Biofrontera Inc. (BFRI) Q2 2025 Earnings Report, Transcript and Summary

Good day, and welcome to the Biofrontera Inc. Second Quarter 2025 Financial Results and Business Update Conference Call. [Operator Instructions] Please note that today's event is being recorded. I would now like to turn the conference over to Andrew Barwicki, investor Relations. Please go ahead, sir.

Thank you. Good morning, and welcome to Biofrontera Incorporated Second Quarter Fiscal Year 2025 Financial Results and Business Update Conference Call. Please note that certain information discussed during today's call by management 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 the 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. Also, this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, which is August 14, 2025. Biofrontera undertakes no obligation to revise or update any forward-looking statements or reflect events -- to reflect events or circumstances after the date of this conference call, except as required by law. During today's call, there will be references 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 the press release we issued. Please note, management will be referencing adjusted EBITDA, a non-GAAP financial measure defined as net income or loss excluding interest income and expenses, income taxes, depreciation and amortization, and certain other nonrecurring or noncash items. With that said, I would like now to turn the call over to Hermann Luebbert, CEO, Chairman and Founder of Biofrontera.

Thank you, Andrew, and thank you to everyone joining us this morning. I'm very pleased to share that Biofrontera has delivered record breaking results this quarter and throughout the first half of 2025. I am here with Fred Leffler, our CFO, and will let Fred discuss the numbers in a few minutes, while I focus on the actual business and the things that contributed to those numbers and our future. First and foremost, 2 very gratifying quarters were driven by the changes in our approach to our business in 2025, which turned out to be successful. And for the first time, we sold more than 50,000 tubes of Ameluz in the first half of the year. We transformed our customer segmentation, focused our strategy and used more extensive data analysis to support our sales team effectively. Furthermore, we have changed the hiring approach for our sales team, giving attitudinal factors and emotional intelligence priority over dermatology experience. I'm also pleased to say that 40 RhodoLED XL lamps were placed at physician offices during the first half of 2025. These include installations at facilities that we have been -- not been in before as well as locations throughout the United States that now have multiple lamps in one office. As I have said many times in the past, lamp placements are the leading indicator for future growth, and we now have more than 700 out in doctors' offices. It is clear that dermatologists are seeing the promising and viable results as they are prescribing Ameluz for more and more patients. The transformational change for our commercial basis was the major restructuring of our relationship with Biofrontera AG by which Biofrontera Inc. becomes completely independent of Biofrontera AG. The agreement includes the transfer of all rights and obligations for the U.S. market for Ameluz and the RhodoLED lamp series to Biofrontera Inc. We are in the process of transferring all U.S. IP, the FDA approvals and the contracts with third-party manufacturers as well as the internal lamp manufacturing. Completing this will take a while as some of these functions require agency registrations, but the financial consequences are already in place. Along with organizing manufacturing on our own, the previous transfer price for Ameluz, which was 25% to 35% of our sales depending on year and indication, was replaced by a 12% royalty in years where Ameluz sales were less than $65 million and 15% above. Already last year, when we took our clinical trial -- over clinical trial responsibility on June 1, 2024, we negotiated a reduced transfer price reflected in the cost of revenue for the first 6 months which were about $2.6 million lower than in the previous year, mostly due to the reduced transfer price. Shifting to the royalty model now will only -- not only dramatically decrease our cost of sales further, but also significantly delay the time of the payments. The importance of this for our future was recognized by our investors who financed this transformation with the required $11 million. By now, Ameluz in combination with photodynamic therapy using our RhodoLED lamps is a proven and highly effective way of actinic keratosis of mild to moderate severity on the face and scalp. This is our driving force and one that we are so proud of as we run our day-to-day operations. As we look to the future, as of July 1 this year, CMS has officially listed Ameluz in its MUE files for the use of up to 3 tubes, which is 600 units per treatment. This follows a change in the patient information of Ameluz, which the FDA has approved in the fall of 2024. Doctors can now rely on officially being reimbursed for the use of up to 3 tubes per treatment, which will be important for the treatment of AK on face and scalp, but even more for treatments of AK on other larger sites on the rest of the body. Such treatments are outside of our approved indication so far. However, during this reporting period, we have completed enrollment in the Phase III study to demonstrate the efficacy and safety of Ameluz for treating actinic keratosis on the trunk, neck and extremities. Once the results become available, we plan to submit them to the FDA to expand our label and allow doctors to treat AK on the entire body. In parallel, we aim to include new indications into our label. The first one is going to be superficial basal cell carcinoma. Our Phase III trial for this indication is completed, including the 1-year follow-up data that the FDA has requested for this tumor indication. We expect this to offer a noninvasive treatment option for -- with high efficacy and very positive cosmetic outcomes, which could benefit many patients. Up to now, no PDT drug has been approved in the U.S. for the treatment of the tumor disease. Currently, Ameluz is also only indicated to treat precancerous skin lesions, which may progress to invasive skin cancers, and extending this to treating potentially infiltrating tumors is an exciting development, both scientifically and commercially. We are also very encouraged about the potential for Ameluz to be effective -- an effective treatment for acne vulgaris. Acne is a chronic inflammatory skin condition affecting the pilosebaceous unit, which results from a combination of factors. While it's a very common condition during adolescence, it is becoming increasingly common in adults and can persist even into the 40s and 50s. We believe from the data we see so far that Ameluz has the potential to effectively treat this affliction as well. In the reporting period, we have been able to complete patient enrollment in a Phase II trial, treating moderate to severe acne, and we are now waiting for the last patient to finish that treatment for us to be able to analyze the data. Earlier this year, we received patent approval for the new improved formulation of Ameluz, extending patent protection of the drug through December 2043. Biofrontera is the only company organizing FDA controlled clinical studies for PDT in dermatology in the U.S. And the extended patent life is relevant to recover the investment and profit from the resulting possibilities. I would like to thank our entire team for their continued dedication to execution and growth, which has enabled us to deliver the strong results Fred will now talk about. I also want to thank our shareholders for their confidence, in particular, Rosalind Advisors and A Capital Management for the leading role in the $11 million investment, which allowed us to fund the restructuring of our relationship with Biofrontera AG. At this time, I am pleased to turn the call over to Fred to go through the financial details of the second quarter and first half. Fred?

