Continued strong Cresemba® (isavuconazole) sales by Astellas in the U.S. trigger CHF 20 million sales milestone payment to Basilea

Ad hoc announcement pursuant to Art. 53 LR

Basel/Allschwil, Switzerland, January 09, 2023

Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the continued strong sales of the antifungal Cresemba^® (isavuconazole) achieved by its partner Astellas Pharma Inc. (“Astellas”) in the United States in 2022 exceeded the threshold triggering a milestone payment of CHF 20 million to Basilea.

David Veitch, Chief Executive Officer of Basilea, said: “We are very pleased with the continued commercial success of Cresemba. This milestone reflects the strong sales growth in 2022 in the U.S. and confirms that Cresemba is addressing a high medical need and plays an important role in the treatment of patients suffering from invasive mold infections.”

Under the license agreement with Astellas, Basilea is entitled to receive milestone payments based on Astellas exceeding certain net sales thresholds in the United States within a calendar year. Total sales milestone payments from Astellas to date amount to CHF 50 million, including the CHF 20 million triggered now. Basilea is eligible for additional sales milestone payments of up to CHF 240 million, in addition to tiered, double-digit royalties on U.S. net sales.

Cresemba is approved in 71 countries to date and is currently marketed in 63 countries, including the United States, China, most EU member states 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 months between October 2021 and September 2022, amounted to USD 363 million, a 19 percent growth year-on-year.¹

About isavuconazole (Cresemba)

Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba. Basilea has entered into several license and distribution agreements for isavuconazole including the United States, Europe, China, Japan, Latin America, Asia-Pacific, the Middle East and North Africa region, Canada, Turkey and Israel. Cresemba is approved in the United States for patients 18 years of age and older for the treatment of invasive aspergillosis and invasive mucormycosis.² It is also approved in the European Union and several additional countries in Europe and beyond, including China and Japan.³ Cresemba has orphan drug designation in the U.S., Europe and Australia for its approved indications.

About invasive aspergillosis and invasive mucormycosis

Invasive aspergillosis and invasive mucormycosis are life-threatening mold infections that predominantly affect immunocompromised patients, such as patients with hematologic malignancies (blood cancer). Both infections are associated with high morbidity and mortality.

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 several preclinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit .

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 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.

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This ad hoc announcement can be downloaded from .

References

1. IQVIA Analytics Link, September 2022. In-market sales reported as moving annual total (MAT) in U.S. dollar.
2. Cresemba [Accessed: January 08, 2023]
3. The registration status and approved indications may vary from country to country.

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