证券研究报告 | 行业周报 gszqdatemark 2025 03 01 年 月 日 医药生物 【周专题&周观点】【总第 386 期】2024 快报高增长公司梳理— —前三季度高增长公司列举 一、当周（2.24-2.28）回顾与周专题： 当周（2.24-2.28）申万医药指数环比-2.72%，跑赢创业板指数，跑输沪深 300 指数。 当周周专题，我们梳理了 2024 快报高增长的医药公司，并列举了前三季度高增长公司， 供投资者寻找 2024 年业绩超预期的潜在标的。 （二）【AI 医疗应用】国际医学、九安医疗、晶泰控股、美年健康、华大智造、华大基 因、金域医学、固生堂、医脉通等。 （三）【两会政策】生育如华特达因；体检如美年健康。 （四）【其他标的】健友股份、福瑞股份、药明康德、浩欧博、哈药股份等。 2、思路二【医药产业逻辑】 2、原因分析：主要系相关标的涨幅较大且海外映射偏弱，从科技主线演绎到两会。我 们认为：（1）AI 医疗此次调整和去年短期行情不太一样，市场慢慢认识到了 AI 之于医 药医疗未来行业演变的意义，但经过一轮演绎后，医疗 AI 会快速去伪存真，第二波应 该会更聚焦，围绕【场景/入口、数据】 ...

目录 美国 证券交易委员会 Washington, D.C. 20549 表格 10-K （选择一项） ☒ 根据 1934 年证券交易法第 13 条或第 15 条(d)节的年度报告 截至 2024 年 12 月 31 日的财政年度 或 ☐ 根据 1934 年证券交易法第 13 条或第 15 条(d)节的过渡报告 百济神州有限公司 （注册人章程载明的确切名称） （注册成立或组建的州或其他司法管辖区） （美国国家税务局雇主身份识别号码） c/o Mourant Governance Services (Cayman) Limited 94 Solaris Avenue, Camana Bay Grand Cayman 开曼群岛 KY1-1108 （主要行政办事处地址，包括邮政编码） +1 (345) 949 4123 过渡期从 至 交易委员会递交编号：001-37686 BEIGENE, LTD. （注册人的电话号码，包括地区编码） 根据本法案第 12（b）条注册的证券： | 各类别名称 | 交易代码 | 各证券交易所名称 | | --- | --- | --- | | 每股美国存托股份相当于 13 股普通股，每 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 BeiGene, Ltd. 百濟神州有限公司 （於開曼群島註冊成立的有限公司） （股份代號：06160） 內幕消息 百濟神州有限公司 截至2024年12月31日止三個月未經審核業績 及截至2024年12月31日止全年經審核業績以及業務進展 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2024年12月31日 止第四季度的未經審核綜合財務業績及截至2024年12月31日止全年的經審核綜 合財務業績以及業務進展。 本公司欣然公佈本公司及其附屬公司截至2024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2024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、主要管線亮點、企業進展和2025年財務指引（「業務 進展 ...

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2月27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 | 是 | | | | 證券代號 (如上市) | 06160 | 說明 | | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | | 庫存股份變動 | | | | | 事 ...

审计委员会由四名成员构成，包括 Shalini Sharp 女士、Olivier Brandicourt 博士、Anthony C. Hooper 先生及 Corazon (Corsee) D. Sanders 博士。Shalini Sharp 女士为审计委员会主席。 特此公告。 A股代码：688235 A股简称：百济神州 公告编号：2025-009 港股代码：06160 港股简称：百济神州 美股代码：ONC 百济神州有限公司 关于董事会审计委员会主席变更的公告 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。 经百济神州有限公司（以下简称"公司"）董事会审议通过，自 2025 年 3 月 1 日起，Shalini Sharp 女士获委任为董事会审计委员会（以下简 称"审计委员会"）主席，Anthony C. Hooper 先生不再担任审计委员会 主席，但将继续担任审计委员会成员。 百济神州有限公司董事会 2025 年 2 月 28 日 1 ...

