1 unchanged sentence
Evaluation of Disclosure Controls and Procedures
−Removed: Based on their evaluation, required by paragraph (b) of Rules 13a-15 or 15d-15, promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act are
−Removed: effective, at a reasonable assurance level, as of December 31, 2019, to ensure that information required to be disclosed in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in U.S.
+Added: Based on their evaluation, required by paragraph (b) of Rules 13a-15 or 15d-15, promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act are effective, at a reasonable assurance level, as of December 31, 2020, to ensure that information required to be disclosed in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in U.S.
Securities and Exchange Commission rules and forms.
13 unchanged sentences
Other Information
−Removed: Not applicable.
+Added: Consulting Agreement
+Added: On February 24, 2021, the Company entered into a consulting agreement (the “2021 Consulting Agreement”) with Dr.
+Added: Xiaodong Wang, co-founder, director and Chairman of the Scientific Advisory Board, to renew the consulting arrangement between the Company and Dr.
+Added: Wang on substantially the same terms and conditions as his existing consulting agreement, which expired on December 31, 2020.
+Added: Pursuant to the 2021 Consulting Agreement, Dr.
+Added: Wang will continue to provide certain scientific and strategic advisory services to the Company as requested by the Company from time to time and will continue to receive an annual fixed consulting fee of $100,000 for such services and such additional compensation, if any, that will be determined in the sole discretion of the Company, subject to compliance with the requirements of the applicable stock exchange listing rules.
+Added: The 2021 Consulting Agreement is effective from January 1, 2021 and will expire on December 31, 2023.
+Added: The Company may terminate the 2021 Consulting Agreement upon 30 days’ prior notice to Dr.
+Added: Wang, provided that Dr.
+Added: Wang will be entitled to payment for services performed prior to such date.
+Added: The foregoing description of the 2021 Consulting Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the 2021 Consulting Agreement, a copy of which is filed as Exhibit 10.20 to this Annual Report on Form 10-K.
Directors, Executive Officers and Corporate Governance
36 unchanged sentences
generally accepted accounting principles.
−Removed: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2019, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated March 2, 2020 expressed an unqualified opinion thereon.
+Added: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2020, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 25, 2021 expressed an unqualified opinion thereon.
Adoption of New Accounting Standard
−Removed: As discussed in Note 2 to the consolidated financial statements, the Company changed its method for accounting for revenue from contracts with customers in the year ended December 31, 2018 and its method for accounting for leases in the year ended December 31, 2019.
+Added: As discussed in Note 2 to the consolidated financial statements, the Company changed its method for accounting for leases in the year ended December 31, 2019.
Basis for Opinion
6 unchanged sentences
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures include examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
We believe that our audits provide a reasonable basis for our opinion.
−Removed: Critical Audit Matter
−Removed: The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that:
−Removed: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.
−Removed: The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: Critical Audit Matters
+Added: The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
+Added: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.
+Added: The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Accrual of research and development expenses
−Removed: Description of the Matter
−Removed: During the year ended December 31, 2019, the Company recognized $927.3 million in research and development (“R&D”) expenses.
+Added: Description of the Matter During the year ended December 31, 2020, the Company recognized $1,294.9 million in research and development (“R&D”) expenses.
The balance of accrued external R&D activities related expenses as of December 31, 2020 amounted to approximately $143.3 million.
−Removed: As described in Note 2 to the consolidated financial statements, R&D expenses primarily include costs related to clinical trials and preclinical testing paid to third-party contract research organizations and contract manufacturing organizations (collectively referred as “Outsourced Service Providers”).
−Removed: Auditing the accrual of R&D expenses related to Outsourced Service Providers is complex because billing terms under contracts with Outsourced Service Providers often do not coincide with the timing of when the work is performed, which in turn requires management to make estimates of outstanding obligations as of period end.
−Removed: These estimates are based on a number of factors, including management’s knowledge of the R&D programs and activities associated with timelines, invoicing to date, and the provisions in the contracts.
−Removed: Significant management judgments and estimates are required in determining the accrued balances at the end of any reporting period and changes in those estimates can have a material effect on the amount of R&D expenses recognized.
−Removed: This in turn led to significant auditor judgment, subjectivity and effort in performing procedures to evaluate audit evidence for these estimates.
−Removed: How We Addressed the Matter in Our Audit
−Removed: We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the accrual of the R&D expenses.
+Added: As described in Note 2 to the consolidated financial statements, R&D expenses include costs related to clinical trials paid to third-party contract research organizations and contract manufacturing organizations (collectively referred as “Outsourced Service Providers”).
+Added: Auditing the accrual of R&D expenses related to Outsourced Service Providers is complex because the clinical trial activities with the Outsourced Service Providers are typically performed over an extended period with several milestones for the services in each agreement.
+Added: As a result, R&D expenses are allocated to each financial reporting period based upon the progress of the clinical trial activities.
+Added: Determining the progress of the clinical trial activities requires significant estimates and judgment.
+Added: These estimates are based on several factors, including management’s knowledge of the clinical trial activities associated with timelines, invoicing to date and the provisions in the contracts.
+Added: Changes in these estimates can have a material effect on the amount of R&D expenses recognized during the reporting period.
+Added: How We Addressed the Matter in Our Audit We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the accrual of the R&D expenses.
For example, we tested controls over management's review of the R&D accrual method and the estimates of the actual services performed by the Outsourced Service Providers.
−Removed: To test the accrual of R&D expenses, our audit procedures included, among others, reading the contracts with Outsourced Service Providers on a sample basis and understanding and testing management’s process for developing estimates based on the progress of the R&D activities.
−Removed: Testing management’s process for developing the accrual estimates involved evaluating the reasonableness of the assumptions used in the calculation related to the R&D programs and associated timelines, invoicing to date and the provisions in the contracts.
−Removed: We then evaluated the adequacy of the accrual of R&D expenses by comparing it to the subsequent progress billings issued by the Outsourced Service Providers.
−Removed: We also assessed the appropriateness of the accrual method used by the Company in accordance with U.S.
−Removed: generally accepted accounting principles, including the adequacy of related disclosures in the consolidated financial statements.
+Added: To test the accrual of R&D expenses, our audit procedures included, among others, reading the contracts with Outsourced Service Providers on a sample basis and understanding and testing the estimates on the progress of clinical trial activities developed by management.
+Added: Testing management’s estimates involved evaluating management's assumptions used in the calculation related to the clinical trial activities and associated timelines, invoicing to date and the provisions in the contracts.
+Added: We then evaluated the accrual of R&D expenses by comparing it to the subsequent progress billings issued by the Outsourced Service Providers.
+Added: We also assessed the accrual methodology used by the Company, including the adequacy of related disclosures in the consolidated financial statements.
+Added: Allocation of proceeds received in relation to the Amgen Collaboration and Share Purchase Agreements
+Added: Description of the Matter As discussed in Notes 3 and 19 to the consolidated financial statements, the Company entered into a collaboration arrangement and a share purchase agreement with Amgen Inc.
+Added: (collectively, the “Amgen Agreements”) and pursuant to which, the Company received cash proceeds of $2,779.2 million for a 20.5% ownership stake in the Company.
+Added: The Company determined that the proceeds paid by Amgen also represents a cost share liability due to the Company's co-development obligations (“R&D cost share liability”) in accordance with ASC 808 - Collaborative Arrangements (“ASC 808”), as the Company and Amgen are both active participants and are exposed to the risks and rewards dependent on the commercial success of the activities performed under the collaboration agreement.
+Added: The Company allocated the cash proceeds between the equity issued and the R&D cost share liability based on a relative fair value method.
+Added: On January 2, 2020, the closing date of the Amgen Agreements, the Company recognized $2,162.4 million in equity and $616.8 million in R&D cost share liability based on the allocation.
+Added: Auditing the allocation of cash proceeds received in relation to the Amgen Agreements is complex due to the significant estimates and judgments involved in determining the fair values of the equity component and liability component, including assessing the lack of marketability discount and the estimated future cashflows related to R&D activities, respectively.
+Added: The estimate of future cashflows related to R&D activities involved key assumptions such as revenue growth rates and probability of technical and regulatory success.
+Added: These significant assumptions are forward looking and could be affected by future economic, regulatory, and market conditions, which in turn led to significant auditor judgment, subjectivity and effort in performing procedures to evaluate audit evidence for these estimates.
+Added: How We Addressed the Matter in Our Audit We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the allocation of cash proceeds received in relation to the Amgen Agreements.
+Added: For example, we tested controls over management's review of the significant assumptions used in determining estimated future cashflows and the fair values of the equity issued and the R&D cost share liability.
+Added: To test the allocation of the cash proceeds received in relation to the Amgen Agreements, our audit procedures included, among others, evaluating the valuation methodologies, comparable companies and discount rate used by management to determine the fair values of equity issued and the R&D cost share liability, with the assistance of our internal valuation specialist.
+Added: We tested the significant underlying assumptions and the completeness and accuracy of the underlying data used by the Company in developing its estimated future cashflows, including revenue growth rates and probability of technical and regulatory success.
+Added: We compared these significant assumptions to current market trends, industry data, and current clinical stages of the pipeline assets.
+Added: We also performed sensitivity analysis by assessing the changes to the fair value of the equity and liability components resulting from changes in the lack of marketability discount and probability of technical and regulatory success.
+Added: In addition, we assessed the related disclosures in the consolidated financial statements.
/s/ Ernst & Young Hua Ming LLP
1 unchanged sentence
Beijing, People’s Republic of China
−Removed: March 2, 2020
+Added: February 25, 2021
Report of Independent Registered Public Accounting Firm
4 unchanged sentences
(the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2020, based on the COSO criteria.
−Removed: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2019 and 2018, the related consolidated statements of operations, comprehensive loss, cash flows and shareholders' equity for each of the three years in the period ended December 31, 2019, and the related notes and our report dated March 2, 2020 expressed an unqualified opinion thereon.
+Added: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2020 and 2019, the related consolidated statements of operations, comprehensive loss, cash flows and shareholders' equity for each of the three years in the period ended December 31, 2020, and the related notes and our report dated February 25, 2021 expressed an unqualified opinion thereon.
Basis for Opinion
16 unchanged sentences
Beijing, People’s Republic of China
−Removed: March 2, 2020
+Added: February 25, 2021
BEIGENE, LTD.
3 unchanged sentences
As of December 31,
+Added: Note 2020 2019
Current assets:
2 unchanged sentences
Short-term investments 6 3,268,725 364,728
−Removed: Accounts receivable
+Added: Accounts receivable, net 60,403 70,878
+Added: Inventories 7 89,293 28,553
Prepaid expenses and other current assets 13 160,012 90,238
1 unchanged sentence
Long-term restricted cash 5 7,748 2,476
−Removed: Property and equipment, net
−Removed: Land use right, net
+Added: Property, plant and equipment, net 10 357,686 242,402
Operating lease right-of-use assets 9 90,581 82,520
3 unchanged sentences
Total non-current assets 640,067 439,593
+Added: Total assets 5,600,757 1,612,289
Liabilities and shareholders' equity
2 unchanged sentences
Accrued expenses and other payables 13 346,144 163,556
−Removed: Deferred revenue, current portion
+Added: Tax payable 12 20,380 13,454
Operating lease liabilities, current portion 9 13,895 10,814
−Removed: Long-term bank loans, current portion
+Added: Research and development cost share liability, current portion 3 127,808 —
+Added: Short-term debt 14 335,015 —
Total current liabilities 1,075,199 310,312
Non-current liabilities:
−Removed: Long-term bank loans, non-current portion
+Added: Long-term bank loans 14 183,637 83,311
Shareholder loan 14 — 157,384
1 unchanged sentence
Deferred tax liabilities 12 10,792 10,532
+Added: Research and development cost share liability, non-current portion 3 375,040 —
Other long-term liabilities 13 57,429 46,562
6 unchanged sentences
Additional paid-in capital 7,414,932 2,925,970
−Removed: Accumulated other comprehensive (loss) income
+Added: Accumulated other comprehensive income (loss) 18 6,942 ( 8,001 )
Accumulated deficit ( 3,552,749 ) ( 1,955,843 )
2 unchanged sentences
Noncontrolling interest 8 — 16,150
+Added: Total equity 3,869,243 978,355
Total liabilities and equity 5,600,757 1,612,289
5 unchanged sentences
Year Ended December 31,
+Added: Note 2020 2019 2018
Product revenue, net 15 308,874 222,596 130,885
7 unchanged sentences
Loss from operations ( 1,657,682 ) ( 959,891 ) ( 705,769 )
−Removed: Interest income (expense), net
+Added: Interest income, net 1,998 9,131 13,947
Other income, net 6 37,490 7,174 1,993
−Removed: Loss before income tax expense
−Removed: Income tax (expense) benefit
+Added: Loss before income taxes ( 1,618,194 ) ( 943,586 ) ( 689,829 )
+Added: Income tax (benefit) expense 12 ( 17,671 ) 6,992 ( 15,796 )
+Added: Net loss ( 1,600,523 ) ( 950,578 ) ( 674,033 )
net loss attributable to noncontrolling interests ( 3,617 ) ( 1,950 ) ( 264 )
Net loss attributable to BeiGene, Ltd.
+Added: ( 1,596,906 ) ( 948,628 ) ( 673,769 )
Net loss per share attributable to BeiGene, Ltd., basic and diluted 16 ( 1.47 ) ( 1.22 ) ( 0.93 )
8 unchanged sentences
Year Ended December 31,
−Removed: Other comprehensive loss, net of tax of nil:
+Added: Note 2020 2019 2018
+Added: Net loss ( 1,600,523 ) ( 950,578 ) ( 674,033 )
+Added: Other comprehensive income (loss), net of tax of nil:
Foreign currency translation adjustments 18 23,603 ( 9,424 ) ( 478 )
+Added: Pension liability adjustments 21 ( 8,113 ) — —
Unrealized holding (loss) gain, net 18 ( 419 ) ( 448 ) 2,133
2 unchanged sentences
Comprehensive loss attributable to BeiGene, Ltd.
+Added: ( 1,581,963 ) ( 958,155 ) ( 672,026 )
The accompanying notes are an integral part of these consolidated financial statements.
4 unchanged sentences
Year Ended December 31,
+Added: Note 2020 2019 2018
Cash flows from operating activities:
+Added: Net loss ( 1,600,523 ) ( 950,578 ) ( 674,033 )
Adjustments to reconcile net loss to net cash used in operating activities:
2 unchanged sentences
Acquired in-process research and development 109,500 69,000 70,000
−Removed: Non-cash interest expense
+Added: Amortization of research and development cost share liability 3 ( 113,986 ) — —
+Added: Unrealized gains on equity investments 6 ( 11,826 ) — —
+Added: Gain on deconsolidation of a subsidiary 6 ( 11,307 ) — —
Deferred income tax benefits ( 27,807 ) ( 9,232 ) ( 21,949 )
2 unchanged sentences
Accounts receivable 10,363 ( 29,822 ) ( 11,628 )
+Added: Inventories ( 58,906 ) ( 12,311 ) ( 5,312 )
Prepaid expenses and other current assets ( 65,528 ) 45 ( 38,607 )
−Removed: Operating lease right-of-use assets
Other non-current assets 9,311 ( 20,782 ) ( 40,228 )
1 unchanged sentence
Accrued expenses and other payables 182,693 64,030 50,543
+Added: Tax payable 2,319 7,566 ( 3,355 )
Deferred revenue — ( 27,982 ) ( 9,059 )
1 unchanged sentence
Other long-term liabilities ( 25,401 ) 8,482 16,962
−Removed: Net cash (used in) provided by operating activities
+Added: Net cash used in operating activities ( 1,283,461 ) ( 750,269 ) ( 547,717 )
Cash flows from investing activities:
Purchases of property and equipment ( 117,508 ) ( 89,612 ) ( 70,283 )
+Added: Deconsolidation of a subsidiary ( 2,025 ) — —
Purchase of intangible assets — — ( 553 )
Payment for asset acquisition, net of cash acquired 4 — — ( 38,298 )
−Removed: Payment for the acquisition of land use right
−Removed: Cash acquired in business combination, net of cash paid
Purchases of investments ( 5,690,408 ) ( 1,169,300 ) ( 2,635,686 )
−Removed: Proceeds from sale or maturity of available-for-sale securities
+Added: Proceeds from sale or maturity of investments 2,751,075 1,882,075 2,177,207
Purchase of in-process research and development ( 109,500 ) ( 69,000 ) ( 70,000 )
−Removed: Net cash provided by (used in) investing activities
+Added: Net cash (used in) provided by investing activities ( 3,168,366 ) 554,163 ( 637,613 )
Cash flows from financing activities:
−Removed: Proceeds from public offering, net of underwriter discount
−Removed: Payment of public offering cost
−Removed: Proceeds from public offering and HK IPO, net of underwriter discount
−Removed: Payment of public offering and HK IPO costs
+Added: Proceeds from public offering, net 19 — — 757,587
+Added: Proceeds from public offering and HK IPO, net 19 — — 869,709
Proceeds from sale of ordinary shares, net of cost 19 4,232,017 — —
−Removed: Proceeds from long-term bank loans
−Removed: Repayment of long-term bank loans
−Removed: Proceeds from short-term loan
−Removed: Repayment of short-term loan
+Added: Proceeds from research and development cost share liability 3 616,834 — —
+Added: Payment to acquire joint venture ("JV") minority interest 8 ( 28,723 ) — —
+Added: Proceeds from loans 14 433,905 67,489 42,315
+Added: Repayment of loans 14 ( 144,308 ) ( 32,813 ) ( 8,736 )
Capital contribution from noncontrolling interest — 4,000 —
−Removed: Proceeds from shareholder loan
Proceeds from option exercises and employee share purchase plan 93,101 47,004 29,662
1 unchanged sentence
Effect of foreign exchange rate changes, net 18,231 ( 9,512 ) ( 4,096 )
−Removed: Net (decrease) increase in cash, cash equivalents, and restricted cash
+Added: Net increase (decrease) in cash, cash equivalents, and restricted cash 769,230 ( 119,938 ) 501,111
Cash, cash equivalents, and restricted cash, beginning of year 620,775 740,713 239,602
1 unchanged sentence
Year Ended December 31,
+Added: Note 2020 2019 2018
Supplemental cash flow disclosures:
4 unchanged sentences
Interest paid 44,130 4,315 2,209
−Removed: Non-cash activities:
−Removed: Discount provided on sale of ordinary shares for business combination
+Added: Supplemental non-cash activities:
Acquisitions of equipment included in accounts payable 42,762 29,086 22,105
7 unchanged sentences
Attributable to BeiGene, Ltd.
−Removed: Ordinary Shares
−Removed: Balance at December 31, 2016
−Removed: Issuance of ordinary shares in secondary follow-on offering, net of transaction costs
−Removed: Proceeds from sale of ordinary shares, net of cost
−Removed: Discount on the sale of ordinary shares
−Removed: Contributions from shareholders (Note 8)
−Removed: Share-based compensation
−Removed: Issuance of shares reserved for share option exercises
−Removed: Exercise of options
−Removed: Other comprehensive income
+Added: Ordinary Shares Additional
+Added: Capital Accumulated
+Added: Comprehensive
+Added: Income/(Loss) Accumulated
+Added: Deficit Total Non-
+Added: Shares Amount Total
+Added: $ $ $ $ $ $ $
Balance at December 31, 2017 592,072,330 59 1,000,747 ( 480 ) ( 330,517 ) 669,809 14,422 684,231
2 unchanged sentences
Issuance of ordinary shares in connection with follow-on public offering 102,970,400 10 757,577 — — 757,587 — 757,587
−Removed: Issuance of ordinary shares in connection with global offering and HK IPO
+Added: Issuance of ordinary shares in connection with HK IPO 65,600,000 7 869,702 — — 869,709 — 869,709
Issuance of shares reserved for share option exercises 1,299,186 — — — — — — —
1 unchanged sentence
Exercise of options and release of RSUs 14,321,268 1 29,661 — — 29,662 — 29,662
−Removed: Other comprehensive income
+Added: Other comprehensive income/(loss) — — — 1,743 — 1,743 ( 88 ) 1,655
+Added: Net loss — — — — ( 673,769 ) ( 673,769 ) ( 264 ) ( 674,033 )
Balance at December 31, 2018 776,263,184 77 2,744,814 1,526 ( 1,007,215 ) 1,739,202 14,445 1,753,647
4 unchanged sentences
Other comprehensive loss — — — ( 9,527 ) — ( 9,527 ) ( 345 ) ( 9,872 )
+Added: Net loss — — — — ( 948,628 ) ( 948,628 ) ( 1,950 ) ( 950,578 )
Balance at December 31, 2019 801,340,698 79 2,925,970 ( 8,001 ) ( 1,955,843 ) 962,205 16,150 978,355
+Added: Proceeds from issuance of ordinary shares, net of cost 145,838,979 14 2,069,596 — — 2,069,610 — 2,069,610
+Added: Issuance of ordinary shares in connection with collaboration 206,635,013 21 2,162,386 — — 2,162,407 — 2,162,407
+Added: Exercise of options, ESPP and release of RSUs 38,020,892 3 93,098 — — 93,101 — 93,101
+Added: Use of shares reserved for share option exercises and RSU releases ( 1,013,641 ) 1 — — — 1 — 1
+Added: Share-based compensation — — 183,481 — — 183,481 — 183,481
+Added: Deconsolidation of a subsidiary — — — — — — ( 3,545 ) ( 3,545 )
+Added: Acquisition of joint venture ("JV") minority interest — — ( 19,599 ) — — ( 19,599 ) ( 9,116 ) ( 28,715 )
+Added: Other comprehensive income — — — 14,943 — 14,943 128 15,071
+Added: Net loss — — — — ( 1,596,906 ) ( 1,596,906 ) ( 3,617 ) ( 1,600,523 )
+Added: Balance at December 31, 2020 1,190,821,941 118 7,414,932 6,942 ( 3,552,749 ) 3,869,243 — 3,869,243
The accompanying notes are an integral part of these consolidated financial statements.
