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
−Removed: 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.
−Removed: 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.
+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 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: 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
+Added: control objectives, and management necessarily was required to apply its judgment in designing and evaluating the controls and procedures.
Management’s Annual Report on Internal Control Over Financial Reporting
6 unchanged sentences
Based on our assessment and those criteria, management concluded that we maintained effective internal control over financial reporting as of December 31, 2022.
−Removed: The effectiveness of our internal control over financial reporting as of December 31, 2021, has been tested by Ernst & Young Hua Ming LLP, our independent registered public accounting firm, as stated in their report which is included in “Item 8—Financial Statements and Other Supplementary Data” in this Annual Report.
+Added: The effectiveness of our internal control over financial reporting as of December 31, 2022, has been tested by Ernst & Young LLP, our independent registered public accounting firm, as stated in their report which is included in “Item 8—Financial Statements and Other Supplementary Data” in this Annual Report.
Changes in Internal Control over Financial Reporting
1 unchanged sentence
Other Information
+Added: On October 31, 2019, our wholly-owned subsidiary, BeiGene Switzerland GmbH (“BeiGene Switzerland”), entered into a collaboration agreement with Amgen Inc.
+Added: (“Amgen”), which became effective on January 2, 2020 (as amended, the "Collaboration Agreement").
+Added: Pursuant to the Collaboration Agreement, we agreed to collaborate on the commercialization of Amgen’s oncology products XGEVA ® , BLINCYTO ® and KYPROLIS ® in China, and the global development and commercialization in China of a portfolio of Amgen's clinical- and late-preclinical-stage pipeline products.
+Added: In connection with our ongoing assessment of the Collaboration Agreement cost-share contributions, we determined that our further investment in the development of LUMAKRAS ® also known as sotorasib (“AMG 510”) was no longer commercially viable for BeiGene.
+Added: As a result, on February 26, 2023, we entered into an amendment to the Collaboration Agreement to (i) stop sharing costs with Amgen for the further development of AMG 510 during the period starting January 1, 2023 and ending August 31, 2023;
+Added: and (ii) cooperate in good faith to prepare a transition plan with the anticipated termination of AMG 510 from the Collaboration Agreement.
+Added: The foregoing description of the terms of the amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the agreement, which the Company intends to file as an exhibit to a subsequent periodic report.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
−Removed: Not applicable.
+Added: On March 30, 2022, the SEC added us to its conclusive list of issuers identified under the HFCAA following the filing of our annual report on Form 10-K with the SEC on February 28, 2022, which annual report was audited by Ernst & Young Hua Ming LLP, a registered public accounting firm in mainland China that the PCAOB previously was unable to inspect or investigate completely, because of a position taken by an authority in the foreign jurisdiction.
+Added: However, as our global business has expanded, we have evaluated, designed and implemented business processes and control changes and built substantial organizational capabilities outside of China.
+Added: Therefore, on March 23, 2022, following a review process carried out by our audit committee, Ernst & Young Hua Ming LLP resigned as our independent registered public accounting firm for the audit of our financial statements and internal control over financial reporting to be filed with the SEC.
+Added: On the same day, our audit committee approved the engagement of Ernst & Young LLP, located in Boston, Massachusetts, United States, as the Company’s independent registered public accounting firm for the audit of our financial statements and internal control over financial reporting for the fiscal year ending December 31, 2022.
+Added: Given that Ernst & Young LLP (United States) now serves as the principal accountant to audit our consolidated financial statements, we expect to be able to comply with the HFCAA and AHFCAA and certify that we have retained a registered public accounting firm that the PCAOB has determined it is able to inspect or investigate which would preclude a further finding by the SEC that we are a Commission-Identified Issuer.
+Added: Furthermore, in August 2022, the PCAOB signed a Statement of Protocol with the CSRC and the Ministry of Finance of the People's Republic of China, taking the first step toward opening access for the PCAOB to inspect and investigate registered public accounting firms headquartered in mainland China and Hong Kong.
+Added: PCAOB staff members conducted on-site inspections and investigations from September to November 2022, and in December 2022, the PCAOB announced that it has secured complete access to inspect and investigate registered public accounting firms headquartered in mainland China and Hong Kong and confirmed that until such time as the PCAOB issues any new determination, there are no Commission-Identified Issuers at risk of having their securities subject to a trading prohibition under the HFCAA.
+Added: To the extent known by the Company, the Company is not aware of and has no reason to believe that:
+Added: any governmental entity in the foreign jurisdiction in which the Company is incorporated or otherwise organized owns shares of any capital stock of record of the Company;
+Added: any official of the Chinese government or Hong Kong SAR is a board member or officer of the Company or its operating subsidiaries;
+Added: or that the Company’s articles of incorporation, as amended, contain any provisions known by the Company to include any charter or charter provisions of the Chinese Communist Party.
+Added: The Company has determined that no governmental entity in mainland China or Hong Kong, directly or indirectly, possesses the power to direct or cause the direction of the management and policies of the Company or has a controlling financial interest.
+Added: The Company has made this determination based on the fact that as of the date of this annual report, no such governmental entity has filed a Schedule 13D or 13G, there are no material contracts with such a foreign governmental party, and there is no such foreign government representative on the Company’s Board.
Directors, Executive Officers and Corporate Governance
11 unchanged sentences
Principal Accounting Fees and Services
−Removed: Our independent public accounting firm is Ernst & Young Hua Ming LLP (PCAOB ID:
+Added: Our independent public accounting firm is Ernst & Young LLP (PCAOB ID:
+Added: 00 42 ), located in Boston, Massachusetts, United States.
+Added: Our independent public accounting firm for the years ended December 31, 2021 and 2020 was Ernst & Young Hua Ming LLP (PCAOB ID:
1408), located in Beijing, People's Republic of China.
20 unchanged sentences
Opinion on the Financial Statements
−Removed: We have audited the accompanying consolidated balance sheets of BeiGene, Ltd.
−Removed: (the Company) as of December 31, 2021 and 2020, the related consolidated statements of operations, comprehensive loss, cash flows and shareholders' equity for each of the three years in the period ended December 31, 2021, and the related notes (collectively referred to as the "consolidated financial statements").
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2021, in conformity with U.S.
+Added: We have audited the accompanying consolidated balance sheet of BeiGene, Ltd.
+Added: and subsidiaries (the Company) as of December 31, 2022, the related consolidated statements of operations, comprehensive loss, shareholders' equity and cash flows for the year ended December 31, 2022, and the related notes (collectively referred to as the “consolidated financial statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2022, and the results of its operations and its cash flows for the year ended December 31, 2022, in conformity with U.S.
generally accepted accounting principles.
2 unchanged sentences
These financial statements are the responsibility of the Company's management.
−Removed: Our responsibility is to express an opinion on the Company's financial statements based on our audits.
+Added: Our responsibility is to express an opinion on the Company’s financial statements based on our audit.
We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.
federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audit in accordance with the standards of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
+Added: Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
+Added: Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
+Added: We believe that our audit provides a reasonable basis for our opinion.
+Added: Critical Audit Matters
+Added: The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that:
+Added: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.
+Added: The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: Accrued Clinical Trial Expenses
+Added: Description of the Matter As of December 31, 2022, the Company recorded $138 million of accrued external research and development expenses.
+Added: As discussed in Note 2 to the consolidated financial statements, accrued external research and development expenses consist of various costs including clinical and pre-clinical trials, cost to develop product candidates, research services and other research and development related costs.
+Added: Expenses related to clinical trials are accrued based on estimates of the actual services performed by third parties for the respective period.
+Added: As the majority of clinical service providers invoice the Company in arrears for services performed, the Company determines estimates based on reviewing open contracts and purchase orders, assessing services that have been performed on its behalf, and estimating the level of service performed and the associated costs incurred for the services.
+Added: Auditing the Company’s accrued external clinical trial expenses is especially challenging as the determination of clinical trial activities requires judgment and estimates resulting from delays in reporting from vendors.
+Added: While the Company’s estimates of accrued clinical trial expenses are primarily based on information received related to each study from its vendors, the Company may need to make an estimate for additional costs incurred.
+Added: These estimates are based on several factors, including management’s knowledge of the clinical trial timelines associated with activities, invoicing to date and the provisions in the contracts.
+Added: Additionally, due to the long duration of clinical trials and the timing of invoicing received from vendors, the actual amounts incurred are not typically known at the time the financial statements are issued.
+Added: How We Addressed the Matter in Our Audit We evaluated and tested the design and operating effectiveness of internal controls over the Company’s process used in determining the valuation and completeness of accrued clinical trial expenses.
+Added: This included testing controls over management’s review of the significant assumptions and other inputs used in the estimation of accrued external clinical trial expenses, including contractual terms, estimated expenses incurred, and total invoicing to date.
+Added: To test the accrued clinical trial expenses, our audit procedures included, among others, testing the accuracy and completeness of the underlying data used in determining the accrued clinical trial expenses and evaluating the assumptions and estimates used by management.
+Added: To evaluate the completeness and valuation of the accrual, we corroborated the progress of clinical trials with the Company’s research and development personnel that oversee the clinical trials and obtained actual cost information directly from vendors.
+Added: We also tested subsequent invoices received and evaluated contractual arrangements with vendors, including any pending change orders to assess the impact to the accrual.
+Added: /s/ Ernst & Young LLP
+Added: We have served as the Company’s auditor since 2022
+Added: Boston, Massachusetts
+Added: February 27, 2023
+Added: Report of Independent Registered Public Accounting Firm
+Added: To the Shareholders and the Board of Directors of BeiGene, Ltd.
+Added: Opinion on the Financial Statements
+Added: We have audited the accompanying consolidated balance sheet of BeiGene, Ltd.
+Added: (the Company) as of December 31, 2021, the related consolidated statements of operations, comprehensive loss, cash flows and shareholders' equity for each of the two years in the period ended December 31, 2021, and the related notes (collectively referred to as the "consolidated financial statements").
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2021, in conformity with U.S.
+Added: generally accepted accounting principles.
+Added: Basis for Opinion
+Added: These financial statements are the responsibility of the Company's management.
+Added: Our responsibility is to express an opinion on the Company's financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.
+Added: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB.
4 unchanged sentences
We believe that our audits provide a reasonable basis for our opinion.
−Removed: Critical Audit Matters
−Removed: The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
−Removed: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
−Removed: Accrual of research and development expenses
−Removed: Description of the Matter During the year ended December 31, 2021, the Company recognized $1,459.2 million in research and development (“R&D”) expenses.
−Removed: The balance of accrued external R&D activities related expenses as of December 31, 2021 amounted to approximately $213.9 million.
−Removed: As described in Note 2 to the consolidated financial statements, R&D expenses include costs related to clinical trials paid to third-party contract research organizations and contract manufacturing organizations (collectively referred as “Outsourced Service Providers”).
−Removed: Auditing the accrual of R&D expenses related to Outsourced Service Providers is complex because the clinical trial activities with the Outsourced Service Providers are typically performed over an extended period with several milestones for the services in each agreement.
−Removed: As a result, R&D expenses are allocated to each financial reporting period based upon the progress of the clinical trial activities.
−Removed: Determining the progress of the clinical trial activities requires significant estimates and judgment.
−Removed: These estimates are based on several factors, including management’s knowledge of the clinical trial activities associated with timelines, invoicing to date and the provisions in the contracts.
−Removed: Changes in these estimates can have a material effect on the amount of R&D expenses recognized during the reporting period.
