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Item 7. Management’s Discussion and Analysis

2026-02-26 compared with 2025-02-27 · 209 added, 131 removed, 223 unchanged (60% of the section changed)

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We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this report, including those set forth under “Part I—Item 1A—Risk Factors” and under “Forward‑Looking Statements and Market Data” in this Annual Report.

A discussion of the Company’s financial condition and results of operations for the year ended December 31, 2023 and year-to-year comparisons between 2024 and 2023 can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

Non-GAAP Financial Measures

We provide certain financial measures that are not defined under accounting principals generally accepted in the United States of America (“GAAP”), commonly referred to as non-GAAP financial measures, including Adjusted Operating Expenses and Adjusted Income (Loss) from Operations and certain other non-GAAP measures, each of which include adjustments to GAAP figures.

We provide certain financial measures that are not defined under accounting principles generally accepted in the United States of America (“GAAP”), commonly referred to as non-GAAP financial measures, including Adjusted Operating Expenses, Adjusted Income (Loss) from Operations, Adjusted Net Income (Loss), Adjusted Earnings Per Share, Free Cash Flow and certain other non-GAAP measures, each of which include adjustments to GAAP figures.

These non-GAAP measures are intended to provide additional information on our operating performance.

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Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred.

Non-GAAP adjustments are tax effected to the extent there is US GAAP current tax effect.

The Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects in our tax expense.

We maintain an established non-GAAP policy that guides the determination of what items may be excluded in non-GAAP financial measures.

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The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of our historical and expected financial results and trends and to facilitate comparisons between periods and with respect to projected information.

In addition, these non-GAAP financial measures are among the indicators BeiGene’s management uses for planning and forecasting purposes and measuring our performance.

In addition, these non-GAAP financial measures are among the indicators BeOne’s management uses for planning and forecasting purposes and measuring our performance.

These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, GAAP financial measures.

The non-GAAP financial measures used by BeiGene may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies.

Our fourth quarter and full year results demonstrate our tremendous growth as a global oncology powerhouse, reinforced by the continued success of BRUKINSA and the development of one of the most prolific solid tumor pipelines in oncology with multiple data readouts expected in 2025.

BRUKINSA is now the unequivocal leader in new CLL patient starts in the U.S., holds the broadest label of any BTK inhibitor and serves as the cornerstone of our hematology franchise, showing immense promise as a backbone alongside our late stage BCL2 inhibitor, sonrotoclax, and our potential first-in-class BTK CDAC.

We are also building future solid tumor franchises in breast, lung, and gastrointestinal cancers by leveraging our platforms in multi-specific antibodies, protein degraders and antibody-drug conjugates.

2025 marks an inflection point as we anticipate achieving positive GAAP operating income and operating cash flow alongside our intention to change our name to BeOne with our new NASDAQ ticker, ONC.

The non-GAAP financial measures used by BeOne may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies.

Our fourth quarter and full year results show topline growth and a strong liquidity position to support ongoing operations and strategic priorities.

BRUKINSA is the global revenue leader in the BTK inhibitor class and TEVIMBRA continues to gain new indications and expanded reimbursement in multiple markets.

Our late-stage hematology assets are approaching commercialization and our solid tumor portfolio continues to deliver encouraging data.

Key highlights for the full year 2025 are as follows:

• Total global revenues of $1.5 billion and $5.3 billion, respectively, in the fourth quarter and full year, increases of 32.8% and 40.2%, respectively, compared to the prior year periods;

• Narrowed GAAP operating loss and achieved full-year positive non-GAAP operating income

• Global BRUKINSA revenues of $828.0 million and $2.6 billion for the fourth quarter and full year 2024, increases of 100.5% and 104.9%, respectively, compared to the prior year periods;

• Progressed pivotal-stage programs for BCL2 inhibitor sonrotoclax and BTK CDAC BGB-16673;

• Advanced six and thirteen NMEs into the clinic in the fourth quarter and full year, respectively;

• Anticipate multiple data readouts for innovative solid tumor programs in 1H 2025.

• Global BRUKINSA revenues of $1.1 billion and $3.9 billion for the fourth quarter and full year 2025, increases of 38.4% and 48.6%, respectively, compared to the prior year periods;

• GAAP diluted earnings per American Depositary Share (“ADS”) of $0.58 and $2.53 for the fourth quarter and full year, non-GAAP diluted earnings per ADS of $1.95 and $8.09 for the fourth quarter and full year.

Recent Business Developments

On January 13, 2025 we participated in the 43 rd Annual J.P.

Morgan Healthcare Conference and announced that we expect to achieve positive operating income for full year 2025 pursuant to generally accepted accounting principles.

On December 27, 2024, we announced that the U.S.

Food and Drug Administration (“FDA”) approved TEVIMBRA ® (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 (≥1).

On December 23, 2024, we announced that our American Depository Shares will begin trading on the Nasdaq Global Select Market under our new ticker symbols “ONC” as of January 2, 2025.

On December 12, 2024, we announced entering into a global licensing agreement with CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.

for SYH2039, a novel methionine adenosyltransferase 2A (MAT2A)-inhibitor being explored for solid tumors.

On November 27, 2024, we announced that the European Commission approved TEVIMBRA ® in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma.

On November 19, 2024, we announced entering into a settlement agreement with MSN Pharmaceuticals, Inc.

and MSN Laboratories Private Ltd.

resolving patent litigation related to MSN’s Abbreviated New Drug Application seeking approval to market a generic version of BRUKINSA ® (zanubrutinib) in the U.S.

