Financial Performance - Total revenues reached $752 million in Q1 2024, with product revenue of $747 million, marking an 82% increase from the prior year[119] - Gross profit increased to $626.7 million, a 71.2% rise from $366 million in the same quarter last year[126] - Net loss narrowed to $251.2 million, a 27.9% improvement from a loss of $348.4 million in Q1 2023[126] - Net product revenue increased by 82.0% to $746.9 million for the three months ended March 31, 2024, compared to $410.3 million in the prior-year period[130] - Global sales of BRUKINSA totaled $488.5 million in the first quarter, representing a 131.1% increase compared to the prior-year period[131] - U.S. sales of BRUKINSA grew by 153.3% to $351.5 million, while European sales increased by 242.8% to $66.8 million[131] - Sales of tislelizumab in China totaled $145.2 million, reflecting a 26.4% increase from the prior-year period[132] - Gross margin on global product sales increased to $622.0 million, with a gross margin percentage of 83.3% for the three months ended March 31, 2024[135] Expenses and Losses - Operating expenses totaled $888.1 million, up 20.5% from $737.3 million, driven by increased research and development costs[126] - Research and development expenses rose by 12.7% to $460.6 million, driven by higher development milestone fees and internal research activities[136] - Selling, general and administrative expenses increased by 30.1% to $427.4 million, primarily due to investments in commercial activities[139] - The company reported a net loss of $251.2 million for the three months ended March 31, 2024, compared to a net loss of $348.4 million for the same period in 2023, resulting in an accumulated deficit of $8.2 billion as of March 31, 2024[147] Revenue Sources - BRUKINSA generated $489 million in revenue, with growth of 153% in the U.S. and 243% in Europe compared to the prior year[119] - Collaboration revenue decreased by 87.4% to $4.7 million, primarily due to the termination of the Novartis collaborations[127] Regulatory Approvals - The European Commission approved tislelizumab for non-small cell lung cancer across three indications[120] - The FDA approved TEVIMBRA for the treatment of unresectable or metastatic esophageal squamous cell carcinoma, expected to be available in the U.S. in the second half of 2024[120] - BRUKINSA received its fifth indication in B-cell malignancies in the U.S. after FDA granted accelerated approval for relapsed or refractory follicular lymphoma[122] Cash Flow and Debt - Cash and cash equivalents decreased to $2.8 billion as of March 31, 2024, down from $3.5 billion at the end of the previous year, with net cash used in operating activities amounting to $308.6 million in Q1 2024[151] - The company utilized $209.8 million in investing activities during the three months ended March 31, 2024, primarily for capital expenditures of $156.6 million and IPR&D asset purchases of $31.8 million[155] - Financing activities generated $162.3 million in cash during Q1 2024, mainly from $142.0 million in short-term loans and $9.1 million from long-term loans[157] - Total debt increased to $1,025.99 million as of March 31, 2024, up from $885.98 million at the end of 2023[145] - The company has total debt obligations of $1.03 billion, with $827.0 million due within the next 12 months[168] Foreign Currency and Inflation - The impact of foreign currency translation negatively affected cash by $22.4 million in Q1 2024, compared to a positive impact of $11.3 million in the prior-year period[159] - The RMB depreciated approximately 1.7% against the U.S. dollar in the three months ended March 31, 2024, and approximately 2.8% in the year ended December 31, 2023[176] - The company has not used derivative financial instruments to hedge exposure to foreign exchange risk despite holding significant amounts of RMB[175] - Inflation has not had a material effect on the company's results of operations during the three months ended March 31, 2024[179] Future Outlook and Commitments - The company plans to fund its material cash requirements through existing financial resources and anticipated receipts from accounts receivable and product sales[163] - As of March 31, 2024, the company had a remaining co-development funding commitment of $457.0 million related to the Amgen collaboration[170] - The company expects to refinance its debt obligations based on historical experience, with the ability to do so influenced by prevailing interest rates and credit spreads[157] - The company expects to utilize its existing RMB cash deposits in its China operations over the next several years[175] Accounting Policies - The company continues to evaluate its critical accounting policies, with no material changes reported for the three months ended March 31, 2024[173] - The company has not reported any new accounting policies adopted during the three months ended March 31, 2024[173] - The company assesses various factors for estimating the useful lives of long-lived assets and the fair value of financial instruments, which may lead to differences from actual results[172] - The company is exposed to risks related to changes in interest rates and foreign currency exchange rates, which may impact its financial condition[174][176]

