What changed in this filing

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Item 1A. Risk Factors

2026-02-25 compared with 2025-02-12 · 185 added, 83 removed, 562 unchanged (32% of the section changed)

7 unchanged sentences

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.

We exclusively commercialize these products, and LUMRYZ for the treatment of cataplexy or EDS in patients seven years and older with narcolepsy, in the U.S.

Our success depends in large part on our ability to continue to successfully manufacture and/or 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.

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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;

• the cost-effectiveness of our products and reimbursement policies of government and third-party payers that may impact use of our products;

• our ability to obtain and/or maintain regulatory exclusivities, including orphan drug exclusivity for LUMRYZ;

• with respect to LUMRYZ, our ability and the ability of our certified pharmacies, physicians and patients to meet the requirements under the REMS, and physician and patient perception and assessment of the burdens associated with obtaining LUMRYZ in compliance with the REMS;

• 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;

• our ability to engage third parties to manufacture, package and/or distribute our products on acceptable terms, or at all;

• the size of the markets for our products, and patient and physician satisfaction with our products;

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• 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;

• regulatory developments and actions related to the manufacture, commercialization or continued use of our products, including FDA actions such as the issuance or modification of a REMS or issuance of an untitled or warning letter, or conduct of an audit by the FDA, the DEA, 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;

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• exchange rate valuations and fluctuations;

• issuance and/or implementation of rules by CMS or other federal agencies that lessen the net revenue we receive on the sale of our products or that serve to alter the prices of competitors’ products with which we compete;

• the impact of participation in the MDRP and 340B programs on the sales of our products, including the net revenue received from such sales;

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;

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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;

changes in, and implementation of, federal or state government regulations, legislation 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

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.

and consolidation and increasing assertiveness of payors and pharmacy benefit managers (“PBMs”) seeking price discounts or 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.

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 imposed 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 negotiated prices for the first ten Part D drugs took effect January 1, 2026.

CMS has also identified an additional fifteen Part D drugs for negotiation for 2027, including VRAYLAR, an oral antipsychotic that competes with LYBALVI and ARISTADA.

We cannot predict how the negotiated price for products in Medicare Part D, including VRAYLAR, may ultimately affect our products.

In addition, the Drug Price Negotiation Program is subject to ongoing litigation, the outcome of which is difficult to predict.

Additionally, the OBBBA, which was enacted in July 2025, imposes significant reductions in the funding of the Medicaid program and the enhanced PPACA subsidies expired as of December 31, 2025.

Such reductions and loss of subsidies are expected to decrease the number of individuals enrolled in Medicaid over time and reduce the services covered by Medicaid, which could adversely affect our business, financial condition, cash flows and results of operations.

We also face uncertainties related to the government’s MFN pricing initiatives, including the GLOBE, GUARD, and GENEROUS models described above, which are intended to reduce Medicare and Medicaid drug expenditures by tying U.S.

prices to those paid in certain other developed countries.

Given the complexity of these models and the likelihood of legal or operational challenges, the potential impact on our business 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.

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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.

Any 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).

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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.

Our patient 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.

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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.

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

We completed the Avadel Acquisition successfully in February 2026.

We are in the process of integrating Avadel’s business into ours, including integration of a number of complex operational and administrative systems, to form a unified combined company, including with respect to human resources, intellectual property management, research and development activities, finance, accounting and internal control processes and systems, sales operations, product distribution, commercialization efforts, government price reporting, information and information security systems, compliance programs and policies and supply chain systems and third party relationships (including vendors and third party manufacturers).

While our teams are working to ensure an effective and efficient integration, our and Avadel’s businesses may not be effectively integrated and the anticipated operational, financial, strategic and other benefits and synergies of the acquisition may not be achieved.

These anticipated benefits and synergies are based on a number of assumptions and uncertainties, which may prove to be incorrect or incomplete.

If we are not able to successfully integrate our and Avadel’s operations, difficulties may arise relating to employee morale, such as the potential loss of key employees that may be difficult to replace, diversion of management’s attention from operation of the business, failure to harmonize both companies’ corporate cultures, any disruption to each company’s ongoing businesses or inconsistencies in standards, controls, procedures and policies that may adversely affect our ability to maintain third-party relationships.

In addition, we may identify, or regulatory authorities may assert, instances of non-compliance that occurred prior to the acquisition or that arise following the acquisition as a result of integration challenges, differences in compliance policies or procedures, or changes in operational requirements or controls, which may have a negative impact on our business, our interactions with regulatory authorities and our reputation.

There may also be general economic, political, market and business conditions, or future exchange and interest rate changes, or changes in tax laws, regulations, rates and policies, that could have a negative impact on the combined organization.

