What changed in this filing

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Item 1. Financial Statements

2026-05-06 compared with 2025-11-06 · 216 added, 289 removed, 477 unchanged (51% of the section changed)

4 unchanged sentences

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

Three Months Ended Nine Months Ended

September 30, September 30,

Three Months Ended

Note 2026 2025

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Total operating expenses 1,096,321 941,175

Income (loss) from operations 163,114 ( 120,265 ) 262,101 ( 488,774 )

Interest income, net 3,029 10,643 12,374 40,028

Other (expense) income, net ( 18,979 ) 11,318 ( 6,862 ) 1,096

Income (loss) before income taxes 147,164 ( 98,304 ) 267,613 ( 447,650 )

Income from operations 249,902 11,102

Interest income 27,664 12,850

Interest expense ( 32,887 ) ( 7,002 )

Other income, net 14,536 3,950

Income before income taxes 259,215 20,900

Income tax expense 8 31,858 19,630

Net income (loss) 124,841 ( 121,350 ) 220,431 ( 492,905 )

Earnings (loss) per share

Net income 227,357 1,270

Earnings per share

Basic 12 0.16 0.00

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Weighted-average shares outstanding—diluted 1,505,027,338 1,445,253,219

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

Earnings per American Depositary Share (“ADS”)

Basic 12 2.05 0.01

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BEONE MEDICINES LTD.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(Amounts in thousands of U.S.

Dollars (“$”))

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

Net income (loss) 124,841 ( 121,350 ) 220,431 ( 492,905 )

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

Three Months Ended

Net income 227,357 1,270

Other comprehensive income, net of tax of nil:

Foreign currency translation adjustments 24,470 6,441

Other adjustments 232 226

Comprehensive income (loss) 137,282 ( 64,401 ) 268,162 ( 476,984 )

Comprehensive income 252,059 7,937

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

3 unchanged sentences

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

September 30, December 31,

March 31, December 31,

Note 2026 2025

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Deferred tax liabilities 8 55,866 53,209

Research and development cost share liability, non-current portion 3 — 54,286

Other long-term liabilities 9 81,952 80,245

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Ordinary shares, $ 0.0001 par value per share;

1,540,975,898 and 1,387,367,704 shares issued and 1,438,083,590 and 1,387,367,704 shares outstanding as of September 30, 2025 and December 31, 2024, respectively

1,540,975,898 and 1,540,975,898 shares issued and 1,444,479,378 and 1,441,075,618 shares outstanding as of March 31, 2026 and December 31, 2025, respectively

Additional paid-in capital 12,906,326 12,759,137

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Dollars (“$”))

Nine Months Ended September 30,

Three Months Ended March 31,

Note 2026 2025

Operating activities:

Net income (loss) 220,431 ( 492,905 )

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

Net income 227,357 1,270

Adjustments to reconcile net income to net cash provided by operating activities:

Depreciation and amortization expense 41,144 32,804

Share-based compensation expenses 13 123,355 95,478

Acquired in-process research and development 691 —

Amortization of research and development cost share liability 3 ( 28,645 ) ( 19,812 )

Impairment of equity investments 34,216 —

Non-cash interest expense 21,096 —

Other items, net 6,172 12,369

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Other liabilities 1,731 4,043

Net cash provided by (used in) operating activities 710,233 ( 215,791 )

Net cash provided by operating activities 201,336 44,082

Investing activities:

Purchases of property, plant and equipment ( 40,789 ) ( 56,407 )

Purchase of intangible asset ( 20,000 ) ( 4,674 )

Proceeds from sale or maturity of investments 27 1,800

3 unchanged sentences

Financing activities:

Proceeds from sale of future royalties 4 885,000 —

Proceeds from long-term loan 11 — 9,053

Repayment of long-term loan 10 ( 7,641 ) ( 4,215 )

1 unchanged sentence

Repayment of short-term loans 10 — ( 172,921 )

Payments of withholding taxes from share-based awards ( 24,195 ) —

Repayment of sale of future royalties liability 4 ( 2,557 ) —

Proceeds from option exercises and employee share purchase plan 23,875 63,359

Other financing activities ( 3,249 ) —

Net cash provided by financing activities 962,520 197,972

Net cash provided by (used in) financing activities 68,632 ( 33,777 )

Effect of foreign exchange rate changes, net 19,320 3,480

6 unchanged sentences

Long-term restricted cash 20,910 2,847

Income taxes paid 79,962 54,778

Income taxes (refunded)/paid ( 2,737 ) 9,321

Interest expense paid 12,834 6,247

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ROU assets obtained in exchange for new operating lease liabilities 9,261 15,659

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

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

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Balance at December 31, 2025 1,540,975,898 ( 99,900,280 ) 1,441,075,618 144 12,759,137 ( 78,184 ) ( 8,319,903 ) 4,361,194

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

Exercise of options, ESPP and release of RSUs — 3,403,760 3,403,760 — 23,834 — — 23,834

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Balance at March 31, 2026 1,540,975,898 ( 96,496,520 ) 1,444,479,378 144 12,906,326 ( 53,482 ) ( 8,092,546 ) 4,760,442

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

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

109,306,902 ( 112,772,594 ) ( 3,465,692 ) — — — — —

Exercise of options, ESPP and release of RSUs 15,511,587 — 15,511,587 2 63,874 — — 63,876

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

Withholding taxes from share-based awards — — — — ( 35,523 ) — — ( 35,523 )

