Table of Contents 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, 2021 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 oth ...

Financial Performance & Growth - BeiGene reported $962 million in Q3 year-to-date revenue from product sales and collaborations[7] - The company's product revenue growth showed a +109% year-over-year increase[58] - Specifically, product revenue in North America grew by +111% year-over-year, reaching $192.5 million in Q3 2021 and $437.2 million for the period of 1Q-3Q 2021[58] - BeiGene has a strong cash position of $7.6 billion, including Q3 2021 cash balance, STAR net proceeds, and Novartis TIGIT upfront payment[7, 63] Pipeline & Clinical Development - BeiGene has approximately 50 assets in clinical and commercial stages[7] - The company has initiated over 100 clinical trials across 45 markets[7, 22] - Zanubrutinib demonstrated a 24-month Progression-Free Survival (PFS) rate of 85.5% compared to 69.5% for Bendamustine + Rituximab (BR) in the SEQUOIA Phase 3 study in 1L CLL[40] - In the ALPINE Phase 3 study of Zanubrutinib vs Ibrutinib in R/R CLL/SLL, Zanubrutinib showed an Overall Response Rate (ORR) of 78.3% compared to 62.5% for Ibrutinib (p < 0.001)[45] Collaborations & Commercialization - BeiGene's PD-1 and TIGIT collaborations with Novartis included nearly $1 billion in upfront payments[16] - The company retains rights to PD-1 and TIGIT to drive broad access for 6.6 billion people in its territories[52, 60] - Brukinsa has been approved in 43 markets by 16 regulatory authorities[7, 57] - BeiGene's global commercial team consists of 3,400+ professionals[7, 9, 58]

Financial Performance - BeiGene reported a significant increase in revenue, reaching $1.2 billion for the fiscal year, representing a 30% year-over-year growth[6]. - The company has set a revenue guidance of $1.5 billion for the next fiscal year, indicating a robust growth outlook[6]. - Total revenue increased by 542.2% from $117.7 million for the six months ended June 30, 2020, to $755.9 million for the six months ended June 30, 2021, primarily due to collaboration revenue from Novartis and increased sales of self-developed products[28]. - Product revenue, net, reached $244.7 million for the six months ended June 30, 2021, compared to $117.7 million for the same period in 2020, representing a 107.9% increase[27]. - Collaboration revenue amounted to $511.1 million for the six months ended June 30, 2021, with no collaboration revenue reported in the same period of 2020[27]. - The company reported a total revenue of $865.3 million for the first half of 2021, reflecting a year-over-year increase of 37.4%[102]. Research and Development - The company is investing heavily in R&D, with an allocation of $400 million for new product development and technology advancements in the upcoming fiscal year[6]. - The company plans to continue investing in research and innovation, having established one of China's largest research teams with over 650 employees and more than 10 self-researched molecules in clinical trials[17]. - The company has approximately 50 drugs and candidates in commercial or clinical development stages, including 10 approved drugs and 2 pending approval[9]. - Research and development expenses increased by 14.7% to $676.8 million for the six months ended June 30, 2021, compared to $590.3 million for the same period in 2020[27]. - The company anticipates a significant increase in research and development costs in the foreseeable future as it continues to support clinical trials for various cancer treatments[25]. Clinical Trials and Approvals - The company has a global clinical development team of over 1,700 people managing more than 95 ongoing or planned clinical trials, with over 13,000 patients and healthy subjects enrolled as of August 2021[9]. - The company expects to achieve regulatory approval for at least three new drugs by the end of 2022, enhancing its product portfolio significantly[6]. - Bai Yue Ze® (Zebutinib capsules) received a marketing authorization application acceptance from the Swiss regulatory authority for the treatment of adult patients with Waldenström's macroglobulinemia on August 18, 2021[11]. - Baiyueze® received conditional approval in Canada for treating adult mantle cell lymphoma (MCL) patients who have received at least one prior therapy, marking the second indication approval in 2021[12]. - Kyprolis® received conditional approval from NMPA for treating adult patients with relapsed/refractory multiple myeloma who have received at least two prior therapies, marking its first indication approval in China[13]. Strategic Partnerships and Collaborations - BeiGene's partnership with Amgen is expected to yield additional revenue streams, with projected contributions of $200 million in the next fiscal year[6]. - The company has established a partnership with Novartis Pharma AG for the development and commercialization of Tislelizumab in multiple regions, including the US and EU, with an initial cash payment received[20]. - The company has formed collaborations with leading biopharmaceutical companies like Amgen and Novartis to develop and commercialize innovative drugs globally[141]. Market Expansion and Commercialization - The company has outlined a strategic plan to expand its market presence in Europe and Asia, aiming for a 15% market share in these regions by 2025[6]. - The company is focused on expanding its commercial product