Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2022 | Oct. 31, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-37686 | |
Entity Registrant Name | BEIGENE, LTD. | |
Entity Incorporation, State or Country Code | E9 | |
Entity Tax Identification Number | 98-1209416 | |
Entity Address, Street Address | c/o Mourant Governance Services (Cayman) Limited | |
Entity Address, Street Address Two | 94 Solaris Avenue, Camana Bay | |
Entity Address, City | Grand Cayman | |
Entity Address, Country | KY | |
Entity Address, Postal Zip Code | KY1-1108 | |
City Area Code | 345 | |
Local Phone Number | 949-4123 | |
Title of each class | American Depositary Shares, each representing 13 Ordinary Shares, par value $0.0001 per share | |
Trading Symbol(s) | BGNE | |
Name of each exchange on which registered | NASDAQ | |
Entity Common Stock, Shares Outstanding | 1,349,640,180 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0001651308 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS ¥ in Thousands, $ in Thousands | Sep. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) |
Current assets: | ||
Cash and cash equivalents | $ 4,197,132 | $ 4,375,678 |
Short-term restricted cash | 191 | 328 |
Short-term investments | 871,998 | 2,241,962 |
Accounts receivable, net | 189,170 | 483,113 |
Inventories | 290,911 | 242,626 |
Prepaid expenses and other current assets | 199,766 | 270,173 |
Total current assets | 5,749,168 | 7,613,880 |
Long-term restricted cash | 3,189 | 6,881 |
Property, plant and equipment, net | 681,914 | 587,605 |
Operating lease right-of-use assets | 110,340 | 117,431 |
Intangible assets, net | 40,849 | 46,679 |
Deferred tax assets | 0 | 0 |
Other non-current assets | 140,553 | 163,049 |
Total non-current assets | 976,845 | 921,645 |
Total assets | 6,726,013 | 8,535,525 |
Current liabilities: | ||
Accounts payable | 252,071 | 262,400 |
Accrued expenses and other payables | 410,255 | 558,055 |
Deferred revenue, current portion | 144,984 | 187,414 |
Tax payable | 22,665 | 21,395 |
Operating lease liabilities, current portion | 24,340 | 21,925 |
Research and development cost share liability, current portion | 115,721 | 120,801 |
Short-term debt | 441,275 | 427,565 |
Total current liabilities | 1,411,311 | 1,599,555 |
Non-current liabilities: | ||
Long-term bank loans | 208,058 | 202,113 |
Deferred revenue, non-current portion | 149,899 | 220,289 |
Operating lease liabilities, non-current portion | 36,904 | 43,041 |
Deferred tax liabilities | 15,249 | 14,169 |
Research and development cost share liability, non-current portion | 204,252 | 269,561 |
Other long-term liabilities | 45,169 | 54,234 |
Total non-current liabilities | 659,531 | 803,407 |
Total liabilities | 2,070,842 | 2,402,962 |
Commitments and contingencies | ||
Equity: | ||
Ordinary shares, US$0.0001 par value per share; 9,500,000,000 shares authorized; 1,349,640,180 and 1,334,804,281 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 135 | 133 |
Additional paid-in capital | 11,451,566 | 11,191,007 |
Accumulated other comprehensive (loss) income | (161,523) | 17,950 |
Accumulated deficit | (6,635,007) | (5,076,527) |
Total equity | 4,655,171 | 6,132,563 |
Total liabilities and equity | $ 6,726,013 | $ 8,535,525 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Ordinary shares | ||
Ordinary shares, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Ordinary shares, shares authorized (in shares) | 9,500,000,000 | 9,500,000,000 |
Ordinary shares, shares issued (in shares) | 1,349,640,180 | 1,334,804,281 |
Ordinary shares, shares outstanding (in shares) | 1,349,640,180 | 1,334,804,281 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues | ||||
Total revenues | $ 387,628 | $ 206,440 | $ 1,035,826 | $ 962,304 |
Expenses | ||||
Cost of sales - product | 76,543 | 47,413 | 212,953 | 116,361 |
Research and development | 426,363 | 351,937 | 1,194,485 | 1,028,754 |
Selling, general and administrative | 322,892 | 269,227 | 948,868 | 683,622 |
Amortization of intangible assets | 187 | 188 | 563 | 563 |
Total expenses | 825,985 | 668,765 | 2,356,869 | 1,829,300 |
Loss from operations | (438,357) | (462,325) | (1,321,043) | (866,996) |
Interest income (expense), net | 12,759 | (2,230) | 34,261 | (11,275) |
Other (expense) income, net | (125,640) | 31,477 | (243,290) | 26,487 |
Loss before income taxes | (551,238) | (433,078) | (1,530,072) | (851,784) |
Income tax expense | 6,318 | 5,036 | 28,408 | 15,354 |
Net loss | $ (557,556) | $ (438,114) | $ (1,558,480) | $ (867,138) |
Net loss per share, basic (in dollars per share) | $ (0.41) | $ (0.36) | $ (1.16) | $ (0.72) |
Net loss per share, diluted (in dollars per share) | $ (0.41) | $ (0.36) | $ (1.16) | $ (0.72) |
Weighted average shares outstanding—basic (in shares) | 1,345,303,747 | 1,205,971,284 | 1,337,976,853 | 1,196,391,201 |
Weighted average shares outstanding - diluted (in shares) | 1,345,303,747 | 1,205,971,284 | 1,337,976,853 | 1,196,391,201 |
Net loss per American Depositary Share ("ADS") basic (in dollars per share) | $ (5.39) | $ (4.72) | $ (15.14) | $ (9.42) |
Net loss per American Depositary Share ("ADS") diluted (in dollars per share) | $ (5.39) | $ (4.72) | $ (15.14) | $ (9.42) |
Weighted-average ADSs outstanding - basic (in shares) | 103,484,904 | 92,767,022 | 102,921,296 | 92,030,092 |
Weighted-average ADSs outstanding - diluted (in shares) | 103,484,904 | 92,767,022 | 102,921,296 | 92,030,092 |
Product revenue, net | ||||
Revenues | ||||
Total revenues | $ 349,506 | $ 192,461 | $ 915,590 | $ 437,202 |
Collaboration revenue | ||||
Revenues | ||||
Total revenues | $ 38,122 | $ 13,979 | $ 120,236 | $ 525,102 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||
Net loss | $ (557,556) | $ (438,114) | $ (1,558,480) | $ (867,138) |
Other comprehensive income (loss), net of tax of nil: | ||||
Foreign currency translation adjustments | (80,326) | 664 | (168,411) | 6,528 |
Pension liability adjustments | 0 | (111) | 0 | 250 |
Unrealized holding loss, net | 1,253 | (68) | (11,062) | (1,140) |
Comprehensive loss | $ (636,629) | $ (437,629) | $ (1,737,953) | $ (861,500) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Operating activities: | |||||
Net loss | $ (557,556) | $ (438,114) | $ (1,558,480) | $ (867,138) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||
Depreciation and amortization expense | 48,262 | 33,336 | |||
Share-based compensation expenses | 225,036 | 177,701 | |||
Unrealized losses (gains) on equity investments | 16,413 | (17,166) | |||
Acquired in-process research and development | 20,000 | 53,500 | |||
Amortization of research and development cost share liability | (70,389) | (82,846) | |||
Deferred income tax benefits | 380 | 2,474 | |||
Other items, net | 7,762 | 17,719 | |||
Changes in operating assets and liabilities: | |||||
Accounts receivable | 284,717 | (69,174) | |||
Inventories | (75,632) | (61,686) | |||
Other assets | 30,325 | (92,489) | |||
Accounts payable | 4,203 | (12,376) | |||
Accrued expenses and other payables | 1,628 | (44) | |||
Deferred revenue | (112,820) | 124,898 | |||
Other liabilities | 167 | 2,407 | |||
Net cash used in operating activities | (1,178,428) | (790,884) | |||
Investing activities: | |||||
Purchases of property, plant and equipment | (204,076) | (147,963) | |||
Purchases of investments | (14,735) | (2,062,879) | |||
Proceeds from sale or maturity of investments | 1,352,398 | 2,758,391 | |||
Purchase of in-process research and development | (95,000) | (8,500) | |||
Other investing activities | 0 | (7,500) | |||
Net cash provided by investing activities | 1,038,587 | 531,549 | |||
Financing activities: | |||||
Proceeds from sale of ordinary shares, net of cost | 0 | 50,000 | |||
Proceeds from long-term loan | 37,372 | 16,838 | |||
Proceeds from short-term loans | 163,774 | 143,456 | |||
Repayment of short-term loans | (145,428) | (40,229) | |||
Proceeds from option exercises and employee share purchase plan | 35,677 | 82,192 | |||
Net cash provided by financing activities | 91,395 | 252,257 | |||
Effect of foreign exchange rate changes, net | (133,929) | 6,769 | |||
Net decrease in cash, cash equivalents, and restricted cash | (182,375) | (309) | |||
Cash, cash equivalents, and restricted cash at beginning of period | 4,382,887 | 1,390,005 | $ 1,390,005 | ||
Cash, cash equivalents, and restricted cash at end of period | 4,200,512 | 1,389,696 | 4,200,512 | 1,389,696 | 4,382,887 |
Supplemental cash flow information: | |||||
Cash and cash equivalents | 4,197,132 | 1,383,310 | 4,197,132 | 1,383,310 | 4,375,678 |
Short-term restricted cash | 191 | 330 | 191 | 330 | 328 |
Long-term restricted cash | $ 3,189 | $ 6,056 | 3,189 | 6,056 | $ 6,881 |
Income taxes paid | 25,006 | 15,214 | |||
Interest paid | 19,865 | 23,398 | |||
Supplemental non-cash information: | |||||
Acquisitions of equipment included in accounts payable | 47,310 | 41,897 | |||
Acquired in-process research and development included in accrued expenses | $ 0 | $ 45,000 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY - USD ($) $ in Thousands | Total | Ordinary Shares | Additional Paid-In Capital | Accumulated Other Comprehensive Income (loss) | Accumulated Deficit |
Balance at the beginning of period at Dec. 31, 2020 | $ 3,803,281 | $ 118 | $ 7,414,932 | $ 6,942 | $ (3,618,711) |
Balance at the beginning of period (in shares) at Dec. 31, 2020 | 1,190,821,941 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Use of shares reserved for share option exercises and RSU releases (in shares) | (123,097) | ||||
Exercise of options, ESPP and release of RSUs | 25,754 | $ 1 | 25,753 | ||
Exercise of options, ESPP and release of RSUs (in shares) | 6,623,773 | ||||
Share-based compensation | 45,833 | 45,833 | |||
Other comprehensive income (loss) | (3,738) | (3,738) | |||
Net income (loss) | 55,580 | 55,580 | |||
Balance at the end of period at Mar. 31, 2021 | 3,926,710 | $ 119 | 7,486,518 | 3,204 | (3,563,131) |
Balance at the end of period (in shares) at Mar. 31, 2021 | 1,197,322,617 | ||||
Balance at the beginning of period at Dec. 31, 2020 | 3,803,281 | $ 118 | 7,414,932 | 6,942 | (3,618,711) |
Balance at the beginning of period (in shares) at Dec. 31, 2020 | 1,190,821,941 | ||||
Balance at the end of period at Dec. 31, 2021 | $ 6,132,563 | $ 133 | 11,191,007 | 17,950 | (5,076,527) |
Balance at the end of period (in shares) at Dec. 31, 2021 | 1,334,804,281 | 1,334,804,281 | |||
Balance at the beginning of period at Mar. 31, 2021 | $ 3,926,710 | $ 119 | 7,486,518 | 3,204 | (3,563,131) |
Balance at the beginning of period (in shares) at Mar. 31, 2021 | 1,197,322,617 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Use of shares reserved for share option exercises and RSU releases (in shares) | (1,599,676) | ||||
Exercise of options, ESPP and release of RSUs | 9,847 | $ 1 | 9,846 | ||
Exercise of options, ESPP and release of RSUs (in shares) | 8,844,082 | ||||
Share-based compensation | 64,791 | 64,791 | |||
Other comprehensive income (loss) | 8,891 | 8,891 | |||
Net income (loss) | (484,604) | (484,604) | |||
Balance at the end of period at Jun. 30, 2021 | 3,525,635 | $ 120 | 7,561,155 | 12,095 | (4,047,735) |
Balance at the end of period (in shares) at Jun. 30, 2021 | 1,204,567,023 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Proceeds from issuance of ordinary shares, net of cost (in shares) | 2,151,877 | ||||
Proceeds from issuance of ordinary shares, net of cost | 50,000 | $ 0 | 50,000 | ||
Use of shares reserved for share option exercises and RSU releases (in shares) | (3,644,641) | ||||
Exercise of options, ESPP and release of RSUs | 46,591 | $ 1 | 46,590 | ||
Exercise of options, ESPP and release of RSUs (in shares) | 10,159,942 | ||||
Share-based compensation | 67,077 | 67,077 | |||
Other comprehensive income (loss) | 485 | 485 | |||
Net income (loss) | (438,114) | (438,114) | |||
Balance at the end of period at Sep. 30, 2021 | 3,251,674 | $ 121 | 7,724,822 | 12,580 | (4,485,849) |
Balance at the end of period (in shares) at Sep. 30, 2021 | 1,213,234,201 | ||||
Balance at the beginning of period at Dec. 31, 2021 | $ 6,132,563 | $ 133 | 11,191,007 | 17,950 | (5,076,527) |
Balance at the beginning of period (in shares) at Dec. 31, 2021 | 1,334,804,281 | 1,334,804,281 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Cost from issuance of ordinary shares | $ (152) | (152) | |||
Use of shares reserved for share option exercises and RSU releases (in shares) | (2,850,328) | ||||
Exercise of options, ESPP and release of RSUs | 11,880 | 11,880 | |||
Exercise of options, ESPP and release of RSUs (in shares) | 2,851,316 | ||||
Share-based compensation | 65,555 | 65,555 | |||
Other comprehensive income (loss) | (496) | (496) | |||
Net income (loss) | (435,198) | (435,198) | |||
Balance at the end of period at Mar. 31, 2022 | 5,774,152 | $ 133 | 11,268,290 | 17,454 | (5,511,725) |
Balance at the end of period (in shares) at Mar. 31, 2022 | 1,334,805,269 | ||||
Balance at the beginning of period at Dec. 31, 2021 | $ 6,132,563 | $ 133 | 11,191,007 | 17,950 | (5,076,527) |
Balance at the beginning of period (in shares) at Dec. 31, 2021 | 1,334,804,281 | 1,334,804,281 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Other comprehensive income (loss) | $ (179,473) | ||||
Balance at the end of period at Sep. 30, 2022 | $ 4,655,171 | $ 135 | 11,451,566 | (161,523) | (6,635,007) |
Balance at the end of period (in shares) at Sep. 30, 2022 | 1,349,640,180 | 1,349,640,180 | |||
Balance at the beginning of period at Mar. 31, 2022 | $ 5,774,152 | $ 133 | 11,268,290 | 17,454 | (5,511,725) |
Balance at the beginning of period (in shares) at Mar. 31, 2022 | 1,334,805,269 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Use of shares reserved for share option exercises and RSU releases (in shares) | 5,016,518 | ||||
Exercise of options, ESPP and release of RSUs | 7,092 | $ 1 | 7,091 | ||
Exercise of options, ESPP and release of RSUs (in shares) | 9,817,938 | ||||
Share-based compensation | 81,305 | 81,305 | |||
Other comprehensive income (loss) | (99,904) | (99,904) | |||
Net income (loss) | (565,726) | (565,726) | |||
Balance at the end of period at Jun. 30, 2022 | 5,196,919 | $ 134 | 11,356,686 | (82,450) | (6,077,451) |
Balance at the end of period (in shares) at Jun. 30, 2022 | 1,349,639,725 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Use of shares reserved for share option exercises and RSU releases (in shares) | (3,971,942) | ||||
Exercise of options, ESPP and release of RSUs | 16,705 | $ 1 | 16,704 | ||
Exercise of options, ESPP and release of RSUs (in shares) | 3,972,397 | ||||
Share-based compensation | 78,176 | 78,176 | |||
Other comprehensive income (loss) | (79,073) | (79,073) | |||
Net income (loss) | (557,556) | (557,556) | |||
Balance at the end of period at Sep. 30, 2022 | $ 4,655,171 | $ 135 | $ 11,451,566 | $ (161,523) | $ (6,635,007) |
Balance at the end of period (in shares) at Sep. 30, 2022 | 1,349,640,180 | 1,349,640,180 |
Description of Business, Basis
Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies | Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies Description of business BeiGene, Ltd. (the "Company", "BeiGene", "it", "its") is a global biotechnology company focused on developing and commercializing innovative affordable oncology medicines to improve treatment outcomes and expand access for patients worldwide. The Company currently has three approved medicines that were discovered and developed in its own labs, including BRUKINSA ® , a small molecule inhibitor of Bruton’s Tyrosine Kinase (BTK) for the treatment of various blood cancers, tislelizumab, an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers, and pamiparib, a selective small molecule inhibitor of PARP1 and PARP2. The Company has obtained approvals to market BRUKINSA ® in the United States, the People's Republic of China (China or the PRC), the European Union (EU), the United Kingdom ("UK"), Canada, Australia and additional international markets, and tislelizumab and pamiparib in China. By leveraging its China commercial capabilities, the Company has in-licensed the rights to distribute 13 approved medicines for the China market. Supported by its global clinical development and commercial capabilities, the Company has entered into collaborations with world-leading biopharmaceutical companies such as Amgen Inc. ("Amgen") and Novartis Pharma AG ("Novartis") to develop and commercialize innovative medicines. The Company is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. Its internal clinical development capabilities are deep, including a more than 2,500-person global clinical development and medical affairs team that is running close to 80 ongoing or planned clinical trials in over 40 medicines and drug candidates. This includes more than 30 pivotal or potentially registration-enabling trials across its portfolio, including three internally discovered, approved medicines. The Company has enrolled in its clinical trials more than 16,000 subjects, of which approximately one-half have been outside of China. The Company has built, and is expanding, its internal manufacturing capabilities, through its state-of-the-art biologic and small molecule manufacturing facilities in China to support current and potential future demand of its medicines, and is building a commercial-stage biologics manufacturing and clinical R&D center in New Jersey. The Company also works with high quality contract manufacturing organizations ("CMOs") to manufacture its internally developed clinical and commercial products. Since its inception in 2010, the Company has become a fully integrated global organization of over 9,000 employees in 29 countries and regions, including the United States, China, Europe and Australia. Basis of presentation and consolidation The accompanying condensed consolidated balance sheet as of September 30, 2022, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2022 and 2021, the condensed consolidated statements of cash flows for the nine months ended September 30, 2022 and 2021, and the condensed consolidated statements of shareholders' equity for the three and nine months ended September 30, 2022 and 2021, and the related footnote disclosures are unaudited. The accompanying unaudited interim condensed financial statements were prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), including guidance with respect to interim financial information and in conformity with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for annual financial statements. These financial statements should be read in conjunction with the consolidated financial statements and related footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (the "Annual Report"). The unaudited interim condensed consolidated interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all normal recurring adjustments, necessary to present a fair statement of the results for the interim periods presented. Results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results expected for the full fiscal year or for any future annual or interim period. The unaudited interim condensed consolidated financial statements include the financial statements of the Company and its subsidiaries. All significant intercompany transactions and balances between the Company and its subsidiaries are eliminated upon consolidation. Use of estimates The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Areas where management uses subjective judgment include, but are not limited to, estimating the useful lives of long-lived assets, estimating variable consideration in product sales and collaboration revenue arrangements, identifying separate accounting units and determining the standalone selling price of each performance obligation in the Company’s revenue arrangements, assessing the impairment of long-lived assets, valuation and recognition of share-based compensation expenses, realizability of deferred tax assets, estimating uncertain tax positions, valuation of inventory, estimating the allowance for credit losses, determining defined benefit pension plan obligations, measurement of right-of-use assets and lease liabilities and the fair value of financial instruments. Management bases the estimates on historical experience, known trends and various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities and reported amounts of revenues and expenses. Actual results could differ from these estimates. Revision of prior period financial statements The Company evaluates the recoverability of its deferred tax assets on a jurisdiction-by-jurisdiction basis by assessing the adequacy of future expected taxable income from all sources, including reversal of temporary differences, forecasted operating earnings and available tax planning strategies in accordance with ASC 740. This assessment is subject to a high degree of subjectivity, as the sources of income rely heavily on estimates that are based on a number of factors, including historical experience and short-range and long-range business forecasts. A valuation allowance is provided when the Company determines that it is more-likely-than-not that some portion or all of a deferred tax asset will not be realized. Prior to the third quarter of 2022, the Company determined that the majority of its net deferred tax assets (primarily in the U.S.) were realizable on a more-likely-than-not basis, primarily due to cumulative pre-tax income at the taxpaying entity and the weighting of available positive and negative evidence. Accordingly, no valuation allowance was previously recorded related to those deferred tax assets. In October 2022, in connection with the preparation of its condensed consolidated financial statements for the three and nine months ended September 30, 2022, the Company reassessed its position on the realizability of its net deferred tax assets and determined that the negative evidence associated with cumulative losses at the consolidated financial statement level are not able to be overcome by other positive evidence, and therefore, a valuation allowance should be applied to its net deferred tax asset balance. The Company determined the previous conclusion to not apply a valuation allowance to certain net deferred tax assets was an error. In accordance with Staff Accounting Bulletin (SAB) No. 99, “Materiality,” and SAB No. 108, “Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements,” the Company evaluated the error and determined that the related impact was not material to any of its previously issued financial statements, but that correcting the cumulative impact of the error would be significant to its statements of operations for the three and nine months ended September 30, 2022. Accordingly, the Company has revised the first and second quarters of 2022 and the quarterly and annual periods of fiscal year 2021 condensed consolidated financial statements and related notes included herein to record a valuation allowance against the Company’s net deferred tax asset balance for all periods presented. A summary of revisions to previously reported financial statements is presented in Note 2, Revision of Prior Period Financial Statements. Note 9, Income Taxes and Note 13, Loss Per Share have been updated to reflect the revision. The Company will also correct previously reported financial information for this error in its future filings, as applicable. Recent accounting pronouncements New accounting standards which have not yet been adopted In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance . This update requires certain annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy. This update is effective for annual periods beginning after December 15, 2021, and early application is permitted. This guidance should be applied either prospectively to all transactions that are reflected in financial statements at the date of initial application and new transactions that are entered into after the date of initial application or retrospectively to those transactions. The Company does not expect the adoption of this guidance to have a material impact on the Company’s consolidated financial statements. Significant accounting policies For a more complete discussion of the Company’s significant accounting policies and other information, the unaudited interim condensed consolidated financial statements and notes thereto should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2021. There have been no material changes to the Company’s significant accounting policies as of and for the nine months ended September 30, 2022, as compared to the significant accounting policies described in the Annual Report. |
