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Leverkusen (pta003/30.04.2022/08:30) - Biofrontera AG (ISIN: DE0006046113, US OTC: BFAGY), an international biopharmaceutical company, published yesterday its consolidated results for the fiscal year ending December 31, 2021. The company also provided an overview of current operational and clinical developments .
Key financial figures 2021
* Total revenue decreased by 5% to EUR 28.8 million, compared to EUR 30.3 million in 2020.
* 20% increase in product-only revenue compared to 2020.
* EBITDA was EUR 28.0 million, compared to EUR -4.7 million in 2020.
* Profit before tax was EUR 20.9 million, compared to EUR -12.7 million in the previous year.
* Both EBITDA and EBIT include significant one-off effects from deconsolidation.
* EBITDA of EUR -11.8 million and EBIT of EUR -15 million after adjusting for one-time effects, including those from deconsolidation, are both within the forecast range.
* Cash and cash equivalents totaled EUR 6.9 million as of December 31, 2021, compared to EUR 16.5 million as of December 31, 2020.
| TEUR | 2020 | 2021 | |
| Net sales | 30,346 | 28,787 | |
| * thereof product sales | |||
| 23,853 | 28,787 | ||
| Research and development expenses | -4,789 | -7,009 | |
| General and administrative expenses | -9,150 | -30,781 | |
| Sales expenses | -20,482 | -22,423 | |
| Result from operating activities | -7,611 | -35,341 | |
| Other expenses and income | -2,418 | 60,001 | |
| EBITDA | -4,696 | 27,950 | |
| EBIT | -10,029 | 24,661 | |
| Income before income taxes | -12,697 | 35,683 | |
| adjusted for one-time effects | |||
| EBITDA adjusted | -10,696 | -11,772 | |
| EBIT adjusted | -14,028 | -15,062 |
Operating and clinical developments in 2021
* Execution of a capital increase in February 2021 with gross proceeds of approximately EUR 24.7 million.
* Signing of a licensing and supply agreement with Medac Gesellschaft für klinische Spezialpräparate mbH for the marketing of Ameluz® in Poland.
* FDA approval of the new red light lamp RhodoLED® XL.
* Successful IPO of Biofrontera Inc. on the US Nasdaq stock exchange.
* Receipt of two US patents related to the RhodoLED® lamp series.
* Start of patient recruitment for the safety study on the use of three tubes of Ameluz® in one PDT treatment, and for the phase IIb study on the treatment of acne with Ameluz®.
"Encouragingly, product sales have rebounded significantly in 2021 with a 20% increase and we believe that the pandemic-related restrictions should no longer have a significant impact on our business performance. This commercial success has been driven by a broad base of operational and clinical achievements. With the independence of Biofrontera Inc., Biofrontera AG will now clearly focus on the European business, coupled with the revenue share from the US under the license and supply agreement, this also brings Biofrontera AG's profitability within sight", commented Ludwig Lutter, CEO of Biofrontera AG, on the results of the last financial year.
Important developments in the year under review
The key achievement in the year under review was the successful IPO of Biofrontera Inc. and the resulting financial independence of the growing US business.
In addition, Biofrontera was able to start the clinical program for the indication expansion of Ameluz® in the USA and FDA approval was granted for RhodoLED® XL. The patent grants around the new RhodoLED® XL lamp in December represent an important step in strengthening the competitive advantage and protection of Ameluz® and the RhodoLED® lamp series under the FDA combination approval.
As a result of the mediation agreement reached with the Deutsche Balaton Group in December, the mutual legal disputes were settled and a jointly proposed Supervisory Board was elected at the Annual General Meeting.
Also still in December 2021, an out-of-court settlement was negotiated with Dusa Pharmaceuticals Inc. shortly before the start of the jury trial. The settlement was reached based on the following key points: The Company as well as its defendant subsidiaries have agreed to pay DUSA USD 22.5 million in settlement of potential claims. In addition, further mutual claims have been released. Half of the settlement amount was due upon execution of the agreement, thereafter one quarter is payable on each of the first and second anniversaries after execution of the agreement. Of this amount, 50% will be borne by the Company and 50% by Biofrontera Inc.
Conference Call
The Management Board of Biofrontera AG will provide information on the key developments in the reporting period in a conference call on Monday, May 02, 2022.
The conference call for shareholders and interested investors will start at 11:30 a.m. in German and at 2:00 p.m. in English.
Conference call - GERMAN
May 02, 2022, 11:30 a.m. CEST (4:00 a.m. ET)
Dial-in number: +49 69201744220
Confirmation number: 47974148 #
Conference Call - ENGLISH
May 02, 2022, 2:00 p.m. CEST (8:00 a.m. ET)
Dial-in number USA: +1 8774230830
Dial-in number UK: +44 2030092470
Confirmation number: 59031521 #
Please dial in as early as 10 minutes prior to the start of the conference call to ensure an on-time start.
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About Biofrontera:
Biofrontera AG is a biopharmaceutical company specializing in the development and sale of dermatological drugs and medical cosmetics. The Leverkusen-based company develops and markets innovative products for the treatment, protection and care of the skin. Its key products include Ameluz®, a prescription drug for the treatment of non-melanoma skin cancer and its precursors. Ameluz® has been marketed in the EU since 2012 and in the USA since May 2016. In Europe, the company also markets the Belixos® dermocosmetic series, a specialty care product for damaged skin. Biofrontera is one of a few German pharmaceutical company to receive a centralized European and a US approval for a drug developed in-house. The Biofrontera Group was founded in 1997 by Prof. Dr. Hermann Lübbert and is listed on the Frankfurt Stock Exchange (Prime Standard) and on US OTC market (BFAGY). www.biofrontera.com
Forward-looking statements: Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "anticipate", "believe", "predict", "estimate" and "intend", among others. Such forward-looking statements are based on current estimates and assumptions made by Biofrontera AG's management to the best of its knowledge and belief, which in their opinion are reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, financial condition, performance or achievements of the company or industry to be materially different from any future results, financial condition, performance or achievements expressed or implied by such forward-looking statements. No undue reliance should be placed on such statements. Forward-looking statements speak only as of the date they are made, and the Company undertakes no obligation to update or revise any forward-looking statements.
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emitter: Biofrontera AG
address: Hemmelrather Weg 201, 51377 Leverkusen
country: 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 exchanges: regulated market in Frankfurt, Dusseldorf; free market in Stuttgart, free market in Munich; open market in Berlin, Tradegate
other stock exchanges: US OTC