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Original-Research: Formycon AG - from First Berlin Equity Research GmbH
Classification of First Berlin Equity Research GmbH to Formycon AG
First Berlin Equity Research has published a research update on Formycon AG (ISIN: DE000A1EWVY8). Analyst Simon Scholes reiterated his BUY rating and increased the price target from EUR 80.00 to EUR 82.00. Abstract: Formycon and its commercialisation partner, Fresenius Kabi, announced the approval of the Stelara biosimilar FYB202 in both the EU and the US on 27 September. In its most recent corporate presentation, Formycon flagged decisions by the EU and US regulatory authorities on whether to approve FYB202 for early Q4/24 and September 2024 respectively. The timing of the announcements was thus widely anticipated in the market. The unexpected element in the news on FYB202 was the announcement that Formycon/Fresenius Kabi now have the right to market FYB202 in the US no later than 22 February 2025 (previously no later than 15 April). As far as we can ascertain, there have been no changes in competitors' launch dates and so Formycon/Fresenius Kabi will be joint third (previously fifth) in a queue of seven companies seeking to launch a Stelara biosimilar in the US market between 1 January and 15 May next year. We think this earlier launch date perceptibly improves FYB202's market share prospects and so have raised our forecasts, and the price target for the Formycon share from €80 to €82. We maintain our Buy recommendation. First Berlin Equity Research hat ein Research Update zu Formycon AG (ISIN: DE000A1EWVY8) veröffentlicht. Analyst Simon Scholes bestätigt seine BUY-Empfehlung und erhöht das Kursziel von EUR 80,00 auf EUR 82,00. Zusammenfassung: Formycon und sein Kommerzialisierungspartner Fresenius Kabi gaben am 27. September die Zulassung des Stelara-Biosimilars FYB202 sowohl in der EU als auch in den USA bekannt. In seiner jüngsten Unternehmenspräsentation kündigte Formycon Entscheidungen der EU- und US-Zulassungsbehörden über die Zulassung von FYB202 für Anfang Q4/24 bzw. September 2024 an. Der Zeitpunkt der Ankündigungen wurde daher vom Markt weitgehend erwartet. Das unerwartete Element in den Nachrichten zu FYB202 war die Ankündigung, dass Formycon/Fresenius Kabi nun das Recht haben, FYB202 in den USA bis spätestens 22. Februar 2025 zu vermarkten (vorher bis spätestens 15. April). Soweit wir feststellen können, haben sich die Einführungsdaten der Wettbewerber nicht geändert, so dass Formycon/Fresenius Kabi als drittes (bisher fünftes) Unternehmen in einer Reihe von sieben Unternehmen, die zwischen dem 1. Januar und dem 15. Mai nächsten Jahres ein Stelara-Biosimilar auf den US-Markt bringen wollen, an der Reihe sein werden. Wir sind der Meinung, dass dieses frühere Einführungsdatum die Marktanteilsaussichten von FYB202 spürbar verbessert und haben daher unsere Prognosen und das Kursziel für die Formycon-Aktie von €80 auf €82 angehoben. Wir behalten unsere Kaufempfehlung bei. Bezüglich der Pflichtangaben gem. §85 Abs. 1 S. 1 WpHG und des Haftungsausschlusses siehe die vollständige Analyse. You can download the research here: http://www.more-ir.de/d/30981.pdf Contact for questions: First Berlin Equity Research GmbH Herr Gaurav Tiwari Tel.: +49 (0)30 809 39 686 web: www.firstberlin.com E-Mail: g.tiwari@firstberlin.com
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1999941 01.10.2024 CET/CEST
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