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Hyloris entered into a late-stage research and development program in collaboration with AFT to introduce an injectable iron deficiency therapy (HY-094) to the global market – development costs and net margin from sales and licensing will be distributed equally. This announcement brings a new later stage product to the company's pipeline, for which Hyloris expects phase 3 development to start in the near-term. Given the size of the market, we expect this will be a high volume product and Hyloris will need to find a commercialisation partner with a large footprint. We note that Hyloris previous...
Hyloris reported FY24 results with YE24 cash of € 23.6m (YE23: € 30.4m). Revenue grew to € 8.5m (from € 2.1m), though we note this included one-off milestone payments ($ 2.1m as well as an additional undisclosed amount). We are encouraged by the planned 9 regulatory submissions by YE26, though point out that US filing fees range $ 2-4m. Additionally, Hyloris will require extra funding to commercialise the near-term cardiology products in the US and is exploring multiple options. As such, while we acknowledge the company's operational progress, we'll look to see how Hyloris' funding plans evolv...
Yesterday before US market open, Autolus reported 1Q25 results with the highlight being the first Aucatzyl (CD19 CAR-T) sales in r/r adult ALL in the US ($ 9m), coming in above our expectations (1Q25 KBCSe $ 5m) and sending the stock up +10%. We see the stronger than expected initial demand as a good sign for the remainder of the launch. Seasonality remains to be seen, but if this momentum continues for the rest of FY25, our sales estimate of $ 43m will be within reach (BBG CSS $ 37m). We reiterate our $ 10 TP and Buy rating for this significantly undervalued stock.
: AED BB, BPOST BB, COFB BB, MONT BB, ONTEX BB, PROX BB, UCB BB, VGP BB, AUTL US, ECMPA NA
UCB received Japanese approval for two self-administration methods for Rystiggo (anti-FcRn) in generalised myasthenia gravis (gMG), allowing patients to use an infusion pump or manual syringe at home after training. To support the label expansion, UCB also launched a home delivery service in Japan to enhance patient convenience and satisfaction. The move aligns with Rystiggo's self-administration approval in the EU earlier this year and could support its positioning amid growing competition. We foresee € 2.2bn peak sales for Rystiggo by 2033, and reiterate our € 214 TP/Accumulate.
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