EQS-News: Formycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama®
EQS-News: Formycon AG
/ Key word(s): Statement/Regulatory Admission
Press Release // November 18, 2024 Formycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama®
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard) and its licensing partner Klinge Biopharma GmbH (Klinge) jointly announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB203, a biosimilar candidate to Eylea®1 (aflibercept). Dr. Stefan Glombitza, CEO of Formycon AG, commented: „We are excited about the positive CHMP opinion for FYB203, our biosimilar candidate to Eylea®. As our second ophthalmic biosimilar therapy following the success of our Lucentis®2 biosimilar, FYB203 represents a further advancement in treatment options for serios retinal diseases. After FDA approval in June, this milestone is a testament to the expertise, dedication and hard work of the entire Formycon team and underscores our commitment to enhancing patient care through affordable alternatives. We are now awaiting European Commission approval in the second half of January 2025 and look forward to offering patients a high-quality treatment option that can improve their quality of life.” Under the tradenames AHZANTIVE®3/ Baiama®4 FYB203 has been recommended by the CHMP for approval in Europe for treating adult patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO). Within the approval process, the CHMP’s positive opinion represents an important regulatory step towards the approval of FYB203/ AHZANTIVE®/ Baiama® in the European Union. The CHMP’s scientific assessment report forms the basis for the European Commission’s decision to grant a central marketing authorization valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway, which is expected in the second half of January 2025. Aflibercept inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea® reached global sales of around US$ 9 billion5, confirming its status as the currently best-selling drug in the field of anti-VEGF therapies. FYB203 was approved by the U.S. Food and Drug Administration (FDA) in June 2024. 1) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
About Formycon: About Biosimilars: Contact: Tel.: +49 (0) 89 - 86 46 67 149
18.11.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG. |
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 Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange |
EQS News ID: | 2031583 |
End of News | EQS News Service |
|
2031583 18.11.2024 CET/CEST
Boersengefluester.de (BGFL) provides an overview of the key figures on sales, earnings, cash flow and dividends to help you better assess the fundamental development of the respective companies. All information is entered manually in our database - the source is the respective annual reports. All estimates for future figures are provided by BGFL.
The most important financial data at a glance | ||||||||
2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024e | ||
Sales1 | 42,99 | 33,16 | 34,23 | 36,97 | 42,50 | 77,70 | 62,00 | |
EBITDA1,2 | 8,03 | -1,36 | -4,81 | -12,39 | -15,87 | 1,52 | -22,00 | |
EBITDA-Margin3 | 18,68 | -4,10 | -14,05 | -33,51 | -37,34 | 1,96 | -35,48 | |
EBIT1,4 | 7,13 | -2,27 | -5,73 | -13,33 | -17,73 | -0,37 | -23,40 | |
EBIT-Margin5 | 16,59 | -6,85 | -16,74 | -36,06 | -41,72 | -0,48 | -37,74 | |
Net Profit (Loss)1 | 7,10 | -2,29 | -5,93 | -13,48 | 35,99 | 75,80 | -27,00 | |
Net-Margin6 | 16,52 | -6,91 | -17,32 | -36,46 | 84,68 | 97,56 | -43,55 | |
Cashflow1,7 | 13,30 | -1,48 | -5,10 | -14,18 | -18,88 | -9,85 | 0,00 | |
Earnings per share8 | 0,71 | -0,23 | -0,54 | -1,22 | 2,59 | 4,72 | -1,35 | |
Dividend per share8 | 0,00 | 0,00 | 0,00 | 0,00 | 0,00 | 0,00 | 0,00 |
1 in Mio. Euro; 2 EBITDA = Earnings before interest, taxes, depreciation and amortisation; 3 EBITDA in relation to sales; 4 EBIT = Earnings before interest and taxes; 5 EBIT in relation to sales; 6 Net profit (-loss) in relation to sales; 7 Cashflow from operations; 8 in Euro; Source: boersengefluester.de
Auditor: KPMG
All relevant valuation ratios, dates and other investor information on your share at a glance. Good to know: All data comes from boersengefluester.de and is updated daily. This means you are always up to date. You can get brief explanations of the key figures by moving the cursor or mouse over the relevant field.
INVESTOR-INFORMATION | ||||||
©boersengefluester.de | ||||||
Formycon | ||||||
WKN | ISIN | Legal Type | Marketcap | IPO | Recommendation | Plus Code |
A1EWVY | DE000A1EWVY8 | AG | 906,19 Mio € | 20.12.2010 | Halten | 8FWH4F62+Q8 |
PE 2025e | PE 10Y-Ø | BGFL-Ratio | Shiller-PE | PB | PCF | KUV |
64,13 | 27,32 | 2,35 | 129,22 | 1,80 | -92,02 | 11,66 |
Dividend '2022 in € |
Dividend '2023 in € |
Dividend '2024e in € |
Div.-Yield '2024e in % |
0,00 | 0,00 | 0,00 | 0,00% |
Annual General Meeting | Q1-figures | Q2-figures | Q3-figures | Annual press conference |
12.06.2024 | 08.05.2024 | 13.08.2024 | 28.11.2024 | 25.04.2024 |
Distance 60-days-line | Distance 200-days-line | Performance YtD | Performance 52 weeks | IPO |
+2,05% | +5,10% | -9,04% | -4,65% | +414,39% |
Founded in 2013 by Gereon Kruse, the financial portal boersengefluester.de is all about German shares - with a clear focus on second-line stocks. In addition to traditional editorial articles, the site stands out in particular thanks to a large number of self-developed analysis tools. All tools are based on a completely self-maintained database for more than 650 shares. As a result, boersengefluester.de produces Germany's largest profit and dividend forecast.