Arbutus Biopharma (ABUS) risk factors, FY2025 10-K

Arbutus Biopharma's FY2025 10-K, filed Mar 23, 2026, lists 41 risk factors in 4 groups. Against the prior year's 42: 4 new, 5 dropped, 13 substantially reworded.

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Risk factors listed
414 groups
New this year
4vs 42 last year
Dropped
5since the prior 10-K
Substantially reworded
13of those kept
Section length
16k wordsItem 1A

What the changes say

  • Moderna litigation and the potential $1.3 billion contingent payment now dominate the risk section.
  • Healthcare reimbursement, Medicaid pricing compliance, and healthcare-law enforcement risks are newly emphasized.
  • Pipeline, competitor, partner, and clinical-site risks were removed or narrowed, while ownership concentration fell from 44% to 38%.

What changed since the prior 10-K

New

  • NewRisks Related to Our Business, Our Financial Results and Need for Additional Capital

    We face risks associated with the Contingent Settlement Payment under the Moderna Settlement Agreement

    The contingent payment of up to $1.3 billion could be reduced or lost if the §1498 appeal fails or payment is delayed or disputed.

  • NewRisks Related to Our Business, Our Financial Results and Need for Additional Capital

    product for which we obtain marketing approval. If coverage and adequate reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize any product candidates that we develop

    Healthcare-law violations or reimbursement changes in the United States and Canada could trigger penalties, operating restrictions, and lower product profits.

  • NewRisks Related to Our Business, Our Financial Results and Need for Additional Capital

    programs. The risk of our being found in violation of these laws is increased by the fact that many of them are subject to evolving interpretation and application by courts and enforcement and regulatory authorities

    Errors in Medicaid Drug Rebate and other government pricing programs could require additional rebates, penalties, sanctions, or fines.

  • NewRisks Related to Our Intellectual Property

    proceedings, any of which could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline

    Patent, contract, or other biotechnology litigation could consume resources, divert management, and require licenses, royalties, or damages.

Dropped

  • DroppedRisks Related to Our Business, Our Financial Results and Need for Additional Capital

    Current and planned clinical trials may be impacted as a result of the military action by Russia in Ukraine

  • DroppedRisks Related to Our Business, Our Financial Results and Need for Additional Capital

    approvals of those product candidates in the United States and other countries. Many of our current and potential future competitors also have significantly more experience commercializing drugs that have been approved for marketing

  • DroppedRisks Related to Our Dependence on Third Parties

    We depend on Qilu for the development and commercialization of imdusiran in China, Hong Kong, Macau and Taiwan

  • DroppedRisks Related to Our Dependence on Third Parties

    partners or to which our present partners or any future partners have rights, may result in development delays or the withdrawal of their support for one or more of our product candidates

  • DroppedRisks Related to the Ownership of our Common Shares

    Our success depends on our new management team and Board of Directors, which is conducting a review of our pipeline and development plans for our hepatitis B programs

Reworded

  • 88% rewrittenRisks Related to Our Business, Our Financial Results and Need for Additional Capital

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

    The heading now directly emphasizes coverage and reimbursement risk; the underlying discussion of payor-by-payor coverage is unchanged.

  • 83% rewrittenRisks Related to Our Dependence on Third Parties

    If conflicts arise between our licensing partners and us, our licensing partners may act in their best interest and not in our best interest, which could adversely affect our business

    Qilu is no longer named, while disputes over development progress, milestones, royalties, and newly developed intellectual property are added.

    Was: If conflicts arise between our collaboration or licensing partners and us, our collaboration or licensing partners may act in their best interest and not in our best interest, which could adversely affect our business

  • 79% rewrittenRisks Related to Our Business, Our Financial Results and Need for Additional Capital

    We face significant competition from other biotechnology and pharmaceutical companies targeting HBV

    The competitor list changed, adding Mirum Pharmaceuticals and Precision Biosciences while removing Vir Biotechnology; the broader HBV competition warning remains.

  • 65% rewrittenRisks Related to the Ownership of our Common Shares

    We may form strategic alliances or collaborations that could harm our financial condition, results of operations or cash flows, dilute our shareholders’ ownership, incur debt or cause us to incur significant expense

    The risk no longer covers acquisitions or integration; it now emphasizes collaboration financing, debt or equity issuance, dilution, and uncertain access to capital.

    Was: We may acquire other assets or businesses, or form strategic alliances or collaborations or make investments in other companies or technologies that could harm our financial condition, results of operations or cash flows, dilute our shareholders’ ownership, incur debt or cause us to incur significant expense

  • 56% rewrittenRisks Related to the Ownership of our Common Shares

    The concentration of common share ownership will likely limit the ability of the other shareholders to influence corporate matters

    Reported ownership by insiders, major shareholders, and affiliates declined from approximately 44% as of March 25, 2025 to 38% as of March 18, 2026.