On November 14, 2024, we announced our intention to change the Company’s name to “BeOne Medicines Ltd.” confirming our commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible.

Implementation of our new name is subject to shareholder approval to be sought at a future shareholder meeting.

On December 7, 2025, we announced new data on sonrotoclax, a next-generation investigational BCL2 inhibitor, demonstrating meaningful clinical benefit as monotherapy and in combination across B-cell malignancies, and in January 2026, we received the first approval of sonrotoclax for adult patients with relapsed/refractory (“R/R”) mantle cell lymphoma (“MCL”) and R/R chronic lymphocytic leukemia (“CLL”)/small lymphocytic lymphoma (“SLL”).

On November 26, 2025, we announced that the U.S.

Food and Drug Administration (“FDA”) accepted and granted Priority Review to a New Drug Application (“NDA”) for sonrotoclax for the treatment of adult patients with R/R MCL, following treatment with a Bruton’s tyrosine kinase (“BTK”) inhibitor.

On November 17, 2025, we announced positive top-line results from the Phase 3 HERIZON-GEA-01 trial evaluating ZIIHERA ® (zanidatamab), a HER2-targeted bispecific antibody, in combination with chemotherapy, with or without PD-1 inhibitor TEVIMBRA ® (tislelizumab), as first-line treatment for HER2-positive (“HER2+”) locally advanced or metastatic gastroesophageal adenocarcinoma (“GEA”), including cancers of the stomach, gastroesophageal junction, and esophagus.

On November 13, 2025, we entered into the Facilities Agreement (the “Facilities Agreement”) with The Hongkong and Shanghai Banking Corporation Limited (“HSBC”) and certain financial institutions listed in the Facilities Agreement as lenders.

The Facilities Agreement provides senior secured financing consisting of a U.S.

dollar-denominated, B1 revolving loan facility in an aggregate principal amount of $140 million (the “B1 Revolving Loan Facility”), a U.S.

dollar-denominated, B2 term loan facility in an aggregate principal amount of $560 million (the “B2 Term Loan Facility” and, together with the B1 Revolving Loan Facility, the “B Loan Facilities”);

and a Renminbi-denominated, A term loan facility in an aggregate principal amount of approximately $300 million (the “A Loan Facility”) (collectively, the “Loan Facilities”).

The A Loan Facility matures 36 months after the first utilization date of such facility and, unless extended, the B Loan Facilities mature 24 months after the first utilization date of a B Loan Facility.

Subject to certain limitations, the Loan Facilities are secured on a first priority basis granted in favor of HSBC by a security interest in the equity interests of a number of our subsidiaries and security interests in, and mortgage on, our manufacturing and clinical R&D facility in New Jersey.

The Facilities Agreement contains certain affirmative and negative covenants, as well as financing covenants applicable to the Loan Facilities.

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.

Subsequently, on December 16, 2025, we utilized a portion of the proceeds from borrowings under the Facilities Agreement to repay in full all outstanding amounts owed under the Company’s Facility Agreement, dated as of December 9, 2024, by and between the Company and China Merchants Bank Co., Ltd.

(the “CMB Credit Facility”), and terminated all commitments by the lender to extend further credit under the CMB Credit Facility and all guarantees and security interests granted by the Company to the lender under the CMB Credit Facility.

On August 25, 2025, BeOne Medicines Ltd.

entered into a Royalty Purchase Agreement (the “Royalty Agreement”) with Royalty Pharma plc (“Royalty Pharma”), pursuant to which we agreed to sell a significant portion of our rights to royalty payments from Amgen based on annual net revenue from sales outside of China of any and all products that consist of Amgen’s IMDELLTRA ® .

Under the terms of the Royalty Agreement, we received a non-refundable upfront payment of $885 million upon the closing of the Royalty Agreement, and subsequently exercised our option to sell to Royalty Pharma an additional portion of our rights to royalty payments for approximately $26 million.

We will share in a portion of the royalties on annual ex-China net revenue from IMDELLTRA ® above $1.5 billion, and will maintain royalty and all other rights to other assets under the terms of the existing collaboration with Amgen, including xaluritamig, a first-in-class STEAP1 x CD3 XmAb currently being studied in patients with metastatic castration-resistant prostate cancer (mCRPC).

The upfront payment received from Royalty Pharma is classified as a financing liability according to ASC 470, Debt .

The repayment of this obligation to Royalty Pharma will be made upon the receipt of royalties from Amgen throughout the royalty period, which is anticipated to extend at least through 2041.

Results of Operations

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Product revenue, net $ 5,282,061 $ 3,779,546 $ 1,502,515 39.8 %

Collaboration revenue 30,695 268,927 (238,232) (88.6) %

Other revenue 60,972 30,695 30,277 98.6 %

Total revenues 5,343,033 3,810,241 1,532,792 40.2 %

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Total operating expenses 4,227,357 3,784,351 443,006 11.7 %

Loss from operations (568,199) (1,207,736) 639,537 (53.0) %

Interest income, net 47,836 74,009 (26,173) (35.4) %

Other (expense) income, net (12,638) 307,891 (320,529) (104.1) %

Loss before income tax expense (533,001) (825,836) 292,835 (35.5) %

Income (loss) from operations 447,136 (568,199) 1,015,335 (178.7) %

Interest income 70,505 69,641 864 1.2 %

Interest expense (58,234) (21,805) (36,429) 167.1 %

Other expense, net (42,553) (12,638) (29,915) 236.7 %

Income (loss) before income tax expense 416,854 (533,001) 949,855 (178.2) %

Income tax expense 129,921 111,785 18,136 16.2 %

Net loss $ (644,786) $ (881,708) $ 236,922 (26.9) %

Total revenue increased by $1.4 billion to $3.8 billion for the year ended December 31, 2024, from $2.5 billion for the year ended December 31, 2023, primarily due to increased sales of BRUKINSA, as well as increased sales of in-licensed products from Amgen and tislelizumab.

