2025 has proven to be another year of excellent execution, both financially and operationally. Cresemba delivered another strong financial performance, generating total revenue of CHF232.4m, ahead of our expectations (CP CHF225m). Royalty income increased by 15.4% to CHF111.6m, with costs carefully controlled. FY’25 represented another profitable year, and Basilea ended the year with cash and equivalents of CHF 162.3m (net cash CHF 86.9m).
Agenda 2030 in focus
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Basilea has sought to reflect its confidence in its long-term growth ambitions by setting out the likely financial and operational profile of the business for 2030 (Agenda 2030). Cresemba may be maturing in the US and Europe, and the company has indicated the potential for generics in the US from Q4 ’27 and Europe from H2 ’28. However, today’s release confirms the expectation of strong sales potential outside the US and Europe, with Japan in particular highlighted. Basilea anticipates generating CHF600m in cumulative cash flows over the next five years from sales of Cresemba and Zevtera, highlighting that Zevtera is expected to gain momentum in the key US market from Q2 this year. Further upside to the Agenda 2030 projection could come from later-than-anticipated Cresemba generics and first sales of fosmanogepix and ceftibuten-ledaborbactam. We also note that it is Basilea’s ambition to have four commercial assets by 2030, with the company clearly possessing sufficient firepower to advance the current pipeline and add relevant programmes.
Burgeoning pipeline with significant sales potential
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For us, Basilea already has the programmes required to add longevity to the antifungal pipeline and deliver long-term growth. While Cresemba is now the leading global antifungal by sales (end-market sales of CHF693m in 12 months to end September), we believe that fosmanogepix could comfortably exceed Cresemba given its broader activity against almost all of the priority fungal infections highlighted by the WHO. Our model suggests peak sales of circa CHF $1.2bn. Importantly, we believe that the development risk has already been substantially reduced through a combination of Phase 2 data and positive real-time data emerging from the ongoing expanded access programmes. From a timing perspective, we note that the Phase 3 programme is well underway, with FAST-IC (candidaemia including candidiasis) and FORWARD-IM (invasive moulds) due to read out at the beginning of 2028. The importance of fosmanogepix as a novel antifungal has been reflected in the FDA conferring Fast Track status for various invasive fungal infections, including invasive aspergillosis (IA), candidiasis and mucormycosis. Following on behind is BAL2062, which looks to be an important treatment option in the IA indication. Importantly, a large chunk of the development of these programmes (and others) should be facilitated by non-dilutive BARDA funding.
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Zevtera gaining traction
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Thanks to Agenda 2030, Zevtera's sales progress in the US should provide a helpful guide for bridging the gap between Cresemba’s loss of exclusivity and the approval of fosmanogepix. Zevtera is commercially available through a highly relevant US licensee, Innoviva Specialty Therapeutics (IST). As a reminder of its importance to peak sales potential, the US market represents a key geography where AMR remains problematic and where Zevtera has proven efficacy against MRSA. Here, Zevtera is the only cephalosporin specifically approved for the treatment of Staphylococcus aureus bacteraemia (SAB). Further, there is recognition that there are limited treatment options. Vancomycin and daptomycin both suffer from concerns regarding emerging resistance and the need for monitoring. We remain encouraged by Zevtera's importance to the IST portfolio.
We forecast a peak sales potential of $380m, primarily driven by the bacteraemia (SAB) indication. Encouragingly, Zevtera has already secured repeat orders from major US hospitals, suggesting positive clinical experience. We look forward to future commercial updates, noting the strong clinical experience and the expectation that momentum will increase from Q2 this year.
Antibiotic franchise looking good
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The addition of the Phase 3-ready combination ceftibuten-ledaborbactam from Venatorx has significantly strengthened the late-stage pipeline and represents an important addition to the antibiotic development pipeline. The objective is to successfully deliver an oral therapy for the treatment of cUTIs caused by Enterobacterales. We previously suggested that this is a validated approach, supporting a lower-risk Phase 3 programme. Given the importance of Agenda 2030, we note the ongoing efforts to ensure the Phase 3 programme is suitably well prepared, particularly given our expectation of rapid enrolment rates. As a reminder, ceftibuten-ledaborbactam is expected to enter Phase 3 in Q1 2027. We have previously suggested that a conservative 10% market share could generate peak sales of circa $450m. Given the combination of positive Phase I and susceptibility data, and our belief that this is a validated approach, we previously introduced sales from 2029F, albeit with a conservative 60% probability of success.
