Financial Performance - Total revenues for Q1 2025 increased by 48.6% to $1.117 billion compared to $751.7 million in Q1 2024[94] - BRUKINSA global sales rose by 62.1% to $791.7 million, with U.S. sales growing by 60.2% to $563.2 million[95] - TEVIMBRA revenue increased by 17.8% to $171.2 million in Q1 2025 compared to $145.3 million in the prior-year period[96] - The company achieved GAAP profitability in Q1 2025, marking a significant turnaround from a net loss of $251.2 million in Q1 2024[92] - GAAP net income improved to $1.3 million in Q1 2025, compared to a loss of $251.2 million in the prior-year period[107] - Adjusted earnings per share (basic) for Q1 2025 was $0.10, compared to a loss of $0.11 in Q1 2024[108] Expenses and Costs - Operating expenses rose by 6.0% to $941.2 million, with R&D expenses increasing by 4.6% to $481.9 million[93] - Selling, general and administrative expenses increased by $31.9 million, or 7.5%, to $459.3 million for Q1 2025, primarily due to global commercial expansion efforts[103] - Selling, general and administrative expenses as a percentage of product sales decreased to 41.4% in Q1 2025 from 57.2% in the prior-year period[103] - Research and development expense increased by $21.2 million, or 4.6%, to $481.9 million for Q1 2025 from $460.6 million in Q1 2024[98] - External research and development expenses rose by $19.4 million, or 11.3%, to $190.8 million in Q1 2025, driven by advancing preclinical and early clinical programs[100] Cash and Debt Management - Cash, cash equivalents, and restricted cash totaled $2.53 billion as of March 31, 2025, down from $2.64 billion at the end of 2024[110] - Total debt decreased to $923.6 million as of March 31, 2025, from $1.02 billion at the end of 2024, with $97.1 million paid down in Q1 2025[110] - The company expects to repay approximately $763.5 million of loans in the next 12 months, with refinancing dependent on prevailing interest rates and credit spreads[116] - As of March 31, 2025, total debt obligations due in the next twelve months are $763.5 million, with long-term debt obligations at $160.2 million[123] - The company had $461.6 million in cash remaining related to the STAR Offering proceeds as of March 31, 2025[111] Revenue Sources - Collaboration revenue increased by 84.8% to $8.7 million in Q1 2025, driven by agreements with Novartis and Amgen[96] Operational Highlights - Gross margin on global product sales improved to 85.1% in Q1 2025, up from 83.3% in the same period last year[97] - Cash provided by operating activities improved by $352.7 million in Q1 2025 compared to Q1 2024, driven by significantly improved revenue and a $325.6 million increase in gross margin[113] - Net cash used in investing activities decreased to $121.9 million in Q1 2025 from $209.8 million in Q1 2024, primarily due to reduced capital expenditures[114] - Financing activities used $33.8 million in cash in Q1 2025, a significant decrease from $162.3 million provided in Q1 2024, mainly due to a net reduction in short-term debt borrowings[115] Strategic Initiatives - The company plans to host an Investor R&D Day on June 26, 2025, to discuss advancements in its late-stage pipelines[92] - The company secured shareholder approval to rename itself to BeOne Medicines Ltd. and to redomicile to Switzerland[92] Legal and Regulatory Developments - The U.S. Patent and Trademark Office invalidated all claims of Pharmacyclics LLC's U.S. Patent No. 11,672,803, benefiting the company's competitive position[89] Foreign Exchange Impact - The RMB appreciated approximately 0.6% against the U.S. dollar in Q1 2025, while it depreciated approximately 2.8% in the year ended December 31, 2024[132] - A hypothetical 10% appreciation in the U.S. dollar against the RMB would have resulted in an increase in foreign exchange loss of approximately $14.8 million as of March 31, 2025[133]

