8-K
BeOne Medicines Ltd. (ONC)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________
Form 8-K
_________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): February 26, 2026
BEONE MEDICINES LTD.
(Exact Name of Registrant as Specified in Charter)
| Switzerland | 001-37686 | 98-1209416 |
|---|---|---|
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) |
c/o BeOne Medicines I GmbHAeschengraben 27
Basel 4051Switzerland
(Address of Principal Executive Offices) (Zip Code)
+41 61 685 19 00
(Registrant's telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| American Depositary Shares, each representing 13 Ordinary Shares, par value $0.0001 per share | ONC | The Nasdaq Global Select Market |
| Ordinary Shares, par value $0.0001 per share* | 06160 | The Stock Exchange of Hong Kong Limited |
*Included in connection with the registration of the American Depositary Shares with the Securities and Exchange Commission. The ordinary shares are not listed for trading in the United States but are listed for trading on The Stock Exchange of Hong Kong Limited.
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 2.02. Results of Operations and Financial Condition.
On February 26, 2026, BeOne Medicines Ltd. (the “Company”) announced its financial results for the three months and year ended December 31, 2025. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description |
|---|---|
| 99.1 | Press release titled “BeOne Medicines Announces Fourth Quarter and Full Year 2025 Financial Results, Highlighting Global Success of BRUKINSA and Foundational Oncology Leadership”, issued by BeOne Medicines Ltd. on February 26, 2026 |
| 104 | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL |
The portions of the press release set forth under Item 2.02 of this Current Report on Form 8-K are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such filing.
Exhibit Index
| Exhibit No. | Description |
|---|---|
| 99.1 | Press release titled “BeOne MedicinesAnnounces Fourth Quarter and Full Year 2025Financial Results, Highlighting Global Success of BRUKINSA and Foundational Oncology Leadership”, issued by BeOne MedicinesLtd. on February26, 2026 |
| 104 | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BEONE MEDICINES LTD. | ||
|---|---|---|
| Date: February 26, 2026 | By: | /s/ Chan Lee |
| Name: | Chan Lee | |
| Title: | Senior Vice President, General Counsel |
Document
| Exhibit 99.1 |
|---|
BeOne Medicines Announces Fourth Quarter and Full Year 2025 Financial Results, Highlighting Global Success of BRUKINSA and Foundational Oncology Leadership
•Total global revenues of $1.5 billion and $5.3 billion for the fourth quarter and full year, increases of 33% and 40% from the prior-year periods
•Global BRUKINSA (zanubrutinib) revenues of $1.1 billion and $3.9 billion for the fourth quarter and full year, increases of 38% and 49% from the prior-year periods
•Diluted GAAP Earnings per American Depository Share (ADS) of $0.58 and $2.53 for the fourth quarter and full year; non-GAAP diluted Earnings per ADS of $1.95 and $8.09 for the fourth quarter and full year
•Full year 2026 total revenue guidance of $6.2 billion to $6.4 billion
SAN CARLOS, Calif. – February 26, 2026 – 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 | 32 | % | $ | 5,282,061 | $ | 3,779,546 | 40 | % |
| Other revenue | $ | 21,728 | $ | 9,789 | 122 | % | $ | 60,972 | $ | 30,695 | 99 | % |
| Total revenue | $ | 1,498,170 | $ | 1,127,824 | 33 | % | $ | 5,343,033 | $ | 3,810,241 | 40 | % |
| 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.
| Exhibit 99.1 |
|---|
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.
•BRUKINSA: Global sales totaled $1.1 billion and $3.9 billion the fourth quarter and full year of 2025, representing growth of 38% and 49%, compared to the prior-year periods; U.S. sales of BRUKINSA totaled $845 million and $2.8 billion in the fourth quarter and full year of 2025, representing growth of 37% and 45%, compared to the prior-year periods.
•TEVIMBRA (tislelizumab): Global sales totaled $182 million and $737 million, in the fourth quarter and full year of 2025, representing growth of 18% and 19%, compared to the prior-year periods.
