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What changed in PERRIGO Co plc's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of PERRIGO Co plc's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+486 added−416 removedSource: 10-K (2026-02-26) vs 10-K (2025-02-28)

Top changes in PERRIGO Co plc's 2025 10-K

486 paragraphs added · 416 removed · 204 edited across 10 sections

Item 1. Business

Business — how the company describes what it does

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Biggest changeActual results may vary from the guidance we provide investors from time to time, such that our stock price may decline following, among other things, any earnings release or guidance that does not meet market expectations. It has become increasingly commonplace for investors to file lawsuits against companies following a rapid decrease in market capitalization.
Biggest changeIt has become increasingly commonplace for investors to file lawsuits against companies following a rapid decrease in share price.
We have been in the past, are currently, and may be in the future, named in these types of lawsuits. These types of lawsuits can be costly and divert management attention and other resources away from our business, regardless of their merits, and could result in adverse settlements or judgments.
We have been in the past, are currently, and may be in the future, named in these types of lawsuits, which can be costly and divert management attention and other resources away from our business, regardless of their merits, and could result in adverse settlements or judgments, which could have a material impact on our reputation, business, and results of operation.
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Business - Government Regulations and Pricing , for changes to tax and import/export laws and trade and customs policies (including the enactment of tariffs on goods imported into the U.S., including but not limited to, goods imported from China), problems related to markets with different cultural norms or political systems, possible difficulties in enforcing agreements, longer payment cycles and shipping lead-times, difficulties obtaining export or import licenses, and imposition of withholding or other taxes.
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Additionally, if we are unable to maintain adequately high levels of customer service over time, customers may choose to assess penalties (where such penalties are contractually permitted), obtain alternate sources for products, and/or end their relationships with us. 20 Perrigo Company plc - Item 1A Risk Factors Our businesses could be adversely affected by deteriorating economic conditions in the countries in which we operate, shifts in the retail landscape, and changes in consumer behavior, and our results may be volatile due to these or other circumstances beyond our control.
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Moreover, the trade policies of the new U.S. presidential administration could result in substantial changes to tax or fiscal policies that could impact our business.
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Our customers could be adversely impacted if economic conditions worsen in the U.S. or other countries in which we operate. In the U.S., our consumer self-care business does not advertise our store brand products like national brand companies and thus, is largely dependent on retailer promotional activities to drive sales volume and increase market share.
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For example, the administration has imposed, or indicated a willingness to impose, significant tariffs on products imported from a number of countries, which could impact our API procurement, products and manufacturing, or give rise to retaliatory tariffs on U.S. goods by those countries.
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If our customers do not have the ability to invest in store brand promotional activities, our sales may suffer. Additionally, while we actively review the credit worthiness of our customers and suppliers, we cannot fully predict to what extent they may be negatively impacted by slowing economic growth.
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Additionally, we are subject to periodic reviews and audits by governmental authorities responsible for administering import and export regulations. To the extent that we are unable to successfully defend against an audit or review, we may be required to pay assessments, penalties, and increased duties. Certain of our facilities operate in a special purpose sub-zone established by the U.S.
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Our stock price has declined and may continue to decline due to any earnings release or guidance that does not meet market expectations or other circumstances, which may be beyond our control, such as the severity, length and timing of the cough/cold/flu and allergy seasons, the timing of new product approvals and introductions by us and our competitors, and the timing of retailer promotional programs.
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Department of Commerce Foreign Trade Zone Board, which allows us certain tax advantages on products and raw materials shipped through these facilities. If the Foreign Trade Zone Board were to revoke the sub-zone designation or limit our use, we could be subject to increased duties.
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Changes in the retail landscape and consumer behavior may adversely affect our business, financial condition, and results of operations.
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Although we believe that we conduct our business in compliance with applicable anti-corruption, anti-bribery and economic sanctions laws, if we are found to not be in compliance with such laws or other anti-corruption laws, we could be subject to governmental investigations, legal or regulatory proceedings, substantial fines, and/or other legal or equitable penalties.
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The increasing prevalence of alternative sales channels, such as e‑commerce, direct‑to‑consumer online brands, subscription services, and buying clubs, together with evolving consumer preferences, demand patterns, shopping behaviors, and consumption levels, may result in pressure on pricing, and shift market share in ways that are difficult to predict. These dynamics could adversely affect our business, results of operations, and financial condition.
Removed
This risk increases in locations outside of the U.S., particularly in locations that have not previously had to comply with the FCPA, U.K. Bribery Act 2010, Irish Criminal Justice (Corruption Offenses) Act 2018, and similar laws. We operate in jurisdictions that could be affected by economic and geopolitical instability, which could have a material adverse effect on our business.
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Our performance is also dependent on discretionary consumer spending, which is influenced by factors beyond our control, including general economic and political conditions, consumer confidence, interest rates, inflation, tax rates, credit availability, employment levels, and housing and financial market conditions. Deterioration in any of these factors could reduce customer spending and adversely affect our net sales and profitability.
Removed
Our operations and supply partners could be affected by economic or political instability, embargoes, military hostilities, unstable governments and legal systems, inter-governmental disputes, travel restrictions, terrorist acts, and other armed conflicts. The global nature of our business involves the following risks, among others: • The U.S.
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Our performance is also influenced by consumer trends, habits, and preferences. A shift away from traditional medicine or changes in other preferences could diminish demand for our products and reduce sales.
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Department of State and other governments have at times issued advisories regarding travel to certain countries in which we do business, causing regulatory agencies to curtail or prohibit their inspectors from traveling to inspect facilities.
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As a result of these and other risks and uncertainties, our future sales, earnings, and cash flows could be volatile and vary materially from our expectations, including our published guidance.
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If these inspectors are unable to inspect our facilities, the regulatory agencies could withhold approval for new products intended to be produced at those facilities. • As a result of the exit of the U.K. from the E.U. (“Brexit”), which occurred in 2020, we continue to experience uncertainty surrounding certain of our businesses.
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Our ability to achieve operating results in line with published guidance is inherently subject to significant uncertainties, and related share-price volatility may heighten our susceptibility to investor lawsuits and activist shareholder activity.
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While the E.U. and U.K. ratified a Trade and Cooperation Agreement (the “TCA”) that sets forth a framework for cooperation between the E.U. and U.K., including the mutual recognition of GMP inspections of manufacturing facilities for medicinal products, it does not contain wholesale mutual recognition of pharmaceutical regulations and product standards, and the E.U. and the U.K. continue to amend legislation and regulations post-Brexit.
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Our financial projections, including any sales, earnings guidance, or outlook we may provide to investors from time to time, are forward-looking statements based on estimates and assumptions that are uncertain and subject to risks, contingencies, and factors beyond our control.
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We continue to monitor for divergence between E.U. and U.K. regulations that could negatively impact our supply chain operations or other product development or sales operations. Moreover, financial volatility and geopolitical instability outside the U.S. may impact our operations or affect global markets.
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These estimates and assumptions may be adversely affected by the risks described in this Report and by other uncertainties, and actual results may vary and differ materially from those expressed or implied by such projections or guidance. Any failure to meet market expectations, or change to, our projections or guidance may adversely affect the market price of our ordinary shares.
Removed
As noted above, the war in Ukraine and the conflict in the Middle East continue to impact our operations and supply chain and any escalation of these conflicts could have a larger impact that expands into other markets where we do business, including our supply chain, business partners and customers in the broader region, which could result in lost sales, supply shortages, increase manufacturing costs and lost efficiencies.
Added
A decline in our share price may also increase our vulnerability to activist shareholder actions. Responding to activist campaigns or a potential proxy contest may require significant time, attention, and resources from management and our Board and may result in substantial legal, advisory, and administrative expenses.
Removed
Further, the conflict may adversely impact macroeconomic conditions and increase volatility in and affect our ability to access capital markets and external financing sources on acceptable terms or at all.
Added
Investor perception of activist activity may also increase share price volatility, and the associated distraction and resource demands could impede our ability to execute our business strategy and related strategic initiatives, adversely affecting our business, financial condition, and results of operations.
Removed
Given the international scope of our operations, such effects of ongoing wars and armed conflicts, and others we cannot anticipate, could adversely affect our business, business opportunities, operations, and financial results. 26 Perrigo Company plc - Item 1A Risk Factors The international scope of our business exposes us to risks associated with foreign exchange rates.
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Our exposure to cybersecurity threats and third‑party information system vulnerabilities could result in a material adverse effect on our business. Our business operations are increasingly dependent upon information technology systems that are highly complex, interrelated with our external business partners, and may contain confidential information (including personal data, trade secrets or other intellectual property, or proprietary business information).
Removed
We report our financial results in U.S. dollars. However, a significant portion of our revenues, expenses, assets, indebtedness and other liabilities are denominated in foreign currencies. These currencies include, among others, the Euro, British pound, Canadian dollar, Swedish Krona, Chinese Yuan, Danish Krone, and Polish Zloty.
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The nature of digital systems, both internally and externally, makes them potentially vulnerable to disruption or damage from human error and/or security breaches, which include, but are not limited to, ransomware, data theft, denial of service attacks, sabotage, 21 Perrigo Company plc - Item 1A Risk Factors industrial espionage, interruptions or other system issues, unauthorized access and computer viruses.
Removed
Fluctuations in currency exchange rates, including as a result of inflation, central bank monetary policies, currency controls or other currency exchange restrictions have had, and could continue to have, an adverse impact on our financial performance. We may seek to mitigate the risk of such impacts through hedging, but such hedging activities may be costly and may not be effective.
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Such events may be difficult to detect, and once detected, their impact may be difficult to assess and address. Cyber-attacks have become increasingly common. We have experienced immaterial business disruption, monetary loss and data loss as a result of phishing, business email compromise and other types of attacks.
Removed
In addition, emerging market economies in which we operate may be particularly vulnerable to the impact of rising interest rates, inflationary pressures, weaker oil and other commodity prices, and large external deficits. Risks in one country can limit our opportunities for portfolio growth and negatively affect our operations in another country or countries.
Added
In addition, the rapid evolution and increased adoption of new technologies, such as artificial intelligence, may intensify our cybersecurity risks.
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Such conditions or developments could have an adverse impact on our operations. In addition, we may be exposed to credit risks in some of those markets. Litigation and Insurance Risks We are or may become involved in lawsuits and may experience unfavorable outcomes of such proceedings.
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While we continue to employ resources to monitor our systems and protect our infrastructure, these measures may prove insufficient, and that could subject us to significant risks, including, without limitation: • Ransomware attacks, other cyber breaches or disruptions that impair our ability to develop products, meet regulatory approval requirements or deadlines, produce or ship products, take or fulfill orders, and/or collect or make payments on a timely basis; • System issues, whether as a result of an intentional breach, a natural disaster or human error that damage our reputation and cause us to lose customers, experience lower sales volume, and/or incur significant liabilities; • Significant expense to remediate the results of any attack or breach and to ensure compliance with any required disclosures mandated by the numerous global privacy and security laws and regulations; and • Interruptions, security breaches, loss, misappropriation, or unauthorized access, use or disclosure of confidential information, which, individually or collectively, could result in financial, legal, business or reputational harm to us and could have a material adverse effect on our business, financial condition and results of operations.
Removed
We may become involved in lawsuits arising from a wide variety of commercial, manufacturing, development, marketing, sales and other business-related matters, including, but not limited to, competitive issues, pricing, contract issues, intellectual property matters, false advertising, antitrust or unfair competition, taxation matters, workers' compensation, product quality/recall, environmental remediation, securities law, disclosure, product liability and regulatory issues.
Added
Our inability to timely and responsibly leverage emerging technologies, including generative artificial intelligence, could result in a material adverse effect on our business, and the use of emerging technologies generally could result in regulatory action, legal liability, operational challenges or reputational harm.
Removed
Litigation is unpredictable and could result in potentially significant monetary damages, and we could incur substantial legal expenses, even if a claim against us is unsuccessful. We intend to vigorously defend against any lawsuits, however, we cannot predict how the cases will be resolved. Adverse results in, or settlements of, such cases could result in substantial monetary judgments.
Added
Our ability to identify, adopt, and effectively integrate emerging technologies, including generative artificial intelligence (“AI”), into our product development, services, and operations is an important factor in maintaining our competitiveness. If we are unable to timely and responsibly leverage such technologies, our operating results, and growth prospects could be adversely affected.
Removed
No assurance can be made that litigation will not have a material adverse effect on our reputation, financial position or results of operations in the future. Refer to Item 8. Note 19 .
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Increased use of AI introduces certain risks, including heightened exposure to cybersecurity threats, data privacy and intellectual property concerns, algorithmic errors or bias leading to flawed outputs or poor decision-making, and increased third-party dependency risks. Additionally, the legal and regulatory landscape governing AI is rapidly evolving in the United States and globally.
Removed
The actual or alleged presence of certain hazardous substances or petroleum products on, under or in our currently or formerly owned property, or from a third-party disposal facility that we may have used, or the failure to remediate them, could have adverse effects, including, for example, substantial investigative or remedial obligations and limitations on our ability to sell or rent affected property or to borrow funds using affected property as collateral.
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Changes in, or noncompliance with, applicable laws, regulations, standards, and industry guidance could result in increased compliance costs, operational constraints, liability, or reputational harm.
Removed
There can be no assurance that environmental liabilities and costs will not have a material adverse effect on us. Refer to Item 1. Business - Environmental for more information related to environmental remediation matters.
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While we have implemented, and expect to continue enhancing, governance, security, and quality control measures related to the use of AI and other emerging technologies, these measures may not be effective in all cases, and we may incur significant costs or face unanticipated consequences as these technologies and their regulatory frameworks continue to develop.
Removed
Increased scrutiny on pricing practices and competition, including antitrust enforcement activity by government agencies and class action litigation, may have an adverse impact on our business and operating results, which could be material.
Added
We are subject to data privacy laws and regulations and our failure in compliance could result in a material adverse effect on our business.
Removed
There has been increased scrutiny regarding sales, marketing, and pricing practices, including criminal antitrust investigations regarding drug pricing, civil False Claims Act investigations relating to drug pricing and marketing, multiple civil antitrust litigation initiated by governmental and private plaintiffs against pharmaceutical manufacturers and individuals, and related media reports.
Added
We are subject to numerous laws and regulations designed to protect personal data, such as the California Consumer Privacy Act and other similar state laws in the U.S., the U.K.'s Data Protection Act of 2018 and the European General Data Protection Regulation ("GDPR").
Removed
Perrigo has been named as a co-defendant with certain other generic manufacturers in a number of class action, individual plaintiff direct action, State Attorney General, and county lawsuits alleging that we engaged in anti-competitive behavior to fix or raise the prices of certain drugs starting, in some instances, as early as calendar year 2010. Refer to Item 8.
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These data protection laws introduced more stringent data protection requirements and significant potential fines, as well as increased our responsibility and potential liability in relation to personal data that we process and possess.
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Note 19 . While we intend to defend these lawsuits vigorously, any adverse decision could have a material adverse impact on our business, results of operations and reputation.
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Compliance with such laws requires significant time and resources and may impose significant challenges that are likely to continue to increase over time, particularly as additional regulatory agencies adopt similar or new requirements. We have put mechanisms in place to ensure compliance with applicable data protection laws, but there can be no guarantee of their effectiveness.
Removed
In addition, in May 2018, Perrigo was also served with and responded to a civil investigative demand in connection with a related civil False Claims Act investigation by the Civil Division of the Department of Justice.
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For more information regarding our cybersecurity activities, please refer to
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Although no charges or other related civil claims have been brought to date against Perrigo or any of our current employees (or, to the best of our knowledge, former employees), by the Department of Justice, we take the investigation very seriously. 27 Perrigo Company plc - Item 1A Risk Factors Third-party patents and other intellectual property rights may limit our ability to bring new products to market and may subject us to potential legal liability, which could have a material adverse effect on our business and operating results.
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The manufacture, use and sale of new products that are the subject of conflicting patent rights have been the subject of substantial litigation in the self-care and pharmaceutical industries. • As a manufacturer of generic products, the ability of our CSCA and CSCI segments to bring new products to market is often limited by third-party patents or proprietary rights and regulatory exclusivity periods awarded on products.
Removed
Launching new products prior to resolution of intellectual property issues may result in us incurring legal liability if the related litigation is later resolved against us. The cost and time for us to develop Rx-to-OTC switch products is significantly greater than the rest of the new products that we introduce.
Removed
Any failure to bring new products to market in a timely manner could cause us to lose market share, and our operating results could suffer. • We may have to defend against charges that we infringed patents or violated proprietary rights of third parties.
Removed
This could require us to incur substantial expense and could divert significant effort of our technical and management personnel. If we are found to have infringed rights of others, we could lose our right to develop or manufacture some products or could be required to pay monetary damages or royalties to license proprietary rights from third parties.
Removed
Additionally, if we choose to settle a dispute through licensing or similar arrangements, the costs associated with these arrangements may be substantial and could include ongoing royalties.
Removed
An adverse determination in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent us from manufacturing and selling a number of our products. • At times, our CSCA segment may seek approval to market drug products before the expiration of a third party's patents for therapeutically equivalent products, based upon our belief that such patents are invalid, unenforceable or would not be infringed by our products.
Removed
In these cases, we may face significant patent litigation.
Removed
Depending upon a complex analysis of a variety of legal and commercial factors, we may, in certain circumstances, elect to market a store brand or generic product while litigation is pending, before any court decision, or while an appeal of a lower court decision is pending, known as an "at risk" launch.
Removed
The risk involved in an "at risk" launch can be substantial because, if a patent holder ultimately prevails, the remedies available to the patent holder may include, among other things, damages measured by the profits lost by the holder, which are often significantly higher than the profits we make from selling the generic version of the product.
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By electing to proceed in this manner, we could face substantial damages if we receive an adverse final court decision.
Removed
In the case where a patent holder is able to prove that our infringement was "willful" or "exceptional," under applicable law, the patent holder may be awarded up to three times the amount of its actual damages or we may be required to pay attorneys’ fees.
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The success of certain of our products depends on the effectiveness of measures we take to protect our intellectual property rights and patents.
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If we fail to adequately protect our intellectual property, competitors may manufacture and market similar products. • We have been issued patents covering certain of our products, and we have filed, and expect to continue to file, patent applications seeking to protect newly developed technologies and products in various countries.
Removed
Any existing or future patents issued to or licensed by us may not provide us with any significant competitive advantages for our products or may even be challenged, invalidated, or circumvented by competitors.
Removed
In addition, patent rights may not prevent our competitors from developing, using, or commercializing non-infringing products that are similar or functionally equivalent to our products. • We also rely on trade secrets, unpatented proprietary know-how, and continuing technological innovation that we seek to protect, in part by confidentiality agreements with licensees, suppliers, employees, and consultants.
Removed
If these agreements are breached, we may not have adequate remedies for any such breach. Disputes may arise concerning the ownership of intellectual property or the applicability of confidentiality agreements.
Removed
Furthermore, trade secrets and proprietary technology may otherwise become known or be independently developed by competitors or, if patents are not issued with respect to products arising from research, we may not be able to maintain the value of such intellectual property rights. 28 Perrigo Company plc - Item 1A Risk Factors Our ability to achieve operating results in line with published guidance is inherently subject to numerous risks and other factors beyond our control.
Removed
Publishing earnings guidance subjects us to risks, including increased stock volatility, that could lead to potential lawsuits by investors. Because we publish earnings guidance, we are subject to several risks. Earnings guidance is inherently uncertain and subject to factors beyond our control.
Removed
The inherent uncertainty of earnings guidance and related lawsuits could have a material impact on us. Significant increases in the cost or decreases in the availability of the insurance we maintain could adversely impact our operating results and financial condition. Disputes with insurers on the scope of existing policies may limit the coverage available under such policies.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeRISK FACTORS SUMMARY OF RISK FACTORS Operational Risks • We face competition from other consumer packaged goods and pharmaceutical companies, which may threaten the demand for and pricing of our products. • If we do not continue to develop, manufacture, and market innovative products, introduce new line extensions, and expand into adjacent categories that meet customer demands, our net sales may be negatively impacted and we may lose market share. • We operate in highly regulated industries, and any inability to timely meet current or future regulatory requirements could have a material adverse effect on our business and operating results. • Limitations on reimbursement, continuing healthcare reforms, and changes to reimbursement methods in the United States and other countries may have an adverse effect on our financial condition and operating results. • Unfavorable publicity or consumer perception of the safety, quality, and efficacy of our products could have a material adverse effect on our business. • Lack of availability, or significant increases in the cost, of raw materials used in manufacturing our products could have a material adverse effect on our profit margins and operating results. • The effects of public health outbreaks, including pandemics and epidemics, and related public and governmental actions could have a material adverse impact on our operations and our business and financial condition in the future. • Disruption of our supply chain, including as a result of pandemics, global health crises, or wars or other civil unrest, including war in Ukraine, or in the Middle East, could have a material adverse effect on our businesses, financial condition, results of operations and cash flows. • A disruption at any of our main manufacturing facilities could have a material adverse effect on our business, financial position, and results of operations. • Our business could be negatively affected by the performance of our collaboration partners and suppliers, and any such adverse impact could be material. • Our business depends upon certain customers for a significant portion of our sales, therefore our business would be adversely affected by a disruption of our relationship with these customers or any material adverse change in these customers' businesses. • Our businesses could be adversely affected by deteriorating economic conditions in the countries in which we operate, and our results may be volatile due to these or other circumstances beyond our control. • A cybersecurity breach, disruption or misuse of our information systems, or our external business partners’ information systems could have a material adverse effect on our business. • Management transition creates uncertainties, and any difficulties we experience in managing such transitions may negatively impact our business.
