UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
(Mark One)
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
for the fiscal year ended December 31, 2024
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number: 001-35299
ALKERMES PUBLIC LIMITED COMPANY
(Exact name of registrant as specified in its charter)
Ireland
(State or other jurisdiction of incorporation or organization)
98-1007018
(I.R.S. Employer Identification No.)
Connaught House
1 Burlington Road
Dublin 4, Ireland
(Address of principal executive offices)
D04 C5Y6
(Zip code)
+353-1-772-8000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Ordinary shares, $0.01 par value
ALKS
Nasdaq Global Select Market
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§
232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth
company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer ☒
Accelerated Filer ☐
Non-Accelerated Filer ☐
Smaller Reporting Company ☐
Emerging Growth Company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the
correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the
registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The aggregate market value of the registrant’s ordinary shares held by non-affiliates of the registrant (without admitting that any person whose shares are not included in such
calculation is an affiliate) computed by reference to the price at which the ordinary shares were last sold as of the last business day of the registrant’s most recently completed second
fiscal quarter was $3,943,314,276.
As of February 7, 2025, 162,614,067 ordinary shares were outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the definitive proxy statement for our 2025 Annual General Meeting of Shareholders are incorporated by reference into Part III of this report.
2
ALKERMES PLC AND
SUBSIDIARIES
ANNUAL REPORT ON FORM 10-K
FOR THE YEAR ENDED DECEMBER 31, 2024
INDEX
PART I
Item 1.
Business
6
Item 1A.
Risk Factors
30
Item 1B.
Unresolved Staff Comments
51
Item 1C.
Cybersecurity
51
Item 2.
Properties
52
Item 3.
Legal Proceedings
52
Item 4.
Mine Safety Disclosures
52
PART II
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
53
Item 6.
[Reserved]
55
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
56
Item 7A.
Quantitative and Qualitative Disclosures about Market Risk
66
Item 8.
Financial Statements and Supplementary Data
67
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosures
68
Item 9A.
Controls and Procedures
68
Item 9B.
Other Information
69
Item 9C.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
69
PART III
Item 10.
Directors, Executive Officers and Corporate Governance
70
Item 11.
Executive Compensation
70
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
70
Item 13.
Certain Relationships and Related Transactions, and Director Independence
70
Item 14.
Principal Accounting Fees and Services
70
PART IV
Item 15.
Exhibits and Financial Statement Schedules
71
Item 16.
Form 10-K Summary
77
SIGNATURES
78
3
CAUTIONARY NOTE CONCERNING FORWARD-LOOKING STATEMENTS
This document contains and incorporates by reference “forward-looking statements” within the meaning of Section 27A of the Securities Act of
1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In some cases, these
statements can be identified by the use of forward-looking terminology such as “may,” “will,” “could,” “should,” “would,” “expect,” “anticipate,”
“continue,” “believe,” “plan,” “estimate,” “intend,” or other similar words. These statements discuss future expectations and contain projections of results
of operations or of financial condition, or state trends and known uncertainties or other forward-looking information. Forward-looking statements in this
Annual Report on Form 10-K (this “Annual Report”) may include, without limitation, statements regarding:
•
our expectations regarding our financial performance, including revenues, expenses, liquidity, capital expenditures, income taxes and
profitability;
•
our expectations regarding our products, including expectations related to product development, regulatory filings, approvals and timelines;
therapeutic and commercial value, scope and potential; and the costs and expenses related to such activities and expectations;
•
our expectations regarding the initiation, timing and results of clinical trials of our products;
•
our expectations regarding the competitive, payer, legislative, regulatory and policy landscape, and changes therein, related to our products,
including competition from generic forms of our products or competitive products and development programs; barriers to access or coverage of
our products and potential changes in reimbursement of our products; and legislation, regulations, executive orders, guidance or other measures
that may impact pricing and reimbursement of, and access to, our products;
•
our expectations regarding the financial impact of currency exchange rate fluctuations and valuations;
•
our expectations regarding acquisitions, collaborations, licensing arrangements and other significant agreements with third parties, including
those related to our products, development programs, and other business development opportunities;
•
our expectations regarding the impacts of new legislation, rules and regulations, the adoption of new accounting pronouncements, potential
government shutdowns, or other global, political or economic changes, instability or disruptions;
•
our expectations regarding near-term changes in the nature of our market risk exposures or in our management’s objectives and strategies with
respect to managing such exposures;
•
our expectations regarding future capital requirements and expenditures for our operations and our ability to finance such capital requirements
and expenditures;
•
our expectations regarding the timing, outcome and impact of administrative, regulatory, legal and other proceedings related to our products and
intellectual property (“IP”), including our patents, know-how, and related rights or obligations;
•
our expectations regarding the tax treatment and other anticipated benefits of the completed separation of our oncology business; and
•
other expectations discussed elsewhere in this Annual Report.
Actual results might differ materially from those expressed or implied by these forward-looking statements because these forward-looking
statements are subject to risks, assumptions and uncertainties. In light of these risks, assumptions and uncertainties, the forward-looking expectations
discussed in this Annual Report might not occur. You are cautioned not to place undue reliance on the forward-looking statements in this Annual Report,
which speak only as of the date of this Annual Report. All subsequent written and oral forward-looking statements concerning the matters addressed in this
Annual Report and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or
referred to in this section. Except as required by applicable law or regulation, we do not undertake any obligation to update publicly or revise any forward-
looking statements, whether as a result of new information, future events or otherwise. For information about the risks, assumptions and uncertainties of
our business, see “Item 1A—Risk Factors” in this Annual Report.
This Annual Report may include data that we obtained from industry publications and third-party research, surveys and studies. Industry
publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable,
although they do not guarantee the accuracy or completeness of such information. While we believe that any industry publications and third-party research,
surveys and studies from which data is included in this Annual Report are reliable, we have not independently verified any such data. This Annual Report
may also include data based on our own internal estimates and research. Our internal estimates and research have not been verified by any independent
source and are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Item 1A—Risk Factors”
in this Annual Report. These and other factors could cause our results to differ materially from those expressed or implied in this Annual Report.
4
SUMMARY OF MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS
Our business is subject to numerous material and other risks and uncertainties that you should be aware of. These risks and uncertainties are
described more fully in “Item 1A—Risk Factors” in this Annual Report, and include, but are not limited to, the following:
•
we receive substantial revenue from our key proprietary products, and our success depends on our ability to successfully manufacture and
commercialize such products;
•
we face competition in the biopharmaceutical industry;
•
our revenues from sales of our products may decrease or grow at a slower than expected rate due to many factors;
•
revenues generated by sales of our products depend, in part, on the availability from third-party payers of reimbursement for our products and the
extent of cost-sharing arrangements for patients (e.g., patient co-payment, co-insurance, deductible obligations) and cost-control measures
imposed, and any reductions in payment rate or reimbursement or increases in our or in patients’ financial obligation to payers could result in
decreased sales of our products and/or decreased revenues;
•
if there are changes in, or we fail to comply with, the extensive legal and regulatory requirements affecting the healthcare industry, we could be
subject to investigations, litigation, costs, penalties and business losses;
•
we rely heavily on our licensees in the commercialization and continued development of products from which we receive revenue and, if our
licensees are not effective, or if disputes arise in respect of our contractual arrangements, our revenues could be materially adversely affected;
•
clinical trials for our product candidates are expensive, may take several years to complete, and their outcomes are uncertain;
•
preliminary, topline or interim data from our clinical trials that we may announce, publish or report from time to time may change as more
patient data become available or based on subsequent audit and verification procedures, and may not be indicative of final data from such trials,
data from future trials or real-world results;
•
our success depends, in part, on our ability to successfully obtain and maintain regulatory approval for our products;
•
disruptions at the United States (“U.S.”) Food and Drug Administration (the “FDA”), the U.S. Securities and Exchange Commission (“SEC”)
and other government agencies could negatively impact our business;
•
we may not be able to successfully expand our research and development (“R&D”) pipeline or our commercial product portfolio, which could
limit our growth potential;
•
we are subject to risks related to the manufacture of our products;
•
we rely on third parties to provide goods and services in connection with the manufacture and distribution of the products we manufacture;
•
our success largely depends upon our ability to attract, recognize and retain key personnel, and the loss of key personnel may materially and
adversely impact our business;
•
patent and other IP protection for our products is key to our business and our competitive position but is uncertain;
•
uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we or our licensees may
face claims against IP rights covering our products and competition from generic drug manufacturers;
•
litigation or arbitration filed against us, including securities litigation, or actions (such as citizens petitions) filed against regulatory agencies in
respect of our products, may result in financial losses, harm our reputation, divert management resources, negatively impact the approval of our
products, or otherwise negatively impact our business;
•
we may not be able to maintain profitability on a sustained basis;
•
the U.S. Internal Revenue Service (“IRS”) may not agree with our conclusion that we should be treated as a foreign corporation for U.S. federal
income tax purposes;
•
if the separation of our oncology business completed in November 2023 does not ultimately qualify as a transaction that is generally tax-free for
U.S. federal and Irish tax purposes as we anticipate, we and/or our shareholders could be subject to significant tax liabilities;
5
•
the market price of our ordinary shares has been volatile and may continue to be volatile in the future, and could decline significantly;
•
our business could be negatively affected as a result of the actions of activist shareholders; and
•
information security breaches and other disruptions could compromise our information and expose us to liability, which could cause our business
and reputation to suffer.
The material and other risks and uncertainties summarized above should be read together with the text of the full risk factors in “Item 1A—Risk
Factors” in this Annual Report and the other information set forth in this Annual Report, including our consolidated financial statements and the related
notes, and in other documents that we file with the SEC. If any such material or other risks and uncertainties actually occur, our business, financial
condition, cash flows or results of operations could be materially and adversely affected. The risks and uncertainties summarized above or described below
are not the only risks and uncertainties that we face. Additional risks and uncertainties not currently known to us, or that we currently deem to be
immaterial may also materially adversely affect our business, financial condition, cash flows or results of operations.
NOTE REGARDING COMPANY AND PRODUCT REFERENCES
Use of terms such as “us,” “we,” “our,” “Alkermes” or the “Company” in this Annual Report is meant to refer to Alkermes plc and its consolidated
subsidiaries. Except as otherwise suggested by the context, (a) references to “products” or “our products” in this Annual Report include our marketed
products, marketed products using our proprietary technologies, our licensed products, our product candidates and product candidates using our proprietary
technologies, (b) references to the “biopharmaceutical industry” in this Annual Report are intended to include reference to the “biotechnology industry”
and/or the “pharmaceutical industry” and (c) references to “licensees” in this Annual Report are used interchangeably with references to “partners.”
NOTE REGARDING TRADEMARKS
We are the owner of various U.S. federal trademark registrations (“®”) and other trademarks (“TM”), including ALKERMES®, ARISTADA®,
ARISTADA INITIO®, LinkeRx®, LYBALVI®, NanoCrystal®, and VIVITROL®.
The following are trademarks of the respective companies listed: ABILIFY®, ABILIFY ASIMTUFII® and ABILIFY MAINTENA®—Otsuka
Pharmaceutical Co., Ltd. (“Otsuka Pharm. Co.”); AMPYRA®—Acorda Therapeutics, Inc. (“Acorda”); ANJESO®—Baudax Bio, Inc.; ANTABUSE®—
Teva Women’s Health, Inc.; AUBAGIO® and LEMTRADA®—Sanofi Societe Anonyme France; AVONEX®, PLEGRIDY®, TECFIDERA®, TYSABRI®
and VUMERITY®—Biogen MA Inc. (together with its affiliates, “Biogen”); BETASERON®—Bayer Pharma AG; BRIXADI®—Braeburn Inc.;
BRIUMVI®—TG Therapeutics, Inc.; BUNAVAILTM—BioDelivery Sciences; CAMPRAL®—Merck Sante; CAPLYTA®—Intra-Cellular Therapies, Inc.;
COPAXONE® and UZEDY®—Teva Pharmaceutical Industries Ltd. (together with its affiliates, “Teva”) ; EXTAVIA®, GILENYA®, and MAYZENT®—
Novartis AG; BYANNLI®, CABENUVA®, INVEGA®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, PONVORY®,
RISPERDAL CONSTA®, TREVICTA® and XEPLION®—Johnson & Johnson or its affiliated companies; FAMPYRATM—Merz Pharmaceuticals, LLC;
MAVENCLAD®—Merck KGaA, REBIF®—Ares Trading S.A.; OCREVUS®—Genentech, Inc. (“Genentech”); REXULTI®—H. Lundbeck A/S plc;
PERSERIS®, SUBOXONE®, SUBUTEX® and SUBLOCADE®—Indivior plc (or its affiliates); RYKINDO®—Luye Pharma Group; VRAYLAR®— Forest
Laboratories, LLC; COBENFY® and ZEPOSIA®—Bristol-Myers Squibb Company; ZUBSOLV®—Orexo US, Inc.; and ZYPREXA® and ZYPREXA
RELPREVV®—Eli Lilly and Company (“Lilly”). Other trademarks, trade names and service marks appearing in this Annual Report are the property of
their respective owners. Solely for convenience, the trademarks and trade names in this Annual Report are referred to without the ® or ™ symbols, but such
references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights
thereto.
6
PART I
Item 1. Business
The following discussion contains forward-looking statements. Actual results may differ significantly from those expressed or implied in the
forward-looking statements. See “Cautionary Note Concerning Forward-Looking Statements” on page 3 of this Annual Report. Factors that might cause
future results to differ materially from those expressed or implied in the forward-looking statements include, but are not limited to, those discussed in “Item
1A—Risk Factors” and elsewhere in this Annual Report.
Overview
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. We have 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, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland,
we also have a corporate office and R&D center in Massachusetts and a manufacturing facility in Ohio.
Marketed Products
The key marketed products discussed below have generated, or are expected to generate, significant revenues for us. See the section entitled
“Patents and Proprietary Rights” in “Item 1—Business” in this Annual Report for information with respect to the IP protection for these marketed
products.
The following provides summary information regarding our proprietary products that we commercialize:
Proprietary Products
Product
Indication(s)
Territory
Initiation or re-initiation of
ARISTADA for the treatment of
Schizophrenia
U.S.
Schizophrenia
U.S.
7
Schizophrenia;
Bipolar I disorder
U.S.
Alcohol dependence;
Opioid dependence
U.S.
8
The following provides summary information regarding certain key third-party products using our proprietary technologies under license and our
key licensed product, that are commercialized by our licensees:
Key Third-Party Products Using Our Proprietary Technologies
Product
Indication(s)
Licensee
Licensed Territory
RISPERDAL CONSTA
Schizophrenia;
Bipolar I disorder
Janssen
Pharmaceuticals, Inc. and
Janssen Pharmaceutica
International, a division of
Cilag International AG
(“Janssen International”)
Worldwide
INVEGA SUSTENNA / XEPLION
INVEGA SUSTENNA:
Schizophrenia;
Schizoaffective disorder
XEPLION:
Schizophrenia
Janssen Pharmaceutica N.V.
(together with Janssen
Pharmaceuticals, Inc.,
Janssen International and
their affiliates “Janssen”)
Worldwide
INVEGA TRINZA / TREVICTA
Schizophrenia
Janssen
Worldwide
INVEGA HAFYERA / BYANNLI
Schizophrenia
Janssen
Worldwide
Our Key Licensed Product
Product
Indication(s)
Licensee
Licensed Territory
VUMERITY
Multiple sclerosis
Biogen
Worldwide
Proprietary Products
We have developed and now commercialize products designed to help address the unmet needs of people living with opioid dependence, alcohol
dependence, schizophrenia and bipolar I disorder. See the section entitled “Patents and Proprietary Rights” in “Item 1—Business” in this Annual Report
for information with respect to the IP protection for our proprietary products.
ARISTADA and ARISTADA INITIO
ARISTADA (aripiprazole lauroxil) is an extended-release intramuscular injectable suspension approved in the U.S. for the treatment of
schizophrenia. ARISTADA utilizes our proprietary LinkeRx technology. ARISTADA is a prodrug; once in the body, ARISTADA is likely converted by
enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. ARISTADA is available in four dose strengths
with once-monthly dosing options (441 mg, 662 mg and 882 mg), a six-week dosing option (882 mg) and a two-month dosing option (1064 mg).
ARISTADA is packaged in a ready-to-use, pre-filled syringe product format. We exclusively manufacture and commercialize ARISTADA in the U.S.
ARISTADA INITIO (aripiprazole lauroxil) leverages our proprietary LinkeRx and NanoCrystal technologies and provides an extended-release
formulation of aripiprazole lauroxil in a smaller particle size compared to ARISTADA, thereby enabling faster dissolution and more rapid achievement of
relevant levels of aripiprazole in the body. ARISTADA INITIO, combined with a single 30 mg dose of oral aripiprazole, is indicated for the initiation of
ARISTADA when used for the treatment of schizophrenia in adults. The first ARISTADA dose may be administered on the same day as the ARISTADA
INITIO regimen or up to 10 days thereafter. We exclusively manufacture and commercialize ARISTADA INITIO in the U.S.
9
In December 2024, U.S. Patent No. 12,180,164 relating to ARISTADA and ARISTADA INITIO was granted. The patent has claims to the
metabolite N-hydroxymethyl aripiprazole and expires in 2030.
What is schizophrenia?
Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and
agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal). Schizophrenia affects approximately 1.1%
of the U.S. population.
LYBALVI
LYBALVI (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug approved in the U.S. for the treatment of adults with
schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes,
as monotherapy or an adjunct to lithium or valproate. LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid
antagonist, in a single bilayer tablet. LYBALVI is available in fixed dosage strengths composed of 10 mg of samidorphan and 5 mg, 10 mg, 15 mg or 20
mg of olanzapine. We exclusively manufacture and commercialize LYBALVI in the U.S.
In January 2025, U.S. Patent No. 12,194,035 relating to LYBALVI was granted. The patent has claims to methods of treatment that cover
LYBALVI and expires in 2031.
What is schizophrenia?
See the disease state description in the section entitled “ARISTADA and ARISTADA INITIO” in “Item 1—Business” in this Annual Report.
What is bipolar I disorder?
Bipolar disorder is a brain disorder that is marked by extreme changes in a person’s mood, energy and ability to function. Individuals with this brain
disorder may experience debilitating mood states, including extreme highs (mania) and extreme lows (depression). Bipolar I disorder is characterized by
the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately 1% of the adult
population in the U.S. in any given year.
VIVITROL
VIVITROL (naltrexone for extended-release injectable suspension) is a once-monthly, non-narcotic, injectable medication approved in the U.S. for
the treatment of alcohol dependence in patients able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL and for
the prevention of relapse to opioid dependence, following opioid detoxification. VIVITROL uses our polymer-based microsphere injectable extended-
release technology to deliver and maintain therapeutic medication levels in the body through one intramuscular injection every four weeks. We exclusively
manufacture and commercialize VIVITROL in the U.S.
What are opioid dependence and alcohol dependence?
Opioid dependence is a serious and chronic brain disease characterized by compulsive, prolonged self-administration of opioid substances that are
not used for a medical purpose. According to the 2023 U.S. National Survey on Drug Use and Health, an estimated 5.4 million people aged 18 or older in
the U.S. had an opioid use disorder* in the prior year. Alcohol dependence is a serious and chronic brain disease characterized by cravings for alcohol, loss
of control over drinking, withdrawal symptoms and an increased tolerance for alcohol. According to the 2023 U.S. National Survey on Drug Use and
Health, an estimated 28.1 million people aged 18 or older in the U.S. had an alcohol use disorder* in the prior year. Adherence to medication is particularly
challenging with these disease states.
*
In 2013, with the publication of the Diagnostic Statistical Manual (“DSM”) 5, the DSM-IV diagnoses of substance use disorders as either dependence or abuse (i.e., opioid
dependence or alcohol dependence), which reflects the approved indications of VIVITROL, were subsumed under a new diagnostic category of “substance use disorders” (i.e.,
opioid use disorder or alcohol use disorder) with three categories of disorder severity—mild, moderate or severe. In determining the applicability of treatments for DSM-IV
conditions to persons diagnosed according to DSM-5, one study found agreement between the DSM-IV diagnoses of alcohol dependence and opioid dependence and moderate to
severe alcohol use disorder and opioid use disorder, respectively, under DSM-5.
10
Licensed Products and Products Using Our Proprietary Technologies
We have licensed products to third parties for commercialization and have licensed our proprietary technologies to third parties to enable them to
develop, commercialize and/or manufacture products. See the section entitled “Proprietary Technology Platforms” and “Patents and Proprietary Rights” in
“Item 1—Business” in this Annual Report for information with respect to our proprietary technologies and the IP protection for these products. We receive
royalties and/or manufacturing and other revenues from the commercialization of these products under our collaborative arrangements with these third
parties. Such arrangements include, among others, the following:
Products Using Our Proprietary Technologies
INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI
INVEGA SUSTENNA/XEPLION (paliperidone palmitate), INVEGA TRINZA/TREVICTA (paliperidone palmitate) and INVEGA
HAFYERA/BYANNLI (paliperidone palmitate) (collectively, the “long-acting INVEGA products”) are long-acting atypical antipsychotics owned and
commercialized worldwide by Janssen. We believe that these products incorporate our technologies.
INVEGA SUSTENNA is approved in the U.S. for the treatment of schizophrenia and for the treatment of schizoaffective disorder as either a
monotherapy or adjunctive therapy. Paliperidone palmitate extended-release injectable suspension is approved in the European Union (“EU”) and other
countries outside of the U.S. for the treatment of schizophrenia and is marketed and sold under the trade name XEPLION. INVEGA
SUSTENNA/XEPLION is manufactured by Janssen.
INVEGA TRINZA is approved in the U.S. for the treatment of schizophrenia in patients who have been adequately treated with INVEGA
SUSTENNA for at least four months. TREVICTA is approved in the EU for the maintenance treatment of schizophrenia in adult patients who are clinically
stable on XEPLION. INVEGA TRINZA/TREVICTA is manufactured by Janssen.
INVEGA HAFYERA is approved in the U.S. for the treatment of schizophrenia in patients who have been adequately treated with INVEGA
SUSTENNA for at least four months or INVEGA TRINZA for at least three months. BYANNLI is approved in the EU for the maintenance treatment of
schizophrenia in adult patients who are clinically stable on XEPLION or TREVICTA. INVEGA HAFYERA/BYANNLI is manufactured by Janssen.
For a discussion of legal proceedings related to certain of the patents covering INVEGA TRINZA, see Note 19, Commitments and Contingent
Liabilities in the “Notes to Consolidated Financial Statements” in this Annual Report and for information about risks relating to such legal proceedings, see
“Item 1A—Risk Factors” in this Annual Report and specifically the section entitled “Uncertainty over IP in the biopharmaceutical industry has been the
source of litigation and other legal proceedings, and we or our licensees may face claims against IP rights covering our products and competition from
generic drug manufacturers.”
What is schizophrenia?
See the disease state description in the section entitled “ARISTADA and ARISTADA INITIO” in “Item 1—Business” in this Annual Report.
What is schizoaffective disorder?
Schizoaffective disorder is a condition in which a person experiences a combination of schizophrenia symptoms, such as delusions, hallucinations or
other symptoms characteristic of schizophrenia, and mood disorder symptoms, such as mania or depression. Schizoaffective disorder is a serious mental
illness that affects about one in 300 people.
RISPERDAL CONSTA
RISPERDAL CONSTA (risperidone long-acting injection) is a long-acting atypical antipsychotic owned and commercialized worldwide by Janssen
that incorporates our proprietary technologies. RISPERDAL CONSTA is approved in the U.S. for the treatment of schizophrenia and as both monotherapy
and adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder. RISPERDAL CONSTA is approved in numerous
countries outside of the U.S. for the treatment of schizophrenia and the maintenance treatment of bipolar I disorder. RISPERDAL CONSTA uses our
polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through just one
intramuscular injection every two weeks. RISPERDAL CONSTA microspheres are exclusively manufactured by us.
What is schizophrenia?
See the disease state description in the section entitled “ARISTADA and ARISTADA INITIO” in “Item 1—Business” in this Annual Report.
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Licensed Product
VUMERITY
VUMERITY (diroximel fumarate) is a novel, oral fumarate with a distinct chemical structure that is approved in the U.S., the EU and several other
countries for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease and active
secondary progressive disease.
Under our license and collaboration agreement with Biogen, Biogen holds the exclusive, worldwide license to develop and commercialize
VUMERITY. For more information about the license and collaboration agreement with Biogen, see the section entitled “Collaborative Arrangements—
Biogen” in “Item 1—Business” in this Annual Report. For a discussion of legal proceedings related to certain of the patents covering VUMERITY, see
Note 19, Commitments and Contingent Liabilities in the “Notes to Consolidated Financial Statements” in this Annual Report and for information about
risks relating to such legal proceedings, see “Item 1A—Risk Factors” in this Annual Report and specifically the section entitled “Uncertainty over IP in the
biopharmaceutical industry has been the source of litigation and other legal proceedings, and we or our licensees may face claims against IP rights covering
our products and competition from generic drug manufacturers.”
What is multiple sclerosis?
Multiple sclerosis (“MS”) is an unpredictable, often disabling disease of the central nervous system (“CNS”), which interrupts the flow of
information within the brain, and between the brain and body. MS symptoms can vary over time and from person to person. Symptoms may include
extreme fatigue, impaired vision, problems with balance and walking, numbness or pain and other sensory changes, bladder and bowel symptoms, tremors,
problems with memory and concentration and mood changes, among others. Approximately 2.5 million people worldwide have MS, and most are
diagnosed between the ages of 15 and 50.
Key Development Program
Our R&D is focused on the development of innovative medicines in the field of neuroscience that are designed to address unmet patient needs. As
part of our ongoing R&D efforts, we have devoted, and will continue to devote, significant resources to conducting preclinical work and clinical studies to
advance the development of new pharmaceutical products. The discussion below highlights our current key development program. Drug development
involves a high degree of risk and investment, and the status, timing and scope of our development programs are subject to change. Important factors that
could adversely affect our drug development efforts are discussed in “Item 1A—Risk Factors” in this Annual Report. See the section entitled “Patents and
Proprietary Rights” in “Item 1—Business” in this Annual Report for information with respect to the IP protection for our key development program.
ALKS 2680
ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor agonist in development as a once-daily treatment for narcolepsy type 1,
narcolepsy type 2 and idiopathic hypersomnia. Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of
wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain. Targeting the orexin system
may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease.
Once-daily oral administration of ALKS 2680 was previously evaluated in a phase 1 study in healthy volunteers and patients with narcolepsy type 1,
narcolepsy type 2 and idiopathic hypersomnia and is currently being evaluated in two phase 2 studies: Vibrance-1 in patients with narcolepsy type 1 and
Vibrance-2 in patients with narcolepsy type 2. We expect to initiate Vibrance-3, a phase 2 study in patients with idiopathic hypersomnia, in the first half of
2025.
Collaborative Arrangements
We have entered into several collaborative arrangements to develop and commercialize products and, in connection with such arrangements, to
access or provide access to, technological, financial, marketing, manufacturing and other resources, including the arrangements described below.
Janssen
INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI
Under an exclusive license agreement with Janssen, we provided Janssen with rights to, and know-how, training and technical assistance in respect
of, our small particle pharmaceutical compound technology, known as NanoCrystal technology, which was used to develop the long-acting INVEGA
products, and we received milestone payments from Janssen upon the achievement of certain development goals. There are no further milestones to be
earned under this agreement. The agreement also provides for royalty
12
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 with valid claims applicable to the product in such
country. The know-how royalty is a tiered royalty of 3.5% on calendar year net sales up to $250 million; 5.5% on calendar year net sales of between $250
million and $500 million; and 7.5% on calendar year net sales exceeding $500 million. The know-how royalty rate resets to 3.5% at the beginning of each
calendar year and is payable until 15 years from the 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 us. We 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. In
November 2021, we received notice from Janssen of partial termination of the license agreement, following which Janssen ceased paying us royalties
related to U.S. sales of INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA. In April 2022, we 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”) 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 we were 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, we collaborated with Janssen on the development of RISPERDAL CONSTA. Under the development
agreement, Janssen provided funding to us for the development of RISPERDAL CONSTA, and Janssen is responsible for securing all necessary regulatory
approvals for the product.
Under two license agreements, we granted Janssen and an affiliate of Janssen exclusive worldwide licenses to use and sell RISPERDAL CONSTA.
Under our license agreements with Janssen, we receive 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 us. 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 15-year minimum shall
pertain regardless. After expiration, Janssen retains a non-exclusive, royalty-free license to manufacture, use and sell RISPERDAL CONSTA.
We exclusively manufacture RISPERDAL CONSTA at our Wilmington, Ohio facility for commercial sale. Under our manufacturing and supply
agreement with Janssen, we receive manufacturing revenue 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 us. In the event that Janssen terminates the
manufacturing and supply agreement without terminating the license agreements, the royalty rate payable to us on Janssen’s net sales of RISPERDAL
CONSTA would increase from 2.5% to 5.0%.
Revenues from our collaborative arrangements with Janssen accounted for approximately 17%, 31% and 15% of our consolidated revenues for the
years ended December 31, 2024, 2023 and 2022, respectively.
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Biogen
Under a license and collaboration agreement with Biogen, we granted Biogen a worldwide, exclusive, sublicensable license to develop, manufacture
and commercialize VUMERITY and other products covered by patents licensed to Biogen under that agreement.
Under this license and collaboration agreement, we received an upfront cash payment and milestone payments related to the achievement of certain
milestones. We are 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, we receive a 15% royalty, subject to increases for VUMERITY manufactured and/or packaged by Biogen or its designees, on
worldwide net sales of VUMERITY. We are 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 are subject to customary reductions, as set forth in the license and collaboration agreement.
Following FDA approval of VUMERITY and except for the manufacturing responsibilities discussed below, Biogen is now responsible for all
development and commercialization activities for VUMERITY and all other products covered by the patents that we licensed to Biogen.
Under the license and collaboration agreement, Biogen appointed us 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. In October 2019, we entered into a
commercial supply agreement with Biogen for the commercial supply of VUMERITY, an amendment to such commercial supply agreement and an
amendment to the license and collaboration agreement with Biogen, pursuant to which Biogen has conducted a technology transfer and, following an
agreed manufacturing transition period, has elected to assume responsibility for the manufacture (itself or through a designee) of clinical and commercial
supplies of VUMERITY in exchange for an increase in the royalty rate to be paid by Biogen to us on net sales of product that is manufactured by Biogen or
its designee. In May 2024, we completed the sale of our research and development business and manufacturing facility in Athlone, Ireland (the “Athlone
Facility”) where VUMERITY is manufactured. In connection with the sale of the Athlone Facility, we have entered into a subcontracting arrangement with
the purchaser of the Athlone Facility for the manufacture of VUMERITY through the manufacturing transition period, which may continue through the end
of 2025.
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 us. 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 our request, the VUMERITY program will revert to us.
Revenues from Biogen related to this license and collaboration agreement accounted for approximately 9%, 8% and 10% of our consolidated
revenues for the years ended December 31, 2024, 2023 and 2022, respectively.
Proprietary Technology Platforms
We have used our proprietary technology platforms, which include technologies owned and exclusively licensed to us, to establish drug
development, clinical development and regulatory expertise and in the development of our products.
Injectable Extended-Release Microsphere Technology
Our injectable extended-release microsphere technology allows us to encapsulate small-molecule pharmaceuticals, peptides and proteins in
microspheres made of common medical polymers. The technology is designed to enable novel formulations of pharmaceuticals by providing controlled,
extended release of drugs over time. Drug release from the microsphere is controlled by diffusion of the drug through the microsphere and by
biodegradation of the polymer. These processes can be modulated through a number of formulation and fabrication variables, including drug substance and
microsphere particle sizing and choice of polymers and excipients.
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LinkeRx Technology
Our long-acting LinkeRx technology platform is designed to enable the creation of extended-release injectable versions of antipsychotic therapies
and may also be useful in other disease areas in which extended duration of action may provide therapeutic benefits. The technology uses proprietary
linker-tail chemistry to create new molecular entities derived from known agents.
NanoCrystal Technology
Our NanoCrystal technology is applicable to poorly water-soluble compounds and involves formulating and stabilizing drugs into particles that are
nanometers in size. A drug in NanoCrystal form can be incorporated into a range of common dosage forms, including tablets, capsules, inhalation devices
and sterile forms for injection, with the potential for enhanced oral bioavailability, increased therapeutic effectiveness, reduced/eliminated fed/fasted
variability and sustained duration of intravenous/intramuscular release.
Oral Controlled Release Technology
Our oral controlled release (“OCR”) technologies are used to formulate, develop and manufacture oral dosage forms of pharmaceutical products
with varied drug release profiles.
Manufacturing and Product Supply
We own and occupy a manufacturing facility in Wilmington, Ohio. We either purchase active pharmaceutical ingredient (“API”) from third parties
or receive it from our third-party licensees to manufacture products using our technologies. The manufacture of our products for clinical trials and
commercial use is subject to Current Good Manufacturing Practices (“cGMP”) regulations and other regulations. Our manufacturing and development
capabilities include formulation through process development, scale-up and full-scale commercial manufacturing and specialized capabilities for the
development and manufacture of controlled substances.
Although some materials and related services for our products are currently only available from a single source or a limited number of qualified
sources, we attempt to acquire an adequate inventory of such materials, establish alternative sources for such materials and related services and/or negotiate
long-term supply arrangements. However, we cannot be certain that we will continue to be able to obtain long-term supplies of our manufacturing materials
or long-term provision of related services.
Our supply chain includes an external network of third-party service providers involved in the manufacture of our products whose manufacturing
facilities and processes are, like ours, subject to inspection by the FDA or comparable agencies in other jurisdictions. Any delay, interruption or other
issues that arise in the acquisition of API, raw materials, or components, or in the manufacture, fill-finish, packaging, or storage of our marketed or
development products, including as a result of a failure of our facilities or the facilities or operations of third parties to pass any regulatory agency
inspection, could significantly impair our ability to manufacture and market our products or advance our development efforts, as the case may be.
In May 2024, we completed the sale of our Athlone Facility and related business to Novo Nordisk (“Novo”) and entered into subcontracting
arrangements to continue certain development and manufacturing activities performed at the Athlone Facility for a period of time after the closing of the
transaction, which may continue through the end of 2025. For information about risks relating to the manufacture of our marketed products and product
candidates, see “Item 1A—Risk Factors” in this Annual Report and specifically those sections entitled “We rely on third parties to provide goods and
services in connection with the manufacture and distribution of the products we manufacture” and “We are subject to risks related to the manufacture of our
products.”
Marketed Products
We manufacture ARISTADA, ARISTADA INITIO, LYBALVI, VIVITROL and microspheres for RISPERDAL CONSTA at our Wilmington,
Ohio facility. We outsource our packaging operations for ARISTADA, ARISTADA INITIO, LYBALVI and VIVITROL to third-party contractors. Janssen
is responsible for packaging operations for RISPERDAL CONSTA. Our Wilmington, Ohio facility has been inspected by U.S., European (including the
UK Medicines and Healthcare products Regulatory Agency), Chinese, Japanese, Brazilian, Turkish, Russian and Saudi Arabian regulatory authorities for
compliance with required cGMP standards for continued commercial manufacturing. For more information about our Wilmington, Ohio manufacturing
facility, see “Item 2—Properties” in this Annual Report.
We have entered into subcontracting arrangements for the manufacture of several products in the Athlone Facility that are marketed by third parties,
including VUMERITY. This facility has been inspected by regulatory authorities of numerous jurisdictions for compliance with required cGMP standards
for continued commercial manufacturing.
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Clinical Products
We manufacture clinical supplies of injectable extended-release products and solid dosage form products at our Wilmington, Ohio facility. We have
also contracted with third-party manufacturers to formulate certain products for clinical use. We require that our contract manufacturers adhere to cGMP in
the manufacture of our products or components of our products for clinical use.
Research & Development
We devote significant resources to R&D programs. We focus our R&D efforts on developing novel therapeutics in areas of high unmet medical
need. Our R&D efforts include, but are not limited to, areas such as pharmaceutical formulation, analytical chemistry, process development, engineering,
scale-up and drug optimization/delivery. Please see “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in
this Annual Report for additional information relating to our R&D expenditures.
Permits and Regulatory Approvals
We hold various permits, registrations, approvals and/or licenses in respect of our manufacturing and related activities. The primary licenses held in
this regard are FDA Registrations of Drug Establishment, and licenses from the Drug Enforcement Administration of the U.S. Department of Justice (the
“DEA”). We also hold various authorizations, licenses and certificates from the Health Products Regulatory Authority in Ireland, including an
Investigational Medicinal Products Manufacturers Authorization (No. IMP074/00002) and a Manufacturers Authorization (No. M13297/00001) in respect
of our offices located in Dublin, Ireland, and a Manufacturers Authorization (No. M13297/00002), in respect of the Athlone Facility, pending completion
of updates to applicable product filings. We also hold current GMP certificates associated with each of these authorizations. Due to certain U.S. state law
requirements, we also hold state licenses to cover distribution activities conducted in certain states where required. Additional Manufacturer Authorizations
that we previously held in respect of the Athlone Facility were transferred to Novo with the sale of the facility and related business in May 2024.
We do not generally act as the marketing authorization holder for products incorporating our technologies that have been developed on behalf of a
licensee of such technologies. In such cases, our licensee usually holds the relevant marketing authorization from the FDA or other relevant regulatory
authority, and we support this authorization as needed, including by furnishing a copy of the product’s Drug Master File, or chemistry, manufacturing and
controls data, to the relevant regulator. We generally update this information annually with the relevant regulator. In other cases where we have developed
proprietary products, such as VIVITROL, ARISTADA, ARISTADA INITIO and LYBALVI, we hold the marketing authorization and related regulatory
documentation ourselves.
Marketing, Sales and Distribution
We are responsible for the marketing of VIVITROL, ARISTADA, ARISTADA INITIO, and LYBALVI in the U.S. We focus our sales and
marketing efforts on physicians in private practice and in public treatment systems. We believe that we use customary pharmaceutical company practices to
market our products, including through advertisements, professional symposia, selling initiatives and other methods, and to educate individual physicians,
nurses, social workers, counselors and other stakeholders involved in the treatment of opioid dependence, alcohol dependence, schizophrenia and bipolar I
disorder. We provide, and contract with third-party vendors to provide, customer services and other related programs for our products, such as product-
specific websites, insurance research services and order, delivery and fulfillment services.
Our sales force for VIVITROL in the U.S. consisted of approximately 105 individuals as of December 31, 2024. VIVITROL is primarily sold to
pharmaceutical wholesalers, pharmacies, specialty distributors and treatment providers. Product sales of VIVITROL during the year ended December 31,
2024 to McKesson Corporation, Cardinal Health and Cencora, Inc. (formerly known as Amerisource Bergen, “Cencora”) represented approximately 34%,
21% and 16%, respectively, of total VIVITROL gross sales.
Our sales force for ARISTADA, ARISTADA INITIO and LYBALVI in the U.S. consisted of approximately 355 individuals as of December 31,
2024. ARISTADA, ARISTADA INITIO and LYBALVI are primarily sold to pharmaceutical wholesalers. Product sales of ARISTADA and ARISTADA
INITIO during the year ended December 31, 2024 to McKesson Corporation, Cardinal Health and Cencora represented approximately 38%, 32% and 23%,
respectively, of total ARISTADA and ARISTADA INITIO gross sales. Product sales of LYBALVI during the year ended December 31, 2024 to
McKesson Corporation, Cardinal Health and Cencora represented approximately 35%, 32% and 29%, respectively, of total LYBALVI gross sales.
ICS, a division of Cencora, provides warehousing, shipping and administrative services for VIVITROL, ARISTADA, ARISTADA INITIO and
LYBALVI.
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Under our license agreements with Janssen, Biogen and other licensees and sublicensees, the licensees and sublicensees are typically responsible for
the commercialization of any products developed under their respective agreements if and when regulatory approval is obtained.
Competition
We face intense competition in the development, manufacture, marketing and commercialization of our products from many and varied sources,
such as research institutions and biopharmaceutical companies, including other companies with similar technologies. Some of these competitors are also
our licensees, who control the commercialization of products from which we receive manufacturing and/or royalty revenues. In some cases, these
competitors may be working to develop and market other products, systems, or other methods of preventing or reducing disease, or new small-molecule or
other classes of drugs.
The biopharmaceutical industry is characterized by intensive research, development and commercialization efforts and rapid and significant
technological change. In many cases, there are already products on the market that may be in direct competition with our commercial products or products
in development. In addition, there are many companies developing products for use in similar indications or with similar technologies to ours with whom
we and our licensees compete, many of whom are larger and have significantly greater financial, operational and other resources than we do. Other smaller
or earlier stage companies may also prove to be significant competitors, whether through focused or more abbreviated development programs, or
collaborative arrangements with large, established companies. Some of the products being developed by our competitors are being designed to work
differently than our products and may prove to be safer or more effective than our products or achieve regulatory approval and be commercialized earlier
than our products, which may render our products or technology platforms obsolete or noncompetitive or make it more challenging for us to commercialize
our products. With respect to our products, we believe that our ability to successfully compete will depend on, among other things, the existence of
competing or alternative products in the marketplace, including generic competition, and the relative price of those products; the efficacy, safety and
reliability of our products compared to competing or alternative products; product acceptance by, and preferences of, physicians, other healthcare providers
and patients; our ability to comply with applicable laws, regulations and regulatory requirements with respect to the manufacture and/or commercialization
of our products, including any changes or increases to regulatory restrictions; protection of our proprietary rights relating to our products; our ability to
obtain reimbursement for our products; our ability to complete clinical development and obtain regulatory approvals for our products, and the timing and
scope of any such regulatory approvals; our ability to successfully manufacture and provide a reliable supply of commercial quantities of a product to the
market; and our ability to recruit, retain and develop skilled employees.
With respect to our proprietary injectable product platform, we are aware that there are other companies developing extended-release delivery
systems for pharmaceutical products, including but not limited to technology from Pharmathen S.A., which underpins aripiprazole formulations in
development, and technology underpinning Teva’s once every two weeks injectable microsphere formulation, each for the treatment of schizophrenia. In
the treatment of schizophrenia, ARISTADA, the long-acting INVEGA products and RISPERDAL CONSTA compete with each other and a number of
other injectable products, including ZYPREXA RELPREVV ((olanzapine) For Extended Release Injectable Suspension), which is marketed and sold by
Lilly; ABILIFY MAINTENA (aripiprazole for extended release injectable suspension), a once-monthly injectable formulation of ABILIFY (aripiprazole)
developed by Otsuka Pharm. Co.; ABILIFY ASIMTUFII (aripiprazole), a once-every-two-months injectable formulation of ABILIFY (aripiprazole)
developed by Otsuka Pharm. Co.; PERSERIS (risperidone for extended release injectable suspension), a once-monthly formulation of risperidone marketed
by Indivior plc; RYKINDO (risperidone), a once-every-two-weeks injectable formulation of risperidone developed by Luye Pharma Group; UZEDY
(risperidone) extended-release injectable suspension, for subcutaneous use, developed and marketed by MedinCell S.A. and Teva; and generic versions of
branded injectable products.
In the treatment of schizophrenia, LYBALVI competes with other oral antipsychotic products, including CAPLYTA (lumateperone) developed and
marketed by Intra-Cellular Therapies, Inc.; REXULTI (brexpiprazole), which is co-marketed by Otsuka Pharm Co. and H. Lundbeck A/S plc; VRAYLAR
(cariprazine), which is marketed and sold by Abbvie Inc.; COBENFY (xanomeline and trospium chloride), which is marketed and sold by Bristol-Myers
Squibb Company; other oral compounds currently on the market; and generic versions of branded oral products. Other pharmaceutical companies are
developing products for the treatment of schizophrenia that, if approved by the FDA, would compete with LYBALVI.
In the treatment of bipolar I disorder, LYBALVI and RISPERDAL CONSTA compete with antipsychotics such as oral aripiprazole; VRAYLAR;
ABILIFY MAINTENA; ABILIFY ASIMTUFII; CAPLYTA; RYKINDO; risperidone; quetiapine; olanzapine; and ziprasidone. Other pharmaceutical
companies are developing products for the treatment of bipolar I disorder that, if approved by the FDA, would compete with LYBALVI.
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In the treatment of alcohol dependence, VIVITROL competes with generic acamprosate calcium (also known as CAMPRAL) and generic
disulfiram (also known as ANTABUSE) as well as currently marketed drugs, including generic drugs, also formulated from naltrexone. Other
pharmaceutical companies are developing products that have shown some potential in treating alcohol dependence that, if approved by the FDA, would
compete with VIVITROL.
In the treatment of opioid dependence, VIVITROL competes with SUBOXONE (buprenorphine HCl/naloxone HCl dehydrate sublingual tablets),
SUBOXONE (buprenorphine/naloxone) Sublingual Film, SUBUTEX (buprenorphine HCl sublingual tablets) and SUBLOCADE (once-monthly
buprenorphine extended-release injection), each of which is marketed and sold by Indivior plc; BUNAVAIL buccal film (buprenorphine and naloxone)
marketed by BioDelivery Sciences; ZUBSOLV (buprenorphine and naloxone) marketed by Orexo US, Inc.; and BRIXADI (buprenorphine) extended-
release injection for subcutaneous use (CIII), marketed by Braeburn Inc. VIVITROL also competes with methadone, oral naltrexone and generic versions
of SUBUTEX and SUBOXONE sublingual tablets. Other pharmaceutical companies are developing products that have shown potential in treating opioid
dependence that, if approved by the FDA, would compete with VIVITROL.
