BGB-10188

Recorded product revenue of $339.0 million and $1.3 billion for the fourth quarter and full year, respectively, increasing 72.3% and 97.9% from the prior-year periods BRUKINSA® product revenue totaled $176.1 million and $564.7 million for the quarter and full year, respectively, increasing 101% and 159% from the prior-year periods Tislelizumab product revenue totaled $102.2 million and $422.9 million for the quarter and full year, respectively, increasing 88% and 66% from the prior-year periods BRUKINSA now approved in the U.S. to treat adult patients with relapsed/refractory (R/R) and first-line chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in the EU to treat CLL Presented data from final analysis of the Phase 3 ALPINE trial demonstrating progression-free survival superiority for BRUKINSA versus IMBRUVICA® in R/R CLL/SLL as a late breaking abstract at ASH 2022; simultaneously published in The New England Journal of Medicine BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today reported financial results for the fourth quarter and full year 2022, recent business highlights, and upcoming milestones. “We had an outstanding fourth quarter and 2022, with revenues from our two cornerstone medicines, BRUKINSA® and tislelizumab, dramatically increasing as our global team continues to bring these innovative therapies to more patients and their caregivers,” said John V. Oyler, Co-Founder, Chairman and Chief Executive Officer at BeiGene. “The final progression-free survival (PFS) analysis of the ALPINE trial demonstrating superior efficacy and a favorable cardiac safety pro to IMBRUVICA® in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and the recent U.S. FDA approval for BRUKINSA in adult patients with CLL/SLL were the most impactful of many recent milestones for our company and a testament to our commitment to following the science.” “Our fourth quarter results continue to demonstrate BeiGene’s commercial capability as well as our commitment to driving operational and financial excellence,” said Julia Wang, Chief Financial Officer at BeiGene. “With our strong cash position and total product revenue reaching $1.3 billion in 2022, BeiGene is well positioned to leverage its global scale and financial strength for long-term growth.” Fourth Quarter and Full Year 2022 Financial Results Revenue for the fourth quarter and full year 2022 was $380.1 million and $1.4 billion, respectively, compared to $214.0 million and $1.2 billion in the prior-year periods. The increase in total revenue in the quarter compared to the prior year is primarily attributable to sales of our internally developed products, BRUKINSA and tislelizumab; sales of in-licensed products from Amgen; and collaboration revenue from the Novartis agreements. Product revenues totaled $339.0 million and $1.3 billion for the fourth quarter and full year 2022, respectively, compared to $196.8 million and $634.0 million in the prior-year periods, and include: Global sales of BRUKINSA of $176.1 million and $564.7 million for the fourth quarter and full year 2022, respectively, compared to $87.6 million and $218.0 million in the prior-year periods; Sales of tislelizumab in China of $102.2 million and $422.9 million for the fourth quarter and full year 2022, respectively, compared to $54.4 million and $255.1 million in the prior-year periods; Sales of Amgen in-licensed products in China of $27.7 million and $114.6 million for the fourth quarter and full year 2022, respectively, compared to $20.3 million and $58.8 million in the prior-year periods. We began selling Amgen's BLINCYTO® (blinatumomab) in August 2021. Additionally, prior-year period sales do not include sales of KYPROLIS® (carfilzomib), which was launched in China in January 2022; Sales of BMS in-licensed products in China of $21.4 million and $94.3 million for the fourth quarter and full year 2022, respectively, compared to $29.9 million and $89.7 million in the prior-year periods; and Collaboration revenue totaled $41.1 million and $161.3 million for the fourth quarter and full year 2022, respectively, resulting from the partial recognition of the upfront payments from Novartis related to the tislelizumab and ociperlimab agreements, which were entered into in the first and fourth quarters of 2021. This compared to $17.2 million and $542.3 million in the prior-year periods. Full year 2021 collaboration revenue benefited from the timing of revenue recognition from the upfront license payment from Novartis under the tislelizumab agreement. Cost of Sales for the fourth quarter and full year 2022 were $73.5 million and $286.5 million, respectively, compared to $48.5 million and $164.9 million in the prior-year periods. Cost of sales increased primarily due to increased product sales of BRUKINSA and tislelizumab, as well as sales of BLINCYTO, which commenced in August 2021, and KYPROLIS and POBEVCY®, which commenced in January 2022; Gross Margin as a percentage of global product sales for the fourth quarter and full year 2022 was 78.3% and 77.2%, respectively, compared to 75.3% and 74.0% in the prior-year periods. The gross margin percentage increased in both the quarter-over-quarter and year-over year periods primarily due to a proportionally higher sales mix of global BRUKINSA sales compared to other products in our portfolio and compared to lower margin sales of in-licensed products, as well as lower costs per unit for both BRUKINSA and tislelizumab, partially offset by lower average selling prices in China for both BRUKINSA and tislelizumab. Operating Expenses for the fourth quarter and full year 2022 were $775.2 million and $2.9 billion, respectively, compared to $737.2 million and $2.5 billion in the prior-year periods. R&D Expenses for the fourth quarter and full year 2022 were $446.0 million and $1.6 billion, respectively, compared to $430.5 million and $1.5 billion in the prior-year periods. The increase in R&D expenses was primarily attributable to increases in headcount and costs related to investment in our discovery and development activities, including our continued efforts to internalize research and clinical development activities, partially offset by lower fees paid to clinical research organizations (CROs) for clinical trials. Upfront fees related to in-process R&D for