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

Net income — — — — — — 1,270 1,270

Balance at June 30, 2025 1,540,975,898 ( 112,772,594 ) 1,428,203,304 143 12,395,276 ( 113,698 ) ( 8,511,246 ) 3,770,475

Exercise of options, ESPP and release of RSUs — 9,880,286 9,880,286 1 80,759 — — 80,760

Share-based compensation — — — — 140,809 — — 140,809

Other comprehensive income — — — — — 12,441 — 12,441

Net income — — — — — — 124,841 124,841

Balance at September 30, 2025 1,540,975,898 ( 102,892,308 ) 1,438,083,590 144 12,616,844 ( 101,257 ) ( 8,386,405 ) 4,129,326

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

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

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

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

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

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

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

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

Issuance of shares reserved for share option exercises 2,418,936 — 2,418,936 — — — — —

Exercise of options, ESPP and release of RSUs 17,158,596 — 17,158,596 1 4,491 — — 4,492

Share-based compensation — — — — 130,637 — — 130,637

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

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

Balance at June 30, 2024 1,379,101,901 — 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 — 1,944,995 — — — — —

Exercise of options, ESPP and release of RSUs 4,987,424 — 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 — 1,386,034,320 138 11,974,415 ( 83,525 ) ( 8,454,955 ) 3,436,073

Upon effectiveness of the redomiciliation to Switzerland, ordinary shares (including in the form of ADS) held by the Company or one of its controlled subsidiaries immediately prior to the effective date of the redomiciliation became part of the Company’s issued but not outstanding share capital and are considered ordinary shares of the Company, or “treasury shares” under Swiss law.

Upon effectiveness of the Continuation, ordinary shares (including in the form of ADS) held by the Company or one of its controlled subsidiaries immediately prior to the effective date of the Continuation became part of the Company’s issued but not outstanding share capital and are considered ordinary shares of the Company, or “treasury shares” under Swiss law.

The Company expects to use these treasury shares in the future to satisfy obligations to deliver shares in connection with awards granted under the Company’s equity incentive plans and agreements.

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Formerly known as BeiGene, Ltd., BeOne Medicines Ltd.

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

The Company redomiciled from the Cayman Islands to Switzerland during the second quarter of 2025.

The redomiciliation to Switzerland did not change the accounting basis under U.S.

(the “Company” or “BeOne”) is a global oncology company discovering and developing innovative treatments that are more accessible to cancer patients worldwide.

Effective May 27, 2025, the Company changed its jurisdiction of incorporation from the Cayman Islands to Switzerland through a transaction known as a continuation under Section 206 of the Companies Act (as amended) of the Cayman Islands and Article 161 of the Swiss Federal Act on Private International Law (such transaction, the “Continuation”), The Continuation did not change the accounting basis under U.S.

generally accepted accounting principles (“GAAP”) of any of the Company’s consolidated assets, liabilities, equity, or any previous results of operations or cash flows.

In connection with the redomiciliation, ordinary shares held by the Company or one of its controlled subsidiaries immediately prior to the effective date of the redomiciliation became part of the Company’s issued share capital and are considered ordinary shares of the Company, or “treasury shares” under Swiss law.

In connection with the Continuation, ordinary shares held by the Company or one of its controlled subsidiaries immediately prior to the effective date of the Continuation became part of the Company’s issued share capital and are considered ordinary shares of the Company, or “treasury shares” under Swiss law.

See the Company’s final prospectus filed with the U.S.

Securities and Exchange Commission pursuant to Rule 424(b)(3) on March 10, 2025 for a full description of the changes related to the Company’s ordinary shares resulting from the redomiciliation to Switzerland.

Since its inception in 2010, the Company has become a fully integrated global organization with nearly 12,000 employees worldwide.

Securities and Exchange Commission pursuant to Rule 424(b)(3) on March 10, 2025 for a full description of the changes related to the Company’s ordinary shares following the Continuation.

Since its inception in 2010, the Company has become a fully integrated global organization with over 12,000 employees worldwide.

Basis of presentation and consolidation

The accompanying condensed consolidated balance sheet as of September 30, 2025, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2025 and 2024, the condensed consolidated statements of cash flows for the nine months ended September 30, 2025 and 2024, and the condensed consolidated statements of shareholders’ equity for the three and nine months ended September 30, 2025 and 2024, and the related footnote disclosures are unaudited.

The accompanying condensed consolidated balance sheet as of March 31, 2026, the condensed consolidated statements of operations and comprehensive income for the three months ended March 31, 2026 and 2025, the condensed consolidated statements of cash flows for the three months ended March 31, 2026 and 2025, and the condensed consolidated statements of shareholders’ equity for the three months ended March 31, 2026 and 2025, and the related footnote disclosures are unaudited.

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

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

Results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the results expected for the full fiscal year or for any future annual or interim period.

Results of operations for the three months ended March 31, 2026 are not necessarily indicative of the results expected for the full fiscal year or for any future annual or interim period.

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

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

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

Areas where management uses subjective judgment include, but are not limited to, estimating the useful lives of long-lived assets, estimating variable consideration in product sales and collaboration revenue arrangements, assessing the impairment of long-lived assets, valuation and recognition of share-based compensation expenses, realizability of deferred tax assets, estimating uncertain tax positions, valuation of inventory, estimating the allowance for credit losses, determining defined benefit pension plan obligations, measurement of right-of-use assets and lease liabilities, estimates related to research and development accruals, estimates related to the sale of future royalty liability and the fair value of financial instruments.

