What changed in this filing

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Item 1. Financial Statements

2023-11-09 compared with 2023-08-02 · 293 added, 311 removed, 588 unchanged (51% of the section changed)

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

June 30, December 31,

September 30, December 31,

Note 2023 2022

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Accounts receivable, net 309,079 173,168

Inventories 6 321,333 282,346

Inventories, net 5 316,929 282,346

Prepaid expenses and other current assets 9 241,661 216,553

Total current assets 4,053,542 5,207,078

Long-term restricted cash 5 1,513 5,277

Property, plant and equipment, net 6 1,178,038 845,946

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Commitments and contingencies 17

Shareholders' equity:

Ordinary shares, US$ 0.0001 par value per share;

9,500,000,000 shares authorized;

1,376,251,336 and 1,356,140,180 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively

1,352,997,624 and 1,356,140,180 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

Additional paid-in capital 11,502,527 11,540,979

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Accumulated deficit ( 7,594,497 ) ( 7,080,342 )

Total equity 3,798,559 4,383,355

Total liabilities and equity 5,728,736 6,379,290

Total shareholders' equity 3,763,234 4,383,355

Total liabilities and shareholders' equity 5,524,879 6,379,290

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

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

Three Months Ended Six Months Ended

June 30, June 30,

Three Months Ended Nine Months Ended

September 30, September 30,

Note 2023 2022 2023 2022

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Interest income, net 26,649 12,759 57,735 34,261

Other expense, net ( 63,818 ) ( 129,617 ) ( 45,515 ) ( 117,650 )

Loss before income taxes ( 367,463 ) ( 557,585 ) ( 704,402 ) ( 978,834 )

Other income (expense), net 336,657 ( 125,640 ) 291,142 ( 243,290 )

Income (loss) before income taxes 229,338 ( 551,238 ) ( 475,064 ) ( 1,530,072 )

Income tax expense 8 13,925 6,318 39,091 28,408

Net loss ( 381,137 ) ( 565,726 ) ( 729,568 ) ( 1,000,924 )

Net loss per share ( 0.28 ) ( 0.42 ) ( 0.54 ) ( 0.75 )

Weighted-average shares outstanding—basic and diluted 1,360,224,377 1,336,463,026 1,357,211,308 1,334,252,648

Net loss per American Depositary Share (“ADS”) ( 3.64 ) ( 5.50 ) ( 6.99 ) ( 9.75 )

Weighted-average ADSs outstanding—basic and diluted 104,632,644 102,804,848 104,400,870 102,634,819

Net income (loss) 215,413 ( 557,556 ) ( 514,155 ) ( 1,558,480 )

Earnings (loss) per share

Basic 12 0.16 ( 0.41 ) ( 0.38 ) ( 1.16 )

Diluted 12 0.15 ( 0.41 ) ( 0.38 ) ( 1.16 )

Weighted-average shares outstanding—basic 1,360,716,279 1,345,303,747 1,358,392,470 1,337,976,853

Weighted-average shares outstanding—diluted 1,390,331,833 1,345,303,747 1,358,392,470 1,337,976,853

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

Basic 12 2.06 ( 5.39 ) ( 4.92 ) ( 15.14 )

Diluted 12 2.01 ( 5.39 ) ( 4.92 ) ( 15.14 )

Weighted-average ADSs outstanding—basic 104,670,483 103,484,904 104,491,728 102,921,296

Weighted-average ADSs outstanding—diluted 106,948,603 103,484,904 104,491,728 102,921,296

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

BEIGENE, LTD.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(Amounts in thousands of U.S.

Dollars (“$”))

Three Months Ended Six Months Ended

June 30, June 30,

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

Net loss ( 381,137 ) ( 565,726 ) ( 729,568 ) ( 1,000,924 )

Net income (loss) 215,413 ( 557,556 ) ( 514,155 ) ( 1,558,480 )

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

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Unrealized holding income (loss), net 1,315 1,253 8,218 ( 11,062 )

Comprehensive loss ( 465,810 ) ( 665,630 ) ( 795,838 ) ( 1,101,324 )

Comprehensive income (loss) 214,169 ( 636,629 ) ( 581,669 ) ( 1,737,953 )

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

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Dollars (“$”))

Six Months Ended June 30,

Nine Months Ended September 30,

Note 2023 2022

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Unrealized losses on equity investments 4 12,273 16,413

Acquired in-process research and development 15,000 20,000

Amortization of research and development cost share liability 3 ( 38,569 ) ( 70,389 )

Deferred income tax (expense) benefits ( 15 ) 555

Deferred income tax benefits 735 380

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

Other items, net 822 7,762

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Proceeds from option exercises and employee share purchase plan 52,352 35,677

Net cash provided by (used in) financing activities 146,212 ( 28,847 )

Net cash provided by financing activities 69,430 91,395

Effect of foreign exchange rate changes, net ( 50,348 ) ( 133,929 )

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Income taxes paid 42,516 25,006

Interest paid 10,015 12,899

Interest expense paid 15,893 19,865

Supplemental non-cash information:

Capital expenditures included in accounts payable and accrued expenses 107,611 47,310

Acquired intangible asset included in accounts payable 9,384 —

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

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Dollars (“$”), except for number of shares)

Attributable to BeiGene, Ltd.

Ordinary Shares Additional

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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 December 31, 2021 1,334,804,281 133 11,191,007 17,950 ( 5,076,527 ) 6,132,563

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Balance at June 30, 2022 1,349,639,725 134 11,356,686 ( 82,450 ) ( 6,077,451 ) 5,196,919

Use of shares reserved for share option exercises ( 3,971,942 ) — — — — —

Exercise of options, ESPP and release of RSUs 3,972,397 1 16,704 — — 16,705

Share-based compensation — — 78,176 — — 78,176

Other comprehensive loss — — — ( 79,073 ) — ( 79,073 )

Net loss — — — — ( 557,556 ) ( 557,556 )

Balance at September 30, 2022 1,349,640,180 135 11,451,566 ( 161,523 ) ( 6,635,007 ) 4,655,171

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

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The Company currently has three approved medicines that were internally discovered and developed, including BRUKINSA ® , a small molecule inhibitor of Bruton’s Tyrosine Kinase for the treatment of various blood cancers;

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

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

and pamiparib, a selective small molecule inhibitor of PARP1 and PARP2.

The Company has obtained approvals to market BRUKINSA in the United States, the People's Republic of China (“China” or the “PRC”), the European Union, the United Kingdom, Canada, Australia and additional international markets, and tislelizumab and pamiparib in China.

tislelizumab in the European Union and China;

and pamiparib in China.

By leveraging its strong commercial capabilities, the Company has in-licensed the rights to distribute an additional 14 approved medicines for the China market.

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The Company has built, and is expanding, its internal manufacturing capabilities.

The Company is building a commercial-stage biologics manufacturing and clinical R&D center in New Jersey, in addition to its state-of-the-art biologic and small molecule manufacturing facilities in China to support current and potential future demand of its medicines.

The Company is building a commercial-stage biologics manufacturing and clinical R&D center 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 global contract manufacturing organizations (“CMOs”) to manufacture its internally developed clinical and commercial products.

Since its inception in 2010, the Company has become a fully integrated global organization of over 10,000 employees worldwide, including the United States, China, Europe and Australia.

Since its inception in 2010, the Company has become a fully integrated global organization of over 10,000 employees worldwide, primarily in the United States, China and Europe.