in-licensed assets totaled $48.7 million and $68.7 million in the fourth quarter and full year 2022, respectively, compared to $30.0 million and $83.5 million in the prior-year periods. Employee share-based compensation expense was $35.0 million and $139.3 million for the fourth quarter and full year 2022, respectively, compared to $30.6 million and $114.4 million in the prior-year periods; and SG&A Expenses for the fourth quarter and full year 2022 were $329.0 million and $1.3 billion, respectively, compared to $306.5 million and $990.1 million in the prior-year periods. The increase in SG&A expenses was primarily attributable to increased headcount, largely related to continued expansion of our commercial teams, and higher external commercial expenses, including market access studies and promotional activities. Employee share-based compensation expense was $43.2 million and $163.8 million for the fourth quarter and full year 2022, respectively, compared to $32.4 million and $126.4 million for the prior-year periods. Net Loss for the fourth quarter of 2022 was $445.3 million, or $0.33 per share and $4.29 per ADS, compared to $590.7 million, or $0.48 per share and $6.22 per ADS in the prior year period. The decrease in net loss is primarily attributable to improved operating leverage due to growing product revenues exceeding operating expense growth. The company expects this trend to continue into 2023. Net loss for full year 2022 was $2.0 billion, or $1.49 per share and $19.43 per ADS, compared to $1.5 billion, or $1.21 per share and $15.71 per ADS in the prior-year period. Net loss for 2022 was unfavorably impacted by other non-operating expenses of $223.9 million, primarily related to foreign exchange losses resulting from the strengthening of the U.S. dollar and the revaluation impact of foreign currencies held in U.S. functional currency subsidiaries. Net loss for the full year 2021 was positively impacted by the timing of revenue recognition related to the Novartis tislelizumab collaboration agreement. The company recognized $484.6 million in the full year 2021 of the $650.0 million upfront payment received. Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $4.5 billion as of December 31, 2022, compared to $6.6 billion as of December 31, 2021. In the fourth quarter of 2022, cash used in operating activities was $318.2 million, primarily due to our net loss of $445.3 million, offset by non-cash charges of $127.3 million; capital expenditures were $121.4 million; and cash used in financing activities was $110.4 million; In the fourth quarter of the prior year, cash used in operating activities was $507.8 million, primarily due to our net loss of $590.7 million, offset by non-cash charges of $92.7 million; capital expenditures were $115.0 million; and cash provided by financing activities was $3.4 billion, primarily due to the STAR Market offering in December of 2021; and For the full year 2022, cash used in operating activities was $1.5 billion, primarily due to our net loss of $2.0 billion, inclusive of $223.9 million of other losses due primarily to the strengthening of the U.S. dollar and the related revaluation of foreign currencies held by U.S. functional currency subsidiaries, non-cash charges of $374.8 million and a decrease in our net operating assets and liabilities of $132.4 million. For the full year 2021, cash used in operating activities was $1.3 billion, primarily due to our net loss of $1.5 billion and an increase in our net operating assets and liabilities of $118.3 million, partially offset by non-cash charges of $277.4 million; capital expenditures were $262.9 million; and cash provided by financing activities was $3.6 billion, primarily due to the net proceeds from the STAR Market offering in December of 2021. Recent Business Highlights Commercial Operations Product sales increased 72.3% and 97.9% in the fourth quarter and full year of 2022, respectively, compared to the prior-year periods, primarily due to increased sales of our internally developed products, as well as increased sales of in-licensed products from Amgen and Bio-Thera; Global sales of BRUKINSA totaled $176.1 million and $564.7 million in the fourth quarter and full year 2022, representing growth of 101% and 159%, respectively, compared to the prior-year periods; U.S. sales of BRUKINSA totaled $125.3 million and $389.7 million in the fourth quarter and full year 2022, respectively, representing growth of 124% and 237%, compared to the prior-year periods. U.S. sales growth continued in the quarter, driven again by increasing uptake in mantle cell lymphoma (MCL), Waldenström’s macroglobulinemia (WM), and marginal zone lymphoma (MZL). BRUKINSA sales in China totaled $40.9 million and $150.3 million in the fourth quarter and full year 2022, respectively, representing growth of 33% and 49% compared to the prior-year periods, driven by increases in all approved indications; Sales of tislelizumab in China totaled $102.2 million and $422.9 million in the fourth quarter and full year 2022, respectively, representing growth of 88% and 66% compared to the prior-year periods. Continued increase in new patient demand from broader reimbursement and further expansion of our salesforce and hospital listings continued to drive increased market penetration and market share for tislelizumab; Secured National Reimbursement Drug List (NRDL) inclusion of four additional indications in China, with nine approved tislelizumab indications now included. New indications covered as of March 1, 2023, are for: Certain adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC); Adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, and certain patients with advanced colorectal cancer (CRC); Adult patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have progressed after or are intolerant of prior first-line standard chemotherapy; and As a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC); and KYPROLIS was included in the NRDL for the first time for the treatment of adult patients with R/R multiple myeloma who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent. XGEVA® was successfully renewed for NRDL inclusion for the treatment of patients with giant cell tumor of the bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity. Regulatory Progress