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spk03: Welcome to the BioFrontier, Inc. Third Quarter Earnings Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Pamela Keck, head of IR. Please go ahead.
spk01: Thank you, Matt. Good afternoon and welcome to BioFrontera Inc.' 's third quarter 2021 conference call. Please note that certain information discussed during today's call is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that BioFrontera's management will be making forward-looking statements. And that actual results may 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 the live broadcast. today, November 30th, 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. During today's call, there will also be reference to certain non-GAAP financial measures. BioFrontera believes these measures provide useful information for investors. yet should not be considered as a substitute for GAAP, nor should they be viewed as a substitute for operating results determined in accordance with GAAP. A reconciliation of non-GAAP to GAAP results is included in this morning's press release. And with that, I would like to turn the call over to Hermann Lubritz, Executive Chairman of BioFrontier 8. Hermann, please go ahead.
spk07: Hermann Lubritz, Executive Chairman of BioFrontier 8 Thank you, Pamela, and good afternoon, everyone. Welcome to BioFrontera Inc.' 's first quarterly conference call. I would like to start the call with a brief background on BioFrontera Inc., which became a publicly traded company just about one month ago. BioFrontera Inc. was founded in 2015 as the U.S. commercial arm of the Germany-based parent company BioFrontera AG. To provide Biofrontera Inc. with the financial resources necessary to expand its marketing and sales activities, the parent company decided to allow an independent listing on Nasdaq. Our business rests on long-lasting, exclusive licenses to market and sell two prescription drugs in the United States. Both drugs serve multibillion-dollar accessible markets, And the listing allows raising the resources required to build marketing and sales within Biofrontera Inc. such that we can address these huge markets effectively. In addition, the listing on NASDAQ offers us the opportunity to flexibly exploit market opportunities or cover short-term financial needs, such as in the case of the recent 15 million private placement we announced yesterday. The future of the entire Biofrontera group clearly lies in the U.S. market, as this is where our products face the greatest commercial potential. Significantly increasing marketing and sales efforts here is therefore the cornerstone for successful corporate growth. As some of you may know, I am the founder of Biofrontera AG, the German parent company, and have been its CEO since inception. After originally agreeing to extend my term of office on the management board of Biofrontera AG until December 31st, 2022, I have now decided to remain at the disposal of the group for a further three years. However, I would like to devote these three years to where I see the greatest benefit for the entire group, the growth engine Biofrontera Inc. In view of the separation of the two Biofrontera companies I feel that I cannot effectively serve on both boards. Therefore, earlier this month, I submitted my request for early retirement as CEO and member of the management board of the supervisory board of Biofrontera AG. Once the supervisory board of Biofrontera AG has released me from my duties on the board of Biofrontera AG, I will fully devote myself to my duties as Executive Chairman of BioFrontera Inc. Joining me today is Erika Monaco, Chief Executive Officer of BioFrontera Inc. Erika will provide a more detailed overview over the business, our strategy, and our third quarter financial results. Erica has shown outstanding leadership and has been a key contributor to our success in the United States from the earliest stages, from the development of the business structure, processes, and partnerships required to operate and grow to the launch of our licensed products and our commercial success in the markets. With that, I'll turn the call over to Erica.
