What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-06 compared with 2025-08-06 · 146 added, 127 removed, 341 unchanged (44% of the section changed)

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our ability to successfully commercialize our approved medicines and to obtain approvals in additional indications and territories for our medicines;

the timing, progress and results of our preclinical studies and clinical trials of our drug candidates, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;

our ability to successfully develop and commercialize our in-licensed medicines and drug candidates and any other medicines and drug candidates we may in-license;

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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 second quarter performance reinforces us as a global oncology leader and proves our ability to deliver sustainable, long-term growth.

BRUKINSA continues as the BTK inhibitor market leader in the US across five indications.

Our two additional Phase 3 hematology assets, BCL2 inhibitor sonrotoclax and BTK CDAC BGB-16673, have the potential to expand our franchise with pivotal data readouts and new trial initiations anticipated in the near-term.

At our recent Investor R&D Day, we outlined more than 20 expected R&D milestones in the next 18 months.

This includes advances across our solid tumor pipeline, where we are building future global franchises targeting a range of highly prevalent cancers.

Key highlights for the second quarter of 2025 are as follows:

• Second quarter 2025 total revenues increased 42% to $1.3 billion versus second quarter 2024

• Global BRUKINSA ® (zanubrutinib) revenues increased 49% to $950 million versus second quarter 2024

• Reported GAAP diluted Earnings per American Depositary Share (ADS) of $0.84, non-GAAP diluted Earnings per ADS of $2.25

• Anticipate 20+ near-term milestones in next 18 months across hematology and solid tumor pipeline

Our third quarter financial results show topline growth and a strong liquidity position to support ongoing operations and strategic priorities.

BRUKINSA is now the global revenue leader in the BTK inhibitor class.

Our late-stage hematology portfolio continues to advance with sonrotoclax and the BTK CDAC BGB-16673.

With a promising oncology pipeline, we are positioned to deliver multiple data and regulatory milestones.

Key highlights for the third quarter of 2025 are as follows:

• Third quarter 2025 total revenues increased 41% to $1.4 billion versus third quarter 2024

• Global BRUKINSA ® (zanubrutinib) revenues increased 51% to $1.0 billion versus third quarter 2024

• Diluted GAAP Earnings per American Depositary Share (“ADS”) of $1.09, non-GAAP diluted Earnings per ADS of $2.65

• Nearly 50 abstracts accepted at American Society of Hematology (ASH) Annual Meeting, highlighting late-stage hematology portfolio

Recent Developments

Recent Business Developments

On July 31, 2025, we announced that the European Medicines Agency (“EMA”) has granted PRIority MEdicines (PRIME) designation to the Company’s investigational Bruton’s tyrosine kinase (BTK) degrader, BGB-16673, for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor.

On July 28, 2025, we announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA ® (tislelizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.

On July 10, 2025, we announced that the European Commission has approved TEVIMBRA, in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma, not amenable to curative surgery or radiotherapy.

On June 26, 2025, we announced major advancements to our industry-leading oncology pipeline during our investor R&D Day.

On June 25, 2025, we announced that the CHMP of the European Medicines Agency issued a positive opinion recommending approval of a new film-coated tablet formulation of BRUKINSA ® (zanubrutinib) for all approved indications.

The CHMP positive opinion will now be reviewed by the European Commission, which will grant the marketing authorization for the tablet formulation in the European Union and in the European Economic Area countries Norway and Iceland.

On June 11, 2025, we announced that the U.S.

Food and Drug Administration approved a new tablet formulation of BRUKINSA for all five approved indications.

On May 27, 2025, we announced our new name and completed the redomiciliation to Switzerland, marking a significant milestone in the Company’s evolution.

On October 13, 2025, we announced that the U.S.

Food and Drug Administration (“FDA”) has granted Breakthrough Therapy Designation for sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

Additionally, the FDA has accepted BeOne’s request for participation in Project Orbis, an initiative that provides a framework for concurrent submission and review of oncology products among participating global health authorities.

On August 29, 2025, we announced positive topline results from a Phase 1/2 study (BGB-11417-201) of sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, in adult patients with relapsed/refractory mantle cell lymphoma, following treatment with a Bruton’s tyrosine kinase inhibitor (“BTKi”) and anti-CD20 therapy.

On August 27, 2025, we announced that the European Commission (“EC”) has approved TEVIMBRA (tislelizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment followed by TEVIMBRA monotherapy as adjuvant treatment, for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.

