Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2023 | Jul. 31, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2023 | |
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 | 1,376,270,056 | |
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 | 2023 | |
Document Fiscal Period Focus | Q2 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS ¥ in Thousands, $ in Thousands | Jun. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) |
Current assets: | ||
Cash and cash equivalents | $ 3,410,368 | $ 3,869,564 |
Short-term restricted cash | 9,693 | 196 |
Short-term investments | 105,693 | 665,251 |
Accounts receivable, net | 299,282 | 173,168 |
Inventories | 321,333 | 282,346 |
Prepaid expenses and other current assets | 255,050 | 216,553 |
Total current assets | 4,401,419 | 5,207,078 |
Long-term restricted cash | 1,513 | 5,277 |
Property, plant and equipment, net | 1,031,938 | 845,946 |
Operating lease right-of-use assets | 99,422 | 109,960 |
Intangible assets, net | 46,895 | 40,616 |
Other non-current assets | 147,549 | 170,413 |
Total non-current assets | 1,327,317 | 1,172,212 |
Total assets | 5,728,736 | 6,379,290 |
Current liabilities: | ||
Accounts payable | 266,975 | 294,781 |
Accrued expenses and other payables | 454,950 | 467,352 |
Deferred revenue, current portion | 159,034 | 213,861 |
Tax payable | 17,074 | 25,189 |
Operating lease liabilities, current portion | 23,508 | 24,041 |
Research and development cost share liability, current portion | 62,516 | 114,335 |
Short-term debt | 421,052 | 328,969 |
Total current liabilities | 1,405,109 | 1,468,528 |
Non-current liabilities: | ||
Long-term bank loans | 207,426 | 209,148 |
Deferred revenue, non-current portion | 24,276 | 42,026 |
Operating lease liabilities, non-current portion | 25,821 | 34,517 |
Deferred tax liabilities | 15,652 | 15,996 |
Research and development cost share liability, non-current portion | 208,775 | 179,625 |
Other long-term liabilities | 43,118 | 46,095 |
Total non-current liabilities | 525,068 | 527,407 |
Total liabilities | 1,930,177 | 1,995,935 |
Commitments and contingencies | ||
Equity: | ||
Ordinary shares, US$0.0001 par value per share; 9,500,000,000 shares authorized; 1,376,251,336 and 1,356,140,180 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | 137 | 135 |
Additional paid-in capital | 11,752,019 | 11,540,979 |
Accumulated other comprehensive loss | (143,687) | (77,417) |
Accumulated deficit | (7,809,910) | (7,080,342) |
Total equity | 3,798,559 | 4,383,355 |
Total liabilities and equity | $ 5,728,736 | $ 6,379,290 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
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) | 1,376,251,336 | 1,356,140,180 |
Ordinary shares, shares outstanding (in shares) | 1,376,251,336 | 1,356,140,180 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenues | ||||
Total revenues | $ 595,261 | $ 341,572 | $ 1,043,062 | $ 648,198 |
Expenses | ||||
Cost of sales - product | 95,990 | 71,173 | 177,779 | 136,410 |
Research and development | 422,764 | 378,207 | 831,348 | 768,122 |
Selling, general and administrative | 395,034 | 331,403 | 723,533 | 625,976 |
Amortization of intangible assets | 188 | 188 | 375 | 376 |
Total expenses | 913,976 | 780,971 | 1,733,035 | 1,530,884 |
Loss from operations | (318,715) | (439,399) | (689,973) | (882,686) |
Interest income, net | 15,070 | 11,431 | 31,086 | 21,502 |
Other expense, net | (63,818) | (129,617) | (45,515) | (117,650) |
Loss before income taxes | (367,463) | (557,585) | (704,402) | (978,834) |
Income tax expense | 13,674 | 8,141 | 25,166 | 22,090 |
Net loss | $ (381,137) | $ (565,726) | $ (729,568) | $ (1,000,924) |
Net loss per share, basic (in dollars per share) | $ (0.28) | $ (0.42) | $ (0.54) | $ (0.75) |
Net loss per share, diluted (in dollars per share) | $ (0.28) | $ (0.42) | $ (0.54) | $ (0.75) |
Weighted-average shares outstanding—basic (in shares) | 1,360,224,377 | 1,336,463,026 | 1,357,211,308 | 1,334,252,648 |
Weighted-average shares outstanding - diluted (in shares) | 1,360,224,377 | 1,336,463,026 | 1,357,211,308 | 1,334,252,648 |
Net loss per American Depositary Share ("ADS") basic (in dollars per share) | $ (3.64) | $ (5.50) | $ (6.99) | $ (9.75) |
Net loss per American Depositary Share ("ADS") diluted (in dollars per share) | $ (3.64) | $ (5.50) | $ (6.99) | $ (9.75) |
Weighted-average ADSs outstanding - basic (in shares) | 104,632,644 | 102,804,848 | 104,400,870 | 102,634,819 |
Weighted-average ADSs outstanding - diluted (in shares) | 104,632,644 | 102,804,848 | 104,400,870 | 102,634,819 |
Product revenue, net | ||||
Revenues | ||||
Total revenues | $ 553,745 | $ 304,511 | $ 964,036 | $ 566,084 |
Collaboration revenue | ||||
Revenues | ||||
Total revenues | $ 41,516 | $ 37,061 | $ 79,026 | $ 82,114 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||
Net loss | $ (381,137) | $ (565,726) | $ (729,568) | $ (1,000,924) |
Other comprehensive income (loss), net of tax of nil: | ||||
Foreign currency translation adjustments | (86,519) | (97,459) | (73,172) | (88,085) |
Unrealized holding income (loss), net | 1,846 | (2,445) | 6,902 | (12,315) |
Comprehensive loss | $ (465,810) | $ (665,630) | $ (795,838) | $ (1,101,324) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Operating activities: | ||
Net loss | $ (729,568) | $ (1,000,924) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 42,346 | 32,061 |
Share-based compensation expenses | 178,693 | 146,860 |
Unrealized losses on equity investments | 2,178 | 23,529 |
Amortization of research and development cost share liability | (22,669) | (45,583) |
Deferred income tax (expense) benefits | (15) | 555 |
Other items, net | 767 | 6,360 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (131,923) | 307,430 |
Inventories | (53,598) | (31,633) |
Other assets | (30,627) | 32,335 |
Accounts payable | (32,678) | (30,362) |
Accrued expenses and other payables | (8,082) | 21,168 |
Deferred revenue | (72,577) | (76,737) |
Other liabilities | 88 | (1,581) |
Net cash used in operating activities | (857,665) | (616,522) |
Investing activities: | ||
Purchases of property, plant and equipment | (247,055) | (95,421) |
Purchase of intangible asset | 0 | 0 |
Purchases of investments | (11,582) | (11,504) |
Proceeds from sale or maturity of investments | 567,500 | 1,051,028 |
Purchase of in-process research and development | 0 | (75,000) |
Net cash provided by investing activities | 308,863 | 869,103 |
Financing activities: | ||
Proceeds from long-term loan | 15,771 | 0 |
Repayment of long-term loan | 0 | 0 |
Proceeds from short-term loans | 161,846 | 67,586 |
Repayment of short-term loans | (66,574) | (115,405) |
Proceeds from option exercises and employee share purchase plan | 35,169 | 18,972 |
Net cash provided by (used in) financing activities | 146,212 | (28,847) |
Effect of foreign exchange rate changes, net | (50,873) | (71,212) |
Net decrease in cash, cash equivalents, and restricted cash | (453,463) | 152,522 |
Cash, cash equivalents, and restricted cash at beginning of period | 3,875,037 | 4,382,887 |
Cash, cash equivalents, and restricted cash at end of period | 3,421,574 | 4,535,409 |
Supplemental cash flow information: | ||
Cash and cash equivalents | 3,410,368 | 4,531,137 |
Short-term restricted cash | 9,693 | 333 |
Long-term restricted cash | 1,513 | 3,939 |
Income taxes paid | 32,529 | 24,436 |
Interest paid | 10,015 | 12,899 |
Supplemental non-cash information: | ||
Capital expenditures included in accounts payable and accrued expenses | $ 95,404 | $ 58,676 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY - USD ($) $ in Thousands | Total | Ordinary Shares | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Balance at the beginning of period (in shares) at Dec. 31, 2021 | 1,334,804,281 | ||||
Balance at the beginning of period at Dec. 31, 2021 | $ 6,132,563 | $ 133 | $ 11,191,007 | $ 17,950 | $ (5,076,527) |
Increase (Decrease) in Stockholders' Equity | |||||
Use of shares reserved for share option exercises (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) | |||
Cost from issuance of ordinary shares | (152) | (152) | |||
Net loss | (435,198) | (435,198) | |||
Balance at the end of period (in shares) at Mar. 31, 2022 | 1,334,805,269 | ||||
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 beginning of period (in shares) at Dec. 31, 2021 | 1,334,804,281 | ||||
Balance at the beginning of period at Dec. 31, 2021 | 6,132,563 | $ 133 | 11,191,007 | 17,950 | (5,076,527) |
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (1,000,924) | ||||
Balance at the end of period (in shares) at Jun. 30, 2022 | 1,349,639,424 | ||||
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 beginning of period (in shares) at Mar. 31, 2022 | 1,334,805,269 | ||||
Balance at the beginning of period at Mar. 31, 2022 | 5,774,152 | $ 133 | 11,268,290 | 17,454 | (5,511,725) |
Increase (Decrease) in Stockholders' Equity | |||||
Use of shares reserved for share option exercises (in shares) | 5,016,232 | ||||
Exercise of options, ESPP and release of RSUs | 7,092 | $ 1 | 7,091 | ||
Exercise of options, ESPP and release of RSUs (in shares) | 9,817,923 | ||||
Share-based compensation | 81,305 | 81,305 | |||
Other comprehensive income (loss) | (99,904) | (99,904) | |||
Net loss | (565,726) | (565,726) | |||
Balance at the end of period (in shares) at Jun. 30, 2022 | 1,349,639,424 | ||||
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 beginning of period (in shares) at Dec. 31, 2022 | 1,356,140,180 | 1,356,140,180 | |||
Balance at the beginning of period at Dec. 31, 2022 | $ 4,383,355 | $ 135 | 11,540,979 | (77,417) | (7,080,342) |
Increase (Decrease) in Stockholders' Equity | |||||
Use of shares reserved for share option exercises (in shares) | (98,774) | ||||
Exercise of options, ESPP and release of RSUs | 28,657 | $ 1 | 28,656 | ||
Exercise of options, ESPP and release of RSUs (in shares) | 6,610,695 | ||||
Share-based compensation | 75,322 | 75,322 | |||
Other comprehensive income (loss) | 18,403 | 18,403 | |||
Net loss | (348,431) | (348,431) | |||
Balance at the end of period (in shares) at Mar. 31, 2023 | 1,362,652,101 | ||||
Balance at the end of period at Mar. 31, 2023 | $ 4,157,306 | $ 136 | 11,644,957 | (59,014) | (7,428,773) |
Balance at the beginning of period (in shares) at Dec. 31, 2022 | 1,356,140,180 | 1,356,140,180 | |||
Balance at the beginning of period at Dec. 31, 2022 | $ 4,383,355 | $ 135 | 11,540,979 | (77,417) | (7,080,342) |
Increase (Decrease) in Stockholders' Equity | |||||
Other comprehensive income (loss) | (66,270) | ||||
Net loss | $ (729,568) | ||||
Balance at the end of period (in shares) at Jun. 30, 2023 | 1,376,251,336 | 1,376,251,336 | |||
Balance at the end of period at Jun. 30, 2023 | $ 3,798,559 | $ 137 | 11,752,019 | (143,687) | (7,809,910) |
Balance at the beginning of period (in shares) at Mar. 31, 2023 | 1,362,652,101 | ||||
Balance at the beginning of period at Mar. 31, 2023 | 4,157,306 | $ 136 | 11,644,957 | (59,014) | (7,428,773) |
Increase (Decrease) in Stockholders' Equity | |||||
Use of shares reserved for share option exercises (in shares) | 220,116 | ||||
Exercise of options, ESPP and release of RSUs | 3,692 | $ 1 | 3,691 | ||
Exercise of options, ESPP and release of RSUs (in shares) | 13,379,119 | ||||
Share-based compensation | 103,371 | 103,371 | |||
Other comprehensive income (loss) | (84,673) | (84,673) | |||
Net loss | $ (381,137) | (381,137) | |||
Balance at the end of period (in shares) at Jun. 30, 2023 | 1,376,251,336 | 1,376,251,336 | |||
Balance at the end of period at Jun. 30, 2023 | $ 3,798,559 | $ 137 | $ 11,752,019 | $ (143,687) | $ (7,809,910) |
Description of Business, Basis
Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
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 that is discovering and developing innovative oncology treatments that are more accessible and affordable to cancer patients worldwide. The Company currently has three approved medicines that were internally discovered and developed, including BRUKINSA ® , a small molecule inhibitor of Bruton’s Tyrosine Kinase 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, the United Kingdom, Canada, Australia and additional international markets, and tislelizumab and pamiparib in China. By leveraging its strong commercial capabilities, the Company has in-licensed the rights to distribute an additional 14 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. The Company has conducted more than 120 clinical trials in-house, with over 21,000 subjects enrolled in approximately 45 regions. This includes more than 35 pivotal or potentially registration-enabling trials across its portfolio, including three internally discovered, approved medicines. The Company has built, and is expanding, its internal manufacturing capabilities. The Company is building a commercial-stage biologics manufacturing and clinical R&D center in New Jersey, in addition to its state-of-the-art biologic and small molecule manufacturing facilities in China to support current and potential future demand of its medicines. The Company also works with high quality global 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 10,000 employees worldwide, including the United States, China, Europe and Australia. Basis of presentation and consolidation The accompanying condensed consolidated balance sheet as of June 30, 2023, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2023 and 2022, the condensed consolidated statements of cash flows for the six months ended June 30, 2023 and 2022, and the condensed consolidated statements of shareholders' equity for the three and six months ended June 30, 2023 and 2022, 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, 2022 (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 six months ended June 30, 2023 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 three and six months ended June 30, 2022 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 March 2023, the FASB issued ASU 2023-01, Leases (Topic 842): Common Control Arrangements . This update requires leasehold improvements associated with common control leases be amortized by the lessee over the useful life of the leasehold improvements to the common control group (regardless of the lease term) as long as the lessee controls the use of the underlying asset (the leased asset) through a lease. However, if the lessor obtained the right to control the use of the underlying asset through a lease with another entity not within the same common control group, the amortization period may not exceed the amortization period of the common control group. Further, leasehold improvements associated with common control leases be accounted for as a transfer between entities under common control through an adjustment to equity if, and when, the lessee no longer controls the use of the underlying asset. Those leasehold improvements are subject to the impairment guidance in Topic 360, Property, Plant, and Equipment . This update is effective for annual periods beginning after December 15, 2023, and early application is permitted. This guidance should be applied either (i) prospectively to all new leasehold improvements recognized on or after the date of initial application; (ii) prospectively to all new and existing leasehold improvements recognized on or after the date of initial application, with any remaining unamortized balance of existing leasehold improvements amortized over their remaining useful life to the common control group determined at that date; or (iii) retrospectively to the beginning of the period in which the entity first applied Topic 842, with any leasehold improvements that otherwise would not have been amortized or impaired recognized through a cumulative-effect adjustment to the opening balance of retained earnings at the beginning of the earliest period presented in accordance with Topic 842. 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, 2022. There have been no material changes to the Company’s significant accounting policies as of and for the six months ended June 30, 2023, as compared to the significant accounting policies described in the Annual Report. |
