On April 26, the company released its 2022 performance report. In 2022, the company achieved main revenue of 791 million yuan (+49.22% year-on-year); net profit of 131 million yuan (+614.22% year-on-year); net profit after deducting non-return to the mother was 79 million yuan (+227.94% year-on-year); of these, the company achieved main revenue of 273 million yuan in the Q4 quarter (+546.92% year-on-year); Fumo's net profit for the single quarter was 77 million yuan (+165.67% year-on-year).
Comment:
The commercialization of the core product, volmetinib, performed excellently. After deducting net profit from non-return to the mother, it turned a loss into a profit for the first time. For the first time, the core product led the company to achieve a double positive return to the mother/deduction of non-net profit, and successfully removed U. During the reporting period, the company's original anti-tumor product, the third-generation EGFR-TKI volmetinib, was commercialized rapidly, and sales revenue for the full year of '22 was 790 million yuan (+235.29% year-on-year), achieving a significant increase.
Indications for first-line treatment of NSCLC with volmetinib were approved during the reporting period, driving release; EGFR 20 exon insertion mutation NSCLC second-line treatment indications were included in breakthrough therapy. In August, domestic phase II registered clinical trials were approved to be carried out. Clinical adjuvant treatment and combination drug use are progressing in an orderly manner. The differentiated clinical advantages of core products are obvious, and commercialization potential can be expected.
Clinical R&D costs are continuously optimized to further explore the potential for core product pipeline development. During the reporting period, the company invested 192 million yuan in R&D (-13.86% year on year), accounting for 24.24% of operating income (-17.75pct year on year). By the end of the reporting period, the core product, volmetinib, was in phase III clinical stage for phase II-IIIA adjuvant treatment of positive EGFR mutation after radical resection; phase II registered clinical research for second-line treatment of 20 exon insertion mutation was being actively promoted, and a phase Ib/II clinical trial using RC108 monoclonal antibody was approved this year. In addition, the company's independent development of new drugs targeting KRAS G12C/D, RET, SOS1, etc. is already in the clinical development stage. Gradually optimize pipeline layout, actively expand the scope of indications, and drive sustainable development through cost optimization.
Strengthen the company's commercialization capabilities to achieve comprehensive market coverage. By the end of the reporting period, first-line and second-line treatment of volmetinib had been included in the scope of medical insurance reimbursement. The company had formed a marketing team of nearly 650 people, covering 30 provinces and cities, and about 1,000 hospitals in the core market area to continuously strengthen the specialized sales and promotion of volmetinib and accelerate omnichannel deployment. In addition, during the reporting period, the company reached an agreement with Jiangsu Fosun to grant it exclusive promotion rights to more than 2,000 hospitals to carry out specialized and differentiated academic promotion of volmetinib, which is expected to achieve full market coverage of the commercial layout.
Profit forecast: The company focuses on small molecule targeted drug development, has built an advantageous R&D pipeline, and its main business revenue is growing steadily. Revenue for 2023-2025 is expected to be $14.24/22.78/$3.188 billion, and earnings per share of $0.58/1.03/1.37 yuan, covering the “increase in holdings” investment rating for the first time.
Risk warning: Industry competition intensifies, product commercialization falls short of expectations.