Roivant Sciences (ROIV) risk factors, FY2026 10-K

Roivant Sciences's FY2026 10-K, filed May 20, 2026, lists 98 risk factors in 7 groups. Against the prior year's 102: 18 new, 22 dropped, 33 substantially reworded.

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Risk factors listed
987 groups
New this year
18vs 102 last year
Dropped
22since the prior 10-K
Substantially reworded
33of those kept
Section length
61k wordsItem 1A

What the changes say

  • Foreign-CMO restrictions, including the BIOSECURE Act, could disrupt manufacturing, supply chains and clinical programs.

What changed since the prior 10-K

New

  • NewRisks Related to Our Strategy and Financial Position

    Immunovant relies on the HanAll Agreement to provide the rights to the core intellectual property relating to IMVT-1402 and batoclimab. Any termination or loss of significant rights under the HanAll Agreement could adversely affect Immunovant’s development or commercialization of IMVT-1402

  • NewRisks Related to Our Strategy and Financial Position

    If the business or development of a product candidate at one of these Vants were to face challenges, we would be adversely affected as a result and would be limited in our ability to cause or influence the Vant in question to take appropriate remediative actions

  • NewRisks Related to Our Strategy and Financial Position

    Changes in tariffs and other governmental trade policies could negatively affect our business and results of operations

  • NewRisks Related to Our Strategy and Financial Position

    negative impact on our commercial sales. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which economic climate and financial market conditions could adversely impact our business

  • NewRisks Related to Our Strategy and Financial Position

    While we do not have a need for additional capital under our current operating plans as a result of our current liquidity position, we may face risks in the future relating to the need for additional capital to fund our operations

  • NewRisks Related to Our Strategy and Financial Position

    Legislation targeting biotechnology companies with ties to certain foreign adversaries, including the BIOSECURE Act, could materially adversely affect our business, supply chain and results of operations

  • NewRisks Related to Our Strategy and Financial Position

    In such an event, we or our Vants may be required to transition manufacturing activities then performed by CMOs receiving the designation to alternative CMOs, which could be costly, time-consuming and disruptive to our supply chain and clinical development programs

  • NewRisks Related to the Development of Our Product Candidates

    programs. There can also be no assurance that the results of studies conducted by collaborators or other third parties with similar product candidates in similar indications will be viewed favorably or indicative of our own future trial results

  • NewRisks Related to the Development of Our Product Candidates

    competitors in this same class of drugs may impair our ability to enroll patients into our clinical trials, delaying or potentially preventing us from completing recruitment of one or more of our trials

  • NewRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    Regulatory authorities in some jurisdictions, including the U.S., the U.K. and the European Economic Area (the “EEA”), may designate drugs and biologics for relatively small patient populations as orphan drugs that can benefit from orphan drug market exclusivities when approved if certain conditions are met

  • NewRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to significant and abrupt change, including due to judicial challenges, election cycles and resulting regulatory updates and changes in policy priorities

  • NewRisks Related to Our Reliance on Third Parties

    Other Risks Related to Our Business and Industry

  • NewRisks Related to Our Reliance on Third Parties

    expectations and such companies’ stated privacy policies, notices or other representations. Particularly because the FTC has taken these actions based on theories that are not codified in regulations, the risk of such an action is difficult to quantify and to mitigate

  • NewRisks Related to Our Reliance on Third Parties

    Cross-border transfers of personal data and compliance with international data protection regulations, including the GDPR, create legal and operational risks for our business

  • NewRisks Related to Our Reliance on Third Parties

    Compliance with FDA electronic records and data integrity requirements creates cybersecurity-adjacent regulatory risk that could adversely affect our business

  • NewRisks Related to Our Intellectual Property

    as to the rights in related or resulting know-how and inventions, which could be time-consuming and divert the attention of senior management

  • NewRisks Related to Our Intellectual Property

    the disputes between GSG and Arbutus, on the one hand, and Moderna and its affiliates, on the other, and does not affect other pending litigation, including the Pfizer Action described below, which remains ongoing and subject to its own risks and uncertainties

  • NewRisks Related to Our Intellectual Property

    manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants

Dropped

  • DroppedRisks Related to Our Strategy and Financial Position

    continue to meet the requirements of being a public company, including requirements under the Sarbanes-Oxley Act of 2002 (“SOX”) and continue to protect our business operations and systems from cybersecurity threats

  • DroppedRisks Related to Our Strategy and Financial Position

    the loss of key employees and other uncertainties, including our ability to maintain key business relationships at the acquired entity, that may arise in connection with a given transaction

    Public-company compliance, cybersecurity, development milestones and related timing and expense uncertainties.

