Novo Nordisk (NVO) Risk Analysis

Pursuant to Section 13(r) of the Securities Exchange Act of 1934 "("Section 13("r)"), Novo Nordisk is obliged to disclose if, during 2025, it or any of its affiliates engaged in certain Iran-related activities or transactions with persons designated under Executive Order 13224 or Executive Order 13382, or dealt with the Government of Iran ("GOI"). Novo Nordisk conducts limited business relating to pharmaceutical products and devices pertaining to chronic and rare disease care in Iran, which is permitted under the US sanctions against Iran. Set forth below is a description of the activities and transactions by Novo Nordisk's subsidiaries that are required to be disclosed pursuant to Section 13(r). Novo Nordisk's US subsidiaries and US person employees are not involved in any of Novo Nordisk's activities in Iran. However, the United States maintains broad exceptions that permit the commercial sale and export of medicine and medical devices to Iran or the Government of Iran. Similar exceptions, like those encompassed in section 11 of Executive Order 13902, are also in place for the manufacturing of medicine and medical devices for use in Iran. Novo Nordisk Pars ("NN Pars"), a wholly-owned subsidiary of Novo Nordisk A/S located in Iran, contracts with a number of companies that may be owned or controlled by the GOI to distribute its products. NN Pars also sponsors educational programmes and congresses organised by GOI-controlled medical universities, and hosts and/or engages as scientific delegates or lecturers/speakers health care professionals employed by these medical universities at similar programmes in Iran and other locations. Additionally, NN Pars makes donations to GOI-controlled public health organisations focusing on diabetes awareness and policy. NN Pars receives payments from, and makes payments to, Iranian banks (some of which may be GOI-owned or controlled) relating to the sales of pharmaceutical products and devices. NN Pars makes payments incidental to its ordinary business activities to Iranian government entities and entities that are or may be GOI-owned or controlled, such as taxes, customs fees, insurance, product registration fees and telecommunications services expenses. In 2016, NN Pars purchased land from a GOI-owned or controlled holding company in order to construct a manufacturing facility in Iran. The facility opened and officially started production in August 2020 and is being used for assembly and packaging of medical pens for use in Iran. NN Pars purchases utility services from a GOI-owned or controlled entity. Novo Nordisk's gross revenue related to transactions with GOI-owned or controlled entities in 2025 was not in excess of 1% of Group sales. Novo Nordisk does not allocate its net profit on a country-by-country or activity-by-activity basis, other than as set forth in Novo Nordisk's consolidated financial statements prepared in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board (IASB); however, Novo Nordisk estimates that its net profit attributable to the transactions with the GOI discussed above would not exceed a de minimis percentage of the Group's total net profit in 2025. The purpose of Novo Nordisk's Iran-related activities is to provide access to important and essential pharmaceutical products to patients suffering from chronic diseases and haemophilia, and to improve the healthcare of the Iranian people in accordance with Novo Nordisk's access to care strategy. For that purpose, and because Novo Nordisk has determined that its activities comply with all applicable laws, Novo Nordisk intends to continue these activities (including local production of these products in Iran).