Revision of Prior Period Financ
Revision of Prior Period Financial Statements | 6 Months Ended |
Jun. 30, 2023 | |
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 its previously filed financial statements for the three and six months ended June 30, 2022 (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 Statements of Operations (unaudited) Three Months Ended Six Months Ended June 30, 2022 June 30, 2022 As Reported Adjustments As Revised As Reported Adjustments As Revised $ $ $ $ $ $ Income tax expense 13,864 (5,723) 8,141 26,889 (4,799) 22,090 Net loss (571,449) 5,723 (565,726) (1,005,723) 4,799 (1,000,924) Net loss per share (0.43) 0.01 (0.42) (0.75) — (0.75) Net loss per American Depositary Share (“ADS”) (5.56) 0.06 (5.50) (9.80) 0.05 (9.75) Condensed Consolidated Statements of Comprehensive Loss (unaudited) Three Months Ended Six Months Ended June 30, 2022 June 30, 2022 As Reported Adjustments As Revised As Reported Adjustments As Revised $ $ $ $ $ $ Net loss (571,449) 5,723 (565,726) (1,005,723) 4,799 (1,000,924) Comprehensive loss (671,353) 5,723 (665,630) (1,106,123) 4,799 (1,101,324) Condensed Consolidated Statement of Cash Flows (unaudited) Six Months Ended June 30, 2022 As Reported Adjustments As Revised $ $ $ Operating activities: Net loss (1,005,723) 4,799 (1,000,924) Adjustments to reconcile net loss to net cash used in operating activities: Deferred income tax benefits 7,550 (6,995) 555 Changes in operating assets and liabilities: Other assets 32,315 20 32,335 Accrued expenses and other payables 19,525 1,643 21,168 Other liabilities (2,114) 533 (1,581) Net cash used in operating activities (616,522) — (616,522) 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 |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
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 June 30, 2023 and December 31, 2022: Quoted Price in Active Market for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs As of June 30, 2023 (Level 1) (Level 2) (Level 3) $ $ $ Cash equivalents Money market funds 847,781 — — Short-term investments (Note 5): U.S. Treasury securities 105,693 — — Prepaid expenses and other current assets (Note 5): Convertible debt instrument — — 5,190 Other non-current assets (Note 5): Equity securities with readily determinable fair values 2,300 1,077 — Convertible debt instrument — — 3,000 Total 955,774 1,077 8,190 Quoted Price in Active Market for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs As of December 31, 2022 (Level 1) (Level 2) (Level 3) $ $ $ Cash equivalents Money market funds 758,114 — — Short-term investments (Note 5): U.S. Treasury securities 665,251 — — Prepaid expenses and other current assets (Note 5): Convertible debt instrument — — 5,190 Other non-current assets (Note 5): Equity securities with readily determinable fair values 3,307 706 — Convertible debt instrument — — 3,000 Total 1,426,672 706 8,190 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 convertible notes issued by two private biotech companies. The Company has elected the fair value option method of accounting for the convertible notes. Accordingly, the convertible notes are remeasured at fair value on a recurring basis using Level 3 inputs, with any changes in the fair value option recorded in other income, net. As of June 30, 2023 and December 31, 2022, 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 | 6 Months Ended |
Jun. 30, 2023 | |
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 six months ended June 30, 2023 and 2022, the Company’s collaboration revenue primarily consisted of 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 six months ended June 30, 2023 and 2022: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Revenue from Collaborators $ $ $ $ Research and development service revenue 13,563 10,813 20,380 24,240 Right to access intellectual property revenue 26,248 26,248 52,497 52,497 Other 1,705 — 6,149 5,377 Total 41,516 37,061 79,026 82,114 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 six months ended June 30, 2021. As such, the Company recognized the entire amount of the transaction price allocated to the license as collaboration revenue during the six months ended June 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 $11,770 and $16,796 during the three and six months ended June 30, 2023, respectively, and $9,021 and $20,656 during the three and six months ended June 30, 2022, respectively. The Company also recognized other collaboration revenue of $1,344 and $5,013 during the three and six months ended June 30, 2023, respectively, and nil and $5,377 during the three and six ended June 30, 2022, respectively, related to the sale of tislelizumab clinical supply to Novartis in conjunction with the collaboration. 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 would have received an additional payment of $600,000 or $700,000 in the event Novartis exercised 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 $26,248 and $52,497 related to Novartis right to access ociperlimab in clinical trials and the transfer of know how performance obligation during the three and six months ended June 30, 2023, respectively, and $26,248 and $52,497 during the three and six months ended June 30, 2022, respectively. The Company recognized R&D service revenue of $1,792 and $3,583 during the three and six months ended June 30, 2023 and $1,792 and $3,584 during the three and six months ended June 30, 2022, respectively. The Company also recognized other collaboration revenue of $1,861 and $2,636 related primarily to revenue generated under the broad markets marketing and promotion agreement in conjunction with the collaboration during the three and six months ended June 30, 2023, respectively. In July 2023, the Company entered into a Mutual Termination and Release Agreement (the "Termination Agreement") to mutually terminate the ociperlimab option, collaboration and license agreement with Novartis, effective immediately. Pursuant to the Termination Agreement, the Company regained full, global rights to develop, manufacture and commercialize ociperlimab. 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 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). 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 Company’s ongoing assessment of the Amgen Collaboration Agreement cost-share contributions, the Company determined that further investment in the development of LUMAKRAS was no longer commercially viable for BeiGene. As a result, in February 2023, the Company and Amgen entered into the Second Amendment to the Amgen Collaboration Agreement to (i) stop sharing costs with Amgen for the further development of LUMAKRAS during the period starting January 1, 2023 and ending August 31, 2023; and (ii) cooperate in good faith to prepare a transition plan with the anticipated termination of LUMAKRAS from the Amgen Collaboration Agreement. 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. 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. Amgen relinquished its right to appoint a designated director to the Company's board of directors in January 2023. 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 six months ended June 30, 2023 and 2022 were as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ Research and development expense 5,457 24,393 23,274 46,789 Amortization of research and development cost share liability 5,271 23,764 22,669 45,583 Total amount due to Amgen for BeiGene's portion of the development funding 10,728 48,157 45,943 92,372 As of June 30, 2023 Remaining portion of development funding cap 549,765 As of June 30, 2023 and December 31, 2022, the research and development cost share liability recorded in the Company's balance sheet was as follows: As of June 30, December 31, 2023 2022 $ $ Research and development cost share liability, current portion 62,516 114,335 Research and development cost share liability, non-current portion 208,775 179,625 Total research and development cost share liability 271,291 293,960 The total reimbursement due to (from) Amgen under the commercial profit-sharing agreement for product sales is classified in the income statement for the three and six months ended June 30, 2023 and 2022 as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ Cost of sales - product 4,011 2,449 1,184 3,478 Research and development (1,769) 657 1,311 898 Selling, general and administrative (17,552) (13,661) (29,388) (26,642) Total (15,310) (10,555) (26,893) (22,266) The Company purchases commercial inventory from Amgen to distribute in China. Inventory purchases amounted to $20,146 and $39,277 during the three and six months ended June 30, 2023, respectively, and $22,462 and $30,061 during the three and six months ended June 30, 2022, respectively. Net amounts receivable from Amgen as of June 30, 2023 was $11,069 and net amounts payable to Amgen as of December 31, 2022 was $54,064, respectively. |
Restricted Cash and Investments
Restricted Cash and Investments | 6 Months Ended |
Jun. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Restricted Cash and Investments | Restricted Cash and Investments Restricted Cash The Company’s restricted cash balance of $11,206 and $5,473 as of June 30, 2023 and December 31, 2022, 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 June 30, 2023 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 107,802 — 2,109 105,693 Total 107,802 — 2,109 105,693 Short-term investments as of December 31, 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 674,262 — 9,011 665,251 Total 674,262 — 9,011 665,251 As of June 30, 2023, 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 June 30, 2023. 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 June 30, 2023, the Company's ownership interest in the outstanding common stock of Leap was 6.2% 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 9.8% 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, net. The Company recorded an unrealized gain of $470 and unrealized loss of $636 for the three and six months ended June 30, 2023, respectively, and unrealized losses of $5,908 and $22,661 for the three and six months ended June 30, 2022, respectively, in the consolidated statements of operations. As of June 30, 2023 and December 31, 2022, the fair value of the common stock and warrants were as follows: As of June 30, December 31, 2023 2022 $ $ Fair value of Leap common stock 2,300 3,307 Fair value of Leap warrants 1,077 706 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 $59,209 and $57,054 in equity securities without readily determinable fair values as of June 30, 2023 and December 31, 2022, respectively. The Company recorded no gain during the three months ended and a gain of $1,081 for the six months ended June 30, 2023, respectively, and a gain of $366 for the three and six months ended June 30, 2022, respectively, related to observable price changes in orderly transactions for similar investments of the same issuer to other income, net in the consolidated statements of operations. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories The Company’s inventory balance consisted of the following: As of June 30, December 31, 2023 2022 $ $ Raw materials 109,048 88,957 Work in process 31,472 20,886 Finished goods 180,813 172,503 Total inventories 321,333 282,346 |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment, Net | Property, Plant and Equipment, Net Property, plant and equipment, net are recorded at cost and consisted of the following: As of June 30, December 31, 2023 2022 $ $ Land 65,485 65,485 Building 214,080 222,448 Manufacturing equipment 172,844 175,679 Laboratory equipment 170,424 158,908 Leasehold improvement 53,366 53,786 Software, electronics and office equipment 72,839 47,483 Property, plant and equipment, at cost 749,038 723,789 Less: accumulated depreciation (201,406) (171,470) Construction in progress 484,306 293,627 Property, plant and equipment, net 1,031,938 845,946 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. As of June 30, 2023, the Company has construction in process of $314,707 related to the Hopewell facility construction. Depreciation expense was $21,307 and $40,332 for the three and six months ended June 30, 2023, respectively, and $14,461 and $30,041 for the three and six months ended June 30, 2022, respectively. |
