What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-06 compared with 2025-11-06 · 203 added, 256 removed, 231 unchanged (67% 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;

the timing, progress and results of our research and development (“R&D”) programs, 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;

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 pricing and reimbursement of our medicines and drug candidates, if approved;

the initiation, timing, progress and results of our preclinical studies and clinical trials and our research and development programs;

our ability to advance our drug candidates into, and successfully complete, clinical trials and obtain regulatory approvals;

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our ability to attract and retain qualified employees and key personnel;

our ability to comply with the covenants and other requirements under our facilities agreements and to borrow available amounts under such agreements;

the impact of macroeconomic conditions, including uncertainties associated with geopolitical conflicts, tariff and trade policies, and inflation and capital market disruptions;

statements regarding future revenue, key milestones, expenses, capital expenditures, capital requirements and share performance;

and the future trading price of our ADSs, ordinary shares and RMB Shares, and impact of securities analysts’ reports on these prices.

the future trading price of our American Depositary Shares (“ADSs”) listed on Nasdaq, our ordinary shares listed on HKEx, and our ordinary shares issued to permitted investors in China and listed and traded on the STAR in Renminbi (“RMB Shares”), as well as the impact of securities analysts’ reports on these prices;

and the effects of the redomiciliation to Switzerland, including its tax treatment and our name change in 2025.

These statements involve risks and uncertainties, including those that are described in “Part II—Item 1A—Risk Factors” of this Quarterly Report, that may cause actual future events or results to differ materially from those expected.

Given these uncertainties, you should not place undue reliance on these forward-looking statements.

We do not assume any obligation to update any forward-looking statements where as a result of new information or otherwise, except as required by law.

We do not assume any obligation to update any forward-looking statements whether as a result of new information or otherwise, except as required by law.

This Quarterly Report includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties.

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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 expense.

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

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

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

BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide.

With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations.

Key highlights for the first quarter of 2026 are as follows:

• First quarter 2026 total global revenues increased 35% to $1.5 billion versus first quarter 2025

• Global BRUKINSA ® (zanubrutinib) revenues increased 38% to $1.1 billion versus first quarter 2025

• Diluted GAAP Earnings per American Depositary Share (“ADS”) of $1.96, non-GAAP diluted Earnings per ADS of $3.24

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

Recent Developments

Recent Business Developments

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.

Core Marketed Products

BRUKINSA (zanubrutinib)

• Received Orphan Drug Designation in Japan for the treatment of adult patients with relapsed or refractory (“R/R”) marginal zone lymphoma (“MZL”).

• Submitted New Drug Application in Japan for R/R MZL and tablet formulation.

Sonrotoclax (BCL2 inhibitor)

• Launched and commercially available in China for the treatment of adult patients with R/R mantle cell lymphoma (“MCL”) and R/R chronic lymphocytic leukemia (“CLL”)/small lymphocytic lymphoma (“SLL”).

• Included in the European Society of Medical Oncology (“ESMO”) guidelines as a recommended third-line treatment for R/R MCL patients.

TEVIMBRA (tislelizumab)

• Received acceptance of a Supplemental Biologics License Application (“sBLA”) by the U.S.

Food and Drug Administration (“FDA”) with Priority Review for the treatment of adult patients with first-line HER2-positive gastroesophageal adenocarcinoma (“GEA”) in combination with ZIIHERA (zanidatamab) and chemotherapy, based on results of the HERIZON-GEA-01 trial which demonstrated statistically significant and clinically meaningful improvement in overall survival versus trastuzumab plus chemotherapy.

• Received acceptance of sBLA by the Center for Drug Evaluation (“CDE”) in China for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA and chemotherapy.

ZIIHERA (zanidatamab)

• Received acceptance of sBLA by the CDE in China for the treatment of adult patients with first-line HER2-positive GEA in combination with chemotherapy, with or without TEVIMBRA.

Select Clinical-Stage Programs

• BGB-16673 (BTK chimeric degradation activation compound (“CDAC”)):

Initiated Phase 2 cohorts in R/R MZL and Richter’s Transformation.