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

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New accounting standards which have not yet been adopted

In September 2025, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40):

In December 2025, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2025-10, Government Grants (Topic 832):

Accounting for Government Grants Received by Business Entities (ASU 2025-10), which establishes authoritative guidance on the recognition, measurement, presentation, and disclosure of government grants.

Under ASU 2025-10, government grants are recognized when it is probable that the entity will both comply with the conditions of the grant and the grant will be received.

The ASU provides specific accounting models for grants related to assets and grants related to income, including options to recognize government grants as deferred income or as a reduction of the asset’s cost basis.

The ASU also requires enhanced disclosures regarding the nature of government grants, significant terms and conditions, accounting policies applied, and amounts recognized in the financial statements.

ASU 2025-10 is effective for fiscal years beginning after December 15, 2028, including interim periods within those fiscal years, with early adoption permitted.

The Company is currently evaluating the impact of adopting ASU 2025-10 on its consolidated financial statements and related disclosures.

In September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40):

Targeted Improvements to the Accounting for Internal-Use Software.

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

Significant accounting policies

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

There have been no material changes to the Company’s significant accounting policies as of and for the nine months ended September 30, 2025, as compared to the significant accounting policies described in the Annual Report, other than the accounting for the sale of future royalty liability disclosed in Note 4.

There have been no material changes to the Company’s significant accounting policies as of and for the three months ended March 31, 2026, 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, 2025 and December 31, 2024:

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, 2026 and December 31, 2025:

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

As of September 30, 2025 (Level 1) (Level 2) (Level 3)

As of March 31, 2026 (Level 1) (Level 2) (Level 3)

Cash equivalents

9 unchanged sentences

Money market funds 2,384,656 — —

Prepaid expenses and other current assets:

Convertible debt instrument — — 618

Other non-current assets (Note 5):

1 unchanged sentence

Convertible debt instrument — — 6,135

Other 1,271 — —

Total 2,385,927 2 6,135

1 unchanged sentence

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

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

(“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 5, 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 private biotech companies.

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) income, net.

The Company recorded net losses on fair value adjustment of $ 3,093 and $ 1,882 for the three and nine months ended September 30, 2025, respectively, and $ 1,802 and $ 1,664 for the three and nine months ended September 30, 2024, respectively.

As of September 30, 2025 and December 31, 2024, the fair values of cash and cash equivalents, restricted cash, accounts receivable, accounts payable, and short-term debt approximated their carrying values due to their short-term nature.

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 net gains on fair value adjustment of $ 79 and $ 1,136 for the three months ended March 31, 2026 and 2025, respectively.

As of March 31, 2026 and December 31, 2025, the Company held time deposits of $ 39,296 and nil , respectively, that were classified as cash equivalents.

As of March 31, 2026 and December 31, 2025, the fair values of cash and cash equivalents, restricted cash, accounts receivable, accounts payable, and short-term debt approximated their carrying values due to their short-term nature.

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

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For detailed descriptions of each arrangement, see the Company’s Annual Report.

For the three and nine months ended September 30, 2025, the Company’s other revenue consisted primarily of royalty revenue from IMDELLTRA ® sales outside of China under the Amgen collaboration agreement and revenue generated under the Novartis broad markets agreement.

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

See Note 4 for further discussions of the accounting for the sale of future royalties associated with IMDELLTRA ® to Royalty Pharma in the third quarter of 2025.

The Company will continue to recognize royalty revenue when such royalties are required to be paid by Amgen.

The following table summarizes total other revenue recognized for the three and nine months ended September 30, 2025 and 2024:

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

For the three months ended March 31, 2026 and 2025, the Company’s other revenue consisted primarily of royalty revenue from IMDELLTRA ® sales outside of China under the Amgen collaboration agreement and revenue generated under the Novartis broad markets agreement.

The following table summarizes total other revenue recognized for the three months ended March 31, 2026 and 2025:

Three Months Ended

Other Revenue $ $

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In-Licensing Arrangements - Commercial

During the three and nine months ended September 30, 2025 and 2024, the Company recorded the following amounts related to its collaboration arrangement with Amgen.

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

During the three months ended March 31, 2026 and 2025, the Company recorded the following amounts related to its collaboration arrangement with Amgen.

For a detailed description of the arrangement and related rights and obligations, see the Company’s Annual Report.

The Company is still in the commercialization period for XGEVA ® , KYPROLIS ® and BLINCYTO ® in China.

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, 2025 and 2024 were as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 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, 2026 and 2025 were as follows:

Three Months Ended

BeOne’s portion of the development funding 58,048 40,519

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Research and development expense 29,403 20,707

September 30, 2025

March 31, 2026

Remaining portion of development funding cap 72,346

As of September 30, 2025 and December 31, 2024, 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, 2026 and December 31, 2025, 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 35,700 64,345

Research and development cost share liability, non-current portion — 54,286

Total research and development cost share liability 35,700 64,345

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, 2025 and 2024 as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

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, 2026 and 2025 as follows:

Three Months Ended

Cost of sales - product 11,253 7,494

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

Inventory purchases amounted to $ 84,243 and $ 220,275 during the three and nine months ended September 30, 2025, respectively, and $ 43,061 and $ 152,940 during the three and nine months ended September 30, 2024, respectively.

Net amounts payable to Amgen was $ 116,413 and $ 116,563 as of September 30, 2025 and December 31, 2024, respectively.

