Revenue Growth and Performance - Total revenue for Q3 2024 increased to $1,001.6 million, up 28.2% from $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% increase from $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% to $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% to $690.3 million in Q3 2024, with U.S. revenue up 86.5% to $503.7 million and Europe revenue surging 217.2% to $97.3 million[123] - BRUKINSA global revenue increased by 107.0% to $1,816.2 million, with U.S. revenue growing by 111.0% to $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% to $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% to $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% to $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% to $455.2 million from $365.7 million in Q3 2023[119] - Selling, general and administrative expenses increased 24.5% to $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% to $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% against the U.S. dollar in the nine months ended September 30, 2024[187] - Inflation has not had a material effect on the company's results of operations during the nine months ended September 30, 2024[190] Tax and Cost of Sales - Income tax expense increased to $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]

Financial Performance - Total revenue for Q3 2024 reached $1.00 billion, representing a 28% increase compared to $781.3 million in Q3 2023[7] - Product revenue net amount was $993.4 million, a 67% increase from $595.3 million in the same quarter last year[7] - Non-GAAP operating profit for Q3 2024 was $65.6 million, a significant improvement of 502% compared to a loss of $16.3 million in Q3 2023[7] - GAAP operating loss decreased to $120.3 million, a 10% improvement from a loss of $134 million in Q3 2023[7] - Collaboration revenue net amount fell to $8.2 million, a 96% decrease from $186 million in the same quarter last year[7] - GAAP net loss for Q3 2024 was $121 million, compared to a net profit of $215 million in Q3 2023, primarily due to non-operating income from a previous arbitration settlement[26] - Total revenue for the nine months ended September 30, 2024, was $2.68 billion, compared to $1.82 billion for the same period in 2023, reflecting a 47% year-over-year growth[33] - Cash provided by operating activities for Q3 2024 was $18.8 million, an increase of $26.7 million compared to the same period last year, driven by improved non-GAAP operating profit[28] - The company experienced a net cash inflow from operating activities of $188.4 million in Q3 2024, compared to a cash outflow of $78.2 million in Q3 2023[35] Product Sales and Market Performance - Core product Baiyueze® global sales amounted to $690 million, contributing to the company's leading position in the chronic lymphocytic leukemia (CLL) field[5] - Baiyueze® sales in the US reached $504 million in Q3 2024, a year-over-year increase of 87%, with over 60% of the quarterly growth driven by its use in chronic lymphocytic leukemia (CLL) patients[8] - In Europe, Baiyueze® sales amounted to $97 million in Q3 2024, representing a 217% year-over-year increase, primarily due to market share gains in Germany, Italy, Spain, France, and the UK[8] - Bai Za An® (Tislelizumab) sales reached $163 million in Q3 2024, a 13% year-over-year increase[10] Research and Development - R&D expenses for Q3 2024 were $496.2 million, a 9% increase from $453.3 million in Q3 2023, attributed to advancing clinical projects[24] - The company has implemented an internal innovation strategy for rapid concept validation to explore clinical potential efficiently[5] - New molecular entities (NME) entering clinical development include BGB-B2033 and BGB-53038, with potential for significant market impact in oncology[17][20] - The clinical project for Sonrotoclax (BCL2 inhibitor) has enrolled over 1,300 patients, with ongoing trials expected to complete patient enrollment by Q1 2025[14] - BGB-16673 (BTK CDAC) has enrolled over 350 patients, with a Phase 3 trial for R/R CLL expected to start in H1 2025[15] Operational Efficiency and Strategy - The company aims to have over 10 new molecular entities (NME) enter clinical development by the end of the year, with 4 NMEs already in clinical development this quarter[5] - The company is expanding its oncology product pipeline and enhancing global commercialization capabilities for multiple promising anti-cancer drugs[6] - The company is committed to improving global patient accessibility and advancing treatment options for various cancers[6] - The company expects to continue leveraging operational efficiencies to improve margins and reduce losses in future quarters[26] Financial Metrics and Adjustments - GAAP gross margin for Q3 2024 was 83%, down from 84% in the same period last year, while adjusted gross margin increased to 85% from 84%[23] - Adjusted R&D expenses for the nine months ended September 30, 2024, were $1,193,494 thousand, up from $1,121,577 thousand in 2023, indicating a year-over-year growth of approximately 6.4%[38] - Adjusted operating expenses for the nine months ended September 30, 2024, totaled $2,310,299 thousand, compared to $2,044,831 thousand in 2023, representing an increase of about 13%[39] - The company’s non-GAAP financial metrics are intended to provide a more comprehensive understanding of its operational performance, supplementing GAAP data rather than replacing it[36] Leadership and Organizational Changes - The company appointed Matt Shaulis as General Manager for North America and Shalini Sharp as a board member to strengthen its global leadership team[21] Cash and Assets - Cash and cash equivalents as of September 30, 2024, were $2.71 billion, down from $3.19 billion at the end of 2023[34] - Total assets increased slightly to $5.83 billion as of September 30, 2024, compared to $5.81 billion at the end of 2023[34] - The company’s total liabilities rose to $2.39 billion as of September 30, 2024, from $2.27 billion at the end of 2023[34]

