目录 美国 证券交易委员会 Washington, D.C. 20549 表格 10-K/A 第一次修订 （选择一项） ☒ 根据 1934 年证券交易法第 13 条或第 15 条(d)节的年度报告 截至 2024 年 12 月 31 日的财政年度 或 ☐ 根据 1934 年证券交易法第 13 条或第 15 条(d)节的过渡报告 过渡期从 至 交易委员会递交编号：001-37686 BEIGENE, LTD. 百济神州有限公司 （注册人章程载明的确切名称） （注册成立或组建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） 开曼群岛 98-1209416 c/o Mourant Governance Services (Cayman) Limited 94 Solaris Avenue, Camana Bay Grand Cayman 开曼群岛 KY1-1108 （主要行政办事处地址，包括邮政编码） +1 (345) 949 4123 （注册人的电话号码，包括地区编码） 根据本法案第 12（b）条注册的证券： | 各类别名称 | 交易代码 | 各证券交易所名称 | | --- | --- | --- | ...

| 2). 就根據股份計劃授予參與人（發行人的董事除外）的股份獎勵或期權 | 2,626,663 | 0.189 % | USD | 9.54 | | | --- | --- | --- | --- | --- | --- | | 而發行新股或轉讓庫存股份 - 涉及新股 | | | | | | | （自願性披露）因合資格參與者（本公司董事除外） | | | | | | | 於2025 年2月 1 日至 2025 年2月28 日期間行使購股權而發行普通股 | | | | | | | 變動日期 2025年2月28日 | | | | | | | 3). 就根據股份計劃授予參與人（發行人的董事除外）的股份獎勵或期權 | 30,927 | 0.002 % | USD | 1.41 | | | 而發行新股或轉讓庫存股份 - 涉及新股 | | | | | | | （自願性披露）因合資格參與者（本公司董事除外） | | | | | | | 於2025年2月 1 日至 2025年2月28日期間行使購股權而發行普通股 | | | | | | | 變動日期 2025年2月28日 | | | | | | | 於下列日期結束時的結存 ...

Investment Rating - The report maintains a "Buy" rating for the company and raises the target price to USD 324 for US stocks, HKD 194 for Hong Kong stocks, and CNY 273 for A-shares [1][11]. Core Insights - The company's revenue guidance for 2025 is stronger than market expectations, reaffirming the GAAP operating profit guidance [1][3]. - The company achieved a product revenue of USD 1.118 billion in Q4 2024, representing a year-over-year increase of 77.3% and a quarter-over-quarter increase of 12.5% [2]. - The adjusted non-GAAP operating profit for Q4 2024 was USD 78.6 million, marking the third consecutive quarter of profitability [2]. - The strong overseas sales of the drug Zebutinib contributed to a gross margin of 85.6% in Q4 2024, an increase of 2.4 percentage points year-over-year [2]. Revenue Guidance - The total product revenue guidance for 2025 is set at USD 4.9-5.3 billion, reflecting a year-over-year growth of 29.6% to 40.2%, which exceeds both Visible Alpha's expectation of 27% and the previous forecast of 21% [3]. - GAAP operating expenses are projected to be USD 4.1-4.4 billion, aligning with market expectations [3]. Product Performance - Zebutinib's global sales reached USD 828 million in Q4 2024, showing a year-over-year growth of 100.5% and a quarter-over-quarter growth of 20% [4]. - The US sales of Zebutinib amounted to USD 616 million, a 96.7% increase year-over-year, while European sales reached USD 113 million, up 147.8% year-over-year [4]. Research and Development Progress - The company is expected to have multiple research catalysts in 2025, including the announcement of global phase II data for Sonrotoclax in the second half of 2025 [5][10]. - The company plans to initiate several phase III clinical trials in 2025 for various indications [10]. Financial Projections - Revenue projections for 2025 are estimated at USD 4.972 billion, with a year-over-year growth of 30.5% [12][16]. - The company is expected to achieve a net profit of USD 81 million in 2025, transitioning from a loss in previous years [12][16].

