Basilea raises full-year guidance 2026 and financial target for “Agenda 2030” and provides updates on late-stage clinical programs

Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland, October 27, 2026

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it is raising its financial guidance for the full year 2026 and the cumulative cash flow target for 2026-2030 from its commercialized products within the strategic initiative, “Agenda 2030”. The company also provided updates on the progress of its late-stage clinical programs for ceftibuten-ledaborbactam and fosmanogepix, ahead of its Capital Markets Day taking place tomorrow in Zurich.

David Veitch, Chief Executive Officer, said: “The sustained momentum of our commercial business reinforces the financial foundations of our “Agenda 2030” and enhances our capacity to continue to invest in future growth. By 2030, we aim to establish a diversified business with four commercialized products and an industry-leading anti-infectives R&D pipeline. We look forward to engaging with investors, analysts and media at tomorrow`s Capital Markets Day in Zurich as we outline the next phase of Basilea’s growth.”

Adesh Kaul, Chief Financial Officer, added: “Cresemba’s continued strong growth underscores the quality and durability of our commercial franchise. The significant increase in expected milestone income allows us to raise our full-year 2026 guidance for Cresemba and Zevtera-related income to CHF 250 million, 19% above our previous guidance. Given Cresemba’s sustained momentum, we are also increasing our “Agenda 2030” target for cumulative cash flow from Cresemba and Zevtera from CHF 600 million to CHF 650 million. This enhanced outlook strengthens our ability to fund future growth initiatives.”

Regarding the update of the late-stage clinical program for ceftibuten-ledaborbactam, Dr. Marc Engelhardt, Chief Medical Officer, stated: “Our recent consultations with the FDA and EMA have provided greater clarity on a streamlined clinical development pathway for ceftibuten-ledaborbactam and the data package required to support our targeted positioning: aiming for a broad, unrestricted use for patients with complicated urinary tract infections. As a result, we are now planning a phase 2/3 study under one study umbrella, without a separate confirmatory phase 3 study, and remain on track to initiate this study mid-2027. This approach will require fewer patients than running a program with two separate phase 3 studies and offers the opportunity for a data readout from the phase 2 part as early as end-2028. We are currently focused on completing the remaining preparatory work, including; finalizing the phase 2/3 study protocol, completing the ongoing phase 1 study providing further tolerability and safety data¹, complementary PK/PD analysis and securing clinical trial material.”

On the progress of its late-stage clinical program for fosmanogepix^{2, 3}, he added: “Our global phase 3 program for fosmanogepix progresses toward data readouts in mid-2028. We have successfully completed recruitment into the salvage therapy cohort of the invasive mold infection study, marking another important program milestone, while recruitment continues in the mold study’s other cohorts and in the invasive candidiasis study. Our goal is to maximize the potential of fosmanogepix by pursuing the broadest possible label at launch. We therefore plan to include results from both phase 3 studies in our initial regulatory filings.”

Increased full-year 2026 revenue guidance and raised cumulative cash flow target for “Agenda 2030”

Basilea provides the following updated guidance for the full year (FY) 2026 versus FY 2025:

• Cresemba and Zevtera-related revenue is now expected to increase to CHF ~250 million (versus CHF ~210 million previous guidance) with a cash contribution of CHF ~215 million (versus CHF ~180 million previous guidance). Milestone payments are now expected to reach CHF ~65 million (versus CHF ~35 million previous guidance).
• Within “Agenda 2030”, this results in an expected increase of cumulative cash flow from Cresemba and Zevtera from 2026 to 2030 to CHF 650 million (previously: CHF 600 million).

Basilea conducts Capital Markets Day tomorrow in Zurich, October 28, 2026

The event will provide the audience with a comprehensive update on the company’s strategic direction and value drivers and will include presentations from senior management and external experts. For further details on the agenda and registration, please visit https://basilea-cmd.com/#E4A948

About Basilea

Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Fosmanogepix and ceftibuten-ledaborbactam

These projects have been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA). Fosmanogepix is funded under OT number: 75A50124C00033 and ceftibuten-ledaborbactam under contract 75A50123C00050. The contracts and federal funding are not an endorsement of the study results, product, or company.

For further information, please contact:

This ad hoc announcement can be downloaded from www.basilea.com.

References

1. ClinicalTrials.gov identifier: NCT06733675
2. FAST-IC (Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis: ClinicalTrials.gov identifier: NCT05421858
3. FORWARD-IM (FOsmanogepix study Run Worldwide as Antifungal treatment in Resistant Disease caused by Invasive Molds): ClinicalTrials.gov identifier: NCT06925321
   

Attachment

• Press release (PDF)