Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2020 | Apr. 30, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 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 12(b) Security | American Depositary Shares, each representing 13 Ordinary Shares, par value $0.0001 per share | |
Trading Symbol | BGNE | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 1,008,198,947 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0001651308 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 1,957,101 | $ 618,011 |
Short-term restricted cash | 282 | 288 |
Short-term investments | 1,417,097 | 364,728 |
Accounts receivable, net | 65,620 | 70,878 |
Inventories | 28,775 | 28,553 |
Prepaid expenses and other current assets | 126,312 | 90,238 |
Total current assets | 3,595,187 | 1,172,696 |
Long-term restricted cash | 2,435 | 2,476 |
Property, plant and equipment, net | 240,331 | 242,402 |
Operating lease right-of-use assets | 91,509 | 82,520 |
Intangible assets, net | 5,563 | 5,846 |
Deferred tax assets | 37,937 | 37,894 |
Other non-current assets | 94,250 | 68,455 |
Total non-current assets | 472,025 | 439,593 |
Total assets | 4,067,212 | 1,612,289 |
Current liabilities: | ||
Accounts payable | 98,364 | 122,488 |
Accrued expenses and other payables | 179,331 | 163,556 |
Tax payable | 19,535 | 13,454 |
Operating lease liabilities, current portion | 14,597 | 10,814 |
Research and development cost share liability, current portion | 128,672 | 0 |
Short-term bank loan | 11,298 | 0 |
Total current liabilities | 451,797 | 310,312 |
Non-current liabilities: | ||
Long-term bank loan | 81,913 | 83,311 |
Shareholder loan | 157,278 | 157,384 |
Operating lease liabilities, non-current portion | 32,967 | 25,833 |
Deferred tax liabilities | 10,368 | 10,532 |
Research and development cost share liability, non-current portion | 460,528 | 0 |
Other long-term liabilities | 45,305 | 46,562 |
Total non-current liabilities | 788,359 | 323,622 |
Total liabilities | 1,240,156 | 633,934 |
Commitments and contingencies | ||
Equity: | ||
Ordinary shares, US$0.0001 par value per share; 9,500,000,000 shares authorized; 1,007,976,816 and 801,340,698 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively | 101 | 79 |
Additional paid-in capital | 5,138,239 | 2,925,970 |
Accumulated other comprehensive loss | (6,548) | (8,001) |
Accumulated deficit | (2,319,578) | (1,955,843) |
Total BeiGene, Ltd. shareholders’ equity | 2,812,214 | 962,205 |
Noncontrolling interest | 14,842 | 16,150 |
Total equity | 2,827,056 | 978,355 |
Total liabilities and equity | $ 4,067,212 | $ 1,612,289 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 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) | 1,007,976,816 | 801,340,698 |
Ordinary shares, shares outstanding (in shares) | 1,007,976,816 | 801,340,698 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Revenues | ||
Revenues | $ 52,059 | $ 77,833 |
Expenses | ||
Cost of sales - product | 14,149 | 15,261 |
Research and development | 304,302 | 178,351 |
Selling, general and administrative | 107,081 | 57,645 |
Amortization of intangible assets | 283 | 331 |
Total expenses | 425,815 | 251,588 |
Loss from operations | (373,756) | (173,755) |
Interest income, net | 6,690 | 4,477 |
Other income, net | 3,681 | 1,728 |
Loss before income taxes | (363,385) | (167,550) |
Income tax expense | 1,554 | 519 |
Net loss | (364,939) | (168,069) |
Less: net loss attributable to noncontrolling interests | (1,204) | (429) |
Net loss attributable to BeiGene, Ltd. | $ (363,735) | $ (167,640) |
Net loss per share attributable to BeiGene, Ltd., basic and diluted (in dollars per share) | $ (0.36) | $ (0.22) |
Weighted-average shares outstanding, basic and diluted (shares) | 1,005,347,581 | 774,750,255 |
Net loss per American Depositary Share (“ADS”), basic and diluted (in dollars per share) | $ (4.70) | $ (2.81) |
Weighted-average ADSs outstanding, basic and diluted (shares) | 77,334,429 | 59,596,173 |
Product revenue, net | ||
Revenues | ||
Revenues | $ 52,059 | $ 57,421 |
Collaboration revenue | ||
Revenues | ||
Revenues | $ 0 | $ 20,412 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||
Net loss | $ (364,939) | $ (168,069) |
Other comprehensive (loss)/ income, net of tax of nil: | ||
Foreign currency translation adjustments | (4,349) | 3,755 |
Unrealized holding gain, net | 5,698 | 685 |
Comprehensive loss | (363,590) | (163,629) |
Less: comprehensive loss attributable to noncontrolling interests | (1,308) | (535) |
Comprehensive loss attributable to BeiGene, Ltd. | $ (362,282) | $ (163,094) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS $ in Thousands | 3 Months Ended | |
Mar. 31, 2020USD ($) | Mar. 31, 2019USD ($) | |
Operating activities: | ||
Net loss | $ (364,939) | $ (168,069) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 7,750 | 3,416 |
Share-based compensation expenses | 38,255 | 26,392 |
Provision for doubtful accounts | 2,022 | 0 |
Unrealized gain on equity securities | (6,964) | 0 |
Acquired in-process research and development | 43,000 | 29,000 |
Amortization of research and development cost share liability | (27,634) | 0 |
Non-cash interest expense | 2,572 | 1,858 |
Deferred income tax benefits | (206) | (983) |
Other items, net | (1,105) | (3,218) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 3,236 | (17,920) |
Inventories | (222) | 3,102 |
Prepaid expenses and other current assets | (36,075) | (5,772) |
Operating lease right-of-use assets | (8,990) | (1,588) |
Other non-current assets | (2,710) | (10,212) |
Accounts payable | (21,450) | (20,364) |
Accrued expenses and other payables | 15,775 | (8,790) |
Tax payable | 6,080 | 969 |
Deferred revenue | 0 | (2,238) |
Operating lease liabilities | 10,917 | 1,550 |
Other long-term liabilities | (1,256) | 892 |
Net cash used in operating activities | (341,944) | (171,975) |
Investing activities: | ||
Purchases of property, plant and equipment | (21,533) | (21,828) |
Purchases of investments | (1,307,179) | (487,354) |
Proceeds from sale or maturity of investments | 256,743 | 710,598 |
Purchase of in-process research and development | (43,000) | (29,000) |
Net cash (used in) provided by investing activities | (1,114,969) | 172,416 |
Financing activities: | ||
Proceeds from sale of ordinary shares, net of cost | 2,162,407 | 0 |
Proceeds from research and development cost share liability | 616,834 | 0 |
Proceeds from long-term bank loan | 0 | 36,695 |
Proceeds from short-term bank loan | 11,298 | 0 |
Proceeds from option exercises and employee share purchase plan | 11,629 | 6,269 |
Net cash provided by financing activities | 2,802,168 | 42,964 |
Effect of foreign exchange rate changes, net | (6,212) | 4,265 |
Net increase in cash, cash equivalents, and restricted cash | 1,339,043 | 47,670 |
Cash, cash equivalents, and restricted cash at beginning of period | 620,775 | 740,713 |
Cash, cash equivalents, and restricted cash at end of period | 1,959,818 | 788,383 |
Supplemental cash flow information: | ||
Cash and cash equivalents | 1,957,101 | 764,492 |
Short-term restricted cash | 282 | 14,900 |
Long-term restricted cash | 2,435 | 8,991 |
Income taxes paid | 531 | 360 |
Interest paid | 1,136 | 888 |
Supplemental non-cash information: | ||
Acquisitions of equipment included in accounts payable | $ 26,412 | $ 32,462 |
Consolidated Statements Of Shar
Consolidated Statements Of Shareholders' Equity 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 (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 | 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, 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 (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 | 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 | 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 |
Description of Business, Basis
Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies | 3 Months Ended |