Basis of presentation and consolidation

The accompanying condensed consolidated balance sheet as of June 30, 2023, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2023 and 2022, the condensed consolidated statements of cash flows for the six months ended June 30, 2023 and 2022, and the condensed consolidated statements of shareholders' equity for the three and six months ended June 30, 2023 and 2022, and the related footnote disclosures are unaudited.

The accompanying condensed consolidated balance sheet as of September 30, 2023, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, the condensed consolidated statements of cash flows for the nine months ended September 30, 2023 and 2022, and the condensed consolidated statements of shareholders' equity for the three and nine months ended September 30, 2023 and 2022, 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 interim 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 six months ended June 30, 2023 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 and nine months ended September 30, 2023 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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Actual results could differ from these estimates.

Revision of prior period financial statements

The Company evaluates the recoverability of its deferred tax assets on a jurisdiction-by-jurisdiction basis by assessing the adequacy of future expected taxable income from all sources, including reversal of temporary differences, forecasted operating earnings and available tax planning strategies in accordance with ASC 740.

This assessment is subject to a high degree of subjectivity, as the sources of income rely heavily on estimates that are based on a number of factors, including historical experience and short-range and long-range business forecasts.

A valuation allowance is provided when the Company determines that it is more-likely-than-not that some portion or all of a deferred tax asset will not be realized.

Prior to the third quarter of 2022, the Company determined that the majority of its net deferred tax assets (primarily in the U.S.) were realizable on a more-likely-than-not basis, primarily due to cumulative pre-tax income at the taxpaying entity and the weighting of available positive and negative evidence.

Accordingly, no valuation allowance was previously recorded related to those deferred tax assets.

In October 2022, in connection with the preparation of its condensed consolidated financial statements for the three and nine months ended September 30, 2022, the Company reassessed its position on the realizability of its net deferred tax assets and determined that the negative evidence associated with cumulative losses at the consolidated financial statement level are not able to be overcome by other positive evidence, and therefore, a valuation allowance should be applied to its net deferred tax asset balance.

The Company determined the previous conclusion to not apply a valuation allowance to certain net deferred tax assets was an error.

In accordance with Staff Accounting Bulletin (SAB) No.

99, “Materiality,” and SAB No.

108, “Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements,” the Company evaluated the error and determined that the related impact was not material to any of its previously issued financial statements, but that correcting the cumulative impact of the error would be significant to its statements of operations for the three and nine months ended September 30, 2022.

Accordingly, the Company has revised the three and six months ended June 30, 2022 condensed consolidated financial statements and related notes included herein to record a valuation allowance against the Company’s net deferred tax asset balance for all periods presented.

A summary of revisions to previously reported financial statements is presented in Note 2, Revision of Prior Period Financial Statements.

Note 9, Income Taxes and Note 13, Loss Per Share have been updated to reflect the revision.

The Company will also correct previously reported financial information for this error in its future filings, as applicable.

Recent accounting pronouncements

New accounting standards which have not yet been adopted

In March 2023, the FASB issued ASU 2023-01, Leases (Topic 842):

Common Control Arrangements .

This update requires leasehold improvements associated with common control leases be amortized by the lessee over the useful life of the leasehold improvements to the common control group (regardless of the lease term) as long as the lessee controls the use of the underlying asset (the leased asset) through a lease.

However, if the lessor obtained the right to control the use of the underlying asset through a lease with another entity not within the same common control group, the amortization period may not exceed the amortization period of the common control group.

Further, leasehold improvements associated with common control leases be accounted for as a transfer between entities under common control through an adjustment to equity if, and when, the lessee no longer controls the use of the underlying asset.

Those leasehold improvements are subject to the impairment guidance in Topic 360, Property, Plant, and Equipment .

This update is effective for annual periods beginning after December 15, 2023, and early application is permitted.

This guidance should be applied either (i) prospectively to all new leasehold improvements recognized on or after the date of initial application;

(ii) prospectively to all new and existing leasehold improvements recognized on or after the date of initial application, with any remaining unamortized balance of existing leasehold improvements amortized over their remaining useful life to the common control group determined at that date;

or (iii) retrospectively to the beginning of the period in which the entity first applied Topic 842, with any leasehold improvements that otherwise would not have been amortized or impaired recognized through a cumulative-effect adjustment to the opening

balance of retained earnings at the beginning of the earliest period presented in accordance with Topic 842.

The Company does not expect the adoption of this guidance to have a material impact on the Company’s consolidated financial statements.

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, 2022.

There have been no material changes to the Company’s significant accounting policies as of and for the six months ended June 30, 2023, as compared to the significant accounting policies described in the Annual Report.

Revision of Prior Period Financial Statements

As discussed in Note 1, 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 for the three and six months ended June 30, 2022 (See Note 1).

Specifically, a valuation allowance should have been recorded on all net deferred tax assets and such a valuation allowance was not previously recorded.

A summary of revisions to the Company’s previously reported financial statements for the comparative periods presented within this Quarterly Report on Form 10-Q is presented below.

Condensed Consolidated Statements of Operations (unaudited)

Three Months Ended Six Months Ended

June 30, 2022 June 30, 2022

As Reported Adjustments As Revised As Reported Adjustments As Revised

Income tax expense 13,864 ( 5,723 ) 8,141 26,889 ( 4,799 ) 22,090

Net loss ( 571,449 ) 5,723 ( 565,726 ) ( 1,005,723 ) 4,799 ( 1,000,924 )

Net loss per share ( 0.43 ) 0.01 ( 0.42 ) ( 0.75 ) — ( 0.75 )

Net loss per American Depositary Share (“ADS”) ( 5.56 ) 0.06 ( 5.50 ) ( 9.80 ) 0.05 ( 9.75 )

Condensed Consolidated Statements of Comprehensive Loss (unaudited)

Three Months Ended Six Months Ended

June 30, 2022 June 30, 2022

As Reported Adjustments As Revised As Reported Adjustments As Revised

Net loss ( 571,449 ) 5,723 ( 565,726 ) ( 1,005,723 ) 4,799 ( 1,000,924 )

Comprehensive loss ( 671,353 ) 5,723 ( 665,630 ) ( 1,106,123 ) 4,799 ( 1,101,324 )

Condensed Consolidated Statement of Cash Flows (unaudited)

Six Months Ended

June 30, 2022

As Reported Adjustments As Revised

Operating activities:

Net loss ( 1,005,723 ) 4,799 ( 1,000,924 )

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

Deferred income tax benefits 7,550 ( 6,995 ) 555

Changes in operating assets and liabilities:

Other assets 32,315 20 32,335

Accrued expenses and other payables 19,525 1,643 21,168

Other liabilities ( 2,114 ) 533 ( 1,581 )

Net cash used in operating activities ( 616,522 ) — ( 616,522 )

Condensed Consolidated Statement of Stockholders' Equity (unaudited)

Accumulated Deficit Total Equity

As Reported Adjustments As Revised As Reported Adjustments As Revised

Balance at December 31, 2021 ( 4,966,103 ) ( 110,424 ) ( 5,076,527 ) 6,242,987 ( 110,424 ) 6,132,563

Net loss ( 434,274 ) ( 924 ) ( 435,198 ) ( 434,274 ) ( 924 ) ( 435,198 )

Balance at March 31, 2022 ( 5,400,377 ) ( 111,348 ) ( 5,511,725 ) 5,885,500 ( 111,348 ) 5,774,152

Net loss ( 571,449 ) 5,723 ( 565,726 ) ( 571,449 ) 5,723 ( 565,726 )

Balance at June 30, 2022 ( 5,971,826 ) ( 105,625 ) ( 6,077,451 ) 5,302,544 ( 105,625 ) 5,196,919

There have been no material changes to the Company’s significant accounting policies as of and for the nine months ended September 30, 2023, as compared to the significant accounting policies described in the Annual Report.