  • DroppedRisks Related to Our Strategy and Financial Position

    Our drug discovery efforts may not be successful in identifying new product candidates

  • DroppedRisks Related to the Development of Our Product Candidates

    other regulatory issues, including the receipt of any inspectional observations on FDA’s Form-483, Warning or Untitled Letters, clinical holds or complete response letters or similar communications/objections by other regulatory authorities

  • DroppedRisks Related to the Development of Our Product Candidates

    the risk that patients enrolled in clinical trials will not complete such trials, for any reason, including the risk of higher drop-out rates if participants become infected with a virus or other infectious disease that impacts their participation in our trials

  • DroppedRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    the FDA or other relevant regulatory authorities may change their approval policies or adopt new regulations

  • DroppedRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    our reputation may suffer

  • DroppedRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    FDA approval for a product candidate in the United States does not guarantee that we will be able to or that we will make efforts to obtain approval for or commercialize our product candidates in any other jurisdiction, which would limit our ability to realize the product candidate’s full market potential

  • DroppedRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    cultivating a proactive, preventative quality culture and employee and supplier training to ensure quality

    Acquisition integration or separation, key employee and relationship losses, and alliance or joint-venture execution problems.

  • DroppedRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    safety and the prevalence and severity of any side effects or adverse events

  • DroppedRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    unforeseen costs and expenses associated with creating an independent commercialization organization

  • DroppedRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    the amount of taxes that we are required to pay

  • DroppedRisks Related to Our Reliance on Third Parties

    failure to deliver our product candidates under specified storage conditions and in a timely manner

    Failure of Psivant, Covant or VantAI to discover new candidates using computational and other approaches.

  • DroppedRisks Related to Our Reliance on Third Parties

    Tyvaso (treprostinil), a prostacyclin mimetic, a potential competitor to mosliciguat

  • DroppedRisks Related to Our Reliance on Third Parties

    We may not hold a controlling stake in certain of our Vant affiliates and thus may not be able to direct our business or the development of our product candidates

  • DroppedRisks Related to Our Intellectual Property

    the priority of invention of patented technology

  • DroppedRisks Related to Our Intellectual Property

    Switzerland: filing a case, seeking a permanent injunction and monetary relief, which upon later choice of GSG and Arbutus can include surrender of profits, damages or a reasonable royalty, for infringement of EP 2 279 254

  • DroppedRisks Related to Our Intellectual Property

    UPC: Case 10284/2025, seeking permanent and provisional injunctions, as well as monetary damages, which can include recovery of Moderna’s unfair profits, for infringement of EP 4 241 767

    Clinical-trial suspensions and regulatory actions such as Form 483 observations, warning letters, clinical holds and complete response letters.

  • DroppedRisks Related to Our Securities, Our Jurisdiction of Incorporation and Certain Tax Matters

    general economic and political conditions such as recessions, interest rates, tariffs and trade conditions in the global economy, commodity prices, international currency fluctuations and acts of war or terrorism

  • DroppedRisks Related to Our Securities, Our Jurisdiction of Incorporation and Certain Tax Matters

    We have incurred and will continue to incur increased costs as a result of operating as a public company and our management has devoted and will continue to devote a substantial amount of time to new compliance initiatives

    Patient trial dropouts, including those caused by viral or infectious disease, reducing retention and delaying studies.

  • DroppedRisks Related to Our Securities, Our Jurisdiction of Incorporation and Certain Tax Matters

    requiring advance notice for shareholder proposals and nominations and placing limitations on convening shareholder meetings

  • DroppedRisks Related to Our Securities, Our Jurisdiction of Incorporation and Certain Tax Matters

    Our largest shareholders own a significant percentage of our common shares and are able to exert significant control over matters subject to shareholder approval

Reworded

  • 95% rewrittenRisks Related to Our Reliance on Third Parties

    Any of these risks, if encountered, could significantly harm our future international expansion and operations and, consequently, negatively impact our financial condition, results of operations and cash flows

    The text is substantively unchanged; punctuation and list formatting were streamlined.

