What changed in this filing

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Item 1. Financial Statements

2025-05-07 compared with 2024-11-12 · 209 added, 317 removed, 437 unchanged (55% of the section changed)

4 unchanged sentences

Dollars (“$”), except for number of shares and per share data)

Three Months Ended Nine Months Ended

September 30, September 30,

Three Months Ended

Note 2025 2024

8 unchanged sentences

Total operating expenses 941,175 888,065

Loss from operations ( 120,265 ) ( 133,968 ) ( 488,774 ) ( 823,941 )

Income (loss) from operations 11,102 ( 261,348 )

Interest income, net 5,848 16,160

Other income, net 3,950 1,762

(Loss) income before income taxes ( 98,304 ) 229,338 ( 447,650 ) ( 475,064 )

Income (loss) before income taxes 20,900 ( 243,426 )

Income tax expense 8 19,630 7,724

Net (loss) income ( 121,350 ) 215,413 ( 492,905 ) ( 514,155 )

(Loss) earnings per share

Net income (loss) 1,270 ( 251,150 )

Earnings (loss) per share

Basic 12 0.00 ( 0.19 )

2 unchanged sentences

Weighted-average shares outstanding—diluted 1,445,253,219 1,355,547,626

(Loss) earnings per American Depositary Share (“ADS”)

Earnings (loss) per American Depositary Share (“ADS”)

Basic 12 0.01 ( 2.41 )

7 unchanged sentences

Dollars (“$”))

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

Net (loss) income ( 121,350 ) 215,413 ( 492,905 ) ( 514,155 )

Three Months Ended

Net income (loss) 1,270 ( 251,150 )

Other comprehensive income (loss), net of tax of nil:

Foreign currency translation adjustments 6,441 ( 32,163 )

Pension liability adjustments 202 — 608 —

Unrealized holding income (loss), net — 1,315 ( 35 ) 8,218

Comprehensive (loss) income ( 64,401 ) 214,169 ( 476,984 ) ( 581,669 )

Other adjustments 226 ( 35 )

Comprehensive income (loss) 7,937 ( 283,348 )

The accompanying notes are an integral part of these condensed consolidated financial statements.

3 unchanged sentences

Dollars (“$”), except for number of shares and per share data)

September 30, December 31,

March 31, December 31,

Note 2025 2024

22 unchanged sentences

Non-current liabilities:

Long-term bank loans 10 187,513 197,618

Long-term debt 10 160,157 166,484

Operating lease liabilities, non-current portion 54,895 44,277

8 unchanged sentences

9,500,000,000 shares authorized;

1,386,034,320 and 1,359,513,224 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

1,403,281,823 and 1,387,367,704 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively

Additional paid-in capital 12,247,260 12,087,908

8 unchanged sentences

Dollars (“$”))

Nine Months Ended September 30,

Three Months Ended March 31,

Note 2025 2024

Operating activities:

Net loss ( 492,905 ) ( 514,155 )

Adjustments to reconcile net loss to net cash used in operating activities:

Net income (loss) 1,270 ( 251,150 )

Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

Depreciation and amortization expense 32,804 25,293

Share-based compensation expenses 13 95,478 88,667

Acquired in-process research and development — 15,000

Amortization of research and development cost share liability 3 ( 19,812 ) ( 13,136 )

Gain on BMS termination settlement 15 — ( 362,917 )

Other items, net 12,369 ( 2,887 )

5 unchanged sentences

Accrued expenses and other payables ( 52,360 ) ( 79,309 )

Deferred revenue 477 ( 255,587 )

Other liabilities 4,043 ( 660 )

Net cash used in operating activities ( 215,791 ) ( 935,815 )

Net cash provided by (used in) operating activities 44,082 ( 308,572 )

Investing activities:

4 unchanged sentences

Other investing activities ( 7,334 ) ( 19,434 )

Net cash (used in) provided by investing activities ( 454,745 ) 122,588

Net cash used in investing activities ( 121,941 ) ( 209,831 )

Financing activities:

4 unchanged sentences

Proceeds from option exercises and employee share purchase plan 63,359 14,791

Other financing activities 3,000 —

Net cash provided by financing activities 197,972 69,430

Net cash (used in) provided by financing activities ( 33,777 ) 162,293

Effect of foreign exchange rate changes, net 3,480 ( 22,438 )

10 unchanged sentences

Capital expenditures included in accounts payable and accrued expenses 60,010 100,473

ROU assets obtained in exchange for new operating lease liabilities 15,659 839

Increase in equity investment from deconsolidation of a subsidiary — 40,798

Acquired intangible asset included in accounts payable — 9,384

The accompanying notes are an integral part of these condensed consolidated financial statements.

9 unchanged sentences

Balance at December 31, 2024 1,387,367,704 138 12,087,908 ( 148,988 ) ( 8,606,836 ) 3,332,222

Use of shares reserved for share option exercises ( 3,634,952 ) — — — — —

Exercise of options, ESPP and release of RSUs 3,646,097 1 15,662 — — 15,663

Share-based compensation — — 88,667 — — 88,667

Deconsolidation of a subsidiary — — 2,052 — — 2,052

Other comprehensive loss — — — ( 32,198 ) — ( 32,198 )

Net loss — — — — ( 251,150 ) ( 251,150 )

Balance at March 31, 2024 1,359,524,369 136 11,705,069 ( 131,644 ) ( 8,213,200 ) 3,360,361

Issuance of shares reserved for share option exercises 402,532 — — — — —

1 unchanged sentence

Share-based compensation — — 95,478 — — 95,478

Other comprehensive loss — — — ( 8,830 ) — ( 8,830 )

Net loss — — — — ( 120,405 ) ( 120,405 )

Balance at June 30, 2024 1,379,101,901 137 11,840,197 ( 140,474 ) ( 8,333,605 ) 3,366,255

Issuance of shares reserved for share option exercises 1,944,995 — — — — —

Exercise of options, ESPP and release of RSUs 4,987,424 1 19,521 — — 19,522

Share-based compensation — — 114,697 — — 114,697

Other comprehensive income — — — 6,667 — 6,667

Net loss — — — — ( 121,350 ) ( 121,350 )

Balance at September 30, 2024 1,386,034,320 138 11,974,415 ( 83,525 ) ( 8,454,955 ) 3,436,073

Net income — — — — 1,270 1,270

Balance at March 31, 2025 1,403,281,823 140 12,247,260 ( 142,321 ) ( 8,605,566 ) 3,499,513

Balance at December 31, 2023 1,359,513,224 135 11,598,688 ( 99,446 ) ( 7,962,050 ) 3,537,327

2 unchanged sentences

Share-based compensation — — 88,667 — — 88,667

Other comprehensive income — — — 18,403 — 18,403

Net loss — — — — ( 348,431 ) ( 348,431 )