In the treatment of MS, VUMERITY competes with AVONEX (interferon beta-1a), TYSABRI (natalizumab), TECFIDERA (dimethyl fumarate),
and PLEGRIDY (peginterferon beta-1a) from Biogen; OCREVUS (ocrelizumab) from Genentech; BETASERON (interferon beta-1b) from Bayer
HealthCare Pharmaceuticals; COPAXONE (glatiramer acetate) from Teva; REBIF (interferon beta-1a) and MAVENCLAD (cladribine) from EMD
Serono, Inc.; GILENYA (fingolimod), EXTAVIA (interferon beta-1b) and MAYZENT (siponimod) from Novartis AG; AUBAGIO (teriflunomide) and
LEMTRADA (alemtuzumab) from Sanofi-Aventis; ZEPOSIA (ozanimod) from Bristol-Myers Squibb Company; PONVORY (ponesimod) from Janssen;
and BRIUMVI (ublituximab-xiiy) from TG Therapeutics, Inc.
With respect to our NanoCrystal technology, we are aware that other technology approaches similarly address poorly water-soluble drugs. These
approaches include nanoparticles, cyclodextrins, lipid-based self-emulsifying drug delivery systems, dendrimers and micelles, among others, any of which
could limit the potential success and growth prospects of products incorporating our NanoCrystal technology. In addition, there are many competing
technologies to our OCR technology, some of which are owned by large pharmaceutical companies with drug delivery divisions or other, smaller drug-
delivery-specific companies.
Patents and Proprietary Rights
Our success depends, in part, on our ability to obtain and maintain patent protection for our products, including those marketed and sold by our
licensees, to maintain trade secret protection and to operate without infringing upon the proprietary rights of others. We have a proprietary portfolio of
patent rights and exclusive licenses to patents and patent applications, which includes numerous patents in the U.S. and in other countries directed to
compositions of matter, methods of treatment and formulations, and processes of preparation. In the future, we plan to file additional patent applications in
the U.S. and in other countries directed to new or improved products and processes, and we intend to continue to vigorously defend our patent positions. In
addition, our licensees may own additional patents that cover those products from which we receive royalties.
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ARISTADA and ARISTADA INITIO
We have several U.S. patents and patent applications, and a number of corresponding non-U.S. counterparts, that cover ARISTADA and/or
ARISTADA INITIO. Our principal U.S. patents for ARISTADA and/or ARISTADA INITIO and their expiration dates are as follows:
U.S. Patent No.
Product(s) Covered
Expiration Date
8,431,576
ARISTADA;
ARISTADA INITIO
2030
8,796,276
ARISTADA;
ARISTADA INITIO
2030
10,112,903
ARISTADA;
ARISTADA INITIO
2030
10,023,537
ARISTADA
2030
10,351,529
ARISTADA;
ARISTADA INITIO
2030
11,518,745
ARISTADA;
ARISTADA INITIO
2030
12,180,164
ARISTADA;
ARISTADA INITIO
2030
11,273,158
ARISTADA;
ARISTADA INITIO
2039
9,034,867
ARISTADA
2032
10,226,458
ARISTADA
2032
9,193,685
ARISTADA
2033
9,861,699
ARISTADA
2033
10,342,877
ARISTADA
2033
10,639,376
ARISTADA
2033
11,097,006
ARISTADA
2033
11,969,469
ARISTADA
2033
9,452,131
ARISTADA
2035
9,526,726
ARISTADA
2035
10,064,859
ARISTADA
2035
10,238,651
ARISTADA
2035
10,478,434
ARISTADA
2035
10,813,928
ARISTADA
2035
10,973,816
ARISTADA
2035
11,406,632
ARISTADA
2035
11,883,394
ARISTADA
2035
10,016,415
ARISTADA INITIO
2035
10,688,091
ARISTADA INITIO
2035
10,849,894
ARISTADA INITIO
2035
11,115,552
ARISTADA INITIO
2035
VIVITROL
We have a number of patents and pending patent applications covering our microsphere technology throughout the world, which, to some extent,
cover VIVITROL.
We own one unexpired Orange-Book listed U.S. patent covering VIVITROL, which expires in the U.S. in 2029. Pursuant to the terms of a
confidential settlement and license agreement entered into in August 2023 with Teva, we granted Teva a non-exclusive, royalty-free, non-transferable, non-
sublicensable limited license under the remaining patent covering VIVITROL to market and sell a generic version of VIVITROL in the U.S. beginning on
January 15, 2027 (the “First Entry Date”), or earlier under certain circumstances. Under the terms of a settlement and license agreement entered into in July
2019 with Amneal Pharmaceuticals LLC (“Amneal”), we granted Amneal a non-exclusive license under certain patents covering VIVITROL, including the
remaining patent covering VIVITROL in the U.S., to market and sell a generic formulation of VIVITROL in the U.S. beginning on the earlier of the First
Entry Date, sometime in 2028 or earlier under certain circumstances.
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INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI
Our NanoCrystal technology patent portfolio, licensed to Janssen, contains a number of granted patents and pending patent applications throughout
the world, including in the U.S. and in countries outside of the U.S. The latest to expire of the patents subject to our license agreement expires in 2030 in
the U.S., the EU and certain other countries. In addition, Janssen has other patents not subject to our license agreement, including, among others, one that
covers INVEGA TRINZA in the U.S. and expires in 2036 and two that cover INVEGA HAFYERA in the U.S. and expire in 2041. For a discussion of
legal proceedings related to patents covering INVEGA TRINZA, see Note 19, Commitments and Contingent Liabilities in the “Notes to Consolidated
Financial Statements” in this Annual Report.
VUMERITY
We have U.S. patents and patent applications, and a number of corresponding non-U.S. counterparts, that cover VUMERITY. U.S. Patent Nos.
8,669,281, 9,090,558 and 10,080,733, each expiring in 2033, cover compositions of, or methods of treatment for, VUMERITY. For a discussion of legal
proceedings related to patents covering VUMERITY, see Note 19, Commitments and Contingent Liabilities in the “Notes to Consolidated Financial
Statements” in this Annual Report.
LYBALVI
We own or have a license to U.S. and worldwide patents and patent applications that cover a class of compounds that includes the opioid modulators
in LYBALVI. In addition, we own U.S. and worldwide patents and patent applications that claim formulations and methods of treatment that cover
LYBALVI. The principal owned or licensed U.S. patents for LYBALVI and their expiration dates are as follows:
U.S. Patent No.
Product Covered
Expiration Date
7,262,298
LYBALVI
2025
8,680,112
LYBALVI
2030
9,119,848
LYBALVI
2031
10,005,790
LYBALVI
2031
9,126,977
LYBALVI
2031
9,517,235
LYBALVI
2031
9,943,514
LYBALVI
2031
10,300,054
LYBALVI
2031
10,716,785
LYBALVI
2031
11,185,541
LYBALVI
2031
11,241,425
LYBALVI
2031
11,351,166
LYBALVI
2031
11,793,805
LYBALVI
2031
12,194,035
LYBALVI
2031
8,778,960
LYBALVI
2032
11,707,466
LYBALVI
2041
11,951,111
LYBALVI
2041
ALKS 2680
We have U.S. patent protection that extends to 2041, several U.S. patent applications, and a number of corresponding non-U.S. counterparts, that
cover ALKS 2680.
Protection of Proprietary Rights and Competitive Position
We have exclusive rights through licensing agreements with third parties to issued U.S. patents, pending patent applications and corresponding
patents or patent applications in countries outside the U.S, subject in certain instances to the rights of the U.S. government to use the technology covered by
such patents and patent applications. Under certain licensing agreements, we are responsible for patent expenses, and we pay annual license fees and/or
minimum annual royalties. In addition, under these licensing agreements, we are typically obligated to pay royalties on future sales of products, if any,
covered by the licensed patents.
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There may be patents issued to third parties that relate to our products or technologies. The manufacture, use, offer for sale, sale or import of some
of our products might be found to infringe on the claims of these patents. A third party might file an infringement action against us. The cost of defending
such an action is likely to be high, and we might not receive a favorable ruling. There may also be patent applications filed by third parties that relate to
some of our products if issued in their present form. The patent laws of the U.S. and other countries are distinct, and decisions as to patenting, validity of
patents and infringement of patents may be resolved differently in different countries.
If patents exist or are issued that cover our products or technologies, we or our licensees may not be able to manufacture, use, offer for sale, sell or
import some of our products without first getting a license from the patent holder. The patent holder may not grant us a license on reasonable terms, or it
may refuse to grant us a license at all. This could delay or prevent us from developing, manufacturing, selling or importing those of our products that would
require the license.
We try to protect our proprietary position by filing patent applications in the U.S. and in other countries related to our proprietary technologies,
inventions and improvements that are important to the development of our business. Because the patent position of biopharmaceutical companies involves
complex legal and factual questions, enforceability of patents cannot be predicted with certainty. The ultimate degree of patent protection that will be
afforded to products and processes, including ours, in the U.S. and in other important markets, remains uncertain and is dependent upon the scope of
protection decided upon by the patent offices, courts and lawmakers in these countries. Patents, if issued, may be challenged, invalidated or circumvented.
Thus, any patents that we own or license from others may not provide any protection against competitors. Our pending patent applications, those we may
file in the future, or those we may license from third parties, may not result in patents being issued. If issued, such patents may not provide us with
proprietary protection or competitive advantages against competitors with similar technology. Furthermore, others may independently develop similar
technologies or duplicate any technology that we have developed outside the scope of our patents. The laws of certain countries do not protect our IP rights
to the same extent as the laws of the U.S.
We also rely on trade secrets, know-how and inventions, which are not protected by patents, to maintain our competitive position. We try to protect
this information by entering into confidentiality agreements with parties that have access to such information, such as our corporate partners, collaborators,
licensees, employees and consultants. However, any of these parties may breach such agreements and may disclose our confidential information or our
competitors might learn of the information in some other way. If any trade secret, know-how or other invention not protected by a patent were to be
disclosed to, or independently developed by, a competitor, such event could materially adversely affect our business, financial condition, cash flows and
results of operations. For more information, see “Item 1A—Risk Factors” in this Annual Report.
Our trademarks, including VIVITROL, ARISTADA, ARISTADA INITIO and LYBALVI, are important to us and are generally covered by
trademark applications or registrations with the U.S. Patent and Trademark Office (the “USPTO”) and the patent or trademark offices of other countries.
Our licensed products and products using our proprietary technologies also use trademarks that are owned by our licensees, such as the trademarks for
INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA, INVEGA HAFYERA/BYANNLI and RISPERDAL CONSTA, which are registered
trademarks of Johnson & Johnson or its affiliated companies and VUMERITY, which is a registered trademark of Biogen (and used by us under license).
Trademark protection varies in accordance with local law and continues in some countries as long as the trademark is used and in other countries as long as
the trademark is registered. Trademark registrations generally are for fixed but renewable terms.
Regulatory
Regulation of Pharmaceutical Products
United States
Our current and contemplated activities, and the products and processes that result from such activities, are subject to substantial government
regulation. Before new pharmaceutical products may be sold in the U.S., preclinical studies and clinical trials of the products must be conducted and the
results submitted to the FDA for approval. Clinical trial programs must determine an appropriate dose and regimen, establish substantial evidence of
effectiveness and define the conditions for safe use. This is a high-risk process that requires stepwise clinical studies in which the product must successfully
meet pre-specified endpoints.
Preclinical Testing: Before beginning testing of any compounds with potential therapeutic value in human subjects in the U.S., stringent
government requirements for preclinical data must be satisfied. Preclinical testing includes both in vitro, or in an artificial environment outside of a living
organism, and in vivo, or within a living organism, laboratory evaluation and characterization of the safety and efficacy of a drug and its formulation.
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Investigational New Drug Application: All available data from animal pharmacology and toxicology studies are included in an Investigational New
Drug application (“IND”) submitted to the FDA and are reviewed by the FDA prior to commencement of first-in-human clinical trials. The preclinical data
must provide an adequate basis for evaluating both the safety and the scientific rationale for the initial clinical studies in human subjects. In certain cases
where human clinical data from ex-U.S. studies are available prior to submitting the IND, these data would also be included in the IND for review by the
FDA prior to commencing clinical trials in the U.S. In addition, information pertaining to the composition, manufacturer, stability, and controls used for
manufacturing the drug substance and the drug product are included in the IND to support identification, quality, purity, and strength of the investigational
drug product.
Clinical Trials: Clinical trials involve the administration of an investigational drug to healthy human volunteers or to patients under the supervision
of a qualified investigator pursuant to an FDA-reviewed protocol. Human clinical trials are typically conducted in three sequential phases, although the
phases may overlap with one another and, depending upon the nature of the clinical program, a specific phase or phases may be skipped altogether. Clinical
trials must be conducted under protocols that detail the objectives of the study, the parameters to be used to monitor safety, and the efficacy criteria, if any,
to be evaluated. Each protocol must be submitted to the FDA as part of the applicable IND.
•
Phase 1 clinical trials—test for safety, tolerability, absorption, bio-distribution, metabolism, excretion and clinical pharmacology and, if
possible, to gain early evidence regarding efficacy.
•
Phase 2 clinical trials—involve a relatively small sample of the intended patient population and seek to assess the efficacy of the drug for
targeted indications, to determine dose-response and the optimal dose range and to gather additional information relating to the safety profile.
•
Phase 3 clinical trials—consist of expanded, large-scale studies of patients with the target disease or disorder to obtain definitive statistical
evidence of the efficacy and safety of the proposed product and dosing regimen.
In the U.S., the results of the preclinical and clinical testing of a product are then submitted to the FDA in the form of a New Drug Application
(“NDA”) or a Biologics License Application (“BLA”), depending on the nature of the product. The NDA or BLA also include information pertaining to the
chemistry, manufacturing and controls (“CMC”) of the product as well as the proposed product packaging and labeling. The submission of an application is
not a guarantee that the FDA will find the application complete and accept it for filing. The FDA may refuse to file the application if it is not considered
sufficiently complete to permit a review and will inform the applicant of the reason for the refusal. The applicant may then resubmit the application and
include supplemental information.
Once an NDA or BLA is accepted for filing, the FDA has 10 months, under its standard review process, within which to review the application (for
some applications, the review process is longer than 10 months). For drugs that, if approved, would represent a significant improvement in the safety or
effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications, the FDA may assign “priority
review” designation and review the application within six months of filing. The FDA has additional review pathways to expedite development and review
of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs, including: “Fast
Track,” “Breakthrough Therapy,” and “Accelerated Approval.” However, none of these expedited pathways ensure that a product will receive FDA
approval in a timely manner or at all.
As part of its review, the FDA may refer the application to an advisory committee for independent advice on questions related to the development of
the drug, recommendation as to whether the application should be approved or other guidance that the FDA may seek. The FDA is not bound by the
recommendation of an advisory committee; however, historically, it has often followed such recommendations. The FDA may determine that a Risk
Evaluation and Mitigation Strategy (“REMS”) is necessary to ensure that the benefits of a new product outweigh its risks. If required, a REMS may include
various elements, such as publication of a medication guide, a patient package insert, a communication plan to educate healthcare providers of the drug’s
risks, limitations on who may prescribe or dispense the drug, or other measures that the FDA deems necessary to support the safe use of the drug.
In reviewing an NDA or BLA, the FDA may grant marketing approval, or issue a complete response letter to communicate to the applicant the
reasons the application cannot be approved in its then-current form and provide input on the additional information that the FDA requires and/or changes
that must be made before an application can be approved. Even if such additional information is submitted to the FDA or such changes made, the FDA may
ultimately decide that the NDA or BLA still does not satisfy the FDA’s criteria for approval. The receipt of regulatory approval often takes a number of
years, involves the expenditure of substantial resources and depends on a number of factors, including the severity of the disease in question, the
availability of alternative treatments, efficacy and potential safety signals observed in preclinical tests or clinical trials, and the risks and benefits
demonstrated in clinical trials. It is impossible to predict with any certainty whether and when the FDA will grant marketing approval for a given product.
Even if a product is approved, the approval may be subject to limitations based on the FDA’s interpretation of the data. For example, the FDA may require,
as a condition of approval, restricted distribution and use, enhanced labeling, special packaging or
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labeling, expedited reporting of certain adverse events, pre-approval of promotional materials or restrictions on direct-to-consumer advertising, any of
which could negatively impact the commercial success of a drug. The FDA may also require a sponsor to conduct additional post-marketing studies as a
condition of approval to provide data on safety and effectiveness. In addition, prior to commercialization, products that may be deemed controlled
substances are subject to review and scheduling by the DEA.
The FDA tracks information on side effects and adverse events reported during clinical studies and after marketing approval. Non-compliance with
safety reporting requirements may result in civil or criminal penalties. Side effects or adverse events that are identified during clinical trials can delay,
impede or prevent marketing approval. Based on new safety information that emerges after approval, the FDA can mandate product labeling changes,
impose a REMS or the addition of elements to an existing REMS, require new post-marketing studies (including additional clinical trials), or suspend or
withdraw approval of the product.
If we seek to make certain types of changes to an approved product, such as adding a new indication, making certain manufacturing changes, or
changing manufacturers or suppliers of certain ingredients or components, the FDA will need to review and approve such changes in advance. In the case
of adding a new indication, we would be required to demonstrate with additional clinical data that the product is safe and effective for the new intended
use. Such regulatory reviews can result in denial or modification of the planned changes, or requirements to conduct additional tests or evaluations that can
substantially delay or increase the cost of the planned changes.
In addition, the FDA regulates all advertising and promotional activities for products under its jurisdiction. A company can make only those claims
relating to safety and efficacy that are consistent with FDA regulation and guidance, and the product’s approved label. However, physicians may prescribe
legally available drugs for uses that are not described in the drug’s labeling. Such off-label uses are common across certain medical specialties and often
reflect a physician’s belief that the off-label use is the best treatment for a particular patient. The FDA does not regulate the behavior of physicians in their
choice of treatments, but the FDA regulations do impose stringent restrictions on manufacturers’ communications regarding off-label uses. Failure to
comply with applicable FDA requirements may subject a company to adverse publicity, enforcement action by the FDA and the U.S. Department of
Justice, corrective advertising and the full range of civil and criminal penalties available to the FDA and the U.S. Department of Justice.
Controlled Substances Act: The DEA regulates pharmaceutical products that are controlled substances. Controlled substances are those drugs that
appear on one of the five schedules promulgated and administered by the DEA under the Controlled Substances Act (the “CSA”). The CSA governs,
among other things, the inventory, distribution, recordkeeping, handling, security and disposal of controlled substances. For example, pharmaceutical
products that act on the CNS are often evaluated for abuse potential; if a product is then classified as a controlled substance, it must undergo scheduling by
the DEA, which is a separate process that may delay the commercial launch of such product even after FDA approval of the NDA for such product.
Further, companies with a scheduled pharmaceutical product are subject to periodic and ongoing inspections by the DEA and similar state drug
enforcement authorities to assess ongoing compliance with the DEA’s regulations. Any failure to comply with these regulations could lead to a variety of
sanctions, including the revocation, or a denial of renewal, of any DEA registration and injunctions, or civil or criminal penalties.
Outside the United States
Certain of our products are commercialized by our licensees in numerous jurisdictions outside the U.S. Most of these jurisdictions have product
approval and post-approval regulatory processes that are similar in principle to those in the U.S. In Europe, there are several mechanisms for marketing
approval, depending on the type of product for which approval is sought. Under the centralized procedure, a company submits a single application to the
European Medicines Agency (“EMA”). The marketing application is evaluated by the Committee for Medicinal Products for Human Use (“CHMP”), the
expert scientific committee of the EMA. If the CHMP determines that the marketing application fulfills the requirements for quality, safety, and efficacy, it
will submit a favorable opinion to the European Commission (“EC”). The CHMP opinion is not binding, but is typically adopted by the EC. A marketing
application approved by the EC is valid in all EU member states.
In addition to the centralized procedure, Europe also has: (i) a nationalized procedure, which requires a separate application to, and approval
determination by, each country; (ii) a decentralized procedure, whereby applicants submit identical applications to several countries and receive
simultaneous approval; and (iii) a mutual recognition procedure, where applicants submit an application to one country for review and other countries may
accept or reject the initial decision. Regardless of the approval process employed, various parties share responsibilities for the monitoring, detection and
evaluation of adverse events post-approval, including national authorities, the EMA, the EC, other relevant regulatory authorities and the marketing
authorization holder.
Good Manufacturing Practices
The FDA, the EMA, the competent authorities of the EU member states and other regulatory agencies regulate and inspect equipment, facilities and
processes used in the manufacturing of pharmaceutical products prior to approving a product. Once approval from a regulatory agency is obtained, if a
company makes a material change in manufacturing equipment, location or process,
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additional regulatory review and approval may be required. Companies also must adhere to cGMP and product-specific regulations enforced by the FDA
and other regulatory agencies both in the manufacture of clinical product and following product approval. The FDA, the EMA and other regulatory
agencies also conduct regular, periodic visits to re-inspect equipment, facilities and processes following the initial approval of a product and may also
request that certain information or records be provided in writing for review in lieu of an on-site visit. If, as a result of these inspections or records reviews,
it is determined that our equipment, facilities or processes do not comply with applicable regulations and conditions of product approval, regulatory
agencies may seek civil, criminal or administrative sanctions and/or remedies against us, including the suspension of our manufacturing operations.
Good Clinical Practices
The FDA, the EMA and other regulatory agencies promulgate regulations and standards, commonly referred to as Good Clinical Practices (“GCP”),
for designing, conducting, monitoring, auditing and reporting the results of clinical trials to ensure that the data and results are accurate and that the trial
participants are adequately protected. The FDA, the EMA and other regulatory agencies enforce GCP through periodic inspections of trial sponsors,
principal investigators, trial sites, contract research organizations (“CROs”) and institutional review boards. If our studies fail to comply with applicable
GCP, patient safety and well-being could be impacted, the clinical data generated in our clinical trials may be deemed unreliable, and relevant regulatory
agencies may require us to perform additional clinical trials before approving our marketing applications. Noncompliance can also result in civil or criminal
sanctions. We rely on third parties, including CROs, to carry out many of our clinical trial-related activities. Failure of such third parties to comply with
GCP can likewise result in rejection of our clinical trial data or other sanctions.
Hatch-Waxman Act
Under the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), Congress created an abbreviated
FDA review process for generic versions of pioneer, or brand-name, drug products. The law also provides incentives by awarding, in certain circumstances,
non-patent related marketing exclusivities to pioneer drug manufacturers. Newly approved drug products and changes to the conditions of use of approved
products may benefit from periods of non-patent-related marketing exclusivity in addition to any patent protection the drug product may have. The Hatch-
Waxman Act provides five years of new chemical entity (“NCE”) marketing exclusivity to the first applicant to gain approval of an NDA for a product that
contains an active ingredient, known as the active drug moiety, not found in any other approved product. The FDA is prohibited from accepting any
abbreviated new drug application (“ANDA”) for a generic drug or 505(b)(2) application referencing the NCE for five years from the date of approval of the
NCE, or four years in the case of an ANDA or 505(b)(2) application containing a patent challenge, and in both cases may not approve such generic drug or
505(b)(2) application until expiration of NCE marketing exclusivity. A 505(b)(2) application is an NDA in which the applicant relies, in part, on data and
the FDA’s findings of safety and efficacy from studies not conducted by or for the applicant and for which the applicant has not obtained a right of
reference. Hatch-Waxman Act exclusivities will not prevent the submission or approval of a full NDA (e.g., under 505(b)(1)), as opposed to an ANDA or
505(b)(2) application, for any drug, including, for example, a drug with the same active ingredient, dosage form, route of administration, strength and
conditions of use.
The Hatch-Waxman Act also provides three years of exclusivity for applications containing the results of new clinical investigations, other than
bioavailability studies, essential to the FDA’s approval of new uses of approved products, such as new indications, dosage forms, strengths, or conditions
of use. However, this exclusivity only protects against the approval of ANDAs and 505(b)(2) applications for the protected use and will not prohibit the
FDA from accepting or approving ANDAs or 505(b)(2) applications for other products containing the same active ingredient.
The Hatch-Waxman Act requires NDA applicants and NDA holders to provide certain information about patents related to the drug for listing in the
FDA’s Approved Drugs Product List, commonly referred to as the Orange Book. ANDA and 505(b)(2) applicants must then certify regarding each of the
patents listed with the FDA for the reference product. A certification that a listed patent is invalid or will not be infringed by the marketing of the
applicant’s product is called a “Paragraph IV certification.” If the ANDA or 505(b)(2) applicant provides such a notification of patent invalidity or
noninfringement, then the FDA may accept the ANDA or 505(b)(2) application four years after approval of the NDA for an NCE. If a Paragraph IV
certification is filed and the ANDA or 505(b)(2) application has been accepted as a reviewable filing by the FDA, the ANDA or 505(b)(2) applicant must
then, within 20 days, provide notice to the NDA holder and patent owner stating that the application has been submitted and providing the factual and legal
basis for the applicant’s opinion that the patent is invalid or not infringed. The NDA holder or patent owner may file suit against the ANDA or 505(b)(2)
applicant for patent infringement. If this is done within 45 days of receiving notice of the Paragraph IV certification, a one-time, 30-month stay of the
FDA’s ability to approve the ANDA or 505(b)(2) application is triggered. The 30-month stay begins at the end of the NDA holder’s data exclusivity
period, or, if data exclusivity has expired, on the date that the patent holder is notified. The FDA may approve the proposed product before the expiration of
the 30-month stay if a court finds the patent invalid or not infringed, or if the court shortens the period because the parties have failed to cooperate in
expediting the litigation.
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Orphan Drug Act
Under the Orphan Drug Act, the FDA may designate drugs or biologics for relatively small patient populations as orphan drugs. FDA grants orphan
drug designation to drugs intended to treat a rare disease or condition, which is one that affects fewer than 200,000 individuals in the U.S., or more than
200,000 individuals, but for which there is no reasonable expectation that the cost of developing the product and making it available in the U.S. for the
disease or condition will be recovered from U.S. sales of the product. Orphan drug designation does not shorten the duration of the regulatory review
process or lower the approval standards, but can provide important benefits, including consultation with the FDA. If a product is approved for its orphan
designated use, it may be entitled to Orphan Drug Exclusivity (“ODE”), which blocks the FDA from approving for seven years any other application for a
product that is the same drug for the same indication. ODE does not prevent approval of another sponsor’s application for different indications or uses of
the same drug, or for different drugs for the same indication.
Sales and Marketing
We are subject to various U.S. federal and state laws pertaining to healthcare fraud and abuse, including anti-kickback laws and false claims laws.
Anti-kickback laws make it illegal for a prescription drug manufacturer to solicit, offer, receive, or pay any remuneration in exchange for, or to induce, the
referral of business, including the purchase or prescription of a particular drug. Due to the broad scope of the U.S. statutory provisions, the general absence
of guidance in the form of regulations, and few court decisions addressing industry practices, it is possible that our practices might be challenged under
anti-kickback or similar laws. False claims laws prohibit anyone from knowingly and willingly presenting, or causing to be presented, for payment to third-
party payers (including Medicare and Medicaid) claims for reimbursed drugs or services that are false or fraudulent, claims for items or services not
provided as claimed or claims for medically unnecessary items or services. Activities relating to the sale and marketing of our products may be subject to
scrutiny under these laws. Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and civil monetary
penalties, as well as the possibility of exclusion from federal healthcare programs (including Medicare and Medicaid). In addition, federal and state
authorities are paying increased attention to enforcement of these laws within the pharmaceutical industry and private individuals have been active in
alleging violations of the laws and bringing suits on behalf of the U.S. government under the False Claims Act. If we were subject to allegations
concerning, or were convicted of violating, these laws, our business could be harmed. See “Item 1A—Risk Factors” in this Annual Report and specifically
those sections entitled “If there are changes in, or we fail to comply with, the extensive legal and regulatory requirements affecting the healthcare industry,
we could be subject to investigations, litigation, costs, penalties and business losses,” “Revenues generated by sales of our products depend, in part, on the
availability from third-party payers of reimbursement for our products and the extent of cost-sharing arrangements for patients (e.g., patient co-payment,
co-insurance, deductible obligations) and cost-control measures imposed, and any reductions in payment rate or reimbursement or increases in our or in
patients’ financial obligation to payers could result in decreased sales of our products and/or decreased revenues” and “The clinical study or commercial
use of our products may cause unintended side effects or adverse reactions, or incidents of misuse may occur, which could adversely affect our products,
business and share price.”
Laws and regulations have been enacted by the U.S. federal government and various states to regulate the sales and marketing practices of
pharmaceutical manufacturers. The laws and regulations generally limit financial interactions between manufacturers and healthcare providers and require
disclosure to the government and public of such interactions. The laws include federal “sunshine”, or open payments, provisions enacted in 2010 as part of
the comprehensive federal healthcare reform legislation and supplemented as part of the Substance Use-Disorder Prevention that Promotes Opioid
Recovery and Treatment for Patients and Communities Act. Such provisions apply to pharmaceutical manufacturers with products reimbursed under
certain government programs and require those manufacturers to disclose annually to the federal government (for re-disclosure to the public) certain
payments made to, or at the request of, or on behalf of, physicians or to teaching hospitals and certain payments made to physicians assistants, nurse
practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse-midwives. Certain state laws also require disclosure of
pharmaceutical pricing information and marketing expenditures. Given the ambiguity found in many of these laws and their implementation, our reporting
actions could be subject to the penalty provisions of the pertinent U.S. federal and state laws and regulations.
Pricing and Reimbursement
United States
In the U.S., sales of our products, including those sold by our licensees, and our ability to generate revenues on such sales are dependent, in
significant part, on the availability and level of reimbursement from third-party payers such as state and federal governments, including Medicare and
Medicaid, managed care providers and private insurance plans. Third-party payers are increasingly challenging the prices charged for medical products and
examining the medical necessity and cost-effectiveness of medical products, in addition to their safety and efficacy.
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Medicaid is a joint federal and state program that is administered by the states for low-income and disabled beneficiaries. Under the Medicaid rebate
program, we are required to pay a rebate for each unit of product reimbursed by the state Medicaid programs. The amount of the rebate for each product is
set by law as the greater of 23.1% of average manufacturer price (“AMP”) or the difference between AMP and the best price available from us to any
commercial or non-federal governmental customer. The rebate amount must be adjusted upward where the AMP for a product’s first full quarter of sales,
when adjusted for increases in the Consumer Price Index—Urban, is less than the AMP for the current quarter, with this difference being the amount by
which the rebate is adjusted upwards. The rebate amount is required to be recomputed each quarter based on our report of current AMP and best price for
each of our products to the Centers for Medicare & Medicaid Services (“CMS”). The terms of our participation in the rebate program impose a requirement
on us to report revisions to AMP or best price within a period not to exceed 12 quarters from the quarter in which the data was originally due. Any such
revisions could have the impact of increasing or decreasing our rebate liability for prior quarters, depending on the direction of the revision. In addition, if
we were found to have knowingly submitted false information to the government, the statute provides for civil monetary penalties per item of false
information in addition to other penalties available to the government.
Medicare is a federal program that is administered by the federal government that covers individuals age 65 and over as well as those with certain
disabilities. Medicare Part B pays physicians who administer our products under a payment methodology using average sales price (“ASP”) information.
Manufacturers, including us, are required to provide ASP information to CMS on a quarterly basis. This information is used to compute Medicare payment
rates, with rates for Medicare Part B drugs outside the hospital outpatient setting and in the hospital outpatient setting consisting of ASP plus a specified
percentage. These rates are adjusted periodically. If a manufacturer is found to have made a misrepresentation in the reporting of ASP, the statute provides
for civil monetary penalties for each misrepresentation and for each day in which the misrepresentation was applied.
Medicare Part D provides coverage to enrolled Medicare patients for self-administered drugs (i.e., drugs that do not need to be injected or otherwise
administered by a physician) and certain physician-administered drugs reimbursed under a pharmacy benefit. Medicare Part D also covers the prescription
drug benefit for dual eligible beneficiaries. Medicare Part D is administered by private prescription drug plans approved by the U.S. government and each
drug plan establishes its own Medicare Part D formulary for prescription drug coverage and pricing, which the drug plan may modify from time-to-time.
The prescription drug plans negotiate pricing with manufacturers and may condition formulary placement on the availability of manufacturer discounts.
The Medicare Part D benefit has distinct phases, where the share of drug costs paid by Medicare Part D enrollees, the Medicare Part D prescription drug
plan, drug manufacturers and Medicare varies. Prior to 2025, the phases consisted of the deductible phase, the initial coverage phase, the coverage gap and
the catastrophic coverage phase and, except for dual eligible Medicare Part D beneficiaries who qualified for low-income subsidies, drug manufacturers,
including us, were required to provide a seventy percent (70%) discount on our brand name prescription drugs utilized by Medicare Part D beneficiaries
when those beneficiaries reached the coverage gap in their drug benefits. The Inflation Reduction Act of 2022 (the “Inflation Reduction Act”) made
substantial changes to the Medicare Part D benefit design and replaced the manufacturer coverage-gap discount program with a new manufacturer discount
program that took effect in January 2025. Under the new discount program, the Medicare Part D benefit phases consist of the deductible phase, the
coverage phase and the catastrophic coverage phase, and drug manufacturers must provide a ten percent (10%) discount on their brand name prescription
drugs utilized by Medicare Part D beneficiaries during the initial coverage phase and a twenty percent (20%) discount during the catastrophic coverage
phase. For manufacturers that meet the definition of a “specified manufacturer,” the Inflation Reduction Act provides for Medicare Part D discounts to be
phased in over time, starting with a one percent (1%) discount in the initial coverage phase and a one percent (1%) discount in the catastrophic coverage
phase in 2025. These discount amounts increase each year, stepping up to a ten percent (10%) discount in the initial coverage phase in 2029 and a twenty
percent (20%) discount in the catastrophic coverage phase in 2031. Alkermes meets the criteria of a “specified manufacturer” and, therefore, will follow the
phase-in schedule for discounts to the Medicare Part D program.
Federal law also requires that any company that participates in the Medicaid Drug Rebate Program (“MDRP”) also participate in the Public Health
Services’ (including the Indian Health Services, “PHS”) pharmaceutical pricing program (the “340B program”), in order for federal funds to be available
for the manufacturer’s drugs under Medicaid and Medicare Part B. The 340B program, which is administered by the Health Resources and Services
Administration (“HRSA”), requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B “ceiling
price” for the manufacturer’s covered drugs. These 340B covered entities include certain qualifying community health clinics, a variety of entities that
receive health services grants from the Public Health Service, and multiple categories of hospitals, including children’s hospitals, critical access hospitals,
free standing cancer hospitals and hospitals that serve a disproportionate share of low-income patients. The 340B ceiling price is calculated using a
statutory formula, which is based on the average manufacturer price and rebate amount for the covered outpatient drug as calculated under the MDRP. A
regulation regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and
intentionally overcharge covered entities became effective on January 1, 2019. The scope and implementation of the 340B program continue to be the
subject of legislative and regulatory interest and ongoing litigation, the outcomes of which are difficult to predict.
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We also make our products available for purchase by authorized users of the Federal Supply Schedule (“FSS”) of the General Services
Administration pursuant to our FSS contract with the Department of Veterans Affairs. Under the Veterans Health Care Act of 1992 (the “VHC Act”), we
are required to offer deeply discounted FSS contract pricing to four federal agencies: the Department of Veterans Affairs; the Department of Defense; the
Coast Guard; and the PHS, in order for federal funding to be made available for reimbursement of any of our products by such federal agencies and certain
federal grantees. Coverage under Medicaid, the Medicare Part B program and the PHS pharmaceutical pricing program is also conditioned upon FSS
participation. FSS pricing is negotiated periodically with the Department of Veterans Affairs. FSS pricing is intended not to exceed the price that we charge
our most-favored, non-federal customer for a product. In addition, prices for drugs purchased by the Department of Veterans Affairs, Department of
Defense (including drugs purchased by military personnel and dependents through the Tricare Retail Pharmacy (“Tricare”) program), Coast Guard and
PHS are subject to a cap on pricing equal to 76% of the non-federal average manufacturer price (“non-FAMP”). An additional discount applies if non-
FAMP increases more than inflation (measured by the Consumer Price Index—Urban). In addition, if we are found to have knowingly submitted false
information to the government, the VHC Act provides for civil monetary penalties per false item of information in addition to other penalties available to
the government.
In addition, in January 2016, CMS released the final Medicaid covered outpatient drug regulation, which became effective in April 2016. This
regulation implements those changes made by the Patient Protection and Affordable Care Act (the “PPACA”) to the Medicaid drug rebate statute in 2010
and addresses a number of other issues with respect to the Medicaid program, including, but not limited to, the eligibility and calculation methodologies for
AMP and best price, and the expansion of Medicaid rebate liability to include Medicaid managed care organizations. The final Medicaid covered outpatient
drug regulation established two calculation methodologies for AMP: one for drugs generally dispensed through retail community pharmacies (“RCP”) and
one for so-called “5i drugs” (inhaled, infused, instilled, implanted or injectable drugs) “not generally dispensed” through RCPs. The regulation further
made clear that 5i drugs would qualify as “not generally dispensed” and, therefore, able to use the alternative AMP calculation, if not more than thirty
percent (30%) of their sales were to RCPs or to wholesalers for RCPs. The primary difference between the two AMP calculations is the requirement to
include in AMP, for those qualifying 5i drugs not generally dispensed through RCPs, certain payments, rebates and discounts related to sales to non-RCPs;
such inclusion often leads to a lower AMP. The decision of which AMP calculation a product is eligible to use must be made and applied on a monthly
basis based on the percentage of sales of such product to RCPs or to wholesalers for RCPs.
In September 2024, CMS released a final rule titled “Medicaid Program: Misclassification of Drugs, Program Administration and Program Integrity
Updates Under the Medicaid Drug Rebate Program,” the provisions of which generally took effect in November 2024. The rule includes several provisions
affecting manufacturers that participate in the MDRP, including, but not limited to, addressing manufacturer misclassification of their products in reports
required by the MDRP, imposing a 12-quarter deadline for manufacturer disputes or audits of state rebate invoices, and modifying the definition of
“covered outpatient drugs” for which manufacturers are required to pay rebates to include certain drugs administered in inpatient settings where the drug is
part of an inclusive payment, such inclusive payment includes an amount attributable to the drug and the number of units of the drug administered to the
patient, and where the amount paid that is attributable to the drug is based on a reimbursement methodology included in the applicable state plan.
U.S. federal and state governments regularly consider reforming healthcare coverage and lessening healthcare costs. Such reforms may include price
controls, value-based pricing and changes to the coverage and reimbursement of our products, which may have a significant impact on our business. In
August 2022, the Inflation Reduction Act was signed into law. The Inflation Reduction Act includes several provisions that will impact our business to
varying degrees, including those that impose new manufacturer financial liability on all drugs in Medicare Part D beginning in 2025, allow the U.S.
government to negotiate prices for some drugs covered under Medicare Part D beginning in 2026 and Medicare Part B beginning in 2028, and require
companies to pay rebates to Medicare for drug prices that increase faster than inflation. In addition, emphasis on managed care in the U.S. has increased
and we expect will continue to increase the pressure on drug pricing. Private insurers regularly seek to manage drug cost and utilization by implementing
coverage and reimbursement limitations through means including, but not limited to, formularies, increased out of pocket obligations and various prior
authorization requirements. Even if favorable coverage and reimbursement status is attained for one or more products for which we have received
regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
Outside the United States
Within the EU, products are paid for by a variety of payers, with governments being the primary source of payment. Governments may determine or
influence reimbursement of products. Governments may also set prices or otherwise regulate pricing. Negotiating prices with governmental authorities can
delay commercialization of products. Governments may use a variety of cost-containment measures to control the cost of products, including price cuts,
mandatory rebates, value-based pricing and reference pricing (i.e., referencing prices in other countries and using those reference prices to set a price).
Recent budgetary pressures in many EU countries are causing governments to consider or implement various cost-containment measures, such as price
freezes, increased price cuts and rebates, and expanded generic substitution and patient cost-sharing. If budget pressures continue, governments may
implement additional cost-containment measures.
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Other Regulations
Foreign Corrupt Practices Act: We are subject to the U.S. Foreign Corrupt Practices Act (the “FCPA”) and its Irish equivalent, which prohibits
corporations and their representatives from paying, offering to pay, promising, authorizing, or making payments of anything of value to any foreign
government official, government staff member, political party, or political candidate in an attempt to obtain or retain business or to otherwise influence a
person working in an official capacity. In many countries, the healthcare professionals with whom we regularly interact may meet the FCPA’s definition of
a foreign government official. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect their
transactions and to devise and maintain an adequate system of internal accounting controls.
Environmental, Health and Safety Laws: Our operations are subject to complex and increasingly stringent environmental, health and safety laws and
regulations in the countries where we operate and, in particular, where we have manufacturing facilities, namely the U.S. and Ireland. Environmental and
health and safety authorities in the relevant jurisdictions, including the Environmental Protection Agency and the Occupational Safety and Health
Administration in the U.S. and the Environmental Protection Agency and the Health and Safety Authority in Ireland, administer laws which regulate,
among other matters, the emission of pollutants into the air (including the workplace), the discharge of pollutants into bodies of water, the storage, use,
handling and disposal of hazardous substances, the exposure of persons to hazardous substances, and the general health, safety and welfare of employees
and members of the public. In certain cases, these laws and regulations may impose strict liability for pollution of the environment and contamination
resulting from spills, disposals or other releases of hazardous substances or waste and/or any migration of such hazardous substances or waste. Costs,
damages and/or fines may result from the presence, investigation and remediation of contamination at properties currently or formerly owned, leased or
operated by us and/or off-site locations, including where we have arranged for the disposal of hazardous substances or waste. In addition, we may be
subject to third-party claims, including for natural resource damages, personal injury and property damage, in connection with such contamination.
The General Data Protection Regulation (“GDPR”): The GDPR became effective in May 2018 and replaced the previous EU Data Protection
Directive (95/46). The GDPR, which governs the processing of personal data (including personal health data), applies to the Company and any of its
subsidiaries that are established in the EU to the extent that they process personal data as well as any of its subsidiaries that are established outside the EU
to the extent that they process personal data relating to EU residents for certain purposes, including any such data relating to clinical trial participants in the
EU. The GDPR imposes significant obligations on controllers and processors of personal data, including high standards for obtaining consent from
individuals to process their personal data, robust notification requirements to individuals about the processing of their personal data, a strong individual
data rights regime, mandatory data breach notifications, limitations on the retention of personal data, stringent requirements pertaining to health data, and
strict rules and restrictions on the transfer of personal data outside of the EU, including to the U.S. The GDPR also imposes additional obligations on, and
required contractual provisions to be included in, contracts between companies subject to the GDPR and their third-party processors that relate to the
processing of personal data. The GDPR allows EU member states to make additional laws and regulations in order to introduce further conditions,
including limitations, with regard to the processing of genetic, biometric or health data.
Other Laws: We are subject to a variety of financial disclosures, securities trading regulations and U.S. and Irish or EU governmental regulations as
an Irish-incorporated company publicly-listed in the U.S., including laws relating to the oversight activities of the SEC, the Irish Companies Act 2014, and
the regulations of the Nasdaq Stock Market (“Nasdaq”), on which our shares are traded. We are also subject to various laws, regulations and
recommendations relating to safe working conditions, laboratory practices, the experimental use of animals, and the purchase, storage, movement, import
and export and use and environmental matters, including disposal of hazardous or potentially hazardous substances used in connection with our research
work.
Human Capital Resources
As a global biopharmaceutical company focused on developing innovative medicines in the field of neuroscience, we have built, and continue to
devote significant resources to further develop and enhance, a comprehensive cross-functional infrastructure designed to support product development from
discovery through commercialization and lifecycle management. We seek to attract, hire, develop, recognize and retain qualified and highly skilled
employees with experience in areas such as R&D, including early discovery, medicinal chemistry, translational medicine, formulation development, and
clinical trials operations capabilities; IP prosecution, enforcement and defense; medical affairs; manufacturing operations; U.S. federal and state
government affairs; sales and marketing; and market access, among other areas. Competition for such personnel in our industry and the geographic regions
in which we operate is intense, with numerous companies also developing, launching or marketing products, including products against which our products
directly compete. We are committed to supporting our employees’ well-being in a transparent, diverse, inclusive, and collaborative environment and to
providing them with access to training, support and resources intended to help them succeed professionally, while balancing their professional and personal
lives.
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As of February 7, 2025, we had approximately 1,800 full time employees, of which approximately 1,700 were based in the U.S. and 100 were based
in Ireland. Our 2024 global voluntary attrition rate of 9.6% was below industry benchmarks. None of our employees are covered by a collective bargaining
agreement, and we consider our relations with our employees to be good.
We are an equal opportunity employer and fundamentally committed to creating and maintaining a work environment in which employees are
treated with respect and dignity. All human resources policies, practices and actions related to hiring, promotion, compensation, benefits and termination
are administered in accordance with the principles of equal employment opportunity and other legitimate criteria without regard to race, color, religion, sex,
sexual orientation, gender expression or identity, ethnicity, national origin, ancestry, age, mental or physical disability, genetic information, any veteran
status, any military status or application for military service, or membership in any other category protected under applicable laws.