Financial Performance - In Q4 2024, total global revenue reached $1.1 billion, a 78% year-over-year increase, while total global revenue for the year reached $3.8 billion, a 55% year-over-year increase[9]. - In Q4 2024, product revenue reached $1,118,035, a 77% increase from $630,526 in Q4 2023[40]. - Total revenue for the year 2024 was $3,810,241, compared to $2,458,779 in 2023, reflecting a 55% year-over-year growth[40]. - Adjusted operating profit for Q4 2024 was $78,603, compared to a loss of $267,224 in Q4 2023, marking a 129% improvement; annual adjusted operating profit was $45,356, up from a loss of $752,473 in 2023[10]. - Net loss for Q4 2024 was $(151,881), compared to $(367,553) in Q4 2023, indicating a reduction in losses[40]. - For the full year 2024, GAAP net loss was $0.47 per share for common stock and $6.12 per ADS, an improvement from $0.65 and $8.45 in the previous year[32]. - Operating cash flow in Q4 2024 was $75 million, an increase of $297 million year-over-year, while the full year cash used in operations was $141 million, a decrease of $1 billion compared to the previous year[32]. Product Sales - Sales of Baiyueze® in Q4 2024 amounted to $828 million, a 100% year-over-year increase, with total sales for the year reaching $2.6 billion, a 105% year-over-year increase[9]. - Sales of Baiyueze® in the US for Q4 2024 were $616 million, a 97% year-over-year increase, with annual sales reaching $2 billion, up 106%[12]. - Baiyueze® sales in Europe for Q4 2024 were $113 million, a 148% increase year-over-year, with annual sales of $359 million, up 194%[12]. - Bai Ze An® sales for Q4 2024 were $154 million, a 20% increase year-over-year, with annual sales of $621 million, up 16%[15]. - Baiyueze® has been approved in over 70 markets globally, with more than 180,000 patients treated[11]. Research and Development - Six new molecular entities (NMEs) entered clinical development in Q4 2024, with a total of 13 for the year; multiple innovative solid tumor projects are expected to have data readouts in the first half of 2025[9]. - The company is leveraging its research and development platforms, including multispecific antibodies and antibody-drug conjugates, to accelerate future treatments in breast cancer, lung cancer, and gastrointestinal cancer[9]. - The company has a robust pipeline with over 1,800 patients enrolled in clinical trials for various indications, including R/R CLL and R/R MCL[17]. - The company plans to read out data from a Phase 3 study of Tarlatamab for small cell lung cancer in H1 2025[20]. - The company expects to enter clinical development for BG-60366 in Q4 2024, targeting EGFR mutations with strong efficacy[20]. Operational Expenses - R&D expenses for Q4 2024 were $542 million, a 10% increase from $494 million in Q4 2023, while annual R&D expenses reached $1.95 billion, up 10% from $1.78 billion[28][30]. - SG&A expenses for Q4 2024 were $505 million, a 21% increase from $418 million in Q4 2023, with annual SG&A expenses totaling $1.83 billion, also up 21% from $1.51 billion[28][30]. - Total GAAP operating expenses for 2024 reached $3,784,351, up from $3,286,595 in 2023, representing a 15.1% increase[49]. - Adjusted sales and marketing expenses for 2024 were $1,549,864, compared to $1,284,689 in 2023, reflecting a 20.7% increase[49]. Future Outlook - The company expects full-year 2025 revenue guidance to be between $4.9 billion and $5.3 billion, while reaffirming expectations for positive GAAP operating profit and positive cash flow from operations[9]. - The company anticipates strong growth in 2025, positioning it as a pivotal year for its operations[9]. - The company projects total revenue for 2025 to be between $4.9 billion and $5.3 billion, driven by strong growth from the product 百悦泽® in the U.S. and continued expansion in Europe and other key markets[33]. - GAAP operating expenses for 2025 are expected to be between $4.1 billion and $4.4 billion, with a projected gross margin in the range of 80% to 90%[33]. - The earnings call for Q4 2024 and full year results will be held on February 27, 2025, at 8 AM EST[34]. Corporate Developments - The company plans to utilize its new English name "BeOne" and has activated the new stock code ONC on NASDAQ[9]. - The company will change its NASDAQ ticker from "BGNE" to "ONC" pending shareholder approval[25]. - The company plans to submit a marketing application for Baiyueze® tablet formulation to the FDA and EU in the second half of 2025[16]. - The company has signed a settlement agreement with MSN Pharmaceuticals, allowing them to sell a generic version of Baiyueze® in the US no earlier than June 15, 2037[12]. - The company plans to present key data at the 2024 ASH annual meeting and the 2025 J.P. Morgan Healthcare Conference[25]. Strategic Focus - The company emphasizes its leadership position in the chronic lymphocytic leukemia (CLL) treatment market with Baiyueze®[9]. - The company emphasizes a data-driven strategy to maximize resource utilization and prioritize promising clinical candidates[14]. - 百济神州 is focused on developing innovative oncology drugs and enhancing drug accessibility and affordability globally[35]. - The company plans to utilize various social media platforms for significant disclosures in compliance with U.S. fair disclosure regulations[36]. - Forward-looking statements include expectations for future revenue, operating profit, cash flow, and gross margin, with actual results subject to various risks and uncertainties[37].

