Financial Performance - Total revenue for Q3 2025 reached $1.41 billion, a year-on-year increase of 41%[6] - Global revenue for Baiyueze® (Zebutinib) in Q3 2025 was $1 billion, reflecting a 51% year-on-year growth[6] - GAAP diluted earnings per ADS for Q3 2025 were $1.09, compared to a loss of $1.15 in Q3 2024, marking a 195% improvement[7] - Adjusted diluted earnings per ADS for Q3 2025 were $2.65, up 452% from $0.48 in Q3 2024[7] - Operating profit (loss) under GAAP for Q3 2025 was $163.11 million, a 236% increase from a loss of $120.27 million in Q3 2024[7] - Adjusted operating profit (loss) for Q3 2025 was $341.18 million, a 420% increase from $65.63 million in Q3 2024[7] - Free cash flow for Q3 2025 was $354.47 million, a significant increase of 548% from $54.71 million in Q3 2024[7] - GAAP net profit for Q3 2025 was $125 million, an increase of $246 million compared to a loss in the same period last year[14] - Total revenue for the nine months ended September 30, 2025, reached $3,844,863, compared to $2,682,417 for the same period in 2024, marking an increase of about 43.2%[32] - Net profit for the three months ended September 30, 2025, was $124,841, a significant improvement from a net loss of $121,350 in the same period of 2024[32] Revenue Breakdown - Product revenue for Q3 2025 reached $1.4 billion, compared to $993 million in Q3 2024, driven primarily by increased sales of Baiyueze®[8] - Baiyueze® sales in the U.S. for Q3 2025 were $739 million, a 47% increase year-over-year, driven by strong demand across all indications[11] - Baizean® sales for Q3 2025 were $191 million, representing a 17% year-over-year increase, supported by ongoing clinical advancements[11] Expenses and Costs - R&D expenses for Q3 2025 were $523.7 million, a 6% increase from $496.2 million in Q3 2024, reflecting ongoing clinical project advancements[10] - SG&A expenses for Q3 2025 totaled $529 million, a 16% increase from $455.2 million in Q3 2024, driven by global commercialization efforts[10] - Operating expenses for the three months ended September 30, 2025, totaled $1,052,660, compared to $951,402 in the same period of 2024, indicating an increase of about 10.7%[32] - Adjusted operating expenses for the nine months ended September 30, 2025, were $2,582,806, compared to $2,310,299 in the same period of 2024, representing an increase of 11.8%[39] Guidance and Future Plans - The company has updated its financial guidance for the fiscal year 2025 based on current information available[2] - The company updated its full-year 2025 revenue guidance to between $5.1 billion and $5.3 billion, reflecting strong growth expectations for Baiyueze®[15] - The company plans to continue advancing its late-stage hematological oncology pipeline, including promising candidates like Sotokura and BGB-16673[6] - The company expects to obtain orphan drug designation for Baiyueze® for marginal zone lymphoma (MZL) in Japan by the first half of 2026[23] - The company plans to initiate a Phase 3 trial for BGB-43395 (CDK4 inhibitor) in HR-positive, HER2-negative metastatic breast cancer in the first half of 2026[23] Market Presence - Baiyueze® is currently approved in 75 markets globally, with reimbursement in 57 markets, indicating significant market penetration[17] - 47 abstracts were accepted for presentation at the American Society of Hematology (ASH) annual meeting[6] Cash Flow and Assets - Cash and cash equivalents as of September 30, 2025, were $4,110,542, an increase from $2,638,747 as of December 31, 2024[34] - Total assets as of September 30, 2025, amounted to $7,632,586, compared to $5,920,910 as of December 31, 2024, representing an increase of approximately 29.0%[34] - The company reported a net cash provided by operating activities of $402,553 for the three months ended September 30, 2025, compared to $188,369 in the same period of 2024[36] Legal and Regulatory - The company announced that Pharmacyclics will not appeal the final written decision regarding the invalidation of the U.S. patent related to Baiyueze®[28] - The company has reached an agreement with Royalty Pharma to sell rights to receive royalties on global sales of Tarlatamab outside of China, with a potential transaction value of up to $950 million[28] Earnings Call - The third quarter earnings conference call is scheduled for November 6, 2025, at 8 AM ET, with a live stream available on the company's investor page[26]
百济神州(06160) - 2025 Q3 - 季度业绩