Biofrontera Inc.

Thank you. Good morning, good afternoon and welcome to Biofrontera's earnings conference call for the financial year 2020.

Yesterday, we issued a press release summarizing the financial results for the 12 months ended December 31, 2020. We encourage everyone to read the press release as well as the annual report both of which are available on our website at www.biofrontera.com.

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 SEC filings.

This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast today, April 13, 2021. Biofrontera undertakes 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 our CEO, Hermann Lübbert.

Yes, 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.

In our press release, a few weeks ago, we briefly introduced him and welcomed him to our ranks. Now during today’s conference call, he will take the opportunity to introduce himself to you in person and explain the key financials of the past supporting period in more detail.

I would like to start with a summary of last year's business development, providing you with an update on our sales performance as well as an update on the development on the clinical side. A challenging year lies behind us all.

The impact of the global pandemic on society, politics and the world economy was immense. And as such, also had a significant impact on Biofrontera's business performance.

We were able to respond promptly and flexibly to the crisis at our various corporate offices by implementing a series of effective countermeasures. Protecting the health of our employees and business partners was our top priority.

We immediately initiated cost saving measures and due to the down payment from the Japanese company, Maruho, relating to the Ameluz license agreement for East Asia and Oceania, as well as the 40-plus convertible bond in August, we were able to successfully mitigate the negative effects and secure the liquidity of the company. During 2020, we experienced a slight decline in revenues of about 3% compared to the previous year, although the actual decline in revenues from product sales was significantly higher at 22%.

Despite the pandemic, we were able to further expand our market share of PDT prescriptions in our domestic German markets to 62% compared to 57% in 2019. We also observed an expansion of the PDT segment for actinic keratosis treatments with PDT being used in 7.1% of the treatments in 2020 compared to 6.6% in 2019.

This increase of 0.5% appears low at first glance, but illustrates that due to the size of the overall market for actinic keratosis treatments, even slight shifts can have a significant impact on our revenue development. While this growth is of course far from our target, it confirms that the expansion of the PDT segment is the key to Biofrontera's economic success.

As a result, we were able to achieve an increase in sales of around 11% to €5.1 million in 2020 in Germany, compared to €4.6 million in 2019 despite the pandemic. Our German sales team successfully leveraged an approval extension to the treatment of actinic keratosis on the body and extremities, which took place in March 2020 as well as current study results even during the crisis to familiarize dermatologists with the benefits of Ameluz.

The advantages of tailored PDT, which can be performed in good weather and in particular, without direct contact with doctors became particularly clear during the summer months. In the rest of Europe, however, the pandemic led to a decline in product sales to €2.1 million compared to €2.6 million in the same period last year.

In Spain, where we saw a very positive sales development at the beginning of 2020 until the outbreak of the pandemic, however, business almost completely collapsed due to the very strict lockdown regulations. In the United Kingdom, sales remained at a low level for almost the entire year due to the pandemic and sales for our distribution partners also contributed only a very small share to total sales.

As in the previous year, the USA is an important growth driver for Biofrontera with a slightly lower share of 55% of total sales in 2020 due to the pandemic. The subdued sales development in the reporting period therefore clearly affected Biofrontera on the revenue side.

For the full-year 2020, Biofrontera generated revenues of approximately €16.6 million in the U.S., representing a decrease in revenues of approximately 29% compared to 2019. Following the reorganization of the operational management of the subsidiary, Biofrontera, Inc.

at the beginning of the reporting period, all important key positions in the U.S were filled locally and the setup of the sales structures was further advanced in 2020. Our U.S sales and marketing team currently consists of approximately 40 employees.

The sales force is supported by our medical consulting team, our market access and the customer service team. We have sold well over €50 million worth of Ameluz in the U.S since its launch there, thus establishing the product on the U.S market and propelling it for further growth.

Compared to our domestic market, Germany, the U.S PDT market did not develop very well during the pandemic. There, the share of all PDT prescriptions among all actinic keratosis treatments decreased from 2.1% in 2019 to 1.8% in 2020.

