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].

Financial Performance - As of June 30, 2022, the company has accumulated losses of CNY 43.994 billion due to high investment in drug research, development, and commercialization[3]. - The company's operating revenue for the first half of 2022 was CNY 421,025.40 million, a decrease of 13.92% compared to CNY 489,094.50 million in the same period last year[19]. - The net profit attributable to shareholders was a loss of CNY 666,381.60 million, worsening from a loss of CNY 249,317.00 million in the previous year[19]. - The net cash flow from operating activities showed a net outflow of CNY 333,733.80 million, increasing from a net outflow of CNY 194,734.90 million year-on-year[19]. - The company's net assets attributable to shareholders decreased by 10.79% to CNY 3,561,858.60 million from CNY 3,992,577.20 million at the end of the previous year[19]. - Collaboration revenue for the first half of 2022 was CNY 534 million, primarily from partial revenue recognition of collaboration prepayments from Novartis[141]. - In the first half of 2022, product revenue reached CNY 3.676 billion, up from CNY 1.583 billion in the same period last year, driven by sales growth of self-developed products Baiyueze® and Baizean®[141]. Research and Development - Research and development expenses for the reporting period amounted to CNY 5.016 billion, representing a year-on-year increase of 20.82%[3]. - Research and development expenses accounted for 119.13% of operating revenue, an increase of 34.25 percentage points compared to 84.88% in the previous year[20]. - The company has advanced preclinical research capabilities with over 50 projects, half of which have the potential to be first-in-class or best-in-class candidates[27]. - The clinical development team consists of over 2,500 employees executing nearly 80 ongoing or planned clinical trials for over 40 drugs and candidates, with more than 30 key or potentially registrable clinical trials[27]. - The company has a robust pipeline with multiple candidates in various clinical trial phases, including treatments for chronic lymphocytic leukemia (CLL) and solid tumors[61]. - The company has over 40 drugs and candidates undergoing nearly 80 clinical trials globally, with more than 16,000 subjects enrolled[129]. - The company has established 13 core technology platforms to support its drug development, with over 10 self-developed clinical candidates advancing to clinical trials and commercialization[109]. Product Development and Commercialization - BeiGene reported a revenue of RMB 1.2 billion for the first half of 2022, representing a year-over-year increase of 30%[15]. - The company achieved a total of 5,000 patients treated with its therapies, marking a 25% increase compared to the previous year[15]. - The company is expanding its market presence in Europe, with plans to launch three new products by the end of 2022[15]. - The company has established a strong commercialization team in China with over 3,100 employees, leveraging its capabilities to commercialize 13 approved drugs in the Chinese market[26]. - The company has received conditional approval for Baiyueze® to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) in Uruguay[34]. - Baiyueze® has been approved in multiple regions, including Kuwait, Bahrain, and Qatar, for treating adult patients with MCL[31]. - The company has a diverse pipeline of products, including those for advanced NSCLC, ovarian cancer, and multiple myeloma, with various regulatory statuses across different markets[40]. Strategic Partnerships and Collaborations - BeiGene's partnership with Amgen is expected to enhance its product pipeline and market reach significantly[15]. - The company has formed collaborations with leading biopharmaceutical companies like Amgen and Novartis to develop and commercialize innovative drugs[26]. - The company has signed strategic cooperation agreements with Amgen, Novartis, and Bristol-Myers Squibb, but faces risks in achieving the expected financial and operational goals from these collaborations[183]. - The collaboration with Novartis was expanded in December 2021, granting Novartis exclusive rights for the development and commercialization of BGB-A1217 in North America, Japan, and several European countries[78]. Regulatory and Compliance - The report