•Amgen in-licensed products: Global sales totaled $112 million and $486 million for the fourth quarter and full year of 2025, representing growth of 11% and 33%, compared to 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 | 14 | % | $ | 544,823 | $ | 474,874 | 15 | % |
| Selling, general and administrative | $ | 555,290 | $ | 504,677 | 10 | % | $ | 471,468 | $ | 433,059 | 9 | % |
| Total operating expenses | $ | 1,170,713 | $ | 1,046,689 | 12 | % | $ | 1,016,291 | $ | 907,933 | 12 | % |
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 | 10 | % | $ | 1,855,979 | $ | 1,668,368 | 11 | % |
| Selling, general and administrative | $ | 2,081,489 | $ | 1,831,056 | 14 | % | $ | 1,743,118 | $ | 1,549,864 | 12 | % |
| Total operating expenses | $ | 4,227,357 | $ | 3,784,351 | 12 | % | $ | 3,599,097 | $ | 3,218,232 | 12 | % |
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.
| Exhibit 99.1 |
|---|
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 20261 | |
|---|---|
| Total revenue | $6.2 - $6.4 billion |
| GAAP gross margin % | High-80% range |
| GAAP operating expenses2<br><br>(combined R&D and SG&A) | $4.7 - $4.9 billion |
| GAAP operating income2 | $700 - $800 million |
| Non-GAAP operating income2,3 | $1.4 - $1.5 billion |
1Assumes January 1, 2026 foreign exchange rates.
2Does not assume any potential new, material business development activity or unusual/non-recurring items.
3Non-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:
•Other income (expense): estimated range of $25 million to $50 million in expense, includes interest amortization from Royalty Pharma arrangement.
•Income tax outlook: earnings may provide sufficient positive evidence to reverse certain valuation allowances in 2026, resulting in a material tax benefit when recognized; the timing and magnitude of a potential reversal is uncertain; prior to reversal, income tax expense should trend with earnings per historical relationship.
•Diluted ADS outstanding: the Company expects diluted ADSs outstanding of approximately 118 million.
Fourth Quarter Business Highlights
Core Marketed Products
BRUKINSA (zanubrutinib)
•Presented 6-year landmark results from the Phase 3 SEQUOIA trial and long-term results from the Phase 3 ALPINE trial at the American Society of Hematology (ASH) Annual Meeting, confirming sustained benefit for the treatment of adult patients with treatment-naïve (TN) and relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), respectively.
| Exhibit 99.1 |
|---|
Sonrotoclax (BCL2 inhibitor)
•Received first global approvals in China for the treatment of adult patients with:
◦R/R mantle cell lymphoma (MCL) who have received at least two systemic therapies, including a Bruton tyrosine kinase (BTK) inhibitor;
◦and R/R CLL/SLL who have previously received at least one systemic therapy, including a BTK inhibitor.
•Granted U.S. Food and Drug Administration (FDA) priority review for the treatment of adult patients with R/R MCL.
•Submitted Marketing Authorization Application in the European Union for the treatment of adult patients with R/R MCL.
•Enrolled first subject in Phase 3 trial in combination with BRUKINSA as a fixed-duration regimen versus acalabrutinib plus venetoclax for the treatment of adult patients with TN CLL.
TEVIMBRA (tislelizumab)
•Presented full results in partnership with Jazz Pharmaceuticals and Zymeworks from the HERIZON-GEA-01 trial in combination with ZIIHERA (zanidatamab) and chemotherapy, demonstrating statistically significant and clinically meaningful improvement in overall survival versus trastuzumab plus chemotherapy for the first-line treatment of adult patients with HER2-positive gastroesophageal adenocarcinoma (GEA).
Select Clinical-Stage Programs
Hematology
•BGB-16673 (BTK chimeric degradation activation compound (CDAC)): Presented results at ASH from the Phase 1 CaDAnCe-101 trial for the treatment of adult patients with R/R CLL.
