2023 IRISH STATUTORY ACCOUNTS

The decision to discontinue StrataGraft was made following a slower-than-anticipated commercial uptake of the product and slower-than-anticipated enrollment in clinical trials. We are evaluating our next steps with respect to StrataGraft, which could include pursuing a sale, out-license or other strategic arrangement. [...] market, and to a lesser extent the impact of competitive oral therapies for GvHD. [...] We may face new opioid claims in the future, which could have a material adverse effect on our competitive position, business, financial condition and results of operations. In connection with the 2020 Bankruptcy Proceedings, we implemented steps to comply with an Operating Injunction enjoining certain Mallinckrodt entities from engaging in certain conduct related to the manner in which they op [...] If additional state or local jurisdictions successfully enact such legislation and we are not able to mitigate the impact on our business through price increases, operational changes or commercial arrangements, such legislation in the aggregate may have a material adverse effect on our business, financial condition, results of operations and cash flows. See the risk factor captioned "Extensive [...] Accordingly, our turnover and results of operations may be negatively affected by the loss of a contract with a GPO or IDN. [...] In addition, although we have contracts with many major GPOs and IDNs, the members of such groups may choose to purchase from our competitors, which could result in a decline in our turnover. [...] Any of these actions could cause a loss of customer confidence in our products, which could adversely affect our turnover, or otherwise have a material adverse effect on our competitive position, business, financial condition, results of operations and cash flows. In addition, the requirements of regulatory authorities, including interpretative guidance, are subject to change and compliance wit [...] The loss of key scientific, technical, regulatory and commercial personnel, or the failure to recruit additional key scientific, technical, regulatory and commercial personnel, could have a material adverse effect on our competitive position, business, financial condition, results of operations and cash flows. There is intense competition for qualified personnel in our industry, and we may not [...] If an impairment were recognized, this could have a material impact to our financial condition and results of operations. We are subject to labor and employment laws and regulations, which could increase our costs and restrict our operations in the future. [...] In addition, volatility in the world financial markets could increase borrowing costs or affect our ability to access the capital markets, which could have a material adverse effect on our competitive position, business, financial condition, results of operations and cash flows. Borrowing capacity under our receivables-based financing facility may decrease, may not be extended upon maturity, or