6 unchanged sentences
BeiGene, Ltd.
−Removed: (the “Company”) is a global commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology cancer therapeutics.
−Removed: The Company started as a research and development company in Beijing in 2010.
−Removed: Over the last ten years, it has developed into a fully-integrated global biotechnology company, with significant commercial, manufacturing, and research and development capabilities.
−Removed: The Company has built substantial commercial capabilities in China and the United States, and is currently marketing two internally-developed drugs and three in-licensed drugs.
−Removed: The Company also anticipates introducing five more in-licensed drugs into the China market in the next one to two years.
−Removed: 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 and in China, the Company has received marketing approval and are in the process of launching tislelizumab for patients with classical Hodgkin’s Lymphoma ("cHL") who have received at least two prior therapies.
−Removed: The Company has filed four additional supplementary new drug applications ("sNDA") for regulatory approvals in China and is planning for launches in these additional indications in 2020.
−Removed: 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 company (“BMS”).
−Removed: 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.
−Removed: ("Amgen"), and SYLVANT ® (siltuximab) and QARZIBA ® ▼ (dinutuximab beta), from EUSA Pharma ("EUSA").
+Added: (the "Company", "BeiGene", "it", "its") is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and expand access for patients worldwide.
+Added: The Company has delivered ten molecules into the clinic in its first ten years, including its two lead commercial medicines, BRUKINSA ® , a small molecule inhibitor of Bruton’s Tyrosine Kinase (“BTK”) for the treatment of various blood cancers, and tislelizumab, an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers.
+Added: The Company is marketing BRUKINSA ® in the world’s two largest pharmaceutical markets, the United States and China, and tislelizumab in China, with an established, science-based commercial organization.
+Added: The Company has built state-of-the-art biologic and small molecule manufacturing facilities in China to support the potential future demand of its products, and it also works with high quality contract manufacturing organizations (“CMOs”) to manufacture its internally developed clinical and commercial products.
+Added: The Company is a leader in China-inclusive global clinical development, which it believes can facilitate faster and more cost-effective development of innovative medicines.
+Added: Its internal clinical development capabilities are deep, including a more than 1,600 -person global clinical development team that is running more than 60 ongoing or planned clinical trials.
+Added: This includes more than 25 pivotal or registration-enabling trials for three product candidates that have enrolled more than 12,000 patients and healthy volunteers, of which approximately one-half have been outside of China, as of January 2021.
+Added: The Company has over 45 products and product candidates in commercial stage or clinical development, including 7 approved medicines, 5 pending approval, and over 30 in clinical development.
+Added: Supported by its development and commercial capabilities, the Company has entered into collaborations with world-leading biopharmaceutical companies such as Amgen and Novartis to develop and commercialize innovative medicines globally.
+Added: Since its inception in 2010 in Beijing, the Company has become a fully integrated global organization of approximately 5,300 employees in 14 countries and regions, including China, the United States, Europe and Australia.
Summary of Significant Accounting Policies
5 unchanged sentences
Noncontrolling interests are recognized to reflect the portion of the equity of subsidiaries which are not attributable, directly or indirectly, to the controlling shareholders.
−Removed: The Company consolidates its interests in its joint ventures, BeiGene Biologics and MapKure, LLC, under the voting model and recognizes the minority shareholders' equity interest as a noncontrolling interest in its consolidated financial statements .
+Added: Prior to 2020, the Company consolidated its interests in its joint ventures, BeiGene Biologics Co., Ltd.
+Added: ("BeiGene Biologics") and MapKure, LLC ("MapKure"), under the voting model and recognized the minority shareholders' equity interest as a noncontrolling interest in its consolidated financial statements.
+Added: In June 2020, the Company deconsolidated MapKure and recorded an equity method investment for its remaining ownership interest in the joint venture (see Note 6).
+Added: In November 2020, the Company acquired the remaining equity interest in BeiGene Biologics.
+Added: Subsequent to the share purchase, BeiGene Biologics is a wholly owned subsidiary of the Company (see Note 8).
Use of Estimates
The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period.
−Removed: 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.
+Added: Areas where management uses subjective judgment include, but are not limited to, estimating the useful lives of long-lived assets, estimating variable consideration in product sales and collaboration revenue arrangements, identifying separate accounting units and the standalone selling price of each performance obligation in the Company’s revenue arrangements, estimating the fair value of net assets acquired in business combinations, assessing the impairment of long-lived assets, valuation and recognition of share-based compensation expenses, realizability of deferred tax assets, estimating uncertain tax positions, valuation of inventory,
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: estimating the allowance for credit losses, determining defined benefit pension plan obligations, measurement of right-of-use assets and lease liabilities and the fair value of financial instruments.
Management bases the estimates on historical experience, known trends and various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities.
6 unchanged sentences
The determination of functional currency is based on the criteria of Accounting Standard Codification (“ASC”) 830, Foreign Currency Matters .
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2019, 2018 AND 2017
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Foreign currency translation
14 unchanged sentences
The Company classifies restricted cash as current or non-current based on the term of the restriction.
−Removed: Accounts Receivable
−Removed: Trade accounts receivable are recorded at their invoiced amounts, net of trade discounts and allowances as well as allowances for doubtful accounts.
−Removed: An allowance for doubtful accounts is recorded when the collection of the full amount is no longer probable.
−Removed: In evaluating the collectability of receivable balances, the Company considers specific evidence including aging of the receivable, the customer's payment history, its current creditworthiness and current economic trends.
+Added: Accounts Receivable and Allowance for Credit Losses
+Added: Trade accounts receivable are recorded at their invoiced amounts, net of trade discounts and allowances as well as an allowance for credit losses.
+Added: The allowance for credit losses reflects the Company's current estimate of credit losses expected to be incurred over the life of the receivables.
+Added: 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.
+Added: 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.
−Removed: The Company regularly reviews the adequacy and appropriateness of any allowance for doubtful accounts.
−Removed: No allowance for doubtful accounts was recorded as of December 31, 2019 .
Prior to the regulatory approval of product candidates, the Company may incur expenses for the manufacture of drug product to support the commercial launch of those products.
Until the date at which regulatory approval has been received or is otherwise considered probable, all such costs are recorded as research and development expenses as incurred.
−Removed: To date the Company's inventory has consisted entirely of finished goods inventory purchased from Celgene Logistics Sàrl, a Bristol-Myers Squibb company ("BMS").
−Removed: Inventories are stated at the lower of cost and net realizable value, with cost determined on a weighted-average basis.
+Added: Inventories are stated at the lower of cost and net realizable value, with cost determined in a manner that approximates the first-in, first-out method.
The Company periodically analyzes its inventory levels, and writes down inventory that has become obsolete, inventory that has a cost basis in excess of its estimated realizable value and inventory in excess of expected sales requirements as cost of product sales.
−Removed: The determination of whether inventory costs will be realizable requires estimates by management.
−Removed: If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded in the consolidated statements of operations.
−Removed: There have been no write-downs or reserves against inventory to date.
−Removed: Short-Term Investments
−Removed: Investments with original maturities of greater than three months at the date of purchase and less than one year from the date of the balance sheet are classified as short-term.
−Removed: Short-term debt investments held to maturity are carried at amortized cost when the Company has the ability and positive intent to hold these securities until maturity.
−Removed: When the Company does not have the ability or positive intent to hold short-term debt investments until maturity, these securities are classified as available-for-sale.
−Removed: None of the Company’s fixed maturity securities met the criteria for held-to-maturity classification at December 31, 2019 and 2018 .
+Added: The determination of whether inventory costs will be realizable requires estimates by
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded in the consolidated statements of operations.
+Added: The Company's investments consist of available-for-sale debt securities, public equity securities with readily determinable fair values, private equity securities without readily determinable fair values, and equity-method investments.
+Added: The classification of an investment is determined based on the nature of the investment, the Company's ability and intent to hold the investment, and the degree to which the Company may exercise influence over the investee.
• Available-for-sale debt securities are stated at fair value, with the unrealized gains and losses, net of tax, reported in other comprehensive loss.
2 unchanged sentences
Interest and dividends are included in interest income.
−Removed: When the fair value of a debt security classified as available-for-sale is less than its amortized cost, the Company assesses whether or not:
−Removed: (i) it has the intent to sell the security or (ii) it is more likely than not that the Company will be required to sell the security before its anticipated recovery.
−Removed: If either of these conditions is met, the Company must recognize an other-than-temporary impairment through earnings for the difference between the debt security’s amortized cost basis and its fair value.
−Removed: No impairment losses were recorded for any periods presented.
−Removed: The cost of securities sold is based on the specific identification method.
−Removed: Property and Equipment
−Removed: Property and equipment are stated at cost, less accumulated depreciation and amortization.
+Added: Available-for-sale debt securities with original maturities greater than three months at the date of purchase and less than one year from the date of the balance sheet are classified as short-term.
+Added: Available-for-sale debt securities with maturities beyond one year may be classified as short-term marketable securities due to their highly liquid nature and because they represent the Company’s investments that are available for current operations.
+Added: • Public equity securities with readily determinable fair values are recorded at fair value.
+Added: Subsequent changes in fair value are recorded in other income, net.
+Added: Derivative financial instruments to purchase public equity securities are recorded at fair value.
+Added: The estimated fair value of derivative financial instruments is determined based on the Black-Scholes valuation model.
+Added: Changes in fair value of derivative instruments are recorded in other income, net.
+Added: • Private equity securities without readily determinable fair values and where the Company does not have significant influence are measured at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.
+Added: Adjustments to private equity securities are recorded in other income, net.
+Added: • Equity investments in common stock or in-substance common stock where the Company has significant influence over the financial and operating policies of the investee are accounted for as equity-method investments.
+Added: Equity-method investments are initially recorded at cost and subsequently adjusted based on the Company's percentage ownership in the investee's income and expenses, as well as dividends, if any.
+Added: The Company records its share of the investee's results of operations in other income, net.
+Added: The Company records impairment losses on our equity method investments if it deems the impairment to be other-than-temporary.
+Added: The Company deems an impairment to be other-than-temporary based on various factors, including but not limited to, the length of time the fair value is below the carrying value and ability to retain the investment to allow for a recovery in fair value.
+Added: Realized gains or losses on sales of investments are determined based on the specific identification method.
+Added: The Company regularly evaluates its investments in debt and equity for impairment.
+Added: The Company recognizes an allowance on available-for-sale debt securities when a portion of the unrealized loss is attributable to a credit loss and a corresponding credit loss in net income.
+Added: No impairment losses or allowance for credit losses on investments were recorded for any periods presented.
+Added: Property, Plant and Equipment
+Added: Property, plant and equipment are stated at cost, less accumulated depreciation and amortization.
Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets as follows:
−Removed: Manufacturing equipment
−Removed: 3 to 10 years
−Removed: Laboratory Equipment
−Removed: Software, Electronic and Office Equipment
−Removed: Leasehold Improvements
−Removed: Lesser of useful life or lease term
−Removed: Effective January 1, 2019, the Company adopted Accounting Standards Codification, Topic 842, Leases ("ASC 842") using the effective date method.
+Added: Building 20 years
+Added: Manufacturing equipment 3 to 10 years
+Added: Laboratory Equipment 3 to 5 years
+Added: Software, Electronic and Office Equipment 3 to 5 years
+Added: Leasehold Improvements Lesser of useful life or lease term
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: Effective January 1, 2019, the Company adopted ASC, Topic 842, Leases ("ASC 842") using the effective date method.
The Company determines if an arrangement is a lease at inception.
12 unchanged sentences
Lease terms are based on the non-cancelable term of the lease and may contain options to extend the lease when it is reasonably certain that the Company will exercise that option.
−Removed: Operating leases are included in operating lease right-of-use assets and lease liabilities on the consolidated balance sheet.
+Added: Operating leases are included in operating lease right-of-use assets and operating lease liabilities on the consolidated balance sheet.
Lease liabilities that become due within one year of the balance sheet date are classified as current liabilities.
1 unchanged sentence
Lease expense for these leases is recognized on a straight-line basis over the lease term.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2019, 2018 AND 2017
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Land Use Right, Net
9 unchanged sentences
The land use right is being amortized over the term of the land use right, which is 36 years.
+Added: In 2020, the Company acquired a land use right from the local Bureau of Land and Resources in Suzhou to expand its research, development and manufacturing facility in Suzhou.
+Added: The land use right is being amortized over the term of the land use right, which is 30 years.
Business Combinations
4 unchanged sentences
The consideration transferred in a business combination is measured as the aggregate of the fair values at the date of exchange of the assets given, liabilities incurred, and equity instruments issued as well as the contingent considerations and all contractual contingencies as of the acquisition date.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The costs directly attributable to the acquisition are expensed as incurred.
15 unchanged sentences
Goodwill is not amortized, but is tested for impairment at least annually or more frequently if events or changes in circumstances would indicate a potential impairment.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2019, 2018 AND 2017
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
The Company has elected to first assess qualitative factors to determine whether it is more likely than not that the fair value of the Company's reporting unit is less than its carrying amount, including goodwill.
5 unchanged sentences
Intangible assets acquired in transactions that are not business combinations are recorded at the allocated portion of total consideration transferred based on their relative fair value in relation to net assets acquired.
−Removed: Acquired identifiable intangible assets consist of distribution rights for approved cancer therapies licensed from BMS, ABRAXANE ® , REVLIMID®, and VIDAZA®, and are amortized on a straight-line basis over the estimated useful lives of the assets, which is 10 years , and the trading license which represents the Guangzhou drug distribution license acquired on September 21, 2018 (see Note 4).
−Removed: The Company is amortizing the trading license over the remainder of the license term through February 2020.
+Added: Acquired identifiable intangible assets consist of distribution rights for approved cancer therapies licensed from BMS, and are amortized on a straight-line basis over the estimated useful lives of the assets, which is 10 years, and the trading license which represents the Guangzhou drug distribution license acquired in September 2018 (see Note 4).
+Added: The Company amortized the trading license over the remainder of the initial license term through February 2020.
Intangible assets with finite useful lives are tested for impairment when events or circumstances occur that could indicate that the carrying amount of an asset may not be recoverable.
1 unchanged sentence
If the sum of the expected undiscounted cash flows is less than the carrying amount of the assets, the Company recognizes an impairment loss based on the excess of the carrying amount of the assets over their fair value.
−Removed: Fair value is generally determined by discounting the cash flows expected to be generated by the assets, when the market prices are not readily available.
+Added: Fair value is generally determined by discounting the cash flows expected to be
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: generated by the assets, when the market prices are not readily available.
For the years ended December 31, 2020, 2019 and 2018, the Company determined that there were no indicators of impairment of its other intangible assets.
6 unchanged sentences
Fair value of financial instruments
−Removed: Financial instruments of the Company primarily include cash and cash equivalents, restricted cash, short-term investments, accounts receivable, long-term bank loans, Shareholder Loan (as defined in Note 15) and accounts payable.
−Removed: As of December 31, 2019 and 2018 , the carrying values of cash and cash equivalents, restricted cash, accounts receivable and accounts payable approximated their fair values due to the short-term maturity of these instruments.
−Removed: The short-term investments represented the available-for-sale debt securities.
−Removed: The available-for-sale debt securities are recorded at fair value based on quoted prices in active markets with unrealized gain or loss recorded in other comprehensive loss.
−Removed: The long-term bank loans and Shareholder Loan approximate their fair value due to the fact that the related interest rates approximate the rates currently offered by financial institutions for similar debt instrument of comparable maturities.
The Company applies ASC topic 820 (“ASC 820”), Fair Value Measurements and Disclosures, in measuring fair value.
3 unchanged sentences
Level 2 — Include other inputs that are directly or indirectly observable in the marketplace.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2019, 2018 AND 2017
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Level 3 — Unobservable inputs which are supported by little or no market activity.
7 unchanged sentences
Financial instruments measured at fair value on a recurring basis
−Removed: The following tables set forth assets and liabilities measured at fair value on a recurring basis as of December 31, 2019 and 2018 :
−Removed: As of December 31, 2019
−Removed: Short-term investment (Note 6):
−Removed: treasury securities
+Added: The following tables set forth assets measured at fair value on a recurring basis as of December 31, 2020 and 2019:
+Added: As of December 31, 2020 Quoted Price
+Added: (Level 1) Significant
+Added: (Level 2) Significant
Cash equivalents
1 unchanged sentence
Money market funds 80,838 — —
−Removed: As of December 31, 2018
−Removed: Short-term investment (Note 6):
+Added: Short-term investments (Note 6):
treasury securities 3,268,725 — —
+Added: Other non-current assets (Note 6):
+Added: Equity securities with readily determinable fair values 10,810 6,669 —
+Added: Total 3,646,445 6,669 —
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: As of December 31, 2019 Quoted Price
+Added: (Level 1) Significant
+Added: (Level 2) Significant
Cash equivalents
+Added: treasury securities 16,442 — —
Money market funds 50,461 — —
+Added: Short-term investments (Note 6):
+Added: treasury securities 364,728 — —
+Added: Total 431,631 — —
+Added: The Company's cash equivalents are highly liquid investments with original maturities of 3 months or less.
+Added: Short-term investments represent the Company's investments in available-for-sale debt securities.
+Added: The Company determines the fair value of cash equivalents and available-for-sale debt securities using a market approach based on quoted prices in active markets.
+Added: The Company's equity securities carried at fair value consist of holdings in common stock and warrants to purchase additional shares of common stock of Leap Therapeutics, Inc.
+Added: ("Leap"), which were acquired in connection with a collaboration and license agreement entered into in January 2020.
+Added: The common stock investment in Leap, a publicly-traded biotechnology company, is measured and carried at fair value and classified as Level 1.
+Added: 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.
+Added: Refer to Note 2, Investments for details of the determination of the carrying amount of private equity investments without readily determinable fair values and equity method investments.
+Added: As of December 31, 2020 and 2019, the fair values of cash and cash equivalents, restricted cash, accounts receivable, accounts payable, and short-term debt approximated their carrying values due to their short-term nature.
+Added: Long-term bank loans and the Shareholder Loan approximate their fair value due to the fact that the related interest rates approximate the rates currently offered by financial institutions for similar debt instrument of comparable maturities.
Revenue Recognition
−Removed: Effective January 1, 2018, the Company adopted Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers (“ASC 606”) using the modified retrospective method.
+Added: Effective January 1, 2018, the Company adopted ASC, Topic 606, Revenue from Contracts with Customers (“ASC 606”) using the modified retrospective method.
Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services.
6 unchanged sentences
The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer.
+Added: Once a contract is determined to be within the scope of ASC 606 at contract inception, the Company reviews the contract to determine which performance obligations it must deliver and which of these performance obligations are distinct.
+Added: The Company recognizes as revenue the amount of the transaction price that is allocated to each performance obligation when that performance obligation is satisfied or as it is satisfied.
+Added: Product Revenue
+Added: The Company generates product revenues in China through the sale of its internally developed drugs tislelizumab and BRUKINSA ® , and the sale of in-licensed products in China through its agreements with Amgen and BMS.
+Added: Under the commercial profit share arrangement with Amgen, the Company is the principal for in-licensed product sales to customers in China during the commercialization period and recognizes 100% of net product revenue on these sales.
+Added: Amounts due to Amgen
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: Once a contract is determined to be within the scope of ASC 606 at contract inception, the Company reviews the contract to determine which performance obligations it must deliver and which of these performance obligations are distinct.
−Removed: The Company recognizes as revenue the amount of the transaction price that is allocated to each performance obligation when that performance obligation is satisfied or as it is satisfied.
−Removed: Product revenue
−Removed: The Company's product revenues are generated from the sale of ABRAXANE, REVLIMID, and VIDAZA to its product distributor in China, the Company's sole customer in China.
−Removed: The first tier distributor subsequently resells the products to second tier distributors who ultimately sell the products to health care providers and patients.
−Removed: Following FDA approval on November 14, 2019, the Company began selling its first internally developed drug, BRUKINSA, in the United States to specialty pharmacies and specialty distributors, the Company's U.S.
+Added: for its portion of net product sales are recorded as cost of sales.
+Added: In the United States, the Company generates product revenues from the sale of BRUKINSA ® .
+Added: In China, the Company sells its internally developed products to multiple distributors, who in turn sells the product to hospitals or pharmacies within their authorized territories to be sold ultimately to patients.
+Added: In-licensed products are sold to a first tier distributor who subsequently resells the products to second tier distributors who ultimately sell the products to health care providers and patients.
+Added: In the United States, the Company distributes BRUKINSA ® through specialty pharmacies and specialty distributors.
The specialty pharmacies and specialty distributors subsequently resell the product to health care providers and patients.