On August 25, 2025, we entered into a Royalty Purchase Agreement (the “Royalty Purchase 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 Inc.

(“Amgen”) based on annual net revenue from sales outside of China of any and all products that consist of Amgen’s IMDELLTRA ® (tarlatamab-dlle).

Under the terms of the Royalty Purchase Agreement, we received a non-refundable upfront payment of $885 million, and also have the option, in our sole discretion, to sell to Royalty Pharma an additional portion of our rights to royalty payments within 12 months of the date of the Royalty Purchase Agreement for up to $65 million, subject to proportional adjustments.

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.

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.

On August 21, 2025, we announced that the EC has approved a new film-coated tablet formulation of BRUKINSA ® (zanubrutinib) for all approved indications.

Results of Operations

The following table summarizes our results of operations for the three and six months ended June 30, 2025 and 2024:

Three Months Ended Six Months Ended

June 30, Change June 30, Change

The following table summarizes our results of operations for the three and nine months ended September 30, 2025 and 2024:

Three Months Ended Nine Months Ended

September 30, Change September 30, Change

2025 2024 $ % 2025 2024 $ %

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Product revenue, net $ 1,395,013 $ 993,447 $ 401,566 40.4 % $ 3,805,619 $ 2,661,511 $ 1,144,108 43.0 %

Collaboration revenue 13,224 8,020 5,204 64.9 % 21,973 12,754 9,219 72.3 %

Other revenue 17,271 8,152 9,119 111.9 % 39,244 20,906 18,338 87.7 %

Total revenues 1,412,284 1,001,599 410,685 41.0 % 3,844,863 2,682,417 1,162,446 43.3 %

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Interest income, net 3,029 10,643 (7,614) (71.5) % 12,374 40,028 (27,654) (69.1) %

Other income (expense), net 8,167 (11,984) 20,151 (168.1) % 12,117 (10,222) 22,339 (218.5) %

Other (expense) income, net (18,979) 11,318 (30,297) (267.7) % (6,862) 1,096 (7,958) (726.1) %

Income (loss) before income taxes 147,164 (98,304) 245,468 (249.7) % 267,613 (447,650) 715,263 (159.8) %

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Net income (loss) $ 124,841 $ (121,350) $ 246,191 (202.9) % $ 220,431 $ (492,905) $ 713,336 (144.7) %

Comparison of the Three Months Ended June 30, 2025 and 2024

Total revenue increased to $1,315.3 million for the three months ended June 30, 2025, from $929.2 million for the three months ended June 30, 2024, due to increased sales of BRUKINSA, TEVIMBRA, and our in-licensed products from Amgen.

Comparison of the Three Months Ended September 30, 2025 and 2024

Total revenue increased to $1,412.3 million for the three months ended September 30, 2025, from $1,001.6 million for the three months ended September 30, 2024, due to increased sales of BRUKINSA, TEVIMBRA, and our in-licensed products from Amgen.

Net product revenue consisted of the following:

Three Months Ended

June 30, Changes

September 30, Changes

2025 2024 $ %

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Total product revenue $ 1,395,013 $ 993,447 $ 401,566 40.4 %

Net product revenue increased 41.4% to $1,302.1 million for the three months ended June 30, 2025, compared to $921.1 million in the prior-year period, primarily due to increased sales of BRUKINSA globally, driven by continued growth in the U.S.

In addition, product revenues in the second quarter of 2025 were positively impacted by sales of TEVIMBRA and in-licensed products from Amgen, primarily XGEVA ® .

Global revenue for BRUKINSA totaled $949.8 million in the second quarter, representing a 49.0% increase compared to the prior-year period;

revenue for BRUKINSA totaled $683.7 million in the second quarter, compared to $479.4 million in the prior-year period, representing growth of 42.6%, driven primarily by robust demand growth across all indications and modest benefit due to net pricing.

Net product revenue increased 40.4% to $1,395.0 million for the three months ended September 30, 2025, compared to $993.4 million in the prior-year period, primarily due to increased sales of BRUKINSA in the U.S.

In addition, product revenues in the third quarter of 2025 were positively impacted by sales of TEVIMBRA and in-licensed products from Amgen, primarily XGEVA ® .

Global revenue for BRUKINSA totaled $1.0 billion in the third quarter, representing a 50.8% increase compared to the prior-year period;

revenue for BRUKINSA totaled $738.7 million in the third quarter, compared to $503.7 million in the prior-year period, representing growth of 46.6%, 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 revenue in Europe totaled $150.5 million in the second quarter, compared to $81.4 million in the prior-year period, representing growth of 84.9%, driven by increased market share across all major European markets, including Germany, Italy, Spain, France and the UK.