Thank you, Hermann. It's great to be talking with everyone again. Let me first start with our second quarter results. Total revenues for the second quarter of 2025 were $9.0 million compared with $7.8 million for the second quarter of 2024. This increase was driven by both a 5% higher unit sale price and 9.5% increases in the sales volume of Ameluz in the second quarter of 2025. The higher volume -- the higher sales volume of Ameluz was due to improvements in direct sales team efficiency. Total operating expenses were $14.1 million for the second quarter of 2025 compared with $12.9 million for the second quarter of 2024. Cost of revenues decreased by $1.7 million or about 42% as compared to the 3 months ended June 30, 2024. This was primarily due to the reduced Ameluz costs agreed to upon -- or in -- with Biofrontera in February of 2024 in relation to us taking over the clinical trial costs last June. Selling, general and administrative expenses were $10.5 million for the second quarter of 2025 compared with $7.9 million for the second quarter of 2024. The increase was primarily driven by $3.4 million -- by a $3.4 million increase in legal costs due to patent claims, partially offset by $0.5 million in personnel savings within both the direct sales team and general and administrative staff, and a $0.3 million decrease in other general and admin expenses. The net loss for the second quarter of 2025 was $5.3 million compared with a net loss of $0.3 million for the prior year quarter. The increase in the net loss is attributed to the noncash fluctuation in the change in fair value of warrants of $5.4 million in 2024. Adjusted EBITDA for the second quarter of 2025 was negative $5.1 million compared with negative $4.7 million for the second quarter of 2024, reflecting the -- reflecting higher SG&A costs, offset by lower cost of goods sold. We look at adjusted EBITDA, a non-GAAP financial measure, as a better indication of ongoing operations. And this measurement is defined as net income or loss excluding interest income expense, income taxes, depreciation, amortization and certain other nonrecurring or noncash items. I'll refer you to the table in the news release we released yesterday for a reconciliation of these financial measures. Now I'll turn the attention to the first half of 2025. Total revenues were $17.6 million for the first half of 2025 compared with $15.8 million for the first half of 2024. This 12% increase was driven by higher unit sales price contributing $0.6 million and increased sales volume of Ameluz contributing $1 million, as well as about $0.3 million increase in the sales of the RhodoLED lamps. The higher sales volume of Ameluz was due to, again, continued improvements on the sales team efficacy and using data and some of the things Hermann mentioned earlier. Total operating expenses were $27.2 million for the first half of 2025 compared with $26.3 million for the first half of 2024. Increased legal expenses were offset by reduced operational costs. Cost of revenue decreased from the prior year to $5.5 million for the first 6 months of 2025 compared to $8.0 million for the first half of 2024 due to the reduced transfer price agreed upon with Biofrontera AG in February 2024 in relation to the clinical -- taking over clinical development cost I mentioned earlier. Selling, administration -- selling, general and administration expenses increased to $19.2 million compared to $17.2 million in the prior year. The increase was primarily attributable to a $4.4 million increase in legal expenses driven by patent claim related legal costs. The increased legal expenses were partially offset by savings in personnel of $0.9 million due to head count fluctuations in our commercial team and administrative teams as well as a decrease of $0.5 million in expenses relating to sales support functions and a decrease of about $0.4 million in issuance costs. Looking at R&D, we have spent $2.1 million during the first half of 2025 on our active clinical trials. We've been working efficiently on execution and spending is proceeding as planned. I would like to note that these costs have been more than offset by the reduced transfer price resulting in lower COGS of about $3.5 million. Adjusted EBITDA for the first half of the year was negative $0.9 million compared with negative $9.3 million for the first half of 2024. Again, please refer to the table in our news release for a reconciliation of these financial measures. Turning to our balance sheet. As of June 30, 2025, we had cash and cash equivalents of $7.2 million compared with $6.0 million as of December 31, 2024. This is driven by both the growth in sales and the capital raised -- the capital raise associated with our last transaction. We constantly monitor our inventories and communicate with our commercial team to ensure we have product availability to support our increasing sales. We are not carrying any excess inventory currently and are in a good spot. When we take over manufacturing of Ameluz, we will have better control of the entire process and a shorter lead time for the product. This puts us in a better operational and financial position especially when it comes to inventory levels and working capital, add to which the restructure -- the restructuring deal will allow us to better address impacts from any potential tariffs in the future. As we announced in the past, and Hermann mentioned a few moments ago, the support of an $11 million investment has enabled us to get to this point. I want to thank, again, the folks at Rosalind Advisors and AIGH Capital for working with us, the financial commitments and the support to expand our opportunities in making Ameluz and the lamps available for medical treatments. The first tranche is on our balance sheet as of June 30 as a liability and will be reclassed into mezzanine equity in July and finally, permanent equity after we hold our special shareholder meeting in September of this year, pending shareholder approval. So with that overview of our business and recent financial performance, Hermann and I are now ready to take questions from our covering analysts. Operator?