7 unchanged sentences
If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.
−Removed: In China, rebates, including price compensation credits, are offered to distributors, consistent with pharmaceutical industry practices.
+Added: In China, rebates are offered to distributors.
The Company records a provision for rebates at the time of sale based on contracted rates and historical redemption rates.
3 unchanged sentences
Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns.
−Removed: product revenues and related reserves for variable consideration were not significant for the year ended December 31, 2019 as the Company did not begin generating product revenue in the United States until after BRUKINSA received FDA approval on November 14, 2019.
The Company bases its sales returns allowance on estimated distributor inventories, customer demand as reported by third-party sources, and actual returns history, as well as other factors, as appropriate.
6 unchanged sentences
For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and therefore within the scope of ASC 606.
−Removed: For elements of
+Added: For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently.
+Added: In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the five-step model under ASC 606 noted above.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently.
−Removed: In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the five-step model under ASC 606 noted above.
The Company’s collaborative arrangements may contain more than one unit of account, or performance obligation, including grants of licenses to intellectual property rights, agreement to provide research and development services and other deliverables.
24 unchanged sentences
Clinical trial costs are a significant component of the Company’s research and development expenses.
−Removed: The Company has a history of contracting with third parties that perform various clinical trial activities on behalf of the Company in the ongoing
+Added: The Company has a history of contracting with third parties that perform various clinical trial activities on behalf of the Company in the ongoing development of the Company’s product candidates.
+Added: Expenses related to clinical trials are accrued based on the Company’s estimates of the actual services performed by the third parties for the respective period.
+Added: If the contracted amounts are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), the Company will modify the related accruals accordingly on a prospective basis.
+Added: Revisions in the scope of a contract are charged to expense in the period in which the facts that give rise to the revision become reasonably certain.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: development of the Company’s product candidates.
−Removed: Expenses related to clinical trials are accrued based on the Company’s estimates of the actual services performed by the third parties for the respective period.
−Removed: If the contracted amounts are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), the Company will modify the related accruals accordingly on a prospective basis.
−Removed: Revisions in the scope of a contract are charged to expense in the period in which the facts that give rise to the revision become reasonably certain.
+Added: The process of estimating the Company's research and development expenses involves reviewing open contracts and purchase orders, communicating with its personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated costs incurred for the services when the Company has not yet been invoiced or otherwise notified of the actual costs.
+Added: The majority of the Company's service providers invoice it in arrears for services performed, on a pre‑determined schedule or when contractual milestones are met;
+Added: however, some require advanced payments.
+Added: The Company makes estimates of the expenses as of each balance sheet date in its financial statements based on facts and circumstances known to the Company at that time.
+Added: Although the Company does not expect its estimates to be materially different from amounts actually incurred, the understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting expenses that are too high or too low in any particular period.
There were no material adjustments for a change in estimate to research and development expenses in the accompanying consolidated financial statements for the years ended December 31, 2020, 2019 and 2018.
10 unchanged sentences
Among other disclosures, ASC 220, Comprehensive Income , requires that all items that are required to be recognized under current accounting standards as components of comprehensive loss be reported in a financial statement that is displayed with the same prominence as other financial statements.
−Removed: For each of the periods presented, the Company’s comprehensive loss includes net loss, foreign currency translation adjustments and unrealized holding gains/losses associated with the available-for-sale debt securities, and is presented in the consolidated statements of comprehensive loss.
+Added: For each of the periods presented, the Company’s comprehensive loss includes net loss, foreign currency translation adjustments, pension liability adjustments and unrealized holding gains/losses associated with the available-for-sale debt securities, and is presented in the consolidated statements of comprehensive loss.
Share-Based Compensation
9 unchanged sentences
ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in the subsequent period if actual forfeitures differ from initial estimates.
−Removed: Forfeiture rates are estimated based on historical and future expectations of employee turnover rates and are adjusted to reflect future changes in circumstances and facts, if any.
−Removed: Share-based compensation expense is recorded net of estimated forfeitures such that expense is recorded only for those share-based awards that are expected to vest.
−Removed: To the extent the Company
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: revises these estimates in the future, the share-based payments could be materially impacted in the period of revision, as well as in following periods.
+Added: Forfeiture rates are estimated based on historical and future expectations of employee turnover rates and are adjusted to reflect future changes in circumstances and facts, if any.
+Added: Share-based compensation expense is recorded net of estimated forfeitures such that expense is recorded only for those share-based awards that are expected to vest.
+Added: To the extent the Company revises these estimates in the future, the share-based payments could be materially impacted in the period of revision, as well as in following periods.
The Company, with the assistance of an independent third-party valuation firm, determined the estimated fair value of the stock options granted to employees using the binomial option pricing model.
2 unchanged sentences
All transactions in which goods or services are received in exchange for equity instruments are accounted for based on the fair value of the consideration received or the fair value of the equity instrument issued, whichever is more reliably measurable.
−Removed: The measurement date of the fair value of the equity instrument issued is the date on which the counterparty’s performance is completed as there is no associated performance commitment.
+Added: The grant date is the measurement date of the fair value of the equity instrument issued.
The expense is recognized in the same manner as if the Company had paid cash for the services provided by the non-employees in accordance with ASC 505-50, Equity-based payments to non-employees .
20 unchanged sentences
For the periods presented herein, the computation of basic loss per share using the two-class method is not applicable as the Company is in a net loss position.
−Removed: Diluted loss per share is calculated by dividing net loss attributable to ordinary shareholders as adjusted for the effect of dilutive ordinary equivalent shares, if any, by the weighted average number of ordinary and dilutive ordinary equivalent shares
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: outstanding during the period.
+Added: Diluted loss per share is calculated by dividing net loss attributable to ordinary shareholders as adjusted for the effect of dilutive ordinary equivalent shares, if any, by the weighted average number of ordinary and dilutive ordinary equivalent shares outstanding during the period.
Ordinary equivalent shares consist of the ordinary shares issuable upon the conversion of the Company’s convertible preferred shares using the if-converted method, and ordinary shares issuable upon the conversion of the share options and unvested restricted shares, using the treasury stock method.
10 unchanged sentences
The deposits placed with financial institutions are not protected by statutory or commercial insurance.
−Removed: In the event of bankruptcy of one of these financial institutions, the Company may be unlikely to claim its deposits back in full.
+Added: In the event of bankruptcy of one of these financial institutions, the Company may be unable to claim its deposits back in full.
Management believes that these financial institutions are of high credit quality and continually monitors the credit worthiness of these financial institutions.
3 unchanged sentences
The Company believes that U.S.
−Removed: treasury securities are of high credit quality and continually monitor the credit worthiness of these institutions.
+Added: treasury securities are of high credit quality and continually monitors the credit worthiness of these institutions.
Customer concentration risk
−Removed: For the years ended December 31, 2019 , 2018 and 2017, substantially all of the Company's revenue was from BMS and our product distributor, China Resources, in China.
+Added: For the year ended December 31, 2020, sales to the Company's two largest product distributors, China Resources and Sinopharm, represented approximately 38.7 % and 25.4 % of product revenue, respectively, and collectively, represented approximately 59.6 % of total accounts receivable as of December 31, 2020.
+Added: For the years ended December 31, 2019 and 2018, substantially all of the Company's revenue was from BMS and the Company's product distributor, China Resources, in China.
Business, customer, political, social and economic risks
1 unchanged sentence
changes in the overall demand for services and products;
−Removed: competitive pressures due to new entrants;
+Added: competitive pressures due to existing competitors and new entrants;
advances and new trends in new drugs and industry standards;
4 unchanged sentences
and risks associated with the Company’s ability to attract and retain employees necessary to support its growth.
−Removed: The Company’s operations could be also adversely affected by significant political, economic and social uncertainties in the PRC.
+Added: The Company’s operations could be also adversely affected by significant political, economic and social uncertainties in the PRC and in relations between the PRC and United States.
Currency convertibility risk
1 unchanged sentence
On January 1, 1994, the PRC government abolished the dual rate system and introduced a single rate of exchange as quoted daily by the People’s Bank of China (the “PBOC”).
−Removed: However, the unification of the exchange rates does not imply that the RMB may be readily convertible into U.S.
−Removed: dollar or other foreign currencies.
−Removed: All foreign exchange transactions continue to take place either through the PBOC or other banks authorized to buy and sell foreign currencies at the exchange rates quoted by the PBOC.
−Removed: Approvals of foreign currency payments by the PBOC or other institutions require submitting a payment application form together with suppliers’ invoices, shipping documents and signed contracts.
−Removed: Additionally, the value of the RMB is subject to changes in central government policies and international economic and political developments affecting supply and demand in the PRC foreign exchange trading system market.
+Added: However, the unification of the exchange rates does not imply that the RMB may be readily
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: convertible into U.S.
+Added: dollar or other foreign currencies.
+Added: All foreign exchange transactions continue to take place either through the PBOC or other banks authorized to buy and sell foreign currencies at the exchange rates quoted by the PBOC.
+Added: Approvals of foreign currency payments by the PBOC or other institutions require submitting a payment application form together with suppliers’ invoices, shipping documents and signed contracts.
+Added: Additionally, the value of the RMB is subject to changes in central government policies and international economic and political developments affecting supply and demand in the PRC foreign exchange trading system market.
Foreign currency exchange rate risk
−Removed: From July 21, 2005, the RMB is permitted to fluctuate within a narrow and managed band against a basket of certain foreign currencies.
+Added: Since July 21, 2005, the RMB is permitted to fluctuate within a narrow and managed band against a basket of certain foreign currencies.
For RMB against U.S.
−Removed: dollar, there was depreciation of approximately 1.3 % , depreciation of approximately 5.7 % and appreciation of approximately 6.5 % , in the years ended December 31, 2019 , 2018 and 2017 .
+Added: dollar, there was appreciation of approximately 6.3 %, depreciation of approximately 1.3 % and depreciation of approximately 5.7 %, in the years ended December 31, 2020, 2019 and 2018.
It is difficult to predict how market forces or PRC or U.S.
13 unchanged sentences
New accounting standards which have been adopted
−Removed: In February 2016, the Financial Accounting Standards Board ("FASB") issued ASU No.
−Removed: 2016-2, Leases .
−Removed: Subsequently, the FASB issued ASU 2018-1, Land Easement Practical Expedient , which provides an optional transition practical expedient for land easements, ASU 2018-10, Codification Improvements to Topic 842, Leases , which clarifies certain aspects of the guidance issued in ASU 2016-2;
−Removed: ASU 2018-11, Leases (Topic 842):
−Removed: Targeted Improvements , which provides an additional transition method and a practical expedient for separating components of a contract for lessors, ASU 2018-20, Leases (Topic 842)- Narrow-Scope Improvements for Lessors , which allows certain accounting policy elections for lessors;
−Removed: and ASU 2019-1, Leases (Topic 842):
−Removed: Codification Improvements , which clarifies certain aspects of the guidance (collectively, the "Lease ASUs").
−Removed: The Lease ASUs require lessees to recognize assets and liabilities related to lease arrangements longer than 12 months on the balance sheet.
−Removed: This standard also requires additional disclosures by lessees and contains targeted changes to accounting by lessors.
−Removed: The updated guidance was effective for interim and annual periods beginning after December 15, 2018, with early adoption permitted.
−Removed: Leases will be classified as finance or operating, with the classification affecting the pattern and classification of expense recognition.
−Removed: The recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee have not significantly changed from previous GAAP.
−Removed: A modified retrospective transition approach is required, applying the new standard to all leases existing at the date of initial adoption.
−Removed: The guidance permits entities to choose to use either its effective date or the beginning of the earliest period presented in the financial statements as its date of initial application.
−Removed: The Company adopted the new standard effective January 1, 2019 using the effective date method and did not restate comparative periods.
−Removed: The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which permits the Company not to reassess under the new standard its prior conclusions about lease identification, lease classification and initial direct costs.
−Removed: Upon adoption, the Company recognized a lease liability of $ 27,446 , with corresponding ROU assets of $ 25,978 based on the present value of the remaining minimum rental payments under existing operating leases.
−Removed: The difference between the lease liability and right-of-use asset relates to the reversal of existing deferred rent and prepaid rent balances of $ 1,739 and $ 271 , respectively.
−Removed: Additionally, the Company reclassified its land use rights of $ 45,058 to ROU assets upon adoption.
−Removed: The adoption of the standard did not impact the Company’s consolidated statements of operations or cash flows.
−Removed: In February 2018, the FASB issued ASU 2018-02, Income Statement-Reporting Comprehensive Income (Topic 220):
−Removed: Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income .
−Removed: This update provides companies the option to reclassify to retained earnings the income tax accounting effects related to items originating in accumulated other comprehensive income ("AOCI") as a result of the U.S.
−Removed: Tax Cuts and Jobs Act ("TCJA") enacted on December 22, 2017.
−Removed: This update was effective in fiscal years, including interim periods, beginning after December 15, 2018, with early adoption permitted.
−Removed: None of the income tax accounting effects of the TCJA related to items that originated in AOCI and thus adopting of this standard did not have any impact on the Company’s consolidated financial statements.
−Removed: Other tax effects of items that originate in AOCI will be removed when the underlying circumstance which gives rise to the tax impact no longer exists, based on an aggregate portfolio approach.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2019, 2018 AND 2017
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: Impact of adopted accounting standards
−Removed: The cumulative effect of changes made to the Company’s consolidated January 1, 2019 balance sheet for the adoption of the Lease ASUs were as follows:
−Removed: Prepaid expenses and other current assets
−Removed: Land use right, net
−Removed: Operating lease right-of-use assets
−Removed: Accrued expenses and other payables
−Removed: Current portion of operating lease liabilities
−Removed: Operating lease liabilities
−Removed: Other long-term liabilities
−Removed: New accounting standards which have not yet been adopted
−Removed: In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses ("ASU 2016-13").
+Added: 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):
−Removed: Targeted Transition Relief and ASU 2019-11 Codification Improvements to Topic 326, Financial Instruments- Credit Losses .
−Removed: The amendments in ASU 2016-13 update guidance on reporting credit losses for financial assets.
−Removed: These amendments affect loans, debt securities, trade receivables, net investments in leases, off balance sheet credit exposures, reinsurance receivables, and any other financial assets not excluded from the scope that have the contractual right to receive cash.
−Removed: For public business entities that are U.S.
−Removed: SEC filers, ASU 2016-13 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years.
−Removed: The Company does not currently anticipate the adoption of this ASU to have a material impact to its financial statements.
+Added: Targeted Transition Relief and ASU 2019-11 Codification Improvements to Topic 326, Financial Instruments- Credit Losses (collectively, the "Credit Loss ASUs").
+Added: The Credit Loss ASUs change the methodology to be used to measure credit losses for certain financial instruments and financial assets, including trade receivables.
+Added: 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.
+Added: 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.
+Added: The Company adopted the standard on January 1, 2020.
+Added: 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.
+Added: 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):
1 unchanged sentence
The update eliminates, modifies, and adds certain disclosure requirements for fair value measurements.
−Removed: This update is effective in fiscal years, including interim periods, beginning after December 15, 2019, and early adoption is permitted.
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.
−Removed: The Company does not expect the impact of this guidance to have a material impact on the Company’s consolidated financial statements.
+Added: The Company adopted this standard on January 1, 2020.
+Added: 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):
1 unchanged sentence
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.
−Removed: This update is effective in fiscal years, including interim periods, beginning after December 15, 2019, and early adoption is permitted.
This guidance should be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption.
−Removed: The Company does not expect the impact of this guidance to have a material impact on the Company’s consolidated financial statements.
−Removed: In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808):
−Removed: Clarifying the Interaction between Topic 808 and Topic 606 .
−Removed: 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.
−Removed: The update is effective in fiscal years beginning after December 15, 2019, and interim periods therein, and early adoption is permitted for entities that have adopted ASC 606.
−Removed: This guidance should be
+Added: The Company adopted this standard on January 1, 2020.
+Added: There was no material impact to the Company's financial position or results of operations upon adoption.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: applied retrospectively to the date of initial application of Topic 606.
−Removed: The Company does not expect the impact of this guidance to have a material impact on the Company’s consolidated financial statements.
+Added: In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808) :
+Added: Clarifying the Interaction between Topic 808 and Topic 606.
+Added: 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.
+Added: This guidance should be applied retrospectively to the date of initial application of Topic 606.
+Added: The Company adopted this standard on January 1, 2020.
+Added: There was no material impact to the Company's financial position or results of operations upon adoption.
+Added: New accounting standards which have not yet been adopted
In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740):
7 unchanged sentences
The Company enters into collaborative arrangements for the research and development, manufacture and/or commercialization of drug products and drug candidates.
−Removed: 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 cost sharing arrangements.
+Added: To date, these collaborative arrangements have included out-licenses of internally developed products and drug candidates to other parties, in-licenses of products and drug candidates from other parties, and profit- and cost-sharing arrangements.
These arrangements may include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost-sharing and reimbursement arrangements, royalty payments, and profit sharing.
3 unchanged sentences
Year Ended December 31,
−Removed: Revenues from Collaboration Partners
−Removed: License revenue
+Added: 2020 2019 2018
+Added: Revenue from Collaborators $ $ $
Reimbursement of research and development costs — 27,634 56,776
Research and development service revenue — 27,982 10,559
−Removed: Celgene Corporation, a Bristol-Myers Squibb company ("BMS")
−Removed: 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”).
−Removed: In connection with the closing of the transactions on August 31, 2017, the Company, and BMS amended and restated the PD-1 License Agreement (the “A&R PD-1 License Agreement”) to, among other things, clarify the parties’ responsibilities relating to the conducting and funding of certain global registration clinical trials and clarify the scope of the regulatory materials transferred by BeiGene to BMS.
−Removed: The Company entered into a mutual agreement with BMS to terminate the A&R PD-1 License Agreement effective June 14, 2019 in advance of the acquisition of Celgene by BMS.
−Removed: Under the terms of the A&R PD-1 License Agreement, BMS paid the Company $ 263,000 in upfront non-refundable fees, of which $ 92,050 was paid in the third quarter of 2017 and the remaining $ 170,950 was paid in December 2017.
−Removed: The Company allocated $ 13,000 of upfront fees to the fair value of assets related to the Company’s acquisition of Celgene Shanghai, a wholly-
+Added: Other — 150,000 —
+Added: Total — 205,616 67,335
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: owned subsidiary of Celgene Holdings East Corporation established under the laws of China, which was completed contemporaneously with the A&R PD-1 License Agreement.
+Added: Celgene Corporation, a Bristol Myers Squibb company ("BMS")
+Added: On July 5, 2017, the Company entered into a license agreement with Celgene Corporation, now a BMS company, pursuant to which the Company granted to the BMS parties an exclusive right to develop and commercialize the Company’s investigational PD-1 inhibitor, tislelizumab, in all fields of treatment, other than hematology, in the United States, Europe, Japan and the rest of world other than Asia (the “PD-1 License Agreement”).
+Added: In connection with the closing of the transactions on August 31, 2017, the Company and BMS amended and restated the PD-1 License Agreement (the “A&R PD-1 License Agreement”) to, among other things, clarify the parties’ responsibilities relating to the conducting and funding of certain global registration clinical trials and clarify the scope of the regulatory materials transferred by BeiGene to BMS.
+Added: The Company entered into a mutual agreement with BMS to terminate the A&R PD-1 License Agreement effective June 14, 2019 in advance of the acquisition of Celgene by BMS.
+Added: Under the terms of the A&R PD-1 License Agreement, BMS paid the Company $ 263,000 in upfront non-refundable fees, of which $ 92,050 was paid in the third quarter of 2017 and the remaining $ 170,950 was paid in December 2017.
+Added: The Company allocated $ 13,000 of upfront fees to the fair value of assets related to the Company’s acquisition of Celgene Shanghai, a wholly-owned subsidiary of Celgene Holdings East Corporation established under the laws of China, which was completed contemporaneously with the A&R PD-1 License Agreement.
The Company was also eligible to receive product development and commercial milestone payments based on the successful achievement of development and regulatory and commercialization goals, respectively, and potential royalty payments.
15 unchanged sentences
For the year ended December 31, 2018, the Company recognized collaboration revenue of $ 65,835 related to the BMS collaboration, which consisted of $ 56,776 of research and development reimbursement revenue for the trials that BMS had opted into and research and development services revenue of $ 9,059 from deferred revenue.
−Removed: For the year ended December 31, 2017, the Company recognized $ 211,391 as license revenue within collaboration revenue in the Company’s consolidated statements of operations, and research and development revenue of $ 1,568 allocated from deferred revenue related to the BMS collaboration.
−Removed: Merck KGaA, Darmstadt Germany
−Removed: In 2013, the Company entered into a license agreement with Merck KGaA, Darmstadt Germany for lifirafenib, which was amended and restated in 2013 and 2015, in which it granted to Merck KGaA, Darmstadt Germany an exclusive license to develop, manufacture, and, in certain circumstances, commercialize lifirafenib outside of the PRC, and Merck KGaA Darmstadt Germany granted the Company an exclusive license to develop, manufacture and commercialize lifirafenib in the PRC (the “PRC Territory”).
−Removed: In March 2017, the Company regained the worldwide rights to lifirafenib after Merck KGaA, Darmstadt Germany informed the Company that it would not exercise a continuation option, and thus, the ex-PRC portion of the agreements terminated in their entirety, except for certain provisions that survived the termination.