Mar. 31, 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 tislelizumab 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. As of May 1, 2020, the Company has filed three additional new or supplementary new drug applications ("sNDA") for regulatory approvals in China for its internally-developed products and is planning for launches in these additional products or indications in 2020 and beyond. The Company's in-licensed portfolio includes ABRAXANE ® , REVLIMID ® and VIDAZA ® , which it has been marketing in China since 2017 under a license from Celgene Logistics Sàrl, a Bristol Myers Squibb (“BMS”) company. The Company plans on launching additional in-licensed products in China from its collaborations, including XGEVA ® (denosumab), KYPROLIS ® (carfilzomib) and BLINCYTO ® (blinatumomab) from Amgen Inc. ("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 March 31, 2020 , the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2020 and 2019 , the condensed consolidated statements of cash flows for the three months ended March 31, 2020 and 2019 , and the condensed consolidated statements of shareholders' equity for the three months ended March 31, 2020 and 2019 , and the related footnote disclosures are unaudited. The accompanying unaudited interim 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 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 months ended March 31, 2020 are not necessarily indicative of the results expected for the full fiscal year or for any future annual or interim period. The 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") and MapKure, LLC, under the voting model and recognizes the minority shareholders' equity interest as a noncontrolling interest in its condensed consolidated financial statements. Use of estimates The preparation of the 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, 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 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 three months ended March 31, 2020 , as compared to the significant accounting policies described in the Annual Report. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 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 March 31, 2020 and December 31, 2019 : Quoted Price in Active Significant Market for Other Significant Identical Observable Unobservable Assets Inputs Inputs As of March 31, 2020 (Level 1) (Level 2) (Level 3) $ $ $ Short-term investments (Note 4): U.S. treasury securities 1,417,097 — — Cash equivalents: U.S. treasury securities 251,505 — — Money market funds 1,144,458 — — Other non-current assets: Equity securities (Note 4) 7,592 4,372 — Total 2,820,652 4,372 — 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 strategic 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. The Company had no liabilities measured and recorded at fair value on a recurring basis as of March 31, 2020 or December 31, 2019 |
Collaborative Arrangements
Collaborative Arrangements | 3 Months Ended |
Mar. 31, 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 or seven years. Amgen is responsible for manufacturing of the products globally and will supply the products to the Company at an agreed upon price. The Company and Amgen will share equally in the China commercial profits and losses during the commercialization period. Following the commercialization period, the Company has the right to retain one product and is entitled to receive royalties on sales in China for an additional five years on the products not retained. XGEVA 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. Additionally, new drug applications have been filed in China for KYPROLIS as a treatment for patients with multiple myeloma and BLINCYTO a 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. In April 2020, two Amgen oncology pipeline assets were removed from the collaboration due to portfolio prioritization, and the parties expect that the development plan for the assets in the portfolio will continue to evolve over time. 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 AMG 510, 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 AMG 510). 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 collaboration, 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. 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 three months ended March 31, 2020 were as follows: Three Months Ended March 31, 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 months ended March 31, 2020 were as follows: Three Months Ended March 31, 2020 $ Research and development expense 28,366 Amortization of research and development cost share liability 27,634 Total amount due to Amgen for BeiGene's portion of the development funding 56,000 Total amount of development funding payable in cash 56,000 Total amount of development funding paid with development services — Remaining portion of development funding cap at March 31, 2020 1,194,000 At March 31, 2020 , the research and development cost share liability recorded in the Company's balance sheet was as follows: As of March 31, 2020 $ Research and development cost share liability, current portion 128,672 Research and development cost share liability, non-current portion 460,528 Total research and development cost share liability 589,200 There were no product sales or commercial profit share payments related to the Amgen collaboration during the three months ended March 31, 2020 . Celgene Corporation, a Bristol Myers Squibb company ("BMS") On July 5, 2017, the Company entered into a license agreement with Celgene Corporation, now BMS, 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 months ended March 31, 2020 and 2019 : Three Months Ended March 31, 2020 2019 $ $ Reimbursement of research and development costs — 18,174 Research and development service revenue — 2,238 Total — 20,412 For the three months ended March 31, 2019 , the Company recognized collaboration revenue of $20,412 related to its former collaboration with BMS. The Company recognized $18,174 of research and development reimbursement revenue for the three months ended March 31, 2019 for the clinical trials that Celgene had opted into. The $2,238 of research and development services revenue for the three months ended March 31, 2019 , 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. 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 months ended March 31, 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 March 31, 2020 2019 Research and development payments to Collaboration Partners $ $ Upfront payments 43,000 10,000 Milestone payments 5,000 — Total 48,000 10,000 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 three months ended March 31, 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 three months ended March 31, 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 | 3 Months Ended |
Mar. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Restricted Cash and Investments | Restricted Cash and Investments Restricted Cash The Company’s restricted cash balance of $2,717 as of March 31, 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 March 31, 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 1,410,129 6,968 — 1,417,097 Total 1,410,129 6,968 — 1,417,097 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 March 31, 2020 |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories The Company’s inventory balance consisted of the following: As of March 31, December 31, 2020 2019 $ $ Work in process 444 — Finished goods 28,331 28,553 Total inventories 28,775 28,553 |
Property, plant and equipment
Property, plant and equipment | 3 Months Ended |
Mar. 31, 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 March 31, December 31, 2020 2019 $ $ Laboratory equipment 49,059 47,154 Leasehold improvements 23,866 24,008 Building 107,992 109,514 Manufacturing equipment 65,123 62,775 Software, electronics and office equipment 14,688 14,705 Property, plant and equipment, at cost 260,728 258,156 Less accumulated depreciation (43,375 ) (36,709 ) Construction in progress 22,978 20,955 Property, plant and equipment, net 240,331 242,402 As of March 31, 2020 and December 31, 2019 , construction in progress ("CIP") of $22,978 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 months ended March 31, 2020 and 2019 was $7,467 and $3,085 , respectively. |
Guangzhou Biologics Business
