Introduction to this report:
The company's performance increased dramatically in 2023, turning a loss into a profit, and Cardonelli expanded rapidly. Ivosi is about to be approved domestically, and head-to-head data on pabolizumab will soon be revealed. Maintain an “Overweight” rating.
Summary:
The performance increased significantly and the “gain” rating was maintained. The company achieved revenue of 4,526 billion yuan in 2023, +440% year-on-year; achieved profit of 1.942 billion yuan, turning a loss into a profit. The company achieved product sales of $1,631 billion in 2023, and revenue from technology licensing and technical cooperation of $2,923 billion (mainly from the down payment of the Iwasi license from partner Summit). Taking into account the impact of changes in the hospital's sales environment, the 24-25 revenue forecast was adjusted to RMB 2,896/4.421 billion (the original forecast was RMB 29.98/4.933 billion yuan), and the revenue forecast for 26 years was increased to RMB 5.989 billion. Maintain an “Overweight” rating.
Cardonil has been released at high speed, and new indications have been declared for sale one after another. In 2023, Cardonelli achieved sales of 1,358 billion yuan, +149% year-on-year, showing a rapid volume trend. Currently, the NDA for first-line treatment of G/GEJ adenocarcinoma combined with chemotherapy has been accepted by the NMPA. According to the company's official website, subsequent expected milestones include: (1) 2024Q1 submitting an NDA for first-line late recurrence/bevacizumab for first-line late recurrence/metastatic cervical cancer; (2) the registered phase III clinical study of 2024Q4 cardonil monotherapy for adjuvant treatment after surgery for hepatocellular carcinoma is expected to complete patient enrollment; (3) the reading of registered phase III clinical data for first-line treatment of advanced gastric cancer and first-line treatment of advanced cervical cancer in 2024, and the possibility of initiating registered phase III clinical trials in other tumor types.
Ivosi is about to be approved domestically, and head-to-head data on pabolizumab will soon be revealed. Iwasi is developing 3 registered phase III clinical trials in China and 2 international multi-center registered phase III clinical trials globally. According to the company's official website, its expected milestones for 2024 include: (1) 2024Q2 NMPA is expected to make a decision on the NDA of Evosi, which is expected to be approved for marketing with excellent efficacy against EGFR-TKI in treating NSCLC; (2) 2024Q2 evosi versus pabolizumab first-line treatment of PD-L1+ delayed/metastatic NSCLC registration phase III clinical trials are expected to usher in mid-term analysis (main end point of PFS); (3) 2024H2 evosi+ chemotherapy versus laserizumab chemotherapy First-line late/metastatic squamous NSCLC registration phase III clinical trials are expected to complete enrollment; (4) The 2024 H2 Summit led the enrolment of patients in the international multi-center phase III clinical study of evasil+ chemotherapy for late-stage and non-squamous NSCLC that progressed through three generations of EGFR-TKI treatment.
Catalysts: Excellent clinical trial results; new products approved for marketing; commercial release exceeded expectations.
Risk factors: the risk of uncertainty in the development of new drugs; the risk that commercialization progress falls short of expectations.