What changed in this filing

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Item 1. Financial Statements

2024-11-12 compared with 2024-08-07 · 190 added, 172 removed, 564 unchanged (39% of the section changed)

4 unchanged sentences

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

Three Months Ended Six Months Ended

June 30, June 30,

Three Months Ended Nine Months Ended

September 30, September 30,

Note 2024 2023 2024 2023

7 unchanged sentences

Selling, general and administrative 455,223 365,708 1,326,379 1,089,616

Amortization of intangible assets — 188 — 375

Total operating expenses 951,402 818,967 2,737,662 2,374,223

1 unchanged sentence

Interest income, net 10,643 26,649 40,028 57,735

Other expense, net ( 11,984 ) ( 63,818 ) ( 10,222 ) ( 45,515 )

Loss before income taxes ( 105,920 ) ( 367,463 ) ( 349,346 ) ( 704,402 )

Other income, net 11,318 336,657 1,096 291,142

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

Income tax expense 8 23,046 13,925 45,255 39,091

Net loss ( 120,405 ) ( 381,137 ) ( 371,555 ) ( 729,568 )

Net loss per share, basic and diluted 12 ( 0.09 ) ( 0.28 ) ( 0.27 ) ( 0.54 )

Weighted-average shares outstanding—basic and diluted 1,361,082,567 1,360,224,377 1,358,315,145 1,357,211,308

Net loss per American Depositary Share (“ADS”), basic and diluted 12 ( 1.15 ) ( 3.64 ) ( 3.56 ) ( 6.99 )

Weighted-average ADSs outstanding—basic and diluted 104,698,659 104,632,644 104,485,780 104,400,870

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

(Loss) earnings per share

Basic 12 ( 0.09 ) 0.16 ( 0.36 ) ( 0.38 )

Diluted 12 ( 0.09 ) 0.15 ( 0.36 ) ( 0.38 )

Weighted-average shares outstanding—basic 1,376,751,873 1,360,716,279 1,361,216,763 1,358,392,470

Weighted-average shares outstanding—diluted 1,376,751,873 1,390,331,833 1,361,216,763 1,358,392,470

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

Basic 12 ( 1.15 ) 2.06 ( 4.71 ) ( 4.92 )

Diluted 12 ( 1.15 ) 2.01 ( 4.71 ) ( 4.92 )

Weighted-average ADSs outstanding—basic 105,903,990 104,670,483 104,708,982 104,491,728

Weighted-average ADSs outstanding—diluted 105,903,990 106,948,603 104,708,982 104,491,728

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

3 unchanged sentences

Dollars (“$”))

Three Months Ended Six Months Ended

June 30, June 30,

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

Net loss ( 120,405 ) ( 381,137 ) ( 371,555 ) ( 729,568 )

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

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

1 unchanged sentence

Pension liability adjustments 202 — 608 —

Unrealized holding (loss) income, net — 1,846 ( 35 ) 6,902

Comprehensive loss ( 129,235 ) ( 465,810 ) ( 412,583 ) ( 795,838 )

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

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

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

3 unchanged sentences

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

June 30, December 31,

September 30, December 31,

Note 2024 2023

33 unchanged sentences

9,500,000,000 shares authorized;

1,379,101,901 and 1,359,513,224 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively

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

Additional paid-in capital 11,974,415 11,598,688

8 unchanged sentences

Dollars (“$”))

Six Months Ended June 30,

Nine Months Ended September 30,

Note 2024 2023

4 unchanged sentences

Share-based compensation expenses 13 334,001 274,697

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

Acquired in-process research and development — 15,000

Amortization of research and development cost share liability 3 ( 51,614 ) ( 38,569 )

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

Other items, net 11,516 13,830

36 unchanged sentences

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

Acquired intangible asset included in accounts payable — 9,384

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

22 unchanged sentences

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

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

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

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

Other comprehensive income — — — 56,949 — 56,949

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

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

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

11 unchanged sentences

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

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

17 unchanged sentences

(“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.

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 a fully dedicated 3,000 + person clinical team that is largely CRO free, the majority of which are in the Americas, Europe, Australia, Japan and Korea.