Balance at March 31, 2023 1,362,652,101 136 11,644,957 ( 59,014 ) ( 7,428,773 ) 4,157,306

Issuance of shares reserved for share option exercises 220,116 — — — — —

Exercise of options, ESPP and release of RSUs 13,379,119 1 3,691 — — 3,692

Share-based compensation — — 103,371 — — 103,371

Deconsolidation of a subsidiary — — 2,052 — — 2,052

Other comprehensive loss — — — ( 32,198 ) — ( 32,198 )

Net loss — — — — ( 251,150 ) ( 251,150 )

Balance at June 30, 2023 1,376,251,336 137 11,752,019 ( 143,687 ) ( 7,809,910 ) 3,798,559

Use of shares reserved for share option exercises ( 4,689,438 ) — — — — —

Exercise of options, ESPP and release of RSUs 4,708,834 — 17,419 — — 17,419

Cancellation of ordinary shares ( 23,273,108 ) ( 2 ) ( 362,915 ) — — ( 362,917 )

Share-based compensation — — 96,004 — — 96,004

Other comprehensive loss — — — ( 1,244 ) — ( 1,244 )

Net income — — — — 215,413 215,413

Balance at September 30, 2023 1,352,997,624 135 11,502,527 ( 144,931 ) ( 7,594,497 ) 3,763,234

Balance at March 31, 2024 1,359,524,369 136 11,705,069 ( 131,644 ) ( 8,213,200 ) 3,360,361

The accompanying notes are an integral part of these condensed consolidated financial statements.

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BeiGene, Ltd.

(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.

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;

TEVIMBRA ® (tislelizumab), an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers;

and PARTRUVIX ® (pamiparib), a selective small molecule inhibitor of PARP1 and PARP2.

The Company markets 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;

TEVIMBRA (tislelizumab) in the U.S., EU and China;

and PARTRUVIX in China.

By leveraging its strong commercial capabilities, the Company has in-licensed the rights to distribute additional approved medicines for the China market.

Supported by its global clinical development and commercial capabilities, the Company has entered into collaborations with world-leading biopharmaceutical companies such as Amgen Inc.

(“Amgen”) and Beijing Novartis Pharma Co., Ltd.

(“Novartis”) to develop and commercialize innovative medicines.

(the “Company”, “BeiGene”, “it”, “its”) is a leading global oncology company discovering and developing innovative treatments that are more accessible and affordable to cancer patients worldwide.

Since its inception in 2010, the Company has become a fully integrated global organization with more than 11,000 employees worldwide.

Basis of presentation and consolidation

The accompanying condensed consolidated balance sheet as of September 30, 2024, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023, the condensed consolidated statements of cash flows for the nine months ended September 30, 2024 and 2023, and the condensed consolidated statements of shareholders’ equity for the three and nine months ended September 30, 2024 and 2023, and the related footnote disclosures are unaudited.

The accompanying condensed consolidated balance sheet as of March 31, 2025, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025 and 2024, the condensed consolidated statements of cash flows for the three months ended March 31, 2025 and 2024, and the condensed consolidated statements of shareholders’ equity for the three months ended March 31, 2025 and 2024, and the related footnote disclosures are unaudited.

The accompanying unaudited interim condensed financial statements were prepared in accordance with U.S.

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The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all normal recurring adjustments, necessary to present a fair statement of the results for the interim periods presented.

Results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results expected for the full fiscal year or for any future annual or interim period.

Results of operations for the three months ended March 31, 2025 are not necessarily indicative of the results expected for the full fiscal year or for any future annual or interim period.

The unaudited interim condensed consolidated financial statements include the financial statements of the Company and its subsidiaries.

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The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period.

Areas where management uses subjective judgment include, but are not limited to, estimating the useful lives of long-lived assets, estimating variable consideration in product sales and collaboration revenue arrangements, identifying separate accounting units and determining the standalone selling price of each performance obligation in the Company’s revenue arrangements, assessing the impairment of long-lived assets, valuation and recognition of share-based compensation expenses, realizability of deferred tax assets, estimating uncertain tax positions, valuation of inventory, estimating the allowance for credit losses, determining defined benefit pension plan obligations, measurement of right-of-use assets and lease liabilities and the fair value of financial instruments.

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, realizability of deferred tax assets, estimating uncertain tax positions, valuation of inventory, estimating the allowance for credit losses, determining defined benefit pension plan obligations, measurement of right-of-use assets and lease liabilities, and the fair value of financial instruments.

Management bases the estimates on historical experience, known trends and various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities and reported amounts of revenues and expenses.

2 unchanged sentences

New accounting standards which have not yet been adopted

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures, which amended ASC 280.

This update requires disclosure of incremental segment information on an annual and interim basis.

This update is effective for annual periods beginning after December 15, 2023, and interim periods within annual periods beginning after December 15, 2024.

In November 2024, the FASB issued Accounting Standards Update (“ASU”) 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40):

Disaggregation of Income Statement Expenses.

This update requires that at each interim and annual reporting period public entities disclose (1) the amounts of purchases of inventory, employee compensation, depreciation, amortization, and depletion) in commonly presented expense captions;

(2) certain amounts that are already required to be disclosed under current GAAP in the same disclosure as the other disaggregation requirements;

(3) a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated quantitatively;

and (4) the total amount of selling expenses and, in annual reporting periods, the definition of selling expenses.

In January 2025, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40):

Clarifying the Effective Date.

This update clarifies that ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027.

Early adoption is permitted.

This guidance should be applied retrospectively to all prior periods presented in the financial statements.

The Company operates in one segment:

pharmaceutical products.

Its chief operating decision maker is the Chief Executive Officer, who makes operating decisions, assesses performance, and allocates resources on a consolidated basis.

Single reportable segment entities are required to comply with all ASC 280 disclosure requirements.

The Company will disclose descriptive information as required under ASC 280 and reference the consolidated financial statements in the segment and geographic information footnote for annual periods beginning January 1, 2024 and interim periods beginning January 1, 2025.

The Company is currently evaluating the impact on its financial statements of adopting this guidance.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):

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Retrospective application is permitted.

The Company is currently evaluating the impact on its financial statements of adopting this guidance.

The Company does not expect that the adoption of ASU 2023-09 will have a significant impact on the Company’s consolidated financial statements as the standard does not change the recognition or measurement of current and deferred income taxes and is currently evaluating the impact on the income tax disclosures.

Significant accounting policies

For a more complete discussion of the Company’s significant accounting policies and other information, the unaudited interim condensed consolidated financial statements and notes thereto should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2024.

There have been no material changes to the Company’s significant accounting policies as of and for the nine months ended September 30, 2024, as compared to the significant accounting policies described in the Annual Report.

