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3月19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 ...

行业评级： | 报告期：2025.3.3-2025.3.16 | | | --- | --- | | 投资评级 | 看好 | | 评级变动 | 维持评级 | 医药生物行业双周报 2025 年第 6 期总第 129 期 创新和出海仍是全年投资主线之一 近期关注消费医疗板块 行业回顾 本报告期医药生物行业指数涨幅为 2.85%，在申万 31 个一级行业中 位居第 21，跑输沪深 300 指数（3.00%）。从子行业来看，线下药店、 医药流通涨幅居前，涨幅分别为 8.35%、4.05%；医疗设备跌幅居前， 跌幅为 0.08%。 行业走势： 估值方面，截至 2025 年 3 月 14 日，医药生物行业 PE（TTM 整体法， 剔除负值）为 27.31x（上期末为 26.54x），估值上行，低于均值。医 药生物申万三级行业 PE（TTM 整体法，剔除负值）前三的行业分别 为诊断服务（103.77x）、医院（43.66x）、其他医疗服务（36.92x）， 中位数为 28.51x，医药流通（15.99x）估值最低。 XXXX@gwgsc.com 本报告期，两市医药生物行业共有 28 家上市公司的股东净减持 82.05 亿元 ...

Investment Rating - The report provides a positive outlook for the company, indicating a strong performance in the upcoming year with expectations of achieving GAAP net profit in 2025 [6][22]. Core Insights - The company is expected to achieve a revenue of $3.81 billion in 2024, representing a year-on-year growth of 55%, with a significant reduction in GAAP operating losses to $568 million [3][13]. - The core products are experiencing accelerated growth, with sales of Baiyueze® (Zebutinib) reaching $2 billion in 2024, a 106% increase year-on-year, and Bai Ze An® (Tislelizumab) sales at $621 million, a 16% increase [4][16][17]. - The company is entering a critical phase with multiple clinical data readouts expected, including promising results from its Bcl-2 inhibitor Sonrotoclax for treating CLL [5][19]. - The company has provided clear profit guidance for 2025, expecting to achieve a GAAP net profit, with projected revenues between 352 billion to 381 billion RMB, reflecting a growth of 29.35% to 40% [6][23]. Summary by Sections Revenue Growth and Loss Reduction - The company reported a strong revenue performance with a projected revenue of $3.81 billion for 2024, a 55% increase year-on-year, and a significant reduction in GAAP operating losses [3][13]. - Non-GAAP operating profit is expected to be $45.36 million, marking a turnaround from previous losses [3][13]. Core Product Performance - Bai Ze An® (Tislelizumab) sales are projected at $621 million for 2024, a 16% increase, with ongoing regulatory reviews for new indications [4][16]. - Baiyueze® (Zebutinib) achieved sales of $2 billion, a 106% increase, with strong market share growth in the US and Europe [4][17][18]. Clinical Pipeline and Data Readouts - The company is advancing its clinical pipeline with 13 new molecules entering clinical trials in 2024, significantly higher than the previous year [5][21]. - Key clinical trials for Sonrotoclax and other products are expected to yield important data in 2025, potentially leading to accelerated approval applications [5][19]. Profit Guidance for 2025 - The company has set a clear profit guidance for 2025, expecting to achieve a GAAP net profit, with revenues projected between 352 billion to 381 billion RMB [6][23]. - The anticipated gross margin for 2025 is between 80% to 90%, indicating strong profitability potential [23].

Investment Rating - The report provides a positive outlook for the company, indicating a strong performance and growth potential, with expectations of achieving GAAP net profit in 2025 [6][22]. Core Insights - The company is expected to achieve a revenue of $3.81 billion in 2024, representing a year-on-year growth of 55%, with a significant reduction in GAAP operating losses [3][13]. - The core products are experiencing accelerated growth, with sales of Baiyueze® (Zebutinib) reaching $2 billion in 2024, a 106% increase year-on-year, and Bai Ze An® (Tislelizumab) sales at $621 million, a 16% increase [4][16][17]. - The company has entered a new phase of clinical data readouts, with 13 new molecules entering clinical trials in 2024, significantly higher than the previous year [5][21]. Summary by Sections Revenue Growth and Profitability - The company reported a projected revenue of $3.81 billion for 2024, with a 73% increase in product revenue driven by the sales of Baiyueze® and Bai Ze An® [3][13]. - The GAAP operating loss is expected to decrease to $568 million, a reduction of $640 million year-on-year, while non-GAAP operating profit is projected at $45.36 million [3][13]. Core Product Performance - Bai Ze An® sales are projected at $621 million for 2024, with ongoing FDA reviews for new indications, while Baiyueze® sales are expected to reach $2 billion, with significant market share growth in Europe [4][16][17]. - The company is solidifying its leading position in the CLL market, with Baiyueze® being the most widely approved BTK inhibitor globally [18]. Clinical Pipeline and Future Prospects - The company is advancing multiple clinical trials, including the Bcl-2 inhibitor Sonrotoclax, with data readouts expected in 2025 for various indications [5][19]. - The company has provided clear guidance for 2025, expecting a revenue range of 35.2 to 38.1 billion RMB, with a gross margin of 80%-90% and positive cash flow from operations [22][23].

