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

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 3
Chunk 25
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 historically derived a significant portion of our net revenue from our immunoglobulin products, including our immunoglobulin products. In 2024 and 2023, our intravenous immunoglobulin (“IVIG”) products accounted for approximately 50.8% and 48.5% of our net revenue, respectively. If any of these IVIG products were to lose significant sales or were substantially or completely displaced in the market, we would lose a significant and material source of our net revenue. Similarly, if either Flebogamma®, Gamunex®-C/Gamunex®, Xembify® or Prolastin® were to become the subject of litigation or an adverse governmental ruling requiring us to cease sales of it, our business could be adversely affected. Although we do not currently anticipate any significant decrease in the sales of any of these products, a significant decrease could result from plasma procurement and manufacturing issues resulting in lower product availability for sales and changing market conditions.

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We face significant competition.
We face significant competition. Each of Takeda, CSL Behring, Kedrion Biopharma, Octapharma Plasma and Bio Products Laboratory Ltd. now has a 10% liquid IVIG product in the United States. Both Octapharma and Bio Products Laboratory also have 5% liquid IVIG products. GC Biopharma introduced its 10% IVIG product, AlygloTM, to the U.S. market in 2024 and Argenx obtained FDA approval in 2024 for VYVGART Hytrulo (subcutaneous), an IVIG product that would treat patients with chronic inflammatory demyelinating polyneuropathy (“CIDP”). Such products are direct competitors to some of our main products, Flebogamma®, Gamunex®-C/Gamunex® or Xembify®. As competition has increased, some of our competitors have discounted the price of immunoglobulin products as many customers have become increasingly price sensitive. If customers demand lower priced products, we may lose sales or be forced to lower our prices.
In the therapeutic area of pulmonology, specifically alpha-1-antitrypsin augmentation therapy (“AAT”), we face competition from other companies such as Vertex, Kamada, Mereo Biopharma, AATec Medical and Korro Bio researching and developing novel inhaled and recombinant AAT therapies and the potential of gene therapies focusing on alpha-1. In addition, we expect increased competition will come