  • 48% rewrittenRisks Related to Our Intellectual Property

    Certain of our patents and patent applications have been challenged and found to be invalid, and additional challenges may occur in the future, which could adversely affect our business

    The patent-risk wording is substantively unchanged; only formatting around the listed risks was revised.

  • 48% rewrittenRisks Related to Our Business, Our Financial Results and Need for Additional Capital

    We are involved in patent infringement lawsuits to protect and assert our intellectual property rights against large, well-capitalized companies and the United States, which requires that we continue to expend substantial resources, and we may not be successful in these proceedings

    The litigation description now centers on Pfizer/BioNTech, a possible Moderna §1498 appeal, and a Court of Federal Claims lawsuit against the United States.

    Was: We are involved in multiple patent infringement lawsuits in multiple jurisdictions to protect and assert our intellectual property rights against large, well-capitalized companies, which requires that we continue to expend substantial resources, and we may not be successful in these proceedings

  • 40% rewrittenRisks Related to Our Business, Our Financial Results and Need for Additional Capital

    Several of our clinical trials are currently or were conducted outside the United States, and the FDA may not accept data from trials conducted in locations outside the United States

    The trial-location list narrowed to the United States, Moldova, Taiwan, South Korea, and Hong Kong, while FDA applicability to the U.S. population and medical practice was added.

    Was: Several of our current clinical trials are being conducted outside the United States, and the FDA may not accept data from trials conducted in locations outside the United States

  • 32% rewrittenRisks Related to Our Business, Our Financial Results and Need for Additional Capital

    Disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA, could prevent the FDA from performing normal functions on which our business relies, which could negatively impact our business

  • 29% rewrittenRisks Related to Our Business, Our Financial Results and Need for Additional Capital

    If we are unsuccessful in accomplishing these objectives, we may not be able to develop our product candidates, raise capital, expand our business or continue our operations

    Was: If we are unsuccessful in accomplishing these objectives, we may not be able to develop our product candidates, raise capital, expand our business or continue our operations. The approach we are taking to discover and develop novel product candidates is unproven and may never lead to marketable products

  • 25% rewrittenRisks Related to Our Business, Our Financial Results and Need for Additional Capital

    Even if our product candidates obtain regulatory approval, they will remain subject to ongoing regulatory requirements and oversight

  • 23% rewrittenRisks Related to the Ownership of our Common Shares

    Our business, reputation, and operations could suffer in the event of information technology system failures, such as a cybersecurity incident

  • 22% rewrittenRisks Related to the Ownership of our Common Shares

    We could face liability from our controlled use of hazardous and radioactive materials in our development processes

All 41 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business, Our Financial Results and Need for Additional Capital

  1. 01We are involved in patent infringement lawsuits to protect and assert our intellectual property rights against large, well-capitalized companies and the United States, which requires that we continue to expend substantial resources, and we may not be successful in these proceedings48% rewritten
  2. 02We face risks associated with the Contingent Settlement Payment under the Moderna Settlement AgreementNew
  3. 03We are in the early stages of our development, and there is a limited amount of information about us upon which you can evaluate our product candidates
  4. 04If we are unsuccessful in accomplishing these objectives, we may not be able to develop our product candidates, raise capital, expand our business or continue our operations29% rewritten
  5. 05We have incurred operating losses in nearly every year since our inception and we anticipate that we will not achieve operating profits for the foreseeable future. To date, we have had no product revenues
  6. 06We do not generate revenues from product sales and may never be profitable from operations
  7. 07Risks Related to Development, Clinical Testing, Regulatory Approval, Marketing, and Coverage and Reimbursement of our Product Candidates
  8. 08Our development programs are at an early stage of development. We must demonstrate our product candidates’ safety and efficacy in humans through extensive clinical testing, which is expensive and time-consuming and requires specialized knowledge and expertise
  9. 09Any of these occurrences may harm our business, financial condition, results of operations, cash flows and prospects significantly
  10. 10Because we have limited operational resources, we may decide to pursue a particular product candidate and fail to advance product candidates that later demonstrate a greater chance of clinical and commercial success
  11. 11Several of our clinical trials are currently or were conducted outside the United States, and the FDA may not accept data from trials conducted in locations outside the United States40% rewritten
  12. 12Before we can commercialize our product candidates in the United States, we must obtain approval from the FDA. We must similarly obtain approvals from comparable regulatory authorities to commercialize our product candidates in jurisdictions outside the United States
  13. 13Disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA, could prevent the FDA from performing normal functions on which our business relies, which could negatively impact our business32% rewritten
  14. 14If a particular product candidate causes undesirable side effects, then we may be unable to receive regulatory approval of or commercialize such product candidate
  15. 15Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing of our clinical trials depends in part on the speed at which we can recruit patients to participate in testing our product candidates
  16. 16It may take considerable time and expense to resolve the clinical hold that has been placed on our IND application of AB-101 by the FDA, and no assurance can be given that the FDA will remove the clinical hold, in which case our business and financial prospects may be adversely affected
  17. 17Even if our product candidates obtain regulatory approval, they will remain subject to ongoing regulatory requirements and oversight25% rewritten
  18. 18We face significant competition from other biotechnology and pharmaceutical companies targeting HBV79% rewritten
  19. 19Our ability to generate product revenues and become profitable from operations is largely dependent on the future commercial success of our HBV product candidates
  20. 20We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits
  21. 21Coverage and adequate reimbursement may not be available for our product candidates, which could make it difficult for us to sell our products profitably88% rewritten
  22. 22product for which we obtain marketing approval. If coverage and adequate reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize any product candidates that we developNew
  23. 23programs. The risk of our being found in violation of these laws is increased by the fact that many of them are subject to evolving interpretation and application by courts and enforcement and regulatory authoritiesNew
  24. 24Failure to comply with the United States Foreign Corrupt Practices Act (FCPA), and potentially other global anti-corruption and anti-bribery laws such as the Canadian Corruption of Foreign Public Officials Act, could subject us to penalties and other adverse consequences

