Biotest AG
Biotest AG increased sales by 32% in the financial year 2023

PRESS RELEASE

Biotest AG increased sales by 32% in the financial year 2023

• EBIT forecast achieved with EBIT of € 143 million
• Yimmugo marketing authorization application submitted to the US FDA
• Phase III study with fibrinogen successful

Dreieich, 28 March 2024. In the financial year 2023, the Biotest Group generated revenue of € 684.6 million compared with € 516.1 million in the previous year. This corresponds to significant revenue growth of 32.7%. This revenue growth is mainly due to revenue generated from technology disclosure and development services for Grifols, S.A., amounting to € 190.1 million as part of the technology transfer and licensing agreement. Excluding revenue generated from technology disclosure and development services for Grifols, S.A., revenue of € 494.5 million was achieved. This corresponds to a decrease of 4.2 % compared to the previous year.

The new intravenous immunoglobulin Yimmugo^® had a positive impact with revenue amounting to € 27.2 million. Yimmugo^® was successfully launched in November 2022 and is now the first commercial preparation to be produced in an innovative manufacturing process in the new Biotest Next Level production facility at the Dreieich site in Germany.

The consolidated EBIT result in the 2023 financial year of € 143.5 million improved considerably compared with € -16.6 million in the previous year. Biotest has thereby clearly exceeded its original EBIT guidance for the 2023 financial year of between € -20 million and € -15 million, and achieved its most recent EBIT guidance of between € 130 million and € 170 million. This growth mainly reflects the earnings effect from technology disclosure and development services for Grifols, S.A., amounting to € 158.2 million, as well as the gain on the divestiture of five Biotest sales companies to Grifols, S.A., amounting to € 23.1 million.
 

For the Biotest Group, overall earnings before taxes (EBT) of € 106.3 million arose, compared to € -30.8 million in the previous year.

The Biotest Group’s earnings (EAT) for the 2023 financial year amounted to
€ 127.0 million compared to € -31.7 million the previous year. This results in earnings per ordinary share of € 3.20 compared with € -0.81 in the previous year.

The past 2023 financial year paved the way for intensifying the partnership with the majority shareholder Grifols, S.A. The aim is to work more closely together in the areas of research and development, production, as well as sales and distribution while maintaining both companies’ respective independence, and thereby to be able to offer their complementary product portfolios in significantly more countries, exchange knowledge, and provide patients with enhanced access to life-saving plasma medicines. The most important contracts were the technology disclosure and development services with Grifols, S.A.

Since November 2022, the intravenous immunoglobulin Yimmugo® has been the first commercial preparation to be produced by way of an innovative manufacturing process in the new Biotest Next Level production facility at the Dreieich site in Germany. In September 2023, Biotest reached an important milestone in the marketing authorisation process for Yimmugo® in the USA. The US Food and Drug Administration (FDA) informed Biotest that it accepts the Biologics License Application (BLA) for Yimmugo® for review. The marketing authorisation application covers the primary immunodeficiency (PID) indication.

In December 2023, the FDA conducted the Pre-License Inspection (PLI) of the Biotest Next Level facility. Among other areas, the quality systems, the new facility for the production of Yimmugo® in the Biotest Next Level building and the general conformity of the production processes with the submitted dossier were inspected and reviewed. A document with the findings from this inspection was compiled as part of the authorisation process. Further steps towards a Biologics License Application (BLA) will be carried out in the course of 2024.

Biotest is developing Fibrinogen for use in both congenital and acquired fibrinogen deficiency. In mid-February 2024 Biotest announced, that the Fibrinogen “AdFIrst study” has reached its primary endpoint.

Outlook:

For the 2024 financial year, the Board of Management is aiming for upper single-digit percentage revenue growth compared to 2023, including revenue from technology disclosure and development services for Grifols, S.A.

Accordingly, the Board of Management expects an operating result (EBIT) in a range between € 80 million and € 100 million for 2024.

The 2023 Annual Report and the 2023 Sustainability Report are available on the company’s website. The presentation for the hybrid conference for analysts and journalists is also available for download.

About Biotest

Biotest is a supplier of biological medicinal products derived from human plasma. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic 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 is part of the Grifols Group, 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.