BeOne Medicines (ONC) risk factors, FY2025 10-K

Risks Related to Clinical Development and Commercialization of Our Medicines and Drug Candidates

1. 01Our medicines may fail to achieve and maintain the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community necessary for commercial success
2. 02We have limited experience in launching and marketing our internally developed and in-licensed medicines
3. 03We face substantial competition, which may result in others discovering, developing, or commercializing competing medicines before or more successfully than we do
4. 04The market opportunities for our future medicines may be limited to those patients who are ineligible for or have failed prior treatments and may be small
5. 05If we or any third parties with which we may collaborate to market and sell our medicines are unable to achieve and maintain coverage and adequate levels of reimbursement or are subject to unfavorable pricing regulations, our commercial success and business operations could be adversely affected27% rewritten
6. 06We have operations in the U.S., China, Europe, and other markets and plan to expand in these and new markets on our own or with collaborators, which exposes us to risks of conducting business in international markets48% rewritten
7. 07The illegal distribution and sale by third parties of counterfeit versions of our medicines or stolen products could have a negative impact on our reputation and business
8. 08Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results
9. 09If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected

Risks Related to Regulatory Approval and Extensive Government Regulation

1. 10All material aspects of the research, development, manufacturing and commercialization of pharmaceutical products are heavily regulated, and we may face difficulties in complying with or be unable to comply with such regulations, which could have a material adverse effect on our business
2. 11We may be subject to anti-kickback, false claims laws, physician payment transparency laws, fraud and abuse laws or similar healthcare and security laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished sales45% rewritten
3. 12Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models could impact our product revenues and materially harm our businessNew
4. 13The approval processes of regulatory authorities in the U.S., China, Europe and other comparable regulatory authorities are lengthy, time consuming, costly, and inherently unpredictableNew
5. 14We are currently conducting and may in the future conduct clinical trials for our drug candidates outside the U.S., and the FDA and comparable foreign regulatory authorities may not accept data from such trials
6. 15Undesirable adverse events caused by our medicines and drug candidates could interrupt, delay or halt clinical trials, delay or prevent regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any regulatory approval
7. 16If safety, efficacy, or other issues arise with any medical product that is used in combination with our medicines, we may be unable to market such medicine or may experience significant regulatory delays or supply shortages, and our business could be materially harmed
8. 17Recently enacted and future legislation and regulations may increase the difficulty and cost for us to obtain regulatory approval of and commercialize our medicines and drug candidates and affect the prices we may obtain33% rewritten

Risks Related to Our Financial Position and Need for Additional Capital

1. 18We have historically incurred significant net losses and may incur net losses in the future24% rewritten
2. 19We may need to obtain additional financing to fund our operations, and if we are unable to obtain such financing, we may be unable to complete the development of our drug candidates or achieve profitability35% rewritten
3. 20Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our technologies or drug candidates
4. 21Fluctuations in exchange rates could result in foreign currency exchange losses and could materially reduce the value of your investment
5. 22Failure to meet responsible business and sustainability expectations or standards or achieve our corporate strategy goals could adversely affect our business, results of operations, financial condition or stock price

Risks Related to Our Intellectual Property

1. 23If we are unable to obtain and maintain patent protection for our medicines and drug candidates, we may lose market exclusivities in our medicines
2. 24Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects25% rewritten
3. 25Lawsuits alleging infringing of intellectual property rights of third parties could be costly and time consuming and could prevent or delay us from developing or commercializing our medicines or drug candidates27% rewritten
4. 26If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed. We may also be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of others

Risks Related to Our Reliance on Third Parties

1. 27We rely on third parties to manufacture some of our commercial and clinical drug supplies
2. 28For example, in March 2020, the NMPA suspended the importation, sales and use of ABRAXANE in China previously supplied to us by BMS, and the drug was subsequently recalled by BMS. This suspension was based on inspection findings at BMS’s contract manufacturing facility in the U.S
3. 29We have entered into licensing and collaboration arrangements and may enter into additional collaborations, licensing arrangements, or strategic alliances in the future, and we may not realize the benefits of such arrangements
4. 30If we fail to maintain an effective distribution channel for our medicines, our business and sales could be adversely affected
5. 31If we are not able to successfully develop and/or commercialize Amgen’s oncology products, the expected benefits of the collaboration will not materialize