Revision of Prior Period Financ
Revision of Prior Period Financial Statements | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Changes and Error Corrections [Abstract] | |
Revision of Prior Period Financial Statements | Revision of Prior Period Financial Statements As discussed in Note 1, the Company revised certain prior period financial statements to correct 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 quarters of 2022 and the quarterly and annual periods of fiscal 2021 (See Note 1). Specifically, a valuation allowance should have been recorded on all net deferred tax assets and such a valuation allowance was not previously recorded. A summary of revisions to the Company’s previously reported financial statements for the comparative periods presented within this Quarterly Report on Form 10-Q is presented below. Condensed Consolidated Balance Sheet (unaudited) As of December 31, 2021 As Reported Adjustments As Revised $ $ $ Deferred tax assets 110,424 (110,424) — Total non-current assets 1,032,069 (110,424) 921,645 Total assets 8,645,949 (110,424) 8,535,525 Accumulated deficit (4,966,103) (110,424) (5,076,527) Total equity 6,242,987 (110,424) 6,132,563 Total liabilities and equity 8,645,949 (110,424) 8,535,525 Condensed Consolidated Statements of Operations (unaudited) Three Months Ended Nine Months Ended September 30, 2021 September 30, 2021 As Reported Adjustments As Revised As Reported Adjustments As Revised $ $ $ $ $ $ Income tax expense (benefit) (19,223) 24,259 5,036 (24,083) 39,437 15,354 Net loss (413,855) (24,259) (438,114) (827,701) (39,437) (867,138) Net loss per share (0.34) (0.02) (0.36) (0.69) (0.03) (0.72) Net loss per American Depositary Share ("ADS") (4.46) (0.26) (4.72) (8.99) (0.43) (9.42) Condensed Consolidated Statements of Comprehensive Loss (unaudited) Three Months Ended Nine Months Ended September 30, 2021 September 30, 2021 As Reported Adjustments As Revised As Reported Adjustments As Revised $ $ $ $ $ $ Net loss (413,855) (24,259) (438,114) (827,701) (39,437) (867,138) Comprehensive loss (413,370) (24,259) (437,629) (822,063) (39,437) (861,500) Condensed Consolidated Statement of Cash Flows (unaudited) Nine Months Ended September 30, 2021 As Reported Adjustments As Revised $ $ $ Operating activities: Net loss (827,701) (39,437) (867,138) Adjustments to reconcile net loss to net cash used in operating activities: Deferred income tax benefits (38,408) 40,882 2,474 Changes in operating assets and liabilities: Other assets (92,938) 449 (92,489) Accrued expenses and other payables 819 (863) (44) Other liabilities 3,438 (1,031) 2,407 Net cash used in operating activities (790,884) — (790,884) Condensed Consolidated Statement of Stockholders' Equity (unaudited) Accumulated Deficit Total Equity As Reported Adjustments As Revised As Reported Adjustments As Revised $ $ $ $ $ $ Balance at December 31, 2021 (4,966,103) (110,424) (5,076,527) 6,242,987 (110,424) 6,132,563 Net loss (434,274) (924) (435,198) (434,274) (924) (435,198) Balance at March 31, 2022 (5,400,377) (111,348) (5,511,725) 5,885,500 (111,348) 5,774,152 Net loss (571,449) 5,723 (565,726) (571,449) 5,723 (565,726) Balance at June 30, 2022 (5,971,826) (105,625) (6,077,451) 5,302,544 (105,625) 5,196,919 Balance at December 31, 2020 (3,552,749) (65,962) (3,618,711) 3,869,243 (65,962) 3,803,281 Net income 66,495 (10,915) 55,580 66,495 (10,915) 55,580 Balance at March 31, 2021 (3,486,254) (76,877) (3,563,131) 4,003,587 (76,877) 3,926,710 Net loss (480,341) (4,263) (484,604) (480,341) (4,263) (484,604) Balance at June 30, 2021 (3,966,595) (81,140) (4,047,735) 3,606,775 (81,140) 3,525,635 Net loss (413,855) (24,259) (438,114) (413,855) (24,259) (438,114) Balance at September 30, 2021 (4,380,450) (105,399) (4,485,849) 3,357,073 (105,399) 3,251,674 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company measures certain financial assets and liabilities at fair value. Fair value is determined based upon the exit price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants, as determined by either the principal market or the most advantageous market. Inputs used in the valuation techniques to derive fair values are classified based on a three-level hierarchy, as follows: Level 1 – Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. Level 2 – Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the asset or liability. The Company considers an active market to be one in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis, and considers an inactive market to be one in which there are infrequent or few transactions for the asset or liability, the prices are not current, or price quotations vary substantially either over time or among market makers. The following tables present the Company’s financial assets and liabilities measured and recorded at fair value on a recurring basis using the above input categories as of September 30, 2022 and December 31, 2021: Quoted Price in Active Market for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs As of September 30, 2022 (Level 1) (Level 2) (Level 3) $ $ $ Cash equivalents U.S. Treasury securities 123,519 — — Money market funds 373,370 — — Short-term investments (Note 5): U.S. Treasury securities 871,998 — — Other non-current assets (Note 5): Equity securities with readily determinable fair values 6,467 2,037 — Convertible debt instrument — — 5,000 Total 1,375,354 2,037 5,000 Quoted Price in Active Market for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs As of December 31, 2021 (Level 1) (Level 2) (Level 3) $ $ $ Cash equivalents U.S. Treasury securities 107,855 — — Money market funds 315,564 — — Short-term investments (Note 5): U.S. Treasury securities 2,241,962 — — Other non-current assets (Note 5): Equity securities with readily determinable fair values 23,809 10,306 — Total 2,689,190 10,306 — The Company's cash equivalents are highly liquid investments with original maturities of 3 months or less. Short-term investments represent the Company's investments in available-for-sale debt securities. The Company determines the fair value of cash equivalents and available-for-sale debt securities using a market approach based on quoted prices in active markets. The Company's equity securities carried at fair value consist of holdings in common stock and warrants to purchase additional shares of common stock of Leap Therapeutics, Inc. ("Leap"), which were acquired in connection with a collaboration and license agreement entered into in January 2020 and in Leap's underwritten public offering in September 2021. The common stock investment in Leap, a publicly-traded biotechnology company, is measured and carried at fair value and classified as Level 1. The warrants to purchase additional shares of common stock in Leap are classified as a Level 2 investment and are measured using the Black-Scholes option-pricing valuation model, which utilizes a constant maturity risk-free rate and reflects the term of the warrants, dividend yield and stock price volatility, that is based on the historical volatility of similar companies. Refer to Note 5, Restricted Cash and Investments for details of the determination of the carrying amount of private equity investments without readily determinable fair values and equity method investments. The Company holds a convertible note of a private biotech company. The Company has elected the fair value option method of accounting for the convertible note. Accordingly, the convertible note is remeasured at fair value on a recurring basis using Level 3 inputs, with any changes in the fair value option recorded in other income (loss). As of September 30, 2022 and December 31, 2021, the fair values of cash and cash equivalents, restricted cash, accounts receivable, accounts payable, and short-term debt approximated their carrying values due to their short-term nature. Long-term |
Collaborative and Licensing Arr
Collaborative and Licensing Arrangements | 9 Months Ended |
Sep. 30, 2022 | |
Research and Development [Abstract] | |
Collaborative and Licensing Arrangements | Collaborative and Licensing Arrangements The Company has entered into collaborative arrangements for the research and development, manufacture and/or commercialization of medicines and drug candidates. To date, these collaborative arrangements have included out-licenses of and options to out-license internally developed products and drug candidates to other parties, in-licenses of products and drug candidates from other parties, and profit- and cost-sharing arrangements. These arrangements may include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost-sharing and reimbursement arrangements, royalty payments, and profit sharing. Out-Licensing Arrangements For the three and nine months ended September 30, 2022 and 2021, the Company’s collaboration revenue consisted entirely of upfront license fees, research and development services revenue and right to access intellectual property revenue from its collaboration agreements with Novartis for tislelizumab and ociperlimab. The following table summarizes total collaboration revenue recognized for the three and nine months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Revenue from Collaborators $ $ $ $ License revenue — — — 484,646 Research and development service revenue 9,834 13,979 34,074 40,456 Right to access intellectual property revenue 26,249 — 78,746 — Other 2,039 — 7,416 — Total 38,122 13,979 120,236 525,102 Novartis Tislelizumab Collaboration and License In January 2021, the Company entered into a collaboration and license agreement with Novartis, granting Novartis rights to develop, manufacture and commercialize tislelizumab in North America, Europe, and Japan ("Novartis Territory"). The Company and Novartis have agreed to jointly develop tislelizumab in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals. In addition, both companies may conduct clinical trials globally to explore combinations of tislelizumab with other cancer treatments, and the Company has an option to co-detail the product in North America, funded in part by Novartis. Under the agreement the Company received an upfront cash payment of $650,000 from Novartis. The Company is eligible to receive up to $1,300,000 upon the achievement of regulatory milestones, $250,000 upon the achievement of sales milestones, and royalties on future sales of tislelizumab in the licensed territory. Under the terms of the agreement, the Company is responsible for funding ongoing clinical trials of tislelizumab, Novartis has agreed to fund new registrational, bridging, or post-marketing studies in its territory, and each party will be responsible for funding clinical trials evaluating tislelizumab in combination with its own or third party products. Each party retains the worldwide right to commercialize its propriety products in combination with tislelizumab. The Company evaluated the Novartis agreement under ASC 606 as all the material units of account within the agreement represented transactions with a customer. The Company identified the following material components under the agreement: (1) exclusive license for Novartis to develop, manufacture, and commercialize tislelizumab in the Novartis Territory, transfer of know-how and use of the tislelizumab trademark; (2) conducting and completing ongoing trials of tislelizumab (“tislelizumab R&D services”); and (3) supplying Novartis with required quantities of the tislelizumab drug product, or drug substance, upon receipt of an order from Novartis. The Company determined that the license, transfer of know-how and use of trademarks are not distinct from each other and represent a single performance obligation. The tislelizumab R&D services represent a material promise and were determined to be a separate performance obligation at the outset of the agreement as the promise is distinct and has standalone value to Novartis. The Company evaluated the supply component of the contract and noted the supply will not be provided at a significant incremental discount to Novartis. The Company concluded that, for the purpose of ASC 606, the provision related to providing clinical and commercial supply of tislelizumab in the Novartis Territory was an option but not a performance obligation of the Company at the outset of the Novartis collaboration agreement. A performance obligation for the clinical and commercial supply will be established as quantities of drug product or drug substance are ordered by Novartis. The Company determined that the transaction price as of the outset of the arrangement was the upfront payment of $650,000. The potential milestone payments that the Company is eligible to receive were excluded from the transaction price, as all milestone amounts were fully constrained due to uncertainty of achievement. The transaction price was allocated to the two identified performance obligations based on a relative fair value basis. The standalone selling price of the license, transfer of know-how and use of trademarks performance obligation was determined using the adjusted market assessment approach. Based on the valuation performed by the Company, the standalone selling price of the license, transfer of know-how and use of trademarks was valued at $1,231,000. The standalone selling price of the tislelizumab R&D services was valued at $420,000 using a cost plus margin valuation approach. Based on the relative standalone selling prices of the two performance obligations, $484,646 of the total transaction price was allocated to the license and $165,354 was allocated to the tislelizumab R&D services. The Company satisfied the license performance obligation at a point in time when the license was delivered and the transfer of know-how completed which occurred during the nine months ended September 30, 2021. As such, the Company recognized the entire amount of the transaction price allocated to the license as collaboration revenue during the nine months ended September 30, 2021. The portion of the transaction price allocated to the tislelizumab R&D services was deferred and is being recognized as collaboration revenue as the tislelizumab R&D services are performed using a percentage-of-completion method. Estimated costs to complete are reassessed on a periodic basis and any updates to the revenue earned are recognized on a prospective basis. The Company recognized R&D service revenue of $8,043 and $28,699 during the three and nine months ended September 30, 2022, respectively, and $13,979 and $40,456 during the three and nine months ended September 30, 2021, respectively. The Company also recognized other collaboration revenue of $2,039 and $7,416 related to the sale of tislelizumab clinical supply to Novartis in conjunction with the collaboration during the three and nine months ended September 30, 2022, respectively. Ociperlimab Option, Collaboration and License Agreement and China Broad Market Development Agreement In December 2021, the Company expanded its collaboration with Novartis by entering into an option, collaboration and license agreement with Novartis to develop, manufacture and commercialize the Company's investigational TIGIT inhibitor ociperlimab in the Novartis Territory. In addition, the Company and Novartis entered into an agreement granting the Company rights to market, promote and detail five approved Novartis oncology products, TAFINLAR ® (dabrafenib), MEKINIST ® (trametinib), VOTRIENT ® (pazopanib), AFINITOR ® (everolimus), and ZYKADIA ® (ceritinib), across designated regions of China referred to as “broad markets.” In the first quarter of 2022, the Company initiated marketing and promotion of these five products. Under the terms of the option, collaboration and license agreement, the Company received an upfront cash payment of $300,000 in January 2022 from Novartis and will receive an additional payment of $600,000 or $700,000 in the event Novartis exercises its exclusive time-based option prior to mid-2023 or between then and late-2023, respectively. Following option exercise, the Company is eligible to receive up to $745,000 upon the achievement of regulatory approval milestones, $1,150,000 upon the achievement of sales milestones, and royalties on future sales of ociperlimab in the Novartis Territory. Subject to the terms of the option, collaboration and license agreement, during the option period, Novartis has agreed to initiate and fund additional global clinical trials with ociperlimab and the Company has agreed to expand enrollment in two ongoing trials. Following the option exercise, Novartis has agreed to share development costs of global trials. Following approval, the Company has agreed to provide 50 percent of the co-detailing and co-field medical efforts in the United States, and has an option to co-detail up to 25 percent in Canada and Mexico, funded in part by Novartis. Each party retains the worldwide right to commercialize its propriety products in combination with ociperlimab, as is the case with tislelizumab under the tislelizumab collaboration and license agreement. The existing tislelizumab collaboration and license agreement was not modified as a result of the ociperlimab option, collaboration and license agreement. The Company evaluated the Novartis agreements under ASC 606 as the units of account within the agreement represented transactions with a customer. The Company identified the following material promises under the agreement: (1) exclusive option for Novartis to license the rights to develop, manufacture, and commercialize ociperlimab in the Novartis Territory; (2) Novartis' right to access ociperlimab in its own clinical trials during the option period; (3) initial transfer of BeiGene know-how; and (4) conducting and completing ongoing trials of ociperlimab during the option period ("ociperlimab R&D Services", together with "tislelizumab R&D services", "R&D services"). The market development activities are considered immaterial in the context of the contracts. The Company concluded that, at the inception of the agreement, the option for the exclusive product license constitutes a material right as it represents a significant and incremental discount to the fair value of the exclusive product license that Novartis would not have received without entering into the agreement and is therefore considered a distinct performance obligation. The Company determined that Novartis' right to access ociperlimab in its own trials over the option period and the initial transfer of know-how were not distinct from each other, as the right to access ociperlimab has limited value without the corresponding know-how transfer, and therefore should be combined into one distinct performance obligation. The ociperlimab R&D Services represent a material promise and were determined to be a separate performance obligation at the outset of the agreement as the promise is distinct and has standalone value to Novartis. The Company determined the transaction price at the outset of the arrangement as the upfront payment of $300,000. The option exercise fee is contingent upon Novartis exercising its right and is considered fully constrained until the option is exercised. Additionally, the milestone and royalty payments are not applicable until after the option is exercised, at which point the likelihood of meeting milestones, regulatory