What changed in this filing

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Item 1. Financial Statements

2024-05-08 compared with 2023-11-09 · 260 added, 444 removed, 437 unchanged (62% of the section changed)

1 unchanged sentence

BEIGENE, LTD.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Amounts in thousands of U.S.

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

Three Months Ended

Note 2024 2023

Product revenue, net 11 746,918 410,291

Collaboration revenue 3 4,734 37,510

Total revenues 751,652 447,801

Cost of sales - product 124,935 81,789

Gross profit 626,717 366,012

Operating expenses

Research and development 460,638 408,584

Selling, general and administrative 427,427 328,499

Amortization of intangible assets — 187

Total operating expenses 888,065 737,270

Loss from operations ( 261,348 ) ( 371,258 )

Interest income, net 16,160 16,016

Other income, net 1,762 18,303

Loss before income taxes ( 243,426 ) ( 336,939 )

Income tax expense 8 7,724 11,492

Net loss ( 251,150 ) ( 348,431 )

Net loss per share, basic and diluted 12 ( 0.19 ) ( 0.26 )

Weighted-average shares outstanding—basic and diluted 1,355,547,626 1,354,164,760

Net loss per American Depositary Share (“ADS”), basic and diluted 12 ( 2.41 ) ( 3.34 )

Weighted-average ADSs outstanding—basic and diluted 104,272,894 104,166,520

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

BEIGENE, LTD.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(Amounts in thousands of U.S.

Dollars (“$”))

Three Months Ended

Net loss ( 251,150 ) ( 348,431 )

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

Foreign currency translation adjustments ( 32,163 ) 13,347

Unrealized holding income (loss), net ( 35 ) 5,056

Comprehensive loss ( 283,348 ) ( 330,028 )

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

BEIGENE, LTD.

CONDENSED CONSOLIDATED BALANCE SHEETS

1 unchanged sentence

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

September 30, December 31,

March 31, December 31,

Note 2024 2023

2 unchanged sentences

Cash and cash equivalents 2,793,370 3,171,800

Short-term restricted cash 4 11,548 196

Short-term investments 4 — 2,600

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Accrued expenses and other payables 9 569,438 693,731

Deferred revenue, current portion 3 — 213,861

Tax payable 8 27,324 22,951

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Long-term bank loans 10 199,027 197,618

Deferred revenue, non-current portion 3 300 42,026

Operating lease liabilities, non-current portion 17,722 22,251

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Shareholders’ equity:

Ordinary shares, US$ 0.0001 par value per share;

Ordinary shares, $ 0.0001 par value per share;

9,500,000,000 shares authorized;

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

1,359,524,369 and 1,359,513,224 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively

Additional paid-in capital 11,705,069 11,598,688

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BEIGENE, LTD.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Amounts in thousands of U.S.

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

Three Months Ended Nine Months Ended

September 30, September 30,

Note 2023 2022 2023 2022

Product revenue, net 11 595,290 349,506 1,559,326 915,590

Collaboration revenue 3 186,018 38,122 265,044 120,236

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

Cost of sales - product 96,309 76,543 274,088 212,953

Research and development 453,259 426,363 1,284,607 1,194,485

Selling, general and administrative 364,421 322,892 1,087,954 948,868

Amortization of intangible assets 1,287 187 1,662 563

Total expenses 915,276 825,985 2,648,311 2,356,869

Loss from operations ( 133,968 ) ( 438,357 ) ( 823,941 ) ( 1,321,043 )

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

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 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 INCOME (LOSS)

(Amounts in thousands of U.S.

Dollars (“$”))

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

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

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

Foreign currency translation adjustments ( 2,559 ) ( 80,326 ) ( 75,732 ) ( 168,411 )

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

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.

BEIGENE, LTD.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

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Dollars (“$”))

Nine Months Ended September 30,

Three Months Ended March 31,

Note 2024 2023

4 unchanged sentences

Share-based compensation expenses 13 88,667 75,322

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

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

Gain on deconsolidation of a subsidiary ( 3,735 ) —

Amortization of research and development cost share liability 3 ( 13,136 ) ( 17,398 )

Deferred income tax benefits 735 380

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

Other items, net 848 780

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Purchase of intangible asset ( 4,674 ) —

Purchases of investments ( 15,581 ) ( 14,735 )

Proceeds from sale or maturity of investments 2,655 376,962

Purchase of in-process research and development ( 31,800 ) —

Net cash provided by investing activities 122,588 1,038,587

Other investing activities ( 19,434 ) ( 10,314 )

Net cash (used in) provided by investing activities ( 209,831 ) 241,063

Financing activities:

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Proceeds from option exercises and employee share purchase plan 14,791 31,589

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

Net cash provided by (used in) financing activities 162,293 ( 19,868 )

Effect of foreign exchange rate changes, net ( 22,438 ) 11,311

10 unchanged sentences

Capital expenditures included in accounts payable and accrued expenses 100,473 64,013

Acquired intangible asset included in accounts payable 9,384 —

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

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

12 unchanged sentences

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Net income — — — — 215,413 215,413

