お知らせ • Jul 23
Biofrontera AG, Annual General Meeting, Aug 28, 2024 Biofrontera AG, Annual General Meeting, Aug 28, 2024, at 10:00 W. Europe Standard Time. お知らせ • May 16
Biofrontera AG to Report Q1, 2024 Results on May 31, 2024 Biofrontera AG announced that they will report Q1, 2024 results on May 31, 2024 お知らせ • Apr 24
Biofrontera AG to Report Fiscal Year 2023 Results on Apr 30, 2024 Biofrontera AG announced that they will report fiscal year 2023 results at 12:00 PM, Central European Standard Time on Apr 30, 2024 お知らせ • Nov 07
Biofrontera AG to Report Q3, 2023 Results on Nov 28, 2023 Biofrontera AG announced that they will report Q3, 2023 results on Nov 28, 2023 お知らせ • Jul 14
Biofrontera AG to Report First Half, 2023 Results on Aug 31, 2023 Biofrontera AG announced that they will report first half, 2023 results on Aug 31, 2023 お知らせ • Jul 06
Biofrontera Launches Novel Belixos Active Care Biofrontera announced that the active cosmetic series belixos has been extended by the care foam belixos ACTIVE CARE. belixos ACTIVE CARE is a skin-so clothing care foam for irritated and itchy skin that can be used as basic care for atopic dermatitis and psoriasis, as well as for soothing intensive care for everyday skin problems. With its innovative formulation as a foam, it provides a pleasant feeling on the skin without a greasy film and enables particularly gentle application of the high-quality ingredients as a result of the reduced foam formulation. Due to it's innovative nature, Biofrontera was able to register the underlying innovative foam formulation as a patent. As previously in the belixos cosmetics series, the focus is on the traditional medicinal plant Mahonia as an active component. The medicinal plant, which is still quite unknown in European country but has been used for centuries in the medicine of the indigenous people of North America, is known to have anti-inflammatory, antipruritic and antiseptic properties. With the help of Biofrontera's proprietary biocolloid technology, the plant-based active ingredients penetrate very quickly into the epidermis and distribute there in order to unfold their soothing and regenerating effect in this very sensitive layer of skin that is particularly accessible to external influences. お知らせ • May 30
Biofrontera AG to Report Q1, 2023 Results on May 31, 2023 Biofrontera AG announced that they will report Q1, 2023 results on May 31, 2023 お知らせ • May 18
Biofrontera AG Completes Patient Recruitment of Ameluz Phase I Trial Biofrontera AG announced the successful completion of the Phase I study evaluating the safety and tolerability of Ameluz-PDT for the treatment of actinic keratosis (AK) with 3 tubes of Ameluz. This trial was conducted to expand the approval of Ameluz in the United States so that larger areas of AK-affected skin can be treated in one therapy session. The study involved 100 patients with mild to severe actinic keratosis, each of them receiving the contents of 3 tubes of Ameluz for a field-directed treatment of AK. Illumination was provided by Biofrontera's novel, larger RhodoLED XL lamp. The first results of the study are expected in the fourth quarter of 2023. お知らせ • May 13
Biofrontera AG, Annual General Meeting, Jun 20, 2023 Biofrontera AG, Annual General Meeting, Jun 20, 2023, at 11:30 Central European Standard Time. Location: Forum Leverkusen, Agam-Saal, Am Büchelter Hof 9, Leverkusen Germany お知らせ • Dec 09
Biofrontera AG Announces Executive Appointments to Biofrontera UK Ltd Biofrontera AG announced that it has established a subsidiary to continue the commercialization of Ameluz® in the United Kingdom. The newly founded Biofrontera UK Ltd. Is based in Cambridge, UK and headed by Ms. Pilar de la Huerta and Dr. Montserrat Foguet as Managing Directors. お知らせ • Nov 24
Biofrontera AG Continues to Adhere to Its Forecast for Fiscal Year 2022 Biofrontera AG continued to adhere to its forecast for fiscal year 2022. Thus, the Group expects sales of EUR 24 to 27 million and positive EBITDA in 2022, provided that the encouraging business performance of the first nine months will continue. お知らせ • Sep 21
Biofrontera AD Shares - Sponsored to Be Deleted from OTC Equity Biofrontera AG American Depositary Shares - Sponsored will be deleted from OTC Equity effective from September 21, 2022, due to ADR /GDR Program Terminated. お知らせ • Aug 26
