Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2020 | Oct. 31, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2020 | |
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 $0.0001 per share | |
Trading Symbol(s) | BGNE | |
Name of each exchange on which registered | NASDAQ | |
Entity Common Stock, Shares Outstanding | 1,182,916,659 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0001651308 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 1,464,470 | $ 618,011 |
Short-term restricted cash | 295 | 288 |
Short-term investments | 3,254,300 | 364,728 |
Accounts receivable, net | 60,266 | 70,878 |
Inventories | 35,525 | 28,553 |
Prepaid expenses and other current assets | 150,880 | 90,238 |
Total current assets | 4,965,736 | 1,172,696 |
Long-term restricted cash | 4,950 | 2,476 |
Property, plant and equipment, net | 291,218 | 242,402 |
Operating lease right-of-use assets | 88,689 | 82,520 |
Intangible assets, net | 5,188 | 5,846 |
Deferred tax assets | 48,009 | 37,894 |
Other non-current assets | 162,600 | 68,455 |
Total non-current assets | 600,654 | 439,593 |
Total assets | 5,566,390 | 1,612,289 |
Current liabilities: | ||
Accounts payable | 146,265 | 122,488 |
Accrued expenses and other payables | 279,323 | 163,556 |
Tax payable | 9,244 | 13,454 |
Operating lease liabilities, current portion | 13,280 | 10,814 |
Research and development cost share liability, current portion | 147,387 | 0 |
Short-term debt | 50,222 | 0 |
Total current liabilities | 645,721 | 310,312 |
Non-current liabilities: | ||
Long-term debt | 151,551 | 83,311 |
Shareholder loan | 0 | 157,384 |
Operating lease liabilities, non-current portion | 28,679 | 25,833 |
Deferred tax liabilities | 11,884 | 10,532 |
Research and development cost share liability, non-current portion | 384,151 | 0 |
Other long-term liabilities | 47,890 | 46,562 |
Total non-current liabilities | 624,155 | 323,622 |
Total liabilities | 1,269,876 | 633,934 |
Commitments and contingencies | ||
Equity: | ||
Ordinary shares, US$0.0001 par value per share; 9,500,000,000 shares authorized; 1,182,916,659 and 801,340,698 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively | 118 | 79 |
Additional paid-in capital | 7,367,799 | 2,925,970 |
Accumulated other comprehensive loss | (419) | (8,001) |
Accumulated deficit | (3,080,004) | (1,955,843) |
Total BeiGene, Ltd. shareholders’ equity | 4,287,494 | 962,205 |
Noncontrolling interest | 9,020 | 16,150 |
Total equity | 4,296,514 | 978,355 |
Total liabilities and equity | $ 5,566,390 | $ 1,612,289 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
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) | 1,182,916,659 | 801,340,698 |
Ordinary shares, shares outstanding (in shares) | 1,182,916,659 | 801,340,698 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenues | ||||
Revenues | $ 91,080,000 | $ 50,141,000 | $ 208,774,000 | $ 371,320,000 |
Expenses | ||||
Cost of sales - product | 21,123,000 | 20,106,000 | 49,579,000 | 53,206,000 |
Research and development | 349,070,000 | 236,968,000 | 939,340,000 | 644,079,000 |
Selling, general and administrative | 160,837,000 | 105,002,000 | 391,967,000 | 244,895,000 |
Amortization of intangible assets | 187,000 | 331,000 | 658,000 | 994,000 |
Total expenses | 531,217,000 | 362,407,000 | 1,381,544,000 | 943,174,000 |
Loss from operations | (440,137,000) | (312,266,000) | (1,172,770,000) | (571,854,000) |
Interest (expense) income, net | (614,000) | 2,206,000 | 7,184,000 | 9,569,000 |
Other income (expense), net | 5,711,000 | (1,817,000) | 29,368,000 | (967,000) |
Loss before income taxes | (435,040,000) | (311,877,000) | (1,136,218,000) | (563,252,000) |
Income tax benefit | (8,423,000) | (3,217,000) | (8,344,000) | (569,000) |
Net loss | (426,617,000) | (308,660,000) | (1,127,874,000) | (562,683,000) |
Less: net loss attributable to noncontrolling interests | (1,393,000) | (1,303,000) | (3,713,000) | (2,116,000) |
Net loss attributable to BeiGene, Ltd. | $ (425,224,000) | $ (307,357,000) | $ (1,124,161,000) | $ (560,567,000) |
Net loss per share attributable to BeiGene, Ltd., basic and diluted (in dollars per share) | $ (0.37) | $ (0.39) | $ (1.07) | $ (0.72) |
Weighted-average shares outstanding, basic and diluted (in shares) | 1,148,973,077 | 781,482,459 | 1,052,940,583 | 777,938,599 |
Net loss per American Depositary Share (“ADS”), basic and diluted (in dollars per share) | $ (4.81) | $ (5.11) | $ (13.88) | $ (9.37) |
Weighted-average ADSs outstanding, basic and diluted (in shares) | 88,382,544 | 60,114,035 | 80,995,429 | 59,841,431 |
Product revenue, net | ||||
Revenues | ||||
Revenues | $ 91,080,000 | $ 50,141,000 | $ 208,774,000 | $ 165,704,000 |
Collaboration revenue | ||||
Revenues | ||||
Revenues | $ 0 | $ 0 | $ 0 | $ 205,616,000 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||
Net loss | $ (426,617) | $ (308,660) | $ (1,127,874) | $ (562,683) |
Other comprehensive (loss)/ income, net of tax of nil: | ||||
Foreign currency translation adjustments | 10,143 | (13,670) | 7,526 | (17,252) |
Unrealized holding (loss) gain, net | (1,044) | (1,260) | 184 | 326 |
Comprehensive loss | (417,518) | (323,590) | (1,120,164) | (579,609) |
Less: comprehensive loss attributable to noncontrolling interests | (1,174) | (1,628) | (3,585) | (2,686) |
Comprehensive loss attributable to BeiGene, Ltd. | $ (416,344) | $ (321,962) | $ (1,116,579) | $ (576,923) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Operating activities: | ||
Net loss | $ (1,127,874) | $ (562,683) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 23,961 | 11,133 |
Share-based compensation expenses | 134,020 | 95,812 |
Unrealized gains on equity method investments | (9,974) | 0 |
Gain on deconsolidation of a subsidiary | (11,307) | 0 |
Acquired in-process research and development | 89,500 | 49,000 |
Amortization of research and development cost share liability | (85,296) | 0 |
Deferred income tax benefits | (8,762) | (13,334) |
Other items, net | 1,144 | (2,733) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 10,497 | (14,856) |
Inventories | (6,972) | (21,270) |
Prepaid expenses and other current assets | (52,941) | (5,653) |
Operating lease right-of-use assets | (5,207) | (4,303) |
Other non-current assets | (5,980) | (15,307) |
Accounts payable | 21,979 | (8,151) |
Accrued expenses and other payables | 115,872 | 33,494 |
Tax payable | (12,272) | 3,173 |
Deferred revenue | 0 | (27,982) |
Operating lease liabilities | 5,312 | 2,072 |
Other long-term liabilities | (26,827) | (1,500) |
Net cash used in operating activities | (951,127) | (483,088) |
Investing activities: | ||
Purchases of property, plant and equipment | (82,819) | (74,148) |
Deconsolidation of a subsidiary | (2,025) | 0 |
Purchases of investments | (4,879,705) | (850,825) |
Proceeds from sale or maturity of investments | 1,972,608 | 1,552,028 |
Purchase of in-process research and development | (89,500) | (49,000) |
Net cash (used in) provided by investing activities | (3,081,441) | 578,055 |
Financing activities: | ||
Proceeds from sale of ordinary shares, net of cost | 4,232,017 | 0 |
Proceeds from research and development cost share liability | 616,834 | 0 |
Capital contribution from noncontrolling interest | 0 | 4,000 |
Prepayment to acquire joint venture ("JV") minority interest | (28,723) | 0 |
Proceeds from long-term loans | 64,288 | 67,489 |
Repayment of long-term loans | (132,061) | (8,394) |
Proceeds from short-term loans | 48,983 | 0 |
Proceeds from option exercises and employee share purchase plan | 75,830 | 20,387 |
Net cash provided by financing activities | 4,877,168 | 83,482 |
Effect of foreign exchange rate changes, net | 4,340 | (18,339) |
Net increase in cash, cash equivalents, and restricted cash | 848,940 | 160,110 |
Cash, cash equivalents, and restricted cash at beginning of period | 620,775 | 740,713 |
Cash, cash equivalents, and restricted cash at end of period | 1,469,715 | 900,823 |
Supplemental cash flow information: | ||
Cash and cash equivalents | 1,464,470 | 856,851 |
Short-term restricted cash | 295 | 14,271 |
Long-term restricted cash | 4,950 | 30,401 |
Income taxes paid | 10,596 | 8,951 |
Interest paid | 41,577 | 3,335 |
Supplemental non-cash information: | ||
Acquisitions of equipment included in accounts payable | $ 30,926 | $ 29,255 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY - USD ($) $ in Thousands | Total | Total | Ordinary Shares | Additional Paid-In Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Noncontrolling Interests |
Balance at the beginning of period at Dec. 31, 2018 | $ 1,753,647 | $ 1,739,202 | $ 77 | $ 2,744,814 | $ 1,526 | $ (1,007,215) | $ 14,445 |
Balance at the beginning of period (in shares) at Dec. 31, 2018 | 776,263,184 | ||||||
Increase (Decrease) in Stockholders' Equity | |||||||
Issuance (use) of shares reserved for share option exercises and RSU releases (in shares) | 916,383 | ||||||
Exercise of options, ESPP and release of Restricted Share Units (RSUs) | 6,269 | 6,269 | $ 1 | 6,268 | |||
Exercise of options, ESPP and release of Restricted Share Units (RSUs) (in shares) | 2,066,383 | ||||||
Share-based compensation | 26,392 | 26,392 | 26,392 | ||||
Other comprehensive income (loss) | 4,440 | 4,546 | 4,546 | (106) | |||
Net loss | (168,069) | (167,640) | (167,640) | (429) | |||
Balance at the ending of period (in shares) at Mar. 31, 2019 | 777,413,184 | ||||||
Balance at the end of period at Mar. 31, 2019 | 1,622,679 | 1,608,769 | $ 78 | 2,777,474 | 6,072 | (1,174,855) | 13,910 |
Balance at the beginning of period at Dec. 31, 2018 | 1,753,647 | 1,739,202 | $ 77 | 2,744,814 | 1,526 | (1,007,215) | 14,445 |
Balance at the beginning of period (in shares) at Dec. 31, 2018 | 776,263,184 | ||||||
Increase (Decrease) in Stockholders' Equity | |||||||
Net loss | (562,683) | ||||||
Balance at the ending of period (in shares) at Sep. 30, 2019 | 784,440,698 | ||||||
Balance at the end of period at Sep. 30, 2019 | 1,294,237 | 1,278,478 | $ 78 | 2,861,012 | (14,830) | (1,567,782) | 15,759 |
Balance at the beginning of period at Mar. 31, 2019 | 1,622,679 | 1,608,769 | $ 78 | 2,777,474 | 6,072 | (1,174,855) | 13,910 |
Balance at the beginning of period (in shares) at Mar. 31, 2019 | 777,413,184 | ||||||
Increase (Decrease) in Stockholders' Equity | |||||||
Issuance (use) of shares reserved for share option exercises and RSU releases (in shares) | 3,223,701 | ||||||
Contributions from shareholders | 4,000 | 4,000 | |||||
Exercise of options, ESPP and release of Restricted Share Units (RSUs) | 4,373 | 4,373 | 4,373 | ||||
Exercise of options, ESPP and release of Restricted Share Units (RSUs) (in shares) | 3,802,747 | ||||||
Share-based compensation | 32,602 | 32,602 | 32,602 | ||||
Other comprehensive income (loss) | (6,436) | (6,297) | (6,297) | (139) | |||
Net loss | (85,954) | (85,570) | (85,570) | (384) | |||
Balance at the ending of period (in shares) at Jun. 30, 2019 | 784,439,632 | ||||||
Balance at the end of period at Jun. 30, 2019 | 1,571,264 | 1,553,877 | $ 78 | 2,814,449 | (225) | (1,260,425) | 17,387 |
Increase (Decrease) in Stockholders' Equity | |||||||
Issuance (use) of shares reserved for share option exercises and RSU releases (in shares) | (4,170,283) | ||||||
Exercise of options, ESPP and release of Restricted Share Units (RSUs) | 9,745 | 9,745 | 9,745 | ||||
Exercise of options, ESPP and release of Restricted Share Units (RSUs) (in shares) | 4,171,349 | ||||||
Share-based compensation | 36,818 | 36,818 | 36,818 | ||||
Other comprehensive income (loss) | (14,930) | (14,605) | (14,605) | (325) | |||
Net loss | (308,660) | (307,357) | (307,357) | (1,303) | |||
Balance at the ending of period (in shares) at Sep. 30, 2019 | 784,440,698 | ||||||
Balance at the end of period at Sep. 30, 2019 | 1,294,237 | 1,278,478 | $ 78 | 2,861,012 | (14,830) | (1,567,782) | 15,759 |
Balance at the beginning of period at Dec. 31, 2019 | $ 978,355 | 962,205 | $ 79 | 2,925,970 | (8,001) | (1,955,843) | 16,150 |
Balance at the beginning of period (in shares) at Dec. 31, 2019 | 801,340,698 | 801,340,698 | |||||
Increase (Decrease) in Stockholders' Equity | |||||||
Issuance of ordinary shares in connection with collaboration | $ 2,162,407 | 2,162,407 | $ 21 | 2,162,386 | |||
Issuance of ordinary shares in connection with collaboration (in shares) | 206,635,013 | ||||||
Issuance (use) of shares reserved for share option exercises and RSU releases (in shares) | 3,705,468 | ||||||
Exercise of options, ESPP and release of Restricted Share Units (RSUs) | 11,629 | 11,629 | $ 1 | 11,628 | |||
Exercise of options, ESPP and release of Restricted Share Units (RSUs) (in shares) | 3,706,573 | ||||||
Share-based compensation | 38,255 | 38,255 | 38,255 | ||||
Other comprehensive income (loss) | 1,349 | 1,453 | 1,453 | (104) | |||
Net loss | (364,939) | (363,735) | (363,735) | (1,204) | |||
Balance at the ending of period (in shares) at Mar. 31, 2020 | 1,007,976,816 | ||||||
Balance at the end of period at Mar. 31, 2020 | 2,827,056 | 2,812,214 | $ 101 | 5,138,239 | (6,548) | (2,319,578) | 14,842 |
Balance at the beginning of period at Dec. 31, 2019 | $ 978,355 | 962,205 | $ 79 | 2,925,970 | (8,001) | (1,955,843) | 16,150 |
Balance at the beginning of period (in shares) at Dec. 31, 2019 | 801,340,698 | 801,340,698 | |||||
Increase (Decrease) in Stockholders' Equity | |||||||
Other comprehensive income (loss) | 7,582 | ||||||
Net loss | $ (1,127,874) | ||||||
Balance at the ending of period (in shares) at Sep. 30, 2020 | 1,182,916,659 | 1,182,916,659 | |||||
Balance at the end of period at Sep. 30, 2020 | $ 4,296,514 | 4,287,494 | $ 118 | 7,367,799 | (419) | (3,080,004) | 9,020 |
Balance at the beginning of period at Mar. 31, 2020 | 2,827,056 | 2,812,214 | $ 101 | 5,138,239 | (6,548) | (2,319,578) | 14,842 |
Balance at the beginning of period (in shares) at Mar. 31, 2020 | 1,007,976,816 | ||||||
Increase (Decrease) in Stockholders' Equity | |||||||
Issuance (use) of shares reserved for share option exercises and RSU releases (in shares) | 3,493,516 | ||||||
Exercise of options, ESPP and release of Restricted Share Units (RSUs) | 16,569 | 16,569 | $ 1 | 16,568 | |||
Exercise of options, ESPP and release of Restricted Share Units (RSUs) (in shares) | 10,493,392 | ||||||
Share-based compensation | 45,468 | 45,468 | 45,468 | ||||
Deconsolidation of a subsidiary | (3,545) | (3,545) | |||||
Other comprehensive income (loss) | (2,738) | (2,751) | (2,751) | 13 | |||
Net loss | (336,318) | (335,202) | (335,202) | (1,116) | |||
Balance at the ending of period (in shares) at Jun. 30, 2020 | 1,014,976,692 | ||||||
Balance at the end of period at Jun. 30, 2020 | 2,546,492 | 2,536,298 | $ 102 | 5,200,275 | (9,299) | (2,654,780) | 10,194 |
Increase (Decrease) in Stockholders' Equity | |||||||
Issuance of ordinary shares in connection with collaboration | 2,069,610 | 2,069,610 | $ 14 | 2,069,596 | |||
Issuance of ordinary shares in connection with collaboration (in shares) | 145,838,979 | ||||||
Issuance of shares reserved for share option exercises | 1 | 1 | $ 1 | ||||
Issuance (use) of shares reserved for share option exercises and RSU releases (in shares) | 5,525,182 | ||||||
Exercise of options, ESPP and release of Restricted Share Units (RSUs) | 47,632 | 47,632 | $ 1 | 47,631 | |||
Exercise of options, ESPP and release of Restricted Share Units (RSUs) (in shares) | 16,575,806 | ||||||
Share-based compensation | 50,297 | 50,297 | 50,297 | ||||
Other comprehensive income (loss) | 9,099 | 8,880 | 8,880 | 219 | |||
Net loss | $ (426,617) | (425,224) | (425,224) | (1,393) | |||
Balance at the ending of period (in shares) at Sep. 30, 2020 | 1,182,916,659 | 1,182,916,659 | |||||
Balance at the end of period at Sep. 30, 2020 | $ 4,296,514 | $ 4,287,494 | $ 118 | $ 7,367,799 | $ (419) | $ (3,080,004) | $ 9,020 |
Description of Business, Basis
Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2020 | |