Basis of presentation and consolidation

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

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

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

3 unchanged sentences

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

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

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

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

8 unchanged sentences

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

Improvements to Reportable Segment Disclosures.

Improvements to Reportable Segment Disclosures, which amended ASC 280.

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

2 unchanged sentences

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.

The Company operates in one segment:

pharmaceutical products.

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

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

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

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

10 unchanged sentences

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 six months ended June 30, 2024, as compared to the significant accounting policies described in the Annual Report.

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

Fair Value Measurements

8 unchanged sentences

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

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

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

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

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

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

Cash equivalents

10 unchanged sentences

Money market funds 1,052,149 — —

Time deposits 42,852 — —

Prepaid expenses and other current assets:

16 unchanged sentences

The Company 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 expense, net.

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

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

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

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

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

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

6 unchanged sentences

Out-Licensing Arrangements

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

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

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

Three Months Ended Six Months Ended

June 30, June 30,

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

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

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

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

2 unchanged sentences

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

Material rights revenue — 71,980 — 71,980

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

7 unchanged sentences

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.

No research and development service collaboration revenue was recognized in connection with the tislelizumab collaboration and license agreement during the three and six months ended June 30, 2024 due to termination of the agreement in 2023.

The following table summarizes revenue recognized related to the sale of tislelizumab clinical supply to Novartis for the three and six months ended June 30, 2024 and research and development service revenue recognized for the three and six months ended June 30, 2023:

Three Months Ended Six Months Ended

June 30, June 30,

2024 2023 2024 2023

Research and development service revenue — 11,770 — 16,796

2,113 1,344 2,113 5,013

Total 2,113 13,114 2,113 21,809

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

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

3 unchanged sentences

The China broad markets agreement remains in place.

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

Three Months Ended Six Months Ended

June 30, June 30,

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

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

1 unchanged sentence

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

Material rights revenue — 71,980 71,980

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

1 unchanged sentence

In-Licensing Arrangements - Commercial

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

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

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

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

Three Months Ended Six Months Ended

June 30, June 30,

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

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

2 unchanged sentences

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

June 30, 2024

September 30, 2024

Remaining portion of development funding cap 379,057

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

June 30, December 31,

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

September 30, December 31,

Research and development cost share liability, current portion 104,067 68,004

1 unchanged sentence

Total research and development cost share liability 187,052 238,666

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

Three Months Ended Six Months Ended

June 30, June 30,

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

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

4 unchanged sentences

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

Inventory purchases amounted to $ 47,653 and $ 109,879 during the three and six months ended June 30, 2024, respectively, and $ 20,146 and $ 39,277 during the three and six months ended June 30, 2023, respectively.

Net amounts payable to Amgen was $ 66,824 and $ 55,474 as of June 30, 2024 and December 31, 2023, respectively.

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

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

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 incurred under these arrangements for the three and six months ended June 30, 2024 and 2023 are set forth below.

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

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

Three Months Ended Six Months Ended

June 30, June 30,

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

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

2 unchanged sentences

Development milestones incurred Research and development expense 5,000 — 51,500 —

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

Total 5,000 24,379 51,527 33,612

3 unchanged sentences

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

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

June 30, December 31,

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

September 30, December 31,

Short-term restricted cash 9,284 11,473

2 unchanged sentences

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

As of June 30, 2024, the Company had cash remaining related to the STAR Offering proceeds of $ 856,722 .

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

Investments in Equity Securities

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

June 30, December 31,

September 30, December 31,

Equity securities with readily determinable fair values 1

8 unchanged sentences

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 expense, net.

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 expense, net during the six months ended June 30, 2024.

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

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

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

Three Months Ended Six Months Ended

June 30, June 30,

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

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

6 unchanged sentences

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

June 30, December 31,

September 30, December 31,

Raw materials 147,297 148,772

4 unchanged sentences

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

June 30, December 31,

September 30, December 31,

Land 65,485 65,485

9 unchanged sentences

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

As of June 30, 2024, the Company had land and construction in progress of $ 677,126 related to the Hopewell facility, the majority of which will be put into service in the second half of 2024.

