Biofrontera Inc. (BFRI) Q3 2019 Earnings Report, Transcript and Summary

Dear ladies and gentlemen, welcome to the conference call of Biofrontera AG. 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, Head of Investor Relations who will lead you through this conference. Please go ahead, madam.

Thank you, Judith. Good morning, and welcome to Biofrontera's earnings conference call for the first nine months of 2019. Earlier this morning, we issued a press release announcing financial results for the nine months ended June 30, 2019. We encourage everyone to read today's press release as well as the earnings report, both of which are available on Biofrontera's 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, including our annual report on Form 20-F and subsequent filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, today, November 19, 2019. Biofrontera undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With that, I would now like to turn the call over to Prof. Dr. Hermann Lübbert, our CEO. Hermann, go ahead. Hermann Lübbert: Thank you, Pamela. And thank you very much, ladies and gentlemen, for taking the time today to participate in today's call. With me here is Thomas Schaffer, our CFO. Christoph Dünwald, our Chief Commercial Officer, excuses himself today for health reasons. I will summarize the general business development and clinical updates during the reporting period and will provide an update on the current status of our commercial efforts. Mr. Schaffer with then present the financial results for the period – for the reporting period. In the first nine months of 2019, we continued to observe a positive business performance. Driven by revenue growth and clinical developments we were able to further expand our global positioning as the leading specialty pharmaceutical company in dermatology and thus create sustainable value for you, our shareholders. Compared to the same period last year, we increased our total sales by around 31% to €19.1 million. Growth was driven in particular by the German and the US markets. Our sales increased by around 59% to €3.1 million in Germany, while, in the US, revenues from our sales of Ameluz amounted to €13.6 million, an increase of 33%. Following a slowdown in growth momentum in the USA over the summer months, we're now observing a significant upturn in the US business in the fourth quarter of 2019. Mr. Schaffer will shortly go into more detail on the key financials for the reporting period. The strong growth in Germany is due to the European approval for daylight photodynamic therapy – short, PDT – last year. This label extension enabled us to make a significant leap forward in the largest European pharmaceutical market. Ameluz is the clear leader in Germany, ahead of its competitors. For comparison, this year's nine-month revenue corresponds to the entire annual German revenue in 2018. Of course, we are very pleased with the success in our home market. We intend to further consolidate this excellent positioning by investing in our marketing efforts in Germany. This will enable us to further increase the benefits of Ameluz and photodynamic therapy for prescribing physicians. We expect to increasingly grow our market share, especially at the expense of topical creams for certain application. In Spain, we continue to see a very positive market performance for Ameluz. A strongly growing number of Ameluz prescription – that is the number of Ameluz tubes sold – offset a government-mandated price reduction of 27% for Ameluz and maintain sales at the previous year's level. We are, therefore, fully on track for our budgeted market growth. In the United Kingdom, the focus of sales continued to be on hospitals, in particular on the administrative steps to include Ameluz in the respective hospital pharmacies. In some major hospitals, Ameluz is now classified as the first choice therapy for PDT for actinic keratosis and basal cell carcinoma, ahead of the competing product. These achievements are already beginning to be reflected on the revenue figures. Nevertheless, the UK still plays only a minor role in our overall business. In other European countries, sales declined slightly overall due to declining deliveries to license partners. The biggest impact on our biggest business performance, however, is our revenue in the largest pharmaceutical markets, the United States. We generate between 70% and 75% of our total revenues there. As just mentioned, we recorded US sales of €13.6 million between January and September of this year, around €3.4 million more than in the same period in 2018. This figure includes €677,000 generated with the former Cutanea products, Xepi and Aktipak. The growth in the US market is primarily due to the expansion of sales infrastructure and improved reimbursement for Ameluz since the beginning of the year. All-in-all, we see a global revenue growth of more than 30% since the beginning of this year and despite even higher expectations also of our