Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 86

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 4
Chunk 86
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 Republic, Slovakia, Iceland, Finland, and the United Kingdom in 2024).
Human Rabies Immunoglobulin (“HRIG”)
We believe HyperRAB® is the world’s leading HRIG indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies who have not been previously vaccinated with rabies vaccine. HyperRAB®, a 300 IU/ml formulation of which is available in the United States, is the only HRIG provided as a higher-potency formulation, potentially requiring fewer injections in administration of each dose. We had an estimated 87% market share in sales of anti-rabies immunoglobulins in the United States as of December 2024.
Alpha-1-Antitrypsin Augmentation Therapy (AAT)
We believe that we are the global market leader in the sales of AAT products. On December 31, 2024, our AAT products had 58 licenses in 27 countries worldwide, 19 of which are located in North America and Europe. Based on our estimations we had more than a 70% global sales market share for AAT as of December 2024. Our main brand for AAT products is Prolastin®, a chronic augmentation and maintenance therapy to treat emphysema related to severe hereditary A1PI deficiency. We sell the freeze-dried powder formulation of Prolastin® primarily in North and South America and Europe. In 2024, we launched new 4- and 5-gram vial sizes for this formulation of Prolastin® in a number of countries in Europe, including Germany, Denmark, France, Austria, Spain, Portugal and Italy. In addition, our ready-to-use liquid formulation of AAT (Prolastin®-C Liquid) is FDA-approved and sold in the United States and we are currently conducting a worldwide clinical trial to meet post-approval regulatory commitments and obtain regulatory approval for Prolastin®-C Liquid in Europe. In 2023, we sponsored over 150,000 genetic tests in connection with this ongoing clinical trial.
Hemophilia A 
Between Koate®-DVI, Fanhdi and Alphanate, all products to control bleeding in hemophilia A patients, we had an estimated 14.3% market share based on volume globally in the pdFVIII hemophilia A market in 2023 (excluding Von Willebrand disease use).
Albumin
We