Financial Performance - Total revenue for Q1 2025 reached $1.12 billion, a 49% increase from $751.65 million in Q1 2024[8] - Product revenue for Q1 2025 was $1.11 billion, up 48% from $746.92 million in the same period last year[8] - GAAP operating profit for Q1 2025 was $11.1 million, a significant improvement from a loss of $261.35 million in Q1 2024, marking a 104% change[8] - Adjusted operating profit for Q1 2025 was $139.36 million, compared to a loss of $147.34 million in the previous year, representing a 195% increase[8] - The company achieved its first GAAP quarterly profit in Q1 2025, with a GAAP net profit of $1.27 million, compared to a loss of $251.15 million in Q1 2024[8] - The company reported a net profit of $0.00 per share in Q1 2025, an improvement from a loss of $0.19 per share in the same period last year[14] - The net profit for Q1 2025 was $1,270,000, a turnaround from a net loss of $251,150,000 in Q1 2024[32] Sales and Market Performance - Global sales of Brukinsa (Zebutinib) amounted to $792 million, reflecting a 62% year-over-year growth[7] - The U.S. remained the largest market, contributing $563 million in product revenue for Q1 2025, up from $351 million in the same quarter last year[9] - Baiyueze® sales in the U.S. reached $563 million in Q1 2025, a 60% increase year-over-year, primarily due to increased demand in CLL indications[13] - Baiyueze® is now approved in 75 markets globally, with recent expansions in Japan, Europe, and Brazil[17] Expenses and Costs - R&D expenses for Q1 2025 were $481.9 million, a 5% increase from $460.6 million in Q1 2024; adjusted R&D expenses rose 4% to $421.2 million[11] - SG&A expenses in Q1 2025 were $459.3 million, up 7% from $427.4 million in Q1 2024, with SG&A expenses accounting for 41% of product revenue, down from 57% year-over-year[12] - Operating expenses totaled $941,175,000 in Q1 2025, compared to $888,065,000 in Q1 2024, marking an increase of approximately 6%[32] Cash Flow and Assets - Cash and cash equivalents as of March 31, 2025, were $2,530,591,000, a slight decrease from $2,638,747,000 as of December 31, 2024[33] - Total assets amounted to $5,841,526,000 as of March 31, 2025, down from $5,920,910,000 at the end of 2024[33] - Net cash provided by operating activities was $44,082 thousand in Q1 2025, a significant improvement from a net cash used of $308,572 thousand in Q1 2024[34] - Cash used in investing activities was $121,941 thousand in Q1 2025, compared to $209,831 thousand in Q1 2024[34] Future Plans and Developments - The company plans to hold an investor R&D day on June 26, 2025, to discuss advancements in its late-stage hematologic and solid tumor pipeline[7] - The company expects to report proof of concept data in various projects related to antibody-drug conjugates, multispecific antibodies, and targeted protein degradation throughout the year[7] - The company expects to complete mid-term analysis for the Phase 3 MANGROVE trial for MCL treatment in the second half of 2025[23] - The company plans to submit a global accelerated approval application for Sotoclar in R/R MCL following data readout from a Phase 2 trial anticipated in late 2025[26] - Baiyueze® tablet formulation is anticipated to receive FDA and EU approval in the second half of 2025[23] Corporate Changes - The company has received shareholder approval to adopt a new English name, BeOne Medicines Ltd., and relocate its registered office to Switzerland[7] - The company has received shareholder approval to change its name to BeOne Medicines Ltd. and relocate its registered office to Switzerland, expected to be completed later this year[26]

Financial Reporting - BeiGene, Ltd. filed its 2024 Annual Report with the STAR Market of the Shanghai Stock Exchange on April 28, 2025[5]. - The STAR Annual Report includes financial information for the year ended December 31, 2024, prepared in accordance with PRC GAAP[6]. - Financial information prepared under U.S. GAAP is also included, highlighting differences between PRC GAAP and U.S. GAAP[6]. - The financial information in the report is intended to be furnished and not deemed "filed" under the Exchange Act[8]. Key Financial Metrics - The report contains details on gross profit margin ratio and research and development expenses allocated by key products[6]. Public Availability - The STAR Annual Report is publicly available in Chinese on the Shanghai Stock Exchange's website[7]. Strategic Insights - The report does not include any new product launches or market expansion strategies[5][6]. - No specific performance guidance or future outlook was provided in the current report[5][6]. - The report does not mention any mergers or acquisitions during the reporting period[5][6]. Signatory Information - The filing was signed by Chan Lee, Senior Vice President and General Counsel of BeiGene, Ltd.[16].