portfolio through self-research efforts and licensing opportunities, aiming to attract favorable licensing opportunities[17]. - The commercial team in China has over 2,900 employees, positioning the company as a leading provider of innovative and affordable medicines in the Chinese market[17]. - The company aims to leverage its commercial scale in China and lower development costs to provide affordable innovative drugs in traditionally underserved regions[18]. Financial Position and Cash Flow - Cash and cash equivalents totaled approximately $3,629.1 million, with additional amounts in RMB and other currencies[38]. - The company incurred a net loss of $413.8 million for the six months ended June 30, 2021, compared to a net loss of $701.3 million for the same period in 2020[46]. - Total liabilities increased to $1,917,341 thousand from $1,731,514 thousand, reflecting higher short-term debt and accrued expenses[135]. - The company reported a net increase in cash and cash equivalents of $396,680,000 for the six months ended June 30, 2021, compared to $729,124,000 for the same period in 2020[139]. - The company expects its existing cash and short-term investments to meet operational and capital expenditure needs for at least the next 12 months[46]. Corporate Governance - The company has adhered to the corporate governance code as per the Hong Kong Listing Rules, ensuring high standards of ethics, transparency, and accountability[113]. - The roles of Chairman and CEO are currently held by the same individual, Mr. Ouyang Qiang, which the board believes facilitates effective execution of strategic initiatives[114]. - The Audit Committee is composed of two independent non-executive directors and one non-executive director, ensuring compliance with financial reporting and regulatory requirements[115]. - The company has implemented an insider trading policy that meets or exceeds the standards set by the Hong Kong Listing Rules[116]. Stock Options and Employee Compensation - The company aims to use various equity-based incentives to attract and retain employees, including stock options and performance-based awards[93]. - The total employee compensation cost for the six months ended June 30, 2021, was $445.1 million, compared to $290.3 million for the same period in 2020, reflecting an increase in the workforce from 5,100 to over 6,400 employees[76]. - The company granted restricted stock units equivalent to 11,250 American Depositary Shares to Mr. Ouyang Qiang and 3,000 to Dr. Wang Xiaodong, totaling 255,450 shares granted to various non-executive directors[104]. Risks and Uncertainties - The company emphasizes the importance of not overly relying on forward-looking statements due to inherent risks and uncertainties[8]. - The company is focused on advancing its drug candidates and expects to face numerous risks and uncertainties related to the development and commercialization of its products[25]. - The impact of the COVID-19 pandemic is expected to continue affecting business operations, including sales and clinical trial activities, with ongoing efforts to minimize disruptions[16].

Financial Performance - BeiGene reported a significant increase in revenue, reaching $1.2 billion for the fiscal year, representing a 30% year-over-year growth[7]. - The company reported a net loss of $200 million, which is a 10% improvement compared to the previous fiscal year, indicating progress towards profitability[7]. - The company has set a revenue guidance of $1.5 billion for the next fiscal year, reflecting a projected growth of 25%[8]. - Operating cash outflows were $1.6 billion and $950.6 million for the years ended 2020 and 2019, respectively, due to net losses[145]. - The cumulative deficit reached $3.6 billion as of December 31, 2020, primarily due to R&D expenses and operational costs[142]. Research and Development - The company successfully commercialized its approved drugs, with a focus on expanding into new indications and regions, aiming for regulatory approvals in multiple markets[8]. - BeiGene's R&D expenses increased to $600 million, reflecting a 25% rise as the company advanced its clinical trials and drug development programs[7]. - The company anticipates launching three new drug candidates in the next fiscal year, targeting a market potential of $2 billion[8]. - The company has developed ten clinical applications over the past decade, including two leading commercial drugs: BRUKINSA® and Tislelizumab[10]. - The global clinical development team consists of over 1,600 members managing more than 60 ongoing or planned clinical trials, with over 12,000 patients enrolled[10]. Product Pipeline and Approvals - The company has a pipeline of over 45 products in commercial or clinical development, including 7 approved drugs and 5 pending approval[10]. - BRUKINSA® (zanubrutinib) received accelerated approval in the US for treating adult patients with previously treated MCL in November 2019 and conditional approval in China for MCL and CLL/SLL in June 2020[15]. - The company has submitted a new indication application for BRUKINSA® to treat relapsed or refractory WM in China, which is under priority review[15]. - The approval status of various products includes multiple approvals in China for indications such as bone-related events and acute lymphoblastic leukemia, with global rights for some products[14]. - The company is actively pursuing additional approvals in the