百济神州有限公司 自愿披露关于2025年度经营业绩预测的公告 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。 百济神州有限公司（以下简称"公司"）于 2025年 2月 27日发布根据美国 公认会计原则及美国证券交易委员会适用规则编制的截至 2024 年 12 月 31 日止 年度经审计财务业绩并同步发布根据中国企业会计准则编制的 2024 年度未经审 计业绩快报公告。为让投资者更好地了解公司经营业绩情况和未来业绩前景， 公司将 2025 年度经营业绩预测情况公告如下： 一、2025 年度经营业绩预测 综合近年来的业务发展趋势，公司预计的中国企业会计准则下 2025 年全年 的经营业绩如下： 2025 年营业收入预计将介于人民币 352 亿元至 381 亿元之间，收入强劲增 长的预期主要受益于百悦泽®在美国的领先地位以及在欧洲和全球其他重要市场 的持续扩张；同时基于公司产品组合和生产效率的提高，预计 2025 年毛利率将 处于 80%至 90%的中位区间。公司持续支持商业化及研发增长投入，并继续提 升经营杠杆效益，预计 20 ...

Financial Performance - Total revenue for 2024 reached RMB 27.21 billion, a year-on-year increase of 56.2%[6] - Product revenue amounted to RMB 26.99 billion, up 74.1% compared to the previous year[6] - The net profit attributable to the parent company was a loss of RMB 4.98 billion, an improvement from a loss of RMB 6.72 billion in the previous year[6] - The adjusted operating profit reached 528 million yuan, a significant improvement from an adjusted operating loss of 5.176 billion yuan in the previous year, attributed to rapid global revenue growth and effective expense management [23] - The weighted average return on equity improved to -20.20% from -23.86% in the previous year[6] Product Sales and Market Position - Global sales of Baiyueze® reached RMB 18.86 billion, a 106.4% increase year-on-year, with U.S. sales at RMB 13.89 billion, up 107.5%[10] - Baiyueze® maintained a leading market share in the BTK inhibitor market in China, with all approved indications included in the National Medical Insurance Directory[10] - Sales of Baizean® totaled RMB 4.47 billion, a 17.4% increase, driven by new indications included in medical insurance[11] - The company reported a 56.2% increase in revenue, primarily driven by sales growth of Baiyueze® (Zebutinib) and licensed products from Amgen, as well as Bai Ze An® (Tislelizumab) [21] Clinical Development and Trials - The company has advanced 13 new molecular entities into clinical development in 2024[15] - The company has enrolled over 1,800 participants in the global clinical trial for sonrotoclax (BCL2 inhibitor) and plans to submit a potential accelerated approval application for R/R CLL and R/R MCL indications in the second half of 2025 [16] - The company expects to read out data for BGB-43395 (CDK4 inhibitor) and BG-68501 (CDK2 inhibitor) in the first half of 2025, with multiple internal concept validation data expected in the second half of 2025 [17] - The company has initiated a global phase III clinical trial for tarlatamab (AMG757) in the second-line treatment of small cell lung cancer, with data readout expected in the first half of 2025 [18] - The company plans to conduct a phase III clinical trial for BGB-43395 in combination with endocrine therapy for second-line treatment of HR+/HER2- metastatic breast cancer [18] - The company continues to advance its pipeline with over 130 participants enrolled in the dose escalation study for BGB-45035 (IRAK4 CDAC), with a phase II trial planned for 2025 [19] Regulatory and Licensing Activities - The company is pursuing global regulatory approvals for Baiyueze® and Baizean® in multiple markets, including the U.S. and Japan[14] - The company has entered into a global licensing agreement with Shijiazhuang Yiling Pharmaceutical Technology Co., Ltd. for SYH2039 (BG-89894), a novel MAT2A inhibitor [20] - The company has changed its NASDAQ ticker symbol from "BGNE" to "ONC" as part of its rebranding to BeOne Medicines, pending shareholder approval [20] Risks and Challenges - The company warns of potential risks associated with long R&D cycles, high investment, and uncertainties in drug development and regulatory approval processes [25]

Revenue and Market Approval - BRUKINSA generated global revenues of over $10 billion in 2024, projected to exceed $15 billion by 2028[35]. - TEVIMBRA's global revenues for PD-1/PD-L1 antibody medicines reached approximately $45 billion in 2024, with projections of around $50 billion by 2025[42][43]. - BRUKINSA is approved in more than 70 countries and has the broadest label globally among BTK inhibitors[37]. - TEVIMBRA is approved in China for fourteen indications, including treatments for non-small cell lung cancer and gastric cancer[44]. - XGEVA received conditional approval in China for giant cell tumor of bone in May 2019 and for skeletal-related events in November 2020, with marketing beginning in July 2020[51]. - BLINCYTO is approved in 60 countries for acute lymphoblastic leukemia, with commercialization in China starting in August 2021[52]. - KYPROLIS was approved in China for relapsed/refractory