浦银国际证券有限公司胡泽宇,阳景近期对百济神州进行研究并发布了研究报告《2Q25业绩再超预期，全年指引上调》，上调百济神州目标价至 276.0元，给予买入评级。 百济神州(688235) 公司2Q25业绩好于预期，公司轻微上调2025年收入、毛利率及现金流指引。维持"买入"评级，上调美股、港股和A股目标价。 2Q25收入、盈利均超预期：2Q25总收入为13.15亿美元(+41.6%YoY,+17.7%QoQ)，包括产品收入13.02亿美元(+41.4%YoY,+17.5%QoQ)，好于我们 预期和VA(Visible Alpha)一致预期，主要由于泽布替尼海外销售强于预期。GAAP经营利润(OP)为8,789万美元，经调整经营利润为2.75亿美元； GAAP净盈利为9,432万美元，经调整净利润为2.53亿美元，连续两个季度实现GAAP经营利润和净盈利，高于我们之前预期和VA一致预期的盈利 数字，主要由于收入及毛利率强于预期。得益于收入增长、海外收入占比提升以及生产效率提高，产品毛利率进一步提升至87.4%(+2.4ppts YoY,+2.2ppts QoQ)，叠加经营效率的持续提升，2Q25公司经营性现金流 ...

Investment Rating - The report maintains a "Buy" rating for the company and raises the target prices for its US, Hong Kong, and A-shares [1][10]. Core Insights - The company's Q2 2025 performance exceeded expectations, leading to a slight upward revision of its 2025 revenue, gross margin, and cash flow guidance [1][3]. - The strong performance is attributed to better-than-expected overseas sales of Zepzelca, particularly in the US market, which is the largest driver of growth [2][4]. Financial Performance Summary - Q2 2025 total revenue reached $1.315 billion, representing a 41.6% year-over-year increase and a 17.7% quarter-over-quarter increase, with product revenue at $1.302 billion [2]. - The GAAP operating profit was $87.89 million, and the adjusted operating profit was $275 million, both exceeding previous expectations [2]. - The GAAP net profit was $94.32 million, with an adjusted net profit of $253 million, marking two consecutive quarters of positive GAAP operating profit and net profit [2]. - The product gross margin improved to 87.4%, up 2.4 percentage points year-over-year and 2.2 percentage points quarter-over-quarter [2]. Guidance Adjustments - The company slightly raised its 2025 total revenue guidance from $4.9-5.3 billion to $5-5.3 billion, and the GAAP gross margin guidance from the mid-range of 80%+ to the upper mid-range [3]. - The cash flow guidance was adjusted from positive operating cash flow to positive free cash flow, while GAAP operating expenses and operating profit guidance remain unchanged [3]. Sales Performance - Zepzelca's sales in Q2 2025 reached $950 million, a 49% year-over-year increase and a 20% quarter-over-quarter increase, with US sales being the primary growth driver [4]. - US sales of Zepzelca amounted to $684 million, reflecting a 42.7% year-over-year increase and a 21.4% quarter-over-quarter increase [4]. - European sales reached $150 million, up 84.9% year-over-year, while sales in China grew to $83.3 million, a 31% year-over-year increase [4]. Research and Development Outlook - The company has a rich pipeline of catalysts expected in the second half of 2025 and 2026, including multiple NDA submissions and clinical trial initiations for various products [9].

Core Viewpoint - The sales of Zepzelca in the U.S. have surpassed those of Acala and Ibru, establishing it as the leading product in the BTK inhibitor market, prompting the company to raise its annual revenue guidance [1][4][7]. Sales Performance - In Q2, Zepzelca's sales in the U.S. reached $684 million, while Acala and Ibru generated $583 million and $543 million, respectively, marking year-on-year growth of 43%, 5%, and -9% [1]. - Zepzelca's quarterly sales in the U.S. converted to approximately 5 billion RMB, making it a standout among domestic innovative drugs [1]. - For the first half of the year, Zepzelca's global sales totaled 12.527 billion RMB, with U.S. sales accounting for 8.958 billion RMB, reflecting a year-on-year increase of 56.2% and 51.7%, respectively [9][11]. Revenue Guidance Adjustment - The company has adjusted its revenue guidance for the year from a range of 35.2 billion to 38.1 billion RMB to a new range of 35.8 billion to 38.1 billion RMB, increasing the lower limit by 600 million RMB [4][7]. Profitability - The company achieved its first quarterly profit under GAAP in Q1, with a total revenue of 17.518 billion RMB, a 46% year-on-year increase, and a net profit of 450 million RMB [9]. - The company has shown a significant turnaround in profitability, with a notable increase in sales across various markets [9][10]. Market Expansion - Zepzelca has seen substantial growth in Europe, with sales reaching 1.918 billion RMB, a year-on-year increase of 81.4%, driven by market share gains in major European markets [10]. - The company is also focusing on expanding its product portfolio beyond Zepzelca, with ongoing development of new products such as the BCL2 inhibitor [15][18]. Management Changes - A new regional manager, Sean Shan, is set to join the company, which may influence future domestic and international strategies [16]. Cost Management and Profit Margins - The company has raised its expected gross profit margin to a range of 80% to 90%, indicating anticipated growth in product sales and improved cost control measures [18][19].

