The financial result at Basilea reflects a strong performance from the anti-infectives portfolio and Cresemba in particular as previously announced. Guidance for 2022, reflects the continued importance of Cresemba. The bigger surprise, however, has been the decision to rein in ambitions in oncology and to focus on the anti-infectives franchise.
To be fair, the FGFRi space has become increasingly competitive and despite potential differentiation, it has apparently proven challenging to recruit patients into the first-line setting in the FIDES-02 clinical study in the urothelial cancer indication. This must be frustrating given the potential differentiation offered by derazantinib, particularly in combination, potentially boosting the activity of checkpoint inhibition. Patients in the 2nd-line setting have already been enrolled and this cohort will continue to maturity. With the decision to de-prioritise urothelial cancer, it will be the gastric and biliary cancer indications that will be the focus, with important data due in H1 2022 in FIDES-03. Importantly, these will be the first data from the higher 400mg dose. Data are also anticipated from lisavanbulin in glioblastoma.
We look forward to further details on the plan to split the businesses. The cost associated with continued in house development of derazantinib, with its potential in other FGFR-driven tumours, and the rapid pace of development elsewhere, suggests that a commercial partner was a pre-requisite to fully explore and exploit derazantinib's potential. The result of ERADICATE study for ceftobiprole in bacteraemia (SAB), due by mid-year 2022, has become central to Basilea's long-term anti-infectives ambitions. As a reminder, a positive Phase 3 result in both severe skin infections, as well as SAB, are required for US regulatory approval.
Following the decision to split the two businesses, Basilea is now guiding for a 30% reduction in operating expenses in 2023 vs 2022, a transition to sustainable profitability and the generation of positive cashflow from operations.
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Basilea Pharmaceutica is a client of Calvine Partners, and as such, this publication is not independent and should be considered a marketing communication under FCA Rules. None of the information contained in this publication should be considered as any form of advice.