[Financial Highlights](index=1&type=section&id=Financial%20Highlights) BeiGene achieved significant revenue growth in Q1 2024, with total revenues reaching $751.7 million, while substantially reducing operational losses and improving efficiency Financial Performance Summary (in millions USD) | Financial Metric | Q1 2024 | Q1 2023 | % Change | | :--- | :--- | :--- | :--- | | Net product revenues | $746.9 | $410.3 | 82% | | Total Revenue | $751.7 | $447.8 | 68% | | GAAP loss from operations | $(261.3) | $(371.3) | (30)% | | Adjusted loss from operations* | $(147.3) | $(275.9) | (47)% | - The company's strong global revenue growth has elevated it into the **top 15 of global oncology innovators** based on total oncology sales[2](index=2&type=chunk) - BeiGene is demonstrating significantly improved operating leverage and is progressing on its path to achieving **sustainable profitability**[1](index=1&type=chunk)[2](index=2&type=chunk) [Key Business & Pipeline Updates](index=1&type=section&id=Key%20Business%20%26%20Pipeline%20Updates) Key products BRUKINSA and TEVIMBRA show strong commercial growth and regulatory approvals, while the pipeline advances rapidly in hematology and solid tumors [BRUKINSA (zanubrutinib)](index=1&type=section&id=BRUKINSA%20%28zanubrutinib%29) BRUKINSA revenue reached $489 million in Q1 2024 with strong U.S. and European growth, securing its fifth FDA approval for R/R follicular lymphoma BRUKINSA Revenue by Region (in millions USD) | Region | Q1 2024 Revenue | YoY Growth | | :--- | :--- | :--- | | **Total** | **$489** | - | | U.S. | $351 | 153% | | Europe | $67 | 243% | - Received U.S. FDA approval for treating adult patients with relapsed or refractory (R/R) follicular lymphoma, establishing BRUKINSA with the **broadest label in the BTKi class**[1](index=1&type=chunk)[5](index=5&type=chunk) - BRUKINSA is gaining market share in treatment-naïve (TN) chronic lymphocytic leukemia (CLL) and has become the **BTKi class leader in new-patient share** for relapsed or refractory (R/R) CLL in the U.S.[4](index=4&type=chunk) [TEVIMBRA (tislelizumab)](index=2&type=section&id=TEVIMBRA%20%28tislelizumab%29) TEVIMBRA sales grew 26% to $145 million in Q1 2024, securing key regulatory approvals in Europe and the U.S. for NSCLC and ESCC - Sales of tislelizumab totaled **$145 million** in Q1 2024, representing **26% growth** compared to the prior-year period[5](index=5&type=chunk) - Key regulatory approvals were secured: - **European Commission:** Approved for three indications in non-small cell lung cancer (NSCLC) - **U.S. FDA:** Approved for second-line esophageal squamous cell carcinoma (ESCC) - **U.S. FDA:** Accepted Biologics License Application (BLA) for first-line gastric or gastroesophageal junction cancers[5](index=5&type=chunk) [Key Pipeline Highlights](index=2&type=section&id=Key%20Pipeline%20Highlights) The pipeline shows strong progress in hematology with sonrotoclax and BGB-16673, and in solid tumors with multiple readouts and new assets entering the clinic in H2 2024 - **Hematology Pipeline:** - **Sonrotoclax (BCL2 inhibitor):** Received FDA fast track designation for R/R mantle cell lymphoma (MCL) and continues enrollment for registrational intent trials - **BGB-16673 (BTK CDAC):** Initiated expansion cohorts with potential registrational intent in R/R MCL and R/R CLL, with a Phase 3 trial in R/R CLL expected by year-end 2024[6](index=6&type=chunk) - **Solid Tumor Pipeline:** - **Lung Cancer:** Completed enrollment in a Phase 3 trial for ociperlimab (anti-TIGIT) and expects readouts for multiple tislelizumab combinations in 2024 - **Breast Cancer:** Progressing dose escalation for CDK4 and CDK2 inhibitors and dosed the first patient in a Phase 1 study for B7H4 ADC - **New Assets:** Pan-KRAS inhibitor, MTA-cooperative PRMT5 inhibitor, EGFR CDAC, CEA-ADC, and FGFR2b-ADC are on track to enter the clinic in H2 2024[6](index=6&type=chunk)[7](index=7&type=chunk)[8](index=8&type=chunk) [Detailed Financial Performance](index=4&type=section&id=Detailed%20Financial%20Performance) Q1 2024 saw an 82% product revenue increase to $747 million and improved gross