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PTA-News: Biofrontera AG: Governmental price decree for Ameluz® withdrawn in Spain

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Leverkusen (pta029/04.04.2022/14:35) - Biofrontera AG (ISIN: DE0006046113), an international biopharmaceutical company, announces that as of April 01, 2022, the drug price of Ameluz ® will no longer be reduced in Spain by what Biofrontera believes to be an incorrect price directive. A price cap was imposed on Biofrontera by the Spanish health authority in November 2020 by decree, forcing Biofrontera to reduce the original drug price of Ameluz ® in the Spanish market by 50%. The reduction came into effect due to what Biofrontera considered an incorrect classification of Ameluz ® in terms of the active ingredient concentration.

Biofrontera has defended itself against the authorities' classification in various ways over the past one and a half years. On the one hand, the company has directly complained with the authority and filed an objection. In addition, legal action was taken against this price decree and a lawsuit was filed against the authority's actions before a Spanish court.

Due to new regulations, the classification of active ingredients has now been revised so that the misclassification of Ameluz ® has been removed and Ameluz ® can now be sold again on the Spanish market for the original price of EUR 150. Biofrontera has subsequently withdrawn the legal claim. The outcome will have a positive impact on the international price stability of Ameluz ® throughout the EU.

"This agreement and the new assessment by the Spanish ministry are important steps for the further expansion of our European business," commented CFO Ludwig Lutter on the cancellation of the price decree. "We were able to partially compensate for this restriction in the market through our steadily growing market presence, however, revenue growth was difficult to achieve. Now we are confident that we will be able to continue on our growth path as in the years before Corona."


About Biofrontera:

Biofrontera AG is a biopharmaceutical company specializing in the development and sale of dermatological drugs and medical cosmetics. The Leverkusen-based company develops and markets innovative products for the treatment, protection and care of the skin. Its key products include Ameluz®, a prescription drug for the treatment of non-melanoma skin cancer and its precursors. Ameluz® has been marketed in the EU since 2012 and in the USA since May 2016. In Europe, the company also markets the Belixos® dermocosmetic series, a specialty care product for damaged skin. Biofrontera is one of a few German pharmaceutical company to receive a centralized European and a US approval for a drug developed in-house. The Biofrontera Group was founded in 1997 by Prof. Dr. Hermann Lübbert and is listed on the Frankfurt Stock Exchange (Prime Standard) and on US OTC market (BFAGY).

Forward-looking statements: Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "anticipate", "believe", "predict", "estimate" and "intend", among others. Such forward-looking statements are based on current estimates and assumptions made by Biofrontera AG's management to the best of its knowledge and belief, which in their opinion are reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, financial condition, performance or achievements of the company or industry to be materially different from any future results, financial condition, performance or achievements expressed or implied by such forward-looking statements. No undue reliance should be placed on such statements. Forward-looking statements speak only as of the date they are made, and the Company undertakes no obligation to update or revise any forward-looking statements.


emitter: Biofrontera AG
address: Hemmelrather Weg 201, 51377 Leverkusen
country: Germany
contact person: Investor Relations
phone: +49 (0) 214 87 63 20

ISIN(s): DE0006046113 (share)
stock exchanges: regulated market in Frankfurt, Dusseldorf; free market in Stuttgart, free market in Munich; open market in Berlin, Tradegate
other stock exchanges: Nasdaq

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