Inventory purchases amounted to $ 123,691 and $ 62,744 during the three months ended March 31, 2026 and 2025, respectively.

Net amounts payable to Amgen was $ 135,273 and $ 79,097 as of March 31, 2026 and December 31, 2025, respectively.

In-Licensing Arrangements - Development

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

Upfront and milestone payments incurred under these arrangements for the three and nine months ended September 30, 2025 and 2024 are set forth below.

Upfront and milestone payments incurred under these arrangements for the three months ended March 31, 2026 and 2025 are set forth below.

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

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

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

Three Months Ended

Payments due to collaboration partners Classification $ $

Upfront payments Research and development expense 544 —

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

Regulatory and commercial milestone payments Intangible asset — — 20,000 —

Total 191 5,000 20,691 51,527

Sale of Future IMDELLTRA ® Royalties

On August 25, 2025, the Company entered into an agreement ("Royalty Agreement") to sell its royalty rights on the worldwide sales, excluding China, of Amgen’s IMDELLTRA ® (tarlatamab-dlle) for up to $ 950,000 to Royalty Pharma Investments 2023 ICAV (“Royalty Pharma”).

Under the terms of the Royalty Agreement, the Company received a non-refundable upfront payment of $ 885,000 , with the option to sell remaining royalties within one year for up to $ 65,000 .

On August 25, 2025, the Company entered into an agreement (the “Royalty Agreement”) to sell its royalty rights on the worldwide sales, excluding China, of Amgen’s IMDELLTRA ® (tarlatamab-dlle) for up to $ 950,000 to Royalty Pharma Investments 2023 ICAV (“Royalty Pharma”).

Under the terms of the Royalty Agreement, the Company received a non-refundable upfront payment of $ 885,000 upon closing of the Royalty Agreement.

Subsequently, the Company exercised its option to sell additional royalties to Royalty Pharma and received $ 26,000 in the fourth quarter of 2025.

The Company will share in a portion of the royalty on annual sales above $ 1.5 billion, and will maintain royalty and all other rights to other assets under the terms of its collaboration agreement with Amgen.

The Company evaluated the arrangement and determined that the proceeds from the sale of future IMDELLTRA ® royalties, as well as the option to sell remaining royalties when and if exercised, should be treated as a financing liability according to ASC 470, Debt due to the Company’s continuing involvement with the Amgen collaboration.

At the transaction date, the Company recognized the upfront proceeds received from Royalty Pharma of $ 885,000 as a liability and is amortizing it using the effective interest method over the life of the arrangement.

At the transaction date, the Company recognized the upfront proceeds received from Royalty Pharma of $ 885,000 and, subsequently, the option proceeds of $ 26,000 , as liabilities and is amortizing them using the effective interest method over the life of the arrangement.

The Company imputes interest expense associated with the liability using the effective interest rate method.

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The Royalty Agreement also contains customary representations, warranties, covenants, and indemnification provisions.

As of September 30, 2025, the royalty financing obligation recorded in the Company’s balance sheet was as follows:

September 30, 2025

As of March 31, 2026 and December 31, 2025, the royalty financing obligation recorded in the Company’s balance sheet was as follows:

March 31, December 31,

Sale of future royalty liability, current portion 72,735 56,714

1 unchanged sentence

Total sale of future royalty liability 904,399 906,956

The carrying value of the sale of future royalty liability approximates fair value as of September 30, 2025 and is based on the Company’s current estimates of future royalties expected to be paid to Royalty Pharma over the life of the royalty stream, which are considered Level 3 inputs.

The Company accrued $ 5,580 in interest expense related to this arrangement for the three and nine months ended September 30, 2025, respectively.

The effective annual imputed interest rate was 6.4 % as of September 30, 2025.

The Company accrued $ 11,303 in royalty revenue for the three months ended September 30, 2025, which will be paid to Royalty Pharma in the fourth quarter of 2025.

As of September 30, 2025, no payments have been made to Royalty Pharma.

The following table summarizes the royalty sale liability activity during the three months ended March 31, 2026:

Royalty Sale Liability

Balance at December 31, 2025

Debt portion of royalties recognized and settled to Royalty Pharma ( 2,557 )

Balance at March 31, 2026

The carrying value of the sale of future royalty liability approximates fair value as of March 31, 2026 and is based on the Company’s current estimates of future royalties expected to be paid to Royalty Pharma over the life of the royalty stream, which are considered Level 3 inputs.

Interest expense related to this arrangement was as follows:

Three Months Ended

Interest expense 18,496 —

As of March 31, 2026, $ 18,496 of interest expense was accrued.

The effective annual imputed interest rate was 8.2 % as of March 31, 2026.

Restricted Cash and Investments

2 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, 2025 and December 31, 2024 was as follows:

September 30, December 31,

Restricted cash as of March 31, 2026 and December 31, 2025 was as follows:

March 31, December 31,

Short-term restricted cash 40,839 41,284

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 offering prospectus as well as those disclosed in the Company’s proceeds management policy approved by the board of directors.

As of September 30, 2025, the Company had cash remaining related to the STAR Offering proceeds of $ 248,992 .

As of March 31, 2026, the Company had cash remaining related to the STAR Offering proceeds of $ 6,735 .

Investments in Equity Securities

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

September 30, December 31,

March 31, December 31,

Equity securities with readily determinable fair values 2 2

Fair value of Leap common stock 334 2,113

Fair value of Leap warrants — 168

Equity securities without readily determinable fair values 37,232 33,154

Pi Health, Inc.

