Financial Performance - The company reported a cumulative loss of 50.972 billion yuan as of December 31, 2022, primarily due to high investment in drug research and development [4]. - BeiGene reported a total revenue of RMB 3.2 billion for the fiscal year 2022, representing a 25% increase year-over-year [15]. - The company achieved a net loss of RMB 1.5 billion in 2022, which is a 10% improvement compared to the previous year [15]. - The company's operating revenue for 2022 was RMB 9,566,409 thousand, representing a 26.06% increase compared to RMB 7,588,957 thousand in 2021 [22]. - The net profit attributable to shareholders for 2022 was a loss of RMB 13,642,041 thousand, worsening from a loss of RMB 9,747,673 thousand in 2021 [22]. - The net cash flow from operating activities for 2022 was a negative RMB 7,799,707 thousand, compared to a negative RMB 8,284,748 thousand in 2021 [22]. - The company's total assets decreased by 19.86% to RMB 44,224,173 thousand at the end of 2022, down from RMB 55,184,711 thousand at the end of 2021 [22]. - The basic earnings per share for 2022 was -10.18 yuan, compared to -8.08 yuan in 2021 [23]. - The company reported a cash position of RMB 2 billion at the end of 2022, providing a solid foundation for future investments [15]. - The company has not distributed profits or converted capital reserves into share capital for the 2022 fiscal year [6]. Research and Development - Research and development expenses for the year were 11.152 billion yuan, representing a year-over-year increase of 16.92% [4]. - The company has invested RMB 500 million in research and development for new technologies, particularly in bispecific antibodies and CAR-T therapies [15]. - Research and development expenses accounted for 116.58% of operating revenue in 2022, a decrease of 9.11 percentage points from 125.69% in 2021 [24]. - The total R&D investment for the current year is 11,152,086 thousand yuan, an increase of 16.92% compared to the previous year (9,538,418 thousand yuan) [109]. - The company has established a comprehensive organizational structure covering drug discovery, preclinical research, clinical trials, and commercialization [78]. - The company has advanced 15 self-developed clinical candidates into clinical trials and commercialization stages, supported by a strong clinical research team of over 2,700 employees globally [97]. - The company has a robust pipeline of candidate drugs, with several in various clinical trial phases, including 3 in Phase III for non-small cell lung cancer (NSCLC) and esophageal squamous cell carcinoma (ESCC) [51]. - The company is committed to advancing its research in immune-oncology, as evidenced by its diverse pipeline targeting various cancers [53]. Drug Development and Pipeline - The company is focused on developing innovative and affordable oncology drugs to improve treatment outcomes for patients globally [4]. - BeiGene is advancing its pipeline with 10 new drug applications expected to be submitted in 2023, focusing on oncology and immunology [15]. - The company has established competitive advantages in research, clinical development, commercialization, and production [4]. - The company has a global clinical development and medical affairs team of over 2,700 employees, conducting more than 80 ongoing or planned clinical trials for over 50 drugs and candidates [31]. - The company has received regulatory approvals for its products in over 65 markets globally [35]. - The company has commercialized 13 licensed drugs in the Chinese market [31]. - The company has received conditional approval for 百悦泽® (Zanubrutinib) in China for adult patients with Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL) who have received at least one prior treatment [38]. - The company has initiated or completed 21 potential registrational clinical trials for 百雷利珠单抗 (Tislelizumab), including 13 Phase 3 trials and 4 pivotal Phase 2 trials [60]. Market Expansion and Strategy - The company expects revenue growth of 20% to 25% for the fiscal year 2023, driven by new product launches and market expansion [15]. - The company plans to expand its market presence in Europe and Asia, targeting a 15% increase in market share by the end of 2023 [15]. - The company is exploring strategic partnerships and potential acquisitions to enhance its product portfolio and accelerate growth [15]. - The company aims to establish a reputation as a leading biotech firm globally by continuously providing effective and differentiated drugs in the US, China, Europe, and other international markets [120]. - The company is expanding its commercial capabilities in the Asia-Pacific region and through distributor partnerships in Latin America and other emerging markets [119]. Risks and Challenges - The company continues to face risks of future losses as it expands its drug development pipeline and seeks regulatory approvals [4]. - The company acknowledges various risk factors that may impact its business and financial performance, as detailed in the management discussion section [5]. - The company faces risks related to the inability to achieve and maintain market recognition for its drugs, which could limit sales and profitability [132]. - The company has limited experience in commercializing self-developed and licensed drugs, which may lead to suboptimal commercialization results [133]. - The company faces risks if competitors develop and commercialize safer, more effective drugs, potentially diminishing its market opportunities [135]. - The company’s ability to maintain its core competitiveness is challenged by significant cumulative losses and ongoing R&D investments [130]. - The company may face significant additional costs and delays if its contract manufacturing organizations (CMOs) fail to meet regulatory standards [148]. - The company faces risks related to the loss of key management personnel, which could hinder research, development, and commercialization goals [162]. Regulatory and Compliance - The company must comply with stringent regulatory requirements for clinical trials, and failure to do so could result in unreliable clinical data and additional trials being mandated by regulatory authorities [149]. - The company is subject to strict regulatory oversight in the pharmaceutical industry in China, which may lead to increased compliance costs and potential delays in drug development [173]. - The company faces complex and costly regulatory compliance costs due to differences in regulations across regions [175]. - The company must continuously evaluate compliance with Good Manufacturing Practices (GMP) to avoid sanctions [176]. - The company is currently assessing the potential impacts of the new regulations on its operations and fundraising activities [199]. Collaborations and Partnerships - The company has partnered with leading biopharmaceutical companies like Amgen and Novartis for the development and commercialization of innovative drugs [31]. - The company has signed collaboration agreements with partners like Amgen, Novartis, and Bristol-Myers Squibb, but faces risks in achieving expected financial and operational synergies from these partnerships [151]. - The company has established strong collaborations with major cancer centers in China to develop drug combinations targeting specific cancers [117]. Production and Supply Chain - The company is constructing a new facility in Suzhou for small molecule drug production and a new base in New Jersey for commercial biopharmaceutical production [144]. - The company has established a commercial team of over 3,500 people to drive the application of its drugs in oncology, with leading positions in the BTK inhibitor and PD-1/PDL-1 categories in China [119]. - The company relies on external suppliers for part of its drug production, which poses risks related to production capacity and regulatory compliance [144]. - The company has faced significant risks from third-party manufacturers, including potential production delays and quality control issues, which could impact clinical trials and commercialization [146].

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]