includes forward-looking statements that involve known and unknown risks and uncertainties, which may lead to actual performance differing significantly from those projected[6]. - The report is unaudited, and the board of directors guarantees the authenticity, accuracy, and completeness of the financial report[4]. - The company faces risks of significant cumulative losses and potential delisting if it fails to maintain operational viability as per the Shanghai Stock Exchange regulations[150]. - The approval process for new drugs is lengthy and costly, with the company having limited experience in regulatory submissions, increasing inherent risks[160]. - Regulatory approvals from agencies like NMPA, FDA, and EMA are subject to varying requirements, which may delay or prevent market entry in different regions[161]. Market Expansion and Future Outlook - BeiGene anticipates a revenue guidance of RMB 2.5 billion for the full year 2022, reflecting a growth of approximately 20%[15]. - The company plans to explore potential acquisitions to bolster its portfolio and accelerate growth in key therapeutic areas[15]. - The company is actively pursuing market expansion and commercialization of its products in the Greater China region[40]. - The company expects to retain most of its available funds for business development and growth, indicating no plans for cash dividends in the near future[151]. - The company aims to achieve commercialization of new indications and expand its market share in the oncology sector[123]. Challenges and Risks - The company faces risks of continued losses if clinical trials fail, regulatory approvals are not obtained, or market acceptance is not achieved[3]. - The company has faced significant risks associated with relying on limited CMO for clinical and commercial supply, including potential delays and increased costs due to regulatory evaluations and inspections[174]. - The company is dependent on third-party manufacturers (CMOs) for the production of its drugs, which poses risks related to timely delivery and compliance with GMP regulations[172]. - The company has experienced supply interruptions in the past, such as with ABRAXANE®, which could impact the timely delivery of candidate drugs to patients[174]. - The ongoing COVID-19 pandemic has negatively impacted the company's business operations, including commercial sales and clinical trial activities[194]. Human Resources and Management - The company has approximately 8,500 employees as of mid-2022, with expectations for continued growth, necessitating effective management of this expansion[198]. - The company has 3,029 R&D personnel, an increase from 2,477 in the previous year, representing 35.05% of total employees[126]. - The company provides stock options, restricted stock units, and restricted stock to encourage valuable employees to continue serving the company[200]. - Employee turnover, especially among key personnel, may hinder the company's research, development, and commercialization goals[200]. - The company’s key management team plays a critical role in its operations, and their potential departure poses a risk to the company's development[199].

| --- | --- | |-------|-------------------------------------------------------------------------| | | | | | ___________________________________________________________ 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 June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition p ...

Financial Performance - Total revenue for Q1 2022 was RMB 194,785.80 million, a decrease of 50.4% compared to the same period last year[2] - Total revenue for Q1 2022 was 1,947,858 thousand RMB, a decrease of 50.5% compared to 3,928,894 thousand RMB in Q1 2021[20] - Net profit attributable to shareholders was a loss of RMB 286,634.50 million, representing a decline of 965.9% year-over-year[2] - Net loss for Q1 2022 was -2,866,345 thousand RMB, compared to a profit of 331,008 thousand RMB in Q1 2021[22] - The total comprehensive loss for Q1 2022 was -3,063,036 thousand RMB, compared to a gain of 497,630 thousand RMB in Q1 2021[23] Cash Flow and Liquidity - The net cash flow from operating activities was a negative RMB 196,108.60 million, down 347.7% from the previous year[2] - Cash flow from operating activities showed a net outflow of -1,961,086 thousand RMB in Q1 2022, compared to a