Biofrontera Inc.

Good morning and welcome to the BioFrontera fourth quarter and fiscal 2024 financial results and business update conference call. All participants will be in listen-only mode. Should you need assistance, please signal your 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, this event is being recorded. I would now like to turn the conference over to Andrew Barwicki, Investor Relations Representative. Please go ahead.

Thank you. Good morning, and welcome to BioFrontier Incorporated's fourth quarter and fiscal year 2024 financial results and business update conference call. Actual results may differ materially. 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 BioFrontier'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. Also, this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 21st, 2025. 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 we issued earlier today. More specifically, 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 to turn the call over to Hermann Louvert, CEO, Chairman, and Founder of Biofrontera. Hermann?

Yeah, thank you, Endel, and my thanks to everyone joining up this morning. On today's call, I'll provide an overview of our accomplishments throughout 2024 and how our initiatives and execution have resulted in a record sales year. Fred Leffler, our CFO, will follow with a discussion on financial results, and then both of us will be available to answer questions after our prepared remarks. I am pleased with $37.3 million in sales in 2024. This represents an annual sales growth of 18.5% for Q4, and almost 10% for the entire year and is a record for our company. We strongly believe our past investments, business plan and execution will allow us to achieve another record year in 2025. The year included some further milestones that we are very pleased with. First and foremost, we placed 52 Rodolat XL lamps in the fourth quarter alone and 100 between the launch in June 2024 and the end of 2024. Providing a larger PDT lamp to our customers is an important milestone in our overall strategy to extend the use of Amelus PDT for treating mild to moderate actinic keratosis on the face and scalp and potentially further indications in the future that are currently in development. The state-of-the-art red light emitting LED lamp is designed to revolutionize the photodynamic therapy of actinic keratosis aimed at enhancing the ease of use for healthcare providers by being highly maneuverable and capable of accommodating various patient treatment positions. It provides clinicians with the ability to illuminate a larger treatment area in a single session, which is particularly advantageous for treating extensive fields with multiple actinic keratosis lesions. Second, we obtained FDA approval to use up to three tubes of Amalus per treatment. Amalus, a photosensitizing agent and proferin precursor, is FDA approved for use in combination with both Rodolat lamp models and for lesion-directed and field-directed treatment of actinic keratosis of mild to moderate severity on the face and scalp. Treating larger fields is a second milestone in our overall strategy and complements the availability of a larger lab. Third, we achieved significant results in a phase three study of Amelus photodynamic therapy regarding the treatment of superficial basal cell carcinoma. We believe Amelus has additional applications other than actinic keratosis, and we are committed to explore these opportunities. 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 thing. But to expand beyond that to treating non-melanoma skin tumors is very encouraging and exciting for all of us at BioFrontera. We expect to submit the new data to the FDA in the second half of this year. Additionally, early in 2024, We successfully negotiated the restructuring of agreements with our former parent company, BioFrontera AG, resulting in the transfer price of Amelus being reduced from 50% to 25% for all purchases in 24 and 25. I strongly believe this was accomplished through the demonstration of our strong commitment towards promoting PDT in the USA and exploring the many open opportunities of this wonderful therapy. As part of the renegotiated agreements, we took control of all clinical trials with Amelus in the USA. This allows us to speed up patient recruitment and the corresponding label expansions with the FDA. Just recently, we announced the recruitment of the final patient in our phase three study for mild to moderate actinic keratosis on the trunk, neck, and extremities. The goal is to extend our current label which is restricted to treatments of AK on the face and scalp, to the entire body. This represents another important cornerstone in our overall strategy, complementing the use of three tubes and the availability of the larger lamp. As a last building block for this label extension, FDA has requested a phase one pharmacokinetics study with 16 patients, which started in January and is currently recruiting. More long-term, we are aiming at getting amyloose approved for the treatment of moderate to severe acne. Our ongoing Phase 2 study in this indication is close to completing patient recruitment. The further development plan will be discussed with the FDA once the data of this study become available. Based on our recent successes, our continued improvements of Salesforce effectiveness positive customer feedback, and the heightened level of customer engagement, we are excited about how 2025 is shaping up for the company. With that, I'll turn the call over to Fred to walk through the financial details of the fourth quarter and full year. Fred?