Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Based on their evaluation, required by paragraph (b) of Rules 13a-15 or 15d-15, promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act are effective, at a reasonable assurance level, as of December 31, 2022, to ensure that information required to be disclosed in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in U.S. Securities and Exchange Commission rules and forms. 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. 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
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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
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act). Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. 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.
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our assessment and those criteria, management concluded that we maintained effective internal control over financial reporting as of December 31, 2022.
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
There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a‑15(d) and 15d‑15(d) of the Exchange Act that occurred during the three months ended December 31, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
On October 31, 2019, our wholly-owned subsidiary, BeiGene Switzerland GmbH (“BeiGene Switzerland”), entered into a collaboration agreement with Amgen Inc. (“Amgen”), which became effective on January 2, 2020 (as amended, the "Collaboration Agreement"). 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. 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. 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; and (ii) cooperate in good faith to prepare a transition plan with the anticipated termination of AMG 510 from the Collaboration Agreement. 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.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
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. 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. 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. 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. 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.
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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. 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.
To the extent known by the Company, the Company is not aware of and has no reason to believe that: 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; any official of the Chinese government or Hong Kong SAR is a board member or officer of the Company or its operating subsidiaries; 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. 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. 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.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the U.S. Securities and Exchange Commission not later than 120 days after the close of our fiscal year ended December 31, 2022.
Item 11. Executive Compensation
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the U.S. Securities and Exchange Commission not later than 120 days after the close of our fiscal year ended December 31, 2022.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the U.S. Securities and Exchange Commission not later than 120 days after the close of our fiscal year ended December 31, 2022.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the U.S. Securities and Exchange Commission not later than 120 days after the close of our fiscal year ended December 31, 2022.
Item 14. Principal Accounting Fees and Services
Our independent public accounting firm is Ernst & Young LLP (PCAOB ID: 00 42 ), located in Boston, Massachusetts, United States. 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.
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the U.S. Securities and Exchange Commission not later than 120 days after the close of our fiscal year ended December 31, 2022.
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PART IV
Item 15. Exhibits, Financial Statement Schedules
The financial statements listed in the Index to Consolidated Financial Statements beginning on page F-1 are filed as part of this Annual Report.
No financial statement schedules have been filed as part of this Annual Report because they are not applicable, not required or the information required is shown in the financial statements or the notes thereto.
The exhibits filed as part of this Annual Report are set forth on the Exhibit Index immediately following our consolidated financial statements. The Exhibit Index is incorporated herein by reference.
Item 16. Form 10‑K Summary
Not applicable.
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BEIGENE, LTD.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Reports of Independent Registered Public Accounting Firm
2
Consolidated balance sheets as of December 31, 202 2 and 202 1
6
Consolidated statements of operations for the years ended December 31, 20 22 , 202 1 and 20 20
7
Consolidated statements of comprehensive loss for the years ended December 31, 202 2 , 202 1 and 20 20
8
Consolidated statements of cash flows for the years ended December 31, 202 2 , 202 1 and 20 20
9
Consolidated statements of shareholders’ equity for the years ended December 31, 202 2 , 202 1 and 20 20
10
Notes to consolidated financial statements
11
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Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of BeiGene, Ltd.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of BeiGene, Ltd. 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”). 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.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 27, 2023 expressed an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company's management. 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.
We conducted our audit in accordance with the standards of the PCAOB. 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. 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. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. 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. We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matters
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: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. 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.
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Accrued Clinical Trial Expenses
Description of the Matter As of December 31, 2022, the Company recorded $138 million of accrued external research and development expenses. 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. Expenses related to clinical trials are accrued based on estimates of the actual services performed by third parties for the respective period. 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.
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. 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. 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. 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.
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. 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.
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. 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. We also tested subsequent invoices received and evaluated contractual arrangements with vendors, including any pending change orders to assess the impact to the accrual.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2022
Boston, Massachusetts
February 27, 2023
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Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of BeiGene, Ltd.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of BeiGene, Ltd. (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"). 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. generally accepted accounting principles.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. 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. 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. 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. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Ernst & Young Hua Ming LLP
We served as the Company’s auditor from 2014 to 2022.
Beijing, People’s Republic of China
February 28, 2022,
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
February 27, 2023
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Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of BeiGene, Ltd.
Opinion on Internal Control Over Financial Reporting
We have audited BeiGene, Ltd.’s internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, BeiGene, Ltd. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2022, based on the COSO criteria.
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
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. 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.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. 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.
/s/ Ernst & Young LLP
Boston, Massachusetts
February 27, 2023
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BEIGENE, LTD.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
As of December 31,
Note 2022 2021
$ $
Assets
Current assets:
Cash and cash equivalents 3,869,564 4,375,678
Short-term restricted cash 5 196 328
Short-term investments 6 665,251 2,241,962
Accounts receivable, net 173,168 483,113
Inventories 7 282,346 242,626
Prepaid expenses and other current assets 13 216,553 270,173
Total current assets 5,207,078 7,613,880
Long-term restricted cash 5 5,277 6,881
Property, plant and equipment, net 10 845,946 587,605
Operating lease right-of-use assets 9 109,960 117,431
Intangible assets, net 11 40,616 46,679
Other non-current assets 13 170,413 163,049
Total non-current assets 1,172,212 921,645
Total assets 6,379,290 8,535,525
Liabilities and shareholders' equity
Current liabilities:
Accounts payable 294,781 262,400
Accrued expenses and other payables 13 467,352 558,055
Deferred revenue, current portion 4 213,861 187,414
Tax payable 12 25,189 21,395
Operating lease liabilities, current portion 9 24,041 21,925
Research and development cost share liability, current portion 4 114,335 120,801
Short-term debt 14 328,969 427,565
Total current liabilities 1,468,528 1,599,555
Non-current liabilities:
Long-term debt 14 209,148 202,113
Deferred revenue, non-current portion 4 42,026 220,289
Operating lease liabilities, non-current portion 9 34,517 43,041
Deferred tax liabilities 12 15,996 14,169
Research and development cost share liability, non-current portion 4 179,625 269,561
Other long-term liabilities 13 46,095 54,234
Total non-current liabilities 527,407 803,407
Total liabilities 1,995,935 2,402,962
Commitments and contingencies 22
Equity:
Ordinary shares, 0.0001 par value per share; 9,500,000,000 shares authorized; 1,356,140,180 and 1,334,804,281 shares issued and outstanding as of December 31, 2022 and 2021, respectively
135 133
Additional paid-in capital 11,540,979 11,191,007
Accumulated other comprehensive (loss) income 18 ( 77,417 ) 17,950
Accumulated deficit ( 7,080,342 ) ( 5,076,527 )
Total equity 4,383,355 6,132,563
Total liabilities and equity 6,379,290 8,535,525
The accompanying notes are an integral part of these consolidated financial statements.
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BEIGENE, LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
Year Ended December 31,
Note 2022 2021 2020
$ $ $
Revenues
Product revenue, net 15 1,254,612 633,987 308,874
Collaboration revenue 4 161,309 542,296 —
Total revenues 1,415,921 1,176,283 308,874
Expenses
Cost of sales - product 286,475 164,906 70,657
Research and development 1,640,508 1,459,239 1,294,877
Selling, general and administrative 1,277,852 990,123 600,176
Amortization of intangible assets 11 751 750 846
Total expenses 3,205,586 2,615,018 1,966,556
Loss from operations ( 1,789,665 ) ( 1,438,735 ) ( 1,657,682 )
Interest income (expense), net 52,480 ( 15,757 ) 1,998
Other (expense) income, net 6 ( 223,852 ) 15,904 37,490
Loss before income taxes ( 1,961,037 ) ( 1,438,588 ) ( 1,618,194 )
Income tax expense 12 42,778 19,228 10,397
Net loss ( 2,003,815 ) ( 1,457,816 ) ( 1,628,591 )
Less: net loss attributable to noncontrolling interests — — ( 3,617 )
Net loss attributable to BeiGene, Ltd. ( 2,003,815 ) ( 1,457,816 ) ( 1,624,974 )
Net loss per share attributable to BeiGene, Ltd., basic and diluted 16 ( 1.49 ) ( 1.21 ) ( 1.50 )
Weighted-average shares outstanding, basic and diluted 16 1,340,729,572 1,206,210,049 1,085,131,783
Net loss per American Depositary Share (ADS), basic and diluted ( 19.43 ) ( 15.71 ) ( 19.47 )
Weighted-average ADSs outstanding, basic and diluted 103,133,044 92,785,388 83,471,676
The accompanying notes are an integral part of these consolidated financial statements.
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BEIGENE, LTD.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
Year Ended December 31,
Note 2022 2021 2020
$ $ $
Net loss ( 2,003,815 ) ( 1,457,816 ) ( 1,628,591 )
Other comprehensive (loss) income, net of tax of nil:
Foreign currency translation adjustments 18 ( 90,421 ) 13,714 23,603
Pension liability adjustments 21 365 1,865 ( 8,113 )
Unrealized holding loss, net 18 ( 5,311 ) ( 4,571 ) ( 419 )
Comprehensive loss ( 2,099,182 ) ( 1,446,808 ) ( 1,613,520 )
Less: comprehensive loss attributable to noncontrolling interests — — ( 3,489 )
Comprehensive loss attributable to BeiGene, Ltd. ( 2,099,182 ) ( 1,446,808 ) ( 1,610,031 )
The accompanying notes are an integral part of these consolidated financial statements.
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BEIGENE, LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
Year Ended December 31,
Note 2022 2021 2020
$ $ $
Cash flows from operating activities:
Net loss ( 2,003,815 ) ( 1,457,816 ) ( 1,628,591 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense 66,278 46,457 31,789
Share-based compensation expense 17 303,162 240,712 183,481
Acquired in-process research and development 4 68,665 83,500 109,500
Amortization of research and development cost share liability 4 ( 96,402 ) ( 112,486 ) ( 113,986 )
Unrealized losses (gains) on equity investments 6 21,996 ( 7,632 ) ( 11,826 )
Deferred income tax expense 2,059 3,377 261
Other items, net 9,047 23,510 ( 4,673 )
Changes in operating assets and liabilities:
Accounts receivable 304,112 ( 423,019 ) 10,363
Inventories ( 56,689 ) ( 153,333 ) ( 58,906 )
Other assets ( 3,282 ) ( 107,128 ) ( 56,217 )
Accounts payable ( 4,352 ) 20,008 95,835
Accrued expenses and other payables 45,627 140,044 185,012
Deferred revenue ( 151,816 ) 407,703 —
Other liabilities ( 1,209 ) ( 2,620 ) ( 25,503 )
Net cash used in operating activities ( 1,496,619 ) ( 1,298,723 ) ( 1,283,461 )
Cash flows from investing activities:
Purchases of property and equipment ( 325,434 ) ( 262,942 ) ( 117,508 )
Purchases of short-term investments ( 1,485 ) ( 2,147,881 ) ( 5,663,727 )
Proceeds from sale or maturity of short-term investments 1,563,618 3,146,891 2,751,075
Purchase of in-process research and development ( 143,665 ) ( 8,500 ) ( 109,500 )
Purchase of intangible assets 11 — ( 43,409 ) —
Purchase of long-term investments 6 ( 15,911 ) ( 43,500 ) ( 26,681 )
Other investing activities — — ( 2,025 )
Net cash provided by (used in) investing activities 1,077,123 640,659 ( 3,168,366 )
Cash flows from financing activities:
Proceeds from public offering, net of cost 19 — 3,392,616 —
Proceeds from sale of ordinary shares, net of cost 19 — 50,000 4,232,017
Proceeds from research and development cost share liability 4 — — 616,834
Payment to acquire joint venture (JV) minority interest 8 — — ( 28,723 )
Proceeds from long-term loan 14 37,372 16,838 110,208
Repayment of long-term loan 14 — — ( 132,061 )
Proceeds from short-term loans 14 313,774 406,449 323,697
Repayment of short-term loans 14 ( 417,081 ) ( 321,754 ) ( 12,247 )
Proceeds from option exercises and employee share purchase plan 46,964 92,762 93,101
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
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
Cash, cash equivalents, and restricted cash, end of year 3,875,037 4,382,887 1,390,005
Supplemental cash flow disclosures:
Cash and cash equivalents 3,869,564 4,375,678 1,381,950
Short-term restricted cash 196 328 307
Long-term restricted cash 5,277 6,881 7,748
Income taxes paid 29,500 15,695 10,596
Interest paid 25,169 29,967 44,130
Supplemental non-cash activities:
Accruals for capital expenditures 95,346 53,197 42,762
Purchase of in-process research and development included in accounts payable — 75,000 —
The accompanying notes are an integral part of these consolidated financial statements.
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BEIGENE, LTD.
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
Attributable to BeiGene, Ltd.
Ordinary Shares Additional
Paid-In
Capital Accumulated
Other
Comprehensive
Income/(Loss) Accumulated
Deficit Total Non-
Controlling
Interests
Shares Amount Total
$ $ $ $ $ $ $
Balance at December 31, 2019 801,340,698 79 2,925,970 ( 8,001 ) ( 1,993,737 ) 924,311 16,150 940,461
Proceeds from issuance of ordinary shares, net of cost 145,838,979 14 2,069,596 — — 2,069,610 — 2,069,610
Issuance of ordinary shares in connection with collaboration 206,635,013 21 2,162,386 — — 2,162,407 — 2,162,407
Exercise of options, ESPP and release of RSUs 38,020,892 3 93,098 — — 93,101 — 93,101
Use of shares reserved for share option exercises and RSU releases ( 1,013,641 ) 1 — — — 1 — 1
Share-based compensation — — 183,481 — — 183,481 — 183,481
Deconsolidation of a subsidiary — — — — — — ( 3,545 ) ( 3,545 )
Acquisition of joint venture (JV) minority interest — — ( 19,599 ) — — ( 19,599 ) ( 9,116 ) ( 28,715 )
Other comprehensive income — — — 14,943 — 14,943 128 15,071
Net loss — — — — ( 1,624,974 ) ( 1,624,974 ) ( 3,617 ) ( 1,628,591 )
Balance at December 31, 2020 1,190,821,941 118 7,414,932 6,942 ( 3,618,711 ) 3,803,281 — 3,803,281
Issuance of ordinary shares in connection with STAR Offering 115,055,260 12 3,392,604 — — 3,392,616 — 3,392,616
Proceeds from issuance of ordinary shares, net of cost 2,151,877 — 50,000 — — 50,000 — 50,000
Exercise of options, ESPP and release of RSUs 28,778,893 3 92,759 — — 92,762 — 92,762
Use of shares reserved for share option exercises ( 2,003,690 ) — — — — — — —
Share-based compensation — — 240,712 — — 240,712 — 240,712
Other comprehensive income — — — 11,008 — 11,008 11,008
Net loss — — — — ( 1,457,816 ) ( 1,457,816 ) — ( 1,457,816 )
Balance at December 31, 2021 1,334,804,281 133 11,191,007 17,950 ( 5,076,527 ) 6,132,563 — 6,132,563
Cost from issuance of ordinary shares — — ( 152 ) — — ( 152 ) — ( 152 )
Use of shares reserved for share option exercises 1,375,621 — — — — — — —
Exercise of options, ESPP and release of RSUs 19,960,278 2 46,962 — — 46,964 — 46,964
Share-based compensation — — 303,162 — — 303,162 — 303,162
Other comprehensive loss — — — ( 95,367 ) — ( 95,367 ) — ( 95,367 )
Net loss — — — — ( 2,003,815 ) ( 2,003,815 ) — ( 2,003,815 )
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.
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
1. Organization
BeiGene, Ltd. (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.