Patients attendance times in doctors' offices related to PDT treatment certainly played a decisive role here and led to U.S dermatologists being more reluctant to opt for PDT. Furthermore, Ameluz is a so-called buy-and-bill drug, which means that it is initially purchased by the physician on his own account and subsequently billed to the patient or the patient's insurance when used.

The pandemic and accompanying lockdown restrictions have made it much more difficult for dermatologists to plan financially, further compounding the negative impact on the PDT market. At the same time, however, the share of Ameluz prescriptions within the PDT segment has expanded from 22.6% previously in 2019 to 24.5% now in 2020, meaning that while the pandemic has impacted the use of PDT as a form of therapy, Ameluz has been able to secure a slightly larger market share in PDT prescriptions, meaning that it has come through the pandemic at least somewhat better than the competitor product.

In the reporting period, Xepi, our new antibiotic generated only marginal sales, which we believe is due to the still very low level of awareness, which necessitates a high frequency of visits by the sales force for prescriptions from new customers. This is something we are working on in the current year.

Xepi accounted for €0.3 million of sales compared to €0.6 million in the previous year. A relaunch to improve the positioning of Xepi is being targeted for the second-half of 2021.

In the meantime, all major private payers have committed to unrestricted reimbursement of Xepi so that about half of the residents in the U.S have unrestricted access to Xepi. This, together with a new co-payment program that we launched on April 1st in 2020, provides a strong foundation for the future commercialization of Xepi.

The fact that payers are willing to cover the higher price of Xepi compared to its generic competitors without restrictions, confirms the tremendous benefits and great potential of this stock. The licensing deal with Maruho has enabled Biofrontera to enter another sales region in East Asia and Oceania.

Under the agreement, Maruho can develop Ameluz for all indications, approve it in these countries and marketed. Biofrontera can use the necessary clinical studies for the rest of the world free of charge.

Biofrontera will provide Maruho with Ameluz at cost plus 25% overhead and received an upfront payment of €6 million when the agreement was signed, and further milestone payments and royalties on sales later on. In joint development meetings, Maruho regularly informs Biofrontera about the progress of the development.

In Europe, we have signed a marketing agreement with Galenica so that Ameluz will soon be available again in Scandinavia. Because of the pandemic it has not yet been possible to finalize the planned agreement with medac GmbH for the marketing of Ameluz in Poland.

Regarding research and development, we were able to announce another approval extension within the EU in March 2020, whereby Ameluz PDT may now also be used on extremities and the tongue or neck. In October 2020, the pharmacokinetics study for the use of three tubes of Ameluz on larger or multiple surfaces was completed in the USA.

In February 2020, the corresponding application to amend the product information was submitted to the FDA. This study became necessary in order to be able to remove the reimbursement restrictions of Ameluz as our current approval only allows the use of one tube per treatment.

This creates a significant disadvantage compared to the competitor product, which is also reimbursed for the use of up to three packs per treatment. Likewise, in response to the preferred treatment of larger areas in the USA, Biofrontera developed a novel highly adaptable PDT lamp that provides a total of five variable illumination panels.

After 3-year development period, we were able to submit the application for approval to the FDA at the end of March this year. In addition, we are preparing studies in the USA to allow the treatment of actinic keratosis also in the periphery as the approval there currently only covers the head [indiscernible].

In this case, the FDA required additional clinical studies. We are planning to start patient recruitment before the end of 2021.

The submission for label extension could then be made in 2022 or 2023. This was regard to the possible approval extension for Ameluz -- of Ameluz for acne in the U.S., Biofrontera has drawn up a corresponding development plan and received feedback from the FDA on the design of required clinical trials.

The study program is also scheduled to begin in the second half of 2021 with a Phase 2b trial. Aiming to further increase our growth opportunities in the USA -- U.S market, in the medium term, we are currently running a Phase 3 clinical trial for the treatment of superficial basal cell carcinoma in the United States.

Since September 2018, we have been working intensively on patient recruitment, which is taking a considerable amount of time due to the extremely demanding study protocol, which is so ever stipulated by the FDA. We therefore do not expect this trial results until later in 2022.