spk02: Thank you, Herman, and good afternoon, everyone. By way of introduction, I am Erica Monaco, BioFrontera's Chief Executive Officer. Prior to the IPO, I was our Chief Financial and Chief Operating Officer. I've been with the company since our U.S. product launch in 2016. I'm pleased to be here speaking with you today, and I'm excited for the future of BioFrontera. BioFrontera, Inc. commercializes pharmaceutical products and medical devices for the treatment of dermatological skin conditions. Our flagship product focuses on the treatment of actinic keratosis, or AKs as we call them, which are skin lesions that can sometimes lead to skin cancer. Actinic keratosis are caused by excessive exposure to sunlight. We also market a topical antibiotic for treatment of impetigo, which is a bacterial skin infection. Before telling you more about our company strategy and our products, let me introduce you to the financial results of Q3 and the first nine months of the year. In our third quarter financial update, our total product revenues were $4.3 million for the three months ended September 30th, 2021. This is an increase of $1.1 million, or 34%, from our $3.2 million revenue one year ago. The increase was primarily due to higher sales of Amaloose, reflecting volume increases and, to a lesser extent, a higher average selling price. Total operating expenses were $20.4 million and $5.6 million for the three months ended September 30, 2021 and 2020. Cost of revenue increased primarily due to higher sales of Amaloose, selling general and administrative expenses increased $12.9 million, primarily due to an $11.25 million legal settlement expense, and to a lesser extent, selling general and administrative increase due to a marketing campaign expense and increased headcount. Adjusted EBITDA was negative $3.8 million for the three months ended September 30th, 2021, versus a negative $3.1 million during the same period last year. Adjusted EBITDA margin improved from negative 96.2% to negative 88.5%. Net loss for the 2021 third quarter was $16 million, compared with the net loss for the 2020 third quarter of $3 million. Cash and cash equivalents as of September 30, 2021, were $1.7 million. As mentioned, following the quarter close, we raised gross proceeds of $18 million from the IPO. Furthermore, the private investment into our company that we published yesterday has provided gross proceeds of another $15 million to the company. We have also settled through today outstanding warrants, which will provide another $5.8 million in funds to the company. As a growth-stage company, we intend to be opportunistic in regard to potential financing activities, but we believe that the funds available today provide sufficient capital to support operating, investing, and financing activities through at least the next 12 months. Now, moving on to our year-to-date financial results, our total product revenues were $14.9 million for the nine months ended September 30th, 2021, and $10.2 million for the same time in 2020. It's an increase of $4.7 million, or 46%. The increase was primarily due to higher sales of AMLOs and even partially offset by lower sales of ZEPI. Our revenue was directly affected by the global COVID-19 pandemic starting in mid-March of 2020. From that point on, rising infection rates and the resulting official recommendation by the American Academy of Dermatology to care for patients through remote diagnosis and treatment led to significant decline in patient numbers and widespread, albeit temporary, practice closures. After negligible product sales in April of 2020, we observed a slow recovery of our business in the summer of 2020. And later, the first signs of stabilization in line with the usual seasonality of the remaining quarters. Doctors' offices reopened during the second half of 2020, at least in part, and patients showed increasing willingness to undergo in-office treatments for AKs. In the fourth quarter of 2020, we saw a seasonally strong increase in sales. The 46% increase in product sales year-to-date indicates that our revenue is recovering from this pandemic. Total operating expenses were $38.2 million for the nine months ended September 30th, 2021, and $19.7 million in the same month of 2020. In 2020, we had reduced operating expenses to mitigate the risk to buy off an error from COVID-19 and preserve cash by multiple measures, including headcount reductions, mandatory furloughs, freezing of hiring and discretionary spend, voluntary salary reductions from the senior leadership. During the pandemic, we focused our U.S. sales strategy on AMLOs and delayed the targeted relaunch of Zepi to improve product positioning. During 2021, we have resumed hiring, launched various marketing campaigns for our licensed products, and in addition, as mentioned earlier, we have incurred an $11.25 million legal settlement expense during the third quarter of 2021. Adjusted EBITDA was a negative $9.5 million and a negative $9.1 million for the nine months ended September 30th, 2021 and 2020, respectively. Our adjusted EBITDA margin improved from a negative 89% to a negative 63.9% during the same period. Net loss was $23.2 million and $10.8 million for the nine months ended September 30th, 2021 and 2020, respectively. I refer you to the table in the news release we issued earlier today for a reconciliation of GAAP to non-GAAP financial measures. The long-term financial objectives include consistent revenue growth and operating margin expansion. Accordingly, we are focused on rapid market expansion balanced with improved operating efficiencies, including effective resource utilization, information technology leverage, and overhead cost management. Because traditional PDT treatments using a lamp are performed more frequently during the winter, our revenue is subject to some seasonality and has historically been higher during the first and fourth quarters than during the second and third quarters. Given that, we are pleased to see strong revenue growth in the third quarter, and we expect to maintain that momentum as we strengthen our sales efforts and continue transitioning out of the COVID-19 pandemic. We are also pleased that our expenses have normalized for a growth-focused company. Overall, marketing and development goals align to form a commercial strategy that is uniquely positioned by Afentera for leadership in the treatment of dermatological conditions. And with that, I'll briefly illustrate our commercial strategy. As Herman mentioned, on November 2nd, we completed an initial public offering with gross proceeds of $18 million. The IPO proceeds, along with the $15 million private placement that we announced yesterday, and the $5.8 million in cash proceeds from outstanding warrants exercised through today afford BioFrancera the flexibility and strength to advance our position as a leading commercial dermatology company. Our principal objective is