−Removed: In December 2018, the Company received notice from Merck KGaA, Darmstadt Germany that Merck KGaA, Darmstadt Germany was terminating the PRC portion of the agreement.
−Removed: As a result of the termination, Merck KGaA, Darmstadt Germany's exclusive right of first negotiation to acquire exclusive commercialization rights under the lifirafenib RAF dimer program in the PRC was terminated and the Company is no longer required to pay Merck KGaA, Darmstadt Germany royalties on sales of lifirafenib in the PRC or entitled to receive future milestone payments from Merck KGaA, Darmstadt Germany for lifirafenib.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: Merck KGaA, Darmstadt Germany
+Added: In 2013, the Company entered into a license agreement with Merck KGaA, Darmstadt Germany for lifirafenib, which was amended and restated in 2013 and 2015, in which it granted to Merck KGaA, Darmstadt Germany an exclusive license to develop, manufacture, and, in certain circumstances, commercialize lifirafenib outside of the PRC, and Merck KGaA Darmstadt Germany granted the Company an exclusive license to develop, manufacture and commercialize lifirafenib in the PRC (the “PRC Territory”).
+Added: In March 2017, the Company regained the worldwide rights to lifirafenib after Merck KGaA, Darmstadt Germany informed the Company that it would not exercise a continuation option, and thus, the ex-PRC portion of the agreements terminated in their entirety, except for certain provisions that survived the termination.
+Added: In December 2018, the Company received notice from Merck KGaA, Darmstadt Germany that Merck KGaA, Darmstadt Germany was terminating the PRC portion of the agreement.
+Added: As a result of the termination, Merck KGaA, Darmstadt Germany's exclusive right of first negotiation to acquire exclusive commercialization rights under the lifirafenib RAF dimer program in the PRC was terminated and the Company is no longer required to pay Merck KGaA, Darmstadt Germany royalties on sales of lifirafenib in the PRC or entitled to receive future milestone payments from Merck KGaA, Darmstadt Germany for lifirafenib.
In 2013, the Company also entered into a license agreement with Merck KGaA, Darmstadt Germany for pamiparib, in which it granted to Merck KGaA, Darmstadt Germany an exclusive license to develop, manufacture, and, in certain circumstances, commercialize pamiparib outside of the PRC, and Merck KGaA, Darmstadt Germany granted the Company an exclusive license to develop, manufacture and commercialize pamiparib in the PRC Territory.
3 unchanged sentences
No other milestones were achieved prior to the termination of the agreement.
−Removed: On December 17, 2018, the Company entered into a letter agreement for the Company to buy back the PRC commercialization option for pamiparib that it had granted to Merck KGaA, Darmstadt Germany under the license agreement for initial consideration of $ 19,000 , which was paid in January 2019.
+Added: In December 2018, the Company entered into a letter agreement for the Company to buy back the PRC commercialization option for pamiparib that it had granted to Merck KGaA, Darmstadt Germany under the license agreement for initial consideration of $ 19,000 , which was paid in January 2019.
The payment was charged to research and development expense for the year ended December 31, 2018, as the PRC commercialization option has no alternative future use.
Merck KGaA, Darmstadt Germany was relieved of any future milestone obligations as a result of the termination.
+Added: In accordance with the letter agreement, the Company is required to pay a one-time milestone of $ 7,500 upon approval of pamiparib in the PRC.
+Added: All other future obligations were terminated.
As a result of the foregoing termination agreements and notices, the Company’s license agreements with Merck KGaA, Darmstadt Germany for lifirafenib and pamiparib were terminated in their entirety as of December 31, 2018.
In-Licensing Arrangements - Commercial
−Removed: Celgene Logistics Sàrl, a Bristol-Myers Squibb company ("BMS")
−Removed: On July 5, 2017, BeiGene and Celgene, now BMS, entered into a license and supply agreement pursuant to which BeiGene was granted the right to exclusively distribute and promote BMS's approved cancer therapies, ABRAXANE, REVLIMID, and VIDAZA in China, excluding Hong Kong, Macau and Taiwan (the “China License Agreement”).
−Removed: The China License Agreement became effective on August 31, 2017, contemporaneously with the closing of the acquisition of Celgene Shanghai and the A&R PD-1 License Agreement (see Note 4).
+Added: 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.
+Added: On January 2, 2020, following approval by the Company's shareholders and satisfaction of other closing conditions, the agreement became effective.
+Added: Under the agreement, the Company is responsible for the commercialization of XGEVA ® , KYPROLIS ® and BLINCYTO ® in China for five or seven years .
+Added: Amgen is responsible for manufacturing of the products globally and will supply the products to the Company at an agreed upon price.
+Added: The Company and Amgen will share equally in the China commercial profits and losses during the commercialization period.
+Added: Following the commercialization period, the Company has the right to retain one
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: product and is entitled to receive royalties on sales in China for an additional five years on the products not retained.
+Added: 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.
+Added: In July 2020, the Company began commercializing XGEVA ® in China.
+Added: In December 2020, BLINCYTO ® was approved in China for injection for the treatment of adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL).
+Added: Additionally, a new drug application has been filed in China for KYPROLIS ® as a treatment for patients with multiple myeloma.
+Added: Amgen and the Company are also jointly developing a portfolio of Amgen oncology pipeline assets under the collaboration.
+Added: 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 .
+Added: Amgen is responsible for all development, regulatory and commercial activities outside of China.
+Added: For each pipeline asset that is approved in China, the Company will receive commercial rights for seven years from approval.
+Added: The Company has the right to retain approximately one out of every three approved pipeline assets, other than sotorasib (AMG 510), Amgen's investigational KRAS G12C inhibitor, for commercialization in China.
+Added: The Company and Amgen will share equally in the China commercial profits and losses during the commercialization period.
+Added: 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.
+Added: The Company is also entitled to receive royalties from global sales of each product outside of China (with the exception of sotorasib).
+Added: 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.
+Added: 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.
+Added: Amounts due to Amgen for its portion of net product sales will be recorded as cost of sales.
+Added: Cost reimbursements due to or from Amgen under the profit share will be recognized as incurred and recorded to cost of sales;
+Added: selling, general and administrative expense;
+Added: or research and development expense, based on the underlying nature of the related activity subject to reimbursement.
+Added: Costs incurred for the Company's portion of the global co-development funding are recorded to research and development expense as incurred.
+Added: In connection with the Amgen Collaboration Agreement, a Share Purchase Agreement ("SPA") was entered into by the parties on October 31, 2019.
+Added: 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.
+Added: Per the SPA, the cash proceeds shall be used as necessary to fund the Company's development obligations under the Amgen Collaboration Agreement.
+Added: Pursuant to the SPA, Amgen also received the right to designate one member of the Company's board of directors, and Anthony Hooper joined the Company's board of directors as the Amgen designee in January 2020.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: The estimation of future cash flows involved management assumptions of revenue growth rates and probability of technical and regulatory success of the pipeline assets.
+Added: 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.
+Added: The cost share liability is being amortized proportionately as the Company contributes cash and development services to its total co-development funding cap.
+Added: Amounts recorded related to the cash proceeds received from the Amgen collaboration for the year ended December 31, 2020 were as follows:
+Added: Year Ended December 31, 2020
+Added: Fair value of equity issued to Amgen 2,162,407
+Added: Fair value of research and development cost share liability 616,834
+Added: Total cash proceeds 2,779,241
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: Amounts recorded related to the Company's portion of the co-development funding on the pipeline assets for the year ended December 31, 2020 were as follows:
+Added: Year Ended December 31, 2020
+Added: Research and development expense 117,005
+Added: Amortization of research and development cost share liability 113,986
+Added: Total amount due to Amgen for BeiGene's portion of the development funding 230,991
+Added: Total amount of development funding paid or payable in cash 224,396
+Added: Total amount of development funding paid with development services 6,595
+Added: As of December 31, 2020
+Added: Remaining portion of development funding cap 1,019,009
+Added: As of December 31, 2020, the research and development cost share liability recorded in the Company's balance sheet was as follows:
+Added: As of December 31, 2020
+Added: Research and development cost share liability, current portion 127,808
+Added: Research and development cost share liability, non-current portion 375,040
+Added: Total research and development cost share liability 502,848
+Added: The total reimbursement due under the commercial profit-sharing agreement for in-line product sales is classified in the income statement for the year ended December 31, 2020 as follows:
+Added: Year Ended December 31, 2020
+Added: Cost of sales - product ( 1,210 )
+Added: Selling, general and administrative ( 9,750 )
+Added: Research and development ( 660 )
+Added: Total ( 11,620 )
+Added: Celgene Logistics Sàrl, a BMS company
+Added: On July 5, 2017, BeiGene and Celgene Logistics Sàrl, now a BMS company, entered into a license and supply agreement pursuant to which BeiGene was granted the right to exclusively distribute and promote BMS's approved cancer therapies, ABRAXANE ® , REVLIMID ® , and VIDAZA ® in China, excluding Hong Kong, Macau and Taiwan (the “China License Agreement”).
+Added: The China License Agreement became effective on August 31, 2017, contemporaneously with the closing of the acquisition of Celgene Shanghai and the A&R PD-1 License Agreement.
The Company began distributing these in-licensed products in China in September 2017.
3 unchanged sentences
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.
−Removed: Upfront and development milestones paid under these arrangements for the years ended December 31, 2019, 2018 and 2017 are set forth below.
−Removed: All upfront and development milestones were expensed to research and development expense.
−Removed: There have been no regulatory or commercial milestones paid under these arrangements to date.
−Removed: Year Ended December 31,
−Removed: Research and development payments to Collaboration Partners
−Removed: Upfront payments
−Removed: Milestone payments
BEIGENE, LTD.
5 unchanged sentences
Our significant license agreements are described below:
−Removed: Seattle Genetics
−Removed: On November 5, 2019, the Company entered into a l icense agreement with Seattle Genetics, Inc.
−Removed: for an advanced pre-clinical product candidate for treating cancer.
−Removed: The agent utilizes a proprietary Seattle Genetics antibody-based technology.
−Removed: Under the terms of the agreement, Seattle Genetics retained rights to the product candidate in the Americas (United States, Canada and Latin American countries), Europe and Japan.
+Added: In January 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.
+Added: Under the terms of the agreement, EUSA granted the Company exclusive rights to SYLVANT ® in greater China and to QARZIBA ® in mainland China.
+Added: 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.
+Added: 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 .
+Added: EUSA will also be eligible to receive tiered royalties on future product sales.
+Added: The upfront payment was expensed to research and development expense during the year ended December 31, 2020 in accordance with the Company's acquired in-process research and development expense policy.
+Added: Assembly Biosciences, Inc.
+Added: In July 2020, the Company entered into a collaboration agreement with Assembly Biosciences, Inc.
+Added: ("Assembly") for Assembly's portfolio of three clinical-stage core inhibitor candidates for the treatment of patients with chronic hepatitis B virus ("HBV") infection in China.
+Added: Under the terms of the agreement, Assembly granted BeiGene exclusive rights to develop and commercialize ABI-H0731, ABI-H2158 and ABI-H3733 in China, including Hong Kong, Macau, and Taiwan.
+Added: BeiGene is responsible for development, regulatory submissions, and commercialization in China.
+Added: Assembly retains full worldwide rights outside of the partnered territory for its HBV portfolio.
+Added: Assembly received an upfront payment of $ 40,000 and is eligible to receive payments upon achievement of development, regulatory and commercial milestones up to a total of $ 503,750 .
+Added: Assembly is also eligible to receive tiered royalties on net sales.
+Added: The upfront payment was expensed to research and development expense during the year ended December 31, 2020 in accordance with the Company's acquired in-process research and development expense policy.
+Added: Bio-Thera Solutions, Ltd.
+Added: In August 2020, the Company entered into a license, distribution and supply agreement with Bio-Thera Solutions, Ltd.
+Added: ("Bio-Thera") for Bio-Thera's BAT1706, an investigational biosimilar to Avastin ® (bevacizumab) in China.
+Added: The agreement became effective on September 10, 2020 upon approval of Bio-Thera's shareholders, and was subsequently assigned by the Company to its affiliate BeiGene (Guangzhou) Co., Ltd.
+Added: ("BeiGene Guangzhou") on September 18, 2020, as permitted by the agreement.
+Added: Under the terms of the agreement, Bio-Thera agreed to grant BeiGene the right to develop, manufacture, and commercialize BAT1706 in China, including Hong Kong, Macau, and Taiwan.
+Added: Bio-Thera will retain rights outside of the partnered territory.
+Added: Bio-Thera received an upfront payment of $ 20,000 in October 2020 and is eligible to receive payments upon the achievement of regulatory and commercial milestones up to a total of $ 145,000 .
+Added: Bio-Thera will also be eligible to receive tiered double digit royalties on future net product sales.
+Added: The upfront payment was expensed to research and development expense during the year ended December 31, 2020 in accordance with the Company's acquired in-process research and development expense policy.
+Added: In November 2019, the Company entered into a l icense agreement with Seagen, Inc.
+Added: (formerly known as "Seattle Genetics, Inc.") for an advanced pre-clinical product candidate for treating cancer.
+Added: The agent utilizes a proprietary Seagen antibody-based technology.
+Added: Under the terms of the agreement, Seagen retained rights to the product candidate in the Americas (United States, Canada and Latin American countries), Europe and Japan.
The Company was granted exclusive rights to develop and commercialize the product candidate in Asia (except Japan) and the rest of the world.
−Removed: Seattle Genetics will lead global development and BeiGene will fund and operationalize the portion of global clinical trials attributable to its territories.
+Added: Seagen will lead global development and BeiGene will fund and operationalize the portion of global clinical trials attributable to its territories.
BeiGene will also be responsible for all clinical development and regulatory submissions specific to its territories.
−Removed: Seattle Genetics received an upfront payment of $ 20,000 and is eligible to receive progress-dependent milestones and tiered royalties on any product sales.
−Removed: Seattle Genetics is a related party due to a common shareholder, and that shareholder has different representatives serving on each companies' respective board of directors.
+Added: Seagen received an upfront payment of $ 20,000 and is eligible to receive progress-dependent milestones and tiered royalties on any product sales.
+Added: Seagen is a related party due to a common shareholder, and that shareholder has different representatives serving on each companies' respective board of directors.
The upfront payment was expensed to research and development expense during the year ended December 31, 2019 in accordance with the Company's acquired in-process research and development expense policy.
−Removed: On April 9, 2019, the Company entered into a global co-development and collaboration agreement with BioAtla LLC ("BioAtla") for the development, manufacturing and commercialization of BioAtla's investigational CAB-CTLA-4 antibody (BA3071), whereby BioAtla has agreed to co-develop the CAB-CTLA-4 antibody to defined early clinical objectives and the Company has agreed to then lead the parties' joint efforts to develop the product candidate and be responsible for global regulatory filings and commercialization.
−Removed: Subject to the terms of the agreement, the Company will hold a co-exclusive license with BioAtla to develop and manufacture the product candidate globally and an exclusive license to commercialize the product candidate globally.
−Removed: The Company has agreed to be responsible for all costs of development, manufacturing and commercialization in Asia (excluding Japan), Australia and New Zealand (the "Company Territory"), and the parties have agreed to share development and manufacturing costs and commercial profits and losses upon specified terms in the rest of the world.
−Removed: The Company paid BioAtla an upfront payment of $ 20,000 and BioAtla is eligible to receive a milestone payment upon reaching the defined early clinical objectives.
−Removed: BioAtla is also eligible to receive additional payments in subsequent development and regulatory milestones globally and commercial milestones in the Company Territory, together with tiered royalties on sales in the Company Territory.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: BioAtla, Inc.
+Added: In April 2019, the Company entered into a global co-development and collaboration agreement with BioAtla, Inc.
+Added: ("BioAtla") for the development, manufacturing and commercialization of BioAtla's investigational CAB-CTLA-4 antibody (BA3071), whereby BioAtla had agreed to co-develop the CAB-CTLA-4 antibody to defined early clinical objectives and the Company had agreed to then lead the parties' joint efforts to develop the product candidate and be responsible for global regulatory filings and commercialization.
+Added: Subject to the terms of the agreement, the Company held a co-exclusive license with BioAtla to develop and manufacture the product candidate globally and an exclusive license to commercialize the product candidate globally.
+Added: The Company had agreed to be responsible for all costs of development, manufacturing and commercialization in Asia (excluding Japan), Australia and New Zealand (the "Company Territory"), and the parties had agreed to share development and manufacturing costs and commercial profits and losses upon specified terms in the rest of the world.
+Added: The Company paid BioAtla an upfront payment of $ 20,000 and BioAtla was eligible to receive a milestone payment upon reaching the defined early clinical objectives.
+Added: BioAtla was also eligible to receive additional payments in subsequent development and regulatory milestones globally and commercial milestones in the Company Territory, together with tiered royalties on sales in the Company Territory.
The upfront payment was expensed to research and development expense during the year ended December 31, 2019 in accordance with the Company's acquired in-process research and development expense policy.
+Added: In October 2020, the Company and BioAtla amended the global co-development and collaboration agreement.
+Added: Under the amended terms of the agreement, BeiGene holds an exclusive global license to BA3071 and is solely responsible for its global clinical development and commercialization and has the right to receive all profits on any future sales, net of royalty payments to BioAtla.
+Added: In addition to the upfront payment BioAtla received upon execution of the original agreement, BioAtla is eligible to receive development and regulatory milestone payments together with increased tiered royalties on worldwide sales.
Zymeworks, Inc.
−Removed: On November 26, 2018, the Company and Zymeworks entered into collaboration and license agreements whereby the Company acquired licenses to develop and commercialize Zymeworks’ clinical-stage bispecific antibody candidate ZW25 and its preclinical-stage bispecific antibody drug conjugate ("ADC") ZW49 in Asia (excluding Japan), Australia, and New Zealand.
+Added: In November 2018, the Company and Zymeworks entered into collaboration and license agreements whereby the Company acquired licenses to develop and commercialize Zymeworks’ clinical-stage bispecific antibody candidate ZW25 and its preclinical-stage bispecific antibody drug conjugate ("ADC") ZW49 in Asia (excluding Japan), Australia, and New Zealand.
In addition, Zymeworks granted BeiGene a license to Zymeworks' proprietary Azymetric and EFECT platforms to develop and commercialize globally up to three other bispecific antibodies using the platforms.
6 unchanged sentences
In addition, Zymeworks will be eligible to receive tiered royalties on future global sales of bispecific products developed by BeiGene under the agreement.
+Added: The upfront payments were expensed to research and development expense during the year ended December 31, 2018 in accordance with the Company's acquired in-process research and development expense policy.
+Added: The Company recognized $ 15,000 of Zymeworks development milestone payments within research and development expense during the years ended December 31, 2020.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: The upfront payments were expensed to research and development expense during the year ended December 31, 2018 in accordance with the Company's acquired in-process research and development expense policy.
−Removed: No milestone payments were accrued as of December 31, 2019.
In addition to the collaborations discussed above, the Company has entered into additional collaborative arrangements during the years ending December 31, 2020 and 2019.
1 unchanged sentence
The Company may also incur significant research and development costs if the related product candidate were to advance to late-stage clinical trials.
−Removed: In addition, if any products related to these collaborations are approved for sale, the Company may be required to pay significant royalties on future sales.
+Added: In addition, if any products related to these collaborations are approved for sale, the Company may be required to pay significant milestones upon approval and milestones and/or 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.
−Removed: Business Combinations and Asset Acquisitions
−Removed: Celgene Shanghai
−Removed: On August 31, 2017, BeiGene HK acquired 100 % of the equity interests of Celgene Shanghai, a wholly-owned subsidiary of Celgene Holdings East Corporation established under the laws of the PRC.
−Removed: Celgene Shanghai was in the business of, among other things, providing marketing and promotional services in connection with certain pharmaceutical products manufactured by BMS.
−Removed: The name of Celgene Shanghai has been changed to BeiGene Pharmaceutical (Shanghai).
−Removed: On July 5, 2017, BeiGene and a wholly-owned subsidiary of BMS entered into a license agreement pursuant to which BeiGene was granted the right to exclusively distribute and promote BMS's approved cancer therapies, ABRAXANE, REVLIMID, and VIDAZA (the “Distribution Rights”), in China excluding Hong Kong, Macau and Taiwan (the “China License Agreement”).
−Removed: The China License Agreement became effective on August 31, 2017, contemporaneously with the closing of the acquisition of Celgene Shanghai and the A&R PD-1 License Agreement.
−Removed: The Company subsequently assigned the China License Agreement to its wholly-owned subsidiary, BeiGene Switzerland.
−Removed: The Company evaluated the acquisition of the Celgene Shanghai equity and the distribution rights acquired under ASU No.
−Removed: 2017-1, Business Combinations:
−Removed: Clarifying the Definition of a Business .
−Removed: Because substantially all of the value of the acquisition did not relate to a similar group of assets and the business contained both inputs and processes necessary to manage products and provide economic benefits directly to its owners, it was determined that the acquisition represents a business combination.
−Removed: Therefore, the transaction has been accounted for using the acquisition method of accounting.
−Removed: This method requires that assets acquired and liabilities assumed in a business combination be recognized at their fair values as of the acquisition date.
