About Novo Nordisk A/S

Novo Nordisk A/S (Novo Nordisk) operates as a global healthcare company. The company manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. The company has a broad product portfolio across Diabetes and Obesity care and Rare disease, including a full portfolio of glucagon-like-peptide-1 (GLP-1) receptor agonists for the treatment of diabetes and obesity, modern insulins and human insulins. During 2023, there has been continued strong growth across therapy areas and geographic areas in which Novo Nordisk operates. Combined with higher than expected demand, and temporary capacity limitations at some of its manufacturing sites, there have been periodic supply constraints for certain products, including the leading product by sales, Ozempic for the treatment of type 2 diabetes 1. The company also markets two drugs - Saxenda and Wegovy - for the treatment of people with obesity. From August to October 2023, Novo Nordisk acquired 100% of the share capital of a French company. Biocorp Production S.A., and its subsidiaries (Biocorp), whose primary assets are patents and know-how related to Mallya, a Bluetooth enabled add-on device that can be used in administering doses for injection pens and provide data for doctors and patients on correct dosing. In September 2023, Novo Nordisk completed the acquisition of a Canadian company Inversago Pharma Inc. (Inversago). Segment information The company engages in the discovery, development, manufacturing and marketing of pharmaceutical products and has two business segments: Diabetes and Obesity care and Rare Disease. Diabetes and Obesity Care: Includes diabetes, obesity, cardiovascular and emerging therapy areas. Rare Disease: Includes rare blood disorders, rare endocrine disorders and hormone replacement therapy. Market Novo Nordisk’s insulin and other pharmaceutical products are marketed and distributed through subsidiaries, distributors and independent agents each responsible for specific geographic areas. The company’s financial reporting is divided into: EMEA (covering Europe, the Middle East and Africa), Region China (covering Mainland China, Hong Kong and Taiwan), Rest of World (covering all other countries except for North America) and North America (covering the United States and Canada). Several of the major international pharmaceutical companies have entered the diabetes market, specifically in the area of oral products for the treatment of type 2 diabetes. In February 2018, Novo Nordisk launched the once-weekly GLP-1 product, Ozempic, for the treatment of adults with type 2 diabetes in the United States and Canada. Since then, Ozempic has become a market leading product and the company's best performing product by sales, with global sales of DKK 95.7 billion in 2023. The global branded obesity market grew 116% by volume in 2023. Wegovy has been launched in the United States, Denmark, Norway, Germany, the U.K., Iceland, Switzerland and the United Arab Emirates. Strategy The company’s key contribution is to discover and develop innovative medicines and make them accessible to patients throughout the world. The company will strengthen its leadership in diabetes and obesity, secure a leading position within rare disease and establish ourselves in cardiovascular disease (CVD). Patent Situation of key Diabetes and Obesity Care Products Novo Nordisk has received notifications from several manufacturers that they have filed Abbreviated New Drug Applications (ANDAs) for liraglutide, the active pharmaceutical molecule in Victoza and in Saxenda, respectively, and semaglutide, the active pharmaceutical molecule in Ozempic and in Wegovy, respectively, with the FDA. Novo Nordisk has 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 are licensed to launch a generic version of Victoza as of June 22, 2024, or earlier under certain circumstances. Moreover, Novo Nordisk has entered into settlement agreements regarding the U.S. patent litigation matters for Saxenda. Novo Nordisk has also entered into a settlement agreement with Alvogen Inc. regarding the U.S. patent litigation case for Ozempic. All terms of the agreements are confidential. All agreements are subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice. In March 2023, Mylan filed IPRs challenging the validity of the two patents which claim the semaglutide compound. Mylan also filed an IPR challenging the validity of a patent which claims a method of treating Type 2 diabetes using 1 mg of semaglutide. The Patent Trial and Appeal Board did not institute proceedings on the two compound patents, but did institute proceedings on the method of treatment patent. A hearing will take place in July 2024 with a decision by October 2024. In China, the semaglutide compound patent was subject to invalidation actions and was upheld by the Beijing IP Court in November 2023. This decision has been appealed to the Supreme People's Court where the case is pending. Novo Nordisk will continue to defend its intellectual property associated with liraglutide and semaglutide, including through litigation. Patent expiry in the U.S. for the semaglutide branded products - Ozempic, Rybelsus, and Wegovy is 2032. Regulation As a pharmaceutical company, Novo Nordisk depends on government approvals related to production, development, marketing and reimbursement of its products. Important regulatory bodies include the U.S. Food and Drug Administration, the European Medicines Agency, China's National Medical Products Administration and the Japanese Ministry of Health, Labour and Welfare. Treatment guidelines from non-governmental organizations such as the European Association for the Study of Diabetes and the American Diabetes Association may also impact the company. History Novo Nordisk A/S was founded in 1923.