2025 中期報告 BeOne Medicines Ltd. （根據瑞士法律註冊成立的公司） Cancer has no borders. Neither do we. 目錄 | 公司資料 | 2 | | --- | --- | | 前瞻性陳述 | 4 | | 管理層討論及分析 | 7 | | 其他資料 | 28 | | 未經審核中期簡明綜合經營表 | 82 | | 未經審核中期簡明綜合全面虧損表 | 83 | | 未經審核中期簡明綜合資產負債表 | 84 | | 未經審核中期簡明綜合股東權益報表 | 86 | | 未經審核中期簡明綜合現金流量表 | 87 | | 未經審核中期簡明綜合財務報表附註 | 89 | | 釋義 | 124 | | 技術詞彙 | 128 | 1 百濟神州有限公司 • 2025 中期報告 公司資料 董事會 執行董事 歐雷強先生 （主席兼首席執行官） 非執行董事 王曉東博士 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 A ...

BeOne Medicines Ltd. 百濟神州有限公司 (a corporation incorporated under the laws of Switzerland) （根據瑞士法律註冊成立的公司） (Stock Code 股份代號: 06160) Dear non-registered shareholder(s), September 26, 2025 Reminder Letter regarding the Arrangement of Electronic Dissemination of Corporate Communications With reference to the notification letter dated February 28, 2024 titled "Arrangement of Electronic Dissemination of Corporate Communications", BeOne Medicines Ltd. (the "Company") is writing to remind you that the Company has ad ...

BeOne Medicines Ltd. 百濟神州有限公司 (Stock Code 股份代號: 06160) September 26, 2025 Dear registered shareholder(s), Reminder Letter regarding the Arrangement of Electronic Dissemination of Corporate Communications With reference to the notification letter dated February 28, 2024 titled "Arrangement of Electronic Dissemination of Corporate Communications", BeOne Medicines Ltd. (the "Company") is writing to remind you that the Company has adopted electronic dissemination of corporate communications (the "Corporate Comm ...