Financial Performance - Total revenue for Q3 2024 was $1,002 million, a 28% increase from $781 million in Q3 2023, primarily driven by BRUKINSA sales growth in the U.S. and Europe[15]. - Net product revenues for Q3 2024 were $993 million, up 67% from $595 million in Q3 2023, largely due to increased BRUKINSA sales[16]. - GAAP net loss for Q3 2024 was $121,350,000, compared to a net income of $215,413,000 in Q3 2023[30]. - The company reported an operating income of $66,000,000 on an adjusted basis for Q3 2024, an increase of $82,000,000 from the prior-year period[21]. - Adjusted income from operations was $65,630 thousand in Q3 2024, compared to a loss of $(16,339) thousand in Q3 2023, marking a 502% increase[3]. Sales Performance - BRUKINSA generated $690 million in global revenue for Q3 2024, with U.S. sales reaching $504 million (87% growth) and European sales totaling $97 million (217% growth) compared to the prior year[5]. - TEVIMBRA sales reached $163 million in Q3 2024, reflecting a 13% increase compared to the same period last year[6]. - Total revenues for Q3 2024 were $1,001,599,000, a 28% increase from $781,308,000 in Q3 2023[30]. - Product revenue for Q3 2024 was $993,447,000, up 67% from $595,290,000 in the prior-year period[30]. Expenses and Costs - Research and development expenses for Q3 2024 were $496,179,000, a 9% increase from $453,259,000 in Q3 2023[30]. - Selling, general and administrative expenses for Q3 2024 rose to $455,223,000, a 24% increase compared to $365,708,000 in Q3 2023[30]. - Total operating expenses for Q3 2024 were $951,402,000, a 16% increase from $818,967,000 in Q3 2023[30]. - GAAP cost of sales for products was $170,462, up from $96,309 in the previous year[35]. - Adjusted operating expenses for the three months ended September 30, 2024, were $786,282, compared to $704,639 in the same period last year[35]. Cash Flow and Assets - Cash provided by operations for Q3 2024 was $188,000,000, an increase of $267,000,000 over the prior-year period[24]. - Net cash provided by operating activities for the three months ended September 30, 2024, was $188,369, compared to a net cash used of $(78,150) in the same period last year[32]. - Cash, cash equivalents, and restricted cash at the beginning of the period was $2,617,931, down from $3,421,574[32]. - Cash, cash equivalents, and restricted cash at the end of the period was $2,713,428, down from $3,080,892[32]. - The company’s total assets as of September 30, 2024, were $5,830,860,000, compared to $5,805,275,000 as of December 31, 2023[31]. Liabilities - The company’s total liabilities increased to $2,394,787,000 as of September 30, 2024, from $2,267,948,000 as of December 31, 2023[31]. Operational Highlights - The company is on track to enter 10+ new molecular entities (NMEs) into clinical trials by the end of 2024, with four NMEs entering the clinic in Q3 2024[1]. - The five-year follow-up results from the Phase 3 SEQUOIA study showed an 80% progression-free survival rate for BRUKINSA in treatment-naïve CLL patients[5]. - The company has strengthened its global leadership team with new appointments, enhancing its operational capabilities[14]. Non-GAAP Measures - The company maintains a non-GAAP policy to provide additional insights into its operating performance, excluding non-cash items and special events[33].