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

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

Balance at December 31, 2022 1,356,140,180 135 11,540,979 ( 77,417 ) ( 7,080,342 ) 4,383,355

Cost from issuance of ordinary shares — — ( 152 ) — — ( 152 )

Use of shares reserved for share option exercises ( 98,774 ) — — — — —

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Share-based compensation — — 75,322 — — 75,322

Other comprehensive loss — — — ( 496 ) — ( 496 )

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

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

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

Use of shares reserved for share option exercises 5,016,518 — — — — —

Exercise of options, ESPP and release of RSUs 9,817,938 1 7,091 — — 7,092

Share-based compensation — — 81,305 — — 81,305

Other comprehensive loss — — — ( 99,904 ) — ( 99,904 )

Net loss — — — — ( 565,726 ) ( 565,726 )

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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BeiGene, Ltd.

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

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

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

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

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

and 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;

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.

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

The Company has obtained approvals to market BRUKINSA in the United States (“U.S.”), the People’s Republic of China (“China” or the “PRC”), the European Union (“EU”), the United Kingdom (“UK”), Canada, Australia, and additional international markets;

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

and PARTRUVIX in China.

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

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

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

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

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

The Company is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe.

The Company has conducted more than 120 clinical trials in-house, with over 21,000 subjects enrolled in approximately 45 regions.

This includes more than 36 pivotal or potentially registration-enabling trials across its portfolio, including three internally discovered, approved medicines.

Recognizing the importance of clinical trial activities in its industry and the challenges associated with outsourcing to third-party contract research organizations (“CROs”), the Company has built its own 3,000 + person internal clinical team and is largely CRO-free.

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 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.

The Company is building a commercial-stage biologics manufacturing and clinical R&D center at the Princeton West Innovation Park in Hopewell, New Jersey (the “Hopewell facility”), in addition to its existing state-of-the-art biologic and small molecule manufacturing facilities in China to support current and potential future demand of its medicines.

The Company also works with high quality contract manufacturing organizations (“CMOs”) to manufacture its internally developed clinical and commercial products.

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 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 condensed consolidated balance sheet as of March 31, 2024, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023, the condensed consolidated statements of cash flows for the three months ended March 31, 2024 and 2023, and the condensed consolidated statements of shareholders’ equity for the three months ended March 31, 2024 and 2023, 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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These financial statements should be read in conjunction with the consolidated financial statements and related footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 (the “Annual Report”).

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 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 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 months ended March 31, 2024 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.

Recent accounting pronouncements

New accounting standards which have not yet been adopted

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

Improvements to Reportable Segment Disclosures.

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

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

Early adoption is permitted.

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

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

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

Improvements to Income Tax Disclosures.

This update requires that public entities on an annual basis, (1) in the rate reconciliation, disclose specific categories and provide additional information for reconciling items that meet a quantitative threshold;

(2) about income taxes paid, disclose the amount of income taxes paid (net of refunds received) disaggregated by federal, state, and foreign taxes and by individual jurisdiction in which income taxes paid (net of refunds received) is equal to or greater than 5 percent of total income taxes paid (net of refunds received);

and (3) disclose income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign and income tax expense (or benefit) disaggregated by federal, state, and foreign.

This update is effective for annual periods beginning after December 15, 2024.

Early adoption is permitted.

This guidance should be applied on a prospective basis.

Retrospective application is permitted.

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

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, 2023.

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.

There have been no material changes to the Company’s significant accounting policies as of and for the three months ended March 31, 2024, 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 September 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 March 31, 2024 and December 31, 2023:

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

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

As of March 31, 2024 (Level 1) (Level 2) (Level 3)

Cash equivalents

1 unchanged sentence

Time deposits 42,861 — —

Short-term investments (Note 4):

Treasury securities 106,989 — —

Prepaid expenses and other current assets:

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Money market funds 1,052,149 — —

Time deposits 42,852 — —

Short-term investments (Note 4):

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

(“Leap”), which were acquired in connection with a collaboration and license agreement entered into in January 2020 and in Leap's underwritten public offering in September 2021.

The common stock investment in Leap, a publicly-traded biotechnology company, is measured and carried at fair value and classified as Level 1.

The warrants to purchase additional shares of common stock in Leap are classified as a Level 2 investment and are measured using the Black-Scholes option-pricing valuation model, which utilizes a constant maturity risk-free rate and reflects the term of the warrants, dividend yield and stock price volatility, that is based on the historical volatility of similar companies.

(“Leap”), a publicly-traded biotechnology company.

The common stock investment is measured and carried at fair value and classified as a Level 1 investment.

The warrants to purchase additional shares of common stock are measured using the Black-Scholes option-pricing valuation model and classified as a Level 2 investment.

Refer to Note 4, Restricted Cash and Investments for details of the determination of the carrying amount of private equity investments without readily determinable fair values and equity method investments.

The Company holds convertible notes issued by two private biotech companies.

The Company holds convertible notes issued by private biotech companies.

