\u3000\u30 Beijing Jingyeda Technology Co.Ltd(003005) 58 Betta Pharmaceuticals Co.Ltd(300558) )
The performance in 2021 was in line with our expectations, and the operating revenue increased steadily: the operating revenue of the company in 2021 was 2.246 billion yuan, a year-on-year increase of 20.08%; The sales expense was 815 million yuan, a year-on-year increase of 19.11%; The R & D cost was 566 million yuan, a year-on-year increase of 55.97%; The net profit attributable to the parent company was 383 million yuan, and the net profit deducted from non attributable to the parent company was 345 million yuan, with a year-on-year increase of 3.52%. The growth rate decreased, mainly due to the increase in the proportion of R & D invested by the company’s early clinical pipelines, resulting in the decrease in the proportion of capitalized R & D investment and the increase in the proportion of expenses. The total assets of the company were 6.271 billion yuan, with a year-on-year increase of 19.92%.
The core product, ektinib, was negotiated to renew the contract and reduce the price. The postoperative auxiliary indications entered the medical insurance, which helped maintain the sales of ektinib. The listing of three generations of inhibitors is imminent, helping to undertake the next generation market: the postoperative auxiliary indications of ektinib were successfully included in the medical insurance, and the annual treatment cost was reduced from 70000 to 43000, a decrease of about 38%. Despite the price reduction, BeDa cancelled the drug gift in 2022, It is expected that the impact of the price reduction on the sales revenue of ektinib will gradually disappear with the cancellation of complimentary drugs and the large amount of postoperative auxiliary indications. The clear and proven efficacy of ektinib for patients with brain metastases, the effectiveness for patients with L858R mutation, the disease-free survival of up to 47 months for postoperative adjuvant patients, combined with the market resources and brand influence accumulated by BeDa in the field of non-small cell lung cancer, and the additional 5-year data protection period obtained by ektinib with postoperative adjuvant indications, will help ektinib maintain stable sales. The NDA of BeDa’s EGFR third-generation inhibitor bevotinib has been accepted in March 2021 and will be on the market soon, which will help BeDa undertake the patients after the first generation of drug resistance.
The second-line indications of ensatinib will enter the medical insurance to accelerate the volume, and the first-line indications in China will be listed soon: the second-line indications of ensatinib will enter the medical insurance with an annual treatment cost of 124000, helping the rapid volume of ensatinib in this year’s sales. In addition, the NDA for the first-line indications of nsatinib has been accepted in July 2021, and we expect to be listed in the middle of this year. The declaration of its first-line indications in the United States may be slightly delayed due to the improvement of dosage form, but the solid clinical data have laid the certainty of its approval. In addition, BeDa is also actively seeking overseas commercial partners to give full play to the value of ensatinib in the overseas market.
The R & D Progress of several products is smooth, driving revenue growth: BeDa’s bevacizumab biological analogue was listed in November 2021. BeDa will give full play to its advantages, fully explore its commercial value in the field of non-small cell lung cancer, and obtain a certain market share in the fierce competition through the collection of 2022h2 biological analogues. In addition, in January 2022, BeDa’s safety excellent anti angiogenesis inhibitor CM082 second-line renal cancer indication NDA was accepted, and will soon become BeDa’s fourth listed product. Potential heavyweight product EGFR / CMET double antibody mcla-129 is in dose climbing.
Profit forecast and investment rating: as the new indications of the company’s core product ektinib are included in the impact of medical insurance price reduction, as well as the increase in pipeline R & D investment and the increase in the proportion of expenses, we will reduce the net profit attributable to the parent company from 8.06/11.82 to 547796 million yuan in 20222023. We predict that the net profit attributable to the parent company in 2024 will be 1.034 billion yuan, and the current market value corresponds to 36 / 25 / 19 times of PE in 20222024, However, as new products will be launched and sold in succession this year and next year, the revenue momentum is still strong and the “buy” rating is maintained.
Risk warning: pipeline R & D progress is less than expected risk; Risk of deterioration of market competition pattern; Biological analogues are not included in the risk of centralized mining; Risk of negative impact of the epidemic on product sales and clinical promotion
