FF304 翌日披露報表 (股份發行人 ── 已發行股本變動及/或股份購回) 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2月27日 | 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(註11) | 是 | | | 證券代號 (如於香港聯交所上市) | | 06160 | 說明 | | | | | | | | 發行股份 | (註6及7) | | 股份數目 | | 已發行股份佔 有關股份發行前的 現有已發行股份數目 百分比 (註4、6及7) | | 每股發行價 (註1及7) | 上一個營業日 的每股收市價 (註5) | 發行價較市值的折讓/ 溢價幅度(百分比) (註7) | | 於下列日期開始時的結存(註2) | | 2024年1月31日 | | 1,240,530,734 | | | | | | | 1). 於股份獎勵計 ...

Investment Rating - The investment rating for the company is maintained at "Buy-A" [3] Core Views - The company is expected to achieve a revenue of 17.423 billion yuan in 2023, representing an increase of 82.1% year-on-year, with product revenue reaching 15.504 billion yuan, also up by 82.8% [1] - The company anticipates a significant narrowing of losses, with expected losses of 6.716 billion yuan in 2023, a reduction of 50.77% year-on-year [1] - The company is actively expanding its product pipeline and has made significant progress in both domestic and international markets [2][5] Summary by Sections Financial Performance - The company reported a projected revenue of 17.423 billion yuan for 2023, with a year-on-year growth of 82.1% [6] - The expected loss for 2023 is 6.716 billion yuan, which is a 50.8% improvement compared to the previous year [6] - The gross margin is projected to be 82.7% in 2023, slightly down from 86.0% in 2021 [6] Product Development - The global sales of Baiyueze (BTK inhibitor) are expected to reach 9.138 billion yuan in 2023, a remarkable increase of 138.7% [1] - Baiyueze has received approval for five indications in China and has expanded its global indications, further solidifying its market position [1] - The company is advancing its pipeline with multiple clinical trials, including sonrotoclax and BGB-16673, targeting various hematological malignancies [2] Market Expansion - The sales of Baizean (PD-1) are projected to be 3.806 billion yuan in 2023, with a year-on-year growth of 33.1% [2] - The company has received approval for 12 indications in the domestic market, with several more under review [2] - The international market presence is expanding, with multiple registration applications submitted across various regions [2]

內幕消息 百濟神州有限公司 截至2023年12月31日止三個月未經審核業績 及截至2023年12月31日止全年經審核業績以及 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2023年12月31日 止第四季度的未經審核綜合財務業績及截至2023年12月31日止全年的經審核綜 合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2023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2023年12月31日止全年經審核綜合財務業績（「全 年業績」）以及關鍵業務進展和管線亮點和2024年預計里程碑（「業務進展最新情 況」）。季度業績及全年業績乃根據美國證券交易委員會的適用規則刊發。 季度業績及全年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。 本公告附件一是本公司於2024年2月26日就季度業績及全年業績以及業務進展最 新情況發佈的新聞稿的全文（除另有規定外，下文所列全部金額均以美元 ...

