Company: PRGO
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0001585364-25-000014
Chunk: 355

Company: PERRIGO Co plc
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1A
Chunk 355
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 and/or financial condition. 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. 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. 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 1ARisk 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. 

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. 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. 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. 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. In light of