Formycon AG (DE:FYB) has reported record H118 revenues, boosted by the one-off transfer of FYB202 into a joint venture with Aristo Pharma and payments stemming from the out-licensed assets FYB201 and FYB203. We believe that Formycon biosimilars FYB201 (Lucentis) and FYB203 (Eylea) are set to enter neovascular age-related macular degeneration (nAMD) market post-2020. Cash and equivalents at end-H118 were €11.8m and should give a cash runaway until 2020 based on H118 cash burn. Formycon guides for FY18 revenues of €35m.
FYB201 on track to lead Lucentis biosimilars
In May 2018, Formycon announced that the primary endpoint in the COLUMBUS-AMD Phase III study of FYB201 had been met. The last patient completed treatment in June 2018; Formycon expects to release further information in H218. Partner Bioeq IP (which holds exclusive global rights to FYB201 in a €100m+ deal) will use these data for regulatory filings in the US and EU, and aims to launch the product in 2020 (US) and 2022 (EU) on patent expiration(s). Global Lucentis sales increased in H118 to $1.9bn (H117: $1.7bn), but have fallen since H114 ($2.1bn), reflected in part by the increased use of Eylea and continued off-label use of Avastin in nAMD. We believe this may introduce some uncertainly into the sales of Lucentis, but think the case for a low-cost alternative in the form of a biosimilar of the branded Lucentis remains strong.
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