Breast and Gynecological Cancers

• BGB-43395 (cyclin-dependent kinase 4 (“CDK4”) inhibitor):

Received acceptance of Phase 1 study data as a poster presentation at ASCO.

• BG-C9074 (B7-H4 ADC):

Received acceptance of Phase 1 study data as a rapid oral presentation at ASCO.

Gastrointestinal Cancers

• BGB-B2033 (GPC3x41BB bispecific antibody):

◦ Received FDA Orphan Drug Designation for hepatocellular carcinoma (“HCC”).

◦ Initiated potentially registrational study in patients with HCC.

◦ Received acceptance of Phase 1 study data as a rapid oral presentation at ASCO.

• BG-C0979 (ADAM9-targeting ADC):

Initiated first-in-human study.

Inflammation and Immunology

• BG-A3004 (KLRG1 mAb):

Initiated first-in-human study.

Results of Operations

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

The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:

Three Months Ended

March 31, Change

2026 2025 $ %

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Total operating expenses 1,096,321 941,175 155,146 16.5 %

Income (loss) from operations 163,114 (120,265) 283,379 (235.6) % 262,101 (488,774) 750,875 (153.6) %

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

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) %

Income from operations 249,902 11,102 238,800 2,151.0 %

Interest income 27,664 12,850 14,814 115.3 %

Interest expense (32,887) (7,002) (25,885) 369.7 %

Other income, net 14,536 3,950 10,586 268.0 %

Income before income taxes 259,215 20,900 238,315 1,140.3 %

Income tax expense 31,858 19,630 12,228 62.3 %

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 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 income $ 227,357 $ 1,270 $ 226,087 17,802.1 %

Comparison of the Three Months Ended March 31, 2026 and 2025

Total revenue increased to $1,513.4 million for the three months ended March 31, 2026, from $1,117.3 million for the three months ended March 31, 2025, 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:

Three Months Ended

September 30, Changes

March 31, Changes

2026 2025 $ %

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Total product revenue $ 1,487,329 $ 1,108,530 $ 378,799 34.2 %

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.

Net product revenue increased 34.2% to $1,487.3 million for the three months ended March 31, 2026, compared to $1,108.5 million in the prior-year period, primarily due to increased sales of BRUKINSA globally, driven by significant growth in the U.S.

In addition, product revenues in the first quarter of 2026 were positively impacted by growth from in-licensed products from Amgen and TEVIMBRA.

Global sales of BRUKINSA totaled $1,094.8 million in the first quarter, representing a 38.3% increase compared to the prior-year period;

sales of BRUKINSA totaled $761.1 million in the first quarter, compared to $563.2 million in the prior-year period, representing growth of 35.1%, driven primarily by robust demand growth as well as favorable net pricing, of which approximately $20.0 million relates to non-recurring gross to net adjustments realized in the first quarter of 2026.

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 $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 $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.

BRUKINSA sales in the EU totaled $182.4 million in the first quarter, compared to $115.9 million in the prior-year period, representing growth of 57.4%, driven by continued gains in market share across all major markets, including Germany, Italy, Spain, France and the UK.

Foreign exchange contributed approximately 11% of the European growth given the Euro strengthening on a year-over-year basis.

BRUKINSA sales in China totaled $94.0 million, representing growth of 15.9%.

BRUKINSA rest of world revenue totaled $57.3 million in the first quarter, representing growth of 82.3% compared to the prior-year period.

Sales of TEVIMBRA totaled $206.2 million in the first quarter, compared to $171.2 million in the prior-year period, representing a 20.5% increase.

Revenue for Amgen products in China totaled $142.2 million in the first quarter, compared to $114.1 million in the prior-year period, representing a 24.6% increase, driven primarily by increased XGEVA ® sales volume.

Other revenue totaled $26.1 million and $8.7 million for the three months ended March 31, 2026 and 2025, respectively, primarily related to royalty revenue under the Amgen collaboration and revenue generated under the Novartis broad markets marketing and promotion agreement.

Gross margin as a percentage of product sales increased to 88.8% for the three months ended March 31, 2026, from 85.1% 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 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.

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

On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 89.2%, from 85.5% in the comparable period of the prior year.

