Hansa’s Q224 marked the third consecutive quarter of strong Idefirix sales in kidney transplant, providing some reassurance that the previously slow uptake is now behind us. In the US, the Ph3 ConfideS trial has finished randomisation, with an expected launch in H127. Unlike in the EU, where only 2 clinics participated in the Ph3 study, the US trial has utilised 23 clinics, which will help to accelerate the pace of launch due to greater physician familiarity with Idefirix. Pivotal Ph3 data from ...
Despite 2023 being an eventful year for Hansa, including the advancement of several pipeline programmes, this progress has been overshadowed by the slow patient uptake in kidney transplant, pushing out the anticipated sales inflection to 2027. The company has taken steps to speed up study enrolment in the US, while preserving cash by means of the planned restructuring. In our view, Europe is likely to improve in 2024, with repeat sales expected from all key geographies. Meanwhile, the 5-year sur...
With the European post-approval study (PAS) underway, Hansa is building a solid base of experienced prescribers whom we expect to be converted into commercial users in 2025, after the study ends. We anticipate sales to be lumpy but steady over 2023-24, with an inflection in 2025 driven by the US launch and greater momentum in Europe. We have increased our estimate of Idefirix’s net price in Europe by 20% as more data has emerged, leading to a sales upgrade in outer years. Outside of kidney, Idef...
Hansa is developing and commercializing imlifidase, an enzyme that quickly and precisely cleaves and inactivates IgGs. Imlifidase is approved in Europe as a desensitization agent that enables kidney transplants for patients who otherwise have no chance of finding a match. In the US, an additional trial is ongoing seeking to reproduce these findings, with a low-risk readout expected in 2023/24. Additionally in transplantation, first data for a phase 2 in AMR) is expected in Q4 2022, which we beli...
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