| Over a week ago | ||||
The company's… The company's preliminary unaudited revenue for the period January 1 to March 31, 2021 amounts to approximately EUR 5.6 million compared to EUR 6.5 million in the same period last year, a decline of 14%. Preliminary revenues from product sales in the US were around EUR 3.9 million, compared to EUR 4.2 million in Q1 2020, which corresponds to a decline of 6%. In Germany, revenues from product sales amounted to approximately EUR 1.4 million, compared to EUR 1.3 million in Q1 2020, a gain of 7%. In the rest of Europe, the company generated product sales of around EUR 0.3 million, compared to EUR 0.8 million in the same period last year, a decline of 69%. While sales in Germany remained relatively stable over the quarter compared to the previous year, revenues in the USA for the months of January and February 2021 were well below those of the previous year due to the pandemic. "Starting in the second half of March last year, our sales were significantly impacted by the pandemic, and this is where we already saw a significant upturn this year in the USA compared to last year. In March 2021, our sales in the USA increased by around 46% year-on-year, indicating a significant recovery of the situation in the USA, presumably also due to the high vaccination rates." | ||||
Biofrontera announced the… Biofrontera announced the submission for approval of a new, significantly larger red-light source for photodynamic therapy, or PDT, to be used in combination with Ameluz, the BF-RhodoLED XL, to the FDA. The new BF-RhodoLED(R) XL is to be approved in combination with Ameluz(R) for the treatment of mild and moderate actinic keratoses on the face and scalp. This corresponds to the current approval of Ameluz, with plans to broaden the label to include additional indications in the future. The new PDT lamp enables the treatment of larger areas as well as the simultaneous exposure of several actinic keratoses distant from each other. This regulatory filing is independent of the change in product information submitted to the FDA in February to allow the use of up to three tubes of Ameluz per treatment, but complements it in an effort to treat larger areas. Currently, the product information and thus reimbursement is limited to the use of one tube of Ameluz per treatment. Ahead of the submission to the FDA, the new lamp was protected by several patent applications, which, due to the specifics of the FDA's combination approval, will also protect Ameluz itself in the U.S. once the patents are granted. | ||||
| Over a month ago | ||||
Biofrontera announces the… Biofrontera announces the closing of the capital increase resolved by the annual general meeting on May 28, 2020. The capital increase was carried out by way of a subscription rights offering to existing shareholders of Biofrontera AG under German law. Unsubscribed shares were placed in the course of a public offering of American Depositary Shares in the United States. The Company raised total gross proceeds of approximately EUR 24.7 million. Net proceeds from these offerings will be used to conduct clinical studies aimed at improving the market positioning of Biofrontera's lead product Ameluz, in particular to seek FDA or other applicable regulatory approval for the extension of the indications in the United States to basal cell carcinoma, acne and actinic keratoses on body areas other than the face and scalp, as well as to complete the development of a larger BF-RhodoLED lamp, invest in the procurement of the necessary materials for it and to seek any FDA or other regulatory approvals required to launch the new lamp, as well as for general corporate purposes. | ||||
Biofrontera announces the… Biofrontera announces the submission of an application to the U.S. Food and Drug Administration to amend the product information to allow the simultaneous use of three tubes of Ameluz. The application is supported by a phase I pharmacokinetics study for the treatment of actinic keratoses with three tubes of Ameluz. In October 2020, the Company was able to complete the clinical phase of the PK study, which tested the safety of photodynamic therapy with the simultaneous use of three tubes of Ameluz on larger or multiple areas. Subsequently, the study data was analyzed, the study report was prepared and then incorporated into the regulatory dossier. The maximum use PK study included 32 patients with actinic keratoses on larger or multiple areas who received PDT treatment with a total of three tubes of Ameluz either on the face/scalp area or on the extremities/trunk/neck. Ameluz was applied in accordance with the currently licensed treatment protocol, except that three tubes of the drug were used to treat a skin area of 60 cm. Illumination was performed after 3 hours of occlusion, using either one or two BF-RhodoLED lamps simultaneously, depending on the number and location of the treatment area. The study was conducted at a specialized dermatological phase I facility in Texas/USA. The objective of the study was to evaluate the safety of patients after applying three tubes of Ameluz to the skin by investigating the amount of active ingredient that enters the blood stream. Further parameters related to the safety of patients undergoing such treatment were also investigated. Based on these results, the Company and the regulatory authority will be able to assess whether the simultaneous treatment with three tubes could lead to risks for patients. | ||||
Benchmark acted as lead… Benchmark acted as lead book running manager for the offering. | ||||
| Over a quarter ago | ||||
