EQS-Adhoc: Formycon AG announces global license agreement with Fresenius Kabi for FYB202, a biosimilar candidate to Stelara®1 (ustekinumab)

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Publication of inside information pursuant to Article 17 of Regulation (EU) No 596/2014
Ad hoc announcement // February 1, 2023

Formycon AG announces global license agreement with Fresenius Kabi for FYB202, a biosimilar candidate to Stelara^®1 (ustekinumab)

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), as the exclusive owner of the global commercial rights to FYB202, a biosimilar candidate to Stelara^® (ustekinumab), today announced the conclusion of a global license agreement with Fresenius Kabi AG (“Fresenius Kabi”). Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets.

Upon conclusion of the agreement Formycon receives an upfront payment as well as milestone payments contingent on the successful achievement of certain regulatory events which are expected to total in the mid double digit million Euro range. Post-commercialization value will be shared approximately equally by both companies. Semi-exclusive commercialization rights for Germany as well as rights for parts of the MENA² region and Latin America remain with Formycon.

In August 2022, Formycon published positive interim results for efficacy for FYB202 from the clinical phase III study VESPUCCI. In the extended phase I pharmacokinetics study, the recruitment of study subjects was successfully completed in October 2022. European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023.

FYB202 is a proposed biosimilar referencing Johnson & Johnson’s Stelara®, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders. Stelara® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis.

¹⁾ Stelara^® is a registered trademark of Johnson & Johnson
²⁾ Middle East and North Africa

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This document and the information contained herein are for informational purposes only and do not constitute a prospectus or an offer to sell or a solicitation of an offer to buy any securities of the Company in the United States of America ("USA") or any other jurisdiction. This publication may not be distributed, published or circulated in the United States, Australia, Canada or Japan. The securities of the Company may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended (the "Securities Act"). The Company's securities have not been and will not be registered under the Securities Act or the applicable securities laws of Australia, Canada or Japan. There will be no public offering of shares of the Company.

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About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. Formycon AG is listed in the Open Market ("Scale") of the Frankfurt Stock Exchange (ISIN: DE000A1EWVY8 / WKN: A1EWVY).

About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2025, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Currently, global sales of biosimilars are estimated at more than USD 15 billion. By 2030, analysts estimate that this figure could rise to over USD 60 billion.

Contact:
Sabrina Müller
Senior Manager Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com // www.formycon.com

1549005  01-Feb-2023 CET/CEST