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

Accordingly, the convertible notes are remeasured at fair value on a recurring basis using Level 3 inputs, 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.

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.

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

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

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

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

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

Securities and Exchange Commission on February 26, 2024.

Out-Licensing Arrangements

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

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

For the three months ended March 31, 2023, the Company’s collaboration revenue primarily consisted of the recognition of previously deferred revenue from its former collaboration agreements with Novartis for tislelizumab and ociperlimab.

The following table summarizes total collaboration revenue recognized for the three months ended March 31, 2024 and 2023:

Three Months Ended

Revenue from Collaborators $ $

1 unchanged sentence

Right to access intellectual property revenue — 26,249

Material rights revenue 71,980 — 71,980 —

Other 4,734 4,444

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Tislelizumab Collaboration and License

In January 2021, the Company entered into a collaboration and license agreement with Novartis, granting Novartis rights to develop, manufacture and commercialize tislelizumab in 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 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.

The Company identified the following material components under the agreement:

(1) exclusive license for Novartis to develop, manufacture, and commercialize tislelizumab in the Novartis Territory, transfer of know-how and use of the tislelizumab trademark;

(2) conducting and completing ongoing trials of tislelizumab (“tislelizumab R&D services”);

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

The Company determined that the license, transfer of know-how and use of trademarks 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.

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 agreement.

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 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.

The standalone selling price of the license, transfer of know-how and use of trademarks performance obligation was determined using the adjusted market assessment approach.

Based on the valuation performed by the Company, the standalone selling price of the license, transfer of know-how and use of trademarks was valued at $ 1,231,000 .

The standalone selling price of the tislelizumab R&D services was valued at $ 420,000 using a cost plus margin valuation approach.

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 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.

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

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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.

No collaboration revenue was recognized in connection with the tislelizumab collaboration and license agreement during the three months ended March 31, 2024 due to termination of the agreement in 2023.

The following table summarizes collaboration revenue recognized for the three months ended March 31, 2023:

Three Months Ended

Research and development service revenue — 5,025

Total — 8,489

(1) Represents revenue recognized on sale of tislelizumab clinical supply to Novartis in conjunction with the collaboration.

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

In December 2021, the Company expanded its collaboration with Novartis by entering into an option, collaboration and license agreement with Novartis to develop, manufacture and commercialize the Company's investigational TIGIT inhibitor ociperlimab in the Novartis Territory.

In addition, the Company and Novartis entered into an agreement granting the Company rights to market, promote and detail five approved Novartis oncology products, TAFINLAR ® (dabrafenib), MEKINIST ® (trametinib), VOTRIENT ® (pazopanib), AFINITOR ® (everolimus), and ZYKADIA ® (ceritinib), across designated regions of China referred to as “broad markets.” In the first quarter of 2022, the Company initiated marketing and promotion of these five products.

Under the terms of the option, collaboration and license agreement, the Company received an upfront cash payment of $ 300,000 in January 2022 from Novartis and 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 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.

The Company identified the following material promises under the agreement:

(1) exclusive option for Novartis to license the rights to develop, manufacture, and commercialize ociperlimab in the Novartis Territory;

(2) Novartis' right to access ociperlimab in its own clinical trials during the option period;

(3) initial transfer of BeiGene know-how;

and (4) conducting and completing ongoing trials of ociperlimab during the option period (“ociperlimab R&D Services”, together with “tislelizumab R&D services”, “R&D services”).

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

The Company concluded that, at the inception of the agreement, the option for the exclusive product license 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.

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

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

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.

The standalone selling price of the material right for the option to the exclusive product license was calculated as the incremental discount between (i) the value of the license determined using a discounted cash flow method adjusted for probability of the option being exercised and (ii) the expected option exercise fee using the most-likely-amount method at option exercise.

The standalone selling price of the combined performance obligation for Novartis' right to access ociperlimab for its own clinical trials during the option period and the initial transfer of BeiGene know-how was determined using a discounted cash flow method.

The standalone selling price of the ociperlimab R&D Services was determined using an expected cost plus margin approach.

Based on the relative standalone selling prices of the three performance obligations, $ 71,980 of the total transaction price was allocated to the material right, $ 213,450 was allocated to Novartis' right to use ociperlimab in its own clinical trials during the option period and the transfer of BeiGene know-how, and $ 14,570 was allocated to the ociperlimab R&D Services.

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 was recognized over the expected option period.

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.

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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.

The following table summarizes collaboration revenue recognized in connection with the China broad markets agreement for the three months ended March 31, 2024 and the terminated ociperlimab option, collaboration and license agreement for the three months ended March 31, 2023:

Three Months Ended

Research and development service revenue — 1,792

Right to access intellectual property revenue — 26,249

China broad markets agreement 4,347 980

Total 4,347 29,021

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.

The agreement became effective on January 2, 2020, following approval by the Company's shareholders and satisfaction of other closing conditions.

Under the agreement, the Company is responsible for the commercialization of XGEVA, KYPROLIS and BLINCYTO in China for five or seven years .