Risks Related to Our Industry, Business and Operations

1. 32We have significantly increased and expect to continue to increase our research, development, manufacturing, and commercial capabilities, and we may experience difficulties in managing our growth
2. 33Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
3. 34Our business is subject to complex and evolving industry-specific laws and regulations regarding the collection and transfer of personal data
4. 35We manufacture some of our medicines and intend to manufacture some of our drug candidates, if approved
5. 36If we engage in acquisitions or strategic collaborations, this may increase our capital requirements, dilute our shareholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks
6. 37If we fail to comply with the U.S. Foreign Corrupt Practices Act or other anti-bribery and corruption laws, our reputation may be harmed and we could be subject to penalties and significant expenses that have a material adverse effect on our business, financial condition and results of operations
7. 38If we or our CROs or contract manufacturing organizations (“CMOs”) fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business
8. 39Our information technology systems, or those used by our contractors or collaborators, may fail or suffer security breaches, which could result in a material disruption of our product development and commercialization efforts
9. 40The increasing use of artificial intelligence-based software (including machine learning) and social media platforms may result in reputational harm or liability or could otherwise adversely affect our business38% rewritten
10. 41Our failure to comply with privacy and data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results
11. 42If we or the parties on whom we rely fail to maintain the necessary licenses for the development, manufacture, sale and distribution of our products, our ability to conduct our business could be materially impaired
12. 43Our financial and operating performance may be adversely affected by government shutdowns, public health crises, natural catastrophes, or other business interruptions outside of our control21% rewritten
13. 44Climate change manifesting as physical or transition risks, included related environmental regulation, could have a material adverse impact on our business operations, clients and customers
14. 45Product liability claims or lawsuits could cause us to incur substantial liabilities
15. 46We are subject to the risks and challenges of doing business globally, which may adversely affect our business operations53% rewritten
16. 47Future operating results could be negatively affected by changes in tax rates, the adoption of new tax legislation in the jurisdictions in which we operate, or exposure to additional tax liabilities74% rewritten
17. 48Restrictive covenants in our facilities agreements may limit our ability to respond to changes in market conditions or pursue business opportunitiesNew
18. 49We may not be able to generate sufficient cash to service all of our indebtedness and may be forced to take other actions to satisfy our obligations under applicable debt instruments, which may not be successfulNew

Risks Related to Our Doing Business in the PRC

1. 50Historically, there has been legislation implemented which put our ADSs at risk of potential delisting. The delisting of our ADSs, or the threat of their being delisted, may materially and adversely affect the value of your investment
2. 51There are uncertainties regarding the interpretation and enforcement of Chinese laws, rules and regulations, and rules and regulations in China can change quickly with little advance notice
3. 52PRC regulations establish complex procedures for some acquisitions conducted by foreign investors, which could make it more difficult for us to pursue growth through acquisitions in China
4. 53We may rely on dividends and other distributions on equity paid by our PRC subsidiaries to fund any cash and financing requirements we may have, and any limitation on the ability of our PRC subsidiaries to make payments to us could have a material and adverse effect on our ability to conduct our business
5. 54Our PRC subsidiaries generate primarily all of their revenue in RMB, which is not freely convertible into other currencies. As a result, any restriction on currency exchange may limit the ability of our PRC subsidiaries to use their RMB revenues to pay dividends to us
6. 55We may be treated as a resident enterprise for PRC tax purposes under the EIT Law and we may therefore be subject to PRC income tax on our worldwide taxable income. Dividends payable to foreign investors and gains on the sale of our ADSs or ordinary shares by our foreign investors may become subject to PRC tax
7. 56We and our shareholders face uncertainties with respect to indirect transfers of equity interests in PRC resident enterprises or other assets attributed to a PRC establishment of a non-PRC company, or other assets attributable to a PRC establishment of a non-PRC company
8. 57Regulations on currency exchange may limit our ability to utilize our revenue effectively
9. 58Our business benefits from certain financial incentives and discretionary policies granted by local governments. Expiration of, or changes to, these incentives or policies would have an adverse effect on our results of operations
10. 59Any failure to comply with PRC regulations regarding our employee equity plans and investments in offshore companies by PRC residents may subject the PRC plan participants and PRC-resident beneficial owners or us to fines and other legal or administrative sanctions
11. 60The pharmaceutical industry in China is highly regulated, and such regulations are subject to change, which may affect approval and commercialization of our medicines and drug candidates

