3 unchanged sentences
Securities and Exchange Commission rules and forms.
−Removed: Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
+Added: Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file
+Added: or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
In designing and evaluating the disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurances of achieving the desired control objectives, and management necessarily was required to apply its judgment in designing and evaluating the controls and procedures.
11 unchanged sentences
Other Information
−Removed: Consulting Agreement
−Removed: On February 24, 2021, the Company entered into a consulting agreement (the “2021 Consulting Agreement”) with Dr.
−Removed: Xiaodong Wang, co-founder, director and Chairman of the Scientific Advisory Board, to renew the consulting arrangement between the Company and Dr.
−Removed: Wang on substantially the same terms and conditions as his existing consulting agreement, which expired on December 31, 2020.
−Removed: Pursuant to the 2021 Consulting Agreement, Dr.
−Removed: 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.
−Removed: The 2021 Consulting Agreement is effective from January 1, 2021 and will expire on December 31, 2023.
−Removed: The Company may terminate the 2021 Consulting Agreement upon 30 days’ prior notice to Dr.
−Removed: Wang, provided that Dr.
−Removed: Wang will be entitled to payment for services performed prior to such date.
−Removed: 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.
+Added: Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
+Added: Not applicable.
Directors, Executive Officers and Corporate Governance
11 unchanged sentences
Principal Accounting Fees and Services
+Added: Our independent public accounting firm is Ernst & Young Hua Ming LLP (PCAOB ID:
+Added: 1408 ), located in Beijing, People's Republic of China.
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the U.S.
24 unchanged sentences
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, 2021, 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 28, 2022 expressed an unqualified opinion thereon.
−Removed: Adoption of New Accounting Standard
−Removed: 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
28 unchanged sentences
We also assessed the accrual methodology used by the Company, including the adequacy of related disclosures in the consolidated financial statements.
−Removed: Allocation of proceeds received in relation to the Amgen Collaboration and Share Purchase Agreements
−Removed: 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.
−Removed: (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.
−Removed: 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.
−Removed: The Company allocated the cash proceeds between the equity issued and the R&D cost share liability based on a relative fair value method.
−Removed: 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.
−Removed: 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.
−Removed: 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: Allocation of transaction price in relation to the Novartis Tislelizumab Agreement
+Added: Description of the Matter As described in Notes 2 and 3 to the Company's consolidated financial statements, the Company entered into a collaboration and license agreement for tislelizumab with Novartis Pharma AG (“the Novartis Tislelizumab Agreement”), which resulted in the recognition of $538.1 million of revenue for the year ended December 31, 2021 and $111.9 million of deferred revenue as of December 31, 2021.
+Added: The Company evaluated the Novartis Tislelizumab Agreement under ASC 606, Revenue from Contracts with Customers (“ASC 606”) and identified two performance obligations within the arrangement:
+Added: 1) exclusive license for Novartis to develop, manufacture, and commercialize tislelizumab in the Novartis Territory, transfer of know-how and use of the tislelizumab trademark (“PD-1 License obligation”);
+Added: and 2) conducting and completing ongoing trials of tislelizumab (“R&D services obligation”).
+Added: The transaction price of $650.0 million was allocated to each performance obligation based on their relative standalone selling prices.
+Added: The standalone selling price of the PD-1 License obligation is determined using the adjusted market assessment approach based on the probability-weighted present value of forecasted cash flows associated with out-licensing tislelizumab in the Novartis Territory.
+Added: The standalone selling price of R&D services obligation is determined using an expected cost plus a margin approach based on the present value of estimated tislelizumab clinical trial costs plus a reasonable margin.
+Added: The transaction price allocated to the PD-1 License obligation was recognized at a point in time when the license was delivered and the transfer of know-how was completed.
+Added: The transaction price allocated to the R&D services obligation was deferred and recognized over time using a percentage-of-completion method.
+Added: Auditing the Company’s allocation of the transaction price in relation to the Novartis Tislelizumab Agreement is complex due to the significant estimates and judgments involved in determining the standalone selling prices for each performance obligation identified.
+Added: The estimates of the standalone selling prices involved management’s key assumptions such as revenue growth rate, estimated clinical trial costs, mark-up rate, probability of technical and regulatory success, and discount rates.
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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: We compared these significant assumptions to current market trends, industry data, and current clinical stages of the pipeline assets.
−Removed: 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.
−Removed: In addition, we assessed the related disclosures in the consolidated financial statements.
+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 the transaction price in relation to the Novartis Tislelizumab Agreement.
+Added: For example, we tested controls over management's review of the valuation methodologies and significant assumptions used in determining the estimated standalone selling prices of the identified performance obligations.
+Added: To test the allocation of the transaction price in relation to the Novartis Tislelizumab Agreement, our audit procedures included, among others, evaluating the valuation methodologies and the discount rates used by management to determine the standalone selling prices of the identified performance obligations, with the assistance of our internal valuation specialists.
+Added: We tested the significant assumptions and the completeness and accuracy of the underlying data used by the Company in developing its projected future cashflows, including the revenue growth rate, the estimated clinical trial costs, mark-up rate and the probability of technical and regulatory success.
+Added: We compared these significant assumptions to industry, business and market data and information available from third-party sources.
+Added: We evaluated the sensitivity of the mark-up rate, probability of technical and regulatory success, and discount rates by assessing the changes to revenue recognition amounts from changes in these assumptions, both individually and in the aggregate.
+Added: In addition, we assessed the adequacy of the related disclosures in the consolidated financial statements.
/s/ Ernst & Young Hua Ming LLP
54 unchanged sentences
Accrued expenses and other payables 12 558,055 346,144
+Added: Deferred revenue, current portion 3 187,414 —
Tax payable 11 21,395 20,380
4 unchanged sentences
Non-current liabilities:
−Removed: Long-term bank loans 14 183,637 83,311
−Removed: Shareholder loan 14 — 157,384
+Added: Long-term debt 13 202,113 183,637
+Added: Deferred revenue, non-current portion 3 220,289 —
Operating lease liabilities, non-current portion 8 43,041 29,417
9 unchanged sentences
Additional paid-in capital 11,191,007 7,414,932
−Removed: Accumulated other comprehensive income (loss) 18 6,942 ( 8,001 )
+Added: Accumulated other comprehensive income 17 17,950 6,942
Accumulated deficit ( 4,966,103 ) ( 3,552,749 )
−Removed: Total BeiGene, Ltd.
−Removed: shareholders’ equity 3,869,243 962,205
−Removed: Noncontrolling interest 8 — 16,150
Total equity 6,242,987 3,869,243
16 unchanged sentences
Loss from operations ( 1,438,735 ) ( 1,657,682 ) ( 959,891 )
−Removed: Interest income, net 1,998 9,131 13,947
+Added: Interest (expense) income, net ( 15,757 ) 1,998 9,131
Other income, net 5 15,904 37,490 7,174
20 unchanged sentences
Pension liability adjustments 20 1,865 ( 8,113 ) —
−Removed: Unrealized holding (loss) gain, net 18 ( 419 ) ( 448 ) 2,133
+Added: Unrealized holding loss, net 17 ( 4,571 ) ( 419 ) ( 448 )
Comprehensive loss ( 1,402,346 ) ( 1,585,452 ) ( 960,450 )
17 unchanged sentences
Unrealized gains on equity investments 5 ( 7,632 ) ( 11,826 ) —
−Removed: Gain on deconsolidation of a subsidiary 6 ( 11,307 ) — —
Deferred income tax benefits ( 41,085 ) ( 27,807 ) ( 9,232 )
3 unchanged sentences
Inventories ( 153,333 ) ( 58,906 ) ( 12,311 )
−Removed: Prepaid expenses and other current assets ( 65,528 ) 45 ( 38,607 )
−Removed: Other non-current assets 9,311 ( 20,782 ) ( 40,228 )
+Added: Other assets ( 107,128 ) ( 56,217 ) ( 20,737 )
Accounts payable 20,008 95,835 2,224
Accrued expenses and other payables 140,044 185,012 71,596
−Removed: Tax payable 2,319 7,566 ( 3,355 )
Deferred revenue 407,703 — ( 27,982 )
−Removed: Operating lease liabilities ( 102 ) ( 2,283 ) —
−Removed: Other long-term liabilities ( 25,401 ) 8,482 16,962
+Added: Other liabilities ( 2,620 ) ( 25,503 ) 6,199
Net cash used in operating activities ( 1,298,723 ) ( 1,283,461 ) ( 750,269 )
1 unchanged sentence
Purchases of property and equipment ( 262,942 ) ( 117,508 ) ( 89,612 )
−Removed: Deconsolidation of a subsidiary ( 2,025 ) — —
−Removed: Purchase of intangible assets — — ( 553 )
−Removed: Payment for asset acquisition, net of cash acquired 4 — — ( 38,298 )
−Removed: Purchases of investments ( 5,690,408 ) ( 1,169,300 ) ( 2,635,686 )
−Removed: Proceeds from sale or maturity of investments 2,751,075 1,882,075 2,177,207
+Added: Purchases of short-term investments ( 2,147,881 ) ( 5,663,727 ) ( 1,169,300 )
+Added: Proceeds from sale or maturity of short-term investments 3,146,891 2,751,075 1,882,075
Purchase of in-process research and development ( 8,500 ) ( 109,500 ) ( 69,000 )
−Removed: Net cash (used in) provided by investing activities ( 3,168,366 ) 554,163 ( 637,613 )
+Added: Purchase of intangible assets 10 ( 43,409 ) — —
+Added: Purchase of long-term investments 5 ( 43,500 ) ( 26,681 ) —
+Added: Other investing activities — ( 2,025 ) —
+Added: Net cash provided by (used in) investing activities 640,659 ( 3,168,366 ) 554,163
Cash flows from financing activities:
−Removed: Proceeds from public offering, net 19 — — 757,587
−Removed: Proceeds from public offering and HK IPO, net 19 — — 869,709
+Added: Proceeds from public offering, net of cost 18 3,392,616 — —
Proceeds from sale of ordinary shares, net of cost 18 50,000 4,232,017 —
1 unchanged sentence
Payment to acquire joint venture (JV) minority interest 7 — ( 28,723 ) —
−Removed: Proceeds from loans 14 433,905 67,489 42,315
−Removed: Repayment of loans 14 ( 144,308 ) ( 32,813 ) ( 8,736 )
+Added: Proceeds from long-term loan 13 16,838 110,208 67,489
+Added: Repayment of long-term loan 13 — ( 132,061 ) ( 32,813 )
+Added: Proceeds from short-term loans 13 406,449 323,697 —
+Added: Repayment of short-term loans 13 ( 321,754 ) ( 12,247 ) —
Capital contribution from noncontrolling interest — — 4,000
5 unchanged sentences
Cash, cash equivalents, and restricted cash, end of year 4,382,887 1,390,005 620,775
−Removed: Year Ended December 31,
−Removed: Note 2020 2019 2018
Supplemental cash flow disclosures:
7 unchanged sentences
Purchase of in-process research and development included in accounts payable 75,000 — —
−Removed: Changes in operating assets and liabilities adjusted through accumulated deficit — — 2,291
−Removed: The accompanying notes are an integral part of these consolidated financial statem ent s.
+Added: The accompanying notes are an integral part of these consolidated financial statements.
BEIGENE, LTD.
11 unchanged sentences
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
−Removed: Adjustment to opening balance of equity — — — 263 ( 2,929 ) ( 2,666 ) 375 ( 2,291 )
−Removed: Balance at January 1, 2018 592,072,330 59 1,000,747 ( 217 ) ( 333,446 ) 667,143 14,797 681,940
−Removed: 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 HK IPO 65,600,000 7 869,702 — — 869,709 — 869,709
−Removed: Issuance of shares reserved for share option exercises 1,299,186 — — — — — — —
−Removed: Share-based compensation — — 87,127 — — 87,127 — 87,127
−Removed: Exercise of options and release of RSUs 14,321,268 1 29,661 — — 29,662 — 29,662
−Removed: Other comprehensive income/(loss) — — — 1,743 — 1,743 ( 88 ) 1,655
−Removed: Net loss — — — — ( 673,769 ) ( 673,769 ) ( 264 ) ( 674,033 )
−Removed: 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
Contributions from shareholders — — — — — — 4,000 4,000
15 unchanged sentences
Balance at December 31, 2020 1,190,821,941 118 7,414,932 6,942 ( 3,552,749 ) 3,869,243 — 3,869,243
+Added: Issuance of ordinary shares in connection with STAR Offering 115,055,260 12 3,392,604 — — 3,392,616 — 3,392,616
+Added: Proceeds from issuance of ordinary shares, net of cost 2,151,877 — 50,000 — — 50,000 — 50,000
+Added: Exercise of options, ESPP and release of RSUs 28,778,893 3 92,759 — — 92,762 — 92,762
+Added: Use of shares reserved for share option exercises ( 2,003,690 ) — — — — — — —
+Added: Share-based compensation — — 240,712 — — 240,712 — 240,712
+Added: Other comprehensive income — — — 11,008 — 11,008 11,008
+Added: Net loss — — — — ( 1,413,354 ) ( 1,413,354 ) — ( 1,413,354 )
+Added: Balance at December 31, 2021 1,334,804,281 133 11,191,007 17,950 ( 4,966,103 ) 6,242,987 — 6,242,987
The accompanying notes are an integral part of these consolidated financial statements.
7 unchanged sentences
(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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: The Company currently has three approved medicines that were discovered and developed in its own labs, including BRUKINSA ® , a small molecule inhibitor of Bruton’s Tyrosine Kinase (BTK) for the treatment of various blood cancers, tislelizumab, an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers, and pamiparib, a selective small molecule inhibitor of PARP1 and PARP2.
+Added: The Company has obtained approvals to market BRUKINSA ® in the United States, the People's Republic of China (China or the PRC), the European Union (EU), the United Kingdom (U.K.), Canada, Australia and additional international markets, and tislelizumab and pamiparib in China.
+Added: By leveraging its China commercial capabilities, the Company has in-licensed the rights to distribute 13 approved medicines for the China market.