and Development Programs BRUKINSA® (zanubrutinib), a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects, approved in more than 65 markets including the U.S., China, European Union (EU), Great Britain, Canada, Australia, South Korea and Switzerland in selected indications and under development for additional approvals globally. The global BRUKINSA development program includes more than 4,800 subjects enrolled to-date in 29 countries and regions. In January 2023, announced U.S. FDA approval for the treatment of adult patients with R/R and first-line CLL/SLL; Announced European Commission (EC) approval for the treatment of adult patients with treatment-naïve (TN) or R/R CLL; Presented results from a final analysis of the Phase 3 ALPINE trial demonstrating superior PFS versus IMBRUVICA® in adult patients with R/R CLL/SLL, as assessed by an independent review committee (IRC) and investigator, as part of a late breaking abstract session at the 64th American Hematology Society (ASH) Annual Meeting, with simultaneous publication in The New England Journal of Medicine; Presented other key data from the BRUKINSA clinical development programs at ASH 2022, including an oral presentation of results from the MAGNOLIA trial in MZL and a poster with updated results in acalabrutinib-intolerant patients with B-cell malignancies; Announced approvals in Brazil for the treatment of adult patients with WM and adult patients with R/R MZL who have received at least one anti-CD20-based regimen; Received marketing authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain for the treatment of adult patients with CLL, and those with MZL who have received at least one prior anti-CD20-based therapy; and Expanded BRUKINSA's registration program globally, including 34 launches in 20 markets since January 1, 2022. Tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages; approved in China in 10 indications and under development for additional approvals globally. The global tislelizumab clinical development program includes more than 11,800 subjects enrolled to-date in 31 countries and regions. Announced China National Medical Products Administration (NMPA) approval of BLA application for tislelizumab in combination with chemotherapy as a first-line treatment for patients with locally advanced unresectable or metastatic G/GEJ adenocarcinoma with high PD-L1 expression, which is the tenth approved indication in China for tislelizumab; Announced acceptance by the NMPA of a supplemental biologics license application (sBLA) in patients with first-line unresectable or metastatic hepatocellular carcinoma (HCC); Filed new drug application for tislelizumab in Brazil seeking marketing authorization for use in first- and second-line NSCLC and second-line esophageal cancer, marking BeiGene's first application for tislelizumab in Latin America; and Presented results from the RATIONALE-301 (NCT03412773), RATIONALE-305 (NCT03777657) and RATIONALE-306 (NCT03783442) trials at the 2023 ASCO Gastrointestinal Cancers Symposium, including positive interim overall survival (OS) data for a combination of tislelizumab and chemotherapy in first-line gastric or gastroesophageal junction (G/GEJ) cancer patients whose tumors express PD-L1. Ociperlimab (BGB-A1217), an investigational anti-TIGIT monoclonal antibody with competent Fc function. The global ociperlimab development program includes 17 countries and regions, and more than 1,600 subjects have been enrolled. Presented Phase 1 clinical data for checkpoint inhibitor-experienced advanced NSCLC and extensive-stage small cell lung cancer (SCLC) (NCT04047862) at ESMO-IO 2022. BGB-11417, an investigational highly selective and highly potent inhibitor of BCL-2, being developed as monotherapy or in combination with zanubrutinib +/- obinutuzumab in B-cell malignancies, in combination with azacytidine in AML and MDS and as monotherapy and in combination with dexamethasone and in combination with carfilzomib in multiple myeloma. The global BGB-11417 development program includes six countries and regions, and more than 350 subjects have been enrolled. Presented Phase 1 clinical data for non-Hodgkin's lymphoma, CLL, acute myeloid leukemia (AML) and multiple myeloma (MM) (NCT04883957, NCT04277637, NCT04771130, and NCT04973605) at ASH 2022. BGB-A445, an investigational non-ligand competing OX40 monoclonal antibody, being developed as monotherapy or in combination with tislelizumab. Initiated patient dosing in a Phase 2 basket trial as monotherapy and in combination with tislelizumab in melanoma, renal cell cancer (RCC) and bladder cancer (NCT05661955). Early-Stage Programs Continued to advance our early-stage clinical pipeline of internally developed product candidates at dose escalation stage, including: BGB-B167: an investigational first-in-class CEA x 4-1BB bispecific antibody, as a monotherapy and in combination with tislelizumab in patients with selected CEA-expressing advanced or metastatic solid tumors, including colorectal cancer (CRC); BGB-A425: an investigational TIM-3 antibody, in combination with tislelizumab in patients with head and neck squamous cell carcinoma (HNSCC), NSCLC and RCC; BGB-15025: an investigational, first-in-class hematopoietic progenitor kinase 1 (HPK1) inhibitor as monotherapy or in combination with tislelizumab in solid tumors; BGB-16673: an investigational Chimeric Degradation Activating Compound (CDAC), targeting BTK protein degradation as monotherapy in B cell malignancies; BGB-24714: an investigational Second Mitochondrial-derived Activator of Caspase, or SMAC, mimetic as monotherapy or in combination with paclitaxel in advanced solid tumors; BGB-10188: an investigational PI3Kδ inhibitor as monotherapy or in combination with BRUKINSA in hematology malignancies, or in combination with tislelizumab in solid tumors; and BGB-23339: a potent, allosteric investigational tyrosine kinase 2 (TYK2) inhibitor. Collaboration Programs In collaboration with Zymeworks, announced positive topline results for a Phase 2b clinical trial of zanidatamab in advanced or metastatic HER2-amplified biliary tract cancers (NCT04466891); and In collaboration with Mirati, initiated patient enrollment for a Phase 2 clinical trial of sitravatinib in combination with tislelizumab in locally advanced unresectable or metastatic