-1/GIP receptor agonist intended for once-weekly subcutaneous
212、treatment.TripleNN9662ObesityTri-agonist.Amylin 355NN9638ObesityAmylin analogue developed for once-weekly subcutaneous treatment.ProjectIndicationDescriptionPhaseMim8 NN7769Haemophilia A w/wo inhibitorsA next generation FVIIIa mimetic bispecific antibody intended for subcutaneous prophylaxis for hae
213、mophilia A.Etavopivat NN7535Sickle cell diseaseA second-generation small molecule PKR9-activator intended for once-daily oral treatment.Etavopivat NN7536ThalassemiaA second-generation small molecule PKR-activator intended for once-daily oral treatment.NDecNN7533Sickle cell diseaseAn oral combination
214、 of decitabine and tetrahydrouridine.The project is developed in collaboration with EpiDestiny.TMPRSS2 RNAi10Hereditary haemo-chromatosisSmall interfering RNA intended for once every 1 to 3 months subcutaneous treatment.Inno8NN7441Haemophilia A w/wo inhibitorsAn antibody intended for oral administra
215、tion.ProjectIndicationDescriptionPhaseZiltivekimab NN6018CKD11 ASCVD12AMI13HFpEF14A once-monthly monoclonal antibody intended for inhibition of IL-6 activity.Coramitug NN6019CVD15An anti-amyloid immunotherapy intended for intravenous treatment.CM4HF NN9003CVDAn investigational cell therapy intended
216、for restoring heart function in people with chronic heart failure.Anti-ANGPTL3 mAb NN6491CVDAn ANGPTL316 neutralising sweeping antibody intended for once-monthly subcutaneous treatment.Semaglutide NN6535AlzheimersA long-acting GLP-1 receptor agonist intended for once-daily oral or once-weekly subcut
217、aneous treatment.Semaglutide NN9931MASH17A long-acting GLP-1 receptor agonist intended for once-weekly subcutaneous treatment.CagriSema NN9588MASHA combination of amylin analogue cagrilintide and GLP-1 analogue semaglutide intended for once-weekly subcutaneous treatment.ZalferminNN9500MASHA long-act
218、ing FGF2118 analogue intended for once-weekly subcutaneous treatment.CDR132LNN6706Heart failureAn RNA19-based oligonucleotide inhibitor developed for once-monthly intravenous treatment.LXRa20 NN6582MASHA siRNA21 targeting LXRa intended for once-monthly subcutaneous treatment.MARC122 NN6581MASHA siRN
219、A molecule targeting MARC1 intended for once-monthly subcutaneous treatment.SC4PD NN9001Parkinsons Cryopreserved cell therapy developed for disease modifying treatment.DCR-XDHNN4004GoutAn RNA-based oligonucleotide intended for subcutaneous treatment.Ventus NLRP3i23NN6022CVDSmall molecule NLRP3 inhib
220、itor intended for once-daily oral treatment.CNP HFNN6537Heart failureC-type natriuretic peptide intended for once-weekly subcutaneous treatment.PD-L124 NN4003OncologyA PD-L1 GalXC-derived lipid conjugate intended for once-monthly subcutaneous treatment.STAT3 NN4002OncologyA GalXC-derived lipid conju
221、gate one-time subcutaneous treatment.1.T2D:Type 2 diabetes.2.GLP-1:Glucagon-like peptide-1.3.T1D:Type 1 diabetes.4.GIP:Gastric inhibitory polypeptide.5.TGF:Transforming growth factor.6.IL:Interleukin.7.GSI:Glucose-sensitive insulin.8.CB-1:Cannabinoid receptor-1.9.PKR:Pyruvate kinase-R.10.RNAi:Ribonu
222、cleic acid interference.11.CKD:Chronic kidney disease.12.ASCVD:Atherosclerotic cardiovascular disease.13.AMI:Acute miocardial infarction.14.HFpEF:Heart failure with preserved ejection fraction.15.CVD:Cardiovascular disease.16.ANGPTL3:Angiopoietin-like 3.17.MASH:Metabolic dysfunction-associated steat
223、ohepatitis.18.FGF21:Fibroblast growth factor 21.19.RNA:Ribonucleic acid.20.LXRa:Liver X receptor alpha.21.siRNA:Small interfering RNA.22.MARC1:Mitochondrial amidoxime-reducing component 1.23.NLRP3i:NOD-like receptor protein 3 inhibitor.24.PD-L1:Programmed death ligand 1.Phase 1Phase 2Phase 3Submissi
224、on and/or approval Status in 2023Progress in 2024Pipeline overview23RARE DISEASEOBESITYDIABETESCARDIOVASCULAR&EMERGING THERAPY AREASRegulatory events Awiqli,once-weekly insulin icodec,was approved by the EMA(European Medicines Agency)and PMDA(Pharmaceuticals and Medical Devices Agency)for the treatm
225、ent of T2D and T1D and by the CDE(Center for Drug Evaluation)for the treatment of T2D.Icodec received a complete response letter from the FDA(Food and Drug Administration).Rybelsus(oral semaglutide)received approval by the EMA and the FDA for three formulation changes of tablets(1.5 mg,4 mg,9 mg).Oz
226、empic label expansion was approved by the EMA to reflect the reduction in kidney disease related events in people with T2D based on FLOW results.FLOW results were submitted for Ozempic(semaglutide injection,1 mg)to FDA,PMDA and CDE for the treatment of chronic kidney disease in patients with T2D.Ico
