30.11.2021 Biotest AG  DE0005227235

DGAP-News: Biotest AG: Biotest receives approval for Intratect(R) in France


 

DGAP-News: Biotest AG / Key word(s): Regulatory Approval
Biotest AG: Biotest receives approval for Intratect(R) in France

30.11.2021 / 07:00
The issuer is solely responsible for the content of this announcement.


PRESS RELEASE

Biotest receives approval for Intratect(R) in France

  • Approval in last major European immunoglobulin market in which Biotest has not yet had approval
  • Biotest starts nationwide commercialisation for future sales growth of Intratect(R)
  • Immunoglobulin market in France has sales volume of 550 million EUR


Dreieich, 30 November 2021 Biotest AG today announces the marketing authorisation in France for the human intravenous immunoglobulin preparation Intratect(R), which is manufactured and marketed by Biotest in two concentrations (50 g/l and 100 g/l). The regulatory process (Repeat Use Procedure) and the approval of Intratect(R) in France were completed in a very short time.

Intratect(R) is an important component of Biotest's portfolio with over 50 approvals worldwide. The broad spectrum of indications includes substitution therapy for primary and secondary immunodeficiency diseases as well as immunomodulation for primary immunothrombocytopenia, Guillain-Barré syndrome, Kawasaki syndrome, chronic inflammatory demyelinating polyradiculoneuropathy and multifocal motor neuropathy.

Due to a shortage of human intravenous immunoglobulin preparations in France, Biotest has already been marketing Intratect(R) in both concentrations since spring 2021 on the basis of a national exemption. "We are very pleased that we can now further expand the marketing of Intratect(R) on the basis of a regular marketing authorisation in France" emphasises Henrik Oehme, Head of Region Middle East, Africa & France, "with the approval of Intratect(R), there is now another human intravenous immunoglobulin preparation in France, which helps to ensure a continuous supply of this vital preparation for patients."

The demand for immunoglobulin preparations in France is approximately 10 tonnes per year. "We thank the French authorities for their cooperation in partnership, which allows us to make our contribution to the supply of patients in France", says Dr Olivier Samama, Managing Director of Biotest France SAS.

About Intratect(R)
Intratect(R) is a polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIG). The ready-to-use solution is suitable for replacement therapy in primary and secondary antibody deficiency syndrome as well as for immunomodulation in autoimmune diseases such as ITP, GBS, CIDP, MMN and Kawasaki syndrome. Dosage and duration of treatment depend on the indication and the severity of the disease.

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 care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 1,900 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

IR contact
Dr Monika Buttkereit
Phone: +49-6103-801-4406
Mail: [email protected]

PR contact
Dirk Neumüller
Phone: +49-6103-801-269
Mail: [email protected]

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: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

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.



30.11.2021 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.

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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: [email protected]
Internet: http://www.biotest.de
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1252664

 
End of News DGAP News Service

1252664  30.11.2021 

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Die wichtigsten Finanzdaten auf einen Blick
  2016 2017 2018 2019 2020 2021 2022e
Umsatzerlöse1 553,10 378,10 400,30 419,10 484,20 515,60 0,00
EBITDA1,2 86,60 13,00 35,20 30,50 28,30 -16,10 0,00
EBITDA-Marge3 15,66 3,44 8,79 7,28 5,84 -3,12 0,00
EBIT1,4 63,90 -9,30 10,60 -1,20 -1,30 -47,10 0,00
EBIT-Marge5 11,55 -2,46 2,65 -0,29 -0,27 -9,14 0,00
Jahresüberschuss1 -45,70 -3,50 181,70 -4,70 -31,40 -63,40 0,00
Netto-Marge6 -8,26 -0,93 45,39 -1,12 -6,48 -12,30 0,00
Cashflow1,7 65,90 34,30 -50,00 -33,60 -16,70 33,90 0,00
Ergebnis je Aktie8 -1,17 -0,40 4,58 -0,11 -0,72 1,59 -0,35
Dividende8 0,07 0,04 0,04 0,04 0,04 0,04 0,04
Quelle: boersengefluester.de und Firmenangaben

  Geschäftsbericht 2021 - Kostenfrei herunterladen.  
1 in Mio. Euro; 2 EBITDA = Ergebnis vor Zinsen, Steuern und Abschreibungen; 3 EBITDA in Relation zum Umsatz; 4 EBIT = Ergebnis vor Zinsen und Steuern; 5 EBIT in Relation zum Umsatz; 6 Jahresüberschuss (-fehlbetrag) in Relation zum Umsatz; 7 Cashflow aus der gewöhnlichen Geschäftstätigkeit; 8 in Euro; Quelle: boersengefluester.de

Wirtschaftsprüfer: KPMG

INVESTOR-INFORMATIONEN
©boersengefluester.de
Biotest VZ
WKN Kurs in € Einschätzung Börsenwert in Mio. €
522723 33,000 Halten 1.491,84
KGV 2023e KGV 10Y-Ø BGFL-Ratio Shiller-KGV
50,77 21,06 2,43 -540,98
KBV KCV KUV EV/EBITDA
3,44 38,52 2,89 -115,57
Dividende '20 in € Dividende '21e in € Div.-Rendite '21e
in %
Hauptversammlung
0,04 0,04 0,12 05.05.2022
Q1-Zahlen Q2-Zahlen Q3-Zahlen Bilanz-PK
05.05.2022 11.08.2022 14.11.2022 24.03.2022
Abstand 60Tage-Linie Abstand 200Tage-Linie Performance YtD Performance 52 Wochen
-6,46% -10,17% -14,51% -7,04%
    
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Gesundheit , 522723 , BIO3 , XETR:BIO3