Alkermes (ALKS) risk factors, FY2025 10-K

Alkermes's FY2025 10-K, filed Feb 25, 2026, lists 43 risk factors in 6 groups. Against the prior year's 42: 4 new, 3 dropped, 11 substantially reworded.

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Risk factors listed
436 groups
New this year
4vs 42 last year
Dropped
3since the prior 10-K
Substantially reworded
11of those kept
Section length
21k wordsItem 1A

What the changes say

  • Integration risks and $1.525 billion debt from the Avadel acquisition dominate the updated risk factors.
  • Global trade and tariff policies are added as a new external supply chain threat.

What changed since the prior 10-K

New

  • NewRisks Related to Our Business and Our Industry

    We may fail to realize some or all of the anticipated benefits and synergies of the Avadel Acquisition or to successfully integrate Avadel’s business, which could adversely affect our business and financial condition and the price of our ordinary shares

    We may fail to successfully integrate Avadel’s business and systems or realize anticipated synergies following our February 2026 acquisition.

  • NewRisks Related to our Financial Condition and Tax Matters

    Our debt obligations could adversely affect our business and limit our ability to plan for or respond to changes in our business

    We incurred $1.525 billion in debt under a Credit Agreement for the Avadel acquisition, increasing our financial leverage and interest rate exposure.

  • NewRisks Related to our Financial Condition and Tax Matters

    placing us at a competitive disadvantage compared to our less leveraged competitors

    The Credit Agreement imposes strict leverage and coverage ratios and asset liens, which could lead to defaults if our operating results decline.

  • NewRisks Related to Information Security and Data Privacy

    Changes in global trade or other policies, including tariffs or other restrictions imposed by the U.S. government or governments of other nations, could have an adverse effect on our business, results of operations, or financial condition

    Global trade policies and tariffs since April 2025 could impact international materials in our supply chain and manufacturing elements for LUMRYZ.

Dropped

  • DroppedRisks Related to Our Business and Our Industry

    regulatory agencies may change their requirements for approval or post-approval marketing; and

  • DroppedRisks Related to Our Business and Our Industry

    In 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

  • DroppedRisks Related to our Financial Condition and Tax Matters

    limited 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

Reworded

  • 59% rewrittenRisks Related to Our Business and Our Industry

    Our success depends, in part, on our ability to successfully obtain and maintain regulatory approval for our products

    Added the DEA alongside the FDA as a regulatory authority governing controlled substances.

  • 55% rewrittenRisks Related to Our Business and Our Industry

    If 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

    Added explicit mention of DEA and state-level agency regulation and unannounced inspections for controlled substances.

  • 46% rewrittenRisks Related to our Financial Condition and Tax Matters

    Changes in tax rules and regulations, or interpretations thereof, may adversely affect our financial condition

    Updated to note that the EU minimum corporate tax rate of 15% took effect in Irish law on January 1, 2024.

  • 43% rewrittenRisks Related to our Financial Condition and Tax Matters

    Our 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

    Clarified heading to emphasize potential share price harm, funding unavailability, and shareholder dilution from future transactions.

  • 34% rewrittenRisks Related to Our Business and Our Industry

    We are subject to risks related to the manufacture of our products

    No substantive changes were identified in the manufacturing risk text.

  • 28% rewrittenRisks Related to Our Business and Our Industry

    Our revenues from sales of our products may decrease or grow at a slower than expected rate due to many factors

    Added physician and patient acceptance factors specifically concerning products scheduled by the DEA.

  • 27% rewrittenRisks Related to our Financial Condition and Tax Matters

    We may not be able to maintain profitability on a sustained basis

    Updated accumulated deficit figure to $0.7 billion as of December 31, 2025, and included 2025 net income.

  • 27% rewrittenRisks Related to our Financial Condition and Tax Matters

    If 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

    Added abbreviation Mural for Mural Oncology plc regarding the November 2023 spin-off tax separation.