−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 accrual of the R&D expenses.
−Removed: For example, we tested controls over management's review of the R&D accrual method and the estimates of the actual services performed by the Outsourced Service Providers.
−Removed: To test the accrual of R&D expenses, our audit procedures included, among others, reading the contracts with Outsourced Service Providers on a sample basis and understanding and testing the estimates on the progress of clinical trial activities developed by management.
−Removed: Testing management’s estimates involved evaluating management’s assumptions used in the calculation related to the clinical trial activities and associated timelines, invoicing to date and the provisions in the contracts.
−Removed: We then evaluated the accrual of R&D expenses by comparing it to the subsequent progress billings issued by the Outsourced Service Providers.
−Removed: We also assessed the accrual methodology used by the Company, including the adequacy of related disclosures in the consolidated financial statements.
−Removed: Allocation of transaction price in relation to the Novartis Tislelizumab Agreement
−Removed: 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.
−Removed: 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:
−Removed: 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”);
−Removed: and 2) conducting and completing ongoing trials of tislelizumab (“R&D services obligation”).
−Removed: The transaction price of $650.0 million was allocated to each performance obligation based on their relative standalone selling prices.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The transaction price allocated to the R&D services obligation was deferred and recognized over time using a percentage-of-completion method.
−Removed: 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.
−Removed: 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.
−Removed: 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 the transaction price in relation to the Novartis Tislelizumab Agreement.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: We compared these significant assumptions to industry, business and market data and information available from third-party sources.
−Removed: 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.
−Removed: In addition, we assessed the adequacy of the related disclosures in the consolidated financial statements.
/s/ Ernst & Young Hua Ming LLP
−Removed: We have served as the Company’s auditor since 2014
+Added: We served as the Company’s auditor from 2014 to 2022.
Beijing, People’s Republic of China
February 28, 2022,
+Added: except for the effects on the consolidated financial statements of the correction of an error as described in Notes 2 and 3, as to which the date is
+Added: February 27, 2023
Report of Independent Registered Public Accounting Firm
4 unchanged sentences
(the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2022, based on the COSO criteria.
−Removed: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2021 and 2020, the related consolidated statements of operations, comprehensive loss, cash flows and shareholders' equity for each of the three years in the period ended December 31, 2021, and the related notes and our report dated February 28, 2022 expressed an unqualified opinion thereon.
+Added: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheet of the Company as of December 31, 2022, the related consolidated statement of operations, comprehensive loss, shareholders' equity and cash flows for the year ended December 31, 2022, and the related notes and our report dated February 27, 2023 expressed an unqualified opinion thereon.
Basis for Opinion
−Removed: The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting.
+Added: The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control over Financial Reporting.
Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.
12 unchanged sentences
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
−Removed: /s/ Ernst & Young Hua Ming LLP
−Removed: Beijing, People’s Republic of China
+Added: /s/ Ernst & Young LLP
+Added: Boston, Massachusetts
February 27, 2023
17 unchanged sentences
Intangible assets, net 11 40,616 46,679
−Removed: Deferred tax assets 11 110,424 65,962
Other non-current assets 13 170,413 163,049
25 unchanged sentences
Additional paid-in capital 11,540,979 11,191,007
−Removed: Accumulated other comprehensive income 17 17,950 6,942
+Added: Accumulated other comprehensive (loss) income 18 ( 77,417 ) 17,950
Accumulated deficit ( 7,080,342 ) ( 5,076,527 )
17 unchanged sentences
Loss from operations ( 1,789,665 ) ( 1,438,735 ) ( 1,657,682 )
−Removed: Interest (expense) income, net ( 15,757 ) 1,998 9,131
−Removed: Other income, net 5 15,904 37,490 7,174
+Added: Interest income (expense), net 52,480 ( 15,757 ) 1,998
+Added: Other (expense) income, net 6 ( 223,852 ) 15,904 37,490
Loss before income taxes ( 1,961,037 ) ( 1,438,588 ) ( 1,618,194 )
−Removed: Income tax (benefit) expense 11 ( 25,234 ) ( 17,671 ) 6,992
+Added: Income tax expense 12 42,778 19,228 10,397
Net loss ( 2,003,815 ) ( 1,457,816 ) ( 1,628,591 )
14 unchanged sentences
Net loss ( 2,003,815 ) ( 1,457,816 ) ( 1,628,591 )
−Removed: Other comprehensive income (loss), net of tax of nil:
+Added: Other comprehensive (loss) income, net of tax of nil:
Foreign currency translation adjustments 18 ( 90,421 ) 13,714 23,603
19 unchanged sentences
Amortization of research and development cost share liability 4 ( 96,402 ) ( 112,486 ) ( 113,986 )
−Removed: Unrealized gains on equity investments 5 ( 7,632 ) ( 11,826 ) —
−Removed: Deferred income tax benefits ( 41,085 ) ( 27,807 ) ( 9,232 )
+Added: Unrealized losses (gains) on equity investments 6 21,996 ( 7,632 ) ( 11,826 )
+Added: Deferred income tax expense 2,059 3,377 261
Other items, net 9,047 23,510 ( 4,673 )
26 unchanged sentences
Repayment of short-term loans 14 ( 417,081 ) ( 321,754 ) ( 12,247 )
−Removed: Capital contribution from noncontrolling interest — — 4,000
Proceeds from option exercises and employee share purchase plan 46,964 92,762 93,101
−Removed: Net cash provided by financing activities 3,636,911 5,202,826 85,680
+Added: Net cash (used in) provided by financing activities ( 18,971 ) 3,636,911 5,202,826
Effect of foreign exchange rate changes, net ( 69,383 ) 14,035 18,231
−Removed: Net increase (decrease) in cash, cash equivalents, and restricted cash 2,992,882 769,230 ( 119,938 )
+Added: Net (decrease) increase in cash, cash equivalents, and restricted cash ( 507,850 ) 2,992,882 769,230
Cash, cash equivalents, and restricted cash, beginning of year 4,382,887 1,390,005 620,775
7 unchanged sentences
Supplemental non-cash activities:
−Removed: Acquisitions of equipment included in accounts payable 53,197 42,762 29,086
+Added: Accruals for capital expenditures 95,346 53,197 42,762
Purchase of in-process research and development included in accounts payable — 75,000 —
13 unchanged sentences
Balance at December 31, 2019 801,340,698 79 2,925,970 ( 8,001 ) ( 1,993,737 ) 924,311 16,150 940,461
−Removed: Contributions from shareholders — — — — — — 4,000 4,000
−Removed: Exercise of options, ESPP and release of RSUs 20,571,675 2 47,002 — — 47,004 — 47,004
−Removed: Issuance of shares reserved for share option exercises 4,505,839 — — — — — — —
−Removed: Share-based compensation — — 134,154 — — 134,154 — 134,154
−Removed: Other comprehensive loss — — — ( 9,527 ) — ( 9,527 ) ( 345 ) ( 9,872 )
−Removed: Net loss — — — — ( 948,628 ) ( 948,628 ) ( 1,950 ) ( 950,578 )
−Removed: Balance at December 31, 2019 801,340,698 79 2,925,970 ( 8,001 ) ( 1,955,843 ) 962,205 16,150 978,355
Proceeds from issuance of ordinary shares, net of cost 145,838,979 14 2,069,596 — — 2,069,610 — 2,069,610
16 unchanged sentences
Balance at December 31, 2021 1,334,804,281 133 11,191,007 17,950 ( 5,076,527 ) 6,132,563 — 6,132,563
+Added: Cost from issuance of ordinary shares — — ( 152 ) — — ( 152 ) — ( 152 )
+Added: Use of shares reserved for share option exercises 1,375,621 — — — — — — —
+Added: Exercise of options, ESPP and release of RSUs 19,960,278 2 46,962 — — 46,964 — 46,964
+Added: Share-based compensation — — 303,162 — — 303,162 — 303,162
+Added: Other comprehensive loss — — — ( 95,367 ) — ( 95,367 ) — ( 95,367 )
+Added: Net loss — — — — ( 2,003,815 ) ( 2,003,815 ) — ( 2,003,815 )
+Added: Balance at December 31, 2022 1,356,140,180 135 11,540,979 ( 77,417 ) ( 7,080,342 ) 4,383,355 — 4,383,355
The accompanying notes are an integral part of these consolidated financial statements.
6 unchanged sentences
BeiGene, Ltd.
−Removed: (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 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.
−Removed: 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: (the "Company", "BeiGene", "it", "its") is a global biotechnology company that is developing and commercializing innovative affordable oncology medicines to improve treatment outcomes and access for patients worldwide.
+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;
+Added: tislelizumab, an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers;
+Added: 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 ("UK"), Canada, Australia and additional international markets, and tislelizumab and pamiparib in China.
By leveraging its China commercial capabilities, the Company has in-licensed the rights to distribute 13 approved medicines for the China market.
−Removed: 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: Supported by its global clinical development and commercial capabilities, the Company has entered into collaborations with world-leading biopharmaceutical companies such as Amgen Inc.
+Added: ("Amgen") and Novartis Pharma AG ("Novartis") to develop and commercialize innovative medicines.
The Company is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe.
−Removed: 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.
−Removed: This includes more than 30 pivotal or potentially registration-enabling trials across its portfolio, including its three internally discovered, approved medicines.
+Added: Its internal clinical development capabilities are deep, including a more than 2,700 -person global clinical development and medical affairs team that is running close to 80 ongoing or planned clinical trials in over 50 medicines and drug candidates.
+Added: This includes more than 30 pivotal or potentially registration-enabling trials across its portfolio, including three internally discovered, approved medicines.
The Company has enrolled in its clinical trials more than 18,000 subjects, of which approximately one-half have been outside of China.
−Removed: 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 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 is building a commercial-stage biologics manufacturing and clinical R&D center in New Jersey.
The Company also works with high quality contract manufacturing organizations ("CMOs") to manufacture its internally developed clinical and commercial products.
14 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
+Added: Areas where management uses subjective judgment include, but are not limited to, estimating the useful lives of long-lived assets, estimating variable consideration in product sales and collaboration revenue arrangements, identifying separate accounting units and the
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: 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.
+Added: 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, 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.
13 unchanged sentences
Foreign currency denominated financial assets and liabilities are remeasured at the exchange rates prevailing at the balance sheet date.
−Removed: Exchange gains and losses are included in the consolidated statements of comprehensive loss.
+Added: Remeasurement exchange gains and losses are included in the consolidated statements of operations.
Cash, Cash Equivalents and Restricted Cash
6 unchanged sentences
The Company classifies restricted cash as current or non-current based on the term of the restriction.
+Added: In addition to the restricted cash balances above, the Company is required by the PRC securities law to use the proceeds from the STAR offering in strict compliance with the planned uses as disclosed in the PRC prospectus as well as those disclosed in the Company's proceeds management policy approved by the board of directors.
Accounts Receivable and Allowance for Credit Losses
16 unchanged sentences
If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded in the consolidated statements of operations.
−Removed: The Company's investments consist of available-for-sale debt securities, public equity securities with readily determinable fair values, private equity securities without readily determinable fair values, and equity-method investments.
+Added: The Company's investments consist of available-for-sale debt securities, convertible note instruments, public equity securities with readily determinable fair values, private equity securities without readily determinable fair values, and equity-method investments.
The classification of an investment is determined based on the nature of the investment, the Company's ability and intent to hold the investment, and the degree to which the Company may exercise influence over the investee.