+Added: Supported by its global clinical development and commercial capabilities, the Company has entered into collaborations with world-leading biopharmaceutical companies such as Amgen and Novartis Pharma AG (Novartis) to develop and commercialize innovative medicines.
+Added: The Company is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe.
+Added: Its internal clinical development capabilities are deep, including a more than 2,200 -person global clinical development team that is running more than 90 ongoing or planned clinical trials in over 30 medicines and drug candidates.
+Added: This includes more than 30 pivotal or potentially registration-enabling trials across its portfolio, including its three internally discovered, approved medicines.
+Added: The Company has enrolled in its clinical trials more than 14,500 subjects, of which approximately one-half have been outside of China.
+Added: The Company has built, and is expanding, its internal manufacturing capabilities, through its state-of-the-art biologic and small molecule manufacturing facilities in China to support current and potential future demand of its medicines, and plans to build a commercial-stage biologics manufacturing and clinical R&D center in New Jersey.
+Added: The Company also works with high quality contract manufacturing organizations (CMOs) to manufacture its internally developed clinical and commercial products.
+Added: Since its inception in 2010, the Company has become a fully integrated global organization of over 8,000 employees in 23 countries and regions, including the United States, China, Europe, and Australia.
Summary of Significant Accounting Policies
12 unchanged sentences
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, valuation and recognition of share-based compensation expenses, realizability of deferred tax assets, estimating uncertain tax positions, valuation of inventory,
+Added: Areas where management uses subjective judgment include, but are not limited to, estimating the useful lives of long-lived assets, estimating
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: 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.
+Added: 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, assessing the impairment of long-lived assets, valuation and recognition of share-based compensation expenses, realizability of deferred tax assets, estimating uncertain tax positions, valuation of inventory, estimating the allowance for credit losses, determining defined benefit pension plan obligations, measurement of right-of-use assets and lease liabilities and the fair value of financial instruments.
Management bases the estimates on historical experience, known trends and various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities.
30 unchanged sentences
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: 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.
−Removed: 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
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+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.
+Added: 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.
+Added: The determination of whether inventory costs will be realizable requires estimates by management.
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.
23 unchanged sentences
No impairment losses or allowance for credit losses on investments were recorded for any periods presented.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Property, Plant and Equipment
Property, plant and equipment are stated at cost, less accumulated depreciation and amortization.
−Removed: Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets as follows:
+Added: Property, plant and equipment, other than land and construction in progress, are depreciated using the straight-line method over the estimated useful lives of the respective assets as follows:
Building 20 years
3 unchanged sentences
Leasehold Improvements Lesser of useful life or lease term
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Effective January 1, 2019, the Company adopted ASC, Topic 842, Leases (ASC 842) using the effective date method.
23 unchanged sentences
The ROU asset is amortized over the remaining lease term.
−Removed: In 2017, the Company acquired a land use right from the local Bureau of Land and Resources in Guangzhou for the purpose of constructing and operating the biologics manufacturing facility in Guangzhou.
−Removed: In 2019, the Company acquired a second Guangzhou land use right from the local Bureau of Land and Resources in Guangzhou.
−Removed: Both Guangzhou land use rights are being amortized over the respective terms of the land use rights, which are each 50 years.
−Removed: In 2018, the Company acquired a land use right in conjunction with the Innerway asset acquisition (see Note 4).
−Removed: The land use right is being amortized over the term of the land use right, which is 36 years.
−Removed: 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.
−Removed: The land use right is being amortized over the term of the land use right, which is 30 years.
−Removed: Business Combinations
−Removed: The Company accounts for its business combinations using the acquisition method of accounting in accordance with ASC topic 805 (“ASC 805”):
−Removed: Business Combinations .
−Removed: The acquisition method of accounting requires all of the following steps:
−Removed: (i) identifying the acquirer, (ii) determining the acquisition date, (iii) recognizing and measuring the identifiable assets acquired, the liabilities assumed, and any noncontrolling interest in the acquiree, and (iv) recognizing and measuring goodwill or a gain from a bargain purchase.
−Removed: 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: In 2017, the Company acquired a land use right from the local Bureau of Land and Resources in Guangzhou for the purpose of constructing and operating the Company's biologics manufacturing facility in Guangzhou.
+Added: In 2019, the Company acquired a second Guangzhou land use right from the local Bureau of Land and Resources.
+Added: In 2021, the Company acquired two land use rights from the local Bureau of Land and Resources to expand its biologics manufacturing facility in Guangzhou.
+Added: Guangzhou land use rights are being amortized over the respective terms of the land use rights, which are each 50 years.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: The costs directly attributable to the acquisition are expensed as incurred.
−Removed: Identifiable assets, liabilities and contingent liabilities acquired or assumed are measured separately at their fair value as of the acquisition date, irrespective of the extent of any noncontrolling interests.
−Removed: The excess of (i) acquisition consideration, fair value of the noncontrolling interests and acquisition date fair value of any previously held equity interest in the acquiree over (ii) the fair value of the identifiable net assets of the acquiree, is recorded as goodwill.
−Removed: If the cost of acquisition is less than the fair value of the net assets of the subsidiary acquired, the difference is recognized directly in the consolidated statements of operations as a gain.
−Removed: The Company allocates the fair value of purchase consideration to the tangible assets acquired, liabilities assumed and intangible assets acquired based on their estimated fair values.
−Removed: The excess of the fair value of purchase consideration over the fair values of these identifiable assets and liabilities is recorded as goodwill.
−Removed: Such valuations require management to make significant estimates and assumptions, especially with respect to intangible assets.
−Removed: Significant estimates in valuing certain intangible assets may include, but are not limited to, future expected cash flows from acquired assets, timing and probability of success of clinical events and regulatory approvals, and assumptions on useful lives and discount rates.
−Removed: Management's estimates of fair value are based upon assumptions believed to be reasonable, but which are inherently uncertain and unpredictable and, as a result, actual results may differ from estimates.
−Removed: Additional information, such as that related to income tax and other contingencies, existing as of the acquisition date but unknown to us may become known during the remainder of the measurement period, not to exceed one year from the acquisition date, which may result in changes to the amounts and allocations recorded.
−Removed: Acquisitions that do not meet the accounting definition of a business combination are accounted for as asset acquisitions.
−Removed: For transactions determined to be asset acquisitions, the Company allocates the total cost of the acquisition, including transaction costs, to the net assets acquired based on their relative fair values.
+Added: In 2018, the Company acquired a land use right in conjunction with the acquisition of Beijing Innerway Bio-tech Co., Ltd.
+Added: 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 construct 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.
Goodwill and Other Intangible Assets
10 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, 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).
−Removed: The Company amortized the trading license over the remainder of the initial license term through February 2020.
+Added: Intangible assets associated with milestone payments made to third parties subsequent to regulatory approval are recorded at cost.
+Added: Identifiable intangible assets consist of distribution rights for approved cancer therapies licensed from BMS that are amortized on a straight-line basis over the estimated useful lives of the assets, which is 10 years;
+Added: post-approval milestone payments under license and commercialization agreements, that are amortized over the remainder of the product patent or the term of the commercialization agreements;
+Added: and trading licenses that are amortized over the initial license term.
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
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: 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 generated by the assets, when the market prices are not readily available.
For the years ended December 31, 2021, 2020 and 2019, the Company determined that there were no indicators of impairment of its other intangible assets.
4 unchanged sentences
For the years ended December 31, 2021, 2020 and 2019, there was no impairment of the value of the Company’s long-lived assets.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Fair Value Measurements
8 unchanged sentences
(1) market approach;
−Removed: (2) income approach and (3) cost approach.
+Added: (2) income approach;
+Added: and (3) cost approach.
The market approach uses prices and other relevant information generated from market transactions involving identical or comparable assets or liabilities.
29 unchanged sentences
treasury securities 3,268,725 — —
+Added: Other non-current assets (Note 5):
+Added: Equity securities 10,810 6,669 —
Total 3,646,445 6,669 —
3 unchanged sentences
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.
−Removed: ("Leap"), which were acquired in connection with a collaboration and license agreement entered into in January 2020.
+Added: (Leap), which were acquired in connection with a collaboration and license agreement entered into in January 2020 and in Leap's underwritten public offering in September 2021.
The common stock investment in Leap, a publicly-traded biotechnology company, is measured and carried at fair value and classified as Level 1.
2 unchanged sentences
As of December 31, 2021 and 2020, 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.
−Removed: 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.
+Added: Long-term debt approximates its 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
10 unchanged sentences
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 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.
−Removed: 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.
−Removed: Amounts due to Amgen
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: for its portion of net product sales are recorded as cost of sales.
+Added: Product Revenue
+Added: The Company generates product revenues in China through the sale of its internally developed drugs tislelizumab, BRUKINSA ® and pamiparib, and the sale of in-licensed products through its agreements with Amgen, BMS, Bio-Thera and EUSA Pharma.
+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 for its portion of net product sales are recorded as cost of sales.
In the United States, the Company generates product revenues from the sale of BRUKINSA ® .
−Removed: 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 China, the Company sells its internally developed products to multiple distributors, who in turn sell the product to hospitals or pharmacies within their authorized territories to be sold ultimately to patients.
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.
9 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 are offered to distributors.
−Removed: The Company records a provision for rebates at the time of sale based on contracted rates and historical redemption rates.
−Removed: Assumptions used to establish the provision include the level of distributor inventories, sales volumes and contract pricing and estimated acceptance of government pricing or reimbursement amounts (such as provincial acceptance of the National Reimbursement Drug List pricing in the PRC).
−Removed: The Company regularly reviews the information related to these estimates and adjusts the provision accordingly.
−Removed: In the United States, estimates for variable consideration for which reserves are established at the time of sale include government rebates, chargebacks, trade discounts and allowances, sales returns allowances and other incentives that are offered within contracts between the Company and its US customers, health care providers and other indirect customers.
−Removed: 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.
+Added: Estimates for variable consideration for which reserves are established at the time of sale include government and commercial rebates, provisions for acceptance of National Reimbursement Drug List pricing in the PRC, chargebacks, trade discounts and allowances, sales returns allowances and other incentives that are offered within contracts between the Company and its customers, health care providers and other indirect customers.
+Added: 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, channel inventory levels, specific known market events and trends, industry data and forecasted customer buying and payment patterns.
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.
7 unchanged sentences
For elements of 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.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+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.
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.
7 unchanged sentences
For licenses determined to be distinct, the Company recognizes revenues from non-refundable up-front fees allocated to the license at a point in time, when the license is transferred to the licensee and the licensee is able to use and benefit from the license.
+Added: Options to License Intellectual Property:
+Added: Upfront non-refundable payments for options to license the Company’s intellectual property are evaluated to determine if the option represents a material right and is distinct from the other performance obligations identified in the arrangement.
+Added: For options determined to be a material right and distinct, the Company defers the non-refundable up-front fees allocated to the option and recognizes revenues at a point in time, at the earlier of when the option is exercised or the option period expires.
+Added: Right to Access Intellectual Property during the Option Period:
+Added: The portion of a transaction price allocated to the other parties right to access the Company's intellectual property to generate their own data during an option period is deferred and recognized as collaboration revenue over the option period on a straight-line basis as the right to use the intellectual property is provided and the data generated.
Research and Development Services:
−Removed: The portion of the transaction price allocated to research and development services performance obligations is deferred and recognized as collaboration revenue over time as delivery or performance of such services occurs.
−Removed: R&D reimbursement revenue for revenue attributable to the clinical trials that BMS had opted into is recognized as delivery or performance of such services occurs.
+Added: The portion of a transaction price allocated to research and development services performance obligations is deferred and recognized as collaboration revenue over time as delivery or performance of such services occurs.
Milestone Payments:
8 unchanged sentences
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Research and Development Expenses
−Removed: Research and development expenses represent costs associated with the collaborative arrangements, which primarily include (i) payroll and related costs (including share-based compensation) associated with research and development personnel, (ii) costs related to clinical trials and preclinical testing of the Company’s technologies under development, (iii) costs to develop the product candidates, including raw materials and supplies, product testing, depreciation, and facility related expenses, (iv) expenses for research services provided by universities and contract laboratories, including sponsored research funding, and (v) other research and development expenses.
+Added: Research and development expenses consist of the costs associated with our research and development activities, conducting preclinical studies and clinical trials, and activities related to regulatory filings, which primarily include (i) payroll and related costs (including share-based compensation) associated with research and development personnel, (ii) costs related to clinical trials and preclinical testing of the Company’s technologies under development, (iii) costs to develop the product candidates, including raw materials and supplies, product testing, depreciation, and facility related expenses, (iv) expenses for research services provided by universities and contract laboratories, including sponsored research funding, and (v) other research and development expenses.
Research and development expenses are charged to expense as incurred when these expenditures relate to the Company’s research and development services and have no alternative future uses.
4 unchanged sentences
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.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
The process of estimating the Company's research and development expenses involves reviewing open contracts and purchase orders, communicating with its personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated costs incurred for the services when the Company has not yet been invoiced or otherwise notified of the actual costs.
15 unchanged sentences
Among other disclosures, ASC 220, Comprehensive Income , requires that all items that are required to be recognized under current accounting standards as components of comprehensive loss be reported in a financial statement that is displayed with the same prominence as other financial statements.
−Removed: For each of the periods presented, the Company’s comprehensive loss includes net loss, foreign currency translation adjustments, pension liability adjustments and unrealized holding gains/losses associated with the available-for-sale debt securities, and is presented in the consolidated statements of comprehensive loss.
+Added: For each of the periods presented, the Company’s comprehensive loss includes net
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: 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: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Forfeiture rates are estimated based on historical and future expectations of employee turnover rates and are adjusted to reflect future changes in circumstances and facts, if any.
17 unchanged sentences
A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The Company evaluates its uncertain tax positions using the provisions of ASC 740, Income Taxes, which prescribes a recognition threshold that a tax position is required to meet before being recognized in the financial statements.
9 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: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
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.
−Removed: 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.
+Added: Ordinary equivalent shares consist of the ordinary shares issuable upon the conversion of the Company’s convertible preferred shares, if any, 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.
