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Leverkusen, Germany (pta068/27.04.2023/23:20) - Leverkusen, Germany - Biofrontera AG (ISIN: DE0006046113), an international biopharmaceutical company, today published its consolidated results for the fiscal year ended December 31, 2022. At the same time, the company reports on current operational developments and provides guidance for 2023.
2022 Financial Highlights
* Total revenue amounted to EUR 25.7 million.
* EBITDA amounted to EUR 1.9 million
* Profit before tax amounted to EUR -43 million
* Cash and cash equivalents amounted to EUR 6.4 million as of December 31, 2022
* Successful capital increase with gross issue proceeds of around EUR 7.1 million
|Research and development expenses||-7,128||-7,009|
|General and administrative expenses||-5,932||-30,781|
|Result from operating activities||1,591||-35,341|
|Other expenses and income||465||60,001|
|Income before income taxes||-43,210||35,683|
|*adjusted EBITDA/EBIT for one-time effects from the deconsolidation of BF Inc. in 2021|
Operational developments in 2022
* Appointment of Pilar de la Huerta Martínez as Chief Financial Officer
* Appointment of Dr. Axel Drews as Vice President Global Sales & Marketing to strengthen global sales activities
* Establishment of Biofrontera UK Ltd. for further marketing of Ameluz® in the United Kingdom
* Product launch of Ameluz® in Finland by Galenica AB
* Withdrawal of the government price decree for Ameluz® in Spain
* Delisting of ADS from Nasdaq
* Grant of a US patent for a nanoemulsion formulation
* Inclusion of the patent for the novel RhodoLED® XL lamp in the FDA Orange Book
* FDA approval of Biofrontera Pharma as a contract laboratory for batch control and stability testing for Ameluz®.
"In the year under review, we made great progress towards our goal of transforming the Biofrontera Group into a profitable company. After Biofrontera had been generating losses over the past decades, we were now able to generate positive EBITDA and EBIT from our operating business, a significant step towards financial independence and profitability. The restructuring of the Biofrontera Group has enabled us to achieve significant cost savings, which were also made possible by other cost-cutting measures, such as the delisting of Biofrontera AG from the US capital market. We will now consistently pursue this path by focusing on growth promoting efforts, a decision in which the Management Board and the Supervisory Board are working together in a very trusting and, above all, result-oriented manner," comments Pilar de la Huerta, CFO of Biofrontera AG, on the results of the last financial year.
Financial guidance 2023
The Group expects sales of EUR 27 to 33 million in fiscal year 2023. However, sales success will continue to depend heavily on the respective regional economic strength and the resulting dynamics in both the US and Europe.
Assuming a recovery in global economic strength, Biofrontera AG expects positive EBITDA of EUR 3 to 5 million and positive EBIT of EUR 2 to 4 million in 2023. Furthermore, assuming a further recovery of the markets, the company expects further sales increases as well as positive EBITDA and EBIT in the mid single-digit million range from 2024 onwards.
From today's perspective, taking into account the earnings expectations, the Group has sufficient liquidity in the coming 12 months with a level of cash and cash equivalents of EUR 6.4 million in the Group as of December 31, 2022 and a capital increase approved in January 2023.
Sales performance in Germany was more subdued year-on-year. German product sales amounted to EUR 4.8 million compared to EUR 5.3 million in 2021, a decrease of approximately 10%. This development was mainly caused by re-imports from Spain due to the price decree in force there until April. Sales of tube-based Ameluz® grew by around 2% in the reporting year compared with 2021, with growth of 8% year-on-year in the fourth quarter. The share of Ameluz® PDT in the PDT segment was almost unchanged at 64% in 2022.
In the rest of Europe, Biofrontera achieved product sales of EUR 3.5 million, compared with EUR 3.3 million in 2021, an increase of 5%. Ameluz® also showed dynamic growth of 16% in the UK market. After Galenica AB had already started marketing Ameluz® and BF-RhodoLED® in the Scandinavian countries and now also in Finland, Medac Gesellschaft für klinische Spezialpräparate mbH was now also able to start marketing in Poland in the middle of the year, probably initially only in the private healthcare sector with selected customers.
Marketing in the USA
Sales to the sales partner in the USA, Biofrontera Inc., amounted to around EUR 16.5 million in the period under review, down 18% on the previous year. In the previous year, however, sales were still fully consolidated as own sales, whereas since the spin-off of Biofrontera Inc. they are now accounted for on a pro rata basis. According to Biofrontera Inc., it was able to increase its market share in the target market by 12%.
Other key financial figures
The year-on-year comparison of results is burdened by one-off effects. The spin-off of Biofrontera Inc. in the previous year led to a significant increase in EBITDA and EBIT; adjusted for this effect, both key figures EBITDA and EBIT show a clearly positive development.
With an increase of 2% to EUR 7,128 thousand in the reporting year, research and development costs were roughly on a par with the previous year's figure of EUR 7,009 thousand.
General and administrative expenses amounted to EUR 5,906 thousand in fiscal year 2022 (previous year: EUR 30,781 thousand) and thus decreased by a total of EUR 24,875 thousand compared to the previous year.
Selling expenses amounted to EUR 6,357 thousand in fiscal year 2022 and thus decreased by EUR 16,066 thousand compared to the previous year (EUR 22,423 thousand), mainly due to the costs of Biofrontera Inc. in the amount of EUR 16,874 thousand included in the previous year's figures.
In addition to the interest result, th financial result totaling EUR -44,334 thousand (previous year: EUR 11,022 thousand) mainly includes the impairment of the at-equity investment in Biofrontera Inc. amounting to EUR -44,172 thousand (previous year: EUR 14,729 thousand).
The company has EUR 6.4 million in cash and cash equivalents at the end of the reporting period. The consequences of the Covid pandemic and the Ukraine crisis are burdening the company's liquidity situation, as there are bottlenecks in particular in the procurement of raw materials for lamp production and the company has to make significant advance payments here to guarantee delivery dates. This is the reason why Biofrontera has already had the implementation of an ordinary capital increase with the granting of subscription rights approved in an extraordinary general meeting in January 2023. This capital measure is being prepared and the offer is expected to be published during July 2023.
Regulatory and clinical progress
In the period under review, various patents were granted in addition to approval for the indication expansion of Ameluz in Switzerland for the treatment of actinic keratosis on other body regions. However, the progress of the clinical development program, targeting US new labeling, fell somewhat short of expectations. There were delays in patient recruitment due in part to regulatory changes to the protocol. Patient recruitment for the Phase I safety trial could now be completed in March 2023 with the treatment of the 100th patient. In the Phase IIb study on the efficacy of Ameluz® in moderate to severe acne, just under 20% of the required patients had been enrolled by the end of the year. The start of a further phase III trial on the efficacy of Ameluz® PDT in actinic keratosis with the aim of extending the indication to the treatment of the extremities, trunk and neck took place in Q4 2022 with initially 2 trial centers. The first patient was already screened in December 2022 and the treated in January 2023.
emitter: Biofrontera AG
address: Hemmelrather Weg 201, 51377 Leverkusen
contact person: Investor Relations
phone: +49 (0) 214 87 63 20
ISIN(s): DE0006046113 (share)
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