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

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

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

2 unchanged sentences

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

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

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

Depreciation expense was $ 23,754 and $ 47,864 for the three and six months ended June 30, 2024, respectively, and $ 21,307 and $ 40,332 for the three and six months ended June 30, 2023, respectively.

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

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

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

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

Intangible Assets

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

June 30, 2024 December 31, 2023

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

September 30, 2024 December 31, 2023

carrying Accumulated Intangible carrying Accumulated Intangible

7 unchanged sentences

Amortization expense for developed products is included in cost of sales - product 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.

Amortization expense for other intangible assets is included in selling, general and administrative expense 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 Six Months Ended

June 30, June 30,

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

1 unchanged sentence

1,186 981 3,546 2,620

Amortization expense - Operating expense

Amortization expense - Selling, general and administrative

78 1,287 78 1,662

Total 1,264 2,268 3,624 4,282

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

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

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

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

2024 (remainder of year)

6 unchanged sentences

Total 53,346 593 53,939

Income tax expense was $ 14,485 and $ 22,209 for the three and six months ended June 30, 2024, respectively, and $ 13,674 and $ 25,166 for the three and six months ended June 30, 2023, respectively.

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

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

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

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

2 unchanged sentences

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

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

As of June 30, 2024, the Company had gross unrecognized tax benefits of $ 15,804 .

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

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

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 $ 880 and $ 1,540 in the three and six months ended June 30, 2024 primarily due to U.S.

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

federal and state tax credits and incentives.

1 unchanged sentence

Prepaid expenses and other current assets consist of the following:

June 30, December 31,

September 30, December 31,

Prepaid research and development costs 60,227 60,476

Prepaid manufacturing cost 32,986 42,066

Prepaid taxes 25,048 37,320

Other receivables 33,967 37,859

Prepaid manufacturing cost 28,849 42,066

Prepaid general and administrative expenses 16,183 14,619

Short-term restricted cash 9,284 11,473

Deposits 7,860 26,753

Prepaid insurance 6,180 8,872

2 unchanged sentences

Other non-current assets consist of the following:

June 30, December 31,

September 30, December 31,

Prepayment of property and equipment 1

Prepaid supply cost 12,779 18,122

Prepaid VAT 2,602 2,546

Rental deposits and other 9,180 8,195

Prepaid VAT 2,807 2,546

Long-term restricted cash 2,211 2,711

1 unchanged sentence

Total 201,174 125,362

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

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

Accrued expenses and other payables consist of the following:

June 30, December 31,

September 30, December 31,

Revenue rebates and returns related 213,747 139,936

Compensation related 211,856 217,803

2 unchanged sentences

Individual income tax and other taxes 34,550 30,083

Sales rebates and returns related 173,263 139,936

Accrued general and administrative expenses 30,830 36,203

Other 33,473 19,165

1 unchanged sentence

Other long-term liabilities consist of the following:

June 30, December 31,

September 30, December 31,

Deferred government grant income 32,429 34,204

3 unchanged sentences

Total 50,568 50,810

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

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

Lender Line of Credit Term Maturity Date Interest Rate As of

June 30, 2024 December 31, 2023

September 30, 2024 December 31, 2023

China Construction Bank RMB 580,000 9 -year

April 4, 2027 (1) 15,136 110,000 14,089 100,000

June 11, 2027 1 15,675 110,000 14,089 100,000

China Merchants Bank RMB 350,000 9 -year

17 unchanged sentences

Other short-term debt 8

— — 28,037 199,000

Total short-term debt 863,803 6,061,776 688,366 4,885,838

China Construction Bank RMB 580,000 9 -year

April 4, 2027 (1) 49,536 360,000 59,174 420,000

June 11, 2027 1 51,300 360,000 59,174 420,000

China Merchants Bank RMB 350,000 9 -year

6 unchanged sentences

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

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

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

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

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

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

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

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

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

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

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

The Company repaid $ 4,362 (RMB 31,429 ) during the six months ended June 30, 2024.

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

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

The loan interest rate was 3.9 % as of June 30, 2024.

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

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

The Company repaid $ 2,772 (RMB 20,000 ) during the six months ended June 30, 2024.