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”) is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. The Company started as a research and development company in Beijing in 2010. Over the last ten years, it has developed into a fully integrated global biotechnology company, with significant commercial, manufacturing, and research and development capabilities. The Company has built substantial commercial capabilities in China and the United States and is currently marketing both internally developed drugs and in-licensed drugs. In the United States, the Company markets BRUKINSA ® (zanubrutinib) for adult patients with mantle cell lymphoma ("MCL") who have received at least one prior therapy. In China, the Company markets BRUKINSA ® in two indications: for adult patients with chronic lymphocytic leukemia ("CLL") /small lymphocytic lymphoma ("SLL") who have received at least one prior therapy, and for adult patients with MCL who have received at least one prior therapy. In China, the Company also markets tislelizumab in two indications: for patients with classical Hodgkin’s Lymphoma ("cHL") who have received at least two prior therapies, and for patients with locally advanced or metastatic urothelial carcinoma ("UC"), a form of bladder cancer, with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The Company has filed additional new or supplementary new drug applications for regulatory approvals in China or elsewhere for its internally developed products and is planning to launch these additional products or indications in 2020 and beyond. The Company's commercial portfolio also includes the following drugs in-licensed from third parties: REVLIMID ® , VIDAZA ® and ABRAXANE ® , which the Company has been marketing in China since 2017 under a license from Celgene Logistics Sàrl, a Bristol Myers Squibb company (“BMS”); and XGEVA ® (denosumab), from Amgen Inc. ("Amgen"), which the Company began commercializing in July 2020. On March 25, 2020, the Company announced that the China National Medical Products Administration ("NMPA") suspended the importation, sales and use of ABRAXANE ® in China supplied to BeiGene by Celgene Corporation, a BMS company, and the drug was subsequently recalled by BMS and is not currently available for sale in China. The Company plans on launching additional in-licensed products once approved in China, including KYPROLIS ® (carfilzomib) and BLINCYTO ® (blinatumomab) from Amgen, and SYLVANT ® (siltuximab) and QARZIBA ® ▼ (dinutuximab beta) from EUSA Pharma ("EUSA"). Basis of presentation and consolidation The accompanying condensed consolidated balance sheet as of September 30, 2020, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2020 and 2019, the condensed consolidated statements of cash flows for the nine months ended September 30, 2020 and 2019, and the condensed consolidated statements of shareholders' equity for the three and nine months ended September 30, 2020 and 2019, 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, 2019 (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 the operations for the three and nine months ended September 30, 2020 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. Noncontrolling interests are recognized to reflect the portion of the equity of subsidiaries which are not attributable, directly or indirectly, to the controlling shareholders. The Company consolidates its interests in its joint venture, BeiGene Biologics Co., Ltd. ("BeiGene Biologics"), under the voting model and recognizes the minority shareholder's equity interest as a noncontrolling interest in its condensed consolidated financial statements. In September 2020, BeiGene (Hong Kong) Co., Limited ("BeiGene HK") entered into a share purchase agreement with the minority shareholder to acquire its equity interest in BeiGene Biologics. The share purchase is expected to be completed in the fourth quarter of 2020. Use of estimates The preparation of the unaudited interim condensed 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 the standalone selling price of each performance obligation in the Company’s revenue arrangements, estimating the fair value of net assets acquired in business combinations, assessing the impairment of long-lived assets, valuation and recognition of share-based compensation expenses, realizability of deferred tax assets, estimating uncertain tax positions, 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. Actual results could differ from these estimates. Recent accounting pronouncements New accounting standards which have been adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses . Subsequently, the FASB issued ASU 2019-05, Financial Instruments- Credit Losses (Topic 326): Targeted Transition Relief and ASU 2019-11 Codification Improvements to Topic 326, Financial Instruments- Credit Losses (collectively, the "Credit Loss ASUs"). The Credit Loss ASUs change the methodology to be used to measure credit losses for certain financial instruments and financial assets, including trade receivables. The new methodology requires the recognition of an allowance that reflects the current estimate of credit losses expected to be incurred over the life of the financial asset. This new standard also requires that credit losses related to available-for-sale debt securities be recorded as an allowance through net income rather than reducing the carrying amount under the current, other-than-temporary-impairment model. The Company adopted the standard on January 1, 2020. Based on the composition of the Company's trade receivables and investment portfolio, the adoption of this standard did not have a material impact on the Company’s financial position or results of operations upon adoption. The Company has updated its accounting policy for trade accounts receivable and is providing additional disclosure about its allowance for credit losses, as required by the standard, upon adoption. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurement . The update eliminates, modifies, and adds certain disclosure requirements for fair value measurements. The added disclosure requirements and the modified disclosure on the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented. All other changes to disclosure requirements in this update should be applied retrospectively to all periods presented upon their effective date. The Company adopted this standard on January 1, 2020. There was no material impact to the Company's financial position or results of operations upon adoption. In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract . This update requires a customer in a cloud computing arrangement that is a service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to defer and recognize as an asset. This guidance should be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. The Company adopted this standard on January 1, 2020. There was no material impact to the Company's financial position or results of operations upon adoption. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 . This update clarifies that certain transactions between participants in a collaborative arrangement should be accounted for under ASC 606 when the counterparty is a customer and precludes an entity from presenting consideration from a transaction in a collaborative arrangement as revenue from contracts with customers if the counterparty is not a customer for that transaction. This guidance should be applied retrospectively to the date of initial application of Topic 606. The Company adopted this standard on January 1, 2020. There was no material impact to the Company's financial position or results of operations upon adoption. New accounting standards which have not yet been adopted In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes . This update simplifies the accounting for income taxes as part of the FASB's overall initiative to reduce complexity in accounting standards. The amendments include removal of certain exceptions to the general principles of ASC 740, Income taxes , and simplification in several other areas such as accounting for a franchise tax (or similar tax) that is partially based on income. The update is effective in fiscal years beginning after December 15, 2020, and interim periods therein, and early adoption is permitted. Certain amendments in this update should be applied retrospectively or modified retrospectively, and all other amendments should be applied prospectively. The Company is currently evaluating the impact on its financial statements of adopting this guidance. 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, 2019. Accounts Receivable and Allowance for Credit Losses Trade accounts receivable are recorded at their invoiced amounts, net of trade discounts and allowances as well as an allowance for credit losses. The allowance for credit losses reflects the Company's current estimate of credit losses expected to be incurred over the life of the receivables. The Company considers various factors in establishing, monitoring, and adjusting its allowance for credit losses including the aging of receivables and aging trends, customer creditworthiness and specific exposures related to particular customers. The Company also monitors other risk factors and forward-looking information, such as country specific risks and economic factors that may affect a customer's ability to pay in establishing and adjusting its allowance for credit losses. Accounts receivable are written off after all collection efforts have ceased. Except for the changes to the Company’s significant accounting policies related to the adoption of the Credit Loss ASUs, there have been no other material changes to the Company’s significant accounting policies as of and for the nine months ended September 30, 2020, as compared to the significant accounting policies described in the Annual Report. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2020 | |
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 market with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the asset or liability. The Company considers an active market to be one in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis, and considers an inactive market to be one in which there are infrequent or few transactions for the asset or liability, the prices are not current, or price quotations vary substantially either over time or among market makers. The following tables present the Company’s financial assets and liabilities measured and recorded at fair value on a recurring basis using the above input categories as of September 30, 2020 and December 31, 2019: Quoted Price in Active Significant Market for Other Significant Identical Observable Unobservable Assets Inputs Inputs As of September 30, 2020 (Level 1) (Level 2) (Level 3) $ $ $ Short-term investments (Note 4): U.S. treasury securities 3,254,300 — — Cash equivalents: U.S. treasury securities 634,655 — — Money market funds 236,500 — — Other non-current assets: Equity securities (Note 4) 9,513 5,703 — Total 4,134,968 5,703 — Quoted Price in Active Significant Market for Other Significant Identical Observable Unobservable Assets Inputs Inputs As of December 31, 2019 (Level 1) (Level 2) (Level 3) $ $ $ Short-term investments (Note 4): U.S. treasury securities 364,728 — — Cash equivalents U.S. treasury securities 16,442 — — Money market funds 50,461 — — Total 431,631 — — The Company's equity securities 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. 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. |
Collaborative Arrangements
Collaborative Arrangements | 9 Months Ended |
Sep. 30, 2020 | |
Research and Development [Abstract] | |
Collaborative Arrangements | Collaborative Arrangements The Company enters into collaborative arrangements for the research and development, manufacture and/or commercialization of drug products and drug candidates. To date, these collaborative arrangements have included out-licenses of internally developed drug candidates to other parties, in-licenses of drug products and drug candidates from other parties, and profit and cost sharing arrangements. Amgen On October 31, 2019, the Company entered into a global strategic oncology collaboration with Amgen (the "Amgen Collaboration Agreement") for the commercialization and development in China, excluding Hong Kong, Taiwan and Macao, 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. On January 2, 2020, following approval by the Company's shareholders and satisfaction of other closing conditions, the agreement became effective. Under the agreement, the Company is responsible for the commercialization of XGEVA ® , KYPROLIS ® and BLINCYTO ® in China for five ® was approved in China in 2019 for patients with giant cell tumor of the bone and a supplemental new drug application has been filed for prevention of skeletal-related events in cancer patients with bone metastases. In July 2020, the Company began commercializing XGEVA ® in China. Additionally, new drug applications have been filed in China for KYPROLIS ® as a treatment for patients with multiple myeloma and BLINCYTO ® as a treatment for adult patients with relapsed or refractory acute lymphoblastic leukemia ("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 sotorasib (AMG 510), Amgen's investigational 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 sotorasib). 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 will recognize 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 on October 31, 2019. On January 2, 2020, the closing date of the transaction, Amgen purchased 15,895,001 of the Company's ADSs for $174.85 per ADS, representing a 20.5% ownership stake in the Company. Per the SPA, the cash proceeds shall be used as necessary to fund the Company's development obligations under the Amgen Collaboration Agreement. Pursuant to the SPA, Amgen also received the right to designate one member of the Company's board of directors, and Anthony Hooper joined the Company's board of directors as the Amgen designee in January 2020. In determining the fair value of the common stock at closing, the Company considered the closing price of the common stock on the closing date of the transaction and included a lack of marketability discount because the shares are subject to certain restrictions. The fair value of the shares on the closing date was determined to be $132.74 per ADS, or $2,109,902 in the aggregate. The Company determined that the premium paid by Amgen on the share purchase represents a cost share liability due to the Company's co-development obligations. The fair value of the cost share liability on the closing date was determined to be $601,857 based on the Company's discounted estimated future cash flows related to the pipeline assets. The total cash proceeds of $2,779,241 were allocated based on the relative fair value method, with $2,162,407 recorded to equity and $616,834 recorded as a research and development cost share liability. The cost share liability is being amortized proportionately as the Company contributes cash and development services to its total co-development funding cap. Amounts recorded related to the cash proceeds received from the Amgen collaboration for the nine months ended September 30, 2020 were as follows: Nine Months Ended September 30, 2020 $ Fair value of equity issued to Amgen 2,162,407 Fair value of research and development cost share liability 616,834 Total cash proceeds 2,779,241 Amounts recorded related to the Company's portion of the co-development funding on the pipeline assets for the three and nine months ended September 30, 2020 were as follows: Three Months Ended Nine Months Ended September 30, September 30, 2020 2020 $ $ Research and development expense 30,795 87,498 Amortization of research and development cost share liability 30,056 85,296 Total amount due to Amgen for BeiGene's portion of the development funding 60,851 172,794 Total amount of development funding paid or payable in cash 57,201 169,144 Total amount of development funding paid with development services 3,650 3,650 As of September 30, 2020 Remaining portion of development funding cap 1,077,206 At September 30, 2020, the research and development cost share liability recorded in the Company's balance sheet was as follows: As of September 30, 2020 $ Research and development cost share liability, current portion 147,387 Research and development cost share liability, non-current portion 384,151 Total research and development cost share liability 531,538 The total reimbursement due under the commercial profit-sharing agreement for in-line product sales is classified in the income statement for the three and nine months ended September 30, 2020 as follows: Three Months Ended Nine Months Ended September 30, September 30, 2020 2020 $ $ Cost of sales - product (1,023) (1,023) Research and development 61 61 Selling, general and administrative (3,667) (3,667) Total (4,629) (4,629) Celgene Corporation, a Bristol Myers Squibb company ("BMS") On July 5, 2017, the Company entered into a license agreement with Celgene Corporation, now a BMS company, pursuant to which the Company granted to the BMS parties an exclusive right to develop and commercialize the Company’s investigational PD-1 inhibitor, tislelizumab, in all fields of treatment, other than hematology, in the United States, Europe, Japan and the rest of world other than Asia (the “PD-1 License Agreement”). The Company entered into a mutual agreement with BMS to terminate the Amended and Restated PD-1 License Agreement effective June 14, 2019 in advance of the acquisition of Celgene by BMS. The following table summarizes total collaboration revenue recognized related to the BMS collaboration for the three and nine months ended September 30, 2020 and 2019: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ Reimbursement of research and development costs — — — 27,634 Research and development service revenue — — — 27,982 Other — — — 150,000 Total — — — 205,616 The Company recognized no collaboration revenue for the three and nine months ended September 30, 2020 and the three months ended September 30, 2019. For the nine months ended September 30, 2019, the Company recognized collaboration revenue of $205,616 related to its former collaboration with BMS. The Company recognized $27,634 of research and development reimbursement revenue for the nine months ended September 30, 2019 for the clinical trials that Celgene had opted into until the termination of the collaboration agreement. The $27,982 of research and development services revenue for the nine months ended September 30, 2019, primarily reflected the recognition of upfront consideration that was allocated to research and development services at the time of the collaboration and was recognized over the term of the respective clinical studies for the specified indications. The Company recognized $150,000 of other collaboration revenue for the nine months ended September 30, 2019 related to the payment received from Celgene in connection with the termination of the collaboration agreement. In-Licensing Arrangements The Company has in-licensed the rights to develop, manufacture and, if approved, commercialize multiple development stage drug candidates and drug products globally or in specific territories. These arrangements typically include non-refundable, upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost sharing arrangements, royalty payments, and profit sharing. Upfront and development milestones paid under these arrangements for the three and nine months ended September 30, 2020 and 2019 are set forth below. All upfront and development milestones were expensed to research and development expense. There have been no regulatory or commercial milestones paid under these arrangements to date. Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Research and development payments due to Collaboration Partners $ $ $ $ Upfront payments 66,500 — 109,500 30,000 Milestone payments 1,000 — 6,000 — Total 67,500 — 115,500 30,000 EUSA Pharma On January 13, 2020, the Company entered into an exclusive development and commercialization agreement with EUSA Pharma ("EUSA") for the orphan biologic products SYLVANT ® (siltuximab) and QARZIBA ® (dinutuximab beta) in China. Under the terms of the agreement, EUSA granted the Company exclusive rights to SYLVANT ® in greater China and to QARZIBA ® in mainland China. Under the agreement, the Company will fund and undertake all clinical development and regulatory submissions in the territories, and will commercialize both products once approved. EUSA received a $40,000 upfront payment and will be eligible to receive payments upon the achievement of regulatory and commercial milestones up to a total of $160,000. EUSA will also be eligible to receive tiered royalties on future product sales. The upfront payment was expensed to research and development expense during the nine months ended September 30, 2020 in accordance with the Company's acquired in-process research and development expense policy. Assembly Biosciences, Inc. On July 17, 2020, the Company entered into a collaboration agreement with Assembly Biosciences, Inc. ("Assembly") for Assembly's portfolio of three clinical-stage core inhibitor candidates for the treatment of patients with chronic hepatitis B virus ("HBV") infection in China. Under the terms of the agreement, Assembly granted BeiGene exclusive rights to develop and commercialize ABI-H0731, ABI-H2158 and ABI-H3733 in China, including Hong Kong, Macau, and Taiwan. BeiGene is responsible for development, regulatory submissions, and commercialization in China. Assembly retains full worldwide rights outside of the partnered territory for its HBV portfolio. Assembly received an upfront payment of $40,000 and is eligible to receive payments upon achievement of development, regulatory and commercial milestones up to a total of $503,750. Assembly is also eligible to receive tiered royalties on net sales. The upfront payment was expensed to research and development expense during the three and nine months ended September 30, 2020 in accordance with the Company's acquired in-process research and development expense policy. Bio-Thera Solutions, Ltd. On August 22, 2020, the Company entered into a license, distribution and supply agreement with Bio-Thera Solutions, Ltd. ("Bio-Thera") for Bio-Thera's BAT1706, an investigational biosimilar to Avastin® (bevacizumab) in China. The agreement became effective on September 10, 2020 upon approval of Bio-Thera's shareholders, and was subsequently assigned by the Company to its affiliate BeiGene (Guangzhou) Co., Ltd. ("BeiGene Guangzhou") on September 18, 2020, as permitted by the agreement. Under the terms of the agreement, Bio-Thera agreed to grant BeiGene the right to develop, manufacture, and commercialize BAT1706 in China, including Hong Kong, Macau, and Taiwan. Bio-Thera will retain rights outside of the partnered territory. Bio-Thera received an upfront payment of $20,000 in October 2020 and is eligible to receive payments upon the achievement of regulatory and commercial milestones up to a total of $145,000. Bio-Thera will also be eligible to receive tiered double digits royalties on future net product sales. The upfront payment was expensed to research and development expense during the three and nine months ended September 30, 2020 in accordance with the Company's acquired in-process research and development expense policy. Other In addition to the collaborations discussed above, the Company has entered into additional collaborative arrangements during the nine months ended September 30, 2020 and 2019. The Company may be required to pay additional amounts upon the achievement of various development, regulatory and commercial milestones under these agreements. The Company may also incur significant research and development costs if the related product candidates advance to late-stage clinical trials. In addition, if any products related to these collaborations are approved for sale, the Company may be required to pay milestones and royalties on future sales. The payment of these amounts, however, is contingent upon the occurrence of various future events, which have a high degree of uncertainty of occurrence. |
Restricted Cash and Investments
Restricted Cash and Investments | 9 Months Ended |
Sep. 30, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Restricted Cash and Investments | Restricted Cash and Investments Restricted Cash The Company’s restricted cash balance of $5,245 as of September 30, 2020 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. Short-Term Investments Short-term investments as of September 30, 2020 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 3,252,873 1,427 — 3,254,300 Total 3,252,873 1,427 — 3,254,300 Short-term investments as of December 31, 2019 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 363,440 1,288 — 364,728 Total 363,440 1,288 — 364,728 As of September 30, 2020, the Company's available-for-sale debt securities consisted entirely of short-term U.S. treasury securities, which were determined to have zero risk of expected credit loss. Accordingly, no allowance for credit loss was recorded as of September 30, 2020. Equity Method Investments 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. As of September 30, 2020, the Company's ownership interest in the outstanding common stock of Leap was 8.1% 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 14.9% based on information from Leap. The Company determined that the investment in Leap represents an equity method investment upon conversion due to the existing collaboration between the two parties. The Company elected to apply the fair value option to the equity method investment and measure the investment in the common stock and warrants at fair value, with changes in fair value recorded to other income. The fair value of the common stock and warrants was $9,513 and $5,703, respectively, as of September 30, 2020. During the three and nine months ended September 30, 2020, the Company recorded an unrealized (loss)/gain of $(1,048) and $10,216, respectively, in the statement of operations, respectively. MapKure, LLC In June 2019, the Company announced the formation of MapKure, LLC ("MapKure"), an entity jointly owned by the Company and SpringWorks Therapeutics, Inc. ("SpringWorks"). The Company out-licensed to MapKure the Company's product candidate BGB-3245, an oral, selective small molecule inhibitor of monomer and dimer forms of activating B-RAF mutations including V600 BRAF mutations, non-V600 B-RAF mutations, and RAF fusions. The Company received 10,000,000 Series A preferred units of MapKure, or a 71.4% ownership interest in exchange for its contribution of the intellectual property. SpringWorks purchased 3,500,000 Series A preferred units, or a 25% ownership interest, and other investors purchased 250,000 Series A preferred units or 1.8% ownership each. Following the initial closing, the Company consolidated its interests in MapKure under the voting model due to its controlling financial interest. On June 8, 2020, MapKure held a second closing under the existing terms of the SPA in which it issued additional Series A preferred units to SpringWorks and the other investors that purchased units in the first closing (the "Second Closing"), and the Company's ownership interest decreased to 55.6%. As the requisite Series A voting requirements in MapKure's governing documents require 70% combined voting power for certain actions, the Company determined that it lost its controlling financial interest after the Second Closing. Therefore, the Company deconsolidated MapKure and recognized a gain of $11,307 for the excess of the fair value of its 55.6% ownership interest in MapKure and carrying amount of the prior non-controlling interest over the carrying amount of MapKure's net assets within other income during the three and nine months ended September 30, 2020. Upon deconsolidation, the Company recorded an equity investment of $10,000, which represents the estimated fair value of its 55.6% ownership interest in MapKure. Effective June 8, 2020, the Company is accounting for the investment as an equity-method investment and records its portion of MapKure's earnings or losses within other income (expense), net. The Company recognized losses of $143 and $166 for its portion of MapKure's net loss for the three and nine months ended September 30, 2020, respectively. As of September 30, 2020, the carrying amount of the Company's investment in MapKure was $9,834. Guangzhou GET Phase I Biomedical Industry Investment Fund Partnership (Limited Partnership) On July 23, 2020, BeiGene (Guangzhou) invested $11,782 (RMB80,000) in an existing investment fund, Guangzhou GET Phase I Biomedical Industry Investment Fund Partnership (Limited Partnership) (“GET Bio-fund”). The stated purpose of GET two |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories The Company’s inventory balance consisted of the following: As of September 30, December 31, 2020 2019 $ $ Raw materials 1,235 — Work in process — — Finished goods 34,290 28,553 Total inventories 35,525 28,553 |
Property, plant and equipment
Property, plant and equipment | 9 Months Ended |
Sep. 30, 2020 | |
Property, Plant and Equipment [Abstract] | |
Property, plant and equipment | Property, plant and equipment Property, plant and equipment are recorded at cost and consisted of the following: As of September 30, December 31, 2020 2019 $ $ Laboratory equipment 62,402 47,154 Leasehold improvements 29,225 24,008 Building 111,813 109,514 Manufacturing equipment 70,081 62,775 Software, electronics and office equipment 18,569 14,705 Property, plant and equipment, at cost 292,090 258,156 Less accumulated depreciation (61,443) (36,709) Construction in progress 60,571 20,955 Property, plant and equipment, net 291,218 242,402 As of September 30, 2020 and December 31, 2019, construction in progress ("CIP") of $60,571 and $20,955, respectively, was primarily related to the buildout of additional capacity at the Guangzhou manufacturing facility. Subsequent phases of the Guangzhou factory buildout will continue to be recorded as CIP until they are placed into service. Depreciation expense for the three and nine months ended September 30, 2020 was $8,157 and $23,303, respectively. Depreciation expense for the three and nine months ended September 30, 2019 was $3,691 and $10,139, respectively. |
Guangzhou Biologics Business
Guangzhou Biologics Business | 9 Months Ended |
Sep. 30, 2020 | |
Equity Method Investments and Joint Ventures [Abstract] | |
Guangzhou Biologics Business | Guangzhou Biologics Business Manufacturing legal entity structure BeiGene (Shanghai) Co., Ltd. ("BeiGene Shanghai"), originally established as a wholly-owned subsidiary of BeiGene HK, and currently a wholly-owned subsidiary of BeiGene Biologics, as described below, provides clinical development services for BeiGene affiliates and is the clinical trial authorization ("CTA") holder and marketing authorization application ("MAA") holder for tislelizumab in China. In March 2017, BeiGene HK, a wholly-owned subsidiary of the Company, and Guangzhou GET Technology Development Co., Ltd. (now Guangzhou High-tech Zone Technology Holding Group Co., Ltd.) (“GET”) entered into a definitive agreement to establish a commercial-scale biologics manufacturing facility in Guangzhou, Guangdong Province, PRC. In March 2017, BeiGene HK and GET entered into an Equity Joint Venture Contract (the “JV Agreement”). Under the terms of the JV Agreement, BeiGene HK made an initial cash capital contribution of RMB200,000 and a subsequent contribution of one or more biologics assets in exchange for a 95% equity interest in BeiGene Biologics. GET made a cash capital contribution of RMB100,000 to BeiGene Biologics, representing a 5% equity interest in BeiGene Biologics. In addition, on March 7, 2017, BeiGene Biologics entered into a contract with GET, under which GET agreed to provide a RMB900,000 loan (the “Shareholder Loan”) to BeiGene Biologics (see Note 11). In September 2019, BeiGene Biologics completed the first phase of construction of a biologics manufacturing facility in Guangzhou, through a wholly-owned subsidiary, BeiGene Guangzhou Biologics Manufacturing Co., Ltd. ("BeiGene Guangzhou Factory"), to manufacture biologics for the Company and its subsidiaries. In April 2017, BeiGene HK, GET and BeiGene Biologics amended the JV Agreement and the capital contribution agreement, among other things, to adjust the capital contribution schedules and adjust the initial term of the governing bodies and a certain management position. In the second quarter of 2017, BeiGene HK made cash capital contributions of RMB137,830 and RMB2,415, respectively, into BeiGene Biologics. The remainder of the cash capital contribution from BeiGene HK to BeiGene Biologics was paid in June 2019. In April 2017, GET made cash capital contributions of RMB100,000 into BeiGene Biologics, and BeiGene Biologics drew down the Shareholder Loan of RMB900,000 from GET (see Note 11). In the fourth quarter of 2017, BeiGene HK and BeiGene Biologics entered into an Equity Transfer Agreement to transfer 100% of the equity interest of BeiGene Shanghai to BeiGene Biologics, as required by the JV Agreement, such that the CTA holder and MAA holder for tislelizumab in China was controlled by BeiGene Biologics. The transfer consideration for the purchased interests under this Equity Transfer Agreement is the fair value of the 100% equity of BeiGene Shanghai appraised by a qualified Chinese valuation firm under the laws of the PRC. Upon the transfer of equity in BeiGene Shanghai, BeiGene HK’s equity interest in BeiGene Shanghai became 95%. As of September 30, 2020, the Company and GET held 95% and 5% equity interests in BeiGene Biologics, respectively. On September 28, 2020, BeiGene HK entered into a share purchase agreement (“JV Share Purchase Agreement”) with GET to acquire GET’s 5% equity interest in BeiGene Biologics for a total purchase price of $28,723 (RMB195,262). In conjunction with the JV Share Purchase Agreement, BeiGene Biologics repaid the outstanding principal of the shareholder loan of $132,061 (RMB900,000) and accrued interest of $36,558 (RMB249,140) (see Note 11). BeiGene HK paid the purchase price of GET's 5% equity interest to Guangdong United Assets and Equity Exchange (“the GD Exchange”), and recorded the payment as a long-term prepaid expense as of September 30, 2020, as the finalization of the transaction is pending completion of the business registration filing. The Company expects this to occur in the fourth quarter of 2020. In connection with the JV share purchase, 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 will be used to fund the JV share repurchase and repayment of the shareholder loan and $80,000 can be used for general working capital purposes. The loan has an original maturity date of 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 twelve month periods. The Company did not draw down any amount of the Senior Loan as of September 30, 2020. On October 9, 2020, the Company drew down $80,000 of the working capital facility and $118,320 of the acquisition facility to be used for the JV share repurchase. In addition, the Company entered into a loan agreement with Zhuhai Hillhouse Zhaohui Equity Investment Partnership ("Zhuhai Hillhouse") for a total loan facility of $73,640 (RMB500,000) ("Junior Loan"), of which $14,728 (RMB100,000) can be used for general corporate purposes and $58,912 (RMB400,000) can only be applied towards the repayment of the Senior Loan facility, including principal, interest and fees. The Company has drawn down $14,728 (RMB100,000) of the Junior Loan as of September 30, 2020. See Note 11 for further discussion of the loans. Commercial distribution legal entity structure BeiGene (Guangzhou), a wholly-owned subsidiary of BeiGene HK, was organized on July 11, 2017. In September 2018, BeiGene (Guangzhou) acquired 100% of the equity interests of Baiji Shenzhou (Guangzhou) Pharmaceuticals Co., Ltd. (formerly known as Huajian Pharmaceuticals Co., Ltd.), which subsequently changed its name to BeiGene Pharmaceuticals (Guangzhou) Co., Ltd. (“BPG”). BPG owns drug distribution licenses necessary to distribute pharmaceutical products in China. The Company acquired these drug distribution licenses through the acquisition of BPG, which was accounted for as an asset acquisition, as it is difficult to obtain a newly issued domestic drug distribution license in China. Commercial supply agreement and facility expansion In January 2018, the Company entered into a commercial supply agreement with Boehringer Ingelheim Biopharmaceuticals (China) Ltd. (“Boehringer Ingelheim”) for tislelizumab, which is being manufactured at Boehringer Ingelheim’s facility in Shanghai, China as part of a Marketing Authorization Holder (“MAH”) project pioneered by the Company and Boehringer Ingelheim. Under the terms of the commercial supply agreement, Boehringer Ingelheim has agreed to manufacture tislelizumab in China under an exclusive multi-year arrangement, with contract extension possible. In addition, the Company obtained certain preferred rights for future capacity expansion by Boehringer Ingelheim in China. In October 2018, the Company entered into a binding letter of intent ("LOI") with Boehringer Ingelheim to increase the amount of tislelizumab supplied under the agreement through the expansion of Boehringer Ingelheim's facility to add a second bioreactor production line. Under the terms of the binding LOI, the Company provided initial funding for the facility expansion and may make additional payments for contingency costs. This initial funding payment and any subsequent contingency payments will be credited against future purchases of tislelizumab over the term of the supply agreement. The payment was recorded as a noncurrent asset since it is considered a long-term prepayment for future product costs that will provide future benefit to the Company through credits on purchases of tislelizumab from Boehringer Ingelheim over the life of the supply agreement. |
