05.11.2020 Formycon AG  DE000A1EWVY8

DGAP-Adhoc: Formycon informs about the modified BLA-Submission Strategy for its Lucentis(R)* Biosimilar-Candidate FYB201


 

DGAP-Ad-hoc: Formycon AG / Key word(s): Miscellaneous/Statement
Formycon informs about the modified BLA-Submission Strategy for its Lucentis(R)* Biosimilar-Candidate FYB201

05-Nov-2020 / 23:07 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.





Publication of insider information in accordance with Article 17 of the Regulation (EU) No 596/2014 Ad-Hoc Announcement /// November 5, 2020

Formycon informs about the modified BLA-Submission Strategy for its Lucentis(R)* Biosimilar-Candidate FYB201

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG ("Bioeq") announced today that the Biologics License Application (BLA) resubmission strategy for FYB201 has been adjusted.

The approval for FYB201 will be requested directly for a large commercial scale. Formycon and Bioeq are in close coordination with the U.S. Food and Drug Administration (FDA). Through the revised submission strategy, Formycon and Bioeq expect a simplification of the approval procedure. The modified submission dossier is expected to be filed with the FDA in the first half of 2021. The adjustment of the regulatory strategy in the course of optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US and European Union countries.

* Lucentis(R) is a registered Trademark of Genentech Inc.

End of Ad Hoc Announcement

About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of antibody-based COVID-19 compounds.

About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection - and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. In 2019, global sales of biosimilars exceeded USD12 billion. Analysts estimate that this figure could rise to around USD 69 billion by 2025.

Contact:
Sabrina Müller
Senior Manager Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
Phone: +49 (0) 89 - 86 46 67 149
Fax + 49 (0) 89 - 86 46 67 110
[email protected] // www.formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.


05-Nov-2020 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


Language: English
Company: Formycon AG
Fraunhoferstraße 15
82152 Planegg-Martinsried
Germany
Phone: 089 864667 100
Fax: 089 864667 110
Internet: www.formycon.com
ISIN: DE000A1EWVY8
WKN: A1EWVY
Indices: Scale 30
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Scale), Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1146012

 
End of Announcement DGAP News Service

1146012  05-Nov-2020 CET/CEST

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Die wichtigsten Finanzdaten auf einen Blick
  2017 2018 2019 2020 2021 2022 2023e
Umsatzerlöse1 29,00 42,99 33,16 34,23 36,97 42,50 81,00
EBITDA1,2 -0,75 8,03 -1,36 -4,81 -12,39 -15,87 -11,00
EBITDA-Marge3 -2,59 18,68 -4,10 -14,05 -33,51 -37,34
EBIT1,4 -1,54 7,13 -2,27 -5,73 -13,33 -17,73 0,00
EBIT-Marge5 -5,31 16,59 -6,85 -16,74 -36,06 -41,72 0,00
Jahresüberschuss1 -1,58 7,10 -2,29 -5,93 -13,48 35,99 52,00
Netto-Marge6 -5,45 16,52 -6,91 -17,32 -36,46 84,68 64,20
Cashflow1,7 -4,17 13,30 -1,48 -5,10 -14,18 -18,88 0,00
Ergebnis je Aktie8 -0,17 0,71 -0,23 -0,54 -1,22 2,59 3,20
Dividende8 0,00 0,00 0,00 0,00 0,00 0,00 0,00
Quelle: boersengefluester.de und Firmenangaben

  Geschäftsbericht 2022 - 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: PanTaxAudit

INVESTOR-INFORMATIONEN
©boersengefluester.de
Formycon
WKN Kurs in € Einschätzung Börsenwert in Mio. €
A1EWVY 46,350 Halten 818,40
KGV 2025e KGV 10Y-Ø BGFL-Ratio Shiller-KGV
17,83 29,21 0,60 -1.495,16
KBV KCV KUV EV/EBITDA
2,30 - 19,26 -50,96
Dividende '22 in € Dividende '23e in € Div.-Rendite '23e
in %
Hauptversammlung
0,00 0,00 0,00 12.06.2024
Q1-Zahlen Q2-Zahlen Q3-Zahlen Bilanz-PK
30.05.2023 30.08.2023 13.11.2023 27.04.2023
Abstand 60Tage-Linie Abstand 200Tage-Linie Performance YtD Performance 52 Wochen
-6,64% -18,53% -17,82% -31,33%
    
Weitere Ad-hoc und Unternehmensrelevante Mitteilungen zu Formycon AG  ISIN: DE000A1EWVY8 können Sie bei EQS abrufen


Biotechnologie , A1EWVY , FYB , XETR:FYB