  • 92% rewrittenRisks Related to Our Intellectual Property

    If we are unable to protect the confidentiality of any trade secrets, our business and competitive position would be harmed

    The confidentiality-protection discussion is shortened in the provided text after listing contract manufacturers and other parties with access.

  • 91% rewrittenRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    Our failure to maintain or continuously improve our quality management program could have an adverse effect upon our business, subject us to regulatory actions and cause patients to lose confidence in us or our product candidates, among other negative consequences

    Quality examples are reformatted into bullets, with Good Laboratory Practices and Good Manufacturing Practices spelled out.

  • 90% rewrittenRisks Related to Our Intellectual Property

    We may be involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful

    The Moderna Action now refers to certain patents and omits patent numbers 8,058,069 and 8,822,668 from the example.

  • 85% rewrittenRisks Related to Our Strategy and Financial Position

    We are exposed to risks related to our significant holdings of cash, cash equivalents and marketable securities

    The discussion removes detailed market-stress examples and adds risks to fixed-income security value and liquidity from interest rates and issuer credit.

  • 80% rewrittenRisks Related to Our Strategy and Financial Position

    Unfavorable, uncertain and rapidly changing global and regional economic, political and public health conditions could adversely affect our business, financial condition and results of operations

    The cost-pass-through example now specifically concerns raising prices of approved product candidates, rather than passing expenses to customers generally.

    Was: Unfavorable, uncertain and rapidly changing global and regional economic, political and health conditions could adversely affect our business, financial condition or results of operations

  • 72% rewrittenRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    Any future commercialization efforts will be dependent on sales, marketing and distribution capabilities, including agreements with third parties to sell, market and distribute our product candidates

    Immunovant, Priovant and Pulomvant are now building focused commercial infrastructure rather than having none, and will need patient-support organizations.

  • 71% rewrittenRisks Related to the Development of Our Product Candidates

    We may encounter difficulties enrolling and retaining patients in clinical trials and clinical development activities could thereby be delayed or otherwise adversely affected

    Enrollment and retention examples are reformatted into bullets, retaining biomarker-driven eligibility and trial-design constraints.

    Was: We may encounter difficulties enrolling and retaining patients in clinical trials, and clinical development activities could thereby be delayed or otherwise be adversely affected

  • 63% rewrittenRisks Related to Our Reliance on Third Parties

    The markets in which our healthcare technology and computational drug discovery Vants participate are competitive and our drug discovery efforts may not be successful in identifying new product candidates. If we do not compete effectively, our business and operating results could be adversely affected

    Was: The markets in which our healthcare technology and computational drug discovery Vants participate are competitive, and if we do not compete effectively, our business and operating results could be adversely affected

  • 58% rewrittenRisks Related to Our Intellectual Property

    Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated as a result of non-compliance with these requirements

  • 58% rewrittenRisks Related to Our Reliance on Third Parties

    We may be dependent on one or a limited number of suppliers for certain components of our product candidates

  • 56% rewrittenRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, delay or prevent their regulatory approval, limit the scope of any approved label or market acceptance following regulatory approval or result in significant negative consequences

  • 55% rewrittenRisks Related to Our Securities, Our Jurisdiction of Incorporation and Certain Tax Matters

    Anti-takeover provisions in our memorandum of association and bye-laws, as well as provisions of Bermuda law, could delay or prevent a change in control, limit the price investors may be willing to pay in the future for our common shares and could entrench management

  • 53% rewrittenRisks Related to Our Strategy and Financial Position

    We face risks associated with the Vant structure

  • 53% rewrittenRisks Related to Our Reliance on Third Parties

    The use of AI could expose us to liability or adversely affect our business

  • 47% rewrittenRisks Related to Our Strategy and Financial Position

    We face risks associated with the use of our cash, cash equivalents and marketable securities

  • 45% rewrittenRisks Related to Our Strategy and Financial Position

    Our relatively limited operating history and the inherent uncertainties and risks involved in biopharmaceutical product development and commercialization may make it difficult for us to execute on our business model and for you to assess our future prospects