Collaboration revenue decreased year over year due to the recognition of the remaining deferred revenue associated with the Novartis collaborations upon termination of the agreements in 2023.

Total revenue by geographic area is presented as follows (amounts in thousands of U.S.

Year Ended December 31,

2024 % 2023 %

United States total revenue $ 1,957,498 51.4 % $ 1,128,219 45.9 %

Product revenue 1,950,530 51.2 % 945,551 38.5 %

Collaboration revenue 6,968 0.2 % 182,668 7.4 %

China total revenue 1,411,307 37.0 % 1,101,951 44.8 %

Product revenue 1,390,699 36.5 % 1,093,091 44.5 %

Collaboration revenue 20,608 0.5 % 8,860 0.3 %

Europe total revenue 362,626 9.5 % 202,014 8.2 %

Product revenue 359,507 9.4 % 122,228 5.0 %

Collaboration revenue 3,119 0.1 % 79,786 3.2 %

ROW total revenue 78,810 2.1 % 26,595 1.1 %

Product revenue 78,810 2.1 % 28,982 1.2 %

Collaboration revenue — — % (2,387) (0.1) %

Total Revenue 3,810,241 100.0 % 2,458,779 100.0 %

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

Net income (loss) $ 286,933 $ (644,786) $ 931,719 (144.5) %

Total revenue increased by $1.5 billion to $5.3 billion for the year ended December 31, 2025, from $3.8 billion for the year ended December 31, 2024, primarily due to increased sales of BRUKINSA, TEVIMBRA, as well as increased sales of in-licensed products from Amgen.

Net product revenue consisted of the following:

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$ 3,928,489 $ 2,644,226 $ 1,284,263 48.6 %

Tislelizumab 620,836 536,620 84,216 15.7 %

737,304 620,836 116,468 18.8 %

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Total product revenue $ 5,282,061 $ 3,779,546 $ 1,502,515 39.8 %

Net product revenue was $3.8 billion for the year ended December 31, 2024, compared to $2.2 billion in the prior year, primarily due to increased sales of BRUKINSA globally, driven by significant growth in the U.S.

In addition, product revenues in 2024 were positively impacted by growth from in-licensed products from Amgen and tislelizumab.

Net product revenue increased for the year ended December 31, 2025, compared to the prior year, primarily due to increased sales of BRUKINSA globally, driven by significant growth in the U.S.

In addition, product revenues in 2025 were positively impacted by growth from in-licensed products from Amgen and TEVIMBRA.

Global sales of BRUKINSA totaled $3.9 billion for the year ended December 31, 2025, representing a 48.6% increase compared to the prior year.

sales of BRUKINSA totaled $2.0 billion for the year ended December 31, 2024 compared to $945.6 million in the prior year, representing growth of 106.3%.

volume growth continued to accelerate in the period due primarily to demand growth coming from expanded use in CLL as BRUKINSA continued to gain share in new patient starts in CLL and all other approved indications.

In addition, U.S.

sales were also positively impacted in the fourth quarter of 2024 by seasonality and the timing of customer order patterns of approximately $30.0 million.

BRUKINSA sales in the EU totaled $358.8 million for the year ended December 31, 2024, representing growth of 193.6% compared to the prior-year period, driven by continued gains in market share across all major markets.

sales of BRUKINSA totaled $2.8 billion for the year ended December 31, 2025 compared to $2.0 billion in the prior year, representing growth of 45.1%, driven primarily by robust demand growth across all indications and modest benefit due to net pricing.

BRUKINSA continues to maintain its leading new patient share across the BTKi class due to its differentiated, best-in-class clinical profile.

BRUKINSA sales in the EU totaled $596.4 million for the year ended December 31, 2025, representing growth of 66.2% compared to the prior-year period, driven by continued gains in market share across all major markets, including Germany, Italy, Spain, France and the UK.

BRUKINSA sales in China totaled $344.1 million for the year ended December 31, 2025, representing growth of 33.3% compared to the prior year.

Sales of tislelizumab totaled $620.8 million for the year ended December 31, 2024, representing a 15.7% increase compared to the prior year.

Certain additional tislelizumab indications have been included in the 2025 NRDL.

There were no price reductions resulting from inclusion.

Collaboration revenue totaled $30.7 million for the year ended December 31, 2024, primarily related to revenue generated under the Novartis broad markets marketing and promotion agreement and royalty revenue under the Amgen collaboration.

Collaboration revenue totaled $268.9 million for the year ended December 31, 2023, primarily related to the recognition of the remaining deferred revenue associated with the former Novartis tislelizumab and ociperlimab collaborations which were terminated in the prior year.

Gross margin on global product sales increased to $3.2 billion, or 84.3% as a percentage of sales, for the year ended December 31, 2024, compared to $1.8 billion, or 82.7% as a percentage of sales, for the year ended December 31, 2023, primarily due to proportionately higher sales mix of BRUKINSA compared to other products in our portfolio, partially offset by the impact of accelerated depreciation expense of $32.7 million resulting from the move to more efficient, larger scale production lines for tislelizumab.