There have been no material changes to the Company’s significant accounting policies as of and for the three months ended March 31, 2025, as compared to the significant accounting policies described in the Annual Report.

Fair Value Measurements

8 unchanged sentences

The Company considers an active market to be one in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis, and considers an inactive market to be one in which there are infrequent or few transactions for the asset or liability, the prices are not current, or price quotations vary substantially either over time or among market makers.

The following tables present the Company’s financial assets and liabilities measured and recorded at fair value on a recurring basis using the above input categories as of September 30, 2024 and December 31, 2023:

The following tables present the Company’s financial assets and liabilities measured and recorded at fair value on a recurring basis using the above input categories as of March 31, 2025 and December 31, 2024:

Quoted Price in Active Market for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs

As of September 30, 2024 (Level 1) (Level 2) (Level 3)

As of March 31, 2025 (Level 1) (Level 2) (Level 3)

Cash equivalents

Money market funds 756,296 — —

Prepaid expenses and other current assets:

Convertible debt instrument — — 3,170

Other non-current assets (Note 4):

7 unchanged sentences

Prepaid expenses and other current assets:

Treasury securities 2,600 — —

Convertible debt instrument — — 618

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The Company’s cash equivalents are highly liquid investments with original maturities of 3 months or less.

The Company’s investments in available-for-sale debt securities include U.S.

Treasury securities.

The Company determines the fair value of cash equivalents and available-for-sale debt securities using a market approach based on quoted prices in active markets.

The Company determines the fair value of cash equivalents using a market approach based on quoted prices in active markets.

The Company’s equity securities carried at fair value consist of holdings in common stock and warrants to purchase additional shares of common stock of Leap Therapeutics, Inc.

6 unchanged sentences

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, net.

The Company recorded losses on fair value adjustment of $ 1,802 and $ 1,664 for the three and nine months ended September 30, 2024, respectively.

As of September 30, 2024 and December 31, 2023, the Company held time deposits of $ 15,000 and $ 42,852 that were classified as cash equivalents, respectively.

As of September 30, 2024 and December 31, 2023, the fair values of cash and cash equivalents, restricted cash, accounts receivable, accounts payable, and short-term debt approximated their carrying values due to their short-term nature.

Long-term bank loans approximate their fair value due to the fact that the related interest rates approximate the rates currently offered by financial institutions for similar debt instrument of comparable maturities.

The Company recorded net gains on fair value adjustment of $ 1,136 for the three months ended March 31, 2025.

There were no fair value adjustments for the three months ended March 31, 2024.

As of March 31, 2025 and December 31, 2024, the fair values of cash and cash equivalents, restricted cash, accounts receivable, accounts payable, and short-term debt approximated their carrying values due to their short-term nature.

Long-term debt approximate their fair value due to the fact that the related interest rates approximate the rates currently offered by financial institutions for similar debt instrument of comparable maturities.

Collaborative and Licensing Arrangements

The Company has entered into collaborative arrangements for the research and development, manufacture and/or commercialization of medicines and drug candidates.

The Company enters into collaborative arrangements for the research and development, manufacture and/or commercialization of drug products and drug candidates.

To date, these collaborative arrangements have included out-licenses of and options to out-license internally developed products and drug candidates to other parties, in-licenses of products and drug candidates from other parties, and profit- and cost-sharing arrangements.

These arrangements may include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost-sharing and reimbursement arrangements, royalty payments, and profit sharing.

For detailed descriptions of each arrangement, see the Company’s Form 10-K for the year ended December 31, 2023 filed with the U.S.

For detailed descriptions of each arrangement, see the Company’s Annual Report for the year ended December 31, 2024 filed with the U.S.

Securities and Exchange Commission on February 27, 2025.

Out-Licensing Arrangements

For the three and nine months ended September 30, 2024, the Company’s collaboration revenue consisted primarily of revenue generated under the Novartis broad markets agreement.

For the three and nine months ended September 30, 2023, the Company’s collaboration revenue primarily consisted of the recognition of previously deferred revenue from its former collaboration agreements with Novartis for tislelizumab and ociperlimab.

The following table summarizes total collaboration revenue recognized for the three and nine months ended September 30, 2024 and 2023:

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

For the three months ended March 31, 2025, the Company’s collaboration revenue consisted primarily of royalty revenue under the Amgen collaboration agreement and revenue generated under the Novartis broad markets agreement.

For the three months ended March 31, 2024, collaboration revenue consisted primarily of revenue generated under the Novartis broad markets agreement.

The following table summarizes total collaboration revenue recognized for the three months ended March 31, 2025 and 2024:

Three Months Ended

Revenue from collaborators $ $

Research and development service revenue — 59,052 — 79,432

Right to access intellectual property revenue — 51,978 — 104,475

Material rights revenue — 71,980 — 71,980

Other 8,152 3,008 20,906 9,157

Total 8,152 186,018 20,906 265,044

Tislelizumab Collaboration and License

In September 2023, the Company and Novartis agreed to mutually terminate the tislelizumab collaboration and license agreement.

Pursuant to the termination agreement, the Company regained full, global rights to develop, manufacture and commercialize tislelizumab with no royalty payments due to Novartis.

Novartis may continue its ongoing clinical trials and has the ability to conduct future combination trials with tislelizumab subject to BeiGene’s approval.

BeiGene agreed to provide Novartis with ongoing clinical supply of tislelizumab to support its clinical trials.

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.

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.

Ociperlimab Option, Collaboration and License Agreement and China Broad Market Development Agreement

In July 2023, the Company and Novartis mutually agreed to terminate the ociperlimab option, collaboration and license agreement.

Pursuant to the termination agreement, the Company regained full, global rights to develop, manufacture and commercialize ociperlimab.

Upon termination the Company had no further performance obligations under the collaboration, and all remaining deferred revenue balances were recognized in full.

The China broad markets agreement remains in place.

The following table summarizes collaboration revenue recognized in connection with the China broad markets agreement for the three and nine months ended September 30, 2024 and the terminated ociperlimab option, collaboration and license agreement for the three and nine months ended September 30, 2023:

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

Research and development service revenue — 3,569 — 7,153

Right to access intellectual property revenue — 51,978 — 104,475

Material rights revenue — 71,980 71,980

China broad markets agreement 5,154 2,954 13,655 5,590

Total 5,154 130,481 13,655 189,198

Revenue from collaborators 8,749 4,734

In-Licensing Arrangements - Commercial

During the three and nine months ended September 30, 2024 and 2023, the Company recorded the following amounts related to its collaboration arrangement with Amgen.

For a detailed description of the arrangement and related rights and obligation, see the Company’s Form 10-K for the year ended December 31, 2023 filed on February 26, 2024.