5 unchanged sentences
Available-for-sale debt securities with maturities beyond one year may be classified as short-term marketable securities due to their highly liquid nature and because they represent the Company’s investments that are available for current operations.
+Added: • Convertible note instruments are recorded using the fair value option method of accounting.
+Added: Accordingly, convertible note instruments are remeasured at fair value on a recurring basis, with any changes in the fair value option recorded in other (expense) income, net.
• Public equity securities with readily determinable fair values are recorded at fair value.
−Removed: Subsequent changes in fair value are recorded in other income, net.
+Added: Subsequent changes in fair value are recorded in other (expense) income, net.
Derivative financial instruments to purchase public equity securities are recorded at fair value.
The estimated fair value of derivative financial instruments is determined based on the Black-Scholes valuation model.
−Removed: Changes in fair value of derivative instruments are recorded in other income, net.
+Added: Changes in fair value of derivative instruments are recorded in other (expense) income, net.
• Private equity securities without readily determinable fair values and where the Company does not have significant influence are measured at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.
−Removed: Adjustments to private equity securities are recorded in other income, net.
+Added: Adjustments to private equity securities are recorded in other (expense) income, net.
• Equity investments in common stock or in-substance common stock where the Company has significant influence over the financial and operating policies of the investee are accounted for as equity-method investments.
Equity-method investments are initially recorded at cost and subsequently adjusted based on the Company's percentage ownership in the investee's income and expenses, as well as dividends, if any.
−Removed: The Company records its share of the investee's results of operations in other income, net.
+Added: The Company records its share of the investee's results of operations in other (expense) income, net.
The Company records impairment losses on our equity method investments if it deems the impairment to be other-than-temporary.
18 unchanged sentences
Leasehold Improvements Lesser of useful life or lease term
−Removed: Effective January 1, 2019, the Company adopted ASC, Topic 842, Leases (ASC 842) using the effective date method.
+Added: The Company applies ASC, Topic 842, Leases (ASC 842) to account for its leases.
The Company determines if an arrangement is a lease at inception.
35 unchanged sentences
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.
−Removed: The land use right is being amortized over the term of the land use right, which is 30 years.
+Added: In 2022, the Company acquired a second Suzhou land use right from the local Bureau of Land and Resources.
+Added: The land use rights are being amortized over the respective terms of the land use rights, which are each 30 years.
Goodwill and Other Intangible Assets
52 unchanged sentences
Cash equivalents:
−Removed: treasury securities 107,855 — —
Money market funds 758,114 — —
3 unchanged sentences
Equity securities with readily determinable fair values 3,307 706 —
+Added: Convertible debt instrument — — 3,000
+Added: Prepaid expenses and other current assets (Note 6):
+Added: Convertible debt instrument — — 5,190
Total 1,426,672 706 8,190
14 unchanged sentences
Other non-current assets (Note 6):
−Removed: Equity securities 10,810 6,669 —
+Added: Equity securities with readily determinable fair values 23,809 10,306 —
Total 2,689,190 10,306 —
7 unchanged sentences
Refer to Note 6, Investments for details of the determination of the carrying amount of private equity investments without readily determinable fair values and equity method investments.
+Added: The Company holds convertible notes issued by two private biotech companies.
+Added: The Company has elected the fair value option method of accounting for the convertible notes.
+Added: Accordingly, the convertible notes are remeasured at fair value on a recurring basis using Level 3 inputs.
As of December 31, 2022 and 2021, 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.
1 unchanged sentence
Revenue Recognition
−Removed: Effective January 1, 2018, the Company adopted ASC, Topic 606, Revenue from Contracts with Customers (ASC 606) using the modified retrospective method.
+Added: The Company applies ASC, Topic 606, Revenue from Contracts with Customers (ASC 606) to account for its revenue transactions.
Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services.
7 unchanged sentences
Once a contract is determined to be within the scope of ASC 606 at contract inception, the Company reviews the contract to determine which performance obligations it must deliver and which of these performance obligations are distinct.
−Removed: The Company recognizes as revenue the amount of the transaction price that is allocated to each performance obligation when that performance obligation is satisfied or as it is satisfied.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: 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.
Product Revenue
25 unchanged sentences
For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and therefore within the scope of ASC 606.
−Removed: For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently.
+Added: For elements of
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently.
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.
51 unchanged sentences
Government Grants
−Removed: Government financial incentives that involve no conditions or continuing performance obligations of the Company are recognized as other non-operating income upon receipt.
+Added: Government financial incentives that involve no conditions or continuing performance obligations of the Company are recognized as other (expense) income, net upon receipt.
In the event government grants or incentives involve continuing performance obligations, the Company will capitalize the payment as a liability and recognize the same financial statement caption as the performance obligation relates over the performance period.
−Removed: Comprehensive Loss
−Removed: Comprehensive loss is defined as the changes in equity of the Company during a period from transactions and other events and circumstances excluding transactions resulting from investments by owners and distributions to owners.
−Removed: 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
+Added: The Company received government assistance in the form of cash primarily to support the Guangzhou manufacturing facility build-out and research and development programs.
+Added: Government assistance received related to the Guangzhou manufacturing facility build-out was recognized as other long-term liabilities and is amortized over the same useful lives of the related assets as depreciation expense.
+Added: As of December 31, 2022 and 2021, other long-term liabilities related to the Guangzhou manufacturing facility build-out totaled $ 38,118 and $ 44,593 , respectively.
+Added: For the year ended December 31, 2022, depreciation expense is presented net of amortization of government assistance of $ 3,169 .
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: 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: Government assistance received to support research and development programs was recorded as other long-term liabilities upon receipt and is recognized as other (expense) income , net when the associated research and development programs are completed.
+Added: As of December 31, 2022 and 2021, other long-term liabilities related to research and development programs totaled $ 58 and $ 1,759 , respectively.
+Added: For the year ended December 31, 2022, the Company recognized other income of $ 1,664 upon the completion of a designated research and development program.
+Added: Comprehensive Loss
+Added: Comprehensive loss is defined as the changes in equity of the Company during a period from transactions and other events and circumstances excluding transactions resulting from investments by owners and distributions to owners.
+Added: 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.
+Added: For each of the periods presented, the Company’s comprehensive loss includes net loss, foreign currency translation adjustments, pension liability adjustments and unrealized holding gains/losses associated with the available-for-sale debt securities, and is presented in the consolidated statements of comprehensive loss.
Share-Based Compensation
22 unchanged sentences
Incremental compensation cost is measured as the excess, if any, of the fair value of the modified award over the fair value of the original award immediately before its terms are modified, measured based on the fair value of the awards and other pertinent factors at the modification date.
−Removed: For vested awards, the Company recognizes incremental compensation cost in the period the modification occurs.
−Removed: For unvested awards, the Company recognizes over the remaining requisite service period, the sum of the incremental compensation cost and the remaining unrecognized compensation cost for the original award on the modification date.
−Removed: If the fair value of the modified award is lower than the fair value of the original award immediately before modification, the minimum compensation cost the Company recognizes is the cost of the original award.
−Removed: The Company uses the liability method of accounting for income taxes.
−Removed: Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using enacted tax rates that will be in effect when the differences are expected to reverse.
−Removed: 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: For vested awards, the Company recognizes incremental compensation cost in the period the
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: modification occurs.
+Added: For unvested awards, the Company recognizes over the remaining requisite service period, the sum of the incremental compensation cost and the remaining unrecognized compensation cost for the original award on the modification date.
+Added: If the fair value of the modified award is lower than the fair value of the original award immediately before modification, the minimum compensation cost the Company recognizes is the cost of the original award.
+Added: The Company uses the liability method of accounting for income taxes.
+Added: Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using enacted tax rates that will be in effect when the differences are expected to reverse.
+Added: 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.
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.
20 unchanged sentences
As of December 31, 2022 and 2021, $ 3,869,564 and $ 4,375,678 were deposited with various major reputable financial institutions located in the PRC and international financial institutions outside of the PRC, respectively.
−Removed: The deposits placed with financial institutions are not protected by statutory or commercial insurance.
+Added: The deposits placed with
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: financial institutions are not protected by statutory or commercial insurance.
In the event of bankruptcy of one of these financial institutions, the Company may be unable to claim its deposits back in full.
1 unchanged sentence
As of December 31, 2022 and 2021, the Company had short-term investments amounting to $ 665,251 and $ 2,241,962 , respectively.
−Removed: At December 31, 2021, the Company’s short-term investments were comprised of U.S.
+Added: At December 31, 2022 and 2021, the Company’s short-term investments were comprised of U.S.
treasury securities.
2 unchanged sentences
As of December 31, 2022 and 2021, the Company had accounts receivable, net of $ 173,168 and $ 483,113 , respectively.
−Removed: Accounts receivable, net represent amounts arising from product sales and amounts due from the our collaboration partners.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
+Added: Accounts receivable, net represent amounts arising from product sales and amounts due from its collaboration partners.
The Company monitors economic conditions to identify facts or circumstances that may indicate receivables are at risk of collection.
Customer concentration risk
+Added: For the year ended December 31, 2022, sales to the Company's four largest product distributors, Sinopharm, Shanghai Pharmaceutical, ASD Specialty Healthcare and China Resources represented approximately 18.1 %, 15.5 %, 14.2 % and 12.1 % of product revenue, respectively, and collectively, represented approximately 57.0 % of trade accounts receivable as of December 31, 2022.
+Added: For the year ended December 31, 2022, the Company's collaboration revenue consisted entirely of revenue recognized under its out-licensing collaboration agreements with Novartis.
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.
2 unchanged sentences
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.
−Removed: 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
11 unchanged sentences
A significant portion of the Company’s expenses, assets and liabilities are denominated in RMB.
−Removed: 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).
+Added: In 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).
However, the unification of the exchange rates does not imply that the RMB may be readily convertible into U.S.
3 unchanged sentences
Additionally, the value of the RMB is subject to changes in central government policies and international economic and political developments affecting supply and demand in the PRC foreign exchange trading system market.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Foreign currency exchange rate risk
+Added: The Company is exposed to foreign exchange risk arising from various currency exposures.
+Added: The Company's reporting currency is the U.S.
+Added: dollar, but a portion of its operating transactions and assets and liabilities are in other currencies, such as RMB, Euro, and Australian dollar.
+Added: While the Company holds significant amounts of RMB, and is subject to foreign currency exchange risk upon revaluation or translation into the Company's reporting currency, the Company expects to utilize its existing RMB cash deposits in the operation of its China business over the next several years, and as a result, has not used derivative financial instruments to hedge exposure to such risk.
+Added: RMB is not freely convertible into foreign currencies for capital account transactions.
+Added: The value of RMB against the U.S.
+Added: dollar and other currencies is affected by, among other things, changes in China’s political and economic conditions and China’s foreign exchange prices.
Since July 21, 2005, the RMB is permitted to fluctuate within a narrow and managed band against a basket of certain foreign currencies.
For RMB against U.S.
−Removed: dollar, there was 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.
+Added: dollar, there was depreciation of approximately 8.2 %, appreciation of approximately 2.3 % and appreciation of approximately 6.3 %, in the years ended December 31, 2022, 2021 and 2020.
It is difficult to predict how market forces or PRC or U.S.
8 unchanged sentences
dollar amount available to the Company.
+Added: In 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 foreign cash balances and trade receivables.
+Added: Further, volatility in exchange rate fluctuations may have a significant impact on the foreign currency translation adjustments recorded in other comprehensive income (loss).