Summary of Conference Call Records Industry Overview Agriculture Sector - Focus on the application of AI and low-altitude data technologies in agriculture, with a long-term positive impact on leading agricultural technology companies. Short-term effects are limited [1][2] - The pig farming industry is currently profitable, but capacity reduction has not yet begun. Pig prices are expected to fluctuate downwards in the first half of the year, with rising soybean meal prices increasing cost pressures. Recommended stocks include Muyuan Foods and Juxing Agriculture [1][4] Pet Food Industry - The impact of increased tariffs on pet food exports to the U.S. is limited, as major companies have established overseas production capabilities. Companies like Zhongchong and Petty are well-positioned to handle U.S. orders [1][5] - Guobao's brand upgrades for the Maifudi brand include the Buff series and goat milk meat series, enhancing brand recognition and product pricing [1][6][7] - Zhongchong and Petty plan to launch staple food products in 2025, indicating continued rapid growth in the industry [1][9] Planting and Seed Industry - The planting and seed sectors face uncertainty, with expectations for genetically modified crop promotion already priced in. High seed inventories and falling grain prices may lead to bottom-line profitability [1][10] Baijiu (Chinese Liquor) Sector - The baijiu sector is undergoing valuation recovery, with consumption demand during the Spring Festival showing differentiation, leading to market share concentration among leading companies. The price system for Feitian Moutai is stabilizing [1][11] - 2025 is expected to be a year for the baijiu industry to solidify its bottom, with the second quarter being particularly critical [1][12] Key Points and Arguments Agriculture Sector - The agricultural sector's performance post the 2025 Central Document is subdued, with traditional agriculture being stable and conservative language regarding genetically modified crops leading to some capital withdrawal [2] Pig Farming Industry - As of late February, the average price of pigs is approximately 14.5 yuan/kg, down about 10% from before the Spring Festival. Leading companies are achieving profits of around 100 yuan per pig, while excellent family farms can achieve profits of 150-200 yuan per pig [4] Pet Food Industry - The potential increase in tariffs on pet food exports to the U.S. is not expected to significantly impact overall profits, as the majority of companies have adapted their production strategies [5] Brand Upgrades in Pet Food - Guobao's Maifudi brand has undergone significant updates, including a shift in product naming and packaging, which may lead to the Buff series becoming a standalone brand [6][7] Baijiu Sector Trends - The baijiu sector is experiencing a recovery in valuation, with a stable price system for key products like Feitian Moutai. The market is expected to stabilize as core products find their positioning [11][12] Pharmaceutical Innovation - The innovative pharmaceutical sector is performing well, with companies like Heng Rui Pharmaceutical expected to launch nearly ten new products in the next two to three years, leading to explosive growth [3][17] - Bai Jie Shen Zhou is expected to achieve profitability in 2025, with significant revenue from its leading product, Zebu Tini [3][18] Investment Recommendations - Recommended stocks include Muyuan Foods and Juxing Agriculture in the pig farming sector, and Heng Rui Pharmaceutical in the pharmaceutical sector. The baijiu sector recommends high-end brands like Moutai and Wuliangye [1][14][17] Other Important Insights - The planting and seed industry requires close monitoring of new genetically modified crop data and U.S.-China trade relations affecting agricultural tariffs [1][10] - The pet food industry is expected to continue its rapid growth trajectory, with significant product launches planned for 2025 [1][9]

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical industry [7] Core Views - The report highlights the performance of the Shenwan Pharmaceutical Index, which decreased by 2.72% during the week of February 24-28, 2024, outperforming the ChiNext Index but underperforming the CSI 300 Index. It emphasizes the identification of high-growth pharmaceutical companies for potential investment opportunities in 2024 [12][19] Summary by Sections Recent Review - The market showed stability in the first half of the week, with a significant drop on Friday. The technology sector faced adjustments, while the steel and food & beverage sectors performed well. The report notes that innovative drugs and companies with strong performance metrics are favorable, while AI medical applications experienced some adjustments [2][13] Future Outlook - The report suggests focusing on two main areas: market mapping related to AI applications in healthcare and policy expectations from the Two Sessions, such as fertility policies. It also emphasizes the ongoing innovation in the pharmaceutical sector, including international expansion and commercialization of early-stage innovative products [3][14] Strategy Configuration - The report outlines two strategic approaches: 1. **Pharmaceutical Style Rhythm**: Focus on innovative drugs such as BeiGene, Kelun-Biotech, and others, as well as AI medical applications like International Medical and Meinian Health [4][15] 2. **Pharmaceutical Industry Logic**: Emphasizes the commercialization of innovative drugs, new technologies, and internationalization strategies, including companies like Innovent Biologics and Hengrui Medicine [6][16] High-Growth Company Analysis - The report lists several high-growth pharmaceutical companies based on their 2024 performance forecasts, including BeiGene and BGI Genomics, noting that companies with strong quarterly performance are likely to maintain high growth throughout the year [19][22]