Guangzhou Biologics Business | 3 Months Ended |
Mar. 31, 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 (Hong Kong) Co., Limited ("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 RMB 200,000 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 RMB 100,000 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 RMB 900,000 loan (the “Shareholder Loan”) to BeiGene Biologics (see Note 12). 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 RMB 137,830 and RMB 2,415 , 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 RMB 100,000 into BeiGene Biologics, and BeiGene Biologics drew down the Shareholder Loan of RMB 900,000 from GET (as further described in Note 12). 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 March 31, 2020 , the Company and GET held 95% and 5% equity interests in BeiGene Biologics, respectively. As of March 31, 2020 , the Company had $83,126 of cash and cash equivalents and $1,961 of restricted cash held by BeiGene Biologics to be used to build the commercial-scale biologics facility and to fund research and development of the Company's biologics drug candidates in China. Commercial distribution legal entity structure BeiGene (Guangzhou) Co., Ltd. (“BGC”), a wholly-owned subsidiary of BeiGene HK, was organized on July 11, 2017. In September 2018, BGC 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 | 3 Months Ended |
Mar. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible Assets Intangible assets as of March 31, 2020 and December 31, 2019 are summarized as follows: As of March 31, 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 (1,937 ) 5,563 7,500 (1,750 ) 5,750 Trading license 816 (816 ) — 816 (720 ) 96 Total finite-lived intangible assets 8,316 (2,753 ) 5,563 8,316 (2,470 ) 5,846 Product distribution rights consist of distribution rights on the approved cancer therapies licensed from BMS, ABRAXANE, REVLIMID, and VIDAZA 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. Amortization expense of intangible assets for the three months ended March 31, 2020 and 2019 was $283 and $331 , respectively. As of March 31, 2020 , expected amortization expense for the unamortized finite-lived intangible assets is approximately $563 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 | 3 Months Ended |
Mar. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Income tax expense was $1,554 and $519 , respectively, for the three months ended March 31, 2020 and 2019. The income tax expense for the three months ended March 31, 2020 was primarily attributable to income reported in certain China subsidiaries as adjusted for certain non-deductible expenses offset by the tax benefit of deferred U.S. stock-based compensation deductions. The resulting current U.S. tax was reduced by windfall stock compensation deductions, research and development tax credits and other special tax deductions. The income tax expense for the three months ended March 31, 2019 was primarily attributable to income reported in the U.S. and certain China subsidiaries offset by U.S. research and development tax credits and other special tax deductions. 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 increase to the Company's income tax receivable of $5,586 as of March 31, 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 March 31, 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 March 31, 2020 , the Company had gross unrecognized tax benefits of $5,003 . 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 $369 in the three months ended March 31, 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 March 31, 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 March 31, 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 | 3 Months Ended |
Mar. 31, 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 three months ended March 31, 2020 consists of the following activity: Allowance for Credit Losses $ Balance as of December 31, 2019 — Current period provision for expected credit losses 2,022 Amounts written-off — Recoveries of amounts previously written-off — Balance as of March 31, 2020 2,022 Prepaid expenses and other current assets consist of the following: As of March 31, December 31, 2020 2019 $ $ Prepaid research and development costs 75,867 69,715 Prepaid taxes 17,392 9,498 Other receivables 6,414 — Interest receivable 5,941 1,932 Prepaid insurance 4,298 — Prepaid manufacturing costs 3,525 — Other 12,875 9,093 Total 126,312 90,238 Other non-current assets consist of the following: As of March 31, December 31, 2020 2019 $ $ Goodwill 109 109 Prepayment of property and equipment 20,421 10,289 Prepayment of facility capacity expansion activities (1) 25,963 24,881 Prepaid VAT 32,396 29,967 Rental deposits and other 3,397 3,209 Long-term investment (Note 4) 11,964 — Total 94,250 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 as further described in Note 7. Accrued expenses and other payables consist of the following: As of March 31, December 31, 2020 2019 $ $ Compensation related 27,272 54,156 External research and development activities related 53,428 62,794 Development funding payable- Amgen 56,000 — Commercial activities 18,522 25,645 Income tax and other taxes 11,944 9,648 Sales rebates and returns related 4,014 3,198 Professional fees and other 8,151 8,115 Total 179,331 163,556 Other long-term liabilities consist of the following: As of March 31, December 31, 2020 2019 $ $ Deferred government grant income 45,134 46,391 Other 171 171 Total 45,305 46,562 |
Bank Loans
Bank Loans | 3 Months Ended |
Mar. 31, 2020 | |
Debt Disclosure [Abstract] | |
Bank Loans | 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 RMB 580,000 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. Interest expense is paid quarterly until the loan is fully settled. As of March 31, 2020 , the Company has fully drawn down $81,913 (RMB 580,000 ) of the loan. The loan interest rate was 4.9% for the three months ended March 31, 2020 , and the maturity dates range from 2021 to 2027. On January 13, 2020, BeiGene Shanghai entered into a one -year loan agreement with China Industrial Bank to borrow up to RMB 200,000 at a fixed interest rate of 5.6% . On January 19, 2020, the Company borrowed RMB 80,000 of the loan. Interest will be paid quarterly until the loan becomes fully due on January 18, 2021. As of March 31, 2020 the amount outstanding under the loan agreement was $11,298 . Interest expense recognized for the three months ended March 31, 2020 and 2019 was $1,719 and $941 , respectively, among which, $66 and $641 was capitalized, respectively. |
Shareholder Loan
Shareholder Loan | 3 Months Ended |
Mar. 31, 2020 | |
Related Party Transactions [Abstract] | |
Shareholder Loan | Shareholder Loan On March 7, 2017, BeiGene Biologics entered into the Shareholder Loan Contract with GET, pursuant to which GET agreed to provide a Shareholder Loan of RMB 900,000 to BeiGene Biologics. The Shareholder Loan has a conversion feature, 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 RMB 900,000 from GET. Key features of the Shareholder Loan The Shareholder Loan bears simple interest at a fixed rate of 8% per annum. No interest payment is due or payable prior to the repayment of the principal or the debt-to-equity conversion. The term of the Shareholder Loan is 72 months , commencing from the actual drawdown date of April 14, 2017 and ending on April 13, 2023, unless converted earlier. The Shareholder Loan may be repaid or converted, either partially or in full, into an additional mid-single digit percentage equity interest in BeiGene Biologics prior to its maturity date, pursuant to the terms of the JV Agreement. BeiGene Biologics has the right to make early repayment at any time; provided, however, that if repayment is to occur before the debt-to-equity conversion it would require written approval of both BeiGene Biologics and GET. Upon conversion of the Shareholder Loan, GET will receive an additional equity interest in BeiGene Biologics, which will be based on the formula outlined in the JV Agreement. The Shareholder Loan can only be used for BeiGene Biologics, including