+Added: The revaluation impact of foreign currencies held in U.S.
+Added: functional currency subsidiaries may result in significant foreign exchange gains (losses) in the consolidated statement of operations.
+Added: The Company has not used derivative financial instruments to hedge exposure to foreign exchange risk.
+Added: Revision of prior period financial statements
+Added: The Company evaluates the recoverability of its deferred tax assets on a jurisdiction-by-jurisdiction basis by assessing the adequacy of future expected taxable income from all sources, including reversal of temporary differences, forecasted operating earnings and available tax planning strategies in accordance with ASC 740.
+Added: This assessment is subject to a high degree of subjectivity, as the sources of income rely heavily on estimates that are based on a number of factors, including historical experience and short-range and long-range business forecasts.
+Added: A valuation allowance is provided when the Company determines that it is more-likely-than-not that some portion or all of a deferred tax asset will not be realized.
+Added: Prior to the third quarter of 2022, the Company determined that the majority of its net deferred tax assets (primarily in the U.S.) were realizable on a more-likely-than-not basis, primarily due to cumulative pre-tax income at the taxpaying entity and the weighting of available positive and negative evidence.
+Added: Accordingly, no valuation allowance was previously recorded related to those deferred tax assets.
+Added: In October 2022, in connection with the preparation of its condensed consolidated financial statements for the three and nine months ended September 30, 2022, the Company reassessed its position on the realizability of its net deferred tax assets and determined that the negative evidence associated with cumulative losses at the consolidated financial statement level are not able to be overcome by other positive evidence, and therefore, a valuation allowance should be applied to its net deferred tax asset balance.
+Added: The Company determined the previous conclusion to not apply a valuation allowance to certain net deferred tax assets was an error.
+Added: In accordance with Staff Accounting Bulletin (SAB) No.
+Added: 99, “Materiality,” and SAB No.
+Added: 108, “Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements,” the Company evaluated the error and determined that the related impact was not material to any of its previously issued financial statements, but that correcting the cumulative impact of the error would be significant to its statements of operations for the twelve months ended December 31, 2022.
+Added: Accordingly, the Company has revised the annual periods of fiscal year 2021 and 2020 consolidated financial statements and related notes included herein to record a valuation allowance against the Company’s net deferred tax asset balance for all periods presented.
+Added: A summary of revisions to previously reported financial statements is presented in Note 3, Revision of Prior Period Financial Statements.
+Added: Note 12, Income Taxes and Note 16, Loss Per Share have been updated to
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: 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.
+Added: reflect the revision.
+Added: The Company will also correct previously reported financial information for this error in its future filings, as applicable.
Recent Accounting Pronouncements
New accounting standards which have been adopted
−Removed: In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740):
−Removed: Simplifying the Accounting for Income Taxes.
−Removed: This update simplifies the accounting for income taxes as part of the FASB's overall initiative to reduce complexity in accounting standards.
−Removed: 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: Certain amendments in this update should be applied retrospectively or modified retrospectively, and all other amendments should be applied prospectively.
−Removed: The Company adopted this standard on January 1, 2021.
−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
In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832):
3 unchanged sentences
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.
−Removed: The Company does not expect the impact of this guidance to have a material impact on the Company’s consolidated financial statements.
+Added: The Company adopted this standard on January 1, 2022.
+Added: The adoption of this standard has been applied to existing government assistance transactions.
+Added: Revision of Prior Period Financial Statements
+Added: As discussed in Note 2, the Company revised certain prior period financial statements to correct an error related to the valuation of net deferred tax assets, the impact of which was immaterial to our previously filed financial statements in the annual periods of fiscal 2021 and 2020 (See Note 2).
+Added: Specifically, a valuation allowance should have been recorded on all net deferred tax assets and such a valuation allowance was not previously recorded.
+Added: A summary of revisions to the Company’s previously reported financial statements for the comparative periods presented within this Annual Report on Form 10-K is presented below.
+Added: Consolidated Balance Sheet
+Added: December 31, 2021
+Added: As Reported Adjustments As Revised
+Added: Deferred tax assets 110,424 ( 110,424 ) —
+Added: Total non-current assets 1,032,069 ( 110,424 ) 921,645
+Added: Total assets 8,645,949 ( 110,424 ) 8,535,525
+Added: Accumulated deficit ( 4,966,103 ) ( 110,424 ) ( 5,076,527 )
+Added: Total equity 6,242,987 ( 110,424 ) 6,132,563
+Added: Total liabilities and equity 8,645,949 ( 110,424 ) 8,535,525
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: Consolidated Statements of Operations
+Added: Year Ended December 31, Year Ended December 31,
+Added: As Reported Adjustments As Revised As Reported Adjustments As Revised
+Added: Income tax expense (benefit) ( 25,234 ) 44,462 19,228 ( 17,671 ) 28,068 10,397
+Added: Net loss ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,600,523 ) ( 28,068 ) ( 1,628,591 )
+Added: Net loss attributable to BeiGene, Ltd.
+Added: ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,596,906 ) ( 28,068 ) ( 1,624,974 )
+Added: Net loss per share attributable to BeiGene, Ltd., basic and diluted ( 1.17 ) ( 0.04 ) ( 1.21 ) ( 1.47 ) ( 0.03 ) ( 1.50 )
+Added: Net loss per American Depositary Share ("ADS") ( 15.23 ) ( 0.48 ) ( 15.71 ) ( 19.13 ) ( 0.34 ) ( 19.47 )
+Added: Consolidated Statements of Comprehensive Loss
+Added: Year Ended December 31, Year Ended December 31,
+Added: As Reported Adjustments As Revised As Reported Adjustments As Revised
+Added: Net loss ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,600,523 ) ( 28,068 ) ( 1,628,591 )
+Added: Comprehensive loss ( 1,402,346 ) ( 44,462 ) ( 1,446,808 ) ( 1,585,452 ) ( 28,068 ) ( 1,613,520 )
+Added: Comprehensive loss attributable to BeiGene, Ltd.
+Added: ( 1,402,346 ) ( 44,462 ) ( 1,446,808 ) ( 1,581,963 ) ( 28,068 ) ( 1,610,031 )
+Added: Consolidated Statement of Cash Flows
+Added: Year Ended December 31, Year Ended December 31,
+Added: As Reported Adjustments As Revised As Reported Adjustments As Revised
+Added: Operating activities:
+Added: Net loss ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,600,523 ) ( 28,068 ) ( 1,628,591 )
+Added: Adjustments to reconcile net loss to net cash used in operating activities:
+Added: Deferred income tax expense ( 41,085 ) 44,462 3,377 ( 27,807 ) 28,068 261
+Added: Net cash used in operating activities ( 1,298,723 ) — ( 1,298,723 ) ( 1,283,461 ) — ( 1,283,461 )
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: Consolidated Statement of Stockholders' Equity
+Added: Accumulated Deficit Total Equity
+Added: As Reported Adjustments As Revised As Reported Adjustments As Revised
+Added: Balance at December 31, 2019 ( 1,955,843 ) ( 37,894 ) ( 1,993,737 ) 978,355 ( 37,894 ) 940,461
+Added: Net loss ( 1,596,906 ) ( 28,068 ) ( 1,624,974 ) ( 1,600,523 ) ( 28,068 ) ( 1,628,591 )
+Added: Balance at December 31, 2020 ( 3,552,749 ) ( 65,962 ) ( 3,618,711 ) 3,869,243 ( 65,962 ) 3,803,281
+Added: Net loss ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,413,354 ) ( 44,462 ) ( 1,457,816 )
+Added: Balance at December 31, 2021 ( 4,966,103 ) ( 110,424 ) ( 5,076,527 ) 6,242,987 ( 110,424 ) 6,132,563
Collaborative and Licensing Arrangements
3 unchanged sentences
Out-Licensing Arrangements
−Removed: 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.
+Added: During the three years ended December 31, 2022, 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.
The following table summarizes total collaboration revenue recognized for the years ended December 31, 2022, 2021 and 2020:
3 unchanged sentences
License revenue — 484,646 —
−Removed: Reimbursement of research and development costs — — 27,634
Research and development service revenue 46,822 53,671 —
2 unchanged sentences
Total 161,309 542,296 —
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Tislelizumab Collaboration and License
4 unchanged sentences
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.
−Removed: 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: 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
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: combination with its own or third party products.
Each party retains the worldwide right to commercialize its propriety products in combination with tislelizumab.
21 unchanged sentences
Estimated costs to complete are reassessed on a periodic basis and any updates to the revenue earned are recognized on a prospective basis.
−Removed: The Company recognized R&D service revenue of $ 53,421 during the year ended December 31, 2021.
+Added: The Company recognized R&D service revenue of $ 39,655 and $ 53,421 during the years ended December 31, 2022 and 2021, respectively.
+Added: The Company also recognized other collaboration revenue of $ 9,493 related to the sale of tislelizumab clinical supply to Novartis in conjunction with the collaboration during the years ended December 31, 2022.
+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.” In the first quarter of 2022, the Company initiated marketing and promotion of these five products.
+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
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: Ociperlimab Option, Collaboration and License Agreement and China Broad Market Development Agreement
−Removed: 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.
−Removed: 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.”
−Removed: 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.
−Removed: 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: exercise, the Company is eligible to receive up to $ 745,000 upon the achievement of regulatory approval milestones, $ 1,150,000 upon the achievement of sales milestones, and royalties on future sales of ociperlimab in the Novartis Territory.
Subject to the terms of the option, collaboration and license agreement, during the option period, Novartis has agreed to initiate and fund additional global clinical trials with ociperlimab and the Company has agreed to expand enrollment in two ongoing trials.
22 unchanged sentences
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.
−Removed: As such, the entire amount of the
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: transaction price allocated to the material right was deferred.
+Added: As such, the entire amount of the transaction price allocated to the material right was deferred.
The portion of the transaction price allocated to Novartis' right to access ociperlimab in its own clinical trials during the option period and the initial transfer of BeiGene know-how was deferred and is being recognized over the expected option period.
The portion of the transaction price allocated to the R&D Services was deferred and is being recognized as collaboration revenue as the R&D Services are performed over the expected option period.
−Removed: 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.
−Removed: Celgene Corporation, a Bristol Myers Squibb company (BMS)
−Removed: On July 5, 2017, the Company entered into a license agreement with Celgene Corporation, now a BMS company, pursuant to which the Company granted to the BMS parties an exclusive right to develop and commercialize the Company’s investigational PD-1 inhibitor, tislelizumab, in all fields of treatment, other than hematology, in the United States, Europe, Japan and the rest of world other than Asia (the “PD-1 License Agreement”).
−Removed: In connection with the closing of the transactions on August 31, 2017, the Company and BMS amended and restated the PD-1 License Agreement (the “A&R PD-1 License Agreement”) to, among other things, clarify the parties’ responsibilities relating to the conducting and funding of certain global registration clinical trials and clarify the scope of the regulatory materials transferred by BeiGene to BMS.
−Removed: The Company entered into a mutual agreement with BMS to terminate the A&R PD-1 License Agreement effective June 14, 2019 in advance of the acquisition of Celgene by BMS.
−Removed: Under the terms of the A&R PD-1 License Agreement, BMS paid the Company $ 263,000 in upfront non-refundable fees, of which $ 92,050 was paid in the third quarter of 2017 and the remaining $ 170,950 was paid in December 2017.