−Removed: Share subscription agreement
−Removed: On August 31, 2017, the Company issued 32,746,416 of its ordinary shares to BMS for an aggregate purchase price of $ 150,000 , or $ 4.58 per ordinary share, or $ 59.55 per ADS, pursuant to a subscription agreement dated July 5, 2017 by and between the Company and BMS (the “Share Subscription Agreement”).
−Removed: See Note 20 for further discussion of the Share Subscription Agreement.
−Removed: Determination of purchase price
−Removed: The purchase price of Celgene Shanghai was calculated as $ 28,138 , and was comprised of cash consideration of $ 4,532 and non-cash consideration of $ 23,606 , related to the discount on ordinary shares issued to BMS in connection with the Share Subscription Agreement.
−Removed: The discount was a result of the increase in fair value of the Company’s shares between the fixed price of $ 59.55 per ADS in the Share Subscription Agreement and the fair value per ADS as of the date of issuance, August 31, 2017.
−Removed: The following summarizes the purchase price in the business combination (in thousands).
−Removed: Purchase Price
−Removed: Cash paid to acquire Celgene Shanghai
−Removed: Discount on Share Subscription Agreement
−Removed: Total purchase price
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2019, 2018 AND 2017
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: Purchase price allocation
−Removed: The following table summarizes the fair values of assets acquired and liabilities assumed (in thousands):
−Removed: Cash and cash equivalents
−Removed: Other current assets
−Removed: Property and equipment, net
−Removed: Intangible assets
−Removed: Deferred tax asset
−Removed: Total identifiable assets
−Removed: Current liabilities
−Removed: Total liabilities assumed
−Removed: Total fair value of consideration transferred
−Removed: The goodwill resulting from the business combination is primarily attributable to the assembled workforce of the acquired business.
−Removed: The goodwill attributable to the business combination is not deductible for tax purposes.
−Removed: The following summarizes the business combination as presented on the statement of cash flows (in thousands):
−Removed: Investing activities
−Removed: Cash acquired
−Removed: Cash paid to acquire Celgene Shanghai
−Removed: Cash acquired in business combination, net of cash paid
−Removed: Non-cash activities
−Removed: Discount provided on sale of ordinary shares for business combination
+Added: Asset Acquisitions
BeiGene Pharmaceuticals (Guangzhou) Co., Ltd.
−Removed: On September 21, 2018, BeiGene (Guangzhou) Co., Ltd.
+Added: In September 2018, BeiGene (Guangzhou) Co., Ltd.
("BeiGene Guangzhou") acquired 100 % of the equity interests of Baiji Shenzhou (Guangzhou) Pharmaceuticals Co., Ltd.
3 unchanged sentences
Beijing Innerway Bio-tech Co., Ltd.
−Removed: On October 4, 2018, BeiGene HK completed the acquisition of 100 % of the equity interests of Beijing Innerway Bio-tech Co., Ltd., the owner of the Company's research, development and office facility in Changping, Beijing, China, for total cash consideration of $ 38,654 .
+Added: In October 2018, BeiGene HK completed the acquisition of 100 % of the equity interests of Beijing Innerway Bio-tech Co., Ltd., the owner of the Company's research, development and office facility in Changping, Beijing, China, for total cash consideration of $ 38,654 .
The acquisition was concentrated in a single identifiable asset or group of assets, the building and associated land use right, and thus the Company has concluded that the transaction is an asset acquisition as it does not meet the accounting definition of a business combination.
−Removed: The total cost of the transaction of $ 38,865 , which includes transaction costs
+Added: The total cost of the transaction of $ 38,865 , which includes transaction costs of $ 211 , was allocated based on the relative fair values of the net assets acquired, as follows:
+Added: Land use right 33,783
+Added: Building 15,874
+Added: Deferred tax liability ( 11,221 )
+Added: Total cost 38,865
+Added: Restricted Cash
+Added: The Company’s restricted cash balance of $ 8,055 and $ 2,764 as of December 31, 2020 and 2019, respectively, primarily consist of RMB-denominated cash deposits held in designated bank accounts for collateral for letters of credit.
+Added: The Company classifies restricted cash as current or non-current based on term of restriction.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: of $ 211 , was allocated based on the relative fair values of the net assets acquired, as follows:
−Removed: Land use right
−Removed: Deferred tax liability
−Removed: Restricted Cash
−Removed: The Company’s restricted cash balance of $ 2,764 as of December 31, 2019 primarily consists of RMB-denominated cash deposits held in designated bank accounts for collateral for letters of credit.
−Removed: The Company classifies restricted cash as current or non-current based on term of restriction.
Short-Term Investments
Short-term investments as of December 31, 2020 consisted of the following available-for-sale debt securities:
+Added: Losses Fair Value
(Net Carrying
treasury securities 3,267,875 850 — 3,268,725
+Added: Total 3,267,875 850 — 3,268,725
Short-term investments as of December 31, 2019 consisted of the following available-for-sale debt securities:
+Added: Losses Fair Value
(Net Carrying
treasury securities 363,440 1,288 — 364,728
+Added: Total 363,440 1,288 — 364,728
The Company does not consider the investments in U.S.
treasury securities to be other-than-temporarily impaired at December 31, 2020.
−Removed: The Company’s inventory balance of $ 28,553 and $ 16,242 as of December 31, 2019 and 2018 , respectively, consisted entirely of finished goods drug product purchased from BMS for distribution in the PRC.
−Removed: The manufacturing costs related to BRUKINSA inventory on hand as of December 31, 2019 were incurred prior to obtaining FDA approval on November 14, 2019, and expensed to research and development expense as incurred in accordance with the Company's pre-launch inventory policy.
−Removed: Manufacturing Facility in Guangzhou, China
−Removed: Manufacturing legal entity structure
−Removed: BeiGene Shanghai, originally established as a wholly-owned subsidiary of BeiGene HK, and currently a wholly-owned subsidiary of BeiGene Biologics, as described below, provides clinical development services for BeiGene affiliates and is the clinical trial authorization ("CTA") holder and marketing authorization application ("MAA") holder for tislelizumab in China.
−Removed: On March 7, 2017, BeiGene HK, a wholly owned subsidiary of the Company, and Guangzhou GET Technology Development Co., Ltd.
−Removed: (now Guangzhou High-tech Zone Technology Holding Group Co., Ltd.) ("GET"), entered into a
+Added: As of December 31, 2020, the Company's available-for-sale debt securities consisted entirely of short-term U.S.
+Added: treasury securities, which were determined to have zero risk of expected credit loss.
+Added: Accordingly, no allowance for credit loss was recorded as of December 31, 2020.
+Added: Equity Securities with Readily Determinable Fair Values
+Added: In January 2020, the Company purchased $ 5,000 of Series B mandatorily convertible, non-voting preferred stock of Leap in connection with a strategic collaboration and license agreement the Company entered into with Leap.
+Added: The Series B shares were subsequently converted into shares of Leap common stock and warrants to purchase additional shares of common stock upon approval of Leap's shareholders in March 2020.
+Added: As of December 31, 2020, the Company's ownership interest in the outstanding common stock of Leap was 8.1 % based on information from Leap.
+Added: Inclusive of the shares of common stock issuable upon the exercise of the currently exercisable warrants, the Company's interest is approximately 14.9 % based on information from Leap.
+Added: The Company measures the investment in the common stock and warrants at fair value, with changes in fair value recorded to other income, net.
+Added: The fair value of the common stock and warrants was $ 10,810 and $ 6,669 , respectively, as of December 31, 2020.
+Added: During the year ended December 31, 2020, the Company recorded an unrealized gain of $ 12,479 in the consolidated statement of operations.
+Added: Private Equity Securities without Readily Determinable Fair Values
+Added: The Company invests in equity securities of certain companies whose securities are not publicly traded and fair value is not readily determinable and where the Company has concluded it does not have significant influence based on its ownership percentage and other factors.
+Added: These investments are recorded at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.
+Added: The Company held investments of $ 9,705 and nil in equity securities without readily determinable fair values as of December 31, 2020 and December 31, 2019, respectively.
+Added: There were no adjustments to the carrying values of these securities for the year ended December 31, 2020.
+Added: Equity-Method Investments
+Added: In June 2019, the Company announced the formation of MapKure, an entity jointly owned by the Company and SpringWorks Therapeutics, Inc.
+Added: ("SpringWorks").
+Added: The Company out-licensed to MapKure the Company's product candidate
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: definitive agreement to establish a commercial scale biologics manufacturing facility in Guangzhou, Guangdong Province, PRC.
−Removed: On March 7, 2017, BeiGene HK and GET entered into an Equity Joint Venture Contract (the “JV Agreement”).
+Added: BGB-3245, an investigational oral, selective small molecule inhibitor of monomer and dimer forms of activating B-RAF mutations including V600 BRAF mutations, non-V600 B-RAF mutations, and RAF fusions.
+Added: The Company received 10,000,000 Series A preferred units of MapKure, or a 71.4 % ownership interest in exchange for its contribution of the intellectual property.
+Added: SpringWorks purchased 3,500,000 Series A preferred units, or a 25 % ownership interest, and other investors purchased 250,000 Series A preferred units or 1.8 % ownership each.
+Added: Following the initial closing, the Company consolidated its interests in MapKure under the voting model due to its controlling financial interest.
+Added: In June 2020, MapKure held a second closing under the existing terms of the SPA in which it issued additional Series A preferred units to SpringWorks and the other investors that purchased units in the first closing (the "Second Closing"), and the Company's ownership interest decreased to 55.6 %.
+Added: As the requisite Series A voting requirements in MapKure's governing documents require 70 % combined voting power for certain actions, the Company determined that it lost its controlling financial interest after the Second Closing.
+Added: Therefore, the Company deconsolidated MapKure and recognized a gain of $ 11,307 for the excess of the fair value of its 55.6 % ownership interest in MapKure and carrying amount of the prior non-controlling interest over the carrying amount of MapKure's net assets within other income during the year ended December 31, 2020.
+Added: Upon deconsolidation, the Company recorded an equity investment of $ 10,000 , which represents the estimated fair value of its 55.6 % ownership interest in MapKure.
+Added: Effective June 8, 2020, the Company is accounting for the investment as an equity-method investment and records its portion of MapKure's earnings or losses within other income, net.
+Added: The Company recognized losses of $ 491 for its portion of MapKure's net loss for the year ended December 31, 2020.
+Added: As of December 31, 2020, the carrying amount of the Company's investment in MapKure was $ 9,509 .
+Added: Guangzhou GET Phase I Biomedical Industry Investment Fund Partnership (Limited Partnership)
+Added: In July 2020, BeiGene (Guangzhou) invested $ 11,782 (RMB 80,000 ) in an existing investment fund, Guangzhou GET Phase I Biomedical Industry Investment Fund Partnership (Limited Partnership) (“GET Bio-fund”).
+Added: The stated purpose of GET Bio-fund is to promote and upgrade the local industrial transformation in Guangzhou and it is committed to invest at least 60 % of the total fund in the biotechnology, medical device, and medical information industries.
+Added: GET Bio-fund has four limited partners and one general partner, Guangzhou GET Biomedical Industry Investment Fund Management Co., Ltd.
+Added: (“GET Bio-fund Management”).
+Added: GET Bio-fund has an agreed duration for seven years , with the first five years as the investment period and the following two years as the projected payback period.
+Added: The agreed upon duration may be extended for two additional years with the approval of all of the partners.
+Added: BeiGene Guangzhou, as a limited partner, holds an ownership interest in the fund of 26.3 %.
+Added: The investment committee for the fund has seven members, and requires resolutions to be approved by at least five of the seven members.
+Added: BeiGene Guangzhou holds one position on the investment committee and GET Bio-fund Management holds three positions.
+Added: The Company determined that it has the ability to exercise significant influence over the fund due to the Company's ownership interest and involvement on the investment committee, and the investment represents an equity method investment.
+Added: The Company recognized losses of $ 68 for its portion of the fund's net loss for the year ended December 31, 2020.
+Added: As of December 31, 2020, the carrying amount of the Company's investment in the fund was $ 12,189 .
+Added: Other Equity-Method Investment
+Added: In addition to the equity-method investments mentioned above, the Company made an additional equity-method investment during the year ended December 31, 2020 that it does not consider to be individually significant to its financial statements.
+Added: The Company recognized the equity-method investment at cost and subsequently adjusted the basis based on the Company's share of the results of operations.
+Added: The Company records its share of the investee's results of operations within other income, net.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: The Company’s inventory balance consisted of the following:
+Added: As of December 31,
+Added: Raw materials 19,330 —
+Added: Work in process 1,378 —
+Added: Finished goods 68,585 28,553
+Added: Total inventories 89,293 28,553
+Added: Manufacturing Facility in Guangzhou, China
+Added: Manufacturing legal entity structure
+Added: BeiGene Shanghai, originally established as a wholly-owned subsidiary of BeiGene HK, and currently a wholly-owned subsidiary of BeiGene Biologics, as described below, provides clinical development services for BeiGene affiliates and is the clinical trial authorization ("CTA") holder and marketing authorization application ("MAA") holder for tislelizumab in China.
+Added: In March 2017, BeiGene HK, a wholly owned subsidiary of the Company, and Guangzhou GET Technology Development Co., Ltd.
+Added: (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.
+Added: 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.
3 unchanged sentences
("BeiGene Guangzhou Factory"), to manufacture biologics for the Company and its subsidiaries.
−Removed: On April 11, 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.
−Removed: On April 13, 2017 and May 4, 2017, BeiGene HK made cash capital contributions of RMB 137,830 and RMB 2,415 , respectively, into BeiGene Biologics.
−Removed: The remainder of the cash capital contribution from BeiGene HK to BeiGene Biologics was paid on June 27, 2019.
−Removed: On April 14, 2017, GET made cash capital contributions of RMB 100,000 into BeiGene Biologics.
−Removed: On April 14, 2017, BeiGene Biologics drew down the Shareholder Loan of RMB 900,000 from GET (as further described in Note 15).
−Removed: 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.
−Removed: 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.
+Added: BeiGene HK and BeiGene Biologics subsequently 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.
Upon the transfer of equity in BeiGene Shanghai, BeiGene HK's equity interest in BeiGene Shanghai became 95 %.
−Removed: As of December 31, 2019 , the Company and GET held 95 % and 5 % equity interests in BeiGene Biologics, respectively.
−Removed: As of December 31, 2019 , the Company had $ 123,706 of cash and cash equivalents and $ 1,995 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.
+Added: In September 2020, BeiGene HK entered into a share purchase agreement (“JV Share Purchase Agreement”) with GET to acquire GET’s 5 % equity interest in BeiGene Biologics for a total purchase price of $ 28,723 (RMB 195,262 ).
+Added: The transaction was finalized in November 2020 upon completion of the business registration filing.
+Added: The share purchase was recorded as an equity transaction.
+Added: The carrying amount of the noncontrolling interest balance of $ 9,116 was adjusted to nil to reflect the increase in BeiGene HK’s ownership interest to 100 %, and the difference in the fair value of the consideration paid and the carrying amount of the noncontrolling interest of $ 19,599 was recorded to additional paid in capital.
+Added: In connection with the JV Share Purchase Agreement, BeiGene Biologics repaid the outstanding principal of the Shareholder Loan of $ 132,061 (RMB 900,000 ) and accrued interest of $ 36,558 (RMB 249,140 ) (see Note 14).
+Added: In connection with the JV share purchase, the Company entered into a loan agreement with China Minsheng Bank for a total loan facility of up to $ 200,000 ("Senior Loan"), of which $ 120,000 was used to fund the JV share repurchase and repayment of the shareholder loan and $ 80,000 could be used for general working capital purposes.
+Added: The Company may extend the original maturity date for up to two additional twelve month periods.
+Added: In October 2020, the Company drew down $ 80,000 of the working capital facility and $ 118,320 of the acquisition facility to be used for the JV share repurchase.
+Added: In addition, the Company entered into a loan agreement with Zhuhai Hillhouse Zhaohui Equity Investment Partnership ("Zhuhai Hillhouse") for a total loan facility of $ 73,640 (RMB 500,000 ) ("Related Party Loan"), of which $ 14,728 (RMB 100,000 ) could be used for general corporate purposes and $ 58,912 (RMB 400,000 ) can only be applied towards the repayment of the Senior Loan facility,
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: including principal, interest and fees.
+Added: The Company has drawn down $ 14,728 (RMB 100,000 ) of the Related Party Loan as of December 31, 2020.
+Added: See Note 14 for further discussion of the loans.
Commercial distribution legal entity structure
BeiGene (Guangzhou) Co., Ltd.
−Removed: (“BGC”), a wholly-owned subsidiary of BeiGene HK, was organized on July 11, 2017.
−Removed: On September 21, 2018, BGC acquired 100 % of the equity interests of Baiji Shenzhou (Guangzhou) Pharmaceuticals Co., Ltd.
+Added: (“BGC”), a wholly-owned subsidiary of BeiGene HK, was organized in July 2017.
+Added: 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 owns drug distribution licenses necessary to distribute pharmaceutical products in China.
−Removed: The Company acquired these drug distribution licenses through the acquisition of BPG, which was accounted for as an asset acquisition (see Note 4), as it is difficult to obtain a newly issued domestic drug distribution license in China.
+Added: The Company acquired these drug distribution licenses through the acquisition of BPG, as it is difficult to obtain a newly issued domestic drug distribution license in China.
+Added: The transaction was accounted for as an asset acquisition (see Note 4).
Commercial supply agreement and facility expansion
4 unchanged sentences
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.
−Removed: Under the terms of the binding LOI, the Company provided initial funding for the facility expansion and may make additional payments for contingency costs.
−Removed: This initial funding payment and any subsequent contingency payments will be credited against future purchases of tislelizumab over the term of the supply agreement.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2019, 2018 AND 2017
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: 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.
+Added: Under the terms of the binding LOI, the Company provided initial funding for the facility expansion and made an additional payment for contingency costs in 2020.
+Added: These payments will be credited against future purchases of tislelizumab over the term of the supply agreement.
+Added: 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 term of the supply agreement.
The Company has operating leases for office and manufacturing facilities in the United States, Switzerland, and China.
2 unchanged sentences
A second Guangzhou land use right was acquired in May 2019 for potential expansion of the Company's research and development activities.
−Removed: The land use rights represent lease prepayments and are expensed over the remaining term of the rights, which is 48 years for the initial Guangzhou land use right, 50 years for the second Guangzhou land use right and 35 years for the Changping land use right.
+Added: The Company acquired a land use right in Suzhou in April 2020 to expand its research, development and manufacturing facility.
+Added: The land use rights represent lease prepayments and are expensed over the remaining term of the rights, which is 50 years for the initial Guangzhou land use right, 50 years for the second Guangzhou land use right, 36 years for the Changping land use right, and 30 years for the Suzhou land use right.
The Company also has certain leases with terms of 12 months or less for certain equipment, office and lab space, which are not recorded on the balance sheet.
The components of lease expense were as follows:
+Added: Year Ended December 31,
Operating lease cost 18,271 13,980
2 unchanged sentences
Total lease cost 21,754 16,765
−Removed: Total expenses under operating leases were $ 8,930 and $ 3,810 for the years ended December 31, 2018 and 2017, respectively.
−Removed: Supplemental balance sheet information related to leases was as follows:
−Removed: Operating lease right-of-use assets
−Removed: Land use rights, net
−Removed: Total operating lease right-of-use assets
−Removed: Current portion of operating lease liabilities
−Removed: Operating lease liabilities
−Removed: Total lease liabilities
+Added: Total expenses under operating leases were $ 8,930 for the year ended December 31, 2018.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: Supplemental balance sheet information related to leases was as follows:
+Added: As of December 31,
+Added: Operating lease right-of-use assets 41,850 35,555
+Added: Land use rights, net 48,731 46,965
+Added: Total operating lease right-of-use assets 90,581 82,520
+Added: Current portion of operating lease liabilities 13,895 10,814
+Added: Operating lease liabilities, non-current portion 29,417 25,833
+Added: Total lease liabilities 43,312 36,647
Maturities of operating lease liabilities are as follows:
4 unchanged sentences
Year ending December 31, 2025 668
+Added: Thereafter 255
Total lease payments 47,785
1 unchanged sentence
Present value of lease liabilities 43,312
−Removed: (1) As of December 31, 2019, the Company has additional operating leases for office facilities that have not yet commenced of $ 13,218 .
−Removed: These operating leases will commence during fiscal year 2020 with lease terms of up to five years .
Other supplemental information related to leases is summarized below:
+Added: Year ended December 31,
Operating cash flows used in operating leases 17,571 12,405
ROU assets obtained in exchange for new operating lease liabilities 17,634 20,108
+Added: As of December 31,
Weighted-average remaining lease term (years) 3 3
Weighted-average discount rate 6.26 % 7.07 %
−Removed: The undiscounted future minimum payments under non-cancelable operating leases as of December 31, 2018, prior to the adoption of the Lease ASUs was as follows:
−Removed: Year ending December 31:
−Removed: 2023 and thereafter
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: Property and Equipment
−Removed: Property and equipment are recorded at cost and consisted of the following:
+Added: Property, Plant and Equipment
+Added: Property, plant and equipment are recorded at cost less accumulated depreciation and consisted of the following:
As of December 31,
1 unchanged sentence
Leasehold improvements 37,643 24,008
+Added: Building 111,527 109,514
Manufacturing equipment 96,669 62,775
3 unchanged sentences
Construction in progress 85,779 20,955
−Removed: Property and equipment, net
−Removed: Construction in progress ("CIP") as of December 31, 2019 and 2018 of $ 20,955 and $ 99,487 , respectively, primarily related to the buildout of the Guangzhou manufacturing facility.
