Alkermes (ALKS) risk factors, FY2024 10-K

Risks Related to Our Business and Our Industry

1. 01We receive substantial revenue from our key proprietary products and our success depends on our ability to successfully manufacture and commercialize such products
2. 02We face competition in the biopharmaceutical industry
3. 03Our revenues from sales of our products may decrease or grow at a slower than expected rate due to many factors
4. 04any other material adverse developments with respect to the commercialization of our products
5. 05If there are changes in, or we fail to comply with, the extensive legal and regulatory requirements affecting the healthcare industry, we could be subject to investigations, litigation, costs, penalties and business losses
6. 06We rely heavily on our licensees in the commercialization and continued development of products from which we receive revenue and, if our licensees are not effective, or if disputes arise in respect of our contractual arrangements, our revenues could be materially adversely affected
7. 07Clinical trials for our products are expensive, may take several years to complete, and their outcomes are uncertain
8. 08unforeseen governmental or regulatory issues or concerns, including those of the FDA and other regulatory agencies, that may impact the strategies for, and design, timelines or feasibility of, our clinical development programs
9. 09Our success depends, in part, on our ability to successfully obtain and maintain regulatory approval for our products
10. 10regulatory agencies may change their requirements for approval or post-approval marketing; and
11. 11In addition, disruptions at the FDA and other regulatory agencies that are unrelated to our company or our products, including those relating to a prolonged U.S. government shutdown, or other global, political or economic conditions, could cause delays to the regulatory approval process for our products
12. 12Disruptions at the FDA, the SEC and other government agencies could negatively impact our business
13. 13We may not be able to successfully expand our R&D pipeline or our commercial product portfolio, which could limit our growth potential
14. 14We are subject to risks related to the manufacture of our products
15. 15We rely on third parties to provide goods and services in connection with the manufacture and distribution of the products we manufacture
16. 16If we or our third-party providers fail to meet the stringent requirements of governmental regulation in the manufacture of our products, we could incur substantial remedial costs and experience a reduction in sales and/or revenues
17. 17Our success largely depends upon our ability to attract, recognize and retain key personnel

Risks Related to Intellectual Property

1. 18Patent and other IP protection for our products is key to our business and our competitive position but is uncertain
2. 19Uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers

Risks Related to Regulatory or Legal Matters

1. 20The clinical study or commercial use of our products may cause unintended side effects or adverse reactions, or incidents of misuse may occur, which could adversely affect our products, business and share price
2. 21We participate in the Medicaid Drug Rebate Program, the 340B program, the U.S. Department of Veterans Affairs’ FSS pricing program, and the Tricare program, and have obligations to report the average sales price for certain of our drugs to the Medicare program
3. 22Our business involves environmental, health and safety risks

Risks Related to our Financial Condition and Tax Matters

1. 23We may not be able to maintain profitability on a sustained basis
2. 24resolve favorably any commercial disputes that may arise in respect of collaborative arrangements from which we receive revenues
3. 25We have broad discretion regarding use of our cash and cash equivalents and we may not allocate our cash in ways that ultimately increase the value of our ordinary shares
4. 26If goodwill becomes impaired, we may have to take significant charges against earnings
5. 27Our effective tax rate may increase
6. 28Changes in tax rules and regulations, or interpretations thereof, may adversely affect our financial condition
7. 29Our deferred tax assets may not be realized
8. 30The disposition of the Athlone Facility may limit our ability to use our net operating losses and result in unanticipated tax liabilities
9. 31The IRS may not agree with our conclusion that we should be treated as a foreign corporation for U.S. federal income tax purposes
10. 32If the separation of our oncology business completed in November 2023 does not ultimately qualify as a transaction that is generally tax-free for U.S. federal and Irish tax purposes as we anticipate, we and/or our shareholders could be subject to significant tax liabilities
11. 33Our business strategy may involve future transactions which may harm the market price of our ordinary shares or require us to seek additional funds, and such funding may not be available on commercially favorable terms or at all and may cause dilution to our existing shareholders
12. 34limited by the terms of new share issuance authorities approved by our shareholders, our ability to use our authorized but unissued share capital to effect or to fund acquisition or other transaction opportunities, or to otherwise raise capital, could be adversely affected
13. 35Currency exchange rates may affect revenues and expenses

Risks Related to our Ordinary Shares

1. 36The market price of our ordinary shares has been volatile and may continue to be volatile in the future, and could decline significantly
2. 37Our business could be negatively affected as a result of the actions of activist shareholders

Risks Related to Information Security and Data Privacy

1. 38Information security breaches and other disruptions could compromise our information and expose us to liability, which would cause our business and reputation to suffer
2. 39We may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational damage
3. 40A future pandemic, epidemic or outbreak of an infectious disease, may materially and adversely affect our business, financial condition and results of operations
4. 41If we identify a material weakness in our internal control over financial reporting, our ability to meet our reporting obligations and the trading price of our ordinary shares could be negatively affected
5. 42The increasing use of social media platforms and artificial intelligence tools present new risks and challenges