Alkermes plc.
For the period ended Sep 30, 2025. Filed Oct 28, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Oct 28, 2025
ALKS$45.90+3.1%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-07-29.
0000950170-25-099409
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-10-28.
0001193125-25-252524
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 8 previous paragraphs and 15 current paragraphs.
6 unchanged; 2 reworded; 7 added; 0 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 1 previous and 1 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (7)
Current report
We may not be able to complete the proposed strategic acquisition of Avadel on the timelines currently contemplated or at all, which could adversely affect our business and financial condition and the price of our ordinary shares.
Current report
On October 22, 2025, we announced our entry into a definitive transaction agreement with Avadel pursuant to which we agreed to acquire the entire issued and to be issued ordinary share capital of Avadel for total potential cash consideration of up to $20.00 per Avadel Share, as described in this Form 10-Q. The completion of the Proposed Acquisition is subject to customary conditions, including, among other things, approval by Avadel’s shareholders, the sanction of the Scheme by the Irish High Court, and the receipt of required antitrust clearances in the United States, and may be terminated by either party under certain circumstances. Subject to the satisfaction or waiver of all applicable closing conditions, we currently expect the Proposed Acquisition to be completed in the first quarter of 2026; however, we may not be able to satisfy or waive the conditions to the closing of the Proposed Acquisition on the expected timelines or at all, or the agreement may be terminated under certain circumstances.
Current report
The Proposed Acquisition may be difficult to complete for a number of reasons, including that we and Avadel may not be able to satisfy the conditions to closing. For example, we and/or Avadel, as applicable, may face difficulty and/or delays in obtaining the requisite shareholder approval, Irish High Court sanction or regulatory clearances in respect of the Proposed Acquisition on the anticipated timelines or at all. In addition, there may be unanticipated significant changes in transaction costs related to the Proposed Acquisition and/or unknown or inestimable liabilities and potential litigation that may arise in connection with the Proposed Acquisition. Further, competing offers may be made for Avadel, or the board of directors of Avadel may, in certain circumstances, change its recommendation regarding consummation of the Proposed Acquisition. The announcement of the Proposed Acquisition and the time and effort taken to consummate the Proposed Acquisition could result in disruption to the Company’s or Avadel’s respective businesses, including potential disruptions to certain third-party business and operational relationships that are important to Avadel’s business, or impacts on the ability of each of Alkermes and Avadel to attract and retain highly qualified management and key personnel. In addition, the Transaction Agreement in respect of the Proposed Acquisition contains customary termination rights that may be invoked in advance of completion of the Proposed Acquisition under certain circumstances. For any of these reasons, we may face difficulty in completing the Proposed Acquisition, and no assurance can be given as to whether we will complete the Proposed Acquisition on our anticipated timeline or at all, which could adversely affect our business strategy and financial planning and condition. Further, any potential negative reactions from the financial markets, whether as a result of the announcement of the Proposed Acquisition or any delay or failure in completing the Proposed Acquisition, could have a negative impact on our business and financial condition or the market price for our ordinary shares.
Current report
Even if the proposed acquisition of Avadel is completed, we may fail to realize some or all of the anticipated benefits and synergies of the proposed acquisition or successfully integrate Avadel’s business, which could adversely affect our business and financial condition and the price of our ordinary shares.
Current report
Even if the Proposed Acquisition is completed, the businesses of Alkermes and Avadel may not be effectively integrated and the anticipated operational, financial, strategic and other benefits and synergies of the Proposed Acquisition may not be achieved. These anticipated benefits and synergies are based on a number of assumptions and uncertainties, which may prove to be incorrect or incomplete. We may not be able to successfully integrate our and Avadel’s operations, and difficulties may arise relating to employee morale, such as the potential loss of key employees that may be difficult to replace, diversion of management’s attention from operation of the business, the failure to harmonize both companies’ corporate cultures, the disruption of each company’s ongoing businesses or inconsistencies in standards, controls, procedures and policies that adversely affect our or Avadel’s ability to maintain third-party relationships. In addition, there may be general economic, political, market and business conditions, or future exchange and interest rates, changes in tax laws, regulations, rates and policies, that could have a negative impact on Alkermes, Avadel or the combined organization following consummation of the Proposed Acquisition. In addition, Avadel’s product could be shown to be ineffective or unsafe, may prove difficult to manufacture be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse and we may not be able to continue to successfully commercialize Avadel’s product or support revenue growth from such product. Any of the foregoing may result in our not achieving the operational, financial, strategic and other benefits and synergies we anticipate realizing as a result of the Proposed Acquisition within the expected timeframe or at all, or they may take longer to realize or cost more than expected, and in each case, our business, results of operations and financial condition and/or the market price for our ordinary shares could be adversely affected.
Current report
Our debt obligations could adversely affect our business and limit our ability to plan for or respond to changes in our business.
