Biofrontera Q2 2025 Earnings Call Transcript

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August 14, 2025

Key Takeaways

  • Positive Sentiment: Biofrontera reported record-breaking commercial performance in H1 2025, selling over 50,000 tubes of Ameluz and placing 40 new RhodoLED XL lamps—bringing total U.S. installations to more than 700.
  • Positive Sentiment: The company completed its U.S. restructuring with Biofrontera AG, transferring all U.S. rights and moving from a 25–35% transfer price to a 12–15% royalty model, which is expected to significantly lower cost of sales and boost future margins.
  • Neutral Sentiment: Second-quarter revenues rose 15% year-over-year to $9.0 million—driven by a 5% price increase and 9.5% higher unit volume—while cost of goods sold fell 42%, though the net loss widened to $5.3 million due to non-cash warrant adjustments.
  • Positive Sentiment: Clinical pipeline advanced with Phase III enrollment complete for expanded actinic keratosis indications, a pending FDA submission in 2H 2025 for superficial basal cell carcinoma, Phase II acne data readout planned for Q4, and a patent extension to December 2043.
  • Negative Sentiment: Selling, general & administrative expenses increased to $10.5 million in Q2—primarily due to a $3.4 million spike in patent-defense legal costs—though management expects SG&A to normalize in subsequent quarters.
AI Generated. May Contain Errors.
Earnings Conference Call
Biofrontera Q2 2025
00:00 / 00:00

There are 6 speakers on the call.

Operator

Good day, and welcome to the Biofrontera, Inc. Second Quarter twenty twenty five Financial Results and Business Update Conference Call. Today, all participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note that today's event is being recorded.

Operator

I would now like to turn the conference over to Andrew Barwicki, Investor Relations. Please go ahead, sir.

Speaker 1

Thank you. Good morning, welcome to Biofrontera Incorporated's second quarter fiscal year twenty twenty five 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 press releases and SEC filings.

Speaker 1

Also, this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, which is 08/14/2025. 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.

Speaker 1

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 non recurring or non cash items. With that said, I would like now to turn the call over to Herman Loubert, CEO, Chairman and Founder of Biofrontera.

Speaker 2

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 2025. I am here with Fred Loeffler, our CFO, and will let Fred discuss the numbers in a few minutes, while I focus on the actual business and the things contributed to those numbers and our future. First and foremost, two 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.

Speaker 2

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 ROGOLET XL lamps were placed at physician offices during the 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.

Speaker 2

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.

Speaker 2

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.

Speaker 2

Along with organizing manufacturing on our own, the previous transfer price for Ameluz, which was 25% to 35% of our sales depending on year end indication, was replaced by a 12% royalty in years where Ameluz sales were less than EUR65 million and fifteen percent above. Already last year, when we took our clinical trial over clinical trial responsibility on 06/01/2024, we negotiated a reduced transfer price reflected in the cost of revenue for the first six months, which were about €2,600,000 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 $11,000,000 By now, Ameluz in combination with photodynamic therapy using our RhodoLED lamps is a proven and highly effective way of treating 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.

Speaker 2

As we look to the future, as of July, CMS has officially listed Ameluz in its MUE files for the use of up to three tubes, which is six hundred units per treatment. This follows a change in the patient information of Ameluz, which the FDA has approved in the 2024. Doctors can now rely on officially being reimbursed for the use of up to three tubes per treatment, which will be important for the treatments 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 a Phase three study to demonstrate the efficacy and safety of Ameluz for treating actinic keratosis on the trunk, neck and extremities.

Speaker 2

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 one year follow-up data that the FDA has requested for this tumor indication. We expect this to offer a non invasive treatment option for with high efficacy and very positive cosmetic outcomes, which could benefit many patients.

Speaker 2

Up to now, no PDT drug has been approved in The U. S. For the treatment of a 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.

Speaker 2

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 their 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.

Speaker 2

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, Roseland Advisors and Ag Capital Management for their leading role in the $11,000,000 investment, which allowed us to fund the restructuring of our relationship with Biofrontera AG.

Speaker 2

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?

Speaker 3

Thank you, Herman. It's great to be talking with everyone again. Let me first start with our second quarter results. Total revenues for the 2025 were $9,000,000 compared with $7,800,000 for the 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 2025.

Speaker 3

The higher volume the higher sales volume of Ameluz was due to improvements in direct sales team efficiency. Total operating expenses were $14,100,000 for the 2025 compared with $12,900,000 for the 2024. Cost of revenues decreased by $1,700,000 or about 42% as compared to the three months ended 06/30/2024. This was primarily due to the reduced Ameluz costs agreed to upon or in with Biofrontera in February 2024 in relation to us taking over the clinical trial costs last June. Selling, general and administrative expenses were $10,500,000 for the 2025 compared with $7,900,000 for the 2024.

Speaker 3

The increase was primarily driven by a $3,400,000 increase in legal costs due to patent claims, partially offset by $500,000 in personnel savings within both the direct sales team and general administrative staff and a $300,000 decrease in other general and admin expenses. The net loss for the 2025 was $5,300,000 compared with a net loss of $300,000 for the prior year quarter. The increase in the net loss is attributed to the non cash fluctuation in the change in fair value of warrants of $5,400,000 in 2024. Adjusted EBITDA for the 2025 was negative $5,100,000 compared with negative $4,700,000 for the 2024, reflecting higher SG and 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 non recurring or non cash items.