227、Sema was submitted to the EMA and CDE for initial marketing authorisation for the treatment of T2D.Zegalogue(dasiglucagon)was approved by the EMA for treating severe hypoglycaemia(low blood glucose levels)in adults and children from 6 years.DuraTouch device has received the CE(Conformite Europenne)m
228、ark in all countries of the European union.Clinical progress Phase 3a trial programme,COMBINE,investigating once-weekly IcoSema in people with T2D was completed.Phase 3a trials,REIMAGINE 1 and 3,investigating CagriSema as monotherapy and as add-on to insulin in people with T2D respectively were init
229、iated.Phase 3b trials of the REIMAGINE programme comparing CagriSema(2.4/2.4 mg)vs tirzepatide(15 mg)and comparing CagriSema(1/1 mg)vs tirzepatide(5 mg)in patients with T2D were initiated.Phase 3b trials,ONWARDS 8 and 10,investigating icodec in people with T2D were initiated.Phase 3b trial,ONWARDS 9
230、,investigating icodec in insulin-naive people with T2D was completed.Phase 3b trial,COMBINE 4,investigating IcoSema vs glargine in a post OAD(oral anti-diabetic)population was initiated.Phase 3b CVOT(cardiovascular outcomes trial),SOUL,investigating Rybelsus,oral semaglutide 14 mg,on cardiovascular
231、outcomes in people with T2D and established cardiovascular disease and/or chronic kidney disease was completed.Phase 3b trial,STRIDE,investigating semaglutide subcutaneous 1.0 mg in people living with T2D and peripheral arterial disease was completed.Phase 3b outcomes trial,FLOW,investigating semagl
232、utide sc.1.0 mg in people living with T2D and chronic kidney disease was completed.Phase 2 programme investigating OW GIP/GLP-1 in people living with chronic kidney disease and a dose finding study in people living with diabetes were initiated.Phase 2 trial,a dose finding trial,investigating subcuta
233、neous amycretin in people living with diabetes was initiated.Phase 2 trial investigating CagriSema in people living with T2D and chronic kidney disease was initiated.Phase 1/2,a first in human dose and multiple dose trial,investigating DNA immunotherapy in development for T1D was completed.Phase 1 t
234、rial investigating GSI in people living with T1D was initiated.Once-monthly GIP/GLP-1 developed for glycaemic control in people with T2D was terminated.Regulatory events Wegovy was approved by the FDA to reduce the risk of major cardiovascular events(MACE)and EMA adopted a positive opinion to reflec
235、t risk reduction of major cardiovascular events in people with overweight or obesity and established cardiovascular disease in the label based on SELECT CVOT results.Wegovy was approved by the CDE for weight management in people living with overweight or obesity.Wegovy label expansion was approved b
236、y the EMA to reflect the reduction in symptoms and improved physical limitations and exercise function in people with obesity-related heart failure with preserved ejection fraction(HFpEF)based on STEP-HFpEF results.Wegovy label expansion was approved by the EMA to reflect the reduction of pain and i
237、mproved physical function related to knee osteoarthritis in people living with obesity based on the results of the STEP 9 trial.Clinical progress Phase 3a trial,REDEFINE 1,investigating efficacy and safety of cagrilintide(2.4 mg)in combination with semaglutide(2.4 mg)in people with overweight or obe
238、sity was completed.The extension study of REDEFINE 1 is ongoing.Phase 3b trial,REDEFINE 9,investigating CagriSema (1.7 mg/1.7 mg)and CagriSema(1.0 mg/1.0 mg)effects on weight reduction in people with overweight or obesity was initiated.Phase 3b trial,OASIS 4,investigating oral semaglutide(25 mg)weig
239、ht loss in people living with overweight with weight-related comorbidities or obesity was completed.Phase 3b trials,STEP UP and STEP UP T2D,investigating semaglutide(7.2 mg)on weight loss were completed.Phase 2a trial investigating monlunabant(INV-202)in patients with obesity and metabolic syndrome
240、has been completed.Phase 1 first in human dose trial investigating amylin 355 in people with overweight or obesity was initiated.Phase 1 trial studying the safety and tolerability of oral amycretin was completed.Phase 1b trial,a dose-finding study investigating oral amycretin was initiated.Phase 1b/
241、2a trial,investigating subcutaneous amycretin was completed.Phase 1 Triple first in human trial was initiated.Regulatory events Esperoct was approved by the CDE for treatment and prevention or reduction of number of bleeding episodes in people with haemophilia A.Alhemo(concizumab)was approved by the