Investment Rating - The report maintains a "Buy" rating for the company [7] Core Insights - The company is expected to achieve positive GAAP operating profit by 2025, with significant revenue growth and a reduction in net losses [1][13] - The company reported a total revenue of $3.81 billion for 2024, a year-on-year increase of 55%, and a net loss of $645 million, which is a 27% reduction in losses compared to the previous year [1][14] - The adjusted operating profit for 2024 was $45.36 million, marking the first annual non-GAAP operating profit [1][7] Financial Performance - In 2024, the company's GAAP and non-GAAP R&D expenses were $1.953 billion and $1.668 billion, respectively, with R&D expense ratios decreasing by 21 percentage points and 20 percentage points year-on-year [2] - The sales and management expenses for 2024 were $1.831 billion and $1.550 billion, with corresponding expense ratios decreasing by 13 percentage points and 12 percentage points year-on-year [2] - For Q4 2024, R&D expenses were $542 million, with an R&D expense ratio of 48%, a 30% decrease year-on-year [3] Product Performance - The core product, Zebutinib, saw global sales of $2.64 billion in 2024, a 105% year-on-year increase, with Q4 sales reaching $828 million, also a 100% increase year-on-year [4] - The sales in the U.S. for Zebutinib were $2 billion for the full year 2024, a 106% increase year-on-year, with Q4 sales of $616 million, a 97% increase year-on-year [4][19] - The company’s other product, Tislelizumab, generated total revenue of $621 million in 2024, a 16% year-on-year increase [5][23] Clinical Development - The development plans for BGB-16673 and Sonrotoclax are progressing steadily, with clinical trials expected to start in 2025 [6] - Tislelizumab has received new indications for reimbursement in 2024, expanding its market presence [5][20] Revenue Forecast - The revenue forecasts for 2024-2026 have been adjusted upwards, with expected revenues of $27.214 billion, $37.517 billion, and $45.024 billion respectively [7][11] - The net profit forecast for 2025 has been revised to $703 million, with a further increase to $4.010 billion in 2026 [7][11]

Investment Rating - The report maintains a "Buy" rating for the company [7] Core Insights - The company is expected to achieve positive GAAP operating profit by 2025, with significant revenue growth and a reduction in net losses [1][13] - The company reported total revenue of $3.81 billion for 2024, a year-on-year increase of 55%, and a net loss of $645 million, which is a 27% reduction in losses compared to the previous year [1][14] - The adjusted operating profit for 2024 was $45.36 million, marking the first annual non-GAAP operating profit [1][7] Financial Performance - In 2024, the company's GAAP and non-GAAP R&D expenses were $1.953 billion and $1.668 billion, respectively, with R&D expense ratios decreasing by 21 percentage points and 20 percentage points year-on-year [2] - The sales and management expenses for 2024 were $1.831 billion and $1.550 billion, with corresponding expense ratios decreasing by 13 percentage points and 12 percentage points year-on-year [2] - For Q4 2024, R&D expenses were $542 million, with an R&D expense ratio of 48%, a 30% decrease year-on-year [3] Product Performance - The core product, Zebrutinib, saw global sales of $2.64 billion in 2024, a 105% year-on-year increase, with Q4 sales reaching $828 million, also a 100% increase year-on-year [4] - The sales in the U.S. for Zebrutinib in 2024 were $2 billion, a 106% increase year-on-year, with Q4 sales of $616 million, a 97% increase year-on-year [4][19] - The company’s other product, Tislelizumab, generated total revenue of $154 million and $621 million in Q4 2024 and for the full year, respectively, with year-on-year growth of 20% and 16% [5][23] Clinical Development - The development plans for BGB-16673 and Sonrotoclax are progressing steadily, with clinical trials expected to start in 2025 [6] - The company has received new indications for Tislelizumab, which have been included in the 2024 medical insurance directory, expanding its market presence [5][20] Cost Management - The company has successfully reduced its sales and management expense ratio to 45% in Q4 2024, down from the previous year, indicating effective cost management [26] - The overall sales and management expenses for 2024 were $1.831 billion, with a ratio of 48%, reflecting a decrease in costs [26]