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. 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. Supported by its global clinical development and commercial capabilities, the Company has entered into collaborations with world-leading biopharmaceutical companies such as Amgen Inc. ("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. 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. 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.
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.
Since its inception in 2010, the Company has become a fully integrated global organization of over 9,000 employees in 29 countries and regions, including the United States, China, Europe and Australia.
2. Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (GAAP). The consolidated financial statements include the financial statements of the Company and its subsidiaries. All significant intercompany transactions and balances between the Company and its wholly-owned subsidiaries are eliminated upon consolidation.
Noncontrolling interests are recognized to reflect the portion of the equity of subsidiaries which are not attributable, directly or indirectly, to the controlling shareholders. Prior to 2020, the Company consolidated its interests in its joint ventures, BeiGene Biologics Co., Ltd. (BeiGene Biologics) and MapKure, LLC (MapKure), under the voting model and recognized the minority shareholders' equity interest as a noncontrolling interest in its consolidated financial statements. In June 2020, the Company deconsolidated MapKure and recorded an equity method investment for its remaining ownership interest in the joint venture (see Note 6). In November 2020, the Company acquired the remaining equity interest in BeiGene Biologics. Subsequent to the share purchase, BeiGene Biologics is a wholly owned subsidiary of the Company (see Note 8).
Use of Estimates
The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. 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
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
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. Actual results could differ from these estimates.
Functional Currency and Foreign Currency Translation
Functional currency
The Company uses the United States dollar ("$" or U.S. dollar) as its reporting currency. Operations in subsidiaries are recorded in the functional currency of the respective subsidiary. The determination of functional currency is based on the criteria of Accounting Standard Codification (ASC) 830, Foreign Currency Matters .
Foreign currency translation
For subsidiaries whose functional currencies are not the U.S. dollar, the Company uses the average exchange rate for the year and the exchange rate at the balance sheet date, to translate the operating results and financial position to U.S. dollar, the reporting currency, respectively. Translation differences are recorded in accumulated other comprehensive loss, a component of shareholders’ equity. Transactions denominated in currencies other than the functional currency are translated into the functional currency at the exchange rates prevailing on the transaction dates. Foreign currency denominated financial assets and liabilities are remeasured at the exchange rates prevailing at the balance sheet date. Remeasurement exchange gains and losses are included in the consolidated statements of operations.
Cash, Cash Equivalents and Restricted Cash
Cash and cash equivalents
Cash and cash equivalents consist of cash on hand and bank deposits, which are unrestricted as to withdrawal and use. The Company considers all highly liquid investments with an original maturity date of three months or less at the date of purchase to be cash equivalents. Cash equivalents which consist primarily of money market funds are stated at fair value.
Restricted cash
Restricted cash primarily consists of RMB-denominated cash deposits pledged in designated bank accounts as collateral for bank loans and letters of credit. The Company classifies restricted cash as current or non-current based on the term of the restriction.
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
Trade accounts receivable are recorded at their invoiced amounts, net of trade discounts and allowances as well as an allowance for credit losses. The allowance for credit losses reflects the Company's current estimate of credit losses expected to be incurred over the life of the receivables. The Company considers various factors in establishing, monitoring, and adjusting its allowance for credit losses including the aging of receivables and aging trends, customer creditworthiness and specific exposures related to particular customers. The Company also monitors other risk factors and forward-looking information, such as country specific risks and economic factors that may affect a customer's ability to pay in establishing and adjusting its allowance for credit losses. Accounts receivable are written off after all collection efforts have ceased.
Inventory
Prior to the regulatory approval of product candidates, the Company may incur expenses for the manufacture of drug product to support the commercial launch of those products. Until the date at which regulatory approval has been received or is otherwise considered probable, all such costs are recorded as research and development expenses as incurred.
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
Inventories are stated at the lower of cost and net realizable value, with cost determined in a manner that approximates the first-in, first-out method. The Company periodically analyzes its inventory levels, and writes down inventory that has become obsolete, inventory that has a cost basis in excess of its estimated realizable value and inventory in excess of expected sales requirements as cost of product sales. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded in the consolidated statements of operations.
Investments
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.
• Available-for-sale debt securities are stated at fair value, with the unrealized gains and losses, net of tax, reported in other comprehensive loss. The net carrying value of debt securities classified as available-for-sale is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization is computed using the effective interest method and included in interest income. Interest and dividends are included in interest income. Available-for-sale debt securities with original maturities greater than three months at the date of purchase and less than one year from the date of the balance sheet are classified as short-term. 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.
• Convertible note instruments are recorded using the fair value option method of accounting. 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. 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. 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. 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. 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. The Company deems an impairment to be other-than-temporary based on various factors, including but not limited to, the length of time the fair value is below the carrying value and ability to retain the investment to allow for a recovery in fair value.
Realized gains or losses on sales of investments are determined based on the specific identification method.
The Company regularly evaluates its investments in debt and equity for impairment. The Company recognizes an allowance on available-for-sale debt securities when a portion of the unrealized loss is attributable to a credit loss and a corresponding credit loss in net income. No impairment losses or allowance for credit losses on investments were recorded for any periods presented.
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
Property, Plant and Equipment
Property, plant and equipment are stated at cost, less accumulated depreciation and amortization. Property, plant and equipment, other than land and construction in progress, are depreciated using the straight-line method over the estimated useful lives of the respective assets as follows:
Useful Lives
Building 20 years
Manufacturing equipment 3 to 10 years
Laboratory Equipment 3 to 5 years
Software, Electronic and Office Equipment 3 to 5 years
Leasehold Improvements Lesser of useful life or lease term
Leases
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. The Company has lease agreements with lease and non-lease components, which are accounted for as a single lease component based on the Company’s policy election to combine lease and non-lease components for its leases. Leases are classified as operating or finance leases in accordance with the recognition criteria in ASC 842-20-25. The Company’s lease portfolio consists entirely of operating leases as of December 31, 2022. The Company’s leases do not contain any material residual value guarantees or material restrictive covenants.
At the commencement date of a lease, the Company determines the classification of the lease based on the relevant factors present and records a right-of-use (ROU) asset and lease liability. ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. ROU assets and lease liabilities are calculated as the present value of the lease payments not yet paid. Variable lease payments not dependent on an index or rate are excluded from the ROU asset and lease liability calculations and are recognized in expense in the period which the obligation for those payments is incurred. As the rate implicit in the Company’s leases is not typically readily available, the Company uses an incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. This incremental borrowing rate reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. ROU assets include any lease prepayments and are reduced by lease incentives. Operating lease expense for lease payments is recognized on a straight-line basis over the lease term. Lease terms are based on the non-cancelable term of the lease and may contain options to extend the lease when it is reasonably certain that the Company will exercise that option.
Operating leases are included in operating lease right-of-use assets and operating lease liabilities on the consolidated balance sheet. Lease liabilities that become due within one year of the balance sheet date are classified as current liabilities.
Leases with an initial lease term of 12 months or less are not recorded on the consolidated balance sheet. Lease expense for these leases is recognized on a straight-line basis over the lease term.
Land Use Right, Net
All land in the PRC is owned by the PRC government. The PRC government may sell land use rights for a specified period of time. Land use rights represent operating leases in accordance with ASC 842. The purchase price of land use rights represents lease prepayments to the PRC government and is recorded as an operating lease ROU asset on the balance sheet. The ROU asset is amortized over the remaining lease term.
In 2017, the Company acquired a land use right from the local Bureau of Land and Resources in Guangzhou for the purpose of constructing and operating the Company's biologics manufacturing facility in Guangzhou. In 2019, the Company acquired a second Guangzhou land use right from the local Bureau of Land and Resources. In 2021, the Company acquired two land use rights from the local Bureau of Land and Resources to expand its biologics manufacturing facility in Guangzhou. Guangzhou land use rights are being amortized over the respective terms of the land use rights, which are each 50 years.
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
In 2018, the Company acquired a land use right in conjunction with the acquisition of Beijing Innerway Bio-tech Co., Ltd. The land use right is being amortized over the term of the land use right, which is 36 years.
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. In 2022, the Company acquired a second Suzhou land use right from the local Bureau of Land and Resources. 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
Goodwill is an asset representing the future economic benefits arising from other assets acquired in a business combination that are not individually identified and separately recognized. The Company allocates the cost of an acquired entity to the assets acquired and liabilities assumed based on their estimated fair values at the date of acquisition. The excess of the purchase price for acquisitions over the fair value of the net assets acquired, including other intangible assets, is recorded as goodwill. Goodwill is not amortized, but is tested for impairment at least annually or more frequently if events or changes in circumstances would indicate a potential impairment.
The Company has elected to first assess qualitative factors to determine whether it is more likely than not that the fair value of the Company's reporting unit is less than its carrying amount, including goodwill. The qualitative assessment includes the Company's evaluation of relevant events and circumstances affecting the Company's single reporting unit, including macroeconomic, industry, and market conditions, the Company's overall financial performance, and trends in the market price of the Company's ADSs. If qualitative factors indicate that it is more likely than not that the Company's reporting unit’s fair value is less than its carrying amount, then the Company will perform the quantitative impairment test by comparing the reporting unit’s carrying amount, including goodwill, to its fair value. If the carrying amount of the reporting unit exceeds its fair value, an impairment loss will be recognized in an amount equal to that excess. For the years ended December 31, 2022, 2021 and 2020 the Company determined that there were no indicators of impairment of goodwill.
Intangible assets acquired through business combinations are recognized as assets separate from goodwill and are measured at fair value upon acquisition. Intangible assets acquired in transactions that are not business combinations are recorded at the allocated portion of total consideration transferred based on their relative fair value in relation to net assets acquired. Intangible assets associated with milestone payments made to third parties subsequent to regulatory approval are recorded at cost. Identifiable intangible assets consist of distribution rights for approved cancer therapies licensed from BMS that are amortized on a straight-line basis over the estimated useful lives of the assets, which is 10 years; post-approval milestone payments under license and commercialization agreements, that are amortized over the remainder of the product patent or the term of the commercialization agreements; and trading licenses that are amortized over the initial license term.
Intangible assets with finite useful lives are tested for impairment when events or circumstances occur that could indicate that the carrying amount of an asset may not be recoverable. When these events occur, the Company evaluates the recoverability of the intangible assets by comparing the carrying amount of the assets to the future undiscounted cash flows expected to result from the use of the assets and their eventual disposition. If the sum of the expected undiscounted cash flows is less than the carrying amount of the assets, the Company recognizes an impairment loss based on the excess of the carrying amount of the assets over their fair value. Fair value is generally determined by discounting the cash flows expected to be generated by the assets, when the market prices are not readily available. For the years ended December 31, 2022, 2021 and 2020, the Company determined that there were no indicators of impairment of its other intangible assets.
Impairment of Long-Lived Assets
Long-lived assets are reviewed for impairment in accordance with authoritative guidance for impairment or disposal of long-lived assets. Long-lived assets are reviewed for events or changes in circumstances, which indicate that their carrying value may not be recoverable. Long-lived assets are reported at the lower of carrying amount or fair value less cost to sell. For the years ended December 31, 2022, 2021 and 2020, there was no impairment of the value of the Company’s long-lived assets.
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
Fair Value Measurements
Fair value of financial instruments
The Company applies ASC topic 820 (ASC 820), Fair Value Measurements and Disclosures, in measuring fair value. ASC 820 defines fair value, establishes a framework for measuring fair value and requires disclosures to be provided on fair value measurement. ASC 820 establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level 1 — Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level 2 — Include other inputs that are directly or indirectly observable in the marketplace.
Level 3 — Unobservable inputs which are supported by little or no market activity.
ASC 820 describes three main approaches to measuring the fair value of assets and liabilities: (1) market approach; (2) income approach; and (3) cost approach. The market approach uses prices and other relevant information generated from market transactions involving identical or comparable assets or liabilities. The income approach uses valuation techniques to convert future amounts to a single present value amount. The measurement is based on the value indicated by current market expectations about those future amounts. The cost approach is based on the amount that would currently be required to replace an asset.
Financial instruments measured at fair value on a recurring basis
The following tables set forth assets measured at fair value on a recurring basis as of December 31, 2022 and 2021:
As of December 31, 2022 Quoted Price
in Active
Market for
Identical
Assets
(Level 1) Significant
Other
Observable
Inputs
(Level 2) Significant
Unobservable
Inputs
(Level 3)
$ $ $
Cash equivalents:
Money market funds 758,114 — —
Short-term investments (Note 6):
U.S. treasury securities 665,251 — —
Other non-current assets (Note 6):
Equity securities with readily determinable fair values 3,307 706 —
Convertible debt instrument — — 3,000
Prepaid expenses and other current assets (Note 6):
Convertible debt instrument — — 5,190
Total 1,426,672 706 8,190
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
As of December 31, 2021 Quoted Price
in Active
Market for
Identical
Assets
(Level 1) Significant
Other
Observable
Inputs
(Level 2) Significant
Unobservable
Inputs
(Level 3)
$ $ $
Cash equivalents
U.S. treasury securities 107,855 — —
Money market funds 315,564 — —
Short-term investments (Note 6):
U.S. treasury securities 2,241,962 — —
Other non-current assets (Note 6):
Equity securities with readily determinable fair values 23,809 10,306 —
Total 2,689,190 10,306 —
The Company's cash equivalents are highly liquid investments with original maturities of 3 months or less. Short-term investments represent the Company's investments in available-for-sale debt securities. The Company determines the fair value of cash equivalents and available-for-sale debt securities using a market approach based on quoted prices in active markets.
The Company's equity securities carried at fair value consist of holdings in common stock and warrants to purchase additional shares of common stock of Leap Therapeutics, Inc. (Leap), which were acquired in connection with a collaboration and license agreement entered into in January 2020 and in Leap's underwritten public offering in September 2021. The common stock investment in Leap, a publicly-traded biotechnology company, is measured and carried at fair value and classified as Level 1. The warrants to purchase additional shares of common stock in Leap are classified as a Level 2 investment and are measured using the Black-Scholes option-pricing valuation model, which utilizes a constant maturity risk-free rate and reflects the term of the warrants, dividend yield and stock price volatility, that is based on the historical volatility of similar companies. 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.
The Company holds convertible notes issued by two private biotech companies. The Company has elected the fair value option method of accounting for the convertible notes. 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. Long-term debt approximates its fair value due to the fact that the related interest rates approximate the rates currently offered by financial institutions for similar debt instrument of comparable maturities.
Revenue Recognition
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. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer.
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. The
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
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
The Company generates product revenues in China through the sale of its internally developed drugs tislelizumab, BRUKINSA and pamiparib, and the sale of in-licensed products through its agreements with Amgen, BMS, Bio-Thera and EUSA Pharma. Under the commercial profit share arrangement with Amgen, the Company is the principal for in-licensed product sales to customers in China during the commercialization period and recognizes 100% of net product revenue on these sales. Amounts due to Amgen for its portion of net product sales are recorded as cost of sales. In the United States, the Company generates product revenues from the sale of BRUKINSA.
In China, the Company sells its internally developed products to multiple distributors, who in turn sell the product to hospitals or pharmacies within their authorized territories to be sold ultimately to patients. In-licensed products are sold to a first tier distributor who subsequently resells the products to second tier distributors who ultimately sell the products to health care providers and patients. In the United States, the Company distributes BRUKINSA through specialty pharmacies and specialty distributors. The specialty pharmacies and specialty distributors subsequently resell the product to health care providers and patients.
