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Biotest AG, DE0005227235

Biotest AG, DE0005227235

12.11.2020 - 07:04:31

Biotest AG: Biotest increases adjusted 9-month EBIT by over 21% to - 52 million

Both development projects for the therapy of COVID-19 infections made good progress: Due to the great similarity of the clinical picture to the patients treated in the CIGMA study, Biotest sees Trimodulin as having considerable potential for patients with severe pneumonia after a COVID-19 infection. A phase II study (ESsCOVID - Escape from severe COVID-19) with COVID-19 patients was approved in order to accelerate the development of Trimodulin in view of the current COVID-19 pandemic. Plans for accelerated development have been discussed with the regulatory authorities in Europe and the USA. The study design was submitted to the competent authority and the Ethics Committee in Spain, Brazil, Russia and France. The study design has already been approved in Spain, Russia and Brazil. In parallel, Biotest is expanding its planned phase III study in sCAP to include COVID-19 patients.

Biotest is also working on a new drug against COVID-19 based on plasma donations from donors previously recovered from COVID-19. The donations contain antibodies that can neutralize the coronavirus. This drug contains these antibodies in a purified form and could then be used therapeutically against COVID-19. In order to advance the development as quickly as possible, Biotest has entered into an industry-wide cooperation within the COVID-19 Plasma Alliance with companies such as CSL, LFB, Octapharma and Takeda. This alliance is developing this polyclonal hyperimmunoglobulin treatment for SARS-CoV-2.

In order to expand the product range and double production capacity, Biotest started the expansion project Biotest Next Level. In financial year 2020, further progress was made with this project. In June the second approval took place and in October 2020, another partial inspection for the commissioning of the BNL plant took place by the Darmstadt Regional Council. The main focus of the inspection was the new SAP-based software for the collection and management of the raw material plasma and plasma based intermediate products.

Despite some difficulties caused by the Corona pandemic, the commissioning of the BNL production plant is progressing. In the second quarter of 2021, the manufacturing license in according to ?13 of the German Medicines Act (AMG) is to be obtained.

Outlook: The Board of Management expects sales growth of around 10 % for financial year 2020. Earnings in 2020 will be influenced by various factors. Besides the expected expenses of ? 80 million to ? 90 million from the Biotest Next Level expansion project, including the associated research and development costs, the tense situation in the crisis regions, particularly in the Middle East and Asia, could also have an impact. Based on the aforementioned factors, the Board of Management expects EBIT to be between ? -10 million and ? -5 million. In particular as consequence of the increased expenditures on the two new COVID-19 studies the Management Board expects that earnings will be at the lower end of the range given.

The nine month report is available on the company's website https://www.biotest.com/de/en/investor_relations/news_and_publications/publications/quarterly_reports.cfm

About Biotest Biotest is a provider of plasma proteins and biological drugs. 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 1,900 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

IR contact Dr Monika Buttkereit Phone: +49-6103-801-4406 Mail: investor_relations@biotest.dePR contact Dirk Neum?ller 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, D?sseldorf, 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.

12.11.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de

Language: English Company: Biotest AG Landsteinerstra?e 5 63303 Dreieich

Germany Phone: 0 61 03 - 8 01-0 Fax: 0 61 03 - 8 01-150 E-mail: investor_relations@biotest.de Internet: http://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: 1147438 ? End of News DGAP News Service


@ dgap.de