Continued strong Cresemba® (isavuconazole) sales by Pfizer trigger USD 26 million sales milestone payments to Basilea

Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland, June 08, 2023

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, reported today that sales of the antifungal Cresemba^® (isavuconazole) by its license partner Pfizer in Europe and the Asia Pacific and China regions, respectively, exceeded thresholds that triggered two separate milestone payments totaling USD 26.25 million to Basilea.

David Veitch, Chief Executive Officer of Basilea, said: "These sales milestone events confirm that Cresemba continues to serve a medical need in patients suffering from life-threatening invasive mold infections in many countries across the globe.”

Based on the license agreement between Basilea and Pfizer, Basilea is entitled to receive milestone payments upon Pfizer’s cumulative Cresemba sales exceeding certain thresholds, in Europe (excluding the Nordic countries), as well as in China and sixteen countries in the Asia Pacific region. Under the terms of the agreement, Basilea remains eligible for milestone payments of up to approximately CHF 515 million, in addition to receiving mid-teen royalties on net sales.

Cresemba has been approved in 73 countries to date and is currently marketed in 67 countries, including the United States, most EU member states and additional countries inside and outside of Europe. In 2022, total global in-market sales of Cresemba amounted to USD 373 million, a 15 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 approximately 115 countries. 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 adult patients with mucormycosis for whom amphotericin B is inappropriate.² Isavuconazole is also approved in the United States and several additional countries in Europe and beyond, including Japan and China.³ It has orphan drug designation in the US, 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 severe bacterial or 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, Allschwil 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, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil 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 press release can be downloaded from www.basilea.com.

References

1. IQVIA Analytics Link, December 2022. In-market sales reported as moving annual total (MAT) in US dollars.
2. European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu [Accessed: June 07, 2023]
3. The registration status and approved indications may vary from country to country.

Press release (PDF)