Financial Performance - Total revenue for Q4 2023 reached $634 million, a year-over-year increase of 67%; total revenue for the full year 2023 was $2.5 billion, up 74% year-over-year[3] - In Q4 2023, the company's product revenue reached $630.5 million, a year-over-year increase of 86%, while total product revenue for the year was $2.2 billion, up 75% from the previous year[4] - The company reported total revenue of $2,458.8 million for the year ended December 31, 2023, a 73.6% increase from $1,415.9 million in 2022[24] - The company’s net loss for the year ended December 31, 2023, was $881.7 million, compared to a net loss of $2,003.8 million in 2022, representing a 56.0% improvement[24] - The company reported a decrease in cash used in operating activities, with $221.6 million for Q4 and $1.2 billion for the full year, compared to $318.2 million and $1.5 billion in the previous year[13] Product Sales and Market Growth - Global sales of BeiGene's flagship product, Brukinsa (Zebutinib), in Q4 2023 amounted to $413 million, representing a 135% year-over-year growth; total global sales for the full year reached $1.3 billion, a 129% increase year-over-year[3] - The total revenue from the U.S. market in Q4 2023 was $313.2 million, up from $155.4 million in the same quarter last year, indicating strong sales growth[6] - The company plans to maintain the sales growth trend of Bruton’s Tyrosine Kinase inhibitor in the U.S. market throughout 2024[6] Research and Development - BeiGene is advancing its hematology innovation pipeline, initiating four registrational trials for sonrotoclax, including a global Phase 3 trial for treatment of treatment-naive chronic lymphocytic leukemia (CLL)[3] - The company announced five new molecular entities (NMEs) entering clinical trials in 2023, including a potential best-in-class CDK4 inhibitor[5] - R&D expenses for Q4 2023 were $494 million, an 11% increase from $446 million in Q4 2022, while total operating expenses for the quarter rose by 18% to $912.4 million[9] - R&D expenses for Q4 2023 and the full year increased year-over-year, driven by investments in new technology platforms and drug models, with ongoing preclinical and early clinical projects advancing to later stages[11] - The company plans to initiate at least 10 first-in-human clinical trials for new molecular entities in 2024, including KRAS inhibitors and EGFR degraders[20] Regulatory Approvals and Product Development - The FDA approved an update to the label for the drug Bruton’s Tyrosine Kinase (BTK) inhibitor, further solidifying its position as the preferred treatment for relapsed or refractory chronic lymphocytic leukemia (CLL) patients[4] - The company expanded the global indications for Bruton’s Tyrosine Kinase inhibitor, receiving EU approval for treating adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies[4] - Baiyueze® is expected to receive FDA approval in March 2024 for use in combination with obinutuzumab for treating R/R FL patients[18] - The company expects to receive FDA approval for Tarelizumab for second-line ESCC treatment in the first half of 2024, with a PDUFA target review date of July 2024 for first-line treatment of unresectable, recurrent, locally advanced, or metastatic ESCC patients[19] Operational Efficiency - The company reduced its GAAP operating loss by 18% in Q4 and 33% for the full year, with adjusted operating losses decreasing by 28% and 47%, respectively[4] - The gross margin for Q4 2023 was 83.2%, up from 78.3% in the same quarter last year, attributed to higher sales of Bruton’s Tyrosine Kinase inhibitor[8] - GAAP operating loss for Q4 2023 was $(383,795) thousand, an improvement from $(468,622) thousand in Q4 2022, indicating a reduction of 18.1%[26] - Adjusted operating loss for Q4 2023 was $(267,224) thousand, compared to $(372,480) thousand in Q4 2022, showing a decrease of 28.3%[26] Strategic Initiatives - The company aims to solidify its leadership position in hematology, particularly in the U.S. and European markets, through ongoing success with Brukinsa[3] - The company is focused on expanding its oncology pipeline and expects to achieve revenue growth in new and existing markets, particularly in the U.S.[28] - The company is actively engaged in strategic collaborations to accelerate the development of its drug pipeline[27] - The company aims to enhance drug accessibility and affordability for cancer patients worldwide through innovative drug development[27] Financial Position - Cash and cash equivalents decreased to $3,185,984 thousand by the end of Q4 2023, down from $3,875,037 thousand at the beginning of the year, with net cash used in operating activities of $1,157,453 thousand for the year[13] - The company’s cash, cash equivalents, restricted cash, and short-term investments totaled $3,188.6 million as of December 31, 2023, down from $4,540.3 million in 2022[23] - The company’s total assets decreased to $5,805.3 million as of December 31, 2023, from $6,379.3 million in 2022[23] Employee and Operational Growth - The company has over 10,000 employees globally, with major offices in Beijing, Cambridge, and Basel[27] - The company’s flagship biopharmaceutical manufacturing facility in New Jersey is expected to commence operations in July 2024, with an investment of $800 million and over 1 million square feet of developable space[21]

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today reinforced its continued global expansion, rapid global and U.S. revenue growth, and innovative R&D strategy with the presentation of results from the fourth quarter and full year 2023 and business highlights. “BeiGene made great progress in the fourth quarter and full year 2023 toward our goal to become an impactful next-generation oncology innovator. ...