Biggest changeRISK FACTORS SUMMARY OF RISK FACTORS Operational Risks • We face competition from other consumer packaged goods and pharmaceutical companies, which may threaten the demand for and pricing of our products. • If we do not continue to develop, manufacture, and market innovative products, introduce new line extensions, and expand into adjacent categories that meet customer demands, our net sales may be negatively impacted and we may lose market share. • We operate in highly regulated industries, and any inability to timely meet current or future regulatory requirements could have a material adverse effect on our business and operating results. • Limitations on reimbursement, continuing healthcare reforms, and changes to reimbursement methods in the United States and other countries may have an adverse effect on our financial condition and operating results. • Unfavorable publicity or consumer perception of the safety, quality, and efficacy of our products could have a material adverse effect on our business. • Lack of availability, or significant increases in the cost, of raw materials used in manufacturing our products could have a material adverse effect on our profit margins and operating results. • Disruption of our supply chain, including as a result of pandemics, global health crises, wars or other civil unrest, including war in Ukraine, or in the Middle East, could have a material adverse effect on our businesses, financial condition, results of operations and cash flows. • A disruption at any of our main manufacturing facilities could have a material adverse effect on our business, financial position, and results of operations. • Our business could be negatively affected by the performance of our collaboration partners and suppliers, and any such adverse impact could be material. • Our business depends upon certain customers for a significant portion of our sales, therefore our business would be adversely affected by a disruption of our relationship with these customers or any material adverse change in these customers' businesses. • Our businesses could be adversely affected by deteriorating economic conditions in the countries in which we operate, shifts in the retail landscape, and changes in consumer behavior, and our results may be volatile due to these or other circumstances beyond our control. • Our ability to achieve operating results in line with published guidance is inherently subject to significant uncertainties, and related stock-price volatility may heighten our susceptibility to investor lawsuits and activist shareholder activity. • Our exposure to cybersecurity threats and third‑party information system vulnerabilities could result in a material adverse effect on our business. • Our inability to timely and responsibly leverage emerging technologies, including generative artificial intelligence, could result in a material adverse effect on our business, and the use of emerging technologies generally could result in regulatory action, legal liability, operational challenges or reputational harm. • We are subject to data privacy laws and regulations and our failure in compliance could result in a material adverse effect on our business. • Management transition and our ability to attract and retain key personnel create uncertainties, which may negatively impact our business.
Any future recall or removal would result in additional costs and lost revenue, harm our reputation, and may give rise to product liability litigation. Changes in regulation could impact the supply of the API and certain other raw materials used in our products.
Any future recall or removal would result in additional costs and lost revenue, harm our reputation, and may give rise to product liability litigation. Changes in regulation could impact the supply of API and certain other raw materials used in our products.
The failure of one of these facilities to comply with applicable laws and regulations may lead to a breach of representations made to our customers, or to regulatory or government action against us related to the products made in that facility, including suspension of or delay in regulatory approvals and product seizure, injunction, recall, suspension of production or distribution of our products, a total or partial shutdown of production in one or more facilities, loss of licenses or other governmental penalties, or civil or criminal prosecution, which could result in increased cost, lost revenue, or reputational damage. • Regulatory agencies globally, including the FDA and the European Medicines Agency, have issued guidance on assessing and controlling nitrosamine impurities in medicine products.
The failure of one of these facilities to comply with applicable laws and regulations may lead to a breach of representations made to our customers, or to regulatory or government action against us related to the facility or the products made in that facility, including suspension of or delay in regulatory approvals and product seizure, injunction, recall, suspension of production or distribution of our products, a total or partial shutdown of production in one or more facilities, remedial measures, loss of licenses or other governmental penalties, or civil or criminal prosecution, which could result in increased cost, lost revenue, or reputational damage. • Regulatory agencies globally, including the FDA and the European Medicines Agency, have issued guidance on assessing and controlling nitrosamine impurities in medicine products.
Tax Related Risks • The resolution of uncertain tax positions and ongoing disputes with U.S. and foreign tax authorities could be unfavorable, which could have a material adverse effect on our business. • Changes to tax laws and regulations or the interpretation thereof could have a material adverse effect on our results of operations and the ability to utilize cash in a tax efficient manner. • Our effective tax rate or cash tax payment requirements may change in the future, which could adversely impact our future results of operations.
Tax Related Risks • The resolution of uncertain tax positions, including any ongoing disputes with U.S. and foreign tax authorities, could be unfavorable, which could have a material adverse effect on our business. • Changes to tax laws and regulations or the interpretation thereof could have a material adverse effect on our results of operations and the ability to utilize cash in a tax efficient manner. • Our effective tax rate or cash tax payment requirements may change in the future, which could adversely impact our future results of operations.
While these programs may cover OTC products under some circumstances, utilization of our products under these programs is limited. When covering our products, these programs regulate the amount pharmacies and other healthcare providers are paid for our products. We participate in multiple programs, and are subject to associated price reporting, payment, and other compliance obligations under each. Other U.S.
While these programs may cover OTC products under some circumstances, utilization of our products under these programs is limited. When covering our products, these programs regulate the amount pharmacies and other healthcare providers are paid for our products. We participate in multiple programs, and are subject to associated price reporting, payment, and other compliance obligations under each.
In particular: • Our CSCA and CSCI segments experience direct competition from other companies, including brand name companies, that may try to prevent, discourage or delay the use of our products through various measures, including introduction of new products, legislative initiatives, changing dosage forms or dosing regimens, 16 Perrigo Company plc - Item 1A Risk Factors regulatory processes, filing new patents or patent extensions, lawsuits, citizens’ petitions, and attempts to generate negative publicity prior to our introduction of a new competitive product.
In particular: • Our CSCA and CSCI businesses experience direct competition from other companies, including brand name companies, that may try to prevent, discourage or delay the use of our products through various 15 Perrigo Company plc - Item 1A Risk Factors measures, including introduction of new products, legislative initiatives, changing dosage forms or dosing regimens, regulatory processes, filing new patents or patent extensions, lawsuits, citizens’ petitions, and attempts to generate negative publicity prior to our introduction of a new competitive product.
Additional Global Regulations and Considerations We must comply with a variety of U.S. laws related to doing business outside of the U.S., including but not limited to, Office of Foreign Asset Controls; United Nations and EU sanctions; the Iran Threat Reduction and Syria Human Rights Act of 2012; rules relating to the use of certain “conflict minerals” under Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act; and regulations enforced by the U.S.
Additional Global Regulations and Considerations We must comply with a variety of U.S. laws related to doing business outside of the U.S., including but not limited to, Office of Foreign Asset Controls; United Nations and EU sanctions; the Iran Threat Reduction and Syria Human Rights Act of 2012; rules relating to the use of certain "conflict minerals" under Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act; and regulations enforced by the U.S.
In our CSCA segment, we must prove that the regulated generic drug products are bioequivalent to their branded counterparts, which may require bioequivalence studies, and, in the case of topical products, even more extensive clinical endpoint trials to demonstrate their efficacy, and the failure to do so could also negatively impact our sales.
In our CSCA business, we must prove that the regulated generic drug products are bioequivalent to their branded counterparts, which may require bioequivalence studies, and, in the case of topical products, even more extensive clinical endpoint trials to demonstrate their efficacy, and the failure to do so could negatively impact our sales.
Certain raw materials may experience rapid cost increases due to increased labor, relevant commodities, energy costs and other inflationary pressures, and this may have a material negative impact on our financial results, whether or not we are able to pass on such increases to our customers.
Certain raw materials may experience rapid cost increases due to increased labor, relevant commodities, tariffs and other trade restrictions, energy costs and other inflationary pressures, and this may have a material negative impact on our financial results, whether or not we are able to pass on such increases to our customers.
Changes in laws, regulations, and practices in the countries in which we operate, including changes in interpretation of existing regulations (which may have retroactive effect), may be difficult or expensive for us to comply with, could restrict or delay our ability to manufacture, distribute, sell or market our products, and may adversely affect our revenue, operating results, and financial condition or impose significant administrative burdens.
Changes in laws, regulations, and practices in the countries in which we operate, including changes in interpretation of existing regulations (which may have retroactive effect) and actual or possible government shutdowns, may be difficult or expensive for us to comply with, could restrict or delay our ability to manufacture, distribute, sell or market our products, and may adversely affect our revenue, operating results, and financial condition or impose significant administrative burdens.
Our business depends upon certain customers for a significant portion of our sales, therefore our business would be adversely affected by a disruption of our relationship with these customers or any material adverse change in these customers' businesses. We have one significant customer that represented 11.9% of our consolidated net sales for the year ended December 31, 2024.
Our business depends upon certain customers for a significant portion of our sales, therefore our business would be adversely affected by a disruption of our relationship with these customers or any material adverse change in these customers' businesses. We have one significant customer that represented 12.9% of our consolidated net sales for the year ended December 31, 2025.
Negative consumer perception may arise from media reports, social media posts, product liability claims, regulatory investigations, or recalls affecting our products or our industry, any of which may reduce demand or could damage our reputation and adversely affect our business. • Our products involve risks such as product contamination, spoilage, mislabeling, and tampering that could require us to recall one or more of our products or could result in death or injury to consumers.
Negative consumer perception of our products or certain ingredients may arise from media reports, social media posts, product liability claims, regulatory investigations or other government action, or recalls affecting our products or our industry, any of which may reduce demand or could damage our reputation and adversely affect our business. • Our products involve risks such as product contamination, spoilage, mislabeling, and tampering that could require us to recall one or more of our products or could result in death or injury to consumers.
Regulations and Organizations We are subject to various other federal, state, non-governmental, and local agency rules and regulations, including among others: U.S. federal anti-bribery laws; Federal Trade Commission regulation of advertising and marketing of consumer goods; consumer product safety requirements; state and federal privacy laws and regulations; laws requiring certain pharmaceutical manufacturers to track and report payments to physicians and teaching hospitals; and non-governmental standard-setting organizations such as the International Organization for Standardization ("ISO") and the United States Pharmacopoeia Convention, Inc.
We are also subject to various other federal, state, non-governmental, and local agency rules and regulations, including among others: U.S. federal anti-bribery laws; Federal Trade Commission regulation of advertising and marketing of consumer goods; consumer product safety requirements; U.S. export and import laws and trade, customs and tariff policies; state and federal privacy laws and regulations; laws requiring certain pharmaceutical manufacturers to track and report payments to physicians and teaching hospitals; and non-governmental standard-setting organizations such as the International Organization for Standardization ("ISO") and the United States Pharmacopoeia Convention, Inc.
These filings are also available to the public at www.sec.gov . 14 Perrigo Company plc - Item 1A Risk Factors ITEM 1A.
These filings are also available to the public at www.sec.gov . 13 Perrigo Company plc - Item 1A Risk Factors ITEM 1A.
Pillar Two legislation has been enacted or substantively enacted in many of the jurisdictions in which we operate. We are in compliance with the OECD’s Pillar Two framework. After a comprehensive assessment, we have determined that there is no material impact on our financial results as a result of these regulations.
Pillar Two legislation has been enacted or substantively enacted in many of the jurisdictions in which we operate. We are in compliance with the OECD’s Pillar Two framework. After a comprehensive assessment, we have determined that there is no material impact on our financial results as a result of the implementation of the Pillar Two framework to date.
If we are unable to obtain necessary quotas for List I chemicals, we risk having delayed product launches or failing to meet commercial supply obligations. • In 2023, the European Parliament voted on a proposal to extend the EU's Medical Device Regulation ("MDR") transition periods until 2027-2028, together with an extended validity of existing medical device certificates and the possibility to sell off existing medical device products until end of shelf-life.
If we are unable to obtain necessary quotas for List I chemicals, we risk having delayed product launches or failing to meet commercial supply obligations. 17 Perrigo Company plc - Item 1A Risk Factors • In 2023, the European Parliament voted on a proposal to extend the EU's MDR transition periods until 2027-2028, together with an extended validity of existing medical device certificates and the possibility to sell off existing medical device products until end of shelf-life.
Damage or disruption to our collective supply or distribution capabilities resulting from pandemics and other health crises, including government 20 Perrigo Company plc - Item 1A Risk Factors responses thereto, labor shortages, armed hostilities, border closures, weather conditions, freight carrier availability, any potential effects of climate change, natural disasters, strikes or other labor unrest or other reasons could impair our ability to source inputs or ship, sell or timely deliver our products.
Damage or disruption to our collective supply or distribution capabilities resulting from pandemics and other health crises, including government responses thereto, labor shortages, armed hostilities, border closures, weather conditions, freight carrier availability, any potential effects of climate change, natural disasters, strikes or other labor unrest or other reasons could impair our ability to manufacture, source inputs, ship, sell or timely deliver our products.
Our website address is www.perrigo.com , where we make available free of charge our reports on Forms 10-K, 10-Q and 8-K, including any amendments to these reports, as soon as reasonably practicable after they are electronically filed with or furnished to the U.S. Securities and Exchange Commission ("SEC").
We make available free of charge through our website our reports on Forms 10-K, 10-Q and 8-K, including any amendments to these reports, as soon as reasonably practicable after they are electronically filed with or furnished to the U.S. Securities and Exchange Commission ("SEC").
The risk of such impacts would be increased by continued consolidation in the sector in which our customers operate. Refer to Item 1. Business - Significant Customers .
The risk of such impacts would be increased by continued consolidation in the sector in which our customers operate. Refer to
This focus could lead to new requirements and restrictions in the coming years across all product categories. • U.S. law encourages generic competition by providing eligibility for first generic marketing exclusivity if certain conditions are met.
This focus could lead to new requirements and restrictions in the coming years across all product categories. 16 Perrigo Company plc - Item 1A Risk Factors • U.S. law encourages generic competition by providing eligibility for first generic marketing exclusivity if certain conditions are met.
In addition, an issue with one of our products could negatively affect the reputation of other products, potentially hurting our financial results. 19 Perrigo Company plc - Item 1A Risk Factors • Negative social media posts or comments about us, store brands or generic pharmaceuticals, or our products could damage our reputation and adversely affect our business.
In addition, an issue with one of our products could negatively affect the reputation of other products, potentially hurting our financial results. • Negative social media posts or comments about us, store brands or generic pharmaceuticals, or our products could damage our reputation and adversely affect our business.
Disruption of our supply chain, including as a result of the pandemics, global health crises, or wars or other civil unrest, including the war in Ukraine, or in the Middle East, could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Disruption of our supply chain, including as a result of pandemics, global health crises, wars or other civil unrest, including the war in Ukraine, or in the Middle East, could have a material adverse effect on our business, financial condition, results of operations and cash flows. Our ability to manufacture, deliver and sell our products is critical to our success.
Litigation and Insurance Risks • We are or may become involved in lawsuits and may experience unfavorable outcomes of such proceedings. • Increased scrutiny on pricing practices and competition, including antitrust enforcement activity by government agencies and class action litigation, may have an adverse impact on our business and operating results, which could be material. • Third-party patents and other intellectual property rights may limit our ability to bring new products to market and may subject us to potential legal liability, which could have a material adverse effect on our business and operating results. • The success of certain of our products depends on the effectiveness of measures we take to protect our intellectual property rights and patents. • Our ability to achieve operating results in line with published guidance is inherently subject to numerous risks and other factors beyond our control.
Litigation and Insurance Risks • We are and may become involved in lawsuits and may experience unfavorable outcomes of such proceedings. • Increased scrutiny on pricing practices and competition, including antitrust enforcement activity by government agencies and class action litigation, may have an adverse impact on our business and operating results, which could be material. • Third-party patents and other intellectual property rights may limit our ability to bring new products to market and may subject us to potential legal liability, which could have a material adverse effect on our business and operating results. • The success of certain of our products depends on the effectiveness of measures we take to protect our intellectual property rights and patents. • Significant increases in the cost or decreases in the availability of the insurance we maintain could adversely impact our operating results and financial condition.
In response to the FDA's evolving regulatory expectations on infant formula and observations at our facilities, we shortened our production campaigns to perform more frequent major cleanings, implemented enhanced product testing and quality procedures, adopted new manufacturing protocols, and made additional infrastructure investments.
In response to the FDA's evolving regulatory expectations on infant formula and observations at our facilities, we shortened our production campaigns to perform more frequent major cleanings, implemented enhanced product testing and quality procedures, adopted new manufacturing protocols, and made additional infrastructure investments. These measures have increased costs and reduced production volumes, and we expect higher compliance costs to continue.
If we are granted generic exclusivity, the exclusivity may be shared with other 17 Perrigo Company plc - Item 1A Risk Factors companies; or we may forfeit 180-day exclusivity if we fail to obtain regulatory approval and begin marketing within the statutory requirements.
If we are granted generic exclusivity, the exclusivity may be shared with other companies; or we may forfeit 180-day exclusivity if we fail to obtain regulatory approval and begin marketing within the statutory requirements.
Although there has not been any material impact on operations and we believe we have a strong mitigation plan in place, the conflict in the Middle East remains active and fluid and we could experience disruptions to our API supply.
As a precaution, Perrigo has engaged alternate suppliers to help minimize a potential supply disruption. Although there has not been any material impact on operations and we believe we have a strong mitigation plan in place, the conflict in the Middle East remains active and fluid and we could experience disruptions to our API supply.
If governments enhance regulations on the infant formula industry through actions such as requiring additional testing or compulsory batch-by-batch inspection, or impose additional requirements on manufacturing practices, our sales and operating margins in this category could be adversely affected as it is costly to comply with such new regulations or requirements, and to develop compliant products and processes for our infant formula products.
As governments impose new or more stringent regulations on the infant formula industry such as requiring additional testing, or compulsory batch-by-batch inspection, or revised manufacturing practice standards, our sales and operating margins in this category have been and could in the future be adversely affected as it is costly to comply with such new regulations or requirements, and to develop compliant products and processes for our infant formula products.
Item 7 , in response to the warning letter from the FDA in August 2023 and additional inspection observations at our Wisconsin infant formula facility, we have implemented new protocols and made additional infrastructure investments to address these observations.
Item 7 Management's Discussion and Analysis of Financial Condition and Results of Operations , in response to the warning letter from the FDA in August 2023 and additional inspection observations at our Wisconsin infant formula facility, we have implemented new protocols and made additional infrastructure investments to address these observations and expect to continue to make such changes.
Additionally, the conflict in the Middle East could impact our supply of API. Israel is a global technology research and development center that plays a critical role to the global API market, as a number of key suppliers are located within Israel. Perrigo sources some raw materials and finished goods from suppliers in Israel for certain self-care products, including Omeprazole.
Israel is a global technology research and development center that plays a critical role to the global API market, as a number of key suppliers are located within Israel. Perrigo sources raw materials and finished goods from suppliers in Israel for certain self-care products, including Omeprazole. There is potential for disruption as it relates to in-country logistics, including freight.
In some markets in the EU and outside the U.S., the government provides healthcare at low direct cost to consumers and regulates pharmaceutical prices or patient reimbursement levels to control costs for the government-sponsored healthcare system.
In the U.S., government programs such as Medicare and Medicaid, as well as private insurers, have been focused on cost containment. In some markets in the EU and outside the U.S., the government provides healthcare at low direct cost to consumers and regulates pharmaceutical prices or patient reimbursement levels to control costs for the government-sponsored healthcare system.
Failure to take adequate steps to reduce the likelihood or mitigate the potential impact of any of these events, or to effectively manage such events if they occur, particularly when a commodity or raw material is sourced from or a product is manufactured at a single location, could adversely affect our business, financial condition, results of operations and cash flows and require additional resources to restore our supply chain.
