BeOne Medicines Announces Fourth Quarter and Full Year 2025 Financial Results, Highlighting Global Success of BRUKINSA and Foundational Oncology Leadership

SAN CARLOS, Calif.--( BUSINESS WIRE)-- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the fourth quarter and full year 2025.

“These strong financial results for the fourth quarter and full year 2025 underscore our continued evolution as a global oncology leader with durable competitive advantages in clinical development and manufacturing and one of the industry’s deepest and most differentiated pipelines,” said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. “BRUKINSA has firmly established itself as the global leader in the BTK inhibitor class, distinguished by broad regulatory approvals, expanding geographic reach, strong physician adoption, and unmatched long-term efficacy and safety data in CLL. At the same time, we are securing new indications and expanded reimbursement for TEVIMBRA across key markets worldwide. With our late-stage, foundational hematology assets nearing commercialization and a robust solid tumor portfolio delivering encouraging data, we are well positioned to extend our leadership and drive the next phase of sustainable global growth.”

(Amounts in thousands of U.S. dollars full year GAAP amounts audited, all other amounts unaudited)

Fourth Quarter

Full Year

2025

2024

% Change

2025

2024

% Change

Net product revenues

1,476,442

1,118,035

5,282,061

3,779,546

Other revenue

21,728

9,789

122

60,972

30,695

Total revenue

1,498,170

1,127,824

5,343,033

3,810,241

GAAP income (loss) from operations

185,035

(79,425

)

333

447,136

(568,199

)

179

Adjusted income from operations*

344,476

78,603

338

1,099,962

45,356

2325

GAAP net income (loss)

66,502

(151,881

)

144

286,933

(644,786

)

145

Adjusted net income (loss)*

224,979

16,101

1297

917,601

(54,919

)

1771

GAAP basic earnings (loss) per ADS

0.60

(1.43

)

142

2.63

(6.12

)

143

Adjusted basic earnings (loss) per ADS*

2.03

0.15

1253

8.41

(0.52

)

1717

GAAP diluted earnings (loss) per ADS

0.58

(1.43

)

141

2.53

(6.12

)

141

Adjusted diluted earnings (loss) per ADS*

1.95

0.15

1200

8.09

(0.52

)

1656

Free Cash Flow*

379,825

(17,320

)

2293

941,741

(633,294

)

249

* For an explanation of our use of non-GAAP financial measures refer to the “Note Regarding Use of Non-GAAP Financial Measures” section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measures, see the table at the end of this press release.

Fourth Quarter and Full Year 2025 Financial Results

Product Revenue, which represents 99% of total revenue, totaled $1.5 billion and $5.3 billion for the fourth quarter and full year of 2025, representing growth of 32% and 40%, compared to the prior-year periods.

Gross Margin as a percentage of global product sales for the fourth quarter and full year of 2025 was 90.4% and 87.3%, compared to 85.6% and 84.3%, in the prior-year periods on a GAAP basis. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of global product sales increased to 90.7% and 87.8% for the fourth quarter and full year of 2025, compared to 87.4% and 85.5%, in the prior-year periods.

Operating Expenses

The following table summarizes operating expenses for the fourth quarter of 2025 and 2024:

GAAP

Non-GAAP

(in thousands, except percentages)

Q4 2025

Q4 2024

% Change

Q4 2025

Q4 2024

% Change

Research and development

615,423

542,012

544,823

474,874

Selling, general and administrative

555,290

504,677

471,468

433,059

Total operating expenses

1,170,713

1,046,689

1,016,291

907,933

The following table summarizes operating expenses for the full year 2025 and 2024:

GAAP

Non-GAAP

(in thousands, except percentages)

FY 2025

FY 2024

% Change

FY 2025

FY 2024

% Change

Research and development

2,145,868

1,953,295

1,855,979

1,668,368

Selling, general and administrative

2,081,489

1,831,056

1,743,118

1,549,864

Total operating expenses

4,227,357

3,784,351

3,599,097

3,218,232

Research and Development (R&D) Expenses increased for the fourth quarter and full year of 2025 compared to the prior-year periods on both a GAAP and adjusted basis. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled nil and $0.7 million in the fourth quarter and full year of 2025, compared to $63 million and $114 million in the prior-year periods.