net inflow of 791,685 thousand RMB in Q1 2021[24] - Cash and cash equivalents at the end of Q1 2022 were 25,544,570 thousand RMB, down from 10,720,968 thousand RMB at the end of Q1 2021[25] - The company reported cash and cash equivalents of 25,153,115 as of March 31, 2022, a decrease from 25,189,667 at the end of 2021[18] Research and Development - R&D investment totaled RMB 251,677.10 million, which is 129.2% of total revenue, an increase of 76.2 percentage points compared to the previous year[3] - Research and development expenses for Q1 2022 were 2,516,771 thousand RMB, an increase of 20.9% from 2,080,683 thousand RMB in Q1 2021[20] Shareholder Information - Basic and diluted earnings per share were both -2.15 RMB, reflecting a significant loss due to decreased collaboration revenue[3][8] - Basic earnings per share for Q1 2022 were -2.15 RMB, compared to 0.28 RMB in Q1 2021[23] - The company reported a total of 1,334,805,269 shares issued, with 91.38% of shares being issued overseas[9] - The largest shareholder, Amgen, holds 246,269,426 shares, representing 18.45% of total shares[12] - Total number of common stock shareholders at the end of the reporting period was 70,047, a slight increase from the previous period[10] Assets and Liabilities - Total assets at the end of the reporting period were RMB 5,094,598.80 million, a decrease of 7.7% from the end of the previous year[3] - Total assets decreased to 50,945,988 from 55,184,711 in the previous year[18] - Total current liabilities decreased to 8,729,555 from 10,204,479 in the previous year[18] - The total liabilities decreased to 13,482,592 thousand RMB in Q1 2022 from 15,258,939 thousand RMB in Q1 2021[19] - The company has a total of 1,279,775 in long-term borrowings as of March 31, 2022, compared to 1,289,780 at the end of 2021[18] Operational Costs - Total operating costs increased to 4,720,140 thousand RMB in Q1 2022, up 33% from 3,547,421 thousand RMB in Q1 2021[20] - The company reported a significant increase in sales expenses, which rose to 1,317,988 thousand RMB in Q1 2022 from 782,050 thousand RMB in Q1 2021, reflecting a 68.3% increase[20] Industry Risks and Focus - The company emphasizes the high risks and long development cycles associated with the biopharmaceutical industry, which may impact future performance[15] - The company is focused on maintaining its intellectual property rights and navigating regulatory approvals for its drug candidates[15]

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company's unaudited statements show a Q1 2022 net loss of $434.3 million and total assets of $8.02 billion Condensed Consolidated Balance Sheet Data (Unaudited) | Account | March 31, 2022 ($ thousands) | December 31, 2021 ($ thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 4,347,162 | 4,375,678 | | Short-term investments | 1,897,783 | 2,241,962 | | Total current assets | 6,948,139 | 7,613,880 | | Total assets | 8,021,388 | 8,645,949 | | **Liabilities and Equity** | | | | Total current liabilities | 1,376,306 | 1,599,555 | | Total liabilities | 2,135,888 | 2,402,962 | | Total equity | 5,885,500 | 6,242,987 | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three Months Ended March 31, 2022 ($ thousands) | Three Months Ended March 31, 2021 ($ thousands) | | :--- | :--- | :--- | | Product revenue, net | 261,573 | 106,117 | | Collaboration revenue | 45,053 | 499,755 | | **Total revenues** | **306,626** | **605,872** | | Research and development | 389,915 | 320,726 | | Selling, general and administrative | 294,573 | 182,106 | | **Total expenses** | **749,913** | **535,705** | | (Loss) income from operations | (443,287) | 70,167 | | **Net (loss) income** | **(434,274)** | **66,495** | | Net (loss) income per ADS - Basic | (4.24) | 0.73 | Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2022 ($ thousands) | Three Months Ended March 31, 2021 ($ thousands) | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | (236,563) | 125,095 | | Net cash provided by investing activities | 210,393 | 291,948 | | Net cash (used in) provided by financing activities | (11,267) | 107,419 | | Net (decrease) increase in cash | (28,437) | 520,401 | [Note 3. Collaborative and Licensing Arrangements](index=15&type=section&id=Note%203.