In recognition of the value of our employees and their important contributions to the achievement of our business objectives, we offer market-
competitive comprehensive total rewards packages, including bonus opportunities at all levels tied to individual and company performance, and for
employees at certain levels, company equity opportunities. We are committed to designing and managing our pay programs and decisions to support
equitable pay for all employees. We have established our compensation programs based on market and benchmark data and strive to pay all employees
equitably, taking into consideration factors such as their role, skills, abilities and relevant experience. We routinely monitor our pay programs in order to
respond to market trends and maintain equity within our workforce. We offer our employees healthcare and retirement savings plan benefits, paid time off,
tuition reimbursement and other benefits designed to support healthy lifestyle choices, financial well-being and work-life balance.
In support of our business, we seek to cultivate a work environment that reflects collaboration, respect for each voice, and unwavering commitment,
and strengthens the sense of belonging among our employees. Reflecting the needs of our employees, we have established a global steering committee,
comprised of representatives from all of our locations (including field-based employees), focused on creating connections, fostering conversations, and
helping to support alignment of our efforts across the range of perspectives within our organization. We have collaborated with our employees to create
five employee resource groups, or ERGs: Limitless, a network to support people impacted by disability or illness; MOSAIC, a multicultural network;
Operation Salute, a network to support active duty military members, veterans and their families; Pride@Work, an LGBTQ+ and allies network; and
Women Inspired Network (WIN), a women’s network. These ERGs, which are open to all employees, share a common purpose of supporting and
enhancing the inclusiveness of our company culture and providing opportunities for professional development, networking, learning and building deeper
connections within Alkermes.
We encourage active employee engagement to help ensure that employees feel part of our mission and that they have a voice in the Alkermes
community. Since 2017, we have conducted periodic employee engagement surveys to understand employee sentiment regarding, and satisfaction with,
their work and experience at Alkermes, and have used, and plan to continue to use, the data collected to help inform and evolve our human capital
management strategy and initiatives. We survey employees at least annually, which allows our employees to share their insights on a regular basis and
provides us with opportunities to regularly assess and address employee feedback. As many of our office-based employees have adapted to a hybrid work
model, we have continued to implement our expanded employee communications strategies to keep all employees connected and informed.
We are committed to the professional growth and development of our employees. We conduct a comprehensive on-boarding experience that
connects newly hired employees to our business, values, culture, and people. We encourage and support our employees in their adoption of Individual
Development Plans designed to identify professional development and growth opportunities to help support their career aspirations. We frequently offer
Company-hosted trainings that cover topics including performance management, problem-solving, leadership development, diversity, communication and
mentorship, and as appropriate, more specialized skills-based programs. We also provide all employees access to our LinkedIn Learning platform, which
provides on-demand learning opportunities.
We ask our employees to help us promote and sustain workplace environments that are safe, productive and protective of the health and well-being
of our people and in compliance with applicable laws, rules and regulations. We maintain extensive corporate environmental, health, safety and security
policies, adhere to all health and safety standards set by regulators in the locations in which we operate, and routinely assess workplace risks, conduct
employee trainings and monitor our sites to reduce the risk of workplace accidents. In 2024, employee health, safety and wellness continued to be of
particular focus and importance for the Company.
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Available Information and Website Disclosure
Our principal executive offices are located at Connaught House, 1 Burlington Road, Dublin 4, Ireland D04 C5Y6. Our telephone number is +353-1-
772-8000 and our website address is www.alkermes.com. Information found on, or accessible through, our website is not incorporated into, and does not
form a part of, this Annual Report. We make available free of charge through the Investors section of our website our Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports as soon as reasonably practicable after such material is
electronically filed with, or furnished to, the SEC. We also make available on the Corporate Governance page of the Investors section of our website at
www.alkermes.com (i) the charters for the standing committees of our board of directors, including the audit and risk committee, compensation committee,
and nominating and corporate governance committee, and (ii) our Code of Business Conduct and Ethics governing our directors, officers and employees.
We intend to disclose on our website any amendments to, or waivers from, our Code of Business Conduct and Ethics that are required to be disclosed
pursuant to the rules of the SEC.
From time to time, we may use our website to distribute material information. Our financial and other material information is routinely posted to and
accessible on the Investors section of our website, available at www.alkermes.com. Investors are encouraged to review the Investors section of our website
because we may post material information on that site that is not otherwise disseminated by us.
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Item 1A. Risk Factors
You should consider carefully the risks described below in addition to the financial and other information contained in this Annual Report, including our
financial statements and related notes thereto and the matters addressed under the caption “Cautionary Note Concerning Forward-Looking Statements,”
and in our other public filings with the SEC. If any events described by the following risks actually occur, such events could materially adversely affect our
business, financial condition, cash flows or results of operations. This could cause the market price of our ordinary shares to materially decline. The risks
described below are not intended to be exhaustive and are not the only risks that we face. New risk factors can emerge from time to time, and it is not
possible to predict the impact that any factor or combination of factors may have on our business, prospects, financial condition and results of operations.
Risks Related to Our Business and Our Industry
We receive substantial revenue from our key proprietary products and our success depends on our ability to successfully manufacture and
commercialize such products.
Sales of our proprietary products comprise a significant portion of our revenues. We developed and exclusively manufacture VIVITROL for the
treatment of adults with alcohol dependence and opioid dependence, ARISTADA for the treatment of adults with schizophrenia, ARISTADA INITIO for
initiation onto ARISTADA for the treatment of adults with schizophrenia, and LYBALVI for the treatment of adults with schizophrenia and for the
treatment of adults with bipolar I disorder, and we exclusively commercialize these products in the U.S. Our success depends in large part on our ability to
continue to successfully manufacture and commercialize such products in the complex markets into which they are sold. Any significant negative
developments relating to these products could have a material adverse effect on our revenues from these products and, in turn, on our business, financial
condition, cash flows and results of operations and the market price of our ordinary shares.
We face competition in the biopharmaceutical industry.
We face intense competition in the development, manufacture, marketing and commercialization of our products from many and varied sources,
such as research institutions and other biopharmaceutical companies, including companies with similar technologies or medicines, and manufacturers of
generic drugs. Some of these competitors are also our licensees, who control the commercialization of products from which we receive manufacturing
and/or royalty revenues. For example, our proprietary products ARISTADA and LYBALVI compete with the long-acting INVEGA products and
RISPERDAL CONSTA, products from which we receive manufacturing and/or royalty revenues.
The biopharmaceutical industry is characterized by intensive research, development and commercialization efforts and rapid and significant
technological change. In many cases, there are already products on the market that may be in direct competition with our commercial products or products
in development. In addition, there are many companies with which we and our licensees compete that are developing generic versions of our products, or
products with similar technologies to ours or for use in similar indications, and many of these competitors are larger and have significantly greater
financial, operational and other resources than we do. Smaller or earlier stage companies may also prove to be significant competitors, whether through
focused or more abbreviated development programs or collaborative arrangements with large, established companies. Some of the products being
developed by our competitors are being designed to work differently than our products and may prove to be safer or more effective than our products or
achieve regulatory approval and be commercialized earlier than our products, which may render our products or technologies obsolete or noncompetitive or
make it more challenging for us to successfully commercialize our products. For a detailed discussion of the competition that we face with respect to our
current marketed products, technologies and product indications, please see the section entitled “Competition” in “Item 1—Business” in this Annual
Report. If we are unable to compete successfully in the highly competitive biopharmaceutical industry, our business, financial condition, cash flows and
results of operations could be materially adversely affected.
Our revenues from sales of our products may decrease or grow at a slower than expected rate due to many factors.
We cannot be assured that our products will be, or will continue to be, accepted in the U.S. or markets outside the U.S. or that we will be able to
maintain or increase sales of our products. Factors that may cause revenues from our products to grow at a slower than expected rate, decrease or cease all
together, include, among others:
•
the perception of physicians and other members of the healthcare community as to our products’ safety and efficacy relative to that of current
or future competing products and the willingness or ability of physicians and other members of the healthcare community to prescribe,
dispense and/or administer, and patients to use, our products;
•
unfavorable publicity concerning us, our licensees, our products, similar classes of drugs or our industry generally;
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•
the cost-effectiveness of our products and reimbursement policies of government and third-party payers that may impact use of our products;
•
the cost and availability of raw materials necessary for the manufacture of our products;
•
the successful manufacture of our products on a timely and cost-effective basis;
•
the size of the markets for our products, and patient and physician satisfaction with our products;
•
significant changes in the competitive landscape for our products, including any approvals of generic versions of our products or other
branded products that may compete with our products;
•
adverse event information relating to our products or to similar classes of drugs;
•
changes to the product labels of our products, or of products within the same drug classes, to add new significant warnings or restrictions on
use;
•
our ability to engage third parties to manufacture, package and/or distribute our products on acceptable terms, or at all;
•
the unfavorable outcome of investigations, arbitrations, litigation or other legal proceedings, including government requests for information
related to one or more of our products, securities litigation, IP litigation, including so-called “Paragraph IV” litigation relating to products
from which we receive revenue, litigation or other proceedings before the USPTO Patent Trial and Appeal Board (the “PTAB”) or its
equivalent in other jurisdictions outside of the U.S., and any other litigation or arbitration related to any of our products;
•
regulatory developments and actions related to the manufacture, commercialization or continued use of our products, including FDA actions
such as the issuance of a REMS or warning letter, or conduct of an audit by the FDA or another regulatory authority in which a
manufacturing or quality deficiency is identified;
•
the extent and effectiveness of the sales, marketing and distribution support for our products, including the size of our and our licensees’ sales
forces and investments in marketing strategies, and our and our licensees’ decisions as to the timing and volume of product orders and
shipments, the timing of product launches, and product pricing and discounting;
•
disputes with our licensees relating to the use of our technology in, and marketing and sale of, products from which we received, or currently
receive, manufacturing and/or royalty revenue and the amounts and duration of payments to be made with respect to such products;
•
exchange rate valuations and fluctuations;
•
U.S. and global political and administrative changes, conflicts and/or instability, public health matters, economic conditions and/or any
related changes in applicable laws and regulations or federal and state policy efforts, that may impact resources and markets for our products
or the systems and environments in which we operate; and
•
any other material adverse developments with respect to the commercialization of our products.
Revenues generated by sales of our products depend, in part, on the availability from third-party payers of reimbursement for our products and the
extent of cost-sharing arrangements for patients (e.g., patient co-payment, co-insurance, deductible obligations) and cost-control measures imposed,
and any reductions in payment rate or reimbursement or increases in our or in patients’ financial obligation to payers could result in decreased sales of
our products and/or decreased revenues.
In both U.S. and non-U.S. markets, sales of our products depend, in part, on adequate coverage, pricing and reimbursement from third-party payers
such as state and federal governments, including Medicare and Medicaid in the U.S. and similar programs in other countries, managed care providers and
private insurance plans. Deterioration in the timeliness, certainty and amount of reimbursement for our products, the existence of barriers to coverage of
our products (such as prior authorization, criteria for use or other requirements), increases in our financial obligation to payers, including government
payers, limitations by healthcare providers on how much, or under what circumstances, they will prescribe or administer our products or unwillingness by
patients to pay any required co-payments, or deductible amounts, could reduce the use of, and revenues generated from, our products and could have a
material adverse effect on our business, financial condition, cash flows and results of operations.
The availability of government and private reimbursement for our products and coverage restrictions that may be imposed for our products are
uncertain, as is the amount for which our products will be reimbursed. Pricing and reimbursement for our products may be adversely affected by a number
of factors, including: changes in, and implementation of, federal or state government regulations or private third-party payors’ reimbursement policies;
pressure by employers on private health insurance plans to reduce costs; and consolidation and increasing assertiveness of payors and pharmacy benefit
managers (“PBMs”) seeking price discounts or
32
rebates in connection with the placement of our products on their formularies and, in some cases, the imposition of restrictions on access or coverage of
particular drugs or pricing determined based on perceived value. We cannot predict the availability, amount, or consistency of reimbursement for, or the
prevalence and extent of other access barriers to, our products.
In the U.S., federal and state legislatures, health agencies and third-party payers continue to focus on containing the cost of healthcare. The Inflation
Reduction Act includes several provisions that will impact our business to varying degrees, including the Drug Price Negotiation Program applicable to
Medicare Parts D and B and those provisions that impose new manufacturer financial liability on all drugs in Medicare Part D beginning in 2025, and
require companies to pay rebates to Medicare for drug prices that increase faster than inflation. The Drug Price Negotiation Program is subject to ongoing
litigation, the outcome of which is difficult to predict.
In addition, economic pressure on state budgets may result in states increasingly seeking to achieve budget savings through mechanisms that limit
coverage or payment for drugs, including but not limited to price control initiatives, discounts and other pricing-related actions. State Medicaid programs
are increasingly requesting that manufacturers pay supplemental rebates and are requiring prior authorization by the state program for use of any drug.
Managed care organizations continue to seek price discounts and, in some cases, to impose restrictions on the coverage of particular drugs. U.S.
government efforts to reduce Medicaid expenses may lead to increased use of managed care organizations by Medicaid programs. This may result in
managed care organizations influencing prescription decisions for a larger segment of the population and a corresponding constraint on prices and
reimbursement for our products.
Furthermore, we may face uncertainties as a result of efforts to repeal, substantially modify or invalidate some or all of the provisions of the
PPACA, the Inflation Reduction Act and other legislation that impacts us, whether by legislative means or through litigation, and further potential reforms
to government negotiation or regulation of drug pricing. The PPACA significantly expanded coverage of mental health and substance use disorders and
provided federal parity protections to such coverage benefits. If efforts to reform or repeal PPACA, or to implement differently certain of its provisions, are
successful, such efforts and proposed legislation or other future federal or state legislative or administrative changes relating to healthcare reform and drug
pricing could adversely affect our business and financial results. Additional discounts, rebates, coverage or plan changes, restrictions or exclusions as
described above could have a material adverse effect on sales of our affected products. Our failure to obtain or maintain adequate coverage, pricing or
reimbursement for our products could have an adverse effect on our business, reputation, revenue, results of operations, financial condition and cash flows.
Many payors continue to adopt benefit plan changes that shift a greater portion of prescription costs to patients, including more limited benefit plan
designs, higher patient co-pay or co-insurance obligations and limitations on patients' use of commercial manufacturer co-pay payment assistance programs
(including through co-pay accumulator adjustment or maximization programs). Significant consolidation in the health insurance industry has resulted in a
few large insurers and pharmacy benefit managers exerting greater pressure in pricing and usage negotiations with drug manufacturers, significantly
increasing discounts and rebates required of manufacturers and limiting patient access and usage. In addition, pharmacy benefit managers have merged
with or acquired specialty and mail order pharmacies and provider groups. This consolidation, and any further consolidation, among insurers, pharmacy
benefit managers, other entities in the pharmaceutical supply chain and other payors has increased and will increase, respectively, the negotiating leverage
such entities have over us and other drug manufacturers.
In the U.S., to help patients afford our approved products, we may utilize programs to assist them, including patient assistance programs and co-pay
programs for eligible patients. Government enforcement agencies have shown increased interest in pharmaceutical companies' product and patient
assistance programs, including reimbursement support services, and a number of investigations into these programs have resulted in significant civil and
criminal settlements. Our payment support programs could become the target of similar actions. In addition, in November 2013, CMS issued guidance to
the issuers of qualified health plans sold through the PPACA’s marketplaces encouraging such plans to reject patient cost-sharing support from third parties
and indicating that CMS intends to monitor the provision of such support and may take regulatory action to limit it in the future. CMS subsequently issued
a rule requiring individual market qualified health plans to accept third-party premium and cost-sharing payments from certain government-related entities.
In September 2014, the Office of Inspector General of the U.S. Department of Health and Human Services issued a Special Advisory Bulletin warning
manufacturers that they may be subject to sanctions under the federal anti-kickback statute and/or civil monetary penalty laws if they do not take
appropriate steps to exclude Part D beneficiaries from using co-pay programs. It is possible that changes in insurer policies regarding co-pay programs
and/or the introduction and enactment of new legislation or regulatory action could restrict or otherwise negatively affect these patient support programs,
which could result in fewer patients using affected products, and therefore could have a material adverse effect on our sales, business, and financial
condition.
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If there are changes in, or we fail to comply with, the extensive legal and regulatory requirements affecting the healthcare industry, we could be subject
to investigations, litigation, costs, penalties and business losses.
Our activities, and the activities of our licensees and third-party providers, are subject to extensive government regulation. Government regulation
by various national, state and local agencies includes detailed inspections of, and controls over, research and laboratory procedures, clinical investigations,
product approvals and manufacturing, marketing and promotion, adverse event reporting, sampling, distribution, recordkeeping, storage, and disposal
practices, among others. Achieving and maintaining compliance with these regulations substantially increases the time, difficulty and costs incurred in
obtaining and maintaining approvals to market newly developed and existing products. Government regulatory actions, including audits, records requests
and inspections of manufacturing facilities, can result in delay in the release of products, seizure or recall of products, suspension or revocation of the
authority necessary for the manufacture and sale of products, and other regulatory enforcement actions, including the levying of civil fines or criminal
penalties, the issuance of a warning letter, or the imposition of an injunction.
Biopharmaceutical companies have also been the target of government lawsuits and investigations alleging violations of government regulation,
including claims asserting submission of incorrect pricing information, impermissible promotion of pharmaceutical products, improper payments intended
to influence the referral of healthcare business, submission of false claims for government reimbursement, antitrust violations, violations related to anti-
corruption and anti-bribery laws, and violations related to environmental matters. We have been, and may continue to be, the subject of certain government
inquiries or requests for documentation. For example, we have received a subpoena and civil investigative demands from U.S. state and federal authorities
for documents related to VIVITROL, and have cooperated with the government in each instance. If, as a result of government requests, proceedings are
initiated, including under the U.S. federal Anti-Kickback Statute or False Claims Act, or under state False Claims Acts or other laws, and we are found to
have violated one or more applicable laws, we may be subject to significant liability, including without limitation, civil fines, criminal fines and penalties,
civil damages and exclusion from U.S. federal funded healthcare programs such as Medicare and Medicaid, any of which could materially affect our
reputation, business, financial condition, cash flows and results of operations. Conduct giving rise to such liability could also form the basis for private civil
litigation by third-party payers or other persons allegedly harmed by such conduct. Additionally, regardless of whether or not there is merit to claims
underlying any investigation or legal proceedings to which we are subject, or whether or not we are found as a result of such investigations or lawsuits to
have violated any applicable laws, such lawsuits and inquiries can be expensive to defend or respond to, may divert the attention of our management and
other resources that would otherwise be engaged in managing our business, and may further cause significant and potentially irreparable harm to our public
reputation. While we have implemented numerous risk mitigation measures, we cannot guarantee that we, our employees, our licensees, our consultants or
our contractors are, or will be, in compliance with all applicable laws or regulations. If we or our agents fail to comply with any of those laws or
regulations, a range of actions could result, including the suspension or termination of clinical trials, the failure to approve a product, restrictions on sales of
our products or our manufacturing processes, withdrawal of our products from the market, significant fines, exclusion from government healthcare
programs or other sanctions or litigation.
Changes affecting the healthcare industry, including new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations
or decisions, related to patent protection and enforcement, access to healthcare, environmental issues or product pricing and marketing, could also
adversely affect our revenues, our public reputation or our potential to be profitable. For example, and as discussed above, the Inflation Reduction Act
includes several provisions that will impact our business to varying degrees, including those that impose new manufacturer financial liability on all drugs in
Medicare Part D beginning in 2025, allow the U.S. government to negotiate prices for some drugs covered under Medicare Part B and Part D with effect
beginning in 2026, and require companies to pay rebates to Medicare for drug prices that increase faster than inflation. Additionally, in its 2024 decision in
Loper Bright Enterprises v. Raimondo, the U.S. Supreme Court overruled the “Chevron doctrine,” which gave deference to regulatory agencies’ statutory
interpretations in litigation against federal government agencies, such as the FDA, where the law was ambiguous. This U.S. Supreme Court decision may
lead to challenges of longstanding decisions and policies of the FDA, and other federal agencies, which could lead to uncertainties in the industry and
disrupt or alter such federal agencies’ operations. Any further changes in laws, regulations or decisions or in the interpretation of existing laws, regulations
and decisions, could have a material adverse effect on our business, financial condition, cash flows and results of operations.
We rely heavily on our licensees in the commercialization and continued development of products from which we receive revenue and, if our licensees
are not effective, or if disputes arise in respect of our contractual arrangements, our revenues could be materially adversely affected.
Our arrangements with licensees are critical to bringing to market and/or successfully commercializing products using our proprietary technologies
and from which we receive manufacturing and/or royalty revenue. We rely on these licensees in various respects, including commercializing such products,
conducting development activities with respect to new formulations or new indications for such products, and/or managing the regulatory approval process
for such products.
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We earn significant royalty revenue from sales by our licensees of our licensed products and third-party products incorporating our proprietary
technologies. We also earn manufacturing revenues for products that we currently manufacture on behalf of other parties. The revenues we receive from
such products depend primarily upon the success of our licensees in commercializing such products. For example, we receive substantial revenue from
Janssen’s sales of XEPLION, INVEGA TRINZA/TREVICTA, INVEGA HAFYERA/BYANNLI and RISPERDAL CONSTA, and from Biogen’s sales of
VUMERITY. We have no involvement in the commercialization efforts for these and other products sold by third parties from which we receive revenue
and cannot control the extent or effectiveness of such commercialization efforts. In addition, certain of these products are currently subject to ANDA
litigation proceedings to which we are not a party and, if such proceedings are not resolved favorably or are settled by our licensees, generic versions of
these products could be launched and there may be an adverse impact on the commercialization of these products and therefore on the revenue that we
receive from sales of these products.
Disputes may also arise between us and a licensee involving the ownership of technology developed under a license, the use of our technology,
including know-how, in third-party products, the terms and amounts of royalty payments to be paid under a license, or other issues arising out of any
licenses or other collaborative agreements. Such disputes may delay related development programs, impact commercialization or manufacturing activities
for the related products, impact the timing or amount of revenue that we receive in respect of such products, or result in expensive arbitration, litigation or
other dispute resolution, which may not be resolved in our favor and may adversely impact our financial condition.
Further, certain of our license agreements may be terminated, with or without cause, or assigned in connection with a change in control or other
event, and we cannot guarantee that any of these licensing relationships will continue or that our licensees will be able or willing to continue to perform
their obligations, including development, commercialization or payment obligations, under such agreements. Any significant negative developments
relating to our relationships with our licensees could have a material adverse effect on our business, financial condition, cash flows and results of
operations and on the market price of our ordinary shares.
For example, in November 2021 we received notice of partial termination of an exclusive license agreement with Janssen. Under this license
agreement, we provided Janssen with rights to, and know-how, training and technical assistance in respect of, our small particle pharmaceutical compound
technology, known as NanoCrystal technology, which was used to develop INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA, INVEGA
HAFYERA/BYANNLI, and CABENUVA. While we ultimately prevailed in arbitration proceedings related to, among other things, this partial termination
and Janssen’s royalty and other obligations under the license agreement, the announcement of the partial termination, expectations regarding the loss of
royalty revenues, actual delays in receipt of royalty revenues that resulted from such termination, and the ultimate announcement of the resumption of
payment of such royalty revenues, caused the market price of our ordinary shares to fluctuate significantly.
For these and other reasons that may be outside of our control, our revenues from products sold by our licensees, and any related commercial
milestone payments, may fall below our expectations, the expectations of our licensees or those of our shareholders, which could have a material adverse
effect on our results of operations and the market price of our ordinary shares.
Clinical trials for our products are expensive, may take several years to complete, and their outcomes are uncertain.
In order to obtain regulatory approvals for the commercial sale of any product, we or our licensees must demonstrate, through preclinical testing and
clinical trials, that such product is safe and effective for use in humans. Designing, conducting and completing a clinical development program is often a
lengthy, time-consuming and expensive process and the risk of a product not successfully completing full clinical development and receiving marketing
approval is high. We have incurred, and we will continue to incur, substantial expenses for preclinical testing, clinical trials and other activities related to
our clinical development programs.
Our preclinical and clinical development efforts may take several years or more, varying substantially with the type, complexity, novelty and
intended use of the product and the clinical study designs and methodologies employed, and may not be successfully completed in a timely manner or at
all. Timelines for the initiation, conduct and completion of clinical trials may be delayed by many factors, including:
•
issues with the opening, operation or inspection of a new or ongoing clinical trial site, including those located in or near geographic areas of
conflict or areas impacted by political, environmental, public health or economic events;
•
delays or failures of third-party CROs and other third-party service providers and clinical investigators to manage and conduct the trials,
perform oversight of the trials, including data audit and verification procedures, or to meet expected timelines;
•
an inability to recruit, enroll and retain clinical trial participants at the expected rate or at all, or to adequately follow participants after
treatment;
•
safety or tolerability issues that may arise during clinical trials;
•
an inability to manufacture or obtain sufficient quantities of materials used for clinical trials; and
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•
unforeseen governmental or regulatory issues or concerns, including those of the FDA and other regulatory agencies, that may impact the
strategies for, and design, timelines or feasibility of, our clinical development programs.
In addition, we are currently conducting and enrolling patients in clinical studies in a number of countries where our experience is more limited and
in disease areas in which we have not previously conducted clinical trials. In these instances, we must depend on third parties, including independent
clinical investigators, CROs and other third-party service providers, to successfully conduct our clinical trials and to audit, verify and accurately report
results from such trials. Though we do not have much control over many aspects of such third-party activities, we are responsible for ensuring that each of
our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Third parties may not complete planned
activities on schedule or conduct our trials in accordance with regulatory requirements or our stated protocols.
The outcome of our clinical trials is uncertain. The results from preclinical testing and early clinical trials often have not predicted results of later
clinical trials. A number of products have shown promising results in early clinical trials but subsequently failed to establish sufficient safety and/or
efficacy data in later clinical trials to obtain necessary regulatory approvals.
If we and/or third parties fail to manage or conduct clinical trials in a timely manner or in accordance with study protocols or obligations or if a
product fails to demonstrate clinical safety and efficacy or to possess features that may give such product a competitive commercial advantage over other
products for the same indication, the development, approval and/or commercialization of our products may be delayed or prevented or less successful than
anticipated, and such events could materially adversely affect our business, financial condition, cash flows and results of operations.
Preliminary, topline or interim data from our clinical trials that we may announce, publish or report from time to time may change as more patient
data become available or based on subsequent audit and verification procedures, and may not be indicative of final data from such trials, data from
future trials or real-world results.
From time to time, we may announce, publish or report preliminary, topline or interim data from our clinical trials. Such data are subject to the risk
that one or more of the clinical outcomes may materially change as patients continue progressing through the study, as patient enrollment continues and/or
as more patient data become available, and such data may not be indicative of final data from such trials, data from future trials or real-world results. In
addition, such data may remain subject to audit confirmation and verification procedures that may result in the final data being materially different from the
preliminary, topline or interim data disclosed. As a result, all preliminary, topline and interim data, and data from early clinical trials with a small number
of participants, should be viewed with caution until the final data or more extensive datasets are available, as applicable. Material adverse differences
between preliminary, topline or interim data and final data, or initial proof-of-concept data and data from later or larger trials, could significantly harm our
business, financial condition, cash flows and results of operations.
Our success depends, in part, on our ability to successfully obtain and maintain regulatory approval for our products.
We must obtain government approvals before marketing or selling our products. The FDA in the U.S., and comparable regulatory agencies in other
jurisdictions, impose substantial and rigorous requirements for the development, manufacture and commercialization of medicines, the satisfaction of
which can take a significant number of years and can vary substantially based upon the type, complexity and novelty of the product.
In addition, regulation is not static, and regulatory agencies, including the FDA, evolve in their staff, interpretations and practices, including as a
result of changes in government, and may impose different or more stringent requirements than currently in effect, which may adversely affect our plans
for product development, manufacture and/or commercialization. The approval procedures and the time and requirements necessary to obtain and maintain
approvals may also vary among countries. Regulatory agencies may have varying interpretations of the same data, and approval by one regulatory agency
does not ensure approval by regulatory agencies in other jurisdictions. In addition, the FDA or other regulatory agencies may choose not to communicate
with or update us during clinical testing and regulatory review periods and the ultimate decision by the FDA or other regulatory agencies regarding drug
approval or post-approval requirements may not be consistent with prior discussions with or communications from such agencies.
The product approval process can last many years, be very costly and still be unsuccessful. Regulatory approval by the FDA or other regulatory
agencies can be delayed, limited or not granted at all for many reasons, including:
•
a product may not demonstrate sufficient safety and efficacy or a sufficiently favorable benefit/risk profile for each target indication in
accordance with applicable regulatory agencies’ standards;
•
data from preclinical testing and clinical trials may be interpreted by applicable regulatory agencies in different ways than we or our licensees
interpret it;
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•
regulatory agencies may not agree with our or our licensees’ regulatory approval strategies, plans for accelerated development timelines,
components of our or our licensees’ filings such as clinical trial designs, conduct and methodologies, or the sufficiency of our or our
licensees’ submitted data to meet their requirements for product approval;
•
regulatory agencies might not approve our or our licensees’ manufacturing processes or facilities, or those of the CROs and contract
manufacturing organizations who conduct research or manufacturing work on our or our licensees’ behalf;
•
failure by our clinical investigational sites and the records kept at such sites, including any clinical trial data, to be in compliance with the
FDA’s GCP, or EU legislation governing GCP, or to pass FDA, EMA or EU member state inspections of clinical trials;
•
regulatory agencies may change their requirements for approval or post-approval marketing; and
•
adverse medical events during our clinical trials or during clinical trials of other product candidates in the same class could lead to
requirements that trials be repeated or extended, or that a development program be terminated or placed on clinical hold, even if other studies
or trials relating to the program are successful.
In addition, disruptions at the FDA and other regulatory agencies that are unrelated to our company or our products, including those relating to a
prolonged U.S. government shutdown, or other global, political or economic conditions, could cause delays to the regulatory approval process for our
products.
Any failure to obtain, or delay in obtaining, regulatory approval for our products will prevent or delay their commercialization and could have a
material adverse effect on our business, financial condition, cash flows and results of operations. In addition, any failure to obtain, or delay in obtaining,
approval for our products could have a material impact on our shareholders’ confidence in the strength of our development capabilities and/or our ability to
generate significant revenue from our development programs and could result in a significant decline in our share price.
Even if regulatory approval to market a product is granted by the FDA or other regulatory agencies, the approved label for the product may not be
consistent with our initial expectations or commercial plans. For example, the FDA or other regulatory agencies may impose limitations on the clinical data
that may be included in the label for the product or the indicated uses for which, or the manner in which, the product may be marketed, or may impose
additional post-approval requirements, such as a REMS, with which we would need to comply in order to maintain the approval of such product. Our
business could be seriously harmed if we do not complete these post-approval requirements and, as a result, the FDA or other regulatory agencies require
us to change the label for such product, or if such post-approval requirements significantly restrict the marketing, sale or use of such product.
In addition, legislation and regulatory policies relating to post-approval requirements and restrictions on promotional activities for pharmaceutical
products, or FDA or other regulatory agency regulations, guidance or interpretations with respect to such legislation or regulatory policy may change,
which may impact the development and commercialization of our products.
Disruptions at the FDA, the SEC and other government agencies could negatively impact our business.
Disruptions at the FDA and other regulatory agencies that are unrelated to our company or our products, including due to changes in government,
could increase the time required for new drugs to be reviewed and approved, or otherwise cause delays to the regulatory approval or post-approval
processes for our products, which could adversely affect our business. The ability of the FDA or other regulatory agencies to review and approve new
products or manage post-approval requirements for marketed products can be affected by a variety of factors, including government budget and funding
levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times for
product submissions have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our
operations may rely is subject to the impacts of political events, which are inherently fluid and unpredictable.
For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the
SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, or
if other global, political or economic conditions impact the regulatory agencies with which we interact, it could significantly impact the ability of the FDA
and the SEC or other agencies to timely review and process our submissions, which could have a material adverse effect on our business.
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We may not be able to successfully expand our R&D pipeline or our commercial product portfolio, which could limit our growth potential.
Our business is focused on the development and commercialization of medicines in the field of neuroscience, and we invest substantial resources
toward the research and development of new potential product candidates to advance into clinical trials. Notwithstanding this investment, our development
programs may not yield viable product candidates in a timely manner or at all, and our product candidates may not obtain regulatory approval, which could
limit our growth potential.
In addition to our internal development programs, our strategy for pipeline and commercial portfolio expansion includes identifying and evaluating
potential transactional opportunities, including mergers and acquisitions, licenses and collaborations, and development and supply, commercialization or
co-promotion arrangements, among others, to acquire or license additional products, product candidates, or technologies that could be additive to our
business and to our strategy to create value for our shareholders. However, such transactions are highly competitive, and many other companies may pursue
the same or similar assets to those that we may consider attractive. In particular, larger companies with greater financial resources or development or
commercialization capabilities may have a competitive advantage over us. Furthermore, companies that perceive us to be a competitor may be unwilling to
assign or license rights to us. We may also be unable to enter into transactions on acceptable terms that would allow us to realize an appropriate return on
our investment. Even if we succeed in our efforts to obtain rights to suitable products, product candidates, or technologies, the competitive business
environment may result in high transaction costs, and our investment in these potential assets would remain subject to the inherent risks associated with the
development and commercialization of new medicines and may not yield the growth or success that we anticipate, which could have a material adverse
effect on our business and financial results and the market price of our ordinary shares.
We are subject to risks related to the manufacture of our products.
The manufacture of pharmaceutical products is a highly complex process in which a variety of difficulties may arise from time to time. We have in
the past, and may in the future, face unanticipated interruptions or delays in manufacturing through our internal or external supply chain and resources.
Such disruptions can occur for many reasons, including, but not limited to, the supply and quality of API, drug product and other product components and
any potential shortages of such materials; regulatory actions; failures relating to materials, manufacturing equipment or processes, quality deviations or
safety issues, vendor error, operator error, labor shortages or disputes, utility or transportation disruptions, or physical or electronic security breaches; site-
specific incidents (such as fires), environmental incidents, natural disasters and other severe weather events, including those that may occur as a result of
climate change; global disruptions such as the COVID-19 pandemic and ongoing conflicts in various regions of the world; and many other factors.
Any such problems with manufacturing processes, whether at our facilities or those of our licensees or other third parties that manufacture or
package products or components of products on our behalf, could result in product defects or shortages, manufacturing failures or products not being
manufactured to their applicable specifications, which could require us to delay shipment of products or recall products previously shipped, or could impair
our or our licensees’ ability to receive regulatory approval for a product, commercially launch a product, expand into new markets or supply products in
existing markets. We may not be able to resolve any such issues in a timely manner, or at all, which could result in declines in sales and reputational
damage as well as significant remediation costs to address any issues that arise.
We rely solely on our manufacturing facility in Wilmington, Ohio for the manufacture of VIVITROL, ARISTADA, ARISTADA INITIO,
LYBALVI and RISPERDAL CONSTA. Due to regulatory and technical requirements, we have limited ability to shift production within our facility or to
outsource any portions of our manufacturing to third parties in the event of an interruption in manufacturing or demand for manufacturing that exceeds our
capacity. Any need to transition our manufacturing processes, or portions thereof, to a third party, whether due to an interruption in our manufacturing or
due to demand for a product that exceeds our manufacturing capacity or otherwise, could take a significant amount of time and resources, may not be
successful, and could cause significant interruption or delay in our ability to supply products.
VUMERITY and other products using our NanoCrystal or OCR technologies are currently manufactured through subcontracting arrangements at
the Athlone Facility, which we previously owned and sold to Novo in May 2024. Any interruption or delay in supply from the Athlone Facility, whether
resulting from issues with equipment, materials, personnel, manufacturing processes, or internal or external quality audits or reviews, or issues related to
the subcontracting arrangements under which these products are manufactured, could result in delays in meeting our contractual obligations and could
damage our reputation and relationships with our licensees, and result in potential loss of revenues.
Manufacturing facilities also require specialized personnel and are expensive to operate and maintain. Any interruption in manufacturing, delay in a
regulatory approval or commercial launch, or recall or suspension of sales of products manufactured in our facilities, may cause operating losses as we
continue to operate our facilities and retain the required specialized personnel. In addition, any significant personnel shortages at our manufacturing
facilities or the Athlone Facility, whether temporary or prolonged, including shortages related to the labor market, may cause significant interruptions to
our supply of products.
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We are also dependent in certain cases on third parties who manufacture or distribute certain products from which we receive revenue. Supply or
manufacturing issues related to such products could materially and adversely affect sales of such products, and in turn our revenue from such products.
We rely on third parties to provide goods and services in connection with the manufacture and distribution of the products we manufacture.
We rely on third parties for the timely supply of goods and services that play a role in our manufacturing activities, including, among others,
specified raw materials, equipment, contract manufacturing, formulation and packaging services, storage and product distribution services, customer
service activities and product returns processing, and some of these goods and services for our products are currently only available from a single source or
a limited number of qualified sources. Although we actively manage these third-party relationships to support continuity, quality and compliance with
applicable regulations, events beyond our control, including natural disasters and other severe weather events, including those that may occur as a result of
climate change, or global disruptions such as the COVID-19 pandemic and ongoing conflicts in various regions in the world, could negatively impact the
continuity of supply of such materials and/or services, their quality and their compliance with applicable standards. Any such failure could materially
adversely affect our business, financial condition, cash flows and results of operations.
The manufacture of products and product components, including the procurement of bulk drug product and other materials used in the manufacture,
packaging, storage and distribution of our products, requires successful coordination among us and multiple third-party providers. Lack of capacity
available at such third-party providers or any other issues with the quality or operations of these third-party providers, including any issues related to
regulatory permits, audits or requirements, could require us to delay shipment of saleable products, recall products previously shipped or impair our ability
to supply products at all.
We endeavor to qualify and register new vendors and to develop contingency plans so that production is not materially impacted by third-party
provider issues. Nonetheless, any such third-party provider issues could increase our costs, cause us to lose revenue or market share and damage our
reputation, and may have a material adverse effect on our business, financial condition, cash flows and results of operations.
In addition, we rely heavily on the three largest pharmaceutical wholesalers in the U.S. market—Cardinal Health Inc., Cencora, and McKesson Corp
—in the distribution of the products that we market and sell in the U.S. If we are unable to maintain our business relationships with these wholesalers on
commercially acceptable terms, if these wholesalers experience prolonged business disruptions, if the buying patterns of these wholesalers fluctuate due to
seasonality or any other reason or if wholesaler buying decisions or other factors outside of our control change, our business, financial condition, cash
flows and results of operations could be materially adversely affected.
If we or our third-party providers fail to meet the stringent requirements of governmental regulation in the manufacture of our products, we could
incur substantial remedial costs and experience a reduction in sales and/or revenues.
We and the third-party providers involved in our manufacturing activities are generally required to comply with cGMP regulations and other
applicable non-U.S. standards in the manufacture of our products or components of our products. Additionally, if any of our products or components of our
products in the U.S. are scheduled by the DEA as controlled substances, we would also be subject to DEA regulations. We and our third-party providers are
subject to unannounced inspections by the FDA and other governmental agencies to confirm compliance with all applicable laws. Any changes to our
suppliers or modifications of methods of manufacturing require submission of amendments to our marketing applications to the FDA or other applicable
regulatory agencies, and ultimate acceptance by such agencies of such amendments, prior to release of product to the applicable marketplace. Our inability,
or the inability of our third-party providers, to demonstrate ongoing compliance with cGMP or other regulatory requirements could require us to withdraw
or recall products and interrupt clinical and commercial supply of our products. Any delay, interruption or other issues that may arise in the manufacture,
formulation, packaging or storage of our products as a result of a failure of our facilities or operations or the facilities or operations of third-party providers
to pass any regulatory agency inspection could significantly impair our ability to develop, obtain and maintain regulatory approval of, and commercialize
or supply, products. This interruption could increase our costs, cause us to lose revenue or market share and damage our reputation with our collaboration
partners or in the market generally.
In March 2020, in response to the COVID-19 pandemic, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was signed
into law in the U.S., and served to increase the FDA’s existing authority with respect to drug shortage measures. Under the CARES Act, for each facility
where marketed products for certain serious diseases or conditions are manufactured, or where components of such products are manufactured, we are
required to have a risk management plan in place that identifies and evaluates risks to the supply of such products or product components, which plans may
be subject to review during any FDA inspection. Each of our facilities operates in accordance with a comprehensive quality management system, which
includes risk assessment, preventive actions and regular review of inventory levels for each of the marketed products that we manufacture; however, the
FDA may not consider our risk management program to be sufficient upon inspection and we may still experience
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shortages in the supply of marketed products that we manufacture, which could materially adversely affect the patients who rely on such marketed products
and our business, financial condition, cash flows and results of operations. The FDA and various regulatory agencies outside the U.S. have inspected and
approved our commercial manufacturing facilities. However, the FDA and any other regulatory agencies may not approve any other facility that we or our
third-party providers may operate and, once approved, any of these facilities may not remain in compliance with cGMP and other regulations. Any third
party we use to manufacture bulk drug product for use in the U.S. must be licensed by the FDA. Failure by us or our third-party providers to gain or
maintain regulatory compliance with and approvals from the FDA or other regulatory agencies could materially adversely affect our business, financial
condition, cash flows and results of operations.
Our success largely depends upon our ability to attract, recognize and retain key personnel.
Our ability to compete and succeed in the highly competitive biopharmaceutical industry and in the disease states in which we market and sell
products depends largely upon our ability to attract, recognize and retain highly skilled technical, scientific, manufacturing, management, regulatory, legal,
compliance and selling and marketing personnel. Each of our executive officers and all of our employees are employed “at will,” meaning we or each
officer or employee may terminate the employment relationship at any time. We face intense competition for employees due to, among many factors, the
geographic locations in which we operate and the competitive benefits and compensation practices in our industry, and in recent years, new competition as
employees are increasingly able to work remotely. The loss of key personnel due to any of these factors or our inability to hire and retain personnel who
have technical, scientific, manufacturing, management, regulatory, legal, compliance or commercial backgrounds could materially adversely impact our
business, including the achievement of our manufacturing, research and development, commercial, financial and other operational and strategic business
objectives.
Risks Related to Intellectual Property
Patent and other IP protection for our products is key to our business and our competitive position but is uncertain.
Receiving and maintaining patent and/or trademark protection for our products and technologies, including those that are subject to our licensing
arrangements, maintaining our trade secrets, not infringing the proprietary rights of others, and preventing others from infringing our proprietary rights are
each key to our success and our competitive position.
Patent protection provides rights of exclusivity for the term of the patent. We are able to protect our proprietary rights from unauthorized use by
third parties only to the extent that our proprietary rights are covered by valid and enforceable patents or are effectively maintained as trade secrets. In this
regard, we try to protect our proprietary position by filing patent applications in the U.S. and elsewhere related to our proprietary product inventions and
improvements that are important to our business and products. Our pending patent applications, together with those we may file in the future, or those we
may license to or from third parties, may not result in patents being issued. Even if issued, such patents may not provide us with sufficient proprietary
protection or competitive advantages against competitors with similar products or technology. Because the patent positions of biopharmaceutical
companies involve complex legal and factual questions, enforceability of patents cannot be predicted with certainty. The ultimate degree of patent
protection that will be afforded to products and processes, including ours and those of our licensees, in the U.S. and in other important markets, remains
uncertain and is dependent upon the scope of protection decided upon by the patent offices, courts and lawmakers in these countries. The development of
new technologies or products may take a number of years, and there can be no assurance that any patents which may be granted in respect of such
technologies or products will not have expired or be due to expire by the time such products are commercialized, or that such patents will successfully
withstand any challenges during their respective terms.
Although we make reasonable efforts to protect our IP rights and to ensure that our proprietary products and technologies do not infringe the IP
rights of third parties, we cannot ascertain the existence of all potentially conflicting IP claims. Therefore, there is a risk that third parties may make claims
of infringement against our products or technologies. If patents exist or are issued that cover our products or technologies, we may not be able to
manufacture, use, offer for sale, sell or import such products without first getting a license from the patent holder. The patent holder may not grant us a
license on reasonable terms, or it may refuse to grant us a license at all. This could delay or prevent us from developing, manufacturing, selling or
importing those of our products that would require the license. Claims of IP infringement may also require that we redesign affected products, enter into
costly settlement or license agreements, pay costly damage awards, or face a temporary or permanent injunction prohibiting us from marketing or selling
certain of our products. Even if we have an agreement that may serve to indemnify us against such costs, the indemnifying party may be unable to uphold
its contractual obligations. If we cannot, or do not, license the infringed IP on reasonable terms or at all, or substitute similar IP from another source, our
business, financial condition, cash flows and results of operations could be materially adversely affected.
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The laws of certain countries may not protect our IP rights to the same extent as the laws of the U.S., and any patents that we own or license from
others may not provide any protection against competitors. In addition, in the case of certain of our licensed products or products incorporating our licensed
technology, our licensees are responsible for prosecuting, maintaining, enforcing and defending the IP related to the product(s) from which we derive
revenue. Their failure to secure, maintain, enforce and defend this IP could materially and adversely affect our business, financial condition, cash flows,
and results of operations.