Drug Development and Commercialization - BeOne Medicines Ltd. reported significant advancements in drug commercialization and regulatory approvals, indicating a strong pipeline for future growth[9]. - The company is focused on expanding its sales and marketing capabilities, aiming to launch and commercialize new drugs upon approval[10]. - BeOne Medicines Ltd. is actively developing both small molecule drugs and large molecule biologics to meet global demand, enhancing its production and clinical research facilities[10]. - The company emphasizes the importance of maintaining and expanding regulatory approvals for its drugs and candidates[9]. - BeOne Medicines Ltd. is assessing the potential market size for its drugs and candidates, indicating a strategic focus on market access and acceptance rates[10]. - The company is focused on the successful completion of clinical trials and obtaining regulatory approvals for its candidate drugs[10]. - The company maintains a leading position in the BTK inhibitor market with Baiyueze® across five approved indications in the U.S.[16]. - The European Medicines Agency granted priority medicine designation for BGB-16673, a BTK degrader, for patients previously treated with BTK inhibitors[17]. - The company received positive opinions from the CHMP recommending the approval of Baiyueze® for preoperative and postoperative treatment in high-risk resectable non-small cell lung cancer patients[19]. - The company has launched a new generation BCL2 inhibitor, Sotokura, showing positive results in clinical trials for adult patients with mantle cell lymphoma[17]. - The company anticipates over 20 research milestones within the next 18 months, including advancements in solid tumor pipelines targeting various high-incidence cancers[16]. Financial Performance - Total revenue increased by 44.7% from $1.680 billion for the six months ended June 30, 2024, to $2.433 billion for the six months ended June 30, 2025[28]. - Product revenue net increased by 44.5% to $2.411 billion for the six months ended June 30, 2025, compared to $1.668 billion for the same period last year[29]. - Sales of Baiyueze® reached $1.741 billion, a 54.7% increase from $1.126 billion year-over-year[29]. - Baiyueze® global sales totaled $1.741 billion, with U.S. sales at $1.247 billion, reflecting a 50.1% increase from $830 million[30]. - Baiyueze® sales in Europe reached $266 million, a 79.7% increase, driven by market share growth across major European markets[30]. - The company achieved GAAP profitability for the first time in both Q1 and Q2 of 2025, with positive free cash flow in Q2[25]. - Net profit for the six months ended June 30, 2025, was $95.6 million, compared to a net loss of $371.6 million in the same period last year[27]. - Adjusted net profit for the six months ended June 30, 2025, was $389.0 million, compared to a loss of $122.6 million in the same period of 2024[46]. Research and Development - The company has a dedicated oncology research team of over 1,200 scientists, ensuring continuous innovation and market leadership[22]. - The company has invested in various technology platforms, including CDAC protein degraders and bispecific antibodies, to enhance its research and innovation capabilities[22]. - R&D expenses rose by 10.0% to $1.007 billion, while total operating expenses increased by 12.2% to $2.004 billion[27]. - External R&D expenses increased by $70.132 million (21.2%) to $400.259 million, driven by higher costs associated with advancing clinical projects[36]. Cash Flow and Liquidity - Cash and cash equivalents were approximately $2.8 billion as of June 30, 2025[25]. - Operating cash flow provided $307,680 thousand, a significant increase of $711,800 thousand compared to the same period last year, driven by substantial revenue growth and a gross profit increase of $359,700 thousand[64]. - The company plans to utilize existing cash to meet significant cash needs, including operational, capital, and production expenditures[69]. - Cash used in investing activities was $188,546 thousand, a decrease from $320,863 thousand in the previous year, primarily due to reduced capital expenditures[65]. Debt and Equity - Total debt decreased by 6.2% from $1.018 billion as of December 31, 2024, to $954.5 million as of June 30, 2025[60]. - The company's debt-to-equity ratio decreased from 30.6% as of December 31, 2024, to 25.3% as of June 30, 2025, primarily due to a reduction in debt and an increase in shareholder equity[87]. - The company has $615.4 million in outstanding floating-rate debt as of June 30, 2025, with a potential increase of approximately $6.2 million in annual pre-tax interest expense for every 100 basis points rise in interest rates[80]. Corporate Governance - The company is committed to maintaining high standards of corporate governance and has adhered to the applicable corporate governance code principles[179]. - The audit committee consists of four independent non-executive directors, with Shalini Sharp serving as the chair, ensuring compliance with financial reporting and internal controls[181]. - The remuneration committee is composed of three independent non-executive directors, with Margaret Han Dugan as the chair, responsible for reviewing and recommending executive compensation[182]. - The nomination and corporate governance committee is currently led by Anthony C. Hooper, ensuring compliance with the Hong Kong listing rules regarding board composition[183]. Shareholder Information - The total number of issued shares as of June 30, 2025, is 1,539,858,562 shares[106]. - Amgen Inc. holds 246,269,426 shares, representing 15.99% of the total shares[101]. - The company has issued 21,880,885 shares under equity awards, which are currently considered circulating shares[97]. - The company has a stock option plan that allows for the issuance of shares to employees, with 133,000,000 shares held by a subsidiary for this purpose[106]. Employee Stock Options and Incentives - The company plans to continue expanding its stock option program to incentivize employee performance and retention[156]. - The exercise price for options granted under the revised 2016 plan must not be lower than the higher of the fair market value at the time of grant or the average closing price over the previous five trading days[133]. - The total number of unexercised stock options as of the report date is 64,383,926[155]. - The stock options granted are subject to a vesting schedule, with 25% vesting on the first anniversary and the remaining 75% vesting monthly over 36 months[152].

