Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 3

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 3
Chunk 3
---
---

●   Changes in immigration laws in the countries in which we operate, including Canada and the United States, could affect our ability to send employees with specified expertise in manufacturing and IT into foreign regions for purposes of building or upgrading certain infrastructure.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Risks Relating to the Company and Our Business:

●   Our manufacturing processes are complex and involve biological intermediates that may be susceptible to contamination and variations in yield. Plasma and plasma derivative products are fragile, and improper handling of the plasma or plasma derivative products could adversely affect our operations;
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

●   Once our products are approved and marketed, we must continually monitor them for signs that their use may result in serious and unexpected side effects, which could jeopardize our reputation and our ability to continue marketing our products. We may also be required to conduct post-approval clinical trials as a condition to licensing a product. Moreover, we may not be able to commercialize products in development;
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

●   Our ability to continue manufacturing and distributing our products depends on our continued adherence to cGMP regulations at our facilities;
-------------------------------------------------------------------------------------------------------------------------------------------------

●   A significant disruption in our supply of plasma, including as a result of macroeconomic conditions, pandemics or changes in immigration policies and enforcement could have a material adverse effect on our business and our growth plans;
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

●   Disruption of the operations of our plasma collection centers would cause us to become supply-constrained and our financial performance would suffer;
---------------------------------------------------------------------------------------------------------------------------------------------------------
2

●   A significant portion of our net revenue has historically been derived from sales of our immunoglobulin (“IG”) products and we expect that they will continue to comprise a significant portion of our sales. Any adverse market event with respect to these products could have a material adverse effect on us;
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

●   We face significant competition;
------------------------------------

●   We face competition from companies with greater financial resources;
------------------------------------------------------------------------

●   Technological changes in the production of our products may require substantial investments in innovation, digital transformation and new technologies, which could render our production process uneconomical and diminish our competitiveness in the industries in which we operate;
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

●   The discovery of new pathogens could slow our growth and adversely affect profit margins;
---------------------------------------------------------------------------------------------

●   Product liability claims or product recalls and/or voluntary withdrawals involving products we produce or distribute could have a material adverse effect on our business;
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

●   Our ability to continue to produce safe and effective plasma