Intangible Assets
Intangible Assets | 6 Months Ended |
Jun. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible Assets Intangible assets as of June 30, 2023 and December 31, 2022 are summarized as follows: As of June 30, 2023 December 31, 2022 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 (4,375) 3,125 7,500 (4,000) 3,500 Developed products 49,388 (5,618) 43,770 41,235 (4,119) 37,116 Trading license 816 (816) — 816 (816) — Total finite-lived intangible assets 57,704 (10,809) 46,895 49,551 (8,935) 40,616 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 products 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 Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ Amortization expense - Cost of sales - product 840 812 1,639 1,644 Amortization expense - Operating expense 188 188 375 376 Total 1,028 1,000 2,014 2,020 Estimated amortization expense for each of the five succeeding years and thereafter, as of June 30, 2023 is as follows: Year Ending December 31, Cost of Sales - Product Operating Expenses Total $ $ $ 2023 (remainder of year) 1,857 375 2,232 2024 3,714 750 4,464 2025 3,714 750 4,464 2026 3,714 750 4,464 2027 3,714 500 4,214 2028 and thereafter 27,057 — 27,057 Total 43,770 3,125 46,895 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesIncome tax expense was $13,674 and $25,166 for the three and six months ended June 30, 2023, respectively. Income tax expense was $8,141 and $22,090 for the three and six months ended June 30, 2022. The income tax expense for the three and six months ended June 30, 2023 and 2022 was primarily attributable to current China tax expense due to certain non-deductible expenses and current U.S. tax expense determined after other special tax deductions and research and development tax credits. 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 June 30, 2023, the Company will maintain a full valuation allowance against its net deferred tax assets. As of June 30, 2023, the Company had gross unrecognized tax benefits of $12,524. 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 $559 and $969 in the three and six months ended June 30, 2023 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 June 30, 2023 and December 31, 2022, 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 June 30, 2023, Australia tax matters are open to examination for the years 2013 through 2023, China tax matters are open to examination for the years 2013 through 2023, Switzerland tax matters are open to examination for the years 2018 through 2023, and U.S. federal tax matters are open to examination for years 2015 through 2023. Various U.S. states and other non-US tax jurisdictions in which the Company files tax returns remain open to examination for 2012 through 2023. |
Supplemental Balance Sheet Info
Supplemental Balance Sheet Information | 6 Months Ended |
Jun. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Supplemental Balance Sheet Information | Supplemental Balance Sheet Information Prepaid expenses and other current assets consist of the following: As of June 30, December 31, 2023 2022 $ $ Prepaid research and development costs 72,391 71,488 Prepaid manufacturing cost 69,319 58,950 Prepaid taxes 18,485 20,478 Other receivables 36,866 22,777 Interest receivable 1,992 3,039 Prepaid insurance 7,593 3,664 Short-term deposit for sales rebates 7,198 1,510 Other current assets 41,206 34,647 Total 255,050 216,553 Other non-current assets consist of the following: As of June 30, December 31, 2023 2022 $ $ Goodwill 109 109 Prepayment of property and equipment 13,140 22,025 Prepaid supply cost (1) 30,539 48,642 Prepaid VAT 1,734 804 Rental deposits and other 6,420 7,054 Long-term investments 95,607 91,779 Total 147,549 170,413 (1) Represents payments for future supply purchases under the license agreement with Luye Pharma Group and facility expansion 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 June 30, December 31, 2023 2022 $ $ Compensation related 135,719 184,775 External research and development activities related 91,108 139,168 Commercial activities 65,506 51,806 Individual income tax and other taxes 38,486 18,815 Sales rebates and returns related 85,591 41,817 Other 38,540 30,971 Total 454,950 467,352 Other long-term liabilities consist of the following: As of June 30, December 31, 2023 2022 $ $ Deferred government grant income 34,865 38,176 Pension liability 7,996 7,760 Other 257 159 Total 43,118 46,095 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Debt | Debt The following table summarizes the Company's short-term and long-term debt obligations as of June 30, 2023 and December 31, 2022: Lender Agreement Date Line of Credit Term Maturity Date Interest Rate As of June 30, 2023 December 31, 2022 $ RMB $ RMB China Construction Bank April 4, 2018 RMB580,000 9-year April 4, 2027 (1) 10,343 75,000 7,250 50,000 China Merchants Bank January 22, 2020 (2) 9-year January 20, 2029 (2) 5,024 36,429 1,450 10,000 China Merchants Bank November 9, 2020 RMB378,000 9-year November 8, 2029 (3) 5,516 40,000 5,437 37,500 China Minsheng Bank (the “Senior Loan”) September 24, 2020 $200,000 (4) 4.3% 150,000 1,087,666 150,000 1,034,554 Shanghai Pudong Development Bank February 25, 2022 $50,000 1-year February 25, 2023 2.2% — — 50,000 344,851 China Merchants Bank June 5, 2023 RMB 400,000 1-year June 4, 2024 3.2% 55,164 400,000 — — HSBC Bank May 4, 2023 RMB 340,000 1-year May 3, 2024 4.7% 46,889 340,000 — — China Industrial Bank May 30, 2023 RMB 200,000 1-year May 29, 2024 2.8% 27,582 200,000 — — Other short-term debt (5) 120,534 874,000 114,832 792,000 Total short-term debt 421,052 3,053,095 328,969 2,268,905 China Construction Bank April 4, 2018 RMB580,000 9-year April 4, 2027 (1) 64,818 470,000 75,395 520,000 China Merchants Bank January 22, 2020 (2) 9-year January 20, 2029 (2) 41,176 298,571 47,847 330,000 China Merchants Bank November 9, 2020 RMB378,000 9-year November 8, 2029 (3) 44,200 320,500 49,369 340,500 China CITIC Bank July 29, 2022 RMB480,000 10-year July 28, 2032 (6) 57,232 415,000 36,537 252,000 Total long-term bank loans 207,426 1,504,071 209,148 1,442,500 1. The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC. The loan interest rate was 4.5% as of June 30, 2023. 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 $3,483 (RMB25,000) during the six months ended June 30, 2023. 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 4.1% as of June 30, 2023. The Company repaid $731 (RMB5,000) during the six months ended June 30, 2023. 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 4.0% as of June 30, 2023. The loan is secured by fixed assets placed into service upon completion of the third phase of the Guangzhou manufacturing facility's build out. The Company repaid $2,518 (RMB17,500) during the six months ended June 30, 2023. 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. On September 30, 2022, the Company entered into an amendment and restatement agreement with China Minsheng Bank to extend the maturity date to October 9, 2023. 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. During the years ended December 31, 2022 and 2021, the Company entered into short-term working capital loans with China Industrial Bank and China Merchants Bank to borrow up to RMB875,000 in aggregate, with maturity dates ranging from December 15, 2022 to September 18, 2023. The Company repaid $16,574 (RMB117,000) and drew down $28,174 (RMB199,000) during the six months ended June 30, 2023.The weighted average interest rate for the short-term working capital loans was approximately 2.6% as of June 30, 2023. 6. 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 Company drew down $22,502 (RMB163,000) during the six months ended June 30, 2023. The weighted average loan interest rate was 4.1% as of June 30, 2023. The loan is secured by BeiGene Suzhou Co., Ltd.'s land use right. Interest Expense |
Product Revenue
Product Revenue | 6 Months Ended |
Jun. 30, 2023 | |
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 China, and other regions, and tislelizumab and pamiparib in China; XGEVA, BLINCYTO and KYPROLIS in China under a license from Amgen; REVLIMID ® and VIDAZA ® in China under a license from BMS; and POBEVCY ® in China under a license from Bio-Thera. The table below presents the Company’s net product sales for the three and six months ended June 30, 2023 and 2022. Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ Product revenue – gross 667,328 342,885 1,176,933 638,273 Less: Rebates and sales returns (113,583) (38,374) (212,897) (72,189) Product revenue – net 553,745 304,511 964,036 566,084 The following table disaggregates net product sales by product for the three and six months ended June 30, 2023 and 2022: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ BRUKINSA ® 308,276 128,747 519,658 233,072 Tislelizumab 149,464 104,879 264,314 192,522 REVLIMID ® 21,847 19,916 45,005 41,576 XGEVA ® 23,968 15,509 44,165 29,008 POBEVCY ® 13,438 12,983 27,764 19,798 BLINCYTO ® 14,578 9,530 25,524 21,396 KYPROLIS ® 11,052 4,092 15,995 8,405 VIDAZA ® 3,930 3,434 7,119 8,946 Pamiparib 1,919 2,022 3,725 4,577 Other 5,273 3,399 10,767 6,784 Total product revenue – net 553,745 304,511 964,036 566,084 The following table presents the roll-forward of accrued sales rebates and returns for the six months ended June 30, 2023 and 2022: Six Months Ended June 30, 2023 2022 $ $ Balance at beginning of the period 41,817 59,639 Accrual 212,897 72,189 Payments (169,123) (60,316) Balance at end of the period 85,591 71,512 |
Loss Per Share
Loss Per Share | 6 Months Ended |
Jun. 30, 2023 | |
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 Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ Numerator: Net loss (381,137) (565,726) (729,568) (1,000,924) Denominator: Weighted average shares outstanding—basic and diluted 1,360,224,377 1,336,463,026 1,357,211,308 1,334,252,648 For the three and six months ended June 30, 2023 and 2022, 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 | 6 Months Ended |
Jun. 30, 2023 | |
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 June 30, 2023, ordinary shares cancelled or forfeited under the 2011 Plan that were carried over to the 2016 Plan totaled 5,166,822. 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 six months ended June 30, 2023, the Company granted options for 9,396,660 ordinary shares and restricted share units for 29,453,021 ordinary shares under the 2016 Plan. As of June 30, 2023, options and restricted share units for ordinary shares outstanding under the 2016 Plan totaled 64,070,175 and 68,073,668, respectively. As of June 30, 2023, share-based awards to acquire 38,873,106 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”). As of June 30, 2023, there were no options or restricted share units for ordinary shares outstanding under the 2018 Plan. 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 June 30, 2023, 2,735,219 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 February 28, 2023 930,582 $ 171.10 $ 13.16 $ 145.44 $ 11.19 $ 10,414 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 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 six months ended June 30, 2023 and 2022: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ Research and development 45,948 37,107 79,976 52,082 Selling, general and administrative 57,381 44,198 98,741 58,542 Total 103,329 81,305 178,717 110,624 |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Loss | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Accumulated Other Comprehensive Loss | Accumulated Other Comprehensive Loss The movement of accumulated other comprehensive 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, 2022 (62,523) (9,011) (5,883) (77,417) Other comprehensive (loss) income before reclassifications (73,172) 6,902 — (66,270) Net-current period other comprehensive (loss) income (73,172) 6,902 — (66,270) Balance as of June 30, 2023 (135,695) (2,109) (5,883) (143,687) |
Shareholders_ Equity
Shareholders’ Equity | 6 Months Ended |
Jun. 30, 2023 | |
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, September 24, 2020 and January 30, 2023 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 | 6 Months Ended |
Jun. 30, 2023 | |
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 June 30, 2023 and December 31, 2022, the net assets of the Company’s PRC subsidiaries amounted to $3,305,583 and $3,548,881, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Purchase Commitments As of June 30, 2023, the Company had purchase commitments amounting to $104,115, of which $40,295 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $63,820 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 $381,187 for the acquisition of property, plant and equipment as of June 30, 2023, 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 June 30, 2023, the Company's remaining co-development funding commitment was $549,765. 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 June 30, 2023, the total research and development commitment amounted to $17,990. Funding Commitment The Company had committed capital related to two equity method investments in the amount of $15,057. As of June 30, 2023, the remaining capital commitment was $10,557 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 $2,627 per year based on annual funding contributions in effect as of June 30, 2023 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 with contract research organizations (“CROs”) to some extent 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 generally become due and payable upon achievement of such milestones or sales. These commitments are not recorded on the Company's balance sheet because the achievement and timing of these milestones are not fixed and determinable. When the achievement of these milestones or sales have occurred, the corresponding amounts are recognized in the Company’s financial statements. Legal Proceedings |
Segment and Geographic Informat
Segment and Geographic Information | 6 Months Ended |
