Biofrontera Inc.

Good day and welcome to the BioPontera's first quarter of 2025 financial results and business update conference call. All participants will be in 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 questions. 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 now like to turn the conference over to Andrew Barwicki. Please go ahead.

Good morning and welcome to BioFrontera Incorporated's first 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 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 BioFrontier'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, May 16, 2025. BioFrontier 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. BioFrontier 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 that was issued yesterday. More specifically, 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 non-recurring or non-cash items. With that being said, I would now like to turn the call over to Herman Louvert, CEO, Chairman and Founder of BioFrontera. Herman?

Thank you, Andrew, and my thanks to everyone joining us this morning. On today's call, I'll provide an overview of our business during the first quarter. Fred Leffler, our CFO, will follow with a discussion on financial results, and then both of us will be happy to answer questions after our prepared remarks. Starting with the business update, our first quarter was a busy and exciting period for us. We continued our revenue growth while keeping our costs under control. Total revenues for the first quarter of 2025 were 8.6 million, a 9% increase from the same period of the prior year. Both our cost of revenue and our operating costs were lower than in the same period of the previous year, as Fred will explain in much more detail. We strongly believe Our past investments, execution, and tremendous efforts to increase the effectiveness of our sales force will allow us to achieve record revenues in 2025 without increasing our costs. On top of the positive financial development, we achieved several more milestones. An important development for our long-term future is the recent granting of a patent on the new formulation of Amelus. This new formulation, which lacks the potential allergen propylene glycol, had already been approved by the FDA and is in use since last year. Having no patent protection on this amylose formulation until December 2043 gives us another 18.5 years of protection from generic competition. We announced the enrollment of the final patient in the Phase III clinical trial evaluating amyloose for the treatment of mild to moderate actinic keratosis on the extremities, neck and trunk. Currently, our label is restricted to treatments of AK on the face and scalp. The goal of this study is to extend the label to the entire body. This represents another important cornerstone in our overall strategy complementing the use of free tubes and the availability of the larger lamp, both launched in 2024. As a last building block for this label extension, FDA has requested a Phase I pharmacokinetics study with 16 patients, which started in January and is currently recruiting. For the more We reached a key milestone in the Phase III study for the use of amylose and rhodolat PDT in the treatment of superficial basal cell carcinoma. The last patient completed the one-year follow-up visit, which is required for FDA approval in December 2024. We believe amylose has additional applications other than actinic keratosis, and we are committed to explore these opportunities. Our next goal is approval for superficial basal cell carcinoma. I can tell you that being able to treat actinic keratosis, which are precancerous lesions that may progress to squamous cell carcinoma, is a wonderful feeling, but to expand beyond that to treating certain skin tumors is very encouraging and exciting for all of us here at BioFrontera. We expect to submit the new data to the FDA in the second half of this year. Following the approvals for AK on the entire body and for superficial basal cell carcinoma, we are aiming at getting amylose approved for the treatment of moderate to severe acne. Acne is the most frequent indication seen by dermatologists, and the treatment options available for the more severely affected patients suffer from very considerable side effects. This creates a significant medical need for these patients. Our ongoing phase two study in this indication is close to completing patient, or it has completed patient recruitment, and data will be available towards the end of the year. The further development plan will be discussed with the FDA once the data of this study become available. As I look back on the first quarter, In addition to the achievements and milestones, we were able to lower the cost of revenues, total operating expenses, and SG&A. We continue to monitor and be very prudent in all aspects of our business and operations. Additionally, we increased EBITDA and gross profit, all of which support our goal of reaching break-even as quickly as possible. We believe we have built the foundation with the sales team and back end support to continue to improve our results on a consistent basis. With that, I'll turn the call over to Fred to walk through the financial details of the second quarter. Fred?