Following successful FDA approval, Ameluz would be the only drug in the U.S for the treatment of superficial BCC, a tumor indication with PDT. Clinical development processes are generally cost intensive, complex and lengthy in nature.

As such, they must be strategically well prepared for the long-term, especially if they are to be initiated in a way that preserves liquidity. With our flagship product Ameluz, we’re still a pipeline and a product company that develops and expands markets by broadening the label of Ameluz despite the growing importance of Xepi in the future.

This means that as a product matures, it is necessary to plan precisely which indication extensions are feasible and financially viable in order to achieve the desired result, namely the best possible support for sales to expand market share. In Germany, we have already achieved significant success with this strategy.

In particular, through the introduction of Daylight-PDT, we have consolidated market leadership within the PDT sector in our domestic market, as already explained and expanded the share of PDT among the therapy options available. Certainly, we would have wished for one or the other step to have been taken earlier and faster.

But we have to remember that Biofrontera is a specialty pharmaceutical company that operates in a highly regulated market segment and has very little financial leeway in international standards. However, we are convinced that the chosen business strategy and corporate development have to be consistently pursued even during the pandemic if we are to secure the company's goals in the longer term.

Consequently, we are now also pursuing this path in the USA, our largest market, in order to improve the positioning of our product in line with market requirements and patient needs. I would now like to hand over to our CFO, Ludwig Lutter, who will take the opportunity to introduce himself to you and then present our financial figures for the past year and provide you with the forecast for the current fiscal year.

Thank you, Hermann, and thank you all for joining us here today in this call. I would like to now give you an overview of the financial results of last year and an outlook for 2021.

Given that this is my first conference call as CFO at Biofrontera, I would like to briefly introduce myself before we move on to the business part. As you probably already know, I've been Chief Financial Officer of Biofrontera since March 1 of this year, which is just under 6 weeks.

Before that, after completing my studies in the U.S., I was CFO at brillen.de, HRS, Astaro [ph], which was acquired by SOPHOS and also two publicly listed companies, Intershop Communications AG and Poet Holdings, Inc. The latter, like Biofrontera, was listed in Germany as well as in the U.S.

So my capital market experience therefore spans both sides of the Atlantic, which I will also be bringing to Biofrontera. I must admit that I could hardly have chosen a better time to be appointed CFO, I mean, which CFO is not delighted to start a company -- in a company where a capital increase has just been successfully completed, and the financing of the corporate strategy secured for the time being.

Turning now to the key financial figures. Hermann just -- has already discussed the revenue developments, our key market and our key markets in the pandemic year 2020.

To better understand the full extent of the impact of the pandemic and thus, our financial results, let me reiterate in more detail. As we've just heard, the corona crisis has led to a declining number of treatments and thus to sharp declines in sales, particularly in our key sales markets, the United States.

On March 20 of last year, i.e., shortly after the pandemic spread of the virus became known, the company announced that it was taking comprehensive preventative measures to reduce and control costs. As such, short-term work was introduced for all employees in Germany until the end of July of 2020.

Similar measures were implemented in the subsidiaries in Spain and the U.K. U.S subsidiary Biofrontera Inc.

had also initiated significant cost cutting measures. There, the workforce was significantly reduced and a furlough program was introduced under which all employees were required to take temporary unpaid leave.

In addition, the members of the Management Board and the Supervisory Board of Biofrontera AG, the parent and the management of Biofrontera Inc., voluntarily waived a part of their compensation. Furthermore, among other things, cost and non essential training and continued education were reduced in the reporting year.

While these cost saving measures were in effect, the company was able to still ensure full compliance with all legal requirements in medical and capital market regulatory respect without interruption as well as meeting all continuous disclosure obligations. Due to COVID-19 crisis, the continued challenging business environment has impacted the valuation of some of the company's assets and liabilities.

During the crisis, the sales strategy in the U.S market has focused on our flagship product Ameluz and the target that relaunch to improve the positioning of our in-licensed product Xepi has been delayed. The reduced sales of Xepi led to a reassessment of the medium term business and earnings prospects for Xepi, and thus to an impairment of Xepi -- of the Xepi license in the first quarter of 2020.