The Company is the principal under the product sales as the Company controls the products with the ability to direct the use of, and obtain substantially all the remaining benefits from the products before they are sold to the customer. For product sales transactions, the Company has a single performance obligation which is to sell the products to its customer. The Company includes variable consideration in the transaction price to the extent it is probable that a significant reversal will not occur and estimates variable consideration from rebates, chargebacks, trade discounts and allowances, sales returns allowances and other incentives using the expected value method. Revenues for product sales are recognized at a point in time when the single performance obligation is satisfied upon delivery to the customer. The Company's payment terms are approximately 45-90 days. Actual amounts of consideration ultimately received may differ from the Company’s estimates. The Company will reassess estimates for variable consideration periodically. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.
Estimates for variable consideration for which reserves are established at the time of sale include government and commercial rebates, provisions for acceptance of National Reimbursement Drug List pricing in the PRC, chargebacks, trade discounts and allowances, sales returns allowances and other incentives that are offered within contracts between the Company and its customers, health care providers and other indirect customers. Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, channel inventory levels, specific known market events and trends, industry data and forecasted customer buying and payment patterns.
The Company bases its sales returns allowance on estimated distributor inventories, customer demand as reported by third-party sources, and actual returns history, as well as other factors, as appropriate. For newly launched products where actual returns history is not yet available, the sales returns allowance is initially calculated based on benchmarking data from similar products and industry experience. If the historical or benchmarking data the Company uses to calculate these estimates do not properly reflect future returns, then a change in the allowance would be made in the period in which such a determination is made and revenues in that period could be materially affected. Any changes from the historical trend rates are considered in determining the current sales return allowance. To date, sales returns have not been significant.
Collaboration Revenue
At contract inception, the Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (ASC 808) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. 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. For elements of
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
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.
The Company’s collaborative arrangements may contain more than one unit of account, or performance obligation, including grants of licenses to intellectual property rights, agreement to provide research and development services and other deliverables. The collaborative arrangements do not include a right of return for any deliverable. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. In developing the stand-alone selling price for a performance obligation, the Company considers competitor pricing for a similar or identical product, market awareness of and perception of the product, expected product life and current market trends. In general, the consideration allocated to each performance obligation is recognized when the respective obligation is satisfied either by delivering a good or providing a service, limited to the consideration that is not constrained. Non-refundable payments received before all of the relevant criteria for revenue recognition are satisfied are recorded as advances from customers.
Licenses of Intellectual Property: Upfront non-refundable payments for licensing the Company’s intellectual property are evaluated to determine if the license is distinct from the other performance obligations identified in the arrangement. For licenses determined to be distinct, the Company recognizes revenues from non-refundable up-front fees allocated to the license at a point in time, when the license is transferred to the licensee and the licensee is able to use and benefit from the license.
Options to License Intellectual Property: Upfront non-refundable payments for options to license the Company’s intellectual property are evaluated to determine if the option represents a material right and is distinct from the other performance obligations identified in the arrangement. For options determined to be a material right and distinct, the Company defers the non-refundable up-front fees allocated to the option and recognizes revenues at a point in time, at the earlier of when the option is exercised or the option period expires.
Right to Access Intellectual Property during the Option Period: The portion of a transaction price allocated to the other parties right to access the Company's intellectual property to generate their own data during an option period is deferred and recognized as collaboration revenue over the option period on a straight-line basis as the right to use the intellectual property is provided and the data generated.
Research and Development Services: The portion of a transaction price allocated to research and development services performance obligations is deferred and recognized as collaboration revenue over time as delivery or performance of such services occurs.
Milestone Payments: At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestones related to the Company’s development-based activities may include initiation of various phases of clinical trials. Due to the uncertainty involved in meeting these development-based targets, they are generally fully constrained at contract inception. The Company will assess whether the variable consideration is fully constrained each reporting period based on the facts and circumstances surrounding the clinical trials. Upon changes to constraint associated with the developmental milestones, variable consideration will be included in the transaction price when a significant reversal of revenue recognized is not expected to occur and allocated to the separate performance obligations. Regulatory milestones are fully constrained until the period in which those regulatory approvals are achieved due to the inherent uncertainty with the approval process. Regulatory milestones are included in the transaction price in the period regulatory approval is obtained.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
Research and Development Expenses
Research and development expenses consist of the costs associated with our research and development activities, conducting preclinical studies and clinical trials, and activities related to regulatory filings, which primarily include (i) payroll and related costs (including share-based compensation) associated with research and development personnel, (ii) costs related to clinical trials and preclinical testing of the Company’s technologies under development, (iii) costs to develop the product candidates, including raw materials and supplies, product testing, depreciation, and facility related expenses, (iv) expenses for research services provided by universities and contract laboratories, including sponsored research funding, and (v) other research and development expenses. Research and development expenses are charged to expense as incurred when these expenditures relate to the Company’s research and development services and have no alternative future uses.
Clinical trial costs are a significant component of the Company’s research and development expenses. The Company has a history of contracting with third parties that perform various clinical trial activities on behalf of the Company in the ongoing development of the Company’s product candidates. Expenses related to clinical trials are accrued based on the Company’s estimates of the actual services performed by the third parties for the respective period. If the contracted amounts are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), the Company will modify the related accruals accordingly on a prospective basis. Revisions in the scope of a contract are charged to expense in the period in which the facts that give rise to the revision become reasonably certain.
The process of estimating the Company's research and development expenses involves reviewing open contracts and purchase orders, communicating with its personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated costs incurred for the services when the Company has not yet been invoiced or otherwise notified of the actual costs. The majority of the Company's service providers invoice it in arrears for services performed, on a pre‑determined schedule or when contractual milestones are met; however, some require advanced payments. The Company makes estimates of the expenses as of each balance sheet date in its financial statements based on facts and circumstances known to the Company at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting expenses that are too high or too low in any particular period. There were no material adjustments for a change in estimate to research and development expenses in the accompanying consolidated financial statements for the years ended December 31, 2022, 2021 and 2020.
Acquired In-Process Research and Development Expense
The Company has acquired rights to develop and commercialize product candidates. Upfront payments that relate to the acquisition of a new drug compound, as well as pre-commercial milestone payments, are immediately expensed as acquired in-process research and development in the period in which they are incurred, provided that the new drug compound did not also include processes or activities that would constitute a “business” as defined under GAAP, the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no established alternative future use. Milestone payments made to third parties subsequent to regulatory approval are capitalized as intangible assets and amortized over the estimated remaining useful life of the related product. Royalties owed on sales of the products licensed pursuant to the agreements are expensed in the period the related revenues are recognized.
Government Grants
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.
The Company received government assistance in the form of cash primarily to support the Guangzhou manufacturing facility build-out and research and development programs. 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. 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. For the year ended December 31, 2022, depreciation expense is presented net of amortization of government assistance of $ 3,169 .
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
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. As of December 31, 2022 and 2021, other long-term liabilities related to research and development programs totaled $ 58 and $ 1,759 , respectively. 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.
Comprehensive Loss
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. 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. 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
Awards granted to employees
The Company applies ASC 718, Compensation—Stock Compensation (ASC 718), to account for its employee share-based payments. In accordance with ASC 718, the Company determines whether an award should be classified and accounted for as a liability award or equity award. All the Company’s grants of share-based awards to employees were classified as equity awards and are recognized in the financial statements based on their grant date fair values. Specifically, the grant date fair value of share options is calculated using an option pricing model. The fair value of restricted shares and restricted share units are based on the closing market price of our ADSs on the NASDAQ Global Select Market on the date of grant. The Company has elected to recognize compensation expense using the straight-line method for all employee equity awards granted with graded vesting based on service conditions provided that the amount of compensation cost recognized at any date is at least equal to the portion of the grant-date value of the options that are vested at that date. The Company uses the accelerated method for all awards granted with graded vesting based on performance conditions. To the extent the required vesting conditions are not met resulting in the forfeiture of the share-based awards, previously recognized compensation expense relating to those awards are reversed. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in the subsequent period if actual forfeitures differ from initial estimates.
Forfeiture rates are estimated based on historical and future expectations of employee turnover rates and are adjusted to reflect future changes in circumstances and facts, if any. Share-based compensation expense is recorded net of estimated forfeitures such that expense is recorded only for those share-based awards that are expected to vest. To the extent the Company revises these estimates in the future, the share-based payments could be materially impacted in the period of revision, as well as in following periods. The Company, with the assistance of an independent third-party valuation firm, determined the estimated fair value of the stock options granted to employees using the binomial option pricing model.
Awards granted to non-employees
The Company has accounted for equity instruments issued to non-employees in accordance with the provisions of ASC 718 and ASC 505, Equity . All transactions in which goods or services are received in exchange for equity instruments are accounted for based on the fair value of the consideration received or the fair value of the equity instrument issued, whichever is more reliably measurable. The grant date is the measurement date of the fair value of the equity instrument issued. The expense is recognized in the same manner as if the Company had paid cash for the services provided by the non-employees in accordance with ASC 505-50, Equity-based payments to non-employees . The Company estimated the fair value of share options granted to non-employees using the same method as employees.
Modification of awards
A change in any of the terms or conditions of the awards is accounted for as a modification of the award. 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. For vested awards, the Company recognizes incremental compensation cost in the period the
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
modification occurs. 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. 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.
Income Taxes
The Company uses the liability method of accounting for income taxes. 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. 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. The Company recognizes in the financial statements the benefit of a tax position which is “more likely than not” to be sustained under examination based solely on the technical merits of the position assuming a review by tax authorities having all relevant information. Tax positions that meet the recognition threshold are measured using a cumulative probability approach, at the largest amount of tax benefit that has a greater than fifty percent likelihood of being realized upon settlement. It is the Company’s policy to recognize interest and penalties related to unrecognized tax benefits, if any, as a component of income tax expense.
Loss Per Share
Loss per share is calculated in accordance with ASC 260, Earnings per Share . Basic loss per ordinary share is computed by dividing net loss attributable to ordinary shareholders by the weighted average number of ordinary shares outstanding during the period using the two-class method. Under the two-class method, net income is allocated between ordinary shares and participating securities based on dividends declared (or accumulated) and participating rights in undistributed earnings as if all the earnings for the reporting period had been distributed. The Company’s restricted shares are participating securities because they have contractual rights to share in the profits of the Company.
However, the restricted shares do not have contractual rights and obligations to share in the losses of the Company. For the periods presented herein, the computation of basic loss per share using the two-class method is not applicable as the Company is in a net loss position.
Diluted loss per share is calculated by dividing net loss attributable to ordinary shareholders as adjusted for the effect of dilutive ordinary equivalent shares, if any, by the weighted average number of ordinary and dilutive ordinary equivalent shares outstanding during the period. Ordinary equivalent shares consist of the ordinary shares issuable upon the conversion of the Company’s convertible preferred shares, if any, using the if-converted method, and ordinary shares issuable upon the conversion of the share options and unvested restricted shares, using the treasury stock method.
Ordinary share equivalents are excluded from the computation of diluted loss per share if their effects would be anti-dilutive. Basic and diluted loss per ordinary share is presented in the Company’s consolidated statements of operations.
Segment Information
In accordance with ASC 280, Segment Reporting , the Company’s chief operating decision maker, the Chief Executive Officer, reviews the consolidated results when making decisions about allocating resources and assessing performance of the Company as a whole and hence, the Company has only one reportable segment: pharmaceutical products.
Concentration of Risks
Concentration of credit risk
Financial instruments that are potentially subject to credit risk consist of cash and cash equivalents, short-term investments, and accounts receivable.
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. The deposits placed with
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
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. Management believes that these financial institutions are of high credit quality and continually monitors the credit worthiness of these financial institutions. As of December 31, 2022 and 2021, the Company had short-term investments amounting to $ 665,251 and $ 2,241,962 , respectively.
At December 31, 2022 and 2021, the Company’s short-term investments were comprised of U.S. treasury securities. The Company believes that U.S. treasury securities are of high credit quality and continually monitors the credit worthiness of these institutions.
As of December 31, 2022 and 2021, the Company had accounts receivable, net of $ 173,168 and $ 483,113 , respectively. 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
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. 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. For the year ended December 31, 2021, the Company's collaboration revenue consisted entirely of revenue recognized under its out-licensing collaboration agreements with Novartis. Receivables from Novartis represented approximately 66.4 % of trade accounts receivable as of December 31, 2021, primarily due to the invoicing of the $ 300,000 upfront fee related to the Ociperlimab option, collaboration and license agreement.
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.
Business, customer, political, social and economic risks
The Company participates in a dynamic biopharmaceutical industry and believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial position, results of operations, or cash flows: changes in the overall demand for services and products; competitive pressures due to existing competitors and new entrants; advances and new trends in new drugs and industry standards; changes in clinical research organizations, contract manufacturers and other key vendors; changes in certain strategic relationships or customer relationships; regulatory considerations; intellectual property considerations; and risks associated with the Company’s ability to attract and retain employees necessary to support its growth. The Company’s operations could be also adversely affected by significant political, economic and social uncertainties in the PRC and in relations between the PRC and United States.
Currency convertibility risk
A significant portion of the Company’s expenses, assets and liabilities are denominated in RMB. 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. dollar or other foreign currencies. All foreign exchange transactions continue to take place either through the PBOC or other banks authorized to buy and sell foreign currencies at the exchange rates quoted by the PBOC. Approvals of foreign currency payments by the PBOC or other institutions require submitting a payment application form together with suppliers’ invoices, shipping documents and signed contracts.
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.
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
Foreign currency exchange rate risk
The Company is exposed to foreign exchange risk arising from various currency exposures. The Company's reporting currency is the U.S. dollar, but a portion of its operating transactions and assets and liabilities are in other currencies, such as RMB, Euro, and Australian dollar. 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.
RMB is not freely convertible into foreign currencies for capital account transactions. The value of RMB against the U.S. 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. 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. government policy may impact the exchange rate between the RMB and the U.S. dollar in the future.
To the extent that the Company needs to convert U.S. dollar into RMB for capital expenditures and working capital and other business purposes, appreciation of RMB against U.S. dollar would have an adverse effect on the RMB amount the Company would receive from the conversion. Conversely, if the Company decides to convert RMB into U.S. dollar for the purpose of making payments for dividends on ordinary shares, strategic acquisitions or investments or other business purposes, appreciation of U.S. dollar against RMB would have a negative effect on the U.S. dollar amount available to the Company.
In addition, a significant depreciation of the RMB against the U.S. dollar may significantly reduce the U.S. dollar equivalent of the Company's foreign cash balances and trade receivables. Further, volatility in exchange rate fluctuations may have a significant impact on the foreign currency translation adjustments recorded in other comprehensive income (loss). The revaluation impact of foreign currencies held in U.S. functional currency subsidiaries may result in significant foreign exchange gains (losses) in the consolidated statement of operations. The Company has not used derivative financial instruments to hedge exposure to foreign exchange risk.
Revision of prior period financial statements
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. 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. 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.
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. Accordingly, no valuation allowance was previously recorded related to those deferred tax assets. 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. The Company determined the previous conclusion to not apply a valuation allowance to certain net deferred tax assets was an error.
In accordance with Staff Accounting Bulletin (SAB) No. 99, “Materiality,” and SAB No. 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. 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. A summary of revisions to previously reported financial statements is presented in Note 3, Revision of Prior Period Financial Statements. Note 12, Income Taxes and Note 16, Loss Per Share have been updated to
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
reflect the revision. 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
In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance. This update requires certain annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy. This update is effective for annual periods beginning after December 15, 2021, and early application is permitted. 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. The Company adopted this standard on January 1, 2022. The adoption of this standard has been applied to existing government assistance transactions.
3. Revision of Prior Period Financial Statements
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). Specifically, a valuation allowance should have been recorded on all net deferred tax assets and such a valuation allowance was not previously recorded. 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.