BRUKINSA revenue in Europe totaled $163.2 million in the third quarter, compared to $97.3 million in the prior-year period, representing growth of 67.8%, driven by increased market share across all major European markets, including Germany, Italy, Spain, France and the UK.

BRUKINSA revenue in China totaled $92.4 million, representing growth of 36.2%.

BRUKINSA rest of world revenue totaled $32.5 million in the second quarter, representing growth of 149.0% compared to the prior-year period.

Revenue for TEVIMBRA totaled $193.5 million in the second quarter, compared to $158.4 million in the prior-year period, representing a 22.2% increase.

Revenue for Amgen products in China totaled $126.3 million in the second quarter, compared to $90.1 million in the prior-year period, representing a 40.2% increase, driven primarily by increased XGEVA ® sales volume.

Collaboration revenue totaled $13.2 million and $8.0 million for the three months ended June 30, 2025 and 2024, respectively, primarily related to revenue generated under the Novartis broad markets marketing and promotion agreement and royalty revenue under the Amgen collaboration.

Gross margin on global product sales increased to $1,137.5 million for the three months ended June 30, 2025, compared to $783.0 million in the prior-year period, primarily due to increased product sales in the current year period.

Gross margin as a percentage of product sales increased to 87.4% for the three months ended June 30, 2025, from 85.0% in the comparable period of the prior year.

BRUKINSA rest of world revenue totaled $46.4 million in the third quarter, representing growth of 116.6% compared to the prior-year period.

Revenue for TEVIMBRA totaled $190.6 million in the third quarter, compared to $163.4 million in the prior-year period, representing a 16.7% increase.

Revenue for Amgen products in China totaled $133.1 million in the third quarter, compared to $101.6 million in the prior-year period, representing a 31.0% increase, driven primarily by increased XGEVA ® sales volume.

Other revenue totaled $17.3 million and $8.2 million for the three months ended September 30, 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 $1,198.5 million for the three months ended September 30, 2025, compared to $823.0 million in the prior-year period, primarily due to increased product sales in the current year period.

Gross margin as a percentage of product sales increased to 85.9% for the three months ended September 30, 2025, from 82.8% in the comparable period of the prior year.

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 cost of sales productivity improvements for both BRUKINSA and TEVIMBRA.

Gross margin also benefited from production productivity improvements for both BRUKINSA and TEVIMBRA.

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

On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 86.3%, from 84.9% in the comparable period of the prior year.

Research and Development Expense

Research and development expense increased by $70.4 million, or 15.5%, to $524.9 million for the three months ended June 30, 2025 from $454.5 million for the three months ended June 30, 2024.

The following table summarizes external clinical, external non-clinical and internal research and development expense for the three months ended June 30, 2025 and 2024, respectively:

Research and development expense increased by $27.5 million, or 5.5%, to $523.7 million for the three months ended September 30, 2025 from $496.2 million for the three months ended September 30, 2024.

The following table summarizes external clinical, external non-clinical and internal research and development expense for the three months ended September 30, 2025 and 2024, respectively:

Three Months Ended

June 30, Changes

September 30, Changes

2025 2024 $ %

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$ 445,904 $ 405,545 $ 40,359 10.0 %

Our co-funding obligation for the development of the pipeline assets under the Amgen collaboration for the three months ended June 30, 2025 totaled $52.2 million, of which $26.4 million was recorded as R&D expense.

Our co-funding obligation for the development of the pipeline assets under the Amgen collaboration for the three months ended September 30, 2025 totaled $59.4 million, of which $30.1 million was recorded as R&D expense.

The remaining $29.3 million was recorded as a reduction of the R&D cost share liability.

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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 in the second quarter 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), offset by lower development upfront and milestone fees.

Internal research and development expense increased by $19.7 million, or 6.7%, to $315.4 million, 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 and control spend.

The increase in external research and development expenses in the third quarter 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), offset by lower development upfront and milestone fees.

Internal research and development expense decreased by $5.3 million, or 1.6%, to $319.8 million for the three months ended September 30, 2025, from $325.1 million for the three months ended September 30, 2024.

Included within internal research and development expense for the three months ended September 30, 2024 is $24.9 million of accelerated depreciation expense related to the move of clinical production to larger, more efficient production lines.

Excluding the impact of the prior period accelerated depreciation, internal research and development expenses increased by $19.6 million 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 and control spend.