−Removed: The Company allocated $ 13,000 of upfront fees to the fair value of assets related to the Company’s acquisition of Celgene Shanghai, a wholly-owned subsidiary of Celgene Holdings East Corporation established under the laws of China, which was completed contemporaneously with the A&R PD-1 License Agreement.
−Removed: The Company was also eligible to receive product development and commercial milestone payments based on the successful achievement of development and regulatory and commercialization goals, respectively, and potential royalty payments.
−Removed: In addition to the exclusive right to develop and commercialize tislelizumab, the terms of the A&R PD-1 License Agreement provided BMS with the right to collaborate with the Company on the development of tislelizumab for specified indications, including required participation on a joint development committee and a joint steering committee as well as a joint commercialization committee upon achievement of commercialization.
−Removed: BMS reimbursed the Company for certain research and development costs at a cost plus agreed upon markup for the development of tislelizumab related to the clinical trials that BMS opted into, as outlined in the development plan.
−Removed: Under ASC 606, the Company identified the following deliverables of the collaboration agreement as distinct performance obligations:
−Removed: (a) the license provided to BMS for the exclusive right to develop and commercialize tislelizumab, in all fields of treatment, other than hematology, in the United States, Europe, Japan and the rest of world other than Asia (the "License");
−Removed: and (b) the research and development services provided to BMS to develop tislelizumab within specified indications (R&D services).
−Removed: For each deliverable, the Company determined the stand-alone selling price and allocated the non-constrained consideration of $ 250,000 to the units of accounting using the relative selling price method.
−Removed: The consideration allocated to the License was recognized upon transfer of the License to BMS at contract inception and the consideration allocated to the R&D services was deferred and recognized over the term of the respective clinical studies for the specified indications.
−Removed: The payments associated with the defined developmental, regulatory, and commercialization goals were considered variable consideration and were fully constrained at contract inception through the date of termination.
−Removed: In connection with the termination in June 2019, the Company regained full global rights to tislelizumab and received a $ 150,000 payment from BMS.
−Removed: The payment was recognized as other collaboration revenue upon termination as the Company had no further performance obligations under the collaboration.
−Removed: Upon termination, the Company also recognized the remainder of the deferred revenue balance related to the upfront consideration allocated to research and development services at the time of the original collaboration.
−Removed: 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: 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.
−Removed: This suspension was based on inspection findings at BMS’s contract manufacturing facility in the United States.
−Removed: Additionally, in October 2021, BMS provided 180-days' notice to us, which we dispute, purporting to terminate our license to market ABRAXANE ® in China.
−Removed: We have not had any sales of ABRAXANE ® since the suspension and do not expect future revenue from ABRAXANE ® .
−Removed: We have initiated an
+Added: The Company recognized collaboration revenue of $ 104,994 and $ 3,979 related to Novartis right to access ociperlimab in clinical trials and the transfer of know how performance obligation during the years ended December 31, 2022 and 2021, respectively, and R&D service revenue of $ 7,167 and $ 250 during the years ended December 31, 2022 and 2021, respectively.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: arbitration proceeding against BMS asserting that it has breached and continues to breach the terms and conditions of the license and supply agreement.
−Removed: For additional information, please see the section of this report titled “Legal Proceedings”.
−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.
In-Licensing Arrangements - Commercial
−Removed: 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: In October 2019, the Company entered into a global strategic oncology collaboration with Amgen ("Amgen Collaboration Agreement") for the commercialization and development in China, excluding Hong Kong, Taiwan and Macau, of Amgen’s XGEVA ® , KYPROLIS ® , and BLINCYTO ® , and the joint global development of a portfolio of oncology assets in Amgen’s pipeline, with BeiGene responsible for development and commercialization in China.
The agreement became effective on January 2, 2020, following approval by the Company's shareholders and satisfaction of other closing conditions.
6 unchanged sentences
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: 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.
+Added: In July 2021, KYPROLIS was conditionally approved in China for injection in combination with dexamethasone for the treatment of adult patients with R/R multiple myeloma.
+Added: In April 2022, BLINCYTO was conditionally approved for injection for the treatment of pediatric patients with R/R CD19-positive B-cell precursor ALL.
Amgen and the Company are also jointly developing a portfolio of Amgen oncology pipeline assets under the collaboration.
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 LUMAKRAS™ (sotorasib), Amgen's 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) ("AMG 510"), 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 LUMAKRAS™).
+Added: The Company is also entitled to receive royalties from global sales of each product outside of China (with the exception of AMG 510).
+Added: Amgen advised the Company that its applications to the Human Genetic Resources Administration of China ("HGRAC") to obtain approval to conduct clinical studies in China for the pipeline assets, including its application for AMG 510, were delayed between 2020 and 2022.
+Added: In connection with our ongoing assessment of the Collaboration Agreement cost-share contributions, we determined that our further investment in the development of AMG 510 was no longer commercially viable for BeiGene.
+Added: As a result, in February 2023, we entered into an amendment to the Collaboration Agreement to (i) stop sharing costs with Amgen for the further development of AMG 510 during the period starting January 1, 2023 and ending August 31, 2023;
+Added: and (ii) cooperate in good faith to prepare a transition plan with the anticipated termination of AMG 510 from the Collaboration Agreement.
The Amgen Collaboration Agreement is within the scope of ASC 808, as both parties are active participants and are exposed to the risks and rewards dependent on the commercial success of the activities performed under the agreement.
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
+Added: Per the SPA, the cash proceeds shall be used as necessary to fund the Company's development obligations under the Amgen Collaboration Agreement.
+Added: Pursuant to the SPA, Amgen also received the right to designate one member of the Company's board of directors, and Anthony
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: shall be used as necessary to fund the Company's development obligations under the Amgen Collaboration Agreement.
−Removed: Pursuant to the SPA, Amgen also received the right to designate one member of the Company's board of directors, and Anthony Hooper joined the Company's board of directors as the Amgen designee in January 2020.
+Added: Hooper joined the Company's board of directors as the Amgen designee in January 2020.
+Added: Amgen relinquished its right to appoint a designated director to the Company's board of directors in January 2023.
+Added: On April 20, 2022, the parties entered into the First Amendment to Amgen Collaboration Agreement, which amends certain terms and conditions relating to the financial responsibilities of the parties in connections with the development and commercialization of certain Amgen proprietary products for the treatment of oncology-related diseases and conditions.
In determining the fair value of the common stock at closing, the Company considered the closing price of the common stock on the closing date of the transaction and included a lack of marketability discount because the shares are subject to certain restrictions.
10 unchanged sentences
Total cash proceeds 2,779,241
−Removed: 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:
+Added: Amounts recorded related to the Company's portion of the co-development funding on the pipeline assets for the years ended December 31, 2022, 2021 and 2020 were as follows:
Year Ended December 31,
+Added: 2022 2021 2020
Research and development expense 98,955 115,464 117,005
14 unchanged sentences
except for number of shares and per share data)
−Removed: 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:
+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 three years ended December 31, 2022 as follows:
Year Ended December 31,
+Added: 2022 2021 2020
Cost of sales - product 5,898 1,893 ( 1,210 )
19 unchanged sentences
Our significant license agreements are described below:
+Added: Shandong Luye Pharmaceutical Co., Ltd.
+Added: In December 2022, the Company entered into an exclusive license agreement with Shandong Luye Pharmaceutical Co., Ltd.
+Added: ("Luye") to develop (exclusive of indications for which Luye has submitted the drug marketing authorization application to the China National Medical Products Administration) and commercialize Luye's proprietary goserelin acetate extended-release microspheres for intramuscular injection known as LY01005 in mainland China.
+Added: Under the terms of the agreement, the Company paid Luye an upfront license payment of $ 48,665 , exclusive of VAT, which was recognized as in-process research and development expense, and a prepayment of $ 30,000 to be applied toward future supply purchases in December 2022.
+Added: Luye is also eligible to receive future milestone payments upon achievement of certain regulatory milestones.
+Added: Luye is also eligible to receive tiered royalties on net sales.
+Added: Luye is considered a related party due to a significant common shareholder.
+Added: That shareholder has different representatives serving on each companies' respective board of directors.
Shoreline Biosciences, Inc.
1 unchanged sentence
(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.
−Removed: 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.
−Removed: Clinical development is being led by the Company globally, with Shoreline responsible for clinical manufacturing.
−Removed: The Company has commercial rights globally, with Shoreline having an option to retain commercialization rights in the United States and Canada for two targets.
−Removed: 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.
−Removed: 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.
−Removed: Nanjing Leads Biolabs, Inc.
−Removed: In December 2021, the Company entered into a license and collaboration agreement with Nanjing Leads Biolabs, Inc.
−Removed: (Leads Biolabs) for worldwide research, development and manufacturing rights and exclusive commercialization rights outside
+Added: Under the collaboration, the Company and Shoreline are working jointly to develop cell therapies for four
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: of China to LBL-007, a novel investigational antibody targeting the LAG-3 pathway.
+Added: 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 of China to LBL-007, a novel investigational antibody targeting the LAG-3 pathway.
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.
26 unchanged sentences
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: 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.
−Removed: 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.
−Removed: 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.
−Removed: In November 2019, the Company entered into a l icense agreement with Seagen, Inc.
−Removed: (formerly known as "Seattle Genetics, Inc.") for an advanced pre-clinical product candidate for treating cancer.
−Removed: The agent utilizes a proprietary Seagen antibody-based technology.
−Removed: 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
+Added: The upfront payment was expensed to research and
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: 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.
−Removed: 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 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.
−Removed: 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.
−Removed: 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 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.
−Removed: 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.
−Removed: 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.
−Removed: In addition, Zymeworks will be eligible to receive tiered royalties on future sales of zanidatamab and ZW49 in the licensed territory.
−Removed: 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.
−Removed: In addition, Zymeworks will be eligible to receive tiered royalties on future global sales of bispecific products developed by BeiGene under the agreement.
−Removed: The upfront payments were expensed to research and development expense during the year ended December 31, 2018, in accordance with the Company's acquired in-process research and development expense policy.
−Removed: 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: 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 addition to the collaborations discussed above, the Company has entered into additional collaborative arrangements during the years ended December 31, 2022, 2021 and 2020.
6 unchanged sentences
The Company classifies restricted cash as current or non-current based on term of restriction.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
+Added: In addition to the restricted cash balances above, the Company is required by the PRC securities law to use the proceeds from the STAR offering in strict compliance with the planned uses as disclosed in the PRC prospectus as well as those disclosed in the Company's proceeds management policy approved by the board of directors.
Short-Term Investments
14 unchanged sentences
Accordingly, no allowance for credit loss was recorded as of December 31, 2022.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Equity Securities with Readily Determinable Fair Values
5 unchanged sentences
Inclusive of the shares of common stock issuable upon the exercise of the currently exercisable warrants, the Company's interest is approximately 11.7 %.
−Removed: 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: 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: The Company measures the investment in the common stock and warrants at fair value, with changes in fair value recorded to other (expense) income, net.
+Added: During the years ended December 31, 2022, 2021 and 2020, the Company recorded unrealized (losses) gains of $( 30,102 ), $ 9,386 and $ 12,479 , respectively, in the consolidated statement of operations, respectively.
As of December 31, 2022 and 2021, the fair value of the common stock and warrants was as follows:
5 unchanged sentences
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 $ 43,722 and $ 9,705 in equity securities without readily determinable fair values as of December 31, 2021
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: and 2020, respectively.
−Removed: There were no adjustments to the carrying values of these securities for the year ended December 31, 2021 and 2020.
