2025-11-06 11:07Financial Performance - Total revenues for Q3 2025 increased by 41% to $1.4 billion compared to Q3 2024[104] - Net income for Q3 2025 was $124.8 million, a significant improvement from a net loss of $121.4 million in Q3 2024[109] - Total product revenue for the nine months ended September 30, 2025, was $3.8 billion, up 43% from $2.7 billion in the same period of 2024[109] - Net product revenue increased by 40.4% to $1,395.0 million for the three months ended September 30, 2025, compared to $993.4 million in the prior-year period, driven primarily by increased sales of BRUKINSA in the U.S. and Europe[111] - GAAP net income improved, with basic and diluted earnings per share at $0.16 and $0.15, compared to a loss of $0.36 per share in the prior-year period[140] - Adjusted net income for the nine months ended September 30, 2025, was $692,622 thousand, while the adjusted net loss for the same period in 2024 was $71,020 thousand[141] Revenue Breakdown - Global BRUKINSA revenues rose by 51% to $1.0 billion in Q3 2025 versus Q3 2024[104] - BRUKINSA global revenue totaled $1.0 billion in the third quarter, representing a 50.8% increase year-over-year; U.S. revenue for BRUKINSA was $738.7 million, a growth of 46.6%[112] - TEVIMBRA revenue totaled $190.6 million in the third quarter, reflecting a 16.7% increase compared to the prior-year period[113] - Revenue for TEVIMBRA totaled $555.3 million, representing an 18.9% increase compared to the prior-year period[127] - Net product revenue rose 43.0% to $3,805.6 million, driven by increased sales of BRUKINSA, TEVIMBRA, and Amgen products, particularly XGEVA[126] Expenses and Costs - Operating expenses increased by 10.6% to $1.05 billion in Q3 2025, driven by higher research and development costs[109] - Research and development expenses increased by 5.5% to $523.7 million for the three months ended September 30, 2025, compared to $496.2 million in the prior-year period[115] - Selling, general and administrative expenses rose by 16.2% to $528.998 million for the three months ended September 30, 2025, from $455.223 million in the prior-year period[120] - Research and development expenses increased by $119.2 million, or 8.4%, totaling $1,530.4 million for the nine months ended September 30, 2025[130] - Selling, general and administrative expenses rose by $199.8 million, or 15.1%, to $1,526.2 million, with expenses as a percentage of product sales decreasing to 40.1%[135] Cash Flow and Debt - Free cash flow for the three months ended September 30, 2025, was $354,469 thousand, significantly up from $54,714 thousand in the same period of 2024[143] - Cash, cash equivalents, and restricted cash as of September 30, 2025, totaled $4,110,542 thousand, an increase from $2,638,747 thousand as of December 31, 2024[144] - Total debt as of September 30, 2025, was $952,867 thousand, down from $1,018,013 thousand as of December 31, 2024[144] - The company paid down $75.3 million of its debt in the nine months ended September 30, 2025[144] - Total debt obligations due in the next twelve months are $813.3 million, with long-term debt obligations at $139.6 million[158] Regulatory Approvals and Developments - The FDA granted Breakthrough Therapy Designation for sonrotoclax on October 13, 2025, for treating relapsed or refractory mantle cell lymphoma[105] - The European Commission approved TEVIMBRA for neoadjuvant and adjuvant treatment of high-risk non-small cell lung cancer on August 27, 2025[107] Other Financial Metrics - Interest income, net decreased by 71.5% to $3.0 million for the three months ended September 30, 2025, from $10.6 million in the prior-year period[121] - Other expense, net was $19.0 million for the three months ended September 30, 2025, primarily due to impairment losses and foreign exchange losses[122] - Income tax expense was $22.3 million for the three months ended September 30, 2025, compared to $23.0 million in the prior-year period[123] - Gross profit for Q3 2025 was $1.22 billion, reflecting a 46.3% increase from Q3 2024[109] - Gross margin on global product sales increased to $1,198.5 million, with a gross margin percentage of 85.9% for the three months ended September 30, 2025, up from 82.8% in the prior-year period[114] - Gross margin on product sales increased to $3,279.5 million, with a gross margin percentage of 86.2%, up from 83.7% in the prior-year period[129] Market and Collaboration - A Royalty Purchase Agreement was entered into with Royalty Pharma for $885 million, related to royalty payments from Amgen's IMDELLTRA[108] - Nearly 50 abstracts were accepted for presentation at the American Society of Hematology Annual Meeting, showcasing the late-stage hematology portfolio[104] - The company expects that its operating cash flows and existing cash will fund operating expenses and planned long-term investments for at least the next 12 months[144] - As of September 30, 2025, the remaining co-development funding commitment was $183.6 million under the Amgen collaboration[161] Foreign Exchange and Market Conditions - The RMB appreciated approximately 2.5% against the U.S. dollar in the nine months ended September 30, 2025[168] - The company recognized $4.0 million in foreign exchange gains during the nine months ended September 30, 2025, compared to $2.2 million in the prior year[169]