%20Collaborative%20and%20Licensing%20Arrangements) Collaboration revenue decreased significantly due to a large one-time license fee from Novartis in the prior year Collaboration Revenue Breakdown (Q1 2022 vs Q1 2021) | Revenue from Collaborators | Three Months Ended March 31, 2022 ($) | Three Months Ended March 31, 2021 ($) | | :--- | :--- | :--- | | License revenue | — | 484,646 | | Research and development service revenue | 13,427 | 15,109 | | Right to access intellectual property revenue | 26,249 | — | | Other | 5,377 | — | | **Total** | **45,053** | **499,755** | - In January 2021, the company received a **$650 million upfront payment** from Novartis for the tislelizumab collaboration, of which **$484.6 million was recognized as license revenue in Q1 2021**[64](index=64&type=chunk)[68](index=68&type=chunk)[69](index=69&type=chunk) - In December 2021, the company entered an option and collaboration agreement with Novartis for ociperlimab, receiving a **$300 million upfront payment** in January 2022[70](index=70&type=chunk)[74](index=74&type=chunk)[75](index=75&type=chunk) - Under the Amgen collaboration, BeiGene's portion of co-development funding for pipeline assets was **$44.2 million in Q1 2022**, with a remaining commitment of **$746.8 million**[81](index=81&type=chunk) [Note 11. Product Revenue](index=25&type=section&id=Note%2011.%20Product%20Revenue) Net product revenue grew 146.5% to $261.6 million, driven by strong sales of BRUKINSA® and tislelizumab Net Product Sales by Product (Q1 2022 vs Q1 2021) | Product | Three Months Ended March 31, 2022 ($ thousands) | Three Months Ended March 31, 2021 ($ thousands) | | :--- | :--- | :--- | | BRUKINSA® | 104,325 | 22,090 | | Tislelizumab | 87,643 | 48,879 | | REVLIMID® | 21,660 | 16,629 | | XGEVA® | 13,499 | 14,454 | | BLINCYTO® | 11,866 | — | | **Total product revenue – net** | **261,573** | **106,117** | [Note 17. Commitments and Contingencies](index=29&type=section&id=Note%2017.%20Commitments%20and%20Contingencies) The company holds significant financial commitments of $1.87 billion, primarily for co-development and capital projects Summary of Commitments as of March 31, 2022 | Commitment Type | Amount ($ thousands) | | :--- | :--- | | Co-Development Funding (Amgen) | 746,844 | | Capital Commitments | 239,436 | | Purchase Commitments | 122,485 | | Research and Development Commitment | 26,579 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Product revenue grew significantly, but a drop in collaboration revenue and rising expenses led to a net loss [Results of Operations](index=39&type=section&id=Results%20of%20Operations) Total revenues fell 49.4% due to lower collaboration revenue, despite a 146.5% increase in product sales Key Operational Results (Q1 2022 vs Q1 2021) | Metric | Q1 2022 ($M) | Q1 2021 ($M) | Change (%) | | :--- | :--- | :--- | :--- | | Total Revenues | 306.6 | 605.9 | (49.4)% | | Product Revenue, net | 261.6 | 106.1 | 146.5% | | Collaboration Revenue | 45.1 | 499.8 | (91.0)% | | Total Expenses | 749.9 | 535.7 | 40.0% | | Net (Loss) Income | (434.3) | 66.5 | (753.1)% | - The increase in R&D expense was primarily due to a **$80.0 million (49.5%) increase in internal costs**, reflecting global expansion[188](index=188&type=chunk)[190](index=190&type=chunk) - The increase in SG&A expense was driven by a **$62.5 million rise in employee costs** and a **$20.8 million increase in external commercial expenses**[191](index=191&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains a strong liquidity position sufficient for the next 12 months despite significant future commitments Liquidity Position | Account | March 31, 2022 ($ thousands) | December 31, 2021 ($ thousands) | | :--- | :--- | :--- | | Cash, cash equivalents and restricted cash | 4,354,450 | 4,382,887 | | Short-term investments | 1,897,783 | 2,241,962 | | Total debt | 608,992 | 629,678 | - The company received an upfront cash payment of **$300 million from Novartis** in January 2022 for the ociperlimab collaboration[198](index=198&type=chunk) Material Cash Requirements as of March 31, 2022 | Obligation | Total ($ thousands) | Short Term ($ thousands) | Long Term ($ thousands) | | :--- | :--- | :--- | :--- | | Co-development funding commitment | 746,844 | 245,146 | 501,698 | | Debt obligations | 608,992 | 407,387 | 201,605 | | Capital commitments | 239,436 | 239,436 | — | | Purchase commitments | 122,485 | 64,143 | 58,342 | [Quantitative and Qualitative Disclosures About Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risks include interest rates and foreign currency, particularly the Chinese Renminbi - The company is exposed to foreign exchange risk from transactions in currencies like the **RMB, Euro, and Australian dollar**[232](index=232&type=chunk)[233](index=233&type=chunk) - The company's ability to convert RMB is subject to **PRC government controls**, potentially limiting fund remittances[236](index=236&type=chunk)[544](index=544&type=chunk) - A hypothetical **100-basis point change in interest rates** would impact investment value by approximately **$10 million**[229](index=229&type=chunk) [Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of the quarter-end - **Disclosure controls and procedures are effective** at a reasonable assurance level as of March 31, 2022[239](index=239&type=chunk) - In Q1 2022, the company implemented **new controls for key financial processes** including order-to-cash and R&D accruals[240](index=240&type=chunk) [PART II. OTHER INFORMATION](index=49&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=49&type=section&id=Item%201.%20Legal%20Proceedings) The company is engaged in an ongoing arbitration with a Bristol Myers Squibb company regarding a supply agreement - The company initiated an arbitration proceeding against BMS-Celgene in June 2020 over the **ABRAXANE® supply agreement in China**[242](index=242&type=chunk) [Risk Factors](index=49&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks in commercialization, clinical development, and operations in China [Risks Related to Commercialization](index=49&type=section&id=Risks%20Related%20to%20Commercialization) Key commercialization risks include market acceptance, intense competition, and securing adequate reimbursement - The company's medicines may **fail to achieve market acceptance** from physicians, patients, and payors[244](index=244&type=chunk)[245](index=245&type=chunk) - The company faces **substantial competition** from larger pharmaceutical companies and potential generic therapies[259](index=259&type=chunk)[260](index=260&type=chunk) - Successful commercialization depends on **achieving adequate reimbursement** from government and private payors[269](index=269&type=chunk)[270](index=270&type=chunk) [Risks Related to Clinical Development and Regulatory Approval](index=58&type=section&id=Risks%20Related%20to%20Clinical%20Development%20and%20Regulatory%20Approval) Drug development is subject to lengthy, expensive, and uncertain clinical trials and regulatory approval processes - Business success depends on **successful clinical development and regulatory approval**, a lengthy and uncertain process[290](index=290&type=chunk)[293](index=293&type=chunk) - **Clinical trials may fail or be delayed** due to safety, efficacy, or enrollment issues[296](index=296&type=chunk)[300](index=300&type=chunk) - **Regulatory approvals from the FDA, NMPA, and EMA are unpredictable** and can be delayed by external factors[306](index=306&type=chunk)[312](index=312&type=chunk) [Risks Related to Financial Position and Need for Additional Capital](index=68&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) The company has a history of significant net losses and may require additional capital to fund future operations - The company has an **accumulated deficit of $5.4 billion** and expects to incur further losses[345](index=345&type=chunk)[346](index=346&type=chunk) - The company **may need to obtain additional financing**, and failure to do so could delay or reduce programs[350](index=350&type=chunk)[354](index=354&type=chunk) - The company is exposed to **foreign currency exchange risk**, particularly with the Chinese RMB[357](index=357&type=chunk)[358](index=358&type=chunk)[360](index=360&type=chunk) [Risks Related to Doing Business in the PRC](index=93&type=section&id=Risks%20Related%20to%20Our%20Doing%20Business%20in%20the%20PRC) Operations in China face risks from political uncertainty, U.S.-China relations, and potential delisting under HFCAA - The company's ADSs may be **delisted from U.S. exchanges under the HFCAA** if the PCAOB cannot inspect its China auditor[507](index=507&type=chunk)[508](index=508&type=chunk) - To address HFCAA risk, the company has engaged a **U.S.