to grow sales of our licensed products in the United States. Three key elements to our strategy include the following. First, Expanding sales of our principal product, Amluz, in combination with the BF Roto-led lamps for the treatment of AKs on the face and scalp, and positioning Amluz as the leading PDT product by growing our sales and marketing infrastructure. Second, expanding sales of Zepi for treatment of impetigo by improving the market positioning of our licensed product. And third, leveraging the potential for future approvals and label extensions of our pipeline products through our existing license agreements. Our market expansion strategy is based on bolstering awareness of our products through medical recognition, data-driven sales strategies, and a robust and dynamic commercial infrastructure. We intend to optimize our sales force through more sales territories, strengthening of our medical affairs, and becoming a trusted partner in the medical communities through scientific data publication, KOL interaction, and industry support. Now, let me introduce you to our in-license products, starting with Amalus. As mentioned, our principal product is amylose. The prescription drug is approved for use in combination with our BF roto-led lamp for photodynamic therapy, or PDT as we call it, for the lesion-directed and field-directed treatment of actinic keratoses of mild to moderate severity on the face and scalp. Actinic keratoses are superficial, potentially precancerous skin lesions caused by chronic sun exposure that may, if left untreated, develop into potentially life-threatening skin cancers called squamous cell carcinomas. AK lesions typically appear on sun-exposed areas such as the face, bald scalp, arms, or the back of the hand. They appear as hyperpigmented spots and are often elevated, flaky, and rough in texture. According to the Skin Cancer Foundation, actinic keratosis affects approximately 58 million people in the United States. And if left untreated, up to 1% of those AK lesions could develop into squamous cell carcinoma every year. In 2020, an estimated 12.7 million treatments were performed for actinic keratosis. The most common treatment remains cryotherapy, with an approximate market share of 86%. Topical drugs for the treatment of AKs had a market share of about 12% in 2020, followed by PDT treatments with a 2% share of the market. Despite its market dominance, cryotherapy poses significant disadvantages as a treatment option for AKs compared to sorry, as a treatment option for AKs compared to PDT therapy. As such, the opportunity to strategically target cryotherapy market share is a key focus in our commercial efforts. We see the opportunity to expand the PDT market as a treatment for AK as particularly attractive in patients with more than 15 lesions. We believe there is a treatment guideline pressure towards field-directed therapy as opposed to single lesion therapy, such as with cryotherapy, which may also help further our sales of amylose. Our second licensed prescription drug product is Zepi, a topical antibiotic for the treatment of impetigo, a common skin infection caused by bacteria. Currently, no antibiotic resistance against Zepi is known, and Zepi has been specifically approved by the FDA for resistant strains such as MRSA, and the FDA label covers the use in adults and children two months and older. Impetigo is a highly contagious bacterial skin infection. It occurs most frequently in children ages 2 to 5, but people of any age can be affected. Impetigo causes red sores that most often appear on the face, neck, arms, and legs. Anyone can contract impetigo, and people can get it more than once. Although impetigo is a year-round disease, it occurs most often during the warmer weather months. There are more than 3 million cases of impetigo in the United States every year. In 2020, more than 13 million prescriptions were written for drugs and indications where Zepi can be effective. And one of our key advantages is that about 80% of patients with commercial insurance are likely covered for Zepi. Zepi is distributed through specialty pharmacies and is generally covered by most commercial payers without pre-approval or similar requirements. We believe there is considerable market potential for Zepi in the coming years. Moving on to an update on our ongoing clinical studies. Our clinical development program is designed to complement our commercial strategy by expanding the market positioning of our PDT product Amalus, providing more value to patients, broadening the total addressable market, and offering more favorable treatment options. The studies are performed by the Biophantaria Group and indirectly financed by us through the license and supply agreement for Amalus existing between our companies. We recently announced clinical site initiations for two studies. These include seven sites for a Phase IIb study for the treatment of moderate to severe acne in adults with amylose, as well as eight sites for a Phase I study evaluating the safety of PDT with simultaneous application of three tubes of amylose. The acne study will enroll 126 adults with moderate to severe acne who will be treated with amylose PDT or placebo. The efficacy of amylose PDT will be tested with the incubation durations of one and three hours compared with placebo. The primary endpoint is the change in number of inflammatory lesions and improvement in symptoms as assessed by the physicians conducting the study. The second study will evaluate the safety and tolerability of amyloids in the treatment of AK located on the face and scalp with PDT together with our new larger roto-led XL lamp. That study will enroll 100 patients with mild to severe AKs. Each patient will receive the content of three tubes of amyloids, for a field-directed treatment. This study follows a maximal usage pharmacokinetic study completed in early 2021. As we announced in June, the results of the PK study were presented to the FDA. In that meeting, the FDA requested another safety study focusing on transient application site effects before allowing the amendment of the product information to be changed to three tubes per treatment. Currently, the product information limits the use to one tube of amylose per treatment. Both studies are focused on optimizing market positioning and expanding market share for amylose. Both studies have commenced with site initiations underway. We expect patient recruitment to begin before the end of the year. In addition, we have an ongoing Phase III study in the United States to evaluate amylose in combination with PDT for the treatment of superficial basal cell carcinoma. We look forward to these studies concluding. And with that, I would like to conclude our business update. Thank you to our shareholders and to all who are taking the time to participate in this conference call. I would like to now open the line to questions.
