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海思科(002653):差异化创新布局进入收获期 管线丰富潜力巨大

HiCisco (002653): The differentiated innovative layout has entered the harvest period, and the pipeline is rich and has great potential

德邦證券 ·  Apr 22

Results were in line with expectations, with Q1 revenue up 20% year over year. Revenue in 2023 was $3.355 billion, 11.27% YoY.

Net profit attributable to mother was 295 million yuan, 6.51% year-on-year. Non-net profit withheld from mother was 242 million yuan, or 153.20% year-on-year.

Basic earnings per share were $0.27. It is proposed to distribute a cash dividend of $2.00 for every 10 shares to all shareholders. In Q1 2024, revenue was 752 million yuan, 20.60% YoY. Net profit to mother was 91.95559 million yuan, an increase of 219.86% year over year.

Domestic release of cyclopofol is rapid, and internationalization is progressing smoothly: in 2023, Si Shuning achieved rapid release and hospital admission. In 2023, anesthetic products reported revenue of 850 million yuan, accounting for more than 25% of total revenue. At the end of 2023, all of Sishuning's indications were included in the national health insurance catalogue. Overseas, the two US phase III clinical trials for HSK3486 anesthesia-induction (IGA) indications have all reached the main pre-set development goals. In January '24, the company launched international multi-center phase III clinical trials in the US and Europe, and research is currently progressing smoothly.

The follow-up pipeline is rich. Twelve Class 1 innovative drugs have entered the clinical stage, ushered in the harvest period:

Analgesic drug HSK21542: Post-operative analgesia was declared an NDA in October 2023;

Neuralgia treatment drug HSK16149: The NDA for “diabetic peripheral neuralgia” was completed in November 2023; “post-shingles neuralgia” was declared an NDA in September 2023; the company began internal and external marketing preparations in 2023

The ultra-long-acting hypoglycemic drug HSK7653 completed the supplementation study and submitted relevant data in December 2023, and is currently undergoing supplementary review; preparations for marketing and external marketing warm-up have been fully initiated. As of 2023, it has initially completed education with endocrinology experts at the provincial level or above, covering 100+ experts, covering more than 2 rounds of core experts to establish brand awareness

Respiratory disease treatment drug HSK31858 tablets: bronchodilation is progressing smoothly in domestic phase II clinical trials. An licensing agreement was signed with the Italian Chiesi Group in November 2023 to license HSK31858's “non-cystic fibrosis bronchodilatation” indications to Chiesi Group for a fee. After the agreement came into effect, the company received a down payment of 13 million US dollars, and is expected to receive a maximum total price of US$462 million and the highest double digit sales in the future Commission; INDs for “bronchial asthma” and “chronic obstructive pulmonary disease” were approved in early April.

HSK31679 tablets (THRbeta): IND approved for non-alcoholic steatohepatitis in June 2023, phase II in progress; Protac HSK29116 dispersion and HSK40118 tablets are undergoing phase I clinical trials; HSK39297 obtained clinical approval for “primary or secondary glomerular disease” indications in December 2023, and recently initiated domestic clinical phase I studies. IND for new indications related to hemolytic disease was also approved for clinical use in March 2024. The plan is to directly launch phase II phase II clinical research

Profit forecast: Sales performance of cyclopofol is excellent. Two innovative drugs, 7653 and 16149, are expected to be launched in 24, and commercialization is ready. At the same time, there is a large market space for analgesics 21542 and respiratory drugs 31,858 in the pipeline.

We expect the company's 24-26 revenue to be 38.76, 50.86, and 6.709 billion yuan, up 15.5%, 31.2%, and 31.9% year-on-year; net profit to mother for 24-26 will be 5.52, 8.97, and 1,379 billion yuan, up 86.9%, 62.6%, and 53.8% year-on-year. The company has many catalysts this year and continues to maintain a “buy” rating

Risk warning: risk of clinical development failure, risk of sales falling short of expectations, policy risk, etc.

The translation is provided by third-party software.


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