Biotest prepares launch of its immunoglobulin Yimmugo in the USA, establishing a framework for a strategic billion-dollar distribution agreement with Kedrion

PRESS RELEASE

Biotest prepares launch of its immunoglobulin Yimmugo in the USA, establishing a framework for a strategic billion-dollar distribution agreement with Kedrion

• Production of U.S. launch quantities of Yimmugo^® has commenced following BLA approval
• Biotest will start deliveries to the U.S. in Q4 2024 for the planned launch in Q1 2025
• Strategic distribution agreement with Kedrion is expected to generate revenues of more than $1 billion for Biotest during the 7-year term
• Yimmugo^® is the first of several Biotest proteins in late-stage development, including fibrinogen and trimodulin, and its FDA approval underpins Biotest's future growth strategy in the U.S.

Dreieich, Germany, July 1, 2024. Biotest AG announced today that it has established the framework for a long-term agreement with Kedrion for the full commercialization and distribution of its immunoglobulin Yimmugo^® in the United States following its Biologic License Application (BLA) approval by the U.S. Food and Drug Administration (FDA) on June 13, 2024.

The framework in the form of a term sheet calls for Kedrion to purchase minimum quantities of Yimmugo^® during the seven-year term beginning when the definitive agreement is finalized, representing approximately $1 billion in sales for Biotest.

"With Yimmugo^®, we are very excited to enter this important market for our industry and are committed to developing and delivering more therapies to patients in the U.S. in the coming years. We have taken the first step towards this agreement with Kedrion for in-market commercialization, which represents our largest commercial agreement since the formation of Biotest," said Peter Janssen, CEO of Biotest AG. "Based on Kedrion's proven experience and extensive coverage in this important immunoglobulin market, I am confident that Yimmugo^® will be a commercial success in the U.S. and provide an additional meaningful treatment option to patients."

Biotest is expected to start supplying Yimmugo^® to Kedrion in the fourth quarter of 2024. Yimmugo^® is the first drug approved in the U.S. to be manufactured using an innovative process in Biotest's new "Next Level" manufacturing facility. It has been evaluated for safety, efficacy and tolerability in extensive pivotal studies. Market launch is planned for the first quarter of 2025. Yimmugo^® will complement other leading Grifols Group immunoglobulin therapeutics.

The "Biotest Next Level" (BNL) investment program has more than doubled the Biotest Group’s production capacity. Our new production facility will also bring about a quantum leap in our sustainability performance. Numerous process innovations, targeted investments in special insulation and the use of natural refrigerants such as carbon dioxide will not only enable us to significantly reduce resource and energy consumption in production per liter of final product, but also to undercut the requirements of the German Building Energy Act [Gebäudeenergiegesetz, GEG].

“This collaboration demonstrates Kedrion’s capability and commitment to advancing immunoglobulin supply for U.S. patients and our strategy to address primary humoral immunodeficiency for as many patients as possible,” said Ugo Di Francesco, CEO of Kedrion Biopharma. “We are proud of the role we are playing in helping patients across the US address their unmet needs, and we look forward to maximizing the success of this product.”

“Congratulations to Biotest on this milestone that significantly benefits the Grifols Group and ensures continued access across all products of our immunoglobulin franchise, including our best-in-class GAMUNEX^®-C and XEMBIFY^® brands,” said Roland Wandeler, President Grifols Biopharma Business Unit. “As part of the Group’s broader distribution strategy, we are pleased that Kedrion will be commercializing Yimmugo^® while the Grifols team continues to focus on the growth of its existing portfolio of immunoglobulin treatments.”

Biotest and the Grifols Group have collaborated with Kedrion in the U.S. market for several years. This agreement when finalized will be the largest commercial agreement signed by Biotest in its 78-year history. The financial terms reflect a rapid market introduction thanks to Kedrion's commercial and distribution expertise in the U.S. market and the growing demand for immunoglobulin therapies such as Yimmugo^®.

With Yimmugo^®, a Biotest product is entering a U.S. market which, with more than 100 tons and annual IVIG sales of $10 billion, represents the main market for the plasma derivatives sector.

To support its growth strategy in this market, Biotest has two other plasma proteins on the horizon for markets including the U.S., both in late-stage development, the first being a fibrinogen concentrate (FC) for the treatment of acquired fibrinogen deficiency - it would be the first FC approved for this indication in the U.S. - and trimodulin, a polyvalent antibody composition for the treatment of community-acquired pneumonia (CAP) or severe community-acquired pneumonia (sCAP).

About Yimmugo^® (IgG Next Generation)

Yimmugo^® is a newly developed polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIg). The sugar-free ready-to-use solution is approved in European markets for substitution therapy in primary antibody deficiency syndromes and secondary immune deficiency, as well as for immunomodulation in autoimmune diseases such as ITP, GBS, CIDP, MMN and Kawasaki syndrome. Under the US license Biotest is authorized to manufacture Yimmugo^® for the treatment of primary humoral deficiency (PI) in patients 2 years of age or older. Yimmugo^® is the first approved product from Biotest’s new Next Level production facility. The modern production process stands for highest product quality and responsible use of resources.

About Biotest

Biotest (www.biotest.com) is a provider of biological therapeutics derived from human plasma. With a value-added chain that extends from preclinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German Stock Exchange. Since May 2022, Biotest has been a part of the Grifols Group, headquartered in Barcelona, Spain (www.grifols.com).

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