sales. This is a very solid and pleasing business development. Nevertheless, in the summer of this year, the growth momentum in the US weakened more than expected. The third quarter was well below expectations. The comparison with the same period of the previous year had only a limited impact here as the price increase on October 1st, 2018 left September sales figure soaring and sales for that year were, therefore, overestimated in the third quarter. However, since October, following the typical seasonal nature of the summer months, we have again been able to record significantly stronger growth in our US business. In the future, we expect sales growth in the US to continue to increase at a sustained rate, especially since two of Ameluz's current competitive disadvantages over its competition will be eliminated. On the one hand, our current FDA approved prescribing information only allows the reimbursement of one tube of Ameluz per patient per day. This restriction on the Ameluz label is reflected in the reimbursement guidelines for Ameluz issued at the end of 2018. In other words, there is no problem with the reimbursement of Ameluz by health insurers per se, but our label is restricted at this point. We're working hard to improve this section on the Ameluz label as well as to extend the approval to the treatment of actinic keratosis on the extremities, tongue and neck. Currently, Ameluz is, in the US, approved for the treatment of the face and scalp only. As you may be aware, Biofrontera has already successfully conducted a Phase III study on the use of Ameluz on other body regions, the results of which were submitted to the European Medicines Agency for label extension in September of this year. In January 2020, we expect the US Food and Drug Administration, the FDA, to provide us with feedback regarding our corresponding label expansion in the United States. In order to ensure the reimbursement of several tubes used simultaneously for the treatment of larger peripheral body regions in the future, we started preparing a pharmacokinetic study a few months ago in which the safety of the treatment with three tubes of Ameluz will be tested. The preparatory work for the study has already been completed, including the development and validation of analytical procedures and the study protocol is currently being finalized with the FDA. Another competitive disadvantage relates to our PDT lamp, which is significantly smaller than the competitor's product and does not meet the standard of the US market in this respect. Our BF-RhodoLED has been developed at the time with the goal of obtaining approval in the US as quickly as possible. Its key features correspond to those of the lamp we used for our Phase III studies. The similarity of both lamps has allowed us to obtain FDA approval for the combination of Ameluz and BF-RhodoLED with data collected using the other lamp without further Phase III trials. To meet the needs of the US medical community, we're developing a new, larger PDT lamp, the BF-RhodoLED-XL, which allows the use of Ameluz on larger surfaces. The final prototype of BF-RhodoLED-XL is almost ready and the application for approval is expected to be submitted by mid-2020. In that sense, three parallel developments play together. The approval of the treatment of actinic keratosis in the periphery, the treatment of larger body areas with up to three tubes of Ameluz and the development of a larger lamp designed for these applications. In combination, we expect these measures to significantly improve our market share. In order to further increase our growth opportunities in the US market in the medium term, we're currently conducting a clinical trial in the USA for the treatment of superficial basal cell carcinomas with Ameluz in combination with red light lamp, BF-RhodoLED. Since September 2018, we have been working intensively on patient recruitment, which, however, takes longer due to the highly demanding study protocol required by the FDA. Following successful FDA approval, Ameluz would be the only drug in the United States for the treatment of superficial BCC with PDT. We also see long-term growth opportunities in the US PDT market through the contract with the US Department of Veterans Affairs – short, VA – for the sale of Ameluz in its hospitals. Although we have not yet generated any significant sales as a result of this cooperation, we have yet to grant the discounts demanded there. I would like to take this opportunity to briefly explain the significance of this market segment for our long-term market development. Many dermatologists in training in the USA work in the hospitals of the VA. If a prospective dermatologists has the opportunity during the education to get acquainted with PDT and what we consider to be the best PDT drug, namely Ameluz, it is highly probable that he or she will continue to use PDT with Ameluz after the residency. It is also important to educate a new group of key opinion leaders and innovation