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Biofrontera Inc. (BFRI)

Q3 2025 Earnings Call· Thu, Nov 13, 2025

$1.12

-0.88%

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Transcript

Operator

Operator

Welcome to the Biofrontera Inc. Third Quarter 2025 Financial Results and Business Update Conference Call. [Operator Instructions]. Please note, this event is being recorded. I would now like to turn the conference over to Ben Shamsian with Lytham Partners Investor Relations. Please go ahead.

Ben Shamsian

Analyst

Thank you. Good morning, and welcome to Biofrontera Inc.'s Third 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 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 the live broadcast, November 13, 2025. Biofrontera undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of the 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 just issued yesterday. Please note, management will be referring -- will be referencing adjusted EBITDA, non-GAAP financial measure defined as net income or loss, excluding interest income and expense, income taxes, depreciation and amortization and certain other nonrecurring or noncash items. With that said, I would like to turn the call over to Hermann Luebbert, CEO, Chairman and Founder of Biofrontera. Hermann, please proceed.

Hermann Lubbert

Analyst

Yes. Thank you, Ben. And my thanks to everyone who is joining us this morning. Before I begin with my company update, I want to address our 2025 revenues until September 30. Our year-to-date revenues were approximately flat to the same period in 2024. This is a wonderful achievement as we have offered few buying opportunities in 2025, and we did not have the equivalent price increase that we had on October 1, 2024. A price increase presents buy-in opportunities to customers and lacking these opportunities, our revenues in the third quarter of this year were 22% lower than in Q3 last year. However, this is a transient effect, which has begun to normalize in recent weeks. And as a result, we anticipate strong revenue growth in the fourth quarter in 2025 and consequently throughout 2025. We remain on track to achieve our full year sales objectives. Fred Leffler, our CFO, will discuss the numbers in a few minutes in much more detail. Now with that said, I would like to focus on our recent achievements and upcoming catalysts for revenue and profitability growth. We continue to make great progress in advancing Biofrontera as a premier dermatology company. Our revamped sales approach centered on refined customer segmentation and more focused commercial strategy and data-driven sales execution has proven effective as shown by the stable revenues without the booster of a price increase. Both physicians and patients gain a deeper understanding of Ameluz PDT's clinical value and efficacy. The installed base of RhodoLED lamps continues to expand, supporting recurring high-margin sales of Ameluz gel for years to come. For those new to Biofrontera, the Ameluz PDT treatment currently has indication only for the treatment of actinic keratoses or AK on the face and scalp. AKs are precancerous skin lesions, which may…

Eugene Leffler

Analyst

Thank you, Hermann, and it's great to be talking with everyone again. I'll start with our results for the 3 months ended September 30, 2025. Total revenues for the third quarter of 2025 were $7.0 million compared with $9.0 million for the third quarter of 2024. The 22% year-over-year sales decline in the third quarter reflects the temporary comparison effect as customers advanced purchases in the third quarter of 2024 ahead of the company's price increase that took effect on October 1, 2024. Total operating expenses were $13.3 million for the third quarter of 2025 compared with $14.0 million for the third quarter of 2024. Cost of revenues decreased by $2.8 million or 58% as compared to the 3 months ended September 30, 2024. This was primarily due to the reduced costs agreed upon with Biofrontera AG in relation to taking over clinical trial and other costs. Selling, general and administrative expenses were $10.4 million for the third quarter of 2025 compared with $8.4 million for the third quarter of 2024. The increase was primarily driven by increased legal costs due to patent claims, partially offset by $0.5 million in personnel savings, within both the direct sales team and the general administrative and administrative staff and a $0.3 million decrease in other miscellaneous general and administrative expenses. The net loss for the third quarter of 2025 was $6.6 million, compared to a net loss of $5.7 million for the prior year quarter. This increase in net loss is attributed to the higher legal costs, offset by a better gross margin. Adjusted EBITDA for the third quarter of 2025 was negative $6.0 million compared with negative $4.6 million for the third quarter of 2024. We look at our adjusted EBITDA and non-GAAP financial measure as a better indication of ongoing operations,…

Operator

Operator

[Operator Instructions]. And your first question today will come from Bruce Jackson with the Benchmark Company.

Bruce Jackson

Analyst

First, I wanted to ask, are you contemplating any price increases in the future? And if so, when?

Hermann Lubbert

Analyst

Yes, we are contemplating a price increase, and we are planning this before year-end.

Bruce Jackson

Analyst

Okay. And then a couple of additional questions on the new product pipeline. So you've completed enrollment in the trial for AK of the extremities. When do you think the data will be available? And what is the plan for submitting the data to the FDA?

Hermann Lubbert

Analyst

I think the data will be available probably in January. And to submit to the FDA, we are waiting for the results of a maximal-use pharmacokinetic study, which is [indiscernible] and we expect the results of that one about a month later than from the pivotal trial, so in February. So by the end of February, we should have everything that we need. And then putting all of that together into the dossier and fixing it all up for FDA submission will take some time. So we think that we'll be able to submit this to the FDA in Q2.

Bruce Jackson

Analyst

Okay. Okay. And then the -- a similar question for the acne trial. When will we see some data? And then what is the next step for that program from a regulatory standpoint?

Hermann Lubbert

Analyst

Well, the next step after that, so data will be pretty much in parallel with the data in the periphery, so also early next year. The next step then will be an end of Phase II meeting with the FDA. And then based on that, at the end of Phase II meeting and based on how the FDA positions themselves, we will plan the Phase III studies.

Bruce Jackson

Analyst

Okay. Okay. Got it. And then last question for me on the plan for breaking even. Should we think of it similar to the seasonality that we see on the income statement where the individual quarters in 2026 might bounce around between losses and gains and then the fourth quarter will be fairly large, resulting in a breakeven profit situation for the full year. So how we should be modeling that?

Eugene Leffler

Analyst

Bruce, yes, it's Fred here. Yes, that's exactly right.

Operator

Operator

This concludes our question-and-answer session. I would like to turn the conference back over to Hermann Luebbert for any closing remarks.

Hermann Lubbert

Analyst

Yes. Thank you for the questions, and thanks, everybody, again, to all our shareholders and to the health care professionals and especially the patients that we are proud to serve, to help the company progress, and thank you for your time this morning and your interest in the company. Thank you.

Operator

Operator

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