We also rely on trade secrets, know-how and inventions, which are not protected by patents, to maintain our competitive position. We try to protect
this information by entering into confidentiality agreements with parties that have access to it, such as our licensees, licensors, contract manufacturers,
potential business partners, employees and consultants. However, any of these parties may breach such agreements and may disclose our confidential
information, or our competitors might learn of the information in some other way. To the extent that our employees, consultants or contractors use IP
owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. If any trade secret, know-how or
other invention not protected by a patent were to be disclosed to, or independently developed by, a competitor, such event could materially and adversely
affect our business, financial condition, cash flows and results of operations.
Uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we or our licensees may face
claims against IP rights covering our products and competition from generic drug manufacturers.
There is considerable uncertainty within the biopharmaceutical industry about the validity, scope and enforceability of many issued patents in the
U.S. and elsewhere in the world. We cannot currently determine the ultimate scope, validity and enforceability of patents which may be granted to third
parties in the future or which patents third parties may assert are infringed by the manufacture, use or sale of our products.
Patents, if issued, may be challenged, invalidated or circumvented. As our products achieve greater commercial sales, potential competitors are more
likely to seek to challenge our patents. In the biopharmaceutical industry, there has been, and we expect that there may continue to be, significant litigation,
inter partes reviews (“IPRs”), post-grant reviews (“PGRs”) and administrative proceedings regarding patents and other IP rights. A third party may file an
IPR, PGR, interference and/or infringement action against us, including in response to patent certifications required under the Hatch-Waxman Act,
claiming that certain claims of one or more of our issued patents are invalid or that the manufacture, use, offer for sale, sale or import of our products
infringed one or more of such party’s patents. For example, in December 2024, Argentum Pharmaceuticals LLC filed a request with the USPTO for ex
parte reexamination of the validity of certain claims of our U.S. Patent No. 7,919,499 that covers VIVITROL, which request was granted in January 2025
and is pending. And in January 2025, Apotex Inc. filed with the USPTO a petition for IPR of certain claims of U.S. Patent No. 7,919,499 that cover
VIVITROL, which petition has not yet been instituted.
In addition, we may need to enforce our IP rights against third parties who infringe on our patents and other IP or challenge our patents, patent
applications or trademark applications. In the U.S., generic manufacturers of innovator drug products may file ANDAs and, in connection with such filings,
certify that their products do not infringe the innovator’s patents or that the innovator’s patents are invalid. This often results in litigation between the
innovator and the ANDA applicant, commonly known in the U.S. as “Paragraph IV” litigation, which can be expensive, protracted and distracting to
management, with no certainty of success. For example, Teva entities filed an ANDA seeking approval to engage in the commercial manufacture, use or
sale of a generic version of VIVITROL and alleged that one of our Orange-Book patents related to VIVITROL is invalid, unenforceable and/or will not be
infringed by Teva’s proposed product. In response, we initiated a Paragraph IV lawsuit against Teva in September 2020 to dispute such claims.
We may have to expend considerable time, effort and resources to defend such actions, and litigation may be necessary in some instances to
determine the validity and scope of certain of our proprietary rights. In order to avoid or resolve timely and costly IP litigation or IPR, PGR or other
administrative proceedings, we may enter into settlement agreements in which we grant an adverse party certain rights with respect to our IP. For example,
in August 2023, following a trial in the Teva patent infringement lawsuit discussed above, we entered into a confidential settlement and license agreement
(the “Settlement Agreement”) with Teva in August 2023 to resolve the proceedings between the parties. Pursuant to the terms of the Settlement Agreement,
we granted Teva a non-exclusive, royalty-free, non-transferable, non-sublicensable limited license to market and sell a generic version of VIVITROL in the
U.S. beginning on January 15, 2027, or earlier under certain circumstances. And in July 2019, in order to resolve an IPR instituted by Amneal with the
PTAB, we granted Amneal a non-exclusive license under certain patents covering VIVITROL, including the latest to expire patent covering VIVITROL in
the U.S., to market and sell a generic formulation of VIVITROL in the U.S. beginning sometime in 2027 or earlier under certain circumstances.
There can be no assurance that we or our licensees will prevail or settle any IP legal proceedings or disputes on favorable terms. Our and our
licensees’ existing patents could be invalidated, found unenforceable or found not to cover generic forms of our or our licensees’ products. If any ANDA
filers were to receive FDA approval to sell generic versions of our products or the products from which we receive revenue and/or prevail in any patent
litigation with respect to such products, our business, financial condition, cash flows and results of operations could be materially adversely affected.
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Risks Related to Regulatory or Legal Matters
Litigation or arbitration filed against Alkermes, including securities litigation, or actions (such as citizens petitions) filed against regulatory agencies in
respect of our products, may result in financial losses, harm our reputation, divert management resources, negatively impact the approval of our
products, or otherwise negatively impact our business.
We are, and may in the future become, involved in various legal proceedings, including those asserting violations of securities and/or fraud and
abuse laws and those asserting claims related to product liability, IP and/or contractual arrangements. Such proceedings may include claims for, or the
possibility of, damages or fines and penalties involving substantial amounts of money or other relief, including but not limited to civil or criminal fines and
penalties. Such legal proceedings and the preparation therefor may result in substantial costs to us and diversion of management’s attention and resources,
which in turn could harm our business. Moreover, if any of such legal proceedings were to result in an adverse outcome, such outcome could have a
material adverse effect on our business, financial condition, cash flows and results of operations.
Further, our liability insurance coverage may not be sufficient to satisfy, or may not cover, any expenses or liabilities that may arise. Additionally,
regardless of whether or not there is merit to the claims underlying any legal proceedings to which we are subject, or whether or not we are found as a
result of such lawsuits to have violated any applicable laws, such lawsuits and inquiries can be expensive to defend or respond to, may divert the attention
of our management and other resources that would otherwise be engaged in managing our business, and may further cause significant and potentially
irreparable harm to our public reputation.
We have been, and may again be, the subject of citizen petitions or litigation that request that the FDA refuse to approve, delay or withdraw
approval of, or impose additional approval requirements on our marketing applications. If successful, such petitions can significantly delay, or even
prevent, the approval of the marketing application in question or cause such marketing application approval to be withdrawn. Even if the FDA ultimately
denies such a petition, the FDA may substantially delay approval while it considers and responds to the petition, or may impose additional approval or
post-approval requirements as a result of such petition. These outcomes and others could adversely affect our share price as well as our ability to generate
revenues from the commercialization and sale of our products and products using our proprietary technologies.
The clinical study or commercial use of our products may cause unintended side effects or adverse reactions, or incidents of misuse may occur, which
could adversely affect our products, business and share price.
We cannot predict whether the clinical or commercial use of our products will produce undesirable or unintended side effects that have not been
evident in the use of, or in clinical trials conducted for, such products to date. The administration of drugs in humans carries the inherent risk of product
liability claims whether or not the drugs are actually the cause of an injury. Our products may cause, may appear to have caused or may be claimed to have
caused, injury or dangerous drug interactions, and we may not learn about or understand those claims or effects until the products have been administered
to patients for a prolonged period of time. Additionally, incidents of product misuse may occur.
These events, among others, could result in product recalls or additional regulatory controls (including additional regulatory scrutiny, REMS
programs, and/or requirements for additional labeling) or product liability actions. As our development activities progress and we continue to have
commercial sales, our product liability insurance coverage may be inadequate to satisfy liabilities that arise, we may be unable to obtain adequate coverage
at an acceptable cost or at all, or our insurer may disclaim coverage as to a future claim. This could prevent or limit the development or commercialization
of our products. In addition, the reporting of adverse safety events involving our products, including instances of product misuse, and public perceptions
about such events, could cause our product sales or share price to decline or experience periods of volatility. These types of events could have a material
adverse effect on our business, financial condition, cash flows and results of operations.
If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs, we
could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business,
financial condition, results of operations and growth prospects.
We participate in the Medicaid Drug Rebate Program, the 340B program, the U.S. Department of Veterans Affairs’ FSS pricing program, and the
Tricare program, and have obligations to report the average sales price for certain of our drugs to the Medicare program.
Pricing and rebate calculations vary across products and programs, are complex, and are often subject to interpretation by us, governmental or
regulatory agencies and the courts, which can change and evolve over time. In the case of our Medicaid pricing data, if we become aware that our reporting
for a prior quarter was incorrect, or has changed as a result of recalculation of the pricing data, we are generally obligated to resubmit the corrected data for
up to three years after those data originally were due. Such restatements and recalculations increase our costs for complying with the laws and regulations
governing the Medicaid Drug Rebate Program and could result in an overage or underage in our rebate liability for past quarters. Price recalculations also
may affect the ceiling price at which we are required to offer our products under the 340B program and give rise to an obligation to refund entities
participating in the 340B program for overcharges during past quarters impacted by a price recalculation.
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Civil monetary penalties can be applied if we are found to have knowingly submitted any false price or product information to the government, if we
are found to have made a misrepresentation in the reporting of our average sales price, if we fail to submit the required price data on a timely basis, or if we
are found to have charged 340B covered entities more than the statutorily mandated ceiling price. CMS could also decide to terminate our Medicaid drug
rebate agreement, in which case federal payments may not be available under Medicaid or Medicare Part B for our covered outpatient drugs. We cannot
assure you that our submissions will not be found by CMS to be incomplete or incorrect.
Our failure to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program and other governmental programs could
negatively impact our financial results. CMS issued a final regulation, which became effective in April 2016, to implement the changes to the Medicaid
Drug Rebate Program under the Affordable Care Act. Since that time, CMS has issued multiple proposed and final rules that change the Medicaid Drug
Rebate Program. Regulatory and legislative changes, and judicial rulings relating to the Medicaid Drug Rebate Program and related policies, have
increased and will continue to increase our costs and the complexity of compliance, have been and will continue to be time-consuming to implement, and
could have a material adverse effect on our results of operations, particularly if CMS or another agency challenges the approach we take in our
implementation.
HRSA issued a final regulation regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers
that knowingly and intentionally overcharge covered entities, which became effective in January 2019. Implementation of this regulation could affect our
obligations and potential liability under the 340B program in ways we cannot anticipate. We are also required to report the 340B ceiling prices for our
covered outpatient drugs to HRSA, which then publishes them to 340B covered entities. Any charge by HRSA that we have violated this regulation or
other requirements of the program could negatively impact our financial results. Moreover, HRSA has established an administrative dispute resolution
(“ADR”) process, which is governed by a final regulation effective June 2024, for claims by covered entities that a manufacturer engaged in overcharging,
including claims that a manufacturer limited the ability of a covered entity to purchase the manufacturer’s drugs at the 340B ceiling price, and by
manufacturers that a covered entity violated the prohibitions against diversion or duplicate discounts. Such claims are to be resolved through an ADR panel
of government officials rendering a decision that could be appealed only in federal court. An ADR proceeding could potentially subject us to discovery by
covered entities and other onerous procedural requirements and could result in additional liability. HRSA could also decide to terminate a manufacturer’s
agreement to participate in the 340B program for a violation of that agreement or other good cause shown, in which case the manufacturer’s covered
outpatient drugs may no longer be eligible for federal payment under the Medicaid or Medicare Part B program.
Further, legislation may be introduced that, if passed, would, among other things, further expand the 340B program to additional covered entities or
would require participating manufacturers to agree to provide 340B discounted pricing on drugs used in an inpatient setting, and any additional future
changes to the definition of average manufacturer price or the Medicaid rebate amount could affect our 340B ceiling price calculations and negatively
impact our results of operations. Additionally, we have implemented a policy governing the eligibility of covered entities to purchase our products at the
340B price for shipment to a contract pharmacy. We implemented this policy out of concern that contract pharmacy arrangements are diverting the benefits
of the 340B program from patients to contract pharmacies and contributing to the pervasive lack of transparency within the 340B program, rendering it
difficult to identify inappropriate duplicate discounts and product diversion. Certain pharmaceutical manufacturers and the industry group, Pharmaceutical
Research and Manufacturers of America (“PhRMA”) are involved in ongoing litigation with the HRSA regarding manufacturer initiatives that restrict
covered entities’ ability to purchase products at the 340B program price for shipment through an unlimited number of contract pharmacies. Additionally,
several states have enacted, and many other states are considering, laws that prohibit manufacturer restrictions on contract pharmacies. Certain
pharmaceutical manufacturers and PhRMA have initiated litigation challenging these state laws. The outcome of pending judicial proceedings and the
potential impact on the way in which manufacturers extend discounts to covered entities through contract pharmacies remain uncertain and negative legal
rulings, or the passage of legislation in respect of this topic, may materially adversely impact our results of operations.
We have obligations to report the average sales price for certain of our drugs to the Medicare program. In addition, we are required to report the best
price for our drugs, as defined under the Medicaid Drug Rebate Program, to CMS. Statutory or regulatory changes or changes in CMS guidance could
affect the average sales price or best price calculations for our products and the resulting Medicare payment rate or rebates we owe to state Medicaid
programs. Such changes could negatively impact our results of operations.
Pursuant to applicable law, knowing provision of false information in connection with price reporting under the U.S. Department of Veterans
Affairs, FSS or Tricare programs can subject a manufacturer to civil monetary penalties. These program obligations also contain extensive disclosure and
certification requirements. If we overcharge the government in connection with our arrangements with FSS or Tricare, we are required to refund the
difference to the government. Failure to make necessary disclosures and/or to identify contract overcharges can result in allegations against us under the
False Claims Act and other laws and regulations. Unexpected refunds to the government, and responding to a government investigation or enforcement
action, would be expensive and time-consuming, and could have a material adverse effect on our business, financial condition, results of operations and
growth prospects.
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Our business involves environmental, health and safety risks.
Our business involves the use of hazardous materials and chemicals and is subject to numerous environmental, health and safety laws and
regulations and to periodic inspections for possible violations of these laws and regulations. Under certain of these laws and regulations, we could be liable
for any contamination at our current or former properties or third-party waste disposal sites. In addition to significant remediation costs, contamination can
give rise to third-party claims for fines, penalties, natural resource damages, personal injury and damage (including property damage). The costs of
compliance with environmental, health and safety laws and regulations are significant. We have developed and implemented a proprietary risk mitigation
program to preemptively identify and address environmental, health, safety and security risks; however, there can be no assurance that a violation of
current or future environmental, health or safety laws or regulations will not occur. Any violations, even if inadvertent or accidental, or the cost of
compliance with any resulting order, fine or liability that may be imposed, could materially adversely affect our business, financial condition, cash flows
and results of operations.
Risks Related to our Financial Condition and Tax Matters
We may not be able to maintain profitability on a sustained basis.
At December 31, 2024, our accumulated deficit was $1.0 billion, which was primarily the result of net losses incurred from continuing operations
from 1987, the year Alkermes, Inc. was founded, through December 31, 2022, partially offset by net income from continuing operations over certain fiscal
periods, including net income earned during the years ended December 31, 2024 and December 31, 2023.
Our ability to maintain profitability on a sustained basis will depend on our ability to continue to grow and diversify our revenue and to effectively
and efficiently manage our costs. Factors that may impact our future revenue, and in turn our future profitability, include, among others, our or our
licensees’ (as applicable) ability to:
•
successfully commercialize VIVITROL, the ARISTADA product family, LYBALVI, VUMERITY, XEPLION, INVEGA
TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI and any other marketed products from which we earn revenue in the countries
in which such products are approved;
•
successfully develop, and obtain and maintain regulatory approval for, products in the U.S. and/or in other countries;
•
successfully manufacture our products and third-party products efficiently and in a cost-effective manner;
•
obtain adequate reimbursement coverage for our products and third-party products from insurance companies, government programs and
other third-party payers;
•
successfully protect and defend our confidential information and IP rights related to our technologies and our products;
•
achieve product development or sales milestones under our collaborative arrangements; and
•
resolve favorably any commercial disputes that may arise in respect of collaborative arrangements from which we receive revenues.
Factors that may impact our future spend, and in turn our future profitability, include, among others:
•
the scope of our research and development activities, including the number of programs, products, indications or new technologies that we
may pursue, and our ability, if sought, to share development costs through potential collaborations;
•
the time and expense required to pursue FDA and/or other regulatory approvals for our products;
•
the time and expense required to prosecute, enforce, defend and/or challenge patent and other IP rights;
•
the costs of operating and maintaining our manufacturing and research facilities, including the costs and availability of raw materials or
components of our products;
•
the costs of doing business with third-party vendors, including suppliers, manufacturers, packagers and distributors and CROs;
•
the scope and costs of our commercial activities, including expansion of our sales force and our investment in direct-to-consumer campaigns
and other initiatives;
•
the cost of possible business development activities, including licenses or acquisitions of technologies, compounds or product rights or the
potential acquisition of other assets, including equipment, facilities or businesses;
•
the costs related to potential litigation, arbitration or other legal proceedings or government requests for information;
•
the costs of defending against potential or actual proxy contests or other activist shareholder actions;
44
•
the costs of compliance with new regulations applicable to us, including those related to the measurement, reporting and assurance of
environmental performance data and other sustainability matters; and
•
the costs associated with recruiting, compensating and retaining a highly-skilled workforce in an environment where competition for highly-
skilled employees is intense.
We have broad discretion regarding use of our cash and cash equivalents and we may not allocate our cash in ways that ultimately increase the value
of our ordinary shares.
We have broad discretion in the allocation of our cash and cash equivalents and we may not allocate our cash in ways that ultimately increase the
value of our ordinary shares. We could make capital allocation decisions to utilize such funds in a way that our shareholders do not agree with or that do
not ultimately generate shareholder value in the manner they, or we, anticipate or at all. If our cash and cash equivalents are not deployed effectively or do
not generate shareholder value, we may fail to achieve expected financial results or other business objectives, which could have a material negative impact
on our financial condition, results of operations or the market price of our ordinary shares.
Certain U.S. holders of our ordinary shares may suffer adverse tax consequences if any of our non-U.S. subsidiaries are characterized as a “controlled
foreign corporation”.
In December 2017, the Tax Cuts and Jobs Act of 2017 (the “Tax Cuts and Jobs Act”) was signed into law. This legislation significantly changed
U.S. tax law by, among other things, changing the rules which determine whether a foreign corporation is treated for U.S. tax purposes as a controlled
foreign corporation (“CFC”) for taxable years ended December 31, 2017 and onwards. The impact of this change on certain holders of our ordinary shares
is uncertain and could be adverse, including potential income inclusions and reporting requirements for U.S. persons (as defined in the U.S. Internal
Revenue Code of 1986, as amended (the “Code”)) who are treated as owning (directly or indirectly) at least 10% of the value or voting power of our shares.
The determination of CFC status is complex and includes attribution rules, the application of which are not entirely certain. These changes to the attribution
rules relating to the determination of CFC status make it possible that one or more of our non-U.S. subsidiaries will be classified as a CFC. Existing and
prospective investors should consult their tax advisers regarding the potential application of these rules to their investments in our securities.
See “Certain Irish and United States Federal Income Tax Considerations – United States Federal Income Tax Considerations” in our Form S-1/A,
filed with the SEC on February 29, 2012, for additional discussion with respect to other potential U.S. federal income tax consequences of investments in
us.
If goodwill becomes impaired, we may have to take significant charges against earnings.
At December 31, 2024, we had $83.0 million of goodwill. Under accounting principles generally accepted in the U.S. (“GAAP”), we must assess, at
least annually and potentially more frequently, whether the value of goodwill has been impaired. Any reduction or impairment of the value of goodwill will
result in a charge against earnings, which could materially adversely affect our results of operations and shareholders’ equity in future periods.
Our effective tax rate may increase.
As a global biopharmaceutical company, we are subject to taxation in a number of different jurisdictions. As a result, our effective tax rate is derived
from a combination of applicable tax rates in the various places that we operate. In preparing our financial statements, we estimate the amount of tax that
will become payable in each of these places. Our effective tax rate may fluctuate depending on a number of factors, including, but not limited to, the
distribution of our profits or losses between the jurisdictions where we operate and differences in interpretation of tax laws. In addition, the tax laws of any
jurisdiction in which we operate may change in the future, which could impact our effective tax rate. Tax authorities in the jurisdictions in which we
operate may audit us. If we are unsuccessful in defending any tax positions adopted in our submitted tax returns, we may be required to pay taxes for prior
periods, interest, fines or penalties, and may be obligated to pay increased taxes in the future, any of which could have a material adverse effect on our
business, financial condition, cash flows and results of operations.
Changes in tax rules and regulations, or interpretations thereof, may adversely affect our financial condition.
The U.S. Congress, the EU, the Organization for Economic Co-operation and Development (“OECD”), and other government agencies in
jurisdictions where we and our affiliates do business are focused on the taxation of multinational corporations. As a result of this focus, the tax laws in
Ireland and the U.S. could change on a prospective or retroactive basis, and any such changes could adversely affect us.
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The Tax Cuts and Jobs Act amended Section 174 of the Code (“Section 174”) and, with effect from January 2022, eliminated the option to deduct
R&D expenses in the year incurred and instead requires taxpayers to capitalize, and subsequently amortize such expenses over five years for research
activities conducted in the U.S., and over fifteen years for research activities conducted outside of the U.S. As such, we expect a material decrease in cash
flows provided from operations and a material increase in our net U.S. deferred tax assets over the next number of years, which could have a material
adverse effect on our business, financial condition, cash flows and results of operations.
In December 2022, the EU implemented a new corporate minimum tax rate of 15% on companies with combined annual revenue of at least €750.0
million, which was transposed into Irish law effective as of January 1, 2024. We do not expect such rules to have a material effect on our business in 2025;
however, such minimum tax rate rules or other similar rules could have a material adverse effect on our business, financial condition, cash flows and results
of operations in future years.
Our deferred tax assets may not be realized.
As of December 31, 2024, we had $121.6 million of net deferred tax assets in the U.S. It is possible that some or all of the deferred tax assets will
not be realized, especially if we incur losses in the U.S. in the future. Losses may arise from operating events (including clinical program progression), or
the occurrence of significant excess tax benefits arising from the exercise of stock options and/or the vesting of restricted stock unit awards. Unless we are
able to generate sufficient taxable income in the future, a substantial valuation allowance to reduce the carrying value of our U.S. deferred tax assets may
be required, which would materially increase our expenses in the period the valuation allowance is recognized and materially adversely affect our financial
condition and results of operations.
Furthermore, we have included within our U.S. net deferred tax assets of $121.6 million an amount of $30.0 million relating to employee share-
based compensation expense. It is possible that a significant portion of this deferred tax asset will not be realized, especially if the price of our ordinary
shares remains at its current level (see “Item 5—Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities” in this Annual Report for details of the price of our ordinary shares). Unless the price of our ordinary shares increases, we will incur a deferred
tax expense as our U.S.-based employees exercise or forfeit their stock options and their restricted stock unit awards vest. This could significantly increase
our tax expense and may adversely affect our financial condition and results of operations.
The disposition of the Athlone Facility may limit our ability to use our net operating losses and result in unanticipated tax liabilities.
As of December 31, 2023, we had $94.7 million of net deferred tax assets in Ireland, including $87.5 million relating to net operating losses
(“NOLs”). These NOLs can be carried forward, without time limit, against trading income of the same trade in future accounting periods. In May 2024, we
completed the sale of the Athlone Facility to Novo. The disposition of the Athlone Facility may be deemed to result in (i) a significant change to the
existing trade such that the same trade is no longer continued, and (ii) a complete discontinuance of the existing trade and the commencement of a new
trade. We do not believe that the disposition of the Athlone Facility would amount to a significant change or a discontinuance of our existing trade;
however, the Irish Tax Authority could assert a contrary position, in which case we could become involved in tax controversy with the Irish Tax Authority
regarding possible additional tax liabilities. If we were to be unsuccessful in resolving any such tax controversy in our favor, we could be liable for
significant additional tax liabilities than that which we anticipate, which would materially adversely affect our financial condition, cash flows and results of
operations.
The IRS may not agree with our conclusion that we should be treated as a foreign corporation for U.S. federal income tax purposes.
In September 2011, the business of Alkermes, Inc., a U.S. corporation, and the drug technology business of Elan Corporation, plc, an Irish-
incorporated public limited company, were combined under Alkermes plc, an Irish-incorporated public limited company (the “Business Combination”).
For U.S. federal income tax purposes, a corporation is generally considered tax resident in the place of its incorporation. Because we are incorporated in
Ireland, we should be classified as an Irish corporation under these general rules. However, Section 7874 of the Code generally provides that a corporation
organized outside the U.S. that acquires substantially all of the assets of a corporation organized in the U.S. will be treated as a U.S. corporation (and,
therefore, a U.S. tax resident) for U.S. federal income tax purposes if shareholders of the acquired U.S. corporation own at least 80% (of either the voting
power or the value) of the stock of the acquiring foreign corporation after the acquisition by reason of holding stock in the domestic corporation, and the
“expanded affiliated group” (as defined in Section 7874) that includes the acquiring corporation does not have substantial business activities in the country
in which it is organized.
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We believe that Alkermes plc should be classified as an Irish tax resident corporation and should not be treated as a U.S. corporation for U.S. federal
income tax purposes. However, the IRS could assert a contrary position, in which case we could become involved in tax controversy with the IRS
regarding possible additional U.S. tax liability. If we were to be unsuccessful in resolving any such tax controversy in our favor, we could be liable for
significant additional U.S. federal and state income tax than those we anticipate, which would materially adversely affect our financial condition, cash
flows and results of operations.
If the separation of our oncology business completed in November 2023 does not ultimately qualify as a transaction that is generally tax-free for U.S.
federal and Irish tax purposes as we anticipate, we and/or our shareholders could be subject to significant tax liabilities.
In connection with the separation of our oncology business into Mural Oncology plc completed in November 2023, we sought and received a private
letter ruling from the IRS (the “IRS Ruling”) and an opinion from our U.S. tax advisor (the “U.S. Tax Opinion”) regarding U.S. federal income tax
consequences of the separation, including that, among other things, the separation would be expected to generally qualify as tax-free for U.S. federal
income tax purposes under Sections 368(a)(1)(D) and 355 of the Code. The IRS Ruling and/or the U.S. Tax Opinion were based on and relied on, among
other things, certain facts, assumptions, representations, and undertakings from us and Mural Oncology plc, including those relating to past and future
conduct of the companies’ respective business operations and other matters. If any of these facts, assumptions, representations, statements or undertakings
are, or become, inaccurate or incomplete, or if we or Mural Oncology plc breach any of our respective covenants in the separation documents, the IRS
Ruling and/or the U.S. Tax Opinion may be invalid and the conclusions reached therein could be jeopardized. Notwithstanding the U.S. Tax Opinion or
IRS Ruling, the IRS could determine that a distribution or any related transaction is taxable for U.S. federal income tax purposes if it determines that any of
these facts, assumptions, representations or undertakings are not correct or have been violated, or that the distribution should be taxable for other reasons,
including if the IRS were to disagree with the conclusions in the U.S. Tax Opinion. The U.S. Tax Opinion will not be binding on the IRS or the courts.
Accordingly, the IRS or the courts may challenge the conclusions stated in the U.S. Tax Opinion and such challenge could prevail. If the separation
transaction is ultimately determined to be taxable, we and/or our shareholders that are subject to U.S. federal income tax could incur significant tax
liabilities.
Furthermore, in connection with the separation, we sought and received an opinion from our Irish tax advisor (the “Irish Tax Opinion”) regarding
the Irish tax consequences of the separation. The Irish Tax Opinion was based on and relied on, among other things, certain facts, assumptions,
representations, and undertakings from us, including those relating to past and future conduct of our business operations and other matters. If any of these
facts, assumptions, representations, statements or undertakings are, or become, inaccurate or incomplete the Irish Tax Opinion may be invalid and the
conclusions reached therein could be jeopardized. The Irish Tax Opinion will not be binding on the Irish Tax Authority or the Irish courts. Accordingly, the
Irish Tax Authority or the Irish courts may challenge the conclusions stated in the Irish Tax Opinion and such challenge could prevail. In such an event, we
and/or our shareholders could incur significant tax liabilities.
Our business strategy may involve future transactions which may harm the market price of our ordinary shares or require us to seek additional funds,
and such funding may not be available on commercially favorable terms or at all and may cause dilution to our existing shareholders.
In order to achieve our business strategy, we regularly review potential transactions related to technologies, products or product rights or other
assets, and businesses that are complementary to our business, including mergers and acquisitions, licenses and collaborations, and development and
supply, commercialization or co-promotion arrangements, among others. We may choose to enter into one or more of these or other transactions at any
time, which may cause substantial fluctuations in the market price of our ordinary shares. Moreover, depending upon the nature of any transaction, we may
experience a charge to earnings, which could also materially adversely affect our results of operations and could harm the market price of our ordinary
shares.
In order to finance such transactions, we may require additional funds, and we may seek such funds through various sources, including debt and
equity offerings, corporate collaborations, bank borrowings, arrangements relating to assets, monetization of royalty streams or other financing methods or
structures. The source, timing and availability of any financing will depend on global economic conditions, credit and financial market conditions, interest
rates and other factors. If we issue additional equity securities or securities convertible into equity securities, our shareholders would suffer dilution of their
investment, and it may adversely affect the market price of our ordinary shares. In addition, under Irish law, the directors of an Irish public limited
company must have specific authority, as approved by the company’s shareholders, to allot and issue any ordinary shares (other than pursuant to employee
equity plans) and, if such directors desire to allot and issue ordinary shares for cash, such shares must first be offered on the same or more favorable terms
to the Company’s existing shareholders on a pro-rata basis, unless this statutory pre-emption right is disapplied by approval of the company’s shareholders.
In May 2024, our shareholders renewed our board of directors’ general authority to allot and issue ordinary shares in an amount equal to approximately
20% of our issued ordinary share capital (as of April 10, 2024), and to issue ordinary shares for cash on a non-pre-emptive basis in an amount equal to
approximately 20% of our issued share capital (as of April 10, 2024); however, these share issuance authorities were granted for eighteen months only, at
which point they will lapse unless renewed by our shareholders. If we are unable to obtain renewal of share issuance authorities from our shareholders, or
are otherwise
47
limited by the terms of new share issuance authorities approved by our shareholders, our ability to use our authorized but unissued share capital to effect or
to fund acquisition or other transaction opportunities, or to otherwise raise capital, could be adversely affected.
In addition, future investors or lenders may demand, and may be granted, rights superior to those of existing shareholders. If we issue debt
securities, we would likely be subject to restrictive covenants and debt service obligations that may impact our operations and financial condition. We
cannot be certain that additional financing will be available from any of these sources when needed or, if available, will be on acceptable terms. If we fail to
obtain additional capital if needed, we may not be able to execute our business strategy successfully.
Even if we are able to finance potential transactions without seeking any external financing, expenditure of a significant amount of cash on such
transactions may require difficult capital allocation decisions and may limit our ability to pursue other important business and strategic objectives, may
significantly impact our financial condition and profitability and limit our potential to return capital to shareholders. As a result of these and other potential
impacts, the market price of our ordinary shares may fluctuate significantly.
Currency exchange rates may affect revenues and expenses.
We conduct a large portion of our business in international markets. For example, we derive all of our XEPLION, TREVICTA and BYANNLI
revenues from sales in countries other than the U.S., and these sales are denominated in non-U.S. dollar (“USD”) currencies. We also incur substantial
operating costs in Ireland and face exposure to changes in the exchange ratio of the USD and the euro arising from expenses and payables at our Irish
operations that are settled in euro. Our efforts to mitigate the impact of fluctuating currency exchange rates may not be successful. As a result, currency
fluctuations among our reporting currency, USD, and the currencies in which we do business will affect our results of operations, often in unpredictable
ways. See “Item 7A—Quantitative and Qualitative Disclosures about Market Risk” in this Annual Report for additional information relating to our foreign
currency exchange rate risk.
Risks Related to our Ordinary Shares
The market price of our ordinary shares has been volatile and may continue to be volatile in the future, and could decline significantly.
The market price of our ordinary shares has fluctuated significantly from time to time. During the year ended December 31, 2024, the closing price
of our ordinary shares on the Nasdaq Global Select Market ranged from $23.01 to $32.56 per share. The market price of our ordinary shares is likely to
continue to be volatile and subject to significant price and volume fluctuations in response to market and industry factors, our results of operations, our
ability to maintain and increase sales of our products, the success of our key development programs and expansion of our development pipeline and
commercial portfolio, our ability to achieve and sustain profitability, the outcomes of business development transactions in which we may participate, our
capital allocation decisions, and other factors, including the risk factors described in this Annual Report. We have also experienced significant volatility in
the market price of our ordinary shares based on our business performance, including in relation to our commercial sales and the financial guidance that we
issue for such sales, results from our clinical development programs, and events relating to regulatory actions and interactions related to our product
candidates and commercial products.
In addition, the stock market in general, including the market for biopharmaceutical companies, has experienced extreme price and trading volume
fluctuations that have often been unrelated or disproportionate to the operating performance of those companies. In particular, negative publicity regarding
pricing and price increases by pharmaceutical companies, and potential legislation to regulate drug pricing, has negatively impacted, and may continue to
negatively impact, the market for biopharmaceutical companies. These broad market and industry factors have harmed, and in the future may harm, the
market price of our ordinary shares, regardless of our operating performance.
Our business could be negatively affected as a result of the actions of activist shareholders.
Proxy contests and other actions by activist shareholders have been waged against many companies in our industry over the last several years.
Activist shareholders may agitate, either publicly or privately, for changes to a company’s board of directors, management, structure, spend or strategic
direction, among other things.
Proxy contests and other actions by activist shareholders can be costly and time-consuming, disrupting operations and diverting the attention of
management and employees, and can lead to perceived uncertainties as to the future direction of the Company or its business that may result in the loss of
potential acquisitions, collaborations or in-licensing opportunities and make it more difficult to attract and retain qualified personnel and business partners.
In addition, if individuals are elected to our board of directors with a specific agenda, it may adversely affect our ability to effectively implement our
strategic plan in a timely manner and create additional value for our shareholders.
48
In recent years, we engaged in extensive dialogue with principals of Elliot Investment Management L.P. and Sarissa Capital Offshore Master Fund
LP and their affiliates, resulting in negotiation of settlement arrangements in 2020 and 2021 pursuant to which directors were elected to our Board and a
contested election in 2023. The extensive interactions and activities related to our engagement with activist shareholders required the expenditure of time,
energy and expense by management and our board of directors and diverted employee and management attention from business operations.
Any future activist shareholder interactions, contests, actions or requests, or the mere public presence of activist shareholders among our shareholder
base, could cause the market price of our ordinary shares to experience periods of significant volatility.
Risks Related to Information Security and Data Privacy
Information security breaches and other disruptions could compromise our information and expose us to liability, which would cause our business and
reputation to suffer.
In the ordinary course of our business, we and our third-party service providers collect, store, maintain and transmit sensitive data, including IP,
proprietary business information of ours and that of our suppliers and partners, as well as personally identifiable information of persons who use our
medicines, clinical trial participants and employees. In addition, we outsource some of our operations to a number of third-party vendors who may have, or
could gain, access to our confidential information. The secure maintenance of all such information and the secure performance of our information
technology (“IT”) systems are critical to our operations and business strategy.
As our dependency on, and the complexity of, our IT systems increases, the confidentiality, integrity and availability of our IT systems and the data
that they store is critical to managing our business. While we take prudent measures to secure our IT systems, the risk still exists that such systems may
become compromised by successful breaches, malfeasance, human error or technological fault. Moreover, the prevalent use of mobile devices to access
confidential information, remote working practices, and the increased use of artificial intelligence present new and increased risk of security breaches.
Cyber-attacks have increased in frequency, persistence, sophistication and intensity, often conducted by sophisticated and organized groups and individuals
with a wide range of motives (including, but not limited to, industrial espionage, hacktivists and organized crime). In addition to the extraction of important
information, such attacks could include the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to
affect service reliability and threaten the confidentiality, integrity and availability of our information. Certain types of attacks or breaches on our IT systems
or infrastructure, or those of our licensees and third-party providers, may go undetected for a prolonged period. Although to our knowledge we have not
experienced any material incident or interruption to date, any breakdown, invasion, corruption, destruction or breach of our, our partners’ or our third-party
providers’ technology systems could compromise such IT systems, and the information stored there could be accessed, modified, publicly disclosed, lost or
stolen. This could result in legal claims or proceedings and liability under laws that protect the privacy of personal information, demands for ransom or
other forms of blackmail, disruptions to our development programs or commercial operations, damage to our reputation and adverse effects on our
business. We retain cybersecurity insurance to cover costs and expenses related to a breach or similar event; however, there is no guarantee that such costs
and expenses would not exceed the insurance that we retain.
We may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational damage.
In the ordinary course of business, we may process personal data and other sensitive information, including proprietary and confidential business
data, trade secrets, intellectual property, data we collect about trial participants in connection with clinical trials, patient data and sensitive third-party data.
Our data processing activities subjects us to laws and regulations covering data privacy and the protection of personal information, including health
information. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy
and data protection issues which may affect our business.
In the U.S., numerous federal and state laws and regulations, including state security breach notification laws, federal and state consumer protection
laws, and state health information privacy laws (for example, the California Consumer Privacy Act of 2018 and the California Privacy Rights Act of 2020),
govern the collection, use, disclosure, and protection of personal information. Such federal and state laws and regulations may require businesses to provide
specific disclosures and implement processes to permit individuals to exercise certain privacy rights, which in each case could increase our potential
liability, increase our compliance costs, and affect our ability to collect and use personal information. The privacy regulation landscape is rapidly evolving,
and any changes to existing legislation or adoption of new state or federal regulations may further complicate compliance efforts and further increase legal
risk and compliance costs for us and the third parties upon whom we rely. In addition, each of these current and potential future laws may be subject to
varying interpretations by courts and government agencies, creating complex compliance issues for us and the third parties upon whom we rely. If we fail
to comply with applicable laws and regulations, we could be subject to penalties or sanctions, including criminal penalties if we knowingly obtain or
disclose individually identifiable health information from a covered entity in a manner that is not authorized or permitted by the Health Insurance
Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (HIPAA).
49
Numerous other countries have, or are developing, laws governing the collection, use and transmission of personal information as well. The EU and
other jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations. In the EU, for example, the GDPR
governs the processing of personal data. The GDPR imposes significant obligations on controllers and processors of personal data, including high standards
for obtaining consent from individuals to process their personal data, robust notification requirements to individuals about the processing of their personal
data, a strong individual data rights regime, mandatory data breach notifications, limitations on the retention of personal data and stringent requirements
pertaining to health data, and strict rules and restrictions on the transfer of personal data outside of the EU, including to the U.S. The GDPR also imposes
additional obligations on, and required contractual provisions to be included in, contracts between companies subject to the GDPR and their third-party
processors that relate to the processing of personal data. The GDPR allows EU member states to adopt additional laws and regulations in order to introduce
further conditions, including limitations, with regard to the processing of genetic, biometric or health data.
Adoption of the GDPR increased our responsibility and liability in relation to personal data that we process and may require us to put in place
additional mechanisms to ensure compliance. Any failure to comply with the requirements of GDPR and applicable national data protection laws of EU
member states could lead to regulatory enforcement actions and significant administrative and/or financial penalties against us (fines of up to €20,000,000
or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher), and could adversely affect our business, financial
condition, cash flows and results of operations.
General Risk Factors
A future pandemic, epidemic or outbreak of an infectious disease, may materially and adversely affect our business, financial condition and results of
operations.
Outbreaks of contagious diseases and other adverse public health developments affecting us and/or the third parties on which we rely could have a
material and adverse effect on our business, financial condition and results of operations. For example, the COVID-19 pandemic, which impacted the
operation of healthcare systems, global travel, supply and labor markets and other business and economic activity worldwide, had a disruptive and adverse
impact on our financial condition and results of operations and on those of many of the third parties on which we rely.
Although the acute COVID-19 public health emergency has lapsed, we will continue to monitor its long-term impacts, including impacts on market
practices and on the labor market, and adjust our policies and practices as needed to mitigate any adverse impacts to our business operations and financial
condition. We will also work with our internal teams and the third-parties on which we rely to assess, and seek to mitigate, the potential impacts on our
business operations and financial condition of any future outbreaks of contagious diseases or other adverse public health developments that may emerge
from time to time.
If we identify a material weakness in our internal control over financial reporting, our ability to meet our reporting obligations and the trading price of
our ordinary shares could be negatively affected.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable
possibility that a material misstatement of our financial statements will not be prevented or detected on a timely basis. Accordingly, a material weakness
increases the risk that the financial information we report contains material errors.
We regularly review and update our internal controls, disclosure controls and procedures, and corporate governance policies. In addition, we are
required under the Sarbanes-Oxley Act of 2002 to report annually on our internal control over financial reporting. Any system of internal controls, however
well designed and operated, is based in part on certain assumptions and can provide only reasonable, not absolute, assurances that the objectives of the
system are met. If we, or our independent registered public accounting firm, determine that our internal controls over financial reporting are not effective,
or we discover areas that need improvement in the future, these shortcomings could have an adverse effect on our business and financial results, and the
price of our ordinary shares could be negatively affected.
If we cannot conclude that we have effective internal control over our financial reporting, or if our independent registered public accounting firm is
unable to provide an unqualified opinion regarding the effectiveness of our internal control over financial reporting, investors could lose confidence in the
reliability of our financial statements, which could lead to a decline in the trading price of our ordinary shares. Failure to comply with reporting
requirements could also subject us to sanctions and/or investigations by Nasdaq or the SEC or other regulatory authorities.
50
The increasing use of social media platforms and artificial intelligence tools present new risks and challenges.
Social media is increasingly being used as a means of corporate communications and for purposes of social networking and commentary. We use
social media tools to communicate certain information about our business, our employees, our company values and initiatives, to support disease state
education in our areas of focus, and to provide information about our products or development programs. Additionally, the use of artificial intelligence
tools (“AI”) is increasing in the biopharmaceutical industry and, as with many developing technologies, presents risks and challenges that could affect its
further development, adoption and use. Despite our efforts to monitor evolving guidance regarding use of social media and AI and to comply with
applicable rules, regulations and regulatory guidance, such practices are evolving and can be unclear. There is a risk that the use of social media and AI by
us or our employees to communicate about our products or business or for other business purposes may cause us to be found in violation of applicable
requirements and could result in regulatory actions or legal claims against us related to off-label marketing or other prohibited activities. In addition, our
employees may knowingly or inadvertently engage on social media and with AI in ways that may not comply with our social media policy or guidelines
with respect to AI or other legal, contractual or regulatory requirements. Any misuse of social media or AI may give rise to liability, lead to the loss of
trade secrets and other IP, result in public disclosure of personal information of our employees, clinical trial participants, customers, patients using our
products, or others, result in reputational harm or lead to other consequences. Negative or inaccurate posts or comments about us or our products on any
social media or other public platforms could also damage our reputation, brand image and goodwill. Any of these events, if they were to occur, could cause
us to incur liability, face overly restrictive regulatory actions or suffer reputational or other harm to our business.
51
Item 1B. Unresolved Staff Comments
None.
Item 1C. Cybersecurity
Risk Management and Strategy
In the ordinary course of our business, we collect and store sensitive data, including IP, proprietary business information of ours and that of our
suppliers and licensees, and personally identifiable information of persons who use our medicines, clinical trial participants and employees. Our licensees
and third-party providers also possess certain of our sensitive data. The secure maintenance of such information and the secure performance of our
information technology (“IT”) systems are critical to our operations and business strategy. As our dependency on, and the complexity of, our IT systems
increases, the confidentiality, integrity and availability of our IT systems and the data that they store is critical to managing our business.
Our Information Security Management System (“ISMS”) is a key element of our information security program, designed to identify, assess, help
mitigate, and monitor IT risks across our organization, including information security risks. The ISMS is informed by the structured principles of
International Standard- ISO/IEC27001:2022 (Information security, cybersecurity, and privacy protection), which outlines guidance for the establishment,
implementation, maintenance, and improvement of information security management systems. Our ISMS is comprised of processes designed to identify
cybersecurity risks, safeguard information assets and preserve the confidentiality, integrity, and availability of information owned, managed and maintained
by us. Our ISMS includes formal written policies and procedures, technical security controls, such as automated tools designed to detect and prevent
cybersecurity incidents, and programs designed to promote internal and third-party IT risk management, audit management, incident response and security
awareness, including employee awareness trainings and other initiatives. Our ISMS includes periodic security audits, vulnerability assessments and
penetration testing to proactively identify potential system vulnerabilities. Our ISMS is periodically assessed by third-party assessors and the results of such
assessments, including any cybersecurity risks and related mitigations identified, are reported to the audit and risk committee of our board of directors, as
described below, and are used by us to improve our ISMS and our broader information security program.
As part of our information security program, we also have processes in place for management of cybersecurity risks associated with third-party
handling of our confidential information, including in such third parties’ provision of critical services on our behalf. We conduct due diligence of our third-
party vendors through an assessment of their security practices and overall risk profile, including through their completion of vendor assessment
questionnaires and ongoing monitoring of such third parties, utilizing tools such as security ratings services and periodic reassessment questionnaires.
As of the date of this Annual Report, we have not experienced any information security incidents that have materially affected, or are reasonably
likely to materially affect, our business strategy, results of operations, or financial condition, and we have not identified any current cybersecurity threats
that we believe are reasonably likely to materially affect our business strategy, results of operations, or financial condition.