In-licensing efforts continue
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Unsurprisingly, the release today confirms the company’s intention to deliver additional programmes into its already burgeoning pipeline. We suspect that the company’s confidence in this regard should have been bolstered by its success to date and by BARDA's support in providing non-dilutive funding. While the existing early-stage pipeline may not be particularly relevant to the Agenda 2030 ambition, we believe that there is considerable potential. For example, the novel antifungal BAL2062 has completed its preclinical profiling, with further regulatory discussions expected in 2026 as the company seeks to optimise clinical development. BAL2420 represents a novel approach to developing a first-in-class antibiotic targeting LptA, with the potential to treat important Gram-negative infections effectively. BAL2420 is expected to enter the clinic in H1 2026. In-licensing and collaborations remain important, as noted above for ceftibuten-ledaborbactam, as well as the Phare Bio and Prokaryotics relationships, which are delivering meaningful innovation to the anti-infectives pipeline. Furthermore, we remain of the view that Basilea has become a natural partner of choice for anti-infective companies keen to expedite the commercialisation of their anti-infective programmes
2026 guidance reassuring
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Financial guidance for 2026 suggests another strong performance, driven by Cresemba, with revenues expected to increase by 10%. R&D investment will increase as fosmanogepix progresses through Phase 3 and the addition of the (almost) Phase 3-ready ceftibuten-ledaborbactam, although much will be offset by BARDA payments. Despite the expected 20% increase in R&D, Basilea is guiding to a 20% increase in operating profitability. Overall, we believe the future looks bright with a balanced pipeline of antifungal and antibiotic programmes. While we expect further in-licensing activities, we remain highly encouraged by execution so far.
Our forecasts are currently under review.
Well placed for the future
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While today's release focuses mainly on achievements in 2025, the evident progress reflects an extended period of successful delivery as the company seeks to become a global anti-infectives powerhouse. Clearly, Cresemba's ongoing success through licensees, particularly in the US and Europe, has been a major driver of its financial performance. Since launch 10 years ago, it has achieved the lofty heights of treating 500k patients worldwide with 12-month sales to the end of September 2025 reaching $693m, confirming its position as the leading anti-fungal by value.
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With Cresemba facing loss of exclusivity in the US and Europe from Q4 2027, Basilea has been assiduous in diversifying revenues and strengthening its late-stage pipeline. We have previously highlighted the importance of the US launch of the 5th-generation cephalosporin antibiotic, Zevtera (ceftobiprole), through a highly relevant partner, IST. We look forward to additional updates as the US launch continues. We also note encouraging progress in securing successful reimbursement and access pathways. Additionally, repeat orders from major hospitals suggest a positive user experience from early adopters. Undoubtedly, the bacteraemia indication (SAB) is the key driver, accounting for around $250m of our $380m peak sales forecast.
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The addition of the Phase 3-ready combination ceftibuten-ledaborbactam from Venatorx significantly strengthens the late-stage pipeline, with the objective of developing an oral therapy for the treatment of cUTIs caused by Enterobacterales. We believe this to be a validated approach, suggesting a lower-risk endeavour. The news release confirmed that Basilea is on track to initiate the Phase 3 programme in Q1 2027, with efforts this year focusing on regulatory interactions and securing sufficient supply to enable the trial to be conducted expeditiously. There is already an expectation of rapid patient enrolment rates. We have previously suggested that a conservative 10% market share could generate peak sales of circa $450m. Given the combination of positive Phase I and susceptibility data, and our belief that this is a validated approach, we previously introduced sales from 2029F, albeit with a conservative 60% probability of success.
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While still early days, there are clear signs of progress in strengthening the earlier-stage pipeline. The novel antifungal BAL2062 completed its preclinical profiling, with further regulatory discussions expected in 2026 as the company seeks to optimise clinical development. BAL2420 represents a novel approach to developing a first-in-class antibiotic targeting LptA, with the potential to treat important Gram-negative infections effectively. BAL2420 is expected to enter the clinic in H1 2026. In-licensing and collaborations remain important, as noted above for Venatorx, as well as the Phare Bio and Prokaryotics relationships, which are delivering meaningful innovation to the anti-infectives pipeline. We anticipate further agreements as Basilea rapidly becomes a potential partner of choice for anti-infective companies keen to expedite the commercialisation of their anti-infective programmes.