the construction and operation of the biologics manufacturing facility and research and development and clinical trials to be carried out by BeiGene Biologics. If BeiGene Biologics does not use the Shareholder Loan proceeds for the specified purposes, GET may be entitled to certain liquidated damages. In the event of an early termination of the JV Agreement, the Shareholder Loan will become due and payable at the time of termination of the JV Agreement. Accounting for the Shareholder Loan The Shareholder Loan is classified as a long-term liability and initially measured at the principal of RMB 900,000 . Interest is accrued based on the interest rate of 8% per annum. As the Shareholder Loan may be share-settled by a number of shares with a fair value equal to a fixed settlement amount, the settlement is not viewed as a conversion feature, but as a redemption feature because the settlement amount does not vary with the share price. This in-substance redemption feature does not require bifurcation because it is clearly and closely related to the debt host that does not involve a substantial premium or discount. Since there is no conversion feature embedded in the Shareholder Loan, no beneficial conversion feature was recorded. There are no other embedded derivatives that are required to be bifurcated. The portion of interest accrued on the Shareholder Loan related to borrowings used to construct the BeiGene factory in Guangzhou is being capitalized in accordance with ASC 835-20, Interest – Capitalization of Interest. For the three months ended March 31, 2020 and 2019, total interest generated from the Shareholder Loan was $2,572 and $2,645 , respectively, of which, $0 and $788 was capitalized, respectively. |
Product Revenue
Product Revenue | 3 Months Ended |
Mar. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Product Revenue | Product Revenue The Company’s product sales are derived from the sale of its internally-developed products BRUKINSA in the U.S. and tislelizumab in China, as well as the sale of ABRAXANE, REVLIMID, and VIDAZA in China under a distribution license from BMS. The table below presents the Company’s net product sales for the three months ended March 31, 2020 and 2019 . Three Months Ended March 31, 2020 2019 $ $ Product revenue – gross 53,188 58,536 Less: Rebates and sales returns (1,129 ) (1,115 ) Product revenue – net 52,059 57,421 The following table disaggregates net product sales by product for the three months ended March 31, 2020 and March 31, 2019 : Three Months Ended March 31, 2020 2019 $ $ Tislelizumab 20,526 — BRUKINSA ™ 717 — ABRAXANE ® 17,145 27,134 REVLIMID ® 7,628 23,584 VIDAZA ® 6,043 6,703 Total net product revenue 52,059 57,421 The following table presents the roll-forward of accrued sales rebates and returns for the three months ended March 31, 2020 and March 31, 2019 : Sales Rebates and Returns $ Balance as of December 31, 2019 4,749 Accrual 1,115 Payments (2,498 ) Balance as of March 31, 2019 3,366 Balance as of December 31, 2019 3,198 Accrual 1,129 Payments (313 ) Balance as of March 31, 2020 4,014 |
Loss Per Share
Loss Per Share | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Loss Per Share | Loss Per Share Loss per share was calculated as follows: Three Months Ended March 31, 2020 2019 $ $ Numerator: Net loss attributable to BeiGene, Ltd. (363,735 ) (167,640 ) Denominator: Weighted average shares outstanding, basic and diluted 1,005,347,581 774,750,255 Net loss per share attributable to BeiGene, Ltd., basic and diluted (0.36 ) (0.22 ) 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 months ended March 31, 2020 and 2019 . |
Share-Based Compensation Expens
Share-Based Compensation Expense | 3 Months Ended |
Mar. 31, 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 March 31, 2020 , ordinary shares cancelled or forfeited under the 2011 Plan that were carried over to the 2016 Plan totaled 5,152,236 . 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 HKEx rules. In December 2018, the board of directors 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. 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 three months ended March 31, 2020 , the Company granted options for 462,449 ordinary shares and restricted share units for 1,880,554 ordinary shares under the 2016 Plan. As of March 31, 2020 , options and restricted share units for ordinary shares outstanding under the 2016 Plan totaled 90,600,885 and 25,109,448 , 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 HKEx rules. During the three months ended March 31, 2020 , the Company did not grant any options or restricted share units under the 2018 Plan. As of March 31, 2020 , options and restricted share units for ordinary shares outstanding under the 2018 Plan totaled 79,404 and 2,228,174 , 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 HKEx rules. 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 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 February 28, 2020 of $158.35 per ADS, or $12.18 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 months ended March 31, 2020 and 2019 : Three Months Ended March 31, 2020 2019 $ $ Research and development 20,399 15,771 Selling, general and administrative 17,856 10,621 Total 38,255 26,392 |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income | 3 Months Ended |
Mar. 31, 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 (loss)/ income before reclassifications (4,245 ) 6,938 2,693 Amounts reclassified from accumulated other comprehensive income — (1,240 ) (1,240 ) Net-current period other comprehensive (loss)/ income (4,245 ) 5,698 1,453 Balance as of March 31, 2020 (13,536 ) 6,988 (6,548 ) |
Shareholders_ Equity
Shareholders’ Equity | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Shareholders’ Equity | Shareholders’ Equity 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 | 3 Months Ended |
Mar. 31, 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. During the three months ended March 31, 2020 and 2019 , no appropriation to statutory reserves was made because the PRC subsidiaries had substantial losses during these periods. 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 March 31, 2020 and December 31, 2019 , amounts restricted were the net assets of the Company’s PRC subsidiaries, which amounted to $102,494 and $109,633 , respectively. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Purchase Commitments As of March 31, 2020 , the Company had purchase commitments amounting to $117,325 , of which $96,686 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $20,639 related to binding purchase obligations of inventory from BMS. The Company does not have any minimum purchase requirements for inventory from BMS. Capital commitments The Company had capital commitments amounting to $60,645 for the acquisition of property, plant and equipment as of March 31, 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 March 31, 2020, the Company's remaining co-development funding commitment was $1,194,000 . 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 | 3 Months Ended |
Mar. 31, 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 March 31, 2020 2019 $ $ PRC 51,342 57,421 United States 717 13,268 Other — 7,144 Total 52,059 77,833 |
Subsequent Event
Subsequent Event | 3 Months Ended |
Mar. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent Event On April 13, 2020, the Company's board of directors adopted an amendment to the 2016 Plan to increase the number of authorized shares by 57,200,000 ordinary shares and to extend the term of the plan through April 13, 2030, subject to approval of the Company's shareholders at the annual meeting to be held on June 17, 2020. |
Description of Business, Basi_2
Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 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 March 31, 2020 , the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2020 and 2019 , the condensed consolidated statements of cash flows for the three months ended March 31, 2020 and 2019 , and the condensed consolidated statements of shareholders' equity for the three months ended March 31, 2020 and 2019 , and the related footnote disclosures are unaudited. The accompanying unaudited interim 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 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 months ended March 31, 2020 are not necessarily indicative of the results expected for the full fiscal year or for any future annual or interim period. The 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") and MapKure, LLC, under the voting model and recognizes the minority shareholders' equity interest as a noncontrolling interest in its condensed consolidated financial statements. |
Use of estimates | Use of estimates The preparation of the 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, 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 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 three months ended March 31, 2020 , as compared to the significant accounting policies described in the Annual Report. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, 2020 and December 31, 2019 : Quoted Price in Active Significant Market for Other Significant Identical Observable Unobservable Assets Inputs Inputs As of March 31, 2020 (Level 1) (Level 2) (Level 3) $ $ $ Short-term investments (Note 4): U.S. treasury securities 1,417,097 — — Cash equivalents: U.S. treasury securities 251,505 — — Money market funds 1,144,458 — — Other non-current assets: Equity securities (Note 4) 7,592 4,372 — Total 2,820,652 4,372 — 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) | 3 Months Ended |
Mar. 31, 2020 | |
Research and Development [Abstract] | |
Collaboration Agreements | Amounts recorded related to the cash proceeds received from the Amgen collaboration for the three months ended March 31, 2020 were as follows: Three Months Ended March 31, 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 months ended March 31, 2020 were as follows: Three Months Ended March 31, 2020 $ Research and development expense 28,366 Amortization of research and development cost share liability 27,634 Total amount due to Amgen for BeiGene's portion of the development funding 56,000 Total amount of development funding payable in cash 56,000 Total amount of development funding paid with development services — Remaining portion of development funding cap at March 31, 2020 1,194,000 At March 31, 2020 , the research and development cost share liability recorded in the Company's balance sheet was as follows: As of March 31, 2020 $ Research and development cost share liability, current portion 128,672 Research and development cost share liability, non-current portion 460,528 Total research and development cost share liability 589,200 |
Schedule of total collaboration revenue recognized | The following table summarizes total collaboration revenue recognized related to the BMS collaboration for the three months ended March 31, 2020 and 2019 : Three Months Ended March 31, 2020 2019 $ $ Reimbursement of research and development costs — 18,174 Research and development service revenue — 2,238 Total — 20,412 Three Months Ended March 31, 2020 2019 Research and development payments to Collaboration Partners $ $ Upfront payments 43,000 10,000 Milestone payments 5,000 — Total 48,000 10,000 three months ended March 31, 2020 and 2019 . Three Months Ended March 31, 2020 2019 $ $ Product revenue – gross 53,188 58,536 Less: Rebates and sales returns (1,129 ) (1,115 ) Product revenue – net 52,059 57,421 The following table disaggregates net product sales by product for the three months ended March 31, 2020 and March 31, 2019 : Three Months Ended March 31, 2020 2019 $ $ Tislelizumab 20,526 — BRUKINSA ™ 717 — ABRAXANE ® 17,145 27,134 REVLIMID ® 7,628 23,584 VIDAZA ® 6,043 6,703 Total net product revenue 52,059 57,421 |
Restricted Cash and Investmen_2
Restricted Cash and Investments (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of short-term investments | Short-term investments as of March 31, 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 1,410,129 6,968 — 1,417,097 Total 1,410,129 6,968 — 1,417,097 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 x (Tables)
Inventories x (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | The Company’s inventory balance consisted of the following: As of March 31, December 31, 2020 2019 $ $ Work in process 444 — Finished goods 28,331 28,553 Total inventories 28,775 28,553 |
Property, plant and equipment (
Property, plant and equipment (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, December 31, 2020 2019 $ $ Laboratory equipment 49,059 47,154 Leasehold improvements 23,866 24,008 Building 107,992 109,514 Manufacturing equipment 65,123 62,775 Software, electronics and office equipment 14,688 14,705 Property, plant and equipment, at cost 260,728 258,156 Less accumulated depreciation (43,375 ) (36,709 ) Construction in progress 22,978 20,955 Property, plant and equipment, net 240,331 242,402 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible assets outstanding | Intangible assets as of March 31, 2020 and December 31, 2019 are summarized as follows: As of March 31, 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 (1,937 ) 5,563 7,500 (1,750 ) 5,750 Trading license 816 (816 ) — 816 (720 ) 96 Total finite-lived intangible assets 8,316 (2,753 ) 5,563 8,316 (2,470 ) 5,846 |
Supplemental Balance Sheet In_2
Supplemental Balance Sheet Information (Tables) | 3 Months Ended |
Mar. 31, 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 three months ended March 31, 2020 consists of the following activity: Allowance for Credit Losses $ Balance as of December 31, 2019 — Current period provision for expected credit losses 2,022 Amounts written-off — Recoveries of amounts previously written-off — Balance as of March 31, 2020 2,022 |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets consist of the following: As of March 31, December 31, 2020 2019 $ $ Prepaid research and development costs 75,867 69,715 Prepaid taxes 17,392 9,498 Other receivables 6,414 — Interest receivable 5,941 1,932 Prepaid insurance 4,298 — Prepaid manufacturing costs 3,525 — Other 12,875 9,093 Total 126,312 90,238 |
Schedule of other non-current assets | Other non-current assets consist of the following: As of March 31, December 31, 2020 2019 $ $ Goodwill 109 109 Prepayment of property and equipment 20,421 10,289 Prepayment of facility capacity expansion activities (1) 25,963 24,881 Prepaid VAT 32,396 29,967 Rental deposits and other 3,397 3,209 Long-term investment (Note 4) 11,964 — Total 94,250 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 as further described in Note 7. |
Schedule of accrued expenses and other payables | Accrued expenses and other payables consist of the following: As of March 31, December 31, 2020 2019 $ $ Compensation related 27,272 54,156 External research and development activities related 53,428 62,794 Development funding payable- Amgen 56,000 — Commercial activities 18,522 25,645 Income tax and other taxes 11,944 9,648 Sales rebates and returns related 4,014 3,198 Professional fees and other 8,151 8,115 Total 179,331 163,556 |
Schedule of other long-term liabilities | Other long-term liabilities consist of the following: As of March 31, December 31, 2020 2019 $ $ Deferred government grant income 45,134 46,391 Other 171 171 Total 45,305 46,562 |
Product Revenue (Tables)
Product Revenue (Tables) | 3 Months Ended |
Mar. 31, 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 months ended March 31, 2020 and 2019 : Three Months Ended March 31, 2020 2019 $ $ Reimbursement of research and development costs — 18,174 Research and development service revenue — 2,238 Total — 20,412 Three Months Ended March 31, 2020 2019 Research and development payments to Collaboration Partners $ $ Upfront payments 43,000 10,000 Milestone payments 5,000 — Total 48,000 10,000 three months ended March 31, 2020 and 2019 . Three Months Ended March 31, 2020 2019 $ $ Product revenue – gross 53,188 58,536 Less: Rebates and sales returns (1,129 ) (1,115 ) Product revenue – net 52,059 57,421 The following table disaggregates net product sales by product for the three months ended March 31, 2020 and March 31, 2019 : Three Months Ended March 31, 2020 2019 $ $ Tislelizumab 20,526 — BRUKINSA ™ 717 — ABRAXANE ® 17,145 27,134 REVLIMID ® 7,628 23,584 VIDAZA ® 6,043 6,703 Total net product revenue 52,059 57,421 |