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: 2025年7月31日 狀態: 新提交 本月底法定/註冊股本總額： USD 231,146.38 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 (根據瑞士法律註冊成立的公司) 呈交日期: 2025年8月6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 (如上市) | 06160 | 說明 | 請見備注 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 2,311,463,847 | USD | 0.0001 | USD | | 231,146.38 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 2,311,463,847 | USD | 0. ...

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 (根據瑞士法律註冊成立的公司) 呈交日期: 2025年8月6日 I. 法定/註冊股本變動 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: 2025年5月31日 狀態: 重新提交 | 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 (如上市) | 06160 | 說明 | 請見備註(1) | | | | | | | | | | 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 | | | 2,311,463,847 | USD | | 0.0001 | USD ...

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 公司名稱: 百濟神州有限公司 (根據瑞士法律註冊成立的公司) 呈交日期: 2025年8月6日 I. 法定/註冊股本變動 截至月份: 2025年6月30日 狀態: 重新提交 | 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 (如上市) | 06160 | 說明 | 請見備注 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 2,311,463,847 | USD | 0.0001 | USD | | 231,146.38 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 2,311,463,847 | USD | 0.0001 | USD | | 231,146.38 | 第 1 頁 共 10 頁 v ...

Core Insights - The company reported total revenue of $1.3 billion for Q2 2025, a 42% increase from $929 million in the same period last year, primarily driven by sales growth of Brukinsa® (Zebutinib) in the US and Europe [1] - Product revenue for Q2 2025 was $1.3 billion, up from $921 million year-over-year, with the increase attributed to Brukinsa® sales [1] - In the US, Brukinsa® sales reached $684 million in Q2 2025, a 43% increase from $479 million in the previous year, supported by strong demand across all indications and moderate net pricing benefits [1] Revenue Breakdown - In Europe, Brukinsa® sales for Q2 2025 were $150 million, an 85% increase, driven by market share gains in major European markets including Germany, Italy, Spain, France, and the UK [1] - Baiyuean® (Tislelizumab) sales for Q2 2025 were $194 million, reflecting a 22% year-over-year growth [2] Regulatory Approvals and Market Expansion - Brukinsa® is now approved in 75 markets globally, with five new markets added or expanded for reimbursement this quarter [2] - Baiyuean® is approved in 47 markets globally, with 20 new markets added for reimbursement, including Japan, Europe, and Australia [2] - Recent approvals include the European Commission's endorsement for Baiyuean® in combination with chemotherapy for various cancer treatments [2] Profitability Metrics - The gross margin under GAAP for global product revenue was 87.4% in Q2 2025, up from 85.0% year-over-year, primarily due to the higher sales proportion of Brukinsa® [3] - Adjusted gross margin for product sales increased to 88.1% in Q2 2025 from 85.4% in the same period last year [3]

Group 1 - The core viewpoint of the news highlights the active trading and significant inflow of funds into the Hang Seng Innovation Drug ETF (159316), which reached a new high in scale and saw a notable increase in trading volume [1][2] - As of August 6, the Hang Seng Innovation Drug ETF (159316) had a total scale of 1.084 billion yuan, marking a record since its inception [1] - The ETF experienced a net inflow of 160 million yuan over the past five trading days, with four days showing positive net inflows [1] Group 2 - BeiGene reported a strong performance for Q2 2025, achieving revenues of 1.32 billion USD, a year-on-year increase of 42%, with product revenue contributing 1.30 billion USD [1] - The company turned a profit with a net income of 90 million USD, compared to a loss of 120 million USD in the same period last year, marking the second consecutive quarter of profitability [1] - Management has raised the full-year revenue guidance to 5.053 billion USD from the previous estimate of 4.953 billion USD, and for the first time, they expect positive operating cash flow for the year [1] Group 3 - The Shanghai Municipal Government issued measures to promote the high-quality development of commercial health insurance, which includes 18 initiatives aimed at supporting the biopharmaceutical industry [1] - Dongwu Securities believes that with policy support, there is potential for a win-win collaboration among medicine, insurance, and pharmaceuticals [1] - The new policies are expected to leverage the advantages of commercial insurance in medical expense settlements, facilitating the smooth progress of medical insurance payment reforms and providing strong financial support for the development of innovative drugs and medical devices [1]