Jun. 30, 2023 | |
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 product revenues by geographic area are presented as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ PRC 293,919 212,429 540,828 403,164 United States 223,540 88,381 362,307 156,269 Rest of world 36,286 3,701 60,901 6,651 Total 553,745 304,511 964,036 566,084 Total collaboration revenues by geographic area are presented as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ PRC 1,861 — 2,636 — United States 28,809 25,943 54,523 57,480 Rest of world 10,846 11,118 21,867 24,634 Total 41,516 37,061 79,026 82,114 |
Subsequent Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent EventsOn July 28, 2023 (the “Signing Date”), a credit facility agreement (the “Credit Agreement”) was entered into by and between the Company, as the borrower, and China Merchants Bank Co., Ltd., as the lender (the “Lender”). The Credit Agreement provides for a $400 million uncommitted and unsecured credit facility (the “Credit Facility”), pursuant to which each loan issued has a term up to one year, provided that all loans must be repaid within eighteen months of the Signing Date. Loans under the Credit Facility have a floating interest rate based on the secured overnight financing rate plus an applicable margin and are calculated daily from the date the loan is utilized and settled on a quarterly basis. The proceeds of the loans under the Credit Facility are available to finance the working capital needs and for daily operations of the Company and its subsidiaries. The Credit Agreement contains financial covenants that require the Company to uphold certain ratios of liabilities to ownership equity, maintain specified amounts of both consolidated net assets and consolidated cash balance, and reach a certain amount of annual sales revenue for products, all which are tested either quarterly or annually. The Credit Agreement also contains operating covenants including, among other things, (i) maintaining its listing status on The Stock Exchange of Hong Kong Limited and The Science and Technology Innovation Board of the Shanghai Stock Exchange, (ii) preserving interest reserve in the account with the Lender, (iii) limitations on the incurrence of certain additional indebtedness, and (iv) preservation of ownership of key patents and other covenants surrounding the Company’s intellectual property. Other certain covenants, representations and warranties, and events of default, are contained in the Credit Agreement, many of which would be breached or triggered solely to the extent they have a material adverse effect on the Company’s ability to perform its obligations under the Credit Agreement or affect the Company’s normal operations. As of the date of this report, no borrowings were outstanding under the Credit Agreement. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Pay vs Performance Disclosure | ||||||
Net loss | $ (381,137) | $ (348,431) | $ (565,726) | $ (435,198) | $ (729,568) | $ (1,000,924) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended | 6 Months Ended |
Jun. 30, 2023 shares | Jun. 30, 2023 shares | |
Trading Arrangements, by Individual | ||
Material Terms of Trading Arrangement | Chan Lee, the Company’s Senior Vice President and General Counsel, entered into a 10b5-1 trading plan on May 9, 2023. Mr. Lee’s plan provides for sales of both options and restricted stock units commencing on the later of: (i) August 8, 2023 or (ii) the earlier of (a) the third business day following the disclosure of the Company’s financial results in a Form 10-Q for the completed fiscal quarter in which the plan is adopted; or (b) September 7, 2023, with such sales ending on August 14, 2024. The maximum number of options to be sold under the plan is 7,257 American Depositary Shares ("ADSs"). The maximum number of shares to be sold under the plan is 1,440 ADSs. Mr. Lee’s trading plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act and the Company’s insider trading policy. | |
Rule 10b5-1 Arrangement Adopted | true | |
Non-Rule 10b5-1 Arrangement Adopted | false | |
Rule 10b5-1 Arrangement Terminated | false | |
Non-Rule 10b5-1 Arrangement Terminated | false | |
Chan Lee [Member] | ||
Trading Arrangements, by Individual | ||
Name | Chan Lee | |
Title | Senior Vice President | |
Adoption Date | May 9, 2023 | |
Arrangement Duration | 463 days | |
Chan Lee Trading Arrangement, Options [Member] | Chan Lee [Member] | ||
Trading Arrangements, by Individual | ||
Aggregate Available | 7,257 | 7,257 |
Description of Business, Basi_2
Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
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 June 30, 2023, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2023 and 2022, the condensed consolidated statements of cash flows for the six months ended June 30, 2023 and 2022, and the condensed consolidated statements of shareholders' equity for the three and six months ended June 30, 2023 and 2022, 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, 2022 (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 six months ended June 30, 2023 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 | Use of estimatesThe 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 three and six months ended June 30, 2022 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 March 2023, the FASB issued ASU 2023-01, Leases (Topic 842): Common Control Arrangements . This update requires leasehold improvements associated with common control leases be amortized by the lessee over the useful life of the leasehold improvements to the common control group (regardless of the lease term) as long as the lessee controls the use of the underlying asset (the leased asset) through a lease. However, if the lessor obtained the right to control the use of the underlying asset through a lease with another entity not within the same common control group, the amortization period may not exceed the amortization period of the common control group. Further, leasehold improvements associated with common control leases be accounted for as a transfer between entities under common control through an adjustment to equity if, and when, the lessee no longer controls the use of the underlying asset. Those leasehold improvements are subject to the impairment guidance in Topic 360, Property, Plant, and Equipment . This update is effective for annual periods beginning after December 15, 2023, and early application is permitted. This guidance should be applied either (i) prospectively to all new leasehold improvements recognized on or after the date of initial application; (ii) prospectively to all new and existing leasehold improvements recognized on or after the date of initial application, with any remaining unamortized balance of existing leasehold improvements amortized over their remaining useful life to the common control group determined at that date; or (iii) retrospectively to the beginning of the period in which the entity first applied Topic 842, with any leasehold improvements that otherwise would not have been amortized or impaired recognized through a cumulative-effect adjustment to the opening balance of retained earnings at the beginning of the earliest period presented in accordance with Topic 842. 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, 2022. |
Revision of Prior Period Fina_2
Revision of Prior Period Financial Statements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Changes and Error Corrections [Abstract] | |
Schedule of Effect of Correcting these Accounting Errors | 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 Statements of Operations (unaudited) Three Months Ended Six Months Ended June 30, 2022 June 30, 2022 As Reported Adjustments As Revised As Reported Adjustments As Revised $ $ $ $ $ $ Income tax expense 13,864 (5,723) 8,141 26,889 (4,799) 22,090 Net loss (571,449) 5,723 (565,726) (1,005,723) 4,799 (1,000,924) Net loss per share (0.43) 0.01 (0.42) (0.75) — (0.75) Net loss per American Depositary Share (“ADS”) (5.56) 0.06 (5.50) (9.80) 0.05 (9.75) Condensed Consolidated Statements of Comprehensive Loss (unaudited) Three Months Ended Six Months Ended June 30, 2022 June 30, 2022 As Reported Adjustments As Revised As Reported Adjustments As Revised $ $ $ $ $ $ Net loss (571,449) 5,723 (565,726) (1,005,723) 4,799 (1,000,924) Comprehensive loss (671,353) 5,723 (665,630) (1,106,123) 4,799 (1,101,324) Condensed Consolidated Statement of Cash Flows (unaudited) Six Months Ended June 30, 2022 As Reported Adjustments As Revised $ $ $ Operating activities: Net loss (1,005,723) 4,799 (1,000,924) Adjustments to reconcile net loss to net cash used in operating activities: Deferred income tax benefits 7,550 (6,995) 555 Changes in operating assets and liabilities: Other assets 32,315 20 32,335 Accrued expenses and other payables 19,525 1,643 21,168 Other liabilities (2,114) 533 (1,581) Net cash used in operating activities (616,522) — (616,522) 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 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule 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 June 30, 2023 and December 31, 2022: Quoted Price in Active Market for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs As of June 30, 2023 (Level 1) (Level 2) (Level 3) $ $ $ Cash equivalents Money market funds 847,781 — — Short-term investments (Note 5): U.S. Treasury securities 105,693 — — Prepaid expenses and other current assets (Note 5): Convertible debt instrument — — 5,190 Other non-current assets (Note 5): Equity securities with readily determinable fair values 2,300 1,077 — Convertible debt instrument — — 3,000 Total 955,774 1,077 8,190 Quoted Price in Active Market for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs As of December 31, 2022 (Level 1) (Level 2) (Level 3) $ $ $ Cash equivalents Money market funds 758,114 — — Short-term investments (Note 5): U.S. Treasury securities 665,251 — — Prepaid expenses and other current assets (Note 5): Convertible debt instrument — — 5,190 Other non-current assets (Note 5): Equity securities with readily determinable fair values 3,307 706 — Convertible debt instrument — — 3,000 Total 1,426,672 706 8,190 |
Collaborative and Licensing A_2
Collaborative and Licensing Arrangements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Research and Development [Abstract] | |
Schedule of Net Product Sales | The following table summarizes total collaboration revenue recognized for the three and six months ended June 30, 2023 and 2022: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Revenue from Collaborators $ $ $ $ Research and development service revenue 13,563 10,813 20,380 24,240 Right to access intellectual property revenue 26,248 26,248 52,497 52,497 Other 1,705 — 6,149 5,377 Total 41,516 37,061 79,026 82,114 The table below presents the Company’s net product sales for the three and six months ended June 30, 2023 and 2022. Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ Product revenue – gross 667,328 342,885 1,176,933 638,273 Less: Rebates and sales returns (113,583) (38,374) (212,897) (72,189) Product revenue – net 553,745 304,511 964,036 566,084 The following table disaggregates net product sales by product for the three and six months ended June 30, 2023 and 2022: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ BRUKINSA ® 308,276 128,747 519,658 233,072 Tislelizumab 149,464 104,879 264,314 192,522 REVLIMID ® 21,847 19,916 45,005 41,576 XGEVA ® 23,968 15,509 44,165 29,008 POBEVCY ® 13,438 12,983 27,764 19,798 BLINCYTO ® 14,578 9,530 25,524 21,396 KYPROLIS ® 11,052 4,092 15,995 8,405 VIDAZA ® 3,930 3,434 7,119 8,946 Pamiparib 1,919 2,022 3,725 4,577 Other 5,273 3,399 10,767 6,784 Total product revenue – net 553,745 304,511 964,036 566,084 |
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 six months ended June 30, 2023 and 2022 were as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ Research and development expense 5,457 24,393 23,274 46,789 Amortization of research and development cost share liability 5,271 23,764 22,669 45,583 Total amount due to Amgen for BeiGene's portion of the development funding 10,728 48,157 45,943 92,372 As of June 30, 2023 Remaining portion of development funding cap 549,765 As of June 30, 2023 and December 31, 2022, the research and development cost share liability recorded in the Company's balance sheet was as follows: As of June 30, December 31, 2023 2022 $ $ Research and development cost share liability, current portion 62,516 114,335 Research and development cost share liability, non-current portion 208,775 179,625 Total research and development cost share liability 271,291 293,960 |
Schedule of Amounts and Classification of Reimbursement Expense | The total reimbursement due to (from) Amgen under the commercial profit-sharing agreement for product sales is classified in the income statement for the three and six months ended June 30, 2023 and 2022 as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ Cost of sales - product 4,011 2,449 1,184 3,478 Research and development (1,769) 657 1,311 898 Selling, general and administrative (17,552) (13,661) (29,388) (26,642) Total (15,310) (10,555) (26,893) (22,266) |
Restricted Cash and Investmen_2
Restricted Cash and Investments (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Short-Term Investments | Short-term investments as of June 30, 2023 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 107,802 — 2,109 105,693 Total 107,802 — 2,109 105,693 Short-term investments as of December 31, 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 674,262 — 9,011 665,251 Total 674,262 — 9,011 665,251 |
Schedule of Fair Value of the Common Stock and Warrants | As of June 30, 2023 and December 31, 2022, the fair value of the common stock and warrants were as follows: As of June 30, December 31, 2023 2022 $ $ Fair value of Leap common stock 2,300 3,307 Fair value of Leap warrants 1,077 706 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | The Company’s inventory balance consisted of the following: As of June 30, December 31, 2023 2022 $ $ Raw materials 109,048 88,957 Work in process 31,472 20,886 Finished goods 180,813 172,503 Total inventories 321,333 282,346 |
