21 unchanged sentences
Trading Plans
−Removed: During the quarter ended December 31, 2023, the following officers (as defined in Rule 16a-1(f) under the Exchange Act) of the Company adopted contracts, instructions or written plans for the purchase or sale of the Company’s securities that were intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act (each, a “Rule 10b5-1 plan”):
−Removed: On December 14, 2023 , Craig Hopkinson, M.D ., our Executive Vice President , Research and Development and Chief Medical Officer, adopted a Rule 10b5-1 plan providing for the sale of up to 820,467 ordinary shares of the Company (including shares that may be obtained from the exercise of vested stock options or vesting of restricted stock unit awards);
−Removed: this plan is scheduled to expire on July 31, 2025 .
−Removed: On December 14, 2023 , Christian Todd Nichols , our Senior Vice President Chief Commercial Officer , adopted a Rule 10b5-1 plan providing for the sale of up to 10,417 ordinary shares of the Company;
−Removed: this plan is scheduled to expire on August 2, 2024 .
−Removed: During the quarter ended December 31, 2023, no other officers or directors of the Company adopted , modified or terminated a Rule 10b5-1 plan or a trading plan not intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.
+Added: During the three months ended December 31, 2024, no officer (as defined in Rule 16a-1(f) under the Exchange Act) or director of the Company adopted , modified or terminated a contract, instruction or written plan for the purchase or sale of securities of the Company that were intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act or a trading plan not intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
2 unchanged sentences
The information required by this item is incorporated herein by reference to our definitive proxy statement for our 2025 annual general meeting of shareholders.
+Added: We expect this information will be provided under sections of the proxy statement entitled “Proposal 1—Election of Directors,” “The Role of the Board and Its Committees,” “Executive Officers,” “Other Corporate Governance Matters” and “Board Nominations, Evaluations and Refreshment” and, if required, “Delinquent Section 16(a) Reports”.
Executi ve Compensation
The information required by this item (excluding, for clarity, the information required by Item 402(v) of Regulation S-K) is incorporated herein by reference to our definitive proxy statement for our 2025 annual general meeting of shareholders.
+Added: We expect this information will be provided under sections of the proxy statement entitled “The Role of the Board and Its Committees,” “Director Compensation,” “Executive Compensation—Compensation Discussion and Analysis,” “Executive Compensation Tables,” “Additional Compensation Information,” “Compensation Committee Report” and “Pay Ratio”.
Security Ownership of Certa in Beneficial Owners and Management and Related Stockholder Matters
The information required by this item is incorporated herein by reference to our definitive proxy statement for our 2025 annual general meeting of shareholders.
+Added: We expect this information will be provided under sections of the proxy statement entitled “Ownership of the Company’s Ordinary Shares” and “Equity Compensation Plan Information”.
Certain Relationships and Relate d Transactions, and Director Independence
The information required by this item is incorporated herein by reference to our definitive proxy statement for our 2025 annual general meeting of shareholders.
+Added: We expect this information will be provided under sections of the proxy statement entitled “Certain Relationships and Related Party Transactions” and “The Board of Directors”.
Principal Accou nting Fees and Services
The information required by this item is incorporated herein by reference to our definitive proxy statement for our 2025 annual general meeting of shareholders.
+Added: We expect this information will be provided under a section of the proxy statement entitled “Audit Fees”.
Exhibits and Fina ncial Statement Schedules
12 unchanged sentences
Description of Exhibit
−Removed: Purchase and Sale Agreement, dated March 7, 2015, by and among Alkermes Pharma Ireland Limited, Daravita Limited, Eagle Holdings USA, Inc., Recro Pharma, Inc., and Recro Pharma LLC (assigned by Recro to Baudax Bio, Inc.
−Removed: in November 2019).
Agreement and Plan of Merger, dated November 14, 2019 by and among Alkermes, Inc., Thinker Merger Sub, Inc., Alkermes plc, Rodin Therapeutics, Inc., and Shareholder Representative Services LLC, as Company Equityholder Representative.
5 unchanged sentences
Memorandum and Articles of Association of Alkermes plc.
+Added: Exhibit 3.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No.
Description of Securities.
24 unchanged sentences
February 15, 2019
−Removed: Incorporated by reference herein
−Removed: Description of Exhibit
Sixth Amendment to Lease between Alkermes, Inc.
2 unchanged sentences
October 29, 2020
+Added: Incorporated by reference herein
+Added: Description of Exhibit
License Agreement, dated as of February 13, 1996, between Medisorb Technologies International L.P.
62 unchanged sentences
and Alkermes Controlled Therapeutics Inc.
+Added: II (assigned to Alkermes, Inc.
+Added: in July 2006), effective as of July 1, 2018.
Exhibit 10.11 to the Alkermes plc Quarterly Report on Form 10-Q (File No.
2 unchanged sentences
Description of Exhibit
−Removed: II (assigned to Alkermes, Inc.
−Removed: in July 2006), effective as of July 1, 2018.
−Removed: Development and License Agreement, dated as of May 15, 2000, by and between Alkermes Controlled Therapeutics Inc.
−Removed: II and Amylin Pharmaceuticals, Inc., as amended on October 24, 2005 and July 17, 2006 (assigned, as amended, to Alkermes, Inc.
−Removed: in July 2006).
−Removed: Third Amendment to Development and License Agreement, dated March 20, 2018, by and between Amylin Pharmaceuticals, LLC and Alkermes Pharma Ireland Limited (as successor-in-interest to Alkermes Controlled Therapeutics Inc.
−Removed: II), amending that certain Development and License Agreement, by and between ACTII and Amylin, dated May 15, 2000, as amended on October 24, 2005 and July 17, 2006.
Agreement by and between JPI Pharmaceutica International, Janssen Pharmaceutica Inc.
24 unchanged sentences
April 26, 2023
−Removed: Amendment to First Lien Credit Agreement, dated September 25, 2012, among Alkermes, Inc., Alkermes plc, the guarantors party thereto, the lenders party thereto, Morgan Stanley Senior Funding, Inc.
−Removed: as Administrative Agent and Collateral Agent and the arrangers and agents party thereto.
−Removed: Exhibit 10.1 to the Alkermes plc Current Report on Form 8-K (File No.
−Removed: September 25, 2012
−Removed: Amendment No.
−Removed: 2, dated as of February 14, 2013, to Amended and Restated Credit Agreement, dated as of September 16, 2011, as amended and restated on September 25, 2012, among Alkermes, Inc., Alkermes plc, the guarantors party thereto, the lenders party thereto, Morgan Stanley Senior Funding, Inc.
−Removed: as Administrative Agent and Collateral Agent and the arrangers and agents party thereto.
−Removed: Exhibit 10.1 to the Alkermes plc Current Report on Form 8-K (File No.
−Removed: February 19, 2013
−Removed: Amendment No.
−Removed: 3 and Waiver to Amended and Restated Credit Agreement, dated as of May 22, 2013, among Alkermes, Inc., Alkermes plc, Alkermes Pharma Ireland Limited, Alkermes US Holdings, Inc., Morgan Stanley Senior Funding, Inc.
−Removed: as Administrative Agent and Collateral Agent and the lenders party thereto.
−Removed: Exhibit 10.52 to the Alkermes plc Annual Report on Form 10-K (File No.
−Removed: Amendment No.
−Removed: 4, dated as of October 12, 2016, to Amended and Restated Credit Agreement, dated as of September 16, 2011, as amended and restated on September 25, 2012, as further
−Removed: Exhibit 10.2 to the Alkermes plc Quarterly Report on Form 10-Q (File No.
−Removed: November 2, 2016
−Removed: Incorporated by reference herein
−Removed: Description of Exhibit
−Removed: amended by Amendment No.
−Removed: 2 on February 14, 2013 and as amended by Amendment No.
−Removed: 3 and Waiver to Amended and Restated Credit Agreement dated as of May 22, 2013, among Alkermes, Inc., Alkermes plc, the guarantors party thereto, the lenders party thereto and Morgan Stanley Senior Funding, Inc.
−Removed: as Administrative Agent and Collateral Agent.
−Removed: Amendment No.
−Removed: 5, dated as of March 26, 2018, to Amended and Restated Credit Agreement, dated as of September 16, 2011, as amended and restated on September 25, 2012, as further amended by Amendment No.
−Removed: 2 on February 14, 2013, as amended by Amendment No.
−Removed: 3 and Waiver to Amended and Restated Credit Agreement dated as of May 22, 2013, and as amended by Amendment No.
−Removed: 4, dated as of October 12, 2016, among Alkermes, Inc., Alkermes plc, the guarantors party thereto, the lenders party thereto and Morgan Stanley Senior Funding, Inc.
−Removed: as Administrative Agent and Collateral Agent.
−Removed: Exhibit 10.5 to the Alkermes plc Quarterly Report on Form 10-Q (File No.
−Removed: April 26, 2018
−Removed: Amendment No.
−Removed: 6, dated as of March 12, 2021, to Amended and Restated Credit Agreement, dated as of September 16, 2011, as amended and restated on September 25, 2012, as further amended by Amendment No.
−Removed: 2 on February 14, 2013, as amended by Amendment No.
−Removed: 3 and Waiver to Amended and Restated Credit Agreement dated as of May 22, 2013, as amended by Amendment No.
−Removed: 4, dated as of October 12, 2016, and as amended by Amendment No.
−Removed: 5, dated as of March 26, 2018, among Alkermes, Inc., Alkermes plc, the guarantors party thereto, the lenders party thereto and Morgan Stanley Senior Funding, Inc.
−Removed: as Administrative Agent and Collateral Agent.
−Removed: Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No.
−Removed: April 28, 2021
−Removed: Amendment No.
−Removed: 7, dated as of June 28, 2023, to Amended and Restated Credit Agreement, dated as of September 16, 2011, as amended and restated on September 25, 2012, as further amended by Amendment No.
−Removed: 2 on February 14, 2013, as amended by Amendment No.
−Removed: 3 and Waiver to Amended and Restated Credit Agreement dated as of May 22, 2013, as amended by Amendment No.
−Removed: 4, dated as of October 12, 2016, as amended by Amendment No.
−Removed: 5, dated as of March 26, 2018, and as amended by Amendment No.
−Removed: 6, dated as of March 12, 2021, among Alkermes, Inc., Alkermes plc, the guarantors party thereto, the lenders party thereto and Morgan Stanley Senior Funding, Inc.
−Removed: as Administrative Agent and Collateral Agent.
−Removed: Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No.
−Removed: July 26, 2023
−Removed: License and Collaboration Agreement, dated November 27, 2017, by and between Alkermes Pharma Ireland Limited and Biogen Swiss Manufacturing GmbH.
+Added: License and Collaboration Agreement, dated November 27, 2017, by and between Alkermes Pharma Ireland Limited and Biogen International GmbH (as successor to Biogen Swiss Manufacturing GmbH).
Exhibit 10.10 to the Alkermes plc Annual Report on Form 10-K (File No.
February 16, 2018
−Removed: First Amendment to License and Collaboration Agreement between Alkermes Pharma Ireland Limited and Biogen Swiss Manufacturing GmbH, effective as of October 3, 2018.
+Added: First Amendment to License and Collaboration Agreement between Alkermes Pharma Ireland Limited and Biogen International GmbH (as successor to Biogen Swiss Manufacturing GmbH), effective as of October 3, 2018.
Exhibit 10.12 to the Alkermes plc Quarterly Report on Form 10-Q (File No.
October 23, 2018
−Removed: Second Amendment to License and Collaboration Agreement between Alkermes Pharma Ireland Limited and Biogen Swiss Manufacturing GmbH, effective as of January 31, 2019.
+Added: Second Amendment to License and Collaboration Agreement between Alkermes Pharma Ireland Limited and Biogen International GmbH (as successor to Biogen Swiss Manufacturing GmbH), effective as of January 31, 2019.
Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No.
April 25, 2019
−Removed: Third Amendment to License and Collaboration Agreement between Alkermes Pharma Ireland Limited and Biogen Swiss Manufacturing GmbH, effective as of October 30, 2019.
+Added: Third Amendment to License and Collaboration Agreement between Alkermes Pharma Ireland Limited and Biogen International GmbH (as successor to Biogen Swiss Manufacturing GmbH), effective as of October 30, 2019.
Exhibit 10.10.3 to the Alkermes plc Annual Report on Form 10-K (File No.
February 13, 2020
−Removed: Fourth Amendment to License and Collaboration Agreement between Alkermes Pharma Ireland Limited and Biogen Swiss Manufacturing GmbH, effective as of August 25, 2022.
+Added: Fourth Amendment to License and Collaboration Agreement between Alkermes Pharma Ireland Limited and Biogen International GmbH (as successor to Biogen Swiss Manufacturing GmbH), effective as of August 25, 2022.
Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No.
November 2, 2022
+Added: Fifth Amendment to License and Collaboration Agreement between Alkermes Pharma Ireland Limited and Biogen International GmbH (as successor to Biogen Swiss Manufacturing GmbH), effective as of June 7, 2024.
+Added: Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No.
+Added: July 24, 2024
Lease, dated March 23, 2018, by and between Alkermes, Inc.
2 unchanged sentences
April 26, 2018
−Removed: Incorporated by reference herein
−Removed: Description of Exhibit
First Amendment to Lease, dated June 21, 2018, by and between Alkermes, Inc.
6 unchanged sentences
July 25, 2019
+Added: Incorporated by reference herein
+Added: Description of Exhibit
Confidential Settlement and License Agreement, dated August 29, 2023, by and among Alkermes, Inc., Alkermes Pharma Ireland Limited and Teva Pharmaceuticals USA, Inc.
4 unchanged sentences
November 15, 2023
−Removed: Employee Matters Agreement, dated November 13, 2023, by and between Alkermes plc and Mural Oncology plc.
−Removed: Exhibit 10.2 to the Alkermes plc Current Report on Form 8-K (File No.
−Removed: November 15, 2023
−Removed: Amendment to Employee Matters Agreement, dated December 14, 2023, by and between Alkermes plc and Mural Oncology plc.