[Operator Instructions] And today's first question comes from Jonathan Aschoff with ROTH Capital Partners.

It's just a few questions. How many of each lamp were placed in 2Q '25?

The XL... Go ahead.

No, go ahead, Fred.

We placed 18 XLs in 2025. Hermann, if you have the RhodoLED, I didn't memorize that one.

Well, I have the first quarter, so I can just do the math. And how much of the small one, in what time period?

Sorry, Jonathan. That was, what I was saying, I don't have that one, the small one memorized, but I can get back to you on that.

Okay. But you said a total of about 700 lamps all told ever since you started, correct?

Correct. 50 XLs this year.

And that would be U.S. ND. How many -- hold on. How many XLs this year?

40 XL lamps in the first half of '25.

Okay. 40, not 18. And so where did that 18 million comes from, Fred?

I thought you said for Q2. So 22 in Q1 and then 18 in Q2.

Excellent. Excellent. That's totally good. And you don't have that data for the smaller lamp still, correct?

I don't, but yes, I'll get that. Hold on.

Okay. When do you think you'll receive the $2.5 million? Is that still a third quarter '25 event?

Yes, that's correct.

Okay. Is the data timing still as it was last reported, meaning acne in 4Q '25? And I never saw a data release timing for the peripheral AK. You have timing for pretty much everything else around it, but when do you think we'll see the data for that? So is acne still fourth quarter and when data for the peripheral LK-- AK, I am sorry?

