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]

| --- | --- | |-------|-------------------------------------------------------------| | | | | | ___________________________________________________________ | | | FORM 10-Q | UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition pe ...

Risks and Uncertainties - BeiGene reported significant risks and uncertainties in its forward-looking statements, which may lead to substantial differences in actual performance compared to expectations[5]. - The company highlighted limited experience in launching and marketing internally developed and licensed drugs, which could hinder the generation of substantial product sales revenue[6]. - BeiGene faces intense competition that may allow others to develop or commercialize competitive drugs before it does[6]. - The company relies heavily on the success of its clinical development for drugs and candidates, with potential severe impacts on business if clinical development is unsuccessful or delayed[6]. - BeiGene's production capacity is limited, and it depends on third-party manufacturers, which poses risks if those manufacturers fail to meet their obligations[6]. - The company faces risks related to intellectual property protection, which could allow third parties to compete if not adequately maintained[8]. - The company has outlined a range of risks and uncertainties associated with the development of its drug candidates, including regulatory approvals and market acceptance[31]. Financial Performance - The company anticipates continued significant net losses in the foreseeable future and may not achieve profitability[7]. - Total revenue for the six months ended June 30, 2022, decreased by 14.2% to $648.2 million from $755.9 million in the same period of 2021, primarily due to a reduction in collaboration revenue from a $650 million upfront payment from Novartis recognized in the prior year[36]. - Product revenue increased by 131.3% to $566.1 million for the six months ended June 30, 2022, compared to $244.7 million in the same period of 2021, driven by sales growth of Baiyueze® and Baizean® in the US and China[38]. - Total expenses increased by 31.9% to $1.53 billion for the six months ended June 30, 2022, compared to $1.16 billion in the same period of 2021, with R&D expenses rising by 13.5% to $768.1 million[35]. - Operating loss for the six months ended June 30, 2022, was $882.7 million, an increase of 118.1% from a loss of $404.7 million in the same period of 2021[35]. - Net loss for the six months ended June 30, 2022, was $1.01 billion, a 143.0% increase from a net loss of $413.8 million in the same period of 2021[35]. Research and Development - The company has a global clinical development team of over 2,500 employees conducting nearly 80 ongoing or planned clinical trials for over 40 drugs and candidates, with more than 16,000 participants enrolled[15]. - The company has a strong oncology research capability with a team of over 800 scientists and has successfully developed three regulatory-approved drugs: Baiyueze®, Baizean®, and Baihuaze®[20]. - The company plans to continue investing in research and innovation to discover more innovative drugs that are either first-in-class or best-in-class[20]. - The company is developing multiple early-stage drug candidates, including BGB-11417 (Bcl-2 inhibitor) and BGB-23330 (TYK2 inhibitor), with over 50 preclinical projects in progress[20]. - The company has incurred research and development expenses related to clinical trials and regulatory filings, including costs from contract research organizations and clinical trial consultants[28]. Collaborations and Partnerships - The company has established collaborations with leading biopharmaceutical companies such as Amgen and Novartis for the development and commercialization of innovative drugs[14]. - The company expanded its collaboration with Novartis to develop and commercialize the TIGIT inhibitor, Osemitamab, in the Novartis region[26]. - The collaboration with Novartis includes rights to market five approved oncology drugs in designated areas within China[26]. - The company is responsible for the commercialization of Amgen's XGEVA®, Kyprolis®, and Blincyto® in China, with a profit-sharing agreement in place[196]. - The collaboration with Amgen includes a total funding cap of $1,250,000,000 for global development costs, with the company handling clinical development activities in China[197]. Market and Product Development - The company has three self-developed and approved drugs, including Bruton Tyrosine Kinase (BTK) inhibitor, anti-PD-1 antibody, and selective PARP1 and PARP2 inhibitors, which are marketed in multiple regions including the US, China, and Europe[14]. - The company has licensed 13 approved drugs for commercialization in the Chinese market, leveraging its commercialization capabilities[14]. - The company plans to focus on obtaining approvals for its drug portfolio globally, leveraging its commercialization expertise in China[24]. - The company has commercialized its product, Baiyueze®, in the US, with continuous sales growth as it expands into new indications[23]. - Baiyueze® has been approved in over 50 markets, with ongoing efforts to submit additional applications in various regions[23]. Financial Position and Cash Flow - Cash, cash equivalents, restricted cash, and short-term investments totaled approximately $2.1 billion as of June 30, 2022, including about $3.5 billion in RMB[49]. - The company expects its existing cash, cash equivalents, and short-term investments to meet operational and capital expenditure needs for at least 12 months from the report date[55]. - The total debt due within the next twelve months is $380.7 million, with long-term debt totaling $185.2 million[67]. - The company has significant capital investments in its subsidiaries, such as 3,800,000 RMB in BeiGene (Guangzhou) and 7,000,000 RMB in Suzhou, indicating a strong commitment to its operations in China[172]. - The company reported a total equity of $5,302,544 thousand as of June 30, 2022, down from $6,242,987 thousand at the end of 2021, reflecting a decrease of about 15.1%[164]. Shareholder Information - The total number of issued shares as of June 30, 2022, was 1,344,123,362[90]. - Major shareholders include Amgen Inc. with 246,269,426 shares (18.32%) and Baker Bros. Advisors with 152,419,703 shares (11.34%) as of June 30, 2022[96]. - The company has implemented stock options and restricted stock units for its executives, aligning their interests with shareholders[95]. - The overall ownership structure shows a mix of individual and institutional investors, enhancing corporate governance[96]. - The company has a diverse shareholder base with multiple investment firms holding significant percentages of shares[96]. Regulatory and Compliance - Regulatory approval processes in the US, China, and Europe are lengthy and unpredictable, which could severely impact the company's business if approvals are not obtained[7]. - The company is subject to complex and evolving industry regulations regarding personal data collection and transfer, which could lead to operational challenges and increased costs[9]. - The financial reports indicate that the interim financial statements are prepared in accordance with U.S. GAAP, ensuring compliance with regulatory standards[174]. - The company emphasizes that the interim results may not represent the expected performance for the entire fiscal year, indicating a cautious outlook on future earnings[175].