Consolidated Balance Sheet
As of
December 31, 2021
As Reported Adjustments As Revised
$ $ $
Deferred tax assets 110,424 ( 110,424 ) —
Total non-current assets 1,032,069 ( 110,424 ) 921,645
Total assets 8,645,949 ( 110,424 ) 8,535,525
Accumulated deficit ( 4,966,103 ) ( 110,424 ) ( 5,076,527 )
Total equity 6,242,987 ( 110,424 ) 6,132,563
Total liabilities and equity 8,645,949 ( 110,424 ) 8,535,525
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
Consolidated Statements of Operations
Year Ended December 31, Year Ended December 31,
2021 2020
As Reported Adjustments As Revised As Reported Adjustments As Revised
$ $ $ $ $ $
Income tax expense (benefit) ( 25,234 ) 44,462 19,228 ( 17,671 ) 28,068 10,397
Net loss ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,600,523 ) ( 28,068 ) ( 1,628,591 )
Net loss attributable to BeiGene, Ltd. ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,596,906 ) ( 28,068 ) ( 1,624,974 )
Net loss per share attributable to BeiGene, Ltd., basic and diluted ( 1.17 ) ( 0.04 ) ( 1.21 ) ( 1.47 ) ( 0.03 ) ( 1.50 )
Net loss per American Depositary Share ("ADS") ( 15.23 ) ( 0.48 ) ( 15.71 ) ( 19.13 ) ( 0.34 ) ( 19.47 )
Consolidated Statements of Comprehensive Loss
Year Ended December 31, Year Ended December 31,
2021 2020
As Reported Adjustments As Revised As Reported Adjustments As Revised
$ $ $ $ $ $
Net loss ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,600,523 ) ( 28,068 ) ( 1,628,591 )
Comprehensive loss ( 1,402,346 ) ( 44,462 ) ( 1,446,808 ) ( 1,585,452 ) ( 28,068 ) ( 1,613,520 )
Comprehensive loss attributable to BeiGene, Ltd. ( 1,402,346 ) ( 44,462 ) ( 1,446,808 ) ( 1,581,963 ) ( 28,068 ) ( 1,610,031 )
Consolidated Statement of Cash Flows
Year Ended December 31, Year Ended December 31,
2021 2020
As Reported Adjustments As Revised As Reported Adjustments As Revised
$ $ $ $ $ $
Operating activities:
Net loss ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,600,523 ) ( 28,068 ) ( 1,628,591 )
Adjustments to reconcile net loss to net cash used in operating activities:
Deferred income tax expense ( 41,085 ) 44,462 3,377 ( 27,807 ) 28,068 261
Net cash used in operating activities ( 1,298,723 ) — ( 1,298,723 ) ( 1,283,461 ) — ( 1,283,461 )
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
Consolidated Statement of Stockholders' Equity
Accumulated Deficit Total Equity
As Reported Adjustments As Revised As Reported Adjustments As Revised
$ $ $ $ $ $
Balance at December 31, 2019 ( 1,955,843 ) ( 37,894 ) ( 1,993,737 ) 978,355 ( 37,894 ) 940,461
Net loss ( 1,596,906 ) ( 28,068 ) ( 1,624,974 ) ( 1,600,523 ) ( 28,068 ) ( 1,628,591 )
Balance at December 31, 2020 ( 3,552,749 ) ( 65,962 ) ( 3,618,711 ) 3,869,243 ( 65,962 ) 3,803,281
Net loss ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,413,354 ) ( 44,462 ) ( 1,457,816 )
Balance at December 31, 2021 ( 4,966,103 ) ( 110,424 ) ( 5,076,527 ) 6,242,987 ( 110,424 ) 6,132,563
4. Collaborative and Licensing Arrangements
The Company enters into collaborative arrangements for the research and development, manufacture and/or commercialization of drug products and drug candidates. To date, these collaborative arrangements have included out-licenses of and options to out-license internally developed products and drug candidates to other parties, in-licenses of products and drug candidates from other parties, and profit- and cost-sharing arrangements. These arrangements may include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost-sharing and reimbursement arrangements, royalty payments, and profit sharing.
Out-Licensing Arrangements
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:
Year Ended December 31,
2022 2021 2020
Revenue from Collaborators $ $ $
License revenue — 484,646 —
Research and development service revenue 46,822 53,671 —
Right to access intellectual property revenue 104,994 3,979 —
Other 9,493 — —
Total 161,309 542,296 —
Novartis
Tislelizumab Collaboration and License
In January 2021, the Company entered into a collaboration and license agreement with Novartis, granting Novartis rights to develop, manufacture and commercialize tislelizumab in North America, Europe, and Japan (the "Novartis Territory"). The Company and Novartis have agreed to jointly develop tislelizumab in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals. In addition, both companies may conduct clinical trials globally to explore combinations of tislelizumab with other cancer treatments, and the Company has an option to co-detail the product in North America, funded in part by Novartis.
Under the agreement the Company received an upfront cash payment of $ 650,000 from Novartis. 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. 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
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
combination with its own or third party products. Each party retains the worldwide right to commercialize its propriety products in combination with tislelizumab.
The Company evaluated the Novartis agreement under ASC 606 as all the material units of account within the agreement represented transactions with a customer. The Company identified the following material components under the agreement: (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; (2) conducting and completing ongoing trials of tislelizumab (R&D services); and (3) supplying Novartis with required quantities of the tislelizumab drug product, or drug substance, upon receipt of an order from Novartis.
The Company determined that the license, transfer of know-how and use of trademarks are not distinct from each other and represent a single performance obligation. The R&D services represent a material promise and were determined to be a separate performance obligation at the outset of the agreement as the promise is distinct and has standalone value to Novartis. The Company evaluated the supply component of the contract and noted the supply will not be provided at a significant incremental discount to Novartis. The Company concluded that, for the purpose of ASC 606, the provision related to providing clinical and commercial supply of tislelizumab in the Novartis Territory was an option but not a performance obligation of the Company at the outset of the Novartis collaboration agreement. A performance obligation for the clinical and commercial supply will be established as quantities of drug product or drug substance are ordered by Novartis.
The Company determined that the transaction price as of the outset of the arrangement was the upfront payment of $ 650,000 . The potential milestone payments that the Company is eligible to receive were excluded from the transaction price, as all milestone amounts were fully constrained due to uncertainty of achievement. The transaction price was allocated to the two identified performance obligations based on a relative fair value basis. The standalone selling price of the license, transfer of know-how and use of trademarks performance obligation was determined using the adjusted market assessment approach based on the probability-weighted present value of forecasted cash flows associated with out-licensing tislelizumab in the Novartis Territory. The standalone selling price of the R&D services was valued using a cost plus margin valuation approach based on the present value of estimated tislelizumab clinical trial costs plus a reasonable margin. Based on the relative standalone selling prices of the two performance obligations, $ 484,646 of the total transaction price was allocated to the license and $ 165,354 was allocated to the R&D services. The estimates of the standalone selling prices involved management's key assumptions such as revenue growth rate, estimated clinical trial costs, mark-up rate, probability of technical and regulatory success, and discount rates. These significant assumptions are forward looking and could be affected by future economic, regulatory and market conditions.
The Company satisfied the license performance obligation at a point in time when the license was delivered and the transfer of know-how completed which occurred during the year ended December 31, 2021. As such, the Company recognized the entire amount of the transaction price allocated to the license as collaboration revenue during the year ended December 31, 2021. The portion of the transaction price allocated to the R&D services was deferred and is being recognized as collaboration revenue as the R&D services are performed using a percentage-of-completion method. Estimated costs to complete are reassessed on a periodic basis and any updates to the revenue earned are recognized on a prospective basis. The Company recognized R&D service revenue of $ 39,655 and $ 53,421 during the years ended December 31, 2022 and 2021, respectively. 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.
Ociperlimab Option, Collaboration and License Agreement and China Broad Market Development Agreement
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. 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.
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. Following option
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
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. Following the option exercise, Novartis has agreed to share development costs of global trials. Following approval, the Company has agreed to provide 50 percent of the co-detailing and co-field medical efforts in the United States, and has an option to co-detail up to 25 percent in Canada and Mexico, funded in part by Novartis. Each party retains the worldwide right to commercialize its propriety products in combination with ociperlimab, as is the case with tislelizumab under the tislelizumab collaboration and license agreement. The existing tislelizumab collaboration and license agreement was not modified as a result of the ociperlimab option, collaboration and license agreement.
The Company evaluated the Novartis agreements under ASC 606 as the units of account within the agreement represented transactions with a customer. The Company identified the following material promises under the agreement: (1) exclusive option for Novartis to license the rights develop, manufacture, and commercialize ociperlimab in the Novartis Territory; (2) Novartis' right to access ociperlimab in its own clinical trials during the option period; (3) initial transfer of BeiGene know-how; and (4) conducting and completing ongoing trials of ociperlimab during the option period (R&D Services). The market development activities are considered immaterial in the context of the contracts.
The Company concluded that, at the inception of the agreement, the option for the exclusive product license constitutes a material right as it represents a significant and incremental discount to the fair value of the exclusive product license that Novartis would not have received without entering into the agreement and is therefore considered a distinct performance obligation. The Company determined that Novartis' right to access ociperlimab in its own trials over the option period and the initial transfer of know-how were not distinct from each other, as the right to access ociperlimab has limited value without the corresponding know-how transfer, and therefore should be combined into one distinct performance obligation. The R&D Services represent a material promise and were determined to be a separate performance obligation at the outset of the agreement as the promise is distinct and has standalone value to Novartis.
The Company determined the transaction price as of the outset of the arrangement was the upfront payment of $ 300,000 . The option exercise fee is contingent upon Novartis exercising its right and is considered fully constrained until the option is exercised. Additionally, the milestone and royalty payments are not applicable until after the option is exercised, at which point the likelihood of meeting milestones, regulatory approval and meeting certain sales thresholds will be assessed. T he transaction price was allocated to the three identified performance obligations based on a relative fair value basis. The standalone selling price of the material right for the option to the exclusive product license was calculated as the incremental discount between (i) the value of the license determined using a discounted cash flow method adjusted for probability of the option being exercised and (ii) the expected option exercise fee using the most-likely-amount method at option exercise. The standalone selling price of the combined performance obligation for Novartis' right to access ociperlimab for its own clinical trials during the option period and the initial transfer of BeiGene know-how was determined using a discounted cash flow method. The standalone selling price of the R&D Services was determined using an expected cost plus margin approach. Based on the relative standalone selling prices of the three performance obligations, $ 71,980 of the total transaction price was allocated to the material right, $ 213,450 was allocated to Novartis' right to use ociperlimab in its own clinical trials during the option period and the transfer of BeiGene know-how, and $ 14,570 was allocated to the R&D Services.
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. 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. 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.
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
In-Licensing Arrangements - Commercial
Amgen
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.
Under the agreement, the Company is responsible for the commercialization of XGEVA, KYPROLIS and BLINCYTO in China for five or seven years . Amgen is responsible for manufacturing the products globally and will supply the products to the Company at an agreed upon price. The Company and Amgen will share equally in the China commercial profits and losses during the commercialization period. Following the commercialization period, the Company has the right to retain one product and is entitled to receive royalties on sales in China for an additional five years on the products not retained. XGEVA was approved in China in 2019 for patients with giant cell tumor of the bone and in November 2020 for the prevention of skeletal-related events in cancer patients with bone metastases. In July 2020, the Company began commercializing XGEVA in China. In December 2020, BLINCYTO was approved in China for injection for the treatment of adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL). 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. 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. The Company is responsible for conducting clinical development activities in China and co-funding global development costs by contributing cash and development services up to a total cap of $ 1,250,000 . Amgen is responsible for all development, regulatory and commercial activities outside of China. For each pipeline asset that is approved in China, the Company will receive commercial rights for seven years from approval. The Company has the right to retain approximately one out of every three approved pipeline assets, other than 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. The Company is also entitled to receive royalties from global sales of each product outside of China (with the exception of AMG 510). 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. 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. 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; 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. The Company is the principal for product sales to customers in China during the commercialization period and will recognize 100 % of net product revenue on these sales. Amounts due to Amgen for its portion of net product sales will be recorded as cost of sales. Cost reimbursements due to or from Amgen under the profit share will be recognized as incurred and recorded to cost of sales; selling, general and administrative expense; or research and development expense, based on the underlying nature of the related activity subject to reimbursement. Costs incurred for the Company's portion of the global co-development funding are recorded to research and development expense as incurred.
In connection with the Amgen Collaboration Agreement, a Share Purchase Agreement (SPA) was entered into by the parties on October 31, 2019. On January 2, 2020, the closing date of the transaction, Amgen purchased 15,895,001 of the Company's ADSs for $ 174.85 per ADS, representing a 20.5 % ownership stake in the Company. Per the SPA, the cash proceeds shall be used as necessary to fund the Company's development obligations under the Amgen Collaboration Agreement. Pursuant to the SPA, Amgen also received the right to designate one member of the Company's board of directors, and Anthony
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
Hooper joined the Company's board of directors as the Amgen designee in January 2020. Amgen relinquished its right to appoint a designated director to the Company's board of directors in January 2023.
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. The fair value of the shares on the closing date was determined to be $ 132.74 per ADS, or $ 2,109,902 in the aggregate. The Company determined that the premium paid by Amgen on the share purchase represents a cost share liability due to the Company's co-development obligations. The fair value of the cost share liability on the closing date was determined to be $ 601,857 based on the Company's discounted estimated future cash flows related to the pipeline assets. The estimation of future cash flows involved management assumptions of revenue growth rates and probability of technical and regulatory success of the pipeline assets. The total cash proceeds of $ 2,779,241 were allocated based on the relative fair value method, with $ 2,162,407 recorded to equity and $ 616,834 recorded as a research and development cost share liability. The cost share liability is being amortized proportionately as the Company contributes cash and development services to its total co-development funding cap.
Amounts recorded related to the cash proceeds received from the Amgen collaboration for the year ended December 31, 2020 were as follows:
Year Ended December 31, 2020
$
Fair value of equity issued to Amgen 2,162,407
Fair value of research and development cost share liability 616,834
Total cash proceeds 2,779,241
Amounts recorded related to the Company's portion of the co-development funding on the pipeline assets for the years ended December 31, 2022, 2021 and 2020 were as follows:
Year Ended December 31,
2022 2021 2020
$ $ $
Research and development expense 98,955 115,464 117,005
Amortization of research and development cost share liability 96,402 112,486 113,986
Total amount due to Amgen for BeiGene's portion of the development funding 195,357 227,950 230,991
As of December 31, 2022
Remaining portion of development funding cap 595,702
As of December 31, 2022 and 2021, the research and development cost share liability recorded in the Company's balance sheet was as follows:
As of December 31,
2022 2021
$ $
Research and development cost share liability, current portion 114,335 120,801
Research and development cost share liability, non-current portion 179,625 269,561
Total research and development cost share liability 293,960 390,362
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
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,
2022 2021 2020
$ $ $
Cost of sales - product 5,898 1,893 ( 1,210 )
Selling, general and administrative ( 54,865 ) ( 45,152 ) ( 9,750 )
Research and development ( 1,216 ) 423 ( 660 )
Total ( 50,183 ) ( 42,836 ) ( 11,620 )
The Company purchases commercial inventory from Amgen to distribute in China. Total inventory purchases amounted to $ 71,720 , $ 110,303 and 38,392 , respectively, during the year ended December 31, 2022, 2021 and 2020 . Net amounts payable to Amgen as of December 31, 2022 and 2021 were $ 54,064 and $ 106,790 , respectively.
In-Licensing Arrangements - Development
The Company has in-licensed the rights to develop, manufacture and, if approved, commercialize multiple development stage drug candidates globally or in specific territories. These arrangements typically include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost-sharing arrangements, royalty payments, and profit sharing.