Amgen is responsible for manufacturing the products globally and will supply the products to the Company at an agreed upon price.

The Company and Amgen will share equally in the China commercial profits and losses during the commercialization period.

Following the commercialization period, the Company has the right to retain one product and is entitled to receive royalties on sales in China for an additional five years on the products not retained.

XGEVA was approved in China in 2019 for patients with giant cell tumor of the bone and in November 2020 for the prevention of skeletal-related events in cancer patients with bone metastases.

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

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

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

In April 2022, BLINCYTO was conditionally approved for injection for the treatment of pediatric patients with R/R CD19-positive B-cell precursor ALL.

Amgen and the Company are also jointly developing a portfolio of Amgen oncology pipeline assets under the collaboration.

The Company is responsible for conducting clinical development activities in China and co-funding global development costs by contributing cash and development services up to a total cap of $ 1,250,000 .

Amgen is responsible for all development, regulatory and commercial activities outside of China.

For each pipeline asset that is approved in China, the Company will receive commercial rights for seven years from approval.

The Company has the right to retain approximately one out of every three approved pipeline assets, other than LUMAKRAS ® (sotorasib), Amgen's KRAS G12C inhibitor, for commercialization in China.

The Company and Amgen will share equally in the China commercial profits and losses during the commercialization period.

The Company is entitled to receive royalties from sales in China for pipeline assets returned to Amgen for five years after the seven-year commercialization period.

The Company is also entitled to receive royalties from global sales of each product outside of China (with the exception of LUMAKRAS).

On April 20, 2022, the parties entered into the First Amendment to Amgen Collaboration Agreement, which amends certain terms and conditions relating to the financial responsibilities of the parties in connections with the development and commercialization of certain Amgen proprietary products for the treatment of oncology-related diseases and conditions.

In connection with the Company’s ongoing assessment of the Amgen Collaboration Agreement cost-share contributions, the Company determined that further investment in the development of LUMAKRAS was no longer commercially viable for BeiGene.

As a result, in February 2023, the Company and Amgen entered into the Second Amendment to the Amgen Collaboration Agreement to (i) stop sharing costs with Amgen for the further development of LUMAKRAS during the period starting January 1, 2023 and ending August 31, 2023;

and (ii) cooperate in good faith to prepare a transition plan with the anticipated termination of LUMAKRAS from the Amgen Collaboration Agreement.

The Amgen Collaboration Agreement is within the scope of ASC 808, as both parties are active participants and are exposed to the risks and rewards dependent on the commercial success of the activities performed under the agreement.

The Company is the principal for product sales to customers in China during the commercialization period and recognizes 100 % of net product revenue on these sales.

Amounts due to Amgen for its portion of net product sales will be recorded as cost of sales.

Cost reimbursements due to or from Amgen under the profit share will be recognized as incurred and recorded to cost of sales;

selling, general and administrative expense;

or research and development expense, based on the underlying nature of the related activity subject to reimbursement.

Costs incurred for the Company's portion of the global co-development funding are recorded to research and development expense as incurred.

In connection with the Amgen Collaboration Agreement, a Share Purchase Agreement (“SPA”) was entered into by the parties in October 2019.

On January 2, 2020, the closing date of the transaction, Amgen purchased 15,895,001 of the Company's ADSs for $ 174.85 per ADS, representing a 20.5 % ownership stake in the Company.

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

Pursuant to the SPA, Amgen also received the right to designate one member of the Company's board of directors, and Anthony

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.

In determining the fair value of the common stock at closing, the Company considered the closing price of the common stock on the closing date of the transaction and included a lack of marketability discount because the shares are subject to certain restrictions.

The fair value of the shares on the closing date was determined to be $ 132.74 per ADS, or $ 2,109,902 in the aggregate.

The Company determined that the premium paid by Amgen on the share purchase represents a cost share liability due to the Company's co-development obligations.

The fair value of the cost share liability on the closing date was determined to be $ 601,857 based on the Company's discounted estimated future cash flows related to the pipeline assets.

The total cash proceeds of $ 2,779,241 were allocated based on the relative fair value method, with $ 2,162,407 recorded to equity and $ 616,834 recorded as a research and development cost share liability.

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

Amounts recorded related to the 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

During the three months ended March 31, 2024 and 2023, the Company recorded the following amounts related to its collaboration arrangement with Amgen.

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

Amounts recorded related to the Company’s portion of the co-development funding on the pipeline assets for the three months ended March 31, 2024 and 2023 were as follows:

Three Months Ended

Research and development expense 13,484 17,817

1 unchanged sentence

Total amount due to Amgen for BeiGene’s portion of the development funding 26,620 35,215

September 30,

Remaining portion of development funding cap 457,031

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,

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

March 31, December 31,

Research and development cost share liability, current portion 81,986 68,004

1 unchanged sentence

Total research and development cost share liability 225,530 238,666

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

The total reimbursement paid under the commercial profit-sharing agreement for product sales is classified in the income statement for the three months ended March 31, 2024 and 2023 as follows:

Three Months Ended

Cost of sales - product 8,569 ( 2,827 )

3 unchanged sentences

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

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.