Governance and Oversight
We have a multi-layered information security governance framework in place to provide oversight of our information security program and strategy,
our ISMS, and related risks and opportunities. This governance framework includes procedures for escalation of identified information security risks,
threats or incidents through various management levels, including up to our Information Security Governing Body, which is comprised of our Chief
Executive Officer, Chief Information Officer, Chief Operating Officer, Chief Financial Officer, Chief Legal Officer and other members of management,
and as appropriate, up to our board of directors.
Our information security team is responsible for developing, implementing and overseeing our Company-wide information security strategy and
related policies and practices. This team works cross-functionally throughout our organization to assess and prepare the Company for identification and
mitigation of, and if necessary respond to, information security risks. The information security team is led by our Chief Information Officer, who has over
35 years of experience in various information technology roles, including 18 years at the Company serving in roles with increasing levels of responsibility.
Our Vice President of Information Security and Technology, a Certified Information Systems Security Professional, with over 20 years of global
experience in various information security roles, including 14 years of experience at the Company, is responsible for day-to-day management of
information security team initiatives. The other members of the information security team have extensive IT, IT security and cloud industry experience, as
well as certifications pertaining to information security and privacy (such as Certified Information Security Manager, Certified Information Privacy
Technologist, GIAC Security Essentials and GIAC Information Security Professional certifications).
52
Our board of directors, as a whole and through its committees, has responsibility for the oversight of risk management. The audit and risk committee
of our board of directors specifically oversees critical risks and opportunities facing the Company and, in this context, reviews and provides feedback on
our company-wide enterprise risk management program, which encompasses risks related to IT and cybersecurity and mitigations put in place, or to be put
in place, in response to such risks and opportunities. The audit and risk committee periodically reports to the full board of directors regarding its oversight
of the Company’s enterprise risk management program and periodic risk assessment results. In addition, our board of directors receives periodic updates
from our CIO and Vice President of Information Security on our ISMS and other information security initiatives, and on our information security
governance framework.
Item 2. Properties
We lease an approximately 14,600 square foot corporate office space in Dublin, Ireland, which is our corporate headquarters. This lease expires in
2027 and does not include an additional tenant option to further extend the term.
We lease an approximately 231,000 square foot corporate office and R&D center in Waltham, Massachusetts. This lease, which commenced in
January 2020, expires in 2035 and includes a tenant option to extend the term for an additional ten-year period. We serve as the guarantor of a lease
assigned to Mural Oncology, Inc., a subsidiary of Mural Oncology plc, for a facility in Waltham, Massachusetts with approximately 180,000 square feet of
corporate offices, administrative areas and laboratories. This lease expires in 2026 and includes a tenant option to extend the term for an additional five-
year period.
We lease an approximately 7,000 square foot corporate office and administrative space in Washington, DC. This lease expires in 2029 and includes
a tenant option to extend the term for an additional five-year period.
We own an approximately 375,000 square foot manufacturing facility in Wilmington, Ohio.
We believe that our current facilities are suitable and adequate for our current and near-term preclinical, clinical and commercial requirements.
Item 3. Legal Proceedings
For information regarding legal proceedings, refer to the discussion under the heading “Litigation” in Note 19, Commitments and Contingent
Liabilities in the “Notes to Consolidated Financial Statements” in this Annual Report, which discussion is incorporated, in relevant part, into this Item 3 by
reference.
Item 4. Mine Safety Disclosures
Not Applicable.
53
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Market and shareholder information
Our ordinary shares are traded on the Nasdaq Global Select Market under the symbol “ALKS.” There were 87 shareholders of record of our
ordinary shares on February 7, 2025.
Dividends
No dividends have been paid on our ordinary shares to date, and we do not expect to pay cash dividends thereon in the foreseeable future. We
anticipate that we will generally retain a significant portion of our earnings to support our operations and our proprietary drug development programs. Any
future determination as to the payment of dividends, if at all, will be at the sole discretion of our board of directors and will depend on our financial
condition, results of operations, capital requirements and other factors that our board of directors and management deem relevant.
Repurchase of equity securities
In February 2024, our 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 on the open market
(the “Repurchase Program”). The timing and amount of any share repurchases under the Repurchase Program will be based on a variety of factors,
including but not limited to ongoing assessments of our capital needs, alternative investment opportunities, the market price of our ordinary shares and
general market conditions. The Repurchase Program has no set expiration date and may be suspended or discontinued at any time. During the year ended
December 31, 2024, we repurchased approximately 7.9 million of our ordinary shares under the Repurchase Program at an average price of $25.33,
resulting in a total cost, exclusive of any fees, commissions or other expenses related to such repurchase, of $200.0 million. All ordinary shares repurchased
were returned to treasury. As of December 31, 2024, the remaining amount authorized under the Repurchase Program was $200.0 million, exclusive of any
fees, commissions or other related expenses.
The following table sets forth our share repurchase activity for the three months ended December 31, 2024:
Period
Total Number of
Ordinary Shares
Purchased
(a)
Average Price Paid per
Ordinary Share
(b)
Total Number of
Ordinary Shares
Purchased as Part of
Publicly Announced
Program
(c)
Approximate Dollar
Value (in millions) of
Ordinary Shares that
May Yet Be Purchased
Under the Program
(d)
October 1, 2024 – October 31, 2024
4,686
28.74
—
$
200.0
November 1, 2024 – November 30, 2024
3,727
27.41
—
$
200.0
December 1, 2024 – December 31, 2024
3,413
31.43
—
$
200.0
Totals
11,826
$
29.10
—
(1)
Consists of ordinary shares acquired during the three months ended December 31, 2024 to satisfy tax withholding obligations related to the vesting of equity awards.
(2)
In February 2024, we announced approval by our board of directors of the Repurchase Program, which authorized the repurchase of our ordinary shares 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 specific timing and amounts of repurchases under
the Repurchase Program will depend on a variety of factors, including but not limited to ongoing assessments of our needs, alternative investment opportunities, the market price
of our ordinary shares and general market conditions. The Repurchase Program has no set expiration date and may be suspended or discontinued at any time.
Irish taxes applicable to U.S. holders
The following is a general summary of the main Irish tax considerations applicable to the purchase, ownership and disposition of our ordinary shares
by U.S. holders. It is based on existing Irish law and practices in effect on January 6, 2025, and on discussions and correspondence with the Irish Revenue
Commissioners. Legislative, administrative or judicial changes may modify the tax consequences described below.
(1)
(2)
(2)
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The statements do not constitute tax advice and are intended only as a general guide. Furthermore, this information applies only to our ordinary
shares held as capital assets and does not apply to all categories of shareholders, such as dealers in securities, trustees, insurance companies, collective
investment schemes and shareholders who acquire, or who are deemed to acquire, their ordinary shares by virtue of an office or employment. The
statements are in reference to individuals who are considered non-resident and non-ordinarily resident of Ireland for tax purposes. This summary is not
exhaustive and shareholders should consult their own tax advisers as to the tax consequences in Ireland, or other relevant jurisdictions where we operate,
including the acquisition, ownership and disposition of ordinary shares.
Withholding tax on dividends
While we have no current plans to pay dividends, dividends on our ordinary shares would generally be subject to Irish dividend withholding tax
(“DWT”) at 25%, unless an exemption applies. Dividends on our ordinary shares that are owned by residents of the U.S. and held beneficially through the
Depositary Trust Company (“DTC”) will not be subject to DWT provided that the address of the beneficial owner of the ordinary shares in the records of
the broker is in the U.S.
Dividends on our ordinary shares that are owned by residents of the U.S. and held directly (outside of DTC) will not be subject to DWT provided
that the shareholder that is the beneficial owner of such ordinary shares has completed the appropriate Irish DWT form and this form remains valid. Such
shareholders must provide the appropriate Irish DWT form to our transfer agent at least seven business days before the record date for the first dividend
payment to which they are entitled.
If any shareholder who is resident in the U.S. receives a dividend subject to DWT, they should generally be able to make an application for a refund
from the Irish Revenue Commissioners on the prescribed form.
Income tax on dividends
Irish income tax, if any, may arise in respect of dividends paid by us. However, a shareholder who is neither resident nor ordinarily resident in
Ireland and who is entitled to an exemption from DWT, generally has no liability for Irish income tax or to the universal social charge on a dividend from
us, unless they holds their ordinary shares through a branch or agency in Ireland which carries out a trade on their behalf.
Irish tax on capital gains
A shareholder who is neither resident nor ordinarily resident in Ireland and does not hold our ordinary shares in connection with a trade or business
carried on by such shareholder in Ireland through a branch or agency, should not be within the scope of the charge to Irish tax on capital gains on a disposal
of our ordinary shares. A shareholder who is an individual and who is temporarily not resident in Ireland may, under Irish anti-avoidance legislation, still
be liable for Irish tax on capital gains on any chargeable gain realized upon the disposal of our ordinary shares during the period in which such individual is
a non-resident.
Capital acquisitions tax
Irish capital acquisitions tax (“CAT”) is comprised principally of gift tax and inheritance tax. CAT could apply to a gift or inheritance of our
ordinary shares irrespective of the place of residence, ordinary residence or domicile of the parties. This is because our ordinary shares are regarded as
property situated in Ireland as our share register must be held in Ireland. The person who receives the gift or inheritance has primary liability for CAT.
CAT is levied at a rate of 33% above certain tax-free thresholds. The appropriate tax-free threshold is dependent upon (i) the relationship between
the donor and the recipient, and (ii) the aggregation of the values of previous gifts and inheritances received by the recipient from persons within the same
category of relationship for CAT purposes. Gifts and inheritances passing between spouses are exempt from CAT. Our shareholders should consult their
own tax advisers as to whether CAT is creditable or deductible in computing any domestic tax liabilities.
Stamp duty
Irish stamp duty, if any, may become payable in respect of ordinary share transfers. However, a transfer of our ordinary shares effected by means of
book-entry interests in DTC will not be subject to Irish stamp duty. A transfer of our ordinary shares (i) by a seller who holds ordinary shares outside of
DTC to any buyer, or (ii) by a seller who holds the ordinary shares through DTC to a buyer who holds the acquired ordinary shares outside of DTC, may be
subject to Irish stamp duty, which is currently at the rate of 1% of the price paid or the market value of the ordinary shares acquired, if greater. The person
accountable for payment of stamp duty is the buyer or, in the case of a transfer by way of a gift or for less than market value, all parties to the transfer.
A shareholder who holds ordinary shares outside of DTC may transfer those ordinary shares into DTC without giving rise to Irish stamp duty
provided that the shareholder would be the beneficial owner of the related book-entry interest in those ordinary shares recorded in the systems of DTC, and
in exactly the same proportions, as a result of the transfer and at the time of the transfer into DTC there is no sale of those book-entry interests to a third
party being contemplated by the shareholder. Similarly, a shareholder who
55
holds ordinary shares through DTC may transfer those ordinary shares out of DTC without giving rise to Irish stamp duty provided that the shareholder
would be the beneficial owner of the ordinary shares, and in exactly the same proportions, as a result of the transfer, and at the time of the transfer out of
DTC there is no sale of those ordinary shares to a third party being contemplated by the shareholder.
In order for the share registrar to be satisfied as to the application of this Irish stamp duty treatment where relevant, the shareholder must confirm to
us that the shareholder would be the beneficial owner of the related book-entry interest in those ordinary shares recorded in the systems of DTC, and in
exactly the same proportions or vice-versa, as a result of the transfer and there is no agreement for the sale of the related book-entry interest or the ordinary
shares or an interest in the ordinary shares, as the case may be, by the shareholder to a third party being contemplated.
Stock performance graph
The information contained in the performance graph and related information below shall not be deemed to be “soliciting material” or to be “filed”
with the SEC, and such information shall not be incorporated by reference into any future filing under the Securities Act or the Exchange Act, except to the
extent that we specifically incorporate it by reference into such filing.
The following graph compares the cumulative total shareholder return on our ordinary shares from December 31, 2019 through December 31, 2024
with the cumulative returns of the Nasdaq Composite Total Return Index and the Nasdaq Biotechnology Index. The comparison assumes $100 was
invested on December 31, 2019 in our ordinary shares and in each of the foregoing indices and further assumes reinvestment of any dividends. We did not
declare or pay any dividends on our ordinary shares during the comparison period.
Year Ended December 31,
2019
2020
2021
2022
2023
2024
Alkermes
100
98
114
128
136
141
Nasdaq Composite Total Return
100
145
177
119
173
224
Nasdaq Biotechnology Index
100
126
126
114
119
118
Item 6. [Reserved]
Not applicable.
56
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following should be read in conjunction with our consolidated financial statements and related notes beginning on page F-1 of this Annual
Report. The following discussion contains forward-looking statements. Actual results may differ significantly from those projected in the forward-looking
statements. See “Cautionary Note Concerning Forward-Looking Statements” on page 3 of this Annual Report. Factors that might cause future results to
differ materially from those projected in the forward-looking statements also include, but are not limited to, those discussed in “Item 1A—Risk Factors”
and elsewhere in this Annual Report. A detailed discussion of our 2022 financial condition and results of operations, and of 2023 year-over-year changes as
compared to 2022, can be found in “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual
Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on February 21, 2024.
Overview
We have a portfolio of proprietary products that we manufacture, market and sell in the U.S.—VIVITROL, ARISTADA, ARISTADA INITIO and
LYBALVI. We also earn manufacturing and/or royalty revenues on net sales of products commercialized by our licensees, the most significant of which in
2024 were the long-acting INVEGA products and VUMERITY. We expect VIVITROL, ARISTADA, ARISTADA INITIO, LYBALVI and VUMERITY
to generate significant revenues for us in the near- and medium-term as we believe these products are singular or competitively advantaged products in
their classes.
In 2024, our net income from continuing operations was $372.1 million, as compared to $519.2 million in 2023. The decrease in net income from
continuing operations was primarily due to two significant one-time events in 2023, which were the receipt in June 2023 of back royalties and interest in
respect of 2022 U.S. sales of the long-acting INVEGA products, following the successful outcome of the arbitration proceedings related to such products,
and the partial release of our valuation allowance maintained against certain Irish deferred tax assets. These events were partially offset by an increase in
our product sales, net and a decrease in our operating expenses in 2024. These items are discussed in further detail within the “Results of Operations”
section below.
Business Update
In May 2024, we completed the sale of the Athlone Facility to Novo and entered into subcontracting arrangements to continue certain development
and manufacturing activities performed at the Athlone Facility, which may continue through the end of 2025.
In November 2023, we completed the separation of our former oncology business into a new, independent, publicly-traded company (the
“Separation”), which is more fully described in Note 3, Discontinued Operations, in the “Notes to Consolidated Financial Statements” in this Annual
Report.
Results of Operations
As a result of the Separation, the historical results of our former oncology business have been reflected as discontinued operations in our
consolidated financial statements through November 15, 2023, the date of the Separation. Prior period results of operations and balance sheet information
have been recast to reflect this presentation.
Product Sales, Net
Our product sales, net, consist of sales of VIVITROL, ARISTADA, ARISTADA INITIO, and LYBALVI, primarily to wholesalers, specialty
distributors and pharmacies. The following table presents the adjustments deducted from product sales, gross to arrive at product sales, net, for sales of
these products during the years ended December 31, 2024 and 2023:
Year Ended
December 31,
(In millions, except for % of Sales)
2024
% of Sales
2023
% of Sales
Product sales, gross
$
2,119.5
100.0 % $
1,855.4
100.0 %
Adjustments to product sales, gross:
Medicaid rebates
(454.0 )
(21.4 ) %
(426.4 )
(23.0 ) %
Chargebacks
(231.5 )
(10.9 ) %
(189.1 )
(10.2 ) %
Product discounts
(155.1 )
(7.3 ) %
(137.7 )
(7.4 ) %
Medicare Part D
(83.0 )
(3.9 ) %
(74.4 )
(4.0 ) %
Other
(112.4 )
(5.4 ) %
(107.8 )
(5.8 ) %
Total adjustments
(1,036.0 )
(48.9 ) %
(935.4 )
(50.4 ) %
Product sales, net
$
1,083.5
51.1 % $
920.0
49.6 %
57
VIVITROL product sales, gross, increased by 10%, which was primarily due to a 7% increase in the number of units sold and a 3.2% increase in the
selling price that went into effect in January 2024. ARISTADA and ARISTADA INITIO product sales, gross, increased by 5%, which was primarily due to
a 3% increase in the number of units sold and a 3.0% increase in the selling price that went into effect in January 2024. LYBALVI product sales, gross,
increased by 52%, which was primarily due to a 45% increase in the number of units sold and increases of 3.8% and 2.0% in the selling price that went into
effect in January 2024 and July 2024, respectively.
The decrease in Medicaid rebates as a percentage of sales was primarily due to the increase in sales of LYBALVI, which has lower Medicaid
utilization than VIVITROL, ARISTADA and ARISTADA INITIO, and actual Medicaid utilization rates related to VIVITROL being lower than original
estimates, due, in part, to $8.7 million in actual credits received in the fourth quarter of 2024 from certain states related to duplicate Medicaid billings.
The following table compares product sales, net earned during the years ended December 31, 2024 and 2023:
Year Ended December 31,
(In millions)
2024
2023
Change
VIVITROL
$
457.3 $
400.4 $
56.9
ARISTADA and ARISTADA INITIO
346.2
327.7
18.5
LYBALVI
280.0
191.9
88.1
Product sales, net
$
1,083.5 $
920.0 $
163.5
A number of companies currently market and/or are developing products to treat addiction, including alcohol and opioid dependence, that may
compete with, and negatively impact, future sales of VIVITROL. Increased competition may lead to reduced unit sales of VIVITROL and increased pricing
pressure. The latest to expire of our patents covering VIVITROL will expire in 2029 in the U.S. Pursuant to the terms of a confidential settlement and
license agreement entered into in August 2023 with Teva, we granted Teva a non-exclusive, royalty-free, non-transferable, non-sublicensable limited
license under the remaining patent covering VIVITROL to market and sell a generic version of VIVITROL in the U.S. beginning on the First Entry Date,
or earlier under certain circumstances. Under the terms of a settlement and license agreement entered into in July 2019 with Amneal, we granted Amneal a
non-exclusive license under certain patents covering VIVITROL, including the remaining patent covering VIVITROL in the U.S., to market and sell a
generic formulation of VIVITROL in the U.S. beginning on the earlier of the First Entry Date, sometime in 2028 or earlier under certain circumstances.
A number of companies currently market and/or are developing products to treat schizophrenia and/or bipolar I disorder that may compete with and
negatively impact future sales of ARISTADA, ARISTADA INITIO and LYBALVI. Increased competition may lead to reduced unit sales of ARISTADA,
ARISTADA INITIO and LYBALVI and increased pricing pressure. The latest to expire of our patents covering ARISTADA, ARISTADA INITIO and
LYBALVI in the U.S. will expire in 2039, 2039 and 2041, respectively; and, as such, we do not anticipate any generic versions of these products to enter
the market in the near term.
Manufacturing and Royalty Revenues
Manufacturing revenue from RISPERDAL CONSTA and VUMERITY are recognized at the point in time that the product has been fully
manufactured. Royalties earned on our licensees’ net sales of products using our proprietary technologies are recognized in the period such products are
sold by our licensees. The following table compares manufacturing and royalty revenues earned in the years ended December 31, 2024 and 2023:
Year Ended December 31,
(In millions)
2024
2023
Change
Manufacturing and royalty revenues:
Long-acting INVEGA products
$
236.5
$
486.1
$
(249.6 )
VUMERITY
134.0
129.3
4.7
RISPERDAL CONSTA
23.5
37.3
(13.8 )
Other
80.1
90.7
(10.6 )
Manufacturing and royalty revenues
$
474.1
$
743.4
$
(269.3 )
The decrease in royalty revenues related to the long-acting INVEGA products was primarily due to the receipt in June 2023 of back royalties of
$195.4 million, inclusive of $8.1 million in late-payment interest, related to 2022 U.S. sales of the long-acting INVEGA products following the successful
outcome of the arbitration proceedings related to such products and the expiration of our royalty on U.S. net sales of INVEGA SUSTENNA in August
2024. Pursuant to the Final Award issued in the arbitration proceedings,
58
we are entitled to royalty revenues from Janssen related to U.S. net sales of INVEGA TRINZA and INVEGA HAFYERA through certain specified dates in
2030. We expect royalty revenues from net sales of the long-acting INVEGA products to decrease further in 2025, as the royalty revenues related to U.S.
net sales of INVEGA SUSTENNA comprised a significant portion of the overall royalty revenues for the long-acting INVEGA products.
For additional discussion of our agreements with Janssen related to the long-acting INVEGA products, including the royalty provisions set forth
therein and the related arbitration proceedings and outcome, see the section entitled “Collaborative Arrangements—Janssen” in “Item 1—Business” in this
Annual Report.
In addition, each of INVEGA SUSTENNA and INVEGA TRINZA is currently subject to Paragraph IV litigation in response to companies seeking
to market generic versions of such product. Increased competition from new products or generic versions of any one or more of the long-acting INVEGA
products may lead to reduced unit sales of the long-acting INVEGA products, including those not yet genericized, and increased pricing pressure. For a
discussion of legal proceedings related to INVEGA TRINZA, see Note 19, Commitments and Contingent Liabilities in the “Notes to Consolidated
Financial Statements” in this Annual Report, and for information about risks relating to these legal proceedings, see “Item 1A—Risk Factors” in this
Annual Report, and specifically the section entitled “Uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal
proceedings, and we or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”
The increase in VUMERITY revenue was due to an $8.3 million increase in royalty revenue, partially offset by a $3.6 million decrease in
manufacturing revenue. The increase in royalty revenue was primarily due to an increase in end-market sales of VUMERITY to $628.0 million in 2024, as
compared to $576.3 million in 2023. The decrease in manufacturing revenue was primarily due to a reduction in the selling price. The manufacturing fee
we earn is based on our cost to produce VUMERITY. As the assets used to manufacture VUMERITY were classified as held for sale and transferred to
Novo in connection with the sale of the Athlone Facility, depreciation expense was removed from the manufacturing cost base, which had a negative
impact on our manufacturing fee. For a discussion of our agreements with Biogen related to VUMERITY, including the manufacturing and royalty revenue
provisions set forth therein, see the section entitled “Collaborative Arrangements—Biogen” in “Item 1—Business” in this Annual Report.
The decrease in revenue from RISPERDAL CONSTA was primarily due to a decrease of $13.0 million in manufacturing revenue, which was
primarily due to a decrease in the number of batches made available to Janssen. The decrease in royalty revenue was due to expirations of the patents
covering RISPERDAL CONSTA, which expired in the U.S. in January 2023 and in the EU in 2021. We expect revenues from RISPERDAL CONSTA to
continue to decrease as patents covering RISPERDAL CONSTA continue to expire in markets where end-market net sales of RISPERDAL CONSTA
occur. We are aware of potential generic and other competition to RISPERDAL CONSTA that may lead to reduced unit sales and increased pricing
pressure. For a discussion of our agreements with Janssen related to RISPERDAL CONSTA, including the manufacturing provisions set forth therein, see
the section entitled “Collaborative Arrangements—Janssen” in “Item 1—Business” in this Annual Report.
During the years ended December 31, 2024 and 2023, we recognized $36.6 million and $49.9 million, respectively, in manufacturing and royalty
revenue related to FAMPYRA which is included within “Other” in the table above. As of December 31, 2024, our manufacturing obligations related to
FAMPYRA concluded. Accordingly, we do not expect to recognize any revenues related to FAMPYRA going forward.
Certain of our manufacturing and royalty revenues are earned in countries outside of the U.S. and are denominated in currencies in which the
product is sold. See “Item 7A—Quantitative and Qualitative Disclosures about Market Risk” in this Annual Report for information on currency exchange
rate risk related to our revenues and “Item 1A—Risk Factors” in this Annual Report, and specifically the section entitled “Currency exchange rates may
affect revenues and expenses” for risks related to currency exchange rates.
Costs and Expenses
Cost of Goods Manufactured and Sold
Year Ended December 31,
(In millions)
2024
2023
Change
Cost of goods manufactured and sold
$
245.3 $
253.0 $
(7.7 )
59
The decrease in cost of goods manufactured and sold was primarily due to lower cost of goods manufactured for certain legacy products due to a
decrease in volumes of such products. This includes RISPERDAL CONSTA as well as products manufactured at the Athlone Facility. This decrease was
partially offset by an increase in the cost of goods sold for certain of our proprietary products due to increases in the number of units sold as discussed
above, and an increase in costs related to VIVITROL out-of-specification batches and subsequent investigation costs.
Research and Development Expenses
For each of our R&D programs, we incur both external and internal expenses. External R&D expenses include fees for clinical and preclinical
activities performed by CROs, consulting fees, and costs related to laboratory services, the purchase of drug product materials and third-party
manufacturing development activities. Internal R&D expenses include employee-related expenses, occupancy costs, depreciation and general overhead. We
track external R&D expenses for each of our development programs; however, internal R&D expenses are not tracked by individual program as they can
benefit multiple development programs or our products or technologies in general.
The following table sets forth our external R&D expenses for the years ended December 31, 2024 and 2023 relating to our then-current development
programs and our internal R&D expenses, listed by the nature of such expenses:
Year Ended December 31,
(In millions)
2024
2023
Change
External R&D expenses:
Development programs:
ALKS 2680
$
46.0 $
31.3 $
14.7
LYBALVI
18.7
15.4
3.3
Other external R&D expenses
36.6
51.7
(15.1 )
Total external R&D expenses
101.3
98.4
2.9
Internal R&D expenses:
Employee-related
114.5
128.3
(13.8 )
Occupancy
11.2
12.3
(1.1 )
Depreciation
5.7
9.6
(3.9 )
Other
12.6
22.2
(9.6 )
Total internal R&D expenses
144.0
172.4
(28.4 )
Research and development expenses
$
245.3 $
270.8 $
(25.5 )
These amounts are not necessarily predictive of future R&D expenses. In an effort to allocate our spending most effectively, we continually evaluate
our products under development based on the performance of such products in preclinical and/or clinical trials, our expectations regarding the likelihood of
their regulatory approval and our view of their future potential commercial viability, among other factors.
The increase in expenses related to ALKS 2680 was primarily due to an increase in spend related to the advancement of the development programs
for the product, including completion of our phase 1b proof-of-concept studies, initiation of our phase 2 clinical studies, Vibrance-1 and Vibrance-2 and
preparatory spend in advance of initiation of our phase 2 study for IH. The increase in expenses related to LYBALVI was primarily due to increased spend
on our pediatric studies related to the product, partially offset by decreased spend following the completion of our long-term safety and tolerability studies.
The decrease in other external R&D expenses was primarily due to identifying cost-effective resourcing options for clinical programming and outsourced
data management services and decreases in spend on activities associated with certain of our research programs. The decrease in employee-related
expenses was primarily due to a decrease in salaries and benefits related to a 10% reduction in R&D-related headcount during 2024.
Selling, General and Administrative Expenses
Year Ended December 31,
(In millions)
2024
2023
Change
Selling and marketing expense
$
446.2 $
490.2 $
(44.0 )
General and administrative expense
199.0
199.6
(0.6 )
Selling, general and administrative expense
$
645.2 $
689.8 $
(44.6 )
60
The decrease in selling and marketing expense was primarily due to a $34.6 million decrease in marketing expense related primarily to decreased
media spend and free goods, a $7.1 million decrease in professional services, primarily due to the decrease in media spend, and a $3.6 million decrease in
employee related expenses, primarily due to a 7% decrease in sales and marketing headcount.
Amortization of Acquired Intangible Assets
Year Ended
December 31,
(In millions)
2024
2023
Change
Amortization of acquired intangible assets
$
1.1 $
35.7 $
(34.6 )
Our amortizable intangible assets primarily consisted of technology and collaborative arrangements acquired as part of the acquisition of Elan Drug
Technologies (“EDT”) in September 2011. These intangible assets were amortized over 12 to 13 years 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, and became fully
amortized during 2024.
Other Income, Net
Year Ended December 31,
(In millions)
2024
2023
Change
Interest income
$
42.5 $
30.9 $
11.6
Interest expense
(22.6 )
(23.0 )
0.4
Other income (expense), net
3.2
(0.5 )
3.7
Total other income, net
$
23.1 $
7.4 $
15.7
Interest income consists of interest earned on our cash and available-for-sale investments. The increase in interest income was due to an increase in
our cash and investments and increases in interest rates due to the rising interest rate environment. Interest expense consists of interest incurred on our
previously outstanding term loans scheduled to become due in 2026 (the “Former Term Loans”) under our former amended and restated credit agreement
(the “Former Credit Agreement”), which we prepaid in full and terminated on December 19, 2024.
The increase in other income (expense), net was primarily due to the gain on the sale of the Athlone Facility of approximately $1.5 million,
following the completion of the sale in May 2024.
Income Tax Provision (Benefit)
Year Ended December 31,
(In millions)
2024
2023
Change
Income tax provision (benefit)
$
71.6 $
(97.6 ) $
169.2
The income tax provision in 2024 was primarily due to taxes on income earned in Ireland. The income tax benefit in 2023 was primarily attributable
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. Our effective tax rate during the year ended December 31, 2024 was 16.1%, which exceeds the Irish statutory tax rate of 12.5%, primarily due
to non-deductible expenses and income that was taxable at rates higher than the Irish statutory tax rate. The new corporate minimum tax rate of 15.0% did
not have a material impact on our business in 2024.
Cumulative unremitted earnings of U.S. subsidiaries totaled approximately $933.5 million as of December 31, 2024. In the event of a repatriation of
those earnings in the form of dividends or otherwise, we may be liable for income taxes, subject to adjustment, if any, for foreign tax credits and foreign
withholding taxes payable to foreign tax authorities. We estimate that approximately $72.0 million of income taxes would be payable on the repatriation of
the unremitted earnings to Ireland.
As of December 31, 2024, we had $393.9 million of Irish NOL carryforwards, $14.1 million of U.S. federal NOL carryforwards, $43.2 million of
state NOL carryforwards and $34.0 million of state tax credits which will either expire on various dates through 2039 or can be carried forward
indefinitely. These loss and credit carryforwards are available to reduce certain future Irish and foreign taxable income and tax. These loss and credit
carryforwards are subject to review and possible adjustment by the appropriate taxing authorities, and may be subject to limitations based upon changes in
the ownership of our ordinary shares. Included within these loss and credit carryforwards are $14.1 million of U.S. federal NOL carryforwards and $5.8
million of state NOL
61
carryforwards, acquired as part of the acquisition of Rodin Therapeutics, Inc. (“Rodin”) in November 2019, each of which are subject to a $0.5 million
annual limitation.
Liquidity and Capital Resources
Our financial condition is summarized as follows:
December 31, 2024
December 31, 2023
(In millions)
U.S.
Ireland
Total
U.S.
Ireland
Total
Cash and cash equivalents
$
70.3 $
220.8 $
291.1 $
317.8 $
139.7 $
457.5
Investments—short-term
203.6
256.9
460.5
187.6
128.4
316.0
Investments—long-term
24.6
48.5
73.1
18.0
21.9
39.9
Total cash and investments
$
298.5 $
526.2 $
824.7 $
523.4 $
290.0 $
813.4
Outstanding borrowings—short and long-term
$
— $
— $
— $
290.7 $
— $
290.7
At December 31, 2024, our investments consisted of the following:
Gross
Amortized
Unrealized
Allowance for
Estimated
(In millions)
Cost
Gains
Losses
Credit Losses
Fair Value
Investments—short-term available-for-sale
$
459.1 $
1.5 $
(0.1 ) $
— $
460.5
Investments—long-term available-for-sale
73.3
—
(0.3 )
—
73.0
Investments—long-term held-to-maturity
0.1
—
—
—
0.1
Total
$
532.5 $
1.5 $
(0.4 ) $
— $
533.6
Sources and Uses of Cash
We generated $439.1 million and $401.4 million of cash from operating activities during the years ended December 31, 2024 and 2023,
respectively. In December 2024, we prepaid our previously outstanding long-term debt without penalty in the amount of $289.5 million and, during the
course of 2024, repurchased approximately $200.0 million of our ordinary shares. We expect that our existing cash, cash equivalents and investments will
be sufficient to finance our anticipated working capital and other cash requirements, including capital expenditures, for at least the twelve months following
the date from which our financial statements were issued. Subject to market conditions, interest rates and other factors, we may pursue opportunities to
obtain financing in the future, including debt and equity offerings, corporate collaborations, bank borrowings, arrangements relating to assets or other
financing methods or structures.
Our investment objectives are, first, to preserve liquidity and conserve capital and, second, to generate investment income. We mitigate credit risk in
our cash reserves by maintaining a well-diversified portfolio that limits the amount of investment exposure as to institution, maturity and investment type.
Our available-for-sale investments consist primarily of short and long-term U.S. government and agency debt securities and corporate debt securities. Our
held-to-maturity investments consist of investments that are held as collateral under certain letters of credit related to certain of our lease agreements.
We classify available-for-sale investments in an unrealized loss position that do not mature within 12 months as long-term investments. We have the
intent and ability to hold these investments until recovery, which may be at maturity, and it is more-likely-than-not that we would not be required to sell
these securities before recovery of their amortized cost.
We have no off-balance sheet arrangements that are reasonably likely to have a material effect on our financial condition, changes in financial
condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources in the next 12 months. In connection with our
acquisition of Rodin, we may become obligated to make up to $825.0 million in future milestone payments to the former shareholders of Rodin, $200.0
million of which would be triggered upon achievement of certain specified clinical milestones, $300.0 million of which would be triggered by the
achievement of certain regulatory milestones and $325.0 million of which would be triggered upon the attainment of certain sales thresholds. At December
31, 2024, we had not recorded a liability related to these milestone payments as none of the future events that would trigger a milestone payment were
considered probable of occurring.
62
Information about our cash flows, by category, is presented in the accompanying consolidated statements of cash flows. The discussion of our cash
flows that follows does not include the impact of any adjustments to remove discontinued operations and is stated on a total company consolidated basis.
The following table summarizes our cash flows for the years ended December 31, 2024 and 2023:
Year Ended December 31,
(In millions)
2024
2023
Cash and cash equivalents, beginning of period
$
457.5 $
292.5
Cash flows provided by operating activities
439.1
401.4
Cash flows (used in) provided by investing activities
(111.3 )
53.3
Cash flows used in financing activities
(494.1 )
(289.7 )
Cash and cash equivalents, end of period
$
291.2 $
457.5
Operating Activities
Cash flows provided by operating activities represent the cash receipts and disbursements related to all of our activities other than investing and
financing activities. Operating cash flow is derived by adjusting our net income (loss) for non-cash operating items such as depreciation, amortization and
share-based compensation and changes in operating assets and liabilities, which reflect timing differences between the receipt and payment of cash
associated with transactions and when they are recognized in our results of operations.
Cash flows provided by operating activities during 2024 primarily consisted of net income of $367.1 million, adjusted for non-cash items, including
share-based compensation of $96.6 million and depreciation and amortization of $28.5 million and deferred income taxes of $40.5 million.
Cash flows provided by operating activities during 2023 primarily consisted of net income of $355.8 million, adjusted for non-cash items, including
share-based compensation of $100.9 million and depreciation and amortization of $74.9 million, partially offset by changes in working capital of $36.7
million and deferred income taxes of $99.9 million. During 2023, net income included receipt of $195.4 million from Janssen, inclusive of $8.1 million in
late-payment interest, related to 2022 U.S. net sales of the long-acting INVEGA products following the successful outcome of the arbitration proceedings
in respect of such products.
Investing Activities
Cash flows used in investing activities during 2024 primarily consisted of $176.2 million in net purchases of investments and the purchase of $33.5
million of property, plant and equipment. These outflows were offset by proceeds from the sale of the Athlone Facility and related business of $97.9
million. Cash flows provided by investing activities during 2023 primarily consisted of $101.1 million in net sales of investments and offset by the
purchase of $48.0 million of property, plant and equipment.
We expect to spend approximately $45.0 million to $50.0 million during the year ending December 31, 2025 for capital expenditures. We continue
to evaluate our manufacturing capacity based on expectations of demand for the products that we manufacture and will continue to record such amounts
within construction in progress until such time as the underlying assets are placed into service, or we determine we have sufficient existing capacity and the
assets are no longer required, at which time we would recognize an impairment charge. We continue to periodically evaluate whether facts and
circumstances indicate that the carrying value of these long-lived assets to be held and used may not be recoverable.
Financing Activities
Cash flows used in financing activities during 2024 primarily related to the prepayment of our previously outstanding long-term debt in the full
amount of $289.5 million, payment for the repurchase of our ordinary shares and related expenses in the amount of $200.3 million, and $29.6 million of
employee taxes paid related to net share settlements of equity awards, partially offset by $27.6 million of cash that we received upon exercises of employee
stock options. Cash flows used in financing activities during 2023 primarily related to $275.0 million in cash distributed to Mural Oncology plc in
connection with the Separation and $28.5 million of employee taxes paid related to net share settlements of equity awards, partially offset by $16.8 million
of cash that we received upon exercises of employee stock options.
Debt
In December 2024, we prepaid in full all Former Term Loans under the Former Credit Agreement for a total of $289.5 million. The Company did
not incur any early termination penalties in connection with the termination of the Former Credit Agreement (other than customary breakage costs). All
liens on the collateral securing the obligations under the Former Credit Agreement were released in connection with the termination. Such prepayment was
accounted for as a debt extinguishment. See Note 12, Long-Term Debt, in the “Notes to Consolidated Financial Statements” in this Annual Report for
additional discussion related to our Former Term Loans.
63
Discontinued Operations
Net loss from discontinued operations consists of the results of our former oncology business and is reported as a separate component of income.
For additional information, see Note 3, Discontinued Operations, in the “Notes to Consolidated Financial Statements” in this Annual Report.
Critical Accounting Estimates
Our consolidated financial statements are prepared in accordance with GAAP. In connection with the preparation of our financial statements, we are
required to make assumptions and estimates about future events, and apply judgments based on historical experience, current trends and other factors that
management believes to be relevant at the time our consolidated financial statements are prepared. On a regular basis, we review these accounting policies,
assumptions, estimates and judgments to ensure that our financial statements are presented fairly and in accordance with GAAP. However, because future
events and their effects cannot be determined with certainty, actual results could differ from our assumptions and estimates, and such differences could be
material.
Our significant accounting policies are discussed in Note 2, Summary of Significant Accounting Policies, of the “Notes to Consolidated Financial
Statements” in this Annual Report. We believe that the following accounting estimates are the most critical to aid in fully understanding and evaluating our
reported financial results, and they require our most difficult, subjective or complex judgments, resulting from the need to make estimates about the effects
of matters that are inherently uncertain. We have reviewed these critical accounting estimates and related disclosures with the audit and risk committee of
our board of directors.
Revenue from Contracts with Customers
We recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we
expect to receive in exchange for those goods or services. We recognize revenue following the five-step model prescribed under Financial Accounting
Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers, (“Topic 606”): (i) identify
contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price
to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligations.
Product Sales, Net
Our product sales, net consist of sales in the U.S. of VIVITROL, ARISTADA, ARISTADA INITIO and LYBALVI, primarily to wholesalers,
specialty distributors and pharmacies. Product sales, net are recognized when the customer obtains control of the product, which is when the product has
been received by the customer.
Revenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with
our customers, healthcare providers or payers. Our 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 our estimates. If actual results vary, we adjust these
estimates, which could have an effect on earnings in the period of adjustment. The following are our significant categories of sales discounts and
allowances:
•
Medicaid Rebates—we record 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. We rebate individual U.S. states for all eligible units purchased
under the Medicaid program based on a rebate per unit calculation, which is based on our average manufacturer prices. We estimate expected
unit sales to individuals covered by Medicaid and rebates per unit under the Medicaid program and adjust our rebate accrual based on actual
unit sales and rebates per unit and changes in trends in Medicaid utilization. In 2024, actual Medicaid utilization rates related to VIVITROL
were lower than original estimates, due, in part, to $8.7 million in actual credits received in the fourth quarter of 2024 from certain states
related to duplicate Medicaid billings. Medicaid rebates for our other products have not differed materially from our estimates;
•
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 us 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 and is based on actual and expected utilization
of these programs. Chargebacks could exceed historical experience and our estimates of future participation in these programs. To date,
actual chargebacks have not differed materially from our estimates;
64
•
Product Discounts—cash consideration, including sales incentives, given by us 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 and to date, actual product discounts have not differed materially from our estimates;
•
Product Returns—we record an estimate for product returns at the time our customers take control of our product. We estimate this liability
using the expected returns of product sold based on our 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.
Actual product returns have not differed materially from our estimates; and
•
Medicare Part D—we record 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 for reimbursement of prescription plan sponsors for the portion of out-of-pocket expenses not covered under their Medicare
plans. Actual Medicaid Part D rebates have not differed materially from our estimates.
A rollforward of our provisions for sales and allowances is as follows:
(In millions)
Contractual
Adjustments
Discounts
Product Returns
Other
Total
Balance, December 31, 2022
$
226.7 $
26.2 $
29.7 $
7.9 $
290.5
Provision:
Current year
509.7
326.9
33.4
71.5
941.5
Prior year
(8.8 )
—
2.8
—
(6.0 )
Total
500.9
326.9
36.2
71.5
935.5
Payments and credits related to:
Current year sales
(308.4 )
(293.8 )
—
(56.2 )
(658.4 )
Prior year sales
(184.8 )
(30.6 )
(24.8 )
(13.0 )
(253.2 )
Total
(493.2 )
(324.4 )
(24.8 )
(69.2 )
(911.6 )
Balance, December 31, 2023
$
234.4 $
28.7 $
41.1 $
10.2 $
314.4
Provision:
Current year
557.7
386.6
28.6
87.4
1,060.3
Prior year
(20.6 )
—
(3.7 )
—
(24.3 )
Total
537.1
386.6
24.9
87.4
1,036.0
Payments and credits related to:
Current year sales
(369.9 )
(353.6 )
—
(70.8 )
(794.3 )
Prior year sales
(172.6 )
(18.1 )
(15.5 )
(13.5 )
(219.7 )
Total
(542.5 )
(371.7 )
(15.5 )
(84.3 )
(1,014.0 )
Balance, December 31, 2024
$
229.0 $
43.6 $
50.5 $
13.3 $
336.4
(1)
“Contractual Adjustments” include “Medicaid Rebates” and “Medicare Part D” accruals
(2)
“Discounts” include “Chargebacks” and “Product Discounts”
Manufacturing Revenue
We recognize manufacturing revenues from the sale of products we manufacture for resale by our licensees. Substantially all of our manufacturing
revenues are recognized at a point in time when control of the product passes to the licensee. The sales price for certain of our manufacturing revenues is
based on the end-market sales price earned by our licensees. As end-market sales generally occur after we have recorded manufacturing revenue, we
estimate the sales price for such products based on information supplied to us by our licensees, our 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 our actual and estimated manufacturing revenues have not been
material to date.
Royalty Revenue
We recognize royalty revenues related to the sale by our licensees of products that incorporate our technology. All of our royalties qualify for the
sales-and-usage exemption under Topic 606 as (i) such royalties are based strictly on the sales-and-usage by
(1)
(2)
65
the licensee; and (ii) a license of IP is the sole or predominant item to which such royalties relate. Based on this exemption, such royalties are earned in the
period the products are sold by our licensees and we have a present right to payment.
Certain of our royalty revenues are recognized based on information supplied to us by our 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 our actual and estimated royalty revenues have not been material to date.
Discontinued operations
We determined that the separation of our former oncology business, which was completed on November 15, 2023, represented a disposal plan that
met the criteria for classification of the oncology business as a discontinued operation in accordance with ASC 205-20, Discontinued Operations.
Accordingly, the accompanying consolidated financial statements for all periods have been updated to present the assets and liabilities associated with the
oncology business separately as discontinued operations on the consolidated balance sheet and the results of such discontinued operations reported as a
separate component of income in the consolidated statements of operations and comprehensive income (loss).
For additional information related to discontinued operations, see Note 3, Discontinued Operations, in our “Notes to Consolidated Financial
Statements” in this Annual Report.
Impairment of Long-Lived Assets
Long-lived assets, other than goodwill which is separately tested for impairment, are evaluated for impairment whenever events or changes in
circumstances indicate the carrying value of an asset may not be recoverable. When evaluating long-lived assets for potential impairment, we first compare
the carrying value of the asset to the asset’s estimated future cash flows (undiscounted and without interest charges). If the estimated future cash flows are
less than the carrying value of the asset, we calculate an impairment loss. The impairment loss calculation compares the carrying value of the asset to the
asset’s estimated fair value, which may be based on estimated future cash flows (discounted and with interest charges). We recognize an impairment loss if
the amount of the asset’s carrying value exceeds the asset’s estimated fair value. If we recognize an impairment loss, the adjusted carrying amount of the
asset becomes its new cost basis. For a depreciable long-lived asset, the new cost basis will be depreciated over the remaining useful life of that asset.
When reviewing long-lived assets for impairment, we group long-lived assets with other assets and liabilities at the lowest level for which
identifiable cash flows are largely independent of the cash flows of other assets and liabilities. Our impairment loss calculations contain uncertainties
because they require management to make assumptions and to apply judgment to estimate future cash flows and asset fair values, including forecasting
useful lives of the assets and selecting the discount rate that reflects the risk inherent in future cash flows.