On an adjusted basis, which does not include the accelerated depreciation, gross margin as a percentage of product sales increased to 85.5% for the year ended December 31, 2024, from 83.2% in the comparable period of the prior year.

Sales of TEVIMBRA totaled $737.3 million for the year ended December 31, 2025, representing a 18.8% increase compared to the prior year.

Other revenue totaled $61.0 million and $30.7 million for the years ended December 31, 2025 and 2024, respectively, primarily related to royalty revenue under the Amgen collaboration and revenue generated under the Novartis broad markets marketing and promotion agreement.

Gross margin on global product sales increased to $4.6 billion, or 87.3% as a percentage of sales, for the year ended December 31, 2025, compared to $3.2 billion, or 84.3% as a percentage of sales, for the year ended December 31, 2024.

The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in our portfolio.

Gross margin also benefited from production productivity improvements resulting in lower costs for both BRUKINSA and TEVIMBRA.

These increases were slightly offset by period costs of $33.9 million related to the re-positioning of our manufacturing capacity during 2025.

On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 87.8% for the year ended December 31, 2025, from 85.5% in the prior year.

Research and Development Expense

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Refer to Non-GAAP Financial Measures and Non-GAAP Reconciliation in this MD&A for more information about, and a detailed reconciliation of, these items.

The increase in external research and development expenses for the year ended December 31, 2024 was primarily attributable to higher upfront license and development milestone fees and increases in Amgen co-development expense, partially offset by lower external clinical trial costs.

The increase in external research and development expenses for the year ended December 31, 2025 was primarily attributable to an increase in external costs of development programs primarily due to advancing preclinical programs into the clinic and early clinical programs into late stage, including sonrotoclax (BCL2i), as well as higher Amgen co-development expenses offset by lower development upfront and milestone fees.

Internal research and development expense increased $62.5 million, or 5.1%, to $1.3 billion for the year ended December 31, 2025 from $1.2 billion in the prior year, and was primarily attributable to the expansion of our global development organization and our clinical and preclinical drug candidates, as well as our continued efforts to internalize research and clinical trial activities.

Included within internal research and development expenses for the year ended December 31, 2024 is $27.1 million of accelerated depreciation expense related to the move of clinical production to larger, more efficient production lines.

Selling, General and Administrative Expense

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Selling, general and administrative expense increased by $250.4 million, or 13.7%, to $2.1 billion for the year ended December 31, 2025, from $1.8 billion for the year ended December 31, 2024.

The increase was due to continued investment in the global commercial launch of BRUKINSA primarily in the U.S.

The increase was primarily attributable to continued investment in global commercial expansion primarily in the U.S.

Selling, general and administrative expenses as a percentage of product sales were 39.4% for the year ended December 31, 2025 compared to 48.4% in the prior-year period.

We expect continued investment growth in selling and marketing expenses as our product sales increase.

Interest Income, Net

Interest income, net decreased by $26.2 million, or 35.4%, to $47.8 million for the year ended December 31, 2024, compared to $74.0 million for the year ended December 31, 2023.

The decrease in interest income was primarily attributable to lower interest rates earned on our cash and cash equivalents and lower cash balances in interest-bearing investments.

Interest expense increased resulting from a higher debt balance, partially offset by an increase in interest capitalization related to Hopewell construction.

Other (Expense) Income, Net

Interest Income

Interest income increased by $0.9 million, or 1.2%, to $70.5 million for the year ended December 31, 2025, compared to $69.6 million for the year ended December 31, 2024.

Interest income remained materially consistent, due to lower interest rates earned on our cash and cash equivalents offset by a higher cash and cash equivalents balance.

Interest Expense

Interest expense increased by $36.4 million, or 167.1%, to $58.2 million for the year ended December 31, 2025, compared to $21.8 million for the year ended December 31, 2024.

Interest expense increased resulting from interest expense recorded under the effective interest method related to the sale of future royalty liability, higher interest rates on debt balances and lower interest capitalized related to completion of certain phases of our Hopewell facility.

Other Expense, Net

Other expense, net for the year ended December 31, 2025 was $42.6 million, due to impairment losses recognized on our equity investments partially offset by government subsidy income and foreign exchange gains.

Other expense, net for the year ended December 31, 2024 was $12.6 million, due to foreign exchange losses, primarily from holding net monetary assets denominated in the RMB at certain U.S.

dollar functional entities, including BeiGene, Ltd.

dollar functional entities, including BeOne Medicines Ltd.

(the “Parent Company”), and unrealized losses on equity investments, partially offset by government subsidy income.

Other income, net for the year ended December 31, 2023 was $307.9 million, primarily due to the noncash gain of $362.9 million recorded for the receipt of our ordinary shares as consideration for our settlement with BMS and government subsidy income, partially offset by foreign exchange losses resulting from the strengthening of the U.S.

dollar compared to the RMB and the revaluation impact of RMB-denominated deposits held in U.S.

dollar functional currency subsidiaries and unrealized losses on equity investments.

Income Tax Expense

Income tax expense was $111.8 million for the year ended December 31, 2024 compared with $55.9 million for the year ended December 31, 2023.

