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Biofrontera AG reported preliminary first-quarter 2021 revenues of approximately EUR 5.6 million, a 14% decline from EUR 6.5 million in Q1 2020. US product sales dropped to EUR 3.9 million (down 6%), while Germany showed improvement with EUR 1.4 million (up 7%). However, sales in the rest of Europe fell to EUR 0.3 million, marking a decline of 69%. Notably, March 2021 sales in the USA surged 46% year-on-year, reflecting recovery likely due to high vaccination rates.
Biofrontera AG (NASDAQ: BFRA) will announce its 2020 fiscal year financial results on April 12, 2021. To discuss these results, shareholder conference calls are scheduled for April 13, 2021 in both German and English. The German call will start at 10:00 am CEST and the English call at 2:00 pm CEST. Investors can access the calls via specified dial-in numbers. This announcement marks a significant occasion as it includes the first financial reporting post-COVID-19 impact assessment for the company.
Biofrontera AG (NASDAQ: BFRA) has submitted a request to the FDA for approval of the BF-RhodoLED XL, a new red-light source designed for photodynamic therapy (PDT) alongside its product Ameluz®. This larger lamp will treat mild to moderate actinic keratoses, enabling treatment of multiple lesions simultaneously. The BF-RhodoLED XL's patent protection is expected to bolster Ameluz's market position in the U.S. The lamp features an advanced user interface, enhancing treatment customization, but is not planned for European markets at this time.
Biofrontera AG (NASDAQ: BFRA) has successfully completed a capital increase, raising approximately EUR 24.7 million through a rights offering to existing shareholders and a public offering of American Depositary Shares (ADS) in the U.S. The subscription price was set at EUR 2.75 per share, with ADS priced at USD 6.68 each. The funds will be utilized for clinical studies to enhance the market position of its lead product, Ameluz®, and to develop a new BF-RhodoLED® lamp, along with general corporate purposes. A total of 8,969,870 new ordinary shares will be issued.
Biofrontera AG (NASDAQ: BFRA) announced its FDA application to amend product information for Ameluz®, enabling the simultaneous use of three tubes for treating actinic keratoses. This follows a completed Phase I pharmacokinetics study that confirmed no differing safety profile compared to using one tube.
The study involved 32 patients and was conducted in Texas. Positive outcomes may enhance Ameluz®'s competitiveness in the dermatological market, expanding treatment capabilities for healthcare providers.
Biofrontera AG (NASDAQ: BFRA) has announced a public offering of 1,334,002 American Depositary Shares (ADSs) priced at $6.68 per ADS, intending to raise approximately $8.9 million. The offering is part of a concurrent rights offering for 8,969,870 ordinary shares at €2.75 per share, also aimed at enhancing financing for clinical studies to expand FDA-approved indications for its lead product, Ameluz®, and to develop the BF-RhodoLED® lamp. The offering is expected to close around February 26, 2021.
Biofrontera AG (NASDAQ: BFRA) announced that the German Federal Supreme Court overturned a prior ruling by the Cologne Higher Regional Court regarding the 2017 Annual General Meeting. This decision resulted from an annulment action by Deutsche Balaton AG against a discharge resolution for the Management Board. The Supreme Court found that the Management Board had not violated the duty of equal treatment of shareholders, countering the previous court's claims of misconduct related to a 2016 capital increase. The retrial will now occur to resolve the case further.
Biofrontera AG reports preliminary unaudited revenue for Q3 2020 ranging from EUR 20.8 to 21.0 million, a 9% increase from EUR 19.1 million in Q3 2019. However, Q3 2020 revenues are estimated at EUR 4.7 to 4.9 million, reflecting a 9% decrease compared to the same period last year. Product sales in the USA declined by approximately 19% to EUR 2.7 to 2.9 million, while sales in Germany surged by 36% to EUR 1.5 to 1.7 million. The company anticipates the fourth quarter to be a key revenue driver despite ongoing challenges due to the corona pandemic.
Biofrontera AG (NASDAQ: BFRA) has announced the completion of the clinical phase of its pharmacokinetics study for photodynamic therapy using three tubes of Ameluz simultaneously. Despite delays in patient recruitment due to the pandemic, the study included 32 patients and aims to expand Ameluz's use in treating actinic keratoses. Results on pharmacokinetics and safety are expected in Q4 2020, with a regulatory submission planned to the FDA by year-end to enhance its market competitiveness, especially in the US.
Biofrontera AG (NASDAQ: BFRA) announced that the German Federal Supreme Court has overturned a previous ruling from the Cologne Higher Regional Court regarding a legal dispute with Deutsche Balaton AG. The court's decision, made on September 22, 2020, revisits resolutions from the Company’s Annual General Meeting on May 24, 2017. This case, initially dismissed in 2017, was brought back for retrial after the Supreme Court granted Biofrontera's appeal.