Upfront and milestone payments made under these arrangements for the years ended December 31, 2022, 2021 and 2020 are set forth below. All upfront and development milestones were expensed to research and development expense. All regulatory and commercial milestones were capitalized as intangible assets and are being amortized over the remainder of the respective product patent or the term of the commercialization agreements.
Year Ended December 31,
2022 2021 2020
Payments due to collaboration partners Classification $ $ $
Upfront payments Research and development expense 68,665 83,500 109,500
Development milestone payments Research and development expense 5,500 15,000 15,800
Regulatory and commercial milestone payments Intangible asset — 43,394 —
Total 74,165 141,894 125,300
Our significant license agreements are described below:
Shandong Luye Pharmaceutical Co., Ltd.
In December 2022, the Company entered into an exclusive license agreement with Shandong Luye Pharmaceutical Co., Ltd. ("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. 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. Luye is also eligible to receive future milestone payments upon achievement of certain regulatory milestones. Luye is also eligible to receive tiered royalties on net sales. Luye is considered a related party due to a significant common shareholder. That shareholder has different representatives serving on each companies' respective board of directors.
Shoreline Biosciences, Inc.
In June 2021, the Company entered into an exclusive worldwide strategic collaboration with Shoreline Biosciences, Inc. (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. Under the collaboration, the Company and Shoreline are working jointly to develop cell therapies for four
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
designated therapeutic targets, with an option to expand the collaboration at a future date. Clinical development is being led by the Company globally, with Shoreline responsible for clinical manufacturing. The Company has commercial rights globally, with Shoreline having an option to retain commercialization rights in the United States and Canada for two targets. 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. 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.
Nanjing Leads Biolabs, Inc.
In December 2021, the Company entered into a license and collaboration agreement with Nanjing Leads Biolabs, Inc. (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. Leads Biolabs is also eligible to receive tiered royalties on future sales in the licensed territory. 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.
EUSA Pharma
In January 2020, the Company entered into an exclusive development and commercialization agreement with EUSA Pharma (EUSA) for the orphan biologic products SYLVANT ® (siltuximab) and QARZIBA ® (dinutuximab beta) in China. Under the terms of the agreement, EUSA granted the Company exclusive rights to SYLVANT in greater China and to QARZIBA in mainland China. Under the agreement, the Company is funding and undertaking all clinical development and regulatory submissions in the territories, and commercializing both products once approved. EUSA received a $ 40,000 upfront payment upon contract execution and is eligible to receive additional payments upon the achievement of regulatory and commercial milestones up to a total of $ 120,000 . The upfront payment was expensed to research and development expense during the year ended December 31, 2020 in accordance with the Company's acquired in-process research and development expense policy. In 2021, QARZIBA and SYLVANT were approved and launched in mainland China and greater China, respectively. The approvals triggered regulatory milestone payments that were capitalized as intangible assets and are being amortized over the remaining term of the license agreement. EUSA is receiving tiered royalties on SYLVANT product sales, which the Company records as cost of sales in the period the respective sales are generated.
Assembly Biosciences, Inc.
In July 2020, the Company entered into a collaboration agreement with Assembly Biosciences, Inc. (Assembly) for Assembly's portfolio of three clinical-stage core inhibitor candidates for the treatment of patients with chronic hepatitis B virus (HBV) infection in China. Under the terms of the agreement, Assembly granted BeiGene exclusive rights to develop and commercialize ABI-H0731, ABI-H2158 and ABI-H3733 in China, including Hong Kong, Macau, and Taiwan. BeiGene is responsible for development, regulatory submissions, and commercialization in China. Assembly retains full worldwide rights outside of the partnered territory for its HBV portfolio. Assembly received an upfront payment of $ 40,000 and is eligible to receive payments upon achievement of development, regulatory and commercial milestones up to a total of $ 503,750 . Assembly is also eligible to receive tiered royalties on net sales. The upfront payment was expensed to research and development expense during the year ended December 31, 2020 in accordance with the Company's acquired in-process research and development expense policy.
Bio-Thera Solutions, Ltd.
In August 2020, the Company entered into a license, distribution and supply agreement with Bio-Thera Solutions, Ltd. (Bio-Thera) for Bio-Thera's POBEVCY ® (BAT1706), a biosimilar to Avastin ® (bevacizumab) in China. The agreement became effective on September 10, 2020 upon approval of Bio-Thera's shareholders, and was subsequently assigned by the Company to its affiliate BeiGene (Guangzhou) Co., Ltd. (BeiGene Guangzhou) on September 18, 2020, as permitted by the agreement. Under the terms of the agreement, Bio-Thera agreed to grant BeiGene the right to develop, manufacture, and commercialize POBEVCY in China, including Hong Kong, Macau, and Taiwan. Bio-Thera retained rights outside of the partnered territory. Bio-Thera received an upfront payment of $ 20,000 in October 2020 and is eligible to receive payments upon the achievement of regulatory and commercial milestones up to a total of $ 145,000 . The upfront payment was expensed to research and
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
development expense during the year ended December 31, 2020 in accordance with the Company's acquired in-process research and development expense policy. 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. 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.
Other
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. The Company may be required to pay additional amounts upon the achievement of various development and commercial milestones under these agreements. The Company may also incur significant research and development costs if the related product candidate were to advance to late-stage clinical trials. In addition, if any products related to these collaborations are approved for sale, the Company may be required to pay significant milestones upon approval and milestones and/or royalties on future sales. The payment of these amounts, however, is contingent upon the occurrence of various future events, which have a high degree of uncertainty of occurrence.
5. Restricted Cash
The Company’s restricted cash balance of $ 5,473 and $ 7,209 as of December 31, 2022 and 2021, respectively, primarily consist of RMB-denominated cash deposits held in designated bank accounts for collateral for letters of credit. The Company classifies restricted cash as current or non-current based on term of restriction.
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.
6. Investments
Short-Term Investments
Short-term investments as of December 31, 2022 consisted of the following available-for-sale debt securities:
Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair Value
(Net Carrying
Amount)
$ $ $ $
U.S. treasury securities 674,262 — 9,011 665,251
Total 674,262 — 9,011 665,251
Short-term investments as of December 31, 2021 consisted of the following available-for-sale debt securities:
Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair Value
(Net Carrying
Amount)
$ $ $ $
U.S. treasury securities 2,245,662 — 3,700 2,241,962
Total 2,245,662 — 3,700 2,241,962
The Company does not consider the investments in U.S. treasury securities to be other-than-temporarily impaired at December 31, 2022. As of December 31, 2022, the Company's available-for-sale debt securities consisted entirely of short-term U.S. treasury securities, which were determined to have zero risk of expected credit loss. Accordingly, no allowance for credit loss was recorded as of December 31, 2022.
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
Equity Securities with Readily Determinable Fair Values
Leap Therapeutics, Inc. (Leap)
In January 2020, the Company purchased $ 5,000 of Series B mandatorily convertible, non-voting preferred stock of Leap in connection with a strategic collaboration and license agreement the Company entered into with Leap. The Series B shares were subsequently converted into shares of Leap common stock and warrants to purchase additional shares of common stock upon approval of Leap's shareholders in March 2020. In September 2021, the Company purchased $ 7,250 of common stock in Leap's underwritten public offering. As of December 31, 2022, the Company's ownership interest in the outstanding common stock of Leap was 7.4 % based on information from Leap. Inclusive of the shares of common stock issuable upon the exercise of the currently exercisable warrants, the Company's interest is approximately 11.7 %. 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. 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:
As of December 31,
2022 2021
$ $
Fair value of Leap common stock 3,307 23,809
Fair value of Leap warrants 706 10,306
Private Equity Securities without Readily Determinable Fair Values
The Company invests in equity securities of certain companies whose securities are not publicly traded and fair value is not readily determinable and where the Company has concluded it does not have significant influence based on its ownership percentage and other factors. 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. 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. 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. There were no adjustments to the carrying values of these securities for the years ended December 31, 2021 and 2020.
Equity-Method Investments
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. 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. 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.
7. Inventories
The Company’s inventory balance consisted of the following:
As of December 31,
2022 2021
$ $
Raw materials 88,957 78,140
Work in process 20,886 9,397
Finished goods 172,503 155,089
Total inventories 282,346 242,626
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
8. Manufacturing Facility in Guangzhou, China
Manufacturing legal entity structure
BeiGene Shanghai, originally established as a wholly-owned subsidiary of BeiGene (Hong Kong) Co., Ltd. (BeiGene HK), and currently a wholly-owned subsidiary of BeiGene Biologics, as described below, provides clinical development services for BeiGene affiliates and is the clinical trial authorization (CTA) holder and marketing authorization application (MAA) holder for tislelizumab in China.
In March 2017, BeiGene HK, a wholly owned subsidiary of the Company, and Guangzhou GET Technology Development Co., Ltd. (now Guangzhou High-tech Zone Technology Holding Group Co., Ltd.) (GET), entered into a definitive agreement to establish a commercial scale biologics manufacturing facility in Guangzhou, Guangdong Province, PRC. BeiGene HK and GET entered into an Equity Joint Venture Contract (the “JV Agreement”).
Under the terms of the JV Agreement, BeiGene HK made an initial cash capital contribution of RMB 200,000 and a subsequent contribution of one or more biologics assets in exchange for a 95 % equity interest in BeiGene Biologics. GET made a cash capital contribution of RMB 100,000 to BeiGene Biologics, representing a 5 % equity interest in BeiGene Biologics. In addition, on March 7, 2017, BeiGene Biologics entered into a contract with GET, under which GET agreed to provide a RMB 900,000 loan (the "Shareholder Loan”) to BeiGene Biologics. In September 2019, BeiGene Biologics completed the first phase of construction of a biologics manufacturing facility in Guangzhou, through a wholly owned subsidiary, the BeiGene Guangzhou Biologics Manufacturing Co., Ltd. (BeiGene Guangzhou Factory), to manufacture biologics for the Company and its subsidiaries.
BeiGene HK and BeiGene Biologics subsequently entered into an Equity Transfer Agreement to transfer 100 % of the equity interest of BeiGene Shanghai to BeiGene Biologics, as required by the JV agreement, such that the CTA holder and MAA holder for tislelizumab in China was controlled by BeiGene Biologics. Upon the transfer of equity in BeiGene Shanghai, BeiGene HK's equity interest in BeiGene Shanghai became 95 %.
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. The share purchase was recorded as an equity transaction. The carrying amount of the noncontrolling interest balance of $ 9,116 was adjusted to nil to reflect the increase in BeiGene HK’s ownership interest to 100 %, and the difference in the fair value of the consideration paid and the carrying amount of the noncontrolling interest of $ 19,599 was recorded to additional paid in capital. In connection with the JV Share Purchase Agreement, BeiGene Biologics repaid the outstanding principal of the Shareholder Loan of $ 132,061 (RMB 900,000 ) and accrued interest of $ 36,558 (RMB 249,140 ).
In connection with the JV share purchase, the Company entered into a loan agreement with China Minsheng Bank for a total loan facility of up to $ 200,000 (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. In October 2020, the Company drew down $ 80,000 of the working capital facility and $ 118,320 of the acquisition facility to be used for the JV share repurchase. On October 9, 2021, the Company repaid $ 198,320 and drew down $ 200,000 from the Senior Loan . 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. 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. See Note 14 for further discussion of the loans.
9. Leases
The Company has operating leases for office and manufacturing facilities in the United States, Switzerland, and China. The leases have remaining lease terms of up to five years , some of which include options to extend the leases that have not been included in the calculation of the Company’s lease liabilities and ROU assets. 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. The land use rights represent lease prepayments and are expensed over the remaining term of
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
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. 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:
Year Ended December 31,
2022 2021 2020
$ $ $
Operating lease cost 25,938 22,536 18,271
Variable lease cost 6,834 4,892 2,465
Short-term lease cost 1,299 1,823 1,018
Total lease cost 34,071 29,251 21,754
Supplemental balance sheet information related to leases was as follows:
As of December 31,
2022 2021
$ $
Operating lease right-of-use assets 56,008 60,762
Land use rights, net 53,952 56,669
Total operating lease right-of-use assets 109,960 117,431
Current portion of operating lease liabilities 24,041 21,925
Operating lease liabilities, non-current portion 34,517 43,041
Total lease liabilities 58,558 64,966
Maturities of operating lease liabilities are as follows:
$
Year ending December 31, 2023 26,278
Year ending December 31, 2024 21,647
Year ending December 31, 2025 11,312
Year ending December 31, 2026 2,821
Year ending December 31, 2027 966
Total lease payments 63,024
Less imputed interest ( 4,466 )
Present value of lease liabilities 58,558
Other supplemental information related to leases is summarized below:
Year ended December 31,
2022 2021 2020
$ $ $
Operating cash flows used in operating leases 28,064 19,962 17,571
ROU assets obtained in exchange for new operating lease liabilities 22,278 37,454 17,634
As of December 31,
2022 2021
Weighted-average remaining lease term (years) 3 3
Weighted-average discount rate 5.76 % 5.15 %
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
10. Property, Plant and Equipment, Net
Property, plant and equipment, net are recorded at cost less accumulated depreciation and consisted of the following:
As of December 31,
2022 2021
$ $
Land 65,485 65,485
Laboratory equipment 158,908 118,203
Leasehold improvements 53,786 50,288
Building 222,448 144,083
Manufacturing equipment 175,679 119,585
Software, electronics and office equipment 47,483 27,404
Property and equipment, at cost 723,789 525,048
Less: Accumulated depreciation ( 171,470 ) ( 124,286 )
Construction in progress 293,627 186,843
Property, plant and equipment, net 845,946 587,605
In November 2021, the Company purchased a 42 -acre site located in Hopewell, NJ for $ 75,197 . The total purchase price was allocated between the land and an existing building on the property based on their relative fair values. The Company is constructing a biologics manufacturing facility and research and development center on the land.
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:
As of December 31,
2022 2021
$ $
Building 224,392 90,229
Manufacturing equipment 33,332 63,361
Laboratory equipment 12,256 17,178
Other 23,647 16,075
Total 293,627 186,843
Depreciation expense for the years ended December 31, 2022, 2021 and 2020 were $ 62,302 , $ 44,742 and $ 30,943 , respectively.
11. Intangible Assets
Intangible assets as of December 31, 2022 and December 31, 2021 are summarized as follows:
December 31, 2022 December 31, 2021
Gross
carrying
amount Accumulated
amortization Intangible
assets, net Gross
carrying
amount Accumulated
amortization Intangible
assets, net
$ $ $ $ $ $
Finite-lived intangible assets:
Product distribution rights 7,500 ( 4,000 ) 3,500 7,500 ( 3,250 ) 4,250
Developed products 41,235 ( 4,119 ) 37,116 43,394 ( 965 ) 42,429
Trading license 816 ( 816 ) — 816 ( 816 ) —
Total finite-lived intangible assets 49,551 ( 8,935 ) 40,616 51,710 ( 5,031 ) 46,679
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
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. 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. 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. Trading license represents the Guangzhou drug distribution license acquired in September 2018. The Company amortized the drug distribution trading license over the remainder of the initial license term through February 2020. The trading license has been renewed through February 2024.