multiple myeloma in July 2021, with commercialization commencing in January 2022[53]. - POBEVCY was launched in late 2021 for various cancers and received NMPA approval in November 2021[56][57]. - Baituowei, a goserelin microsphere formulation, was approved in June 2023 for prostate cancer and included in the NRDL in 2023[58]. - As of December 31, 2024, the company has commercialized its products in over 60 markets[59]. Clinical Trials and Development - The company has over 7,100 patients enrolled in the global BRUKINSA clinical development program across more than 35 trials, with BRUKINSA approved in over 70 markets and more than 180,000 patients treated globally[74]. - Five-year follow-up results from the Phase 3 SEQUOIA study showed a 54-month progression-free survival (PFS) rate of 80% for BRUKINSA in treatment-naïve CLL or SLL patients[75]. - The BGB-16673 study demonstrated an overall response rate (ORR) of 94% at the 200mg dose in CLL/SLL patients, with grade ≥3 treatment-emergent adverse events (TEAEs) reported in 57% of patients[88]. - Tislelizumab has enrolled over 14,000 subjects in clinical trials globally, including 4,700+ subjects outside of China, with data suggesting it is generally well-tolerated and exhibits anti-tumor activity[90]. - The company is investigating sonrotoclax in multiple combination studies, including a Phase 3 trial in combination with BRUKINSA for treatment-naïve CLL/SLL[77]. - The Phase 2b study of zanidatamab in advanced or metastatic HER2-amplified biliary tract cancers has been completed, with a BLA under review by China NMPA as of May 2024[100]. - The company has initiated a confirmatory Phase 3 study for BGB-16673 in relapsed/refractory CLL with pivotal intent, planned for early 2025[86]. - Ociperlimab is currently being investigated in a global Phase 3 trial in combination with tislelizumab for non-small cell lung cancer, with over 2,000 patients enrolled[91]. - BGB-45035, an IRAK4-targeted CDAC, is currently in a Phase 1 clinical trial as monotherapy in healthy participants[110]. - The company is advancing several promising candidates, including sonrotoclax and BGB-16673, which are in various stages of clinical trials globally[143]. Regulatory and Compliance - The FDA's drug approval process involves multiple stages, including preclinical studies, clinical trials, and submission of New Drug Applications (NDA) or Biologics License Applications (BLA)[149][150]. - The FDA may grant priority review designation to a medicine that would provide significant improvement in safety or effectiveness, aiming for action within six months of filing[163]. - A product may be eligible for accelerated approval if it treats a serious condition and demonstrates a meaningful therapeutic benefit over available therapies[164]. - The FDA requires that all marketing applications for new active ingredients must contain an assessment of safety and effectiveness for pediatric patients unless waived[166]. - The company must comply with the General Data Protection Regulation (GDPR) in the EU, which can impose fines of up to €20 million or 4% of total annual global revenue for non-compliance[201]. - The Drug Administration Law (DAL) in China requires drug manufacturers to comply with current Good Manufacturing Practices (GMP) and imposes penalties for violations, including fines of up to RMB 5 million (approximately $725,000)[208]. - The company is required to establish a quality assurance system and is responsible for all aspects of drug development and distribution under the Marketing Authorization Holder (MAH) system in China[204]. - The NMPA regulates all key stages of pharmaceutical products, including nonclinical studies, clinical trials, and marketing approvals[211]. - The NHSA oversees national medical insurance and drug reimbursement schemes, significantly impacting innovative drug pricing in China[213]. - The NMPA has adopted expedited review programs for drugs that are clinically needed, innovative, or for major diseases, allowing for more frequent communication with reviewers[217]. Collaboration and Partnerships - The company has entered into a collaboration agreement with Amgen, responsible for commercializing Amgen's oncology products in China for a period of five to seven years[123]. - BeiGene will contribute up to $1.25 billion worth of development services and cash over the term of the Amgen collaboration[124]. - Amgen holds approximately 20.5% of BeiGene's outstanding shares, acquired for an aggregate purchase price of $2.78 billion[129]. - Under collaboration with Amgen, BeiGene has