−Removed: Transfers out of CIP for the year ended December 31, 2019 primarily relate to assets placed into service upon completion of the initial phase of the Guangzhou manufacturing facility, which occurred in September 2019.
−Removed: Transfers out of CIP during the year ended December 31, 2019 and amounts remaining in CIP as of December 31, 2019 by fixed asset class are as follows:
−Removed: Transfers out of CIP
+Added: Property, plant and equipment, net 357,686 242,402
+Added: Construction in progress ("CIP") as of December 31, 2020 and 2019 primarily related to the buildout of additional capacity at the Guangzhou manufacturing facility.
+Added: CIP by fixed asset class are summarized as follows:
+Added: As of December 31,
+Added: Building 48,824 6,014
Manufacturing equipment 29,858 8,046
Laboratory equipment 4,507 4,496
−Removed: Subsequent phases of the Guangzhou factory buildout will continue to be recorded as CIP until they are placed into service.
+Added: Other 2,590 2,399
+Added: Total 85,779 20,955
Depreciation expense for the years ended December 31, 2020, 2019 and 2018 were $ 30,943 , $ 17,291 and $ 9,000 , respectively.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2019, 2018 AND 2017
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Intangible Assets
Intangible assets as of December 31, 2020 and December 31, 2019 are summarized as follows:
−Removed: December 31, 2019
−Removed: December 31, 2018
+Added: December 31, 2020 December 31, 2019
+Added: amount Accumulated
+Added: amortization Intangible
+Added: assets, net Gross
+Added: amount Accumulated
+Added: amortization Intangible
Finite-lived intangible assets:
2 unchanged sentences
Total finite-lived intangible assets 8,316 ( 3,316 ) 5,000 8,316 ( 2,470 ) 5,846
−Removed: Product distribution rights consist of distribution rights for the approved cancer therapies licensed from BMS, ABRAXANE, REVLIMID, and VIDAZA acquired as part of the BMS collaboration.
−Removed: The Company is amortizing the product distribution rights over a period of 10 years .
−Removed: The trading license represents the Guangzhou drug distribution license acquired on September 21, 2018.
−Removed: The Company is amortizing the drug distribution trading license over the remainder of the license term through February 2020.
−Removed: Amortization expense of intangible assets for the years ended December 31, 2019 , 2018 and 2017 was $ 1,326 , $ 894 and $ 250 , respectively.
−Removed: As of December 31, 2019 , expected amortization expense for the unamortized finite-lived intangible assets is approximately $ 846 in 2020, $ 750 in 2021, $ 750 in 2022, $ 750 in 2023, $ 750 in 2024, and $ 2,000 in 2025 and thereafter.
−Removed: The components of income ( loss) before income taxes are as follows:
−Removed: Year Ended December 31,
+Added: Product distribution rights consist of distribution rights for the approved cancer therapies licensed from BMS acquired as part of the BMS collaboration.
+Added: The Company is amortizing the product distribution rights over a period of 10 years from the date of acquisition.
+Added: The trading license represents the Guangzhou drug distribution license acquired in September 2018.
+Added: The Company amortized the drug distribution trading license over the remainder of the initial license term through February 2020.
+Added: The trading license has been renewed through February 2024.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: Amortization expense of intangible assets for the years ended December 31, 2020, 2019 and 2018 was $ 846 , $ 1,326 and $ 894 , respectively.
+Added: As of December 31, 2020, expected amortization expense for the unamortized finite-lived intangible assets is approximately $ 750 in 2021, $ 750 in 2022, $ 750 in 2023, $ 750 in 2024, $ 750 in 2025, and $ 1,250 in 2026 and thereafter.
+Added: The components of income ( loss) before income taxes are as follows:
+Added: Year Ended December 31,
+Added: 2020 2019 2018
+Added: PRC ( 369,066 ) ( 231,997 ) ( 130,552 )
+Added: 33,608 24,478 15,036
+Added: Other ( 1,282,736 ) ( 736,067 ) ( 574,313 )
+Added: Total ( 1,618,194 ) ( 943,586 ) ( 689,829 )
The current and deferred components of the income tax expense (benefit) from continuing operations are as follows:
Year Ended December 31,
+Added: 2020 2019 2018
Current Tax Expense (Benefit):
+Added: PRC 16,121 16,368 6,890
+Added: ( 5,678 ) 65 ( 377 )
+Added: Other 68 12 —
+Added: Total 10,511 16,445 6,513
Deferred Tax Expense (Benefit):
−Removed: Income Tax Expense (Benefit)
+Added: PRC ( 1,152 ) ( 4,738 ) ( 2,682 )
+Added: ( 27,030 ) ( 4,715 ) ( 19,627 )
+Added: Total ( 28,182 ) ( 9,453 ) ( 22,309 )
+Added: Income Tax (Benefit) Expense ( 17,671 ) 6,992 ( 15,796 )
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The reconciliation of the statutory tax rate to our effective income tax rate is as follow:
Year Ended December 31,
+Added: 2020 2019 2018
Loss before tax ( 1,618,194 ) ( 943,586 ) ( 689,829 )
5 unchanged sentences
Effect of tax rate change ( 3,827 ) ( 63,395 ) 1,538
−Removed: Deductible intellectual property from intercompany transfer
Change in valuation allowance 209,085 146,118 34,009
2 unchanged sentences
Effective tax rate 1.1 % ( 0.7 ) % 2.3 %
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2019, 2018 AND 2017
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Significant components of deferred tax assets (liabilities) are as follows:
Year Ended December 31,
+Added: 2020 2019 2018
Deferred Tax Assets:
9 unchanged sentences
Deferred tax liabilities:
−Removed: Depreciable and amortizable assets
Right of use lease asset ( 8,843 ) ( 7,480 ) —
5 unchanged sentences
Adjustments could be required in the future if the Company estimates that the amount of deferred tax assets to be realized is more or less than the net amount recorded.
−Removed: As of December 31, 2019 and 2018 , the Company had net operating losses of approximately $ 810,505 and $ 300,769 , respectively, of which net operating losses as of December 31, 2019 included $ 12,606 from an entity in Australia that has indefinite carryforward, $ 356,884 derived from entities in the PRC which expire in years 2020 through 2024, $ 383,914 derived from an entity in Switzerland that expires in 2026, and $ 57,101 derived from an entity in the United States that has indefinite carryforward.
+Added: As of December 31, 2020 and 2019 , the Company had net operating losses of approximately $ 2,230,857 and $ 810,505 , respectively, of which net operating losses as of December 31, 2020 included $ 20,773 from the Company's Australian
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: subsidiary, BeiGene AUS Pty Ltd., that has indefinite carryforward, $ 419,080 derived from certain of the Company's subsidiaries in the PRC which expire in years 2023 through 2030, $ 1,628,753 derived from BeiGene Switzerland GmbH that expires in years 2025 through 2027, and $ 162,251 derived from BeiGene USA, Inc.
+Added: that has indefinite carryforward.
The Company has approximately $ 63,597 of U.S.
−Removed: research tax credits which will expire between in 2036 and 2039 if not utilized.
+Added: research tax credits which will expire between 2035 and 2040 if not utilized.
The gross unrecognized tax benefits for the years ended December 31, 2020, 2019 and 2018 were as follows:
Year Ended December 31,
+Added: 2020 2019 2018
Beginning balance, as of January 1 4,633 2,295 918
4 unchanged sentences
Ending balance, as of December 31 7,123 4,633 2,295
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2019, 2018 AND 2017
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Current and prior year additions include assessment of U.S.
9 unchanged sentences
The Company qualifies for the Technology Advanced Service Enterprises (“TASE”) and High and New Technology Enterprise (“HNTE”) status for certain subsidiaries in China, which expire at the end of 2021.
−Removed: The income tax benefits attributable to this status for the year ended December 31, 2019 is approximately $ 2,600 or less than $ 0.01 per share outstanding.
−Removed: During the year ended December 31, 2019 , the Company completed intra-group transfers of certain intangible assets in anticipation of potential commercialization which resulted in the establishment of deferred tax assets that were fully offset by valuation allowances.
+Added: The income tax benefits attributable to this status for the year ended December 31, 2020 was approximately $ 1,614 , or less than $ 0.01 per share outstanding.
+Added: During the years ended December 31, 2020 and 2019, the Company completed intra-group transfers of certain intangible assets in anticipation of potential commercialization, which resulted in the establishment of deferred tax assets that were fully offset by valuation allowances.
As of December 31, 2020, the Company continues to assert indefinite reinvestment on the excess of the financial reporting bases over tax bases in the Company's investments in foreign subsidiaries.
1 unchanged sentence
Determination of the unrecognized deferred tax liability is not practicable due to uncertainty regarding the remittance structure and overall complexity of the hypothetical calculation.
−Removed: Supplemental Balance Sheet Information
−Removed: Prepaid expenses and other current assets consist of the following:
−Removed: As of December 31,
−Removed: Prepaid research and development costs
−Removed: Prepaid taxes
−Removed: Unbilled receivable
−Removed: Interest receivable
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: Supplemental Balance Sheet Information
+Added: Changes in the allowance for credit losses related to trade accounts receivable consist of the following:
+Added: Allowance for Credit Losses
+Added: Balance as of December 31, 2019 —
+Added: Provision charged to selling, general and administrative expenses 109
+Added: Amounts written-off, net of recoveries of amounts previously reserved —
+Added: Exchange rate changes 3
+Added: Balance as of December 31, 2020 112
+Added: Prepaid expenses and other current assets consist of the following:
+Added: As of December 31,
+Added: Prepaid research and development costs 71,341 65,886
+Added: Prepaid taxes 30,392 9,498
+Added: Payroll tax receivable 3,580 5,365
+Added: Non-trade receivable 4,464 —
+Added: Interest receivable 6,619 1,932
+Added: Prepaid insurance 1,347 711
+Added: Prepaid manufacturing cost 25,996 3,829
+Added: Income tax receivable 4,607 —
+Added: Other 11,666 3,017
+Added: Total 160,012 90,238
Other non-current assets consist of the following:
As of December 31,
+Added: Goodwill 109 109
Prepayment of property and equipment 16,984 10,289
Payment of facility capacity expansion activities (1) 29,778 24,881
+Added: Prepaid VAT 10,913 29,967
Rental deposits and other 5,962 3,209
−Removed: (1) Represents a payment for a facility expansion under a commercial supply agreement.
+Added: Long-term investments 49,344 —
+Added: Total 113,090 68,455
+Added: (1) Represents payments for a facility expansion under a commercial supply agreement.
The payment will provide future benefit to the Company through credits on future supply purchases as further described in Note 8.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Accrued expenses and other payables consisted of the following:
5 unchanged sentences
Sales rebates and returns related 11,874 3,198
+Added: Other 3,699 8,115
Total accrued expenses and other payables 346,144 163,556
1 unchanged sentence
As of December 31,
−Removed: Deferred revenue, non-current portion
Deferred government grant income 49,139 46,391
+Added: Pension liability 8,113 —
+Added: Other 177 171
Total other long-term liabilities 57,429 46,562
−Removed: Long-Term Bank Loan
−Removed: On September 2, 2015, BeiGene Suzhou entered into a loan agreement with Suzhou Industrial Park Biotech Development Co., Ltd.
−Removed: and China Construction Bank to borrow RMB 120,000 at a 7 % fixed annual interest rate.
−Removed: The loan was secured by BeiGene Suzhou's equipment and the Company's rights to a PRC patent on a drug candidate.
−Removed: In September 2018, the Company repaid the first tranche of $ 8,736 (RMB 60,000 ).
−Removed: In September 2019, the Company repaid the remaining principal outstanding of $ 8,394 (RMB 60,000 ).
−Removed: 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 benchmarking RMB loan interest rates of financial institutions in the PRC.
−Removed: The loan is secured by BeiGene Guangzhou Factory’s land use right.
−Removed: Interest expense will be paid quarterly until the loan is fully settled.
−Removed: As of December 31, 2019, the Company has fully drawn down $ 83,311 (RMB 580,000 ) of this loan.
−Removed: The loan interest rate was 4.9 % for the year ended December 31, 2019, and the maturity dates range from 2021 to 2027.
+Added: The following table summarizes the Company's short-term and long-term debt obligations as of December 31, 2020 and 2019:
+Added: Lender Agreement Date Line of Credit Term Maturity Date Interest Rate December 31, 2020 December 31, 2019
+Added: China Construction Bank April 4, 2018 RMB 580,000 9 -year
+Added: April 4, 2027 (1) 307 2,000 — —
+Added: China Minsheng Bank (the "Senior Loan") September 24, 2020 $ 200,000 (2) 5.8 % 198,320 1,294,010 — —
+Added: Zhuhai Hillhouse (the "Related Party Loan") September 24, 2020 RMB 500,000 (3) 5.8 % 15,326 100,000 — —
+Added: Other short-term debt (4) 121,062 789,918 — —
+Added: Total short-term debt 335,015 2,185,928 — —
+Added: China Construction Bank April 4, 2018 RMB 580,000 9 -year
+Added: April 4, 2027 (1) 88,584 578,000 83,311 580,000
+Added: Industrial Bank Co.
+Added: September 3, 2019 RMB 348,000 3 -year
+Added: (5) 4.9 % — — — —
+Added: China Merchants Bank January 22, 2020 (6) 9 -year
+Added: January 20, 2029 (6) 53,641 350,000 — —
+Added: China Merchants Bank November 9, 2020 RMB 378,000 9 -year
+Added: November 8, 2029 (7) 41,412 270,206 — —
+Added: Total long-term bank loans 183,637 1,198,206 83,311 580,000
+Added: GET (the "Shareholder Loan") March 7, 2017 RMB 900,000 (8) September 28, 2020 8.0 % — — 157,384 900,000
+Added: Shareholder loan — — 157,384 900,000
+Added: The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC.
+Added: The loan interest rate was 4.9 % as of December 31, 2020.
+Added: The loan is secured by BeiGene Guangzhou Factory's land use right and certain Guangzhou Factory fixed assets in the first phase of the Guangzhou manufacturing facility's build out.
+Added: $ 120,000 of the Senior Loan was designated to fund the JV share purchase and repayment of the shareholder loan and $ 80,000 was designated for general working capital purposes.
+Added: The Senior Loan has an original maturity date of October 8, 2021, which is the first anniversary of the first date of utilization of
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: On September 3, 2019, BeiGene Shanghai entered into a three -year working capital loan facility with Industrial Bank Co., Ltd.
−Removed: ("Industrial Bank") to borrow up to RMB 348,000 at a floating interest rate benchmarked against prevailing interest rates of certain PRC financial institutions.
−Removed: The loan facility was secured with RMB deposited at Industrial Bank and the loan interest rate was 4.85 % .
−Removed: Interest expense was payable quarterly until the loan was fully settled.
+Added: The Company may extend the original maturity date for up to two additional twelve month periods.
+Added: On October 9, 2020, the Company drew down $ 80,000 of the working capital facility and $ 118,320 of the acquisition facility to fund the JV share repurchase.
+Added: RMB 100,000 of the Related Party Loan was designated for general corporate purposes and RMB 400,000 was designated for repayment of the Senior Loan, including principal, interest and fees.
+Added: The loan matures at the earlier of:
+Added: (i) November 9, 2021, which is one month after the Senior Loan maturity date, if not extended, or (ii) 10 business days after the Senior Loan is fully repaid.
+Added: On September 30, 2020, the Company drew down the first tranche of $ 14,728 (RMB 100,000 ).
+Added: Zhuhai Hillhouse is a related party of the Company, as it is an affiliate of Hillhouse Capital.
+Added: Hillhouse Capital is a shareholder of the Company, and a Hillhouse Capital employee is a member of the Company's board of directors.
+Added: During the year ended December 31, 2020, the Company entered into additional short-term working capital loans with China Industrial Bank and China Merchants Bank to borrow up to RMB 1,480,000 in aggregate, with maturity dates ranging from April 19, 2021 to December 16, 2021.
+Added: The Company drew down $ 129,937 (RMB 869,918 ) during the year ended December 31, 2020.
+Added: The weighted average interest rate for the short-term working capital loans was approximately 4.4 % as of December 31, 2020.
+Added: One of the short-term working capital loans in the amount of $ 26,510 (RMB 180,000 ) is secured by the Company's research and development facility in Beijing and the associated land use right owned by its subsidiary, Beijing Innerway Bio-tech Co., Ltd.
+Added: The loan facility was secured with RMB deposited at Industrial Bank.
In December 2019, the Company repaid the outstanding principal of $ 24,419 (RMB 170,000 ).
−Removed: Interest expense recognized for the years ended December 31, 2019 , 2018 and 2017 amounted to $ 4,732 , $ 2,253 and $ 1,260 , respectively, among which, $ 2,412 , $ 575 and nil was capitalized, respectively.
−Removed: Shareholder Loan
−Removed: On March 7, 2017, BeiGene Biologics entered into the Shareholder Loan Contract with GET, pursuant to which GET agreed to provide the Shareholder Loan of RMB 900,000 to BeiGene Biologics.
−Removed: The Shareholder Loan has a conversion feature, settled in a variable number of shares of common stock upon conversion (the “debt-to-equity conversion”).
+Added: On January 22, 2020, BeiGene Guangzhou Factory entered into a nine-year bank loan with China Merchants Bank to borrow up to RMB 1,100,000 at a floating interest rate benchmarked against prevailing interest rates of certain PRC financial institutions.
+Added: The loan is secured by Guangzhou Factory's second land use right and fixed assets that will be placed into service upon completion of the second phase of the Guangzhou manufacturing facility's build out.
+Added: In connection with the Company's short-term loan agreements with China Merchants Bank entered into during the year ended December 31, 2020, the borrowing capacity was reduced from RMB 1,100,000 to RMB 350,000 .
+Added: The loan interest rate was 4.4 % as of December 31, 2020.
+Added: The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC.
+Added: The loan interest rate was 4.3 % as of December 31, 2020.
+Added: The loan is secured by fixed assets that will be placed into service upon completion of the third phase of the Guangzhou manufacturing facility's build out.
+Added: The Shareholder Loan had 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.
−Removed: Key features of the Shareholder Loan
−Removed: The Shareholder Loan bears simple interest at a fixed rate of 8 % per annum.
−Removed: No interest payment is due or payable prior to the repayment of the principal or the debt-to-equity conversion.
−Removed: 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.
−Removed: 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.
−Removed: BeiGene Biologics has the right to make early repayment at any time;
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: If BeiGene Biologics does not use the Shareholder Loan proceeds for the specified purposes, GET may be entitled to certain liquidated damages.
−Removed: 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.
−Removed: Accounting for the Shareholder Loan
−Removed: The Shareholder Loan is classified as a long-term liability and initially measured at the principal of RMB 900,000 .
−Removed: Interest will be accrued based on the interest rate of 8 % per annum.
−Removed: 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.
−Removed: This in-substance redemption feature does not require bifurcation because it is clearly and closely related to the debt host that does not involves a substantial premium or discount.
−Removed: Since there is no conversion feature embedded in the Shareholder Loan, no beneficial conversion feature was recorded.
−Removed: There are no other embedded derivatives that are required to be bifurcated.
−Removed: 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.
−Removed: For the years ended December 31, 2019 , 2018 and 2017 , total interest expense generated from the Shareholder Loan was $ 10,423 , $ 10,894 and $ 7,649 , respectively, among which, $ 2,445 , $ 3,112 and $ 614 was capitalized, respectively.
+Added: On September 28, 2020, BeiGene HK entered into the JV Share Purchase Agreement with GET to acquire GET’s 5 % equity interest in BeiGene Biologics (see Note 8).
+Added: In connection with the JV Share Purchase Agreement, BeiGene Biologics repaid the outstanding principal amount of the Shareholder Loan of $ 132,061 (RMB 900,000 ) and accrued interest of $ 36,558 (RMB 249,140 ) on September 28, 2020.
+Added: Contractual Maturities of Debt Obligations
+Added: The aggregate contractual maturities of all borrowings due subsequent to December 31, 2020 are as follows:
+Added: Maturity dates Amounts
+Added: Year ending December 31, 2021 335,015
+Added: Year ending December 31, 2022 2,759
+Added: Year ending December 31, 2023 12,260
+Added: Year ending December 31, 2024 28,025
+Added: Year ending December 31, 2025 35,081
+Added: Thereafter 105,512
+Added: Total 518,652
+Added: Interest Expense
+Added: Interest on bank loans and the Related Party Loan is paid quarterly until the respective loans are fully settled.
+Added: Interest expense recognized for the years ended December 31, 2020, 2019 and 2018 amounted to $ 18,309 , $ 15,155 and $ 13,147 , respectively, among which, $ 338 , $ 4,857 and $ 3,687 was capitalized, respectively.
Product Revenue
−Removed: The Company’s product sales are derived from the sale of ABRAXANE, REVLIMID, and VIDAZA in China under a distribution license from BMS.
−Removed: Following FDA approval on November 14, 2019, the Company launched its first internally developed drug, BRUKINSA, and began generating product revenues in the United States.