Intangible Assets
Intangible Assets | 9 Months Ended |
Sep. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible Assets Intangible assets as of September 30, 2020 and December 31, 2019 are summarized as follows: As of September 30, 2020 December 31, 2019 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 (2,312) 5,188 7,500 (1,750) 5,750 Trading license 816 (816) — 816 (720) 96 Total finite-lived intangible assets 8,316 (3,128) 5,188 8,316 (2,470) 5,846 Product distribution rights consist of distribution rights on the approved cancer therapies licensed from BMS, REVLIMID ® , VIDAZA ® , and ABRAXANE ® , acquired as part of the BMS transaction in 2017. The Company is amortizing the product distribution rights over a period of 10 years which is the term of the agreement. The trading license represents the Guangzhou drug distribution license acquired on September 21, 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 of intangible assets for the three and nine months ended September 30, 2020 was $187 and $658, respectively. Amortization expense of intangible assets for the three and nine months ended September 30, 2019 was $331 and $994, respectively. As of September 30, 2020, expected amortization expense for the unamortized finite-lived intangible assets is approximately $188 for the remainder of 2020, $750 in 2021, $750 in 2022, $750 in 2023, $750 in 2024, and $2,000 in 2025 and thereafter. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Income tax benefit was $8,423 and $8,344 for the three and nine months ended September 30, 2020, respectively, and $3,217 and $569 for the three and nine months ended September 30, 2019, respectively. The income tax benefit for the three and nine months ended September 30, 2020 was primarily attributable to the tax benefit of U.S. stock-based compensation deductions, in excess of tax expense on income reported in certain China subsidiaries as adjusted for certain non-deductible expenses. The income tax benefit for the three and nine months ended September 30, 2019 was primarily attributable to research and development tax credits, the tax benefit of deferred U.S. stock based compensation deductions, valuation allowance release and special tax deductions and incentives in the U.S and China. In response to the COVID-19 pandemic, the Coronavirus Aid, Relief and Economic Security Act (CARES Act) was signed into law on March 27, 2020. The CARES Act removes certain net operating loss deduction and carry-back limitations originally imposed by the Tax Cuts and Jobs Act of 2017. Specifically, the Company may now carry back net operating losses (“NOLs”) originating in 2018 and 2019 to 2017 and 2016, resulting in an income tax receivable of $5,586 as of September 30, 2020. The enactment of the CARES Act did not have a material effect on our income tax expense. 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, the Company believes that as of September 30, 2020, it is more likely than not that deferred tax assets will not be realized for the Company’s subsidiaries in Australia and Switzerland, for certain subsidiaries in China, and for all U.S. tax credit carry-forwards. As of September 30, 2020, the Company had gross unrecognized tax benefits of $6,542. 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 $759 and $1,909, respectively, in the three and nine months ended September 30, 2020 primarily due to U.S. federal and state tax credits and incentives. The Company has elected to record interest and penalties related to income taxes as a component of income tax expense. As of September 30, 2020 and December 31, 2019, the Company's accrued interest and penalties, where applicable, related to uncertain tax positions were not material. The Company conducts business in a number of tax jurisdictions and, as such, is required to file income tax returns in multiple jurisdictions globally. As of September 30, 2020, Australia tax matters are open to examination for the years 2013 through 2020, China tax matters are open to examination for the years 2014 through 2020, Switzerland tax matters are open to examination for the years 2017 through 2020, and U.S. federal tax matters are open to examination for years 2015 through 2020. Various U.S. states and other non-US tax jurisdictions in which the Company files tax returns remain open to examination for 2010 through 2020. |
Supplemental Balance Sheet Info
Supplemental Balance Sheet Information | 9 Months Ended |
Sep. 30, 2020 | |
Balance Sheet Related Disclosures [Abstract] | |
Supplemental Balance Sheet Information | Supplemental Balance Sheet Information The roll-forward of the allowance for credit losses related to trade accounts receivable for the nine months ended September 30, 2020 consists of the following activity: Allowance for Credit Losses $ Balance as of December 31, 2019 — Current period provision for expected credit losses 114 Amounts written-off — Recoveries of amounts previously written-off — Balance as of September 30, 2020 114 Prepaid expenses and other current assets consist of the following: As of September 30, December 31, 2020 2019 $ $ Prepaid research and development costs 76,498 65,886 Prepaid taxes 14,192 9,498 Payroll tax receivables 13,537 5,365 Interest receivable 5,792 1,932 Prepaid insurance 3,775 711 Prepaid manufacturing costs 22,136 3,829 Income tax receivable 8,062 — Other 6,888 3,017 Total 150,880 90,238 Other non-current assets consist of the following: As of September 30, December 31, 2020 2019 $ $ Goodwill 109 109 Prepayment of property and equipment 32,931 10,289 Prepayment of facility capacity expansion activities (1) 30,366 24,881 Prepaid VAT 29,413 29,967 Prepayment for JV share repurchase 28,723 — Rental deposits and other 4,302 3,209 Equity method investments (Note 4) 36,756 — Total 162,600 68,455 (1) Represents payments for facility expansions under commercial supply agreements. The payments will provide future benefit to the Company through credits on future supply purchases. Accrued expenses and other payables consist of the following: As of September 30, December 31, 2020 2019 $ $ Compensation related 71,255 54,156 External research and development related 139,990 62,794 Commercial activities 40,179 25,645 Income tax and other taxes 19,815 9,648 Sales rebates and returns related 7,524 3,198 Professional fees and other 560 8,115 Total 279,323 163,556 Other long-term liabilities consist of the following: As of September 30, December 31, 2020 2019 $ $ Deferred government grant income 47,720 46,391 Other 170 171 Total 47,890 46,562 |
Debt
Debt | 9 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
Debt | Debt Bank Loans On April 4, 2018, BeiGene Guangzhou Factory entered into a nine-year loan agreement with China Construction Bank to borrow an RMB denominated loan of RMB580,000 at a floating interest rate benchmarked against prevailing interest rates of certain PRC financial institutions. The loan is secured by BeiGene Guangzhou Factory’s land use right and certain Guangzhou Factory fixed assets of the first phase of the Guangzhou manufacturing facility build out with a total carrying amount of $142,121. Interest expense is paid quarterly until the loan is fully settled. As of September 30, 2020, the Company has fully drawn down $85,422 (RMB580,000) of the loan. The loan interest rate was 4.9% for the nine months ended September 30, 2020, and the maturity dates range from 2021 to 2027. On January 13, 2020, BeiGene (Shanghai) Co., Ltd. entered into a one-year loan agreement with China Industrial Bank to borrow up to RMB200,000 at a fixed interest rate of 5.6%. During the nine months ended September 30, 2020, the Company drew down $20,148 (RMB140,000) of the loan. Interest will be paid quarterly until the loan is fully settled. As of September 30, 2020, the amount outstanding under the loan agreement was $20,619 (RMB140,000). On January 22, 2020, 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 will be secured by Guangzhou Factory's second land use right and fixed assets that will be placed into service upon completion of the second phase of the Guangzhou manufacturing facility build out. Interest is paid quarterly until the loan is fully settled. On April 30, 2020, the Company drew down $49,560 (RMB350,000). As of September 30, 2020, the amount outstanding under the loan agreements was $51,548 (RMB350,000). The loan interest rate was 4.4% for the nine months ended September 30, 2020, and the maturity dates range from 2022 to 2029. On May 21, 2020, BeiGene (Beijing) Co., Ltd. entered into a one-year loan agreement with China Merchants Bank to borrow up to RMB100,000. During the nine months ended September 30, 2020, the Company drew down the full amount of the loan of $14,223 (RMB100,000) at an average interest rate of 4.5%. Interest will be paid quarterly until the loan is fully settled. As of September 30, 2020 the amount outstanding under the loan agreement was $14,728 (RMB100,000). On June 11, 2020, BeiGene (Beijing) Co., Ltd. entered into a one-year loan agreement with China Industrial Bank to borrow up to $26,510 (RMB180,000) for general working capital purposes. The loan is secured by our research and development facility in Beijing and the associated land use right owned by our subsidiary Beijing Innerway Bio-tech Co., Ltd. On September 8, 2020, the Company drew down $14,612 (RMB100,000) of the loan at a fixed interest rate of 4.4%. Interest will be paid quarterly until the loan is fully settled. As of September 30, 2020 the amount outstanding under the loan agreement was $14,728 (RMB100,000). On September 24, 2020, BeiGene, Ltd. 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 will be used to fund the JV share purchase and repayment of the shareholder loan and $80,000 can be used for general working capital purposes. The loan has an original maturity date of 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 twelve month periods. The Company did not draw down any amount of the senior loan as of September 30, 2020. On October 9, 2020, the Company drew down $80,000 of the working capital facility and $118,320 of the acquisition facility to be used for the JV share repurchase. Related party loan On September 24, 2020, BeiGene Biologics entered into a loan agreement with Zhuhai Hillhouse for a total loan facility of $73,640 (RMB500,000), of which $14,728 (RMB100,000) can be used for general corporate purposes and $58,912 (RMB400,000) can only be applied towards repayment of the Senior Loan, including principal, interest and fees. The loan matures at the earliest of approximately 37 months from the date of draw down, one month after the final Senior Loan maturity date, or 10 business days after the Senior Loan is fully repaid. The Company drew down the first tranche of $14,728 (RMB100,000) on September 30, 2020 at an interest rate of 5.8%. Interest will be paid quarterly until the loan is fully settled. Zhuhai Hillhouse is a related party of the Company, as it is an affiliate of Hillhouse Capital. Hillhouse Capital is a shareholder of the Company, and a Hillhouse Capital employee is a member of the Company's board of directors. Interest on bank and related party loans Interest expense recognized for the three and nine months ended September 30, 2020 was $1,621 and $5,228, respectively, of which $97 and $214, respectively, was capitalized. Interest expense recognized for the three and nine months ended September 30, 2019 was $1,287 and $3,395, respectively, of which $875 and $2,254, respectively, was capitalized. Shareholder Loan On March 7, 2017, BeiGene Biologics entered into a Shareholder Loan Contract with GET, pursuant to which GET agreed to provide a shareholder loan of RMB900,000 to BeiGene Biologics (the "Shareholder Loan"). The Shareholder Loan included a conversion feature, which allowed the loan to be settled in a variable number of shares of common stock upon conversion (the “debt-to-equity conversion”). On April 14, 2017, BeiGene Biologics drew down the entire Shareholder Loan of RMB900,000 from GET. The Shareholder Loan was classified as a long-term liability and initially measured at the principal of RMB900,000. Interest accrued based on the interest rate of 8% per annum. The portion of interest accrued on the Shareholder Loan related to borrowings used to construct the BeiGene factory in Guangzhou was capitalized in accordance with ASC 835-20, Interest – Capitalization of Interest. On September 28, 2020, BeiGene HK entered into the JV Share Purchase Agreement with GET to acquire GET’s 5% equity interest in BeiGene Biologics (see Note 7). In connection with the JV Share Purchase Agreement, BeiGene Biologics repaid the outstanding principal amount of the Shareholder Loan of $132,061 (RMB900,000) and accrued interest of $36,558 (RMB249,140) on September 28, 2020. For the three and nine months ended September 30, 2020, total interest generated from the Shareholder Loan through the date of repayment was $2,518 and $7,621, respectively, of which, nil and nil was capitalized, respectively. For the three and nine months ended September 30, 2019, total interest expense generated from the Shareholder Loan was $2,671 and $7,847, respectively, of which, $958 and $2,462, respectively, was capitalized. |
Product Revenue
Product Revenue | 9 Months Ended |
Sep. 30, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Product Revenue | Product Revenue The Company’s product revenue is derived from the sale of its internally developed products BRUKINSA ® in the United States and China and tislelizumab in China, as well as the sale of REVLIMID ® , VIDAZA ® and ABRAXANE ® in China under a license from BMS and XGEVA ® in China under a license from Amgen. On March 25, 2020, the Company announced that the NMPA suspended the importation, sales and use of ABRAXANE ® in China supplied to BeiGene by Celgene Corporation, a BMS company, and the drug was subsequently recalled by BMS and is not currently available for sale in China. The table below presents the Company’s net product sales for the three and nine months ended September 30, 2020 and 2019. Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ Product revenue – gross 95,333 52,461 216,210 169,730 Less: Rebates and sales returns (4,253) (2,320) (7,436) (4,026) Product revenue – net 91,080 50,141 208,774 165,704 The following table disaggregates net product sales by product for the three and nine months ended September 30, 2020 and September 30, 2019: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ Tislelizumab 49,934 — 99,877 — BRUKINSA® 15,662 — 23,353 — REVLIMID® 14,067 19,019 38,914 58,976 VIDAZA® 8,366 8,624 26,198 22,365 ABRAXANE® — 22,498 17,381 84,363 XGEVA® 3,051 — 3,051 — Total product revenue – net 91,080 50,141 208,774 165,704 The following table presents the roll-forward of accrued sales rebates and returns for the nine months ended September 30, 2020 and September 30, 2019: Sales Rebates $ Balance as of December 31, 2018 4,749 Accrual 4,026 Payments (5,013) Balance as of September 30, 2019 3,762 Balance as of December 31, 2019 3,198 Accrual 7,436 Payments (3,110) Balance as of September 30, 2020 7,524 |
Loss Per Share
Loss Per Share | 9 Months Ended |
Sep. 30, 2020 | |
Earnings Per Share [Abstract] | |
Loss Per Share | Loss Per Share Loss per share was calculated as follows: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ Numerator: Net loss attributable to BeiGene, Ltd. (425,224) (307,357) (1,124,161) (560,567) Denominator: Weighted average shares outstanding, basic and diluted 1,148,973,077 781,482,459 1,052,940,583 777,938,599 Net loss per share attributable to BeiGene, Ltd., basic and diluted (0.37) (0.39) (1.07) (0.72) The effects of all share options, restricted shares and restricted share units were excluded from the calculation of diluted loss per share, as their effect would have been anti-dilutive during the three and nine months ended September 30, 2020 and 2019. |
Share-Based Compensation Expens
Share-Based Compensation Expense | 9 Months Ended |
Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Compensation Expense | Share-Based Compensation Expense 2016 Share Option and Incentive Plan On January 14, 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 on February 2, 2016. The Company initially reserved 65,029,595 ordinary shares for the issuance of awards under the 2016 Plan, plus any shares available under the 2011 Option Plan (the “2011 Plan”), and not subject to any outstanding options as of the effective date of the 2016 Plan, along with underlying share awards under the 2011 Plan that are cancelled or forfeited without issuance of ordinary shares. As of September 30, 2020, ordinary shares cancelled or forfeited under the 2011 Plan that were carried over to the 2016 Plan totaled 5,159,906. The 2016 Plan formerly provided for an annual increase in the shares available for issuance, to be added on the first day of each fiscal year, beginning on January 1, 2017, equal to the lesser of (i) five percent (5%) of the outstanding shares of the Company’s ordinary shares on the last day of the immediately preceding fiscal year or (ii) such number of shares determined by the Company’s board of directors or the compensation committee. In August 2018, in connection with the Company's IPO on The Stock Exchange of Hong Kong Limited ("HKEx"), the board of directors of the Company approved an amended and restated 2016 Plan to remove this “evergreen” provision and implement other changes required by the listing rules of the HKEx. In December 2018, the shareholders approved a second amended and restated 2016 Plan to increase the number of shares authorized for issuance by 38,553,159 ordinary shares, as well as amend the cap on annual compensation to independent directors and make other changes. In June 2020, the shareholders approved an Amendment No. 1 to the 2016 Plan to increase the number of shares authorized for issuance by 57,200,000 ordinary shares and to extend the term of the plan through April 13, 2030. The number of shares available for issuance under the 2016 Plan is subject to adjustment in the event of a share split, share dividend or other change in the Company’s capitalization. During the nine months ended September 30, 2020, the Company granted options for 8,747,440 ordinary shares and restricted share units for 17,185,597 ordinary shares under the 2016 Plan. As of September 30, 2020, options and restricted share units for ordinary shares outstanding under the 2016 Plan totaled 75,861,996 and 33,743,359, respectively. 2018 Inducement Equity Plan On June 6, 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 HKEx. During the nine months ended September 30, 2020, the Company did not grant any options or restricted share units under the 2018 Plan. As of September 30, 2020, options and restricted share units for ordinary shares outstanding under the 2018 Plan totaled 39,910 and 1,706,692, respectively. 2018 Employee Share Purchase Plan On June 6, 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 August 2018, in connection with the Hong Kong IPO, the board of directors of the Company approved an amended and restated ESPP to remove an “evergreen” share replenishment provision originally included in the plan and implement other changes required by the listing rules of the HKEx. In December 2018, the shareholders of the Company approved a second 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. 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. On August 31, 2020, the Company issued 485,069 ordinary shares to employees for aggregate proceeds of $5,203 under the ESPP. The purchase price of the shares was $139.45 per ADS, or $10.73 per ordinary share, which was discounted in accordance with the terms of the ESPP from the closing price o NASDAQ on March 2, 2020 of $164.06 per ADS, or $12.62 per ordinary share. On February 28, 2020, the Company issued 425,425 ordinary shares to employees for aggregate proceeds of $4,048 under the ESPP. The purchase price of the shares was $123.71 per ADS, or $9.52 per ordinary share, which was discounted in accordance with the terms of the ESPP from the closing price on NASDAQ on September 3, 2019 of $145.54 per ADS, or $11.20 per ordinary share. On August 30, 2019, the Company issued 233,194 ordinary shares to employees for aggregate proceeds of $2,192 under the ESPP. The purchase price of the shares was $122.19 per ADS, or $9.40 per ordinary share, which was discounted in accordance with the terms of the ESPP from the closing price on NASDAQ on August 30, 2019 of $143.75 per ADS, or $11.06 per ordinary share. On February 28, 2019, the Company issued 154,505 ordinary shares to employees for aggregate proceeds of $1,385 under the ESPP. The purchase price of the shares was $116.49 per ADS, or $8.96 per ordinary share, which was discounted in accordance with the terms of the ESPP from the closing price on NASDAQ on February 28, 2019 of $137.05 per ADS, or $10.54 per ordinary share. The following table summarizes total share-based compensation expense recognized for the three and nine months ended September 30, 2020 and 2019: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ Research and development 25,410 20,674 69,521 54,599 Selling, general and administrative 24,887 16,144 64,499 41,213 Total 50,297 36,818 134,020 95,812 |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Accumulated Other Comprehensive Income | Accumulated Other Comprehensive Income The movement of accumulated other comprehensive income was as follows: Unrealized Foreign Currency Gains on Translation Available-for-Sale Adjustments Securities Total $ $ $ Balance as of December 31, 2019 (9,291) 1,290 (8,001) Other comprehensive income before reclassifications 7,398 1,734 9,132 Amounts reclassified from accumulated other comprehensive income — (1,550) (1,550) Net-current period other comprehensive income 7,398 184 7,582 Balance as of September 30, 2020 (1,893) 1,474 (419) |
Shareholders_ Equity
Shareholders’ Equity | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Shareholders’ Equity | Shareholders’ Equity Registered Direct Offering On July 15, 2020, the Company issued 145,838,979 ordinary shares, par value $0.0001, to eight existing investors including entities associated with Hillhouse Capital and Baker Bros. Advisors LP, as well as Amgen, in a registered direct offering under the Company's effective Registration Statement on Form S-3 (File No. 333-238181). Each ordinary share was sold for a purchase price of $14.2308 per share ($185.00 per ADS), resulting in gross proceeds of approximately $2,075,000, and net proceeds, after offering expenses, of approximately $2,069,610. The shares were priced on July 12, 2020, and the last reported sale price of the ADSs on the NASDAQ on July 10, 2020 was $196.03 per ADS. The offering was made without an underwriter or a placement agent, and as a result the Company did not pay any underwriting discounts or commissions in connection with the offering. Share Purchase Agreement On January 2, 2020, the Company sold 15,895,001 ADSs, representing a 20.5% ownership stake in the Company, to Amgen for aggregate cash proceeds of $2,779,241, or $174.85 per ADS, pursuant to the SPA executed in connection with the Amgen Collaboration Agreement. |
Restricted Net Assets
Restricted Net Assets | 9 Months Ended |
Sep. 30, 2020 | |
Restricted Net Assets Disclosure [Abstract] | |
Restricted Net Assets | Restricted Net Assets The Company’s ability to pay dividends may depend on the Company receiving distributions of funds from its PRC subsidiaries. Relevant PRC statutory laws and regulations permit payments of dividends by the Company’s PRC subsidiaries only out of the subsidiary's retained earnings, if any, as determined in accordance with PRC accounting standards and regulations. The results of operations reflected in the condensed consolidated financial statements prepared in accordance with GAAP differ from those reflected in the statutory financial statements of the Company’s PRC subsidiaries. In accordance with the company law of the PRC, a domestic enterprise is required to provide statutory reserves of at least 10% of its annual after-tax profit until such reserve has reached 50% of its respective registered capital based on the enterprise’s PRC statutory accounts. A domestic enterprise is also required to provide discretionary surplus reserve, at the discretion of the board of directors, from the profits determined in accordance with the enterprise’s PRC statutory accounts. The aforementioned reserves can only be used for specific purposes and are not distributable as cash dividends. The Company’s PRC subsidiaries were established as domestic enterprises and therefore are subject to the above-mentioned restrictions on distributable profits. As a result of these PRC laws and regulations, including the requirement to make annual appropriations of at least 10% of after-tax income and set aside as general reserve fund prior to payment of dividends, the Company’s PRC subsidiaries are restricted in their ability to transfer a portion of their net assets to the Company. Foreign exchange and other regulations in the PRC may further restrict the Company's PRC subsidiaries from transferring funds to the Company in the form of dividends, loans and advances. As of September 30, 2020 and December 31, 2019, amounts restricted were the net assets of the Company’s PRC subsidiaries, which amounted to $158,737 and $109,633, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Purchase Commitments As of September 30, 2020, the Company had purchase commitments amounting to $142,858, of which $103,207 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $39,651 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 $63,125 for the acquisition of property, plant and equipment as of September 30, 2020, which were mainly for BeiGene Guangzhou Factory’s manufacturing facility in Guangzhou, China. Co-development funding commitment Under the Amgen Collaboration Agreement, the Company is responsible for co-funding global development costs for the Amgen oncology pipeline assets up to a total cap of $1,250,000. The Company is funding its portion of the co-development costs by contributing cash and development services. As of September 30, 2020, the Company's remaining co-development funding commitment was $1,077,206. Other Business Agreements The Company enters into agreements in the ordinary course of business with contract research organizations ("CROs") to provide research and development services. These contracts are generally cancelable 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. |
Segment and geographic informat
Segment and geographic information | 9 Months Ended |
Sep. 30, 2020 | |
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 substantially located in the PRC. Net product revenues by geographic area are based upon the location of the customer, and net collaboration revenue is recorded in the jurisdiction in which the related income is expected to be sourced from. Total net revenues by geographic area are presented as follows: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ PRC 85,384 50,141 199,301 165,704 United States 5,696 — 9,473 133,650 Other — — — 71,966 Total 91,080 50,141 208,774 371,320 |
Description of Business, Basi_2
Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of presentation and consolidation | Basis of presentation and consolidation The accompanying condensed consolidated balance sheet as of September 30, 2020, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2020 and 2019, the condensed consolidated statements of cash flows for the nine months ended September 30, 2020 and 2019, and the condensed consolidated statements of shareholders' equity for the three and nine months ended September 30, 2020 and 2019, 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, 2019 (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 the operations for the three and nine months ended September 30, 2020 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. Noncontrolling interests are recognized to reflect the portion of the equity of subsidiaries which are not attributable, directly or indirectly, to the controlling shareholders. The Company consolidates its interests in its joint venture, BeiGene Biologics Co., Ltd. ("BeiGene Biologics"), under the voting model and recognizes the minority shareholder's equity interest as a noncontrolling interest in its condensed consolidated financial statements. In September 2020, BeiGene (Hong Kong) Co., Limited ("BeiGene HK") entered into a share purchase agreement with the minority shareholder to acquire its equity interest in BeiGene Biologics. The share purchase is expected to be completed in the fourth quarter of 2020. |
Use of estimates | Use of estimates The preparation of the unaudited interim condensed 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 the standalone selling price of each performance obligation in the Company’s revenue arrangements, estimating the fair value of net assets acquired in business combinations, assessing the impairment of long-lived assets, valuation and recognition of share-based compensation expenses, realizability of deferred tax assets, estimating uncertain tax positions, 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. Actual results could differ from these estimates. |
Recent accounting pronouncements | Recent accounting pronouncements New accounting standards which have been adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses . Subsequently, the FASB issued ASU 2019-05, Financial Instruments- Credit Losses (Topic 326): Targeted Transition Relief and ASU 2019-11 Codification Improvements to Topic 326, Financial Instruments- Credit Losses (collectively, the "Credit Loss ASUs"). The Credit Loss ASUs change the methodology to be used to measure credit losses for certain financial instruments and financial assets, including trade receivables. The new methodology requires the recognition of an allowance that reflects the current estimate of credit losses expected to be incurred over the life of the financial asset. This new standard also requires that credit losses related to available-for-sale debt securities be recorded as an allowance through net income rather than reducing the carrying amount under the current, other-than-temporary-impairment model. The Company adopted the standard on January 1, 2020. Based on the composition of the Company's trade receivables and investment portfolio, the adoption of this standard did not have a material impact on the Company’s financial position or results of operations upon adoption. The Company has updated its accounting policy for trade accounts receivable and is providing additional disclosure about its allowance for credit losses, as required by the standard, upon adoption. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurement . The update eliminates, modifies, and adds certain disclosure requirements for fair value measurements. The added disclosure requirements and the modified disclosure on the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented. All other changes to disclosure requirements in this update should be applied retrospectively to all periods presented upon their effective date. The Company adopted this standard on January 1, 2020. There was no material impact to the Company's financial position or results of operations upon adoption. In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract . This update requires a customer in a cloud computing arrangement that is a service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to defer and recognize as an asset. This guidance should be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. The Company adopted this standard on January 1, 2020. There was no material impact to the Company's financial position or results of operations upon adoption. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 . This update clarifies that certain transactions between participants in a collaborative arrangement should be accounted for under ASC 606 when the counterparty is a customer and precludes an entity from presenting consideration from a transaction in a collaborative arrangement as revenue from contracts with customers if the counterparty is not a customer for that transaction. This guidance should be applied retrospectively to the date of initial application of Topic 606. The Company adopted this standard on January 1, 2020. There was no material impact to the Company's financial position or results of operations upon adoption. New accounting standards which have not yet been adopted In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes . This update simplifies the accounting for income taxes as part of the FASB's overall initiative to reduce complexity in accounting standards. The amendments include removal of certain exceptions to the general principles of ASC 740, Income taxes , and simplification in several other areas such as accounting for a franchise tax (or similar tax) that is partially based on income. The update is effective in fiscal years beginning after December 15, 2020, and interim periods therein, and early adoption is permitted. Certain amendments in this update should be applied retrospectively or modified retrospectively, and all other amendments should be applied prospectively. The Company is currently evaluating the impact on its financial statements of adopting this guidance. 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, 2019. |