Biofrontera AG Appoints Prof. Dr. Karin Lergenmüller to the Supervisory Board Biofrontera AG announces the election of Prof. Dr. Karin Lergenmüller to the Supervisory Board at the Annual General Meeting on August 23, 2022. The attending shareholders represented approximately 46% of the registered share capital. Following Prof. Dr. Ruhwendel's resignation from the Supervisory Board in February 2022, a sixth position on the Supervisory Board of Biofrontera AG was temporarily vacant. The management submitted a proposed resolution to Annual General Meeting to downsize the Supervisory Board to five members, which was, however, rejected by the shareholders. The appointment of Prof. Lergenmüller to the Supervisory Board of Biofrontera AG, as proposed by Deutsche Balaton AG by way of a supplementary motion, was approved by a majority of 73.6% of the share capital permitted to be represented at the Annual General Meeting. Prof. Lergenmüller worked for Deutsche Bank AG after holding positions in the management consulting industry, including at Andersen Consulting and Gemini Consulting. From 1996 to 1998 she was a member of the management of Joas & Comp., Bad Homburg. Since 1999, Prof. Dr. Karin Lergenmüller has been Professor of Marketing and General Business Administration at the Rhine-Main University of Applied Sciences, Wiesbaden. Since 2000 Prof. Dr. Karin Lergenmüller is Global Equity Investor, specialized in Digital World, Technology companies, NFT's and Crypto. Furthermore, Prof. Lergenmüller holds various supervisory board mandates in companies of the Deutsche Balaton Group. お知らせ • Jun 10
Biofrontera AG Appoints Paul Böckmann to Management Board The Supervisory Board of Biofrontera AG appointed Paul Böckmann to the company's Executive Board, initially for a limited time until August 31, 2022. Mr. Böckmann will support the current sole member of the Executive Board, Ludwig Lutter, as interims manager. Paul Böckmann is an independent management consultant and coach specializing in particular in global commercialization strategies, international business expansion and complex international reorganizations. He has worked for various pharmaceutical companies, including CSL Behring AG and Sanochemia, and has specialized in the international commercialization of plasma derivatives since 2016. Since 2021, he has been advising internationally operating plasma companies on product commercialization and reorganization of their business activities with his own consulting company. In particular, he is to be involved in the above-mentioned dialogues between Biofrontera AG and Biofrontera Inc. to develop appropriate solutions for this process. お知らせ • May 13
Biofrontera AG to Report Q1, 2022 Results on May 17, 2022 Biofrontera AG announced that they will report Q1, 2022 results on May 17, 2022 お知らせ • May 02
Biofrontera AG Provides Earnings Guidance for the Year 2022 Biofrontera AG provided earnings guidance for the year 2022. The Management Board stated therein that with the expectation of a further recovery of the most important sales markets from the pandemic consequences, the company should achieve sales between EUR 24 and 27 million for the 2022 financial year following the realignment of the company through the independence of Biofrontera Inc. and deconsolidation. The company is expected to achieve approximately break-even EBITDA and a negative EBIT in the low single-digit million range in 2022. お知らせ • Apr 14
Biofrontera AG to Report Fiscal Year 2021 Results on Apr 28, 2022 Biofrontera AG announced that they will report fiscal year 2021 results on Apr 28, 2022 お知らせ • Apr 09
Biofrontera AG Proposes Revenue Guidance for the Year 2022 Biofrontera AG proposed revenue guidance for the year 2022. For the year, the company expects total revenues are expected to increase by at least 30% compared with 2021, including first quarter total revenues up by over 100% versus the first quarter prior year and typical seasonal strength in the first and fourth quarters. お知らせ • Feb 24
Biofrontera AG Resigns Franca Ruhwedel as Member of the Supervisory Board Biofrontera AG announced that Prof. Dr. Franca Ruhwedel resigned from her position as a member of the supervisory board with immediate effect for good cause. お知らせ • Feb 15
Biofrontera AG Decides to Delist ADS from Nasdaq Biofrontera AG decided on February 14, 2022 its American Depositary Shares (“ADS”) should be delisted from the Nasdaq Capital Market (“Nasdaq”) and its reporting obligations with the Securities and Exchange Commission (“SEC”) should be deregistered and terminated. The main purpose of the delisting is to reduce complexity in financial reporting and administrative costs. Biofrontera AG intends to maintain an amended ADS program on a Level I basis, which will allow investors to continue to hold their securities in the form of ADSs and trade the ADS on the U.S. over-the-counter (OTC) market. The ADSs will automatically transition to the new ADS program in connection with the delisting and will be traded under a new ticker to be designated. Biofrontera AG’s ordinary shares will continue to trade in the Prime Standard at the Deutsche Börse under the symbol B8F. Holders of ADSs may choose to exchange their ADSs to holding ordinary shares listed on the Deutsche Börse. Further details regarding the procedures will be announced later. The Company plans to submit a Form 25 relating to its ADSs on Nasdaq to the SEC on or about February 24, 2022 to initiate the delisting and expects the delisting to be become effective not less than ten days later. お知らせ • Feb 02
