Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Disclosure Controls and Procedures and Internal Control Over Financial Reporting
Controls and Procedures
Our management has evaluated, with the participation of our principal executive officer and principal financial officer, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of December 31, 2023. Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective to provide reasonable assurance that (a) the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (b) such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the quarter ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over our financial reporting as defined in Rules 13a-15(f) and 15d-15(f). Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as a process designed by, or under the supervision of, the issuer’s principal executive and principal financial officers, or persons performing similar functions, and effected by the issuer’s board of directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP and includes those policies and procedures that:
• pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of the assets of the issuer;
• provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that receipts and expenditures of the issuer are being made only in accordance with authorizations of management and directors of the issuer; and
• provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the issuer’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness for future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2023. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in its 2013 Internal Control—Integrated Framework.
Based on this assessment, our management has concluded that, as of December 31, 2023, our internal control over financial reporting was effective.
The effectiveness of our internal control over financial reporting as of December 31, 2023 has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report, which is included in this Annual Report, beginning on page F-1.
Item 9B. Other Information
Trading Plans
70
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”): 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); this plan is scheduled to expire on July 31, 2025 . 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; this plan is scheduled to expire on August 2, 2024 . 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.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
71
PART III
Item 10. Directors, Executive Of ficers and Corporate Governance
The information required by this item is incorporated herein by reference to our definitive proxy statement for our 2024 annual general meeting of shareholders.
Item 11. 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 2024 annual general meeting of shareholders.
Item 12. 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 2024 annual general meeting of shareholders.
Item 13. 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 2024 annual general meeting of shareholders.
Item 14. Principal Accou nting Fees and Services
The information required by this item is incorporated herein by reference to our definitive proxy statement for our 2024 annual general meeting of shareholders.
72
PART IV
Item 15. Exhibits and Fina ncial Statement Schedules
(a)(1) Consolidated Financial Statements—The consolidated financial statements of Alkermes plc, as required by this item, are submitted in a separate section beginning on page F-1 of this Annual Report, as follows:
Financial Statement
Page Number
Report of Independent Registered Public Accounting Firm (PCAOB ID: 238 )
F- 1
Consolidated Balance Sheets
F- 4
Consolidated Statements of Operations and Comprehensive Income (Loss)
F- 5
Consolidated Statements of Shareholders’ Equity
F- 6
Consolidated Statements of Cash Flows
F- 7
Notes to the Consolidated Financial Statements
F- 8
(2) Financial Statement Schedules—All schedules have been omitted because the absence of conditions under which they are required or because the required information is included in the consolidated financial statements or notes thereto.
(3) The exhibits listed in the below Exhibit Index are filed or furnished as part of this Annual Report or are incorporated into this Annual Report by reference.
EXHIBIT INDEX
Incorporated by reference herein
Exhibit No.
Description of Exhibit
Form
Date
2.1 # §§
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. in November 2019).
2.2 ** §
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.
Exhibit 2.1 to the Alkermes plc Current Report on Form 8-K (File No. 001-35299)
November 25, 2019
2.3 §
Separation Agreement, dated as of November 13, 2023, by and between Alkermes plc and Mural Oncology plc.
Exhibit 2.1 to the Alkermes plc Current Report on Form 8-K (File No. 001-35299)
November 15, 2023
3.1 #
Memorandum and Articles of Association of Alkermes plc.
4.1 #
Description of Securities.
10.1
Lease between Alkermes, Inc. and PDM Unit 850, LLC, dated as of April 22, 2009.
Exhibit 10.5 to the Alkermes, Inc. Annual Report on Form 10-K (File No. 001-14131)
May 28, 2009
10.1A
First Amendment to Lease between Alkermes, Inc. and PDM Unit 850, LLC, dated as of June 18, 2009.
Exhibit 10.2 to the Alkermes, Inc. Quarterly Report on Form 10-Q (File No. 001-14131)
August 6, 2009
10.1B
Second Amendment to Lease between Alkermes, Inc. and PDM Unit 850, LLC, dated as of November 12, 2013.
Exhibit 10.74 to the Alkermes plc Transition Report on Form 10-KT (File No. 001-35299)
February 27, 2014
10.1C
Third Amendment to Lease between Alkermes, Inc. and PDM 850 Unit, LLC, dated as of May 15, 2014.
Exhibit 10.2 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
July 31, 2014
10.1D
Fourth Amendment to Lease between Alkermes, Inc. and GI TC 850 Winter Street, LLC, dated as of December 30, 2014.
Exhibit 10.7 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
July 30, 2015
10.1E
Fifth Amendment to Lease between Alkermes, Inc. and GI TC 850 Winter Street, LLC, dated as of October 31, 2018.
Exhibit 10.1.5 to the Alkermes plc Annual Report on Form 10-K (File No. 001-35299)
February 15, 2019
73
Incorporated by reference herein
Exhibit No.
Description of Exhibit
Form
Date
10.1F
Sixth Amendment to Lease between Alkermes, Inc. and GI TC 850 Winter Street, LLC, dated as of July 24, 2020.
Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
October 29, 2020
10.2
License Agreement, dated as of February 13, 1996, between Medisorb Technologies International L.P. and Janssen Pharmaceutica Inc. (United States) (assigned to Alkermes, Inc. in July 2006).
Exhibit 10.2 to the Alkermes plc Annual Report on Form 10-K (File No. 001-35299)
February 25, 2016
10.2A *
Third Amendment to Development Agreement, Second Amendment to Manufacturing and Supply Agreement and First Amendment to License Agreements by and between Janssen Pharmaceutica International, Janssen Pharmaceutica Inc. and Alkermes Controlled Therapeutics Inc. II, dated April 1, 2000 (assigned to Alkermes, Inc. in July 2006).
Exhibit 10.5 to the Alkermes, Inc. Quarterly Report on Form 10-Q (File No. 001-14131)
February 8, 2005
10.2B *
Second Amendment, dated as of August 16, 2012, to the License Agreement, dated as of February 13, 1996, as amended, by and between Alkermes, Inc. and Janssen Pharmaceutica Inc. and the License Agreement, dated as of February 21, 1996, as amended, by and between Alkermes, Inc. and JPI Pharmaceutica International, and the Fifth Amendment, dated as of August 16, 2012, to the Manufacturing and Supply Agreement, dated as of August 6, 1997, as amended, by and between Alkermes, Inc., Janssen Pharmaceutica Inc. and JPI Pharmaceutica International.
Exhibit 10.3 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
November 1, 2012
10.3
License Agreement, dated as of February 21, 1996, between Medisorb Technologies International L.P. and Janssen Pharmaceutica International (worldwide except United States) (assigned to Alkermes, Inc. in July 2006).
Exhibit 10.3 to the Alkermes plc Annual Report on Form 10-K (File No. 001-35299)
February 25, 2016
10.4
Manufacturing and Supply Agreement, dated August 6, 1997, by and among JPI Pharmaceutica International, Janssen Pharmaceutica, Inc. and Alkermes Controlled Therapeutics Inc. II (assigned to Alkermes, Inc. in July 2006).
Exhibit 10.4 to the Alkermes plc Annual Report on Form 10-K (File No. 001-35299)
February 25, 2016
10.4A *
Fourth Amendment to Development Agreement and First Amendment to Manufacturing and Supply Agreement by and between Janssen Pharmaceutica International, Janssen Pharmaceutica Products, L.P. and Alkermes Controlled Therapeutics Inc. II, dated December 20, 2000 (assigned to Alkermes, Inc. in July 2006).
Exhibit 10.4 to the Alkermes, Inc. Quarterly Report on Form 10-Q (File No. 001-14131)
February 8, 2005
10.4B
Addendum to the Manufacturing and Supply Agreement by and among JPI Pharmaceutica International, Janssen Pharmaceutica Inc. and Alkermes Controlled Therapeutics Inc. II, dated August 1, 2001.
Exhibit 10.4.2 to the Alkermes plc Annual Report on Form 10-K (File No. 001-35299)
February 25, 2016
10.4C
Letter Agreement and Exhibits to Manufacturing and Supply Agreement, dated February 1, 2002, by and among JPI Pharmaceutica International, Janssen Pharmaceutica Inc. and Alkermes Controlled Therapeutics Inc. II (assigned to Alkermes, Inc. in July 2006).
Exhibit 10.4.3 to the Alkermes plc Annual Report on Form 10-K (File No. 001-35299)
February 25, 2016
10.4D *
Amendment to Manufacturing and Supply Agreement by and between JPI Pharmaceutica International, Janssen Pharmaceutica Inc. and Alkermes Controlled Therapeutics Inc. II, dated December 22, 2003 (assigned to Alkermes, Inc. in July 2006).
Exhibit 10.6 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 011-35299)
July 30, 2015
10.4E *
Fourth Amendment to Manufacturing and Supply Agreement by and between JPI Pharmaceutica International, Janssen Pharmaceutica Inc. and Alkermes Controlled Therapeutics Inc. II, dated January 10, 2005 (assigned to Alkermes, Inc. in July 2006).
Exhibit 10.9 to the Alkermes, Inc. Quarterly Report on Form 10-Q (File No. 001-14131)
February 8, 2005
10.4F *
Sixth Amendment to Manufacturing and Supply Agreement by and between JPI Pharmaceutica International, Janssen Pharmaceutica Inc. and Alkermes Controlled Therapeutics Inc.
Exhibit 10.11 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 011-35299)
October 23, 2018
74
Incorporated by reference herein
Exhibit No.
Description of Exhibit
Form
Date
II (assigned to Alkermes, Inc. in July 2006), effective as of July 1, 2018.
10.5 # §§
Development and License Agreement, dated as of May 15, 2000, by and between Alkermes Controlled Therapeutics Inc. II and Amylin Pharmaceuticals, Inc., as amended on October 24, 2005 and July 17, 2006 (assigned, as amended, to Alkermes, Inc. in July 2006).
10.5A # §§
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. 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.
10.6 *
Agreement by and between JPI Pharmaceutica International, Janssen Pharmaceutica Inc. and Alkermes Controlled Therapeutics Inc. II, dated December 21, 2002 (assigned to Alkermes, Inc. in July 2006).
Exhibit 10.6 to the Alkermes, Inc. Quarterly Report on Form 10-Q (File No. 001-14131)
February 8, 2005
10.6A *
Amendment to Agreement by and between JPI Pharmaceutica International, Janssen Pharmaceutica Inc. and Alkermes Controlled Therapeutics Inc. II, dated December 16, 2003 (assigned to Alkermes, Inc. in July 2006).
Exhibit 10.7 to the Alkermes, Inc. Quarterly Report on Form 10-Q (File No. 001-14131)
February 8, 2005
10.7 **
License Agreement by and among Elan Pharmaceutical Research Corp., d/b/a Nanosystems and Elan Pharma International Limited and Janssen Pharmaceutica N.V. dated as of March 31, 1999.
Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
April 26, 2023
10.7A
First Amendment, dated as of July 31, 2003, to the License Agreement by and among Elan Drug Delivery, Inc. (formerly Elan Pharmaceutical Research Corp.) and Elan Pharma International Limited and Janssen Pharmaceutica NV dated March 31, 1999.
Exhibit 10.24 to the Alkermes plc Annual Report on Form 10-K (File No. 001-35299)
May 23, 2013
10.7B **
Agreement Amendment No. 2, dated as of July 31, 2009, to the License Agreement by and among Elan Pharmaceutical Research Corp., d/b/a Nanosystems and Elan Pharma International Limited and Janssen Pharmaceutica N.V. dated as of March 31, 1999, as amended by the First Amendment, dated as of July 31, 2003.
Exhibit 10.2 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
April 26, 2023
10.8
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. as Administrative Agent and Collateral Agent and the arrangers and agents party thereto.
Exhibit 10.1 to the Alkermes plc Current Report on Form 8-K (File No. 011-35299)
September 25, 2012
10.8A
Amendment No. 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. as Administrative Agent and Collateral Agent and the arrangers and agents party thereto.
Exhibit 10.1 to the Alkermes plc Current Report on Form 8-K (File No. 011-35299)
February 19, 2013
10.8B
Amendment No. 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. as Administrative Agent and Collateral Agent and the lenders party thereto.
Exhibit 10.52 to the Alkermes plc Annual Report on Form 10-K (File No. 011-35299)
May 23, 2013
10.8C
Amendment No. 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
Exhibit 10.2 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 011-35299)
November 2, 2016
75
Incorporated by reference herein
Exhibit No.
Description of Exhibit
Form
Date
amended by Amendment No. 2 on February 14, 2013 and as amended by Amendment No. 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. as Administrative Agent and Collateral Agent.
10.8D
Amendment No. 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. 2 on February 14, 2013, as amended by Amendment No. 3 and Waiver to Amended and Restated Credit Agreement dated as of May 22, 2013, and as amended by Amendment No. 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. as Administrative Agent and Collateral Agent.
Exhibit 10.5 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 011-35299)
April 26, 2018
10.8E
Amendment No. 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. 2 on February 14, 2013, as amended by Amendment No. 3 and Waiver to Amended and Restated Credit Agreement dated as of May 22, 2013, as amended by Amendment No. 4, dated as of October 12, 2016, and as amended by Amendment No. 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. as Administrative Agent and Collateral Agent.
Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 011-35299)
April 28, 2021
10.8F
Amendment No. 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. 2 on February 14, 2013, as amended by Amendment No. 3 and Waiver to Amended and Restated Credit Agreement dated as of May 22, 2013, as amended by Amendment No. 4, dated as of October 12, 2016, as amended by Amendment No. 5, dated as of March 26, 2018, and as amended by Amendment No. 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. as Administrative Agent and Collateral Agent.
Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 011-35299)
July 26, 2023
10.9 *
License and Collaboration Agreement, dated November 27, 2017, by and between Alkermes Pharma Ireland Limited and Biogen Swiss Manufacturing GmbH.
Exhibit 10.10 to the Alkermes plc Annual Report on Form 10-K (File No. 011-35299)
February 16, 2018
10.9A *
First Amendment to License and Collaboration Agreement between Alkermes Pharma Ireland Limited and 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. 011-35299)
October 23, 2018
10.9B
Second Amendment to License and Collaboration Agreement between Alkermes Pharma Ireland Limited and 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. 011-35299)
April 25, 2019
10.9C **
Third Amendment to License and Collaboration Agreement between Alkermes Pharma Ireland Limited and 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. 011-35299)
February 13, 2020
10.9D **
Fourth Amendment to License and Collaboration Agreement between Alkermes Pharma Ireland Limited and 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. 011-35299)
November 2, 2022
10.10
Lease, dated March 23, 2018, by and between Alkermes, Inc. and PDM 900 Unit, LLC.