Accounts Receivable and Allowance for Credit Losses | Accounts Receivable and Allowance for Credit Losses Trade accounts receivable are recorded at their invoiced amounts, net of trade discounts and allowances as well as an allowance for credit losses. The allowance for credit losses reflects the Company's current estimate of credit losses expected to be incurred over the life of the receivables. The Company considers various factors in establishing, monitoring, and adjusting its allowance for credit losses including the aging of receivables and aging trends, customer creditworthiness and specific exposures related to particular customers. The Company also monitors other risk factors and forward-looking information, such as country specific risks and economic factors that may affect a customer's ability to pay in establishing and adjusting its allowance for credit losses. Accounts receivable are written off after all collection efforts have ceased. Except for the changes to the Company’s significant accounting policies related to the adoption of the Credit Loss ASUs, there have been no other material changes to the Company’s significant accounting policies as of and for the nine months ended September 30, 2020, as compared to the significant accounting policies described in the Annual Report. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets measured at fair value on a recurring basis | The following tables present the Company’s financial assets and liabilities measured and recorded at fair value on a recurring basis using the above input categories as of September 30, 2020 and December 31, 2019: Quoted Price in Active Significant Market for Other Significant Identical Observable Unobservable Assets Inputs Inputs As of September 30, 2020 (Level 1) (Level 2) (Level 3) $ $ $ Short-term investments (Note 4): U.S. treasury securities 3,254,300 — — Cash equivalents: U.S. treasury securities 634,655 — — Money market funds 236,500 — — Other non-current assets: Equity securities (Note 4) 9,513 5,703 — Total 4,134,968 5,703 — Quoted Price in Active Significant Market for Other Significant Identical Observable Unobservable Assets Inputs Inputs As of December 31, 2019 (Level 1) (Level 2) (Level 3) $ $ $ Short-term investments (Note 4): U.S. treasury securities 364,728 — — Cash equivalents U.S. treasury securities 16,442 — — Money market funds 50,461 — — Total 431,631 — — |
Collaborative Arrangements (Tab
Collaborative Arrangements (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Research and Development [Abstract] | |
Schedule of collaboration agreements | Amounts recorded related to the cash proceeds received from the Amgen collaboration for the nine months ended September 30, 2020 were as follows: Nine Months Ended September 30, 2020 $ Fair value of equity issued to Amgen 2,162,407 Fair value of research and development cost share liability 616,834 Total cash proceeds 2,779,241 Amounts recorded related to the Company's portion of the co-development funding on the pipeline assets for the three and nine months ended September 30, 2020 were as follows: Three Months Ended Nine Months Ended September 30, September 30, 2020 2020 $ $ Research and development expense 30,795 87,498 Amortization of research and development cost share liability 30,056 85,296 Total amount due to Amgen for BeiGene's portion of the development funding 60,851 172,794 Total amount of development funding paid or payable in cash 57,201 169,144 Total amount of development funding paid with development services 3,650 3,650 As of September 30, 2020 Remaining portion of development funding cap 1,077,206 At September 30, 2020, the research and development cost share liability recorded in the Company's balance sheet was as follows: As of September 30, 2020 $ Research and development cost share liability, current portion 147,387 Research and development cost share liability, non-current portion 384,151 Total research and development cost share liability 531,538 |
Schedule of amounts and classification of reimbursement expense | The total reimbursement due under the commercial profit-sharing agreement for in-line product sales is classified in the income statement for the three and nine months ended September 30, 2020 as follows: Three Months Ended Nine Months Ended September 30, September 30, 2020 2020 $ $ Cost of sales - product (1,023) (1,023) Research and development 61 61 Selling, general and administrative (3,667) (3,667) Total (4,629) (4,629) |
Schedule of net product sales | The following table summarizes total collaboration revenue recognized related to the BMS collaboration for the three and nine months ended September 30, 2020 and 2019: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ Reimbursement of research and development costs — — — 27,634 Research and development service revenue — — — 27,982 Other — — — 150,000 Total — — — 205,616 Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Research and development payments due to Collaboration Partners $ $ $ $ Upfront payments 66,500 — 109,500 30,000 Milestone payments 1,000 — 6,000 — Total 67,500 — 115,500 30,000 Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ Product revenue – gross 95,333 52,461 216,210 169,730 Less: Rebates and sales returns (4,253) (2,320) (7,436) (4,026) Product revenue – net 91,080 50,141 208,774 165,704 The following table disaggregates net product sales by product for the three and nine months ended September 30, 2020 and September 30, 2019: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ Tislelizumab 49,934 — 99,877 — BRUKINSA® 15,662 — 23,353 — REVLIMID® 14,067 19,019 38,914 58,976 VIDAZA® 8,366 8,624 26,198 22,365 ABRAXANE® — 22,498 17,381 84,363 XGEVA® 3,051 — 3,051 — Total product revenue – net 91,080 50,141 208,774 165,704 |
Restricted Cash and Investmen_2
Restricted Cash and Investments (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of short-term investments | Short-term investments as of September 30, 2020 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 3,252,873 1,427 — 3,254,300 Total 3,252,873 1,427 — 3,254,300 Short-term investments as of December 31, 2019 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 363,440 1,288 — 364,728 Total 363,440 1,288 — 364,728 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | The Company’s inventory balance consisted of the following: As of September 30, December 31, 2020 2019 $ $ Raw materials 1,235 — Work in process — — Finished goods 34,290 28,553 Total inventories 35,525 28,553 |
Property, plant and equipment (
Property, plant and equipment (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Property, Plant and Equipment [Abstract] | |
Schedule of components of property and equipment | Property, plant and equipment are recorded at cost and consisted of the following: As of September 30, December 31, 2020 2019 $ $ Laboratory equipment 62,402 47,154 Leasehold improvements 29,225 24,008 Building 111,813 109,514 Manufacturing equipment 70,081 62,775 Software, electronics and office equipment 18,569 14,705 Property, plant and equipment, at cost 292,090 258,156 Less accumulated depreciation (61,443) (36,709) Construction in progress 60,571 20,955 Property, plant and equipment, net 291,218 242,402 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of intangible assets outstanding | Intangible assets as of September 30, 2020 and December 31, 2019 are summarized as follows: As of September 30, 2020 December 31, 2019 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 (2,312) 5,188 7,500 (1,750) 5,750 Trading license 816 (816) — 816 (720) 96 Total finite-lived intangible assets 8,316 (3,128) 5,188 8,316 (2,470) 5,846 |
Supplemental Balance Sheet In_2
Supplemental Balance Sheet Information (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Balance Sheet Related Disclosures [Abstract] | |
Allowance for credit receivable rollforward | The roll-forward of the allowance for credit losses related to trade accounts receivable for the nine months ended September 30, 2020 consists of the following activity: Allowance for Credit Losses $ Balance as of December 31, 2019 — Current period provision for expected credit losses 114 Amounts written-off — Recoveries of amounts previously written-off — Balance as of September 30, 2020 114 |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets consist of the following: As of September 30, December 31, 2020 2019 $ $ Prepaid research and development costs 76,498 65,886 Prepaid taxes 14,192 9,498 Payroll tax receivables 13,537 5,365 Interest receivable 5,792 1,932 Prepaid insurance 3,775 711 Prepaid manufacturing costs 22,136 3,829 Income tax receivable 8,062 — Other 6,888 3,017 Total 150,880 90,238 |
Schedule of other non-current assets | Other non-current assets consist of the following: As of September 30, December 31, 2020 2019 $ $ Goodwill 109 109 Prepayment of property and equipment 32,931 10,289 Prepayment of facility capacity expansion activities (1) 30,366 24,881 Prepaid VAT 29,413 29,967 Prepayment for JV share repurchase 28,723 — Rental deposits and other 4,302 3,209 Equity method investments (Note 4) 36,756 — Total 162,600 68,455 (1) Represents payments for facility expansions under commercial supply agreements. The payments will provide future benefit to the Company through credits on future supply purchases. |
Schedule of accrued expenses and other payables | Accrued expenses and other payables consist of the following: As of September 30, December 31, 2020 2019 $ $ Compensation related 71,255 54,156 External research and development related 139,990 62,794 Commercial activities 40,179 25,645 Income tax and other taxes 19,815 9,648 Sales rebates and returns related 7,524 3,198 Professional fees and other 560 8,115 Total 279,323 163,556 |
Schedule of other long-term liabilities | Other long-term liabilities consist of the following: As of September 30, December 31, 2020 2019 $ $ Deferred government grant income 47,720 46,391 Other 170 171 Total 47,890 46,562 |
Product Revenue (Tables)
Product Revenue (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of net product sales | The following table summarizes total collaboration revenue recognized related to the BMS collaboration for the three and nine months ended September 30, 2020 and 2019: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ Reimbursement of research and development costs — — — 27,634 Research and development service revenue — — — 27,982 Other — — — 150,000 Total — — — 205,616 Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Research and development payments due to Collaboration Partners $ $ $ $ Upfront payments 66,500 — 109,500 30,000 Milestone payments 1,000 — 6,000 — Total 67,500 — 115,500 30,000 Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ Product revenue – gross 95,333 52,461 216,210 169,730 Less: Rebates and sales returns (4,253) (2,320) (7,436) (4,026) Product revenue – net 91,080 50,141 208,774 165,704 The following table disaggregates net product sales by product for the three and nine months ended September 30, 2020 and September 30, 2019: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ Tislelizumab 49,934 — 99,877 — BRUKINSA® 15,662 — 23,353 — REVLIMID® 14,067 19,019 38,914 58,976 VIDAZA® 8,366 8,624 26,198 22,365 ABRAXANE® — 22,498 17,381 84,363 XGEVA® 3,051 — 3,051 — Total product revenue – net 91,080 50,141 208,774 165,704 |
Schedule of accrued sales rebates and returns | The following table presents the roll-forward of accrued sales rebates and returns for the nine months ended September 30, 2020 and September 30, 2019: Sales Rebates $ Balance as of December 31, 2018 4,749 Accrual 4,026 Payments (5,013) Balance as of September 30, 2019 3,762 Balance as of December 31, 2019 3,198 Accrual 7,436 Payments (3,110) Balance as of September 30, 2020 7,524 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Earnings Per Share [Abstract] | |
Schedule of the calculation of basic and diluted net (loss) income per ordinary share | Loss per share was calculated as follows: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ Numerator: Net loss attributable to BeiGene, Ltd. (425,224) (307,357) (1,124,161) (560,567) Denominator: Weighted average shares outstanding, basic and diluted 1,148,973,077 781,482,459 1,052,940,583 777,938,599 Net loss per share attributable to BeiGene, Ltd., basic and diluted (0.37) (0.39) (1.07) (0.72) |
Share-Based Compensation Expe_2
Share-Based Compensation Expense (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Summary of total compensation cost recognized | The following table summarizes total share-based compensation expense recognized for the three and nine months ended September 30, 2020 and 2019: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ Research and development 25,410 20,674 69,521 54,599 Selling, general and administrative 24,887 16,144 64,499 41,213 Total 50,297 36,818 134,020 95,812 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Schedule of accumulated other comprehensive income | The movement of accumulated other comprehensive income was as follows: Unrealized Foreign Currency Gains on Translation Available-for-Sale Adjustments Securities Total $ $ $ Balance as of December 31, 2019 (9,291) 1,290 (8,001) Other comprehensive income before reclassifications 7,398 1,734 9,132 Amounts reclassified from accumulated other comprehensive income — (1,550) (1,550) Net-current period other comprehensive income 7,398 184 7,582 Balance as of September 30, 2020 (1,893) 1,474 (419) |
Segment and geographic inform_2
Segment and geographic information (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Segment Reporting [Abstract] | |
Schedule of net product revenues by geographic area | Total net revenues by geographic area are presented as follows: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 $ $ $ $ PRC 85,384 50,141 199,301 165,704 United States 5,696 — 9,473 133,650 Other — — — 71,966 Total 91,080 50,141 208,774 371,320 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Assets: | ||
Short-term investments | $ 3,254,300,000 | $ 364,728,000 |
U.S. treasury securities | ||
Assets: | ||
Short-term investments | 3,254,300,000 | 364,728,000 |
Recurring basis | ||
Liabilities: | ||
Liabilities measured and recorded at fair value | 0 | 0 |
Recurring basis | (Level 1) | ||
Assets: | ||
Equity securities (Note 4) | 9,513,000 | |
Total | 4,134,968,000 | 431,631,000 |
Recurring basis | (Level 1) | U.S. treasury securities | ||
Assets: | ||
Short-term investments | 3,254,300,000 | 364,728,000 |
Cash equivalents: | 634,655,000 | 16,442,000 |
Recurring basis | (Level 1) | Money market funds | ||
Assets: | ||
Cash equivalents: | 236,500,000 | 50,461,000 |
Recurring basis | (Level 2) | ||
Assets: | ||
Equity securities (Note 4) | 5,703,000 | |
Total | 5,703,000 | 0 |
Recurring basis | (Level 2) | U.S. treasury securities | ||
Assets: | ||
Short-term investments | 0 | 0 |
Cash equivalents: | 0 | 0 |
Recurring basis | (Level 2) | Money market funds | ||
Assets: | ||
Cash equivalents: | 0 | 0 |
Recurring basis | (Level 3) | ||
Assets: | ||
Equity securities (Note 4) | 0 | |
Total | 0 | 0 |
Recurring basis | (Level 3) | U.S. treasury securities | ||
Assets: | ||
Short-term investments | 0 | 0 |
Cash equivalents: | 0 | 0 |
Recurring basis | (Level 3) | Money market funds | ||
Assets: | ||
Cash equivalents: | $ 0 | $ 0 |
Collaborative Arrangements - Am
Collaborative Arrangements - Amgen (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 02, 2020 | Sep. 30, 2020 |
Common Stock | ||
Research and Development Arrangement, Contract to Perform for Others | ||
Share price, ADS (in dollars per share) | $ 132.74 | |
Proceeds from ADS shares | $ 2,109,902 | |
Beigene | Amgen, Inc | ||
Research and Development Arrangement, Contract to Perform for Others | ||
Minority interest in investment (as a percent) | 20.50% | |
Amgen, Inc | ||
Research and Development Arrangement, Contract to Perform for Others | ||
Maximum cash and development services commitment | $ 1,250,000 | |
Shares issued (in shares) | 15,895,001 | |
Per share acquisition price (in dollars per share) | $ 174.85 | |
Fair value of cost share liability | $ 601,857 | |
Payments to acquire equity interest | 2,779,241 | |
Fair value of equity issued to Amgen | 2,162,407 | $ 2,162,407 |
Fair value of research and development cost share liability | $ 616,834 | $ 616,834 |
Amgen, Inc | Minimum | ||
Research and Development Arrangement, Contract to Perform for Others | ||
Commercialization term (years) | 5 years | |
Amgen, Inc | Maximum | ||
Research and Development Arrangement, Contract to Perform for Others | ||
Commercialization term (years) | 7 years |
Collaborative Arrangements - De
Collaborative Arrangements - Details of Proceeds From Transaction (Details) - Amgen, Inc - USD ($) $ in Thousands | Jan. 02, 2020 | Sep. 30, 2020 |
Research and Development Arrangement, Contract to Perform for Others | ||
Fair value of equity issued to Amgen | $ 2,162,407 | $ 2,162,407 |
Fair value of research and development cost share liability | $ 616,834 | 616,834 |
Total cash proceeds | $ 2,779,241 |
Collaborative Arrangements - Fu
Collaborative Arrangements - Funding Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Research and Development Arrangement, Contract to Perform for Others | ||||
Research and development expense | $ 349,070 | $ 236,968 | $ 939,340 | $ 644,079 |
Amgen, Inc | ||||
Research and Development Arrangement, Contract to Perform for Others | ||||
Research and development expense | 30,795 | 87,498 | ||