Failure to take adequate steps to reduce the likelihood or mitigate the potential impact of any of these events, or to effectively manage such events if they occur, particularly when a commodity or raw material is sourced from or a product is manufactured at a single location, could adversely affect our business, financial condition, results of operations and cash flows and require additional resources to restore our supply chain. 19 Perrigo Company plc - Item 1A Risk Factors As the war in Ukraine continues, supply chain disruptions in specific categories such as oil, agricultural and paper based commodities continue to lead to inflationary pressures in those areas.
With this decision the European Parliament took into account that there is currently a shortage in the number of Notified Bodies authorized to carry out conformity assessments required under MDR. • Increased scrutiny of product classifications by government agencies can result in investigations and prosecutions, which carry the risk of significant civil and criminal penalties, including but not limited to, debarment from government business and prohibition to continue the business. 18 Perrigo Company plc - Item 1A Risk Factors Limitations on reimbursement, continuing healthcare reforms, and changes to reimbursement methods in the United States and other countries may have an adverse effect on our financial condition and operating results.
With this decision the European Parliament took into account that there is currently a shortage in the number of Notified Bodies authorized to carry out conformity assessments required under MDR. • Increased scrutiny of product classifications by government agencies can result in investigations and prosecutions, which carry the risk of significant civil and criminal penalties, including but not limited to, debarment from government business and prohibition to continue the business.
AVAILABLE INFORMATION Our principal executive offices are located at The Sharp Building, Hogan Place, Dublin 2, D02 TY74, and our North American base of operations is located at 430 Monroe Avenue NW, Grand Rapids, Michigan 49503. Our telephone number is +353 1 7094000.
We are not anticipating the remaining provisions of the OBBBA to have a material effect on our consolidated financial statements. AVAILABLE INFORMATION Our principal executive offices are located at The Sharp Building, Hogan Place, Dublin 2, D02 TY74, and our North American base of operations is located at 430 Monroe Avenue NW, Grand Rapids, Michigan 49503.
We commit substantial effort, funds and other resources to these various collaborations. There is a risk that our investments in these collaborative arrangements will not generate the anticipated financial returns.
We have entered into strategic alliances with partners and suppliers to develop, manufacture, market and/or distribute certain products, or components of our products in various markets. We commit substantial effort, funds and other resources to these various collaborations. There is a risk that our investments in these collaborative arrangements will not generate the anticipated financial returns.
We believe that our existing global tax strategies will adequately address any necessary adjustments to comply with Pillar Two without significantly affecting our effective tax rate or overall financial position. We will continue to monitor regulatory developments to ensure ongoing compliance, but we do not anticipate any adverse effects on our operations or profitability due to these regulations.
We believe that our existing global tax strategies will adequately address any necessary adjustments to comply with Pillar Two without significantly affecting our effective tax rate or overall financial position.
If the FDA or comparable regulatory authority becomes aware of new safety information about any of our products, these authorities may require further inspection, enhancement to manufacturing controls, labeling changes, additional testing requirements, restrictions of indicated uses or marketing, post-approval studies, post-marketing surveillance or product withdrawal or recall.
If the FDA identifies or becomes aware of new safety information related to any of our products, it may require a range of actions, including additional inspections, enhancements to manufacturing controls, labeling modifications, additional testing, restrictions on indicated uses or marketing, post-approval studies, post-marketing surveillance, or product withdrawal or recall.
Any such reassessment could lead to OTC products reverting to prescription. For example, as described in Item 1. Business - Government Regulation and Pricing , Irish regulators are undertaking a formal review of non-prescription codeine products, which could result in the reclassification of codeine to prescription only after a brief transition period. A final opinion is expected in 2025.
For example, Irish regulators are undertaking a formal review of non-prescription codeine products, which could result in the reclassification of codeine to prescription only after a brief transition period. A final opinion is expected in 2026. Sales of products containing OTC codeine in Ireland were approximately $24 million in 2025.
If regulatory agencies fail to approve Rx-to-OTC switches in new product categories or reassess the terms of existing OTC classifications, our growth prospects and product mix would be impaired. Further, regulatory agencies may reassess the terms of OTC classification if they perceive a shift in the previously assessed benefit/risk profile.
If such measures are not successful, product withdrawal may be required. • Rx-to-OTC switches are part of our future growth. If regulatory agencies fail to approve Rx-to-OTC switches in new product categories or reassess the terms of existing OTC classifications, our growth prospects and product mix would be impaired.
("USP"). Compliance with the laws and regulations regarding the manufacture and sale of our current products and the discovery, development, and introduction of new products requires substantial effort, expense and capital investment. Regulation Outside the U.S.
("USP"). Compliance with the laws and regulations regarding the manufacture and sale of our current products and the discovery, development, and introduction of new products requires substantial effort, expense and capital investment. In the U.S., government healthcare programs such as Medicare and Medicaid, are important third-party payers for patients treated with our products.
Strategic Risks • We may not realize the benefits of business acquisitions, divestitures, and other strategic transactions, which could have a material adverse effect on our operating results. • We have acquired significant assets that could become impaired or subject us to losses and may result in an adverse impact on our results of operations, which could be material. • There can be no assurance that our business strategy and related strategic initiatives, including restructurings, will be executed effectively or achieve their intended effects. • The synergies and benefits expected from acquiring HRA Pharma and Gateway may not be realized in the amounts anticipated or at all and integrating HRA Pharma and Gateway's business may be more difficult, time consuming or costly than expected. • Failure to effectively monitor and respond to ESG matters, including our ability to set and meet reasonable goals related to climate change and sustainability efforts, may negatively affect our business and operations. • If we are unable to maintain effective internal control over financial reporting, investors could lose confidence in the accuracy and completeness of our financial reports and the market price of shares could be adversely affected. 15 Perrigo Company plc - Item 1A Risk Factors Global Risks • Our business, financial condition, and results of operations are subject to risks arising from the international scope of our operations. • We operate in jurisdictions that could be affected by economic and geopolitical instability, which could have a material adverse effect on our business. • The international scope of our business exposes us to risks associated with foreign exchange rates.
Strategic Risks • We may not realize the benefits of business acquisitions, divestitures, and other strategic transactions, which could have a material adverse effect on our operating results. • We have acquired significant assets that could become impaired or subject us to losses and may result in an adverse impact on our results of operations, which could be material. • There can be no assurance that our business strategy and related strategic initiatives, including restructurings, will be executed effectively or achieve their intended effects. • Failure to effectively monitor our strategies, initiatives and risks related to environmental, social, sustainability and governance matters, as well as any actual or perceived inability to satisfy the evolving and diverging requirements and expectations of our investors, customers, regulators, employees, suppliers and other stakeholders with respect to such matters may negatively affect our business and operations. 14 Perrigo Company plc - Item 1A Risk Factors • If we are unable to maintain effective internal control over financial reporting, investors could lose confidence in the accuracy and completeness of our financial reports and the market price of shares could be adversely affected.
Our manufacturing operations are concentrated in a few locations. Refer to Item 1. Business - Manufacturing and Distribution for more information. A significant disruption at one or more of these facilities, whether due to fire, natural disaster, power loss, intentional acts of vandalism, climate change, war, terrorism, insufficient quality, or pandemic could materially and adversely affect our business.
A significant disruption at one or more of these facilities, whether due to fire, natural disaster, power loss, intentional acts of vandalism, climate change, war, terrorism, insufficient quality, or pandemic could materially and adversely affect our business. Our business could be negatively affected by the performance of our collaboration partners and suppliers, and any such adverse impact could be material.
European Union ("EU") In the EU, as well as many other locations around the world, the manufacture and sale of medicinal products are regulated in a manner substantially similar to that of the U.S. requirements, which generally prohibit the handling, manufacture, marketing, and importation of any medicinal product unless it is properly registered in accordance with applicable law.
Other regulatory agencies, organizations and legislation that may impact our business include, but are not limited to privacy regulations, transparency laws, anti-bribery laws, and rules and regulations on infant formula. 11 Perrigo Company plc - Item 1 Business European Union ("EU") Regulation In the EU, as well as many other locations around the world, the manufacture and sale of medicinal products are subject to regulatory requirements similar to U.S. requirements, which generally prohibit the handling, manufacture, marketing, and importation of any medicinal product unless it is properly registered in accordance with applicable law.
Contrary to medicines, biocides are not exempted from chemical legislation such as the Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals No. 1907/2006 and the Regulation on Classification, Labelling and Packaging Regulation of substances and mixtures EC No. 1272/2008.
Biocides: Biocides in the EU market must comply with Regulation (EU) No. 528/2012, Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (EC) No. 1907/2006, and the Regulation on Classification, Labelling and Packaging Regulation of Substances and Mixtures (EC) No. 1272/2008.
Sales of products containing codeine in Ireland were approximately $21 million in 2024. Moreover, a reclassification by Ireland could lead to reviews in other jurisdictions as well. • Our infant formula products may be subject to barriers or sanctions imposed by countries or international organizations limiting international trade and dictating the content of such products.
Moreover, a reclassification by Ireland could lead to reviews in other jurisdictions as well. • Our infant formula products may be subject to barriers or sanctions that limit international trade or dictate product composition.
As a result, we have been experiencing increased costs and lower production volumes and expect higher compliance costs moving forward. • The regulation of List I chemicals complicate our supply chain, and adverse regulatory actions may result in temporary or permanent interruption of distribution of our products, withdrawal of our products from the market, or other penalties.
Together, these measures may introduce new compliance and regulatory obligations and may affect competitive dynamics in the U.S. market. • The regulation of List I chemicals complicate our supply chain, and adverse regulatory actions may result in temporary or permanent interruption of distribution of our products, withdrawal of our products from the market, or other penalties.
All medical devices will need to be approved under the MDR with transition periods until 2027-28, and the possibility to sell off existing medical device products until end of shelf-life. Dietary Supplements Dietary supplements are subject to several regulations that inform the selection of ingredient levels and how products can be described on packaging and in advertising.
Dietary Supplements: Dietary supplements are subject to several regulations that inform the selection of ingredient levels and how products can be described on packaging and in advertising.
While all sites have returned to reliable, quality-assured production , we incurred certain extraordinary costs associated with the remediation and enhancement actions and expect higher ongoing operating costs at our infant formula manufacturing sites moving forward.
While all sites have returned to reliable, quality-assured production , we incurred certain extraordinary costs associated with the remediation and 18 Perrigo Company plc - Item 1A Risk Factors enhancement actions, experienced increased production costs and reduced production volumes, and expect higher compliance costs to continue.
We develop and manufacture products and market third-party manufactured products in regions outside the U.S., primarily Europe, Canada, and Australia, each of which has its own regulatory environment. Other regulatory agencies, organizations and legislation that may impact our business include, but are not limited to privacy regulations, transparency laws, anti-bribery laws, and rules and regulations on infant formula.
Regulation Outside the U.S. We develop and manufacture products and market third-party manufactured products in regions outside the U.S., primarily Europe, Canada, and Australia, each of which has its own regulatory environment.
Future supply chain disruptions and inflationary pressures from the continuation of the conflicts between Russia and Ukraine, and escalating conflicts in the Middle East and neighboring regions, are uncertain. A disruption at any of our main manufacturing facilities could have a material adverse effect on our business, financial position, and results of operations.
Future supply chain disruptions and inflationary pressures from the continuation of the conflicts between Russia and Ukraine, and escalating conflicts in the Middle East and neighboring regions, are uncertain. Given the international scope of our operations, such effects of ongoing wars and armed conflicts, and others we cannot anticipate, could adversely affect our business, business opportunities, operations, and financial results.
This regulation requires manufacturers to prepare a product safety report prior to placing a cosmetic product in the market. In addition, for each cosmetic product placed in the market, a “responsible person” must be designated to oversee compliance with the regulation’s reporting requirements.
Cosmetics: Cosmetic products in the EU market are subject to several regulations that require manufacturers to prepare a product safety report prior to placing a cosmetic product in the market and to designate a “responsible person” to oversee compliance with the regulation’s reporting requirements.
The effects of public health outbreaks, including pandemics and epidemics, and related public and governmental actions could have a material adverse impact on our operations and our business and financial condition in the future. As the COVID-19 pandemic demonstrated, the global economy and the self-care markets in which we compete are susceptible to impacts from public health crises.
As the COVID-19 pandemic demonstrated, the global economy and the self-care markets in which we compete are susceptible to impacts from public health crises. Future public health incidents could materially impact demand, operations, supply chains, and liquidity, depending on severity, duration, and mitigation effectiveness. The magnitude of any such adverse impacts are not determinable.
Item 1A. Risk Factors - Operational Risks for related risks. United States Regulation U.S. Food and Drug Administration Under the Federal Food, Drug and Cosmetic Act, as amended ("FDCA") the FDA has jurisdiction over OTC drug products, Active Pharmaceutical Ingredients ("API"), medical devices, cosmetics, and foods including dietary supplements and infant formula products.
United States Regulation Our products are subject to regulation by one or more U.S. agencies, including the U.S. FDA. The FDA has regulatory authority over OTC drug products, active pharmaceutical ingredients ("API"), medical devices, cosmetics, and foods, including dietary supplements and infant formula.
As the war in Ukraine continues, supply chain disruptions in specific categories such as oil, agricultural and paper based commodities continue to lead to inflationary pressures in those areas. Any escalation of the conflict could lead to wider disruptions in our supply chain or have larger macroeconomic effects.
Any escalation of the conflict could lead to wider disruptions in our supply chain or have larger macroeconomic effects. Additionally, the conflict in the Middle East could impact our supply of API.
The FDA conducts periodic compliance inspections of our facilities, quality management system and manufacturing processes.
The FDA periodically inspects our facilities and reviews our quality management systems and manufacturing processes for compliance with applicable laws and regulations.
The method of assessing conformity varies depending on the class of the product, but normally involves a combination of self-assessment by the manufacturer and a third-party assessment by a Notified Body, an organization accredited by a member state under the EU's Medical Device Regulation ("MDR").
Market access depends on completion of a conformity assessment, which varies by product type and typically includes manufacturer self-assessment and a third-party assessment by a Notified Body (an organization accredited by a member state under the EU's MDR). All devices must transition to MDR approvals by 2027–2028, with sell-off of existing products permitted until end of shelf life.
Commission Regulation EU No. 655/2013 establishes the common criteria and justification for claims to be used in the packaging and advertising of cosmetics products. Biocides Biocides in the EU market must comply with Regulation EU No. 528/2012 ("EU BPR") overseen by the European Chemicals Agency.
Such regulations also provide a common criteria and justification for claims to be used in the packaging and advertising of cosmetics products.
In addition, the FDCA requires infant formula manufacturers to test product composition and safety during production and shelf-life; to keep records on production, testing, and distribution of each batch of infant formula; to use cGMP and quality control procedures; and to maintain records of all complaints and adverse events, some of which may reveal the possible existence of a health hazard.
The FDA requires infant formula manufacturers to test product composition and safety during production and shelf-life, and to maintain detailed production, testing, distribution, and complaint records. The FDA inspects our infant formula manufacturing facilities and collects and analyzes samples of our infant formula. In March 2025, the U.S.
Health ministries are authorized to cancel the registration of a product if it is found to be harmful or ineffective or if it is manufactured or marketed other than in accordance with registration conditions. Medical Devices The EU has enacted into law numerous directives and adopted many harmonizing standards pertaining to a wide range of industrial products, including medical devices.
Obtaining approvals across EU member states can be complex, and health authorities may suspend or cancel registrations if a product is found harmful or ineffective, or if it is manufactured or marketed contrary to the conditions of registration.
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The FDA’s jurisdiction can include the sourcing, manufacturing, testing, labeling, packaging, storage, distribution and marketing of these products. We are committed to consistently providing our customers with high quality products that adhere to FDA recommendations in industry guidance and meet the requirements of various regulations promulgated by the FDA.
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Item 1A. Risk Factors - Operational Risks for risks associated with our manufacturing facilities. OUR SUSTAINABILITY AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE (“ESG”) STRATEGY Sustainability We view sustainability as an opportunity to create long-term value for our business and stakeholders.
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OTC All of our drug products are manufactured, tested, packaged, stored, and distributed according to current Good Manufacturing Practice ("cGMP") regulations. The FDA performs periodic inspections and/or records audits to ensure that our facilities and quality systems remain in compliance with all appropriate regulations and agency expectations.
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Accordingly, we align our initiatives with established frameworks such as the Task Force on Climate-related Financial Disclosures ("TCFD"), the Sustainability Accounting Standards Board ("SASB"), and the Global Reporting Initiative ("GRI"). To facilitate progress, we establish measurable objectives and endeavor to provide transparent reporting on our progress.
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Specific regulations and laws that impact our business include, but are not limited to: • The FDCA gives authority to the FDA to oversee the safety of food, drugs, medical devices, cosmetics and other items.
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We believe this commitment helps position us to adapt to evolving expectations and regulatory requirements. Sustainability is governed through an intentional framework that integrates oversight at both the board and management levels. The Board of Directors maintains responsibility for overseeing all major enterprise risks, including ESG matters, with specific committees providing focused review of sustainability and climate-related risks.
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Following the 2012 enactment of the Food and Drug Administration Safety and Innovation Act, the FDCA incorporated, among other things, new user fee collection authority for prescription drugs.
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This structure is designed to ensure that sustainability considerations are embedded within Perrigo’s overall risk management and strategic direction. Management oversight is led by the Executive Leadership Team and the Vice President Global Ethics, Privacy & Sustainability, supported by dedicated sustainability professionals embedded across key business functions.
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Since that time, user fee authority has been extended to OTC drugs, generic drugs and biosimilars and to additional supply chain parties. • The FDCA is regularly modified by Congress in other ways, including modifying FDA’s authority regarding drug and device shortages and enhancing the FDA's inspection authority of the drug supply chain. • The FDA Reauthorization Act of 2017 created a pathway by which the FDA may, at the request of an applicant, designate a drug with “inadequate generic competition” as a Competitive Generic Therapy. • Public Health Service Act, as amended (PHS Act) The Public Health Service Act (PHSA) regulates biologics through Section 351, which outlines the requirements for the approval, licensing, and oversight of biological products.
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This cross-functional approach is designed to ensure that sustainability considerations are reflected in strategic decision-making, operational practices, and ongoing stakeholder engagement. Our sustainability strategy centers on four key priorities: Acting on Climate, People & Communities, Packaging and Responsible Sourcing. These areas guide our efforts to reduce our impact and create value for our stakeholders.
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API Third parties develop and manufacture APIs for use in certain of our pharmaceutical products that are sold in the U.S. and other global markets. API manufacturers typically submit a drug master file to the FDA that provides proprietary information related to the API manufacturing process.
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Acting on Climate: Mitigating the climate crisis requires ambitious goals and credible, science-based actions. Perrigo's goal is to reach net zero greenhouse gas emissions across our supply chain and operations by 2040.
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The FDA inspects the manufacturing facilities to assess compliance and the facilities and procedures must be compliant before API may be imported into the U.S.
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Our plan includes reducing our direct and indirect emissions by minimizing our production footprint, investing in renewable energy, redesigning products and packaging, and moving to electric vehicle fleets for our international business. People & Communities: We foster a culture of inclusivity and teamwork, both within Perrigo and in the communities we serve.
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Currently, API must also be associated to an active or approved FDA application in order to be imported into the U.S. unless it meets certain exemptions. 11 Perrigo Company plc - Item 1 Business Medical Devices We are subject to the Medical Device Amendments of 1976 to the FDCA and its subsequent amendments in the U.S.
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We have made progress in increasing representation at our board and executive levels, helping us better reflect the experiences of our consumers. Packaging: Better products and packaging help our consumers, the climate, and our planet. We are contributing to the circular economy by transitioning to reusable, recyclable, and compostable packaging, where possible.
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The regulations issued thereunder provide for regulation by the FDA of the design, manufacture and marketing of medical devices, including some of our products marketed under our oral care and OTC businesses. All of our current medical devices fall under Class I or Class II of the regulations.
Added
Our priorities include reducing packaging weight and innovating materials. Responsible Sourcing: We are committed to upholding human rights, ensuring fair working conditions, and protecting the environment in our supply chain. We demonstrate our commitment through rigorous monitoring programs.
Removed
These devices are also subject to other general controls established by the FDA, such as registration, listing, labeling, and reporting obligations. Infant Formula The FDA’s new unified Human Foods Program is responsible for the regulation of food safety, including infant formula.
Added
Our intention is to collaborate with suppliers who share our values and responsible practices to make a positive impact on our value chain. 8 Perrigo Company plc - Item 1 Business Environmental Matters Our facilities and operations are subject to various environmental laws and regulations relating to air emissions, wastewater discharges, solid and hazardous waste management activities, and the safety of our employees.
Removed
The Nutrition Center of Excellence ensures the nutritional adequacy and safety of infant formula through the Office of Nutrition & Food Labeling, and the Office of Critical Foods conducts infant formula pre-market review.