Selling, General and Administrative Expense

Three Months Ended

June 30, Changes

September 30, Changes

2025 2024 $ %

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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.

Selling, general and administrative expense increased by $94.2 million, or 21.2%, to $537.9 million for the three months ended June 30, 2025, from $443.7 million for the three months ended June 30, 2024.

Selling, general and administrative expense increased by $73.8 million, or 16.2%, to $529.0 million for the three months ended September 30, 2025, from $455.2 million for the three months ended September 30, 2024.

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 41.3% in the second quarter of 2025 compared to 48.2% in the prior-year period.

Selling, general and administrative expenses as a percentage of product sales were 37.9% in the third quarter of 2025 compared to 45.8% in the prior-year period.

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

Interest Income, Net

Interest income, net decreased by $9.7 million, or 73.6%, to $3.5 million for the three months ended June 30, 2025, from $13.2 million for three months ended June 30, 2024.

The decrease in interest income, net, was primarily attributable to decreased interest income resulting from lower interest rates on our cash and cash equivalents balance.

Interest expense increased resulting from higher interest rates on debt balance and lower interest capitalized related to completion of certain phases of our Hopewell facility.

Other Income (Expense), Net

Other income, net was $8.2 million for the three months ended June 30, 2025, primarily due to foreign exchange gains and government subsidy income, partially offset by unrealized losses on our equity investments.

For the three months ended June 30, 2024, other expense, net was $12.0 million, primarily due to foreign exchange losses.

Interest income, net decreased by $7.6 million, or 71.5%, to $3.0 million for the three months ended September 30, 2025, from $10.6 million for three months ended September 30, 2024.

The decrease in interest income, net, was primarily attributable an increase in interest expense 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 manufacturing and clinical R&D facility in Hopewell, New Jersey, slightly offset by an increase in interest income resulting from a higher cash and cash equivalents balance.

Other (Expense) Income, Net

Other expense, net was $19.0 million for the three months ended September 30, 2025, primarily due to impairment losses recognized on our equity investments and foreign exchange losses.

For the three months ended September 30, 2024, other income, net was $11.3 million, primarily due to foreign exchange gains.

Income Tax Expense

Income tax expense was $5.2 million for the three months ended June 30, 2025 as compared to $14.5 million for the three months ended June 30, 2024.

The income tax expense for the three months ended June 30, 2025 was primarily attributable to current Switzerland tax expense based on year to date earnings, current China tax expense due to certain non-deductible expenses, offset by discrete adjustments of approximately $14.2 million, primarily related to updated provision estimates for R&D tax credits.

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

Income tax expense was $22.3 million for the three months ended September 30, 2025 as compared to $23.0 million for the three months ended September 30, 2024.

The income tax expense for the three 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.

The income tax expense for the three 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.

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

We are in the process of evaluating the impact of the OBBBA on our consolidated financial statements.

While we have estimated the impact of certain elective provisions of the OBBBA, we do not expect the legislation to have a material impact on our consolidated financial statements.

Net Income (Loss) and Earnings Per Share

GAAP net income improved for the second quarter of 2025, as compared to the prior-year period loss, primarily attributable to revenue growth and improved operating leverage.

For the second quarter of 2025, basic and diluted earnings per share was $0.07 and $0.06 per share and $0.87 and $0.84 per American Depositary Share (“ADS”), respectively, compared to basic loss of $0.09 per share and $1.15 per ADS in the prior-year period.

Comparison of the Six Months Ended June 30, 2025 and 2024

Total revenue increased to $2,432.6 million, or 44.7%, for the six months ended June 30, 2025, from $1,680.8 million for the six months ended June 30, 2024, primarily due to increased sales of our internally developed products, BRUKINSA and tislelizumab, as well as increased sales of in-licensed products, most notably from the Amgen products.

GAAP net income improved for the third quarter of 2025, as compared to the prior-year period loss, primarily attributable to revenue growth and improved operating leverage.

For the third quarter of 2025, basic and diluted earnings per share was $0.09 and $0.08 per share and $1.13 and $1.09 per American Depositary Share (“ADS”), respectively, compared to basic loss of $0.09 per share and $1.15 per ADS in the prior-year period.

Comparison of the Nine Months Ended September 30, 2025 and 2024

Total revenue increased to $3,844.9 million, or 43.3%, for the nine months ended September 30, 2025, from $2,682.4 million for the nine months ended September 30, 2024, primarily due to increased sales of our internally developed products, BRUKINSA and TEVIMBRA, as well as increased sales of in-licensed products, most notably from the Amgen products.