目录 美国 证券交易委员会 Washington, D.C. 20549 表格 10-K （选择一项） ☒ 根据 1934 年证券交易法第 13 条或第 15 条(d)节的年度报告 截至 2024 年 12 月 31 日的财政年度 或 ☐ 根据 1934 年证券交易法第 13 条或第 15 条(d)节的过渡报告 百济神州有限公司 （注册人章程载明的确切名称） （注册成立或组建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 开曼群岛 KY1-1108 （主要行政办事处地址，包括邮政编码） +1 (345) 949 4123 过渡期从 至 交易委员会递交编号：001-37686 BEIGENE, LTD. （注册人的电话号码，包括地区编码） 根据本法案第 12（b）条注册的证券： | 各类别名称 | 交易代码 | 各证券交易所名称 | | --- | --- | --- | | 每股美国存托股份相当于 13 股普通股，每 ...

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2024年12月31日止三個月未經審核業績 及截至2024年12月31日止全年經審核業績以及業務進展 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2024年12月31日 止第四季度的未經審核綜合財務業績及截至2024年12月31日止全年的經審核綜 合財務業績以及業務進展。 本公司欣然公佈本公司及其附屬公司截至2024年12月31日第四季度未經審核綜合 財務業績（「季度業績」）及截至2024年12月31日止全年經審核綜合財務業績（「全 年業績」）以及關鍵業務進展、主要管線亮點、企業進展和2025年財務指引（「業務 進展 ...

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： 2025年2月27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 | | | | | 事 ...

审计委员会由四名成员构成，包括 Shalini Sharp 女士、Olivier Brandicourt 博士、Anthony C. Hooper 先生及 Corazon (Corsee) D. Sanders 博士。Shalini Sharp 女士为审计委员会主席。 特此公告。 A股代码：688235 A股简称：百济神州 公告编号：2025-009 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 关于董事会审计委员会主席变更的公告 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。 经百济神州有限公司（以下简称"公司"）董事会审议通过，自 2025 年 3 月 1 日起，Shalini Sharp 女士获委任为董事会审计委员会（以下简 称"审计委员会"）主席，Anthony C. Hooper 先生不再担任审计委员会 主席，但将继续担任审计委员会成员。 百济神州有限公司董事会 2025 年 2 月 28 日 1 ...