Added
We undergo periodic internal audits related to environmental, health, and safety requirements to maintain compliance with applicable laws and regulations in each jurisdiction where we operate. We also maintain regulatory registers of all applicable environmental, health and safety compliance obligations that we conduct periodic self-assessments against to determine our compliance status for each manufacturing site.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe believe these initiatives will reduce operating costs and/or enhance our net sales, operating margins, and earnings; however, certain of these initiatives require substantial costs during implementation, and there can be no assurance any of these initiatives will produce the anticipated benefits.
Biggest changeCertain of these initiatives require substantial management time and effort and costs during implementation, and there can be no assurance any of these initiatives will produce the anticipated benefits. Any increase in such costs or delay or failure to achieve the anticipated benefits could materially adversely affect our business, results of operations, liquidity, and financial condition.
In the case of divestitures, including the disposition of the Rare Disease Business and the separation of the Rx business, we may face difficulty in effectively transferring contracts, obligations, facilities, and personnel to the purchaser, while minimizing continued exposure to risks and liabilities of the divested business.
In the case of divestitures, including the disposition of the Rare Diseases Business and the separation of the Rx business, we may face difficulty in effectively transferring contracts, obligations, facilities, and personnel to the purchaser, while minimizing continued exposure to risks and liabilities of the divested business.
We manufacture, source raw materials, and sell our products in a number of countries. The percentage of our business outside the U.S. has been increasing. We are subject to risks associated with international manufacturing and sales, including changes in regulatory requirements. Refer to
We manufacture, source raw materials, and sell our products in a number of countries. The percentage of our business outside the U.S. has been increasing. We are subject to risks associated with international manufacturing and sales, including changes in regulatory requirements. Refer to Item 1. Business - Government Regulation and Pricing .
If we fail to maintain the adequacy of our internal controls, we may not be able to ensure that we can conclude on an ongoing basis that we have effective internal control over financial reporting. 25 Perrigo Company plc - Item 1A Risk Factors Global Risks Our business, financial condition, and results of operations are subject to risks arising from the international scope of our operations.
If we fail to maintain the adequacy of our internal controls, we may not be able to ensure that we can conclude on an ongoing basis that we have effective internal control over financial reporting. Global Risks Our business, financial condition, and results of operations are subject to risks arising from the international scope of our operations.
For example, after our acquisition of Gateway, in response to the FDA's evolving regulatory expectations on infant formula and observations at our facilities, we have shortened our production campaigns to perform more frequent major cleanings and implemented enhanced product testing and quality procedures, resulting in additional costs and lower production volumes of infant formula than previously anticipated.
For example, after our acquisition of Nestlé’s Gateway infant formula plant along with the U.S. and Canadian rights to the GoodStart ® infant formula brand and other related formula brands ("Gateway"), in response to the FDA's evolving regulatory expectations on infant formula and observations at our facilities, we have shortened our production campaigns to perform more frequent major cleanings and implemented enhanced product testing and quality procedures, resulting in increased production costs and reduced production volumes of infant formula than previously anticipated.
Note 9 for additional information related to our goodwill and intangible assets. 23 Perrigo Company plc - Item 1A Risk Factors There can be no assurance that our business strategy and related strategic initiatives, including restructurings, will be executed effectively or achieve their intended effects.
Note 10 for additional information related to our goodwill and intangible assets. There can be no assurance that our business strategy and related strategic initiatives, including restructurings, will be executed effectively or achieve their intended effects. Our success is dependent in large part on our ability to implement our One Perrigo strategy and business model successfully.
Although we believe these leadership transitions are in the best interest of our stakeholders, any change in executive management creates uncertainty.
These actions are intended to advance the Company’s multi-year Stabilize, Streamline and Strengthen plan and reflect the Company’s operational readiness. Although we believe these leadership transitions are in the best interest of our stakeholders, any change in executive management creates uncertainty.
While challenging and aspirational, we believe these goals are obtainable, however, any failure or perceived failure to achieve our sustainability goals or to act responsibly with respect to such matters may negatively impact our operations and/or financial condition.
Any 24 Perrigo Company plc - Item 1A Risk Factors failure or perceived failure to achieve our sustainability goals or to act responsibly with respect to such matters may negatively impact our operations and/or financial condition.
Any significant change in market conditions, estimates or judgments used to determine expected future cash flows that indicates a reduction in carrying value may give rise to impairment in the period that the change becomes known. Goodwill, indefinite-lived intangible asset, and definite-lived intangible asset impairments are recorded in Impairment charges on the Consolidated Statements of Operations.
Any significant change in market conditions, 23 Perrigo Company plc - Item 1A Risk Factors estimates or judgments used to determine expected future cash flows that indicates a reduction in carrying value may give rise to impairment in the period that the change becomes known.
Navigating varying expectations of policymakers and other stakeholders has inherent costs, and any failure to successfully navigate such expectations may expose us to negative publicity, shareholder activism, and litigation of other engagement from stakeholders with opposing views, as well as the potential for civil investigations and enforcement by federal governmental authorities.
Moreover, stakeholder expectations are not uniform on these matters and continue to diverge across different jurisdictions, and we may be unable to satisfy the varying expectations of all relevant policymakers and other stakeholders and any actual or perceived failure to successfully navigate such expectations may expose us to negative publicity, shareholder activism, litigation or other engagement from stakeholders, as well as the potential for investigations and enforcement by governmental authorities.
If we are unable to recognize and respond to such developments, or if our existing practices and procedures are not adequate to meet new and changing regulatory requirements, market standards or investor expectations, some of which may be conflicting, we may miss corporate opportunities, become subject to regulatory scrutiny, litigation or third-party claims, or incur costs to revise operations to meet new or revised standards.
If we are unable to adequately respond to such developments, including by adapting existing practices and procedures to changing requirements, some of which may be conflicting, we may miss corporate opportunities, become subject to regulatory or market scrutiny, and be exposed to legal reputational, operational and financial risks.
Regulatory developments and stakeholder expectations relating to ESG matters are rapidly changing. Concern over climate and other environmental and social topics has increased focus on the sustainability of practices and products in the markets we serve, and compliance with new laws and regulations regarding these ESG topics may result in increased costs and disruption to operations.
There has been increasing scrutiny over climate, corporate diversity and other environmental, social and sustainability topics in the markets we serve, resulting in, and among other responses, new and changing laws, regulations and policies regarding these topics that may result in increased costs and disruption to operations.
As of December 31, 2024, the net book value of our goodwill and intangible assets were $3.3 billion and $2.4 billion, respectively. In the past three years, we have recognized a total of $178.9 million in asset impairments, across all segments and asset categories. Refer to Item 8.
Goodwill, indefinite-lived intangible asset, and definite-lived intangible asset impairments are recorded in Impairment charges on the Consolidated Statements of Operations. As of December 31, 2025, the net book value of our goodwill and intangible assets were $2.1 billion and $2.4 billion, respectively.
While we monitor a broad range of ESG issues, there can be no assurance that we will manage such issues successfully, or that we will successfully meet the expectations of our stakeholders, consumers and employees.
We have set goals and commitments related to climate and other sustainability issues. Given the varied and evolving expectations of our stakeholders, there can be no assurance that such goals and commitments will align with the expectations of all relevant stakeholders.
In addition, in 2024 we launched Project Energize, a global investment and efficiency program to drive the next evolution of the Company's capabilities and organizational agility. We also continue to invest in other initiatives, including innovation, information systems and tools, and our people to drive consistent and sustainable results.
We continue to invest in initiatives, including innovation, information systems and tools, and our people to drive consistent and sustainable results. We believe these initiatives will reduce operating costs and/or enhance our net sales, operating margins, and earnings.
Removed
Item 1C. Cybersecurity . Management transition creates uncertainties, and any difficulties we experience in managing such transitions may negatively impact our business. We have experienced significant changes to our leadership team over the past several years. Patrick Lockwood-Taylor was appointed President, Chief Executive Officer and Board Member in 2023.
Added
Item 1C. Cybersecurity . Management transition and our ability to attract and retain key personnel create uncertainties which may negatively impact our business. Our success depends on attracting, developing, and retaining qualified leaders and other key employees.
Removed
In 2024, the Company appointed new leaders of its CSCA and CSCI segments with the appointments of Catherine "Triona" Schmelter as President Consumer Self-Care Americas and Roberto Khoury as President Consumer Self-Care International.
Added
Competition for skilled personnel and leaders within and outside of our industry is high, and we may be unable to hire or retain needed talent. We have experienced significant changes to our leadership team over the past several years.
Removed
We also appointed Charles Atkinson as our new General Counsel and Abbie Lennox as our Chief Science Officer and 22 Perrigo Company plc - Item 1A Risk Factors expanded our Chief Scientific Office, with Allison Ives tasked to head our new Disruptive Growth Team. Additionally, David Ball was appointed as Chief Brand and Digital Officer.
Added
Loss of key personnel, vacancies in critical roles, or organizational changes, including leadership transitions and succession planning, creates uncertainty and could disrupt operations and adversely affect our business, financial condition, or results of operations. 22 Perrigo Company plc - Item 1A Risk Factors During 2025, the Company undertook organizational changes to streamline its leadership structure and align the organization around global categories.
Removed
Moreover, changes in our Company as a result of management transition could have a disruptive impact on our ability to implement, or result in changes to, our strategy and could negatively impact our business, financial condition and results of operations.
Added
In connection with these changes, the Company discontinued the roles of Executive Vice President and President for each of the CSCI and CSCA segments. The Company appointed Roberto Khoury as Executive Vice President and Chief Commercial Officer, with responsibility for operating results for the CSCI and CSCA segments.
Removed
Our success is dependent in large part on our ability to implement our One Perrigo strategy and business model successfully. To drive our business model and improve financial performance, we are engaged in certain ongoing restructuring programs.
Added
Evolving labor market conditions including wage inflation, labor shortages, changes in immigration laws and policies, and preferences for remote or flexible work, may increase costs, constrain staffing, and reduce the effectiveness of our talent programs.
Removed
In late 2022, we initiated our Supply Chain Reinvention Program, designed to increase operational efficiency and improve our return on invested capital by, among other goals, reducing portfolio complexity, investing in advanced planning capabilities, diversifying sourcing, and optimizing our manufacturing assets and distribution models.
Added
During fiscal year 2025, we commenced a strategic review of our oral care business and infant formula business and began exploring a range of strategic alternatives for those businesses. There can be no assurance that these strategic reviews will result in any particular outcome or transaction, or as to the timing thereof.
Removed
Any increase in such costs or delay or failure to achieve the anticipated benefits could have a material adverse effect on our projected results. Various factors may impact our ability to implement our strategies and realize their anticipated benefits.
Added
In the past three years, we have recognized a total of $1,542.0 million in asset impairments, across all segments and asset categories. Indicators of impairment are difficult to predict, particularly in the pharmaceutical and medical device industries.
Removed
These factors include circumstances outside of our control such as increased competition, legal developments, government regulation, general economic conditions, increased operating costs or expenses and changes in industry trends or consumer preferences.
Added
Because goodwill and intangible assets represent a significant portion of our total assets, any impairment charge could have a material adverse effect on our financial condition and results of operations in the period recognized, and could adversely affect the market value of our common stock and/or our outstanding debt securities. Refer to Item 8.
Removed
In addition, implementing these changes will require a significant amount of management time and effort, which may disrupt our business or otherwise divert management’s attention from other aspects of our business, including our other strategic initiatives, possible organic or inorganic growth opportunities, and customer and vendor relationships.
Added
For example, the Company previously disclosed that it initiated a strategic review of its infant formula and oral care businesses to assess a full range of alternatives, and there are no assurances that any such alternatives may achieve its intended objective.
Removed
Any of the foregoing risks could materially adversely affect our business, results of operations, liquidity, and financial condition. The synergies and benefits expected from acquiring HRA Pharma and Gateway may not be realized in the amounts anticipated or at all and integrating HRA Pharma and Gateway's business may be more difficult, time consuming or costly than expected.
Added
During the first quarter of 2026, we have begun transitioning from a geographic segment reporting structure to a category-based segment view, enabling us to better align our financial disclosures and operational analysis with our product offerings and strategic priorities.
Removed
We may experience challenges integrating the Gateway business and managing our expanded operations, including the acquisition of HRA Pharma. Our ability to realize the benefits expected from the HRA Pharma and Gateway acquisitions will depend, in part, on our ability to successfully integrate the business, control costs and maintain growth.
Added
The change is being made to stay in alignment with the way our chief operating decision maker intends to make future operating decisions, allocate resources and manage the growth and profitability of the Company. The anticipated change is not expected to have any impact on the Company's historical consolidated financial position, results of operations, or cash flows.
Removed
Integrations can be complex and time consuming, and the integration may result in temporarily depressed sales while integration of supply chain and distribution channels take place. Any delays, additional unexpected costs, or other difficulties encountered in the integration process could have a material adverse effect on the Company’s revenues, expenses, operating results and/or financial condition.
Added
Failure to effectively monitor our strategies, initiatives, and risks related to environmental, social, sustainability and governance matters, as well as any actual or perceived inability to satisfy the evolving and diverging requirements and expectations of our investors, customers, regulators, employees, suppliers and other stakeholders with respect to such matters, may negatively affect our business and operations.
Removed
While the integration of HRA Pharma was completed during 2023, activities related to the integration of Gateway continued into 2024. Even if integration occurs successfully, we may not achieve projected synergies or level of anticipated sales growth in new products, brands, or geographic markets within the anticipated timeframe, or at all.
Added
Regulatory developments and stakeholder expectations relating to environmental, social, sustainability and governance matters are rapidly changing.
Removed
There are inherent uncertainties involved in identifying and assessing the profit potential, value, strengths, weaknesses, risks, and contingent and other liabilities of acquisitions, such as HRA Pharma and Gateway, some of which can be affected by risks and uncertainties relating to government regulations and oversight as well as changes in the business, the industry, competition, consumer trends or general economic conditions.
Added
For example, the European Union has adopted mandatory sustainability report and due diligence requirements under the Corporate Sustainability Reporting Directive (“CSRD”) and the Corporate Sustainability Due Diligence Directive ("CSDDD"). While certain jurisdictions in which we operate have adopted or proposed similar laws, regulations or policies, other jurisdictions have adopted or proposed diverging or conflicting laws, regulations or policies.
Removed
For instance, in response to the FDA's evolving regulatory expectations on infant formula, we have shortened our production campaigns to perform more frequent major cleanings and implemented enhanced product testing and quality procedures, resulting in additional costs and lower production volumes of infant formula. 24 Perrigo Company plc - Item 1A Risk Factors Failure to effectively monitor and respond to ESG matters, including our ability to set and meet reasonable goals related to climate change and sustainability efforts, may negatively affect our business and operations.
Added
Our actual or perceived inability to comply with all applicable law, regulation or policies, including on environmental, social, sustainability and governance matters, could increase our exposure to legal and reputational risks and have a material adverse effect on our business.
Removed
For example, The European Union’s Corporate Sustainability Reporting Directive (“CSRD”) significantly expands mandatory sustainability reporting in accordance with European Sustainability Reporting Standards (“ESRS”). While CSRD rules are prescriptive for the types of data to be reported, the standards to quantify and qualify such data are still evolving and uncertain.
Added
In addition, there are many factors, including factors outside of our control, that impact our ability to achieve any goals or commitments we set with respect to these matters.
Removed
However, it is likely to impose significant increased costs on us related to complying with our reporting obligations and increase risks of noncompliance with ESRS and the CSRD. We are monitoring the rules and regulations related to CSRD and anticipate to be included in the CSRD’s scope beginning in 2025, with the initial reporting expected in 2026.
Added
In 2025, the U.S government imposed new and additional tariffs on a significant number of countries and threatened to further increase the scope and amount of tariffs in the event of retaliatory countermeasures. The future of these current tariffs, and the possibility for new tariffs which could include ones specifically targeting pharmaceuticals, under which many of our U.S.
Removed
In March 2024, the SEC released its final rule on climate-related disclosures, which would have required the disclosure of certain climate-related risks and financial impacts, as well as GHG emissions. Following a number of legal challenges, the implementation of these rules has been stayed pending review by the U.S. Court of Appeals for the Eight Circuit.
Added
OTC self-care products may be classified, remains uncertain. In February 2026, the U.S. Supreme Court struck down certain tariffs previously imposed by the U.S. government, but the U.S. government has expressed an intention to reinstate and in certain cases increase tariffs in response.
Removed
In light of such pending litigation and the change in presidential administration, it is uncertain if and when such rules would take effect or in what form. Moreover, the standards by which ESG matters are measured are rapidly evolving, and certain areas are subject to assumptions that could change over time.
Added
The timing, scope, duration, and potential exemptions associated with these new tariffs remain subject to further administrative action and clarification. The U.S. Department of Commerce initiated an investigation under Section 232 of the Trade Expansion Act of 1962, as amended, to determine the effects of importing pharmaceuticals and pharmaceutical ingredients on national security.
Removed
Stakeholder expectations are not uniform, and both opponents and proponents of various ESG-related matters have increasingly resulted in a range of activism and action to advocate for their positions.
Added
While no specific action has been taken to date, this investigation may lead to the imposition of tariffs on pharmaceutical imports, consistent with the current U.S. administration's stated policy objective of reshoring pharmaceutical manufacturing to the United States.
Removed
As a global organization, we have set goals to address the impact of our operations on climate change and related environmental and social issues. These targets include reducing carbon emissions and water usage as well as becoming fully reliant on renewable energy sources. Refer to Item 1. Business - Environmental .
Added
Through fiscal year 2025, these new tariffs and trade policies have had a significant impact on our results of operations and the impact of these tariffs has materially increased the cost of goods for our products and materials sourced from other countries, particularly China.
Added
Given the recent invalidation of prior tariffs and the imposition of new temporary tariffs, our cost structure remains subject to rapid and unpredictable change, and we expect continued material impacts on our U.S. business.
Added
The Supreme Court did not determine whether duties paid under the invalidated tariff regime must be refunded, further contributing to uncertainty regarding historical and future cost of goods sold.
Added
As a result of these dynamic conditions and uncertainties, we have modified, and may further modify, our operations and strategic initiatives, including by adjusting our investment priorities, reallocating resources, or delaying specific initiatives, such as deferring capital expenditures on the Nutrition Network Optimization project, initiating an enterprise-wide operational enhancement program, and seeking further working capital improvements.
Added
If we are unable to mitigate these increased costs through supply chain adjustments, pricing strategies or other measures, these costs, as well as the costs incurred in implementing these measures, could have a material adverse impact on our results of operations and cash flows from operations.
Added
We cannot predict the extent to which other countries will impose duties, tariffs, taxes or other similar restrictions upon the import or export of goods and materials in the future, nor can we predict future U.S. trade policy, including the potential continued regulatory forbearance allowing imported infant formulas in the United States, or the terms of any renegotiated trade agreements and their impact on our business. 25 Perrigo Company plc - Item 1A Risk Factors Similarly, we cannot predict which of our products will be impacted by tariffs or eligible for exceptions under existing or future trade agreements.
Added
In addition, in response to tariffs announced by the United States, other countries have implemented, and may implement additional, retaliatory tariffs on U.S. goods. Political tensions as a result of trade policies could reduce trade volume, investment, technology exchanges, and other economic activities between major international economies.
Added
In addition, elevated tariffs or trade restrictions, or the expectation of such changes, could increase inflation or unemployment and reduce consumers' disposable income and spending.
Added
The occurrence of any of the foregoing could result in a material adverse effect on global economic conditions and the stability of global financial markets, which could in turn have a material adverse impact on our business and financial condition. Additionally, we are subject to periodic reviews and audits by governmental authorities responsible for administering import and export regulations.
Added
To the extent that we are unable to successfully defend against an audit or review, we may be required to pay assessments, penalties, and increased duties. Certain of our facilities operate in a special purpose sub-zone established by the U.S.
Added
Department of Commerce Foreign Trade Zone Board, which allows us certain tax advantages on products and raw materials shipped through these facilities. If the Foreign Trade Zone Board were to revoke the sub-zone designation or limit our use, we could be subject to increased duties.
Added
Although we believe that we conduct our business in compliance with applicable anti-corruption, anti-bribery and economic sanctions laws, if we are found to not be in compliance with such laws or other anti-corruption laws, we could be subject to governmental investigations, legal or regulatory proceedings, substantial fines, and/or other legal or equitable penalties.
Added
This risk increases in locations outside of the U.S., particularly in locations that have not previously had to comply with the Foreign Corrupt Practices Act ("FCPA"), U.K. Bribery Act 2010, Irish Criminal Justice (Corruption Offenses) Act 2018, and similar laws.