Amounts recorded related to the Company’s portion of the co-development funding on the pipeline assets for the three and nine months ended September 30, 2024 and 2023 were as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

Research and development expense 17,015 16,321 52,981 39,595

During the three months ended March 31, 2025 and 2024, the Company recorded the following amounts related to its collaboration arrangement with Amgen.

For a detailed description of the arrangement and related rights and obligation, see the Company’s Annual Report for the year ended December 31, 2024 filed on February 27, 2025.

Amounts recorded related to the Company’s portion of the co-development funding on the pipeline assets for the three months ended March 31, 2025 and 2024 were as follows:

Three Months Ended

BeiGene’s portion of the development funding 40,519 26,620

Amortization of research and development cost share liability 19,812 13,136

Total amount due to Amgen for BeiGene’s portion of the development funding 33,590 32,221 104,595 78,164

September 30, 2024

Research and development expense 20,707 13,484

March 31, 2025

Remaining portion of development funding cap 295,113

As of September 30, 2024 and December 31, 2023, the research and development cost share liability recorded in the Company’s balance sheet was as follows:

September 30, December 31,

As of March 31, 2025 and December 31, 2024, the research and development cost share liability recorded in the Company’s balance sheet was as follows:

March 31, December 31,

Research and development cost share liability, current portion 111,127 111,154

1 unchanged sentence

Total research and development cost share liability 145,628 165,440

The total reimbursement paid under the commercial profit-sharing agreement for product sales is classified in the income statement for the three and nine months ended September 30, 2024 and 2023 as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

The total reimbursement paid under the commercial profit-sharing agreement for product sales is classified in the income statement for the three months ended March 31, 2025 and 2024 as follows:

Three Months Ended

Cost of sales - product 7,494 8,569

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The Company purchases commercial inventory from Amgen to distribute in China.

Inventory purchases amounted to $ 43,061 and $ 152,940 during the three and nine months ended September 30, 2024, respectively, and $ 18,746 and $ 58,023 during the three and nine months ended September 30, 2023, respectively.

Net amounts payable to Amgen was $ 89,482 and $ 55,474 as of September 30, 2024 and December 31, 2023, respectively.

Inventory purchases amounted to $ 62,744 and $ 62,226 during the three months ended March 31, 2025 and 2024, respectively.

Net amounts payable to Amgen was $ 96,997 and $ 116,563 as of March 31, 2025 and December 31, 2024, respectively.

In-Licensing Arrangements - Development

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These arrangements typically include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost-sharing arrangements, royalty payments, and profit sharing.

Upfront and milestone payments incurred under these arrangements for the three and nine months ended September 30, 2024 and 2023 are set forth below.

Upfront and milestone payments incurred under these arrangements for the three months ended March 31, 2025 and 2024 are set forth below.

All upfront and development milestones were expensed to research and development expense.

All regulatory and commercial milestones were capitalized as intangible assets and are being amortized over the remainder of the respective product patent or term of the commercialization agreements.

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

Three Months Ended

Payments due to collaboration partners Classification $ $

1 unchanged sentence

Development milestones incurred Research and development expense — 35,000

Regulatory and commercial milestone payments Intangible asset — 9,379 — 18,612

Total — 35,027

1 unchanged sentence

Restricted Cash

The Company’s restricted cash primarily consists of RMB-denominated cash deposits held in designated bank accounts for collateral for letters of credit.

The Company’s restricted cash primarily consists of RMB-denominated cash deposits held in designated bank accounts as collateral for letters of credit.

The Company classifies restricted cash as current or non-current based on the term of the restriction.

Restricted cash as of September 30, 2024 and December 31, 2023 was as follows:

September 30, December 31,

Restricted cash as of March 31, 2025 and December 31, 2024 was as follows:

March 31, December 31,

Short-term restricted cash 11,333 9,312

1 unchanged sentence

Total 14,180 11,337

In addition to the restricted cash balances above, the Company is required by the PRC securities law to use the proceeds from its offering on the STAR Market of the Shanghai Stock Exchange (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.

As of September 30, 2024, the Company had cash remaining related to the STAR Offering proceeds of $ 787,147 .

In addition to the restricted cash balances above, the Company is required by the PRC securities law to use the proceeds from its offering on the STAR Market of the Shanghai Stock Exchange (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.

As of March 31, 2025, the Company had cash remaining related to the STAR Offering proceeds of $ 461,560 .

Investments in Equity Securities

The following table summarizes the Company’s investments in equity securities:

September 30, December 31,

March 31, December 31,

Equity securities with readily determinable fair values 1

4 unchanged sentences

40,798 40,798

50,370 48,157

Equity-method investments 3

1 unchanged sentence

Total 112,662 124,317

1 Represents common stock and warrants to purchase additional shares of common stock of Leap Therapeutics, Inc.

1 Represents common stock and warrants to purchase additional shares of common stock of Leap.

The Company measures the investment in the common stock and warrants at fair value, with changes in fair value recorded to other income, net.

1 unchanged sentence

The consideration received for the divestiture consisted of preferred stock in a newly formed entity, Pi Health, Inc., with a fair value of $ 40,798 and cash consideration of $ 1,000 .

The transaction resulted in a pre-tax gain of $ 3,735 recorded within other income, net during the nine months ended September 30, 2024.

The Company will account for its investment prospectively as a private equity security without a readily determinable fair value and the divestiture is not treated as a discontinued operation in the Statement of Operations and therefore the historical results of operations of the Pi Health business will remain in the Company’s continuing operations.

The following table summarizes unrealized (losses) gains related to investments in equity securities recorded in other income, net for the three and nine months ended September 30, 2024 and 2023:

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

The transaction resulted in a pre-tax gain of $ 3,735 recorded within other income, net during the three months ended March 31, 2024.

The Company will account for its investment prospectively as a private equity security without a readily determinable fair value, and the divestiture was not treated as a discontinued operation in the Statement of Operations and therefore the historical results of operations of the Pi Health business will remain in the Company’s continuing operations.

3 In the first quarter of 2025, in connection with the wind-down of the operations and related financial obligations of one of the Company’s equity-method investments, the investment’s fair value was assessed to be zero .

The Company recognized an other-than-temporary impairment loss of $ 12,376 during the three months ended March 31, 2025, within unrealized losses from equity-method investments.

The following table summarizes unrealized losses related to investments in equity securities recorded in other income, net for the three months ended March 31, 2025 and 2024:

Three Months Ended

Equity securities with readily determinable fair values

5 unchanged sentences

The Company’s inventories, net consisted of the following:

September 30, December 31,

March 31, December 31,

Raw materials 177,308 170,584

4 unchanged sentences

Property, plant and equipment, net are recorded at cost and consisted of the following:

September 30, December 31,

March 31, December 31,

Land 65,485 65,485

9 unchanged sentences

The Company has made a significant investment in its newly opened manufacturing and R&D center in Hopewell, New Jersey.

