Biofrontera AG

Biofrontera achieves strong U.S. sales performance of Ameluz® in first year of commercialization

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Leverkusen (pta012/18.10.2017/09:50) - * In one year of commercialization, Ameluz® achieved USUSD million in revenues representing fastest market uptake of a photodynamic therapy (PDT) drug launched in the U.S.
* Significant adoption of Ameluz® by 425 U.S. customers
* Ameluz® in the scientific focus at the Fall Clinical Dermatology Conference

Biofrontera AG (ISIN: DE0006046113), the specialist for the treatment of sun-induced skin cancer, today provided an update on the commercialization progress for its combination topical prescription drug Ameluz® and medical device BF-RhodoLED® for the photodynamic therapy (PDT) of actinic keratosis, a skin cancer precursor, in the United States. The combination product had been launched at last year's Fall Clinical Dermatology Conference. This year's conference, held from October 12-15 in Las Vegas, marks the first anniversary of Biofrontera's US commercialization.

In this first year of commercialization of Ameluz® in the United States, Biofrontera has successfully solidified its presence as a full service pharmaceutical organization. Absolutely crucial was the recruitment of highly qualified employees, such that by now a team of 45, including sales representatives, a medical liaison group, and a strong support and management team in our Wakefield, MA head office, covers 80% of the U.S.. The company supports physicians and patients with diverse customer service aspects, in particular for questions related to reimbursement. Ameluz® has already been adopted by 425 U.S. customers, generating sales of approximately USD5 million to date, or about USD200,000 per active sales representative. This success continues to demonstrate the clear demand for a highly efficacious treatment option for superficial skin cancers such as actinic keratosis.

During the last 12 months, the company has obtained all relevant state licenses for the commercialization of Ameluz® and BF-RhodoLED®, which allows for the sale of products without the use of third party wholesalers. As recently announced, the U.S. VA has further validated the treatment, signing a contract with Biofrontera and including the therapy on the VA Federal Supply Schedule. Additionally, the Company has established its own reimbursement support system to assist dermatologists with a temporary miscellaneous reimbursement code until the Company receives its specific J-code for Ameluz® in January 2018, which will significantly streamline the reimbursement process making Ameluz® an increasingly attractive option for dermatologists.