To a minor extent, inventories were written down as of December 31, 2020 due to an anticipated expiration of shelf life. Beyond this, no significant risks have arisen in relation to financial instruments, particularly no extraordinary write downs of receivables.

So what does it actually mean for our results? On the cost side, especially for G&A expenses as well as sales expenses, we saw a significant reduction compared to the previous year due to cost saving measures introduced in the COVID-19 pandemic.

G&A expenses amounted to €9.2 million in fiscal 2020 compared to €16.3 million in the previous year. This was mainly due to the aforementioned cost saving measures as well as lower legal and consulting expenses of just under €2 million compared to €6.9 million in 2019.

Sales and marketing expenses amounted to €20.5 million, a significant reduction compared to previous year's figure of €28.9 million. The effects of the cost saving measures implemented were offset by a noncash impairment of Xepi -- of the Xepi license in the amount of €2 million.

€4.8 million in research and development costs which also include the expenses for maintaining regulatory approvals were the only item of expenditure in the reporting period that was slightly above the previous year's level of €4.6 million. At €7.6 million in 2020, the loss from operating activities improved by €15.8 million compared to previous year loss of €23.4 million, mainly as a result of cost cutting measures and the effects on the first time consolidation of Cutanea included in the previous -- in previous year's figures.

What is particularly encouraging and I'd like to point your attention to is that we've reached the operating breakeven point at group level for the first time in the fourth quarter of 2020. Other income and expenses totaled €2.4 million in the reporting period compared to the previous year income of €21.2 million, whereby again, the previous year figures includes one-time effect from the acquisition of Cutanea Life Sciences, Inc., amounting to €21 million.

In 2020, translation expenses of €3.6 million were included compared to a currency translation gain of €0.3 million in 2019. As a result, our loss before tax for 2020 was €12.6 million compared to a loss of €4.8 million in 2019.

I would now like to turn briefly to the current development of our business, which I'm pleased to report its showing [technical difficulty] in the first quarter of 2021, based on the preliminary sales figures. Thereafter, I will turn to the guidance for the current year.

As already reported last Thursday, when we published the preliminary unaudited revenue numbers for Q1, revenue in the first quarter of this year has not yet reached the level of the previous period and was approximately €5.6 million compared to €6.5 million in 2019. While revenues in Germany maintain -- remained relatively stable compared to the previous year.

Revenue in the U.S., in January and February were still significantly lower than last year. The pandemic became noticeable in our revenues from the second half of March 2020 onwards.

And from this point on, the significant upturn was evident in the U.S this year compared to 2020. In March, we were able to increase our sales by approximately 46% year-on-year indicating a significant recovery of the situation in the U.S., which is probably also the [technical difficulty] and destination.

We're confident in the continued recovery and look forward to the coming year even more than in fall of last year before the positive clinical results of the corona vaccines. Turning on to the outlook and guidance for our key financial indicators.

First of all, I would like to emphasize that even after a year of exposure to the coronavirus crisis, it is still difficult to assess global business developments during the pandemic. The forecast for the full year 2021 reflect our assessment of the timing and speed of recovery from the pandemic.

We expect that due to the vaccination programs, the pandemic will slowly subside in our most important markets, allowing growth momentum to become apparent and show results in the second half of 2021. At group level, we expect revenue from product sales between €25 million to €32 million in fiscal 2021.

I would like to emphasize once again that our sales and therefore business activities are highly dependent on the further course of infections and the associated easing of containment measures. I would also like to point out that starting with 2021 reporting year, EBITDA and EBIT will be introduced as key performance indicators in our reporting.

Both have been established internationally as target metrics and will replace the previously reported KPI results from operation activities. As a reminder, group EBITDA includes earnings before interest, taxes, depreciation of tangible and amortization of intangible assets.

EBIT includes earnings before interest and taxes. These KPI indicators are suitable for describing and comparing operating performance as non-operating fluctuation variables, for example, valuation adjustments and amortization of acquired assets are not included.

Based on the assumptions mentioned above, we expect that EBITDA loss between €11 million and €14 million and an EBIT loss between €13 million and €16 million at group level for 2021. And on the last key indicator, liquidity.

