Operator:
Dear ladies and gentlemen, welcome to the conference call of Biofrontera AG. At our customer's request, this conference will be recorded. As a reminder, all participants will be in a listen-only mode. After the presentation, there will be an opportunity to ask questions. [Operator Instructions] May I now hand you over to Anke zur Mühlen, who will lead you for this conference. Please go ahead. Anke zur Mühlen: Hello and welcome to Biofrontera's Earnings Conference Call for the First Quarter 2022. On Tuesday, we issued a press release announcing the financial results for the 3 months ended March 31, 2022. We encourage everyone to read the press release as well as the quarterly report, both of which are available on our website. We would like to remind you that in today's conference call, we will only provide a summary of the results. We caution the audience that Biofrontera's management will make forward-looking statements during this conference call. Actual results may differ materially from those expressed or implied by such forward-looking statements due to the risks and uncertainties associated with the Company's business. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, today May 19, 2022. Biofrontera undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With that, I would now like to turn it over to our CFO, Ludwig Lutter. Ludwig Lutter: Thank you, Anke, and many thanks to you, our shareholders, for taking the time to participate in our first quarter 2022 earnings conference call. I would like to give you a brief update on the first 3 months of fiscal 2022 and then present the financial results in a bit more detail. The first quarter is unique -- was unique for Biofrontera because following the deconsolidation of Biofrontera Inc. in December, we're now accounting for the revenue contribution of the U.S business as license revenue for the first time. And in parallel, the operating expenses of the U.S business have been completely eliminated. In sum, we were able to bring Biofrontera AG into the profit zone for this first -- for this quarter, with an overall increase in sales of 20% compared to the same quarter of the previous year, and that despite the consolidation. In the first quarter, Biofrontera generated sales of €6.6 million, which corresponds to the abovementioned increase of about 20% compared to previous year's figure of €5.5 million. In this quarter, we received revenues of €4.8 million from our former subsidiary Biofrontera Inc., which generated revenues of €3.8 million in the same period of the previous year. This represents an increase of U.S sales and just of -- just south of 25%. In contrast, sales in Germany were 17% below the previous year's result of €1.4 million at €1.2 million. However, we were able to more than compensate this decline with a positive sales performance in the rest of Europe with an increase of 140% to €636,000 versus €265,000 last year. More details on this in a minute. Operationally, there were also some very favorable news. The listing of the recently granted patent around the new RhodoLED XL lamp in the FDA Orange Book and the authorization of Biofrontera GmbH as a contract laboratory for batch control and stability testing for Ameluz are important steps towards improving quality assurance and brand protection for Ameluz. To put a little bit more color to that, patents listed in the Orange Book are patents that protect FDA approved products. With that, the FDA has confirmed that the patent hinders generic companies in launching generic products over the next decades until the year 2040. This will strengthen our market presence initially, and also simplify market monitoring in the years to come. The approval of Biofrontera Pharma GmbH as a contract laboratory by the FDA, and previously by the European Medicines Agency, EMA, gives Ameluz quality assurance a broader basis. Previously, quality assurance was performed entirely by Biofrontera's contract manufacturer in collaboration with third-party suppliers. Now Biofrontera Pharma can carry out part of this required testing production batches in -- at the headquarters itself. This reduces dependency on third-party suppliers and the risk of production downtime. There was thrall of the Spanish price decree on April 1 this year was a significant milestone, particularly for the development of our European business. A price cut was imposed on Biofrontera by the Spanish Health Authority in November of 2020, forcing us to reduce the original selling price of Ameluz in the Spanish market by 50%, down from €150 to €75. This reduction came into effect due to an incorrect classification of Ameluz in terms of the concentration of the active ingredient contained. We contested this classification by the authorities in various ways over the past year and half. Firstly, we appealed directly to the authority with an administrative complaint. Secondly, we took legal action against this price decree with success. As a result, the new legislation was imposed. The classification of active ingredients has now been revised so that the incorrect classification of Ameluz has been removed, and Ameluz can now be sold again on the Spanish market for the original price of €150. As we are in a market environment in Europe, where price -- were different pricing threatens price stability throughout the market, the entire European market, we're now very pleased that we have been able to solve this problem. In particular, the German market was confronted with the impact of re-imports resulting from the price reduction, where sales in Q1 lagged significantly behind, although tube sales reached record levels. In the clinical