Autolus Aucatzyl secures UK MHRA approval in r/r adult ALL, all eyes on 1Q25

Last Friday evening, Autolus announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for Aucatzyl (CD19 CAR-T) in adult relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), in line with the expected timeline. Looking ahead, Autolus will report its 1Q25 results on 8 May, where the first quarter US sales of Aucatzyl will be reported and will give us a quantitative view on the launch momentum – note that management provided qualitative comments during the FY24 update stating that the launch is tracking in line with their expectations. While we think first quarter sales are difficult to predict, we do expect good uptake of Aucatzyl in FY25 thanks to its safety advantage (low rates of high grade CRS/ICANS) and positive KOL feedback, and estimate $ 43m in FY25 sales (BBG CSS $ 37m). We reiterate our $10 TP and Buy rating.