+Added: The Company’s product revenue is derived from the sale of its internally developed products BRUKINSA ® in the United States and China and tislelizumab in China, as well as the sale of REVLIMID ® , VIDAZA ® and ABRAXANE ® in China under a license from BMS and XGEVA ® in China under a license from Amgen.
+Added: On March 25, 2020, the Company announced that the
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: NMPA suspended the importation, sales and use of ABRAXANE ® in China supplied to BeiGene by Celgene, a BMS company, and the drug was subsequently recalled by BMS and is not currently available for sale in China.
The table below presents the Company’s net product sales for the years ended December 31, 2020, 2019 and 2018.
+Added: Year Ended December 31,
+Added: 2020 2019 2018
Product revenue - gross 324,672 228,760 138,046
1 unchanged sentence
Product revenue - net 308,874 222,596 130,885
−Removed: The following table presents the rollforward of accrued sales rebates and returns for the years ended December 31, 2019 and December 31, 2018 .
+Added: The following table disaggregates net product revenue by product for the years ended December 31, 2020, 2019 and 2018.
+Added: Year Ended December 31,
+Added: 2020 2019 2018
+Added: Tislelizumab 163,358 — —
+Added: 41,702 1,039 —
+Added: 47,372 78,044 55,412
+Added: 29,975 32,234 4,234
+Added: 17,770 111,279 71,239
+Added: Other 201 — —
+Added: Total product revenue - net 308,874 222,596 130,885
+Added: The following table presents the roll-forward of accrued sales rebates and returns for the years ended December 31, 2020 and December 31, 2019.
Sales Rebates and Returns
Balance as of December 31, 2018 4,749
+Added: Accrual 6,164
+Added: Payment ( 7,715 )
Balance as of December 31, 2019 3,198
+Added: Accrual 15,798
+Added: Payment ( 7,122 )
Balance as of December 31, 2020 11,874
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Loss Per Share
1 unchanged sentence
Year Ended December 31,
+Added: 2020 2019 2018
Net loss attributable to BeiGene, Ltd.
+Added: ( 1,596,906 ) ( 948,628 ) ( 673,769 )
Weighted average shares outstanding for computing basic and diluted loss per share 1,085,131,783 780,701,283 720,753,819
4 unchanged sentences
2016 Share Option and Incentive Plan
−Removed: On January 14, 2016, in connection with its U.S.
−Removed: IPO, the board of directors and shareholders of the Company approved the 2016 Share Option and Incentive Plan (the “2016 Plan”), which became effective on February 2, 2016.
+Added: In January 2016, in connection with its U.S.
+Added: IPO, the board of directors and shareholders of the Company approved the 2016 Share Option and Incentive Plan (the “2016 Plan”), which became effective in February 2016.
The Company initially reserved 65,029,595 ordinary shares for the issuance of awards under the 2016 Plan, plus any shares available under the 2011 Option Plan (the “2011 Plan”), and not subject to any outstanding options as of the effective date of the 2016 Plan, along with underlying share awards under the 2011 Plan that are cancelled or forfeited without issuance of ordinary shares.
−Removed: As of December 31, 2019 , ordinary shares cancelled or forfeited under the 2011 Plan that were carried over to the 2016 Plan
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2019, 2018 AND 2017
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: totaled 5,152,236 .
+Added: As of December 31, 2020, ordinary shares cancelled or forfeited under the 2011 Plan that were carried over to the 2016 Plan totaled 1,832,415 .
The 2016 Plan 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.
On January 1, 2018, 29,603,616 ordinary shares were added to the 2016 Plan under this provision.
−Removed: In August 2018, in connection with the Hong Kong IPO, 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 Hong Kong Stock Exchange ("HKEx") rules.
+Added: However, in August 2018, in connection with the Hong Kong IPO, 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 Hong Kong Stock Exchange ("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.
+Added: In June 2020, the shareholders approved an Amendment No.
+Added: 1 to the 2016 Plan to increase the number of shares authorized for issuance by 57,200,000 ordinary shares and to extend the term of the plan through April 13, 2030.
The number of shares available for issuance under the 2016 Plan is subject to adjustment in the event of a share split, share dividend or other change in the Company’s capitalization.
1 unchanged sentence
2018 Inducement Equity Plan
−Removed: 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.
+Added: In June 2018, the board of directors of the Company approved the 2018 Inducement Equity Plan (the “2018 Plan”) and reserved 12,000,000 ordinary shares to be used exclusively for grants of awards to individuals who 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.
−Removed: In August 2018, in connection with the listing of the Company’s ordinary shares on the HKEx, the board of directors of the Company approved an amended and restated 2018 Plan to implement changes required by the HKEx rules.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: August 2018, in connection with the listing of the Company’s ordinary shares on the HKEx, the board of directors of the Company approved an amended and restated 2018 Plan to implement changes required by the HKEx rules.
As of December 31, 2020, share-based awards to acquire 9,103,756 ordinary shares were available for future grant under the 2018 Plan.
2018 Employee Share Purchase Plan
−Removed: On June 6, 2018, the shareholders of the Company approved the 2018 Employee Share Purchase Plan (the “ESPP”).
+Added: In June 2018, the shareholders of the Company approved the 2018 Employee Share Purchase Plan (the “ESPP”).
Initially, 3,500,000 ordinary shares of the Company were reserved for issuance under the ESPP.
3 unchanged sentences
Eligible employees are able to authorize payroll deductions of up to 10 % of their eligible earnings, subject to applicable limitations.
−Removed: On February 28, 2019, the Company issued 154,505 ordinary shares to employees for aggregate proceeds of $ 1,385 under the ESPP.
−Removed: 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.
−Removed: On August 30, 2019, the Company issued 233,194 ordinary shares to employees for aggregate proceeds of $ 2,192 under the ESPP.
−Removed: 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.
+Added: The following tables summarizes the shares issued under the ESPP:
+Added: Market Price 1
+Added: Purchase Price 2
+Added: Issuance Date Number of Ordinary Shares Issued ADS Ordinary ADS Ordinary Proceeds
+Added: August 31, 2020 485,069 $ 164.06 $ 12.62 $ 139.45 $ 10.73 $ 5,203
+Added: February 28, 2020 425,425 $ 145.54 $ 11.20 $ 123.71 $ 9.52 $ 4,048
+Added: August 30, 2019 233,194 $ 143.75 $ 11.06 $ 122.19 $ 9.40 $ 2,192
+Added: February 28, 2019 154,505 $ 137.05 $ 10.54 $ 116.49 $ 8.96 $ 1,385
+Added: 1 The market price is the lower of the closing price on the NASDAQ Stock Market on the issuance date or the offering date, in accordance with the terms of the ESPP.
+Added: 2 The purchase price is the price which was discounted from the applicable market price, in accordance with the terms of the ESPP.
As of December 31, 2020, 6,056,056 ordinary shares were available for future issuance under the ESPP.
+Added: Share options
+Added: Generally, share options have a contractual term of 10 years and vest over a three - to five-year period, with the first tranche vesting one calendar year after the grant date or the service relationship start date and the remainder of the awards vesting on a monthly basis thereafter.
+Added: Restricted shares and restricted share units generally vest over a four-year period, with the first tranche vesting one calendar year after the grant date or the service relationship start date and the remainder of the awards vesting on a yearly basis thereafter, or sometimes vest upon the achievement of pre-specified performance conditions.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: Share options
−Removed: Generally, options have a contractual term of 10 years and vest over a three - to five -year period, with the first tranche vesting one calendar year after the grant date or the service relationship start date and the remainder of the awards vesting on a monthly basis thereafter.
−Removed: Restricted shares and restricted share units vest over a four -year period, with the first tranche vesting one calendar year after the grant date or the service relationship start date and the remainder of the awards vesting on a yearly basis thereafter.
The following table summarizes the Company’s share option activities under the 2011, 2016 and 2018 Plans:
+Added: Options Weighted
+Added: Price Weighted
+Added: Value Weighted
+Added: Term Aggregate
Intrinsic Value
Outstanding at December 31, 2017 127,002,897 2.45
+Added: Granted 9,387,885 12.32 7.08
+Added: Exercised ( 13,841,036 ) 2.23 132,687
+Added: Forfeited ( 6,467,099 ) 3.59
Outstanding at December 31, 2018 116,082,647 3.21
+Added: Granted 12,641,590 9.38 5.06
+Added: Exercised ( 16,730,441 ) 2.60 171,429
+Added: Forfeited ( 3,576,542 ) 5.09
Outstanding at December 31, 2019 108,417,254 3.96
+Added: Granted 8,999,536 13.54 7.15
+Added: Exercised ( 29,707,587 ) 2.82 416,509
+Added: Forfeited ( 2,717,488 ) 7.22
Outstanding at December 31, 2020 84,991,715 5.27 6.45 1,242,276
12 unchanged sentences
Treasury Bills yield curve in effect at the time of grant.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2019, 2018 AND 2017
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: The following table presents the assumptions used to estimate the fair values of the share options granted in the years presented:
+Added: The following table presents the range of fair values and the assumptions used to estimate those fair values of the share options granted in the years presented:
Year Ended December 31,
−Removed: Fair value of ordinary share
2020 2019 2018
+Added: Fair value of ordinary share $ 4.95 ~ $ 11.89
$ 4.64 ~ $ 8.28
1 unchanged sentence
Risk-free interest rate 0.6 % ~ 1.1 %
+Added: 1.5 % ~ 2.8 %
+Added: 2.5 % ~ 3.1 %
Expected exercise multiple 2.8
1 unchanged sentence
Expected dividend yield 0 % 0 % 0 %
−Removed: Contractual life
+Added: Contractual life 10 years 10 years 10 years
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Restricted shares
The following table summarizes the Company’s restricted share activities under the 2016 Plan:
−Removed: Weighted-Average
+Added: of Shares Weighted-Average
Grant Date Fair Value
Outstanding at December 31, 2017 806,250 2.16
+Added: Vested ( 387,500 ) 2.12
+Added: Forfeited ( 118,750 ) 2.04
Outstanding at December 31, 2018 300,000 2.25
+Added: Vested ( 75,000 ) 2.27
+Added: Forfeited ( 150,000 ) 2.24
Outstanding at December 31, 2019 75,000 2.27
+Added: Vested ( 75,000 ) 2.27
+Added: Forfeited — —
Outstanding at December 31, 2020 — —
1 unchanged sentence
The Company had no non-employee restricted share activities during the year ended December 31, 2020.
−Removed: As of December 31, 2019 , the unrecognized compensation cost related to unvested restricted shares expected to vest was $ 153 .
−Removed: This unrecognized compensation will be recognized over an estimated weighted-average amortization period of 0.7 years .
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2019, 2018 AND 2017
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
+Added: As of December 31, 2020, all compensation cost related to restricted shares was fully recognized.
Restricted share units
The following table summarizes the Company's restricted share unit activities under the 2016 and 2018 Plans:
−Removed: Weighted-Average
+Added: of Shares Weighted-Average
Grant Date Fair Value
Outstanding at December 31, 2017 1,469,442 7.55
+Added: Granted 14,079,598 12.07
+Added: Vested ( 689,130 ) 8.33
+Added: Forfeited ( 757,458 ) 10.89
Outstanding at December 31, 2018 14,102,452 11.85
+Added: Granted 18,637,333 10.10
+Added: Vested ( 3,474,068 ) 11.75
+Added: Forfeited ( 2,413,450 ) 11.07
Outstanding at December 31, 2019 26,852,267 10.72
+Added: Granted 18,820,581 14.20
+Added: Vested ( 7,302,828 ) 10.88
+Added: Forfeited ( 3,493,048 ) 11.36
Outstanding at December 31, 2020 34,876,972 12.50
2 unchanged sentences
This unrecognized compensation will be recognized over an estimated weighted-average amortization period of 3.2 years.
−Removed: The following table summarizes total share-based compensation cost recognized for the years ended December 31, 2019 , 2018 and 2017 :
−Removed: Year Ended December 31,
−Removed: Research and development
−Removed: Selling, general and administrative
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: Accumulated Other Comprehensive (Loss) Income
−Removed: The movement of accumulated other comprehensive (loss) income is as follows:
+Added: The following table summarizes total share-based compensation cost recognized for the years ended December 31, 2020, 2019 and 2018:
+Added: Year Ended December 31,
+Added: 2020 2019 2018
+Added: Research and development 92,999 76,293 54,384
+Added: Selling, general and administrative 90,482 57,861 32,743
+Added: Total 183,481 134,154 87,127
+Added: Accumulated Other Comprehensive Income (Loss)
+Added: The movement of accumulated other comprehensive income (loss) was as follows:
Foreign Currency
+Added: Adjustments Unrealized
Gains/Losses on
Available-for-Sale
−Removed: December 31, 2017
−Removed: Adjustment for the opening balance of accumulated other comprehensive loss
−Removed: January 1, 2018
−Removed: Other comprehensive (loss) income before reclassifications
−Removed: Amounts reclassified from accumulated other comprehensive loss
−Removed: Net-current period other comprehensive (loss) income
+Added: Securities Pension Liability Adjustments Total
December 31, 2018 ( 212 ) 1,738 — 1,526
−Removed: Other comprehensive (loss) income before reclassifications
−Removed: Amounts reclassified from accumulated other comprehensive loss
+Added: Other comprehensive income (loss) before reclassifications ( 9,079 ) 5,596 — ( 3,483 )
+Added: Amounts reclassified from accumulated other comprehensive income (loss) (1) — ( 6,044 ) — ( 6,044 )
Net-current period other comprehensive loss ( 9,079 ) ( 448 ) — ( 9,527 )
December 31, 2019 ( 9,291 ) 1,290 — ( 8,001 )
+Added: Other comprehensive income (loss) before reclassifications 23,475 1,073 ( 8,113 ) 16,435
+Added: Amounts reclassified from accumulated other comprehensive income (loss) (1) — ( 1,492 ) — ( 1,492 )
+Added: Net-current period other comprehensive (loss) income 23,475 ( 419 ) ( 8,113 ) 14,943
+Added: December 31, 2020 14,184 871 ( 8,113 ) 6,942
+Added: (1) The amounts reclassified from accumulated other comprehensive (loss) income were included in other income, net in the consolidated statements of operations.
Shareholders’ Equity
−Removed: Follow-on public offerings
−Removed: During the years ended December 31, 2019, 2018 and 2017, the Company completed the following follow-on public offerings:
−Removed: On August 16, 2017, the Company completed a follow-on public offering at a price of $ 71.00 per ADS, or $ 5.46 per ordinary share.
−Removed: In this offering, the Company sold 2,465,000 ADSs representing 32,045,000 ordinary shares.
−Removed: Additionally, the underwriters exercised their option to purchase an additional 369,750 ADSs representing 4,806,750 ordinary shares from the Company.
−Removed: Net proceeds from this offering, including the underwriter option, after deducting the underwriting discounts and offering expenses, were $ 188,517 .
−Removed: On January 22, 2018, the Company completed a follow-on public offering under the Company’s effective registration statement on Form S-3 at a price of $ 101.00 per ADS, or $ 7.77 per ordinary share.
+Added: During the years ended December 31, 2020, 2019 and 2018, the Company completed the following equity offerings:
+Added: In January 2018, the Company completed a follow-on public offering under the Company’s effective registration statement on Form S-3 at a price of $ 101.00 per ADS, or $ 7.77 per ordinary share.
In this offering, the Company sold 7,425,750 ADSs representing 96,534,750 ordinary shares.
Additionally, the underwriters exercised their option to purchase an additional 495,050 ADSs representing 6,435,650 ordinary shares from the Company.
−Removed: Net proceeds from this offering, including the underwriter option, after deducting the underwriting discounts and offering expenses, were $ 757,587 .
−Removed: On August 8, 2018, the Company completed an initial public offering of its ordinary shares on The Hong Kong Stock Exchange Limited and a follow-on public offering of its ADS on the NASDAQ Global Select Market under the Company's effective registration statement on Form S-3 at a price of $ 13.76 per ordinary share, or $ 178.90 per ADS.
+Added: Net proceeds from this offering, including the underwriter option, after deducting the underwriting discounts and offering expenses of $ 42,413 , were $ 757,587 .
+Added: In August 2018, the Company completed an initial public offering of its ordinary shares on The Hong Kong Stock Exchange Limited and a follow-on public offering of its ADS on the NASDAQ Global Select Market under the Company's effective registration statement on Form S-3 at a price of $ 13.76 per ordinary share, or $ 178.90 per ADS.
In this offering, the Company sold 65,600,000 ordinary shares.
−Removed: Net proceeds after deducting underwriting discounts and commissions and offering expenses were $ 869,709 .
−Removed: Share Subscription Agreement
−Removed: On August 31, 2017, the Company sold 32,746,416 of its ordinary shares to BMS for an aggregate cash price of $ 150,000 , or $ 4.58 per ordinary share, or $ 59.55 per ADS, pursuant to a Share Subscription Agreement in connection with the entry into the A&R PD-1 License Agreement.
−Removed: Proceeds from the issuance are recorded net of $ 72 of fees related to the share issuance.
−Removed: The offer and sale of the shares issued pursuant to the Share Subscription Agreement was made in a private placement in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act, for transactions by an issuer not involving a public offering, and/or Regulation D under the Securities Act.
+Added: Net proceeds, after deducting underwriting discounts and commissions and offering expenses of $ 32,947 , were $ 869,709 .
+Added: In January 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.
+Added: On March 17, 2020, BeiGene, Ltd.
+Added: and Amgen entered into an Amendment No.
+Added: 2 (the “Second Amendment”) to the Share Purchase Agreement in order to account for periodic dilution from the issuance of shares by the
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: Company, which was restated in its entirety on September 24, 2020 (the “Restated Second Amendment”).
+Added: Pursuant to the Restated Second Amendment, Amgen will have an option (the “Direct Purchase Option”) to subscribe for additional ordinary shares of the Company in the form of ADSs (the “Additional Shares”) in an amount necessary to enable it to increase (and subsequently maintain) its ownership at approximately 20.6 % of the Company's outstanding shares.
+Added: The Direct Purchase Option is exercisable on a monthly basis, but only if Amgen’s interest in the outstanding shares of the Company at the monthly reference date is less than 20.4 %.
+Added: The Direct Purchase Option (i) will be exercisable by Amgen solely as a result of dilution arising from issuance of new shares under the Company's equity incentive plans from time to time, and (ii) is subject to annual approval by the Company's independent shareholders each year during the term of the Restated Second Amendment.
+Added: The exercise period of the Direct Purchase Option commenced on December 1, 2020 and will terminate on the earliest of:
+Added: (a) the date on which Amgen and its affiliates collectively own less than 20% of the outstanding share capital of the Company as a result of Amgen’s sale of shares;
+Added: (b) at least 60-day advance written notice from either Amgen or the Company that such party wishes to terminate the Direct Purchase Option;
+Added: or (c) December 1, 2023.
+Added: The Direct Purchase Option has no vesting period
+Added: In July 2020, the Company issued 145,838,979 ordinary shares, par value $ 0.0001 , to eight existing investors, including entities associated with Hillhouse Capital and Baker Bros.
+Added: Advisors LP, as well as Amgen, in a registered direct offering under the Company's effective Registration Statement on Form S-3 (File No.
+Added: Each ordinary share was sold for a purchase price of $ 14.2308 per share ($ 185.00 per ADS), resulting in net proceeds, after offering expenses, of $ 2,069,610 .
+Added: Amgen purchased 29,614,832 ordinary shares for $ 421,443 as part of this offering.
+Added: The offering was made without an underwriter or a placement agent, and as a result the Company did not pay any underwriting discounts or commissions in connection with the offering.
Restricted Net Assets
The Company’s ability to pay dividends may depend on the Company receiving distributions of funds from its PRC subsidiaries.
−Removed: Relevant PRC statutory laws and regulations permit payments of dividends by the Company’s PRC subsidiaries only out of its retained earnings, if any, as determined in accordance with PRC accounting standards and regulations.
+Added: Relevant PRC laws and regulations permit payments of dividends by the Company’s PRC subsidiaries only out of its retained earnings, if any, as determined in accordance with PRC accounting standards and regulations.
The results of operations reflected in the consolidated financial statements prepared in accordance with GAAP differ from those reflected in the statutory financial statements of the Company’s PRC subsidiaries.
5 unchanged sentences
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.
−Removed: Foreign exchange and other regulation 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.
−Removed: As of December 31, 2019 and 2018 , amounts restricted are the net assets of the Company’s PRC subsidiaries, which amounted to $ 109,633 and $ 93,281 , respectively.
−Removed: Employee Defined Contribution Plans
+Added: 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.
+Added: As of December 31, 2020 and 2019, amounts restricted were the net assets of the Company’s PRC subsidiaries, which amounted to $ 119,776 and $ 109,633 , respectively.
+Added: Employee Benefit Plans
+Added: Defined Contribution Plans
Full-time employees of the Company in the PRC participate in a government mandated defined contribution plan, pursuant to which certain pension benefits, medical care, employee housing fund and other welfare benefits are provided to employees.
Chinese labor regulations require that the Company’s PRC subsidiaries make contributions to the government for these benefits based on certain percentages of the employees’ salaries.
−Removed: The Company has no legal obligation for the benefits beyond the contributions made.
+Added: The Company has no legal obligation for the benefits beyond the
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: contributions made.
The total amounts for such employee benefits, which were expensed as incurred, were $ 23,717 , $ 23,282 and $ 12,713 for the years ended December 31, 2020, 2019 and 2018, respectively.
