PERRIGO Co plc (PRGO) Business

Business

PART I.

ITEM 1.    BUSINESS

Perrigo Company plc was incorporated under the laws of Ireland on June 28, 2013 and became the successor registrant of Perrigo Company, a Michigan corporation, on December 18, 2013 in connection with the acquisition of Elan Corporation, plc ("Elan"). Unless the context requires otherwise, the terms "Perrigo," the "Company," "we," "our," "us," and similar pronouns used herein refer to Perrigo Company plc, its subsidiaries, and all predecessors of Perrigo Company plc and its subsidiaries.

WHO WE ARE

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. As one of the originators of the over-the-counter ("OTC") self-care market, Perrigo is led by its vision "To Provide The Best Self-Care For Everyone" and its purpose to "Make Lives Better Through Trusted Health and Wellness Solutions, Accessible To All".

Perrigo works to fulfill its vision and purpose as a top-tier consumer self-care company with a focused portfolio based on consumer-led innovation, which meets societal needs for:

•Access: Perrigo's self-care products and solutions enhance the daily lives of millions of families, empowering them to take control of their health and wellness.

•Value: Perrigo delivers value by helping consumers proactively manage their well-being through affordable and effective self-care solutions.

•Reliability: Perrigo ensures the safety and effectiveness of its self-care solutions, best serving its consumers.

Perrigo provides access to trusted self-care solutions that can be used without the need to visit a health practitioner for a prescription. Guided by our vision and purpose, our strategic goal is to create sustainable and value accretive growth by 1) delivering consumer preferred brands and innovation, 2) driving category growth with our customers, 3) powering our business with our world-class, quality assured supply chain, including a focus on sustainability with meaningful goals to reduce greenhouse gas emissions, water, and waste, in addition to increasing the recyclability of our packaging, and 4) evolving our global organization to one cohesive operating model. Our unique competency is to deliver health and wellness solutions across multiple price and value tiers that improve access and choice for consumers.

Perrigo's broad offerings are well diversified across several major product categories as well as across geographies, primarily in North America and Europe, with no one product representing more than 5% of total revenue. 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®. In Europe, our portfolio consists primarily of brands, including Compeed®, ellaOne®, Solpadeine®, Jungle Formula®, and ACO®.

Two key initiatives have been fundamental in 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.

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.

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. Further 2025 highlights can be found in Item 7. Management Discussion and Analysis - Executive Overview.

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Strategy & Competitive Advantage

Our objective is to grow our business by responsibly leveraging our global infrastructure to deliver high quality self-care solutions to customers and consumers through our expansive product offerings, providing new innovative products, brands, and product line extensions to consumers through entering new adjacent products and categories, new geographies and new channels of distribution organically and inorganically.

Among other elements, we believe the following factors give us a competitive advantage and provide value to our customers and consumers:

•A diverse product portfolio, leadership in first-to-market product development, and product life cycle management;

•Experienced research and development ("R&D"), innovation and regulatory capabilities to develop and launch high-quality solutions, differentiated product and packaging features, product reformulations, and new brands and brand line extensions;

•Deep understanding of consumer needs and customer strategies with market, category and product specific promotional and e-commerce capabilities;

•Expansive global commercial infrastructure, brand-building capabilities, and an extensive and diverse product portfolio to leverage our ability to deliver hundreds of molecules at multiple price points;

•Supply chain breadth, and utilizing economies of scale to manage supply chain complexity across multiple dosage forms, formulations, stock-keeping units and geographies; and

•Quality and cost effectiveness throughout the supply chain and operational systems across all products creating a sustainable, lower-cost network across our manufacturing and distribution networks.

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. Our reporting and operating segments are:

•Consumer Self-Care Americas ("CSCA") comprises our consumer self-care business in the U.S. and Canada.

•Consumer Self-Care International ("CSCI") comprises our consumer self-care business outside of the U.S. and Canada, primarily in Europe and Australia.

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. 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.