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Equally important has been the company's ability to access non-dilutive funding. In particular, the award of a large multi-year OTA with BARDA has undoubtedly further enhanced Basilea’s ambitions, providing funding (approximately 60% of development costs) and flexibility. The transfer to Basilea of BARDA funding for ceftibuten-ledaborbactam has further cemented the importance of this source of non-dilutive funding. However, it should be noted that Basilea could have self-funded these programmes from existing cash flow. We suspect that BARDA’s support has highlighted the company’s anti-infectives prowess to potential partners seeking an experienced development partner in the complex anti-infectives field.
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Of the above accomplishments, we remain particularly excited by the prospects for fosmanogepix. Given its profile and despite the intensifying competitive landscape, fosmanogepix has the potential to be an even larger commercial success than Cresemba. Fosmanogepix also holds promise in the context of IV to oral step-down therapy to provide outpatient treatment options. At the same time, its activity against almost all of the fungi on the WHO critical list suggests a broader label than Cresemba and should help maximise commercial success. Moreover, its activity against resistant strains and its ability to penetrate important organs (particularly CNS) better than currently available antifungal classes should result in fosmanogepix featuring strongly in treatment guidelines.
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With Phase 3 now fully underway, enrolment is progressing, and the company has confirmed that both trials are progressing as planned, with topline results expected in H1 2028. In the interim, we look forward to updates from the ongoing expanded access programme, noting that with over 400 patients already experiencing the lifesaving benefits of fosmanogepix before approval, there is the distinct possibility that more patients may have received fosmanogepix to treat challenging (often life-threatening) infections in a real-world setting than in the Phase 3 programme. These data should certainly provide comfort regarding the commercial applicability of fosmanogepix and hopefully result in an accelerated roll out once approved.
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Financially, despite its significant commitment to R&D, Basilea remains a profitable company with a royalty stream that consistently delivers double-digit growth, reflecting the high quality and recurring nature of Cresemba revenues. Moreover, the addition of BARDA revenues, offsetting up to 60% of the costs of key late-stage programmes (fosmanogepix, BAL2062 and ceftibuten-ledaborbactam), provides significant financial flexibility.
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Our forecasts continue to assume that Cresemba sales will start to decline in both the US and Europe after the expiry of exclusivity in Q4 2027. Key to the longer-term outlook for Cresemba will be the recent launches in important markets, such as China and Japan, which represent substantial opportunities and account for approximately 18% of the global market.
Although licensing efforts cannot compensate for the lost Cresemba sales in 2028, we should have fosmanogepix Phase 3 data, which should provide further clarity on the long-term outlook for Basilea's anti-infectives franchise. Before that, we expect confidence in the Phase 3 programme's positive outcome to grow. Hopefully, additional EAPs will provide further insight into the potential of fosmanogepix in other needy treatment settings. We have previously highlighted the extremely encouraging results of the fusarium patient subset published by NEJM. Additionally, it is worth remembering the open-label nature of the Phase 3 trial in invasive moulds, suggesting the potential for de-risking as the trial progresses.
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With Phase 3 trial data yet to come, our forecasts still reflect a risk-adjustment of 75%. Given the Phase 2 data and the excellent EAP success, this approach seems conservative. Nevertheless, risks remain. Post-launch, we hope that, given the activity of fosmanogepix along with the global nature of the Phase 3 programme, fosmanogepix will enter markets outside the US and Europe on a timelier basis than Cresemba did.
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Our forecasts are aligned with guidance for 2025F and suggest a period of strong positive cash flow and sustainable profitability. Given the scale of operating loss carry forwards, we do not anticipate tax payments for the next several years. The addition of BARDA funding now offsets a significant portion of the R&D spend and will be received through other revenue streams. For now, however, we have not included sales from BAL2062 or BAL2420, as we suspect they are beyond our forecast time horizon in any case. Also, the timing of future milestone commitments for the fosmanogepix in-licensing has yet to be detailed. However, Basilea has been adept at managing costs while aggressively pursuing the creation of a world-leading anti-infective franchise.
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