margin, with operating leverage gains leading to a reduced net loss per share [Revenue and Gross Margin](index=4&type=section&id=Revenue%20and%20Gross%20Margin) Total Q1 2024 revenue reached $752 million, driven by an 82% increase in product revenue to $747 million, with gross margin improving to 83% - Total Q1 2024 revenue was **$752 million**, with product revenue contributing **$747 million**, an **82% increase** from Q1 2023[10](index=10&type=chunk) - The U.S. was the largest market, with product revenue of **$351 million**, a **153% increase** from the prior year period[10](index=10&type=chunk) - Gross margin as a percentage of global product revenue increased to **83%** in Q1 2024 from **80%** in Q1 2023, mainly due to a higher sales mix of global BRUKINSA[11](index=11&type=chunk) [Operating Expenses and Profitability](index=4&type=section&id=Operating%20Expenses%20and%20Profitability) Total GAAP operating expenses rose 20% to $888.1 million, but improved operating leverage led to a 30% reduction in GAAP loss from operations and a reduced net loss per share Operating Expenses (GAAP, in millions USD) | Expense Category | Q1 2024 | Q1 2023 | % Change | | :--- | :--- | :--- | :--- | | Research and development | $460.6 | $408.6 | 13% | | Selling, general and administrative | $427.4 | $328.5 | 30% | | **Total operating expenses** | **$888.1** | **$737.3** | **20%** | - The increase in operating expenses was due to advancing preclinical and early clinical programs (R&D) and continued investment in the global commercial launch of BRUKINSA (SG&A)[12](index=12&type=chunk)[13](index=13&type=chunk) - Profitability metrics improved, with GAAP Net Loss decreasing to **$251.2 million** from **$348.4 million** in Q1 2023. Net loss per share improved to **$(0.19)** from **$(0.26)**[13](index=13&type=chunk)[14](index=14&type=chunk)[19](index=19&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) The condensed consolidated financial statements detail a net loss of $251.2 million for Q1 2024, with total assets of $5.7 billion and total equity of $3.4 billion [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2024, total revenues were $751.7 million, resulting in a gross profit of $626.7 million and a net loss of $251.2 million, or $(0.19) per share Condensed Consolidated Statements of Operations (in thousands USD) | (in thousands of U.S. dollars) | Three Months Ended March 31, 2024 | | :--- | :--- | | Total revenues | $751,652 | | Gross profit | $626,717 | | Loss from operations | $(261,348) | | **Net loss** | **$(251,150)** | | Net loss per share, basic and diluted | $(0.19) | [Condensed Consolidated Balance Sheet](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheet) As of March 31, 2024, BeiGene reported $2.8 billion in cash and equivalents, with total assets of $5.7 billion and total equity of $3.4 billion Condensed Consolidated Balance Sheet (in thousands USD) | (in thousands of U.S. dollars) | As of March 31, 2024 | | :--- | :--- | | Cash, cash equivalents, restricted cash and short-term investments | $2,807,436 | | Total assets | $5,667,681 | | Total liabilities | $2,307,320 | | Total equity | $3,360,361 | [Non-GAAP Financial Measures](index=9&type=section&id=Non-GAAP%20Financial%20Measures) Non-GAAP financial measures provide additional insight into operating performance by excluding non-cash items, with adjusted loss from operations at $147.3 million for Q1 2024 - BeiGene uses non-GAAP financial measures to provide a more complete understanding of its operating performance by excluding non-cash items such as share-based compensation, depreciation, and amortization[22](index=22&type=chunk) Reconciliation of GAAP to Adjusted Loss from Operations (in thousands USD) | Reconciliation of GAAP to Adjusted Loss from Operations (in thousands) | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | GAAP loss from operations | $(261,348) | $(371,258) | | Plus: Share-based compensation expenses | $88,714 | $75,388 | | Plus: Depreciation | $24,110 | $19,025 | | Plus: Amortization of intangibles | $1,183 | $986 | | **Adjusted loss from operations** | **$(147,341)** | **$(275,859)** |

