Biofrontera Q3 2026 Earnings Results & Report

Biofrontera EPS Results

• Actual EPS: -$0.42
• Consensus EPS: -$0.11
• Beat/Miss: Missed by -$0.31
• One Year Ago EPS: N/A
• EPS Beat Rate: 4 of last 8 quarters

Biofrontera Revenue Results

• Actual Revenue: $9.07 million
• Expected Revenue: $8.50 million
• Beat/Miss: Beat by +$570.00 thousand
• YoY Revenue Growth: N/A

Biofrontera (NASDAQ:BFRI) (NASDAQ:BFRI) is a specialty pharmaceutical company focused on developing and commercializing prescription dermatology products, with an emphasis on treatments for precancerous and cancerous skin conditions. The company primarily serves the U.S. dermatology market through a commercial organization that supports physicians and other healthcare providers.

Biofrontera’s principal product is Ameluz (aminolevulinic acid hydrochloride) topical gel, a prescription medication used with photodynamic therapy to treat actinic keratoses. The treatment is administered in combination with the BF-RhodoLED or BF-RhodoLED XL photodynamic therapy lamp, which activates the medication on affected areas of the skin. Actinic keratoses are common sun-related lesions that can potentially develop into skin cancer.

Biofrontera Inc. was established as the U.S. operating company of German dermatology group Biofrontera AG and began trading on Nasdaq in 2021. Its activities are primarily concentrated in the United States, where it markets Ameluz and related photodynamic therapy systems to dermatology practices. The company’s business is centered on expanding adoption of its existing products and developing additional dermatology applications.

Biofrontera Q3 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: FDA approval of Ameluz for superficial basal cell carcinoma gives Biofrontera a second U.S. indication and a non-surgical treatment option using lamps already in dermatology offices. The company expects a full commercial launch in the first quarter of 2027.
• Positive Sentiment: U.S. Customs cleared the redesigned RhodoLED XL-C from the ITC exclusion order, and Biofrontera says remediation has reduced the share of Ameluz sales affected by the order from about 25% to 10%. The company expects field remediation to be substantially complete by the end of the second quarter of 2027, though appeals remain pending.
• Positive Sentiment: Third-quarter revenue rose 29.8% year over year to $9.1 million, with Ameluz tube volume up about 23%; gross margin improved to 74.4% from 70.7%. Management cautioned that much of the volume growth reflected orders brought forward ahead of the ITC order taking effect.
• Positive Sentiment: Biofrontera submitted an application to expand Ameluz use to actinic keratosis on the extremities, neck, and trunk, with an FDA decision date of August 5, 2027. The company says approval could extend treatment to larger body areas using its existing lamps and sales force.
• Negative Sentiment: The company reported $3.2 million in cash at quarter-end and disclosed substantial doubt about its ability to continue as a going concern for at least 12 months. Its mitigation plans include revenue growth, a working credit line, a conditional $1 million divestiture milestone, and potential additional capital; management said these plans have not alleviated the doubt, and the company does not currently meet Nasdaq’s minimum stockholders’ equity requirement.

Presentation

[Operator]

Welcome to the Biofrontera Inc. Third Quarter 2026 Financial Results and Business Update Conference Call. At this time, all participants are in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's prepared remarks, 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 Ben Shamsian with Lytham Partners Investor Relations. Please go ahead.

[Ben Shamsian, VP of Investor Relations at Lytham Partners]

Good morning, and welcome to Biofrontera's Third Quarter 2026 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 risks and uncertainties associated with the company's business.

[Ben Shamsian, VP of Investor Relations at Lytham Partners]

Forward-looking statements on today's call include statements regarding the timing and success of the commercial launch of Ameluz, of superficial basal cell carcinoma, the company's supplemental New Drug Application for actinic keratosis on the extremities, neck, and trunk, the effects of the International Trade Commission orders, the company's remediation plan, and the RhodoLED XL-C, the outcome of pending appeals and patents proceedings, the company's liquidity, its ability to continue as a going concern, and its plans to address that condition, and the company's compliance with Nasdaq continued listing standards.

[Ben Shamsian, VP of Investor Relations at Lytham Partners]

All risks and uncertainties are detailed in and are qualified by the cautionary statements contained in the Biofrontera's press releases and SEC filings, including the company's quarterly report on the Form 10-Q for the quarter ended September 30, 2026, which the company expects to file later today, and the company's annual report on the Form 10-K for the year ended December 31, 2025. Also, this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast. Biofrontera undertakes no obligation to revise or update any forward-looking statements 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.

