Event
On October 27, 2023, the company announced that it had a revenue of 127 million yuan in the first three quarters of 2023 and a non-net profit loss of 241 million yuan. The revenue in the third quarter of 2023 was 47 million yuan, and the loss of non-net profit was 774 million yuan. The performance is in line with expectations.
Comment
The third-generation EGFR Beftini contributes income from commercialization, and many R & D pipelines are promoted rapidly. (1) the company's revenue in the first three quarters was 127 million yuan, mainly for the confirmation of technology license and cooperation income.
Befotinib has completed a registered clinical trial of 1L/2L non-small cell lung cancer (NSCLC), of which 2L treatment was approved by NMPA on May 29, 2023. At the same time, befotinib extended indications for previously untreated locally advanced EGFR sensitive mutations 1L NSCLC applied for NDA in January 2023, which is expected to further contribute to performance increments in the future. (2) 2D0502 is an oral selective estrogen receptor degrader (SERD) developed by the company for the treatment of breast cancer with positive estrogen receptor (ER) and negative HER2. Patients with registered III clinical trials in patients with locally advanced or metastatic breast cancer who had previously been treated with ER positive and HER2 negative were enrolled in the study. At the same time, the clinical trials of CDK4/6 inhibitors pipericilli, urate transporter 1URAT1) inhibitors and new oral selective inhibitors of TYK2 are in line with expectations.
KRAS G12C clinical data is excellent, 550 million authorized CP Tianqing commercial cooperation. The main results are as follows: (1) Garsorasib is a selective inhibitor of KRAS G12C developed by the company, which shows good anti-tumor activity in NSCLC and colorectal cancer patients. At the European Society of Oncology, the company released data from early clinical studies of Garsorasib in patients with advanced pancreatic cancer (PCa) with KRAS G12C mutation in the form of a wallpaper. The results showed that Garsorasib monotherapy showed good tolerance and clinical activity in PCa patients with KRAS G12C mutation. The confirmed objective remission rate (ORR) was 35.7% (5pm 14), the disease control rate (DCR) was 85.7% (12pm 14), and the median progression-free survival time was 8.54 months (95% CIR 2.73 minna). (2) at the same time, the company signed a license and Cooperation Agreement with CP Tianqing for Garsorasib. Under the agreement, the company grants CP Tianqing the exclusive license to develop, register, produce and commercialize the Chinese mainland area for the duration of the agreement.
Zhengda Tianqing will pay a down payment and milestone payment of up to 550 million yuan to the company and pay royalties to the company according to annual net sales, and the company's cash flow is expected to be further improved.
Earnings forecast, valuation and rating
We maintain our profit forecast with an annual revenue of 1.32 million yuan in 2023-24-25 and a loss of 461 million yuan. Maintain a "buy" rating.
Risk hint
Medical policy risk, market competition risk, new product promotion is not as expected and other risks.