Biofrontera AG Announces Progress of Phase Iii Study for the Treatment of sBCC with Ameluz® Biofrontera AG is making progress in patient recruitment of its US phase III clinical study to investigate the treatment of superficial basal cell carcinoma with photodynamic therapy using Ameluz® in combination with BF-RhodoLED® (together, Ameluz®-PDT). To date, 70% of the planned 186 patients have been enrolled in the study with completion of patient recruitment anticipated by the end of 2022. Patient recruitment for this study has been ongoing since September 2018. Due to the demanding study protocol mandated by the FDA, patient recruitment has been slower than anticipated and was additionally decelerated by the pandemic. However, patient recruitment has recently picked up again. Following successful FDA approval, Ameluz® would be the only drug in the United States for the treatment of sBCC with PDT. As a reminder, Ameluz®-PDT is approved in the European Union for the treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment since January 2017. お知らせ • Dec 14
Biofrontera AG Enrolls First Patient to Phase IIb Clinical Study Evaluating Ameluz® / BF-RhodoLED® for Acne Biofrontera Inc. announced that the first subject has been enrolled in the Phase 2b study performed by Biofrontera Bioscience GmbH to evaluate the safety and efficacy of Ameluz® in combination with the red-light lamp BF-RhodoLED® for the treatment of moderate-to-severe acne with photodynamic therapy (Ameluz®-PDT). The multicenter, randomized, double blind phase II study with four arms uses conventional Ameluz®-PDT and includes 126 adult patients suffering from moderate to severe acne, which will be treated with Ameluz®-PDT or placebo. The efficacy of Ameluz®-PDT will be tested with respect to incubation periods of one and three hours compared to placebo. The composite primary endpoint of the study is the absolute change in the number of inflammatory lesions and an improvement in symptoms. To ensure data consistency across all participating sites, the study will combine clinical assessments performed by the investigators conducting the study with a cutting-edge, FDA-approved, artificial intelligence analysis platform that will provide an automated lesion count along with a severity assessment. A total of seven sites are participating in the study. お知らせ • Aug 20
Biofrontera AG Re-Affirms Earnings Guidance for the Year 2021 Biofrontera AG re-affirmed earnings guidance for the year 2021. The Management Board therefore maintains its guidance for fiscal year 2021 published on April 12, 2021 in its
entirety. Accordingly, the Management Board expects annual revenues between EUR 25 and 32 million as well as EBITDA loss between EUR 11 and 14 million and EBIT loss between EUR 13 and 16 million. お知らせ • Jun 23
Biofrontera AG Provides Update on Clinical Developments Biofrontera AG provided an update on its clinical developments. In February and March 2021, the Company announced two submissions to the U.S. Food and Drug Administration (FDA), enabling the simultaneous use of up to three tubes of Ameluz® per photodynamic therapy (PDT) on the one hand, while seeking approval for a larger red-light lamp, the BF-RhodoLED® XL, on the other. In June 2021, the meeting with the FDA previously announced for both submissions took place, in which the further proceeding was determined. With regard to the approval process of BF-RhodoLED®, the FDA has confirmed that the data are sufficient for the submission and that the evaluation process will be initiated. The other submission, the application for amendment of the product information to extend the posology allowing the simultaneous use of three tubes of Ameluz®, was discussed intensively in talks with the FDA. The regulatory agency did not express any concerns related to efficacy or to the results from the phase I pharmacokinetics study underlying the application. However, to amend the product information, which currently limits the use to one tube of Ameluz® per treatment, the FDA recommended the submission of expanded safety data. The FDA agreed with the proposal to observe systemic and local side effects during treatment with three tubes of Ameluz® in 100 patients. This safety study is scheduled to start in the second half of 2021. With regard to the potential expansion of the Ameluz® approval to moderate and severe acne in the USA, the Company has finalized the design of the phase IIb trial, taking into account the regulatory recommendations agreed upon with the FDA in 2020. A multicenter, randomized, double-blind study with four arms is planned for conventional PDT with Ameluz® involving 126 patients aged 16 years and older. Ameluz® incubation times of one and three hours will be compared with placebo. The aim of the study is to collect data on the efficacy and safety when using Ameluz® PDT for moderate and severe acne. As previously announced, the trial is scheduled to start in the second half of 2021. Comparable to the European approval expansion of Ameluz® for the treatment of mild and moderate actinic keratoses (AK) on the extremities and trunk/neck with PDT, the Company is currently preparing phase III trials