已上市产品持续增长，业绩超预期。公司上半年收入增长稳健，其中益赛普销售收入3.04 亿元，同比增长24.98%；赛普汀销售收入1.09 亿元，同比增长60.46%；健尼哌收入同比增长34.27%。此外，公司CDMO 业务稳步推进，较去年同期同比增长191.69%。公司进一步降本增效，管理和研发费用分别同比降低22.76%和11.50%，随着收入增加，上半年同比扭亏。Matters:
Sansei Guojian's revenue for the first half of 2023 was 478 million yuan, an increase of 40.28% over the previous year; net profit of 94.75 million yuan, compared to 7.19 million yuan for the same period last year; net profit of 83.64 million yuan after deducting non-return net profit of RMB 83.64 million, during the same period last year - 29.06 million yuan, turning a loss into a profit.
Commentary:
Listed products continued to grow, and performance exceeded expectations. The company's revenue grew steadily in the first half of the year. Among them, Yisaipu's sales revenue was 304 million yuan, up 24.98% year on year; Septin's sales revenue was 109 million yuan, up 60.46% year on year; and Genipper's revenue increased 34.27% year on year. Furthermore, the company's CDMO business is progressing steadily, with a year-on-year increase of 191.69% over the same period last year. The company further reduced costs and increased efficiency. Management and R&D expenses decreased by 22.76% and 11.50%, respectively. As revenue increased, losses were reversed year-on-year in the first half of the year.
Tumor products are removed, and the self-elimination pipeline is advancing rapidly. The company adjusted its development strategy and focused on the self-exemption track after authorizing the removal of the tumor pipeline. Clinical progress was significantly accelerated, and a number of new developments were made:
1) Clinical phase II treatment of moderate to severe atopic dermatitis with IL-4Rα monoclonal antibody SSGJ-611 was completed in March and reached the main end point in August. Furthermore, 611 clinical phase II patients treating chronic sinusitis with nasal polyps have begun to be enrolled, and clinical phase II IND for COPD has been accepted.
2) The IL-17A monoclonal antibody SSGJ-608 was enrolled in clinical phase III patients with moderate to severe plaque psoriasis in April. The data was read out in the second half of this year. We expect to submit a marketing application in 2024, ranking in the top three among domestically produced IL-17A monoclonal antibodies. The company also completed 608 pre-IND applications for axial spondylitis treatment.
3) The IL-5 monoclonal antibody SSGJ-610 completed enrollment in phase II subjects with severe eosinophilic asthma in July of this year. Data were read out in the second half of this year, ranking first among similar domestically produced products.
4) IL-1beta monoclonal antibody SSGJ-613 acute gout arthritis clinical phase II has reached the main end point. It is planned to initiate phase III clinical communication, which is second in progress among similar domestically produced products.
5) The IL-33 monoclonal antibody SSGJ-621 has been clinically approved by the FDA for treatment of COPD, and accepted by the domestic IND. Currently, only two domestically produced IL-33 monoclonal antibodies have been declared clinically.
Self-exempt product matrices are formed, and competitive advantages are highlighted. It is expected that by 2024, the company's 3 mature products will maintain steady growth, 1 self-exempt product will apply for listing, and 3 will advance in Phase III. The target of self-exempt drugs is clear, and competition for research and development is intense, but at the same time, there are many patients, and the potential market size is large. With Yisei Guojian, an experienced self-exemption sales team has been established. The production capacity layout is sufficient, and the multi-pipeline product matrix is gradually being formed. It is expected that it will gain a competitive advantage on the fierce self-exemption track.
Investment advice: Be optimistic about the company's self-exempt sector layout. We expect the company's operating income for 2023-2025 to be 13.23 (including authorized revenue), 10.24 and 1,362 million yuan, respectively, an increase of 60.3%, -22.6%, and 32.9% year-on-year; net profit to the parent is 539 million, 1.46 million yuan, and 254 million yuan. According to the innovative pharmaceutical product pipeline valuation method (risk-adjusted cash-flow discount method) and the DCF valuation estimate for listed biological products, the company was given an overall valuation of 16.3 billion yuan, with a corresponding target price of 26.5 yuan, maintaining the “recommended” rating.
Risk warning: Clinical progress falls short of expectations, commercialization performance falls short of expectations, changes in the competitive landscape, risk of losing arbitration.