drivers in dermatology about the benefits of PDT and, of course, Ameluz who will become the key drivers in the US dermatology market in the future. That's why the VA hospitals remain a strategically important market even though we have not yet achieved larger sales in this environment. Without wanting to exaggerate, we continue to rate Ameluz potential in the world's largest pharmaceutical market as enormous. In order to exploit the current market potential and establish our product even better in the short and medium-term, we continue to focus on the so-called low-hanging fruits – dermatologists who are already familiar with photodynamic therapy. At the same time, however, we are also working hard to convince dermatologists who have no experience with photodynamic therapy of this treatment option in order to expand the overall PDT market in the US. As part of the successful integration of Cutanea Life Sciences, Inc., or Cutanea for short, which we acquired from our strategic partner and major shareholder Maruho in March 2019, we have expanded our product portfolio in the US to include the FDA approved drug, Xepi. In this context, I would like to briefly explain to you what led to the temporary suspension of Aktipak, the second prescription drug of the Cutanea portfolio. This was a development that we could not foresee when we acquired the Cutanea product portfolio. The discontinuation of Aktipak was by no means our intention, though we never thought the market potential was comparable to those of Ameluz or Xepi. We were, therefore, however, confronted with unexpected quality problems in the production of our Aktipak, which could not have been addressed in the short-term and could only with larger investments have been resolved in the long term. We didn't want to consider this to be justified for Aktipak, a decision that was supported by Maruho who bore all the financial consequences of the discontinuation. Now to Xepi, in which we see considerable long-term market potential. Xepi is the first newly approved topical antibiotic on the US market in about 10 years. With this product, Biofrontera is introducing the next major innovation into the US dermatology market. Xepi is proven to be effective against antibiotic-resistant bacteria such as MRSA and is expressly approved by the FDA for infections with [indiscernible] bacteria. In total, around 10 million prescriptions are issued annually in the US market for drugs in indications where Xepi can be effective, a large part of them by dermatologists. We, therefore, see significant growth potential for Xepi. We plan to complete the first full integration of Cutanea by the end of fiscal year 2019, including the winding up of Cutanea as an independent company. As stated in the acquisition agreement, Maruho has paid or will pay for all costs of this restructuring. Ameluz, however, is and will remain our most important product in the near future as we continue to exploit Xepi's market potential and further optimize our marketing strategy. If Ameluz is to remain our most important sales driver, label extensions in the form of new indications are extremely important for us. As you know, we plan to develop Ameluz for use in acne together with Maruho, our longstanding strategic partner and major shareholder. To this end, we recently prepared the development plan to expand the indication for Ameluz for acne and requested a meeting with the FDA for its approval. The results of this important meeting, which are expected in January, will then serve as the foundation for the further contractual arrangement of our cooperation with Maruho. Of course, we will keep you informed of further progress as it becomes available. We have also made progress in our research cooperation with Maruho for the further development of branded generics based on our nanoemulsion technology. We have now initiated all necessarily investigations and manufacturing steps for the entry into the clinical phase. Branded genetics are a welcome addition to our product portfolio for the future and we're proud to have found Maruho as the long term and reliable partner for the development of these products. Independent development of branded generics in combination with our nanoemulsion would not only be a very long and resources consuming process for Biofrontera, but would also involve a high development and market risk. Given our strategy, which is clearly focused on optimizing the commercialization of the existing portfolio, it would be a mistake to try to develop further products on our own and invest our own financial resources in this area. We are, therefore, grateful that the strategic cooperation with Maruho will enable us to pursue this path nevertheless in order to leverage further potential for Biofrontera in the longer-term. But as already mentioned, the main focus and the commercial success of Biofrontera in the coming years will remain with Ameluz. With these words, I hand over to our CFO, Thomas Schaffer.

