Biotest increases EBIT to Euro 19.8 million in the first half of 2023 – Biotech Investments

PRESS RELEASE

Biotest increases EBIT to Euro 19.8 million in the first half of 2023

 Turnover grows by 8.8 % to Euro 275 million

• Technology transfer and licensing agreement concluded with Grifols
• Two new plasma centres opened

Dreieich, 10 August 2023: In the first half of the 2023 financial year, the Biotest Group recorded revenues of € 275.3 million. This corresponds to an increase of 8.8 % compared to the revenues of € 253.1 million in the same period of the previous year.

The increase in revenues is due in particular to the new intravenous immunoglobulin Yimmugo^®, which was successfully launched on the market in November 2022 and is now the first commercial preparation to be manufactured in an innovative production process at the new Biotest Next Level production facility at the Dreieich site in Germany. In the first half of 2023, Biotest generated revenues of € 9.6 million with Yimmugo^®. In addition, revenue with Grifols, S.A. from the further development of Yimmugo^®, Fibrinogen and Trimodulin from January 2023 to June 2023 in the amount of € 14.9 million under the technology transfer and licensing agreement contributed to revenue growth. The agreement between Biotest AG and Grifols S.A. was signed on 31 May 2023 with effect from 1 January 2023.

Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to € 37.5 million in the first half of the 2023 financial year, compared to € 8.8 million in the first half of the previous year. This corresponds to an increase of 326 %.

Compared to the same period of the previous year, EBIT at Group level increased to € 19.8 million in the first six months of the 2023 financial year (same period of the previous year: € -9.1 million). The main reason for this development was the gain of € 23.1 million from the sale of five Biotest subsidiaries to Grifols.

Adjusted for exceptional items from revenues with Grifols from development services as well as the gain on disposal of five Biotest subsidiaries, the adjusted EBIT for the first half of 2023 amounted to € -5.2 million. In the previous year, the exceptional item exclusively related to expenses from the Biotest Next Level expansion project, with which the adjusted EBIT was at € 32.4 million in the same period of the previous year. 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

For the Biotest Group, earnings before taxes (EBT) amount to € 1.2 million after € – 18.0 million in the same period of the previous year.

The Biotest Group’s total earnings after tax (EAT) increased to € 1.7 million in the first half of 2023 (same period of the previous year: € – 19.9 million) in view of the influencing factors described. This results in earnings per ordinary share of € 0.03 after € – 0.50 in the first half of 2022.

Within its research and development activities, Biotest is continuing to intensify its efforts to rapidly develop the product 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. Thus, 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.

With Trimodulin, a further phase III trial in the indication of severe community-acquired pneumonia has been initiated. The majority of study approvals by the authorities in the various countries have been obtained and the first study centres have been opened.

In addition, Biotest reached another important milestone at the end of June 2023 with the submission of the Biologics License Application (BLA) for the polyspecific immunoglobulin preparation Yimmugo (IgG Next Generation) to the US Food and Drug Administration (FDA). It is the first product manufactured by Biotest in Dreieich for which an application for approval has been submitted to the FDA.

In the reporting period, Biotest AG opened two new plasma collection centres. In addition, further new plasma centres are planned in 2023 in order to place the supply of plasma on a broader basis.

Guidance:

Biotest AG, Dreieich, Germany and Grifols, S.A., Barcelona, Spain have signed various agreements, including the Technology Transfer and Licensing Agreement. These agreements ensure that Biotest’s new product developments can be manufactured and marketed worldwide by using Grifols’ organisation and production network. In return, payments for technology as well as recurring licence payments to be made at a later date based on the revenues of the licensed products were agreed. The revenues from the technology transfer and the development services are expected to have a positive effect on earnings before interest and taxes (EBIT) in the triple-digit millions in the second half of 2023.

Therefore, in April 2023, the Executive Management Board raised the EBIT forecast for the year 2023 from € – 20 to € – 15 million to a level that may exceed € 100 million. A more precise determination depends on the revenue and earnings recognition of the final project milestones.

For the financial year 2023, the Management Board aims to increase sales by a mid-single-digit percentage compared to 2022, excluding sales from under the technology and licensing agreement. This increase in sales is possible due to the commissioning of the Yimmugo^® production facility within Biotest Next Level. The Board of Management does not rule out further negative sales developments as a result of possible cyclical declines in demand and country-specific savings in the healthcare sector.

The report on the first half 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 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.