development program, particularly for the BCC, basal cell carcinoma study, positive progress was achieved after patient recruitment was considerably delayed due to the challenging protocol of the Phase 3 study, 75% of the planned 186 patients have been enrolled in the study to date, so that patient recruitment is expected to be completed by the end of this year. Now back to the numbers in more detail. Biofrontera Group generated a total of revenues of €6.6 million in the first quarter of 2022, an increase of 20% compared to the previous year's period, which was €5.5 million. Product sales decreased by €3.7 million year-on-year to €1.8 million, previous year was €5.5 million. However, this is mainly due to a change in P&L line items resulting from the consolidation of the revenue supply of Biofrontera Inc. in the amount of €3.8 million in the previous year. Now revenues from product suppliers to Biofrontera Inc. are under the license agreement were accounted for as licensed revenue in the amount of €4.6 million this fiscal year. Sales in Germany decreased by 17%, compared to the same periods in the -- of the previous year to €1.2 million, previous year was €1.4 million. As mentioned, this decline is mainly due to the re-imports as just mentioned. However, on the basis of numbers of tubes sold, we were able to achieve record levels in Germany. In the other European countries, we were able to increase not only the number of tubes sold, but also total product sales by 140% to €637,000, as opposed to €265,000 last year, again, partly due to a counter effect of these re-imports. Gross profit increased by €877,000 in the first 3 months to €5.5 million compared to €4.6 million at the same period of the previous year. The gross margin decreased slightly to 83% compared to 84% same period last year. Research and development costs increased by 22% to €1.6 million in the reporting period, compared to €1.3 million in the previous year, primarily due to increased clinically research activities. General and administrative expenses amounted to €1 million in the first quarter '22. Previous year was €2.5 million and thus decreased by a total of €1.5 million compared to the previous year. This was mainly due to the deconsolidation of the G&A expenses of the former subsidiary Biofrontera Inc. in the amount of €1.2 million in the previous year, as well as reduced costs for legal disputes, particularly due to the out of court settlement last year of the legal dispute with DUSA Pharmaceuticals. Selling expenses amounted to €1.7 million in the first 3 months, a decrease of €3.1 million compared to the previous year, again, mainly due to the deconsolidation of Biofrontera Inc. as of December 31, 2021, whose share of selling expenses was included in the previous year figure with €3.4 million. The Group's EBITDA improved by €4.4 million to a positive €1.3 million in the first quarter of 2022. In the same period of the previous year, this figure was still negative at €3.2 million. This also -- this is also mainly due to the previously described follow-up effects from the deconsolidation of Biofrontera Inc. December '21. These effects also had a corresponding impact on EBIT, which improved year-on-year to a positive €1.1 million, as opposed to a negative 4.4 -- €4.0 million in the last year. Earnings before income and tax -- before income taxes amounted to negative €28.1 million in the first 3 months of 2022, decreasing by 2020 -- €23.2 million compared to the prior year's figure of negative €4.9 million. This large negative amount is a result from the fair value remeasurement of our investment in Biofrontera Inc. as of March 31, which was initially required to be reported at the market value as of December 31, 2021. Cash and equivalents in the Group amounted to €4.9 million as of March 31, 2022, compared to €6.9 million as of the end of last year. Taking into account the earnings expectations, the capital increase resolved in our extraordinary shareholder meeting on April 7, and the holding of 8 million liquid shares of Biofrontera Inc. Biofrontera AG group consequently has sufficient liquid funds or funds that can be liquidated short-term to implement the group's strategy in the upcoming 12 months, in addition to the possibility of raising debt capital. Lastly, in addition to the lawsuits filed by the Balaton Group in February regarding the competence of the general meeting to decide on the IPO of Biofrontera Inc. last year, we were also served with a lawsuit filed by our second largest shareholder, Maruho Deutschland GmbH on May 16, 2022, complaining about the resolution passed by the extraordinary shareholder meeting on April 7 this year regarding the capital increase. However, in summary, I'm reasonably satisfied with the outcome of the first quarter. Therefore, I would like to highlight Biofrontera Group is well-positioned, particularly after the deconsolidation of Biofrontera Inc. to achieve sustainable profitability, also on an annual basis shortly. And with that, I would like to now open the lines -- the line for questions. Operator: Q - A - Ludwig Lutter: Well, thank you. Yes, after a really favorable quarter looking back and a nice outlook, I can understand that there are not that many questions out there. So we're reasonably happy and satisfied with our business right now. And therefore, I'd like to thank you for your time for listening in and look forward to hopefully presenting some equivalently nice numbers and developments during our next call for the half year review. Thank you very much, and bye. Operator: Ladies and gentlemen, thank you for your attendance. This call has been concluded. You may disconnect.