Strategic agreement signed for distribution of Yimmugo® in the United States based on the framework established in July – Biotech Investments

PRESS RELEASE

Strategic agreement signed for distribution of Yimmugo^® in the United States based on the framework established in July

• All contractual terms finalized and definitive agreement with Kedrion signed
• Expected to generate revenues of more than $1 billion for Biotest during the 7-year term
• Preparations for U.S. launch of Yimmugo^® in 2025 well underway

Dreieich, Germany, October 2, 2024. Following the agreement of binding terms in July, the parties have now finalized all contractual terms and Biotest, part of the Grifols Group, has entered into a long-term agreement with Kedrion Biopharma Inc., Fort Lee (NJ), USA, for the full commercialization and distribution of its immunoglobulin Yimmugo^® in the United States.

The distribution agreement requires Biotest to supply and Kedrion to purchase minimum quantities of Yimmugo^® over the seven-year term, representing approximately $1 billion in sales for Biotest. This agreement represents Biotest’s largest commercial agreement since its founding.

Production of the quantities needed to enter the United States began immediately after the Biologic License Application (BLA) was approved and is ongoing. Preparations for the market launch of the product in 2025 have already begun and are now in full preparation.

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 most important market for the plasma derivatives sector.

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 U.S. 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).

IR contact

Dr Monika Baumann (Buttkereit)

Phone: +49-6103-801-4406
Mail: ir@biotest.com

PR contact

Dirk Neumüller

Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201

Preference shares: securities’ ID No. 522723; ISIN DE0005227235

Listing: Frankfurt (Prime Standard)

Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.