Ordinary share equivalents are excluded from the computation of diluted loss per share if their effects would be anti-dilutive.
5 unchanged sentences
Concentration of credit risk
−Removed: Financial instruments that are potentially subject to credit risk consist of cash and cash equivalents and short-term investments.
−Removed: The carrying amounts of cash and cash equivalents and short-term investments represent the maximum amount of loss due to credit risk.
−Removed: As of December 31, 2020 and 2019, $ 1,381,950 and $ 618,011 were deposited with various major reputable financial institutions located in the PRC and international financial institutions outside of the PRC.
+Added: Financial instruments that are potentially subject to credit risk consist of cash and cash equivalents short-term investments, and accounts receivable.
+Added: As of December 31, 2021 and 2020, $ 4,375,678 and $ 1,381,950 were deposited with various major reputable financial institutions located in the PRC and international financial institutions outside of the PRC, respectively.
The deposits placed with financial institutions are not protected by statutory or commercial insurance.
6 unchanged sentences
treasury securities are of high credit quality and continually monitors the credit worthiness of these institutions.
+Added: As of December 31, 2021 and 2020, the Company had accounts receivable, net of $ 483,113 and $ 60,403 , respectively.
+Added: Accounts receivable, net represent amounts arising from product sales and amounts due from the our collaboration partners.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+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 monitors economic conditions to identify facts or circumstances that may indicate receivables are at risk of collection.
Customer concentration risk
−Removed: 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.
−Removed: 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.
+Added: For the year ended December 31, 2021, sales to the Company's three largest product distributors, Sinopharm, China Resources, and Shanghai Pharmaceutical represented approximately 26.0 %, 19.9 % and 16.7 % of product revenue, respectively, and collectively, represented approximately 23.4 % of trade accounts receivable as of December 31, 2021.
+Added: For the year ended December 31, 2021, the Company's collaboration revenue consisted entirely of revenue recognized under its out-licensing collaboration agreements with Novartis.
+Added: Receivables from Novartis represented approximately 66.4 % of trade accounts receivable as of December 31, 2021, primarily due to the invoicing of the $ 300,000 upfront fee related to the Ociperlimab option, collaboration and license agreement.
+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 trade accounts receivable as of December 31, 2020.
+Added: For the year ended December 31, 2019, 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
12 unchanged sentences
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
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: convertible into U.S.
+Added: However, the unification of the exchange rates does not imply that the RMB may be readily convertible into U.S.
dollar or other foreign currencies.
5 unchanged sentences
For RMB against U.S.
−Removed: 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.
+Added: dollar, there was appreciation of approximately 2.3 %, appreciation of approximately 6.3 % and depreciation of approximately 1.3 %, in the years ended December 31, 2021, 2020 and 2019.
It is difficult to predict how market forces or PRC or U.S.
8 unchanged sentences
dollar amount available to the Company.
−Removed: In addition, a significant depreciation of the RMB against the U.S.
−Removed: dollar may significantly reduce the U.S.
−Removed: dollar equivalent of the Company’s earnings or losses.
−Removed: Recent Accounting Pronouncements
−Removed: New accounting standards which have been adopted
−Removed: In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses .
−Removed: 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 (collectively, the "Credit Loss ASUs").
−Removed: The Credit Loss ASUs change the methodology to be used to measure credit losses for certain financial instruments and financial assets, including trade receivables.
−Removed: 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.
−Removed: 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.
−Removed: The Company adopted the standard on January 1, 2020.
−Removed: 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.
−Removed: 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.
−Removed: In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820):
−Removed: Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurement.
−Removed: The update eliminates, modifies, and adds certain disclosure requirements for fair value measurements.
−Removed: 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.
−Removed: All other changes to disclosure requirements in this update should be applied retrospectively to all periods presented upon their effective date.
−Removed: The Company adopted this standard on January 1, 2020.
−Removed: There was no material impact to the Company's financial position or results of operations upon adoption.
−Removed: In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40):
−Removed: Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract.
−Removed: 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 guidance should be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption.
−Removed: The Company adopted this standard on January 1, 2020.
−Removed: 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: 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: This guidance should be applied retrospectively to the date of initial application of Topic 606.
−Removed: The Company adopted this standard on January 1, 2020.
−Removed: There was no material impact to the Company's financial position or results of operations upon adoption.
−Removed: New accounting standards which have not yet been adopted
+Added: addition, a significant depreciation of the RMB against the U.S.
+Added: dollar may significantly reduce the U.S.
+Added: dollar equivalent of the Company’s earnings or losses.
+Added: Recent Accounting Pronouncements
+Added: New accounting standards which have been adopted
In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740):
2 unchanged sentences
The amendments include removal of certain exceptions to the general principles of ASC 740, Income taxes, and simplification in several other areas such as accounting for a franchise tax (or similar tax) that is partially based on income.
−Removed: The update is effective in fiscal years beginning after December 15, 2020, and interim periods therein, and early adoption is permitted.
−Removed: Certain amendments in this update should be applied retrospectively or modified retrospectively, all other amendments should be applied prospectively.
−Removed: The Company is currently evaluating the impact on its financial statements of adopting this guidance.
+Added: Certain amendments in this update should be applied retrospectively or modified retrospectively, and all other amendments should be applied prospectively.
+Added: The Company adopted this standard on January 1, 2021.
+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
+Added: In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832):
+Added: Disclosures by Business Entities about Government Assistance.
+Added: This update requires certain annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy.
+Added: This update is effective for annual periods beginning after December 15, 2021, and early application is permitted.
+Added: This guidance should be applied either prospectively to all transactions that are reflected in financial statements at the date of initial application and new transactions that are entered into after the date of initial application or retrospectively to those transactions.
+Added: The Company does not expect the impact of this guidance to have a material impact on the Company’s consolidated financial statements.
Collaborative and Licensing Arrangements
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 products and drug candidates to other parties, in-licenses of products and drug candidates from other parties, and profit- and cost-sharing arrangements.
+Added: To date, these collaborative arrangements have included out-licenses of and options to out-license internally developed products and drug candidates to other parties, in-licenses of products and drug candidates from other parties, and profit- and cost-sharing arrangements.
These arrangements may include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost-sharing and reimbursement arrangements, royalty payments, and profit sharing.
Out-Licensing Arrangements
−Removed: To date, the Company’s collaboration revenue related to its out-licensing collaborative agreements has consisted of (1) upfront license fees, research and development reimbursement revenue, and research and development services revenue from its collaboration agreement with BMS for tislelizumab, and (2) upfront license fees and milestone payments from its collaboration agreement with Merck KGaA, Darmstadt Germany for pamiparib and lifirafenib.
+Added: During the three years ended December 31, 2021, the Company’s collaboration revenue related to its out-licensing collaborative agreements has consisted of upfront license fees, research and development services revenue and right to access intellectual property revenue from its collaboration agreements with Novartis for tislelizumab and ociperlimab and reimbursement of research and development costs, research and development service revenue and termination fees from its collaboration with BMS for tislelizumab.
The following table summarizes total collaboration revenue recognized for the years ended December 31, 2021, 2020 and 2019:
2 unchanged sentences
Revenue from Collaborators $ $ $
+Added: License revenue 484,646 — —
Reimbursement of research and development costs — — 27,634
Research and development service revenue 53,671 — 27,982
+Added: Right to access intellectual property revenue 3,979 — —
Other — — 150,000
6 unchanged sentences
except for number of shares and per share data)
+Added: Tislelizumab Collaboration and License
+Added: In January 2021, the Company entered into a collaboration and license agreement with Novartis, granting Novartis rights to develop, manufacture and commercialize tislelizumab in North America, Europe, and Japan (the "Novartis Territory").
+Added: The Company and Novartis have agreed to jointly develop tislelizumab in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals.
+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 received an upfront cash payment of $ 650,000 from Novartis.
+Added: The Company is eligible to receive up to $ 1,300,000 upon the achievement of regulatory milestones, $ 250,000 upon the achievement of sales milestones, and royalties on future sales of tislelizumab in the licensed territory.
+Added: Under the terms of the agreement, the Company is responsible for funding ongoing clinical trials of tislelizumab, Novartis has agreed to fund new registrational, bridging, or post-marketing studies in its territory, and each party will be responsible for funding clinical trials evaluating tislelizumab in combination with its own or third party products.
+Added: Each party retains the worldwide right to commercialize its propriety products in combination with tislelizumab.
+Added: The Company evaluated the Novartis agreement under ASC 606 as all the material units of account within the agreement represented transactions with a customer.
+Added: The Company identified the following material components under the agreement:
+Added: (1) exclusive license for Novartis to develop, manufacture, and commercialize tislelizumab in the Novartis Territory, transfer of know-how and use of the tislelizumab trademark;
+Added: (2) conducting and completing ongoing trials of tislelizumab (R&D services);
+Added: and (3) supplying Novartis with required quantities of the tislelizumab drug product, or drug substance, upon receipt of an order from Novartis.
+Added: The Company determined that the license, transfer of know-how and use of trademarks are not distinct from each other and represent a single performance obligation.
+Added: The R&D services represent a material promise and were determined to be a separate performance obligation at the outset of the agreement as the promise is distinct and has standalone value to Novartis.
+Added: The Company evaluated the supply component of the contract and noted the supply will not be provided at a significant incremental discount to Novartis.
+Added: The Company concluded that, for the purpose of ASC 606, the provision related to providing clinical and commercial supply of tislelizumab in the Novartis Territory was an option but not a performance obligation of the Company at the outset of the Novartis collaboration agreement.
+Added: A performance obligation for the clinical and commercial supply will be established as quantities of drug product or drug substance are ordered by Novartis.
+Added: The Company determined that the transaction price as of the outset of the arrangement was the upfront payment of $ 650,000 .
+Added: The potential milestone payments that the Company is eligible to receive were excluded from the transaction price, as all milestone amounts were fully constrained due to uncertainty of achievement.
+Added: The transaction price was allocated to the two identified performance obligations based on a relative fair value basis.
+Added: The standalone selling price of the license, transfer of know-how and use of trademarks performance obligation was determined using the adjusted market assessment approach based on the probability-weighted present value of forecasted cash flows associated with out-licensing tislelizumab in the Novartis Territory.
+Added: The standalone selling price of the R&D services was valued using a cost plus margin valuation approach based on the present value of estimated tislelizumab clinical trial costs plus a reasonable margin.
+Added: Based on the relative standalone selling prices of the two performance obligations, $ 484,646 of the total transaction price was allocated to the license and $ 165,354 was allocated to the R&D services.
+Added: The estimates of the standalone selling prices involved management's key assumptions such as revenue growth rate, estimated clinical trial costs, mark-up rate, probability of technical and regulatory success, and discount rates.
+Added: These significant assumptions are forward looking and could be affected by future economic, regulatory and market conditions.
+Added: The Company satisfied the license performance obligation at a point in time when the license was delivered and the transfer of know-how completed which occurred during the year ended December 31, 2021.
+Added: As such, the Company recognized the entire amount of the transaction price allocated to the license as collaboration revenue during the year ended December 31, 2021.
+Added: The portion of the transaction price allocated to the R&D services was deferred and is being recognized as collaboration revenue as the R&D services are performed using a percentage-of-completion method.
+Added: Estimated costs to complete are reassessed on a periodic basis and any updates to the revenue earned are recognized on a prospective basis.
+Added: The Company recognized R&D service revenue of $ 53,421 during the year ended December 31, 2021.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: Ociperlimab Option, Collaboration and License Agreement and China Broad Market Development Agreement
+Added: In December 2021, the Company expanded its collaboration with Novartis by entering into an option, collaboration and license agreement with Novartis to develop, manufacture and commercialize the Company's investigational TIGIT inhibitor ociperlimab in the Novartis Territory.
+Added: In addition, the Company and Novartis entered into an agreement granting the Company rights to market, promote and detail five approved Novartis oncology products, TAFINLAR ® (dabrafenib), MEKINIST ® (trametinib), VOTRIENT ® (pazopanib), AFINITOR ® (everolimus), and ZYKADIA ® (ceritinib), across designated regions of China referred to as “broad markets.”
+Added: Under the terms of the option, collaboration and license agreement, the Company received an upfront cash payment of $ 300,000 in January 2022 from Novartis and will receive an additional payment of $ 600,000 or $ 700,000 in the event Novartis exercises its exclusive time-based option prior to mid-2023 or between then and late-2023, respectively.
+Added: Following option exercise, the Company is eligible to receive up to $ 745,000 upon the achievement of regulatory approval milestones, $ 1,150,000 upon the achievement of sales milestones, and royalties on future sales of ociperlimab in the Novartis Territory.
+Added: Subject to the terms of the option, collaboration and license agreement, during the option period, Novartis has agreed to initiate and fund additional global clinical trials with ociperlimab and the Company has agreed to expand enrollment in two ongoing trials.
+Added: Following the option exercise, Novartis has agreed to share development costs of global trials.
+Added: Following approval, the Company has agreed to provide 50 percent of the co-detailing and co-field medical efforts in the United States, and has an option to co-detail up to 25 percent in Canada and Mexico, funded in part by Novartis.
+Added: Each party retains the worldwide right to commercialize its propriety products in combination with ociperlimab, as is the case with tislelizumab under the tislelizumab collaboration and license agreement.
+Added: The existing tislelizumab collaboration and license agreement was not modified as a result of the ociperlimab option, collaboration and license agreement.
+Added: The Company evaluated the Novartis agreements under ASC 606 as the units of account within the agreement represented transactions with a customer.
+Added: The Company identified the following material promises under the agreement:
+Added: (1) exclusive option for Novartis to license the rights develop, manufacture, and commercialize ociperlimab in the Novartis Territory;
+Added: (2) Novartis' right to access ociperlimab in its own clinical trials during the option period;
+Added: (3) initial transfer of BeiGene know-how;
+Added: and (4) conducting and completing ongoing trials of ociperlimab during the option period (R&D Services).
+Added: The market development activities are considered immaterial in the context of the contracts.