We previously had a "prescription only" ("Rx") segment comprised of our generic prescription pharmaceuticals business in the U.S. and other pharmaceuticals and diagnostic businesses in Israel, which have been divested. The Rx segment was reported as Discontinued Operations in 2021, and is presented as such for all periods in this report. See Item 8. Note 5 for more information. Financial information related to our business segments can be found in Item 8. Note 21.

CONSUMER SELF-CARE AMERICAS

The CSCA segment develops, manufactures and markets our leading self-care consumer solutions in the U.S. and Canada. We primarily provide our customers self-care products that are sold and marketed under the customer's own brands and/or exclusive brands ("store brands"). We also own, market and sell to consumers and customers a select lineup of branded self-care products. Customers include major global, national, and regional retail drug, supermarket, mass merchandise chains, e-commerce retailers, and major wholesalers.

Our store brand products are comparable in quality and effectiveness to national brands. Store brand products must meet the same stringent U.S. Food and Drug Administration ("FDA") requirements as national brands within the U.S. and the requirements of comparable regulatory bodies outside the U.S. In most instances, our product packaging, marketing, advertising, and e-commerce focus are designed to invite and reinforce comparison to national brand products, while conveying a superior value for consumers. The cost of store brand products to retailers is significantly lower than that of comparable nationally advertised brand name products. The retailer, therefore, can price a store brand product below the competing national brand product and realize a greater percentage and dollar profit, while consumers benefit from receiving a high-quality product at a price below the

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comparable national brand product. Consumer awareness and knowledge of the quality, value and efficacy of our products are achieved from marketing efforts made by us, our retailer customers and wholesalers.

Certain branded products are developed, manufactured and distributed within the CSCA segment. Our primary branded products sold under brand names include Compeed®, Dr. Fresh®, Firefly®, Good Sense®, Good Start®, Mederma®, Nasonex®, Plackers®, Prevacid®24HR, REACH®, Rembrandt®, Steripod® and Opill®.

CONSUMER SELF-CARE INTERNATIONAL

The CSCI segment comprises our consumer self-care product categories outside the U.S. and Canada, primarily our branded products in Europe and Australia and our store brand products in the United Kingdom and parts of Europe and Asia. We leverage our broad marketing, sales, regulatory, manufacturing and distribution infrastructure to drive market share, innovate new products and brands, in-license and expand product lines, and sell and distribute third-party brands. The CSCI segment products are sold primarily through an established pharmacy sales force to an extensive network of customers including pharmacies, wholesalers, drug and grocery store retailers, e-commerce retailers, and para-pharmacies in more than 30 countries, predominantly in Europe. Branded products in the CSCI segment are marketed using traditional and digital advertising as well as point-of-sale promotional spending to enhance brand equity.

While we have hundreds of brands, we focus our resources on growth brands, including Solpadeine®, Coldrex®, Physiomer®, Jungle Formula®, NiQuitin®, Compeed®, and ellaOne®. Many of these brands have leading positions in the markets in which they compete. We focus our resources, including R&D investments, to these brands to strengthen their market position while leveraging the same R&D efforts for local brands. Our new product pipeline is supported by internal R&D, new product development, and acquisitions and partnerships - for both brand extensions and product improvements.

PRODUCTS

We offer products in the following categories:

(1) The Nutrition product category is exclusive to CSCA. Historically, the Nutrition product category included the nutritional beverages product line which was exited during 2023.

(2) Historically, the Other product category included products from our Rare Diseases business which was divested from our CSCI segment in 2024. Refer to Item 8. Note 3 for divestiture details.