spk03: We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. While we assemble our roster, please let me pass the call to Erica Monaco for some remarks.
spk02: Thanks, Matt. While we're waiting for the first question, I would just like to mention that as we establish our authority in the medical dermatology community, we look forward to our clinical trial results being published and expanding our market presence through supporting medical conferences and meeting with physicians and investors alike. This coming January, BioFrontera will be participating at both the Winter Clinical Dermatology Conference and the Maui Derm for Dermatologists Conference, both in-person meetings in Hawaii. We look forward to announcing more news about our participation there as we get closer to these conferences. Thank you. Okay, so thanks, Matt. I'm ready for the questions now.
spk03: Thank you. Our first question will come from Bruce Jackson with the Benchmark Company. Please go ahead.
spk04: Hi, good afternoon, and thanks for taking my questions. If you could just start off with maybe a housekeeping question on the share count. So after the IPO, we started 11.6. Can you tell us... What the base number of shares are right now, and then how many warrants are still outstanding?
spk02: So, settled as of, we're still in the mix of settling, but it should be somewhere around 12.245, I believe. There's still a bit of activity swirling today that we're not sure if it has settled.
spk04: Okay. And then, do you have a rough number for the outstanding number of warrants?
spk02: We don't have that readily available. As I said, there have been a handful coming in live, so we can certainly get that to you.
spk04: Okay. And so, you mentioned in the press release that the share of Biofronter AG is going to be around 52%, 53%, something like that in the press release.
spk07: We think that... with some of the loans now exercised, this is a moving target. And right now we, the question is of course, does it go below 50% and we don't know that yet.
spk04: Okay, fair enough. And then just to wrap up with the litigation expenses, is that all of litigation expense that's going to be in the BioFrontier income statement, or is there anything left to recognize in the future?
spk02: That is everything.
spk04: Okay, perfect. All right. I'll hop back in queue.
spk03: Again, if you have a question, please press star then one. Our next question will come from Jonathan Ashoff with Ross Capital Partners. Please go ahead.
spk05: Thank you. Hello and congrats, guys, on the spin-out and the severe balance sheet fortification. Can you tell us some specifics, as specific as you're willing to get, about what you plan to do and spend to increase the sales effort from now to maybe year-end?
spk07: We cannot hear you. We heard you well when you started, and then you sort of disappeared.
spk05: Okay. Can you hear me now?
spk07: Yes.
spk05: Okay, so can you tell me some specifics, to whatever extent you can, about what you plan to do and how much you plan to spend to increase the sales effort in the U.S. from here, let's say, to the end of next year?
spk02: Sure. I don't know how specific I can be because it is sort of a moving target based on the timing of the funds coming in. So we're definitely looking to expand the sales force. We're at 32 heads right now, and over time we want to get that above 50. I don't know if we will expand as rapidly. Perhaps mid-year next year we will see a good chunk of that eaten away at. The idea is to demonstrate rapid growth and expansion, but the timing – should be structured such that it doesn't impact our ongoing operations.
spk05: Okay. And can you say much about the BCC trial timing or is the trial design just very, very difficult to make predictions with?
spk07: The trial design is certainly a very difficult trial design because the FDA has requested the entire region of the skin where the BCC was to be dissected and then sliced up and looked at by histology. So that leaves the patient with a scar. And so it's difficult to find patients who want to go through the process and then they have a scar anyway. This is why recruitment has been slow. We started patient recruitment, the first patient in, I think, in the end of 2018. So we are already three years into the study. But we do think that we'll be completing patient recruitment next year.