approval and meeting certain sales thresholds will be assessed. The transaction price was allocated to the three identified performance obligations based on a relative fair value basis. The standalone selling price of the material right for the option to the exclusive product license was calculated as the incremental discount between (i) the value of the license determined using a discounted cash flow method adjusted for probability of the option being exercised and (ii) the expected option exercise fee using the most-likely-amount method at option exercise. The standalone selling price of the combined performance obligation for Novartis' right to access ociperlimab for its own clinical trials during the option period and the initial transfer of BeiGene know-how was determined using a discounted cash flow method. The standalone selling price of the ociperlimab R&D Services was determined using an expected cost plus margin approach. Based on the relative standalone selling prices of the three performance obligations, $71,980 of the total transaction price was allocated to the material right, $213,450 was allocated to Novartis' right to use ociperlimab in its own clinical trials during the option period and the transfer of BeiGene know-how, and $14,570 was allocated to the ociperlimab R&D Services. The Company will satisfy the material right performance obligation at a point in time at the earlier of when Novartis exercises the option and the license is delivered or the expiration of the option period. As such, the entire amount of the transaction price allocated to the material right was deferred. The portion of the transaction price allocated to Novartis' right to access ociperlimab in its own clinical trials during the option period and the initial transfer of BeiGene know-how was deferred and is being recognized over the expected option period. The portion of the transaction price allocated to the ociperlimab R&D Services was deferred and is being recognized as collaboration revenue as the ociperlimab R&D Services are performed over the expected option period. The Company recognized collaboration revenue of $26,249 and $78,746 related to Novartis right to access ociperlimab in clinical trials and the transfer of know how performance obligation during the three and nine months ended September 30, 2022, respectively, and R&D service revenue of $1,791 and $5,375 during the three and nine months ended September 30, 2022, respectively. In-Licensing Arrangements Amgen In October 2019, the Company entered into a global strategic oncology collaboration with Amgen ("Amgen Collaboration Agreement") for the commercialization and development in China, excluding Hong Kong, Taiwan and Macau, of Amgen’s XGEVA ® , KYPROLIS ® , and BLINCYTO ® , and the joint global development of a portfolio of oncology assets in Amgen’s pipeline, with BeiGene responsible for development and commercialization in China. The agreement became effective on January 2, 2020, following approval by the Company's shareholders and satisfaction of other closing conditions. Under the agreement, the Company is responsible for the commercialization of XGEVA ® , KYPROLIS ® and BLINCYTO ® in China for five ® was approved in China in 2019 for patients with giant cell tumor of the bone and in November 2020 for the prevention of skeletal-related events in cancer patients with bone metastases. In July 2020, the Company began commercializing XGEVA ® in China. In December 2020, BLINCYTO ® was approved in China for injection for the treatment of adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL). In July 2021, KYPROLIS ® was conditionally approved in China for injection in combination with dexamethasone for the treatment of adult patients with R/R multiple myeloma. In April 2022, BLINCYTO ® was conditionally approved for injection for the treatment of pediatric patients with R/R CD19-positive B-cell precursor ALL. Amgen and the Company are also jointly developing a portfolio of Amgen oncology pipeline assets under the collaboration. The Company is responsible for conducting clinical development activities in China and co-funding global development costs by contributing cash and development services up to a total cap of $1,250,000. Amgen is responsible for all development, regulatory and commercial activities outside of China. For each pipeline asset that is approved in China, the Company will receive commercial rights for seven years from approval. The Company has the right to retain approximately one out of every three approved pipeline assets, other than LUMAKRAS ™ (sotorasib), Amgen's KRAS G12C inhibitor, for commercialization in China. The Company and Amgen will share equally in the China commercial profits and losses during the commercialization period. The Company is entitled to receive royalties from sales in China for pipeline assets returned to Amgen for five years after the seven-year commercialization period. The Company is also entitled to receive royalties from global sales of each product outside of China (with the exception of LUMAKRAS™). The Amgen Collaboration Agreement is within the scope of ASC 808, as both parties are active participants and are exposed to the risks and rewards dependent on the commercial success of the activities performed under the agreement. The Company is the principal for product sales to customers in China during the commercialization period and recognizes 100% of net product revenue on these sales. Amounts due to Amgen for its portion of net product sales will be recorded as cost of sales. Cost reimbursements due to or from Amgen under the profit share will be recognized as incurred and recorded to cost of sales; selling, general and administrative expense; or research and development expense, based on the underlying nature of the related activity subject to reimbursement. Costs incurred for the Company's portion of the global co-development funding are recorded to research and development expense as incurred. On April 20, 2022, the parties entered into the First Amendment to Amgen Collaboration Agreement, which amends certain terms and conditions relating to the financial responsibilities of the parties in connections with the development and commercialization of certain Amgen proprietary products for the treatment of oncology-related diseases and conditions. In connection with the Amgen Collaboration Agreement, a Share Purchase Agreement ("SPA") was entered into by the parties in October 2019. On January 2, 2020, the closing date of the transaction, Amgen purchased 15,895,001 of the Company's ADSs for $174.85 per ADS, representing a 20.5% ownership stake in the Company. Per the SPA, the cash proceeds shall be used as necessary to fund the Company's development obligations under the Amgen Collaboration Agreement. Pursuant to the SPA, Amgen also received the right to designate one member of the Company's board of directors, and Anthony Hooper joined the Company's board of directors as the Amgen designee in January 2020. In determining the fair value of the common stock at closing, the Company considered the closing price of the common stock on the closing date of the transaction and included a lack of marketability discount because the shares are subject to certain restrictions. The fair value of the shares on the closing date was determined to be $132.74 per ADS, or $2,109,902 in the aggregate. The Company determined that the premium paid by Amgen on the share purchase represents a cost share liability due to the Company's co-development obligations. The fair value of the cost share liability on the closing date was determined to be $601,857 based on the Company's discounted estimated future cash flows related to the pipeline assets. The total cash proceeds of $2,779,241 were allocated based on the relative fair value method, with $2,162,407 recorded to equity and $616,834 recorded as a research and development cost share liability. The cost share liability is being amortized proportionately as the Company contributes cash and development services to its total co-development funding cap. Amounts recorded related to the Company's portion of the co-development funding on the pipeline assets for the three and nine months ended September 30, 2022 and 2021 were as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ Research and development expense 25,462 29,710 72,251 85,040 Amortization of research and development cost share liability 24,806 28,943 70,389 82,846 Total amount due to Amgen for BeiGene's portion of the development funding 50,268 58,653 142,640 167,886 As of September 30, 2022 Remaining portion of development funding cap 648,419 As of September 30, 2022 and December 31, 2021, the research and development cost share liability recorded in the Company's balance sheet was as follows: As of September 30, December 31, 2022 2021 $ $ Research and development cost share liability, current portion 115,721 120,801 Research and development cost share liability, non-current portion 204,252 269,561 Total research and development cost share liability 319,973 390,362 The total reimbursement due under the commercial profit-sharing agreement for product sales is classified in the income statement for the three and nine months ended September 30, 2022 and 2021 as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ Cost of sales - product 319 380 3,797 1,058 Research and development (1,125) (373) (227) (310) Selling, general and administrative (13,854) (12,552) (40,496) (28,469) Total (14,660) (12,545) (36,926) (27,721) The Company purchases commercial inventory from Amgen to distribute in China. Inventory purchases amounted to $29,269 and $59,330 during the three and nine months ended September 30, 2022, respectively, and $32,129 and $50,983 during the three and nine months ended September 30, 2021, respectively. Net amounts payable to Amgen as of September 30, 2022 and December 31, 2021 were $95,087 and $106,790, respectively. |
Restricted Cash and Investments
Restricted Cash and Investments | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Restricted Cash and Investments | Restricted Cash and Investments Restricted Cash The Company’s restricted cash balance of $3,380 and $7,209 as of September 30, 2022 and December 31, 2021, respectively, primarily consists of RMB-denominated cash deposits held in designated bank accounts for collateral for letters of credit. The Company classifies restricted cash as current or non-current based on the term of the restriction. In addition to the restricted cash balances above, the Company is required by the PRC securities law to use the proceeds from the STAR offering in strict compliance with the planned uses as disclosed in the PRC prospectus as well as those disclosed in the Company's proceeds management policy approved by the board of directors. Short-Term Investments Short-term investments as of September 30, 2022 consisted of the following available-for-sale debt securities: Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) $ $ $ $ U.S. Treasury securities 883,126 — 11,128 871,998 Total 883,126 — 11,128 871,998 Short-term investments as of December 31, 2021 consisted of the following available-for-sale debt securities: Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) $ $ $ $ U.S. Treasury securities 2,245,662 — 3,700 2,241,962 Total 2,245,662 — 3,700 2,241,962 As of September 30, 2022, the Company's available-for-sale debt securities consisted entirely of short-term U.S. treasury securities, which were determined to have zero risk of expected credit loss. Accordingly, no allowance for credit loss was recorded as of September 30, 2022. Equity Securities with Readily Determinable Fair Values Leap Therapeutics, Inc. (Leap) In January 2020, the Company purchased $5,000 of Series B mandatorily convertible, non-voting preferred stock of Leap in connection with a strategic collaboration and license agreement the Company entered into with Leap. The Series B shares were subsequently converted into shares of Leap common stock and warrants to purchase additional shares of common stock upon approval of Leap's shareholders in March 2020. In September 2021, the Company purchased $7,250 of common stock in Leap's underwritten public offering. As of September 30, 2022, the Company's ownership interest in the outstanding common stock of Leap was 7.4% based on information from Leap. Inclusive of the shares of common stock issuable upon the exercise of the currently exercisable warrants, the Company's interest is approximately 11.7% based on information from Leap. The Company measures the investment in the common stock and warrants at fair value, with changes in fair value recorded to other income (expense), net. The Company recorded unrealized losses of $2,950 and $25,611 for the three and nine months ended September 30, 2022, respectively, and unrealized gains of $23,764 and $18,388 for the three and nine months ended September 30, 2021, respectively, in the consolidated statements of operations. As of September 30, 2022 and December 31, 2021, the fair value of the common stock and warrants was as follows: As of September 30, December 31, 2022 2021 $ $ Fair value of Leap common stock 6,467 23,809 Fair value of Leap warrants 2,037 10,306 Private Equity Securities without Readily Determinable Fair Values The Company invests in equity securities of certain companies whose securities are not publicly traded and fair value is not readily determinable and where the Company has concluded it does not have significant influence based on its ownership percentage and other factors. These investments are recorded at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer. The Company held investments of $56,789 and $43,722 in equity securities without readily determinable fair values as of September 30, 2022 and December 31, 2021, respectively. The Company recorded gains of $4,699 and $5,065 related to observable price changes in orderly transactions for similar investments of the same issuer for the three and nine months ended September 30, 2022, respectively, to other income (expense), net in the consolidated statements of operations. Equity-Method Investments |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories The Company’s inventory balance consisted of the following: As of September 30, December 31, 2022 2021 $ $ Raw materials 88,953 78,140 Work in process 22,737 9,397 Finished goods 179,221 155,089 Total inventories 290,911 242,626 |
Property, plant and equipment
Property, plant and equipment | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property, plant and equipment | Property, plant and equipment Property, plant and equipment are recorded at cost and consisted of the following: As of September 30, December 31, 2022 2021 $ $ Land 65,485 65,485 Laboratory equipment 137,990 118,203 Leasehold improvements 50,005 50,288 Building 170,243 144,083 Manufacturing equipment 147,433 119,585 Software, electronics and office equipment 38,257 27,404 Property, plant and equipment, at cost 609,413 525,048 Less: accumulated depreciation (149,692) (124,286) Construction in progress 222,193 186,843 Property, plant and equipment, net 681,914 587,605 In November 2021, the Company purchased a 42-acre site located in Hopewell, NJ for $75,197. The total purchase price was allocated between the land and an existing building on the property based on their relative fair values. The Company is constructing a biologics manufacturing facility and research and development center on the land. Depreciation expense was $15,214 and $45,255 for the three and nine months ended September 30, 2022, respectively, and $11,773 and $32,440 for the three and nine months ended September 30, 2021, respectively. |
Intangible Assets
Intangible Assets | 9 Months Ended |
Sep. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible Assets Intangible assets as of September 30, 2022 and December 31, 2021 are summarized as follows: As of September 30, 2022 December 31, 2021 Gross Gross carrying Accumulated Intangible carrying Accumulated Intangible amount amortization assets, net amount amortization assets, net $ $ $ $ $ $ Finite-lived intangible assets: Product distribution rights 7,500 (3,813) 3,687 7,500 (3,250) 4,250 Developed product 40,432 (3,270) 37,162 43,394 (965) 42,429 Trading license 816 (816) — 816 (816) — Total finite-lived intangible assets 48,748 (7,899) 40,849 51,710 (5,031) 46,679 Product distribution rights consist of distribution rights on the approved cancer therapies licensed from Bristol Myers Squibb Company ("BMS") as part of the BMS collaboration. The Company is amortizing the product distribution rights, as a single identified asset, over a period of 10 years from the date of acquisition. Developed products represent the post-approval milestone payments under license and commercialization agreements. The Company is amortizing the developed products over the remainder of the respective product patent or the term of the commercialization agreements. Trading license represents the Guangzhou drug distribution license acquired in September 2018. The Company amortized the drug distribution trading license over the remainder of the initial license term through February 2020. The trading license has been renewed through February 2024. Amortization expense for developed product is included in cost of sales - product in the accompanying consolidated statements of operations. Amortization expense for product distribution rights and the trading licenses is included in operating expenses in the accompanying consolidated statements of operations. The weighted-average life for each finite-lived intangible assets is approximately 12 years. Amortization expense was as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ Amortization expense - Cost of sales - product 800 216 2,444 333 Amortization expense - Operating expense 187 188 563 563 987 404 3,007 896 Estimated amortization expense for each of the five succeeding years and thereafter, as of September 30, 2022 is as follows: Year Ending December 31, Cost of Sales - Product Operating Expenses Total $ $ $ 2022 (remainder of year) 779 188 967 2023 3,117 750 3,867 2024 3,117 750 3,867 2025 3,117 750 3,867 2026 3,117 750 3,867 2027 and thereafter 23,915 499 24,414 Total 37,162 3,687 40,849 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Income tax expense was $6,318 and $28,408 for the three and nine months ended September 30, 2022, respectively. Income tax expense was $5,036 and $15,354 for the three and nine months ended September 30, 2021, respectively. The income tax expense for the three and nine months ended September 30, 2022 was primarily attributable to current China tax expense for certain subsidiaries determined after certain non-deductible expenses and current U.S. tax expense determined after other special tax deductions and research and development tax credits. The income tax expense for the three and nine months ended September 30, 2021 was primarily attributable to current China tax expense for certain subsidiaries determined after certain non-deductible expenses. On a quarterly basis, the Company evaluates the realizability of deferred tax assets by jurisdiction and assesses the need for a valuation allowance. In assessing the realizability of deferred tax assets, the Company considers historical profitability, evaluation of scheduled reversals of deferred tax liabilities, projected future taxable income and tax-planning strategies. Valuation allowances have been provided on deferred tax assets where, based on all available evidence, it was considered more likely than not that some portion or all of the recorded deferred tax assets will not be realized in future periods. After consideration of all positive and negative evidence, as of September 30, 2022 and September 30, 2021, the Company will maintain a full valuation allowance against its net deferred tax assets. As of September 30, 2022, the Company had gross unrecognized tax benefits of $12,725. The Company does not anticipate that the amount of existing unrecognized tax benefits will significantly change within the next 12 months. The Company’s reserve for uncertain tax positions increased by $960 and $2,800, respectively, in the three and nine months ended September 30, 2022 primarily due to U.S. federal and state tax credits and incentives. The Company has elected to record interest and penalties related to income taxes as a component of income tax expense. As of September 30, 2022 and December 31, 2021, the Company's accrued interest and penalties, where applicable, related to uncertain tax positions were not material. The Company conducts business in a number of tax jurisdictions and, as such, is required to file income tax returns in multiple jurisdictions globally. As of September 30, 2022, Australia tax matters are open to examination for the years 2013 through 2022, China tax matters are open to examination for the years 2012 through 2022, Switzerland tax matters are open to examination for the years 2018 through 2022, and U.S. federal tax matters are open to examination for years 2015 through 2022. Various U.S. states and other non-US tax jurisdictions in which the Company files tax returns remain open to examination for 2012 through 2022. |
Supplemental Balance Sheet Info
