Biofrontera AG: BIOFRONTERA REPORTS RESULTS FOR THE FINANCIAL YEAR 2023

Leverkusen, Germany (pta033/30.04.2024/10:15 UTC+2)

Biofrontera AG (ISIN: DE0006046113), an international biopharmaceutical company, today published its consolidated results for the financial year ending December 31, 2023. At the same time, the company reports on current operational developments and sets the forecast for 2024.

Key financial figures for 2023

Operating developments in 2023

• Significant increase in German sales with over 30% growth compared to the same period of the previous year
• Extension of the European approval of Ameluz® for the treatment of actinic keratoses with artificial daylight
• Approval of a new formulation of Ameluz® by the European Medicines Agency (EMA)
• Start of phase III clinical trial in the USA for the treatment of actinic keratosis on the extremities, neck, and trunk with Ameluz®-PDT
• US patent granted for an innovative photodynamic treatment protocol
• Market launch of belixos® ACTIVE CARE, a novel cosmetic active ingredient foam
• Completion of patient recruitment in the pivotal trial for the treatment of basal cell carcinoma with Ameluz® PDT
• Positive results of the phase I safety study on photodynamic therapy (PDT) with three tubes of Ameluz®
• Approval of an optimized formulation of Ameluz® for the treatment of actinic keratosis by the US Food and Drug Administration (FDA)
• Sales forecast achieved in the upper third
• EBITDA and EBIT forecast exceeded

"This year, we succeeded in generating clearly positive EBITDA and EBIT in our operating business, which confirms Biofrontera's strategic realignment," commented Pilar de la Huerta on the business performance of the last financial year. "The extremely pleasing development in the operating area, which was characterized by various milestones in the regulatory area, impressively demonstrates that the restructuring of Biofrontera after the divestment of the US business is proceeding smoothly. Our excellent sales result in Germany also shows that the PDT market continues to have significant growth potential. Over the past few years, we have been able to establish ourselves as an innovation driver in the PDT market by continuously developing our products and adapting them to the needs of doctors and patients. The relationship with our licensing partner in the USA has also developed very positively over the course of the financial year, meaning that we have now also been able to agree on an improved collaboration for both companies in the area of clinical development by amending the license agreement."

Financial forecast 2024

Due to a change in the inventory policy of our US licensee, which will reduce their large inventory in the current financial year 2024, Biofrontera Inc. will decrease their order volumes considerably. As a result, we expect sales of EUR 20 to 23 million for the financial year 2024 due to a decrease in order volumes from the US compared with 2023. EU sales will continue growing, but not to a level where the decrease in the US orders can be completely offset. In addition, the adjustment of the transfer price due to the transition of the clinical research program in the second half of this year will have an impact on the level of sales, although this decline will be fully offset in terms of earnings by the reduction in research and development costs, as all the clinical trial program will be moved to Biofrontera Inc. from June 2024 onwards. While the decline in sales will be in the order of EUR 10 million, EBITDA will not be as heavily impacted due to the reduction in expenses for clinical trials that will be transferred to Biofrotnera Inc., and the cost saving policy of the company. EBITDA will be in the break-even range between EUR -1 and 1 million in 2024. For EBIT, we are forecasting a result of EUR -2 million and break-even.

As soon as Biofrontera Inc. stabilizes its stock level, they will return to the order volume growth pathway, expected for 2025.

As of December 31, 2023, the Biofrontera Group had cash and cash equivalents of EUR 3,080 thousand. Based on the current corporate planning for 2024 and the assumption of a successful capital measure, the Group will have sufficient liquidity to meet all obligations for a further 12 months from the date of preparation. This assumes that a capital measure will result in a cash impact of EUR 3 million in May/June 2024. Assuming expenses and income develop as planned and the capital measure described above, the Group plans to have cash and cash equivalents of between EUR 3 million and EUR 4 million as of December 31, 2024.

Marketing Europe

Sales development in Germany was extremely positive compared to the previous year. German product sales amounted to EUR 6.3 million compared to EUR 4.8 million in 2022, an increase of around 31.4%. The share of Ameluz® PDT in the PDT segment remained almost unchanged at 65% in 2023.

In the remaining European countries, Biofrontera generated product sales of EUR 3.7 million, compared to EUR 3.5 million in 2022, an increase of 4.7%. In the UK market, Ameluz® showed dynamic growth of 9.3%, whereas sales development in the Spanish market was slightly below expectations. With sales of EUR 9.9 million across whole Europe, we were able to grow by 20.1% compared to the previous year (previous year: EUR 8.3 million), confirming that our focus on European business is now also having an impact on sales.

Marketing US

Biofrontera Inc., the sales partner in the US, generated sales of EUR 22.1 million in the reporting period, an increase in sales of 34.3% compared to the previous year. Biofrontera Inc. built up a larger stock of Ameluz® in 2023, which is now to be monetized in 2024 through a changed stockpiling policy.

Further key figures

The company had forecast EBITDA of between EUR 3 million and EUR 5 million for the 2023 financial year and even exceeded this forecast with actual EBITDA of EUR 5.9 million. At EUR 5.1 million, EBIT for the financial year also exceeded the forecast of EUR 2 to 4 million. Essentially, Biofrontera was able to significantly strengthen the revenue side, so that the moderate increase in costs had less of an impact on the results than expected.

Despite the positive EBITDA of EUR 5.9 million, earnings before income taxes amounted to EUR -2.1 million in financial year 2023 (previous year: EUR -43.2 million) due to losses in connection with the company's investment in Biofrontera Inc.

With an increase of 10.1% to EUR 7.8 million in the reporting year, research and development costs were slightly above the previous year's level of EUR 7.1 million due to the development of the clinical program. General administrative expenses amounted to EUR 6.1 million in the 2023 financial year (previous year: EUR 5.9 million), a slight increase of EUR 199 thousand compared to the previous year, mainly due to some extraordinary consultancy activities. Sales and marketing expenses amounted to EUR 7.3 million in the 2023 financial year, an increase of EUR 917 thousand on the previous year (EUR 6.4 million), mainly due to increased marketing expenses in connection with the expansion of approval to include artificial daylight and exploratory costs for market expansion in other European countries.

Regulatory and clinical progress

An improved Ameluz® formulation was approved in both the USA and the EU during the reporting period. The new formulation may have a positive effect on the safety profile of the gel and avoid potential risks regarding the formation of impurities and allergic reactions. Biofrontera has also submitted a patent application to protect this new formulation. In the EU, the EMA has approved the extension of the marketing authorization for Ameluz® PDT with artificial daylight. Photodynamic therapy with artificial daylight combines the advantages of the original daylight therapy, which significantly reduces treatment pain, with the controlled environment of a doctor's surgery, so that daylight PDT with Ameluz® can now also be used regardless of the prevailing weather conditions.

In the trial testing Ameluz® PDT in superficial basal cell carcinoma, recruitment was successfully completed in August 2023. All patients are now in the 5-year follow-up phase.

The Phase I study required by the FDA to collect additional safety data on the use of three tubes of Ameluz® in a PDT session was completed as planned this year, and the approval dossier was submitted in the USA at the end of 2023.

(end)

Emitter:	Biofrontera AG Hemmelrather Weg 201 51377 Leverkusen Germany
Contact Person:	Investor Relations
Phone:	+49 (0) 214 87 63 20
E-Mail:	ir@biofrontera.com
Website:	www.biofrontera.com
ISIN(s):	DE0006046113 (Share)
Stock Exchange(s):	Regulated Market in Dusseldorf, Frankfurt; Free Market in Berlin, Munich, Stuttgart, Tradegate