Biofrontera AG: Biofrontera Reports Full Year 2019 Financial Results
DGAP-News: Biofrontera AG
/ Key word(s): Annual Results
Biofrontera Reports Full Year 2019 Financial Results
Leverkusen, Germany, April 20, 2020 - 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, 2019 and provided an update on recent operational and clinical developments.
Full Year 2019 Financial Highlights:
2019 Operational and Clinical Development Highlights:
Recent Operational and Clinical Development Highlights:
"We have significantly advanced Biofrontera in 2019. Through the acquisition and integration of Cutanea Life Sciences, Inc. we were able to expand our market access in the USA. The improved reimbursement for treatment with Ameluz(R) in the USA and the growing acceptance of daylight PDT in Europe have led to an annual revenue growth of 48%. We recorded our highest quarterly sales in the fourth quarter, mainly driven by the strong demand for Ameluz(R) in the USA", commented Prof. Dr. Hermann Lübbert, CEO of Biofrontera AG. "In 2020 we will continue to intensify our educational work with dermatologists, so that even more patients will be offered our highly effective treatment option for actinic keratoses and, in the EU, also for basal cell carcinomas. With XepiTM we have a second highly innovative drug in our US portfolio. The fact that around 50% of the US population already receive unrestricted reimbursement for the treatment with XepiTM from their insurance companies shows how much the payors appreciate our new drug". Hermann Lübbert further explains: "The COVID-19 pandemic, however, has been affecting sales worldwide since March 2020. The reason for this is the decreasing number of medical treatments, especially treatments that are carried out in doctors' offices. Clinical studies are also affected by this. We have therefore implemented a number of cost-cutting measures that came into effect last month. As the situation is still very volatile, planning and predictability for revenue development remain very limited."
As it is currently impossible to foresee how long and how strongly the pandemic will affect the economy, no reliable estimate or more precise quantification of the specific implications for sales and earnings can be made for the 2020 financial year. For this reason, Biofrontera's ability to forecast is significantly impaired at this time. In its initial budget for the 2020 financial year, the Group had assumed a 25% increase in revenue compared to the previous year, and operating costs at approximately the same level as in the previous year. However, the effects of the coronavirus pandemic may lead to a significant deviation from previous projections and to a noticeable decline in sales compared to previous plans and possibly even compared to the previous fiscal year. The anticipated reduced revenue will also have a negative impact on the profitability of the Group and the liquidity of Biofrontera AG as well as the Group in the 2020 financial year, as the lack of revenue may not be fully offset by cost reduction measures. At the same time, the cost reduction measures already initiated and published on March 20, 2020 will continue. These measures include in particular the introduction of short-time work in Germany and comparable measures in Spain and the UK, the reduction of the workforce in the USA by almost 20% and mandatory unpaid leave for all employees in the USA. Steps to secure liquidity and strengthen cash flow are given high priority.
U.S. Commercial Update
In March 2019, Biofrontera acquired Cutanea Life Sciences, Inc., which expanded its product portfolio in the U.S. with the FDA-approved drug XepiTM, the first topical antibiotic to be approved since a decade. XepiTM is specifically also approved by the FDA for the treatment of infections with antibiotic-resistant bacterial strains such as MRSA. There are approximately 10 million prescriptions for topical antibiotics annually in the U.S., representing a significant growth opportunity for XepiTM as Biofrontera optimizes XepiTM reimbursement along with its marketing strategy.
In Germany, which remains the largest European market for Ameluz(R), Biofrontera's market share increased to 57% of PDT treatments compared to 52% in 2018. Ameluz(R) is thereby continuously established as the leader in the PDT market compared to competitive products. As daylight PDT - unlike conventional PDT - is reimbursed by the German public health care system, it allows Ameluz(R) to directly compete also with self-applied topical creams, which represent the majority of the actinic keratosis market in Europe.
In Spain, sales grew approximately 10%, more than compensating a major price decrease enforced by the Spanish government. In the United Kingdom, Biofrontera continues to focus on training hospital administrations to add Ameluz(R) as an approved drug in the respective hospital pharmacies. To date, the Company has seen success as some major hospitals now rate Ameluz(R) as the first choice PDT drug for the treatment of actinic keratosis and basal cell carcinoma. These successes are beginning to translate into steep sales growth; however, the UK still remains a minor portion of the Company's revenue. Shipments to license partners in other European countries declined significantly.
In the U.S. Biofrontera is working on various initiatives to expand the indication of Ameluz(R) and for continued development of sustained growth over the coming years. Biofrontera continues to enroll patients in its U.S. phase III study with Ameluz(R) for the treatment of superficial basal cell carcinoma (BCC). Due to slow recruitment, the Company expects to announce results from the study not before 2021.The approval of Ameluz(R) for superficial BCC would significantly expand the market opportunity for Ameluz(R) as it would be the only PDT-drug available in the United States for the treatment of this indication. Additionally, Biofrontera has initiated a pharmacokinetics (PK) study, as requested by the U.S. Food and Drug Administration (FDA), to examine the safety and efficacy of three tubes of Ameluz(R). The study is expected to be completed in the second half of 2020. In relation to using Ameluz(R) on larger body areas, Biofrontera is also developing a next generation "BF-RhodoLED(R) XL" lamp and currently expects to submit an application for approval to the FDA in the second half of 2020.
Biofrontera is also progressing with its research cooperation agreement with Maruho for the development of branded generics based on the Company's nanoemulsion technology. In addition, Biofrontera and Maruho have signed an exclusive license agreement to commercialize Ameluz(R) in East Asia and Oceania. Under the terms of the license and supply agreement, Maruho will obtain exclusive development and commercialization rights including the right to sublicense Ameluz(R) in East Asia and Oceania. Biofrontera will supply Ameluz(R) to Maruho at cost plus 25%. Maruho will make an upfront payment to Biofrontera AG in the amount of EUR 6 million plus additional future payments subject to achievement of certain regulatory and sales milestones. Maruho will also make royalty payments at an initial rate of 6% of net sales in the countries of its territory, which will increase depending on sales volume and will be reduced should generic products become available in the respective countries.
In German, April 21, 2020 at 10:00 am CEST (4:00 am EST)
In English, April 21, 2020 at 2:00 pm CEST (8:00 am EST)
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Biofrontera's annual report 2019 is available at https://www.biofrontera.com/en/investors/financial-reports.html.
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 the prescription medication XepiTM 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.
20.04.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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