Fair Value Measurements

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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 June 30, 2023 and December 31, 2022:

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, 2023 and December 31, 2022:

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

As of June 30, 2023 (Level 1) (Level 2) (Level 3)

As of September 30, 2023 (Level 1) (Level 2) (Level 3)

Cash equivalents

Money market funds 616,845 — —

Time deposits 42,348 — —

Short-term investments (Note 4):

Treasury securities 106,989 — —

Prepaid expenses and other current assets (Note 5):

Prepaid expenses and other current assets:

Convertible debt instrument — — 4,668

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Treasury securities 665,251 — —

Prepaid expenses and other current assets (Note 5):

Prepaid expenses and other current assets:

Convertible debt instrument — — 5,190

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The Company has elected the fair value option method of accounting for the convertible notes.

Accordingly, the convertible notes are remeasured at fair value on a recurring basis using Level 3 inputs, with any changes in the fair value option recorded in other income, net.

As of June 30, 2023 and December 31, 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.

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.

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.

The Company recorded a loss on fair value adjustment of $ 283 for the three and nine months ended September 30, 2023, respectively, related to the convertible debt instrument to other income (expense), net in the consolidated statements of operations.

As of September 30, 2023 and December 31, 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.

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.

Collaborative and Licensing Arrangements

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Out-Licensing Arrangements

For the three and six months ended June 30, 2023 and 2022, the Company’s collaboration revenue primarily consisted of research and development services revenue and right to access intellectual property revenue from its collaboration agreements with Novartis for tislelizumab and ociperlimab.

The following table summarizes total collaboration revenue recognized for the three and six months ended June 30, 2023 and 2022:

Three Months Ended Six Months Ended

June 30, June 30,

For the three and nine months ended September 30, 2023 and 2022, 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, 2023 and 2022:

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

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Right to access intellectual property revenue 51,978 26,249 104,475 78,746

Material rights revenue 71,980 — 71,980 —

Other 3,008 2,039 9,157 7,416

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Tislelizumab Collaboration and License

The Company and Novartis have agreed to jointly develop tislelizumab in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals.

In addition, both companies may conduct clinical trials globally to explore combinations of tislelizumab with other cancer treatments, and the Company has an option to co-detail the product in North America, funded in part by Novartis.

In January 2021, the Company entered into a collaboration and license agreement with Novartis, granting Novartis rights to develop, manufacture and commercialize tislelizumab in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia and Japan (“Novartis Territory”).

The Company and Novartis agreed to jointly develop tislelizumab in the Novartis Territory, with Novartis responsible for regulatory submissions and Novartis had the right to commercialization upon regulatory approvals.

In addition, both companies had the ability to conduct clinical trials globally to explore combinations of tislelizumab with other cancer treatments, and the Company was provided with an option to co-detail the product in North America, funded in part by Novartis.

Under the agreement the Company received an upfront cash payment of $ 650,000 from Novartis.

The Company is eligible to receive up to $ 1,300,000 upon the achievement of regulatory milestones, $ 250,000 upon the achievement of sales milestones, and royalties on future sales of tislelizumab in the licensed territory.

Under the terms of the agreement, the Company is responsible for funding ongoing clinical trials of tislelizumab, Novartis has agreed to fund new registrational, bridging, or post-marketing studies in its territory, and each party will be responsible for funding clinical trials evaluating tislelizumab in combination with its own or third party products.

Each party retains the worldwide right to commercialize its propriety products in combination with tislelizumab.

The Company 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.

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.

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.

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and (3) supplying Novartis with required quantities of the tislelizumab drug product, or drug substance, upon receipt of an order from Novartis.

The Company determined that the license, transfer of know-how and use of trademarks are not distinct from each other and represent a single performance obligation.

The tislelizumab R&D services represent a material promise and were determined to be a separate performance obligation at the outset of the agreement as the promise is distinct and has standalone value to Novartis.

The Company evaluated the supply component of the contract and noted the supply will not be provided at a

significant incremental discount to Novartis.

The Company concluded that, for the purpose of ASC 606, the provision related to providing clinical and commercial supply of tislelizumab in the Novartis Territory was an option but not a performance obligation of the Company at the outset of the Novartis collaboration agreement.

A performance obligation for the clinical and commercial supply will be established as quantities of drug product or drug substance are ordered by Novartis.

The Company determined that the license, transfer of know-how and use of trademarks were not distinct from each other and represented a single performance obligation.

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 is distinct and had standalone value to Novartis.

The Company evaluated the supply component of the contract and noted the supply would not be provided at a significant incremental discount to Novartis.

A performance obligation for the clinical and commercial supply would be established as quantities of drug product or drug substance were ordered by Novartis.

The Company determined that the transaction price as of the outset of the arrangement was the upfront payment of $ 650,000 .

The potential milestone payments that the Company is eligible to receive were excluded from the transaction price, as all milestone amounts were fully constrained due to uncertainty of achievement.

The 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.

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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 tislelizumab R&D services.

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 six months ended June 30, 2021.

As such, the Company recognized the entire amount of the transaction price allocated to the license as collaboration revenue during the six months ended June 30, 2021.

The portion of the transaction price allocated to the tislelizumab R&D services was deferred and is being recognized as collaboration revenue as the tislelizumab R&D services are performed using a percentage-of-completion method.

Estimated costs to complete are reassessed on a periodic basis and any updates to the revenue earned are recognized on a prospective basis.

The Company recognized R&D service revenue of $ 11,770 and $ 16,796 during the three and six months ended June 30, 2023, respectively, and $ 9,021 and $ 20,656 during the three and six months ended June 30, 2022, respectively.

The Company also recognized other collaboration revenue of $ 1,344 and $ 5,013 during the three and six months ended June 30, 2023, respectively, and nil and $ 5,377 during the three and six ended June 30, 2022, respectively, related to the sale of tislelizumab clinical supply to Novartis in conjunction with the collaboration.

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 nine months ended September 30, 2021.

As such, the Company recognized the entire amount of the transaction price allocated to the license as collaboration revenue during the nine months ended September 30, 2021.

The portion of the transaction price allocated to the tislelizumab R&D services was deferred and was being recognized as collaboration revenue as the tislelizumab R&D services were performed using a percentage-of-completion method.

Estimated costs to complete were reassessed on a periodic basis and any updates to the revenue earned were recognized on a prospective basis.

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

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.

The Company recognized R&D service revenue of $ 55,483 and $ 72,279 during the three and nine months ended September 30, 2023, respectively, and $ 8,043 and $ 28,699 during the three and nine months ended September 30, 2022, respectively.

The Company also recognized other collaboration revenue of $ 54 and $ 5,067 during the three and nine months ended September 30, 2023, respectively, and $ 2,039 and $ 7,416 during the three and nine ended September 30, 2022, respectively, related to the sale of tislelizumab clinical supply to Novartis in conjunction with the collaboration.

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

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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.

Following option exercise, the Company is eligible to receive up to $ 745,000 upon the achievement of regulatory approval milestones, $ 1,150,000 upon the achievement of sales milestones, and royalties on future sales of ociperlimab in the Novartis Territory.

Subject to the terms of the option, collaboration and license agreement, during the option period, Novartis has agreed to initiate and fund additional global clinical trials with ociperlimab and the Company has agreed to expand enrollment in two ongoing trials.

Following the option exercise, Novartis has agreed to share development costs of global trials.