Inventory purchases amounted to $ 62,226 and $ 19,131 during the three months ended March 31, 2024 and 2023, respectively.

Net amounts payable to Amgen was $ 93,561 and $ 55,474 as of March 31, 2024 and December 31, 2023, respectively.

In-Licensing Arrangements - Development

1 unchanged sentence

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.

Upfront and milestone payments incurred under these arrangements for the three months ended March 31, 2024 and 2023 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

Three Months Ended

Payments due to collaboration partners Classification $ $

Upfront payments Research and development expense 27 —

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

Development milestone payments Research and development expense 35,000 —

Total 35,027 —

3 unchanged sentences

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,

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

March 31, December 31,

Short-term restricted cash 11,445 11,473

1 unchanged sentence

Total 14,066 14,184

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 .

In addition to the restricted cash balances above, the Company is required by the PRC securities law to use the proceeds from our offering on the STAR Market of the Shanghai Stock Exchange (the “STAR Offering”) in strict compliance with the planned uses as disclosed in the PRC prospectus as well as those disclosed in the Company’s proceeds management policy approved by the board of directors.

As of March 31, 2024, the Company had cash remaining related to the STAR Offering proceeds of $ 960,961 .

Short-Term Investments

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

Gross Gross Fair Value

Amortized Unrealized Unrealized (Net Carrying

Cost Gains Losses Amount)

Treasury securities 107,783 — 794 106,989

Total 107,783 — 794 106,989

Short-term investments as of December 31, 2022 consisted of the following available-for-sale debt securities:

Gross Gross Fair Value

Amortized Unrealized Unrealized (Net Carrying

Cost Gains Losses Amount)

As of December 31, 2023, the Company’s short-term investments in available-for-sale debt securities consisted of U.S.

Treasury securities in the amount of $ 2,600 .

During the three months ended March 31, 2024, the Company sold the entire investments in U.S.

Treasury securities.

Total 674,262 — 9,011 665,251

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 September 30, 2023.

Investments in Equity Securities

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

March 31, December 31,

Equity securities with readily determinable fair values (1)

Leap Therapeutics, Inc.

In January 2020, the Company purchased $ 5,000 of Series B mandatorily convertible, non-voting preferred stock of Leap in connection with a strategic collaboration and license agreement the Company entered into with Leap.

The Series B shares were subsequently converted into shares of Leap common stock and warrants to purchase additional shares of common stock upon approval of Leap's shareholders in March 2020.

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

As of 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 1,954 3,046

Fair value of Leap warrants 222 542

Private Equity Securities without Readily Determinable Fair Values

The Company invests in equity securities of certain companies whose securities are not publicly traded and fair value is not readily determinable and where the Company has concluded it does not have significant influence based on its ownership percentage and other factors.

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

The Company held investments of $ 57,631 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

Equity securities without readily determinable fair values

Pi Health, Inc.

54,919 55,860

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 $ 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,

41,119 25,981

Other income (expense), net

Total 139,012 85,429

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

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

(2) In the first quarter of 2024, the Company divested the net assets comprising substantially all of its Pi Health business with a carrying value of $ 38,063 .

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

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

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

The following table summarizes unrealized (losses) gains related to equity securities recorded in other income, net for the three months ended March 31, 2024 and 2023:

Three Months Ended

Equity securities with readily determinable fair values

( 1,412 ) ( 1,107 )

Equity securities without readily determinable fair values ( 797 ) 1,081

Equity-method investments

( 856 ) ( 144 )

Inventories, Net

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

September 30, December 31,

March 31, December 31,

Raw materials 157,735 148,772

4 unchanged sentences

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

September 30, December 31,

March 31, December 31,

Land 65,485 65,485

8 unchanged sentences

Property, plant and equipment, net 1,417,992 1,324,154

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.

The Company is making a significant investment in its future manufacturing and R&D center in the U.S., a 42 -acre site that is being constructed in Hopewell, New Jersey.

As of March 31, 2024, the Company had land and construction in progress of $ 652,369 related to the Hopewell facility.

In March 2024, the Company acquired a land use right and the facility currently being constructed on the land for $ 73,853 in Shanghai, China.

Based on the relative fair values of the land use right and construction in progress, $ 28,887 of the total purchase price was allocated to the land use right and $ 44,966 was allocated to the construction in progress.

As of March 31, 2024, title and risk of loss associated with the acquired properties were being transitioned to the Company.

As such, the purchase price allocated to the land use right was recorded as a long-term prepaid as of March 31, 2024 and will be transferred to operating lease right-of-use asset upon the closing of the transaction.

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

Depreciation expense was $ 24,110 and $ 19,025 for the three months ended March 31, 2024 and 2023, respectively.

