Basilea raises full-year guidance 2026 and financial target for Agenda 2030

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 fosmanogepix2, 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.”

For further information, please contact:

Peer Nils Schröder, PhD
Head of Corporate Communications & Investor Relations
+41 61 606 1102
media_relations@basilea.com
investor_relations@basilea.com