Financial Performance - BeiGene reported a significant increase in revenue, reaching $1.2 billion for the fiscal year 2022, representing a 30% year-over-year growth[7]. - The company reported a 40% increase in clinical trial enrollment, indicating strong interest in its investigational therapies[8]. - The company anticipates significant revenue growth in 2023 and beyond, expecting product revenue growth to exceed operating expense growth[18]. - Cumulative losses reached $7.1 billion as of December 31, 2022, primarily due to R&D expenses and operational costs[122]. - The company incurred net cash outflows of $1.5 billion, $1.3 billion, and $1.3 billion for the years ending December 31, 2022, 2021, and 2020, respectively, driven by net losses of $2 billion, $1.5 billion, and $1.6 billion[123]. - The company anticipates continued net losses in the foreseeable future as it expands drug development and seeks regulatory approvals[122]. Product Development and Pipeline - The company is investing $200 million in R&D for new drug candidates, focusing on oncology and immunology[8]. - The company has developed a robust pipeline of innovative therapies, including BCL-2 inhibitors and targeted therapies, with ongoing research on multiple early-stage products[16]. - The company has multiple clinical candidates in various stages, including 5 in Phase 3 trials and 5 designed as registrational Phase 2 trials for its drug 百悅澤® (Zebutinib) targeting B-cell malignancies[43]. - The company is conducting extensive global pivotal clinical projects for 百悅澤®, which has shown superior progression-free survival compared to ibrutinib[42]. - The company has established partnerships for the commercialization of its products in various markets, enhancing its market presence[20]. Market Expansion and Strategy - BeiGene aims to expand its market presence in Europe and Asia, with a target of increasing market share by 15% in these regions by 2024[7]. - The company plans to launch three new products in the next 18 months, targeting a market potential of $2 billion[8]. - The company has established advanced biopharmaceutical and small molecule drug production bases in China and is building a commercial-stage biopharmaceutical production and clinical R&D center in New Jersey, USA[11]. - The company has a global commercialization strategy for its oncology products, focusing on expanding market access in key regions[21]. Collaborations and Partnerships - The company has partnerships with leading biopharmaceutical companies like Amgen and Novartis for the development and commercialization of innovative drugs[11]. - The collaboration agreement with Amgen allows BeiGene to share up to $1.25 billion in development costs for global development of oncology pipeline products[68]. - The company has established a collaboration agreement with Novartis that includes an upfront payment of $650 million and potential milestone payments up to $1.3 billion based on regulatory achievements[71]. - The company has entered into strategic partnerships that may require non-recurring expenses and could dilute existing shareholders' equity[143]. Regulatory and Compliance Challenges - The company acknowledges the impact of COVID-19 on its clinical development, regulatory, commercial, production, and other operations[10]. - The company is subject to various healthcare fraud and abuse laws, which could lead to criminal sanctions and civil penalties[103]. - The company faces significant risks related to regulatory approvals and compliance, which may adversely impact its business operations[101]. - The company must comply with various regulatory requirements in different countries, which may lead to delays or inability to launch products in those markets[106]. Intellectual Property and Competition - The company relies on intellectual property protection for its drugs and candidates, and failure to maintain patents could lead to increased competition[128]. - The company faces significant competition from well-capitalized pharmaceutical companies that invest heavily in R&D and business development to enhance their product pipelines[85]. - The company’s products, including Baiyueze®, Baizean®, and Baihuize®, are expected to face competition from generics and other therapies[89]. - The company acknowledges the presence of numerous third-party patents, which increases the risk of infringement claims as the biotechnology and pharmaceutical sectors expand[133]. Manufacturing and Supply Chain - The company is constructing a biopharmaceutical production and clinical R&D center in New Jersey and a new small molecule production facility in Suzhou, China, while still depending on external suppliers[140]. - The company relies on third-party manufacturers for several commercial and clinical supply drugs, which poses risks if these suppliers fail to deliver adequate quantities or quality[140]. - The company has a commercial supply agreement with Catalent Pharma Solutions for the production of its drug in Kansas City, Missouri, for clinical and commercial supply in the US and other countries[65]. - Supply chain disruptions, including material shortages or natural disasters, could impact the company's contract manufacturers and suppliers[141]. Employee and Management Considerations - The company has over 9,000 employees, reflecting a 15% increase from approximately 8,000 at the beginning of the year[151]. - Retaining key management personnel is critical for the company's success, as their departure could hinder research, development, and commercialization goals[152]. - The competition for qualified personnel in the pharmaceutical and biotechnology sectors is intense, making it challenging to recruit and retain essential staff[153]. - The company plans to expand its management and operational staff significantly across the U.S., China, Europe, and other regions to support its growth strategy[151]. Financial Risks and Funding - The company may need to secure additional financing to fund operations and drug development, with potential reliance on public or private offerings, debt financing, or partnerships[123]. - The company faces risks related to potential dilution of shareholder equity if additional capital is raised through equity issuance or convertible bonds[125]. - The company is exposed to foreign exchange risks due to operations in currencies other than USD, particularly RMB, EUR, and AUD, which may negatively impact financial performance[126]. - The company anticipates continued growth in research, development, production, and commercialization capabilities, which may lead to management challenges[151].