Added
We operate in jurisdictions that could be affected by economic and geopolitical instability, which could have a material adverse effect on our business. Our operations and supply partners could be affected by economic or political instability, embargoes, military hostilities, unstable governments and legal systems, inter-governmental disputes, travel restrictions, terrorist acts, and other armed conflicts.
Added
The global nature of our business involves the following risks, among others: • The U.S. Department of State and other governments have at times issued advisories regarding travel to certain countries in which we do business, causing regulatory agencies to curtail or prohibit their inspectors from traveling to inspect facilities.
Added
If these inspectors are unable to inspect our facilities, the regulatory agencies could withhold approval for new products intended to be produced at those facilities. • As a result of the exit of the U.K. from the E.U. (“Brexit”), which occurred in 2020, we continue to experience uncertainty surrounding certain of our businesses.
Added
While the E.U. and U.K. ratified a Trade and Cooperation Agreement (the “TCA”) that sets forth a framework for cooperation between the E.U. and U.K., including the mutual recognition of GMP inspections of manufacturing facilities for medicinal products, it does not contain wholesale mutual recognition of pharmaceutical regulations and product standards, and the E.U. and the U.K. continue to amend legislation and regulations post-Brexit.
Added
We continue to monitor for divergence between E.U. and U.K. regulations that could negatively impact our supply chain operations or other product development or sales operations. • Moreover, financial volatility and geopolitical instability outside the U.S. may impact our operations or affect global markets.
Added
Refer to “ Risk Factors—Operational Risks —Disruption of our supply chain, including as a result of pandemics, global health crises, or wars or other civil unrest, including war in Ukraine, or in the Middle East, could have a material adverse effect on our business, financial condition, results of operations and cash flows.” The international scope of our business exposes us to risks associated with foreign exchange rates.
Added
We report our financial results in U.S. dollars. However, a significant portion of our revenues, expenses, assets, indebtedness and other liabilities are denominated in foreign currencies. These currencies include, among others, the Euro, British pound, Canadian dollar, Swedish Krona, Chinese Yuan, Danish Krone, and Polish Zloty.
Added
Fluctuations in currency exchange rates, including as a result of inflation, central bank monetary policies, currency controls or other currency exchange restrictions have had, and could continue to have, an adverse impact on our financial performance. We may seek to mitigate the risk of such impacts through hedging, but such hedging activities may be costly and may not be effective.
Added
In addition, emerging market economies in which we operate may be particularly vulnerable to the impact of rising interest rates, inflationary pressures, weaker oil and other commodity prices, and large external deficits.
Added
Risks in one country can limit our opportunities for portfolio growth and negatively affect our operations in another country or 26 Perrigo Company plc - Item 1A Risk Factors countries. Such conditions or developments could have an adverse impact on our operations. In addition, we may be exposed to credit risks in some of those markets.
Added
Litigation and Insurance Risks We are and may become involved in lawsuits and may experience unfavorable outcomes of such proceedings.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeOur primary facilities by geographic area were as follows at December 31, 2024: Country Number of Facilities Segment(s) Supported Ireland 1 CSCA, CSCI United States 40 CSCA, CSCI France 6 CSCI Belgium 3 CSCI China 4 CSCA United Kingdom 4 CSCI Germany 3 CSCI Switzerland 3 CSCI Austria 3 CSCI Greece 2 CSCI Spain 2 CSCI We believe that our production facilities are adequate to support the business, and our property and equipment are well maintained.
Biggest changeOur primary facilities by geographic area were as follows at December 31, 2025: Country Number of Facilities Segment(s) Supported Ireland 1 CSCA, CSCI United States 40 CSCA, CSCI France 5 CSCI China 4 CSCA United Kingdom 3 CSCI Belgium 2 CSCI Germany 2 CSCI Greece 2 CSCI Spain 2 CSCI Sweden 2 CSCI We believe that our production facilities are adequate to support the business, and our property and equipment are well maintained.
ITEM 2. PROPERTIES Our world headquarters is located in Dublin, Ireland, and our North American base of operations is located in Grand Rapids, Michigan. We manufacture products at 16 worldwide locations and have R&D, logistics, and office support facilities in many of the regions in which we operate. We own approximately 80% of our facilities and lease the remainder.
ITEM 2. PROPERTIES Our world headquarters is located in Dublin, Ireland, and our North American base of operations is located in Grand Rapids, Michigan. We manufacture products at 14 worldwide locations and have R&D, logistics, and office support facilities in many of the regions in which we operate. We own approximately 85% of our facilities and lease the remainder.
Our manufacturing plants are suitable for their intended purposes and have capacities for current and near term projected needs of our existing products. 34 Perrigo Company plc - Item 2 ITEM 3. LEGAL PROCEEDINGS Information regarding our current legal proceedings is presented in Item 8. Note 19 .
Our manufacturing plants are suitable for their intended purposes and have capacities for current and near-term projected needs of our existing products. ITEM 3. LEGAL PROCEEDINGS Information regarding our current legal proceedings is presented in Item 8. Note 20 .

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. Legal Proceedings 35 Item 4. Mine Safety Disclosures 35 Additional Item. Information About Our Executive Officers 35 Part II. Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 36 Item 6. [Reserved] 36 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 37 Item 7A.
Biggest changeItem 3. Legal Proceedings 34 Item 4. Mine Safety Disclosures 34 Additional Item. Information About Our Executive Officers 35 Part II. Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 36 Item 6. [Reserved] 36 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 37 Item 7A.
Quantitative and Qualitative Disclosures About Market Risk 54 Item 8. Financial Statements and Supplementary Data 56
Quantitative and Qualitative Disclosures About Market Risk 55 Item 8. Financial Statements and Supplementary Data 57

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

10 edited+4 added−3 removed3 unchanged
Biggest changeWillis gained more than 20 years of experience in Human Resources leadership through roles with Fawaz Alhokair Group, GE Capital, DoubleClick, and Norkom Technologies. 56 35 Perrigo Company plc - Item 5 PART II.
Biggest changeWillis gained more than 20 years of experience in Human Resources leadership through roles with Fawaz Alhokair Group, GE Capital, DoubleClick, and Norkom Technologies. 57 Matt Winterman Matt Winterman was named Executive Vice President, Product Supply, Operations Strategy and Transformation Officer, in June 2025. Mr. Winterman has more than 20 years of global supply chain and strategy leadership.
He has also served as global head of corporate legal and was lead counsel for various parts of the self-care business, including supply chain, R&D and innovation, business development, and intellectual property. 48 David Ball Dr. Ball was named Executive Vice President and Chief Brand and Digital Officer in August 2024. Prior to joining Perrigo, Dr.
He has also served as global head of corporate legal and was lead counsel for various parts of the self-care business, including supply chain, R&D and innovation, business development, and intellectual property. 49 David Ball Dr. Ball was named Executive Vice President and Chief Brand and Digital Officer in August 2024. Prior to joining Perrigo, Dr.
He joined Perrigo after more than six years with Kenvue (formerly a part of Johnson & Johnson), where he was Senior Vice President and General Manager of their skin care portfolio, including brand leadership responsibilities. Prior to that role he led Kenvue's consumer brands in Europe. Before his time at Kenvue, Mr.
He joined Perrigo in May 2024 after more than six years with Kenvue (formerly a part of Johnson & Johnson), where he was Senior Vice President and General Manager of their skin care portfolio, including brand leadership responsibilities. Prior to that role he led Kenvue's consumer brands in Europe. Before his time at Kenvue, Mr.
Ball spent more than eight years at Procter and Gamble in leadership positions across multiple business units and functions. 45 Eduardo Bezerra Eduardo Bezerra joined Perrigo in May 2022 as Executive Vice President and Chief Financial Officer. Mr. Bezerra previously served as Senior Vice President and Chief Financial Officer for Del Monte Fresh Produce, Inc., from 2019 to 2022.
Ball spent more than eight years at Procter and Gamble in leadership positions across multiple business units and functions. 46 Eduardo Bezerra Eduardo Bezerra joined Perrigo in May 2022 as Executive Vice President and Chief Financial Officer. Mr. Bezerra previously served as Senior Vice President and Chief Financial Officer for Del Monte Fresh Produce, Inc., from 2019 to 2022.
Khoury spent 13 years at L'Oréal, where he held several leadership roles in the consumer space that included stints in growing pan-European line extensions of leading brands. 44 Abbie Lennox Abbie Lennox was named Executive Vice President and Chief Science Officer in January 2025. Ms.
Khoury spent 13 years at L'Oréal, where he held several leadership roles in the consumer space that included stints in growing pan-European line extensions of leading brands. 45 Abbie Lennox Abbie Lennox was named Executive Vice President and Chief Science Officer in January 2025. Ms.
Lennox joins Perrigo from Bayer where she served as Executive Committee Member and Chief Trust and Science Officer from 2019 to 2024, responsible for leading the regulatory, medical affairs, safety and quality teams.
Lennox joined Perrigo from Bayer where she served as Executive Committee Member and Chief Trust and Science Officer from 2019 to 2024, responsible for leading the regulatory, medical affairs, safety and quality teams.
Atkinson joins Perrigo from Haleon plc and its predecessor, GSK plc, most recently serving as chief legal and compliance officer and Interim General Counsel. During his 20-plus year combined tenure at Haleon/GSK, Mr. Atkinson successfully advised across numerous transactions and integrations, including the creation of Haleon and subsequent separation from its parent shareholders GSK and Pfizer.
Atkinson joined Perrigo from Haleon plc and its predecessor, GSK plc, most recently serving as Interim General Counsel. During his 20-plus year combined tenure at Haleon/GSK, Mr. Atkinson successfully advised across numerous transactions and integrations, including the creation of Haleon and subsequent separation from its parent shareholders GSK and Pfizer.
Prior to this position, he spent more than 20 years with Procter & Gamble in various roles, including brand franchise and general management leadership positions. 56 Catherine T. Schmelter Ms. Schmelter was named Executive Vice President and President Consumer Self-care Americas in September 2023. Prior to joining Perrigo, Ms.
Prior to this position, he spent more than 20 years with Procter & Gamble in various roles, including brand franchise and general management leadership positions. 56 Charles Atkinson Charles Atkinson was named Executive Vice President, General Counsel & Secretary, in October 2024. Mr.
Prior to her time at Bayer, she served in regulatory affairs leadership roles with Reckitt Benckiser, where she advanced the company’s regulatory approach to pipeline delivery across multiple health and wellness brands 44 Patrick Lockwood-Taylor Patrick Lockwood-Taylor was appointed President, Chief Executive Officer and Board Member of Perrigo Company plc, effective June 30, 2023.
Prior to her time at Bayer, she served in regulatory affairs leadership roles with Reckitt Benckiser, where she advanced the company’s regulatory approach to pipeline delivery across multiple health and wellness brands 45 Robert Willis Mr.
Before that, Mr. Bezerra held a number of positions of increasing responsibility at Monsanto Company from 1998 to 2018. 50 Ronald C. Janish Mr. Janish was named Chief Transformation Officer in January 2019 and Executive Vice President of Global Operations and Supply Chain in October 2015.
Before that, Mr. Bezerra held a number of positions of increasing responsibility at Monsanto Company from 1998 to 2018. 51 Roberto Khoury Roberto Khoury was named Executive Vice President and Chief Commercial Officer in July 2025 after serving as Executive Vice President and President, Consumer Self Care International.
Removed
ITEM 4. MINE SAFETY DISCLOSURES Not applicable. ADDITIONAL ITEM. INFORMATION ABOUT OUR EXECUTIVE OFFICERS Our executive officers and their ages and positions as of February 21, 2025 were: Title and Business Experience Age Charles Atkinson Charles Atkinson was named Executive Vice President, General Counsel & Secretary, in October 2024. Mr.
Added
ITEM 4. MINE SAFETY DISCLOSURES Not applicable. 34 Perrigo Company plc - Additional Item Executive Officers ADDITIONAL ITEM.
Removed
He served as Senior Vice President of International and Rx Operations from 2012 until 2015. 59 Roberto Khoury Roberto Khoury was named Executive Vice President and President, Consumer Self Care International in May 2024.
Added
INFORMATION ABOUT OUR EXECUTIVE OFFICERS Our executive officers and their ages and positions as of February 24, 2026 were: Title and Business Experience Age Patrick Lockwood-Taylor Patrick Lockwood-Taylor was appointed President, Chief Executive Officer and Board Member of Perrigo Company plc, effective June 30, 2023.
Removed
Schmelter was most recently at Treehouse Foods from 2016 to 2022, where she held various leadership positions, including Chief Transformation Officer. Prior to Treehouse Foods, Ms. Schmelter spent 10 years at Kraft Foods in various leadership roles, including Vice President of Meals, after beginning her CPG career at General Mills. 55 Robert Willis Mr.
Added
Prior to joining Perrigo, Mr. Winterman served as Senior Vice President of Global Supply Chain and Strategy at AstraZeneca from 2023 to 2025. In this capacity, he was instrumental in driving transformation and strategic investment in the manufacturing network.
Added
He also served as Global Head of end-to-end Supply Chain at Roche Holding AG from 2018 to 2023, and prior to that in roles of increasing responsibility for technical operations strategy and supply chain performance at GSK plc. 55 35 Perrigo Company plc - Item 5 PART II.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

3 edited+0 added−1 removed4 unchanged
Biggest changeAs of December 31, 2024, the approximate value of shares available for purchase under the 2018 Authorization was $835.8 million .
Biggest changeWe did not repurchase any shares during the year ended December 31, 2025 or December 31, 2024 . As of December 31, 2025, the approximate value of shares available for purchase under the 2018 Authorization was $835.8 million .
Information in the graph is presented for the years ended December 31, 2019 through December 31, 2024. * $100 invested on December 31, 2019 - in stock or index - including reinvestment of dividends. Indexes calculated on month-end basis.
Information in the graph is presented for the years ended December 31, 2020 through December 31, 2025. * $100 invested on December 31, 2020 - in stock or index - including reinvestment of dividends. Indexes calculated on month-end basis.
As of February 21, 2025, there were 4,088 record holders of our ordinary shares. In January 2003, the Board of Directors adopted a policy of paying quarterly dividends. During the year ended December 31, 2024, we declared and paid $152.5 million in dividends.
As of February 24, 2026, there were 4,053 record holders of our ordinary shares. In January 2003, the Board of Directors adopted a policy of paying quarterly dividends. During the year ended December 31, 2025, we declared and paid $159.3 million in dividends.
Removed
We did not repurchase any shares during the year ended December 31, 2024 or December 31, 2023 . During the year ended December 31, 2021 , we repurchased 3.4 million ordinary shares at an average purchase price of $48.28 per share for a total of $164.2 million under the 2018 Authorization .

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

96 edited+67 added−58 removed58 unchanged
Biggest changeCSCI net sales by product category were as follows: Sales Year Ended (in millions, except percentages) December 31, 2024 December 31, 2023 (1) $ Change % Change Skin Care $ 410.0 $ 372.5 $ 37.5 10.1 % Upper Respiratory 282.1 299.1 (17.0) (5.7) % Healthy Lifestyle 225.8 225.7 0.1 — % Pain and Sleep-Aids 222.2 222.9 (0.7) (0.4) % VMS 173.5 185.5 (12.0) (6.6) % Women's Health 132.8 119.7 13.1 11.0 % Oral Care 99.4 101.5 (2.1) (2.0) % Digestive Health 36.5 41.0 (4.5) (11.0) % Other CSCI 97.3 125.4 (28.1) (22.4) % Total CSCI $ 1,679.6 $ 1,693.3 $ (13.7) (0.8)% (1) We updated our global reporting product categories as a result of our product portfolio reconfiguration.
Biggest changeCSCI net sales by product category were as follows: Sales Year Ended (in millions, except percentages) December 31, 2025 December 31, 2024 $ Change % Change Skin Care $ 407.7 $ 410.0 $ (2.4) (0.6) % Upper Respiratory 288.2 282.1 6.0 2.1 % Pain and Sleep-Aids 235.4 222.2 13.3 6.0 % Healthy Lifestyle 231.5 225.8 5.7 2.5 % VMS 161.2 173.5 (12.3) (7.1) % Women's Health 143.5 132.8 10.7 8.0 % Oral Care 97.5 99.4 (2.0) (2.0) % Digestive Health 40.3 36.5 3.8 10.4 % Other CSCI 62.4 97.3 (34.8) (35.8) % Total CSCI $ 1,667.7 $ 1,679.6 $ (11.9) (0.7)% 44 Perrigo Company plc - Item 7 CSCI Sales in each category were driven primarily by: • Skin Care: Net sales of $407.7 million decreased 0.6%, inclusive of a 2.4% favorable effect of currency translation, due primarily to lower net sales in the ACO ® franchise, partially offset by higher net sales and new products in the Compeed ® franchise; • Upper Respiratory: Net sales of $288.2 million increased 2.1%, inclusive of a 4.0% favorable effect of currency translation, due primarily to lower net sales of cough cold products stemming from lower incidence of cough cold throughout the E.U. compared to the prior year, as well as an unfavorable impact of 1.5% from divested businesses and exited product lines.
Cash, cash equivalents, restricted cash, cash flows from operations, and borrowings available under our credit facilities are expected to be sufficient to finance our liquidity and capital expenditures in both the short and long term.
Cash, cash equivalents, cash flows from operations, and borrowings available under our credit facilities are expected to be sufficient to finance our liquidity and capital expenditures in both the short and long term.
Management's Discussion and Analysis of Financial Condition and Results of Operations in Part II of our Annual Report on Form 10-K for the year ended December 31, 2023. EXECUTIVE OVERVIEW Perrigo is a leading pure-play self-care company with more than a century of providing high-quality health and wellness solutions to meet the evolving needs of consumers.
Management's Discussion and Analysis of Financial Condition and Results of Operations in Part II of our Annual Report on Form 10-K for the year ended December 31, 2024. EXECUTIVE OVERVIEW Perrigo is a leading pure-play self-care company with more than a century of providing high-quality health and wellness solutions to meet the evolving needs of consumers.
Additionally, the final determination with respect to any tax audit, and any related litigation, could be materially different from our estimates or from our historical income tax provisions and accruals. Future period earnings may also be adversely impacted by litigation costs, settlements, penalties, and/or interest assessments. Refer to Item 8. Note 18 for additional details on the Company's income taxes.
Additionally, the final determination with respect to any tax audit, and any related litigation, could be materially different from our estimates or from our historical income tax provisions and accruals. Future period earnings may also be adversely impacted by litigation costs, settlements, penalties, and/or interest assessments. Refer to Item 8. Note 19 for additional details on the Company's income taxes.
Additionally, we increased our dividend payment by $2.8 million compared to the prior year. Share Repurchases In October 2018, our Board of Directors authorized up to $1.0 billion of share repurchases with no expiration date, subject to the Board of Directors’ approval of the pricing parameters and amount that may be repurchased under each specific share repurchase program.
Additionally, we increased our dividend payment by $6.8 million compared to the prior year. Share Repurchases In October 2018, our Board of Directors authorized up to $1.0 billion of share repurchases with no expiration date, subject to the Board of Directors’ approval of the pricing parameters and amount that may be repurchased under each specific share repurchase program.
Israel is a global technology research and development center that plays a critical role to the global Active Pharmaceutical Ingredients ("API") market, as a number of key suppliers are located within Israel. The Company sources some raw materials and finished goods from suppliers in Israel for certain self-care products, including Omeprazole.
Israel is a global technology research and development center that plays a critical role in the global Active Pharmaceutical Ingredients ("API") market, as a number of our key suppliers are located within Israel. The Company sources some raw materials and finished goods from suppliers in Israel for certain self-care products, including omeprazole.
This MD&A is provided as a supplement to, and should be read in conjunction with, our Consolidated Financial Statements and accompanying Notes found in Item 8 of this report. See also " Cautionary Note Regarding Forward-Looking Statements ." This discussion and analysis compares 2024 results to 2023. For discussion and analysis that compares 2023 results to 2022, see Item 7.
This MD&A is provided as a supplement to, and should be read in conjunction with, our Consolidated Financial Statements and accompanying Notes found in Item 8 of this report. See also " Cautionary Note Regarding Forward-Looking Statements ." This discussion and analysis compares 2025 results to 2024. For discussion and analysis that compares 2024 results to 2023, see Item 7.
Note 19 for additional details on the Company's contingencies. Acquisition Accounting We account for acquired businesses using the acquisition method of accounting, which requires that assets acquired and liabilities assumed be recorded at fair value, with limited exceptions. Any excess of the purchase price over the fair value of the specifically identified assets is recorded as goodwill.
Note 20 for additional details on the Company's contingencies. Acquisition Accounting We account for acquired businesses using the acquisition method of accounting, which requires that assets acquired and liabilities assumed be recorded at fair value, with limited exceptions. Any excess of the purchase price over the fair value of the specifically identified assets is recorded as goodwill.
