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Formycon AGForGermany / Biopharmaceuticals Xetra RATINGBUYPRICE TARGET € 52.00 Bloomberg: FYB GR Return Potential 37.2%ISIN: DE000A1EWVY8 FYB201 achieves primary end point of phase III trial Risk Rating HighSUCCESS OF FYB201 PHASE III TRIAL IS A MAJOR MILESTONE Simon Scholes, Tel. +49 (0)30 - 80 93 96 94 FINANCIAL HISTORY & PROJECTIONS 2014 2015 2016 2017E 2018E 2019E Revenue (€ m)12.67 17.15 19.66 28.20 29.30 24.20 Y-o-y growth 29.7% 35.4% 14.6% 43.4% 3.9% -17.4% EBIT (€ m)0.87 0.54 -4.07 0.11 0.15 -4.67 EBIT margin 6.9% 3.1% -20.7% 0.4% 0.5% -19.3% Net income (€ m)0.86 0.58 -4.07 0.29 0.36 -4.50 EPS (diluted) (€)0.10 0.06 -0.45 0.03 0.04 -0.48 DPS (€)0.00 0.00 0.00 0.00 0.00 0.00 FCF (€m)-0.63 -0.24 -6.40 1.87 -1.01 -5.82 Net gearing -70.4% -81.6% -66.9% -81.2% -76.5% -65.1% Liquid assets (€ m)9.22 20.30 13.97 21.34 20.34 14.51 RISKS Product failures, lack of funding, change in regulatory environment, new product innovations making biosimilars obsolete COMPANY PROFILEFormycon AG is a Munich, Germany based pharmaceuticals company specializing in the development of biosimilars, e.g. generic versions of biotechnology products. MARKET DATAAs of 02 May 2018Closing Price € 37.90Shares outstanding 9.34mMarket Capitalisation € 354.13m52-week Range € 28.30 / 39.32Avg. Volume (12 Months) 11,823Multiples 20162017E2018EP/E n.m. n.m. n.m. EV/Sales 17.312.011.6EV/EBIT n.m. n.m. n.m. Div. Yield 0.0% 0.0%0.0% STOCK OVERVIEW26.828.830.832.834.836.838.840.8Apr-17Jun-17Aug-17Oct-17Dec-17Feb-18Apr-18450500550600Formycon AGDAXsubsector BiotechnologyCOMPANY DATAAs of 30 Jun 2017 Liquid Assets € 14.42mCurrent Assets € 16.84mIntangible Assets € 0.89mTotal Assets € 21.25mCurrent Liabilities € 1.60mShareholders’ Equity € 17.98mSHAREHOLDERSInstitutional Investors 50.0%Founders and Management 20.0%Free Float 30.0%FYB201 has achieved the primary endpoint of its phase III trial, thereby keeping Formycon on track to reach its target that its biosimilar products will be the first to market following the expiry of the patents on their reference products from 2020 onwards. We have raised our price targetfrom €48.00 to €52.00 to reflect the reduction in risk entailed by this news. We maintain our Buy recommendation. Success of FYB201 phase III trialFormycon has announced that based on interim results FYB201 has achieved the primary endpoint of its phase III trial. The primary endpoint of the trial is confirmation of comparable efficacy between FYB201 and the reference product, Lucentis, in the indication neovascular age-related macular degeneration. FYB201 is the furthest advanced of the biosimilar candidates Formycon is currently developing. Bioeq GmbH began recruitment of patients for a global phase III trial with the compound in February 2016. The last patient in the trial, in which patients are treated for a total of 48 weeks, is expected to complete treatment later in the current quarter. We expect the release of final results from the trial during Q3 of this year and the submission of a Biologics License Application (BLA) to the FDA in either Q4 2018 or Q1 2019. Patent expiry for Lucentis is June 2020 in the US and January 2022 in the EU.Formycon’s management expects that the company’s biosimilar products will be the first to market following the expiry of the patents on their reference products from 2020 onwards. The news that FYB201 has achieved the primary endpoint of its phase III trial keeps Formycon on track to achieve this goal. Combined Lucentis/Eylea sales up 9.3% in 2017 Formycon is focused on the “third wave” of biosimilars, i.e on biosimilars whose reference products go off patent after 2020. Besides FYB201, the company currently has three other biosimilars under development as shown in figure 1 overleaf. The reference product for FYB203 is Eylea. (p.t.o.)
 
aus der Diskussion: Formycon AG - Informationssammelthread
Autor (Datum des Eintrages): Snoopy9  (03.05.18 13:35:03)
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