On January 31st, Novo Nordisk released its 2023 financial report, with a total annual revenue of approximately DKK 232.261 billion (approximately USD 33.771 billion), a year-on-year increase of 31%; The operating profit was approximately DKK 102.574 billion (approximately USD 14.914 billion), a year-on-year increase of 37%, and the net profit reached DKK 22 billion (approximately USD 3.2 billion).
Novo Nordisk said that the growth was mainly driven by GLP-1 diabetes treatment and obesity treatment. In terms of business, the revenue of diabetes and obesity care business was about DKK 215.098 billion (about USD 31.275 billion), up 38% year on year. The revenue of GLP-1 diabetes products was about DKK 12.3132 billion (about US $17.903 billion), up 48% year on year; The revenue from obesity products is approximately DKK 41.632 billion (approximately USD 6.053 billion), a year-on-year increase of 147%; The revenue from rare disease drugs is approximately DKK 17.163 billion (approximately USD 2.496 billion), a year-on-year decrease of 16%.
As a star product of Novo Nordisk, Smeglutide mainly includes Smeglutide injection Ozempic and Smeglutide tablet Rybelsus for type 2 diabetes, and Smeglutide injection Wegovy for weight management.
In 2023, the total sales of these three products were approximately 145.811 billion Danish kroner (approximately 21.201 billion US dollars), a year-on-year increase of 88.78%, accounting for 62.78% of the total revenue. Among them, Ozempic injection sales amounted to approximately 95.718 billion Danish kroner (approximately 13.917 billion US dollars), a year-on-year increase of 60%; The sales revenue of Rybelsus tablets is approximately 18.75 billion Danish kroner (approximately 2.726 billion US dollars), a year-on-year increase of 66%; The sales revenue of injection Wegovy is approximately 31.343 billion Danish kroner (approximately 4.557 billion US dollars), a year-on-year increase of 407%. Rybelsus tablet has been approved for marketing in China on January 26, 2024, for the treatment of type 2 diabetes.
In addition, Novo Nordisk also has a GLP-1 weight loss drug called Liraglutide. The sales of Victoza (lipid-lowering) and Saxenda (lipid-lowering) were 8.664 billion Danish kroner (approximately 1.257 billion US dollars) and 10.289 billion Danish kroner (approximately 1.493 billion US dollars), respectively.
Some in the industry believe that due to production capacity limitations, Smegglutide has not yet demonstrated its full potential for performance. Novo Nordisk also realized this early on. On November 10th last year, Novo Nordisk issued a statement stating that it plans to invest over 42 billion Danish kroner (approximately 6 billion US dollars) in the next few years to expand its factory in Denmark, covering an area of approximately 170000 square meters, with the aim of increasing the production capacity of the weight loss drug Wegovy and other drugs.
Novo Nordisk stated that the construction project will be completed from the end of 2025 to 2029, with some of the investment already included in the announced capital expenditure of DKK 25 billion in February. This investment will increase the production capacity of the entire global value chain from active pharmaceutical ingredient (API) manufacturing to packaging, with the majority of the investment going towards API production capacity, including GLP-1 (glucagon like peptide-1) drugs.
It is worth noting that the patent for Novo Nordisk's Smegglutide is expected to expire in 2026 under normal circumstances. However, East China Pharmaceutical once challenged the original research patent of Smeglutide, and on September 5, 2022, the China National Intellectual Property Administration decided that the core patent CN200680006674.6 of Smeglutide was invalid. Subsequently, Novo Nordisk immediately appealed this decision to the Beijing Intellectual Property Court. At present, there is no consensus on the patent issue of Smegglutide.
However, the patent for Novo Nordisk's Liraglutide has long expired, and domestic companies have already developed biosimilar drugs on the market. In July 2023, the marketing license application for Liraglutide Injection (trade name: Liraglutide) for obesity or overweight indications applied by East China Medicine was approved, winning the first domestically produced GLP-1 "weight loss needle" title.
However, East China Medicine has not yet released specific sales data for this product. In an investor survey conducted in January this year, Huadong Pharmaceutical provided a response regarding the sales of Liraglutide Injection, As of now (January 10th) The company's Liraglutide injection has achieved admission sales in over 800 large hospitals, and the number of hospitals covered is still growing rapidly. It is expected to complete admission coverage for over 1000 hospitals by the end of the first quarter of this year. In addition, the off campus market is also the main sales channel for weight loss indications, including online platforms and offline pharmacies, and the company is actively expanding its layout. The company's Liraglutide Injection has completed the coverage of 20000 terminal single drug stores and is planned to be completed around the Spring Festival
Shortly after the approval of Liraglutide Injection from East China Pharmaceutical, the first domestically developed weight loss drug was also approved for market launch. In August 2023, Renhui Biotechnology approved the marketing license application for the indication of obesity or overweight for benarutide injection (trade name: phenanthramide®). In addition, in December 2023, Tonghua Dongbao's Lilalutide injection, as the second similar drug of Lilalutide in China, was also approved for marketing, but its indications were limited to adult type 2 diabetes patients to control blood sugar, and had not yet expanded to weight loss indications.
In the research pipeline of domestic weight loss drugs, Xinda Biotech's GLP-1R/GCGR dual agonist Masalidomide has achieved the primary endpoint and all key secondary endpoints in the first phase III clinical study (GLORY-1) of overweight or obese adult subjects in China. Xinda Biotechnology stated that it plans to submit its first new drug marketing application (NDA) for the weight loss indication of Masalidomide to the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) in the near future. If successfully launched, Masidu peptide will be the first domestically produced dual target receptor agonist in China.