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Basilea - Japanese NDA for Cresemba

With the development of novel oncology therapies such as the FGFR inhibitor derazantinib and the mitotic checkpoint inhibitor lisavanbulin, the ongoing potential of the anti-infectives portfolio can often be overlooked. In particular, sales of Basilea's antifungal Cresemba (isavuconazole) have been better than initial expectations thanks to its extended-spectrum, good safety profile and also the excellent existing franchises of key commercial partners Astellas (US) and Pfizer (EU, APAC & China). Sales through distributors have also helped deliver impressive growth in the overall isavuconazole franchise.

Basilea has enjoyed considerable success with Cresemba, which is approved for the treatment of invasive mould infections. The importance of new antifungal classes has largely been overlooked, with few new classes evident. There is a small number of antifungal classes, an increasing problem of resistance to existing agents, a rising population of immunosuppressed patients and the associated high mortality rate. There may be a lack of government initiatives to encourage the development of new antifungals (compared to antibiotics). Still, the pharmaceutical industry has been more enthusiastic, reflected in the partnerships secured by Basilea and end-product sales of approximately $266m (to end March 2021).

One of the key territories missing from Cresemba's impressive list (currently approved in nearly 60 and marketed in 53 countries) is Japan. With Phase 3 development recently completed by partner Asahi Kasei Pharma in deep-seated mycoses, an NDA filing is now on the near-term horizon. Basilea's anti-infectives out-licensing has allowed the company to invest behind the oncology portfolio. Management has progressed derazantinib in various challenging cancers (biliary, bladder and gastric) and lisavanbulin, which promises to transform the treatment of glioblastoma. When Cresemba is approved in Japan, Basilea will receive up to CHF60m in regulatory and sales milestones as well as double-digit tiered royalties on sales.

Furthermore, the 5th generation cephalosporin antibiotic ceftobiprole is progressing through Phase 3 development in the key US market (largely funded by BARDA). Ceftobiprole already has a positive result in severe skin infections (TARGET), with the ERADICATE study ongoing in the challenging bacteraemia (SAB) indication. Both studies require a positive result for a regulatory filing. We look forward to data later in 2021 and a further enhancement of the anti-infectives franchise at Basilea.

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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