Medigene AG: Medigene sells US-rights for Veregen® and raises financial guidance 2017

– Positive impact on financial guidance 2017: Revenue EUR 10.5-11.5 m (previous guidance: EUR 8-10 m), EBITDA-loss EUR 14-15 m (EUR 16-18 m), cash utilization EUR 20-22 m (EUR 23-27 m)

Martinsried/Munich, 5 December 2017. Medigene AG (MDG1, Frankfurt, Prime Standard, TecDAX) today announced the sale of the US-rights for its drug Veregen® to Fougera Pharmaceuticals, Inc., Melville, New York, USA, the dermatology business entity of Sandoz US, which is part of the Novartis group. Thereby, Medigene essentially monetizes the last remaining product from its previous pipeline before the company’s repositioning as an immunotherapy company with clinical programs in development.

Fougera, Medigene’s former partner for the distribution and marketing of Veregen® in the US, now acquires the US assets for the drug, including intellectual property, licenses, know-how and the trademark . Medigene remains the owner of the active pharmaceutical ingredient (API) stock for the product and becomes the exclusive supplier of the API to Fougera. The parties agreed on certain minimum purchase obligations, in order to ensure the successful continuation of the US business by Fougera. Furthermore, Fougera will reimburse Medigene for costs associated with the supply of API. Medigene retains all rights for Veregen® outside of the US. Veregen® is a topical treatment of genital warts.

Dr. Thomas Taapken, CFO of Medigene AG, comments: "Veregen® hasn’t been part of Medigene’s core business after refocusing on our immunotherapy R&D pipeline. With the sale of the US-rights for this product to our trusted commercialization partner, we are able to essentially complete Medigene’s corporate transformation into a pure-play, clinical-stage immuno-oncology company."

In the first nine months of 2017, Medigene’s Veregen® revenue from royalties, product sales and milestone payments from its distribution partners totaled 1.8 m EUR (9M-2016: 2.2 m EUR). In the past, on average over 50% of the annual Veregen® revenue was generated from the US business.

In connection with the sale of the US-rights for Veregen®, Medigene raises its financial guidance for 2017: Now, the company expects revenues of EUR 10.5-11.5 m instead of EUR 8-10 m as previously guided, an EBITDA-loss of EUR 14-15 m instead of EUR 16-18 m, and a cash utilization of EUR 20-22 m instead of EUR 23-27 m. This forecast does not include future milestone payments from the existing R&D partnership with bluebird bio or any payments from potential new transactions.

Besides, financial details of the agreement with Fougera were not disclosed.

About Veregen®: The drug, which is used to treat patients with external genital and perianal warts (Condylomata acuminata), is marketed in 22 countries by a range of distribution partners. More information on Veregen® can be found at http://www.medigene.com/pipeline/other-products/

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.