Biofrontera Inc.

and welcome to the BioFrontera Inc. Second Quarter 2025 Financial Results and Business Update Conference Call. Today, all participants will be in a listen-only mode. Should you need assistance during today's call, please signal for a conference specialist by pressing the star key followed by zero. After today's presentation, 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 that today's event is being recorded. I would now like to turn the conference over to Andrew Barwicki, Investor Relations. Please go ahead, sir.

Thank you. Good morning, and welcome to BioFrontera Incorporated's second 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 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 in 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 this live broadcast, which is August 14, 2025. BioFrontera undertakes no obligation to revise or update any forward-looking statements or 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 we issued. Please note, management will be referencing adjusted EBITDA, a non-GAAP financial measure defined as net income or loss excluding interest, income, and expenses, income taxes, depreciation, and amortization, and certain other non-recurring or non-cash items. With that said, I would like now to turn the call over to Herman Louvert, CEO, Chairman, and Founder of BioFrontera.

Thank you, Andrew, and thank you to everyone joining us this morning. I'm very pleased to share that BioFrontera has delivered record-breaking results this quarter and throughout the first half of 2025. I am here with Fred Leffler, our CFO, And we'll let Fred discuss the numbers in a few minutes while I focus on the actual business and the things that contributed to those numbers and our future. First and foremost, two very gratifying quarters were driven by the changes in our approach to our business in 2025, which turned out to be successful. And for the first time, we sold more than 50,000 tubes of Amelus in the first half of the year. We transformed our customer segmentation, focused our strategy and used more extensive data analysis to support our sales team effectively. Furthermore, we have changed the hiring approach for our sales team, giving attitudinal factors and emotional intelligence priority over dermatology experience. I'm also pleased. to say that 40 Rodolat XL lamps were placed at physician offices during the first half of 2025. These include installations at facilities that we have not been in before, as well as locations throughout the United States that now have multiple lamps in one office. As I have said many times in the past, lamp placements are the leading indicator for future growth and we now have more than 700 out in doctors' offices. It is clear that dermatologists are seeing the promising and viable results as they are prescribing amylose for more and more patients. A transformational change for our commercial basis was the major restructuring of our relationship with BioFrontera AG by which BioFrontera Inc. becomes completely independent of BioFrontera AG. The agreement includes the transfer of all rights and obligations for the U.S. market for Amelus and the Rodolet lamp series to BioFrontera Inc. We are in the process of transferring all U.S. IP, the FDA approvals, and the contracts with third-party manufacturers, as well as the internal lamp manufacturing. Completing this will take a while, as some of these functions require agency registrations, but the financial consequences are already in place. Along with organizing manufacturing on our own, the previous transfer price for Amalus, which was 25 to 35% of our sales, depending on year and indication, was replaced by a 12% royalty in years where Amalu's sales were less than 65 million and 15% above. Already last year, when we took our clinical trial over clinical trial responsibility on June 1, 2024, we negotiated a reduced transfer price reflected in the cost of revenue for the first six months which were about 2.6 million lower than in the previous year, mostly due to the reduced transfer price. Shifting to the royalty model now will not only dramatically decrease our cost of sales further, but also significantly delay the time of the payments. The importance of this for our future was recognized by our investors who financed this transformation with the required $11 million. By now, Amaluz in combination with photodynamic therapy using our Rodelet lamps is a proven and highly effective way of treating a tinnitus keratosis of mild to moderate severity on the face and scalp. This is our driving force and one that we are so proud of as we run our day-to-day operations. As we look to the future, as of July 1 this year, CMS has officially listed Amaluz in its MUE files for the use of up to three tubes, which is 600 units per treatment. This follows a change in the patient information of Amaluz, which the FDA has approved in the fall of 2024. Doctors can now rely on officially being reimbursed for the use of up to three tubes per treatment, which will be important for the treatments of AK on face and scalp, but even more for treatments of AK on other larger sites on the rest of the body. Such treatments are outside of our approved indication so far. However, during this reporting period, We have completed enrollment in a phase three study to demonstrate the efficacy and safety of Omeluz for treating actinic keratosis on the trunk, neck, and extremities. Once the results become available, we plan to submit them to the FDA to expand our label and allow doctors to treat AK on the entire body. In parallel, We aim to include new indications into our label. The first one is going to be superficial basal cell carcinoma. Our phase three trial for this indication is completed, including the one-year follow-up data that the FDA has requested for this tumor indication. We expect this to offer a non-invasive treatment option with high efficacy and very positive cosmetic outcomes which could benefit many patients. Up to now, no PDT drug has been approved in the US for the treatment of a tumor disease. Currently, Amalus is also only indicated to treat precancerous skin lesions, which may progress to invasive skin cancers. And extending this to treating potentially infiltrating tumors is an exciting development, both scientifically and commercially. We are also very encouraged about the potential for amylose to be an effective treatment for acne vulgaris. Acne is a chronic inflammatory skin condition affecting the piloserbaceous unit, which results from a combination of factors. While it's a very common condition during adolescence, it is becoming increasingly common in adults and can persist even into the 40s and 50s. We believe from the data we see so far that Amalus has the potential to effectively treat this affliction as well. In the reporting period, we have been able to complete patient enrollment in a phase two trial, treating moderate to severe acne, and we are now waiting for the last patient to finish their treatment for us to be able to analyze the data. Earlier this year, we received patent approval for the new improved formulation of Amelus, extending patent protection of the drug through December, 2043. BioFrontera is the only company organizing FDA controlled clinical studies for PDT in dermatology in the US. And the extended patent life is relevant to recover the investment and profit from the resulting possibilities. I would like to thank our entire team for their continued dedication to execution and growth, which has enabled us to deliver the strong results Fred will now talk about. I also want to thank our shareholders for their confidence, in particular Roselyn Advisors and A Capital Management for their leading role in the $11 million investment which allowed us to fund the restructuring of our relationship with BioFrontera AG. At this time, I am pleased to turn the call over to Fred to go through the financial details of the second quarter and first half. Fred?