BeOne Medicines Ltd.
For the period ended Dec 31, 2025. Filed Feb 26, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Feb 26, 2026
Extracted filing text, with the paragraph anchors used by the comparison.
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Table of Contents
Annual Report on Form 10‑K
TABLE OF CONTENTS
| Page | ||
|---|---|---|
| PART I | ||
| Item 1. | Business | 3 |
| Item 1A. | Risk Factors | 59 |
| Item 1B. | Unresolved Staff Comments | 118 |
| Item 1C. | Cybersecurity | 118 |
| Item 2. | Properties | 120 |
| Item 3. | Legal Proceedings | 120 |
| Item 4. | Mine Safety Disclosures | 120 |
| PART II | ||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 121 |
| Item 6. | Reserved | 125 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 126 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 139 |
| Item 8. | Financial Statements and Supplementary Data | 141 |
| Item 9. | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure | 197 |
| Item 9A. | Controls and Procedures | 197 |
| Item 9B. | Other Information | 198 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 198 |
| PART III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance | 199 |
| Item 11. | Executive Compensation | 199 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 199 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 199 |
| Item 14. | Principal Accountant Fees and Services | 199 |
| PART IV | ||
| Item 15. | Exhibits and Financial Statement Schedules | 200 |
| Item 16. | Form 10‑K Summary | 206 |
| SIGNATURES | ||
Forward‑Looking Statements and Market Data
This Annual Report on Form 10‑K (the “Annual Report”) contains forward‑looking statements that involve substantial risks and uncertainties. These forward-looking statements are based on management’s current expectations and projections about future events and trends that may affect the business, financial condition, and operating results. All statements other than statements of historical facts contained in this Annual Report, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected growth, are forward‑looking statements. Forward-looking statements often include words such as, but not limited to, “aim,” “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would” or the negative of these terms or similar expressions. These forward‑looking statements include, among other things, statements about:
our ability to successfully commercialize our approved medicines and to obtain approvals in additional indications and territories for our medicines;
the timing, progress and results of our research and development (“R&D”) programs, preclinical studies and clinical trials of our drug candidates, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work and the period during which the results of the trials will become available;
ourability to successfully develop and commercialize our in-licensed medicines and drug candidates and any other medicines and drug candidates we may in-license;
ourability to further develop sales and marketing capabilities and launch and commercialize new medicines, if approved;
ourability to maintain and expand regulatory approvals for our medicines and drug candidates, if approved;
the pricing and reimbursement of our medicines and drug candidates, if approved;
our ability to advance our drug candidates into, and successfully complete, clinical trials and obtain regulatory approvals;
our reliance on the success of our clinical stage drug candidates;
our plans, expected milestones and the timing or likelihood of regulatory filings and approvals;
the implementation of our business model, strategic plans for our business, medicines, drug candidates and technology;
the scope of protection we (or our licensors) are able to establish and maintain for intellectual property rights covering our medicines, drug candidates and technology;
our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights and proprietary technology of third parties;
costs associated with enforcing or defending against intellectual property infringement, misappropriation or violation, product liability and other claims;
the regulatory environment and regulatory developments in the United States (“U.S.”), China, the United Kingdom (“UK”), Switzerland, the European Union (“EU”) and other jurisdictions in which we operate;
the accuracy of our estimates regarding expenses, revenues, including collaboration revenue, capital requirements and our need for additional financing;
the potential benefits of strategic collaboration and licensing agreements and our ability to enter into and maintain strategic arrangements;
our construction and operation of independent production facilities for small molecule medicines and large molecule biologics, as well as clinical R&D facilities, to support the global demand for both commercial and clinical supply;
our reliance on third parties to conduct drug development, manufacturing and other services;
our ability to manufacture and supply, or have manufactured and supplied, drug candidates for clinical development and medicines for commercial sale;
the rate and degree of market access and acceptance of our medicines and drug candidates, if approved;
developments relating to our competitors and our industry, including competing therapies;
the size of the potential markets for our medicines and drug candidates and our ability to serve those markets;
our ability to effectively manage our growth;
our ability to attract and retain qualified employees and key personnel;
our ability to comply with the covenants and other requirements under our facilities agreements and to borrow available amounts under such agreements;
statements regarding future revenue, key milestones, expenses, capital expenditures, capital requirements and share performance;
the future trading price of our American Depositary Shares (“ADSs”) listed on Nasdaq, our ordinary shares listed on HKEx, and our ordinary shares issued to permitted investors in China and listed and traded on the STAR in Renminbi (“RMB Shares”), as well as the impact of securities analysts’ reports on these prices; and
the effects of our redomiciliation to Switzerland, including its tax treatment, and our name change in 2025.
These statements involve risks and uncertainties, including those that are described in “Item 1A. Risk Factors” of this Annual Report, that may cause actual future events or results to differ materially from those expected. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
We do not assume any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by applicable law.
This Annual Report includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. 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.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.