INSMED (INSM) risk factors, 2025 10-K

Other

1. 01The commercial success of ARIKAYCE depends on continued market acceptance by physicians, patients, third-party payors and others in the healthcare community and the commercial success of brensocatib, TPIP, or our other product candidates, if approved, will similarly depend on market acceptance
2. 02We remain subject to substantial, ongoing regulatory requirements, and failure to comply with these requirements could lead to enforcement action or otherwise materially harm our business
3. 03ARIKAYCE, brensocatib, TPIP, or our other product candidates could develop unexpected safety or efficacy concerns, which would likely have a material adverse effect on us
4. 04If estimates of the size of the potential markets for ARIKAYCE, brensocatib, TPIP, or our other product candidates are overstated or data we have used to identify physicians is inaccurate, our ability to earn revenue to support our business could be materially adversely affected
5. 05inaccurate. As a result, our estimates of the size of these potential markets for ARIKAYCE could prove to be overstated, perhaps materially
6. 06We may not be successful in clinical trials or in obtaining regulatory approvals required to expand the indication for ARIKAYCE, which may materially adversely affect our prospects and the value of our common stock

Risks Related to the Development and Regulatory Approval of Our Product Candidates Generally

1. 07Pharmaceutical research and development is very costly and highly uncertain, and we may not succeed in developing product candidates in the future
2. 08Such circumstances would impair our ability to commercialize our products and harm our business and results of operations
3. 09If another party obtains orphan drug exclusivity for a product that is considered the same or essentially the same as a product we are developing for a particular indication, we may be precluded or delayed from commercializing the product in that indication
4. 10used to carry the genetic material, which could adversely affect our ability to obtain and maintain regulatory approvals for and commercialize any gene therapy products we may develop

Risks Related to Our Reliance on Third Parties

1. 11These risks could materially harm our business, financial condition, results of operations and prospects and the value of our common stock
2. 12We may not have, or may be unable to obtain, sufficient quantities of ARIKAYCE, Lamira or our product candidates to meet our required supply for commercialization or clinical studies, which would materially harm our business
3. 13We do not have long-term commercial agreements with all of our suppliers and if any of our suppliers are unable or unwilling to perform for any reason, we may not be able to locate suppliers or enter into favorable agreements with them
4. 14The manufacturing facilities of our third-party manufacturers are subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we and our manufacturing partners fail to comply with the regulations or maintain the approvals

Risks Related to the Operation of our Business

1. 15We are dependent upon retaining and attracting key personnel, the loss of whose services could materially adversely affect our business, financial condition, results of operations and prospects and the value of our common stock
2. 16We expect to continue to expand our development, regulatory and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
3. 17Any acquisitions we make, or collaborative relationships we enter into, may not be clinically or commercially successful, and may require financing or a significant amount of cash, which could adversely affect our business
4. 18We may be subject to product liability claims, and we have only limited product liability insurance
5. 19We are subject to data privacy laws and regulations that govern how we can collect, process, store, and transfer personal data, and violations can result in meaningful penalties, enforcement, and/or reputational harm and have a significant impact on our operations
6. 20Our inability to access, upgrade or expand our technology systems or difficulties in updating our existing technology or developing or implementing new technology could have a material adverse effect on our business or results of operations
7. 21We have limited experience operating internationally, are subject to a number of risks associated with our international activities and operations and may not be successful in our efforts to expand internationally
8. 22We operate in a highly competitive and changing environment, and if we are unable to adapt to our environment, we may be unable to compete successfully
9. 23We have a limited number of significant customers and losing any of them could have an adverse effect on our financial condition and results of operations
10. 24Deterioration in general economic conditions in the United States, Europe, Japan and globally, including the effect of prolonged periods of inflation on our suppliers, third-party service providers and potential partners, could harm our business and results of operations
11. 25The emergence of a pandemic, and efforts to reduce its spread, could negatively impact our business and operations
12. 26Our current and potential future use of artificial intelligence (AI) and machine learning may not be successful and presents new risks and challenges to our business

Risks Related to Our Intellectual Property

1. 27If we are unable to protect our intellectual property rights adequately, the value of ARIKAYCE and our product candidates could be materially diminished
2. 28If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of ARIKAYCE and our product candidates could be materially diminished
3. 29We may not be able to enforce our intellectual property rights throughout the world, which could harm our business

Risks Related to Government Regulation

1. 30Government healthcare reform could materially increase our costs, which could materially adversely affect our business, financial condition, results of operations and prospects and the value of our common stock
2. 31Our industry is highly regulated and changes in or revisions to laws and regulations that make gaining regulatory approval, reimbursement and pricing more difficult or subject to different criteria and standards may adversely impact our business, operations or financial results
3. 32Our research, development and manufacturing activities used in the production of ARIKAYCE and our product candidates involve the use of hazardous materials, which could expose us to damages, fines, penalties and sanctions and materially adversely affect our results of operations and financial condition

Risks Related to Our Financial Condition and Need for Additional Capital

1. 33We have a history of operating losses, expect to incur operating losses for the foreseeable future and may never achieve or maintain profitability
2. 34We may need to raise additional funds to continue our operations, and any failure to obtain capital when needed on acceptable terms, or at all, could force us to delay, reduce, or eliminate our development programs, commercialization efforts or other operations
3. 35We may be unable to use certain of our net operating losses and other tax assets
4. 36Changes in our effective income tax rate and future changes to US and non-US tax laws could adversely affect our results of operations
5. 37We have recorded a significant amount of goodwill on our consolidated balance sheet as a result of acquisitions. We review the recoverability of goodwill annually and whenever events or circumstances indicate that the carrying value of a reporting unit may not be recoverable

Risks Related to Ownership of Our Common Stock

1. 38Our shareholders may experience dilution of their ownership interests because of the future issuance of additional shares of our common stock for general corporate purposes and upon the conversion of the 2028 Convertible Notes
2. 39The market price of our stock has been and may continue to be highly volatile, which could lead to shareholder litigation against us
3. 40Certain provisions of Virginia law, our articles of incorporation and amended and restated bylaws and arrangements between us and our employees could hamper a third party’s acquisition of us or discourage a third party from attempting to acquire control of us