Basilea announced this morning that the European Commission has granted a paediatric extension to the company's long-established anti-fungal Cresemba (isavuconazole). The approval is for use in children suffering from invasive aspergillosis or invasive mucormycosis. The immediate impact to Basilea is the receipt of a $10m milestone from European licensee Pfizer.

Importantly, the paediatric extension provides overall market exclusivity for another two years, taking it to Q4 2027. Our forecasts had already assumed Cresemba would receive this approval in the paediatric population and that the loss of exclusivity would occur in both the US and Europe in Q4 2027. It is worth remembering that Cresemba is still early in its launch phase in large markets, including China and Japan.
Much of the recent activity at Basilea has involved replenishing the anti-infectives pipeline with a particular focus on the more lucrative anti-fungal indication. We believe that adding the novel antifungal fosmanogepix, expected to enter Phase 3 evaluation shortly, should take the anti-fungal franchise to new heights given its broad spectrum (including resistant strains), potential for oral delivery, and excellent tissue distribution.
Given its likely broader label with Phase 3 trials scheduled in candidaemia/invasive candidiasis and invasive moulds, our peak sales expectations for fosmanogepix are circa $1.2bn, comfortably exceeding the market potential for Cresemba.
We calculate a discounted cash flow fair value of CHF 105 per share for Basilea.
Please use the link here for all our research and financial forecasts on Basilea.
Subscribe here to receive our research, articles and invitations as soon as they are available.
IMPORTANT:
Calvine Partners LLP is authorised and regulated by the Financial Conduct Authority.
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 in this publication should be considered as any form of advice.
Comments