Press Detail





Biotest AG: Biotest Group with double digit EBIT growth


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

13.08.2012 / 10:00



PRESS RELEASE

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
EUR 220.2 million, a rise of around 3.4% on the previous year's figure of EUR 212.9 million. This amount also contains EUR 8.3 million of scheduled and proportionally booked payments from Abbott in connection with the Tregalizumab (BT-061) agreement (previous year EUR 9.1 million).

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:
-EUR 5.1 million). Biotest Group reported total earnings before taxes (EBT) on Continuing Operations of EUR 17.7 million in the first half of 2011 (a rise of 18.8 % on the previous year figure of EUR 14.9 million). Earnings after tax (EAT) on the other hand fell from
EUR 10.9 million to EUR 9.9 million. The higher tax rate primarily reflected the non-valuation for tax purposes of the Greek subsidiary's losses and the Brazilian subsidiary's start-up losses. Overall the earnings per share on Continuing Operations amounted to EUR 0.84.

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,
BT-062, an immunoconjugate for use in haematology therapy, made progress during the period under review, as e.g. the start of a combination study in the US.

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
Germany: + 49 (0) 6103 485 3001
United Kingdom + 44 207 153 2027
USA + 1 480 629 9673

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.

About Biotest

Biotest is a provider of pharmaceutical and biotherapeutic 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 application 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. Biotest also researches into the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and cancer of plasma cells. Biotest has more than 1.600 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,
e-mail: investor_relations@biotest.de
fax: +49 (0) 6103 801-347

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



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181370  13.08.2012