Intangible Assets

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

September 30, 2023 December 31, 2022

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

March 31, 2024 December 31, 2023

carrying Accumulated Intangible carrying Accumulated Intangible

1 unchanged sentence

Finite-lived intangible assets:

Product distribution rights 7,500 ( 5,663 ) 1,837 7,500 ( 4,000 ) 3,500

Developed products 63,413 ( 8,913 ) 54,500 64,274 ( 7,807 ) 56,467

Trading license 816 ( 816 ) — 816 ( 816 ) —

Other 8,987 ( 8,316 ) 671 8,987 ( 8,316 ) 671

Total finite-lived intangible assets 72,400 ( 17,229 ) 55,171 73,261 ( 16,123 ) 57,138

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, 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.

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

The Company is amortizing the developed products over the remainder of the respective product patent or the term of the commercialization agreements.

Trading license represents the Guangzhou drug distribution license acquired in September 2018.

The Company amortized the drug distribution trading license over the remainder of the initial license term through February 2020.

The trading license has been renewed through February 2024.

Amortization expense for developed products is included in cost of sales - product in the accompanying consolidated statements of operations.

Amortization expense for product distribution rights and the trading licenses is included in operating expenses in the accompanying consolidated statements of operations.

Amortization expense for other intangible assets is included in operating expenses in the accompanying consolidated statements of operations.

The weighted-average life for each finite-lived intangible assets is approximately 12 years.

Amortization expense was as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

Three Months Ended

Amortization expense - Cost of sales - product

981 800 2,620 2,444

Amortization expense - Operating expense

1,287 187 1,662 563

Total 1,183 986

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

Estimated amortization expense for each of the five succeeding years and thereafter, as of March 31, 2024 is as follows:

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

7 unchanged sentences

Total 54,500 671 55,171

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.

Income tax expense was $ 7,724 and $ 11,492 for the three months ended March 31, 2024 and 2023, respectively.

The Company is anticipating a lower annual effective tax rate in 2024 due to the forecasted jurisdictional mix of consolidated pre-tax earnings, which is expected to increase in jurisdictions where the Company has tax attributes to offset current tax expense.

The income tax expense for the three months ended March 31, 2024 and 2023 was primarily attributable to current U.S.

tax expense determined after other special tax deductions and research and development tax credits and current China tax expense due to certain non-deductible expenses.

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

1 unchanged sentence

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

After consideration of all positive and negative evidence, as of September 30, 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 .

After consideration of all positive and negative evidence, as of March 31, 2024, the Company will maintain a full valuation allowance against its net deferred tax assets.

As of March 31, 2024, the Company had gross unrecognized tax benefits of $ 14,924 .

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

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

The Company’s reserve for uncertain tax positions increased by $ 660 in the three months ended March 31, 2024 primarily due to U.S.

federal and state tax credits and incentives.

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 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.

states and other non-US tax jurisdictions in which the Company files tax returns remain open to examination for 2012 through 2023.

Supplemental Balance Sheet Information

Prepaid expenses and other current assets consist of the following:

September 30, December 31,

March 31, December 31,

Prepaid research and development costs 66,772 60,476

2 unchanged sentences

Other receivables 31,818 37,859

Prepaid commercial 1,089 1,461

Interest receivable 1,628 3,039

Short-term restricted cash 11,445 11,473

Prepaid insurance 7,899 8,872

2 unchanged sentences

Other non-current assets consist of the following:

September 30, December 31,

March 31, December 31,

Prepayment of property and equipment (1) 30,834 4,144

3 unchanged sentences

Long-term restricted cash 2,621 2,711

Long-term investments 89,281 91,779

Long-term investments (Note 4) 143,615 89,644

Total 199,021 125,362

(1) Represents payments for future supply purchases under the license agreement with Luye Pharma Group and facility expansion under commercial supply agreements.

The payments are providing future benefit to the Company through credits on commercial supply purchases.

(1) Includes payment for acquired land use right in Shanghai, China that was being transitioned to the Company as of March 31, 2024 (See Note 6).

Accrued expenses and other payables consist of the following:

September 30, December 31,

March 31, December 31,

Compensation related 114,657 217,803

6 unchanged sentences

Other long-term liabilities consist of the following:

September 30, December 31,

March 31, December 31,

Deferred government grant income 32,939 34,204

Pension liability 14,428 14,995

Asset retirement obligation 1,108 1,127

Other 426 484

Total 48,901 50,810

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

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

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

September 30, 2023 December 31, 2022

March 31, 2024 December 31, 2023

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

April 4, 2027 (1) 13,850 100,000 14,089 100,000

China Merchants Bank January 22, 2020 (2) 9 -year

China Merchants Bank January 22, 2020 RMB 350,000 9 -year

January 20, 2029 (2) 8,706 62,857 8,856 62,857

1 unchanged sentence

November 8, 2029 (3) 6,220 44,910 5,636 40,000

China Minsheng Bank (the “Senior Loan”) September 24, 2020 $ 200,000 (4) 4.3 % 150,000 1,095,130 150,000 1,034,554