New Products

We consider a product to be new if it (i) was reformulated into an additional unique product, (ii) was a product line extension due to changes in characteristics such as strength, flavor, or color, (iii) had a change in product status from "prescription only" ("Rx") to OTC, (iv) was a new store brand or branded launch, (v) was provided in a new dosage form or (vi) was sold to a new geographic area with different regulatory authorities, in all cases, within 12 months prior to the end of the period for which net sales are being measured. Notable new product launches in the year ended December 31, 2025 include Phenylephrine No Drip Nasal Spray, IBU/APAP Dual Active and the TriosTM program launch in CSCA and CSCI line extensions in the Bronchostop® 5 in1 products, flavor roll outs in NiQuitin®, launches of Nasalmer® in new geographic areas. We also had new products in the Physiomer®, Jungle Formula®, Coldrex® and Compeed® franchises. Each of our product categories and growth brands have a three to five-year

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innovation master plan. We rely on both internal R&D and strategic product development agreements with outside sources to develop new products.

SIGNIFICANT CUSTOMERS

Sales to Walmart Inc. represented 12.9% and 11.9% of our consolidated net sales in 2025 and 2024, respectively. While we have other important customers, no other individual customer represents more than 10% of net sales. Our top ten customers accounted for 47% of our total consolidated net sales in 2025 and 2024. We believe we generally have good relationships with our customers. Refer to Item 1A. Risk Factors - Operational Risks for risks associated with customers.

COMPETITION

The markets for our self-care products are highly competitive and differ for each product line, category and geographic region. The competitive landscape of the European consumer products market in the categories in which we compete is more fragmented than the North American market. Our primary competitors include manufacturers, such as Dr. Reddy's Labs, LNK International, Inc., PL Developments, Aurobindo and Sun Pharmaceuticals, and brand-name pharmaceutical and consumer product companies, such as Haleon, Kenvue, Procter & Gamble, Reckitt Benckiser, Abbott Nutrition, Bayer AG, Opella, Philips, Teva, Viatris, and Stada. Each product category of our business has certain key competitors, such that a competitor generally does not compete across all product lines or across all geographic markets. However, some competitors do have larger sales volumes in certain of our categories. Competition is based on a variety of factors, including price, quality, product assortment, customer service, marketing support and approvals for new products. Refer to Item 1A. Risk Factors - Operational Risks for additional information and risks associated with competition.

TRADEMARKS, PATENTS AND LICENSING AGREEMENTS

While we own certain trademarks and patents, neither our business as a whole, nor any of our segments, is materially dependent upon our ownership of any one trademark, or patent, or group of trademarks or patents.

MATERIALS SOURCING

Low cost, high-quality raw materials and packaging components are essential to all of our business units. Some generic raw materials and packaging components are available from multiple suppliers. However, supplies of certain raw materials and packaging components, due to their technical specifications and product delivery systems, are more limited as they may be available from one, or only a few suppliers, and may require extensive compatibility testing before we can use them.

Historically, we have been able to react effectively, yet not always immediately, to situations that require alternate sourcing. Should such alternate sourcing be necessary, FDA requirements placed on products approved through the Abbreviated New Drug Application ("ANDA") or New Drug Application ("NDA") process could substantially lengthen the approval of an alternate source and adversely affect financial results. Additionally, the same sourcing principle holds for other specific regulatory requirements in countries in which we compete. We believe we have good, cooperative working relationships with our suppliers and have historically been able to capitalize on economies of scale in the purchase of materials and supplies due to our volume of purchases. Refer to Item 1A. Risk Factors - Operational Risks for risks associated with materials sourcing. Refer to Item 7. Management's Discussion and Analysis - Executive Overview for a detailed discussion of the impact of inflation and supply chain disruptions, the war in Ukraine, and the Middle East conflicts on our materials sourcing.

MANUFACTURING AND DISTRIBUTION

Our primary manufacturing facilities are in the U.S. We also have manufacturing facilities in the U.K., Belgium, France, Germany and China, along with a joint venture in China. We supplement our production capabilities with the purchase of products from external sources. While our business is not generally seasonal, the capacity of some facilities may not be fully utilized at certain times for various reasons, such as consumer and customer demand, the seasonality of certain product categories (for example, cough/cold/flu and allergy products) and new product launches. We may utilize available capacity by performing contract manufacturing for other companies. We have logistics facilities in the U.S., in numerous locations throughout Europe, and Australia. We use contract freight and common carriers to deliver our products to customers. We also utilize direct-to-consumer platforms to deliver certain offerings to consumers.