Risks Related to Our Ordinary Shares, ADSs, and RMB Shares

1. 61The trading prices of our ordinary shares, ADSs, and/or RMB Shares can be volatile, which could result in substantial losses to you
2. 62The characteristics of capital markets in the U.S., Hong Kong and Shanghai are different, which may cause volatility in the market price of our ordinary shares, ADSs, and RMB Shares
3. 63We may be subject to securities litigation, which is expensive and could divert management attention
4. 64Future sales of our ordinary shares, ADSs, and/or RMB Shares in the public market could cause the ordinary share, ADS, and/or RMB Share price to fall
5. 65As of February 13, 2026, 1,442,259,810 ordinary shares, par value $0.0001 per share, were outstanding, of which 714,971,127 ordinary shares were held in the form of 54,997,779 ADSs, each representing 13 ordinary shares, and 115,055,260 were RMB Shares23% rewritten
6. 66The triple listing of our ADSs, ordinary shares and RMB Shares may adversely affect the liquidity and value of our ADSs, ordinary shares and/or RMB Shares and lead to increased compliance obligations and costs22% rewritten
7. 67Because we do not expect to pay dividends in the foreseeable future, you must rely on price appreciation of the ordinary shares, ADSs and/or RMB Shares for return on your investment57% rewritten
8. 68If securities or industry analysts do not continue to publish research, or publish inaccurate or unfavorable research about our business, the market price for the ordinary shares, ADSs and/or RMB Shares and trading volume could decline44% rewritten
9. 69We are now a corporation (Aktiengesellschaft) organized under Swiss law. Our corporate affairs are governed by Swiss Articles, our organizational regulations (as may be amended from time to time), and the laws of Switzerland, in particular the Swiss Code of Obligations (Obligationenrecht)New
10. 70As we are a Swiss company, our shareholders may face difficulties in enforcing their interestsNew
11. 71Anti-takeover provisions in our constitutional documents may discourage our acquisition by a third party, which could limit our shareholders’ opportunity to sell their shares at a premium94% rewritten
12. 72Our Swiss Articles designate specific courts as the exclusive forum for certain disputes initiated by our shareholders, which could limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us, our directors, officers, or other employeesNew
13. 73Holders of ADSs may be subject to limitations on transfer of their ADSs
14. 74The depositary for the ADSs is entitled to charge holders fees for various services, including annual service fees
15. 75Dealings in ordinary shares registered in our Hong Kong register of members will be subject to Hong Kong stamp duty. There is uncertainty as to whether Hong Kong stamp duty will apply to the trading or conversion of the ADSs
16. 76Holders of ADSs may not receive distributions on our ordinary shares or any value for them if it is illegal or impractical to make them available
17. 77Holders of ADSs may not be able to participate in rights offerings and may experience dilution of their holdings
18. 78We may be a passive foreign investment company in future taxable years, which may have adverse U.S. federal income tax consequences for U.S. shareholders
19. 79If you are a “Ten Percent Shareholder,” you may be subject to adverse U.S. federal income tax consequences if we are classified as a Controlled Foreign Corporation

Risks Related to Our Continuation to Switzerland

1. 80Your rights as a shareholder changed following the Continuation54% rewritten
2. 81As a Swiss corporation, our flexibility will be limited with respect to certain aspects of capital managementNew
3. 82The Continuation has resulted in and may continue to result in additional direct costs70% rewritten
4. 83If you fail to make a required tax filing, the Continuation could result in adverse tax consequences for you42% rewritten
5. 84You may be subject to Swiss withholding taxes on the payment of dividends50% rewritten