ESCC that progressed on or after anti-PD-(L)1 antibody therapy (NCT05461794). Manufacturing Operations Construction continues on the U.S. flagship manufacturing and clinical R&D facility at the Princeton West Innovation Campus in Hopewell, N.J. The property has more than one million square feet total of developable real estate, allowing for future expansion; Completed expansion and Good Manufacturing Practices (GMP) certification of our state-of-the-art biologics facility in Guangzhou, China, bringing total capacity to 54,000 liters with an additional expansion of 10,000 liters expected in the second quarter of 2023; and Continued construction on our new small molecule manufacturing campus in Suzhou, China. Phase 1 of construction is expected to add more than 559,000 square feet and expand production capacity to 600 million tablets/capsules, and to be completed in 2023. Once completed, qualified and approved, the total production capacity is expected to increase our small molecule manufacturing capability in China by up to 10 times current capacity. Corporate Developments Announced the launch of the Talk About It: Cancer and Mental Health program, designed to elevate the important intersection of mental health and cancer care to help improve health outcomes for cancer patients. Expected Milestones BRUKINSA Submit supplemental New Drug Applications (sNDA) in the U.S. and EU in the first half of 2023 for PFS superiority versus IMBRUVICA in R/R CLL/SLL, as demonstrated in the Phase 3 ALPINE trial; Continue to support NMPA review of sNDA for first-line CLL/SLL and WM in China, with a decision expected in the first half of 2023; Continue to support Health Canada and Australian Therapeutic Goods Administration (TGA) reviews of sNDAs for CLL, with decisions expected in 2023; and Continue to expand BRUKINSA’s registration program globally in new geographies and indications. Tislelizumab Continue to support NMPA review of BLA applications for tislelizumab in combination with chemotherapy as a first-line treatment in patients with unresectable locally advanced, recurrent or metastatic ESCC, with a decision expected in the first half of 2023; and for tislelizumab as a treatment for first-line hepatocellular carcinoma, with a decision expected in the second half of 2023; Continue to support review by regulatory authorities of BeiGene's applications for tislelizumab, including: Australia’s TGA review of BLA for tislelizumab in first- and second-line NSCLC and second-line ESCC, with a decision expected in the second half of 2023, as well as New Zealand's Medsafe review of BLA for tislelizumab in first- and second-line NSCLC and second-line ESCC; and South Korea's MFDS review of BLA for tislelizumab in second-line ESCC; In collaboration with Novartis, continue to support review of marketing applications, including: Ongoing FDA review of the BLA submission in second-line ESCC, including facilitating the scheduling of required inspections as soon as possible, with a decision expected in 2023; European Medicines Agency (EMA) review of marketing authorization applications for tislelizumab in first- and second-line NSCLC and second-line ESCC, with a decision expected in 2023; MHRA review of tislelizumab for treatment of first- and second-line NSCLC and second-line ESCC in Great Britain; Swissmedic review of marketing authorization applications for tislelizumab in second-line ESCC and second-line NSCLC; Support U.S. FDA regulatory submission by Novartis in 2023 for first-line gastric cancer and first-line unresectable ESCC; Submit BLA to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) in 2023 for first- and second-line ESCC; and Announce final analysis data from pivotal trials in extensive-stage small cell lung cancer and first-line gastric cancer in 2023. BGB-11417 (BCL-2) Initiate global pivotal trial in first-line CLL in combination with BRUKINSA in the second half of 2023; and Announce readouts from ongoing studies. Ociperlimab (TIGIT) Announce readouts for multiple Phase 2 studies in 2023, including: For second-line ESCC in patients whose tumors express PD-(L)1 (NCT04732494); For first-line HCC (NCT04948697); For first-line NSCLC (NCT05014815); and Complete enrollment in the Phase 3 AdvanTIG-302 trial in first-line NSCLC in 2023. BGB-16673 (BTK CDAC) Initial data readouts for Phase 1 studies in B cell malignancies (NCT05006716, NCT05294731) in 2023. BGB-A445 (OX 40) Initial data readout for Phase 1 study in solid tumors (NCT04215978) in 2023. BGB-15025 (HPK 1) Initiate dose expansion in combination with tislelizumab in solid tumors (NCT04649385) in 2023. Collaboration Programs In collaboration with Leads Biolabs, initiate patient dosing of LBL-007, a novel investigational antibody targeting the LAG-3 pathway, in combination with tislelizumab, in umbrella studies comparing different tislelizumab combination regimens, including with BGB-A445 and ociperlimab (NCT05635708, NCT05577702), in 2023. COVID-19 Impact and Response We expect that the worldwide health crisis of COVID-19 will continue to have a negative impact on our operations, including commercial sales, regulatory interactions, inspections, filings, manufacturing, and clinical trial recruitment, participation, and data readouts. There remains uncertainty regarding the future impact of the pandemic both globally and specifically in China due to outbreaks and restrictions and potential impact on clinical, manufacturing and commercial operations. We are striving to minimize delays and disruptions, have put protocols and procedures in place, and continue to execute on our commercial, regulatory, manufacturing, and clinical development goals globally. Financial Summary Select Condensed Consolidated Balance Sheet Data (U.S. GAAP) (Amounts in thousands of U.S. Dollars) As of December 31, December 31, 2021 1 (audited) Assets: Cash, cash equivalents, restricted cash and short-term investments 4,540,288 6,624,849 Accounts receivable 173,168 483,113 Property and equipment, net 845,946 587,605 Total assets 6,379,290 8,535,525 Liabilities and equity: Accounts payable 294,781 262,400 Accrued expenses and other payables 467,352 558,055 Deferred revenue 255,887 407,703 R&D cost share liability 293,960 390,362 538,117 629,678 Total liabilities 1,995,935 2,402,962 Total equity 4,383,355 