  • 45% rewrittenRisks Related to the Development of Our Product Candidates

    Clinical trials and preclinical studies are very expensive, time-consuming, difficult to design and implement and involve uncertain outcomes. We may encounter substantial delays in clinical trials, or may not be able to conduct or complete clinical trials or preclinical studies on the expected timelines, if at all

  • 45% rewrittenRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    Healthcare legislative and regulatory measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations

  • 43% rewrittenRisks Related to Our Intellectual Property

    Third-party claims or litigation alleging infringement, misappropriation or other violations of third-party patents or other proprietary rights or seeking to invalidate our patents or other proprietary rights, may delay or prevent the development and commercialization of our product candidates

  • 41% rewrittenRisks Related to Our Strategy and Financial Position

    We face risks associated with acquisitions, divestitures and other strategic transactions

  • 41% rewrittenRisks Related to Our Securities, Our Jurisdiction of Incorporation and Certain Tax Matters

    Changes in our effective tax rate may reduce our net income in future periods

  • 39% rewrittenRisks Related to Our Securities, Our Jurisdiction of Incorporation and Certain Tax Matters

    Future sales and issuances of our or the Vants’ equity securities or rights to purchase equity securities, including pursuant to our or the Vants’ equity incentive and other compensatory plans, will result in additional dilution of the percentage ownership of our shareholders and could cause our share price to fall

  • 36% rewrittenRisks Related to Our Strategy and Financial Position

    A portion of our or certain of our Vants’ manufacturing, laboratory research or clinical trial activities takes place in Asia. A significant disruption in that region, such as a trade war or political unrest, could materially adversely affect our business, financial condition and results of operations

  • 36% rewrittenRisks Related to Our Securities, Our Jurisdiction of Incorporation and Certain Tax Matters

    If our performance does not meet market expectations, the price of our securities may decline

  • 34% rewrittenRisks Related to Our Securities, Our Jurisdiction of Incorporation and Certain Tax Matters

    The intended tax effects of our corporate structure and intercompany arrangements depend on the application of the tax laws of various jurisdictions and on how we operate our business

  • 29% rewrittenRisks Related to Our Strategy and Financial Position

    We face risks associated with potential future payments we may owe in connection with our product candidates

  • 29% rewrittenRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    Coverage and adequate reimbursement may not be available for our product candidates following regulatory approval, which could make it difficult for us to profitably sell our product candidates

  • 29% rewrittenRisks Related to Our Intellectual Property

    The use of AI by us, our early-stage discovery Vants and our healthcare technology businesses may introduce intellectual property risks

  • 29% rewrittenRisks Related to Our Reliance on Third Parties

    We do not have our own manufacturing capabilities and rely on third parties to produce clinical and commercial supplies of our product candidates

  • 28% rewrittenRisks Related to Our Strategy and Financial Position

    We will likely incur significant operating losses for the foreseeable future and may never achieve sustained profitability

  • 24% rewrittenRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    Receipt of marketing approval for our product candidates does not guarantee that they will achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success

  • 22% rewrittenRisks Related to Regulatory Approval and Commercialization of Our Product Candidates

    Following regulatory approvals, our products will remain subject to extensive regulatory scrutiny

All 98 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Strategy and Financial Position