Risks Related to Our Dependence on Third Parties

  1. 25We depend on our license agreement with Alnylam for the commercialization of ONPATTRO (Patisiran)
  2. 26ONPATTRO sales have declined each of the last three years due primarily to sales from Alnylam’s next generation RNAi product AMVUTTRA cannibalizing sales of ONPATTRO. If Alnylam’s sales of ONPATTRO continue to decline, the royalty entitlement may never revert back to us
  3. 27If conflicts arise between our licensing partners and us, our licensing partners may act in their best interest and not in our best interest, which could adversely affect our business83% rewritten
  4. 28We rely on third parties to conduct our clinical trials, and if they fail to fulfill their obligations, perform services in a satisfactory manner, and/or comply with applicable legal or regulatory requirements, our development plans may be adversely affected
  5. 29We rely exclusively on third parties to formulate and manufacture our product candidates, which exposes us to a number of risks that may delay development, regulatory approval and commercialization of our products or result in higher product costs

Risks Related to Our Intellectual Property

  1. 30Other companies or organizations may assert patent rights that prevent us from developing or commercializing our products
  2. 31Certain of our patents and patent applications have been challenged and found to be invalid, and additional challenges may occur in the future, which could adversely affect our business48% rewritten
  3. 32proceedings, any of which could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to declineNew
  4. 33Confidentiality agreements with employees and others, including collaborators, may not adequately prevent disclosure of trade secrets and other proprietary information

Risks Related to the Ownership of our Common Shares

  1. 34The concentration of common share ownership will likely limit the ability of the other shareholders to influence corporate matters56% rewritten
  2. 35Entities associated with Roivant Sciences Ltd. (Roivant) collectively held as a group approximately 20% of our outstanding common shares as of March 18, 2026
  3. 36We are incorporated in Canada, with our assets located both in Canada and the United States, with the result that it may be difficult for investors to enforce judgments obtained against us or some of our officers
  4. 37If we are deemed to be a “passive foreign investment company” for the current or any future taxable year, investors who are subject to United States federal taxation would likely suffer materially adverse United States federal income tax consequences
  5. 38Our articles and certain Canadian laws could delay or deter a change of control
  6. 39We could face liability from our controlled use of hazardous and radioactive materials in our development processes22% rewritten
  7. 40Our business, reputation, and operations could suffer in the event of information technology system failures, such as a cybersecurity incident23% rewritten
  8. 41We may form strategic alliances or collaborations that could harm our financial condition, results of operations or cash flows, dilute our shareholders’ ownership, incur debt or cause us to incur significant expense65% rewritten

Other Arbutus Biopharma 10-Ks

  • FY2024 10-K risk factors
    42 risks

    Arbutus Biopharma faces intense patent litigation with Moderna and Pfizer while undergoing major management turnover and a 57% workforce reduction. The company relies heavily on partners like Alnylam and Qilu while clinical development remains early-stage.

    Filed Mar 27, 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.