Schedule of accrued sales rebates and returns | The following table presents the roll-forward of accrued sales rebates and returns for the three months ended March 31, 2020 and March 31, 2019 : Sales Rebates and Returns $ Balance as of December 31, 2019 4,749 Accrual 1,115 Payments (2,498 ) Balance as of March 31, 2019 3,366 Balance as of December 31, 2019 3,198 Accrual 1,129 Payments (313 ) Balance as of March 31, 2020 4,014 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, 2020 2019 $ $ Numerator: Net loss attributable to BeiGene, Ltd. (363,735 ) (167,640 ) Denominator: Weighted average shares outstanding, basic and diluted 1,005,347,581 774,750,255 Net loss per share attributable to BeiGene, Ltd., basic and diluted (0.36 ) (0.22 ) |
Share-Based Compensation Expe_2
Share-Based Compensation Expense (Tables) | 3 Months Ended |
Mar. 31, 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 months ended March 31, 2020 and 2019 : Three Months Ended March 31, 2020 2019 $ $ Research and development 20,399 15,771 Selling, general and administrative 17,856 10,621 Total 38,255 26,392 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Tables) | 3 Months Ended |
Mar. 31, 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 (loss)/ income before reclassifications (4,245 ) 6,938 2,693 Amounts reclassified from accumulated other comprehensive income — (1,240 ) (1,240 ) Net-current period other comprehensive (loss)/ income (4,245 ) 5,698 1,453 Balance as of March 31, 2020 (13,536 ) 6,988 (6,548 ) |
Segment and geographic inform_2
Segment and geographic information (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Segment Reporting [Abstract] | |
Schedule of net product revenues by geographic area | : Three Months Ended March 31, 2020 2019 $ $ PRC 51,342 57,421 United States 717 13,268 Other — 7,144 Total 52,059 77,833 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 |
Assets: | ||
Short-term investments | $ 1,417,097,000 | $ 364,728,000 |
U.S. treasury securities | ||
Assets: | ||
Short-term investments | 1,417,097,000 | 364,728,000 |
Recurring basis | ||
Liabilities: | ||
Liabilities measured and recorded at fair value | 0 | 0 |
Recurring basis | (Level 1) | ||
Assets: | ||
Equity securities (Note 4) | 7,592,000 | |
Total | 2,820,652,000 | 431,631,000 |
Recurring basis | (Level 1) | Money market funds | ||
Assets: | ||
Cash equivalents: | 1,144,458,000 | 50,461,000 |
Recurring basis | (Level 1) | U.S. treasury securities | ||
Assets: | ||
Short-term investments | 1,417,097,000 | 364,728,000 |
Cash equivalents: | 251,505,000 | 16,442,000 |
Recurring basis | (Level 2) | ||
Assets: | ||
Equity securities (Note 4) | 4,372,000 | |
Total | 4,372,000 | 0 |
Recurring basis | (Level 2) | Money market funds | ||
Assets: | ||
Cash equivalents: | 0 | 0 |
Recurring basis | (Level 2) | U.S. treasury securities | ||
Assets: | ||
Short-term investments | 0 | 0 |
Cash equivalents: | 0 | 0 |
Recurring basis | (Level 3) | ||
Assets: | ||
Equity securities (Note 4) | 0 | |
Total | 0 | 0 |
Recurring basis | (Level 3) | Money market funds | ||
Assets: | ||
Cash equivalents: | 0 | 0 |
Recurring basis | (Level 3) | U.S. treasury securities | ||
Assets: | ||
Short-term investments | 0 | 0 |
Cash equivalents: | $ 0 | $ 0 |
Collaborative Arrangements - Am
Collaborative Arrangements - Amgen (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 02, 2020 | Mar. 31, 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 (usd per share) | $ 174.85 | |
Payments to acquire equity interest | $ 2,779,241 | |
Fair value of equity issued to Amgen | $ 2,162,407 | |
Fair value of research and development cost share liability | $ 601,857 | $ 616,834 |
Collaborative Arrangements - De
Collaborative Arrangements - Details of Proceeds From Transaction (Details) - Amgen, Inc - USD ($) $ in Thousands | Jan. 02, 2020 | Mar. 31, 2020 |
Research and Development Arrangement, Contract to Perform for Others | ||
Fair value of equity issued to Amgen | $ 2,162,407 | |
Fair value of research and development cost share liability | $ 601,857 | 616,834 |
Payments to Acquire Businesses, Net of Cash Acquired | $ 2,779,241 |
Collaborative Arrangements - Fu
Collaborative Arrangements - Funding Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Research and Development Arrangement, Contract to Perform for Others | |||
Research and development expense | $ 304,302 | $ 178,351 | |
Total amount of development funding payable in cash | 56,000 | $ 0 | |
Amgen, Inc | |||
Research and Development Arrangement, Contract to Perform for Others | |||
Research and development expense | 28,366 | ||
Amortization of research and development cost share liability | 27,634 | ||
Total amount due to Amgen for BeiGene's portion of the development funding | 56,000 | ||
Total amount of development funding payable in cash | 56,000 | ||
Total amount of development funding paid with development services | 0 | ||
Remaining portion of development funding cap at March 31, 2020 | $ 1,194,000 |
Collaborative Arrangements - Fi
Collaborative Arrangements - Financing Liability (Details) - Amgen, Inc $ in Thousands | Mar. 31, 2020USD ($) |
Research and Development Arrangement, Contract to Perform for Others | |
Research and development cost share liability, current portion | $ 128,672 |
Research and development cost share liability, non-current portion | 460,528 |
Total research and development cost share liability | $ 589,200 |
Collaborative Arrangements - Co
Collaborative Arrangements - Collaboration Revenue Recognized (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Revenues | ||
Revenues | $ 52,059 | $ 77,833 |
Collaboration | ||
Revenues | ||
Revenues | 0 | 20,412 |
Reimbursement of research and development costs | ||
Revenues | ||
Revenues | 0 | 18,174 |
Research and development service revenue | ||
Revenues | ||
Revenues | $ 0 | $ 2,238 |
Collaborative Arrangements - _2
Collaborative Arrangements - Collaboration Revenue Recognized Narratives (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Research and Development Arrangement, Contract to Perform for Others | ||
Revenues | $ 52,059 | $ 77,833 |
Collaboration revenue | ||
Research and Development Arrangement, Contract to Perform for Others | ||
Revenues | 0 | 20,412 |
Reimbursement of research and development costs | ||
Research and Development Arrangement, Contract to Perform for Others | ||
Revenues | 0 | 18,174 |
Research and development service revenue | ||
Research and Development Arrangement, Contract to Perform for Others | ||
Revenues | $ 0 | 2,238 |
Deferred revenue recognized | $ 2,238 |
Collaborative Arrangements - In
Collaborative Arrangements - In Licensing Agreements (Details) - USD ($) $ in Thousands | Feb. 13, 2020 | Mar. 31, 2020 | Mar. 31, 2019 |
Research and Development Arrangement, Contract to Perform for Others | |||
Upfront payments | $ 40,000 | $ 43,000 | $ 10,000 |
Milestone payments | 5,000 | 0 | |
Total | 48,000 | $ 10,000 | |
EUSA Pharma | |||
Research and Development Arrangement, Contract to Perform for Others | |||
Maximum milestone payments | $ 160,000 |
Restricted Cash and Investmen_3
Restricted Cash and Investments - Restricted Cash (Details) $ in Thousands | Mar. 31, 2020USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Restricted cash | $ 2,717 |
Restricted Cash and Investmen_4
Restricted Cash and Investments - Tabular Disclosure (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Short-term investments | ||
Available-for-sale securities, amortized cost | $ 1,410,129 | $ 363,440 |
Available-for-sale securities, gross unrealized gains | 6,968 | 1,288 |
Available-for-sale securities. gross unrealized losses | 0 | 0 |
Short-term investments | 1,417,097 | 364,728 |
U.S. treasury securities | ||
Short-term investments | ||
Available-for-sale securities, amortized cost | 1,410,129 | 363,440 |
