Formycon announces binding Term Sheet between Klinge Biopharma and Coherus BioSciences for the exclusive commercialization of FYB203, a biosimilar candidate to Eylea®1, in the United States

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/CIMERLI^TM3in 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⁾CIMERLI^TMis a trademark of Coherus BioSciences, Inc.

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Another five biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com/

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare providers. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

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T + 49 89 86 46 67 149
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