+Added: The Company concluded that, at the inception of the agreement, the option for the exclusive product license constitutes a material right as it represents a significant and incremental discount to the fair value of the exclusive product license that Novartis would not have received without entering into the agreement and is therefore considered a distinct performance obligation.
+Added: The Company determined that Novartis' right to access ociperlimab in its own trials over the option period and the initial transfer of know-how were not distinct from each other, as the right to access ociperlimab has limited value without the corresponding know-how transfer, and therefore should be combined into one distinct performance obligation.
+Added: The R&D Services represent a material promise and were determined to be a separate performance obligation at the outset of the agreement as the promise is distinct and has standalone value to Novartis.
+Added: The Company determined the transaction price as of the outset of the arrangement was the upfront payment of $ 300,000 .
+Added: The option exercise fee is contingent upon Novartis exercising its right and is considered fully constrained until the option is exercised.
+Added: Additionally, the milestone and royalty payments are not applicable until after the option is exercised, at which point the likelihood of meeting milestones, regulatory approval and meeting certain sales thresholds will be assessed.
+Added: T he transaction price was allocated to the three identified performance obligations based on a relative fair value basis.
+Added: The standalone selling price of the material right for the option to the exclusive product license was calculated as the incremental discount between (i) the value of the license determined using a discounted cash flow method adjusted for probability of the option being exercised and (ii) the expected option exercise fee using the most-likely-amount method at option exercise.
+Added: The standalone selling price of the combined performance obligation for Novartis' right to access ociperlimab for its own clinical trials during the option period and the initial transfer of BeiGene know-how was determined using a discounted cash flow method.
+Added: The standalone selling price of the R&D Services was determined using an expected cost plus margin approach.
+Added: Based on the relative standalone selling prices of the three performance obligations, $ 71,980 of the total transaction price was allocated to the material right, $ 213,450 was allocated to Novartis' right to use ociperlimab in its own clinical trials during the option period and the transfer of BeiGene know-how, and $ 14,570 was allocated to the R&D Services.
+Added: The Company will satisfy the material right performance obligation at a point in time at the earlier of when Novartis exercises the option and the license is delivered or the expiration of the option period.
+Added: As such, the entire amount of the
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: transaction price allocated to the material right was deferred.
+Added: The portion of the transaction price allocated to Novartis' right to access ociperlimab in its own clinical trials during the option period and the initial transfer of BeiGene know-how was deferred and is being recognized over the expected option period.
+Added: The portion of the transaction price allocated to the R&D Services was deferred and is being recognized as collaboration revenue as the R&D Services are performed over the expected option period.
+Added: The Company recognized collaboration revenue of $ 3,979 related to Novartis right to access ociperlimab in clinical trials and the transfer of know how performance obligation and R&D service revenue of $ 250 during the year ended December 31, 2021.
Celgene Corporation, a Bristol Myers Squibb company (BMS)
17 unchanged sentences
The Company's license from BMS to distribute the approved cancer therapies ABRAXANE ® , REVLIMID ® , and VIDAZA ® in China was not affected by the termination of the tislelizumab collaboration.
−Removed: For the year ended December 31, 2019, the Company recognized collaboration revenue of $ 205,616 related to the BMS collaboration, which consisted of $ 27,634 of research and development reimbursement revenue for the trials that BMS had opted into through the termination of the collaboration agreement;
−Removed: $ 27,982 of research and development services revenue, which reflects the recognition of the remaining upfront consideration that was allocated to research and development services at the time of the collaboration and was recognized over the term of the respective clinical studies for the specified indications;
−Removed: and $ 150,000 of other collaboration revenue related to the payment received from BMS in connection with the termination of the collaboration agreement.
−Removed: 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.
+Added: On March 25, 2020, the NMPA suspended the importation, sales and use of ABRAXANE ® in China supplied to us by BMS, and the drug was subsequently recalled by BMS and is not currently available for sale in China.
+Added: This suspension was based on inspection findings at BMS’s contract manufacturing facility in the United States.
+Added: Additionally, in October 2021, BMS provided 180-days' notice to us, which we dispute, purporting to terminate our license to market ABRAXANE ® in China.
+Added: We have not had any sales of ABRAXANE ® since the suspension and do not expect future revenue from ABRAXANE ® .
+Added: We have initiated an
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−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.
−Removed: 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.
−Removed: On October 1, 2015, the Company entered into a purchase of rights agreement with Merck KGaA, Darmstadt Germany, pursuant to which the Company purchased from Merck KGaA, Darmstadt Germany all of its exclusive rights to pamiparib in the ex-PRC territories for consideration of $ 10,000 , and reduced the future milestone payments the Company was eligible to receive under the PRC license agreement.
−Removed: In December 2017, the Company achieved the milestone for dosing a patient in the first Phase 2 clinical trial of pamiparib in the PRC Territory, and the related $ 1,000 milestone payment received in January 2018, was recognized as research and development services revenue in year ended December 31, 2017.
−Removed: In May 2018, the Company achieved the milestone for dosing patients in the first Phase 3 clinical trial of pamiparib in the PRC Territory, and the related $ 1,500 milestone payment was recognized as research and development services revenue for the year ended December 31, 2018.
−Removed: No other milestones were achieved prior to the termination of the agreement.
−Removed: 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.
−Removed: 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.
−Removed: Merck KGaA, Darmstadt Germany was relieved of any future milestone obligations as a result of the termination.
−Removed: 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.
−Removed: All other future obligations were terminated.
−Removed: 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.
+Added: arbitration proceeding against BMS asserting that it has breached and continues to breach the terms and conditions of the license and supply agreement.
+Added: For additional information, please see the section of this report titled “Legal Proceedings”.
+Added: For the year ended December 31, 2019, the Company recognized collaboration revenue of $ 205,616 related to the BMS collaboration, which consisted of $ 27,634 of research and development reimbursement revenue for the trials that BMS had opted into through the termination of the collaboration agreement;
+Added: $ 27,982 of research and development services revenue, which reflects the recognition of the remaining upfront consideration that was allocated to research and development services at the time of the collaboration and was recognized over the term of the respective clinical studies for the specified indications;
+Added: and $ 150,000 of other collaboration revenue related to the payment received from BMS in connection with the termination of the collaboration agreement.
In-Licensing Arrangements - Commercial
−Removed: 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.
−Removed: On January 2, 2020, following approval by the Company's shareholders and satisfaction of other closing conditions, the agreement became effective.
+Added: In October 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 Macau, of Amgen’s XGEVA ® , KYPROLIS ® , and BLINCYTO ® , and the joint global development of a portfolio of oncology assets in Amgen’s pipeline, with BeiGene responsible for development and commercialization in China.
+Added: The agreement became effective on January 2, 2020, following approval by the Company's shareholders and satisfaction of other closing conditions.
Under the agreement, the Company is responsible for the commercialization of XGEVA ® , KYPROLIS ® and BLINCYTO ® in China for five or seven years .
−Removed: Amgen is responsible for manufacturing of the products globally and will supply the products to the Company at an agreed upon price.
+Added: Amgen is responsible for manufacturing the products globally and will supply the products to the Company at an agreed upon price.
The Company and Amgen will share equally in the China commercial profits and losses during the commercialization period.
−Removed: Following the commercialization period, the Company has the right to retain one
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: product and is entitled to receive royalties on sales in China for an additional five years on the products not retained.
−Removed: 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: Following the commercialization period, the Company has the right to retain one product and is entitled to receive royalties on sales in China for an additional five years on the products not retained.
+Added: XGEVA ® was approved in China in 2019 for patients with giant cell tumor of the bone and in November 2020 for the prevention of skeletal-related events in cancer patients with bone metastases.
In July 2020, the Company began commercializing XGEVA ® in China.
In December 2020, BLINCYTO ® was approved in China for injection for the treatment of adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL).
−Removed: Additionally, a new drug application has been filed in China for KYPROLIS ® as a treatment for patients with multiple myeloma.
+Added: In July 2021, KYPROLIS ® was conditionally approved in China for injection in combination with dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma.
Amgen and the Company are also jointly developing a portfolio of Amgen oncology pipeline assets under the collaboration.
2 unchanged sentences
For each pipeline asset that is approved in China, the Company will receive commercial rights for seven years from approval.
−Removed: 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 has the right to retain approximately one out of every three approved pipeline assets, other than LUMAKRAS™ (sotorasib), Amgen's KRAS G12C inhibitor, for commercialization in China.
The Company and Amgen will share equally in the China commercial profits and losses during the commercialization period.
The Company is entitled to receive royalties from sales in China for pipeline assets returned to Amgen for five years after the seven-year commercialization period.
−Removed: The Company is also entitled to receive royalties from global sales of each product outside of China (with the exception of sotorasib).
+Added: The Company is also entitled to receive royalties from global sales of each product outside of China (with the exception of LUMAKRAS™).
The Amgen Collaboration Agreement is within the scope of ASC 808, as both parties are active participants and are exposed to the risks and rewards dependent on the commercial success of the activities performed under the agreement.
7 unchanged sentences
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.
−Removed: Per the SPA, the cash proceeds shall be used as necessary to fund the Company's development obligations under the Amgen Collaboration Agreement.
+Added: Per the SPA, the cash proceeds
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: shall be used as necessary to fund the Company's development obligations under the Amgen Collaboration Agreement.
Pursuant to the SPA, Amgen also received the right to designate one member of the Company's board of directors, and Anthony Hooper joined the Company's board of directors as the Amgen designee in January 2020.
11 unchanged sentences
Total cash proceeds 2,779,241
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: 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: Amounts recorded related to the Company's portion of the co-development funding on the pipeline assets for the year ended December 31, 2021 and 2020 were as follows:
Year Ended December 31,
2 unchanged sentences
Total amount due to Amgen for BeiGene's portion of the development funding 227,950 230,991
−Removed: Total amount of development funding paid or payable in cash 224,396
−Removed: Total amount of development funding paid with development services 6,595
As of December 31, 2021
Remaining portion of development funding cap 791,059
−Removed: 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, 2021 and 2020, the research and development cost share liability recorded in the Company's balance sheet was as follows:
As of December 31,
2 unchanged sentences
Total research and development cost share liability 390,362 502,848
−Removed: 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: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: The net reimbursement due under the commercial profit-sharing agreement for in-line product sales is classified in the consolidated statements of operations for the year ended December 31, 2021 and 2020 as follows:
Year Ended December 31,
3 unchanged sentences
Total ( 42,836 ) ( 11,620 )
−Removed: Celgene Logistics Sàrl, a BMS company
−Removed: 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”).
−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 began distributing these in-licensed products in China in September 2017.
−Removed: The Company subsequently assigned the agreement to its wholly-owned subsidiary, BeiGene Switzerland.
+Added: The Company purchases commercial inventory from Amgen to distribute in China.
+Added: Total inventory purchases amounted to $ 110,303 and $ 38,392 , respectively, during the year ended December 31, 2021 and 2020.
+Added: Net amounts payable to Amgen as of December 31, 2021 and 2020 were $ 106,790 and $ 122,828 , respectively.
In-Licensing Arrangements - Development
1 unchanged sentence
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.
+Added: Upfront and milestone payments made under these arrangements for the years ended December 31, 2021, 2020 and 2019 are set forth below.
+Added: All upfront and development milestones were expensed to research and development expense.
+Added: All regulatory and commercial milestones were capitalized as intangible assets and are being amortized over the remainder of the respective product patent or the term of the commercialization agreements.
+Added: Year Ended December 31,
+Added: 2021 2020 2019
+Added: Payments due to collaboration partners Classification $ $ $
+Added: Upfront payments Research and development expense 83,500 109,500 50,000
+Added: Development milestone payments Research and development expense 15,000 15,800 —
+Added: Regulatory and commercial milestone payments Intangible asset 43,394 — —
+Added: Total 141,894 125,300 50,000
+Added: Our significant license agreements are described below:
+Added: Shoreline Biosciences, Inc.
+Added: In June 2021, the Company entered into an exclusive worldwide strategic collaboration with Shoreline Biosciences, Inc.
+Added: (Shoreline) to develop and commercialize a portfolio of natural killer (NK)-based cell therapeutics with Shoreline's induced pluripotent stem cells (iPSC) NK cell technology and the Company's research and clinical development capabilities for different malignancies.
+Added: Under the collaboration, the Company and Shoreline are working jointly to develop cell therapies for four designated therapeutic targets, with an option to expand the collaboration at a future date.
+Added: Clinical development is being led by the Company globally, with Shoreline responsible for clinical manufacturing.
+Added: The Company has commercial rights globally, with Shoreline having an option to retain commercialization rights in the United States and Canada for two targets.
+Added: Under the terms of the agreement, Shoreline received a $ 45,000 upfront payment in January 2022 and is eligible to receive additional R&D funding, milestone payments and royalties based upon the achievement of certain development, regulatory, and commercial milestones.
+Added: The upfront payment was expensed to research and development expense during the year ended December 31, 2021 in accordance with the Company's acquired in-process research and development expense policy.
+Added: Nanjing Leads Biolabs, Inc.
+Added: In December 2021, the Company entered into a license and collaboration agreement with Nanjing Leads Biolabs, Inc.
+Added: (Leads Biolabs) for worldwide research, development and manufacturing rights and exclusive commercialization rights outside
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: Our significant license agreements are described below:
+Added: of China to LBL-007, a novel investigational antibody targeting the LAG-3 pathway.
+Added: Under the terms of the agreement, Leads Biolabs received an upfront payment of $ 30,000 in January 2022 and is eligible to receive up to $ 742,000 in clinical development, regulatory approval and sales milestones.
+Added: Leads Biolabs is also eligible to receive tiered royalties on future sales in the licensed territory.
+Added: The upfront payment was expensed to research and development expense during the year ended December 31, 2021 in accordance with the Company's acquired in-process research and development expense policy.
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.
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 will fund and undertake all clinical development and regulatory submissions in the territories, and will commercialize both products once approved.
−Removed: 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 .
−Removed: EUSA will also be eligible to receive tiered royalties on future product sales.
+Added: Under the agreement, the Company is funding and undertaking all clinical development and regulatory submissions in the territories, and commercializing both products once approved.