6,132,563 Condensed Consolidated Statements of Operations (U.S. GAAP) (Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data) Three Months Ended December 31, Twelve Months Ended December 31, 2021 1 2021 1 (unaudited) (audited) Revenue: Product revenue, net 339,022 196,785 1,254,612 633,987 Collaboration revenue 41,073 17,194 161,309 542,296 Total revenues 380,095 213,979 1,415,921 1,176,283 Expenses: Cost of sales - products 73,522 48,545 286,475 164,906 Research and development 446,023 430,485 1,640,508 1,459,239 Selling, general and administrative 328,984 306,501 1,277,852 990,123 Amortization of intangible assets Total expenses 848,717 785,718 3,205,586 2,615,018 Loss from operations (468,622 (571,739 (1,789,665 (1,438,735 Interest (expense) income, net 18,219 (4,482 52,480 (15,757 Other (expense) income, net 19,438 (10,583 (223,852 15,904 Loss before income taxes (430,965 (586,804 (1,961,037 (1,438,588 Income tax expense 14,370 3,874 42,778 19,228 Net loss (445,335 (590,678 (2,003,815 (1,457,816 Less: Net loss attributable to noncontrolling interest Net loss attributable to BeiGene, Ltd. (445,335 (590,678 (2,003,815 (1,457,816 Net loss per share attributable to BeiGene, Ltd., basic and diluted (0.33 (0.48 (1.49 (1.21 Weighted-average shares outstanding, basic and diluted 1,348,916,108 1,235,346,414 1,340,729,572 1,206,210,049 Net loss per ADS attributable to BeiGene, Ltd., basic and diluted (4.29 (6.22 (19.43 (15.71 Weighted-average ADSs outstanding, basic and diluted 103,762,778 95,026,647 103,133,044 92,785,388 [1] We revised certain prior period financial statements for an error related to the valuation of net deferred tax assets, the impact of which was immaterial to our previously filed financial statements in the first and second quarter of 2022 and the quarterly and annual periods of fiscal 2021 (see "Notes to the Consolidated Financial Statements, Note. 2 Summary of Significant Accounting Policies" and "Note 3. Revision of Prior Period Financial Statements" included in our Annual Report on Form 10-K for the fiscal year ended 2022). BeiGene is a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 9,000 colleagues spans five continents, with administrative offices in Basel; Beijing; and Cambridge, U.S. To learn more about BeiGene, please visit and follow us on Twitter at @BeiGeneGlobal. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding clinical data for BeiGene’s drug candidates and approvals of its medicines; the conduct of late-stage clinical trials and expected data readouts; additional planned product approvals and launches; the advancement of and anticipated clinical development, regulatory approvals and other milestones and commercialization of BeiGene’s medicines and drug candidates; the potential for BRUKINSA to provide clinical benefit to patients with CLL compared with the comparator drug; the success of BeiGene’s commercialization efforts and revenue growth; the expected capacities and completion dates for the Company's manufacturing facilities under construction; the impact of the COVID-19 pandemic on the Company’s clinical development, regulatory, commercial, manufacturing, and other operations; BeiGene’s plans and the expected events and milestones under the captions “Recent Business Highlights” and “Expected Milestones”; and BeiGene's plans, commitments, aspirations and goals under the caption “About BeiGene”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercial, manufacturing, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law. BLINCYTO®, KYPROLIS® and XGEVA® are registered trademarks of Amgen. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. IMBRUVICA® is a registered trademark of Pharmacyclics LLC and Janssen Biotech, Inc.

Nov. 4, 2021 20:05 UTC Recorded product revenue of $192.5 million for the third quarter, representing a 111% increase from $91.1 million in the prior year period Received approvals for BRUKINSA® in two new indications in the U.S. and approvals in six other markets Submitted first biologics license application (BLA) in the U.S. for tislelizumab in collaboration with Novartis for patients with advanced or metastatic esophageal squamous cell carcinoma following prior systemic therapy CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)-- BeiGene Co.,Ltd (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today reported recent business highlights, anticipated upcoming milestones, and financial results for the third quarter and nine months ended September 30, 2021. “We remain focused on translating science into highly impactful medicines and making these medicines more affordable and accessible to many more people with cancer around the world,” said John V. Oyler, Co-Founder, Chairman and Chief Executive Officer of BeiGene. “In the third quarter we had two new indications approved for BRUKINSA in the United States, and recent BRUKINSA approvals in Australia, Singapore, Brazil, Russia, and Chile as well as a positive CHMP opinion for our first BRUKINSA filing in Europe. Tislelizumab’s BLA for esophageal squamous cell carcinoma (ESCC) has been accepted for review by the FDA, which is the first filing for our internally developed anti-PD-1 medicine outside of China and an important achievement in our collaboration with Novartis. This is one of many global tislelizumab studies that comprise a comprehensive PD-1 program that has enrolled over 5,600 patients in more than 30 countries and regions and includes over 1,700 patients from outside of China. We also continued to expand and strengthen our strategic competitive advantages that we feel are critical to transform the industry and bring innovative and accessible medicines to billions more people around the world. These include research, predominantly CRO-free global clinical development, global commercial infrastructure, and internal manufacturing capabilities.” Recent Business Highlights and Upcoming Milestones Commercial Operations Product sales increased 111% in the third quarter of 2021 compared to the prior year period, primarily due to increased sales of our internally developed products and in-licensed products from Amgen; Global sales of BRUKINSA totaled $65.8 million in the third quarter, representing a 320% increase compared to the prior year period; U.S. sales of BRUKINSA totaled $33.7 