Company: ABUS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001447028-25-000083
Chunk: 78

Company: Arbutus Biopharma Corp
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 78
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 to enroll patients in our clinical trials, which could hinder such clinical trials.

•It 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.

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

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

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

•We are largely dependent on the future commercial success of our HBV product candidates.

•We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.  

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

•We are subject to United States and Canadian healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages and reputational harm. 

•If we participate in the Medicaid Drug Rebate Program and other governmental pricing programs, failure to comply with obligations under these programs could result in additional reimbursement requirements, penalties, sanctions and 

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fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

•Failure to comply with the United States Foreign Corrupt Practices Act, and potentially other similar global laws could subject us to penalties and other adverse consequences.

Risks Related to Our Dependence on Third Parties

•We depend on our license agreement with Alnylam Pharmaceuticals, Inc. for the commercialization of ONPATTRO™ (Patisiran). 

•We expect to depend in part on our licensing agreements for a significant portion of our revenues for the foreseeable future and to develop, conduct clinical trials with, obtain regulatory approvals for, and manufacture, market and sell some of our product candidates. If these licensing agreements are unsuccessful, or anticipated milestone or royalty payments are not received, our business could be materially adversely affected.

•We depend on Qilu Pharmaceutical Co., Ltd. for the development and commercialization of imdusiran in China, Hong Kong, Macau and Taiwan.

•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