  1. 01Our relatively limited operating history and the inherent uncertainties and risks involved in biopharmaceutical product development and commercialization may make it difficult for us to execute on our business model and for you to assess our future prospects45% rewritten
  2. 02We may not be successful in our efforts to acquire or in-license new product candidates, and newly acquired or in-licensed product candidates may not perform as expected in clinical trials or be successful in eventually achieving marketing approvals
  3. 03We will likely incur significant operating losses for the foreseeable future and may never achieve sustained profitability28% rewritten
  4. 04Immunovant relies on the HanAll Agreement to provide the rights to the core intellectual property relating to IMVT-1402 and batoclimab. Any termination or loss of significant rights under the HanAll Agreement could adversely affect Immunovant’s development or commercialization of IMVT-1402New
  5. 05We face risks associated with the allocation of capital and personnel across our businesses
  6. 06We face risks associated with the Vant structure53% rewritten
  7. 07If the business or development of a product candidate at one of these Vants were to face challenges, we would be adversely affected as a result and would be limited in our ability to cause or influence the Vant in question to take appropriate remediative actionsNew
  8. 08We face risks associated with potential future payments we may owe in connection with our product candidates29% rewritten
  9. 09Changes in tariffs and other governmental trade policies could negatively affect our business and results of operationsNew
  10. 10Unfavorable, uncertain and rapidly changing global and regional economic, political and public health conditions could adversely affect our business, financial condition and results of operations80% rewritten
  11. 11negative impact on our commercial sales. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which economic climate and financial market conditions could adversely impact our businessNew
  12. 12We face risks associated with acquisitions, divestitures and other strategic transactions41% rewritten
  13. 13We face risks associated with the use of our cash, cash equivalents and marketable securities47% rewritten
  14. 14We are exposed to risks related to our significant holdings of cash, cash equivalents and marketable securities85% rewritten
  15. 15While we do not have a need for additional capital under our current operating plans as a result of our current liquidity position, we may face risks in the future relating to the need for additional capital to fund our operationsNew
  16. 16Our business strategy and potential for future growth rely on a number of assumptions, some or all of which may not be realized
  17. 17Inadequate or uncertain funding levels for the FDA, USPTO, SEC or other government agencies, including from government shut downs or significant changes in leadership personnel or policies, could hinder, delay or result in the suspension of those agencies’ operations, which could harm our business
  18. 18A portion of our or certain of our Vants’ manufacturing, laboratory research or clinical trial activities takes place in Asia. A significant disruption in that region, such as a trade war or political unrest, could materially adversely affect our business, financial condition and results of operations36% rewritten
  19. 19Legislation targeting biotechnology companies with ties to certain foreign adversaries, including the BIOSECURE Act, could materially adversely affect our business, supply chain and results of operationsNew
  20. 20In such an event, we or our Vants may be required to transition manufacturing activities then performed by CMOs receiving the designation to alternative CMOs, which could be costly, time-consuming and disruptive to our supply chain and clinical development programsNew

Risks Related to the Development of Our Product Candidates

  1. 21Clinical trials and preclinical studies are very expensive, time-consuming, difficult to design and implement and involve uncertain outcomes. We may encounter substantial delays in clinical trials, or may not be able to conduct or complete clinical trials or preclinical studies on the expected timelines, if at all45% rewritten
  2. 22programs. There can also be no assurance that the results of studies conducted by collaborators or other third parties with similar product candidates in similar indications will be viewed favorably or indicative of our own future trial resultsNew
  3. 23The results of our preclinical studies and clinical trials may not support our proposed claims for our product candidates or regulatory approvals on a timely basis or at all, and the results of earlier studies and trials may not be predictive of future trial results
  4. 24From time to time, we may publicly disclose interim, preliminary or topline data from our clinical trials, which are based on a preliminary analysis of then-available data. These results and related findings and conclusions are subject to change following a full analysis of all data related to the particular trial
  5. 25We may encounter difficulties enrolling and retaining patients in clinical trials and clinical development activities could thereby be delayed or otherwise adversely affected71% rewritten
  6. 26competitors in this same class of drugs may impair our ability to enroll patients into our clinical trials, delaying or potentially preventing us from completing recruitment of one or more of our trialsNew
  7. 27Changes in methods of product candidate manufacturing or formulation may result in additional costs or delays

Risks Related to Regulatory Approval and Commercialization of Our Product Candidates

