Hyloris FDA approval for Tranexamic Acid Intravenous Premix RTU

Hyloris announced that its partner Avenacy received FDA approval for its ANDA (generic NDA) of Tranexamic Acid Intravenous Premix Ready-to-Use (RTU), with launch planned for 2H25. This product, approved through the generic ANDA pathway, is non-core for the company, as Hyloris' main focus is on the more valuable reformulation and repurposing 505(b)(2) pathway. Sales of intravenous tranexamic acid reached $ 29.1m in the 12 months up to March 2025, and we estimate Hyloris could receive approx. $ 2m in income from the RTU presentation at peak based on the profit sharing agreement with Avenacy in the US. Given this is a non-core asset with a small contribution, we reiterate our € 5 TP and Hold rating.