Industry Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The innovative drug sector is experiencing a positive trend with significant revenue growth and a reduction in losses, indicating a potential for sector-wide profitability [2][6] - The overall revenue for the innovative drug sector in H1 2025 reached 30.649 billion yuan, a year-on-year increase of 9.77%, while the net loss attributable to shareholders was 2.096 billion yuan, showing a substantial reduction in losses [6] - The sector's gross margin remains high at 84.43%, with a slight decrease compared to the previous year, but showing signs of recovery in Q2 2025 [3][6] Summary by Sections Innovative Drug Sector - The innovative drug sector's revenue for H1 2025 was 30.649 billion yuan, with a growth rate of 9.77% year-on-year. Q2 2025 revenue was 16.387 billion yuan, reflecting a 33.24% increase [5][6] - The sector's gross margin for H1 2025 was 84.43%, slightly down from the previous year, but Q2 2025 saw an increase to 84.73% [3][6] - The number of License-out transactions with upfront payments exceeding 10 million USD reached a new high, indicating that overseas rights have become a crucial funding source for Chinese companies [4][7] Financial Performance - The innovative drug sector's net loss for H1 2025 was 2.096 billion yuan, with a significant reduction in losses of 127.58% year-on-year. The adjusted net loss was 2.880 billion yuan, reflecting a 151.25% reduction in losses [5][6] - The sector's operating cash flow was positive at 210 million yuan, indicating improved financial health [5] Traditional Pharmaceutical Sector - The traditional pharmaceutical sector, comprising 136 listed companies, reported total revenue of 254.895 billion yuan in H1 2025, a decrease of 1.64% year-on-year. The net profit attributable to shareholders was 32.099 billion yuan, down 4.83% [26][32] - The gross margin for the traditional pharmaceutical sector was 51.05% in H1 2025, showing a slight increase compared to the previous year [27][32] - The sector is adapting to policy changes, with increased industry concentration and some leading companies achieving growth through transformation and international expansion [32]

Group 1 - The pharmaceutical sector in both A-shares and Hong Kong stocks experienced a collective decline on September 26 [1] - In A-shares, Sunflower dropped by 10%, while Guangsheng Tang and Aosaikang fell over 8%. Other companies like Jimin Health, Hanyu Pharmaceutical, Wanbangde, Hengrui Medicine, and Huiyu Pharmaceutical also saw declines [1] - In Hong Kong stocks, WuXi AppTec decreased by over 5%, BeiGene fell by more than 4%, and Fosun Pharma dropped nearly 2% [1]

Core Insights - On September 25, BeiGene's stock rose by 1.93%, with a trading volume of 1.609 billion yuan, indicating positive market sentiment towards the company [1] - The company reported a significant increase in revenue and net profit for the first half of 2025, showcasing strong financial performance [2] Financing and Margin Trading - On September 25, BeiGene had a financing buy-in amount of 190 million yuan, with a net buy of 8.8079 million yuan, indicating robust investor interest [1] - The total margin trading balance for BeiGene reached 1.244 billion yuan, with a financing balance of 1.225 billion yuan, accounting for 3.37% of its market capitalization, which is above the 90th percentile of the past year [1] - The company also experienced high levels of short selling, with a short selling balance of 18.8487 million yuan, also exceeding the 90th percentile of the past year [1] Shareholder Structure - As of June 30, 2025, BeiGene had 23,300 shareholders, a decrease of 3.90% from the previous period, while the average number of circulating shares per person increased by 4.11% to 4,976 shares [2] - The top ten circulating shareholders included notable institutional investors, with changes in holdings reflecting varying levels of confidence in the company [2]

