\u3000\u3000 Nanjing King-Friend Biochemical Pharmaceutical Co.Ltd(603707) (603707)
Event: on February 7, 2022, the company announced that the Anda application of furosemide injection, 20mg / 2ml, 40mg / 4ml and 100mg / 10ml, declared by the company’s subsidiary Jianyou Hong Kong to the FDA, was approved.
Furosemide injection was approved by anda in the United States, and another member of the variety of exported preparations was added. Furosemide injection is mainly used to treat edema diseases, including congestive heart failure, liver cirrhosis and kidney diseases. The original research is held by americanregent Inc. it was approved by FDA to be listed in the United States on November 30, 1983. The specification is 250mg / bottle, and the NDA application number is n018579. In 2020, the U.S. market sales will be about $50 million. At present, furosemide injection of 11 companies in the United States has been approved for listing, and the main competitors include freseniuskabiusallc, hikmapharmaceuticalusainc, hospirainc, etc. The company has grown from the leader of heparin API to the head enterprise of injection internationalization. The preparation export business of 2021h1 company in the United States has maintained rapid growth, and the preparation export business accounts for more than 60% of the company’s overall preparation business. The company is one of the enterprises with the largest export scale of injection in China, and it is also the Chinese local production enterprise with the largest number of injection anda in the United States. The approval of this new variety is conducive to the company to increase the market share of overseas preparations under the condition of cost advantage and sufficient production capacity.
The preparation products were quickly approved, and the preparation business became the main growth point of performance. As of February 7, 2022, the company has more than 40 anda approvals, covering more than 30 varieties. Over the past three years, the company has rapidly accumulated a variety pool with an average annual rate of more than 10 FDA injection approvals. It is expected that the next time the company’s products are approved by anda, the variety pool will reach more than 80 by 2025, with a large growth space. Heparin preparation: in 2021h1, the global sales exceeded 40 million, an increase of about 70% over the same period of last year; Sales in China reached 13 million, an increase of more than 30% over the same period last year. Non heparin preparations: up to now, the company has nearly 30 approval documents for injection varieties. Overseas: several injection varieties have quickly occupied about 10% of the market share in the United States in a few months, and the market share of some advantageous products has reached about 30%, of which cisatracurium benzenesulfonate injection accounts for nearly 30% of the market share in the United States, Bleomycin Injection and gemcitabine injection account for about 20% of the market share in the United States; China: in 2021, the company fully launched the sales of new products in China and obtained four product registration approvals, including Bai Xiaoan injection, bendamostine hydrochloride for injection, milrinone injection and fondaparinux sodium injection, further opening up the growth space of the company’s injection business in China.
Profit forecast and investment suggestions. It is estimated that the EPS from 2021 to 2023 will be 0.88 yuan, 1.15 yuan and 1.5 yuan respectively, and the corresponding valuations will be 37 times, 28 times and 22 times respectively. Maintain a “hold” rating.
Risk tip: the price and sales volume of heparin API are lower than expected; The sales of preparation products are less than expected; Anda was approved less than expected; R & D progress is less than expected.
