Incident Overview
The company's 2024 semi-annual report: The company's product revenue was 11.908 billion yuan, and the product revenue for the same period last year was 6.696 billion yuan. The company's net loss attributable to the owner of the parent company was RMB 2.877 billion, and the net loss attributable to the owner of the parent company after deducting non-recurring profit and loss was RMB 3.125 billion.
Analytical judgment:
The increase in product revenue was mainly due to increased sales of self-developed products Baiyueze (zebutinib capsules) and Baizeam (tirelizumab injections) and authorized Amgen products. In the first half of 2024, Baiyueze's global sales totaled 8.018 billion yuan, an increase of 122.0% over the previous year, further consolidating its leading position in the field of hematologic oncology.
Among them, US sales totaled 5.903 billion yuan, up 134.4% year on year. More than 60% of the quarter-on-quarter demand increase came from the expansion of use in chronic lymphocytic leukemia (CLL) indications, while the market share of this product in new CLL patients continued to increase. European sales totaled $1.057 billion, up 231.6% year over year, mainly due to the product's increased market share in all major markets, including Germany, Italy, Spain, France and the United Kingdom. The total sales volume in China was 0.873 billion yuan, up 30.5% year over year, mainly due to the increase in sales of this product in approved indications. The company continues to maintain its leading market share in the BTK inhibitor market in China. Currently, five of the six indications approved by China that meet the eligibility criteria have been included in the national health insurance catalogue. In the first half of 2024, Baizean's sales totaled 2.191 billion yuan, a year-on-year increase of 19.4%. The increase in Baizean's sales is mainly due to the demand for new patients brought about by the inclusion of new indications in medical insurance and the increase in the number of drugs entering hospitals. Baizean has gained a leading market share in the PD-1 sector in China. Currently, Baizean has been approved for 13 indications in China, of which 11 indications that meet the eligibility criteria have been included in the national health insurance catalogue.
Overseas markets are actively expanding, and volume can be expected
Baiyueze, a BTK inhibitor independently developed by the company, has been approved for multiple indications in more than 70 markets, including the United States, China, the European Union, the United Kingdom, Canada, Australia, South Korea and Switzerland. It has established an extensive clinical development layout around the world, and has enrolled more than 6,000 subjects in more than 30 countries and regions. The final progression-free survival (PFS) analysis results of Baiyueze's “head-to-head” versus ibutinib (ibutinib) global clinical phase III ALPINE trial for adult patients with recurrent or refractory (R/R) CLL/small lymphocytic lymphoma (SLL) were presented as a summary of the latest breakthroughs at the 2022 American Society of Hematology (ASH) Annual Meeting (ASH) and also published in the “New England Journal of Medicine”. Baiyueze and Yike continued to show PFS benefits in the treatment of adult R/RCLL/SLL patients, and the incidence of cardiovascular events continued to be low. Positive data with a median follow-up of 39 months was shown at the ASH annual meeting held in December 2023. Based on the final analysis results of the ALPINE trial PFS, the company has obtained approval from the US, the European Union and the UK to include the PFS efficacy results obtained in the Phase III ALPINE trial compared to adult R/R CLL/SLL patients (median follow-up time of 29.6 months), further consolidating Baiyueze's position as the preferred BTK inhibitor.
Investment advice
Considering the continuous approval of new global indications and the rapid release of products after approval, we adjusted the early profit forecast, that is, we forecast that the company's revenue for 2024-2026 will be 25.7/33.2/39.7 billion yuan (previous value 22.26/28.37/35.12 billion yuan), an increase of 47%/30%/19% year-on-year, and net profit to mother of -4.66/-0.33/2.87 billion yuan, respectively (previous value -4.951/-2.097/3.133 billion) Yuan), a year-on-year increase of 31%/93%/966%, EPS was -3.39/ -0.24/2.08 yuan respectively, corresponding to the closing price of 149.18 yuan/share on August 29, 2024, and PE was -44/-620/72 X, respectively. Considering that the company's performance had a lot of room for growth, it maintained a “buy” rating.
Risk warning
New drug development falls short of expectations, there is a risk that global cooperation will be interrupted, and commercialization performance after product launch falls short of expectations.