Following approval, the Company has agreed to provide 50 percent of the co-detailing and co-field medical efforts in the United States, and has an option to co-detail up to 25 percent in Canada and Mexico, funded in part by Novartis.

Each party retains the worldwide right to commercialize its propriety products in combination with ociperlimab, as is the case with tislelizumab under the tislelizumab collaboration and license agreement.

The existing tislelizumab collaboration and license agreement was not modified as a result of the ociperlimab option, collaboration and license agreement.

Following option exercise, the Company was eligible to receive up to $ 745,000 upon the achievement of regulatory approval milestones, $ 1,150,000 upon the achievement of sales milestones, and royalties on future sales of ociperlimab in the Novartis Territory.

Subject to the terms of the option, collaboration and license agreement, during the option period, Novartis agreed to initiate and

fund additional global clinical trials with ociperlimab and the Company agreed to expand enrollment in two ongoing trials.

Following the option exercise, Novartis agreed to share development costs of global trials.

Following approval, the Company agreed to provide 50 percent of the co-detailing and co-field medical efforts in the United States, and had an option to co-detail up to 25 percent in Canada and Mexico, funded in part by Novartis.

Each party retained the worldwide right to commercialize its propriety products in combination with ociperlimab.

The prior tislelizumab collaboration and license agreement was not modified as a result of the ociperlimab option, collaboration and license agreement.

The Company evaluated the Novartis agreements under ASC 606 as the units of account within the agreement represented transactions with a customer.

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The market development activities are considered immaterial in the context of the contracts.

The Company concluded that, at the inception of the agreement, the option for the exclusive product license constitutes a material right as it represents a significant and incremental discount to the fair value of the exclusive product license that Novartis would not have received without entering into the agreement and is therefore considered a distinct performance obligation.

The Company concluded that, at the inception of the agreement, the option for the exclusive product license constituted 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 was therefore considered a distinct performance obligation.

The Company determined that Novartis' right to access ociperlimab in its own trials over the option period and the initial transfer of know-how were not distinct from each other, as the right to access ociperlimab has limited value without the corresponding know-how transfer, and therefore should be combined into one distinct performance obligation.

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The Company determined the transaction price at the outset of the arrangement as the upfront payment of $ 300,000 .

The option exercise fee is contingent upon Novartis exercising its right and is considered fully constrained until the option is exercised.

Additionally, the milestone and royalty payments are not applicable until after the option is exercised, at which point the likelihood of meeting milestones, regulatory approval and meeting certain sales thresholds will be assessed.

The option exercise fee was contingent upon Novartis exercising its right and was considered fully constrained until the option was exercised.

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 would be assessed.

The transaction price was allocated to the three identified performance obligations based on a relative fair value basis.

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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 ociperlimab R&D Services.

The Company will satisfy the material right performance obligation at a point in time at the earlier of when Novartis exercises the option and the license is delivered or the expiration of the option period.

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.

The portion of the transaction price allocated to Novartis' right to access ociperlimab in its own clinical trials during the option period and the initial transfer of BeiGene know-how was deferred and is being recognized over the expected option period.

The portion of the transaction price allocated to the ociperlimab R&D Services was deferred and is being recognized as collaboration revenue as the ociperlimab R&D Services are performed over the expected option period.

The Company recognized collaboration revenue of $ 26,248 and $ 52,497 related to Novartis right to access ociperlimab in clinical trials and the transfer of know how performance obligation during the three and six months ended June 30, 2023, respectively, and $ 26,248 and $ 52,497 during the three and six months ended June 30, 2022, respectively.

The Company recognized R&D service revenue of $ 1,792 and $ 3,583 during the three and six months ended June 30, 2023 and $ 1,792 and $ 3,584 during the three and six months ended June 30, 2022, respectively.

The Company also recognized other collaboration revenue of $ 1,861 and $ 2,636 related primarily to revenue generated under the broad markets marketing and promotion agreement in conjunction with the collaboration during the three and six months ended June 30, 2023, respectively.

In July 2023, the Company entered into a Mutual Termination and Release Agreement (the "Termination Agreement") to mutually terminate the ociperlimab option, collaboration and license agreement with Novartis, effective immediately.

The portion of the transaction price allocated to the ociperlimab R&D Services was deferred and was recognized as collaboration revenue as the ociperlimab R&D Services were performed over the expected option period.

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

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

In-Licensing Arrangements

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 Company recognized collaboration revenue of $ 51,978 and $ 104,475 related to Novartis’ right to access ociperlimab in clinical trials and the transfer of know how performance obligation during the three and nine months ended September 30, 2023, respectively, and $ 26,249 and $ 78,746 during the three and nine months ended September 30, 2022, respectively.

The Company recognized R&D service revenue of $ 3,569 and $ 7,153 during the three and nine months ended September 30, 2023 and $ 1,791 and $ 5,375 during the three and nine months ended September 30, 2022, respectively.

The Company recognized the $ 71,980 allocated to the material right as collaboration revenue upon termination during the quarter ended September 30, 2023.

The Company also recognized other collaboration revenue of $ 2,954 and $ 5,590 related to revenue generated under the broad

markets marketing and promotion agreement in conjunction with the collaboration during the three and nine months ended September 30, 2023, respectively.

In-Licensing Arrangements - Commercial

In October 2019, the Company entered into a global strategic oncology collaboration with Amgen (“Amgen Collaboration Agreement”) for the commercialization and development in China, excluding Hong Kong, Taiwan and Macau, of Amgen’s XGEVA ® , KYPROLIS ® and BLINCYTO ® , and the joint global development of a portfolio of oncology assets in Amgen’s pipeline, with BeiGene responsible for development and commercialization in China.

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In July 2020, the Company began commercializing XGEVA in China.

December 2020, BLINCYTO was approved in China for injection for the treatment of adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL).

In December 2020, BLINCYTO was approved in China for injection for the treatment of adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL).

In July 2021, KYPROLIS was conditionally approved in China for injection in combination with dexamethasone for the treatment of adult patients with R/R multiple myeloma.

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Per the SPA, the cash proceeds shall be used as necessary to fund the Company's development obligations under the Amgen Collaboration Agreement.

Pursuant to the SPA, Amgen also received the right to designate one member of the Company's board of directors, and Anthony Hooper joined the Company's board of directors as the Amgen designee in January 2020.

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.

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The cost share liability is being amortized proportionately as the Company contributes cash and development services to its total co-development funding cap.

Amounts recorded related to the Company's portion of the co-development funding on the pipeline assets for the three and six months ended June 30, 2023 and 2022 were as follows:

Three Months Ended Six Months Ended

June 30, June 30,

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, 2023 and 2022 were as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

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Total amount due to Amgen for BeiGene's portion of the development funding 32,221 50,268 78,164 142,640

September 30,

Remaining portion of development funding cap 517,544

As of June 30, 2023 and December 31, 2022, the research and development cost share liability recorded in the Company's balance sheet was as follows:

June 30, December 31,

As of September 30, 2023 and December 31, 2022, the research and development cost share liability recorded in the Company's balance sheet was as follows:

September 30, December 31,

Research and development cost share liability, current portion 63,652 114,335

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Total research and development cost share liability 255,391 293,960

The total reimbursement due to (from) Amgen under the commercial profit-sharing agreement for product sales is classified in the income statement for the three and six months ended June 30, 2023 and 2022 as follows:

Three Months Ended Six Months Ended

June 30, June 30,

The total reimbursement due to (from) Amgen under the commercial profit-sharing agreement for product sales is classified in the income statement for the three and nine months ended September 30, 2023 and 2022 as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

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

Inventory purchases amounted to $ 20,146 and $ 39,277 during the three and six months ended June 30, 2023, respectively, and $ 22,462 and $ 30,061 during the three and six months ended June 30, 2022, respectively.