Exhibit 10.4 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 011-35299)
April 26, 2018
76
Incorporated by reference herein
Exhibit No.
Description of Exhibit
Form
Date
10.10A
First Amendment to Lease, dated June 21, 2018, by and between Alkermes, Inc. and PDM 900 Unit, LLC.
Exhibit 10.2 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
July 26, 2018
10.10B
Second Amendment to Lease, dated May 10, 2019, by and between Alkermes, Inc. and PDM 900 Unit, LLC.
Exhibit 10.2 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
July 25, 2019
10.11 **
Confidential Settlement and License Agreement, dated August 29, 2023, by and among Alkermes, Inc., Alkermes Pharma Ireland Limited and Teva Pharmaceuticals USA, Inc.
Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
October 25, 2023
10.12 §
Tax Matters Agreement, dated November 13, 2023, by and between Alkermes plc and Mural Oncology plc.
Exhibit 10.1 to the Alkermes plc Current Report on Form 8-K (File No. 001-35299)
November 15, 2023
10.13 §
Employee Matters Agreement, dated November 13, 2023, by and between Alkermes plc and Mural Oncology plc.
Exhibit 10.2 to the Alkermes plc Current Report on Form 8-K (File No. 001-35299)
November 15, 2023
10.13A #
Amendment to Employee Matters Agreement, dated December 14, 2023, by and between Alkermes plc and Mural Oncology plc.
10.14 §
Transition Services Agreement, dated November 13, 2023, by and between Alkermes, Inc. and Mural Oncology, Inc.
Exhibit 10.3 to the Alkermes plc Current Report on Form 8-K (File No. 001-35299)
November 15, 2023
10.15 §
Transition Services Agreement, dated November 13, 2023, by and between Mural Oncology, Inc. and Alkermes, Inc.
Exhibit 10.4 to the Alkermes plc Current Report on Form 8-K (File No. 001-35299)
November 15, 2023
10.16 # ** §
Asset Purchase Agreement, dated December 13, 2023, by and between Alkermes Pharma Ireland Limited, Novo Nordisk Production Ireland Limited and Novo Nordisk A/S.
10.17
Employment Agreement, dated as of December 12, 2007, by and between Richard F. Pops and Alkermes, Inc.
Exhibit 10.1 to the Alkermes, Inc. Quarterly Report on Form 10-Q (File No. 001-14131)
February 11, 2008
10.17A
Amendment to Employment Agreement, dated as of October 7, 2008, by and between Alkermes, Inc. and Richard F. Pops.
Exhibit 10.5 to the Alkermes, Inc. Current Report on Form 8-K (File No. 001-14131)
October 7, 2008
10.17B
Amendment No. 2 to Employment Agreement, dated as of September 10, 2009 by and between Richard F. Pops and Alkermes, Inc.
Exhibit 10.2 to the Alkermes, Inc. Current Report on Form 8-K (File No. 001-14131)
September 11, 2009
10.18
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. and each of Blair C. Jackson and Michael J. Landine.
Exhibit 10.3 to the Alkermes, Inc. Quarterly Report on Form 10-Q (File No. 001-14131)
February 11, 2008
10.18A
Form of Amendment to Employment Agreement with Alkermes, Inc.
Exhibit 10.7 to the Alkermes, Inc. Current Report on Form 8-K (File No. 001-14131)
October 7, 2008
10.19
Form of Covenant Not to Compete, of various dates, by and between Alkermes, Inc. and Michael J. Landine.
Exhibit 10.15(a) to the Alkermes, Inc. Annual Report on Form 10-K (File No. 001-14131)
May 30, 2008
10.20
Form of Employment Agreement entered into by and between Alkermes, Inc. and each of Iain M. Brown, David J. Gaffin, Craig C. Hopkinson, M.D. and Christian Todd Nichols.
Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 011-35299)
November 2, 2016
10.20A
Offer Letter by and between Alkermes, Inc. and Craig C. Hopkinson M.D., effective as of April 24, 2017.
Exhibit 10.17.1 to the Alkermes plc Annual Report on Form 10-K (File No. 011-35299)
February 16, 2018
77
Incorporated by reference herein
Exhibit No.
Description of Exhibit
Form
Date
10.20B
Offer Letter, dated March 29, 2019, by and between Alkermes, Inc. and Christian Todd Nichols.
Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 011-35299)
July 29, 2020
10.21
Form of Indemnification Agreement entered into by and between Alkermes, Inc. and each of the Directors and Secretaries of Alkermes plc and its Irish subsidiaries.
Exhibit 10.2 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
April 29, 2020
10.22
Form of Deed of Indemnification entered into by and between each of the Directors, Secretaries and executive officers of Alkermes plc and its subsidiaries.
Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
April 29, 2020
10.23
Alkermes plc Amended and Restated 2008 Stock Option and Incentive Plan, as amended.
Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 (File No. 001-35299)
April 27, 2017
10.23A
Form of Stock Option Award Certificate (Non-Employee Director) under the Alkermes plc Amended and Restated 2008 Stock Option and Incentive Plan, as amended.
Exhibit 10.4 to the Alkermes plc Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 (File No. 001-35299)
April 28, 2016
10.23B
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.
Exhibit 10.5 to the Alkermes plc Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 (File No. 001-35299)
April 28, 2016
10.23C
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.
Exhibit 10.6 to the Alkermes plc Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 (File No. 001-35299)
April 28, 2016
10.23D
Form of Stock Option Award Certificate (Time Vesting Non-Qualified Option – Irish) under the Alkermes plc Amended and Restated 2008 Stock Option and Incentive Plan, as amended.
Exhibit 10.7 to the Alkermes plc Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 (File No. 001-35299)
April 28, 2016
10.23E
Form Stock Option Award Certificate (Time Vesting Non-Qualified Option – U.S.) under the Alkermes plc Amended and Restated 2008 Stock Option and Incentive Plan, as amended.
Exhibit 10.8 to the Alkermes plc Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 (File No. 001-35299)
April 28, 2016
10.23F
Form of Stock Option Award Certificate (Incentive Stock Option – U.S.) under the Alkermes plc Amended and Restated 2008 Stock Option and Incentive Plan, as amended.
Exhibit 10.9 to the Alkermes plc Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 (File No. 001-35299)
April 28, 2016
10.23G
Form of 2008 Restricted Stock Unit Award Certificate (Performance Vesting Only) under the Alkermes plc Amended and Restated 2008 Stock Option and Incentive Plan, as amended.
Exhibit 10.2 to the Alkermes, Inc. Current Report on Form 8-K (File No. 001-14131)
May 22, 2009
10.24
Alkermes plc 2011 Stock Option and Incentive Plan, as amended.
Exhibit 10.1 to the Alkermes plc Current Report on Form 8-K (File No. 011-35299)
May 24, 2017
10.24A
Form of Incentive Stock Option Award Certificate under the Alkermes plc 2011 Stock Option and Incentive Plan, as amended.
Exhibit 10.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
October 23, 2018
10.24B
Form of Non-Qualified Stock Option (Employee) Award Certificate under the Alkermes plc 2011 Stock Option and Incentive Plan, as amended.
Exhibit 10.2 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
October 23, 2018
78
Incorporated by reference herein
Exhibit No.
Description of Exhibit
Form
Date
10.24C
Form of Restricted Stock Unit (Time-Vesting) Award Certificate under the Alkermes plc 2011 Stock Option and Incentive Plan, as amended.
Exhibit 10.3 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
October 23, 2018
10.24D
Form of Restricted Stock Unit (Performance-Vesting) Award Certificate under the Alkermes plc 2011 Stock Option and Incentive Plan, as amended.
Exhibit 10.4 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
October 23, 2018
10.24E
Form of Non-Qualified Stock Option (Non-Employee Director) Award Certificate under the Alkermes plc 2011 Stock Option and Incentive Plan, as amended.
Exhibit 10.5 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
October 23, 2018
10.25
Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
Exhibit 10.1 to the Alkermes plc Current Report on Form 8-K (File No. 001-35299)
July 6, 2023
10.25A
Form of Incentive Stock Option Award Certificate under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
Exhibit 10.6 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
October 23, 2018
10.25B
Form of Non-Qualified Stock Option (Employee) Award Certificate under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
Exhibit 10.7 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
October 23, 2018
10.25C
Form of Restricted Stock Unit (Time-Vesting) Award Certificate under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
Exhibit 10.8 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
October 23, 2018
10.25D
Form of Restricted Stock Unit (Performance-Vesting) Award Certificate under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
Exhibit 10.6 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
July 29, 2020
10.25E
Form of Non-Qualified Stock Option (Non-Employee Director) Award Certificate under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
Exhibit 10.4 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
July 29, 2020
10.25F
Form of Non-Employee Director Restricted Stock Unit (Time-Vesting) Award Certificate under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
Exhibit 10.5 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
July 29, 2020
10.25G
Form of Non-Employee Director New Director Grant Non-Qualified Stock Option Award Certificate under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
Exhibit 10.1.1 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
July 27, 2022
10.25H
Form of Non-Employee Director New Director Grant Restricted Stock Unit (Time-Vesting) Award Certificate under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
Exhibit 10.1.2 to the Alkermes plc Quarterly Report on Form 10-Q (File No. 001-35299)
July 27, 2022
10.25I
Form of Incentive Stock Option Award Certificate for Reporting Officers under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
Exhibit 10.19-9 to the Alkermes plc Annual Report on Form 10-K (File No. 001-35299)
February 16, 2023
10.25J
Form of Non-Qualified Stock Option Award Certificate for Reporting Officers under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
Exhibit 10.19-10 to the Alkermes plc Annual Report on Form 10-K (File No. 001-35299)
February 16, 2023
10.25K
Form of Restricted Stock Unit (Time-Vesting) Award Certificate for Reporting Officers under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
Exhibit 10.19-11 to the Alkermes plc Annual Report on Form 10-K (File No. 001-35299)
February 16, 2023
10.25L
Form of Restricted Stock Unit (Performance-Vesting) Award Certificate for Reporting Officers under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
Exhibit 10.19-12 to the Alkermes plc Annual Report on Form 10-K (File No. 001-35299)
February 16, 2023
10.25M #
Form of Restricted Stock Unit (Performance-Vesting) Award Certificate (rev. 2024) for Reporting Officers under the
79
Incorporated by reference herein
Exhibit No.
Description of Exhibit
Form
Date
Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
10.25N #
Form of Restricted Stock Unit (Performance-Vesting) Award Certificate (rev. 2024) under the Alkermes plc 2018 Stock Option and Incentive Plan, as amended.
21.1 #
List of subsidiaries.
23.1 #
Consent of PricewaterhouseCoopers LLP, an independent registered public accounting firm.
24.1 #
Power of Attorney (included on the signature pages hereto).
31.1 #
Certification Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934.
31.2 #
Certification Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934.
32.1
Certification Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
97 #
Alkermes plc Incentive Compensation Recoupment Policy.
101.SCH #
Inline XBRL Taxonomy Extension Schema with Embedded Linkbases Document.
104
Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101).
Indicates a management contract or any compensatory plan, contract or arrangement.
#
Filed herewith.
Furnished herewith.
*
Confidential treatment has been granted or requested for certain portions of this exhibit. Such portions have been filed separately with the SEC pursuant to a confidential treatment request.
**
Portions of this exhibit (indicated by “[**]”) have been omitted pursuant to Item 601(b) of Regulation S-K. The Company undertakes to furnish an unredacted copy of this exhibit upon request by the U.S. Securities and Exchange Commission.
§
Schedules and similar attachments to this exhibit have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company undertakes to furnish copies of any omitted schedules and similar attachments upon request by the U.S. Securities and Exchange Commission.
§§
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: Topic 7. Portions of this exhibit (indicated by “[**]”) have been omitted pursuant to Item 601(b) of Regulation S-K. Schedules and similar attachments to this exhibit have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company undertakes to furnish copies of any omitted schedules and similar attachments upon request by the U.S. Securities and Exchange Commission.
Item 16. Form 10-K Summary
None.
80
SIGNAT URES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ALKERMES PLC
By:
/s/ Richard F. Pops
Richard F. Pops
Chairman and Chief Executive Officer
February 21, 2024
POWER OF A TTORNEY
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
Each person whose signature appears below in so signing also makes, constitutes and appoints Richard F. Pops and Iain M. 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.
Signature
Title
Date
/s/ Richard F. Pops
Richard F. Pops
Chairman and Chief Executive Officer (Principal Executive Officer)
February 21, 2024
/s/ B lair C. Jackson
Blair C. Jackson
Executive Vice President, Chief Operating Officer (Interim Principal Financial Officer)
February 21, 2024
/s/ S amuel J. Parisi
Samuel J. Parisi
Vice President, Finance (Interim Principal Accounting Officer)
February 21, 2024
/s/ Emily Peterson Alva
Emily Peterson Alva
Director
February 21, 2024
/s/ Shane M. Cooke
Shane M. Cooke
Director
February 21, 2024
/s/ David A. Daglio, Jr.
Director
February 21, 2024
David A. Daglio, Jr.
/s/ Richard B. Gaynor
Richard B. Gaynor
Director
February 21, 2024
/s/ Cato T. Laurencin
Director
February 21, 2024
Cato T. Laurencin
/s/ Brian P. McKeon
Brian P. McKeon
Director
February 21, 2024
/s/ Nancy L. Snyderman
Nancy L. Snyderman
Director
February 21, 2024
/s/ Frank Anders Wilson
Frank Anders Wilson
Director
February 21, 2024
/s/ Christopher I. Wright
Christopher I. Wright
Director
February 21, 2024
81
Report of Independent R egistere d Public Accounting Firm
To the Board of Directors and Shareholders of Alkermes plc
Opinions on the Financial Statements and Internal Control over Financial Reporting
We have audited the accompanying consolidated balance sheets of Alkermes plc and its subsidiaries (the “Company”) as of December 31, 2023 and 2022, and the related consolidated statements of operations and comprehensive income (loss), of shareholders' equity and of cash flows for each of the three years in the period ended December 31, 2023, including the related notes (collectively referred to as the “consolidated financial statements”). We also have audited the Company's internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.