−Removed: Transition Services Agreement, dated November 13, 2023, by and between Alkermes, Inc.
−Removed: and Mural Oncology, Inc.
−Removed: Exhibit 10.3 to the Alkermes plc Current Report on Form 8-K (File No.
−Removed: November 15, 2023
−Removed: Transition Services Agreement, dated November 13, 2023, by and between Mural Oncology, Inc.
−Removed: and Alkermes, Inc.
−Removed: Exhibit 10.4 to the Alkermes plc Current Report on Form 8-K (File No.
−Removed: November 15, 2023
Asset Purchase Agreement, dated December 13, 2023, by and between Alkermes Pharma Ireland Limited, Novo Nordisk Production Ireland Limited and Novo Nordisk A/S.
+Added: Exhibit 10.16 to the Alkermes plc Annual Report on Form 10-K (File No.
+Added: February 21, 2024
Employment Agreement, dated as of December 12, 2007, by and between Richard F.
15 unchanged sentences
Form of Employment Agreement, as amended by the Form of Amendment to Employment Agreement set forth in 10.12.1, entered into by and between Alkermes, Inc.
−Removed: and each of Blair C.
−Removed: Jackson and Michael J.
Exhibit 10.3 to the Alkermes, Inc.
5 unchanged sentences
October 7, 2008
−Removed: Form of Covenant Not to Compete, of various dates, by and between Alkermes, Inc.
−Removed: and Michael J.
−Removed: Exhibit 10.15(a) to the Alkermes, Inc.
−Removed: Annual Report on Form 10-K (File No.
Form of Employment Agreement entered into by and between Alkermes, Inc.
10 unchanged sentences
February 16, 2018
−Removed: Incorporated by reference herein
−Removed: Description of Exhibit
Offer Letter, dated March 29, 2019, by and between Alkermes, Inc.
16 unchanged sentences
Form of Restricted Stock Unit Award Certificate (Time Vesting Only – Irish) under the Alkermes plc Amended and Restated 2008 Stock Option and Incentive Plan, as amended.
−Removed: Exhibit 10.5 to the Alkermes plc Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 (File No.
+Added: Exhibit 10.5 to the Alkermes plc Quarterly Report on Form 10-Q for the quarter ended
April 28, 2016
+Added: Incorporated by reference herein
+Added: Description of Exhibit
+Added: March 31, 2016 (File No.
Form of Restricted Stock Unit Award Certificate (Time Vesting Only – U.S.) under the Alkermes plc Amended and Restated 2008 Stock Option and Incentive Plan, as amended.
21 unchanged sentences
October 23, 2018
−Removed: Incorporated by reference herein
−Removed: Description of Exhibit
Form of Restricted Stock Unit (Time-Vesting) Award Certificate under the Alkermes plc 2011 Stock Option and Incentive Plan, as amended.
18 unchanged sentences
October 23, 2018
+Added: Incorporated by reference herein
+Added: Description of Exhibit
Form of Restricted Stock Unit (Performance-Vesting) Award Certificate under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
26 unchanged sentences
Form of Restricted Stock Unit (Performance-Vesting) Award Certificate (rev.
−Removed: 2024) for Reporting Officers under the
−Removed: Incorporated by reference herein
−Removed: Description of Exhibit
−Removed: Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
+Added: 2024) for Reporting Officers under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
+Added: Exhibit 10.25M to the Alkermes plc Annual Report on Form 10-K (File No.
+Added: February 21, 2024
Form of Restricted Stock Unit (Performance-Vesting) Award Certificate (rev.
2024) under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
+Added: Exhibit 10.25N to the Alkermes plc Annual Report on Form 10-K (File No.
+Added: February 21, 2024
+Added: Form of Non-Employee Director Non-Qualified Stock Option Award Certificate (rev.
+Added: 2024) under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
+Added: Exhibit 10.2A to the Alkermes plc Quarterly Report on Form 10-Q (File No.
+Added: July 24, 2024
+Added: Form of Non-Employee Director Restricted Stock Unit Award (Time-Vesting) Award Certificate (rev.
+Added: 2024) under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
+Added: Exhibit 10.2A to the Alkermes plc Quarterly Report on Form 10-Q (File No.
+Added: July 24, 2024
+Added: Alkermes plc Insider Trading Policy.
List of subsidiaries.
2 unchanged sentences
Certification Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934.
+Added: Incorporated by reference herein
+Added: Description of Exhibit
Certification Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934.
2 unchanged sentences
Alkermes plc Incentive Compensation Recoupment Policy.
+Added: Exhibit 97 to the Alkermes plc Annual Report on Form 10-K (File No.
+Added: February 21, 2024
Inline XBRL Taxonomy Extension Schema with Embedded Linkbases Document.
11 unchanged sentences
Securities and Exchange Commission.
−Removed: Filed with this Annual Report solely for the purpose of transitioning this previously-filed exhibit, which is the subject of an expiring confidential treatment order, to the rules governing the filing of redacted exhibits under Regulation S-K Item 601(b) pursuant to the SEC’s CF Disclosure Guidance:
−Removed: Portions of this exhibit (indicated by “[**]”) have been omitted pursuant to Item 601(b) of Regulation S-K.
−Removed: Schedules and similar attachments to this exhibit have been omitted pursuant to Item 601(a)(5) of Regulation S-K.
−Removed: The Company undertakes to furnish copies of any omitted schedules and similar attachments upon request by the U.S.
−Removed: Securities and Exchange Commission.
Form 10-K Summary
6 unchanged sentences
Each person whose signature appears below in so signing also makes, constitutes and appoints Richard F.
−Removed: Pops and Iain M.
−Removed: Brown, and each of them, his true and lawful attorney-in-fact, with full power of substitution, for him in any and all capacities, to execute and cause to be filed with the Securities and Exchange Commission any and all amendments to this Annual Report, with exhibits thereto and other documents in connection therewith, and hereby ratifies and confirms all that said attorney-in-fact or his substitute or substitutes may do or cause to be done by virtue hereof.
+Added: Pops and Blair C.
+Added: Jackson, and each of them, his true and lawful attorney-in-fact, with full power of substitution, for him in any and all capacities, to execute and cause to be filed with the Securities and Exchange Commission any and all amendments to this Annual Report, with exhibits thereto and other documents in connection therewith, and hereby ratifies and confirms all that said attorney-in-fact or his substitute or substitutes may do or cause to be done by virtue hereof.
/s/ Richard F.
17 unchanged sentences
February 12, 2025
+Added: February 12, 2025
/s/ Frank Anders Wilson
32 unchanged sentences
Critical Audit Matters
−Removed: The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that (i) relate to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments.
−Removed: The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
−Removed: Tax-Free Determination of the Separation of the Oncology Business
−Removed: As described in Notes 1 and 3 to the consolidated financial statements, the Company completed the separation of its oncology business into a new, independent, publicly-traded company on November 15, 2023.
−Removed: The separation was effected by means of a distribution of shares to the Company’s shareholders.
−Removed: Management determined that the separation and related distribution qualified as tax-free for U.S.
−Removed: federal income tax purposes, which required significant judgment by management.
−Removed: In making such determinations, management applied U.S.
−Removed: federal tax law to relevant facts and circumstances and obtained:
−Removed: (i) a favorable private letter ruling from the IRS;
−Removed: (ii) a tax opinion;
−Removed: and (iii) other external tax advice related to the concluded tax treatment.
−Removed: If the separation and distribution were to fail to qualify for tax-free treatment for U.S.
−Removed: federal income tax purposes, the Company and/or its shareholders could be subject to significant liabilities, which could have material adverse impacts on the Company’s business, financial condition, results of operations and cash flows in future reporting periods.
−Removed: The principal considerations for our determination that performing procedures relating to the tax-free determination of the separation of the oncology business is a critical audit matter are (i) the significant judgment by management with regards to interpretation of the facts and the application of tax laws and regulations in order to conclude the divestiture would qualify as a tax-free transaction, (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating audit evidence in connection with management’s tax-free determination, and (iii) the audit effort involved the use of professionals with specialized skill and knowledge.
−Removed: Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements.
−Removed: These procedures included testing the effectiveness of controls relating to the key judgments in management’s evaluation of the tax treatment of the transaction.
−Removed: These procedures also included, among others (i) testing management’s process for determining the tax-free treatment of the transaction, (ii) evaluating the information used in management’s determination, such as tax rulings from relevant taxing authorities and supporting information, tax opinion, and relevant tax laws, and (iii) evaluating the reasonableness of management’s position that the transaction qualifies for tax-free status.
−Removed: Professionals with specialized skill and knowledge were used to assist in evaluating the transaction, the application of tax laws and regulations, the private letter ruling and tax opinion, and certain representations from management
+Added: The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments.
+Added: The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Rebate Accruals – Medicaid Drug Rebate Program
−Removed: As described in Notes 2 and 11 to the consolidated financial statements, the Company’s revenue from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with the Company’s customers, health care providers or payers.
+Added: As described in Notes 2 and 11 to the consolidated financial statements, the Company’s revenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with the Company’s customers, health care providers or payers.
The Company records accruals for rebates to U.S.
4 unchanged sentences
The Company estimates expected unit sales to individuals covered by Medicaid and rebates per unit under the Medicaid program and adjusts its rebate accrual based on actual unit sales and rebates per unit and changes in trends in Medicaid utilization.
−Removed: The principal considerations for our determination that performing procedures relating to rebate accruals for the Medicaid Drug Rebate Program is a critical audit matter are (i) the significant judgment by management due to significant
−Removed: measurement uncertainty involved in developing the reserves, as the reserves are based on assumptions developed using historical experience, current contractual requirements, specific known market events and payment patterns and (ii) a high degree of auditor judgment, subjectivity and effort in applying procedures and evaluating evidence related to these assumptions.
+Added: The principal considerations for our determination that performing procedures relating to rebate accruals for the Medicaid Drug Rebate Program is a critical audit matter are (i) the significant judgment by management due to significant measurement uncertainty involved in developing the reserves, as the reserves are based on assumptions developed using historical experience, current contractual requirements, specific known market events and payment patterns and (ii) a high degree of auditor judgment, subjectivity and effort in applying procedures and evaluating evidence related to these assumptions.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements.
15 unchanged sentences
Cash and cash equivalents
−Removed: Receivables, net
Investments—short-term
−Removed: Contract assets
+Added: Receivables, net
Prepaid expenses and other current assets
−Removed: Assets related to discontinued operations
+Added: Contract assets
Assets held for sale
3 unchanged sentences
RIGHT-OF-USE ASSETS
−Removed: ASSETS RELATED TO DISCONTINUED OPERATIONS—LONG-TERM
−Removed: ASSETS HELD FOR SALE—LONG-TERM
−Removed: INTANGIBLE ASSETS, NET
+Added: INTANGIBLE ASSETS, NET AND GOODWILL
DEFERRED TAX ASSETS
10 unchanged sentences
OPERATING LEASE LIABILITIES—LONG-TERM
−Removed: LIABILITIES RELATED TO DISCONTINUED OPERATIONS—LONG-TERM
OTHER LONG-TERM LIABILITIES
4 unchanged sentences
50,000,000 shares authorized;
−Removed: zero issued and outstanding at December 31, 2023 and 2022, respectively
+Added: and zero issued and outstanding at December 31, 2024 and 2023
Ordinary shares, par value, $ 0.01 per share;
1 unchanged sentence
176,670,785 and 172,569,051 shares issued;
−Removed: 166,979,833 and 164,377,009 shares outstanding at December 31, 2023 and 2022, respectively
+Added: and 162,176,994 and 166,979,833 shares outstanding at December 31, 2024 and 2023, respectively
Treasury shares, at cost ( 14,493,791 and 5,589,218 shares at December 31, 2024 and 2023, respectively)
20 unchanged sentences
Total expenses
−Removed: OPERATING INCOME (LOSS)
+Added: OPERATING INCOME FROM CONTINUING OPERATIONS
OTHER INCOME (EXPENSE), NET:
2 unchanged sentences
Change in the fair value of contingent consideration
−Removed: Other (expense) income, net
+Added: Other income (expense), net
Total other income (expense), net
INCOME (LOSS) BEFORE INCOME TAXES
−Removed: INCOME TAX (BENEFIT) PROVISION
+Added: INCOME TAX PROVISION (BENEFIT)
NET INCOME (LOSS) FROM CONTINUING OPERATIONS
−Removed: DISCONTINUED OPERATIONS, NET OF TAX
+Added: LOSS FROM DISCONTINUED OPERATIONS, NET OF TAX
NET INCOME (LOSS)
EARNINGS (LOSS) PER ORDINARY SHARE:
−Removed: Earnings (loss) per share from continuing operations - basic
−Removed: Earnings (loss) per share from discontinued operations - basic
−Removed: Earnings (loss) per share - basic
−Removed: Earnings (loss) per share from continuing operations - diluted
−Removed: Earnings (loss) per share from discontinued operations - diluted
−Removed: Earnings (loss) per share - diluted
+Added: Earnings (loss) per ordinary share from continuing operations - basic
+Added: Loss per ordinary share from discontinued operations - basic
+Added: Earnings (loss) per ordinary share - basic
+Added: Earnings (loss) per ordinary share from continuing operations - diluted
+Added: Loss per ordinary share from discontinued operations - diluted
+Added: Earnings (loss) per ordinary share - diluted
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING:
13 unchanged sentences
Issuance of ordinary shares under employee stock plans
−Removed: Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards
+Added: Receipt of Alkermes' ordinary shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards
Share-based compensation
2 unchanged sentences
Issuance of ordinary shares under employee stock plans
−Removed: Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards
+Added: Receipt of Alkermes' ordinary shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards
Share-based compensation
−Removed: Unrealized loss on marketable securities, net of tax benefit of $ 973
+Added: Unrealized gain on marketable securities, net of tax provision of $ 1,195
+Added: Distribution of Mural Oncology plc
BALANCE —December 31, 2023
Issuance of ordinary shares under employee stock plans
−Removed: Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards
+Added: Receipt of Alkermes' ordinary shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards
+Added: Repurchase of Alkermes' ordinary shares
Share-based compensation
Unrealized gain on marketable securities, net of tax provision of $ 292
−Removed: Distribution of Mural Oncology plc
BALANCE —December 31, 2024
28 unchanged sentences
Return of Fountain Healthcare Partners II, L.P.
