4 unchanged sentences
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.
−Removed: In designing and evaluating the disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurances of achieving the desired
−Removed: control objectives, and management necessarily was required to apply its judgment in designing and evaluating the controls and procedures.
+Added: In designing and evaluating the disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurances of achieving the desired 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
10 unchanged sentences
Other Information
−Removed: On October 31, 2019, our wholly-owned subsidiary, BeiGene Switzerland GmbH (“BeiGene Switzerland”), entered into a collaboration agreement with Amgen Inc.
−Removed: (“Amgen”), which became effective on January 2, 2020 (as amended, the "Collaboration Agreement").
−Removed: 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.
−Removed: 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.
−Removed: 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;
−Removed: and (ii) cooperate in good faith to prepare a transition plan with the anticipated termination of AMG 510 from the Collaboration Agreement.
−Removed: 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.
+Added: Not applicable.
+Added: The following table describes for the quarterly period covered by this report each trading arrangement for the purchase or sale of Company securities adopted , modified or terminated by our directors and officers that is either (1) a contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c), or a “Rule 10b5-1 trading arrangement,” or (2) a “non-Rule 10b5-1 trading arrangement” (as defined in Item 408(c) of Regulation S-K):
+Added: Name ( Title )
+Added: Action Taken ( Date of Action )
+Added: Type of Trading Arrangement
+Added: Nature of Trading Arrangement
+Added: Duration of Trading Arrangement
+Added: Aggregate Number of Securities
+Added: Oyler ( Chief Executive Officer and Chairman )
+Added: ( December 1, 2023 )
+Added: Non-Rule 10b5-1 trading arrangement for sell-to-cover transaction relating to RSU equity award.
+Added: Until final settlement of covered RSU
+Added: Indeterminable (1)
+Added: ( Chief Financial Officer )
+Added: ( December 8, 2023 )
+Added: Non-Rule 10b5-1 trading arrangement for sell-to-cover transaction relating to RSU equity award.
+Added: Until final settlement of covered RSU
+Added: Indeterminable (1)
+Added: Xiaobin Wu ( President, Chief Operating Officer and General Manager of China )
+Added: ( December 12, 2023 )
+Added: Non-Rule 10b5-1 trading arrangement for sell-to-cover transaction relating to RSU equity award.
+Added: Until final settlement of covered RSU
+Added: Indeterminable (1)
+Added: ( Global Head of R&D )
+Added: ( December 8, 2023 )
+Added: Non-Rule 10b5-1 trading arrangement for sell-to-cover transaction relating to RSU equity award.
+Added: Until final settlement of covered RSU
+Added: Indeterminable (1)
+Added: ( Senior Vice President, General Counsel )
+Added: ( November 28, 2023 )
+Added: Non-Rule 10b5-1 trading arrangement for sell-to-cover transaction relating to RSU equity award.
+Added: Until final settlement of covered RSU
+Added: Indeterminable (1)
+Added: Oyler ( Chief Executive Officer and Chairman )
+Added: Adoption ( December 12, 2023 )
+Added: Rule 10b5-1 trading arrangement
+Added: March 12, 2025
+Added: Restricted Stock Units (“RSUs”) equal to 249,494 ADSs plus an additional sale of ADSs with an aggregate value of up to US$1.5 million net of commission and fees associated with the sale.
+Added: Xiaobin Wu ( President, Chief Operating Officer and General Manager of China )
+Added: Modification ( November 22, 2023 )
+Added: Rule 10b5-1 trading arrangement
+Added: August 29, 2024
+Added: Employee stock options equal to 207,684 ADSs
+Added: (1) The number of shares that will be sold to satisfy applicable tax withholding obligations upon vesting of RSUs is unknown as the number will vary based on the extent to which vesting conditions are satisfied and the market price of the Company’s common stock at the time of settlement.
+Added: This trading arrangement provides for the automatic sale of shares that would otherwise be issuable on the settlement date in an amount sufficient to satisfy the applicable withholding obligation, with the proceeds of the sale delivered to the Company in satisfaction of the applicable withholding obligation.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
2 unchanged sentences
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.
−Removed: 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.
−Removed: Given that Ernst & Young LLP (United States) now serves as the principal accountant to audit our consolidated financial statements, we expect to be able to comply with the HFCAA and AHFCAA and certify that we have retained a registered public accounting firm that the PCAOB has determined it is able to inspect or investigate which would preclude a further finding by the SEC that we are a Commission-Identified Issuer.
+Added: On the same day, our audit committee approved the engagement of Ernst & Young LLP, located in Boston, Massachusetts, U.S., as the Company’s independent registered public accounting firm for the audit of our financial statements and internal control over financial reporting commencing for the fiscal year ending December 31, 2022.
+Added: Given that Ernst & Young LLP (U.S.) 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.
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.
−Removed: To the extent known by the Company, the Company is not aware of and has no reason to believe that:
−Removed: 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;
−Removed: any official of the Chinese government or Hong Kong SAR is a board member or officer of the Company or its operating subsidiaries;
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: 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.
+Added: Furthermore, to the extent known by the Company, the Company is not aware of and has no reason to believe that that any government entity in the foreign jurisdiction where its consolidated foreign operating entities are incorporated or otherwise organized owns shares of any capital stock of record of its consolidated foreign operating entities.
+Added: The Company has determined that no governmental entity in China has a controlling financial interest in the Company or its consolidated foreign operating entities.
+Added: To the extent known by the Company, the Company is not aware of and has no reason to believe that any official of the Chinese Communist Party is a board member of the Company or its consolidated foreign operating entities.
+Added: The articles of incorporation of the Company, as amended, and those of its consolidated foreign operating entities, do not contain any wording received from any charter of the Chinese Communist Party.
Directors, Executive Officers and Corporate Governance
10 unchanged sentences
Securities and Exchange Commission not later than 120 days after the close of our fiscal year ended December 31, 2023.
−Removed: Principal Accounting Fees and Services
+Added: Principal Accountant Fees and Services
Our independent public accounting firm is Ernst & Young LLP (PCAOB ID:
−Removed: 00 42 ), located in Boston, Massachusetts, United States.
−Removed: Our independent public accounting firm for the years ended December 31, 2021 and 2020 was Ernst & Young Hua Ming LLP (PCAOB ID:
+Added: 00 42 ), located in Boston, Massachusetts, U.S.
+Added: Our independent public accounting firm for the year ended December 31, 2021 was Ernst & Young Hua Ming LLP (PCAOB ID:
1408), located in Beijing, People’s Republic of China.
1 unchanged sentence
Securities and Exchange Commission not later than 120 days after the close of our fiscal year ended December 31, 2023.
−Removed: Exhibits, Financial Statement Schedules
+Added: Exhibits and 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.
7 unchanged sentences
Reports of Independent Registered Public Accounting Firm
−Removed: Consolidated balance sheets as of December 31, 202 2 and 202 1
Consolidated statements of operations for the years ended December 31, 20 23 , 20 22 and 20 21
+Added: Consolidated balance sheets as of December 31, 2023 and 2022
Consolidated statements of comprehensive loss for the years ended December 31, 202 3 , 202 2 and 202 1
5 unchanged sentences
Opinion on the Financial Statements
−Removed: We have audited the accompanying consolidated balance sheet of BeiGene, Ltd.
−Removed: 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”).
−Removed: 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.
+Added: We have audited the accompanying consolidated balance sheets of BeiGene, Ltd.
+Added: (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive loss, shareholders’ equity and cash flows for each of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, in conformity with U.S.
generally accepted accounting principles.
2 unchanged sentences
These financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s financial statements based on our audit.
+Added: 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 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.
−Removed: We conducted our audit in accordance with the standards of the PCAOB.
+Added: 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.
−Removed: Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
+Added: 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.
−Removed: 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.
−Removed: We believe that our audit provides a reasonable basis for our opinion.
−Removed: Critical Audit Matters
+Added: 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.
+Added: We believe that our audits provide a reasonable basis for our opinion.
+Added: Critical Audit Matter
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:
22 unchanged sentences
Opinion on the Financial Statements
−Removed: We have audited the accompanying consolidated balance sheet of BeiGene, Ltd.
−Removed: (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").
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2021, in conformity with U.S.
+Added: We have audited the accompanying consolidated statements of operations, comprehensive loss, cash flows and shareholders’ equity of BeiGene, Ltd.
+Added: (the Company) for the year ended December 31, 2021, and the related notes (collectively referred to as the “consolidated financial statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the results of operations and cash flows of the Company for the year ended December 31, 2021, in conformity with U.S.
generally accepted accounting principles.
14 unchanged sentences
February 28, 2022,
−Removed: except for the effects on the consolidated financial statements of the correction of an error as described in Notes 2 and 3, as to which the date is
+Added: except for the effects on the consolidated financial statements of the correction of an error, as to which the date is
February 27, 2023
5 unchanged sentences
(the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on the COSO criteria.
−Removed: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance 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.
+Added: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive loss, shareholders’ equity and cash flows for each of the two years in the period ended December 31, 2023, and the related notes and our report dated February 26, 2024 expressed an unqualified opinion thereon .
Basis for Opinion
18 unchanged sentences
BEIGENE, LTD.
+Added: CONSOLIDATED STATEMENTS OF OPERATIONS
+Added: (Amounts in thousands of U.S.
+Added: Dollars (“$”), except for number of shares and per share data)
+Added: Year Ended December 31,
+Added: Note 2023 2022 2021
+Added: Product revenue, net 13 2,189,852 1,254,612 633,987
+Added: Collaboration revenue 3 268,927 161,309 542,296
+Added: Total revenues 2,458,779 1,415,921 1,176,283
+Added: Cost of sales - product 379,920 286,475 164,906
+Added: Gross profit 2,078,859 1,129,446 1,011,377
+Added: Operating expenses
+Added: Research and development 1,778,594 1,640,508 1,459,239
+Added: Selling, general and administrative 1,504,501 1,277,852 990,123
+Added: Amortization of intangible assets 9 3,500 751 750
+Added: Total operating expenses 3,286,595 2,919,111 2,450,112
+Added: Loss from operations ( 1,207,736 ) ( 1,789,665 ) ( 1,438,735 )
+Added: Interest income (expense), net 74,009 52,480 ( 15,757 )
+Added: Other income (expense), net 5 307,891 ( 223,852 ) 15,904
+Added: Loss before income taxes ( 825,836 ) ( 1,961,037 ) ( 1,438,588 )
+Added: Income tax expense 10 55,872 42,778 19,228
+Added: Net loss ( 881,708 ) ( 2,003,815 ) ( 1,457,816 )
+Added: Net loss per share 14 ( 0.65 ) ( 1.49 ) ( 1.21 )
+Added: Weighted-average shares outstanding—basic and diluted 14 1,357,034,547 1,340,729,572 1,206,210,049
+Added: Net loss per American Depositary Share (“ADS”) ( 8.45 ) ( 19.43 ) ( 15.71 )
+Added: Weighted-average ADSs outstanding—basic and diluted 104,387,273 103,133,044 92,785,388
+Added: The accompanying notes are an integral part of these consolidated financial statements.
+Added: BEIGENE, LTD.
CONSOLIDATED BALANCE SHEETS
8 unchanged sentences
Accounts receivable, net 358,027 173,168
−Removed: Inventories 7 282,346 242,626
+Added: Inventories, net 6 416,122 282,346
Prepaid expenses and other current assets 11 243,392 216,553
Total current assets 4,203,414 5,207,078
−Removed: Long-term restricted cash 5 5,277 6,881
Property, plant and equipment, net 8 1,324,154 845,946
24 unchanged sentences
Commitments and contingencies 20
+Added: Shareholders’ equity:
Ordinary shares, 0.0001 par value per share;
2 unchanged sentences
Additional paid-in capital 11,598,688 11,540,979
−Removed: Accumulated other comprehensive (loss) income 18 ( 77,417 ) 17,950
+Added: Accumulated other comprehensive loss 16 ( 99,446 ) ( 77,417 )
Accumulated deficit ( 7,962,050 ) ( 7,080,342 )
−Removed: Total equity 4,383,355 6,132,563
−Removed: Total liabilities and equity 6,379,290 8,535,525
−Removed: The accompanying notes are an integral part of these consolidated financial statements.
−Removed: BEIGENE, LTD.
−Removed: CONSOLIDATED STATEMENTS OF OPERATIONS
−Removed: (Amounts in thousands of U.S.
−Removed: Dollars (“$”), except for number of shares and per share data)
−Removed: Year Ended December 31,
−Removed: Note 2022 2021 2020
−Removed: Product revenue, net 15 1,254,612 633,987 308,874
−Removed: Collaboration revenue 4 161,309 542,296 —
−Removed: Total revenues 1,415,921 1,176,283 308,874
−Removed: Cost of sales - product 286,475 164,906 70,657
−Removed: Research and development 1,640,508 1,459,239 1,294,877
−Removed: Selling, general and administrative 1,277,852 990,123 600,176
−Removed: Amortization of intangible assets 11 751 750 846
−Removed: Total expenses 3,205,586 2,615,018 1,966,556
−Removed: Loss from operations ( 1,789,665 ) ( 1,438,735 ) ( 1,657,682 )
−Removed: Interest income (expense), net 52,480 ( 15,757 ) 1,998
−Removed: Other (expense) income, net 6 ( 223,852 ) 15,904 37,490
−Removed: Loss before income taxes ( 1,961,037 ) ( 1,438,588 ) ( 1,618,194 )
−Removed: Income tax expense 12 42,778 19,228 10,397
−Removed: Net loss ( 2,003,815 ) ( 1,457,816 ) ( 1,628,591 )
−Removed: net loss attributable to noncontrolling interests — — ( 3,617 )
−Removed: Net loss attributable to BeiGene, Ltd.
−Removed: ( 2,003,815 ) ( 1,457,816 ) ( 1,624,974 )
−Removed: Net loss per share attributable to BeiGene, Ltd., basic and diluted 16 ( 1.49 ) ( 1.21 ) ( 1.50 )
−Removed: Weighted-average shares outstanding, basic and diluted 16 1,340,729,572 1,206,210,049 1,085,131,783
−Removed: Net loss per American Depositary Share (ADS), basic and diluted ( 19.43 ) ( 15.71 ) ( 19.47 )
−Removed: Weighted-average ADSs outstanding, basic and diluted 103,133,044 92,785,388 83,471,676
+Added: Total shareholders’ equity 3,537,327 4,383,355
+Added: Total liabilities and shareholders’ equity 5,805,275 6,379,290
The accompanying notes are an integral part of these consolidated financial statements.