Biofrontera Pharma signed… Biofrontera Pharma signed an exclusive license and supply agreement for the marketing of both Ameluz and BF-RhodoLED in Sweden, Norway, Denmark, Finland and Iceland. According to the agreement, Galenica AB of Malmo, Sweden, receives exclusive distribution rights for the Nordic regions, whereby Biofrontera will supply Ameluz to Galenica at a transfer price of 50% of the expected net revenues. Furthermore, Biofrontera will be responsible for the marketing authorization as well as manufacturing and quality control, while Galenica will handle all aspects of commercialization, local registration and reimbursement in the Scandinavian countries. Both companies will collaborate on regulatory compliance regarding drug safety. After the amicable termination of the agreement between Biofrontera and the former distribution partner for some of these regions, Galenica is now working towards the reintroduction of the products in Denmark, Sweden and Norway and their initial launch in Finland and Iceland by the middle of next year. In addition, Galenica has a right of first refusal for commercialization in the Baltic States. | ||||
Biofrontera continues to… Biofrontera continues to be affected by the economic and social impact of the coronavirus pandemic. As a result, it remains difficult to accurately predict the company's business performance. However, as in previous years, the Company expects a significant increase in sales in the fourth quarter. | ||||
The company said,… The company said, "In October, the clinical phase of the pharmacokinetics study in the US, which has been ongoing since the beginning of the year, was completed. This study evaluated the safety of photodynamic therapy for the treatment of actinic keratoses on large or multiple surfaces using up to three tubes of Ameluz at a time. Despite delays in patient recruitment due to the coronavirus pandemic, the clinical phase of the study was completed in early October with the so-called "last subject last visit". The Company still expects to complete the final study report before the end of the year. The study is another important milestone to increase the competitiveness of Ameluz in the US. At the same time, the new BF-RhodoLED XL lamp is being completed, which enables the application of Ameluz(R) on larger areas. Due to delays in the supply of parts for the first manufacturing batch caused by the coronavirus crisis, the dossier for marketing approval will now be submitted to the FDA in the first quarter of 2021. Despite the difficult conditions, Biofrontera is working intensively to maintain all ongoing clinical studies and to meet the communicated timelines as far as possible. The already slow patient recruitment of the Phase III study of Ameluz(R) in the US for the treatment of basal cell carcinoma also continues as planned." | ||||
"The coronavirus… "The coronavirus pandemic continues to be a tremendous challenge for us all. Following a 30% decline in product sales in the first half of the year when compared to the same period in 2019, the decline for the first nine months of 2020 has narrowed to just 23%. The closing of the revenue gap is mainly due to the crisis in the USA, whose gradual easing is reflected in the sales figures. The overall decrease in US-revenues was compensated by the strong sales performance in Germany and the one-time payment made by Maruho Co., Ltd., so that an overall 9% increase in sales was achieved compared to the same period last year" commented CEO Prof. Dr. Hermann Lubbert. "In the third quarter, we saw sales stabilize to a great extent in line with the usual seasonality. Even against the background of the ongoing pandemic, we are therefore optimistic about the fourth quarter. Due to the implementation of our global cost-saving measures since March, we managed to keep Q3 operating costs during the coronavirus crisis well below the previous year's level. As a result, our operating result was considerably better than in Q3 2019 despite the 9% drop in quarterly sales." | ||||
Biofrontera announced… Biofrontera announced previously on September 22, that in a ruling, the German Federal Supreme Court has overturned a decision by the Cologne Higher Regional Court dated November 15, 2018, which was directed against the company. The case was referred back to the Cologne Higher Regional Court for retrial and decision. Biofrontera AG has now received the statement of reasons of the German Federal Supreme Court regarding the reversal of the ruling by the Cologne Higher Regional Court. The Cologne Higher Regional Court, following an action for annulment and rescission by a shareholder, Deutsche Balaton AG, had annulled the resolution of the Annual General Meeting held on May 24, 2017, which granted discharge to the management board of Biofrontera for FY16. In its reasons for the decision, the Cologne Higher Regional Court assumed that the management board had violated the requirement of equal treatment of shareholders in connection with a capital increase carried out in October/November 2016 in a severe and unequivocal manner. The German Federal Supreme Court has now determined that the violation of law assumed by the Cologne Higher Regional Court has not occurred. While the ruling of the Cologne Higher Regional Court had not become legally binding, the reasoning for the ruling, the alleged significant violation of the duties of the management board, was repeatedly publicly communicated or quoted by interested parties. According to the ruling of the German Federal Supreme Court, however, the nullification of the discharge resolution could not be based on the grounds given by the Cologne Higher Regional Court. Furthermore, the annual general meeting held on May 24, 2017, had resolved to create new authorized capital. The Cologne Higher Regional Court had also declared this resolution null and void, since the annual general shareholders' meeting had allegedly acted in bad faith towards the plaintiff when passing the resolution. This reasoning also failed to pass the review by the German Federal Supreme Court. | ||||