Basis for Opinions
The Company's management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in Management’s Annual Report on Internal Control over Financial Reporting appearing under Item 9A. Our responsibility is to express opinions on the Company’s consolidated financial statements and on the Company's internal control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.
Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
F- 1
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Critical Audit Matters
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. 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.
Tax-Free Determination of the Separation of the Oncology Business
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. The separation was effected by means of a distribution of shares to the Company’s shareholders. Management determined that the separation and related distribution qualified as tax-free for U.S. federal income tax purposes, which required significant judgment by management. In making such determinations, management applied U.S. federal tax law to relevant facts and circumstances and obtained: (i) a favorable private letter ruling from the IRS; (ii) a tax opinion; and (iii) other external tax advice related to the concluded tax treatment. If the separation and distribution were to fail to qualify for tax-free treatment for U.S. 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.
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.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to the key judgments in management’s evaluation of the tax treatment of the transaction. 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. 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
Rebate Accruals – Medicaid Drug Rebate Program
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. The Company records accruals for rebates to U.S. states under the Medicaid Drug Rebate Program as a reduction of sales when the product is shipped into the distribution channel using the expected value method. As of December 31, 2023, accrued Medicaid rebates were $213.8 million, of which a significant amount related to the Medicaid Drug Rebate Program. The Company rebates individual U.S. states for all eligible units purchased under the Medicaid program based on a rebate per unit calculation, which is based on the Company’s average manufacturer prices. 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.
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
F- 2
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. These procedures included testing the effectiveness of controls relating to rebate accruals for the Medicaid Drug Rebate Program, including controls over the assumptions used to estimate the rebate accruals. These procedures also included, among others, (i) developing an independent estimate of the rebate accruals by utilizing third-party data related to product sales, the historical trend of actual rebate claims paid and consideration of contractual requirement changes and market events; (ii) comparing the independent estimate to management’s estimate; and (iii) testing rebate claims processed by the Company.
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
February 21, 2024
We have served as the Company’s auditor since 2007.
F- 3
ALKERMES PLC AND SUBSIDIARIES
CONSOLIDATED B ALANCE SHEETS
December 31, 2023 and 2022
December 31, 2023
December 31, 2022
(In thousands, except share and per share amounts)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
457,469
$
292,473
Receivables, net
332,477
287,967
Investments—short-term
316,022
315,992
Inventory
186,406
181,418
Contract assets
706
8,929
Prepaid expenses and other current assets
98,166
41,203
Assets related to discontinued operations
—
2,324
Assets held for sale
94,260
—
Total current assets
1,485,506
1,130,306
PROPERTY, PLANT AND EQUIPMENT, NET
226,943
222,919
INVESTMENTS—LONG-TERM
39,887
131,610
RIGHT-OF-USE ASSETS
91,460
97,539
ASSETS RELATED TO DISCONTINUED OPERATIONS—LONG-TERM
—
37,763
ASSETS HELD FOR SALE—LONG-TERM
—
93,871
INTANGIBLE ASSETS, NET
1,991
37,680
GOODWILL
83,027
83,027
DEFERRED TAX ASSETS
195,888
114,572
OTHER ASSETS
11,521
14,691
TOTAL ASSETS
$
2,136,223
$
1,963,978
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses
$
240,561
$
220,089
Accrued sales discounts, allowances and reserves
263,641
252,115
Operating lease liabilities—short-term
5,746
9,878
Contract liabilities—short-term
2,730
6,816
Current portion of long-term debt
3,000
3,000
Liabilities related to discontinued operations
4,542
5,844
Total current liabilities
520,220
497,742
LONG-TERM DEBT
287,730
290,270
OPERATING LEASE LIABILITIES—LONG-TERM
75,709
76,287
LIABILITIES RELATED TO DISCONTINUED OPERATIONS—LONG-TERM
—
13,542
OTHER LONG-TERM LIABILITIES
49,878
42,384
Total liabilities
933,537
920,225
COMMITMENTS AND CONTINGENT LIABILITIES (Note 19)
SHAREHOLDERS’ EQUITY:
Preferred shares, par value, $ 0.01 per share; 50,000,000 shares authorized; zero issued and outstanding at December 31, 2023 and 2022, respectively
—
—
Ordinary shares, par value, $ 0.01 per share; 450,000,000 shares authorized; 172,569,051 and 168,951,193 shares issued; 166,979,833 and 164,377,009 shares outstanding at December 31, 2023 and 2022, respectively
1,726
1,690
Treasury shares, at cost ( 5,589,218 and 4,574,184 shares at December 31, 2023 and 2022, respectively)
( 189,336
)
( 160,862
)
Additional paid-in capital
2,736,934
2,913,099
Accumulated other comprehensive loss
( 3,110
)
( 10,889
)
Accumulated deficit
( 1,343,528
)
( 1,699,285
)
Total shareholders’ equity
1,202,686
1,043,753
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$
2,136,223
$
1,963,978
The accompanying notes are an integral part of these consolidated financial statements.
F- 4
ALKERMES PLC AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPE RATIONS AND COMPREHENSIVE INCOME (LOSS)
Years Ended December 31, 2023, 2022 and 2021
Year Ended December 31,
2023
2022
2021
(In thousands, except per share amounts)
REVENUES:
Product sales, net
$
919,998
$
777,552
$
627,424
Manufacturing and royalty revenues
743,388
331,983
541,807
License revenue
—
2,000
3,500
Research and development revenue
19
260
1,020
Total revenues
1,663,405
1,111,795
1,173,751
EXPENSES:
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below)
253,037
218,068
197,323
Research and development
270,806
272,702
290,924
Selling, general and administrative
689,751
590,751
549,610
Amortization of acquired intangible assets
35,689
36,363
38,148
Total expenses
1,249,283
1,117,884
1,076,005
OPERATING INCOME (LOSS)
414,122
( 6,089
)
97,746
OTHER INCOME (EXPENSE), NET:
Interest income
30,854
7,629
2,408
Interest expense
( 23,032
)
( 13,040
)
( 11,219
)
Change in the fair value of contingent consideration
—
( 21,750
)
( 1,427
)
Other (expense) income, net
( 425
)
2,122
219
Total other income (expense), net
7,397
( 25,039
)
( 10,019
)
INCOME (LOSS) BEFORE INCOME TAXES
421,519
( 31,128
)
87,727
INCOME TAX (BENEFIT) PROVISION
( 97,638
)
2,024
11,326
NET INCOME (LOSS) FROM CONTINUING OPERATIONS
519,157
( 33,152
)
76,401
DISCONTINUED OPERATIONS, NET OF TAX
( 163,400
)
( 125,115
)
( 124,570
)
NET INCOME (LOSS)
$
355,757
$
( 158,267
)
$
( 48,169
)
EARNINGS (LOSS) PER ORDINARY SHARE:
Earnings (loss) per share from continuing operations - basic
$
3.12
$
( 0.20
)
$
0.47
Earnings (loss) per share from discontinued operations - basic
$
( 0.98
)
$
( 0.76
)
$
( 0.77
)
Earnings (loss) per share - basic
$
2.14
$
( 0.97
)
$
( 0.30
)
Earnings (loss) per share from continuing operations - diluted
$
3.06
$
( 0.20
)
$
0.46
Earnings (loss) per share from discontinued operations - diluted
$
( 0.96
)
$
( 0.76
)
$
( 0.76
)
Earnings (loss) per share - diluted
$
2.10
$
( 0.97
)
$
( 0.29
)
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING:
Basic
166,223
163,742
160,942
Diluted
169,730
163,742
164,753
COMPREHENSIVE INCOME (LOSS):
Net income (loss)
$
355,757
$
( 158,267
)
$
( 48,169
)
Holding gain (loss), net of a tax provision (benefit) of $ 1,195 , $( 973 ) and $( 706 ), respectively
7,779
( 7,166
)
( 2,374
)
COMPREHENSIVE INCOME (LOSS)
$
363,536
$
( 165,433
)
$
( 50,543
)
The accompanying notes are an integral part of these consolidated financial statements.
F- 5
ALKERMES PLC AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
Years Ended December 31, 2023, 2022 and 2021
Accumulated
Additional
Other
Ordinary Shares
Paid-In
Comprehensive
Accumulated
Treasury Stock
Shares
Amount
Capital
Loss
Deficit
Shares
Amount
Total
(In thousands, except share data)
BALANCE — December 31, 2020
162,269,220
$
1,620
$
2,685,647
$
( 1,349
)
$
( 1,492,849
)
( 3,108,079
)
$
( 126,087
)
$
1,066,982
Issuance of ordinary shares under employee stock plans
3,521,329
38
25,281
—
—
—
—
25,319
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards
—
—
—
—
—
( 745,143
)
( 16,571
)
( 16,571
)
Share-based compensation
—
—
87,397
—
—
—
—
87,397
Unrealized loss on marketable securities, net of tax benefit of $ 706
—
—
—
( 2,374
)
—
—
—
( 2,374
)
Net loss
—
—
—
—
( 48,169
)
—
—
( 48,169
)
BALANCE — December 31, 2021
165,790,549
$
1,658
$
2,798,325
$
( 3,723
)
$
( 1,541,018
)
( 3,853,222
)
$
( 142,658
)
$
1,112,584
Issuance of ordinary shares under employee stock plans
3,160,644
32
19,598
—
—
—
—
19,630
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards
—
—
—
—
—
( 720,962
)
( 18,204
)
( 18,204
)
Share-based compensation
—
—
95,176
—
—
—
—
95,176
Unrealized loss on marketable securities, net of tax benefit of $ 973
—
—
—
( 7,166
)
—
—
—
( 7,166
)
Net loss
—
—
—
—
( 158,267
)
—
—
( 158,267
)
BALANCE —December 31, 2022
168,951,193
$
1,690
$
2,913,099
$
( 10,889
)
$
( 1,699,285
)
( 4,574,184
)
$
( 160,862
)
$
1,043,753
Issuance of ordinary shares under employee stock plans
3,617,858
36
16,724
—
—
—
—
16,760
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards
—
—
—
—
—
( 1,015,034
)
( 28,474
)
( 28,474
)
Share-based compensation
—
—
100,871
—
—
—
—
100,871
Unrealized gain on marketable securities, net of tax provision of $ 1,195
—
—
—
7,779
—
—
—
7,779
Distribution of Mural Oncology plc
—
—
( 293,760
)
—
—
—
—
( 293,760
)
Net income
—
—
—
—
355,757
—
—
355,757
BALANCE —December 31, 2023
172,569,051
$
1,726
$
2,736,934
$
( 3,110
)
$
( 1,343,528
)
( 5,589,218
)
$
( 189,336
)
$
1,202,686
The accompanying notes are an integral part of these consolidated financial statements.
F- 6
ALKERMES PLC AND SUBSIDIARIES
CONSOLIDATED STATEM ENTS OF CASH FLOWS
Years Ended December 31, 2023, 2022 and 2021
Year Ended December 31,
2023
2022
2021
(In thousands)
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)
$
355,757
$
( 158,267
)
$
( 48,169
)
Adjustments to reconcile net income (loss) to cash flows from operating activities:
Depreciation and amortization
74,927
77,862
78,652
Share-based compensation expense
100,905
94,254
87,622
Deferred income taxes
( 99,902
)
( 32,795
)
5,081
Change in the fair value of contingent consideration
—
21,750
1,427
Other non-cash charges
6,329
5,531
2,650
Changes in assets and liabilities:
Receivables
( 44,510
)
25,250
( 38,011
)
Contract assets
8,223
4,434
6,037
Inventory
( 2,712
)
( 31,021
)
( 24,769
)
Prepaid expenses and other assets
( 34,847
)
( 5,328
)
11,481
Right-of-use assets
15,387
16,569
17,051
Accounts payable and accrued expenses
23,009
15,534
11,514
Accrued sales discounts, allowances and reserves
11,526
14,899
18,339
Contract liabilities
( 5,926
)
( 7,129
)
( 6,080
)
Operating lease liabilities
( 16,147
)
( 33,225
)
( 16,777
)
Other long-term liabilities
9,334
12,726
( 4,333
)
Cash flows provided by operating activities
401,353
21,044
101,715
CASH FLOWS FROM INVESTING ACTIVITIES:
Additions of property, plant and equipment
( 48,048
)
( 38,255
)
( 28,020
)
Proceeds from the sale of equipment
354
—
287
Proceeds from contingent consideration
—
1,273
7,937
Return of Fountain Healthcare Partners II, L.P. investment
—
485
—
Payment made for licensed Intellectual Property ("IP")
—
—
( 1,000
)
Purchases of investments
( 254,471
)
( 309,671
)
( 340,418
)
Sales and maturities of investments
355,522
281,627
295,010
Cash flows provided by (used in) investing activities
53,357
( 64,541
)
( 66,204
)
CASH FLOWS FROM FINANCING ACTIVITIES:
Cash transferred to Mural Oncology plc at separation
( 275,000
)
—
—
Proceeds from the issuance of ordinary shares under share-based compensation arrangements
16,760
19,630
25,319
Employee taxes paid related to net share settlement of equity awards
( 28,474
)
( 18,204
)
( 16,571
)
Proceeds from the issuance of long-term debt
—
—
23,567
Payment made for debt extinguishment
—
—
( 993
)
Principal payments of long-term debt
( 3,000
)
( 3,000
)
( 2,250
)
Cash flows (used in) provided by financing activities
( 289,714
)
( 1,574
)
29,072
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
164,996
( 45,071
)
64,583
CASH AND CASH EQUIVALENTS—Beginning of period
292,473
337,544
272,961
CASH AND CASH EQUIVALENTS—End of period
$
457,469
$
292,473
$
337,544
SUPPLEMENTAL CASH FLOW DISCLOSURE:
Cash paid for interest
$
22,748
$
13,563
$
6,904
Cash paid for taxes
$
44,243
$
20,749
$
1,888
Non-cash investing and financing activities:
Purchased capital expenditures included in accounts payable and accrued expenses
$
2,645
$
2,950
$
6,025
The accompanying notes are an integral part of these consolidated financial statements.
F- 7
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
Alkermes plc (the “Company”) is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. 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. Headquartered in Dublin, Ireland, the Company has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
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”). 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”). The historical results of the oncology business have been reflected as discontinued operations in the Company’s consolidated financial statements through November 15, 2023 (the “Separation Date”). For additional information related to the Separation, see Note 3, Discontinued Operations in these “Notes to Consolidated Financial Statements” in this Annual Report.