In the three months ended September 30, 2024, $ 256,570 of assets were placed into service.

As of September 30, 2024, the Company had construction in progress of $ 473,833 related to the Hopewell facility, the majority of which will be put into service in the first quarter of 2025.

In March 2024, the Company acquired a land use right and the facility currently being constructed on the land for $ 75,986 .

The Company plans to complete the construction of the facility and build a research and development center on the land.

Based on the relative fair values of the land use right and construction in progress, $ 29,721 of the total purchase price was allocated to the land use right and $ 46,265 was allocated to the construction in progress.

In May 2024, the Company acquired additional construction in progress in connection with the properties for $ 23,443 .

As of September 30, 2024, title of the land use right was being transitioned to the Company.

As such, the purchase price allocated to the land use right was recorded as a long-term prepaid as of September 30, 2024 and will be transferred to operating lease right-of-use asset upon the closing of the transaction.

Depreciation expense was $ 70,028 and $ 117,892 for the three and nine months ended September 30, 2024, respectively, and $ 19,242 and $ 59,574 for the three and nine months ended September 30, 2023, respectively.

Included within depreciation expense for the three and nine months ended September 30, 2024 is $ 41,808 of accelerated depreciation expense resulting from the move of production to more efficient, larger scale equipment for tislelizumab.

In the three months ended March 31, 2025, $ 99,160 of assets were placed into service.

As of March 31, 2025, the Company had construction in progress of $ 421,727 related to the Hopewell facility, the majority of which will be put into service in 2025.

Depreciation expense was $ 31,614 and $ 24,110 for the three months ended March 31, 2025 and 2024, respectively.

Intangible Assets

Intangible assets as of September 30, 2024 and December 31, 2023 are summarized as follows:

September 30, 2024 December 31, 2023

Intangible assets as of March 31, 2025 and December 31, 2024 are summarized as follows:

March 31, 2025 December 31, 2024

carrying Accumulated Intangible carrying Accumulated Intangible

10 unchanged sentences

Amortization expense was as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

Three Months Ended

Amortization expense - Cost of sales - product

1,186 981 3,546 2,620

Amortization expense - Selling, general and administrative

78 1,287 78 1,662

Total 1,190 1,183

Estimated amortization expense for each of the five succeeding years and thereafter, as of September 30, 2024 is as follows:

As of March 31, 2025, estimated amortization expense for each of the five succeeding years and thereafter was as follows:

Year Ending December 31, Cost of Sales - Product Selling, General and Administrative Total

7 unchanged sentences

Total 49,579 560 50,139

Income tax expense was $ 23,046 and $ 45,255 for the three and nine months ended September 30, 2024, respectively, and $ 13,925 and $ 39,091 for the three and nine months ended September 30, 2023, respectively.

The income tax expense for the three and nine months ended September 30, 2024 and 2023 was primarily attributable to current U.S.

tax expense determined after other special tax deductions and research and development tax credits, current Switzerland tax expense based on year to date earnings, and current China tax expense due to certain non-deductible expenses.

Income tax expense was $ 19,630 and $ 7,724 for the three months ended March 31, 2025 and 2024, respectively.

The income tax expense for the three months ended March 31, 2025 and 2024 was primarily attributable to current U.S.

tax expense determined after other special tax deductions and research and development tax credits, current Switzerland tax expense based on year to date earnings, current China tax expense due to certain non-deductible expenses, and other intercompany discrete adjustments.

On a quarterly basis, the Company evaluates the realizability of deferred tax assets by jurisdiction and assesses the need for a valuation allowance.

1 unchanged sentence

Valuation allowances have been provided on deferred tax assets where, based on all available evidence, it was considered more likely than not that some portion or all of the recorded deferred tax assets will not be realized in future periods.

After consideration of all positive and negative evidence, as of September 30, 2024, the Company will maintain a full valuation allowance against its net deferred tax assets.

As of September 30, 2024, the Company had gross unrecognized tax benefits of $ 17,592 .

After consideration of all positive and negative evidence, as of March 31, 2025, the Company will maintain a full valuation allowance against its net deferred tax assets.

As of March 31, 2025, the Company had gross unrecognized tax benefits of $ 17,575 .

The Company does not anticipate that the amount of existing unrecognized tax benefits will significantly change within the next 12 months.

The Company’s reserve for uncertain tax positions increased by $ 1,788 and $ 3,328 in the three and nine months ended September 30, 2024 primarily due to U.S.

The Company’s reserve for uncertain tax positions increased by $ 336 in the three months ended March 31, 2025, primarily due to U.S.

federal and state tax credits and incentives.

1 unchanged sentence

Prepaid expenses and other current assets consist of the following:

September 30, December 31,

March 31, December 31,

Prepaid research and development costs 44,126 64,277

Prepaid taxes 25,048 37,320

Other receivables 28,738 32,828

Prepaid manufacturing cost 28,849 42,066

Prepaid taxes 25,347 23,792

Prepaid general and administrative expenses 16,661 21,253

Prepaid manufacturing cost 13,795 19,333

Short-term restricted cash 11,333 9,312

Deposits 7,860 26,753

Prepaid insurance 7,142 6,242

2 unchanged sentences

Other non-current assets consist of the following:

September 30, December 31,

Prepayment of property and equipment 1

March 31, December 31,

Long-term investments 121,144 128,933

Prepaid supply cost 12,239 12,249

Rental deposits and other 7,173 8,481

Prepayment of property and equipment 3,426 5,927

Prepaid VAT 3,062 2,875

Long-term restricted cash 2,847 2,025

Long-term investments (Note 4) 138,234 89,644

Total 149,891 160,490

1 Includes payment for acquired land use right that was in the process of being transitioned to the Company as of September 30, 2024 (See Note 6).

Accrued expenses and other payables consist of the following:

September 30, December 31,

March 31, December 31,

Revenue rebates and returns related 259,944 235,600

1 unchanged sentence

External research and development activities related 91,579 154,269

Commercial activities 80,810 87,572

Individual income tax and other taxes 80,900 34,904

Commercial activities 76,815 77,530

Accrued general and administrative expenses 32,139 31,106

2 unchanged sentences

Other long-term liabilities consist of the following:

September 30, December 31,

March 31, December 31,

Deferred government grant income 29,833 30,324

3 unchanged sentences

Total 65,629 66,735

The following table summarizes the Company’s short-term and long-term debt obligations as of September 30, 2024 and December 31, 2023:

Lender Line of Credit Term Maturity Date Interest Rate As of

September 30, 2024 December 31, 2023

China Construction Bank RMB 580,000 9 -year

The following table summarizes the Company’s short-term and long-term debt obligations as of March 31, 2025 and December 31, 2024:

Lender Borrower Term Maturity Date Note As of

March 31, 2025 December 31, 2024

China Construction Bank BeiGene Guangzhou Biologics Manufacturing Co., Ltd.