Net product revenues consisted of the following:

Six Months Ended

June 30, Changes

Nine Months Ended

September 30, Changes

2025 2024 $ %

8 unchanged sentences

Total product revenue 3,805,619 2,661,511 1,144,108 43.0 %

Net product revenue increased 44.5% to $2,410.6 million for the six months ended June 30, 2025, compared to $1,668.1 million in the prior-year period, primarily due to increased sales of BRUKINSA globally, driven by continued growth in the U.S.

In addition, product revenues in the six months ended June 30, 2025 were positively impacted by sales of TEVIMBRA and in-licensed products from Amgen, primarily XGEVA ® .

Global sales of BRUKINSA totaled $1,741.5 million in the six months ended June 30, 2025, representing a 54.7% increase compared to the prior-year period.

sales of BRUKINSA totaled $1,246.9 million in the six months ended June 30, 2025, compared to $830.8 million in the prior-year period, representing growth of 50.1%, driven primarily by robust demand growth across all indications and modest benefit due to net pricing.

Net product revenue increased 43.0% to $3,805.6 million for the nine months ended September 30, 2025, compared to $2,661.5 million in the prior-year period, primarily due to increased sales of BRUKINSA globally, driven by continued growth in the U.S.

In addition, product revenues in the nine months ended September 30, 2025 were positively impacted by sales of TEVIMBRA and in-licensed products from Amgen, primarily XGEVA ® .

Global sales of BRUKINSA totaled $2,782.2 million in the nine months ended September 30, 2025, representing a 53.2% increase compared to the prior-year period.

sales of BRUKINSA totaled $1,985.6 million in the nine months ended September 30, 2025, compared to $1,334.6 million in the prior-year period, representing growth of 48.8%, 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 Europe totaled $266.4 million in the six months ended June 30, 2025, representing growth of 79.7% driven by increased market share across all major European markets, including Germany, Italy, Spain, France and the UK.

BRUKINSA sales in Europe totaled $429.6 million in the nine months ended September 30, 2025, representing growth of 75.0% driven by increased market share across all major European markets, including Germany, Italy, Spain, France and the UK.

BRUKINSA revenue in China totaled $256.7 million, representing growth of 35.9%.

BRUKINSA rest of world revenue totaled $63.9 million in the six months ended June 30, 2025, representing growth of 147.2% compared to the prior-year period.

Revenue for TEVIMBRA totaled $364.7 million in the six months ended June 30, 2025, compared to $303.7 million in the prior-year period, representing a 20.1% increase.

Revenue for Amgen products in China totaled $240.4 million in the six months ended June 30, 2025, compared to $162.0 million in the prior-year period, driven primarily by increased XGEVA ® sales volume.

Collaboration revenue totaled $22.0 million and $12.8 million for the six months ended June 30, 2025 and 2024, respectively, primarily related to revenue generated under the Novartis broad markets marketing and promotion agreement and royalty revenue under the Amgen collaboration.

Gross margin on product sales increased to $2,081.0 million for the six months ended June 30, 2025, compared to $1,405.0 million in the prior-year period, primarily due to increased product revenue in the current year period.

Gross margin as a percentage of product sales increased to 86.3% for the six months ended June 30, 2025, from 84.2% in the comparable period of the prior year.

BRUKINSA rest of world revenue totaled $110.3 million in the nine months ended September 30, 2025, representing growth of 133.3% compared to the prior-year period.

Revenue for TEVIMBRA totaled $555.3 million in the nine months ended September 30, 2025, compared to $467.0 million in the prior-year period, representing a 18.9% increase.

Revenue for Amgen products in China totaled $373.5 million in the nine months ended September 30, 2025, compared to $263.6 million in the prior-year period, driven primarily by increased XGEVA ® sales volume.

Other revenue totaled $39.2 million and $20.9 million for the nine months ended September 30, 2025 and 2024, respectively, primarily related to revenue generated under the Novartis broad markets marketing and promotion agreement and royalty revenue under the Amgen collaboration.

Gross margin on product sales increased to $3,279.5 million for the nine months ended September 30, 2025, compared to $2,228.0 million in the prior-year period, primarily due to increased product revenue in the current year period.

Gross margin as a percentage of product sales increased to 86.2% for the nine months ended September 30, 2025, from 83.7% in the comparable period of the prior year.

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 cost of sales productivity improvements for both BRUKINSA and TEVIMBRA.

Gross margin also benefited from production productivity improvements for both BRUKINSA and TEVIMBRA.