Research and Development Expense

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:

Research and development expense increased by $59.3 million, or 12.3%, to $541.2 million for the three months ended March 31, 2026 from $481.9 million for the three months ended March 31, 2025.

The following table summarizes the external cost of development programs, upfront license and development milestone fees, and internal research and development expense for the three months ended March 31, 2026 and 2025, respectively:

Three Months Ended

September 30, Changes

March 31, Changes

2026 2025 $ %

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Cost of development programs $ 157,557 $ 170,046 $ (12,489) (7.3) %

Upfront license and development milestone fees 191 5,000 (4,809) (96.2) %

Upfront license and development milestone fees 544 — 544 NM

Amgen co-development expense 1

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$ 465,904 $ 421,195 $ 44,709 10.6 %

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.

Our co-funding obligation for the development of the pipeline assets under the Amgen collaboration for the three months ended March 31, 2026 totaled $58.0 million, of which $29.4 million was recorded as R&D expense.

The remaining $28.6 million was recorded as a reduction for the R&D cost share liability.

Adjusted research and development expense is intended to provide investors and others with information about our performance without the effect of items that, by their nature, tend to obscure core operating results due to potential variability across periods based on the timing, frequency and magnitude of such items.

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 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.

External research and development expenses decreased slightly in the first quarter of 2026 compared to the same period in 2025.

This was primarily driven by the timing of comparator drug purchases, lower spend for maturing BRUKINSA studies, and the wind-down of the ociperlimab program.

These decreases were partially offset by increased investment in the continued advancement of several programs across the pipeline, including BTK CDAC, CDK4, and PRMT5, higher Amgen co-development expenses, and higher development upfront and milestone fees.

Internal research and development expense increased by $62.6 million, or 21.5%, to $353.7 million for the three months ended March 31, 2026, from $291.1 million for the three months ended March 31, 2025, as we continue to invest in capabilities to support a growing portfolio.

This increase was primarily attributable to the expansion of resources within the global development organization, alongside higher spending for toxicology studies, reagents, and consumables necessary to advance our clinical and preclinical candidates.

Selling, General and Administrative Expense

Three Months Ended

September 30, Changes

2025 2024 $ %

(dollars in thousands)

Selling, general and administrative expenses $ 528,998 $ 455,223 $ 73,775 16.2 %

Adjusted selling, general and administrative expenses 1

$ 434,484 $ 380,737 $ 53,747 14.1 %

Adjusted selling, general and administrative expense is intended to provide investors and others with information about our performance without the effect of items that, by their nature, tend to obscure core operating results due to potential variability across periods based on the timing, frequency and magnitude of such items.

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 $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 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 $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 $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.

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

1), commonly referred to as the One Big Beautiful Bill Act (“OBBBA”), was signed into law and includes a broad range of tax reform provisions that may affect our financial results.

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.

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 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:

Nine Months Ended

September 30, Changes

2025 2024 $ %

(dollars in thousands)

2,782,195 1,816,192 $ 966,003 53.2 %

555,311 467,038 88,273 18.9 %

235,984 161,880 74,104 45.8 %

79,969 53,712 26,257 48.9 %

57,513 48,019 9,494 19.8 %

35,486 40,398 (4,912) (12.2) %

Other 59,161 74,272 (15,111) (20.3) %

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

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 $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 $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 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 $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 $ %

(dollars in thousands)

External research and development expense:

Cost of development programs $ 526,239 $ 396,659 $ 129,580 32.7 %

Upfront license and development milestone fees 691 51,528 (50,837) (98.7) %

Amgen co-development expense 1

77,196 52,981 24,215 45.7 %

Total external research and development expenses 604,126 501,168 102,958 20.5 %

Internal research and development expenses 926,319 910,115 16,204 1.8 %

Total research and development expenses $ 1,530,445 $ 1,411,283 $ 119,162 8.4 %

Adjusted research and development expenses 2

$ 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 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.

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 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

Nine Months Ended

September 30, Changes

March 31, Changes

2026 2025 $ %

5 unchanged sentences

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 $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.

