美国证券交易委员会 百济神州有限公司 （注册人章程中载明的准确名称） Washington, D.C. 20549 ___________________________________________________________ 表格 10-Q ___________________________________________________________ （选择一项） ☒ 根据 1934 年证券交易法第 13 条或第 15（d）条编制的季度报告 截至 2025 年 3 月 31 日的季度期间 或 ☐ 根据 1934 年证券交易法第 13 条或第 15（d）条编制的过渡报告 过渡期从 至 交易委员会档案编号：001-37686 开曼群岛 98-1209416 （注册成立或组织所在的州或其他司法管辖区） （美国国家税务局雇主身份识别号码） c/o Mourant Governance Services (Cayman) Limited 94 Solaris Avenue, Camana Bay Grand Cayman （主要行政办事处地址） （邮政编码） 开曼群岛 KY1-1108 +1 (345 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 BeiGene, Ltd. 百濟神州有限公司 （於開曼群島註冊成立的有限公司） （股份代號：06160） 內幕消息 百濟神州有限公司 截至2025年3月31日止三個月未經審核業績以及 業務進展最新情況 本公告乃根據香港聯合交易所有限公司證券上市規則（「上市規則」）第13.09條及 根據證券及期貨條例（香港法例第571章）第XIVA部而刊發。 百濟神州有限公司（「本公司」或「百濟神州」）欣然公佈其截至2025年3月31日止 三個月的未經審核簡要合併財務業績以及業務進展最新情況。 本公司欣然公佈本公司及其附屬公司截至2025年3月31日止三個月未經審核簡要 合併財務業績（「第一季度業績」）以及2025年第一季度關鍵業務亮點和重申2025年 年度財務指引（「業務進展」）。第一季度業績乃根據美國證券交易委員會的適用規 則刊發。 第一季度業績乃根據美國公認會計準則編製，而美國公認會計準則有別於國際財 務報告準則。 ...

A 股代码：688235 A 股简称：百济神州 公告编号：2025-021 港股代码：06160 港股简称：百济神州 美股代码：ONC 百济神州有限公司 2025年第一季度主要财务数据公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 特别提示： 本公告所载的百济神州有限公司（以下简称"百济神州"或"公司"）2025 年第一季度主要财务数据为初步核算数据，未经会计师事务所审计，具体数据以公 司 2025 年第一季度报告中披露的数据为准，提请投资者注意投资风险。 本公告财务数据按中国企业会计准则编制并呈列。 本公司已于 2025 年 5 月 7 日同步发布了根据美国公认会计原则及美国证券交 易委员会适用规则编制的截至 2025 年 3 月 31 日止第一季度未经审计财务业绩，提 请投资者注意与本公告区别。 1 一、2025 年第一季度主要财务数据和指标 R/R MZL和R/R FL；获得中国国家药品监督管理局（NMPA）批准用于治疗CLL/SLL、 WM、R/R MCL和R/R FL。百悦泽®是目前分别在美国和中国获批适应 ...

Core Viewpoint - BeiGene reported a 50.2% increase in Q1 2025 revenue to 8.048 billion yuan, with a net loss of 94.503 million yuan, driven by strong sales of its self-developed products [1][2]. Revenue Growth - Q1 product revenue reached 7.985 billion yuan, up 49.9% year-on-year, primarily due to the sales growth of the self-developed drug Brukinsa® (Zebutinib) and the sales of Tislelizumab and Amgen licensed products [1]. - Global sales of Brukinsa® totaled 5.692 billion yuan in Q1, a 63.7% increase year-on-year, solidifying its leadership in the hematologic oncology field [1][2]. - Sales in the U.S. amounted to 4.041 billion yuan, reflecting a 61.9% year-on-year growth, driven by increased demand, particularly in chronic lymphocytic leukemia (CLL) indications [1]. - European sales reached 836 million yuan, up 75.4% year-on-year, attributed to market share gains across major European markets [1]. Market Position - In China, sales totaled 590 million yuan, a 43.1% increase year-on-year, maintaining a leading market share in the BTK inhibitor market [2]. - Brukinsa® has been included in the National Medical Insurance Directory for all four approved indications in China [2]. - Sales of Tislelizumab reached 1.245 billion yuan in Q1, a 19.3% increase year-on-year, driven by new indications covered by insurance and increased hospital access [2]. Clinical Development - Brukinsa® is the only BTK inhibitor with the most extensive approved indications globally and offers flexible dosing options [2]. - The clinical development program for Brukinsa® has been conducted in over 30 countries with more than 35 trials involving approximately 7,100 patients [2]. - The global Phase III ALPINE trial demonstrated sustained progression-free survival (PFS) benefits for Brukinsa® compared to ibrutinib in treating relapsed or refractory CLL/SLL patients [3]. - The company continues to advance key research projects, including the global clinical trials for Sonrotoclax, a BCL2 inhibitor, in combination with Brukinsa® for CLL and other indications [3].