[Ben Shamsian, VP of Investor Relations at Lytham Partners]

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 issued today and is available on the company's website at www.biofrontera-us.com under the Investor Relations section. Please note, management will be referencing Adjusted EBITDA, a non-GAAP financial measure defined as net loss excluding interest expense, net income taxes, depreciation and amortization, and certain other non-recurring or non-cash items, including changes in fair value of warrant liabilities and of the related party investment, patent remediation expense, and ITC-related inventory write-downs, and stock-based compensation. With that said, I would now like to turn the call over to Hermann Luebbert, CEO, Chairman, and Founder of Biofrontera. Hermann, please proceed.

[Operator]

Sir, is your line on mute perhaps?

[Hermann Luebbert, CEO, Chairman, and Founder at Biofrontera]

Yes, I was on mute. Thank you. Well, thanks, Ben, and thanks everyone for joining us this morning. Do you hear me now?

[Operator]

Yes, sir. Loud and clear.

[Hermann Luebbert, CEO, Chairman, and Founder at Biofrontera]

Great. The third quarter changed what the company is able to sell and to whom, with two things happening within five days of each other in September, and I want to start with both of them before we get to the numbers. On September 9, the FDA approved Ameluz photodynamic therapy for the treatment of superficial basal cell carcinoma in adults. That makes Ameluz the first PDT approved in the United States to treat a skin cancer. Until now, our label has been limited to mild to moderate actinic keratosis on the face and scalp. We now have a second indication. Superficial basal cell carcinoma represents up to 20% of all basal cell carcinomas, the most common cancers in the United States. Many of these patients are today treated surgically.

[Hermann Luebbert, CEO, Chairman, and Founder at Biofrontera]

Ameluz PDT gives dermatologists a non-surgical option with a favorable cosmetic outcome that they can deliver with the red lamp that is already in the office. Furthermore, we believe that the approval to treat a skin cancer will convince more doctors to introduce Ameluz PDT as a routine treatment in their offices and purchase one of our red lamps. On September 14, four days after the superficial BCC approval, U.S. Customs and Border Protection ruled that our redesigned large field lamp, which we called RhodoLED XL-C, does not infringe the asserted claims of the DUSA Pharmaceuticals patents and is not subject to the exclusion order issued by the International Trade Commission, or ITC, earlier in the year. Let me put that into context. The ITC orders took effect on July 6.

[Hermann Luebbert, CEO, Chairman, and Founder at Biofrontera]

From that date, we could not import or sell the original RhodoLED XL, and we could not sell Ameluz for use with it. Customers whose only lamp was the RhodoLED XL were temporarily unable to buy Ameluz from us. In light of the September 14 CBP ruling, we can now sell the RhodoLED XL-C, providing our prior RhodoLED XL customers with a large five-panel lamp that is unrelated to the ITC orders to go alongside our smaller BF-RhodoLED lamp, which is similarly not affected by the ITC orders. Of course, we can continue selling Ameluz to any customers who have either an XL-C or a BF-RhodoLED lamp. By September, the number of customers ordering from us was back to the level of a year ago.

[Hermann Luebbert, CEO, Chairman, and Founder at Biofrontera]

I said on our last call that we will not allow our commercial plan to depend on winning in court, and that is how it turned out. We designed around the patents, obtained the favorable ruling, had no objections from the FDA, and are working through the remediation of the affected lamps in the field, which we expect to be substantially complete by the end of the second quarter of 2027. We will furthermore file our appeals with the Federal Circuit, both of the commission's determination and of the Patent Office director's decision. I will not speculate on the timing or outcome of those appeals. This matter did cost us in the quarter. Fred will take you through the detail, but legal fees, remediation costs, and inventory write-downs tied to the ITC matter are the main reason our operating loss was larger than in the second quarter.

[Hermann Luebbert, CEO, Chairman, and Founder at Biofrontera]

I regard most of this as the cost of getting to the other side of the problem. Now to the pipeline, because it is the clearest picture of how this company grows in 2027 and beyond. First, superficial basal cell carcinoma. We expect to begin commercializing Ameluz for sBCC with a full launch in the first quarter of 2027 after receiving FDA feedback on our anticipated marketing material. The launch goes into our existing installed base of lamps and our existing dermatology call points. George will describe the preparation. Second, actinic keratosis on the extremities, neck, and trunk. In early October, we submitted our supplemental New Drug Application to expand the Ameluz label beyond the face and scalp to treat AK on the entire body. FDA has confirmed a PDUFA date of August 5, 2027, and initiated its preliminary review.