Selling, General and Administrative (SG&A) Expenses increased for the fourth quarter and full year of 2025 compared to the prior-year periods on both a GAAP and adjusted basis. SG&A expenses as a percentage of product sales were 38% and 39% for the fourth quarter and full year of 2025, compared to 45% and 48% in the prior-year periods.

Net Income/(Loss) and Basic/Diluted Earnings Per Share

GAAP net income for the fourth quarter and full year of 2025 was $67 million and $287 million, an increase of $218 million and $932 million, over the prior-year periods, primarily attributable to revenue growth and improved operating leverage. Included within GAAP net income for full year 2025 were $76 million of equity investment impairment charges, $25 million of non-recurring tax expenses and $20 million of timing related tax expenses in certain jurisdictions, which were primarily incurred in the fourth quarter.

For the fourth quarter of 2025, basic and diluted earnings per share were $0.05 and $0.04 per share and $0.60 and $0.58 per American Depositary Share (ADS), compared to basic loss of $0.11 per share and $1.43 per ADS in the prior-year period. For the full year of 2025, basic and diluted earnings per share were $0.20 and $0.19 per share and $2.63 and $2.53 per ADS, compared to basic loss of $0.47 per share and $6.12 per ADS in the prior-year period.

Free Cash Flow for the fourth quarter of 2025 was $380 million, representing an increase of $397 million over the prior-year period. For the full year of 2025, free cash flow was $942 million, representing an increase of $1.6 billion over the prior-year period.

For further details on BeOne’s 2025 Financial Statements, please see BeOne’s Annual Report on Form 10-K for fiscal year 2025 filed with the U.S. Securities and Exchange Commission.

Full Year 2026 Guidance

BeOne’s financial guidance is summarized below:

FY 2026 1

Total revenue

$6.2 - $6.4 billion

GAAP gross margin %

High-80% range

GAAP operating expenses 2

(combined R&D and SG&A)

$4.7 - $4.9 billion

GAAP operating income 2

$700 - $800 million

Non-GAAP operating income 2,3

$1.4 - $1.5 billion

1 Assumes January 1, 2026 foreign exchange rates.

2 Does not assume any potential new, material business development activity or unusual/non-recurring items.

3 Non-GAAP operating income is a financial measure that excludes from the corresponding GAAP measure costs related to share-based compensation, depreciation and amortization expense. Guidance assumes that Non-GAAP expenses track overall expense growth.

BeOne’s total revenue guidance for full year 2026 of $6.2 billion to $6.4 billion includes expectations for strong revenue growth driven by BRUKINSA’s U.S. leadership position and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the high-80% range and includes the impact of product mix and a full year of 2026 productivity improvements. Guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth in both commercial and research at a pace that continues to deliver meaningful operating leverage.

The Company is providing the following additional guidance on items impacting net income and earnings per ADS:

Fourth Quarter Business Highlights

Core Marketed Products

BRUKINSA (zanubrutinib)

Sonrotoclax (BCL2 inhibitor)

TEVIMBRA (tislelizumab)

Select Clinical-Stage Programs

Hematology

Breast and Gynecologic Cancers

Lung Cancer

Gastrointestinal Cancers

Anticipated R&D Milestones

Programs

Timing

BRUKINSA

1H 2026

TEVIMBRA

1H 2026

2H 2026

Hematology

FDA regulatory action on New Drug Application as monotherapy treatment of adult patients with R/R MCL.

1H 2026

Phase 3 trial initiation for the treatment of adult patients with R/R multiple myeloma t(11;14).

2H 2026

Phase 2 potential accelerated approval submission (if data support) for the treatment of adult patients with R/R CLL.

2H 2026

Breast/Gynecologic Cancers

1H 2026

Phase 3 trial initiation for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer.

Gastrointestinal Cancers

2H 2026

Potentially registrational Phase 2 trial initiation.

Inflammation and Immunology

Phase 1/2 trial data readout for the treatment of adult patients with rheumatoid arthritis.

2H 2026

Phase 1b trial data readout for the treatment of adult patients with moderate to severe chronic spontaneous urticaria.