  1. 28Our clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of product candidates that we may identify and pursue for their intended uses, which would prevent, delay or limit the scope of regulatory approval and commercialization
  2. 29Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, delay or prevent their regulatory approval, limit the scope of any approved label or market acceptance following regulatory approval or result in significant negative consequences56% rewritten
  3. 30Following regulatory approvals, our products will remain subject to extensive regulatory scrutiny22% rewritten
  4. 31We may develop product candidates for the treatment of conditions for which there is little clinical experience and, in some cases, use new endpoints or methodologies, and the FDA or other regulatory authorities may not consider the endpoints of these clinical trials to provide clinically meaningful results
  5. 32Our failure to maintain or continuously improve our quality management program could have an adverse effect upon our business, subject us to regulatory actions and cause patients to lose confidence in us or our product candidates, among other negative consequences91% rewritten
  6. 33Regulatory authorities in some jurisdictions, including the U.S., the U.K. and the European Economic Area (the “EEA”), may designate drugs and biologics for relatively small patient populations as orphan drugs that can benefit from orphan drug market exclusivities when approved if certain conditions are metNew
  7. 34Receipt of marketing approval for our product candidates does not guarantee that they will achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success24% rewritten
  8. 35If approved, our product candidates regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway
  9. 36Any future commercialization efforts will be dependent on sales, marketing and distribution capabilities, including agreements with third parties to sell, market and distribute our product candidates72% rewritten
  10. 37Coverage and adequate reimbursement may not be available for our product candidates following regulatory approval, which could make it difficult for us to profitably sell our product candidates29% rewritten
  11. 38Healthcare legislative and regulatory measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations45% rewritten
  12. 39Our current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient support, charitable organizations, customers and others are subject to applicable healthcare regulatory laws, which could expose us to penalties and other risks
  13. 40Recent federal legislation and actions by state and local governments may permit reimportation of drugs from foreign countries into the United States, including foreign countries where the drugs are sold at lower prices than in the United States, which could materially adversely affect our operating results
  14. 41The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to significant and abrupt change, including due to judicial challenges, election cycles and resulting regulatory updates and changes in policy prioritiesNew

Risks Related to Our Reliance on Third Parties

  1. 42We rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner or fail to comply with applicable requirements, it may harm our business
  2. 43We do not have our own manufacturing capabilities and rely on third parties to produce clinical and commercial supplies of our product candidates29% rewritten
  3. 44If the contract manufacturing facilities on which we rely do not continue to meet regulatory requirements or are unable to meet our requirements, including providing an adequate supply, our business will be harmed
  4. 45We may be dependent on one or a limited number of suppliers for certain components of our product candidates58% rewritten
  5. 46Certain of our product candidates are novel, complex and difficult to manufacture. We could experience manufacturing problems that result in delays in our development or commercialization programs or otherwise harm our business
  6. 47We are subject to operational risks associated with the physical and digital infrastructure at the manufacturing facilities that our external service providers utilize
  7. 48Other Risks Related to Our Business and IndustryNew
  8. 49We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy
  9. 50We will need to expand our organization and may experience difficulties in managing this growth, which could disrupt operations
  10. 51Our international operations may expose us to business, legal, regulatory, political, operational, financial and economic risks associated with conducting business globally
  11. 52Any of these risks, if encountered, could significantly harm our future international expansion and operations and, consequently, negatively impact our financial condition, results of operations and cash flows95% rewritten
  12. 53expectations and such companies’ stated privacy policies, notices or other representations. Particularly because the FTC has taken these actions based on theories that are not codified in regulations, the risk of such an action is difficult to quantify and to mitigateNew
  13. 54The use of AI could expose us to liability or adversely affect our business53% rewritten
  14. 55The markets in which our healthcare technology and computational drug discovery Vants participate are competitive and our drug discovery efforts may not be successful in identifying new product candidates. If we do not compete effectively, our business and operating results could be adversely affected63% rewritten
  15. 56Cross-border transfers of personal data and compliance with international data protection regulations, including the GDPR, create legal and operational risks for our businessNew
  16. 57Compliance with FDA electronic records and data integrity requirements creates cybersecurity-adjacent regulatory risk that could adversely affect our businessNew
  17. 58If product liability claims are brought against us, we may incur substantial liabilities, delay our planned or ongoing clinical trials and limit commercialization of our product candidates following regulatory approval
  18. 59If we or any contract manufacturers or suppliers we engage fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business
  19. 60We or the third parties upon whom we depend may be adversely affected by earthquakes, hurricanes, fires, outbreak of disease or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
  20. 61The increasing use of social media platforms presents new risks and challenges

