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Basilea - Cresemba moving towards approval in Japan

The announcement this morning that Asahi Kasei, Basilea's partner for its anti-fungal Cresemba in Japan has filed an NDA, is a reminder of its continued growth potential.

Japan is an important market for antifungals and Asahi Kasei has a strong hospital presence. Furthermore, we believe that Cresemba's continued success reflects not only its differentiated profile (better safety and extended-spectrum), but also the strength of its partners with Astellas in the key US market and Pfizer in Europe (and other territories) possessing market-leading anti-fungal franchises. Sales have continued to outstrip our expectations so far with end-market sales to June 2021 estimated at $285m representing excellent growth of 24%. Further geographic expansion is planned and Cresemba should be launched in 60 countries by year-end with a target of 70 by end of 2022.

While the commercial allure of new antibiotics may have been blunted by antibiotic stewardship, the need for antifungals remains an important unmet need driven by an increase in the severely immunocompromised patient population largely as a result of aggressive chemotherapy as well as transplantation. The development of new antifungals has been slow and we would highlight the importance of novel therapies reflected by the acquisition of Amplyx by Pfizer to access fosmanogepix (currently in Phase 2). The narrative announcing the acquisition reminded us that no antifungal from a novel class has been approved by FDA for 20 years.

We have previously highlighted the importance of guidelines such as ECIL-6 which positions isavuconazole favourably versus market leader voriconazole in invasive aspergillosis and note that at peak voriconazole generated sales of $900m suggesting more growth to come from Cresemba. As clinical experience with Cresemba increases over time, we anticipate that the willingness of physicians to use this differentiated anti-fungal in the treatment of invasive moulds should increase, particularly should the relevant guidelines evolve and provide a greater emphasis on its use in earlier lines of treatment.

We have calculated a discounted cash flow fair value of CHF120 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.



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