  • 27% rewrittenRisks Related to Intellectual Property

    Uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we and our licensees have previously and may in the future face claims against IP rights covering our products and competition from generic drug manufacturers

    Was: Uncertainty 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

  • 27% rewrittenRisks Related to Our Business and Our Industry

    We receive substantial revenue from our key proprietary products and our success depends on our ability to successfully manufacture and commercialize such products

  • 20% rewrittenRisks Related to Our Business and Our Industry

    We rely 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

    Was: We 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

All 43 risk factors

Headings as the filing states them, in filing order.

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 products27% rewritten
  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 factors28% rewritten
  4. 04any other material adverse developments with respect to the commercialization of our products
  5. 05We may fail to realize some or all of the anticipated benefits and synergies of the Avadel Acquisition or to successfully integrate Avadel’s business, which could adversely affect our business and financial condition and the price of our ordinary sharesNew
  6. 06If 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
  7. 07We rely 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 affected20% rewritten
  8. 08Clinical trials for our products are expensive, may take several years to complete, and their outcomes are uncertain
  9. 09agencies, that may impact the strategies for, and design, timelines or feasibility of, our clinical development programs
  10. 10Our success depends, in part, on our ability to successfully obtain and maintain regulatory approval for our products59% rewritten
  11. 11Disruptions at the FDA, the SEC and other government agencies could negatively impact our business
  12. 12We may not be able to successfully expand our R&D pipeline or our commercial product portfolio, which could limit our growth potential
  13. 13We are subject to risks related to the manufacture of our products34% rewritten
  14. 14We rely on third parties to provide goods and services in connection with the manufacture and distribution of our products
  15. 15If 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 revenues55% rewritten
  16. 16Our success largely depends upon our ability to attract, recognize and retain key personnel

Risks Related to Intellectual Property

  1. 17Patent and other IP protection for our products is key to our business and our competitive position but is uncertain
  2. 18Uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we and our licensees have previously and may in the future face claims against IP rights covering our products and competition from generic drug manufacturers27% rewritten

Risks Related to Regulatory or Legal Matters

  1. 19The 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. 20We 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. 21Our business involves environmental, health and safety risks

Risks Related to our Financial Condition and Tax Matters

  1. 22We may not be able to maintain profitability on a sustained basis27% rewritten
  2. 23resolve favorably any commercial disputes that may arise in respect of collaborative arrangements from which we receive revenues
  3. 24We 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. 25If goodwill becomes impaired, we may have to take significant charges against earnings
  5. 26Our effective tax rate may increase
  6. 27Changes in tax rules and regulations, or interpretations thereof, may adversely affect our financial condition46% rewritten
  7. 28Our deferred tax assets may not be realized
  8. 29The disposition of the Athlone Facility may limit our ability to use our net operating losses and result in unanticipated tax liabilities
  9. 30The IRS may not agree with our conclusion that we should be treated as a foreign corporation for U.S. federal income tax purposes
  10. 31If 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 liabilities27% rewritten
  11. 32Our debt obligations could adversely affect our business and limit our ability to plan for or respond to changes in our businessNew
  12. 33placing us at a competitive disadvantage compared to our less leveraged competitorsNew
  13. 34Our 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 shareholders43% rewritten
  14. 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 any failure to comply could result in penalties and reputational damage
  3. 40Changes in global trade or other policies, including tariffs or other restrictions imposed by the U.S. government or governments of other nations, could have an adverse effect on our business, results of operations, or financial conditionNew
  4. 41A future pandemic, epidemic or outbreak of an infectious disease, may materially and adversely affect our business, financial condition and results of operations
  5. 42If 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
  6. 43The increasing use of social media platforms and artificial intelligence tools present new risks and challenges

Other Alkermes 10-Ks

  • FY2024 10-K risk factors
    42 risks

    Alkermes relies heavily on commercial sales of proprietary neuroscience products like VIVITROL, ARISTADA, and LYBALVI. The company faces significant intellectual property, pricing, and manufacturing compliance risks.

    Filed Feb 12, 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.