Supplemental Balance Sheet Information | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Supplemental Balance Sheet Information | Supplemental Balance Sheet Information The roll-forward of the allowance for credit losses related to trade accounts receivable for the nine months ended September 30, 2022 and 2021 consists of the following activity: Nine Months Ended September 30, 2022 2021 $ $ Balance at beginning of the period 415 112 Current period provision for expected credit losses (161) (7) Amounts written-off — — Exchange rate changes (2) 3 Balance at end of the period 252 108 Prepaid expenses and other current assets consist of the following: As of September 30, December 31, 2022 2021 $ $ Prepaid research and development costs 74,575 87,239 Prepaid manufacturing cost 60,971 78,538 Prepaid taxes 11,494 58,579 Other receivables 11,272 12,010 Interest receivable 2,203 5,052 Prepaid insurance 6,465 1,695 Short-term deposit 10,917 2,982 Other current assets 21,869 24,078 Total 199,766 270,173 Other non-current assets consist of the following: As of September 30, December 31, 2022 2021 $ $ Goodwill 109 109 Prepayment of property and equipment 17,951 14,140 Prepayment of facility capacity expansion activities (1) 19,676 24,237 Prepaid VAT 217 17,162 Rental deposits and other 6,520 6,609 Long-term investments 96,080 100,792 Total 140,553 163,049 (1) Represents payments for facility expansions under commercial supply agreements. The payments are providing future benefit to the Company through credits on commercial supply purchases. Accrued expenses and other payables consist of the following: As of September 30, December 31, 2022 2021 $ $ Compensation related 142,837 139,966 External research and development activities related 114,008 213,922 Commercial activities 34,646 71,560 Employee tax withholdings 25,879 45,661 Sales rebates and returns related 49,890 59,639 Professional fees and other 42,995 27,307 Total 410,255 558,055 Other long-term liabilities consist of the following: As of September 30, December 31, 2022 2021 $ $ Deferred government grant income 37,700 46,352 Pension liability 7,330 7,814 Other 139 68 Total 45,169 54,234 |
Debt
Debt | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Debt The following table summarizes the Company's short-term and long-term debt obligations as of September 30, 2022 and December 31, 2021: Lender Agreement Date Line of Credit Term Maturity Date Interest Rate As of September 30, 2022 December 31, 2021 $ RMB $ RMB China Construction Bank April 4, 2018 RMB580,000 9-year April 4, 2027 (1) 4,077 29,000 1,255 8,000 China Merchants Bank January 22, 2020 (2) 9-year January 20, 2029 (2) 1,406 10,000 1,569 10,000 China Merchants Bank November 9, 2020 RMB378,000 9-year November 8, 2029 (3) 3,866 27,500 — — China Minsheng Bank (the "Senior Loan") September 24, 2020 $200,000 (4) 4.5 % 200,000 1,422,677 200,000 1,274,535 Zhuhai Hillhouse (the "Related Party Loan") September 24, 2020 RMB500,000 (5) 4.5 % 14,058 100,000 15,693 100,000 Shanghai Pudong Development Bank February 25, 2022 $50,000 1-year February 25, 2023 2.2 % 50,000 355,669 — — Other short-term debt (6) 167,868 1,194,115 209,048 1,332,197 Total short-term debt 441,275 3,138,961 427,565 2,724,732 China Construction Bank April 4, 2018 RMB580,000 9-year April 4, 2027 (1) 76,616 545,000 89,444 570,000 China Merchants Bank January 22, 2020 (2) 9-year January 20, 2029 (2) 49,273 350,500 53,353 340,000 China Merchants Bank November 9, 2020 RMB378,000 9-year November 8, 2029 (3) 46,743 332,500 59,316 378,000 China CITIC Bank July 29, 2022 RMB480,000 10-year July 28, 2032 (7) 35,426 252,000 — — Total long-term bank loans 208,058 1,480,000 202,113 1,288,000 1. The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC. The loan interest rate was 4.9% as of September 30, 2022. The loan is secured by BeiGene Guangzhou Factory's land use right and certain Guangzhou Factory fixed assets in the first phase of the Guangzhou manufacturing facility's build out. The Company repaid $598(RMB4,000) during the nine months ended September 30, 2022. 2. On January 22, 2020, BeiGene Guangzhou Biologics Manufacturing Co., Ltd.("BeiGene Guangzhou Factory") entered into a nine-year bank loan with China Merchants Bank to borrow up to RMB1,100,000 at a floating interest rate benchmarked against prevailing interest rates of certain PRC financial institutions. The loan is secured by Guangzhou Factory's second land use right and fixed assets placed into service upon completion of the second phase of the Guangzhou manufacturing facility's build out. In connection with the Company's short-term loan agreements with China Merchants Bank entered into during the year ended December 31, 2020, the borrowing capacity was reduced from RMB1,100,000 to RMB350,000. The loan interest rate was 4.4% as of September 30, 2022. The Company repaid $1,142 (RMB7,500) during the nine months ended September 30, 2022. BeiGene Guangzhou Biologics Manufacturing Co., Ltd. is a company incorporated under the laws of the PRC on March 3, 2017 and a wholly owned subsidiary of BeiGene Biologics. 3. The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC. The loan interest rate was 4.3% as of September 30, 2022. The loan is secured by fixed assets placed into service upon completion of the third phase of the Guangzhou manufacturing facility's build out. 4. In September 2020, the Company entered into a loan agreement with China Minsheng Bank for a total loan facility of up to $200,000 ("Senior Loan"), of which $120,000 was designated to fund the purchase of noncontrolling equity interest in BeiGene Biologics Co., Ltd. ("BeiGene Biologics") from Guangzhou GET Technology Development Co., Ltd. (now Guangzhou High-tech Zone Technology Holding Group Co., Ltd.) ("GET") and repayment of the loan provided by GET ("Shareholder Loan") and $80,000 was designated for general working capital purposes. The Senior Loan had an original maturity date of October 8, 2021, which was the first anniversary of the first date of utilization of the loan. The Company may extend the original maturity date for up to two additional 12 month periods. On October 8, 2021, the Company extended the maturity date for twelve months to October 8, 2022 and repurposed the Senior Loan for general working capital purposes. BeiGene Biologics Co., Ltd. is a company incorporated under the laws of the PRC on January 25, 2017 and an indirectly wholly owned subsidiary of the Company. 5. In September 2020, the Company entered into a loan agreement with Zhuhai Hillhouse Zhaohui Equity Investment Partnership (Zhuhai Hillhouse) for a total loan facility of $73,640 (RMB500,000) ("Related Party Loan"), of which $14,728 (RMB100,000) can be used for general corporate purposes and $58,912 (RMB400,000) can only be applied towards the repayment of the Senior Loan facility, including principal, interest and fees. The loan maturity was the earlier of: (i) November 9, 2021, which is one month after the Senior Loan maturity date, if not extended, or (ii) 10 business days after the Senior Loan is fully repaid. On October 8, 2021, the Company extended the maturity date of the Related Party Loan to the earlier of: (i) November 9, 2022, which is one month after the Senior Loan maturity date, if not extended, or (ii) 10 business days after the Senior Loan is fully repaid. Zhuhai Hillhouse is a related party of the Company, as it is an affiliate of Hillhouse Capital. Hillhouse Capital is a shareholder of the Company, and a Hillhouse Capital employee is a member of the Company's board of directors. 6. During the nine months ended September 30, 2022 and the years ended December 31, 2021 and 2020, the Company entered into additional short-term working capital loans with China Industrial Bank and China Merchants Bank to borrow up to RMB2,435,000 in aggregate, with maturity dates ranging from January 19, 2021 to September 18, 2023. The Company drew down $113,774 (RMB792,000) and repaid $143,688 (RMB930,082) of the short-term loans in the nine months ended September 30, 2022. The weighted average interest rate for the short-term working capital loans was approximately 3.1% as of September 30, 2022. 7. In July 2022, the Company entered into a 10-year bank loan agreement with China CITIC Bank to borrow up to RMB480,000 at a floating interest rate benchmarked against prevailing interest rates of certain PRC financial institutions. The loan interest rate was 4.2% as of September 30, 2022. The loan is secured by BeiGene Suzhou Co., Ltd.'s land use right. The Company drew down $37,372(RMB252,000) during the nine months ended September 30, 2022. Interest Expense Interest expense recognized for the three and nine months ended September 30, 2022 was $5,596 and $16,580, respectively, among which, $527 and $2,462 was capitalized, respectively. Interest expense recognized for the three and nine months ended September 30, 2021 was $7,609 and $22,186, respectively, among which, $275 and $526 was capitalized, respectively. |
Product Revenue
Product Revenue | 9 Months Ended |
Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Product Revenue | Product Revenue The Company’s product revenue is primarily derived from the sale of its internally developed products BRUKINSA ® in the United States and China, and tislelizumab and pamiparib in China; REVLIMID ® and VIDAZA ® in China under a license from BMS; XGEVA ® , BLINCYTO ® and KYPROLIS ® in China under a license from Amgen; and POBEVCY ® in China under a license from Bio-Thera. The table below presents the Company’s net product sales for the three and nine months ended September 30, 2022 and 2021. Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ Product revenue – gross 398,379 206,029 1,036,652 497,823 Less: Rebates and sales returns (48,873) (13,568) (121,062) (60,621) Product revenue – net 349,506 192,461 915,590 437,202 The following table disaggregates net product sales by product for the three and nine months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ BRUKINSA ® 155,495 65,832 388,567 130,345 Tislelizumab 128,206 76,980 320,728 200,738 REVLIMID ® 19,046 20,209 60,622 46,984 XGEVA ® 18,148 15,699 47,156 33,491 POBEVCY ® 9,873 — 29,671 — KYPROLIS ® 2,820 — 11,225 — BLINCYTO ® 6,214 5,040 27,610 5,040 VIDAZA ® 3,314 5,810 12,260 12,771 Pamiparib 1,266 1,516 5,843 3,737 Other 5,124 1,375 11,908 4,096 Total product revenue – net 349,506 192,461 915,590 437,202 The following table presents the roll-forward of accrued sales rebates and returns for the nine months ended September 30, 2022 and 2021: Nine Months Ended September 30, 2022 2021 $ $ Balance at beginning of the period 59,639 11,874 Accrual 121,062 60,621 Payments (130,811) (52,305) Balance at end of the period 49,890 20,190 |
Loss Per Share
Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Loss Per Share | Loss Per Share The following table reconciles the numerator and denominator in the computations of basic and diluted loss per share: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ Numerator: Net loss (557,556) (438,114) (1,558,480) (867,138) Denominator: Weighted average shares outstanding—basic and diluted 1,345,303,747 1,205,971,284 1,337,976,853 1,196,391,201 For the three and nine months ended September 30, 2022 and 2021, the computation of basic loss per share using the two-class method was not applicable as the Company was in a net loss position, and the effects of all share options, restricted shares, restricted share units and ESPP shares were excluded from the calculation of diluted loss per share, as their effect would have been anti-dilutive. |
Share-Based Compensation Expens
Share-Based Compensation Expense | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation Expense | Share-Based Compensation Expense 2016 Share Option and Incentive Plan In January 2016, in connection with the Company's initial public offering ("IPO") on the Nasdaq Stock Market, the board of directors and shareholders of the Company approved the 2016 Share Option and Incentive Plan (the “2016 Plan”), which became effective in February 2016. The Company initially reserved 65,029,595 ordinary shares for the issuance of awards under the 2016 Plan, plus any shares available under the 2011 Option Plan (the “2011 Plan”), and not subject to any outstanding options as of the effective date of the 2016 Plan, along with underlying share awards under the 2011 Plan that are cancelled or forfeited without issuance of ordinary shares. As of September 30, 2022, ordinary shares cancelled or forfeited under the 2011 Plan that were carried over to the 2016 Plan totaled 5,166,627. In December 2018, the shareholders approved an amended and restated 2016 Plan to increase the number of shares authorized for issuance by 38,553,159 ordinary shares, as well as amend the cap on annual compensation to independent directors and make other changes. In June 2020, the shareholders approved an Amendment No. 1 to the 2016 Plan to increase the number of shares authorized for issuance by 57,200,000 ordinary shares and to extend the term of the plan through April 13, 2030. The number of shares available for issuance under the 2016 Plan is subject to adjustment in the event of a share split, share dividend or other change in the Company’s capitalization. During the nine months ended September 30, 2022, the Company granted options for 12,437,373 ordinary shares and restricted share units for 37,043,877 ordinary shares under the 2016 Plan. As of September 30, 2022, options and restricted share units for ordinary shares outstanding under the 2016 Plan totaled 63,928,723 and 56,502,940, respectively. As of September 30, 2022, share-based awards to acquire 74,429,673 ordinary shares were available for future grant under the 2016 Plan. In order to continue to provide incentive opportunities under the 2016 Plan, the Board of Directors and shareholders of the Company approved an amendment to the 2016 Plan (the "Amendment No. 2"), which became effective as of June 22, 2022, to increase the number of authorized shares available for issuance under the 2016 Plan by 66,300,000 ordinary shares, or 5% of the Company's outstanding shares as of March 31, 2022. 2018 Inducement Equity Plan In June 2018, the board of directors of the Company approved the 2018 Inducement Equity Plan (the "2018 Plan") and reserved 12,000,000 ordinary shares to be used exclusively for grants of awards to individuals that were not previously employees of the Company or its subsidiaries, as a material inducement to the individual’s entry into employment with the Company or its subsidiaries within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The 2018 Plan was approved by the board of directors upon recommendation of the compensation committee, without shareholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. The terms and conditions of the 2018 Plan, and the forms of award agreements to be used thereunder, are substantially similar to the 2016 Plan and the forms of award agreements thereunder. In August 2018, in connection with the Hong Kong IPO, the board of directors of the Company approved an amended and restated 2018 Plan to implement changes required by the listing rules of the Stock Exchange of Hong Kong Limited ("HKEX"). During the nine months ended September 30, 2022, the Company did not grant any options or restricted share units under the 2018 Plan. As of September 30, 2022, options and restricted share units for ordinary shares outstanding under the 2018 Plan totaled 27,846 and 223,028, respectively. Upon the effectiveness of Amendment No. 2 to the 2016 Plan, on June 22, 2022, the 2018 Plan was terminated to the effect that no new equity awards shall be granted under the plan but the outstanding equity awards under the plan shall continue to vest and/or be exercisable in accordance with their terms. 2018 Employee Share Purchase Plan In June 2018, the shareholders of the Company approved the 2018 Employee Share Purchase Plan (the “ESPP”). Initially, 3,500,000 ordinary shares of the Company were reserved for issuance under the ESPP. In December 2018, the board of directors of the Company approved an amended and restated ESPP to increase the number of shares authorized for issuance by 3,855,315 ordinary shares to 7,355,315 ordinary shares. In June 2019, the board of directors adopted an amendment to revise the eligibility criteria for enrollment in the plan. In June 2021, the board of directors of the Company adopted the third amended and restated ESPP to include certain technical amendments under U.S. tax rules and to consolidate the changes in the prior amendment, effective on September 1, 2021. The ESPP allows eligible employees to purchase the Company’s ordinary shares (including in the form of ADSs) at the end of each offering period, which will generally be six months, at a 15% discount to the market price of the Company’s ADSs at the beginning or the end of each offering period, whichever is lower, using funds deducted from their payroll during the offering period. Eligible employees are able to authorize payroll deductions of up to 10% of their eligible earnings, subject to applicable limitations. As of September 30, 2022, 3,666,071 ordinary shares were available for future issuance under the ESPP. The following tables summarizes the shares issued under the ESPP: Market Price 1 Purchase Price 2 Issuance Date Number of Ordinary Shares Issued ADS Ordinary ADS Ordinary Proceeds August 31, 2022 861,315 $ 171.66 $ 13.20 $ 145.91 $ 11.22 $ 9,667 February 28, 2022 667,160 $ 210.52 $ 16.19 $ 178.94 $ 13.76 $ 9,183 August 31, 2021 425,386 $ 308.30 $ 23.72 $ 262.06 $ 20.16 $ 8,575 February 26, 2021 436,124 $ 236.30 $ 18.18 $ 200.86 $ 15.45 $ 6,738 1 The market price is the lower of the closing price on the Nasdaq Stock Market on the issuance date or the offering date, in accordance with the terms of the ESPP. 2 The purchase price is the price which was discounted from the applicable market price, in accordance with the terms of the ESPP. The following table summarizes total share-based compensation expense recognized for the three and nine months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ Research and development 36,417 31,680 104,382 83,762 Selling, general and administrative 41,759 35,397 120,654 93,939 Total 78,176 67,077 225,036 177,701 |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income (Loss) | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Accumulated Other Comprehensive Income (Loss) | Accumulated Other Comprehensive Income (Loss) The movement of accumulated other comprehensive income (loss) was as follows: Unrealized Foreign Currency Gains/(Losses) on Pension Translation Available-for-Sale Liability Adjustments Securities Adjustments Total $ $ $ $ Balance as of December 31, 2021 27,898 (3,700) (6,248) 17,950 Other comprehensive loss before reclassifications (168,411) (11,062) — (179,473) Amounts reclassified from accumulated other comprehensive income (loss) — — — — Net-current period other comprehensive loss (168,411) (11,062) — (179,473) Balance as of September 30, 2022 (140,513) (14,762) (6,248) (161,523) |
Shareholders_ Equity
Shareholders’ Equity | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Shareholders’ Equity | Shareholders’ Equity Share Purchase Agreement In September 2021, the Company issued an aggregate of 165,529 ADSs, representing 2,151,877 ordinary shares, to Amgen for a total consideration of $50,000, in a private placement pursuant to a Share Purchase Agreement dated October 31, 2019, as amended on December 6, 2019 and September 24, 2020 by and between Amgen and Company. STAR Offering In December 2021, the Company completed an initial public offering of ("STAR Offering") on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange ("SSE"). The shares offered in the STAR Offering were issued to and subscribed for by permitted investors in the People’s Republic of China ("PRC") in Renminbi ("RMB Shares"). The public offering price of the RMB Shares was RMB192.60 per ordinary share, or $391.68 per ADS. In this offering, the Company sold 115,055,260 ordinary shares. Net proceeds after deducting underwriting discounts and commission and offering expenses were $3,392,616. As required by the PRC securities laws, the net proceeds from the STAR Offering must be used in strict compliance with the planned uses as disclosed in the PRC prospectus as well as the Company's proceeds management policy for the STAR Offering approved by the board of directors. |
Restricted Net Assets
Restricted Net Assets | 9 Months Ended |
Sep. 30, 2022 | |
Restricted Net Assets Disclosure [Abstract] | |