1H 2026

BeOne’s Earnings Results Webcast

The Company’s earnings conference call for the fourth quarter and full year 2025 will be broadcast via webcast at 8:00 a.m. ET on Thursday, February 26, 2026, and will be accessible through the Investors section of BeOne’s website at www.beonemedicines.com. Supplemental information in the form of a slide presentation, transcript of prepared remarks, and a replay of the webcast will also be available.

About BeOne

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. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding: potential commercialization of BeOne’s late-stage hematology assets; BeOne’s next phase of global growth; BeOne’s future revenue, gross margin percentage, operating expenses, operating income, other income or expense, income tax and diluted ADS outstanding; BeOne’s expectations regarding continued global expansion and investment to support growth; upcoming R&D milestones to be achieved by BeOne; the timing of clinical developments and data readouts; and BeOne’s plans, commitments, aspirations and goals under the caption “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent periodic report filed with the U.S. Securities and Exchange Commission (“SEC”), as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the SEC. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. BeOne’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties.

Condensed Consolidated Statements of Operations (U.S. GAAP)

(Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data)

Fourth Quarter

Full Year

2025

2024

2025

2024

(unaudited)

(audited)

Revenue

Product revenue, net

1,476,442

1,118,035

5,282,061

3,779,546

Other revenue

21,728

9,789

60,972

30,695

Total revenues

1,498,170

1,127,824

5,343,033

3,810,241

Cost of sales – products

142,422

160,560

668,540

594,089

Gross profit

1,355,748

967,264

4,674,493

3,216,152

Operating expenses

Research and development

615,423

542,012

2,145,868

1,953,295

Selling, general and administrative

555,290

504,677

2,081,489

1,831,056

Total operating expenses

1,170,713

1,046,689

4,227,357

3,784,351

Income (loss) from operations

185,035

(79,425

)

447,136

(568,199

)

Interest income

26,770

14,707

70,505

69,641

Interest expense

(26,873

)

(6,899

)

(58,234

)

(21,805

)

Other expense, net

(35,691

)

(13,734

)

(42,553

)

(12,638

)

Income (loss) before income taxes

149,241

(85,351

)

416,854

(533,001

)

Income tax expense

82,739

66,530

129,921

111,785

Net income (loss)

66,502

(151,881

)

286,933

(644,786

)

Earnings (loss) per share

Basic

0.05

(0.11

)

0.20

(0.47

)

Diluted

0.04

(0.11

)

0.19

(0.47

)

Weighted-average shares outstanding—basic

1,439,485,461

1,381,378,234

1,417,803,727

1,368,746,793

Weighted-average shares outstanding—diluted

1,499,900,248

1,381,378,234

1,474,829,908

1,368,746,793

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

Basic

0.60

(1.43

)

2.63

(6.12

)

Diluted

0.58

(1.43

)

2.53

(6.12

)

Weighted-average ADSs outstanding—basic

110,729,651

106,259,864

109,061,825

105,288,215

Weighted-average ADSs outstanding—diluted

115,376,942

106,259,864

113,448,454

105,288,215

Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)

(Amounts in thousands of U.S. Dollars)

As of December 31,

2025

2024

(audited)

Assets:

Cash, cash equivalents and restricted cash

4,609,647

2,638,747

Accounts receivable, net

865,080

676,278

Inventories, net

608,227

494,986

Property, plant and equipment, net

1,641,678

1,578,423

Total assets

8,188,573

5,920,910

Liabilities and equity:

Accounts payable

479,035

404,997

Accrued expenses and other payables

1,109,120

803,713

Royalty financing liability

906,956

—

R&D cost share liability

64,345

165,440

Debt

1,019,206

1,018,013

Total liabilities

3,827,379

2,588,688

Total equity

4,361,194

3,332,222

Select Condensed Consolidated Statements of Cash Flows (U.S. GAAP)

(Amounts in thousands of U.S. Dollars)

Fourth Quarter

Full Year

2025

2024

2025

2024

(unaudited)

(audited)

Cash, cash equivalents and restricted cash at beginning of period

4,110,542

2,713,428

2,638,747

3,185,984

Net cash provided by (used in) operating activities

417,347

75,160

1,127,580

(140,631

)

