What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-06 compared with 2025-05-07 · 211 added, 87 removed, 257 unchanged (54% of the section changed)

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While we believe these industry publications and third-party research, surveys and studies are reliable, you are cautioned not to give undue weight to this information.

Unless the context requires otherwise, in this Quarterly Report, the terms “BeiGene,” the “Company,” “we,” “us” and “our” refer to BeiGene, Ltd., a Cayman Islands holding company with operations conducted by its subsidiaries, and its subsidiaries, on a consolidated basis.

Effective May 27, 2025, we changed our jurisdiction of incorporation from the Cayman Islands to Switzerland through a transaction known as a continuation under Section 206 of the Companies Act (as amended) of the Cayman Islands and Article 161 of the Swiss Federal Act on Private International Law (the “Continuation”) and changed our legal English name from BeiGene, Ltd.

to BeOne Medicines Ltd.

This Quarterly Report includes the results of BeiGene, Ltd.

prior to the Continuation and BeOne Medicines Ltd.

following the Continuation.

Unless the context requires otherwise, in this Quarterly Report, the terms “BeOne,” the “Company,” “we,” “us” and “our” refer to (i) BeOne Medicines Ltd., a Switzerland holding company with operations conducted by its subsidiaries, and its subsidiaries, on a consolidated basis, following the Continuation and (ii) BeiGene, Ltd., a Cayman Islands holding company with operations conducted by its subsidiaries, and its subsidiaries, on a consolidated basis, prior to the Continuation.

Non-GAAP Financial Measures

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

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

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

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

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

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

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

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

We achieved GAAP profitability in the first quarter of 2025 with continued global revenue growth.

In the U.S., BRUKINSA remains the leader in new CLL patient starts across all lines of therapy, and for the first time has become the overall BTKi market share leader.

We’ve made progress across our late-stage hematology and solid tumor pipelines, with multiple proof-of-concept readouts expected this year across our broad portfolio of antibody-drug conjugates, multispecific antibodies and targeted protein degraders.

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

• First quarter 2025 total revenues increased 49% to $1.1 billion with BRUKINSA® (zanubrutinib) global sales increasing 62%to $792 million on strong demand growth versus first quarter 2024

• Achieved GAAP profitability and significantly improved operating cash flow

• Advanced late-stage hematology and solid tumor pipelines with plan to host Investor R&D Day on June 26

• Secured shareholder approval to rename the Company to BeOne Medicines Ltd.

and redomicile to Switzerland

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

Recent Developments

Recent Business Developments

On April 29, 2025, we announced that the U.S.

Patent and Trademark Office rendered a Final Written Decision invalidating all claims of Pharmacyclics LLC’s U.S.

11,672,803 (the “‘803 patent”) that were challenged by BeiGene in a post-grant review (“PGR”) proceeding.

On April 3, 2025, we announced the discontinuation of our clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody, as a potential treatment for lung cancer.

On March 31, 2025, we announced the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA ® (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung cancer.

On March 4, 2025, we announced the U.S.

Food and Drug Administration has approved TEVIMBRA (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (≥1).

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.

Results of Operations

The following table summarizes our results of operations for the three months ended March 31, 2025 and 2024:

Three Months Ended

March 31, Change

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

2025 2024 $ % 2025 2024 $ %

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Interest income, net 3,497 13,225 (9,728) (73.6) % 9,345 29,385 (20,040) (68.2) %

Other income, net 3,950 1,762 2,188 124.2 %

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

Income (loss) before income taxes 99,549 (105,920) 205,469 (194.0) % 120,449 (349,346) 469,795 (134.5) %

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Net income (loss) $ 94,320 $ (120,405) $ 214,725 (178.3) % $ 95,590 $ (371,555) $ 467,145 (125.7) %

Comparison of the Three Months Ended March 31, 2025 and 2024

Total revenue increased to $1,117.3 million for the three months ended March 31, 2025, from $751.7 million for the three months ended March 31, 2024, due to increased sales of BRUKINSA, TEVIMBRA, and our in-licensed products from Amgen.

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.

