← Back to NVO filing summaryThis is the extracted source text from the SEC filing. Formatting may differ from the original document.
New accounting pronouncements
Reference is made to Note 1.2 ‘Changes in accounting policies and disclosures’ in the consolidated financial statements in our Annual Report 2025.
A. OPERATING RESULTS
Reference is made to the section ‘Forward-looking statements’ on page 17-18 of our Annual Report 2025 and the discussion under the caption ‘Risk factors’ under Item 3 of this Form 20-F. Further reference is made to ‘Risk management’ on pages 41-42 of our Annual Report 2025.
The information in this section is based on our Annual Report 2025 and should be read in conjunction with such report. The analysis and discussion included in such report is primarily based on the Company's consolidated financial statements which are prepared in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board.
2025 compared with 2024
The following portions of our Annual Report 2025 constitute the Board of Directors’ and Executive Management’s discussion and analysis of results of operations (incorporated herein by reference): ‘Introducing Novo Nordisk’ (pages 3-11) and ‘2025 performance and 2026 outlook’ (pages 14-17).
2024 compared with 2023
For a discussion of our results of operations for 2024 compared with 2023, see ‘Item 5.A. Operating Results, 2024 Compared with 2023‘ included in our 2024 Annual Report on Form 20-F (File No. 333-82318) filed with the SEC on 5 February 2025 (hereafter "Annual Report 2024").
Segment information
Effective 1 January 2025, Novo Nordisk reorganised its geographical areas. Reference is made to Note 2.2 ‘Segment information’ in the consolidated financial statements in our Annual Report 2025 for details on segmented results.
Sales in Russia and Ukraine constituted less than 1% of Novo Nordisk's global sales in 2025. Novo Nordisk's factory in Russia is still operating to supply insulin to patients in Russia only. While Novo Nordisk maintains supply of medicine in Russia to ensure that more than 700,000 patients can continue their treatment with essential medication, Novo Nordisk has ceased the launch of new medications and has suspended further clinical investments in Russia. Novo Nordisk has, to the extent possible, continued supply of medicines in Ukraine and Novo Nordisk medicines are currently available in more than 90% of Ukraine.
11
Novo Nordisk Form 20-F 2025
ITEM 5 OPERATING AND FINANCIAL REVIEW AND PROSPECTS
Foreign currencies
Reference is made to Note 4.4 ‘Financial risks’ in the consolidated financial statements in our Annual Report 2025 and for further description of foreign currency exposure and hedging activities, reference is made to the description of financial instruments in Note 4.5 ‘Derivative financial instruments’ in the consolidated financial statements in our Annual Report 2025.
Governmental policies
Please refer to pages 12-34 ‘Strategic Aspirations’ of our Annual Report 2025 and Item 4 hereof.
Off-balance sheet arrangements
Reference is made to Note 4.4 ‘Financial risks’ in the consolidated financial statements and Note 5.2 ‘Commitments’ in the consolidated financial statements in our Annual Report 2025.
B. LIQUIDITY AND CAPITAL RESOURCES
Novo Nordisk maintains a centralised approach to the management of the Group’s financial risks. The overall objectives and policies for Novo Nordisk’s financial risk management are outlined in the Novo Nordisk Treasury Policy, which is approved by the Board of Directors. The Treasury Policy governs the Group’s use of financial instruments. For further information, reference is made to Item 11.
Financial resources
Reference is made to ‘Cash flow statement’ on page 84 and ‘Balance sheet’ on page 85 of our Annual Report 2025. In addition, Novo Nordisk has obtained a credit rating from two independent external rating agencies.
Novo Nordisk believes its financial resources are sufficient to meet its requirements for at least the next 12 months.
Cash flow in 2025, 2024 and 2023
Reference is made to ’Cash flow statement' on page 84 of our Annual Report 2025.
The most significant source of cash flow from operating activities is sales of Obesity and Diabetes care and Rare disease products. Generally, other factors that affect operating earnings, such as pricing, volume, product mix, costs and exchange rates, also have an impact on realised cash flow from operating activities. Except as disclosed in Note 4.8 'Financial assets and liabilities' in the consolidated financial statements in our Annual Report 2025, there are no material restrictions on the ability of subsidiaries with material cash amounts to transfer funds to the parent company, Novo Nordisk A/S.
Trade receivable programme
Trade receivable programme, as of 31 December 2025, 2024 and 2023, respectively, are shown in Note 4.4 ‘Financial risks’ in the consolidated financial statements in our Annual Report 2025.
Debt financing
Reference is made to ‘Balance sheet’ on page 85 and to Note 4.6 ‘Borrowings’ in the consolidated financial statements in our Annual Report 2025 for information on Current and Non-current debt.