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

On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 86.7%, from 84.8% in the comparable period of the prior year.

Research and Development Expense

Research and development expense increased by $91.7 million, or 10.0%, to $1,006.8 million for the six months ended June 30, 2025 from $915.1 million for the six months ended June 30, 2024.

The following table summarizes external clinical, external non-clinical and internal research and development expense for the six months ended June 30, 2025 and 2024, respectively:

Six Months Ended

June 30, Changes

Research and development expense increased by $119.2 million, or 8.4%, to $1,530.4 million for the nine months ended September 30, 2025 from $1,411.3 million for the nine months ended September 30, 2024.

The following table summarizes external clinical, external non-clinical and internal research and development expense for the nine months ended September 30, 2025 and 2024, respectively:

Nine Months Ended

September 30, Changes

2025 2024 $ %

10 unchanged sentences

$ 1,311,156 $ 1,193,494 $ 117,662 9.9 %

Our co-funding obligation for the development of the pipeline assets under the Amgen collaboration for the six months ended June 30, 2025 totaled $92.7 million, of which $47.1 million was recorded as R&D expense.

Our co-funding obligation for the development of the pipeline assets under the Amgen collaboration for the nine months ended September 30, 2025 totaled $152.0 million, of which $77.2 million was recorded as R&D expense.

The remaining $74.8 million was recorded as a reduction of the R&D cost share liability.

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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 in the six months ended June 30, 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), offset by lower development upfront and milestone fees.

The increase in external research and development expenses in the nine months ended September 30, 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), offset by lower development upfront and milestone fees.

Internal research and development expense increased $16.2 million, or 1.8%, to $926.3 million 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 and control spend.

Included within internal research and development expenses for the nine months ended September 30, 2024 is $24.9 million of accelerated depreciation expense related to the move of clinical production to larger, more efficient production lines.

Selling, General and Administrative Expense

Six Months Ended

June 30, Changes

Nine Months Ended

September 30, Changes

2025 2024 $ %

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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.

Selling, general and administrative expense increased by $126.0 million, or 14.5%, to $997.2 million, for the six months ended June 30, 2025, from $871.2 million for the six months ended June 30, 2024.

Selling, general and administrative expense increased by $199.8 million, or 15.1%, to $1,526.2 million, for the nine months ended September 30, 2025, from $1,326.4 million for the nine months ended September 30, 2024.

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 41.4% for the six months ended June 30, 2025 compared to 52.2% in the prior-year period.

Selling, general and administrative expenses as a percentage of product sales were 40.1% for the nine months ended September 30, 2025 compared to 49.8% in the prior-year period.

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

Interest Income, Net

Interest income, net decreased by $20.0 million, or 68.2%, to $9.3 million for the six months ended June 30, 2025, from $29.4 million for the six months ended June 30, 2024.

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

Interest expense increased resulting from higher interest rates on debt balance and lower interest capitalized related to completion of certain phases of our Hopewell facility.

Other Income (Expense), Net

Other income, net was $12.1 million for the six months ended June 30, 2025, primarily due to foreign exchange gains and government subsidy income, partially offset by unrealized losses on our equity investments.

For the six months ended June 30, 2024, other expense, net was $10.2 million, primarily due to foreign exchanges 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.

functional currency subsidiaries.

Interest income, net decreased by $27.7 million, or 69.1%, to $12.4 million for the nine months ended September 30, 2025, from $40.0 million for the nine months ended September 30, 2024.

The decrease in interest income was primarily attributable to lower market interest rates earned on our cash and cash equivalents.

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) Income, Net

Other expense, net was $6.9 million for the nine months ended September 30, 2025, primarily due to to impairment losses recognized on our equity investments partially offset by government subsidy income and foreign exchange gains.

For the nine months ended September 30, 2024, other income, net was $1.1 million, primarily due to foreign exchanges gains.

Income Tax Expense

Income tax expense increased to $24.9 million for the six months ended June 30, 2025, from $22.2 million for the six months ended June 30, 2024.

The income tax expense for the six months ended June 30, 2025 was primarily attributable to current Switzerland tax expense based on year to date earnings, current China tax expense due to certain non-deductible expenses, offset by net discrete adjustments of approximately $8.7 million, primarily related to updated provision estimates for R&D tax credits.

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

Income tax expense increased to $47.2 million for the nine months ended September 30, 2025, from $45.3 million for the nine months ended September 30, 2024.