Net amounts receivable from Amgen as of June 30, 2023 was $ 11,069 and net amounts payable to Amgen as of December 31, 2022 was $ 54,064 , respectively.

Inventory purchases amounted to $ 18,746 and $ 58,023 during the three and nine months ended September 30, 2023, respectively, and $ 29,269 and $ 59,330 during the three and nine months ended September 30, 2022, respectively.

Net amounts payable to Amgen was $ 45,918 and $ 54,064 as of September 30, 2023 and December 31, 2022, respectively.

In-Licensing Arrangements - Development

The Company has in-licensed the rights to develop, manufacture and, if approved, commercialize multiple development stage drug candidates globally or in specific territories.

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

Upfront and milestone payments made under these arrangements for the three and nine months ended September 30, 2023 and 2022 are set forth below.

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

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

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

Payments due to collaboration partners Classification $ $ $ $

Upfront payments Research and development expense 15,000 20,000 15,000 20,000

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

Total 24,379 20,000 33,612 20,000

Restricted Cash and Investments

Restricted Cash

The Company’s restricted cash balance of $ 11,206 and $ 5,473 as of June 30, 2023 and December 31, 2022, respectively, 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 for 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, 2023 and December 31, 2022 was as follows:

September 30, December 31,

Short-term restricted cash 11,548 196

Long-term restricted cash 2,008 5,277

Total 13,556 5,473

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.

As of September 30, 2023, the Company had cash remaining related to the STAR Offering proceeds of $ 1,349,492 .

Short-Term Investments

Short-term investments as of June 30, 2023 consisted of the following available-for-sale debt securities:

Short-term investments as of September 30, 2023 consisted of the following available-for-sale debt securities:

Gross Gross Fair Value

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Total 674,262 — 9,011 665,251

As of June 30, 2023, the Company's available-for-sale debt securities consisted entirely of short-term U.S.

As of September 30, 2023, the Company's available-for-sale debt securities consisted entirely of short-term U.S.

treasury securities, which were determined to have zero risk of expected credit loss.

Accordingly, no allowance for credit loss was recorded as of June 30, 2023.

Accordingly, no allowance for credit loss was recorded as of September 30, 2023.

Equity Securities with Readily Determinable Fair Values

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In September 2021, the Company purchased $ 7,250 of common stock in Leap's underwritten public offering.

As of June 30, 2023, the Company's ownership interest in the outstanding common stock of Leap was 6.2 % based on information from Leap.

Inclusive of the shares of common stock issuable upon the exercise of the currently exercisable warrants, the Company's interest is approximately 9.8 % based on information from 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.

The Company recorded an unrealized gain of $ 470 and unrealized loss of $ 636 for the three and six months ended June 30, 2023, respectively, and unrealized losses of $ 5,908 and $ 22,661 for the three and six months ended June 30, 2022, respectively, in the consolidated statements of operations.

As of June 30, 2023 and December 31, 2022, the fair value of the common stock and warrants were as follows:

June 30, December 31,

As of September 30, 2023, the Company's ownership interest in the outstanding common stock of Leap was 2.9 % based on information from Leap.

Inclusive of the shares of common stock issuable upon the exercise of the currently exercisable warrants, the Company's interest is approximately 4.7 %.

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.

Losses recognized on the Company's investment in Leap were as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

Other income (expense), net

( 2,291 ) ( 2,950 ) ( 2,927 ) ( 25,611 )

As of September 30, 2023 and December 31, 2022, the fair value of the common stock and warrants were as follows:

September 30, December 31,

Fair value of Leap common stock 1,014 3,307

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These investments are recorded at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.

The Company held investments of $ 59,209 and $ 57,054 in equity securities without readily determinable fair values as of June 30, 2023 and December 31, 2022, respectively.

The Company recorded no gain during the three months ended and a gain of $ 1,081 for the six months ended June 30, 2023, respectively, and a gain of $ 366 for the three and six months ended June 30, 2022, respectively, related to observable price changes in orderly transactions for similar investments of the same issuer to other income, net in the consolidated statements of operations.

The Company held investments of $ 57,631 and $ 57,054 in equity securities without readily determinable fair values as of September 30, 2023 and December 31, 2022, respectively.

Gains/losses recognized on the Company's investments in equity securities without readily determinable fair values were as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

Other income (expense), net

( 5,522 ) 4,699 ( 4,441 ) 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 investee's income and expenses, as well as dividends, if any.

The Company holds equity-method investments totaling $ 30,020 and $ 27,710 as of June 30, 2023 and December 31, 2022, respectively, that it does not consider to be individually significant to its financial statements.

The Company recorded net unrealized losses of $ 2,480 and $ 2,624 for the three and six months ended June 30, 2023, respectively, and net unrealized losses of $ 647 and $ 1,234 for the three and six months ended June 30, 2022, respectively, to other income, net in the consolidated statements of operations.

The Company’s inventory balance consisted of the following:

June 30, December 31,

The Company holds equity-method investments totaling $ 27,325 and $ 27,710 as of September 30, 2023 and December 31, 2022, respectively, that it does not consider to be individually significant to its financial statements.

Losses recognized on the Company's equity-method investments were as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

Other income (expense), net

( 2,675 ) ( 1,357 ) ( 5,299 ) ( 2,591 )

Inventories, Net

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

September 30, December 31,

Raw materials 94,031 88,957

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Finished goods 182,875 172,503

Total inventories 321,333 282,346

Total inventories, net 316,929 282,346

Property, Plant and Equipment, Net

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

June 30, December 31,

September 30, December 31,

Land 65,485 65,485

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Property, plant and equipment, net 1,178,038 845,946

In November 2021, the Company purchased a 42 -acre site located in Hopewell, NJ for $ 75,197 .

The total purchase price was allocated between the land and an existing building on the property based on their relative fair values.

The Company is constructing a biologics manufacturing facility and research and development center on the land.

As of June 30, 2023, the Company has construction in process of $ 314,707 related to the Hopewell facility construction.

Depreciation expense was $ 21,307 and $ 40,332 for the three and six months ended June 30, 2023, respectively, and $ 14,461 and $ 30,041 for the three and six months ended June 30, 2022, respectively.

As of September 30, 2023, the Company has construction in process of $ 419,498 related to the Hopewell facility construction.

Depreciation expense was $ 19,242 and $ 59,574 for the three and nine months ended September 30, 2023, respectively, and $ 15,214 and $ 45,255 for the three and nine months ended September 30, 2022, respectively.

Intangible Assets

Intangible assets as of June 30, 2023 and December 31, 2022 are summarized as follows:

June 30, 2023 December 31, 2022

Intangible assets as of September 30, 2023 and December 31, 2022 are summarized as follows:

September 30, 2023 December 31, 2022

carrying Accumulated Intangible carrying Accumulated Intangible

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Product distribution rights consist of distribution rights on the approved cancer therapies licensed from Bristol-Myers Squibb Company (“BMS”) as part of the BMS collaboration.

The Company is amortizing the product distribution rights, as a single identified asset, over a period of 10 years from the date of acquisition.

The Company is amortizing the product distribution rights, as a single identified asset, through December 31, 2023, when the rights revert back to BMS under the terms of the Settlement Agreement.

Developed products represent the post-approval milestone payments under license and commercialization agreements.