Group 1 - The Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index decreased by 1.69% as of August 7, 2025, with mixed performance among constituent stocks [1] - Huada Zhizao led the gains with an increase of 4.42%, while Yuyuan Pharmaceutical and others experienced declines [1][5] - The market for the Sci-Tech Innovation Medical ETF managed by Harvest saw a turnover of 27.9% and a transaction volume of 65.88 million yuan, indicating active trading [3] Group 2 - As of August 6, 2025, the Sci-Tech Innovation Medical ETF reached a new high in scale at 237 million yuan, ranking first among comparable funds [3] - The ETF saw a net inflow of 2.96 million yuan recently, with a total of 17.65 million yuan accumulated over the last five trading days [3] - The ETF's net value increased by 49.39% over the past year, with the highest monthly return recorded at 23.29% since its inception [3] Group 3 - The top ten weighted stocks in the Sci-Tech Innovation Board Biopharmaceutical Index accounted for 49.14% of the index, with leading stocks including United Imaging Healthcare and BeiGene [3] - Minsheng Securities believes that domestic medical insurance policy support and overseas value recognition will sustain the ongoing trend of Chinese innovative drugs [5] - China has become a core procurement area for global trading, with traditional pharmaceutical companies accelerating their innovation and international expansion [5]

Market Performance - The Hang Seng Hong Kong Stock Connect Innovative Drug Select Index (HSSCPB) decreased by 4.06% as of August 7, 2025 [3] - Notable declines in constituent stocks include: Innovent Biologics (09969) down 9.00%, Lepu Biopharma-B (02157) down 8.21%, and CanSino Biologics (09926) down 7.18% [3] - The Hong Kong Innovative Drug Select ETF (520690) fell by 2.79%, with the latest price at 0.98 yuan [3] - Over the past week, the Hong Kong Innovative Drug Select ETF has seen a cumulative increase of 1.62%, ranking in the top half among comparable funds [3] Liquidity and Trading Activity - The Hong Kong Innovative Drug Select ETF had a turnover rate of 16.49%, with a trading volume of 57.78 million yuan, indicating active market participation [3] - The average daily trading volume for the ETF over the past year was 72.86 million yuan [3] Company Performance - BeiGene reported a total revenue of 17.518 billion yuan for the first half of 2025, a year-on-year increase of 46.0% [3] - The company achieved a net profit of 450 million yuan, marking its first half-year profit since its A-share listing [3] - Revenue growth was driven by sales of self-developed products such as Baiyueze® and licensed products from Amgen, alongside improved operational efficiency through cost management [3] Industry Trends - Despite significant financing pressures in primary and secondary markets, enthusiasm for domestic innovative drug research remains high, with continuous growth in innovative outcomes [4] - In 2024, six domestic innovative drugs received their first approvals overseas, reflecting an acceleration in international recognition [4] - In clinical research, domestic innovative drug trial registrations surpassed those in the U.S. for the first time in 2023, ranking first globally [4] - The share of domestic innovative drugs in emerging therapies is notably high, with significant clinical results from products like Zebutini and AK112 [4] Fund Performance - The Hong Kong Innovative Drug Select ETF saw a significant increase of 28 million shares over the past week, ranking in the top half among comparable funds [4] - The ETF experienced a net outflow of 2.0112 million yuan recently, but had net inflows on three out of the last four trading days, totaling 27.5305 million yuan [4] - The management fee for the ETF is 0.50%, and the custody fee is 0.10%, making it the lowest among comparable funds [4] - As of August 6, 2025, the ETF's tracking error for the year was 0.173%, the highest tracking precision among comparable funds [4] Index Composition - The top ten weighted stocks in the HSSCPB index include BeiGene (06160), Innovent Biologics (01801), WuXi Biologics (02269), and others, collectively accounting for 78.31% of the index [5] - The index aims to reflect the performance of Hong Kong-listed companies involved in innovative drug research, development, and production [5]