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4月30日 狀態: 新提交 致：香港交易及結算所有限公司 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5月7日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 | 06160 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 9,500,000,000 | USD | | 0.0001 USD | | 950,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 9,500,000,000 | USD | | 0.0001 USD | | 950,000 | | 2. 股份分類 | ...

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5月2日 | | | | | | | | 第一章節 | | --- | --- | --- | --- | --- | --- | --- | --- | | 普通股 | 股份類別 不適用 | | | 於香港聯交所上市(註11) | 是 | | 1. 股份分類 | | 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4月29日 | 1,243,678,450 | | | | | | | | 於股份獎勵計劃下發行股份 | 155,922 | 0.011 % | USD | 0. ...

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4月30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4月28日 | 1,243,439,848 | | | | | | | 1). 於股份獎勵計劃下發行股份 | | | 238,602 | ...

4 2024年通函 及年度股东大会通告 致股东函件 致各位股东 ： 作为新一代全球肿瘤创新公司，百济神州始终引领创新药物的研 发，力求惠及全球更多患者。在此，很高兴能向各位分享公司在 2023年所取得的重大成就。 如今，百济神州比以往任何时候都更具取得成功的势态。我们团 队所取得的成就以及为患者带来的影响，令我倍感振奋。凭借极 具成本优势的全球能力，我们实现了在更短时间内以更低成本研 发出更多潜在开创性的分子，并推动了三款自主研发产品在70个 市场获得监管批准。 展望2024年及未来，我们超过1,100名富有创业精神的科学家团 队将全力推动公司创新研发管线，实现新的突破。在血液学领 域，多款具有影响力的新一代管线产品将互为补充，并进一步 巩固我们在这一领域的领先地位，包括"重磅炸弹"BTK抑制剂 (BTKi)百悦泽®、极具前景的BCL-2抑制剂sonrotoclax，以及潜 在"同类首创"的靶向BTK的嵌合式降解激活化合物(CDAC)BGB- 16673。此外，随着公司自研的抗PD-1抗体百泽安®持续拓展全球 足迹，包括在美国及欧盟获批，同时正在全球多个市场和适应症 领域接受审评，我们已为开拓实体瘤业务做好了 ...

| A 股代码：688235 | A 股简称：百济神州 | 公告编号：2024-014 | | --- | --- | --- | | 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 年年度股东大会的通知 本公司董事会及全体董事保证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： 一、 召开会议的基本情况 （一） 股东大会类型和届次 2024 年年度股东大会 召开日期时间：2024 年 6 月 5 日 21 点 30 分（北京时间） 网络投票系统：上海证券交易所股东大会网络投票系统 网络投票起止时间：自 2024 年 6 月 5 日 股东大会召开日期：2024年6月5日 本次股东大会采用的网络投票系统：上海证券交易所股东大会网络投票 系统 （二） 股东大会召集人：董事会 （三） 投票方式：本次股东大会所采用的表决方式是现场投票、邮寄投票（仅 限非 A 股股东）和网络投票相结合的方式 （四） 现场会议召开的日期、时间和地点 召开地点：Mourant Gover ...

