2024Q3 核心品种泽布替尼美国区环比有增长，欧洲区保持环比快速增长2024 Q1-Q3 泽布替尼全球销售收入18.16 亿美元，同比增长107%；2024Q3收入6.9 亿美元，同比增长93%，环比增长8%。2024Q3，分地区来看，美国地区继续维持高增长速度，收入5.04 亿美元，同比增长87%，环比增长5%，主要受益于其在CLL 的新患者起始治疗中继续获得更多市场份额；欧洲地区收入0.97 亿美元，同比增长217%，环比增长20%，主要得益于其在欧洲所有主要市场的市场份额增加。Incidents:
Recently, the company released the main financial data for the third quarter of 2024: total revenue for the first three quarters of 2024 was 2.682 billion US dollars, up 47% year on year, net loss was 0.493 billion US dollars, a year-on-year loss of 4%; total revenue for the third quarter of 2024 was 1.002 billion US dollars, up 28% year on year, and net loss was 0.121 billion US dollars, mainly due to a decrease in non-operating income. Adjusted operating profit for the third quarter of 2024 reached $65.6 million, achieving two consecutive quarters of non-GAAP operating profit.
The sales management expense ratio decreased quarterly. For two consecutive quarters, NON-GAAP operating profit and profit of 2024 Q3 R&D expenses were 0.496 billion US dollars, and the R&D expense ratio was 50%, a year-on-year decrease of 8 pcts, and a slight increase of 1 pct over the previous year. 2024 Q3 sales and management expenses were $0.455 billion, and the corresponding expense ratio was 45%, a year-on-year decrease of 1 pct and a month-on-month decrease of 3 pcts. The company reduced costs and increased efficiency, and its operating efficiency was further improved. The adjusted 2024 Q3 R&D expenses were 0.406 billion US dollars, and the R&D expenditure rate was 40%, a year-on-year decrease of 10 pct, and a month-on-month decrease of 1 pct; the adjusted 2024 Q3 sales and management expenses were 0.381 billion US dollars, and the corresponding cost ratio was 38%, a decrease of 1 pct year-on-year and month-on-month. Compared with the GAAP index, the 2024Q3 adjusted index reduced equity incentive costs of 47.67 million and 66.93 million US dollars of equity incentive costs and depreciation expenses of 42.96 million and 7.48 million US dollars from R&D expenses and sales and management expenses, respectively. In addition, 0.078 million intangible asset amortization expenses were also deducted from sales and management expenses.
Zebutinib, the core product of 2024Q3, showed month-on-month growth. In Europe, the 2024 Q1-Q3 zebutinib global sales revenue was 1.816 billion US dollars, up 107% year on year; 2024Q3 revenue was 0.69 billion US dollars, up 93% year on year and 8% month on month. 2024Q3, by region, continued to maintain a high growth rate, with revenue of 0.504 billion US dollars, up 87% year on year, up 5% month on month, mainly benefiting from continuing to gain more market share in starting treatment for new CLL patients; European revenue of 0.097 billion US dollars, up 217% year on year, up 20% month on month, mainly due to the increase in its market share in all major European markets.
Market sales of tirelizumab continued to grow, continuing to expand the global footprint 2024 The total revenue of Q1-Q3 tiralizumab was 0.466 billion US dollars, up 13% year on year; in 2024Q3 it was 0.163 billion US dollars, up 13% year on year and 3% month on month. The HCC, GC/GEJ, and ES-SCLC indications approved before June 30, 2024 all participated in the 2024 health insurance catalogue negotiations. Furthermore, in October 2024, tiralizumab was newly approved as a new adjuvant treatment in combination with platinum-containing chemotherapy in China, and continued with this monotherapy for NSCLC after surgery. It has also been newly approved in Brazil, Singapore, Thailand, and Israel for multiple tumor indications such as NSCLC and ESCC.
Sonrotoclax and BGB-16673 have excellent clinical trial data in hematologic tumors BGB-16673. Data on the third-line phase I clinical trial CADance-101 for R/R CLL/SLL (and must have received cBTKI) will be presented at the 2024 ASH annual meeting. The summary shows that the overall ORR is 78%. The recovery rate for CR/CR with incomplete hematology was 4%, and mTTR was 2.8 months. In the 200 mg dose group, the ORR was 94% (15/16), including two CRs.
In addition, trial data for phase I clinical BGB-11417-101 for first-line CLL treatment with Sonrotoclax and zebutinib will also be announced at the 2024 ASH conference. The summary shows that the treatment has high MRD clearance and good tolerability. The overall ORR is 100%, CR is 41% and 42% in the Sonrotoclax 160 mg group and 320 mg group, respectively, and the MTTR for both groups is 2.6 months.
Profit Forecasts and Investment Ratings
Considering that the company's revenue growth exceeded expectations, we raised 2024-2026 revenue from 25.699, 32.587, 39.287 billion yuan to 265.03, 338.04, and 41.111 billion yuan; and raised 2025-2026 net profit to mother from -0.303 billion yuan and 1.197 billion yuan to -0.054 and 1.403 billion yuan. The net profit due to mother in 2024 was reduced from -3.217 billion yuan to -4.001 billion yuan in consideration of multiple ongoing research projects advancing to the critical stage of clinical development. Maintain a “buy” rating.
Risk warning: risk of policy changes, risk of global market risk, risk of R&D progress falling short of expectations