Thank you, Hermann. And a warm welcome to everyone on the line. I would now like to give you an overview of the financial results for the first nine months of 2019 and then the outlook for the rest of the financial year. First of all, I'd like to say that Biofrontera continues to develop. Since our market entry in the US, sales have been rising steadily. And in the current financial year, we're continuing our dynamic revenue growth. As Herman mentioned at the beginning, continuous strong growth does not always happen in a linear fashion. This is nothing unusual in growing a business, especially in a company with such a short history as Biofrontera. Let us now turn to the financial figures for the Biofrontera Group. In the reporting period, we achieved a total revenue of around €19.1 million compared to around €14.6 million in the nine months of 2018. This corresponds to an increase of 31%. The reason for this was again mainly the strong growth in the US, flanked by the dynamic growth in Germany. Our most important pillar by far, however, is and remains the US market. Sales in the US improved in the reporting period by 33% to around €13.6 million compared to €10.2 million in the same period last year. Sales in Germany amounted to around €3.3 million in the first nine months of this year compared to €2.1 million in the same period in 2018. This corresponds to an increase of 59%. Our sales in the other European countries decreased in the reporting period by 14% to approximately €1.8 million compared to €2.1 million in 2018. This decline was due to a decline in deliveries to license partners. I would like to emphasize at this point in time that, despite the substantial price reduction, sales in Spain were on a similar level than in the prior-year period. The increase in sales in Europe overall, including Germany, continues to be primarily attributable to the successful marketing of daylight PDT, which was approved in March 2018. Gross profit increased by €3.1 million to approximately €14.9 million compared to €11.8 million for the first nine months of 2018. The gross margin decreased to 78% from 81% in the same period of the previous year. Research and development costs remained largely stable at around €3.2 million compared to the prior-year period. These costs include our costs for clinical studies, but also regulatory expenses such as fees for the granting, maintenance and expansion of our approvals. General and administrative expenses came in at approximately €12.1 million in the reporting period compared to the €7.3 million in the same period last year. As a result, G&A expenses increased by €4.8 million. This includes around €2.1 million in administrative expenses for Cutanea. It was further mainly due to the significantly increased legal and consulting costs for the defense of the DUSA Pharmaceutical lawsuit as well as administrative costs in the US. Sales costs amounted to around €20.6 million, a significant increase of almost €8 million on the previous year. This was due, on the one hand, to the cost for the further expansion of our US sales infrastructure and €4.6 million in sales costs incurred by Cutanea. Selling expenses include the costs for our own sales force in Germany, Spain, UK and in US, as well as marketing expenses. Other expenses and income totaled €20.8 million in the reporting period. This includes the negative difference of $14.8 million in assets and liabilities measured at their fair market value resulting from the purchase price allocation, including €6.3 million in income from the charging of startup costs to Maruho. This item also includes charges to Maruho under the share purchase agreement of €4.5 million. The estimated income from the purchase price allocation as well as income from the offsetting of expenses incurred by Cutanea in the half-year period were adjusted in the total amount of approximately €3.6 million in the reporting period. In the period under review, there was no actual cash settlement of start-up costs to Maruho. Expenses and income from currency translation are also included in this item. As a result of the difference from the purchase price allocation of Cutanea [indiscernible] recognized in the income statement, Biofrontera reported a net loss of around €3.3 million or €0.06 per share for the first nine months of 2019 compared to a loss of €12.7 million or €0.28 per share last year. Cash and cash equivalents amounted to €12 million as of September 30th, 2019, a decrease of around €7.5 million as of December 31, 2018. This includes cash and cash equivalents of Cutanea amounting to €2.1 million. That was it for the financial performance part of the first nine months of 2019. I would now like to conclude with the guidance for the 2019 financial year. Hermann has already indicated that despite notable growth, overall business performance especially in the US was below expectations of the executive board. We, therefore, have to adjust our sales and earnings expectations for fiscal year 2019. This adjustment is further due to the