Simon Baker's questions to Autolus Therapeutics (AUTL) leadership • Q2 2025
Question
Simon Baker of Rothschild & Co Redburn asked how the reimbursement process for cell therapies differs from traditional drugs, affecting the launch sequence in Europe. He also asked for perspective on the UK's new framework for point-of-care manufacturing.
Answer
CEO Christian Itin provided a detailed explanation of the challenges in European reimbursement for cell therapies, citing a major disconnect between regulators who approve drugs based on single-arm trials and market access bodies whose methodologies require randomized controlled data. This systemic issue, where the models cannot quantify the benefit of curative therapies, complicates pricing and launch sequencing, making the traditional Germany-first approach less certain.