Borrowings and Capital Resources Note Issuances On September 17, 2024, Perrigo Finance issued the 2032 Notes as defined in Item 8. Note 12 . The 2032 Notes are fully and unconditionally guaranteed on a senior unsecured basis by Perrigo and its subsidiaries that provide guarantees under Perrigo's Senior Secured Credit Facilities (as defined below).
Borrowings and Capital Resources Note Issuances On September 17, 2024, Perrigo Finance issued the 2032 Notes as defined in Item 8. Note 13 . The 2032 Notes are fully and unconditionally guaranteed on a senior unsecured basis by Perrigo and its subsidiaries that provide guarantees under Perrigo's Senior Secured Credit Facilities (as defined below).
Contractual Obligations Our enforceable and legally binding obligations as of December 31, 2024 are set forth in the following table. Some of the amounts included in this table are based on management’s estimates and assumptions about these obligations, including the duration, the possibility of renewal, anticipated actions by third parties and other factors.
Contractual Obligations Our enforceable and legally binding obligations as of December 31, 2025 are set forth in the following table. Some of the amounts included in this table are based on management’s estimates and assumptions about these obligations, including the duration, the possibility of renewal, anticipated actions by third parties and other factors.
Applicable margins and fees are outlined below: Applicable Margins Term SOFR and EURIBOR Rates Prime Lending and Daily Simple RFR Rates Per Annum Commitment Fee (2) Term A Loans (1) 2.000% - 1.750% 1.000% - 0.750% — Term B Loans (1) 2.500% - 2.000% 1.500% - 1.250% — Revolver (1) 2.000% - 1.375% 1.000% - 0.375% 0.250% - 0.175% (1) Applicable margins are dependent upon our total net leverage ratio (2) Payable on the undrawn amount The Credit Agreement is guaranteed by us and certain of our wholly-owned subsidiaries organized in the U.S., Ireland, Belgium, England and Wales (subject to certain exceptions) (the “Guarantor Subsidiaries” and together with the Company, the “Guarantors” and together with the Borrower, the "Loan Parties").
Applicable margins and fees are outlined below: Applicable Margins Term SOFR Rate, EURIBOR Rate and Daily Simple RFR Prime Rate and Daily Simple RFR Per Annum Commitment Fee (2) Term A Loans (1) 2.000% - 1.750% 1.000% - 0.750% — Term B Loans 2.000% 1.000% — Revolver (1) 2.000% - 1.375% 1.000% - 0.375% 0.250% - 0.175% (1) Applicable margins are dependent upon our total net leverage ratio (2) Payable on the undrawn amount The Credit Agreement is guaranteed by us and certain of our wholly-owned subsidiaries organized in the U.S., Ireland, Belgium, England and Wales (subject to certain exceptions) (the “Guarantor Subsidiaries” and together with the Company, the “Guarantors” and together with the Borrower, the "Loan Parties").
RESULTS OF OPERATIONS Currency Translation Any currency translation effects described below represent estimates of the net differences between translation of foreign currency transactions into U.S. dollars for the year ended December 31, 2024 at the average exchange rates for the reporting period and average exchange rates for the year ended December 31, 2023.
RESULTS OF OPERATIONS Currency Translation Any currency translation effects described below represent estimates of the net differences between translation of foreign currency transactions into U.S. dollars for the year ended December 31, 2025 at the average exchange rates for the reporting period and average exchange rates for the year ended December 31, 2024.
We did not repurchase any shares during the year ended December 31, 2024 or December 31, 2023. The future repurchase of shares, if any, is subject to the discretion of our Board of Directors. Dividends In January 2003, the Board of Directors adopted a policy of paying quarterly dividends.
We did not repurchase any shares during the year ended December 31, 2025 or December 31, 2024. The future repurchase of shares, if any, is subject to the discretion of our Board of Directors. Dividends In January 2003, the Board of Directors adopted a policy of paying quarterly dividends.
The interest rate net of derivatives results in a fixed rate on a substantial portion of our long-term debt, the earliest of which matures in April 2027. We are in compliance with all the covenants under our debt agreements as of December 31, 2024.
The interest rate net of derivatives results in a fixed rate on a substantial portion of our long-term debt, the earliest of which matures in April 2027. We are in compliance with all the covenants under our debt agreements as of December 31, 2025.
As a result of the redemption, we recognized an extinguishment loss of $6.7 million during the year.
As a result of the redemption, we recognized an extinguishment loss of $6.7 million during the prior year.
Loans under the Credit Agreement bear interest at a rate equal to, at the Borrower’s option and depending on the currency borrowed, either the adjusted Term SOFR Rate, EURIBOR Rate, the prime lending rate or the daily simple RFR rate (each as defined in the Credit Agreement), in each case, plus an applicable margin.
Loans under the Credit Agreement bear interest at a rate equal to, at the Borrower’s option and depending on the currency borrowed, either the adjusted Term SOFR Rate, adjusted EURIBOR Rate, adjusted Daily Simple RFR or ABR (each as defined in the Credit Agreement), in each case, plus an applicable margin.
We have incurred certain extraordinary non-recurring costs associated with the remediation and enhancement actions described above and the evolving U.S. infant formula regulatory landscape, including consulting and legal fees relating to the Company’s responses to the FDA and the development and implementation of new protocols across our infant formula manufacturing sites, as well as other costs relating to the extended cleaning and sanitization and the pausing and restarting of production.
We incurred certain extraordinary non-recurring costs associated with the remediation and enhancement actions described above and the evolving U.S. infant formula regulatory landscape, including consulting and legal fees relating to our responses to the FDA and the development and institution of new protocols across our infant formula manufacturing sites, as well as other costs relating to the extended cleaning and sanitization and the pausing and restarting of production.
We are committed to making the required minimum contributions, which we expect to be approximately $39.1 million over the next 12 months. Future contributions are dependent upon various factors, including employees’ eligible compensation, plan participation and changes, if any, to current funding requirements. Therefore, no amounts were included in the Contractual Obligations table above.
We are committed to making the required minimum contributions, which we expect to be approximately $37.9 million over the next 12 months. Future contributions are dependent upon various factors, including employees’ eligible compensation, plan participation and changes, if any, to current funding requirements. Therefore, no amounts were included in the Contractual Obligations table above.
Infant Formula As part of its efforts to prevent supply interruptions and risk of Cronobacter spp. illnesses associated with powdered infant formula, in March 2023, the FDA released an “Immediate National Strategy to Increase the Resiliency of the U.S.
Infant Formula As part of its efforts to prevent supply interruptions and risk of Cronobacter spp. illnesses associated with powdered infant formula, in March 2023, the Federal Drug Administration ("FDA") released an “Immediate National Strategy to Increase the Resiliency of the U.S.
Middle East Conflicts We continue to closely monitor the ongoing conflict and the social, political and economic environment in Israel and in the surrounding region to evaluate the impacts on our operations and supply chain.
Middle East Conflicts We continue to closely monitor the ongoing conflict and the social, political and economic environment in Israel and in the broader Middle East to evaluate the impacts on our operations and supply chain.
We generally expect to fund all future contributions with cash flows from operating activities. As of December 31, 2024, we had approximately $309.8 million of liabilities for uncertain tax positions, including interest and penalties.
We generally expect to fund all future contributions with cash flows from operating activities. As of December 31, 2025, we had approximately $391.8 million of liabilities for uncertain tax positions, including interest and penalties.
The ultimate outcome of any litigation or other contingency may be material to our results of operations, financial condition and cash flows. At December 31, 2024 and 2023, the loss accrual for litigation contingencies reflected on the balance sheet in Other accrued liabilities was $76.8 million and $66.9 million, respectively. Refer to Item 8.
The ultimate outcome of any litigation or other contingency may be material to our results of operations, financial condition and cash flows. At December 31, 2025 and 2024, the loss accrual for litigation contingencies reflected on the balance sheet in Other accrued liabilities was $59.0 million and $76.8 million, respectively. Refer to Item 8.
(Gain) loss on extinguishment of debt The $6.7 million loss on extinguishment of debt during the year ended December 31, 2024 is primarily related to the unamortized fees associated with the partial payment on the Term Loan B Facility (refer to Item 8. Note 12 ).
Loss on extinguishment of debt The $6.7 million loss on extinguishment of debt during the year ended December 31, 2024 was primarily related to the unamortized fees associated with the partial payment on the Term Loan B Facility (refer to Item 8. Note 13 ).
We paid dividends as follows: Year Ended December 31, 2024 December 31, 2023 Dividends paid (in millions) $ 152.5 $ 149.7 Dividends paid per share $ 1.10 $ 1.09 The declaration and payment of dividends, if any, is subject to the discretion of our Board of Directors and will depend on our earnings, financial condition, availability of distributable reserves, capital and surplus requirements, and other factors our Board of Directors may consider relevant.
We paid dividends as follows: Year Ended December 31, 2025 December 31, 2024 Dividends paid (in millions) $ 159.3 $ 152.5 Dividends paid per share $ 1.16 $ 1.10 The declaration and payment of dividends, if any, is subject to the discretion of our Board of Directors and will depend on our earnings, financial condition, availability of distributable reserves, capital and surplus requirements, and other factors our Board of Directors may consider relevant.
Credit Agreements On April 20, 2022, we and our indirect wholly-owned subsidiary, Perrigo Investments, LLC (the "Borrower") entered into the senior secured credit facilities, which consisted of (i) a $1.0 billion five-year revolving credit facility (the "Revolver"), (ii) a $500.0 million five-year Term Loan A facility (the "Term Loan A Facility" and the Term A Loans thereunder, the "Term A Loans"), and (iii) a $1.1 billion seven-year Term Loan B Facility (the "Term Loan B Facility" and the Term B Loans thereunder borrowed on April 20, 2022, the "2022 Term B Loans" and, together with the Revolver and Term Loan A Facility, the "Senior Secured Credit Facilities"), pursuant to a Term Loan and Revolving Credit Agreement (the "Credit Agreement").
Credit Agreements On April 20, 2022, we and our indirect wholly-owned subsidiary, Perrigo Investments, LLC (the "Borrower") entered into the senior secured credit facilities, which consisted of (i) a $1.0 billion five-year revolving credit facility (the "Revolver"), (ii) a $500.0 million five-year Term Loan A facility (the "Term Loan A Facility" and the Term A Loans thereunder, the "Term A Loans"), and (iii) a $1.1 billion seven-year Term Loan B facility (the "Term Loan B Facility" and the Term B Loans thereunder borrowed on April 20, 2022, the "2022 Term B Loans" and, together with the 48 Perrigo Company plc - Item 7 Financial Condition, Liquidity and Capital Resources Revolver and Term Loan A Facility, the "Senior Secured Credit Facilities"), pursuant to a Credit Agreement (the "Credit Agreement").
Our assessment as to the useful lives of intangible assets is based on a number of factors including competitive environment, market share, trademark, brand history, underlying product life cycles, operating plans and the macroeconomic environment of the countries in which the trademarked or branded products are sold.
Our assessment as to the useful lives of intangible assets is based on a number of factors including competitive environment, market share, trademark, brand history, underlying product life cycles, operating plans and the 53 Perrigo Company plc - Item 7 Critical Accounting Estimates macroeconomic environment of the countries in which the trademarked or branded products are sold.
Term Loans and Notes As of December 31, 2024 and December 31, 2023, we had $1,429.1 million and $1,858.1 million , respectively, outstanding under our Term Loan A Facility and Term Loan B Facility .
Term Loans and Notes As of December 31, 2025 and December 31, 2024, we had $1,394.3 million and $1,429.1 million , respectively, outstanding under our Term Loan A Facility and Term Loan B Facility .
In our annual impairment test as of September 29, 2024, discount rates ranged from 10.00% to 11.25%, and perpetual growth rates were 2.50%. In our annual impairment test as of October 1, 2023, discount rates ranged from 10.75% to 12.00%, and perpetual growth rates were 2.50%.
In our annual impairment test as of September 29, 2024, discount rates ranged from 10.50% to 11.25%, and perpetual growth rates were 2.50%.
Our Segments 37 Perrigo Company plc - Item 7 Executive Overview Our reporting and operating segments reflect the way our chief operating decision maker, who is our CEO, makes operating decisions, allocates resources and manages the growth and profitability of the Company.
Our Segments Our reporting and operating segments reflect the way our chief operating decision maker, who is our Chief Executive Officer ("CEO"), makes operating decisions, allocates resources and manages the growth and profitability of the Company.
The tender offer was settled on 48 Perrigo Company plc - Item 7 Financial Condition, Liquidity and Capital Resources December 15, 2023, and Perrigo Finance accepted for purchase $300.0 million of the 2024 Notes and paid approximately $295.1 million in aggregate cash consideration (excluding accrued interest).
The tender offer was settled on December 15, 2023, and Perrigo Finance accepted for purchase $300.0 million of the 2024 Notes and paid approximately $295.1 million in aggregate cash consideration (excluding accrued interest).
As part of the Company's sustainable, value accretive growth strategy, the Company launched Project Energize - a global investment and efficiency program to drive the next evolution of capabilities and organizational agility.
Project Energize As part of our sustainable, value accretive growth strategy, we launched Project Energize in the first quarter of 2024 - a global investment and efficiency program to drive the next evolution of capabilities and organizational agility.
The Credit Agreement contains customary representations and warranties and customary affirmative and negative covenants applicable to the Borrower and its restricted subsidiaries, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of junior indebtedness and dividends and other distributions.
The Credit Agreement contains customary representations and warranties and customary affirmative and negative covenants applicable to the Borrower and 49 Perrigo Company plc - Item 7 Financial Condition, Liquidity and Capital Resources its restricted subsidiaries, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of junior indebtedness and dividends and other distributions.
If the reasonable estimate of a probable loss is a range and no amount within that range is a better estimate, the minimum amount in the range is accrued. If a loss is not probable or a probable loss cannot be 52 Perrigo Company plc - Item 7 Critical Accounting Estimates reasonably estimated, no liability is recorded.
If the reasonable estimate of a probable loss is a range and no amount within that range is a better estimate, the minimum amount in the range is accrued. If a loss is not probable or a probable loss cannot be reasonably estimated, no liability is recorded.
GAAP, are excluded from the below summarized financial information pursuant to SEC Regulation S-X Rule 13-01. 50 Perrigo Company plc - Item 7 Financial Condition, Liquidity and Capital Resources The summarized balance sheet information for the consolidated obligor group of debt issued by Perrigo Finance and the Company is presented in the table below: Year Ended (in millions) December 31, 2024 December 31, 2023 Current assets $ 1,792.5 $ 1,999.9 Non-current assets $ 4,284.5 $ 4,596.2 Current liabilities $ 731.8 $ 1,888.8 Non-current liabilities $ 12,144.5 $ 11,498.4 Due to non-guarantors $ 8,131.3 $ 7,355.3 The summarized results of operations information for the consolidated obligor group of debt issued by Perrigo Finance and the Company is presented in the table below: Year Ended (in millions) December 31, 2024 December 31, 2023 Total revenues $ 3,118.4 $ 3,308.8 Gross profit $ 944.6 $ 979.2 Operating income (loss) $ (27.8) $ 62.1 Net income (loss) $ (147.5) $ (10.9) Revenue from non-guarantors $ 529.3 $ 186.1 Operating expenses to non-guarantors $ (1.8) $ (1.1) Other (income) expense to non-guarantors $ (182.9) $ (97.7) Off-Balance Sheet Arrangements We have no off-balance sheet arrangements that have a material current effect or that are reasonably likely to have a material future effect on our financial condition, changes in financial condition, net sales or expenses, results of operations, liquidity, capital expenditures, or capital resources.
The summarized balance sheet information for the consolidated obligor group of debt issued by Perrigo Finance and the Company is presented in the table below: Year Ended (in millions) December 31, 2025 December 31, 2024 Current assets $ 1,919.1 $ 1,792.5 Non-current assets $ 3,959.8 $ 4,284.5 Current liabilities $ 720.6 $ 731.8 Non-current liabilities $ 10,216.1 $ 12,144.5 Due to non-guarantors $ 6,020.6 $ 8,131.3 The summarized results of operations information for the consolidated obligor group of debt issued by Perrigo Finance and the Company is presented in the table below: Year Ended (in millions) December 31, 2025 December 31, 2024 Total revenues $ 3,064.7 $ 3,118.4 Gross profit $ 911.8 $ 944.6 Operating income (loss) $ (17.6) $ (27.8) Net income (loss) $ 791.2 $ (147.5) Revenue from non-guarantors $ 374.3 $ 529.3 Operating expenses to non-guarantors $ (1.3) $ (1.8) Other (income) expense to non-guarantors $ (1,072.1) $ (182.9) Off-Balance Sheet Arrangements We have no off-balance sheet arrangements that have a material current effect or that are reasonably likely to have a material future effect on our financial condition, changes in financial condition, net sales or expenses, results of operations, liquidity, capital expenditures, or capital resources.
Refer to Item 8. Note 3 and Note 9 for additional details of the divestiture and impairments recognized as a result of the sale.
Note 3 and Note 10 for additional details of the divestiture and impairments recognized as a result of the sale.
In North America, Perrigo is the leading store brand private label provider of self-care products in many categories, including upper respiratory, nutrition and women's health, along with brands including Opill ® and Mederma ® . In Europe, our portfolio consists primarily of brands, including Compeed ® , EllaOne ® , Solpadeine ® , and ACO ® .
In North America, Perrigo is the leading store brand private label provider of self-care products in many categories, including upper respiratory, healthy lifestyle and women's health, along with brands including Opill ® and Mederma ® .
We continue to monitor the progress of our reporting units and assess them for potential impairment should impairment indicators arise, as applicable, and at least annually during our fourth quarter impairment testing. See Item 8. Note 9 and Note 10 for further information. Recently Issued Accounting Standards Pronouncements See Item 8. Note 1 for information regarding recently issued accounting standards.
We continue to monitor the progress of our reporting units and assess them for potential impairment should impairment indicators arise, as applicable, and at least annually during our fourth quarter impairment testing. See Item 8. Note 10 and Note 11 for further information. In connection with the January 1, 2026 segment reorganization (see Item 8.
There were no borrowings outstanding under the overdraft facilities as of December 31, 2024 and December 31, 2023. There w ere no b orrowings outstanding under the Revolver as of December 31, 2024 or December 31, 2023. We are subject to certain financial covenants in the Revolver and Credit Agreement.
There w ere no b orrowings outstanding under the Revolver as of December 31, 2025 or December 31, 2024. We are subject to certain financial covenants in the Revolver and Credit Agreement. As of December 31, 2025, we were in compliance with all such covenants under our debt agreements.
The Term B Loans will mature on April 20, 2029. The net proceeds from the Incremental Term B Loans were used to settle the cash tender offer by Perrigo Finance for $300.0 million in aggregate principal amount of 3.900% Senior Notes due 2024 ("2024 Notes").
The terms of the 2023 Incremental Term B Loans, including pricing and maturity, are identical to the 2022 Term B Loans. The net proceeds from the 2023 Incremental Term B Loans were used to settle the cash tender offer by Perrigo Finance for $300.0 million in aggregate principal amount of 3.900% Senior Notes due 2024 ("2024 Notes").
As part of this effort, the Company conducted an extended site-wide assessment and cleaning. The Company also bolstered its internal resources and brought in additional outside expertise to help revise, enhance and strengthen comprehensive standards and processes across our infant formula network, including in some instances, pausing production for comprehensive cleaning and infrastructure improvements.
We also bolstered our internal resources and brought in additional outside expertise to help revise, enhance and strengthen comprehensive standards and processes across our infant formula network, including in some instances, pausing production for comprehensive cleaning and infrastructure improvements.
While the Company was working to resolve the issues raised in the August 30 letter, on November 29, 2023, the Company received notice from the FDA of additional inspection observations relating to Perrigo Wisconsin. Consistent with the Company’s commitment to quality, the Company temporarily paused all production at that facility to address the FDA's observations.
While we worked to resolve the issues raised in the August 30 letter, on November 29, 2023, we received notice from the FDA of additional inspection observations relating to Perrigo Wisconsin. Consistent with our commitment to quality, we temporarily paused all production at that facility and conducted an extended site-wide assessment and cleaning.
Income Taxes (Consolidated) The effective tax rates were as follows: Year Ended December 31, 2024 December 31, 2023 (99.3) % 47.2 % The effective tax rate on the pre-tax loss for the year ended December 31, 2024, increased when compared to the effective tax rate on the pre-tax loss for the year ended December 31, 2023, primarily due to the net impact of an intercompany intellectual property sale, and the establishment of a partial valuation allowance in the United States, offset by the impact of audit settlements in the prior year.
