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 ...

Financial Performance - The company reported a revenue increase of 50% year-over-year, reaching $300 million in the latest quarter[6]. - Total revenue decreased from $321.2 million for the six months ended June 30, 2019, to $117.7 million for the same period in 2020, a decline of 63.4%[28]. - Product revenue increased by 1.8% from $115.6 million in the previous year to $117.7 million in 2020, primarily due to sales of Tislelizumab and BRUKINSA®[31]. - The company reported a net loss of $100 million for the quarter, reflecting increased R&D and operational expenses[6]. - The company reported a net loss of $701.3 million for the six months ended June 30, 2020, compared to a net loss of $254.0 million for the same period in 2019, resulting in a cumulative loss of $2.7 billion[44]. - The company reported a basic and diluted loss per American Depositary Share of $(0.69) for the six months ended June 30, 2020, compared to $(0.33) for the same period in 2019, reflecting an increase in loss per share of approximately 109.1%[125]. Research and Development - The company is focused on expanding its oncology pipeline, with several candidates in clinical trials expected to advance in the next 12 months[7]. - Research and development expenses rose by $183.2 million or 45.0% to $590.3 million for the six months ended June 30, 2020, compared to $407.1 million in the prior year[32]. - The company has initiated late-stage clinical trials for BRUKINSA® and Tislelizumab, including 27 registration or registrational trials targeting at least 15 distinct cancer indications[11]. - The company is committed to maintaining and expanding its regulatory approvals for existing and candidate drugs[7]. - The company anticipates a substantial increase in R&D costs in the foreseeable future as it continues to support clinical trials for its drugs and candidates[25]. Commercialization and Market Expansion - BeiGene successfully commercialized BRUKINSA® (Zanubrutinib) in the US and China, contributing to revenue growth[6]. - The company plans to enhance its sales and marketing capabilities to support the launch of new drugs upon approval[7]. - The company is exploring strategic collaborations and licensing agreements to enhance its drug development and commercialization efforts[7]. - The company plans to launch additional licensed products from partners in China, including KYPROLIS® and BLINCYTO® from Amgen[10]. - The company has a strategic collaboration with Amgen to commercialize Amgen's oncology products in China, including the clinical and late-stage pipeline[12]. Financial Position and Cash Flow - Cash, cash equivalents, restricted cash, and short-term investments totaled approximately $2,723.7 million as of June 30, 2020[37]. - The company reported a net interest income of $7.8 million for the six months ended June 30, 2020, up 5.9% from $7.4 million in the same period of 2019[36]. - Cash used in operating activities was $604.9 million for the six months ended June 30, 2020, compared to $218.1 million for the same period in 2019[47]. - The company expects to continue incurring losses in the foreseeable future due to ongoing drug development and commercialization efforts[53]. - The company plans to fund ongoing research and clinical development, including key trials for its drug candidates in China and globally, which will significantly increase expenditures[54]. Strategic Collaborations and Partnerships - The company has partnered with leading pharmaceutical and biotechnology companies to develop and commercialize innovative drugs in China and the Asia-Pacific region[12]. - The company signed an exclusive licensing agreement with Beijing Danyu Biopharmaceutical Co., Ltd. to develop and commercialize neutralizing antibodies against COVID-19 globally outside Greater China[13]. - The company has initiated a clinical development collaboration with Hutchison China MediTech Limited to evaluate the safety and efficacy of two candidate drugs in combination with Tarelizumab for multiple solid tumors[16]. - The company is collaborating with Assembly Biosciences, Inc. to develop three clinical-stage hepatitis B core inhibitors in China, with ABI-H0731 and ABI-H2158 in Phase 2 trials and ABI-H3733 in Phase 1[14]. Regulatory Approvals and Compliance - The company announced that BRUKINSA® received approval for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL) who have received at least one prior therapy[16]. - The company announced the acceptance of a New Drug Submission (NDS) for Baiyueze® for the treatment of Waldenström's macroglobulinemia (WM) by the Canadian drug regulatory authority, which will be prioritized for review[13]. - The company is actively pursuing regulatory approvals for additional indications for its existing drugs to enhance revenue potential[53]. Employee and Shareholder Information - The total employee compensation cost for the six months ended June 30, 2020, was $290.3 million, compared to $191.2 million for the same period in 2019[70]. - The company has a global team of approximately 4,200 employees as of June 30, 2020, an increase from 3,359 employees as of December 31, 2019[70]. - The company has granted stock options that could allow Orey Qiang to acquire up to 20,705,156 additional shares, subject to vesting conditions[75]. - The company has a trust account holding 10,000,000 shares for Orey Qiang, which represents 0.98% of the total shares[74]. Governance and Compliance - The company’s governance framework aims to enhance transparency, accountability, and integrity in its operations[107]. - The audit committee consists of two independent non-executive directors and one non-executive director, ensuring compliance with financial reporting and internal controls[109]. - The company has adhered to applicable corporate governance codes during the reporting period[108]. - The company continues to review and monitor corporate governance practices to ensure compliance with high standards[110].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________ FORM 10-Q ___________________________________________________________ (Mark One) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT P ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________ FORM 10-Q ___________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 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 _ ...