The income tax expense for the year ended December 31, 2024 was primarily attributable to higher pre-tax income resulting in current U.S.

tax expense determined after other special tax deductions and research and development tax credits, including tax expense of $12.1 million due to the impact of tax reserves on uncertain tax positions related to research and development tax credits, lower taxable income in China, higher tax expense in certain EU and ROW jurisdictions and the deferred impact of the Company’s unremitted earnings in the U.S.

The Company’s tax expense for 2024 reflects the historic allocation of pre-tax earnings and losses among our significant jurisdictions.

This allocation and resulting tax expense depends on various factors including the level of income and unremitted earnings generated in the U.S., and amount of research and development costs incurred in China and therefore may vary from the historic allocation.

In December 2021, the Organization for Economic Cooperation and Development (“OECD”) enacted model rules for a new global minimum tax framework (“BEPS Pillar Two”), and various governments around the world have enacted, or are in the process of enacting legislation on this.

While we do not anticipate that this will have a material impact on our tax provision or effective tax rate, we will continue to monitor and assess pending legislation, guidance, and implementation by individual countries and evaluate the potential impact on our business in future periods.

This section of this Form 10-K generally discusses 2024 and 2023 items and year-to-year comparisons between 2024 and 2023.

Discussions of 2022 items and year-to-year comparisons between 2023 and 2022 can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

Our total income tax expense is substantially equal to our current tax expense and thus does not reflect any deferred tax benefits related to our net deferred tax assets due to the ASC 740, Income Taxes requirement to establish a valuation allowance against all such assets in all jurisdictions, thereby negating the tax benefit in the income statement, due to our three-year cumulative loss position.

Our discussion of income tax expense below is thus based on a comparison of our current tax expense in 2025 versus 2024.

Year Ended December 31,

2025 2024 2023

Current tax expense 120,452 85,778 55,185

Net deferred tax benefit (149,347) (131,279) (845,124)

Increase in valuation allowance 158,816 157,286 845,811

Total income tax expense 129,921 111,785 55,872

Income tax expense was $129.9 million ($120.5 million current tax) for the year ended December 31, 2025 compared with $111.8 million ($85.8 million current tax) for the year ended December 31, 2024.

The current income tax expense for the year ended December 31, 2025 was primarily attributable to higher currently taxable income primarily in China, Australia, and Italy, that resulted in an increase of $52.6 million offset with lower current tax in the U.S.

of $17.9 million.

The decrease in the U.S.

was driven by positive impacts of OBBBA, while the increase in other jurisdictions’ higher current taxable income was driven by (a) the increase in current year valuation allowances on short-term deferred tax assets that are triggered by our three-year cumulative loss position at a consolidated level, (b) increase in uncertain tax liabilities and (c) return to provision adjustments.

Given the Company’s recent history of earnings, management believes that there is a reasonable possibility that, within the next twelve months, sufficient positive evidence may become available to allow management to reach a conclusion that a significant portion of the valuation allowance recorded against the deferred tax assets held will be reversed.

The reversal would result in an income tax benefit for the quarterly and annual fiscal period in which the Company releases the valuation allowance.

However, the exact timing and amount of the valuation allowance release are subject to change on the basis of the level of profitability that the Company actually achieves.

Prior to reversal, income tax expense should trend with earnings per historical relationship.

On July 4, 2025, the reconciliation bill (H.R.

1), commonly referred to as the OBBBA, was signed into law and includes a broad range of tax reform provisions.

The OBBBA allows an elective deduction for domestic research and development expenses and, a reinstatement of elective 100% first-year bonus depreciation effective in tax year 2025, and a more favorable tax rate on foreign-derived deduction eligible income effective in tax year 2026.

The impact of certain elective provisions of the OBBBA has been included in the 2025 tax provision, resulting in a reduction of U.S.

income tax expense within our consolidated financial statements.

Non-GAAP Reconciliation

Year Ended December 31,

( in thousands)

( in thousands, except for per share data)

Reconciliation of GAAP to adjusted cost of sales - products:

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Adjusted operating expenses $ 3,599,097 $ 3,218,232

Reconciliation of GAAP to adjusted loss from operations:

GAAP loss from operations $ (568,199) $ (1,207,736)

Reconciliation of GAAP to adjusted income (loss) from operations:

GAAP income (loss) from operations $ 447,136 $ (568,199)

Share-based compensation expenses 510,247 441,793

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Amortization of intangibles 10,071 4,824

Adjusted income (loss) from operations $ 45,356 $ (752,473)

Adjusted income from operations $ 1,099,962 $ 45,356

Reconciliation of GAAP to adjusted net income (loss):

GAAP net income (loss) $ 286,933 $ (644,786)

Share-based compensation expenses 510,247 441,793

Depreciation 131,615 166,938

Amortization of intangibles 10,071 4,824

Impairment of equity investments 75,626 6,838

Discrete tax items 24,778 18,597

Income tax effect of non-GAAP adjustments (122,562) (49,123)

Adjusted net income (loss) $ 917,601 $ (54,919)

Year Ended December 31,

( in thousands, except for per share data)

Reconciliation of GAAP to adjusted EPS - basic

GAAP earnings (loss) per share - basic $ 0.20 $ (0.47)

Share-based compensation expenses 0.36 0.32

Depreciation 0.09 0.12

Amortization of intangibles 0.01 0.00

Other 0.00 0.00

Impairment of equity investments 0.05 0.00

Discrete tax items 0.02 0.01

Income tax effect of non-GAAP adjustments (0.09) (0.04)