−Removed: Payment made for licensed Intellectual Property ("IP")
+Added: Proceeds from the sale of the Athlone Facility
Purchases of investments
Sales and maturities of investments
−Removed: Cash flows provided by (used in) investing activities
+Added: Cash flows (used in) provided by investing activities
CASH FLOWS FROM FINANCING ACTIVITIES:
2 unchanged sentences
Employee taxes paid related to net share settlement of equity awards
−Removed: Proceeds from the issuance of long-term debt
−Removed: Payment made for debt extinguishment
+Added: Payment for the repurchase of ordinary shares
+Added: Prepayment of long-term debt
Principal payments of long-term debt
−Removed: Cash flows (used in) provided by financing activities
−Removed: NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
+Added: Cash flows used in financing activities
+Added: NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
CASH AND CASH EQUIVALENTS—Beginning of period
9 unchanged sentences
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
−Removed: Alkermes plc (the “Company”) is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience.
−Removed: The Company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder and a pipeline of clinical and preclinical candidates in development for neurological disorders.
−Removed: Headquartered in Dublin, Ireland, the Company has a research and development center in Waltham, Massachusetts;
−Removed: a research and manufacturing facility in Athlone, Ireland;
−Removed: and a manufacturing facility in Wilmington, Ohio.
−Removed: On November 15, 2023, the Company completed the separation of its oncology business into Mural Oncology plc (“Mural”), a new, independent, publicly-traded company (the “Separation”).
+Added: Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience.
+Added: Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence and opioid dependence, schizophrenia and bipolar I disorder and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia.
+Added: Headquartered in Ireland, Alkermes also has a corporate office and research and development (“R&D”) center in Massachusetts and a manufacturing facility in Ohio.
+Added: In May 2024, the Company completed the sale of its development and manufacturing facility in Athlone, Ireland (the “Athlone Facility”) and related business to Novo Nordisk (“Novo”) pursuant to an asset purchase agreement entered into in December 2023.
+Added: The Company and Novo also entered into subcontracting arrangements to continue certain development and manufacturing activities performed at the Athlone Facility for a period of time after the closing of the transaction, which activities may continue through the end of 2025.
+Added: In connection with the sale of the Athlone Facility, the Company received $ 97.9 million from Novo, which included a payment of approximately $ 91.0 million for the facility and certain related assets, and recorded a gain of approximately $ 1.5 million within “ Other income (expense), net ” in the accompanying consolidated statements of operations and comprehensive income (loss) for the year ended December 31, 2024.
+Added: As of December 31, 2023, the Company classified the assets described under the asset purchase agreement for the sale as “Assets held for sale” in the accompanying consolidated balance sheet.
+Added: In November 2023, the Company completed the separation of its former oncology business into Mural Oncology plc (“Mural”), a new, independent, publicly-traded company (the “Separation”).
The Separation was effected by means of a distribution of all of the outstanding ordinary shares of Mural to the Company’s shareholders (the “Distribution”), in which each of the Company’s shareholders received one ordinary share, nominal value $ 0.01 per share, of Mural for every ten ordinary shares, par value $ 0.01 per share, of the Company (the “Distribution Ratio”) held by such shareholder as of the close of business on November 6, 2023, the record date for the Distribution (the “Record Date”).
1 unchanged sentence
For additional information related to the Separation, see Note 3, Discontinued Operations in these “Notes to Consolidated Financial Statements” in this Annual Report.
−Removed: On December 14, 2023 the Company announced that it entered into a definitive agreement to sell its development and manufacturing facility located in Athlone, Ireland (the “Athlone Facility”) to Novo Nordisk (“Novo”) and plans to enter into subcontracting arrangements to continue certain development and manufacturing activities currently performed at the Athlone Facility for a period of time after the closing of the transaction, which arrangements may continue through the end of 2025.
−Removed: Such transaction is expected to close in mid-2024, subject to certain closing conditions.
−Removed: At December 31, 2023, the Company had classified the assets described under the related asset purchase agreement as “Assets held for sale” within the accompanying consolidated balance sheet.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
4 unchanged sentences
Reclassification
−Removed: The Company has presented its former oncology business as discontinued operations in its consolidated financial statements for all periods presented.
+Added: The Company has presented its former oncology business as discontinued operations in its consolidated financial statements as of December 31, 2023 and for the years ended December 31, 2023 and 2022.
See Note 3, Discontinued Operations in these “Notes to Consolidated Financial Statements” in this Annual Report for additional information.
−Removed: Additionally, as a result of the planned sale of the Athlone Facility, the Company has classified the assets described under the related asset purchase agreement as held for sale.
−Removed: The Company’s historical financial statements and footnotes have been recast accordingly.
Discontinued Operations
−Removed: The Company determined that the separation of its oncology business in November 2023 met the criteria for classification of the oncology business as discontinued operations in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 205, Discontinued Operations .
−Removed: Accordingly, the accompanying consolidated financial statements have been updated to present the assets and liabilities associated with the oncology business as discontinued operations as of December 31, 2022 on the consolidated balance sheets, and the results of the oncology business as discontinued operations through the Separation Date for the years ended December 31, 2023, 2022 and 2021 in the consolidated statements of operations and comprehensive income (loss).
+Added: The Company determined that the Separation met the criteria for classification of the former oncology business as discontinued operations in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 205, Discontinued Operations .
+Added: Accordingly, the accompanying consolidated financial statements have been updated to present the results of the oncology business as discontinued operations through the Separation Date for the years ended December 31, 2023 and 2022 in the consolidated statements of operations and comprehensive income (loss).
Assets Held for Sale
−Removed: In connection with the planned sale of the Athlone Facility, the Company reviewed FASB ASC 805, Business Combinations and, based on the definitions therein, has determined that the Athlone Facility constitutes a business.
−Removed: Accordingly, the assets associated with the planned sale of the Athlone Facility have been classified as “Assets held for sale” within the accompanying consolidated balance sheets as of December 31, 2023 and 2022.
+Added: In connection with the sale of the Athlone Facility, the Company reviewed FASB ASC 805, Business Combinations (“Topic 805”) and, based on the definitions therein, determined that the Athlone Facility constituted a business.
+Added: Accordingly, the assets associated with the sale of the Athlone Facility were classified as “Assets held for sale” in the accompanying consolidated balance sheet as of December 31, 2023.
ALKERMES PLC AND SUBSIDIARIES
2 unchanged sentences
The preparation of the Company’s consolidated financial statements in accordance with accounting principles generally accepted in the United States (“GAAP”) requires that Company management make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.
−Removed: On an on-going basis, the Company evaluates its estimates, judgments and methodologies, including but not limited to, those related to revenue from contracts with its customers and related allowances, impairment and amortization of intangibles and long-lived assets, share-based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of investments and litigation.
+Added: On an on-going basis, the Company evaluates its estimates, judgments and methodologies, including but not limited to, those related to revenue from contracts with its customers and related allowances, impairment of intangibles and long-lived assets, share-based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of investments and litigation.
The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities.
1 unchanged sentence
Cash and Cash Equivalents
−Removed: The Company values its cash and cash equivalents at cost plus accrued interest, which the Company believes approximates their market value.
−Removed: The Company considers as cash equivalents only those investments that are highly liquid, readily convertible into cash and so near their maturity (generally three months from the date of purchase) that they present insignificant risk of change in value because of interest rate changes.
−Removed: The Company has investments in various types of securities, consisting primarily of United States (“U.S.”) government and agency obligations, corporate debt securities and debt securities issued by non-U.S.
−Removed: agencies and backed by non-U.S.
+Added: The Company values its cash and cash equivalents at cost plus accrued interest, which the Company believes approximates its market value.
+Added: The Company considers as cash equivalents only those investments that are highly liquid, readily convertible into cash and so near their maturity (three months from the date of purchase) that they present insignificant risk of change in value because of interest rate changes.
+Added: The Company has investments in various types of securities, consisting primarily of United States (“U.S.”).
+Added: government and agency obligations and corporate debt securities.
The Company generally holds its interest-bearing investments with major financial institutions and in accordance with documented investment policies.
21 unchanged sentences
Assets utilizing Level 2 inputs at December 31, 2024 included U.S.
−Removed: government agency debt securities, debt securities issued by non-U.S.
−Removed: agencies and backed by non-U.S.
−Removed: governments and investments in corporate debt securities that are trading in the credit markets.
+Added: government agency debt securities and investments in corporate debt securities that are trading in the credit markets.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: The carrying amounts reflected in the consolidated balance sheets for cash and cash equivalents, accounts receivable, other current assets, accounts payable and accrued expenses approximate fair value due to their short-term nature.
+Added: The carrying amounts reflected in the consolidated balance sheets for cash and cash equivalents, accounts receivable, contract assets, other current assets, accounts payable and accrued expenses and accrued sales discounts, allowances and reserves approximate fair value due to their short-term nature.
Inventory is stated at the lower of cost and net realizable value.
+Added: The Company utilizes a standard cost basis, which approximates cost determined using the first-in first-out method.
Cost is determined using the first-in, first-out method.
4 unchanged sentences
and overhead.
−Removed: Overhead is based on the normal capacity of the Company’s production facilities and does not include costs from abnormally low production or idle capacity, which are expensed directly to the consolidated statement of operations and comprehensive income (loss).
+Added: Overhead is based on the normal capacity of the Company’s production facility and does not include costs from abnormally low production or idle capacity, which are expensed directly to the consolidated statement of operations and comprehensive income (loss).
The Company capitalizes inventory costs associated with its products prior to regulatory approval when, based on management’s judgment, future commercialization of the product is considered probable and future economic benefit from such product is expected to be realized.
7 unchanged sentences
Buildings and improvements
−Removed: 15 - 40 years
Furniture, fixtures and equipment
33 unchanged sentences
Revenue from Contracts with Customers
−Removed: The Company recognizes revenue in accordance with FASB ASC 606, Revenue from Contracts with Customers (“Topic 606”).
−Removed: When entering into arrangements with customers, the Company identifies whether its performance obligations under the arrangement represent a distinct good or service or a series of distinct goods or services.
−Removed: If a contract contains more than one performance obligation, the Company allocates the total transaction price to each performance obligation in an amount based on the estimated relative standalone selling prices of the promised goods or services underlying each performance obligation.
−Removed: The fair value of performance obligations under the arrangement may be derived using an estimate of selling price if the Company does not sell the goods or services separately.
−Removed: The Company recognizes revenue when or as it satisfies a performance obligation by transferring an asset or providing a service to a customer.
−Removed: Management judgment is required in determining the consideration to be earned under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement.
−Removed: Steering committee services that are not inconsequential or perfunctory and that are determined to be performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete its aggregate performance obligations.
+Added: The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which it expects to receive in exchange for those goods or services.
+Added: The Company recognizes revenue following the five-step model prescribed in accordance with FASB ASC 606, Revenue from Contracts with Customers (“Topic 606”):
+Added: (i) identify contract(s) with a customer;
+Added: (ii) identify the performance obligations in the contract;
+Added: (iii) determine the transaction price;
+Added: (iv) allocate the transaction price to the performance obligations in the contract;
+Added: and (v) recognize revenue when (or as) the Company satisfies the performance obligations.
Product Sales, Net
The Company’s product sales, net consist of sales in the U.S.
−Removed: of VIVITROL ® , ARISTADA ® and ARISTADA INITIO ® and LYBALVI ® , primarily to wholesalers, specialty distributors and pharmacies.
+Added: of VIVITROL ® , ARISTADA ® , ARISTADA INITIO ® and LYBALVI ® , primarily to wholesalers, specialty distributors and pharmacies.
Product sales, net are recognized when the customer obtains control of the product, which is when the product has been received by the customer.
10 unchanged sentences
The Company estimates expected unit sales to individuals covered by Medicaid and rebates per unit under the Medicaid program and adjusts its rebate accrual based on actual unit sales and rebates per unit and changes in trends in Medicaid utilization.
−Removed: To date, actual Medicaid rebates have not differed materially from the Company’s estimates;
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
+Added: In 2024, actual Medicaid utilization rates related to VIVITROL were lower than original estimates, due, in part, to $ 8.7 million in actual credits received from certain states in the fourth quarter of 2024 related to duplicate Medicaid billings.
+Added: Medicaid rebates for the Company’s other products have not differed materially from the Company’s estimates;
• Chargebacks —discounts that occur when contracted indirect customers purchase directly from wholesalers and specialty distributors.
4 unchanged sentences
To date, actual chargebacks have not differed materially from the Company’s estimates;
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
• Product Discounts —cash consideration, including sales incentives, given by the Company under agreements with a number of wholesaler, distributor, pharmacy, and treatment provider customers that provide them with a discount on the purchase price of products.
9 unchanged sentences
To date, actual Medicare Part D rebates have not differed materially from the Company’s estimates.