+Added: The Company held investments of $ 57,054 and $ 43,722 in equity securities without readily determinable fair values as of December 31, 2022 and 2021, respectively.
+Added: The Company recorded gains of $ 5,065 related to observable price changes in orderly transactions for similar investments of the same issuer for the year ended December 31, 2022 to other (expense) income, net in the consolidated statements of operations.
+Added: There were no adjustments to the carrying values of these securities for the years ended December 31, 2021 and 2020.
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 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.
−Removed: 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.
−Removed: SpringWorks purchased 3,500,000 Series A preferred units, or a 25 % ownership interest, and other investors purchased 250,000 Series A preferred units or 1.8 % ownership each.
−Removed: Following the initial closing, the Company consolidated its interests in MapKure under the voting model due to its controlling financial interest.
−Removed: In June 2020, MapKure held a second closing under the existing terms of the SPA in which it issued additional Series A preferred units to SpringWorks and the other investors that purchased units in the first closing (the "Second Closing"), and the Company's ownership interest decreased to 55.6 %.
−Removed: As the requisite Series A voting requirements in MapKure's governing documents require 70 % combined voting power for certain actions, the Company determined that it lost its controlling financial interest after the Second Closing.
−Removed: Therefore, the Company deconsolidated MapKure and recognized a gain of $ 11,307 for the excess of the fair value of its 55.6 % ownership interest in MapKure and carrying amount of the prior non-controlling interest over the carrying amount of MapKure's net assets within other income during the year ended December 31, 2020.
−Removed: Upon deconsolidation, the Company recorded an equity investment of $ 10,000 , which represents the estimated fair value of its 55.6 % ownership interest in MapKure.
−Removed: 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 $ 1,176 and $ 491 for the years ended December 31, 2021 and 2020, respectively.
−Removed: As of December 31, 2021 and 2020, the carrying amount of the Company's investment in MapKure was $ 8,333 and 9,509 , respectively.
−Removed: Guangzhou GET Phase I Biomedical Industry Investment Fund Partnership (Limited Partnership)
−Removed: In July 2020, BeiGene (Guangzhou) invested $ 11,782 (RMB 80,000 ) in an existing investment fund, Guangzhou GET Phase I Biomedical Industry Investment Fund Partnership (Limited Partnership) (GET Bio-fund).
−Removed: 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 six limited partners and one general partner, Guangzhou GET Biomedical Industry Investment Fund Management Co., Ltd.
−Removed: (GET Bio-fund Management).
−Removed: GET Bio-fund has an agreed duration for seven years , with the first five years as the investment period and the following two years as the projected payback period.
−Removed: The agreed upon duration may be extended for two additional years with the approval of all of the partners.
−Removed: As of December 31, 2021, BeiGene Guangzhou, as a limited partner, holds an ownership interest in the fund of 19.3 %.
−Removed: The investment committee for the fund has seven members, and requires resolutions to be approved by at least five of the seven members.
−Removed: BeiGene Guangzhou holds one position on the investment committee and GET Bio-fund Management holds three positions.
−Removed: 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 $ 145 and $ 68 for its portion of the fund's net loss for the years ended December 31, 2021 and 2020, respectively.
−Removed: 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.
−Removed: Other Equity-Method Investment
−Removed: 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.
−Removed: 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.
−Removed: The Company records its share of the investees' results of operations within other income, net.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
+Added: The Company records equity-method investments at cost and subsequently adjusts the basis based on the Company's ownership percentage in the investees' income and expenses, as well as dividends, if any.
+Added: The Company holds equity-method investments totaling $ 27,710 and $ 22,955 as of December 31, 2022 and 2021, respectively, that it does not consider to be individually significant to its financial statements.
+Added: The Company recorded unrealized losses of $ 3,682 , $ 1,796 and $ 491 for the years ended December 31, 2022, 2021 and 2020, respectively, to other (expense) income, net in the consolidated statements of operations.
The Company’s inventory balance consisted of the following:
4 unchanged sentences
Total inventories 282,346 242,626
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Manufacturing Facility in Guangzhou, China
12 unchanged sentences
Upon the transfer of equity in BeiGene Shanghai, BeiGene HK's equity interest in BeiGene Shanghai became 95 %.
−Removed: In September 2020, BeiGene HK entered into a share purchase agreement (JV Share Purchase Agreement) with GET to acquire GET’s 5 % equity interest in BeiGene Biologics for a total purchase price of $ 28,723 (RMB 195,262 ).
+Added: In September 2020, BeiGene HK entered into a share purchase agreement (the "JV Share Purchase Agreement") with GET to acquire GET’s 5 % equity interest in BeiGene Biologics for a total purchase price of $ 28,723 (RMB 195,262 ).
The transaction was finalized in November 2020 upon completion of the business registration filing.
2 unchanged sentences
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 ).
−Removed: In connection with the JV share purchase, the Company entered into a loan agreement with China Minsheng Bank for a total loan facility of up to $ 200,000 (Senior Loan), of which $ 120,000 was used to fund the JV share repurchase and repayment of the shareholder loan and $ 80,000 could be used for general working capital purposes.
+Added: 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 (the "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.
The Company may extend the original maturity date for up to two additional twelve month periods.
1 unchanged sentence
On October 9, 2021, the Company repaid $ 198,320 and drew down $ 200,000 from the Senior Loan .
−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
+Added: In addition, the Company entered into a loan agreement with Zhuhai Hillhouse Zhaohui Equity Investment Partnership (Zhuhai Hillhouse) for a total loan facility of $ 73,640 (RMB 500,000 ) (the "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.
+Added: The Company drew down $ 15,693 (RMB 100,000 ) of the Related Party Loan as of December 31, 2021 and repaid the loan in full in November of 2022.
+Added: See Note 14 for further discussion of the loans.
+Added: The Company has operating leases for office and manufacturing facilities in the United States, Switzerland, and China.
+Added: 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.
+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
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: (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.
−Removed: The Company has drawn down $ 15,693 (RMB 100,000 ) of the Related Party Loan as of December 31, 2021.
−Removed: See Note 13 for further discussion of the loans.
−Removed: The Company has operating leases for office and manufacturing facilities in the United States, Switzerland, and China.
−Removed: 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, 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.
−Removed: 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.
−Removed: 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.
+Added: 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 rights.
+Added: The Company also has certain leases with terms of 12 months or less for certain equipment, office and lab space, which are expensed and not recorded on the balance sheet.
The components of lease expense were as follows:
22 unchanged sentences
Present value of lease liabilities 58,558
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Other supplemental information related to leases is summarized below:
6 unchanged sentences
Weighted-average discount rate 5.76 % 5.15 %
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Property, Plant and Equipment, Net
13 unchanged sentences
The total purchase price was allocated between the land and an existing building on the property based on their relative fair values.
−Removed: The Company plans to construct a biologics manufacturing facility and research and development center on the land.
−Removed: Construction had not yet commenced as of December 31, 2021.
−Removed: 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.
+Added: The Company is constructing a biologics manufacturing facility and research and development center on the land.
+Added: Construction in progress (CIP) a s of December 31, 2022 and 2021 primarily related to the construction of the manufacturing and clinical R&D campus in Hopewell, a new building for Beijing Innerway Bio-tech Co., Ltd., and 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, 2022, 2021 and 2020 were $ 62,302 , $ 44,742 and $ 30,943 , respectively.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Intangible Assets
11 unchanged sentences
Total finite-lived intangible assets 49,551 ( 8,935 ) 40,616 51,710 ( 5,031 ) 46,679
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Product distribution rights consist of distribution rights for the approved cancer therapies licensed from BMS as part of the BMS collaboration.
−Removed: The Company is amortizing the product distribution rights, as a single identified asset, over a period of 10 years from the date of acquisition.
−Removed: 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 product distribution rights, as a single identified asset, over the term of the license agreement of 10 years from the date of acquisition.
+Added: Developed products represent the post-approval milestone payments under license and commercialization agreements.
The Company is amortizing the developed products over the remainder of the respective product patent or the term of the commercialization agreements.
10 unchanged sentences
Amortization expense - Operating expense
−Removed: 750 846 1,326
Total 3,976 1,715 846
8 unchanged sentences
Total 37,116 3,500 40,616
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
The components of income ( loss) before income taxes are as follows:
5 unchanged sentences
Total ( 1,961,037 ) ( 1,438,588 ) ( 1,618,194 )
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The current and deferred components of the income tax expense (benefit) from continuing operations are as follows:
8 unchanged sentences
PRC 3,480 4,919 ( 114 )
−Removed: ( 47,094 ) ( 27,030 ) ( 4,715 )
Other 2 ( 1,704 ) —
24 unchanged sentences
2022 2021 2020
−Removed: Deferred Tax Assets:
+Added: Deferred tax assets (liabilities):
Accruals and reserves 97,896 84,766 33,512
4 unchanged sentences
Lease liability obligation 10,348 11,571 9,066
+Added: R&D and other capitalized costs 63,156 — —
+Added: Right of use asset ( 10,098 ) ( 11,322 ) ( 8,843 )
Gross deferred tax assets 1,927,779 1,744,240 1,189,755
Less valuation allowance ( 1,943,775 ) ( 1,758,409 ) ( 1,200,547 )
−Removed: Total deferred tax assets 107,577 64,013 34,842
−Removed: Deferred tax liabilities:
−Removed: Right of use lease asset ( 11,322 ) ( 8,843 ) ( 7,480 )
−Removed: Total deferred tax liabilities ( 11,322 ) ( 8,843 ) ( 7,480 )
−Removed: Net deferred tax asset 96,255 55,170 27,362
+Added: Net deferred tax liabilities ( 15,996 ) ( 14,169 ) ( 10,792 )
Valuation allowances have been provided on deferred tax assets where, based on all available evidence, it was considered more likely than not that some portion or all of the recorded deferred tax assets will not be realized in future periods.
20 unchanged sentences
federal and state tax credits and incentives.
−Removed: None of the unrecognized tax benefits as of December 31, 2021 would impact the consolidated income tax rate if ultimately recognized due
+Added: None of the unrecognized tax benefits as of December 31, 2022 would impact the consolidated income tax rate if ultimately recognized due to valuation allowances.
+Added: The Company does not anticipate that the amount of existing unrecognized tax benefits will significantly change within the next 12 months.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: to valuation allowances.
−Removed: The Company does not anticipate that the amount of existing unrecognized tax benefits will significantly change within the next 12 months.
The Company has elected to record interest and penalties related to income taxes as a component of income tax expense.
6 unchanged sentences
The income tax benefits attributable to this status for the year ended December 31, 2022 is approximately $ 3,894 , or less than $ 0.01 per share outstanding.
−Removed: 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.
As of December 31, 2022, 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.
4 unchanged sentences
Year Ended December 31,
+Added: 2022 2021 2020
Beginning balance, as of January 1 415 112 —
11 unchanged sentences
Prepaid manufacturing cost 58,950 78,538
+Added: Short-term deposit 1,510 2,982
Other current assets 34,647 24,078
10 unchanged sentences
Prepayment of property and equipment 22,025 14,140
−Removed: Payment of facility capacity expansion activities (1) 24,237 29,778
+Added: Prepaid supply cost (1) 48,642 24,237
Prepaid VAT 804 17,162
2 unchanged sentences
Total 170,413 163,049
−Removed: (1) Represents payments for facility expansion under commercial supply agreements.
+Added: (1) Represents payments for future supply purchases under the license agreement with Luye and facility expansion under commercial supply agreements.