Restricted Net Assets | Restricted Net Assets The Company’s ability to pay dividends may depend on the Company receiving distributions of funds from its PRC subsidiaries. Relevant PRC statutory laws and regulations permit payments of dividends by the Company’s PRC subsidiaries only out of the subsidiary's retained earnings, if any, as determined in accordance with PRC accounting standards and regulations. The results of operations reflected in the condensed consolidated financial statements prepared in accordance with GAAP differ from those reflected in the statutory financial statements of the Company’s PRC subsidiaries. In accordance with the company law of the PRC, a domestic enterprise is required to provide statutory reserves of at least 10% of its annual after-tax profit until such reserve has reached 50% of its respective registered capital based on the enterprise’s PRC statutory accounts. A domestic enterprise is also required to provide discretionary surplus reserve, at the discretion of the board of directors, from the profits determined in accordance with the enterprise’s PRC statutory accounts. The aforementioned reserves can only be used for specific purposes and are not distributable as cash dividends. The Company’s PRC subsidiaries were established as domestic enterprises and therefore are subject to the above-mentioned restrictions on distributable profits. As a result of these PRC laws and regulations, including the requirement to make annual appropriations of at least 10% of after-tax income and set aside as general reserve fund prior to payment of dividends, the Company’s PRC subsidiaries are restricted in their ability to transfer a portion of their net assets to the Company. Foreign exchange and other regulations in the PRC may further restrict the Company's PRC subsidiaries from transferring funds to the Company in the form of dividends, loans and advances. As of September 30, 2022 and December 31, 2021, the net assets of the Company’s PRC subsidiaries amounted to $2,188,139 and $799,574, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Purchase Commitments As of September 30, 2022, the Company had purchase commitments amounting to $142,196, of which $58,342 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $83,854 related to binding purchase obligations of inventory from BMS and Amgen. The Company does not have any minimum purchase requirements for inventory from BMS or Amgen. Capital Commitments The Company had capital commitments amounting to $467,554 for the acquisition of property, plant and equipment as of September 30, 2022, which were mainly for the Company’s manufacturing and clinical R&D campus in Hopewell, NJ, additional capacity at the Guangzhou and Suzhou manufacturing facilities, and new building for Beijing Innerway Bio-tech Co., Ltd. Co-Development Funding Commitment Under the Amgen Collaboration Agreement, the Company is responsible for co-funding global development costs for the Amgen oncology pipeline assets up to a total cap of $1,250,000. The Company is funding its portion of the co-development costs by contributing cash and development services. As of September 30, 2022, the Company's remaining co-development funding commitment was $648,419. Research and Development Commitment The Company entered into a long-term research and development agreement in June 2021, which includes obligations to make an upfront payment and fixed quarterly payments over the next four years. As of September 30, 2022, the total research and development commitment amounted to $23,775. Funding Commitment The Company had committed capital related to two equity method investments in the amount of $19,000. As of September 30, 2022, the remaining capital commitment was $16,000 and is expected to be paid from time to time over the investment period. Pension Commitment The Company maintains a defined benefit pension plan in Switzerland. Funding obligations under the defined benefit pension plan are equivalent to $1,505 per year based on annual funding contributions in effect as of September 30, 2022 to achieve fully funded status where the market value of plan assets equals the projected benefit obligations. Future funding requirements will be subject to change as a result of future changes in staffing and compensation levels, various actuarial assumptions and actual investment returns on plan assets. Other Business Agreements The Company enters into agreements in the ordinary course of business with contract research organizations ("CROs") to provide research and development services. These contracts are generally cancellable at any time by us with prior written notice. The Company also enters into collaboration agreements with institutions and companies to license intellectual property. The Company may be obligated to make future development, regulatory and commercial milestone payments and royalty payments on future sales of specified products associated with its collaboration agreements. Payments under these agreements |
Segment and Geographic Informat
Segment and Geographic Information | 9 Months Ended |
Sep. 30, 2022 | |
Segment Reporting [Abstract] | |
Segment and Geographic Information | Segment and Geographic Information The Company operates in one segment: pharmaceutical products. Its chief operating decision maker is the Chief Executive Officer, who makes operating decisions, assesses performance and allocates resources on a consolidated basis. The Company’s long-lived assets are primarily located in the PRC and the U.S. Net product revenues by geographic area are based upon the location of the customer, and net collaboration revenue is recorded in the jurisdiction in which the related income is expected to be sourced from. Total net revenues by geographic area are presented as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ PRC 233,274 158,775 636,438 377,392 United States 134,789 43,471 348,538 427,280 Rest of world 19,565 4,194 50,850 157,632 Total 387,628 206,440 1,035,826 962,304 PRC revenues consisted primarily of product revenues for the three and nine months ended September 30, 2022 and 2021. U.S. revenues for the three and nine months ended September 30, 2022 consisted of collaboration revenue of $26,685 and $84,165, respectively, and BRUKINSA ® product sales of $108,104 and $264,373, respectively. U.S. revenues for the three and nine months ended September 30, 2021 consisted of collaboration revenue of $9,785 and $367,571, respectively, and BRUKINSA ® product sales of $33,686 and $59,709 respectively. Rest of world revenues for the three and nine months ended September 30, 2022 consisted of collaboration revenue of $11,437 and $36,071, respectively, and BRUKINSA ® product sales of $8,128 and $14,779, respectively. Rest of world revenues consisted entirely of collaboration revenues for the three and nine months ended September 30, 2021. |
Description of Business, Basi_2
Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of presentation and consolidation | Basis of presentation and consolidation The accompanying condensed consolidated balance sheet as of September 30, 2022, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2022 and 2021, the condensed consolidated statements of cash flows for the nine months ended September 30, 2022 and 2021, and the condensed consolidated statements of shareholders' equity for the three and nine months ended September 30, 2022 and 2021, and the related footnote disclosures are unaudited. The accompanying unaudited interim condensed financial statements were prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), including guidance with respect to interim financial information and in conformity with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for annual financial statements. These financial statements should be read in conjunction with the consolidated financial statements and related footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (the "Annual Report"). The unaudited interim condensed consolidated interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all normal recurring adjustments, necessary to present a fair statement of the results for the interim periods presented. Results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results expected for the full fiscal year or for any future annual or interim period. |
Use of estimates | Use of estimates The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Areas where management uses subjective judgment include, but are not limited to, estimating the useful lives of long-lived assets, estimating variable consideration in product sales and collaboration revenue arrangements, identifying separate accounting units and determining the standalone selling price of each performance obligation in the Company’s revenue arrangements, assessing the impairment of long-lived assets, valuation and recognition of share-based compensation expenses, realizability of deferred tax assets, estimating uncertain tax positions, valuation of inventory, estimating the allowance for credit losses, determining defined benefit pension plan obligations, measurement of right-of-use assets and lease liabilities and the fair value of financial instruments. Management bases the estimates on historical experience, known trends and various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities and reported amounts of revenues and expenses. Actual results could differ from these estimates. |
Revision of prior period financial statements | Revision of prior period financial statements The Company evaluates the recoverability of its deferred tax assets on a jurisdiction-by-jurisdiction basis by assessing the adequacy of future expected taxable income from all sources, including reversal of temporary differences, forecasted operating earnings and available tax planning strategies in accordance with ASC 740. This assessment is subject to a high degree of subjectivity, as the sources of income rely heavily on estimates that are based on a number of factors, including historical experience and short-range and long-range business forecasts. A valuation allowance is provided when the Company determines that it is more-likely-than-not that some portion or all of a deferred tax asset will not be realized. Prior to the third quarter of 2022, the Company determined that the majority of its net deferred tax assets (primarily in the U.S.) were realizable on a more-likely-than-not basis, primarily due to cumulative pre-tax income at the taxpaying entity and the weighting of available positive and negative evidence. Accordingly, no valuation allowance was previously recorded related to those deferred tax assets. In October 2022, in connection with the preparation of its condensed consolidated financial statements for the three and nine months ended September 30, 2022, the Company reassessed its position on the realizability of its net deferred tax assets and determined that the negative evidence associated with cumulative losses at the consolidated financial statement level are not able to be overcome by other positive evidence, and therefore, a valuation allowance should be applied to its net deferred tax asset balance. The Company determined the previous conclusion to not apply a valuation allowance to certain net deferred tax assets was an error. In accordance with Staff Accounting Bulletin (SAB) No. 99, “Materiality,” and SAB No. 108, “Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements,” the Company evaluated the error and determined that the related impact was not material to any of its previously issued financial statements, but that correcting the cumulative impact of the error would be significant to its statements of operations for the three and nine months ended September 30, 2022. Accordingly, the Company has revised the first and second quarters of 2022 and the quarterly and annual periods of fiscal year 2021 condensed consolidated financial statements and related notes included herein to record a valuation allowance against the Company’s net deferred tax asset balance for all periods presented. A summary of revisions to previously reported financial statements is presented in Note 2, Revision of Prior Period Financial Statements. Note 9, Income Taxes and Note 13, Loss Per Share have been updated to reflect the revision. The Company will also correct previously reported financial information for this error in its future filings, as applicable. |
Recent accounting pronouncements | Recent accounting pronouncements New accounting standards which have not yet been adopted In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance . This update requires certain annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy. This update is effective for annual periods beginning after December 15, 2021, and early application is permitted. This guidance should be applied either prospectively to all transactions that are reflected in financial statements at the date of initial application and new transactions that are entered into after the date of initial application or retrospectively to those transactions. The Company does not expect the adoption of this guidance to have a material impact on the Company’s consolidated financial statements. Significant accounting policies For a more complete discussion of the Company’s significant accounting policies and other information, the unaudited interim condensed consolidated financial statements and notes thereto should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2021. |
Revision of Prior Period Fina_2
Revision of Prior Period Financial Statements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Changes and Error Corrections [Abstract] | |
Schedule of Effect of Correcting these Accounting Errors | Condensed Consolidated Balance Sheet (unaudited) As of December 31, 2021 As Reported Adjustments As Revised $ $ $ Deferred tax assets 110,424 (110,424) — Total non-current assets 1,032,069 (110,424) 921,645 Total assets 8,645,949 (110,424) 8,535,525 Accumulated deficit (4,966,103) (110,424) (5,076,527) Total equity 6,242,987 (110,424) 6,132,563 Total liabilities and equity 8,645,949 (110,424) 8,535,525 Condensed Consolidated Statements of Operations (unaudited) Three Months Ended Nine Months Ended September 30, 2021 September 30, 2021 As Reported Adjustments As Revised As Reported Adjustments As Revised $ $ $ $ $ $ Income tax expense (benefit) (19,223) 24,259 5,036 (24,083) 39,437 15,354 Net loss (413,855) (24,259) (438,114) (827,701) (39,437) (867,138) Net loss per share (0.34) (0.02) (0.36) (0.69) (0.03) (0.72) Net loss per American Depositary Share ("ADS") (4.46) (0.26) (4.72) (8.99) (0.43) (9.42) Condensed Consolidated Statements of Comprehensive Loss (unaudited) Three Months Ended Nine Months Ended September 30, 2021 September 30, 2021 As Reported Adjustments As Revised As Reported Adjustments As Revised $ $ $ $ $ $ Net loss (413,855) (24,259) (438,114) (827,701) (39,437) (867,138) Comprehensive loss (413,370) (24,259) (437,629) (822,063) (39,437) (861,500) Condensed Consolidated Statement of Cash Flows (unaudited) Nine Months Ended September 30, 2021 As Reported Adjustments As Revised $ $ $ Operating activities: Net loss (827,701) (39,437) (867,138) Adjustments to reconcile net loss to net cash used in operating activities: Deferred income tax benefits (38,408) 40,882 2,474 Changes in operating assets and liabilities: Other assets (92,938) 449 (92,489) Accrued expenses and other payables 819 (863) (44) Other liabilities 3,438 (1,031) 2,407 Net cash used in operating activities (790,884) — (790,884) Condensed Consolidated Statement of Stockholders' Equity (unaudited) Accumulated Deficit Total Equity As Reported Adjustments As Revised As Reported Adjustments As Revised $ $ $ $ $ $ Balance at December 31, 2021 (4,966,103) (110,424) (5,076,527) 6,242,987 (110,424) 6,132,563 Net loss (434,274) (924) (435,198) (434,274) (924) (435,198) Balance at March 31, 2022 (5,400,377) (111,348) (5,511,725) 5,885,500 (111,348) 5,774,152 Net loss (571,449) 5,723 (565,726) (571,449) 5,723 (565,726) Balance at June 30, 2022 (5,971,826) (105,625) (6,077,451) 5,302,544 (105,625) 5,196,919 Balance at December 31, 2020 (3,552,749) (65,962) (3,618,711) 3,869,243 (65,962) 3,803,281 Net income 66,495 (10,915) 55,580 66,495 (10,915) 55,580 Balance at March 31, 2021 (3,486,254) (76,877) (3,563,131) 4,003,587 (76,877) 3,926,710 Net loss (480,341) (4,263) (484,604) (480,341) (4,263) (484,604) Balance at June 30, 2021 (3,966,595) (81,140) (4,047,735) 3,606,775 (81,140) 3,525,635 Net loss (413,855) (24,259) (438,114) (413,855) (24,259) (438,114) Balance at September 30, 2021 (4,380,450) (105,399) (4,485,849) 3,357,073 (105,399) 3,251,674 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of assets and liabilities measured at fair value on a recurring basis | The following tables present the Company’s financial assets and liabilities measured and recorded at fair value on a recurring basis using the above input categories as of September 30, 2022 and December 31, 2021: Quoted Price in Active Market for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs As of September 30, 2022 (Level 1) (Level 2) (Level 3) $ $ $ Cash equivalents U.S. Treasury securities 123,519 — — Money market funds 373,370 — — Short-term investments (Note 5): U.S. Treasury securities 871,998 — — Other non-current assets (Note 5): Equity securities with readily determinable fair values 6,467 2,037 — Convertible debt instrument — — 5,000 Total 1,375,354 2,037 5,000 Quoted Price in Active Market for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs As of December 31, 2021 (Level 1) (Level 2) (Level 3) $ $ $ Cash equivalents U.S. Treasury securities 107,855 — — Money market funds 315,564 — — Short-term investments (Note 5): U.S. Treasury securities 2,241,962 — — Other non-current assets (Note 5): Equity securities with readily determinable fair values 23,809 10,306 — Total 2,689,190 10,306 — |
Collaborative and Licensing A_2
Collaborative and Licensing Arrangements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Research and Development [Abstract] | |
Schedule of Net Product Sales | The following table summarizes total collaboration revenue recognized for the three and nine months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Revenue from Collaborators $ $ $ $ License revenue — — — 484,646 Research and development service revenue 9,834 13,979 34,074 40,456 Right to access intellectual property revenue 26,249 — 78,746 — Other 2,039 — 7,416 — Total 38,122 13,979 120,236 525,102 The table below presents the Company’s net product sales for the three and nine months ended September 30, 2022 and 2021. Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ Product revenue – gross 398,379 206,029 1,036,652 497,823 Less: Rebates and sales returns (48,873) (13,568) (121,062) (60,621) Product revenue – net 349,506 192,461 915,590 437,202 The following table disaggregates net product sales by product for the three and nine months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ BRUKINSA ® 155,495 65,832 388,567 130,345 Tislelizumab 128,206 76,980 320,728 200,738 REVLIMID ® 19,046 20,209 60,622 46,984 XGEVA ® 18,148 15,699 47,156 33,491 POBEVCY ® 9,873 — 29,671 — KYPROLIS ® 2,820 — 11,225 — BLINCYTO ® 6,214 5,040 27,610 5,040 VIDAZA ® 3,314 5,810 12,260 12,771 Pamiparib 1,266 1,516 5,843 3,737 Other 5,124 1,375 11,908 4,096 Total product revenue – net 349,506 192,461 915,590 437,202 |
Schedule of Collaboration Agreements | Amounts recorded related to the Company's portion of the co-development funding on the pipeline assets for the three and nine months ended September 30, 2022 and 2021 were as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ Research and development expense 25,462 29,710 72,251 85,040 Amortization of research and development cost share liability 24,806 28,943 70,389 82,846 Total amount due to Amgen for BeiGene's portion of the development funding 50,268 58,653 142,640 167,886 As of September 30, 2022 Remaining portion of development funding cap 648,419 As of September 30, 2022 and December 31, 2021, the research and development cost share liability recorded in the Company's balance sheet was as follows: As of September 30, December 31, 2022 2021 $ $ Research and development cost share liability, current portion 115,721 120,801 Research and development cost share liability, non-current portion 204,252 269,561 Total research and development cost share liability 319,973 390,362 |
Schedule of Amounts and Classification of Reimbursement Expense | The total reimbursement due under the commercial profit-sharing agreement for product sales is classified in the income statement for the three and nine months ended September 30, 2022 and 2021 as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ Cost of sales - product 319 380 3,797 1,058 Research and development (1,125) (373) (227) (310) Selling, general and administrative (13,854) (12,552) (40,496) (28,469) Total (14,660) (12,545) (36,926) (27,721) |
Restricted Cash and Investmen_2
Restricted Cash and Investments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Short-Term Investments | Short-term investments as of September 30, 2022 consisted of the following available-for-sale debt securities: Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) $ $ $ $ U.S. Treasury securities 883,126 — 11,128 871,998 Total 883,126 — 11,128 871,998 Short-term investments as of December 31, 2021 consisted of the following available-for-sale debt securities: Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) $ $ $ $ U.S. Treasury securities 2,245,662 — 3,700 2,241,962 Total 2,245,662 — 3,700 2,241,962 |
Schedule of Fair Value of the Common Stock and Warrants | As of September 30, 2022 and December 31, 2021, the fair value of the common stock and warrants was as follows: As of September 30, December 31, 2022 2021 $ $ Fair value of Leap common stock 6,467 23,809 Fair value of Leap warrants 2,037 10,306 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | The Company’s inventory balance consisted of the following: As of September 30, December 31, 2022 2021 $ $ Raw materials 88,953 78,140 Work in process 22,737 9,397 Finished goods 179,221 155,089 Total inventories 290,911 242,626 |
Property, plant and equipment (
Property, plant and equipment (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Components of Property, Plant and Equipment | Property, plant and equipment are recorded at cost and consisted of the following: As of September 30, December 31, 2022 2021 $ $ Land 65,485 65,485 Laboratory equipment 137,990 118,203 Leasehold improvements 50,005 50,288 Building 170,243 144,083 Manufacturing equipment 147,433 119,585 Software, electronics and office equipment 38,257 27,404 Property, plant and equipment, at cost 609,413 525,048 Less: accumulated depreciation (149,692) (124,286) Construction in progress 222,193 186,843 Property, plant and equipment, net 681,914 587,605 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets Outstanding and Amortization Expense | Intangible assets as of September 30, 2022 and December 31, 2021 are summarized as follows: As of September 30, 2022 December 31, 2021 Gross Gross carrying Accumulated Intangible carrying Accumulated Intangible amount amortization assets, net amount amortization assets, net $ $ $ $ $ $ Finite-lived intangible assets: Product distribution rights 7,500 (3,813) 3,687 7,500 (3,250) 4,250 Developed product 40,432 (3,270) 37,162 43,394 (965) 42,429 Trading license 816 (816) — 816 (816) — Total finite-lived intangible assets 48,748 (7,899) 40,849 51,710 (5,031) 46,679 Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ Amortization expense - Cost of sales - product 800 216 2,444 333 Amortization expense - Operating expense 187 188 563 563 987 404 3,007 896 |