June 11, 2027 1 16,536 16,440

China Merchants Bank RMB 350,000 9 -year

China Merchants Bank BeiGene Guangzhou Biologics Manufacturing Co., Ltd.

January 20, 2029 2 8,662 8,611

China Merchants Bank RMB 378,000 9 -year

China Merchants Bank BeiGene Guangzhou Biologics Manufacturing Co., Ltd.

November 8, 2029 3 8,188 8,148

China Merchants Bank $ 380,000 1 -year

China CITIC Bank BeiGene (Suzhou) Co., Ltd.

July 28, 2032 4 4,479 1,384

China Merchants Bank BeiGene, Ltd.

5 380,000 380,000

China Minsheng Bank $ 150,000 1 -year

China Minsheng Bank BeiGene, Ltd.

December 16, 2025 6 150,000 150,000

China Industrial Bank RMB 675,000 364 -day

China Industrial Bank BeiGene, Ltd.

March 27, 2025 7 — 92,475

China Merchants Bank RMB 400,000 1 -year

China Merchants Bank BeiGene Guangzhou Biologics Manufacturing Co., Ltd.

June 5, 2025 8 55,120 54,800

HSBC Bank RMB 340,000 1 -year

May 5, 2025 6 48,450 340,000 47,903 340,000

China Industrial Bank RMB 200,000 1 -year

HSBC Bank BeiGene, Ltd.

May 5, 2025 9 46,851 46,580

Shanghai Pudong Development Bank RMB 700,000 1 -year

7 2.9 % 99,750 700,000 49,312 350,000

Other short-term debt 8

— — 28,037 199,000

Shanghai Pudong Development Bank BeiGene, Ltd.

November 24, 2025 10 93,634 93,091

Total short-term debt 763,470 851,529

China Construction Bank RMB 580,000 9 -year

China Construction Bank BeiGene Guangzhou Biologics Manufacturing Co., Ltd.

June 11, 2027 1 41,340 41,100

China Merchants Bank RMB 350,000 9 -year

China Merchants Bank BeiGene Guangzhou Biologics Manufacturing Co., Ltd.

January 20, 2029 2 25,985 27,987

China Merchants Bank RMB 378,000 9 -year

China Merchants Bank BeiGene Guangzhou Biologics Manufacturing Co., Ltd.

November 8, 2029 3 31,166 33,020

China CITIC Bank RMB 480,000 10 -year

China CITIC Bank BeiGene (Suzhou) Co., Ltd.

July 28, 2032 4 61,666 64,377

Total long-term bank loans 187,513 1,315,880 197,618 1,402,643

1 The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC.

The loan interest rate was 4.2 % as of September 30, 2024.

The loan is secured by BeiGene Guangzhou Factory’s property ownership certificate and fixed assets.

The Company repaid $ 6,886 (RMB 50,000 ) during the nine months ended September 30, 2024.

2 The outstanding borrowings bear floating interest rates benchmarking against prevailing interest rates of certain PRC financial institutions.

The loan interest rate was 3.7 % as of September 30, 2024.

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.

The Company repaid $ 6,526 (RMB 47,143 ) during the nine months ended September 30, 2024.

3 The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC.

The loan interest rate was 3.8 % as of September 30, 2024.

The loan is secured by fixed assets placed into service upon completion of the third phase of the Guangzhou manufacturing facility’s build out.

The Company repaid $ 4,169 (RMB 30,000 ) during the nine months ended September 30, 2024.

4 The outstanding borrowings bear floating interest rates benchmarking the secured overnight financing rate.

The loan interest rate was 6.7 % as of September 30, 2024.

$ 300,000 of the borrowings matures on December 25, 2024, and $ 80,000 matures on January 27, 2025.

5 The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC.

The loan interest rate was 2.6 % as of September 30, 2024.

6 The outstanding borrowings bear floating interest rates benchmarking Hong Kong interbank market rate for RMB.

The loan interest rate was 5.7 % as of September 30, 2024.

7 $ 49,875 (RMB 350,000 ) of the outstanding borrowings matures on November 21, 2024 and March 19, 2025, respectively.

8 During the two years ended December 31, 2023, the Company entered into short-term working capital loans with China Industrial Bank and China Merchants Bank to borrow up to RMB 875,000 in aggregate.

The Company repaid $ 27,476 (RMB 199,000 ) during the nine months ended September 30, 2024.

9 In July 2022, the Company entered into a 10 -year bank loan agreement with China CITIC Bank to borrow up to RMB 480,000 at a floating interest rate benchmarked against prevailing interest rates of certain PRC financial institutions.

The Company drew down $ 9,053 (RMB 65,000 ) during the nine months ended September 30, 2024.

The weighted average loan interest rate was 3.7 % as of September 30, 2024.

Total long-term debt 160,157 166,484

1 The credit facility offers a borrowing capacity of RMB 580,000 , denominated in RMB, and bears floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC.

The loan interest rate was 4.2 % as of March 31, 2025.

The loan is secured by BeiGene Guangzhou Biologics Manufacturing Co., Ltd.’s property ownership certificate and fixed assets.

2 The credit facility offers a borrowing capacity of RMB 350,000 , denominated in RMB, and bears floating interest rates benchmarking against prevailing interest rates of financial institutions in the PRC.

The loan interest rate was 3.7 % as of March 31, 2025.

The Company repaid $ 2,161 (RMB 15,715 ) during the three months ended March 31, 2025.

The loan is secured by Guangzhou Factory’s second land use right and certain fixed assets.

3 The credit facility offers a borrowing capacity of RMB 378,000 , denominated in RMB, and bears floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC.

The loan interest rate was 3.3 % as of March 31, 2025.

The Company repaid $ 2,054 (RMB 14,910 ) during the three months ended March 31, 2025.

The loan is secured by fixed assets to be placed into service upon completion of the third phase of the Guangzhou manufacturing facility’s build out.

4 The credit facility offers a borrowing capacity of RMB 480,000 , denominated in RMB, and bears floating interest rate benchmarking RMB loan interest rates of financial institutions in the PRC.

The loan interest rate was 3.6 % as of March 31, 2025.

The loan is secured by BeiGene (Suzhou) Co., Ltd.’s property ownership certificate of the small molecule manufacturing campus in Suzhou, China.

5 The working capital loan facility offers a borrowing capacity of up to $ 380,000 , denominated in USD, and bears floating interest rates benchmarking the secured overnight financing rate.

The loan interest rate was 6.2 % as of March 31, 2025.

$ 300,000 of the borrowings matures on December 17, 2025, and $ 80,000 matures on January 21, 2026.