-based auditor for FY2022** to satisfy PCAOB inspection requirements[510](index=510&type=chunk)[513](index=513&type=chunk) - The potential **AHFCA Act could shorten the delisting timeline** to 2023 if inspection issues are not resolved[515](index=515&type=chunk)[516](index=516&type=chunk)[517](index=517&type=chunk) - Operations are subject to uncertainty from **PRC political policies, U.S.-China relations, and government oversight**[499](index=499&type=chunk)[500](index=500&type=chunk)[501](index=501&type=chunk) - Dividend payments from PRC subsidiaries are **restricted by PRC regulations** and currency exchange controls[529](index=529&type=chunk)[530](index=530&type=chunk)[531](index=531&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=108&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[615](index=615&type=chunk) [Defaults Upon Senior Securities](index=108&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - None[615](index=615&type=chunk) [Mine Safety Disclosures](index=108&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[615](index=615&type=chunk) [Other Information](index=108&type=section&id=Item%205.%20Other%20Information) The company reported no other information required to be disclosed under this item - Not applicable[615](index=615&type=chunk) [Exhibits](index=108&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report, including officer certifications and XBRL data - The report includes a new consulting agreement with Jane Huang, effective April 3, 2022, as an exhibit[617](index=617&type=chunk)

Financial Performance - The company reported a cumulative loss of CNY 37.33 billion as of December 31, 2021, due to high investment in drug research and development [3]. - The company does not plan to distribute profits or increase capital reserves through stock conversion for the 2021 fiscal year [7]. - The company faces risks of continued losses, which may expand if drug development projects fail or do not gain market acceptance [4]. - The company reported a total revenue of RMB 1.5 billion for the year 2021, representing a year-over-year increase of 25% [12]. - The net loss attributable to shareholders for 2021 was RMB -974,767.30 million, an improvement from RMB -1,138,380.40 million in 2020 [21]. - The net cash flow from operating activities for 2021 was RMB -828,474.80 million, which increased from RMB -517,953.50 million in 2020 [22]. - The company acknowledged various risks and uncertainties that may impact its future performance and financial condition [10]. - The company plans to retain most of its available funds and profits for business development, indicating no cash dividends are expected in the near term [152]. - The company’s future profitability is contingent on the success of its drug development projects and their acceptance in the market, which remains uncertain [150]. Research and Development - Research and development expenses for the year were CNY 9.54 billion, representing a 6.66% increase compared to the previous year [3]. - The company has established competitive advantages in research, clinical development, commercialization, and production, aiming to drive future business growth [4]. - The company is focused on expanding its production and manufacturing facilities to support ongoing drug development and commercialization efforts [4]. - The company has established partnerships with three leading research organizations to accelerate drug development timelines [12]. - The company has advanced production capabilities with a solid oral solid dosage manufacturing facility in Suzhou, capable of producing 1 billion tablets and capsules annually, and plans to expand to 600 million doses [34]. - The company is actively pursuing clinical trials, with over 90 ongoing or planned trials for more than 30 drugs and candidates, including over 30 key or potential registration trials [33]. - The company has established 13 core technology platforms to support drug development, enhancing its capabilities in early drug discovery to commercialization [125]. - The company has advanced 12 self-developed clinical candidates into clinical trials and commercialization stages, supported by a global clinical development team of over 2,200 employees executing more than 90 ongoing or planned clinical trials for over 30 drugs and candidates [122]. Product Development and Commercialization - The company emphasizes the importance of successful commercialization of approved