Financial Performance - In Q4 2024, total global revenue reached $1.1 billion, a 78% year-over-year increase, while total global revenue for the year reached $3.8 billion, a 55% year-over-year increase[9]. - In Q4 2024, product revenue reached $1,118,035, a 77% increase from $630,526 in Q4 2023[40]. - Total revenue for the year 2024 was $3,810,241, compared to $2,458,779 in 2023, reflecting a 55% year-over-year growth[40]. - Adjusted operating profit for Q4 2024 was $78,603, compared to a loss of $267,224 in Q4 2023, marking a 129% improvement; annual adjusted operating profit was $45,356, up from a loss of $752,473 in 2023[10]. - Net loss for Q4 2024 was $(151,881), compared to $(367,553) in Q4 2023, indicating a reduction in losses[40]. - For the full year 2024, GAAP net loss was $0.47 per share for common stock and $6.12 per ADS, an improvement from $0.65 and $8.45 in the previous year[32]. - Operating cash flow in Q4 2024 was $75 million, an increase of $297 million year-over-year, while the full year cash used in operations was $141 million, a decrease of $1 billion compared to the previous year[32]. Product Sales - Sales of Baiyueze® in Q4 2024 amounted to $828 million, a 100% year-over-year increase, with total sales for the year reaching $2.6 billion, a 105% year-over-year increase[9]. - Sales of Baiyueze® in the US for Q4 2024 were $616 million, a 97% year-over-year increase, with annual sales reaching $2 billion, up 106%[12]. - Baiyueze® sales in Europe for Q4 2024 were $113 million, a 148% increase year-over-year, with annual sales of $359 million, up 194%[12]. - Bai Ze An® sales for Q4 2024 were $154 million, a 20% increase year-over-year, with annual sales of $621 million, up 16%[15]. - Baiyueze® has been approved in over 70 markets globally, with more than 180,000 patients treated[11]. Research and Development - Six new molecular entities (NMEs) entered clinical development in Q4 2024, with a total of 13 for the year; multiple innovative solid tumor projects are expected to have data readouts in the first half of 2025[9]. - The company is leveraging its research and development platforms, including multispecific antibodies and antibody-drug conjugates, to accelerate future treatments in breast cancer, lung cancer, and gastrointestinal cancer[9]. - The company has a robust pipeline with over 1,800 patients enrolled in clinical trials for various indications, including R/R CLL and R/R MCL[17]. - The company plans to read out data from a Phase 3 study of Tarlatamab for small cell lung cancer in H1 2025[20]. - The company expects to enter clinical development for BG-60366 in Q4 2024, targeting EGFR mutations with strong efficacy[20]. Operational Expenses - R&D expenses for Q4 2024 were $542 million, a 10% increase from $494 million in Q4 2023, while annual R&D expenses reached $1.95 billion, up 10% from $1.78 billion[28][30]. - SG&A expenses for Q4 2024 were $505 million, a 21% increase from $418 million in Q4 2023, with annual SG&A expenses totaling $1.83 billion, also up 21% from $1.51 billion[28][30]. - Total GAAP operating expenses for 2024 reached $3,784,351, up from $3,286,595 in 2023, representing a 15.1% increase[49]. - Adjusted sales and marketing expenses for 2024 were $1,549,864, compared to $1,284,689 in 2023, reflecting a 20.7% increase[49]. Future Outlook - The company expects full-year 2025 revenue guidance to be between $4.9 billion and $5.3 billion, while reaffirming expectations for positive GAAP operating profit and positive cash flow from operations[9]. - The company anticipates strong growth in 2025, positioning it as a pivotal year for its operations[9]. - The company projects total revenue for 2025 to be between $4.9 billion and $5.3 billion, driven by strong growth from the product 百悦泽® in the U.S. and continued expansion in Europe and other key markets[33]. - GAAP operating expenses for 2025 are expected to be between $4.1 billion and $4.4 billion, with a projected gross margin in the range of 80% to 90%[33]. - The earnings call for Q4 2024 and full year results will be held on February 27, 2025, at 8 AM EST[34]. Corporate Developments - The company plans to utilize its new English name "BeOne" and has activated the new stock code ONC on NASDAQ[9]. - The company will change its NASDAQ ticker from "BGNE" to "ONC" pending shareholder approval[25]. - The company plans to submit a marketing application for Baiyueze® tablet formulation to the FDA and EU in the second half of 2025[16]. - The company has signed a settlement agreement with MSN Pharmaceuticals, allowing them to sell a generic version of Baiyueze® in the US no earlier than June 15, 2037[12]. - The company plans to present key data at the 2024 ASH annual meeting and the 2025 J.P. Morgan Healthcare Conference[25]. Strategic Focus - The company emphasizes its leadership position in the chronic lymphocytic leukemia (CLL) treatment market with Baiyueze®[9]. - The company emphasizes a data-driven strategy to maximize resource utilization and prioritize promising clinical candidates[14]. - 百济神州 is focused on developing innovative oncology drugs and enhancing drug accessibility and affordability globally[35]. - The company plans to utilize various social media platforms for significant disclosures in compliance with U.S. fair disclosure regulations[36]. - Forward-looking statements include expectations for future revenue, operating profit, cash flow, and gross margin, with actual results subject to various risks and uncertainties[37].