Selling, general and administrative expense increased by $95.8 million, or 20.9%, to $555.1 million for the three months ended March 31, 2026, from $459.3 million for the three months ended March 31, 2025.

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 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 $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.

Selling, general and administrative expenses as a percentage of product sales were 37.3% in the first quarter of 2026 compared to 41.4% in the prior-year period.

Interest Income

Interest income increased by $14.8 million, or 115.3%, to $27.7 million for the three months ended March 31, 2026, from $12.9 million for three months ended March 31, 2025.

The increase in interest income was primarily attributable to a higher cash and cash equivalents balance.

Interest Expense

Interest expense increased by $25.9 million, or 369.7%, to $32.9 million for the three months ended March 31, 2026, from $7.0 million for three months ended March 31, 2025.

The increase in interest expense was primarily attributable to 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 the completion of certain phases of our Hopewell facility.

Other Income, Net

Other income, net was $14.5 million for the three months ended March 31, 2026, primarily due to government subsidy income.

For the three months ended March 31, 2025, other income, net was $4.0 million, primarily due to foreign exchange gains and government subsidy income, partially offset by unrealized losses on our equity investments.

Income Tax Expense

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.

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

1), commonly referred to as the One Big Beautiful Bill Act (“OBBBA”), was signed into law and includes a broad range of tax reform provisions that may affect our financial results.

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 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.

Income tax expense was $31.9 million for the three months ended March 31, 2026 as compared to $19.6 million for the three months ended March 31, 2025.

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

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

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.

As of March 31, 2026, the Company had gross unrecognized tax benefits of $28.5 million.

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

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

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

The Company’s reserve for uncertain tax positions increased by $0.7 million in the three months ended March 31, 2026, primarily due to U.S.

federal and state tax credits and incentives.

Net Income and Earnings Per Share

GAAP net income improved for the first quarter of 2026, as compared to the prior-year period, primarily attributable to revenue growth and improved operating leverage.

For the first quarter of 2026, basic and diluted earnings per share was $0.16 and $0.15 per share and $2.05 and $1.96 per American Depositary Share (“ADS”), respectively, compared to $0.00 per share and $0.01 per ADS in the prior-year period.

Non-GAAP Reconciliation

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

( in thousands)

Three Months Ended

( Amounts in thousands of U.S.

dollars, except for per share and per ADS data)

Reconciliation of GAAP to adjusted cost of sales - products:

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Amortization of intangibles 1,742 1,173

Other — — 893 —

Adjusted cost of sales - products $ 161,147 $ 161,216

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Adjusted operating expenses $ 937,897 $ 816,706

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

GAAP income (loss) from operations $ 163,114 $ (120,265) $ 262,101 $ (488,774)

Reconciliation of GAAP to adjusted income from operations:

GAAP income from operations $ 249,902 $ 11,102

Share-based compensation expenses 123,348 95,451

1 unchanged sentence

Amortization of intangibles 1,759 1,190

Other — — 893 —

Adjusted income (loss) from operations $ 341,184 $ 65,630 $ 755,486 $ (33,247)

Reconciliation of GAAP to adjusted net income (loss):

GAAP net income (loss) $ 124,841 $ (121,350) $ 220,431 $ (492,905)

Adjusted income from operations $ 414,394 $ 139,357

Reconciliation of GAAP to adjusted net income:

GAAP net income $ 227,357 $ 1,270

Share-based compensation expenses 123,348 95,451

1 unchanged sentence

Amortization of intangibles 1,759 1,190

Other — — 893 —

Impairment of equity investments — 12,376

1 unchanged sentence

Income tax effect of non-GAAP adjustments (20,342) (11,237)

Adjusted net income (loss) $ 303,663 $ 51,582 $ 692,622 $ (71,020)

Adjusted net income $ 375,042 $ 136,137

Three Months Ended

( Amounts in thousands of U.S.

dollars, except for per share and per ADS data)

Reconciliation of GAAP to adjusted EPS - basic

GAAP earnings (loss) per share - basic $ 0.09 $ (0.09) $ 0.16 $ (0.36)