sharp increase in legal costs as a result of litigation with DUSA Pharmaceuticals, which were higher than expected. We now expect revenue to be in the range of €28 million to €31 million instead of the previously planned €32 million to €35 million. We are adjusting our forecast for net income in 2019 to a loss of €4.6 million compared to a profit of €4 million to €7 million previously. This will be influenced in particular of our adjustment to the other income as part of the purchase price allocation as a result of the Cutanea acquisition. This was still provisional at the time of the last quarterly report. Contrary to our expectations, we, therefore, are unlikely to reach the operating breakeven point in the fourth quarter of 2019. However, I would like to emphasize that we continue to see the fourth quarter as a revenue driver, especially with Ameluz upcoming price increase in the US on January 1, 2020. The month of December, just like September last year, thus remains virtually unpredictable. And still, we have decided as a precaution to adjust our expectations downwards due to the weaker summer months. At this point, I would like to hand over to Hermann for some closing remarks. Hermann Lübbert : Thank you, Thomas. At this point, we would like to invite you, dear shareholders, to the Extraordinary Shareholders' Meeting to be held on Thursday, December 19th, 2019. This is already the second Extraordinary General Meeting this year. And once again, our shareholder, Deutsche Balaton AG, together with its subsidiary, Deutsche Balaton Biotech AG, called for the meeting which makes this the continuation of the long-lasting dispute that has been going on for years. With its demands, Deutsche Balaton clearly shows that it is still not interested in a co-operative partnership with the management board of Biofrontera AG and that Deutsche Balaton AG is once again pushing the limits of what is legally permissible. Being a responsible management board, we nevertheless extend our hand to Deutsche Balaton AG and have convened this additional shareholder meeting as requested despite considerable legal concerns. In essence, Deutsche Balaton AG demands, first, the submission of the expert opinions on the tender offers of Deutsche Balaton Biotech AG and Maruho Deutschland GmbH of last summer. Second, an amendment to the articles of association regarding capital increases that are advantageous for Deutsche Balaton AG. Third, discussion of the investor relations measures of the management board. Fourth, a vote for the stall of confidence for the management board. We have already given our detailed comments on these points in the invitation to the meeting, but would like to take this opportunity to briefly address our counterproposal for the creation of new authorized capital. The possibility of a passive capital increase is important for a publicly listed company. However, the approach of Deutsche Balaton AG to this possibility suggests that it does not primarily in the interest of Biofrontera AG and all shareholders. Although Biofrontera already has the possibility to increase the capital, I remind you of the resolution of the annual general meeting on May 24, 2017, which has been blocked by Deutsche Balaton for years. Deutsche Balaton AG would now like to cancel this resolution and have it replaced by its own resolution proposal, which, in particular, sets the maximum price of the issue shares for the next five years at €4. In the interest of equal treatment of all shareholders and the benefit of the company, we do not consider this to be appropriate and have, therefore, put our own, more balanced proposal to the vote. That is all on this topics. Now back to the operational business. I will conclude today's telephone conference with a summary that we are on a sound growth path, which we will maintain. Due to the tough competitive disadvantages just described in our largest market which emerged in 2019, sales in the third quarter in particular fell short of our expectations. Due to our flexibility that comes with being a smaller company, however, we can react quickly and have initiated countermeasures such as the change in approval for several Ameluz tubes over development of BF-RhodoLED-XL. Due to the strict regulatory environment in the pharmaceutical sector, these measures, however, will not immediately bear fruit. In the coming year, we will, therefore, have to continue to operate within the given competitive framework. Even in this environment, we have been achieving growth of over 30% so far this year. The market potential of Ameluz and, of course, Xepi is enormous and we look forward to continuing to redefine the global dermatology market with our innovative products. We're confident that we will continue to successfully implement our growth strategy and thank all employees and shareholders as well as the Supervisory Board for their continued support on our way of developing Biofrontera into a multi-product dermatology company. And now, I would like to open the line for questions.