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. Such transaction is expected to close in mid-2024, subject to certain closing conditions. 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.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Principles of Consolidation
The consolidated financial statements include the accounts of Alkermes plc and its wholly-owned subsidiaries. Intercompany accounts and transactions have been eliminated. Columns and rows within tables may not sum due to rounding.
Reclassification
The Company has presented its former oncology business as discontinued operations in its consolidated financial statements for all periods presented. See Note 3, Discontinued Operations in these “Notes to Consolidated Financial Statements” in this Annual Report for additional information. 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. The Company’s historical financial statements and footnotes have been recast accordingly.
Discontinued Operations
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 . 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).
Assets Held for Sale
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. 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.
F- 8
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Use of Estimates
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. 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. 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. Actual results may differ from these estimates under different assumptions or conditions.
Cash and Cash Equivalents
The Company values its cash and cash equivalents at cost plus accrued interest, which the Company believes approximates their market value. 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.
Investments
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. agencies and backed by non-U.S. governments. The Company generally 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. At December 31, 2023, substantially all these investments were classified as available-for-sale and were recorded at fair value.
Unrealized gains and losses are included in accumulated other comprehensive loss in equity, net of related tax, unless: (i) the security has experienced a credit loss; (ii) the Company has determined that it has the intent to sell the security; or (iii) the Company has determined that it is more likely than not that it will have to sell the security before its expected recovery. Periodic reviews are conducted to identify and evaluate each investment that has an unrealized loss in accordance with the meaning of other-than-temporary impairment. An unrealized loss exists when the current fair value of an individual security is less than its amortized cost basis.
For available-for-sale debt securities with unrealized losses, the Company performs an analysis to assess whether it intends to sell, or whether it would more likely than not be required to sell, the security before the expected recovery of the amortized cost basis. Where the Company intends to sell a security, or may be required to do so, the security’s decline in fair value is deemed to be other-than-temporary and the full amount of the unrealized loss is reflected in earnings as an impairment loss.
Regardless of the Company’s intent to sell a security, the Company performs additional analysis on all securities with unrealized losses to evaluate losses associated with the creditworthiness of the security. Credit losses are identified where the Company does not expect to receive cash flows sufficient to recover the amortized cost basis of a security.
The Company’s held-to-maturity investments are restricted investments held as collateral under letters of credit related to certain of the Company’s agreements and are included in “Investments—long-term,” in the accompanying consolidated balance sheets.
Fair Value of Financial Instruments
The Company’s financial assets and liabilities are recorded at fair value and are classified as Level 1, 2 or 3 within the fair value hierarchy, as described in the accounting standards for fair value measurement. At December 31, 2023, the Company’s financial assets consisted of cash equivalents and investments and are classified within the fair value hierarchy as follows:
• Level 1 –these valuations are based on a market approach using quoted prices in active markets for identical assets. Valuations of these products do not require a significant degree of judgment. Assets utilizing Level 1 inputs at December 31, 2023 included U.S. treasury securities, marketable securities classified as cash equivalents and a fixed term deposit account; and
• Level 2 –these valuations are based on quoted prices for identical or similar assets in active markets or other market observable inputs such as interest rates, yield curves, foreign currency spot rates and option pricing valuation models. Assets utilizing Level 2 inputs at December 31, 2023 included U.S. government agency debt securities, debt securities issued by non-U.S. agencies and backed by non-U.S. governments and investments in corporate debt securities that are trading in the credit markets.
F- 9
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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.
Inventory
Inventory is stated at the lower of cost and net realizable value. Cost is determined using the first-in, first-out method. Included in inventory are raw materials used in production of preclinical and clinical products, which have alternative future use and are charged to R&D expense when consumed. The cost elements included within inventory include three primary categories for commercial products: cost of raw materials; direct labor; and overhead. 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).
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. The Company assesses the regulatory approval process and where the particular product stands in relation to that approval process, including any known safety, efficacy or quality concerns, potential labeling restrictions and other potential impediments to approval. The Company also considers the shelf life of the product in relation to the expected timeline for approval and considers issues that may prevent or delay commercialization, including issues that may arise in relation to the manufacturing of the product. The Company expenses previously capitalized costs related to pre-approval inventory upon a change in such judgment, due to, among other potential factors, a denial or significant delay of approval by relevant regulatory agencies or other issues that may make the pre-approval inventory batches less likely or unlikely to be commercialized and to result in future economic benefit.
Property, Plant and Equipment
Property, plant and equipment are recorded at cost, subject to review for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. Expenditures for repairs and maintenance are charged to expense as incurred and major renewals and improvements are capitalized. Depreciation is calculated using the straight-line method over the following estimated useful lives of the assets:
Asset group
Term
Buildings and improvements
15 - 40 years
Furniture, fixtures and equipment
3 - 10 years
Leasehold improvements
Shorter of useful life or lease term
Goodwill and Intangible Assets
Goodwill represents the excess cost of the Company’s investment in the net assets of acquired companies over the fair value of the underlying identifiable net assets at the date of acquisition. The Company’s goodwill consists solely of goodwill created as a result of the Company’s acquisition of Elan Drug Technologies (“EDT”) from Elan Corporation, plc (such acquisition, the “Business Combination”) in September 2011 and has been assigned to one reporting unit. A reporting unit is an operating segment or one level below an operating segment or a component to which goodwill is assigned when initially recorded.
Goodwill is not amortized but is reviewed for impairment on an annual basis, as of October 31, and whenever events or changes in circumstances indicate that the carrying value of the goodwill might not be recoverable. The Company has the option to first assess qualitative factors to determine whether it is necessary to perform the quantitative impairment test. If the Company elects this option and believes, as a result of the qualitative assessment, that it is more-likely-than-not that the fair value of its reporting unit is less than its carrying amount, the quantitative impairment test is required; otherwise, no further testing is required. Alternatively, the Company may elect to not first assess qualitative factors and immediately perform the quantitative impairment test. In the quantitative impairment test, the Company compares the fair value of its reporting unit to its carrying value. If the carrying value of the net assets assigned to the reporting unit exceeds the fair value of the reporting unit, then the Company would record an impairment loss equal to the difference.
When some, but not all, of a reporting unit is to be disposed of, the accounting for that reporting unit’s goodwill will depend on whether the disposal group constitutes a business. If the disposal group constitutes a business, the Company attributes a portion of the reporting unit’s goodwill to the disposal group based on the relative fair values of: (i) the disposal group; and (ii) the portion of the reporting unit that will be retained.
F- 10
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Company’s finite-lived intangible assets, consisting of core developed technology and collaboration agreements acquired as part of the Business Combination, were recorded at fair value at the time of their acquisition and are stated within the Company’s consolidated balance sheets net of accumulated amortization. The finite-lived intangible assets are amortized over their estimated useful lives using the economic use method, which reflects the pattern that the economic benefits of the intangible assets are consumed as revenue is generated from the underlying patent or contract. The useful lives of the Company’s intangible assets are primarily based on the legal or contractual life of the underlying patent or contract, which does not include additional years for the potential extension or renewal of the contract or patent.
Impairment of Long-Lived Assets
The Company reviews long-lived assets to be held and used for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. Conditions that would necessitate an impairment assessment include a significant decline in the observable market value of an asset; a significant change in the extent or manner in which an asset is used; a significant adverse change in legal factors or in the business climate that could affect the value of a long-lived asset; an accumulation of costs significantly in excess of the amount originally expected for the acquisition or construction of a long-lived asset; a current-period operating or cash flow loss combined with a history of operating or cash-flow losses or a projection or forecast that demonstrates continuing losses associated with the use of a long-lived asset; or a current expectation that, more likely than not, a long-lived asset will be sold or otherwise disposed of significantly before the end of its previously estimated useful life. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their estimated fair values. Long-lived assets to be disposed of are carried at fair value less costs to sell them.
Revenue from Contracts with Customers
The Company recognizes revenue in accordance with FASB ASC 606, Revenue from Contracts with Customers (“Topic 606”). 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. 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. 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.
The Company recognizes revenue when or as it satisfies a performance obligation by transferring an asset or providing a service to a customer. 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. 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.
Product Sales, Net
The Company’s product sales, net consist of sales in the U.S. of VIVITROL ® , ARISTADA ® and 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.
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, healthcare providers or payers. The Company’s process for estimating reserves established for these variable consideration components does not differ materially from historical practices. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from the Company’s estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment. The following are the Company’s significant categories of sales discounts and allowances:
• Medicaid Rebates —the Company records accruals for rebates to U.S. states under the Medicaid Drug Rebate Program as a reduction of sales when the product is shipped into the distribution channel using the expected value method. The Company rebates individual U.S. states for all eligible units purchased under the Medicaid program based on a rebate per unit calculation, which is based on the Company’s average manufacturer prices. 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. To date, actual Medicaid rebates have not differed materially from the Company’s estimates;
F- 11
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
• Chargebacks —discounts that occur when contracted indirect customers purchase directly from wholesalers and specialty distributors. Contracted customers generally purchase a product at its contracted price. The wholesaler or specialty distributor, in turn, then generally charges back to the Company the difference between the wholesale acquisition cost and the contracted price paid to the wholesaler or specialty distributor by the customer. The allowance for chargebacks is made using the expected value method and is based on actual and expected utilization of these programs. Chargebacks could exceed historical experience and the Company’s estimates of future participation in these programs. To date, actual chargebacks have not differed materially from the Company’s estimates;
• 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. The reserve is made using the expected value method and to date, actual product discounts have not differed materially from the Company’s estimates;
• Product Returns —the Company records an estimate for product returns at the time its customers take control of their product. The Company estimates this liability using the expected returns of product sold based on historical return levels and specifically identified anticipated returns due to known business conditions and product expiry dates. Return amounts are recorded as a reduction of sales. Once product is returned, it is destroyed. To date, actual product returns have not differed materially from the Company’s estimates; and
• Medicare Part D —the Company records accruals for Medicare Part D liabilities under the Medicare Coverage Gap Discount Program (“CGDP”) as a reduction of sales. Under the CGDP, patients reaching the annual coverage gap threshold are eligible for reimbursement coverage for out-of-pocket costs for covered prescription drugs. Under an agreement with the Centers for Medicare and Medicaid Services, manufacturers are responsible to reimburse prescription plan sponsors for the portion of out-of-pocket expenses not covered under their Medicare plans. To date, actual Medicare Part D rebates have not differed materially from the Company’s estimates.
Collaborative Arrangements
The Company has entered into collaborative arrangements with pharmaceutical companies including, among others, Janssen Pharmaceuticals, Inc. (“Janssen, Inc.”), Janssen Pharmaceutica International, a division of Cilag International AG (“Janssen International”), and Janssen Pharmaceutica N.V. (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 ® . 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.
Manufacturing Revenue
The Company recognizes manufacturing revenues from the sale of products it manufactures for resale by its licensees. Substantially all of the manufacturing revenues are recognized at a point in time when control of the product passes to the licensee. The sales price for certain of the Company’s manufacturing revenues is based on the end-market sales price earned by its licensees. As end-market sales generally occur after the Company has recorded manufacturing revenue, the Company estimates the sales price for such products based on information supplied to it by the Company’s licensees, its historical transaction experience and other third-party data. Differences between actual manufacturing revenues and estimated manufacturing revenues are reconciled and adjusted for in the period in which they become known, which is generally within the same quarter. The differences between the Company’s actual and estimated manufacturing revenues have not been material to date.
Royalty Revenue
The Company recognizes royalty revenues related to the sale by its licensees of products that incorporate the Company’s technologies. All of the Company’s royalties qualify for the sales-and-usage exemption under Topic 606 as (i) such royalties are based strictly on the sales-and-usage by the licensee; and (ii) a license of IP is the sole or predominant item to which such royalties relate. Based on this exemption, these royalties are earned in the period that the products are sold by the Company’s licensee and the Company has a present right to payment.
Certain of the Company’s royalty revenues are recognized by the Company based on information supplied to the Company by its licensees and require estimates to be made. Differences between actual royalty revenues and estimated royalty revenues are reconciled and adjusted for in the period in which they become known, which is generally within the same quarter. The differences between the Company’s actual and estimated royalty revenues have not been material to date.
F- 12
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
License Revenue
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
Receivables, net, include amounts billed and amounts unbilled but currently unconditionally due from customers. The amounts due are stated at their net estimated realizable value. The Company’s unbilled receivable balance was $ 103.1 million and $ 72.0 million at December 31, 2023 and 2022, respectively, and related primarily to royalty revenue. The Company maintains an allowance for doubtful accounts to provide for the estimated amounts of receivables that will not be collected. The allowance is based upon an assessment of customer creditworthiness, historical payment experience, the age of outstanding receivables and collateral to the extent applicable. The Company’s allowance for doubtful accounts was approximately $ 0.2 million at each of December 31, 2023 and 2022.
Contract Assets
Contract assets include unbilled amounts that will result in a sale under certain of the Company’s manufacturing contracts. 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 .
Contract assets consisted of the following:
(In thousands)
Contract Assets
Contract assets at January 1, 2022
$
13,363
Additions
42,218
Transferred to receivables, net
( 46,652
)
Contract assets at December 31, 2022
$
8,929
Additions
13,606
Transferred to receivables, net
( 21,829
)
Contract assets at December 31, 2023
$
706
Contract Liabilities
Contract liabilities consist of contractual obligations related to deferred revenue. 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.
Contract liabilities consisted of the following:
(In thousands)
Contract Liabilities
Contract liabilities at January 1, 2022
$
17,830
Additions
6,769
Amounts recognized into revenue
( 7,514
)
Amounts recognized into other (expense) income, net
( 6,384
)
Contract liabilities at December 31, 2022
$
10,701
Reductions
( 931
)
Amounts recognized into revenue
( 4,995
)
Contract liabilities at December 31, 2023
$
4,775
Foreign Currency
The Company’s functional and reporting currency is the U.S. dollar. Transactions in foreign currencies are recorded at the exchange rate prevailing on the date of the transaction. The resulting monetary assets and liabilities are translated into U.S. dollars at exchange rates prevailing on the subsequent balance sheet date. 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). 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.