GAAP earnings per share - basic $ 0.16 $ 0.00

Share-based compensation expenses 0.09 0.07

1 unchanged sentence

Amortization of intangibles 0.00 0.00

Other 0.00 0.00 0.00 0.00

Impairment of equity investments 0.00 0.01

1 unchanged sentence

Income tax effect of non-GAAP adjustments 1

Adjusted earnings (loss) per share - basic $ 0.21 $ 0.04 $ 0.49 $ (0.05)

(0.01) (0.01)

Adjusted earnings per share - basic $ 0.26 $ 0.10

Reconciliation of GAAP to adjusted EPS - diluted

GAAP earnings (loss) per share - diluted $ 0.08 $ (0.09) $ 0.15 $ (0.36)

GAAP earnings per share - diluted $ 0.15 $ 0.00

Share-based compensation expenses 0.08 0.07

1 unchanged sentence

Amortization of intangibles 0.00 0.00

Other 0.00 0.00 0.00 0.00

Impairment of equity investments 0.00 0.01

1 unchanged sentence

Income tax effect of non-GAAP adjustments 1

Adjusted earnings (loss) per share - diluted $ 0.20 $ 0.04 $ 0.47 $ (0.05)

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

GAAP earnings (loss) per ADS - basic $ 1.13 $ (1.15) $ 2.03 $ (4.71)

(0.01) (0.01)

Adjusted earnings per share - diluted $ 0.25 $ 0.09

Reconciliation of GAAP to adjusted earnings per ADS - basic

GAAP earnings per ADS - basic $ 2.05 $ 0.01

Share-based compensation expenses 1.11 0.89

1 unchanged sentence

Amortization of intangibles 0.02 0.01

Other 0.00 0.00 0.01 0.00

Impairment of equity investments 0.00 0.12

1 unchanged sentence

Income tax effect of non-GAAP adjustments 1

Adjusted earnings (loss) per ADS - basic $ 2.76 $ 0.49 $ 6.38 $ (0.68)

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

GAAP earnings (loss) per ADS - diluted 1

(0.18) (0.11)

Adjusted earnings per ADS - basic $ 3.38 $ 1.27

Reconciliation of GAAP to adjusted earnings per ADS - diluted

GAAP earnings per ADS - diluted $ 1.96 $ 0.01

Share-based compensation expenses 1.07 0.86

1 unchanged sentence

Amortization of intangibles 0.02 0.01

Other 0.00 0.00 0.01 0.00

Impairment of equity investments 0.00 0.11

1 unchanged sentence

Income tax effect of non-GAAP adjustments 1

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

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 Nine Months Ended

September 30, September 30,

(0.18) (0.10)

Adjusted earnings per ADS - diluted $ 3.24 $ 1.22

1 Tax effect of non-GAAP adjustments is based on the statutory tax rate in the relevant tax jurisdiction.

Please note that the Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects.

Three Months Ended

Free Cash Flow (Non-GAAP):

Net cash provided by (used in) operating activities (GAAP) $ 402,553 $ 188,369 $ 710,233 $ (215,791)

Net cash provided by operating activities (GAAP) $ 201,336 $ 44,082

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

1 unchanged sentence

Liquidity and Capital Resources

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)

The following table represents our cash and debt balances as of March 31, 2026 and December 31, 2025:

March 31, December 31,

(in thousands)

Cash, cash equivalents and restricted cash $ 4,853,425 $ 4,609,647

Total debt $ 1,078,655 $ 1,019,206

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 $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.

mature within the next 12 months.

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.

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

Based on our current operating plan, we expect that our operating cash flows and existing cash and cash equivalents as of March 31, 2026 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 is associated with certain restrictive covenants as laid our 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 on a consolidated basis 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.

As of March 31, 2026, we had $312 million A Loan Facility and $560 million B2 Term Loan Facility outstanding under our Facilities Agreement.

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 March 31, 2026.

Sale of Future Royalties

The proceeds from sale of future royalties of $911 million in 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.

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 the three months ended March 31, 2026, we paid to Royalty Pharma an aggregate of $17 million, of which $14 million was allocated as interest expense and recognized within operating cash flows, and $3 million was recorded as reduction to the liability and recognized within financing activities.

An additional $18 million of interest expense was accrued as of March 31, 2026.