[Hermann Luebbert, CEO, Chairman, and Founder at Biofrontera]

AK is, in most cases, a UV light-induced disease and occurs on all body parts frequently exposed to the sun. Such body parts can be larger than face and scalp, and we applied for a treatment field of up to 240 cm², supported by the positive phase III results we announced earlier this year. As PDT on larger areas is often associated with more pain, we furthermore filed with FDA an illumination protocol expected to reduce this pain. With approximately 58 million American adults having at least one AK lesion, treating the extremities, neck, and trunk meaningfully expands the use of Ameluz in every one of our customers' offices and on every lamp already in the field. The picture is this. One year ago, we had one indication and a transfer price that took 25%-35% of our revenue away.

[Hermann Luebbert, CEO, Chairman, and Founder at Biofrontera]

Today, we own the U.S. assets, we have two approved indications, a third filed, and a lamp portfolio that is clear of the ITC exclusion order. Each of the indications runs through the same lamps and the same sales force. I would now like to turn the call over to George Jones, our Chief Commercial Officer. George?

[George Jones, Chief Commercial Officer at Biofrontera]

Thank you, Hermann, and good morning, everybody. Product revenues in the third quarter were $9.1 million, an increase of approximately 30% year-over-year. Ameluz unit volume grew approximately 23%, with the balance of the growth coming from a price increase we implemented in the fourth quarter of 2025, as well as increased lamp sales that occurred during the quarter. In the third quarter, we sold approximately 25,120 tubes of Ameluz, up 23% from 20,380 in Q3 of 2025. I'd like to drill a little deeper into the results. In June into early July, ahead of the ITC orders taking effect, a number of customers purchased Ameluz earlier than they otherwise would have. Because of those purchases, we had a fast start to the quarter. We ensured customers received ample supply of Ameluz to treat their patients while we worked on the remediation efforts Hermann spoke about earlier.

[George Jones, Chief Commercial Officer at Biofrontera]

This higher July was simply a shift in timing, and we believe that this inventory was largely worked through by the end of Q3. It is important to remember that the ITC orders only impacted approximately 200 customers and 25% of our Ameluz sales volume, and the rest of our customers could continue to purchase Ameluz as normal. Moving on to lamps, we ended the quarter with an installed base of 853 lamps across 742 different dermatology offices. This includes approximately 12 of the smaller RhodoLED lamps that were sold during Q3 to customers that wanted a Biofrontera red light, but didn't want to wait until the XL-C was available. This is good news. We began processing exchanges of the XL-C lamps upon receiving US Customs and Border Protection approval. They began shipping during Q3, but were not installed until early October.

[George Jones, Chief Commercial Officer at Biofrontera]

As I think back on the quarter, I'm especially pleased by the progress we made on the remediation efforts Hermann mentioned. By placing both RhodoLED and XL-C lamps in offices that previously purchased the XL lamps, we have been able to significantly reduce the percentage of Ameluz sales impacted by the ITC order from approximately 25% of Ameluz volume to only 10% of Ameluz sales volume today. Turning to sales execution, I could not be more impressed with this Biofrontera team. They've never met a challenge that they haven't been able to overcome. We're seeing significant momentum in our business. All key sales metrics were positive year-over-year, both in Q3 as well as the first nine months of the year.

[George Jones, Chief Commercial Officer at Biofrontera]

In Q3, orders were up 6% year-over-year, tubes per order were up 21%, and new locations buying Ameluz increased by 11, or 39% year-over-year. Looking at 2026 to date, tubes of Ameluz were up 23%, number of orders were up 13%, and tubes per order were up 10% year-over-year. Furthermore, in 2026, we've seen lower turnover within our sales force, as well as a positive impact of our new inside sales efforts, which is contributing to our overall results. Moving on to sBCC and launch preparation, I'd like to start by saying there's been significant early interest in learning more about Ameluz for superficial basal cell carcinoma, and a clear belief from our customers that this new indication provides meaningful differentiation between Ameluz red light PDT and our competitors.

[George Jones, Chief Commercial Officer at Biofrontera]

As we mentioned earlier, we're launching using a phased approach for which phase one is underway. I'd like to call out some phase one highlights for you. We've begun talking to KOLs about the sBCC data and received great feedback. We've confirmed our reimbursement strategy. As Hermann mentioned, we've submitted our marketing claims to the FDA for their feedback. Our full product training is beginning this week, and our launch meeting is scheduled for mid-January. Importantly, to support the launch, I want to reiterate that we'll be using our current sales infrastructure and calling on many of the same dermatology offices who are already equipped and ready to expand their utilization and offer their patients an innovative non-surgical option to treat their superficial basal cell carcinoma. We are looking forward to the fourth quarter and finishing 2026 strong.