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

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

The loan interest rate was 7.2 % as of June 30, 2024.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The weighted average loan interest rate was 3.9 % as of June 30, 2024.

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

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

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

3 unchanged sentences

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

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

Interest Expense

Interest expense recognized for the three and six months ended June 30, 2024 was $ 13,233 and $ 25,637 , respectively, among which, $ 8,312 and $ 17,521 was capitalized, respectively.

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

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

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

Product Revenue

2 unchanged sentences

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

The table below presents the Company’s net product sales for the three and six months ended June 30, 2024 and 2023.

Three Months Ended Six Months Ended

June 30, June 30,

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

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

2 unchanged sentences

Product revenue – net 993,447 595,290 2,661,511 1,559,326

The following table disaggregates net product sales by product for the three and six months ended June 30, 2024 and 2023:

Three Months Ended Six Months Ended

June 30, June 30,

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

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

8 unchanged sentences

Total product revenue – net 993,447 595,290 2,661,511 1,559,326

The following table presents the roll-forward of accrued sales rebates and returns for the six months ended June 30, 2024 and 2023:

Six Months Ended

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

Nine Months Ended

September 30,

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

2 unchanged sentences

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

Loss Per Share

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

Three Months Ended Six Months Ended

June 30, June 30,

(Loss) Earnings Per Share

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

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

Net loss ( 120,405 ) ( 381,137 ) ( 371,555 ) ( 729,568 )

Weighted average shares outstanding for computing basic and diluted loss per share 1,361,082,567 1,360,224,377 1,358,315,145 1,357,211,308

Loss per share ( 0.09 ) ( 0.28 ) ( 0.27 ) ( 0.54 )

For the three and six months ended June 30, 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.

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

Weighted-average shares outstanding—basic 1,376,751,873 1,360,716,279 1,361,216,763 1,358,392,470

Effect of dilutive securities:

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

Weighted-average shares outstanding—diluted 1,376,751,873 1,390,331,833 1,361,216,763 1,358,392,470

(Loss) earnings per share

Basic ( 0.09 ) 0.16 ( 0.36 ) ( 0.38 )

Diluted ( 0.09 ) 0.15 ( 0.36 ) ( 0.38 )

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

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

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.

Share-Based Compensation Expense

Share Option and Incentive Plan

In January 2016, in connection with the Company’s initial public offering (“IPO”) on the Nasdaq Stock Market, the board of directors and shareholders of the Company approved the 2016 Share Option and Incentive Plan (the “2016 Plan”), which became effective in February 2016.

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

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

In June 2020, the shareholders approved an amendment to the 2016 Plan to increase the number of shares authorized for issuance by 57,200,000 ordinary shares and to extend the term of the plan through April 13, 2030.

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

In order to continue to provide incentive opportunities under the 2016 Plan, the Board of Directors and shareholders of the Company approved another 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.

In June 2024, the shareholders of the Company approved a third amended and restated 2016 Plan (the “Amended 2016 Plan”) to comply with certain amendments of Chapter 17 of the Rules Governing the Listing of Securities on the Stock Exchange of Hong Kong Limited (the “HK Listing Rules”) and to increase the number of shares available for issuance thereunder by 92,820,000 ordinary shares.

As of June 30, 2024, ordinary shares cancelled or forfeited under the 2011 Plan that were carried over to the Amended 2016 Plan totaled 5,166,848 .

During the six months ended June 30, 2024, the Company granted options for 8,394,737 ordinary shares, restricted share units for 42,514,355 ordinary shares, and performance share units for 2,287,402 ordinary shares under the Amended 2016 Plan.

As of June 30, 2024, options, restricted share units, and performance share units for ordinary shares outstanding under the Amended 2016 Plan totaled 67,378,462 , 87,422,244 , and 2,287,402 , respectively.

As of June 30, 2024, share-based awards to acquire 82,059,496 ordinary shares were available for future grant under the Amended 2016 Plan.

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

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

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

Employee Share Purchase Plan

In June 2018, the shareholders of the Company approved the 2018 Employee Share Purchase Plan (the “ESPP”).

Initially, 3,500,000 ordinary shares of the Company were reserved for issuance under the ESPP.

