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

EQS-News: Biotest AG / Key word(s): Market Launch
Biotest prepares launch of its immunoglobulin Yimmugo in the USA,
establishing a framework for a strategic billion-dollar distribution
agreement with Kedrion

01.07.2024 / 09:00 CET/CEST
The issuer is solely responsible for the content of this announcement.

---------------------------------------------------------------------------

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).

Biotest AG will now also be publishing official press releases via X. You
can find us at: https://twitter.com/BiotestAG

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.


---------------------------------------------------------------------------

01.07.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS
News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com

---------------------------------------------------------------------------

   Language:       English
   Company:        Biotest AG
                   Landsteinerstraße 5
                   63303 Dreieich
                   Germany
   Phone:          0 61 03 - 8 01-0
   Fax:            0 61 03 - 8 01-150
   E-mail:         ir@biotest.com
   Internet:       www.biotest.de
   ISIN:           DE0005227235, DE0005227201
   WKN:            522723, 522720
   Listed:         Regulated Market in Frankfurt (Prime Standard);
                   Regulated Unofficial Market in Berlin, Dusseldorf,
                   Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
   EQS News ID:    1936245

End of News EQS News Service
---------------------------------------------------------------------------

1936245 01.07.2024 CET/CEST