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

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chain. Through this initiative, we reduced portfolio complexity, invested in advanced planning capabilities, diversified sourcing, and optimized our manufacturing assets and distribution models. The program was executed over a three-year period and, having achieved its primary objectives, was being finalized as of December 31, 2025. For the remaining project wind-down activities, we anticipate less than $10 million of additional costs to be incurred through fiscal year 2026.

Refer to Item 7. Management's Discussion and Analysis - Executive Overview for a detailed discussion of the impact of inflation and supply chain disruption, and the Supply Chain Reinvention Program on our manufacturing and distribution, and refer to 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. 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. 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. 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. 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.

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. 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. 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. 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. Our intention is to collaborate with suppliers who share our values and responsible practices to make a positive impact on our value chain.

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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. 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. We have made, and continue to make, expenditures necessary to comply with applicable environmental laws; however, we do not believe that the costs for complying with such laws and regulations have been or will be material to our business. We do not have any material remediation liabilities outstanding.

As part of our climate strategy, we're in the process of integrating transitional and physical climate risks into our business strategy and disclosure efforts. We recognize that climate risks may pose potential threats but also offer long term opportunities. We are dedicated to advancing the tools and methodologies for assessing climate impacts, tracking progress in reducing greenhouse gas emissions, and evaluating potential climate-driven risks to our business strategy.

Human Capital Resources

We believe that the support and development of our global colleagues is an important component enabling us to attract, retain, and engage the talent needed to deliver on our self-care strategy. Our global workforce consists of approximately 8,100 full-time and part-time employees spread across 31 countries, of which approximately 17.5% were covered by collective agreements as of December 31, 2025. We continuously endeavor to provide a safe and inclusive work environment so our colleagues can bring their best to work every day. Our vision is clear: “To Provide the Best Self-Care for Everyone”. At Perrigo, our success is not just about reaching these goals; it is about how we get there. The way we work together is foundational. Our Core Values ensure that every decision we each make supports our vision and strengthen our collective impact as One Perrigo. Each global colleague is responsible for upholding Perrigo’s three Core Values of: We Care Deeply, We Do the Right Thing and We Play to Win.

Consistent with our Vision and Core Values, we strive for a world-class and representative workforce that reflects our consumers across the globe, enabling us to continue to provide the best self-care to everyone. We believe that equitable practices and fostering an environment where every individual feels valued, respected and empowered at work creates lasting benefits for our colleagues, customers, consumers, and shareholders and enhances our culture, performance, and profitable growth. Our strategy focuses on building a winning culture through 'belonging' by:

•Educating our workforce to create an environment where every individual feels valued, respected and empowered at work;

•Strengthening our talent management practices through a lens of belonging; and

•Enabling leaders, embedding accountability and strengthening our governance practices.

We are committed to making self-care accessible to all and understand that we can accomplish this by nurturing a culture of belonging where people feel valued, welcomed, respected and heard. Achieving this goal enables our colleagues to deliver their best work and keep our consumers at the center of how we innovate, create, and deliver results. Accordingly, we continue to take action to help ensure our practices, policies, and processes are inclusive and fair for all colleagues. We also strive to support the well-being of the communities we serve and the individuals that make up our team of talented colleagues.

Colleagues at all levels of our Company continually receive educational resources and information on how to best support themselves and foster a culture where every individual feels supported and respected for who they are. Colleagues are encouraged to practice self-care and are provided support resources such as our global Employee Assistance Program which is designed to meet diverse needs of our colleagues across multiple identities, cultures and languages.