Goodwill
We evaluate goodwill for impairment for our reporting units annually, as of October 31, and whenever events or changes in circumstances indicate
the carrying value of the reporting units may not be recoverable. A reporting unit is an operating segment, as defined by GAAP, or a component of an
operating segment. A component of an operating segment is a reporting unit if the component constitutes a business for which discrete financial
information is available and is reviewed by management. Two or more components of an operating segment may be aggregated and deemed a single
reporting unit for goodwill impairment testing purposes if the components have similar economic characteristics. As of December 31, 2024, we have one
operating segment and two reporting units. Our goodwill, which solely relates to the Business Combination, has been assigned to one reporting unit which
consists of the former EDT business.
We have the option to first assess qualitative factors to determine whether it is necessary to perform a quantitative impairment test. If we elect this
option and determine, as a result of the qualitative assessment, that it is more likely than not that the fair value of a reporting unit is less than its carrying
amount, the quantitative impairment test is required; otherwise, no further testing is required. Among other relevant events and circumstances that affect the
fair value of reporting units, we consider individual factors, such as microeconomic conditions, changes in the industry and the markets in which we
operate as well as historical and expected future financial performance. Alternatively, we may elect to not first assess qualitative factors and instead
immediately perform the quantitative impairment test.
On October 31, 2024, we elected to perform a qualitative impairment test and determined that, based on the weight of all available evidence, the fair
value of the reporting unit more-likely-than-not exceeded its carrying value.
66
Valuation of Deferred Tax Assets
We evaluate the need for deferred tax asset valuation allowances based on a more-likely-than-not standard. The ability to realize deferred tax assets
depends on the ability to generate sufficient taxable income within the carryback or carryforward periods provided for in the tax law for each applicable tax
jurisdiction. We consider the following possible sources of taxable income when assessing the realization of deferred tax assets:
•
future reversals of existing taxable temporary differences;
•
future taxable income exclusive of reversing temporary differences and carryforwards;
•
taxable income in prior carryback years; and
•
tax-planning strategies.
The assessment regarding whether a valuation allowance is required or should be adjusted also considers all available positive and negative evidence
factors including, but not limited to:
•
nature, frequency and severity of recent losses;
•
duration of statutory carryforward periods;
•
historical experience with tax attributes expiring unused; and
•
near- and medium-term financial outlook.
We utilize a rolling three years of actual and current year anticipated results as the primary measures of cumulative income (losses) in recent years.
For additional information related to our assessment of our valuation allowance, see Note 17, Income Taxes in the “Notes to Consolidated Financial
Statements” in this Annual Report.
The evaluation of deferred tax assets requires judgment in assessing the likely future tax consequences of events that have been recognized in our
financial statements or tax returns and future profitability. Our accounting for deferred tax consequences represents our best estimate of those future events.
Changes in our current estimates, due to unanticipated events or otherwise, could have a material effect on our financial condition and results of operations.
For information related to risks surrounding our deferred tax assets, see “Item 1A—Risk Factors” in this Annual Report and specifically the section entitled
“Our deferred tax assets may not be realized.”
Recent Accounting Pronouncements
See Note 2, Summary of Significant Accounting Policies, “New Accounting Pronouncements” in our “Notes to Consolidated Financial Statements”
in this Annual Report for discussion, if any, of new accounting standards.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
We hold securities in our investment portfolio that are sensitive to market risks. Our securities with fixed interest rates may have their market value
adversely impacted by a rise in interest rates, while floating rate securities may produce less income than expected if interest rates fall. Due in part to these
factors, our future investment income may fall short of expectations due to a fall in interest rates or we may suffer losses in principal if we are forced to sell
securities that decline in market value due to changes in interest rates. However, because we classify our investments in debt securities as available-for-
sale, no gains or losses are recognized due to changes in interest rates unless such securities are sold prior to maturity or declines in fair value are
determined to be other-than-temporary. Should interest rates fluctuate by 10%, our interest income would change by an immaterial amount over an annual
period. We do not believe that we have a material exposure to interest rate risk as our investment policies specify credit quality standards for our
investments and limit the amount of credit exposure from any single issue, issuer or type of investment.
We do not believe our exposure to liquidity and credit risk to be significant as approximately 41% and 59% of our investments at December 31,
2024 are 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. We have the intent and ability to hold these securities until recovery, which may be at maturity.
67
Currency Exchange Rate Risk
Manufacturing and royalty revenues that we receive on certain of our products and services are a percentage of the net sales made by our licensees,
and a portion of these sales are made in countries outside the U.S. and are denominated in currencies in which the product is sold, which is predominantly
the euro. The manufacturing and royalty payments on these non-U.S. sales are calculated initially in the currency in which the sale is made and are then
converted into USD to determine the amount that our licensees pay us for manufacturing and royalty revenues. Fluctuations in the exchange ratio of the
USD and these non-U.S. currencies will have the effect of increasing or decreasing our revenues even if there is a constant amount of sales in non-U.S.
currencies. For example, if the USD weakens against a non-U.S. currency, then our revenues will increase given a constant amount of sales in such non-
U.S. currency. For the year ended December 31, 2024, an average 10% strengthening of the USD relative to the currencies in which these products are sold
would have resulted in revenues being reduced by approximately $8.9 million, as compared to a reduction in revenues of approximately $10.3 million for
the year ended December 31, 2023.
We incur significant operating costs in Ireland and face exposure to changes in the exchange ratio of the USD and the euro arising from expenses
and payables at our Irish operations that are settled in euro. The impact of changes in the exchange ratio of the USD and the euro on our USD-denominated
revenues earned in countries other than the U.S. is partially offset by the opposite impact of changes in the exchange ratio of the USD and the euro on
operating expenses and payables incurred at our Irish operations that are settled in euro. For the year ended December 31, 2024, an average 10% weakening
in the USD relative to the euro would have resulted in an increase to our expenses denominated in euro of approximately $3.9 million, as compared to an
increase in our expenses of approximately $7.7 million for the year ended December 31, 2023.
Item 8. Financial Statements and Supplementary Data
Selected Quarterly Financial Data (unaudited)
First
Quarter
Second
Quarter
Third
Quarter
Fourth
Quarter
Total
2024
(In thousands, except per share data)
Year Ended December 31, 2024
Total revenues
$
350,372 $
399,131 $
378,143 $
429,986 $
1,557,632
Total operating expenses
307,063
289,248
273,387
267,298
1,136,996
Operating income from continuing operations
43,309
109,883
104,756
162,688
420,636
Net income from continuing operations
$
38,948 $
94,658 $
92,795 $
145,737 $
372,138
Net (loss) income from discontinued operations
(2,120 )
(3,300 )
(414 )
766
(5,068 )
Net income
$
36,828 $
91,358 $
92,381 $
146,503 $
367,070
Earnings (loss) per share—basic:
From continuing operations
$
0.23 $
0.56 $
0.57 $
0.90 $
2.24
From discontinued operations
$
(0.01 ) $
(0.02 ) $
(0.00 ) $
0.00 $
(0.03 )
From net income
$
0.22 $
0.54 $
0.57 $
0.90 $
2.21
Earnings (loss) per share—diluted:
From continuing operations
$
0.23 $
0.55 $
0.56 $
0.88 $
2.19
From discontinued operations
$
(0.01 ) $
(0.02 ) $
(0.00 ) $
0.00 $
(0.03 )
From net income
$
0.21 $
0.53 $
0.55 $
0.88 $
2.16
68
First
Quarter
Second
Quarter
Third
Quarter
Fourth
Quarter
Total
2023
(In thousands, except per share data)
Year Ended December 31, 2023
Total revenues from continuing operations
$
287,595 $
617,397 $
380,938 $
377,475 $
1,663,405
Total operating expenses from continuing operations
298,567
336,128
291,744
322,844
1,249,283
Operating (loss) income from continuing operations
(10,972 )
281,269
89,194
54,631
414,122
Net (loss) income from continuing operations
$
(12,050 ) $
279,101 $
91,554 $
160,552 $
519,157
Net loss from discontinued operations
(29,795 )
(42,036 )
(43,796 )
(47,773 )
(163,400 )
Net (loss) income
$
(41,845 ) $
237,065 $
47,758 $
112,779 $
355,757
(Loss) earnings per share—basic:
From continuing operations
$
(0.07 ) $
1.68 $
0.55 $
0.96 $
3.12
From discontinued operations
$
(0.18 ) $
(0.25 ) $
(0.26 ) $
(0.29 ) $
(0.98 )
From net (loss) income
$
(0.25 ) $
1.43 $
0.29 $
0.68 $
2.14
(Loss) earnings per share—diluted:
From continuing operations
$
(0.07 ) $
1.63 $
0.53 $
0.94 $
3.06
From discontinued operations
$
(0.18 ) $
(0.25 ) $
(0.25 ) $
(0.28 ) $
(0.96 )
From net (loss) income
$
(0.25 ) $
1.38 $
0.28 $
0.66 $
2.10
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Not applicable.
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, 2024. 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, 2024 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;
69
•
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, 2024. 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, 2024, our internal control over financial reporting was effective.
The effectiveness of our internal control over financial reporting as of December 31, 2024 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
During the three months ended December 31, 2024, no officer (as defined in Rule 16a-1(f) under the Exchange Act) or director of the Company
adopted, modified or terminated a contract, instruction or written plan for the purchase or sale of securities of the Company that were intended to satisfy the
affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act or a trading plan not intended to satisfy the affirmative defense conditions of
Rule 10b5-1(c) under the Exchange Act.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
70
PART III
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this item is incorporated herein by reference to our definitive proxy statement for our 2025 annual general meeting of
shareholders. We expect this information will be provided under sections of the proxy statement entitled “Proposal 1—Election of Directors,” “The Role of
the Board and Its Committees,” “Executive Officers,” “Other Corporate Governance Matters” and “Board Nominations, Evaluations and Refreshment”
and, if required, “Delinquent Section 16(a) Reports”.
Item 11. Executive Compensation
The information required by this item (excluding, for clarity, the information required by Item 402(v) of Regulation S-K) is incorporated herein by
reference to our definitive proxy statement for our 2025 annual general meeting of shareholders. We expect this information will be provided under
sections of the proxy statement entitled “The Role of the Board and Its Committees,” “Director Compensation,” “Executive Compensation—Compensation
Discussion and Analysis,” “Executive Compensation Tables,” “Additional Compensation Information,” “Compensation Committee Report” and “Pay
Ratio”.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this item is incorporated herein by reference to our definitive proxy statement for our 2025 annual general meeting of
shareholders. We expect this information will be provided under sections of the proxy statement entitled “Ownership of the Company’s Ordinary Shares”
and “Equity Compensation Plan Information”.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item is incorporated herein by reference to our definitive proxy statement for our 2025 annual general meeting of
shareholders. We expect this information will be provided under sections of the proxy statement entitled “Certain Relationships and Related Party
Transactions” and “The Board of Directors”.
Item 14. Principal Accounting Fees and Services
The information required by this item is incorporated herein by reference to our definitive proxy statement for our 2025 annual general meeting of
shareholders. We expect this information will be provided under a section of the proxy statement entitled “Audit Fees”.
71
PART IV
Item 15. Exhibits and Financial 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-3
Consolidated Statements of Operations and Comprehensive Income (Loss)
F-4
Consolidated Statements of Shareholders’ Equity
F-5
Consolidated Statements of Cash Flows
F-6
Notes to the Consolidated Financial Statements
F-7
(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
2.2 ** §
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.
Exhibit 3.1 to the Alkermes plc
Quarterly Report on Form 10-Q
(File No. 001-35299)
May 1, 2024
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
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
72
Incorporated by reference herein
Exhibit No.
Description of Exhibit
Form
Date
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. II (assigned to Alkermes, Inc. in
July 2006), effective as of July 1, 2018.
Exhibit 10.11 to the Alkermes plc
Quarterly Report on Form 10-Q
(File No. 011-35299)
October 23, 2018
73
Incorporated by reference herein
Exhibit No.
Description of Exhibit
Form
Date
10.5 *
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
10.5A *
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
10.6 **
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
10.6A
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
10.6B **
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
10.7 *
License and Collaboration Agreement, dated November 27, 2017, by and
between Alkermes Pharma Ireland Limited and Biogen International
GmbH (as successor to Biogen Swiss Manufacturing GmbH).
Exhibit 10.10 to the Alkermes plc
Annual Report on Form 10-K
(File No. 011-35299)
February 16, 2018
10.7A *
First Amendment to License and Collaboration Agreement between
Alkermes Pharma Ireland Limited and Biogen International GmbH (as
successor to Biogen Swiss Manufacturing GmbH), effective as of October
3, 2018.
Exhibit 10.12 to the Alkermes plc
Quarterly Report on Form 10-Q
(File No. 011-35299)
October 23, 2018
10.7B
Second Amendment to License and Collaboration Agreement between
Alkermes Pharma Ireland Limited and Biogen International GmbH (as
successor to Biogen Swiss Manufacturing GmbH), effective as of January
31, 2019.
Exhibit 10.1 to the Alkermes plc
Quarterly Report on Form 10-Q
(File No. 011-35299)
April 25, 2019
10.7C **
Third Amendment to License and Collaboration Agreement between
Alkermes Pharma Ireland Limited and Biogen International GmbH (as
successor to Biogen Swiss Manufacturing GmbH), effective as of October
30, 2019.
Exhibit 10.10.3 to the Alkermes
plc Annual Report on Form 10-K
(File No. 011-35299)
February 13, 2020
10.7D **
Fourth Amendment to License and Collaboration Agreement between
Alkermes Pharma Ireland Limited and Biogen International GmbH (as
successor to Biogen Swiss Manufacturing GmbH), effective as of August
25, 2022.
Exhibit 10.1 to the Alkermes plc
Quarterly Report on Form 10-Q
(File No. 011-35299)
November 2, 2022
10.7E **
Fifth Amendment to License and Collaboration Agreement between
Alkermes Pharma Ireland Limited and Biogen International GmbH (as
successor to Biogen Swiss Manufacturing GmbH), effective as of June 7,
2024.
Exhibit 10.1 to the Alkermes plc
Quarterly Report on Form 10-Q
(File No. 011-35299)
July 24, 2024
10.8
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
10.8A
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
10.8B
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
74
Incorporated by reference herein
Exhibit No.
Description of Exhibit
Form
Date
10.9 **
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
10.10 §
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
10.11 ** §
Asset Purchase Agreement, dated December 13, 2023, by and between
Alkermes Pharma Ireland Limited, Novo Nordisk Production Ireland
Limited and Novo Nordisk A/S.
Exhibit 10.16 to the Alkermes plc
Annual Report on Form 10-K
(File No. 001-35299)
February 21, 2024
10.12 †
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
10.12A †
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
10.12B †
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
10.13 †
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 Blair C. Jackson.
Exhibit 10.3 to the Alkermes, Inc.
Quarterly Report on Form 10-Q
(File No. 001-14131)
February 11, 2008
10.13A †
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
10.14 †
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
10.14A†
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
10.14B †
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
10.15 †
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
10.16 †
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
10.17†
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
10.17A †
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
10.17B †
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
April 28, 2016
75
Incorporated by reference herein
Exhibit No.
Description of Exhibit
Form
Date
March 31, 2016 (File No. 001-
35299)
10.17C †
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
10.17D †
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
10.17E †
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
10.17F †
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
10.17G †
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
10.18†
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
10.18A †
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
10.18B †
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
10.18C †
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
10.18D †
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
10.18E †
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
10.19 †
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)
May 31, 2024
10.19A †
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
10.19B †
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
10.19C †
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
76
Incorporated by reference herein
Exhibit No.
Description of Exhibit
Form
Date
10.19D †
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
10.19E †
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
10.19F †
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
10.19G †
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
10.19H †
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
10.19I †
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
10.19J †
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
10.19K †
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
10.19L †
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
10.19M †
Form of Restricted Stock Unit (Performance-Vesting) Award Certificate
(rev. 2024) for Reporting Officers under the Alkermes plc 2018 Stock
Option and Incentive Plan, as amended.
Exhibit 10.25M to the Alkermes
plc Annual Report on Form 10-K
(File No. 001-35299)
February 21, 2024
10.19N †
Form of Restricted Stock Unit (Performance-Vesting) Award Certificate
(rev. 2024) under the Alkermes plc 2018 Stock Option and Incentive Plan,
as amended.
Exhibit 10.25N to the Alkermes
plc Annual Report on Form 10-K
(File No. 001-35299)
February 21, 2024
10.19O †
Form of Non-Employee Director Non-Qualified Stock Option Award
Certificate (rev. 2024) under the Alkermes plc 2018 Stock Option and
Incentive Plan, as amended.
Exhibit 10.2A to the Alkermes plc
Quarterly Report on Form 10-Q
(File No. 001-35299)
July 24, 2024
10.19P †
Form of Non-Employee Director Restricted Stock Unit Award (Time-
Vesting) Award Certificate (rev. 2024) under the Alkermes plc 2018
Stock Option and Incentive Plan, as amended.
Exhibit 10.2A to the Alkermes plc
Quarterly Report on Form 10-Q
(File No. 001-35299)
July 24, 2024
19.1 #
Alkermes plc Insider Trading Policy.
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.
77
Incorporated by reference herein
Exhibit No.
Description of Exhibit
Form
Date
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.
Exhibit 97 to the Alkermes plc
Annual Report on Form 10-K
(File No. 001-35299)
February 21, 2024
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.
Item 16. Form 10-K Summary
None.
78
SIGNATURES
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 12, 2025
POWER OF ATTORNEY
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 Blair C. Jackson, and each of
them, his true and lawful attorney-in-fact, with full power of substitution, for him in any and all capacities, to execute and cause to be filed with the
Securities and Exchange Commission any and all amendments to this Annual Report, with exhibits thereto and other documents in connection therewith,
and hereby ratifies and confirms all that said attorney-in-fact or his substitute or substitutes may do or cause to be done by virtue hereof.
Signature
Title
Date
/s/ Richard F. Pops
Richard F. Pops
Chairman and Chief Executive Officer (Principal Executive Officer)
February 12, 2025
/s/ Blair C. Jackson
Blair C. Jackson
Executive Vice President, Chief Operating Officer (Interim Principal
Financial Officer)
February 12, 2025
/s/ Samuel J. Parisi
Samuel J. Parisi
Vice President, Finance (Interim Principal Accounting Officer)
February 12, 2025
/s/ Emily Peterson Alva
Emily Peterson Alva
Director
February 12, 2025
/s/ Shane M. Cooke
Shane M. Cooke
Director
February 12, 2025
/s/ David A. Daglio, Jr.
Director
February 12, 2025
David A. Daglio, Jr.
/s/ Richard B. Gaynor
Richard B. Gaynor
Director
February 12, 2025
/s/ Cato T. Laurencin
Director
February 12, 2025
Cato T. Laurencin
/s/ Nancy S. Lurker
Nancy S. Lurker
Director
February 12, 2025
/s/ Brian P. McKeon
Brian P. McKeon
Director
February 12, 2025
/s/ Nancy L. Snyderman
Nancy L. Snyderman
Director
February 12, 2025
/s/ Frank Anders Wilson
Frank Anders Wilson
Director
February 12, 2025
/s/ Christopher I. Wright
Christopher I. Wright
Director
February 12, 2025
F-1
Report of Independent Registered 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,
2024 and 2023, 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, 2024, 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, 2024,
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, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period
ended December 31, 2024 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, 2024, 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-2
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 matter communicated below is a matter arising from the current period audit of the consolidated financial statements that
was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to
the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of
critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by
communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to
which it relates.
Rebate Accruals – Medicaid Drug Rebate Program
As described in Notes 2 and 11 to the consolidated financial statements, the Company’s revenues from product sales are recorded net of
reserves established for applicable discounts and allowances that are offered within contracts with the Company’s customers, health care
providers or payers. The Company records accruals for rebates to U.S. 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, 2024, accrued Medicaid
rebates were $202.0 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 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 12, 2025
We have served as the Company’s auditor since 2007.
F-3
ALKERMES PLC AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
December 31, 2024 and 2023
December 31, 2024
December 31, 2023
(In thousands, except share and per share amounts)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
291,146 $
457,469
Investments—short-term
460,522
316,022
Receivables, net
384,528
332,477
Inventory
182,887
186,406
Prepaid expenses and other current assets
91,282
98,166
Contract assets
4,990
706
Assets held for sale
—
94,260
Total current assets
1,415,355
1,485,506
PROPERTY, PLANT AND EQUIPMENT, NET
227,564
226,943
INVESTMENTS—LONG-TERM
73,148
39,887
RIGHT-OF-USE ASSETS
84,245
91,460
INTANGIBLE ASSETS, NET AND GOODWILL
83,917
85,018
DEFERRED TAX ASSETS
154,835
195,888
OTHER ASSETS
16,503
11,521
TOTAL ASSETS
$
2,055,567 $
2,136,223
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses
$
185,332 $
240,561
Accrued sales discounts, allowances and reserves
272,452
263,641
Operating lease liabilities—short-term
6,166
5,746
Contract liabilities—short-term
1,249
2,730
Current portion of long-term debt
—
3,000
Liabilities related to discontinued operations
—
4,542
Total current liabilities
465,199
520,220
LONG-TERM DEBT
—
287,730
OPERATING LEASE LIABILITIES—LONG-TERM
69,372
75,709
OTHER LONG-TERM LIABILITIES
56,019
49,878
Total liabilities
590,590
933,537
COMMITMENTS AND CONTINGENT LIABILITIES (Note 19)
SHAREHOLDERS’ EQUITY:
Preferred shares, par value, $0.01 per share; 50,000,000 shares authorized; and zero issued and
outstanding at December 31, 2024 and 2023
—
—
Ordinary shares, par value, $0.01 per share; 450,000,000 shares authorized; 176,670,785 and
172,569,051 shares issued; and 162,176,994 and 166,979,833 shares outstanding at December 31,
2024 and 2023, respectively
1,767
1,726
Treasury shares, at cost (14,493,791 and 5,589,218 shares at December 31, 2024 and 2023,
respectively)
(419,255 )
(189,336 )
Additional paid-in capital
2,860,890
2,736,934
Accumulated other comprehensive loss
(1,967 )
(3,110 )
Accumulated deficit
(976,458 )
(1,343,528 )
Total shareholders’ equity
1,464,977
1,202,686
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$
2,055,567 $
2,136,223
The accompanying notes are an integral part of these consolidated financial statements.
F-4
ALKERMES PLC AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
Years Ended December 31, 2024, 2023 and 2022
Year Ended December 31,
2024
2023
2022
(In thousands, except per share amounts)
REVENUES:
Product sales, net
$
1,083,534 $
919,998 $
777,552
Manufacturing and royalty revenues
474,095
743,388
331,983
License revenue
—
—
2,000
Research and development revenue
3
19
260
Total revenues
1,557,632
1,663,405
1,111,795
EXPENSES:
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible
assets shown below)
245,331
253,037
218,068
Research and development
245,326
270,806
272,702
Selling, general and administrative
645,238
689,751
590,751
Amortization of acquired intangible assets
1,101
35,689
36,363
Total expenses
1,136,996
1,249,283
1,117,884
OPERATING INCOME FROM CONTINUING OPERATIONS
420,636
414,122
(6,089 )
OTHER INCOME (EXPENSE), NET:
Interest income
42,450
30,854
7,629
Interest expense
(22,578 )
(23,032 )
(13,040 )
Change in the fair value of contingent consideration
—
—
(21,750 )
Other income (expense), net
3,242
(425 )
2,122
Total other income (expense), net
23,114
7,397
(25,039 )
INCOME (LOSS) BEFORE INCOME TAXES
443,750
421,519
(31,128 )
INCOME TAX PROVISION (BENEFIT)
71,612
(97,638 )
2,024
NET INCOME (LOSS) FROM CONTINUING OPERATIONS
372,138
519,157
(33,152 )
LOSS FROM DISCONTINUED OPERATIONS, NET OF TAX
(5,068 )
(163,400 )
(125,115 )
NET INCOME (LOSS)
$
367,070 $
355,757 $
(158,267 )
EARNINGS (LOSS) PER ORDINARY SHARE:
Earnings (loss) per ordinary share from continuing operations - basic
$
2.25 $
3.12 $
(0.20 )
Loss per ordinary share from discontinued operations - basic
$
(0.03 ) $
(0.98 ) $
(0.76 )
Earnings (loss) per ordinary share - basic
$
2.22 $
2.14 $
(0.97 )
Earnings (loss) per ordinary share from continuing operations - diluted
$
2.20 $
3.06 $
(0.20 )
Loss per ordinary share from discontinued operations - diluted
$
(0.03 ) $
(0.96 ) $
(0.76 )
Earnings (loss) per ordinary share - diluted
$
2.17 $
2.10 $
(0.97 )
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING:
Basic
165,392
166,223
163,742
Diluted
169,198
169,730
163,742
COMPREHENSIVE INCOME (LOSS):
Net income (loss)
$
367,070 $
355,757 $
(158,267 )
Holding gain (loss), net of a tax provision (benefit) of $292, $1,195 and $(973), respectively
1,143
7,779
(7,166 )
COMPREHENSIVE INCOME (LOSS)
$
368,213 $
363,536 $
(165,433 )
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, 2024, 2023 and 2022
Accumulate
d
Additional
Other
Ordinary Shares
Paid-In
Comprehen
sive
Accumulat
ed
Treasury Stock
Shares
Amount
Capital
Loss
Deficit
Shares
Amount
Total
(In thousands, except share data)
BALANCE — December 31, 2021
165,790,54
9 $
1,658 $ 2,798,325 $
(3,723 ) $
(1,541,01
8 ) (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' ordinary 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
168,951,19
3 $
1,690 $ 2,913,099 $
(10,889 ) $
(1,699,28
5 ) (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' ordinary 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
172,569,05
1 $
1,726 $ 2,736,934 $
(3,110 ) $
(1,343,52
8 ) (5,589,218 ) $
(189,336 ) $
1,202,686
Issuance of ordinary shares under employee stock
plans
4,101,734
41
27,531
—
—
—
—
27,572
Receipt of Alkermes' ordinary shares for the purchase
of stock options or to satisfy minimum tax
withholding obligations related to share-based awards
—
—
—
—
— (1,010,156 )
(29,637 )
(29,637 )
Repurchase of Alkermes' ordinary shares
—
—
—
—
— (7,894,417 )
(200,282 )
(200,282 )
Share-based compensation
—
—
96,425
—
—
—
—
96,425
Unrealized gain on marketable securities, net of tax
provision of $292
—
—
—
1,143
—
—
—
1,143
Net income
—
—
—
—
367,070
—
—
367,070
BALANCE —December 31, 2024
176,670,78
5 $
1,767 $ 2,860,890 $
(1,967 ) $ (976,458 )
(14,493,79
1 ) $
(419,255 ) $
1,464,977
The accompanying notes are an integral part of these consolidated financial statements.
F-6
ALKERMES PLC AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
Years Ended December 31, 2024, 2023 and 2022
Year Ended December 31,
2024
2023
2022
(In thousands)
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)
$
367,070 $
355,757 $
(158,267 )
Adjustments to reconcile net income (loss) to cash flows from operating activities:
Depreciation and amortization
28,533
74,927
77,862
Share-based compensation expense
96,637
100,905
94,254
Deferred income taxes
40,522
(99,902 )
(32,795 )
Change in the fair value of contingent consideration
—
—
21,750
Other non-cash charges
4,512
6,329
5,531
Changes in assets and liabilities:
Receivables
(52,052 )
(44,510 )
25,250
Contract assets
(4,284 )
8,223
4,434
Inventory
3,091
(2,712 )
(31,021 )
Prepaid expenses and other assets
2,254
(34,847 )
(5,328 )
Right-of-use assets
7,215
15,387
16,569
Accounts payable and accrued expenses
(57,967 )
23,009
15,534
Accrued sales discounts, allowances and reserves
8,811
11,526
14,899
Contract liabilities
(3,525 )
(5,926 )
(7,129 )
Operating lease liabilities
(10,123 )
(16,147 )
(33,225 )
Other long-term liabilities
8,430
9,334
12,726
Cash flows provided by operating activities
439,124
401,353
21,044
CASH FLOWS FROM INVESTING ACTIVITIES:
Additions of property, plant and equipment
(33,484 )
(48,048 )
(38,255 )
Proceeds from the sale of equipment
461
354
—
Proceeds from contingent consideration
—
—
1,273
Return of Fountain Healthcare Partners II, L.P. investment
43
—
485
Proceeds from the sale of the Athlone Facility
97,933
—
—
Purchases of investments
(486,547 )
(254,471 )
(309,671 )
Sales and maturities of investments
310,286
355,522
281,627
Cash flows (used in) provided by investing activities
(111,308 )
53,357
(64,541 )
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
27,572
16,760
19,630
Employee taxes paid related to net share settlement of equity awards
(29,637 )
(28,474 )
(18,204 )
Payment for the repurchase of ordinary shares
(200,282 )
—
—
Prepayment of long-term debt
(289,542 )
—
—
Principal payments of long-term debt
(2,250 )
(3,000 )
(3,000 )
Cash flows used in financing activities
(494,139 )
(289,714 )
(1,574 )
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
(166,323 )
164,996
(45,071 )
CASH AND CASH EQUIVALENTS—Beginning of period
457,469
292,473
337,544
CASH AND CASH EQUIVALENTS—End of period
$
291,146 $
457,469 $
292,473
SUPPLEMENTAL CASH FLOW DISCLOSURE:
Cash paid for interest
$
23,010 $
22,748 $
13,563
Cash paid for taxes
$
2,592 $
44,243 $
20,749
Non-cash investing and financing activities:
Purchased capital expenditures included in accounts payable and accrued expenses
$
2,254 $
2,645 $
2,950
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 is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. Alkermes has a portfolio
of proprietary commercial products for the treatment of alcohol dependence and opioid dependence, schizophrenia and bipolar I disorder and a pipeline of
clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland,
Alkermes also has a corporate office and research and development (“R&D”) center in Massachusetts and a manufacturing facility in Ohio.
In May 2024, the Company completed the sale of its development and manufacturing facility in Athlone, Ireland (the “Athlone Facility”) and related
business to Novo Nordisk (“Novo”) pursuant to an asset purchase agreement entered into in December 2023. The Company and Novo also entered into
subcontracting arrangements to continue certain development and manufacturing activities performed at the Athlone Facility for a period of time after the
closing of the transaction, which activities may continue through the end of 2025. In connection with the sale of the Athlone Facility, the Company
received $97.9 million from Novo, which included a payment of approximately $91.0 million for the facility and certain related assets, and recorded a gain
of approximately $1.5 million within “Other income (expense), net” in the accompanying consolidated statements of operations and comprehensive income
(loss) for the year ended December 31, 2024. As of December 31, 2023, the Company classified the assets described under the asset purchase agreement
for the sale as “Assets held for sale” in the accompanying consolidated balance sheet.
In November 2023, the Company completed the separation of its former oncology business into Mural Oncology plc (“Mural”), a new, independent,
publicly-traded company (the “Separation”). The Separation was effected by means of a distribution of all of the outstanding ordinary shares of Mural to
the Company’s shareholders (the “Distribution”), in which each of the Company’s shareholders received one ordinary share, nominal value $0.01 per share,
of Mural for every ten ordinary shares, par value $0.01 per share, of the Company (the “Distribution Ratio”) held by such shareholder as of the close of
business on November 6, 2023, the record date for the Distribution (the “Record Date”). 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.
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 as of December 31,
2023 and for the years ended December 31, 2023 and 2022. See Note 3, Discontinued Operations in these “Notes to Consolidated Financial Statements” in
this Annual Report for additional information.
Discontinued Operations
The Company determined that the Separation met the criteria for classification of the former oncology business as discontinued operations in
accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 205, Discontinued Operations.
Accordingly, the accompanying consolidated financial statements have been updated to present the results of the oncology business as discontinued
operations through the Separation Date for the years ended December 31, 2023 and 2022 in the consolidated statements of operations and comprehensive
income (loss).
Assets Held for Sale
In connection with the sale of the Athlone Facility, the Company reviewed FASB ASC 805, Business Combinations (“Topic 805”) and, based on the
definitions therein, determined that the Athlone Facility constituted a business. Accordingly, the assets associated with the sale of the Athlone Facility were
classified as “Assets held for sale” in the accompanying consolidated balance sheet as of December 31, 2023.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-8
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
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 its market value. The
Company considers as cash equivalents only those investments that are highly liquid, readily convertible into cash and so near their maturity (three months
from the date of purchase) that they present insignificant risk of change in value because of interest rate changes.
Investments
The Company has investments in various types of securities, consisting primarily of United States (“U.S.”). government and agency obligations and
corporate debt securities. The Company generally holds its interest-bearing investments with major financial institutions and in accordance with
documented investment policies. The Company limits the amount of credit exposure to any one financial institution or corporate issuer. At December 31,
2024, 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, 2024, 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, 2024 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,
2024 included U.S. government agency debt securities and investments in corporate debt securities that are trading in the credit markets.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-9
The carrying amounts reflected in the consolidated balance sheets for cash and cash equivalents, accounts receivable, contract assets, other current
assets, accounts payable and accrued expenses and accrued sales discounts, allowances and reserves approximate fair value due to their short-term nature.
Inventory
Inventory is stated at the lower of cost and net realizable value. The Company utilizes a standard cost basis, which approximates cost determined
using the first-in first-out method. Cost is determined using the first-in, first-out method. 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 facility and does not include costs from abnormally low production or idle capacity, which are expensed directly to
the consolidated statement of operations and comprehensive income (loss).
The Company capitalizes inventory costs associated with its products prior to regulatory approval when, based on management’s judgment, future
commercialization of the product is considered probable and future economic benefit from such product is expected to be realized. 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
25 years
Furniture, fixtures and equipment
5 - 7 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.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-10
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 when its customer obtains control of promised goods or services, in an amount that reflects the consideration
which it expects to receive in exchange for those goods or services. The Company recognizes revenue following the five-step model prescribed in
accordance with FASB ASC 606, Revenue from Contracts with Customers (“Topic 606”): (i) identify contract(s) with a customer; (ii) identify the
performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the
contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations.
Product Sales, Net
The Company’s product sales, net consist of sales in the U.S. of VIVITROL®, ARISTADA®, ARISTADA INITIO® and LYBALVI®, primarily to
wholesalers, specialty distributors and pharmacies. Product sales, net are recognized when the customer obtains control of the product, which is when the
product has been received by the customer.
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. In 2024,
actual Medicaid utilization rates related to VIVITROL were lower than original estimates, due, in part, to $8.7 million in actual credits
received from certain states in the fourth quarter of 2024 related to duplicate Medicaid billings. Medicaid rebates for the Company’s other
products have not differed materially from the Company’s estimates;
•
Chargebacks—discounts that occur when contracted indirect customers purchase directly from wholesalers and specialty distributors.
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;
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-11
•
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.
A rollforward of the Company’s provisions for sales and allowances is as follows:
December 31, 2024
(In thousands)
Contractual
Adjustments
Discounts
Product Returns
Other
Total
Beginning balance — December 31, 2023
$
234,414 $
28,690 $
41,064 $
10,164 $
314,332
Current provisions relating to sales in current year
557,651
386,625
28,627
87,373
1,060,276
Adjustments relating to prior years
(20,562 )
—
(3,700 )
—
(24,262 )
Payments/credits relating to sales in current year
(369,869 )
(353,629 )
—
(70,752 )
(794,250 )
Payments/credits relating to sales in prior years
(172,656 )
(18,041 )
(15,484 )
(13,488 )
(219,669 )
Ending balance — December 31, 2024
$
228,978 $
43,645 $
50,507 $
13,297 $
336,427
December 31, 2023
(In thousands)
Contractual
Adjustments
Discounts
Product Returns
Other
Total
Beginning balance — December 31, 2022
$
226,741 $
26,175 $
29,666 $
7,938 $
290,520
Current provisions relating to sales in current year
509,780
326,860
33,417
71,449
941,506
Adjustments relating to prior years
(8,921 )
—
2,841
—
(6,080 )
Payments/credits relating to sales in current year
(308,353 )
(293,785 )
—
(56,224 )
(658,362 )
Payments/credits relating to sales in prior years
(184,833 )
(30,560 )
(24,860 )
(12,999 )
(253,252 )
Ending balance — December 31, 2023
$
234,414 $
28,690 $
41,064 $
10,164 $
314,332
December 31, 2022
(In thousands)
Contractual
Adjustments
Discounts
Product Returns
Other
Total
Beginning balance — December 31, 2021
$
209,760 $
24,150 $
24,313 $
9,585 $
267,808
Current provisions relating to sales in current year
434,143
281,308
15,851
58,788
790,090
Adjustments relating to prior years
(22,019 )
—
3,294
—
(18,725 )
Payments/credits relating to sales in current year
(237,521 )
(252,896 )
—
(48,834 )
(539,251 )
Payments/credits relating to sales in prior years
(157,622 )
(26,387 )
(13,792 )
(11,601 )
(209,402 )
Ending balance — December 31, 2022
$
226,741 $
26,175 $
29,666 $
7,938 $
290,520
(1)
“Contractual Adjustments” include “Medicaid Rebates” and “Medicare Part D” accruals
(2)
“Discounts” include “Chargebacks” and “Product Discounts”
Total revenue-related reserves as of December 31, 2024 and 2023, included in our consolidated balance sheets, are summarized as follows:
(1)
(2)
(1)
(2)
(1)
(2)
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-12
Year Ended December 31,
(In thousands)
2024
2023
Reduction of accounts receivable
$
22,031 $
11,510
Components of accrued sales discounts, allowances and reserves
272,452
263,641
Components of other long-term liabilities
41,944
39,181
Total revenue-related reserves
$
336,427 $
314,332
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® (collectively, the “long-acting INVEGA products”) and RISPERDAL CONSTA®, and
Biogen International 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 received or 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.
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 $69.5 million and $103.1 million at December 31, 2024 and 2023,
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 $0.3 million and $0.2
million at December 31, 2024 and 2023, respectively.
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.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-13
Contract assets consisted of the following:
(In thousands)
Contract Assets
Contract assets at January 1, 2023
$
8,929
Additions
13,606
Transferred to receivables, net
(21,829 )
Contract assets at December 31, 2023
$
706
Additions
6,615
Transferred to receivables, net
(2,331 )
Contract assets at December 31, 2024
$
4,990
Contract Liabilities
Contract liabilities consist of contractual obligations related to deferred revenue. At December 31, 2024 and 2023, $1.2 million and $2.7 million of
the contract liabilities, respectively, were classified as “Contract liabilities–short-term” in the accompanying consolidated balance sheets and none and $2.1
million of the contract liabilities, respectively, were classified as “Other long-term liabilities” in the accompanying consolidated balance sheets.
Contract liabilities consisted of the following:
(In thousands)
Contract Liabilities
Contract liabilities at January 1, 2023
$
10,701
Additions
(931 )
Amounts recognized into revenue
(4,995 )
Contract liabilities at December 31, 2023
$
4,775
Additions
34
Amounts recognized into revenue
(3,560 )
Contract liabilities at December 31, 2024
$
1,249
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 income (expense), net” in the accompanying
consolidated statements of operations and comprehensive income (loss). During the years ended December 31, 2024, 2023 and 2022, the Company
recorded losses of $0.8 million and $0.5 million and a gain of $0.7 million, respectively, on foreign currency translation.
Concentrations
Financial instruments that potentially subject the Company to concentrations of credit risk are receivables and marketable securities. Billings to
large pharmaceutical companies and pharmaceutical wholesalers account for the majority of the Company’s receivables, and collateral is not required from
these customers. To mitigate credit risk, the Company monitors the financial performance and credit-worthiness of its customers. 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, 2024,
2023 and 2022:
Year Ended December 31,
2024
2023
2022
Customer
Receivables
Revenue
Receivables
Revenue
Receivables
Revenue
McKesson
36 %
25 %
14 %
14 %
12 %
16 %
Cencora
17 %
15 %
16 %
12 %
18 %
14 %
Cardinal Health
16 %
19 %
24 %
20 %
24 %
24 %
Janssen
14 %
17 %
23 %
31 %
*
15 %
Biogen
*
11 %
*
11 %
19 %
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, 2024, 2023 and 2022, as noted.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-14
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 generate investment income.
Geographic Information
Company revenues by geographic location for the years ended December 31, 2024, 2023 and 2022, as determined by the location of the customer,
are as follows:
Year Ended December 31,
(In thousands)
2024
2023
2022
Revenue by region:
U.S.
$
1,410,159 $
1,491,939 $
931,991
Ireland
1,294
1,179
1,829
Rest of world
146,179
170,287
177,975
The location of the Company’s assets are as follows:
December 31,
(In thousands)
2024
2023
Assets by region:
Current assets:
U.S.:
Cash and cash equivalents
$
70,303 $
317,850
Investments—short-term
203,631
187,574
Receivables, net
306,259
218,747
Other current assets
129,332
143,417
Ireland:
Cash and cash equivalents
$
220,843 $
139,619
Investments—short-term
256,891
128,448
Receivables, net
78,269
113,730
Assets held for sale
—
94,260
Other current assets
149,827
141,861
Long-term assets:
U.S.:
Property, plant and equipment, net
$
226,646 $
225,578
Investments—long-term
24,629
17,957
Other
210,792
189,335
Ireland:
Property, plant and equipment, net
$
918 $
1,365
Investments—long-term
48,519
21,930
Intangible assets, net and goodwill
83,917
85,018
Other
44,791
109,534
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.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-15
Advertising costs are expensed as incurred. During the years ended December 31, 2024, 2023 and 2022, advertising costs totaled $107.6 million,
$127.6 million and $41.4 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 or in a service relationship with the Company during the applicable vesting period. Except as otherwise provided in the applicable Plan or Award
Certificate (as defined in the 2018 Plan): (i) annual stock option grants to non-employee directors expire ten years from the date of grant and generally vest
over a one-year period; and (ii) stock option grants to new non-employee directors expire ten years from the date of grant and generally vest over a three-
year period. The estimated fair value of options is recognized over the requisite service period, which is generally the vesting period. 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,
2024
2023
2022
Expected option term
5 - 7 years
5 - 8 years
5 - 8 years
Expected stock volatility
38 % - 42 %
40 % - 44 %
43 % - 51 %
Risk-free interest rate
3.64 % - 4.60 %
3.34 % - 4.75 %
1.83 % - 4.26 %
Expected annual dividend yield
—
—
—
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 or in a service relationship
with the Company during the applicable vesting period. Shares subject to these RSUs are delivered to the employee upon vesting, subject to payment of
applicable withholding taxes. 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.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-16
Performance-Based Restricted Stock Unit Awards
Performance-based RSUs awarded to employees vest upon the achievement of certain performance criteria, typically during or following the end of
a specified performance period. The estimated fair value of these performance-based RSUs are generally based on the closing price of the Company’s
ordinary shares traded on the Nasdaq Global Select Market on the date of grant, unless the performance-based RSU is also subject to a market condition. In
that case, the fair value of the performance-based RSU is based on a Monte Carlo simulation model. Compensation expense for performance-based RSUs
is recognized from the date the Company determines the performance criteria probable of being achieved to the date the award, or relevant portion of the
award, is expected to vest. Cumulative adjustments are recorded on a quarterly basis to reflect subsequent changes to the estimated outcome of the
performance criteria until the date that the final outcome of the performance criteria is determined.
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.
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
In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting: Improvements to Reportable Segment
Disclosure (“Topic 280”) to establish standards for reporting information about operating segments. Operating segments are defined as components of an
enterprise engaging in business activities for which separate financial information is available and regularly reviewed by the chief operating decision maker
(“CODM”) in deciding how to allocate resources and in assessing performance. The Company has utilized the management approach to determine that the
Company is managed as one segment on a consolidated basis and is the business of developing, manufacturing and commercializing medicines designed to
address unmet medical needs of patients in major therapeutic areas. The Company’s CODM, the Chairman and Chief Executive Officer, reviews the
Company’s operating results on an aggregate basis and manages the Company’s operations as a single operating unit. The CODM measures profitability on
a reportable segment basis using net income (loss) and utilizes this information in allocating resources and in assessing performance by monitoring budget
versus actual results. Please refer to Note 18, Segment Reporting, in these “Notes to Consolidated Financial Statements” in this Annual Report for further
information.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-17
Employee Benefit Plans
401(k) Plan
The Company maintains a 401(k) retirement savings plan (the “401(k) Plan”), which covers all of its eligible U.S.-based employees. Eligible
employees may contribute up to 100% of their eligible compensation, subject to certain Internal Revenue Service (“IRS”) limitations. 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, 2024, 2023 and 2022, the Company contributed $15.1 million, $15.0 million and $14.4 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, 2024, 2023 and 2022, the Company contributed $3.4 million, $5.6 million and $5.1 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 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.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income-Expense Disaggregation Disclosures, to
improve disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of
expenses (including purchases of inventory, employee compensation, depreciation, amortization and depletion) in commonly-presented expense captions,
such as cost of sales, selling, general and administrative expenses, and research and development. All disclosure requirements under this guidance are
required for public business entities and effective for annual periods beginning after December 15, 2026 and interim periods beginning after December 15,
2027. Early adoption is permitted and the amendments in this guidance will be applied prospectively to financial statements for periods after the effective
dates. 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
In November 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, set forth the Company’s agreements with Mural regarding the principal actions taken
or to be taken in connection with the Separation, including the Distribution. The separation agreement identified those assets to be transferred to, liabilities
to be assumed by and contracts to be assigned to Mural, including the operating lease for the office and laboratory space at 852 Winter Street in Waltham,
Massachusetts, as part of the Separation, and it provided for when and how such transfers, assumptions and assignments were to occur. The purpose of the
separation agreement was to provide Mural and the Company with those assets necessary to operate their respective businesses and to retain or assume the
respective liabilities related to those assets.