In addition, LUMRYZ, the marketed product acquired in the Avadel Acquisition, could be shown to be ineffective or unsafe, may prove difficult to have manufactured, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse and we may not be able to continue to successfully commercialize LUMRYZ or support its revenue growth.

Any of the foregoing or other unanticipated events may result in our not achieving the operational, financial, strategic and other benefits and synergies we anticipate realizing as a result of the acquisition within the expected timeframe or at all, or they may take longer to realize or cost more than expected, and in each case, our business, results of operations and financial condition and/or the market price for our ordinary shares could be adversely affected.

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.

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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.

For example, we have received civil investigative demands from U.S.

federal and state authorities and have cooperated, or are cooperating, with the government in each instance.

If, as a result of government requests, proceedings are initiated, including under the U.S.

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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.

For example, and as discussed above, the Inflation Reduction Act includes several provisions that will impact our business to varying degrees, including those that imposed 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, 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.

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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 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 successfully commercializing and/or bringing to market 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.

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.

We also earn manufacturing revenues for the manufacture of RISPERDAL CONSTA on behalf of Janssen.

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.

For example, we receive substantial revenue from Janssen’s sales of XEPLION, INVEGA TRINZA/TREVICTA, INVEGA HAFYERA/BYANNLI, 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.

In addition, generic versions of certain of these products have been launched, and others could be launched in the future, and there has been, and may in the future be, adverse impacts 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.

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• an inability to manufacture or obtain sufficient quantities of materials used for clinical trials;

• 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.

• unforeseen governmental or regulatory issues or concerns, including those of the FDA, the DEA 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 which are newer to us.

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.

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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.

The FDA and DEA (to the extent a product is a controlled substance) 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.

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• data from preclinical testing and clinical trials may be interpreted by applicable regulatory agencies in different ways than we or our licensees interpret it;

• 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;

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 third-party contract manufacturers 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;

• regulatory agencies may change their requirements for approval or post-approval marketing, including potential imposition or modification of a REMS;

• 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.

government shutdown, such as the one that occurred in the fall of 2025, significant changes in FDA leadership or personnel, or other global, political or economic conditions or circumstances, 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.

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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.

Our business could be seriously harmed if we do not complete these post-approval requirements or if the FDA or other regulatory agencies require us to change the label for any product, or if such post-approval requirements significantly restrict the marketing, sale or use of any product.

For example, we are required to maintain a REMS for LUMRYZ because its API consists of sodium oxybate, a central nervous system depressant known to be associated with serious potential side effects.

The REMS imposes, among other requirements, controls and restrictions on the distribution of the product in the U.S.

Any failure to demonstrate our substantial compliance with such REMS obligations, including as a result of business or other interruptions, or a determination by the FDA that the REMS is not meeting its goals, could result in enforcement action by the FDA , including potential withdrawal of the product from the market or required changes to our REMS obligations, any of which could negatively affect sales of LUMRYZ, result in additional costs and expenses for us or require us to invest a significant amount of resources, any of which could significantly affect our business, financial condition, cash flows and results of operations.

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.

Disruptions at the FDA and other regulatory agencies that are unrelated to our company or our products, including due to changes in government or significant changes in leadership or personnel, 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.

Average review times for product submissions have fluctuated in recent years as a result.

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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.

government has shut down several times, including in the fall of 2025, 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.

We may not be able to successfully expand our R&D pipeline or our commercial product portfolio, which could limit our growth potential.

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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.

For example, we recently completed the Avadel Acquisition, which added LUMRYZ to our commercial portfolio and added valiloxybate to our portfolio of development candidates.

However, we may not be able to successfully complete any additional transactions in the future, as such transactions are often 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.

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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.

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 remain, or 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.

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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.

We rely solely on our manufacturing facility in Wilmington, Ohio for the manufacture of ARISTADA, ARISTADA INITIO, LYBALVI, RISPERDAL CONSTA and VIVITROL.

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.

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.

In addition, any significant personnel shortages at our manufacturing facility, whether temporary or prolonged, including shortages related to the labor market, may cause significant interruptions to our supply of products.

We are also dependent in certain cases on third parties who manufacture or distribute certain products that we commercialize or from which we receive revenue.

Supply or manufacturing issues related to products using our proprietary technologies or licensed products could materially adversely affect sales of such products, and in turn our revenue from such products.

For example, LUMRYZ is manufactured by a number of third-party contract manufacturers on which we rely and, due to regulatory and technical requirements, we have limited ability to shift production to alternative contract manufacturers in the event of an interruption in manufacturing or demand for manufacturing that exceeds such contract manufacturers’ capacity.