Property, Plant and Equipment_2
Property, Plant and Equipment, Net (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment, Net | Property, plant and equipment, net are recorded at cost and consisted of the following: As of June 30, December 31, 2023 2022 $ $ Land 65,485 65,485 Building 214,080 222,448 Manufacturing equipment 172,844 175,679 Laboratory equipment 170,424 158,908 Leasehold improvement 53,366 53,786 Software, electronics and office equipment 72,839 47,483 Property, plant and equipment, at cost 749,038 723,789 Less: accumulated depreciation (201,406) (171,470) Construction in progress 484,306 293,627 Property, plant and equipment, net 1,031,938 845,946 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets Outstanding and Amortization Expense | Intangible assets as of June 30, 2023 and December 31, 2022 are summarized as follows: As of June 30, 2023 December 31, 2022 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 (4,375) 3,125 7,500 (4,000) 3,500 Developed products 49,388 (5,618) 43,770 41,235 (4,119) 37,116 Trading license 816 (816) — 816 (816) — Total finite-lived intangible assets 57,704 (10,809) 46,895 49,551 (8,935) 40,616 Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ Amortization expense - Cost of sales - product 840 812 1,639 1,644 Amortization expense - Operating expense 188 188 375 376 Total 1,028 1,000 2,014 2,020 |
Schedule of Finite-Lived Intangible Assets Amortization Expense | Estimated amortization expense for each of the five succeeding years and thereafter, as of June 30, 2023 is as follows: Year Ending December 31, Cost of Sales - Product Operating Expenses Total $ $ $ 2023 (remainder of year) 1,857 375 2,232 2024 3,714 750 4,464 2025 3,714 750 4,464 2026 3,714 750 4,464 2027 3,714 500 4,214 2028 and thereafter 27,057 — 27,057 Total 43,770 3,125 46,895 |
Supplemental Balance Sheet In_2
Supplemental Balance Sheet Information (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following: As of June 30, December 31, 2023 2022 $ $ Prepaid research and development costs 72,391 71,488 Prepaid manufacturing cost 69,319 58,950 Prepaid taxes 18,485 20,478 Other receivables 36,866 22,777 Interest receivable 1,992 3,039 Prepaid insurance 7,593 3,664 Short-term deposit for sales rebates 7,198 1,510 Other current assets 41,206 34,647 Total 255,050 216,553 |
Schedule of Other Non-Current Assets | Other non-current assets consist of the following: As of June 30, December 31, 2023 2022 $ $ Goodwill 109 109 Prepayment of property and equipment 13,140 22,025 Prepaid supply cost (1) 30,539 48,642 Prepaid VAT 1,734 804 Rental deposits and other 6,420 7,054 Long-term investments 95,607 91,779 Total 147,549 170,413 (1) Represents payments for future supply purchases under the license agreement with Luye Pharma Group and facility expansion 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 June 30, December 31, 2023 2022 $ $ Compensation related 135,719 184,775 External research and development activities related 91,108 139,168 Commercial activities 65,506 51,806 Individual income tax and other taxes 38,486 18,815 Sales rebates and returns related 85,591 41,817 Other 38,540 30,971 Total 454,950 467,352 |
Schedule of Other Long-Term Liabilities | Other long-term liabilities consist of the following: As of June 30, December 31, 2023 2022 $ $ Deferred government grant income 34,865 38,176 Pension liability 7,996 7,760 Other 257 159 Total 43,118 46,095 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Short-Term and Long-Term Debt Obligations | The following table summarizes the Company's short-term and long-term debt obligations as of June 30, 2023 and December 31, 2022: Lender Agreement Date Line of Credit Term Maturity Date Interest Rate As of June 30, 2023 December 31, 2022 $ RMB $ RMB China Construction Bank April 4, 2018 RMB580,000 9-year April 4, 2027 (1) 10,343 75,000 7,250 50,000 China Merchants Bank January 22, 2020 (2) 9-year January 20, 2029 (2) 5,024 36,429 1,450 10,000 China Merchants Bank November 9, 2020 RMB378,000 9-year November 8, 2029 (3) 5,516 40,000 5,437 37,500 China Minsheng Bank (the “Senior Loan”) September 24, 2020 $200,000 (4) 4.3% 150,000 1,087,666 150,000 1,034,554 Shanghai Pudong Development Bank February 25, 2022 $50,000 1-year February 25, 2023 2.2% — — 50,000 344,851 China Merchants Bank June 5, 2023 RMB 400,000 1-year June 4, 2024 3.2% 55,164 400,000 — — HSBC Bank May 4, 2023 RMB 340,000 1-year May 3, 2024 4.7% 46,889 340,000 — — China Industrial Bank May 30, 2023 RMB 200,000 1-year May 29, 2024 2.8% 27,582 200,000 — — Other short-term debt (5) 120,534 874,000 114,832 792,000 Total short-term debt 421,052 3,053,095 328,969 2,268,905 China Construction Bank April 4, 2018 RMB580,000 9-year April 4, 2027 (1) 64,818 470,000 75,395 520,000 China Merchants Bank January 22, 2020 (2) 9-year January 20, 2029 (2) 41,176 298,571 47,847 330,000 China Merchants Bank November 9, 2020 RMB378,000 9-year November 8, 2029 (3) 44,200 320,500 49,369 340,500 China CITIC Bank July 29, 2022 RMB480,000 10-year July 28, 2032 (6) 57,232 415,000 36,537 252,000 Total long-term bank loans 207,426 1,504,071 209,148 1,442,500 1. The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC. The loan interest rate was 4.5% as of June 30, 2023. 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 $3,483 (RMB25,000) during the six months ended June 30, 2023. 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 4.1% as of June 30, 2023. The Company repaid $731 (RMB5,000) during the six months ended June 30, 2023. 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 4.0% as of June 30, 2023. The loan is secured by fixed assets placed into service upon completion of the third phase of the Guangzhou manufacturing facility's build out. The Company repaid $2,518 (RMB17,500) during the six months ended June 30, 2023. 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. On September 30, 2022, the Company entered into an amendment and restatement agreement with China Minsheng Bank to extend the maturity date to October 9, 2023. 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. During the years ended December 31, 2022 and 2021, the Company entered into short-term working capital loans with China Industrial Bank and China Merchants Bank to borrow up to RMB875,000 in aggregate, with maturity dates ranging from December 15, 2022 to September 18, 2023. The Company repaid $16,574 (RMB117,000) and drew down $28,174 (RMB199,000) during the six months ended June 30, 2023.The weighted average interest rate for the short-term working capital loans was approximately 2.6% as of June 30, 2023. 6. 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 Company drew down $22,502 (RMB163,000) during the six months ended June 30, 2023. The weighted average loan interest rate was 4.1% as of June 30, 2023. The loan is secured by BeiGene Suzhou Co., Ltd.'s land use right. |
Product Revenue (Tables)
Product Revenue (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Net Product Sales | The following table summarizes total collaboration revenue recognized for the three and six months ended June 30, 2023 and 2022: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Revenue from Collaborators $ $ $ $ Research and development service revenue 13,563 10,813 20,380 24,240 Right to access intellectual property revenue 26,248 26,248 52,497 52,497 Other 1,705 — 6,149 5,377 Total 41,516 37,061 79,026 82,114 The table below presents the Company’s net product sales for the three and six months ended June 30, 2023 and 2022. Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ Product revenue – gross 667,328 342,885 1,176,933 638,273 Less: Rebates and sales returns (113,583) (38,374) (212,897) (72,189) Product revenue – net 553,745 304,511 964,036 566,084 The following table disaggregates net product sales by product for the three and six months ended June 30, 2023 and 2022: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ BRUKINSA ® 308,276 128,747 519,658 233,072 Tislelizumab 149,464 104,879 264,314 192,522 REVLIMID ® 21,847 19,916 45,005 41,576 XGEVA ® 23,968 15,509 44,165 29,008 POBEVCY ® 13,438 12,983 27,764 19,798 BLINCYTO ® 14,578 9,530 25,524 21,396 KYPROLIS ® 11,052 4,092 15,995 8,405 VIDAZA ® 3,930 3,434 7,119 8,946 Pamiparib 1,919 2,022 3,725 4,577 Other 5,273 3,399 10,767 6,784 Total product revenue – net 553,745 304,511 964,036 566,084 |
Schedule of Accrued Sales Rebates and Returns | The following table presents the roll-forward of accrued sales rebates and returns for the six months ended June 30, 2023 and 2022: Six Months Ended June 30, 2023 2022 $ $ Balance at beginning of the period 41,817 59,639 Accrual 212,897 72,189 Payments (169,123) (60,316) Balance at end of the period 85,591 71,512 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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 Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ Numerator: Net loss (381,137) (565,726) (729,568) (1,000,924) Denominator: Weighted average shares outstanding—basic and diluted 1,360,224,377 1,336,463,026 1,357,211,308 1,334,252,648 |
Share-Based Compensation Expe_2
Share-Based Compensation Expense (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule 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 February 28, 2023 930,582 $ 171.10 $ 13.16 $ 145.44 $ 11.19 $ 10,414 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 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. |
Schedule of Total Compensation Cost Recognized | The following table summarizes total share-based compensation expense recognized for the three and six months ended June 30, 2023 and 2022: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ Research and development 45,948 37,107 79,976 52,082 Selling, general and administrative 57,381 44,198 98,741 58,542 Total 103,329 81,305 178,717 110,624 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Loss (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Schedule of Accumulated Other Comprehensive Loss | The movement of accumulated other comprehensive 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, 2022 (62,523) (9,011) (5,883) (77,417) Other comprehensive (loss) income before reclassifications (73,172) 6,902 — (66,270) Net-current period other comprehensive (loss) income (73,172) 6,902 — (66,270) Balance as of June 30, 2023 (135,695) (2,109) (5,883) (143,687) |
Segment and Geographic Inform_2
Segment and Geographic Information (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Segment Reporting [Abstract] | |
Schedule of Net Product Revenues by Geographic Area | Total product revenues by geographic area are presented as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ PRC 293,919 212,429 540,828 403,164 United States 223,540 88,381 362,307 156,269 Rest of world 36,286 3,701 60,901 6,651 Total 553,745 304,511 964,036 566,084 Total collaboration revenues by geographic area are presented as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 $ $ $ $ PRC 1,861 — 2,636 — United States 28,809 25,943 54,523 57,480 Rest of world 10,846 11,118 21,867 24,634 Total 41,516 37,061 79,026 82,114 |
Description of Business, Basi_3
Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies (Details) employee in Thousands | Jun. 30, 2023 employee medicine region trial product patient |
Organization | |
Number of approved medicines | medicine | 3 |
Clinical trials conducted | trial | 120 |
Number of patients (over) | patient | 21,000 |
Number of regions | region | 45 |
Product candidate | product | 3 |
Number of employees | employee | 10 |
Minimum | |
Organization | |
Products on trial (more than) | trial | 35 |
Product distribution rights | |
Organization | |
Approved medicines | medicine | 14 |
Revision of Prior Period Fina_3
Revision of Prior Period Financial Statements - Condensed Consolidated Statements of Operations (unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
New Accounting Pronouncements or Change in Accounting Principle | ||||||
Income tax expense | $ 13,674 | $ 8,141 | $ 25,166 | $ 22,090 | ||
Net loss | $ (381,137) | $ (348,431) | $ (565,726) | $ (435,198) | $ (729,568) | $ (1,000,924) |
Net loss per share, basic (in dollars per share) | $ (0.28) | $ (0.42) | $ (0.54) | $ (0.75) | ||
Net loss per share, diluted (in dollars per share) | (0.28) | (0.42) | (0.54) | (0.75) | ||
Net loss per American Depositary Share ("ADS") basic (in dollars per share) | (3.64) | (5.50) | (6.99) | (9.75) | ||
Net loss per American Depositary Share ("ADS") diluted (in dollars per share) | $ (3.64) | $ (5.50) | $ (6.99) | $ (9.75) | ||
As Reported | ||||||
New Accounting Pronouncements or Change in Accounting Principle | ||||||
Income tax expense | $ 13,864 | $ 26,889 | ||||
Net loss | $ (571,449) | (434,274) | $ (1,005,723) | |||
Net loss per share, basic (in dollars per share) | $ (0.43) | $ (0.75) | ||||
Net loss per share, diluted (in dollars per share) | (0.43) | (0.75) | ||||
Net loss per American Depositary Share ("ADS") basic (in dollars per share) | (5.56) | (9.80) | ||||
Net loss per American Depositary Share ("ADS") diluted (in dollars per share) | $ (5.56) | $ (9.80) | ||||
Adjustments | ||||||
New Accounting Pronouncements or Change in Accounting Principle | ||||||
Income tax expense | $ (5,723) | $ (4,799) | ||||
Net loss | $ 5,723 | $ (924) | $ 4,799 | |||
Net loss per share, basic (in dollars per share) | $ 0.01 | $ 0 | ||||
Net loss per share, diluted (in dollars per share) | 0.01 | 0 | ||||
Net loss per American Depositary Share ("ADS") basic (in dollars per share) | 0.06 | 0.05 | ||||
Net loss per American Depositary Share ("ADS") diluted (in dollars per share) | $ 0.06 | $ 0.05 |
Revision of Prior Period Fina_4
Revision of Prior Period Financial Statements - Condensed Consolidated Statements of Comprehensive Loss (unaudited) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
New Accounting Pronouncements or Change in Accounting Principle | ||||||
Net loss | $ (381,137) | $ (348,431) | $ (565,726) | $ (435,198) | $ (729,568) | $ (1,000,924) |
Comprehensive loss | $ (465,810) | (665,630) | $ (795,838) | (1,101,324) | ||
As Reported | ||||||