智通财经APP讯，百济神州(06160)发布公告，欧洲药品管理局(EMA)人用药品委员会(CHMP)发布其推 荐替雷利珠单抗获得上市许可的积极意见，建议批准其用于治疗三项非小细胞肺癌(NSCLC)适应症： 联合紫杉醇和卡铂或注射用紫杉醇(白蛋白结合型)和卡铂用于不可手术切除或不适合含铂放化疗的局部 晚期或转移性鳞状非小细胞肺癌成人患者的一线治疗; 联合培美曲塞和铂类化疗用于PD-L1表达≥50%且无表皮生长因数受体(EGFR) 和间变性淋巴瘤激酶 (ALK)阳性突变、不可手术切除或不适合含铂放化疗的局部晚期或转移性非鳞状非小细胞肺癌成人患者 的一线治疗; 单药用于治疗既往接受含铂药物治疗后的局部晚期或转移性NSCLC成人患者。EGFR突变阳性或ALK突 变阳性的NSCLC患者在接受替雷利珠单抗治疗前应当已接受过靶向治疗。 百济神州实体肿瘤首席医学官Mark Lanasa医学博士表示：“在全球范围内，包括欧盟地区，共入组近 1500例患者的三项3期临床试验中，替雷利珠单抗显示出能够有效治疗初治和难治NSCLC患者。CHMP 今天发布的积极意见让我们有机会更快为欧洲肺癌患者提供一项重要的治疗选择。肺癌是欧洲地区最 ...

A股代码：688235 A股简称：百济神州 公告编号：2024-003 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 自愿披露关于百泽安®（替雷利珠单抗注射液）获欧洲 药品管理局人用药品委员会积极意见的公告 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、欧洲药品管理局（EMA）人用药品委员会（CHMP）近日发布 其推荐百济神州有限公司（以下简称"公司"）产品百泽安®（替雷利 珠单抗注射液）获得上市许可的积极意见，建议批准其用于治疗三项 非小细胞肺癌（NSCLC）适应症：联合紫杉醇和卡铂或注射用紫杉醇 （白蛋白结合型）和卡铂用于不可手术切除或不适合含铂放化疗的局 部晚期或转移性鳞状非小细胞肺癌成人患者的一线治疗；联合培美曲 塞和铂类化疗用于 PD-L1表达≥50%且无表皮生长因子受体（EGFR）和 间变性淋巴瘤激酶（ALK）阳性突变、不可手术切除或不适合含铂放 化疗的局部晚期或转移性非鳞状非小细胞肺癌成人患者的一线治疗； 以及单药用于治疗既往接受含铂药物治疗后的局部晚 ...

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications: In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatm ...

Investment Rating - The report maintains a "Buy" rating for the company with a target price of $275, HKD 165, and RMB 175 [1][3]. Core Insights - The company is actively advancing its internationalization process, with expectations of total revenue of approximately $660 million in Q4 2023. The second overseas product, Tislelizumab (PD-1), is anticipated to receive approval in the U.S. in the first half of the year [1]. - The report highlights that the impact of anti-corruption measures on hospital sales is gradually diminishing, which is expected to lead to a sequential increase in product sales revenue in Q4 2023 [1]. - The company forecasts revenues of $2.486 billion, $3.014 billion, and $3.671 billion for 2023, 2024, and 2025, respectively, representing a CAGR of 37% from 2023 to 2025 [1][4]. Financial Projections - Revenue for 2023 is projected at $2.486 billion, with a year-on-year growth of 75.6%. The net loss for the same year is expected to be $771 million [2][4]. - The report provides detailed financial metrics, including a gross profit margin of 84.2% for 2023 and a projected operating loss of $1.089 billion [4][26]. - The company’s cash and cash equivalents are expected to decrease from $3.557 billion in 2023 to $2.836 billion in 2024 [27]. Market Performance - The current stock price is $153.8, with a potential upside of 79% to the target price of $275 [3]. - The report notes a market capitalization of approximately $16.6 billion [3]. Upcoming Catalysts - Key upcoming catalysts include the expected approval of Tislelizumab for esophageal squamous cell carcinoma (ESCC) in the U.S. and the expansion of indications for other products [1]. - Other anticipated developments include the launch of Zebrutinib in the U.S. and data readouts for various clinical trials [1].

Exhibit 99.1 BeiGene Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates • Continued rapid global growth with record total revenues of $634 million in fourth quarter and $2.5 billion in full-year 2023, increases of 67% and 74% from the prior-year periods • Strengthened leadership in hematology with global BRUKINSA® (zanubrutinib) sales of $413 million and $1.3 billion for the quarter and full year, increases of 135% and 129% • Progressed innovative hematology pipeline with initi ...