Thank you. [Operator Instructions]. First question is from Bruce Jackson, The Benchmark Company. Your line is now open.

Hi. Good morning. Thank you for taking my questions. The first thing I want to get into is the extra-large lamp. Is that going to be a 510(k)? And when do you think that might be on the market? Hermann Lübbert: Well, this is not a 510(k) because it's part of a combination product that's driven by the drug side of the FDA. So, we think that we'll be able to submit this lamp in the middle of next year to the FDA. And then, if everything goes according to plan and the UFDA agrees with our thinking on this, then we should have the approval within about six months.

Okay. So, the ramp is going to be then tied to the drug – it's a combination product. Okay. And then, secondly, with the basal cell carcinoma trials, specifically, do you have a rough idea of when you might complete enrollment for that trial? Hermann Lübbert: I don't think that we will have the results of that trial prior to 2021.

Okay. And then, one last question on the shares that the management team tendered earlier this year, what are your current holdings in the company? And then, do you still have the intent of, at some point, buying back into the shares that you've previously tendered? Hermann Lübbert: Yes. We have already bought in to a certain amount back in. I have, together with my life personally, hold now around, I don't know the exact number, but it's around 90,000 shares. And Thomas has currently purchased 10,000 shares. And we do intend to acquire more shares. But we are, obviously, waiting for also the results of the upcoming shareholder meeting.

Okay. Okay. Alright. That's all I needed. Thank you very much. Hermann Lübbert: Thank you.

The next question is from Russ Blair, Arik Securities [ph]. Your line is now open.

Hi there. Thank you for taking my questions. Just a couple today. Firstly, could you possibly provide a comment on what was driving the slower-than-expected sales in the US during the summer months? Secondly, what do you anticipate your capital requirements for next year might be? And lastly, what – could you also provide comment on what your legal costs have been this year and what you might expect for next year as well? Thank you very much. Hermann Lübbert: If I start with questions one, on the slower development in the summer months, last year, we had a price increase on October 1st, which was heavily driving September sales, particularly in the last three weeks. And when we were planning this year's sales, we simply underestimate the general seasonality in Q3 because last year's results were sort of obstructed by that effect. And these were the only – this was the only basis for comparison we had in planning. When we look at what happened, then we were actually behind the results of last year only in the last three weeks of September and all other weeks prior to that were higher than previous year. So, this is clearly related to the price increase in October.

Thank you.

And, unfortunately, we cannot at this point in time, give an outlook or forecast or anticipation for next year. And to your question around legal costs, so far in 2019, we have incurred some €5 million already.

Perfect. And are you able to give an estimate on what you expect legal costs to be next year?

Not yet. We cannot unfortunately give any estimates for any period beyond 2019 at this point in time.

I understand. Thank you very much.

You're welcome. Hermann Lübbert: Thank you.

Your next question is from Thomas Flaten, Lake Street Capital Markets. Your line is now open.

Good afternoon, guys. Thanks for taking the questions. Can you – given the significant increase in legal costs, have there been developments in the DUSA litigation beyond what you had anticipated? Any color that you could provide there? Hermann Lübbert: This is difficult because a lot of this is done between the lawyers and it's also lot of the material that has been exchanged is also confidential to us. It's I think fair to say that DUSA is not interested at a settlement we would like to settle or we have been offered to settle a long time ago because any kind of settlement would be cheaper than the legal costs. But this is clearly not the intention of Sun Pharma.

Great. And then, the updated guidance of €28 million to €31 million, does that include Cutanea. I think previously you had excluded Cutanea from your revenue guidance. I just wanted to clarify if that was included or excluded from them. Hermann Lübbert: No. That range includes Cutanea product, which is basically only one left.

Okay. And then, final question, the gross margin in the third quarter was reduced sequentially. Could you comment on that? What led to the reduction in gross margin?

Well, it's a blended margin. So, it's a mix of the various margins on the products. And then the mix of – and the rate of the various products within a given period of time on the one hand. It's further geared to the mix of in which markets we are selling our products. We sell into various markets with our own sales force, however with different prices. And then, we have only 50% on average of the revenue or of the price when we sell to license partners. And then, finally – of course, this is changing to some extent the amount of other sales cost or cost of sales that we incur. Like, for instance, upgrading our manufacturing facilities.

Thank you, guys.

It's within the range where our margins usually are still.

Thank you.

Thank you, Thomas. Hermann Lübbert: Thank you.

At the moment, there are no further questions. [Operator Instructions]. As there are no further questions, I would like to hand back to Ms. Keck.

Thank you, Judith, one more time. Thank you all for joining the call today. Hope we were able to answer your questions and provide some color on the Q3 and nine-month numbers. And wish you a nice rest of the day. Thank you. Hermann Lübbert: And also, thank you from my side for taking the time today and being a Biofrontera shareholder. Thank you very much.

Thank you. And have a good day, everyone.

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