Basilea reports preliminary 2022 revenues, exceeding guidance, and provides portfolio update Continued commercial success of Cresemba and Zevtera in 2022 generated revenue contributions of approx. CHF 122 million, exceeding guidance by more than 17% Significant proceeds from oncology transactions
Following pre-NDA (New Drug Application) meeting held with FDA in Q4 2022 for ceftobiprole (Zevtera), NDA submission for three indications planned within two to three months Building a balanced R&D portfolio of antibacterial and antifungal drug candidates to support sustainable long-term growth in line with strategic refocus
Ad hoc announcement pursuant to Art. 53 LR
Basel/Allschwil, Switzerland, January 11, 2023
Revenue contributions from the antifungal Cresemba and the antibiotic Zevtera are expected to amount to approximately CHF 122 million (full-year 2022 guidance: CHF 98 million – 104 million). Total revenue, which includes BARDA reimbursements1, proceeds from the oncology transactions and other revenue contributions in addition to the Cresemba and Zevtera contributions, is expected to amount to approximately CHF 148 million (full-year 2022 guidance: CHF 116 million – 122 million). David Veitch, Chief Executive Officer, commented: “We achieved significant milestones in 2022 and will continue to focus on delivering on our strategy to drive value creation going forwards. This is supported by the continued commercial success, especially of Cresemba and, subject to receiving a marketing approval in the U.S, the anticipated increasing revenue contributions from Zevtera. We are also planning to in-license further preclinical and clinical assets in 2023 and beyond. Our goal is to maintain a balanced portfolio of innovative drug candidates for the treatment of severe bacterial and fungal infections to support the long-term growth of Basilea, beyond Cresemba and Zevtera, and in so doing execute on our strategic goal of becoming a leading anti-infectives company.” The strong global commercial performance of Cresemba triggered a number of separate sales milestone payments to Basilea from its partners, related to Cresemba in-market sales; in the United States, Asia Pacific & China, Canada and the Nordics. By year-end 2022, Cresemba was approved in 73 countries and marketed in 63 countries, including the United States, most EU member states, China and additional countries inside and outside of Europe. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between October 2021 and September 2022 amounted to USD 363 million, a 19 percent growth year-on-year.2 Anti-infectives key highlights 2022
Patient recruitment was completed for the pediatric program. The completion of the pediatric program is a requirement for gaining an additional two years of marketing exclusivity in Europe and six months in the United States.
In July, Zevtera received the marketing authorization in Brazil. The work on an in-licensed DXR inhibitor program against multi drug-resistant Gram-negative bacteria progressed and Basilea expects to reach the next preclinical decision point in 2023. Progress on advancing earlier internal programs continues.
Basilea has completed the profiling of a lead compound from a recently in-licensed preclinical program of broad-spectrum antifungals with a new mode of action. The candidate did not meet Basilea’s stringent criteria for progressing into the development stage and the company decided to return the program to the licensor. Dr. Laurenz Kellenberger, Chief Scientific Officer, commented: “We made good progress advancing our pipeline with promising programs, from both internal and external innovation. Our competencies and know-how in research and development of anti-infectives, combined with a data-driven approach and decision making process allows us to quickly identify and then focus on the most promising candidates for further development and for in-licensing.”
Oncology transactions successfully completed in 2022
In February 2022, Basilea announced the strategic decision to focus exclusively on anti-infectives going forwards and to exit oncology by the end of 2022. By November 2022, Basilea had entered into three separate transactions with innovative oncology companies. These transactions related to novel preclinical stage inhibitors of PARG and CLK as well as BAL0891, a potential first-in-class mitotic checkpoint inhibitor. They were structured to provide upfront and near-term milestone payments, while also ensuring that Basilea maintains an ongoing participation in the long-term value creation potential of these promising programs. On the oncology assets which were not transacted, Basilea decided to transfer the rights for the FGFR inhibitor derazantinib back to Merck & Co. For the tumor checkpoint controller lisavanbulin, Basilea concluded the study program last year, following a decision not to expand glioblastoma patient cohorts, retaining the option to explore partnering opportunities in the future. Basilea will not incur material costs related to any oncology activities in 2023. 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 several preclinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. 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 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 to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd 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. For further information, please contact:
Head of Corporate Communications & Investor Relations
Switzerland Phone +41 61 606 1102 E-mail media_relations@basilea.com
investor_relations@basilea.com
This ad hoc announcement can be downloaded from www.basilea.com.
IQVIA Analytics Link, September 2022. In-market sales reported as moving annual total (MAT) in U.S. dollar.
ERADICATE study: Clinicaltrials.gov identifier NCT03138733
TARGET study: ClinicalTrials.gov identifier NCT03137173