Continued strong Cresemba® (isavuconazole) sales by Pfizer trigger USD 10 million sales milestone payment to Basilea

Ad hoc announcement pursuant to Art. 53 LR

Basel, Switzerland, December 08, 2021

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 Pfizer in Europe, Russia and Israel exceeded the threshold triggering a milestone payment to Basilea of USD 10 million. This is the second sales milestone payment by Pfizer in 2021.

David Veitch, Chief Executive Officer of Basilea, said: “The second 10 million U.S. dollar sales milestone payment by our partner Pfizer, within less than twelve months, confirms that the need for Cresemba continues to increase rapidly. Together with our partners, we at Basilea are determined to make Cresemba available to increasing numbers of patients around the world.”

The license agreement between Basilea and Pfizer covers Europe (excluding the Nordic countries), Russia, Turkey and Israel, as well as China (including Hong Kong and Macao) and sixteen countries in the Asia Pacific region. Basilea is entitled to receive milestone payments upon Pfizer’s cumulative Cresemba sales in Pfizer’s licensed territories exceeding certain thresholds. Pfizer is commercializing Cresemba in most European countries as well as in a number of countries in the Asia Pacific region. Total milestone payments from Pfizer to Basilea amount to USD 38 million to date and Basilea remains eligible for milestone payments of up to approximately USD 610 million, in addition to receiving mid-teen royalties on net sales.

Cresemba has been approved in more than 60 countries to date and is currently marketed in 55 countries, including the United States, most EU member states and additional countries inside and outside of Europe. In the twelve-month period between July 2020 and June 2021, total "in-market" sales of Cresemba amounted to USD 285 million, a 24 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. In the 27 European Union member states, as well as in Iceland, Liechtenstein, Norway and the U.K., isavuconazole is approved for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.² Cresemba is also approved in the United States 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 a number of 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, June 2021. In-market sales reported as moving annual total (MAT) in U.S. dollar.
2. European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu [Accessed: December 07, 2021]
3. The registration status and approved indications may vary from country to country.
   
   

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