Adjusted earnings (loss) per share - basic $ 0.65 $ (0.04)

Reconciliation of GAAP to adjusted EPS - diluted

GAAP earnings (loss) per share - diluted $ 0.19 $ (0.47)

Share-based compensation expenses 0.35 0.32

Depreciation 0.09 0.12

Amortization of intangibles 0.01 0.00

Other 0.00 0.00

Impairment of equity investments 0.05 0.00

Discrete tax items 0.02 0.01

Income tax effect of non-GAAP adjustments (0.08) (0.04)

Adjusted earnings (loss) per share - diluted $ 0.62 $ (0.04)

Reconciliation of GAAP to adjusted earnings (loss) per ADS - basic

GAAP earnings (loss) per ADS - basic $ 2.63 $ (6.12)

Share-based compensation expenses 4.68 4.20

Depreciation 1.21 1.59

Amortization of intangibles 0.09 0.05

Other 0.01 0.00

Impairment of equity investments 0.69 0.06

Discrete tax items 0.23 0.18

Income tax effect of non-GAAP adjustments (1.12) (0.47)

Adjusted earnings (loss) per ADS - basic $ 8.41 $ (0.52)

Reconciliation of GAAP to adjusted earnings (loss) per ADS - diluted

GAAP earnings (loss) per ADS - diluted 1

$ 2.53 $ (6.12)

Share-based compensation expenses 4.50 4.20

Depreciation 1.16 1.59

Amortization of intangibles 0.09 0.05

Other 0.01 0.00

Impairment of equity investments 0.67 0.06

Discrete tax items 0.22 0.18

Income tax effect of non-GAAP adjustments (1.08) (0.47)

Adjusted earnings (loss) per ADS - diluted $ 8.09 $ (0.52)

Year Ended December 31,

Free Cash Flow (Non-GAAP):

(in thousands)

Net cash provided by (used in) operating activities (GAAP) $ 1,127,580 $ (140,631)

Purchases of property, plant and equipment (185,839) (492,663)

Free Cash Flow (Non-GAAP) $ 941,741 $ (633,294)

Liquidity and Capital Resources

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Total debt $ 1,019,206 $ 1,018,013

We have incurred annual net losses and negative cash flows from operations since inception, resulting from the cost of funding our research and development programs and selling, general and administrative expenses associated with our operations, as well as supporting the commercialization of our products globally.

We incurred net losses of $0.6 billion and $0.9 billion for the years ended December 31, 2024 and 2023, respectively.

As of December 31, 2024, we had an accumulated deficit of $8.6 billion.

To date, we have financed our existing operations and investments in long-term assets principally through proceeds from public and private offerings of our securities, proceeds from debt and our collaborations, and since the third quarter of 2024 cash flow from operations.

Based on our current operating plan, we expect that our existing cash and cash equivalents as of December 31, 2024 will enable us to fund our operating expenses and planned long-term investments for at least the next 12 months after the date that the financial statements included in this report are issued.

We have also financed our operations and investments with proceeds from debt incurred primarily from various banks both through our subsidiaries and the Parent Company of $1.0 billion at December 31, 2024.

The majority of those debt obligations, or approximately $762.1 million, owed by BeiGene, Ltd., have due dates within the next 12 months.

As of December 31, 2024, BeiGene, Ltd.

will require loans or distributions from subsidiaries in fiscal year 2025 to fund its operations (see Note 10 in the Notes to the Financial Statements for further discussion of deferred taxes on the U.S.

unremitted earnings expected to be distributed to the Parent Company).

We believe we will have sufficient cash and cash equivalents and other sources of capital to be able to repay and/or refinance those debt obligations on a consolidated basis.

On December 15, 2021, we completed our initial public offering on the STAR Market of the Shanghai Stock Exchange (the “STAR Offering”).

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

As of December 31, 2024, the Company had cash remaining related to the STAR Offering proceeds of $0.6 billion.

The following table provides information regarding our cash flows for the years ended December 31, 2024 and 2023:

We have generated positive cash flow from operations since the third quarter of 2024.

We generated cash flows from operations of $1.1 billion for the year ended December 31, 2025, which is $1.3 billion higher than the year ended December 31, 2024.

Based on our recent and expected performance, we expect that our operating cash flows and existing cash and cash equivalents as of December 31, 2025 will enable us to fund our operating expenses and planned long-term investments for at least the next 12 months after the date that the financial statements included in this report are issued.

In 2025 we generated proceeds from long-term debt of $855.0 million which was used to pay off all existing short-term working capital loans, and include certain restrictive covenants as laid out further below with respect to certain coverage ratios and maximum investment amounts.

We believe we will have sufficient cash and cash equivalents and other sources of capital to be able to repay and/or refinance those debt obligations as they become due principally in 2027 and 2028.

Facilities Agreement

In November 2025, we entered into a Facilities Agreement (the “Facilities Agreement”) with a syndicate of banks.

The Facilities Agreement provides for a $140 million U.S.

dollar-denominated, 2-year, B1 revolving credit facility (the “B1 Revolving Loan Facility”), a $560 million 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 2.15 billion Renminbi-denominated, or approximately $300 million, 3-year, A term loan facility (the “A Loan Facility”) (collectively, the “Loan Facilities”).

Subsequently, we consummated the refinancing of our short-term (1 year tenor) working capital loans of approximately $768 million in aggregate through the proceeds from the B2 Term Loan Facility and A Loan Facility.