F- 13
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Concentrations
Financial instruments that potentially subject the Company to concentrations of credit risk are receivables and marketable securities. 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. To mitigate credit risk, the Company monitors the financial performance and credit-worthiness of its customers. The following represents revenue and receivables from the Company’s customers exceeding 10 % of the total in each category as of, and for the years ended, December 31, 2023, 2022 and 2021:
Year Ended December 31,
2023
2022
2021
Customer
Receivables
Revenue
Receivables
Revenue
Receivables
Revenue
Janssen
23
%
31
%
*
15
%
30
%
30
%
Biogen
9
%
11
%
19
%
13
%
11
%
10
%
Cardinal Health
24
%
20
%
24
%
24
%
17
%
20
%
AmerisourceBergen
16
%
12
%
18
%
14
%
13
%
11
%
McKesson
14
%
14
%
12
%
16
%
11
%
13
%
*
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, 2023, 2022 and 2021, as noted.
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. The Company’s investment objectives are, first, to ensure liquidity and conservation of capital and, second, to obtain investment income.
Geographic Information
Company revenues by geographic location for the years ended December 31, 2023, 2022 and 2021, as determined by the location of the customer, are as follows:
Year Ended December 31,
(In thousands)
2023
2022
2021
Revenue by region:
U.S.
$
1,491,939
$
931,991
$
984,235
Ireland
1,179
1,829
2,175
Rest of world
170,287
177,975
187,341
The location of the Company’s assets are as follows:
December 31,
(In thousands)
2023
2022 (1)
Assets by region:
Current assets:
U.S.:
Assets related to discontinued operations
$
—
$
2,324
Other current assets
867,588
700,240
Ireland:
Assets held for sale
$
94,260
$
—
Other current assets
523,658
427,742
Rest of world
—
—
Long-term assets:
U.S.:
Assets related to discontinued operations
$
—
$
37,763
Other
432,870
499,038
Ireland:
Intangible assets
$
1,991
$
37,680
Assets held for sale
—
93,871
Goodwill
83,027
83,027
Other
132,829
82,293
(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.
F- 14
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Research and Development Expenses
For each of its R&D programs, the Company incurs both external and internal expenses. External R&D expenses include fees related to clinical and preclinical activities performed by contract research organizations, consulting fees and costs related to laboratory services, purchases of drug product materials and third-party manufacturing development costs. Internal R&D expenses include employee-related expenses, occupancy costs, depreciation and general overhead. The Company tracks external R&D expenses for each of its development programs, however, internal R&D expenses are not tracked by individual program as they benefit multiple development programs or the Company’s products or technologies in general.
Selling, General and Administrative Expenses
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.
Advertising costs are expensed as incurred. During the years ended December 31, 2023, 2022 and 2021, advertising costs totaled $ 127.6 million, $ 41.4 million and $ 38.9 million, respectively.
Share-Based Compensation
The Company’s share-based compensation programs permit grants of awards in the form of stock options and restricted stock unit awards (“RSUs”), which vest with the passage of time and/or based on the achievement of certain performance criteria. The Company issues new shares upon the exercise of stock options or the vesting of RSUs. Under the terms of the Company’s stock option and incentive plans (the “Plans”), the Company’s employees may, at the discretion of the plan administrator, become eligible in certain circumstances set forth in the Plans for accelerated vesting of certain awards granted to them under the Plans. In such circumstances, if there are no effective future service requirements for such employees, the remaining fair value of any such accelerated awards would be expensed as of the date of acceleration.
Time-Based Stock Options
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. Except as otherwise provided in the applicable Plan: (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; 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. The estimated fair value of options is recognized over the requisite service period, which is generally the vesting period. Share-based compensation expense is based on awards ultimately expected to vest. Forfeitures are estimated based on historical experience at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates.
The fair value of stock option grants is based on estimates as of the date of grant using a Black-Scholes option valuation model. The Company uses historical data as the basis for estimating stock option terms and forfeitures. Separate groups of employees that have similar historical stock option exercise and forfeiture behavior are considered separately for valuation purposes. The ranges of expected terms disclosed below reflect different expected behavior among certain groups of employees. Expected stock volatility factors are based on a weighted average of implied volatilities from traded options of the Company’s ordinary shares and historical share price volatility of the Company’s ordinary shares, which is determined based on a review of the weighted average of historical weekly price changes of the Company’s ordinary shares. The risk-free interest rate for periods commensurate with the expected term of the stock option is based on the U.S. treasury yield curve in effect at the time of grant. The dividend yield on the Company’s ordinary shares is estimated to be zero as the Company has not paid dividends and does not expect to pay dividends in the near future. The exercise price of options granted is equal to the closing price of the Company’s ordinary shares traded on the Nasdaq Global Select Market on the date of grant.
The fair value of each stock option granted was estimated on the grant date with the following weighted-average assumptions:
Year Ended December 31,
2023
2022
2021
Expected option term
5 - 8 years
5 - 8 years
5 - 7 years
Expected stock volatility
40 % - 44 %
43 % - 51 %
43 % - 54 %
Risk-free interest rate
3.34 % - 4.75 %
1.83 % - 4.26 %
0.67 % - 1.46 %
Expected annual dividend yield
—
—
—
F- 15
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Time-Based Restricted Stock Unit Awards
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. Shares subject to these RSUs are delivered to the employee upon vesting, subject to payment of applicable withholding taxes. The fair value of time-based RSUs is equal to the closing price of the Company’s ordinary shares traded on the Nasdaq Global Select Market on the date of grant. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period.
Performance-Based Restricted Stock Unit Awards
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. 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. In that case, the fair value of the 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.
Conversion and modification of equity awards outstanding at Separation date
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. 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”).
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. Following this calculation, it was determined that no incremental fair value resulted from the application of the Alkermes Conversion Ratio.
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. 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. 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.
Income Taxes
The Company recognizes income taxes under the asset and liability method. Deferred income taxes are recognized for differences between the financial reporting and tax bases of assets and liabilities at enacted statutory tax rates in effect for the years in which the differences are expected to reverse. The effect on deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date. In evaluating the Company’s ability to recover its deferred tax assets, the Company considers all available positive and negative evidence including its past operating results, the existence of cumulative income in the most recent fiscal years, changes in the business in which the Company operates and its forecast of future taxable income. In determining future taxable income, the Company is responsible for assumptions utilized including the amount of Irish and non-Irish pre-tax operating income, the reversal of temporary differences and the implementation of feasible and prudent tax planning strategies. 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.
F- 16
ALKERMES PLC AND SUBSIDIARIES
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. The evaluation of uncertain tax positions is based on factors including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related to a tax position. The Company evaluates its tax position on a quarterly basis. The Company also accrues for potential interest and penalties related to unrecognized tax benefits in income tax expense.
Comprehensive Income (Loss)
Comprehensive income (loss) consists of net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) includes changes in equity that are excluded from net income (loss), such as unrealized holding gains and losses on available-for-sale investments.
Earnings (Loss) Per Share
Basic earnings (loss) per ordinary share from continuing operations is calculated based upon net income (loss) from continuing operations available to holders of ordinary shares divided by the weighted average number of ordinary shares outstanding. Basic loss per ordinary share from discontinued operations is calculated based upon net loss from discontinued operations available to holders of ordinary shares, divided by the weighted average number of ordinary shares outstanding. For the calculation of diluted earnings (loss) per ordinary share from continuing operations and discontinuing operations, the Company utilizes the treasury stock method and adjusts the weighted average number of ordinary shares outstanding for the potential dilutive effect of outstanding ordinary share equivalents such as stock options and RSUs.
Segment Information
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. 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.
Employee Benefit Plans
401(k) Plan
The Company maintains a 401(k) retirement savings plan (the “401(k) Plan”), which covers substantially all of its U.S.-based employees. Eligible employees may contribute up to 100 % of their eligible compensation, subject to certain Internal Revenue Service (“IRS”) limitations. The Company matches 100 % of employee contributions up to the first 5 % of employee pay, up to IRS limits. Employee and Company contributions are fully vested when made. During the years ended December 31, 2023, 2022 and 2021, the Company contributed $ 15.0 million, $ 14.4 million and $ 13.7 million, respectively, to match employee deferrals under the 401(k) Plan.
Defined Contribution Plan
The Company maintains a defined contribution plan for its Ireland-based employees (the “Defined Contribution Plan”). The Defined Contribution Plan provides for eligible employees to contribute up to a maximum of 40 %, depending upon their age, of their total taxable earnings subject to an earnings cap of € 115,000 . The Company provides a match of up to 18 % of taxable earnings depending upon an individual’s contribution level. During the years ended December 31, 2023, 2022 and 2021, the Company contributed $ 5.6 million, $ 5.1 million and $ 5.2 million, respectively, in contributions to the Defined Contribution Plan.
New Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard-setting bodies that are adopted by the Company as of the specified effective date. 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.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): 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. The amendments in this guidance also expand the interim segment disclosure requirements. All disclosure requirements under this guidance are required for public entities with a single reportable segment. This ASU became effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the amendments in this guidance are required to be applied on a retrospective basis. The Company is currently evaluating the potential impact this ASU will have on its consolidated financial statements and related disclosures.
F- 17
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to enhance the transparency and decision usefulness of income tax disclosures in order to provide information to assist key stakeholders in better assessing how the Company’s operations and related tax risks and tax planning and operational opportunities affect the Company’s tax rate and prospects for future cash flows. This ASU becomes effective for public companies for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. This guidance will be applied on a prospective basis. The Company is currently evaluating the impact this ASU will have on its consolidated financial statements and related disclosures.
3. DISCONTINUED OPERATIONS
Mural Oncology Separation
On November 15, 2023, the Company completed the Separation. 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. 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.
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.
The transfer of assets and liabilities to Mural was effected through a contribution in accordance with the separation agreement, as summarized below:
(In thousands)
November 15, 2023
ASSETS
Current Assets:
Cash and cash equivalents
$
275,000
Total current assets
275,000
Property, plant and equipment, net
10,096
Right-of-use assets
14,513
Goodwill
7,800
Deferred tax asset
1,799
Total assets
$
309,208
LIABILITIES
Current Liabilities
Operating lease liabilities—short-term
$
6,036
Total current liabilities
6,036
Operating lease liabilities—long-term
9,412
Total liabilities
15,448
Net assets transferred to Mural
$
293,760
The Company determined that the Separation and related Distribution qualified as tax-free for U.S. federal income tax purposes, which required significant judgment by management. In making such determinations, the Company applied U.S. federal tax law to
F- 18
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
relevant facts and circumstances and obtained: (i) a favorable private letter ruling from the IRS; (ii) a tax opinion; and (iii) other external tax advice related to the concluded tax treatment. If the Separation and Distribution were to ultimately fail to qualify for tax-free treatment for U.S. 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. Furthermore, other than taxes recorded on the transfer of intellectual property, the Company determined that the Separation and related Distribution qualified as tax-free for Irish tax purposes, which required significant judgment by management. In making such determinations, the Company applied Irish tax law to relevant facts and circumstances and obtained: (i) a tax opinion; and (ii) other external tax advice related to the concluded tax treatment. If the Separation and Distribution were to ultimately fail to qualify for tax-free treatment for Irish 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.
In connection with the Separation, the Company also entered into a tax matters agreement with Mural, dated as of November 13, 2023 . The tax matters agreement governs the Company’s and Mural’s respective rights, responsibilities and obligations with respect to taxes (including taxes arising in the ordinary course of business and taxes, if any, incurred as a result of any failure of the Distribution, together with certain related transactions, to qualify as tax-free for U.S. federal income tax purposes), tax attributes, the preparation and filing of tax returns, the control of audits and other tax proceedings, and assistance and cooperation in respect of tax matters.
In connection with the Separation, the Company also entered into the Employee Matters Agreement. The Employee Matters Agreement, as amended, governs the Company’s, Mural’s and their respective subsidiaries’ and affiliates’ rights, responsibilities and obligations after the Separation with respect to, employment, benefits and compensation matters relating to employees and former employees (and their respective dependents and beneficiaries) who are or were associated with the Company, including those who became employees of Mural in connection with the Separation; the allocation of assets and liabilities generally relating to employees, employment or service-related matters and employee benefit plans; other human resources, employment and employee benefits matters; and the treatment of equity-based awards granted by the Company prior to the Separation.
The Company entered into two transition services agreements with Mural. 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. 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
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. 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. 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.
The following table summarizes expenses of the discontinued operations for the years ended December 31, 2023, 2022 and 2021:
Year Ended December 31,
(In thousands)
2023
2022
2021
Operating expenses from discontinued operations
Cost of goods manufactured
$
39
$
40
$
64
Research and development
116,177
121,140
115,602
Selling, general and administrative
48,587
14,996
11,367
Total operating expenses from discontinued operations
164,803
136,176
127,033
Operating loss from discontinued operations
( 164,803
)
( 136,176
)
( 127,033
)
Income tax benefit from discontinued operations
( 1,403
)
( 11,061
)
( 2,463
)
Net loss and comprehensive loss from discontinued operations
$
( 163,400
)
$
( 125,115
)
$
( 124,570
)
F- 19
ALKERMES PLC AND SUBSIDIARIES
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. 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. 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:
(In thousands)
December 31, 2022
ASSETS
Current Assets:
Prepaid expenses and other current assets
$
2,324
Total current assets
2,324
Right-of-use assets
18,316
Property, plant and equipment, net
10,617
Goodwill
7,800
Deferred tax asset
1,030
Assets from discontinued operations
$
40,087
LIABILITIES
Current Liabilities:
Operating lease liabilities—short-term
$
5,844
Total current liabilities
5,844
Operating lease liability—long-term
13,542
Liabilities related to discontinued operations
$
19,386
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, 2022 and 2021:
Year Ended December 31,
2023
2022
2021
(In thousands)
OPERATING ACTIVITIES:
Depreciation
$
2,319
$
1,539
$
1,474
Share-based compensation expense
8,188
6,577
5,190
Right-of-use assets
3,803
5,909
5,703
Operating lease liabilities
( 3,938
)
( 5,920
)
( 4,758
)
INVESTING ACTIVITIES:
Additions of property, plant and equipment
$
( 1,798
)
$
( 5,510
)
$
( 4,385
)
4. REVENUE FROM CONTRACTS WITH CUSTOMERS
During the years ended December 31, 2023, 2022 and 2021, the Company recorded product sales, net, as follows:
Year Ended December 31,
(In thousands)
2023
2022
2021
VIVITROL
$
400,419
$
379,478
$
343,853
ARISTADA and ARISTADA INITIO
327,690
302,052
275,356
LYBALVI
191,889
96,022
8,215
Total product sales, net
$
919,998
$
777,552
$
627,424
F- 20
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
During the years ended December 31, 2023, 2022 and 2021, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows:
Year Ended December 31, 2023
(In thousands)
Manufacturing Revenue
Royalty Revenue
Total
Long-acting INVEGA products (1)
$
—
$
486,101
$
486,101
VUMERITY
42,886
86,440
129,326
RISPERDAL CONSTA
36,123
1,153
37,276
Other
63,489
27,196
90,685
$
142,498
$
600,890
$
743,388
Year Ended December 31, 2022
(In thousands)
Manufacturing Revenue
Royalty Revenue
Total
Long-acting INVEGA products (1)
$
—
$
115,655
$
115,655
VUMERITY
32,493
83,003
115,496
RISPERDAL CONSTA
42,670
7,243
49,913
Other
37,211
13,708
50,919
$
112,374
$
219,609
$
331,983
Year Ended December 31, 2021
(In thousands)
Manufacturing Revenue
Royalty Revenue
Total
Long-acting INVEGA products (1)
$
—
$
303,106
$
303,106
VUMERITY
25,808
61,614
87,422
RISPERDAL CONSTA
40,413
10,456
50,869
Other
39,407
61,003
100,410
$
105,628
$
436,179
$
541,807
(1) “long-acting INVEGA products”: INVEGA SUSTENNA/XEPLION (paliperidone palmitate), INVEGA TRINZA/TREVICTA (paliperidone palmitate) and INVEGA HAFYERA/BYANNLI (paliperidone palmitate).