Schedule of Finite-Lived Intangible Assets Amortization Expense | Estimated amortization expense for each of the five succeeding years and thereafter, as of September 30, 2022 is as follows: Year Ending December 31, Cost of Sales - Product Operating Expenses Total $ $ $ 2022 (remainder of year) 779 188 967 2023 3,117 750 3,867 2024 3,117 750 3,867 2025 3,117 750 3,867 2026 3,117 750 3,867 2027 and thereafter 23,915 499 24,414 Total 37,162 3,687 40,849 |
Supplemental Balance Sheet In_2
Supplemental Balance Sheet Information (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Allowance for Credit Loss Rollforward | The roll-forward of the allowance for credit losses related to trade accounts receivable for the nine months ended September 30, 2022 and 2021 consists of the following activity: Nine Months Ended September 30, 2022 2021 $ $ Balance at beginning of the period 415 112 Current period provision for expected credit losses (161) (7) Amounts written-off — — Exchange rate changes (2) 3 Balance at end of the period 252 108 |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following: As of September 30, December 31, 2022 2021 $ $ Prepaid research and development costs 74,575 87,239 Prepaid manufacturing cost 60,971 78,538 Prepaid taxes 11,494 58,579 Other receivables 11,272 12,010 Interest receivable 2,203 5,052 Prepaid insurance 6,465 1,695 Short-term deposit 10,917 2,982 Other current assets 21,869 24,078 Total 199,766 270,173 |
Schedule of Other Non-Current Assets | Other non-current assets consist of the following: As of September 30, December 31, 2022 2021 $ $ Goodwill 109 109 Prepayment of property and equipment 17,951 14,140 Prepayment of facility capacity expansion activities (1) 19,676 24,237 Prepaid VAT 217 17,162 Rental deposits and other 6,520 6,609 Long-term investments 96,080 100,792 Total 140,553 163,049 (1) Represents payments for facility expansions under commercial supply agreements. The payments are providing future benefit to the Company through credits on commercial supply purchases. |
Schedule of Accrued Expenses and Other Payables | Accrued expenses and other payables consist of the following: As of September 30, December 31, 2022 2021 $ $ Compensation related 142,837 139,966 External research and development activities related 114,008 213,922 Commercial activities 34,646 71,560 Employee tax withholdings 25,879 45,661 Sales rebates and returns related 49,890 59,639 Professional fees and other 42,995 27,307 Total 410,255 558,055 |
Schedule of Other Long-Term Liabilities | Other long-term liabilities consist of the following: As of September 30, December 31, 2022 2021 $ $ Deferred government grant income 37,700 46,352 Pension liability 7,330 7,814 Other 139 68 Total 45,169 54,234 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Summary of Short-Term and Long-Term Debt Obligations | The following table summarizes the Company's short-term and long-term debt obligations as of September 30, 2022 and December 31, 2021: Lender Agreement Date Line of Credit Term Maturity Date Interest Rate As of September 30, 2022 December 31, 2021 $ RMB $ RMB China Construction Bank April 4, 2018 RMB580,000 9-year April 4, 2027 (1) 4,077 29,000 1,255 8,000 China Merchants Bank January 22, 2020 (2) 9-year January 20, 2029 (2) 1,406 10,000 1,569 10,000 China Merchants Bank November 9, 2020 RMB378,000 9-year November 8, 2029 (3) 3,866 27,500 — — China Minsheng Bank (the "Senior Loan") September 24, 2020 $200,000 (4) 4.5 % 200,000 1,422,677 200,000 1,274,535 Zhuhai Hillhouse (the "Related Party Loan") September 24, 2020 RMB500,000 (5) 4.5 % 14,058 100,000 15,693 100,000 Shanghai Pudong Development Bank February 25, 2022 $50,000 1-year February 25, 2023 2.2 % 50,000 355,669 — — Other short-term debt (6) 167,868 1,194,115 209,048 1,332,197 Total short-term debt 441,275 3,138,961 427,565 2,724,732 China Construction Bank April 4, 2018 RMB580,000 9-year April 4, 2027 (1) 76,616 545,000 89,444 570,000 China Merchants Bank January 22, 2020 (2) 9-year January 20, 2029 (2) 49,273 350,500 53,353 340,000 China Merchants Bank November 9, 2020 RMB378,000 9-year November 8, 2029 (3) 46,743 332,500 59,316 378,000 China CITIC Bank July 29, 2022 RMB480,000 10-year July 28, 2032 (7) 35,426 252,000 — — Total long-term bank loans 208,058 1,480,000 202,113 1,288,000 1. The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC. The loan interest rate was 4.9% as of September 30, 2022. The loan is secured by BeiGene Guangzhou Factory's land use right and certain Guangzhou Factory fixed assets in the first phase of the Guangzhou manufacturing facility's build out. The Company repaid $598(RMB4,000) during the nine months ended September 30, 2022. 2. On January 22, 2020, BeiGene Guangzhou Biologics Manufacturing Co., Ltd.("BeiGene Guangzhou Factory") entered into a nine-year bank loan with China Merchants Bank to borrow up to RMB1,100,000 at a floating interest rate benchmarked against prevailing interest rates of certain PRC financial institutions. The loan is secured by Guangzhou Factory's second land use right and fixed assets placed into service upon completion of the second phase of the Guangzhou manufacturing facility's build out. In connection with the Company's short-term loan agreements with China Merchants Bank entered into during the year ended December 31, 2020, the borrowing capacity was reduced from RMB1,100,000 to RMB350,000. The loan interest rate was 4.4% as of September 30, 2022. The Company repaid $1,142 (RMB7,500) during the nine months ended September 30, 2022. BeiGene Guangzhou Biologics Manufacturing Co., Ltd. is a company incorporated under the laws of the PRC on March 3, 2017 and a wholly owned subsidiary of BeiGene Biologics. 3. The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC. The loan interest rate was 4.3% as of September 30, 2022. The loan is secured by fixed assets placed into service upon completion of the third phase of the Guangzhou manufacturing facility's build out. 4. In September 2020, the Company entered into a loan agreement with China Minsheng Bank for a total loan facility of up to $200,000 ("Senior Loan"), of which $120,000 was designated to fund the purchase of noncontrolling equity interest in BeiGene Biologics Co., Ltd. ("BeiGene Biologics") from Guangzhou GET Technology Development Co., Ltd. (now Guangzhou High-tech Zone Technology Holding Group Co., Ltd.) ("GET") and repayment of the loan provided by GET ("Shareholder Loan") and $80,000 was designated for general working capital purposes. The Senior Loan had an original maturity date of October 8, 2021, which was the first anniversary of the first date of utilization of the loan. The Company may extend the original maturity date for up to two additional 12 month periods. On October 8, 2021, the Company extended the maturity date for twelve months to October 8, 2022 and repurposed the Senior Loan for general working capital purposes. BeiGene Biologics Co., Ltd. is a company incorporated under the laws of the PRC on January 25, 2017 and an indirectly wholly owned subsidiary of the Company. 5. In September 2020, the Company entered into a loan agreement with Zhuhai Hillhouse Zhaohui Equity Investment Partnership (Zhuhai Hillhouse) for a total loan facility of $73,640 (RMB500,000) ("Related Party Loan"), of which $14,728 (RMB100,000) can be used for general corporate purposes and $58,912 (RMB400,000) can only be applied towards the repayment of the Senior Loan facility, including principal, interest and fees. The loan maturity was the earlier of: (i) November 9, 2021, which is one month after the Senior Loan maturity date, if not extended, or (ii) 10 business days after the Senior Loan is fully repaid. On October 8, 2021, the Company extended the maturity date of the Related Party Loan to the earlier of: (i) November 9, 2022, which is one month after the Senior Loan maturity date, if not extended, or (ii) 10 business days after the Senior Loan is fully repaid. Zhuhai Hillhouse is a related party of the Company, as it is an affiliate of Hillhouse Capital. Hillhouse Capital is a shareholder of the Company, and a Hillhouse Capital employee is a member of the Company's board of directors. 6. During the nine months ended September 30, 2022 and the years ended December 31, 2021 and 2020, the Company entered into additional short-term working capital loans with China Industrial Bank and China Merchants Bank to borrow up to RMB2,435,000 in aggregate, with maturity dates ranging from January 19, 2021 to September 18, 2023. The Company drew down $113,774 (RMB792,000) and repaid $143,688 (RMB930,082) of the short-term loans in the nine months ended September 30, 2022. The weighted average interest rate for the short-term working capital loans was approximately 3.1% as of September 30, 2022. 7. In July 2022, the Company entered into a 10-year bank loan agreement with China CITIC Bank to borrow up to RMB480,000 at a floating interest rate benchmarked against prevailing interest rates of certain PRC financial institutions. The loan interest rate was 4.2% as of September 30, 2022. The loan is secured by BeiGene Suzhou Co., Ltd.'s land use right. The Company drew down $37,372(RMB252,000) during the nine months ended September 30, 2022. |
Product Revenue (Tables)
Product Revenue (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Net Product Sales | The following table summarizes total collaboration revenue recognized for the three and nine months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Revenue from Collaborators $ $ $ $ License revenue — — — 484,646 Research and development service revenue 9,834 13,979 34,074 40,456 Right to access intellectual property revenue 26,249 — 78,746 — Other 2,039 — 7,416 — Total 38,122 13,979 120,236 525,102 The table below presents the Company’s net product sales for the three and nine months ended September 30, 2022 and 2021. Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ Product revenue – gross 398,379 206,029 1,036,652 497,823 Less: Rebates and sales returns (48,873) (13,568) (121,062) (60,621) Product revenue – net 349,506 192,461 915,590 437,202 The following table disaggregates net product sales by product for the three and nine months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ BRUKINSA ® 155,495 65,832 388,567 130,345 Tislelizumab 128,206 76,980 320,728 200,738 REVLIMID ® 19,046 20,209 60,622 46,984 XGEVA ® 18,148 15,699 47,156 33,491 POBEVCY ® 9,873 — 29,671 — KYPROLIS ® 2,820 — 11,225 — BLINCYTO ® 6,214 5,040 27,610 5,040 VIDAZA ® 3,314 5,810 12,260 12,771 Pamiparib 1,266 1,516 5,843 3,737 Other 5,124 1,375 11,908 4,096 Total product revenue – net 349,506 192,461 915,590 437,202 |
Schedule of Accrued Sales Rebates and Returns | The following table presents the roll-forward of accrued sales rebates and returns for the nine months ended September 30, 2022 and 2021: Nine Months Ended September 30, 2022 2021 $ $ Balance at beginning of the period 59,639 11,874 Accrual 121,062 60,621 Payments (130,811) (52,305) Balance at end of the period 49,890 20,190 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of the Computations of Basic and Diluted Loss Per Share | The following table reconciles the numerator and denominator in the computations of basic and diluted loss per share: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ Numerator: Net loss (557,556) (438,114) (1,558,480) (867,138) Denominator: Weighted average shares outstanding—basic and diluted 1,345,303,747 1,205,971,284 1,337,976,853 1,196,391,201 |
Share-Based Compensation Expe_2
Share-Based Compensation Expense (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Shares Issued Under Employee Share Purchase Plan | The following tables summarizes the shares issued under the ESPP: Market Price 1 Purchase Price 2 Issuance Date Number of Ordinary Shares Issued ADS Ordinary ADS Ordinary Proceeds August 31, 2022 861,315 $ 171.66 $ 13.20 $ 145.91 $ 11.22 $ 9,667 February 28, 2022 667,160 $ 210.52 $ 16.19 $ 178.94 $ 13.76 $ 9,183 August 31, 2021 425,386 $ 308.30 $ 23.72 $ 262.06 $ 20.16 $ 8,575 February 26, 2021 436,124 $ 236.30 $ 18.18 $ 200.86 $ 15.45 $ 6,738 1 The market price is the lower of the closing price on the Nasdaq Stock Market on the issuance date or the offering date, in accordance with the terms of the ESPP. 2 The purchase price is the price which was discounted from the applicable market price, in accordance with the terms of the ESPP. |
Summary of Total Compensation Cost Recognized | The following table summarizes total share-based compensation expense recognized for the three and nine months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ Research and development 36,417 31,680 104,382 83,762 Selling, general and administrative 41,759 35,397 120,654 93,939 Total 78,176 67,077 225,036 177,701 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Loss) (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Schedule of Accumulated Other Comprehensive Income (Loss) | The movement of accumulated other comprehensive income (loss) was as follows: Unrealized Foreign Currency Gains/(Losses) on Pension Translation Available-for-Sale Liability Adjustments Securities Adjustments Total $ $ $ $ Balance as of December 31, 2021 27,898 (3,700) (6,248) 17,950 Other comprehensive loss before reclassifications (168,411) (11,062) — (179,473) Amounts reclassified from accumulated other comprehensive income (loss) — — — — Net-current period other comprehensive loss (168,411) (11,062) — (179,473) Balance as of September 30, 2022 (140,513) (14,762) (6,248) (161,523) |
Segment and Geographic Inform_2
Segment and Geographic Information (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Segment Reporting [Abstract] | |
Schedule of Net Product Revenues by Geographic Area | Total net revenues by geographic area are presented as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 $ $ $ $ PRC 233,274 158,775 636,438 377,392 United States 134,789 43,471 348,538 427,280 Rest of world 19,565 4,194 50,850 157,632 Total 387,628 206,440 1,035,826 962,304 |
Description of Business, Basi_3
Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies (Details) patient in Thousands, employee in Thousands | Sep. 30, 2022 employee country people trial application product patient |
Organization | |
Number of people (person) | people | 2,500 |
Product candidate (candidate) | product | 3 |
Number of employees (employee) | employee | 9 |
Number of countries which entity operates (country) | country | 29 |
Product distribution rights | |
Organization | |
Approved medicines (medicine) | application | 13 |
Minimum | |
Organization | |
Planned clinical trial (trial) | 80 |
Products on trial (trial) | 30 |
Number of patients (patient) | patient | 16 |
Revision of Prior Period Fina_3
Revision of Prior Period Financial Statements - Condensed Consolidated Balance Sheet (unaudited) (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
New Accounting Pronouncements or Change in Accounting Principle | ||
Deferred tax assets | $ 0 | $ 0 |
Total non-current assets | 976,845 | 921,645 |
Total assets | 6,726,013 | 8,535,525 |
Accumulated deficit | (6,635,007) | (5,076,527) |
Total equity | 4,655,171 | 6,132,563 |
Total liabilities and equity | $ 6,726,013 | 8,535,525 |
As Reported | ||
New Accounting Pronouncements or Change in Accounting Principle | ||
Deferred tax assets | 110,424 | |
Total non-current assets | 1,032,069 | |
Total assets | 8,645,949 | |
Accumulated deficit | (4,966,103) | |
Total equity | 6,242,987 | |
Total liabilities and equity | 8,645,949 | |
Adjustments | ||
New Accounting Pronouncements or Change in Accounting Principle | ||
Deferred tax assets | (110,424) | |
Total non-current assets | (110,424) | |
Total assets | (110,424) | |
Accumulated deficit | (110,424) | |
Total equity | (110,424) | |
Total liabilities and equity | $ (110,424) |
Revision of Prior Period Fina_4
Revision of Prior Period Financial Statements - Condensed Consolidated Statements of Operations (unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
New Accounting Pronouncements or Change in Accounting Principle | ||||
Income tax expense (benefit) | $ 6,318 | $ 5,036 | $ 28,408 | $ 15,354 |
Net loss | $ (557,556) | $ (438,114) | $ (1,558,480) | $ (867,138) |
Net loss per share, basic (in dollars per share) | $ (0.41) | $ (0.36) | $ (1.16) | $ (0.72) |
Net loss per share, diluted (in dollars per share) | (0.41) | (0.36) | (1.16) | (0.72) |
Net loss per American Depositary Share ("ADS") basic (in dollars per share) | (5.39) | (4.72) | (15.14) | (9.42) |
Net loss per American Depositary Share ("ADS") diluted (in dollars per share) | $ (5.39) | $ (4.72) | $ (15.14) | $ (9.42) |
As Reported | ||||
New Accounting Pronouncements or Change in Accounting Principle | ||||
Income tax expense (benefit) | $ (19,223) | $ (24,083) | ||
Net loss | $ (413,855) | $ (827,701) | ||
Net loss per share, basic (in dollars per share) | $ (0.34) | $ (0.69) | ||
Net loss per share, diluted (in dollars per share) | (0.34) | (0.69) | ||
Net loss per American Depositary Share ("ADS") basic (in dollars per share) | (4.46) | (8.99) | ||
Net loss per American Depositary Share ("ADS") diluted (in dollars per share) | $ (4.46) | $ (8.99) | ||
Adjustments | ||||
New Accounting Pronouncements or Change in Accounting Principle | ||||
Income tax expense (benefit) | $ 24,259 | $ 39,437 | ||
Net loss | $ (24,259) | $ (39,437) | ||
Net loss per share, basic (in dollars per share) | $ (0.02) | $ (0.03) | ||
Net loss per share, diluted (in dollars per share) | (0.02) | (0.03) | ||
Net loss per American Depositary Share ("ADS") basic (in dollars per share) | (0.26) | (0.43) | ||
Net loss per American Depositary Share ("ADS") diluted (in dollars per share) | $ (0.26) | $ (0.43) |
Revision of Prior Period Fina_5
Revision of Prior Period Financial Statements - Condensed Consolidated Statements of Comprehensive Loss (unaudited) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
New Accounting Pronouncements or Change in Accounting Principle | ||||
Net loss | $ (557,556) | $ (438,114) | $ (1,558,480) | $ (867,138) |
Comprehensive loss | $ (636,629) | (437,629) | $ (1,737,953) | (861,500) |
As Reported | ||||
New Accounting Pronouncements or Change in Accounting Principle | ||||
Net loss | (413,855) | (827,701) | ||
Comprehensive loss | (413,370) | (822,063) | ||
Adjustments | ||||
New Accounting Pronouncements or Change in Accounting Principle | ||||
Net loss | (24,259) | (39,437) | ||
Comprehensive loss | $ (24,259) | $ (39,437) |
Revision of Prior Period Fina_6
Revision of Prior Period Financial Statements - Condensed Consolidated Statement of Cash Flows (unaudited) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating activities: | ||||
Net loss | $ (557,556) | $ (438,114) | $ (1,558,480) | $ (867,138) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Deferred income tax benefits | 380 | 2,474 | ||
Changes in operating assets and liabilities: | ||||
Other assets | 30,325 | (92,489) | ||
Accrued expenses and other payables | 1,628 | (44) | ||
Other liabilities | 167 | 2,407 | ||
Net cash used in operating activities | $ (1,178,428) | (790,884) | ||
As Reported | ||||
Operating activities: | ||||
Net loss | (413,855) | (827,701) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Deferred income tax benefits | (38,408) | |||
Changes in operating assets and liabilities: | ||||
Other assets | (92,938) | |||
Accrued expenses and other payables | 819 | |||
Other liabilities | 3,438 | |||
Net cash used in operating activities | (790,884) | |||
Adjustments | ||||
Operating activities: | ||||
Net loss | $ (24,259) | (39,437) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Deferred income tax benefits | 40,882 | |||
Changes in operating assets and liabilities: | ||||
Other assets | 449 | |||
Accrued expenses and other payables | (863) | |||
Other liabilities | (1,031) | |||
Net cash used in operating activities | $ 0 |
Revision of Prior Period Fina_7
Revision of Prior Period Financial Statements - Condensed Consolidated Statement of Stockholders' Equity (unaudited) (Details) - USD ($) $ in Thousands | 3 Months Ended | |||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | |
New Accounting Pronouncements or Change in Accounting Principle | ||||||
Balance at the beginning of period | $ 5,196,919 | $ 5,774,152 | $ 6,132,563 | $ 3,525,635 | $ 3,926,710 | $ 3,803,281 |
Net loss | (557,556) | (565,726) | (435,198) | (438,114) | (484,604) | 55,580 |
Balance at the end of period | 4,655,171 | 5,196,919 | 5,774,152 | 3,251,674 | 3,525,635 | 3,926,710 |
Accumulated Deficit | ||||||
New Accounting Pronouncements or Change in Accounting Principle | ||||||
Balance at the beginning of period | (6,077,451) | (5,511,725) | (5,076,527) | (4,047,735) | (3,563,131) | (3,618,711) |
Net loss | (557,556) | (565,726) | (435,198) | (438,114) | (484,604) | 55,580 |
Balance at the end of period | (6,635,007) | (6,077,451) | (5,511,725) | (4,485,849) | (4,047,735) | (3,563,131) |
As Reported | ||||||
New Accounting Pronouncements or Change in Accounting Principle | ||||||
Balance at the beginning of period | 5,302,544 | 5,885,500 | 6,242,987 | 3,606,775 | 4,003,587 | 3,869,243 |
Net loss | (571,449) | (434,274) | (413,855) | (480,341) | 66,495 | |
Balance at the end of period | 5,302,544 | 5,885,500 | 3,357,073 | 3,606,775 | 4,003,587 | |
As Reported | Accumulated Deficit | ||||||
New Accounting Pronouncements or Change in Accounting Principle | ||||||
Balance at the beginning of period | (5,971,826) | (5,400,377) | (4,966,103) | (3,966,595) | (3,486,254) | (3,552,749) |
Net loss | (571,449) | (434,274) | (413,855) | (480,341) | 66,495 | |
Balance at the end of period | (5,971,826) | (5,400,377) | (4,380,450) | (3,966,595) | (3,486,254) | |
Adjustments | ||||||
New Accounting Pronouncements or Change in Accounting Principle | ||||||
Balance at the beginning of period | (105,625) | (111,348) | (110,424) | (81,140) | (76,877) | (65,962) |
Net loss | 5,723 | (924) | (24,259) | (4,263) | (10,915) | |
Balance at the end of period | (105,625) | (111,348) | (105,399) | (81,140) | (76,877) | |
Adjustments | Accumulated Deficit | ||||||