We paid $23 million in debt issuance costs for the Facilities Agreement from available cash and cash equivalents.

The refinancing extended the maturity of our working capital loans.

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 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, we are also required to pay a commitment fee of 0.85% on the undrawn and uncancelled amounts under the Loan Facilities.

The Facilities Agreement contains certain affirmative and negative covenants customary for financings of this type.

In addition, the Facilities Agreement contains financial covenants applicable to the Loan Facilities, including covenants requiring the maintenance of:

(i) a minimum cash interest coverage ratio of not less than 5.00 to 1.00;

(ii) a net leverage ratio of not greater than 2.50 to 1.00;

(iii) a minimum total consolidated shareholders’ equity of the Group of not less than $2.7 billion;

(iv) a minimum cash balance held outside the PRC by the Company and the Guarantors of $500.0 million;

(v) a maximum financial indebtedness of the Company and its subsidiaries not to exceed $2.0 billion;

and (vi) a maximum financial indebtedness of the Company’s subsidiaries that are incorporated or registered in the PRC not to exceed $500.0 million.

We were compliant with the required covenants as of December 31, 2025.

Sale of Future Royalties

The upfront payment from Royalty Pharma of $885 million in the third quarter of 2025 and the subsequent payment of $26 million in the fourth quarter of 2025 increased our cash and cash equivalents through financing cash inflows.

However, the repayment of this obligation to Royalty Pharma will be made upon the receipt of royalties from Amgen throughout the royalty period;

therefore, it has not been included in the total debt balance above, as there is no claim on unrestricted cash.

Our classification of the liability between current and non-current is based on our expectations of royalty revenue from Amgen over the next 12 months, which will be paid to Royalty Pharma in accordance with the terms of the Royalty Agreement.

Cash inflows from Amgen are classified as operating cash inflows, while the corresponding payments to Royalty Pharma are allocated between interest cash outflows within operating cash flows and a portion to reduce the liability, classified as a financing cash outflow.

Pursuant to the Royalty Agreement, in 2025, we paid to Royalty Pharma an aggregate of $9.6 million, of which $5.6 million was allocated as interest expense and recognized within operating cash flows, and $4.0 million was recorded as a reduction to the liability recorded within financing activities.

An additional $14.2 million of interest expense was accrued as of December 31, 2025.

Any cash received from Amgen but not yet remitted to Royalty Pharma as of the balance sheet date will be reflected as restricted cash in the Consolidated Balance Sheet.

There was no such restricted cash as of December 31, 2025.

The following table summarizes our cash and cash equivalent balances, cash flows and unused borrowing capacity available under our Facilities Agreement for the years indicated:

Year Ended December 31,

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Cash, cash equivalents and restricted cash at beginning of period $ 2,638,747 $ 3,185,984

Net cash used in operating activities (140,631) (1,157,453)

Net cash (used in) provided by investing activities (548,350) 60,004

Net cash provided by (used in) operating activities 1,127,580 (140,631)

Net cash used in investing activities (276,155) (548,350)

Net cash provided by financing activities 1,059,451 193,449

Net effect of foreign exchange rate changes 60,024 (51,705)

Net decrease in cash, cash equivalents and restricted cash (547,237) (689,053)

Net increase (decrease) in cash, cash equivalents and restricted cash 1,970,900 (547,237)

Cash, cash equivalents and restricted cash at end of period $ 4,609,647 $ 2,638,747

Unused borrowing capacity available under the Facilities Agreement, at end of year $ 140,000 $ —

Operating Activities

Cash used in operating activities improved versus the prior year due to our significantly improved revenue and $1.1 billion increase in gross margin in the current year and a decrease in cash used to fund working capital, offset by continued funding of our development pipeline, and commercial operations to support our global expansion.

Cash provided by operating activities increased by $1.3 billion versus the prior year due to our significantly improved revenue and $1.5 billion of increase in gross margin in the current year, offset by continued funding of our development pipeline and commercial operations, and positive cash flows from changes in working capital due to timing of accounts receivable collections and payments on accrued expenses.

Investing Activities

Investing activities used $548.4 million of cash for the year ended December 31, 2024, compared to $60.0 million of cash provided in the prior year due primarily to a decrease in proceeds from sales and maturities of investment securities, partially offset by a decrease in capital expenditures.

Investing activities used $276.2 million of cash for the year ended December 31, 2025, compared to $548.4 million of cash used in the prior year due primarily to a decrease in capital expenditures, partially offset by an increase in acquired in-process research and development and regulatory milestone payments.

Financing Activities

Financing activities provided $193.4 million of cash for the year ended December 31, 2024, compared to $416.5 million of cash provided in the prior year period due primarily to a net reduction in short-term debt borrowings.

Our borrowing and repayment cycle is dictated by the short-term maturities of our debt and the ability to increase our borrowings is dependent on interest rates, credit spreads, bank lending capacity and other factors.

We expect to repay approximately $851.5 million of loans in 2025 and expect to be able to re-finance those on a consistent basis with our historical experience, with the cost of those borrowings depending on prevailing interest rates and credit spreads.

Financing activities provided $1.1 billion of cash for the year ended December 31, 2025, compared to $193.4 million of cash provided in the prior year period due primarily to $911.0 million of proceeds from sale of future royalties and higher proceeds from option exercises and employee share purchase plan, partially offset by a net reduction in debt borrowings in the current year period and higher payroll tax payments upon vesting of share-based compensation awards.

In 2026, we expect to repay approximately $60.5 million of outstanding bank loans.

