Biofrontera (BFRI) Q1 2026 Earnings Transcript

Chief Executive Officer, Chairman, and Founder — Hermann Lubbert Chief Financial Officer — Eugene Leffler Vice President, Investor Relations — Ben Shamsian Ben Shamsian: Good morning, and welcome to Biofrontera Inc. s 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 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. All risks and uncertainties are detailed 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 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 income or loss excluding interest income and expense, income taxes, depreciation and amortization and certain other nonrecurring or noncash 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 Hermann Luebbert, CEO, Chairman and Founder of Biofrontera. Hermann? Hermann Lubbert: 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 Biofrontera 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 Ameluz 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 RhodoLED, 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 U.S. Ameluz revenues are at or below $65 million and 15% when they exceed that threshold. This replaced the 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 0 at just $70,000, a dramatic improvement from $4.1 million used in operations in Q1 2025, and sets the path for cash flow breakeven 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 Ameluz 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 III

Biofrontera (BFRI) Q1 2026 Earnings Transcript

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Biofrontera (BFRI) Q1 2026 Earnings Transcript

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