EU, Australia, and Canada for BRUKINSA® for various indications[15]. Market Expansion and Collaborations - The company is exploring strategic partnerships to enhance its market presence and accelerate drug development timelines[8]. - BeiGene is actively pursuing acquisitions to expand its pipeline and enhance its competitive position in the oncology market[8]. - The collaboration agreement with Novartis for the development and commercialization of Tislelizumab includes an upfront payment of $650 million and potential milestone payments up to $1.3 billion, plus royalties on future sales[18]. - BeiGene's partnership with Amgen is expected to enhance its oncology portfolio and expand its market presence in China[90]. - The collaboration agreement allows BeiGene to commercialize products in China for a period of seven years after regulatory approval, with a potential five-year extension for royalty payments[91]. Manufacturing and Supply Chain - The company has established advanced biomanufacturing facilities in China to support future product demand[10]. - The company has commercial supply agreements with multiple third-party manufacturers, including Boehringer Ingelheim and Catalent Pharma Solutions[167]. - The company is constructing a biopharmaceutical production facility in China to enhance its manufacturing capabilities[166]. - The company anticipates that reliance on a limited number of third-party manufacturers may expose it to risks related to regulatory approvals and manufacturing capacity[167]. - The company experienced a temporary supply disruption of ABRAXANE® in China due to a suspension by NMPA, impacting revenue generation from this product[171]. Regulatory Challenges - The lengthy and costly regulatory approval process for new drug applications poses significant risks, with no guarantee of approval[109]. - The company is currently facing regulatory challenges, including a suspension of ABRAXANE® sales in China due to compliance issues, which has resulted in a temporary supply disruption[113]. - The approval process from regulatory bodies like FDA and NMPA is lengthy and unpredictable, potentially harming the company's business if approvals are not obtained[127]. - The company must comply with various regulatory requirements regarding safety, efficacy, and quality to sell approved products in specific jurisdictions[127]. - Regulatory changes may require revisions to clinical trial protocols, potentially impacting costs and timelines[128]. Competition and Market Risks - The company faces intense competition in drug development and commercialization from major pharmaceutical and biotechnology companies, which may impact its market opportunities[108]. - The company is facing competition from generics for Revlimid® (Lenalidomide) and other products, which may significantly impact potential sales[100]. - The company’s ability to maintain market acceptance may be challenged by the introduction of more favorable new products or technologies by competitors[104]. - The potential for mergers and acquisitions in the pharmaceutical industry may concentrate resources among fewer competitors, increasing competitive pressures[109]. - The company may face challenges in demonstrating the safety and efficacy of its drug candidates, which could hinder the approval process[127]. Financial and Operational Risks - The company has limited experience in obtaining regulatory approvals and commercializing drugs, which may affect future performance predictions[144]. - The company may need to seek additional financing through public or private sales, debt financing, or other arrangements to support ongoing operations[146]. - The company is exposed to foreign exchange risks due to expenses and revenues in currencies other than USD or HKD, particularly RMB, EUR, and AUD[149]. - The company faces significant risks in obtaining additional funding on acceptable terms, which could delay or cancel R&D plans or commercialization processes[147]. - The company has incurred significant net losses since its inception and expects to continue generating net losses for the foreseeable future, with profitability not guaranteed[141]. Intellectual Property and Legal Risks - The company relies on maintaining intellectual property rights to protect its drugs and candidates, which is a costly and time-consuming process[152]. - The company faces significant risks related to potential litigation over intellectual property rights, which could be costly and time-consuming[157]. - The company’s ability to exclude others from commercializing similar products may be compromised due to the potential expiration of patents before or shortly after the commercialization of new drug candidates[155]. - The company may struggle to obtain necessary licenses for drug commercialization in various jurisdictions, which could adversely affect its business[160]. - The company may face challenges in patent applications due to existing technologies or defects in applications, which could allow competitors to develop similar drugs[152].

| --- | --- | --- | |-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-------------------------------------------| | Title of each class | Securities registered pursuant to Section 12(b) of the Act: \nTrading Symbol(s) | Name of each exchange on which registered | | American Depositary Shares, each representing 13 Ordinary Shares, par value $0.0001 per share | BGNE | The NASDAQ Gl ...