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Highlights
Recently, Haisco announced its 2023 annual report, with an operating income of 3.355 billion yuan (+11.27%), a net profit attributable to the parent company of 295 million yuan (+6.51%), and a non-net profit of 242 million yuan (+153.20%). Among them, the revenue of anesthetic products was 850 million yuan, a year-on-year increase of 94.35%, and the sales volume of cyclopofol injection increased significantly. With "innovation" as the core, the company's R&D expenses in 2023 will be 517 million yuan, a year-on-year increase of 15.36%, and innovative R&D will be steadily promoted, with 16 Class 1 new drugs under development and 4 new drugs on the market.
Non-net profit increased by 153%, and revenue from anesthetic products increased by 94%
On April 19, Haisco released its 2023 annual report, in which the company achieved operating income of 3.355 billion yuan, a year-on-year increase of 11.27%, net profit attributable to the parent company of 295 million yuan, a year-on-year increase of 6.51%, and non-net profit of 242 million yuan, a year-on-year increase of 153.20%. The company plans to distribute 2 yuan (tax included) to all shareholders for every 10 shares, with a total cash dividend of 223 million yuan (tax included).
At the same time, Haisco disclosed that in the first quarter of 2024, the company achieved operating income of 752 million yuan in the first quarter, a year-on-year increase of 20.60%, and a net profit of 91.9559 million yuan, a year-on-year increase of 219.86%.
Founded in 2000, Hisco has a product layout covering many subdivisions such as anesthesia products, parenteral nutrition, tumor antiemetic, hepatobiliary digestion, antibiotics, cardiovascular and cerebrovascular products.
Composition of operating income
In terms of products, in 2023, the revenue of Haisco's anesthesia products will be 850 million yuan, a year-on-year increase of 94.35%, accounting for 25.32% of the operating income, the revenue of parenteral nutrition will be 615 million yuan, a year-on-year decrease of 4.09%, accounting for 18.34% of the operating income, and the revenue of APIs will be 570 million yuan, a year-on-year increase of 11.34%, accounting for 16.98% of the operating income. The company said that the increase in revenue from anesthesia products was mainly due to the large increase in sales of cyclopofol injection.
Cyclopofol Injection (Sishuning) is the first Class 1.1 innovative intravenous anesthetic independently developed by Haisco, and the first Class 1 intravenous anesthetic with independent intellectual property rights in China. The product was approved for marketing in China in December 2020, entered the National Medical Insurance Catalogue through negotiation in November 2021, and added 2 new indications to the National Medical Insurance Catalogue by the end of 2023. At the same time, the internationalization process of the product continues to advance, and two phase III clinical trials in the United States have been completed, and NDA will be applied in the United States.
After entering the medical insurance, cyclopofol injection has achieved rapid volume and hospital access, covering more than 2,000 hospitals, becoming the company's largest product. According to data from Minenet, the terminal sales of cyclopofol injection in public hospitals in key provinces and cities have risen rapidly, with growth rates of 526.17% and 165.81% in 2022 and 2023, respectively.
Sales of terminal cyclopofol injection in public hospitals in key provinces and cities (unit: 10,000 yuan)
Source: The competition pattern of drug terminals in public hospitals in key provinces and cities of Minenet
R&D investment is 875 million yuan, 4 NDAs and 9 INDs are coming
With "innovation" as the core, the company will invest 875 million yuan in R&D in 2023, accounting for 26.09% of operating income. In recent years, the company's R&D expenses have continued to grow, and the R&D expenses in 2023 will be 517 million yuan, a year-on-year increase of 15.36%.
HiSilicon's R&D expenses (unit: 100 million yuan)
With continuous R&D investment, Hisco's innovative R&D has been steadily advancing and ushering in significant progress.
In the past 2023, Hisco has submitted NDA applications for 3 Category 1 new drugs HSK7653 tablets (for the treatment of type 2 diabetes), HSK16149 capsules (for the treatment of postherpetic neuralgia), and HSK21542 injections (for the treatment of postoperative analgesia after abdominal surgery). In addition, the class 5.1 new drug riluzole oral film (for the treatment of amyotrophic lateral sclerosis) has also submitted an application for registration.