Yes, also in the fourth quarter.

Okay. Also, both in the fourth quarter, great. Any 5% hikes for price coming soon, soon-ish like they did last year? I think it was October.

We don't expect to do this, this year.

Okay. Any change in the rate at which you are converting Levulan users to at least also use Ameluz? Basically, do they typically use both initially? Or do they abandon Levulan once you sell them Ameluz?

No, they typically use both initially, most use both, particularly since we don't have approval for the arms, which Levulan has. So -- and obviously, when we convert Levulan users and they start tying some Ameluz and then growing it from there.

What is the fraction of use -- where you're currently approved, what fraction of the overall use is that? Like I guess, really, you can only speak for Levulan. What fraction is their use where you are approved now versus all over?

Probably, our part of the market is roughly about 1/3...

But I'm saying just in Levulan alone, so you can do an apples-to-apples comparison, what fraction of overall Levulan use is just in the face and scalp where you're approved?

Oh, I see. So it's probably in the range of 20%. 20% is on the arms.

Arms. So how about just the face and scalp where you're approved?

Well, for them, it would be 80%, for us, it's 100% almost.

Right. Okay. Okay. Great. 80% head and scalp for Levulan. Can we assume that the higher 2 quarter '25 SG&A spend is more predictive of future quarterly SG&A than the lower first quarter amount?

I would not make that conclusion as we had -- we definitely had a spike in legal spend during Q2 with our patent claim defense.

And the next question is from Bruce Jackson with The Benchmark Company.

So with the gross margins in the quarter, we had a nice step up here. How do you see those unfolding over the next couple of quarters given the new agreement with Biofrontera AG?

Bruce, this is Fred. You broke up for me a little bit. Would you mind repeating that question, please?

Yes. So my question is, we've got the gross margins heading higher in the second quarter. What's going to happen going forward for the next couple of quarters?

Okay. I got you. Yes. So the gross margin did increase in Q2 because of the restructuring of the LSA agreement last year. So we had a decent amount of inventory that was under the old LSA structure. So we burnt that off through the end of 2024 and a little bit slipped into 2025. So once we got to the 25% transfer price product, that's what's driving everything year-to-date. Our -- so we are working with the manufacturers right now to get exact prices and things like that. But our cost of goods sold, and therefore, our gross profit should increase quite substantially as a result of this most recent transaction. We'll pay the 12% royalty, so -- and then plus a little bit for the 2 versus the 25% to 35% that Hermann mentioned.

Okay. Would you care to quantify the substantially bit of that?

So our -- well, it's just -- I would say it's to -- it's going to drop from 25%. Probably it will improve by 12%, 13% I would estimate. But we're still working through that, as I mentioned.

Okay. Okay. That's fine. And then I guess the one thing that was -- that's hard to get a handle on from a modeling standpoint is the legal expenses. They can be unpredictable. They could be lumpy. The timing is uncertain. Is -- can you give us just roughly a sense of like how long this might continue? And if there's going to be any ongoing impact here, at least for the next couple of quarters?

Yes. So the legal expenses, as I said, spiked in Q2. And so that should come down and be -- and our SG&A run rate should be much more in line with historical amounts Q3 and Q4.

Okay. And then last question for me is just on the FDA submission for the superficial basal carcinoma indication. Do you have any ideas around the timing for that? And I apologize if I missed that earlier.

No, really, we didn't talk about that. So the FDA submission is currently being prepared. It requires approved analysis of safety between the European BCC study and the U.S. study, which is now completed. And so everything is now being put together for FDA submission, which will come sometime in the second half of this year.

And Bruce, I'm going to answer Jonathan's question. So we shipped 9 small lamps year-to-date.

And this does conclude today's question-and-answer session. I would now like to turn the conference back over to, Hermann, for any closing remarks.

Yes. Thank you all, of course, the analysts for the questions and everybody else for taking the times and being here. We had 2 very encouraging quarters. And I can't say how excited I am to see the results of the second half of this year. So thank you very much and have a nice day.

The conference has now concluded. Thank you for attending today's presentation, and you may now disconnect.