6 The working capital loan facility offers a borrowing capacity of up to $ 150,000 , denominated in USD.

The loan interest rate was 6.8 % as of March 31, 2025.

7 The working capital loan facility offered a borrowing capacity of up to RMB 675,000 , denominated in RMB.

The Company repaid the principal during the three months ended March 31, 2025.

8 The working capital loan facility offers a borrowing capacity of up to of RMB 400,000 , denominated in RMB.

The loan interest rate was 3.0 % as of March 31, 2025.

9 The working capital loan facility offers a borrowing capacity of up to RMB 340,000 , denominated in RMB, and bears floating interest rates benchmarking Hong Kong interbank market rate for RMB.

The loan interest rate was 5.2 % as of March 31, 2025.

10 The working capital loan facility offers a borrowing capacity of up to RMB 700,000 , denominated in RMB.

The loan interest rate was 2.9 % as of March 31, 2025

The Company has numerous financial and non-financial covenants on its debt obligations with various banks and other lenders.

Some of these covenants include cross-default provisions that could require acceleration of repayment of loans in the event of default.

Some of these covenants include default and/or cross-default provisions that could require acceleration of repayment of loans in the event of default.

However, the Company’s debt is primarily short-term in nature.

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.

As of September 30, 2024, the Company was in compliance with all covenants of its material debt agreements.

As of March 31, 2025, the Company was in compliance with all covenants of its material debt agreements.

Interest Expense

Interest expense recognized for the three and nine months ended September 30, 2024 was $ 14,312 and $ 39,949 , respectively, among which, $ 8,176 and $ 25,697 was capitalized, respectively.

Interest expense recognized for the three and nine months ended September 30, 2023 was $ 6,630 and $ 16,095 , respectively, among which, $ 11,632 and $ 12,404 was capitalized, respectively.

Interest expense recognized for the three months ended March 31, 2025 and 2024 was $ 12,961 and $ 12,404 , respectively, among which, $ 5,959 and $ 9,209 was capitalized, respectively.

Interest paid for the three months ended March 31, 2025 and 2024, net of amounts capitalized, amounted to $ 6,247 and $ 2,269 , respectively.

Product Revenue

The Company’s product revenue is primarily derived from the sale of its internally developed products BRUKINSA in the U.S., Europe, China, and other regions, and tislelizumab in China;

The Company’s product revenue is primarily derived from the sale of its internally developed products BRUKINSA ® and TEVIMBRA ® in the U.S., China, EU, and other regions;

XGEVA ® , BLINCYTO ® and KYPROLIS ® in China under a license from Amgen;

and POBEVCY ® in China under a license from Bio-Thera.

The table below presents the Company’s net product revenue for the three and nine months ended September 30, 2024 and 2023.

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

The table below presents the Company’s net product revenue for the three months ended March 31, 2025 and 2024.

Three Months Ended

Product revenue – gross 1,400,066 944,464

1 unchanged sentence

Product revenue – net 1,108,530 746,918

The following table disaggregates net product revenue by product for the three and nine months ended September 30, 2024 and 2023:

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

The following table disaggregates net product revenue by product for the three months ended March 31, 2025 and 2024:

Three Months Ended

791,664 488,515

Tislelizumab 163,351 144,352 467,038 408,666

171,164 145,277

5 unchanged sentences

Total product revenue – net 1,108,530 746,918

The following table presents the roll-forward of accrued revenue rebates and returns for the nine months ended September 30, 2024 and 2023:

Nine Months Ended

September 30,

Balance at beginning of the period 139,936 41,817

The following table presents the roll-forward of accrued revenue rebates and returns for the three months ended March 31, 2025 and 2024:

Rebates, Returns and Other Deductions Contra AR Accruals Total

Balance at December 31, 2024 235,600 50,699 286,299

Accrual 130,027 161,509 291,536

Payments ( 105,683 ) ( 177,050 ) ( 282,733 )

Balance at end of the period 213,747 112,256

(Loss) Earnings Per Share

The following table reconciles the numerator and denominator in the computations of basic and diluted (loss) earnings per share:

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

Net (loss) income ( 121,350 ) 215,413 ( 492,905 ) ( 514,155 )

Balance at March 31, 2025 259,944 35,158 295,102

Balance at December 31, 2023 139,936 30,435 170,371

Accrual 104,444 93,102 197,546

Payments ( 58,103 ) ( 94,834 ) ( 152,937 )

Balance at March 31, 2024 186,277 28,703 214,980

Earnings (Loss) Per Share/ADS

The following table reconciles the numerator and denominator in the computations of earnings (loss) per share/ADS:

Three Months Ended

Net income (loss) 1,270 ( 251,150 )

Weighted-average shares outstanding—basic 1,390,052,966 1,355,547,626

Effect of dilutive securities:

Stock options, restricted stock units and ESPP shares — 29,615,554 — —

Dilutive common share equivalents 55,200,253 —

Weighted-average shares outstanding—diluted 1,445,253,219 1,355,547,626

(Loss) earnings per share

Antidilutive common share equivalents excluded from above 1,408,376 —

Earnings (loss) per share:

Basic 0.00 ( 0.19 )

Diluted 0.00 ( 0.19 )

For the three and nine months ended September 30, 2024 and the nine months ended September 30, 2023, the computation of basic loss per share using the two-class method was not applicable as the Company was in a net loss position, and the effects of all share options, restricted shares, restricted share units and ESPP shares were excluded from the calculation of diluted loss per share, as their effect would have been anti-dilutive.

For the three months ended September 30, 2023, diluted earnings per share was computed using the weighted-average number of ordinary shares and the effect of potentially dilutive shares outstanding during the periods.

Earnings (loss) per ADS:

Basic 0.01 ( 2.41 )

Diluted 0.01 ( 2.41 )

For the three months ended March 31, 2025, diluted earnings per share was computed using the weighted-average number of ordinary shares and the effect of potentially dilutive shares outstanding during the periods.

Potentially dilutive shares consist of stock options, restricted stock units and ESPP shares.

The dilutive effect of outstanding stock options, restricted stock units and ESPP shares is reflected in diluted net earnings per share by application of the treasury stock method.

The dilutive effect of outstanding stock options, restricted stock units and ESPP shares is reflected in diluted net earnings per share using the treasury stock method.

For the three months ended March 31, 2024, the Company was in a net loss position and the effects of all share options, restricted share units and ESPP shares were excluded from the calculation of diluted loss per share, as their effect would have been anti-dilutive.

Each ADS represents 13 ordinary shares.

Basic and diluted earnings (loss) per ADS was derived from the basic and diluted earnings (loss) per share, respectively.