8 unchanged sentences
Foreign currency translation adjustments 16 ( 25,464 ) ( 90,421 ) 13,714
−Removed: Pension liability adjustments 21 365 1,865 ( 8,113 )
+Added: Pension liability adjustments, net 19 ( 5,611 ) 365 1,865
Unrealized holding loss, net 16 9,046 ( 5,311 ) ( 4,571 )
Comprehensive loss ( 903,737 ) ( 2,099,182 ) ( 1,446,808 )
−Removed: comprehensive loss attributable to noncontrolling interests — — ( 3,489 )
−Removed: Comprehensive loss attributable to BeiGene, Ltd.
−Removed: ( 2,099,182 ) ( 1,446,808 ) ( 1,610,031 )
The accompanying notes are an integral part of these consolidated financial statements.
12 unchanged sentences
Amortization of research and development cost share liability 3 ( 55,294 ) ( 96,402 ) ( 112,486 )
−Removed: Unrealized losses (gains) on equity investments 6 21,996 ( 7,632 ) ( 11,826 )
+Added: Unrealized losses (gains) on long-term investments 5 16,221 21,996 ( 7,632 )
Deferred income tax expense 689 2,059 3,377
+Added: Gain on BMS termination settlement ( 362,917 ) — —
Other items, net ( 5,998 ) 9,047 23,510
15 unchanged sentences
Purchase of long-term investments 5 ( 14,900 ) ( 15,911 ) ( 43,500 )
−Removed: Other investing activities — — ( 2,025 )
−Removed: Net cash provided by (used in) investing activities 1,077,123 640,659 ( 3,168,366 )
+Added: Net cash provided by investing activities 60,004 1,077,123 640,659
Cash flows from financing activities:
1 unchanged sentence
Proceeds from sale of ordinary shares, net of cost 17 — — 50,000
−Removed: Proceeds from research and development cost share liability 4 — — 616,834
−Removed: Payment to acquire joint venture (JV) minority interest 8 — — ( 28,723 )
Proceeds from long-term loan 12 22,502 37,372 16,838
3 unchanged sentences
Proceeds from option exercises and employee share purchase plan 55,712 46,964 92,762
−Removed: Net cash (used in) provided by financing activities ( 18,971 ) 3,636,911 5,202,826
+Added: Net cash provided by (used in) financing activities 416,478 ( 18,971 ) 3,636,911
Effect of foreign exchange rate changes, net ( 8,082 ) ( 69,383 ) 14,035
16 unchanged sentences
Dollars (“$”), except for number of shares and per share data)
−Removed: Attributable to BeiGene, Ltd.
Ordinary Shares Additional
2 unchanged sentences
Income/(Loss) Accumulated
−Removed: Deficit Total Non-
−Removed: Shares Amount Total
−Removed: $ $ $ $ $ $ $
+Added: Deficit Total
+Added: Shares Amount
Balance at December 31, 2020 1,190,821,941 118 7,414,932 6,942 ( 3,618,711 ) 3,803,281
+Added: Issuance of ordinary shares in connection with STAR Offering 115,055,260 12 3,392,604 — — 3,392,616
Proceeds from issuance of ordinary shares, net of cost 2,151,877 — 50,000 — — 50,000
−Removed: 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 28,778,893 3 92,759 — — 92,762
−Removed: Use of shares reserved for share option exercises and RSU releases ( 1,013,641 ) 1 — — — 1 — 1
+Added: Use of shares reserved for share option exercises ( 2,003,690 ) — — — — —
Share-based compensation — — 240,712 — — 240,712
−Removed: Deconsolidation of a subsidiary — — — — — — ( 3,545 ) ( 3,545 )
−Removed: Acquisition of joint venture (JV) minority interest — — ( 19,599 ) — — ( 19,599 ) ( 9,116 ) ( 28,715 )
Other comprehensive income — — — 11,008 — 11,008
1 unchanged sentence
Balance at December 31, 2021 1,334,804,281 133 11,191,007 17,950 ( 5,076,527 ) 6,132,563
−Removed: Issuance of ordinary shares in connection with STAR Offering 115,055,260 12 3,392,604 — — 3,392,616 — 3,392,616
−Removed: Proceeds from issuance of ordinary shares, net of cost 2,151,877 — 50,000 — — 50,000 — 50,000
+Added: Cost from issuance of ordinary shares — — ( 152 ) — — ( 152 )
+Added: Issuance 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
−Removed: Use of shares reserved for share option exercises ( 2,003,690 ) — — — — — — —
Share-based compensation — — 303,162 — — 303,162
−Removed: Other comprehensive income — — — 11,008 — 11,008 11,008
+Added: Other comprehensive loss — — — ( 95,367 ) — ( 95,367 )
Net loss — — — — ( 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
−Removed: Cost from issuance of ordinary shares — — ( 152 ) — — ( 152 ) — ( 152 )
−Removed: Use of shares reserved for share option exercises 1,375,621 — — — — — — —
+Added: Issuance of shares reserved for share option exercises 84,227 — — — — —
Exercise of options, ESPP and release of RSUs 26,561,925 2 53,006 — — 53,008
+Added: Cancellation of ordinary shares ( 23,273,108 ) ( 2 ) ( 362,915 ) — — ( 362,917 )
Share-based compensation — — 367,618 — — 367,618
10 unchanged sentences
BeiGene, Ltd.
−Removed: (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.
−Removed: The Company currently has three approved medicines that were discovered and developed in its own labs, including BRUKINSA ® , a small molecule inhibitor of Bruton’s Tyrosine Kinase (BTK) for the treatment of various blood cancers;
−Removed: tislelizumab, an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers;
−Removed: and pamiparib, a selective small molecule inhibitor of PARP1 and PARP2.
−Removed: The Company has obtained approvals to market BRUKINSA in the United States, the People's Republic of China (China or the PRC), the European Union (EU), the United Kingdom ("UK"), Canada, Australia and additional international markets, and tislelizumab and pamiparib in China.
−Removed: By leveraging its China commercial capabilities, the Company has in-licensed the rights to distribute 13 approved medicines for the China market.
+Added: (the “Company”, “BeiGene”, “it”, “its”) is a global oncology company discovering and developing innovative treatments that are more accessible and affordable to cancer patients worldwide.
+Added: The Company generated global revenue of approximately $ 2.5 billion in 2023, which increased by approximately $ 1.0 billion, while reducing its net loss by approximately $ 1.1 billion in comparison to 2022.
+Added: The Company currently has three approved medicines that were internally discovered and developed, including BRUKINSA ® (zanubrutinib), a small molecule inhibitor of Bruton’s Tyrosine Kinase (“BTK”) for the treatment of various blood cancers;
+Added: TEVIMBRA ® (tislelizumab), an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers;
+Added: and PARTRUVIX ® (pamiparib), a selective small molecule inhibitor of PARP1 and PARP2.
+Added: The Company has obtained approvals to market BRUKINSA in the United States (“U.S.”), the People’s Republic of China (“China” or the “PRC”), the European Union (“EU”), the United Kingdom (“UK”), Canada, Australia, and additional international markets;
+Added: TEVIMBRA (tislelizumab) in the EU and China;
+Added: and PARTRUVIX in China.
+Added: By leveraging its strong commercial capabilities, the Company has in-licensed the rights to distribute an additional 14 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.
−Removed: ("Amgen") and Novartis Pharma AG ("Novartis") to develop and commercialize innovative medicines.
+Added: (“Amgen”) and Beijing Novartis Pharma Co., Ltd.
+Added: (“Novartis”) to develop and commercialize innovative medicines.
The Company is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe.
−Removed: Its internal clinical development capabilities are deep, including a more than 2,700 -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.
−Removed: This includes more than 30 pivotal or potentially registration-enabling trials across its portfolio, including three internally discovered, approved medicines.
−Removed: The Company has enrolled in its clinical trials more than 18,000 subjects, of which approximately one-half have been outside of China.
−Removed: The Company has built, and is expanding, its internal manufacturing capabilities, through its state-of-the-art biologic and small molecule manufacturing facilities in China to support current and potential future demand of its medicines, and is building a commercial-stage biologics manufacturing and clinical R&D center in New Jersey.
+Added: Recognizing the importance of clinical trial activities in its industry and the challenges associated with outsourcing to third-party contract research organizations (“CROs”), the Company has built its own 3,000 + person internal clinical team and is largely CRO-free.
+Added: The Company has conducted more than 130 clinical trials in-house, with over 22,000 subjects enrolled in approximately 45 regions.
+Added: This includes more than 40 pivotal or potentially registration-enabling trials across its portfolio.
+Added: The Company has built, and is expanding, its internal manufacturing capabilities.
+Added: The Company is building a commercial-stage biologics manufacturing and clinical R&D center in at the Princeton West Innovation Park in Hopewell, New Jersey (the “Hopewell facility”), in addition to its existing state-of-the-art biologic and small molecule manufacturing facilities in China to support current and potential future demand of its medicines.
The Company also works with high quality contract manufacturing organizations (“CMOs”) to manufacture its internally developed clinical and commercial products.
−Removed: 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.
+Added: Since its inception in 2010, the Company has become a fully integrated global organization of over 10,000 employees worldwide, including in the U.S., China, and Europe.
Summary of Significant Accounting Policies
4 unchanged sentences
All significant intercompany transactions and balances between the Company and its wholly-owned subsidiaries are eliminated upon consolidation.
−Removed: Noncontrolling interests are recognized to reflect the portion of the equity of subsidiaries which are not attributable, directly or indirectly, to the controlling shareholders.
−Removed: Prior to 2020, the Company consolidated its interests in its joint ventures, BeiGene Biologics Co., Ltd.
−Removed: (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.
−Removed: 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).
−Removed: In November 2020, the Company acquired the remaining equity interest in BeiGene Biologics.
−Removed: Subsequent to the share purchase, BeiGene Biologics is a wholly owned subsidiary of the Company (see Note 8).
−Removed: Use of Estimates
−Removed: The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period.
−Removed: Areas where management uses subjective judgment include, but are not limited to, estimating the useful lives of long-lived assets, estimating variable consideration in product sales and collaboration revenue arrangements, identifying separate accounting units and the
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: 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.
+Added: Use of Estimates
+Added: 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.
+Added: Areas where management uses subjective judgment include, but are not limited to, estimating the useful lives of long-lived assets, estimating variable consideration in product sales and collaboration revenue arrangements, identifying separate accounting units and the standalone selling price of each performance obligation in the Company’s revenue arrangements, 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.
2 unchanged sentences
Functional currency
−Removed: The Company uses the United States dollar ("$" or U.S.
+Added: The Company uses the U.S.
+Added: dollar (“$” or U.S.
dollar) as its reporting currency.
−Removed: Operations in subsidiaries are recorded in the functional currency of the respective subsidiary.
+Added: Transactions 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 .
1 unchanged sentence
For subsidiaries whose functional currencies are not the U.S.
−Removed: 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.
+Added: dollar, the Company uses the average exchange rate for the period 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.
11 unchanged sentences
The Company classifies restricted cash as current or non-current based on the term of the restriction.
−Removed: 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.
+Added: In addition to the restricted cash balances above, the Company is required by the PRC securities law to use the proceeds from the STAR offering in strict compliance with the planned uses as disclosed in the PRC offering prospectus as well as those disclosed in the Company’s proceeds management policy approved by its board of directors.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Accounts Receivable and Allowance for Credit Losses
4 unchanged sentences
Accounts receivable are written off after all collection efforts have ceased.
−Removed: Prior to the regulatory approval of product candidates, the Company may incur expenses for the manufacture of drug product to support the commercial launch of those products.
+Added: Prior to the regulatory approval of product candidates, the Company may incur costs for the manufacture of drug product to support the commercial launch of those products.
Until the date at which regulatory approval has been received or is otherwise considered probable, all such costs are recorded as research and development expenses as incurred.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: Inventories are stated at the lower of cost and net realizable value, with cost determined in a manner that approximates the first-in, first-out method.
+Added: Inventories are stated at the lower of cost and net realizable value, with cost determined in a manner that approximates weighted average cost.
The Company periodically analyzes its inventory levels, and writes down inventory that has become obsolete, inventory that has a cost basis in excess of its estimated realizable value and inventory in excess of expected sales requirements as cost of product sales.
−Removed: The determination of whether inventory costs will be realizable requires estimates by management.
+Added: The determination of whether inventory costs will be realizable requires estimates of future prices 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.
8 unchanged sentences
• Convertible note instruments are recorded using the fair value option method of accounting.
−Removed: 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.
+Added: Accordingly, convertible note instruments are remeasured at fair value on a recurring basis, with any changes in the fair value option recorded in other income (expense), net.
• Public equity securities with readily determinable fair values are recorded at fair value.
−Removed: Subsequent changes in fair value are recorded in other (expense) income, net.
+Added: Subsequent changes in fair value are recorded in other income (expense), net.
Derivative financial instruments to purchase public equity securities are recorded at fair value.
The estimated fair value of derivative financial instruments is determined based on the Black-Scholes valuation model.
−Removed: Changes in fair value of derivative instruments are recorded in other (expense) income, net.
+Added: Changes in fair value of derivative instruments are recorded in other income (expense), net.
• Private equity securities without readily determinable fair values and where the Company does not have significant influence are measured at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.
−Removed: Adjustments to private equity securities are recorded in other (expense) income, net.
+Added: Adjustments to private equity securities are recorded in other income (expense), net.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
• Equity investments in common stock or in-substance common stock where the Company has significant influence over the financial and operating policies of the investee are accounted for as equity-method investments.
Equity-method investments are initially recorded at cost and subsequently adjusted based on the Company’s percentage ownership in the investee’s income and expenses, as well as dividends, if any.
−Removed: The Company records its share of the investee's results of operations in other (expense) income, net.
+Added: The Company records its share of the investee’s results of operations in other income (expense), net.
The Company records impairment losses on our equity method investments if it deems the impairment to be other-than-temporary.
3 unchanged sentences
The Company recognizes an allowance on available-for-sale debt securities when a portion of the unrealized loss is attributable to a credit loss and a corresponding credit loss in net income.
−Removed: No impairment losses or allowance for credit losses on investments were recorded for any periods presented.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
+Added: No allowance for credit losses were recorded for any periods presented.
+Added: The Company recognized an impairment loss of $ 7,529 related to its investments in equity during the year ended December 31, 2023.
+Added: No impairment losses on equity investments were recorded for the years ended December 31, 2022 and 2021.
Property, Plant and Equipment
23 unchanged sentences
Lease liabilities that become due within one year of the balance sheet date are classified as current liabilities.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Leases with an initial lease term of 12 months or less are not recorded on the consolidated balance sheet.
10 unchanged sentences
Guangzhou land use rights are being amortized over the respective terms of the land use rights, which are each 50 years.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: 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.
13 unchanged sentences
For the years ended December 31, 2023, 2022 and 2021 the Company determined that there were no indicators of impairment of goodwill.