Speaker 3

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 2025. Total revenues were $17,600,000 for the 2025 compared with $15,800,000 for the 2024. This 12% increase was driven by higher sales price contributing $600,000 and increased sales volume of Ameluz contributing $1,000,000 as well as about $300,000 increase in the sales of the RotoLED 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 Herman mentioned earlier.

Speaker 3

Total operating expenses were $27,200,000 for the 2025 compared with $26,300,000 for the 2024. Increased legal expenses were offset by reduced operational costs. Cost of revenue decreased from the prior year to $5,500,000 for the 2025 compared to $8,000,000 for the 2024 due to the reduced transfer price agreed upon with Biofrontera AG in February 2024 in relation to the clinical taking over clinical development costs I mentioned earlier. Selling, general and administration expenses increased to $19,200,000 compared to $17,200,000 in the prior The increase was primarily attributable to a $4,400,000 increase in legal expenses driven by patent claim related legal costs. The increased legal expenses were partially offset by savings in personnel of 900,000.0 due to headcount fluctuations at our commercial team and administrative teams as well as a decrease of 500,000.0 in expenses relating to sales support functions and a decrease of about $400,000 in issuance costs.

Speaker 3

Looking at R and D, we have spent $2,100,000 during the 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 $3,500,000 Adjusted EBITDA for the first half of the year was negative $900,000 compared with negative $9,300,000 for the 2024. Again, please refer to the table in our news release for a reconciliation of these financial measures. Turning to our balance sheet.

Speaker 3

As of 06/30/2025, we had cash and cash equivalents of $7,200,000 compared with $6,000,000 as of 12/31/2024. This is driven by both the growth in sales and 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.

Speaker 3

This puts us in a better operational and financial position, especially when it comes to inventory levels and working capital, add to which the restructuring deal will allow us to better address impacts from any potential tariffs in the future. As we announced in the past and Herman mentioned a few moments ago, the support of an $11,000,000 investment has enabled us to get to this point. I want to thank again the folks at Braselin Advisors and AIGH Capital for working with us, the financial commitment 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 pending shareholder approval. With that overview of our business and recent financial performance, Herman and I are now ready to take questions from

Operator

And today's first question comes from Jonathan Aschaw with ROTH Capital Partners. Please proceed.

Speaker 4

Hi, good morning guys. Thank you. It's just a few questions. How many of each lamp were placed in 2Q twenty twenty five?

Speaker 3

We placed 18 XL in twenty twenty five. Hermione, you have the RotoLED, I didn't memorize that one.

Speaker 4

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

Speaker 3

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

Operator

Okay.

Speaker 4

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

Speaker 2

Correct. And that would be U. S. This year.

Speaker 4

How many hold on. How many XL this year?

Speaker 2

40 XL lamps in the 2025.

Speaker 4

40, not 18. And so where did that 18 come from, Fred?

Speaker 3

I thought you said for Q2. So 2022 in Q1 and then 18 in Q2.

Speaker 4

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

Speaker 3

I'll look, yes, I'll get that.

Speaker 4

Okay. When do you think you'll receive the $2,500,000 Is that still a third quarter twenty twenty five event?

Speaker 3

Yes, that's correct.

Speaker 4

Okay. Is the data timing still as it was last reported, meaning acne in 4Q twenty twenty five? 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 AK, I'm sorry?

Speaker 2

Yes, also in the fourth quarter.

Speaker 4

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

Speaker 2

We don't expect to do this year.

Speaker 4

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 on Ameluz?

Speaker 2

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

Speaker 4

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

Speaker 2

Probably our part of the market is roughly about a third.

Speaker 4

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

Speaker 2

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

Speaker 4

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

Speaker 2

It's what can be Well, for them, it would be 80%. For us, it's 100%

Speaker 4

almost. Right. Okay. Okay, great. 80% head and scalp for Levulan.

Speaker 4

Can we assume that the higher 02/2025 SG and A spend is more predictive of future quarterly SG and A than the lower first quarter amount?

Speaker 3

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

Speaker 4

That's good news. That's all I had. Thanks for answering them.

Operator

The next question is from Bruce Jackson with The Benchmark Company. Please proceed.

Speaker 5

Hi, good morning and thank you for taking my questions. 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?

Speaker 3

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

Speaker 5

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?

Speaker 3

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 burned that off through the 2024 and a little bit slipped into 2025.

Speaker 3

Once we got to the 25% transfer price product, that's what's driving everything year to date. 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 and then plus a little bit for the two versus the 25% to 35% that Herman mentioned.

Speaker 5

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

Speaker 3

No. So our well, it's just I would say 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.

Speaker 5

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.

Speaker 3

The

Speaker 5

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?

Speaker 3

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

Speaker 5

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.

Speaker 2

No, we didn't talk about that. So the FDA submission is currently being prepared. It requires a pooled analysis of safety between the European PCC study and The U. S. Study, which is now completed.

Speaker 2

And so everything is now being put together for FDA submission, which will come sometime in the second half of this year.

Speaker 5

Okay, great. That's it for me. Thank you.

Speaker 3

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

Operator

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

Speaker 2

Yes. Thank you all. First, the analysts for the questions and everybody else for taking the time and being here. We had two very encouraging quarters. And I can't say how excited I am to see the results of the second half of this year.

Speaker 2

So thank you very much and have a nice day.

Operator

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

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