Summary of Key Points from Conference Call Records Industry Overview - The conference call discusses the **Chinese innovative drug industry** and its current trends, particularly focusing on the **CRO (Contract Research Organization)** and **CDMO (Contract Development and Manufacturing Organization)** sectors [1][3][13]. Core Insights and Arguments - **Valuation Trends**: The valuation of Chinese innovative drugs is currently lower than historical peaks, with a static PS (Price to Sales) ratio around 7 times, compared to a high of 9.3 times. However, due to global competitiveness, the theoretical static PS is expected to exceed previous levels, driven by significant product cycles [2][4]. - **BD Activity**: There has been a surge in business development (BD) transactions among domestic innovative drug companies, with upfront payments in the first nine months of the year reaching **6.58 billion yuan**, surpassing the total of **6 billion yuan** for the entire previous year. The total transaction amount also exceeded **56.4 billion yuan** compared to **48.9 billion yuan** last year [4]. - **Immunotherapy and ADC Developments**: Chinese companies are showing strong global competitiveness in the dual-antibody sector, with significant clinical advancements. For instance, **AK12** from Kangfang Biotech has multiple ongoing Phase III trials, and **IBI363** from Innovent has received FDA approval for a global Phase III study in lung cancer [5][6]. - **Weight Loss Sector**: The weight loss sector is highlighted as a competitive area, with promising data from Eli Lilly's oral GLP-1 molecule, **ofgliprant**, providing opportunities for Chinese companies to improve their offerings [8][10]. Additional Important Insights - **CRO and CDMO Recovery**: The CRO industry has moved past its most challenging period, with increased investment activity and a recovery in overseas demand for Chinese CDMO companies. Key players such as WuXi AppTec and Tigermed are recommended for attention [3][13]. - **Upstream Pharmaceutical Chain Recovery**: There are signs of recovery in the upstream pharmaceutical supply chain, particularly in R&D, with companies like **BaiPuSiSi** experiencing a resurgence in market demand [14]. - **Global Competitiveness Strategies**: Chinese innovative drug companies are encouraged to enhance their global competitiveness through overseas sales, R&D, and potential licensing opportunities. Companies like BeiGene and Legend Biotech are highlighted for their performance in this regard [12]. Conclusion The conference call provides a comprehensive overview of the current state and future prospects of the Chinese innovative drug industry, emphasizing the importance of global competitiveness, active BD transactions, and the recovery of the CRO and CDMO sectors. The insights presented indicate a positive outlook for the industry, driven by innovation and strategic partnerships.

Group 1 - US-listed Chinese stocks experienced a pre-market rally, with Alibaba rising by 9% [1] - Baidu saw an increase of 5% in pre-market trading [1] - JD.com gained 3% in the same period [1] Group 2 - Bilibili and NIO both rose by 2% [1] - Pinduoduo and Trip.com increased by 1% [1] - BeiGene saw a modest rise of 0.5% [1]

Core Viewpoint - The A-share market is experiencing a significant rebound, particularly in the Sci-Tech Innovation Board, with the ETF Huatai-PineBridge (589120) showing a notable increase of 1.59% as of 13:54 on September 24, and attracting over 20 million yuan in net subscriptions within three trading days [1][3]. Group 1: ETF Performance - The Huatai-PineBridge Sci-Tech Innovation Drug ETF (589120) has seen strong performance, with most of its constituent stocks rising, including Teva Biopharma up over 3%, and several others like Zai Lab and Eucure Biopharma rising over 2% [3]. - The top ten constituent stocks of the ETF include notable companies such as RYSE Pharmaceuticals (688235) with a weight of 9.92% and a rise of 1.93%, and Eucure Biopharma (688578) with a weight of 8.03% and a rise of 2.27% [4]. Group 2: Market Dynamics - The National Healthcare Security Administration is set to hold a communication meeting in Beijing to discuss negotiations and pricing with companies, marking a significant innovation in this year's healthcare directory adjustments [5]. - The current innovation drug market is driven by the trend of "local innovation - global monetization," which is seen as a key support for the industry's growth [6]. - Analysts from Xinda Securities believe that the trend of innovation in the drug sector is not over, with expectations for continued growth in innovative drugs, medical devices, and AI healthcare [7]. Group 3: Industry Outlook - Tianfeng Securities highlights that the Chinese innovative drug industry has achieved significant results and is now globally competitive, entering a phase of self-sustainability through commercialization [8]. - The industry is supported by favorable policies, a well-structured talent pool, and a collaborative approach between academia and industry, which enhances the efficiency of drug development [9]. - The future outlook suggests that increasing innovation will further unlock commercial value, with China becoming one of the most efficient countries in the drug development process [10].