242、 EMA and FDA for the treatment of haemophilia A and B disease with inhibitors and by the PMDA for the treatment of haemophilia A and B disease with and without inhibitors.Clinical progress Phase 3a trials,FRONTIER 2 and 5,investigating once-weekly to once-monthly subcutaneous Mim8 in people aged 12
243、or older with haemophilia A were completed.Phase 3a trial,HIBISCUS 2,investigating etavopivat in adolescents and adults living with sickle cell disease was initiated.Phase 2 trial investigating etavopivat on cerebral haemodynamic response in children with sickle cell disease was initiated.Phase 2 tr
244、ials investigating etavopivat for the treatment of myelodysplastic syndromes(MDS)have been closed.The MDS programme was terminated.Phase 1 first in human trial investigating Inno8 was initiated.Phase 1 trial investigating TMPRSS6 RNAi in people living with hereditary haemochromatosis was initiated.C
245、linical progress Phase 3a trial,ESSENCE,investigating semaglutide subcutaneous 2.4 mg efficacy and safety in people with MASH completed its primary interim data readout,the trial is continuing to investigate the effect on outcomes in people with MASH.Phase 3a trial,CLARION-CKD,investigating ocedureo
246、ne in patients with uncontrolled hypertension and advanced chronic kidney disease was terminated.The ocedureone programme was terminated.Phase 3a CVOT,ARTEMIS,investigating the effect of ziltivekimab on outcomes in people with acute myocardial infarction was initiated.Phase 3a trial,ATHENA,investiga
247、ting the effect of ziltivekimab on functional outcomes in HFpEF patients was initiated(SPA).Novo Nordisk acquired Cardior with lead asset CDR132L.Phase 1 trial investigating VAP-1i,a GLP-1/GIP receptor agonist for people living with MASH was terminated.Phase 1 first in human trial investigating Vent
248、us NRLP31 was completed.Phase 1 trial investigating DCR-XHD in people living with refractory gout was initiated.Phase 1 first in human and single ascending dose trial investigating CNP HF was initiated.Phase 1 trial,investigating safety and tolerability of PD-L1 in adult oncology patients with solid
249、 tumours refractory to standard therapy was initiated.Research and development progress24Annual review /Strategic Aspirations /Innovation and therapeutic focus1.This overview does not include products whose sales represent less than 0.5%of Novo Nordisks total sales.2.Patent status varies from countr
250、y to country.The figures in the table are based on Germany.3.For Ozempic in Canada,regulatory data protection applies until 2026.4.Modern insulins are NovoRapid(NovoLog),NovoMix 30(NovoLog Mix 70/30)and Levemir.5.Formulation patent;active ingredient patent has expired.Patent status for products with
251、 marketing authorisationProductUSChinaJapanEurope2Ozempic32032202620312031Human insulin and Modern insulins4ExpiredExpiredExpiredExpiredRybelsus2032202620312031Tresiba2029Expired20272028VictozaExpiredExpiredExpiredExpiredRyzodeg2029ExpiredExpired2028Xultophy2029ExpiredExpired2028Fiasp203052030520305
252、20305ProductUSChinaJapanEurope2Wegovy2032202620312031SaxendaExpiredExpiredExpiredExpiredProductUSChinaJapanEurope2NovoSevenExpiredExpiredExpiredExpiredNorditropin(SimpleXx)ExpiredExpiredExpiredExpiredEsperoct2032202920342034The patent expiry dates for products with marketing authorisation1 are shown
253、 in the tables on the right.The dates provided are for expiry in the US,China,Japan and Europe of patents on the active ingredient,unless otherwise indicated,and include actual and estimated extensions of patent term,when applicable.For several products,in addition to the active ingredient patent,No
254、vo Nordisk holds other patents on manufacturing processes,formulations or uses that may be relevant for exclusivity beyond the expiration of the active ingredient patent.Furthermore,regulatory data protection and/or orphan exclusivity may apply.25Annual review /Strategic Aspirations /Innovation and
255、therapeutic focusCOMMERCIAL EXECUTIONSafeguarding supply and improving access across expanding marketsBalancing the growing needs of our patients with effective management of our resources is key to how we operate.As global demand increases we have refined our portfolio strategy to maximise the reac
256、h and impact of our treatments.This includes efforts to optimise our diabetes portfolio by gradually phasing out some of our older insulin products to free up manufacturing capacity and resources across our supply chain.By doing so,we can dedicate more space in our manufacturing network to innovativ
257、e,scalable solutions and ultimately expand the reach of our life-changing innovations to millions more patients over the next decade.At the same time,we are striving to provide those who are impacted by the changes to our portfolio with access to alternative treatment options,either from Novo Nordis