Core Insights - The company reported a total revenue of 8.048 billion yuan in Q1 2025, representing a year-on-year increase of 50.2% [1] - Product revenue reached 7.985 billion yuan, with a year-on-year growth of 49.9% [1] - The company achieved an operating profit of 151 million yuan, a significant improvement from a loss of 1.83 billion yuan in the same period last year [1] - The net loss attributable to the parent company was 94.503 million yuan, compared to a loss of 1.908 billion yuan in the previous year [1] - The growth in product revenue was primarily driven by increased sales of self-developed products Baiyueze® and Baizean® [1]

Group 1 - The core viewpoint of the articles highlights the financial performance and market position of BeiGene, a global biotechnology company focused on innovative drug development and commercialization [1][2] - As of May 7, BeiGene's stock closed at 238.5 yuan, down 7.92%, with a market-to-book ratio of 13.84 and a total market capitalization of 334.535 billion yuan [1] - The latest financial report for the year 2024 shows that BeiGene achieved a revenue of 27.214 billion yuan, representing a year-on-year increase of 56.19%, while the net profit was -4.978287 million yuan, a year-on-year decline of 25.87%, with a gross margin of 84.44% [1] Group 2 - As of March 31, 2025, BeiGene had 24,071 shareholders, a decrease of 7,486 from the previous count, with an average holding value of 352,800 yuan and an average shareholding of 27,600 shares per shareholder [1] - In comparison to industry averages, BeiGene's price-to-earnings (P/E) ratio (TTM) is -67.20, while the industry average is 57.27, indicating a significant divergence in valuation metrics [2] - The industry median P/E ratio is 38.99, while BeiGene's market capitalization stands at 334.535 billion yuan, positioning it among the larger companies in the biotechnology sector [2]

Financial Performance - Total revenues for Q1 2025 increased by 48.6% to $1.117 billion compared to $751.7 million in Q1 2024[94] - BRUKINSA global sales rose by 62.1% to $791.7 million, with U.S. sales growing by 60.2% to $563.2 million[95] - TEVIMBRA revenue increased by 17.8% to $171.2 million in Q1 2025 compared to $145.3 million in the prior-year period[96] - The company achieved GAAP profitability in Q1 2025, marking a significant turnaround from a net loss of $251.2 million in Q1 2024[92] - GAAP net income improved to $1.3 million in Q1 2025, compared to a loss of $251.2 million in the prior-year period[107] - Adjusted earnings per share (basic) for Q1 2025 was $0.10, compared to a loss of $0.11 in Q1 2024[108] Expenses and Costs - Operating expenses rose by 6.0% to $941.2 million, with R&D expenses increasing by 4.6% to $481.9 million[93] - Selling, general and administrative expenses increased by $31.9 million, or 7.5%, to $459.3 million for Q1 2025, primarily due to global commercial expansion efforts[103] - Selling, general and administrative expenses as a percentage of product sales decreased to 41.4% in Q1 2025 from 57.2% in the prior-year period[103] - Research and development expense increased by $21.2 million, or 4.6%, to $481.9 million for Q1 2025 from $460.6 million in Q1 2024[98] - External research and development expenses rose by $19.4 million, or 11.3%, to $190.8 million in Q1 2025, driven by advancing preclinical and early clinical programs[100] Cash and Debt Management - Cash, cash equivalents, and restricted cash totaled $2.53 billion as of March 31, 2025, down from $2.64 billion at the end of 2024[110] - Total debt decreased to $923.6 million as of March 31, 2025, from $1.02 billion at the end of 2024, with $97.1 million paid down in Q1 2025[110] - The company expects to repay approximately $763.5 million of loans in the next 12 months, with refinancing dependent on prevailing interest rates and credit spreads[116] - As of March 31, 2025, total debt obligations due in the next twelve months are $763.5 million, with long-term debt obligations at $160.2 million[123] - The company had $461.6 million in cash remaining related to the STAR Offering proceeds as of March 31, 2025[111] Revenue Sources - Collaboration revenue increased by 84.8% to $8.7 million in Q1 2025, driven by agreements with Novartis and Amgen[96] Operational Highlights - Gross margin on global product sales improved to 85.1% in Q1 2025, up from 83.3% in the same period last year[97] - Cash provided by operating activities improved by $352.7 million in Q1 2025 compared to Q1 2024, driven by significantly improved revenue and a $325.6 million increase in gross margin[113] - Net cash used in investing activities decreased to $121.9 million in Q1 2025 from $209.8 million in Q1 2024, primarily due to reduced capital expenditures[114] - Financing activities used $33.8 million in cash in Q1 2025, a significant decrease from $162.3 million provided in Q1 2024, mainly due to a net reduction in short-term debt borrowings[115] Strategic Initiatives - The company plans to host an Investor R&D Day on June 26, 2025, to discuss advancements in its late-stage pipelines[92] - The company secured shareholder approval to rename itself to BeOne Medicines Ltd. and to redomicile to Switzerland[92] Legal and Regulatory Developments - The U.S. Patent and Trademark Office invalidated all claims of Pharmacyclics LLC's U.S. Patent No. 11,672,803, benefiting the company's competitive position[89] Foreign Exchange Impact - The RMB appreciated approximately 0.6% against the U.S. dollar in Q1 2025, while it depreciated approximately 2.8% in the year ended December 31, 2024[132] - A hypothetical 10% appreciation in the U.S. dollar against the RMB would have resulted in an increase in foreign exchange loss of approximately $14.8 million as of March 31, 2025[133]

