PRESS RELEASE

Biotest increases EBIT to Euro 125.4 million in the first nine months of 2023

• Turnover grows by 38.7 % to Euro 500 million
• Technology transfer and licensing agreement concluded with Grifols
• Two new plasma centres opened

Dreieich, 2 November 2023: In the first nine months of the 2023 financial year, the Biotest Group recorded revenues of € 500.3 million. This corresponds to an increase of 38.7 % compared to the revenues of € 360.8 million in the same period of the previous year.

This revenue growth is mainly due to revenue generated from technology disclosure and development services with Grifols, S.A., Barcelona, Spain, amounting to € 135.4 million as part of the technology transfer and licensing agreement. This agreement was signed on 31 May 2023 with effect from 1 January 2023. In 2023, three of a total of six technology components were disclosed by Biotest within the technology and license agreement to Grifols.

The revenue growth is also due to the new intravenous immunoglobulin Yimmugo^®, which 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. In the first nine months of 2023, Biotest generated revenues of € 16.1 million with Yimmugo^®. Biotest received marketing authorization for Yimmugo® in the UK at the end of August 2023.

Compared to the prior-year period, consolidated EBIT grew to € 125.4 million in the first nine months of the 2023 financial year (prior-year period: € - 19.0 million). This growth mainly reflects the earnings effect from the technology transfer and licensing agreement amounting to € 112.3 million as well as the gain on the divestiture of five Biotest sales companies to Grifols, S.A., amounting to € 23.1 million.

Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to € 152.2 million in the first nine months of the 2023 financial year, compared to € 7.8 million in the first nine months of the previous year.

Adjusted for exceptional items from revenues with Grifols from technology disclosure and development services as well as the gain on disposal of five Biotest sales companies, the adjusted EBIT for the first nine months of 2023 amounted to € - 10.0 million. Since the new production facility was successfully commissioned with the market launch of Yimmugo^® as part of the Biotest Next Level expansion project, expenses for this are no longer reported separately as in previous years.

Adjusted EBIT

The financial result decreased to € - 29.3 million in the first nine months of the current financial year (prior-year period: € - 11.9 million). This decrease is mainly due to the € 10.7 million increase in interest expenses. Tax expenses increased by € 4.4 million to € 7.6 million compared to the previous year. This development is due to the higher income taxes in connection with the earnings effect from technology disclosure and development services.

Given the aforementioned influencing factors, the Biotest Group’s earnings after taxes increased to € 88.4 million in the first three quarters of the 2023 financial year compared with € - 34.2 million in the same period of the previous year. This is equivalent to earnings per ordinary share of € 2.22 compared with € - 0.87 in the same period of the previous year.

Within its research and development activities, Biotest is continuing to intensify its efforts to rapidly develop the development candidates Fibrinogen and Trimodulin, which are in late clinical phase III and are to be produced in the new Biotest Next Level facility, and to bring them to approval. Biotest develops Fibrinogen not only for congenital but also for acquired fibrinogen deficiency. In March 2023, an interim analysis of the Phase III AdFIrst study in acquired fibrinogen deficiency confirmed the number of patients originally planned for the study. At the end of September 2023, the last required patient was enrolled and treated in the study.

Moreover, a second Phase III trial with Trimodulin in the severe community-acquired pneumonia indication (sCAP) was launched. In Sep-tember 2023, the first patient with sCAP was treated in an intensive care unit as part of the Phase III ESsCAPE study. This multinational Phase III clinical trial will enrol approximately 590 adult patients with sCAP. The ESsCAPE trial is being conducted in up to 20 countries worldwide.

In September 2023, Biotest also 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 accepted the Biologics License Application (BLA) for the polyspecific immunoglobulin preparation Yimmugo (IgG Next Generation) for review. The marketing authorisation application covers the primary immuno-deficiencies (PID) indication. After receiving marketing authorisation, Biotest plans to expand the indication to include chronic primary immune thrombocytopenia (ITP).

In the reporting period, Biotest AG opened two new plasma collection centres. In addition, further new plasma centres are planned in 2024 in order to place the supply of plasma on a broader basis.
 

Guidance:

Given the agreements concluded between Biotest AG, Dreieich, Germany and Grifols, S.A., Barcelona, Spain, which include a technology transfer and licensing agreement, in April 2023 the Board of Management of Biotest AG had indicated that EBIT could potentially exceed € 100 million. The Board of Management announced on 5 October 2023 that, based on current knowledge, it expects EBIT for the 2023 financial year to lie in a range between € 130 million and € 170 million. A more precise determination depends on the realization of revenue and earnings from the final project milestones.

For the 2023 financial year, the Board of Management is continuing to aim for mid-single-digit percentage revenue growth compared to 2022, excluding revenue from the technology transfer and licensing agreement. This revenue growth is enabled by the commissioning of the Yimmugo^® production facility within Biotest Next Level. The Board of Management does not rule out negative influences on revenue due to potential reductions in demand owing to the economic situation and country-specific savings in the healthcare sector.

The nine month of 2023 can be found on the company's website under the following link Quarterly Reports (biotest.com).

About Biotest

Biotest is a provider of plasma proteins and biotherapeutic drugs. With a value chain that extends from preclinical and clinical development to worldwide marketing, Biotest specialises primarily in the application areas of clinical immunology, haematology and intensive and emergency medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin, which are produced on the basis of human blood plasma and are used for diseases of the immune system or the blood-forming systems. Biotest employs more than 2,300 people worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard of the German Stock Exchange. Since May 2022, Biotest has been part of the Grifols Group, Barcelona, Spain (www.grifols.com).

IR Contact:

Dr. Monika Baumann (Buttkereit)
Phone: +49-6103-801-4406
E-mail: ir@biotest.com

PR Contact:

Dirk Neumüller
Phone: +49 -6103-801-269
E-mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.com

Ordinary share: WKN: 522720; ISIN: DE0005227201
Preference share: WKN: 522723; ISIN: DE0005227235
Listed: Frankfurt (Prime Standard)
OTC: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements regarding the overall economic development as well as the business, earnings, financial and asset situation of Biotest AG and its subsidiaries. These statements are based on the company's current plans, estimates, forecasts and expectations and are therefore subject to risks and uncertainties that could cause actual developments to differ materially from those anticipated. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and does not assume any obligation to do so.