Fiscal year 2022 was a banner year for Basilea Pharmaceutica Ltd, with significant revenue contributions from the commercial success of Cresemba and Zevtera and proceeds from oncology transactions. The year was capped off with a pre-NDA meeting held with the FDA for ceftobiprole (Zevtera). The company is now planning to submit an NDA for three indications within two to three months. As part of its strategic refocus, Basilea is also building a balanced R&D portfolio of antibacterial and antifungal drug candidates to support sustainable long-term growth. An ad hoc announcement was made in compliance with Art. 53 LR.
Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company dedicated to the pursuit of better treatments for patients suffering from serious bacterial and fungal infections, is pleased to announce its preliminary financial results for 2022. Additionally, the company has also made great strides with its commercial products, Cresemba® (isavuconazole) and Zevtera® (ceftobiprole), as well as its ongoing R&D efforts.
The revenue contribution from Cresemba, an antifungal, and Zevtera, an antibiotic, is forecasted to reach a combined CHF 122 million in 2022. This amount, along with reimbursements from BARDA, proceeds from oncology transactions and other revenue sources, will bring total revenue to an estimated CHF 148 million. This exceeds the 2022 guidance of CHF 116 million to CHF 122 million.
Basilea made significant strides in 2022 and is committed to continuing the growth of its value creation strategy. Our commercial success, evidenced by Cresemba’s success, and the anticipation of Zevtera’s contribution to revenue with its pending U.S. marketing approval, are paving the way for further in-licensing of preclinical and clinical assets in 2023. Our goal is to build a robust portfolio of innovative drugs to treat bacterial and fungal infections and become a leading anti-infectives company.
By the end of 2022, Cresemba had gained approval in 73 countries and was marketed in 63 – including the United States, China, and many other European countries. This strong global commercial performance triggered a number of milestone payments to Basilea from its partners. 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 a whopping USD 363 million – a 19 percent year-on-year growth!
Anti-infectives key highlights 2022
- Cresemba has made its grand entry into the Chinese market with the launch of both intravenous and oral formulations for treating adult patients suffering from invasive aspergillosis and invasive mucormycosis. This marks a major milestone in providing novel antifungal treatments in one of the world’s most important markets.
- We are delighted to announce the successful completion of our pediatric program, a major milestone that will provide us with an additional two years of marketing exclusivity in Europe and six months in the United States. Patient recruitment for this program has been a huge success, and we are thrilled to be able to move forward with this exciting project.
- In December, Basilea’s partner Asahi Kasei Pharma achieved a major milestone, receiving the marketing approval for Cresemba in Japan. This breakthrough treatment is designed to benefit adult patients suffering from life-threatening fungal infections, including aspergillosis, mucormycosis, and cryptococcosis.
- Basilea recently announced highly encouraging topline results from the phase 3 ERADICATE study, which evaluated ceftobiprole in the treatment of adult patients with bacterial bloodstream infections caused by Staphylococcus aureus (SAB). This successful outcome follows the positive results of the TARGET phase 3 study in acute bacterial skin and skin structure infections (ABSSSI) last year, providing further evidence of the potential for ceftobiprole to provide effective treatment for serious bacterial infections.
- July saw Zevtera celebrate a major milestone, as the healthcare provider was granted marketing authorization by the Brazilian authorities. This exciting development is sure to pave the way for many more success stories in the industry.
Dr. Marc Engelhardt, Chief Medical Officer, is pleased to announce that in Q4 2022, the company had a successful pre-NDA meeting with the U.S. Food and Drug Administration to finalize the regulatory strategy for ceftobiprole in the U.S. Within two to three months, the company will submit a New Drug Application (NDA) to seek approval not only for Staphylococcus aureus bacteremia and acute bacterial skin and skin structure infections, but also for community-acquired bacterial pneumonia. With a broader range of indications, ceftobiprole will be well-positioned to support its utility in a clinical practice setting and meet the unmet medical need.
- Basilea is actively progressing its in-licensed DXR inhibitor program against multi drug-resistant Gram-negative bacteria, aiming to reach the next preclinical decision point in 2023. With this project, the company is making strides towards the development of a potential new treatment for an urgent global health challenge.
- Progress is being made on advancing existing internal programs, bringing us closer to success. We remain committed to making progress and seeing our efforts through to the end.
- Basilea has conducted a detailed evaluation of a lead compound from a recently licensed preclinical program of broad-spectrum antifungals with a new mode of action and, unfortunately, the candidate did not meet the company’s stringent criteria to progress into the development stage. Consequently, Basilea decided to return the program to its licensor.
Dr. Laurenz Kellenberger, Chief Scientific Officer, expressed his enthusiasm for the company’s progress in advancing the pipeline with promising programs. Through the application of our competencies, know-how and data-driven approach to decision making, we have been able to quickly identify and focus on the most promising candidates for further development and in-licensing.
Oncology transactions successfully completed in 2022
In early 2022, Basilea made the strategic decision to focus solely on anti-infectives and exit the oncology space. However, by November of the same year, Basilea had already entered into three separate agreements with innovative oncology companies to acquire novel preclinical stage inhibitors of PARG and CLK, as well as BAL0891 – a potential first-in-class mitotic checkpoint inhibitor. These transactions will not only provide upfront and near-term milestone payments, but also ensure that Basilea stays involved in the long-term value potential of these highly promising programs.
Basilea recently made the strategic decision to transfer the rights for the FGFR inhibitor derazantinib back to Merck & Co. For their tumor checkpoint controller lisavanbulin, the study program was concluded last year, however Basilea is still exploring potential partnering opportunities for the future. As a result of these changes, Basilea will not incur any material costs related to oncology activities in 2023.
At Basilea, we are passionate about finding solutions to the most severe bacterial and fungal infections. Since our founding in 2000, we have made significant strides in developing innovative treatments and have successfully launched two hospital brands, Cresemba for fungal infections and Zevtera for bacterial infections. We are also actively working on our preclinical anti-infective assets to provide even more solutions for patients. Our mission is to provide cutting edge treatments and make a positive impact on the lives of those suffering from these serious illnesses.
Basilea Pharmaceutica Ltd has made certain forward-looking statements regarding their business, such as expectations of progress, timing and completion of research, development and clinical studies for product candidates. However, these statements come with certain risks and uncertainties, and could result in actual results that are different from what was expected. We are making this communication available as of this date and will not be updating any forward-looking statements.