Derivative financial instruments
Novo Nordisk only hedges commercial exposures, including selected business development activities (mergers and acquisitions), and consequently does not enter into derivative transactions for trading or speculative purposes. Currency hedging is done with foreign exchange forwards and foreign exchange options. Reference is made to Note 4.4 ‘Financial risks’ and Note 4.5 ‘Derivative financial instruments’ in the consolidated financial statements in our Annual Report 2025 for further information on financial instruments including currency exposure.
Commitments for capital expenditure etc.
Contractual obligations for capital expenditure and other contingent liabilities as of 31 December 2025 and 2024, respectively, are shown in Note 5.2 ‘Commitments’ in the consolidated financial statements in our Annual Report 2025.
The Executive Management of the Group believes that the obligations are covered by the Group’s financial resources as well as expected future cash flows from operating activities.
12
Novo Nordisk Form 20-F 2025
ITEM 5 OPERATING AND FINANCIAL REVIEW AND PROSPECTS
C. RESEARCH AND DEVELOPMENT, PATENTS AND LICENSES, ETC.
Novo Nordisk research and development is mainly focused on:
–Insulins, GLP-1s and other therapeutic compounds for diabetes treatment
–GLP-1s, combinations and other modes of action for obesity care
–Blood-clotting factors and other modes of action for treatment of haemophilia and other rare blood disorders
–Human growth hormone and other modes of action for treatment of growth disorders and other rare endocrine disorders
–New indications with existing assets and other modes of action for treatment of cardiovascular diseases, MASH and other serious chronic diseases related to Diabetes or Obesity
–Research technology platforms including RNAi for treatment of diseases within Obesity and Diabetes and their related comorbidities and within Rare Disease
The research activities mainly utilise biotechnological methods based on advanced protein chemistry and protein engineering. These methods have played a key role in the development of the production technology used to manufacture insulin, GLP-1, recombinant blood-clotting factors and human growth hormone. Research activities further utilise technology platforms including RNAi therapies and small molecules. Research and development activities are carried out by Novo Nordisk's research and development centres, mainly in Denmark, the United States, the United Kingdom and China. Clinical trials are carried out globally.
Novo Nordisk also enters into partnerships and licence agreements. Reference is made to Note 2.3 ‘Research and development costs’ in the consolidated financial statements in our Annual Report 2025 for research and development costs in 2025, 2024 and 2023, respectively. Novo Nordisk’s research and development organisation is comprising more than 10,000 employees as of 31 December 2025.
Research costs comprise the early stages of the drug development cycle from the initial drug discovery until the drug is ready for administration to humans. The activities initially focus on identifying a single drug candidate with a profile that will support a decision to initiate development activities. Before selection of the final drug candidate, it is tested in animals to gather efficacy, toxicity and pharmacokinetic information. Development costs are incurred from the start of phase 1, when the drug is administered to humans for the first time; these are the projects captured in the ’Pipeline overview’ (page 30 of our Annual Report 2025). The final product is developed, and subsequent clinical trials (phases 2 and 3) are conducted to further test the drug in humans, using the results from these trials to obtain marketing authorisation, permitting Novo Nordisk to market and sell the developed products. Historically, Novo Nordisk has spent approximately 70-80% of total research and development expenditures on clinical development activities, and approximately 20-30% on research activities. The split between research and development will fluctuate in individual years depending on the composition of the clinical development portfolio.
In general, Novo Nordisk expects that growth in research and development spending will follow a trend in line with or slightly above sales growth indicating that the research and development cost to sales ratio is expected to gradually increase in the foreseeable future. Thus, Novo Nordisk currently expects to modestly expand upon the current expenditure level of around 15-17% of sales in research and development activities going forward. Increased early and late-stage clinical trial activities across all therapy areas as well as increased business development activities are driving costs.
Novo Nordisk has multiple phase 3 programmes currently in progress, see the below table for the full list.