+Added: A rollfor ward of the Company’s provisions for sales and allowances is as follows:
+Added: December 31, 2024
+Added: (In thousands)
+Added: Contractual Adjustments (1)
+Added: Discounts (2)
+Added: Product Returns
+Added: Beginning balance — December 31, 2023
+Added: Current provisions relating to sales in current year
+Added: Adjustments relating to prior years
+Added: Payments/credits relating to sales in current year
+Added: Payments/credits relating to sales in prior years
+Added: Ending balance — December 31, 2024
+Added: December 31, 2023
+Added: (In thousands)
+Added: Contractual Adjustments (1)
+Added: Discounts (2)
+Added: Product Returns
+Added: Beginning balance — December 31, 2022
+Added: Current provisions relating to sales in current year
+Added: Adjustments relating to prior years
+Added: Payments/credits relating to sales in current year
+Added: Payments/credits relating to sales in prior years
+Added: Ending balance — December 31, 2023
+Added: December 31, 2022
+Added: (In thousands)
+Added: Contractual Adjustments (1)
+Added: Discounts (2)
+Added: Product Returns
+Added: Beginning balance — December 31, 2021
+Added: Current provisions relating to sales in current year
+Added: Adjustments relating to prior years
+Added: Payments/credits relating to sales in current year
+Added: Payments/credits relating to sales in prior years
+Added: Ending balance — December 31, 2022
+Added: (1) “Contractual Adjustments” include “Medicaid Rebates” and “Medicare Part D” accruals
+Added: (2) “Discounts” in clude “Chargebacks” and “Product Discounts”
+Added: Total revenue-related reserves as of December 31, 2024 and 2023, included in our consolidated balance sheets, are summarized as follows:
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
+Added: Year Ended December 31,
+Added: (In thousands)
+Added: Reduction of accounts receivable
+Added: Components of accrued sales discounts, allowances and reserves
+Added: Components of other long-term liabilities
+Added: Total revenue-related reserves
Collaborative Arrangements
1 unchanged sentence
(“Janssen, Inc.”), Janssen Pharmaceutica International, a division of Cilag International AG (“Janssen International”), and Janssen Pharmaceutica N.V.
−Removed: (together with Janssen, Inc., Janssen International and their affiliates, “Janssen”) related to INVEGA SUSTENNA ® /XEPLION ® , INVEGA TRINZA ® /TREVICTA ® , INVEGA HAFYERA ® /BYANNLI ® (the “long-acting INVEGA products”) and RISPERDAL CONSTA ® , and Biogen Swiss Manufacturing GmbH (together with its affiliates, “Biogen”) related to VUMERITY ® .
−Removed: Substantially all of the products developed under these arrangements are currently being marketed as approved products for which the Company receives payments for manufacturing services and/or royalties on net product sales.
+Added: (together with Janssen, Inc., Janssen International and their affiliates, “Janssen”) related to INVEGA SUSTENNA ® /XEPLION ® , INVEGA TRINZA ® /TREVICTA ® , INVEGA HAFYERA ® /BYANNLI ® (collectively, the “long-acting INVEGA products”) and RISPERDAL CONSTA ® , and Biogen International GmbH (together with its affiliates, “Biogen”) related to VUMERITY ® .
+Added: Substantially all of the products developed under these arrangements are currently being marketed as approved products for which the Company received or receives payments for manufacturing services and/or royalties on net product sales.
Manufacturing Revenue
13 unchanged sentences
The differences between the Company’s actual and estimated royalty revenues have not been material to date.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: License Revenue
−Removed: The Company recognizes revenue from the grant of distinct, right-to-use licenses of IP when control of the license is transferred to the licensee, which is the point in time that the licensee is able to direct the use of, and obtain substantially all of the benefits from the license.
Receivables, net
4 unchanged sentences
The allowance is based upon an assessment of customer creditworthiness, historical payment experience, the age of outstanding receivables and collateral to the extent applicable.
−Removed: The Company’s allowance for doubtful accounts was approximately $ 0.2 million at each of December 31, 2023 and 2022.
+Added: The Company’s allowance for doubtful accounts was approximately $ 0.3 million and $ 0.2 million at December 31, 2024 and 2023, respectively.
Contract Assets
1 unchanged sentence
The amounts included in the contract assets table below are classified as “Current assets” in the accompanying consolidated balance sheets, as they relate to manufacturing processes that are completed in ten days to eight weeks .
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Contract assets consisted of the following:
8 unchanged sentences
Contract liabilities consist of contractual obligations related to deferred revenue.
−Removed: At December 31, 2023 and 2022, $ 2.7 million and $ 6.8 million of the contract liabilities, respectively, were classified as “Contract liabilities–short-term” in the accompanying consolidated balance sheets and $ 2.1 million and $ 3.9 million of the contract liabilities, respectively, were classified as “Other long-term liabilities” in the accompanying consolidated balance sheets.
+Added: At December 31, 2024 and 2023, $ 1.2 million and $ 2.7 million of the contract liabilities, respectively, were classified as “Contract liabilities–short-term” in the accompanying consolidated balance sheets and none and $ 2.1 million of the contract liabilities, respectively, were classified as “Other long-term liabilities” in the accompanying consolidated balance sheets.
Contract liabilities consisted of the following:
3 unchanged sentences
Amounts recognized into revenue
−Removed: Amounts recognized into other (expense) income, net
Contract liabilities at December 31, 2023
6 unchanged sentences
dollars at exchange rates prevailing on the subsequent balance sheet date.
−Removed: Gains and losses as a result of translation adjustments are recorded within “Other (expense) income, net” in the accompanying consolidated statements of operations and comprehensive income (loss).
−Removed: During the years ended December 31, 2023, 2022 and 2021, the Company recorded a loss of $ 0.5 million, a gain of $ 0.7 million and a loss of $ 0.3 million, respectively, on foreign currency translation.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
+Added: Gains and losses as a result of translation adjustments are recorded within “Other income (expense), net” in the accompanying consolidated statements of operations and comprehensive income (loss).
+Added: During the years ended December 31, 2024, 2023 and 2022, the Company recorded losses of $ 0.8 million and $ 0.5 million and a gain of $ 0.7 million, respectively, on foreign currency translation.
Concentrations
Financial instruments that potentially subject the Company to concentrations of credit risk are receivables and marketable securities.
−Removed: Billings to large pharmaceutical companies and pharmaceutical wholesalers account for the majority of the Company’s receivables, and collateral is generally not required from these customers.
+Added: Billings to large pharmaceutical companies and pharmaceutical wholesalers account for the majority of the Company’s receivables, and collateral is not required from these customers.
To mitigate credit risk, the Company monitors the financial performance and credit-worthiness of its customers.
2 unchanged sentences
Cardinal Health
−Removed: AmerisourceBergen
Indicates the revenues or receivables for the customer did not exceed 10 % of the Company’s total in each category as of or for the years ended December 31, 2024, 2023 and 2022, as noted.
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Company holds its interest-bearing investments with major financial institutions and, in accordance with documented investment policies, the Company limits the amount of credit exposure to any one financial institution or corporate issuer.
−Removed: The Company’s investment objectives are, first, to ensure liquidity and conservation of capital and, second, to obtain investment income.
+Added: The Company’s investment objectives are, first, to ensure liquidity and conservation of capital and, second, to generate investment income.
Geographic Information
8 unchanged sentences
Current assets:
−Removed: Assets related to discontinued operations
+Added: Cash and cash equivalents
+Added: Investments—short-term
+Added: Receivables, net
Other current assets
+Added: Cash and cash equivalents
+Added: Investments—short-term
+Added: Receivables, net
Assets held for sale
Other current assets
−Removed: Rest of world
Long-term assets:
−Removed: Assets related to discontinued operations
−Removed: Intangible assets
−Removed: Assets held for sale
−Removed: (1) Prior period amounts have been retrospectively adjusted to reflect assets related to discontinued operations related to the Separation and assets held for sale related to the planned sale of the Athlone Facility.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
+Added: Property, plant and equipment, net
+Added: Investments—long-term
+Added: Property, plant and equipment, net
+Added: Investments—long-term
+Added: Intangible assets, net and goodwill
Research and Development Expenses
5 unchanged sentences
Selling, general and administrative (“SG&A”) expenses are primarily comprised of employee-related expenses associated with selling and marketing, finance, human resources, legal, information technology and other administrative personnel, outside marketing, advertising, financial and legal expenses and other general and administrative costs.
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Advertising costs are expensed as incurred.
6 unchanged sentences
Time-Based Stock Options
−Removed: Except as otherwise provided in the applicable Plan or award certificate, stock option grants to employees expire ten years from the date of grant and generally vest in four equal annual installments, commencing on the first anniversary of the date of grant, provided the employee remains continuously employed with the Company during the applicable vesting period.
−Removed: Except as otherwise provided in the applicable Plan:
−Removed: (i) annual stock option grants to non-employee directors expire ten years from the grant date and generally vest over a one-year period, provided that the director continues to serve on the Company’s board of directors through the vesting date;
−Removed: and (ii) stock option grants to new non-employee directors expire ten years from the grant date and generally vest over a three-year period, provided that the director continues to serve on the Company’s board of directors through the vesting date.
+Added: Except as otherwise provided in the applicable Plan or award certificate, stock option grants to employees expire ten years from the date of grant and generally vest in four equal annual installments, commencing on the first anniversary of the date of grant, provided the employee remains continuously employed or in a service relationship with the Company during the applicable vesting period.
+Added: Except as otherwise provided in the applicable Plan or Award Certificate (as defined in the 2018 Plan):
+Added: (i) annual stock option grants to non-employee directors expire ten years from the date of grant and generally vest over a one-year period;
+Added: and (ii) stock option grants to new non-employee directors expire ten years from the date of grant and generally vest over a three-year period.
The estimated fair value of options is recognized over the requisite service period, which is generally the vesting period.
19 unchanged sentences
Expected annual dividend yield
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Time-Based Restricted Stock Unit Awards
−Removed: Except as otherwise provided in the applicable Plan or award certificate, time-based RSUs awarded to employees generally vest in four equal annual installments, commencing on the first anniversary of the date of grant, provided the employee remains continuously employed with the Company during the applicable vesting period.
+Added: Except as otherwise provided in the applicable Plan or award certificate, time-based RSUs awarded to employees generally vest in four equal annual installments, commencing on the first anniversary of the date of grant, provided the employee remains continuously employed or in a service relationship with the Company during the applicable vesting period.
Shares subject to these RSUs are delivered to the employee upon vesting, subject to payment of applicable withholding taxes.
1 unchanged sentence
Compensation expense, including the effect of forfeitures, is recognized over the applicable service period.
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Performance-Based Restricted Stock Unit Awards
−Removed: Performance-based RSUs awarded to employees vest upon the achievement of certain performance criteria, typically during or at the end of a specified performance period.
−Removed: The estimated fair value of these RSUs are generally based on the closing price of the Company’s ordinary shares traded on the Nasdaq Global Select Market on the date of grant, unless the RSU is also subject to a market condition.
−Removed: In that case, the fair value of the RSU is based on a Monte Carlo simulation model.
+Added: Performance-based RSUs awarded to employees vest upon the achievement of certain performance criteria, typically during or following the end of a specified performance period.
+Added: The estimated fair value of these performance-based RSUs are generally based on the closing price of the Company’s ordinary shares traded on the Nasdaq Global Select Market on the date of grant, unless the performance-based RSU is also subject to a market condition.
+Added: In that case, the fair value of the performance-based RSU is based on a Monte Carlo simulation model.
Compensation expense for performance-based RSUs is recognized from the date the Company determines the performance criteria probable of being achieved to the date the award, or relevant portion of the award, is expected to vest.
Cumulative adjustments are recorded on a quarterly basis to reflect subsequent changes to the estimated outcome of the performance criteria until the date that the final outcome of the performance criteria is determined.
−Removed: Conversion and modification of equity awards outstanding at Separation date
−Removed: In connection with the Separation, and in accordance with the provisions of the Alkermes Stock Option and Incentive Plans (as defined in Note 15, Share-based Compensation ) and the terms of that certain employee matters agreement, dated as of November 13, 2023, as amended, by and between the Company and Mural (the “Employee Matters Agreement”), outstanding stock options, RSUs and performance-based RSUs were adjusted (an equitable adjustment) in order to preserve the intrinsic value of such awards immediately before and immediately after the Separation Date.
−Removed: Based upon the terms and the methodology set forth in the Employee Matters Agreement, one conversion ratio was calculated for awards held by current and former employees of the Company (the “Alkermes Conversion Ratio”), a second conversion ratio was calculated for stock options held by employees who transferred to Mural in connection with the Separation and a third conversion ratio was calculated for RSUs held by employees who transferred to Mural in connection with the Separation (the “Mural Conversion Ratios”).
−Removed: Following the application of the Alkermes Conversion Ratio to applicable awards that were outstanding immediately before the Separation Date, the Company compared the fair value of such awards to the fair value of the awards that were outstanding immediately after the Separation Date, as adjusted, to determine whether the Company would recognize an incremental fair value adjustment related to the awards.
−Removed: Following this calculation, it was determined that no incremental fair value resulted from the application of the Alkermes Conversion Ratio.
−Removed: Following the application of the applicable Mural Conversion Ratios to applicable awards that were outstanding immediately before the Separation Date, Mural compared the fair value of such awards to the fair value of the awards that were outstanding immediately after the Separation Date, as adjusted, to determine whether an incremental fair value adjustment was required.
−Removed: Following this calculation, it was determined that the fair value of the post-conversion awards held by employees who transferred to Mural increased immediately following the Separation, resulting in an incremental fair value charge as of the Separation Date.
−Removed: In accordance with FASB ASC 718, Compensation—Stock Compensation , the Company recognized a charge within share-based compensation expense of $ 1.6 million, which represented the incremental fair value related to stock option awards that had vested prior to the Separation Date.
The Company recognizes income taxes under the asset and liability method.
4 unchanged sentences
These assumptions require significant judgment about the forecasts of future taxable income and are consistent with the plans and estimates that the Company is using to manage the underlying business.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Company accounts for uncertain tax positions using a more-likely-than-not threshold for recognizing and resolving uncertain tax positions.
10 unchanged sentences
Segment Information
−Removed: The Company operates as one business segment, which is the business of developing, manufacturing and commercializing medicines designed to address unmet medical needs of patients in major therapeutic areas.
−Removed: The Company’s chief decision maker, the Chairman and Chief Executive Officer, reviews the Company’s operating results on an aggregate basis and manages the Company’s operations as a single operating unit.
+Added: In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting:
+Added: Improvements to Reportable Segment Disclosure (“Topic 280”) to establish standards for reporting information about operating segments.