Compensation, Benefits, Health, Safety, and Well-being

Perrigo’s commitment to self-care starts with our own team. We are dedicated to maintaining a safe workplace for our team members. As a multi-national company, we are subject to a broad range of local and international laws and regulations relating to occupational safety and health, and our safety program is designed to meet these compliance requirements at a minimum. We also set specific safety standards to proactively identify and manage critical risks to eliminate significant injury and fatality potential in our operations. We continuously evaluate all

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applicable opportunities to reduce risk and provide a safe secure environment and our goal is to create a 100% safe workplace for our team members.

Our Total Rewards philosophy is to continuously attract, retain, and engage our people by designing Total Rewards that reinforce 'belonging' at Perrigo and align with our values and winning culture, helping to drive top tier performance and fulfill Perrigo's Vision. Our Total Rewards package delivers competitive pay, cash-based incentives, broad-based stock grants, retirement benefits, leading healthcare, paid time off, and on-site wellness services, among other benefits. Additionally, we are proud to continue our “HEALTHYyou” well-being program that supports our colleagues and their families in maintaining and improving their health as they navigate their own self-care and well-being journeys. This program is highly valued by our colleagues and it continues to be recognized externally by receiving the Best and Brightest in Wellness™ Award every year since 2017.

Growth, Development, and Engagement

Our One Perrigo culture is a strategic enabler of business performance. By strengthening organizational capability and accelerating talent development, we are building the workforce needed to deliver sustainable growth. This year, we advanced our global framework of core behaviors defining “Perrigo at Our Best” and embedded them across the organization. These behaviors, supported by five developmental levels, provide clear progression pathways and enable data-driven decisions in hiring, onboarding, and development. This approach is designed to ensure equity and transparency while aligning talent growth with business priorities.

Employee engagement remains central to our strategy. We have implemented more structured communications and feedback mechanisms and tools to support leaders to connect individuals to our strategy. We enhanced our development philosophy by deepening the partnership between colleagues and managers supported by annual career conversations to match individual aspirations to organizational needs. Our robust talent identification process now better matches high-potential colleagues with critical roles, ensuring we have the right capabilities in place to execute our strategy. These initiatives strengthen our culture, improve engagement and retention, and create a pipeline of leaders who will drive long-term value for shareholders.

We also empower colleagues to take control of their own development by providing access to our 'GROWyou' personal development curriculum. This curriculum is supplemented by offering colleagues 24/7 access to on-demand self-study content. Personal development and learning are guided by ongoing conversations and feedback as part of our performance management philosophy.

We continue to invest in our leadership capability at all levels in the organization so they can provide the right environment within our culture to engage, grow and develop our colleagues.

We also want to ensure that colleagues can connect their daily work to our vision, purpose and strategy. We do this through regular global, functional and local townhalls and round table discussions with senior leaders. This gives colleagues an opportunity to stay up to date, share their views and to get their questions answered. We also run regular engagement surveys to take feedback from the organization and convert that feedback into meaningful action to build a winning culture.

Human Rights

Perrigo is committed to the fight against modern slavery, child labor, unsafe working conditions and any other form of Human Rights abuse. We maintain a robust set of ethical standards that apply to all of Perrigo globally, as well as any contractors, suppliers, and other third parties doing business on our behalf. We conduct regular risk assessments and audits of our supply chain to ensure compliance with our internal standards and those of our customers.

Community Engagement

The Perrigo Company Charitable Foundation (the "Foundation") exists to support nonprofit organizations' initiatives in health and self-care, education, and community engagement and well-being within the communities where Perrigo operates around the world, mainly through a grant application process. The Foundation provides opportunities for our employees to get involved and give back their time and talent through charitable work and programs that put additional funds into the hands of those who need them most. We encourage all employees to volunteer in their local communities, which we believe has additional benefits on morale, mental health and goodwill as well as professional skills and network development.

More details on these and other Perrigo Company initiatives are available on our website at www.perrigo.com.