+Added: EUSA received a $ 40,000 upfront payment upon contract execution and is eligible to receive additional payments upon the achievement of regulatory and commercial milestones up to a total of $ 120,000 .
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 2021, QARZIBA ® and SYLVANT ® were approved and launched in mainland China and greater China, respectively.
+Added: The approvals triggered regulatory milestone payments that were capitalized as intangible assets and are being amortized over the remaining term of the license agreement.
+Added: EUSA is receiving tiered royalties on SYLVANT ® product sales, which the Company records as cost of sales in the period the respective sales are generated.
Assembly Biosciences, Inc.
9 unchanged sentences
In August 2020, the Company entered into a license, distribution and supply agreement with Bio-Thera Solutions, Ltd.
−Removed: ("Bio-Thera") for Bio-Thera's BAT1706, an investigational biosimilar to Avastin ® (bevacizumab) in China.
+Added: (Bio-Thera) for Bio-Thera's POBEVCY ® (BAT1706), a biosimilar to Avastin ® (bevacizumab) in China.
The agreement became effective on September 10, 2020 upon approval of Bio-Thera's shareholders, and was subsequently assigned by the Company to its affiliate BeiGene (Guangzhou) Co., Ltd.
(BeiGene Guangzhou) on September 18, 2020, as permitted by the agreement.
−Removed: 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.
−Removed: Bio-Thera will retain rights outside of the partnered territory.
+Added: Under the terms of the agreement, Bio-Thera agreed to grant BeiGene the right to develop, manufacture, and commercialize POBEVCY ® in China, including Hong Kong, Macau, and Taiwan.
+Added: Bio-Thera retained rights outside of the partnered territory.
Bio-Thera received an upfront payment of $ 20,000 in October 2020 and is eligible to receive payments upon the achievement of regulatory and commercial milestones up to a total of $ 145,000 .
−Removed: Bio-Thera will also be eligible to receive tiered double digit royalties on future net product sales.
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 2021, POBEVCY ® obtained regulatory approval, and was subsequently launched, in China, triggering a milestone payment that was capitalized as an intangible asset that is being amortized over the remaining term of the license agreement.
+Added: Bio-Thera is also receiving tiered royalties on product sales, which the Company records as cost of sales in the period the respective sales are generated.
In November 2019, the Company entered into a l icense agreement with Seagen, Inc.
2 unchanged sentences
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.
−Removed: The Company was granted exclusive rights to develop and commercialize the product candidate in Asia (except Japan) and the rest of the world.
−Removed: Seagen will lead global development and BeiGene will fund and operationalize the portion of global clinical trials attributable to its territories.
−Removed: BeiGene will also be responsible for all clinical development and regulatory submissions specific to its territories.
−Removed: Seagen received an upfront payment of $ 20,000 and is eligible to receive progress-dependent milestones and tiered royalties on any product sales.
−Removed: Seagen is a related party due to a common shareholder, and that shareholder has different representatives serving on each companies' respective board of directors.
−Removed: 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: The Company was granted exclusive rights to develop and
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: BioAtla, Inc.
−Removed: In April 2019, the Company entered into a global co-development and collaboration agreement with BioAtla, Inc.
−Removed: ("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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: commercialize the product candidate in Asia (except Japan) and the rest of the world.
+Added: Seagen will lead global development and BeiGene will fund and operationalize the portion of global clinical trials attributable to its territories.
+Added: BeiGene will also be responsible for all clinical development and regulatory submissions specific to its territories.
+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: In October 2020, the Company and BioAtla amended the global co-development and collaboration agreement.
−Removed: 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.
−Removed: 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: 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.
+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 HER2-targeted bispecific antibody candidate ZW25 (zanidatamab) 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.
Under the collaboration agreements, BeiGene will be responsible for all clinical development and regulatory submissions in the licensed territories.
−Removed: BeiGene and Zymeworks have also agreed to collaborate on global development of ZW25 and ZW49 in HER2‑expressing solid tumors, including gastric and breast cancer, with BeiGene enrolling patients and contributing clinical trial data from the licensed territories.
−Removed: Zymeworks retains full rights to both ZW25 and ZW49 outside of the specified countries and will continue to lead global development of these drug candidates.
−Removed: Under the terms of the license and collaboration agreements for ZW49 and ZW25, Zymeworks received total upfront payments of $ 40,000 and is eligible to receive additional payments upon the achievement of development and commercial milestones for both product candidates.
−Removed: In addition, Zymeworks will be eligible to receive tiered royalties on future sales of ZW25 and ZW49 in the licensed territory.
+Added: BeiGene and Zymeworks have also agreed to collaborate on global development of zanidatamab and ZW49 in HER2‑expressing solid tumors, including gastric and breast cancer, with BeiGene enrolling patients and contributing clinical trial data from the licensed territories.
+Added: Zymeworks retains full rights to both zanidatamab and ZW49 outside of the specified countries and will continue to lead global development of these drug candidates.
+Added: Under the terms of the license and collaboration agreements for ZW49 and zanidatamab, Zymeworks received total upfront payments of $ 40,000 and is eligible to receive additional payments upon the achievement of development and commercial milestones for both product candidates.
+Added: In addition, Zymeworks will be eligible to receive tiered royalties on future sales of zanidatamab and ZW49 in the licensed territory.
Under the terms of the research and license agreement for the Azymetric ™ and EFECT ™ platforms, Zymeworks received an upfront payment of $ 20,000 and is eligible to receive additional payments upon the achievement of development and commercial milestones for up to three bispecific product candidates developed under the agreement.
1 unchanged sentence
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: The Company recognized $ 15,000 of Zymeworks development milestone payments within research and development expense during the years ended December 31, 2020.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: In addition to the collaborations discussed above, the Company has entered into additional collaborative arrangements during the years ending December 31, 2020 and 2019.
+Added: The Company recognized development milestone payments related to the development of zanidatamab during the years ended December 31, 2021 and 2020 within research and development expense.
+Added: In addition to the collaborations discussed above, the Company has entered into additional collaborative arrangements during the years ended December 31, 2021 and 2020.
The Company may be required to pay additional amounts upon the achievement of various development and commercial milestones under these agreements.
2 unchanged sentences
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: Asset Acquisitions
−Removed: BeiGene Pharmaceuticals (Guangzhou) Co., Ltd.
−Removed: In September 2018, BeiGene (Guangzhou) Co., Ltd.
−Removed: ("BeiGene Guangzhou") acquired 100 % of the equity interests of Baiji Shenzhou (Guangzhou) Pharmaceuticals Co., Ltd.
−Removed: (formerly known as Huajian Pharmaceuticals Co., Ltd.), which subsequently changed its name to BeiGene Pharmaceuticals (Guangzhou) Co., Ltd., a pharmaceutical distribution company, for total cash consideration of $ 612 , including transaction costs of $ 59 .
−Removed: The acquisition was concentrated in a single identifiable asset, a drug distribution license, 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 was allocated to the drug distribution license and corresponding deferred tax liability, resulting in a $ 816 intangible asset for the license and a deferred tax liability of $ 204 .
−Removed: Beijing Innerway Bio-tech Co., Ltd.
−Removed: 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 .
−Removed: 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 of $ 211 , was allocated based on the relative fair values of the net assets acquired, as follows:
−Removed: Land use right 33,783
−Removed: Building 15,874
−Removed: Deferred tax liability ( 11,221 )
−Removed: Total cost 38,865
Restricted Cash
24 unchanged sentences
Equity Securities with Readily Determinable Fair Values
+Added: Leap Therapeutics, Inc.
In January 2020, the Company purchased $ 5,000 of Series B mandatorily convertible, non-voting preferred stock of Leap in connection with a strategic collaboration and license agreement the Company entered into with Leap.
The Series B shares were subsequently converted into shares of Leap common stock and warrants to purchase additional shares of common stock upon approval of Leap's shareholders in March 2020.
+Added: In September 2021, the Company purchased $ 7,250 of common stock in Leap's underwritten public offering.
As of December 31, 2021, the Company's ownership interest in the outstanding common stock of Leap was 8.3 % based on information from Leap.
−Removed: 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: Inclusive of the shares of common stock issuable upon the exercise of the currently exercisable warrants, the Company's interest is approximately 13.1 %.
The Company measures the investment in the common stock and warrants at fair value, with changes in fair value recorded to other income, net.
−Removed: The fair value of the common stock and warrants was $ 10,810 and $ 6,669 , respectively, as of December 31, 2020.
−Removed: During the year ended December 31, 2020, the Company recorded an unrealized gain of $ 12,479 in the consolidated statement of operations.
+Added: During the year ended December 31, 2021 and 2020, the Company recorded an unrealized gain of $ 9,386 and $ 12,479 , respectively, in the consolidated statement of operations.
+Added: As of December 31, 2021 and 2020, the fair value of the common stock and warrants was as follows:
+Added: As of December 31,
+Added: Fair value of Leap common stock 23,809 10,810
+Added: Fair value of Leap warrants 10,306 6,669
Private Equity Securities without Readily Determinable Fair Values
1 unchanged sentence
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.
−Removed: 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.
−Removed: There were no adjustments to the carrying values of these securities for the year ended December 31, 2020.
−Removed: Equity-Method Investments
−Removed: In June 2019, the Company announced the formation of MapKure, an entity jointly owned by the Company and SpringWorks Therapeutics, Inc.
−Removed: ("SpringWorks").
−Removed: The Company out-licensed to MapKure the Company's product candidate
+Added: The Company held investments of $ 43,722 and $ 9,705 in equity securities without readily determinable fair values as of December 31, 2021
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: 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: and 2020, respectively.
+Added: There were no adjustments to the carrying values of these securities for the year ended December 31, 2021 and 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 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.
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.
6 unchanged sentences
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.
−Removed: The Company recognized losses of $ 491 for its portion of MapKure's net loss for the year ended December 31, 2020.
−Removed: As of December 31, 2020, the carrying amount of the Company's investment in MapKure was $ 9,509 .
+Added: The Company recognized losses of $ 1,176 and $ 491 for the years ended December 31, 2021 and 2020, respectively.
+Added: As of December 31, 2021 and 2020, the carrying amount of the Company's investment in MapKure was $ 8,333 and 9,509 , respectively.
Guangzhou GET Phase I Biomedical Industry Investment Fund Partnership (Limited Partnership)
1 unchanged sentence
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.
−Removed: GET Bio-fund has four limited partners and one general partner, Guangzhou GET Biomedical Industry Investment Fund Management Co., Ltd.
+Added: GET Bio-fund has six limited partners and one general partner, Guangzhou GET Biomedical Industry Investment Fund Management Co., Ltd.
(GET Bio-fund Management).
1 unchanged sentence
The agreed upon duration may be extended for two additional years with the approval of all of the partners.
−Removed: BeiGene Guangzhou, as a limited partner, holds an ownership interest in the fund of 26.3 %.
+Added: As of December 31, 2021, BeiGene Guangzhou, as a limited partner, holds an ownership interest in the fund of 19.3 %.
The investment committee for the fund has seven members, and requires resolutions to be approved by at least five of the seven members.
1 unchanged sentence
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.
−Removed: The Company recognized losses of $ 68 for its portion of the fund's net loss for the year ended December 31, 2020.
−Removed: As of December 31, 2020, the carrying amount of the Company's investment in the fund was $ 12,189 .
+Added: The Company recognized losses of $ 145 and $ 68 for its portion of the fund's net loss for the years ended December 31, 2021 and 2020, respectively.
+Added: As of December 31, 2021 and 2020, the carrying amount of the Company's investment in the fund was $ 12,333 and $ 12,189 , respectively.
Other Equity-Method Investment
−Removed: 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.
−Removed: 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.
−Removed: The Company records its share of the investee's results of operations within other income, net.
+Added: In addition to the equity-method investments mentioned above, the Company made additional equity-method investments during the years ended December 31, 2021and 2020 that it does not consider to be individually significant to its financial statements.
+Added: The Company recognized the equity-method investments 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 investees' results of operations within other income, net.
BEIGENE, LTD.
12 unchanged sentences
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.
+Added: BeiGene Shanghai, originally established as a wholly-owned subsidiary of BeiGene (Hong Kong) Co., Ltd.
+Added: (BeiGene HK), and currently a wholly-owned subsidiary of BeiGene Biologics, as described below, provides clinical development services for BeiGene affiliates and is the clinical trial authorization (CTA) holder and marketing authorization application (MAA) holder for tislelizumab in China.
In March 2017, BeiGene HK, a wholly owned subsidiary of the Company, and Guangzhou GET Technology Development Co., Ltd.
3 unchanged sentences
GET made a cash capital contribution of RMB 100,000 to BeiGene Biologics, representing a 5 % equity interest in BeiGene Biologics.
−Removed: In addition, on March 7, 2017, BeiGene Biologics entered into a contract with GET, under which GET agreed to provide a RMB 900,000 loan (the “Shareholder Loan”) to BeiGene Biologics (see Note 14).
+Added: In addition, on March 7, 2017, BeiGene Biologics entered into a contract with GET, under which GET agreed to provide a RMB 900,000 loan (the “Shareholder Loan”) to BeiGene Biologics.
In September 2019, BeiGene Biologics completed the first phase of construction of a biologics manufacturing facility in Guangzhou, through a wholly owned subsidiary, the BeiGene Guangzhou Biologics Manufacturing Co., Ltd.
6 unchanged sentences
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.
−Removed: 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 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 ).
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.
1 unchanged sentence
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.
−Removed: 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: On October 9, 2021, the Company repaid $ 198,320 and drew down $ 200,000 from the Senior Loan .
+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
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: including principal, interest and fees.
+Added: (RMB 500,000 ) (Related Party Loan), of which $ 14,728 (RMB 100,000 ) can be used for general corporate purposes and $ 58,912 (RMB 400,000 ) can only be applied towards the repayment of the Senior Loan facility, including principal, interest and fees.
The Company has drawn down $ 15,693 (RMB 100,000 ) of the Related Party Loan as of December 31, 2021.
See Note 13 for further discussion of the loans.