+Added: Operating segments are defined as components of an enterprise engaging in business activities for which separate financial information is available and regularly reviewed by the chief operating decision maker (“CODM”) in deciding how to allocate resources and in assessing performance.
+Added: The Company has utilized the management approach to determine that the Company is managed as one segment on a consolidated basis and is the business of developing, manufacturing and commercializing medicines designed to address unmet medical needs of patients in major therapeutic areas.
+Added: The Company’s CODM, the Chairman and Chief Executive Officer, reviews the Company’s operating results on an aggregate basis and manages the Company’s operations as a single operating unit.
+Added: The CODM measures profitability on a reportable segment basis using net income (loss) and utilizes this information in allocating resources and in assessing performance by monitoring budget versus actual results.
+Added: Please refer to Note 18, Segment Reporting , in these “Notes to Consolidated Financial Statements” in this Annual Report for further information.
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Employee Benefit Plans
−Removed: The Company maintains a 401(k) retirement savings plan (the “401(k) Plan”), which covers substantially all of its U.S.-based employees.
+Added: The Company maintains a 401(k) retirement savings plan (the “401(k) Plan”), which covers all of its eligible U.S.-based employees.
Eligible employees may contribute up to 100 % of their eligible compensation, subject to certain Internal Revenue Service (“IRS”) limitations.
10 unchanged sentences
Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.
−Removed: In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280):
−Removed: Improvements to Reportable Segment Disclosure , which requires disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items to reconcile to segment profit or loss and the title and position of the Company’s chief operating decision maker.
−Removed: The amendments in this guidance also expand the interim segment disclosure requirements.
−Removed: All disclosure requirements under this guidance are required for public entities with a single reportable segment.
−Removed: This ASU became effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024.
−Removed: Early adoption is permitted and the amendments in this guidance are required to be applied on a retrospective basis.
−Removed: The Company is currently evaluating the potential impact this ASU will have on its consolidated financial statements and related disclosures.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
In December 2023, the FASB issued ASU 2023-09, Income Taxes (“Topic 740”) :
4 unchanged sentences
The Company is currently evaluating the impact this ASU will have on its consolidated financial statements and related disclosures.
+Added: In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income-Expense Disaggregation Disclosures , to improve disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation, amortization and depletion) in commonly-presented expense captions, such as cost of sales, selling, general and administrative expenses, and research and development.
+Added: All disclosure requirements under this guidance are required for public business entities and effective for annual periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027.
+Added: Early adoption is permitted and the amendments in this guidance will be applied prospectively to financial statements for periods after the effective dates.
+Added: The Company is currently evaluating the impact this ASU will have on its consolidated financial statements and related disclosures.
DISCONTINUED OPERATIONS
Mural Oncology Separation
−Removed: On November 15, 2023, the Company completed the Separation.
−Removed: In connection with the Separation, the Company entered into a separation agreement with Mural, dated as of November 13, 2023, that, among other things, sets forth the Company’s agreements with Mural regarding the principal actions taken or to be taken in connection with the Separation, including the Distribution.
+Added: In November 2023, the Company completed the Separation.
+Added: In connection with the Separation, the Company entered into a separation agreement with Mural, dated as of November 13, 2023, that, among other things, set forth the Company’s agreements with Mural regarding the principal actions taken or to be taken in connection with the Separation, including the Distribution.
The separation agreement identified those assets to be transferred to, liabilities to be assumed by and contracts to be assigned to Mural, including the operating lease for the office and laboratory space at 852 Winter Street in Waltham, Massachusetts, as part of the Separation, and it provided for when and how such transfers, assumptions and assignments were to occur.
The purpose of the separation agreement was to provide Mural and the Company with those assets necessary to operate their respective businesses and to retain or assume the respective liabilities related to those assets.
−Removed: Under the terms of the separation agreement, the Company granted Mural a perpetual, worldwide, non-exclusive, royalty-free, fully paid-up license (or, as the case may be, sublicense) to IP controlled by the Company as of the date of the Distribution to allow Mural to use such IP for the oncology business, and Mural granted the Company a perpetual, worldwide, non-exclusive, royalty-free, fully paid-up license (or, as the case may be, sublicense) to IP transferred to Mural as part of the Separation for the Company’s use outside of the oncology business.
Each of Mural and the Company agreed to releases with respect to pre-Distribution claims, and cross-indemnities with respect to post-Distribution claims, that are principally designed to place financial responsibility for the obligations and liabilities allocated to Mural under the separation agreement with Mural, and financial responsibility for the obligations and liabilities allocated to the Company under the separation agreement with the Company.
The Company and Mural are also each subject to mutual six-month employee non-solicitation and non-hire restrictions, subject to certain customary exceptions, and certain confidentiality restrictions and information sharing obligations.
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The transfer of assets and liabilities to Mural was effected through a contribution in accordance with the separation agreement, as summarized below:
16 unchanged sentences
In making such determinations, the Company applied U.S.
−Removed: federal tax law to
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: relevant facts and circumstances and obtained:
+Added: federal tax law to relevant facts and circumstances and obtained:
(i) a favorable private letter ruling from the IRS;
16 unchanged sentences
and the treatment of equity-based awards granted by the Company prior to the Separation.
−Removed: The Company entered into two transition services agreements with Mural.
−Removed: On November 13, 2023, Alkermes, Inc., a wholly-owned subsidiary of the Company (“Alkermes US”), and Mural Oncology, Inc., a wholly-owned subsidiary of Mural (“Mural US”), entered into one transition services agreement, pursuant to which the Company and its subsidiaries will provide, on an interim, transitional basis, various services to Mural and its subsidiaries, and a second transition services agreement, pursuant to which Mural and its subsidiaries will provide certain services to the Company and its subsidiaries, in each case for a term of two years , unless earlier terminated in accordance with the terms of the applicable agreement.
−Removed: As of December 31, 2023, the Company had an immaterial amount of accounts receivable and accounts payable due from and to Mural related to such transition services agreements.
Discontinued Operations
−Removed: The results of the oncology business and transaction costs related to the Separation have been reflected as “Loss from discontinued operations, net of taxes” in the accompanying consolidated statement of operations and comprehensive income (loss) through the Separation Date.
+Added: The results of the former oncology business and transaction costs related to the Separation have been reflected as “Loss from discontinued operations, net of taxes” in the accompanying consolidated statement of operations and comprehensive income (loss) through the Separation Date.
Prior periods have been recast to reflect this presentation.
The transaction costs related to the Separation were $ 36.0 million during 2023 and $ 1.4 million during 2022, and primarily relate to professional fees for separation activities within the finance, tax, legal and information technology functions.
−Removed: As of December 31, 2022, the assets and liabilities associated with the oncology business are classified as “Assets held for discontinued operations” and “Liabilities related to discontinued operations” in the accompanying consolidated balance sheet.
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The following table summarizes expenses of the discontinued operations for the years ended December 31, 2024, 2023 and 2022:
9 unchanged sentences
Net loss and comprehensive loss from discontinued operations
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
There were no assets and $ 4.5 million of liabilities related to the Separation as of December 31, 2023.
All assets were transferred to Mural as of the Separation Date.
−Removed: The $ 4.5 million of liabilities classified as “Liabilities related to discontinued operations” in the accompanying consolidated balance sheet relates to bonus amounts accrued for employees that transferred to Mural during 2023 through the Separation Date that will be paid by the Company, in accordance with the terms of the Employee Matters Agreement.
−Removed: The following table summarizes the assets and liabilities related to Mural that have been classified as assets and liabilities from discontinued operations in our accompanying consolidated balance sheet as of December 31, 2022:
−Removed: (In thousands)
−Removed: December 31, 2022
−Removed: Current Assets:
−Removed: Prepaid expenses and other current assets
−Removed: Total current assets
−Removed: Right-of-use assets
−Removed: Property, plant and equipment, net
−Removed: Deferred tax asset
−Removed: Assets from discontinued operations
−Removed: Current Liabilities:
−Removed: Operating lease liabilities—short-term
−Removed: Total current liabilities
−Removed: Operating lease liability—long-term
−Removed: Liabilities related to discontinued operations
+Added: The $ 4.5 million of liabilities classified as “Liabilities related to discontinued operations” in the accompanying consolidated balance sheet as of December 31, 2023 related to bonus amounts accrued for employees that transferred to Mural during 2023 through the Separation Date that were paid by the Company in the first quarter of 2024, in accordance with the terms of the employee matters agreement entered into between the Company and Mural.
The following table summarizes the significant non-cash items and capital expenditures of the discontinued operations that are included in the consolidated statements of cash flows for the years ended December 31, 2023 and 2022:
18 unchanged sentences
(In thousands)
−Removed: Manufacturing Revenue
−Removed: Royalty Revenue
+Added: Manufacturing
Long-acting INVEGA products (1)
2 unchanged sentences
(In thousands)
−Removed: Manufacturing Revenue
−Removed: Royalty Revenue
+Added: Manufacturing
Long-acting INVEGA products (1)
22 unchanged sentences
(“Acorda”) $ 16.5 million (inclusive of prejudgment interest and administrative fees) and $ 1.8 million (inclusive of prejudgment interest), respectively, previously paid by Acorda under a license agreement between the Company and Acorda.
−Removed: These amounts represented a portion of the royalty revenue paid to the Company by Acorda since July 2020 related to AMPYRA.
−Removed: The Company paid
+Added: These amounts
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: Acorda the aggregate $ 18.3 million in the fourth quarter of 2022.
+Added: represented a portion of the royalty revenue paid to the Company by Acorda since July 2020 related to AMPYRA.
+Added: The Company paid Acorda the aggregate $ 18.3 million in the fourth quarter of 2022.
In addition, during the three months ended June 30, 2022, the Company had recorded $ 3.2 million of royalty revenue related to AMPYRA as the Company believed that it had met the necessary revenue recognition criteria under Topic 606.
11 unchanged sentences
Corporate debt securities
−Removed: government debt securities
Total short-term investments
10 unchanged sentences
Available-for-sale securities:
−Removed: Corporate debt securities
government and agency debt securities
+Added: Corporate debt securities
government debt securities
2 unchanged sentences
Available-for-sale securities:
−Removed: Corporate debt securities
government and agency debt securities
−Removed: government debt securities
+Added: Corporate debt securities
Held-to-maturity securities:
6 unchanged sentences
At December 31, 2024, 77 of the Company’s 320 investment securities were in an unrealized loss position and had an aggregate estimated fair value of $ 112.7 million.
−Removed: Approximately 36 % and
+Added: Approximately 41 % and 59 % of the Company’s investment securities at December 31, 2024 were in corporate debt securities, with a minimum rating of A2
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: 61 % of the Company’s investment securities at December 31, 2023 were in corporate debt securities, with a minimum rating of A2 (Moody’s)/A (Standard and Poor’s), and debt securities issued by the U.S.
+Added: (Moody’s)/A (Standard and Poor’s), and debt securities issued by the U.S.
government or its agencies, respectively.
19 unchanged sentences
Corporate debt securities
−Removed: government debt securities
Cash equivalents
5 unchanged sentences
At December 31, 2024, the Company had no investments with fair values that were determined using Level 3 inputs.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Company’s investments in U.S.
3 unchanged sentences
The Company validated the prices developed using the market-observable data by obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active.
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
In April 2015, the Company sold its Gainesville, GA manufacturing facility, the related manufacturing and royalty revenue associated with certain products manufactured at the facility, and the rights to IV/IM and parenteral forms of Meloxicam to Recro Pharma, Inc.
1 unchanged sentence
The Gainesville Transaction included in the purchase price contingent consideration tied to low double digit royalties on net sales of the IV/IM and parenteral forms of Meloxicam and any other product with the same active ingredient as Meloxicam IV/IM that is discovered or identified using certain of the Company’s IP to which Recro was provided a right of use, through license or transfer, pursuant to the Gainesville Transaction (such products, the “Meloxicam Products”), and milestone payments upon the achievement of certain regulatory and sales milestones related to the Meloxicam Products.
−Removed: In November 2019, Recro Pharma, Inc.
−Removed: (“Recro”) spun out its acute care segment to Baudax Bio, Inc.
+Added: In November 2019, Recro spun out its acute care segment to Baudax Bio, Inc.
(“Baudax”), a publicly-traded pharmaceutical company.
2 unchanged sentences
In March 2022, Baudax reduced its workforce by approximately 80 %, which was designed to reduce its operational expenses and conserve its cash resources.
−Removed: In light of Baudax’s disclosures and the fact that, as of September 30, 2022, Baudax had only paid $ 1.2 million of the $ 6.4 million that was due to the Company in March 2022, the Company determined, during the three months ended September 30, 2022, that it was unlikely to collect any further proceeds under this arrangement and reduced the fair value of the contingent consideration to zero within “Change in the fair value of contingent consideration”.
−Removed: In addition, during the three months ended September 30, 2022, the Company determined that certain construction in progress related to the manufacture of ANJESO ® had no future value.
−Removed: See Note 8, Property, Plant and Equipment , within the “Notes to Consolidated Financial Statements” in this Annual Report for details related to such construction in progress.
+Added: In light of Baudax’s disclosures and the fact that, as of September 30, 2022, Baudax had only paid $ 1.2 million of the $ 6.4 million that was due to the Company in March 2022, the Company determined, during the three months ended September 30, 2022, that it was unlikely to collect any further proceeds under this arrangement and reduced the fair value of the contingent consideration to zero within “Change in the fair value of contingent consideration” in the accompanying consolidated statements of operations and comprehensive income (loss) for the year ended December 31, 2022.
+Added: In addition, during the three months ended September 30, 2022, the Company determined that certain construction in progress related to the manufacture of ANJESO ® had no future value and recorded a $ 2.3 million write off within “Other income (expense), net” in the accompanying consolidated statements of operations and comprehensive income (loss) for the year ended December 31, 2022.
In December 2022, Baudax announced that it would discontinue the sale of ANJESO and the U.S.
Food and Drug Administration (“FDA”) acknowledged the discontinuation of sale of ANJESO via listing in the Orange Book.