Net cash used in investing activities

(38,335

)

(93,605

)

(276,155

)

(548,350

)

Net cash provided by (used in) financing activities

96,931

(4,523

)

1,059,451

193,449

Net effect of foreign exchange rate changes

23,162

(51,713

)

60,024

(51,705

)

Net increase (decrease) in cash, cash equivalents and restricted cash

499,105

(74,681

)

1,970,900

(547,237

)

Cash, cash equivalents and restricted cash at end of period

4,609,647

2,638,747

4,609,647

2,638,747

Note Regarding Use of Non-GAAP Financial Measures

BeOne provides certain non-GAAP financial measures, including Adjusted Operating Expenses, Adjusted Operating Loss, Adjusted Net Income, Adjusted Earnings Per Share, Free Cash Flow and certain other non-GAAP income statement line items, each of which include adjustments to GAAP figures. These non-GAAP financial measures are intended to provide additional information on BeOne’s operating performance. Adjustments to BeOne’s GAAP figures exclude, as applicable, non-cash items such as share-based compensation, depreciation and amortization. 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 U.S. 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. BeOne maintains an established non-GAAP policy that guides the determination of what costs will be excluded in non-GAAP financial measures and the related protocols, controls and approval with respect to the use of such measures. BeOne believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of BeOne’s operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of BeOne’s 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 BeOne’s management uses for planning and forecasting purposes and measuring BeOne’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. 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.

RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES

(Amounts in thousands of U.S. Dollars)

(unaudited)

Fourth Quarter

Full Year

2025

2024

2025

2024

Reconciliation of GAAP to adjusted cost of sales - products:

GAAP cost of sales – products

142,422

160,560

668,540

594,089

Less: Depreciation

3,474

18,089

13,669

42,707

Less: Amortization of intangibles

1,545

1,183

10,004

4,729

Less: Other

—

893

—

Adjusted cost of sales – products

137,403

141,288

643,974

546,653

Reconciliation of GAAP to adjusted research and development:

GAAP research and development

615,423

542,012

2,145,868

1,953,295

Less: Share-based compensation expenses

52,442

44,992

217,440

186,113

Less: Depreciation

18,158

22,146

72,449

98,814

Adjusted research and development

544,823

474,874

1,855,979

1,668,368

Reconciliation of GAAP to adjusted selling, general and administrative:

GAAP selling, general and administrative

555,290

504,677

2,081,489

1,831,056

Less: Share-based compensation expenses

71,015

62,790

292,807

255,680

Less: Depreciation

12,785

8,811

45,497

25,417

Less: Amortization of intangibles

Adjusted selling, general and administrative

471,468

433,059

1,743,118

1,549,864

Reconciliation of GAAP to adjusted operating expenses

GAAP operating expenses

1,170,713

1,046,689

4,227,357

3,784,351

Less: Share-based compensation expenses

123,457

107,782

510,247

441,793

Less: Depreciation

30,943

30,957

117,946

124,231

Less: Amortization of intangibles

Adjusted operating expenses

1,016,291

907,933

3,599,097

3,218,232

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

GAAP income (loss) from operations

185,035

(79,425

)

447,136

(568,199

)

Plus: Share-based compensation expenses

123,457

107,782

510,247

441,793

Plus: Depreciation

34,417

49,046

131,615

166,938

Plus: Amortization of intangibles

1,567

1,200

10,071

4,824

Plus: Other

—

893

—

Adjusted income (loss) from operations

344,476

78,603

1,099,962

45,356

Reconciliation of GAAP to adjusted net income (loss):

GAAP net income (loss)

66,502

(151,881

)

286,933

(644,786

)

Plus: Share-based compensation expenses

123,457

107,782

510,247

441,793

Plus: Depreciation

34,417

49,046

131,615

166,938

Plus: Amortization of intangibles

1,567

1,200

10,071

4,824

Plus: Other

—

893

—

Plus: Impairment of equity investments

41,410

6,838

75,626

6,838

Plus: Discrete tax items

34,441

15,232

24,778

18,597

Plus: Income tax effect of non-GAAP adjustments

(76,815

)