A 股代码：688235 A 股简称：百济神州 公告编号：2024-012 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 董事会决议公告 本公司董事会及全体董事保证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。 一、董事会会议召开情况 具体内容详见公司同日披露于上海证券交易所网站 （www.sse.com.cn）的《百济神州有限公司 2023 年年度报告》 及其摘要。 1 （三）审议通过《科创板募集资金相关事项》 表决结果：11 票赞成，0 票反对，0 票弃权。 百济神州有限公司（以下简称"公司"）董事会于 2024 年 4 月 25 日作出一致书面决议，审议通过全部议案。 二、董事会会议审议情况 （一）审议通过《科创板 2023 年度经审计财务报表》 表决结果：11 票赞成，0 票反对，0 票弃权。 具体内容详见公司同日披露于上海证券交易所网站 （www.sse.com.cn）的《2023 年年度审计报告》。 （二）审议通过《科创板 2023 年年度报告》 表决结果：11 票赞成，0 票反对，0 票弃权。 董事会 ...

百济神州有限公司 2023年度 非经营性资金占用及其他关联资金往来情况的专项说明 2024年4月25日 | 目录 | | --- | | | | | 一、 | 非经营性资金占用及其他关联资金往来情况的专项说明 | 1 - 2 | | --- | --- | --- | | 二、 | 非经营性资金占用及其他关联资金往来情况的说明 | 3 - 6 | 非经营性资金占用及其他关联资金往来情况的专项说明 安永华明（2024）专字第70033281_A03号 百济神州有限公司 百济神州有限公司董事会： 我们审计了百济神州有限公司的2023年度财务报表，包括2023年12月31日的合并 资产负债表，2023年度的合并利润表、合并股东权益变动表和合并现金流量表以及相 关财务报表附注，并于2024年4月25日出具了编号为安永华明（2024）审字第 70033281_A01号的无保留意见审计报告。 按照《上市公司监管指引第8号——上市公司资金往来、对外担保的监管要求》的 要求，百济神州有限公司编制了后附的2023年度非经营性资金占用及其他关联资金往 来情况汇总表（以下简称"汇总表"）。 如实编制和对外披露汇总表，并确保其真实性 ...

百济神州有限公司 2023年度 募集资金存放与实际使用情况的专项报告 2024年4月25日 | | | 页 | 次 | | --- | --- | --- | --- | | 一、 | 募集资金存放与实际使用情况鉴证报告 | 1 - | 2 | | 二、 | 募集资金存放与实际使用情况的专项报告 | 3 – | 10 | 目录 我们按照《中国注册会计师其他鉴证业务准则第3101号——历史财务信息审计或 审阅以外的鉴证业务》的规定执行了鉴证业务。该准则要求我们计划和执行鉴证工作， 以对募集资金专项报告是否不存在重大错报获取合理保证。在鉴证过程中，我们实施 了包括了解、抽查、核对以及我们认为必要的其他程序。我们相信，我们的鉴证工作 为发表意见提供了合理的基础。 我们认为百济神州有限公司的募集资金专项报告在所有重大方面按照《上市公司 监管指引第2号——上市公司募集资金管理和使用的监管要求》、《上海证券交易所科 创板上市公司自律监管指引第1号——规范运作》及相关格式指南编制，如实反映了 2023年度百济神州有限公司募集资金存放与实际使用情况。 本报告仅供百济神州有限公司披露2023年度报告使用，不适用于其他用途。 A ...