Shares of Leverkusen, Germany-headquartered Biofrontera AG (B8F.F) (BFRA) are currently down 5.61% on the Frankfurt Stock Exchange, trading at EUR 5.05.
Biofrontera is a revenue-generating biopharmaceutical company, operating in the medical space of photodynamic therapy for non-melanoma skin cancer and other dermatological conditions.
Photodynamic therapy, or PDT, is a treatment that uses a drug, called a photosensitizer or photosensitizing agent, and a particular type of light. When photosensitizers are exposed to a specific wavelength of light, they produce a form of oxygen that kills nearby cells.
The Company has two commercial prescription drugs – Ameluz gel, used in combination with the BF-RhodoLED lamp for photodynamic therapy treatment of actinic keratoses on the face and scalp, and Xepi, a topical antibiotic for treating impetigo.
Actinic keratoses, also known as solar keratoses, are rough patches of skin caused by damage from years of sun exposure. The rough scaly patches are mostly found on the face, lips, ears, back of hands, forearms, scalp or neck (Source: NHS). If left untreated, actinic keratoses have the potential to progress to squamous cell carcinoma, the second-most dangerous skin cancer after melanoma.
Impetigo is a contagious bacterial skin infection in children two to five years of age, characterized by blisters or sores on the face, neck, hands, and diaper area.
Ameluz gel was approved in the European Union in 2011 and in the U.S. in 2016. Xepi, which received FDA approval in December 2017, came under Biofrontera’s fold, following the acquisition of US-based Cutanea Life Sciences in March 2019.
The Company also markets Belixos dermatological range of cosmetics, which are available as a cream, gel and a scalp tonic. These products are based on an innovative formulation derived from traditional medicinal plant extracts, and are used for sensitive and inflamed skin to treat neurodermatitis, itching psoriasis, and rosacea. All Belixos products are available online through Amazon.
In the Pipeline:
Ameluz gel is also being explored in the indications of actinic keratoses (AK) on the extremities as well as the trunk and neck, basal cell carcinoma, squamous cell carcinoma in situ, and acne.
— The Company successfully completed its phase III trial of Ameluz and the BF-RhodoLED lamp for the treatment of actinic keratoses on the trunk and extremities in March of this year. The study met its primary endpoint, demonstrating that Ameluz was superior to placebo based on its mean total lesion clearance rate of 86 percent compared to 33 percent for placebo.
— A phase III study of Ameluz for the treatment of superficial basal cell carcinoma is underway in the U.S. Initiated in September 2018, this study is designed to enroll 186 patients at 12 study sites in the United States, with recruitment of patients expected to be completed in the first half of 2020, and FDA filing planned for the second half of 2020.
— A phase III study of Ameluz for the treatment of squamous cell carcinoma in situ in the U.S. and EU is under preparation. Squamous cell carcinoma in situ, often called Bowen’s disease, is a growth of cancerous cells that is confined to the outer layer of the skin. Although it is not a serious condition, very rarely, it can progress into an invasive skin cancer known as squamous cell carcinoma.
— A phase II study of Ameluz for the treatment of acne in the U.S. and EU is also being planned in collaboration with Biofrontera’s partner Maruho Co., Ltd, a Japanese pharmaceutical company. Maruho holds about 28.14 percent stake in Biofrontera.
The Company’s total revenue has increased over the years – specifically in the past three years, it has doubled.
Revenue, which was 6.1 million Euros in 2016, jumped to 12.0 million Euros in 2017 and further improved to 21.1 million Euros in 2018. Revenue was 13.9 million Euros in the first half of 2019 compared to 9.0 million Euros in the comparable year-ago period.
Looking ahead, the Company expects to break even this quarter (Q4) and report revenue in the range of 32.0 million Euros to 35.0 million Euros in the full year 2019.
Biofrontera commenced trading on the Frankfurt Stock Exchange, under the symbol “B8F” on October 3, 2006. B8F has traded in a range of 4.80 EUR to 8.13 EUR in the last 1 year.
The Company listed its American Depositary Shares on the NASDAQ, under ticker symbol “BFRA” on February 14, 2018. BFRA has traded in a range of US$11.04 to US$18.32 in the last 1 year.
Given the strong revenue growth and healthy balance sheet, and the Company working towards the label expansion of its lead drug Ameluz in various indications with high market potentials, Biofrontera is a stock worth watching.
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