Biotest generates revenues of EUR 377.8 million in the first nine months 2017
- Successful regulatory inspection and approval of Biotest Next Level in August
- Paul-Ehrlich Institute approves Phase III trial in the indication of acquired fibrinogen deficiency
Dreieich, 14 November 2017. In the first nine months of the 2017 financial year, the Biotest Group generated revenue of EUR 377.8 million, after EUR 413.8 million in the same period of the previous year. This corresponds to a decrease of 8.7 %. The sales development was significantly impacted by the recall of human albumin and the temporary interruption of human albumin production, which Biotest has already reported on in the Half-Year Report and in the statement on the first quarter of 2017. EUR 21.0 million of this sales decrease can be attributed to sales reductions as a result of the recall of various batches of the human albumin product and the resulting contractual penalties.
In the region "Rest of Europe" (Europe not including Germany), Biotest grew by 6.9 % year on year over the first three quarters of 2017 to sales of EUR 124.0 million. This positive development was mainly due to increase in plasma sales by EUR 6.8 million (32.6 %). The other regions recorded sales declines, due in particular to the product recall of human albumin, insufficient availability of human albumin and the delay in tender deliveries. Discontinued operations generated sales of EUR 8.3 million in the first nine months of the 2017 financial year.
EBIT of continuing operations totaled EUR -15.7 million in the first three quarters of 2017 after EUR 47.5 million in the same period of the previous year. In the core segment Therapy, EBIT of EUR -26.7 million was generated in the first nine months of the 2017 financial year (previous year: EUR 22.9 million). The main causes for this development were sales reductions of EUR 21.0 million due to the anticipated return of human albumin already delivered and contractual penalties, one-time expenses from write-downs of EUR 8.0 million on inventories of the product human albumin that can no longer be sold due to technical problems in the manufacturing process. In addition to the one-time effects of the recall of human albumin, the limited availability of human albumin and the postponement of tender deliveries had a negative impact on earnings in the Therapy segment. The negative development of EBIT in the Plasma & Services segment was due essentially to sales reductions and compensation expenses in connection with the human albumin recall as well as costs of unutilised capacity relating to the opening of new plasma collection centres in the United States.
EBIT in Other Segments was dominated in the 2017 financial year by consultancy costs in connection with the acquisition of Biotest AG by the Creat Group in the amount of EUR 7 million.
In the first nine months of the 2017 financial year, earnings after taxes of continuing operations in the amount of EUR -22.7 million (same period of the previous year: EUR 13.3 million) were primarily influenced by one-time effects in connection with the recall of the product human albumin.
In research and development, progress has been made in IgG Next Generation studies. Patient recruitment is ongoing in two pivotal studies. Patients with primary immune deficiencies (PID) in Europe and the USA are being treated in the clinical phase III study (no. 991). Patients for the treatment of immune thrombocytopenia (ITP) are treated in the study no. 992 (also clinical phase III), which is being conducted in several European countries.
For Fibrinogen EMA agreed with the positive recommendation of the Paediatric Committee (PDCO) regarding the paediatric development plan for fibrinogen for the indication congenital fibrinogen deficiency. Currently, phase I/III is being supplemented to include children under six years of age. For the indication acquired fibrinogen deficiency, the necessary documents for the approval of the phase III study (no. 995; ADFIRST) were submitted to the Paul Ehrlich Institute (PEI) and the authorities and ethics commissions of other European countries. The PEI has approved the phase III study.
The nine-month report is available on the company's website http://www.biotest.de/ww/en/pub/investor_relations/publications/quarterly_
reports.cfm. The presentation of today's conference for analysts and journalists is available for download from the website. After the conference, an
audio file will be available on the Biotest webpage.
Unless otherwise noted, the amounts stated below relate exclusively to the continuing operations.
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 albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 2,500 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
Dr. Monika Buttkereit
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: Prime Standard
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hanover, Munich, Stuttgart
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.
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