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Biofrontera AG announced the decision to delist its American Depositary Shares (ADS) from the Nasdaq Capital Market due to the aim of reducing financial reporting complexities and administrative costs. The company plans to maintain a Level I ADS program, enabling continued trading on the U.S. OTC market. Current ADS holders can exchange their shares for ordinary shares listed on the Deutsche Börse. The company expects to submit a Form 25 to the SEC by February 24, 2022, with delisting effective approximately ten days thereafter.
Biofrontera AG (NASDAQ: BFRA) is engaged in mediation to settle legal disputes with major shareholder Mr. Wilhelm K. T. Zours and Deutsche Balaton AG. This mediation has led to a consensus on candidates for the Supervisory Board to be proposed at the Annual General Meeting on December 14, 2021. The agreement will terminate existing lawsuits, enabling the company to potentially raise future capital. The candidates include Dr. Heikki Lanckriet, Dr. Helge Lubenow, Prof. Franca Ruhwedel, Karlheinz Schmelig, Dr. Jörgen Tielmann, and Mr. Zours as Chair. Maruho Deutschland GmbH supports these nominations.
Biofrontera AG (NASDAQ: BFRA) reported financial results for the nine months ending September 30, 2021, showing a 11% decline in total revenue to EUR 18.5 million, vs. EUR 20.8 million in 2020. This drop was largely due to a one-time licensing payment in the previous year. However, product sales surged by 29% year-over-year to EUR 18.5 million with significant growth in the U.S. market, increasing by 36% to EUR 12.3 million. The company maintains its guidance for 2021, expecting revenues of EUR 25-32 million and an EBITDA loss of EUR 11-14 million.
Biofrontera AG (NASDAQ: BFRA) announces the initiation of two clinical studies in the U.S. for its drug Ameluz®. The phase II study targets moderate to severe acne, while the phase I study assesses safety in photodynamic therapy (PDT). The phase II study involves 126 patients, with a focus on changes in inflammatory lesions. The phase I study includes 100 patients and aims to evaluate the safety of using three tubes of Ameluz® per treatment. Both studies aim to enhance market positioning for Ameluz®, currently FDA-approved for actinic keratoses.
Biofrontera AG (NASDAQ: BFRA) will announce its financial results for the first nine months ending September 30, 2021, on November 17, 2021. Following this, there will be conference calls for shareholders on November 18, 2021, in German at 10:00 am CET and in English at 2:00 pm CET. The calls can be accessed via designated dial-in numbers. Biofrontera specializes in dermatological drugs, notably the combination of Ameluz and BF-RhodoLED for treating superficial skin cancers, with a presence in the EU and US markets since 2012 and 2016, respectively.
Biofrontera AG (NASDAQ: BFRA) has received FDA approval for its new photodynamic therapy device, the BF-RhodoLED® XL, intended for treating actinic keratoses on the face and scalp. This device, used in conjunction with the prescription drug Ameluz®, allows for larger treatment areas and simultaneous management of multiple conditions. The approval also secures patent protections that enhance Ameluz®'s market position in the U.S.
Manufacturing of the new lamp adheres to class III medical device standards but will not be marketed in Europe.
Biofrontera AG (NASDAQ: BFRA) reported preliminary unaudited revenue for September 2021, with product sales ranging from EUR 2.3 to 2.5 million, marking a 33% increase from EUR 1.8 million in September 2020. Revenue in the US rose by 64% to between EUR 1.6 and 1.8 million, while sales in Germany declined by 19% to EUR 0.4 to 0.6 million. Year-to-date product sales showed an 11% increase compared to September 2019, with US sales down 9% compared to the same period in 2019, attributed to early pandemic impacts.
Biofrontera AG (NASDAQ: BFRA) reported preliminary revenue for August 2021 totaling approximately EUR 1,485 thousand, marking an 11% increase from EUR 1,341 thousand in August 2020. The US sales contributed around EUR 1,027 thousand (up 12%), while Germany saw a modest rise to EUR 349 thousand (up 1%). The rest of Europe experienced a significant increase of 38%, reaching EUR 109 thousand. Year-to-date product sales rose by 25% in Germany and 21% in other European markets compared to 2019, although US sales fell by 12% due to earlier pandemic-related weaknesses.
Biofrontera AG (NASDAQ: BFRA) announced its financial results for the six months ending June 30, 2021, reporting revenues of EUR 13,094 thousand, down 19% from EUR 16,117 thousand in 2020. This decline was attributed to a one-time payment in the prior year. Notably, product sales increased by 35% to EUR 13,094 thousand. The company's cash and equivalents rose to EUR 32,632 thousand. Biofrontera retains its guidance for 2021, expecting revenues between EUR 25 and 32 million despite potential changes due to the upcoming IPO of Biofrontera Inc.
Biofrontera AG (NASDAQ: BFRA) will announce its financial results for the first half of 2021 on August 19, 2021. A conference call for shareholders and investors will take place on August 20, 2021, with sessions in German at 10:00 am CEST and in English at 2:00 pm CEST. Dial-in details are provided for both sessions. Biofrontera specializes in dermatological drugs, including Ameluz®, which treats skin cancers, and Xepi®, which is for impetigo. The company is notable for being the first German founder-led pharmaceutical company to achieve centralized approvals in Europe and the US.