[George Jones, Chief Commercial Officer at Biofrontera]

With that, I'll turn the call over to Fred Leffler, our Chief Financial Officer. Fred?

[Fred Leffler, CFO at Biofrontera]

Thank you, George, and good morning, everyone. I'll walk through our results for the third quarter and first nine months ended September 30th, 2026. All comparisons are to the same prior year period unless otherwise noted. The full reconciliation of GAAP to non-GAAP measures is included in our press release that we filed earlier this morning and is available on our website. Revenues for the third quarter were $9.1 million compared to $7.0 million last year, an increase of 29.8%. As George described, unit volume grew 23.3% or approximately $1.6 million, with the balance from the fourth quarter 2025 price increase and higher device sales. Substantially all of that volume growth reflects approximately $1.6 million of orders placed in early July ahead of the ITC effective date.

[Fred Leffler, CFO at Biofrontera]

The increase reflects Ameluz unit volume growth. For the first nine months, revenues were $31.2 million, up 26.6% from $24.6 million. The increase reflects Ameluz unit volume growth of approximately $5.5 million, including about $3.6 million from accelerated order timing and approximately $0.7 million from the fourth quarter 2025 price increase. Cost of revenues for the quarter were $2.3 million compared with $2.0 million, producing a gross profit of $6.7 million and gross margin of 74.4% compared to 70.7% the year before in 2025, an improvement of approximately 370 basis points. The improvement comes from the cost structure we put in place with the strategic transaction that Hermann mentioned earlier, which is Ameluz direct cost plus a 12% earn out on net revenue. The third quarter margin is lower than the roughly 80% we reported in the first half for a couple reasons.

[Fred Leffler, CFO at Biofrontera]

First, lamp and device costs were $0.4 million higher, driven by higher XL sales and $0.3 million of RhodoLED lamp inventory write-downs, including a $0.2 million write-down of XL long-term raw materials and work in process. For the nine months, gross margin was 78.0% compared to 67.7% in the prior year. Selling, general, and administrative expenses, including the related party line, were $12.5 million for the quarter compared to $10.4 million the year before, an increase of $2.1 million.

[Fred Leffler, CFO at Biofrontera]

The main drivers were a $1.1 million increase in general and administrative expense, mostly $0.9 million of higher legal fees related to the ITC matter and $0.7 million of costs in lamp manufacturing and in regulatory and product affairs, which are functions we took over with the strategic transaction last year, and $0.5 million of higher direct sales expense, namely commissions on higher Ameluz volumes, which were partly offset by $0.3 million of decreases in related party SG&A. For the nine months, SG&A was $33.2 million compared to $29.6 million, an increase of $3.5 million. Research and development expenses were $0.5 million for the quarter compared to $0.9 million and $1.8 million for the nine months compared to $2.9 million, reflecting the substantial completion of our clinical trials. Patent remediation expense was $0.3 million in the quarter and $0.7 million for the nine months.

[Fred Leffler, CFO at Biofrontera]

Let me give you the full cost of the ITC matter to date outside of the legal fees since it sits in more than one line. Through September 30th, we have recognized total charges of $1.1 million, made up of $0.6 million of accrued remediation costs and $0.5 million of inventory write-downs. Of the remediation costs, $0.2 million was settled with inventory used in the remediation program, and $0.4 is paid or payable in cash. Net loss for the quarter was $6.4 million, or $0.42 per share, compared with a net loss of $6.6 million, or $0.62 per share last year. For the nine months, net loss was $11.8 million, or $0.89 per share, compared with $16.2 million in 2025, or $1.67 per share.

[Fred Leffler, CFO at Biofrontera]

Adjusted EBITDA for the quarter was negative $5.5 million compared with negative $6.0 million, an Adjusted EBITDA margin of negative 60.9% against a negative margin of 80.7% last year. For the nine months, Adjusted EBITDA was negative $9.3 million compared to negative $15.5 million, a margin of negative 29.7% against negative 63.0%. The third quarter is seasonally our weakest, and this year, it also absorbed some ITC legal spend, which was not backed back into Adjusted EBITDA. Turning to the balance sheet and liquidity, as of September 30th, 2026, we had cash and cash equivalents of $3.2 million compared with $6.4 million at December 31st, 2025. Cash used in operating activities for the nine months of 2026 was $3.2 million, down from $11.0 million a year ago. Total liabilities were $21.7 million compared to $18.1 million at year-end 2025.

