Earnings Labs

Biofrontera Inc. (BFRI)

Q3 2021 Earnings Call· Tue, Nov 30, 2021

$1.12

-0.88%

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Transcript

Operator

Operator

Dear ladies and gentlemen, welcome to the conference call to discuss the Q3 2021 Earnings Results. At our customers 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. May I now hand you over to Pamela Keck, Head of IR, who will lead you through this conference. Please go ahead.

Pamela Keck

Management

Thank you. Good morning. Good afternoon. And welcome to Biofrontera's earnings conference call for the third quarter, 2021. Yesterday, we issued a press release announcing financial results for the nine months ended September 30, 2021. We encourage everyone to read the press release, as well as the Q3 earnings report both of which are available on our website. Please note that certain information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, Biofrontera's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. All risks and uncertainties are detailed in and are qualified by the cautionary statements contained in Biofrontera's press releases and all SEC filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast today, November 18, 2021. Biofrontera undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. And with that, I would now like to turn the call over to Hermann Lübbert, our CEO. Hermann Lübbert: Thank you, Pamela. And thank you very much, ladies and gentlemen, for taking the time to participate in today's call. With me today is Ludwig Lutter, our CFO. He will present the financial results in a second. Following that I would like to share with you updates regarding our current regulatory and clinical development, as well as the current business performance and activities. But first now to the financial results of the first nine months of 2021. For that, I would like to hand over to Ludwig.

Ludwig Lutter

Management

Thank you, Hermann, and thank you all for joining us today. I'd like to start by providing you with an overview of the financial results for the nine months ended September 30, 2021. Following the challenges resulting from COVID 19 pandemic, the company's experienced a slow start at the beginning of 2021. However, from mid-March onwards, a clear recovery in sales development became apparent. This includes our key market the U.S., where we have been generating sales comparable to pre-pandemic levels again since mid-March. As a result, we can look back on an encouraging nine months period. But first let me talk about the general revenue development. For the period January 1 to September 30, 2021 Biofrontera Group generated total sales of €18.5 million, a 11% decrease compared to €20.8 million in sales in the same period last year. Please note, the total revenue in 2020 - in the 2020 reporting period included a one-time payment of €6 million received by the company under a license agreement in April 2020. Therefore, we believe it is important to compare revenue generated from actual product sales. Revenues from product sales in the first nine months of 2021 were €14.3 million up 29% compared to the first nine months 2020. The year-on-your sales recovery already perceived in mid-March 2021, especially in our largest market -- face market in the U.S. continued, resulting from the recovery of the general epidemic situation in the U.S. as well as in Germany. Due to the pandemic for better comparability, we not only compare the revenue development in the reporting period with the prior year -- with the prior year period, but also the revenue in 2019, the most recent pre-pandemic year. The comparison with product sales in 2019 shows that since the beginning of 2021, product sales…

Operator

Operator

Thank you. The first question we've received is from Bruce Jackson, Benchmark Company. Please go ahead. Your line is now open.

Bruce Jackson

Management

Thank you for taking my questions, and congratulations on all of the progress. My first question is about the revenue guidance and the interpretation. So now that you have successfully spun out the U.S. subsidiary, does the revenue guidance includes sales for the subsidiary? Because when - the guidance was originally put out, it was for the for the total AG entity, so maybe you could just help us interpret the revenue guidance for the rest of the year? Hermann Lübbert: Yes, since Biofrontera AG is still the controlling shareholder of Biofrontera Inc., Biofrontera Inc. is still fully consolidated and such the guidance contains, is unchanged contains both companies.

Bruce Jackson

Management

Okay, good. And then the other question I've got right now is around the mechanics of the licensing agreement for Ameluz two of the U.S. subsidiaries. So it's on - I understand it's on a sliding scale. How is, that managed so - in terms of the revenue thresholds for the licensing fee percentage, is it calculated on an annual basis or is it calculated on a quarterly basis? So when does the licensing fee shift when you hit a certain run rate or does it hit change when you cross certain calendar points is my question? Hermann Lübbert: It's calculated on an annual basis so, the first €30 million -- for the first €30 million in revenue the transfer price is 50% of the net price than for the next €20 million it's 40%. And everything above is 30% and this is calculated on a - on an annual basis. So every first of January, it starts new.

Operator

Operator

The next question is from Thomas Flaten, Lake Street Capital Markets. Please go ahead. Your line is open.

Thomas Flaten

Management

Thanks, and I appreciate you taking the questions. Back to the guidance, could you perhaps it's a pretty wide range about a quarters worth of revenue that's - that you could put between the higher end the lower bound? Can you explain to us a little bit the assumptions that go into either the low end or the high end and what would need to happen to be at one or the other ends of the guidance? Hermann Lübbert: When we look at the assumptions for the lower end - to end up at the lower end, we would have to see significant worsening of the Corona situation to the point that making revenues would be extremely difficult. For the high end as you probably or certainly remember from previous years, we always have this upswing towards the end of the year when the doctors' offices actually filled our stocks. In previous years, we have had a price increase on January 1, this year we have decided not to have a price increase. And because of that we are not certain what to expect from the upswing of - towards the end of the year whether that this will anyway be in the same range. And that could bring us to the upper end of the range or more likely, whether that won't be to the same -- happening to the same extent as in previous years and then we'll probably be comfortably in the range.

Thomas Flaten

Management

And then another question on BFRI. How are you going to manage the cash that's BFRI allocated versus AG allocated? So for example, with respect to sales force expansion in the U.S., would that be BFRI cash. Do they have to contribute to R&D projects that are managed by AG? Could you just give us some insight into how you guys plan on managing that? Hermann Lübbert: Yes, all of this is determined in the license and supply agreement between the two companies. So it's Biofrontera Inc's tasked to take care of marketing and sales expenses. So extending the sales force would be on the books of Biofrontera Inc. It's Biofrontera AG's task to do all the regulatory work to do pharmacovigilance. And to perform the clinical trials these clinical trials that Biofrontera AG has to perform are clearly defined in the other setting. And for those tiles and the one - the two that are just starting, are just two out of that list. For those tiles all the cost will be on the books of Biofrontera AG.

Operator

Operator

Thank you. There are no further questions. So I would like to turn back to you. Hermann Lübbert: Yes. So if there are no further questions, then thank you very much for taking the time and listening and have a nice day.

Ludwig Lutter

Management

Thank you until next time, thank you.

Operator

Operator

Ladies and gentlemen, thank you for your attendance. This call has been concluded. You may disconnect.