Amortization of research and development cost share liability | 30,056 | 85,296 | ||
Total amount due to Amgen for BeiGene's portion of the development funding | 60,851 | 172,794 | ||
Total amount of development funding paid or payable in cash | 57,201 | 169,144 | ||
Total amount of development funding paid with development services | 3,650 | 3,650 | ||
Remaining portion of development funding cap | $ 1,077,206 | $ 1,077,206 |
Collaborative Arrangements - Fi
Collaborative Arrangements - Financing Liability (Details) - Amgen, Inc $ in Thousands | Sep. 30, 2020USD ($) |
Research and Development Arrangement, Contract to Perform for Others | |
Research and development cost share liability, current portion | $ 147,387 |
Research and development cost share liability, non-current portion | 384,151 |
Total research and development cost share liability | $ 531,538 |
Collaborative Arrangements - _2
Collaborative Arrangements - Amounts and Classification of Payments (Income/(Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2020 | Sep. 30, 2020 | |
Research and Development Arrangement, Contract to Perform for Others | ||
Total | $ 4,629 | $ 4,629 |
Cost of sales - product | ||
Research and Development Arrangement, Contract to Perform for Others | ||
Total | 1,023 | 1,023 |
Research and development | ||
Research and Development Arrangement, Contract to Perform for Others | ||
Total | (61) | (61) |
Selling, general and administrative | ||
Research and Development Arrangement, Contract to Perform for Others | ||
Total | $ 3,667 | $ 3,667 |
Collaborative Arrangements - Co
Collaborative Arrangements - Collaboration Revenue Recognized (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenues | ||||
Revenues | $ 91,080,000 | $ 50,141,000 | $ 208,774,000 | $ 371,320,000 |
Collaboration | ||||
Revenues | ||||
Revenues | 0 | 0 | 0 | 205,616,000 |
Reimbursement of research and development costs | ||||
Revenues | ||||
Revenues | 0 | 0 | 0 | 27,634,000 |
Research and development service revenue | ||||
Revenues | ||||
Revenues | 0 | 0 | 0 | 27,982,000 |
Other | ||||
Revenues | ||||
Revenues | $ 0 | $ 0 | $ 0 | $ 150,000,000 |
Collaborative Arrangements - _3
Collaborative Arrangements - Collaboration Revenue Recognized Narratives (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Research and Development Arrangement, Contract to Perform for Others | ||||
Revenues | $ 91,080,000 | $ 50,141,000 | $ 208,774,000 | $ 371,320,000 |
Collaboration revenue | ||||
Research and Development Arrangement, Contract to Perform for Others | ||||
Revenues | 0 | 0 | 0 | 205,616,000 |
Reimbursement of research and development costs | ||||
Research and Development Arrangement, Contract to Perform for Others | ||||
Revenues | 0 | 0 | 0 | 27,634,000 |
Research and development service revenue | ||||
Research and Development Arrangement, Contract to Perform for Others | ||||
Revenues | 0 | 0 | 0 | 27,982,000 |
Other | ||||
Research and Development Arrangement, Contract to Perform for Others | ||||
Revenues | $ 0 | $ 0 | $ 0 | $ 150,000,000 |
Collaborative Arrangements - In
Collaborative Arrangements - In Licensing Agreements (Details) $ in Thousands | Oct. 30, 2020USD ($) | Jul. 17, 2020USD ($)application | Jan. 13, 2020USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Aug. 22, 2020USD ($) |
Research and Development Arrangement, Contract to Perform for Others | ||||||||
Upfront payments | $ 66,500 | $ 0 | $ 109,500 | $ 30,000 | ||||
Milestone payments | 1,000 | 0 | 6,000 | 0 | ||||
Total | $ 67,500 | $ 0 | $ 115,500 | $ 30,000 | ||||
EUSA Pharma | ||||||||
Research and Development Arrangement, Contract to Perform for Others | ||||||||
Upfront payments | $ 40,000 | |||||||
Maximum milestone payments | $ 160,000 | |||||||
Assembly Biosciences, Inc. | ||||||||
Research and Development Arrangement, Contract to Perform for Others | ||||||||
Upfront payments | $ 40,000 | |||||||
Maximum milestone payments | $ 503,750 | |||||||
Candidates (candidates) | application | 3 | |||||||
Bio-Thera Solutions, Ltd. | ||||||||
Research and Development Arrangement, Contract to Perform for Others | ||||||||
Maximum milestone payments | $ 145,000 | |||||||
Bio-Thera Solutions, Ltd. | Subsequent Event | ||||||||
Research and Development Arrangement, Contract to Perform for Others | ||||||||
Upfront payments | $ 20,000 |
Restricted Cash and Investmen_3
Restricted Cash and Investments - Restricted Cash (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Restricted cash | $ 5,245 |
Restricted Cash and Investmen_4
Restricted Cash and Investments - Tabular Disclosure (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Short-term investments | ||
Amortized Cost | $ 3,252,873 | $ 363,440 |
Gross Unrealized Gains | 1,427 | 1,288 |
Gross Unrealized Losses | 0 | 0 |
Short-term investments | 3,254,300 | 364,728 |
U.S. treasury securities | ||
Short-term investments | ||
Amortized Cost | 3,252,873 | 363,440 |
Gross Unrealized Gains | 1,427 | 1,288 |
Gross Unrealized Losses | 0 | 0 |
Short-term investments | $ 3,254,300 | $ 364,728 |
Restricted Cash and Investmen_5
Restricted Cash and Investments - Equity Method Investment (Details) ¥ in Thousands, $ in Thousands | Jul. 23, 2020USD ($)memberapplication | Jun. 08, 2020USD ($) | Jan. 31, 2020USD ($) | Jun. 30, 2019shares | Sep. 30, 2020USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 23, 2020 | Jul. 23, 2020CNY (¥)memberapplication |
Schedule of Investments | |||||||||
Purchases of investments | $ 4,879,705 | $ 850,825 | |||||||
Gain on deconsolidation of a subsidiary | $ 11,307 | $ 0 | |||||||
Series A preferred stock | |||||||||
Schedule of Investments | |||||||||
Preferred stock ownership voting rights requirement threshold (percentage) | 70.00% | ||||||||
Leap Therapeutic, Inc | |||||||||
Schedule of Investments | |||||||||
Equity method investments (percent) | 8.10% | 8.10% | |||||||
Equity method investments, including warrants (percent) | 14.90% | 14.90% | |||||||
Gains (losses) from equity investments | $ (1,048) | $ 10,216 | |||||||
Loss from equity method investment | 1,048 | (10,216) | |||||||
Leap Therapeutic, Inc | Series B preferred stock | |||||||||
Schedule of Investments | |||||||||
Purchases of investments | $ 5,000 | ||||||||
Warrants | 5,703 | 5,703 | |||||||
Leap Therapeutic, Inc | Common Stock | |||||||||
Schedule of Investments | |||||||||
Equity investment | 9,513 | 9,513 | |||||||
MapKure | |||||||||
Schedule of Investments | |||||||||
Equity method investments (percent) | 55.60% | 71.40% | |||||||
Equity investment | 9,834 | 9,834 | |||||||
Gains (losses) from equity investments | (143) | (166) | |||||||
Gain on deconsolidation of a subsidiary | $ 11,307 | ||||||||
Equity method investments fair value | $ 10,000 | ||||||||
Loss from equity method investment | 143 | 166 | |||||||
MapKure | SpringWorks | |||||||||
Schedule of Investments | |||||||||
Equity method investments (percent) | 25.00% | ||||||||
MapKure | Two Individuals | |||||||||
Schedule of Investments | |||||||||
Equity method investments (percent) | 1.80% | ||||||||
MapKure | Series A preferred stock | |||||||||
Schedule of Investments | |||||||||
Shares owned (shares) | shares | 10,000,000 | ||||||||
MapKure | Series A preferred stock | SpringWorks | |||||||||
Schedule of Investments | |||||||||
Sale of stock shares received (in shares) | shares | 3,500,000 | ||||||||
MapKure | Series A preferred stock | Two Individuals | |||||||||
Schedule of Investments | |||||||||
Sale of stock shares received (in shares) | shares | 250,000 | ||||||||
BeiGene (Guangzhou) Co., Ltd. (“BeiGene Guangzhou”) | |||||||||
Schedule of Investments | |||||||||
Equity method investments (percent) | 60.00% | ||||||||
Invested fund amount | $ 11,782 | ¥ 80,000 | |||||||
GET Biomedical Industry Investment Fund Management Co., Ltd. | |||||||||
Schedule of Investments | |||||||||
Equity method investments (percent) | 26.30% | 26.30% | |||||||
Gains (losses) from equity investments | 76 | 76 | |||||||
Loss from equity method investment | (76) | (76) | |||||||
Number of limited partners | application | 4 | 4 | |||||||
Number of general partner | application | 1 | 1 | |||||||
Limited partner agreed period | 7 years | ||||||||
Limited partner investment period | 5 years | ||||||||
Limited partner projected payback period | 2 years | ||||||||
Limited partner extended period | 2 years | ||||||||
Number of members (members) | member | 7 | 7 | |||||||
Number of members required for approval (member) | member | 5 | 5 | |||||||
Investment fund | $ 11,706 | $ 11,706 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,235 | $ 0 |
Work in process | 0 | 0 |
Finished goods | 34,290 | 28,553 |
Total inventories | $ 35,525 | $ 28,553 |
Property, plant and equipment -
Property, plant and equipment - Tabular Disclosure (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Property and equipment | ||
Property, plant and equipment, at cost | $ 292,090 | $ 258,156 |
Less accumulated depreciation | (61,443) | (36,709) |
Property, plant and equipment, net | 291,218 | 242,402 |
Laboratory equipment | ||
Property and equipment | ||
Property, plant and equipment, at cost | 62,402 | 47,154 |
Leasehold improvements | ||
Property and equipment | ||
Property, plant and equipment, at cost | 29,225 | 24,008 |
Building | ||
Property and equipment | ||
Property, plant and equipment, at cost | 111,813 | 109,514 |
Manufacturing equipment | ||
Property and equipment | ||
Property, plant and equipment, at cost | 70,081 | 62,775 |
Software, electronics and office equipment | ||
Property and equipment | ||
Property, plant and equipment, at cost | 18,569 | 14,705 |
Construction in progress | ||
Property and equipment | ||
Property, plant and equipment, at cost | $ 60,571 | $ 20,955 |
Property, plant and equipment_2
Property, plant and equipment - Depreciation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Property and equipment | ||||
Depreciation expense | $ 8,157 | $ 3,691 | $ 23,303 | $ 10,139 |
Guangzhou Biologics Business (D
Guangzhou Biologics Business (Details) | Sep. 28, 2020USD ($) | Sep. 28, 2020CNY (¥) | Sep. 24, 2020USD ($) | Apr. 30, 2017CNY (¥) | Mar. 31, 2017CNY (¥)asset | Dec. 31, 2017 | Jun. 30, 2017CNY (¥) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Oct. 09, 2020USD ($) | Sep. 30, 2020CNY (¥) | Sep. 28, 2020CNY (¥) | Dec. 31, 2019USD ($) | Sep. 30, 2018 | Apr. 14, 2017CNY (¥) | Mar. 07, 2017CNY (¥) |
Organization | ||||||||||||||||
Capital contribution from noncontrolling interest | $ | $ 0 | $ 4,000,000 | ||||||||||||||
Shareholder loan | $ | 0 | $ 157,384,000 | ||||||||||||||
Zhuhai Hillhouse | Letter of Credit | ||||||||||||||||
Organization | ||||||||||||||||
Maximum borrowing capacity | $ 58,912,000 | ¥ 400,000,000 | ||||||||||||||
Shareholder Loan | Convertible Debt | Investor | ||||||||||||||||
Organization | ||||||||||||||||
Face amount | ¥ 900,000,000 | |||||||||||||||
Shareholder loan | ¥ 900,000,000 | |||||||||||||||
Senior Loan | Senior Notes | China Minsheng Bank | ||||||||||||||||
Organization | ||||||||||||||||
Maximum borrowing capacity | $ | 200,000,000 | $ 200,000 | ||||||||||||||
Extension Period | 12 months | |||||||||||||||
Senior loan Reserved For JV Purchase | Senior Notes | China Minsheng Bank | ||||||||||||||||
Organization | ||||||||||||||||
Maximum borrowing capacity | $ | 120,000,000 | $ 120,000,000 | ||||||||||||||
Working Capital | Senior Notes | China Minsheng Bank | ||||||||||||||||
Organization | ||||||||||||||||
Maximum borrowing capacity | $ | 80,000,000 | $ 80,000,000 | ||||||||||||||
Junior Loan | Junior Notes | Zhuhai Hillhouse | ||||||||||||||||
Organization | ||||||||||||||||
Maximum borrowing capacity | 73,640,000 | 500,000,000 | ||||||||||||||
Shareholder loan | $ 14,728,000 | ¥ 100,000,000 | ||||||||||||||
Junior Loan General Corporate Use | Junior Notes | Zhuhai Hillhouse | ||||||||||||||||
Organization | ||||||||||||||||
Maximum borrowing capacity | 14,728,000 | 100,000,000 | ||||||||||||||
JV Share Repurchase | Working Capital Facility | Subsequent Event | ||||||||||||||||
Organization | ||||||||||||||||
Maximum borrowing capacity | $ | $ 80,000,000 | |||||||||||||||
JV Share Repurchase | Acquisition Facility | Subsequent Event | ||||||||||||||||
Organization | ||||||||||||||||
Maximum borrowing capacity | $ | $ 118,320,000 | |||||||||||||||
BeiGene Biologics Co., Ltd. (BeiGene Biologics) | ||||||||||||||||
Organization | ||||||||||||||||
Ownership percentage immediately after transaction (as a percent) | 95.00% | |||||||||||||||
BeiGene (Hong Kong) Co., Limited.(“BeiGene HK”) | ||||||||||||||||
Organization | ||||||||||||||||
Cash capital contribution, agreed amount | ¥ 200,000,000 | |||||||||||||||
Minimum number of biologics assets to be contributed | asset | 1 | |||||||||||||||
BeiGene (Hong Kong) Co., Limited.(“BeiGene HK”) | Contributions One | ||||||||||||||||
Organization | ||||||||||||||||
Cash capital contribution | ¥ 137,830,000 | |||||||||||||||
BeiGene (Hong Kong) Co., Limited.(“BeiGene HK”) | Contributions Two | ||||||||||||||||
Organization | ||||||||||||||||
Cash capital contribution | ¥ 2,415,000 | |||||||||||||||
BeiGene (Hong Kong) Co., Limited.(“BeiGene HK”) | BeiGene Biologics Co., Ltd. (BeiGene Biologics) | ||||||||||||||||
Organization | ||||||||||||||||
Ownership percentage immediately after transaction (as a percent) | 95.00% | |||||||||||||||
Payment to acquire interest in JV | 28,723,000 | ¥ 195,262,000 | ||||||||||||||
BeiGene (Hong Kong) Co., Limited.(“BeiGene HK”) | BeiGene (Shanghai) Co., Ltd. (“BeiGene (Shanghai)”) | ||||||||||||||||
Organization | ||||||||||||||||
Ownership percentage immediately after transaction (as a percent) | 95.00% | |||||||||||||||
Ownership percentage immediately before transaction (as a percent) | 100.00% | |||||||||||||||
BeiGene Biologics Co., Ltd. (BeiGene Biologics) | Shareholder Loan | Convertible Debt | ||||||||||||||||
Organization | ||||||||||||||||
Face amount | 132,061,000 | 900,000,000 | ||||||||||||||
Debt instrument accrued interest | $ 36,558,000 | ¥ 249,140,000 | ||||||||||||||
BeiGene Biologics Co., Ltd. (BeiGene Biologics) | Shareholder Loan | Convertible Debt | Investor | ||||||||||||||||
Organization | ||||||||||||||||
Face amount | ¥ 900,000,000 | |||||||||||||||
Shareholder loan | ¥ 900,000,000 | |||||||||||||||
GET | ||||||||||||||||
Organization | ||||||||||||||||
Cash capital contribution, agreed amount | ¥ 100,000,000 | |||||||||||||||
Capital contribution from noncontrolling interest | ¥ 100,000,000 | |||||||||||||||
GET | BeiGene Biologics Co., Ltd. (BeiGene Biologics) | ||||||||||||||||
Organization | ||||||||||||||||
Ownership percentage immediately after transaction (as a percent) | 5.00% | |||||||||||||||
Minority interest in investment (as a percent) | 5.00% | 5.00% | 5.00% | |||||||||||||
BeiGene (Guangzhou) Co., Ltd. (“BeiGene Guangzhou”) | Baiji Shenzhou (Guangzhou) Pharmaceuticals Co., Ltd. | ||||||||||||||||
Organization | ||||||||||||||||
Ownership percentage (as a percent) | 100.00% |
Intangible Assets - Intangible
Intangible Assets - Intangible Assets Outstanding (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Finite-lived intangible assets: | ||
Gross carrying amount | $ 8,316 | $ 8,316 |
Accumulated amortization | (3,128) | (2,470) |
Intangible assets, net | 5,188 | 5,846 |
Product distribution rights | ||
Finite-lived intangible assets: | ||
Gross carrying amount | 7,500 | 7,500 |
Accumulated amortization | (2,312) | (1,750) |
Intangible assets, net | 5,188 | 5,750 |
Trading license | ||
Finite-lived intangible assets: | ||
Gross carrying amount | 816 | 816 |
Accumulated amortization | (816) | (720) |
Intangible assets, net | $ 0 | $ 96 |
Intangible Assets - Useful Life
Intangible Assets - Useful Life (Details) | 9 Months Ended |
Sep. 30, 2020 | |
Product distribution rights | |
Other intangible assets | |
Useful life | 10 years |
Intangible Assets - Amortizatio
Intangible Assets - Amortization Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Finite-lived intangible assets: | ||||
Amortization of intangible assets | $ 187 | $ 331 | $ 658 | $ 994 |
Intangible Assets - Expected Am
Intangible Assets - Expected Amortization Expense (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Expected amortization expense | |
Remainder of 2020 | $ 188 |
2021 | 750 |
2022 | 750 |
2023 | 750 |
2024 | 750 |
2025 and thereafter | $ 2,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income taxes | ||||
Income tax benefit | $ 8,423 | $ 3,217 | $ 8,344 | $ 569 |
Taxes receivable | 5,586 | 5,586 | ||
Unrecognized tax benefits | 6,542 | 6,542 | ||
Increase in uncertain tax position | $ 759 | $ 1,909 |
Supplemental Balance Sheet In_3
Supplemental Balance Sheet Information - Allowance for credit losses (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Accounts Receivable, Allowance for Credit Loss | |
Balance as of December 31, 2019 | $ 0 |
Current period provision for expected credit losses | 114 |
Amounts written-off | 0 |
Recoveries of amounts previously written-off | 0 |
Balance as of September 30, 2020 | $ 114 |
Supplemental Balance Sheet In_4
Supplemental Balance Sheet Information - Prepaid expenses and other current assets (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Prepaid expenses and other current assets: | ||
Prepaid research and development costs | $ 76,498 | $ 65,886 |
Prepaid taxes | 14,192 | 9,498 |
Payroll tax receivables | 13,537 | 5,365 |
Interest receivable | 5,792 | 1,932 |
Prepaid insurance | 3,775 | 711 |
Prepaid manufacturing costs | 22,136 | 3,829 |
Income tax receivable | 8,062 | 0 |