2023 Hisco innovative drug registration and application
In terms of IND applications, in 2023, Hisco will submit IND applications for the first time for 8 Category 1 new drugs, HSK40118 tablets, HSK38008 dry suspensions, HSK37251 tablets, HSK34890 tablets, HSK21542 tablets, HSK36357 capsules, HSK39297 tablets, and HSK39775 tablets, all of which have been granted implicit approval for clinical trials.
In terms of generic drugs, in 2023, 2 varieties of Riprobicaine Cream and Gliclaclazide Sustained-Release Tablets will be approved for production and will be deemed to have been evaluated, and 5 varieties of Lupatadine Fumarate Tablets, Fondaparinux Sodium Injection, Compound Amino Acid Injection (18AA-VII.), Caspofungin Acetate for Injection, and Compound Amino Acid Injection (18AA-IX) will pass the consistency evaluation of generic drugs. Up to now, the company has passed/deemed to have passed the consistency evaluation of 29 varieties, of which 15 are the first to pass the evaluation.
Entering 2024, Hisco has accelerated the pace of innovation and R&D: HSK42360 tablets of Category 1 new drugs (for the treatment of advanced solid tumors) submitted IND applications for the first time, and 3 Category 1 new drugs HSK39297 tablets, HSK16149 capsules, and HSK31858 tablets have been applied for IND and obtained implicit approval for clinical trials.
16 Class 1 new drugs are under development!3 are expected to be marketed
Through continuous innovation, Hisco has 16 Class 1 new drugs in the clinical application and above research stage, all of which are small molecule chemical innovative drugs, focusing on oncology, respiratory, metabolic and perioperative drug and other disease fields, and laying out disease targets such as KOR, DPP-4, THR-β, BTK, EGFR, DDP1, etc., forming a rich pipeline project reserve.
Hisco is mainly developing Class 1 new drugs
Among the 16 Category 1 new drugs, 3 Category 1 new drugs HSK7653 tablets, HSK16149 capsules, and HSK21542 injections have been declared NDA and are expected to be marketed, and 4 Category 1 new drugs, HSK31858 tablets, HSK31679 tablets, HSK36273 tablets for injection, and HSK21542 tablets are in the phase II clinical research stage.
It is worth mentioning that HSK7653 tablets and HSK16149 capsules are expected to be approved for marketing in 2024, further enriching the company's product pipeline.
HSK7653 tablets are the world's first biweekly oral ultra-long-acting dipeptidyl peptide kinase (DPP-4) inhibitors for improving glycemic control in adults with type 2 diabetes. According to the company's annual report, the product has completed the supplementary research and submitted relevant materials in December 2023, and is in the process of issuing and reviewing the supplement. According to data from Minenet, in 2022, the sales of DPP-4 inhibitors in China's three major terminal and six major markets (see the statistical scope at the end of this article for details) will exceed 4.7 billion yuan.
HSK16149 capsule is a third-generation central nervous system calcium channel modulator, which belongs to the me-better drug of pregabalin. For this product, Hisco has laid out 5 indications, and is expected to become the first new drug in China to be approved for the indication of diabetic peripheral neuralgia, the NDA for the indication of postherpetic neuralgia is under review, the indication for adjuvant analgesia is in the phase II clinical research stage, and the indications for central neuralgia and fibromyalgia have been approved for clinical use.
Source: Minenet database, company announcements
Note: The statistical scope of "China's Three Terminals and Six Major Markets" is as follows: urban public hospitals and county-level public hospitals, urban community centers and township health centers, urban physical pharmacies and online pharmacies, excluding private hospitals, private clinics, village clinics, and county and rural pharmacies; Based on the procurement data of chemical drugs in 20 key cities such as Guangzhou, the database of sample hospitals in sample cities for continuous monitoring of all categories of chemical drugs is carried out, and the above sales are calculated based on the average retail price of products at the terminal.