spk05: Okay, that's helpful. So guys, as per my model, I have your pro forma cash that I have at about $36.7 million. That's the warrants, the private, as well as the IPO and the little bit you had at the end of the quarter. I mean, I've got that going much longer than 2022. So what am I missing? Is, you know, at least the next 12 months just a lawyer statement, or does it actually have any bearing to how long that cash might last?
spk02: Say that again. What's the specific question about the lawyer statement?
spk05: I'm just saying to say, you know, it lasts at least the next 12 months. Is that just some boilerplate, you know, legal statement, or you know, do you clearly have cash that's going to last substantially more than the next 12 months?
spk02: Yeah, with the pipe investment that's settled that we announced yesterday and the warrants that have been exercised, we have enough funds to last the next 12 months. That's not a boilerplate.
spk05: Okay, so you would anticipate on spending the cash on hand, that roughly, you know, $36-some-odd million over the next 12 months?
spk02: So I don't know that we... As I said, this is a moving target. Our ultimate goal is to grow the business as rapidly as possible, but with a balancing act to make sure that our operating funds are sufficient. So the growth strategy needs to be able to be supported by the funds. So the timing of that, I don't want to commit to any specifics.
spk05: Okay. And, well, that is it. Thank you very much.
spk03: Our next question is a follow-up from Bruce Jackson with The Benchmark Company. Please go ahead.
spk04: Hi. Thanks for the follow-up. I wanted to talk about the sales force just a little bit more. So once you get the new people hired, how long does it take for them to become seasoned and fully productive?
spk02: Yes, that's a good question, actually. You know, at a minimum, it takes extensive training over a couple of months. We like to have somebody fully functioning by the six-month mark. But to become a fully saturated rep in the marketplace, I think we're still learning that as we grow the business, as we really don't know the answer of what the true potential is of a fully seasoned rep. So we hope to grow not only our new reps to a certain level, but our existing reps as well.
spk04: Okay. Okay. And then so as we're looking ahead to 2022, then in terms of putting together the way that sales might ramp, should we be assuming that things start out on kind of the current growth trajectory, and then as the new salespeople get added in, then we could see some acceleration at some point after that?
spk02: I think that's a fair question. I would say yes. We have a really nice strategy to focus on our existing customer base plus expansion into the cryotherapy space, as we discussed. So in terms of growth, it's not as critical that our people are trained. It's more critical that our strategy is aligned and how we target them with our existing sales force versus our new should be similar. So I would think the growth will be a little bit more linear than you're thinking.
spk04: Okay. Okay, great. Thank you very much.
spk03: Our next question will come from Thomas Clayton with Lake Street Capital Markets. Please go ahead.
spk06: Hey, guys. Thanks for taking the question. Just I was curious, given that BioFrontier AG is charged with the clinical development, what obligations do you have under your – continue to fulfill those obligations, or do they have the power to pull the plug on any of those development projects at their discretion, or is there some joint operating committee that runs those?
spk02: So I'll let Herman comment as well, since he's here and can speak for both. But they are obligated to fulfill under the license and supply agreement because there is a beneficial need for our future success here. And if they are to not produce under our expectations for this, we do have rights within the agreement to come in and take control of either relationships or processes as needed to ensure that these continue on.
spk07: So if they don't, if they discontinue the clinical trials or don't start them, then BioFrontera Inc. can actually take over through the clinical trials and then simply subtract all the cost that BioFrontera Inc. has because of those trials from the transfer price for amylose.
spk06: Great. And then just a mechanical question. So the legal settlement announcement came out this week but you posted the charge for September 30th. Can you just explain the timing of the settlement and the accounting around that?
spk02: Sure, yeah. So the settlement took place yesterday morning, but because we had not yet filed our Q3 earnings, and this was a now known probable estimatable number, we needed to book it as a contingency at September 30th. So that was just an accounting rule and requirement, but the settlement did take place yesterday. Okay.
spk06: Great. Appreciate it. Thank you, guys.
spk03: This concludes our question and answer session. I would like to turn the conference back over to management for any closing remarks.
spk02: Thank you, Matt. And thank you again, everyone, for joining us this afternoon for our first quarterly conference call as a publicly traded U.S. company. I trust that we've shared our enthusiasm for the future of our product portfolio and BioFrontier's position within the dermatology community. We look forward to speaking with you all again when we report our annual results in March. In the meantime, thank you and have a nice evening.
spk07: Thank you also.
spk03: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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