Under the spotlight of the first class, the approval of a new drug can always stir up a thousand waves.
Recently, the National Medical Products Administration released information showing that Semaglutide tablets of Novo Nordisk (China) Pharmaceutical were officially approved, becoming the first GLP-1 (glucagon-like peptide-1) receptor agonist that can be taken orally in China for type 2 diabetes. This news has undoubtedly dropped a bombshell in the pharmaceutical world.
Semaglutide, the name has been closely associated with the "miracle drug" in recent years. Novo Nordisk's injectable version has achieved remarkable results in the field of weight loss, and is regarded as a benchmark by many people around the world who pursue a healthy body. And when the efficacy of the oral version of semaglutide in patients with type 2 diabetes has been confirmed, the prospect of this drug has been infinitely magnified.
In March 2023, Novo Nordisk proudly announced their research results showing that oral semaglutide has demonstrated significant efficacy in patients with type 2 diabetes. This discovery undoubtedly brings new hope to patients who have been suffering from diabetes for a long time. Subsequently, in October of the same year, Novo Nordisk submitted a new dose label application to Europe non-stop, showing their great confidence in the drug.
Today, oral semaglutide has been approved for marketing in Europe, Japan and other countries and regions, and its indication range has been further expanded, which can be used for patients with type 2 diabetes who have never received drugs. This series of achievements not only proves the clinical value of semaglutide, but also further strengthens Novo Nordisk's leading position in the global pharmaceutical market.
Although the new round of semaglutide oral version failed to be approved for weight loss, this did not dampen the market's enthusiasm for the drug. In fact, as early as October 2022, Tesla CEO Elon Musk's public statement has already set off a wave of craze in the secondary market. Musk confessed that with the help of regular fasting and the use of wegovy (a type of semaglutide), he managed to lose 9 kilograms in a month. This news undoubtedly adds another fire to the market prospects of semaglutide.
From the perspective of the global GLP-1 agonist market share in 2022, semaglutide dominates the group with a proportion of 39%, becoming the GLP-1 drug with the highest market share. This data not only reflects the strong competitiveness of semaglutide in the market, but also indicates its huge potential in the pharmaceutical market in the future.
In recent years, Novo Nordisk's semaglutide products have maintained a strong growth momentum. The 2023 annual report shows that the annual revenue reached a staggering 2,322DKK 6.1 billion, up 31% year-on-year; At constant exchange rates, the increase was as high as 36 percent. Operating profit also increased by 37% to 1,025DKK 7.4 billion.
Therefore, on the morning of January 31, European time, Novo Nordisk's market value once reached an astonishing $506 billion, still firmly ahead of the second place LVMH, becoming the European company with the highest market capitalization.
In the deep ocean of finance, Novo Nordisk (NVOUS) has just released its 2023 voyage report, revealing the year's brilliant results and future ambitions.
According to the financial report, Novo Nordisk's annual revenue is as high as 23226.1 billion Danish kroner, which translates to about 337 US dollars7.1 billion, an impressive 31% year-on-year increase. Operating profit also rose steadily to 10257.4 billion Danish kroner, or about 149$1.4 billion, up 37% year-on-year. The net profit has achieved leapfrog growth, reaching 8368.3 billion Danish kroner, or about $12.1 billion, an impressive 51% year-on-year increase.
From the perspective of business territory, the diabetes and obesity care business has become the growth engine of Novo NordiskTotal revenue soared to 21509.8 billion Danish kroner, or about 312$7.5 billion, a strong 38% year-over-year increase. Among them, the GLP-1 diabetes product, semaglutide, performed particularly eye-catching, with a revenue of 1231DKK 3.2 billion, or about $17.8 billion, an increase of 48% year-on-year. Obesity care products also showed explosive growth, with revenues soaring to 4163.2 billion Danish kroner, or about 60$5.3 billion, a year-on-year increase of 147%.
However, in the field of rare disease products, Novo Nordisk has suffered some setbacksThe total revenue is about 171DKK 6.3 billion, or about 24$9.6 billion, down 16% year-on-year. This may remind the market that even pharmaceutical giants need to continue to invest and innovate in different fields in order to maintain an overall competitive advantage.
In terms of geographical distribution, the Chinese market has contributed to the steady growth of Novo Nordisk. The total revenue is about 1668.7 billion Danish kroner, or about 24$2.6 billion, up 3% year-over-year. It is worth mentioning that GLP-1 semaglutide products performed particularly well in the Chinese market, with a revenue of 620.8 billion Danish kroner, or about 90.3 billion US dollars, accounting for a whopping 766% market share. This undoubtedly highlights the huge market potential in China in the field of diabetes and obesity care.