In November 2021, the Company received notice of partial termination of an exclusive license agreement with Janssen. Under this license agreement, the Company provided Janssen with rights to, and know-how, training and technical assistance in respect of, the Company’s small particle pharmaceutical compound technology, known as NanoCrystal technology, which was used to develop the long-acting INVEGA products. When the partial termination became effective in February 2022, Janssen ceased paying royalties related to sales of INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA. Accordingly, the Company ceased recognizing royalty revenue related to sales of these products in February 2022. In April 2022, the Company commenced binding arbitration proceedings related to, among other things, Janssen’s partial termination of this license agreement and Janssen’s royalty and other obligations under the agreement. In May 2023, the arbitral tribunal (the “Tribunal”) in the arbitration proceedings issued a final award (the “Final Award”) which concluded the arbitration proceedings. The Final Award provided, among other things, that the Company was due back royalties of $ 195.4 million, inclusive of $ 8.1 million in late-payment interest related to 2022 U.S. net sales of the long-acting INVEGA products, which amount the Company received from Janssen in the second quarter of 2023, and is entitled to 2023 and future royalty revenues from Janssen related to net sales of INVEGA SUSTENNA through August 20, 2024, INVEGA TRINZA through the second quarter of 2030 (but no later than May 2030 when the license agreement expires) and INVEGA HAFYERA through May 2030 (when the license agreement expires).
Following issuance of the Final Award, the Company recognized royalty revenues related to the back royalties noted above and resumed recognizing royalty revenue related to ongoing U.S. sales of the long-acting INVEGA products. During 2023, the Company recor ded $ 486.1 mill ion in royalty revenue from sales of the long-acting INVEGA products, including $ 195.4 million related to back royalties and associated interest related to net sales of the long-acting INVEGA in the U.S. in 2022 and resumed recognizing royalty revenue related to worldwide net sales of the long-acting INVEGA products of approximately $ 290.7 million, as compared to royalty revenue of $ 115.7 million during 2022.
In October 2022 and November 2022, an arbitration panel found that the Company must return to Acorda Therapeutics, Inc. (“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. These amounts represented a portion of the royalty revenue paid to the Company by Acorda since July 2020 related to AMPYRA. The Company paid
F- 21
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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. However, as a result of the arbitration ruling, the Company reversed the $ 3.2 million as the panel found that the Company was no longer entitled to be paid those royalties. During the three months ended September 30, 2022, the Company recorded both the $ 18.3 million in repayments and the $ 3.2 million reversal as reversals of royalty revenue within “Manufacturing and royalty revenue” in the accompanying consolidated statements of operations and comprehensive income (loss). The amounts related to such arbitration ruling were included as part of “Other” within the manufacturing and royalty revenue table above for the year ended December 31, 2022. As a result of the arbitration ruling, the Company has no contractual obligation to manufacture and supply AMPYRA or contractual right to receive future manufacturing or royalty revenue related to AMPYRA. Refer to Note 19, Commitments and Contingent Liabilities within the “Notes to Consolidated Financial Statements” in this Annual Report for information regarding additional legal proceedings related to the arbitration with Acorda.
5. INVESTMENTS
Investments consist of the following:
Gross Unrealized
Losses
Amortized
Less than
Greater than
Estimated
December 31, 2023
Cost
Gains
One Year
One Year
Fair Value
Short-term investments:
Available-for-sale securities:
U.S. government and agency debt securities
$
199,708
$
758
$
( 36
)
$
( 611
)
$
199,819
Corporate debt securities
112,055
703
( 15
)
( 536
)
112,207
Non-U.S. government debt securities
4,004
—
—
( 8
)
3,996
Total short-term investments
315,767
1,461
( 51
)
( 1,155
)
316,022
Long-term investments:
Available-for-sale securities:
U.S. government and agency debt securities
19,392
—
( 27
)
( 315
)
19,050
Corporate debt securities
19,306
—
—
( 289
)
19,017
38,698
—
( 27
)
( 604
)
38,067
Held-to-maturity securities:
Certificates of deposit
1,820
—
—
—
1,820
Total long-term investments
40,518
—
( 27
)
( 604
)
39,887
Total investments
$
356,285
$
1,461
$
( 78
)
$
( 1,759
)
$
355,909
December 31, 2022
Short-term investments:
Available-for-sale securities:
Corporate debt securities
$
141,418
$
—
$
( 424
)
$
( 2,054
)
$
138,940
U.S. government and agency debt securities
143,710
16
( 266
)
( 1,289
)
142,171
Non-U.S. government debt securities
35,455
—
( 28
)
( 546
)
34,881
Total short-term investments
320,583
16
( 718
)
( 3,889
)
315,992
Long-term investments:
Available-for-sale securities:
Corporate debt securities
68,229
—
( 1,550
)
( 676
)
66,003
U.S. government and agency debt securities
62,220
—
( 917
)
( 1,424
)
59,879
Non-U.S. government debt securities
4,099
—
—
( 191
)
3,908
134,548
—
( 2,467
)
( 2,291
)
129,790
Held-to-maturity securities:
Certificates of deposit
1,820
—
—
—
1,820
Total long-term investments
136,368
—
( 2,467
)
( 2,291
)
131,610
Total investments
$
456,951
$
16
$
( 3,185
)
$
( 6,180
)
$
447,602
At December 31, 2023, the Company reviewed its investment portfolio to assess whether the unrealized losses on its available-for-sale investments were temporary. Investments with unrealized losses consisted primarily of corporate debt securities and debt securities issued and backed by U.S. agencies and the U.S. government. At December 31, 2023, 97 of the Company’s 231 investment securities were in an unrealized loss position and had an aggregate estimated fair value of $ 135.0 million. Approximately 36 % and
F- 22
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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. government or its agencies, respectively. The primary reason for the unrealized losses in the Company’s investment portfolio is that its investments are fixed-rate securities acquired in a rising interest rate environment. In making the determination whether the decline in fair value of these securities was temporary, the Company evaluated whether it intended to sell the security and whether it was more likely than not that the Company would be required to sell the security before recovering its amortized cost basis. The Company has the intent and ability to hold these investments until recovery, which may be at maturity.
Realized gains and losses on the sales and maturities of investments, which were identified using the specific identification method, were as follows:
Year Ended December 31,
(In thousands)
2023
2022
2021
Proceeds from the sales and maturities of investments
$
355,522
$
281,627
$
295,010
Realized gains
$
—
$
—
$
34
Realized losses
$
—
$
529
$
977
The Company’s available-for-sale and held-to-maturity securities at December 31, 2023 had contractual maturities in the following periods:
Available-for-sale
Held-to-maturity
Amortized
Estimated
Amortized
Estimated
(In thousands)
Cost
Fair Value
Cost
Fair Value
Within 1 year
$
207,005
$
205,950
$
1,820
$
1,820
After 1 year through 5 years
147,460
148,139
—
—
Total
$
354,465
$
354,089
$
1,820
$
1,820
6. FAIR VALUE
The following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring basis and indicates the fair value hierarchy and the valuation techniques the Company utilized to determine such fair value:
December 31,
(In thousands)
2023
Level 1
Level 2
Level 3
Assets:
Cash equivalents
$
34,316
$
34,316
$
—
$
—
U.S. government and agency debt securities
218,869
181,041
37,828
—
Corporate debt securities
131,224
—
131,224
—
Non-U.S. government debt securities
3,996
—
3,996
—
Total
$
388,405
$
215,357
$
173,048
$
—
December 31,
2022
Level 1
Level 2
Level 3
Assets:
Cash equivalents
$
19,857
$
19,857
$
—
$
—
U.S. government and agency debt securities
202,050
168,639
33,411
—
Corporate debt securities
204,943
—
204,943
—
Non-U.S. government debt securities
38,789
—
38,789
—
Total
$
465,639
$
188,496
$
277,143
$
—
The Company transfers its financial assets and liabilities, measured at fair value on a recurring basis, between the fair value hierarchies at the end of each reporting period.
There were no transfers of any securities between levels during the year ended December 31, 2023. At December 31, 2023, the Company had no investments with fair values that were determined using Level 3 inputs.
F- 23
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Company’s investments in U.S. government and agency debt securities, non-U.S. government agency debt securities and corporate debt securities classified as Level 2 within the fair value hierarchy were initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing market-observable data. The market-observable data included reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. 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.
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. (“Recro”) and Recro Gainesville LLC (such transaction the “Gainesville Transaction”). 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.
In November 2019, Recro Pharma, Inc. (“Recro”) spun out its acute care segment to Baudax Bio, Inc. (“Baudax”), a publicly-traded pharmaceutical company. As part of this transaction, Recro’s obligations to pay certain contingent consideration from the Gainesville Transaction were assigned and/or transferred to Baudax.
In Baudax’s Quarterly Report on Form 10-Q for the period ended September 30, 2022, Baudax continued to include disclosures regarding its ability to continue as a going concern, which first appeared in its Annual Report on Form 10-K for the period ended December 31, 2021. In March 2022, Baudax reduced its workforce by approximately 80 %, which was designed to reduce its operational expenses and conserve its cash resources. 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 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. 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.
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.
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.
7. INVENTORY
Inventory consists of the following:
December 31,
December 31,
(In thousands)
2023
2022
Raw materials
$
71,416
$
61,064
Work in process
68,843
76,228
Finished goods (1)
46,147
44,126
Total inventory
$
186,406
$
181,418
(1) At December 31, 2023 and 2022, the Company had $ 33.9 million and $ 30.9 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider.
F- 24
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
8. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consists of the following:
December 31,
December 31,
(In thousands)
2023 (1)
2022 (1)
Land
$
957
$
947
Building and improvements
132,735
104,666
Furniture, fixtures and equipment
237,728
222,408
Leasehold improvements
39,893
31,642
Construction in progress
45,791
78,017
Subtotal
457,104
437,680
Less: accumulated depreciation
( 230,161
)
( 214,761
)
Total property, plant and equipment, net
$
226,943
$
222,919
(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. 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.
Depreciation expens e was $ 25.7 million, $ 26.3 million and $ 23.3 million for the years ended December 31, 2023, 2022 and 2021, respectively. Also, during the years ended December 31, 2023, 2022 and 2021, the Company wrote off furniture, fixtures and equipment that had an approximate carrying valu e of $ 1.7 million, $ 0.5 million and $ 0.1 million, respectively, at the time of disposition.
Amounts included as construction in progress in the consolidated balance sheets primarily include capital expenditures at the Company’s manufacturing facility in Wilmington, Ohio. 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. 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.
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. 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.
9. GOODWILL AND INTANGIBLE ASSETS
Goodwill and intangible assets consists of the following:
December 31, 2023
December 31, 2022
(In thousands)
Weighted Amortizable Life (Years)
Gross Carrying Amount
Accumulated Amortization
Net Carrying Amount
Gross Carrying Amount
Accumulated Amortization
Net Carrying Amount
Goodwill (1)
$
83,027
$
—
$
83,027
$
83,027
$
—
$
83,027
Finite-lived intangible assets:
Collaboration agreements
12
$
465,590
$
( 465,590
)
$
—
$
465,590
$
( 435,887
)
$
29,703
Capitalized IP
11 - 13
118,160
( 116,169
)
1,991
118,160
( 110,183
)
7,977
Total
$
583,750
$
( 581,759
)
$
1,991
$
583,750
$
( 546,070
)
$
37,680
(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. 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.
F- 25
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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. The Company recorded $ 35.7 million, $ 36.4 million and $ 38.1 million of amortization expense related to its finite-lived intangible assets during the years ended December 31, 2023, 2022 and 2021, respectively. 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, 2023. 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. 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. 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.
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.
10. LEASES
All of the Company’s leases are accounted for as operating leases. The Company leases approximately 231,000 square feet of office and laboratory space located at 900 Winter Street in Waltham, Massachusetts (the “900 Winter Street Lease”). 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.
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”). Under the terms of the Assignment, Mural US assumed all of Alkermes US’ obligations under the 852 Winter Street Lease. In accordance with FASB ASC 842, Leases , as the Company can no longer access or direct the use of the asset following the Assignment, the 852 Winter Street Lease no longer meets the definition of a lease for the Company. 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.
In December 2022, the Company exercised an early payment option included within the terms of the 900 Winter Street Lease. 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. Subsequently, the Company made the early lease payment of $ 15.3 million in December 2022. 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.
At December 31, 2023 and 2022, the operating leases held by the Company had a weighted average incremental borrowing rate of 4.4 % and 5.5 %, respectively, and a weighted average remaining lease term of 8.7 years and 9.6 years, respectively. During the years ended December 31, 2023, 2022 and 2021, cash paid for amounts included for the measurement of lease liabilities was $ 10.3 million, $ 27.0 million and $ 11.8 million, respectively. The Company recorded operating lease expense of $ 10.2 million, $ 10.7 million and $ 11.3 million for the years ended December 31, 2023, 2022 and 2021, respectively.