+Added: While there were no impairments, the Company wrote off the goodwill associated with the acquisition of Celgene’s commercial operations in China to align with the terms of the Settlement Agreement.
Intangible assets acquired through business combinations are recognized as assets separate from goodwill and are measured at fair value upon acquisition.
1 unchanged sentence
Intangible assets associated with milestone payments made to third parties subsequent to regulatory approval are recorded at cost.
−Removed: 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;
−Removed: post-approval milestone payments under license and commercialization agreements, that are amortized over the remainder of the product patent or the term of the commercialization agreements;
+Added: Identifiable intangible assets consist of 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.
+Added: Distribution rights for approved cancer therapies licensed from BMS had been fully amortized through December 31, 2023, when the rights reverted back to BMS under the terms of the Settlement Agreement.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Intangible assets with finite useful lives are tested for impairment when events or circumstances occur that could indicate that the carrying amount of an asset may not be recoverable.
8 unchanged sentences
For the years ended December 31, 2023, 2022 and 2021, there was no impairment of the value of the Company’s long-lived assets.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Fair Value Measurements
14 unchanged sentences
The cost approach is based on the amount that would currently be required to replace an asset.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Financial instruments measured at fair value on a recurring basis
5 unchanged sentences
Money market funds 1,052,149 — —
+Added: Time deposits 42,852 — —
Short-term investments (Note 5):
Treasury securities 2,600 — —
+Added: Prepaid expenses and other current assets (Note 5):
+Added: Convertible debt instrument — — 4,668
Other non-current assets (Note 5):
1 unchanged sentence
Convertible debt instrument — — 4,215
−Removed: Prepaid expenses and other current assets (Note 6):
−Removed: Convertible debt instrument — — 5,190
Total 1,100,647 542 8,883
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
As of December 31, 2022 Quoted Price
2 unchanged sentences
Cash equivalents
−Removed: treasury securities 107,855 — —
Money market funds 758,114 — —
1 unchanged sentence
Treasury securities 665,251 — —
+Added: Prepaid expenses and other current assets (Note 5):
+Added: Convertible debt instrument — — 5,190
Other non-current assets (Note 5):
Equity securities with readily determinable fair values 3,307 706 —
+Added: Convertible debt instrument — — 3,000
Total 1,426,672 706 8,190
2 unchanged sentences
The Company determines the fair value of cash equivalents and available-for-sale debt securities using a market approach based on quoted prices in active markets.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
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.
3 unchanged sentences
Refer to Note 5, Investments for details of the determination of the carrying amount of private equity investments without readily determinable fair values and equity method investments.
−Removed: The Company holds convertible notes issued by two private biotech companies.
+Added: The Company holds convertible notes issued by private biotech companies.
The Company has elected the fair value option method of accounting for the convertible notes.
−Removed: Accordingly, the convertible notes are remeasured at fair value on a recurring basis using Level 3 inputs.
+Added: Accordingly, the convertible notes are remeasured at fair value on a recurring basis using Level 3 inputs, with any changes in the fair value option recorded in other income (expense), net.
+Added: The Company recorded a loss on fair value adjustment of $ 1,492 for the year ended December 31, 2023.
+Added: There were no fair value adjustments during the years ended December 31, 2022 and 2021.
As of December 31, 2023 and 2022, 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.
11 unchanged sentences
Once a contract is determined to be within the scope of ASC 606 at contract inception, the Company reviews the contract to determine which performance obligations it must deliver and which of these performance obligations are distinct.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: Company recognizes as revenue the amount of the transaction price that is allocated to each performance obligation when that performance obligation is satisfied or as it is satisfied.
+Added: The Company recognizes as revenue the amount of the transaction price that is allocated to each performance obligation when that performance obligation is satisfied or as it is satisfied.
Product Revenue
−Removed: The Company generates product revenues in China through the sale of its internally developed drugs tislelizumab, BRUKINSA and pamiparib, and the sale of in-licensed products through its agreements with Amgen, BMS, Bio-Thera and EUSA Pharma.
+Added: The Company generates product revenues in China through the sale of its internally developed drugs TEVIMBRA, BRUKINSA and PARTRUVIX, and the sale of in-licensed products through its agreements with Amgen, BMS, Bio-Thera, EUSA Pharma and Luye Pharmaceutical.
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.
−Removed: In the United States, the Company generates product revenues from the sale of BRUKINSA.
+Added: In the U.S., 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.
−Removed: In the United States, the Company distributes BRUKINSA through specialty pharmacies and specialty distributors.
+Added: In the U.S., 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.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
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.
16 unchanged sentences
For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and therefore within the scope of ASC 606.
−Removed: For elements of
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently.
+Added: For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently.
In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the five-step model under ASC 606 noted above.
5 unchanged sentences
Non-refundable payments received before all of the relevant criteria for revenue recognition are satisfied are recorded as advances from customers.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Licenses of Intellectual Property:
18 unchanged sentences
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
Research and Development Expenses
6 unchanged sentences
Revisions in the scope of a contract are charged to expense in the period in which the facts that give rise to the revision become reasonably certain.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The process of estimating the Company’s research and development expenses involves reviewing open contracts and purchase orders, communicating with its personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated costs incurred for the services when the Company has not yet been invoiced or otherwise notified of the actual costs.
6 unchanged sentences
The Company has acquired rights to develop and commercialize product candidates.
−Removed: 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.
+Added: Upfront payments that relate to the acquisition of a new drug compound, as well as pre-commercial milestone payments (prior to government approval), 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.
1 unchanged sentence
Government Grants
−Removed: Government financial incentives that involve no conditions or continuing performance obligations of the Company are recognized as other (expense) income, net upon receipt.
+Added: Government financial incentives that involve no conditions or continuing performance obligations of the Company are recognized as other income (expense), 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.
2 unchanged sentences
As of December 31, 2023 and 2022, other long-term liabilities related to the Guangzhou manufacturing facility build-out totaled $ 34,084 and $ 38,118 , respectively.
−Removed: For the year ended December 31, 2022, depreciation expense is presented net of amortization of government assistance of $ 3,169 .
+Added: For the years ended December 31, 2023 and 2022, depreciation expense is presented net of amortization of government assistance of $ 2,938 and $ 3,169 , respectively.
+Added: Government assistance received to support research and development programs was recorded as other long-term liabilities upon receipt and is recognized as other income (expense) , net when the associated research and development programs are completed.
+Added: As of December 31, 2023 and 2022, other long-term liabilities related to research and development programs totaled $ 120 and $ 58 , respectively.
+Added: For the years ended December 31, 2023 and 2022, the Company recognized other income of nil and $ 1,664 , respectively, upon the completion of a designated research and development program.
+Added: Comprehensive Loss
+Added: Comprehensive loss is defined as the changes in equity of the Company during a period from transactions and other events and circumstances excluding transactions resulting from investments by owners and distributions to owners.
+Added: Among other disclosures, ASC 220, Comprehensive Income , requires that all items that are required to be recognized under current accounting standards as components of comprehensive loss be reported in a financial statement that is displayed with the same prominence as other financial statements.
+Added: For each of the periods presented, the Company’s comprehensive loss includes net loss, foreign currency translation adjustments, pension liability adjustments and unrealized holding gains/losses associated with the available-for-sale debt securities, and is presented in the consolidated statements of comprehensive loss.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: 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.
−Removed: As of December 31, 2022 and 2021, other long-term liabilities related to research and development programs totaled $ 58 and $ 1,759 , respectively.
−Removed: 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.
−Removed: Comprehensive Loss
−Removed: Comprehensive loss is defined as the changes in equity of the Company during a period from transactions and other events and circumstances excluding transactions resulting from investments by owners and distributions to owners.
−Removed: Among other disclosures, ASC 220, Comprehensive Income , requires that all items that are required to be recognized under current accounting standards as components of comprehensive loss be reported in a financial statement that is displayed with the same prominence as other financial statements.
−Removed: For each of the periods presented, the Company’s comprehensive loss includes net loss, foreign currency translation adjustments, pension liability adjustments and unrealized holding gains/losses associated with the available-for-sale debt securities, and is presented in the consolidated statements of comprehensive loss.
Share-Based Compensation
22 unchanged sentences
Incremental compensation cost is measured as the excess, if any, of the fair value of the modified award over the fair value of the original award immediately before its terms are modified, measured based on the fair value of the awards and other pertinent factors at the modification date.
−Removed: For vested awards, the Company recognizes incremental compensation cost in the period the
+Added: For vested awards, the Company recognizes incremental compensation cost in the period the modification occurs.
+Added: For unvested awards, the Company recognizes over the remaining requisite service period, the sum of the incremental compensation cost and the remaining unrecognized compensation cost for the original award on the modification date.
+Added: If the fair value of the modified award is lower than the fair value of the original award immediately before modification, the minimum compensation cost the Company recognizes is the cost of the original award.
+Added: The Company uses the liability method of accounting for income taxes.
+Added: Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using enacted tax rates that will be in effect when the differences are expected to reverse.
+Added: A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: modification occurs.
−Removed: For unvested awards, the Company recognizes over the remaining requisite service period, the sum of the incremental compensation cost and the remaining unrecognized compensation cost for the original award on the modification date.
−Removed: If the fair value of the modified award is lower than the fair value of the original award immediately before modification, the minimum compensation cost the Company recognizes is the cost of the original award.
−Removed: The Company uses the liability method of accounting for income taxes.
−Removed: Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using enacted tax rates that will be in effect when the differences are expected to reverse.
−Removed: A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized.
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.
17 unchanged sentences
Concentration of Risks
−Removed: Concentration of credit risk
+Added: Concentration of cash and 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, 2023 and 2022, $ 3,171,800 and $ 3,869,564 were deposited with various major reputable financial institutions located in the PRC and international financial institutions outside of the PRC, respectively.
−Removed: The deposits placed with
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: financial institutions are not protected by statutory or commercial insurance.
+Added: The deposits placed with 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.
6 unchanged sentences
As of December 31, 2023 and 2022, the Company had accounts receivable, net of $ 358,027 and $ 173,168 , respectively.
−Removed: Accounts receivable, net represent amounts arising from product sales and amounts due from its collaboration partners.
+Added: Accounts receivable, net represent amounts arising from product sales.
The Company monitors economic conditions to identify facts or circumstances that may indicate receivables are at risk of collection.
−Removed: Customer concentration risk
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: For the year ended December 31, 2020, sales to the Company's two largest product distributors, China Resources and Sinopharm, represented approximately 38.7 % and 25.4 % of product revenue, respectively, and collectively, represented approximately 59.6 % of trade accounts receivable as of December 31, 2020.
−Removed: Business, customer, political, social and economic risks
−Removed: 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:
−Removed: changes in the overall demand for services and products;
−Removed: competitive pressures due to existing competitors and new entrants;
−Removed: advances and new trends in new drugs and industry standards;
−Removed: changes in clinical research organizations, contract manufacturers and other key vendors;
−Removed: changes in certain strategic relationships or customer relationships;
−Removed: regulatory considerations;
−Removed: intellectual property considerations;
−Removed: and risks associated with the Company’s ability to attract and retain employees necessary to support its growth.
−Removed: The Company’s operations could be also adversely affected by significant political, economic and social uncertainties in the PRC and in relations between the PRC and United States.
−Removed: Currency convertibility risk
−Removed: A significant portion of the Company’s expenses, assets and liabilities are denominated in RMB.
−Removed: 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).
−Removed: However, the unification of the exchange rates does not imply that the RMB may be readily convertible into U.S.
−Removed: dollar or other foreign currencies.
−Removed: All foreign exchange transactions continue to take place either through the PBOC or other banks authorized to buy and sell foreign currencies at the exchange rates quoted by the PBOC.
−Removed: Approvals of foreign currency payments by the PBOC or other institutions require submitting a payment application form together with suppliers’ invoices, shipping documents and signed contracts.
−Removed: Additionally, the value of the RMB is subject to changes in central government policies and international economic and political developments affecting supply and demand in the PRC foreign exchange trading system market.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: Foreign currency exchange rate risk
−Removed: The Company is exposed to foreign exchange risk arising from various currency exposures.
−Removed: The Company's reporting currency is the U.S.
−Removed: dollar, but a portion of its operating transactions and assets and liabilities are in other currencies, such as RMB, Euro, and Australian dollar.
−Removed: 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.
−Removed: RMB is not freely convertible into foreign currencies for capital account transactions.
−Removed: The value of RMB against the U.S.
−Removed: dollar and other currencies is affected by, among other things, changes in China’s political and economic conditions and China’s foreign exchange prices.
−Removed: Since July 21, 2005, the RMB is permitted to fluctuate within a narrow and managed band against a basket of certain foreign currencies.
−Removed: For RMB against U.S.
−Removed: 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.
−Removed: It is difficult to predict how market forces or PRC or U.S.
−Removed: government policy may impact the exchange rate between the RMB and the U.S.
−Removed: dollar in the future.
−Removed: To the extent that the Company needs to convert U.S.
−Removed: dollar into RMB for capital expenditures and working capital and other business purposes, appreciation of RMB against U.S.
−Removed: dollar would have an adverse effect on the RMB amount the Company would receive from the conversion.
−Removed: Conversely, if the Company decides to convert RMB into U.S.
−Removed: dollar for the purpose of making payments for dividends on ordinary shares, strategic acquisitions or investments or other business purposes, appreciation of U.S.
−Removed: dollar against RMB would have a negative effect on the U.S.
−Removed: dollar amount available to the Company.
−Removed: In addition, a significant depreciation of the RMB against the U.S.
−Removed: dollar may significantly reduce the U.S.
−Removed: dollar equivalent of the Company's foreign cash balances and trade receivables.
−Removed: Further, volatility in exchange rate fluctuations may have a significant impact on the foreign currency translation adjustments recorded in other comprehensive income (loss).
−Removed: The revaluation impact of foreign currencies held in U.S.
−Removed: functional currency subsidiaries may result in significant foreign exchange gains (losses) in the consolidated statement of operations.
−Removed: The Company has not used derivative financial instruments to hedge exposure to foreign exchange risk.
−Removed: Revision of prior period financial statements
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Accordingly, no valuation allowance was previously recorded related to those deferred tax assets.
−Removed: 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.
−Removed: The Company determined the previous conclusion to not apply a valuation allowance to certain net deferred tax assets was an error.
−Removed: In accordance with Staff Accounting Bulletin (SAB) No.
−Removed: 99, “Materiality,” and SAB No.
−Removed: 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.
−Removed: 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.
−Removed: A summary of revisions to previously reported financial statements is presented in Note 3, Revision of Prior Period Financial Statements.
−Removed: Note 12, Income Taxes and Note 16, Loss Per Share have been updated to
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: reflect the revision.
−Removed: The Company will also correct previously reported financial information for this error in its future filings, as applicable.