Available-for-sale securities, gross unrealized gains | 6,968 | 1,288 |
Available-for-sale securities. gross unrealized losses | 0 | 0 |
Short-term investments | $ 1,417,097 | $ 364,728 |
Restricted Cash and Investmen_5
Restricted Cash and Investments - Equity Method Investment (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |
Jan. 31, 2020 | Mar. 31, 2020 | Mar. 31, 2019 | |
Schedule of Investments | |||
Purchases of investments | $ 1,307,179 | $ 487,354 | |
Gains from equity investments | 6,964 | $ 0 | |
Leap Therapeutic, Inc | |||
Schedule of Investments | |||
Equity method investments (percent) | 13.40% | ||
Equity method investments, including warrants (percent) | 23.70% | ||
Gains from equity investments | 6,964 | ||
Leap Therapeutic, Inc | Series B preferred stock | |||
Schedule of Investments | |||
Purchases of investments | $ 5,000 | ||
Warrants | 4,372 | ||
Leap Therapeutic, Inc | Common Stock | |||
Schedule of Investments | |||
Equity investment | $ 7,592 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Work in process | $ 444 | $ 0 |
Finished goods | 28,331 | 28,553 |
Inventories | $ 28,775 | $ 28,553 |
Property, plant and equipment -
Property, plant and equipment - Tabular Disclosure (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Property and equipment | ||
Property, plant and equipment, at cost | $ 260,728 | $ 258,156 |
Less accumulated depreciation | (43,375) | (36,709) |
Property, plant and equipment, net | 240,331 | 242,402 |
Laboratory equipment | ||
Property and equipment | ||
Property, plant and equipment, at cost | 49,059 | 47,154 |
Leasehold improvements | ||
Property and equipment | ||
Property, plant and equipment, at cost | 23,866 | 24,008 |
Building | ||
Property and equipment | ||
Property, plant and equipment, at cost | 107,992 | 109,514 |
Manufacturing equipment | ||
Property and equipment | ||
Property, plant and equipment, at cost | 65,123 | 62,775 |
Software, electronics and office equipment | ||
Property and equipment | ||
Property, plant and equipment, at cost | 14,688 | 14,705 |
Construction in progress | ||
Property and equipment | ||
Property, plant and equipment, at cost | $ 22,978 | $ 20,955 |
Property, plant and equipment_2
Property, plant and equipment - Depreciation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Property and equipment | ||
Depreciation expense | $ 7,467 | $ 3,085 |
Guangzhou Biologics Business (D
Guangzhou Biologics Business (Details) $ in Thousands | Apr. 14, 2017CNY (¥) | Mar. 31, 2017CNY (¥)asset | Mar. 31, 2020USD ($) | Dec. 31, 2017 | Jun. 30, 2017CNY (¥) | Dec. 31, 2019USD ($) | Mar. 31, 2019USD ($) | Sep. 21, 2018 | Mar. 07, 2017CNY (¥) |
Organization | |||||||||
Cash and cash equivalents | $ | $ 1,957,101 | $ 618,011 | $ 764,492 | ||||||
Restricted cash | $ | $ 2,717 | ||||||||
Shareholder Loan | Convertible Debt | Investor | |||||||||
Organization | |||||||||
Face amount | ¥ 900,000,000 | ||||||||
Shareholder loan | ¥ 900,000,000 | ||||||||
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% | ||||||||
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% | ||||||||
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% | ||||||||
BeiGene Biologics Co., Ltd. (BeiGene Biologics) | |||||||||
Organization | |||||||||
Cash and cash equivalents | $ | $ 83,126 | ||||||||
Restricted cash | $ | $ 1,961 | ||||||||
BeiGene Biologics Co., Ltd. (BeiGene Biologics) | Shareholder Loan | Convertible Debt | Investor | |||||||||
Organization | |||||||||
Face amount | ¥ 900,000,000 | ||||||||
Shareholder loan | ¥ 900,000,000 | ||||||||
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 | Mar. 31, 2020 | Dec. 31, 2019 |
Intangible assets | ||
Gross carrying amount | $ 8,316 | $ 8,316 |
Accumulated amortization | (2,753) | (2,470) |
Intangible assets, net | 5,563 | 5,846 |
Product distribution rights | ||
Intangible assets | ||
Gross carrying amount | 7,500 | 7,500 |
Accumulated amortization | (1,937) | (1,750) |
Intangible assets, net | 5,563 | 5,750 |
Trading license | ||
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) | 3 Months Ended |
Mar. 31, 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 | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Intangible assets | ||
Amortization of intangible assets | $ 283 | $ 331 |
Intangible Assets - Expected Am
Intangible Assets - Expected Amortization Expense (Details) $ in Thousands | Mar. 31, 2020USD ($) |
Expected amortization expense | |
Remainder of 2020 | $ 563 |
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 | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Income taxes | ||
Income tax expense | $ 1,554 | $ 519 |
Increase in income taxes receivable | 5,586 | |
Unrecognized tax benefits | 5,003 | |
Increase in uncertain tax position | $ 369 |
Supplemental Balance Sheet In_3
Supplemental Balance Sheet Information - Allowance for credit losses (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Accounts Receivable, Allowance for Credit Loss | ||
Balance as of December 31, 2019 | $ 0 | |
Current period provision for expected credit losses | 2,022 | $ 0 |
Amounts written-off | 0 | |
Recoveries of amounts previously written-off | 0 | |
Balance as of March 31, 2020 | $ 2,022 |
Supplemental Balance Sheet In_4
Supplemental Balance Sheet Information - Prepaid expenses and other current assets (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Prepaid expenses and other current assets: | ||
Prepaid research and development costs | $ 75,867 | $ 69,715 |
Prepaid taxes | 17,392 | 9,498 |
Other receivables | 6,414 | 0 |
Interest receivable | 5,941 | 1,932 |
Prepaid insurance | 4,298 | 0 |
Prepaid manufacturing costs | 3,525 | 0 |
Other | 12,875 | 9,093 |
Total | $ 126,312 | $ 90,238 |
Supplemental Balance Sheet In_5
Supplemental Balance Sheet Information - Other non-current assets (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Other non-current assets: | ||
Goodwill | $ 109 | $ 109 |
Prepayment of property and equipment | 20,421 | 10,289 |
Prepayment of facility capacity expansion activities | 25,963 | 24,881 |
Prepaid VAT | 32,396 | 29,967 |
Rental deposits and other | 3,397 | 3,209 |
Long-term investment (Note 4) | 11,964 | 0 |
Total | $ 94,250 | $ 68,455 |
Supplemental Balance Sheet In_6
Supplemental Balance Sheet Information - Accrued expenses and other payables (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Accrued expenses and other payables | ||
Compensation related | $ 27,272 | $ 54,156 |
External research and development activities related | 53,428 | 62,794 |
Total amount of development funding payable in cash | 56,000 | 0 |
Commercial activities | 18,522 | 25,645 |
Income tax and other taxes | 11,944 | 9,648 |
Sales rebates and returns related | 4,014 | 3,198 |
Professional fees and other | 8,151 | 8,115 |
Total | $ 179,331 | $ 163,556 |
Supplemental Balance Sheet In_7
Supplemental Balance Sheet Information - Other long-term liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Other long-term liabilities | ||
Deferred government grant income | $ 45,134 | $ 46,391 |
Other | 171 | 171 |
Total | $ 45,305 | $ 46,562 |
Bank Loans (Details)
Bank Loans (Details) $ in Thousands | Jan. 13, 2020CNY (¥) | Apr. 04, 2018CNY (¥) | Mar. 31, 2020USD ($) | Mar. 31, 2019USD ($) | Mar. 31, 2020USD ($) | Mar. 31, 2020CNY (¥) | Jan. 19, 2020CNY (¥) |
Long-term bank loan | |||||||
Proceeds from long-term bank loan | $ 0 | $ 36,695 | |||||
Loans Payable | China Industrial Bank | |||||||
Long-term bank loan | |||||||
Short-term debt | 11,298 | $ 11,298 | |||||
Long Term Bank Loan, Jan 2021 | Loans Payable | China Industrial Bank | |||||||
Long-term bank loan | |||||||
Debt instrument term (in years) | 1 year | ||||||
Face amount | ¥ | ¥ 200,000,000 | ||||||
Fixed annual interest rate (as a percent) | 5.60% | ||||||
Long Term Bank Loan, Jan 2021 II | Loans Payable | China Industrial Bank | |||||||
Long-term bank loan | |||||||
Face amount | ¥ | ¥ 80,000,000 | ||||||
Loans Payable | |||||||
Long-term bank loan | |||||||
Interest expense | 1,719 | 941 | |||||
Interest capitalized | $ 66 | $ 641 | |||||
Loans Payable | Long Term Bank Loan April 2018 | |||||||