−Removed: The estimated fair value of the Company’s long-term debt under the 2026 Term Loans (as defined in Note 12, Long-Term Debt within these “Notes to Consolidated Financial Statements” in this Annual Report), which was based on quoted market price indications (Level 2 in the fair value hierarchy) and which may not be representative of actual values that could have been, or will be, realized in the future, was $ 291.0 million and $ 278.9 million at December 31, 2023 and 2022, respectively.
Inventory consists of the following:
5 unchanged sentences
(1) At December 31, 2024 and 2023, the Company had $ 22.7 million and $ 33.9 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
PROPERTY, PLANT AND EQUIPMENT
7 unchanged sentences
Total property, plant and equipment, net
−Removed: (1) In connection with the sale of the Athlone Facility, certain of the Company’s property, plant and equipment has been classified as “Assets held for sale” in the accompanying consolidated balance sheets at December 31, 2023 and 2022.
−Removed: In addition, certain prior period amounts have been retrospectively adjusted to reflect the effects of the Separation and classified as “Assets held for discontinued operations” in the accompanying consolidated balance sheet at December 31, 2022.
+Added: (1) In connection with the sale of the Athlone Facility, $ 92.2 million of the Company’s property, plant and equipment was classified as “Assets held for sale” in the accompanying consolidated balance sheet at December 31, 2023 and was not included in these amounts.
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Depreciation expens e was $ 27.4 million, $ 25.7 million and $ 26.3 million for the years ended December 31, 2024, 2023 and 2022, respectively.
2 unchanged sentences
The Company continues to evaluate its manufacturing capacity based on expectations of demand for its products and will continue to record such amounts within construction in progress until such time as the underlying assets are placed into service.
−Removed: The Company expects that approximately $ 30.6 million of construction in progress will be placed into service during 2024.
The Company continues to periodically evaluate whether facts and circumstances indicate that the carrying value of its long-lived assets to be held and used may not be recoverable.
−Removed: In September 2022, the Company determined that $ 8.7 million of its construction in progress that related to the manufacture of ANJESO had no future value.
−Removed: The Company had previously received $ 6.4 million from Baudax related to such equipment which it had recorded as contract liabilities within “Other long-term liabilities” in the accompanying consolidated balance sheets and the net amount of $ 2.3 million was written off through “other (expense) income, net” in the accompanying consolidated statements of operations and comprehensive income (loss) during the year ended December 31, 2022.
In December 2023, the Company determined that $ 2.9 million of its construction in progress at its Wilmington, Ohio manufacturing facility had no future value and was written off through “cost of goods manufactured and sold” in the accompanying consolidated statements of operations and comprehensive income (loss) during the year ended December 31, 2023.
−Removed: GOODWILL AND INTANGIBLE ASSETS
−Removed: Goodwill and intangible assets consists of the following:
+Added: INTANGIBLE ASSETS AND GOODWILL
+Added: Intangible assets and goodwill consists of the following:
December 31, 2024
11 unchanged sentences
Capitalized IP
−Removed: (1) In connection with the sale of the Athlone Facility, certain of the Company’s property, plant and equipment has been classified as “Assets held for sale” in the accompanying consolidated balance sheets at December 31, 2023 and 2022.
−Removed: In addition, certain prior period amounts have been retrospectively adjusted to reflect the effects of the Separation and classified as “Assets held for discontinued operations” in the accompanying consolidated balance sheet at December 31, 2022.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: The Company’s finite-lived intangible assets consist of collaborative agreements and the NanoCrystal and oral controlled release technologies acquired as part of the EDT acquisition.
+Added: In connection with the sale of the Athlone Facility, the Company reviewed Topic 805 and determined that the Athlone Facility constituted a business and, accordingly, $ 2.0 million of the Company’s goodwill was allocated to the Athlone Facility and was classified as “Assets held for sale” in the accompanying consolidated balance sheet as of December 31, 2023.
+Added: The Company’s finite-lived intangible assets primarily consisted of collaborative agreements and the NanoCrystal and oral controlled release technologies acquired as part of the EDT acquisition.
+Added: These intangible assets were fully amortized in the year ended December 31, 2024.
The Company recorded $ 1.1 million, $ 35.7 million and $ 36.4 million of amortization expense related to its finite-lived intangible assets during the years ended December 31, 2024, 2023 and 2022, respectively.
−Removed: The Company’s intangible assets included within its consolidated balance sheets at December 31, 2023 are expected to be fully amortized in the year ending December 31, 2024.
The Company performed its annual goodwill impairment test as of October 31, 2024.
−Removed: The Company performed a quantitative impairment test and based on the weight of all available evidence, determined that the fair value of the reporting unit exceeded its carrying value.
−Removed: As part of the assessment performed as of October 31, 2023, it was determined that a portion of the Company’s goodwill should be allocated to Mural, as a portion of the IP that transferred to Mural was owned by the reporting unit to which the Company’s goodwill was assigned.
−Removed: In connection with the completion of the Separation, the Company recorded a reduction in goodwill of $ 7.8 million in the accompanying consolidated balance sheet.
−Removed: In addition, in connection with the planned sale of the Athlone Facility, the Company reviewed FASB ASC 805, Business Combinations and determined that the Athlone Facility constitutes a business and, accordingly, $ 2.0 million of the Company’s goodwill was allocated to the Athlone Facility and is classified as “Assets held for sale” within the consolidated balance sheets as of December 31, 2023 and 2022.
+Added: The Company elected to perform a qualitative impairment test and determined that based on the weight of all available evidence, the fair value of the reporting unit more-likely-than-not exceeded its carrying value.
All of the Company’s leases are accounted for as operating leases.
1 unchanged sentence
The initial term of the lease commenced on January 20, 2020 , expires in 2035 and includes an option to extend the term for an additional ten-year period.
−Removed: On November 13, 2023, in connection with the Separation, Alkermes US and Mural US entered into an assignment and assumption of lease agreement (the “Assignment”), pursuant to which Alkermes US assigned to Mural US an operating lease for approximately 180,000 square feet of corporate office space, administrative areas and laboratories located at 852 Winter Street in Waltham, Massachusetts (the “852 Winter Street Lease”).
+Added: On November 13, 2023, in connection with the Separation, Alkermes, Inc., a wholly-owned subsidiary of the Company (“Alkermes US”) and Mural Oncology, Inc., a wholly-owned subsidiary of Mural (“Mural US”) entered into an assignment and assumption of lease agreement (the “Assignment”), pursuant to which Alkermes US assigned to Mural US an operating lease for approximately 180,000 square feet of corporate office space, administrative areas and laboratories located at 852 Winter Street in Waltham, Massachusetts (the “852 Winter Street Lease”).
Under the terms of the Assignment, Mural US assumed all of Alkermes US’ obligations under the 852 Winter Street Lease.
1 unchanged sentence
On November 15, 2023, the effective date of the Assignment, the Company reduced its right-of-use asset and lease liability by $ 14.5 million and $ 15.4 million, respectively in the accompanying consolidated balance sheet.
−Removed: In December 2022, the Company exercised an early payment option included within the terms of the 900 Winter Street Lease.
−Removed: The election of such early payment option resulted in a remeasurement of the remaining lease liability and right-of-use asset as of the remeasurement date of December 1, 2022 of $ 12.8 million.
−Removed: Subsequently, the Company made the early lease payment of $ 15.3 million in December 2022.
−Removed: As of December 31, 2022, the remeasurement and subsequent payment resulted in an increase in the right-of-use asset of $ 12.8 million and a net decrease in the lease liability of $ 2.5 million.
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
At December 31, 2024 and 2023, the operating leases held by the Company had a weighted average incremental borrowing rate of 4.0 % and 4.4 %, respectively, and a weighted average remaining lease term of 7.2 years and 8.7 years, respectively.
6 unchanged sentences
Total operating lease liabilities
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
13 unchanged sentences
LONG-TERM DEBT
−Removed: Long-term debt consists of the following:
+Added: In December 2024, the Company prepaid in full all previously outstanding term loans (the “Former Term Loans”) under the Former Credit Agreement without penalty, through paying off the remaining principal amount due of $ 289.5 million.
+Added: The Company accounted for such prepayment as a debt extinguishment and recorded a loss of approximately $ 0.8 million within “Other income (expense), net” in the accompanying consolidated statements of operations and comprehensive income (loss) for the year ended December 31, 2024.
+Added: The Former Term Loans bore interest at the Secured Overnight Financing Rate (“SOFR”) plus a credit spread adjustment applicable to the interest period and an applicable margin of 2.50 % with a floor of 0.5 %.
+Added: As of December 31, 2024 and 2023, long-term debt consisted of the following:
(In thousands)
−Removed: 2026 Term Loans, due March 12, 2026
+Added: Former Term Loans (due March 12, 2026)
current portion
Long-term debt
−Removed: The Company’s outstanding term loans mature on March 12, 2026 (the “2026 Term Loans”).
−Removed: In June 2023, the Company amended the 2026 Terms Loans to transition the interest rate available for borrowings thereunder from a London Interbank Offered Rate (“LIBOR”)-based interest rate to an interest rate based on the Secured Overnight Financing Rate (“SOFR”) and to make other conforming and mechanical changes.
−Removed: The 2026 Term Loans bear interest at SOFR plus a credit spread adjustment applicable to the interest period and an applicable margin of 2.50 % with a floor of 0.5 %.
−Removed: The 2026 Term Loans have an incremental facility capacity in the amount of $ 175.0 million plus additional potential amounts, provided that the Company meets certain conditions, including a specified leverage ratio.
−Removed: The 2026 Term Loans include a number of restrictive covenants that, among other things and subject to certain exceptions and baskets, impose operating and financial restrictions on the Company and certain of its subsidiaries.
−Removed: The 2026 Term Loans also contain customary affirmative covenants and events of default.
−Removed: The Company was in compliance with its debt covenants at December 31, 2023.
−Removed: Scheduled maturities with respect to the 2026 Term Loans are as follows (in thousands):
−Removed: Year Ending December 31:
−Removed: The Company is subject to mandatory prepayments of principal if certain excess cash flow thresholds, as defined in the 2026 Term Loans, are met.
−Removed: To date, the Company has not been required to make any such mandatory prepayments.
ALKERMES PLC AND SUBSIDIARIES
7 unchanged sentences
Net income (loss) from continuing operations
−Removed: Net (loss) discontinued operations
+Added: Net loss from discontinued operations
Net income (loss)
6 unchanged sentences
(1) Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation.
−Removed: The following potential ordinary share equivalents were not included in the net loss per share calculation because the effect would have been anti-dilutive:
+Added: The following potential ordinary share equivalents were not included in the net income (loss) per share calculation because the effect would have been anti-dilutive:
Year Ended December 31,
5 unchanged sentences
Share Repurchase Program
−Removed: On February 15, 2024, the Company’s board of directors authorized a share repurchase program to repurchase ordinary shares of the Company in an aggregate amount of up to $ 400.0 million (exclusive of any fees, commissions or other expenses related to such repurchases) from time to time (the “2024 Repurchase Program”).
−Removed: The timing and amount of any share repurchases under the 2024 Repurchase Program will be based on a variety of factors, including but not limited to ongoing assessments of the Company’s capital needs, alternative investment opportunities, the market price of the Company’s ordinary shares and general market conditions.
+Added: In February 2024, the Company’s board of directors approved a share repurchase program authorizing the Company to repurchase ordinary shares of the Company in an aggregate amount of up to $ 400.0 million (exclusive of any fees, commissions or other expenses related to such repurchases) from time to time on the open market (the “Repurchase Program”).
+Added: The specific timing and amounts of repurchases under the Repurchase Program will depend on a variety of factors, including but not limited to ongoing assessments of the Company’s needs, alternative investment opportunities, the market price of the Company’s ordinary shares and general market conditions.
The Repurchase Program has no set expiration date and may be suspended or discontinued at any time.
−Removed: The 2024 Repurchase Program terminates, and supersedes in its entirety, the Company’s prior share repurchase program authorized by its board of directors in September 2011 (the “Prior Repurchase Program”) under which the Company has purchased a total of 8,866,342 ordinary shares at a cost of $ 114.0 million.
−Removed: During the years ended December 31, 2023, 2022 and 2021 the Company did no t purchase any ordinary shares under the Prior Repurchase Program.
+Added: During the year ended December 31, 2024, the Company repurchased approximately 7.9 million of its ordinary shares under the Repurchase Program at an average price of $ 25.33 per share, resulting in a total cost, exclusive of any fees, commissions or other expenses related to such repurchase of $ 200.0 million.
+Added: All ordinary shares repurchased were returned to treasury.
+Added: As of December 31, 2024, the remaining amount authorized under the Repurchase Program was $ 200.0 million.
ALKERMES PLC AND SUBSIDIARIES
22 unchanged sentences
The 2018 Plan allows for the issuance of non-qualified and incentive stock options, restricted stock, restricted stock unit awards, cash-based awards and performance shares to employees, officers and directors of, and consultants to, the Company in such amounts and with such terms and conditions as may be determined by the compensation committee of the Company’s board of directors, subject to the provisions of the 2018 Plan, as applicable.
−Removed: On June 29, 2023, the Company’s shareholders approved an amended version of the Alkermes plc 2018 Stock Option and Incentive Plan that served to, among other things, increase the number of ordinary shares authorized for issuance thereunder by 6.5 million.
+Added: On May 31, 2024, the Company’s shareholders approved an amended version of the then-current version of the 2018 Plan that served to, among other things, increase the number of ordinary shares authorized for issuance thereunder by 6.3 million.
At December 31, 2024, there were 17.9 million ordinary shares available for issuance in the aggregate under the 2018 Plan.
The 2018 Plan provides that awards other than stock options will be counted against the total number of shares available under the plan in a 1.8 -to-1 ratio.
−Removed: In connection with the Separation and in accordance with the provisions of the Alkermes Stock Option and Incentive Plans, the Company adjusted outstanding equity awards as described in Note 2, Significant Accounting Policies within these “Notes to consolidated financial statements” in this Annual Report, and specifically the section entitled “Conversion and Modification of Equity Awards Outstanding at Separation Date”.