+Added: Customer concentration risk
+Added: For the year ended December 31, 2023, sales to the Company ’ s four largest product distributors, ASD Specialty Healthcare, McKesson, Sinopharm, and Shanghai Pharmaceutical, represented approximately 16.0 %, 14.2 %, 12.4 % and 11.4 % of product revenue, respectively, and collectively, represented approximately 53.2 % of trade accounts receivable as of December 31, 2023.
+Added: For the year ended December 31, 2023, the Company ’ s collaboration revenue consisted primarily of revenue recognized under its out-licensing collaboration agreements with Novartis.
+Added: For the year ended December 31, 2022, sales to the Company ’ s four largest product distributors, Sinopharm, Shanghai Pharmaceutical, ASD Specialty Healthcare and China Resources represented approximately 18.1 %, 15.5 %, 14.2 % and 12.1 % of product revenue, respectively, and collectively, represented approximately 57.0 % of trade accounts receivable as of December 31, 2022.
+Added: For the year ended December 31, 2022, the Company ’ s collaboration revenue consisted entirely of revenue recognized under its out-licensing collaboration agreements with Novartis.
+Added: For the year ended December 31, 2021, sales to the Company ’ s three largest product distributors, Sinopharm, China Resources, and Shanghai Pharmaceutical represented approximately 26.0 %, 19.9 % and 16.7 % of product revenue, respectively, and collectively, represented approximately 23.4 % of trade accounts receivable as of December 31, 2021.
+Added: For the year ended December 31, 2021, the Company ’ s collaboration revenue consisted entirely of revenue recognized under its out-licensing collaboration agreements with Novartis.
+Added: Receivables from Novartis represented approximately 66.4 % of trade accounts receivable as of December 31, 2021, primarily due to the invoicing of the $ 300,000 upfront fee related to the Ociperlimab option, collaboration and license agreement.
Recent Accounting Pronouncements
−Removed: New accounting standards which have been adopted
−Removed: In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832):
−Removed: Disclosures by Business Entities about Government Assistance.
−Removed: 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.
−Removed: This update is effective for annual periods beginning after December 15, 2021, and early application is permitted.
−Removed: This guidance should be applied either prospectively to all transactions that are reflected in financial statements at the date of initial application and new transactions that are entered into after the date of initial application or retrospectively to those transactions.
−Removed: The Company adopted this standard on January 1, 2022.
−Removed: The adoption of this standard has been applied to existing government assistance transactions.
−Removed: Revision of Prior Period Financial Statements
−Removed: 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).
−Removed: Specifically, a valuation allowance should have been recorded on all net deferred tax assets and such a valuation allowance was not previously recorded.
−Removed: 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.
−Removed: Consolidated Balance Sheet
−Removed: December 31, 2021
−Removed: As Reported Adjustments As Revised
−Removed: Deferred tax assets 110,424 ( 110,424 ) —
−Removed: Total non-current assets 1,032,069 ( 110,424 ) 921,645
−Removed: Total assets 8,645,949 ( 110,424 ) 8,535,525
−Removed: Accumulated deficit ( 4,966,103 ) ( 110,424 ) ( 5,076,527 )
−Removed: Total equity 6,242,987 ( 110,424 ) 6,132,563
−Removed: Total liabilities and equity 8,645,949 ( 110,424 ) 8,535,525
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: Consolidated Statements of Operations
−Removed: Year Ended December 31, Year Ended December 31,
−Removed: As Reported Adjustments As Revised As Reported Adjustments As Revised
−Removed: Income tax expense (benefit) ( 25,234 ) 44,462 19,228 ( 17,671 ) 28,068 10,397
−Removed: Net loss ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,600,523 ) ( 28,068 ) ( 1,628,591 )
−Removed: Net loss attributable to BeiGene, Ltd.
−Removed: ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,596,906 ) ( 28,068 ) ( 1,624,974 )
−Removed: Net loss per share attributable to BeiGene, Ltd., basic and diluted ( 1.17 ) ( 0.04 ) ( 1.21 ) ( 1.47 ) ( 0.03 ) ( 1.50 )
−Removed: Net loss per American Depositary Share ("ADS") ( 15.23 ) ( 0.48 ) ( 15.71 ) ( 19.13 ) ( 0.34 ) ( 19.47 )
−Removed: Consolidated Statements of Comprehensive Loss
−Removed: Year Ended December 31, Year Ended December 31,
−Removed: As Reported Adjustments As Revised As Reported Adjustments As Revised
−Removed: Net loss ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,600,523 ) ( 28,068 ) ( 1,628,591 )
−Removed: Comprehensive loss ( 1,402,346 ) ( 44,462 ) ( 1,446,808 ) ( 1,585,452 ) ( 28,068 ) ( 1,613,520 )
−Removed: Comprehensive loss attributable to BeiGene, Ltd.
−Removed: ( 1,402,346 ) ( 44,462 ) ( 1,446,808 ) ( 1,581,963 ) ( 28,068 ) ( 1,610,031 )
−Removed: Consolidated Statement of Cash Flows
−Removed: Year Ended December 31, Year Ended December 31,
−Removed: As Reported Adjustments As Revised As Reported Adjustments As Revised
−Removed: Operating activities:
−Removed: Net loss ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,600,523 ) ( 28,068 ) ( 1,628,591 )
−Removed: Adjustments to reconcile net loss to net cash used in operating activities:
−Removed: Deferred income tax expense ( 41,085 ) 44,462 3,377 ( 27,807 ) 28,068 261
−Removed: Net cash used in operating activities ( 1,298,723 ) — ( 1,298,723 ) ( 1,283,461 ) — ( 1,283,461 )
+Added: New accounting standards which have not yet been adopted
+Added: In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280):
+Added: Improvements to Reportable Segment Disclosures.
+Added: This update requires disclosure of incremental segment information on an annual and interim basis.
+Added: This update is effective for annual periods beginning after December 15, 2023, and interim periods within annual periods beginning after December 15, 2024.
+Added: Early adoption is permitted.
+Added: This guidance should be applied retrospectively to all prior periods presented in the financial statements.
+Added: The Company is currently evaluating the impact on its financial statements of adopting this guidance.
+Added: In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures.
+Added: This update requires that public entities on an annual basis, (1) in the rate reconciliation, disclose specific categories and provide additional information for reconciling items that meet a quantitative threshold;
+Added: (2) about income taxes paid, disclose the amount of income taxes paid (net of refunds received) disaggregated by federal, state, and foreign taxes and by individual jurisdiction in which income taxes paid (net of refunds received) is equal to or greater than 5 percent of total income taxes paid (net of refunds received);
+Added: and (3) disclose income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign and income tax expense (or benefit) disaggregated by federal, state, and foreign.
+Added: This update is effective for annual periods beginning after December 15, 2024.
+Added: Early adoption is permitted.
+Added: This guidance should be applied on a prospective basis.
+Added: Retrospective application is permitted.
+Added: The Company is currently evaluating the impact on its financial statements of adopting this guidance.
+Added: Collaborative and Licensing Arrangements
+Added: The Company enters into collaborative arrangements for the research and development, manufacture and/or commercialization of drug products and drug candidates.
+Added: To date, these collaborative arrangements have included out-licenses of and options to out-license internally developed products and drug candidates to other parties, in-licenses of products and drug candidates from other parties, and profit- and cost-sharing arrangements.
+Added: 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.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: Consolidated Statement of Stockholders' Equity
−Removed: Accumulated Deficit Total Equity
−Removed: As Reported Adjustments As Revised As Reported Adjustments As Revised
−Removed: Balance at December 31, 2019 ( 1,955,843 ) ( 37,894 ) ( 1,993,737 ) 978,355 ( 37,894 ) 940,461
−Removed: Net loss ( 1,596,906 ) ( 28,068 ) ( 1,624,974 ) ( 1,600,523 ) ( 28,068 ) ( 1,628,591 )
−Removed: Balance at December 31, 2020 ( 3,552,749 ) ( 65,962 ) ( 3,618,711 ) 3,869,243 ( 65,962 ) 3,803,281
−Removed: Net loss ( 1,413,354 ) ( 44,462 ) ( 1,457,816 ) ( 1,413,354 ) ( 44,462 ) ( 1,457,816 )
−Removed: Balance at December 31, 2021 ( 4,966,103 ) ( 110,424 ) ( 5,076,527 ) 6,242,987 ( 110,424 ) 6,132,563
−Removed: Collaborative and Licensing Arrangements
−Removed: The Company enters into collaborative arrangements for the research and development, manufacture and/or commercialization of drug products and drug candidates.
−Removed: To date, these collaborative arrangements have included out-licenses of 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.
−Removed: 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
7 unchanged sentences
Right to access intellectual property revenue 104,477 104,994 3,979
+Added: Material rights revenue 71,980 — —
Other 13,039 9,493 —
2 unchanged sentences
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”).
−Removed: 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.
−Removed: In addition, both companies may conduct clinical trials globally to explore combinations of tislelizumab with other cancer treatments, and the Company has an option to co-detail the product in North America, funded in part by Novartis.
+Added: The Company and Novartis agreed to jointly develop tislelizumab in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals.
+Added: In addition, both companies had the ability to 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.
−Removed: The Company is eligible to receive up to $ 1,300,000 upon the achievement of regulatory milestones, $ 250,000 upon the achievement of sales milestones, and royalties on future sales of tislelizumab in the licensed territory.
−Removed: Under the terms of the agreement, the Company is responsible for funding ongoing clinical trials of tislelizumab, Novartis has agreed to fund new registrational, bridging, or post-marketing studies in its territory, and each party will be responsible for funding clinical trials evaluating tislelizumab in
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: combination with its own or third party products.
−Removed: Each party retains the worldwide right to commercialize its propriety products in combination with tislelizumab.
+Added: The Company was eligible to receive up to $ 1,300,000 upon the achievement of regulatory milestones, $ 250,000 upon the achievement of sales milestones, and royalties on future sales of tislelizumab in the licensed territory.
+Added: Under the terms of the agreement, the Company was responsible for funding ongoing clinical trials of tislelizumab, Novartis agreed to fund new registrational, bridging, or post-marketing studies in its territory, and each party was responsible for funding clinical trials evaluating tislelizumab in combination with its own or third party products.
+Added: Each party retained 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.
3 unchanged sentences
and (3) supplying Novartis with required quantities of the tislelizumab drug product, or drug substance, upon receipt of an order from Novartis.
−Removed: 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.
−Removed: 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.
−Removed: The Company evaluated the supply component of the contract and noted the supply will not be provided at a significant incremental discount to Novartis.
+Added: The Company determined that the license, transfer of know-how and use of trademarks were not distinct from each other and represented a single performance obligation.
+Added: The tislelizumab R&D services represented a material promise and were determined to be a separate performance obligation at the outset of the agreement as the promise was distinct and had standalone value to Novartis.
+Added: The Company evaluated the supply component of the contract and noted the supply was not 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.
−Removed: A performance obligation for the clinical and commercial supply will be established as quantities of drug product or drug substance are ordered by Novartis.
+Added: A performance obligation for the clinical and commercial supply would be established as quantities of drug product or drug substance are ordered by Novartis.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The Company determined that the transaction price as of the outset of the arrangement was the upfront payment of $ 650,000 .
−Removed: The potential milestone payments that the Company is eligible to receive were excluded from the transaction price, as all milestone amounts were fully constrained due to uncertainty of achievement.
+Added: The potential milestone payments that the Company was 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.
2 unchanged sentences
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.
−Removed: The estimates of the standalone selling prices involved management's key assumptions such as revenue growth rate, estimated clinical trial costs, mark-up rate, probability of technical and regulatory success, and discount rates.
−Removed: These significant assumptions are forward looking and could be affected by future economic, regulatory and market conditions.
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.
−Removed: 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.
−Removed: Estimated costs to complete are reassessed on a periodic basis and any updates to the revenue earned are recognized on a prospective basis.
−Removed: The Company recognized R&D service revenue of $ 39,655 and $ 53,421 during the years ended December 31, 2022 and 2021, respectively.
−Removed: The Company also recognized other collaboration revenue of $ 9,493 related to the sale of tislelizumab clinical supply to Novartis in conjunction with the collaboration during the years ended December 31, 2022.
+Added: The portion of the transaction price allocated to the R&D services was deferred and was being recognized as collaboration revenue as the R&D services were performed using a percentage-of-completion method.
+Added: Estimated costs to complete were reassessed on a periodic basis and any updates to the revenue earned were recognized on a prospective basis.
+Added: In September 2023, the Company and Novartis agreed to mutually terminate the collaboration and license agreement, effective immediately.
+Added: Pursuant to the termination agreement, the Company regained full, global rights to develop, manufacture and commercialize tislelizumab with no royalty payments due to Novartis.
+Added: Novartis may continue its ongoing clinical trials and has the ability to conduct future combination trials with tislelizumab subject to BeiGene’s approval.
+Added: BeiGene agreed to provide Novartis with ongoing clinical supply of tislelizumab to support its clinical trials.
+Added: Pursuant to the termination agreement, Novartis agreed to provide transition services to the Company to enable key aspects of the tislelizumab development and commercialization plan to proceed without disruption, including manufacturing, regulatory, safety and clinical support.
+Added: Upon termination of the agreement in September 2023, there were no further performance obligations, and the remaining deferred revenue balance associated with the tislelizumab R&D services was recognized in full.
+Added: The following table summarizes collaboration revenue recognized in connection with the tislelizumab collaboration and license agreement for the years ended December 31, 2023, 2022 and 2021:
+Added: Year Ended December 31,
+Added: 2023 2022 2021
+Added: License revenue — — 484,646
+Added: Research and development service revenue 72,278 39,655 53,421
+Added: 5,067 9,493 —
+Added: Total 77,345 49,148 538,067
+Added: (1) Represents revenue recognized on sale of tislelizumab clinical supply to Novartis in conjunction with the collaboration.
Ociperlimab Option, Collaboration and License Agreement and China Broad Market Development Agreement
1 unchanged sentence
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.
−Removed: Under the terms of the option, collaboration and license agreement, the Company received an upfront cash payment of $ 300,000 in January 2022 from Novartis and will receive an additional payment of $ 600,000 or $ 700,000 in the event Novartis exercises its exclusive time-based option prior to mid-2023 or between then and late-2023, respectively.
−Removed: Following option
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: 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.
−Removed: 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.
−Removed: Following the option exercise, Novartis has agreed to share development costs of global trials.
−Removed: 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.
−Removed: 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.
−Removed: The existing tislelizumab collaboration and license agreement was not modified as a result of the ociperlimab option, collaboration and license agreement.
+Added: Under the terms of the option, collaboration and license agreement, the Company received an upfront cash payment of $ 300,000 in January 2022 from Novartis and would have received an additional payment of $ 600,000 or $ 700,000 in the event Novartis exercised its exclusive time-based option prior to mid-2023 or between then and late-2023, respectively.