(12,116

)

(122,562

)

(49,123

)

Adjusted net income (loss)

224,979

16,101

917,601

(54,919

)

Reconciliation of GAAP to adjusted EPS - basic

GAAP earnings (loss) per share - basic

0.05

(0.11

)

0.20

(0.47

)

Plus: Share-based compensation expenses

0.09

0.08

0.36

0.32

Plus: Depreciation

0.02

0.04

0.09

0.12

Plus: Amortization of intangibles

0.00

0.01

0.00

Plus: Other

0.00

Plus: Impairment of equity investments

0.03

0.00

0.05

0.00

Plus: Discrete tax items

0.02

0.01

0.02

0.01

Plus: Income tax effect of non-GAAP adjustments

(0.05

)

(0.01

)

(0.09

)

(0.04

)

Adjusted earnings (loss) per share - basic

0.16

0.01

0.65

(0.04

)

Reconciliation of GAAP to adjusted EPS - diluted

GAAP earnings (loss) per share - diluted

0.04

(0.11

)

0.19

(0.47

)

Plus: Share-based compensation expenses

0.08

0.35

0.32

Plus: Depreciation

0.02

0.03

0.09

0.12

Plus: Amortization of intangibles

0.00

0.01

0.00

Plus: Other

0.00

Plus: Impairment of equity investments

0.03

0.00

0.05

0.00

Plus: Discrete tax items

0.02

0.01

0.02

0.01

Plus: Income tax effect of non-GAAP adjustments

(0.05

)

(0.01

)

(0.08

)

(0.04

)

Adjusted earnings (loss) per share - diluted

0.15

0.01

0.62

(0.04

)

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

GAAP earnings (loss) per ADS - basic

0.60

(1.43

)

2.63

(6.12

)

Plus: Share-based compensation expenses

1.11

1.01

4.68

4.20

Plus: Depreciation

0.31

0.46

1.21

1.59

Plus: Amortization of intangibles

0.01

0.09

0.05

Plus: Other

0.00

0.01

0.00

Plus: Impairment of equity investments

0.37

0.06

0.69

0.06

Plus: Discrete tax items

0.31

0.14

0.23

0.18

Plus: Income tax effect of non-GAAP adjustments

(0.69

)

(0.11

)

(1.12

)

(0.47

)

Adjusted earnings (loss) per ADS - basic

2.03

0.15

8.41

(0.52

)

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

GAAP earnings (loss) per ADS - diluted 1

0.58

(1.39

)

2.53

(6.12

)

Plus: Share-based compensation expenses

1.07

0.98

4.50

4.20

Plus: Depreciation

0.30

0.45

1.16

1.59

Plus: Amortization of intangibles

0.01

0.09

0.05

Plus: Other

0.00

0.01

0.00

Plus: Impairment of equity investments

0.36

0.06

0.67

0.06

Plus: Discrete tax items

0.30

0.14

0.22

0.18

Plus: Income tax effect of non-GAAP adjustments

(0.67

)

(0.11

)

(1.08

)

(0.47

)

Adjusted earnings (loss) per ADS - diluted

1.95

0.15

8.09

(0.52

)

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.

2. For the fourth quarter of 2024, GAAP diluted loss per ADS includes $0.04 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.

Fourth Quarter

Full Year

2025

2024

2025

2024

Free Cash Flow (Non-GAAP)

Net cash provided by (used in) operating activities (GAAP)

417,347

75,160

1,127,580

(140,631

)

Less: Purchases of property, plant and equipment

(37,522

)

(92,480

)

(185,839

)

(492,663

)

Free Cash Flow (Non-GAAP)

379,825

(17,320

)

941,741

(633,294

)

Reconciliation of GAAP Operating Income Guidance to Non-GAAP

Operating Income Guidance for Full Year 2026

(Unaudited)

GAAP Operating Income

700,000

—

800,000

Plus: Adjustments to arrive at Non-GAAP 1

700,000

—

700,000

Non-GAAP Operating Income

1,400,000

—

1,500,000

1. The non-GAAP adjustments are based on best available information at this time related to non-cash items similar to those reported in our actual Non-GAAP results.