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信达生物(1801.HK):收入增长强劲 创新管线加速推进

Cinda Biotech (1801.HK): Strong Revenue Growth Accelerates Innovation Pipeline

國泰君安 ·  Aug 31

Introduction to this report:

24H1's revenue growth is strong, multiple clinical pipelines are progressing smoothly, and operating efficiency continues to improve. A number of non-oncology pipelines are expected to be approved for listing in 2025, driving the company to achieve EBIDAT break-even and maintain an “gain” rating.

Key points of investment:

Maintain an “Overweight” rating. 2024H1 achieved revenue of 3.952 billion yuan (+46.3%). The growth momentum was strong, and revenue slightly exceeded expectations. Optimistic about the rapid release of the company's innovative products, adjusted the 2024-2026 revenue forecast to 8.073/10.514/13.175 billion yuan (originally 7.642/9.851/13.284 billion yuan), and maintain the “gain” rating.

Product revenue has grown strongly and operational efficiency has improved significantly, and it is expected that EBIDTA will break even in 2025. Thanks to the rapid release of innovative products, 2024H1 achieved product revenue of 3.811 billion yuan (+55.1%), of which Cindilizumab 2024H1 earned $0.24 billion (+45.6%), while Q1-Q2 earned $1.17 (+91.8%)/$1.23 (+19.4%), respectively. Through improved production efficiency and continuous process optimization, the 2024H1 achieved an adjusted gross profit margin of 84.1% (+1.8pct), sales expenses ratio of 4.6% (-5.9pct), management expenses ratio 5.2% (-4.9pct), significant improvement in operating efficiency, and an EBITDA loss of 0.16 billion yuan (0.333 billion yuan compared to 23H2, 0.172 billion yuan month-on-month loss), which is expected to achieve EBIDTA break-even by 2025. The cash on hand is sufficient, reaching 10.112 billion yuan, to guarantee the company's long-term development. The new 24H2 lung cancer treatment product tarretinib (ROS1) will be approved for marketing, increasing the number of marketed products to 12 (Dabert, KRAS-G12C, launched in August), and the product matrix continues to be enriched.

There are frequent reports of innovation and breakthroughs, and the harvest of major products can be expected. ① In the CVM field, Mashidu peptide weight loss and T2D indications have been submitted, and it is expected that 25H1 and 25H2 will be approved, respectively; tetuumab (IGF-1R) has submitted an NDA, which is expected to fill the gap in thyroid eye disease treatment; the gout drug IBI128 (XOI) has entered phase III, and multi-pipeline promotion is expected to continue to expand the CVM layout. ② In terms of tumors, IBI363 (PD-1/IL-2α) showed positive phase I data in multiple cancer types, showing good potential in both immunotherapy treatment and initial treatment; IBI343 (CLDN18.2ADC) excels in gastric cancer and is about to begin phase III clinical trials; the next-generation TCE dual antibody IBI389 (CLDN18.2/CD3) has excellent efficacy in gastric cancer and pancreatic cancer. Stage I has already been read.

③ Phase III of the ophthalmology product IB302 (VEGF/C) is progressing smoothly. Enrollment is expected to be completed by the end of 24, and the data will be read out before the end of 25. ④ The self-exempt product picontibimab (IL-23p19, psoriasis) has reached the end of phase III and is expected to be submitted for NDA in 24H2.

Catalyst: Maxidu peptide approved; pipeline data read out; commercial release exceeded expectations.

Risk warning: Clinical data falls short of expectations; competitive landscape worsens.

The translation is provided by third-party software.


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