Strong Cresemba® (isavuconazole) sales by Astellas in the U.S. trigger CHF 15 million sales milestone payment to Basilea

Ad hoc announcement pursuant to Art. 53 LR

Basel, Switzerland, January 07, 2022

Basilea Pharmaceutica Ltd. (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with infectious diseases and cancer, announced today that sales of the antifungal Cresemba^® (isavuconazole) by its partner Astellas Pharma Inc. (“Astellas”) in the United States exceeded the threshold triggering a milestone payment to Basilea of CHF 15 million.

David Veitch, Chief Executive Officer of Basilea, said: “We are very pleased with the continued commercial success of Cresemba. This significant milestone payment reflects the strong sales growth in 2021 in the U.S. and confirms the important role that Cresemba plays 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, including the CHF 15 million triggered now, amount to CHF 30 million and Basilea is still eligible for additional sales milestone payments of up to CHF 260 million, in addition to tiered, double-digit royalties on U.S. sales.

Cresemba has been approved in more than 60 countries to date and is currently marketed in 56 countries, including the United States, most EU member states and additional countries inside and outside of Europe. In the twelve months between October 2020 and September 2021, total in-market sales of Cresemba amounted to more than USD 300 million, a 26.5 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 covering the United States, Europe, China, Japan, Latin America, Asia-Pacific, the Middle East and North Africa region, Canada, Russia, 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 Cresemba is also approved in the European Union and several additional countries in Europe and beyond.³ It has orphan drug designation in the U.S., Europe and Australia for its approved indications.

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 cancer and infectious diseases. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of severe bacterial infections. We are conducting clinical studies with two targeted drug candidates for the treatment of a range of cancers and have several preclinical assets in both cancer and infectious diseases 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. 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:

Peer Nils Schröder, PhD Head of Corporate Communications & Investor Relations
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.

References

1. IQVIA, September 2021. In-market sales reported as moving annual total (MAT) in U.S. dollar.
2. Cresemba U.S. prescribing information [Accessed: January 06, 2022]
3. The registration status and approved indications may vary from country to country.

Attachment

• Press release (PDF)

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