258、k or other companies.We are working closely with local health authorities and the medical community in affected markets to develop new access initiatives for at-risk individuals.Furthermore,our extensive range of partnership programmes including iCARE and our Access to Insulin Commitment continue to
259、 provide access to affordable care for vulnerable populations living in low-and middle-income countries.We are also increasing our production capacity through site expansions and acquisitions.A significant milestone in 2024 was the acquisition of three fill-finish sites previously run by the global
260、contract manufacturing and development organisation Catalent Inc.This move will enable us to expand our manufacturing capacity and provide future optionality and flexibility for our existing supply network,while complementing our significant ongoing internal supply chain expansions.The unprecedented
261、 scale of our capital expenditure,which includes record investments in the expansion of existing production sites,underscores our commitment to meeting the growing demand for our medicines.In 2024,work continued on major expansions of our production sites in Denmark,France,Brazil,China and the US in
262、vestments that will ultimately enable us to reach millions more people worldwide with our innovations.Ensuring uninterrupted access to treatment options for people already using Novo Nordisk medicines also remains a top priority.By adopting clear prioritisation principles,we are focusing on the resp
263、onsible and equitable launch and distribution of new and existing products across geographies and patient groups.This includes allocating a proportion of Wegovy volumes in every new launch market for people with a high medical need and low socioeconomic status.Amid escalating diabetes and obesity cr
264、ises,Novo Nordisk is experiencing unprecedented global demand for our life-changing medicines.With mounting evidence of the broad systemic impact and societal value of our GLP-1-based treatments,we have developed innovative commercial strategies to safeguard patient access and strengthen supply chai
265、n resilience worldwide.Strategic Aspirations 20251 Strengthen Diabetes leadership aim at global value market share of more than 1/32 More than DKK 25 billion in Obesity sales by 20253 Secure a sustained growth outlook for Rare disease26Annual review /Strategic Aspirations /Commercial execution605040
266、302029.9%43.3%52.8%31.8%44.2%54.9%33.7%33.7%43.6%43.3%54.8%55.1%2021202320242022250200150100500202420212023202220%13%29%14%Ozempic sales uptake further strengthens our leadership in diabetes care Demand for Novo Nordisks GLP-1-based medicines,particularly Ozempic,continued to soar throughout 2024,re
267、flecting the growing global prevalence of diabetes.Administered as a once-weekly injection for the treatment of type 2 diabetes,Ozempic maintains its position as the worlds biggest-selling diabetes medicine,backed by its proven efficacy in controlling blood sugar and reducing body weight,as well as
268、a growing body of evidence demonstrating broader cardiometabolic benefits.Over the past year alone,the clinical profile of Ozempic has been further boosted by data demonstrating a reduction in the risk of kidney disease progression in people with type 2 diabetes and chronic kidney disease,as well as
269、 functional improvements in people with type 2 diabetes and symptomatic peripheral artery disease vs placebo.Now available in more than 70 markets,Ozempic sales have been central to the continued growth in sales of our diabetes products.Our strategic aspiration to secure a value market share of at l
270、east one-third by 2025 has already been achieved,and the continued uptake of Ozempic across launch markets has enabled us to maintain a value market share of 33.7%in 2024.This demand has been fuelled by a broader acceptance and understanding of the importance of GLP-1-based therapies among healthcar
271、e professionals,patients and payers as a cornerstone of effective diabetes care and management.Novo Nordisk is not the only healthcare company investing in the growth and development of the GLP-1 segment,and competition has increased significantly over the past year.Nevertheless,we remain the market
272、 leader in the diabetes GLP-1 space with a value share of 55.1%,a slight increase compared to 2023 when our value share stood at 54.8%.Despite the sales penetration of Ozempic,high demand has also posed challenges,necessitating strategic decisions to prioritise distribution to regions and patient gr