Amortization expense for developed products is included in cost of sales - product in the accompanying consolidated statements of operations. Amortization expense for product distribution rights and trading licenses is included in operating expenses in the accompanying consolidated statements of operations. The weighted-average life for each finite-lived intangible assets is approximately 12 years. Amortization expense is as follows:
Year Ended December 31,
2022 2021 2020
$ $ $
Amortization expense - Cost of sales - product
3,225 965 —
Amortization expense - Operating expense
751 750 846
Total 3,976 1,715 846
Estimated amortization expense for each of the five succeeding years and thereafter, as of December 31, 2022 is as follows:
Year Ending December 31, Cost of Sales - Product Operating Expenses Total
$ $ $
2023
3,170 750 3,920
2024 3,170 750 3,920
2025 3,170 750 3,920
2026 3,170 750 3,920
2027 3,170 500 3,670
2028 and thereafter 21,266 — 21,266
Total 37,116 3,500 40,616
12. Income Taxes
The components of income ( loss) before income taxes are as follows:
Year Ended December 31,
2022 2021 2020
$ $ $
PRC ( 583,610 ) ( 606,752 ) ( 369,066 )
U.S. 67,744 34,923 33,608
Other ( 1,445,171 ) ( 866,759 ) ( 1,282,736 )
Total ( 1,961,037 ) ( 1,438,588 ) ( 1,618,194 )
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
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:
Year Ended December 31,
2022 2021 2020
$ $ $
Current Tax Expense (Benefit):
PRC 27,905 15,252 16,121
U.S. 4,844 ( 9 ) ( 5,678 )
Other 6,547 805 68
Total 39,296 16,048 10,511
Deferred Tax Expense (Benefit):
PRC 3,480 4,919 ( 114 )
U.S. — ( 35 ) —
Other 2 ( 1,704 ) —
Total 3,482 3,180 ( 114 )
Income Tax (Benefit) Expense 42,778 19,228 10,397
The reconciliation of the statutory tax rate to our effective income tax rate is as follow:
Year Ended December 31,
2022 2021 2020
$ $ $
Loss before tax ( 1,961,037 ) ( 1,438,588 ) ( 1,618,194 )
China statutory tax rate 25 % 25 % 25 %
Expected taxation at China statutory tax rate ( 490,259 ) ( 359,647 ) ( 404,549 )
Foreign and preferential tax rate differential 288,133 185,874 218,473
Non-deductible expenses 30,598 ( 2,826 ) 8,436
Stock compensation expenses 33,872 ( 27,411 ) ( 22,032 )
Effect of tax rate change — — ( 3,827 )
Change in valuation allowance 229,550 254,768 237,153
Research tax credits and incentives ( 49,116 ) ( 31,530 ) ( 23,257 )
Taxation for the year 42,778 19,228 10,397
Effective tax rate ( 2.2 ) % ( 1.3 ) % ( 0.6 ) %
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
Significant components of deferred tax assets (liabilities) are as follows:
Year Ended December 31,
2022 2021 2020
$ $ $
Deferred tax assets (liabilities):
Accruals and reserves 97,896 84,766 33,512
Net operating losses carryforward 862,214 625,114 358,425
Stock-based compensation 19,700 14,982 13,981
Research tax credits 86,000 82,060 58,835
Depreciable and amortizable assets 798,563 937,069 724,779
Lease liability obligation 10,348 11,571 9,066
R&D and other capitalized costs 63,156 — —
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 )
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. After consideration of all positive and negative evidence, the Company believes that as of December 31, 2022, it is more likely than not that certain deferred tax assets will not be realized for our subsidiaries in Australia, Switzerland, the United States, and for certain subsidiaries in China. For the years ended December 31, 2022 and 2021 , there were increases in the valuation allowance of $ 229,550 and $ 254,768 , respectively. Adjustments may be required in the future if the Company estimates that the amount of deferred tax assets to be realized is more or less than the net amount recorded.
As of December 31, 2022 and 2021 , the Company had net operating losses of approximately $ 5,077,247 and $ 3,644,981 , respectively. As of December 31, 2022, net operating losses were primarily comprised of: $ 1,633,101 from entities in the PRC which expire in years 2024 through 2032; $ 3,397,529 derived from Switzerland which expires in years 2025 through 2029; and, $ 26,079 derived from entities in the United States that have an indefinite carryforward. The Company has approximately $ 108,861 of U.S. research tax credits which will expire between 2036 and 2042, if not utilized.
The gross unrecognized tax benefits for the years ended December 31, 2022, 2021 and 2020 were as follows:
Year Ended December 31,
2022 2021 2020
$ $ $
Beginning balance, as of January 1 9,925 7,123 4,633
Additions based on tax positions related to prior tax years — — —
Reductions based on tax positions related to prior tax years — — —
Additions based on tax positions related to the current tax year 1,630 2,802 2,497
Reductions based on lapse of statute of limitations — — ( 7 )
Ending balance, as of December 31 11,555 9,925 7,123
Current and prior year additions include an assessment of U.S. federal and state tax credits and incentives. 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. The Company does not anticipate that the amount of existing unrecognized tax benefits will significantly change within the next 12 months.
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
The Company has elected to record interest and penalties related to income taxes as a component of income tax expense. For the years ended December 31, 2022, 2021 and 2020, the Company's accrued interest and penalties, where applicable, related to uncertain tax positions were not material.
The Company conducts business in a number of tax jurisdictions and, as such, is required to file income tax returns in multiple jurisdictions globally. As of December 31, 2022, Australia tax matters are open to examination for the years 2013 through 2022, China tax matters are open to examination for the years 2012 through 2022, Switzerland tax matters are open to examination for the years 2018 through 2022, and U.S. federal tax matters are open to examination for years 2015 through 2022. Various U.S. states and other non-US tax jurisdictions in which the Company files tax returns remain open to examination for 2012 through 2022.
The Company qualifies for the Technology Advanced Service Enterprises (TASE) and High and New Technology Enterprise (HNTE) status for certain subsidiaries in China, which expire at the end of 2025. 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.
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. A deferred tax liability has not been established for the approximately $ 2,379 of cumulative undistributed foreign earnings. Determination of the unrecognized deferred tax liability is not practicable due to the uncertainty and overall complexity of the hypothetical calculation.
13. Supplemental Balance Sheet Information
Changes in the allowance for credit losses related to trade accounts receivable consist of the following:
Year Ended December 31,
2022 2021 2020
$ $
Beginning balance, as of January 1 415 112 —
Provision charged to selling, general and administrative expenses ( 219 ) 309 109
Amounts written-off, net of recoveries of amounts previously reserved 1 — —
Exchange rate changes 14 ( 6 ) 3
Ending balance, as of December 31 211 415 112
Prepaid expenses and other current assets consist of the following:
As of December 31,
2022 2021
$ $
Prepaid research and development costs 71,488 87,239
Prepaid taxes 20,478 58,579
Other receivables 22,777 12,010
Interest receivable 3,039 5,052
Prepaid insurance 3,664 1,695
Prepaid manufacturing cost 58,950 78,538
Short-term deposit 1,510 2,982
Other current assets 34,647 24,078
Total 216,553 270,173
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
Other non-current assets consist of the following:
As of December 31,
2022 2021
$ $
Goodwill 109 109
Prepayment of property and equipment 22,025 14,140
Prepaid supply cost (1) 48,642 24,237
Prepaid VAT 804 17,162
Rental deposits and other 7,054 6,609
Long-term investments 91,779 100,792
Total 170,413 163,049
(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.
Accrued expenses and other payables consisted of the following:
As of December 31,
2022 2021
$ $
Compensation related 184,775 139,966
External research and development activities related 139,168 213,922
Commercial activities 51,806 71,560
Individual income tax and other taxes 18,815 45,661
Sales rebates and returns related 41,817 59,639
Other 30,971 27,307
Total accrued expenses and other payables 467,352 558,055
Other long-term liabilities consist of the following:
As of December 31,
2022 2021
$ $
Deferred government grant income 38,176 46,352
Pension liability 7,760 7,814
Other 159 68
Total other long-term liabilities 46,095 54,234
14. Debt
The following table summarizes the Company's short-term and long-term debt obligations as of December 31, 2022 and 2021:
Lender Agreement Date Line of Credit Term Maturity Date Interest Rate As of December 31,
2022 2021
$ RMB $ RMB
China Construction Bank April 4, 2018 RMB 580,000 9 -year
April 4, 2027 (1) 7,250 50,000 1,255 8,000
China Merchants Bank January 22, 2020 (2) 9 -year
January 20, 2029 (2) 1,450 10,000 1,569 10,000
China Merchants Bank November 9, 2020 RMB 378,000 9 -year
November 8, 2029 (3) 5,437 37,500 — —
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
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
Shanghai Pudong Development Bank February 25, 2022 $ 50,000 1 -year
February 25, 2023 2.2 % 50,000 344,851 — —
Other short-term debt (6) 114,832 792,000 209,048 1,332,197
Total short-term debt 328,969 2,268,905 427,565 2,724,732
China Construction Bank April 4, 2018 RMB 580,000 9 -year
April 4, 2027 (1) 75,395 520,000 89,444 570,000
China Merchants Bank January 22, 2020 (2) 9 -year
January 20, 2029 (2) 49,369 340,500 53,353 340,000
China Merchants Bank November 9, 2020 RMB 378,000 9 -year
November 8, 2029 (3) 47,847 330,000 59,316 378,000
China CITIC Bank July 29, 2022 RMB 480,000 10 -year
July 28, 2032 (7) 36,537 252,000 — —
Total long-term debt 209,148 1,442,500 202,113 1,288,000
1. The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC. The loan interest rate was 4.7 % as of December 31, 2022. The Company repaid $ 1,171 (or RMB 8,000 ) during the year ended December 31, 2022 . 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.
2. 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. In connection with the Company's short-term loan agreements with China Merchants Bank entered into during the year ended December 31, 2020, the borrowing capacity was reduced from RMB 1,100,000 to RMB 350,000 . The loan interest rate was 4.4 % as of December 31, 2022. The Company repaid $ 1,484 (RMB 10,000 ) during the year ended December 31, 2022 . BeiGene Guangzhou Biologics Manufacturing Co., Ltd. is a company incorporated under the laws of the PRC on March 3, 2017 and a wholly owned subsidiary of BeiGene Biologics.
3. The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC. The loan interest rate was 4.0 % as of December 31, 2022. 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.
4. 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. The Company may extend the original maturity date for up to two additional twelve month periods. 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. 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.
5. 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: (i) November 9, 2021, which is one month after the Senior Loan maturity date, if not extended, or (ii) 10 business days after the Senior Loan is fully repaid. On October 8, 2021, the Company extended the maturity date of the Related Party Loan to the earlier of: (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. 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.
6. 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. The Company repaid $ 200,446 (RMB 1,332,197 ) of the short-term loans during the year ended. December 31, 2022. The weighted average interest rate for the short-term working capital loans was approximately 2.6 % as of December 31, 2022.
7. 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 . 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.
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
Contractual Maturities of Debt Obligations
The aggregate contractual maturities of all borrowings due subsequent to December 31, 2022 are as follows:
Maturity dates Amounts
$
Year ending December 31, 2023 328,969
Year ending December 31, 2024 29,412
Year ending December 31, 2025 35,136
Year ending December 31, 2026 44,697
Year ending December 31, 2027 44,697
Thereafter 55,206
Total 538,117
Interest Expense
Interest on bank loans and the Related Party Loan is paid quarterly until the respective loans are fully settled. Interest expense recognized for the years ended December 31, 2022, 2021 and 2020 amounted to $ 21,699 , $ 29,263 and $ 18,309 , respectively, among which, $ 2,594 , $ 1,054 and $ 338 was capitalized, respectively.
15. Product Revenue
The Company’s product revenue is primarily derived from the sale of its internally developed products BRUKINSA in the United States and China, and tislelizumab and pamiparib in China; REVLIMID ® and VIDAZA ® in China under a license from BMS; XGEVA, BLINCYTO and KYPROLIS in China under a license from Amgen; 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.
Year Ended December 31,
2022 2021 2020
$ $ $
Product revenue - gross 1,438,440 748,824 324,672
Less: Rebates and sales returns ( 183,828 ) ( 114,837 ) ( 15,798 )
Product revenue - net 1,254,612 633,987 308,874
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
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.
Year Ended December 31,
2022 2021 2020
$ $ $
BRUKINSA ®
564,651 217,987 41,702
Tislelizumab 422,885 255,119 163,358
REVLIMID ®
79,049 70,065 47,372
XGEVA ®
63,398 45,956 8,496
POBEVCY ®
38,124 1,353 —
BLINCYTO ®
36,107 12,515 —
KYPROLIS ®
13,696 — —
VIDAZA ®
15,213 19,591 29,975
Pamiparib 5,460 3,661 —
ABRAXANE ®
— — 17,770
Other 16,029 7,740 201
Total product revenue - net 1,254,612 633,987 308,874
The following table presents the roll-forward of accrued sales rebates and returns for the years ended December 31, 2022 and December 31, 2021.
Year Ended December 31,
2022 2021
$ $
Beginning balance, as of January 1 59,639 11,874
Accrual 183,828 114,837
Payment ( 201,650 ) ( 67,072 )
Ending balance, as of December 31 41,817 59,639
16. Loss Per Share
Loss per share was calculated as follows:
Year Ended December 31,
2022 2021 2020
$ $ $
Numerator:
Net loss ( 2,003,815 ) ( 1,457,816 ) ( 1,628,591 )
Less: Net loss attributable to noncontrolling interest — — ( 3,617 )
Net loss attributable to BeiGene, Ltd. ( 2,003,815 ) ( 1,457,816 ) ( 1,624,974 )
Denominator:
Weighted average shares outstanding for computing basic and diluted loss per share 1,340,729,572 1,206,210,049 1,085,131,783
Net loss per share attributable to BeiGene, Ltd., basic and diluted ( 1.49 ) ( 1.21 ) ( 1.50 )
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.
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
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.
17. Share-Based Compensation
2016 Share Option and Incentive Plan
In January 2016, in connection with its U.S. IPO, the board of directors and shareholders of the Company approved the 2016 Share Option and Incentive Plan (the “2016 Plan”), which became effective in February 2016. The Company initially reserved 65,029,595 ordinary shares for the issuance of awards under the 2016 Plan, plus any shares available under the 2011 Option Plan (the “2011 Plan”), and not subject to any outstanding options as of the effective date of the 2016 Plan, along with underlying share awards under the 2011 Plan that are cancelled or forfeited without issuance of ordinary shares. As of December 31, 2022, ordinary shares cancelled or forfeited under the 2011 Plan that were carried over to the 2016 Plan totaled 5,166,653 . The 2016 Plan provided for an annual increase in the shares available for issuance, to be added on the first day of each fiscal year, beginning on January 1, 2017, equal to the lesser of (i) five percent ( 5 )% of the outstanding shares of the Company's ordinary shares on the last day of the immediately preceding fiscal year or (ii) such number of shares determined by the Company’s board of directors or the compensation committee. On January 1, 2018, 29,603,616 ordinary shares were added to the 2016 Plan under this provision. However, in August 2018, in connection with the Hong Kong IPO, the board of directors of the Company approved an amended and restated 2016 Plan to remove this "evergreen" provision and implement other changes required by the Hong Kong Stock Exchange (HKEx) rules. In December 2018, the shareholders of the Company approved a second amended and restated 2016 Plan to increase the number of shares authorized for issuance by 38,553,159 ordinary shares, as well as amend the cap on annual compensation to independent directors and make other changes. In June 2020, the shareholders approved an Amendment No. 1 to the 2016 Plan to increase the number of shares authorized for issuance by 57,200,000 ordinary shares and to extend the term of the plan through April 13, 2030. The number of shares available for issuance under the 2016 Plan is subject to adjustment in the event of a share split, share dividend or other change in the Company’s capitalization.
As of December 31, 2022, share-based awards to acquire 75,034,504 ordinary shares were available for future grant under the 2016 Plan.