In August 2018, in connection with the Company’s listing on the Hong Kong Stock Exchange, the board of directors approved an amended and restated ESPP to remove an “evergreen” share replenishment provision originally included in the plan and implemented other changes required by the HK Listing Rules.

In December 2018, the shareholders of the Company approved a second amended and restated ESPP to increase the number of shares authorized for issuance by 3,855,315 ordinary shares to 7,355,315 ordinary shares.

In June 2019, the board of directors adopted an amendment to revise the eligibility criteria for enrollment in the plan.

In June 2021, the board of directors of the Company adopted the third amended and restated ESPP to include certain technical amendments under U.S.

tax rules and to consolidate the changes in the prior amendment, effective on September 1, 2021.

In June 2024, the shareholders approved a fourth amended and restated ESPP (the “Amended ESPP”) to comply with certain amendments of Chapter 17 of the HK Listing Rules and to increase the number of shares available for sale thereunder by 5,070,000 shares.

The Amended ESPP allows eligible employees to purchase the Company’s ordinary shares (including in the form of ADSs) at the end of each offering period, which will generally be six months , at a 15 % discount to the market price of the Company’s ADSs at the beginning or the end of each offering period, whichever is lower, using funds deducted from their payroll during the offering period.

The Company’s employee share purchase plan (the “ESPP”) allows eligible employees to purchase the Company’s ordinary shares (including in the form of ADSs) at the end of each offering period, which will generally be six months , at a 15 % discount to the market price of the Company’s ADSs at the beginning or the end of each offering period, whichever is lower, using funds deducted from their payroll during the offering period.

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

As of June 30, 2024, 5,989,678 ordinary shares were available for future issuance under the Amended ESPP.

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

The following tables summarizes the shares issued under the ESPP:

2 unchanged sentences

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

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

February 29, 2024 1,021,397 $ 165.65 $ 12.74 $ 140.80 $ 10.83 $ 11,063

4 unchanged sentences

Share-Based Compensation Expense

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

Three Months Ended Six Months Ended

June 30, June 30,

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

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

8 unchanged sentences

Balance as of December 31, 2023 ( 87,987 ) 35 ( 11,494 ) ( 99,446 )

Other comprehensive (loss) income before reclassifications ( 41,399 ) ( 35 ) — ( 41,434 )

Amounts reclassified from accumulated other comprehensive income (loss) — — 406 406

Net-current period other comprehensive (loss) income ( 41,399 ) ( 35 ) 406 ( 41,028 )

Balance as of June 30, 2024 ( 129,386 ) — ( 11,088 ) ( 140,474 )

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

Amounts reclassified from accumulated other comprehensive loss — — 608 608

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

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

Shareholders’ Equity

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 expense, net in the consolidated statements of operations.

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

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

10 unchanged sentences

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

As of June 30, 2024 and December 31, 2023, the net cash of the Company’s PRC subsidiaries amounted to $ 1,378,872 and $ 1,837,790 , respectively .

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

Commitments and Contingencies

Purchase Commitments

As of June 30, 2024, the Company had non-cancellable purchase commitments amounting to $ 120,366 , of which $ 28,822 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $ 91,544 related to binding purchase obligations of inventory from Amgen.

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

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

Capital Commitments

The Company had capital commitments amounting to $ 62,576 for the acquisition of property, plant and equipment as of June 30, 2024, related to various facilities across the globe, including the manufacturing and clinical R&D campus in Hopewell, New Jersey.

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

Co-Development Funding Commitment

1 unchanged sentence

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

As of June 30, 2024, the Company’s remaining co-development funding commitment was $ 412,647 .

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

Funding Commitment

The Company had committed capital related to two equity-method investments in the amount of $ 15,056 .

As of June 30, 2024, the remaining capital commitment was $ 8,154 and is expected to be paid from time to time over the investment period.

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

Segment and Geographic Information

5 unchanged sentences

Total revenues by geographic area are presented as follows:

Three Months Ended Six Months Ended

June 30, June 30,

Three Months Ended Nine Months Ended

September 30, September 30,

2024 2023 2024 2023

13 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements