The importance of the anti-fungal Cresemba has grown in recent years as the company has re-focussed on growing and developing its anti-infectives franchise. As we have noted previously, success has been due to Cresemba's differentiated profile, which comprises a broad spectrum and a benign safety profile, but also to the strong anti-infectives franchises at its commercial partners which include Astellas and Pfizer in major markets.
The announcement of a CHF20m milestone from Astellas thanks to ongoing strong sales progress in the US, follows on from CHF15m at the start of FY2022 (CHF 50m received from Astellas to date) and reflects the ongoing importance of this market to overall Cresemba sales. Basilea has noted that a further CHF240m of additional sales based milestone payments are possible under the existing US relationship.
Cresemba is approved in the US for the treatment of invasive aspergillosis (IA) and invasive mucormycosis. Cresemba is also approved in the EU (and other countries) to treat adult patients with invasive aspergillosis, and adult patients with mucormycosis for whom amphotericin B is inappropriate. IA is a life-threatening infection with a high mortality rate, resulting in potential hospitalisation of up to one month, and represents the major opportunity for Cresemba. Although mucormycosis is rarer, its prevalence is increasing rapidly. Mucormycosis results in unacceptable morbidity and mortality (90-100% in neutropenic patients and through disseminated infection) - it is a burden to the US healthcare system, costing circa $100,000 per patient.
Cresemba targets a growing market driven by an increase in the severely immunocompromised patient population, primarily due to aggressive chemotherapy and organ transplantation. The development of new antifungals has been slow, and we have previously highlighted the importance of novel therapies - for which Basilea is an active participant with the April 2022 licensing of a novel anti-fungal candidate from Fox Chase Chemical Diversity Center. This need for new antifungals was reflected by Pfizer's acquisition of Amplyx in 2021 to access fosmanogepix, which reminded us that the FDA has not approved an novel antifungal for 20 years. In this regard, we note the FDA Action date for F2G's Olorofim of June 17th 2023.
Cresemba has been a highly rewarding success story for Basilea, its licensees, and distributors alike. We forecast continued growth in major markets despite Cresemba's maturity, largely due to an increasing number of at-risk immunosuppressed patients. Cresemba has also enjoyed a protracted rollout as Basilea has identified new distributors and licensing partners. Currently, Cresemba is approved in 71 countries, of which it is marketed in 63. End market sales in the 12 months to September 2022 were $363m, representing 19% growth, with the vast majority coming from Astellas in the USA. In particular, we have highlighted the potential for growth receiving a boost from recent approvals in China (in particular) as well as Japan which should provide further longevity to the overall Cresemba franchise.
We calculate a discounted cash flow fair value of CHF 91 per share for Basilea.
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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.