From today's perspective, considering the earnings expectations with the cash and cash equivalents of €16.5 million as of December 31, 2020, and the capital increase carried out in February of 2021 with gross proceeds of around €24.7 million, the group is sufficiently funded for the coming 12 months, at least. That pretty much sums it up for my part.

And at this point, I'd like to hand over back to Hermann, for some concluding remarks.

Yes. Thank you, Ludwig.

Now before we turn to the to the questions, I would like to comment briefly on the status of the various lawsuits. Two such lawsuit is ongoing, and unfortunately we were not able to reach an agreement, so the next step will be to enter into the actual trial of the case in front of a jury.

The court has already set a preliminary date for this jury trial, which is scheduled to begin at the end of November 2021. However, this may be further delayed.

We take the clear position that these lawsuits are without merit, and intend to do defend ourselves vigorously. Of course, this does not guarantee that we will be successful in doing so.

However, DUSA's request for an injunction to stop our sales activities has already been largely rejected by the court, with the court merely stating that Biofrontera may not use any documents or information derived from documents that originated from do so. Contrary to German conventions, legal costs in the U.S are generally not borne by the losing side.

So that Biofrontera must continue to expect substantial legal costs in the coming year, which will not be reimbursed to the company even if the outcome of the trial is positive for Biofrontera. On the other hand, we dropped our own lawsuit against DUSA last year, as the accused business practices were largely discontinued by DUSA, following an investigation of the Department of Justice and the legal costs incurred would therefore not -- therefore have been disappropriate to the added value.

The ruling of the Cologne Higher Regional Court regarding the action for annulment filed by the Balaton group against the resolutions of the 2017 Annual General Meeting was set aside by the Federal Court of Justice and referred back to the Cologne Higher Regional Court for a new hearing and decision. The decision on the action for annulment against resolutions of the 2019 Annual General Meeting is still pending.

Our lawsuit against the Balaton group and Mr. Zours in New York is currently suspended due to the mediation process between the two parties.

The ruling of the Cologne Higher Regional Court regarding the action for annulment filed by the Balaton group -- second in the mediation process with the Deutsche Balaton group, we asked the U.S court by mutual agreement for further extension until the end of August 2021, which was granted. Moving the Annual General Meeting to August is already a result of these discussions.

The pandemic, but also the uncertainty surrounding our shareholder structure, did not do our share price any good. Despite the successfully completed significantly oversubscribed capital measures, the share price has not yet been able to discover sustainably.

However, we would like to solicit our confidence that we have strategically positioned Biofrontera in the best possible way to generate sustainable growth. The pandemic has certainly hit us hard on the sell side in the USA, so that we have not yet achieved the planned sales goals and thus also the financial independence of Biofrontera.

However, we have not abandoned the path to this goal, but have merely had to slow down the pace so that we remain fully convinced both of our products and of the sales activities that aim to tap the enormous potential. We expect a significant recovery of the general economic situation in the course of this year and subsequently want to continue our steep growth from 2016 to 2019 in a seamless manner.

Finally, we would like to express our sincere thanks to our employees, our supervisory board and our shareholders for their commitment, their support and their loyalty to the company. I would now like to open the line for questions.

Thank you.

Hello, and thank you for taking my question. I'd like to start with the United States marketing strategy.

Originally, the idea was to go out and capture more share within the photodynamic therapy market and then try to make some inroads against cryotherapy Is that still the general idea?

I mean, there's two ways to grow the business are certainly not exclusive, and to an extent, they are both followed up at the same time. However, the major focus, as you indicated, on getting additional market share within the PDT sector and then growing the PDT sector into the larger AK space.

So basically, go after the low-hanging fruit and then continue to expand within cryotherapy?

Exactly.

And then a follow-up question, if I may. The approval for the use of three tubes in a label, when do you expect to get the FDA labeling?

And then after that, do you have to go back to the payers to get the clinical policies updated?

Yes, we hope to get the FDA labeling in the course of this year. And then with the changed prescribing information, we will have -- in principle, we will have to go back to the payers.

However, while the FDA process is ongoing, we do plan to initiate discussions with the payers basically in parallel to the FDA process.