The income tax expense for the nine months ended September 30, 2025 was primarily attributable to current Switzerland tax expense based on year to date earnings, current China tax expense due to certain non-deductible expenses, offset by net discrete adjustments of approximately $9.7 million, primarily related to updated provision estimates for R&D tax credits.

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

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We are in the process of evaluating the impact of the OBBBA on our consolidated financial statements.

While we have estimated the impact of certain elective provisions of the OBBBA, we do not expect the legislation to have a material impact on our consolidated financial statements.

Net Income (Loss) and Earnings Per Share

GAAP net income improved for the six months ended June 30, 2025, as compared to the prior-year period loss, primarily attributable to revenue growth and improved operating leverage.

For the six months ended June 30, 2025, basic and diluted earnings per share was $0.07 per share and $0.89 and $0.85 per ADS, respectively, compared to basic loss of $0.27 per share and $3.56 per ADS in the prior-year period.

GAAP net income improved for the nine months ended September 30, 2025, as compared to the prior-year period loss, primarily attributable to revenue growth and improved operating leverage.

For the nine months ended September 30, 2025, basic and diluted earnings per share was $0.16 and $0.15 per share and $2.03 and $1.96 per ADS, respectively, compared to basic loss of $0.36 per share and $4.71 per ADS in the prior-year period.

Non-GAAP Reconciliation

Three Months Ended Six Months Ended

June 30, June 30,

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

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Adjusted earnings (loss) per ADS - diluted $ 2.65 $ 0.48 $ 6.14 $ (0.68)

For the second quarter of 2024, GAAP diluted loss per ADS includes $0.02 loss per ADS attributable to the dilutive ADS outstanding for purposes of this reconciliation.

For the third quarter of 2024, GAAP diluted loss per ADS includes $0.03 loss per ADS attributable to the dilutive ADS outstanding for purposes of this reconciliation.

As the Company was in a GAAP net loss position no diluted weighted average shares outstanding were calculated for US GAAP purposes.

Three Months Ended

June 30, Six Months Ended

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

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Liquidity and Capital Resources

The following table represents our cash and debt balances as of June 30, 2025 and December 31, 2024:

June 30, December 31,

The following table represents our cash and debt balances as of September 30, 2025 and December 31, 2024:

September 30, December 31,

(dollars in thousands)

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Total debt $ 952,867 $ 1,018,013

To date, we have financed our 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.

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

Based on our current operating plan, we expect that our operating cash flows and existing cash and cash equivalents 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 primarily incurred through various banks by both our subsidiaries and the Parent Company of $954.5 million as of June 30, 2025.

We paid down $71.1 million of the debt in the six months ended June 30, 2025 using existing cash.

We have also financed our operations and investments with proceeds from debt primarily incurred through various banks by both our subsidiaries and the Parent Company of $952.9 million as of September 30, 2025.

We paid down $75.3 million of the debt in the nine months ended September 30, 2025 using existing cash.

The majority of those debt obligations, or approximately $673.2 million, owed by BeOne Medicines Ltd.

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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.

The upfront payment from Royalty Pharma of $885 million in the third 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 partially paid to Royalty Pharma in accordance with the terms of the Royalty Purchase Agreement.

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

In the third quarter of 2025, there was no impact on operating cash flows resulting from the royalty revenue inflows from Amgen following the completion of the Royalty Purchase Agreement, nor were there any interest payments associated with the liability to Royalty Pharma.

Additionally, we did not repay any cash to Royalty Pharma during this period, which would have impacted our financing cash flows.

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 September 30, 2025.

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 June 30, 2025, we had cash remaining related to the STAR Offering proceeds of $359.5 million.

The following table provides information regarding our cash flows for the six months ended June 30, 2025 and 2024:

Six Months Ended

As of September 30, 2025, we had cash remaining related to the STAR Offering proceeds of $249.0 million.

The following table provides information regarding our cash flows for the nine months ended September 30, 2025 and 2024:

Nine Months Ended

September 30,

(dollars in thousands)

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Operating Activities

Cash provided by operating activities improved $711.8 million in the six months ended June 30, 2025, versus the prior year period due to our significantly improved revenue and $359.7 million of increase in gross margin in the current year period, offset by continued funding of our development pipeline and commercial operations, and increasing working capital to support our global expansion.

Cash provided by operating activities improved $926.0 million in the nine months ended September 30, 2025, versus the prior year period due to our significantly improved revenue and $1,069.9 million of increase in gross margin in the current year period, offset by continued funding of our development pipeline and commercial operations, and increasing working capital to support our global expansion.

