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• Adjusted EBIT increased to € 41.1 million
• Two development projects regarding a therapy for COVID-19 infection started
• Biotest Next Level expansion project running according to plan

In the first half of financial year 2020, the Biotest Group recorded revenue of € 234.8 million (same period of the previous year: € 195.1 million). On a half-year basis, sales were € 39.7 million or 20.3 % above the figure for the same period last year. The revenue growth is mainly due to increased revenue in the Therapy segment and in the Plasma & Services segment. The 17.8 % (€ 31.3 million) growth in revenue in the Therapy segment is the result of both increased sales volumes and higher selling prices for important products such as Intratect^® and human albumin. The revenue growth in the Plasma & Services segment of 62.7 % (€ 9.6 million) was due to significantly higher contract manufacturing.

EBIT amounted to € 0.7 million in the first six months of financial year 2020 (same period of the previous year: € –5.5 million). This includes expenses of € 40.3 million for the expansion project Biotest Next Level (same period of the previous year: € 34.5 million). The significantly stronger EBIT compared to the previous year in the Therapy segment is primarily the result of increased revenue. In particular, revenue in Biotest’s new Chinese market made a positive contribution to EBIT development.

In the first half of 2020, the adjusted EBIT of the existing product business without the expenses for the expansion project Biotest Next Level (€ 40.3 million) and for monoclonal antibodies (€ 0.1 million) was € 41.1 million, compared to € 29.9 million in the previous year. The adjusted EBIT margin for the first six months of the current financial year was 17.5 %, compared to 15.3 % for the same period of the previous year.

Two new development projects for the therapy of COVID-19 infections were started. On the one hand, Biotest has an innovative antibody product, Trimodulin, which is unique worldwide and which has already produced promising results in a Phase II study with 160 mechanically ventilated patients with severe Community Acquired Pneumonia (sCAP) in patients who had high inflammation levels (CIGMA study). In the multinational Phase II ESsCOVID study, seriously ill COVID-19 patients are now also to be treated with Trimodulin. Biotest is pursuing the goal of making Trimodulin available as a treatment option for COVID-19 patients as quickly as possible by means of an accelerated approval procedure.

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 Bio Products Laboratory, CSL, LFB, Octapharma and Takeda.

In order to expand the product range and increase capacity, Biotest started the expansion project Biotest Next Level. In financial year 2020, further progress was made with this project. The validation of the clean rooms and media systems and their approval by the Darmstadt Regional Council in November 2019 was followed by the second approval by the Darmstadt Regional Council in mid-June 2020. Here, the validation of the process equipment and the in-process control laboratories was approved.

Despite a few bottlenecks in terms of personnel and materials due to the corona crisis, commissioning is progressing and in two further acceptance inspections by the Regional Council in the fourth quarter of 2020 and the first quarter of 2021, the manufacturing license in accordance with §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 and Cash Flow will be at the lower end of the ranges given.

The half-year report is available on the company’s website https://www.biotest.com/de/en/investor_relations/news_and_publications/publications/quarterly_reports.cfm