Other | 6,888 | 3,017 |
Total | $ 150,880 | $ 90,238 |
Supplemental Balance Sheet In_5
Supplemental Balance Sheet Information - Other non-current assets (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Other non-current assets: | ||
Goodwill | $ 109 | $ 109 |
Prepayment of property and equipment | 32,931 | 10,289 |
Prepayment of facility capacity expansion activities | 30,366 | 24,881 |
Prepaid VAT | 29,413 | 29,967 |
Prepayment for JV share repurchase | 28,723 | 0 |
Rental deposits and other | 4,302 | 3,209 |
Equity method investments (Note 4) | 36,756 | 0 |
Total | $ 162,600 | $ 68,455 |
Supplemental Balance Sheet In_6
Supplemental Balance Sheet Information - Accrued expenses and other payables (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Accrued expenses and other payables | ||
Compensation related | $ 71,255 | $ 54,156 |
External research and development related | 139,990 | 62,794 |
Commercial activities | 40,179 | 25,645 |
Income tax and other taxes | 19,815 | 9,648 |
Sales rebates and returns related | 7,524 | 3,198 |
Professional fees and other | 560 | 8,115 |
Total | $ 279,323 | $ 163,556 |
Supplemental Balance Sheet In_7
Supplemental Balance Sheet Information - Other long-term liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Other long-term liabilities | ||
Deferred government grant income | $ 47,720 | $ 46,391 |
Other | 170 | 171 |
Total | $ 47,890 | $ 46,562 |
Debt (Details)
Debt (Details) | Sep. 28, 2020USD ($) | Sep. 28, 2020CNY (¥) | Sep. 24, 2020USD ($)option | Sep. 01, 2020USD ($) | Sep. 01, 2020CNY (¥) | Jun. 11, 2020USD ($) | May 21, 2020CNY (¥) | Apr. 30, 2020USD ($) | Apr. 30, 2020CNY (¥) | Jan. 22, 2020CNY (¥) | Jan. 13, 2020CNY (¥) | Apr. 04, 2018USD ($) | Apr. 04, 2018CNY (¥) | Mar. 07, 2017CNY (¥) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2020CNY (¥) | Sep. 30, 2019USD ($) | Oct. 09, 2020USD ($) | Sep. 30, 2020CNY (¥) | Sep. 28, 2020CNY (¥) | Jun. 11, 2020CNY (¥) | Dec. 31, 2019USD ($) | Apr. 14, 2017CNY (¥) | Mar. 31, 2017 |
Long-term bank loan | ||||||||||||||||||||||||||
Proceeds from long-term loans | $ 64,288,000 | $ 67,489,000 | ||||||||||||||||||||||||
Long-term debt | $ 151,551,000 | 151,551,000 | $ 83,311,000 | |||||||||||||||||||||||
Repayments of det | 132,061,000 | 8,394,000 | ||||||||||||||||||||||||
Interest paid | 41,577,000 | 3,335,000 | ||||||||||||||||||||||||
GET | BeiGene Biologics Co., Ltd. (BeiGene Biologics) | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Minority interest in investment (as a percent) | 5.00% | 5.00% | 5.00% | |||||||||||||||||||||||
Loans Payable | China Industrial Bank | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Short-term debt | 20,619,000 | 20,619,000 | ¥ 140,000,000 | |||||||||||||||||||||||
Loans Payable | China Industrial Bank | BeiGene (Beijing) Co., Ltd. (BeiGene Beijing) | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Debt instrument term (in years) | 1 year | |||||||||||||||||||||||||
Proceeds from long-term loans | $ 14,612,000 | ¥ 100,000,000 | ||||||||||||||||||||||||
Maximum borrowing capacity | $ 26,510,000 | ¥ 180,000,000 | ||||||||||||||||||||||||
Fixed annual interest rate (as a percent) | 4.40% | 4.40% | ||||||||||||||||||||||||
Short-term debt | 14,728,000 | 14,728,000 | ¥ 100,000,000 | |||||||||||||||||||||||
Loans Payable | China Merchants Bank | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Short-term debt | $ 14,728,000 | 14,728,000 | ||||||||||||||||||||||||
Short Term Debt Due Jan 2022 | Loans Payable | China Industrial Bank | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Debt instrument term (in years) | 1 year | |||||||||||||||||||||||||
Proceeds from long-term loans | 20,148,000 | ¥ 140,000,000 | ||||||||||||||||||||||||
Maximum borrowing capacity | ¥ | ¥ 200,000,000 | |||||||||||||||||||||||||
Fixed annual interest rate (as a percent) | 5.60% | |||||||||||||||||||||||||
Short Term Debt Due Mar 2022 | Loans Payable | China Merchants Bank | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Debt instrument term (in years) | 1 year | |||||||||||||||||||||||||
Proceeds from long-term loans | $ 14,223,000 | ¥ 100,000,000 | ||||||||||||||||||||||||
Maximum borrowing capacity | ¥ | ¥ 100,000,000 | |||||||||||||||||||||||||
Fixed annual interest rate (as a percent) | 4.50% | 4.50% | 4.50% | |||||||||||||||||||||||
Short-term debt | ¥ | ¥ 100,000,000 | |||||||||||||||||||||||||
JV Share Repurchase | Working Capital Facility | Subsequent Event | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Maximum borrowing capacity | $ 80,000,000 | |||||||||||||||||||||||||
JV Share Repurchase | Acquisition Facility | Subsequent Event | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Maximum borrowing capacity | $ 118,320,000 | |||||||||||||||||||||||||
Loans Payable | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Interest expense | $ 1,621,000 | $ 1,287,000 | $ 5,228,000 | 3,395,000 | ||||||||||||||||||||||
Interest capitalized | 97,000 | 875,000 | $ 214,000 | 2,254,000 | ||||||||||||||||||||||
Loans Payable | Long Term Bank Loan April 2018 | China Construction Bank | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Debt instrument term (in years) | 9 years | 9 years | ||||||||||||||||||||||||
Proceeds from long-term loans | $ 85,422,000 | ¥ 580,000,000 | ||||||||||||||||||||||||
Factory fixed assets carrying amount | $ 142,121,000 | |||||||||||||||||||||||||
Interest rate during the period (percent) | 4.90% | 4.90% | ||||||||||||||||||||||||
Loans Payable | Long Term Debt Due April 2022 - 2029 | China Merchants Bank | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Debt instrument term (in years) | 9 years | |||||||||||||||||||||||||
Proceeds from long-term loans | $ 49,560,000 | ¥ 350,000,000 | ||||||||||||||||||||||||
Interest rate during the period (percent) | 4.40% | 4.40% | ||||||||||||||||||||||||
Maximum borrowing capacity | ¥ | ¥ 1,100,000,000 | |||||||||||||||||||||||||
Long-term debt | 51,548,000 | $ 51,548,000 | ¥ 350,000,000 | |||||||||||||||||||||||
Senior Notes | Senior Loan | China Minsheng Bank | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Maximum borrowing capacity | $ 200,000,000 | $ 200,000 | ||||||||||||||||||||||||
Extension options (option) | option | 2 | |||||||||||||||||||||||||
Extension Period | 12 months | |||||||||||||||||||||||||
Senior Notes | Senior loan Reserved For JV Purchase | China Minsheng Bank | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Maximum borrowing capacity | 120,000,000 | $ 120,000,000 | ||||||||||||||||||||||||
Convertible Debt | Shareholder Loan | Investor | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Interest capitalized | 0 | 958,000 | 0 | 2,462,000 | ||||||||||||||||||||||
Face amount | ¥ | ¥ 900,000,000 | |||||||||||||||||||||||||
Shareholder loan | ¥ | ¥ 900,000,000 | |||||||||||||||||||||||||
Shareholder loan interest rate (as a percent) | 8.00% | |||||||||||||||||||||||||
Interest expense incurred due to a related party | $ 2,518,000 | $ 2,671,000 | $ 7,621,000 | $ 7,847,000 | ||||||||||||||||||||||
Convertible Debt | Shareholder Loan | Investor | BeiGene Biologics Co., Ltd. (BeiGene Biologics) | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Repayments of det | 132,061,000 | ¥ 900,000,000 | ||||||||||||||||||||||||
Interest paid | $ 36,558,000 | ¥ 249,140,000 | ||||||||||||||||||||||||
Junior Notes | Junior Loan | Zhuhai Hillhouse | ||||||||||||||||||||||||||
Long-term bank loan | ||||||||||||||||||||||||||
Debt instrument term (in years) | 37 months | 37 months | ||||||||||||||||||||||||
Fully repaid business days | 10 days | |||||||||||||||||||||||||
Maximum borrowing capacity | $ 73,640,000 | ¥ 500,000,000 | ||||||||||||||||||||||||
Fixed annual interest rate (as a percent) | 5.80% | 5.80% |
Product Revenue - Product Sales
Product Revenue - Product Sales (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenues | ||||
Product revenue – net | $ 91,080 | $ 50,141 | $ 208,774 | $ 371,320 |
Product | ||||
Revenues | ||||
Product revenue – gross | 95,333 | 52,461 | 216,210 | 169,730 |
Less: Rebates and sales returns | (4,253) | (2,320) | (7,436) | (4,026) |
Product revenue – net | 91,080 | 50,141 | 208,774 | 165,704 |
Product | Tislelizumab | ||||
Revenues | ||||
Product revenue – net | 49,934 | 0 | 99,877 | 0 |
Product | BRUKINSA® | ||||
Revenues | ||||
Product revenue – net | 15,662 | 0 | 23,353 | 0 |
Product | REVLIMID® | ||||
Revenues | ||||
Product revenue – net | 14,067 | 19,019 | 38,914 | 58,976 |
Product | VIDAZA® | ||||
Revenues | ||||
Product revenue – net | 8,366 | 8,624 | 26,198 | 22,365 |
Product | ABRAXANE® | ||||
Revenues | ||||
Product revenue – net | 0 | 22,498 | 17,381 | 84,363 |
Product | XGEVA® | ||||
Revenues | ||||
Product revenue – net | $ 3,051 | $ 0 | $ 3,051 | $ 0 |
Product Revenue - Accrued Sales
Product Revenue - Accrued Sales Rebates and Returns (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Accrued Sales Rebates and Returns | ||
Beginning balance | $ 3,198 | |
Ending balance | 7,524 | |
Product | ||
Accrued Sales Rebates and Returns | ||
Beginning balance | 3,198 | $ 4,749 |
Accrual | 7,436 | 4,026 |
Payments | (3,110) | (5,013) |
Ending balance | $ 7,524 | $ 3,762 |
Loss Per Share (Details)
Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Numerator: | ||||
Net loss attributable to BeiGene, Ltd. | $ (425,224) | $ (307,357) | $ (1,124,161) | $ (560,567) |
Denominator: | ||||
Weighted-average shares outstanding, basic and diluted (in shares) | 1,148,973,077 | 781,482,459 | 1,052,940,583 | 777,938,599 |
Net loss per share attributable to BeiGene, Ltd., basic and diluted (in dollars per share) | $ (0.37) | $ (0.39) | $ (1.07) | $ (0.72) |
Share-Based Compensation Expe_3
Share-Based Compensation Expense - Share Options and Incentive Plan (Details) - USD ($) $ / shares in Units, $ in Thousands | Aug. 31, 2020 | Feb. 28, 2020 | Aug. 30, 2019 | Feb. 28, 2019 | Jun. 06, 2018 | Jun. 30, 2020 | Dec. 31, 2018 | Sep. 30, 2020 | Mar. 02, 2020 | Sep. 03, 2019 | Jan. 14, 2016 |
2016 Plan | |||||||||||
Share-based compensation | |||||||||||
Number of shares reserved and available for issuance (in shares) | 65,029,595 | ||||||||||
Automatic annual increase in shares reserved and available for issuance as a percentage to outstanding number of shares (as a percent) | 5.00% | ||||||||||
Increase in ordinary shares authorized (in shares) | 57,200,000 | 38,553,159 | |||||||||
2016 Plan | Share options | |||||||||||
Share-based compensation | |||||||||||
Granted (in shares) | 8,747,440 | ||||||||||
Number of options outstanding (in shares) | 75,861,996 | ||||||||||
2016 Plan | Restricted Share Units (RSUs) | |||||||||||
Share-based compensation | |||||||||||
Granted (in shares) | 17,185,597 | ||||||||||
Number of options outstanding (in shares) | 33,743,359 | ||||||||||
2011 Plan | |||||||||||
Share-based compensation | |||||||||||
Shares cancelled or forfeited (in shares) | 5,159,906 | ||||||||||
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) | 39,910 | ||||||||||
2018 Plan | Restricted Share Units (RSUs) | |||||||||||
Share-based compensation | |||||||||||
Number of options outstanding (in shares) | 1,706,692 | ||||||||||
ESPP | |||||||||||
Share-based compensation | |||||||||||
Number of shares reserved and available for issuance (in shares) | 3,500,000 | 7,355,315 | |||||||||
Increase in ordinary shares authorized (in shares) | 3,855,315 | ||||||||||
Discount on purchase price of common stock (as a percent) | 15.00% | ||||||||||
Maximum percentage of eligible earnings as after-tax withholdings to purchase ordinary shares (as a percent) | 10.00% | ||||||||||
Shares issued in period ( in shares) | 485,069 | 425,425 | 233,194 | 154,505 | |||||||
Proceeds from shares issued | $ 5,203 | $ 4,048 | $ 2,192 | $ 1,385 | |||||||
Share prices of ADS shares issues (in dollars per share) | $ 139.45 | $ 123.71 | $ 122.19 | $ 116.49 | |||||||
Exercise price of shares issues (in dollars per share) | $ 10.73 | $ 9.52 | 9.40 | 8.96 | |||||||
Share price, ADS (in dollars per share) | 143.75 | 137.05 | $ 164.06 | $ 145.54 | |||||||
Share price (in dollars per share) | $ 11.06 | $ 10.54 | $ 12.62 | $ 11.20 |
Share-Based Compensation Expe_4
Share-Based Compensation Expense - Expense Recognized (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based compensation | ||||
Compensation expense | $ 50,297 | $ 36,818 | $ 134,020 | $ 95,812 |
Research and development | ||||
Share-based compensation | ||||
Compensation expense | 25,410 | 20,674 | 69,521 | 54,599 |
Selling, general and administrative | ||||
Share-based compensation | ||||
Compensation expense | $ 24,887 | $ 16,144 | $ 64,499 | $ 41,213 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | |
Movement in accumulated other comprehensive loss | |||||||
Balance at the beginning of period | $ 2,546,492 | $ 2,827,056 | $ 978,355 | $ 1,571,264 | $ 1,622,679 | $ 1,753,647 | $ 978,355 |
Net-current period other comprehensive income | 9,099 | (2,738) | 1,349 | (14,930) | (6,436) | 4,440 | |
Balance at the end of period | 4,296,514 | 2,546,492 | 2,827,056 | 1,294,237 | 1,571,264 | 1,622,679 | 4,296,514 |
Accumulated Other Comprehensive Income | |||||||
Movement in accumulated other comprehensive loss | |||||||
Balance at the beginning of period | (9,299) | (6,548) | (8,001) | (225) | 6,072 | 1,526 | (8,001) |
Other comprehensive income before reclassifications | 9,132 | ||||||
Amounts reclassified from accumulated other comprehensive income | (1,550) | ||||||
Net-current period other comprehensive income | 8,880 | (2,751) | 1,453 | (14,605) | (6,297) | 4,546 | 7,582 |
Balance at the end of period | (419) | $ (9,299) | (6,548) | $ (14,830) | $ (225) | $ 6,072 | (419) |
Foreign Currency Translation Adjustments | |||||||
Movement in accumulated other comprehensive loss | |||||||
Balance at the beginning of period | (9,291) | (9,291) | |||||
Other comprehensive income before reclassifications | 7,398 | ||||||
Amounts reclassified from accumulated other comprehensive income | 0 | ||||||
Net-current period other comprehensive income | 7,398 | ||||||
Balance at the end of period | (1,893) | (1,893) | |||||
Unrealized Gain on available-for-Sale Securities | |||||||
Movement in accumulated other comprehensive loss | |||||||
Balance at the beginning of period | $ 1,290 | 1,290 | |||||
Other comprehensive income before reclassifications | 1,734 | ||||||
Amounts reclassified from accumulated other comprehensive income | (1,550) | ||||||
Net-current period other comprehensive income | 184 | ||||||
Balance at the end of period | $ 1,474 | $ 1,474 |
Shareholders_ Equity (Details)
Shareholders’ Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Jul. 15, 2020 | Jan. 02, 2020 | Sep. 30, 2020 | Jul. 10, 2020 | Dec. 31, 2019 |
Shareholders' equity | |||||
Ordinary shares, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | |||
Amgen, Inc | Beigene | |||||
Shareholders' equity | |||||
Minority interest in investment (as a percent) | 20.50% | ||||
Amgen, Inc | |||||
Shareholders' equity | |||||
Per share acquisition price (in dollars per share) | $ 174.85 | ||||
Proceeds from the issuance of stock | $ 2,779,241 | ||||
Shares issued (in shares) | 15,895,001 | ||||
Closed Registered Direct Offering | |||||
Shareholders' equity | |||||
Sale of stock shares received (in shares) | 145,838,979 | ||||
Ordinary shares, par value (in dollars per share) | $ 0.0001 | ||||
Per share acquisition price (in dollars per share) | 14.2308 | ||||
Sales price m ADS (in dollars per share) | $ 185 | $ 196.03 | |||
Sale of stock, consideration received on transaction | $ 2,075 | ||||
Proceeds from the issuance of stock | $ 2,069,610 |
Restricted Net Assets (Details)
Restricted Net Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Segment Reporting Information | ||
Minimum required statutory reserve of annual after-tax profit (as a percent) | 10.00% | |
Required statutory reserve as a percentage of registered capital (as a percent) | 50.00% | |
China | ||
Segment Reporting Information | ||
Restricted net assets | $ 158,737 | $ 109,633 |
Commitments and Contingencies -
Commitments and Contingencies - Commitments (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Jan. 02, 2020 |
Purchase and Capital commitments | ||
Purchase commitments | $ 142,858 | |
Minimum Purchase Commitments For Supply Purchased | ||
Purchase and Capital commitments | ||
Purchase commitments | 103,207 | |
Inventories | ||
Purchase and Capital commitments | ||
Purchase commitments | 39,651 | |
Capital Addition Purchase Commitments | ||
Purchase and Capital commitments | ||
Purchase commitments | 63,125 | |
Amgen, Inc | ||
Purchase and Capital commitments | ||
Maximum cash and development services commitment | $ 1,250,000 | |
Remaining portion of development funding | $ 1,077,206 |
Segment and geographic inform_3
Segment and geographic information - General Information (Details) | 9 Months Ended |
Sep. 30, 2020segment | |
Segment information | |
Number of operating segments | 1 |
Segment and geographic inform_4
Segment and geographic information - Tabular Disclosure (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Net product revenues by geographic area | ||||
Revenues | $ 91,080 | $ 50,141 | $ 208,774 | $ 371,320 |
PRC | ||||
Net product revenues by geographic area | ||||
Revenues | 85,384 | 50,141 | 199,301 | 165,704 |
United States | ||||
Net product revenues by geographic area | ||||
Revenues | 5,696 | 0 | 9,473 | 133,650 |
Other | ||||
Net product revenues by geographic area | ||||
Revenues | $ 0 | $ 0 | $ 0 | $ 71,966 |