Risks Related to Our Intellectual Property

  1. 62If we are unable to obtain and maintain patent and other intellectual property protection for our technology and product candidates, or if the scope of the intellectual property protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets
  2. 63The length of our patent terms may be inadequate to protect the competitive position of our product candidates for an adequate amount of time
  3. 64If we do not obtain protection under the Hatch-Waxman Amendments by extending the patent term, our business may be harmed
  4. 65Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated as a result of non-compliance with these requirements58% rewritten
  5. 66Third-party claims or litigation alleging infringement, misappropriation or other violations of third-party patents or other proprietary rights or seeking to invalidate our patents or other proprietary rights, may delay or prevent the development and commercialization of our product candidates43% rewritten
  6. 67as to the rights in related or resulting know-how and inventions, which could be time-consuming and divert the attention of senior managementNew
  7. 68We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might harm our ability to develop and, following regulatory approvals, market our product candidates
  8. 69We may be involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful90% rewritten
  9. 70the disputes between GSG and Arbutus, on the one hand, and Moderna and its affiliates, on the other, and does not affect other pending litigation, including the Pfizer Action described below, which remains ongoing and subject to its own risks and uncertaintiesNew
  10. 71Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
  11. 72The validity, scope and enforceability of any patents listed in the Orange Book that cover our product candidates or patents that cover our biologic product candidates can be challenged by third parties
  12. 73We may not be able to protect our intellectual property rights throughout the world
  13. 74If we are unable to protect the confidentiality of any trade secrets, our business and competitive position would be harmed92% rewritten
  14. 75manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultantsNew
  15. 76We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties
  16. 77We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
  17. 78Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities, and have a harmful effect on the success of our business
  18. 79The use of AI by us, our early-stage discovery Vants and our healthcare technology businesses may introduce intellectual property risks29% rewritten
  19. 80We may not be successful in obtaining necessary intellectual property rights to future product candidates through acquisitions and in-licenses
  20. 81Any trademarks we have obtained or may obtain may be infringed or successfully challenged, resulting in harm to our business
  21. 82Intellectual property rights do not necessarily address all potential threats to our competitive advantage
  22. 83Certain software utilized in our computational drug discovery efforts may include third-party open source software. Any failure to comply with the terms of one or more open source software licenses could adversely affect our business, subject us to litigation or create potential liability

Risks Related to Our Securities, Our Jurisdiction of Incorporation and Certain Tax Matters

  1. 84If our performance does not meet market expectations, the price of our securities may decline36% rewritten
  2. 85If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common shares may decline
  3. 86Future sales and issuances of our or the Vants’ equity securities or rights to purchase equity securities, including pursuant to our or the Vants’ equity incentive and other compensatory plans, will result in additional dilution of the percentage ownership of our shareholders and could cause our share price to fall39% rewritten
  4. 87Future sales, or the perception of future sales, of our common shares by us or our existing shareholders could cause the market price for our common shares to decline and impact our ability to raise capital in the future
  5. 88If securities analysts publish negative evaluations of our shares, the price of our common shares could decline
  6. 89Because there are no plans to pay cash dividends on our common shares for the foreseeable future, you may not receive any return on investment unless you sell our common shares for a price greater than that which you paid for it
  7. 90Anti-takeover provisions in our memorandum of association and bye-laws, as well as provisions of Bermuda law, could delay or prevent a change in control, limit the price investors may be willing to pay in the future for our common shares and could entrench management55% rewritten
  8. 91We are an exempted company limited by shares incorporated under the laws of Bermuda and it may be difficult for you to enforce judgments against us or our directors and executive officers
  9. 92Bermuda law differs from the laws in effect in the U.S. and may afford less protection to our shareholders
  10. 93There are regulatory limitations on the ownership and transfer of our common shares
  11. 94We may become subject to unanticipated tax liabilities and higher effective tax rates
  12. 95The intended tax effects of our corporate structure and intercompany arrangements depend on the application of the tax laws of various jurisdictions and on how we operate our business34% rewritten
  13. 96Changes in our effective tax rate may reduce our net income in future periods41% rewritten
  14. 97U.S. holders of our common shares may suffer adverse tax consequences if we are characterized as a passive foreign investment company
  15. 98Based on the foregoing, with respect to the taxable year that ended on March 31, 2026, we believe that we were not a PFIC based in part upon the fair market value of our assets, including any goodwill and intangible property and the nature and composition of our income and assets

Other Roivant Sciences 10-Ks

  • FY2025 10-K risk factors
    102 risks

    Roivant Sciences is a clinical-stage biopharmaceutical company with a unique Vant business structure and limited operating history. Key risks involve clinical trial uncertainty, reliance on product acquisitions and licensing, regulatory compliance, and extensive capital allocation. The company holds significant cash and marketable securities subject to macroeconomic conditions.

    Filed May 29, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.