[Fred Leffler, CFO at Biofrontera]

Our only outstanding indebtedness is about $4.7 million of convertible notes net, maturing in November of 2027. We have no bank or long-term debt. As a result of Q3, our stockholders' deficit was $0.2 million at September 30th, 2026. We do not currently meet minimum stockholders' equity requirements of Nasdaq, but we expect to file our Form 10-K and intend to submit a plan to regain compliance as needed. I want to address the going concern disclosure directly as well. As described in our Form 10-Q, which we will file later today, management has concluded that substantial doubt exists about the company's ability to continue as a going concern for at least 12 months from the issuance of our Form 10-Q. Our plan to mitigate has four parts. They will be laid out in the que.

[Fred Leffler, CFO at Biofrontera]

Continuing to grow Ameluz revenue, with Q4 typically our strongest quarter, including supported by the sBCC launch while controlling expenses. Obtaining and drawing on a working line of credit. The next $1.0 million milestone payment from our Xepi divestiture, which we expect in December, and which depends on the purchaser achieving certain milestones, and if necessary, raising additional capital through equity or debt. Some of these are not within our control, and these plans have not alleviated the substantial doubt. With that overview of our financial results, we are now ready to take questions from our covering analysts. Operator?

[Operator]

Thank you. We will now begin the question-and-answer session from our covering analysts. 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. At this time, we will pause momentarily to assemble our roster. As a final reminder, if you'd like to ask a question, please press star then one at this time. Our first question today comes from Bruce Jackson at StoneX. Please go ahead.

[Bruce Jackson, Analyst at StoneX]

Hi, good morning, and thanks for taking my questions. I just wanted to look at the operating expense profile going into the fourth quarter. So third quarter had several special charges. Where do you see that core rate for cost of goods sold? So what type of gross margins are we going to be looking at? Then with the SG&A, maybe you could give us kind of a rough indicator of where that might shake out.

[Fred Leffler, CFO at Biofrontera]

Yeah. Hi, Bruce. Yeah, thanks for asking. So on the gross profit, I expect that to be back around our 80% mark. Nothing to my knowledge for the fourth quarter should push that down like the charges did in Q3. With regarding to SG&A, generally, we've been doing, aside from the legal points that I mentioned, we've been doing an excellent job of managing our costs, doing what we need to do to support the business. So, I expect that to continue, and we'll manage the legal costs as needed.

[Bruce Jackson, Analyst at StoneX]

Okay. Then, you mentioned that you are putting together the reimbursement strategy for the superficial basal cell carcinoma indication. Is reimbursement going to be available when you launch that, and do you have a rough idea of what that might be?

[George Jones, Chief Commercial Officer at Biofrontera]

Yeah, I will take that. We believe that there will be a clear path to reimbursement upon launch of the indication. We are in the market right now working with some key customers, I will say, kind of confirming that strategy. Relative to exactly how much it is going to be for the customers, the tubes of Ameluz will be reimbursed as normal via the J-code, and then the procedure codes, we are finalizing kind of what we think that is going to be for the customer.

[Bruce Jackson, Analyst at StoneX]

Okay, got it. Thank you very much.

[Operator]

Thank you. That concludes our question-and-answer session. I would like to turn the conference back over to management for any closing remarks.

[Hermann Luebbert, CEO, Chairman, and Founder at Biofrontera]

Yeah, thank you, operator, and thank you to everyone who joined us today. Let me leave you with three takeaways. First, Ameluz is now the only PDT drug in the U.S. approved for skin cancer. Superficial basal cell carcinoma is our second U.S. indication, and we begin commercializing it later this quarter and into the first quarter of 2027. Second, the ITC matter is no longer limiting which customers we can serve. The XL-C is cleared, our customers are ordering again, and the remediation is on a defined path. Third, the third quarter shows the cost of getting here, and we are not hiding from it. Our cash position requires discipline, and Fred has told you how we plan to address it. What has changed is what we have to sell. Two indications today and a third filed, all delivered through the lamps and the sales force already in place.

[Hermann Luebbert, CEO, Chairman, and Founder at Biofrontera]

I want to thank our entire team for their dedication and hard work. I also want to thank our shareholders, the healthcare professionals who use our products, and most importantly, the patients whose lives we are helping to improve within the fight against skin cancers. Thank you for your continued support. Have a wonderful day.

[Operator]

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect, and have a wonderful day.

Participants

Executives

• Hermann Luebbert, CEO, Chairman, and Founder
• George Jones, Chief Commercial Officer
• Fred Leffler, CFO

Analysts

• Ben Shamsian, VP of Investor Relations at Lytham Partners
• Bruce Jackson, Analyst at StoneX