Group 1 - BeiGene, Ltd. (NASDAQ: BGNE) continues to perform well with its PD-1 inhibitor drug TEVIMBRA (tislelizumab) for treating patients with solid tumors [2] - The company is in the process of possibly expanding its market presence and product offerings [2] Group 2 - The Biotech Analysis Central service provides in-depth analysis of various pharmaceutical companies, including a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [2] - The service aims to assist healthcare investors in making informed decisions through live chat and a range of analysis and news reports [2]

FF301 | 2. 股份分類 | 其他分類 (請註明) | 股份類別 | 其他類別 (請註明) | | 於香港聯交所上市 (註1) | | 否 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | N/A | 說明 | 非指定股份 | | | | | | | | | 法定/註冊股份數目 | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 USD | | 0.0001 | USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 500,000,000 USD | | 0.0001 | USD | | 50,000 | 本月底法定/註冊股本總額： USD 1,000,000 第 1 頁 共 10 頁 v 1.1.0 FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2024年10月31日 狀態: 新提交 致：香港交易及結算所有限公 ...

A 股代码：688235 A 股简称：百济神州 公告编号：2024-025 港股代码：06160 港股简称：百济神州 美股代码：BGNE 百济神州有限公司 关于召开 2024 年第三季度业绩说明会的公告 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。 重要内容提示： 1、会议召开时间：2024 年 11 月 14 日(星期四) 上午 09:00-10:00 2、会议召开地点：上海证券交易所上证路演中心（网址： https://roadshow.sseinfo.com/） 3、会议召开方式：上证路演中心网络互动 4、投资者可于 2024 年 11 月 7 日(星期四) 至 11 月 13 日(星期 三)16:00 前登录上证路演中心网站首页点击"提问预征集"栏目或通 过公司邮箱 ir@beigene.com 进行提问。公司将在说明会上对投资者普 遍关注的问题进行回答。 百济神州有限公司（以下简称"公司"）将于 2024 年 11 月 13 日 发布公司 2024 年第三季度报告，为便于广大投资者更全面深入地了 解公司 202 ...

第 1 頁 共 7 頁 v 1.3.0 FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 百濟神州有限公司 (於開曼群島註冊成立的有限公司) 呈交日期： 2024年11月1日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 不適用 | | | 於香港聯交所上市 | 是 | | | | 證券代號 (如上市) | 06160 | 說明 | | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | 事件 | | 已發行股份（不包括庫存股份）變動 | ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 百濟神州有限公司 (於開曼群島註冊成立的有限公司) 呈交日期： 2024年10月31日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | | 證券代號 (如上市) | 06160 | 說明 | | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | | ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 百濟神州有限公司 (於開曼群島註冊成立的有限公司) 呈交日期： 2024年10月30日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | | 證券代號 (如上市) | 06160 | 說明 | | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | | ...

承董事會命 百濟神州有限公司 主席 歐雷強先生 香港，2024年10月29日 於本公告日期，本公司董事會包括主席兼執行董事歐雷強先生、非執行董事 王曉東博士，以及獨立非執行董事Olivier Brandicourt博士、Margaret Han Dugan 博士、Michael Goller先生、Anthony C. Hooper先生、Ranjeev Krishana先生、 Alessandro Riva博士、Corazon (Corsee) D. Sanders博士、Shalini Sharp女士及 易清清先生。 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） 審計委員會會議日期 百濟神州有限公司（「本公司」）謹此公佈，本公司董事會（「董事會」）審計委員會 會議將於2024年11月12日（香港時間）舉行，以（其中包括）審議及批准本公司及 其附屬公 ...