Income Taxes (Consolidated) The effective tax rates were as follows: Year Ended December 31, 2025 December 31, 2024 (8.0) % (99.3) % The effective tax rate on the pre-tax loss for the year ended December 31, 2025 decreased when compared to the effective tax rate on the pre-tax loss for the year ended December 31, 2024, primarily due to the impact of the One Big Beautiful Bill Act ("OBBBA") in 2025 and the net impact of an intercompany intellectual property sale in 2024, offset by the establishment of a full valuation allowance in the United States and the impact of the goodwill impairment charges in 2025.
These decreases were partially offset by increased restructuring expense of approximately $32 million. Unallocated Expenses Unallocated expenses are comprised of certain corporate services not allocated to our reporting segments and are recorded in Operating income on the Consolidated Statements of Operations.
Unallocated Expenses Unallocated expenses are comprised of certain corporate services not allocated to our reporting segments and are recorded in Operating income on the Consolidated Statements of Operations.
During the three months ended September 28, 2024, we recorded impairment charge of $5.4 million for our CSCI reporting unit related to the now divested Hospital & Specialty disposal group. During 2023, we recorded goodwill impairment charges of $90.0 million.
During the three months ended September 28, 2024, we recorded an impairment charge of $5.4 million for our CSCI reporting unit related to the now divested Hospital & Specialty 54 Perrigo Company plc - Item 7 Critical Accounting Estimates disposal group.
Interest expense, net, Other (income) expense, net and (Gain) Loss on extinguishment of debt (Consolidated) Year Ended (in millions) December 31, 2024 December 31, 2023 Interest expense, net $ 187.8 $ 173.8 Other (income) expense, net $ (0.9) $ (10.4) (Gain) loss on extinguishment of debt $ 6.7 $ (3.2) 45 Perrigo Company plc - Item 7 Unallocated, Interest, Other, and Taxes Interest Expense, net The $14.0 million increase during the year ended December 31, 2024 compared to the prior year was due primarily to the de-designation of interest rate swap agreements.
Interest expense, net, Other (income) expense, net and Loss on extinguishment of debt (Consolidated) Year Ended (in millions) December 31, 2025 December 31, 2024 Interest expense, net $ 162.5 $ 187.8 Other (income) expense, net $ 13.2 $ (0.9) Loss on extinguishment of debt $ — $ 6.7 45 Perrigo Company plc - Item 7 Unallocated, Interest, Other, and Taxes Interest Expense, net The $25.3 million decrease during the year ended December 31, 2025 compared to the prior year was due primarily to the absence of interest expense associated with the de-designation of interest rate swap agreements in the prior year and a decrease in interest expense associated with a decrease in outstanding borrowings under our Senior Secured Credit Facilities.
Any causes of market size contraction could reduce our sales or erode our operating margin and consequently reduce our net earnings and cash flows. Our interest expense is impacted by the overall global economic and interest rate environment.
Any causes of market size contraction could reduce our sales or erode our operating margin and consequently reduce our net earnings and cash flows.
Certain macroeconomic factors which are not controlled by the reporting units, such as rising inflation or interest rates, could cause an increase in the discount rate to occur.
An increase in the discount rate over the next twelve months could negatively impact the estimated fair value of the reporting units and lead to a future impairment. Certain macroeconomic factors which are not controlled by the reporting units, such as rising inflation or interest rates, could cause an increase in the discount rate to occur.
Unallocated expenses were as follows (in millions): Year Ended December 31, 2024 December 31, 2023 $ 262.1 $ 202.5 The increase of $59.6 million in unallocated expenses during the year ended December 31, 2024 compared to the prior year period was due primarily to an increase in expenses for litigation as well as restructuring costs associated primarily with Project Energize.
Unallocated expenses were as follows (in millions): Year Ended December 31, 2025 December 31, 2024 $ 224.3 $ 262.1 The decrease of $37.8 million in unallocated expenses during the year ended December 31, 2025 compared to the prior year period was due primarily to lower variable employee expenses, as well as lower restructuring costs associated primarily with Project Energize.
Note 12 , the Guarantor Subsidiaries and the Borrower provide full and unconditional guarantees, jointly and severally, on a senior unsecured basis, of the 5.300% Notes due 2043 issued by the Company, and the Loan Parties provide full and unconditional guarantees, jointly and severally, on a senior unsecured basis, of the 4.900% Notes due 2030, the 5.375% Euro Notes due 2032, the 6.125% USD Notes due 2032, and the 4.900% Notes due 2044 issued by Perrigo Finance.
Note 13 , the Guarantor Subsidiaries and the Borrower provide full and unconditional guarantees, jointly and severally, on a senior unsecured basis, of the 5.300% Notes due 2043 issued by the Company, and the Loan Parties provide full and unconditional guarantees, jointly and severally, on a senior unsecured basis, of the 4.900% Notes due 2030, the 5.375% Euro Notes due 2032, the 6.125% USD Notes due 2032, and the 4.900% Notes due 2044 issued by Perrigo Finance. 50 Perrigo Company plc - Item 7 Financial Condition, Liquidity and Capital Resources The guarantees of the Guarantor Subsidiaries, the Company and the Borrower are subject to release in limited circumstances only upon the occurrence of certain customary conditions.
(5) Primarily includes consulting fees, legal settlements, restructuring accruals, insurance obligations, and electrical and gas purchase contracts, which were accrued in Other current liabilities and Other non-current liabilities at December 31, 2024 for all years.
These amounts are assumed payable after five years, although certain circumstances, such as termination, would require earlier payment. (5) Primarily includes consulting fees, legal settlements, restructuring accruals, insurance obligations, and electrical and gas purchase contracts, which were accrued in Other current liabilities and Other non-current liabilities at December 31, 2025 for all years.
Because these estimates and assumptions are necessarily subjective, the enforceable and legally binding obligations actually paid in future periods may vary from the amounts reflected in the table (in millions): Payment Due 2025 2026-2027 2028-2029 After 2029 Total Short and long-term debt (1) $ 273.0 $ 891.8 $ 1,296.7 $ 2,703.8 $ 5,165.3 Finance lease obligations 2.0 3.2 3.2 7.4 15.8 Purchase obligations (2) 316.8 — — — 316.8 Operating leases (3) 33.4 54.5 36.6 89.3 213.8 Other contractual liabilities reflected on the consolidated balance sheets: Deferred compensation and benefits (4) — — — 41.7 41.7 Other (5) 115.2 98.2 1.8 — 215.2 Total $ 740.4 $ 1,047.7 $ 1,338.3 $ 2,842.2 $ 5,968.6 (1) Short-term and long-term debt includes interest payments, which were calculated using the effective interest rate at December 31, 2024.
Because these estimates and assumptions are necessarily subjective, the enforceable and legally binding obligations actually paid in future periods may vary from the amounts reflected in the table (in millions): 51 Perrigo Company plc - Item 7 Financial Condition, Liquidity and Capital Resources Payment Due 2026 2027-2028 2029-2030 After 2030 Total Short and long-term debt (1) $ 275.6 $ 837.2 $ 1,940.1 $ 1,905.8 $ 4,958.7 Finance lease obligations 2.1 3.6 3.3 5.7 14.7 Purchase obligations (2) 275.2 — — — 275.2 Operating leases (3) 31.5 55.1 36.3 85.3 208.2 Other contractual liabilities reflected on the consolidated balance sheets: Deferred compensation and benefits (4) — — — 58.9 58.9 Other (5) 125.9 47.1 — — 173.0 Total $ 710.3 $ 943.0 $ 1,979.7 $ 2,055.7 $ 5,688.7 (1) Short-term and long-term debt includes interest payments, which were calculated using the effective interest rate at December 31, 2025.
Our short term debt as of December 31, 2024 of $36.4 million is comprised of (i) amortization payments for the Term A Loans and the Term B Loans and (ii) lease payments.
The Term B Loans will mature on April 20, 2029. Refer to Item 8. Note 13 . Our short term debt as of December 31, 2025 of $36.6 million is comprised of (i) amortization payments for the Term A Loans and the Term B Loans and (ii) lease payments.
These investments included, among other things, enhancing our cleaning and sanitation protocols, our environmental monitoring programs, and quality oversight, as well as increasing the number of quality and operations personnel at the sites. These changes resulted in higher costs, lower manufacturing output, and lower production yields across our infant formula network.
These investments included, among other things, enhancing our cleaning and sanitation protocols, our environmental monitoring programs, and quality oversight, as well as increasing the number of quality and operations personnel at the sites, including enhanced cleaning and sanitation protocols, enhancements to our environmental monitoring programs, enhanced quality oversight and additional quality and operations personnel.
This three-year program is expected to produce significant benefits in the Company’s long-term business performance by enabling our One Perrigo growth strategy, increasing organizational agility and mitigating impacts from stabilizing and strengthening the infant formula business.
This three-year program was expected to produce significant benefits in our long-term business performance by enabling 40 Perrigo Company plc - Item 7 Executive Overview our One Perrigo growth strategy, increasing organizational agility and mitigating impacts from stabilizing and strengthening the infant formula business. As of December 31, 2025, Project Energize had achieved these objectives and has substantively completed.
In determining our future capital requirements, we regularly consider, among other factors, known trends and uncertainties, such as the war in Ukraine and conflicts in the Middle East, inflation and interest rates, the status of material contingent liabilities, recent financial market volatility and other uncertainties.
In determining our future capital requirements, we regularly consider, among other factors, 46 Perrigo Company plc - Item 7 Financial Condition, Liquidity and Capital Resources known trends and uncertainties, such as the geopolitical environment, inflation and interest rates, the status of material contingent liabilities, financial market volatility, tariffs and potential tariff and trade policies and other uncertainties.
(2) Consists of commitments for both materials and services. (3) Used in normal course of business, principally for warehouse facilities and computer equipment. 51 Perrigo Company plc - Item 7 Financial Condition, Liquidity and Capital Resources (4) Includes amounts associated with non-qualified plans related to deferred compensation, executive retention and post-employment benefits.
(2) Consists of commitments for both materials and services. (3) Used in normal course of business, principally for warehouse facilities and computer equipment. (4) Includes amounts associated with non-qualified plans related to deferred compensation, executive retention and post-employment benefits. Of this amount, we have funded $35.3 million, which is recorded in Other non-current assets on the balance sheet.
War in Ukraine The invasion of Ukraine by Russia and resulting economic and political sanctions imposed by the United States, United Kingdom, European Union, and other countries on Russia, Belarus, and occupied regions in Ukraine have negatively impacted our results from operations in the region.
We manage interest rate risk through our capital structure and the use of interest rate swaps to fix the interest rate on greater than 90% of our outstanding debt. 38 Perrigo Company plc - Item 7 Executive Overview War in Ukraine The invasion of Ukraine by Russia and resulting economic and political sanctions imposed by the United States, United Kingdom, European Union, and other countries on Russia, Belarus, and occupied regions in Ukraine have negatively impacted our results from operations in the region.
That investigation had stemmed from the Company’s Rx Pharmaceuticals business, which was divested in 2021. 39 Perrigo Company plc - Item 7 Executive Overview Restructuring Supply Chain Reinvention Program In 2022, we initiated a Supply Chain Reinvention Program to reduce structural costs, improve profitability and our service levels to our retail partners, and strengthen our resiliency by streamlining and simplifying our global supply chain.
Restructuring Supply Chain Reinvention Program In 2022, we initiated a Supply Chain Reinvention Program to reduce structural costs, improve profitability and our service levels to our retail partners, and strengthen our resiliency by streamlining and simplifying our global supply chain.
The cash flow forecasts used for our reporting units include assumptions about future activity levels in the near term and longer-term. If growth in our reporting units is lower than expected, we may experience deterioration in our cash flow forecasts that may indicate goodwill in one or more reporting units is impaired in future impairment tests.
If growth in our reporting units is lower than expected, we may experience deterioration in our cash flow forecasts that may indicate goodwill in one or more reporting units is impaired in future impairment tests. An increase in the discount rate could negatively impact the estimated fair value of the reporting units and lead to future impairment.
As such, we continue to evaluate the impact of the above factors on liquidity and may determine that modifications to our capital structure are appropriate if market conditions deteriorate, favorable capital market opportunities become available, or any change in conditions relating to the war in Ukraine and conflicts in the Middle East, inflation and interest rates, the status of material contingent liabilities, financial market volatility or other uncertainties have a material impact on our capital requirements. 46 Perrigo Company plc - Item 7 Financial Condition, Liquidity and Capital Resources Cash, Cash Equivalents and Restricted Cash Year Ended (in millions) December 31, 2024 December 31, 2023 Cash, cash equivalents and restricted cash (1) $ 558.8 $ 751.3 Working capital (2) $ 915.3 $ 935.9 (1) We had $7.0 million of restricted cash on the Consolidated Balance Sheets as of December 31, 2023.
As such, we continue to evaluate the impact of the above factors on liquidity and may determine that modifications to our capital structure are appropriate if market conditions deteriorate, favorable capital market opportunities become available, or any change in conditions relating to the war in Ukraine and conflicts in the Middle East, a government shutdown in the United States or elsewhere, inflation and interest rates, the status of material contingent liabilities, financial market volatility, tariffs, potential tariff and trade policies or other uncertainties have a material impact on our capital requirements.
For results by segment and geographic locations see below Segment Results and Item 8. Note 2 and Note 20 . Recent Developments Market Factors and Trends Economic Uncertainty Current macroeconomic conditions remain very dynamic, including impacts from inflation and interest rates, volatile changes in foreign currency exchange rates, political unrest and uncertainty and legislative and regulatory changes.
Market Factors and Trends Macroeconomic Uncertainty Current macroeconomic conditions remain dynamic, including impacts from inflation and interest rates, volatile changes in foreign currency exchange rates, tariffs and other trade restrictions, political unrest and uncertainty and legislative and regulatory changes.
As previously disclosed, the Company received a warning letter from the FDA on August 30, 2023 relating to the Perrigo Wisconsin infant formula facility, which was acquired from a third party in November 2022.
Together, these measures may introduce new compliance and regulatory obligations and may affect competitive dynamics in the U.S. market. As previously disclosed, we received a warning letter from the FDA on August 30, 2023 relating to the Perrigo Wisconsin infant formula facility, which we acquired in November 2022.
Investments in and the equity in earnings of non-guarantor subsidiaries, which would otherwise be consolidated in accordance with U.S.
Investments in and the equity in earnings of non-guarantor subsidiaries, which would otherwise be consolidated in accordance with U.S. GAAP, are excluded from the below summarized financial information pursuant to SEC Regulation S-X Rule 13-01.
However, future supply chain disruptions and inflationary pressures from the continuation of the conflicts between Russia and Ukraine and any escalating conflicts in the Middle East and neighboring regions are uncertain.
However, future supply chain disruptions and inflationary pressures from the continuation of the conflicts between Russia and Ukraine, any escalating conflicts in the Middle East, persistent geopolitical tensions and the impact of tariff and trade policy are uncertain. Foreign Exchange We have both translation and transaction exposure to the fluctuation of exchange rates.
For information on our operating and finance lease obligations and the amount and timing of future payments refer to Item 8. Note 8 . Available Resources We have overdraft facilities available that we use to support our cash management operations. We report any balances outstanding in "Other Financing" in Item 8. Note 12 .
Available Resources We have overdraft facilities available that we use to support our cash management operations. We report any balances outstanding in "Other Financing" in Item 8. Note 13 . There were no borrowings outstanding under the overdraft facilities as of December 31, 2025 and December 31, 2024.
On December 15, 2023, we and the Borrower entered into Amendment No. 1, an Incremental Assumption Agreement (the "Amendment") to the Credit Agreement.
On December 15, 2023, we and the Borrower entered into Amendment No. 1 and Incremental Assumption Agreement (the "Amendment") to the Credit Agreement. The Amendment provided for a fungible add on to the 2022 Term B Loans in an aggregate principal amount of $300.0 million (the "2023 Incremental Term B Loans").
Two key initiatives are fundamental to advancing our self-care strategy — our Supply Chain Reinvention Program, a global supply chain efficiency program, and Project Energize, a global investment and efficiency program. In addition, we continue to invest in other initiatives, including innovation, information systems and tools, and our people to drive consistent and sustainable results.
In addition, we continue to invest in other initiatives, including innovation, information systems and tools, and our people to drive consistent and sustainable results.
In December 2024, we and the Borrower entered into Amendment No. 2, an Incremental Assumption Agreement to our Term Loan and Revolving Credit Agreement that provides for the refinancing of the Term B Loans outstanding under the Credit Agreement in the aggregate principal amount of $984.7 million. Refer to Item 8.
On December 15, 2024, we and the Borrower entered into Amendment No. 2 to the Credit Agreement, which established a new tranche of loans under the Term B Facility (the "Term B Loans") and which refinanced all of the 2023 Incremental Term B Loans and the 2022 Term B Loans outstanding under the Credit Agreement in the aggregate amount of $984.7 million.
These decreases were partially offset by impairment charges of $38.6 million, higher restructuring costs and higher advertising and promotion compared to the prior year, primarily for Opill ® . 43 Perrigo Company plc - Item 7 CSCI CONSUMER SELF-CARE INTERNATIONAL Segment Financial Results Year Ended (in millions, except percentages) December 31, 2024 December 31, 2023 Net sales $ 1,679.6 $ 1,693.3 Gross profit $ 763.5 $ 772.0 Gross profit % 45.5 % 45.6 % Operating income (loss) $ 105.0 $ (35.2) Operating income % 6.3 % (2.1) % Net sales decreased $13.7 million, or 0.8% primarily due to: • $50.6 million decrease from the divestiture of the Rare Diseases and Hospital and Specialty Businesses and the sale of branded products; and • $10.0 million decrease from unfavorable foreign currency translation; partially offset by • $46.9 million, or 2.9%, net increase due primarily to approximately $154 million of strategic pricing actions and new products, partially offset by lower net sales across most product categories, primarily Upper Respiratory due to lower cough cold and allergy seasonal demand compared to the prior year.
CONSUMER SELF-CARE INTERNATIONAL Segment Financial Results Year Ended (in millions, except percentages) December 31, 2025 December 31, 2024 Net sales $ 1,667.7 $ 1,679.6 Gross profit $ 739.7 $ 763.5 Gross profit % 44.4 % 45.5 % Operating income (loss) $ (228.8) $ 105.0 Operating income % (13.7) % 6.3 % Net sales decreased $11.9 million, or 0.7% primarily due to: • $66.5 million decrease due to the prior year divestitures of the Rare Diseases Business and the Hospital & Specialty Business and the sale of branded products; partially offset by • $50.4 million increase from favorable foreign currency translation.
Gross profit as a percentage of net sales decreased 80 basis points compared to the prior year due to the same factors that impacted gross profit; and • $98.7 million decrease in operating expenses due primarily to lower selling and administrative costs of $149.4 million due primarily to Project Energize and lower variable employee costs.
Gross profit as a percentage of net sales decreased 110 basis points compared to the prior year due to the same factors that impacted gross profit; and • $310.0 million increase in operating expenses driven by the $407.1 million goodwill impairment charge.
The discount 53 Perrigo Company plc - Item 7 Critical Accounting Estimates rates used in testing each of our reporting units’ goodwill for impairment during our testing were based on the weighted average cost of capital determined for each of our reporting units.
The discount rates used in testing each of our reporting units’ goodwill for impairment during our testing were based on the weighted average cost of capital determined for each of our reporting units. In our impairment test as of December 31, 2025, discount rates ranged from 11.00% to 11.50%, and perpetual growth rates were 2.50%.
These dynamics were partially offset by higher net sales of Vitamax ; • Women's Health : Net sales of $132.8 million increased 11.0%, inclusive of a 0.3% unfavorable effect of currency translation, due primarily to higher net sales of contraceptive products including ellaOne ® , driven by market share gains and the absence of prior year distribution transitions; • Oral Care: Net sales of $99.4 million decreased 2.0% inclusive of a 1.2% favorable effect of currency translation, due primarily to lower net sales of store brand oral care products and Plackers ® ; • Digestive Health and Other: Net sales of $133.8 million decreased 19.6%, inclusive of a 0.4% favorable effect of currency translation, due primarily to the divestiture of the Rare Diseases Business, partially offset by higher net sales of store brand digestive health products.