million in the third quarter compared to $5.7 million in the comparable prior year period. U.S. sales continued to accelerate in the quarter, driven by continued uptake in mantle cell lymphoma (MCL) and the recent FDA approvals in Waldenström’s macroglobulinemia (WM) and marginal zone lymphoma (MZL). BRUKINSA sales in China totaled $32.1 million in the third quarter, representing growth of 223% compared to the prior year period, driven by a significant increase in all approved indications, including chronic lymphocytic leukemia (CLL); Sales of tislelizumab in China totaled $77.0 million in the third quarter, representing a 54% increase compared to the prior year period. In the third quarter, new patient demand from broader reimbursement and further expansion of our salesforce and hospital listings continued to drive increased market penetration and market share for tislelizumab; The commercial organization in China continued to demonstrate its ability to bring new products to market, launching the second product from the Amgen collaboration, BLINCYTO® (blinatumomab), which contributed $5.0 million of sales in the third quarter. Two additional new products are expected to be approved or launched by the end of the year; and We are preparing for the upcoming National Reimbursement Drug List (NRDL) negotiation in China for our eligible medicines, including tislelizumab in first-line non-squamous non-small cell lung cancer (NSCLC), first-line squamous NSCLC and second- or third-line hepatocellular carcinoma (HCC), BRUKINSA in WM, and pamiparib in germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy. The NRDL negotiations are anticipated to be completed in the fourth quarter of 2021. Development Programs BRUKINSA® (zanubrutinib), a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects, approved in the U.S., China, Canada, Australia, and other international markets in selected indications and under development for additional approvals globally. Received FDA approvals in two new indications, including full approval for the treatment of adult patients with WM, and accelerated approval for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen; Received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval for the treatment of adult patients with WM who have received at least one prior therapy or first-line treatment for patients unsuitable for chemo-immunotherapy; Was granted a cohort Temporary Authorization for Use (cATU), an early access program, for patients with WM by the French National Agency for Medicines and Health Products Safety (ANSM); Received acceptance of the marketing authorization application (MAA) from Swissmedic and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for patients with WM; Received approval in Australia for the treatment of adult patients with MCL who have received at least one prior therapy and for patients with WM who have received at least one prior therapy or in first line treatment for patients unsuitable for chemo-immunotherapy; and Continued to advance BRUKINSA in new markets. BRUKINSA is now approved in Australia, Russia, Singapore, Brazil, Chile, Israel, and UAE for patients with MCL who have received at least one prior therapy. There currently are more than 20 marketing authorization applications in multiple indications under review around the world. Expected Milestones for BRUKINSA Receive EMA approval for treating adult patients with WM who have received at least one prior therapy or first-line treatment for patients unsuitable for chemo-immunotherapy in 2021; Report results from the Phase 3 SEQUOIA trial (NCT03336333) comparing BRUKINSA with bendamustine plus rituximab in patients with treatment-naïve CLL or small lymphocytic lymphoma (SLL); and early results from Arm D in patients with del(17p) in combination with venetoclax in two oral presentations at the 63rd American Society of Hematology (ASH) Annual Meeting taking place December 11-14, 2021; Continue to discuss Phase 3 clinical trial results in CLL with regulatory agencies in the U.S., Europe, and other countries; Report additional results from the Phase 3 ALPINE trial (NCT03734016) in 2022; and Continue to expand BRUKINSA’s registration program globally in new geographies and indications, including potential additional approvals in 2021 and the first half of 2022 for certain patients with MCL in APAC, the Middle East and South America. Tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages; approved in China in selected indications and under development for additional approvals globally. Received acceptance by the FDA of a BLA for tislelizumab in collaboration with Novartis as a treatment for patients with unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy. The Prescription Drug User Fee Act (PDUFA) target action date is July 12, 2022; Received acceptance by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) of a supplemental BLA (sBLA) in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC); Received approval from the NMPA in a new indication, for front-line squamous NSCLC with nab-paclitaxel and carboplatin; and Reported data at the European Society for Medical Oncology (ESMO) Congress 2021 including: – RATIONALE 304 (NCT03663205): Tislelizumab plus chemotherapy vs. chemotherapy alone as first-line treatment for non-squamous NSCLC in patients who are smokers vs. non-smokers; and – RATIONALE 307 (NCT03594747): Tislelizumab plus chemotherapy vs. chemotherapy alone as first-line treatment for advanced squamous NSCLC in patients who were smokers vs. non-smokers. Expected Milestones for Tislelizumab Receive approvals in China for the four sBLAs currently under review in first-line NPC, second- or third-line NSCLC, second-line ESCC, and second- or third-line MSI-High solid tumors in 2022. Pamiparib, a selective small molecule inhibitor of PARP1 and PARP2 conditionally approved in China for the treatment of patients with germline BRCA mutation-associated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy. Expected Milestones for Pamiparib Report topline results from the Phase 3 trial (NCT03519230) of pamiparib as a maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer, in 2021 or the first half of 2022. Ociperlimab (BGB-A1217), an investigational anti-TIGIT monoclonal antibody with competent