\u3000\u30 Beijing Jingyeda Technology Co.Ltd(003005) 58 Betta Pharmaceuticals Co.Ltd(300558) )
Event:
Recently, the company released its annual report for 2021. In 2021, it realized an operating revenue of 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 year-on-year decrease is mainly due to the large amount of non economic in 2021 and the equity incentive expenses in 2021. If the non economic is deducted and the impact of equity incentive is excluded, the net profit is 411 million yuan, a year-on-year increase of 23.05%.
It has three commercial varieties, providing a strong driving force for the company's revenue growth at this stage
The market space of ektinib is still considerable, and the indications of postoperative adjuvant therapy bring new growth. In 2021, the sales volume of ektinib was about 2.1 billion yuan, with a year-on-year increase of about 15.60%. In June 2021, the new indications of postoperative adjuvant therapy of ektinib were approved for listing and included in the medical insurance catalogue through negotiation in the same year. At present, only ektinib and oxitinib have been approved for listing for this indication. Compared with oxitinib, ektinib has the advantage of medical insurance reimbursement. The approval of postoperative auxiliary indications is expected to further prolong the life cycle of ektinib and promote the continuous growth of sales.
The entry of ensatinib into Medicare is expected to rapidly expand the market, and the indications for first-line treatment are approved for listing. In 2021, the sales volume of ensatinib was 150 million yuan. The company continues to carry out the strategy of academic promotion, establish academic brands through ENSA listing meeting, MENA elite Association, ALK college and other activities, create the differentiated advantages of ensatinib, and expand the market space. In December 2021, the indications for the second-line treatment of ALK positive NSCLC with ensatinib were included in the medical insurance for the first time through negotiation; In March 2022, the indications for the first-line treatment of ALK positive NSCLC with ensatinib were approved for listing, which is expected to continue to expand the applicable population.
In addition to ektinib and ensatinib, the company still has a number of products that have recently been approved for listing or are in the NDA stage, which will provide a lasting driving force for revenue growth. Including bevacizumab that has been approved for listing, CM082 and third-generation EGFR bevotinib that are in the stage of listing approval.
The R & D layout of the company is centered on the field of lung cancer and has a certain extension, with a wide range of indications
Focusing on the field of lung cancer, the company has developed a variety of lung cancer treatment schemes or potential schemes. At present, the company's products in the field of lung cancer and products under research cover the main mutation types in NSCLC, including EGFR mutation, ALK mutation, KRAS mutation, etc. For EGFR mutation, the company is arranged along the depth of disease progression. The first generation product ektinib can be used for postoperative adjuvant treatment of stage ii-iiia NSCLC with EGFR positive, and first-line / second-line treatment of locally advanced or metastatic NSCLC. If drug resistance occurs in the first generation, patients can choose the third-generation product bevotinib. At present, the research and development progress of first-line and second-line treatment of bevotinib is in phase II / III and NDA respectively. In addition, the company's fourth generation EGFR product bpi-361175 is in clinical phase I. In addition to monotherapy, the company has developed EGFR-TKI sequential therapy and multi combination therapy combined with immunotherapy. PI3K independently developed by the company for multiple mutation types α Selective inhibitor bpi-21668 and EGFR x c-met bispecific antibody mcla-129 jointly developed with merus company have entered phase I clinical stage. In addition, in January 2022, the company approved two small molecule inhibitors for clinical trials. The PD-L1 small molecule inhibitor bpi-371153 is used to treat advanced solid tumor / lymphoma, and the SHP2 small molecule inhibitor bpi-442096 can inhibit signal transduction pathways including Ras-MAPK and PD-L1 / PD-1, which is expected to be combined with drugs for the treatment of KRAS mutation.
The company has a layout on many popular targets. The projects under research in the clinical research and development stage include PD-1 monoclonal antibody balstilimab, CTLA-4 monoclonal antibody zalifrelimab, CDK4 / 6 inhibitor bpi-16350, RTKs inhibitor CM082, etc., involving indications such as cervical cancer, renal cancer and senile macular disease.
Profit forecast and investment rating
Considering the price reduction of innovative drug guotan and the possibility of centralized purchase price reduction of bevacizumab, we reduced the company's operating revenue from RMB 3.59 and 4.72 billion to RMB 2.784 and 3.864 billion from 2022 to 2023, and the net profit attributable to the parent company from RMB 630 and 840 million to RMB 459 and 684 million. We predict that the company's operating revenue in 2024 will be 5.418 billion yuan and the net profit attributable to the parent company will be 923 million yuan. Maintain the "overweight" rating.
Risk warning: the risk of covid-19 epidemic continuing, the risk of changes in medical insurance policies, the risk of product commercialization falling short of expectations, and the risk of R & D progress falling short of expectations
