Biotest AG: Biotest Group with double digit EBIT growth
Biotest AG / Key word(s): Half Year Results Biotest Group with double digit EBIT growth - Sales increase to EUR 220.2 mio. - EBIT increase by 14.5% to EUR 22.9 EUR mio. - Management confirms guidance 2012 Dreieich, 13 August 2012. The Biotest Group was once again able to increase revenues in the first half of 2012 compared with sales from continuing operations in the same period of 2011. Revenues in the first six months of the year amounted to The higher revenue was mainly attributable to increased volumes, with international markets acting as the principal growth drivers. In addition, further technical optimisation in the production process led to even better results in production. Earnings before interest and taxes (EBIT) also advanced strongly in the first six months. Biotest Group reported half year EBIT of EUR 22.9 million (previous year's period: EUR 20.0 million). This represents a growth of approximately 14.5%. The core business in the Therapy area made a decisive contribution to the positive earnings growth with an increase of almost 36%. The financial result was almost unchanged at -EUR 5.2 million (previous year's period: Major progress was achieved for various development projects in the first half of 2012. These included the submission of the documentation for an additional, new, higher concentrated version of the immunoglobulin Intratect(R) to the Paul-Ehrlich- Institut. The target is to register Intratect(R) 10% in Germany and 18 other EU countries. This is expected to take place in the fourth quarter of 2012 in Germany and in 2013 in the EU. The preparation is to be mainly marketed as an outpatient treatment with higher infusion volumes per therapy session. The further development of the monoclonal antibody Tregalizumab (BT-061), which is being conducted in cooperation with Abbott, is being continued as planned. Also, After the end of the reporting period, Biotest received new information concerning the approval of the immunoglobulin Bivigam(TM) by the United States Food and Drug Administration (FDA). In an official statement no questions were raised on the clinical efficacy and safety of the newly developed investigational polyspecific immunoglobulin preparation by Biotest Pharmaceuticals Corporation, Boca Raton, Florida, USA. Moreover the quality of the already produced batches was accepted by the FDA. However, the letter did not grant the preparation's approval in the USA because FDA requests a new and additional validated test system for detection of thrombogenic activity. Such a test system has not been historically incorporated in the routine batch release process of immunoglobulins, but is now required by the FDA for the approval of our newly developed preparation. An elevated content of thrombogenic factors led to the temporary withdrawal of a competitor's product in Europe and the USA. As consequence, new test methods have been developed over the past months, which still show a large variability. In three renowned international laboratories and within the own quality assurance lab, Biotest could document that Bivigam(TM) did not show any abnormalities regarding this parameter. That means that no higher thrombogenic activity could be detected. In cooperation with a renowned laboratory which is working closely together with FDA, Biotest is currently working on the validation of such a test. The development will presumably need several months. Biotest then expects the FDA marketing approval for Bivigam(TM) in the USA. Despite the delay, Biotest confirms its given guidance for sales and profit in 2012. There is an encouraging growth in business despite the delay in the approval process of Bivigam(TM) and the precaution regarding the valuation of current receivables in Greece. Biotest therefore confirms its guidance provided in the annual report 2011 of a 3-5% rise in revenues and slightly higher operating earnings (EBIT) than in the previous year (EUR 41.6 million). The guidance presupposes that overall economic conditions will continue to be stable in our target markets. The half-year report can be downloaded from Biotest's website: http://www.biotest.de/ww/en/pub/investor_relations/publications/quarterly_reports.cfm Biotest will hold a conference call for journalists and analysts today at 2 p.m. CET: Please find below the dial-in details : Conference ID Biotest 4552378 IMPORTANT: Should you experience any difficulty during the conference, please press *0 on your phone to signal a specialist. The call will available for download on our webpage: www.biotest.de after the conference call. 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. Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.de Securities' ID No., ISIN ordinary shares: 522720, DE0005227201 End of Corporate News 13.08.2012 Dissemination of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.medientreff.de and www.dgap.de |
Language: | English | |
Company: | Biotest AG | |
Landsteinerstraße 5 | ||
63303 Dreieich | ||
Germany | ||
Phone: | 0 61 03 - 8 01-0 | |
Fax: | 0 61 03 - 8 01-150 | |
E-mail: | investor_relations@biotest.de | |
Internet: | http://www.biotest.de | |
ISIN: | DE0005227235, DE0005227201 | |
WKN: | 522723, 522720 | |
Indices: | SDAX | |
Listed: | Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, Hamburg, Stuttgart | |
End of News | DGAP News-Service |
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