Today, biosimilar and/or interchangeable versions of insulin can be approved in the United States via the 351(k) pathway. In the EU, a biosimilar pathway and guidelines are available for insulins, and the guideline for biosimilar products issued in Japan is also relevant for insulin. A biosimilar to NovoRapid/NovoLog produced by a competitor was launched in 2020. An interchangeable biosimilar for NovoRapid/NovoLog produced by a competitor was approved in July 2021. Furthermore, biosimilar insulins are being developed in China by local competitors. The total sales of Victoza were DKK 3,020 million in 2025 (DKK 5,482 million in 2024). The compound patent for Victoza has expired. In Japan, the drug compound patent expired in 2022; in the US and Germany, the drug compound patent expired in 2023. The drug compound patent expired in China in 2017 and in 2023 a biosimilar version of Victoza was approved in China. Novo Nordisk has received notifications from several manufacturers that they have filed Abbreviated New Drug Applications (ANDAs) for generic versions of Victoza, Saxenda, Ozempic, Wegovy, and Rybelsus, respectively. The ANDAs contain Paragraph IV certifications to obtain approval to engage in the commercial manufacture, use or sale of such products before the expiration of some or all of the patents currently listed for those products in the Orange Book. Novo Nordisk filed complaints for patent infringement against these manufacturers. Novo Nordisk has entered into settlement agreements with several manufacturers that have filed ANDAs for Victoza. Consequently, these manufacturers were licensed to launch a generic version of Victoza as of June 22, 2024. Teva launched an authorised generic version of Victoza in June 2024, and Hikma Pharmaceuticals PLC launched its generic liraglutide product in December 2024. Moreover, Novo Nordisk has entered into settlement agreements regarding the US patent litigation matters for Saxenda. Novo Nordisk has now also entered into settlement agreements with Alvogen Inc. (Alvogen), Rio Biopharmaceuticals Inc. (Rio), Sun Pharmaceutical Industries Limited (Sun), Dr. Reddy's Laboratories, Ltd. (DRL), Mylan Pharmaceuticals Inc. (Mylan), Zydus Pharmaceuticals Inc. (Zydus) and Apotex Inc. (Apotex) regarding the US patent litigation for Ozempic. All terms of the agreements are confidential. All agreements are subject to review by the US Federal Trade Commission and the US Department of Justice. In March 2023, Mylan filed an IPR challenging the validity of a patent which claims a method of treating type 2 diabetes using 1 mg of semaglutide, and the Patent Trial and Appeal Board instituted an IPR proceeding. After the institution decision, Sun, DRL, and Apotex moved to join the IPR and those motions were granted. In October 2024, Novo Nordisk settled with Mylan, Sun, DRL, and Apotex prior to the IPR hearing. All terms of the agreements are confidential. All agreements are subject to review by the US Federal Trade Commission and the US Department of Justice. In China, Novo Nordisk´s semaglutide compound patent was subject to invalidation actions and was upheld by the Beijing IP Court in November 2023. This decision was appealed to the Supreme People's Court where the patent was upheld in December 2025, thereby recognising the validity of Novo Nordisk´s semaglutide compound patent. Novo Nordisk will continue to defend its intellectual property associated with liraglutide and semaglutide, including through litigation. The total sales of obesity care products (Saxenda and Wegovy) were DKK 82,347 million in 2025 (DKK 65,146 million in 2024), of which the majority of the sales comes from Wegovy. The drug compound patent for Saxenda (liraglutide) has expired in all countries. Compound patent expiry in the US for the semaglutide branded products - Ozempic, Rybelsus, and Wegovy - is 2032. For additional information, reference is made to the section 'Patent status for products with marketing authorisation' on page 25 of our Annual Report 2025.

The Company has its headquarters in Bagsværd, Denmark. The supply capacity has gradually increased, including the capacity for meeting growing demand in the future. Our main products are; Awiqli, Fiasp, Levemir, Norditropin NovoLog/ NovoRapid, NovoLog Mix/ NovoMix, NovoSeven, Ozempic, Rybelsus, Ryzodeg, Saxenda, Tresiba, Victoza, Wegovy and Xultophy. Reference is made to the sections ‘Capital expenditures in 2025, 2024 and 2023' under Item 4 for more information about the current expansion programmes. For the nature of the Company's property, plant and equipment, as of 31 December 2025 and 2024, reference is made to Note 3.3 ‘Property, plant and equipment' in the consolidated financial statements in our Annual Report 2025. The major production facilities owned by the Company are located at a number of sites in Denmark, and internationally in the United States, France, China and Brazil. There are no material encumbrances on the properties; however, the facilities in Tianjin, China are constructed on land where the remaining term of the leases is 28 and 32 years. Active pharmaceutical ingredient (API) production is located in Denmark, primarily in Kalundborg and with secondary locations in Hillerød and Gentofte, both in Denmark, as well as in New Hampshire and North Carolina, United States, respectively. The following table sets forth certain information regarding our major production sites. MAJOR PRODUCTION FACILITIESSize of