Maintain an “Overweight” rating. The company released its 2023 annual report, achieving revenue of 1,083 million yuan (+40.3%), net profit attributable to mother of 1,511 million yuan (loss increased by 512 million yuan year on year), and 727 million yuan in cash and equivalents. 2023Q4 achieved revenue of 313 million yuan (+54.8%) in a single quarter and net profit of 481 million yuan to mother. Considering the impact of external disturbances, the 2024-2025 revenue forecast was lowered by $1,647/2.504 billion yuan (originally $2,032/$3,035 million), and the 2026 revenue forecast was added by $3.374 billion, maintaining the “gain” rating.
Taytacip SLE has been fully approved, and many indications are progressing smoothly, and it is expected that the harvest period will be ushered in. During the reporting period, Taitacip achieved sales of more than 500 million yuan, a self-exempt sales team of over 700 people, and completed admission to more than 800 hospitals. As the company improves operational efficiency and hospital admissions resume one after another, output per capita is expected to increase further, ushering in a harvest period. Furthermore, many indications are progressing smoothly: ① Taitacipu treatment for SLE changed from conditional approval to full approval, and the medical insurance catalogue was successfully renewed, which is expected to accelerate dosage. ② The RA submitted an NDA in August 2023, and 2024H2 is expected to be approved. ③ MG completed domestic phase III enrollment at the end of 2023, and is expected to submit an NDA by the end of 2024. ④ PSS and IGA domestic phase III are expected to complete enrollment in 2024H1 and 2024Q3, respectively. ⑤ Overseas SLE Phase III Phase 1 enrollment has ended, and Phase 2 is expected to complete the first patient enrollment in 24 years. ⑥ Overseas indications such as IgA nephropathy, PSS, and MG are advancing at an accelerated pace, and the multi-indication layout in the field of self-immunity is expected to accelerate product release.
The frontline of UC/GC treatment with RC48 is progressing smoothly, and overseas clinical trials continue to advance. During the reporting period, RC48 achieved sales of more than 500 million yuan, an oncology sales team of over 600 people, completed admission to more than 650 hospitals, and medical insurance catalogs for both UC and GC indications, and is expected to accelerate deployment in 2024. ① The company focuses on promoting RC4 8+PD1 treatment of 1L UC in China, and is expected to complete enrollment in 24Q3. ② The key clinical trial of RC48 single drug treatment of 2L UC US phase II is ongoing, and RC48+PD1 treatment of 1L UC US phase III is enrolled. ③ Patients with 1L gastric cancer HER2 expression treated by RC48+PD1 are expected to complete phase II within 24 years, followed by phase III. ④ RC48+PD1 was used during the perioperative period and treatment of 2L gastric cancer. The first patients were enrolled in 2023Q4 and 2024Q1, respectively. ⑤ Patients with stage III HER2 low-expression breast cancer treated with RC48 and stage II patients treated with low HER2 expression BC and H ER2 positive BC with RC48+PD1 were enrolled. ⑤ The ESGO conference announced the results of phase II of RC48 single-agent treatment for cervical cancer ≥1L, with excellent efficacy ORR of 36.4%, DCR of 86.4%, MDO of 5.5 months, and mPFS of 4.4 months.
Catalysts: Product release exceeded expectations; clinical data on new drugs under development exceeded expectations.
Risk warning: Product development falls short of expectations, sales volume falls short of expectations, and financing falls short of expectations.