for this approval expansion in the USA. Patient recruitment is expected to start in the first half of 2022. Also scheduled to begin in the second half of 2021 in the USA is a study evaluating an illumination protocol for which Biofrontera has filed a patent application. The goal of the study is to reduce pain during illumination in conventional PDT for actinic keratoses on the face and scalp. Patient recruitment has picked up again for the clinical trial for the treatment of superficial basal cell carcinoma (BCC) with Ameluz® in conjunction with the BF-RhodoLED® lamp in the USA. To date, approximately 60% of the planned 186 patients have been enrolled in the study. Due to the demanding study protocol, the recruitment process has been very lengthy and was heavily influenced by the pandemic last year. お知らせ • Apr 13
Biofrontera AG Provides Earnings Guidance for the Year 2021 Biofrontera AG provided earnings guidance for the year 2021. The Group expects revenue from product sales of EUR 25 million to EUR 32 million in fiscal year 2021. EBITDA and EBIT will be introduced as key performance indicators in reporting starting in 2021. Both have become established internationally as target metrics and will replace the previously reported key performance indicator result from operating activities. Based on the above assumptions, the Biofrontera Group expects LBIT between EUR 13 million and EUR 16 million in 2021. お知らせ • Mar 05
Biofrontera AG to Report Fiscal Year 2020 Final Results on Apr 12, 2021 Biofrontera AG announced that they will report fiscal year 2020 final results on Apr 12, 2021 お知らせ • Feb 03
Biofrontera AG Announces Management Changes The Supervisory Board of Biofrontera AG announced a change in the company’s Management Board. Effective March 1, 2021, Mr. Ludwig Lutter has been appointed as the new Chief Financial Officer (CFO) of Biofrontera AG. He succeeds Thomas Schaffer and will be responsible for Finance, Administration, Controlling and Human Resources within the company. Thomas Schaffer will be leaving the Company by best mutual consent on February 28, 2021, to pursue new personal commitments outside the Company. This change is part of the succession planning previously announced by the Supervisory Board and the Management Board. Thomas Schaffer was appointed CFO in June 2013 and has since successfully accompanied Biofrontera AG on its way to becoming a leading specialty pharma company. By replacing his position as planned, the Supervisory Board, together with the Management Board, has now been able to set the course for a smooth transition of the Management Board within the framework of the intended succession planning at an early stage. Ludwig Lutter has over 20 years of experience as CFO in numerous technology companies. Before joining Biofrontera, he served as CFO for brillen.de, Hotel Reservation Service, Intershop Communications AG, SOPHOS und Poet Holdings Inc., which under his responsibility was brought public on both Nasdaq and the Frankfurt Stock Market, among other start-ups and IT-companies. Prior to that, he served in public accounting and tax consulting for KPMG and other public accounting firms. お知らせ • Oct 15
Biofrontera AG Receives Reasons from the German Federal Court of Justice for Overturning Ruling of the Cologne Higher Regional Court Biofrontera AG announced on September 22, 2020, that in a ruling from September 22, 2020, 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 AG for fiscal year 2016. 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 (e.g. in countermotions to annual general meetings or at annual general meetings themselves). 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. お知らせ • Oct 10
Biofrontera AG Reports Completion of the Clinical Phase of the Pharmacokinetics Study Biofrontera AG reported the completion of the clinical phase of the pharmacokinetics study to test the safety of photodynamic therapy using three tubes of Ameluz at the same time. The maximal use PK study included a total of 32 patients with extended fields of actinic keratosis who received one PDT treatment with a total of three tubes of Ameluz either on the face/scalp, or on extremities/trunk/neck. Ameluz was applied in accordance with the currently licensed protocol, except that three tubes of the drug were used to cover a total skin area of 60 cm², which could be either in one continuous or two separate fields. Illumination was performed after 3 hours of occlusion, using either one or two BF-RhodoLED lamps, depending on number and localization of the treatment area(s). The study was carried out in one specialized dermatological phase I unit in Texas/USA. The primary endpoint of the study is to obtain pharmacokinetics profiles in the subjects’ blood when three tubes of Ameluz are applied. The assessment of systemic bioavailability of drugs and metabolites that are applied to the skin and intended for local action at the application site is mandatory within the framework of US Food and Drug Administration regulations. In addition, safety and tolerability of Ameluz PDT with three tubes are assessed under maximal use conditions as a further important endpoint. These data aid to understand the safety profile and to describe treatment related side effects, such as local skin reactions on both face/scalp and extremities/trunk/neck. Following the completion of the clinical phase, Biofrontera expects to receive the results on both pharmacokinetics and safety during fourth quarter 2020. The Company aims at a regulatory submission to expand the existing license to include the use of up to three tubes of Ameluz for the lesion-directed and field-directed treatment of mild to moderate actinic keratoses on the face and scalp in combination with the BF-RhodoLED lamp. お知らせ • Sep 23