New Accounting Pronouncements or Change in Accounting Principle | ||||||
Net loss | (571,449) | (434,274) | (1,005,723) | |||
Comprehensive loss | (671,353) | (1,106,123) | ||||
Adjustments | ||||||
New Accounting Pronouncements or Change in Accounting Principle | ||||||
Net loss | 5,723 | $ (924) | 4,799 | |||
Comprehensive loss | $ 5,723 | $ 4,799 |
Revision of Prior Period Fina_5
Revision of Prior Period Financial Statements - Condensed Consolidated Statement of Cash Flows (unaudited) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Operating activities: | ||||||
Net loss | $ (381,137) | $ (348,431) | $ (565,726) | $ (435,198) | $ (729,568) | $ (1,000,924) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
Deferred income tax benefits | (15) | 555 | ||||
Changes in operating assets and liabilities: | ||||||
Other assets | (30,627) | 32,335 | ||||
Accrued expenses and other payables | (8,082) | 21,168 | ||||
Other liabilities | 88 | (1,581) | ||||
Net cash used in operating activities | $ (857,665) | (616,522) | ||||
As Reported | ||||||
Operating activities: | ||||||
Net loss | (571,449) | (434,274) | (1,005,723) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
Deferred income tax benefits | 7,550 | |||||
Changes in operating assets and liabilities: | ||||||
Other assets | 32,315 | |||||
Accrued expenses and other payables | 19,525 | |||||
Other liabilities | (2,114) | |||||
Net cash used in operating activities | (616,522) | |||||
Adjustments | ||||||
Operating activities: | ||||||
Net loss | $ 5,723 | $ (924) | 4,799 | |||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
Deferred income tax benefits | (6,995) | |||||
Changes in operating assets and liabilities: | ||||||
Other assets | 20 | |||||
Accrued expenses and other payables | 1,643 | |||||
Other liabilities | 533 | |||||
Net cash used in operating activities | $ 0 |
Revision of Prior Period Fina_6
Revision of Prior Period Financial Statements - Condensed Consolidated Statement of Stockholders' Equity (unaudited) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Increase (Decrease) in Stockholders' Equity | ||||||
Balance at the beginning of period | $ 4,157,306 | $ 4,383,355 | $ 5,774,152 | $ 6,132,563 | $ 4,383,355 | $ 6,132,563 |
Net loss | (381,137) | (348,431) | (565,726) | (435,198) | (729,568) | (1,000,924) |
Balance at the end of period | 3,798,559 | 4,157,306 | 5,196,919 | 5,774,152 | 3,798,559 | 5,196,919 |
Accumulated Deficit | ||||||
Increase (Decrease) in Stockholders' Equity | ||||||
Balance at the beginning of period | (7,428,773) | (7,080,342) | (5,511,725) | (5,076,527) | (7,080,342) | (5,076,527) |
Net loss | (381,137) | (348,431) | (565,726) | (435,198) | ||
Balance at the end of period | $ (7,809,910) | $ (7,428,773) | (6,077,451) | (5,511,725) | $ (7,809,910) | (6,077,451) |
As Reported | ||||||
Increase (Decrease) in Stockholders' Equity | ||||||
Balance at the beginning of period | 5,885,500 | 6,242,987 | 6,242,987 | |||
Net loss | (571,449) | (434,274) | (1,005,723) | |||
Balance at the end of period | 5,302,544 | 5,885,500 | 5,302,544 | |||
As Reported | Accumulated Deficit | ||||||
Increase (Decrease) in Stockholders' Equity | ||||||
Balance at the beginning of period | (5,400,377) | (4,966,103) | (4,966,103) | |||
Net loss | (571,449) | (434,274) | ||||
Balance at the end of period | (5,971,826) | (5,400,377) | (5,971,826) | |||
Adjustments | ||||||
Increase (Decrease) in Stockholders' Equity | ||||||
Balance at the beginning of period | (111,348) | (110,424) | (110,424) | |||
Net loss | 5,723 | (924) | 4,799 | |||
Balance at the end of period | (105,625) | (111,348) | (105,625) | |||
Adjustments | Accumulated Deficit | ||||||
Increase (Decrease) in Stockholders' Equity | ||||||
Balance at the beginning of period | (111,348) | (110,424) | (110,424) | |||
Net loss | 5,723 | (924) | ||||
Balance at the end of period | $ (105,625) | $ (111,348) | $ (105,625) |
Fair Value Measurements (Detail
Fair Value Measurements (Details) $ in Thousands | Jun. 30, 2023 USD ($) company | Dec. 31, 2022 USD ($) |
Assets at fair value on a recurring basis | ||
Short-term investments | $ 105,693 | $ 665,251 |
Other non-current assets (Note 5): | ||
Number of companies in which notes are held | company | 2 | |
U.S. Treasury securities | ||
Assets at fair value on a recurring basis | ||
Short-term investments | $ 105,693 | 665,251 |
Recurring Basis | Quoted Price in Active Market for Identical Assets (Level 1) | ||
Other non-current assets (Note 5): | ||
Total | 955,774 | 1,426,672 |
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 | 105,693 | 665,251 |
Recurring Basis | Quoted Price in Active Market for Identical Assets (Level 1) | Convertible debt instrument | ||
Prepaid expenses and other current assets (Note 5): | ||
Convertible debt instrument | 0 | 0 |
Other non-current assets (Note 5): | ||
Convertible debt instrument | 0 | 0 |
Recurring Basis | Quoted Price in Active Market for Identical Assets (Level 1) | Equity securities with readily determinable fair values | ||
Other non-current assets (Note 5): | ||
Equity securities with readily determinable fair values | 2,300 | 3,307 |
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 | 847,781 | 758,114 |
Recurring Basis | Significant Other Observable Inputs (Level 2) | ||
Other non-current assets (Note 5): | ||
Total | 1,077 | 706 |
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) | Convertible debt instrument | ||
Prepaid expenses and other current assets (Note 5): | ||
Convertible debt instrument | 0 | 0 |
Other non-current assets (Note 5): | ||
Convertible debt instrument | 0 | 0 |
Recurring Basis | Significant Other Observable Inputs (Level 2) | Equity securities with readily determinable fair values | ||
Other non-current assets (Note 5): | ||
Equity securities with readily determinable fair values | 1,077 | 706 |
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) | ||
Other non-current assets (Note 5): | ||
Total | 8,190 | 8,190 |
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) | Convertible debt instrument | ||
Prepaid expenses and other current assets (Note 5): | ||
Convertible debt instrument | 5,190 | 5,190 |
Other non-current assets (Note 5): | ||
Convertible debt instrument | 3,000 | 3,000 |
Recurring Basis | Significant Unobservable Inputs (Level 3) | Equity securities with readily determinable fair values | ||
Other non-current assets (Note 5): | ||
Equity securities with readily determinable fair values | 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 | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenues | ||||
Total revenues | $ 595,261 | $ 341,572 | $ 1,043,062 | $ 648,198 |
Collaboration | ||||
Revenues | ||||
Total revenues | 41,516 | 37,061 | 79,026 | 82,114 |
Research and development service revenue | ||||
Revenues | ||||
Total revenues | 13,563 | 10,813 | 20,380 | 24,240 |
Right to access intellectual property revenue | ||||
Revenues | ||||
Total revenues | 26,248 | 26,248 | 52,497 | 52,497 |
Other | ||||
Revenues | ||||
Total revenues | $ 1,705 | $ 0 | $ 6,149 | $ 5,377 |
Collaborative and Licensing A_4
Collaborative and Licensing Arrangements - Novartis (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2023 USD ($) performance_obligation | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) performance_obligation | Jun. 30, 2022 USD ($) | Dec. 31, 2022 performance_obligation | Jan. 31, 2022 USD ($) | Jan. 31, 2021 USD ($) | |
Research and Development Arrangement, Contract to Perform for Others | |||||||
Total revenues | $ 595,261 | $ 341,572 | $ 1,043,062 | $ 648,198 | |||
Research and development service revenue | |||||||
Research and Development Arrangement, Contract to Perform for Others | |||||||
Total revenues | 13,563 | 10,813 | 20,380 | 24,240 | |||
License revenue | |||||||
Research and Development Arrangement, Contract to Perform for Others | |||||||
Remaining performance obligation | 71,980 | 71,980 | |||||
Tislelizumab | |||||||
Research and Development Arrangement, Contract to Perform for Others | |||||||
Total revenues | $ 1,344 | 0 | $ 5,013 | 5,377 | |||
Novartis | |||||||
Research and Development Arrangement, Contract to Perform for Others | |||||||
Number of performance obligations | performance_obligation | 1 | 1 | 2 | ||||
Novartis | Research and development service revenue | |||||||
Research and Development Arrangement, Contract to Perform for Others | |||||||
Total revenues | $ 11,770 | 9,021 | $ 16,796 | 20,656 | |||
Novartis | Collaborative Arrangement | |||||||
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 | |||||
Novartis | Collaborative Arrangement | 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 | $ 1,792 | $ 1,792 | $ 3,583 | $ 3,584 | |||
Novartis | Collaborative Arrangement | License revenue | |||||||
Research and Development Arrangement, Contract to Perform for Others | |||||||
Remaining performance obligation | 484,646 | ||||||
Novartis | Collaborative Arrangement | 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 | 6 Months Ended | |||||
Jun. 30, 2023 USD ($) trial | Jun. 30, 2022 USD ($) | Mar. 31, 2022 product | Jun. 30, 2023 USD ($) trial | Jun. 30, 2022 USD ($) | Jan. 31, 2022 USD ($) | Jan. 31, 2021 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Number of products | product | 5 | ||||||
Total revenues | $ 595,261 | $ 341,572 | $ 1,043,062 | $ 648,198 | |||
Number of ongoing trials | trial | 2 | 2 | |||||
License revenue | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Remaining performance obligation | $ 71,980 | $ 71,980 | |||||
Other | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Remaining performance obligation | 213,450 | 213,450 | |||||
Total revenues | 1,705 | 0 | 6,149 | 5,377 | |||
Research and development service revenue | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Total revenues | 13,563 | 10,813 | 20,380 | 24,240 | |||
Right to access intellectual property revenue | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Total revenues | 26,248 | 26,248 | 52,497 | 52,497 | |||
Novartis | Research and development service revenue | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Total revenues | 11,770 | 9,021 | 16,796 | 20,656 | |||
Novartis | Right to access intellectual property revenue | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Total revenues | 1,861 | 2,636 | |||||
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 | |||||||
Remaining performance obligation | 14,570 | 14,570 | $ 165,354 | ||||
Total revenues | $ 1,792 | $ 1,792 | $ 3,583 | $ 3,584 | |||
Novartis | Collaborative Arrangement | United States | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Collaborative arrangement co detailing and co-field (as a percent) | 5,000% | ||||||
Novartis | Collaborative Arrangement | MEXICO | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Collaborative arrangement co detailing and co-field (as a percent) | 2,500% | ||||||
Novartis | Collaborative Arrangement | CANADA | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||
Collaborative arrangement co detailing and co-field (as a 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) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | |
Jan. 02, 2020 USD ($) director $ / shares shares | Sep. 30, 2021 USD ($) shares | Jun. 30, 2023 USD ($) product | |
Ordinary Shares | |||
Research and Development Arrangement, Contract to Perform for Others | |||
Share price, ADS (in dollars per share) | $ / shares | $ 132.74 | ||
Proceeds from ADS (in shares) | $ 2,109,902 | ||
Amgen, Inc | Beigene Ltd | |||
Research and Development Arrangement, Contract to Perform for Others | |||
Minority interest in investment (as a percent) | 20.50% | ||
Product Revenue | Product Concentration Risk | Amgen, Inc | |||
Research and Development Arrangement, Contract to Perform for Others | |||
Concentration risk, percentage (as a percent) | 100% | ||
Amgen, Inc | |||
Research and Development Arrangement, Contract to Perform for Others | |||
Number of products company has the right to retain | product | 1 | ||
Product retention period | 5 years | ||
Maximum cash and service commitment | $ 1,250,000 | ||
Shares issued (in shares) | shares | 15,895,001 | 2,151,877 | |
Per share acquisition price (in dollars per share) | $ / shares | $ 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 | ||
Number of members of board of directors company can designate | director | 1 | ||
Amgen, Inc | Minimum | |||
Research and Development Arrangement, Contract to Perform for Others | |||
Commercialization term (in years) | 5 years | ||
Amgen, Inc | Maximum | |||
Research and Development Arrangement, Contract to Perform for Others | |||
Commercialization term (in years) | 7 years |
Collaborative and Licensing A_7
Collaborative and Licensing Arrangements - Funding Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Research and Development Arrangement, Contract to Perform for Others | ||||
Research and development expense | $ 422,764 | $ 378,207 | $ 831,348 | $ 768,122 |
Amgen, Inc | ||||
Research and Development Arrangement, Contract to Perform for Others | ||||
Research and development expense | 5,457 | 24,393 | 23,274 | 46,789 |
Amortization of research and development cost share liability | 5,271 | 23,764 | 22,669 | 45,583 |
Total amount due to Amgen for BeiGene's portion of the development funding | 10,728 | $ 48,157 | 45,943 | $ 92,372 |
Remaining portion of development funding cap | $ 549,765 | $ 549,765 |
Collaborative and Licensing A_8
Collaborative and Licensing Arrangements - Financing Liability (Details) - Amgen, Inc - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Research and Development Arrangement, Contract to Perform for Others | ||
Research and development cost share liability, current portion | $ 62,516 | $ 114,335 |
Research and development cost share liability, non-current portion | 208,775 | 179,625 |
Total research and development cost share liability | $ 271,291 | $ 293,960 |
Collaborative and Licensing A_9
Collaborative and Licensing Arrangements - Amounts and Classification of Payments (Income/(Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Research and Development Arrangement, Contract to Perform for Others | |||||