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 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,

There was no such restricted cash as of March 31, 2026.

The following table provides information regarding our cash and cash equivalents, cash flows and unused borrowing capacity available for the three months ended March 31, 2026 and 2025:

Three Months Ended

(dollars in thousands)

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

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

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

Net cash used in investing activities (45,510) (121,941)

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

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

Net effect of foreign exchange rate changes 19,320 3,480

1 unchanged sentence

Cash, cash equivalents and restricted cash at end of period $ 4,853,425 $ 2,530,591

Unused borrowing capacity available, at end of period $ 219,734 $ —

Operating Activities

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.

Cash provided by operating activities improved $157.3 million in the three months ended March 31, 2026, versus the prior year period due to our significantly improved gross margins in the current year period, offset by continued funding of our development pipeline and commercial operations, increasing working capital to support our global expansion and the timing of compensation-related payments.

Investing Activities

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.

Investing activities used $45.5 million of cash in the three months ended March 31, 2026, compared to $121.9 million in the prior year period due primarily to a decrease in capital expenditures and acquired in-process research and development and regulatory milestone payments.

Financing Activities

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.

We expect to repay approximately $813.3 million of loans in the next 12 months 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 $68.6 million of cash in the three months ended March 31, 2026, compared to $33.8 million used in the prior year period due primarily to a net increase in debt borrowings in the current year period, offset by lower proceeds from option exercises and the employee share purchase plan.

We expect to repay approximately $119.4 million of outstanding bank loans in the next 12 months.

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 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.

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

In the three months ended March 31, 2026, we incurred realized losses on cash of $3.4 million, which 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 monetary assets and liabilities denominated in currencies other than the USD to USD.

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

dollar for financial reporting.

This process generates translation gains and losses primarily on RMB-denominated cash held in China and Euro-denominated cash held in Europe 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 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

2 unchanged sentences

Contractual and Other Obligations

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

The following table summarizes our significant contractual obligations as of the payment due date by period as of March 31, 2026:

Payments Due by Period

11 unchanged sentences

Operating Lease Commitments

We lease office facilities in the U.S.

and Switzerland, and office and manufacturing facilities in China under non-cancelable operating leases expiring on various dates.

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

Basel, Switzerland;

and office or manufacturing facilities in Beijing, Shanghai, Suzhou and Guangzhou in China under non-cancelable operating leases expiring on various dates.

Payments under operating leases are expensed on a straight-line basis over the respective lease terms.

1 unchanged sentence

Purchase Commitments

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.

As of March 31, 2026, non-cancellable purchase commitments amounted to $186.4 million, of which $22.5 million related to non-utilization fees and minimum purchase requirements for supply purchased from contract manufacturers and $163.9 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 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 debt obligations if an event of default occurs.

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

As of March 31, 2026, we were in compliance with all covenants of our material debt agreements.

See above regarding Liquidity and Capital Resources and Note 10 in the Notes to the Condensed Consolidated Financial Statements for further detail of our debt obligations.

3 unchanged sentences

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.

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 the option exercise payment could be demanded for refund.

Co-Development Funding Commitment

Under the Amgen collaboration, we are responsible for co-funding global development costs for the licensed Amgen oncology pipeline assets up to a total cap of $1.25 billion.

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

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 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.

Under our collaboration with Amgen, we are responsible for co-funding global clinical development costs for the licensed oncology pipeline assets up to a total cap of $1.25 billion.

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

As of March 31, 2026, our remaining co-development funding commitment was $72.3 million.

Funding Commitments

Funding commitments represent our committed capital related to equity investments.

As of March 31, 2026, our remaining capital commitment was $4.4 million and is expected to be paid from time to time over the investment period.

Capital Commitments

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.

We had capital commitments amounting to $22.9 million for the acquisition of property, plant and equipment as of March 31, 2026, related to various facilities across the globe.

Critical Accounting Policies and Significant Judgments and Estimates

6 unchanged sentences

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 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.

There have been no material changes to our critical accounting policies as of and for the three months ended March 31, 2026, 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, 2025.

For new accounting policies adopted during the three months ended March 31, 2026, 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.

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