A 股代码：688235 A 股简称：百济神州 公告编号：2023-008 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 2022 年度业绩说明会的公告 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。 重要内容提示： 本次投资者说明会以网络互动形式召开，公司将针对 2022 年度 的经营成果及财务指标的具体情况与投资者进行互动交流和沟通，在 信息披露允许的范围内就投资者普遍关注的问题进行回答。 二、 说明会召开的时间、地点 （一） 会议召开时间：2023 年 4 月 26 日上午 09:00-10:00 （二） 会议召开地点：上海证券交易所上证路演中心（网址： http://roadshow.sseinfo.com/） （三） 会议召开方式：上证路演中心网络互动 1、会议召开时间：2023 年 4 月 26 日（星期三）上午 09:00-10:00 2、会议召开地点：上海证券交易所上证路演中心（网址： http://roadshow.sseinfo.com/） 3、会议召开方式： ...

Financial Performance - Total revenue for the year ended December 31, 2022, increased by approximately $239.6 million or 20.4% to about $1.415 billion, with product revenue rising by approximately $620.6 million or 97.9% to about $1.255 billion[1]. - Total expenses for the year ended December 31, 2022, increased by approximately $590.6 million or 22.6% to about $3.206 billion[1]. - Net loss for the year ended December 31, 2022, increased by approximately $546.0 million or 37.5% to about $2.004 billion[1]. - Basic and diluted loss per share for the year ended December 31, 2022, was $1.49, an increase of 23.1% from $1.21 for the year ended December 31, 2021[1]. - The comprehensive loss for the year ended December 31, 2022, was approximately $2.099 billion, compared to $1.447 billion for the previous year[5]. - The net loss for the year ended December 31, 2022, was $2,003,815 thousand, compared to a net loss of $1,457,816 thousand in 2021, representing an increase in losses of approximately 37.4%[6]. - Total revenue for the year ended December 31, 2022, was approximately $184.8 million, an increase from $140.0 million in 2021, representing a growth of 32.0%[163]. - The company reported a net loss of approximately $2 billion for the year ended December 31, 2022, compared to a net loss of $1.5 billion in 2021, indicating a worsening of 33.3%[165]. Cash and Liquidity - Cash and cash equivalents as of December 31, 2022, were approximately $3.870 billion, down from $4.376 billion as of December 31, 2021[2]. - The total cash and cash equivalents at the end of 2022 were $3,869,564 thousand, down from $4,375,678 thousand at the end of 2021, showing a decrease of approximately 11.6%[7]. - Cash used in operating activities for the year was $1,496,619 thousand, an increase from $1,298,723 thousand in the previous year, indicating a worsening cash flow situation[6]. - The company expects its existing cash, cash equivalents, and short-term investments to meet operational and capital expenditure needs for at least the next 12 months[165]. - Cash, cash equivalents, restricted cash, and short-term investments totaled approximately $1.7 billion in USD and approximately RMB 19 billion (equivalent to about $2.8 billion) as of December 31, 2022[159]. Assets and Liabilities - Total assets as of December 31, 2022, were approximately $6.379 billion, a decrease from $8.536 billion as of December 31, 2021[3]. - Total liabilities as of December 31, 2022, were approximately $1.996 billion, down from $2.403 billion as of December 31, 2021[3]. - The company’s total shareholders' equity as of December 31, 2022, was $4,383,355 thousand, down from $6,132,563 thousand in 2021, reflecting a decline of approximately 28.6%[8]. - The total debt as of December 31, 2022, was $538.1 million, a decrease from $629.7 million in 2021, representing a reduction of 14.5%[165]. - The company has a total debt responsibility of $329 million due within the next twelve months and long-term debt totaling $209 million[178]. Research and Development - Research and development expenses for the year ended December 31, 2022, were approximately $1.641 billion, an increase from $1.459 billion in 2021[4]. - R&D expenses for the year ended December 31, 2022, were approximately $1,640,508,000, compared to $1,459,239,000 in 2021, indicating a rise of 12.4%[87]. - Internal R&D expenses rose by $220.9 million (or 28.2%) to $1 billion, driven by hiring more R&D personnel and increased material costs for clinical candidates[154]. - The company anticipates continued significant investment in R&D to support clinical trials for various cancer treatments and potential key trials[140]. Collaboration and Revenue - The company recognized total collaboration revenue of $161,309 thousand for the year ended December 31, 2022, compared to $542,296 thousand for 2021[26]. - The collaboration agreement with Novartis includes a $650 million upfront payment and potential milestone payments totaling up to $1.55 billion[28]. - The company received a cash upfront payment of $650 million from Novartis in January 2021 as part of a collaboration agreement, and an additional $300 million in January 2022 for expanded collaboration[167]. - Collaboration revenue totaled $161.309 million, a decrease of 70.3% from $542.296 million in the previous year, primarily due to the recognition of significant upfront licensing revenue in 2021[145]. Employee and Compensation - Employee benefits expenses for the year ended December 31, 2022, totaled $83,860,000 for China and $10,298,000 for the 401(k) plan in the U.S.