−Removed: Commercial distribution legal entity structure
−Removed: BeiGene (Guangzhou) Co., Ltd.
−Removed: (“BGC”), a wholly-owned subsidiary of BeiGene HK, was organized in July 2017.
−Removed: In September 2018, BGC acquired 100 % of the equity interests of Baiji Shenzhou (Guangzhou) Pharmaceuticals Co., Ltd.
−Removed: (formerly known as Huajian Pharmaceuticals Co., Ltd.), which subsequently changed its name to BeiGene Pharmaceuticals (Guangzhou) Co., Ltd.
−Removed: 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, as it is difficult to obtain a newly issued domestic drug distribution license in China.
−Removed: The transaction was accounted for as an asset acquisition (see Note 4).
−Removed: Commercial supply agreement and facility expansion
−Removed: In January 2018, the Company entered into a commercial supply agreement with Boehringer Ingelheim Biopharmaceuticals (China) Ltd.
−Removed: (“Boehringer Ingelheim”) for tislelizumab, which is being manufactured at Boehringer Ingelheim’s facility in Shanghai, China as part of a Marketing Authorization Holder (“MAH”) trial project pioneered by the Company and Boehringer Ingelheim.
−Removed: Under the terms of the commercial supply agreement, Boehringer Ingelheim has agreed to manufacture tislelizumab in China under an exclusive multi-year arrangement, with contract extension possible.
−Removed: In addition, the Company obtained certain preferred rights for future capacity expansion by Boehringer Ingelheim in China.
−Removed: 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 made an additional payment for contingency costs in 2020.
−Removed: These payments will be credited against future purchases of tislelizumab over the term of the supply agreement.
−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 term of the supply agreement.
The Company has operating leases for office and manufacturing facilities in the United States, Switzerland, and China.
The leases have remaining lease terms of up to five years , some of which include options to extend the leases that have not been included in the calculation of the Company’s lease liabilities and ROU assets.
−Removed: The Company has land use rights, which represent land acquired for the biologics manufacturing facility in Guangzhou, and the land acquired for the Company's research, development and office facility in Changping, Beijing.
−Removed: A second Guangzhou land use right was acquired in May 2019 for potential expansion of the Company's research and development activities.
−Removed: The Company acquired a land use right in Suzhou in April 2020 to expand its research, development and manufacturing facility.
−Removed: 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.
+Added: The Company has land use rights, which represent land acquired for the biologics manufacturing facility in Guangzhou, the land acquired for the Company's research, development and office facility in Changping, Beijing, and the land acquired for the Company's research, development and manufacturing facility in Suzhou.
+Added: The land use rights represent lease prepayments and are expensed over the remaining term of the rights, which is 50 years for the Guangzhou land use rights, 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.
1 unchanged sentence
Year Ended December 31,
+Added: 2021 2020 2019
Operating lease cost 22,536 18,271 13,980
2 unchanged sentences
Total lease cost 29,251 21,754 16,765
−Removed: Total expenses under operating leases were $ 8,930 for the year ended December 31, 2018.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Supplemental balance sheet information related to leases was as follows:
12 unchanged sentences
Year ending December 31, 2026 1,546
−Removed: Thereafter 255
Total lease payments 70,218
1 unchanged sentence
Present value of lease liabilities 64,966
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Other supplemental information related to leases is summarized below:
Year ended December 31,
+Added: 2021 2020 2019
Operating cash flows used in operating leases 19,962 17,571 12,405
3 unchanged sentences
Weighted-average discount rate 5.15 % 6.26 %
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: Property, Plant and Equipment
−Removed: Property, plant and equipment are recorded at cost less accumulated depreciation and consisted of the following:
+Added: Property, Plant and Equipment, Net
+Added: Property, plant and equipment, net are recorded at cost less accumulated depreciation and consisted of the following:
As of December 31,
+Added: Land 65,485 —
Laboratory equipment 118,203 78,640
7 unchanged sentences
Property, plant and equipment, net 587,605 357,686
−Removed: 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: In November 2021, the Company purchased a 42 -acre site located in Hopewell, NJ for $ 75,197 .
+Added: The total purchase price was allocated between the land and an existing building on the property based on their relative fair values.
+Added: The Company plans to construct a biologics manufacturing facility and research and development center on the land.
+Added: Construction had not yet commenced as of December 31, 2021.
+Added: Construction in progress (CIP) a s of December 31, 2021 and 2020 primarily related to the buildout of additional capacity at the Guangzhou and Suzhou manufacturing facilities.
CIP by fixed asset class are summarized as follows:
6 unchanged sentences
Depreciation expense for the years ended December 31, 2021, 2020 and 2019 were $ 44,742 , $ 30,943 and $ 17,291 , respectively.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Intangible Assets
8 unchanged sentences
Product distribution rights 7,500 ( 3,250 ) 4,250 7,500 ( 2,500 ) 5,000
+Added: Developed products 43,394 ( 965 ) 42,429 — — —
Trading license 816 ( 816 ) — 816 ( 816 ) —
Total finite-lived intangible assets 51,710 ( 5,031 ) 46,679 8,316 ( 3,316 ) 5,000
−Removed: Product distribution rights consist of distribution rights for the approved cancer therapies licensed from BMS acquired as part of the BMS collaboration.
−Removed: The Company is amortizing the product distribution rights over a period of 10 years from the date of acquisition.
−Removed: The trading license represents the Guangzhou drug distribution license acquired in September 2018.
+Added: Product distribution rights consist of distribution rights for the approved cancer therapies licensed from BMS as part of the BMS collaboration.
+Added: The Company is amortizing the product distribution rights, as a single identified asset, over a period of 10 years from the date of acquisition.
+Added: Developed products represent the post-approval milestone payments under the license agreement with Merck KGaA that was terminated during the year ended December 31, 2018 and the license and commercialization agreements with EUSA Pharma and Bio-Thera.
+Added: The Company is amortizing the developed products over the remainder of the respective product patent or the term of the commercialization agreements.
+Added: Trading license represents the Guangzhou drug distribution license acquired in September 2018.
The Company amortized the drug distribution trading license over the remainder of the initial license term through February 2020.
The trading license has been renewed through February 2024.
+Added: Amortization expense for developed products is included in cost of sales - product in the accompanying consolidated statements of operations.
+Added: Amortization expense for product distribution rights and trading licenses is included in operating expenses in the accompanying consolidated statements of operations.
+Added: The weighted-average life for each finite-lived intangible assets is approximately 13 years.
+Added: Amortization expense is as follows:
+Added: Year Ended December 31,
+Added: 2021 2020 2019
+Added: Amortization expense - Cost of sales - product
+Added: Amortization expense - Operating expense
+Added: 750 846 1,326
+Added: Total 1,715 846 1,326
+Added: Estimated amortization expense for each of the five succeeding years and thereafter, as of December 31, 2021 is as follows:
+Added: Year Ending December 31, Cost of Sales - Product Operating Expenses Total
+Added: 3,314 750 4,064
+Added: 2023 3,314 750 4,064
+Added: 2024 3,314 750 4,064
+Added: 2025 3,314 750 4,064
+Added: 2026 3,314 750 4,064
+Added: 2027 and thereafter 25,859 500 26,359
+Added: Total 42,429 4,250 46,679
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: Amortization expense of intangible assets for the years ended December 31, 2020, 2019 and 2018 was $ 846 , $ 1,326 and $ 894 , respectively.
−Removed: 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.
The components of income ( loss) before income taxes are as follows:
16 unchanged sentences
( 47,094 ) ( 27,030 ) ( 4,715 )
+Added: Other ( 1,704 ) — —
Total ( 41,282 ) ( 28,182 ) ( 9,453 )
Income Tax (Benefit) Expense ( 25,234 ) ( 17,671 ) 6,992
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
The reconciliation of the statutory tax rate to our effective income tax rate is as follow:
12 unchanged sentences
Effective tax rate 1.8 % 1.1 % ( 0.7 ) %
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Significant components of deferred tax assets (liabilities) are as follows:
18 unchanged sentences
For the years ended December 31, 2021 and 2020 , there were increases in the valuation allowance of $ 210,306 and $ 209,085 , respectively.
−Removed: 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, 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
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: 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.
−Removed: that has indefinite carryforward.
+Added: Adjustments may 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.
+Added: As of December 31, 2021 and 2020 , the Company had net operating losses of approximately $ 3,644,005 and $ 2,230,857 , respectively.
+Added: As of December 31, 2021, net operating losses were primarily comprised of:
+Added: $ 942,541 from entities in the PRC which expire in years 2023 through 2031;
+Added: $ 2,325,359 derived from Switzerland which expires in years 2025 through 2028;
+Added: and, $ 351,645 derived from entities in the United States that have an indefinite carryforward.
The Company has approximately $ 88,632 of U.S.
9 unchanged sentences
Ending balance, as of December 31 9,925 7,123 4,633
−Removed: Current and prior year additions include assessment of U.S.
+Added: Current and prior year additions include an assessment of U.S.
federal and state tax credits and incentives.
−Removed: None of the unrecognized tax benefits as of December 31, 2020 would impact the consolidated income tax rate if ultimately recognized due to valuation allowances.
+Added: None of the unrecognized tax benefits as of December 31, 2021 would impact the consolidated income tax rate if ultimately recognized due
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: to valuation allowances.
The Company does not anticipate that the amount of existing unrecognized tax benefits will significantly change within the next 12 months.
2 unchanged sentences
The Company conducts business in a number of tax jurisdictions and, as such, is required to file income tax returns in multiple jurisdictions globally.
−Removed: As of December 31, 2020, Australia tax matters are open to examination for the years 2013 through 2020, China tax matters are open to examination for the years 2014 through 2020, and U.S.
+Added: As of December 31, 2021, Australia tax matters are open to examination for the years 2013 through 2021, China tax matters are open to examination for the years 2011 through 2021, Switzerland tax matters are open to examination for the years 2018 through 2021, and U.S.
federal tax matters are open to examination for years 2015 through 2021.
1 unchanged sentence
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 2022.
−Removed: 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: The income tax benefits attributable to this status for the year ended December 31, 2021 is approximately $ 2,863 , or less than $ 0.01 per share outstanding.
During the years ended December 31, 2021 and 2020, 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.
−Removed: 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.
+Added: As of December 31, 2021, the Company asserts indefinite reinvestment on the excess of the financial reporting bases over tax bases in the Company's investments in foreign subsidiaries to the extent reversal would incur a significant tax liability.
A deferred tax liability has not been established for the approximately $ 1,844 of cumulative undistributed foreign earnings.
−Removed: 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: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
+Added: Determination of the unrecognized deferred tax liability is not practicable due to the uncertainty and overall complexity of the hypothetical calculation.
Supplemental Balance Sheet Information
Changes in the allowance for credit losses related to trade accounts receivable consist of the following:
−Removed: Allowance for Credit Losses
−Removed: Balance as of December 31, 2019 —
+Added: Year Ended December 31,
+Added: Beginning balance, as of January 1 112 —
Provision charged to selling, general and administrative expenses 309 109
1 unchanged sentence
Exchange rate changes ( 6 ) 3
−Removed: Balance as of December 31, 2020 112
+Added: Ending balance, as of December 31 415 112
Prepaid expenses and other current assets consist of the following:
2 unchanged sentences
Prepaid taxes 58,579 30,392
−Removed: Payroll tax receivable 3,580 5,365
−Removed: Non-trade receivable 4,464 —
+Added: Other receivables 12,010 12,651
Interest receivable 5,052 6,619
1 unchanged sentence
Prepaid manufacturing cost 78,538 25,996
−Removed: Income tax receivable 4,607 —
−Removed: Other 11,666 3,017
+Added: Other current assets 27,060 11,666
Total 270,173 160,012
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Other non-current assets consist of the following:
7 unchanged sentences
Total 163,049 113,090
−Removed: (1) Represents payments for a facility expansion under a commercial supply agreement.
−Removed: The payment will provide future benefit to the Company through credits on future supply purchases as further described in Note 8.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
+Added: (1) Represents payments for facility expansion under commercial supply agreements.
+Added: The payments are providing future benefit to the Company through credits on commercial supply purchases.
Accrued expenses and other payables consisted of the following:
11 unchanged sentences
Pension liability 7,814 8,113
−Removed: Other 177 171
Total other long-term liabilities 54,234 57,429
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The following table summarizes the Company's short-term and long-term debt obligations as of December 31, 2021 and 2020:
−Removed: Lender Agreement Date Line of Credit Term Maturity Date Interest Rate December 31, 2020 December 31, 2019
+Added: Lender Agreement Date Line of Credit Term Maturity Date Interest Rate As of December 31,
China Construction Bank April 4, 2018 RMB 580,000 9 -year
April 4, 2027 (1) 1,255 8,000 307 2,000
+Added: China Merchants Bank January 22, 2020 (2) 9 -year
+Added: January 20, 2029 (2) 1,569 10,000 — —
China Minsheng Bank (the "Senior Loan") September 24, 2020 $ 200,000 (3) 4.5 % 200,000 1,274,535 198,320 1,294,010
4 unchanged sentences
April 4, 2027 (1) 89,444 570,000 88,584 578,000
−Removed: Industrial Bank Co.
−Removed: September 3, 2019 RMB 348,000 3 -year
−Removed: (5) 4.9 % — — — —
China Merchants Bank January 22, 2020 (2) 9 -year
2 unchanged sentences
November 8, 2029 (6) 59,316 378,000 41,412 270,206
−Removed: Total long-term bank loans 183,637 1,198,206 83,311 580,000
−Removed: GET (the "Shareholder Loan") March 7, 2017 RMB 900,000 (8) September 28, 2020 8.0 % — — 157,384 900,000
−Removed: Shareholder loan — — 157,384 900,000
+Added: Total long-term debt 202,113 1,288,000 183,637 1,198,206
The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC.
The loan interest rate was 4.9 % as of December 31, 2021.
+Added: The Company repaid $ 312 (or RMB 2,000 ) during the year ended December 31, 2021 .
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: 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, 2021.
$ 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.