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GOVERNMENT REGULATION AND PRICING

The manufacturing, processing, formulation, packaging, labeling, testing, storing, distributing, advertising, and selling of our products are subject to regulation by a variety of agencies in the localities in which our products are sold. In addition, we manufacture and market certain of our products in accordance with standards set by various organizations. We believe that our policies, operations, and products comply in all material respects with existing regulations to which we are subject. Refer to Item 1A. Risk Factors - Operational Risks for related risks.

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. The FDA periodically inspects our facilities and reviews our quality management systems and manufacturing processes for compliance with applicable laws and regulations. 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.

Under the FDA's unified Human Foods Program, our infant formulas are subject to comprehensive regulation, including premarket review by the Office of Critical Foods, adherence to labeling and nutrient content requirements overseen by the Nutrition Center of Excellence and the Office of Nutrition & Food Labeling, compliance with Good Manufacturing Practice ("cGMP") and quality control procedures, and 90‑day premarket notification for formulations with fundamental changes in processing or composition. 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. Department of Health and Human Services ("HHS") launched Operation Stork Speed, an initiative focused on strengthening the safety, nutritional adequacy, transparency, and resilience of U.S. infant formula. This initiative intends to review the nutrients used in infant nutrition, expand testing for contaminants, enhance labelling expectations and will evaluate potential future regulatory updates. Although no new binding requirements have yet been finalized, resulting regulatory changes remain under evaluation and may affect future compliance and regulatory obligations for infant formula manufacturers. We actively monitor and adjust our processes to remain in compliance with all applicable laws and regulations.

Additionally, certain of our products are subject to regulation by the U.S. Department of Agriculture ("USDA"), the U.S. Environmental Protection Agency ("EPA"), and U.S. Drug Enforcement Administration ("DEA").

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. ("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. 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.

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. 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.

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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. 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. Notably, the following products are subject to the corresponding EU laws, standards, and regulations:

Medical Devices: To commercially distribute a medical device in the EU and affix the CE (Conformité Européenne) marking of conformity on such medical device, manufacturers must demonstrate conformity with the EU's Medical Device Regulation ("MDR") and applicable harmonized standards. 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.

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.

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. Such regulations also provide a 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, 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.

General Product Safety Directive: In addition to those EU directives for specific product groups, our products must comply with the General Product Safety Directive (2001/95/EC) governing safety and traceability (excluding pharmaceuticals, medical devices, and food), and failure to comply could result in fines and other penalties.

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. Customs and Border Patrol. Changes in laws, regulations, and practices affecting the pharmaceutical industry and the healthcare system, including imports, exports, manufacturing, quality, cost, pricing, reimbursement, approval, inspection, and delivery of healthcare, may affect our business and operations. International sanctions and boycotts of our products could also impact our sales and ability to export our products.

Tax Regulations

Recent Changes to Tax Laws, Regulations and Related Interpretations

The Organization for Economic Co-operation and Development (“OECD”), which represents a coalition of member countries, has recommended changes to numerous long-standing tax principles. In particular, the OECD's Pillar Two initiative introduces a global per-country minimum tax of 15%. 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.

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 the implementation of the Pillar Two framework to date.

On July 4, 2025, the One Big Beautiful Bill Act ("OBBBA") was signed into law. The OBBBA includes significant changes to federal tax law and permanently extends or modifies various provisions from the 2017 Tax Cuts and

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Perrigo Company plc - Item 1

Business

Jobs Act, including, but not limited to, deductions for federal bonus depreciation, domestic research and development expenditures, and certain changes, some taxpayer-favorable and others not, for determining the limitation on business interest expense. We evaluated the OBBBA provisions enacted and determined they resulted in a tax benefit of $21.7 million for 2025. The remaining provisions of the OBBBA have multiple effective dates, with certain provisions effective in 2025 and others implemented over subsequent years. 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. Our telephone number is +353 1 7094000. Our website address is www.perrigo.com. Our website and the information contained therein or linked thereto are not part of this Annual Report. 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"). These filings are also available to the public at www.sec.gov.

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Perrigo Company plc - Item 1A