These were partially offset by improved supply of key products, including the Physiomer ® brand; • Pain & Sleep-Aids: Net sales of $235.4 million increased 6.0%, inclusive of a 4.0% favorable effect of currency translation, due primarily to restored supply of the Solpadeine ® brand; • Healthy Lifestyle: Net sales of $231.5 million increased 2.5%, inclusive of a 0.6% favorable effect of currency translation, due primarily to new products in the Jungle Formula ® franchise; • VMS : Net sales of $161.2 million decreased 7.1%, inclusive of a 3.9% favorable effect of currency translation, due primarily to reduced strategic focus on nutraceutical products within the category; • Women's Health : Net sales of $143.5 million increased 8.0%, inclusive of a 4.2% favorable effect of currency translation, due primarily to market share gains in ellaOne ® ; • Oral Care: Net sales of $97.5 million decreased 2.0% inclusive of a 3.9% favorable effect of currency translation, due primarily to lower net sales of store brand products; and • Digestive Health and Other: Net sales of $102.7 million decreased 23.2%, inclusive of a 2.1% favorable effect of currency translation, due primarily to the divestiture of the Rare Diseases Business, partially offset by higher net sales of store brand digestive health products.
Through this initiative, we are reducing portfolio complexity, investing in advanced planning capabilities, diversifying sourcing, and optimizing our manufacturing assets and distribution models. We estimate a total annual run-rate potential savings opportunity by the end of fiscal year 2028 of between $200 million to $300 million (not including related depreciation expense on capital investments).
Through this initiative, we have reduced portfolio complexity, invested in advanced planning capabilities, diversified sourcing, and optimized our manufacturing assets and distribution models. The program objectives are now realized with approximately $157 million of annualized benefits (not including related depreciation expense on capital investments) achieved by the end of fiscal year 2025.
Cash Flows The following table includes summarized cash flow activities: Year Ended (in millions) December 31, 2024 December 31, 2023 $ Change Net cash from operating activities $ 362.9 $ 405.5 $ (42.6) Net cash from (for) investing activities 78.8 (77.5) 156.3 Net cash from (for) financing activities (611.0) (187.2) (423.8) Effect of exchange rate changes on cash and cash equivalents (23.2) 9.8 (33.0) Net increase (decrease) in cash and cash equivalents $ (192.5) $ 150.6 $ (343.1) Net cash from Operating Activities The $42.6 million decrease in operating cash inflow was primarily driven by a decrease in cash flow from the change in net earnings after adjustments including deferred income taxes, restructuring charges, settlement of interest rate derivatives, the gain on sale of branded products in addition to higher working capital, primarily related to restructuring costs.
Cash Flows The following table includes summarized cash flow activities: Year Ended (in millions) December 31, 2025 December 31, 2024 $ Change Net cash from operating activities $ 238.5 $ 362.9 $ (124.4) Net cash (for) from investing activities (75.4) 78.8 (154.2) Net cash for financing activities (220.5) (611.0) 390.5 Effect of exchange rate changes on cash and cash equivalents 32.5 (23.2) 55.7 Net decrease in cash and cash equivalents $ (24.9) $ (192.5) $ 167.6 Net cash from Operating Activities The $124.4 million decrease in operating cash inflow was primarily driven by a decrease in cash flow from the change in net earnings after adjustments for items including impairment, depreciation and amortization, and restructuring. 47 Perrigo Company plc - Item 7 Financial Condition, Liquidity and Capital Resources Net cash (for) from Investing Activities The $154.2 million decrease in cash from investing cash flow was due primarily to the absence of the proceeds from the sale of the Rare Diseases and Hospital & Specialty Businesses and the six branded products in the prior year period.
Perrigo’s unique complementary businesses enables each individually to play a specific reinforcing role, where 1) store brands and infant formula generate cash for investments into the Company’s key higher margin, higher growth or ‘High-Grow’ brands, 2) branding and innovation capabilities that deliver brand and store brand demand generation leading to stronger customer partnerships, 3) consumer-led innovation that is scaled across brands, store brands and geographies, and 4) the Company’s global supply chain scale and reach with 100-plus molecules, at 100% consumer price point coverage, serves the most consumers.
Perrigo’s unique complementary businesses enable each individually to play a specific reinforcing role, where 1) store brands generate cash for investments into the Company’s key higher margin, higher growth brands, 2) branding and innovation capabilities deliver both brand and store brand demand generation designed to lead to stronger customer partnerships, 3) consumer-led innovation scaled across brands, store brands and geographies, and 4) leveraging global supply chain scale of more molecules at more price points to more consumers driving household penetration. 37 Perrigo Company plc - Item 7 Executive Overview The Company’s plan to drive cash flow and total shareholder return is anchored behind its ‘Three-S’ plan – ‘Stabilizing’ Consumer Self-Care Americas store brand and infant formula businesses; ‘Streamlining’ the global portfolio, enterprise operating model and Consumer Self-Care International business; and ‘Strengthening’ what is working by prioritizing and increasing investments behind key brands.
Operating income increased $140.2 million, or 398.3%, due to: • $8.5 million decrease in gross profit due primarily to the impact of lower net sales volumes of $85.5 million, divested businesses and exited product lines of approximately $34 million, and negative impacts from cost of goods sold inflation.
Operating income decreased $333.8 million, or 317.9%, due to: • $23.8 million decrease in gross profit due primarily to the impact of divested businesses and exited products of $41.6 million, lower global OTC sales volumes, and unfavorable costs of goods sold inflation.
Future business results may affect deferred tax liabilities or the valuation of deferred tax assets over time. For the year ended December 31, 2024, we recorded a net increase in valuation allowances of $47.7 million comprised primarily of additional valuation allowance on certain non-deductible interest carryforward assets, which are no longer realizable.
Future business results may affect deferred tax liabilities or the valuation of deferred tax assets over time. For the 52 Perrigo Company plc - Item 7 Critical Accounting Estimates year ended December 31, 2025, we recorded a net increase in valuation allowances of $129.9 million primarily related to the change in realizability of our deferred tax assets in the U.S.
If we consummate certain qualifying acquisitions during the term of the loan, the maximum first lien secured net leverage ratio covenant would increase to 3.25 to 1.00 for such quarter and the three following fiscal quarters thereafter. 49 Perrigo Company plc - Item 7 Financial Condition, Liquidity and Capital Resources Leases We had $195.1 million and $202.2 million of lease liabilities and $186.9 million and $197.3 million of lease assets as of December 31, 2024 and December 31, 2023, respectively.
If we consummate certain qualifying acquisitions during the term of the loan, we can elect to increase the maximum first lien secured net leverage ratio to 3.25 to 1.00 for the quarter in which the acquisition occurs and the three following fiscal quarters thereafter.
As of December 31, 2024, we were in compliance with all such covenants under our debt agreements. Credit Ratings Our credit ratings on December 31, 2024 were Ba2 (negative), BB- (stable), and BB (negative), by Moody's Investor Services, S&P Global Ratings ("S&P"), and Fitch Ratings Inc. ("Fitch"), respectively.
Credit Ratings Our credit ratings on December 31, 2025 were Ba3 (stable), BB- (stable), and BB (stable), by Moody's Investor Services, S&P Global Ratings ("S&P"), and Fitch Ratings Inc. ("Fitch"), respectively. On December 12, 2025, Moody's Investor Services downgraded our issuer credit rating to Ba3 from Ba2 and adjusted the rating outlook to stable.
CONSOLIDATED Consolidated Financial Results Year Ended (in millions, except percentages) December 31, 2024 December 31, 2023 Net sales $ 4,373.4 $ 4,655.6 Gross profit $ 1,542.7 $ 1,680.4 Gross profit % 35.3 % 36.1 % Operating income $ 112.9 $ 151.9 Operating income % 2.6 % 3.3 % Net sales decreased $282.2 million, or 6.1%, primarily due to: • $206.1 million decrease, or 4.5%, due primarily to $179.2 million of lower net sales volumes, previously disclosed lost distribution of lower margin products, and a later start to the cough and cold season, primarily impacting the Pain & Sleep Aids, Upper Respiratory Digestive Health, and Oral Care categories compared to the prior year and $108.4 million of lower net sales in U.S.
CONSOLIDATED Consolidated Financial Results Year Ended (in millions, except percentages) December 31, 2025 December 31, 2024 Net sales $ 4,253.1 $ 4,373.4 Gross profit $ 1,494.5 $ 1,542.7 Gross profit % 35.1 % 35.3 % Operating income (loss) $ (1,122.2) $ 112.9 Operating income % (26.4) % 2.6 % Net sales decreased $120.3 million, or 2.8%, primarily due to: • $103.6 million decrease, or 2.4%, driven by lower net sales of $51.5 million in Digestive Health , lower net sales of $41.0 million in Nutrition primarily due to infant formula , lower net sales in Oral Care, and the absence of the prior-year Opill ® launch stocking benefit of $15.0 million.

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Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeBuybacks of our ordinary shares could affect the market price of our ordinary shares, increase their volatility or diminish our cash reserves, which may impact our ability to finance future growth and to pursue possible future strategic opportunities and acquisitions.
Biggest changeNo share repurchases are currently anticipated in the near term. 30 Perrigo Company plc - Item 1A Risk Factors Buybacks of our ordinary shares could affect the market price of our ordinary shares, increase their volatility or diminish our cash reserves, which may impact our ability to finance future growth and to pursue possible future strategic opportunities and acquisitions.
During the years ended December 31, 2024 and December 31, 2023, we did not repurchase any shares under such authorization, and there can be no assurances that we will do so in the future.
During the years ended December 31, 2025 and December 31, 2024, we did not repurchase any shares under such authorization, and there can be no assurances that we will do so in the future.
On July 18, 2023, the Irish High Court approved the creation of $4,900 million of distributable reserves of the Company through the reduction of the Share Premium account. The court order authorizing the creation of distributable reserves was filed with the Registrar of Companies in Ireland and became effective on July 20, 2023.
On July 18, 2023, the Irish High Court approved the creation of $4.9 billion of distributable reserves of the Company through the reduction of the Share Premium account. The court order authorizing the creation of distributable reserves was filed with the Registrar of Companies in Ireland and became effective on July 20, 2023.
The Act differs in some material respects from laws generally applicable to U.S. corporations and shareholders, including the provisions relating to interested directors, mergers, amalgamations and acquisitions, takeovers, shareholder lawsuits, and indemnification of directors. 31 Perrigo Company plc - Item 1A Risk Factors • Under Irish law, the duties of directors and officers of a company are generally owed to the company only.
The Act differs in some material respects from laws generally applicable to U.S. corporations and shareholders, including the provisions relating to interested directors, mergers, amalgamations and acquisitions, takeovers, shareholder lawsuits, and indemnification of directors. • Under Irish law, the duties of directors and officers of a company are generally owed to the company only.
Additionally, we are subject to financial covenants in our Senior Secured Credit Facilities. Our failure to comply with these covenants could trigger events, which could result in the acceleration of the related debt. Refer to Item 7. Management's Discussion and Analysis - Capital Resources for more information.
Additionally, we are subject to financial covenants in our Senior Secured Credit Facilities. Our failure to comply with these covenants could trigger events, which could result in the acceleration of the related debt. Refer to Item 7. Management's Discussion and Analysis - Capital Resources for more information. ITEM 1B. UNRESOLVED STAFF COMMENTS Not applicable. ITEM 1C.
These provisions may give the Board of Directors less ability to control negotiations with hostile offerors and protect the interests of holders of ordinary shares than would be the case for a corporation incorporated in a jurisdiction of the United States. We may be limited in our ability to pay dividends in the future.
These provisions may give the Board of Directors less ability to control negotiations with hostile offerors and protect the interests of holders of ordinary shares than would be the case for a corporation incorporated in a jurisdiction of the United States. 31 Perrigo Company plc - Item 1A Risk Factors We may be limited in our ability to pay dividends in the future.
In addition, our ability to repurchase shares may be limited in the future under Irish law, if at any time we do not have sufficient distributable reserves. No share repurchases are currently anticipated in the near term.
In addition, our ability to repurchase shares may be limited in the future under Irish law, if at any time we do not have sufficient distributable reserves.
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CYBERSECURITY RISK MANAGEMENT AND STRATEGY Cybersecurity is an important part of our risk management program and an area of increasing focus for our Board of Directors and management. We use a risk-based approach to identify, assess, protect, detect, respond to and recover from cybersecurity threats.
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While management is responsible for the day-to-day risk management, the Board of Directors, is responsible for the Company's overall risk oversight function, including cybersecurity risks. The Nominating & Governance Committee ("NGC") supports the Board of Directors by overseeing cybersecurity risks, policies and objectives.
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The Audit Committee supports the Board of Directors in overseeing the framework for risk assessments and enterprise risk management ("ERM") process. The Company’s cybersecurity policies, standards and processes are designed and implemented in light of the requirements of the National Institute of Standards and Technology ("NIST") frameworks for cybersecurity and privacy.
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Recognizing that no single technology, process or business control can effectively prevent or mitigate all risks, we employ multiple technologies, processes and controls, all working as part of a cohesive strategy to minimize risk including the following: • We emphasize security and resiliency through business assurance capabilities and incident response plans designed to identify, evaluate, and remediate incidents when they occur.
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We regularly review and update our plans, policies and technologies and conduct regular training exercises and crisis management preparedness activities to test their effectiveness. • Perrigo leverages the NIST cybersecurity framework to measure the capability of its cybersecurity program and we conduct third party assessments to measure the NIST ratings. • We maintain a cybersecurity risk register which is reviewed periodically with relevant stakeholders.
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Risks that are higher in impact are included within our Enterprise Risk Register which is reviewed with Executive Leadership and the Board of Directors. • Our processes used to identify, assess, protect, detect, respond to and recover from cybersecurity threats are regularly tested by external parties through penetration testing, and other exercises designed to assess and test our cybersecurity health, resiliency and the effectiveness of our program. 32 Perrigo Company plc - Item 1C Cybersecurity • Management invests in organization capability and technology to manage and identify cybersecurity and information security risks.
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Our Company has information security employees across the globe, enabling us to monitor and promptly respond to threats and incidents, identify and maintain oversight of cybersecurity risks associated with third parties, evaluate and deploy cybersecurity technologies, and educate associates on cybersecurity risks. • We maintain cyber insurance coverage to help mitigate possible costs associated with a potential incident. • We have implemented an information and cybersecurity awareness program designed to educate and test employee maturity at least annually, and regularly throughout the year employees receive training regarding phishing and other threat actor schemes, the inherent risks involved in human interaction with information and operational technology, and new and emerging technologies.
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We have processes in place designed to allow us to oversee and identify risks from cybersecurity threats associated with our use of third-party service providers and suppliers through our Supplier Cyber Risk Assessment process, which assesses third-party cybersecurity controls through a combination of risk assessment questionnaires, commercially available risk data and security rating platforms.
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We also include cybersecurity and information security language in our contracts where applicable. We require our suppliers and partners to report cybersecurity incidents to us so that we can assess the impact of such an incident on us and have dedicated processes to respond to cybersecurity incidents at third parties.
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We have established processes to contain the impact of potential security incidents on Perrigo's third-party service providers. As of December 31, 2025 , we are unaware of any risks from cybersecurity threats (including previous cybersecurity incidents) that may have materially affected or are reasonably likely to materially affect the Company's business strategy, results of operations or financial condition.
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We have experienced and may continue to experience cybersecurity incidents; however, w e do not believe any cybersecurity incidents incurred to date have materially affected our Company, including our business strategy, results of operations, or financial condition.
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While we continue to employ resources to monitor our systems and protect our infrastructure, these measures may prove insufficient, and that could subject us to significant risks.
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For further discussion of how these and other potential cybersecurity risks may impact our business, refer to the risk factor under heading “ A cybersecurity breach, disruption or misuse of our information systems, or our external business partners’ information systems could have a material adverse effect on our business” in Item 1A. Risk Factors – Operational Risks .
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GOVERNANCE Our overall information security efforts are led by the Chief Information Security Officer ("CISO"). The CISO has substantial experience in cybersecurity, including knowledge, skills, certifications, and background in the field. The CISO holds several key certifications including Certified Information Systems Security Professional ("CISSP"), Certified Secure Software Lifecycle Professional ("CSSLP") and Certified Ethical Hacker ("CeH").
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While management is responsible for day-to-day risk management, the Board of Directors is responsible for the Company’s overall risk oversight function, including cybersecurity risks, and includes oversight by several committees. The NGC, comprised solely of independent directors, supports the Board of Directors by overseeing cybersecurity risks, policies and objectives.
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As a part of its duties, the NGC regularly provides reports to the full Board of Directors. The NGC routinely engages with the CFO, the CISO and Chief Technology Officer on a range of cybersecurity-related topics, including threats to the environment and vulnerability assessments, policies and practices, technology trends and regulatory developments.
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The NGC conducts regular committee meetings prior to each regular Board of Directors meeting and convenes additional sessions as necessary to address a specific cybersecurity threat. Perrigo has an incident response team comprised of the CISO and senior leadership from Legal, Human Resources and Finance. We have a formalized breach management protocol and playbooks that are tested periodically.
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Perrigo uses a panel of forensic and third-party service providers to assist the Company with its response in the event of a cybersecurity incident. We employ escalation procedures designed to notify management of certain specific cybersecurity threats or incidents.
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If deemed appropriate, management will notify the NGC, which may convene to discuss the cybersecurity threat before reporting to the Board of Directors on the matter. 33 Perrigo Company plc - Item 2

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeInterest Rate Risk We are exposed to interest rate changes primarily as a result of interest income earned on our investment of cash on hand and interest expense on borrowings. We have in the past, and may in the future, enter into certain derivative financial instruments related to the management of interest rate risk, when available on a cost-effective basis.
Biggest changeWe have in the past, and may in the future, enter into certain derivative financial instruments related to the management of interest rate risk, when available on a cost-effective basis. These instruments are managed on a consolidated basis to efficiently net exposures and thus take advantage of any natural offsets.
We estimate the translation effect of a ten percent devaluation of the U.S. dollar relative to the other foreign currencies in which we transact business would not materially affect operating income of our non U.S. operating units for the year ended December 31, 2024. This sensitivity analysis has inherent limitations.
We estimate the translation effect of a ten percent devaluation of the U.S. dollar relative to the other foreign currencies in which we transact business would not materially affect operating income of our non U.S. operating units for the year ended December 31, 2025. This sensitivity analysis has inherent limitations.
In certain markets, we could recognize a significant gain or loss related to unrealized cumulative translation adjustments if we were to exit the market and liquidate our net investment. As of December 31, 2024, cumulative net currency translation adjustments decreased shareholders’ equity by $196.0 million. We monitor and strive to manage risk related to foreign currency exchange rates.
In certain markets, we could recognize a significant gain or loss related to unrealized cumulative translation adjustments if we were to exit the market and liquidate our net investment. As of December 31, 2025, cumulative net currency translation adjustments increased shareholders’ equity by $9.3 million. We monitor and strive to manage risk related to foreign currency exchange rates.
Our largest exposure is the movement of the U.S. dollar relative to the euro. 54 Perrigo Company plc - Item 7A Due to different sales and cost structures, certain segments experience a negative impact and certain segments a positive impact as a result of changes in exchange rates.
Our largest exposure is the movement of the U.S. dollar relative to the euro. Due to different sales and cost structures, certain segments experience a negative impact and certain segments a positive impact as a result of changes in exchange rates.
Refer to Item 8. Note 1 and Note 11 for further information regarding our derivative instruments and hedging activities. 55 Perrigo Company plc - Item 8
Refer to Item 8. Note 1 and Note 12 for further information regarding our derivative instruments and hedging activities. 56 Perrigo Company plc - Item 8
Exposures that cannot be naturally offset within a local entity to an immaterial amount are often hedged with foreign exchange derivatives or netted with offsetting exposures at other entities. We cannot predict future changes in foreign currency movements and fluctuations that could materially impact earnings.
Exposures that cannot be naturally offset within a local entity to an immaterial amount are often hedged with foreign exchange derivatives or netted with offsetting exposures at other entities.
A 1% increase in interest rates would result in approximately $2.3 million of additional annual interest expense in 2025. Inflation Risk Inflationary factors such as increases in the cost of our products and overhead costs may adversely affect our operating results.
Inflation Risk Inflationary factors such as increases in the cost of our products and overhead costs may adversely affect our operating results.
These instruments are managed on a consolidated basis to efficiently net exposures and thus take advantage of any natural offsets. Gains and losses on hedging transactions are offset by gains and losses on the underlying exposures being hedged. We do not use derivative financial instruments for speculative purposes.
Gains and losses on hedging transactions are offset by gains and losses on the underlying exposures being hedged. We do not use derivative financial instruments for speculative purposes. A 1% increase in interest rates would result in approximately $2.3 million of additional annual interest expense in 2026.
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We cannot predict future changes in foreign currency movements and fluctuations that could materially impact earnings. 55 Perrigo Company plc - Item 7A Interest Rate Risk We are exposed to interest rate changes primarily as a result of interest income earned on our investment of cash on hand and interest expense on borrowings.

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