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.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-18
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 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.
Discontinued Operations
The results of the former oncology business and transaction costs related to the Separation have been reflected as “Loss from discontinued
operations, net of taxes” in the accompanying consolidated statement of operations and comprehensive income (loss) through the Separation Date. Prior
periods have been recast to reflect this presentation. The transaction costs related to the Separation were $36.0 million during 2023 and $1.4 million during
2022, and primarily relate to professional fees for separation activities within the finance, tax, legal and information technology functions.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-19
The following table summarizes expenses of the discontinued operations for the years ended December 31, 2024, 2023 and 2022:
Year Ended December 31,
(In thousands)
2024
2023
2022
Operating expenses from discontinued operations
Cost of goods manufactured
$
— $
39 $
40
Research and development
5,790
116,177
121,140
Selling, general and administrative
—
48,587
14,996
Total operating expenses from discontinued operations
5,790
164,803
136,176
Operating loss from discontinued operations
(5,790 )
(164,803 )
(136,176 )
Income tax benefit from discontinued operations
(722 )
(1,403 )
(11,061 )
Net loss and comprehensive loss from discontinued operations
$
(5,068 ) $
(163,400 ) $
(125,115 )
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
as of December 31, 2023 related to bonus amounts accrued for employees that transferred to Mural during 2023 through the Separation Date that were paid
by the Company in the first quarter of 2024, in accordance with the terms of the employee matters agreement entered into between the Company and
Mural.
The following table summarizes the significant non-cash items and capital expenditures of the discontinued operations that are included in the
consolidated statements of cash flows for the years ended December 31, 2023 and 2022:
Year Ended December 31,
(In thousands)
2023
2022
OPERATING ACTIVITIES:
Depreciation
$
2,319 $
1,539
Share-based compensation expense
8,188
6,577
Right-of-use assets
3,803
5,909
Operating lease liabilities
(3,938 )
(5,920 )
INVESTING ACTIVITIES:
Additions of property, plant and equipment
$
(1,798 ) $
(5,510 )
4. REVENUE FROM CONTRACTS WITH CUSTOMERS
During the years ended December 31, 2024, 2023 and 2022, the Company recorded product sales, net, as follows:
Year Ended December 31,
(In thousands)
2024
2023
2022
VIVITROL
$
457,315 $
400,419 $
379,478
ARISTADA and ARISTADA INITIO
346,187
327,690
302,052
LYBALVI
280,032
191,889
96,022
Total product sales, net
$
1,083,534 $
919,998 $
777,552
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-20
During the years ended December 31, 2024, 2023 and 2022, the Company recorded manufacturing and royalty revenues from its collaboration
arrangements as follows:
Year Ended December 31, 2024
(In thousands)
Manufacturing
Revenue
Royalty
Revenue
Total
Long-acting INVEGA products
$
—
$
236,386
$
236,386
VUMERITY
39,292
94,755
134,047
RISPERDAL CONSTA
23,172
272
23,444
Other
56,962
23,256
80,218
$
119,426
$
354,669
$
474,095
Year Ended December 31, 2023
(In thousands)
Manufacturing
Revenue
Royalty
Revenue
Total
Long-acting INVEGA products
$
—
$
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
$
—
$
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
(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 recorded $486.1 million 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
(1)
(1)
(1)
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-21
represented a portion of the royalty revenue paid to the Company by Acorda since July 2020 related to AMPYRA. The Company paid Acorda the
aggregate $18.3 million in the fourth quarter of 2022. In addition, during the three months ended June 30, 2022, the Company had recorded $3.2 million of
royalty revenue related to AMPYRA as the Company believed that it had met the necessary revenue recognition criteria under Topic 606. 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, 2024
Cost
Gains
One Year
One Year
Fair Value
Short-term investments:
Available-for-sale securities:
U.S. government and agency debt securities
$
266,506 $
763 $
(58 ) $
(6 ) $
267,205
Corporate debt securities
192,617
762
(58 )
(4 )
193,317
Total short-term investments
459,123
1,525
(116 )
(10 )
460,522
Long-term investments:
Available-for-sale securities:
U.S. government and agency debt securities
48,856
—
—
(179 )
48,677
Corporate debt securities
24,484
—
—
(158 )
24,326
73,340
—
—
(337 )
73,003
Held-to-maturity securities:
Certificates of deposit
145
—
—
—
145
Total long-term investments
73,485
—
—
(337 )
73,148
Total investments
$
532,608 $
1,525 $
(116 ) $
(347 ) $
533,670
December 31, 2023
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
At December 31, 2024, 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, 2024, 77 of the Company’s 320 investment securities were in an unrealized loss position and had an aggregate
estimated fair value of $112.7 million. Approximately 41% and 59% of the Company’s investment securities at December 31, 2024 were in corporate debt
securities, with a minimum rating of A2
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-22
(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)
2024
2023
2022
Proceeds from the sales and maturities of investments
$
310,286 $
355,522 $
281,627
Realized gains
$
— $
— $
—
Realized losses
$
— $
— $
529
The Company’s available-for-sale and held-to-maturity securities at December 31, 2024 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
$
324,897 $
325,566 $
145 $
145
After 1 year through 5 years
207,566
207,959
—
—
Total
$
532,463 $
533,525 $
145 $
145
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)
2024
Level 1
Level 2
Level 3
Assets:
Cash equivalents
$
8,388 $
8,388 $
— $
—
U.S. government and agency debt securities
315,882
265,090
50,792
—
Corporate debt securities
217,643
—
217,643
—
Total
$
541,913 $
273,478 $
268,435 $
—
December 31,
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 $
—
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, 2024. At December 31, 2024, the Company had no
investments with fair values that were determined using Level 3 inputs.
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.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-23
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 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 the accompanying
consolidated statements of operations and comprehensive income (loss) for the year ended December 31, 2022. In addition, during the three months ended
September 30, 2022, the Company determined that certain construction in progress related to the manufacture of ANJESO® had no future value and
recorded a $2.3 million write off within “Other income (expense), net” in the accompanying consolidated statements of operations and comprehensive
income (loss) for the year ended December 31, 2022.
In December 2022, Baudax announced that it would discontinue the sale of ANJESO and the U.S. Food and Drug Administration (“FDA”)
acknowledged the discontinuation of sale of ANJESO via listing in the Orange Book.
7. INVENTORY
Inventory consists of the following:
December 31,
December 31,
(In thousands)
2024
2023
Raw materials
$
72,139 $
71,416
Work in process
79,871
68,843
Finished goods
30,877
46,147
Total inventory
$
182,887 $
186,406
(1)
At December 31, 2024 and 2023, the Company had $22.7 million and $33.9 million, respectively, of finished goods inventory located at its third-party warehouse and shipping
service provider.
8. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consists of the following:
December 31,
December 31,
(In thousands)
2024
2023
Land
$
957 $
957
Building and improvements
134,699
132,735
Furniture, fixtures and equipment
244,113
237,728
Leasehold improvements
42,416
39,893
Construction in progress
58,391
45,791
Subtotal
480,576
457,104
Less: accumulated depreciation
(253,012 )
(230,161 )
Total property, plant and equipment, net
$
227,564 $
226,943
(1)
In connection with the sale of the Athlone Facility, $92.2 million of the Company’s property, plant and equipment was classified as “Assets held for sale” in the accompanying
consolidated balance sheet at December 31, 2023 and was not included in these amounts.
(1)
(1)
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-24
Depreciation expense was $27.4 million, $25.7 million and $26.3 million for the years ended December 31, 2024, 2023 and 2022, respectively.
Also, during the years ended December 31, 2024, 2023 and 2022, the Company wrote off furniture, fixtures and equipment that had an approximate
carrying value of $0.5 million, $1.7 million and $0.5 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 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 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. INTANGIBLE ASSETS AND GOODWILL
Intangible assets and goodwill consists of the following:
December 31, 2024
December 31, 2023
(In thousands)
Weighted
Amortizable
Life (Years)
Gross Carrying
Amount
Accumulated
Amortization
Net Carrying
Amount
Gross Carrying
Amount
Accumulated
Amortization
Net Carrying
Amount
Goodwill
$
83,027 $
— $
83,027 $
83,027 $
— $
83,027
Finite-lived intangible assets:
Collaboration agreements
12
$
465,590 $
(465,590 ) $
— $
465,590 $
(465,590 ) $
—
Capitalized IP
11-13
118,160
(117,270 )
890
118,160
(116,169 )
1,991
Total
$
583,750 $
(582,860 ) $
890 $
583,750 $
(581,759 ) $
1,991
In connection with the sale of the Athlone Facility, the Company reviewed Topic 805 and determined that the Athlone Facility constituted a business
and, accordingly, $2.0 million of the Company’s goodwill was allocated to the Athlone Facility and was classified as “Assets held for sale” in the
accompanying consolidated balance sheet as of December 31, 2023.
The Company’s finite-lived intangible assets primarily consisted of collaborative agreements and the NanoCrystal and oral controlled release
technologies acquired as part of the EDT acquisition. These intangible assets were fully amortized in the year ended December 31, 2024. The Company
recorded $1.1 million, $35.7 million and $36.4 million of amortization expense related to its finite-lived intangible assets during the years ended December
31, 2024, 2023 and 2022, respectively.
The Company performed its annual goodwill impairment test as of October 31, 2024. The Company elected to perform a qualitative impairment test
and determined that based on the weight of all available evidence, the fair value of the reporting unit more-likely-than-not exceeded its carrying value.
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, Inc., a wholly-owned subsidiary of the Company (“Alkermes US”) and Mural
Oncology, Inc., a wholly-owned subsidiary of Mural (“Mural US”) entered into an assignment and assumption of lease agreement (the “Assignment”),
pursuant to which Alkermes US assigned to Mural US an operating lease for approximately 180,000 square feet of corporate office space, administrative
areas and laboratories located at 852 Winter Street in Waltham, Massachusetts (the “852 Winter Street Lease”). Under the terms of the Assignment, Mural
US assumed all of Alkermes US’ obligations under the 852 Winter Street Lease. 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.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-25
At December 31, 2024 and 2023, the operating leases held by the Company had a weighted average incremental borrowing rate of 4.0% and 4.4%,
respectively, and a weighted average remaining lease term of 7.2 years and 8.7 years, respectively. During the years ended December 31, 2024, 2023 and
2022, cash paid for amounts included for the measurement of lease liabilities was $10.1 million, $10.3 million and $27.0 million, respectively. The
Company recorded operating lease expense of $7.2 million, $10.2 million and $10.7 million for the years ended December 31, 2024, 2023 and 2022,
respectively.
Future lease payments under non-cancelable leases as of December 31, 2024 consisted of the following:
December 31,
(In thousands)
2024
2025
10,189
2026
10,259
2027
9,505
2028
9,574
Thereafter
59,695
Total operating lease payments
$
99,222
Less: imputed interest
(23,684 )
Total operating lease liabilities
$
75,538
11. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consists of the following:
December 31,
December 31,
(In thousands)
2024
2023
Accounts payable
$
45,630 $
65,649
Accrued compensation
70,960
83,107
Accrued other
68,742
91,805
Total accounts payable and accrued expenses
$
185,332 $
240,561
A summary of the Company’s current provision for sales discounts, allowances and reserves is as follows:
December 31,
December 31,
(In thousands)
2024
2023
Medicaid rebates
$
202,044 $
213,845
Product discounts
19,351
15,121
Medicare Part D
26,933
20,569
Other
24,124
14,106
Total accrued sales discounts, allowances and reserves
$
272,452 $
263,641
Included in accounts payable was approximately $11.4 million and $34.5 million of amounts payable related to state Medicaid rebates as of
December 31, 2024 and 2023, respectively.
12. LONG-TERM DEBT
In December 2024, the Company prepaid in full all previously outstanding term loans (the “Former Term Loans”) under the Former Credit
Agreement without penalty, through paying off the remaining principal amount due of $289.5 million. The Company accounted for such prepayment as a
debt extinguishment and recorded a loss of approximately $0.8 million within “Other income (expense), net” in the accompanying consolidated statements
of operations and comprehensive income (loss) for the year ended December 31, 2024.
The Former Term Loans bore interest at the Secured Overnight Financing Rate (“SOFR”) plus a credit spread adjustment applicable to the interest
period and an applicable margin of 2.50% with a floor of 0.5%. As of December 31, 2024 and 2023, long-term debt consisted of the following:
December 31,
December 31,
(In thousands)
2024
2023
Former Term Loans (due March 12, 2026)
$
— $
290,730
Less: current portion
—
(3,000 )
Long-term debt
$
— $
287,730
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-26
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)
2024
2023
2022
Numerator:
Net income (loss) from continuing operations
$
372,138
$
519,157
$
(33,152 )
Net loss from discontinued operations
(5,068 )
(163,400 )
(125,115 )
Net income (loss)
$
367,070
$
355,757
$
(158,267 )
Denominator:
Weighted average number of ordinary shares outstanding
165,392
166,223
163,742
Effect of dilutive securities:
Stock options
1,377
1,093
—
Restricted stock unit awards
2,429
2,414
—
Dilutive ordinary share equivalents
3,806
3,507
—
Shares used in calculating diluted earnings (loss) per ordinary share
169,198
169,730
163,742
(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 income (loss) per share calculation because the effect would have
been anti-dilutive:
Year Ended December 31,
(In thousands)
2024
2023
2022
Stock options
11,517
12,422
12,777
Restricted stock unit awards
2,391
2,378
5,040
Total
13,908
14,800
17,817
(1)
Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation.
14. SHAREHOLDERS’ EQUITY
Share Repurchase Program
In February 2024, the Company’s board of directors approved a share repurchase program authorizing the Company to repurchase ordinary shares
of the Company in an aggregate amount of up to $400.0 million (exclusive of any fees, commissions or other expenses related to such repurchases) from
time to time on the open market (the “Repurchase Program”). The specific timing and amounts of repurchases under the Repurchase Program will depend
on a variety of factors, including but not limited to ongoing assessments of the Company’s needs, alternative investment opportunities, the market price of
the Company’s ordinary shares and general market conditions. The Repurchase Program has no set expiration date and may be suspended or discontinued
at any time. During the year ended December 31, 2024, the Company repurchased approximately 7.9 million of its ordinary shares under the Repurchase
Program at an average price of $25.33 per share, resulting in a total cost, exclusive of any fees, commissions or other expenses related to such repurchase of
$200.0 million. All ordinary shares repurchased were returned to treasury. As of December 31, 2024, the remaining amount authorized under the
Repurchase Program was $200.0 million.
(1)
(1)
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-27
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)
2024
2023
2022
Cost of goods manufactured and sold
$
5,798 $
11,353 $
10,284
Research and development
28,085
25,753
23,289
Selling, general and administrative
62,754
55,611
54,104
Share-based compensation expense from continuing operations
96,637
92,717
87,677
Cost of goods manufactured and sold
—
—
—
Research and development
—
3,255
4,652
Selling, general and administrative
—
4,933
1,925
Share-based compensation expense from discontinued operations
—
8,188
6,577
Total share-based compensation expense
$
96,637 $
100,905 $
94,254
During the years ended December 31, 2024, 2023 and 2022, $3.1 million, $3.2 million and $3.3 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 May 31, 2024, the Company’s shareholders approved an amended version of the then-current version of the 2018 Plan that served to, among
other things, increase the number of ordinary shares authorized for issuance thereunder by 6.3 million. At December 31, 2024, there were 17.9 million
ordinary shares available for issuance in the aggregate under the 2018 Plan. The 2018 Plan provides that awards other than stock options will be counted
against the total number of shares available under the plan in a 1.8-to-1 ratio.
Stock Options
A summary of stock option activity is presented in the following table:
Number of
Weighted Average
Shares
Exercise Price
Outstanding, January 1, 2024
18,139,903 $
32.28
Granted
2,615,357 $
29.48
Exercised
(1,328,189 ) $
20.76
Expired
(1,427,409 ) $
46.72
Forfeited
(521,043 ) $
26.65
Outstanding, December 31, 2024
17,478,619 $
31.73
Exercisable, December 31, 2024
10,979,663 $
34.53
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-28
The weighted average grant date fair value of stock options granted during the years ended December 31, 2024, 2023 and 2022 was $14.08, $13.74
and $12.62, respectively. The aggregate intrinsic value of stock options exercised during the years ended December 31, 2024, 2023 and 2022 was $10.9
million, $6.0 million and $11.6 million, respectively.
At December 31, 2024, there were 6.3 million stock options expected to vest, with a weighted average exercise price of $26.91 per share, a weighted
average contractual remaining life of 7.9 years and an aggregate intrinsic value of $15.4 million. At December 31, 2024, the aggregate intrinsic value of
stock options exercisable was $38.5 million with a weighted average remaining contractual term of 4.4 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, 2024, there was $32.3 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, 2024
5,657,578 $
24.18
Granted
2,260,345 $
29.51
Forfeited
(775,415 ) $
26.43
Vested
(2,237,302 ) $
23.05
Unvested, December 31, 2024
4,905,206 $
26.80
The weighted average grant date fair values of time-vesting RSUs granted during the years ended December 31, 2024, 2023 and 2022 were $29.51,
$27.65 and $25.27, respectively. The total fair value of time-vesting RSUs that vested during the years ended December 31, 2024, 2023 and 2022, was
$51.6 million, $63.0 million and $54.3 million, respectively.
At December 31, 2024, there was $53.4 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 2024, 2023 and 2022, the compensation committee of the Company’s board of directors approved the Company’s long-term incentive
plans, pursuant to which awards of performance-based RSUs are granted to employees of the Company at the Senior Vice President level and above, in
each case subject to vesting based on the achievement of certain financial, commercial and/or R&D performance criteria to be assessed over a performance
period of three years from the date of the grant, and subject, at the end of such three-year performance period, to upward or downward adjustment based on
a market condition tied to relative share price performance over the three-year performance period.
A summary of performance-based RSU activity is presented in the following table:
Weighted Average
Number of
Shares
Grant Date
Fair Value
Unvested, January 1, 2024
1,546,357
$
27.95
Granted
498,120
$
32.46
Forfeited
(172,576 ) $
25.88
Vested
(536,243 ) $
22.21
Unvested, December 31, 2024
1,335,658
$
32.13
The weighted average grant date fair values of performance-based RSUs granted during the years ended December 31, 2024, 2023 and 2022 were
$32.46, $29.91 and $30.73, respectively. The total fair value of performance-based RSUs that vested during the years ended December 31, 2024, 2023 and
2022 were $10.1 million, $5.9 million and none, respectively. At December 31, 2024, there
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-29
was $3.0 million of unrecognized share-based compensation expense related to unvested performance-based RSUs which would be recognized in
accordance with the terms of the awards when the Company deems it probable that the performance criteria will be met.
During the year ended December 31, 2024, the Company recognized share-based compensation expense related to certain performance-based RSUs
that were granted during 2021. As of December 31, 2023, the financial performance criteria for these awards were deemed not probable of being achieved;
however, in February 2024, the compensation committee of the Company’s board of directors determined that the Company partially achieved the financial
performance criteria. This was considered a modification in accordance with FASB ASC 718, Compensation—Stock Compensation and resulted in a
modification charge of approximately $6.8 million. In February 2024, the compensation committee of the Company’s board of directors also determined
that the Company achieved the pipeline performance criteria for these awards, resulting in a $2.6 million incremental share-based compensation expense,
as it was deemed such pipeline performance criteria had been met. The share-based compensation expense related to these achievements was 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, 2024, 2023 and 2022 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 with valid claims applicable to the product in such country. The know-how royalty is a
tiered royalty of 3.5%, 5.5% and 7.5% on aggregate worldwide net sales of below $250 million, between $250 million and $500 million, and greater than
$500 million, respectively. 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.
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.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-30
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. 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. 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 are subject to customary reductions, as set forth in the license and collaboration agreement.
Following FDA approval of VUMERITY and, except for the manufacturing responsibilities discussed below, Biogen is now responsible for all
development and commercialization activities for VUMERITY and all other products covered by the patents that we licensed to Biogen.
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. In October 2019, the
Company entered into a commercial supply agreement with Biogen for the commercial supply of VUMERITY, an amendment to such commercial supply
agreement and an amendment to the license and collaboration agreement with Biogen, pursuant to which Biogen has conducted a technology transfer and,
following an agreed transition period, has elected to assume responsibility for the manufacture (itself or through a designee) of clinical and commercial
supplies of VUMERITY in exchange for an increase in the royalty rate to be paid by Biogen to the Company on net sales of product that is manufactured
by Biogen or its designee. In May 2024, the Company completed the sale of the Athlone Facility where VUMERITY is manufactured. In connection with
the sale of the Athlone Facility, the Company has entered into a subcontracting arrangement with the purchaser of the Athlone Facility for the manufacture
of VUMERITY through the manufacturing transition period, which may continue through the end of 2025.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-31
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 provision (benefit) for income taxes from continuing operations consists of the following:
Year Ended December 31,
(In thousands)
2024
2023
2022
Current income tax provision (benefit):
U.S. federal
$
25,640 $
(981 ) $
11,169
U.S. state
4,259
722
4,401
Ireland
1,192
—
—
Deferred income tax provision (benefit):
U.S. federal
(19,870 )
10,192
(10,536 )
U.S. state
(1,392 )
(507 )
(3,010 )
Ireland
61,783
(107,064 )
—
Total tax provision (benefit)
$
71,612 $
(97,638 ) $
2,024
(1)
Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation.
The income tax provision in 2024 was primarily due to taxes on income earned in Ireland. The income tax benefit in 2023 was primarily due to the
partial release of the valuation allowance maintained against certain Irish deferred tax assets, partially offset by taxes on income earned in the U.S. and
Ireland. The income tax expense in 2022 was primarily due to taxes on income earned in the U.S.
In December 2022, the EU implemented a new corporate minimum tax rate of 15% on companies with consolidated annual revenue of at least
€750.0 million, which was transposed into Irish law effective as of January 1, 2024. The Company has determined that this new minimum tax had no
material impact for the year ended December 31, 2024.
The income tax benefit associated with the Company’s former oncology business, and the tax impact of the Separation, are discussed in further
detail in Note 3, Discontinued Operations, in these “Notes to Consolidated Financial Statements” in this Annual Report. The tax benefits included within
discontinued operations were $0.7 million, $1.4 million, and $11.1 million for the years ended December 31, 2024, 2023, and 2022, respectively.
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 $933.5 million at December
31, 2024. 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
$72.0 million of income taxes would be payable on the repatriation of the unremitted earnings to Ireland.
The distribution of the Company’s income (loss) before the provision (benefit) for income taxes by geographical area consists of the following:
Year Ended December 31,
(In thousands)
2024
2023
2022
Ireland
$
440,674 $
411,767 $
(32,198 )
U.S.
3,076
9,752
1,070
Income (loss) from continuing operations before provision (benefit) for income taxes
$
443,750 $
421,519 $
(31,128 )
(1)
Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation.
(1)
(1)
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-32
The components of the Company’s net deferred tax assets consist of the following:
December 31,
December 31,
(In thousands)
2024
2023
Deferred tax assets:
Net operating loss carryforwards
$
80,209 $
195,658
Research and development expenses
71,167
49,206
Accrued expenses and reserves
41,189
37,367
Operating lease liabilities
17,537
18,716
Share-based compensation
33,773
37,727
Tax credits
26,882
27,116
Other
3,695
5,582
Less: valuation allowance
(79,727 )
(129,296 )
Total deferred tax assets
194,725
242,076
Deferred tax liabilities:
Property, plant and equipment
(21,917 )
(26,271 )
Right-of-use assets
(16,337 )
(17,748 )
Other
(1,940 )
(2,716 )
Total deferred tax liabilities
(40,194 )
(46,735 )
Net deferred tax assets
$
154,531 $
195,341
The activity in the valuation allowance associated with deferred taxes consists of the following:
(In thousands)
Balance at
Beginning of
Period
(Additions) /
Reductions
Balance at End of
Period
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 )
Deferred tax asset valuation allowance for the year ended December 31, 2024
$
(129,296 ) $
49,569 $
(79,727 )
(1)
Inclusive of continuing and discontinued operations for the periods prior to the Separation in November 2023.
(2)
(Additions) reductions represent continuing and discontinued operations for the periods prior to the Separation in November 2023. The reductions during the year ended December
31, 2024 primarily relate to the abandonment of certain Irish NOLs following the sale of the Athlone Facility to Novo. These NOLs were transferred from Elan Corporation, plc as
part of the combination of the drug technology business of Elan Corporation, plc with the business of Alkermes, Inc. A number of restrictions applied to these NOLs thereby
restricting the Company’s ability to utilize such NOLs. Following the sale of the Athlone Facility, the Company believes that its ability to utilize these NOLs is remote. The
reduction during the year ended December 31, 2023 primarily relates to the partial release of the valuation allowance maintained by the Company against certain Irish net deferred
tax assets. The additions in 2022 relate primarily to Irish NOLs.
The Company regularly assesses the need for a valuation allowance against its deferred tax assets. In making such assessment, the Company
considers both positive and negative evidence related to the likelihood of realization of the deferred tax assets to determine, based on the weight of
available evidence, whether it is more-likely-than-not that some or all of the deferred tax assets will not be realized. At December 31, 2024, the Company
maintained a valuation allowance of $29.6 million against certain U.S. state deferred tax assets and $50.1 million against certain Irish deferred tax assets, as
the Company has determined that it is more-likely-than-not that these deferred tax assets will not be realized and some may be abandoned.
If the Company incurs losses in the U.S. or in Ireland in the future, or fails to achieve sufficient profitability in a timely manner, the evaluation of
the recoverability of the deferred tax assets could change and a valuation allowance against such deferred tax assets may be required in part or in whole.
The Company will continue to monitor the need for a valuation allowance against its deferred tax assets on a quarterly basis.
As of December 31, 2024, the Company had $393.9 million of Irish NOL carryforwards, $14.1 million of U.S. federal NOL carryforwards, $43.2
million of state NOL carryforwards and $34.0 million of state tax credits which will either expire on various dates through 2039 or can be carried forward
indefinitely. These loss and credit carryforwards are available to reduce certain future Irish and foreign taxable income and tax. These loss and credit
carryforwards are subject to review and possible adjustment by the appropriate taxing authorities and may be subject to limitations based upon changes in
the ownership of the Company’s ordinary shares. Included within these loss and credit carryforwards are $14.1 million of U.S. federal NOL carryforwards
and $5.8 million of state NOL carryforwards, acquired as part of the acquisition of Rodin Therapeutics, Inc. in November 2019, each of which are subject
to a $0.5 million annual limitation.
(1)
(2)
(1)
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-33
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)
2024
2023
2022
Statutory tax rate
12.5 %
12.5 %
12.5 %
Income (loss) from continuing operations before income taxes at statutory rate
$
55,469
$
52,690
$
(3,891 )
Share-based compensation
5,607
4,177
4,347
Foreign rate differential
4,844
4,701
521
Change in valuation allowance
(49,517 )
(142,424 )
1,102
Intercompany amounts
708
(16,551 )
(1,694 )
Irish rate differential
5,798
235
4,926
Uncertain tax positions
(667 )
(234 )
602
Non-deductible lobbying expenses
767
705
775
U.S. state income taxes, net of U.S. federal benefit
2,802
347
1,272
Foreign derived intangible income
(281 )
—
(4,530 )
R&D credit
(7,815 )
(2,823 )
(2,531 )
Abandonment of NOLs
49,897
—
—
Other permanent items
4,000
1,539
1,125
Income tax provision (benefit)
$
71,612
$
(97,638 )
$
2,024
Effective tax rate
16.1 %
(23.2 ) %
(6.5 ) %
(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 abandonment of Irish NOLs following the sale of the Athlone Facility to Novo.
(6)
Other permanent items include, but are not limited to, non-deductible meals and entertainment expenses and non-deductible compensation of senior officers of the Company. For
the year ended December 31, 2024, permanent items also included amounts relating to the sale of the Athlone Facility.
A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows:
Unrecognized
(In thousands)
Tax Benefits
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
Reductions based on the lapse of applicable statutes of limitations
(1,306 )
Additions based on tax positions related to the prior period
59
Additions based on tax positions related to the current period
581
Balance, December 31, 2024
$
8,073
The unrecognized tax benefits at December 31, 2024, 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, 2024, 2023 and
2022, the Company’s accrued interest and penalties related to uncertain tax positions were not material.
(1)
(2)
(3)
(4)
(5)
(6)
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-34
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 2021 through 2024 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 2020 through 2024 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.
18. SEGMENT REPORTING
Segment Information
Following the adoption of ASU 2023-07, the Company is required to disclose significant segment expenses that are regularly provided to the
CODM. The Company’s CODM is periodically provided R&D expenses, selling and marketing expenses, and general and administrative expenses. Other
external R&D expenses are composed of general research and development expenses and other external projects. Other internal R&D expenses include
allocation expenses, travel expenses, and fees, taxes and dues.
The Company’s significant segment expenses are as follows:
Year Ended December 31,
(In thousands)
2024
2023
2022
REVENUES:
Total revenue
$
1,557,632
$
1,663,405 $
1,111,795
EXPENSES:
Cost of goods manufactured and sold (exclusive of amortization of
acquired intangible assets shown below)
245,331
253,037
218,068
External R&D expenses:
Development programs:
ALKS 2680
45,947
31,321
15,715
LYBALVI
18,737
15,379
23,056
Other external R&D expenses
36,627
51,668
57,423
Total external R&D expenses
101,311
98,368
96,194
Internal R&D expenses:
Employee-related
114,496
128,282
129,735
Occupancy
11,206
12,299
12,449
Depreciation
5,701
9,578
10,708
Other internal R&D expenses
12,612
22,279
23,616
Total internal R&D expenses
144,015
172,438
176,508
R&D expenses
245,326
270,806
272,702
Selling, general and administrative expenses:
Selling and marketing expense
446,214
490,154
392,211
General and administrative expense
199,024
199,597
198,540
Total selling, general and administrative expense
645,238
689,751
590,751
Other segment (expenses) income
(49,599 )
69,346
(63,426 )
NET INCOME (LOSS) FROM CONTINUING OPERATIONS
372,138
519,157
(33,152 )
LOSS ON DISCONTINUED OPERATIONS, NET OF TAX
(5,068 )
(163,400 )
(125,115 )
NET INCOME (LOSS)
$
367,070
$
355,757 $
(158,267 )
(1)
“Other segment (expenses) income” during the years ended December 31, 2024, 2023 and 2022 includes “Amortization of acquired intangible assets”, “Other income (loss), net”
and “Income tax provision (benefit)”.
(1)
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-35
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, 2024, there were no potential material losses from claims, asserted or unasserted, or legal proceedings
that the Company determined were probable of occurring.
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”). A bench trial is scheduled to begin on July 28, 2025.
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.
Product Liability and Other Legal Proceedings
The Company is involved in litigation and other legal proceedings incidental to its normal business activities, including a product liability case
alleging that the FDA-approved VIVITROL labeling was inadequate and that VIVITROL caused the individual to suffer from opioid overdose and death.
The Company intends to vigorously defend itself in these matters.
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 Court”), and the Company filed a motion
to transfer the appeal to the U.S. Court of Appeals for the Second Circuit. In January 2024, the Federal Circuit Court denied without prejudice the
Company’s motion to transfer the appeal and instructed the parties to brief the jurisdictional question as part of the merits appeal. Briefing in the Federal
Circuit Court is complete, and the matter is pending decision.
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
F-36
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, 2024, the fair value of the guarantee was not 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, 2024, the Company’s
open purchase orders were $17.7 million for capital commitments.
Exhibit 4.1
DESCRIPTION OF ALKERMES PLC ORDINARY SHARES
The following is a summary description of the ordinary shares of Alkermes plc. This summary does not purport to be complete and is
qualified in its entirety by reference to the Irish Companies Act 2014 (the “Companies Act”) and the complete text of our memorandum and
articles of association, as they may be amended from time to time (together, our “Constitution”). A copy of our Constitution is incorporated
by reference as Exhibit 3.1 to the Annual Report on Form 10-K of which this Exhibit 4.1 is a part. You should read the Companies Act and
our Constitution carefully. Use of terms such as “us,” “we,” “our,” “Alkermes” or the “Company” in this Exhibit 4.1 is meant to refer to
Alkermes plc.
Capital Structure
Authorized Share Capital
Our authorized share capital is €40,000 and $5,000,000, which is divided into 40,000 ordinary shares of €1.00 each, 450,000,000
ordinary shares of $0.01 each and 50,000,000 undesignated preferred shares of $0.01 each. Our ordinary shares are registered under Section
12(b) of the Securities Exchange Act of 1934, as amended.
We may issue shares subject to the maximum authorized share capital contained in our Constitution, and subject to the issuance and
allotment authorities approved by our shareholders. Our authorized share capital may be increased or reduced by a resolution approved by a
simple majority of the votes of our shareholders cast in person or by proxy at a general meeting (referred to under Irish law as an “ordinary
resolution”). As a matter of Irish law, the board of directors of a public limited company (“plc”) like Alkermes may issue new ordinary or
preferred shares without shareholder approval once authorized to do so by the company’s constitution or by an ordinary resolution adopted
by the company’s shareholders at a general meeting. The authorization may be granted for a maximum period of five years, after which it
must be renewed by the shareholders by an ordinary resolution. In May 2024, our shareholders authorized our board of directors (the
“Board”) to allot and issue ordinary shares in an amount equal to approximately 20% of our issued ordinary share capital as of April 10,
2024. This current authorization extends until November 30, 2025, at which point it will lapse unless renewed by our shareholders.
The rights and restrictions applicable to our ordinary shares are prescribed in our Constitution. Our Constitution permits the Board,
without shareholder approval, to determine the terms of any preferred shares issued by us. Our Board is authorized, without obtaining any
vote or consent of the holders of any class or series of shares, unless expressly provided by the terms of that class or series of shares, to
provide from time to time for the issuance of other classes or series of preferred shares and to establish the characteristics of each class or
series, including the number of shares, designations, relative voting rights, dividend rights, liquidation and other rights, redemption,
repurchase or exchange rights and any other preferences and relative, participating, optional or other rights and limitations not inconsistent
with applicable law.
Irish law does not recognize fractional shares held of record. Accordingly, our Constitution does not provide for the issuance of
fractional shares, and our official Irish register of members (shareholders) will not reflect any fractional shares.
Pre-emption Rights, Share Warrants and Share Options
Under Irish law, unless otherwise authorized, when an Irish plc issues shares for cash to new shareholders, it is required to first offer
those shares on the same or more favorable terms to existing shareholders of the company on a pro rata basis (commonly referred to as the
“statutory pre-emption right”). However, Irish law permits such companies to opt out of the statutory pre-emption right for a period of up to
five years if authorized by a resolution approved by not less than 75% of the votes of the company’s shareholders cast in person or by proxy
at a general meeting (referred to under Irish law as a “special resolution”). In May 2024, our shareholders authorized our Board to allot and
issue shares for cash on a non-pre-emptive basis up to the amount of approximately 20% of our issued share capital as of April 10, 2024. This
current authorization extends until November 30, 2025, at which point it will lapse unless renewed by our shareholders. The statutory pre-
emption right does not apply where shares are issued for non-cash consideration (such as in a stock-for-stock acquisition) and does not apply
to the issue of non-equity shares (that is, shares that have the right to participate only up to a specified amount in any income or capital
distribution) or where shares are issued pursuant to an employee stock option or similar equity plan.
Our Constitution provides that, subject to any shareholder approval requirement under any laws, regulations or the stock exchange
rules to which we are subject, the Board is authorized, from time to time, in its discretion, to grant such persons, for such periods and upon
such terms as the Board deems advisable, options to purchase such number of shares of any class or classes or of any series of any class as
the Board may deem advisable, and to cause warrants or other appropriate instruments evidencing such options to be issued. The Companies
Act provides that a board of directors may issue share warrants or options without shareholder approval once authorized to do so by its
constitution or an ordinary resolution of shareholders. We are subject to the applicable rules and regulations of The Nasdaq Stock Market
(“Nasdaq”) and the Internal Revenue Code of 1986, as amended, that require shareholder approval of certain equity plan and share issuances.
Our Board may issue shares upon exercise of warrants or options without shareholder approval or authorization (up to the relevant authorized
share capital limit).
Dividends
Under Irish law, dividends and distributions may only be made from distributable reserves. Distributable reserves generally means
accumulated realized profits less accumulated realized losses and includes reserves created by way of capital reduction. In addition, no
distribution or dividend may be made unless our net assets are equal to, or in excess of, the aggregate of our called-up share capital plus
undistributable reserves and the distribution does not reduce our net assets below such aggregate. Undistributable reserves include: (i) our
undenominated capital; (ii) the amount by which our accumulated unrealized profits, so far as not previously utilized by any capitalization,
exceed our accumulated unrealized losses, so far as not previously written off in a reduction or reorganization of capital; and (iii) any other
reserve we are prohibited, at law, from distributing.
The determination as to whether or not we have sufficient distributable reserves to fund a dividend must be made by reference to our
“relevant accounts.” The “relevant accounts” will be either the last set of unconsolidated annual audited financial statements or other
financial statements properly prepared in accordance with the Companies Act, which give a “true and fair view” of our unconsolidated
financial position and accord with accepted accounting practice. The relevant accounts must be filed in the Companies Registration Office
(the official public registry for companies in Ireland).
Our Constitution authorizes the Board to declare dividends out of funds lawfully available for distribution without shareholder
approval to the extent they appear justified by the profits of the Company. The Board may also recommend a dividend to be approved and
declared by the shareholders at
a general meeting. The Board may direct that the payment be made by distribution of assets, shares or cash and no dividend issued may
exceed the amount recommended by the Board. Dividends may be declared and paid in the form of cash or non-cash assets and may be paid
in United States Dollars or any other currency.
Our Board may deduct from any dividend payable to any shareholder any amounts payable by such shareholder to us in relation to our
shares.
The Board may also authorize us to issue shares with preferred rights to participate in dividends we declare. The holders of preferred
shares may, depending on their terms, rank senior to our ordinary shares in terms of dividend rights and/or be entitled to claim arrears of a
declared dividend out of subsequently declared dividends in priority to ordinary shareholders.
Share Repurchases, Redemptions and Conversions
Overview
Our Constitution provides that any ordinary share that we have agreed to acquire shall be deemed to be a redeemable share, unless the
Board elects to treat such share acquisition otherwise. Accordingly, for Irish law purposes, repurchases of ordinary shares by us are effected
as redemptions of those shares as described below under “—Our Repurchases and Redemptions.” If our Constitution did not contain such
provision, our repurchases would be subject to many of the same rules that apply to purchases of our ordinary shares by subsidiaries
described below under “—Purchases by Our Subsidiaries” including the shareholder approval requirements described below and the
requirement that any open-market purchases be effected on a “recognized stock exchange.” Except where otherwise noted, references herein
to repurchasing or buying back our ordinary shares refer to our or one of our subsidiaries’ redemption of ordinary shares, in each case in
accordance with our Constitution and Irish law as described below.
Our Repurchases and Redemptions
Under Irish law, a company may issue redeemable shares and redeem them out of distributable reserves or the proceeds of a new issue
of shares for that purpose. Please see also the “—Dividends” section above. We may only issue redeemable shares if the nominal value of the
issued share capital that is not redeemable is not less than 10% of the nominal value of our total issued share capital. All redeemable shares
must also be fully-paid. Redeemable shares may, upon redemption, be canceled or held in treasury. Based on the provision of our
Constitution described above, shareholder approval is not required to redeem our shares.
We may also be given an additional general authority to purchase our own shares on-market which would take effect on the same
terms and be subject to the same conditions as applicable to purchases by our subsidiaries as described below.
Our Board may also issue preferred shares that may be redeemed at our option or the option of the preferred shareholder, depending on
the terms of such preferred shares. Please see “—Authorized Share Capital” above for additional information on preferred shares.
Under Irish law, repurchased and redeemed shares may be canceled or held as treasury shares. The nominal value of treasury shares
held by us at any time must not exceed 10% of the nominal value of our issued share capital. We may not exercise any voting rights in
respect of any shares held as treasury shares. Treasury shares may be canceled by us or re-issued subject to certain conditions.
Purchases by Our Subsidiaries
Under Irish law, a subsidiary may purchase our shares either on-market (an overseas market purchase) or off-market. For one of our
subsidiaries to make on-market purchases of our ordinary shares, our shareholders must provide general authorization for such purchase by
way of ordinary resolution. However, as long as this general authority has been granted, no specific shareholder authority is required for a
particular on-market purchase of our ordinary shares by one of our subsidiaries. For an off-market purchase by one of our subsidiaries, the
proposed purchase contract must be authorized by special resolution of our shareholders before the contract is entered into. The person whose
shares are to be bought back cannot vote in favor of the special resolution and, for at least 21 days prior to the special resolution being
passed, the purchase contract must be on display or must be available for inspection by shareholders at our registered office.
In order for one of our subsidiaries to make an overseas market purchase of our shares, such shares must be purchased on a
“recognized stock exchange.” The Nasdaq Global Select Market, on which our shares are listed, is specified as a recognized stock exchange
for this purpose by Irish law.
The number of shares held by our subsidiaries at any time will be included in any calculation of the permitted treasury share threshold
of 10% of the nominal value of our issued share capital. While a subsidiary holds our shares, it cannot exercise any voting rights in respect of
those shares. The acquisition of our shares by a subsidiary must be funded out of distributable reserves of the subsidiary.
Share Repurchase Program
On February 15, 2024, our Board authorized a share repurchase program to repurchase our ordinary shares in an aggregate amount of
up to $400.0 million (exclusive of any fees, commissions or other expenses related to such repurchases) from time to time on the open market
(the “Repurchase Program”), with the timing and amount of any repurchases under the Repurchase Program to be based on a variety of
factors, including but not limited to ongoing assessments of our capital needs, alternative investment opportunities, the market price of our
ordinary shares and general market conditions. The Repurchase Program has no set expiration date and may be suspended or discontinued at
any time. During the year ended December 31, 2024, we repurchased approximately 7.9 million of our ordinary shares under the Repurchase
Program at an average price of $25.33, at a total cost (exclusive of any fees, commissions or other expenses related to such repurchase) of
$200.0 million. The Repurchase Program terminated, and superseded in its entirety, the prior share repurchase program authorized by our
Board in September 2011, under which we had purchased a total of 8,866,342 ordinary shares at a cost of $114.0 million.
As noted above, shareholder approval for repurchases under the Repurchase Program will not be required because all repurchases of
our shares under the Repurchase Program will be effected as redemptions pursuant to our Constitution.
Bonus Shares
Under our Constitution, the Board may resolve to capitalize any amount standing to the credit of the reserves of the Company
(including, but not limited to, the share premium account, capital redemption reserve, capital conversion reserve and profit and loss account),
whether or not available for distribution, for any purpose, including, but not limited to, for the purposes of effecting any exchange of any
rights and applying any such sum arising from such capitalization to pay up any shares of the Company and allot them, credited as fully paid,
to any holders of such rights.
Lien on Shares, Calls on Shares and Forfeiture of Shares
Our Constitution provides that we will have a first and paramount lien on every share that is not a fully paid up share for all amounts
payable at a fixed time or called in respect of that share. Subject to the terms of their allotment, our Board may call for any unpaid amounts in
respect of any shares to be paid, and if payment is not made, the shares may be forfeited. These provisions are standard inclusions in the
constitution of an Irish company limited by shares such as ours and will only be applicable to our shares that have not been fully paid up.
Consolidation and Division; Subdivision
Under our Constitution, we may, by ordinary resolution, consolidate and divide all or any of our share capital into shares of larger
nominal value than our existing shares or subdivide our shares into smaller amounts than is fixed by our Constitution.
Reduction of Share Capital
We may, by ordinary resolution, reduce our authorized share capital in any way, provided that such resolution does not reduce the
authorized share capital to an amount less than the issued share capital at such time. We also may, by special resolution and subject to
confirmation by the Irish High Court, reduce or cancel our issued share capital in any way we think expedient.
Annual Meetings of Shareholders
We are required to hold annual general meetings at intervals of no more than 15 months, provided that an annual general meeting is
held in each calendar year and no more than nine months after our fiscal year-end. Any annual general meeting may be held outside Ireland,
provided that the Company makes all necessary arrangements to ensure that shareholders can participate in such meeting by technological
means without leaving Ireland.
Notice of each annual general meeting must be given to all our shareholders and to our auditors. Our Constitution provides for a
minimum notice period of 21 clear days (as defined in our Constitution), which is the minimum permitted under Irish law.
The only matters which must, as a matter of Irish law, be transacted at an annual general meeting are: (i) the consideration of the
Company’s statutory financial statements and the reports of our Board and our statutory auditors thereon; (ii) the review by our shareholders
of the Company’s affairs; (iii) the authorization of our Board to approve the remuneration of the statutory auditors; and (iv) the election
and/or re-election of members of our Board in accordance with our Constitution. If no resolution is made in respect of the reappointment of
an existing auditor at an annual general meeting, the existing auditor will be deemed to have continued in office.