Shanghai Pudong Development Bank February 25, 2022 $ 50,000 1 -year

February 25, 2023 2.2 % — — 50,000 344,851

China Merchants Bank July 28, 2023 $ 380,000 1 -year

December 25, 2024 (4) 300,000 2,166,065 300,000 2,129,321

China Minsheng Bank December 20, 2023 $ 150,000 1 -year

December 19, 2024 7.3 % 150,000 1,083,032 150,000 1,064,660

China Industrial Bank March 21, 2024 RMB 675,000 364 -day

March 27, 2025 (5) 93,488 675,000 — —

China Merchants Bank June 5, 2023 RMB 400,000 1 -year

4 unchanged sentences

May 29, 2024 2.8 % 27,699 200,000 28,177 200,000

Shanghai Pudong Development Bank November 14, 2023 RMB 700,000 1 -year

(7) 2.9 % 96,950 700,000 49,312 350,000

Other short-term debt (8) 27,562 199,000 28,037 199,000

2 unchanged sentences

April 4, 2027 (1) 58,170 420,000 59,174 420,000

China Merchants Bank January 22, 2020 (2) 9 -year

China Merchants Bank January 22, 2020 RMB 350,000 9 -year

January 20, 2029 (2) 34,823 251,429 37,638 267,143

5 unchanged sentences

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 September 30, 2023.

The loan interest rate was 4.5 % as of March 31, 2024.

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 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.

The loan is secured by Guangzhou Factory's second land use right and fixed assets placed into service upon completion of the second phase of the Guangzhou manufacturing facility's build out.

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

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

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

The Company was in the process of substituting the land use right with the real estate interest in BeiGene Guangzhou Factory as collateral of the loan as of March 31, 2024.

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

The loan interest rate was 4.1 % as of March 31, 2024.

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

The Company repaid $ 2,189 (RMB 15,714 ) during the three months ended March 31, 2024.

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

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

The loan interest rate was 3.9 % as of March 31, 2024.

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

The Company repaid $ 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.

(“BeiGene Biologics”) from Guangzhou GET Technology Development Co., Ltd.

(now Guangzhou High-tech Zone Technology Holding Group Co., Ltd.) (“GET”) and repayment of the loan provided by GET (“Shareholder Loan”) and $ 80,000 was designated for general working capital purposes.

The Senior Loan had an original maturity date of October 8, 2021, which was the first anniversary of the first date of utilization of the loan.

The Company may extend the original maturity date for up to two additional 12 month periods.

On October 8, 2021, the Company extended the maturity date for twelve months to October 8, 2022 and repurposed the Senior Loan for general working capital purposes.

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

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

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 May 24, 2023.

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.

The Company repaid $ 1,390 (RMB 10,000 ) during the three months ended March 31, 2024.

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

The loan interest rate was 7.2 % as of March 31, 2024.

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

The loan interest rate was 2.6 % as of March 31, 2024.

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

The loan interest rate was 5.2 % as of March 31, 2024.

$ 48,475 (RMB 350,000 ) of the outstanding borrowings matures on November 21, 2024 and March 19, 2025, respectively.

During the two years ended December 31, 2023, the Company entered into short-term working capital loans with China Industrial Bank and China Merchants Bank to borrow up to RMB 875,000 in aggregate, with maturity dates ranging from December 15, 2022 to May 24, 2024.

The weighted average interest rate for the short-term working capital loans was approximately 3.2 % as of March 31, 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 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.

The Company drew down $ 9,053 (RMB 65,000 ) during the three months ended March 31, 2024.

The weighted average loan interest rate was 3.9 % as of March 31, 2024.

The loan is secured by BeiGene Suzhou Co., Ltd.’s land use right and certain fixed assets that will be placed into service upon completion of the small molecule manufacturing campus in Suzhou, China.

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

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

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

Any acceleration would be a matter of months but may impact the Company’s ability to refinance debt obligations if an event of default occurs.

As of March 31, 2024, the Company was in compliance with all covenants of its material debt agreements.

Interest Expense

Interest expense recognized for the three and nine months ended September 30, 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.

Interest expense recognized for the three months ended March 31, 2024 and 2023 was $ 12,404 and $ 4,574 , respectively, among which, $ 9,209 and $ 344 was capitalized, respectively.

Product Revenue

The Company’s product revenue is primarily derived from the sale of its internally developed products BRUKINSA in the United States China, and other regions, and tislelizumab and pamiparib in China;

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

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

REVLIMID ® and VIDAZA ® in China under a license from BMS;

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

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

The table below presents the Company’s net product sales for the three months ended March 31, 2024 and 2023.

Three Months Ended

Product revenue – gross 944,464 509,605

1 unchanged sentence

Product revenue – net 746,918 410,291

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

The following table disaggregates net product sales by product for the three months ended March 31, 2024 and 2023:

Three Months Ended

488,515 211,382

4 unchanged sentences

12,233 23,158

11,101 2,820 27,096 11,225

4,320 3,314 11,439 12,260

Pamiparib 1,887 1,266 5,612 5,843

Other 12,402 10,489

Total product revenue – net 746,918 410,291

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,

The following table presents the roll-forward of accrued sales rebates and returns for the three months ended March 31, 2024 and 2023:

Three Months Ended

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

2 unchanged sentences

Balance at end of the period 186,277 78,732

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 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.