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Amortization expense was as follows:

Three Months Ended Six Months Ended

June 30, June 30,

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

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Total 2,268 987 4,282 3,007

Estimated amortization expense for each of the five succeeding years and thereafter, as of June 30, 2023 is as follows:

Estimated amortization expense for each of the five succeeding years and thereafter, as of September 30, 2023 is as follows:

Year Ending December 31, Cost of Sales - Product Operating Expenses Total

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Total 51,820 1,837 53,657

Income tax expense was $ 13,674 and $ 25,166 for the three and six months ended June 30, 2023, respectively.

Income tax expense was $ 8,141 and $ 22,090 for the three and six months ended June 30, 2022.

The income tax expense for the three and

six months ended June 30, 2023 and 2022 was primarily attributable to current China tax expense due to certain non-deductible expenses and current U.S.

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

Income tax expense was $ 6,318 and $ 28,408 for the three and nine months ended September 30, 2022.

The income tax expense for the three and nine months ended September 30, 2023 and 2022 was primarily attributable to current China tax expense due to certain non-deductible expenses and current U.S.

tax expense determined after other special tax deductions and research and development tax credits.

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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 June 30, 2023, the Company will maintain a full valuation allowance against its net deferred tax assets.

As of June 30, 2023, the Company had gross unrecognized tax benefits of $ 12,524 .

After consideration of all positive and negative evidence, as of September 30, 2023, the Company will maintain a full valuation allowance against its net deferred tax assets.

As of September 30, 2023, the Company had gross unrecognized tax benefits of $ 13,910 .

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 $ 559 and $ 969 in the three and six months ended June 30, 2023 primarily due to U.S.

The Company’s reserve for uncertain tax positions increased by $ 1,386 and $ 2,355 in the three and nine months ended September 30, 2023 primarily due to U.S.

federal and state tax credits and incentives.

The Company has elected to record interest and penalties related to income taxes as a component of income tax expense.

As of June 30, 2023 and December 31, 2022, the Company's accrued interest and penalties, where applicable, related to uncertain tax positions were not material.

The Company conducts business in a number of tax jurisdictions and, as such, is required to file income tax returns in multiple jurisdictions globally.

As of June 30, 2023, Australia tax matters are open to examination for the years 2013 through 2023, China tax matters are open to examination for the years 2013 through 2023, Switzerland tax matters are open to examination for the years 2018 through 2023, and U.S.

As of September 30, 2023, Australia tax matters are open to examination for the years 2013 through 2023, China tax matters are open to examination for the years 2013 through 2023, Switzerland tax matters are open to examination for the years 2018 through 2023, and U.S.

federal tax matters are open to examination for years 2015 through 2023.

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Prepaid expenses and other current assets consist of the following:

June 30, December 31,

September 30, December 31,

Prepaid research and development costs 73,036 71,488

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Other receivables 43,911 22,777

Prepaid commercial 1,089 1,461

Interest receivable 1,628 3,039

Prepaid insurance 6,492 3,664

Short-term deposit for sales rebates 7,198 1,510

Other current assets 23,944 34,696

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Other non-current assets consist of the following:

June 30, December 31,

Goodwill 109 109

September 30, December 31,

Prepayment of property and equipment 12,343 22,025

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Rental deposits and other 6,944 7,054

Long-term restricted cash 2,008 5,277

Long-term investments 89,281 91,779

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Accrued expenses and other payables consist of the following:

June 30, December 31,

September 30, December 31,

Compensation related 173,980 184,775

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Other long-term liabilities consist of the following:

June 30, December 31,

September 30, December 31,

Deferred government grant income 33,909 38,176

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Total 41,986 46,095

The following table summarizes the Company's short-term and long-term debt obligations as of June 30, 2023 and December 31, 2022:

The following table summarizes the Company's short-term and long-term debt obligations as of September 30, 2023 and December 31, 2022:

Lender Agreement Date Line of Credit Term Maturity Date Interest Rate As of

June 30, 2023 December 31, 2022

September 30, 2023 December 31, 2022

China Construction Bank April 4, 2018 RMB 580,000 9 -year

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

The loan interest rate was 4.5 % as of June 30, 2023.

The loan interest rate was 4.5 % as of September 30, 2023.

The loan is secured by BeiGene Guangzhou Factory's land use right and certain Guangzhou Factory fixed assets in the first phase of the Guangzhou manufacturing facility's build out.

The Company repaid $ 3,483 (RMB 25,000 ) during the six months ended June 30, 2023.

The Company repaid $ 3,483 (RMB 25,000 ) during the nine months ended September 30, 2023.

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.

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In connection with the Company's short-term loan agreements with China Merchants Bank entered into during the year ended December 31, 2020, the borrowing capacity was reduced from RMB 1,100,000 to RMB 350,000 .

The loan interest rate was 4.1 % as of June 30, 2023.

The Company repaid $ 731 (RMB 5,000 ) during the six months ended June 30, 2023.

BeiGene Guangzhou Biologics Manufacturing Co., Ltd.

is a company incorporated under the laws of the PRC on March 3, 2017 and a wholly owned subsidiary of BeiGene Biologics.

The loan interest rate was 4.1 % as of September 30, 2023.

The Company repaid $ 1,081 (RMB 7,500 ) during the nine months ended September 30, 2023.

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

The loan interest rate was 4.0% as of June 30, 2023.

The loan interest rate was 3.9 % as of September 30, 2023.

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 $ 2,518 (RMB 17,500 ) during the six months ended June 30, 2023.

The Company repaid $ 3,898 (RMB 27,500 ) during the nine months ended September 30, 2023.

In September 2020, the Company entered into a loan agreement with China Minsheng Bank for a total loan facility of up to $ 200,000 (“Senior Loan”), of which $ 120,000 was designated to fund the purchase of noncontrolling equity interest in BeiGene Biologics Co., Ltd.

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On September 30, 2022, the Company entered into an amendment and restatement agreement with China Minsheng Bank to extend the maturity date to October 9, 2023.

BeiGene Biologics Co., Ltd.

is a company incorporated under the laws of the PRC on January 25, 2017 and an indirectly wholly owned subsidiary of the Company.

During the years ended December 31, 2022 and 2021, 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, with maturity dates ranging from December 15, 2022 to September 18, 2023.

The Company repaid $ 16,574 (RMB 117,000 ) and drew down $ 28,174 (RMB 199,000 ) during the six months ended June 30, 2023.The weighted average interest rate for the short-term working capital loans was approximately 2.6 % as of June 30, 2023.

In October 2023, the Company repaid the outstanding principal of the Senior Loan in the amount of $ 150,000 .

The Company repaid $ 109,576 (RMB 792,000 ) and drew down $ 28,174 (RMB 199,000 ) during the nine months ended September 30, 2023.The weighted average interest rate for the short-term working capital loans was approximately 3.2 % as of September 30, 2023.

The outstanding principal balance is due in May 2024.

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 $ 22,502 (RMB 163,000 ) during the six months ended June 30, 2023.

The weighted average loan interest rate was 4.1 % as of June 30, 2023.

The loan is secured by BeiGene Suzhou Co., Ltd.'s land use right.

The Company drew down $ 22,502 (RMB 163,000 ) during the nine months ended September 30, 2023.

The weighted average loan interest rate was 3.9 % as of September 30, 2023.

The loan is secured by BeiGene Suzhou Co., Ltd.'s land use right and construction in process.

Line of Credit

On July 28, 2023 (the “Signing Date”), a credit facility agreement (the “Credit Agreement”) was entered into by and between the Company, as the borrower, and China Merchants Bank Co., Ltd., as the lender (the “Lender”).