Share-Based Compensation Expense

Share Option and Incentive Plan

During the nine months ended September 30, 2024, the Company granted options for 9,035,663 ordinary shares, restricted share units for 45,696,365 ordinary shares, and performance share units for 2,405,949 ordinary shares under the Company’s share option and incentive plan.

As of September 30, 2024, options, restricted share units, and performance share units for ordinary shares outstanding totaled 65,461,567 , 85,279,987 , and 2,162,082 , respectively.

As of September 30, 2024, share-based awards to acquire 82,344,989 ordinary shares were available for future grant under the Company’s share option and incentive plan.

During the three months ended March 31, 2025, the Company granted options for 132,314 ordinary shares and restricted share units for 2,225,184 ordinary shares under the Company’s share option and incentive plan.

As of March 31, 2025, options, restricted share units, and performance share units for ordinary shares outstanding totaled 58,342,609 , 81,602,677 , and 2,131,090 , respectively.

As of March 31, 2025, share-based awards to acquire 84,560,865 ordinary shares were available for future grant under the Company’s share option and incentive plan.

Employee Share Purchase Plan

1 unchanged sentence

Eligible employees are able to authorize payroll deductions of up to 10 % of their eligible earnings, subject to applicable limitations.

As of September 30, 2024, 4,953,682 ordinary shares were available for future issuance under the ESPP.

The following tables summarizes the shares issued under the ESPP:

As of March 31, 2025, 3,998,286 ordinary shares were available for future issuance under the ESPP.

The following table summarizes the shares issued under the ESPP:

Market Price 1

1 unchanged sentence

Issuance Date Number of Ordinary Shares Issued ADS Ordinary ADS Ordinary Proceeds

August 31, 2024 1,035,996 $ 165.02 $ 12.69 $ 140.27 $ 10.78 $ 11,178

February 28, 2025 955,396 $ 188.26 $ 14.48 $ 160.02 $ 12.31 $ 11,760

4 unchanged sentences

Share-Based Compensation Expense

The following table summarizes total share-based compensation expense recognized for the three and nine months ended September 30, 2024 and 2023:

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

The following table summarizes total share-based compensation expense recognized for the three months ended March 31, 2025 and 2024:

Three Months Ended

Research and development 41,767 38,045

3 unchanged sentences

The movement of accumulated other comprehensive loss was as follows:

Foreign Currency Gains/(Losses) on Pension

Translation Available-for-Sale Liability

Adjustments Securities Adjustments Total

Foreign Currency Pension

Translation Liability

Adjustments Adjustments Total

Balance as of December 31, 2024 ( 135,552 ) ( 13,436 ) ( 148,988 )

Other comprehensive income (loss) before reclassifications 15,348 ( 35 ) — 15,313

Other comprehensive income before reclassifications 6,441 — 6,441

Amounts reclassified from accumulated other comprehensive loss — 226 226

Net-current period other comprehensive income (loss) 15,348 ( 35 ) 608 15,921

Balance as of September 30, 2024 ( 72,639 ) — ( 10,886 ) ( 83,525 )

Shareholders’ Equity

BMS Settlement

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.

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.

In consideration for the shares being returned, the Company agreed to drop its claims pursuant to the Settlement Agreement.

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.

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.

The receipt of the shares occurred on August 15, 2023.

The Company recorded a noncash gain upon receipt of $ 362,917 , which represents the fair value on the day the shares were received.

The gain was recorded within other income, net in the consolidated statements of operations.

The shares were constructively retired as of December 31, 2023.

The Company recorded the amount of the cancelled shares in excess of par to additional paid-in capital.

Net-current period other comprehensive income 6,441 226 6,667

Balance as of March 31, 2025 ( 129,111 ) ( 13,210 ) ( 142,321 )

Restricted Net Assets

8 unchanged sentences

Foreign exchange and other regulations in the PRC may further restrict the Company’s PRC subsidiaries from transferring funds to the Company in the form of dividends, loans and advances.

As of September 30, 2024 and December 31, 2023, the net cash of the Company’s PRC subsidiaries amounted to $ 1,391,444 and $ 1,837,790 , respectively .

As of March 31, 2025 and December 31, 2024, amounts restricted were the net assets of the Company’s PRC subsidiaries, which, after intercompany eliminations, amounted to $ 1,793,330 and $ 1,709,961 , respectively .

Commitments and Contingencies

Purchase Commitments

As of September 30, 2024, the Company had non-cancellable purchase commitments amounting to $ 155,852 , of which $ 29,955 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $ 125,897 related to binding purchase obligations of inventory from Amgen.

As of March 31, 2025, the Company had non-cancellable purchase commitments amounting to $ 152,905 , of which $ 30,998 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $ 121,907 related to binding purchase obligations of inventory from Amgen.

The Company does not have any minimum purchase requirements for inventory from Amgen.

Capital Commitments

The Company had capital commitments amounting to $ 66,151 for the acquisition of property, plant and equipment as of September 30, 2024, related to various facilities across the globe, including the manufacturing and clinical R&D campus in Hopewell, New Jersey.

The Company had capital commitments amounting to $ 56,293 for the acquisition of property, plant and equipment as of March 31, 2025, related to various facilities across the globe, including the manufacturing and clinical R&D campus in Hopewell, New Jersey.

Co-Development Funding Commitment

Under the Amgen Collaboration Agreement, the Company is responsible for co-funding global development costs for the Amgen oncology pipeline assets up to a total cap of $ 1,250,000 .

The Company is funding its portion of the co-development costs by contributing cash and development services.

As of September 30, 2024, the Company’s remaining co-development funding commitment was $ 379,057 .

The Company is funding its portion of the co-development costs by contributing cash and/or development services.

As of March 31, 2025, the Company’s remaining co-development funding commitment was $ 295,113 .

Funding Commitment

The Company had committed capital related to two equity-method investments in the amount of $ 15,053 .

As of September 30, 2024, the remaining capital commitment was $ 8,156 and is expected to be paid from time to time over the investment period.

As of March 31, 2025, the remaining capital commitment was $ 5,904 and is expected to be paid from time to time over the investment period.

Segment and Geographic Information

2 unchanged sentences

Its chief operating decision maker is the Chief Executive Officer, who makes operating decisions, assesses performance and allocates resources on a consolidated basis.

The primary measure of segment profitability for the Company’s operating segment is considered to be consolidated net income (loss).

Significant segment expenses reviewed by the CODM on a regular basis included within net income (loss) include cost of product sales, research and development expenses and selling, general and administrative expenses which are separately presented on the Company’s Consolidated Statements of Operations.

Other segment items within net income (loss) include interest income, net, other income, net and income tax expense.

The Company’s long-lived assets are primarily located in the U.S.

1 unchanged sentence

Total revenues by geographic area are presented as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

Three Months Ended

- total revenue 567,211 351,456

12 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.

What changed 10-Q

Item 1. Financial Statements