−Removed: During the year ended December 31, 2016, the Company implemented a defined contribution 401(k) savings plan (the "401(k) Plan") for U.S.
+Added: The Company maintains a defined contribution 401(k) savings plan (the "401(k) Plan") for U.S.
The 401(k) Plan covers all U.S.
employees, and allows participants to defer a portion of their annual compensation on a pretax basis.
−Removed: In addition, the Company implemented a matching contribution to the 401(k) Plan, matching 50 % of an employee's contribution up to a maximum of 3 % of the participant's compensation.
+Added: In addition, the Company has a matching contribution to the 401(k) Plan, which, in the 2020 plan year, matched dollar for dollar of eligible contributions up to 4 %.
Company contributions to the 401(k) plan totaled $ 4,840 , $ 2,389 and $ 1,275 in the years ended December 31, 2020, 2019 and 2018, respectively.
−Removed: The Company maintains a government mandated program to cover employees of its wholly owned subsidiary in Switzerland for pension, death or disability.
−Removed: The pension arm of the program is considered a defined contribution plan.
+Added: The Company maintains a government mandated program to cover its employees in Switzerland for pension, death, or disability.
+Added: The program is considered a defined contribution plan.
Employer and employee contributions are made based on various percentages of salaries and wages that vary based on employee age and other factors.
−Removed: Company contributions into the program amounted to $ 528 , $ 55 , and nil in the years ended December 31, 2019 , 2018 and 2017 , respectively.
−Removed: Employee benefits for the remaining subsidiaries were immaterial.
+Added: Company contributions into the program amounted to $ 2,960 , $ 528 , and $ 55 in the years ended December 31, 2020, 2019 and 2018, respectively.
+Added: Employee benefit expenses for the remaining subsidiaries were immaterial.
+Added: Defined Benefit Plan
+Added: The Company also maintains a defined benefit pension plan covering its employees in Switzerland (the "Swiss Plan").
+Added: This plan is a government mandated fund that provides benefits to employees upon retirement, death, or disability.
+Added: Contributions are made based on various percentages of participants' salaries and wages determined based on participants' age and other factors.
+Added: As of December 31, 2020, the projected benefit obligation and plan assets under the Swiss Plan were approximately $ 23,566 and $ 15,453 , respectively.
+Added: The funded status of the Swiss Plan is included in other long-term liabilities in the accompanying consolidated balance sheets.
+Added: The initial determination of the pension liability was recorded as other comprehensive loss during the year ended December 31, 2020 (see Note 18).
+Added: The Company's annual contribution to the Swiss Plan is estimated to be approximately $ 1,357 in 2021 and is expected to evolve thereafter proportionally with changes in staffing and compensation levels, actuarial assumptions and actual investment returns on plan assets.
+Added: The following table reflects the total expected benefit payments to Swiss Plan participants and have been estimated based on the same assumptions used to measure the Company's benefit obligations as of December 31, 2020:
+Added: 2026 - 2030 1,919
Commitments and Contingencies
Purchase Commitments
−Removed: As of December 31, 2019 , the Company had purchase commitments amounting to $ 128,532 , of which $ 97,203 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $ 31,329 related to binding purchase order obligations of inventory from BMS.
−Removed: The Company does not have any minimum purchase requirements for inventory from BMS.
+Added: As of December 31, 2020, the Company had purchase commitments amounting to $ 123,383 , of which $ 101,236 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $ 22,147 related to binding purchase order obligations of inventory from BMS and Amgen.
+Added: The Company does not have any minimum purchase requirements for inventory from BMS or Amgen.
+Added: Capital commitments
+Added: The Company had capital commitments amounting to $ 44,972 for the acquisition of property, plant and equipment as of December 31, 2020, which were mainly for BeiGene Guangzhou Factory’s manufacturing facility, expansion of BGC's research
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: Capital commitments
−Removed: The Company had capital commitments amounting to $ 42,074 for the acquisition of property, plant and equipment as of December 31, 2019 , which were mainly for BeiGene Guangzhou Factory’s manufacturing facility and expansion of BGC's research and development activities in Guangzhou, China.
+Added: and development activities in Guangzhou, China, and research and development operations at the Changping facility in Beijing, China.
+Added: Co-development funding commitment
+Added: 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 .
+Added: The Company is funding its portion of the co-development costs by contributing cash and/or development services.
+Added: As of December 31, 2020, the Company's remaining co-development funding commitment was $ 1,019,009 .
Other Business Agreements
11 unchanged sentences
Quarter Ended
−Removed: September 30,
+Added: March 31, June 30, September 30, December 31,
+Added: Revenue 52,059 65,635 91,080 100,100
Loss from operations ( 373,756 ) ( 358,877 ) ( 440,137 ) ( 484,912 )
+Added: Net loss ( 364,939 ) ( 336,318 ) ( 426,617 ) ( 472,649 )
Net loss attributable to ordinary shareholders ( 363,735 ) ( 335,202 ) ( 425,224 ) ( 472,745 )
Basic and diluted net loss per share (1)
+Added: ( 0.36 ) ( 0.33 ) ( 0.37 ) ( 0.40 )
Quarter Ended
−Removed: September 30,
+Added: March 31, June 30, September 30, December 31,
+Added: Revenue 77,833 243,346 50,141 56,892
Loss from operations ( 173,755 ) ( 85,833 ) ( 312,266 ) ( 388,037 )
+Added: Net loss ( 168,069 ) ( 85,954 ) ( 308,660 ) ( 387,895 )
Net loss attributable to ordinary shareholders ( 167,640 ) ( 85,570 ) ( 307,357 ) ( 388,061 )
Basic and diluted net loss per share (1)
−Removed: (1) Per common share amounts for the quarters and full years have been calculated separately.
−Removed: Accordingly, the sum of quarterly amounts may not equal the annual amount because of differences in the weighted average common shares outstanding during each period, principally due to the effect of share issuances by the Company during the year.
+Added: ( 0.22 ) ( 0.11 ) ( 0.39 ) ( 0.49 )
+Added: (1) Per ordinary share amounts for the quarters and full years have been calculated separately.
+Added: Accordingly, the sum of quarterly amounts may not equal the annual amount because of differences in the weighted average ordinary shares outstanding during each period, principally due to the effect of share issuances by the Company during the year.
BEIGENE, LTD.
12 unchanged sentences
Year Ended December 31,
+Added: 2020 2019 2018
+Added: PRC 290,646 221,557 132,385
+Added: 18,228 134,689 42,793
+Added: Other — 71,966 23,042
+Added: Total 308,874 428,212 198,220
Subsequent Events
−Removed: On January 2, 2020, following approval by the Company's shareholders and satisfaction of other closing conditions, the Company announced the closing of its global strategic oncology collaboration with Amgen for the commercialization and development in China of Amgen’s XGEVA, KYPROLIS, and BLINCYTO, and the joint global development of 20 oncology assets in Amgen’s pipeline, with BeiGene responsible for development and commercialization in China.
−Removed: In connection with the collaboration, Amgen purchased a 20.5 % stake in BeiGene for approximately $ 2.8 billion in cash at $ 174.85 per ADS.
−Removed: On January 13, 2020, the Company entered into an exclusive development and commercialization agreement for the orphan biologic products SYLVANT ® (siltuximab) and QARZIBA ® (dinutuximab beta) in Greater China with EUSA Pharma ("EUSA").
−Removed: Under the terms of the agreement, EUSA granted the Company exclusive rights to SYLVANT in Greater China and to QARZIBA in mainland China.
−Removed: Under the agreement, the Company has agreed to fund and undertake all clinical development and regulatory submissions in the territories, and plans to launch and commercialize both products once approved.
−Removed: EUSA received a $ 40 million upfront payment and will be eligible to receive payments upon the achievement of regulatory and commercial milestones up to a total of $ 160 million .
−Removed: EUSA will also be eligible to receive tiered royalties on future product sales.
−Removed: Coronavirus Disease 2019 (COVID-19)
−Removed: Beginning in January 2020, the novel coronavirus (COVID-19) outbreak originating in Wuhan, China has impacted the Company’s operations in China, including commercial sales, regulatory interactions and inspections, and clinical trial recruitment and participation.
−Removed: Given the uncertainty of the situation, the duration of the business disruption and related financial impact cannot be reasonably estimated at this time.
+Added: On January 11, 2021, the Company entered into a collaboration and license agreement with Novartis Pharma AG (Novartis) to develop, manufacture and commercialize tislelizumab in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan.
+Added: The Company has agreed to jointly develop tislelizumab with Novartis in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals.
+Added: In addition, both companies may conduct clinical trials globally to explore combinations of tislelizumab with other cancer treatments, and the Company has an option to co-detail the product in North America, funded in part by Novartis.
+Added: Under the agreement the Company will receive an upfront cash payment of $ 650,000 from Novartis and is eligible to receive up to $ 1,300,000 upon the achievement of regulatory milestones, $ 250,000 upon the achievement of sales milestones, and royalties on future sales of tislelizumab in the licensed territory.
+Added: Closing of the transaction is subject to the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
+Added: On January 29, 2021, the Shanghai Stock Exchange (the "SSE") accepted a listing application submitted by the Company for a proposed public offering of the Company’s ordinary shares and listing of such shares on the Science and Technology Innovation Board (the “STAR Market”) of the SSE (the “STAR Offering”).
+Added: The STAR Offering will be conducted within the PRC, and such shares will be issued to and subscribed for by investors in Renminbi (“RMB”) in the PRC and listed and traded on the STAR Market in RMB (the “RMB Shares”).
+Added: The RMB Shares will not be fungible with the Company's ordinary shares listed on the Hong Kong Stock Exchange or with the Company's ADSs listed on the NASDAQ Global Select Market.
+Added: The number of RMB Shares (including the over-allotment option) to be issued will not exceed 132,313,549 ordinary shares, representing no more than 10% of the sum of the total number of issued ordinary shares of the Company as of January 7, 2021 and the total number of RMB Shares to be issued in the STAR Offering.
+Added: The consummation of the STAR Offering is subject to, among other things, market conditions, the approval of the shareholders of the Company, and applicable regulatory approvals.
Exhibit Index
−Removed: Exhibit Description
−Removed: Filed/ Furnished
−Removed: Incorporated by Reference
−Removed: Herein from Form or Schedule
+Added: Exhibit Description Filed/ Furnished
+Added: Herewith Incorporated by Reference
+Added: Herein from Form or Schedule Filing Date SEC File/
3.1 Fifth Amended and Restated Memorandum and Articles of Association of the Registrant, as currently in effect
21 unchanged sentences
(Exhibit 4.1) 11/17/2016 001-37686
+Added: .2 Amendment No.
+Added: 1 to Registration Rights Agreement, dated December 1, 2020, between the Company and the Investors
+Added: (Exhibit 10.1) 12/2/2020 001-37686
4.6 Description of BeiGene, Ltd.'s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934
Lease Agreements
−Removed: Lease dated February 1, 2011 by and between BeiGene (Beijing) Co., Ltd.
−Removed: and Beijing Xintaike Medical Device Co., Ltd.
−Removed: (English translation)
−Removed: (Exhibit 10.4)
10.1 Lease Agreement, dated as of April 10, 2016, between BeiGene (Suzhou) Co., Ltd.
2 unchanged sentences
(Exhibit 10.5) 5/12/2016 001-37686
−Removed: Exhibit Description
−Removed: Filed/ Furnished
−Removed: Incorporated by Reference
−Removed: Herein from Form or Schedule
+Added: Exhibit Description Filed/ Furnished
+Added: Herewith Incorporated by Reference
+Added: Herein from Form or Schedule Filing Date SEC File/
Collaboration, License and Commercial Agreements
−Removed: Amended Equity Joint Venture Contract regarding BeiGene Biologics Co., Ltd., dated April 11, 2017 between BeiGene (Hong Kong) Co., Limited and Guangzhou GET Technology Development Co., Ltd.
−Removed: (Exhibit 10.1)
−Removed: Amended Capital Increase Agreement with respect to BeiGene Biologics Co., Ltd., dated April 11, 2017, among BeiGene (Hong Kong) Co., Limited;
−Removed: Guangzhou GET Technology Development Co., Ltd.;
−Removed: and BeiGene Biologics Co., Ltd.
−Removed: (Exhibit 10.2)
−Removed: Shareholder Loan Contract with respect to BeiGene Biologics Co., Ltd, dated March 7, 2017, between Guangzhou GET Technology Development Co., Ltd.
−Removed: and BeiGene Biologics Co., Ltd.
−Removed: (Exhibit 10.3)
10.2# .1 License and Supply Agreement, dated July 5, 2017, by and between the Registrant and Celgene Logistics Sàrl
1 unchanged sentence
.2 Assignment and Assumption Agreement, dated December 29, 2017, by and between the Registrant and BeiGene Switzerland GmbH
+Added: (Exhibit 10.6.1)
+Added: 3/2/2020 001-37686
10.3 Share Subscription Agreement, dated July 5, 2017, by and between Celgene Switzerland LLC and the Registrant
(Exhibit 10.1) 7/6/2017 001-37686
−Removed: Exhibit Description
−Removed: Filed/ Furnished
−Removed: Incorporated by Reference
−Removed: Herein from Form or Schedule
10.4## Letter Agreement, dated June 14, 2019, by and among the Registrant, BeiGene Switzerland GmbH, Celgene Corporation and Celgene Switzerland LLC, to terminate the Amended and Restated Exclusive License and Collaboration Agreement, dated August 31, 2017
(Exhibit 10.1) 8/8/2019 001-37686
−Removed: Share Purchase Agreement, dated October 31, 2019, by and between Amgen Inc.
−Removed: and the Registrant
+Added: 10.5## .1 Share Purchase Agreement, dated October 31, 2019, by and between the Registrant and Amgen Inc.
+Added: (Exhibit 10.9) 3/2/2020 001-37686
.2 Amendment No.
−Removed: 1 to Share Purchase Agreement, dated December 6, 2019, by and between Amgen Inc.
−Removed: and the Registrant
+Added: 1 to Share Purchase Agreement, dated December 6, 2019, by and between the Registrant and Amgen Inc.
+Added: (Exhibit 10.10) 3/2/2020 001-37686
+Added: Exhibit Description Filed/ Furnished
+Added: Herewith Incorporated by Reference
+Added: Herein from Form or Schedule Filing Date SEC File/
+Added: .3 Restated Amendment No.
+Added: 2 to Share Purchase Agreement, dated September 24, 2020, by and between the Registrant and Amgen Inc.
+Added: (Exhibit 10.1) 9/24/2020 001-37686
10.6## Collaboration Agreement, dated October 31, 2019, by and among the Registrant, BeiGene Switzerland GmbH and Amgen Inc.
−Removed: Guarantee, dated October 31, 2019, made by and between Amgen Inc.
−Removed: and the Registrant
+Added: (Exhibit 10.11) 3/2/2020 001-37686
+Added: 10.7 Guarantee, dated October 31, 2019, by and between the Registrant and Amgen Inc.
+Added: (Exhibit 10.12) 3/2/2020 001-37686
+Added: 10.8 Form of Share Purchase Agreement dated July 12, 2020 by and among the Registrant and Purchasers named therein
+Added: (Exhibit 10.1) 7/13/2020 001-37686
Equity and Other Compensation Plans
3 unchanged sentences
(Exhibit 10.1) 12/12/2018 001-37686
+Added: .2† Amendment No.
+Added: 1 to the Second Amended and Restated 2016 Share Option and Equity Plan
+Added: (Exhibit 10.1) 6/17/2020 001-37686
.3† Forms of Restricted Share Unit Award Agreement for Non-Employee Directors under the 2016 Share Option and Incentive Plan
14 unchanged sentences
(Exhibit 10.3) 6/8/2018 001-37686
−Removed: Exhibit Description
−Removed: Filed/ Furnished
−Removed: Incorporated by Reference
−Removed: Herein from Form or Schedule
.3† Form of Restricted Share Unit Award Agreement under the 2018 Inducement Equity Plan
2 unchanged sentences
(Exhibit 10.2) 12/12/2018 001-37686
+Added: Exhibit Description Filed/ Furnished
+Added: Herewith Incorporated by Reference
+Added: Herein from Form or Schedule Filing Date SEC File/
.2† Amendment No.
13 unchanged sentences
(Exhibit 10.1) 8/9/2018 001-37686
+Added: .2† Employment Apportionment Agreement, dated March 1, 2020, by and between BeiGene (Beijing) Co., Ltd., BeiGene Guangzhou Biologics Manufacturing Co., Ltd.
+Added: and Xiaobin Wu
+Added: (Exhibit 10.2) 5/11/2020 001-37686
10.18† Employment Agreement, dated July 13, 2015, by and between BeiGene USA, Inc.
4 unchanged sentences
(Exhibit 10.2) 11/10/2016 001-37686
−Removed: Consulting Agreement, dated July 24, 2018, by and between the Registrant and Xiaodong Wang
−Removed: (Exhibit 10.8)
−Removed: Exhibit Description
−Removed: Filed/ Furnished
−Removed: Incorporated by Reference
−Removed: Herein from Form or Schedule
+Added: 10.20† Consulting Agreement, dated February 24, 2021, by and between the Registrant and Xiaodong Wang
+Added: Exhibit Description Filed/ Furnished
+Added: Herewith Incorporated by Reference
+Added: Herein from Form or Schedule Filing Date SEC File/
21.1 List of Subsidiaries of the Registrant
1 unchanged sentence
31.1 Certification of Principal Executive Officer pursuant to Rule 13a‑14(a) and Rule 15d‑14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes‑Oxley Act of 2002
−Removed: Certification of Principle Financial Officer pursuant to Rule 13a‑14(a) and Rule 15d‑14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes‑Oxley Act of 2002
+Added: 31.2 Certification of Princ i p a l Financial Officer pursuant to Rule 13a‑14(a) and Rule 15d‑14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes‑Oxley Act of 2002
32.1* Certification of Principal Executive Officer and Principle Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes‑Oxley Act of 2002
−Removed: Inline XBRL Instance Document - the instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document
−Removed: Inline XBRL Taxonomy Extension Schema Document
−Removed: Inline XBRL Taxonomy Extension Calculation Linkbase Document
−Removed: Inline XBRL Taxonomy Extension Label Linkbase Document
−Removed: Inline XBRL Taxonomy Extension Presentation Linkbase Document
−Removed: Inline XBRL Taxonomy Extension Definition Linkbase Document
−Removed: Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.*)
+Added: 101.INS Inline XBRL Instance Document - the instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document
+Added: 101.SCH Inline XBRL Taxonomy Extension Schema Document X
+Added: 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document X
+Added: 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document X
+Added: 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document X
+Added: 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document X
+Added: 104 Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.*) X
† Indicates a management contract or any compensatory plan, contract or arrangement.
7 unchanged sentences
BEIGENE, LTD.
−Removed: March 2, 2020
+Added: February 25, 2021 By:
Chief Executive Officer and Chairman
5 unchanged sentences
Pursuant to the requirements of the Securities Exchange Act of 1934, this Annual Report on Form 10‑K has been signed by the following persons in the capacities indicated below and on the dates indicated:
−Removed: Chief Executive Officer and Chairman
−Removed: March 2, 2020
−Removed: (Principal Executive Officer)
−Removed: /s/ HOWARD LIANG
−Removed: Chief Financial Officer and Chief Strategy Officer
−Removed: March 2, 2020
−Removed: (Principal Financial and Accounting Officer)
−Removed: /s/ TIMOTHY CHEN
−Removed: March 2, 2020
+Added: Signature Title Date
+Added: OYLER Chief Executive Officer and Chairman February 25, 2021
+Added: Oyler (Principal Executive Officer)
+Added: /s/ HOWARD LIANG Chief Financial Officer and Chief Strategy Officer February 25, 2021
+Added: Howard Liang (Principal Financial and Accounting Officer)
+Added: /s/ TIMOTHY CHEN Director February 25, 2021
/s/ DONALD W.
−Removed: March 2, 2020
−Removed: /s/ MICHAEL GOLLER
−Removed: March 2, 2020
+Added: GLAZER Director February 25, 2021
+Added: /s/ MICHAEL GOLLER Director February 25, 2021
Michael Goller
/s/ ANTHONY C.
−Removed: March 2, 2020
−Removed: /s/ RANJEEV KRISHANA
−Removed: March 2, 2020
+Added: HOOPER Director February 25, 2021
+Added: /s/ RANJEEV KRISHANA Director February 25, 2021
Ranjeev Krishana
−Removed: /s/ THOMAS MALLEY
−Removed: March 2, 2020
+Added: /s/ THOMAS MALLEY Director February 25, 2021
Thomas Malley
−Removed: /s/ XIAODONG WANG
−Removed: March 2, 2020
+Added: /s/ XIAODONG WANG Director February 25, 2021
Xiaodong Wang
−Removed: /s/ JING-SHYH (SAM) SU
−Removed: March 2, 2020
+Added: /s/ CORAZON (CORSEE) D.
+Added: SANDERS Director February 25, 2021
+Added: Corazon (Corsee) D.
+Added: /s/ JING-SHYH (SAM) SU Director February 25, 2021
Jing-Shyh (Sam) Su
−Removed: /s/ QINGQING YI
−Removed: March 2, 2020
+Added: /s/ QINGQING YI Director February 25, 2021
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.