[104]. - Total employee compensation costs for the year ended December 31, 2022, amounted to $1.4 billion, compared to $1 billion in 2021[191]. - The total equity incentive costs recognized for the year ended December 31, 2022, amounted to $303,162,000, compared to $240,712,000 in 2021[100]. Corporate Governance - The company has adhered to the corporate governance code and maintains high standards of internal controls and transparency[194]. - The audit committee is composed of two independent non-executive directors and one non-executive director, ensuring compliance with financial reporting and internal controls[195]. - The company will continue to review and monitor its corporate governance practices to ensure compliance with applicable regulations[196]. Market Presence and Expansion - The company operates in 29 countries and regions, employing over 9,000 staff since its establishment in 2010[10]. - The company is expanding its internal production capacity in China and establishing a commercial-stage biopharmaceutical production and clinical R&D center in New Jersey, USA[9]. - The company has received multiple approvals for its drugs in various markets, including the FDA and MHRA, enhancing its market presence[130]. - The company has established commercialization capabilities in the Asia-Pacific region and is expanding into Latin America and other emerging markets[133]. Future Outlook - The company expects significant revenue growth in 2023 and beyond, with product revenue growth anticipated to exceed operating expense growth[133]. - The company aims to provide impactful and affordable drugs globally, leveraging its integrated biopharmaceutical model and extensive research capabilities[131].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37686 BEIGENE, LTD. (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1209416 (State or other jurisdiction of ...

Company Overview - BeiGene has over 9,000 colleagues across approximately 40 offices on 5 continents[7] - The company has over 950 oncology research team members[8] - BeiGene has a global commercial team of over 3,500 people[7] - The company has 16 approved products[7] - BeiGene's annual product revenue is over $1 billion, with a 109% product revenue growth[7] - The company's cash balance is over $5 billion[7] Clinical Development and Portfolio - BeiGene has approximately 50 assets in clinical and commercial stages[8] - The company has over 60 pre-clinical programs, with the majority having first-in-class potential[8] - BeiGene has conducted over 15 global phase 3 registration trials[14] - The company has initiated over 110 clinical trials with over 20,000 subjects enrolled[14] - BeiGene expects 10+ INDs (Investigational New Drug applications) per year starting in 2024[11] BRUKINSA (Zanubrutinib) - BRUKINSA demonstrated superior efficacy versus ibrutinib in R/R CLL (Relapsed/Refractory Chronic Lymphocytic Leukemia) in the ALPINE trial, with improved ORR (Overall Response Rate) and PFS (Progression-Free Survival)[17] - In the ALPINE trial, BRUKINSA showed a PFS of 79.5% compared to 67.3% for Ibrutinib[19] - BRUKINSA also demonstrated a favorable safety profile versus ibrutinib, with an improved cardiac profile[17] - Serious cardiac adverse events were reported in 1.9% of patients on BRUKINSA compared to 7.7% on Ibrutinib[46] - BRUKINSA is now approved in over 60 markets[57] Tislelizumab - The global market for PD-1/PD-L1 class drugs is estimated to reach $55 billion by 2026[64] - BeiGene is eligible for $1.5 billion collaboration revenue from Novartis for Tislelizumab in North America, Europe, and Japan[64] Financial Strength - BeiGene had a $5.1 billion cash position as of Q3 2022[65] - The company is eligible for up to $3.6 billion in collaboration revenue[65]