Future lease payments under non-cancelable leases as of December 31, 2023 consisted of the following:
December 31,
(In thousands)
2023
2024
$
10,148
2025
10,248
2026
10,319
2027
9,509
2028
9,574
Thereafter
59,665
Total operating lease payments
$
109,463
Less: imputed interest
( 28,008
)
Total operating lease liabilities
$
81,455
F- 26
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
11. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consists of the following:
December 31,
December 31,
(In thousands)
2023
2022
Accounts payable
$
65,649
$
32,843
Accrued compensation
83,107
79,085
Accrued other
91,805
108,161
Total accounts payable and accrued expenses
$
240,561
$
220,089
A summary of the Company’s current provision for sales discounts, allowances and reserves is as follows:
December 31,
December 31,
(In thousands)
2023
2022
Medicaid rebates
$
213,845
$
208,332
Product discounts
15,121
13,204
Medicare Part D
20,569
18,409
Other
14,106
12,170
Total accrued sales discounts, allowances and reserves
$
263,641
$
252,115
Included in accounts payable was approximately $ 34.5 million and $ 0.8 million of amounts payable related to state Medicaid rebates as of December 31, 2023 and 2022, respectively.
12. LONG-TERM DEBT
Long-term debt consists of the following:
December 31,
December 31,
(In thousands)
2023
2022
2026 Term Loans, due March 12, 2026
$
290,730
$
293,270
Less: current portion
( 3,000
)
( 3,000
)
Long-term debt
$
287,730
$
290,270
The Company’s outstanding term loans mature on March 12, 2026 (the “2026 Term Loans”). 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. 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 %.
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. 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. The 2026 Term Loans also contain customary affirmative covenants and events of default. The Company was in compliance with its debt covenants at December 31, 2023.
Scheduled maturities with respect to the 2026 Term Loans are as follows (in thousands):
Year Ending December 31:
2024
$
3,000
2025
3,000
2026
285,750
Total
$
291,750
The Company is subject to mandatory prepayments of principal if certain excess cash flow thresholds, as defined in the 2026 Term Loans, are met. To date, the Company has not been required to make any such mandatory prepayments.
F- 27
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
13. EARNINGS (LOSS) PER SHARE
Basic earnings (loss) per ordinary share from continuing operations is calculated based upon net income (loss) from continuing operations available to holders of ordinary shares divided by the weighted average number of ordinary shares outstanding. Basic loss per ordinary share from discontinued operations, is calculated based upon net loss from discontinued operations available to holders of ordinary shares, divided by the weighted average number of ordinary shares outstanding. For the calculation of diluted earnings (loss) per ordinary share from continuing operations and discontinuing operations, the Company utilizes the treasury stock method and adjusts the weighted average number of ordinary shares outstanding for the potential dilutive effect of outstanding ordinary share equivalents such as stock options and RSUs.
Year Ended December 31,
(In thousands)
2023
2022 (1)
2021 (1)
Numerator:
Net income (loss) from continuing operations
$
519,157
$
( 33,152
)
$
76,401
Net (loss) discontinued operations
( 163,400
)
( 125,115
)
( 124,570
)
Net income (loss)
$
355,757
$
( 158,267
)
$
( 48,169
)
Denominator:
Weighted average number of ordinary shares outstanding
166,223
163,742
160,942
Effect of dilutive securities:
Stock options
1,093
—
633
Restricted stock unit awards
2,414
—
3,178
Dilutive ordinary share equivalents
3,507
—
3,811
Shares used in calculating diluted earnings (loss) per ordinary share
169,730
163,742
164,753
(1) Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation.
The following potential ordinary share equivalents were not included in the net loss per share calculation because the effect would have been anti-dilutive:
Year Ended December 31,
(In thousands)
2023
2022
2021 (1)
Stock options
12,422
12,777
14,161
Restricted stock unit awards
2,378
5,040
804
Total
14,800
17,817
14,965
(1) Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation.
14. SHAREHOLDERS’ EQUITY
Share Repurchase Program
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”). 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. The 2024 Repurchase Program has no set expiration date and may be suspended or discontinued at any time. 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. During the years ended December 31, 2023, 2022 and 2021 the Company did no t purchase any ordinary shares under the Prior Repurchase Program.
F- 28
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
15. SHARE-BASED COMPENSATION
Share-Based Compensation Expense
The following table presents share-based compensation expense from continuing and discontinued operations included in the Company’s consolidated statements of operations and comprehensive income (loss):
Year Ended December 31,
(In thousands)
2023
2022
2021
Cost of goods manufactured and sold
$
11,353
$
10,284
$
9,175
Research and development
25,753
23,289
21,396
Selling, general and administrative
55,611
54,104
51,861
Share-based compensation expense from continuing operations
92,717
87,677
82,432
Cost of goods manufactured and sold
—
—
—
Research and development
3,255
4,652
3,481
Selling, general and administrative
4,933
1,925
1,709
Share-based compensation expense from discontinued operations
8,188
6,577
5,190
Total share-based compensation expense
$
100,905
$
94,254
$
87,622
During the years ended December 31, 2023, 2022 and 2021, $ 3.2 million, $ 3.3 million and $ 2.3 million, respectively, of share-based compensation expense was capitalized and recorded as “Inventory” in the accompanying consolidated balance sheets.
Share-Based Compensation Plans
The Company has one share-based compensation plan pursuant to which awards are currently being made: the 2018 Stock Option and Incentive Plan, as amended (the “2018 Plan”). The Company has two share-based compensation plans pursuant to which outstanding awards have been made, but from which no further awards can or will be made: the Alkermes plc Amended and Restated 2008 Stock Option and Incentive Plan, as amended, (the “2008 Plan”) and the Alkermes plc 2011 Stock Option and Incentive Plan, as amended (the “2011 Plan,” and together with the 2018 Plan and the 2008 Plan, the “the Alkermes Stock Option and Incentive Plans”). Effective May 20, 2020, the 2018 Plan was amended such that any shares underlying any outstanding awards granted under the 2011 Plan or the 2008 Plan that are forfeited, canceled, repurchased or otherwise terminated (other than by exercise) from and after such date will become available for issuance pursuant to the 2018 Plan, notwithstanding anything to the contrary in the terms of the 2011 Plan or the 2008 Plan.
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.
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. At December 31, 2023, there were 15.1 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.
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”. 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.
F- 29
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Stock Options
A summary of stock option activity is presented in the following table:
Number of
Weighted Average
Shares
Exercise Price
Outstanding, January 1, 2023
17,596,961
$
33.32
Granted
3,479,898
$
27.88
Conversion Reissuance
357,146
$
32.26
Exercised
( 772,207
)
$
21.70
Expired
( 1,334,719
)
$
37.02
Forfeited
( 1,187,176
)
$
26.56
Outstanding, December 31, 2023
18,139,903
$
32.28
Exercisable, December 31, 2023
11,054,082
$
37.24
The weighted average grant date fair value of stock options granted during the years ended December 31, 2023, 2022 and 2021 was $ 13.74 , $ 12.62 and $ 10.09 , respectively. The aggregate intrinsic value of stock options exercised during the years ended December 31, 2023, 2022 and 2021 was $ 6.0 million, $ 11.6 million and $ 8.3 million, respectively.
At December 31, 2023, there were 6.9 million stock options expected to vest, with a weighted average exercise price of $ 24.46 per share, a weighted average contractual remaining life of 8.0 years and an aggregate intrinsic value of $ 24.6 million. At December 31, 2023, the aggregate intrinsic value of stock options exercisable was $ 29.4 million with a weighted average remaining contractual term of 4.5 years. The number of stock options expected to vest was determined by applying the pre-vesting forfeiture rate to the total number of outstanding options. The intrinsic value of a stock option is the amount by which the market value of the underlying shares exceeds the exercise price of the stock option.
At December 31, 2023, there was $ 33.0 million of unrecognized share-based compensation expense related to unvested stock options, which is expected to be recognized over a weighted average period of 1.9 years.
Time-Based Restricted Stock Unit Awards
A summary of time-based RSU activity is presented in the following table:
Weighted Average
Number of
Shares
Grant Date
Fair Value
Unvested, January 1, 2023
6,625,422
$
23.34
Granted
2,884,122
$
27.65
Conversion reissuance
110,015
$
24.19
Forfeited
( 1,368,705
)
$
25.17
Vested
( 2,593,276
)
$
24.31
Unvested, December 31, 2023
5,657,578
$
24.18
The weighted average grant date fair values of time-vesting RSUs granted during the years ended December 31, 2023, 2022 and 2021 were $ 27.65 , $ 25.27 and $ 20.83 , respectively. The total fair value of time-vesting RSUs that vested during the years ended December 31, 2023, 2022 and 2021, was $ 63.0 million, $ 54.3 million and $ 56.3 million, respectively.
At December 31, 2023, there was $ 55.4 million of total unrecognized share-based compensation expense related to unvested time-vesting RSUs, which will be recognized over a weighted average remaining contractual term of 1.9 years.
Performance-Based Restricted Stock Unit Awards
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.
F- 30
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
A summary of performance-based RSU activity is presented in the following table:
Weighted Average
Number of
Shares
Grant Date
Fair Value
Unvested, January 1, 2023
1,349,634
$
26.05
Granted
667,565
$
29.91
Conversion reissuance
30,244
$
27.15
Forfeited
( 248,711
)
$
24.06
Vested
( 252,375
)
$
23.43
Unvested, December 31, 2023
1,546,357
$
27.95
The weighted average grant date fair values of performance-based RSUs granted during the years ended December 31, 2023, 2022 and 2021 were $ 29.91 , $ 30.73 and $ 23.09 , respectively. 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. 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.
The Company has additional unrecognized share-based compensation expense related to performance-based RSUs that were granted in February 2021. As of December 31, 2023, the financial performance criteria for these awards were deemed not probable of being achieved. On February 8, 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. 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. The share-based compensation expense related to these achievements will be recognized in 2024.
16. COLLABORATIVE ARRANGEMENTS
The Company has entered into several collaborative arrangements to develop and commercialize products and, in connection with such arrangements, to access technologies, financial, marketing, manufacturing and other resources. Refer to the “Patents and Proprietary Rights” section in “Item 1— Business” of this Annual Report for information with respect to IP protection for these products. The collaboration revenue the Company has earned in the years ended December 31, 2023, 2022 and 2021 is summarized in Note 4, Revenue from Contracts with Customers within the notes to the consolidated financial statements in this Annual Report.
The Company’s significant collaborative arrangements are described below:
Janssen
INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI
Under an exclusive license agreement with Janssen, the Company provided Janssen with rights to, and know-how, training and technical assistance in respect of, the Company’s small particle pharmaceutical compound technology, known as NanoCrystal technology, which was used to develop the long-acting INVEGA products, and the Company received milestone payments from Janssen upon the achievement of certain development goals from Janssen; there are no further milestones to be earned under this agreement. 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. 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. 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. The know-how royalty rate resets to 3.5 % at the beginning of each calendar year and is payable until 15 years from first commercial sale of a product in each individual country, subject to expiry of the agreement. These royalty payments may be reduced in any country based on patent litigation or on competing products achieving certain minimum sales thresholds. The license agreement, unless earlier terminated, terminates upon the expiration of the last of the patents subject to the agreement. After expiration, Janssen retains a non-exclusive, royalty-free license to develop, manufacture and commercialize the products, subject to certain surviving obligations. Janssen may terminate the license agreement in whole or in part upon three months’ notice to the Company. 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.
F- 31
ALKERMES PLC AND SUBSIDIARIES
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. sales of INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA. In April 2022, the Company commenced binding arbitration proceedings related to, among other things, Janssen’s partial termination of this license agreement and Janssen’s royalty and other obligations under the agreement. In May 2023, the Tribunal in the arbitration proceedings issued a Final Award that served to reinstate the Janssen royalties and required payment by Janssen of back royalties and interest for amounts owed but not yet paid since the effective date of the partial termination. The Final Award also provided, among other things, that the Company was entitled to royalty revenues from Janssen related to net sales of INVEGA SUSTENNA through August 20, 2024, INVEGA TRINZA through the second quarter of 2030 (but no later than May 2030 when the license agreement expires) and INVEGA HAFYERA through May 2030 (when the license agreement expires).
RISPERDAL CONSTA
Under a product development agreement, the Company collaborated with Janssen on the development of RISPERDAL CONSTA. 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.
Under two license agreements, the Company granted Janssen and an affiliate of Janssen exclusive worldwide licenses to use and sell RISPERDAL CONSTA. Under its license agreements with Janssen, the Company receives royalty payments equal to 2.5 % of Janssen’s end-market net sales of RISPERDAL CONSTA in each country where the license is in effect based on the quarter when the product is sold by Janssen. This royalty may be reduced in any country based on lack of patent coverage and significant competition from generic versions of the product. Janssen can terminate the license agreements upon 30 days ’ prior written notice to the Company. Either party may terminate the license agreements by written notice following a breach which continues for 90 days after the delivery of written notice thereof or upon the other party’s insolvency. The licenses granted to Janssen expire on a country-by-country basis upon the later of: (i) the expiration of the last patent claiming the product in such country; or (ii) 15 years after the date of the first commercial sale of the product in such country, provided that in no event will the license granted to Janssen expire later than the twentieth anniversary of the first commercial sale of the product in each such country, with the exception of Canada, France, Germany, Italy, Japan, Spain and the United Kingdom, in each case where the fifteen-year minimum shall pertain regardless. After expiration, Janssen retains a non-exclusive, royalty-free license to manufacture, use and sell RISPERDAL CONSTA.
The Company exclusively manufactures RISPERDAL CONSTA at its Wilmington, Ohio facility for commercial sale. Under its manufacturing and supply agreement with Janssen, the Company records manufacturing revenues when product is fully manufactured and approved for shipment by both Janssen and the Company. Revenue is based on a percentage of Janssen’s net unit sales price for RISPERDAL CONSTA for the applicable calendar year. This percentage is determined based on Janssen’s unit demand for such calendar year and varies based on the volume of units shipped, with a minimum manufacturing fee of 7.5 %. Either party may terminate the manufacturing and supply agreement upon a material breach by the other party, which is not resolved within 60 days after receipt of a written notice specifying the material breach or upon written notice in the event of the other party’s insolvency or bankruptcy. Janssen may terminate the agreement upon six months ’ written notice to the Company. In the event that Janssen terminates the manufacturing and supply agreement without terminating the license agreements, the royalty rate payable to the Company on Janssen’s net sales of RISPERDAL CONSTA would increase from 2.5 % to 5.0 %.
Biogen
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.
