Biofrontera AG
Ansprechpartner: Investor & public relations
Tel.: +49 (0) 214 87 63 20


03.10.2023 - 21:30 | Talenthouse AG
03.10.2023 - 18:35 | heygold SE
03.10.2023 - 18:05 | Trade & Value AG
Business news for the stock market

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

Leverkusen (pta/18.10.2017/09:50 UTC+2) * 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.

"We have spent the last year working diligently to ensure the successful commercialization of Ameluz®, including participation in more than 40 dermatology congresses and scientific meetings, regionally and nationally, to directly educate and engage with dermatologists to drive adoption of Ameluz®. This past week, we attended the Fall Clinical Dermatology Conference to further our relationships with physicians in the field," commented Christoph Dünwald, CCO of Biofrontera. "As we move forward, we anticipate the ability to increase our market share with Ameluz®, as well as expand the treatment indications as PDT receives more favorable reimbursement."

Enquiries, please contact:

Biofrontera AG
Thomas Schaffer, Chief Financial Officer
+49 (0) 214 87 63 2 0

IR Germany: Brainwell Asset Solutions
Jürgen Benker
+49 (0) 152 08931514

IR UK: Seton Services
Toni Vallen
+44(0) 20 7729 0805

IR and PR US: The Ruth Group
IR: Tram Bui
+1 646-536-7035
PR: Kirsten Thomas
+1 508-280-6592

About Biofrontera:
Biofrontera AG is a biopharmaceutical company specializing in the development, sale and distribution of dermatological drugs and medical cosmetics. The Leverkusen, Germany-based company, which has approximately 130 employees worldwide, develops and distributes innovative products for the care, protection and treatment of the skin. Biofrontera's combination lead product is topical prescription drug Ameluz® and medical device BF-RhodoLED® for the photodynamic therapy (PDT) treatment of superficial skin cancer and its precursors. Ameluz® has been marketed in the EU since 2012 and in the U.S. since 2016. The Company also markets the Belixos® dermocosmetics series in the EU, which offers specialized care for damaged or diseased skin.

Biofrontera is the first German, founder-led pharmaceutical company to obtain both EU and U.S. approval for a medical drug it has developed itself. The Biofrontera Group was established in 1997 by current CEO, Prof. Dr. Hermann Lübbert, and is listed on the Frankfurt Stock Exchange (Prime Standard).

This communication expressly or implicitly contains certain forward-looking statements concerning the business activities of Biofrontera AG. These forward-looking statements reflect the opinion of Biofrontera at the time of this communication and involve certain known and unknown risks. The actual results achieved by Biofrontera may differ significantly from future results or performances which are published in its forward-looking statements. Biofrontera assumes no responsibility to update its forward-looking statements.


Emitter: Biofrontera AG
Hemmelrather Weg 201
51377 Leverkusen
Contact Person: Investor & public relations
Phone: +49 (0) 214 87 63 20
ISIN(s): DE0006046113 (Share)
Stock Exchange(s): Regulated Market in Dusseldorf, Frankfurt; Free Market in Berlin, Munich, Stuttgart, Tradegate