Okay, great. Thank you very much for taking my questions.

Thank you, Bruce.

Great. Thank you for taking the questions.

Just wondered if you could qualitatively and perhaps even quantitatively explain what are the factors that would drive the guidance towards the lower end versus the higher end, obviously, an easing of the pandemic, but more specifically, what are some of the factors you're looking for? And is there a timing associated with that?

I know you said second-half, but I just wonder if you could give us some more color on that - on the guidance range.

Yes. I mean, it's quite obvious that the lower end of the guidance is close to last year and the higher end is close to 2019 prior to the pandemic.

So it's clearly our hope that in the course of the year, we'll be able to get back to where we were before the entire pandemic started and then continue the growth from there in a similar way that we grew in earlier years. And now the driving factors really the way in which, first of all, the immunization and vaccination program in the U.S., most importantly in the U.S.

for us continues, and this develops quite positively as we all know. And then as a consequence of that, how fast the society goes back to be much more open again, similar to it was before we ever had the pandemic.

And particularly, the second part is a little bit of an unknown because there are many psychological factors included in that to which extent, for instance, people who are vaccinated feel safe. So, I think all the data suggests that they should feel safe, but that doesn't necessarily mean that they do.

And so we have some unknowns here that could delay the society from getting back to normal by a certain time. And this time, of course, can have quite some influence on our sales in the course of the year.

It won't have any influence in the long-term development of the company, but particularly this year, it could shift sales towards the higher or towards the lower end of the forecast.

Okay. I appreciate that.

Thank you. And then with respect to March, you mentioned in your release last week as well as on the call today that there was a significant uptick in March, particularly in the second-half.

I was wondering if that was -- so was that just sales that came not as a surprise, but were those sales associated with increased rep access? Or were you hearing anything qualitatively from the sales reps about physicians driving more patients?

And I'm just curious if you could provide some color around what the factors were that drove March, the way that successfully came through?

I think March -- the growth in March is already an indication of the society opening up. When we look at the sales in March, they are certainly better than they were last year as we published by compared to last year, a 46% growth, but they were not as good as in 2019.

So there is still room for growth.

Got it. And what are you hearing from your sales reps with respect to access?

Have they started getting back into offices more than they might have been at the beginning of the year?

Absolutely, yes. We see an opening of the offices again, not back to 100%.

But compared to January and February and certainly last year, we do already see an improvement.

Great. I appreciate you taking the questions.

Thank you.

Thank you.

Hi. Thank you for the follow-up question.

I wanted to talk about Xepi briefly, which is a very well differentiated drug. But the first time that it came on to the market, there were some issues with the way that the reimbursement was structured.

So in the course of the upcoming relaunch, have you made any changes to the reimbursement structure to make sure that the drug is readily available?

Yes, we -- first of all, we have achieved agreements with basically all the larger private payers in the U.S system, such that about half the U.S population now gets unrestricted access to Xepi. Unrestricted means there isn't any kind of pre-approval process and it's the necessity to try other drugs first.

However, there is still -- there can be still a co-payment by the patients. And to alleviate that we have introduced the copay card such that the financial burden on the patient is, I think not very high.

So the patients pay in the end $35. So I think that's acceptable -- will be acceptable to most patients.

And first of all, the reimbursement by the private payers plus and the copay card that should allow Xepi to actually grow. The problem that we see with Xepi and this is the result of other market research study that we did about it is that the awareness of Xepi within the medical community is still very low, which is good news, actually because it's something that we can work on and it's much better than have the result being that there is any problems that doctor see with a drug.

And just the lack of awareness, that's probably the best thing that a marketing group can actually get as a starting point.

All right. That's helpful.

Thank you. And then just one last question, not to belabor the point on the market recovery.

But when do you think you might return to the 2019 sales levels?

We do certainly hope that -- until the middle of the year, the major impact of the pandemic is over and that the second half of the year, we'll be back to where we were.

All right. Thank you very much.

Thank you.

Thank you everyone for joining today's call, and enjoy the rest of your day.

Yes.

Yes. Thank you all very much for taking the time.

And talk to you next time.

Bye.

Thanks, everybody.