In fact, semaglutide, as a star product of Novo Nordisk, has been in the limelight in recent years. Its product line includes three blockbuster products: Ozempic for injection, Wegovy for injection and Rybelsus for tablets. Ozempic sales reached a staggering 9571.8 billion Danish kroner, or about 139$1.7 billion, an increase of 60% year-on-year; Wegovy's sales volume also achieved the highest growth, reaching 3134.3 billion Danish kroner, or about 45$5.7 billion, a staggering 407% year-on-year; And the sales of Rybelsus also rose steadily, reaching 187500 million Danish kroner, or about 27$2.6 billion, up 66% year-over-year.
Novo Nordisk is optimistic about growth in 2024. Sales are expected to increase by 18% to 26% and operating profit is expected to increase by 21% to 29%. This is based on the rapid growth of the drug market and the company's in-depth layout in this field.
In November last year, Novo Nordisk announced a major investment plan to invest more than 42 billion Danish kroner (about $6 billion) in the next few years to expand its plant in Denmark. The plant, which covers an area of about 170,000 square meters, will significantly increase the production capacity of the first drug Wegovy and other drugs.
The ambitious construction project is expected to begin at the end of 2025 and be completed in 2029. Some of this investment is already included in the DKK 25 billion capital expenditure announced in February.
The investment will comprehensively increase Novo Nordisk's global value chain capacity, from active pharmaceutical ingredient (API) manufacturing to packaging. Most of the funds will be used to increase API capacity, especially for GLP-1 (glucagon-like peptide-1) drugs. This will undoubtedly inject new vitality into Novo Nordisk's competitive position in the global pharmaceutical market.
In terms of giving back to shareholders, Novo Nordisk is also not stingy.
The Company announces that at the upcoming Annual General Meeting on March 21, 2024, the Board of Directors will propose a distribution of 6. per share for 2023Final dividend of DKK 40. In addition, the Board of Directors has decided to initiate a new share buyback program of up to DKK 20 billion. This move will undoubtedly further enhance shareholder confidence and loyalty to the company.
Although semaglutide is known as the "miracle drug" in the field of hypoglycemia, it is currently in a storm of "internal and external troubles". On the one hand, the patents of star products such as Ozempic, Rybelsus and Wegovy in the Chinese market will expire in 2026, which undoubtedly casts a shadow on the company's future earnings. On the other hand, competitors such as tirapotide from Eli Lilly have also put the market position of semaglutide in jeopardy.
In recent years, GLP-1 receptor agonists such as semaglutide have performed eye-catching in the field of hypoglycemia, and even their weight loss effects have been gradually discovered and applied. However, just when it was in the limelight, a sudden patent storm pushed it to the forefront.
In June 2021, Sino-US Huadong Pharmaceutical***, a subsidiary of Huadong Pharmaceutical, submitted an invalid application for the core patent of semaglutide to the State Intellectual Property Office. Shockingly, after a series of examinations, the State Intellectual Property Office decided that the core patent was invalid in its entirety. This news is undoubtedly a heavy blow to Novo Nordisk.
It is understood that Huadong Medicine's successful invalidation of semaglutide's patent this time is mainly due to a major loophole in Novo Nordisk's confidentiality - "undisclosed experimental result data of specific compounds". This breakthrough enabled Huadong Medicine to successfully invalidate the patent.
However, Novo Nordisk did not give up. It is reported that the company has decided to appeal to the Beijing Intellectual Property Court, vowing to defend this trump card of GLP-1RA weekly preparation. Who will die in this patent war? It's still an unknown.
It is worth noting that the competition in the semaglutide API market is also becoming increasingly fierce. According to the official website of the US FDA, 9 companies around the world have obtained the DMF integrity assessment of the API, including Nuotai Biotech, which has been listed on the A-share market. This means that more generic drug companies will enter this market in the future and compete fiercely with Novo Nordisk.
In addition, other domestic manufacturers are also actively deploying the oral GLP-1 receptor agonist market. However, due to the unresolved patent issue of semaglutide, most of these domestic products are still in the early stage of clinical application, and some are even struggling in the earlier stage of research and development. This has undoubtedly cast a shadow on the development of oral GLP-1 products in China.
Industry experts said that the patent issue of semaglutide has become the biggest barrier restricting the development of oral GLP-1 products in China. The patent issue mentioned by this person is the patent for the core compound of semaglutide, "acylated GLP-1 compound". The patent, which does not expire until March 20, 2026, is considered by the industry to be the biggest barrier to oral GLP-1 products. Novo Nordisk's 2022 financial report also shows that although the patent was declared invalid, it has been appealed to the Beijing Intellectual Property Court.
If the patent is finally maintained as invalid, then domestic generic drug companies will usher in the spring of development; On the contrary, if Novo Nordisk successfully defends the patent, then domestic products will face a more severe market environment.
