Biofrontera Inc.

Welcome to the BioConterra Inc. fourth quarter and full year 2025 financial results and business update conference call. At this time, all participants are in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's prepared remarks, 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 Ben Shamsian with Litham Partners Investor Relations. Please go ahead.

Thank you. Good morning and welcome to Bayer Frontera's fourth quarter and full 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 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 BioFrontier's press releases and SAC filings, including the company's annual report on Form 10-K for the year ended 12-31-2025. Also, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast. 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. 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 also available on the company's website at biofrontera-us.com under the investor relations section. Please note management will be referencing adjusted EBITDA and 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 including changes in fair value of warrant liabilities, stock-based compensation, gain on sale of assets, health for sale, and expense issuance costs. With that said, I would now like to turn the call over to Herman Lubert, CEO, Chairman, and Founder of BioFrantera. Herman?

Yeah, thank you, Ben. And thank you to everyone joining us this morning. Fiscal year 2025 was a transformational year for BioFrontera. I'm proud to say that we delivered record annual revenues of $41.7 million, representing about 12% growth over the prior year, capped by a record fourth quarter in which we generated revenues of $17.1 million, the highest quarterly revenue in our company's history. representing approximately 36% year-over-year growth. These results demonstrate the strength of our commercial execution and the growing adoption of amylose PDT across the dermatology community. As a consequence of the amendment in the contractual relationship with our former parent company, BioFrontera AG, which I'll explain in a few minutes, Q4 2025 was highly profitable for BioFrontera Inc., with an adjusted EBITDA of $4.9 million and an additional capital gain of $700K from the CSEPI investment divestment, resulting in a net income of $5.6 million. Let me take a moment to summarize what we accomplished in 2025 which resulted in this profitable fourth quarter and sets the stage for an exciting 2026 and beyond. In October 2025, we closed a new asset purchase agreement with our former parent company, BioFrontera AG. The financial consequences were active already as of June 2025. This transaction is one of the most significant milestones in our history. We acquired all U.S. rights, approvals, and patents for Amelus and Rodolat, including the new drug application, the investigational new drug application, all manufacturing rights and contracts, and all intellectual property. In December 2025, the FDA formally transferred the NDA and IND to us, giving BioFrontera Inc. full regulatory control in the United States. We also completed the transfer of 11 US patents, 10 US patent applications, and 19 international filings and registered designs. The financial implications of these transactions are significant. The new royalty or earn-out structure is 12% when annual US MLS net sales are at or below $65 million, and 15% in years where they exceed that threshold. This replaces a transfer pricing model that previously ranged anywhere from 25% to 35% of revenue. This change has already begun to improve our gross margin profile, leading to the highly profitable Q4, and Fred will provide more detail on the impact in a few moments. To support the AG transaction and our continued growth, we secured $11 million in funding through a private placement of Series C preferred stock led by Rosalind Advisors and Ake Capital Management. These self-care-focused institutional investors share our conviction in the long-term value of the Amalus platform. We also completed the sale of our Xeppy antibiotic cream licensed to Peltos Therapeutics for initial proceeds of $3 million, with the potential for up to an additional $7 million in milestone payments. These transactions, combined with our strong fourth quarter revenue performance, gives us the resources and financial flexibility we need to execute on our plan. We made remarkable clinical progress across multiple forms in 2025, and that momentum has carried into early 2026. First, in superficial basal cell carcinoma, or SBCC, we submitted a supplemental new drug application to the FDA in November 2025. based on strong phase III data from our 187-patient randomized double-blind placebo-controlled study. Complete histological clearance was seen in 76% of these tumors with amylose PDT compared to 19% with placebo. Complete clinical clearance was achieved in 83% of the lesions compared to 21% with placebo. I am pleased to report that the FDA has accepted this filing, and we have a PDUFA target action date of September 28, 2026. If approved, Amiluz would be the first PDT drug approved to treat a tumor in the United States, representing an additional commercial opportunity. Second, inactivity keratosis on the extremities neck and trunk. The last patient completed the treatment phase in the third quarter of 2025, and the database was locked in January 2026. I'm very pleased to report that in February 2026, we announced positive phase three results. The study met its primary endpoint. Combined with the completed phase one pharmacokinetics study, We anticipate filing a supplemental NDA in Q3 of 2026 to expand the labor for amyloose to treat AK beyond the face and scalp on a treatment field of up to 240 square centimeters. With approximately 58 million American adults having at least one actinic keratosis lesion, treating extensive fields on the extremities, neck, and trunk represents a very large addressable market for our installed base of Rotolab lamps. Third, in moderate to severe acne vulgaris. The treatment phase completed in Q3 2025, and the database was locked in January 2026. Last week, we announced positive phase two results. The three-hour incubation protocol demonstrated a 58% reduction in inflammatory lesions with Amalus compared to 37% with VehicleJet. PDT patient satisfaction was very high, with 86% of patients stating they would choose PDT treatment again. Based on this data, we plan to discuss the design of a future Phase III program with the FDA in the third quarter of 2026. Acne vulgaris is a chronic condition affecting millions of adults and adolescents, and we believe Hermeluz PDT has the potential to offer a differentiated treatment option for the moderate to severe form of the disease. Our patent portfolio was significantly strengthened in 2025. we received approval for the new improved formulation of amylose, which removed the potentially allergenic propylene glycol, extending patent protection through December 2043. And just recently, we had positive news in our patent dispute with Sun Pharma. The US Patent Trial and Appeal Board issued a final written decision finding all claims of Sun Pharma's patent unpatentable that we had challenged. This decision is a positive outcome in defending our market position, though we note Sun Pharma may seek further review. I would now like to turn the call over to George Jones, our Chief Commercial Officer, to provide a more detailed update on our commercial execution. George?