production area(square metres)Major Production ActivitiesKalundborg, Denmark168,300Active pharmaceutical ingredients for obesity and diabetes as well as products for Diabetes careActive pharmaceutical ingredients for haemophiliaProducts for Rare diseaseHillerød, Denmark156,900Durable devices and components for disposable devicesProducts for obesity and diabetesActive pharmaceutical ingredients for haemophiliaBagsværd, Denmark111,200Products for obesity and diabetesClayton, North Carolina, United States89,000Active pharmaceutical ingredients for obesity and diabetes (purification)Products for obesity and diabetesGentofte, Denmark62,900Active pharmaceutical ingredients for glucagon and growth hormone therapyProducts for growth hormone therapy, glucagon and haemophilia Tianjin, China67,200Products for diabetesProduction of durable devicesMåløv, Denmark60,900Products for hormone replacement therapyProducts for oral antidiabetic treatmentProducts for oral diabetes treatmentChartres, France60,200Products for diabetesMontes Claros, Brazil56,200Products for diabetesGel production for active pharmaceutical ingredientsBloomington, Indiana, United States28,200Products for obesity and diabetesContract manufacturing organisation (CMO) related activitiesAnagni, Italy22,400Products for obesity and diabetesCMO related activitiesBrussels, Belgium18,000Products for obesity and diabetesCMO related activities In December 2021, the Company announced the investment in construction of a new purification facility and a new recovery facility as well as rebuilding of one existing fermentation facility at the production site in Kalundborg, Denmark. The investment will establish additional capacity for manufacturing active pharmaceutical ingredients. The facilities are expected to increase the production area with approximately 59,900 square metres. The facilities are expected to be operational during 2027 and the expected amount of expenditures is DKK 22.3 billion with realised spend of DKK 20.3 billion as of 31 December 2025. The facilities will be financed by cash flow from operating activities. In June 2022, the Company announced its investment in an expansion of an existing facility at the production site in Hjørring, Denmark. The investment will increase the capacity for production of NovoFine Plus needles and is expected to increase the production area by 5,900 square metres. The expansion is expected to be finalised during 2026. The expected amount of expenditures is approximately DKK 550 million with realised spend of DKK 525 million as of 31 December 2025. The expansion will be financed by cash flow from operating activities. In November 2022, the Company announced its investment in the expansion of its clinical manufacturing facilities in Bagsværd, Denmark. The investment will establish additional capacity in R&D for the manufacturing of active pharmaceutical ingredients to supply the Company's global clinical trials. The expansion is expected to increase the production area with 7,000 square metres and it is expected to be finalised in 2026. The expected amount of expenditures is DKK 9.2 billion with realised spend of DKK 8.2 billion as of 31 December 2025. The expansion will be financed by cash flow from operating activities. In June 2023, the Company announced its investment in expanding an existing API production facility in Hillerød, Denmark. The facility is expected to be operational during 2028 and its production area expected to be increased by 65,000 square metres. The expected amount of expenditures for this facility is approximately DKK 15.9 billion with realised spend of DKK 10.7 billion as of 31 December 2025. The facility will be financed by cash flow from operating activities. In November 2023, the Company announced its investment in the expansion of its API production facility in Kalundborg, Denmark. The facility is expected to be fully operational during 2029 and its production area expected to be 170,000 square metres. The expected amount of expenditures for this facility is approximately DKK 49.6 billion with realised spend of DKK 23.1 billion as of 31 December 2025. The facility will be financed by cash flow from operating activities. In November 2023, the Company announced the investment in an expansion of an existing facility at the production site in Chartres, France. The investment will significantly increase the capacity of the manufacturing site, adding aseptic production and finished production processes and an extension of the current Quality Control Laboratory. The facility is expected to be gradually finalised from 2026 to 2028 and its production area expected to be 51,100 square metres. The expected amount of expenditures for this facility is approximately DKK 16.9 billion with realised spend of DKK 6.8 billion as of 31 December 2025. The facility will be financed by cash flow from operating activities. In March 2024, the Company announced the investment in an expansion of an existing facility at the production site in Tianjin, China. The investment will significantly increase the capacity of the manufacturing site, adding aseptic production. The facility is expected to be fully operational during 2028 and its production area expected to be 25,000 square metres. The expected amount of expenditures for this facility is approximately DKK 4.1 billion with realised spend of DKK 2.1 billion as of 31 December 2025. The facility will be financed by cash flow from operating activities.