273、oups with the most pressing needs.We have also continued to invest heavily in expanding production capacity,seeking to stabilise supply and ensure that Ozempic remains accessible to the growing number of patients who have already initiated treatment.Through our industry-leading portfolio,relentless
274、focus on innovation and robust pipeline of next-generation treatments,we remain well-positioned to maintain and enhance our leadership position in diabetes care.Diabetes value market share(%)GLP-1 Insulin Total diabetesSource:IQVIA MAT,Nov 2024.Diabetes sales(DKK billion)Sales as reported Growth at
275、CER“Demand has been fuelled by a broader acceptance and understanding of the importance of GLP-1-based therapies”27Annual review /Strategic Aspirations /Commercial executionAwiqli approval underscores our continuing commitment to insulinOur company is built upon a century-long legacy of innovation i
276、n diabetes care,and we are still pushing boundaries as we search for new breakthroughs in this ever-evolving space.These efforts are exemplified by the launch of Awiqli the worlds first once-weekly basal insulin in China,Germany and Canada.Awiqli represents a critical and innovative addition to our
277、diabetes portfolio and a key milestone for patients seeking to reduce some of the challenges of diabetes management particularly the burden of multiple injections.Its approval in the EU was based on phase 3a clinical trial results demonstrating superior blood sugar reduction and superior time in ran
278、ge(time spent within the recommended blood sugar range),compared with daily basal insulin in people living with type 2 diabetes not previously treated with insulin.Trial data also showed low rates of clinically significant or severe hypoglycaemia less than one event per patient-year of exposure with
279、 no statistically significant difference compared to daily basal insulin in insulin nave people living with type 2 diabetes.However,the therapys journey to market in the US has been more challenging,with the US Food and Drug Administration(FDA)issuing a Complete Response Letter(CRL)in July 2024.This
280、 followed a meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee in May 2024,where a panel of independent scientific experts discussed the benefit-risk of once-weekly insulin icodec in type 1 diabetes.The panel determined that the data available were not sufficient to conclude on
281、 a positive benefit-risk in type 1 diabetes.In the CRL,the FDA requests more information relating to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed.The CRL did not mention the use of once-weekly insulin icodec in type 2 diabetes.Nov
282、o Nordisk is evaluating the content of the CRL and will work closely with the FDA to fulfil the requests.Despite this setback in the US,the rollout of Awiqli in other major markets underscores our continuing commitment to insulin innovation more than 100 years after our founders first commercialised
283、 production of this life-saving medicine.Kyle Sam lives with type 2 diabetes and is part of the DUDES Club,a brotherhood to support mens health and wellbeing in British Columbia,Canada.“Awiqli represents a critical and innovative addition to our diabetes portfolio and a key milestone for patients se
284、eking to reduce some of the challenges of diabetes management”28Annual review /Strategic Aspirations /Commercial execution806040200202120232024202255%154%57%84%20202025203520306050403020Wegovy maintains market-leading position in increasingly dynamic sectorThe past year has been transformative for t
285、he burgeoning obesity market,marked by increasing competition and soaring demand for GLP-1 receptor agonists and other incretin-based therapies.Wegovy,our flagship obesity therapy,has been at the forefront of this competitive landscape,maintaining its market-leading position despite new entrants to
286、the segment.Following its initial launch in the US,Wegovy is now available in more than 15 markets worldwide.As the obesity market continues to grow worldwide,so does the demand for Wegovy.This is driven by the rising global prevalence of obesity which has more than tripled over the past 50 years an
287、d a broader shift in the perception of treatment.Once considered a lifestyle issue,obesity is now widely recognised as a serious chronic disease that requires medical intervention.We have responded by investing heavily in scaling up our production capacity and carefully prioritising launches and dis