+Added: Following option exercise, the Company would have been eligible to receive up to $ 745,000 upon the achievement of regulatory approval milestones, $ 1,150,000 upon the achievement of sales milestones, and royalties on future sales of ociperlimab in the Novartis Territory.
+Added: Subject to the terms of the option, collaboration and license agreement, during the option period, Novartis had agreed to initiate and fund additional global clinical trials with ociperlimab and the Company has agreed to expand enrollment in two ongoing trials.
+Added: Following the option exercise, Novartis had agreed to share development costs of global trials.
+Added: Following approval, the Company had agreed to provide 50 percent of the co-detailing and co-field medical efforts in the U.S., and had an option to co-detail up to 25 percent in Canada and Mexico, funded in part by Novartis.
+Added: Each party retained the worldwide right to commercialize its propriety products in combination with ociperlimab, as was the case with tislelizumab under the tislelizumab 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.
5 unchanged sentences
The market development activities are considered immaterial in the context of the contracts.
−Removed: 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.
−Removed: 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.
−Removed: The R&D Services represent a material promise and were determined to be a separate performance obligation at the outset of the agreement as the promise is distinct and has standalone value to Novartis.
+Added: The Company concluded that, at the inception of the agreement, the option for the exclusive product license constitutes a material right as it represented 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 was therefore considered a distinct performance obligation.
+Added: The Company determined that Novartis’ right to access ociperlimab in its own trials over the option period and the initial transfer of know-how were not distinct from each other, as the right to access ociperlimab had limited value without the corresponding know-how transfer, and therefore should be combined into one distinct performance obligation.
+Added: The R&D Services represented 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 .
−Removed: The option exercise fee is contingent upon Novartis exercising its right and is considered fully constrained until the option is exercised.
−Removed: Additionally, the milestone and royalty payments are not applicable until after the option is exercised, at which point the likelihood of meeting milestones, regulatory approval and meeting certain sales thresholds will be assessed.
+Added: The option exercise fee was contingent upon Novartis exercising its right and was considered fully constrained until the option is exercised.
+Added: Additionally, the milestone and royalty payments were 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.
3 unchanged sentences
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.
−Removed: The Company will satisfy the material right performance obligation at a point in time at the earlier of when Novartis exercises the option and the license is delivered or the expiration of the option period.
+Added: The Company would have satisfied the material right performance obligation at a point in time at the earlier of when Novartis exercised the option and the license was delivered or the expiration of the option period.
As such, the entire amount of the transaction price allocated to the material right was deferred.
−Removed: 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.
−Removed: The portion of the transaction price allocated to the R&D Services was deferred and is being recognized as collaboration revenue as the R&D Services are performed over the expected option period.
−Removed: The Company recognized collaboration revenue of $ 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.
+Added: The portion of the transaction price allocated to Novartis’ right to access ociperlimab in its own clinical trials during the option period and the initial transfer of BeiGene know-how was deferred and was recognized over the expected option period.
+Added: The portion of the transaction price allocated to the R&D Services was deferred and was recognized as collaboration revenue as the R&D Services were performed over the expected option period.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: In July 2023, the Company and Novartis mutually agreed to terminate the ociperlimab option, collaboration and license agreement, effective immediately.
+Added: Pursuant to the termination agreement, the Company regained full, global rights to develop, manufacture and commercialize ociperlimab.
+Added: Upon termination the Company had no further performance obligations under the collaboration, and all remaining deferred revenue balances were recognized in full.
+Added: The China broad markets agreement remains in place.
+Added: The following table summarizes collaboration revenue recognized in connection with the ociperlimab option, collaboration and license agreement for the years ended December 31, 2023, 2022 and 2021:
+Added: Year Ended December 31,
+Added: 2023 2022 2021
+Added: Research and development service revenue 7,153 7,167 250
+Added: Right to access intellectual property revenue 104,477 104,994 3,979
+Added: Material rights revenue 71,980 — —
+Added: Total 192,469 112,161 4,229
+Added: (2) Represents revenue generated under the broad markets marketing and promotion agreement in conjunction with the collaboration.
In-Licensing Arrangements - Commercial
18 unchanged sentences
The Company is also entitled to receive royalties from global sales of each product outside of China (with the exception of AMG 510).
−Removed: 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.
−Removed: 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.
−Removed: 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;
−Removed: and (ii) cooperate in good faith to prepare a transition plan with the anticipated termination of AMG 510 from the Collaboration Agreement.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: On April 20, 2022, the parties entered into the First Amendment to Amgen Collaboration Agreement, which amends certain terms and conditions relating to the financial responsibilities of the parties in connections with the development and commercialization of certain Amgen proprietary products for the treatment of oncology-related diseases and conditions.
+Added: In connection with the Company’s ongoing assessment of the Amgen Collaboration Agreement cost-share contributions, the Company determined that further investment in the development of LUMAKRAS was no longer commercially viable for BeiGene.
+Added: As a result, in February 2023, the Company and Amgen entered into the Second Amendment to the Amgen Collaboration Agreement to (i) stop sharing costs with Amgen for the further development of LUMAKRAS during the period starting January 1, 2023 and ending August 31, 2023;
+Added: and (ii) cooperate in good faith to prepare a transition plan with the termination of LUMAKRAS from the Amgen Collaboration Agreement.
The Amgen Collaboration Agreement is within the scope of ASC 808, as both parties are active participants and are exposed to the risks and rewards dependent on the commercial success of the activities performed under the agreement.
8 unchanged sentences
Per the SPA, the cash proceeds shall be used as necessary to fund the Company’s development obligations under the Amgen Collaboration Agreement.
−Removed: Pursuant to the SPA, Amgen also received the right to designate one member of the Company's board of directors, and Anthony
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: Hooper joined the Company's board of directors as the Amgen designee in January 2020.
+Added: Pursuant to the SPA, Amgen also received the right to designate one member of the Company’s board of directors, and Anthony Hooper joined the Company’s board of directors as the Amgen designee in January 2020.
Amgen relinquished its right to appoint a designated director to the Company’s board of directors in January 2023.
−Removed: 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.
5 unchanged sentences
The cost share liability is being amortized proportionately as the Company contributes cash and development services to its total co-development funding cap.
−Removed: Amounts recorded related to the cash proceeds received from the Amgen collaboration for the year ended December 31, 2020 were as follows:
−Removed: Year Ended December 31, 2020
−Removed: Fair value of equity issued to Amgen 2,162,407
−Removed: Fair value of research and development cost share liability 616,834
−Removed: 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, 2023, 2022 and 2021 were as follows:
6 unchanged sentences
Remaining portion of development funding cap 483,651
−Removed: As of December 31, 2022 and 2021, the research and development cost share liability recorded in the Company's balance sheet was as follows:
−Removed: As of December 31,
−Removed: Research and development cost share liability, current portion 114,335 120,801
−Removed: Research and development cost share liability, non-current portion 179,625 269,561
−Removed: Total research and development cost share liability 293,960 390,362
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: The net reimbursement due under the commercial profit-sharing agreement for in-line product sales is classified in the consolidated statements of operations for the three years ended December 31, 2022 as follows:
+Added: As of December 31, 2023 and 2022, the research and development cost share liability recorded in the Company’s balance sheet was as follows:
+Added: As of December 31,
+Added: Research and development cost share liability, current portion 68,004 114,335
+Added: Research and development cost share liability, non-current portion 170,662 179,625
+Added: Total research and development cost share liability 238,666 293,960
+Added: The net reimbursement paid 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, 2023 as follows:
Year Ended December 31,
20 unchanged sentences
Total 71,165 74,165 141,894
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Our significant license agreements are described below:
+Added: Ensem Therapeutics, Inc.
+Added: In November 2023, the Company entered into an exclusive global license to an Investigational New Drug application-ready oral cyclin-dependent kinase 2 inhibitor with Ensem Therapeutics, Inc.
+Added: Under the terms of the agreement, Ensem received an upfront payment of $ 30,000 in January 2024 and will be eligible for additional payments upon the achievement of certain development, regulatory, and commercial milestones, totaling up to $ 1,300,000 in addition to tiered royalties.
+Added: The upfront payment was expensed to research and development expense during the year ended December 31, 2023 in accordance with the Company’s acquired in-process research and development expense policy.
Shandong Luye Pharmaceutical Co., Ltd.
2 unchanged sentences
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.
−Removed: Luye is also eligible to receive future milestone payments upon achievement of certain regulatory milestones.
−Removed: Luye is also eligible to receive tiered royalties on net sales.
+Added: Luye is also eligible to receive future milestone payments upon achievement of certain regulatory milestones and 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.
+Added: The Company capitalized regulatory milestones of $ 19,365 related to the Luye collaboration during the year ended December 31, 2023.
Shoreline Biosciences, Inc.
In June 2021, the Company entered into an exclusive worldwide strategic collaboration with Shoreline Biosciences, Inc.
−Removed: (Shoreline) to develop and commercialize a portfolio of natural killer (NK)-based cell therapeutics with Shoreline's induced pluripotent stem cells (iPSC) NK cell technology and the Company's research and clinical development capabilities for different malignancies.
−Removed: Under the collaboration, the Company and Shoreline are working jointly to develop cell therapies for four
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: designated therapeutic targets, with an option to expand the collaboration at a future date.
−Removed: Clinical development is being led by the Company globally, with Shoreline responsible for clinical manufacturing.
−Removed: The Company has commercial rights globally, with Shoreline having an option to retain commercialization rights in the United States and Canada for two targets.
−Removed: Under the terms of the agreement, Shoreline received a $ 45,000 upfront payment in January 2022 and is eligible to receive additional R&D funding, milestone payments and royalties based upon the achievement of certain development, regulatory, and commercial milestones.
+Added: (“Shoreline”) to develop and commercialize a portfolio of natural killer (“NK”)-based cell therapeutics with Shoreline's induced pluripotent stem cells NK cell technology and the Company’s research and clinical development capabilities for different malignancies.
+Added: Under the collaboration, the Company and Shoreline were working jointly to develop cell therapies for four designated therapeutic targets, with an option to expand the collaboration at a future date.
+Added: Clinical development was being led by the Company globally, with Shoreline responsible for clinical manufacturing.
+Added: The Company had commercial rights globally, with Shoreline having an option to retain commercialization rights in the U.S.
+Added: and Canada for two targets.
+Added: Under the terms of the agreement, Shoreline received a $ 45,000 upfront payment in January 2022 and was 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.
+Added: The Company and Shoreline terminated the collaboration effective in the first quarter of 2024.
Nanjing Leads Biolabs, Inc.
4 unchanged sentences
The upfront payment was expensed to research and development expense during the year ended December 31, 2021 in accordance with the Company’s acquired in-process research and development expense policy.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
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.
10 unchanged sentences
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.
−Removed: BeiGene is responsible for development, regulatory submissions, and commercialization in China.
+Added: BeiGene was responsible for development, regulatory submissions, and commercialization in China.
Assembly retains full worldwide rights outside of the partnered territory for its HBV portfolio.
−Removed: 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 .
−Removed: Assembly is also eligible to receive tiered royalties on net sales.
+Added: Assembly received an upfront payment of $ 40,000 and was eligible to receive payments upon achievement of development, regulatory and commercial milestones up to a total of $ 503,750 .
+Added: Assembly was 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.
+Added: The Company received a termination notice from Assembly in December 2023.
Bio-Thera Solutions, Ltd.
6 unchanged sentences
Bio-Thera received an upfront payment of $ 20,000 in October 2020 and is eligible to receive payments upon the achievement of regulatory and commercial milestones up to a total of $ 145,000 .
−Removed: The upfront payment was expensed to research and
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: development expense during the year ended December 31, 2020 in accordance with the Company's acquired in-process research and development expense policy.
+Added: The upfront payment was expensed to research and development expense during the year ended December 31, 2020 in accordance with the Company’s acquired in-process research and development expense policy.
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.
+Added: In December 2023, the Company capitalized a commercial milestone of $ 5,000 .
In addition to the collaborations discussed above, the Company has entered into additional collaborative arrangements during the years ended December 31, 2023, 2022 and 2021.
3 unchanged sentences
The payment of these amounts, however, is contingent upon the occurrence of various future events, which have a high degree of uncertainty of occurrence.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Restricted Cash
−Removed: 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.
+Added: The Company’s restricted cash 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.
−Removed: 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.
+Added: Restricted cash as of December 31, 2023 and 2022 was as follows:
+Added: As of December 31,
+Added: Short-term restricted cash 11,473 196
+Added: Long-term restricted cash 2,711 5,277
+Added: Total 14,184 5,473
+Added: In addition to the restricted cash balances above, the Company is required by the PRC securities law to use the proceeds from the STAR offering in strict compliance with the planned uses as disclosed in the PRC offering prospectus as well as those disclosed in the Company’s proceeds management policy approved by the board of directors.
+Added: As of December 31, 2023, the Company had cash remaining related to the STAR Offering proceeds of $ 1,191,583 .
Short-Term Investments
22 unchanged sentences
Leap Therapeutics, Inc.
−Removed: In January 2020, the Company purchased $ 5,000 of Series B mandatorily convertible, non-voting preferred stock of Leap in connection with a strategic collaboration and license agreement the Company entered into with Leap.
+Added: In January 2020, the Company purchased $ 5,000 of Series B mandatorily convertible, non-voting preferred stock of Leap Therapeutics, Inc.
+Added: (“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.
2 unchanged sentences
Inclusive of the shares of common stock issuable upon the exercise of the currently exercisable warrants, the Company’s interest is approximately 4.7 %.
−Removed: 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.
−Removed: 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.
+Added: The Company measures the investment in the common stock and warrants at fair value, with changes in fair value recorded to other income (expense), net.
+Added: The following table summarizes unrealized (losses) gains recognized on the Company’s investment in Leap:
+Added: Year Ended December 31,
+Added: 2023 2022 2021
+Added: Other income (expense), net
+Added: ( 425 ) ( 30,102 ) 9,386
As of December 31, 2023 and 2022, the fair value of the common stock and warrants was as follows:
6 unchanged sentences
The Company held investments of $ 55,860 and $ 57,054 in equity securities without readily determinable fair values as of December 31, 2023 and 2022, respectively.
−Removed: 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.
−Removed: There were no adjustments to the carrying values of these securities for the years ended December 31, 2021 and 2020.
+Added: The following table summarizes unrealized (losses) gains recognized on the Company’s investment in equity securities without readily determinable fair values:
+Added: Year Ended December 31,
+Added: 2023 2022 2021
+Added: Other income (expense), net
+Added: ( 6,448 ) 5,065 —
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.
−Removed: 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.
−Removed: 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.
