BeiGene(BGNE) - 2024 Q3 - Quarterly Report

Revenue Growth and Performance - Total revenue for Q3 2024 increased to $1,001.6 million, up 28.2$781.3 million in Q3 2023, driven by higher sales of BRUKINSA, tislelizumab, and in-licensed products from Amgen[119][120] - Product revenue for Q3 2024 reached $993.4 million, a 66.9$595.3 million in Q3 2023[119] - Total revenue increased by 28.2% to $1,001.6 million in Q3 2024 compared to$781.3 million in Q3 2023, driven by a 66.9% increase in product revenue to $993.4 million[121][122] - Total revenue for the nine months ended September 30, 2024 increased 47.0$2,682.4 million compared to the same period in 2023[138] - Total revenue increased by 47.0% to $2,682.4 million for the nine months ended September 30, 2024, compared to$1,824.4 million in the prior-year period[139] BRUKINSA Performance - BRUKINSA global revenue for Q3 2024 was $690 million, solidifying its leadership in chronic lymphocytic leukemia (CLL) treatment[113] - BRUKINSA global revenue grew 93.0$690.3 million in Q3 2024, with U.S. revenue up 86.5% to $503.7 million and Europe revenue surging 217.2$97.3 million[123] - BRUKINSA global revenue increased by 107.0% to $1,816.2 million, with U.S. revenue growing by 111.0$1,334.6 million and Europe revenue growing by 221.0% to $245.5 million[141] Tislelizumab Performance - Tislelizumab revenue in China increased 12.8$162.9 million in Q3 2024, with additional indications eligible for 2025 NRDL inclusion[124] - Tislelizumab revenue in China increased by 14.1% to $466.4 million, driven by broader reimbursement and expanded salesforce[142] Amgen Products Performance - Amgen products revenue in China more than doubled, increasing 101.5$101.6 million in Q3 2024, primarily due to XGEVA sales growth[125] - XGEVA revenue grew 159.4% to $63.4 million in Q3 2024, contributing to the strong performance of Amgen products in China[122] - Amgen products revenue in China increased to$263.6 million, primarily due to increased XGEVA demand following NRDL inclusion[143] Collaboration Revenue - Collaboration revenue for Q3 2024 decreased by 95.6% to $8.2 million from$186.0 million in Q3 2023 due to the termination of Novartis collaborations[119][120] - Collaboration revenue decreased 95.6% to $8.2 million in Q3 2024, primarily from Novartis marketing agreement, compared to$186.0 million in Q3 2023[126] - Collaboration revenue decreased by 92.1% to $20.9 million, primarily related to the Novartis broad markets marketing agreement[144] Gross Margin - Gross margin increased to$823.0 million in Q3 2024, with adjusted gross margin percentage rising to 84.9% from 84.4% in Q3 2023, driven by higher BRUKINSA sales mix[127] - Gross margin on product sales increased to 83.7% (GAAP) and 84.8% (adjusted) for the nine months ended September 30, 2024, up from 82.4% and 83.0% respectively in the prior-year period[145] Research and Development Expenses - Research and development expenses for Q3 2024 increased by 9.5% to $496.2 million from$453.3 million in Q3 2023[119] - Research and development expenses increased 9.5% to 496.2 million in Q3 2024, with external R&D expenses up 8.9% to 171.0 million and internal R&D expenses up 9.8% to $325.1 million[129][131] - Research and development expense increased by 9.9$1,411.3 million, with external R&D expenses rising by 14.3% to 501.2 million[146] - Adjusted R&D expenses for Q3 2024 were 405.5 million, compared to $396.1 million in Q3 2023[156] Selling, General, and Administrative Expenses - Selling, general, and administrative expenses for Q3 2024 rose by 24.5$455.2 million from $365.7 million in Q3 2023[119] - Selling, general and administrative expenses increased 24.5$455.2 million in Q3 2024, primarily due to commercial expansion for BRUKINSA in the U.S. and Europe[132][134] - Selling, general and administrative expenses increased by 21.7% to $1,326.4 million, primarily due to commercial expansion for BRUKINSA in the U.S. and Europe[151] - Adjusted operating expenses for Q3 2024 were$786.3 million, compared to $704.6 million in Q3 2023[156] Pipeline and Regulatory Updates - The company expanded its oncology pipeline with four new molecular entities (NMEs) entering clinical trials in Q3 2024, bringing the year-to-date total to eight[113] - TEVIMBRA received positive opinions from the European Medicines Agency for extended authorization in gastric and esophageal cancers[114] - The FDA granted Fast Track Designation to BGB-16673 for relapsed or refractory CLL or small lymphocytic lymphoma[116] Financial Position and Cash Flow - The company achieved$1 billion in quarterly total revenue for Q3 2024, marking its second consecutive quarter of positive non-GAAP operating income[113] - Adjusted income from operations in Q3 2024 was $65.6 million, compared to a loss of$16.3 million in Q3 2023[156] - Cash, cash equivalents, and restricted cash as of September 30, 2024, were $2.7 billion, down from$3.2 billion as of December 31, 2023[157] - Net cash used in operating activities improved by $720.0 million in the nine months ended September 30, 2024, compared to the prior year period[162] - Net cash used in investing activities was$454.7 million in the nine months ended September 30, 2024, compared to $122.6 million provided in the prior year period[163] - Net cash provided by financing activities was$198.0 million in the nine months ended September 30, 2024, compared to $69.4 million in the prior year period[164] - The company expects to repay approximately$863.8 million of loans in the next 12 months and plans to refinance them[165] - The company had $0.8 billion in cash remaining from the STAR Offering proceeds as of September 30, 2024[160] Contractual Obligations and Commitments - Total contractual obligations amount to$1.755 billion, with $1.125 billion due in the short term and$630.8 million in the long term[173] - Operating lease commitments total $55.4 million, with$4.6 million due in the short term and $50.8 million in the long term[173][174] - Non-cancellable purchase commitments amount to$155.9 million, with $125.9 million related to inventory from Amgen[175] - Total debt obligations due in the next twelve months are$863.8 million, with long-term debt obligations at $187.5 million[176] - Remaining co-development funding commitment under the Amgen collaboration is$379.1 million[179] - Capital commitments for property, plant, and equipment acquisition total $66.2 million[181] Interest and Currency Impact - Interest income, net decreased by 30.7$40.0 million due to lower interest rates on cash and cash equivalents[152] - A 100-basis point increase in interest rates would increase annual pre-tax interest expense by $7.4 million[185] - RMB appreciated approximately 1.1$45.3 million, primarily due to U.S., Switzerland, and China tax expenses[154] - Adjusted cost of sales for products in Q3 2024 was $149.7 million, compared to$93.0 million in Q3 2023[156]