Total | $ (15,310) | $ (10,555) | $ (26,893) | $ (22,266) | |
Accounts receivable, net | 299,282 | 299,282 | $ 173,168 | ||
Accounts payable | 266,975 | 266,975 | 294,781 | ||
Amgen, Inc | Collaborative Arrangement | |||||
Research and Development Arrangement, Contract to Perform for Others | |||||
Collaborative arrangement, inventory purchases | 20,146 | 22,462 | 39,277 | 30,061 | |
Amgen, Inc | Collaborative Arrangement | Related Party | |||||
Research and Development Arrangement, Contract to Perform for Others | |||||
Accounts receivable, net | 11,069 | 11,069 | |||
Accounts payable | $ 54,064 | ||||
Cost of sales - product | |||||
Research and Development Arrangement, Contract to Perform for Others | |||||
Total | 4,011 | 2,449 | 1,184 | 3,478 | |
Research and development | |||||
Research and Development Arrangement, Contract to Perform for Others | |||||
Total | (1,769) | 657 | 1,311 | 898 | |
Selling, general and administrative | |||||
Research and Development Arrangement, Contract to Perform for Others | |||||
Total | $ (17,552) | $ (13,661) | $ (29,388) | $ (26,642) |
Restricted Cash and Investmen_3
Restricted Cash and Investments - Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Investments, Debt and Equity Securities [Abstract] | ||
Restricted cash | $ 11,206 | $ 5,473 |
Restricted Cash and Investmen_4
Restricted Cash and Investments - Short-Term Investments (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Short-term investments | ||
Amortized Cost | $ 107,802 | $ 674,262 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 2,109 | 9,011 |
Fair Value (Net Carrying Amount) | 105,693 | 665,251 |
U.S. Treasury securities | ||
Short-term investments | ||
Amortized Cost | 107,802 | 674,262 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 2,109 | 9,011 |
Fair Value (Net Carrying Amount) | $ 105,693 | $ 665,251 |
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 | 6 Months Ended | ||||
Sep. 30, 2021 | Jan. 31, 2020 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Schedule of Investments | |||||||
Unrealized losses on equity investments | $ (2,178) | $ (23,529) | |||||
Equity securities without readily determinable fair values | $ 59,209 | 59,209 | $ 57,054 | ||||
Gain on investment | 0 | $ 366 | 1,081 | 366 | |||
Equity method investment | 30,020 | 30,020 | $ 27,710 | ||||
U.S. Treasury securities | |||||||
Schedule of Investments | |||||||
Allowance for credit loss | 0 | 0 | |||||
Other Income | |||||||
Schedule of Investments | |||||||
Unrealized losses on equity investments | $ (2,480) | (647) | $ (2,624) | (1,234) | |||
Leap Therapeutic, Inc | |||||||
Schedule of Investments | |||||||
Equity method investments (as a percent) | 6.20% | 6.20% | |||||
Equity method investments, including warrants (as a percent) | 9.80% | 9.80% | |||||
Unrealized losses on equity investments | $ 470 | $ (5,908) | $ (636) | $ (22,661) | |||
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 | Jun. 30, 2023 | Dec. 31, 2022 |
Fair value of Leap common stock | ||
Schedule of Investments | ||
Equity securities with readily determinable fair values | $ 2,300 | $ 3,307 |
Fair value of Leap warrants | ||
Schedule of Investments | ||
Equity securities with readily determinable fair values | $ 1,077 | $ 706 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 109,048 | $ 88,957 |
Work in process | 31,472 | 20,886 |
Finished goods | 180,813 | 172,503 |
Total inventories | $ 321,333 | $ 282,346 |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net- Property, Plant and Equipment, Net (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Property and equipment | ||
Property, plant and equipment, at cost | $ 749,038 | $ 723,789 |
Less: accumulated depreciation | (201,406) | (171,470) |
Construction in progress | 484,306 | 293,627 |
Property, plant and equipment, net | 1,031,938 | 845,946 |
Land | ||
Property and equipment | ||
Property, plant and equipment, at cost | 65,485 | 65,485 |
Building | ||
Property and equipment | ||
Property, plant and equipment, at cost | 214,080 | 222,448 |
Manufacturing equipment | ||
Property and equipment | ||
Property, plant and equipment, at cost | 172,844 | 175,679 |
Laboratory equipment | ||
Property and equipment | ||
Property, plant and equipment, at cost | 170,424 | 158,908 |
Leasehold improvement | ||
Property and equipment | ||
Property, plant and equipment, at cost | 53,366 | 53,786 |
Software, electronics and office equipment | ||
Property and equipment | ||
Property, plant and equipment, at cost | $ 72,839 | $ 47,483 |
Property, Plant and Equipment_4
Property, Plant and Equipment, Net - Narratives (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Nov. 30, 2021 USD ($) a | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Property, Plant and Equipment | ||||||
Construction in progress | $ 484,306 | $ 484,306 | $ 293,627 | |||
Depreciation and amortization expense | 21,307 | $ 14,461 | 40,332 | $ 30,041 | ||
Land Located in Hopewell, NJ | ||||||
Property, Plant and Equipment | ||||||
Area of land (in acres) | a | 42 | |||||
Payments to acquire land | $ 75,197 | |||||
Construction in progress | $ 314,707 | $ 314,707 |
Intangible Assets - Intangible
Intangible Assets - Intangible Assets Outstanding (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Finite-lived intangible assets: | ||
Gross carrying amount | $ 57,704 | $ 49,551 |
Accumulated amortization | (10,809) | (8,935) |
Total | 46,895 | 40,616 |
Product distribution rights | ||
Finite-lived intangible assets: | ||
Gross carrying amount | 7,500 | 7,500 |
Accumulated amortization | (4,375) | (4,000) |
Total | 3,125 | 3,500 |
Developed products | ||
Finite-lived intangible assets: | ||
Gross carrying amount | 49,388 | 41,235 |
Accumulated amortization | (5,618) | (4,119) |
Total | 43,770 | 37,116 |
Trading license | ||
Finite-lived intangible assets: | ||
Gross carrying amount | 816 | 816 |
Accumulated amortization | (816) | (816) |
Total | $ 0 | $ 0 |
Intangible Assets - Narrative (
Intangible Assets - Narrative (Details) | Jun. 30, 2023 |
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 | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Finite-Lived Intangible Assets | ||||
Amortization of intangible assets | $ 1,028 | $ 1,000 | $ 2,014 | $ 2,020 |
Cost of sales - product | ||||
Finite-Lived Intangible Assets | ||||
Amortization of intangible assets | 840 | 812 | 1,639 | 1,644 |
Operating Expenses | ||||
Finite-Lived Intangible Assets | ||||
Amortization of intangible assets | $ 188 | $ 188 | $ 375 | $ 376 |
Intangible Assets - Expected Am
Intangible Assets - Expected Amortization Expense (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Acquired Finite-Lived Intangible Assets | ||
2023 (remainder of year) | $ 2,232 | |
2024 | 4,464 | |
2025 | 4,464 | |
2026 | 4,464 | |
2027 | 4,214 | |
2028 and thereafter | 27,057 | |
Total | 46,895 | $ 40,616 |
Cost of sales - product | ||
Acquired Finite-Lived Intangible Assets | ||
2023 (remainder of year) | 1,857 | |
2024 | 3,714 | |
2025 | 3,714 | |
2026 | 3,714 | |
2027 | 3,714 | |
2028 and thereafter | 27,057 | |
Total | 43,770 | |
Operating Expenses | ||
Acquired Finite-Lived Intangible Assets | ||
2023 (remainder of year) | 375 | |
2024 | 750 | |
2025 | 750 | |
2026 | 750 | |
2027 | 500 | |
2028 and thereafter | 0 | |
Total | $ 3,125 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income taxes | ||||
Income tax expense | $ 13,674 | $ 8,141 | $ 25,166 | $ 22,090 |
Unrecognized tax benefits | 12,524 | 12,524 | ||
Increase in uncertain tax position | $ 559 | $ 969 |
Supplemental Balance Sheet In_3
Supplemental Balance Sheet Information - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Prepaid expenses and other current assets | ||
Prepaid research and development costs | $ 72,391 | $ 71,488 |
Prepaid manufacturing cost | 69,319 | 58,950 |
Prepaid taxes | 18,485 | 20,478 |
Other receivables | 36,866 | 22,777 |
Interest receivable | 1,992 | 3,039 |
Prepaid insurance | 7,593 | 3,664 |
Short-term deposit for sales rebates | 7,198 | 1,510 |
Other current assets | 41,206 | 34,647 |
Total | $ 255,050 | $ 216,553 |
Supplemental Balance Sheet In_4
Supplemental Balance Sheet Information - Other Non-current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Other non-current assets | ||
Goodwill | $ 109 | $ 109 |
Prepayment of property and equipment | 13,140 | 22,025 |
Prepaid supply cost | 30,539 | 48,642 |
Prepaid VAT | 1,734 | 804 |
Rental deposits and other | 6,420 | 7,054 |
Long-term investments | 95,607 | 91,779 |
Total | $ 147,549 | $ 170,413 |
Supplemental Balance Sheet In_5
Supplemental Balance Sheet Information - Accrued Expenses and Other Payables (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Accrued expenses and other payables | ||
Compensation related | $ 135,719 | $ 184,775 |
External research and development activities related | 91,108 | 139,168 |
Commercial activities | 65,506 | 51,806 |
Individual income tax and other taxes | 38,486 | 18,815 |
Sales rebates and returns related | 85,591 | 41,817 |
Other | 38,540 | 30,971 |
Total | $ 454,950 | $ 467,352 |
Supplemental Balance Sheet In_6
Supplemental Balance Sheet Information - Other Long-term Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Other long-term liabilities | ||
Deferred government grant income | $ 34,865 | $ 38,176 |
Pension liability | 7,996 | 7,760 |
Other | 257 | 159 |
Total | $ 43,118 | $ 46,095 |
Debt - Short-term and Long-term
Debt - Short-term and Long-term Debt Obligations (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||||||
Jul. 22, 2022 CNY (¥) | Jan. 22, 2020 CNY (¥) | Jun. 30, 2023 USD ($) | Jun. 30, 2023 CNY (¥) | Jun. 30, 2023 USD ($) | Jun. 30, 2023 CNY (¥) | Jun. 30, 2022 USD ($) | Jun. 30, 2023 CNY (¥) | Dec. 31, 2022 USD ($) | Dec. 31, 2022 CNY (¥) | Dec. 31, 2021 CNY (¥) | Dec. 31, 2020 CNY (¥) | Sep. 30, 2020 USD ($) | |
Debt Instrument | |||||||||||||
Short-term debt | $ 421,052 | $ 421,052 | ¥ 3,053,095,000 | $ 328,969 | ¥ 2,268,905,000 | ||||||||
Long-term bank loans | 207,426 | 207,426 | 1,504,071,000 | 209,148 | 1,442,500,000 | ||||||||
Repayment of long-term loan | $ | 0 | $ 0 | |||||||||||
Proceeds from long-term loan | $ | 15,771 | 0 | |||||||||||
Repayment of short-term loans | $ | 66,574 | $ 115,405 | |||||||||||
Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Short-term debt | 120,534 | $ 120,534 | 874,000,000 | 114,832 | 792,000,000 | ||||||||
China Industrial Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Line of Credit | 875,000,000 | ¥ 875,000,000 | |||||||||||
Interest Rate | 2.60% | 2.60% | |||||||||||
Proceeds from long-term loan | $ 28,174 | ¥ 199,000,000 | |||||||||||
Repayment of short-term loans | 16,574 | ¥ 117,000,000 | |||||||||||
Short-Term Debt April 4, 2018 | China Construction Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Line of Credit | 580,000 | ||||||||||||
Short-term debt | 10,343 | $ 10,343 | 75,000,000 | 7,250 | 50,000,000 | ||||||||
Repayment of long-term loan | 3,483 | ¥ 25,000,000 | |||||||||||
Short-Term Debt April 4, 2018 | China Merchants Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Term | 9 years | 9 years | |||||||||||
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 | 9 years | ||||||||||
Interest Rate | 4.10% | 4.10% | |||||||||||
Short-term debt | 5,024 | $ 5,024 | 36,429,000 | 1,450 | 10,000,000 | ||||||||
Repayment of long-term loan | $ 731 | ¥ 5,000,000 | |||||||||||
Short-Term Debt Dated November 9 2020 | China Merchants Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Repayment of long-term loan | 2,518 | ¥ 17,500,000 | |||||||||||
Short-Term Debt Dated November 9 2020 | China Merchants Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Line of Credit | 378,000,000 | ||||||||||||
Term | 9 years | 9 years | |||||||||||
Short-term debt | 5,516 | $ 5,516 | 40,000,000 | 5,437 | 37,500,000 | ||||||||
Short-Term Debt September 24, 2020 | China Minsheng Bank (the “Senior Loan”) | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Line of Credit | $ | 200,000 | $ 200,000 | $ 200,000 | ||||||||||
Interest Rate | 4.30% | 4.30% | |||||||||||
Short-term debt | 150,000 | $ 150,000 | 1,087,666,000 | 150,000 | 1,034,554,000 | ||||||||
Short-Term Debt February 25 2022 | Shanghai Pudong Development Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Line of Credit | $ | 50,000 | $ 50,000 | |||||||||||
Term | 1 year | 1 year | |||||||||||
Interest Rate | 2.20% | 2.20% | |||||||||||
Short-term debt | 0 | $ 0 | 0 | 50,000 | 344,851,000 | ||||||||
Short Term Bank Loan Dated June 5 2023 | China Merchants Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Line of Credit | 400,000 | ||||||||||||
Interest Rate | 3.20% | 3.20% | |||||||||||
Short-term debt | 55,164 | $ 55,164 | 400,000,000 | 0 | 0 | ||||||||
Short Term Bank Loan Dated June 5 2023 | Shanghai Pudong Development Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Term | 1 year | 1 year | |||||||||||
Short Term Bank Loan Dated May 4 2023 | Shanghai Pudong Development Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Term | 1 year | 1 year | |||||||||||
Short Term Bank Loan Dated May 4 2023 | HSBC Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Line of Credit | 340,000 | ||||||||||||
Interest Rate | 4.70% | 4.70% | |||||||||||
Short-term debt | 46,889 | $ 46,889 | 340,000,000 | 0 | 0 | ||||||||
Short Term Bank Loan Dated May 30 2023 | Shanghai Pudong Development Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Term | 1 year | 1 year | |||||||||||
Short Term Bank Loan Dated May 30 2023 | China Industrial Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Line of Credit | 200,000 | ||||||||||||
Interest Rate | 2.80% | 2.80% | |||||||||||
Short-term debt | 27,582 | $ 27,582 | 200,000,000 | 0 | 0 | ||||||||
Long-Term Bank April 4, 2018 | China Construction Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Line of Credit | 580,000 | ||||||||||||
Interest Rate | 4.50% | 4.50% | |||||||||||
Long-term bank loans | 64,818 | $ 64,818 | 470,000,000 | 75,395 | 520,000,000 | ||||||||
Long-Term Bank April 4, 2018 | China CITIC Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Term | 9 years | 9 years | |||||||||||