In this patent turmoil, Novo Nordisk's performance has undoubtedly attracted widespread attention in the market.
Some investors and analysts believe that the company's firm attitude towards semaglutide compound patents is commendable, but it also needs to be wary of possible market risks. After all, in the highly competitive market for hypoglycemic drugs, any small mistake can lead to a total loss.
A hundred years ago, professors Banting and Best of the University of Toronto discovered insulin, a major discovery that not only revolutionized the fate of diabetic patients, but also opened a new era of medicine**. A hundred years later, the successor to insulin, GLP-1, is becoming the new favorite of the market with its unique weight-loss effect.
The huge market space and "money" situation have made global pharmaceutical companies rush into this field in an attempt to get a piece of the pie in Novo Nordisk's territory.
Since 2023, the capital market's enthusiasm for GLP-1 drugs has continued to rise. Nearly 10 pharmaceutical companies, including Wingtech Pharmaceutical, Peptide Biotechnology, Chengyi Biotechnology, and Shuodi Biotechnology, have won the favor of investors and become the focus of the market.
In this fierce battle, multinational pharmaceutical companies have made big sacrifices. In July 2023, Eli Lilly ended with 19The acquisition of biotechnology star Versanis at a sky-high price of 300 million US dollars further expanded its first-class drug product line. Not to be outdone, AstraZeneca has reached an exclusive cooperation of up to $2 billion with Chengyi Biotech to jointly develop oral GLP-1 products. Roche, which had suffered setbacks in the ** drug market, also made a strong return with an advance of 2.7 billion US dollars and acquired Carmot Therapeutics, an unlisted American ** drug developer.
At the same time, domestic pharmaceutical companies are also actively deploying the GLP-1 market. According to the Tianfeng International Research Report, as of August 2023, a total of 106 clinical trial projects for GLP-1** new drugs are underway, of which Chinese companies account for as much as 40%. International giants such as Pfizer, Novartis, and Amgen and well-known domestic companies such as Hanmi Pharmaceutical, Innovent Biologics, Huadong Pharmaceutical, Hengrui Pharmaceutical, and CSPC Pharmaceutical Group are competing to develop related products, and the competition is extremely fierce.
It is worth noting that Zhifei Biotech, the "first stock of vaccines", has also joined the melee. In November, Zhifei Biotech announced that it would wholly acquire Chenan Biotech, and the GLP-1 drug pipeline in the hands of Chenan Biotech has undoubtedly become the most valued asset of Zhifei Biotech.
In order to meet the challenge, Novo Nordisk's majority shareholder Novo Holdings announced that it will acquire Catalent, a U.S. pharmaceutical company, in an all-cash deal of $11.5 billion, which aims to expand the production capacity of Wegovy, the "best miracle drug".
According to the agreement, Novo Holdings will receive a price of 63The $50 acquisition of all of Catalent's issued shares represents a premium of $16 to the latter's most recent transaction5%。Novo Holdings will also assume Catalent's debt, bringing the total value of the acquisition to $16.5 billion.
As part of the transaction, Novo Nordisk will acquire three bottling plants belonging to Catalent from Novo Holdings, which is expected to gradually increase Novo Nordisk's bottling capacity from 2026.
But the competitive environment that Novo Nordisk encountered began to change.
On the one hand, there is a shortage of ozempic in the European market, and on the other hand, the price of insulin in the US market is reduced. On March 14, 2023, Novo Nordisk announced that it would downgrade the ** of several insulin drugs in the United States, with a reduction of up to 75%. From January 2024, the company will reduce the listing** of Novolog by 75% and the listing** of Novolin and Levimir by 65%. In addition, Novo Nordisk also plans to downgrade the ** of other brands of insulin products to match the price reduction of the corresponding brands of Novo Nordisk.
This will have a significant impact on Novo Nordisk's revenue.
According to Frost & Sullivan, the number of obese people in the world will reach 19 by 2030900 million people, the number of obese patients in China is expected to reach 3 by 2030300 million people.
In the face of such a huge market, no matter how bright the halo of the giant is, it cannot stop the crazy impact of the successor.
Now, it's up to Novo Nordisk to make the next move.
Kunpeng Project
Reference: Novo Nordisk Annual Report 2023.
The 100 billion blood sugar market is in full swing, and the GLP-1RA giant gods are fighting
Decision of the State Intellectual Property Office on the Examination of the Request for Invalidation (No. 57950).
Huadong Medicine invalidated the semaglutide patent, and Novo Nordisk has appealed to the Beijing Intellectual Property Court
One syringe for a week! Novo Nordisk semaglutide was launched, and currently 8 GLP-1 drugs are competing for the Chinese market
Author | rickzhang