−Removed: The Company’s inventory balance consisted of the following:
−Removed: As of December 31,
−Removed: Raw materials 88,957 78,140
−Removed: Work in process 20,886 9,397
−Removed: Finished goods 172,503 155,089
−Removed: Total inventories 282,346 242,626
+Added: The Company holds equity-method investments totaling $ 25,981 and $ 27,710 as of December 31, 2023 and 2022, respectively.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: Manufacturing Facility in Guangzhou, China
−Removed: Manufacturing legal entity structure
−Removed: BeiGene Shanghai, originally established as a wholly-owned subsidiary of BeiGene (Hong Kong) Co., Ltd.
−Removed: (BeiGene HK), and currently a wholly-owned subsidiary of BeiGene Biologics, as described below, provides clinical development services for BeiGene affiliates and is the clinical trial authorization (CTA) holder and marketing authorization application (MAA) holder for tislelizumab in China.
−Removed: In March 2017, BeiGene HK, a wholly owned subsidiary of the Company, and Guangzhou GET Technology Development Co., Ltd.
−Removed: (now Guangzhou High-tech Zone Technology Holding Group Co., Ltd.) (GET), entered into a definitive agreement to establish a commercial scale biologics manufacturing facility in Guangzhou, Guangdong Province, PRC.
−Removed: BeiGene HK and GET entered into an Equity Joint Venture Contract (the “JV Agreement”).
−Removed: 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.
−Removed: GET made a cash capital contribution of RMB 100,000 to BeiGene Biologics, representing a 5 % equity interest in BeiGene Biologics.
−Removed: In addition, on March 7, 2017, BeiGene Biologics entered into a contract with GET, under which GET agreed to provide a RMB 900,000 loan (the "Shareholder Loan”) to BeiGene Biologics.
−Removed: 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.
−Removed: (BeiGene Guangzhou Factory), to manufacture biologics for the Company and its subsidiaries.
−Removed: 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.
−Removed: Upon the transfer of equity in BeiGene Shanghai, BeiGene HK's equity interest in BeiGene Shanghai became 95 %.
−Removed: In September 2020, BeiGene HK entered into a share purchase agreement (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 ).
−Removed: The transaction was finalized in November 2020 upon completion of the business registration filing.
−Removed: The share purchase was recorded as an equity transaction.
−Removed: The carrying amount of the noncontrolling interest balance of $ 9,116 was adjusted to nil to reflect the increase in BeiGene HK’s ownership interest to 100 %, and the difference in the fair value of the consideration paid and the carrying amount of the noncontrolling interest of $ 19,599 was recorded to additional paid in capital.
−Removed: In connection with the JV Share Purchase Agreement, BeiGene Biologics repaid the outstanding principal of the Shareholder Loan of $ 132,061 (RMB 900,000 ) and accrued interest of $ 36,558 (RMB 249,140 ).
−Removed: In connection with the JV share purchase, the Company entered into a loan agreement with China Minsheng Bank for a total loan facility of up to $ 200,000 (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.
−Removed: The Company may extend the original maturity date for up to two additional twelve month periods.
−Removed: In October 2020, the Company drew down $ 80,000 of the working capital facility and $ 118,320 of the acquisition facility to be used for the JV share repurchase.
−Removed: On October 9, 2021, the Company repaid $ 198,320 and drew down $ 200,000 from the Senior Loan .
−Removed: In addition, the Company entered into a loan agreement with Zhuhai Hillhouse Zhaohui Equity Investment Partnership (Zhuhai Hillhouse) for a total loan facility of $ 73,640 (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.
−Removed: 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.
−Removed: See Note 14 for further discussion of the loans.
−Removed: The Company has operating leases for office and manufacturing facilities in the United States, Switzerland, and China.
−Removed: The leases have remaining lease terms of up to five years , some of which include options to extend the leases that have not been included in the calculation of the Company’s lease liabilities and ROU assets.
+Added: The following table summarizes losses recognized on the Company’s equity-method investments:
+Added: Year Ended December 31,
+Added: 2023 2022 2021
+Added: Other income (expense), net
+Added: ( 7,856 ) ( 3,682 ) ( 1,796 )
+Added: Inventories, Net
+Added: The Company’s inventories, net consisted of the following:
+Added: As of December 31,
+Added: Raw materials 148,772 88,957
+Added: Work in process 39,098 20,886
+Added: Finished goods 228,252 172,503
+Added: Total inventories 416,122 282,346
+Added: The Company has operating leases for office and manufacturing facilities in the U.S., Switzerland, and China.
+Added: The leases have remaining lease terms of up to six 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.
−Removed: The land use rights represent lease prepayments and are expensed over the remaining term of
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: the rights, which is 50 years for the Guangzhou land use rights, 36 years for the Changping land use right, and 30 years for the Suzhou land use rights.
+Added: The land use rights represent lease prepayments and are expensed over the remaining term of the rights, which is 50 years for the Guangzhou land use rights, 36 years for the Changping land use right, and 30 years for the Suzhou land use rights.
The Company also has certain leases with terms of 12 months or less for certain equipment, office and lab space, which are expensed and not recorded on the balance sheet.
6 unchanged sentences
Total lease cost 33,762 34,071 29,251
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Supplemental balance sheet information related to leases was as follows:
12 unchanged sentences
Year ending December 31, 2028 1,682
+Added: Thereafter 932
Total lease payments 49,156
28 unchanged sentences
Property, plant and equipment, net 1,324,154 845,946
−Removed: In November 2021, the Company purchased a 42 -acre site located in Hopewell, NJ for $ 75,197 .
−Removed: The total purchase price was allocated between the land and an existing building on the property based on their relative fair values.
−Removed: The Company is constructing a biologics manufacturing facility and research and development center on the land.
Construction in progress (“CIP”) a s of December 31, 2023 and 2022 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.
8 unchanged sentences
Intangible Assets
−Removed: Intangible assets as of December 31, 2022 and December 31, 2021 are summarized as follows:
+Added: Intangible assets as of December 31, 2023 and 2022 are summarized as follows:
December 31, 2023 December 31, 2022
5 unchanged sentences
Finite-lived intangible assets:
−Removed: Product distribution rights 7,500 ( 4,000 ) 3,500 7,500 ( 3,250 ) 4,250
Developed products 64,274 ( 7,807 ) 56,467 41,235 ( 4,119 ) 37,116
−Removed: Trading license 816 ( 816 ) — 816 ( 816 ) —
+Added: Other 8,987 ( 8,316 ) 671 8,316 ( 4,816 ) 3,500
Total finite-lived intangible assets 73,261 ( 16,123 ) 57,138 49,551 ( 8,935 ) 40,616
+Added: Developed products represent post-approval milestone payments under license and commercialization agreements.
+Added: The Company is amortizing the developed products over the remainder of the respective product patent or the term of the commercialization agreements.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: Product distribution rights consist of distribution rights for the approved cancer therapies licensed from BMS as part of the BMS collaboration.
−Removed: The Company is amortizing the product distribution rights, as a single identified asset, over the term of the license agreement of 10 years from the date of acquisition.
−Removed: Developed products represent the post-approval milestone payments under license and commercialization agreements.
−Removed: The Company is amortizing the developed products over the remainder of the respective product patent or the term of the commercialization agreements.
−Removed: Trading license represents the Guangzhou drug distribution license acquired in September 2018.
−Removed: The Company amortized the drug distribution trading license over the remainder of the initial license term through February 2020.
−Removed: 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.
−Removed: Amortization expense for product distribution rights and trading licenses is included in operating expenses in the accompanying consolidated statements of operations.
+Added: Amortization expense for other intangible assets 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.
3 unchanged sentences
Amortization expense - Cost of sales - product
+Added: 3,739 3,225 965
Amortization expense - Operating expense
+Added: 3,500 751 750
Total 7,239 3,976 1,715
11 unchanged sentences
2023 2022 2021
−Removed: PRC ( 583,610 ) ( 606,752 ) ( 369,066 )
117,446 67,744 34,923
+Added: PRC ( 315,852 ) ( 583,610 ) ( 606,752 )
Other ( 627,430 ) ( 1,445,171 ) ( 866,759 )
10 unchanged sentences
Current Tax Expense (Benefit):
−Removed: PRC 27,905 15,252 16,121
25,170 4,844 ( 9 )
+Added: PRC 24,956 27,905 15,252
Other 5,059 6,547 805
9 unchanged sentences
Loss before tax ( 825,836 ) ( 1,961,037 ) ( 1,438,588 )
−Removed: China statutory tax rate 25 % 25 % 25 %
−Removed: Expected taxation at China statutory tax rate ( 490,259 ) ( 359,647 ) ( 404,549 )
+Added: statutory tax rate 21 % 21 % 21 %
+Added: Expected taxation at U.S.
+Added: statutory tax rate ( 173,426 ) ( 411,818 ) ( 302,103 )
Foreign and preferential tax rate differential 141,902 209,692 128,330
1 unchanged sentence
Stock compensation expenses 32,581 33,872 ( 27,411 )
−Removed: Effect of tax rate change — — ( 3,827 )
+Added: State tax expense (benefit) ( 3,464 ) 1,375 ( 3,187 )
Change in valuation allowance 845,811 229,550 254,768
+Added: Tax relief credits ( 704,928 ) — —
Research tax credits and incentives ( 64,343 ) ( 42,844 ) ( 31,530 )
+Added: Foreign-derived intangible income ( 37,395 ) ( 6,272 ) —
Taxation for the year 55,872 42,778 19,228
9 unchanged sentences
2023 2022 2021
−Removed: Deferred tax assets (liabilities):
Accruals and reserves 106,708 97,896 84,766
2 unchanged sentences
Research tax credits 68,117 86,000 82,060
+Added: Tax relief credits 704,928 — —
Depreciable and amortizable assets 687,600 798,563 937,069
6 unchanged sentences
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.
−Removed: 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.
−Removed: For the years ended December 31, 2022 and 2021 , there were increases in the valuation allowance of $ 229,550 and $ 254,768 , respectively.
+Added: After consideration of all positive and negative evidence, the Company believes that as of December 31, 2023, it is more likely than not that net deferred tax assets will not be realized.
Adjustments may be required in the future if the Company estimates that the amount of deferred tax assets to be realized is more or less than the net amount recorded.
+Added: The valuation allowances for the years ended December 31, 2023, 2022 and 2021 were as follows:
+Added: Year Ended December 31,
+Added: 2023 2022 2021
+Added: Beginning balance, as of January 1 1,943,775 1,758,409 1,200,547
+Added: Additions/(subtractions) charged to income tax provision 845,811 229,550 254,768
+Added: Additions/(subtractions) charged to equity — — 263,632
+Added: Currency translation and other ( 18,116 ) ( 44,184 ) 39,462
+Added: Ending balance, as of December 31 2,771,470 1,943,775 1,758,409
As of December 31, 2023 and 2022 , the Company had net operating losses of approximately $ 5,945,753 and $ 5,077,247 , respectively.
2 unchanged sentences
$ 4,088,658 derived from Switzerland which expires in years 2025 through 2030;
−Removed: and, $ 26,079 derived from entities in the United States that have an indefinite carryforward.
+Added: and, $ 2,047 derived from entities in the U.S.
+Added: that have an indefinite carryforward.
The Company has approximately $ 76,794 of U.S.
−Removed: research tax credits which will expire between 2036 and 2042, if not utilized.
+Added: research tax credits which will expire between 2036 and 2043 and approximately $ 704,928 of Switzerland tax relief credits which will expire in 2028, if not utilized.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The gross unrecognized tax benefits for the years ended December 31, 2023, 2022 and 2021 were as follows:
11 unchanged sentences
The Company does not anticipate that the amount of existing unrecognized tax benefits will significantly change within the next 12 months.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
The Company has elected to record interest and penalties related to income taxes as a component of income tax expense.
4 unchanged sentences
states and other non-US tax jurisdictions in which the Company files tax returns remain open to examination for 2013 through 2023.
−Removed: 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.
+Added: The Company qualifies for the Technology Advanced Service Enterprises and High and New Technology Enterprise 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, 2023 is approximately $ 3,092 , or less than $ 0.01 per share outstanding.
3 unchanged sentences
Supplemental Balance Sheet Information
−Removed: Changes in the allowance for credit losses related to trade accounts receivable consist of the following:
−Removed: Year Ended December 31,
−Removed: 2022 2021 2020
−Removed: Beginning balance, as of January 1 415 112 —
−Removed: Provision charged to selling, general and administrative expenses ( 219 ) 309 109
−Removed: Amounts written-off, net of recoveries of amounts previously reserved 1 — —
−Removed: Exchange rate changes 14 ( 6 ) 3
−Removed: Ending balance, as of December 31 211 415 112
Prepaid expenses and other current assets consist of the following:
6 unchanged sentences
Prepaid manufacturing cost 42,066 58,950
−Removed: Short-term deposit 1,510 2,982
Other current assets 56,799 36,157
8 unchanged sentences
As of December 31,
−Removed: Goodwill 109 109
Prepayment of property and equipment 4,144 22,025
2 unchanged sentences
Rental deposits and other 8,195 7,054
+Added: Long-term restricted cash 2,711 5,277
Long-term investments 89,644 91,779
15 unchanged sentences
Pension liability 14,995 7,760
+Added: Asset retirement obligation 1,127 —
+Added: Other 184 159
Total other long-term liabilities 50,510 46,095
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
The following table summarizes the Company’s short-term and long-term debt obligations as of December 31, 2023 and 2022:
6 unchanged sentences
November 8, 2029 (3) 5,636 40,000 5,437 37,500
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: China Minsheng Bank (the "Senior Loan") September 24, 2020 $ 200,000 (4) 4.3 % 150,000 1,034,554 200,000 1,274,535
−Removed: Zhuhai Hillhouse (the "Related Party Loan") September 24, 2020 RMB 500,000 (5) 4.5 % — — 15,693 100,000
+Added: China Merchants Bank July 28, 2023 $ 380,000 1 -year
+Added: December 25, 2024 (4) 300,000 2,129,321 — —
+Added: China Minsheng Bank December 20, 2023 $ 150,000 1 -year
+Added: December 19, 2024 7.3 % 150,000 1,064,660 — —
+Added: China Minsheng Bank September 24, 2020 $ 200,000 (5) — — 150,000 1,034,554
Shanghai Pudong Development Bank February 25, 2022 $ 50,000 1 -year
February 25, 2023 2.2 % — — 50,000 344,851
+Added: China Merchants Bank June 5, 2023 RMB 400,000 1 -year
+Added: June 4, 2024 3.2 % 56,356 400,000 — —
+Added: HSBC Bank May 4, 2023 RMB 340,000 1 -year
+Added: May 3, 2024 (6) 47,903 340,000 — —
+Added: China Industrial Bank May 30, 2023 RMB 200,000 1 -year
+Added: May 29, 2024 2.8 % 28,177 200,000 — —
+Added: Shanghai Pudong Development Bank November 14, 2023 RMB 700,000 1 -year
+Added: November 21, 2024 2.9 % 49,312 350,000 — —
Other short-term debt (7) 28,037 199,000 114,832 792,000
14 unchanged sentences
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.
