Basel/Allschwil, Switzerland, February 07, 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 performance of the antifungal Cresemba^® (isavuconazole) by its license partner Pfizer Inc. (NYSE: PFE, “Pfizer”) in the Asia Pacific region and China exceeded the threshold triggering a sales milestone payment of USD 1.25 million.

David Veitch, Basilea’s Chief Executive Officer, stated: “We are very pleased that Cresemba sales in Asia Pacific and China are growing fast, resulting in the achievement of the second sales milestone payment within eight months and underscoring the significant commercial potential of the brand in this region. Cresemba is well on track to become a leading global brand for the treatment of patients with invasive mold infections.”

The license agreement between Basilea and Pfizer for Cresemba covers Europe (excluding the Nordic countries) as well as countries in the Asia Pacific region and China. Under the agreement, Basilea is eligible for additional regulatory and sales milestone payments of up to around CHF 580 million, in addition to receiving mid-teen royalties on sales.

Cresemba is approved in 73 countries to date and is currently marketed in 63 countries, including the United States, 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, 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 In China, the oral and intravenous formulations are approved for the treatment of adult patients with invasive aspergillosis and invasive mucormycosis. It is also approved in the United States and several additional countries in Europe and beyond, including Japan.³ Cresemba has orphan drug designation in the US, 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 preclinical anti-infective assets 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 Basilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b 4123 Allschwil Switzerland
Phone	+41 61 606 1102
E-mail	media_relations@basilea.com investor_relations@basilea.com

This press release can be downloaded from www.basilea.com.

References

IQVIA Analytics Link, September 2022. In-market sales reported as moving annual total (MAT) in US dollar.European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu [Accessed: February 06, 2023]The registration status and approved indications may vary from country to country.

Attachment

Press release (PDF)