40,798 40,798

34,057 48,157

Equity-method investments 1

1 unchanged sentence

Total 59,987 55,543

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

The Company measures the investment in the common stock and warrants at fair value, with changes in fair value recorded to other (expense) 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) income, net during the nine months ended September 30, 2024.

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

3 In the three and nine months ended September 30, 2025, the Company recognized an impairment loss of $ 15,552 within other (expense) income, net, resulting from a decline in the enterprise value related to a business acquisition of one of its investees.

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

The Company recognized an other-than-temporary impairment loss of $ 12,376 during the nine months ended September 30, 2025, within unrealized losses from equity-method investments.

The following table summarizes unrealized losses related to investments in equity securities recorded in other (expense) income, net for the three and nine months ended September 30, 2025 and 2024:

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

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

The following table summarizes unrealized gains and losses related to investments in equity securities recorded in other income, net for the three months ended March 31, 2026 and 2025:

Three Months Ended

Equity securities with readily determinable fair values

116 494 ( 1,947 ) ( 1,539 )

Equity securities without readily determinable fair values 54 —

1 unchanged sentence

( 5 ) ( 13,375 )

Inventories, Net

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

September 30, December 31,

Raw materials 178,639 170,584

Work in process 100,808 60,118

Finished goods 252,240 264,284

Total inventories, net 531,687 494,986

Property, Plant and Equipment, Net

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

September 30, December 31,

March 31, December 31,

Land 71,434 71,434

9 unchanged sentences

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

In the nine months ended September 30, 2025, $ 460,383 of assets were placed into service.

As of September 30, 2025, the Company had construction in progress of $ 92,890 related to the Hopewell facility, the majority of which will be put into service in 2026.

Depreciation expense was $ 35,730 and $ 97,198 for the three and nine months ended September 30, 2025, respectively, and $ 70,028 and $ 117,892 for the three and nine months ended September 30, 2024, respectively.

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

As of March 31, 2026, the Company had construction in progress of $ 89,148 related to the Hopewell facility, the majority of which will be put into service in 2026.

Depreciation expense for the three months ended March 31, 2026 and 2025 was as follows:

Three Months Ended

Depreciation expense 39,385 31,614

Intangible Assets

Intangible assets as of September 30, 2025 and December 31, 2024 are summarized as follows:

September 30, 2025 December 31, 2024

Intangible assets as of March 31, 2026 and December 31, 2025 are summarized as follows:

March 31, 2026 December 31, 2025

carrying Accumulated Intangible carrying Accumulated Intangible

10 unchanged sentences

Amortization expense was as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

Three Months Ended

Amortization expense - Cost of sales - product

1,537 1,186 8,459 3,546

Amortization expense - Selling, general and administrative

Total 1,759 1,190

As of September 30, 2025, estimated amortization expense for each of the five succeeding years and thereafter was as follows:

As of March 31, 2026, estimated amortization expense for each of the five succeeding years and thereafter was as follows:

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

7 unchanged sentences

Total 61,189 492 61,681

Income tax expense was $ 22,323 and $ 47,182 for the three and nine months ended September 30, 2025 and $ 23,046 and $ 45,255 for the three and nine months ended September 30, 2024, respectively.

The income tax expense for the three and nine months ended September 30, 2025 was primarily attributable to current Switzerland tax expense based on year to date earnings and current China tax expense due to certain non-deductible expenses, offset with a net U.S.

tax benefit mainly driven by changes to the Company’s estimate of U.S.

R&D credits to be taken for prior periods reflected as discrete items through Q3 2025.

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

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

Income tax expense was $ 31,858 and $ 19,630 for the three months ended March 31, 2026 and 2025, respectively.

The income tax expense for the three months ended March 31, 2026 and 2025 was primarily attributable to current U.S.

tax expense determined after other special tax deductions and research and development credits, current Switzerland tax expense based on year to date earnings 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, 2025, the Company will maintain a full valuation allowance against its net deferred tax assets.

As of September 30, 2025, the Company had gross unrecognized tax benefits of $ 22,003 .

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 $ 515 and $ 4,764 in the three and nine months ended September 30, 2025, primarily due to U.S.

After consideration of all positive and negative evidence, as of March 31, 2026, the Company will maintain a full valuation allowance against its net deferred tax assets.

As of March 31, 2026, the Company had gross unrecognized tax benefits of $ 28,495 .

Due to the uncertain and complex application of income tax regulations by certain tax authorities outside of the U.S., it is possible that the ultimate resolution of ongoing audits may result in liabilities that could be materially different from current estimates.

The ongoing audit resolutions, including Italy, China and Spain, for the tax years 2020 through 2024, could impact future tax expenses if tax authorities in their administration of tax laws during open audits may lead us to change our assessment of whether or not it is more likely than not that certain tax benefit positions will be sustained.

Accordingly, potential future settlements could be material, principally in China.

The Company’s reserve for uncertain tax positions increased by $ 660 in the three months ended March 31, 2026, primarily due to U.S.

federal and state tax credits and incentives .