The payments are providing future benefit to the Company through credits on commercial supply purchases.
13 unchanged sentences
Total other long-term liabilities 46,095 54,234
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
The following table summarizes the Company's short-term and long-term debt obligations as of December 31, 2022 and 2021:
4 unchanged sentences
January 20, 2029 (2) 1,450 10,000 1,569 10,000
+Added: China Merchants Bank November 9, 2020 RMB 378,000 9 -year
+Added: November 8, 2029 (3) 5,437 37,500 — —
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
China Minsheng Bank (the "Senior Loan") September 24, 2020 $ 200,000 (4) 4.3 % 150,000 1,034,554 200,000 1,274,535
Zhuhai Hillhouse (the "Related Party Loan") September 24, 2020 RMB 500,000 (5) 4.5 % — — 15,693 100,000
+Added: Shanghai Pudong Development Bank February 25, 2022 $ 50,000 1 -year
+Added: February 25, 2023 2.2 % 50,000 344,851 — —
Other short-term debt (6) 114,832 792,000 209,048 1,332,197
6 unchanged sentences
November 8, 2029 (3) 47,847 330,000 59,316 378,000
+Added: China CITIC Bank July 29, 2022 RMB 480,000 10 -year
+Added: July 28, 2032 (7) 36,537 252,000 — —
Total long-term debt 209,148 1,442,500 202,113 1,288,000
3 unchanged sentences
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.
−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.
+Added: On January 22, 2020, BeiGene Guangzhou Biologics Manufacturing Co., Ltd.("BeiGene Guangzhou Factory") entered into a nine-year bank loan with China Merchants Bank to borrow up to RMB 1,100,000 at a floating interest rate benchmarked against prevailing interest rates of certain PRC financial institutions.
The loan is secured by Guangzhou Factory's second land use right and fixed assets that will be placed into service upon completion of the second phase of the Guangzhou manufacturing facility's build out.
1 unchanged sentence
The loan interest rate was 4.4 % as of December 31, 2022.
−Removed: $ 120,000 of the Senior Loan was designated to fund the JV share purchase and repayment of the shareholder loan and $ 80,000 was designated for general working capital purposes.
+Added: The Company repaid $ 1,484 (RMB 10,000 ) during the year ended December 31, 2022 .
+Added: BeiGene Guangzhou Biologics Manufacturing Co., Ltd.
+Added: is a company incorporated under the laws of the PRC on March 3, 2017 and a wholly owned subsidiary of BeiGene Biologics.
+Added: The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC.
+Added: The loan interest rate was 4.0 % as of December 31, 2022.
+Added: The loan is secured by fixed assets that will be placed into service upon completion of the third phase of the Guangzhou manufacturing facility's build out.
+Added: In September 2020, the Company entered into a loan agreement with China Minsheng Bank for a total loan facility of up to $ 200,000 , of which $ 120,000 was designated to fund the JV share purchase and repayment of the Shareholder Loan and $ 80,000 was designated for general working capital purposes.
The Senior Loan had an original maturity date of October 8, 2021, which was the first anniversary of the first date of utilization of the loan.
1 unchanged sentence
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 September 30, 2022, the Company entered into an amendment and restatement agreement with China Minsheng Bank to extend the maturity date.
On October 10, 2022, the Company repaid $ 200,000 and drew down $ 150,000 from the Senior Loan.
−Removed: RMB 100,000 of the Related Party Loan was designated for general corporate purposes and RMB 400,000 was designated for repayment of the Senior Loan, including principal, interest and fees.
+Added: In September 2020, 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 ), 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 loan originally matured at the earlier of:
2 unchanged sentences
(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.
+Added: On October 10, 2022, the Company repaid in full the outstanding borrowing in the amount of $ 13,980 (RMB 100,000 ).
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 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.
+Added: During the three years ended December 31, 2022, the Company entered into additional short-term working capital loans with China Industrial Bank and China Merchants Bank to borrow up to RMB 2,435,000 in aggregate, with maturity dates ranging from January 19, 2021 to September 18, 2023.
The Company drew down $ 113,774 (RMB 792,000 ) during the year ended December 31, 2022.
2 unchanged sentences
The weighted average interest rate for the short-term working capital loans was approximately 2.6 % as of December 31, 2022.
−Removed: The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC.
+Added: In July 2022, the Company entered into a 10 -year bank loan agreement with China CITIC Bank to borrow up to RMB 480,000 at a floating interest rate benchmarked against prevailing interest rates of certain PRC financial institutions.
The loan interest rate was 4.2 % as of December 31, 2022 .
+Added: The loan is secured by BeiGene Suzhou Co., Ltd.'s land use right.
The Company drew down $ 37,372 (RMB 252,000 ) during the year ended December 31, 2022.
−Removed: 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.
BEIGENE, LTD.
20 unchanged sentences
REVLIMID ® and VIDAZA ® in China under a license from BMS;
−Removed: and XGEVA ® and BLINCYTO ® in China under a license from Amgen.
+Added: XGEVA, BLINCYTO and KYPROLIS in China under a license from Amgen;
+Added: and POBEVCY in China under a license from Bio-Thera.
The table below presents the Company’s net product sales for the years ended December 31, 2022, 2021 and 2020.
4 unchanged sentences
Product revenue - net 1,254,612 633,987 308,874
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The following table disaggregates net product revenue by product for the years ended December 31, 2022, 2021 and 2020.
1 unchanged sentence
2022 2021 2020
+Added: 564,651 217,987 41,702
Tislelizumab 422,885 255,119 163,358
4 unchanged sentences
15,213 19,591 29,975
+Added: Pamiparib 5,460 3,661 —
Other 16,029 7,740 201
Total product revenue - net 1,254,612 633,987 308,874
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
The following table presents the roll-forward of accrued sales rebates and returns for the years ended December 31, 2022 and December 31, 2021.
4 unchanged sentences
Ending balance, as of December 31 41,817 59,639
−Removed: 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.
−Removed: The impact of the NRDL price reductions on net revenue totaled $ 57,450 for the year ended December 31, 2021.
−Removed: The majority of the accrued compensation related to sales of tislelizumab.
Loss Per Share
9 unchanged sentences
For the years ended December 31, 2022, 2021 and 2020, the computation of basic loss per share using the two-class method was not applicable, as the Company was in a net loss position.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The effects of all share options and restricted share units were excluded from the calculation of diluted loss per share as their effect would have been anti-dilutive during the years ended December 31, 2022, 2021 and 2020.
−Removed: Share-Based Compensation Expense
+Added: Share-Based Compensation
2016 Share Option and Incentive Plan
4 unchanged sentences
The 2016 Plan provided for an annual increase in the shares available for issuance, to be added on the first day of each fiscal year, beginning on January 1, 2017, equal to the lesser of (i) five percent ( 5 )% of the outstanding shares of the Company's ordinary shares on the last day of the immediately preceding fiscal year or (ii) such number of shares determined by the Company’s board of directors or the compensation committee.
−Removed: On January 1, 2018, 29,603,616 ordinary shares were added
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: to the 2016 Plan under this provision.
+Added: On January 1, 2018, 29,603,616 ordinary shares were 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.
4 unchanged sentences
As of December 31, 2022, share-based awards to acquire 75,034,504 ordinary shares were available for future grant under the 2016 Plan.
+Added: In order to continue to provide incentive opportunities under the 2016 Plan, the Board of Directors and shareholders of the Company approved an amendment to the 2016 Plan (the "Amendment No.
+Added: 2"), which became effective as of June 22, 2022, to increase the number of authorized shares available for issuance under the 2016 Plan by 66,300,000 ordinary shares, or 5 %, of the Company's outstanding shares as of March 31, 2022.
2018 Inducement Equity Plan
3 unchanged sentences
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.
−Removed: As of December 31, 2021, share-based awards to acquire 9,344,659 ordinary shares were available for future grant under the 2018 Plan.
+Added: Upon the effectiveness of Amendment No.
+Added: 2 to the 2016 Plan, on June 22, 2022, the 2018 Plan was terminated to the effect that no new equity awards shall be granted under the plan but the outstanding equity awards under the plan shall continue to vest and/or be exercisable in accordance with their terms.
2018 Employee Share Purchase Plan
1 unchanged sentence
Initially, 3,500,000 ordinary shares of the Company were reserved for issuance under the ESPP.
−Removed: 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 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.
−Removed: 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.
−Removed: Eligible employees are able to authorize payroll deductions of up to 10 % of their eligible earnings, subject to applicable limitations.
+Added: 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
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: the HKEx rules.
+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.
+Added: 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.
+Added: Eligible employees are able to authorize payroll deductions of up to 10 % of their eligible earnings, subject to applicable limitations.
The following tables summarizes the shares issued under the ESPP:
14 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.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The following table summarizes the Company’s share option activities under the 2011, 2016 and 2018 Plans:
21 unchanged sentences
This unrecognized compensation will be recognized over an estimated weighted-average amortization period of 2.4 years.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: 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, 2022, 2021 and 2020 was $ 62,548 , $ 53,571 and $ 55,127 , respectively.
19 unchanged sentences
Contractual life 10 years 10 years 10 years
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Restricted shares
6 unchanged sentences
Outstanding at December 31, 2020 — —
−Removed: Vested ( 75,000 ) 2.27
−Removed: Forfeited — —
−Removed: Outstanding at December 31, 2020 — —
−Removed: Forfeited — —
−Removed: Outstanding at December 31, 2021 — —
−Removed: Expected to vest at December 31, 2021 — —
−Removed: The Company had no non-employee restricted share activities during the year ended December 31, 2021 and 2020.
+Added: The Company had no restricted share activities during the year ended December 31, 2022 and 2021.
As of December 31, 2022, all compensation cost related to restricted shares was fully recognized.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: 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 2.9 years.
+Added: Share-based compensation expense
The following table summarizes total share-based compensation cost recognized for the years ended December 31, 2022, 2021 and 2020:
10 unchanged sentences
except for number of shares and per share data)
−Removed: Accumulated Other Comprehensive Income (Loss)
−Removed: The movement of accumulated other comprehensive income (loss) was as follows:
+Added: Accumulated Other Comprehensive (Loss) Income
+Added: The movement of accumulated other comprehensive (loss) income was as follows:
Foreign Currency
5 unchanged sentences
Other comprehensive income (loss) before reclassifications 13,714 ( 4,504 ) 309 9,519
−Removed: Amounts reclassified from accumulated other comprehensive income (loss) (1) — ( 1,492 ) — ( 1,492 )
+Added: Amounts reclassified from accumulated other comprehensive (loss) income (1) — ( 67 ) 1,556 1,489
Net-current period other comprehensive (loss) income 13,714 ( 4,571 ) 1,865 11,008
1 unchanged sentence
Other comprehensive income (loss) before reclassifications ( 90,421 ) ( 5,311 ) ( 446 ) ( 96,178 )
−Removed: Amounts reclassified from accumulated other comprehensive income (loss) (1) — ( 67 ) 1,556 1,489
+Added: Amounts reclassified from accumulated other comprehensive (loss) income (1) — — 811 811
Net-current period other comprehensive (loss) income ( 90,421 ) ( 5,311 ) 365 ( 95,367 )
December 31, 2022 ( 62,523 ) ( 9,011 ) ( 5,883 ) ( 77,417 )
−Removed: (1) The amounts reclassified from accumulated other comprehensive (loss) income were included in other income, net in the consolidated statements of operations.
