Events:
On August 31, the company issued the 2022 interim results report, during the reporting period, the company achieved a total revenue of 75 million yuan, an increase of 234.7% over the same period last year, of which the product revenue was 54 million yuan, mainly due to the rapid release of PD-L1 monoclonal antibodies. The net loss was 147 million yuan, down 44.9% from the same period last year, and the loss narrowed significantly. During the reporting period, the company's R & D expenditure was 216 million yuan, which was the same as the same period last year.
Comments:
The first hypodermic injection product achieves rapid volume, and the commercial value is initially revealed. By the end of the reporting period, the company's first commercial product, PD-L1 Monoclonal Antibody (KN035), achieved a product income of 54 million yuan. As the world's first subcutaneous injection product, it had obvious competitive advantages and achieved rapid volume in the first year of commercialization. At the same time, gastric cancer, colorectal cancer, clinical application of immune checkpoint inhibitors and other CSCO guidelines were highly recommended during the reporting period. By the end of the reporting period, more than 10000 patients had been served, and user accessibility and clinical value were highlighted. At present, a new usage and dosage scheme has been added to the product, which helps to improve the convenience of patients and benefit more clinical patients.
Clinical pipeline development has entered a critical stage, and a number of core products are expected to achieve rapid breakthroughs. During the reporting period, the company made a total of 8 milestones in product development. Among them, a number of registered clinical studies of targeted PDL1/CTLA4 double antibody KN046 were carried out smoothly, and the mid-term analysis of the III phase clinical study of the first-line treatment of advanced non-small cell lung cancer successfully reached the preset PFS end point and entered the Pre-BLA phase; the first-line treatment of advanced pancreatic cancer III phase clinical study completed more than 50% of the group, is expected to bring a new breakthrough for the treatment of advanced pancreatic cancer.
A new generation of targeted HER2 double anti-KN026 monotherapy has achieved good efficacy and controllable safety results in the treatment of previously treated advanced HER2-expressing gastric cancer or gastroesophageal junction cancer in phase II clinical studies.
In addition, KN019 achieved preliminary results in phase II clinic in the field of RA autoimmune diseases, and independently developed double anti-KN052 phase I clinic to complete the administration of the first patient. The company makes full use of its own technological advantages, the pipeline layout is reasonable, and the advantage of innovation and differentiation in the future is expected to be verified.
The production capacity is further expanded to promote the sustainable development of the company. During the reporting period, the company's R & D and industrialization capacity was further improved, with a total planned production capacity of 42000L and an annual production capacity of more than 5 million units, and a new 6000L production facility will be completed by the end of 2022, which will give impetus to the sustainable development of the company.
Profit forecast: the company is in good business condition and is expected to develop healthily in 2022. From 2022 to 2024, the company is expected to achieve revenue of RMB 2.03 million and earnings per share of RMB 0.52 million per share, with an investment rating of "overweight" for the first time.
Risk hints: competition aggravates risks, performance forecasts and valuation judgments fall short of expectations