288、tribution.Our expanding global production network is operating around the clock to ensure a stable and consistent supply of Wegovy and a proportion of Wegovy volumes is being allocated in every launch market for people with a high medical need and low socioeconomic status.The continued success of We
289、govy is underpinned by its clinical profile as the worlds first weight management therapy also approved to reduce the risk of major adverse cardiovascular events a key differentiator in an increasingly competitive segment.This has enabled us to capture much of the growth to date in a rapidly-expandi
290、ng and dynamic market,helping us to build on our position of strength and reputation as first-movers in the space following the success of our first-generation GLP-1-based therapy,Saxenda.Despite advancements in treatment and growing acceptance of obesity as a serious chronic disease,significant unm
291、et needs remain.Many people living with obesity still lack access to effective therapies,and there is a clear need for continued innovation to develop treatments that can deliver greater efficacy and additional benefits.Moreover,there is a need for more holistic,preventive approaches that can addres
292、s the multifaceted nature of obesity including behavioural,psychological and environmental factors.Novo Nordisk is dedicated to addressing these unmet needs through a steadfast commitment to innovation.Our obesity pipeline includes numerous promising candidates aiming to further reduce the burden of
293、 obesity and related conditions on patients and healthcare systems alike.By leveraging our expertise in GLP-1-based therapies and exploring new therapeutic avenues,we are well-placed to continue leading the way in obesity treatment.Adults with overweight or obesity as a proportion of alladults globa
294、lly (%)ObesitySource:World Obesity Atlas 2024.Obesity sales(DKK billion)Sales as reported Growth at CER42%50%54%46%29Annual review /Strategic Aspirations /Commercial executionElroy Spoonface Powell lives with obesity in the UK.The robust clinical profile of our market-leading weight loss therapy,Weg
295、ovy,has been further validated after regulatory bodies approved label expansions acknowledging its efficacy in mitigating cardiovascular risks.These updates highlight the extensive cardiometabolic benefits of our market-leading GLP-1-based therapy,extending beyond weight reduction.The new indication
296、s are based on robust clinical evidence from key trial programmes SELECT and STEP HFpEF.Data from SELECT demonstrated that Wegovy reduced the risk of major adverse cardiovascular events in people with overweight or obesity and established cardiovascular disease,on top of cardiovascular standard of c
297、are treatments vs placebo.Findings from the STEP HFpEF trials,meanwhile,showed that Wegovy reduced symptoms of heart failure and physical limitations in people with obesity and heart failure with preserved ejection fraction(HFpEF)vs placebo.These data add to a growing body of evidence showcasing sem
298、aglutides potential to address critical unmet needs in cardiovascular health.By broadening the approved uses of Wegovy and helping to differentiate the treatment in an increasingly competitive market,we are aspiring to both strengthen our leadership position in obesity and enhance our impact on broa
299、der public health.Wegovy label expansions underscore broader cardiometabolic benefits2024 has been a year of significant progress in our rare disease portfolio,building on our strong legacy of innovation in rare blood and endocrine disorders.With the pending submission of Mim8,first launches of Alhe
300、mo and continued rollout of Sogroya,we are building on a return to growth for our Rare Disease franchise following a positive year in which overall sales increased 9%at constant exchange rates(CER).Sales of our rare endocrine disorder products increased by 31%at CER over the course of the year,mainl
301、y driven by the rollout of Sogroya the worlds first once-weekly treatment for both children and adults with growth hormone deficiency.Sogroya is now available in seven countries,including the US.In rare blood disorders,phase 3 clinical trials have demonstrated the transformative potential of Mim8 in
302、 reducing bleeds.The investigational therapy is designed to mimic the activity of Factor VIIIa,the clotting protein missing or defective in people with haemophilia A.Alhemo addresses significant unmet needs in haemophilia A and B with inhibitors the latter being an area with very limited treatment o
303、ptions.Administered once-daily by subcutaneous injection,the therapy offers routine treatment to prevent bleeding in a prefilled pen device.Alhemo is now approved in several markets worldwide,including the US and EU.Gearing up for new launches in our rare disease portfolio20212022202320242520151050R
