DGAP-Adhoc

​​​​​​​PAION ANNOUNCES EXCLUSIVE LICENSING AGREEMENT WITH LA JOLLA PHARMACEUTICAL FOR GIAPREZA(TM) (ANGIOTENSIN II) AND XERAVA(TM) (ERAVACYCLINE) IN EUROPE - Seite 2

Under the terms of the license agreement, PAION has the exclusive right to commercialize GIAPREZA(TM) and XERAVA(TM) in the Territories, while bearing all future associated costs for the development, market authorization and distribution in the Territories.

La Jolla will receive a USD 22.5 million upfront license fee payment. In addition, La Jolla is entitled to receive additional payments of up to USD 109.5 million contingent upon the achievement of certain commercial milestones, the majority of which are predicted upon reaching significant sales revenues. La Jolla is also entitled to royalties on PAION's own net sales in Europe in the amount of 15% for XERAVA(TM) and between 18% and 24% for GIAPREZA(TM) and a share of revenues from indirect sales.

PAION will use current cash at hand of close to EUR 22 million (as of today) to settle the upfront payment and will draw the first two tranches of the loan facility from the European Investment Bank (EIB) in the amount of EUR 12.5 million. The third tranche from the EIB loan in the amount of EUR 7.5 million is expected to be available shortly.

With the addition of two more hospital products to its commercial portfolio, PAION has made the final decision to build out its own commercial structure in Europe to commercializeGIAPREZA(TM) and XERAVA(TM) together with Byfavo^(R) after its potential market approval in Europe.

A Market Approval Application (MAA) for Byfavo^(R) for procedural sedation is currently under review by the European Medicines Agency (EMA). PAION expects that the CHMP (Committee for Medicinal Products for Human Use) will publish its recommendation on the MAA by the end of January 2021. The European Commission will review the CHMP recommendation and a final decision is expected in the first half of 2021. PAION plans to have launched all three products by the end of 2021.

PAION will require additional funds to commercialize its product portfolio in selected European markets. The total funds required will depend on the structure of the commercial/distribution setup, as well as the magnitude and timing of incoming milestone and royalty payments from remimazolam licensees. These milestone and royalty payments could partially cover the funding requirements. Furthermore, PAION is looking into complementary financing measures to cover the funds required in the next years.