The following Novo Nordisk compounds are currently in phase 3 development or have recently been filed for regulatory approval:
COMPOUND / BRAND NAME / INDICATION Year entered into phase 3 or filed with the regulatory authorities Patent expiration
Concizumab (NN7415) / Haemophilia A and B with or without inhibitors Approved for some indications (Under the brand name Alhemo®) Regulatory submission for some indications ongoing 20341
Insulin Icodec (NN1436) / Once-weekly basal insulin analogue Approved by EU and others (Under brand name Awiqli®) Regulatory submission to US in 2025 20372
Semaglutide (oral) 25 mg and 50 mg / Obesity Approved in the US (Under the brand name Wegovy® Pill). Regulatory submission to EU and others in 2025 2032
Semaglutide 7.2 mg / Obesity Regulatory submission in 2025 2032
Cagrisema (NN9388)/ Diabetes Phase 3 initiated in 2023 2037
Cagrisema (NN9838)/ Obesity Regulatory submission in 2025 2037
13
Novo Nordisk Form 20-F 2025
ITEM 5 OPERATING AND FINANCIAL REVIEW AND PROSPECTS
Cagrilintide / Obesity Phase 3 initiated in 2025 2037
IcoSema (NN1535) / A combination of GLP-1 semaglutide and insulin icodec Regulatory submission in 2024 20372
Etavopivat (NN7535) / Second generation selective, small molecule PKR-activator intended for once-daily oral administration in sickle cell disease Phase 3 initiated in 2022 20393
Mim8 (NN7769) Regulatory submission in 2025 20404
Efruxifermin / FGF-21 treatment in MASH Phase 3 initiated in 2024 20295
Ziltivekimab (NN6018) / Cardiovascular Phase 3 initiated in 2021 20356
Ziltivekimab (NN6018) / Cardiovascular disease
Coramitug (NN6019) / Transthyretin amyloidosis Cardiomyopathy treatment Phase 3 initiated in 2025 2041
1 Current estimate United States. Key EU markets estimate 2035, Japan expiry 2034
2 Current estimate of regulatory data protection in the United States. Key EU markets and Japan estimate 2034
3 Current estimate, United States. Key EU markets and Japan estimated in 2038
4 Current estimate, United States. Key EU markets estimate 2041 and Japan estimated in 2044
5 Current estimate, United States. Key EU markets estimate 2030 and Japan estimated in 2030. Further, up to 5 years of patent term extension is available in these markets. In addition to patents, the product is eligible for Regulatory Data Protection, i.e. 10 years from market authorisation in the EU and 12 years from market authorisation in the US
6 Current estimate, United States. Key EU markets and Japan estimate 2032. In addition to patents, the product is eligible for Regulatory Data Protection, i.e. 10 years from market authorisation in the EU and 12 years from market authorisation in the US.
In determining whether or not any project or group of related projects is significant, we consider the following qualitative and quantitative criteria:
•Assessment of the unmet medical need targeted with the specific project;
•The inherent project risk including the risk of safety issues, unsatisfactory tolerability profile, limitations on the efficacy of the compound;
•Timeline for completing the clinical testing and submitting an application for approval to regulatory authorities;
•Regulatory authorities’ position towards approval and drug label;
•Changes in competitive landscape during the development and approval cycle including competing drugs being developed by others;
•Changes in medical practice during the development period;
•Position of payers, the medical society and patients towards treatment with the drug and price of the drug;
•Expected uptake in market following launch; and
•Expected net present value of the project.
In assessing the criteria listed above, we refer to ‘Risk Management’ on pages 41-42 in our Annual Report 2025. It is important to note that due to the risks and uncertainties involved in progressing through pre-clinical development and clinical trials, and the time and cost involved in obtaining regulatory approvals, we cannot reasonably estimate the nature, timing, completion dates and costs of the efforts necessary to complete the development. The nature of Novo Nordisk’s development activities is such that a compound must first be proven to work by means of multiple clinical trials, which may require treatment of thousands of patients and could take years to complete. Even if initial results of preclinical studies or clinical trial results are promising, the Company may obtain different results that fail to show the desired levels of safety and efficacy, or Novo Nordisk may not obtain applicable regulatory approval for a variety of other reasons. The compound must be approved by either the US Food and Drug Administration, the European Medicines Agency or by similar agencies around the world, each of which may have differing requirements. During each stage, there is a substantial risk that Novo Nordisk will encounter serious obstacles which will further delay us, or that the Company will not achieve its goals and, accordingly, may abandon a product in which it has invested substantial resources. Furthermore, the commercial potential of a project is dependent on the label granted by the regulatory authority upon approval. The label specifies for which indications a product is approved for, major and minor safety concerns associated with drug treatment, as well as if the drug is approved for use in combination with other types of medication. Thus a label can restrict usage substantially. Reference is made to the caption ‘Risk factors’ contained under Item 3 hereof.
Given the uncertainties related to the process of product development, during the periods presented in our 2025 Form 20-F no single project in product development was material to total R&D spend nor significant based on the qualitative and quantitative criteria.
14
Novo Nordisk Form 20-F 2025
ITEM 5 OPERATING AND FINANCIAL REVIEW AND PROSPECTS
However, during the periods presented, two groups of projects were considered significant; the Obesity and Diabetes care group and the Rare disease group.
Information related to selected research and development projects can be found under ‘Research and development progress’ on page 31 of our Annual Report 2025.
D. TREND INFORMATION
For more information on commercial dynamics across Novo Nordisk therapy areas, we refer to ‘Commercial execution’ on pages 20-25 of our Annual Report 2025.
The key drivers behind Novo Nordisk’s performance continue to be the changes in demographics globally reflecting a continuous growth in the proportion of people who live in cities (urbanisation), an increasing proportion of elderly people and a growing prevalence of obesity. These trends have contributed to the significant increase in the number of people with obesity and diabetes worldwide. According to the International Diabetes Federation, the number of people with diabetes is projected to increase from 589 million today (2025) to more than 780 million in 2045. Additionally, there are currently more than 800 million people living with obesity. This is also expected to grow in the coming decades.