Extraordinary General Meetings of Shareholders
Extraordinary general meetings may be convened by: (i) our Board; (ii) at the request of shareholders holding not less than 10% of our
paid-up share capital carrying voting rights; or (iii) at the request of our auditors in certain circumstances in accordance with the Companies
Act. Extraordinary general meetings are generally held for the purposes of approving Board or shareholder resolutions as may be required
from time to time. At any extraordinary general meeting, only such business shall be conducted as is set forth in the notice thereof.
Notice of an extraordinary general meeting must be given to our shareholders and to our auditors. Under Irish law and our
Constitution, the minimum notice periods are 21 clear days’ notice in writing for
an extraordinary general meeting to approve a special resolution and 14 clear days’ notice in writing for any other extraordinary general
meeting.
In the case of an extraordinary general meeting convened on the requisition of our shareholders, the proposed purpose of the meeting
must be set out in the requisition notice. Upon receipt of this required notice, the Board has 21 days to convene a meeting of our shareholders
to vote on the matters set out in the required notice. This meeting must be held within two months of the receipt of the requisition notice. If
the Board does not convene the meeting within such 21-day period, the requisitioning shareholders, or any of them representing more than
one half of the total voting rights of all of them, may themselves convene a meeting, which meeting must be held within three months of our
receipt of the requisition notice.
If the Board becomes aware that our net assets are not greater than half of the amount of our called-up share capital, our Board must
convene an extraordinary general meeting of our shareholders not later than 28 days from the date that they learn of this fact to consider how
to address the situation.
Quorum for General Meetings
Our Constitution provides that no business shall be transacted at any general meeting unless a quorum is present. One or more
shareholders present in person or by proxy holding not less than a majority of our issued and outstanding shares entitled to vote at the
meeting in question constitute a quorum for such meeting.
Voting
Our Constitution provides that the Board or the chairman of the Board may determine the manner in which the poll is to be taken at
each meeting and the manner in which the votes are to be counted.
Every shareholder is entitled to one vote for each ordinary share that they hold as of the record date for the meeting. Voting rights may
be exercised by shareholders registered in our share register as of the record date for the meeting or by a duly appointed proxy, which proxy
need not be a shareholder. Where interests in shares are held by a nominee trust company, this company may exercise the rights of the
beneficial holders on their behalf as their proxy. All proxies must be appointed in the manner prescribed by our Constitution, which permit
shareholders to notify us of their proxy appointments electronically in such manner as may be approved by the Board.
In accordance with our Constitution, our Board may from time to time authorize us to issue preferred shares. These preferred shares
may have such voting rights as may be specified in the terms of such preferred shares (e.g., they may carry more votes per share than
ordinary shares or may entitle their holders to a class vote on such matters as may be specified in the terms of the preferred shares). Treasury
shares or shares of the Company that are held by our subsidiaries will not be entitled to be voted at general meetings of shareholders.
Irish law requires special resolutions of the shareholders at a general meeting to approve certain matters. Examples of matters requiring
special resolutions include:
a)
amending our Constitution;
b)
approving a change of our name;
c)
authorizing the entering into of a guarantee or provision of security in connection with a loan, quasi-loan or credit transaction to a
director or connected person;
d)
opting out of pre-emption rights on the issuance of new shares;
e)
creating a new class of shares;
f)
re-registration from a public limited company to a private company;
g)
variation of class rights attaching to classes of shares (where the Constitution does not provide otherwise);
h)
purchase of our own shares off-market;
i)
reduction of issued share capital;
j)
sanctioning a compromise/scheme of arrangement;
k)
resolving that we be wound up by the Irish courts;
l)
resolving in favor of a shareholders’ voluntary winding-up;
m) re-designation of shares into different share classes; and
n)
setting the re-issue price of treasury shares.
Variation of Rights Attaching to a Class or Series of Shares
Under our Constitution and the Companies Act, any variation of class rights attaching to our issued shares must be approved by a
special resolution of the shareholders of the affected class or with the consent in writing of the holders of three-quarters of all the votes of
that class of shares.
The provisions of our Constitution relating to general meetings apply to general meetings of the holders of any class of shares except
that the necessary quorum is determined by reference to the shares of the holders of the applicable class. Accordingly, for general meetings of
holders of a particular class of shares, a quorum consists of the holders present in person or by proxy representing not less than a majority of
the issued shares of that class entitled to vote at the meeting.
Acquisitions
An Irish public limited company may be acquired in a number of ways, including:
a)
a court-approved scheme of arrangement under the Companies Act. A scheme of arrangement with shareholders requires a court
order from the Irish High Court and the approval of a majority in number representing 75% in value of the shareholders present and
voting in person or by proxy at a meeting called to approve the scheme;
b)
through a tender or takeover offer by a third party for all of our shares. Where the holders of 80% or more of our shares have
accepted an offer for such shares, the remaining shareholders may also be statutorily required to transfer their shares. If the bidder
does not exercise its “squeeze out” right, then the non-accepting shareholders also have a statutory right to require the bidder to
acquire their shares on the same terms. If our shares were to be listed on the Irish Stock Exchange or another regulated stock
exchange in the EU, this threshold would be increased to 90%; and
c)
by way of a merger with a company incorporated in the European Economic Area (“EEA”) under the EU Cross-Border Mergers
Directive (EU) 2017/1132 or with another Irish company under the Companies Act. Such a merger must be approved by a special
resolution of the shareholders. Under certain circumstances, shareholders also may be entitled to have their shares acquired for cash.
Irish law does not generally require shareholder approval for a sale, lease or exchange of all or substantially all of a company’s
property and assets.
Appraisal Rights
Irish law generally does not provide for “appraisal rights”. However, it does provide for dissenters’ rights in certain situations, as
described below.
Under a tender or takeover offer, the bidder may require any remaining shareholders to transfer their shares on the terms of the offer
(i.e., a “squeeze out”) if it has acquired, pursuant to the offer, not less than 80% of the target shares to which the offer relates (in the case of a
company like Alkermes that is not listed on an EEA regulated market). Dissenting shareholders have the right to apply to the Irish High
Court for relief.
A scheme of arrangement which has been approved by the requisite shareholder majority and sanctioned by the Irish High Court will be
binding on all shareholders. Dissenting shareholders have the right to appear at the Irish High Court hearing and make representations in
objection to the scheme.
Under the European Communities (Cross-Border Mergers) Regulations 2008 governing the merger of an Irish company limited by
shares such as we are and a company incorporated in the EEA, a shareholder: (i) who voted against the special resolution approving the
merger; or (ii) of a company in which 90% of the shares are held by the other party to the merger, has the right to request that the company
acquire its shares for cash at a price determined in accordance with the share exchange ratio set out in the merger agreement.
Similar rights apply in the case of a merger of an Irish plc into another company to which the provisions of the Companies Act apply.
Disclosure of Interests in Shares
Under the Companies Act, shareholders must notify us if, as a result of a transaction, the shareholder will become interested in 3% or
more of our shares; or if as a result of a transaction a shareholder who was interested in more than 3% of our shares ceases to be so interested.
Where a shareholder is interested in more than 3% of our shares, the shareholder must notify us of any alteration of his or her interest that
brings his or her total holding through the nearest whole percentage number, whether an increase or a reduction. The relevant percentage
figure is calculated by reference to the aggregate nominal value of the shares in which the shareholder is interested as a proportion of the
entire nominal value of our issued share capital of (or any such class of share capital in issue). Where the percentage level of the
shareholder’s interest does not amount to a whole percentage this figure may be rounded down to the next whole number. We must be
notified within five business days of the transaction or alteration of the shareholder’s interests that gave rise to the notification requirement. If
a shareholder fails to comply with these notification requirements, the shareholder’s rights in respect of any shares it holds will not be
enforceable, either directly or indirectly. However, such person may apply to the court to have the rights attaching to such shares reinstated.
In addition to these disclosure requirements, we may, under the Companies Act, by notice in writing, require a person whom we know
or have reasonable cause to believe to be, or at any time during the three years immediately preceding the date on which such notice is issued
to have been, interested in shares comprised in our relevant share capital to: (i) indicate whether or not it is the case; and (ii) where such
person holds or has during that time held an interest in our shares, to provide additional information, including the person’s own past or
present interests in our shares. If the recipient of the notice fails to respond within the reasonable time period specified in the notice, we may
apply to court for an order
directing that the affected shares be subject to certain restrictions, as prescribed by the Companies Act, as follows:
a)
any transfer of those shares or, in the case of unissued shares, any transfer of the right to be issued with shares and any issue of
shares, shall be void;
b)
no voting rights shall be exercisable in respect of those shares;
c)
no further shares shall be issued in right of those shares or in pursuance of any offer made to the holder of those shares; and
d)
no payment shall be made of any sums due from us on those shares, whether in respect of capital or otherwise.
The court may also order that shares subject to any of these restrictions be sold with the restrictions terminating upon the completion of
the sale.
In the event that we are in an offer period pursuant to the Irish Takeover Rules made under the Irish Takeover Panel Act 1997 (the
“Irish Takeover Rules”), accelerated disclosure provisions apply for persons holding an interest in our securities of 1% or more.
In addition, the beneficial ownership disclosure requirements of U.S. federal securities laws apply with respect to beneficial ownership
of our shares.
Anti-Takeover Provisions
Irish Takeover Rules and Substantial Acquisition Rules
A transaction in which a third party seeks to acquire 30% or more of our voting rights will be governed by the Irish Takeover Panel
Act 1997 and the Irish Takeover Rules made thereunder and will be regulated by the Irish Takeover Panel. The “General Principles” of the
Irish Takeover Rules and certain important aspects of the Irish Takeover Rules are described below.
General Principles
The Irish Takeover Rules are built on the following general principles (the “General Principles”), which will apply to any transaction
regulated by the Irish Takeover Panel:
a)
in the event of an offer, all holders of securities of the target company should be afforded equivalent treatment and, if a person
acquires control of a company, the other holders of securities must be protected;
b)
the holders of the securities of the target company must have sufficient time and information to enable them to reach a properly
informed decision on the offer; where it advises the holders of securities, the board of the target company must give its views on the
effects of implementation of the offer on employment, conditions of employment and the locations of the target company’s places
of business;
c)
the board of the target company must act in the interests of the company as a whole and must not deny the holders of securities the
opportunity to decide on the merits of the offer;
d)
false markets must not be created in the securities of the target company, the bidder or of any other company concerned by the offer
in such a way that the rise or fall of the prices of the securities becomes artificial and the normal functioning of the markets is
distorted;
e)
a bidder must announce an offer only after ensuring that it can fulfill in full, any cash consideration if such is offered, and after
taking all reasonable measures to secure the implementation of any other type of consideration;
f)
a target company must not be hindered in the conduct of its affairs for longer than is reasonable by an offer for its securities; and
g)
a substantial acquisition of securities (whether such acquisition is to be effected by one transaction or a series of transactions) shall
take place only at an acceptable speed and shall be subject to adequate and timely disclosure.
Mandatory Bid
Under certain circumstances, a person who acquires our shares may be required under the Irish Takeover Rules to make a mandatory
cash offer for our remaining outstanding shares at a price not less than the highest price paid for the shares by that acquirer (or any parties
acting in concert with the acquirer) during the previous twelve months. This mandatory bid requirement is triggered if an acquisition of
shares would increase the aggregate holding of an acquirer (including the holdings of any parties acting in concert with the acquirer) to shares
representing 30% or more of our voting rights, unless the Irish Takeover Panel otherwise consents. An acquisition of shares by a person
holding (together with its concert parties) shares representing between 30% and 50% of our voting rights would also trigger the mandatory
bid requirement if, after giving effect to the acquisition, the percentage of the voting rights held by that person (together with its concert
parties) would increase by 0.05% within a twelve-month period. Any person (excluding any parties acting in concert with the holder) holding
shares representing more than 50% of the voting rights of a company is not subject to these mandatory offer requirements.
Voluntary Bid; Requirements to Make a Cash Offer and Minimum Price Requirements
If a person makes a voluntary offer to acquire our outstanding ordinary shares, the offer price must be no less than the highest price
paid for our ordinary shares by the bidder or its concert parties during the three-month period prior to the commencement of the offer period.
The Irish Takeover Panel has the power to extend the “look back” period to twelve months if the Irish Takeover Panel, taking into account
the General Principles, believes it is appropriate to do so.
If the bidder or any of its concert parties has acquired our ordinary shares: (i) during the period of twelve months prior to the
commencement of the offer period which represent more than 10% of our total ordinary shares; or (ii) at any time after the commencement of
the offer period, the offer must be in cash (or accompanied by a full cash alternative) and the price per ordinary share must not be less than
the highest price paid by the bidder or its concert parties during, in the case of (i), the 12-month period prior to the commencement of the
offer period and, in the case of (ii), the offer period. The Irish Takeover Panel may apply this rule to a bidder who, together with its concert
parties, has acquired less than 10% of our total ordinary shares in the 12-month period prior to the commencement of the offer period if the
Irish Takeover Panel, taking into account the General Principles, considers it just and proper to do so.
An offer period will generally commence from the date of the first announcement of the offer or proposed offer.
Any announcement by us which commences an offer period must identify the potential bidder with which we are in talks or from
which an approach was received. Any such bidder will then have a period of 42 days following such announcement (i.e. the announcement in
which they are first identified) to announce a firm intention to make an offer or announce that they do not intend to do so, in which case they
will then be restricted from making an offer for six months.
Substantial Acquisition Rules
The Irish Takeover Rules also contain rules governing substantial acquisitions of shares which restrict the speed at which a person may
increase his or her holding of shares and rights over shares to an aggregate of between 15% and 30% of our voting rights. Except in certain
circumstances, an acquisition or series of acquisitions of shares or rights over shares representing 10% or more of our voting rights is
prohibited, if such acquisition(s), when aggregated with shares or rights already held, would result in the acquirer holding 15% or more but
less than 30% of our voting rights and such acquisitions are made within a period of seven days. These rules also require accelerated
disclosure of acquisitions of shares or rights over shares relating to such holdings.
Shareholder Rights Plan
Under our Constitution, our Board is authorized to adopt a shareholder rights plan (a “Shareholder Rights Plan”), upon such terms and
conditions as the Board deems expedient and in the best interests of the Company, subject to applicable law, including the grant of rights
(including approving the execution of any documents relating to the grant of such rights) to subscribe for ordinary shares or preferred shares
in the share capital of the Company in accordance with the terms of any Shareholder Rights Plan. The Board or any duly appointed
committee thereof may effect an exchange of rights in accordance with such Shareholder Rights Plan.
Frustrating Action
Under the Irish Takeover Rules, our Board is not permitted to take any action which might frustrate an offer for our shares once the
Board has received an approach which may lead to an offer or has reason to believe an offer is or may be imminent, subject to certain
exceptions. Potentially frustrating actions such as: (i) the issue of shares, options or convertible securities; (ii) material acquisitions or
disposals; (iii) entering into contracts other than in the ordinary course of business; or (iv) any action, other than seeking alternative offers,
which may result in frustration of an offer, are prohibited during the course of an offer or at any time during which the Board has reason to
believe an offer is imminent. Exceptions to this prohibition are available where:
a)
the action is approved by our shareholders at a general meeting; or
b)
the Irish Takeover Panel has given its consent, where:
1.
it is satisfied the action would not constitute frustrating action;
2.
the holders of 50% of the voting rights state in writing that they approve the proposed action and would vote in favor of it
at a general meeting;
3.
the action is taken in accordance with a contract entered into prior to the announcement of the offer; or
4.
the decision to take such action was made before the announcement of the offer and either has been at least partially
implemented or is in the ordinary course of business.
Certain other provisions of Irish law or our Constitution may be considered to have anti-takeover effects, including those described
under the following captions: “—Authorized Share Capital” (regarding issuance of preferred shares), “—Pre-emption Rights, Share
Warrants and Share Options,” “—Disclosure of Interests in Shares,” and “—Corporate Governance.”
Appointment of Directors of the Board
At each annual general meeting of shareholders, each director who is nominated for election or re-election at that annual general
meeting of shareholders shall be eligible for election for a one-year term. Except as otherwise set forth in our Constitution, directors will be
elected by way of ordinary resolution at a general meeting. In the event of a contested election (where the number of persons validly
nominated for election exceeds the number of available director positions to be elected), only those directors in number equal to the number
of available director positions and who receive the highest number of votes in favor of their election shall be elected. In no case will a
decrease in the size of the Board shorten the term of any incumbent director. A director shall hold office until the close of the annual general
meeting of shareholders for the year in which their term expires and until their successor shall be elected and shall qualify, subject, however,
to prior death, resignation, retirement, disqualification or removal from office. Any vacancy on the Board, including a vacancy that results
from an increase in the size of the Board or from the death, resignation, retirement, disqualification or removal of a director, shall be deemed
a casual vacancy, and subject to the terms of any one or more classes or series of preferred shares (if any), shall only be filled by decision of a
majority of the Board then in office. Any director appointed to fill a vacancy shall hold office until the next annual general meeting. A
director retiring from the Board at a general meeting shall retain office until the close or adjournment of such meeting.
During any vacancy in the Board, the remaining directors have full power to act as the Board. If, at any general meeting of the
Company (other than in the event of a contested election), the number of directors is reduced below the minimum prescribed by the Board
due to the failure of any persons nominated to be directors to be elected, then in those circumstances, the nominee or nominees who receive
the highest number of votes in favor of election shall be elected in order to maintain the prescribed minimum number of directors and each
such director shall remain a director (subject to the provisions of the Companies Act and our Constitution) only until the conclusion of the
next annual general meeting of the Company unless such director is re-elected by the our shareholders during such meeting.
Duration; Dissolution; Rights upon Liquidation
Our duration is unlimited. We may be dissolved and wound up at any time by way of a shareholders’ voluntary winding up or a
creditors’ winding up. In the case of a shareholders’ voluntary winding-up, a special resolution of shareholders is required. We may also be
dissolved by way of court order on the application of a creditor, or by the Companies Registration Office as an enforcement measure where
we have failed to file certain returns.
The rights of the shareholders to a return of our assets on dissolution or winding up, following the settlement of all claims of creditors,
may be prescribed in our Constitution or the terms of any preferred shares issued by our Board from time to time. The holders of preferred
shares in particular may have the right to priority in our dissolution or winding up. If the Constitution contains no specific provisions in
respect of a dissolution or winding up then, subject to the priorities of any creditors, the assets will be distributed to shareholders in
proportion to the paid-up nominal value of the shares held. Our Constitution provides that our ordinary shareholders are entitled to participate
pro rata in a winding up, but their right to do so may be subject to the rights of any preferred shareholders to participate under the terms of
any series or class of preferred shares.
Uncertificated Shares
Pursuant to the Companies Act, a shareholder is entitled to be issued a share certificate on request and subject to payment of a nominal
fee.
No Sinking Fund
Our ordinary shares have no sinking fund provisions.
No Liability for Further Calls or Assessments
Our ordinary shares are duly and validly issued and fully-paid.
Transfer and Registration of Shares
Our transfer agent maintains our share register, which is determinative of ownership of our shares. Our shareholders who hold shares
beneficially are not the holders of record of such shares. Instead, the depository (for example, Cede & Co., as nominee for DTC) or other
nominee is the holder of record of those shares. Accordingly, a transfer of shares from a person who holds such shares beneficially to a
person who also holds such shares beneficially through a depository or other nominee will not be registered in our official share register, as
the depository or other nominee will remain the record holder of any such shares.
A written instrument of transfer is required under Irish law in order to register on our official share register any transfer of shares: (i)
from a person who holds such shares directly to any other person; (ii) from a person who holds such shares beneficially to a person who
holds such shares directly; or (iii) from a person who holds such shares beneficially to another person who holds such shares beneficially
where the transfer involves a change in the depository or other nominee that is the record owner of the transferred shares. An instrument of
transfer is also required for a shareholder who directly holds shares to transfer those shares into his or her own broker account (or vice versa).
Such instruments of transfer may give rise to Irish stamp duty, which must be paid prior to registration of the transfer on our official Irish
share register. However, a shareholder who directly holds shares may transfer those shares into his or her own broker account (or vice versa)
without giving rise to Irish stamp duty provided there is no change in the ultimate beneficial ownership of the shares as a result of the transfer
and the transfer is not made in contemplation of a sale of the shares.
Any transfer of our ordinary shares that is subject to Irish stamp duty will not be registered in the name of the buyer unless an
instrument of transfer is duly stamped and provided to the transfer agent. Our Constitution allows us, in our absolute discretion, to create an
instrument of transfer and pay (or procure the payment of) any stamp duty, which is the legal obligation of a buyer. In the event of any such
payment, we are (on our behalf or on behalf of our affiliates) entitled to: (i) seek reimbursement from the buyer or seller (at our discretion);
(ii) set-off the amount of the stamp duty against future dividends payable to the buyer or seller (at our discretion); and (iii) claim a lien
against the ordinary shares on which we have paid stamp duty. Parties to a share transfer may assume that any stamp duty arising in respect
of a transaction in our ordinary shares has been paid unless one or both of such parties is otherwise notified by us.
Our Constitution delegates to our secretary the authority to execute an instrument of transfer on behalf of a transferring party.
In order to help ensure that the official share register is regularly updated to reflect trading of our ordinary shares occurring through
normal electronic systems, we intend to regularly produce any required instruments of transfer in connection with any transactions for which
we pay stamp duty (subject to the reimbursement and set-off rights described above). In the event that we notify one or both of the parties to
a share transfer that we believe stamp duty is required to be paid in connection with the transfer and that we will not pay the stamp duty, the
parties may either themselves arrange for the execution of the required instrument of transfer (and may request a form of instrument of
transfer from us for this purpose) or request that we execute an instrument of transfer on behalf of the transferring party in a form
determined by us. In either event, if the parties to the share transfer have the instrument of transfer duly stamped (to the extent required) and
then provide it to our transfer agent, the buyer will be registered as the legal owner of the relevant shares on our official Irish share register
(subject to the matters described below).
The Board may suspend registration of transfers from time to time, with such suspensions not to exceed 30 days in aggregate each
year.
Exhibit 19.1
ACTIVE/136096699.2
ALKERMES plc
INSIDER TRADING POLICY
In the normal course of business, officers, directors, employees (including contract employees) and independent contractors of Alkermes
plc and its subsidiaries (the “Company”) may come into possession of material, nonpublic information about the Company, its business or
other companies with which the Company interacts. This information is legally considered the property of the Company. If you are in
possession of any such information, you may not seek to benefit from it by transacting in any such securities yourself, or passing on the
information to others to enable them to benefit.
It is also the policy of the Company to transact in Company securities in compliance with all applicable securities laws and regulations.
The misuse of material, nonpublic information is contrary to Company policy and U.S. securities laws and may lead to severe
consequences. The purpose of this Insider Trading Policy (this “Policy”) is to inform you of your legal responsibilities in this area.
What is Insider Trading?
Insider trading, which entails transacting in a security with knowledge of material, nonpublic information about that security or the issuer of
that security, is a crime that may be penalized by civil fines of reimbursement of amounts unduly received from such trading and punitive
payments of up to three times the profit gained or loss avoided by such trading, as well as criminal fines of up to $5,000,000 (USD) and up
to 20 years in jail for individuals. Under some circumstances, individuals convicted of insider trading may be subjected to civil liability in
private lawsuits.
In addition to these consequences to the person engaging in insider trading, employers and other controlling persons (including supervisory
personnel) are at risk under federal law for the actions of their employees. Controlling persons may, among other things, face major
criminal and/or civil penalties if they recklessly fail to take preventive steps to control insider trading. Even if the Company is not
prosecuted, the fact that a director, officer, employee or contractor of the Company was under investigation or prosecuted for insider
trading could severely damage the reputation of the Company.
Thus, it is important both to you and the Company to prevent the occurrence of insider trading violations. You should be aware that stock
market surveillance techniques designed to identify potential insider trading transactions have become extremely sophisticated and are
being improved all the time. Insider trading cases have been successfully prosecuted against employees based on their trading through
foreign accounts, trading by their family members and friends, and trading only involving a small number of shares. The chance that federal
authorities or exchange regulators will detect even small-level trading is significant.
The Insider Trading Laws
As an officer, director, employee (including contract employee) or independent contractor of the Company, you may not seek to benefit
personally by transacting in securities while in possession of material, nonpublic information. This rule applies to transacting, or your
directing others to transact, in the Company’s securities (whether ordinary shares, preferred shares, convertible securities, stock options or
any other derivative securities that provide the economic equivalent of ownership of any of the Company’s securities or an opportunity,
direct or indirect, to benefit from any change in the value of the Company’s securities) and in the securities of other companies if you learn
something in the course of your employment or relationship with the Company that might affect the value of any such other company.
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For instance, if you learned that the Company was about to acquire ABC Corporation prior to a public announcement, it would almost
certainly be an insider trading violation for you to transact in ABC securities as well as the Company’s securities. If you learned something
about XYZ Corporation which was not publicly known while you were working for us on a collaboration with XYZ, transacting in XYZ
securities might well be considered illegal, even if the information learned was not related to the collaboration. The insider trading rules
apply to purchases, sales and gifts of securities. Sometimes material nonpublic information about the Company or another company with
which the Company is working comes to your attention even though you are not directly involved in the project. You are nonetheless
prohibited from transacting in the Company’s securities or the securities of such other company.
What is “Material” Information?
“Material” information is information that a typical investor would likely consider significant. There is no fixed quantitative threshold
amount for determining materiality; even very small quantitative changes can be qualitatively material if they would result in a movement
in the price of the Company’s ordinary shares. If you learn something that leads you to want to buy, sell or gift securities, that information
could be considered material. Both positive and negative information may be material. It is important to keep in mind that material
information need not be definitive information; information that something is likely to happen, or even just that it may happen, can be
considered material. Examples of information that could be potentially material include changes in Company management, threatened
litigation, Company or product performance above or below issued financial guidance, the Company’s involvement in merger or licensing
negotiations (even if the deal had not yet been agreed to), or the success of a feasibility or clinical study for a development compound. Keep
in mind that the U.S. Securities and Exchange Commission (the “SEC”) takes the view that the mere fact that you are in possession of the
material, nonpublic information is enough to bar you from trading. Therefore, trading while in possession of material, nonpublic
information or tipping this information to others to trade, even if such trades were not based on such information, is violative of this Policy
and the law. If you have questions as to whether information in your possession may be deemed “material”, you may seek guidance from
the Chief Financial Officer or the Chief Legal Officer to assist in that determination. It is important, however, that you bear in mind that the
ultimate responsibility for determining whether you are in possession of material, nonpublic information belongs to you, and that any
advice or action on the part of the Company, the Chief Financial Officer, the Chief Legal Officer or any other employee or director pursuant
to this Policy (or otherwise) does not in any way constitute legal advice or insulate you from liability under applicable U.S. securities laws.
What is “Nonpublic” Information?
“Nonpublic” information is any information that is not reasonably accessible to the investing public. To show that information is public, it is
necessary to point to some fact that establishes that the information has become publicly available, such as the filing of a report with the SEC,
the distribution of a press release through a widely disseminated news or wire service, or by other means that are reasonably designed to
provide broad public access. Before a person who possesses material, nonpublic information can trade, there must also be adequate time for
the market as a whole to absorb the information that has been disclosed. Once the Company releases information through public channels (for
instance, in a press release or an SEC filing), it may take up to 48 hours for it to be considered broadly disseminated. For purposes of this
Policy, information will be considered public after the close of trading on the second full trading day following the Company’s public release
of the information.
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Policy
Prohibited Use of Material, Nonpublic Information
When you are in possession of material, nonpublic information about the Company, or about any other company if such information is
gained in the course of your employment or other relationship with us, or when you are in a “blackout period” (as described below), you are
prohibited from engaging in any activity that would be considered unlawful trading or tipping under the U.S. securities laws, whether in the
Company’s securities or the securities of another company. These prohibitions extend to your family members living in the same home as
you, family members who do not live in the same home as you but whose transactions are directed by you or subject to your influence or
control and to any investment fund, trust, retirement plan, partnership, corporation or other entity over which you have the ability to
influence or direct investment decisions concerning securities, and continues whenever and for as long as you know or are in possession of
material, nonpublic information or the blackout period is in place. You are responsible for ensuring compliance with this Policy by all such
persons affiliated with you. The SEC and federal prosecutors may presume that trading by your family members (including those that do
not live in the same home as you) and friends is based on information you supplied and may treat any such transactions as if you had traded.
There is no exception for small transactions or transactions that may seem necessary or justifiable for personal financial emergency or
hardship.
Tipping Information to Others
Besides your obligation to refrain from trading or having others trade on your behalf while you are in possession of material, nonpublic
information, you are also prohibited from “tipping” others. The concept of unlawful tipping includes passing on material, nonpublic
information to friends, family members or others under circumstances that suggest that you were trying to help them make a profit or avoid a
loss or enjoy some other benefit. When tipping occurs, both the “tipper” and the “tippee” may be held liable, and this liability may extend to
all those to whom the tippee gives information. Besides being considered a form of insider trading, tipping is also a serious breach of
corporate confidentiality. You should be careful to avoid discussing confidential information in any place (for instance, at lunch, on public
transportation, on a cell phone in a public place, in elevators, etc.) where such information may be overheard or intercepted by others. You
should exercise care when discussing any material, nonpublic information with other members of the Company who do not have a “need to
know” such information, even though they are also subject to this Policy, so as to reduce the possibility of leaks.
Transacting in Company Securities
If you want to buy, sell, gift (which term, as used in this Policy, includes charitable donations) or otherwise transact in any Company
securities, you must first determine if you are in possession of material, nonpublic information. If so, you may not buy, sell, gift or otherwise
transact in, or provide such information to others to transact in, any Company securities, no matter what position you hold with the Company.
This includes the exercise of stock options using cash from the sale of shares to pay the exercise price (also known as a “cashless exercise”),
and bona fide gifts of Company securities. If you are not sure whether or not you are in possession of material, nonpublic information, you
should not buy, sell, gift or otherwise transact in, or tip others to transact in, any Company securities.
From time to time, the Chief Financial Officer or Chief Legal Officer may determine that certain persons within the Company or everyone
within the Company may not buy, sell, gift or otherwise transact in Company securities, also known as a “blackout period.” You will be
notified when a blackout period is in place. A determination by the Chief Financial Officer or Chief Legal Officer that no purchases, sales or
other transactions may be made is itself deemed to be material, nonpublic information that should not be discussed outside the Company.
4
Since financial information about the Company can significantly affect trading in the Company’s securities, all officers, directors, employees
(including contract employees) and independent contractors are subject to a blackout period beginning at the end of the 15th day of the final
month of each fiscal quarter, and ending after the close of trading on the second full trading day following the Company’s public release of
its quarterly or annual financial results or other financial information (the “Quarterly Blackout Period”). You may not buy, sell, gift or
otherwise transact in, or tip others to transact in, any Company securities or enter into a planned sales program for transactions in Company
securities during any Quarterly Blackout Period.
The Company may also issue material information to the public at other times, which may result in additional blackout periods outside of the
Quarterly Blackout Periods. In such circumstances, you will be notified of the applicable blackout period.
Please note that stock options issued by the Company have an expiration date. It is your responsibility to track the expiration date of any
stock options which you may have been granted and to plan accordingly if you wish to exercise such options via a cashless exercise.
Transacting in Securities of Other Companies
As previously discussed in this Policy, if you want to transact in any securities (including, without limitation, common or ordinary shares,
preferred shares, convertible securities, or warrants) of a company that is a corporate partner, a collaborator or a possible acquisition target,
or any other company about which you’ve received information in the course of your employment with us, you must first determine whether
you are in possession of any nonpublic information related to such company and whether that information is material to that company. If you
are not sure whether you are in possession of material, nonpublic information, you should not buy, sell, gift or otherwise transact in, or tip
others to transact in, any securities of such other company.
Post-Termination Transactions
This Policy continues to apply even after termination of your employment or other service relationship with the Company. If an individual is
in possession of material, nonpublic information received in the course of their employment or other service relationship with us, when their
employment or other service relationship terminates, that individual may not trade in the securities of the company to which such information
relates until that information has become public or is no longer material.
Additional Prohibited Transactions
Officers, directors, employees (including contract employees) and independent contractors are prohibited from engaging in speculative
transactions in the Company’s securities, including by way of the purchase or sale of “put” or “call” options or other derivative securities
directly linked to the Company’s equity; short sales of the Company’s equity; the use of Company securities as a pledge or as collateral in a
margin account; and trading in straddles, equity swaps, or other hedging transactions directly linked to Company securities, even if such
persons do not possess material, nonpublic information.
Preclearance
To provide assistance in preventing inadvertent insider trading violations and avoiding the appearance of an improper transaction (which
could result, for example, when an employee engages in a trade while unaware of a pending major Company development) and for purposes
of compliance with the reporting and other disclosure requirements relating to insider transactions, the Company has implemented the
following preclearance policy:
•
Members of the Alkermes plc board of directors, management committee and disclosure committee, “officers” of the Company
(as such term is defined in Section 16a-1(f) of the
5
Securities Exchange Act of 1934, as amended (the “Exchange Act”), and each such officer, a “Section 16 Reporting Officer”),
Company employees in a position of vice president (or equivalent) or higher, Company employees in the finance, business
development, alliance management, business planning, corporate affairs, investor relations, legal, and certain employees
designated by management in the research and development, commercial and information technology organizations, must obtain
preclearance from the Chief Financial Officer or Chief Legal Officer before they may transact in Company securities, which, for
the avoidance of doubt, also includes gifting Company securities (whether directly or through a donor advised fund), even if no
blackout period is in effect such that the “window” for trading in Company securities is then open and transactions in Company
securities would otherwise be allowed under this Policy.
•
Additionally, from time to time, certain additional individuals may be exposed to material, nonpublic information because of
their job or other relationship with the Company and shall be required to seek preclearance from the Chief Financial Officer or
Chief Legal Officer before transacting in any Company securities.
•
A list of individuals requiring preclearance by the Chief Financial Officer or Chief Legal Officer will be periodically generated
by the legal department of the Company and communicated to the employees on the list (the “Preclearance List”).
Be advised that preclearance from the Chief Financial Officer or Chief Legal Officer does not constitute legal advice, does not constitute
confirmation that you do not possess material, nonpublic information and does not relieve you of your obligations under the U.S. securities
laws; it is a safeguard that the Company has put in place to help protect you and the Company.
If you are an individual who requires preclearance and you are contemplating a transaction in the Company’s securities, you should contact
the legal department at least two business days in advance. You can send your preclearance request to preclearancerequest@alkermes.com.
You are responsible for ensuring that you do not have material, nonpublic information about the Company, or about other companies if you
learn something in the course of your employment or relationship with the Company that might affect the value of any such other company,
before engaging in a transaction involving such company’s securities and that you comply with any and all other legal obligations.
Therefore, before you make a request for preclearance, you should carefully consider whether you are aware of any material, nonpublic
information and should describe fully any relevant circumstances in your preclearance request. The Chief Financial Officer or Chief Legal
Officer is under no obligation to approve any trade submitted for preclearance.
If you are precleared to trade, your transaction must be executed within 48 hours after receiving preclearance approval but, even if so
precleared, may not be executed if you acquire material, nonpublic information after preclearance approval and before executing the trade.
If the transaction does not take place during that time, you must re-request preclearance through the same process.
Special Types of Permitted Transactions
C ash Exercises of Stock Options
This Policy does not apply to an exercise of stock options when payment of the exercise price is made entirely in cash. However, this
Policy does apply to any shares acquired through an option exercise made entirely in cash, and you may not sell any of those acquired
shares for so long as you are in possession of material, nonpublic information. This Policy also applies to the use of Company shares to
constitute part, or all, of the exercise price of a stock option (referred to as a “cashless exercise” of a
6
stock option), or any other market sale for the purpose of generating the cash needed to pay the exercise price of a stock option. No matter
how you exercise or otherwise acquire Company securities, during your employment with the Company, you may only sell Company
securities, including those obtained through a stock option exercise, at the times outlined in this Policy.
Restricted Stock Unit Awards (“RSUs”)
This Policy does not apply to the vesting of RSUs, or to the Company’s withholding of shares upon vesting of RSUs to satisfy tax
withholding requirements.
Planned Sales Programs under Rule 10b5-1
Entry into a trading plan, arrangement or instruction that meets the requirements of Rule 10b5-1 of the Exchange Act (a “Rule 10b5-1 Plan”
or a “Plan”) enables you to trade in Company securities outside of our open trading windows, even when in possession of material,
nonpublic information.
If you are a member of the Alkermes plc board of directors, management committee or disclosure committee, a Section 16 Reporting
Officer, or a member of one of the functions listed above that are subject to preclearance, the Company strongly encourages you to transact
in the Company’s securities under a Rule 10b5-1 Plan. In addition, if you routinely have access to material, nonpublic information as part
of your responsibilities with the Company, you may find a Rule 10b5-1 Plan to be useful as well.
Members of the Alkermes plc board of directors and Section 16 Reporting Officers should also be mindful of their respective share
ownership and/or holding requirements under the Alkermes plc Amended and Restated Share Ownership and Holding Guidelines when
considering establishing a Rule 10b5-1 Plan or any other transaction in the Company’s securities.
If you intend to trade pursuant to a Rule 10b5-1 Plan, such plan, arrangement or instruction must:
•
satisfy the requirements of Rule 10b5-1;
•
be documented in writing and include a written representation by you that you are not aware of any material nonpublic
information concerning the Company and that you are adopting the Plan in good faith and not as part of a plan or scheme to
evade the prohibitions of Section 10(b) and Rule 10b-5 of the Exchange Act;
•
be established during an open trading window (in accordance with this Policy) and at a time when you do not possess material,
nonpublic information about the Company; and
•
be pre-approved by the Chief Financial Officer or the Chief Legal Officer.
In order to satisfy Rule 10b5-1, all Rule 10b5-1 Plans are subject to a mandatory cooling off period (consisting of at least 30 days or more
under certain circumstances for employees other than Section 16 Reporting Officers and at least 90 days or more under certain
circumstances for Section 16 Reporting Officers and members of the Alkermes plc board of directors) prior to the date of the first planned
sale or other transaction under such Plan. All Rule 10b5-1 Plans must also adhere to certain prescribed limitations on the number and nature
of Plans that may be in effect at a given time (e.g., minimum number of trades requirement, term limitations) and such other Plan
parameters as the Chief Financial Officer or the Chief Legal Officer deems to be in the best interests of the Company.
Modifications to, or terminations of, Rule 10b5-1 Plans are highly discouraged and require the approval of the Chief Financial Officer or
the Chief Legal Officer. If you are a director or a Section 16 Reporting Officer, the Company will be required to disclose any adoption,
modification or termination of a 10b5-1 Plan by you and certain details relating to such Plan in its periodic reports filed with the SEC. Any
questions in respect of a Rule 10b5-1 Plan, requests for approval of entry into, modification or termination of a Rule 10b5-1 Plan or the
required disclosure relating to such Plans, should be submitted
7
to preclearancerequest@alkermes.com.
Transactions effected pursuant to a pre-approved and executed Rule 10b5-1 Plan will not be subject to the Company’s blackout periods or
other preclearance procedures.
Investing in Mutual Funds
You may invest in any mutual fund which invests in the Company’s securities or the securities of any company with which the Company
has a relationship without regard to this Policy.
Reports of purchases, sales and gifts for Board members and Section 16 Reporting Officers
If you are a member of the Alkermes plc board of directors or a Section 16 Reporting Officer, keep in mind the various restrictions on
securities transactions imposed under Section 16 of the Exchange Act and the corresponding reporting requirements. You must immediately
report to the Chief Financial Officer or the Chief Legal Officer or their designees all transactions made in the Company’s securities by you,
any family member, and any trusts or entities that you control, including gifts and cash exercises of stock options. The Company requires
same-day reporting to it of any such transaction due to SEC requirements that certain insider reports be filed with the SEC by the second
day after the date on which a reportable transaction occurs. In addition, you must comply with the preclearance procedures set forth above
in respect of any such transactions.
Disclosure of Confidential Information
The confidentiality of all material, nonpublic information that you learn while working at the Company (whether or not such information is
about the Company) must be strictly maintained within the Company. Only certain executive officers and certain members of the Corporate
Affairs and Investor Relations departments are authorized to disclose material, nonpublic information about the Company to the public,
members of the investment community (including analysts), or to shareholders, unless one of these executive officers expressly authorizes
disclosure by another employee in advance.
In addition, with advances in electronic communications and the corresponding increased use of the Internet, email communications, social
networking sites, video sharing websites, electronic bulletin boards, chat rooms and blogs, electronic discussions about companies and their
business prospects (collectively, “Electronic and Social Media”) have become common. Inappropriate communications disseminated on the
Internet may pose an inherently greater risk due to the size of the audience they can reach. It is important for Company employees who
choose to participate in Electronic and Social Media to understand what is recommended, expected and required when discussing
Company-related topics. In this context, you are prohibited from sharing any nonpublic information about the Company and from
discussing revenues, future plans, prospects, products or the share price of the Company in any comments, responses, or postings on any
Electronic and Social Media and are subject in all respects to the Company’s social media policy, available on the Company’s internal
intranet.
You should not, under any circumstances, recommend or express opinions as to the Company’s securities or comment on rumors or
predictions about the Company, regardless of whether the rumor is false and whether you think your recommendation, opinion or comment
is being made on an anonymous basis (for example, in any Electronic and Social Media). If you are ever asked a direct question about the
Company or any prevailing rumor about the Company, you should respond that it is Company policy not to comment on such matters and
that any questions should be directed to the Company’s Investor Relations department or Chief Financial Officer. This Policy operates in
addition to any other Company policies relating to safeguarding the confidentiality of the Company’s internal, proprietary information.
Reporting of Violations
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If you violate this Policy or any federal or state laws governing insider trading, or know of any such violation by any director, officer,
employee, or independent contractor of the Company, you must report the violation immediately to your supervisor, or to the Chief
Financial Officer or the Chief Legal Officer of the Company. Persons violating this Policy will be subject to disciplinary action by the
Company, up to and including termination.
Modifications
The Company may at any time change this Policy or adopt such other policies or procedures which it considers appropriate to carry out the
purposes of this Policy. A current copy of this Policy is maintained on the Corporate Governance section of the Investors tab of the
Company’s website.
Questions
You are encouraged to ask questions and seek any follow-up information that you may require with respect to the matters set forth in this
Policy. Please direct all questions to preclearancerequest@alkermes.com.
* * *
Your failure to observe this Policy could lead to significant legal and other consequences, including the potential termination of your
employment.
Exhibit 21.1
SUBSIDIARIES
Name
Jurisdiction
Alkermes Ireland Holdings Limited
Ireland
Alkermes Pharma Ireland Limited
Ireland
Daravita Pharma Ireland Limited
Ireland
Alkermes Finance Ireland (No 3) Limited
Ireland
Alkermes Science Four Limited
Ireland
Alkermes Science Five Limited
Ireland
Alkermes US Holdings, Inc.
Delaware
Alkermes, Inc.
Pennsylvania
Alkermes Controlled Therapeutics, Inc.
Pennsylvania
Rodin Therapeutics, Inc.
Delaware
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S‑8 (Nos. 333-179545, 333-184621, 333-200777,
333-214952, 333-226359, 333-232831, 333-240170, 333-258229, 333-266350, 333-273456 and 333-280984) of Alkermes plc of our report dated February
12, 2025 relating to the financial statements and the effectiveness of internal control over financial reporting, which appears in this Form 10‑K.
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
February 12, 2025
Exhibit 31.1
CERTIFICATIONS
I, Richard F. Pops, certify that:
1.
I have reviewed this annual report on Form 10-K of Alkermes plc;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered
by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined
in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and
15d-15(f)) for the registrant and have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us
by others within those entities, particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, 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;
c.
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most
recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably
likely to materially affect, the registrant's internal control over financial reporting; and
5.
The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting,
to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's
internal control over financial reporting.
Date: February 12, 2025
/s/ Richard F. Pops
Richard F. Pops
Chairman and Chief Executive Officer
(Principal Executive Officer)
Exhibit 31.2
CERTIFICATIONS
I, Blair C. Jackson, certify that:
1.
I have reviewed this annual report on Form 10-K of Alkermes plc;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-
15(f)) for the registrant and have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us
by others within those entities, particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, 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;
c.
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most
recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably
likely to materially affect, the registrant's internal control over financial reporting; and
5.
The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting,
to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's
internal control over financial reporting.
Date: February 12, 2025
/s/ Blair C. Jackson
Blair C. Jackson
Executive Vice President, Chief Operating Officer
(Interim Principal Financial Officer)
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report on Form 10-K of Alkermes plc (the "Company") for the period ended December 31, 2024 as filed with the
Securities and Exchange Commission on the date hereof (the "Report"), we, Richard F. Pops, Chairman and Chief Executive Officer of the Company, and
Blair C. Jackson, Executive Vice President, Chief Operating Officer and Interim Principal Financial Officer of the Company, certify, pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to our knowledge:
(1)
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: February 12, 2025
/s/ Richard F. Pops
Richard F. Pops
Chairman and Chief Executive Officer
(Principal Executive Officer)
Date: February 12, 2025
/s/ Blair C. Jackson
Blair C. Jackson
Executive Vice President, Chief Operating Officer
(Interim Principal Financial Officer)