Biofrontera AG Announces German Federal Supreme Court Overturns Ruling of the Cologne Higher Regional Court Biofrontera AG announced that in ruling on September 22, 2020, the German Federal Supreme Court overturned a decision by the Cologne Higher Regional Court dated November 15, 2018, which was directed against the Company. The overturned ruling of the Cologne Higher Regional Court concerned an action for rescission and annulment brought by the shareholder Deutsche Balaton AG against certain resolutions of the Annual General Meeting held on May 24, 2017. The matter has now been referred back to the Cologne Higher Regional Court for retrial and decision. The reasons for the ruling of the Federal Supreme Court are currently not available to the Company. Context and chronology of the legal dispute as published on August 26, 2020 in Biofrontera's interim financial report 2020: In June 2017, Biofrontera AG was served with a claim by the shareholder Deutsche Balaton AG, aimed at rescission and nullification of certain resolutions of the Annual General Meeting held on May 24, 2017. The lawsuit was dismissed by the Cologne Regional Court in December 2017. On appeal by Deutsche Balaton AG, the Cologne Higher Regional Court granted the action in November 2018. In its ruling, the Cologne Higher Regional Court did not allow a review of the judgment by the Federal Supreme Court. Since the company considered the judgment of the Cologne Higher Regional Court to be incorrect, it filed a non-admission appeal at the Federal Supreme Court, which was granted in May 2020. In its ruling of September 22, 2020, the German Federal Supreme Court overturned the decision of the Cologne Higher Regional Court and referred the case back to the Cologne Higher Regional Court for retrial and decision. お知らせ • Sep 21
Biofrontera AG(XTRA:B8F) dropped from S&P Global BMI Index Biofrontera AG(XTRA:B8F) dropped from S&P Global BMI Index お知らせ • Aug 19
Biofrontera AG announced that it has received €7.91445 million in funding On August 18, 2020, Biofrontera AG (XTRA:B8F) closed the transaction. The transaction was over subscribed. お知らせ • Jul 31
Biofrontera AG announced that it expects to receive €7.91445 million in funding Biofrontera AG (XTRA:B8F) announced a private placement of 2,638,150 qualified subordinated mandatory convertible bond at a price of €3 per bond for gross proceeds of €7,914,450 on July 27, 2020. The bonds will mature on December 20, 2021 and bear interest at 1% per annum. The bonds are subject to the grant of statutory subscription rights. Each of the convertible bonds can be converted into no-par ordinary registered shares of the company with a notional interest in the share capital of €1 per share and a right to dividends from the year of the share issue. The initial conversion price per share is €3.00. The initial conversion ratio is 1:1. The bondholders are obliged to convert their bonds at the maturity date of the convertible bond. The company is entitled to convert the convertible bonds into shares at any time if a trigger price defined in the terms and conditions of the convertible bonds has been met. The shareholders are granted the preemptive right to the convertible bonds as an indirect subscription right through Quirin Privatbank AG. The subscription price will be published in the Federal Gazette (Bundesanzeiger) and via an electronic publication no later than three days before the end of the subscription period. The subscription price will be based on the stock exchange price of the company's shares (ISIN: DE0006046113) at the time the subscription price is determined and will not exceed 100% of the nominal value of the convertible bonds of €3 each. The subscription price will be established based on the ratio of the stock exchange price of the shares of the company to the nominal value of the convertible bonds as a percentage of the nominal value of the convertible bonds, whereby a discount of up to 10 % may be applied to the percentage determined by this method. The transaction has been approved by the board of directors and management of the company. お知らせ • Jul 23
Biofrontera AG to Report First Half, 2020 Results on Aug 26, 2020 Biofrontera AG announced that they will report first half, 2020 results on Aug 26, 2020 