304、are disease sales(DKK billion)4%-15%9%1%Sales as reported Growth at CER“Alhemo addresses significant unmet needs in haemophilia A and B with inhibitors the latter being an area with very limited treatment options”“These data add to a growing body of evidence showcasing semaglutides potential to addr
305、ess critical unmet needs in cardiovascular health”30Annual review /Strategic Aspirations /Commercial execution2021202420151050202120232024202215012510075502504%7%45%11%Unprecedented investment in production lays foundation for continued growthOver the past four years,we have more than quadrupled the
306、 global reach of our GLP-1-based medicines,increasing our volume market share in the GLP-1 segment to 63%over the same period.With demand still growing,we continued to expand our production network throughout 2024,making significant investments in capital expenditure(CapEx)and acquisitions totalling
307、 more than DKK 129 billion.Through the targeted acquisitions of brownfield sites,the strategic expansion of existing facilities,the establishment of new sites and the upscaling of our global production workforce,we are equipping ourselves to support the launch of multiple next-generation therapies a
308、nd meet the needs of millions more people worldwide.The scope of these investments is measured not only in financial terms,but also by the increased volume of active pharmaceutical ingredients(API)and the number of devices we can produce.By investing in state-of-the-art,multi-product facilities desi
309、gned to accommodate current and future products,we are laying a foundation for sustainable long-term growth.The ongoing expansions of our production sites across the globe exemplify our approach to scaling up.We are investing more than DKK 80 billion into expanding our API production capacity,includ
310、ing the construction of a new 170,000 square metre,multi-product API facility in Kalundborg,Denmark.Alongside additional expansions of sites in Denmark,France,Brazil,China and the US,these efforts will significantly enhance our ability to meet future demand across our portfolio.Our acquisition of th
311、ree new fill-finish sites at the turn of the year complements the ongoing expansion of our internal supply chain,enabling us to expand our manufacturing capacity and provide future optionality and flexibility for our existing supply network.The three former Catalent sites were acquired as part of a
312、transaction that saw Novo Holdings the holding and investment company responsible for managing the wealth and assets of the Novo Nordisk Foundation acquire the US-based contract manufacturing and development organisation.Approximately 3,200 highly skilled Catalent employees became part of Novo Nordi
313、sk under the terms of the agreement,which will ensure that existing obligations towards other customers currently being served by the three sites will be honoured.Removing bottlenecks in our existing supply chain also remains a top priority as we seek to keep pace with demand.The consolidation of ou
314、r insulin portfolio will free up vital capacity and resources for production of our next-generation innovations,while our transition towards reusable devices and once-weekly rather than once-daily formulations continues.Investments in CapEx and acquisitions related to expansion of production capacit
315、y(DKK billion)CapEx Acquisitions CapEx and acquisitions to sales ratioPeople with diabetes and obesity reached with GLP-1-based medicines(Million)Novo Nordisk1 Others2 Volume market share(%)Source:IQVIA R3M,Nov 2024.1.Includes liraglutide and semaglutide.2.Includes beinaglutide,biosimilar liraglutid
316、e,biosimilar semaglutide,dulaglutide,exenatide,lixisenatide,peg-loxenatide and tirzepatide.PRODUCTION63%55%“We are investing more than DKK 80 billion into expanding our API production capacity,including the construction of a new 170,000 square metre,multi-product API facility in Kalundborg,Denmark”4
317、x 31Annual review /Strategic Aspirations /Commercial executionFINANCIALSFinancial performanceSales increased by 25%measured in Danish kroner and by 26%at CER to DKK 290,403 million in 2024.Novo Nordisks 2024 sales and operating profit performance measured at CER were within the ranges provided in No
318、vember 2024.The effective tax rate,capital expenditure as well as depreciation,amortisation and impairment losses were all in line with the guidance.The free cash flow in 2024 was realised at DKK-14.7 billion,mainly impacted by the USD 11.7 billion acquisition price related to the three Catalent man
