EQS-News

Biotest AG increased sales by 32% in the financial year 2023 - Seite 2

 

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.