Press Detail





Biotest AG: Biotest increases revenues in first half year 2015 by 8.9%


Biotest AG / Key word(s): Half Year Results

2015-08-11 / 09:00



PRESS RELEASE

Biotest increases revenues in first half year 2015 by 8.9%

- Clinical development of BT-061 will be discontinued

- Capacity expansion at headquarter Dreieich on schedule

- Board of management confirms EBIT guidance of EUR 20-25 million


Dreieich, 11. August 2015. The Biotest Group recorded significant year-on-year sales growth in the first half of 2015. The Group recorded revenue of EUR 287.7 million in the period from January to June 2015, an increase of 8.9 % compared to the same period of the previous year (EUR 264.1 million).

Substantial revenue growth was achieved in the US, Germany and the "Other Asia and Pacific" reporting region in particular. In the US in addition to the increased marketing of Bivigam(R) the sales of plasma increased. Biotest operates plasma collection centers for long-term cooperation partners who are active in other market segments. The Biotest Group is continuing to invest considerable funds in the development of new products and the further development of its existing products. Operating income (EBIT) decreased from EUR 26.5 million to EUR 2.3 million due to these increased research and development costs, costs incurred for the capacity expansion already in progress, unabsorbed costs at the US subsidiary Biotest Pharmaceuticals Corporation (BPC), as well as continued price pressure in individual product areas and regions. The expected moderate earnings performance was seen at the start of the year and was reflected in the forecast for 2015 that was issued in March this year.

The financial result amounted to EUR - 0.2 million (previous year: EUR - 4.8 million). The valuation of a US dollar loan to the US subsidiary BPC at the reporting date has a particularly positive impact here. This resulted in earnings before taxes (EBT) of EUR 2.1 million for the Biotest Group compared with EUR 21.7 million in the previous year.

Earnings after taxes (EAT) were negative at EUR - 2.2 million (previous year: EUR + 13.8 million). The high tax rate is due to the nonrecognition of potential tax assets for losses at the US subsidiary.

Research & development:
Following a detailed analysis of the data from the phase IIb "Treat 2b Study" of tregalizumab (BT-061) for rheumatoid arthritis, BT-061 showed a dose-dependent effect on cells in the immune system which did not translate into clinical efficacy. As a result, Biotest will discontinue the clinical development of tregalizumab (BT-061). Pre-clinical work is currently being performed to determine whether tregalizumab (BT-061) could be of benefit in treating other diseases.

In the current phase I/II study (no. 983), in which the safety and efficacy of indatuximab ravtansine (BT-062) in combination with lenalidomide and dexamethasone are being investigated, recruitment has been completed and the treatment of the 47 patients who had already undergone intensive prior treatment is ongoing. All patients were enrolled in the extension arm of the study investigating the combination with pomalidomide and dexamethasone, and recruitment has been completed. Data will be available end of 2015/ beginning 2016.

The completed phase II study (no. 982) of the IgM Concentrate, a hyperimmunoglobulin with a high content of immunoglobulin M, which was published in late June, showed encouraging results for life-threatening pneumonia in terms of reducing the time spent on ventilation as well as mortality rates. Additional analyses of the study data are currently being performed in preparation for the next phase of clinical development.

The Civacir(R) phase III clinical study is progressing as planed. Final study results are expected to be available by the end of 2015.

Outlook:
The Board of Management confirms its sales forecast as published in the 2014 Annual Report. Following very strong sales growth in the last two financial years, the Board of Management expects an increase in sales in the low single-digit percentage range for this year.

The significant increase in costs and continued price pressure in individual product areas and regions are having a noticeable effect on earnings. In addition, the cost for the planned capacity expansion at the Dreieich site is having a more pronounced impact than in the 2014 financial year. Costs relating to the "Biotest Next Level" expansion project that is now underway will probably be twice as high in 2015 as in 2014. As Biotest works together with partners in developing new preparations, the R&D costs incurred in the current financial year depend to a large extent on the progress made in these projects and the resulting further decisions. Following the discontinuation of the clinical development of tregalizumab (BT-061), the Board of Management is forecasting EBIT in the range of EUR 20 - 25 million as previously announced.

The half-year report can be downloaded from Biotest's website: http://www.biotest.de/ww/en/pub/investor_relations/publications/quarterly_reports.cfm

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.

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 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 rheumatoid arthritis and cancer of plasma cells, which are produced by recombinant technologies. Biotest has more than 2,100 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
email: investor_relations@biotest.de

Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
Listing: Prime Standard
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hannover, München, Stuttgart





2015-08-11 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.
Media archive at www.medientreff.de and www.dgap.de



385253  2015-08-11