The Credit Agreement provides for a $ 400 million uncommitted and unsecured credit facility (the “Credit Facility”), pursuant to which each loan issued has a term up to one year , provided that all loans must be repaid within eighteen months of the Signing Date.

Loans under the Credit Facility have a floating interest rate based on the secured overnight financing rate plus an applicable margin and are calculated daily from the date the loan is utilized and settled on a quarterly basis.

As of September 30, 2023, no borrowings were outstanding under the Credit Agreement.

Interest Expense

Interest expense recognized for the three and six months ended June 30, 2023 was $ 4,891 and $ 9,465 , respectively, among which, $ 428 and $ 772 was capitalized, respectively.

Interest expense recognized for the three and six months ended June 30, 2022 was $ 5,456 and $ 10,984 , respectively, among which, $ 654 and $ 1,935 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 and nine months ended September 30, 2022 was $ 5,596 and $ 16,580 , respectively, among which, $ 527 and $ 2,462 was capitalized, respectively.

Product Revenue

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

The table below presents the Company’s net product sales for the three and six months ended June 30, 2023 and 2022.

Three Months Ended Six Months Ended

June 30, June 30,

The table below presents the Company’s net product sales for the three and nine months ended September 30, 2023 and 2022.

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

2 unchanged sentences

Product revenue – net 595,290 349,506 1,559,326 915,590

The following table disaggregates net product sales by product for the three and six months ended June 30, 2023 and 2022:

Three Months Ended Six Months Ended

June 30, June 30,

The following table disaggregates net product sales by product for the three and nine months ended September 30, 2023 and 2022:

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

10 unchanged sentences

Total product revenue – net 595,290 349,506 1,559,326 915,590

The following table presents the roll-forward of accrued sales rebates and returns for the six months ended June 30, 2023 and 2022:

Six Months Ended

The following table presents the roll-forward of accrued sales rebates and returns for the nine months ended September 30, 2023 and 2022:

Nine Months Ended

September 30,

Balance at beginning of the period 41,817 59,639

2 unchanged sentences

Balance at end of the period 112,256 49,890

Loss Per Share

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

Three Months Ended Six Months Ended

June 30, June 30,

Earnings (Loss) Per Share

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

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

Net loss ( 381,137 ) ( 565,726 ) ( 729,568 ) ( 1,000,924 )

Weighted average shares outstanding—basic and diluted 1,360,224,377 1,336,463,026 1,357,211,308 1,334,252,648

For the three and six months ended June 30, 2023 and 2022, 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.

Net income (loss) 215,413 ( 557,556 ) ( 514,155 ) ( 1,558,480 )

Weighted average shares outstanding—basic 1,360,716,279 1,345,303,747 1,358,392,470 1,337,976,853

Effect of dilutive securities:

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

Weighted average shares outstanding—diluted 1,390,331,833 1,345,303,747 1,358,392,470 1,337,976,853

Basic earnings per share was computed using the weighted-average number of ordinary shares outstanding during the period.

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.

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.

For the nine months ended September 30, 2023 and the three and nine months ended September 30, 2022, 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.

Share-Based Compensation Expense

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The Company initially reserved 65,029,595 ordinary shares for the issuance of awards under the 2016 Plan, plus any shares available under the 2011 Option Plan (the “2011 Plan”), and not subject to any outstanding options as of the effective date of the 2016 Plan, along with underlying share awards under the 2011 Plan that are cancelled or forfeited without issuance of ordinary shares.

As of June 30, 2023, ordinary shares cancelled or forfeited under the 2011 Plan that were carried over to the 2016 Plan totaled 5,166,822 .

As of September 30, 2023, ordinary shares cancelled or forfeited under the 2011 Plan that were carried over to the 2016 Plan totaled 5,166,822 .

In December 2018, the shareholders approved an amended and restated 2016 Plan to increase the number of shares authorized for issuance by 38,553,159 ordinary shares, as well as amend the cap on annual compensation to independent directors and make other changes.

2 unchanged sentences

The number of shares available for issuance under the 2016 Plan is subject to adjustment in the event of a share split, share dividend or other change in the Company’s capitalization.

During the six months ended June 30, 2023, the Company granted options for 9,396,660 ordinary shares and restricted share units for 29,453,021 ordinary shares under the 2016 Plan.

As of June 30, 2023, options and restricted share units for ordinary shares outstanding under the 2016 Plan totaled 64,070,175 and 68,073,668 , respectively.

As of June 30, 2023, share-based awards to acquire 38,873,106 ordinary shares were available for future grant under the 2016 Plan.

During the nine months ended September 30, 2023, the Company granted options for 9,710,389 ordinary shares and restricted share units for 32,773,429 ordinary shares under the 2016 Plan.

As of September 30, 2023, options and restricted share units for ordinary shares outstanding under the 2016 Plan totaled 62,526,923 and 67,329,574 , respectively.

As of September 30, 2023, share-based awards to acquire 37,482,015 ordinary shares were available for future grant under the 2016 Plan.

In order to continue to provide incentive opportunities under the 2016 Plan, the Board of Directors and shareholders of the Company approved an amendment to the 2016 Plan (the “Amendment No.

5 unchanged sentences

In August 2018, in connection with the Hong Kong IPO, the board of directors of the Company approved an amended and restated 2018 Plan to implement changes required by the listing rules of the Stock Exchange of Hong Kong Limited (“HKEX”).

As of June 30, 2023, there were no options or restricted share units for ordinary shares outstanding under the 2018 Plan.

As of September 30, 2023, there were no options or restricted share units for ordinary shares outstanding under the 2018 Plan.

Upon the effectiveness of Amendment No.

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

As of June 30, 2023, 2,735,219 ordinary shares were available for future issuance under the ESPP.

As of September 30, 2023, 1,941,075 ordinary shares were available for future issuance under the ESPP.

The following tables summarizes the shares issued under the ESPP:

2 unchanged sentences

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

August 31, 2023 794,144 $ 207.55 $ 15.97 $ 176.42 $ 13.57 $ 10,777

February 28, 2023 930,582 $ 171.10 $ 13.16 $ 145.44 $ 11.19 $ 10,414

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2 The purchase price is the price which was discounted from the applicable market price, in accordance with the terms of the ESPP.

The following table summarizes total share-based compensation expense recognized for the three and six months ended June 30, 2023 and 2022:

Three Months Ended Six Months Ended

June 30, June 30,

The following table summarizes total share-based compensation expense recognized for the three and nine months ended September 30, 2023 and 2022:

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

10 unchanged sentences

Net-current period other comprehensive (loss) income ( 75,732 ) 8,218 — ( 67,514 )

Balance as of June 30, 2023 ( 135,695 ) ( 2,109 ) ( 5,883 ) ( 143,687 )

Balance as of September 30, 2023 ( 138,255 ) ( 793 ) ( 5,883 ) ( 144,931 )

Shareholders’ Equity

Share Purchase Agreement

In September 2021, the Company issued an aggregate of 165,529 ADSs, representing 2,151,877 ordinary shares, to Amgen for a total consideration of $ 50,000 , in a private placement pursuant to a Share Purchase Agreement dated October 31, 2019, as amended on December 6, 2019, September 24, 2020 and January 30, 2023 by and between Amgen and Company.

STAR Offering

In December 2021, the Company completed an initial public offering of (“STAR Offering”) on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange (“SSE”).

The shares offered in the STAR Offering were issued to and subscribed for by permitted investors in the People’s Republic of China (“PRC”) in Renminbi (“RMB Shares”).