Supplemental Balance Sheet Information

Prepaid expenses and other current assets consist of the following:

September 30, December 31,

Inventories, net consisted of the following:

March 31, December 31,

Raw materials 274,228 236,190

Work in process 109,209 122,681

Finished goods 298,153 249,356

Total 681,590 608,227

Prepaid expenses and other current assets consisted of the following:

March 31, December 31,

Short-term restricted cash 40,839 41,284

Prepaid research and development costs 36,126 52,594

Other receivables 39,098 32,828

Prepaid taxes 34,475 42,232

Prepaid general and administrative expenses 22,984 22,209

Short-term restricted cash 52,987 9,312

Prepaid manufacturing cost 2,675 19,333

Other current assets 45,226 32,652

Other receivables 10,345 21,781

Total 189,995 212,752

Other non-current assets consist of the following:

September 30, December 31,

Other non-current assets consisted of the following:

March 31, December 31,

Long-term investments 65,985 61,678

5 unchanged sentences

Total 104,243 102,418

Accrued expenses and other payables consist of the following:

September 30, December 31,

Accrued expenses and other payables consisted of the following:

March 31, December 31,

Revenue rebates and returns related 440,437 398,533

External research and development activities related 199,380 156,525

Compensation related 156,930 305,055

Commercial activities 123,249 118,449

External research and development activities related 125,087 154,269

Individual income tax and other taxes 80,910 60,359

2 unchanged sentences

Total 1,079,283 1,109,120

Other long-term liabilities consist of the following:

September 30, December 31,

Other long-term liabilities consisted of the following:

March 31, December 31,

Deferred government grant income 28,724 28,979

3 unchanged sentences

Total 81,952 80,245

The following table summarizes the Company’s short-term and long-term debt obligations as of September 30, 2025 and December 31, 2024:

Facilities Agreement

In November 2025, BeOne Medicines Ltd.

entered into the Facilities Agreement (the “Facilities Agreement”), by and among certain subsidiaries of the Company, as guarantors, the Hongkong and Shanghai Banking Corporation Limited (“HSBC”), as global coordinator, original mandated lead arranger and bookrunner, agent and security agent, and certain financial institutions listed in the Facilities Agreement, as lenders.

The Facilities Agreement provides for a $ 140,000 U.S.

dollar-denominated, 2-year B1 revolving credit facility (the “B1 Revolving Loan Facility”), a $ 560,000 U.S.

dollar-denominated, 2-year , B2 term loan facility (the “B2 Term Loan Facility” and, together with the B1 Revolving Loan Facility, the “B Loan Facilities”), and a RMB 2,150,000 Renminbi-denominated, 3-year , A term loan facility (the “A Loan Facility”) (collectively, the “Loan Facilities”).

The following table presents outstanding borrowings under the Facilities Agreement:

March 31, December 31,

A Loan Facility 12,467 12,298

unamortized debt issuance costs ( 3,211 ) ( 3,235 )

Total short-term debt 9,256 9,063

A Loan Facility 299,218 295,152

B2 Term Loan Facility 560,000 560,000

unamortized debt issuance costs ( 16,298 ) ( 18,783 )

Total long-term debt 842,920 836,369

The A Loan Facility requires repayment of 4 % of the aggregate amount outstanding every six months beginning on November 24, 2026, with all remaining principal outstanding due on November 24, 2028.

The B2 Term Loan Facility requires repayment of 10 % of the aggregate amount outstanding every three months beginning on June 15, 2027, with all remaining principal outstanding due on December 15, 2027, unless the final repayment date is extended.

The Company may voluntarily prepay borrowings, in whole or in part, under the Facilities Agreement without premium or penalty.

The Facilities Agreement also contains certain customary mandatory prepayment provisions in the event that the Company undergoes a change of control and in relation to disposal and insurance proceeds.

The A Loan Facility is subject to an interest rate equal to the Reference Rate (RMB) (as defined in the Facilities Agreement) plus a margin of 0.65 % per annum.

The B Loan Facilities are subject to an interest rate equal to the Reference Rate (USD) (as defined in the Facilities Agreement) plus a margin of 2.40 % per annum.

In addition to paying interest on the outstanding principal, the Company is also required to pay a commitment fee of 0.85 % on the undrawn and uncancelled amounts under the Loan Facilities.

Excluding commitment fees, the interest rate for the A Loan Facility and B2 Term Loan Facility was 3.7 % and 6.1 %, respectively, as of March 31, 2026.

As of March 31, 2026, the B1 Revolving Loan Facility was available for borrowing.

Subject to certain limitations, the Loan Facilities are secured on a first priority basis granted in favor of HSBC (as security agent on behalf of the secured parties) by:

(a) a security interest in the equity interests of a member of the Company and its subsidiaries and (b) security interests in, and mortgage on, the Company’s manufacturing and clinical R&D facility in New Jersey.

The Company is required to satisfy certain financial and non-financial covenants under the Facilities Agreement.

The Company was compliant with the required covenants as of March 31, 2026.

Other Bank Loans

The following table summarizes the Company’s working capital and project loans as of March 31, 2026 and December 31, 2025:

Lender Borrower Term Maturity Date Note As of

September 30, 2025 December 31, 2024

March 31, 2026 December 31, 2025

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

6 unchanged sentences

July 28, 2032 4 9,423 9,294

China Merchants Bank BeOne Medicines Ltd.

January 21, 2026 5 380,000 380,000

China Minsheng Bank BeOne Medicines Ltd.

December 16, 2025 6 150,000 150,000

China Industrial Bank BeOne Medicines USA, Inc.

June 28, 2026 7 94,817 —

China Industrial Bank BeOne Medicines Ltd.

March 27, 2025 8 — 92,475

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

June 5, 2025 9 — 54,800

HSBC Bank BeOne Medicines Ltd.

