Munich – Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of FYB203, Formycon’s biosimilar candidate to Eylea® (aflibercept), informed Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today, that it has entered into a binding term sheet with Coherus BioSciences, Inc. (“Coherus”) for the exclusive commercialization of FYB203 in the United States (U.S.). The parties expect to complete the transaction in Q1 2023.

FYB203 is being evaluated in a Phase III clinical trial (MAGELLAN-AMD) and topline results are expected within the next few weeks. Coherus plans to file a Biologics License Application with the U.S. Food and Drug Administration (FDA) later this year and intends to launch the product at Eylea® biosimilar market formation, currently expected in 2025, if approved.

Under the binding term sheet, Coherus will make a total upfront payment to Klinge of approximately €30 million, comprised of cash and Coherus common stock, thirty days after the execution of the definitive agreements. Coherus will also make other regulatory and launch milestone payments and share profits approximately equally with Klinge in consideration for the commercialization rights to FYB203 in the United States. Formycon is entitled to participate in all Klinge income under the agreement with Coherus in the mid-single to low-double-digit-percentage range.

Coherus is already marketing Formycon’s ophthalmic Lucentis®2 biosimilar FYB201/CIMERLITM3 in the U.S. and can therefore leverage on established sales channels and an existing commercial infrastructure in the ophthalmic space for the commercialization of FYB203.

1)Eylea® is a registered trademark of Regeneron Pharmaceuticals, Inc.

2)Lucentis® is a registered trademark of Genentech, Inc.

3)CIMERLITM is a trademark of Coherus BioSciences, Inc.