−Removed: The incremental number of ordinary shares underlying each award that was outstanding immediately prior to the Separation is included as “Conversion Reissuance” in each of the associated tables below.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Stock Options
3 unchanged sentences
Outstanding, January 1, 2024
−Removed: Conversion Reissuance
Outstanding, December 31, 2024
Exercisable, December 31, 2024
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The weighted average grant date fair value of stock options granted during the years ended December 31, 2024, 2023 and 2022 was $ 14.08 , $ 13.74 and $ 12.62 , respectively.
9 unchanged sentences
Unvested, January 1, 2024
−Removed: Conversion reissuance
Unvested, December 31, 2024
3 unchanged sentences
Performance-Based Restricted Stock Unit Awards
−Removed: In February 2023, 2022 and 2021, the compensation committee of the Company’s board of directors approved awards of performance-based RSUs to employees of the Company at the Senior Vice President level and above, in each case subject to vesting based on the achievement of certain financial, commercial and/or R&D performance criteria to be assessed over a performance period of three years from the date of the grant, and subject, at the end of such three-year performance period, to upward or downward adjustment based on a market condition tied to relative share price performance over the three-year performance period.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
+Added: In February 2024, 2023 and 2022, the compensation committee of the Company’s board of directors approved the Company’s long-term incentive plans, pursuant to which awards of performance-based RSUs are granted to employees of the Company at the Senior Vice President level and above, in each case subject to vesting based on the achievement of certain financial, commercial and/or R&D performance criteria to be assessed over a performance period of three years from the date of the grant, and subject, at the end of such three-year performance period, to upward or downward adjustment based on a market condition tied to relative share price performance over the three-year performance period.
A summary of performance-based RSU activity is presented in the following table:
1 unchanged sentence
Unvested, January 1, 2024
−Removed: Conversion reissuance
Unvested, December 31, 2024
The weighted average grant date fair values of performance-based RSUs granted during the years ended December 31, 2024, 2023 and 2022 were $ 32.46 , $ 29.91 and $ 30.73 , respectively.
−Removed: The total fair value of performance-based RSUs that vested during the years ended December 31, 2023, 2022 and 2021 were $ 5.9 million, none and $ 4.2 million, respectively.
−Removed: At December 31, 2023, there was $ 2.5 million of unrecognized share-based compensation expense related to performance-based RSUs granted in February 2022 and 2023, which would be recognized in accordance with the terms of the awards when the Company deems it probable that the performance criteria will be met.
−Removed: The Company has additional unrecognized share-based compensation expense related to performance-based RSUs that were granted in February 2021.
+Added: The total fair value of performance-based RSUs that vested during the years ended December 31, 2024, 2023 and 2022 were $ 10.1 million, $ 5.9 million and none , respectively.
+Added: At December 31, 2024, there
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
+Added: was $ 3.0 million of unrecognized share-based compensation expense related to unvested performance-based RSUs which would be recognized in accordance with the terms of the awards when the Company deems it probable that the performance criteria will be met.
+Added: During the year ended December 31, 2024, the Company recognized share-based compensation expense related to certain performance-based RSUs that were granted during 2021.
As of December 31, 2023, the financial performance criteria for these awards were deemed not probable of being achieved;
−Removed: On February 8, 2024, the compensation committee of the Company’s board of directors determined that the Company partially achieved the financial performance criteria.
+Added: however, in February 2024, the compensation committee of the Company’s board of directors determined that the Company partially achieved the financial performance criteria.
This was considered a modification in accordance with FASB ASC 718, Compensation—Stock Compensation and resulted in a modification charge of approximately $ 6.8 million.
−Removed: On February 8, 2024 , the compensation committee of the Company’s board of directors also determined that the Company achieved the pipeline performance criteria for these awards, resulting in a $ 2.6 million incremental share-based compensation expense, as it was deemed such pipeline performance criteria had been met.
−Removed: The share-based compensation expense related to these achievements will be recognized in 2024.
+Added: In February 2024 , the compensation committee of the Company’s board of directors also determined that the Company achieved the pipeline performance criteria for these awards, resulting in a $ 2.6 million incremental share-based compensation expense, as it was deemed such pipeline performance criteria had been met.
+Added: The share-based compensation expense related to these achievements was recognized in 2024.
COLLABORATIVE ARRANGEMENTS
7 unchanged sentences
The agreement also provides for tiered royalty payments, which consist of a patent royalty and a know-how royalty, both of which are determined on a country-by-country basis.
−Removed: The patent royalty, which equals 1.5 % of net sales, is payable in each country until the expiration of the last of the patents claiming the product in such country.
+Added: The patent royalty, which equals 1.5 % of net sales, is payable in each country until the expiration of the last of the patents with valid claims applicable to the product in such country.
The know-how royalty is a tiered royalty of 3.5 %, 5.5 % and 7.5 % on aggregate worldwide net sales of below $ 250 million, between $ 250 million and $ 500 million, and greater than $ 500 million, respectively.
5 unchanged sentences
The Company and Janssen have the right to terminate the agreement upon a material breach of the other party, which is not cured within a certain time period, or upon the other party’s bankruptcy or insolvency.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
In November 2021, the Company received notice from Janssen of partial termination of the license agreement, following which Janssen ceased paying the Company royalties related to U.S.
6 unchanged sentences
Under the development agreement, Janssen provided funding to the Company for the development of RISPERDAL CONSTA and Janssen is responsible for securing all necessary regulatory approvals for the product.
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Under two license agreements, the Company granted Janssen and an affiliate of Janssen exclusive worldwide licenses to use and sell RISPERDAL CONSTA.
15 unchanged sentences
Under a license and collaboration agreement with Biogen, the Company granted Biogen a worldwide, exclusive, sublicensable license to develop, manufacture and commercialize VUMERITY and other products covered by patents licensed to Biogen under the agreement.
−Removed: Under this license and collaboration agreement, the Company received an upfront cash payment and milestone payments related to the achievement of certain milestones, including FDA approval of the NDA for VUMERITY and amendment of the license and collaboration agreement.
+Added: Under this license and collaboration agreement, the Company received an upfront cash payment and milestone payments related to the achievement of certain milestones.
The Company is also eligible to receive additional payments upon achievement of certain milestones, including milestones relating to the first two products, other than VUMERITY, covered by patents licensed to Biogen under the license and collaboration agreement.
−Removed: In addition, the Company receives a 15 % royalty on worldwide net sales of VUMERITY, subject to increases for VUMERITY manufactured and/or packaged by Biogen or its designees, and subject to, under certain circumstances, minimum annual payments for the first five years following FDA approval of VUMERITY.
+Added: In addition, the Company receives a 15 % royalty on worldwide net sales of VUMERITY, subject to increases for VUMERITY manufactured and/or packaged by Biogen or its designees.
The Company is also entitled to receive royalties on net sales of products other than VUMERITY covered by patents licensed to Biogen under the license and collaboration agreement, at tiered royalty rates calculated as percentages of net sales ranging from high-single digits to sub-teen double digits.
All royalties are payable on a product-by-product and country-by-country basis until the later of (i) the last-to-expire patent right covering the applicable product in the applicable country and (ii) a specified period of time from the first commercial sale of the applicable product in the applicable country.
−Removed: Royalties for all products and the minimum annual payments for VUMERITY are subject to customary reductions, as set forth in the license and collaboration agreement.
+Added: Royalties for all products are subject to customary reductions, as set forth in the license and collaboration agreement.
+Added: Following FDA approval of VUMERITY and, except for the manufacturing responsibilities discussed below, Biogen is now responsible for all development and commercialization activities for VUMERITY and all other products covered by the patents that we licensed to Biogen.
+Added: Under the license and collaboration agreement, Biogen appointed the Company as the toll manufacturer of clinical and commercial supplies of VUMERITY, subject to Biogen’s right to manufacture or have manufactured commercial supplies as a back-up manufacturer.
+Added: In October 2019, the Company entered into a commercial supply agreement with Biogen for the commercial supply of VUMERITY, an amendment to such commercial supply agreement and an amendment to the license and collaboration agreement with Biogen, pursuant to which Biogen has conducted a technology transfer and, following an agreed transition period, has elected to assume responsibility for the manufacture (itself or through a designee) of clinical and commercial supplies of VUMERITY in exchange for an increase in the royalty rate to be paid by Biogen to the Company on net sales of product that is manufactured by Biogen or its designee.
+Added: In May 2024, the Company completed the sale of the Athlone Facility where VUMERITY is manufactured.
+Added: In connection with the sale of the Athlone Facility, the Company has entered into a subcontracting arrangement with the purchaser of the Athlone Facility for the manufacture of VUMERITY through the manufacturing transition period, which may continue through the end of 2025.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: Under the license and collaboration agreement, Biogen appointed the Company as the toll manufacturer of clinical and commercial supplies of VUMERITY, subject to Biogen’s right to manufacture or have manufactured commercial supplies as a back-up manufacturer and subject to good faith agreement by the parties on the terms of such manufacturing arrangements.
−Removed: In October 2019, the Company entered into a commercial supply agreement with Biogen for the commercial supply of VUMERITY, an amendment to such commercial supply agreement and an amendment to the license and collaboration agreement with Biogen, pursuant to which Biogen has elected to conduct a technology transfer and, following an agreed transition period, assume responsibility for the manufacture (itself or through a designee) of clinical supplies of VUMERITY and up to 100 % of commercial supplies of VUMERITY in exchange for an increase in the royalty rate to be paid by Biogen to the Company on net sales of that portion of product that is manufactured by Biogen or its designee.
Unless earlier terminated, the license and collaboration agreement will remain in effect until the expiry of all royalty obligations.
2 unchanged sentences
Upon termination of the license and collaboration agreement by either party, then, at the Company’s request, the VUMERITY program will revert to the Company.
−Removed: The Company’s (benefit) provision for income taxes from continuing operations consists of the following:
+Added: The Company’s provision (benefit) for income taxes from continuing operations consists of the following:
Year Ended December 31,
(In thousands)
−Removed: Current income tax (benefit) provision:
−Removed: Rest of world
−Removed: Deferred income tax (benefit) provision:
−Removed: Total tax (benefit) provision
+Added: Current income tax provision (benefit):
+Added: Deferred income tax provision (benefit):
+Added: Total tax provision (benefit)
(1) Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation.
+Added: The income tax provision in 2024 was primarily due to taxes on income earned in Ireland.
The income tax benefit in 2023 was primarily due to the partial release of the valuation allowance maintained against certain Irish deferred tax assets, partially offset by taxes on income earned in the U.S.
−Removed: The income tax provisions in 2022 and 2021 were primarily due to U.S.
−Removed: federal and state taxes on income earned in the U.S.
−Removed: and the tax impact of employee equity activity.
−Removed: In December 2023, the IRS issued Notice 2024-12 that provided clarity on the application of Section 174.
−Removed: On this basis, the Company adjusted its estimate of expenses that should be capitalized and amortized, resulting in lower taxable income and an elimination of the foreign derived intangible income (“FDII”) deduction for the year ended December 31, 2023.
−Removed: The income tax benefit associated with the Company’s oncology business, and the tax impact of the Separation, are discussed in further detail in Note 3, Discontinued Operations, in these “Notes to Consolidated Financial Statements” in this Annual Report.
+Added: The income tax expense in 2022 was primarily due to taxes on income earned in the U.S.
+Added: In December 2022, the EU implemented a new corporate minimum tax rate of 15 % on companies with consolidated annual revenue of at least € 750.0 million, which was transposed into Irish law effective as of January 1, 2024.
+Added: The Company has determined that this new minimum tax had no material impact for the year ended December 31, 2024.
+Added: The income tax benefit associated with the Company’s former oncology business, and the tax impact of the Separation, are discussed in further detail in Note 3, Discontinued Operations, in these “Notes to Consolidated Financial Statements” in this Annual Report.
The tax benefits included within discontinued operations were $ 0.7 million, $ 1.4 million, and $ 11.1 million for the years ended December 31, 2024, 2023, and 2022, respectively.
4 unchanged sentences
The Company estimates that approximately $ 72.0 million of income taxes would be payable on the repatriation of the unremitted earnings to Ireland.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: The distribution of the Company’s income (loss) before the (benefit) provision for income taxes by geographical area consists of the following:
+Added: The distribution of the Company’s income (loss) before the provision (benefit) for income taxes by geographical area consists of the following:
Year Ended December 31,
(In thousands)
−Removed: Income (loss) from continuing operations before (benefit) provision for income taxes
+Added: Income (loss) from continuing operations before provision (benefit) for income taxes
(1) Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation.
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The components of the Company’s net deferred tax assets consist of the following:
4 unchanged sentences
Accrued expenses and reserves
+Added: Operating lease liabilities
Share-based compensation
3 unchanged sentences
Property, plant and equipment
+Added: Right-of-use assets
Total deferred tax liabilities
Net deferred tax assets
−Removed: (1) Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation.
The activity in the valuation allowance associated with deferred taxes consists of the following:
6 unchanged sentences
Deferred tax asset valuation allowance for the year ended December 31, 2024
−Removed: (1) Inclusive of continuing and discontinued operations for all periods other than the balance at December 31, 2023.
−Removed: (2) (Additions) reductions represent continuing and discontinued operations.
−Removed: The reduction during the year ended December 31, 2023 primarily relates to the partial release of the valuation allowance maintained against certain Irish net deferred tax assets.
−Removed: The (additions) reductions in 2022 and 2021 relate primarily to Irish net operating losses (“NOLs”).
+Added: (1) Inclusive of continuing and discontinued operations for the periods prior to the Separation in November 2023.
+Added: (2) (Additions) reductions represent continuing and discontinued operations for the periods prior to the Separation in November 2023.
+Added: The reductions during the year ended December 31, 2024 primarily relate to the abandonment of certain Irish NOLs following the sale of the Athlone Facility to Novo.