Financial Performance - Total revenue for Q1 2025 reached $1.12 billion, a 49% increase from $751.65 million in Q1 2024[8] - Product revenue for Q1 2025 was $1.11 billion, up 48% from $746.92 million in the same period last year[8] - GAAP operating profit for Q1 2025 was $11.1 million, a significant improvement from a loss of $261.35 million in Q1 2024, marking a 104% change[8] - Adjusted operating profit for Q1 2025 was $139.36 million, compared to a loss of $147.34 million in the previous year, representing a 195% increase[8] - The company achieved its first GAAP quarterly profit in Q1 2025, with a GAAP net profit of $1.27 million, compared to a loss of $251.15 million in Q1 2024[8] - The company reported a net profit of $0.00 per share in Q1 2025, an improvement from a loss of $0.19 per share in the same period last year[14] - The net profit for Q1 2025 was $1,270,000, a turnaround from a net loss of $251,150,000 in Q1 2024[32] Sales and Market Performance - Global sales of Brukinsa (Zebutinib) amounted to $792 million, reflecting a 62% year-over-year growth[7] - The U.S. remained the largest market, contributing $563 million in product revenue for Q1 2025, up from $351 million in the same quarter last year[9] - Baiyueze® sales in the U.S. reached $563 million in Q1 2025, a 60% increase year-over-year, primarily due to increased demand in CLL indications[13] - Baiyueze® is now approved in 75 markets globally, with recent expansions in Japan, Europe, and Brazil[17] Expenses and Costs - R&D expenses for Q1 2025 were $481.9 million, a 5% increase from $460.6 million in Q1 2024; adjusted R&D expenses rose 4% to $421.2 million[11] - SG&A expenses in Q1 2025 were $459.3 million, up 7% from $427.4 million in Q1 2024, with SG&A expenses accounting for 41% of product revenue, down from 57% year-over-year[12] - Operating expenses totaled $941,175,000 in Q1 2025, compared to $888,065,000 in Q1 2024, marking an increase of approximately 6%[32] Cash Flow and Assets - Cash and cash equivalents as of March 31, 2025, were $2,530,591,000, a slight decrease from $2,638,747,000 as of December 31, 2024[33] - Total assets amounted to $5,841,526,000 as of March 31, 2025, down from $5,920,910,000 at the end of 2024[33] - Net cash provided by operating activities was $44,082 thousand in Q1 2025, a significant improvement from a net cash used of $308,572 thousand in Q1 2024[34] - Cash used in investing activities was $121,941 thousand in Q1 2025, compared to $209,831 thousand in Q1 2024[34] Future Plans and Developments - The company plans to hold an investor R&D day on June 26, 2025, to discuss advancements in its late-stage hematologic and solid tumor pipeline[7] - The company expects to report proof of concept data in various projects related to antibody-drug conjugates, multispecific antibodies, and targeted protein degradation throughout the year[7] - The company expects to complete mid-term analysis for the Phase 3 MANGROVE trial for MCL treatment in the second half of 2025[23] - The company plans to submit a global accelerated approval application for Sotoclar in R/R MCL following data readout from a Phase 2 trial anticipated in late 2025[26] - Baiyueze® tablet formulation is anticipated to receive FDA and EU approval in the second half of 2025[23] Corporate Changes - The company has received shareholder approval to adopt a new English name, BeOne Medicines Ltd., and relocate its registered office to Switzerland[7] - The company has received shareholder approval to change its name to BeOne Medicines Ltd. and relocate its registered office to Switzerland, expected to be completed later this year[26]

Financial Reporting - BeiGene, Ltd. filed its 2024 Annual Report with the STAR Market of the Shanghai Stock Exchange on April 28, 2025[5]. - The STAR Annual Report includes financial information for the year ended December 31, 2024, prepared in accordance with PRC GAAP[6]. - Financial information prepared under U.S. GAAP is also included, highlighting differences between PRC GAAP and U.S. GAAP[6]. - The financial information in the report is intended to be furnished and not deemed "filed" under the Exchange Act[8]. Key Financial Metrics - The report contains details on gross profit margin ratio and research and development expenses allocated by key products[6]. Public Availability - The STAR Annual Report is publicly available in Chinese on the Shanghai Stock Exchange's website[7]. Strategic Insights - The report does not include any new product launches or market expansion strategies[5][6]. - No specific performance guidance or future outlook was provided in the current report[5][6]. - The report does not mention any mergers or acquisitions during the reporting period[5][6]. Signatory Information - The filing was signed by Chan Lee, Senior Vice President and General Counsel of BeiGene, Ltd.[16].

港股创新药板块盘初下挫，百济神州跌超6%，荣昌生物跌超5%，信达生物、药明生物、君实生物纷纷 下挫。 ...