Breast and Gynecologic Cancers
•BG-75202 (KAT6A/B inhibitor): Initiated first in human study.
•BG-75908 (CDK2 CDAC): Initiated first in human study.
Lung Cancer
•BG-C0902 (EGFRxMETxMET antibody-drug conjugate): Initiated first in human study.
Gastrointestinal Cancers
•BGB-B2033 (GPC3x41BB bispecific antibody): Granted FDA Fast Track Designation for the treatment of adult patients with hepatocellular carcinoma who experience disease progression on or after post-systemic therapy.
| Exhibit 99.1 |
|---|
Anticipated R&D Milestones
| Programs | Milestones | Timing | ||
|---|---|---|---|---|
| BRUKINSA | •Phase 3 MANGROVE trial interim analysis in combination with rituximab versus bendustamine plus rituximab for the treatment of adult patients with first-line MCL. | 1H 2026 | ||
| TEVIMBRA | •Supplemental Biologics License Application submissions in U.S. and China for the treatment of adult patients with first-line HER2-positive GEA in combination with zanidatamab. | 1H 2026 | ||
| •Japan regulatory approval for the treatment of adult patients with first-line gastric cancer. | 2H 2026 | |||
| Hematology | •Sonrotoclax (BCL2 inhibitor): | |||
| ◦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 | |||
| •BGB-16673 (BTK CDAC): | ||||
| ◦Phase 2 potential accelerated approval submission (if data support) for the treatment of adult patients with R/R CLL. | 2H 2026 | |||
| Breast/Gynecologic Cancers | •BGB-43395 (CDK4 inhibitor): | |||
| ◦Phase 3 trial initiation for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer. | 1H 2026 | |||
| Gastrointestinal Cancers | •BGB-B2033 (GPC3x41BB bispecific antibody): | |||
| ◦Potentially registrational Phase 2 trial initiation. | 2H 2026 | |||
| Inflammation and Immunology | •BGB-45035 (IRAK4 CDAC): | |||
| ◦Phase 1/2 trial data readout for the treatment of adult patients with rheumatoid arthritis. | 2H 2026 | |||
| •BGB-16673 (BTK CDAC): | ||||
| ◦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.
| Exhibit 99.1 |
|---|
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.
| Investor Contact | Media Contact |
|---|---|
| Liza Heapes | Kyle Blankenship |
| +1 857-302-5663 | +1 667-351-5176 |
| ir@beonemed.com | media@beonemed.com |
| Exhibit 99.1 | |
| --- |
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 | ||||
| Exhibit 99.1 | ||||||||
| --- |
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 |
| Exhibit 99.1 | ||||
| --- |
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 |
| Exhibit 99.1 | ||||||||
| --- |
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.
| Exhibit 99.1 |
|---|
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 | 22 | 17 | 67 | 95 | ||||||
| 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 | 22 | 17 | 67 | 95 | ||||||
| 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 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) | ||
| Exhibit 99.1 | ||||||||||
| --- | Fourth Quarter | Full Year | ||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | ||
| 2025 | 2024 | 2025 | 2024 | |||||||
| 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 | 0.00 | 0.01 | 0.00 | ||||||
| Plus: Other | 0.00 | 0.00 | 0.00 | 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 | 0.08 | 0.35 | 0.32 | ||||||
| Plus: Depreciation | 0.02 | 0.03 | 0.09 | 0.12 | ||||||
| Plus: Amortization of intangibles | 0.00 | 0.00 | 0.01 | 0.00 | ||||||
| Plus: Other | 0.00 | 0.00 | 0.00 | 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 | 0.01 | 0.09 | 0.05 | ||||||
| Plus: Other | 0.00 | 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 - diluted1 | $ | 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 | 0.01 | 0.09 | 0.05 | ||||||
| Plus: Other | 0.00 | 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.
| Exhibit 99.1 | | --- || | 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-GAAP1 | 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.