The public offering price of the RMB Shares was RMB 192.60 per ordinary share, or $ 391.68 per ADS.

In this offering, the Company sold 115,055,260 ordinary shares.

Net proceeds after deducting underwriting discounts and commission and offering expenses were $ 3,392,616 .

As required by the PRC securities laws, the net proceeds from the STAR Offering must be used in strict compliance with the planned uses as disclosed in the PRC prospectus as well as the Company's proceeds management policy for the STAR Offering approved by the board of directors.

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 (expense), net in the consolidated statements of operations.

The shares were constructively retired as of September 30, 2023.

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

Restricted Net Assets

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A domestic enterprise is also required to provide discretionary surplus reserve, at the discretion of the board of directors, from the profits determined in accordance with the enterprise’s PRC statutory accounts.

The aforementioned reserves can only be used for specific purposes and are not distributable as cash dividends.

The aforementioned

reserves can only be used for specific purposes and are not distributable as cash dividends.

The Company’s PRC subsidiaries were established as domestic enterprises and therefore are subject to the above-mentioned restrictions on distributable profits.

1 unchanged sentence

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 June 30, 2023 and December 31, 2022, the net assets of the Company’s PRC subsidiaries amounted to $ 3,305,583 and $ 3,548,881 , respectively.

As of September 30, 2023 and December 31, 2022, the net assets of the Company’s PRC subsidiaries amounted to $ 3,825,964 and $ 3,548,881 , respectively.

Commitments and Contingencies

Purchase Commitments

As of June 30, 2023, the Company had purchase commitments amounting to $ 104,115 , of which $ 40,295 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $ 63,820 related to binding purchase obligations of inventory from BMS and Amgen.

As of September 30, 2023, the Company had non-cancellable purchase commitments amounting to $ 131,693 , of which $ 41,186 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $ 90,507 related to binding purchase obligations of inventory from BMS and Amgen.

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

Capital Commitments

The Company had capital commitments amounting to $ 381,187 for the acquisition of property, plant and equipment as of June 30, 2023, 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 new building for Beijing Innerway Bio-tech Co., Ltd.

The Company had capital commitments amounting to $ 442,562 for the acquisition of property, plant and equipment as of September 30, 2023, which were mainly for the Company’s Hopewell facility, additional capacity at the Guangzhou and Suzhou manufacturing facilities, and new building for Beijing Innerway Bio-tech Co., Ltd.

Co-Development Funding Commitment

1 unchanged sentence

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

As of June 30, 2023, the Company's remaining co-development funding commitment was $ 549,765 .

As of September 30, 2023, the Company's remaining co-development funding commitment was $ 517,544 .

Research and Development Commitment

The Company entered into a long-term research and development agreement in June 2021, which includes obligations to make an upfront payment and fixed quarterly payments over the next four years .

As of June 30, 2023, the total research and development commitment amounted to $ 17,990 .

The Company entered into a long-term research and development agreement in June 2021, which includes obligations to make an upfront payment and fixed quarterly payments over the next three years .

As of September 30, 2023, the total research and development commitment amounted to $ 16,498 .

Funding Commitment

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

As of June 30, 2023, the remaining capital commitment was $ 10,557 and is expected to be paid from time to time over the investment period.

Pension Commitment

The Company maintains a defined benefit pension plan in Switzerland.

Funding obligations under the defined benefit pension plan are equivalent to $ 2,627 per year based on annual funding contributions in effect as of June 30, 2023 to achieve fully funded status where the market value of plan assets equals the projected benefit obligations.

Future funding requirements will be subject to change as a result of future changes in staffing and compensation levels, various actuarial assumptions and actual investment returns on plan assets.

Other Business Agreements

The Company enters into agreements with contract research organizations (“CROs”) to some extent to provide research and development services.

These contracts are generally cancellable at any time by us with prior written notice.

The Company also enters into collaboration agreements with institutions and companies to license intellectual property.

The Company may be obligated to make future development, regulatory and commercial milestone payments and royalty payments on future sales of specified products associated with its collaboration agreements.

Payments under these agreements generally become due and payable upon achievement of such milestones or sales.

These commitments are not recorded on the Company's balance sheet because the achievement and timing of these milestones are not fixed and determinable.

When the achievement of these milestones or sales have occurred, the corresponding amounts are recognized in the Company’s financial statements.

Legal Proceedings

In the ordinary course of business, the Company may be subject to legal proceedings, claims and litigation as the Company operates in an industry susceptible to patent legal claims.

The Company accounts for estimated losses with respect to legal proceedings and claims when such losses are probable and estimable.

Legal costs associated with these matters are expensed when incurred.

As of September 30, 2023, the remaining capital commitment was $ 10,553 and is expected to be paid from time to time over the investment period.

Segment and Geographic Information

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Net product revenues by geographic area are based upon the location of the customer, and net collaboration revenue is recorded in the jurisdiction in which the related income is expected to be sourced from.

Total product revenues by geographic area are presented as follows:

Three Months Ended Six Months Ended

June 30, June 30,

2023 2022 2023 2022

PRC 293,919 212,429 540,828 403,164

United States 223,540 88,381 362,307 156,269

Rest of world 36,286 3,701 60,901 6,651

Total 553,745 304,511 964,036 566,084

Total collaboration revenues by geographic area are presented as follows:

Three Months Ended Six Months Ended

June 30, June 30,

Total revenues by geographic area are presented as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

PRC 1,861 — 2,636 —

United States 28,809 25,943 54,523 57,480

Rest of world 10,846 11,118 21,867 24,634

Total 41,516 37,061 79,026 82,114

Subsequent Events

The Credit Agreement provides for a $ 400 million uncommitted and unsecured credit facility (the “Credit Facility”), pursuant to which each loan issued has a term up to one year, provided that all loans must be repaid within eighteen months of the Signing Date.

The proceeds of the loans under the Credit Facility are available to finance the working capital needs and for daily operations of the Company and its subsidiaries.

The Credit Agreement contains financial covenants that require the Company to uphold certain ratios of liabilities to ownership equity, maintain specified amounts of both consolidated net assets and consolidated cash balance, and reach a certain amount of annual sales revenue for products, all which are tested either quarterly or annually.

The Credit Agreement also contains operating covenants including, among other things, (i) maintaining its listing status on The Stock Exchange of Hong Kong Limited and The Science and Technology Innovation Board of the Shanghai Stock Exchange, (ii) preserving interest reserve in the account with the Lender, (iii) limitations on the incurrence of certain additional indebtedness, and (iv) preservation of ownership of key patents and other covenants surrounding the Company’s intellectual property.

Other certain covenants, representations and warranties, and events of default, are contained in the Credit Agreement, many of which would be breached or triggered solely to the extent they have a material adverse effect on the Company’s ability to perform its obligations under the Credit Agreement or affect the Company’s normal operations.

As of the date of this report, no borrowings were outstanding under the Credit Agreement.

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.

The Company has no payment obligation in exchange for the transferred shares 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.

United States- total revenue 398,229 133,431 815,059 347,180

Product revenue 270,084 108,104 632,391 264,373

Collaboration revenue 128,145 25,327 182,668 82,807

China- total revenue 287,935 233,077 831,399 636,241

Product revenue 284,981 233,077 825,809 636,241

Collaboration revenue 2,954 — 5,590 —

Europe- total revenue 85,583 17,995 153,273 46,634

Product revenue 30,664 5,200 76,487 9,205

Collaboration revenue 54,919 12,795 76,786 37,429

Rest of world- product revenue 9,561 3,125 24,639 5,771

Total Revenue 781,308 387,628 1,824,370 1,035,826

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