BARCELONA - Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global leader in the production of plasma-derived medicines, announced today that its group company Biotest anticipates generating around USD 1 billion in revenue over the next seven years from its intravenous immunoglobulin (Ig) product, Yimmugo, in the United States. This follows the recent approval by the Food and Drug Administration (FDA) for the treatment of primary immunodeficiencies (PID).
Yimmugo is set to launch in the U.S. market in the first quarter of 2025. It will be distributed by Kedrion as part of a seven-year agreement and is a component of the Grifols Group’s broader strategy to expand its Ig therapeutic offerings in response to increasing patient demand.
The product is the first from Biotest's new FDA-certified production facility in Dreieich, Germany, to be commercialized in the U.S. The facility, known as Next Level, has already received approval for production and marketing in Europe, where Yimmugo has been available since late 2022.
Grifols is committed to growing its portfolio of intravenous and subcutaneous Ig treatments within the U.S., aiming to provide a comprehensive range of options for patients with immunodeficiencies. Yimmugo will be supplemented by other Grifols proteins, including fibrinogen and trimodulin, which are currently in late-stage development.
Roland Wandeler, President of Grifols Biopharma Business Unit, emphasized the company's mission to ensure the best care for patients and stated that their distribution strategy is designed to maximize the availability of their top-tier Ig products across the U.S.
Yimmugo is a sugar-free, ready-to-use solution approved in the U.S. for substitution therapy in primary antibody deficiency syndromes. It is part of a modern production process that Grifols highlights for its high product quality and responsible resource use.
The company warns that thrombosis, renal dysfunction, and acute renal failure are potential risks associated with immune globulin intravenous products, including Yimmugo, although it does not contain sucrose, which is commonly associated with these risks.
The information in this article is based on a press release statement from Grifols.
InvestingPro Insights
Grifols' recent announcement about the anticipated revenue from Yimmugo in the U.S. market reflects a strategic move to capitalize on its innovative plasma-derived medicines. The company's financial health and performance metrics underscore its capability to pursue such ambitious projects. According to recent data, Grifols has seen a revenue growth of 17.6% over the last twelve months as of Q4 2023, indicating a robust upward trajectory in its financial performance.
An InvestingPro Tip that stands out for Grifols is its impressive track record of maintaining dividend payments for 34 consecutive years, showcasing the company's commitment to delivering shareholder value consistently. This is further supported by the company's solid dividend yield of 3.78% as of mid-2023. Such a reliable dividend history may be particularly attractive to income-focused investors.
Additionally, Grifols has demonstrated profitability over the last twelve months, with a basic and diluted EPS (Earnings Per Share) from continuing operations at 1.16 USD. This financial stability is a positive sign for the company's ability to invest in and grow its product offerings, including the launch of Yimmugo in the U.S. market.
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