−Removed: The Senior Loan has an original maturity date of October 8, 2021, which is the first anniversary of the first date of utilization of
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
+Added: The Senior Loan had an original maturity date of October 8, 2021, which was the first anniversary of the first date of utilization of the loan.
The Company may extend the original maturity date for up to two additional twelve month periods.
−Removed: 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: On October 8, 2021, the Company extended the maturity date for twelve months to October 8, 2022 and repurposed the Senior Loan for general working capital purposes.
+Added: On October 9, 2021, the Company repaid $ 198,320 and drew down $ 200,000 from the Senior Loan .
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.
−Removed: The loan matures at the earlier of:
+Added: The loan originally matured at the earlier of:
(i) November 9, 2021, which is one month after the Senior Loan maturity date, if not extended, or (ii) 10 business days after the Senior Loan is fully repaid.
−Removed: On September 30, 2020, the Company drew down the first tranche of $ 14,728 (RMB 100,000 ).
+Added: On October 8, 2021, the Company extended the maturity date of the Related Party Loan to the earlier of:
+Added: (i) November 9, 2022, which is one month after the Senior Loan maturity date, if not extended, or (ii) 10 business days after the Senior Loan is fully repaid.
Zhuhai Hillhouse is a related party of the Company, as it is an affiliate of Hillhouse Capital.
Hillhouse Capital is a shareholder of the Company, and a Hillhouse Capital employee is a member of the Company's board of directors.
−Removed: 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: During the years ended December 31, 2021 and 2020, the Company entered into additional short-term working capital loans with China Industrial Bank and China Merchants Bank to borrow up to RMB 1,940,000 in aggregate, with maturity dates ranging from April 19, 2021 to December 15, 2022.
The Company drew down $ 206,449 (RMB 1,332,197 ) during the year ended December 31, 2021.
+Added: The Company repaid $ 123,122 (RMB 789,918 ) of the short-term loans during the year ended.
+Added: December 31, 2021.
The weighted average interest rate for the short-term working capital loans was approximately 4.2 % as of December 31, 2021.
−Removed: 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.
−Removed: The loan facility was secured with RMB deposited at Industrial Bank.
−Removed: In December 2019, the Company repaid the outstanding principal of $ 24,419 (RMB 170,000 ).
−Removed: 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.
−Removed: 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.
−Removed: 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 .
−Removed: The loan interest rate was 4.4 % as of December 31, 2020.
The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC.
The loan interest rate was 4.3 % as of December 31, 2021.
+Added: The Company drew down $ 16,838 (RMB 107,794 ) during the year ended December 31, 2021 .
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.
−Removed: The Shareholder Loan had a conversion feature, settled in a variable number of shares of common stock upon conversion (the “debt-to-equity conversion”).
−Removed: On April 14, 2017, BeiGene Biologics drew down the entire Shareholder Loan of RMB 900,000 from GET.
−Removed: 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).
−Removed: 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: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Contractual Maturities of Debt Obligations
12 unchanged sentences
Product Revenue
−Removed: The Company’s product revenue is derived from the sale of its internally developed products BRUKINSA ® in the United States and China and tislelizumab in China, as well as the sale of REVLIMID ® , VIDAZA ® and ABRAXANE ® in China under a license from BMS and XGEVA ® in China under a license from Amgen.
−Removed: On March 25, 2020, the Company announced that the
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: 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.
+Added: The Company’s product revenue is primarily derived from the sale of its internally developed products BRUKINSA ® in the United States and China, and tislelizumab and pamiparib in China;
+Added: REVLIMID ® and VIDAZA ® in China under a license from BMS;
+Added: and XGEVA ® and BLINCYTO ® in China under a license from Amgen.
The table below presents the Company’s net product sales for the years ended December 31, 2021, 2020 and 2019.
12 unchanged sentences
— 17,770 111,279
+Added: 45,956 8,496 —
Other 12,754 201 —
Total product revenue - net 633,987 308,874 222,596
−Removed: The following table presents the roll-forward of accrued sales rebates and returns for the years ended December 31, 2020 and December 31, 2019.
−Removed: Sales Rebates and Returns
−Removed: Balance as of December 31, 2018 4,749
−Removed: Accrual 6,164
−Removed: Payment ( 7,715 )
−Removed: Balance as of December 31, 2019 3,198
−Removed: Accrual 15,798
−Removed: Payment ( 7,122 )
−Removed: Balance as of December 31, 2020 11,874
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: The following table presents the roll-forward of accrued sales rebates and returns for the years ended December 31, 2021 and December 31, 2020.
+Added: Year Ended December 31,
+Added: Beginning balance, as of January 1 11,874 3,198
+Added: Accrual 114,837 15,798
+Added: Payment ( 67,072 ) ( 7,122 )
+Added: Ending balance, as of December 31 59,639 11,874
+Added: Sales rebates accrued and paid during the year ended December 31, 2021 increased as a result of compensating distributors for products previously sold at the pre-NRDL price, which remained in the distribution channel, due to the first inclusion of tislelizumab, BRUKINSA ® and XGEVA ® in the NRDL effective March 1, 2021 and additional indications for tislelizumab, BRUKINSA ® and pamiparib effective January 1, 2022.
+Added: The impact of the NRDL price reductions on net revenue totaled $ 57,450 for the year ended December 31, 2021.
+Added: The majority of the accrued compensation related to sales of tislelizumab.
Loss Per Share
2 unchanged sentences
2021 2020 2019
+Added: Net loss ( 1,413,354 ) ( 1,600,523 ) ( 950,578 )
+Added: Net loss attributable to noncontrolling interest — ( 3,617 ) ( 1,950 )
Net loss attributable to BeiGene, Ltd.
11 unchanged sentences
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.
−Removed: On January 1, 2018, 29,603,616 ordinary shares were added to the 2016 Plan under this provision.
+Added: On January 1, 2018, 29,603,616 ordinary shares were added
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: to the 2016 Plan under this provision.
However, in August 2018, in connection with the Hong Kong IPO, the board of directors of the Company approved an amended and restated 2016 Plan to remove this "evergreen" provision and implement other changes required by the Hong Kong Stock Exchange (HKEx) rules.
−Removed: In December 2018, the board of directors approved a second amended and restated 2016 Plan to increase the number of shares authorized for issuance by 38,553,159 ordinary shares, as well as amend the cap on annual compensation to independent directors and make other changes.
+Added: In December 2018, the shareholders of the Company approved a second amended and restated 2016 Plan to increase the number of shares authorized for issuance by 38,553,159 ordinary shares, as well as amend the cap on annual compensation to independent directors and make other changes.
In June 2020, the shareholders approved an Amendment No.
6 unchanged sentences
The terms and conditions of the 2018 Plan, and the forms of award agreements to be used thereunder, are substantially similar to the 2016 Plan and the forms of award agreements thereunder.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: 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: 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.
As of December 31, 2021, share-based awards to acquire 9,344,659 ordinary shares were available for future grant under the 2018 Plan.
3 unchanged sentences
In August 2018, in connection with the Hong Kong IPO, the board of directors of the Company approved an amended and restated ESPP to remove an “evergreen” share replenishment provision originally included in the plan and implement other changes required by the HKEx rules.
−Removed: In December 2018, the board of directors approved a second amended and restated ESPP to increase the number of shares authorized for issuance by 3,855,315 ordinary shares to 7,355,315 ordinary shares.
+Added: In December 2018, the shareholders of the Company approved a second amended and restated ESPP to increase the number of shares authorized for issuance by 3,855,315 ordinary shares to 7,355,315 ordinary shares.
The ESPP allows eligible employees to purchase the Company’s ordinary shares (including in the form of ADSs) at the end of each offering period, which will generally be six months , at a 15 % discount to the market price of the Company’s ADSs at the beginning or the end of each offering period, whichever is lower, using funds deducted from their payroll during the offering period.
Eligible employees are able to authorize payroll deductions of up to 10 % of their eligible earnings, subject to applicable limitations.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The following tables summarizes the shares issued under the ESPP:
6 unchanged sentences
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
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.
4 unchanged sentences
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.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
The following table summarizes the Company’s share option activities under the 2011, 2016 and 2018 Plans:
21 unchanged sentences
This unrecognized compensation will be recognized over an estimated weighted-average amortization period of 2.1 years.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The total fair value of employee share option awards vested during the years ended December 31, 2021, 2020 and 2019 was $ 53,571 , $ 55,127 and $ 58,670 , respectively.
2 unchanged sentences
The model requires the input of highly subjective assumptions including the estimated expected stock price volatility and, the exercise multiple for which employees are likely to exercise share options.
−Removed: For expected volatilities, the trading history and observation period of the Company’s own share price movement has not been long enough to match the life of the share option.
−Removed: Therefore, the Company has made reference to the historical price volatilities of ordinary shares of several comparable companies in the same industry as the Company.
+Added: For expected volatilities, the trading history and observation period of the Company’s own share price is used in conjunction with historical price volatilities of ordinary shares of several comparable companies in the same industry as the Company.
For the exercise multiple, the Company was not able to develop an exercise pattern as reference, thus the exercise multiple is based on management’s estimation, which the Company believes is representative of the future exercise pattern of the options.
14 unchanged sentences
Contractual life 10 years 10 years 10 years
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Restricted shares
9 unchanged sentences
Outstanding at December 31, 2020 — —
−Removed: Vested ( 75,000 ) 2.27
Forfeited — —
1 unchanged sentence
Expected to vest at December 31, 2021 — —
−Removed: The Company had no non-employee restricted share activities during the year ended December 31, 2020.
+Added: The Company had no non-employee restricted share activities during the year ended December 31, 2021 and 2020.
As of December 31, 2021, all compensation cost related to restricted shares was fully recognized.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Restricted share units
18 unchanged sentences
This unrecognized compensation will be recognized over an estimated weighted-average amortization period of 2.6 years.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
The following table summarizes total share-based compensation cost recognized for the years ended December 31, 2021, 2020 and 2019:
4 unchanged sentences
Total 240,712 183,481 134,154
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Accumulated Other Comprehensive Income (Loss)
8 unchanged sentences
Amounts reclassified from accumulated other comprehensive income (loss) (1) — ( 1,492 ) — ( 1,492 )
−Removed: Net-current period other comprehensive loss ( 9,079 ) ( 448 ) — ( 9,527 )
+Added: Net-current period other comprehensive (loss) income 23,475 ( 419 ) ( 8,113 ) 14,943
December 31, 2020 14,184 871 ( 8,113 ) 6,942
6 unchanged sentences
During the years ended December 31, 2021, 2020 and 2019, the Company completed the following equity offerings:
−Removed: 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.
−Removed: In this offering, the Company sold 7,425,750 ADSs representing 96,534,750 ordinary shares.
−Removed: 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 of $ 42,413 , were $ 757,587 .
−Removed: 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.
−Removed: In this offering, the Company sold 65,600,000 ordinary shares.
−Removed: Net proceeds, after deducting underwriting discounts and commissions and offering expenses of $ 32,947 , were $ 869,709 .
−Removed: 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: 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 Share Purchase Agreement executed in connection with the Amgen Collaboration Agreement.
On March 17, 2020, BeiGene, Ltd.
and Amgen entered into an Amendment No.
−Removed: 2 (the “Second Amendment”) to the Share Purchase Agreement in order to account for periodic dilution from the issuance of shares by the
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: Company, which was restated in its entirety on September 24, 2020 (the “Restated Second Amendment”).
−Removed: Pursuant to the Restated Second Amendment, Amgen will have an option (the “Direct Purchase Option”) to subscribe for additional ordinary shares of the Company in the form of ADSs (the “Additional Shares”) in an amount necessary to enable it to increase (and subsequently maintain) its ownership at approximately 20.6 % of the Company's outstanding shares.
+Added: 2 (the “Second Amendment”) to the Share Purchase Agreement in order to account for periodic dilution from the issuance of shares by the Company, which was restated in its entirety on September 24, 2020 (the “Restated Second Amendment”).
+Added: Pursuant to the Restated Second Amendment, Amgen has an option (the “Direct Purchase Option”) to subscribe for additional ordinary shares of the Company in the form of ADSs (the “Additional Shares”) in an amount necessary to enable it to increase (and subsequently maintain) its ownership at approximately 20.6 % of the Company's outstanding shares.
The Direct Purchase Option is exercisable on a monthly basis, but only if Amgen’s interest in the outstanding shares of the Company at the monthly reference date is less than 20.4 %.
10 unchanged sentences
The offering was made without an underwriter or a placement agent, and as a result the Company did not pay any underwriting discounts or commissions in connection with the offering.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: In September 2021, upon Amgen's exercise of its Direct Purchase Option, the Company issued an aggregate of 165,529 ADSs, representing 2,151,877 ordinary shares, to Amgen Inc.
+Added: for a total consideration of $ 50,000 , in a private placement pursuant to a Share Purchase Agreement dated October 31, 2019, as amended on December 6, 2019 and September 24, 2020 by and between Amgen and Company.
+Added: In December 2021, the Company completed an initial public offering of (STAR Offering) on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange (SSE).
+Added: The shares offered in the STAR Offering were issued to and subscribed for by permitted investors in the People’s Republic of China (PRC) in Renminbi (RMB Shares).
+Added: The public offering price of the RMB Shares was RMB 192.60 per ordinary share, or $ 391.68 per ADS.
+Added: In this offering, the Company sold 115,055,260 ordinary shares.
+Added: Net proceeds after deducting underwriting discounts and commission and offering expenses were $ 3,392,616 .
+Added: As required by the PRC securities laws, the net proceeds from the STAR Offering must be used in strict compliance with the planned uses as disclosed in the PRC prospectus as well as the Company's proceeds management policy for the STAR Offering approved by the board of directors.
Restricted Net Assets
6 unchanged sentences
The Company’s PRC subsidiaries were established as domestic invested enterprises and therefore were subject to the above-mentioned restrictions on distributable profits.
−Removed: During the years ended December 31, 2020, 2019 and 2018, no appropriation to statutory reserves was made, because the PRC subsidiaries had substantial losses during such periods.