the right to commercialize three medicines in China, with key patents expiring between 2025 and 2029[138]. Market Access and Pricing Strategies - The latest NRDL list announced in November 2024 includes Tislelizumab for multiple indications, effective January 1, 2025[64]. - The NRDL price for medicines can be modified at the provincial level, reflecting local market conditions[63]. - The company’s patient assistance programs in the U.S. aim to enhance access to BRUKINSA and TEVIMBRA, providing co-pay assistance and free product for some patients[61]. - The 2022 NRDL introduced a price bidding process for non-exclusive drugs, impacting reimbursement rates[63]. - The volume-based procurement program in China has evolved since its national implementation in 2019, affecting pricing strategies for non-exclusive medicines[66]. - The U.S. government has implemented cost containment programs, including the ACA, which may reduce the profitability of drug products through increased rebates and mandatory discounts[184]. - The Inflation Reduction Act of 2022 reduces the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025[186]. - The HHS regulation removes safe harbor protection for price reductions from pharmaceutical manufacturers under Part D, affecting pricing strategies[190]. - The 340B drug pricing program imposes ceilings on prices that drug manufacturers can charge for medications sold to certain healthcare facilities, with potential expansions in eligibility[191]. - State-level regulations are increasingly controlling pharmaceutical product pricing, which may impact the company's pricing strategies and market access[192]. Intellectual Property and Patent Management - As of February 14, 2025, BeiGene holds 63 issued U.S. patents, 15 issued European patents, 28 issued Japanese patents, and 70 issued Chinese patents, with additional pending applications[134]. - Key patents for BeiGene's medicines and drug candidates are set to expire between 2031 and 2043, with several extending to 2036 due to supplemental protection certificates in Europe[136][141]. - The company may apply for patent term restoration under the Hatch-Waxman Act, which allows for a restoration term of up to five years[172]. - Pediatric exclusivity grants an additional six months of exclusivity for all formulations and indications if a pediatric trial is voluntarily completed[174]. - A reference biologic is granted 12 years of exclusivity from the time of first licensure, with the possibility of shared exclusivity among multiple first interchangeable products[177]. - Orphan drug exclusivity prevents the approval of another sponsor's marketing application for the same drug for the same indication for seven years, unless clinically superior[178]. Competition and Market Dynamics - Competition includes major players like AbbVie, AstraZeneca, and Eli Lilly, with products facing strong competition in regulated markets worldwide[140]. - The long-term success of BeiGene's products depends on demonstrating value to physicians, patients, and payers, necessitating significant investment in sales and marketing[146]. Legal and Ethical Considerations - The company is subject to various federal and state laws targeting fraud and abuse, which may impact sales, marketing, and education programs[193]. - The company is subject to federal civil and criminal false claims laws, which can impose civil fines and penalties for each false claim, plus treble damages, and may exclude the entity from federal healthcare programs[34]. - The company may utilize patient assistance programs and co-pay coupon programs to help patients afford approved products, but these programs are under increased scrutiny from government enforcement agencies[198]. - The company must report annually to the Centers for Medicare & Medicaid Services information related to payments made to healthcare practitioners under the Physician Payments Sunshine Act[34]. - The company is subject to scrutiny under federal price reporting laws, which require accurate and timely reporting of complex pricing metrics to government programs[34]. - The company may face civil penalties for violations of state laws that require pharmaceutical companies to disclose marketing and price information to the state[197]. - The company faces potential litigation risks due to state privacy laws that grant consumers rights to access and delete personal information, which may complicate compliance efforts[196]. - The company must monitor the implementation of the DAL and its impact on operations in China due to evolving regulations[209].