Commercialization and Market Expansion - BeiGene successfully commercialized BRUKINSA™ in the US and 百澤安® in China, with regulatory approvals for adult patients with specific types of lymphoma[8] - The company aims to expand the approval and commercialization of BRUKINSA and替雷利珠單抗 for additional indications and regions[8] - BeiGene is focused on the successful commercialization of licensed drugs in China, including ABRAXANE®, 瑞復美®, and others from various partners[8] - The company is enhancing its sales and marketing capabilities and plans to launch new drugs upon approval[9] - The company is focused on the market access, acceptance, and reimbursement rates for its drugs and candidates[9] - The company has established significant commercial capabilities in both China and the United States, with two internally developed drugs and three licensed drugs currently on the market[11] - Five licensed drugs are expected to enter the Chinese market within the next one to two years[11] - The company plans to launch additional licensed products from partners, including Amgen's XGEVA, Kyprolis, and Blincyto in China[11] - The company has submitted three new indication applications for regulatory approval in China[11] - The company has a commercial team of over 100 people promoting BRUKINSA in the United States[18] Clinical Development and Trials - BeiGene is actively involved in clinical trials and research projects, with a focus on advancing candidate drugs through clinical phases[9] - The company has a global clinical development team of over 1,100 people managing more than 60 ongoing or planned clinical trials involving over 7,500 patients and healthy subjects[12] - The company is conducting late-stage clinical trials for BRUKINSA and Tislelizumab, including 26 registration trials for 15 distinct cancer indications[12] - The company has initiated 12 global key studies and 26 critical or potential registration studies, enrolling over 7,500 patients and healthy volunteers[15] - The company has multiple candidate drugs in Phase 3 trials, including AMG 510 for solid tumors and AMG 596 for glioblastoma[35] - The company is conducting a Phase 3 head-to-head trial (ASPEN) comparing Zebutinib as a monotherapy against Ibrutinib for patients with Waldenström's macroglobulinemia, with significant results reported and follow-up studies ongoing[55] - The company is exploring additional pivotal trials for Tislelizumab as a monotherapy and in combination with standard treatments for various solid and hematological tumors[56] Strategic Partnerships and Collaborations - A strategic partnership with Amgen was established in October 2019 to commercialize Amgen's anti-tumor products in China, including up to 20 clinical and late-stage pipeline products[13] - The company has a collaboration agreement with Amgen for the commercialization of three cancer drugs in China, with a profit-sharing model during the commercialization period[94] - The collaboration agreement includes a commitment to jointly fund global development costs for 20 cancer pipeline products, with a maximum contribution of $1.25 billion from the company[95] - The strategic cooperation agreement with Amgen includes the commercialization of three anti-tumor products in China for a period of five to seven years, contingent on the sale of at least one product[108] - The strategic partnership with Bristol-Myers Squibb includes exclusive rights to commercialize approved cancer treatment drugs in China, which began marketing in September 2017[108] Regulatory Approvals and Compliance - The company is committed to maintaining and expanding regulatory approvals for its drugs and candidates[9] - The company has received fast track approval qualifications for certain drugs in China[17] - The company is positioned to benefit from recent regulatory reforms in China, which aim to accelerate drug development and approval processes[15] - The company must demonstrate the safety and efficacy of its candidate drugs in well-controlled clinical trials before obtaining regulatory approval[113] - The approval process for new drug applications is lengthy and uncertain, potentially impacting the company's revenue generation capabilities[115] - The company is subject to strict regulations from the FDA, NMPA, EMA, and other health authorities regarding drug manufacturing standards, which include quality control and documentation requirements[117] Financial Performance and Funding - The cumulative deficit of the company reached $2 billion and $1 billion as of December 31, 2019, and 2018, respectively[144] - The company has incurred significant net losses since its establishment and expects to continue doing so for the foreseeable future[144] - The company has raised approximately $2.78 billion through the issuance of common stock in the form of American Depositary Shares to Amgen in January 2020[146] - The company expects to incur significant losses in the foreseeable future, with an investment of up to $1.25 billion for the global development of 20 pipeline drugs in collaboration with Amgen[145] - The company may need to seek additional financing through public or private sales, debt financing, or other sources to support operations[148] Intellectual Property and Competition - The company holds global commercial rights for several cancer drugs, including QARZIBA and BRUKINSA[17] - The company faces potential competition from generics for ABRAXANE and other products, which could significantly impact potential sales[103] - The company relies on trade secrets and non-patented technologies to protect its proprietary technologies and processes[105] - The company anticipates facing competition from generic drug manufacturers for its cancer treatment drugs, even if patent protection is obtained[156] - The company’s ability to exclude others from commercializing similar products may be limited by the expiration of patents before the commercialization of new candidates[156] Manufacturing and Supply Chain - The company has advanced small molecule and biologics manufacturing facilities in China to support internal product launches and future demand[12] - The company relies on third-party manufacturers for commercial-scale production of its drugs, including BRUKINSA and Tislelizumab[116] - The company experienced supply interruptions for ABRAXANE in 2019 and 2020, which could recur in the future[168] - The company relies on multiple suppliers for raw materials, but some supply chains may depend on single-source suppliers, posing potential risks[171] - The company is working closely with the supplier to restore ABRAXANE supply as quickly as possible, including rectification of existing production facilities[170] Risks and Challenges - The company may face risks related to the effectiveness and market recognition of its drugs, which could limit sales and profitability[107] - The company is aware of various risks that could adversely affect its business and financial condition, which investors should consider[106] - The company may encounter delays in drug development due to disagreements with regulatory bodies or failure to demonstrate safety and efficacy[128] - The company faces significant risks related to regulatory approvals, which may delay or prevent the commercialization of its drug candidates[127] - The company may face challenges in recruiting, training, and retaining marketing and sales personnel due to competition from other pharmaceutical and biotechnology companies[111] Employee and Management Considerations - Employee count increased by approximately 62% from 2,070 at the beginning of 2019 to 3,359 by the end of the year[181] - The company relies heavily on key management personnel, and their departure could hinder the achievement of research and commercialization goals[179] - Attracting and retaining qualified scientific, clinical, manufacturing, and sales personnel is crucial for the company's success[179] - The company does not have "key person" insurance for any of its management or employees, increasing risk if key personnel leave[179]