+Added: (1) The amounts reclassified from accumulated other comprehensive (loss) income were included in other (expense) income, net in the consolidated statements of operations.
Shareholders’ Equity
29 unchanged sentences
In this offering, the Company sold 115,055,260 ordinary shares.
−Removed: Net proceeds after deducting underwriting discounts and commission and offering expenses were $ 3,392,616 .
+Added: Net proceeds after deducting underwriting commission and offering expenses were $ 3,392,616 .
As required by the PRC securities laws, the net proceeds from the STAR Offering must be used in strict compliance with the planned uses as disclosed in the PRC prospectus as well as the Company's proceeds management policy for the STAR Offering approved by the board of directors.
47 unchanged sentences
Capital commitments
−Removed: 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: The Company had capital commitments amounting to $ 404,914 for the acquisition of property, plant and equipment as of December 31, 2022, which were mainly for the Company’s manufacturing and clinical R&D campus in Hopewell, NJ, additional capacity at the Guangzhou and Suzhou manufacturing facilities, and a new building for Beijing Innerway Bio-tech Co., Ltd.
Co-development funding commitment
10 unchanged sentences
Research and Development Commitment
−Removed: 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: The Company entered into long-term research and development agreements, which include obligations to make upfront payments and fixed quarterly payments over the next four years .
As of December 31, 2022, the total research and development commitment amounted to $ 22,327 .
Funding Commitment
−Removed: The Company had committed capital related to an equity method investment in the amount of $ 15,000 .
+Added: The Company had committed capital related to two equity method investments in the amount of $ 19,000 .
As of December 31, 2022, the remaining capital commitment was $ 16,000 and is expected to be paid from time to time over the investment period.
11 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, with the exception of land which is in the U.S.
+Added: The Company’s long-lived assets are primarily located in the PRC and the U.S.
Net product revenues by geographic area are based upon the location of the customer, and net collaboration revenue is recorded in the jurisdiction in which the related income is expected to be sourced from.
8 unchanged sentences
revenues for the year ended December 31, 2022 consisted of collaboration revenues of $ 112,916 and BRUKINSA product sales of $ 389,710 , respectively.
+Added: revenues for the year ended December 31, 2021 consisted of collaboration revenue of $ 379,607 and BRUKINSA product sales of $ 115,658 , respectively.
revenues for the year ended December 31, 2020 consisted entirely of BRUKINSA product sales.
−Removed: revenues for the year ended December 31, 2019 consisted primarily of collaboration revenues.
−Removed: Rest of world revenues for each of the three years in the period ended December 31, 2021 consisted primarily of collaboration revenues.
+Added: Rest of world revenues for each of the year ended December 31, 2022 consisted of collaboration revenues of $ 48,393 and product sales of $ 24,870 , respectively.
+Added: Rest of world revenues for each of the year ended December 31, 2021 consisted primarily of collaboration revenues.
+Added: Supplementary Information
+Added: The Company's 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.
+Added: 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.
+Added: As discussed in Note 2, the Company revised certain prior period financial statements to correct an error related to the valuation of net deferred tax assets, the impact of which was immaterial to its previously filed financial statements in the annual periods of fiscal 2021 and 2020.
+Added: The following table summarizes the unaudited statements of operations for each quarter of 2022 and 2021 (in thousands except share and per share amounts).
+Added: Quarter Ended
+Added: March 31, June 30, September 30, December 31,
+Added: Total revenues 306,626 341,572 387,628 380,095
+Added: Loss from operations (443,287) (439,399) (438,357) (468,622)
+Added: Net loss (435,198) (565,726) (557,556) (445,335)
+Added: Net loss attributable to BeiGene, Ltd.
+Added: (435,198) (565,726) (557,556) (445,335)
+Added: Net loss per share attributable to BeiGene, Ltd., basic and diluted (0.33) (0.42) (0.41) (0.33)
+Added: Quarter Ended
+Added: March 31, June 30, September 30, December 31,
+Added: Total revenues 605,872 149,992 206,440 213,979
+Added: Income (loss) from operations 70,167 (474,838) (462,325) (571,739)
+Added: Net income (loss) 55,580 (484,604) (438,114) (590,678)
+Added: Net income (loss) attributable to BeiGene, Ltd.
+Added: 55,580 (484,604) (438,114) (590,678)
+Added: Net income (loss) per share attributable to BeiGene, Ltd., basic 0.05 (0.41) (0.36) (0.48)
+Added: Net income (loss) per share attributable to BeiGene, Ltd., diluted 0.04 (0.41) (0.36) (0.48)
Exhibit Index
22 unchanged sentences
(Exhibit 10.21) 1/27/2016 333-207459
−Removed: 4.5 .1 Registration Rights Agreement, dated as of November 16, 2016, by and among BeiGene, Ltd.
−Removed: and the investors named therein
+Added: 4.5 .1 Registration Rights Agreement, dated as of November 16, 2016, by and among the Registrant and the investors named therein
(Exhibit 4.1) 11/17/2016 001-37686
2 unchanged sentences
(Exhibit 10.1) 12/2/2020 001-37686
−Removed: 4.6 Description of BeiGene, Ltd.'s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934
+Added: 4.6 Description of the Registrant 's Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934
Collaboration, License and Commercial Agreements
19 unchanged sentences
(Exhibit 10.1) 9/24/2020 001-37686
−Removed: 10.5## Collaboration Agreement, dated October 31, 2019, by and among the Registrant, BeiGene Switzerland GmbH and Amgen Inc.
−Removed: (Exhibit 10.11) 3/2/2020 001-37686
+Added: .4 Amendment No.
+Added: 3 to Share Purchase Agreement, dated January 30, 2023, by and between the Registrant and Amgen Inc.
Exhibit Description Filed/ Furnished
1 unchanged sentence
Herein from Form or Schedule Filing Date SEC File/
+Added: 10.5## .1## Collaboration Agreement, dated October 31, 2019, by and among the Registrant, BeiGene Switzerland GmbH and Amgen Inc.
+Added: (Exhibit 10.11) 3/2/2020 001-37686
+Added: .2## First Amendment to Collaboration Agreement, dated April 20, 2022, by and among the Registrant, BeiGene Switzerland GmbH and Amgen Inc.
+Added: (Exhibit 10.1) 8/8/2022 001-37686
10.6 Guarantee, dated October 31, 2019, by and between the Registrant and Amgen Inc.
3 unchanged sentences
.2## Option, Collaboration and License Agreement, dated December 19, 2021, by and between BeiGene Switzerland GmbH and Novartis Pharma AG
+Added: (Exhibit 10.7.2) 2/28/2022 001-37686
Equity and Other Compensation Plans
6 unchanged sentences
(Exhibit 10.1) 6/17/2020 001-37686
+Added: .3† Amendment No.
+Added: 2 to the Second Amended and Restated 2016 Share Option and Equity Plan
+Added: (Exhibit 10.1) 6/22/2022 001-37686
.4† Form of Global Restricted Share Unit Award Agreement for Non-Employee Directors under the Second Amended and Restated 2016 Share Option and Incentive Plan
10 unchanged sentences
(Exhibit 10.8) 8/8/2022 001-37686
−Removed: 10.10† .1† Amended and Restated 2018 Inducement Equity Plan
−Removed: (Exhibit 10.1) 8/13/2018 001-37686
−Removed: .2† Form of Non-Qualified Share Option Agreement under the 2018 Inducement Equity Plan
−Removed: (Exhibit 10.3) 6/8/2018 001-37686
−Removed: .3† Form of Restricted Share Unit Award Agreement under the 2018 Inducement Equity Plan
−Removed: (Exhibit 10.5) 8/9/2018 001-37686
10.10† .1† Third Amended and Restated 2018 Employee Share Purchase Plan
(Exhibit 10.7) 8/5/2021 001-37686
−Removed: 10.12† Senior Executive Cash Incentive Bonus Plan
−Removed: (Exhibit 10.19) 1/19/2016 333-207459
Exhibit Description Filed/ Furnished
1 unchanged sentence
Herein from Form or Schedule Filing Date SEC File/
+Added: 10.11† Senior Executive Cash Incentive Bonus Plan
+Added: (Exhibit 10.19) 1/19/2016 333-207459
10.12† Independent Director Compensation Policy, as amended
13 unchanged sentences
(Exhibit 10.9) 8/5/2021 001-37686
−Removed: 10.18† Employment Agreement, dated as of August 19, 2016, by and between BeiGene USA, Inc.
−Removed: and Jane Huang
−Removed: (Exhibit 10.2) 11/10/2016 001-37686
10.18† Consulting Agreement, dated February 24, 2021, by and between the Registrant and Xiaodong Wang
1 unchanged sentence
10.19† Employment Agreement, dated December 30, 2021, by and between BeiGene (Shanghai) Co., Ltd.
+Added: (Exhibit 10.20) 2/28/2022 001-37686
+Added: 16.1 Letter from Ernst & Young Hua Ming LLP addressed to the U.S.
+Added: Securities and Exchange Commission dated March 25, 2022
+Added: (Exhibit 16.1) 3/25/2022 001-37686
21.1 List of Subsidiaries of the Registrant
2 unchanged sentences
Herein from Form or Schedule Filing Date SEC File/
+Added: 23.1 Consent of Ernst & Young LLP
23.2 Consent of Ernst & Young Hua Ming LLP
3 unchanged sentences
Section 1350, as adopted pursuant to Section 906 of the Sarbanes‑Oxley Act of 2002
+Added: 99.1 Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
101.INS Inline XBRL Instance Document - the instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document
8 unchanged sentences
Securities and Exchange Commission as to certain portions of this exhibit omitted and filed separately.
−Removed: ## Certain portions of the exhibit have been omitted by means of redacting a portion of the text and replacing it with "[...***...]".
−Removed: BeiGene, Ltd.
−Removed: (the Registrant) has determined that the omitted information (i) is not material and (ii) would be competitively harmful if publicly disclosed.
+Added: ## Certain portions of the exhibit have been omitted by means of redacting a portion of the text and replacing it with "[*]", because they are both (i) not material and (ii) the type of information that the Registrant treats as private or confidential.
* Furnished herewith.
6 unchanged sentences
Each person whose individual signature appears below hereby authorizes and appoints John V.
−Removed: Oyler, Julia Wang, and Scott A.
−Removed: 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.
+Added: Oyler, Julia Wang, and Chan Lee, 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.
Pursuant to the requirements of the Securities Exchange Act of 1934, this Annual Report on Form 10‑K has been signed by the following persons in the capacities indicated below and on the dates indicated:
4 unchanged sentences
Julia Wang (Principal Financial and Accounting Officer)
−Removed: /s/ TIMOTHY CHEN Director February 28, 2022
−Removed: /s/ DONALD W.
−Removed: GLAZER Director February 28, 2022
/s/ MARGARET DUGAN Director February 27, 2023
Margaret Dugan
+Added: /s/ DONALD W.
+Added: GLAZER Director February 27, 2023
/s/ MICHAEL GOLLER Director February 27, 2023
6 unchanged sentences
Thomas Malley
−Removed: /s/ XIAODONG WANG Director February 28, 2022
−Removed: Xiaodong Wang
/s/ ALESSANDRO RIVA Director February 27, 2023
3 unchanged sentences
Corazon (Corsee) D.
+Added: /s/ XIAODONG WANG Director February 27, 2023
+Added: Xiaodong Wang
/s/ QINGQING YI Director February 27, 2023
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.