Long-term bank loan | |||||||
Debt instrument term (in years) | 9 years | ||||||
Loans Payable | Long Term Bank Loan April 2018 | China Construction Bank | |||||||
Long-term bank loan | |||||||
Face amount | ¥ | ¥ 580,000,000 | ||||||
Proceeds from long-term bank loan | $ 81,913 | ¥ 580,000,000 | |||||
Fixed annual interest rate (as a percent) | 4.90% | 4.90% |
Shareholder Loan (Details)
Shareholder Loan (Details) - Shareholder Loan - Investor - Convertible Debt $ in Thousands | Apr. 14, 2017CNY (¥) | Mar. 07, 2017CNY (¥) | Mar. 31, 2020USD ($) | Mar. 31, 2019USD ($) |
Shareholder Loan | ||||
Face amount | ¥ | ¥ 900,000,000 | |||
Shareholder loan | ¥ | ¥ 900,000,000 | |||
Shareholder loan interest rate (as a percent) | 8.00% | |||
Debt instrument term (in years) | 72 months | |||
Interest expense incurred due to a related party | $ | $ 2,572 | $ 2,645 | ||
Interest capitalized | $ | $ 0 | $ 788 |
Product Revenue - Product Sales
Product Revenue - Product Sales (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Revenues | ||
Product revenue – net | $ 52,059 | $ 77,833 |
Product | ||
Revenues | ||
Product revenue – gross | 53,188 | 58,536 |
Less: Rebates and sales returns | (1,129) | (1,115) |
Product revenue – net | 52,059 | 57,421 |
Product | Tislelizumab | ||
Revenues | ||
Product revenue – net | 20,526 | 0 |
Product | BRUKINSA™ | ||
Revenues | ||
Product revenue – net | 717 | 0 |
Product | ABRAXANE® | ||
Revenues | ||
Product revenue – net | 17,145 | 27,134 |
Product | REVLIMID® | ||
Revenues | ||
Product revenue – net | 7,628 | 23,584 |
Product | VIDAZA® | ||
Revenues | ||
Product revenue – net | $ 6,043 | $ 6,703 |
Product Revenue - Accrued Sales
Product Revenue - Accrued Sales Rebates and Returns (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Accrued Sales Rebates and Returns | ||
Beginning balance | $ 3,198 | |
Ending balance | 4,014 | |
Product | ||
Accrued Sales Rebates and Returns | ||
Beginning balance | 3,198 | $ 4,749 |
Accrual | 1,129 | 1,115 |
Payments | (313) | (2,498) |
Ending balance | $ 4,014 | $ 3,366 |
Loss Per Share (Details)
Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Numerator: | ||
Net loss attributable to BeiGene, Ltd. | $ (363,735) | $ (167,640) |
Denominator: | ||
Weighted-average shares outstanding, basic and diluted (shares) | 1,005,347,581 | 774,750,255 |
Net loss per share attributable to BeiGene, Ltd., basic and diluted (in dollars per share) | $ (0.36) | $ (0.22) |
Share-Based Compensation Expe_3
Share-Based Compensation Expense - Share Options and Incentive Plan (Details) - USD ($) $ / shares in Units, $ in Thousands | Feb. 28, 2020 | Aug. 30, 2019 | Feb. 28, 2019 | Jun. 06, 2018 | Dec. 31, 2018 | Mar. 31, 2020 | Dec. 31, 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) | 38,553,159 | |||||||
2016 Plan | Share options | ||||||||
Share-based compensation | ||||||||
Granted (in shares) | 462,449 | |||||||
Number of options outstanding (in shares) | 90,600,885 | |||||||
2016 Plan | Restricted Share Units (RSUs) | ||||||||
Share-based compensation | ||||||||
Granted (in shares) | 1,880,554 | |||||||
Number of options outstanding (in shares) | 25,109,448 | |||||||
2011 Plan | ||||||||
Share-based compensation | ||||||||
Shares cancelled or forfeited (in shares) | 5,152,236 | |||||||
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) | 79,404 | |||||||
2018 Plan | Restricted Share Units (RSUs) | ||||||||
Share-based compensation | ||||||||
Number of options outstanding (in shares) | 2,228,174 | |||||||
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) | 425,425 | 233,194 | 154,505 | |||||
Proceeds from shares issued | $ 4,048 | $ 2,192 | $ 1,385 | |||||
Share prices of ADS shares issues (in dollars per share) | $ 123.71 | $ 122.19 | $ 116.49 | |||||
Exercise price of shares issues (in dollars per share) | 9.52 | 9.40 | 8.96 | |||||
Share price, ADS (in dollars per share) | 158.35 | 143.75 | 137.05 | |||||
Share price (in dollars per share) | $ 12.18 | $ 11.06 | $ 10.54 |
Share-Based Compensation Expe_4
Share-Based Compensation Expense - Expense Recognized (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based compensation | ||
Compensation expense | $ 38,255 | $ 26,392 |
Research and development | ||
Share-based compensation | ||
Compensation expense | 20,399 | 15,771 |
Selling, general and administrative | ||
Share-based compensation | ||
Compensation expense | $ 17,856 | $ 10,621 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2020USD ($) | |
Movement in accumulated other comprehensive loss | |
Balance at the beginning of period | $ 978,355 |
Other comprehensive (loss)/ income before reclassifications | 2,693 |
Amounts reclassified from accumulated other comprehensive income | (1,240) |
Other comprehensive income, net of tax of nil | 1,453 |
Balance at the end of period | 2,827,056 |
Accumulated Other Comprehensive Income | |
Movement in accumulated other comprehensive loss | |
Balance at the beginning of period | (8,001) |
Balance at the end of period | (6,548) |
Foreign Currency Translation Adjustments | |
Movement in accumulated other comprehensive loss | |
Balance at the beginning of period | (9,291) |
Other comprehensive (loss)/ income before reclassifications | (4,245) |
Amounts reclassified from accumulated other comprehensive income | 0 |
Other comprehensive income, net of tax of nil | (4,245) |
Balance at the end of period | (13,536) |
Unrealized Gain on available-for-Sale Securities | |
Movement in accumulated other comprehensive loss | |
Balance at the beginning of period | 1,290 |
Other comprehensive (loss)/ income before reclassifications | 6,938 |
Amounts reclassified from accumulated other comprehensive income | (1,240) |
Other comprehensive income, net of tax of nil | 5,698 |
Balance at the end of period | $ 6,988 |
Shareholders_ Equity - Follow-o
Shareholders’ Equity - Follow-on public offerings (Details) $ / shares in Units, $ in Thousands | Jan. 02, 2020USD ($)$ / sharesshares |
Amgen, Inc | Beigene | |
Shareholders' equity | |
Minority interest in investment (as a percent) | 20.50% |
Amgen, Inc | |
Shareholders' equity | |
Shares issued (in shares) | shares | 15,895,001 |
Payments to acquire equity interest | $ | $ 2,779,241 |
Per share acquisition price (usd per share) | $ / shares | $ 174.85 |
Restricted Net Assets (Details)
Restricted Net Assets (Details) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 | Mar. 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% | ||
Appropriation to statutory reserves | $ 0 | $ 0 | |
China | |||
Segment Reporting Information | |||
Restricted net assets | $ 102,494,000 | $ 109,633,000 |
Commitments and Contingencies -
Commitments and Contingencies - Commitments (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Jan. 02, 2020 |
Purchase and Capital commitments | ||
Purchase commitments | $ 117,325 | |
Inventories | ||
Purchase and Capital commitments | ||
Purchase commitments | 20,639 | |
Minimum Purchase Commitments For Supply Purchased | ||
Purchase and Capital commitments | ||
Purchase commitments | 96,686 | |
Capital Addition Purchase Commitments | ||
Purchase and Capital commitments | ||
Purchase commitments | 60,645 | |
Amgen, Inc | ||
Purchase and Capital commitments | ||
Maximum cash and development services commitment | $ 1,250,000 | |
Remaining portion of development funding | $ 1,194,000 |
Segment and geographic inform_3
Segment and geographic information - General Information (Details) | 3 Months Ended |
Mar. 31, 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 | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Net product revenues by geographic area | ||
Revenues | $ 52,059 | $ 77,833 |
PRC | ||
Net product revenues by geographic area | ||
Revenues | 51,342 | 57,421 |
United States | ||
Net product revenues by geographic area | ||
Revenues | 717 | 13,268 |
Other | ||
Net product revenues by geographic area | ||
Revenues | $ 0 | $ 7,144 |
Subsequent Event (Details)
Subsequent Event (Details) | Apr. 13, 2020shares |
Subsequent Event | |
Subsequent Event | |
Increase in shares authorized (shares) | 57,200,000 |