+Added: These NOLs were transferred from Elan Corporation, plc as part of the combination of the drug technology business of Elan Corporation, plc with the business of Alkermes, Inc.
+Added: A number of restrictions applied to these NOLs thereby restricting the Company’s ability to utilize such NOLs.
+Added: Following the sale of the Athlone Facility, the Company believes that its ability to utilize these NOLs is remote.
+Added: The reduction during the year ended December 31, 2023 primarily relates to the partial release of the valuation allowance maintained by the Company against certain Irish net deferred tax assets.
+Added: The additions in 2022 relate primarily to Irish NOLs.
The Company regularly assesses the need for a valuation allowance against its deferred tax assets.
In making such assessment, the Company considers both positive and negative evidence related to the likelihood of realization of the deferred tax assets to determine, based on the weight of available evidence, whether it is more-likely-than-not that some or all of the deferred tax assets will not be realized.
−Removed: During the year ended December 31, 2023, the Company:
−Removed: (i) achieved a favorable outcome in its arbitration with Janssen (as described in Note 4, Revenue from Contracts with Customers in these “Notes to Consolidated Financial Statements” in this Annual Report);
−Removed: (ii) successfully completed the Separation;
−Removed: and (iii) recorded significant pre-tax income due to multiple factors, including the growth of its proprietary revenues and items (i) and (ii) above.
−Removed: As a result, the Company’s main operating subsidiary in Ireland recorded cumulative income during the year ended December 31, 2023 and the three-year period ended December 31, 2023.
−Removed: On this basis and other positive factors (such as anticipated future earnings) and negative factors (such as the potential decrease in certain manufacturing and royalty revenues), the Company has concluded that it is more-likely-than-not that certain Irish deferred tax assets will be realized.
−Removed: Of the $ 271.5 million valuation allowance maintained as of December 31, 2022, the Company released $ 143.9 million during the year ended December 31, 2023.
At December 31, 2024, the Company maintained a valuation allowance of $ 29.6 million against certain U.S.
state deferred tax assets and $ 50.1 million against certain Irish deferred tax assets, as the Company has determined that it is more-likely-than-not that these deferred tax assets will not be realized and some may be abandoned.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
If the Company incurs losses in the U.S.
−Removed: or in Ireland in the future, the evaluation of the recoverability of the deferred tax assets could change and a valuation allowance against such deferred tax assets may be required in part or in whole.
+Added: or in Ireland in the future, or fails to achieve sufficient profitability in a timely manner, the evaluation of the recoverability of the deferred tax assets could change and a valuation allowance against such deferred tax assets may be required in part or in whole.
The Company will continue to monitor the need for a valuation allowance against its deferred tax assets on a quarterly basis.
−Removed: As of December 31, 2023, the Company had $ 1.3 billion of Irish NOL carryforwards, $ 14.6 million of U.S.
−Removed: federal NOL carryforwards, $ 43.2 million of state NOL carryforwards, $ 9.7 million of federal R&D credits and $ 31.0 million of state tax credits which will either expire on various dates through 2043 or can be carried forward indefinitely.
+Added: As of December 31, 2024, the Company had $ 393.9 million of Irish NOL carryforwards, $ 14.1 million of U.S.
+Added: federal NOL carryforwards, $ 43.2 million of state NOL carryforwards and $ 34.0 million of state tax credits which will either expire on various dates through 2039 or can be carried forward indefinitely.
These loss and credit carryforwards are available to reduce certain future Irish and foreign taxable income and tax.
−Removed: These loss and credit carryforwards are subject to review and possible adjustment by the appropriate taxing authorities.
−Removed: These loss and credit carryforwards, which may be utilized in a future period, may be subject to limitations based upon changes in the ownership of the Company’s ordinary shares.
+Added: These loss and credit carryforwards are subject to review and possible adjustment by the appropriate taxing authorities and may be subject to limitations based upon changes in the ownership of the Company’s ordinary shares.
Included within these loss and credit carryforwards are $ 14.1 million of U.S.
federal NOL carryforwards and $ 5.8 million of state NOL carryforwards, acquired as part of the acquisition of Rodin Therapeutics, Inc.
−Removed: (“Rodin”), each of which are subject to a $ 0.5 million annual limitation.
+Added: in November 2019, each of which are subject to a $ 0.5 million annual limitation.
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
A reconciliation of the Company’s statutory tax rate to its effective tax rate is as follows:
12 unchanged sentences
federal benefit
−Removed: In-process R&D (5)
Foreign derived intangible income
+Added: Abandonment of NOLs (5)
Other permanent items (6)
−Removed: Income tax (benefit) provision
+Added: Income tax provision (benefit)
Effective tax rate
5 unchanged sentences
(4) Represents income or losses of Irish companies subject to tax at a rate other than the Irish statutory rate.
−Removed: (5) Represents the tax effect of the research and development expense recorded in connection with the acquisition of Rodin.
+Added: (5) Represents the tax effect of the abandonment of Irish NOLs following the sale of the Athlone Facility to Novo.
(6) Other permanent items include, but are not limited to, non-deductible meals and entertainment expenses and non-deductible compensation of senior officers of the Company.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
+Added: For the year ended December 31, 2024, permanent items also included amounts relating to the sale of the Athlone Facility.
A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows:
1 unchanged sentence
Balance, December 31, 2021
−Removed: Reductions based on tax positions related to prior periods
+Added: Reductions based on the lapse of applicable statutes of limitations
+Added: Additions based on tax positions related to prior periods
Additions based on tax positions related to the current period
1 unchanged sentence
Reductions based on the lapse of applicable statutes of limitations
−Removed: Additions based on tax positions related to prior periods
+Added: Additions based on tax positions related to the prior period
Additions based on tax positions related to the current period
8 unchanged sentences
For the years ended December 31, 2024, 2023 and 2022, the Company’s accrued interest and penalties related to uncertain tax positions were not material.
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Company’s major taxing jurisdictions include Ireland and the U.S.
6 unchanged sentences
These years generally remain open for three to four years after the loss carryforwards and credit carryforwards have been utilized.
−Removed: The years ended December 31, 2018 and 2017 for Alkermes Finance S.à.r.l, a former indirect subsidiary of Alkermes plc that was liquidated during the year ended December 31, 2020, are currently under examination by the Tax Authorities in Luxembourg (the “LTA”).
−Removed: In February 2023, the Company submitted an appeal to the LTA against the notice of assessment received in 2022 for the year ended December 31, 2017.
−Removed: In the third quarter of 2023, the Company received confirmation that the LTA changed its position and agreed to the originally filed tax return, resulting in the closure of the examination of the year ended December 31, 2017.
−Removed: In connection with the closure, the Company received a refund of approximately € 2.2 million from the LTA.
−Removed: As of December 31, 2023, the Company had no t received a notice of assessment from the LTA in relation to the year ended December 31, 2018.
−Removed: RESTRUCTURING
−Removed: In July 2023 , in conjunction with the Company’s ongoing review of operations and the Separation, the Company implemented a restructuring plan, which included the elimination of approximately 60 positions across the Company (the “Restructuring”).
−Removed: The Company recorded a charge of $ 6.0 million during the third quarter of 2023 as a result of the Restructuring, which consisted of one-time termination benefits for employee severance, benefits and related costs, all of which are expected to result in cash expenditures, and all of which are expected to be paid within 12 months of the Restructuring.
−Removed: The Company recognized $ 4.5 million and $ 1.5 million of this expense in R&D expense and SG&A expense, respectively, in the accompanying consolidated statements of comprehensive income (loss).
−Removed: Activity related to the Restructuring during the year ended December 31, 2023 was as follows:
+Added: SEGMENT REPORTING
+Added: Segment Information
+Added: Following the adoption of ASU 2023-07, the Company is required to disclose significant segment expenses that are regularly provided to the CODM.
+Added: The Company’s CODM is periodically provided R&D expenses, selling and marketing expenses, and general and administrative expenses.
+Added: Other external R&D expenses are composed of general research and development expenses and other external projects.
+Added: Other internal R&D expenses include allocation expenses, travel expenses, and fees, taxes and dues.
+Added: The Company’s significant segment expenses are as follows:
+Added: Year Ended December 31,
(In thousands)
−Removed: Balance, December 31, 2022
−Removed: Restructuring charge
−Removed: Amounts paid during the period:
−Removed: Outplacement services
−Removed: Balance, December 31, 2023
+Added: Total revenue
+Added: Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below)
+Added: External R&D expenses:
+Added: Development programs:
+Added: Other external R&D expenses
+Added: Total external R&D expenses
+Added: Internal R&D expenses:
+Added: Employee-related
+Added: Other internal R&D expenses
+Added: Total internal R&D expenses
+Added: Selling, general and administrative expenses:
+Added: Selling and marketing expense
+Added: General and administrative expense
+Added: Total selling, general and administrative expense
+Added: Other segment (expenses) income (1)
+Added: NET INCOME (LOSS) FROM CONTINUING OPERATIONS
+Added: LOSS ON DISCONTINUED OPERATIONS, NET OF TAX
+Added: NET INCOME (LOSS)
+Added: (1) “Other segment (expenses) income” during the years ended December 31, 2024, 2023 and 2022 includes “Amortization of acquired intangible assets”, “Other income (loss), net” and “Income tax provision (benefit)”.
ALKERMES PLC AND SUBSIDIARIES
7 unchanged sentences
At December 31, 2024, there were no potential material losses from claims, asserted or unasserted, or legal proceedings that the Company determined were probable of occurring.
−Removed: INVEGA SUSTENNA ANDA Litigation
−Removed: Janssen Pharmaceutica and Janssen Pharmaceuticals, Inc.
−Removed: initiated patent infringement lawsuits in the U.S.
−Removed: District Court for the District of New Jersey (the “NJ District Court”) in January 2018 against Teva Pharmaceuticals USA, Inc.
−Removed: (“Teva”) and Teva Pharmaceuticals Industries, Ltd.
−Removed: (“Teva PI”) (such lawsuit, the “Teva Lawsuit”), in August 2019 against Mylan Laboratories Limited (“Mylan Labs”) and other Mylan entities (the “Mylan Lawsuit”), in December 2019 against Pharmascience, Inc.
−Removed: (“Pharmascience”), Mallinckrodt plc, and SpecGX LLC (the “Pharmascience Lawsuit”), and in February 2022 against Accord Healthcare, Inc., Accord Healthcare, Ltd.
−Removed: and Intas Pharmaceuticals, Ltd (“Accord” and such lawsuit, the “Accord Lawsuit”), and in the U.S.
−Removed: District Court for the District of Delaware (the “DE District Court”) in December 2021 against Tolmar Holding, Inc., Tolmar Pharmaceuticals, Inc., Tolmar Therapeutics, Inc., and Tolmar, Inc.
−Removed: (“Tolmar” and such lawsuit, the “Tolmar Lawsuit”), following the respective filings by each of Teva, Mylan Labs, Pharmascience, Accord and Tolmar of an Abbreviated New Drug Application (“ANDA”) seeking approval from the FDA to market a generic version of INVEGA SUSTENNA before the expiration of U.S.
−Removed: In October 2021, the NJ District Court entered a judgment in favor of the Janssen entities in the Teva Lawsuit.
−Removed: In December 2021, the NJ District Court entered a judgment in favor of the Janssen entities in the Mylan Lawsuit, based on the parties’ prior stipulation to be bound by the judgment in the Teva Lawsuit.
−Removed: The Teva entities and Mylan Labs each filed notices of appeal of their respective judgments with the U.S.
−Removed: Court of Appeals for the Federal Circuit, which were consolidated in January 2022 (the “Teva Appeal”).
−Removed: A trial was held in the Tolmar Lawsuit in October 2023.
−Removed: The Pharmascience Lawsuit and the Accord Lawsuit were administratively terminated in July 2022, pending the outcome of the Teva Appeal.
−Removed: The Company is not a party to any of these proceedings.
INVEGA TRINZA ANDA Litigation
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Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”).
−Removed: In October 2023, Zydus filed an answer to the complaint.
+Added: A bench trial is scheduled to begin on July 28, 2025.
Government Matters
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The Company is cooperating with the investigations.
−Removed: ALKERMES PLC AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Product Liability and Other Legal Proceedings
−Removed: The Company is involved in litigation and other legal proceedings incidental to its normal business activities, including product liability cases alleging that the FDA-approved VIVITROL labeling was inadequate and caused the users of the product to suffer from opioid overdose and death.
+Added: The Company is involved in litigation and other legal proceedings incidental to its normal business activities, including a product liability case alleging that the FDA-approved VIVITROL labeling was inadequate and that VIVITROL caused the individual to suffer from opioid overdose and death.
The Company intends to vigorously defend itself in these matters.
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In September 2023, Acorda filed a notice of appeal of the NY Southern District Court decision to the U.S.
−Removed: Court of Appeals for the Federal Circuit (the “Federal Circuit”), and the Company filed a motion to transfer the appeal to the U.S.
+Added: Court of Appeals for the Federal Circuit (the “Federal Circuit Court”), and the Company filed a motion to transfer the appeal to the U.S.
Court of Appeals for the Second Circuit.
−Removed: On October 10, 2023, Acorda filed an opposition to such motion.
−Removed: On January 18, 2024, the Federal Circuit denied without prejudice the Company’s motion to transfer the appeal and instructed the parties to brief the jurisdictional question as part of the merits appeal.
−Removed: While the outcome of any of these proceedings cannot be accurately predicted, the Company does not believe the ultimate resolution of any of these existing proceedings would have a material adverse effect on the Company’s business or financial condition.
+Added: In January 2024, the Federal Circuit Court denied without prejudice the Company’s motion to transfer the appeal and instructed the parties to brief the jurisdictional question as part of the merits appeal.
+Added: Briefing in the Federal Circuit Court is complete, and the matter is pending decision.
+Added: ALKERMES PLC AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
In connection with the Separation, the Company entered into the Assignment related to the 852 Winter Street Lease, which is described in more detail in Note 10, Leases in these “Notes to Consolidated Financial Statements” in this Annual Report.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.