Biofrontera AG

Biofrontera Reports Financial Results for Third Quarter and First Nine Months of 2017 - Seite 3

As Biofrontera further expands its selling and marketing activities, the Company has been focused on obtaining a streamlined reimbursement pathway. In November, the Company received notification from CMS (Centers for Medicare & Medicaid Services) that Ameluz® has been assigned a unique, product-specific billing code, or J-Code (J7345). The J-Code, which goes into effect in January 2018, provides reimbursement coding clarity for prescribing physicians in the U.S. Biofrontera anticipates that with this simplified reimbursement pathway as well as new CPT codes establishing improved reimbursement for photodynamic therapy, the Company will be able to further accelerate sales in 2018.

In October, Biofrontera further expanded the reach of Ameluz® in the U.S. with its inclusion in the U.S. Veterans Affairs Federal Supply Schedule (VA FSS). The VA FSS supports the healthcare requirements of the VA as well as other federal government agencies by providing federal customers with access to over 1 million state-of-the-art commercial products and services.

The Company met with the U.S. FDA to discuss the development pathway for the approval of Ameluz® for the treatment of BCC. The FDA agreed that the application of Ameluz® for superficial BCC could be based on a single additional phase III placebo-controlled pivotal trial to be conducted in the U.S., in which Ameluz® PDT will be compared to placebo PDT, which can be conducted with relatively few patients minimizing both time and expense

WW Regulatory and Commercial Update
In the third quarter of 2017, Biofrontera launched Ameluz® and BF-RhodoLED® in Israel with its partner Perrigo. Marketing approval for Ameluz® was granted in May 2016 for the treatment of actinic keratosis and the companies are now working with the Ministry of Health to expand the label to include BCC and field cancerization.

The quarterly statement including financial statements is available at
http://www.biofrontera.com/en/investors/financial-reports.

Conference calls for shareholders and interested investors will be held on 27 November 2017 at the following times:

10.00am CET (4.00am EDT) conference call in German:
Dial-in number: [phone]
Conference code: 57010235 #

2.00pm CET (8.00am EDT) conference call in English:
Dial-in number Germany: [phone]
Dial-in number UK: [phone]
Dial-in number USA: [phone]
Dial-in number USA (New York): [phone]
Conference code: 74490603 #

Enquiries, please contact:

Biofrontera AG