Any need to transition manufacturing 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 LUMRYZ.

In addition, VUMERITY, a licensed product for which we receive royalties, was previously manufactured by us and is now manufactured exclusively by Biogen and its designees, and we no longer have any control over its manufacturing.

Supply or manufacturing issues related to our proprietary products, products using our proprietary technologies, or our licensed 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 our products.

We rely on third parties for the timely supply of goods and services that play a role in the manufacture and distribution of our products, including, among others, specified raw materials, equipment, contract manufacturing, formulation and packaging services, operation of the LUMRYZ REMS, 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.

These third parties must comply with U.S.

federal, state and local regulations applicable to their business, including FDA and, as applicable, DEA regulations.

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.

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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.

market—Cardinal Health Inc., Cencora, and McKesson Corp—in the distribution of ARISTADA and ARISTADA INITIO, LYBALVI and VIVITROL.

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.

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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.

Additionally, in the U.S., the DEA and state-level agencies heavily regulate the manufacturing, holding, processing, security, recordkeeping and distribution of substances, including controlled substances.

Our products that are scheduled by the DEA as controlled substances make us subject to the DEA’s regulations.

We and our third-party providers are subject to unannounced inspections by the FDA, the DEA 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.

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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

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.

however, the FDA may not consider our risk management program to be sufficient upon inspection and we may still experience shortages in the supply of marketed products that we manufacture or that are manufactured on our behalf by third parties, 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.

have inspected and approved our commercial manufacturing facility.

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.

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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.

LUMRYZ is a controlled substance subject to U.S.

federal and state-controlled substance laws and regulations, and any failure to comply with these laws and regulations, or the cost of compliance with these laws and regulations, could materially adversely affect our business, financial condition, cash flows and results of operations.

Controlled substances as defined in the CSA are subject to a number of requirements and restrictions under the CSA and implementing regulations, including certain registration, security, recordkeeping, reporting, import, export, prescription, distribution and other requirements administered by the DEA.

Individual states have also established controlled substance laws and regulations.

FDA-approved products such as LUMRYZ, which contain sodium oxybate (a Schedule I controlled substance) as their API, are deemed to be Schedule III controlled substances under the CSA.

Although state-controlled substances laws often mirror federal law, various states may also separately schedule LUMRYZ.

We or the third-parties with which we work to develop, manufacture and/or commercialize controlled substances such as LUMRYZ may be required to obtain separate state registrations, permits or licenses in order to be able to manufacture, research, distribute, import, export, administer or prescribe such controlled substances for clinical trials or commercial sale, and failure to meet applicable regulatory requirements could lead to enforcement and sanctions by the states in addition to those from the DEA or otherwise arising under federal law.

facilities conducting research, manufacturing, distributing, importing or exporting, or dispensing of controlled substances such as LUMRYZ must be registered and/or licensed to perform these activities and must comply with the security, control, recordkeeping and reporting obligations under the CSA, DEA regulations and corresponding state requirements.

DEA and state regulatory bodies conduct periodic inspections of certain registered establishments that handle controlled substances.

Obtaining and maintaining necessary registrations and quotas and complying with the regulatory obligations may result in delays in the development, manufacture and commercialization of LUMRYZ and future product candidates or products that may contain controlled substances.

Furthermore, failure to maintain compliance with the CSA and DEA and state regulations by us or any of contractors, distributors or pharmacies with which we work can result in regulatory action that could materially adversely effect our business, financial condition, cash flows and results of operations.

In addition, if we change any third-party upon whom we rely to conduct our research, manufacturing, distributing, importing, exporting, or dispensing activities, doing so will result in additional costs and expenses and may take a significant amount of time, and we may be unsuccessful in identifying a new, satisfactory third-party, any of which could materially and adversely affect our business, financial condition, and results of operations.

DEA and state regulatory bodies may seek civil penalties, refuse to renew necessary registrations or licenses, or initiate proceedings to restrict, suspend or revoke those registrations or licenses.

In certain circumstances, violations could lead to criminal penalties.

We and the third parties that manufacture LUMRYZ in the U.S.

are subject to the DEA’s annual manufacturing and procurement quota requirements.

The annual quota allocated to us or our U.S.

manufacturing partners for sodium oxybate may not be sufficient to meet commercial demand of LUMRYZ.

Consequently, any delay or refusal by the DEA in establishing our, or U.S.

manufacturing partners’, procurement and/or production quotas for controlled substances could delay or stop our commercial activities and future development/clinical activities, which could materially adversely effect our business, financial condition, cash flows and results of operations.

Our success largely depends upon our ability to attract, recognize and retain key personnel.

