Biofrontera AG: Biofrontera Reports Full Year 2018 Financial Results
DGAP-News: Biofrontera AG / Key word(s): Annual Results
Biofrontera Reports Full Year 2018 Financial Results
Leverkusen, Germany, April 29, 2019 - Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, today reported its financial results for the full year ended December 31, 2018 and provided an update on recent operational and clinical developments.
"2018 was a momentous year for Biofrontera that included a successful initial public offering on the Nasdaq as well as improved positioning and market potential for Ameluz(R) in the EU and U.S.
"As we look ahead, we expect to continue to expand our reach into the dermatologist offices by growing the market opportunity for Ameluz(R). We look forward to submit the applications for label extension in both the EU and U.S for actinic keratosis (AK) on the extremities, trunk and neck based on recent positive phase III trial results. The recent acquisition of Cutanea Life Sciences, Inc. added AKTIPAK(R) and Xepi(TM) to our product portfolio, enhancing our dermatology growth strategy by providing competitive treatment options to dermatologists. Finally, our partnership with Maruho to further develop a new branded generic towards clinical trials and a potential agreement for the development of Ameluz(R) for acne will augment our growth profile," concluded Dr. Lübbert.
Biofrontera's expectation is that the acquisition of Cutanea will not lead to any negative changes in operating activities, nor will it have any negative effects on Biofrontera's cash position for the full year 2019. Sales revenue from Aktipak(R) and Xepi(TM) are not included in the aforementioned guidance, and are expected to be in the mid-single digit million range. Additional marketing costs incurred in 2019 for the commercialization of the products acquired as part of the Cutanea transaction will be pre-financed by Maruho and will consequently not affect Biofrontera's net income in 2019.
Early 2019, Biofrontera also received approval by the U.S. Food and Drug Administration (FDA) to upscale the batch sizes for Ameluz(R) production. This five-fold increase in batch sizes secures the supply of Ameluz(R) as demand in the U.S. grows. Scaling the manufacturing process will also allow for a substantial improvement to the Company's gross margins.
Biofrontera recently announced that it has acquired all shares in Cutanea, a U.S. based specialty pharmaceutical company focused on dermatology. With this acquisition, Biofrontera expands its portfolio to include two additional prescription drugs, AKTIPAK(R) for the treatment of acne and Xepi(TM) for the treatment of Impetigo in the U.S. XepiTM has proven activity on, and FDA-approval for, drug resistant bacterial strains such as MRSA.
Following the acquisition of Cutanea, Biofrontera will use its expanded sales and marketing infrastructure in the dermatology space to successfully market all three drugs to dermatologists with its combined salesforce.
Furthermore, the Scottish Medicines Consortium (SMC) recommended Ameluz(R) for the treatment of superficial and nodular basal cell carcinoma allowing for full reimbursement within the National Health Service, the publicly funded national healthcare system in the United Kingdom. To leverage these new approvals and the improved reimbursement environment, Biofrontera launched a dedicated UK sales team in May 2018.
Biofrontera also recently announced positive results from its Phase III trial evaluating the safety and efficacy of conventional PDT with Ameluz(R) and BF-RhodoLED(R) for the treatment of AK on the extremities, trunk and neck. In line with the result for the primary endpoint of the study, which showed a mean lesion clearance rate per patient's side of 86% for Ameluz(R) compared to 33% for placebo, significant superiority of Ameluz(R) was demonstrated for all secondary endpoints investigated. Biofrontera expects to file for a label extension with the European Medicines Agency (EMA) and the FDA in the third quarter of 2019.
In March 2019, Biofrontera signed an agreement to continue a former research cooperation with Maruho for the development of branded generics. Biofrontera will investigate preclinical aspects of the nanoemulsion formulation of one of the four active ingredients tested in the initial project phase. In addition, Biofrontera and Maruho are in negotiations about a possible indication expansion of Ameluz(R) for acne. The parties are also discussing a license for Maruho to commercialize Ameluz(R) in Asia and Oceania. Maruho would initially assume all development costs for the acne indication expansion, part of which may be returned if license negotiations are not successful. Biofrontera would be responsible for carrying out the clinical studies required for approval in the U.S.
In German, at 10:00 am CET (4:00 am ET)
In English, at 2:30 pm CET (8:30 am ET)
The Company's full-year report including financial statements is available at
Biofrontera AG is a biopharmaceutical company specializing in the development and sale of dermatological drugs and medical cosmetics.
The Germany-based company, with almost 200 employees worldwide, develops and markets innovative products for the care, protection and treatment of the skin. The company's lead product is the combination of Ameluz(R), a topical prescription drug, and medical device BF-RhodoLED(R) for the photodynamic therapy of certain superficial skin cancers and their precursors. Ameluz(R) has been marketed in the EU since 2012 and in the United States since May 2016. In addition, the company markets AKTIPAK(R), a prescription medication for the treatment of acne, and Xepi(TM) for the treatment of impetigo in the United States. In the EU, the company also sells the dermocosmetics series Belixos(R), which offers specialized care for damaged or diseased skin.
Biofrontera is the first German founder-led 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 the current CEO Prof. Dr. Hermann Lübbert and is listed on the Frankfurt Stock Exchange (Prime Standard) and on the US NASDAQ.www.biofrontera.com.
29.04.2019 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
|Hemmelrather Weg 201|
|Phone:||+49 (0)214 87632 0|
|Fax:||+49 (0)214 87632 90|
|ISIN:||DE0006046113, NASDAQ: BFRA|
|Listed:||Regulated Market in Dusseldorf, Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Hamburg, Munich, Stuttgart, Tradegate Exchange; Nasdaq|
|EQS News ID:||804273|
|End of News||DGAP News Service|