Current report
In connection with the Proposed Acquisition, Alkermes plc and Alkermes, Inc. entered into the Bridge Credit Agreement, which provides for the Bridge Credit Facility in an aggregate principal amount of up to approximately $1.2 billion that is available to finance the payment of Cash Consideration and fees and expenses related to the Proposed Acquisition. While we expect to obtain permanent financing in lieu of utilizing funds available under the Bridge Credit Agreement, we cannot guarantee that we will obtain such permanent financing on terms that are acceptable to us or at all. If we are not successful in obtaining permanent financing due to market conditions or other factors and are required to utilize funds under the Bridge Credit Agreement, we will incur significantly higher borrowing costs than currently contemplated. In addition, the Bridge Credit Agreement requires the maintenance of certain leverage and coverage ratios, in each case, with the levels set forth in the Bridge Credit Agreement, as of the last day of any fiscal quarter ending after the date on which the loans under the Bridge Credit Facility are funded. In addition, the Bridge Credit Agreement contains customary affirmative and negative covenants, including limitations on indebtedness, liens, mergers, consolidations, sales of assets, investments, transactions with affiliates, restricted payments and sales and leasebacks. The Bridge Credit Agreement is guaranteed by certain of the Company’s subsidiaries and secured by a lien on substantially all of the assets of Alkermes plc, Alkermes, Inc. and their subsidiary guarantors. Our failure to comply with these restrictions or to make payments could lead to an event of default that could result in an acceleration of the indebtedness. Our future operating results may not be sufficient to ensure our ability to make our debt payments or to remedy any such default.
Reworded paragraphs (2)
Previous wording
The below risk factor should be read in conjunction with the risk factors disclosed in “Part I, Item 1A—Risk Factors” of our Annual Report.
Current wording
The below risk factors should be read in conjunction with the risk factors disclosed in “Part I, Item 1A—Risk Factors” of our Annual Report.
Previous wording
As a global biopharmaceutical company, changes in and uncertainties from global trade or other policies, including tariffs or other restrictions imposed by the U.S. government or governments of other nations, may have an adverse effect on us. For example, in April 2025, the U.S. government announced the imposition of a baseline 10% tariff on imports from virtually all countries and additional customized tariffs on certain imports (including country-specific and product-specific tariffs), following its imposition of a 25% tariff on certain imports from Mexico and Canada earlier in 2025. In response, certain countries have imposed, or announced intentions to impose, tariffs on U.S. imports. Although some of these tariffs are temporarily paused, their impact has already been seen, and we expect will continue to be seen, in global markets. Our proprietary products are manufactured at our manufacturing facility in the U.S. and are sold exclusively in the U.S.; however, certain materials in our supply chain are sourced internationally and certain of the third-party products from which we derive revenue are manufactured outside the U.S. Our related costs, revenues and/or profits may be impacted to varying degrees by recent or future changes in global trade or other policies. In addition, the recent changes, tensions and uncertainties related to global trade policies have caused, and may continue to cause, significant volatility in global markets, including the market for our ordinary shares. The price of our ordinary shares has fluctuated significantly, and may continue to fluctuate, as a result of these and similar developments. The U.S. government has also indicated that it may impose a supplemental tariff on all pharmaceutical imports or take additional actions in respect of pharmaceutical companies incorporated outside of the U.S., which has caused, and may continue to cause, uncertainty as to the extent of the impacts of changes in global trade on the pharmaceutical industry as a whole and on our business. Additional changes to the policies of the U.S. or other nations that affect the geopolitical landscape or global trade, economic or market conditions, and other direct or indirect impacts of such policies, are uncertain and unpredictable, and could, in the future, have a material adverse effect on our business, results of operations, or financial condition and the market price of our ordinary shares.
Current wording
As a global biopharmaceutical company, changes in and uncertainties from global trade or other policies, including tariffs or other restrictions imposed by the U.S. government or governments of other nations, may have an adverse effect on us. For example, since April 2025, the U.S. government and certain other countries have imposed tariffs or negotiated trade agreements for tariffs on certain imports. Although some of these tariffs are temporarily paused, their impact has already been seen, and we expect will continue to be seen, in global markets. Our proprietary products are manufactured at our manufacturing facility in the U.S. and are sold exclusively in the U.S.; however, certain materials in our supply chain are sourced internationally and certain third-party products from which we derive revenue are manufactured outside the U.S. Our related costs, revenues and/or profits may be impacted to varying degrees by recent or future changes in global trade or other policies. In addition, the recent changes, tensions and uncertainties related to global trade policies have caused, and may continue to cause, significant volatility in global markets, including the market for our ordinary shares. The price of our ordinary shares has fluctuated significantly, and may continue to fluctuate, as a result of these and similar developments. The U.S. government has also indicated that it may impose a supplemental tariff on all pharmaceutical imports or take additional actions in respect of pharmaceutical companies incorporated outside of the U.S., which has caused, and may continue to cause, uncertainty as to the extent of the impacts of changes in global trade on the pharmaceutical industry as a whole and on our business. Additional changes to the policies of the U.S. or other nations that affect the geopolitical landscape or global trade, economic or market conditions, and other direct or indirect impacts of such policies, are uncertain and unpredictable, and could, in the future, have a material adverse effect on our business, results of operations, or financial condition and the market price of our ordinary shares.