319、ufacturing sites.Geographic sales developmentSales in North America Operations increased by 30%in both Danish kroner and at CER.Sales in International Operations increased by 17%measured in Danish kroner and by 19%at CER.Sales in EMEA increased by 19%in both Danish kroner and at CER.Sales in Region
320、China increased by 11%measured in Danish kroner and by 13%at CER.Sales in Rest of World increased by 19%measured in Danish kroner and by 23%at CER.Sales development across therapeutic areas Sales in Diabetes care increased by 19%measured in Danish kroner and by 20%at CER.Sales of Obesity care produc
321、ts,Wegovy and Saxenda,increased by 56%measured in Danish kroner and by 57%at CER.Sales of Rare disease products increased by 9%in both Danish kroner and at CER.In the following sections,unless otherwise noted,market data are based on moving annual total(MAT)from November 2023 and November 2024 provi
322、ded by the independent data provider IQVIA.2024 performance and 2025 outlook20222021202120232022202420232024Financial performance(DKK billion)Sales by therapeutic area(DKK billion)North America Operations net sales International Operations net sales Growth at CER Diabetes care Obesity care Rare dise
323、ase Growth at CER30025020015010050030025020015010050014%14%16%16%36%26%36%26%Strategic Aspirations 20251 Deliver solid sales and operating profit growth2 Drive operational efficiencies across the value chain to enable investments in future growth assets 3 Deliver free cash flow to enable attractive
324、capital allocation to shareholders32Annual review /Strategic Aspirations /Financialsat CER to DKK 4,993 million.Novo Nordisk is working on gradually re-establishing supply of rare endocrine disorder products following a reduction of manufacturing output.Sogroya has been launched in six countries,and
325、 the initial feedback from patients and physicians is encouraging.Rare blood disordersSales of Rare blood disorder products increased by 3%in both Danish kroner and at CER to DKK 12,138 million mainly driven by increased haemophilia B sales.Development in costs and operating profitThe cost of goods
326、sold increased by 24%measured in Danish kroner and by 25%at CER to DKK 44,522 million,resulting in a gross margin of 84.7%measured in Danish kroner,compared with 84.6%2023.The increase in gross margin mainly reflects a positive product mix driven by increased sales of GLP-1-based treatments and a po
327、sitive price impact due to gross-to-net sales adjustments in the US.This is partially countered by costs related to ongoing capacity expansions.Sales and distribution costs increased by 9%measured in Danish kroner and by 10%at CER to DKK 62,101 million.The increase in costs is driven by both North A
328、merica Operations and International Operations.In North America Operations,the cost increase is mainly driven by promotional activities related to Wegovy.In International Operations,the increase is mainly related to Obesity care market development activities and Wegovy launch activities as well as p
329、romotional activities for GLP-1 diabetes products.The increase in sales and distribution costs is negatively impacted by adjustments to legal provisions in 2023.Sales and distribution costs amounted to 21.4%as a percentage of sales.Research and development costs increased by 48%in both Danish kroner
330、 and at CER to DKK 48,062 million compared to 2023,mainly reflecting increased late-stage clinical trial activity,increased early research activities as well as impairment losses related to intangible assets.Research and development costs amounted to 16.6%as a percentage of sales.Administration cost
331、s increased by 9%in both Danish kroner and at CER to DKK 5,276 million.Other operating income and expenses(net)showed a loss of DKK 2,103 million compared to an income of DKK 119 million in 2023.Diabetes care Sales in Diabetes care increased by 19%measured in Danish kroner and by 20%at CER to DKK 20
332、6,618 million driven by growth of GLP-1-based products and insulins.Novo Nordisks global diabetes value market share remains unchanged over the last 12 months at 33.7%.The market share was driven by market share gains in North America Operations,offset by a market share decline in International Oper
333、ations.GLP-1-based therapy for type 2 diabetesSales of GLP-1-based products for type 2 diabetes(Rybelsus,Ozempic and Victoza)increased by 21%measured in Danish kroner and by 22%at CER to DKK 149,125 million.The estimated global GLP-1 share of total diabetes prescriptions has increased to 6.7%compared with 6.0%12 months ago.Novo Nordisk is the global market leader in the GLP-1 segment with a 55.1%v