Long-Term Bank January 22, 2020 | China Merchants Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Long-term bank loans | 41,176 | $ 41,176 | 298,571,000 | 47,847 | 330,000,000 | ||||||||
Long-Term Bank January 22, 2020 | China CITIC Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Term | 9 years | 9 years | |||||||||||
Long Term Bank Loan Dated November 9 2020 | China Merchants Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Line of Credit | 378,000 | ||||||||||||
Long-term bank loans | $ 44,200 | $ 44,200 | ¥ 320,500,000 | 49,369 | 340,500,000 | ||||||||
Long Term Bank Loan Dated November 9 2020 | China CITIC Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Term | 9 years | 9 years | |||||||||||
Long Term Bank Loan Dated July 29, 2022 | China Merchants Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Fixed annual interest rate (as a percent) | 4.10% | 4.10% | 4.10% | ||||||||||
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 | 10 years | ||||||||||
Long-term bank loans | $ 57,232 | $ 57,232 | ¥ 415,000,000 | $ 36,537 | ¥ 252,000,000 | ||||||||
Proceeds from long-term loan | $ 22,502 | ¥ 163,000,000 |
Debt - Narratives (Details)
Debt - Narratives (Details) | 3 Months Ended | 6 Months Ended | |||||||||||
Jul. 22, 2022 CNY (¥) | Oct. 08, 2021 option | Jan. 22, 2020 CNY (¥) | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2023 CNY (¥) | Jun. 30, 2022 USD ($) | Jun. 30, 2023 CNY (¥) | Dec. 31, 2022 CNY (¥) | Dec. 31, 2021 CNY (¥) | Dec. 31, 2020 CNY (¥) | Sep. 30, 2020 USD ($) | |
Debt Instrument | |||||||||||||
Repayment of long-term loan | $ 0 | $ 0 | |||||||||||
Interest expense | $ 4,891,000 | $ 5,456,000 | 9,465,000 | 10,984,000 | |||||||||
Interest capitalized | 428,000 | $ 654,000 | $ 772,000 | $ 1,935,000 | |||||||||
China Industrial Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Interest rate (as a percent) | 2.60% | 2.60% | |||||||||||
Line of credit | ¥ | ¥ 875,000,000 | ¥ 875,000,000 | |||||||||||
Long-Term Bank April 4, 2018 | China Construction Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Interest rate (as a percent) | 4.50% | 4.50% | |||||||||||
Line of credit | ¥ | ¥ 580,000 | ||||||||||||
Long-Term Bank April 4, 2018 | China CITIC Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Debt instrument term (in years) | 9 years | 9 years | |||||||||||
Short-Term Debt January 22 2020 | China Merchants Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Interest rate (as a percent) | 4.10% | 4.10% | |||||||||||
Repayment of long-term loan | $ 731,000 | ¥ 5,000,000 | |||||||||||
Debt instrument term (in years) | 9 years | 9 years | 9 years | ||||||||||
Line of credit | ¥ | ¥ 1,100,000,000 | ¥ 350,000,000 | |||||||||||
Short-Term Debt September 24, 2020 | China Minsheng Bank (the “Senior Loan”) | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Interest rate (as a percent) | 4.30% | 4.30% | |||||||||||
Line of credit | $ 200,000,000 | $ 200,000,000 | $ 200,000,000 | ||||||||||
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 | ||||||||||||
Senior Loan | China Minsheng Bank (the “Senior Loan”) | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Extension options (option) | option | 2 | ||||||||||||
Extension period (month) | 12 months | ||||||||||||
Long Term Bank Loan Dated July 29, 2022 | China Merchants Bank | Loans Payable | |||||||||||||
Debt Instrument | |||||||||||||
Fixed annual interest rate (as a percent) | 4.10% | 4.10% | 4.10% | ||||||||||
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 |
Product Revenue - Product Sales
Product Revenue - Product Sales (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenues | ||||
Product revenue – net | $ 595,261 | $ 341,572 | $ 1,043,062 | $ 648,198 |
Product | ||||
Revenues | ||||
Product revenue – gross | 667,328 | 342,885 | 1,176,933 | 638,273 |
Less: Rebates and sales returns | (113,583) | (38,374) | (212,897) | (72,189) |
Product revenue – net | 553,745 | 304,511 | 964,036 | 566,084 |
Product | BRUKINSA® | ||||
Revenues | ||||
Product revenue – net | 308,276 | 128,747 | 519,658 | 233,072 |
Product | Tislelizumab | ||||
Revenues | ||||
Product revenue – net | 149,464 | 104,879 | 264,314 | 192,522 |
Product | REVLIMID® | ||||
Revenues | ||||
Product revenue – net | 21,847 | 19,916 | 45,005 | 41,576 |
Product | XGEVA® | ||||
Revenues | ||||
Product revenue – net | 23,968 | 15,509 | 44,165 | 29,008 |
Product | POBEVCY® | ||||
Revenues | ||||
Product revenue – net | 13,438 | 12,983 | 27,764 | 19,798 |
Product | BLINCYTO® | ||||
Revenues | ||||
Product revenue – net | 14,578 | 9,530 | 25,524 | 21,396 |
Product | KYPROLIS® | ||||
Revenues | ||||
Product revenue – net | 11,052 | 4,092 | 15,995 | 8,405 |
Product | VIDAZA® | ||||
Revenues | ||||
Product revenue – net | 3,930 | 3,434 | 7,119 | 8,946 |
Product | Pamiparib | ||||
Revenues | ||||
Product revenue – net | 1,919 | 2,022 | 3,725 | 4,577 |
Product | Other | ||||
Revenues | ||||
Product revenue – net | $ 5,273 | $ 3,399 | $ 10,767 | $ 6,784 |
Product Revenue - Accrued Sales
Product Revenue - Accrued Sales Rebates and Returns (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Accrued Sales Rebates and Returns | ||
Balance at end of the period | $ 85,591 | |
Product | ||
Accrued Sales Rebates and Returns | ||
Balance at beginning of the period | 41,817 | $ 59,639 |
Accrual | 212,897 | 72,189 |
Payments | (169,123) | (60,316) |
Balance at end of the period | $ 85,591 | $ 71,512 |
Loss Per Share (Details)
Loss Per Share (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Numerator: | ||||||
Net loss | $ (381,137) | $ (348,431) | $ (565,726) | $ (435,198) | $ (729,568) | $ (1,000,924) |
Denominator: | ||||||
Weighted average shares outstanding—basic (in shares) | 1,360,224,377 | 1,336,463,026 | 1,357,211,308 | 1,334,252,648 | ||
Weighted average shares outstanding - diluted (in shares) | 1,360,224,377 | 1,336,463,026 | 1,357,211,308 | 1,334,252,648 |
Share-Based Compensation Expe_3
Share-Based Compensation Expense - Narrative (Details) - shares | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Dec. 31, 2018 | Jun. 30, 2018 | Mar. 31, 2022 | Jun. 30, 2023 | Jan. 31, 2016 | |
2016 Plan | ||||||
Share-based compensation | ||||||
Number of shares reserved and available for issuance (in shares) | 65,029,595 | |||||
Increase in ordinary shares authorized (in shares) | 57,200,000 | 38,553,159 | 66,300,000 | |||
Shares available for future grants (in shares) | 38,873,106 | |||||
Percentage of shares reserved and available for issuance (as a percent) | 5% | |||||
2016 Plan | Share Options | ||||||
Share-based compensation | ||||||
Granted (in shares) | 9,396,660 | |||||
Number of options outstanding (in shares) | 64,070,175 | |||||
2016 Plan | Restricted Share Units (RSUs) | ||||||
Share-based compensation | ||||||
Granted (in shares) | 29,453,021 | |||||
Number of options outstanding (in shares) | 68,073,668 | |||||
2011 Plan | ||||||
Share-based compensation | ||||||
Shares cancelled or forfeited (in shares) | 5,166,822 | |||||
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) | 0 | |||||
Employee Share Purchase Plan 2018 | ||||||
Share-based compensation | ||||||
Number of shares reserved and available for issuance (in shares) | 7,355,315 | 3,500,000 | ||||
Increase in ordinary shares authorized (in shares) | 3,855,315 | |||||
Shares available for future grants (in shares) | 2,735,219 | |||||
Offering period (in months) | 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 | Feb. 28, 2023 | Aug. 31, 2022 | Feb. 28, 2022 |
Share-based Compensation Arrangement by Share-based Payment Award | |||
Number of Ordinary Shares Issued ( in shares) | 930,582 | 861,315 | 667,160 |
Market Price, ADS (in dollars per share) | $ 171.10 | $ 171.66 | $ 210.52 |
Market Price, Ordinary (in dollars per share) | 13.16 | 13.20 | 16.19 |
Purchase Price, ADS (in dollars per share) | 145.44 | 145.91 | 178.94 |
Purchase Price, Ordinary (in dollars per share) | $ 11.19 | $ 11.22 | $ 13.76 |
Proceeds | $ 10,414 | $ 9,667 | $ 9,183 |
Share-Based Compensation Expe_5
Share-Based Compensation Expense - Expense Recognized (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-based compensation | ||||
Compensation expense | $ 103,329 | $ 81,305 | $ 178,717 | $ 110,624 |
Research and development | ||||
Share-based compensation | ||||
Compensation expense | 45,948 | 37,107 | 79,976 | 52,082 |
Selling, general and administrative | ||||
Share-based compensation | ||||
Compensation expense | $ 57,381 | $ 44,198 | $ 98,741 | $ 58,542 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | |
Movement in accumulated other comprehensive loss | |||||
Balance at the beginning of period | $ 4,157,306 | $ 4,383,355 | $ 5,774,152 | $ 6,132,563 | $ 4,383,355 |
Other comprehensive (loss) income before reclassifications | (66,270) | ||||
Net-current period other comprehensive (loss) income | (84,673) | 18,403 | (99,904) | (496) | (66,270) |
Balance at the end of period | 3,798,559 | 4,157,306 | 5,196,919 | 5,774,152 | 3,798,559 |
Accumulated Other Comprehensive Loss | |||||
Movement in accumulated other comprehensive loss | |||||
Balance at the beginning of period | (59,014) | (77,417) | 17,454 | 17,950 | (77,417) |
Net-current period other comprehensive (loss) income | (84,673) | 18,403 | (99,904) | (496) | |
Balance at the end of period | (143,687) | (59,014) | $ (82,450) | $ 17,454 | (143,687) |
Foreign Currency Translation Adjustments | |||||
Movement in accumulated other comprehensive loss | |||||
Balance at the beginning of period | (62,523) | (62,523) | |||
Other comprehensive (loss) income before reclassifications | (73,172) | ||||
Net-current period other comprehensive (loss) income | (73,172) | ||||
Balance at the end of period | (135,695) | (135,695) | |||
Unrealized Gains (Losses) on Available-for-Sale Securities | |||||
Movement in accumulated other comprehensive loss | |||||
Balance at the beginning of period | (9,011) | (9,011) | |||
Other comprehensive (loss) income before reclassifications | 6,902 | ||||
Net-current period other comprehensive (loss) income | 6,902 | ||||
Balance at the end of period | (2,109) | (2,109) | |||
Pension Liability Adjustments | |||||
Movement in accumulated other comprehensive loss | |||||
Balance at the beginning of period | $ (5,883) | (5,883) | |||
Other comprehensive (loss) income before reclassifications | 0 | ||||
Net-current period other comprehensive (loss) income | 0 | ||||
Balance at the end of period | $ (5,883) | $ (5,883) |
Shareholders_ Equity (Details)
Shareholders’ Equity (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | |||
Jan. 02, 2020 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) shares | Dec. 31, 2021 ¥ / shares | |
Amgen, Inc | ||||
Subsidiary, Sale of Stock | ||||
Stock issued during period, shares, new issues, american depository (in shares) | 165,529 | |||
Shares issued (in shares) | 15,895,001 | 2,151,877 | ||
Proceeds from sale of ordinary shares, net of cost | $ | $ 2,779,241 | $ 50 | ||
Per share acquisition price (in dollars per share) | $ / shares | $ 174.85 | |||
STAR Market | IPO | ||||
Subsidiary, Sale of Stock | ||||
Shares issued (in shares) | 115,055,260 | |||
Proceeds from sale of ordinary shares, net of cost | $ | $ 3,392,616 | |||
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 | Jun. 30, 2023 | Dec. 31, 2022 |
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 | $ 3,305,583 | $ 3,548,881 |
Commitments and Contingencies -
Commitments and Contingencies - Commitments (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2023 USD ($) investment | |
Purchase and Capital commitments | |
Purchase commitments | $ 104,115 |
Investments Funding Commitment | |
Purchase and Capital commitments | |
Other commitments | $ 10,557 |
Number of equity investments (investment) | investment | 2 |
Maximum commitment | $ 15,057 |
Pension Commitment | |
Purchase and Capital commitments | |
Employer contributions | 2,627 |
Research and Development Arrangement | |
Purchase and Capital commitments | |
Other commitments | $ 17,990 |
Commitment term (in years) | 4 years |
Amgen, Inc | |
Purchase and Capital commitments | |
Other commitments | $ 549,765 |
Maximum cash and service commitment | 1,250,000 |
Minimum Purchase Commitments For Supply Purchased | |
Purchase and Capital commitments | |
Purchase commitments | 40,295 |
Inventories | |
Purchase and Capital commitments | |
Purchase commitments | 63,820 |
Capital Addition Purchase Commitments | |
Purchase and Capital commitments | |
Other commitments | $ 381,187 |
Segment and Geographic Inform_3
Segment and Geographic Information - Narratives (Details) | 6 Months Ended |
Jun. 30, 2023 segment | |
Segment Reporting [Abstract] | |
Number of operating segments | 1 |
Segment and Geographic Inform_4
Segment and Geographic Information - Revenue by Geographic Area (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Net product revenues by geographic area | ||||
Total | $ 595,261 | $ 341,572 | $ 1,043,062 | $ 648,198 |
Product revenue, net | ||||
Net product revenues by geographic area | ||||
Total | 553,745 | 304,511 | 964,036 | 566,084 |
Product revenue, net | PRC | ||||
Net product revenues by geographic area | ||||
Total | 293,919 | 212,429 | 540,828 | 403,164 |
Product revenue, net | United States | ||||
Net product revenues by geographic area | ||||
Total | 223,540 | 88,381 | 362,307 | 156,269 |
Product revenue, net | Rest of world | ||||
Net product revenues by geographic area | ||||
Total | 36,286 | 3,701 | 60,901 | 6,651 |
Collaboration revenue | ||||
Net product revenues by geographic area | ||||
Total | 41,516 | 37,061 | 79,026 | 82,114 |
Collaboration revenue | PRC | ||||
Net product revenues by geographic area | ||||
Total | 1,861 | 0 | 2,636 | 0 |
Collaboration revenue | United States | ||||
Net product revenues by geographic area | ||||
Total | 28,809 | 25,943 | 54,523 | 57,480 |
Collaboration revenue | Rest of world | ||||
Net product revenues by geographic area | ||||
Total | $ 10,846 | $ 11,118 | $ 21,867 | $ 24,634 |
Subsequent Event (Details)
Subsequent Event (Details) $ in Millions | Jul. 28, 2023 USD ($) |
Subsequent Event | Unsecured Debt | Credit Agreement | |
Subsequent Event | |
Line of credit | $ 400 |