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. 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.
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. 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. 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.
F- 32
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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. 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. Biogen has the right to terminate the license and collaboration agreement at will, on a product-by-product basis or in its entirety upon 180 days’ prior notice to the Company. Either party has the right to terminate the license and collaboration agreement following any governmental prohibition of the transactions effected by the agreement, or in connection with an insolvency event involving the other party. 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.
17. INCOME TAXES
The Company’s (benefit) provision for income taxes from continuing operations consists of the following:
Year Ended December 31,
(In thousands)
2023
2022 (1)
2021 (1)
Current income tax (benefit) provision:
U.S. federal
$
( 981
)
$
11,169
$
2,251
U.S. state
722
4,401
797
Rest of world
—
—
3
Deferred income tax (benefit) provision:
U.S. federal
10,192
( 10,536
)
9,372
U.S. state
( 507
)
( 3,010
)
( 1,097
)
Ireland
( 107,064
)
—
—
Total tax (benefit) provision
$
( 97,638
)
$
2,024
$
11,326
(1) Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation.
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. and Ireland. The income tax provisions in 2022 and 2021 were primarily due to U.S. federal and state taxes on income earned in the U.S. and the tax impact of employee equity activity.
In December 2023, the IRS issued Notice 2024-12 that provided clarity on the application of Section 174. 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.
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. The tax benefits included within discontinued operations were $ 1.4 million, $ 11.1 million, and $ 2.5 million for the years ended December 31, 2023, 2022, and 2021, respectively.
No provision for income tax has been provided on undistributed earnings of the Company’s foreign subsidiaries because such earnings are indefinitely reinvested in the foreign operations. Cumulative unremitted earnings of U.S. subsidiaries totaled approximately $ 797.0 million at December 31, 2023. In the event of a repatriation of those earnings in the form of dividends or otherwise, the Company may be liable for income taxes, subject to adjustment, if any, for foreign tax credits and foreign withholding taxes payable to foreign tax authorities. The Company estimates that approximately $ 70.8 million of income taxes would be payable on the repatriation of the unremitted earnings to Ireland.
F- 33
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The distribution of the Company’s income (loss) before the (benefit) provision for income taxes by geographical area consists of the following:
Year Ended December 31,
(In thousands)
2023
2022 (1)
2021 (1)
Ireland
$
411,767
$
( 32,198
)
$
85,415
U.S.
9,752
1,070
2,312
Income (loss) from continuing operations before (benefit) provision for income taxes
$
421,519
$
( 31,128
)
$
87,727
(1) Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation.
The components of the Company’s net deferred tax assets consist of the following:
December 31,
December 31,
(In thousands)
2023
2022 (1)
Deferred tax assets:
Net operating loss carryforwards
$
195,658
$
238,128
Research and development expenses
49,206
66,464
Accrued expenses and reserves
56,083
51,362
Share-based compensation
37,727
39,333
Tax credits
27,116
22,932
Other
5,582
6,543
Less: valuation allowance
( 129,296
)
( 268,067
)
Total deferred tax assets
242,076
156,695
Deferred tax liabilities:
Property, plant and equipment
( 44,019
)
( 41,169
)
Other
( 2,716
)
( 1,502
)
Total deferred tax liabilities
( 46,735
)
( 42,671
)
Net deferred tax assets
$
195,341
$
114,024
(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:
(In thousands)
Balance at Beginning of Period (1)
(Additions) / Reductions (2)
Balance at End of Period (1)
Deferred tax asset valuation allowance for the year ended December 31, 2021
$
( 253,649
)
$
4,537
$
( 249,112
)
Deferred tax asset valuation allowance for the year ended December 31, 2022
$
( 249,112
)
$
( 22,405
)
$
( 271,517
)
Deferred tax asset valuation allowance for the year ended December 31, 2023
$
( 271,517
)
$
142,221
$
( 129,296
)
(1) Inclusive of continuing and discontinued operations for all periods other than the balance at December 31, 2023.
(2) (Additions) reductions represent continuing and discontinued operations. 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. The (additions) reductions in 2022 and 2021 relate primarily to Irish net operating losses (“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. During the year ended December 31, 2023, the Company: (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); (ii) successfully completed the Separation; and (iii) recorded significant pre-tax income due to multiple factors, including the growth of its proprietary revenues and items (i) and (ii) above. 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. 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. 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, 2023, the Company maintained a valuation allowance of $ 27.3 million against certain U.S. state deferred tax assets and $ 102.0 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.
F- 34
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
If the Company incurs losses in the U.S. 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. The Company will continue to monitor the need for a valuation allowance against its deferred tax assets on a quarterly basis.
As of December 31, 2023, the Company had $ 1.3 billion of Irish NOL carryforwards, $ 14.6 million of U.S. 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. These loss and credit carryforwards are available to reduce certain future Irish and foreign taxable income and tax. These loss and credit carryforwards are subject to review and possible adjustment by the appropriate taxing authorities. 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. Included within these loss and credit carryforwards are $ 14.6 million of U.S. federal NOL carryforwards and $ 6.3 million of state NOL carryforwards, acquired as part of the acquisition of Rodin Therapeutics, Inc. (“Rodin”), each of which are subject to a $ 0.5 million annual limitation.
A reconciliation of the Company’s statutory tax rate to its effective tax rate is as follows:
Year Ended December 31,
(In thousands, except percentage amounts)
2023
2022 (1)
2021 (1)
Statutory tax rate
12.5
%
12.5
%
12.5
%
Income (loss) from continuing operations before income taxes at statutory rate
$
52,690
$
( 3,891
)
$
10,966
Share-based compensation
4,177
4,347
7,716
Foreign rate differential (2)
4,701
521
5,159
Change in valuation allowance
( 142,424
)
1,102
( 23,024
)
Intercompany amounts (3)
( 16,551
)
( 1,694
)
10,707
Irish rate differential (4)
235
4,926
1,817
Uncertain tax positions
( 234
)
602
704
Non-deductible lobbying expenses
705
775
637
U.S. state income taxes, net of U.S. federal benefit
347
1,272
( 260
)
In-process R&D (5)
—
—
2,724
Foreign derived intangible income
—
( 4,530
)
( 3,125
)
R&D credit
( 2,823
)
( 2,531
)
( 2,871
)
Other permanent items (6)
1,539
1,125
176
Income tax (benefit) provision
$
( 97,638
)
$
2,024
$
11,326
Effective tax rate
( 23.2
)
%
( 6.5
)
%
12.9
%
(1) Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation.
(2) Represents income or losses of U.S. subsidiaries, subject to tax at a rate other than the Irish statutory rate.
(3) Intercompany amounts include cross-territory eliminations, the pre-tax effect of which has been eliminated in arriving at the Company's consolidated income (loss) before taxes from continuing operations. In 2023, this included a tax benefit of $ 15.7 million related to the intercompany transfer of inventory that was owned by the Company at December 31, 2023.
(4) Represents income or losses of Irish companies subject to tax at a rate other than the Irish statutory rate.
(5) Represents the tax effect of the research and development expense recorded in connection with the acquisition of Rodin.
(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.
F- 35
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows:
Unrecognized
(In thousands)
Tax Benefits
Balance, December 31, 2020
$
7,668
Reductions based on tax positions related to prior periods
( 27
)
Additions based on tax positions related to the current period
731
Balance, December 31, 2021
$
8,372
Reductions based on the lapse of applicable statutes of limitations
( 438
)
Additions based on tax positions related to prior periods
449
Additions based on tax positions related to the current period
590
Balance, December 31, 2022
$
8,973
Reductions based on the lapse of applicable statutes of limitations
( 1,073
)
Additions based on tax positions related to the prior period
281
Additions based on tax positions related to the current period
558
Balance, December 31, 2023
$
8,739
The unrecognized tax benefits at December 31, 2023, if recognized, would affect the Company’s effective tax rate. The Company does not anticipate that the amount of existing unrecognized tax benefits will materially increase or decrease within the next 12 months. The Company has elected to include interest and penalties related to uncertain tax positions as a component of its provision for taxes. For the years ended December 31, 2023, 2022 and 2021, the Company’s accrued interest and penalties related to uncertain tax positions were not material.
The Company’s major taxing jurisdictions include Ireland and the U.S. (federal and state). These jurisdictions have varying statutes of limitations. In the U.S., the 2020 through 2023 fiscal years remain subject to examination by the respective tax authorities, however, some states have longer statutes of limitations and additional fiscal years remain subject to examination. In Ireland, the 2019 through 2023 fiscal years remain subject to examination by the Irish tax authorities. Additionally, because of the Company’s Irish and U.S. loss carryforwards and credit carryforwards, certain tax returns from fiscal years 2002 onward may also be examined. These years generally remain open for three to four years after the loss carryforwards and credit carryforwards have been utilized.
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”). 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. 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. In connection with the closure, the Company received a refund of approximately € 2.2 million from the LTA. 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.
18. RESTRUCTURING
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”). 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. 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).
Activity related to the Restructuring during the year ended December 31, 2023 was as follows:
(In thousands)
Balance, December 31, 2022
$
—
Restructuring charge
5,969
Amounts paid during the period:
Severance
( 3,932
)
Benefits
( 520
)
Outplacement services
( 183
)
Balance, December 31, 2023
$
1,334
F- 36
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
19. COMMITMENTS AND CONTINGENT LIABILITIES
Litigation
From time to time, the Company may be subject to legal proceedings and claims in the ordinary course of business. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated, the Company would accrue a liability for the estimated loss. Because of uncertainties related to claims and litigation, accruals are based on the Company’s best estimates, utilizing all available information. On a periodic basis, as additional information becomes available, or based on specific events such as the outcome of litigation or settlement of claims, the Company may reassess the potential liability related to these matters and may revise these estimates, which could result in material adverse adjustments to the Company’s operating results. At December 31, 2023, there were no potential material losses from claims, asserted or unasserted, or legal proceedings that the Company determined were probable of occurring.
INVEGA SUSTENNA ANDA Litigation
Janssen Pharmaceutica and Janssen Pharmaceuticals, Inc. initiated patent infringement lawsuits in the U.S. District Court for the District of New Jersey (the “NJ District Court”) in January 2018 against Teva Pharmaceuticals USA, Inc. (“Teva”) and Teva Pharmaceuticals Industries, Ltd. (“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. (“Pharmascience”), Mallinckrodt plc, and SpecGX LLC (the “Pharmascience Lawsuit”), and in February 2022 against Accord Healthcare, Inc., Accord Healthcare, Ltd. and Intas Pharmaceuticals, Ltd (“Accord” and such lawsuit, the “Accord Lawsuit”), and in the U.S. 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. (“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. Patent No. 9,439,906. In October 2021, the NJ District Court entered a judgment in favor of the Janssen entities in the Teva Lawsuit. 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. The Teva entities and Mylan Labs each filed notices of appeal of their respective judgments with the U.S. Court of Appeals for the Federal Circuit, which were consolidated in January 2022 (the “Teva Appeal”). A trial was held in the Tolmar Lawsuit in October 2023. The Pharmascience Lawsuit and the Accord Lawsuit were administratively terminated in July 2022, pending the outcome of the Teva Appeal. The Company is not a party to any of these proceedings.
INVEGA TRINZA ANDA Litigation
In September 2020, Janssen Pharmaceutica, Janssen Pharmaceuticals, Inc., and Janssen Research & Development, LLC initiated a patent infringement lawsuit in the NJ District Court against Mylan Labs, Mylan, and Mylan Institutional LLC following the filing by Mylan Labs of an ANDA seeking approval from the FDA to market a generic version of INVEGA TRINZA before the expiration of U.S. Patent No. 10,143,693 (the “’693 Patent”). Requested judicial remedies include recovery of litigation costs and injunctive relief. In May 2023, the NJ District Court issued an opinion in favor of the Janssen entities on the issues of infringement and validity of the ’693 Patent and the Mylan entities filed a notice of appeal of the decision. The Company is not a party to this proceeding.
VUMERITY ANDA Litigation
In July 2023, Biogen Inc., Biogen Swiss Manufacturing GmbH and Alkermes Pharma Ireland Limited filed a patent infringement lawsuit in the DE District Court against Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc. and Zydus Lifesciences Limited (collectively, “Zydus”) following the filing by Zydus of an ANDA seeking approval from the FDA to engage in the commercial manufacture, use or sale of a generic version of VUMERITY (diroximel fumarate) delayed-release capsules for oral use, 231 mg, before expiration of the Company’s U.S. Patent Nos. 8,669,281; 9,090,558; and 10,080,733. The filing of the lawsuit triggered a stay of FDA approval of the ANDA for up to 30 months in accordance with the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”). In October 2023, Zydus filed an answer to the complaint.
Government Matters
The Company has received a subpoena and civil investigative demands from U.S. state and federal governmental authorities for documents related to VIVITROL. The Company is cooperating with the investigations.
F- 37
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Product Liability and Other Legal Proceedings
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. The Company intends to vigorously defend itself in these matters.
In addition, in January 2023, Acorda filed a petition with the U.S. District Court for the Southern District of New York (the “NY Southern District Court”) asking the court to confirm in part and modify in part the final arbitral award rendered by an arbitration panel in October 2022 and, as part of the requested modification, seeking an additional approximately $ 66.0 million in damages. In August 2023, the NY Southern District Court confirmed the final arbitral award and declined to modify the final award to increase the damages awarded thereunder. In September 2023, Acorda filed a notice of appeal of the NY Southern District Court decision to the U.S. Court of Appeals for the Federal Circuit (the “Federal Circuit”), and the Company filed a motion to transfer the appeal to the U.S. Court of Appeals for the Second Circuit. On October 10, 2023, Acorda filed an opposition to such motion. 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.
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.
Guarantees
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. Although the Assignment transferred all of the rights, title and interest in, to and under the 852 Winter Street Lease to Mural US as of November 15, 2023, the Company ratified and reaffirmed for the remainder of the lease term its guarantor obligations under that certain Guaranty dated as of May 16, 2014 related to the 852 Winter Street Lease. Upon completion of the Separation, the Assignment was accounted for as a termination of the original lease and the Company de-recognized the right-of-use asset and lease liability related to the 852 Winter Street Lease. At December 31, 2023, the fair value of the guarantee was no t material to the Company.
Purchase Commitments
The Company has open purchase orders for plant and equipment as part of its normal course of business. At December 31, 2023, the Company’s open purchase orders were $ 11.0 million for capital commitments.
F- 38