On Thursday, Biofrontera (NASDAQ:BFRI) discussed first-quarter financial results during its earnings call. The full transcript is provided below.
Benzinga APIs provide real-time access to earnings call transcripts and financial data. Visit https://www.benzinga.com/apis/ to learn more.
The full earnings call is available at https://event.choruscall.com/mediaframe/webcast.html?webcastid=Re1hZKm0
Summary
Biofrontera reported Q1 2026 product revenues of $10.1 million, a 17% increase from Q1 2025, driven by a 16% growth in Amelus unit volume.
Gross margin improved significantly to approximately 80%, up from 62% in the prior year quarter, reflecting a new cost structure post-strategic transaction.
Cash used in operations was nearly zero at $70,000, marking a substantial improvement from $4.1 million in Q1 2025.
The FDA accepted a supplemental NDA for Amylus PDT for superficial basal cell carcinoma with a PDUFA date of September 28, 2026.
Positive phase 3 results for actinic keratosis and phase 2 results for acne vulgaris were announced, with plans to discuss future studies with the FDA.
The company regained compliance with NASDAQ’s minimum bid price requirement.
SG&A expenses increased to $11 million, driven by higher sales activities and legal expenses.
Biofrontera aims to achieve cash flow breakeven in 2026, leveraging revenue growth and cost management.
Full Transcript
OPERATOR
Good day and welcome to Biofrontera Inc. First quarter 2026 financial result and Business Update Conference Call. All participant line will be in the 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 question. To ask a question you may press Star then one on a touch tone phone. To withdraw your question please press Star then two. Please note this event is being recorded. I would like to turn the conference over to Ben Shamsian, Investor Relations. Please go ahead.
Ben Shamsian (Investor Relations)
Good morning and welcome to Biofrontera Inc. first 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 Security 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 and in and are qualified by the cautionary statements contained in Biofrontera’s press releases and SEC filings, including the Company’s Quarterly report on Form 10-Q for the quarter ended March 31, 2026 and the company’s annual report on 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. Biofrontera believes these measures provide useful information for investors and 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 the defined as net income or loss excluding interest, income and expense, income taxes, depreciation and amortization and certain other non recurring or non cash items including changes in fair value of warrant, liabilities and stock based compensation. With that said, I would like to now turn the call over to Herman Lavert, CEO, Chairman and Founder of Biofrontera.
Herman Lavert (CEO, Chairman and Founder)
yes, thank you Ben, and thank you to everyone joining us this morning. The first quarter of 2026 was strong across our key metrics. We delivered product revenues of $10.1 million, an increase of approximately 17% compared to $8.6 million in the first quarter of 2025. This marks the first full quarter reflecting our new cost structure following the strategic transaction with biofantera ag, and the results demonstrate that our business model transformation is delivered as planned. These results further demonstrate the strength of our commercial execution and the growing adoption of Amylus PDT across the dermatology community. George Jones, our cco, will follow up about this in more detail. As a reminder, the strategic transaction, which closed in October 2025, gave Biofrontera Inc. Full ownership and control of all U.S. rights approvals and patents for Ameluz and Rhodonet, including the New Drug Application, the investigational New Drug Application, all manufacturing rights and contracts, and all intellectual property. The FDA formally transferred the NDA and IND to us in December 2025. Under the new earnout structure, we pay 12% of net sales when annual US Ameluz revenues are at or below $65 million and 15% when they exceed that threshold. This replaced a transfer pricing model that previously was 25% to 35% of revenue. The impact of this is clearly visible in our Q1 results. Our gross margin expanded to approximately 80% compared to approximately 62% in the prior year quarter and our cash used in operations was near zero at just 70,000, a dramatic improvement from 4.1 million used in operations in Q1 2025 and sets the path for cash flow break even this year. Fred Leffler, our cfo, will provide more detail on the financial performance in a few moments. Let me now turn to the significant clinical and regulatory progress we have made during and since the first quarter. First in superficial basal cell carcinoma in February 2026, we announced that the FDA completed its filing review and accepted our supplemental new drug application for Amylus PDT for the treatment of superficial basal cell carcinoma. The PDUFA target action date is September 28, 2026. If approved, Ameluz would be the first PDT drug approved to treat a cancer in the United States, representing a significant additional commercial opportunity for our platform and providing a significant advantage to what our direct competitor can do. Second, in actinic keratosis on the extremities, neck and trunk in February 2026, we announced positive and statistically significant top line results from our phase 3 clinical trial. The study met its primary endpoint demonstrating highly statistically significant superiority for Ameluz versus vehicle gel. Additionally, we announced the database log of the phase 1 pharmacokinetics study required for our FDA filing. Combined, these data support our plan to file a supplemental NDA in the third quarter of 2026 to expand the Ameluz label for the treatment of AK beyond the face and scalp on a treatment field of up to 240 square centimeters. With approximately 58 million American adults having at least one AK lesion treating extensive fields on the extremities, neck and trunk represents a very large addressable market for our installed base of RodoLED lamps. Third in moderate to severe acne vulgaris in March 2026 we announced the results of our phase two study with Ameluz PDT. The three hour incubation protocol does demonstrated a 58% reduction in inflammatory lesions with MLUs compared to 37% with vehicle gel. In the per protocol population, patient satisfaction was very high with 86% of patients stating they would choose PDT treatment. Again, based on these data, we plan to discuss the design of future phase three program with the FDA in the second half of 2026. Acne Vulgaris is a chronic condition affecting millions of adults and adolescents and we believe Ameluz PDT has the potential to offer a differentiated treatment option …
This post was originally published here
