Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 201

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 5
Chunk 201
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   an increase in the number of diagnosed patients and diagnosed but previously-untreated patients;
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●   geographic expansion; and
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●   physicians’ greater awareness of conditions and treatments.
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In 2024, 21.4% of our sales were generated in the European Union, as compared to 19.1% in 2023 and 17.0% in 2022. We anticipate that the percentage of our sales generated in the European Union will not significantly increase in 2025.
There are significant barriers to entry into the plasma derivative products industry, as the industry is highly regulated and requires significant expertise and capital investments. We do not expect these barriers to decrease in the near term.
Regulatory Environment. In order to operate in the plasma derivatives industry, manufacturers and distributors must comply with extensive regulation by the FDA, the EMA and comparable authorities worldwide. As a result, significant investments are required to develop, equip and maintain the necessary storage, fractionation and purification facilities and to develop appropriate sale, marketing and distribution infrastructures. Additionally, only proteins derived from plasma collected at FDA-approved centers can be marketed in the United States, so securing an adequate supply of U.S. source plasma is required to operate in the United States. We expect these regulatory restrictions to continue.
Product Pipeline. 
We have an expanded portfolio of key products as a result of our recent acquisitions and will continue to invest in research and development with respect to new product and new indications for existing products. Some key research and development projects underway include clinical studies of the use of albumin, diagnostic and vaccine therapies to treat Alzheimer’s disease, of albumin to treat advance cirrhosis and ascites, and of antithrombin in heart surgery.
Our product pipeline offers a strategic balance between risk and value across diverse phases. In 2024 we had 82 Biopharma initiatives in development and more than 80 Diagnostic projects in our pipeline. In 2023, our subsidiary Biotest AG achieved positive results in its phase 3 clinical trial for fibrinogen concentrate, marking a significant step in treating acquired fibrinogen deficiency. Other innovations reinforce our position in plasma-derived medicine, such as IG Yimmugo®, a newly developed immunoglobulin for the treatment of immunodeficiencies and autoimmune diseases, and Trimodulin, an antibody composition purified from human plasma in clinical development to treat severe community-acquired pneumonia (sCAP) and severe COVID-19.

E.   Critical Accounting Estimates
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The preparation of consolidated