−Removed: The loan is secured by Guangzhou Factory's second land use right and fixed assets that will be placed into service upon completion of the second phase of the Guangzhou manufacturing facility's build out.
+Added: The loan is secured by Guangzhou Factory’s second land use right and certain fixed assets in 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, 2021, the borrowing capacity was reduced from RMB 1,100,000 to RMB 350,000 .
2 unchanged sentences
BeiGene Guangzhou Biologics Manufacturing Co., Ltd.
−Removed: is a company incorporated under the laws of the PRC on March 3, 2017 and a wholly owned subsidiary of BeiGene Biologics.
+Added: is a company incorporated under the laws of the PRC on March 3, 2017 and a wholly owned subsidiary of BeiGene Biologics Co., Ltd.
+Added: (“BeiGene Biologics”).
The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC.
1 unchanged sentence
The loan is secured by fixed assets that will be placed into service upon completion of the third phase of the Guangzhou manufacturing facility’s build out.
−Removed: 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.
−Removed: 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.
−Removed: The Company may extend the original maturity date for up to two additional twelve month periods.
−Removed: 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.
−Removed: On September 30, 2022, the Company entered into an amendment and restatement agreement with China Minsheng Bank to extend the maturity date.
−Removed: On October 10, 2022, the Company repaid $ 200,000 and drew down $ 150,000 from the Senior Loan.
−Removed: 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.
−Removed: The loan originally matured at the earlier of:
−Removed: (i) November 9, 2021, which is one month after the Senior Loan maturity date, if not extended, or (ii) 10 business days after the Senior Loan is fully repaid.
−Removed: On October 8, 2021, the Company extended the maturity date of the Related Party Loan to the earlier of:
−Removed: (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.
−Removed: On October 10, 2022, the Company repaid in full the outstanding borrowing in the amount of $ 13,980 (RMB 100,000 ).
−Removed: Zhuhai Hillhouse is a related party of the Company, as it is an affiliate of Hillhouse Capital.
−Removed: Hillhouse Capital is a shareholder of the Company, and a Hillhouse Capital employee is a member of the Company's board of directors.
−Removed: During the 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.
−Removed: The Company drew down $ 113,774 (RMB 792,000 ) during the year ended December 31, 2022.
−Removed: The Company repaid $ 200,446 (RMB 1,332,197 ) of the short-term loans during the year ended.
−Removed: December 31, 2022.
−Removed: The weighted average interest rate for the short-term working capital loans was approximately 2.6 % as of December 31, 2022.
−Removed: 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.
+Added: The Company repaid $ 5,281 (RMB 37,500 ) during the year ended December 31, 2023.
+Added: The outstanding borrowings bear floating interest rates benchmarking the Secured Overnight Financing Rate (“SOFR”).
The loan interest rate was 7.2 % as of December 31, 2023.
−Removed: The loan is secured by BeiGene Suzhou Co., Ltd.'s land use right.
−Removed: The Company drew down $ 37,372 (RMB 252,000 ) during the year ended December 31, 2022.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: In September 2020, the Company entered into a loan agreement with China Minsheng Bank for a total loan facility of up to $ 200,000 , of which $ 120,000 designated to fund the purchase of noncontrolling equity interest in BeiGene Biologics from Guangzhou GET Technology Development Co., Ltd.
+Added: (now Guangzhou High-tech Zone Technology Holding Group Co., Ltd.) (“GET”) and repayment of the Shareholder Loan and $ 80,000 was designated for general working capital purposes.
+Added: The loan had an original maturity date of October 8, 2021, which was the first anniversary of the first date of utilization of the loan.
+Added: The Company may extend the original maturity date for up to two additional twelve -month periods.
+Added: On October 8, 2021, the Company extended the maturity date for twelve months to October 8, 2022 and repurposed the loan for general working capital purposes.
+Added: On September 30, 2022, the Company entered into an amendment and restatement agreement with China Minsheng Bank to extend the maturity date.
+Added: The Company repaid the outstanding principal of the loan in the amount of $ 150,000 during the year ended December 31, 2023.
+Added: The outstanding borrowings bear floating interest rates benchmarking Hong Kong interbank market rate for RMB.
+Added: The loan interest rate was 4.5 % as of December 31, 2023.
+Added: During the two years ended December 31, 2023, the Company entered into additional short-term working capital loans with China Industrial Bank and China Merchants Bank to borrow up to RMB 875,000 in aggregate, with maturity dates ranging from December 15, 2022 to May 24, 2024.
+Added: The Company drew down $ 28,174 (RMB 199,000 ) and repaid $ 109,576 (RMB 792,000 ) during the year ended December 31, 2023.
+Added: The weighted average interest rate for the short-term working capital loans was approximately 3.2 % as of December 31, 2023.
+Added: The outstanding principal balance is due in May 2024.
+Added: In July 2022, the Company entered into a 10 -year bank loan agreement with China CITIC Bank to borrow up to RMB 480,000 at a floating interest rate benchmarked against prevailing interest rates of certain PRC financial institutions.
+Added: The loan interest rate was 3.9 % as of December 31, 2023 .
+Added: The loan is secured by BeiGene Suzhou Co., Ltd.’s land use right and certain fixed assets that will be placed into service upon completion of the small molecule manufacturing campus in Suzhou, China.
+Added: The Company drew down $ 22,502 (RMB 163,000 ) during the year ended December 31, 2023.
+Added: The Company has numerous financial and non-financial covenants on its debt obligations with various banks and other lenders.
+Added: Some of these covenants include cross-default provisions that could require acceleration of repayment of loans in the event of default.
+Added: However, the Company’s debt is primarily short-term in nature.
+Added: Any acceleration would be a matter of months but may impact the Company’s ability to refinance debt obligations if an event of default occurs.
+Added: As of December 31, 2023, the Company is in compliance with all covenants of our material debt agreements.
Contractual Maturities of Debt Obligations
9 unchanged sentences
Interest Expense
−Removed: Interest on bank loans and the Related Party Loan is paid quarterly until the respective loans are fully settled.
+Added: Interest on bank loans is paid quarterly until the respective loans are fully settled.
Interest expense recognized for the years ended December 31, 2023, 2022 and 2021 amounted to $ 20,800 , $ 21,699 and $ 29,263 , respectively, among which, $ 16,571 , $ 2,594 and $ 1,054 was capitalized, respectively.
Product Revenue
−Removed: 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;
−Removed: REVLIMID ® and VIDAZA ® in China under a license from BMS;
+Added: The Company’s product revenue is primarily derived from the sale of its internally developed products BRUKINSA in the U.S., China, and other regions, and tislelizumab and pamiparib in China;
XGEVA, BLINCYTO and KYPROLIS in China under a license from Amgen;
+Added: REVLIMID ® and VIDAZA ® in China under a license from BMS;
and POBEVCY ® in China under a license from Bio-Thera.
−Removed: The table below presents the Company’s net product sales for the years ended December 31, 2022, 2021 and 2020.
−Removed: Year Ended December 31,
−Removed: 2022 2021 2020
−Removed: Product revenue - gross 1,438,440 748,824 324,672
−Removed: Rebates and sales returns ( 183,828 ) ( 114,837 ) ( 15,798 )
−Removed: Product revenue - net 1,254,612 633,987 308,874
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: The table below presents the Company’s net product sales for the years ended December 31, 2023, 2022 and 2021.
+Added: Year Ended December 31,
+Added: 2023 2022 2021
+Added: Product revenue - gross 2,718,969 1,438,440 748,824
+Added: Rebates and sales returns ( 529,117 ) ( 183,828 ) ( 114,837 )
+Added: Product revenue - net 2,189,852 1,254,612 633,987
The following table disaggregates net product revenue by product for the years ended December 31, 2023, 2022 and 2021.
8 unchanged sentences
39,799 13,696 —
+Added: 13,960 15,213 19,591
Pamiparib 6,668 5,460 3,661
1 unchanged sentence
Total product revenue - net 2,189,852 1,254,612 633,987
−Removed: The following table presents the roll-forward of accrued sales rebates and returns for the years ended December 31, 2022 and December 31, 2021.
+Added: The following table presents the roll-forward of accrued sales rebates and returns for the years ended December 31, 2023 and 2022.
Year Ended December 31,
3 unchanged sentences
Ending balance, as of December 31 139,936 41,817
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
Loss Per Share
3 unchanged sentences
Net loss ( 881,708 ) ( 2,003,815 ) ( 1,457,816 )
−Removed: Net loss attributable to noncontrolling interest — — ( 3,617 )
−Removed: Net loss attributable to BeiGene, Ltd.
−Removed: ( 2,003,815 ) ( 1,457,816 ) ( 1,624,974 )
Weighted average shares outstanding for computing basic and diluted loss per share 1,357,034,547 1,340,729,572 1,206,210,049
−Removed: Net loss per share attributable to BeiGene, Ltd., basic and diluted ( 1.49 ) ( 1.21 ) ( 1.50 )
+Added: Loss per share ( 0.65 ) ( 1.49 ) ( 1.21 )
For the years ended December 31, 2023, 2022 and 2021, the computation of basic loss per share using the two-class method was not applicable, as the Company was in a net loss position.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: 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, 2023, 2022 and 2021.
15 unchanged sentences
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.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
2018 Inducement Equity Plan
8 unchanged sentences
Initially, 3,500,000 ordinary shares of the Company were reserved for issuance under the ESPP.
−Removed: In August 2018, in connection with the Hong Kong IPO, the board of directors of the Company approved an amended and restated ESPP to remove an “evergreen” share replenishment provision originally included in the plan and implement other changes required by
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
−Removed: the HKEx rules.
+Added: In August 2018, in connection with the Hong Kong IPO, the board of directors of the Company approved an amended and restated ESPP to remove an “evergreen” share replenishment provision originally included in the plan and implement other changes required by 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.
11 unchanged sentences
February 26, 2021 436,124 $ 236.30 $ 18.18 $ 200.86 $ 15.45 $ 6,738
−Removed: 1 The market price is the lower of the closing price on the NASDAQ Stock Market on the issuance date or the offering date, in accordance with the terms of the ESPP.
+Added: 1 The market price is the lower of the closing price on NASDAQ 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.
60 unchanged sentences
Restricted shares
−Removed: The following table summarizes the Company’s restricted share activities under the 2016 Plan:
−Removed: of Shares Weighted-Average
−Removed: Grant Date Fair Value
−Removed: Outstanding at December 31, 2019 75,000 2.27
−Removed: Vested ( 75,000 ) 2.27
−Removed: Forfeited — —
−Removed: Outstanding at December 31, 2020 — —
−Removed: The Company had no restricted share activities during the year ended December 31, 2022 and 2021.
+Added: The Company had no restricted share activities during the years ended December 31, 2023, 2022 and 2021.
As of December 31, 2023, all compensation cost related to restricted shares was fully recognized.
48 unchanged sentences
December 31, 2023 ( 87,987 ) 35 ( 11,494 ) ( 99,446 )
−Removed: (1) The amounts reclassified from accumulated other comprehensive (loss) income were included in other (expense) income, net in the consolidated statements of operations.
+Added: (1) The amounts reclassified from accumulated other comprehensive (loss) income were included in other income (expense), net in the consolidated statements of operations.
Shareholders’ Equity
During the years ended December 31, 2023, 2022 and 2021, the Company completed the following equity offerings:
−Removed: In January 2020, the Company sold 15,895,001 ADSs, representing a 20.5 % ownership stake in the Company, to Amgen for aggregate cash proceeds of $ 2,779,241 , or $ 174.85 per ADS, pursuant to the Share Purchase Agreement executed in connection with the Amgen Collaboration Agreement.
−Removed: On March 17, 2020, BeiGene, Ltd.
−Removed: and Amgen entered into an Amendment No.
−Removed: 2 (the “Second Amendment”) to the Share Purchase Agreement in order to account for periodic dilution from the issuance of shares by the Company, which was restated in its entirety on September 24, 2020 (the “Restated Second Amendment”).
−Removed: 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.
−Removed: 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 %.
−Removed: 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.
−Removed: The exercise period of the Direct Purchase Option commenced on December 1, 2020 and will terminate on the earliest of:
−Removed: (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;
−Removed: (b) at least 60-day advance written notice from either Amgen or the Company that such party wishes to terminate the Direct Purchase Option;
−Removed: or (c) December 1, 2023.
−Removed: The Direct Purchase Option has no vesting period.
−Removed: 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.
−Removed: Advisors LP, as well as Amgen, in a registered direct offering under the Company's effective Registration Statement on Form S-3 (File No.
−Removed: 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 .
−Removed: Amgen purchased 29,614,832 ordinary shares for $ 421,443 as part of this offering.
−Removed: 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.
−Removed: BEIGENE, LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
−Removed: (Amounts in thousands of U.S.
−Removed: Dollar (“$”) and Renminbi (“RMB”),
−Removed: except for number of shares and per share data)
In September 2021, upon Amgen’s exercise of its Direct Purchase Option, the Company issued an aggregate of 165,529 ADSs, representing 2,151,877 ordinary shares, to Amgen Inc.
6 unchanged sentences
As required by the PRC securities laws, the net proceeds from the STAR Offering must be used in strict compliance with the planned uses as disclosed in the PRC prospectus as well as the Company’s proceeds management policy for the STAR Offering approved by the board of directors.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
+Added: BMS Settlement
+Added: On August 1, 2023, the Company entered into a Settlement and Termination Agreement (the “Settlement Agreement”) with BMS-Celgene and certain of its affiliates relating to the termination of the parties’ ongoing contractual relationships, the previously-disclosed ongoing arbitration proceeding concerning ABRAXANE ® (the “Arbitration”), the License and Supply Agreement (“LSA”), the Amended and Restated Quality Agreement (the “QA”), and the Share Subscription Agreement (the “SSA”), entered into by the parties in 2017 and 2018.
+Added: Pursuant to the Settlement Agreement, the parties agreed to mutually dismiss the Arbitration and BMS-Celgene and its affiliates agreed to transfer 23,273,108 ordinary shares of the Company originally purchased in 2017, in each case subject to and in accordance with the terms and conditions of the Settlement Agreement.
+Added: In consideration for the shares being returned, the Company agreed to drop its claims pursuant to the Settlement Agreement.
+Added: Furthermore, the parties agreed to terminate the LSA and QA on December 31, 2023, subject to the Company’s right to continue selling all inventory of REVLIMID and VIDAZA until sold out or December 31, 2024, whichever is earlier.
