华海药业(600521):原料药制剂一体化优势助力业绩高增长 研发创新亮点突出

Huahai Pharmaceutical (600521): The advantages of API integration help high performance growth, outstanding R&D innovation highlights

方正證券 ·  05/03  · Researches

Incidents: The company released its 2022 annual report and the first quarter report of 2023. It achieved revenue of 8.266 billion yuan in 2022, an increase of 24.42% over the previous year; the net profit of the mother returned to the mother was 1,168 million yuan, an increase of 139.52% over the previous year; after deducting net profit of the non-return mother was 1,153 million yuan, an increase of 1839.98% over the previous year. 2023Q1 achieved revenue of 2,059 million yuan, an increase of 16.15% over the previous year; net profit of Guimo was 173 million yuan, an increase of 25.59% over the previous year; net profit after deducting non-return mother's net profit was 189 million yuan, an increase of 44.34% over the previous year.


(1) In 2022, the API and formulation business made concerted efforts, the integration of the API business and the recovery of the gross margin of APIs led to rapid profit growth

After the US FDA ban was lifted in 2022, the market recovered rapidly, and sales of the API and intermediates business continued to grow. The company achieved revenue of 8.266 billion (yoy +24.42%), of which the API business achieved revenue of 3.288 billion (yoy +18.67%) and gross profit margin of 47.14% (yoy+4.89pp); finished drugs achieved revenue of 4.721 billion (yoy +29.49%), gross profit margin of 75.07% (yoy-0.51pp). The increase in pharmaceutical sales in 2022 led to the dilution of fixed costs in the production of pharmaceuticals and APIs. The sharp rise in the US dollar exchange rate increased the company's exchange income by 209 million. Multiple factors helped the company's comprehensive gross margin rise to 62.36% (yoy+2.36pp), and the net interest rate rose to 14.23% (yoy+7pp). The profit growth rate was far higher than the revenue growth rate.

(2) R&D investment exceeded 1.2 billion dollars, focusing on diversified product pipeline layout and technological innovation. In 2022, the company obtained 9 domestic formulation registration approvals and completed 20 new product declarations; obtained 24 US ANDA numbers and completed 10 new product declarations; obtained 16 API registration approvals and completed 29 new registration applications; in terms of biopharmaceuticals, the company submitted 4 Chinese IND applications, 1 FDA IND application, 5 new domestic and foreign clinical approvals, totaling more than 20 research projects. Eleven products have entered the clinical phase. Phase III clinical patient enrollment for the biosimilar drug project HOT-3010 head-to-head to compare efficacy and safety with the original drug has been completed; several key clinical trial stage projects, such as HB0025, as a bispecific molecule targeting PD-L1/VEGF, are currently showing positive clinical efficacy signals and manageable safety; HB0034 is a new class 1 biopharmaceutical for the treatment of generalized pustular psoriasis (GPP) with the fastest development of similar drugs in China. It has already been launched in China for use in China Phase Ib clinical trials for patients with GPP attacks; phase II clinical studies of HB0017 in patients with moderate to severe plaque psoriasis and phase I clinical studies of HB0030 treating advanced malignant solid tumors are progressing rapidly.

Profit forecast: We expect the company to achieve net profit of 1,383 billion yuan, 1,819 billion yuan, and 2,244 billion yuan in 2023-2025, up 18.4%, 31.54%, and 24.46% respectively over the previous year. The corresponding PE valuations were 21, 16, and 13, respectively, covered for the first time, and gave a “highly recommended” rating.

Risk warning: New product development registration risks, quality control risks, price fluctuations of major API products, exchange rate changes.

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