Financial Performance - Fourth quarter 2024 net product revenues reached $1.1 billion, a 77% increase from $630 million in Q4 2023; full year revenues totaled $3.8 billion, up 73% from $2.2 billion in 2023[4] - Global BRUKINSA revenues for Q4 2024 were $828 million, a 100% increase year-over-year; full year revenues were $2.6 billion, reflecting a 105% growth compared to 2023[6] - Total revenue for Q4 2024 was $1.1 billion, a 78% increase from $634 million in Q4 2023; full year total revenue was $3.8 billion, up 55% from $2.5 billion in 2023[4] - BRUKINSA sales in the U.S. totaled $616 million in Q4 2024, a 97% increase year-over-year; full year sales were $2.0 billion, reflecting a 106% growth[10] - Tislelizumab sales reached $154 million in Q4 2024, a 20% increase from the prior year; full year sales were $621 million, up 16% compared to 2023[11] - Product revenue reached $1.1 billion for Q4 2024 and $3.8 billion for the full year, up from $631 million and $2.2 billion in the prior-year periods, driven primarily by increased sales of BRUKINSA[27] Operational Efficiency - GAAP loss from operations narrowed to $79.4 million in Q4 2024, a 79% improvement from a loss of $383.8 million in Q4 2023; full year GAAP loss was $568.2 million, down 53% from $1.2 billion in 2023[4] - Adjusted income from operations for Q4 2024 was $78.6 million, a 129% increase from a loss of $267.2 million in Q4 2023; full year adjusted income was $45.4 million, a 106% improvement from a loss of $752.5 million in 2023[4] - Net loss per share improved to $0.11 for Q4 2024 from $0.27 in the prior-year period, with a full-year net loss per share of $0.47 compared to $0.65[31] - Adjusted income from operations for the full year 2024 was $45,356, compared to a loss of $(752,473) in 2023, indicating improved operational efficiency[48] Future Guidance - Full year 2025 revenue guidance is projected between $4.9 billion and $5.3 billion, with anticipated positive GAAP operating income and cash flow generation[6] - Full year 2025 revenue guidance is set between $4.9 billion and $5.3 billion, reflecting strong growth expectations for BRUKINSA[34] - GAAP operating expenses for FY 2025 are projected to be between $4.1 billion and $4.4 billion, with a gross margin percentage expected in the mid-80% range[35] Research and Development - The company advanced six New Molecular Entities (NMEs) into the clinic in Q4 2024, with a total of 13 NMEs advanced for the full year[6] - Research and development expenses for FY 2024 totaled $1.95 billion, a 10% increase from the prior year, driven by advancing clinical programs[29] - Adjusted research and development expenses for Q4 2024 were $474,874, an increase of 8.5% from $437,383 in Q4 2023[48] Cash Flow and Assets - Cash provided by operations for Q4 2024 was $75 million, an increase of $297 million year-over-year, while cash used in operations for the full year decreased by $1.0 billion[32] - Total assets as of December 31, 2024, were $5.92 billion, with total liabilities of $2.59 billion and total equity of $3.33 billion[44] - Cash, cash equivalents, and restricted cash at the end of Q4 2024 were $2,638,747, down from $3,185,984 in Q4 2023, representing a decrease of 17.1%[46] - Net cash provided by operating activities in Q4 2024 was $75,160, compared to a net cash used of $(221,638) in Q4 2023, indicating a significant turnaround[46] - The company reported a net decrease in cash, cash equivalents, and restricted cash of $(74,681) in Q4 2024, contrasting with an increase of $105,092 in Q4 2023[46] Operating Expenses - Total operating expenses for Q4 2024 were $1.05 billion, a 15% increase from $912 million in Q4 2023, with R&D expenses rising by 10% and SG&A expenses increasing by 21%[29] - GAAP cost of sales for products in Q4 2024 was $160,560, up 51.8% from $105,832 in Q4 2023[48] - Adjusted operating expenses for the full year 2024 were $3,218,232, up 13.1% from $2,843,649 in 2023[48] Corporate Changes - The company plans to change its name to BeOne Medicines Ltd. and has changed its Nasdaq ticker from "BGNE" to "ONC" pending shareholder approval[25] - The company plans to continue investing in the global commercial launch of BRUKINSA, particularly in the U.S. and Europe, with SG&A expenses as a percentage of product sales decreasing significantly[30]