Obesity and Diabetes care is Novo Nordisk’s largest segment comprising more than 90% of sales. The growth in the number of people with obesity and diabetes and the increasing use of the GLP-1 drug category is driving Novo Nordisk’s growth within the Obesity and Diabetes care segment.
US payers continue to leverage their size and control to demand higher rebates, particularly in the insulin segment, but increasingly in the GLP-1 category, as well. As a result, average prices after rebates for the Novo Nordisk portfolio in 2025 in the United States declined. Ultimately, pricing pressure is expected to continue in the future, driven by: increasing rebates in the commercial segment, the effect of payer consolidation, increasing exposure to high rebate channels such as Medicare and Medicaid, increasing sales in direct-to-patient cash channel as well as increasing competition.
Since January 2021, Novo Nordisk Inc. (“NNI”) has made a number of changes to its policy in the US related to facilitating delivery of its discounted medicines to commercial pharmacies that contract with covered entities participating in the 340B Drug Pricing Program. Novo Nordisk’s 340B policy has been the subject of legal challenges. As a result, Novo Nordisk has only recognised revenue related to the 340B Drug Pricing Program to the extent that in Management’s assessment it is highly probable that its inclusion will not result in a significant revenue reversal in the future. Management’s assessment considers interpretations of applicable laws, and legal and administrative rulings, as well as attrition and experience from historical claims. As of 31 December 2025, provisions for 340B statutory discounts included in the 'sales deductions and product returns' amounted to USD 4.2 billion. On 30 January 2023, the US Court of Appeals for the Third Circuit issued a ruling holding that Novo Nordisk’s drug distribution policy was consistent with the 340B statute. On 21 May 2024, the US Court of Appeals for the DC Circuit issued a ruling in a different case involving the drug distribution policies of other pharmaceutical manufacturers that similarly held that their drug distribution policies were consistent with the 340B statute. However, an appeal in another case involving the drug distribution policy of another pharmaceutical manufacturer is still pending before the US Court of Appeals for the Seventh Circuit, and as such these cases may be subject to further discretionary appellate review before the US Supreme Court. Subsequent to the ruling by the US Court of Appeals for the Third Circuit, covered entities filed Administrative Dispute Resolution (“ADR”) petitions against the Company before the Health Resources and Services Administration (“HRSA”) to recover alleged overcharges related to the 340B Drug Pricing Program. On 4 December 2025, HRSA dismissed an ADR petition filed by two covered entities, the University of Washington Medical Center (“UW”) and Harborview Medical Center (“Harborview”), stating that Novo Nordisk’s 340B policy did not result in overcharges to either covered entity, citing the ruling of the US Court of Appeals for the Third Circuit. This decision, rendered by the ADR Panel even in the absence of a ruling from the Seventh Circuit, is evidence that HRSA is applying the Third Circuit ruling as the law governing overcharge claims alleged by covered entities relating to Novo Nordisk's 340B policy. Neither UW nor Harborview timely sought reconsideration of the decision, which became final and effective on 20 January 2026 after the expiration of the reconsideration deadline. As a result, Novo Nordisk has determined that, as of 20 January 2026, it is highly probable that the inclusion of revenue relating to the 340B Drug Pricing Program claims that was previously constrained will not result in a significant reversal in the future. As such, the Company will in the first quarter of 2026 recognise revenue of USD 4.2 billion comprising the entire amount of provisions for 340B statutory discounts included in 'sales deductions and product returns'. Reference is made to Note 2.1 ' Net sales and rebates' and 3.6 'Provisions and contingent liabilities' in the consolidated financial statements in our Annual Report 2025.
In August 2022 the Inflation Reduction Act of 2022 was passed into law, and included several healthcare reforms. Against this backdrop, Novo Nordisk negotiated prices with the US government for some products in both 2024 and in 2025. Reference is made to Note 2.1 'Net sales and rebates' in the consolidated financial statements in our Annual Report 2025 for information on the Company's sales and rebates.
15
Novo Nordisk Form 20-F 2025
ITEM 5 OPERATING AND FINANCIAL REVIEW AND PROSPECTS
For 2026, continued pricing pressure within Obesity and Diabetes Care is expected.
For further information on trends, reference is made to the section ‘Financial performance’ on pages 14-19 of our Annual Report 2025. Information about expectations for the financial year 2026 can be found on pages 16-18 in the subsection ‘2026 outlook’.
E. CRITICAL ACCOUNTING ESTIMATES
Reference is made to Note 1.1 ‘Material accounting policies and key accounting estimates and judgements’ in the consolidated financial statements in our Annual Report 2025.