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. 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
In June 2018, the board of directors of the Company approved the 2018 Inducement Equity Plan (the “2018 Plan”) and reserved 12,000,000 ordinary shares to be used exclusively for grants of awards to individuals who were not previously employees of the Company or its subsidiaries, as a material inducement to the individual’s entry into employment with the Company or its subsidiaries, within the meaning of Rule 5635(c)(4) of the NASDAQ Listing Rules. The 2018 Plan was approved by the board of directors upon recommendation of the compensation committee, without shareholder approval pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules. The terms and conditions of the 2018 Plan, and the forms of award agreements to be used thereunder, are substantially similar to the 2016 Plan and the forms of award agreements thereunder. 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.
Upon the effectiveness of Amendment No. 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
In June 2018, the shareholders of the Company approved the 2018 Employee Share Purchase Plan (the ESPP). Initially, 3,500,000 ordinary shares of the Company were reserved for issuance under the ESPP. 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
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
the HKEx rules. In December 2018, the shareholders of the Company approved a second amended and restated ESPP to increase the number of shares authorized for issuance by 3,855,315 ordinary shares to 7,355,315 ordinary shares. The ESPP allows eligible employees to purchase the Company’s ordinary shares (including in the form of ADSs) at the end of each offering period, which will generally be six months , at a 15 % discount to the market price of the Company’s ADSs at the beginning or the end of each offering period, whichever is lower, using funds deducted from their payroll during the offering period. Eligible employees are able to authorize payroll deductions of up to 10 % of their eligible earnings, subject to applicable limitations.
The following tables summarizes the shares issued under the ESPP:
Market Price 1
Purchase Price 2
Issuance Date Number of Ordinary Shares Issued ADS Ordinary ADS Ordinary Proceeds
August 31, 2022 861,315 $ 171.66 $ 13.20 $ 145.91 $ 11.22 $ 9,667
February 28, 2022 667,160 $ 210.52 $ 16.19 $ 178.94 $ 13.76 $ 9,183
August 31, 2021 425,386 $ 308.30 $ 23.72 $ 262.06 $ 20.16 $ 8,575
February 26, 2021 436,124 $ 236.30 $ 18.18 $ 200.86 $ 15.45 $ 6,738
August 31, 2020 485,069 $ 164.06 $ 12.62 $ 139.45 $ 10.73 $ 5,203
February 28, 2020 425,425 $ 145.54 $ 11.20 $ 123.71 $ 9.52 $ 4,048
1 The market price is the lower of the closing price on the NASDAQ Stock Market on the issuance date or the offering date, in accordance with the terms of the ESPP.
2 The purchase price is the price which was discounted from the applicable market price, in accordance with the terms of the ESPP.
As of December 31, 2022, 3,666,071 ordinary shares were available for future issuance under the ESPP.
Share options
Generally, share options have a contractual term of 10 years and vest over a three - to five-year period, with the first tranche vesting one calendar year after the grant date or the service relationship start date and the remainder of the awards vesting on a monthly basis thereafter. 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.
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
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:
Number of
Options Weighted
Average
Exercise
Price Weighted
Average
Grant
Date Fair
Value Weighted
Average
Remaining
Contractual
Term Aggregate
Intrinsic Value
$ $ Years $
Outstanding at December 31, 2019 108,417,254 3.96
Granted 8,999,536 13.54 7.15
Exercised ( 29,707,587 ) 2.82 416,509
Forfeited ( 2,717,488 ) 7.22
Outstanding at December 31, 2020 84,991,715 5.27
Granted 6,244,524 26.46 12.40
Exercised ( 17,233,853 ) 4.52 367,110
Forfeited ( 1,797,498 ) 13.27
Outstanding at December 31, 2021 72,204,888 7.08
Granted 12,516,816 12.34 6.40
Exercised ( 5,898,217 ) 4.63 52,258
Forfeited ( 2,296,634 ) 16.46
Outstanding at December 31, 2022 76,526,853 7.85 5.33 745,340,712
Exercisable as of December 31, 2022 58,017,219 5.67 4.2 673,364,735
Vested and expected to vest at December 31, 2022 73,842,956 7.60 5.2 734,904,195
As of December 31, 2022, the unrecognized compensation cost related to 15,825,737 unvested share options expected to vest was $ 88,859 . This unrecognized compensation will be recognized over an estimated weighted-average amortization period of 2.4 years.
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.
Fair value of options
The Company uses the binomial option-pricing model in determining the estimated fair value of the options granted. The model requires the input of highly subjective assumptions including the estimated expected stock price volatility and, the exercise multiple for which employees are likely to exercise share options. For expected volatilities, the trading history and observation period of the Company’s own share price is used in conjunction with historical price volatilities of ordinary shares of several comparable companies in the same industry as the Company. For the exercise multiple, the Company was not able to develop an exercise pattern as reference, thus the exercise multiple is based on management’s estimation, which the Company believes is representative of the future exercise pattern of the options. The risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury Bills yield curve in effect at the time of grant.
The following table presents the range of fair values and the assumptions used to estimate those fair values of the share options granted in the years presented:
Year Ended December 31,
2022 2021 2020
Fair value of ordinary share $ 5.51 ~ $ 9.04
$ 9.94 ~ $ 14.97
$ 4.95 ~ $ 11.89
Risk-free interest rate 1.8 % ~ 3.9 %
1.1 % ~ 1.7 %
0.6 % ~ 1.1 %
Expected exercise multiple 2.8
2.8
2.8
Expected volatility 51 % ~ 60 %
51 % ~ 59 %
58 % ~ 59 %
Expected dividend yield 0 % 0 % 0 %
Contractual life 10 years 10 years 10 years
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
Restricted shares
The following table summarizes the Company’s restricted share activities under the 2016 Plan:
Numbers
of Shares Weighted-Average
Grant Date Fair Value
$
Outstanding at December 31, 2019 75,000 2.27
Granted — —
Vested ( 75,000 ) 2.27
Forfeited — —
Outstanding at December 31, 2020 — —
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.
Restricted share units
The following table summarizes the Company's restricted share unit activities under the 2016 and 2018 Plans:
Numbers
of Shares Weighted-Average
Grant Date Fair Value
$
Outstanding at December 31, 2019 26,852,267 10.72
Granted 18,820,581 14.20
Vested ( 7,302,828 ) 10.88
Forfeited ( 3,493,048 ) 11.36
Outstanding at December 31, 2020 34,876,972 12.50
Granted 17,173,767 25.58
Vested ( 10,703,381 ) 12.23
Forfeited ( 5,264,376 ) 15.82
Outstanding at December 31, 2021 36,082,982 18.33
Granted 38,707,669 12.46
Vested ( 12,533,586 ) 16.37
Forfeited ( 6,859,892 ) 16.72
Outstanding at December 31, 2022 55,397,173 14.87
Expected to vest at December 31, 2022 47,392,282 14.87
As of December 31, 2022, the unrecognized compensation cost related to unvested restricted share units expected to vest was $ 580,815 . This unrecognized compensation will be recognized over an estimated weighted-average amortization period of 2.9 years.
Share-based compensation expense
The following table summarizes total share-based compensation cost recognized for the years ended December 31, 2022, 2021 and 2020:
Year Ended December 31,
2022 2021 2020
$ $ $
Research and development 139,348 114,357 92,999
Selling, general and administrative 163,814 126,355 90,482
Total 303,162 240,712 183,481
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
18. Accumulated Other Comprehensive (Loss) Income
The movement of accumulated other comprehensive (loss) income was as follows:
Foreign Currency
Translation
Adjustments Unrealized
Gains/Losses on
Available-for-Sale
Securities Pension Liability Adjustments Total
$ $ $ $
December 31, 2020 14,184 871 ( 8,113 ) 6,942
Other comprehensive income (loss) before reclassifications 13,714 ( 4,504 ) 309 9,519
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
December 31, 2021 27,898 ( 3,700 ) ( 6,248 ) 17,950
Other comprehensive income (loss) before reclassifications ( 90,421 ) ( 5,311 ) ( 446 ) ( 96,178 )
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 )
(1) The amounts reclassified from accumulated other comprehensive (loss) income were included in other (expense) income, net in the consolidated statements of operations.
19. Shareholders’ Equity
During the years ended December 31, 2022, 2021 and 2020, the Company completed the following equity offerings:
In January 2020, the Company sold 15,895,001 ADSs, representing a 20.5 % ownership stake in the Company, to Amgen for aggregate cash proceeds of $ 2,779,241 , or $ 174.85 per ADS, pursuant to the Share Purchase Agreement executed in connection with the Amgen Collaboration Agreement. On March 17, 2020, BeiGene, Ltd. and Amgen entered into an Amendment No. 2 (the “Second Amendment”) to the Share Purchase Agreement in order to account for periodic dilution from the issuance of shares by the Company, which was restated in its entirety on September 24, 2020 (the “Restated Second Amendment”). Pursuant to the Restated Second Amendment, Amgen has an option (the “Direct Purchase Option”) to subscribe for additional ordinary shares of the Company in the form of ADSs (the “Additional Shares”) in an amount necessary to enable it to increase (and subsequently maintain) its ownership at approximately 20.6 % of the Company's outstanding shares. The Direct Purchase Option is exercisable on a monthly basis, but only if Amgen’s interest in the outstanding shares of the Company at the monthly reference date is less than 20.4 %. The Direct Purchase Option (i) will be exercisable by Amgen solely as a result of dilution arising from issuance of new shares under the Company's equity incentive plans from time to time, and (ii) is subject to annual approval by the Company's independent shareholders each year during the term of the Restated Second Amendment. The exercise period of the Direct Purchase Option commenced on December 1, 2020 and will terminate on the earliest of: (a) the date on which Amgen and its affiliates collectively own less than 20% of the outstanding share capital of the Company as a result of Amgen’s sale of shares; (b) at least 60-day advance written notice from either Amgen or the Company that such party wishes to terminate the Direct Purchase Option; or (c) December 1, 2023. The Direct Purchase Option has no vesting period.
In July 2020, the Company issued 145,838,979 ordinary shares, par value $ 0.0001 , to eight existing investors, including entities associated with Hillhouse Capital and Baker Bros. Advisors LP, as well as Amgen, in a registered direct offering under the Company's effective Registration Statement on Form S-3 (File No. 333-238181). Each ordinary share was sold for a purchase price of $ 14.2308 per share ($ 185.00 per ADS), resulting in net proceeds, after offering expenses, of $ 2,069,610 . Amgen purchased 29,614,832 ordinary shares for $ 421,443 as part of this offering. The offering was made without an underwriter or a placement agent, and as a result the Company did not pay any underwriting discounts or commissions in connection with the offering.
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
In September 2021, upon Amgen's exercise of its Direct Purchase Option, the Company issued an aggregate of 165,529 ADSs, representing 2,151,877 ordinary shares, to Amgen Inc. for a total consideration of $ 50,000 , in a private placement pursuant to a Share Purchase Agreement dated October 31, 2019, as amended on December 6, 2019 and September 24, 2020 by and between Amgen and Company.
In December 2021, the Company completed an initial public offering of (STAR Offering) on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange (SSE). The shares offered in the STAR Offering were issued to and subscribed for by permitted investors in the People’s Republic of China (PRC) in Renminbi (RMB Shares). The public offering price of the RMB Shares was RMB 192.60 per ordinary share, or $ 391.68 per ADS. In this offering, the Company sold 115,055,260 ordinary shares. 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.
20. Restricted Net Assets
The Company’s ability to pay dividends may depend on the Company receiving distributions of funds from its PRC subsidiaries. Relevant PRC laws and regulations permit payments of dividends by the Company’s PRC subsidiaries only out of its retained earnings, if any, as determined in accordance with PRC accounting standards and regulations. The results of operations reflected in the consolidated financial statements prepared in accordance with GAAP differ from those reflected in the statutory financial statements of the Company’s PRC subsidiaries.
In accordance with the company law of the PRC, a domestic enterprise is required to provide statutory reserves of at least 10 % of its annual after-tax profit until such reserve has reached 50 % of its respective registered capital based on the enterprise’s PRC statutory accounts. A domestic enterprise is also required to provide discretionary surplus reserve, at the discretion of the Board of Directors, from the profits determined in accordance with the enterprise’s PRC statutory accounts. The aforementioned reserves can only be used for specific purposes and are not distributable as cash dividends. The Company’s PRC subsidiaries were established as domestic invested enterprises and therefore were subject to the above-mentioned restrictions on distributable profits.
During the years ended December 31, 2022, 2021 and 2020, no appropriation to statutory reserves was made, because the PRC subsidiaries had an accumulated deficit as of the end of such periods.
As a result of these PRC laws and regulations, including the requirement to make annual appropriations of at least 10 % of after-tax income and set aside as general reserve fund prior to payment of dividends, the Company’s PRC subsidiaries are restricted in their ability to transfer a portion of their net assets to the Company.
Foreign exchange and other regulations in the PRC may further restrict the Company’s PRC subsidiaries from transferring funds to the Company in the form of dividends, loans, and advances. As of December 31, 2022 and 2021, amounts restricted were the net assets of the Company’s PRC subsidiaries, which amounted to 3,548,881 and $ 760,476 , respectively.
21. Employee Benefit Plans
Defined Contribution Plans
Full-time employees of the Company in the PRC participate in a government mandated defined contribution plan, pursuant to which certain pension benefits, medical care, employee housing fund and other welfare benefits are provided to employees. Chinese labor regulations require that the Company’s PRC subsidiaries make contributions to the government for these benefits based on certain percentages of the employees’ salaries. The Company has no legal obligation for the benefits beyond the contributions made. The total amounts for such employee benefits, which were expensed as incurred, were $ 83,860 , $ 63,772 and $ 23,717 for the years ended December 31, 2022, 2021 and 2020, respectively.
The Company maintains a defined contribution 401(k) savings plan (the "401(k) Plan") for U.S. employees. The 401(k) Plan covers all U.S. employees, and allows participants to defer a portion of their annual compensation on a pretax basis. In addition, the Company has a matching contribution to the 401(k) Plan, which, in the 2021 plan year, matched dollar for dollar of eligible contributions up to 4 %. Company contributions to the 401(k) plan totaled $ 10,298 , $ 7,483 and $ 4,840 in the years ended December 31, 2022, 2021 and 2020, respectively.
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BEIGENE, LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
The Company maintains a government mandated program to cover its employees in Switzerland for pension, death, or disability. The program is considered a defined contribution plan. Employer and employee contributions are made based on various percentages of salaries and wages that vary based on employee age and other factors. Company contributions into the program amounted to $ 3,887 , $ 2,986 , and $ 2,960 in the years ended December 31, 2022, 2021 and 2020, respectively.
Employee benefit expenses for the remaining subsidiaries were immaterial.
Defined Benefit Plan
The Company maintains a defined benefit pension plan covering its employees in Switzerland (the "Swiss Plan"). This plan is a government mandated fund that provides benefits to employees upon retirement, death, or disability. Contributions are made based on various percentages of participants' salaries and wages determined based on participants' age and other factors. As of December 31, 2022 and 2021, the projected benefit obligations under the Swiss Plan were approximately $ 45,835 and $ 34,517 , respectively, and plan assets were approximately $ 38,075 and $ 26,703 , respectively. The funded status of the Swiss Plan is included in other long-term liabilities in the accompanying consolidated balance sheets. The initial determination of the pension liability was recorded as other comprehensive loss during the year ended December 31, 2020 and subsequently amortized as a component of net periodic pension cost (see Note 18).
The Company's annual contribution to the Swiss Plan is estimated to be approximately $ 2,553 in 2023 and is expected to evolve thereafter proportionally with changes in staffing and compensation levels, actuarial assumptions and actual investment returns on plan assets.
