Incidents: 1) Recently, the company's treprilizumab was approved for listing by the FDA; 2) The company released the results of the 2023 three-quarter report: the company's revenue for the first three quarters of 23 years was 986 million yuan, down 19% from the previous year; net loss was 1,407 billion yuan, and the overall performance was in line with expectations.
Comment:
Treprilizumab has been approved in the US, and commercialization expansion is expected. The company's core product, triplizumab, achieved single-quarter revenue of 1.96/2.51/221 million yuan in the first three quarters of 23 years, respectively, and there is a clear trend in sales recovery. Furthermore, in October '23, the company's treprilizumab biological product license application was approved by the FDA for listing. The 2 indications approved this time covered the full treatment of recurrent/metastatic nasopharyngeal cancer, namely: 1) treprilizumab combined with cisplatin/gemcitabine as first-line treatment for adult patients with metastatic or recurrent locally advanced nasopharyngeal cancer; 2) treprilizumab monotherapy for adults with recurrent, unresectable, or metastatic nasopharyngeal cancer that has progressed during or after treatment with platinum. The company's partner Coherus plans to officially launch the commercialization of treprilizumab in the US in the first quarter of '24, and the company's commercialization competitiveness can be expected in the future.
Pharmaceutical sales were steady in the third quarter, and commercialization continued to be promoted. The company achieved revenue of about 986 million yuan in the first three quarters of 2023, mainly from the domestic market sales revenue of commercialized drugs. In the first three quarters, the company achieved a total of about 892 million yuan in commercial drug sales revenue, an increase of about 67.8% over the previous year. Among them, the sales revenue of treprilizumab injections was about 668 million yuan, an increase of about 29.7% over the previous year; deuterium hydrobromide remidevir tablets (trade name:
(Mindewei) Sales revenue of about 124 million yuan; adalimumab injection (trade name: Junmaikang?) Sales revenue was approximately RMB 99.4 million. Despite industry fluctuations, the company's pharmaceutical sales have achieved steady growth.
R&D investment continues to be strong, and pipelines are progressing in an orderly manner. In the first three quarters of 23 years, the company's R&D expenses reached 1,271 billion yuan, and R&D investment continued to be strong. The company is fully deploying the IO field with treprilizumab as its cornerstone drug, and is also actively deploying next-generation immunotherapy targets and new technologies, such as dual antibody platforms, ADC drug development platforms, and siRNA drug development platforms. In July '23, the marketing application of treprilizumab for first-line treatment of advanced renal cell carcinoma and first-line treatment for extensive small-cell lung cancer was accepted by the NMPA; in September '23, the phase III clinical study on first-line treatment of melanoma with triplizumab reached the main research end; the company's self-developed anti-BTLA monoclonal antibody combined with treprilizumab as a randomized, double-blind, placebo-controlled, and international multi-phase clinical study for patients who did not progress after chemotherapy for localized small cell lung cancer Obtained FDA and NMPA It was agreed to be carried out; in September 2023, the clinical trial application for anti-PD-1 and VEGF bispecific antibodies was approved by the National Drug Administration, and the administration of the first patient was completed in the same month.
Profit forecast, valuation and rating: Considering the continuous increase in the company's R&D investment, the time required for treprilizumab sales to climb, and other product sales progress, we lowered the company's net profit forecast for 23-24 to -15.7/1.38 billion yuan (previous time -59/- 4.4 billion yuan), and added the 25-year net profit forecast to -774 million yuan. The company is a first-tier domestic innovative drug enterprise. The internationalization process is accelerating, maintaining the “buy” rating of A share/H shares.
Risk warning: risk of drug development failure, risk of product sales falling short of expectations, risk of product price reduction.