Net product revenue consisted of the following:

Three Months Ended

March 31, Changes

June 30, Changes

2025 2024 $ %

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Total product revenue $ 1,302,076 $ 921,146 $ 380,930 41.4 %

Net product revenue increased 48.4% to $1,108.5 million for the three months ended March 31, 2025, compared to $746.9 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 first quarter of 2025 were positively impacted by sales of TEVIMBRA and in-licensed products from Amgen.

Global revenue for BRUKINSA totaled $791.7 million in the first quarter, representing a 62.1% increase compared to the prior-year period;

revenue for BRUKINSA totaled $563.2 million in the first quarter, compared to $351.5 million in the prior-year period, representing growth of 60.2%, driven primarily by demand, with the quarter over quarter growth coming primarily from expanded use in CLL as BRUKINSA continued to gain share as the leader in new patient starts in the U.S.

in CLL and all other approved indications.

BRUKINSA revenue in Europe totaled $115.9 million in the first quarter, compared to $66.8 million in the prior-year period, representing growth of 73.4%, driven by increased market share across all major European markets, including Germany, Italy, Spain, France and the UK.

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.

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 China totaled $83.2 million, representing growth of 30.8%.

BRUKINSA rest of world revenue totaled $31.4 million in the first quarter, representing growth of 145.4% compared to the prior-year period.

Revenue for TEVIMBRA totaled $171.2 million in the first quarter, compared to $145.3 million in the prior-year period, representing a 17.8% increase.

Revenue for Amgen products in China totaled $114.1 million in the first quarter, compared to $71.9 million in the prior-year period, representing a 58.7% increase, driven primarily by increased XGEVA ® sales volume.

Collaboration revenue totaled $8.7 million and $4.7 million for the three months ended March 31, 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 $943.5 million for the three months ended March 31, 2025, compared to $622.0 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 85.1% for the three months ended March 31, 2025, from 83.3% in the comparable period of the prior year.

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.

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

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Research and Development Expense

Research and development expense increased by $21.2 million, or 4.6%, to $481.9 million for the three months ended March 31, 2025 from $460.6 million for the three months ended March 31, 2024.

The following table summarizes external clinical, external non-clinical and internal research and development expense for the three months ended March 31, 2025 and 2024, respectively:

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:

Three Months Ended

March 31, Changes

June 30, Changes

2025 2024 $ %

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$ 444,057 $ 382,509 $ 61,548 16.1 %

Our co-funding obligation for the development of the pipeline assets under the Amgen collaboration for the three months ended March 31, 2025 totaled $40.5 million, of which $20.7 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 June 30, 2025 totaled $52.2 million, of which $26.4 million was recorded as R&D expense.

The remaining $25.8 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 first 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), and slightly offset by lower development upfront and milestone fees.

Internal research and development expense increased modestly by $1.9 million, or 0.6%, to $291.1 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 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.

Selling, General and Administrative Expense

Three Months Ended

March 31, Changes

June 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 $31.9 million, or 7.5%, to $459.3 million for the three months ended March 31, 2025, from $427.4 million for the three months ended March 31, 2024.

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

Selling, general and administrative expenses as a percentage of product sales were 41.4% in the first quarter of 2025 compared to 57.2% in the prior-year period.

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.

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.

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

Interest Income, Net

Interest income, net decreased by $10.3 million, or 63.8%, to $5.8 million for the three months ended March 31, 2025, from $16.2 million for three months ended March 31, 2024.

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 a higher debt balance and lower interest capitalized related to Hopewell construction in process.

Other Income, Net

Other income, net was $4.0 million for the three months ended March 31, 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 March 31, 2024, other income, net was $1.8 million, primarily due to government subsidy income, partially offset by foreign exchange losses resulting from the strengthening of the U.S.

dollar compared to the RMB in the period and the revaluation impact of foreign currencies held in U.S.

functional currency subsidiaries and unrealized losses on our equity investments.

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.

Income Tax Expense

Income tax expense was $19.6 million for the three months ended March 31, 2025 as compared to $7.7 million for the three months ended March 31, 2024.

The income tax expense for the three months ended March 31, 2025 and 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, current China tax expense due to certain non-deductible expenses, and other intercompany discrete adjustments.

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.

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.

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

Net Income (Loss) and Earnings Per Share

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

For the first quarter of 2025, both basic and diluted earnings per share was $0.00 per share and $0.01 per American Depositary Share (“ADS”), respectively, compared to basic loss of $0.19 per share and $2.41 per ADS in the prior-year period.