Financial Performance - The company's revenue for Q3 2022 was CNY 265,851.60 million, representing a year-over-year increase of 99.05%[1] - The net profit attributable to shareholders for Q3 2022 was CNY -376,983.20 million, with a year-to-date net profit of CNY -1,043,364.80 million[3] - Total revenue for the first three quarters of 2022 reached RMB 6,868,770 thousand, an increase of 10.3% compared to RMB 6,226,519 thousand in the same period of 2021[20] - The net loss attributable to shareholders for the first three quarters of 2022 was RMB 10,433,648 thousand, compared to a net loss of RMB 5,500,355 thousand in the same period of 2021[21] - Operating profit for the first three quarters of 2022 was a loss of RMB 10,348,833 thousand, worsening from a loss of RMB 5,315,735 thousand in the same period of 2021[20] Research and Development - Research and development (R&D) expenses totaled CNY 300,163.40 million in Q3 2022, an increase of 26.70% compared to the same period last year[3] - R&D expenses accounted for 112.91% of revenue in Q3 2022, a decrease of 64.48 percentage points from the previous year[3] - Research and development expenses increased to RMB 8,017,379 thousand in the first three quarters of 2022, up from RMB 6,520,497 thousand in the same period of 2021, reflecting a growth of 22.9%[20] Cash Flow and Liquidity - The net cash flow from operating activities for the year-to-date period was CNY -645,889.50 million, indicating increased cash outflow due to expanded operations[3] - Operating cash inflow for the first three quarters of 2022 was CNY 10,716,565 thousand, up from CNY 7,421,627 thousand in the same period of 2021, representing an increase of approximately 44.5%[22] - Net cash flow from operating activities for the first three quarters of 2022 was -CNY 6,458,895 thousand, compared to -CNY 5,175,561 thousand in the same period of 2021, indicating a decline in performance[22] - The ending balance of cash and cash equivalents as of the end of the reporting period was CNY 27,193,265 thousand, compared to CNY 8,554,254 thousand at the end of the same period last year, reflecting a substantial increase[23] - The company received CNY 9,260,253 thousand in cash from sales of goods and services, an increase from CNY 7,192,627 thousand in the previous year, representing a growth of approximately 28.8%[22] Assets and Liabilities - The total assets at the end of Q3 2022 were CNY 4,783,119.50 million, down 13.33% from the end of the previous year[3] - The equity attributable to shareholders decreased to CNY 3,314,278.20 million, a decline of 16.99% compared to the previous year[3] - Total current liabilities decreased slightly to RMB 10,076,745 thousand from RMB 10,204,479 thousand as of December 31, 2021[18] - The company's total equity attributable to shareholders decreased to RMB 33,142,782 thousand from RMB 39,925,772 thousand as of December 31, 2021, a decline of approximately 16.8%[19] - The total liabilities decreased to RMB 14,688,413 thousand from RMB 15,258,939 thousand as of December 31, 2021, indicating a reduction of approximately 3.7%[18] Shareholder Information - The company has issued a total of 1,349,640,180 shares, with 91.48% of shares being issued overseas[10] - Total number of common stock shareholders at the end of the reporting period was 59,692[11] - Amgen Inc. held 246,269,426 shares, representing 18.25% of total shares[12] - Baker Brothers Life Sciences, L.P. and its affiliates held 152,487,561 shares, accounting for 11.30%[12] - HHLR Fund, L.P. and its affiliates owned 147,035,258 shares, which is 10.89% of total shares[12] - Capital Research and Management Company and its affiliates held 106,958,925 shares, representing 7.92%[12] - The company has 59,683 registered common stock shareholders, including 59,531 in RMB shares[13] Risks and Uncertainties - The company emphasizes the high risks and uncertainties in the biopharmaceutical industry, affecting drug development and commercialization[14] - The company is dependent on third parties for drug development and production, which may impact its operations[14] - Future business plans and actual performance may significantly differ from the company's expectations due to various uncertainties[14] - The company has limited experience in obtaining regulatory approvals and commercializing drugs, which poses additional risks[14] Financial Expenses - The company reported a significant increase in financial expenses, which rose to RMB 1,540,939 thousand in the first three quarters of 2022, compared to RMB 127,038 thousand in the same period of 2021[20]