+Added: During the years ended December 31, 2021, 2020 and 2019, no appropriation to statutory reserves was made, because the PRC subsidiaries had an accumulated deficit as of the end of such periods.
As a result of these PRC laws and regulations, including the requirement to make annual appropriations of at least 10 % of after-tax income and set aside as general reserve fund prior to payment of dividends, the Company’s PRC subsidiaries are restricted in their ability to transfer a portion of their net assets to the Company.
5 unchanged sentences
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
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: contributions made.
+Added: The Company has no legal obligation for the benefits beyond the contributions made.
The total amounts for such employee benefits, which were expensed as incurred, were $ 63,772 , $ 23,717 and $ 23,282 for the years ended December 31, 2021, 2020 and 2019, respectively.
4 unchanged sentences
Company contributions to the 401(k) plan totaled $ 7,483 , $ 4,840 and $ 2,389 in the years ended December 31, 2021, 2020 and 2019, respectively.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The Company maintains a government mandated program to cover its employees in Switzerland for pension, death, or disability.
4 unchanged sentences
Defined Benefit Plan
−Removed: The Company also maintains a defined benefit pension plan covering its employees in Switzerland (the "Swiss Plan").
+Added: The Company maintains a defined benefit pension plan covering its employees in Switzerland (the "Swiss Plan").
This plan is a government mandated fund that provides benefits to employees upon retirement, death, or disability.
Contributions are made based on various percentages of participants' salaries and wages determined based on participants' age and other factors.
−Removed: 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: As of December 31, 2021 and 2020, the projected benefit obligations under the Swiss Plan were approximately $ 34,517 and $ 23,566 , respectively, and plan assets were approximately $ 26,703 and $ 15,453 , respectively.
The funded status of the Swiss Plan is included in other long-term liabilities in the accompanying consolidated balance sheets.
−Removed: 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 initial determination of the pension liability was recorded as other comprehensive loss during the year ended December 31, 2020 and subsequently amortized as a component of net periodic pension cost (see Note 17).
The Company's annual contribution to the Swiss Plan is estimated to be approximately $ 1,604 in 2022 and is expected to evolve thereafter proportionally with changes in staffing and compensation levels, actuarial assumptions and actual investment returns on plan assets.
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, 2021:
−Removed: 2026 - 2030 1,919
Commitments and Contingencies
3 unchanged sentences
Capital commitments
−Removed: 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
+Added: The Company had capital commitments amounting to $ 42,394 for the acquisition of property, plant and equipment as of December 31, 2021, which were mainly for the Company’s biologics manufacturing facility in Guangzhou, China, small molecule manufacturing facility in Suzhou, 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 clinical 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-
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: and development activities in Guangzhou, China, and research and development operations at the Changping facility in Beijing, China.
−Removed: Co-development funding commitment
−Removed: 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 .
−Removed: The Company is funding its portion of the co-development costs by contributing cash and/or development services.
+Added: development costs by contributing cash and/or development services.
As of December 31, 2021, the Company's remaining co-development funding commitment was $ 791,059 .
+Added: Research and Development Commitment
+Added: The Company entered into long-term research and development agreements, which include obligations to make upfront payments and fixed quarterly payments over the next five years .
+Added: As of December 31, 2021, the total research and development commitment amounted to $ 27,985 .
+Added: Funding Commitment
+Added: The Company had committed capital related to an equity method investment in the amount of $ 15,000 .
+Added: As of December 31, 2021, the remaining capital commitment was $ 12,750 and is expected to be paid from time to time over the investment period.
Other Business Agreements
The Company enters into agreements in the ordinary course of business with contract research organizations (CROs) to provide research and development services.
−Removed: These contracts are generally cancelable at any time by the Company with prior written notice.
+Added: These contracts are generally cancellable at any time by the Company with prior written notice.
The Company also enters into collaboration agreements with institutions and companies to license intellectual property.
3 unchanged sentences
When the achievement of these milestones or sales have occurred, the corresponding amounts are recognized in the consolidated financial statements.
−Removed: Selected Quarterly Financial Data (Unaudited)
−Removed: The following table summarizes the unaudited statements of operations for each quarter of 2020 and 2019 (in thousands, except share and per share amounts).
−Removed: The unaudited quarterly information has been prepared on a basis consistent with the audited financial statements and includes all adjustments that the Company considers necessary for a fair presentation of the information shown.
−Removed: The operating results for any fiscal quarter are not necessarily indicative of the operating results for a full fiscal year or for any future period and there can be no assurances that any trend reflected in such results will continue in the future.
−Removed: Quarter Ended
−Removed: March 31, June 30, September 30, December 31,
−Removed: Revenue 52,059 65,635 91,080 100,100
−Removed: Loss from operations ( 373,756 ) ( 358,877 ) ( 440,137 ) ( 484,912 )
−Removed: Net loss ( 364,939 ) ( 336,318 ) ( 426,617 ) ( 472,649 )
−Removed: Net loss attributable to ordinary shareholders ( 363,735 ) ( 335,202 ) ( 425,224 ) ( 472,745 )
−Removed: Basic and diluted net loss per share (1)
−Removed: ( 0.36 ) ( 0.33 ) ( 0.37 ) ( 0.40 )
−Removed: Quarter Ended
−Removed: March 31, June 30, September 30, December 31,
−Removed: Revenue 77,833 243,346 50,141 56,892
−Removed: Loss from operations ( 173,755 ) ( 85,833 ) ( 312,266 ) ( 388,037 )
−Removed: Net loss ( 168,069 ) ( 85,954 ) ( 308,660 ) ( 387,895 )
−Removed: Net loss attributable to ordinary shareholders ( 167,640 ) ( 85,570 ) ( 307,357 ) ( 388,061 )
−Removed: Basic and diluted net loss per share (1)
−Removed: ( 0.22 ) ( 0.11 ) ( 0.39 ) ( 0.49 )
−Removed: (1) Per ordinary 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 ordinary shares outstanding during each period, principally due to the effect of share issuances by the Company during the year.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2020, 2019 AND 2018
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Segment and Geographic Information
2 unchanged sentences
Its chief operating decision maker is the Chief Executive Officer, who makes operating decisions, assesses performance, and allocates resources on a consolidated basis.
−Removed: The Company’s long-lived assets are substantially located in the PRC.
+Added: The Company’s long-lived assets are substantially located in the PRC, with the exception of land which is in the U.S.
Net product revenues by geographic area are based upon the location of the customer, and net collaboration revenue is recorded in the jurisdiction in which the related income is expected to be sourced from.
4 unchanged sentences
495,265 18,228 134,689
−Removed: Other — 71,966 23,042
+Added: ROW 163,845 — 71,966
Total 1,176,283 308,874 428,212
−Removed: Subsequent Events
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Closing of the transaction is subject to the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
−Removed: 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”).
−Removed: 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”).
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: PRC revenues for each of the three years in the period ended December 31, 2021 consisted entirely of product sales.
+Added: revenues for the year ended December 31, 2021 consisted of collaboration revenues of $ 379,607 and BRUKINSA ® product sales of $ 115,658 , respectively.
+Added: revenues for the year ended December 31, 2020 consisted entirely of BRUKINSA ® product sales.
+Added: revenues for the year ended December 31, 2019 consisted primarily of collaboration revenues.
+Added: Rest of world revenues for each of the three years in the period ended December 31, 2021 consisted primarily of collaboration revenues.
Exhibit Index
2 unchanged sentences
Herein from Form or Schedule Filing Date SEC File/
−Removed: 3.1 Fifth Amended and Restated Memorandum and Articles of Association of the Registrant, as currently in effect
+Added: 3.1 Sixth Amended and Restated Memorandum and Articles of Association of the Registrant, as currently in effect
(Exhibit 3.1) 12/17/2021 001-37686
24 unchanged sentences
4.6 Description of BeiGene, Ltd.'s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934
−Removed: Lease Agreements
−Removed: 10.1 Lease Agreement, dated as of April 10, 2016, between BeiGene (Suzhou) Co., Ltd.
−Removed: and Suzhou Industrial Park Biotech Development Co., Ltd.
−Removed: (English Translation)
+Added: Collaboration, License and Commercial Agreements
+Added: 10.1# .1# License and Supply Agreement, dated July 5, 2017, by and between the Registrant and Celgene Logistics Sàrl
(Exhibit 10.3) 11/13/2017 001-37686
2 unchanged sentences
Herein from Form or Schedule Filing Date SEC File/
−Removed: Collaboration, License and Commercial Agreements
−Removed: 10.2# .1 License and Supply Agreement, dated July 5, 2017, by and between the Registrant and Celgene Logistics Sàrl
−Removed: (Exhibit 10.3) 11/13/2017 001-37686
.2# Assignment and Assumption Agreement, dated December 29, 2017, by and between the Registrant and BeiGene Switzerland GmbH
10 unchanged sentences
(Exhibit 10.10) 3/2/2020 001-37686
−Removed: Exhibit Description Filed/ Furnished
−Removed: Herewith Incorporated by Reference
−Removed: Herein from Form or Schedule Filing Date SEC File/
.3## Restated Amendment No.
3 unchanged sentences
(Exhibit 10.11) 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/
10.6 Guarantee, dated October 31, 2019, by and between the Registrant and Amgen Inc.
(Exhibit 10.12) 3/2/2020 001-37686
−Removed: 10.8 Form of Share Purchase Agreement dated July 12, 2020 by and among the Registrant and Purchasers named therein
+Added: 10.7## .1## Collaboration and License Agreement, dated January 11, 2021, by and between BeiGene Switzerland GmbH and Novartis Pharma AG
(Exhibit 10.1) 5/6/2021 001-37686
+Added: .2## Option, Collaboration and License Agreement, dated December 19, 2021, by and between BeiGene Switzerland GmbH and Novartis Pharma AG
Equity and Other Compensation Plans
6 unchanged sentences
(Exhibit 10.1) 6/17/2020 001-37686
−Removed: .3† Forms of Restricted Share Unit Award Agreement for Non-Employee Directors under the 2016 Share Option and Incentive Plan
+Added: .3† Form of Global Restricted Share Unit Award Agreement for Non-Employee Directors under the Second Amended and Restated 2016 Share Option and Incentive Plan
(Exhibit 10.2) 8/5/2021 001-37686
15 unchanged sentences
(Exhibit 10.5) 8/9/2018 001-37686
−Removed: 10.12† .1† Second Amended and Restated 2018 Employee Share Purchase Plan
+Added: 10.11† .1† Third Amended and Restated 2018 Employee Share Purchase Plan
(Exhibit 10.7) 8/5/2021 001-37686
+Added: 10.12† Senior Executive Cash Incentive Bonus Plan
+Added: (Exhibit 10.19) 1/19/2016 333-207459
Exhibit Description Filed/ Furnished
1 unchanged sentence
Herein from Form or Schedule Filing Date SEC File/
−Removed: .2† Amendment No.
−Removed: 1 to the Second Amended and Restated 2018 Employee Share Purchase Plan
−Removed: (Exhibit 10.2) 6/5/2019 001-37686
−Removed: 10.13† Senior Executive Cash Incentive Bonus Plan
−Removed: (Exhibit 10.19) 1/19/2016 333-207459
10.13† Independent Director Compensation Policy, as amended
11 unchanged sentences
(Exhibit 10.2) 5/11/2020 001-37686
−Removed: 10.18† Employment Agreement, dated July 13, 2015, by and between BeiGene USA, Inc.
−Removed: and Howard Liang
+Added: 10.17† Offer letter, dated May 29, 2020, by and between the Registrant and Julia Wang
(Exhibit 10.9) 8/5/2021 001-37686
3 unchanged sentences
10.19† Consulting Agreement, dated February 24, 2021, by and between the Registrant and Xiaodong Wang
+Added: (Exhibit 10.20) 2/25/2021 001-37686
+Added: 10.20† Employment Agreement, dated December 30, 2021, by and between BeiGene (Shanghai) Co., Ltd.
+Added: 21.1 List of Subsidiaries of the Registrant
Exhibit Description Filed/ Furnished
1 unchanged sentence
Herein from Form or Schedule Filing Date SEC File/
−Removed: 21.1 List of Subsidiaries of the Registrant
23.1 Consent of Ernst & Young Hua Ming LLP
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: 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
+Added: 31.2 Certification of Principal 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.
21 unchanged sentences
Each person whose individual signature appears below hereby authorizes and appoints John V.
−Removed: Oyler, Howard Liang, and Scott A.
+Added: Oyler, Julia Wang, and Scott A.
Samuels, and each of them, with full power of substitution and resubstitution and full power to act without the other, as his or her true and lawful attorney‑in‑fact and agent to act in his or her name, place and stead and to execute in the name and on behalf of each person, individually and in each capacity stated below, and to file any and all amendments to this Annual Report on Form 10‑K and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys‑in‑fact and agents, and each of them, full power and authority to do and perform each and every act and thing, ratifying and confirming all that said attorneys‑in‑fact and agents or any of them or their or his substitute or substitutes may lawfully do or cause to be done by virtue thereof.
3 unchanged sentences
Oyler (Principal Executive Officer)
−Removed: /s/ HOWARD LIANG Chief Financial Officer and Chief Strategy Officer February 25, 2021
−Removed: Howard Liang (Principal Financial and Accounting Officer)
+Added: /s/ JULIA WANG Chief Financial Officer February 28, 2022
+Added: Julia Wang (Principal Financial and Accounting Officer)
/s/ TIMOTHY CHEN Director February 28, 2022
1 unchanged sentence
GLAZER Director February 28, 2022
+Added: /s/ MARGARET DUGAN Director February 28, 2022
+Added: Margaret Dugan
/s/ MICHAEL GOLLER Director February 28, 2022
8 unchanged sentences
Xiaodong Wang
+Added: /s/ ALESSANDRO RIVA Director February 28, 2022
+Added: Alessandro Riva
/s/ CORAZON (CORSEE) D.
1 unchanged sentence
Corazon (Corsee) D.
−Removed: /s/ JING-SHYH (SAM) SU Director February 25, 2021
−Removed: Jing-Shyh (Sam) Su
/s/ QINGQING YI Director February 28, 2022
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.