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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.

The loss of key personnel due to any of these or other 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

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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.

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

There is considerable uncertainty within the biopharmaceutical industry about the validity, scope and enforceability of many issued patents in the U.S.

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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.

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.

7,919,499 that cover VIVITROL, which petition has not yet been instituted.

For example, in December 2024, Argentum Pharmaceuticals LLC filed a request with the USPTO for ex parte reexamination (“EPR”) of the validity of certain claims of our U.S.

7,919,499 that covers VIVITROL, and in January 2025, Apotex Inc.

filed with the USPTO a petition for IPR of certain claims of the same patent.

In July 2025, the USPTO discretionarily denied institution of the IPR and in October 2025, confirmed the validity of the claims challenged under the EPR and found that several additional claims we filed were patentable.

While both of these challenges were ultimately resolved in our favor, they required expenditure of time, effort and resources and there can be no assurance that we would achieve similar outcomes if our patents continue to be challenged in the future.

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.

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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.

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 was invalid, unenforceable and/or would 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.

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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.

And in July 2019, in order to resolve an IPR instituted by Amneal with the PTAB, we entered into a settlement and license agreement with Amneal, pursuant to which 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 2028 or earlier under certain circumstances, and later entered into the AG Agreement with Amneal, pursuant to which we granted Amneal certain rights to distribute and sell in the U.S.

an authorized generic version of VIVITROL for a one-year term beginning on the date of a Third Party ANDA Product Launch (as defined in the AG Agreement), subject to certain conditions set forth in the AG Agreement.

There can be no assurance that we or our licensees will prevail or settle any IP legal proceedings or disputes on favorable terms.

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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.

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At December 31, 2025, our accumulated deficit was $0.7 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;

Factors that may impact our future revenue, and in turn our future profitability, include, among others, our, our third-party contract manufacturers or our licensees’ (as applicable) ability to:

• successfully commercialize VIVITROL, the ARISTADA product family, LYBALVI, LUMRYZ, 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.

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• successfully protect and defend our confidential information and IP rights related to our technologies and our products;

• maintain regulatory exclusivities or the benefits of such exclusivities;

• achieve product development or sales milestones under our collaborative arrangements;

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subsidiaries will be classified as a CFC.

The OBBBA reinstated the prohibition on downward attribution of stock from a foreign person to a U.S.

person and therefore we do not expect any of our non-U.S.

subsidiaries to be classified as CFCs in 2026.

Existing and prospective investors should consult their tax advisers regarding the potential application of these rules to their investments in our securities.

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could change on a prospective or retroactive basis, and any such changes could adversely affect us.

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.

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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.

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.

In connection with the separation of our oncology business into Mural Oncology plc (“Mural”) 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.

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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 were based on and relied on, among other things, certain facts, assumptions, representations, and undertakings from us and Mural, 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 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.

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In such an event, we and/or our shareholders could incur significant tax liabilities.

In April 2025, Mural announced its intent to discontinue all clinical development of nemvaleukin alfa following a review of clinical trial data, reduce its workforce by approximately 90% and commence the exploration of strategic alternatives focused on maximizing shareholder value.

In August 2025, Mural and XOMA Royalty Corporation announced a definitive agreement for XOMA Royalty’s wholly owned subsidiary to acquire all issued and to be issued share capital of Mural, which was completed in December 2025.

We do not believe that these events will adversely affect the tax treatment of the separation;

however, the IRS or the courts may challenge this position and should any such challenge prevail, we and/or our shareholders that are subject to U.S.

federal income tax could incur significant tax liabilities.

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

In connection with the Avadel Acquisition, we entered into the Credit Agreement (as defined below) pursuant to which we incurred indebtedness of approximately $1.525 billion.

The degree of our indebtedness could have important consequences, including:

• increasing our vulnerability to adverse economic, industry or competitive developments;

• requiring a substantial portion of our cash flow from operations to be dedicated to the payment of principal and interest on our indebtedness, thereby reducing our ability to use our cash flow to fund our operations, capital expenditures and other business opportunities;

• limiting our flexibility to plan for, or react to, changes in our business and industry, or our ability to take specified actions to take advantage of certain business opportunities that may be presented to us;

• exposing us to variability in interest rates;

• limiting our ability to return capital to our shareholders, including through share repurchases;

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

In addition, the Credit Agreement requires the maintenance of certain leverage and coverage ratios, in each case with the levels set forth in the Credit Agreement, as of the last day of any fiscal quarter.

In addition, the Credit Agreement contains customary affirmative and negative covenants, including limitations on indebtedness, liens, mergers, consolidations, sales of assets, investments, transactions with affiliates, restricted payments and sales and leasebacks.