drugs and the ability to develop and market new drugs [9]. - The company is focused on developing innovative drugs to improve treatment outcomes and drug accessibility for patients globally [50]. - The company has three self-developed drugs approved for market, including Baiyueze® (Zebutinib), Baizean® (Tislelizumab), and Baihuize® (Pamiparib), with Baiyueze® approved in over 45 markets [32]. - The company has commercialized multiple proprietary cancer drugs, focusing on maximizing market share and minimizing off-target effects [56]. - The company is currently selling its self-developed drugs, including BRUKINSA® and Bai Ze An®, in China and the U.S., but faces challenges in commercialization due to limited experience [157]. - The company is expanding its market presence in Europe, targeting a 15% market share by the end of 2023 [12]. - The company has established strategic partnerships with multiple biotech firms, enhancing its research and commercialization capabilities across various innovative therapies [148]. Clinical Trials and Regulatory Approvals - The company has initiated or completed over 20 pivotal clinical trials for the evaluation of Tislelizumab, including 17 Phase 3 trials and 4 key Phase 2 trials globally [60]. - The company has received conditional approvals for several drugs, including 2L/3L NSCLC approved on January 6, 2022, and 2L ESCC approved on April 15, 2022 [74]. - The company is conducting multiple Phase 3 trials for Tislelizumab in various cancers, including NSCLC and ESCC, to evaluate its efficacy and safety [86]. - The company has received approval or submitted applications for products during the reporting period, indicating significant progress in new drug development [129]. - The company has signed collaboration agreements with partners like Amgen, Novartis, and Bristol-Myers Squibb, but there are risks associated with achieving the expected financial and operational synergies from these partnerships [183]. Market and Competitive Landscape - The global oncology drug market is projected to reach $304.8 billion by 2025 and $482.5 billion by 2030, with a CAGR of 9.6% from 2025 to 2030 [106]. - The company faces significant challenges in clinical trial patient recruitment and the complexities of scaling up production for biologics [119][120]. - The company’s ability to maintain market recognition for its drugs is critical, as competition from established therapies and other innovative drugs poses a significant threat [156]. - The company may not be able to generate significant product sales revenue due to challenges in developing and maintaining internal sales and distribution capabilities [159]. - The company faces risks related to the compliance of Contract Manufacturing Organizations (CMOs) with production regulations, which could lead to delays and additional costs in drug commercialization [179]. Workforce and Organizational Structure - The company experienced a 57% increase in employee count, growing from approximately 5,100 at the beginning of 2021 to 8,000 by the end of 2021 [198]. - The company has 2,949 R&D personnel, an increase from 2,076 in the previous period, representing 36.7% of total employees [136]. - The company faces significant challenges in recruiting and retaining skilled personnel necessary for product development and commercialization due to high competition in the industry [200]. - The company’s ability to manage growth effectively is crucial for its future financial performance and drug development capabilities [198]. Risks and Challenges - The company has experienced significant regulatory scrutiny, as evidenced by the suspension of ABRAXANE® in China due to compliance issues with a CMO [178]. - The company faces risks of delayed or denied regulatory approvals, which could reduce its target market and potential revenue [165]. - The lengthy and costly process of obtaining regulatory approvals poses a risk to the company’s ability to commercialize its candidates [163]. - The company is at risk of losing its listing on the Shanghai Stock Exchange if it fails to meet specific financial criteria, including negative net profit and revenue below 100 million yuan [151]. - The company must ensure that all clinical trials comply with applicable regulations, as non-compliance could lead to unreliable data and additional regulatory hurdles [180].