Loss Per Share

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

Three Months Ended

Net loss ( 251,150 ) ( 348,431 )

Weighted average shares outstanding for computing basic and diluted loss per share 1,355,547,626 1,354,164,760

Loss per share ( 0.19 ) ( 0.26 )

For the three months ended March 31, 2024 and 2023, the computation of basic loss per share using the two-class method was not applicable as the Company was in a net loss position, and the effects of all share options, restricted shares, restricted share units and ESPP shares were excluded from the calculation of diluted loss per share, as their effect would have been anti-dilutive.

Share-Based Compensation Expense

2 unchanged sentences

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 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 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.

2”), which became effective as of June 22, 2022, to increase the number of authorized shares available for issuance under the 2016 Plan by 66,300,000 ordinary shares, or 5 % of the Company’s outstanding shares as of March 31, 2022.

2018 Inducement Equity Plan

In June 2018, the board of directors of the Company approved the 2018 Inducement Equity Plan (the “2018 Plan”) and reserved 12,000,000 ordinary shares to be used exclusively for grants of awards to individuals that were not previously employees of the Company or its subsidiaries, as a material inducement to the individual’s entry into employment with the Company or its subsidiaries within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules.

The 2018 Plan was approved by the board of directors upon recommendation of the compensation committee, without shareholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The terms and conditions of the 2018 Plan, and the forms of award agreements to be used thereunder, are substantially similar to the 2016 Plan and the forms of award agreements thereunder.

In August 2018, in connection with the 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 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.

2 to the 2016 Plan, on June 22, 2022, the 2018 Plan was terminated to the effect that no new equity awards shall be granted under the plan but the outstanding equity awards under the plan shall continue to vest and/or be exercisable in accordance with their terms.

As of March 31, 2024, ordinary shares cancelled or forfeited under the 2011 Plan that were carried over to the 2016 Plan totaled 5,166,822 .

During the three months ended March 31, 2024, the Company granted options for 180,323 ordinary shares and restricted share units for 2,757,547 ordinary shares under the 2016 Plan.

As of March 31, 2024, options and restricted share units for ordinary shares outstanding under the 2016 Plan totaled 60,637,471 and 65,397,709 , respectively.

As of March 31, 2024, share-based awards to acquire 36,894,454 ordinary shares were available for future grant under the 2016 Plan.

2018 Employee Share Purchase Plan

7 unchanged sentences

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

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

As of March 31, 2024, 919,678 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 29, 2024 1,021,397 $ 165.65 $ 12.74 $ 140.80 $ 10.83 $ 11,063

3 unchanged sentences

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 nine months ended September 30, 2023 and 2022:

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

Share-Based Compensation Expense

The following table summarizes total share-based compensation expense recognized for the three months ended March 31, 2024 and 2023:

Three Months Ended

Research and development 38,045 34,028

9 unchanged sentences

Net-current period other comprehensive (loss) income ( 32,163 ) ( 35 ) — ( 32,198 )

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

Balance as of March 31, 2024 ( 120,150 ) — ( 11,494 ) ( 131,644 )

Shareholders’ Equity

7 unchanged sentences

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

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

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

5 unchanged sentences

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 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.

As of March 31, 2024 and December 31, 2023, the net cash of the Company’s PRC subsidiaries amounted to $ 1,660,848 and $ 1,837,790 , respectively .

Commitments and Contingencies

Purchase Commitments

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.

As of March 31, 2024, the Company had non-cancellable purchase commitments amounting to $ 93,511 , of which $ 35,405 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $ 58,106 related to binding purchase obligations of inventory from Amgen.

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

Capital Commitments

The Company had capital commitments amounting to $ 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.

The Company had capital commitments amounting to $ 61,577 for the acquisition of property, plant and equipment as of March 31, 2024, which were mainly for the Company’s manufacturing and clinical R&D campus in Hopewell, New Jersey, additional capacity at the Guangzhou and Suzhou manufacturing facilities, and a new building for Beijing Innerway Bio-tech Co., Ltd.

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 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 three years .

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

As of March 31, 2024, the Company’s remaining co-development funding commitment was $ 457,031 .

Funding Commitment

The Company had committed capital related to two equity method investments in the amount of $ 15,054 .

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.

As of March 31, 2024, the remaining capital commitment was $ 8,905 and is expected to be paid from time to time over the investment period.

Segment and Geographic Information

2 unchanged sentences

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

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

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

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

Total revenues by geographic area are presented as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2023 2022 2023 2022

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

Three Months Ended

- total revenue 351,456 164,483

Product revenue 351,456 138,768

6 unchanged sentences

Collaboration revenue 20 11,020

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

Rest of world- total revenue 12,960 5,116

Product revenue 12,960 5,116

Collaboration revenue — —

Total Revenue 751,652 447,801

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