The following table reflects the total expected benefit payments to Swiss Plan participants and have been estimated based on the same assumptions used to measure the Company's benefit obligations as of December 31, 2022:
Amounts
Year(s) $
2023 68
2024 545
2025 442
2026 260
2027 755
2028 – 2032
7,185
Total 9,255
22. Commitments and Contingencies
Purchase Commitments
As of December 31, 2022, the Company had purchase commitments amounting to $ 117,293 , of which $ 55,346 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $ 61,947 related to binding purchase order obligations of inventory from BMS and Amgen. The Company does not have any minimum purchase requirements for inventory from BMS or Amgen.
Capital commitments
The Company had capital commitments amounting to $ 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
Under the Amgen Collaboration Agreement, the Company is responsible for co-funding global clinical development costs for the Amgen oncology pipeline assets up to a total cap of $ 1,250,000 . The Company is funding its portion of the co-
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NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”),
except for number of shares and per share data)
development costs by contributing cash and/or development services. As of December 31, 2022, the Company's remaining co-development funding commitment was $ 595,702 .
Research and Development Commitment
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
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.
Other Business Agreements
The Company enters into agreements in the ordinary course of business with contract research organizations (CROs) to provide research and development services. These contracts are generally cancellable at any time by the Company with prior written notice.
The Company also enters into collaboration agreements with institutions and companies to license intellectual property. The Company may be obligated to make future development, regulatory and commercial milestone payments and royalty payments on future sales of specified products associated with its collaboration agreements. Payments under these agreements generally become due and payable upon achievement of such milestones or sales. These commitments are not recorded on the consolidated balance sheet because the achievement and timing of these milestones are not fixed and determinable. When the achievement of these milestones or sales have occurred, the corresponding amounts are recognized in the consolidated financial statements.
23. Segment and Geographic Information
The Company operates in one segment: pharmaceutical products. Its chief operating decision maker is the Chief Executive Officer, who makes operating decisions, assesses performance, and allocates resources on a consolidated basis.
The Company’s long-lived assets are 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. Total net revenues by geographic area are presented as follows:
Year Ended December 31,
2022 2021 2020
$ $ $
PRC 840,032 517,173 290,646
U.S. 502,626 495,265 18,228
ROW 73,263 163,845 —
Total 1,415,921 1,176,283 308,874
PRC revenues for each of the three years in the period ended December 31, 2022 consisted entirely of product sales. U.S. revenues for the year ended December 31, 2022 consisted of collaboration revenues of $ 112,916 and BRUKINSA product sales of $ 389,710 , respectively. U.S. revenues for the year ended December 31, 2021 consisted of collaboration revenue of $ 379,607 and BRUKINSA product sales of $ 115,658 , respectively. U.S. revenues for the year ended December 31, 2020 consisted entirely of BRUKINSA product sales. 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. Rest of world revenues for each of the year ended December 31, 2021 consisted primarily of collaboration revenues.
54
Supplementary Information
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. 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.
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. The following table summarizes the unaudited statements of operations for each quarter of 2022 and 2021 (in thousands except share and per share amounts).
Quarter Ended
March 31, June 30, September 30, December 31,
2022 $ $ $ $
Total revenues 306,626 341,572 387,628 380,095
Loss from operations (443,287) (439,399) (438,357) (468,622)
Net loss (435,198) (565,726) (557,556) (445,335)
Net loss attributable to BeiGene, Ltd. (435,198) (565,726) (557,556) (445,335)
Net loss per share attributable to BeiGene, Ltd., basic and diluted (0.33) (0.42) (0.41) (0.33)
Quarter Ended
March 31, June 30, September 30, December 31,
2021 $ $ $ $
Total revenues 605,872 149,992 206,440 213,979
Income (loss) from operations 70,167 (474,838) (462,325) (571,739)
Net income (loss) 55,580 (484,604) (438,114) (590,678)
Net income (loss) attributable to BeiGene, Ltd. 55,580 (484,604) (438,114) (590,678)
Net income (loss) per share attributable to BeiGene, Ltd., basic 0.05 (0.41) (0.36) (0.48)
Net income (loss) per share attributable to BeiGene, Ltd., diluted 0.04 (0.41) (0.36) (0.48)
55
Table of Contents
Exhibit Index
Exhibit No. Exhibit Description Filed/ Furnished
Herewith Incorporated by Reference
Herein from Form or Schedule Filing Date SEC File/
Reg. Number
3.1 Sixth Amended and Restated Memorandum and Articles of Association of the Registrant, as currently in effect
8-K
(Exhibit 3.1) 12/17/2021 001-37686
4.1 .1 Deposit Agreement dated February 5, 2016 by and among the Company, the Depositary and holders of the American Depositary Receipts
8-K
(Exhibit 4.1) 2/11/2016 001-37686
.2 Amendment No. 1 to Deposit Agreement, dated April 11, 2016, by and among the Registrant, Citibank, N.A. and holders of the American Depositary Receipts
8-K
(Exhibit 4.1) 4/11/2016 001-37686
.3 Letter Agreement, dated as of July 11, 2016, between the Registrant and Citibank, N.A.
10-Q
(Exhibit 4.7) 8/10/2016 001-37686
.4 Form of Letter Agreement between the Registrant and Citibank, N.A.
10-Q
(Exhibit 4.9) 5/10/2017 001-37686
4.2 Form of American Depositary Receipt (included in Exhibit 4.1.1)
4.3 Specimen Certificate for Ordinary Shares
S-1
(Exhibit 4.3) 12/9/2015 333-207459
4.4 .1 Second Amended and Restated Investors’ Rights Agreement, dated as of April 21, 2015, by and among the Registrant and certain shareholders named therein
S-1
(Exhibit 4.4) 10/16/2015 333-207459
.2 Amendment No. 1 to Second Amended and Restated Investors’ Rights Agreement, dated January 26, 2016, by and among the Registrant and certain shareholders named therein
S-1
(Exhibit 10.21) 1/27/2016 333-207459
4.5 .1 Registration Rights Agreement, dated as of November 16, 2016, by and among the Registrant and the investors named therein
8-K
(Exhibit 4.1) 11/17/2016 001-37686
.2 Amendment No. 1 to Registration Rights Agreement, dated December 1, 2020, between the Company and the Investors
8-K
(Exhibit 10.1) 12/2/2020 001-37686
4.6 Description of the Registrant 's Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934
X
Collaboration, License and Commercial Agreements
10.1# .1# License and Supply Agreement, dated July 5, 2017, by and between the Registrant and Celgene Logistics Sàrl
10-Q
(Exhibit 10.3) 11/13/2017 001-37686
Table of Contents
Exhibit No. Exhibit Description Filed/ Furnished
Herewith Incorporated by Reference
Herein from Form or Schedule Filing Date SEC File/
Reg. Number
.2 Assignment and Assumption Agreement, dated December 29, 2017, by and between the Registrant and BeiGene Switzerland GmbH
10-K
(Exhibit 10.6.1)
3/2/2020 001-37686
10.2 Share Subscription Agreement, dated July 5, 2017, by and between Celgene Switzerland LLC and the Registrant
8-K
(Exhibit 10.1) 7/6/2017 001-37686
10.3## Letter Agreement, dated June 14, 2019, by and among the Registrant, BeiGene Switzerland GmbH, Celgene Corporation and Celgene Switzerland LLC, to terminate the Amended and Restated Exclusive License and Collaboration Agreement, dated August 31, 2017
10-Q
(Exhibit 10.1) 8/8/2019 001-37686
10.4## .1## Share Purchase Agreement, dated October 31, 2019, by and between the Registrant and Amgen Inc.
10-K
(Exhibit 10.9) 3/2/2020 001-37686
.2 Amendment No. 1 to Share Purchase Agreement, dated December 6, 2019, by and between the Registrant and Amgen Inc.
10-K
(Exhibit 10.10) 3/2/2020 001-37686
.3 Restated Amendment No. 2 to Share Purchase Agreement, dated September 24, 2020, by and between the Registrant and Amgen Inc.
8-K
(Exhibit 10.1) 9/24/2020 001-37686
.4 Amendment No. 3 to Share Purchase Agreement, dated January 30, 2023, by and between the Registrant and Amgen Inc.
X
Table of Contents
Exhibit No. Exhibit Description Filed/ Furnished
Herewith Incorporated by Reference
Herein from Form or Schedule Filing Date SEC File/
Reg. Number
10.5## .1## Collaboration Agreement, dated October 31, 2019, by and among the Registrant, BeiGene Switzerland GmbH and Amgen Inc.
10-K
(Exhibit 10.11) 3/2/2020 001-37686
.2## First Amendment to Collaboration Agreement, dated April 20, 2022, by and among the Registrant, BeiGene Switzerland GmbH and Amgen Inc.
10-Q
(Exhibit 10.1) 8/8/2022 001-37686
10.6 Guarantee, dated October 31, 2019, by and between the Registrant and Amgen Inc.
10-K
(Exhibit 10.12) 3/2/2020 001-37686
10.7## .1## Collaboration and License Agreement, dated January 11, 2021, by and between BeiGene Switzerland GmbH and Novartis Pharma AG
10-Q
(Exhibit 10.1) 5/6/2021 001-37686
.2## Option, Collaboration and License Agreement, dated December 19, 2021, by and between BeiGene Switzerland GmbH and Novartis Pharma AG
10-K
(Exhibit 10.7.2) 2/28/2022 001-37686
Equity and Other Compensation Plans
10.8† 2011 Option Plan, as amended and form of option agreements thereunder
S-1
(Exhibit 10.1) 10/16/2015 333-207459
10.9† .1† Second Amended and Restated 2016 Share Option and Incentive Plan
8-K
(Exhibit 10.1) 12/12/2018 001-37686
.2† Amendment No. 1 to the Second Amended and Restated 2016 Share Option and Equity Plan
8-K
(Exhibit 10.1) 6/17/2020 001-37686
.3† Amendment No. 2 to the Second Amended and Restated 2016 Share Option and Equity Plan
8-K
(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-Q
(Exhibit 10.4) 8/8/2022 001-37686
.5† Form of Global Restricted Share Unit Award Agreement for Employees under the Second Amended and Restated 2016 Share Option and Incentive Plan
10-Q
(Exhibit 10.2) 11/9/2022 001-37686
.6† Form of Global Restricted Share Unit Award Agreement for Consultants under the Second Amended and Restated 2016 Share Option and Incentive Plan
10-Q
(Exhibit 10.3) 11/9/2022 001-37686
.7† Form of Global Non-Qualified Share Option Agreement for Employees under the Second Amended and Restated 2016 Share Option and Incentive Plan
10-Q
(Exhibit 10.1) 11/9/2022 001-37686
.8† Form of Global Non-Qualified Share Option Agreement for Non-Employee Directors under the Second Amended and Restated 2016 Share Option and Incentive Plan
10-Q
(Exhibit 10.7) 8/8/2022 001-37686
.9† Form of Global Non-Qualified Share Option Agreement for Non-Employee Consultants under the Second Amended and Restated 2016 Share Option and Incentive Plan
10-Q
(Exhibit 10.8) 8/8/2022 001-37686
10.10† .1† Third Amended and Restated 2018 Employee Share Purchase Plan
10-Q
(Exhibit 10.7) 8/5/2021 001-37686
Table of Contents
Exhibit No. Exhibit Description Filed/ Furnished
Herewith Incorporated by Reference
Herein from Form or Schedule Filing Date SEC File/
Reg. Number
10.11† Senior Executive Cash Incentive Bonus Plan
S-1
(Exhibit 10.19) 1/19/2016 333-207459
10.12† Independent Director Compensation Policy, as amended
8-K
(Exhibit 10.1) 2/22/2022 001-37686
Agreements with Executive Officers and Directors
10.14† Form of Indemnification Agreement, entered into between the Registrant and its directors and officers
S-1
(Exhibit 10.3) 1/19/2016 333-207459
10.15† Employment Agreement, dated April 25, 2017, by and between the Registrant and John V. Oyler
8-K
(Exhibit 10.1) 4/26/2017 001-37686
10.16† .1† Executive Employment Agreement, dated April 28, 2018, by and between BeiGene (Beijing) Co., Ltd. and Xiaobin Wu
10-Q
(Exhibit 10.1) 8/9/2018 001-37686
.2† Employment Apportionment Agreement, dated March 1, 2020, by and between BeiGene (Beijing) Co., Ltd., BeiGene Guangzhou Biologics Manufacturing Co., Ltd. and Xiaobin Wu
10-Q
(Exhibit 10.2) 5/11/2020 001-37686
10.17† Offer letter, dated May 29, 2020, by and between the Registrant and Julia Wang
10-Q
(Exhibit 10.9) 8/5/2021 001-37686
10.18† Consulting Agreement, dated February 24, 2021, by and between the Registrant and Xiaodong Wang
10-K
(Exhibit 10.20) 2/25/2021 001-37686
10.19† Employment Agreement, dated December 30, 2021, by and between BeiGene (Shanghai) Co., Ltd. and Lai Wang
10-K
(Exhibit 10.20) 2/28/2022 001-37686
16.1 Letter from Ernst & Young Hua Ming LLP addressed to the U.S. Securities and Exchange Commission dated March 25, 2022
8-K
(Exhibit 16.1) 3/25/2022 001-37686
21.1 List of Subsidiaries of the Registrant
X
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Exhibit No. Exhibit Description Filed/ Furnished
Herewith Incorporated by Reference
Herein from Form or Schedule Filing Date SEC File/
Reg. Number
23.1 Consent of Ernst & Young LLP
X
23.2 Consent of Ernst & Young Hua Ming LLP
X
31.1 Certification of Principal Executive Officer pursuant to Rule 13a‑14(a) and Rule 15d‑14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes‑Oxley Act of 2002
X
31.2 Certification of Principal Financial Officer pursuant to Rule 13a‑14(a) and Rule 15d‑14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes‑Oxley Act of 2002
X
32.1* Certification of Principal Executive Officer and Principle Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes‑Oxley Act of 2002
X
99.1 Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
X
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
101.SCH Inline XBRL Taxonomy Extension Schema Document X
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document X
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document X
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document X
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document X
104 Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.*) X
† Indicates a management contract or any compensatory plan, contract or arrangement.
# Confidential treatment has been granted by the U.S. Securities and Exchange Commission as to certain portions of this exhibit omitted and filed separately.
## 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.
Table of Contents
SIGNATURES
Pursuant to the requirements of the Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Form 10‑K to be signed on its behalf by the undersigned, thereunto duly authorized.
BEIGENE, LTD.
Date: February 27, 2023 By: /s/ JOHN V. OYLER
John V. Oyler
Chief Executive Officer and Chairman
(Principal Executive Officer)
Table of Contents
POWER OF ATTORNEY
Each person whose individual signature appears below hereby authorizes and appoints John V. 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:
Signature Title Date
/s/ JOHN V. OYLER Chief Executive Officer and Chairman February 27, 2023
John V. Oyler (Principal Executive Officer)
/s/ JULIA WANG Chief Financial Officer February 27, 2023
Julia Wang (Principal Financial and Accounting Officer)
/s/ MARGARET DUGAN Director February 27, 2023
Margaret Dugan
/s/ DONALD W. GLAZER Director February 27, 2023
Donald W. Glazer
/s/ MICHAEL GOLLER Director February 27, 2023
Michael Goller
/s/ ANTHONY C. HOOPER Director February 27, 2023
Anthony C. Hooper
/s/ RANJEEV KRISHANA Director February 27, 2023
Ranjeev Krishana
/s/ THOMAS MALLEY Director February 27, 2023
Thomas Malley
/s/ ALESSANDRO RIVA Director February 27, 2023
Alessandro Riva
/s/ CORAZON (CORSEE) D. SANDERS Director February 27, 2023
Corazon (Corsee) D. Sanders
/s/ XIAODONG WANG Director February 27, 2023
Xiaodong Wang
/s/ QINGQING YI Director February 27, 2023
Qingqing Yi