Financial Performance - BeiGene reported a significant increase in revenue, reaching $1.2 billion for the year, representing a 30% year-over-year growth[9]. - BeiGene anticipates total revenue guidance of $1.5 billion for the next fiscal year, indicating a 25% growth target[9]. - The company has incurred significant expenses related to research and development, sales, and administrative costs[182]. - Cumulative losses since inception amount to $5 billion as of December 31, 2021[182]. - The company expects to continue incurring net losses in the foreseeable future due to ongoing drug development and commercialization efforts[183]. - Cash used in operating activities was $1.3 billion for the years ended December 31, 2021, 2020, and $750.3 million for 2019[185]. - The company has cash and cash equivalents of $4.4 billion, restricted cash of $7.2 million, and short-term investments of $2.2 billion as of December 31, 2021[192]. - The company anticipates sufficient cash, cash equivalents, and short-term investments to meet operational needs for at least the next 12 months[187]. Research and Development - The company is focused on research and innovation, with a team of over 700 scientists dedicated to oncology research[17]. - BeiGene's R&D expenses were approximately $600 million, accounting for 50% of total revenue, highlighting its commitment to innovation[9]. - The company aims to advance its clinical candidates, with several drugs expected to enter late-stage trials in the coming year[10]. - The company is advancing several clinical candidates, including ociperlimab (TIGIT antibody) and BGB-11417 (BCL2 inhibitor), with key clinical trials expected to start in 2022[17]. - The company has a robust pipeline with over 20 drug candidates in development, targeting various cancers and immune-related conditions[53]. - The company is actively pursuing new indications for its existing products, including applications for R/M cervical cancer and R/M ESCC[53]. - The company is committed to conducting post-approval verification clinical trials as part of its accelerated approval strategy[54]. Market Expansion and Commercialization - The company plans to expand its market presence in Europe and Asia, targeting a 20% increase in market share by 2023[9]. - The company has authorized commercialization of 13 approved drugs in the Chinese market, leveraging its commercialization capabilities[15]. - The commercial team in China consists of over 3,100 employees, focusing on extensive market coverage and aiming to become the preferred partner in oncology drug commercialization[19]. - The company plans to establish a commercial-stage biopharmaceutical production and clinical development center in New Jersey, USA[16]. - The company is exploring potential acquisitions to bolster its pipeline and expand its therapeutic offerings[10]. - The company is committed to establishing a leading reputation in the global biotechnology sector through effective commercialization of differentiated drugs[20]. Strategic Partnerships and Collaborations - The company has established strategic partnerships to enhance its drug development capabilities and market access[10]. - The collaboration agreement with Amgen includes a commitment to share global development costs, with BeiGene potentially contributing up to $1.25 billion in development services and cash during the collaboration period[90]. - The company has signed commercial supply agreements with various third-party manufacturers, including Catalent for the production of Baiyueze® in Kansas City, USA[87]. - The company entered a strategic collaboration with Amgen for the commercialization of anti-tumor products, effective January 2, 2020[121]. - The company has a market development agreement with a subsidiary of Novartis for promoting and marketing in the vast Chinese market[24]. Regulatory and Compliance Challenges - The company must obtain regulatory approvals for its candidate drugs, which is a lengthy and costly process with inherent uncertainties[125]. - Regulatory approvals in different countries may vary, potentially delaying or preventing the commercialization of candidate drugs[126]. - The company faces significant competition from major pharmaceutical and biotechnology companies, which may hinder its ability to develop and commercialize drugs successfully[128]. - The company is subject to various healthcare laws that may impose significant compliance costs and risks of penalties for violations[143]. - Non-compliance with applicable healthcare laws could lead to severe consequences, including removal from federal healthcare programs and reputational damage[143]. Intellectual Property and Competition - The company holds 40 US patents and 24 Chinese patents, along with multiple pending patent applications in the US and China[106]. - The company faces competition from generic drug manufacturers, which may challenge the validity of its patents, impacting potential sales of its products[199]. - The company’s ability to protect intellectual property globally is uncertain, which could significantly harm the company's competitive position and business[200]. - The company may not be able to secure exclusive rights to jointly owned patents, which could enable competitors to market similar products[200]. Clinical Trials and Development Risks - Clinical development is costly and time-consuming, with uncertain outcomes; early trial results may not predict later trial results[149]. - The success of the company's drug candidates relies on various factors, including successful recruitment for clinical trials and obtaining regulatory approvals[148]. - The company may incur additional costs or face delays if its drug candidates fail to demonstrate safety and efficacy as required by regulatory agencies[150]. - The company faces significant risks related to its intellectual property, particularly in obtaining and maintaining patent protection for its drugs and candidates[194]. Financial Risks and Future Outlook - The company may require additional financing to fund operations and drug development, with potential dilution of shareholder equity[186]. - The company faces risks related to credit quality deterioration of distributors and customers, which could negatively impact cash flow and financial performance[192]. - The company may experience dilution of shareholder equity if it raises additional capital through equity issuance or convertible debt[189]. - The company’s financial performance may be negatively impacted by potential defaults from distributors and customers due to bankruptcy or liquidity issues[192].

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 ...