New Accounting Pronouncements or Change in Accounting Principle | ||||||
Balance at the beginning of period | $ (105,625) | (111,348) | (110,424) | (81,140) | (76,877) | (65,962) |
Net loss | 5,723 | (924) | (24,259) | (4,263) | (10,915) | |
Balance at the end of period | $ (105,625) | $ (111,348) | $ (105,399) | $ (81,140) | $ (76,877) |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Assets at fair value on a recurring basis | ||
Short-term investments | $ 871,998 | $ 2,241,962 |
U.S. Treasury securities | ||
Assets at fair value on a recurring basis | ||
Short-term investments | 871,998 | 2,241,962 |
Recurring Basis | Quoted Price in Active Market for Identical Assets (Level 1) | ||
Assets at fair value on a recurring basis | ||
Total | 1,375,354 | 2,689,190 |
Recurring Basis | Quoted Price in Active Market for Identical Assets (Level 1) | U.S. Treasury securities | ||
Assets at fair value on a recurring basis | ||
Short-term investments | 871,998 | 2,241,962 |
Recurring Basis | Quoted Price in Active Market for Identical Assets (Level 1) | Equity securities with readily determinable fair values | ||
Assets at fair value on a recurring basis | ||
Equity securities with readily determinable fair values | 6,467 | 23,809 |
Recurring Basis | Quoted Price in Active Market for Identical Assets (Level 1) | Convertible debt instrument | ||
Assets at fair value on a recurring basis | ||
Convertible debt instrument | 0 | |
Recurring Basis | Quoted Price in Active Market for Identical Assets (Level 1) | U.S. Treasury securities | ||
Assets at fair value on a recurring basis | ||
Cash equivalents | 123,519 | 107,855 |
Recurring Basis | Quoted Price in Active Market for Identical Assets (Level 1) | Money market funds | ||
Assets at fair value on a recurring basis | ||
Cash equivalents | 373,370 | 315,564 |
Recurring Basis | Significant Other Observable Inputs (Level 2) | ||
Assets at fair value on a recurring basis | ||
Total | 2,037 | 10,306 |
Recurring Basis | Significant Other Observable Inputs (Level 2) | U.S. Treasury securities | ||
Assets at fair value on a recurring basis | ||
Short-term investments | 0 | 0 |
Recurring Basis | Significant Other Observable Inputs (Level 2) | Equity securities with readily determinable fair values | ||
Assets at fair value on a recurring basis | ||
Equity securities with readily determinable fair values | 2,037 | 10,306 |
Recurring Basis | Significant Other Observable Inputs (Level 2) | Convertible debt instrument | ||
Assets at fair value on a recurring basis | ||
Convertible debt instrument | 0 | |
Recurring Basis | Significant Other Observable Inputs (Level 2) | U.S. Treasury securities | ||
Assets at fair value on a recurring basis | ||
Cash equivalents | 0 | 0 |
Recurring Basis | Significant Other Observable Inputs (Level 2) | Money market funds | ||
Assets at fair value on a recurring basis | ||
Cash equivalents | 0 | 0 |
Recurring Basis | Significant Unobservable Inputs (Level 3) | ||
Assets at fair value on a recurring basis | ||
Total | 5,000 | 0 |
Recurring Basis | Significant Unobservable Inputs (Level 3) | U.S. Treasury securities | ||
Assets at fair value on a recurring basis | ||
Short-term investments | 0 | 0 |
Recurring Basis | Significant Unobservable Inputs (Level 3) | Equity securities with readily determinable fair values | ||
Assets at fair value on a recurring basis | ||
Equity securities with readily determinable fair values | 0 | 0 |
Recurring Basis | Significant Unobservable Inputs (Level 3) | Convertible debt instrument | ||
Assets at fair value on a recurring basis | ||
Convertible debt instrument | 5,000 | |
Recurring Basis | Significant Unobservable Inputs (Level 3) | U.S. Treasury securities | ||
Assets at fair value on a recurring basis | ||
Cash equivalents | 0 | 0 |
Recurring Basis | Significant Unobservable Inputs (Level 3) | Money market funds | ||
Assets at fair value on a recurring basis | ||
Cash equivalents | $ 0 | $ 0 |
Collaborative and Licensing A_3
Collaborative and Licensing Arrangements - Recognized Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues | ||||
Total revenues | $ 387,628 | $ 206,440 | $ 1,035,826 | $ 962,304 |
Collaboration | ||||
Revenues | ||||
Total revenues | 38,122 | 13,979 | 120,236 | 525,102 |
License revenue | ||||
Revenues | ||||
Total revenues | 0 | 0 | 0 | 484,646 |
Research and development service revenue | ||||
Revenues | ||||
Total revenues | 9,834 | 13,979 | 34,074 | 40,456 |
Right to access intellectual property revenue | ||||
Revenues | ||||
Total revenues | 26,249 | 0 | 78,746 | 0 |
Other | ||||
Revenues | ||||
Total revenues | $ 2,039 | $ 0 | $ 7,416 | $ 0 |
Collaborative and Licensing A_4
Collaborative and Licensing Arrangements - Novartis (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Jan. 31, 2022 | Jan. 31, 2021 | |
Research and Development Arrangement, Contract to Perform for Others | ||||||
Total revenues | $ 387,628 | $ 206,440 | $ 1,035,826 | $ 962,304 | ||
Research and development service revenue | ||||||
Research and Development Arrangement, Contract to Perform for Others | ||||||
Total revenues | 9,834 | 13,979 | 34,074 | 40,456 | ||
License revenue | ||||||
Research and Development Arrangement, Contract to Perform for Others | ||||||
Remaining performance obligation | 71,980 | 71,980 | ||||
Total revenues | 0 | 0 | 0 | 484,646 | ||
Other | ||||||
Research and Development Arrangement, Contract to Perform for Others | ||||||
Remaining performance obligation | 213,450 | 213,450 | ||||
Total revenues | 2,039 | 0 | 7,416 | 0 | ||
Novartis | Research and development service revenue | ||||||
Research and Development Arrangement, Contract to Perform for Others | ||||||
Total revenues | 8,043 | $ 13,979 | 28,699 | $ 40,456 | ||
Collaborative Arrangement | Novartis | ||||||
Research and Development Arrangement, Contract to Perform for Others | ||||||
Upfront cash payment received | $ 300,000 | $ 650,000 | ||||
Maximum proceeds from milestones | 745,000 | 1,300,000 | ||||
Maximum achievement of sales milestone | $ 1,150,000 | 250,000 | ||||
Collaborative Arrangement | Novartis | Research and development service revenue | ||||||
Research and Development Arrangement, Contract to Perform for Others | ||||||
Fair value of intangible asset | 420,000 | |||||
Remaining performance obligation | 14,570 | 14,570 | 165,354 | |||
Total revenues | $ 1,791 | $ 5,375 | ||||
Collaborative Arrangement | Novartis | License revenue | ||||||
Research and Development Arrangement, Contract to Perform for Others | ||||||
Remaining performance obligation | 484,646 | |||||
Collaborative Arrangement | Novartis | Collaborative Arrangement, Transfer of Know-How | ||||||
Research and Development Arrangement, Contract to Perform for Others | ||||||
Fair value of intangible asset | $ 1,231,000 |
Collaborative and Licensing A_5
Collaborative and Licensing Arrangements - Ociperlimab Option, Collaboration and License Agreement and China Broad Market Development Agreement (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2022 USD ($) | Mar. 31, 2022 product | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Jan. 31, 2022 USD ($) | Jan. 31, 2021 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Number of products | product | 5 | ||||||
Total revenues | $ 387,628 | $ 206,440 | $ 1,035,826 | $ 962,304 | |||
License revenue | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Total revenues | 0 | 0 | 0 | 484,646 | |||
Remaining performance obligation | 71,980 | 71,980 | |||||
Other | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Total revenues | 2,039 | 0 | 7,416 | 0 | |||
Remaining performance obligation | 213,450 | 213,450 | |||||
Research and development service revenue | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Total revenues | 9,834 | 13,979 | 34,074 | 40,456 | |||
Right to access intellectual property revenue | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Total revenues | 26,249 | 0 | 78,746 | 0 | |||
United States | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Total revenues | 134,789 | 43,471 | 348,538 | 427,280 | |||
Novartis | Research and development service revenue | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Total revenues | 8,043 | $ 13,979 | 28,699 | $ 40,456 | |||
Novartis | Collaborative Arrangement | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Upfront cash payment received | $ 300,000 | $ 650,000 | |||||
Maximum proceeds from milestones | 745,000 | 1,300,000 | |||||
Maximum achievement of sales milestone | $ 1,150,000 | 250,000 | |||||
Novartis | Collaborative Arrangement | License revenue | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Remaining performance obligation | 484,646 | ||||||
Novartis | Collaborative Arrangement | Research and development service revenue | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Total revenues | 1,791 | 5,375 | |||||
Remaining performance obligation | $ 14,570 | $ 14,570 | $ 165,354 | ||||
Novartis | Collaborative Arrangement | United States | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Collaborative arrangement co detailing and co-field (percent) | 5,000% | ||||||
Novartis | Collaborative Arrangement | MEXICO | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Collaborative arrangement co detailing and co-field (percent) | 2,500% | ||||||
Novartis | Collaborative Arrangement | CANADA | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Collaborative arrangement co detailing and co-field (percent) | 2,500% | ||||||
Novartis | Collaborative Arrangement | Minimum | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Additional upfront cash payment upon the exercise of option | $ 600,000 | ||||||
Novartis | Collaborative Arrangement | Maximum | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Additional upfront cash payment upon the exercise of option | $ 700,000 |
Collaborative and Licensing A_6
Collaborative and Licensing Arrangements - Amgen (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | ||
Jan. 02, 2020 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Research and Development Arrangement, Contract to Perform for Others | ||||
Payments to acquire equity interest | $ 0 | $ 50,000 | ||
Ordinary Shares | ||||
Research and Development Arrangement, Contract to Perform for Others | ||||
Share price, ADS (in dollars per share) | $ 132.74 | |||
Proceeds from ADS shares | $ 2,109,902 | |||
Amgen, Inc | Product Revenue | Product Concentration Risk | ||||
Research and Development Arrangement, Contract to Perform for Others | ||||
Concentration risk, percentage | 100% | |||
Beigene Ltd | Amgen, Inc | ||||
Research and Development Arrangement, Contract to Perform for Others | ||||
Minority interest in investment (as a percent) | 20.50% | |||
Amgen, Inc | ||||
Research and Development Arrangement, Contract to Perform for Others | ||||
Maximum cash and service commitment | $ 1,250,000 | |||
Shares issued (in shares) | 15,895,001 | 2,151,877 | ||
Per share acquisition price (in dollars per share) | $ 174.85 | |||
Fair value of cost share liability | $ 601,857 | |||
Payments to acquire equity interest | 2,779,241 | $ 50 | ||
Fair value of equity investments issued | 2,162,407 | |||
Fair value of financing commitment | $ 616,834 | |||
Amgen, Inc | Minimum | ||||
Research and Development Arrangement, Contract to Perform for Others | ||||
Commercialization term (years) | 5 years | |||
Amgen, Inc | Maximum | ||||
Research and Development Arrangement, Contract to Perform for Others | ||||
Commercialization term (years) | 7 years |
Collaborative and Licensing A_7
Collaborative and Licensing Arrangements - Funding Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Research and Development Arrangement, Contract to Perform for Others | ||||
Research and development expense | $ 426,363 | $ 351,937 | $ 1,194,485 | $ 1,028,754 |
Amgen, Inc | ||||
Research and Development Arrangement, Contract to Perform for Others | ||||
Research and development expense | 25,462 | 29,710 | 72,251 | 85,040 |
Amortization of research and development cost share liability | 24,806 | 28,943 | 70,389 | 82,846 |
Total amount due to Amgen for BeiGene's portion of the development funding | 50,268 | $ 58,653 | 142,640 | $ 167,886 |
Remaining portion of development funding cap | $ 648,419 | $ 648,419 |
Collaborative and Licensing A_8
Collaborative and Licensing Arrangements - Financing Liability (Details) - Amgen, Inc - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Research and Development Arrangement, Contract to Perform for Others | ||
Research and development cost share liability, current portion | $ 115,721 | $ 120,801 |
Research and development cost share liability, non-current portion | 204,252 | 269,561 |
Total research and development cost share liability | $ 319,973 | $ 390,362 |
Collaborative Arrangements - Am
Collaborative Arrangements - Amounts and Classification of Payments (Income/(Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Research and Development Arrangement, Contract to Perform for Others | |||||
Total | $ (14,660) | $ (12,545) | $ (36,926) | $ (27,721) | |
Amgen, Inc | Collaborative Arrangement | |||||
Research and Development Arrangement, Contract to Perform for Others | |||||
Collaborative arrangement, inventory purchases | 29,269 | 32,129 | 59,330 | 50,983 | |
Accounts payable current | 95,087 | 95,087 | $ 106,790 | ||
Cost of sales - product | |||||
Research and Development Arrangement, Contract to Perform for Others | |||||
Total | 319 | 380 | 3,797 | 1,058 | |
Research and development | |||||
Research and Development Arrangement, Contract to Perform for Others | |||||
Total | (1,125) | (373) | (227) | (310) | |
Selling, general and administrative | |||||
Research and Development Arrangement, Contract to Perform for Others | |||||
Total | $ (13,854) | $ (12,552) | $ (40,496) | $ (28,469) |
Restricted Cash and Investmen_3
Restricted Cash and Investments - Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Investments, Debt and Equity Securities [Abstract] | ||
Restricted cash | $ 3,380 | $ 7,209 |
Restricted Cash and Investmen_4
Restricted Cash and Investments - Short-Term Investments (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Short-term investments | ||
Amortized Cost | $ 883,126,000 | $ 2,245,662,000 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 11,128,000 | 3,700,000 |
Fair Value (Net Carrying Amount) | 871,998,000 | 2,241,962,000 |
U.S. Treasury securities | ||
Short-term investments | ||
Amortized Cost | 883,126,000 | 2,245,662,000 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 11,128,000 | 3,700,000 |
Fair Value (Net Carrying Amount) | 871,998,000 | $ 2,241,962,000 |
Allowance for credit loss | $ 0 |
Restricted Cash and Investmen_5
Restricted Cash and Investments - Equity Securities with/without Readily Determinable Fair Values and Equity-Method Investments (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2021 | Jan. 31, 2020 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Schedule of Investments | |||||||
Unrealized losses (gains) on equity investments | $ (16,413) | $ 17,166 | |||||
Equity securities without readily determinable fair values | $ 56,789 | 56,789 | $ 43,722 | ||||
Gain on investment | 4,699 | 5,065 | |||||
Equity method investment | 25,787 | 25,787 | $ 22,955 | ||||
Other Income | |||||||
Schedule of Investments | |||||||
Unrealized losses (gains) on equity investments | $ 1,357 | $ (564) | $ 2,591 | (1,221) | |||
Leap Therapeutic, Inc | |||||||
Schedule of Investments | |||||||
Equity method investments (percent) | 7.40% | 7.40% | |||||
Equity method investments, including warrants (percent) | 11.70% | 11.70% | |||||
Unrealized losses (gains) on equity investments | $ (2,950) | $ 23,764 | $ (25,611) | $ 18,388 | |||
Leap Therapeutic, Inc | Series B Preferred Stock | |||||||
Schedule of Investments | |||||||
Payments to acquire equity securities | $ 5,000 | ||||||
Leap Therapeutic, Inc | Common Stock | |||||||
Schedule of Investments | |||||||
Payments to acquire equity securities | $ 7,250 |
Restricted Cash and Investmen_6
Restricted Cash and Investments - Fair value of Common Stock and Warrants (Details) - Leap Therapeutic, Inc - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Fair value of Leap common stock | ||
Schedule of Investments | ||
Equity securities with readily determinable fair values | $ 6,467 | $ 23,809 |
Fair value of Leap warrants | ||
Schedule of Investments | ||
Equity securities with readily determinable fair values | $ 2,037 | $ 10,306 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 88,953 | $ 78,140 |
Work in process | 22,737 | 9,397 |
Finished goods | 179,221 | 155,089 |
Total inventories | $ 290,911 | $ 242,626 |
Property, plant and equipment -
Property, plant and equipment - Tabular Disclosure (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Property and equipment | ||
Property, plant and equipment, at cost | $ 609,413 | $ 525,048 |
Less: accumulated depreciation | (149,692) | (124,286) |
Construction In Progress, Net | 222,193 | 186,843 |
Property, plant and equipment, net | 681,914 | 587,605 |
Land | ||
Property and equipment | ||
Property, plant and equipment, at cost | 65,485 | 65,485 |
Laboratory equipment | ||
Property and equipment | ||
Property, plant and equipment, at cost | 137,990 | 118,203 |
Leasehold improvements | ||
Property and equipment | ||
Property, plant and equipment, at cost | 50,005 | 50,288 |
Building | ||
Property and equipment | ||
Property, plant and equipment, at cost | 170,243 | 144,083 |
Manufacturing equipment | ||
Property and equipment | ||
Property, plant and equipment, at cost | 147,433 | 119,585 |
Software, electronics and office equipment | ||
Property and equipment | ||
Property, plant and equipment, at cost | $ 38,257 | $ 27,404 |
Property, plant and equipment_2
Property, plant and equipment - Narratives (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Nov. 30, 2021 USD ($) a | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | |
Property, Plant and Equipment | |||||
Depreciation and amortization expense | $ 15,214 | $ 11,773 | $ 45,255 | $ 32,440 | |
Land Located in Hopewell, NJ | |||||
Property, Plant and Equipment | |||||
Area of land | a | 42 | ||||
Payments to acquire land | $ 75,197 |
Intangible Assets - Intangible
Intangible Assets - Intangible Assets Outstanding (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Finite-lived intangible assets: | ||
Gross carrying amount | $ 48,748 | $ 51,710 |
Accumulated amortization | (7,899) | (5,031) |
Intangible assets, net | 40,849 | 46,679 |
Product distribution rights | ||
Finite-lived intangible assets: | ||
Gross carrying amount | 7,500 | 7,500 |
Accumulated amortization | (3,813) | (3,250) |
Intangible assets, net | 3,687 | 4,250 |
Developed product | ||
Finite-lived intangible assets: | ||
Gross carrying amount | 40,432 | 43,394 |
Accumulated amortization | (3,270) | (965) |
Intangible assets, net | 37,162 | 42,429 |
Trading license | ||
Finite-lived intangible assets: | ||
Gross carrying amount | 816 | 816 |
Accumulated amortization | (816) | (816) |
Intangible assets, net | $ 0 | $ 0 |
Intangible Assets - Useful Life
Intangible Assets - Useful Life (Details) | 9 Months Ended |
Sep. 30, 2022 | |
Product distribution rights | |
Other intangible assets | |
Useful life (in years) | 10 years |
Product distribution rights | Weighted Average | |
Other intangible assets | |
Useful life (in years) | 12 years |
Trading license | Weighted Average | |
Other intangible assets | |
Useful life (in years) | 12 years |
Intangible Assets - Future Amor
Intangible Assets - Future Amortization Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Finite-lived intangible assets: | ||||
Amortization of intangible assets | $ 987 | $ 404 | $ 3,007 | $ 896 |
Cost of sales - product | ||||
Finite-lived intangible assets: | ||||
Amortization of intangible assets | 800 | 216 | 2,444 | 333 |
Operating Expenses | ||||
Finite-lived intangible assets: | ||||
Amortization of intangible assets | $ 187 | $ 188 | $ 563 | $ 563 |
Intangible Assets - Expected Am
Intangible Assets - Expected Amortization Expense (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Acquired Finite-Lived Intangible Assets | ||
2022 (remainder of year) | $ 967 | |
2023 | 3,867 | |
2024 | 3,867 | |
2025 | 3,867 | |
2026 | 3,867 | |
2027 and thereafter | 24,414 | |
Intangible assets, net | 40,849 | $ 46,679 |
Cost of sales - product | ||
Acquired Finite-Lived Intangible Assets | ||
2022 (remainder of year) | 779 | |
2023 | 3,117 | |
2024 | 3,117 | |
2025 | 3,117 | |
2026 | 3,117 | |
2027 and thereafter | 23,915 | |
Intangible assets, net | 37,162 | |
Operating Expenses | ||
Acquired Finite-Lived Intangible Assets | ||
2022 (remainder of year) | 188 | |
2023 | 750 | |
2024 | 750 | |
2025 | 750 | |
2026 | 750 | |
2027 and thereafter | 499 | |
Intangible assets, net | $ 3,687 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income taxes | ||||
Income tax expense (benefit) | $ 6,318 | $ 5,036 | $ 28,408 | $ 15,354 |
Unrecognized tax benefits | 12,725 | 12,725 | ||
Increase in uncertain tax position | $ 960 | $ 2,800 |
Supplemental Balance Sheet In_3
Supplemental Balance Sheet Information - Allowance For Credit Loss (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Accounts Receivable, Allowance for Credit Loss | ||
Balance at beginning of the period | $ 415 | $ 112 |
Current period provision for expected credit losses | (161) | (7) |
Amounts written-off | 0 | 0 |
Exchange rate changes | (2) | 3 |
Balance at end of the period | $ 252 | $ 108 |
Supplemental Balance Sheet In_4
Supplemental Balance Sheet Information - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Prepaid expenses and other current assets | ||
Prepaid research and development costs | $ 74,575 | $ 87,239 |
Prepaid manufacturing cost | 60,971 | 78,538 |
Prepaid taxes | 11,494 | 58,579 |
Other receivables | 11,272 | 12,010 |
Interest receivable | 2,203 | 5,052 |
Prepaid insurance | 6,465 | 1,695 |
Short-term deposit | 10,917 | 2,982 |
