Dear ladies and gentlemen, welcome to the conference call to discuss 2018 Full Year Financial Results. 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 Pamela Keck who will lead you through this conference. Please go ahead.

Thank you, and good morning and welcome, everyone. Before we begin the call, I have to go through some household items first. The news release issued this morning has been filed according to the applicable securities regulations and available on the Biofrontera website. Earlier this morning, Biofrontera issued a press release announcing financial results for the 12 months ended December 31, 2018. We encourage everyone to read today's press release, as well as Biofrontera's Annual Report on Form 20-F, which has been filed with the SEC. The Company's press release is also available on the Biofrontera's website at www.biofrontera.com. We encourage you to review the documents in their entirety. Please note that certain of the 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. These forward-looking statements are subject to a number of risks and are qualified by the cautionary statements contained in the press release and SEC filings, including our Annual Report. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, April 29, 2019. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call. With that, I would now like to turn the call over to Hermann Lübbert. Hermann, please go ahead. Hermann Lübbert: Yes. Thank you, Pamela. And thank you everyone for joining us this morning for Biofrontera's full-year 2018 earnings conference call. Today, I'm joined by our Chief Financial Officer, Thomas Schaffer, who will review our financials;…

Thank you, Christoph. And good morning, good afternoon, everyone on this conference call today. I would like to review our financials for the full-year 2018 and then provide guidance for the 2019 financial year. For the full-year ended December 31, 2018, we reported total revenue of €21.1 million, compared to €12 million for the same period in 2017, representing a 76% increase year-over-year. Revenue in the United States grew significantly to €14.9 million for the full-year 2018, compared to €6.3 million in the same period last year, representing a 136% increase. This growth was, as already mentioned as Christoph and Hermann, primarily driven by the expansion of our sales organization, as well as improvements in the reimbursement for PDT for dermatologists in the U.S. Revenue in Germany amounted to €3.3 million for the full-year 2018, compared to €2.7 million for the same period in 2017, representing a 24% increase from the full-year 2017. Our revenue in the remainder of Europe amounted to €2.7 million for the full year 2018, compared to €1.6 million in 2017, an increase of 69%, compared to the same period last year. Growth in Europe is mainly due to the introduction of daylight PDT with Ameluz which was approved in March 2018. Revenues from other regions, which represent revenues from our development project with Maruho were only €130,000 in the full year 2018, compared to the previous year of €1.4 million as we had ended the phase of the collaboration already in March 2018. Our gross profit increased by €6.3 million to reach €16.7 million in the full-year 2018, compared to €10.3 million in the full-year 2017. Gross margin decreased to 79% in 2018, compared to 86% in the previous year. This decrease in our gross margin was primarily due to the one-off costs included in…

Thank you very much. And we will now begin our question-and-answer session. [Operator Instructions] The first question is from Bruce Jackson of The Benchmark Company. Please go ahead. Your line is open.

Hi, everybody. Just a couple of questions about the Maruho agreement. First with the letter of understanding for acne. Does this permit you to begin the clinical trial work? And then, the second part is if thing here [ph] goes well, can you give us just a rough timeline on when you think you might have a final agreement? Are we talking about something that could take a couple of months or something that could take a couple of years? So, just if you could give us a rough idea of when you think this thing might be nailed down? Hermann Lübbert: Well, we are currently in the process of planning the exact clinical trial, a proof-of-concept trial, which then has to be brought forward to the FDA to discuss the study design with respect to FDA approval. Why we do this? By knowing the details of the study design, we will be able to calculate the cost of the study. And that is what's currently determining the timing of reaching a final agreement with Maruho. So, I would expect this final agreement should be signed within very few months.

And then, my other Maruho question is about the development project with one of their compounds. So, can you just talk a little bit about what indication is it for? I suspect this for some sort of inflammatory condition, like maybe atopic dermatitis. But, I just wanted to get an indication from you if that might be the indication that you're working on. Hermann Lübbert: Yes. And principally as it's full of inflammatory conditions, can be applied to a variety of different inflammatory conditions. It's a known active ingredient, which is combined with our nanoemulsion technology to improve its penetration and its safety profile. So, it's really about making something that does already exist better.

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

I wanted to confirm, during Christoph's comments, I believe he said that the combined sales force would be 45 individuals plus 5 managers. Was that correct or did I mishear that? Christoph Dünwald: No. That is correct. We are striving for 40-45 reps, and we keep the management structure that we at the moment.

Okay. And you expected that the integrated sales force to be active starting July 1 or are some of those new sales people already integrated? Christoph Dünwald: So, we’ll strive for having everybody on-board in all the territories at the moment in first of July. We still have a couple of open positions that we have to fill by then but we have two months now time to get the people on board and train them. But there's some great addition that we have to our existing sales force that is coming from Cutanea, and they accepted our offers.

And then, switching gears a little bit. For the BCC study, I believe you mentioned in the release that you would have enrollment completed in the first half of 2020. Do you have an expectation or provide some guidance around timing for submission and what you guys are thinking about relative to timing for commercial launch, assuming everything goes well? Hermann Lübbert: Well, if we can finalize enrollment -- enrollment is the part where we have the least control because this is really done by the physicians. So, that’s going to be completed early in 2020, then the last patient out would be six months after that patient’s in. So, it would then be in the second half of 2020. Once the last patient is out, we believe that within three to six months, we will be able to file the application with the FDA.

Thank you. The next question is from Gary Waanders of Bryan, Garnier & Co. Your line is now open. Please go ahead.

Firstly, on the Q3 submission of Ameluz for the trunk and extremities indication, that extension, roughly what time for the review do you expect in the EU and U.S.? Is it -- do you think about 12 months or so? Hermann Lübbert: Well, in the U.S supplement to an ongoing NDA, an active NDA is usually six months. We expect actually the same in Europe, but the EMA can actually extend the time if they have a lot of questions, which we don't expect them to do. So, we would think that both in the U.S. and the EU, we’re looking at pretty much six months.

And on the manufacturing scale up, the batch scale up, roughly what sort of improvement do you expect in gross margin resulting from that?

Currently, we have, as you say, around 80% gross margin. I would expect that to be in the maybe 5-percentage point range.

And the last one for me is regarding the operational breakeven, you saw it for expecting in Q4. Is that -- without giving guidance for 2020, is that something you expect to then sustain from that point on? Hermann Lübbert: So, without giving any guidance for 2020, I would expect certainly expect that we continue to grow and sustain the business then.

Thank you. At the moment, there are no questions [Operator instructions] We have received a follow-up question of Gary Waanders of Bryan, Garnier & Co. Your line is now open. Please go ahead.

Sorry. Just final one is on the comment about the Maruho tender price being too low. Is there any change then to the price that you would expect as a result of that review? Hermann Lübbert: I think -- and I can only speculate. I mean, this is something that Maruho and Biofrontera don't communicate, also for full legal reasons. So, I would think that for Maruho it is an important goal to achieve 30%. And whether or not the price will be increased, may dependent on the kind of response they get from the market.

There are no further questions. I would hand back to you. Hermann Lübbert: Yes. If there are no questions and we hopefully could answer all the ones that we are asked, I would like to thank you again. Thanks for taking the time to think about Biofrontera and listen to us this morning. Thank you. Bye, bye.

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