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.

Net product revenues consisted of the following:

Six Months Ended

June 30, Changes

2025 2024 $ %

(dollars in thousands)

1,741,504 1,125,914 $ 615,590 54.7 %

364,688 303,687 61,001 20.1 %

151,741 98,435 53,306 54.2 %

49,493 33,497 15,996 47.8 %

39,144 30,047 9,097 30.3 %

24,987 28,205 (3,218) (11.4) %

Other 39,049 48,279 (9,230) (19.1) %

Total product revenue 2,410,606 1,668,064 742,542 44.5 %

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.

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 revenue in China totaled $164.4 million, representing growth of 35.8%.

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.

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.

On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 86.9%, from 84.7% 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

2025 2024 $ %

(dollars in thousands)

External research and development expense:

Cost of development programs $ 352,613 $ 247,633 $ 104,980 42.4 %

Upfront license and development milestone fees 500 46,528 (46,028) (98.9) %

Amgen co-development expense 1

47,146 35,966 11,180 31.1 %

Total external research and development expenses 400,259 330,127 70,132 21.2 %

Internal research and development expenses 606,524 584,977 21,547 3.7 %

Total research and development expenses $ 1,006,783 $ 915,104 $ 91,679 10.0 %

Adjusted research and development expenses 2

$ 865,252 $ 787,949 $ 77,303 9.8 %

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.

The remaining $45.6 million was recorded as a reduction of 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 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.

Internal research and development expense increased $21.5 million, or 3.7%, to $606.5 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

Six Months Ended

June 30, Changes

2025 2024 $ %

(dollars in thousands)

Selling, general and administrative expenses $ 997,201 $ 871,156 $ 126,045 14.5 %

Adjusted selling, general and administrative expenses 1

$ 837,166 $ 736,068 $ 101,098 13.7 %

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 $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.

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.

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.

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.

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.

We are in the process of evaluating the impact of the OBBBA 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.

Non-GAAP Reconciliation

Three Months Ended

Three Months Ended Six Months Ended

June 30, June 30,

2025 2024 2025 2024

( in thousands)

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Amortization of intangibles 5,749 1,177 6,922 2,360

Other 893 — 893 —

Adjusted cost of sales - products $ 154,643 $ 134,271 $ 315,859 $ 255,678

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Amortization of intangibles 5,760 1,177 6,950 2,360

Other 893 — 893 —

Adjusted income (loss) from operations $ 274,945 $ 48,464 $ 414,302 $ (98,877)

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Amortization of intangibles 5,760 1,177 6,950 2,360

Other 893 — 893 —

Impairment of equity investments 3,118 — 15,494 —

Discrete tax items (14,210) 1,513 (8,737) 2,403

Income tax effect of non-GAAP adjustments (17,466) (13,439) (28,703) (23,082)

5 unchanged sentences

Amortization of intangibles 0.00 0.00 0.00 0.00

Other 0.00 0.00 0.00 0.00

Impairment of equity investments 0.00 0.00 0.01 0.00

Discrete tax items (0.01) 0.00 (0.01) 0.00

Income tax effect of non-GAAP adjustments (0.01) (0.01) (0.02) (0.02)

5 unchanged sentences

Amortization of intangibles 0.00 0.00 0.00 0.00

Other 0.00 0.00 0.00 0.00

Impairment of equity investments 0.00 0.00 0.01 0.00

Discrete tax items (0.01) 0.00 (0.01) 0.00

Income tax effect of non-GAAP adjustments (0.01) (0.01) (0.02) (0.02)

5 unchanged sentences

Amortization of intangibles 0.05 0.01 0.06 0.02

Other 0.01 0.00 0.01 0.00

Impairment of equity investments 0.03 0.00 0.14 0.00

Discrete tax items (0.13) 0.01 (0.08) 0.02

Income tax effect of non-GAAP adjustments (0.16) (0.13) (0.27) (0.22)

2 unchanged sentences

GAAP earnings (loss) per ADS - diluted 1

$ 0.84 $ (1.13) $ 0.85 $ (3.56)

Share-based compensation expenses 1.34 1.23 2.20 2.10

1 unchanged sentence

Amortization of intangibles 0.05 0.01 0.06 0.02

Other 0.01 0.00 0.01 0.00

Impairment of equity investments 0.03 0.00 0.14 0.00

Discrete tax items (0.13) 0.01 (0.08) 0.02

Income tax effect of non-GAAP adjustments (0.16) (0.13) (0.26) (0.22)

Adjusted earnings (loss) per ADS - diluted $ 2.25 $ 0.22 $ 3.48 $ (1.17)

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.