Other current assets | 21,869 | 24,078 |
Total | $ 199,766 | $ 270,173 |
Supplemental Balance Sheet In_5
Supplemental Balance Sheet Information - Schedule of Other Non-current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Other non-current assets | ||
Goodwill | $ 109 | $ 109 |
Prepayment of property and equipment | 17,951 | 14,140 |
Prepayment of facility capacity expansion activities | 19,676 | 24,237 |
Prepaid VAT | 217 | 17,162 |
Rental deposits and other | 6,520 | 6,609 |
Long-term investments | 96,080 | 100,792 |
Total | $ 140,553 | $ 163,049 |
Supplemental Balance Sheet In_6
Supplemental Balance Sheet Information - Schedule of Accrued Expenses and Other Payables (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued expenses and other payables | ||
Compensation related | $ 142,837 | $ 139,966 |
External research and development activities related | 114,008 | 213,922 |
Commercial activities | 34,646 | 71,560 |
Employee tax withholdings | 25,879 | 45,661 |
Sales rebates and returns related | 49,890 | 59,639 |
Professional fees and other | 42,995 | 27,307 |
Total | $ 410,255 | $ 558,055 |
Supplemental Balance Sheet In_7
Supplemental Balance Sheet Information - Schedule of Other Long-term Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Other long-term liabilities | ||
Deferred government grant income | $ 37,700 | $ 46,352 |
Pension liability | 7,330 | 7,814 |
Other | 139 | 68 |
Total | $ 45,169 | $ 54,234 |
Debt - Short-term and Long-term
Debt - Short-term and Long-term Debt Obligations (Details) $ in Thousands | 9 Months Ended | ||||||||
Jul. 22, 2022 CNY (¥) | Jan. 22, 2020 CNY (¥) | Sep. 30, 2022 USD ($) | Sep. 30, 2022 CNY (¥) | Dec. 31, 2021 USD ($) | Dec. 31, 2021 CNY (¥) | Dec. 31, 2020 CNY (¥) | Sep. 30, 2020 USD ($) | Sep. 30, 2020 CNY (¥) | |
Debt Instrument | |||||||||
Short-term debt | $ 441,275 | ¥ 3,138,961,000 | $ 427,565 | ¥ 2,724,732,000 | |||||
Long-term bank loans | 208,058 | 1,480,000,000 | 202,113 | 1,288,000,000 | |||||
Loans Payable | |||||||||
Debt Instrument | |||||||||
Short-term debt | $ 167,868 | 1,194,115,000 | 209,048 | 1,332,197,000 | |||||
Zhuhai Hillhouse (the "Related Party Loan") | Loans Payable | |||||||||
Debt Instrument | |||||||||
Line of Credit | $ 58,912 | ¥ 400,000,000 | |||||||
Short-Term Debt April 4, 2018 | China Construction Bank | Loans Payable | |||||||||
Debt Instrument | |||||||||
Line of Credit | 580,000 | ||||||||
Term | 9 years | ||||||||
Short-term debt | $ 4,077 | 29,000,000 | 1,255 | 8,000,000 | |||||
Short-Term Debt January 22 2020 | China Merchants Bank | Loans Payable | |||||||||
Debt Instrument | |||||||||
Line of Credit | ¥ 1,100,000,000 | ¥ 350,000,000 | |||||||
Term | 9 years | 9 years | |||||||
Interest Rate | 4.40% | ||||||||
Short-term debt | $ 1,406 | 10,000,000 | 1,569 | 10,000,000 | |||||
Short-Term Debt Dated November 9 2020 | China Merchants Bank | Loans Payable | |||||||||
Debt Instrument | |||||||||
Line of Credit | 378,000,000 | ||||||||
Term | 9 years | ||||||||
Short-term debt | $ 3,866 | 27,500,000 | 0 | 0 | |||||
Short-Term Debt September 24, 2020 | China Minsheng Bank (the "Senior Loan") | Loans Payable | |||||||||
Debt Instrument | |||||||||
Line of Credit | $ | $ 200,000 | $ 200,000 | |||||||
Interest Rate | 4.50% | ||||||||
Short-term debt | $ 200,000 | 1,422,677,000 | 200,000 | 1,274,535,000 | |||||
Short-Term Debt September 24, 2020 | Zhuhai Hillhouse (the "Related Party Loan") | Loans Payable | |||||||||
Debt Instrument | |||||||||
Line of Credit | 500,000 | ||||||||
Interest Rate | 4.50% | ||||||||
Short-term debt | $ 14,058 | 100,000,000 | 15,693 | 100,000,000 | |||||
Short-Term Debt February 25 2022 | Shanghai Pudong Development Bank | Loans Payable | |||||||||
Debt Instrument | |||||||||
Line of Credit | $ | $ 50,000 | ||||||||
Term | 1 year | ||||||||
Interest Rate | 2.20% | ||||||||
Short-term debt | $ 50,000 | 355,669,000 | 0 | 0 | |||||
Long-Term Bank April 4, 2018 | China Construction Bank | Loans Payable | |||||||||
Debt Instrument | |||||||||
Line of Credit | 580,000 | ||||||||
Term | 9 years | ||||||||
Interest Rate | 4.90% | ||||||||
Long-term bank loans | $ 76,616 | 545,000,000 | 89,444 | 570,000,000 | |||||
Long-Term Bank January 22, 2020 | China Merchants Bank | Loans Payable | |||||||||
Debt Instrument | |||||||||
Term | 9 years | ||||||||
Long-term bank loans | $ 49,273 | 350,500,000 | 53,353 | 340,000,000 | |||||
Long Term Bank Loan Dated November 9 2020 | China Merchants Bank | Loans Payable | |||||||||
Debt Instrument | |||||||||
Line of Credit | 378,000 | ||||||||
Term | 9 years | ||||||||
Long-term bank loans | $ 46,743 | 332,500,000 | 59,316 | 378,000,000 | |||||
Long Term Bank Loan Dated July 29, 2022 | China CITIC Bank | Loans Payable | |||||||||
Debt Instrument | |||||||||
Line of Credit | ¥ 480,000,000 | 480,000 | |||||||
Term | 10 years | 10 years | |||||||
Long-term bank loans | $ 35,426 | ¥ 252,000,000 | $ 0 | ¥ 0 |
Debt - Narratives (Details)
Debt - Narratives (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||
Jul. 22, 2022 CNY (¥) | Sep. 30, 2020 USD ($) | Sep. 30, 2022 USD ($) option | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) option | Sep. 30, 2022 CNY (¥) | Sep. 30, 2021 USD ($) | Dec. 31, 2022 CNY (¥) | Sep. 30, 2022 CNY (¥) option | Dec. 31, 2021 CNY (¥) | Dec. 31, 2020 CNY (¥) | Sep. 30, 2020 CNY (¥) | |
Debt Instrument | ||||||||||||
Proceeds from long-term loan | $ | $ 37,372,000 | $ 16,838,000 | ||||||||||
Repayment of short-term loans | $ | 145,428,000 | 40,229,000 | ||||||||||
Interest expense | $ | $ 5,596,000 | $ 7,609,000 | 16,580,000 | 22,186,000 | ||||||||
Interest capitalized | $ | 527,000 | $ 275,000 | $ 2,462,000 | $ 526,000 | ||||||||
Zhuhai Hillhouse (the "Related Party Loan") | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Line of Credit | $ 58,912,000 | ¥ 400,000,000 | ||||||||||
China Industrial Bank | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Interest Rate | 3.10% | 3.10% | ||||||||||
Line of Credit | ¥ 2,435,000 | ¥ 2,435,000 | ||||||||||
China Industrial Bank | Loans Payable | Forecast | ||||||||||||
Debt Instrument | ||||||||||||
Line of Credit | ¥ 2,435,000 | |||||||||||
China Industrial Bank | Loans Payable | Working Capital Facility | Beijing Innerway Bio-tech Co., Ltd | ||||||||||||
Debt Instrument | ||||||||||||
Repayment of short-term loans | $ 143,688,000 | ¥ 930,082,000 | ||||||||||
Long-Term Bank April 4, 2018 | China Construction Bank | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Repayment of long-term loan | $ 1,142,000 | ¥ 7,500,000 | ||||||||||
Long-Term Bank April 4, 2018 | China Construction Bank | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Interest Rate | 4.90% | 4.90% | ||||||||||
Debt instrument term (in years) | 9 years | 9 years | ||||||||||
Line of Credit | ¥ 580,000 | |||||||||||
Repayment of long-term loan | $ 598,000 | ¥ 4,000,000 | ||||||||||
Short-Term Debt April 4, 2018 | China Construction Bank | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Debt instrument term (in years) | 9 years | 9 years | ||||||||||
Line of Credit | ¥ 580,000 | |||||||||||
Senior loan Reserved For JV Purchase | China Minsheng Bank (the "Senior Loan") | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Line of Credit | $ | 120,000,000 | |||||||||||
Working Capital | China Minsheng Bank (the "Senior Loan") | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Line of Credit | $ | $ 80,000,000 | $ 80,000,000 | ||||||||||
Senior Loan | China Minsheng Bank (the "Senior Loan") | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Extension options (option) | option | 2 | 2 | 2 | |||||||||
Extension period (month) | 12 months | 12 months | ||||||||||
Long-Term Bank January 22, 2020 | China Merchants Bank | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Debt instrument term (in years) | 9 years | 9 years | ||||||||||
Short-Term Debt September 24, 2020 | China Minsheng Bank (the "Senior Loan") | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Interest Rate | 4.50% | 4.50% | ||||||||||
Line of Credit | $ | $ 200,000,000 | $ 200,000,000 | $ 200,000,000 | |||||||||
Short-Term Debt September 24, 2020 | Zhuhai Hillhouse (the "Related Party Loan") | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Interest Rate | 4.50% | 4.50% | ||||||||||
Line of Credit | ¥ 500,000 | |||||||||||
Fully repaid business days (days) | 10 days | |||||||||||
Short-Term Debt Dated November 9 2020 | China Merchants Bank | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Debt instrument term (in years) | 9 years | 9 years | ||||||||||
Line of Credit | ¥ 378,000,000 | |||||||||||
Fixed annual interest rate (as a percent) | 4.30% | 4.30% | 4.30% | |||||||||
Junior Loan General Corporate Use | Zhuhai Hillhouse (the "Related Party Loan") | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Line of Credit | $ 14,728,000 | 100,000,000 | ||||||||||
Related Party Loan | Zhuhai Hillhouse (the "Related Party Loan") | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Line of Credit | $ 73,640,000 | ¥ 500,000,000 | ||||||||||
Long Term Bank Loan Dated November 9 2020 | China Merchants Bank | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Debt instrument term (in years) | 9 years | 9 years | ||||||||||
Line of Credit | ¥ 378,000 | |||||||||||
Proceeds from long-term loan | $ 113,774,000 | ¥ 792,000,000 | ||||||||||
Long Term Bank Loan Dated July 29, 2022 | China CITIC Bank | Loans Payable | ||||||||||||
Debt Instrument | ||||||||||||
Debt instrument term (in years) | 10 years | 10 years | 10 years | |||||||||
Line of Credit | ¥ 480,000,000 | ¥ 480,000 | ||||||||||
Fixed annual interest rate (as a percent) | 4.20% | 4.20% | 4.20% | |||||||||
Proceeds from long-term loan | $ 37,372,000 | ¥ 252,000,000 |
Product Revenue - Product Sales
Product Revenue - Product Sales (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues | ||||
Product revenue – net | $ 387,628 | $ 206,440 | $ 1,035,826 | $ 962,304 |
Product | ||||
Revenues | ||||
Product revenue – gross | 398,379 | 206,029 | 1,036,652 | 497,823 |
Less: Rebates and sales returns | (48,873) | (13,568) | (121,062) | (60,621) |
Product revenue – net | 349,506 | 192,461 | 915,590 | 437,202 |
Product | BRUKINSA® | ||||
Revenues | ||||
Product revenue – net | 155,495 | 65,832 | 388,567 | 130,345 |
Product | Tislelizumab | ||||
Revenues | ||||
Product revenue – net | 128,206 | 76,980 | 320,728 | 200,738 |
Product | REVLIMID® | ||||
Revenues | ||||
Product revenue – net | 19,046 | 20,209 | 60,622 | 46,984 |
Product | XGEVA® | ||||
Revenues | ||||
Product revenue – net | 18,148 | 15,699 | 47,156 | 33,491 |
Product | POBEVCY® | ||||
Revenues | ||||
Product revenue – net | 9,873 | 0 | 29,671 | 0 |
Product | KYPROLIS® | ||||
Revenues | ||||
Product revenue – net | 2,820 | 0 | 11,225 | 0 |
Product | BLINCYTO® | ||||
Revenues | ||||
Product revenue – net | 6,214 | 5,040 | 27,610 | 5,040 |
Product | VIDAZA® | ||||
Revenues | ||||
Product revenue – net | 3,314 | 5,810 | 12,260 | 12,771 |
Product | Pamiparib | ||||
Revenues | ||||
Product revenue – net | 1,266 | 1,516 | 5,843 | 3,737 |
Product | Other | ||||
Revenues | ||||
Product revenue – net | $ 5,124 | $ 1,375 | $ 11,908 | $ 4,096 |
Product Revenue - Accrued Sales
Product Revenue - Accrued Sales Rebates and Returns (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Accrued Sales Rebates and Returns | ||
Balance at beginning of the period | $ 59,639 | |
Balance at end of the period | 49,890 | |
Product | ||
Accrued Sales Rebates and Returns | ||
Balance at beginning of the period | 59,639 | $ 11,874 |
Accrual | 121,062 | 60,621 |
Payments | (130,811) | (52,305) |
Balance at end of the period | $ 49,890 | $ 20,190 |
Loss Per Share (Details)
Loss Per Share (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Numerator: | ||||
Net loss | $ (557,556) | $ (438,114) | $ (1,558,480) | $ (867,138) |
Denominator: | ||||
Weighted average shares outstanding—basic (in shares) | 1,345,303,747 | 1,205,971,284 | 1,337,976,853 | 1,196,391,201 |
Weighted average shares outstanding - diluted (in shares) | 1,345,303,747 | 1,205,971,284 | 1,337,976,853 | 1,196,391,201 |
Share-Based Compensation Expe_3
Share-Based Compensation Expense - Share Options and Incentive Plan (Details) - shares | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2020 | Dec. 31, 2018 | Jun. 30, 2018 | Mar. 31, 2022 | Sep. 30, 2022 | Jan. 31, 2016 | |
2016 Plan | ||||||
Share-based compensation | ||||||
Increase in ordinary shares authorized (in shares) | 57,200,000 | 38,553,159 | 66,300,000 | |||
Number of shares reserved and available for issuance (in shares) | 65,029,595 | |||||
Shares available for future grants (shares) | 74,429,673 | |||||
Percentage of shares reserved and available for issuance (as percent) | 5% | |||||
2016 Plan | Share Options | ||||||
Share-based compensation | ||||||
Granted (in shares) | 12,437,373 | |||||
Number of options outstanding (in shares) | 63,928,723 | |||||
2016 Plan | Restricted Share Units (RSUs) | ||||||
Share-based compensation | ||||||
Granted (in shares) | 37,043,877 | |||||
Number of options outstanding (in shares) | 56,502,940 | |||||
2011 Plan | ||||||
Share-based compensation | ||||||
Shares cancelled or forfeited (in shares) | 5,166,627 | |||||
2018 Plan | ||||||
Share-based compensation | ||||||
Number of shares reserved and available for issuance (in shares) | 12,000,000 | |||||
2018 Plan | Share Options | ||||||
Share-based compensation | ||||||
Number of options outstanding (in shares) | 27,846 | |||||
2018 Plan | Restricted Share Units (RSUs) | ||||||
Share-based compensation | ||||||
Number of options outstanding (in shares) | 223,028 | |||||
Employee Share Purchase Plan 2018 | ||||||
Share-based compensation | ||||||
Increase in ordinary shares authorized (in shares) | 3,855,315 | |||||
Number of shares reserved and available for issuance (in shares) | 7,355,315 | 3,500,000 | ||||
Shares available for future grants (shares) | 3,666,071 | |||||
Offering period (month) | 6 months | |||||
Discount on purchase price of common stock (as a percent) | 15% | |||||
Maximum percentage of eligible earnings as after-tax withholdings to purchase ordinary shares (as a percent) | 10% |
Share-Based Compensation Expe_4
Share-Based Compensation Expense - Shares Issued Under Employee Share Purchase Plan (Details) - Employee Share Purchase Plan 2018 - USD ($) $ / shares in Units, $ in Thousands | Aug. 31, 2022 | Feb. 28, 2022 | Aug. 31, 2021 | Feb. 26, 2021 |
Share-based Compensation Arrangement by Share-based Payment Award | ||||
Number of ordinary shares issued ( in shares) | 861,315 | 667,160 | 425,386 | 436,124 |
Market price, ADS (in dollars per share) | $ 171.66 | $ 210.52 | $ 308.30 | $ 236.30 |
Market price (in dollars per share) | 13.20 | 16.19 | 23.72 | 18.18 |
Purchase price, ADS (in dollars per share) | 145.91 | 178.94 | 262.06 | 200.86 |
Purchase price, ordinary (in dollars per share) | $ 11.22 | $ 13.76 | $ 20.16 | $ 15.45 |
Proceeds | $ 9,667 | $ 9,183 | $ 8,575 | $ 6,738 |
Share-Based Compensation Expe_5
Share-Based Compensation Expense - Expense Recognized (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based compensation | ||||
Compensation expense | $ 78,176 | $ 67,077 | $ 225,036 | $ 177,701 |
Research and development | ||||
Share-based compensation | ||||
Compensation expense | 36,417 | 31,680 | 104,382 | 83,762 |
Selling, general and administrative | ||||
Share-based compensation | ||||
Compensation expense | $ 41,759 | $ 35,397 | $ 120,654 | $ 93,939 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income (Loss) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | |
Movement in accumulated other comprehensive loss | |||||||
Balance at the beginning of period | $ 6,132,563 | $ 6,132,563 | |||||
Other comprehensive loss before reclassifications | (179,473) | ||||||
Amounts reclassified from accumulated other comprehensive income (loss) | 0 | ||||||
Net-current period other comprehensive loss | $ (79,073) | $ (99,904) | (496) | $ 485 | $ 8,891 | $ (3,738) | (179,473) |
Balance at the end of period | 4,655,171 | 4,655,171 | |||||
Accumulated Other Comprehensive Income (loss) | |||||||
Movement in accumulated other comprehensive loss | |||||||
Balance at the beginning of period | 17,950 | 17,950 | |||||
Net-current period other comprehensive loss | (79,073) | $ (99,904) | (496) | $ 485 | $ 8,891 | $ (3,738) | |
Balance at the end of period | (161,523) | (161,523) | |||||
Foreign Currency Translation Adjustments | |||||||
Movement in accumulated other comprehensive loss | |||||||
Balance at the beginning of period | 27,898 | 27,898 | |||||
Other comprehensive loss before reclassifications | (168,411) | ||||||
Amounts reclassified from accumulated other comprehensive income (loss) | 0 | ||||||
Net-current period other comprehensive loss | (168,411) | ||||||
Balance at the end of period | (140,513) | (140,513) | |||||
Unrealized Gains (Losses) on Available-for-Sale Securities | |||||||
Movement in accumulated other comprehensive loss | |||||||
Balance at the beginning of period | (3,700) | (3,700) | |||||
Other comprehensive loss before reclassifications | (11,062) | ||||||
Amounts reclassified from accumulated other comprehensive income (loss) | 0 | ||||||
Net-current period other comprehensive loss | (11,062) | ||||||
Balance at the end of period | (14,762) | (14,762) | |||||
Pension Liability Adjustments | |||||||
Movement in accumulated other comprehensive loss | |||||||
Balance at the beginning of period | $ (6,248) | (6,248) | |||||
Other comprehensive loss before reclassifications | 0 | ||||||
Amounts reclassified from accumulated other comprehensive income (loss) | 0 | ||||||
Net-current period other comprehensive loss | 0 | ||||||
Balance at the end of period | $ (6,248) | $ (6,248) |
Shareholders_ Equity (Details)
Shareholders’ Equity (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||
Jan. 02, 2020 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) shares | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2021 ¥ / shares | |
Shareholders' equity | ||||||
Proceeds from sale of ordinary shares, net of cost | $ | $ 0 | $ 50,000 | ||||
Amgen, Inc | ||||||
Shareholders' equity | ||||||
Stock issued during period, shares, new issues, american depository shares | shares | 165,529 | 165,529 | ||||
Proceeds from sale of ordinary shares, net of cost | $ | $ 2,779,241 | $ 50 | ||||
Shares issued (in shares) | shares | 15,895,001 | 2,151,877 | ||||
Per share acquisition price (in dollars per share) | $ / shares | $ 174.85 | |||||
STAR Market | IPO | ||||||
Shareholders' equity | ||||||
Proceeds from sale of ordinary shares, net of cost | $ | $ 3,392,616 | |||||
Shares issued (in shares) | shares | 115,055,260 | |||||
Per share acquisition price (in dollars per share) | (per share) | $ 391.68 | ¥ 192.60 |
Restricted Net Assets (Details)
Restricted Net Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Segment Reporting Information | ||
Minimum required statutory reserve of annual after-tax profit (as a percent) | 10% | |
Required statutory reserve as a percentage of registered capital (as a percent) | 50% | |
China | ||
Segment Reporting Information | ||
Restricted net assets | $ 2,188,139 | $ 799,574 |
Commitments and Contingencies -
Commitments and Contingencies - Commitments (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended |
Jun. 30, 2021 | Sep. 30, 2022 | |
Purchase and Capital commitments | ||
Purchase commitments | $ 142,196 | |
Minimum Purchase Commitments For Supply Purchased | ||
Purchase and Capital commitments | ||
Purchase commitments | 58,342 | |
Inventories | ||
Purchase and Capital commitments | ||
Purchase commitments | 83,854 | |
Capital Addition Purchase Commitments | ||
Purchase and Capital commitments | ||
Other commitments | 467,554 | |
Investments Funding Commitment | ||
Purchase and Capital commitments | ||
Other commitments | 16,000 | |
Maximum commitment | 19,000 | |
Pension Commitment | ||
Purchase and Capital commitments | ||
Employer contributions | 1,505 | |
Research and Development Arrangement | ||
Purchase and Capital commitments | ||
Other commitments | 23,775 | |
Commitment term (years) | 4 years | |
Amgen, Inc | ||
Purchase and Capital commitments | ||
Other commitments | 648,419 | |
Maximum cash and service commitment | $ 1,250,000 |
Segment and Geographic Inform_3
Segment and Geographic Information - Narratives (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) segment | Sep. 30, 2021 USD ($) | |
Segment information | ||||
Number of operating segments | segment | 1 | |||
Total revenues | $ 387,628 | $ 206,440 | $ 1,035,826 | $ 962,304 |
United States | ||||
Segment information | ||||
Total revenues | 134,789 | 43,471 | 348,538 | 427,280 |
Collaboration revenue | ||||
Segment information | ||||
Total revenues | 38,122 | 13,979 | 120,236 | 525,102 |
Collaboration revenue | United States | BRUKINSA® | ||||
Segment information | ||||
Total revenues | 26,685 | 9,785 | 84,165 | 367,571 |
Collaboration revenue | Rest Of World | BRUKINSA® | ||||
Segment information | ||||
Total revenues | 11,437 | 36,071 | ||
Product revenue, net | United States | BRUKINSA® | ||||
Segment information | ||||
Total revenues | 108,104 | $ 33,686 | 264,373 | $ 59,709 |
Product revenue, net | Rest Of World | BRUKINSA® | ||||
Segment information | ||||
Total revenues | $ 8,128 | $ 14,779 |
Segment and Geographic Inform_4
Segment and Geographic Information - Schedule of Revenue by Geographic Area (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Net product revenues by geographic area | ||||
Total revenues | $ 387,628 | $ 206,440 | $ 1,035,826 | $ 962,304 |
PRC | ||||
Net product revenues by geographic area | ||||
Total revenues | 233,274 | 158,775 | 636,438 | 377,392 |
United States | ||||
Net product revenues by geographic area | ||||
Total revenues | 134,789 | 43,471 | 348,538 | 427,280 |
Rest of world | ||||
Net product revenues by geographic area | ||||
Total revenues | $ 19,565 | $ 4,194 | $ 50,850 | $ 157,632 |