Biofrontera Inc. Common Stock 2026 Q2 Earnings Call

Please go ahead. Good morning, and welcome to Biofrontera Inc.'s second 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 of 1995. 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. Forward-looking statements on today's call include statements regarding the company's full year 2026 revenue goals, the anticipated effects of the U.S. International Trade Commission orders, and the company's remediation plan, the company's liquidity and the ability to continue as a going concern, the outcome of pending patent proceedings, and the potential approval and launch of new indications for Ameluz.

All risks and uncertainties are detailed and are qualified by the cautionary statements contained in Biofrontera's press release and SEC filings, including the company's quarterly reports on Form 10-Q for the quarter ended June 30, 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 and 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, patent remediation expense, and the related inventory write-down 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. Yes. Thank you, Ben.

Thank you to everyone joining us this morning. The second quarter of 2026 was the strongest operating Q2, and the first half year was the strongest H1 in the company's history as a standalone U.S. business. Net product revenue grew 33% to $12 million. Gross margin reached approximately 80% compared to approximately 71% a year ago, and adjusted EBITDA came to $200,000 of breakeven against a loss of $5.1 million in Q2 of last year. These strong results in Q2, which for us is traditionally a weaker quarter, are not just one quarter out of the ordinary. They reflect the buildup of a commercial organization that is executing along with the expense discipline across the entire organization. We are seeing the pace of reorders from our physician accounts accelerate, which reflects the strength of underlying demand generation.

George and Fred will take you through the details in a moment. The results also further reflect the strategic transaction we completed in October 2025, which gave Biofrontera full ownership and control of all U.S. rights, approvals, and patents for the Ameluz and RhodoLED portfolio and replaced the transfer pricing model of 25%-35% of revenue with a 12% earn-out on net sales. Before diving into the business, I want to address the U.S. International Trade Commission matter because I expect that it's on your minds. On May 6th, the commission issued its final determination, finding a violation of Section 337 with respect to two Sun Pharmaceutical patents covering certain components of our RhodoLED XL lamp.

In their decision, the commission contradicted the conclusion of the U.S. Patent and Trademark Office's Patent Trial and Appeal Board, which, in agreement with our belief, had previously found every challenged claim of one of the patents unpatentable. The commission issued a limited exclusion order and cease and desist orders, which took effect on July 7. We can no longer import or sell the current RhodoLED XL lamp in the United States, and we are restricted from selling Ameluz for use with the RhodoLED XL. Three things you should understand about the scope of this. First, this affects the XL lamp. It does not in any way affect the original BF-RhodoLED lamp, which represents the substantial majority of our installed lamp base. Physicians using those lamps are unaffected, and Ameluz sales to accounts with a BF-RhodoLED lamp continue normally.

Second, we have a remediation plan designed to allow selling a modified version of our XL lamp that is outside the scope of both Sun Pharmaceutical patents. We recorded approximately $500,000 in the first quarter as our best estimate of the remediation cost, and that estimate has not changed. Because the substantial majority of our installed lamp base is unaffected, and we expect to get approval for providing a modified version of the RhodoLED XL that is outside the patent space, we expect the exclusion order to affect the timing of orders rather than total demand. Third, and finally, we are not finished contesting this. We retain the right to appeal the commission's determination to the U.S. Court of Appeals for the Federal Circuit. I will not speculate on how those proceedings will resolve or when.

What I will tell you is that while pursuing every avenue available to us, our commercial plan does not depend on winning any of them. Our commercial success will be because of our continued dedication to doctors and patients, as well as investment in developing Ameluz and PDT to be used in more indications. Now let me turn to the clinical pipeline because it is the clearest picture of how this company will grow in 2027 and beyond. First, superficial basal cell carcinoma. The FDA accepted filing of our supplemental new drug application for Ameluz PDT for the treatment of superficial basal cell carcinoma with a PDUFA target date of September 28, 2026.

If approved, Ameluz will be the first PDT in the U.S. approved for the treatment of cancerous skin tumors, and we expect a full launch in Q1 of 2027, with initial outreach to customers during Q4 of 2026. That launch would go directly into our existing installed base of BF-RhodoLED lamps and our existing dermatology call points. The commercial infrastructure is already in place. Second, actinic keratosis on the extremities, neck, and trunk. Earlier this year, we announced positive and statistically significant top-line phase III results with the study meeting its primary endpoint. These data support our plan to file a supplemental NDA around the end of the third quarter of 2026 to expand the Ameluz label beyond AKs on the face and scalp to a treatment field of up to 240 square centimeters. We anticipate FDA approval in Q3 2027.

With approximately 58 million American adults having at least one AK lesion, extending treatment to the extremities, neck, and trunk, and a larger area meaningfully expands the addressable use of every lamp already in the field. Third, moderate to severe acne and beyond. Our phase IIb study showed a 58% reduction in inflammatory lesions with Ameluz compared to 37% with vehicle, and 86% of patients said they would choose PDT treatment again. We are currently in the process of prioritizing and designing our next phase of clinical development, aiming at expanding the addressable market for our products, and acne will be an important part of this discussion. We'll keep you updated as these plans will evolve. Taken together, sBCC expected to launch in the first quarter of 2027, relevant AK label extensions anticipated in Q3 2027, and an acne program advancing towards phase III.

Each of these growth avenue through the same installed lamp and customer base and the same sales force we have already built and paid for. That is the growth model for 2027 and beyond. More approved users flowing through infrastructure that is already in place. I would now like to turn the call over to George Jones, our Chief Commercial Officer.

George? Thank you, Hermann, and good morning, everyone.