Brightgene Bio-Medical Technology Co.Ltd(688166) 2021 annual report comments: rapid growth in performance and rapid promotion of foreign declaration

\u3000\u3 Guocheng Mining Co.Ltd(000688) 166 Brightgene Bio-Medical Technology Co.Ltd(688166) )

Performance summary: in 2021, the company achieved revenue of 1.05 billion yuan (+ 34%), net profit of 240 million yuan (+ 43.6%), and net profit of 220 million yuan (+ 42.7%) deducted from non parent company. The performance is in line with expectations.

The gross profit margin and net profit margin increased slightly, and the expense rate was well controlled. The gross profit margin was 56.2% (+ 1.3pp) and the net profit margin was 22.6% (+ 1pp), both of which increased slightly. The sales expense rate is 4.1% (+ 1.9pp), which is caused by the promotion of commercialization of preparation products; The rate of administrative expenses is 26.2% (- 1.8pp), the rate of R & D expenses is 16.5% (- 1.5pp), and the rate of financial expenses is 0.6% (- 0.1pp).

There are many varieties of APIs, with rapid growth, and the net dose of micafen is obvious. The company’s product sales revenue was 930 million yuan (+ 38.4%). Among them, the revenue of API products was 880 million yuan (+ 38.5%), the revenue of micafungin sodium API increased by 103.3% year-on-year, the revenue of entecavir API increased by 20.5%, the revenue of caspofungin API increased by 36.1%, the revenue of anifenin API increased by 56.7% year-on-year, and the revenue of fondaparinux sodium API increased by 243.6% year-on-year. The company’s revenue from preparation products was 49.59 million yuan (+ 37.1%). Overseas equity sharing income of 54.585 million yuan (- 17.6%); Multiple orders of technical service business completed milestone delivery, realizing 67.779 million yuan (+ 44.2%).

Research and development at home and abroad has progressed smoothly, laying the foundation for medium – and long-term performance growth. The company is developing 47 projects, including high difficulty generic drugs, new respiratory preparation platform products, salmeterol inhaler, budesonide suspension for inhalation, innovative drug projects, etc. The main research and development progress at home and abroad is as follows:

Approved for marketing: oxiracetam injection, oseltamivir phosphate capsule and API; Entecavir tablets (Indonesia), agatroban API (Japan technical review), sulgenglucuronide sodium and oseltamivir phosphate API (pre registered in Korea), two intermediates of micafungin sodium (US technical review);

Under review and approval: aribrin mesylate injection and API, pimecrolimus API, carboprost ambuterol API and atropine sulfate API;

To be reviewed: micafungin sodium for injection (Indonesia), oseltamivir phosphate API, dabavancin hydrochloride API, posaconazole crystal form I (spo-i) API, obecholic acid API, everolimus (0.2% BHT) API, spinosad API and intermediate sirolimus, intermediate medenin DM1, intermediate dabavancin hydrochloride mother nucleus (United States), sulgenglucuronide sodium API Nemergoline API (Europe), micafungin sodium API (Japan), entecavir API (Korea)

Clinical phase I: ADC project bgc0228;

Preclinical study: atropine sulfate eye drops (declared ind), GIP and GLP-1 receptor dual agonist bgm0504, small molecule drug bgc1201, and colchicine external patch.

The company’s capacity utilization rate has always remained high, and the capacity under construction is expected to promote further performance growth after it is put into operation. Kapofungin, micafungin, anifenin, entecavir, oseltamivir, everolimus and other product APIs are under construction with a capacity of 3450kg; steroidal, tumor and respiratory drug APIs are under construction with a capacity of 1600kg; the construction of Suzhou high-end preparation production workshop has been completed and all are in the certification stage. Inhalants and other chemicals are under construction, with a production capacity of 64 million tablets / year, and are under construction. Indonesia’s entecavir, oseltamivir phosphate, gefitinib, sitagliptin and other APIs are under construction, with a capacity of 3677kg, and the construction is nearly completed.

Profit forecast and investment suggestions. It is estimated that the company’s EPS from 2022 to 2024 will be 0.82/1.13/1.59 yuan respectively, and the corresponding PE will be 26 / 19 / 14 times respectively. Considering that the company is in the field of high-end generic drugs and innovative drugs with high technical barriers, it has a definite source of performance growth in the world and China, and is expected to maintain a high growth rate in recent years. Maintain a “hold” rating.

Risk tip: the risk of drug price reduction, the risk of changes in international pharmaceutical policies, and the risk of exchange rate fluctuations.

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