Investing Activities

Investing activities used $188.5 million of cash in the six months ended June 30, 2025, compared to $320.9 million in the prior year period due primarily to a decrease in capital expenditures, partially offset by an increase in acquired in-process research and development and regulatory milestone payments.

Investing activities used $237.8 million of cash in the nine months ended September 30, 2025, compared to $454.7 million in the prior year period 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 $1.2 million of cash in the six months ended June 30, 2025, compared to $185.3 million in the prior year period due primarily to a net reduction in debt borrowings in the current year period and higher payroll tax payments upon vesting of share-based compensation awards, partially offset by higher proceeds from option exercises and employee share purchase plan.

Financing activities provided $962.5 million of cash in the nine months ended September 30, 2025, compared to $198.0 million in the prior year period due primarily to $885.0 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.

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

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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 six months ended June 30, 2025, we incurred realized gains on cash of $6.5 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.

In the nine months ended September 30, 2025, we incurred realized gains on cash of $4.0 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.

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Contractual and Other Obligations

The following table summarizes our significant contractual obligations as of the payment due date by period as of June 30, 2025:

The following table summarizes our significant contractual obligations as of the payment due date by period as of September 30, 2025:

Payments Due by Period

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Purchase Commitments

As of June 30, 2025, non-cancellable purchase commitments amounted to $130.1 million, of which $32.6 million related to minimum purchase requirements for supply purchased from contract manufacturers and $97.5 million related to binding purchase obligations of inventory from Amgen.

As of September 30, 2025, non-cancellable purchase commitments amounted to $175.1 million, of which $24.9 million related to non-utilization fees and minimum purchase requirements for supply purchased from contract manufacturers and $150.2 million related to binding purchase obligations of inventory from Amgen.

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

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

As of June 30, 2025, we were in compliance with all covenants of our material debt agreements.

As of September 30, 2025, we were in compliance with all covenants of our material debt agreements.

See above regarding Liquidity and Capital Resources and Note 11 in the Notes to the Condensed Consolidated Financial Statements for further detail of our debt obligations.

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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 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 could be demanded for refund.

Co-Development Funding Commitment

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We are funding our portion of the co-development costs by contributing cash and development services.

As of June 30, 2025, our remaining co-development funding commitment was $242.9 million.

As of September 30, 2025, our remaining co-development funding commitment was $183.6 million.

Funding Commitment

Funding commitment represents our committed capital related to equity investments.

As of June 30, 2025, our remaining capital commitment was $6.7 million and is expected to be paid from time to time over the investment period.

As of September 30, 2025, our remaining capital commitment was $6.0 million and is expected to be paid from time to time over the investment period.

Capital Commitments

We had capital commitments amounting to $62.0 million for the acquisition of property, plant and equipment as of June 30, 2025, related to various facilities across the globe, including the manufacturing and clinical R&D campus in Hopewell, New Jersey.

We had capital commitments amounting to $52.1 million for the acquisition of property, plant and equipment as of September 30, 2025, related to various facilities across the globe, including our Hopewell facility.

Critical Accounting Policies and Significant Judgments and Estimates

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We evaluate our estimates and judgments on an ongoing basis, and our actual results may differ from these estimates.

These include, but are not limited to, estimating the useful lives of long-lived assets, estimating variable consideration in product sales and collaboration revenue arrangements, estimating the incremental borrowing rate for operating lease liabilities, identifying separate accounting units 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 and the fair value of financial instruments.

We base our estimates on historical experience, known trends and events, contractual milestones and other various factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

Our actual results may differ from these estimates under different assumptions or conditions.

There have been no material changes to our critical accounting policies as of and for the three and six months ended June 30, 2025, as compared to those described in the section titled “Part II—Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024.

For new accounting policies adopted during the three and six months ended June 30, 2025, see “Part I—Item 1—Financial Statements—Notes to the Condensed Consolidated Financial Statements—1.

Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies—Significant accounting policies” in this Quarterly Report on Form 10-Q.

There have been no material changes to our critical accounting policies as of and for the three and nine months ended September 30, 2025, as compared to those described in the section titled “Part II—Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024.

For new accounting policies adopted during the three and nine months ended September 30, 2025, see “Part I—Item 1—Financial Statements—Notes to the Condensed Consolidated Financial Statements—1.

Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies—Significant accounting policies” in this Quarterly Report on Form 10-Q, other than the accounting for the sale of future royalty liability disclosed in Note 4.

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 2. Management’s Discussion and Analysis