港股创新药板块盘初下挫，百济神州跌超6%，荣昌生物跌超5%，信达生物、药明生物、君实生物纷纷 下挫。 ...

Group 1 - The core viewpoint of the article highlights the performance of the CSI Hong Kong-Shanghai Biotech Theme Index, which opened high and is currently at 1195.47 points, reflecting a recent decline of 2.95% over the past month but an increase of 13.55% over the last three months and 13.14% year-to-date [1][2] - The index comprises 50 listed companies involved in biopharmaceuticals, pharmaceuticals, and biotech services from the mainland and Hong Kong markets, serving as a benchmark for the overall performance of biotech-themed securities [1][2] - The top ten weighted companies in the index include: Hengrui Medicine (13.31%), BeiGene (10.94%), WuXi AppTec (8.63%), Mindray Medical (7.77%), WuXi Biologics (5.11%), Innovent Biologics (4.73%), CanSino Biologics (3.38%), CSPC Pharmaceutical Group (2.73%), China National Pharmaceutical Group (2.41%), and Shanghai RAAS Blood Products (1.82%) [1][2] Group 2 - The index's holdings are distributed across different market exchanges, with the Hong Kong Stock Exchange accounting for 41.35%, Shanghai Stock Exchange for 36.05%, and Shenzhen Stock Exchange for 22.61% [1][2] - In terms of industry composition, biopharmaceuticals represent 42.86%, chemical drugs 25.82%, pharmaceutical and biotech services 21.73%, and medical devices 9.59% [2] - The index samples are adjusted biannually, with adjustments occurring on the next trading day following the second Friday of June and December each year, ensuring that the weight factors are updated accordingly [2]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Insights - The company achieved significant revenue growth in 2024, with total revenue reaching 27.21 billion yuan, a year-on-year increase of 56.19%. The net profit attributable to shareholders was a loss of 4.98 billion yuan, but the company is expected to turn positive in GAAP operating profit in 2025 [8] - The global sales of the core product, Zebutinib, have rapidly increased, with 2024 global sales reaching 2.6 billion USD, a year-on-year growth of 105%. The company is positioned as a leader in the hematological malignancies sector [8] - The company is advancing its pipeline for solid tumors, with 13 innovative molecules entering clinical development in 2024, focusing on lung cancer, breast cancer, and gastrointestinal tumors [8] Financial Projections - Total revenue projections for the company are as follows: 35.86 billion yuan in 2025, 43.74 billion yuan in 2026, and 53.37 billion yuan in 2027, with respective year-on-year growth rates of 31.75%, 22.00%, and 22.00% [1][9] - The net profit attributable to shareholders is projected to be 403.5 million yuan in 2025, 3.59 billion yuan in 2026, and 6.75 billion yuan in 2027, with significant growth rates of 108.11% and 790.43% in the following years [1][9] - The earnings per share (EPS) is expected to turn positive in 2025 at 0.29 yuan, increasing to 2.56 yuan in 2026 and 4.82 yuan in 2027 [1][9] Market Data - The closing price of the company's stock is 261.18 yuan, with a market capitalization of approximately 365.98 billion yuan [5] - The company has a price-to-book ratio of 14.99 and a total circulating A-share market value of 30.05 billion yuan [5][6]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Insights - The company achieved significant revenue growth in 2024, with total revenue reaching 27.21 billion yuan, a year-on-year increase of 56.19%. The net profit attributable to shareholders was a loss of 4.98 billion yuan, but the company is expected to turn positive in GAAP operating profit in 2025 [8] - The rapid growth in global sales of the drug Zebutinib has contributed to the company's performance, with 2024 global sales reaching 2.6 billion USD, a year-on-year increase of 105% [8] - The company is advancing its pipeline for solid tumors, with 13 innovative molecules entering clinical development in 2024, targeting lung cancer, breast cancer, and gastrointestinal tumors [8] Financial Summary - Total revenue projections for the company are as follows: 35.86 billion yuan in 2025, 43.74 billion yuan in 2026, and 53.37 billion yuan in 2027, with respective year-on-year growth rates of 31.75%, 22.00%, and 22.00% [1] - The net profit attributable to shareholders is projected to be 403.5 million yuan in 2025, 3.59 billion yuan in 2026, and 6.75 billion yuan in 2027, with significant growth rates of 108.11% and 790.43% in the following years [1] - The earnings per share (EPS) is expected to turn positive in 2025 at 0.29 yuan, increasing to 2.56 yuan in 2026 and 4.82 yuan in 2027 [1]

