\u3000\u30 Beijing Jingyeda Technology Co.Ltd(003005) 58 Betta Pharmaceuticals Co.Ltd(300558) )
Event: Betta Pharmaceuticals Co.Ltd(300558) released the annual report of 2021. During the reporting period, the company’s operating revenue was 2.246 billion yuan, a year-on-year increase of 20.08%; The net profit attributable to the parent company was 383 million yuan, a year-on-year decrease of 36.83%; The non net profit attributable to the parent company was 346 million yuan, a year-on-year increase of 3.52%; The basic earnings per share is 92.0 yuan.
Revenue is in line with expectations, and ensatinib contributes new growth momentum. The total revenue of the company is 2.246 billion yuan, and three varieties have been commercialized, including the company’s star product Kemena, which has sold more than 10 billion since its listing; The second product, bemena, was approved for listing at the end of 2020, and the third product, beantin, was approved for listing at the end of 2021;
1) Kemena (ektinib, EGFR inhibitor): in June 2021, the indications of postoperative adjuvant treatment of Kemena were approved for listing and successfully included in medical insurance at the end of the year. It is the first and only generation of EGFR-TKI for postoperative adjuvant treatment of patients with early lung cancer in the world. We expect that it will continue to boost the volume of sales after it is included in the medical insurance;
2) bemena (ensatinib, ALK inhibitor): in November 2020, it was approved for second-line ALK positive NSCLC, and the first-line treatment indication listing application was accepted by CDE in July 2021 and approved for listing in March 2022; In January 2022, the application for clinical trial of drugs with indications for postoperative adjuvant therapy of bemena was accepted by the State Food and drug administration.
3) betaine (bevacizumab): in November 2021, Betta Pharmaceuticals Co.Ltd(300558) the third product and the first macromolecular antibody were put on the market; It marks a big step forward for BeDa in the field of macromolecular anticancer drugs and further enriches the company’s product pipeline.
The R & D pipeline was steadily promoted, and the two products were submitted to NDA. The company’s new drug R & D projects continued to be promoted. In 2021, the R & D investment was 861 million yuan, accounting for 38.32% of the operating revenue. The company has developed more than 40 new drug projects and more than 10 self-developed new drugs in the clinical stage. Bpi-361175 has won the American clinical approval for the first time, and 11 candidate drugs / indications ind; Two new products of the company have submitted NDA, including 1) bifotinib (bpi-d0316 and third generation egfrtki) submitted NDA for second-line treatment of NSCLC indications in March 2021 and accepted; 2) VEGF molecular therapy was accepted in 2021 and 2022; We expect that the two new products are expected to be approved for listing in 2022, and the company will expand from a single variety of ektinib to a multi product innovative pharmaceutical enterprise with five commercially listed varieties;
Profit forecast and investment suggestions: adjusted according to the company’s business progress and equity incentive plan, we expect the company to achieve operating revenue of 2.78 billion yuan (3.131 billion yuan before adjustment), 3.876 billion yuan (4.175 billion yuan before adjustment) and 5.24 billion yuan from 2022 to 2024, with a year-on-year increase of 25%, 40% and 35% respectively; Considering the outstanding value of the company’s R & D platform and rich innovative drug pipeline, the performance growth of new drugs after listing is expected to accelerate and maintain the “buy” rating.
Risk warning: the risk of sales falling short of expectations, the risk of R & D and application progress falling short of expectations, and policy risk
