Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 23

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 3
Chunk 23
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 by the United States of the use of plasma collected from certain persons based on travel, residence or transfusion in the United Kingdom and concern over the safety of blood products, which led to increased domestic and foreign regulatory control over the collection and testing of plasma and the disqualification of certain segments of the population from the donor pool, significantly reducing the potential donor pool. This suspension was only lifted in 2022. The appearance of new viral strains could further reduce the potential donor pool. In past years, the COVID-19 pandemic also adversely impacted our plasma collection volumes because of, among other things, mobility restrictions.
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●   Changes in macroeconomic conditions could impact the number of donors. For example, in past years in the United States, the implementation of government stimulus programs issued to households during the COVID-19 pandemic had the two-pronged effect of both reducing the financial incentive for individuals to donate plasma and hindering our ability to maintain proper levels of workforce in plasma collection centers. Other macroeconomic factors such as a significant decrease in both inflation and interest rates in the United States in the future could result in increased access to cheaper debt to individuals, reducing the financial incentive for them to donate plasma;
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●   Changes in certain immigration policies and enforcement could impair some of our supply of plasma. See “—Restrictions on the ability of valid United States visa holders from Mexico to cross into the United States to donate plasma could disrupt our supply of plasma and adversely affect our financial performance.”
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●   Regulatory requirements. See “—Disruption of the operations of our plasma collection centers would cause us to become supply constrained and our financial performance would suffer.”
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●   Plasma supply sources. In recent years, there has been vertical integration in the industry as plasma derivatives manufacturers have been acquiring plasma collection centers. Any significant disruption in the supply of plasma or an increased demand for plasma may require us to obtain plasma from alternative sources, which may not be available on a timely basis.
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Disruption of the operations of our plasma collection centers would cause us to become supply-constrained and our financial performance would suffer.
In order for plasma to be used in the manufacturing of our products, the individual centers at which the plasma is collected must be licensed and approved by the regulatory authorities, such as the FDA and the EMA, of those countries in which we sell our