Investment Rating - The report maintains a "Buy" rating for the company [7] Core Insights - The company is expected to achieve positive GAAP operating profit by 2025, with several early-stage molecules in the solid tumor field progressing towards proof of concept [1] - Total revenue for 2024 is projected at $3.81 billion, representing a 55% year-over-year increase, while net loss is expected to narrow to $645 million, a 27% improvement compared to the previous year [1][13] - The company has achieved its first annual non-GAAP operating profit, with adjusted operating profits of $45.36 million and $78.60 million for the full year and Q4 of 2024, respectively [1][2] Financial Performance - In 2024, the company reported GAAP and non-GAAP R&D expenses of $1.95 billion and $1.67 billion, respectively, with R&D expense ratios decreasing by 21 percentage points and 20 percentage points year-over-year [2] - Sales and management expenses for 2024 were $1.83 billion and $1.55 billion, with corresponding expense ratios of 48% and 41%, showing a year-over-year decrease of 13 percentage points and 12 percentage points [2] - For Q4 2024, R&D expenses were $542 million, with an R&D expense ratio of 48%, down 30 percentage points year-over-year [3] Product Performance - The core product, Zebrutinib, saw global sales of $2.64 billion in 2024, a 105% increase year-over-year, with Q4 sales reaching $828 million, also up 100% year-over-year [4] - In the U.S., Zebrutinib's sales for Q4 and the full year were $616 million and $2 billion, respectively, reflecting year-over-year growth of 97% and 106% [4] - The company’s other product, Tislelizumab, generated total revenue of $154 million and $621 million for Q4 and the full year of 2024, marking a 20% and 16% increase year-over-year [5][23] Clinical Development - The development plans for BGB-16673 and Sonrotoclax are progressing steadily, with Phase III clinical trials expected to start in 2025 [6] - Tislelizumab has been included in the 2024 medical insurance directory for two new indications, expanding its global footprint [5] Revenue Forecast - Revenue forecasts for 2024-2026 have been adjusted upwards to $27.21 billion, $37.52 billion, and $45.02 billion, respectively, reflecting the company's strong growth trajectory [7] - The projected net profit for 2025-2026 has been revised to $703 million and $4.01 billion, respectively [7]

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical industry [7] Core Insights - The report emphasizes the leadership of Chinese companies in the PD-(L)1 bispecific antibody sector, highlighting it as a representative technology platform for new drug development in China [21][13] - The overall performance of the pharmaceutical sector has shown a 1.77% increase, outperforming both the ChiNext Index and the CSI 300 Index during the week of March 10-14 [13][14] Summary by Sections Recent Performance - The market experienced an upward trend with a notable surge on Friday, reflecting a shift from technology to non-technology sectors, particularly in consumer healthcare and policies related to the three-child policy [2][14] - The report notes that while innovative drugs and AI healthcare showed signs of correction, other themes such as consumer healthcare and small-cap innovations in Hong Kong gained traction [2][14] Future Outlook - In the short to medium term, the focus is on identifying opportunities in consumer healthcare, particularly those with attributes appealing to children and those positioned for consumption upgrades [15] - For 2025, the report anticipates improvements in the pharmaceutical payment sector due to supportive policies for commercial health insurance, indicating a gradual accumulation of positive changes [15] Strategic Allocation Thoughts - The report outlines two main strategies for investment: 1. **Pharmaceutical Style Rhythm**: Focus on consumer healthcare companies like Angelalign and Aier Eye Hospital, and innovative drug companies such as Innovent Biologics and BeiGene [16] 2. **Pharmaceutical Industry Logic**: Emphasizes the commercialization of innovative drugs and the integration of new technologies, with a focus on companies like CStone Pharmaceuticals and Zymeworks [17][19] Key Companies to Watch - The report suggests monitoring companies involved in PD-(L)1 bispecific antibodies, including CanSino Biologics, Innovent Biologics, and I-Mab Biopharma, as they are positioned at the forefront of clinical advancements [21][34]

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2025年3月27日（香港時間）舉行，以（其中包括）審議及批准本公司及其 附屬公司截至2024年12月31日止全年業績及根據香港聯合交易所有限公司證券上 市規則（「香港上市規則」）刊發全年業績。本公司先前於2025年2月27日公佈其截 至2024年12月31日止全年業績，並以提交表格10-K的方式將其全年業績送交美國 證券交易委員會（「美國證券交易委員會」）存案。本公司根據香港上市規則刊發的 全年業績與本公司先前已公佈並送交美國證券交易委員會存案者相同，惟根據香 港上市規則所要求的指定附加資料及將本公司的全年業績從美國公認會計原則與 國際財務報表準則進行核對的結果除外。 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） 香港，2025年3月14日 ...

如該公告所披露，2018員工購股計劃使合資格僱員可按市價15%折讓申購股份 （包括以美國存託股份的形式）。僱員可於認購期結束後購買股份，購股資金可從 其認購期內所得薪金中扣除。 公司謹此向其股東告知並宣佈，截至2024年9月3日至2025年2月28日之認購期的 最後一日，合共73,492股美國存託股份由3,356名參與者根據2018員工購股計劃購 買（「所購美國存託股份」）。所購美國存託股份涉及的股份數目為955,396，代表於 本公告之日本公司已發行股份總數的約0.068%。所購美國存託股份的詳情載列如 下： 授出日期╱認購期首日： 2024年9月3日 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） 員工購股計劃項下的股份購買及澄清公告 員工購股計劃項下的股份購買 本公告乃根據上市規則第17.06A、17.06B以及17.06C條作出。茲提述本公 ...