Fc function Initiated patient enrollment in the Phase 2 AdvanTIG-206 trial (NCT04948697) of ociperlimab in combination with tislelizumab plus Bio-Thera’s POBEVCY® (BAT1706), a biosimilar to bevacizumab (Avastin®), as first-line treatment in patients with advanced HCC. Expected Milestones for ociperlimab Initiate patient enrollment in the global Phase 2 AdvanTIG-205 trial (NCT05014815) in frontline stage IV NSCLC, in 2021. BGB-11417, an investigational BCL-2 inhibitor Initiated patient enrollment in a Phase 1 trial (NCT04973605) in patients with multiple myeloma with t (11;14) translocation, in 2021. Expected Milestones for BGB-11417 Begin patient enrollment in pivotal trials, in 2022. Early-Stage Programs Continued to advance our early-stage clinical pipeline of internally-developed product candidates at dose escalation stage, including BGB-A445 (an investigational non-ligand competing OX40 monoclonal antibody as monotherapy or in combination with tislelizumab in solid tumors), BGB-15025 (an investigational hematopoietic progenitor kinase 1 (HPK1) inhibitor as monotherapy or in combination with tislelizumab in solid tumors), BGB-10188 (an investigational PI3Kδ inhibitor as monotherapy or in combination with BRUKINSA in hematology malignancies, or in combination with tislelizumab in solid tumors); BGB-16673 (an investigational Chimeric Degradation Activating Compound, or CDAC, targeting BTK) received investigational new drug (IND) clearance and permission to proceed from the FDA. Patient dosing in the first Phase 1 trial (NCT05006716) in patients with B-cell malignancies is expected to begin in 2021; and BGB-A425 (an investigational TIM3 monoclonal antibody) study advanced to the Phase 2 portion of the Phase 1/2 trial (NCT03744468) in combination with tislelizumab. Collaboration with Amgen Secured approval by the Hainan BoAo government for early access to LUMAKRAS® (sotorasib, a KRAS G12C inhibitor) in designated hospitals in the province. Other Collaboration Programs Announced that the NMPA granted QARZIBA® (dinutuximab beta) conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of R/R neuroblastoma with or without residual disease. QARZIBA is a targeted immunotherapy licensed by EUSA Pharma to BeiGene in mainland China; Received notification by BMS-Celgene of its intent to terminate a license and supply agreement with respect to ABRAXANE® (nanoparticle albumin-bound paclitaxel) in China. BeiGene contests this action, as it believes that the reasons provided by BMS-Celgene are not valid bases for terminating the agreement with respect to ABRAXANE. Arbitration proceedings are ongoing between the parties regarding BMS-Celgene’s failure to ensure the continuity and adequacy of its supply of ABRAXANE under the agreement in accordance with Good Manufacturing Practices (GMP); and Received results from the Phase 2 trial (NCT04551898) evaluating investigational SARS-CoV-2 neutralizing antibody BGB-DXP593 in patients with mild to moderate COVID-19, licensed from Singlomics outside of China. The trial did not meet the primary efficacy endpoint of viral load change in nasopharyngeal swabs at Day 8. The license rights of the two Singlomics candidates (DXP593 and DXP604) outside of the U.S. and the development rights of the candidates in the U.S. have been returned to Singlomics under a reversion agreement signed by the parties, with BeiGene retaining U.S. commercial rights. Sitravatinib, an investigational tyrosine kinase inhibitor of receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET, licensed from Mirati Therapeutics Inc. (Mirati), in Asia (excluding Japan), Australia, and New Zealand. Reported data at the European Society for Medical Oncology (ESMO) Congress 2021: − Sitravatinib + tislelizumab in patients with anti-PD-(L)1 refractory/resistant metastatic NSCLC (NCT03666143); and − Sitravatinib + tislelizumab in patients with metastatic NSCLC (NCT03666143). Zanidatamab, (ZW25) an investigational bispecific HER2 antibody targeting HER2 in late-stage clinical development with Zymeworks, Inc. Expected Milestones for Zanidatamab Initiate a Phase 3 clinical trial in first-line HER2+ gastric cancer, in 2021. Manufacturing Operations Continued efforts to secure geographically diverse manufacturing and supply chain redundancy with the previously announced plans to build a new commercial-stage manufacturing and clinical R&D campus at Princeton West Innovation Park in Hopewell, New Jersey. The acquisition of the property is expected to close in 2021; Continued construction on the new small molecule manufacturing campus in Suzhou, China. Phase 1 of construction will bring over 50,000 square meters and 600M solid preparation capacity and is expected to be completed in 2023. Once completed, the total production capacity is expected to increase BeiGene's small molecule manufacturing capability in China by up to six times the current capacity; and Two additional 2,000L bioreactors at Boehringer Ingelheim’s facility are available to support commercial production of tislelizumab’s expanding indications in China. This is in addition to BeiGene’s state-of-the-art biologics facility in Guangzhou, China, which currently is approved for 8,000 liters of biologics capacity with an additional phase of construction expected to bring total capacity to 64,000 liters, and to be completed by the end of 2022. COVID-19 Impact and Response The Company expects that the worldwide health crisis of COVID-19 will continue to have a negative impact on its operations, including commercial sales, regulatory interactions, inspections, filings, and clinical trial recruitment, participation, and data read outs. There remains uncertainty regarding the future impact of the pandemic globally. The Company is striving to minimize delays and disruptions, and continues to execute on its commercial, regulatory, manufacturing, and clinical development goals globally. Corporate Developments Listing of the Company’s ordinary shares on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange is expected to be completed in 2021, subject to market conditions and additional regulatory approvals; and Received inclusion in several FTSE Russell indices, including: the FTSE Global Equity Index Large Cap; the FTSE All-World (LM); the FTSE All-Cap (LMS); and the FTSE Total-Cap (LMSµ). In addition, BeiGene was included in the FTSE Developed ESG Low Carbon Select Index, and the FTSE Asia ex Japan ESG Low Carbon Select Index, reflecting the Company’s commitment to sustainability. Third Quarter 2021 Financial Results Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments were $3.9 billion as of September 30, 2021, compared to $4.4 billion as of June 30, 2021, and $4.7 billion as of December 31, 2020. In the three months ended September 30, 2021, cash used in operating activities was $495.7 million, primarily due to our net loss of $413.9 million and a $89.4 million increase in our net operating assets and liabilities, offset by non-cash charges of $7.5 million; capital expenditures were $67.0 million; and cash provided by financing activities was $109.2 million, consisting primarily of $50 million in proceeds from the sale of shares to Amgen, as well as the exercise of employee share options. Revenue for the three months ended September 30, 2021 was $206.4 million, compared to $91.1 million in the same period of 2020. Product revenue totaled $192.5 million for the three months ended September 30, 2021, compared to $91.1 million in the same period of 2020, including: – Sales of tislelizumab in China of $77.0 million, compared to $49.9 million in the prior year period; – Sales of BRUKINSA of $65.8 million, compared to $15.7 million in the prior year period; – Sales of XGEVA® (denosumab), the first product transferred to BeiGene from the Amgen collaboration, in China of $15.7 million, compared to $3.1 million in the prior year period. BeiGene commenced sales and marketing in China in July 2020; Collaboration revenue for the three months ended September 30, 2021 was $14.0 million, resulting from the partial recognition of previously deferred revenue associated with the upfront payment received from Novartis in the first quarter of 2021. There was no collaboration revenue in the prior year period. Expenses for the three months ended September 30, 2021 were $668.8 million, compared to $531.2 million in the same period of 2020. Cost of Sales for the three months ended September 30, 2021 were $47.4 million, compared to $21.1 million in the same period of 2020. Cost of sales increased primarily due to increased product sales of tislelizumab, BRUKINSA, and XGEVA. R&D Expenses for the three months ended September 30, 2021 were $351.9 million, compared to $349.1 million in the same period of 2020. The increase in R&D expenses was primarily attributable to increases in headcount and external costs related to our investment in discovery and development activities, including our continued efforts to internalize research and clinical trial activities, partially offset by decreased spending on clinical trials related to BRUKINSA, as well as decreased expense related to upfront fees related to in-process R&D. Additionally, R&D-related share-based compensation expense was $31.7 million for the three months ended September 30, 2021, compared to $25.4 million for the same period of 2020. SG&A Expenses for the three months ended September 30, 2021 were $269.2 million, compared to $160.8 million in the same period of 2020. The increase in SG&A expenses was primarily attributable to increased headcount and increased external expenses related to the growth of our global commercial organization, as we continued to build our worldwide footprint. SG&A-related share-based compensation expense was $35.4 million for the three months ended September 30, 2021, compared to $24.9 million for the same period of 2020. Net Loss for the three months ended September 30, 2021 was $413.9 million, or $0.34 per share, and $4.46 per American Depositary Share (ADS), compared to $425.2 million, or $0.37 per share, and $4.81 per ADS in the same period of 2020. Financial Summary Select Condensed Consolidated Balance Sheet Data (U.S. GAAP) (Amounts in thousands of U.S. Dollars) As of September 30, December 31, (unaudited) (audited) Assets: Cash, cash equivalents, restricted cash and short-term investments 3,923,313 4,658,730 Accounts receivable, net 129,584 60,403 Working capital 3,128,400 3,885,491 Property and equipment, net 450,788 357,686 Total assets 5,286,334 5,600,757 Liabilities and equity: Accounts payable 206,203 231,957 Accrued expenses and other payables 389,874 346,144 Deferred revenue 124,898 R&D cost share liability 420,001 502,848 643,278 518,652 Total liabilities 1,929,261 1,731,514 Total equity 3,357,073 3,869,243 Condensed Consolidated Statements of Operations (U.S. GAAP) (Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data) Three Months Ended September 30, Nine Months Ended September 30, (Unaudited) (Unaudited) Revenue: Product revenue, net 192,461 91,080 437,202 208,774 Collaboration revenue 13,979 525,102 Total revenues 206,440 91,080 962,304 208,774 Expenses: Cost of sales - products 47,413 21,123 116,361 49,579 Research and development [1] 351,937 349,070 1,028,754 939,340 Selling, general and administrative 269,227 160,837 683,622 391,967 Amortization of intangible assets Total expenses 668,765 531,217 1,829,300 1,381,544 Loss from operations (462,325) (440,137) (866,996) (1,172,770) Interest (expense) income, net (2,230) (614) (11,275) 7,184 Other income, net 31,477 5,711 26,487 29,368 Loss before income taxes (433,078) (435,040) (851,784) (1,136,218) Income tax benefit (19,223) (8,423) (24,083) (8,344) Net loss (413,855) (426,617) (827,701) (1,127,874) Less: Net loss attributable to noncontrolling interest (1,393) (3,713) Net loss attributable to BeiGene, Ltd. (413,855) (425,224) (827,701) (1,124,161) Net loss per share attributable to BeiGene, Ltd.: Basic and diluted (0.34) (0.37) (0.69) (1.07) Weighted-average shares outstanding: Basic and diluted 1,205,971,284 1,148,973,077 1,196,391,201 1,052,940,583 Net loss per ADS attributable to BeiGene, Ltd. Basic and diluted (4.46) (4.81) (8.99) (13.88) Weighted-average ADSs outstanding: Basic and diluted 92,767,022 88,382,544 92,030,092 80,995,429 [1] Research and development expense for the three and nine months ended September 30, 2021 includes upfront fees related to in-process research and development of in-licensed assets totaling nil and $53.5 million, respectively, compared to $66.5 million and $109.5 million in the comparable prior year periods. About BeiGene