+Added: The Settlement Agreement provides for a settlement and release by each party of claims arising from or relating to the Arbitration, the LSA, the QA and the SSA, as well as other disputes and potential disputes between the parties, in each case subject to and in accordance with the terms and conditions of the Agreement.
+Added: The receipt of the shares occurred on August 15, 2023.
+Added: The Company recorded a noncash gain upon receipt of $ 362,917 , which represents the fair value on the day the shares were received.
+Added: The gain was recorded within other income (expense), net in the consolidated statements of operations.
+Added: The shares were constructively retired as of December 31, 2023.
+Added: The Company recorded the amount of the cancelled shares in excess of par to additional paid-in capital.
Restricted Net Assets
16 unchanged sentences
The total amounts for such employee benefits, which were expensed as incurred, were $ 94,358 , $ 83,860 and $ 63,772 for the years ended December 31, 2023, 2022 and 2021, respectively.
−Removed: The Company maintains a defined contribution 401(k) savings plan (the "401(k) Plan") for U.S.
−Removed: The 401(k) Plan covers all U.S.
−Removed: employees, and allows participants to defer a portion of their annual compensation on a pretax basis.
−Removed: 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 %.
−Removed: 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.
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
+Added: The Company maintains a defined contribution 401(k) savings plan (the “401(k) Plan”) for U.S.
+Added: The 401(k) Plan covers all U.S.
+Added: employees, and allows participants to defer a portion of their annual compensation on a pretax basis.
+Added: In addition, the Company has a matching contribution to the 401(k) Plan, which, in the 2023 plan year, matched dollar for dollar of eligible contributions up to 4 %.
+Added: Company contributions to the 401(k) Plan totaled $ 15,316 , $ 10,298 and $ 7,483 in the years ended December 31, 2023, 2022 and 2021, respectively.
The Company maintains a government mandated program to cover its employees in Switzerland for pension, death, or disability.
2 unchanged sentences
Company contributions into the program amounted to $ 2,710 , $ 3,887 , and $ 2,986 in the years ended December 31, 2023, 2022 and 2021, respectively.
−Removed: Employee benefit expenses for the remaining subsidiaries were immaterial.
+Added: Company contributions into defined contribution plans for the remaining subsidiaries were immaterial.
Defined Benefit Plan
7 unchanged sentences
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, 2023:
+Added: Year ending December 31, 2024 607
+Added: Year ending December 31, 2025 214
+Added: Year ending December 31, 2026 580
+Added: Year ending December 31, 2027 985
+Added: Year ending December 31, 2028 811
+Added: Thereafter 9,569
Commitments and Contingencies
2 unchanged sentences
The Company does not have any minimum purchase requirements for inventory from BMS or Amgen.
−Removed: Capital commitments
−Removed: 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.
−Removed: Co-development funding commitment
−Removed: 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 .
−Removed: The Company is funding its portion of the co-
BEIGENE, LTD.
4 unchanged sentences
except for number of shares and per share data)
−Removed: development costs by contributing cash and/or development services.
+Added: Capital Commitments
+Added: The Company had capital commitments amounting to $ 333,498 for the acquisition of property, plant and equipment as of December 31, 2023, which were mainly for the Company’s manufacturing and clinical R&D campus in Hopewell, New Jersey, additional capacity at the Guangzhou and Suzhou manufacturing facilities, and a new building for Beijing Innerway Bio-tech Co., Ltd.
+Added: Co-Development Funding Commitment
+Added: Under the Amgen Collaboration Agreement, the Company is responsible for co-funding global clinical development costs for the Amgen oncology pipeline assets up to a total cap of $ 1,250,000 .
+Added: The Company is funding its portion of the co-development costs by contributing cash and/or development services.
As of December 31, 2023, the Company's remaining co-development funding commitment was $ 483,651 .
−Removed: Research and Development Commitment
−Removed: The Company entered into long-term research and development agreements, which include obligations to make upfront payments and fixed quarterly payments over the next four years .
−Removed: As of December 31, 2022, the total research and development commitment amounted to $ 22,327 .
Funding Commitment
14 unchanged sentences
The Company’s long-lived assets are primarily located in the PRC and the U.S.
+Added: BEIGENE, LTD.
+Added: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
+Added: (Amounts in thousands of U.S.
+Added: Dollar (“$”) and Renminbi (“RMB”),
+Added: except for number of shares and per share data)
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.
2 unchanged sentences
2023 2022 2021
−Removed: PRC 840,032 517,173 290,646
−Removed: 502,626 495,265 18,228
−Removed: ROW 73,263 163,845 —
−Removed: Total 1,415,921 1,176,283 308,874
−Removed: PRC revenues for each of the three years in the period ended December 31, 2022 consisted entirely of product sales.
−Removed: revenues for the year ended December 31, 2022 consisted of collaboration revenues of $ 112,916 and BRUKINSA product sales of $ 389,710 , respectively.
−Removed: revenues for the year ended December 31, 2021 consisted of collaboration revenue of $ 379,607 and BRUKINSA product sales of $ 115,658 , respectively.
−Removed: revenues for the year ended December 31, 2020 consisted entirely of BRUKINSA product sales.
−Removed: 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.
−Removed: Rest of world revenues for each of the year ended December 31, 2021 consisted primarily of collaboration revenues.
−Removed: Supplementary Information
−Removed: 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.
−Removed: The operating results for any fiscal quarter are not necessarily indicative of the operating results for a full fiscal year or for any future period and there can be no assurances that any trend reflected in such results will continue in the future.
−Removed: 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.
−Removed: The following table summarizes the unaudited statements of operations for each quarter of 2022 and 2021 (in thousands except share and per share amounts).
−Removed: Quarter Ended
−Removed: March 31, June 30, September 30, December 31,
−Removed: Total revenues 306,626 341,572 387,628 380,095
−Removed: Loss from operations (443,287) (439,399) (438,357) (468,622)
−Removed: Net loss (435,198) (565,726) (557,556) (445,335)
−Removed: Net loss attributable to BeiGene, Ltd.
−Removed: (435,198) (565,726) (557,556) (445,335)
−Removed: Net loss per share attributable to BeiGene, Ltd., basic and diluted (0.33) (0.42) (0.41) (0.33)
−Removed: Quarter Ended
−Removed: March 31, June 30, September 30, December 31,
−Removed: Total revenues 605,872 149,992 206,440 213,979
−Removed: Income (loss) from operations 70,167 (474,838) (462,325) (571,739)
−Removed: Net income (loss) 55,580 (484,604) (438,114) (590,678)
−Removed: Net income (loss) attributable to BeiGene, Ltd.
−Removed: 55,580 (484,604) (438,114) (590,678)
−Removed: Net income (loss) per share attributable to BeiGene, Ltd., basic 0.05 (0.41) (0.36) (0.48)
−Removed: Net income (loss) per share attributable to BeiGene, Ltd., diluted 0.04 (0.41) (0.36) (0.48)
+Added: - total revenue 1,128,219 502,626 495,265
+Added: Product revenue 945,551 389,710 115,658
+Added: Collaboration revenue 182,668 112,916 379,607
+Added: China- total revenue 1,101,951 840,032 517,104
+Added: Product revenue 1,093,091 840,032 517,104
+Added: Collaboration revenue 8,860 — —
+Added: Europe- total revenue 202,014 63,257 163,051
+Added: Product revenue 122,228 14,864 362
+Added: Collaboration revenue 79,786 48,393 162,689
+Added: Rest of world- total revenue 26,595 10,006 863
+Added: Product revenue 28,982 10,006 863
+Added: Collaboration revenue ( 2,387 ) — —
+Added: Total Revenue 2,458,779 1,415,921 1,176,283
Exhibit Index
2 unchanged sentences
Herein from Form or Schedule Filing Date SEC File/
−Removed: 3.1 Sixth Amended and Restated Memorandum and Articles of Association of the Registrant, as currently in effect
+Added: 3.1 Seventh Amended and Restated Memorandum and Articles of Association of the Registrant, as currently in effect
(Exhibit 3.1) 6/15/2023 001-37686
22 unchanged sentences
(Exhibit 10.1) 12/2/2020 001-37686
−Removed: 4.6 Description of the Registrant 's Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934
−Removed: Collaboration, License and Commercial Agreements
−Removed: 10.1# .1# License and Supply Agreement, dated July 5, 2017, by and between the Registrant and Celgene Logistics Sàrl
+Added: .3 Amendment No.
+Added: 2 to Registration Rights Agreement, dated May 3, 2023, between the Company and the Investors
(Exhibit 10.3) 5/4/2023 001-37686
+Added: 4.6 Description of the Registrant ’ s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934
Exhibit Description Filed/ Furnished
1 unchanged sentence
Herein from Form or Schedule Filing Date SEC File/
−Removed: .2 Assignment and Assumption Agreement, dated December 29, 2017, by and between the Registrant and BeiGene Switzerland GmbH
−Removed: (Exhibit 10.6.1)
−Removed: 3/2/2020 001-37686
+Added: Collaboration, License and Commercial Agreements
10.1 Share Subscription Agreement, dated July 5, 2017, by and between Celgene Switzerland LLC and the Registrant
12 unchanged sentences
3 to Share Purchase Agreement, dated January 30, 2023, by and between the Registrant and Amgen Inc.
+Added: (Exhibit 10.4.4) 2/27/2023 001-37686
Exhibit Description Filed/ Furnished
5 unchanged sentences
(Exhibit 10.1) 8/8/2022 001-37686
+Added: .3## Second Amendment to Collaboration Agreement, dated February 26, 2023, by and among the Registrant, BeiGene Switzerland GmbH and Amgen Inc.
+Added: (Exhibit 10.1) 5/4/2023 001-37686
10.5 Guarantee, dated October 31, 2019, by and between the Registrant and Amgen Inc.
(Exhibit 10.12) 3/2/2020 001-37686
−Removed: 10.7## .1## Collaboration and License Agreement, dated January 11, 2021, by and between BeiGene Switzerland GmbH and Novartis Pharma AG
+Added: 10.6 .1 Mutual Termination and Release Agreement, dated July 10, 2023, by and between BeiGene Switzerland GmbH and Novartis Pharma AG
(Exhibit 10.1) 8/2/2023 001-37686
−Removed: .2## Option, Collaboration and License Agreement, dated December 19, 2021, by and between BeiGene Switzerland GmbH and Novartis Pharma AG
+Added: .2## Mutual Termination and Release Agreement, dated September 17, 2023, by and between BeiGene Switzerland GmbH and Novartis Pharma AG
(Exhibit 10.2) 11/9/2023 001-37686
22 unchanged sentences
(Exhibit 10.10) 8/2/2023 001-37686
−Removed: 10.10† .1† Third Amended and Restated 2018 Employee Share Purchase Plan
−Removed: (Exhibit 10.7) 8/5/2021 001-37686
Exhibit Description Filed/ Furnished
1 unchanged sentence
Herein from Form or Schedule Filing Date SEC File/
+Added: 10.9† Third Amended and Restated 2018 Employee Share Purchase Plan
+Added: (Exhibit 10.7) 8/5/2021 001-37686
10.10† Senior Executive Cash Incentive Bonus Plan
10 unchanged sentences
(Exhibit 10.1) 8/9/2018 001-37686
−Removed: .2† Employment Apportionment Agreement, dated March 1, 2020, by and between BeiGene (Beijing) Co., Ltd., BeiGene Guangzhou Biologics Manufacturing Co., Ltd.
+Added: .2† Amended and Restated Employment Apportionment Agreement, dated June 16, 2023, by and between BeiGene (Beijing) Co., Limited , BeiGene Guangzhou Biologics Manufacturing Co., Ltd., BeiGene Pharmaceutical (Shanghai) Co., Ltd.
and Xiaobin Wu
2 unchanged sentences
(Exhibit 10.9) 8/5/2021 001-37686
−Removed: 10.18† Consulting Agreement, dated February 24, 2021, by and between the Registrant and Xiaodong Wang
−Removed: (Exhibit 10.20) 2/25/2021 001-37686
+Added: 10.16† Consulting Agreement, dated December 7, 2023, by and between the Registrant and Xiaodong Wang
10.17† Employment Agreement, dated December 30, 2021, by and between BeiGene (Shanghai) Co., Ltd.
(Exhibit 10.20) 2/28/2022 001-37686
−Removed: 16.1 Letter from Ernst & Young Hua Ming LLP addressed to the U.S.
−Removed: Securities and Exchange Commission dated March 25, 2022
+Added: 10.18† Offer Letter, dated June 10, 2022, by and between the Registrant and Chan Lee
(Exhibit 10.3) 8/2/2023 001-37686
−Removed: 21.1 List of Subsidiaries of the Registrant
Exhibit Description Filed/ Furnished
1 unchanged sentence
Herein from Form or Schedule Filing Date SEC File/
+Added: Other Agreements
+Added: 10.19 Facility Agreement, dated as of July 28, 2023, by and between the Registrant and China Merchants Bank Co., Ltd.
+Added: (Exhibit 10.2) 8/2/2023 001-37686
+Added: 10.20## Settlement and Termination Agreement, dated as of August 1, 2023, by and between the Registrant, BeiGene Switzerland GmbH, Bristol-Myers Squibb Company, Celgene Corporation, Celgene Switzerland LLC, Celgene Kappa Holdings LLC, Celgene Holdings East Corporation and Celgene Logistics Sàrl
+Added: (Exhibit 10.1) 11/9/2023 001-37686
+Added: 10.21## First Amendment to the Settlement and Termination Agreement, dated as of January 10, 2024, by and between the Registrant, BeiGene Switzerland GmbH, Bristol-Myers Squibb Company, Celgene Corporation, Celgene Switzerland LLC, Celgene Kappa Holdings LLC, Celgene Holdings East Corporation and Celgene Logistics Sàrl
+Added: 19.1 Insider Trading Policy
+Added: 19.2 Special Trading Procedures for Insiders
+Added: 21 List of Subsidiaries of the Registrant
23.1 Consent of Ernst & Young LLP
4 unchanged sentences
Section 1350, as adopted pursuant to Section 906 of the Sarbanes‑Oxley Act of 2002
+Added: 97 Compensation Recovery Policy
99.1 Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
4 unchanged sentences
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document X
+Added: Exhibit Description Filed/ Furnished
+Added: Herewith Incorporated by Reference
+Added: Herein from Form or Schedule Filing Date SEC File/
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document X
19 unchanged sentences
Julia Wang (Principal Financial and Accounting Officer)
+Added: /s/ OLIVIER BRANDICOURT Director February 26, 2024
+Added: Olivier Brandicourt
/s/ MARGARET DUGAN Director February 26, 2024
8 unchanged sentences
Ranjeev Krishana
−Removed: /s/ THOMAS MALLEY Director February 27, 2023
−Removed: Thomas Malley
/s/ ALESSANDRO RIVA Director February 26, 2024
7 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.