Effects of Exchange Rates on Cash

As noted above, we hold RMB denominated cash in our Parent Company (largely arising from the STAR Offering) and incur foreign currency gains or losses when remeasuring such cash to the U.S.

In the year ended December 31, 2024, we incurred realized losses on cash of $16.5 million that is included in the reconciling items between net loss and net cash used in operating activities on the consolidated statements of cash flows primarily related to the remeasurement of RMB denominated cash to USD.

As noted above, we hold RMB denominated cash in our Parent Company and incur foreign currency gains or losses when remeasuring such cash to the U.S.

In the year ended December 31, 2025, we incurred realized gains on cash of $4.2 million that is included in the reconciling items between net income and net cash provided by operating activities on the consolidated statements of cash flows primarily related to the remeasurement of RMB denominated cash to USD.

The RMB denominated cash in our Parent Company, however, is required to be used to fund RMB denominated expenditures and thus foreign currency gains or losses on such cash does not affect our ability to fund those expenditures.

We also have substantial operations in China, where the functional currency is the RMB and as such the net cash flows are translated to the U.S.

We have substantial operations in China and Europe, where the functional currency is the RMB and EUR and as such the net cash flows are translated to the U.S.

dollar for financial reporting.

This process generates translation gains and losses on RMB-denominated cash held in China that are included in the effects of foreign exchange rate changes on the consolidated statements of cash flows, as such translation gains and losses are excluded from cash flows from operating, investing and financing activities.

This process generates translation gains and losses on non-USD denominated cash held in those currency markets that are included in the effects of foreign exchange rate changes on the consolidated statements of cash flows, as such translation gains and losses are excluded from cash flows from operating, investing and financing activities.

Future Liquidity and Material Cash Requirements

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Co-development funding commitment 130,393 130,393 —

Funding commitment 7,404 1,838 5,566

Pension plan 16,405 3,922 12,483

Funding commitments 5,241 5,186 55

Capital commitments 46,431 46,431 —

1 unchanged sentence

Operating Lease Commitments

We lease office facilities in California, Massachusetts, Maryland, and New Jersey in the U.S.;

We lease office facilities in California and Massachusetts in the U.S.;

Basel, Switzerland;

4 unchanged sentences

Purchase Commitments

As of December 31, 2024, purchase commitments amounted to $131.9 million, of which $32.5 million related to minimum purchase requirements for supply purchased from CMOs and $99.4 million related to binding purchase order obligations of inventory from Amgen.

As of December 31, 2025, purchase commitments amounted to $205.2 million, of which $24.9 million related to non-utilization fees and minimum purchase requirements for supply purchased from CMOs and $180.3 million related to binding purchase order obligations of inventory from Amgen.

We do not have any minimum purchase requirements for inventory from Amgen.

4 unchanged sentences

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

However, our debt is primarily short-term in nature.

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

As of December 31, 2025, we are in compliance with all covenants of our material debt agreements.

2 unchanged sentences

For the purpose of contractual obligations calculation, current interest rates on floating rate obligations were used for the remainder contractual life of the outstanding borrowings.

Royalty Sale Liability

As described above, we have a contractual commitment to pay Royalty Pharma amounts received from Amgen related to Amgen’s sales of IMDELLTRA ® in certain markets outside of China.

While we have classified the upfront payment and the option exercise payment received from Royalty Pharma as a liability, the repayment of this obligation to Royalty Pharma will be made upon the receipt of royalties from Amgen throughout the royalty period, which is anticipated to extend at least through 2041.

We have not included this liability in the table above because it does not constitute a fixed contractual obligation or a cancellable commitment from which the upfront payment and option exercise payment could be demanded for refund.

Co-Development Funding Commitments

2 unchanged sentences

As of December 31, 2025, our remaining co-development funding commitment was $130.4 million.

Funding Commitment

Funding commitment represents our committed capital related to two of our equity method investments.

Funding Commitments

Funding commitments represent our committed capital related to equity investments.

As of December 31, 2025, our remaining capital commitment was $5.2 million and is expected to be paid from time to time over the investment period.

We maintain a defined benefit pension plan in Switzerland that is collectively financed by employer and employee contributions.

As of December 31, 2024, the plan was unfunded $16.4 million, with $3.9 million of employer contributions expected in 2025.

The timing and amount of future long-term funding requirements will vary as a result of future changes in staffing and compensation levels, various actuarial assumptions and actual investment returns on plan assets.

In the event of an underfunding, Switzerland pension foundations can levy additional contributions on the employer.

Capital Commitments

30 unchanged sentences

These significant assumptions are forward looking and could be affected by future economic, regulatory and market conditions.

At December 31, 2024, our existing deferred revenue balance was less than $1.0 million, and collaboration revenue is not expected to be a significant driver of our financial results until if and when additional agreements are entered into.

At December 31, 2025, our existing deferred revenue balance related to collaborative arrangements was less than $1.0 million, and collaboration revenue is not expected to be a significant driver of our financial results until if and when additional agreements are entered into.

Measurement of Accrued Research and Development Expenses

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Currently, we are in a three-year cumulative book loss position and as required by ASC 740, we provided a valuation allowance on all of our deferred tax assets.

If and when we are no longer in a three-year cumulative loss position, the subsequent measurement of our deferred tax assets will subject to the estimation process noted above.

Subsequent Measurement of Long-Lived Assets

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-K

Item 7. Management’s Discussion and Analysis