June 17, 2026 10 47,760 46,580

Shanghai Pudong Development Bank BeOne Medicines Ltd.

November 24, 2025 11 95,448 93,091

March 18, 2027 5 57,989 —

Total short-term debt 106,884 48,230

9 unchanged sentences

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

The loan interest rate was 3.8 % as of September 30, 2025.

The loan interest rate was 3.8 % as of March 31, 2026.

The outstanding principal balance is payable in semi-annual installments.

The Company repaid $ 8,358 (RMB 60,000 ) during the nine months ended September 30, 2025.

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

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

The loan interest rate was 3.4 % as of September 30, 2025.

The loan interest rate was 3.4 % as of March 31, 2026.

The outstanding principal balance is payable in quarterly installments.

The Company repaid $ 6,512 (RMB 47,143 ) during the nine months ended September 30, 2025.

The Company repaid $ 2,262 (RMB 15,715 ) during the three months ended March 31, 2026.

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

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

The loan interest rate was 3.2 % as of September 30, 2025.

The loan interest rate was 3.2 % as of March 31, 2026.

The outstanding principal balance is payable in quarterly installments.

The Company repaid $ 6,192 (RMB 44,620 ) during the nine months ended September 30, 2025.

The Company repaid $ 2,155 (RMB 14,855 ) during the three months ended March 31, 2026.

The loan is secured by fixed assets placed into service in the third phase of the Guangzhou manufacturing facility’s buildout.

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

The loan interest rate was 3.3 % as of September 30, 2025.

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

The loan interest rate was 3.3 % as of March 31, 2026.

The outstanding principal balance is payable in semi-annual installments.

The Company repaid $ 3,224 (RMB 22,400 ) during the three months ended March 31, 2026.

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

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

The loan interest rate was 6.2 % as of September 30, 2025.

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

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

The loan interest rate was 6.8 % as of September 30, 2025.

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

The loan interest rate was 3.0 % as of September 30, 2025.

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

The Company repaid the principal during the nine months ended September 30, 2025.

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

The Company repaid the principal during the nine months ended September 30, 2025.

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

The loan interest rate was 3.6 % as of September 30, 2025.

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

The loan interest rate was 2.9 % as of September 30, 2025.

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

5 In March 2026, the Company entered into a credit facility agreement with China Merchants Bank for an aggregate facility of RMB 950,000 , denominated in RMB, available for a period of 30 months for drawdown as revolving and/or one-time borrowings.

The Company drew down $ 58,204 (RMB 400,000 ) during the three months ended March 31, 2026.

The borrowing bears floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC.

The loan interest was 2.6 % as of March 31, 2026.

The Company has numerous financial and non-financial covenants on its debt obligations with the lenders above.

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

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

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

As of September 30, 2025, the Company was in compliance with all covenants of its material debt agreements.

As of March 31, 2026, 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, 2025 was $ 12,650 and $ 37,659 , respectively, among which, $ 1,886 and $ 11,899 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 paid for the nine months ended September 30, 2025 and 2024, net of amounts capitalized, amounted to $ 24,249 and $ 12,466 , respectively.

Interest expense related to bank loans was as follows:

Three Months Ended

Interest expense, excluding amortization of debt issuance costs

15,567 12,961

Amortization of debt issuance costs 2,600 —

Capitalized interest expense

Product Revenue

2 unchanged sentences

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

The table below presents the Company’s net product revenue for the three and nine months ended September 30, 2025 and 2024.

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

The table below presents the Company’s net product revenue for the three months ended March 31, 2026 and 2025:

Three Months Ended

Product revenue – gross 1,893,489 1,400,066

1 unchanged sentence

Product revenue – net 1,487,329 1,108,530

The following table disaggregates net product revenue by product for the three and nine months ended September 30, 2025 and 2024:

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

The following table disaggregates net product revenue by product for the three months ended March 31, 2026 and 2025:

Three Months Ended

1,094,843 791,664

6 unchanged sentences

Total product revenue – net 1,487,329 1,108,530

The following table presents the roll-forward of accrued revenue rebates and returns for the nine months ended September 30, 2025 and 2024:

The following table presents the roll-forward of accrued revenue rebates and returns for the three months ended March 31, 2026 and 2025:

Rebates, Returns and Other Deductions Contra AR Accruals Total

Balance at December 31, 2025

398,533 79,126 477,659

Accrual 198,270 207,890 406,160

Payments ( 156,366 ) ( 225,344 ) ( 381,710 )

Balance at September 30, 2025 382,777 51,088 433,865

Balance at March 31, 2026

440,437 61,672 502,109

Balance at December 31, 2024

235,600 50,699 286,299

Accrual 130,027 161,509 291,536

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

Balance at September 30, 2024 213,747 35,232 248,979

Earnings (Loss) Per Share/ADS

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

Three Months Ended Nine Months Ended

September 30, September 30,

Balance at March 31, 2025

259,944 35,158 295,102

Net income (loss) 124,841 ( 121,350 ) 220,431 ( 492,905 )

Earnings Per Share/ADS

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

Three Months Ended

Net income 227,357 1,270

Weighted-average shares outstanding—basic 1,442,451,870 1,390,052,966

2 unchanged sentences

Antidilutive common share equivalents excluded from above 511,433 1,408,376

Earnings (loss) per share:

Earnings per share:

Basic 0.16 0.00

Diluted 0.15 0.00

Earnings (loss) per ADS:

Earnings per ADS:

Basic 2.05 0.01

Diluted 1.96 0.01

For the three and nine months ended September 30, 2025, diluted earnings per share was computed using the weighted-average number of ordinary shares and the effect of potentially dilutive shares outstanding during the periods.