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

2025 2024 2025 2024

Free Cash Flow (Non-GAAP):

Net cash provided by (used in) operating activities (GAAP) $ 263,598 $ (95,588) $ 307,680 $ (404,160)

Purchases of property, plant and equipment (43,826) (109,950) (100,233) (266,528)

Free Cash Flow (Non-GAAP) $ 219,772 $ (205,538) $ 207,447 $ (670,688)

Liquidity and Capital Resources

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

March 31, December 31,

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

June 30, December 31,

(dollars in thousands)

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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 $923.6 million as of March 31, 2025.

We paid down $97.1 million of the debt in the first quarter of 2025 using existing cash.

The majority of those debt obligations, or approximately $670.5 million, owed by BeiGene, Ltd.

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.

The majority of those debt obligations, or approximately $672.3 million, owed by BeOne Medicines Ltd.

mature within the next 12 months.

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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 March 31, 2025, the Company had cash remaining related to the STAR Offering proceeds of $461.6 million.

The following table provides information regarding our cash flows for the three months ended March 31, 2025 and 2024:

Three Months Ended

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

(dollars in thousands)

2 unchanged sentences

Net cash used in investing activities (188,546) (320,863)

Net cash (used in) provided by financing activities (33,777) 162,293

Net cash provided by financing activities 1,248 185,310

Net effect of foreign exchange rate changes 26,957 (28,340)

Net decrease in cash, cash equivalents, and restricted cash (108,156) (378,548)

Net increase (decrease) in cash, cash equivalents, and restricted cash 147,339 (568,053)

Cash, cash equivalents and restricted cash at end of period $ 2,786,086 $ 2,617,931

Operating Activities

Cash provided by operating activities improved $352.7 million in the three months ended March 31, 2025, versus the prior year period due to our significantly improved revenue and $325.6 million of increase in gross margin 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.

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.

Investing Activities

Investing activities used $121.9 million of cash in the three months ended March 31, 2025, compared to $209.8 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.

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.

Financing Activities

Financing activities used $33.8 million of cash in the three months ended March 31, 2025, compared to $162.3 million of cash provided in the prior year period due primarily to a net reduction in short-term debt borrowings in the current year period, partially offset by higher proceeds from option exercises and employee share purchase plan.

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.

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 three months ended March 31, 2025, we incurred realized gains on cash of $3.2 million that is included in the reconciling items between net income and net cash provided by operating activities on the consolidated statements of cash flows primarily related to the remeasurement of RMB denominated cash to USD.

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.

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.

1 unchanged sentence

dollar for financial reporting.

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

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 March 31, 2025:

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

Payments Due by Period

16 unchanged sentences

Purchase Commitments

As of March 31, 2025, non-cancellable purchase commitments amounted to $152.9 million, of which $31.0 million related to minimum purchase requirements for supply purchased from contract manufacturers and $121.9 million related to binding purchase obligations of inventory from Amgen.

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.

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

6 unchanged sentences

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 March 31, 2025, 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 Financial Statements for further detail of our debt obligations.

As of June 30, 2025, 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.

Interest on bank loans is paid quarterly until the respective loans are fully settled.

3 unchanged sentences

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

As of March 31, 2025, our remaining co-development funding commitment was $295.1 million.

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

Funding Commitment

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

As of March 31, 2025, our remaining capital commitment was $5.9 million and is expected to be paid from time to time over the investment period.

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.

Capital Commitments

We had capital commitments amounting to $56.3 million for the acquisition of property, plant and equipment as of March 31, 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 $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.

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 months ended March 31, 2025, as compared to those described in the section titled “Part I—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 months ended March 31, 2025, see “Part I—Item 1—Financial Statements—Notes to the Condensed Consolidated Financial Statements—1.

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.

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