The Credit Agreement is guaranteed by certain of the

Company’s subsidiaries and secured by a lien on substantially all of the assets of Alkermes plc, Alkermes, Inc.

and the subsidiary guarantors.

Any failure to comply with these restrictions or to make payments could lead to an event of default that could result in an acceleration of the indebtedness.

Our future operating results may not be sufficient to ensure our ability to make our debt payments or to remedy any such default.

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 indebtedness.

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.

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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.

For example, as described above, we entered into the Credit Agreement in connection with the Avadel Acquisition.

The source, timing and availability of any future additional 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.

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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

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.

If we are unable to obtain renewal of share issuance authorities from our shareholders, or are otherwise 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.

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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.

See “Item 1C—Cybersecurity” in this Annual Report for additional information relating to our cybersecurity risk management strategy, governance and oversight.

We may be subject to numerous and varying privacy and security laws, and any 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.

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General Risk Factors

Changes in global trade or other policies, including tariffs or other restrictions imposed by the U.S.

government or governments of other nations, could have an adverse effect on our business, results of operations, or financial condition.

As a global biopharmaceutical company, changes in and uncertainties from global trade or other policies, including tariffs or other restrictions imposed by the U.S.

government or governments of other nations, may have an adverse effect on us.

For example, since April 2025, the U.S.

government and certain other countries have imposed tariffs or negotiated trade agreements for tariffs on certain imports.

Although some of these tariffs are temporarily paused, their impact has already been seen, and we expect will continue to be seen, in global markets.

The majority of our proprietary products are manufactured at our manufacturing facility in the U.S.

and are sold exclusively in the U.S.;

however, certain materials in our supply chain are sourced internationally, certain elements of manufacturing for LUMRYZ are manufactured outside of the U.S., and certain third-party products from which we derive revenue are manufactured outside the U.S.

Our related costs, revenues and/or profits may be impacted to varying degrees by recent or future changes in global trade or other policies.

In addition, the recent changes, tensions and uncertainties related to global trade policies have caused, and may continue to cause, significant volatility in global markets, including the market for our ordinary shares.

The price of our ordinary shares has fluctuated significantly, and may continue to fluctuate, as a result of these and similar developments.

government has also indicated that it may impose a supplemental tariff on all pharmaceutical imports or take additional actions in respect of pharmaceutical companies incorporated outside of the U.S., which has caused, and may continue to cause, uncertainty as to the extent of the impacts of changes in global trade on the pharmaceutical industry as a whole and on our business.

Additional changes to the policies of the U.S.

or other nations that affect the geopolitical landscape or global trade, economic or market conditions, and other direct or indirect impacts of such policies, are uncertain and unpredictable, and could, in the future, have a material adverse effect on our business, results of operations, or financial condition and the market price of our ordinary shares.

A future pandemic, epidemic or outbreak of an infectious disease, may materially and adversely affect our business, financial condition and results of operations.

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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.

Additionally, the use of artificial intelligence (“AI”) tools 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.

There is a risk that we or our employees may use social media and AI to communicate about our products or business or for other business purposes that may cause us to be found in violation of applicable requirements and could result in regulatory actions or legal claims against us, including claims 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 or AI policies 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.

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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.

The secure maintenance of such information and the secure performance of our 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.

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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 .

Information Systems Acquired in the Avadel Acquisition

In February 2026, we completed the Avadel Acquisition.

The information technology and operational systems utilized by Avadel prior to the acquisition currently remain separate from those of Alkermes.

In advance of integration with our own systems, we are conducting a comprehensive assessment of the design and effectiveness of Avadel’s systems, processes, and related risks, including cybersecurity, data protection, and operational resilience considerations.

Upon completion of this assessment, we expect to begin a phased operational and systems integration to align the acquired operations with our enterprise standards and infrastructure.

We plan to address any security events that may arise involving Avadel’s systems in a manner that is consistent with our enterprise incident response expectations.

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.

This lease expires in January 2027 and does not include an additional tenant option to further extend the term.

In December 2025, we entered into a lease agreement for an approximately 6,675 square foot corporate office space in Athlone, Ireland.

The initial term of the lease commenced on January 1, 2026, expires on December 31, 2030 and includes an option to extend for an additional five-year period.

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 lease an approximately 17,065 square foot corporate office and administrative space in Chesterfield, Missouri.

This lease expires in 2029 and includes a tenant option to extend the term for an additional three-year period.

We own an approximately 375,000 square foot manufacturing facility in Wilmington, Ohio.

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What changed 10-K

Item 1A. Risk Factors