FY'23 has been a year of excellent financial and strategic execution. FY'23 revenues of CHF157.6m were once again dominated by strong growth of anti-fungal Cresemba as it continued its international roll out.
Although Cresemba may be entering a more mature phase of growth in historically key markets such as the US and Europe, it has only recently been introduced into new and important markets of China and Japan, which together represent 26% of the market for invasive fungal infections. Overall spending has been well contained, and even with the acquisition of Fosmanogepix, Basilea generated an operating profit of CHF19.2m, well ahead of revised guidance. At the end of FY'23, Basilea had CHF64.3 m in cash and equivalents. Guidance for FY'24 looks reassuring, with revenues expected to grow to CHF183m and the company to remain profitable, with operating profit set to increase by 55% to CHF30m along with further debt reduction.
During the year, we have been particularly impressed by management's execution of its in-licensing strategy, as the company has sought to extend the anti-infectives franchise and prepare for the loss of Cresemba exclusivity from Q4 2027 in both the US and Europe. The acquisition of the novel anti-fungal fosmanogepix promises to transform the outlook for the anti-fungal franchise given its profile with strong clinical data already generated in patients with Candida auris and in patients with candidaemia as well as invasive fungal infections (IFI). Planning for Phase 3 development is already well advanced, with two Phase 3 studies scheduled to begin in FY'24 in candidaemia/invasive candidiasis as well as invasive fungal infections. The candidaemia study is scheduled to start in mid-2024, and the IFI study by the end of 2024. Importantly, Basilea should be in a strong position to gauge the commercial profile of fosmanogepix by the time Cresemba is facing loss of exclusivity.
Elsewhere the antibacterial franchise at Basilea has come to the fore with the forthcoming FDA action date for its longstanding 5th generation cephalosporin antibiotic ceftobiprole scheduled for April 3rd. As a reminder, we believe that ceftobiprole should be an important addition to the anti-infective physicians' armamentarium, particularly as it relates to the treatment of bacteraemia caused by Staphyloccocus aureus (SAB), particularly where MRSA is suspected, given the lack of effective treatment options. In order to achieve its commercial potential, Basilea is seeking a relevant partner for ceftobiprole in the US before the FDA action date. we look forward to the identity of the partner and the financial terms secured by Basilea.
The antibacterial franchise has also been boosted by in-licensing activity which has involved highly novel approaches. Tonabacase looks to be a strong contender as a novel phage-derived endolysin-based approach which could potentially overcome resistance concerns associated with traditional antibiotics. Additionally, tonabacase should work synergistically with existing antibiotics, including ceftobiprole. Additionally, although ceftobiprole has limited Gram-negative coverage, the acquisition of the OMPTA programme promises to significantly broaden Basilea's exposure to the development of important Gram-negative infections, which represent four of the six ESKAPE pathogens.
FY'23 has been a year of effectively de-risking the long-term growth of Basilea's anti-infective ambitions. We look forward, in particular, to fosmanogepix entering late-stage trials as well as the introduction of ceftobiprole to an expectant US SAB market opportunity. With more deals planned to further flesh out the anti-infective pipeline, there is much to look forward to.
Following the recent in-licensing and acquisition activities, our previous discounted cash flow fair value of CHF91 is under review.
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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 in this publication should be considered as any form of advice.