Investment Rating - The report indicates a cautious outlook for the pharmaceutical sector in 2024 and early 2025, with a strong focus on the innovative drug segment as a key investment opportunity [1][5]. Core Insights - The pharmaceutical sector is expected to face continued pressure on overall performance and profit margins due to factors such as healthcare payment environment, industry regulation, and changing consumer conditions in 2024 and Q1 2025 [1][18]. - Despite the challenges, there is optimism for a recovery in the pharmaceutical sector in the second half of 2025, driven by easing pressures from policies and fundamentals, leading to a potential turnaround in performance and stock prices [1][21]. - The innovative drug segment is highlighted as a primary focus for investment, with expectations for significant growth and valuation recovery for leading companies in this space [2][5]. Summary by Sections Pharmaceutical Sector Overview - The innovative drug segment is performing well, with leading companies like BeiGene and Hengrui Medicine showing strong revenue and business development (BD) income growth [2][22]. - The overall pharmaceutical sector is under pressure, with profit margins declining, except for the innovative drug segment which is experiencing independent growth [1][18]. Biopharmaceuticals - The biopharmaceutical sector is facing challenges, but there are opportunities for growth in specific areas such as long-acting interferons and insulin products, which are expected to see a turnaround [2][4]. Retail Pharmacy - The retail pharmacy sector is showing signs of marginal improvement, with expectations for a gradual return to normal growth in 2025 [2][4]. Medical Services and Aesthetic Medicine - The medical services and aesthetic medicine sectors are experiencing a mild recovery, with expectations for sustained performance in 2025 [3][4]. Traditional Chinese Medicine - The traditional Chinese medicine sector is expected to improve gradually throughout the year, following a challenging 2024 [4][12]. Medical Devices - The medical device sector is anticipated to recover gradually, with significant growth expected from overseas market expansion [4][12]. Investment Recommendations - The report emphasizes the importance of focusing on innovative drug opportunities throughout 2025, particularly in companies with strong international capabilities and those involved in business development [5][21].

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5月2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 2 頁 共 7 頁 v 1.3.0 FF305 FF305 B. 贖回/購回股份 (擬註銷但截至期終結存日期尚未註銷) (註5及6) 備註： (1)第一章節/1/A部在計算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時，參照了上市發行人已發行股份數目總額 （包括於香港聯交所及上海證券交易所 科創板上市的普通股份）。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股 ...

于 2025 年 5 月 1 日向美国证券交易委员会提交 编号：333 – 286725 美国证券交易委员会 华盛顿特区 20549 表格 F-6 生效前第 1 份修订 根据 1933 年证券法提交的 由美国存托凭证证明的美国存托股份 注册声明 百济神州有限公司 BeOne Medicines Ltd. （发行人章程中列明的存托证券发行人准确名称） 不适用 （发行人名称的英文） 瑞士 （发行人注册地或组织机构所在的司法管辖区） 花旗银行 CITIBANK, N.A. （存托银行章程中列明的存托银行准确名称） 388 Greenwich Street New York, New York 10013 (877) 248-4237 （存托银行主要办事处地址，包括邮政编码和电话号码，包括区号） Cogency Global Inc. 122 East 42nd Street, 18th Floor New York, New York 10168 (800) 221-0102 （送达代理人的地址，包括邮政编码和电话号码，包括区号） Mitchell S. Bloom 先生 Edwin M. O'Connor 先生 ...