Introduction to this report:
2024Q1 obutinib's revenue is 164 million yuan (+9%), and clinical progress for hematomas, immunization, and solid tumors is progressing smoothly. It is expected that various drugs will be submitted for NDA in 2024, optimistic about the company's future development, and maintain an “gain” rating.
Summary:
Maintain an “Overweight” rating. The company announced 2024Q1 revenue of 166 million yuan, a year-on-year decrease of 12.4%; a gross profit margin of 85.4%, an increase of 8.1 pcts over the previous year, which was an increase of production efficiency and cost reduction; net loss of 146 million yuan, with a year-on-year increase of 132 million yuan, which affected exchange gains and R&D expenses; monetary capital of about 8.2 billion yuan, sufficient cash reserves, sufficient for the company to further commercialize.
Maintain the 2024-2026 revenue forecast at $9.48/12.48/1,700 million, maintaining the “gain” rating.
Obutinib is rapidly dosed, and it is expected that NDA will be submitted within 24 years for multiple indications. 2024Q1 obutinib sold 164 million yuan, an increase of 9% over the previous year. The medical insurance price was implemented and implemented in 2023. It continued to be dosed with 3 indications, was the only drug approved in China for the treatment of r/r MZL, and was included in the 2024CSCO lymphoma guideline's Level I recommendation plan for the treatment of 2L MZL. China's 1L CLL/SLL is expected to submit an NDA in August-September 24; US r/r MCL is expected to submit an NDA in September-October '24; combined ICP-248 treatment of 1L CLL/SLL is underway, and data is expected to be read out by the end of '24. Domestic ITP phase III registered clinical trials are expected to complete patient enrollment within 2024; SLE IIb enrollment is over half, and enrollment and mid-term data analysis are expected to be completed within 2024. We expect the hematoma field to expand rapidly as the CLL/SLL treatment line of obutinib is raised and MCL is marketed in the US.
The innovative pipeline is progressing smoothly, expanding self-immunity and solid tumor treatment. 2024Q1 R&D cost is 178 million yuan (+26.1%), R&D investment continues to be invested, and R&D is progressing smoothly: ① Tafasitamab China r/r DLBCL is expected to submit the BLA in May-June '24. ② ICP332 (TYK2-J H1) has obtained PoC to treat atopic dermatitis, and phase III will soon be initiated; and phase II of Chinese vitiligo will be initiated within the year; the IND for US PK bridging has been submitted. ③ Phase II of ICP488 (TYK2-JH2) treatment for psoriasis is about to be completed. Phase II data will be read before the end of 2024. ④ The ICP-723 (NTRK) advanced solid tumor registration clinical trial is progressing at an accelerated pace, and it is expected that an NDA will be submitted by the end of 2024. ⑤ ICP-189 (SHP2) combined with the third-generation EGFR inhibitor vormetinib to treat advanced solid tumors completed the first patient enrollment and is expected to receive PoC within 2024.
Catalyst: Sales volume exceeded expectations, R&D progress exceeded expectations.
Risk warning: commercialization capabilities fall short of expectations; R&D falls short of expectations; risk of policy changes.