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

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

For the three and nine months ended September 30, 2024, the Company was in a net loss position and the effects of all share options, restricted share units and ESPP shares were excluded from the calculation of diluted loss per share, as their effect would have been anti-dilutive.

For the three months ended March 31, 2026 and 2025, diluted earnings per share was computed using the weighted-average number of ordinary shares and the effect of potentially dilutive shares outstanding during the periods.

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

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

Each ADS represents 13 ordinary shares.

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

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

Share-Based Compensation Expense

Share Option, Restricted Share Units and Performance Share Units

During the nine months ended September 30, 2025, the Company granted options for 2,527,499 ordinary shares, restricted share units for 27,902,628 ordinary shares, and performance share units for 1,876,056 ordinary shares under the Company’s share option and incentive plan.

As of September 30, 2025, options, restricted share units, and performance share units for ordinary shares outstanding totaled 50,032,205 , 78,985,556 , and 3,934,632 , respectively.

As of September 30, 2025, share-based awards to acquire 59,929,336 ordinary shares were available for future grant under the Company’s share option and incentive plan.

During the three months ended March 31, 2026, the Company granted restricted share units for 778,817 ordinary shares under the Company’s share option and incentive plan.

As of March 31, 2026, options, restricted share units, and performance share units for ordinary shares outstanding totaled 47,017,959 , 74,129,393 , and 4,551,157 , respectively.

As of March 31, 2026, share-based awards to acquire 61,363,925 ordinary shares were available for future grant under the Company’s share option and incentive plan.

Employee Share Purchase Plan

1 unchanged sentence

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

As of September 30, 2025, 3,179,780 ordinary shares were available for future issuance under the ESPP.

As of March 31, 2026, 2,438,481 ordinary shares were available for future issuance under the ESPP.

The following table summarizes the shares issued under the ESPP:

2 unchanged sentences

Issuance Date ADS Ordinary ADS Ordinary Proceeds

August 31, 2025 818,506 $ 245.53 $ 18.89 $ 208.70 $ 16.05 $ 13,140

February 28, 2026 741,299 $ 316.99 $ 24.38 $ 269.44 $ 20.73 $ 15,364

4 unchanged sentences

Share-Based Compensation Expense

The following table summarizes total share-based compensation expense recognized for the three and nine months ended September 30, 2025 and 2024:

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

The following table summarizes total share-based compensation expense recognized for the three months ended March 31, 2026 and 2025:

Three Months Ended

Research and development 53,856 41,767

3 unchanged sentences

The movement of accumulated other comprehensive loss was as follows:

Foreign Currency Pension

Translation Liability

Foreign Currency

Translation Other

Adjustments Adjustments Total

3 unchanged sentences

Net-current period other comprehensive income 24,470 232 24,702

Balance as of September 30, 2025 ( 88,506 ) ( 12,751 ) ( 101,257 )

Balance as of March 31, 2026 ( 41,782 ) ( 11,700 ) ( 53,482 )

Restricted Net Assets

8 unchanged sentences

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

As of September 30, 2025 and December 31, 2024, amounts restricted were the net assets of the Company’s PRC subsidiaries, which, after intercompany eliminations, amounted to $ 1,915,887 and $ 1,709,961 , respectively.

As of March 31, 2026 and December 31, 2025, amounts restricted were the net assets of the Company’s PRC subsidiaries, which, after intercompany eliminations, amounted to $ 2,149,922 and $ 2,012,019 , respectively.

Commitments and Contingencies

Purchase Commitments

As of September 30, 2025, the Company had non-cancellable purchase commitments amounting to $ 175,115 , of which $ 24,921 related to non-utilization fees and minimum purchase requirements for supply purchased from contract manufacturers and $ 150,194 related to binding purchase obligations of inventory from Amgen.

As of March 31, 2026, the Company had non-cancellable purchase commitments amounting to $ 186,437 , of which $ 22,579 related to non-utilization fees and minimum purchase requirements for supply purchased from contract manufacturers and $ 163,858 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 $ 52,061 for the acquisition of property, plant and equipment as of September 30, 2025, related to various facilities across the globe, including the manufacturing and clinical R&D facility in Hopewell, New Jersey.

The Company had capital commitments amounting to $ 22,925 for the acquisition of property, plant and equipment as of March 31, 2026, related to various facilities across the globe.

Co-Development Funding Commitment

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

As of September 30, 2025, the Company’s remaining co-development funding commitment was $ 183,592 .

As of March 31, 2026, the Company’s remaining co-development funding commitment was $ 72,346 .

Funding Commitment

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

As of September 30, 2025, the remaining capital commitment was $ 5,991 and is expected to be paid from time to time over the investment period.

As of March 31, 2026, the remaining capital commitment was $ 4,406 and is expected to be paid from time to time over the investment period.

Segment and Geographic Information

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

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

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

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

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

Significant segment expenses reviewed by the CODM on a regular basis included within net income include cost of product sales, research and development expenses and selling, general and administrative expenses which are separately presented on the Company’s consolidated statements of operations.

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

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

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Total revenues by geographic area are presented as follows:

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

Three Months Ended

- total revenue 782,255 567,211

11 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